CN116761650A - For integration and mode switching of respiratory equipment - Google Patents

Abstract

The present disclosure relates to systems and devices configured to integrate different respiratory therapies into a single system or to switch integrally between separate systems or devices delivering different therapies, such as anesthesia and high flow therapies. Aspects of the present disclosure relate to various systems, devices, apparatus, switching mechanisms, and multi-lumen tube assemblies for integrating control of these therapies and providing flexibility in how and where a user controls switching between therapies.

Description

For integration and mode switching of respiratory equipment

Technical field

The present disclosure relates to systems for delivering respiratory support to patients, as well as devices and systems that provide integration and switching between respiratory device functions. The present disclosure relates particularly, but not exclusively, to integration and switching between anesthesia ventilation modes and high flow modes of respiratory support.

Background technique

Patients can lose respiratory function during anesthesia or sedation, or more commonly during certain medical procedures. Prior to a medical procedure, the patient may be pre-oxygenated by a medical professional to provide a reservoir of oxygen saturation, and this pre-oxygenation and _CO2 flush/flush may be performed with high-flow respiratory support via a nasal cannula or other Patient interface implementation.

Once the patient is under general anesthesia, the patient must be intubated to ventilate the patient. In some cases, intubation is completed within 30 seconds to 60 seconds, but in other cases, especially when intubation is difficult to traverse the patient's airway (e.g., due to cancer, severe injury, obesity, or changes in neck muscles) spasm), intubation will take significantly longer. Although preoxygenation provides a buffer against desaturation, for prolonged intubation procedures it is necessary to interrupt the intubation process and raise the patient's oxygen saturation to a sufficiently high level. For difficult intubation procedures, the intubation process is interrupted several times, which is time-consuming and exposes the patient to serious health risks. Medical procedures such as the intubation method will be abandoned after approximately three attempts at intubation.

In operating rooms there are high flow systems for use during anesthesia or sedation procedures or other medical procedures. High-flow respiratory support has been found to be efficient at meeting or exceeding the patient's normal inspiratory needs, increasing the patient's oxygen delivery, reducing respiratory effort, or performing transnasal humidified rapid inflation ventilation (THRIVE). Preoxygenation using a high-flow system prior to the administration of anesthesia or sedation provides an oxygen reservoir and extends the safe apnea period. Additionally, high airflow can produce a flushing effect in the nasopharynx, such that the anatomical dead space of the upper respiratory tract is flushed by the high incoming airflow. This creates a reservoir of fresh gas available for each breath while minimizing rebreathing of carbon dioxide, nitrogen, etc. THRIVE delivers a high flow of breathing gas to the patient while the patient is apneic (which occurs when the anesthetic takes effect and before the patient is successfully intubated and mechanically ventilated). High-flow respiratory support refers to the delivery of heated and humidified respiratory gases to a patient via a non-sealed patient interface (e.g., nasal cannula) at a high flow rate that is typically intended to meet or exceed the patient's requirements when the patient is breathing spontaneously. Flow rate required for inhalation.

Once the patient is preoxygenated, anesthetic is delivered to the patient to sedate the patient prior to intubation. After intubation, anesthetics are also delivered to maintain the patient's anesthesia during the medical procedure. This delivery of anesthetic agent can be accomplished via injection or via aerosol/vapor, ie the latter can be achieved through the use of an anesthetic machine. Systems configured for use in anesthesia procedures typically include an anesthesia machine that includes a rebreathing system in which exhaled gases from the patient are returned to the machine. An anesthesia machine delivers anesthetic to sedate and/or maintain sedation of the patient via a sealing mask placed over the patient. Once the patient is sedated, the patient is intubated and then mechanically ventilated through an anesthesia machine that assists or replaces spontaneous breathing (anesthesia ventilation).

Reference herein to a patent document or any other matter held to be prior art as at the priority date of any claim shall not be taken as an admission that the document or other matter was known or that the information contained therein was part of common knowledge.

Contents of the invention

Currently, high-flow systems and anesthesia machines are separate systems, and there is no simple, efficient, and safe way to integrate these two systems and/or their functions into an anesthesia practice. This creates difficulties in efficiently and safely switching from one form of respiratory support to another during medical procedures that require the use of two devices. It would be useful to resolve or ameliorate one or more of these difficulties.

Viewed from one aspect, the present disclosure provides a system for delivering respiratory gases to a patient, the system comprising:

(a) a first respiratory device configured to deliver respiratory gas containing one or more anesthetic agents to the patient;

(b) a second respiratory device configured to deliver respiratory gas to the patient at a predetermined flow rate;

(c) A switching device operable to select an operating mode of the system, the operating mode being selected from the group consisting of:

(i) a first mode in which respiratory gas is delivered to the patient via the first respiratory device; and

(ii) A second mode in which breathing gas is delivered to the patient via the second breathing device.

Typically, in the second mode of operation, the respiratory gas delivered to the patient does not contain anesthetic agent.

In some embodiments, when the first mode is selected, the system directs the flow of respiratory gases in a first inspiratory flow path in which the first patient interface directs the respiratory gases into the patient's airway. And it is a sealed interface. Preferably, the first patient interface directs exhaled gases from the patient to an expiratory flow path that returns the exhaled gases via the first respiratory device to the first inspiratory flow path. The first patient interface may be a sealing mask or an endotracheal tube.

In some embodiments, when the second mode is selected, the system isolates the flow of respiratory gases from the first respiratory device to prevent anesthetic agent from being delivered to the patient. Preferably, when the second mode is selected, the system directs the flow of respiratory gas in a second inspiratory flow path in which the second patient interface directs respiratory gas into the patient's airway and the second The patient interface is a non-sealing interface such as a nasal cannula.

In some embodiments, the switching device includes a switching mechanism configured to vary the flow of respiratory gas in the system depending on selection of the first operating mode or the second operating mode. A switching mechanism may be located between the gas supply and the first and second breathing devices. In some embodiments, the switching mechanism includes one or more gas flow valves.

In some embodiments, the switching mechanism includes a gas delivery device that receives a gas supply including NO, _O2 , and air and has one or more breathing gas outlets. The gas delivery device may include one or more flow meters that control the flow of a gas including one or more of NO, _O2 , and air through the one or more breathing gas outlets. The one or more flow meters may control the flow of breathing gas through the one or more breathing gas outlets in response to selection of the first operating mode or the second operating mode.

In some embodiments, the gas delivery device includes a gas mixing element for combining NO, _O2 , and air in the proportions required by operation of the system in the first mode.

In some embodiments, the gas delivery device includes a common gas outlet that supplies breathing gas from the gas delivery device to the first breathing device and the second breathing device. The gas delivery device may comprise a first switching element coupled to the switching device and operable to control input to the common gas outlet, wherein:

(i) When the first mode is selected, the common gas outlet receives breathing gas from the gas mixing element; and

(ii) When the second mode is selected, the common gas outlet receives breathing gas from the flow meter.

In some embodiments, the first respiratory device and the second respiratory device may be integrated into a unitary machine. The integrated machine may include a humidifier configured to condition the respiratory gas to a predetermined temperature and/or humidity before the respiratory gas is delivered to the patient in the second mode. A humidifier may be located between the second respiratory device and the second patient interface.

In some embodiments, the gas delivery device includes a gas mixing element for combining NO, _O2 , and air in proportions required by operation of the system in the first mode or the second mode, and the gas The delivery device may further include a flow meter for controlling the flow of respiratory gas from the gas mixing element. Gas delivery equipment can include:

a first gas outlet supplying respiratory gas from the gas delivery device to the first respiratory device;

a second gas outlet that supplies breathing gas from the gas delivery device to the second breathing device; and

A first switching element coupled to the switching device and operable to prevent the flow of NO into the gas mixing element when the second mode is selected.

In some embodiments, the system further includes a second switching element coupled with the switching device and operable to control the flow of gas from the gas delivery device to the first breathing device and the second breathing device, wherein, ( i) when the first mode is selected, respiratory gas from the gas delivery device is directed only to the first gas outlet; and (ii) when the second mode is selected, respiratory gas from the gas delivery device is directed only to the second gas outlet exit.

In some embodiments, the gas delivery device includes a first switching element operable to allow respiratory gas to flow from the gas delivery device to the first breathing device when the first mode is selected. The second respiratory device may include a flow meter that receives a supply of gas including _O for delivery at a predetermined flow rate; and the system may include a second switching element operable to select a second mode allows respiratory gas to flow from the flow meter to the second patient port. The first switching element and the second switching element may be operatively coupled such that when the second mode is selected the first switching element prevents the flow of breathing gas from the gas delivery device to the first breathing device and the second switching element allows the flow of breathing gas from the gas delivery device to the first breathing device. meter flow to the second patient interface.

In some embodiments, the switching mechanism includes a gas diverter that receives a gas supply including an anesthetic gas and a breathing gas, the gas diverter having a first switching element and a second switching element, the first switching element and The second switching element is operable to control the flow of gas from the gas splitter to the first breathing device and the second breathing device depending on selection of the first operating mode or the second operating mode of the system. The first switching element may comprise a valve controlling the flow of anesthesia gas, said valve being open in a first mode and closed in a second mode. The second switching element may comprise one or more diverter valves directing breathing gas to the first breathing device in a first mode and breathing gas to the second breathing device in a second mode. Respiratory equipment.

In some embodiments, the switching mechanism includes: (a) a first switching element operable to direct flow _of O to the first respiratory device in a first mode and to direct a flow of O in a second mode to a second respiratory device; and (b) a second switching element responsive to the first switching element and operable to operate when the first switching element operates in the second mode Stop the flow of gas from the first device to the patient. The first switching element can be a diverter valve, for example.

In some embodiments, the first respiratory device and the second respiratory device are separate machines. The second respiratory device may include a humidifier configured to condition the respiratory gas to a predetermined temperature and/or humidity before the respiratory gas is delivered to the patient in the second mode.

In some embodiments, the first switching element and the second switching element are operably coupled for operation substantially concurrently with or following operation of the switching device. In other embodiments, the switching device includes a first switching element and a second switching element.

In some embodiments, the predetermined flow rate is selectable from an available range of about 20 L/min to about 90 L/min by user operation of the switching device. In some embodiments, the predetermined flow rate is selectable by the user from a plurality of predetermined available flows. Predetermined available flow rates may include at least, for example: 0L/min, 40L/min and 70L/min.

In some embodiments, the switching device is operable by a user to select to deliver a selected predetermined flow rate in a continuous flow or an oscillating flow. The switching means may include a rate selector operable by a user to control selection and/or delivery of a predetermined flow rate in the second mode of operation. In some embodiments, operation of the rate selector prevents delivery of respiratory gas from the first respiratory device to the patient. In some embodiments, the rate selector selects a rate of 0 L/min to operate to allow supply _of O to the first respiratory device and the rate selector otherwise operates to prevent delivery of anesthetic agent from the first respiratory device to the patient.

In some embodiments, the switching device includes a pressure control actuator configured to allow the breathing gas to pass through the first breathing device in response to an increase in breathing gas pressure in the flow to the second breathing device. flow in the device. In some embodiments, the switching device includes a pressure control actuator configured to prevent the breathing gas from flowing to the first breathing device in response to a decrease in breathing gas pressure in the flow to the second breathing device. flow in the device.

In some embodiments, the switching means further provides for user selection of a manual first operating mode or a mechanical first operating mode of the first respiratory device. For example, the switching means may comprise a three-way actuator providing for user selection of a manual first operating mode, a mechanical first operating mode or a second operating mode. Selection of the mechanical first mode may trigger the connection of the mechanical ventilator circuit to the first respiratory device by the system. Selection of the manual first mode may trigger the connection of the ventilator bag to the first respiratory device by the system.

In some embodiments, selection of the second mode of operation causes the system to substantially simultaneously: (i) prevent respiratory gas from flowing from the first respiratory device to the patient through the first inspiratory flow path; and (ii) cause respiratory gas to flow from the first respiratory device to the patient. The second respiratory device flows to the patient through the second inspiratory flow path.

In some embodiments, the system includes a controller that receives input from one or more sensors for detecting whether a breathing circuit coupled to the patient's airway is in contact with a first breathing device for use with the first breathing device. A patient interface or a second patient interface for use with a second breathing apparatus is associated, wherein the controller operates the switching means to select an operating mode based on the detected association of the breathing circuit.

The one or more sensors may comprise, for example, a pressure sensor arranged to measure back pressure in the first respiratory device and/or the second respiratory device, wherein the measured back pressure is indicative of passage of breathing gas through the substantially sealed When the patient interface is delivered to the patient, the controller determines that the breathing circuit is associated with the first patient interface. Alternatively or additionally, _the one or more sensors may include a _CO2 sensor associated with one or each of the first breathing circuit and the second breathing circuit, the first breathing circuit being associated with the second breathing circuit. A patient interface is associated with the second breathing circuit and the second patient interface is associated with the second breathing circuit, wherein the controller determines the breathing circuit in which the patient's exhaled gas containing a high concentration of _CO2 is present as the breathing circuit through which the breathing gas is delivered to the patient's breathing circuit. Alternatively or additionally, the sensor may include a proximity sensor.

In some embodiments, the switching device includes one or more actuators operable by a user, the one or more actuators including one or more of the following: buttons, switches, knobs, electronic inputs device, touch screen, voice-activated sensor and foot switch. One or more actuators may be located at or near the patient interface through which respiratory gases are delivered to the patient from the first respiratory device or the second respiratory device. In some embodiments, the one or more actuators include electronic input devices that are wirelessly coupleable with a controller of the system and positionable relative to the patient and/or the first and second respiratory devices. at multiple locations.

The switching device may include one or more switching mechanisms, which may include one or more mechanical, electronic, electromechanical and pneumatic switching mechanisms. In some embodiments, one or more switching mechanisms may be coupled with the switching device via one or more of wired and wireless connections. The switching mechanism may be operable to control one or more characteristics of the respiratory gas delivered to the subject selected from the group consisting of presence of volatiles, flow rate, gas composition, gas concentration, temperature and/or humidity.

In some embodiments, the second respiratory device is configured to deliver a flow of respiratory gas at a predetermined flow rate in the range of approximately 20 L/min to 90 L/min.

In some embodiments, operation of the system in the second mode excludes delivery of anesthetic agent in the breathing gas delivered to the patient. This can be achieved using any suitable means.

The first respiratory device may include one or more of the following: a _CO2 absorber configured to treat returning exhaled gases before they are recycled to the patient in the first mode; a pressure limiting valve configured to maintain a substantially stable pressure in the system in the first mode; a variable volume for displacing gas in the first mode; a fresh gas flow for supplementing anesthesia delivered to the patient in the first mode a gas; and a vaporizer for vaporizing the volatile anesthetic into the breathing gas delivered to the patient in the first mode.

The second respiratory device may include one or more of: a flow source configured to generate a flow of gas through the system; and a humidifier configured to deliver respiratory gas to the patient in the second mode The breathing gas is previously adjusted to a predetermined temperature and/or humidity.

Viewed from another aspect, the present disclosure provides a gas delivery device for use with a respiratory system, the gas delivery device comprising: (a) a first inlet for receiving a supply of anesthetic gas; (b) receiving a respiratory gas a second inlet of the supply; (c) a first outlet; (d) a second outlet; and (e) a manifold between the first and second inlets and the first and second outlets, the manifold providing access to the a first flow path to an outlet and a second flow path to a second outlet; wherein the gas delivery device is operable: (i) in a first configuration, wherein the first flow path is open and the second flow path closed; and (ii) in a second configuration, wherein the second flow path is open and the first flow path is closed.

In some embodiments, in the first configuration, the gas delivery device prevents the flow of anesthetic gas to the outlet. The first valve may control the flow of anesthetic gas in the manifold, wherein in a first configuration the first valve is open and directs the anesthetic gas to the first flow path and in a second configuration the first valve is closed. The second valve may control the flow of breathing gas in the manifold, wherein in a first configuration the second valve directs breathing gas to the first flow path and in a second configuration the second valve directs breathing gas to the first flow path. 2. Flow path. One or both of the first valve and the second valve may be operable to control the flow of gas therethrough.

In some embodiments, the gas delivery device includes a third inlet for receiving another supply of respiratory gas, wherein the respiratory gas supplied to the second and third inlets includes air and _O2 . The second valve may be operable to control the _O2 concentration in the breathing gas delivered to the first flow path and the second flow path.

In some embodiments, the gas delivery device is operable in a third configuration in which both the first flow path and the second flow path are open.

In some embodiments, the gas delivery device includes a switching device operable by a user to select a configuration for operation of the gas delivery device. Switching devices can be pneumatic, mechanical, electronic or a combination of these.

In some embodiments, the gas delivery device may be configured to be connected to a power source. In some embodiments, the gas delivery device may include a battery.

In some embodiments, the first outlet of the gas delivery device may be coupleable with the first respiratory device gas inlet. The first breathing device may be, for example, an anesthesia machine. In some embodiments, the second outlet of the gas delivery device may be coupleable with a second respiratory device gas inlet. The second respiratory device may be, for example, a high flow respiratory device.

The gas delivery device may include one or more switching elements for creating a first flow path and a second flow path. The switching element can be located on the first respiratory device. The switching element can be located on the second respiratory device. The switching element may be located on a patient interface through which breathing gas is conducted into the airway of the patient. The switching element may be activated in response to detection of a change in status detected by one or more system sensors. System sensors may include one of a pressure sensor, _CO2 sensor, _O2 sensor, flow sensor, gas concentration sensor, etc. The switching element may communicate wiredly or wirelessly with one or more other switching elements to control operation of the gas delivery device according to a configuration selected by the user.

In some embodiments, the gas delivery device includes an output module that provides one or both of a visual and audible indication of a configuration in which the gas delivery device is operated. For example, operation of the output module may be activated when the switching device is operated by the user to select the second configuration.

In some embodiments, the gas delivery device includes a gas mixer for combining the received gases in the proportions required to deliver the desired treatment.

Viewed from yet another aspect, the present disclosure provides a respiratory device operable to deliver respiratory gases to a patient in multiple modes, the respiratory device providing an inspiratory gas flow path and an expiratory gas flow path, wherein: (a) In a first mode, the respiratory device delivers respiratory gas including one or more anesthetic agents to the inspiratory gas flow path and receives return exhaled gas via the expiratory gas flow path; (b) in the first mode In the second mode, the respiratory device inhibits the flow of one or more anesthetics and delivers respiratory gas including _O2 to the inspiratory gas flow path at a predetermined flow rate without returning exhaled gas; and (c) in In transient mode, the breathing device inhibits the flow of one or more anesthetic agents and delivers a high flow of _O2 to the inspiratory gas flow path.

The respiratory device may include switching means operable to select an operating mode from a plurality of modes.

In some embodiments, the transient mode is only activated during operation when the actuator is stopped by normal bias. The respiratory device may include a button or trigger configured to be activated by a user to operate the respiratory device in a transient mode, wherein release of the button or trigger disables the transient mode.

In some embodiments, in the first mode, the respiratory device is operable to deliver respiratory gases including an anesthetic to the patient through a first patient interface that forms a sealed interface with the patient's airway, and to deliver exhaled gases through the expiratory gas flow path. The gas is returned to the breathing apparatus. The first patient interface may be a mask or an endotracheal tube.

In some embodiments, in the second mode, the respiratory device is operable to deliver respiratory gases to the patient through a second patient interface that forms an unsealed interface with the patient's airway. The second patient interface may be a nasal cannula, for example.

In some embodiments, the respiratory device may operate in a manual first mode of operation or a mechanical first mode of operation. The respiratory device may comprise switching means operable by a user for selecting a manual first operating mode, a mechanical first operating mode or a second operating mode. In some embodiments, selection of the manual first mode triggers connection of the manual ventilation bag to the first respiratory device.

In some embodiments, the respiratory device may be configured in gas flow communication with one or more of the following: a _CO2 absorber configured to process exhaled gases prior to recycling to the patient in the first mode Returned exhaled gas; a pressure limiting valve configured to maintain a substantially stable pressure in the system in the first mode; a variable volume for displacing gas in the first mode; a fresh gas flow for replenishment an anesthetic gas delivered to the patient in the first mode; and a vaporizer for vaporizing the volatile anesthetic agent into the respiratory gas delivered to the patient in the first mode.

In some embodiments, the respiratory device may be configured to be in gas flow communication with one or more of: a flow source configured to generate gas flow through the system; and a humidifier configured to The respiratory gas is adjusted to a predetermined temperature and/or humidity before being delivered to the patient in the second mode.

Viewed from yet another aspect, the present disclosure provides a system for delivering respiratory gas to a patient, the system receiving a supply of respiratory gas for delivery to the patient through an inspiratory gas flow path, and the system Coupled with a return gas conduit that returns exhaled gas from the patient, the system includes: a flow generator configured to generate a flow of gas through the system; and a switching actuator, the switching actuator may Operated to select a mode of operation of the system; wherein the system is operable in a first mode in which respiratory gas is delivered in a closed gas flow circuit and in a second mode in which The exhaled gas is returned to the system for rebreathing by the patient, in the second mode the respiratory gas is delivered in the open gas flow circuit without rebreathing.

In some embodiments, the flow generator is a blower operable to deliver a flow of gas at a flow rate compatible with delivering respiratory therapies, including anesthesia, ventilation, and high-flow respiratory support. The flow generator may be operable to deliver a flow of gas at a flow rate in a range of up to about 90 L/min.

In some embodiments, the switching actuator is operatively coupled with the flow generator, and operation of the switching actuator to select the first mode causes the flow generator to operate at a lower flow rate, such as less than 15 L/min.

In some embodiments, the switching actuator includes or is operably coupled with a switching mechanism, and in the first mode, the switching mechanism allows a first flow of fresh respiratory gas to flow to the system and allows exhaled gas to return to the system, and in the second mode, the switching mechanism allows a first flow of fresh breathing gas into the system and prevents exhaled gas from returning to the system. The switching mechanism may include any suitable mechanism, such as a flow diverter or a pressure controlled flow diverter.

In some embodiments, the switching mechanism is located upstream of the flow generator.

In some embodiments, the switching mechanism is operably coupled with the flow generator, and operation of the switching mechanism in the first mode causes the flow generator to operate at a lower flow rate.

The second mode may include a ventilator mode and a high flow mode.

In some embodiments, operation of switching the actuator to select a high flow mode causes the flow generator to operate at a flow rate sufficient to deliver high flow respiratory support. In some embodiments, operation of switching the actuator to select a ventilator mode causes the flow generator to operate at a flow rate consistent with patient ventilation.

In some embodiments, the system is configured to receive a supply of anesthetic gas for delivery to the patient in the inspiratory gas flow path in the first mode. The system may include a pressure limiting valve to maintain substantially stable gas pressure in the system. The system may be configured to receive a supply of anesthetic gas downstream of the flow generator or upstream of the flow generator. A return gas conduit may be coupled to the system downstream of the flow generator.

In some embodiments, the system includes a flow reflector that may be configured, for example, to collect anesthetic gas exhaled from the patient and return it to the inspiratory gas flow path during subsequent inspiratory phases.

When the second mode is selected, the system may be configured to prevent anesthetic gas from being supplied to the system.

The system may include a _CO2 absorber configured to treat returning exhaled gas before _the exhaled gas is recycled to the inspiratory gas flow path in the first mode. Alternatively or additionally, the system may include a humidifier configured to condition the respiratory gas to a predetermined temperature and/or humidity before the respiratory gas is delivered to the patient in the second mode.

Viewed from yet another aspect, the present disclosure provides a system for delivering respiratory gas to a patient, the system operable in a first mode and a second mode, wherein the first mode is included in the recirculated gas flow between the system and the patient's airway, and the second mode includes non-recirculated gas flow between the system and the patient's airway, the system comprising: (a) a first module , the first module including a first set of respiratory components; and (b) a second module including a second set of respiratory components, the second module configured to cooperate with the first module to Switching between the two modes; wherein the system is operable in the first mode when the first module is activated or coupled with the second module, and when the first module The system may operate in the second mode when a module is deactivated or disconnected from the second module.

In a first mode, the gas delivered to the patient in the recirculated gas flow may include an anesthetic agent.

The first set of respiratory components may include one or more of the following: a _CO2 absorber configured to treat returning exhaled gases before they are recycled to the patient in the first mode; a pressure limiting valve, It is configured to maintain a substantially stable pressure in the system in the first mode; a variable volume for displacing gas in the first mode; and a fresh gas flow for supplementing the gas delivered to the patient in the first mode. an anesthetic gas; and a vaporizer for vaporizing the volatile anesthetic agent into the respiratory gas delivered to the patient in the first mode.

The second set of respiratory components may include one or more of the following: a flow source configured to generate a flow of gas through the second set of respiratory components; an inspiratory conduit; and a patient interface configured to transfer gas from a non-recirculated gas flow directed to the patient's airway; and a humidifier configured to condition the respiratory gas to a predetermined temperature prior to delivery of the respiratory gas to the patient in the second mode and a filter upstream of the patient interface and/ or humidity.

The first module may include a first gas outlet and a first gas inlet, and the second module may include a second gas inlet and a second gas outlet, wherein the first gas outlet may be coupled with the second gas inlet, and the first gas inlet may Connected to the second gas outlet.

In some embodiments, operation of the system in a first mode allows a first flow of fresh breathing gas to flow to the system and allows exhaled gas to return to the system, and the second mode allows a first flow of fresh breathing gas to flow into the system , and prevents exhaled air from returning to the system.

In some embodiments, operation of the system in the second mode prevents release of anesthetic agent from the system. The second mode may include a ventilator mode and a high flow mode.

The second module may be configured to receive a supply of breathing gas independently of the first module.

Viewed from yet another aspect, the present disclosure provides a system for delivering respiratory gas to a patient, the system comprising: a flow source configured to generate in a gas delivery circuit through the system gas flow; and a switching mechanism forming part of the gas delivery circuit; wherein the gas delivery circuit has an inspiratory gas flow path and an expiratory gas flow path, and the switching mechanism is configured to operate according to the first Selection of an operating mode in which the inspiratory gas flow path is in fluid communication with the first patient interface or a second operating mode switches between gas flow paths in the gas delivery circuit where the inspiratory gas flow path is in fluid communication with the first patient interface. The inspiratory gas flow path is in fluid communication with the second patient interface in the second mode of operation.

The first patient interface may form a substantially sealed interface with the patient's airway and receive exhaled gases from the patient. The second patient interface may form a non-sealing interface with the patient's airway.

In some embodiments, the switching mechanism includes one or more of an airflow diverter, a bistable switch, a pneumatic switch, a rotary switch, a lever, a knob, or other user-operable actuator. The switching mechanism may be operable by a user to switch between inspiratory gas flow and expiratory gas flow in the gas delivery circuit.

In some embodiments, the system includes one or more sensors configured to monitor one or more properties of the gas in the gas delivery circuit and control the control based on the one or more monitored properties. Operation of the flow generator. For example, these characteristics may indicate one or more of flow, pressure, and _CO2 . In some embodiments, when one or more sensors indicate respiratory gas flow to the first patient interface, the system controls operation of the flow source to produce a low flow. In some embodiments, when one or more sensors indicate respiratory gas flow to the second patient interface, the system controls operation of the flow generator to generate a high flow rate.

In some embodiments, the system is configured to receive user input to select a first mode of operation in which the flow source generates a low flow rate below a predetermined flow rate, or a second mode of operation in which A mode in which the flow source generates a high flow rate equal to or higher than a predetermined flow rate, wherein the switching mechanism operates in response to a flow rate of gas in the suction gas flow path as generated by the flow source. The switching mechanism may direct flow to the first patient interface in response to a low flow of gas in the inspiratory gas flow path. The switching mechanism may direct flow to the second patient interface in response to a high flow rate of gas in the inspiratory gas flow path.

In some embodiments, the switching mechanism is provided by operation of the first patient interface and the second patient interface, wherein the first delivery mode is selected when the first patient interface and the second patient interface are applied to the patient simultaneously, and wherein, The second delivery mode is selected when only the second patient interface is applied to the patient. In some embodiments, the first patient interface is a sealing mask and the second patient interface is a nasal cannula adapted for operation including applying the sealing mask over the nasal cannula. Thus, the first patient interface may be a mask configured to form a sealing interface over the second patient interface being a nasal cannula. In some embodiments, the sealing mask is inoperable when the sealing mask is not applied over the nasal cannula, and the second delivery mode is enabled when only the nasal cannula is applied to the patient.

In some embodiments, inspiratory gas flow is directed to the patient through one or both of the first patient interface and the second patient interface using the first patient interface and the second patient interface simultaneously in the first mode, and Return expiratory gas from the first patient interface to the expiratory gas flow path.

In some embodiments, the first patient interface is in fluid communication with the anesthetic gas reflector.

In some embodiments, the system includes one or more of the following: a _CO2 absorber configured to treat returning exhaled gas before the exhaled gas is recycled to the patient in the first mode; a pressure limiting valve , which is configured to maintain a substantially stable pressure in the system in the first mode; a variable volume that is used to displace the gas in the first mode; a fresh gas flow that is used to supplement the delivery to the patient in the first mode an anesthetic gas; and a vaporizer for vaporizing the volatile anesthetic into the respiratory gas delivered to the patient in the first mode.

In some embodiments, the system includes one or more of: a flow source configured to generate a flow of gas through the system; and a humidifier configured to deliver respiratory gas in the second mode The breathing gas is adjusted to a predetermined temperature and/or humidity before reaching the patient.

Viewed from yet another aspect, the present disclosure provides a switching mechanism forming part of a gas delivery circuit for delivering respiratory gas to a patient, the switching mechanism being configured to operate in accordance with a first mode of operation or a second mode of operation. Mode selection switches between an inspiratory gas flow path in the gas delivery circuit, the inspiratory gas flow path being in fluid communication with the first patient interface in the first operating mode, and an expiratory gas flow path in the second operating mode. The inspiratory gas flow path is in fluid communication with the second patient interface in the operating mode.

In some embodiments, the switching mechanism may be user-operable and may include one or more of the following: an airflow diverter, a pneumatic switch, a rotary switch, a lever, a knob, or other user-operable actuator .

In some embodiments, the switching mechanism may operate in response to a flow of gas in the suction flow path, wherein a high flow of gas prompts selection of the second operating mode. In some embodiments, the switching mechanism may be configured to operate in response to a flow of gas in the suction flow path, wherein a low flow of gas causes the switching mechanism to switch to the first operating mode, and wherein a high flow of gas causes The switching mechanism switches to the second operating mode.

Viewed from yet another aspect, the present disclosure provides a multi-lumen assembly for use with a respiratory support system, the multi-lumen assembly having a plurality of conduits, the plurality of conduits comprising: (a) a first an inspiratory conduit having a first conduit inflow end connectable to a first gas outlet of the respiratory support system; (b) a second inspiratory conduit having a second inflow end connectable to a second gas outlet of the respiratory support system; a conduit inflow end; and (c) an expiratory conduit having an expiratory conduit outflow end coupleable with an expiratory gas inlet of the respiratory support system.

The first suction conduit may have a first conduit outflow end coupleable with a first patient interface configured to sealingly engage and direct flow into the patient's airway. The second suction conduit may have a second conduit outflow end coupleable with a second patient interface configured to direct flow into the patient's airway and which is a non-sealing interface.

In some embodiments, at least a length of the plurality of conduits may be coaxially arranged.

A mechanism may be provided to maintain at least a length of a plurality of conduits in a group. The mechanism may include a webbing spaced or continuously disposed between at least pairs of the plurality of conduits along at least a length of the plurality of conduits. The webbing may be frangible to facilitate separation of at least a length of one or more of the plurality of conduits from the set. Alternatively or additionally, the mechanism may include a sheath applied around the plurality of conduits. A portion of the sheath may be removable. The sheath provides a smooth outer surface. Alternatively or additionally, the mechanism may include one or more retainers configured to retain two or more of the plurality of conduits in a group. The retainer may be slidable along the length of one or more of the plurality of conduits.

In some embodiments, the first inspiratory conduit may be configured to deliver respiratory gases including an anesthetic to the patient. The expiratory catheter may be configured to return exhaled gases from the patient to the respiratory support system. The second inspiratory conduit may be configured to deliver respiratory gas to the patient at a flow rate between 20 L/min and 90 L/min.

In some embodiments, the multi-lumen assembly may include or cooperate with a flow switching mechanism operable to direct the flow of respiratory gas into the first inspiratory conduit or into the second inspiratory conduit. . The flow switching mechanism may be a flow diverter. The flow switching mechanism may be user-operable. Alternatively or additionally, the flow switching mechanism may be operably linked with the respiratory support system controller. In some embodiments, the respiratory support system controller controls the respiratory support system to deliver respiratory gas to the multi-lumen assembly based on user operation of the flow switching mechanism. The respiratory support system controller may control the operation of the flow switching mechanism.

In some embodiments, the outflow end of the first inspiratory conduit and the inflow end of the expiratory conduit form a common gas flow path formed by a single gas exchange conduit coupleable with the first patient interface. limited. A taper may be provided to reduce the overall cross-section of the multi-lumen assembly in the area of a single gas exchange conduit.

In some embodiments, the multi-lumen assembly includes a patient end connector for: (a) coupling the outflow end of the first suction conduit to the first patient interface; and (b) coupling the second suction conduit The outflow end is connected to the second patient interface. The patient end connector may include a switching element operable to switch the connector between a first mode of operation and a second mode of operation in which the connector directs breathing gas to the first patient An interface, the connector directs respiratory gases to a second patient interface in said second operating mode. The switching element can be operably coupled with the respiratory support system controller. Alternatively or additionally, the switching element may be user-operable and the controller controls operation of the respiratory support system in response to user operation of the switching element. In some embodiments, a respiratory support system controller controls the operation of the switching element.

In some embodiments, a multi-lumen assembly may include a gas sampling conduit for monitoring one or more properties of the gas. These characteristics may be used by the respiratory support system controller to determine whether the connector is in the first inspiratory conduit or the second inspiratory conduit to deliver respiratory gases to the patient, and the controller may operate the respiratory support system to automatically select a breath Support the corresponding operating mode of the system.

Viewed from yet another aspect, the present disclosure provides a respiratory gas connector for use with a respiratory support system delivering respiratory gas to a patient, the connector having: (a) an inlet port , the inlet port can be connected to a gas flow conduit, the gas flow conduit receives respiratory gas from the respiratory support system; (b) a first outlet port, the first outlet port can be connected to a first gas flow path, so The first gas flow path delivers respiratory gas to the patient through the first patient interface; (c) a second outlet port, the second outlet port can be coupled with a second gas flow path, the second gas flow path passes through the first two patient interfaces for delivering respiratory gases to the patient; and (d) a switching mechanism operable to switch the connector between a first operating mode and a second operating mode in which the connector Gas is directed from the inlet port to the first outlet port, and the connector directs gas from the inlet port to the second outlet port in the second mode of operation.

In some embodiments, the connector may include an expiratory gas port coupleable with the expiratory gas conduit, wherein in the first mode the switching mechanism directs exhaled gas in the first gas flow path to the expiratory gas conduit.

The switching mechanism may be operably coupled with a controller of the respiratory support system, wherein operation of the connector switching mechanism is selectable: (a) a first mode of operation causes the controller to operate the respiratory support system in the first mode, in said first mode One mode in which respiratory gas including anesthetic is delivered to a gas flow conduit coupled to the connector; (b) a second mode of operation causes the controller to operate the respiratory support system in a second mode in which the respiratory gas is The predetermined flow rate is delivered to the gas flow conduit coupled to the connector.

In some embodiments, the connector switching mechanism may be operably coupled with a controller of the respiratory support system such that operation of the connector switching mechanism to select the second mode of operation causes the controller to prevent the flow of anesthetic agent in the respiratory gas.

In some embodiments, the connector may include a sensor that detects one or more characteristics of the gas at the first outlet port or the second outlet port, which characteristics are used to determine whether the connector passes through the first patient interface or the second patient interface. The patient interface is coupled to the patient's airway, and the sensors provide input to the respiratory support system's controller, which automatically selects a corresponding operating mode of the respiratory support system. One or more characteristics include, for example, gas pressure, _CO2 concentration, and gas flow rate.

In some embodiments, the sensor wires may be locatable within a conduit that provides a gas flow path between the sensor and the respiratory support system controller.

Viewed from yet another aspect, the present disclosure provides a controller for use with a respiratory support system delivering respiratory gases to a patient via a multi-lumen assembly, the controller comprising: (a ) a control interface operable to receive a selection by a user of a first operating mode or a second operating mode of the respiratory support system; (b) a tube assembly input connector for interfacing with a first inspiratory conduit, a second patient end couplings of the multi-lumen assembly of the inspiratory and expiratory conduits; (c) a first flow port connectable to a first flow path for delivering respiratory gas to the patient in a first mode; and (d) ) a second flow port connectable to a second flow path for delivering respiratory gas to the patient in the second mode.

In some embodiments, the controller may include a switching mechanism configured to direct breathing gas from the first inspiratory conduit to the first flow port when the first mode is selected and to direct breathing gases from the first inspiratory conduit to the first flow port when the second mode is selected. Gas is directed from the second suction conduit to the second flow port.

In some embodiments, the controller may include a third flow port that may be coupled to the expiratory flow path that receives exhaled gas from the patient in the second mode. The switching mechanism may be configured to direct exhaled gases to the third flow port when the second mode is selected.

In some embodiments, the controller may include mounting means configured to releasably attach the controller to a structure in close proximity to the patient.

In some embodiments, the control interface may be operably linked with the respiratory support system controller. The respiratory support system controller may control the respiratory support system to deliver respiratory gas to the multi-lumen as described above based on the operating mode selected using the control interface. In some embodiments, the respiratory support system controller is operable to control operation of the control interface. The controller may be provided for use with a multi-lumen assembly as described above.

Viewed from yet another aspect, the present disclosure provides a system for delivering respiratory gas to a patient, the system operable to deliver respiratory gas through a first patient interface in a first mode and through a second mode The second patient interface delivers respiratory gases, the system including: ₍ a) one or more _CO2 sensors configured to detect _CO2 in exhaled gas from the patient; (b) a switching mechanism for switching between the first mode and the second mode according to the detected _CO2 ; and (c) a system controller, the system controller receiving signals from the one or more _CO2 Sensor input; wherein the system controller operates the switching mechanism to select the first mode or the second mode.

In some embodiments, the switching mechanism is operable to switch modes when at least a predetermined threshold of _CO2 is detected. This threshold may, for example, be approximately equal to the _CO2 concentration of the ambient air.

The one or more switching mechanisms include one or more mechanical, electronic, electromechanical and pneumatic switching mechanisms. One or more switching mechanisms may be connectable to the system controller via wired connections and/or wireless connections.

In some embodiments, in the first mode, respiratory gases are delivered to the patient's airway through a first patient interface, which may be a sealing interface, such as a sealing mask or an endotracheal tube, and exhaled gases are delivered through The exhaled gas flow path returns to the system. The first mode may include a rebreathing mode in which exhaled gases returned to the system are recirculated for delivery to the patient via the first patient interface. The breathing gas may include one or more anesthetic agents. In some embodiments, the CO ₂ sensor detects CO ₂ in the exhaled gas in the exhaled gas flow path.

In some embodiments, the second mode is a high flow mode in which breathing gas is delivered to the patient at a predetermined flow rate through a second patient interface, which is a non-sealed interface, such as a nasal cannula. The CO ₂ sensor may detect CO ₂ in the exhaled air at the second patient interface as the exhaled air leaves the patient's airway. In some embodiments, a _CO2 sensor may be located on the nasal cannula to detect _CO2 in exhaled air leaving one or both nostrils of the patient.

In some embodiments, the system includes a first breathing device that delivers breathing gas in a first mode and a second breathing device that delivers breathing gas in a second mode. When the second mode is selected, the system may isolate the flow of respiratory gas from the first respiratory device to the patient. In some embodiments, the first respiratory device and the second respiratory device may be integrated into an all-in-one machine, although this need not be the case. In some embodiments, the system may include a humidifier configured to condition the respiratory gas to a predetermined temperature and/or humidity before the respiratory gas is delivered to the patient in the second mode.

In some embodiments, the second respiratory device delivers respiratory gas at a predetermined flow rate, and optionally, by operating the switching device, the predetermined flow rate may be selectable from an available range of about 20 L/min to about 90 L/min.

In some embodiments, the system includes a _CO2 sensor associated with one or each of a first breathing circuit and a second breathing circuit for delivering in the first _mode Breathing gas, the second breathing circuit is used to deliver breathing gas in a second mode. The controller may determine the breathing circuit containing the highest concentration of _CO2 as the breathing circuit through which breathing gas is delivered to the patient, and control the delivery of gas to the determined breathing circuit according to the associated operating mode.

In some embodiments, the system includes a display device in operative communication with the system controller and configurable to display one or more CO2 sensors based on input received by the system controller from the one or more _CO2 sensors. C, CO ₂ , O ₂ traces. The system controller may be configured to automatically cause display _of a single _CO2 trace corresponding to the _CO2 sensor input representing the highest detected value of _CO2 from the plurality of _CO2 sensors.

In some embodiments, the first respiratory device may include one or more of the following: a _CO2 absorber configured to treat returning exhaled gas before the exhaled gas is recycled to the patient in the first mode ; a pressure limiting valve configured to maintain a substantially stable pressure in the system in the first mode; a variable volume used to displace gas in the first mode; a fresh gas flow used to replenish the gas in the first mode anesthetic gas delivered to the patient in the first mode; and a vaporizer for vaporizing the volatile anesthetic agent into the respiratory gas delivered to the patient in the first mode.

In some embodiments, the second respiratory device may include one or more of: a flow source configured to generate a flow of gas through the system; and a humidifier configured to cause the respiratory gas to flow through the system. In the second mode, the respiratory gas is adjusted to a predetermined temperature and/or humidity before delivery to the patient.

Viewed from yet another aspect, the present disclosure provides a system for delivering respiratory gas to a patient, the system comprising: (a) a flow source configured to provide flow through the gas delivery circuit; gas flow of the system; and (b) a gas delivery conduit circuit including an inspiratory gas flow path and an expiratory gas flow path, the system being configured between a first mode and a second mode. switch. In a first mode, the system is operable to deliver respiratory gas to the patient via the inspiratory gas flow path and a first patient interface in fluid communication with the inspiratory gas flow path, and to deliver respiratory gas to the patient via the expiratory gas flow path and with the expiratory gas flow path. A second patient interface in fluid communication with the gas flow path delivers respiratory gas from the patient, the respiratory gas including the first flow parameter. In the second mode, the system is operable to deliver respiratory gas to the patient via the inspiratory gas flow path and the third patient interface, the respiratory gas including the second flow parameter.

In some embodiments, the first flow parameter is different than the second flow parameter. The first flow parameter may include a first flow rate, and the second flow parameter may include a second flow rate, wherein the first flow rate is less than the second flow rate. In some embodiments, the first flow rate is less than 15 L/min and the second flow rate is greater than 15 L/min. In some embodiments, the second flow rate is in a range between about 20 L/min and about 90 L/min, optionally in a range between about 40 L/min and about 70 L/min.

The first patient interface may include a non-sealed patient interface, such as a nasal cannula, and the second patient interface may include a sealed patient interface, such as a mask. The third patient interface may include a non-sealed patient interface, such as a nasal cannula. In some embodiments, the first patient interface and the third patient interface are the same.

In some embodiments, the expiratory flow path is inoperable in the second mode.

In some embodiments, the system is in the first mode when the first patient interface and the second patient interface are applied to the patient simultaneously, and the system is in the second mode when only the third patient interface is applied to the patient. . The first patient interface and the third patient interface may include non-sealing nasal cannulas, and the second patient interface may include a sealing mask, and the system may be in the first mode when the nasal cannula and mask are applied to the patient, and when The system may be in the second mode when only the nasal cannula is applied to the patient. In some embodiments, the mask is configured to seal over the nasal cannula and to the patient.

In some embodiments, the system includes a third mode and a fourth patient interface, and the system can be configured to deliver respiratory gas to the patient via the inspiratory gas flow path and the fourth patient interface, and to deliver respiratory gas to the patient via the expiratory gas flow path and the fourth patient interface. A four-patient interface delivers expiratory gases from the patient. The breathing gas may include a third flow parameter. The fourth patient interface may include a sealed patient interface, such as an invasive patient interface, a laryngeal mask airway, or an endotracheal tube.

In some embodiments, the first flow parameter includes pressure and/or volume parameters.

In some embodiments, the third flow parameter includes one or more of flow, pressure, or volume parameters.

In some embodiments, the system may be configured to control respiratory gas delivery to the patient based on pressure and/or volume.

In some embodiments, the system includes an inspiratory conduit that defines at least a portion of the inspiratory gas flow path and an expiratory conduit that defines at least a portion of the expiratory gas flow path to the patient and a common connector. , the common connector is provided at the ends of the inspiratory conduit and the expiratory conduit, the common connector is configured to connect to one or more patient interfaces.

In some embodiments, the system includes a controller in communication with the flow source and one or more sensors or input interfaces in communication with the controller to provide input to the controller to control the flow source to operate in the first mode or provide respiratory gas flow in a second mode. The sensor and/or input interface may be configured to provide input to the controller to control the flow source to provide a flow of respiratory gas in the third mode.

In some embodiments, the system includes a humidifier, wherein the respiratory gas is heated and humidified by the humidifier in the second mode before the respiratory gas is delivered to the patient.

In some embodiments, exhaled gas from the patient is returned to the inspiratory gas flow path in the first mode. In some embodiments, exhaled gas from the patient is returned to the inspiratory gas flow path in the third mode. In some embodiments _, the system includes a CO ₂ remover configured to remove CO ₂ from the exhaled gas before the exhaled gas is returned to the inspiratory gas flow path.

When a high flow system and an anesthesia machine are integrated together, it would be desirable to have a configuration that allows the respiratory gas delivered during high flow respiratory support to be easily and adequately humidified. It would also be desirable for the breathing gas to be humidified in the high flow mode.

Viewed from yet another aspect, the present disclosure provides a respiratory device for delivering respiratory gas to a patient, the respiratory device comprising: a flow source for providing a flow of respiratory gas in an inspiratory flow path. to deliver it to the patient; a mount for coupling with at least one vaporizer for vaporizing one or more volatile anesthetics into the respiratory tract before delivering the respiratory gas to the patient. in the flow of respiratory gas in the gas flow path; and a return path for recirculating exhaled gas received from the patient via the expiratory flow path to the inspiratory flow path; wherein the bracket can be coupled with the humidification component , for adjusting the respiratory gas flow in the inspiratory flow path to a predetermined temperature and/or humidity before the respiratory gas is delivered to the patient.

In some embodiments, operation of the humidification component prevents delivery of one or more volatile anesthetic agents into the respiratory gas flow in the inspiratory flow path. Operation of the humidification component may inhibit operation of at least one evaporator.

In some embodiments, the respiratory device further includes an interlock mechanism to prevent the humidification component and the at least one vaporizer from operating simultaneously. The interlock mechanism may be configured to enable operation of the humidification component or the at least one evaporator when in the unlocked configuration and to disable operation of the humidification component or the at least one evaporator when in the locked configuration.

The humidification component and the at least one evaporator may be configured to cooperate with each other to provide an interlocking mechanism. The humidification component and the at least one evaporator may be mountable on the respiratory device adjacent to each other. For example, the bracket may include a plurality of slots for coupling the humidification component and at least one evaporator in a side-by-side arrangement. The slot may be configured to receive a housing of the humidification component and a housing of the at least one evaporator. The bracket may be configured to receive the housing of the humidification component and the housing of the at least one evaporator in sliding engagement with the slot.

In some embodiments, the humidification component and the at least one evaporator may each include a locking element associated with its housing. The locking element may be configured to engage a corresponding locking element associated with the humidification component and a housing of another of the at least one evaporator to provide an interlocking mechanism. The locking element may comprise at least one locking pin retractable within the housing in the locked configuration and extendable from the housing in the unlocked configuration. The locking element may comprise two or more locking pins, wherein each locking pin is independently retractable within the housing in the locked configuration and extendable from the housing in the unlocked configuration.

In some embodiments, the humidification component and the at least one evaporator include slots associated with their housings, and the at least one locking pin is slidably movable between the slot of the humidification component and the slot of the at least one evaporator, to provide an interlocking mechanism. The at least one locking pin may be positionable within a slot of the humidification component or the at least one evaporator in the locked configuration, and may be positionable within the slot of the other of the humidification component or the at least one evaporator in the unlocked configuration.

In some embodiments, the respiratory device further includes a switching mechanism configured to enable selective operation of the humidification component and the at least one vaporizer. When the switching mechanism is activated to operate the humidification component or the at least one evaporator, operation of the other of the humidification component and the at least one evaporator may be prevented until the switching mechanism is deactivated.

The switching mechanism may include each of the at least one evaporator and the humidifying component operable by a switch, and the switches may be linked together to prevent the humidifying component and the at least one evaporator from operating simultaneously.

In some embodiments, the switching mechanism is coupled with the interlocking mechanism. Upon activation of the switching mechanism to operate the humidification component or the at least one evaporator, the interlock mechanism may enable operation of the humidification component or the at least one evaporator and may inhibit operation of the other of the humidification component or the at least one evaporator.

In some embodiments, the humidification component includes a humidification chamber through which respiratory gas is received and conditioned to a predetermined temperature and/or humidity. The humidification chamber may be configured to couple with the rack. The housing of the humidification chamber may be configured to be slidably received on the bracket. For example, the bracket may include a plurality of slots, and the housing of the humidification chamber may be slidably received into one of the slots.

The rack may include a heating element for heating the liquid in the humidification chamber. The humidification chamber may include conductive plates for conducting heat from the heating elements in the rack. In other embodiments, the humidification chamber includes a heating element for heating liquid in the humidification chamber. The humidification chamber may be configured to be electrically connected to the respiratory device for operation of the humidification chamber.

In some embodiments, the humidification component includes a humidifier having a humidification chamber that can be coupled to a humidification base unit for operation of the humidification chamber. The humidification base unit may be configured to couple with the stand. The housing of the humidification base unit may be configured to be slidably received on the bracket. For example, the bracket may include a plurality of slots, and the housing of the humidification base unit may be slidably received into one of the slots. The humidification base unit may include a heating element for heating the liquid in the humidification chamber.

A humidification chamber as disclosed herein may include an inlet port for receiving a flow of respiratory gas from a respiratory device and an outlet port for delivering a conditioned flow of respiratory gas to a patient. The outlet port may be coupleable to the inspiratory conduit for delivering a regulated flow of respiratory gas to the patient via the patient interface.

In other embodiments, a humidification chamber as disclosed herein may include an inlet port for receiving a flow of breathing gas from a breathing device and a return port for returning a conditioned flow of breathing gas to the breathing device. The return port may be coupleable with the breathing device for returning the conditioned flow of breathing gas.

In some embodiments, the humidification chamber includes a liquid inlet connected to a liquid reservoir for refilling the humidification chamber. The humidification chamber may include a flow control mechanism to control the flow of liquid into the humidification chamber. The humidification chamber may include at least one sensor for detecting the liquid level in the humidification chamber. The humidification chamber may include a float valve for controlling the liquid level in the humidification chamber.

In some embodiments, the humidification component may be coupled to the bracket via an adapter. The adapter may include a first inlet port for receiving a flow of respiratory gas from the respiratory device and a first outlet port for delivering the flow of respiratory gas to the humidification component. The adapter may further include a second inlet port for receiving the conditioned flow of respiratory gas from the humidification component. The adapter may also include a second outlet port for delivering the conditioned flow of respiratory gas from the humidification component to the respiratory device.

In some embodiments, the adapter is configured to electrically connect with the respiratory device for operation of the humidification component. The adapter may include a first power connector to provide electrical connection to the respiratory device. The adapter may also include a second power connector to provide electrical connection to the humidification component.

The respiratory device may be configured to operate in the following operating modes: a first mode in which the respiratory device delivers respiratory gas to the inspiratory flow path and receives return of exhaled gas via the expiratory flow path; and a second mode in which there is no The respiratory device delivers respiratory gas to the inspiratory flow path at a predetermined flow rate with exhaled gas returned from the patient.

In some embodiments, the respiratory device is further configured to detect coupling of the humidification component to the cradle to enable the respiratory device to operate in the second mode. For example, the bracket may include a sensor for detecting coupling of the humidification component. In the second mode, the humidification component may be operable to regulate the flow of respiratory gas in the inspiratory flow path to a predetermined temperature and/or humidity before the respiratory gas is delivered to the patient.

In some embodiments _, the respiratory device further includes a _CO2 absorber configured to process exhaled gas returning from the patient before the exhaled gas is recycled to the patient in the first mode. In the second mode, the _CO2 absorber may be further configured to condition the respiratory gas in the inspiratory flow path to a predetermined temperature and/or humidity before the respiratory gas is delivered to the patient. In a second mode, the _CO2 absorber may be configured both by changing the amount of soda-calcium present in the _CO2 absorber and by changing the amount of _CO2 provided to the soda-calcium present in the _CO2 absorber. One or both of these are used to adjust the breathing gas to a predetermined temperature and/or humidity.

In the first mode, the respiratory device may be operable to deliver respiratory gases to the patient through a first patient interface forming a sealed interface with the patient's airway and to return exhaled gases to the respiratory device via the expiratory flow path. In a first mode, the breathing gas includes one or more anesthetic agents. The first patient interface may be a mask or an endotracheal tube.

In the second mode, the breathing device may be operable to deliver breathing gas to the patient through a second patient interface forming a non-sealing interface with the patient's airway. The second patient interface may be a nasal cannula.

In the second mode, the predetermined flow rate may be in the range of about 20 L/min to about 90 L/min.

In the second mode, the predetermined flow rate may be in the range of about 40 L/min to about 70 L/min.

In some embodiments, the breathing device may be configured in gas flow communication with a gas delivery device that receives a supply of gas including NO, _O2, and air. The gas delivery device may include a gas mixing element and a gas outlet, the gas mixing element being used to mix one or more of NO, _O2 and air as required to deliver the respiratory gas in the first mode and/or the second mode. The gas outlet supplies gas from the gas delivery device to the breathing device.

In some embodiments, the breathing device may be configured in gas flow communication with the flow meter for controlling the flow of gas including one or both of air and _O in the second mode.

In some embodiments, the breathing device may be configured in gas flow communication with one or more of the following: a pressure limiting valve configured to maintain a substantially stable pressure in the breathing device in the first mode; a variable volume for displacing gas in the first mode; a fresh gas flow for supplementing the respiratory gas delivered to the patient in the first mode; and an evaporator for displacing the respiratory gas during the first mode One or more volatile anesthetic agents are evaporated into the respiratory gas stream prior to delivery to the patient.

In yet another aspect, the present disclosure provides a humidification component for use with a respiratory device for delivering respiratory gases to a patient, the respiratory device comprising: a flow source, the flow source using for providing a flow of respiratory gas in an inspiratory flow path for delivery to a patient; a holder for coupling with at least one vaporizer for converting one or more of the respiratory gas prior to delivery to the patient a plurality of volatile anesthetics evaporating into the respiratory gas flow in the inspiratory flow path; and a return path for recycling exhaled gases received from the patient via the expiratory flow path to the inspiratory flow path; wherein, The humidification component may be coupled to the bracket for regulating the flow of respiratory gas in the inspiratory flow path to a predetermined temperature and/or humidity prior to delivery of the respiratory gas to the patient.

In some embodiments, operation of the humidification component prevents delivery of one or more volatile anesthetic agents into the respiratory gas flow in the inspiratory flow path. Operation of the humidification component may inhibit operation of at least one evaporator.

In some embodiments, the humidification component may be coupled with the bracket to provide an interlock mechanism to prevent the humidification component and the at least one evaporator from operating simultaneously. The interlock mechanism may be configured to enable operation of the humidification component or the at least one evaporator when in the unlocked configuration and to disable operation of the humidification component or the at least one evaporator when in the locked configuration.

The humidification component may be coupleable to the bracket for cooperation with at least one evaporator to provide an interlocking mechanism. The humidification component may be mountable on the breathing apparatus adjacent the at least one vaporizer. For example, the bracket may include a plurality of slots for coupling the humidification component and at least one evaporator in a side-by-side arrangement. The slot may be configured to receive a housing of the humidification component and a housing of the at least one evaporator. The bracket may be configured to receive the housing of the humidification component and the housing of the at least one evaporator in sliding engagement with the slot.

In some embodiments, the humidification component includes a housing having a locking element configured to engage a corresponding locking element associated with the housing of the at least one evaporator to provide an interlocking mechanism. The locking element may comprise at least one locking pin retractable within the housing in the locked configuration and extendable from the housing in the unlocked configuration. The locking element may comprise two or more locking pins, wherein each locking pin is independently retractable within the housing in the locked configuration and extendable from the housing in the unlocked configuration.

In some embodiments, the humidification component includes a housing having a slot, and at least one locking pin is slidably movable between the slot of the humidification component and a slot associated with the housing of the at least one evaporator to Interlocking mechanism provided. The at least one locking pin may be positionable in the slot of the humidification component in the locked configuration and may be positionable in the slot of the at least one evaporator in the unlocked configuration.

In some embodiments, the respiratory device further includes a switching mechanism configured to enable selective operation of the humidification component and the at least one vaporizer. When the switching mechanism is activated to operate the humidification component, at least one evaporator may be prevented from operating until the switching mechanism is deactivated.

The switching mechanism may include a humidification component operable by a switch, and the switch may be linked with a switch of the at least one evaporator to prevent the humidification component and the at least one evaporator from operating simultaneously.

The humidification component may further include a switch operable by a user to enable selective operation of the humidifier. For example, the switch may be a manually operated switch, such as a button or a dial, on the housing of the humidification component.

In some embodiments, the switching mechanism is coupled with the interlocking mechanism. The interlock mechanism may enable operation of the humidification component and disable operation of the at least one evaporator when the switching mechanism is activated to operate the humidification component.

In some embodiments, the humidification component includes a humidification chamber through which respiratory gas is received and conditioned to a predetermined temperature and/or humidity. The humidification chamber may be configured to couple with the rack. The housing of the humidification chamber may be configured to be slidably received on the bracket. For example, the bracket may include a plurality of slots, and the housing of the humidification chamber may be slidably received into one of the slots.

The rack may include a heating element for heating the liquid in the humidification chamber. The humidification chamber may include conductive plates for conducting heat from the heating elements in the rack. In other embodiments, the humidification chamber includes a heating element for heating liquid in the humidification chamber. The humidification chamber may be configured to be electrically connected to the respiratory device for operation of the humidification chamber.

In some embodiments, the humidification component includes a humidifier having a humidification chamber that can be coupled to a humidification base unit for operation of the humidification chamber. The humidification base unit may be configured to couple with the stand. The housing of the humidification base unit may be configured to be slidably received on the bracket. For example, the bracket may include a plurality of slots, and the housing of the humidification base unit may be slidably received into one of the slots. The humidification base unit may include a heating element for heating the liquid in the humidification chamber.

A humidification chamber as disclosed herein may include an inlet port for receiving a flow of respiratory gas from a respiratory device and an outlet port for delivering a conditioned flow of respiratory gas to a patient. The outlet port may be coupleable to the inspiratory conduit for delivering a regulated flow of respiratory gas to the patient via the patient interface.

In other embodiments, a humidification chamber as disclosed herein may include an inlet port for receiving a flow of breathing gas from a breathing device and a return port for returning a conditioned flow of breathing gas to the breathing device. The return port may be coupleable with the breathing device for returning the conditioned flow of breathing gas.

In some embodiments, the humidification chamber includes a liquid inlet connected to a liquid reservoir for refilling the humidification chamber. The humidification chamber may include a flow control mechanism to control the flow of liquid into the humidification chamber. The humidification chamber may include at least one sensor for detecting the liquid level in the humidification chamber. The humidification chamber may include a float valve for controlling the liquid level in the humidification chamber.

In some embodiments, the humidification component may be coupled to the bracket via an adapter. The adapter may include a first inlet port for receiving a flow of respiratory gas from the respiratory device and a first outlet port for delivering the flow of respiratory gas to the humidification component. The adapter may further include a second inlet port for receiving the conditioned flow of respiratory gas from the humidification component. The adapter may also include a second outlet port for delivering the conditioned flow of respiratory gas from the humidification component to the patient or respiratory device.

The respiratory device may be configured to operate in the following operating modes: a first mode in which the respiratory device delivers respiratory gas to the inspiratory flow path and receives return of exhaled gas via the expiratory flow path; and a second mode in which there is no The respiratory device delivers respiratory gas to the inspiratory flow path at a predetermined flow rate with exhaled gas returned from the patient.

In some embodiments, the respiratory device is further configured to detect coupling of the humidification component to the cradle to enable the respiratory device to operate in the second mode. For example, the bracket may include a sensor for detecting coupling of the humidification component. In the second mode, the humidification component may be operable to regulate the flow of respiratory gas in the inspiratory flow path to a predetermined temperature and/or humidity before the respiratory gas is delivered to the patient.

In some embodiments, the respiratory device further includes a _CO2 absorber configured to process exhaled gas returning from the patient before the exhaled gas is recycled to the patient _in the first mode. In the second mode, the _CO2 absorber may be further configured to condition the respiratory gas in the inspiratory flow path to a predetermined temperature and/or humidity before the respiratory gas is delivered to the patient. The breathing apparatus may be further configured to enable the CO ₂ absorber to operate in the second mode by changing _the amount of sodium calcium present in the CO ₂ absorber and by changing the CO 2 provided to the sodium calcium present in the CO ₂ absorber The amount of one or both of these to regulate the breathing gas to a predetermined temperature and/or humidity.

In the first mode, the respiratory device may be operable to deliver respiratory gases to the patient through a first patient interface forming a sealed interface with the patient's airway and to return exhaled gases to the respiratory device via the expiratory flow path. In a first mode, the breathing gas includes one or more anesthetic agents. The first patient interface may be a mask or an endotracheal tube.

In the second mode, the breathing device may be operable to deliver breathing gas to the patient through a second patient interface forming a non-sealing interface with the patient's airway. The second patient interface may be a nasal cannula.

In the second mode, the predetermined flow rate may be in the range of about 20 L/min to about 90 L/min.

In the second mode, the predetermined flow rate may be in the range of about 40 L/min to about 70 L/min.

In some embodiments, the breathing device may be configured in gas flow communication with a gas delivery device that receives a supply of gas including NO, _O2, and air. The gas delivery device may include a gas mixing element and a gas outlet, the gas mixing element being used to mix one or more of NO, _O2 and air as required to deliver the respiratory gas in the first mode and/or the second mode. The gas outlet supplies gas from the gas delivery device to the breathing device.

In some embodiments, the breathing device may be configured in gas flow communication with the flow meter for controlling the flow of gas including one or both of air and _O in the second mode.

In some embodiments, the breathing device may be configured in gas flow communication with one or more of the following: a pressure limiting valve configured to maintain a substantially stable pressure in the breathing device in the first mode; a variable volume for displacing gas in the first mode; a fresh gas flow for supplementing the respiratory gas delivered to the patient in the first mode; and an evaporator for displacing the respiratory gas during the first mode One or more volatile anesthetic agents are evaporated into the respiratory gas stream prior to delivery to the patient.

Description of the drawings

The invention will now be described in more detail with reference to the accompanying drawings, in which similar features are designated by similar reference numerals. It is to be understood that the illustrated embodiments are examples only and should not be construed as limiting the scope of the invention as defined in the appended claims.

Figure 1A is a schematic diagram showing components of a prior art anesthesia machine. Figure IB is a schematic diagram of a prior art ventilator 20.

Figure 2 is a schematic diagram of components of a prior art high flow system.

Figure 3 is a schematic diagram illustrating components in a system for delivering respiratory gases to a patient in accordance with an embodiment of the present disclosure.

4A and 4B are schematic diagrams of a gas delivery device for switching gas flow according to embodiments of the present disclosure.

5A and 5B are schematic diagrams of a gas delivery device for switching gas flow, the gas delivery device having a common gas outlet, according to another embodiment of the present disclosure.

6A and 6B are schematic diagrams illustrating a gas delivery device and a second switching element for switching gas flow according to another embodiment of the present disclosure.

7A and 7B are schematic diagrams of a gas diverter for switching gas flow according to another embodiment of the present disclosure.

Figure 8 is a schematic diagram of a switching mechanism between a gas source and first and second respiratory devices, according to another embodiment of the present disclosure.

Figure 9 is a schematic diagram of a switching mechanism including a flow selector according to an embodiment of the present disclosure.

Figure 10 is a schematic diagram of a switching mechanism including a flow selector according to another embodiment of the present disclosure.

Figure 11 is a schematic diagram of a switching mechanism including a flow selector with a pressure control actuator.

Figure 12A is a schematic diagram of a three-way actuator providing coupling of a ventilation bag in a manual first mode or a bellows in a mechanical first mode. Figure 12B is a schematic diagram of a three-way actuator with a pressure controlled actuator.

Figures 13A and 13B are schematic diagrams illustrating how a three-position switch can provide the physical fluid coupling required to provide switching between modes.

Figure 14 is a schematic diagram of a respiratory device 1000 operable to deliver respiratory gases to a patient in three modes including anesthesia ventilation mode, high flow mode and irrigation mode.

Figures 15A and 15B are schematic diagrams of systems for delivering different modes of respiratory support including ventilatory respiratory support, anesthesia respiratory support and high flow respiratory support.

Figures 16A-16E are schematic diagrams illustrating various alternative embodiments for the systems of Figures 15A and 15B.

Figure 17 is a schematic diagram of a modular system for delivering different modes of respiratory support including ventilatory respiratory support, anesthesia respiratory support and high flow respiratory support.

Figure 18A is an illustration of a gas flow switching mechanism according to an embodiment of the present disclosure. FIG. 18B shows a top cross-sectional view of the switching mechanism in the first mode, and FIG. 18C shows a top cross-sectional view of the switching mechanism in the second mode.

19A and 19B illustrate a gas flow switching mechanism according to another embodiment of the present disclosure in a first mode and a second mode, respectively.

Figure 20 is a schematic diagram of a system attached to a multi-lumen assembly for delivering respiratory gases.

Figure 21 is a schematic diagram showing the patient end of a multi-lumen assembly with a connector portion.

22A-22C are schematic diagrams illustrating retention mechanisms according to various embodiments of the present disclosure.

Figures 23A and 23B are schematic diagrams showing an actuator for switching the flow of respiratory gases towards the patient end of the assembly.

Figure 24 is a schematic diagram of a patient-end connector for use with a multi-lumen assembly to selectively control the flow of respiratory gases toward the patient end of the assembly.

Figures 25 and 26 illustrate a patient interface with _CO2 sensing in accordance with embodiments of the present disclosure.

27 and 28 are schematic diagrams showing a piston drive assembly to selectively direct exhaled gases from a patient mask and a nasal cannula to a gas sampling line with the piston in a first position and a second position, respectively.

Figures 29A and 29B are schematic diagrams illustrating the use of a pressure controlled diverter to selectively direct exhaled gas from a patient mask (Figure 29A) and a nasal cannula (Figure 29B) to a gas sampling line.

Figure 30 is a schematic diagram of a three-way switch for selectively directing expiratory gas from a nasal cannula, endotracheal tube, or sealing mask into a gas sampling line.

31-33 illustrate the use of multiple patient interfaces in the delivery of respiratory support in accordance with embodiments of the present disclosure.

Figure 34 is a schematic diagram of a connector that may be used to facilitate interchange of components for delivery of different modes of respiratory support in accordance with an embodiment of the present disclosure.

Figure 35 is a schematic diagram of another connector for use in accordance with embodiments of the present disclosure.

Figure 36 is a schematic diagram of another connector for use with a nasal cannula for delivering different modes of respiratory support, in accordance with an embodiment of the present disclosure.

37A and 37B are schematic diagrams of a connector that is a variation of the connector of FIG. 36 .

Figure 38 is a schematic diagram of a respiratory device for delivering respiratory gases to a patient that may be coupled with at least one vaporizer and humidification component, in accordance with some embodiments of the present disclosure.

Figure 39 is a front view of the respiratory device of Figure 38, depicted as an anesthesia machine including a vaporizer and humidification components coupled with a stand of the anesthesia machine, in accordance with some embodiments of the present disclosure.

Figure 40 is an enlarged view of the bracket of the anesthesia machine shown in Figure 39 with the humidification component removed and a heating element included in the bracket, in accordance with some embodiments of the present disclosure.

41 is a cross-sectional view of a humidification component for use with a respiratory device for delivering respiratory gases to a patient, wherein the humidification component includes a humidification chamber having a heated device electrically connected to the bracket, in accordance with some embodiments of the present disclosure. element, and the humidification chamber returns conditioned respiratory gases to the respiratory equipment.

42 is a cross-sectional view of another humidification component for use with a respiratory device for delivering respiratory gases to a patient, wherein the humidification component includes a humidifier having a humidification chamber and having A humidification base unit with a heating element electrically connected to the stent, and the humidification chamber receives respiratory gases from the respiratory apparatus and delivers conditioned respiratory gases to the patient via the suction conduit.

43 is a cross-sectional view of yet another humidification component for use with a respiratory device for delivering respiratory gases to a patient, wherein the humidification component includes a humidification chamber having a humidification chamber in a bracket, in accordance with some embodiments of the present disclosure. The conductive plate to which the heating element is coupled, and the humidification chamber returns conditioned breathing gases to the breathing apparatus.

44 is a cross-sectional view of yet another humidification component for use with a respiratory device for delivering respiratory gases to a patient, wherein the humidification component includes a humidifier having a humidification chamber and having The humidification base unit heats the element and the humidification chamber returns conditioned breathing gases to the respiratory equipment.

45 is a schematic diagram of an adapter for coupling a humidification component to a respiratory device for delivering respiratory gases to a patient, wherein the adapter may be coupled to a frame of the respiratory device, in accordance with some embodiments of the present disclosure.

46 is a schematic diagram of an evaporator having an interlock mechanism associated with a housing including two locking pins associated with a switch on a dial, in accordance with some embodiments of the present disclosure.

43A-43C are schematic diagrams illustrating the evaporator of FIG. 46 with the locking pin extended (FIG. 47A) and closed with the locking pin retracted (FIG. 47A), in accordance with some embodiments of the present disclosure. Figure 47B) and in the locked state with one locking pin fully retracted into the housing (Figure 47C).

Figure 48 is a schematic diagram illustrating the evaporator of Figure 46 positioned adjacent a humidification component having a switch associated with a housing and a dial, in accordance with some embodiments of the present disclosure. Same interlocking mechanism.

45A-45B are schematic diagrams illustrating an evaporator and humidification component with the interlocking mechanism of FIG. 48 , in which the evaporator opens with the locking pin extended, thereby locking the humidification component, in accordance with some embodiments of the present disclosure. in the closed position (Fig. 49A) and the humidification component opens with the locking pin extended, thereby locking the evaporator in the closed position (Fig. 49B).

50 is a schematic diagram illustrating another interlocking mechanism in accordance with some embodiments of the present disclosure, wherein the evaporator and humidification components include slots in the housing and the locking pin can slide between the slots to lock the evaporator or The humidification component is locked in the closed position.

47A-47B are schematic diagrams showing the interlock mechanism of FIG. 50 with the locking pin slid over to lock the humidification control in the closed position (FIG. 51A) and with the humidification component open and The evaporator control is locked in the off position (Figure 51B).

Figure 52 is a schematic diagram illustrating switching between vaporizer and humidification components in a respiratory device in accordance with some embodiments of the present disclosure.

Figure 53 is a schematic diagram illustrating a mechanical interlock switch for vaporizer and humidification components in a respiratory device, in accordance with some embodiments of the present disclosure.

Figure 54 is a schematic diagram illustrating a fixed flow meter for operating a second mode of a respiratory device, which is a high flow mode, in accordance with some embodiments of the present disclosure.

Figure 55 is a schematic diagram illustrating two variable flow meters for operating a second mode of a respiratory device, which is a high flow mode, in accordance with some embodiments of the present disclosure.

Figure 56 is a schematic diagram illustrating gas flow through a respiratory device in a first mode that is an anesthesia ventilation mode, in accordance with some embodiments of the present disclosure.

Figure 57 is a schematic diagram illustrating gas flow through a breathing device in a second mode that is a high flow mode, in accordance with some embodiments of the present disclosure.

Detailed ways

Embodiments of the invention are discussed herein with reference to the accompanying drawings, which are not drawn to scale and are intended merely to assist in explaining the invention.

Parts of anesthesia machine

1A is a schematic diagram illustrating components of an anesthesia machine 10 that may be configured to receive a gas supply 1060 for delivering respiratory support to a patient 300 via tubing connections known in the art. Gas supply 1060 may include one or more of an anesthetic gas (eg, nitric oxide (NO)), oxygen (O ₂ ), and air supply. The air supply may be ambient air. A flow meter may be incorporated into the gas supply 1060 or placed upstream of the anesthesia machine 10 or incorporated into the anesthesia machine to control the flow of gas through the anesthesia machine. Typically, such flow meters are controlled manually, but can also be precisely controlled by the anesthesia machine's controller.

The breathing circuit delivers gas to the patient 300 and returns exhaled gas to the rebreathing component 140 . Typically, a breathing circuit includes threaded tubing, valves, and one or more patient interfaces for directing gas into the patient's airway and removing exhaled gas. In the schematic diagram of FIG. 1A , the breathing circuit is simplified and is indicated as including, but not limited to, an inspiratory conduit 110 and a first patient interface 120 that guide gases into the airway 310 of the patient 300 and an expiratory collection of exhaled gases. Catheter 130. Accordingly, first patient interface 120 may be a sealed interface, such as a sealed mask or an endotracheal tube, and may be configured to direct exhaled gases from patient 300 to expiratory flow path 130 that returns exhaled gases to Rebreathing component 140 of anesthesia machine 10 . Typically, the inspiratory and expiratory catheters are connected to the patient interface via Y-piece connectors.

One or more vaporizers 150 convert volatile anesthetics (e.g., isoflurane and sevoflurane) from liquid to vapor at precisely controlled concentrations and dosages as requested by the user, typically an anesthesiologist clinician. Introduce these agents into the breathing circuit. Typically, the vaporizer 150 is manually controlled, but may be precisely controlled by the respiratory device's controller. In some embodiments, vaporizer 150 is fed into rebreathing component 140.

Integrated into the anesthesia machine 10 is a ventilation system that ventilates the patient 300 during induction and after administration of the anesthetic agent to achieve sustained anesthesia. Manual ventilation bag 142 is typically used during induction (dashed line within rebreathing component 140) before the patient is intubated and while volatiles are being delivered. The compliance of the ventilation bag 142 enables the patient to inhale and exhale a fixed volume of gas through the sealed first patient interface 120 in the form of a mask. Once intubated, the ventilation mode changes from manual mode to mechanical mode, thereby effectively isolating the manual ventilation bag 142 and associated pressure relief valve 143 from the rebreathing component 140 so that ventilation via the mechanical system (within the rebreathing component 140 dotted line) for ventilation. Typically, this involves a collapsible bellows 145 that controls the tidal volume and timing of breaths delivered to the patient through a sealed first patient interface 120 in the form of an endotracheal tube. The gas provided to the patient can be controlled in pressure, flow or volume. The pressure relief valves 143, 146 provide for the release of excess gas (caused by the fresh gas flow from the vaporizer 150 and the return of exhaled patient gas) from the rebreathing component 140 while preventing ambient air from entering the breathing circuit.

The rebreathing component 140 provides a gas recirculation system in which exhaled gas from the patient is processed as it flows around the circuit and then rebreathed. This provides advantages by reusing oxygen and volatiles present in the patient's exhaled gas stream, thereby reducing cost and the presence of anesthetic agents in the atmosphere. Exhaled gases in the rebreathing component 140 are passed through a _CO2 absorber 141, which may include a carbon canister containing soda-calcium ( _or another CO2 _- absorbing material). Sodacalcium (a mixture of NaOH and Ca(OH) ² ) acts as a _CO2 scrubber to remove _CO2 before the gas in the rebreathing component 140 re-enters the inspiratory conduit 110. Additionally, gas from pressure relief valves 143, 146 is directed via exhaust ports (not shown) to an external scavenger system 144 that filters and collects anesthetic gas from the gas flow.

It should be understood that other features may also be provided as part of the anesthesia machine 10, such as patient monitoring, suction, pressure gauges, regulators, and "pop-off" valves to protect the patient and machine components from Effects of high pressure gases, as known in the art. For simplicity, these features are not included in the examples shown.

Figure IB is a schematic diagram of a ventilator 20 that may be used in an intensive care unit (ICU). Ventilator 20 ventilates the patient with gas from gas supply 1060 and is often actively humidified by humidifier 420 , which is configured to heat and humidify the gas delivered to the patient's airway 310 . The ventilator 20 may support the patient's own breathing or replace the patient's own breathing by delivering breathing gas to the patient that is controlled to replicate "normal" inspiratory and expiratory breathing phases. Mechanical ventilator 184 may include a flow modulator and/or blower and control the pressure, volume, and respiratory rate of respiratory gas delivered through inspiratory conduit 110 and to the patient through sealed first patient interface 120 . Sealing the first patient interface may be invasive (eg, an endotracheal tube or laryngeal mask airway (LMA)) or non-invasive (eg, a sealing mask). Exhaled gas leaves the patient via the first patient interface and expiratory conduit 130 where it is processed, for example, by a filter 182 and released to the atmosphere. In some non-invasive ventilation systems, exhaled gases are exhausted through a ventilation or exhaust port in the patient interface 120 or exhalation conduit, which allows the exhaled gases to be expelled to the atmosphere without returning to the ventilator device 20 .

Components for high flow systems

FIG. 2 is a schematic diagram of components of a high flow system 30 that may be configured to receive from a gas supply 1060 for delivering high flow respiratory support to a patient 300 . The gas supply 1060 may be one or more of an anesthetic gas (eg, nitric oxide (NO)), oxygen (O ₂ ), or an air supply, preferably an O ₂ and/or air supply. The air supply may be ambient air. The high flow system 30 has a flow modulator 250 configured to generate a flow of gas through a humidifier 420 configured to heat and humidify the flow of gas generated by the flow modulator 250 . In some embodiments, flow modulator 250 may include a gas supply 1060 as described below. The humidified high air flow is delivered to the patient 300 through the second suction conduit 210 and the non-sealed second patient interface 220. Typically, this is accomplished by a nasal cannula that directs a high flow of respiratory gases into the patient's airway 310 through one or both nostrils. An optional filter 230 may be provided between the suction conduit 210 and the second patient interface 220 such that components of the breathing circuit upstream of the filter may be reused without being inadvertently captured by the second patient interface 220 Any risk of exhaled gas contamination.

In some configurations, flow modulator 250 is configured to provide gas to a patient through high flow system 30 . In some embodiments, the flow modulator includes a gas generating device, such as a blower, adapted to receive gases from an environment external to the high flow system 30 and drive them through the high flow system 30 . In some configurations, flow modulator 250 may include a source (eg, oxygen or air) available from a hospital gas outlet or wall supply, or one or more containers of compressed air and/or another gas, and adapted to One or more valve arrangements that control the rate at which gas leaves one or more containers. In some configurations, flow modulator 250 may include an oxygen concentrator.

In this specification, "high flow" means, but is not limited to, any gas flow that is higher than the usual/normal flow rate, for example, higher than the normal inspiratory flow rate in a healthy patient, or higher than the context-sensitive flow rate. Some other threshold flow. "High flow" may be provided by a non-sealed respiratory system with substantial leakage (eg, occurring at the entrance to the patient's airway). "High Flow" can also provide humidification to improve patient comfort, compliance and safety. "High flow" may mean any flow of gas having a flow rate above some other threshold flow relevant to the context, e.g. where gas flow is provided to the patient at a flow rate to meet inspiratory requirements, due to a higher flow rate than might otherwise be provided nominal flow rate, so this flow rate may be considered "high flow". Therefore, "high flow" depends on the context, and what constitutes "high flow" depends on many factors, for example, the patient's health, the type of surgery/treatment/support provided, the patient (adult, child, adult child) properties, etc. Those skilled in the art will understand that, in a specific context, what constitutes "high traffic" but without limitation, some indicative values of high traffic may be as follows.

In some configurations, high flow gas is delivered to the patient at a flow rate greater than or equal to about 5 liters per minute or 10 liters per minute (5 LPM or L/min or 10 LPM or L/min).

In some configurations, the high flow gas is delivered to the patient at a flow rate of about 5 LPM, or 10 LPM to about 150 LPM, or about 10 LPM to about 120 LPM, or about 15 LPM to about 95 LPM, or about 20 LPM to about 90 LPM, or about 20 LPM to about 70 LPM, Or about 25LPM to about 85LPM, or about 30LPM to about 80LPM, or about 35LPM to about 75LPM, or about 40LPM to about 70LPM, or about 45LPM to about 65LPM, or about 50LPM to about 60LPM. For example, in accordance with those various embodiments and configurations described herein, the flow rate of gas supplied by embodiments of the disclosed system may include, but is not limited to, at least about 5 LPM, 10 LPM, 15 LPM, 20 LPM, 30 LPM, 40 LPM, 50 LPM, 60 LPM , 70LPM, 80LPM, 90LPM, 100LPM, 110LPM, 120LPM, 130LPM, 140LPM, 150LPM or larger flows, and useful ranges may be selected to be any of these values (e.g., about 20LPM to about 90LPM, about 15LPM to About 70LPM, about 20LPM to about 70LPM, about 40LPM to about 70LPM, about 40LPM to about 80LPM, about 50LPM to 80LPM, about 60LPM to 80LPM, about 70LPM to about 100LPM, about 70LPM to 80LPM). Accordingly, "high flow" or "high flow respiratory support" may mean breathing at a rate of between about 5 LPM or between 10 LPM and about 100 LPM, or between about 15 LPM and about 95 LPM, or between about 20 LPM and about 90 LPM, or in between. Between about 25LPM and about 85LPM, or between about 30LPM and about 80LPM, or between about 35LPM and about 75LPM, or between about 40LPM and about 70LPM, or between about 45LPM and about 65LPM, or between Gas is delivered to the patient at a flow rate between about 50 LPM and about 60 LPM.

In "high flow", the gas delivered will be selected based on the intended use, such as treatment or support. The delivered gas may include a certain percentage of oxygen. In some configurations, the percentage of oxygen in the delivered gas may be about 15% to about 100%, 20% to about 100%, or about 30% to about 100%, or about 40% to about 100%, Or about 50% to about 100%, or about 60% to about 100%, or about 70% to about 100%, or about 80% to about 100%, or about 90% to about 100%, or about 100% or 100%.

For preemies/infants/pediatrics (weight in the range of about 1 kg to about 30 kg), the "high flow" flow rate may be different. The flow rate can be set from about 0.4 LPM/kg to about 8 LPM/kg, with a minimum value of about 0.5 LPM and a maximum value of about 70 LPM. For patients under 2kg, the maximum flow rate can be set to 8LPM.

High flow can be used as a means to promote gas exchange and/or respiratory support by delivering oxygen and/or other gases and by removing _CO2 from the patient's airways. High flow rates can be especially useful before, during or after medical procedures. Other advantages of high airflow may include that high airflow increases pressure in the patient's airways, thereby providing patency support for opening the airways, trachea, lungs/alveoli, and bronchioles. The opening of these structures enhances oxygen supply and helps CO ₂ removal to a certain extent.

The increased pressure also prevents structures such as the throat from blocking the view of the vocal cords during intubation. When humidified, high airflow can also prevent airway dryness, mitigate mucociliary damage and reduce the risk of laryngospasm, as well as reduce the risks associated with airway dryness, such as epistaxis, aspiration (due to epistaxis) and airway Blockage, swelling, and bleeding.

In this specification, the terms "subject" and "patient" are used interchangeably. A subject or patient may refer to a human or animal subject or patient.

In this specification, it is intended that references to a series of numbers disclosed herein (e.g., 1 to 10) also include all rational numbers within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6 , 6.5, 7, 8, 9, and 10) and also to any range of rational numbers within that range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7), and therefore, expressly disclosed thereby All subscopes of all scopes expressly disclosed herein. These are merely examples of specific intentions, and all possible combinations of numerical values between the lowest and highest values enumerated will be considered to be expressly set forth in this application in a similar manner.

Overview

Embodiments of the present disclosure provide systems and devices for integrating different forms of respiratory support into a single system, or providing integrated switching between separate systems or devices, such that it would be desirable to have different forms of respiratory support delivered to the patient. Clinician users can easily use these systems or devices by switching between respiratory supports. Aspects of the present disclosure relate to various systems, devices, devices, switching mechanisms and lumen components and systems including humidification. It will be appreciated by those skilled in the art that various features and advantages described in the context of one aspect have utility in the context of another aspect, and that such combinations are within the scope of and expressly constitute the present disclosure. part of the public.

System switching with gas control

3 is a schematic diagram illustrating components in a system 1000 for delivering respiratory gases to a patient 300. System 1000 includes a first respiratory device 100 that is configured to deliver respiratory gases including one or more anesthetics to a patient, and a second respiratory device 200 that is configured to Breathing gas is delivered to the patient at a predetermined flow rate. The first respiratory device 100 may include one or more components of the anesthesia device 10 (FIG. 1A), and the second respiratory device 200 may include one or more components of the high flow system 30 (FIG. 2). For simplicity, the same numbers are used throughout this disclosure to refer to such components.

The switching device 700 is operable to select a mode of operation of the system 1000 selected from the group consisting of a first mode in which respiratory gas is delivered to the patient by the first respiratory device 100 and a second mode, In the second mode, respiratory gas is delivered to the patient by the second respiratory device 200 at a predetermined flow rate, which for most patients is typically in the range of about 20 LPM to about 90 LPM.

Figure 3 shows the switching device 700 in dashed lines indicating flexibility in the manner in which the switching device 700 is deployed to provide switching between the first mode and the second mode. In some embodiments, the switching device 700 is arranged between the gas supply 1060 and the first and second devices 100, 200, and/or may comprise one or more elements forming part of the first device or the second device, As will be exemplified by reference to the various embodiments described herein. Thus, although the switching device 700 is schematically shown as a box feature in Figure 3, it will be understood that the switching device may be implemented in that the switching device is constituted by or includes one or more switching mechanisms. Switching mechanisms, the one or more switching mechanisms configured to vary the flow of respiratory gas in the system 1000 based on selection of the first mode or the second mode.

The switching mechanism may in turn consist of or include one or more switching elements. Accordingly, the switching device 700 may include a user-operable actuator that enables a user to manually select an operating mode and thereby cause the system components to operate in the selected mode, and/or a sensor-driven automation system. Operating in mode, the sensor-driven automation system operates components in a mode determined by sensors that detect, for example, which of the first patient interface 100 and the second patient interface 200 is coupled to the patient's airway 310 . Various switching elements may be operably coupled to be actuated substantially simultaneously, or actuated in response to other switching elements or actuators, or under the control of a controller, as will be provided without limitation by reference Sexual examples become apparent.

Although various embodiments are disclosed herein that prevent anesthetic agent from being delivered to the patient when the second mode is selected, it should be understood that other methods may be pursued as an alternative to or in addition to the examples shown in the figures. For example, system 1000 may disable the release of anesthetic agent to the patient by turning off the vaporizer or reducing its functionality to an ineffective level. Alternatively or additionally, the system 1000 may disable the delivery of anesthetic agent to the first respiratory device 100 . Alternatively or additionally, the system may deactivate the anesthetic agent in the respiratory gas flow delivered from the first respiratory device 100 by using a neutralizer in the first respiratory device, which neutralizer is used when the system is in the second mode. Becomes activated during operation, rendering any anesthetic that can flow through the system ineffective. Although wasteful, this can be an important safety measure.

When the first mode is selected, the system 1000 directs respiratory gases in a first inspiratory flow path 110 in which the first patient interface 120 directs respiratory gases into the airway 310 of the patient 300 . First patient interface 120 is a sealed interface, such as a sealed mask or an endotracheal tube, and is configured to direct exhaled gases from the patient to expiratory flow path 130 , which returns exhaled gases to first respiratory device 100 . Returned exhaled gas is processed through rebreathing component 140, as shown in Figure 1.

When the second mode is selected, the system 1000 isolates the respiratory gas flow from the first respiratory device 100 , thereby preventing anesthetic gas including NO and vaporized anesthetic agent from being delivered to the patient 300 . Therefore, when the second mode is selected, the system directs the flow of respiratory gases in the second inspiratory flow path 210 in which the second patient interface 220 directs the respiratory gases to the airway of the patient 300 310 and is a non-sealed interface. Typically, the second patient interface is a nasal cannula with one or more nasal prongs that direct gas into one or both nostrils of the patient.

In one embodiment, the switching device 700 includes a switching mechanism between the gas supply 1060 and the first and second breathing devices 100, 200, and includes a gas delivery device that receives gases including NO, _O2, and/or or a gas supply of air, and a flow meter is provided to control the flow of gas through the one or more breathing gas outlets. Preferably, the flow meter controls the flow of respiratory gas through the one or more respiratory gas outlets in response to selection of the first operating mode or the second operating mode. This can be achieved in a number of ways.

In one example shown schematically in Figures 4A and 4B, the gas delivery device 1040 includes a gas mixing element 1042 for mixing NO, _O2 , and air at the concentrations required for operation of the system in the first mode. Mix proportions. A flow meter may be incorporated into the gas supply 1060 or placed upstream of the gas delivery device 1040 or incorporated into the gas delivery device 1040 to control the proportion of gas entering the gas mixing element 1042 . Typically, such a flow meter is manually controlled, such as by a proportional valve with a rotary actuator, but may also be precisely controlled by the controller 1010 of the system 1000. Safety features can be built in to limit the flow and ratio of gases to safe limits, for example, ensuring that the _O to NO ratio does not drop below 0.25.

Flow meter 1090 controls the flow of breathing gas from gas mixing element 1042 . When the first mode is selected (Fig. 4A), the first gas outlet 1044A supplies breathing gas from the gas delivery device 1040 to the first breathing device 100, and when the second mode is selected (Fig. 4B), the second gas outlet 1044B will Breathing gas is supplied from the gas delivery device to the second breathing device 200 . To accomplish this, first switching element 710 can be operably coupled with switching device 700, and first switching element 710 can be operable to allow NO to flow into gas mixing element 1042 when the first mode is selected (FIG. 4A), And when the second mode is selected (Fig. 4B) NO flow into the gas mixing element is prevented. While the switching device 700 selects the first mode for operation, the flow meter 1090 can be operably coupled with the switching device 700 and can limit the flow to a low flow of up to 15 LPM, preferably 10 LPM to 15 LPM, and when the switching device 700 selects When operating in the second mode, the flow meter 1090 can increase the flow rate up to 90 LPM, preferably 40 LPM to 70 LPM. A second switching element 720 operably coupled with the switching device 700 is operable to control the flow of gas from the gas delivery device 1040 to one of the first gas outlet 1044A and the second gas outlet 1044B. When the first mode is selected, breathing gas (including NO) from the gas delivery device 1040 is directed only to the first gas outlet 1044A, as represented by the solid line in Figure 4A. When the second mode is selected, NO-depleted breathing gas from the gas delivery device is directed only to the second gas outlet 1044B, as represented by the solid line in Figure 4B.

In another example shown schematically in FIGS. 5A and 5B , gas delivery device 1040 includes a single common gas outlet (CGO) 1044 that supplies breathing gas from the gas delivery device to a first breathing device of system 1000 100 and a second breathing apparatus 200. A first switching element 710 operably coupled to the switching device 700 is operable to control the input of the common gas outlet 1044 such that when the first mode is selected (Fig. 5A), the common gas outlet receives breathing gas from the gas mixing element , the breathing gas may incorporate NO, air, and O ₂ ; and when the second mode is selected ( FIG. 5B ), a common gas outlet receives breathing gas from the flow meter 1090 . The second switching element 720 coupled with the switching device 700 is operable to control the flow of gas from the CGO 1044 to the first respiratory device 100 or the second respiratory device. When the first mode is selected, breathing gas (including NO) from the gas delivery device 1040 is directed from the gas mixing element to the CGO 1044 and the first breathing device 100, as represented by the solid line in Figure 5A. When the second mode is selected, breathing gas including _O2 (and optionally excluding NO) is directed from flow meter 1090 to CGO 1044 and second breathing device 200, as represented by the solid line in Figure 5B. It will be appreciated that in some embodiments, when the second mode is selected, breathing gases including air and _O2 (and optionally excluding NO) will be directed from flow meter 1090 to CGO 1044 and the second breathing device.

In Figures 4A-5B, first switching element 710 and second switching element 720 are operably coupled such that they are connected to a switching device (eg, a knob or actuator operable by a user or an electronic controller of the system) Operations are performed substantially simultaneously or following operation of the switching device. Alternatively, the switching device 700 may incorporate the first switching element 710 and the second switching element 720 such that they are incorporated into a common mechanical or pneumatic actuator operable by a user to trigger the first switching element 710 or the second switching element 720 . Switching element 710 and second switching element 720 . The first switching element and the second switching element may comprise, for example, one or more gas flow valves or diverter valves.

In the embodiment shown in Figures 4A-5B, the first respiratory device 100 and the second respiratory device 200 may be integrated into an integrated machine. This provides a convenient complete respiratory support system 1000 that provides the ability to deliver anesthesia to the patient in a first mode and further in a second mode. This is supported by high-flow respiratory support, which is beneficial, for example, when preparing to intubate a patient or when weaning a patient from sedation. This arrangement conveniently places together user-controlled features for the second respiratory device 200 to deliver high-flow respiratory support with user-controlled features for the first respiratory device 100 to deliver sedation. The all-in-one machine also simplifies and reduces the number of instruments taking up valuable space in clinical settings.

In some embodiments, the all-in-one machine may include a humidifier (not shown), typically located between the flow meter and the second patient interface 220 that delivers gas from the second respiratory device 200. The humidifier is configured to condition the respiratory gas to a predetermined temperature and/or humidity before the respiratory gas is delivered to the patient in the second mode. This has the advantage of streamlining humidifier setup by integrating the humidifier into the daily routine of setting up the integrated system 1000 .

However, it should be understood that the described switching mechanism may be similarly deployed in a system 1000 in which the first respiratory device 100 and the second respiratory device 200 are separate machines. Advantageously, the switching device 700 as described above provides integrated control of the operation of these machines such that when the first mode is selected a single switching input simultaneously allows the delivery of gas from the first respiratory device 100 to the patient and prevents the delivery of gas from the second respiratory device 100 to the patient. The device 200 delivers gas or vice versa when the second mode is selected.

Advantageously, the embodiment shown in Figures 4A-5B removes the need to provide an additional oxygen supply; both first breathing device 100 and second breathing device 200 receive oxygen from a common supply 1060. Furthermore, this arrangement facilitates switching to both the first breathing device 100 and the second breathing device 200 simultaneously, so that the first breathing device 100 stops delivering gas to the patient 300 when the second mode is selected. This provides improved safety by preventing anesthetic agents, including NO and volatile anesthetic agents evaporated by the first breathing device, from being delivered in the airflow delivered to the second patient interface 220. Additionally, this arrangement does not allow anesthetic agents to enter the environment, thereby preventing caregivers from inhaling them and also reducing waste.

In yet another example schematically shown in Figures 6A and 6B, the gas delivery device 1040 provides a first switching element 710 and a second switching element 720 outside the gas delivery device, said first switching element 710 Controlling the flow of respiratory gas (including anesthetic agent) from the gas delivery device to the first respiratory device 100 , the second switching element 720 controls the flow of respiratory gas through the second respiratory device 200 . As shown by the dash-dotted lines, switching elements 710 and 720 are operatively linked to operate substantially simultaneously when a desired operating mode is selected by switching device 700 . In the first mode shown in Figure 6A, the first switching element 710 is open and the second switching element 720 is closed. This allows gas to flow from the gas supply 1060 to the gas mixing element 1042 and into the gas outlet 1044 supplying the first respiratory device 100 while preventing gas from flowing through the second respiratory device 200 . In a first mode of operation, respiratory gases including anesthetic agent are delivered to the patient through the first patient interface 120 , which also receives exhaled gases from the patient and returns the exhaled gases to the first respiratory device via the exhalation conduit 130 rebreathing component 140.

In the second operating mode shown in Figure 6B, the first switching element 710 is closed and the second switching element 720 is open. This prevents gas from flowing to the gas outlet 1044, which in turn prevents the delivery of respiratory gas including anesthetic agent from the first respiratory device 100 to the patient. At the same time, flow meter 1090 receives oxygen (and optionally air) from gas supply 1060 and increases flow to a predetermined rate of up to 90 LPM, preferably 40 LPM to 70 LPM. The high airflow from the flow meter 1090 is preferably delivered through the humidifier 420 and to the patient 300 via the second patient interface 220 . In this arrangement, the flow meter 1090, together with the preferred humidifier 420, forms a key component of the second respiratory device 200, as shown by the dashed lines surrounding these features. The advantage of providing the second switching element 720 downstream of the flow meter 1090 is that the flow meter does not require time to reach a predetermined high flow rate when the second mode is selected. However, it should be understood that the second switching element 720 may be located upstream of the flow meter 1090 or downstream of the humidifier 420 .

Switching system with manifold

In another example of the system 1000, in which the switching mechanism 700 is located between the gas supply 1060 and the first and second breathing devices 100, 200, a gas diverter receiving a gas supply including an anesthetic gas and a breathing gas includes two switching devices. , the two switching devices are operable to control the flow of gas to the first breathing device and the second breathing device. An example of a gas diverter 800 is shown schematically in Figures 7A and 7B. Gas splitter 800 receives a gas supply including NO, _O2, and/or air. Gas diverter 800 has a first switching element 710 that controls the flow of NO from gas supply 1060 to outlet 820 and a second switching element 720 that controls the flow of breathing gas (i.e., O ₂ ) Flow to exit 822 or 828. In some examples, the breathing gas may include air, and the second switching element is comprised of pairs of elements 720A and 720B that cooperate to direct the flow of O _and air to outlet 822/ 828 and 824/826. As shown by the dashed lines within gas diverter 800 , switching elements 710 and 720A, 720B are operatively linked to operate substantially simultaneously when a desired operating mode is selected by switching device 700 . The first switching element 710 and the second switching element 720 are operatively coupled by physical (eg, pneumatic, magnetic, mechanical) or electronic means such that operation of one switching element occurs substantially simultaneously with operation of the other switching element.

In the first mode shown in Figure 7A, the first switching element 710 (which may be, for example, a flow control valve) opens, allowing NO to flow to the outlet 820. At the same time, second switching elements 720A, 720B (which may be, for example, gas diverters) direct breathing gases (O ₂ and air) to outlets 822 and 824 respectively. In the second mode shown in Figure 7B, the first switching element 710 is closed, thereby preventing NO flow to the outlet 820. At the same time, second switching elements 720A, 720B direct breathing gases ( _O2 and air) to outlets 826 and 828, respectively. Thus, the switching device 700 selects a first mode of operation to provide supply of breathing gas and NO to the first breathing device 100 (typically via a flow meter), while operation in a second mode prevents the supply of gas to the first breathing device. Advantageously, the first switching element 710 prevents the supply of NO to the outside of the gas diverter 800 so that the respiratory gas delivered to the second respiratory device 200 is free of anesthetic agent when the gas diverter is in the second configuration.

Advantageously, the gas splitter manifold 800 is installed between a gas supply 1060 (eg, a gas wall supply in an operating room (or other medical location)) and a gas inlet port of the first respiratory device 100 , said gas inlet port In fluid communication with evaporator 150 (see Figure 1). A gas splitter manifold 800 is also installed between the gas supply 1060 and the gas inlet port of the second breathing device. Activation of the second mode automatically causes the discontinuation of NO supply to the first breathing device 100 and diverts oxygen and air to the second breathing device 200 . Advantageously, the gas diverter 800 can be supplied as a stand-alone component that can be retrofitted to an existing anesthesia machine or can be incorporated into a newly built machine. In some embodiments, during discontinuation of the supply of NO to the first breathing device 100, a small residual flow of _O2 (and optionally air) may be allowed to flow from the gas splitter manifold 800 to the first breathing device. This may be desirable in situations where an existing anesthesia machine that has had the gas diverter 800 retrofitted is configured to sound an alarm when the machine detects that it is not receiving flow and/or pressure from the _O2 or air supply.

Gas diverter as separate piece

Although gas diverter 800 has been described in the context of components of system 1000, it should be understood that gas diverter 800 may be supplied as a stand-alone device for use with a respiratory system, such as for providing a first respiratory system. A system of functions of device 100 (usually an anesthesia machine) and a second respiratory device 200 (delivering high flow respiratory support). Although the gas splitter 800 shown in Figures 7A and 7B provides three inlets, three outlets to the first breathing device 100, and two outlets to the second breathing device 200, it should be understood that The air inlet and outlet can be omitted so that the gas splitter 800 only receives streams of NO and _O2 . Gas splitter 800 includes a manifold between an inlet and an outlet that provides the flow required to deliver gas to first and second breathing devices 100 and 200 in the first and second modes, respectively. path. In some embodiments, the manifold may combine the streams of NO and _O2 such that they are delivered to the first breathing device 100 via a single common gas outlet. Thus, in one embodiment, gas splitter 800 includes a first outlet (combination 820/822), a second outlet 828, and a manifold between the first and second inlets and the first and second outlets, said The manifold provides a first flow path to the first outlet and a second flow path to the second outlet. In this embodiment, the gas delivery device 800 is operable in a first configuration in which the first flow path is open and the second flow path is closed, and in a second configuration in which the second flow path is closed. The flow path is open and the first flow path is closed. In the first configuration (Fig. 7A), the gas delivery device 800 prevents the flow of anesthetic gas to the outlet.

As disclosed in the context shown in Figures 7A and 7B, the gas delivery device 800 includes one or more switching elements in the manifold for creating a first flow path and a second flow path. The one or more switching elements may include a first valve 710 that controls the flow of anesthetic gas (NO) in the manifold such that in the first configuration the first valve 710 opens and directs NO to the first flow path, and in the first configuration In the second configuration (Fig. 7B) the first valve 710 is closed. The switching element may include a second valve 720 that controls the flow of breathing gas ( _O2 ) in the manifold, such that in a first configuration the second valve 720 directs the breathing gas to the first flow path, and in a second configuration Second valve 720 directs breathing gas to the second flow path. Ideally, one or both of the first valve and the second valve are operable to control the flow of gas therethrough. When a third gas, such as room air or high pressure air from flow modulator 250, is delivered through gas delivery device 800, the manifold can combine the breathing gases (air and _O2 ) such that second valve 720 (shown as 720A, 720B) directs the breathing gas to a single outlet 828, which in the second configuration delivers the breathing gas to the second breathing device. Ideally, the second valve is operable to control the _O2 concentration in the breathing gas delivered to the first flow path and the second flow path. This can be accomplished directly by controlling the proportion of _O2 gas flowing through the manifold, or indirectly by controlling the flow rate of _O2 .

In some embodiments, the gas delivery device 800 can operate in a third configuration in which both the first flow path and the second flow path are open and a stopcock or other can be used at the patient end. A blocking mechanism blocks flow through the first patient interface or the second patient interface. A gas mixer (not shown) may also be included for combining the received gases in the proportions required to deliver the desired treatment. The gas delivery device 800 may include a switching device operable by a user to select a configuration for operation of the gas delivery device, which configuration is accomplished by switching elements (eg, valves and gas flow diverters) in the manifold. The switching means may be located, for example, on the gas diverter device 800, on the first breathing device 100 or on the second breathing device 200, or on a patient interface through which the breathing gas is directed into the airway of the patient.

The switching means may be pneumatic, mechanical, electronic, or utilize any other mechanism suitable for triggering the operation of the switching element. In embodiments utilizing electronic switching devices, the gas delivery device 800 is configured for connection to a power source, and the power source may include a battery. Ideally, both primary and battery power are utilized to recharge the battery in the event of a power outage and ensure continued operation of the gas delivery device until the procedure is completed or primary power is restored.

In some embodiments, the switching device is activated in response to a change in state detected by one or more system sensors. These sensors may include one or more of the following: for example, a pressure sensor, a _CO2 sensor, an _O2 sensor, a flow sensor, a gas concentration sensor, or the like, and they are ideally positioned and configured to determine the movement of a gas whether the breathing circuit delivering to the patient's airway is associated with a first patient interface or a second patient interface through which gas (e.g., including an anesthetic) is delivered to the patient's airway by a substantially sealed interface, The anesthetic-depleted gas is delivered to the patient through the second patient interface via the unsealed interface. The switching device may communicate wiredly or wirelessly with one or more switching elements to control operation of the gas delivery device according to a configuration selected by a user.

In some embodiments, the gas delivery device includes an output module (similar to monitor 1094 in Figure 20) that provides one or both of a visual and audible indication of a configuration in which the gas delivery device is operated. . The output module may also present to the user other parameters relevant to the use of the gas delivery device or the entire respiratory system, such as flow rate and gas concentration. For example, operation of the output module may be activated when the switching device is operated by the user to select the second configuration, or the output module may have a button or actuator such that the output module provides available functionality at all relevant times when switched on. Switch on and off with visual and/or audible instructions.

O ₂ switch

In yet another example of system 1000, wherein switching mechanism 700 is positioned between gas source 1060 and first and second respiratory devices 100, 200, the switching mechanism includes a first switching element 710 operable to In a first mode a flow of O ₂ is directed to the first respiratory device 100 and in a second mode a flow of O ₂ is directed to the second respiratory device 200 . Figure 8 provides a schematic diagram illustrating the operation of such a switching mechanism 700 in a first mode. It can be noted that in the first mode, the second switching element 720 is also open and operable, in a preferred embodiment, to allow the first breathing device 100 to be ventilated/re-ventilated manually (147) or automatically (148). Executed in breathing mode. In the embodiment shown in Figure 8, the manual first mode has been selected. The second switching element 720 is responsive to the first switching element 710 . Therefore, when the first switching element 710 is switched to the second mode, O ₂ is directed to the second breathing device 200 (represented by the flow modulator 250 and the humidifier 420), and the second switching element moves to the lowest position 722, The flow from the first device rebreathing component 140 to the patient 300 is thereby blocked. In some embodiments, O ₂ and/or air may be directed to the second breathing device 200 when the first switching element 710 is switched to the second mode. Since operation of the first switching element 710 in the second mode prevents _O2 from flowing into the gas mixing element 1042 of the first breathing device 100, there is also no flow through the first patient interface to the patient 300.

As in the embodiment illustrated in Figures 4A-5B, the arrangement of Figure 8 eliminates the need to provide an additional oxygen supply; both the first breathing device 100 and the second breathing device 200 receive oxygen from a common supply 1060. Furthermore, this arrangement facilitates switching to both the first breathing device 100 and the second breathing device 200 simultaneously, so that the first breathing device 100 stops delivering gas to the patient 300 when the second mode is selected. This arrangement provides improved safety by preventing the delivery of anesthetic agents, including NO and volatile agents evaporated by the vaporizer 150 of the first respiratory device, in the gas flow delivered to the second patient interface 220 . Additionally, this arrangement does not allow anesthetic agents to enter the environment, thereby preventing them from being inhaled by caregivers caring for the patient and also reducing waste.

The embodiment shown in Figures 6A-8 has particular use in a system 1000 in which the first respiratory device 100 and the second respiratory device 200 are separate machines. Ideally, the second breathing device 200 has in each case a humidifier 420 (shown in detail in Figure 8) to adjust the breathing gas to a predetermined temperature before the breathing gas is delivered to the patient in the second mode. and/or humidity. Additionally, and as previously discussed, the first switching element 710 and the second switching element 720 are operably coupled for operation substantially concurrently with or following operation of the switching device 700 , but it should be understood that , in some embodiments, the switching device may incorporate the first switching element and the second switching element such that they are incorporated with a common mechanical or pneumatic actuator operable by a user to trigger first switching element and second switching element. The first switching element 710 and the second switching element 720 may include one or more gas flow valves or diverter valves.

Switch interface/control

In some embodiments, including within the context of the examples that have been described, it would be desirable that the predetermined flow rate of respiratory gas delivered to the patient 300 in the second mode may range from about 20 LPM to about 90 LPM by user operation of the switching device within the selection, but in some cases such as pediatric or neonatal patients, a lower range would be desirable. Preferably, the desired predetermined flow rate is selectable by the user from a plurality of predetermined available flow rates (e.g., 0 LPM, 40 LPM, and 70 LPM), but it is understood that additional and/or different predetermined flow rates may be disclosed herein. selected within the high flow range.

Selection of the desired predetermined flow rate may be achieved by operating the switching device 700, which in some embodiments includes a rate selector in the form of a knob, slide switch, touch screen or other actuator, which rate selector It is provided that the user selects a required scheduled flow rate from a plurality of scheduled flow rates. An example of a rate switching element 730 associated with a rate selector is presented in the schematic diagram of Figure 9, which is similar to Figure 8 but differs in that the flow modulator 250 has been used with two flow modulators 250A, 250B. Instead, the two flow modulators 250A, 250B, operating at, for example, 70 LPM and 40 LPM respectively, are in fluid communication with the rate switching element 730, which also has a "disconnect" Location 732. In some embodiments, the rate switching element 730 may replace the first switching element 710, but in some embodiments it may be desirable to provide the rate switching element 730 in addition to the first switching element 710 to avoid the need for a second switching element when the second switching element 710 is selected. Delay problem of gas flow rising in mode. Preferably, the rate switching element 730 is operatively coupled to the second switching element 720 such that the rate selector delivers flow from the second respiratory device 200 in the second mode (i.e., through the humidifier 420 to the second respiratory device 200 as shown). Operation of the second patient interface) prevents the delivery of respiratory gases from the first respiratory device to the patient.

In some embodiments, rate switching element 730 selects a rate of 0 LPM to operate to allow _O2 to be supplied to the first respiratory device. This is illustrated schematically in Figure 10, where a rate switching element 730 controls the flow of _O2 to the first respiratory device 100 and the second respiratory device 200. Therefore, when the rate switching element 730 is operated to select one of two predetermined flows (e.g. 40 LPM and 70 LPM), there is a flow _{of O2} to the second breathing device, i.e. in the second mode, and when the rate switching When element 730 is operated to select OLPM, flow from the _O2 supply is directed to the first respiratory device 100, ie in the first mode. The rate switching element 730 and the second switching element 720 are operatively coupled such that operation of the rate selector in the second mode activates switching the second switching element to the lowest position 722 to close the rebreathing component 140 of the first device to the patient. 300 flow. Since operation of the rate switching element 730 in the second mode prevents _O2 from flowing into the gas mixing element 1042 of the first respiratory device 100, there is no flow to the first patient interface in the second mode.

In another example involving a rate selector, a pressure control actuator is deployed to control flow to the first respiratory device 100 and the second respiratory device 200, as shown schematically in Figure 11. In this arrangement, the pressure control actuator 740 detects the return pressure from the second respiratory device 200 . During operation in the second mode, ie when the rate switching element 730 is operated to select an available non-zero flow rate, the pressure control actuator prevents gas flow to the first breathing device 100 . When the rate switching element 730 is operated to select a flow rate of 0 LPM, the back pressure from the second breathing device 200 increases, triggering the pressure control actuator 740 to direct airflow to the first breathing device 100 .

Three-position bag/vent/HF switch

In some embodiments, the switching device 700 provides further functionality to the system 1000 in that the switching device 700 can provide a user-selectable first manual operating mode or a mechanical first operating mode of the first respiratory device and the system in Operation in Second Mode. In the manual first mode of operation, the first respiratory device 100 deploys the ventilation bag for manual ventilation of the patient 300, such as during intubation, with the medical professional manually squeezing the ventilation bag to control delivery to the patient through the first patient interface. The patient's airway breathes gas over time and tidal volume. In the mechanical first operating mode, the first respiratory device 100 deploys the bellows to provide mechanical ventilation to the patient 300, for example once the patient is sedated, where the bellows controls the tidal volume and timing of inspiration/expiration. In both cases, a pressure relief valve is provided to avoid overpressure in the system in the breathing circuit connected to the patient's airway.

In one embodiment, additional functionality is achieved by including a three-way actuator that provides selection of a manual first mode of operation, a mechanical first mode of operation, or a second mode of operation of the system 1000 . An example is provided in the schematic diagram of Figure 12A, which shows a three-way actuator 750 providing rebreathing component 140 of the first breathing device 100 with ventilation in a manual first mode. Fluid coupling of the bag 142 provides fluid coupling of the rebreathing component 140 with the bellows 145 in a mechanical first mode, and with the second breathing device 200 in a second mode. Ideally, as mentioned above, the first respiratory device and the second respiratory device receive _O2 from a common supply. To prevent the supplemental fresh gas flow (FGF) of anesthetic agent from the vaporizer 150 from contaminating the respiratory gas supplied to the second respiratory device, the pressure control actuator 740 may be positioned to detect back pressure when the system 1000 is operating in the second mode. decreases, this triggers the actuator to turn off the FGF. This is shown schematically in Figure 12B and ensures that _O2 is delivered to the patient's airway via the second breathing device 200 and the second patient interface 220 without anesthetic. Advantageously, as shown in Figures 11 and 12B, the use of a pressure controlled actuator provides a superior solution to the contamination problem through the FGF of the gas delivered in the second mode and avoids damage to the different components located in the system 1000 The physical or functional coupling of separate switching elements is required for operation.

Figures 13A and 13B illustrate how a three-position switch (Figure 13A) can provide switching between a manual first operating mode (POS I), a mechanical first operating mode (POS II) and a second operating mode (POS III). Schematic diagram of the required physical fluid connections. Figure 13B schematically shows a breathing circuit including a patient interface connected in each mode.

It will be appreciated that although the embodiment shown in Figures 13A and 13B provides physical three-position switching, an electronic three-position switch may be used to undergo similar control. The electronic three-position switch may communicate with the controller 1010 to control operation of the first breathing device 100 in a manual first mode or a manual second mode, or to switch to a second operating mode in which gas is breathed. delivered by the second respiratory device 200. This type of electronic switch may enjoy wired or wireless communications, the latter providing flexibility in the location of the electronic actuator, which may include one or more of a button panel or touch screen attached to the housing. The housing is removably positioned and ideally mountable in multiple locations, such as the patient's bed, the anesthetist's person, or hardware delivering gas to the patient.

An electronic enable switch may be physically attachable to one or both of the first patient interface 120 or the second patient interface 220 such that when the patient interface is swapped, for example, when changing from pre-cannulation to cannulation, Or the ability to quickly switch the system's operating mode when taking a patient out of sedation. Accordingly, a button or electronic switch located on the patient interface may be activated, causing the system 1000 to select a mode of operation that safely delivers gas to the patient through the interface. Alternatively, you can utilize a foot pedal or foot switch or voice control. Each of the foot pedals or foot switches or voice control has the potential to improve the accessibility of mode selection when the anesthetist is away from the controls located on the anesthesia machine.

Changes detected by the machine prompt NHF to be turned on/off

While some embodiments of the system provide mechanical, pneumatic, or other physical control and operational coupling of the switching elements, in some embodiments, the system 1000 includes a controller 1010 that receives input from data sources deployed throughout the system. input from one or more sensors. The sensor detects whether the breathing circuit coupled to the patient's airway is associated with a first patient interface 120 for use with the first breathing device 100 or a second patient interface 220 for use with the second breathing device 200 . Controller 1010 uses this information to operate switching device 700 to select an operating mode. Therefore, when the one or more sensors detect the breathing circuit associated with the first patient interface 120, then the controller 1010 ensures that the system is operating in the first operating mode. Conversely, when the one or more sensors detect the breathing circuit associated with the second patient interface 220, then the controller 1010 ensures that the system is operating in a second operating mode delivering nasal high flow (NHF) respiratory support.

The sensor may comprise a pressure sensor arranged to measure back pressure in one or both of the first respiratory device 100 and the second respiratory device 200 . System 1000 may provide continuous or intermittent flow of respiratory gas through first respiratory device 100 and/or second respiratory device to enable measurement of back pressure in first respiratory device 100 and/or second respiratory device. In some embodiments, this continuous or intermittent flow of respiratory gas includes a smaller flow, pressure and/or volume than the flow of respiratory gas provided to the patient in the first mode and/or the second mode. When the first (sealed) patient interface 120 and the second (non-sealed) patient interface used in the first and second modes, respectively, are coupled to the patient 300, different flow resistance values are associated with the first (sealed) patient interface. 120 is associated with each of the second (non-sealed) patient interfaces. When the measured back pressure indicates that respiratory gas is delivered to the patient through the sealed patient interface that is substantially sealed to the patient, the controller 1010 determines that the breathing circuit is associated with the first patient interface and that at the first time the respiratory gas and anesthetic agent may be delivered to the patient 300 In one mode the system 1000 is operated and exhaled gas is returned to the rebreathing component. Alternatively, when the measured back pressure indicates that respiratory gas is delivered to the patient through the non-sealed patient interface, the controller 1010 determines that the breathing circuit is associated with the second respiratory device, and the respiratory gas excluding the anesthetic is delivered at a predetermined (high flow) flow rate Operating system 1000 into the patient's second mode. In some embodiments, the pressure sensor may be located at or downstream of the flow modulator 250 of the system, but the pressure sensor may be positioned at any convenient location in the gas flow path between the patient's airway and the flow modulator 250 at.

Alternatively _/ additionally, the one or more sensors may include a _CO2 sensor associated with a first breathing circuit and/or a second breathing circuit with the first patient interface 120 In association, the second breathing circuit is associated with a second patient interface 220 . In such embodiments, the controller 1010 determines as a breathing circuit coupled with the patient's airway a breathing circuit in which the exhaled gas from the patient contains a higher concentration of _CO2 than ambient air. If the CO ₂ concentration in both breathing circuits is higher than ambient air, the controller determines the breathing circuit with the higher CO ₂ concentration as the breathing circuit coupled to the patient's airway.

Alternatively/additionally, the sensors may include one or more proximity sensors, e.g., acoustic (including audible and/or ultrasonic), optical (including infrared), radio frequency, pressure (in the inspiratory/expiratory catheter and/or (in the mask cuff), flow, conductivity, resistance, temperature or other sensors to determine which of the breathing circuits is coupled to the patient's airway through the first patient interface or the second patient interface. Such a proximity sensor is explained in further detail in WO2016157105A1, the contents of which are incorporated herein by reference.

Switching device 700 may include one or more actuators operable by a user, such as, but not limited to, one or more of a button, switch, knob, foot switch, or pedal. Alternatively/additionally, switching device 700 may include one or more of an electronic input device, a touch screen, a voice-activated sensor, or the like, as may be operable with an electronic controller of the system, as will be described. The one or more actuators of the switching device may be located at or near the first patient interface 120 or the second patient interface 220 through which the first respiratory device 100 or the second respiratory device 100 passes. Interface 220 delivers respiratory gases to the patient. Positioning one or more of the actuators at or near the patient end of the breathing circuit that delivers gas to the patient's airway provides convenience to clinicians working with the patient throughout the stages of anesthesia. During the stages of anesthesia it is often necessary to switch between the operating mode of the system and the form of respiratory support delivered. Locating an actuator capable of mode selection at the end of the patient would be more convenient and time-saving for the clinician and others nearby. In other arrangements, system 1000 may be configured to detect which of the first patient interface or the second patient interface is attached to the patient, and modify the operating mode accordingly.

It should be understood that the switching device 700 may include one or more switching mechanisms, such as mechanical, electronic, electromechanical, electromagnetic, pneumatic, or any other suitable switching mechanism, to implement the functions disclosed herein. Furthermore, one or more switching mechanisms may be coupled to the switching device via wired and/or wireless connections using techniques readily understood and ascertainable by those skilled in the art. The switching mechanism may include an actuator operable by a user of system 1000 to select a desired operating mode, and may include or consist of any of the described switching mechanisms. In some embodiments, the actuator includes an electronic input device that wirelessly communicates with the controller 1010 of the system 1000 and is movable relative to the patient 300 and/or the first and second respiratory devices 100 , 200 to different locations.

In some embodiments, one or more switching mechanisms are operable to control one or more characteristics of the respiratory gas delivered to the subject, such as, but not limited to, presence of volatiles, flow rate, gas composition, gas concentration, temperature and/or humidity.

For the sake of brevity, certain features of the first respiratory device 100 are not always shown in the drawings. However, it should be understood that in a preferred embodiment, the first breathing device 100 performs the functions of the anesthesia machine 10 and includes one or more of the following: a CO ₂ absorber 141 configured to absorb the exhaled gas exhaled gas returned from prior treatment is recirculated to the patient in the first mode; a pressure limiting valve 146 configured to maintain a substantially stable pressure in the system in the first mode; a variable volume 145 for use in the first mode; a gas replacement in the first mode (e.g., using a bellows or bag ventilator); a fresh gas stream to supplement the anesthetic gas delivered to the patient in the first mode; and a vaporizer 150 to vaporize the volatile anesthetic agent into the breathing gas delivered to the patient in the first mode.

Similarly, for the sake of brevity, certain features of the second respiratory device 200 are not always shown in the figures. However, it should be understood that in preferred embodiments, the second respiratory device 200 delivers high flow respiratory support as described herein and includes one or more of the flow sources 250 or modulators that The device is configured to generate airflow through the system. Typically, a humidifier 420 is also provided that is configured to condition the respiratory gas to a predetermined temperature and/or humidity before the respiratory gas is delivered to the patient in the second mode, but in some cases humidifier 420 may be omitted.

Anesthesia machine with three modes including _O2 flush

Figure 14 is a schematic diagram of a respiratory device 1000 operable to deliver respiratory gas to a patient via an inspiratory gas flow path and, in some modes, to receive exhaled gas via an expiratory gas flow path. Respiratory equipment can operate in multiple modes. In the first mode, the respiratory device delivers respiratory gases including one or more anesthetic agents to the inspiratory gas flow path and receives exhaled breath via the expiratory gas flow path, typically utilizing components of first respiratory device 100 as described herein. Return of gas. In the second mode, the respiratory device inhibits the flow of one or more anesthetic agents and delivers respiratory gas including _O2 to the inspiratory gas flow path at a predetermined flow rate, typically utilizing components of the second respiratory device 200 as described herein. , without returning exhaled air. In transient mode, the breathing device inhibits the flow of one or more anesthetic agents and delivers high concentrations of _O2 to the inspiratory gas flow path.

The respiratory device includes switching means operable to select an operating mode from a plurality of modes. The switching means may comprise one or more actuators, for example buttons, switches, knobs, foot switches or pedals, indicated in Figure 14 as switching elements 710, 720, which are operable The ground is coupled to deliver breathing gas in either the first mode or the second mode in a manner similar to that described in the context of that illustrated in Figures 4A and 4B. In a first mode, the respiratory device is operable to deliver respiratory gases including an anesthetic to the patient through a first patient interface that forms a sealed interface with the patient's airway, and to deliver exhaled gases through an expiratory gas flow path as described herein. Return to respiratory equipment. Preferably, the respiratory device includes a first respiratory device 100 having the features of Figure 1A corresponding to an anesthesia machine, and the first patient interface is a sealing mask or an endotracheal tube.

In the second mode, the respiratory device is operable to deliver respiratory gases to the patient through a second patient interface (eg, a nasal cannula) that forms an unsealed interface with the patient's airway. It can be noted that in the first mode, anesthetic-containing FGF from the NO source and/or vaporizer 150 enters the inspiratory gas flow path to supplement the patient's sedation. However, in the second mode and the transient mode, the flow of FGF to the second patient interface is inhibited by switching element 720, preventing the release of anesthetic agents into the environment via the unsealed interface, thereby preventing caregivers caring for the patient from inhaling these agents. It also reduces waste. In some configurations, the suction flow path is the same in the second mode and the transient mode. In some configurations, the suction flow path is the same in the first and third modes.

In a preferred embodiment, the transient mode is only activated during normally biased actuator operation. For example, the switching device may include a button or trigger configured to be activated by a user while pressing the trigger or button to operate the respiratory device in a transient mode, and wherein release of the button or trigger disables transient mode. Operation of the button or trigger may open the flush valve 730, which allows a high flow of _O2 to flow through the system bypassing the gas mixing element 1042 and flow meter 1090. Transient mode can be used, for example, to flush the breathing device with _O2 during setup or after use. Ideally, the user can select a transient mode to flush the respiratory device including the first respiratory device and/or the second respiratory device. This may include flushing the first respiratory device 100 in a manual mode of operation in which the bag ventilation components are flushed, or in a mechanical mode of operation in which the mechanical bellows system components are flushed. This will require manual connection of the ventilation bag for some machines, but usually this is always connected to a manual (bag) or mechanical (bellows) ventilation mode that can be controlled by the user Selection is made by operating a switch that changes the gas flow path to the selected vent component.

For operation of the respiratory device in the second mode, it is desirable for the device to be configured in gas flow communication with a flow modulator configured to provide a predetermined flow rate consistent with high flow respiratory support and a humidifier. By airflow through the system, the humidifier is configured to condition the respiratory gas to a predetermined temperature and/or humidity before the respiratory gas is delivered to the patient in the second mode. Such features are represented in FIG. 14 by a second respiratory device 200 having the features of FIG. 2 together with an optional filter 230 . However, it should be understood that humidification can be provided to a limited extent by reconfiguring the _CO2 absorber in the first breathing device, if this can also be configured for high flow support. In this context, it should be noted that although Figure 14 shows two gas outlets 1044A, 1044B, a common gas outlet may supply an all-in-one machine that provides respiratory support in the first and second modes And can also be configured to provide a transient mode that flushes the system with _O2 . This arrangement provides for the use of a common gas source to operate the respiratory device in three modes, eliminating the need to set up an additional oxygen supply to deliver high-flow respiratory support and achieve _O2 flushing.

Blower driven anesthesia machine with high flow mode

Another aspect of the present disclosure provides a system for delivering respiratory gases to a patient that is capable of delivering different modes of respiratory support including ventilation, anesthesia, and, in some embodiments, High flow respiratory support. Figures 15A and 15B are schematic diagrams of a system 1300 having a flow generator 1350 adapted to receive fresh air and gases 1310 from the environment and drive the fresh air and gases 1310 through the system to provide The airway 310 of the patient 300 is delivered through the suction catheter 110 coupled to the sealed first patient interface 120 . A switch actuator, such as a button, switch, knob, footswitch or pedal, or an electronic interface in operative communication with a system controller may be operated by a user to select a mode of operation of system 1300, wherein in a first mode (FIG. 15A ) and in a second mode (Fig. 15B) delivering respiratory gas in a closed gas flow circuit in which exhaled gas is returned to the system through exhalation conduit 130 for patient rebreathing, In the second mode, breathing gas is delivered in an open gas flow circuit without further breathing.

Ideally, flow generator 1350 is a blower with variable control that can be selected by the user or system controller. Desirably, the switching actuator includes or is operably coupled with a switching mechanism 1370 that controls the flow of fresh gas into the system 1300 based on the operating mode selected using the switching actuator. In the first mode (Fig. 15A), the switching mechanism 1370 prevents the first flow of fresh breathing gas to the system and allows exhaled gas to return to the system, while in the second mode, the switching mechanism allows the first flow of fresh breathing gas flows into the system and prevents exhaled air from returning to the system. In some embodiments, switching mechanism 1370 is a flow diverter, and in some arrangements may be a pressure-controlled flow diverter, configured to detect back pressure in system 1300 and when high back pressure is detected, at One mode of operation signals that a sealed patient interface that returns exhaled gases to the system has been applied to the patient 300 .

Typically, switching mechanism 1370 is located upstream of flow generator 1350, as shown in Figures 15A and 15B. Switching mechanism 1370 is operably coupled to flow generator 1350 such that selection of a first mode of operation of the switching actuator causes the flow generator to operate at a low flow, such as less than 15 LPM, and selection of a second mode causes the flow generator to ventilate the patient. Compatible with higher flow operation, and the third mode selection enables the flow generator to operate at high flow rates up to 90LPM.

In some embodiments, operation of system 1300 in the first mode is capable of delivering anesthesia. In such embodiments, the system 1300 also receives an oxygen supply from an O _source 1060 and a vaporized volatile anesthetic, such as sevoflurane, from the vaporizer 150 . These gases are mixed by gas mixer 1042 in the desired proportions and concentrations (as determined by the user or the system's controller). The mixed gas is delivered to the patient via the suction conduit 110 and seals the first patient interface 120 into the patient's airway 310 . Exhaled gases are returned from the first patient interface 120 to the expiratory conduit 130 and system 1300, where _CO2 is removed by the _CO2 absorber 141 and the gas is recycled back to the inspiratory path.

In some embodiments, operation of system 1300 in the second mode is capable of providing ventilatory support to the patient. This form of support may be delivered by the same first patient interface 120 as in the first mode of operation, except that the switching mechanism 1370 operates to allow fresh air to flow into the system 1300 while preventing gas recirculation. Thus, gases returned by the exhalation conduit 130 may be vented to the environment or a vent, or released through a vent in the patient interface through which respiratory support is delivered. In another form of respiratory support delivered in the second mode, the first patient interface 120 is replaced with a non-sealing patient interface such as a nasal cannula, and the flow generated by the flow generator is increased to deliver high flow such that System 1300 operates in a second mode of delivering high flow respiratory support to patient 300. Thus, operation of switching the actuator to select the second mode causes the flow generator to operate at a flow rate sufficient to deliver high flow respiratory support (eg, up to 90 LPM). In embodiments in which the switching actuator 1370 is a pressure-controlled flow diverter, the system 1300 is consistent with the connection of the second non-sealed patient interface 220 such as a nasal cannula (or the disconnection of the expiratory conduit 130 from the system 1300 ). The low back pressure in the system automatically opens the flow of fresh gas into the system while shutting off gas recirculation. During operation of the system in the second mode, O ₂ may also be provided from an O ₂ source 1060 , wherein the O ₂ concentration is selected by operation of a switching actuator that may be operatively coupled to the O ₂ source or gas mixer 1042 , Or select by manually selecting the _O2 concentration at the supply controller provided at the O2 _source . System 1300 is also configured to prevent anesthetic gas from being supplied to the system when the second mode is selected. This may be accomplished by manually providing the evaporator 150 to be turned off by the user, or by providing an evaporator switching mechanism operatively linked to the switching mechanism 1370 and/or the system controller 1010 .

In some embodiments, the system 1300 includes a pressure relief valve 146 to maintain a substantially stable gas pressure in the system when operating in the first mode, which would otherwise increase as oxygen and oxygen are added to the system 1300 in the first mode. Increased by volatile matter. An expiratory valve 143 or variable flow constriction may be provided to modulate the airflow in the system 1300 to produce expiratory and inspiratory breathing cycles, particularly when this cannot be achieved by modulating the flow through the flow generator 1350 . As shown in FIGS. 15A and 15B , in some embodiments, the system 1300 is configured to connect the inspiratory conduit 110 and the expiratory conduit 130 to the system 1300 downstream of the flow generator 1350 . Vaporizer 150 receives a supply of anesthetic gas. However, this doesn't have to be the case though.

16A-16E are schematic diagrams illustrating various alternative embodiments for system 1300. In Figure 16A, vaporizer 150 is located downstream of flow generator 1350, and switching mechanism 1370 provides a separate gas flow path via a separate inspiratory conduit for delivering high flow respiratory support to the second non-sealed patient interface. An adjustable pressure limiting valve (APL) is configured to release returning gas into the scavenger system (as described with reference to Figure 1). However, it should be understood that in the various disclosed embodiments, the APL may be represented by any form of pressure reducing valve, and the adjustable pressure limiting valve is only one example. In Figure 16B, the evaporator 150 is disposed in the return gas flow path upstream of the _CO2 absorber 141 (although the return gas flow path may be located downstream of the _CO2 absorber 141). In Figure 16C, vaporizer 150 is connected in parallel with flow generator 1350, and ventilation bag 142 provides manual ventilation to the patient. In Figure 16D, vaporizer 150 is connected upstream of flow generator 1350, which receives gas, including anesthetic agent, and drives it to suction conduit 110. In Figure 16E, system 1300 includes a flow reflector 1360 configured to collect anesthetic gas exhaled from the patient and return the anesthetic gas to the inspiratory gas flow path during the subsequent inspiratory phase.

In various embodiments, system 1300 includes a humidifier configured to condition the respiratory gas to a predetermined temperature and/or humidity before the respiratory gas is delivered to the patient in the second mode. Ideally, a humidifier (not shown) is located downstream of the blower before the second patient interface 220 .

Another system for delivering respiratory gases to a patient is shown in the schematic diagram of Figure 17, which system is capable of delivering different modes of respiratory support, including ventilation, anesthesia and, in some embodiments, high flow respiratory support. Here, system 1300 may operate in a first mode including recirculated gas flow between the system and the patient's airway, and a second mode including flow between the system and the patient's breathing airway. non-recirculating gas flow between System 1300 includes a first module 1380 that includes a first set of respiratory components, and a second module 1390 that includes a second set of respiratory components. The second module 1390 is configured to cooperate with the first module 1380 (or vice versa) to switch between the two modes. Thus, the system 1300 can operate in the first mode when the first module 1380 is activated or coupled with the second module 1390, and when the first module is deactivated or disconnected from the second module, the system 1300 can operate in the first mode. Operation in the second mode allows the second module to function independently of the first module.

In some embodiments, during the first mode of operation of system 1300, the gas delivered to patient 300 in the recirculating gas flow includes anesthetic agent delivered by vaporizer 150, which vaporizes the volatile anesthetic agent delivered to in the patient's respiratory air. Accordingly, the first set of respiratory components of the first module 1380 may include one or more of the following: a CO ₂ absorber 141 configured to process return exhaled gas before recycling to the patient in the first mode of exhaled gas; a pressure limiting valve 146 configured to maintain a substantially stable pressure in the system in the first mode; a variable volume for displacing gas in the first mode (e.g., ventilation bag 142 or bellows ). The fresh gas flow from vaporizer 150 supplements the anesthetic gas delivered to the patient in the first mode.

During the second mode of operation, the second module 1390 operates independently of the first module 1380 to deliver, for example, ventilatory support and, in some embodiments, high-flow respiratory support to the patient 300 . Accordingly, the second set of respiratory components of the second module 1390 may include: one or more flow sources, such as a blower 1350, configured to generate a flow of gas through the second set of respiratory components; the suction conduit 110 and the patient interface, The suction conduit 110 and patient interface are configured to direct gas from the non-recirculated gas flow to the patient's airway. When the system 1300 is in the second mode for delivering ventilatory support, the patient interface may be a sealed patient interface in which exhaled gases are returned to the system via the expiratory conduit 130 where the exhaled gases are vented to the atmosphere or Vent (and no longer circulate to patient). Alternatively, exhaled gases may exit the sealed patient interface through a port hole in the interface or exhalation conduit. When the system 1300 is used in the second mode to deliver high flow respiratory support, the patient interface is ideally a non-sealing second patient interface, such as a nasal cannula. A humidifier (not shown) may be provided to condition the respiratory gas to a predetermined temperature and/or humidity before the respiratory gas is delivered to the patient in the second mode; and a filter upstream of the patient interface may be provided to reduce the contamination of the upstream second set of respiratory components so that the second set of respiratory components can be reused.

In some embodiments, the first module 1380 includes a first gas outlet 1388 and a first gas inlet 1386, and the second module 1390 includes a second gas inlet 1396 and a second gas outlet 1398, wherein the first gas outlet may be coupled to the second gas inlet 1396. The gas inlet is coupled, and the first gas inlet can be coupled with the second gas outlet, for operating the system 1300 in the first mode, as shown in Figure 17. Thus, in the first mode of operation, the system utilizes the same patient breathing circuit, including the inspiratory conduit 110 and the expiratory conduit 130, to deliver respiratory gases including anesthetic agent to the patient. A one-way valve 149 may be provided to prevent gas from flowing back into the patient. It will be appreciated that in use, the patient interface may be switched by the user to ensure that gas delivered in a first mode is delivered via a sealed first patient interface (eg, a sealed mask or endotracheal tube), and in a second mode Gas is delivered via a non-sealed secondary patient interface (eg, nasal cannula), or via a sealed patient interface with exhaled gas vented or expelled (ie, not returned to the patient).

It can be noted that due to the coupling between the second gas outlet 1398 and the first gas inlet 1386, operation of the system 1300 in the first mode allows a first flow of fresh breathing gas 1310 to flow to the system, and simultaneously allows the return of exhaled gas to the system. One-way valve 149A may be provided to prevent return gas from flowing back into fresh gas supply 1310. At the same time, due to the disengagement of the second gas outlet 1398 and the first gas inlet 1386, the operation of the system 1300 in the second mode independent of the first module 1380 allows a first flow of fresh breathing gas 1310 to flow into the system and prevents the return of exhaled gas. to the system. Additionally, operation in the second mode prevents the release of anesthetic agent from the system, such as by providing a shut-off valve in the first gas outlet 1388 and/or by closing the vaporizer 150 and/or by providing a bypass around the vaporizer 150 .

Switches set in the breathing circuit

Yet another aspect of the present disclosure relates to switching at the patient end of a breathing circuit that delivers breathing gas to the patient 300 in either a first mode or a second mode. In one embodiment, a system for delivering respiratory gases to a patient includes a flow modulator 250 configured to generate gas flow through the system in a gas delivery circuit, and a switching mechanism. The mechanism forms part of the gas delivery circuit. Figure 18A is a perspective view of a switching mechanism 900 configured to switch between gas flow paths in a gas delivery circuit based on selection of a first operating mode or a second operating mode, in which The inspiratory gas flow path 910 is in fluid communication with the first patient interface 120 and in the second operating mode the inspiratory gas flow path 910 is in fluid communication with the second patient interface 220 .

Typically, the first patient interface 120 forms a substantially sealed interface with the patient's airway and receives exhaled gases from the patient. Thus, in the first mode, the exhalation path 930 returns exhaled gases to the system, specifically to the ventilator or anesthesia machine of the system, where the exhaled gases are processed, such as by filtration, and Released to the atmosphere or recirculated in the anesthesia machine rebreathing system. Typically, the second patient interface 220 forms a non-sealing interface with the patient's airway and is, for example, a nasal cannula, allowing exhaled gases to be released to the environment around the non-sealing nasal prongs of the cannula.

In one embodiment shown in Figure 18A, the switching mechanism 900 includes an "X-piece" connector 950 and an actuator 940 in the form of a rotary switch that is operable by a user to operate in the gas delivery circuit. Switch between gas flow paths. The actuator may take any suitable form, such as a knob, switch, lever or the like. An optional anesthesia reflector 960 is also shown in Figure 18A. 18A is a top cross-sectional view of the switching mechanism 900 of FIG. 18A in a first mode, in which respiratory gases in the inspiratory flow path 910 are directed to the first patient interface 120 and exhaled gases are returned to the switching mechanism through a common conduit. Return to the system via expiratory gas flow path 930. 18C is a top cross-sectional view of the switching mechanism 900 of FIG. 18A in a second mode in which respiratory gases in the inspiratory flow path 910 are directed to the second non-sealed patient interface 220. No gas is returned in this mode.

In some embodiments, the system is configured to receive user input to select a first mode of operation in which the flow source 1350 produces a low flow rate below a predetermined flow rate, or a second mode of operation in which the flow source 1350 generates a low flow rate below a predetermined flow rate. The operating mode is one in which the flow source generates a high flow rate equal to or higher than a predetermined flow rate, and in which the switching mechanism 900 operates in response to the flow rate of gas in the suction gas flow path as generated by the flow source. A bistable switch 948 as shown in Figures 19A and 19B may be used in such embodiments. When the flow through the "X-piece" exceeds a threshold flow, eg 15 LPM or eg corresponding to the delivery of high flow respiratory support, the flow is delivered to the second patient interface 220 (Fig. 19B). Below the threshold flow, flow is delivered to first patient interface 110 and exhaled gas is returned through expiratory flow path 930 (Fig. 19A). However, it should be understood that the switching mechanism may comprise any suitable mechanism, including, but not limited to, one or more of a flow diverter, a pneumatic switch, a rotary switch, a lever, a flap or valve, or the like.

In some embodiments, user-controlled actuator 1440 operates a diverter that controls the flow of respiratory gases toward the patient. An example is shown schematically in Figures 23A and 23B. In some embodiments, actuator 1440 is operably coupled with system 1000 such that a user operates the actuator to switch flow delivery between patient interfaces to cause control of system 1000 to switch to an operating mode that delivers respiratory gas. For example, in Figure 23A, actuator 1440 is in a first position and directs respiratory gases from first inspiratory conduit 1410 to first patient interface 120, which returns exhaled gases via expiratory conduit 1430. This is consistent with the first mode of operation, which provides delivery of respiratory gases including anesthetic agent and return of exhaled gases for treatment by the rebreathing component, as disclosed herein. In Figure 23B, the actuator is in the second position and directs respiratory gases from the inspiratory conduit 1410 to the second patient interface 220, which is a non-sealing interface, such as a nasal cannula. This requires the system controller 1010 to direct breathing gas into the inspiratory conduit 1410 (ie, high flow without anesthetic agent), consistent with the second mode of operation. Exhaled air is exhaled into the environment. This is consistent with the second mode of operation, which provides the delivery of high flow respiratory support as disclosed herein.

In some embodiments, a system utilizing switching mechanism 900 includes one or more sensors configured to monitor one or more characteristics of the gas in the gas delivery circuit and, based on the one or more sensors, Each monitored characteristic controls the operation of flow modulator 250. These properties may indicate one or more of flow, pressure, and _CO2 , for example. The system controls operation of the flow modulator 250 to produce a low flow (eg, less than 15 LPM) when one or more sensors indicate respiratory gas flow to the first patient interface 110, and to produce a low flow rate (eg, less than 15 LPM) when the one or more sensors indicate respiratory gas flow to the first patient interface 110. The second patient interface 220 generates high flow rates using various techniques described herein.

When considering this disclosure as a whole, as those skilled in the art will appreciate, systems utilizing switching mechanism 900 or other switching concepts disclosed herein may include one or more components commonly found in anesthesia machines: for example, CO ₂ absorption a device configured to process returning exhaled gas before the exhaled gas is recycled to the patient in the first mode; a pressure limiting valve configured to maintain a substantially stable pressure in the system in the first mode; a variable volume (e.g., ventilation bag or bellows) for displacing the gas in the first mode; a fresh gas stream for supplementing the anesthetic gas delivered to the patient in the first mode; and a vaporizer for converting the volatilized gas The anesthetic agent evaporates into the breathing gas delivered to the patient in the first mode. Additionally, such a system may include one or more features of a high flow respiratory support system, such as a flow modulator configured to provide a high flow through the system and a humidifier configured to The respiratory gas is adjusted to a predetermined temperature and/or humidity before the respiratory gas is delivered to the patient in the second mode.

Although switching mechanism 900 has been described in the context of a component of system 1000, it should be understood that switching mechanism 900 may be provided as a separate component from such a system. In this sense, the switching mechanism 900 may be considered a respiratory gas connector having an inlet port 911 coupled with a gas flow conduit 910 that receives respiratory gas from the respiratory support system; a first outlet port 921, which can be coupled with a first gas flow path for delivering breathing gas to the patient through the first patient interface 120; a second outlet port 922, which can be coupled with a second gas flow path for delivering breathing gas to the patient through the second patient interface 220. a flow path coupling; and a switching mechanism 940 operable to switch the connector between a first mode of operation and a second mode of operation in which the connector directs gas from the inlet port to the first outlet port , the connector directs gas from the inlet port to the second outlet port in the second mode of operation.

The expiratory gas port 931 may be coupled to the expiratory gas conduit, wherein in the first mode the switching mechanism directs exhaled gas in the first gas flow path to the expiratory gas conduit. The switching mechanism may be operably coupled with the controller 1010 of the respiratory support system, wherein operation of the connector switching mechanism 940 may select the first operating mode or the second operating mode. The first mode of operation causes the controller to operate the respiratory support system in a first mode in which respiratory gas including an anesthetic agent is delivered to the gas flow conduit 910 coupled with the connector. The second mode of operation causes the controller to operate the respiratory support system in a second mode in which respiratory gas is delivered at a predetermined flow rate to the gas flow conduit 910 coupled to the connector. In some embodiments, the connector switching mechanism 940 is operatively coupled with a controller of the respiratory support system such that operation of the connector switching mechanism to select the second mode of operation causes the controller to prevent the flow of anesthetic agent in the breathing gas.

Sensors may be provided to detect one or more characteristics of the gas at the first outlet port 921 or the second outlet port 922, which characteristics are used to determine whether the connector passes through the first (sealed) patient interface 120 or the second (unsealed) ) Patient interface 220 is coupled to the patient's airway, and the sensors provide input to the respiratory support system's controller, which automatically selects a corresponding operating mode of the respiratory support system. The one or more characteristics include, but are not limited to, gas pressure, _CO2 concentration; and gas flow rate. Sensor wires positionable within the catheter provide a gas flow path between the sensor and the respiratory support system controller.

In yet another aspect, a switching mechanism may be provided by using first patient interface 120 and second patient interface 220 simultaneously. Thus, the first mode is selected when the first patient interface and the second patient interface are applied to the patient simultaneously, and the second delivery mode is selected when only the second patient interface is applied to the patient. In one arrangement, the first patient interface is a mask that is capable of sealing over the second patient interface as a nasal cannula without blocking flow through the cannula. Inspiratory airflow is delivered through the cannula, and expiratory airflow is returned through the mask. This arrangement may be deployed to deliver anesthesia in a closed system that utilizes a cannula to deliver the anesthetic to the patient and a mask to return exhaled gases. A pressure sensor may be used to determine when the mask is applied to the patient and seals against the cannula so that when a target pressure is detected at the mask (e.g., within the mask or within the mask cuff), the system in turn begins passage through the nasal cannula Deliver anesthetic to respond. Commonly owned patent publication WO 2015145390 discloses a face mask suitable for use herein and is incorporated herein by reference.

Figures 31-33 illustrate one example of how switching between modes of use of a system for delivering respiratory gases to a patient may be provided by using a first patient interface and a second patient interface simultaneously or separately. The system includes a flow source configured to provide gas flow through the system in a gas delivery circuit having an inspiratory gas flow path 210 and an expiratory gas flow path 130 . In a first mode, the system is operable to deliver respiratory gas to the patient via the inspiratory gas flow path 210 and a first patient interface in fluid communication with the inspiratory flow path, and to deliver respiratory gas to the patient via the expiratory gas flow path 130 and with the expiratory gas. A second patient interface in fluid communication with the flow path delivers respiratory gas from the patient, the respiratory gas including the first flow parameter. In the second mode, the system is operable to deliver respiratory gas to the patient via the inspiratory gas flow path 210 and the third patient interface, the respiratory gas including the second flow parameter. The first flow parameter and the second flow parameter include or correspond to the first flow rate and the second flow rate, respectively. In some embodiments, the first flow rate is less than 15 L/min and the second flow rate is greater than 15 L/min. In some embodiments, the second flow rate ranges between about 20 L/min and about 90 L/min, optionally between about 40 L/min and about 70 L/min. However, it should be understood that the first flow parameter may alternatively or additionally include pressure and/or volume parameters.

As shown in Figure 31, the first patient interface is a non-sealed patient interface, as shown by nasal cannula 224, which is in fluid communication with the inspiratory gas flow path 210, and the second patient interface is a sealed patient interface (eg, Mask 124 shown). In Figure 32, nasal cannula 224 and mask 124 are applied to the patient simultaneously such that the system is operable with the mask 124 and the patient in a first mode of providing anesthetic ventilation, the mask 124 being configured to seal against the nasal cannula. 224 above. In this arrangement, respiratory gases are delivered to the patient via an inspiratory conduit and nasal cannula 224 that provide an inspiratory gas flow path 210 , and exhaled gases from the patient are delivered from the patient via a mask 124 and an expiratory conduit that provides an expiratory gas flow path 130 Patient transport. In Figure 31, in a second mode of providing high flow respiratory support, only the nasal cannula 224 is applied to the patient for delivering respiratory gases to the patient's airway. In Figure 31, the first and third patient interfaces are the same and are nasal cannula 224. In some embodiments, exhalation flow path 130 is not required or is inoperable in the second mode. In an alternative embodiment, breathing gases are delivered to the patient via gas flow path 130 and mask 124 , and exhaled gases are delivered from the patient via nasal cannula and gas flow path 210 . In such embodiments, gas flow path 130 is an inspiratory gas flow path and gas flow path 210 is an expiratory gas flow path. In some embodiments, exhaled gas is returned to the system.

Figure 33 provides an arrangement for operating the system in the third mode. In the third mode, anesthetic ventilation is delivered through the endotracheal tube 126 . Here, the inspiratory conduit providing inspiratory gas flow path 210 has been detached from nasal cannula 224 and coupled with the inlet of coupler 600 . Similarly, the expiratory conduit providing expiratory gas flow path 130 has been detached from mask 124 and coupled with the outlet of coupler 600 . The patient end of coupler 600 has been connected to a fourth patient interface, shown as endotracheal tube 126 . In some embodiments, endotracheal tube 126 may be a laryngeal mask or a tracheostomy interface. In the third mode, respiratory gas may be delivered to the patient, the respiratory gas including a third flow parameter, which may include one or more of flow, pressure, or volume parameters.

An advantage of mode switching according to the example described with reference to Figures 31 to 33 is that a single inspiratory conduit and a single expiratory conduit can be used to provide the patient with several modes of respiratory support. This reduces the cost and complexity of the breathing circuit used to treat patients.

Figure 34 is a schematic diagram of a novel connector 1700 that can be used to facilitate the interchange of components used to deliver respiratory support in the first and second modes, as described with reference to the embodiment of Figures 31-33. describe. Connector 1700 is configured to couple with a standard Y-piece connector 1750 . In normal use, Y-piece connector 1750 is configured to couple at port 1755 with a conduit that provides a flow of breathing gas to a mask 124 of the type shown in Figures 31 and 32. Y-piece connector 1750 receives respiratory gas flow from inspiratory flow path 210 and provides an outflow path for exhaled gas from the patient via expiratory gas flow path 130 . When used consistent with Figure 32, mask 124 forms a sealed interface with the patient's airway for delivering respiratory gases, which may include anesthetic agents, while returning exhaled gases to the respiratory device via expiratory gas flow path 130.

To facilitate interoperability between different patient interfaces, a new connector 1700 may be used that provides a wall 1720 configured to protrude into the Y-piece connector 1750 . When connected, wall 1720 divides flow in inspiratory flow path 210 and expiratory flow path 130 into separate branches 1710 and 1730. In use, the connector 1700 is configured to couple the first branch 1710 with the catheter attached to the nasal cannula 224 and to couple the second branch 1730 with the catheter attached to the mask 124 . Due to the separate wall 1720, the inspiratory flow to the cannula 224 (see Figures 31 and 32) remains separate from the expiratory flow received from the mask 124 (when used in the configuration of Figure 32). To quickly switch to the equipment required for delivery support in the third mode, the connector 1700 can be removed from the Y-piece connector 1750 which is instead coupled to the endotracheal tube 126. Advantageously, connector 1700 can be used to couple and disconnect Y-piece connector 1750 to nasal cannula 224 and mask 124 simultaneously, and where disconnection/reconnection of quick-connect components for endotracheal tube 126 is relatively easy. less, and the range of error is smaller. When switching back to the first support mode with the mask 124 configured to seal over the nasal cannula 224 (as shown in FIG. 32 ), the endotracheal tube 126 is disengaged from the Y-piece connector 1750 and the connector 1700 is reconnected, simultaneously connecting cannula 224 and mask 124.

Figure 35 is a schematic diagram of another connector 1800 that provides for use in the arrangement shown in Figure 32 in place of the standard Y-piece connector 1750. Using connector 1800 , mask 124 is used to remove exhaled gas via expiratory gas flow path 130 . For operation in the second mode (Fig. 32), the connector 1800 may remain in place connecting the mask and the expiratory gas flow path 130, but the connector 1800 is disengaged from the inspiratory gas flow path 210, Inspiratory gas flow path 210 is instead coupled with nasal cannula 224 . One-way valve 1810 is biased for flow in inspiratory gas flow path 210 toward mask 124 , thereby operating to prevent expiratory gas from the mask from venting to the atmosphere due to the absence of inspiratory gas in this mode of operation. The conduit is attached to connector 1800. To operate in the third mode (Fig. 33), the inspiratory catheter can be reconnected to the connector and the mask 124 can be detached and replaced with the connection of the endotracheal tube 126. The advantage of this arrangement is that the connector 1800 can be used to deliver the two respiratory support modes shown in Figures 32 and 33 while avoiding the need to disconnect and reconnect as with a standard Y-piece connector for delivery and removal of gases. All conduits required.

Figure 36 is a schematic diagram of yet another novel connector 1900 configured for use in embodiments in which nasal cannula 224 is used to deliver different modes of respiratory support. Connector 1900 may be coupled with three conduits that provide fluid communication with each of: first inspiratory gas flow path 210A configured to provide for delivery of nasal high flow respiratory support. gas flow; a second inspiratory gas flow path 210B configured to provide a gas flow for delivering anesthesia ventilation; and an expiratory gas flow path for expelling exhaled gas from the patient. A switch 1910 (eg, a switching valve, a solenoid, or the like) is provided to change the internal flow path of the connector 1900 when a different support mode is selected. When nasal cannula 224 is used to deliver anesthetic ventilation, switch 1910 is in the position shown by the solid line, allowing delivery of respiratory gases (including anesthetics) from inspiratory gas flow path 210B and providing a path 130 for exhaled gases. During rebreathing, the bag mask can be applied over the nasal cannula 124 with sufficient pressure applied (eg, by a clinical caregiver) such that the cannula can provide both an inspiratory flow path and an expiratory flow path. . In high flow respiratory support, switch 1910 is in the position shown by the dashed line. Switch 1910 may be operably linked with other switching devices in the system operated by a user (or system controller) to determine the support mode to be delivered.

37A-37B are schematic illustrations of connectors 1950A, 1950B that are variations of connector 1900 of FIG. 36 that provide connections to both nasal cannula 224 and mask 124 . The connectors 1950A, 1950B provide high flow nasal flow delivery when the switch 1910 is in the dashed position. When switch 1910 is in the solid line position, anesthesia ventilation may be provided through cannula 224 with removal of expiratory gases by application of mask 124, with the device arranged as shown in Figure 32. Figure 37A shows connector 1950A with all flow paths in the one-piece connector. 37B illustrates connector 1950B that includes an inspiratory flow path connected to nasal cannula 124 and a separate conduit for providing an expiratory gas flow path 130 attached to mask 124.

Generally, system 1000 for use with the patient interface shown in Figures 31-33 may include a controller 1010 in communication with flow modulator 250, and one or more sensors or input interfaces in communication with the controller to An input is provided to the controller to control the flow modulator to provide a flow of respiratory gas in the first mode or the second mode. The sensor and/or input interface may also be configured to provide input to the controller to control the flow modulator to provide a flow of respiratory gas in the third mode.

The system may also include a humidifier 420, wherein the respiratory gases are heated and/or humidified by the humidifier before being delivered to the patient in the second mode. In some embodiments, the respiratory gas in the first mode and/or the third mode may be heated and/or humidified by humidifier 420. Ideally, in the first and third modes, exhaled gas from the patient is returned to the inspiratory gas flow path 210. CO ₂ absorber 141 may be provided to remove CO ₂ from the exhaled gas before the exhaled gas is returned to inspiratory gas flow path 210 .

Triple lumen tube assembly

Yet another aspect of the present disclosure provides a multi-lumen assembly 1400 for use with respiratory support system 1000, as schematically shown in Figure 20. Multi-lumen assembly 1400 has multiple catheters, as shown in Figure 21. The first inspiratory conduit 1410 has a first conduit inflow end that is coupled to the first gas outlet 1044 of the respiratory support system and is configured to deliver respiratory gases including an anesthetic agent to the patient. The first inspiratory conduit 1410 has a first conduit outflow end that is coupled to a first patient interface 120 configured to sealingly engage and direct airflow into the patient's airway. . In the illustrated embodiment, the first patient interface 120 is schematically shown as a sealing mask, but it should be understood that the first patient interface may be an endotracheal tube, a LMA, or the like.

The second inspiratory conduit 1420 has a second conduit inflow end coupleable with the second gas outlet 1048 of the respiratory support system and is configured to deliver high flow respiratory gas at a flow rate between 20 L/min and 90 L/min. patient. The second suction conduit 1420 has a second conduit outflow end that may be coupled to a second patient interface 220 configured to direct flow into the patient's airway, such as via a three-way safety connector. and may be a non-sealing interface such as a nasal cannula.

The expiratory conduit 1430 has an expiratory conduit outflow end coupleable with the expiratory gas inlet 1046 of the respiratory support system. Exhalation conduit 1430 is configured to return exhaled gases from the patient to the respiratory support system.

In some embodiments, multi-lumen assembly 1400 includes or is operable with connector portion 1415, wherein the outflow end of first inspiratory conduit 1410 and the inflow end of expiratory conduit 1430 form a common gas Flow path 1416. A schematic is provided in Figure 21. The common gas flow path 1416 is defined by a single gas exchange conduit 1417 that can be coupled with the first patient interface 120 . Ideally, the connector portion 1415 includes a taper, for example, a 22 mm taper, to reduce the overall cross-section of the assembly in the area of a single gas exchange conduit 1417. In some embodiments, the connector portion is configured to orient the second conduit outflow end of the second suction conduit 1420 such that the second conduit outflow end bifurcates from a single gas exchange conduit. The connector portion may then be coupled with a second patient interface 220 for delivering high flow respiratory support, such as through a three-way safety connector.

maintain agency

In some embodiments, at least a length of the plurality of catheters is arranged coaxially, with the outer wall of an inner lumen defining the inner wall of the next lumen, as schematically shown in Figure 21. In other embodiments, at least one length of multiple catheters are arranged in parallel, and multi-lumen assembly 1400 includes a mechanism to maintain at least one length of multiple catheters in a group, for example, in a strip (Fig. 22A) (in which the conduits are arranged side by side) or kept in a bundle (Figs. 22B and 22C). In some embodiments, multiple catheters are configured to be inserted into three corresponding "slots" of respiratory support system 1000 to deliver anesthesia and/or ventilation and high-flow respiratory support depending on the selected operating mode of the system. A patient end adapter may be used to plug the first and second patient interfaces into a single connector (eg, connector 1500), or the conduit may be separated along a portion of the assembly to allow independent movement of the patient ends.

In some embodiments, the retention mechanism includes webbing 1452 that is spaced or continuously disposed between at least pairs of the plurality of conduits along at least a length of the plurality of conduits disposed in one. The webbing (or webbing portion) 1452 may be breakable to facilitate detaching at least a length of one or more conduits of the plurality of conduits from the group, for example, to detach a second suction port coupled to the second patient interface 220 . An airway tube 1420 , while the first inspiratory and expiratory tubes are coupled to a single first patient interface 120 .

Alternatively or additionally, the retention mechanism may include a sheath (or skin) 1454 applied around the plurality of catheters, as shown in Figure 22B. Ideally, a portion of the sheath 1454 may be removed from a length of the multi-lumen assembly, for example, to detach the second suction catheter 1420. The sheath may be formed from any suitable material, for example, it may be a plastic extrusion or wrap in the form of a continuous sheet to be woven or an expandable "mesh" that may be stretched over multiple catheters. One benefit of the sheath 1454 formed from a smooth plastic or similar coating is that the sheath 1454 is easy to clean by wiping and has a neat appearance. Advantageously, the patient interface may be displaced, particularly when the patient interface is used in conjunction with a filter 230, which may be assembled with or incorporated as part of the patient interface used. This enables the tri-lumen tube assembly 1400 to be reused on different patients. Alternatively or additionally, the filter 230 may be incorporated into or coupled to the three-lumen tube assembly 1400 such that a single filter can be used with different interchangeable patient interfaces. Additionally, the filter has the ability to carry sensor wiring or gas sampling lines 227 that may be used to route collected exhaled gas or sensor signals from a patient interface (e.g., nasal cannula). Sensors at a second patient interface (forming a second patient interface) are transmitted to the controller 1010 of the respiratory support system 1000, which may be used to control switching between operating modes of the system as described herein.

Alternatively or additionally, the retention mechanism may include one or more retainers or clips 1456 configured to retain two or more of the plurality of conduits in a group. An example of a retainer/clip 1456 having slots for retaining three catheters in a group or bundle is shown in Figure 22C. It will be appreciated that several retainers 1456 may be used to hold the catheter bundle together along a desired length. In some embodiments, retainer/clip 1456 provides slots for accommodating 2, 3, 4, or more conduits, and may also have slots for retaining, for example, sensor wiring or other elongated components. groove. In some embodiments, retainer 1456 is slidable along the length of one or more of the plurality of conduits. Advantages of retainer 1456 are that the position of retainer 1456 on multi-lumen assembly 1400 can be changed as needed, not all slots need to be used, and retainer 1456 can be cleaned and reused. Retainers 1456 may also be used to rejoin conduits that have been separated when a web or sheath has been previously provided.

In some embodiments, the multi-lumen assembly 1400 includes or is operable with a flow switching mechanism operable to direct the flow of respiratory gas to the first inspiratory conduit 1410 or the second inspiratory conduit. 1420 in. The switching mechanism is operable by the user to select a support mode, which in turn determines the flow of respiratory gas into the first or second inspiratory conduit. The switching mechanism is associated or operably coupled with respiratory support system 1000 and may take any suitable form, such as a button, switch, knob, foot switch or pedal or other user-operable actuator. In the embodiment shown, the switching mechanism is schematically shown as a switching lever 700 .

In some embodiments, the switching mechanism is operably linked to the respiratory support system controller 1010 via electronics, enabling a user to switch modes through the use of a touch screen or other electronic interface. In some embodiments, the switching mechanism may be directly coupled with a gas flow splitter that controls flow to the first gas outlet 1044 and the second gas outlet 1048 of the system. Alternatively, electronic switching mechanisms provide a range of flexibility in the location of the switching mechanisms, as well as central control of other components of respiratory support system 1000 (e.g., vaporizers, gas sources, gas mixers, flow modulators, and the like) Potentially, the electronic switching mechanism has functional control of valves and/or air flow diverters or other devices for controlling air flow into the first suction conduit 1410 and the second suction conduit 1420.

FIG. 24 shows an example of a patient-side connector 1500 that can be coupled to a three-lumen assembly 1400 via a connector coupling 1550. In some embodiments, the patient end connector 1500 includes one or more switching elements 1570 operable by a user to switch the connector between a first mode of operation and a second mode of operation in which the connection is connected. The device directs respiratory gases to the first patient interface via first coupling 1510 and directs exhaled gases from the patient to the expiratory flow path via expiratory coupling 130 , the connector via the second coupling in the second operating mode. 1520 directs breathing gas to the second patient interface. Accordingly, switching element 1570 is in operative communication with controller 1010 of respiratory support system 1000 to communicate the selected mode so that the gas delivery system can be configured accordingly. Alternatively/additionally, controller 1500 may receive control signals from system controller 1010 to redirect flow within the controller to direct respiratory gases to the first patient interface, such as by activating valves and/or flow diverters. or second patient interface.

In various embodiments of the multi-lumen assembly 1400 and the actuators and connectors used with or forming part of the multi-lumen assembly, a gas sampling conduit 227 (Fig. 22B) may be provided for monitoring One or more properties of a gas, for example, CO ₂ . These characteristics may be used by the respiratory support system controller to determine whether the first patient interface or the second patient interface is attached to the connector and applied to the patient's airway.

System switching with ^CO2 trigger

Yet another aspect of the present disclosure relates to _CO2 sensing as a means of providing mode switching in systems for delivering respiratory gases to patients. This aspect will be described in the context of a system for providing respiratory support 1000 as described herein, which system is operable to deliver respiratory gas through a first patient interface 120 in a first mode and through a second mode. The second patient interface 220 delivers breathing gas. The system includes one or more _CO2 sensors configured to detect _CO2 in exhaled breath from the patient. The system controller 1010 receives input from one or more _CO2 sensors and operates the switching mechanism based on the detected _CO2 , selects the first mode when the detected _CO2 indicates that the first patient interface is connected to the patient, and when the detected CO2 Detection of _CO2 indicates selection of the second mode when the second patient interface is connected to the patient.

In some embodiments, the system controller 1010 switches control when it is determined that a change has occurred in the detected _CO2 concentration. However, detection of a change is not required as a comparison to a reference value (eg, corresponding to typical ambient _CO2 levels) will be sufficient for the controller to determine whether first patient interface 120 or second patient interface 220 is attached to the patient. Detection of the patient circuit (and patient interface) connected to the patient enables the system controller 1010 to automatically select the correct mode of operation to deliver the required respiratory support to the patient. For example, in a first mode, breathing gas is delivered to the patient's airway through a first patient interface (which may be a sealing interface), and exhaled gas is returned to the system through the exhaled gas flow path. For example, when breathing gases are delivered to the patient in the first mode to provide ventilatory support, exhaled gases may be redirected to the atmosphere or exhaust. Alternatively, the first mode may be a rebreathing first mode in which exhaled gases returned to the system are recirculated via a rebreathing system as disclosed herein for delivery to the patient via the first patient interface. In the first mode of rebreathing, the breathing gas may include one or more volatile anesthetics that are evaporated into the breathing gas by a vaporizer as disclosed herein. In the second mode, respiratory gases may be delivered at a high flow rate of at least 20 LPM (for adults) and up to about 90 LPM, and these gases may be delivered to the patient through a second patient interface 220, which may be a non- Sealing interface, for example, nasal cannula 224.

The system may include a _CO2 sensor associated with a first _breathing circuit for delivering breathing gas in the first mode and/or a second breathing circuit for delivering breathing gas in the second mode, and The controller 1010 may determine the breathing circuit containing the highest concentration of CO ₂ as the breathing circuit attached to the patient, and control gas delivery to the determined breathing circuit according to the associated operating mode.

Typically, the system controller 1010 determines that the first breathing circuit includes the first patient interface ₁₂₀ when one or more _CO sensors detect CO in the exhaled gas in the exhaled gas flow path 130 that returns the exhaled gas to the system. Be attached to the patient. The first patient interface 120 may include a sealing mask 124 or an endotracheal tube 126 as shown in Figures 25 and 26, with a _CO2 sensor (not shown) disposed on the gas flow of the exhalation conduit that returns exhaled gases to the system. in the path. The CO ₂ sensor may be positioned in the body of the system, such as at the exhaled gas inlet or anywhere along the length of the exhaled gas conduit 130 . The nasal cannula 224 shown in Figures 25 and 26 has a nasal prong 226 that can direct high flow respiratory gases into the nostrils of the patient 300.

Since non-sealed patient interfaces do not have a return conduit for exhaled gases, the _CO2 sensor may be located on the patient end of the interface, for example, on the nasal prong 226 or the cannula body attached to the nasal prong. Alternatively, sampling conduit 228 may be used to return sampled gas exiting the nostril to a _CO2 sensor located elsewhere in the device. Accordingly, the sampling conduit 228 may be connected to a gas sampling line 227 (Figs. 27 and 28) that is in fluid communication with a _CO2 sensor that provides input to the system 1000, or may provide fluid communication with the exhalation gas conduit 130 Connected, as shown in Figure 26. Since CO ₂ will rapidly dissipate into the atmosphere, in embodiments in which exhaled gas is directed to exhaled gas conduit 130 via sampling conduit 228 , controller 1010 may be configured to compare the detected lower CO ₂ concentration with a second Associated with the use of non-sealed patient interfaces 220/224.

Sampling conduit 228 may provide flow into expiratory gas conduit 130 , or a separate conduit may be provided in fluid communication with a dedicated gas sampling inlet of system 1000 . Figure 26 shows a cannula 224 and a mask 124 coupled with an expiratory gas conduit 130 (for simplicity, the inspiratory gas conduit 110 is not shown). Sampling conduit 228 directs exhaled gas from the patient's mouth into exhaled gas conduit 130 for sensing by a _CO2 sensor. In this arrangement, the nasal cannula 224 may be used to deliver respiratory gases, which may include an anesthetic agent in the first mode, wherein the mask provides a means to direct exhaled gases via the exhalation path 130 . In some embodiments, the sampling conduit 228 may be decoupled from the expiratory gas conduit of the sealing mask 124 and coupled to the expiratory gas conduit of the endotracheal tube 126 (or vice versa), which enables the use of ventilation, including induction, and ventilation. Sensing was performed during different stages of sedation including ongoing anesthesia and weaning.

A range of different sensing methods can be used as a means of providing mode switching in systems used to deliver respiratory gases to patients. In one example, the pressure in the mask can be monitored by a pressure sensor and used to detect when the mask is in place on the patient. The mask can be placed over the high-flow cannula (as shown in Figure 32), or the mask can replace the cannula. Detection of the mask on the patient may be accomplished by detecting the pressure increase expected during delivery of high-flow respiratory support (consistent with placement of the mask over the cannula), and detection of the mask may indicate intent to use rebreathing loop, and this may facilitate switching from the high flow operating mode of the respiratory support system 100 to the rebreathing mode. Additionally or alternatively, an optical sensor may be disposed in the mask, the optical sensor being configured to monitor changes in emitted/detected light that occur in the presence of the patient's skin, and may be used to detect changes in the mask's effect on the patient's skin. placement on the body. This can be used in conjunction with a pressure sensor in the mask's cuff that detects an increase in pressure when the mask is applied to the patient, which increase in pressure can trigger a controlled switch from high flow mode to rebreathing mode. . Likewise, if opposite changes in these measurements were detected, this would be consistent with removal of the mask from the patient, which would trigger a control switch from rebreathing mode to high flow mode.

Alternatively or additionally, sensing in the exhalation flow path of the rebreathing tube may be utilized to determine when the mask is placed in the appropriate position on the patient to trigger a switch to rebreathing. The mask can be placed over the high-flow cannula (as shown in Figure 32), or it can replace the cannula. One or more parameters in the exhalation flow path (eg, flow, pressure, temperature, or humidity) can be determined using suitable sensors. An increase in one or more of these parameters (e.g., if the sensor determines that the temperature in the exhalation flow path has increased or is above ambient) will indicate that the mask is on the patient and trigger a switch from high flow mode to rebreathing model.

Figures 27 and 28 illustrate another arrangement utilizing a piston drive assembly to selectively direct exhaled gases from each of the first patient interface (mask 124) and the second patient interface (nasal cannula 224). Sampling line 227. Sampling conduit 228 collects exhaled gas from nasal cannula 224 into first chamber 231A of the assembly. This assembly houses a filter 230 (which may be omitted) that receives exhaled gases from the mask 124 and directs the exhaled gases through opening 233 into the first chamber 231A. The second chamber 231B is adjacent the first chamber and is in fluid communication with the filler cuff 125 of the mask 124 . The piston 232 is movable between the two chambers 231A, 231B between a first position (Fig. 27) and a second position (Fig. 28). The first position blocks the flow of gas from sampling conduit 228 to gas sampling line 227, and exhaled gas from mask 124 is received through filter 230 and opening 233 into first chamber 231A and directed to gas sampling line 227 (Fig. 27 ). The second position blocks the flow of exhaled gas from mask 124 to gas sampling line 227, and exhaled gas from sampling conduit 228 is directed to gas sampling line 227 (Fig. 28). When mask 124 is applied to the patient's face for delivery of respiratory gases in the first mode, pressure in cuff 125 increases, moving piston 232 away from the cuff to the first position. The biasing device 234 moves the plunger to the second position when the mask 124 is removed from the patient's face. It will be appreciated that although biasing device 234 is shown in the figures as a resilient biasing device, operation of the plunger may be controlled electronically, mechanically, or otherwise.

In yet another arrangement shown in Figures 29A and 29B, airway pressure, as determined by the pressure in the mask itself, is used to selectively direct expiratory gas into gas sampling line 227. Figure 29A shows the arrangement when using the mask in the first mode, and Figure 29B shows the arrangement when using a nasal cannula (not shown). The gas sampling line 227 has a lower pressure than both the exhalation conduit 130 from the mask and the sampling conduit 228 from the nasal cannula. In Figure 29A, positive pressure in the mask during use in the first mode causes pressure-responsive diverter 235 to open to allow expiratory gas to flow from expiratory conduit 130 into gas sampling line 227 while preventing expiratory gas from flowing from the sampling conduit. 228 (from nasal cannula) flow. In Figure 29B, the mask is removed from the patient such that the pressure in exhalation conduit 130 equals atmospheric pressure. During the second mode of operation, when the diverter 235 is operating in the second mode, the nasal cannula is applied to the patient and the exhaled gas in the sampling conduit 228 increases in pressure due to the pressure differential and due to the arrangement of the diverter 235 , causing the diverter 235 to open to allow exhaled gas to flow from the sampling conduit 228 into the gas sampling line 227 while substantially preventing the flow of exhaled gas from the expiratory conduit 130 .

In yet another arrangement shown in Figure 30, a three-way switch 1600 is actuated by a user to selectively direct expiratory gas from one of a nasal cannula, an endotracheal tube, and a sealing mask into the gas sampling line 227 , the gas sampling line 227 is incorporated into the multi-lumen assembly 1400 in the preferred embodiment. A piston 232 coupled to a user-operated actuator moves within a chamber 231 within the switch housing to direct the flow of exhaled gas according to an operating mode or patient interface selected by the user. As the piston moves distally of multi-lumen assembly 1400, high-pressure expiratory gas from the cannula (via sampling conduit 228) enters chamber 231 and gas sampling line 227 within the multi-lumen assembly. As the piston moves toward the multi-lumen tube assembly 1400, flow from the cannula cannot enter the gas sampling line, but rather exhaled gas enters the gas sampling line from one of the endotracheal tube or mask.

In some embodiments, system 1000 includes a first breathing device 100 that delivers breathing gas in a first mode and a second breathing device 200 that delivers breathing gas in a second mode, as described herein. Accordingly, the first respiratory device 100 may include one or more of the following: a _CO2 absorber configured to treat returning exhaled gases before they are recycled to the patient in the first mode; a pressure limiting a valve configured to maintain a substantially stable pressure in the system in the first mode; a variable volume (e.g., a vent bag or bellows) for displacing gas in the first mode; a fresh gas flow using for supplementing the anesthetic gas delivered to the patient in the first mode; and a vaporizer for vaporizing the volatile anesthetic agent into the respiratory gas delivered to the patient in the first mode. The second respiratory device 200 includes a flow modulator configured to provide a high flow rate through the system, and the second respiratory device 200 typically includes a humidifier configured to provide a high flow rate of the respiratory gas during the second mode to adjust the respiratory gas to a predetermined temperature and/or humidity before delivery to the patient.

In a preferred embodiment, when the second mode is selected, the system isolates the flow of respiratory gases from the first respiratory device to the patient such that no anesthetic agent 300 is delivered to the patient. In some embodiments, the first respiratory device 100 and the second respiratory device 200 are integrated into a unitary machine, although this need not be the case. In either case, the humidifier may be configured to adjust the breathing gas to a predetermined temperature and/or humidity before the breathing gas is delivered to the patient in the second mode.

In some embodiments, system 1000 includes a display device or monitor 1094 in operative communication with system controller 1010 , and the display device or monitor 1094 may be configured to display information based on information received by the system controller from one or more Input from the _CO2 sensor to display one or more _CO2 traces. The system controller 1010 may automatically determine which CO ₂ sensor is signaling for display on the monitor 1094 and thereby select a trace corresponding to the CO ₂ sensor input representing the CO ₂ sensor input from the multiple CO ₂ sensors. The highest _CO2 value detected or the _CO2 value most likely to be similar to the patient value (e.g., above ambient _CO2 concentration). Alternatively, system controller 1010 may cause all _CO2 traces to be displayed simultaneously or cyclically on monitor 1094 or on one or more separate monitors that would be dedicated only to _CO2 monitoring.

Respiratory equipment with humidification function

38-40 illustrate a respiratory device 100 for delivering respiratory gas to a patient 300 in accordance with an embodiment of the present disclosure. Respiratory device 100 includes a flow source 1030 for providing a flow of respiratory gas in an inspiratory flow path for delivery to patient 300 . The respiratory device 100 also includes a bracket 160 for coupling with at least one vaporizer 150 for vaporizing one or more volatile anesthetics into the respiratory gas in the inspiratory flow path prior to delivery of the respiratory gas to the patient 300 . in the gas flow. The respiratory device 100 also includes a return path for recycling exhaled gas received from the patient 300 via the expiratory flow path to the inspiratory flow path. The bracket 160 may be coupled with the humidification component 450 for regulating the flow of respiratory gas in the inspiratory flow path to a predetermined temperature and/or humidity before the respiratory gas is delivered to the patient 300 .

The components of respiratory device 100 as shown and described with reference to Figures 38-40 have similar reference numerals to the components of anesthesia machine 10, ventilator 20, and high flow system 30, which are intended to refer to the same components. Accordingly, descriptions regarding those components of anesthesia machine 10 are considered applicable to respiratory device 100 according to some embodiments of the present disclosure.

Flow source 1030 of respiratory device 100 may include a flow modulator (e.g., flow modulator 250 described with reference to FIG. 2 ), or more specifically a flow generator adapted to receive one or more components external to respiratory device 100 . Breathing gas and creating airflow through the respiratory device 100. The flow generator may be in direct or indirect fluid communication with gas supply 1060 for providing one or more respiratory gases to respiratory device 100 . Gas supply 1060 may be a gas source supplied by one or more hospital gas outlets located, for example, in an operating room or ICU. Gas supply 1060 may be configured to supply nitric oxide (NO), oxygen (O ₂ ), and/or air to the flow generator.

In some embodiments, flow source 1030 includes gas supply 1060. The flow source 1030 and/or the respiratory device 100 may include one or more valve arrangements adapted to control the flow of one or more gases (e.g., one or more of NO, _O2 , and air supplied from the gas supply 1060 species) provides the velocity to the suction flow path. This may also allow for controlled mixing of one or more gases into a desired composition for use with respiratory device 100. In alternative embodiments, flow source 1030 may not include gas supply 1060. Instead, the flow source 1030 may include one or more containers of compressed air and/or another gas and one or more valve arrangements adapted to control the flow of gas out of the one or more containers to The rate at which respiratory gas flow is provided to the inspiratory flow path.

In other embodiments, the breathing device 100 is in gas flow communication with a gas delivery device 1040 that is in fluid communication with a gas supply 1060, as shown by the dashed lines in Figure 38. Gas delivery device 1040 may receive a gas supply including one or more of NO, _O2 , and air from gas supply 1060. The gas delivery device 1040 includes a gas mixing element 1042 for combining one or more of NO, _O2 , and air from the gas supply 1060 in a desired proportion. The proportion of respiratory gas delivered for use by the respiratory device 100 . For example, when respiratory device 100 is operating to provide anesthetic ventilation with one or more anesthetic agents to patient 300 , gas mixing element 1042 may include at least nitric oxide (NO) in the respiratory gas provided to respiratory device 100 . Alternatively, gas mixing element 1042 may include O ₂ and/or air when respiratory device 100 is operating without anesthetic to provide anesthetic ventilation to patient 300 .

The gas delivery device 1040 also includes one or more flow meters 1090 for controlling the flow of respiratory gas provided to the breathing device 100, as shown in Figure 38. Gas delivery device 1040 may include a flow meter 1090 for controlling gas lines delivering each of NO, _O2 , and air (eg, see Figures 54 and 55 with flow meter 190 of breathing device 100). Flow meter 1090 can control gas mixing by varying the flow rate of each respiratory gas provided to respiratory device 100 and thereby varying the proportions of the breathing gases. The gas delivery device 1040 may also include a gas outlet 1044 coupleable with the breathing device 100 for supplying gas from the gas delivery device 1040 to the breathing device 100 .

In other embodiments, respiratory device 100 may include a gas delivery device 1040. The gas delivery device 1040 may be in fluid communication with the flow source 1030 for providing respiratory gas to the flow source 1030 for generating a flow of gas in the inspiratory flow path for delivery to the patient 300 . Alternatively, gas delivery device 1040 may replace flow source 1030 such that gas outlet 1044 provides a flow of respiratory gas directly to the inspiratory flow path.

The respiratory device 100 provides an inspiratory flow path through which a flow of respiratory gas is directed into the patient's airway 310 . The flow of respiratory gas from flow source 1030 may be adjusted and/or modified in the inspiratory flow path before the respiratory gas is delivered to patient 300 . As shown in Figure 38, respiratory gas flow may be directed from flow source 1030 (or gas supply 1060 and/or gas delivery device 1040) to vaporizer 150, humidification component 450 external to respiratory device 100, or directly to the inspiratory Duct 110 or suction duct 120. Options for directing the flow of breathing gas may be controlled by the controller 1010 of the breathing device 100 . Additionally, a switching mechanism 1020 may be provided to control switching between options for directing the flow of respiratory gas in the inspiratory flow path. This will be described in more detail with reference to Figures 52 and 49.

Respiratory device 100 may be operated in various operating modes, such as by controller 1010. The respiratory device 100 may be operable in a first mode in which the respiratory device 100 delivers respiratory gas to the inspiratory flow path and receives return of exhaled gas via the expiratory flow path. The first operating mode may be an anesthetic ventilation mode, which may include providing ventilatory support with or without one or more anesthetic agents. Typically, respiratory gas is delivered at a low flow rate, such as less than about 15 L/min. In the first mode, the breathing gas may include one or more of NO, _O2 , and air. The breathing gas may optionally include one or more anesthetic agents, such as nitric oxide from flow source 1030 and/or one or more volatile agents from vaporizer 150 for respiratory device 100 in anesthesia ventilation mode. operations in.

In a first mode, respiratory gas flow may be directed from flow source 1030 to vaporizer 150 or directly to inspiratory conduit 110 for delivery to patient 300, as shown in Figure 38. When the respiratory gas flow is directed to at least one vaporizer 150, the respiratory gas flow may be modified to optionally include one or more volatile anesthetics that are vaporized into the gas flow. The one or more volatile anesthetics may include isoflurane or sevoflurane that is converted from liquid to vapor by vaporizer 150 . The flow of respiratory gas with optional anesthetic is then directed to the inspiratory conduit 110 for delivery to the patient's airway 310 via the first patient interface 120 . The first patient interface 120 may form a sealed interface with the patient's airway 310 and may include a mask or endotracheal tube. The first patient interface 120 may include a laryngeal mask airway (LMA) or a sealing mask.

Respiratory device 100 also provides an expiratory flow path through which a flow of exhaled gas from patient 300 is received. The first patient interface 120 may be configured to receive exhaled gas from the patient 300 in the first mode, as shown in FIG. 38 . Exhaled gases may flow through the expiratory conduit 130 , which is coupled to the rebreathing component 140 of the breathing device 100 . The rebreathing component 140 includes at least one _CO2 absorber 141 configured to process exhaled gases returning from the patient 300 before the exhaled gases are recycled to the inspiratory flow path in the first mode. Rebreathing component 140 may also include one or more of ventilation bag 142, pressure relief valve 143, scavenger system 144, bellows 145, and pressure relief valve 146, as described with reference to anesthesia machine 10 of Figure 1A. The breathing device 100 therefore provides a return path for recirculating exhaled gas from the patient 300 via the rebreathing component 140 to the inspiratory flow path in the first mode.

The respiratory device 100 may also be operable, such as by the controller 1010 , in a second mode in which the respiratory device delivers respiratory gas at a predetermined flow rate to the inspiratory flow path without returning exhaled gas from the patient 300 . The second mode may be a high flow mode for delivering high flow respiratory support. Typically, breathing gas is delivered at a high flow rate, such as in the range of about 20 L/min to about 90 L/min or in the range of about 40 L/min to about 70 L/min. In other embodiments, the predetermined flow rate may include about 20 L/min, about 40 L/min, or about 70 L/min. The breathing gas may include _O2 and/or air in the proportions required by operation of the breathing device 100 in the second mode.

In the second mode, the respiratory gas flow may be directed from the flow source 1030 to the humidification component 450, and the respiratory gas may then be provided directly or indirectly to the second inspiratory conduit 210 for delivery to the patient 300, as shown in Figure 38 shown. When the respiratory gas flow is directed to the humidification component 450, the humidification component 450 is operable to condition the respiratory gas flow in the inspiratory flow path to a predetermined temperature and/or humidity before the respiratory gas is delivered to the patient 300. Humidification component 450 may be operable to heat the flow of respiratory gas to a predetermined temperature. The predetermined temperature and/or humidity may include temperature and/or humidity values or ranges of values suitable for delivering ventilatory support, particularly high flow respiratory support, to the patient 300 . However, it will be appreciated that in some embodiments it may be desirable to enable humidification component 450 to provide humidification and/or warming of gas during support delivery in the first rebreathing mode, and to enable vaporizer 150 to do so.

Humidification component 450 may operate in at least an invasive mode (e.g., for a patient with a bypass airway) and/or a non-invasive mode (e.g., for a patient or user with a respiratory mask or nasal cannula) . Each mode can have multiple humidity settings, which can be expressed as dew point or absolute humidity. The humidification component 450 may be controlled to deliver humidified gas having a dew point (or absolute humidity) at or near a predetermined humidity level at the outlet port 408 of the humidification chamber 400 and/or the patient end of the suction conduit 210 ). For example, the user or clinician can select settings appropriate to the current mode of operation. Many humidity settings are available. For example, the humidity setting may correspond to 37°C, 31°C, 29°C, 27°C, or other dew points. A humidity setting equivalent to a dew point of 37°C would be suitable for invasive treatment (i.e., without bypassing the patient's upper airway), while other humidity settings would be suitable for non-invasive respiratory support, but the humidity setting may not be limited to a specific Types of respiratory support. Alternatively, each humidity setting can be continuously variable between upper and lower limits. The user or clinician may select a lower humidity setting to reduce condensation or "wetting" in the suction conduit 210, or a higher humidity setting may be selected to increase patient comfort or physiological benefit. Some of the humidification components 450 disclosed herein may also include high flow, non-sealed modes, or any other mode as known to those skilled in the art.

Humidification component 450 can provide different levels of humidity for different respiratory support applications. For example, the humidification component 450 may deliver a desired humidity level of approximately 44 mg/L BTPS (full saturation at approximately 37°C) for invasive and/or high-flow respiratory support and/or approximately 44 mg/L BTPS for non-invasive forms of respiratory support. Desired humidity level of 32mg/L BTPS (full saturation at approximately 31°C). Other suitable patient comfort settings may also be delivered for various forms of respiratory support.

The conditioned respiratory gas flow from the humidification component 450 may be directed to the second inspiratory conduit 210 and a second patient interface 220 that may be coupled with the patient's airway 310 . The second patient interface 220 may form a non-sealing interface with the patient's airway 310 and may include a nasal cannula. Alternatively, the conditioned respiratory gas flow may be returned to the respiratory device 100 and then exhausted through a dedicated outlet 164 for delivery to the patient 300 (see also Figure 39). In this case, the second inspiratory conduit 210 may be coupled with the outlet 164 to deliver the regulated flow of respiratory gas to the patient's airway 310 . Additionally/alternatively, the respiratory device 100 may also enable a conditioned respiratory gas flow from the humidification component 450 to be directed to the first inspiratory conduit 110 in the first operating mode. Therefore, some humidification functionality can also be utilized in the first operating mode if desired by the anesthetist or clinician.

Importantly, in some embodiments, the respiratory device 100 does not allow a flow of respiratory gas with anesthetic agent to be directed to the patient 300 in the second mode. Operation of humidification component 450 may prevent delivery of one or more volatile anesthetic agents into the respiratory gas flow in the inspiratory flow path. More specifically, operation of humidification component 450 may inhibit operation of at least one vaporizer 150 or all vaporizers 150 in respiratory device 100 . For example, respiratory device 100 may include a one-way valve or other arrangement to prevent airflow, particularly any volatile anesthetic agent, from passing from vaporizer 150 to second inspiratory conduit 210 when humidification component 450 is operated. Such an arrangement has been described above.

Respiratory device 100 may advantageously enable selective operation of one or more vaporizers 150 and humidification components 450. Respiratory device 100 may include an optional switching mechanism 1020 as shown in Figure 38 to enable selective operation of vaporizer 150 or humidification component 450, if neither is selected, airflow is directed to as shown Suction duct 110 or suction duct 210 . Switching mechanism 1020 may be configured for operation depending on the operating mode of respiratory device 100, which will be described in greater detail.

Figures 39 and 40 illustrate additional components of a respiratory device 100, shown as an anesthesia machine having similar features to the anesthesia machine 10 shown in Figure 1A. The respiratory device 100 may include a module 180 with an auxiliary _O2 flow meter and suction regulator. The respiratory device 100 may also be configurable to be in gas flow communication with one or more flow meters 190 (see also Figures 54 and 55) having a configuration similar to that shown in Figures 38 and 55. The operation of one or more flow meters 1090 of the gas delivery device 1040 is used to control the flow/mixing of gas in the breathing device 100 . Respiratory device 100 may be configurable in gas flow communication with flow meter 190 for controlling gas flow including one or both of air and _O2 in the second mode.

The respiratory device 100 may be configured to be in gas flow communication with one or more of the following: pressure limiting valves 143, 146 configured to maintain a substantially stable pressure in the respiratory device 100 in the first mode ; a variable volume or bellows 145 for displacing gas in the first mode; a fresh gas flow (FGF) (see also Figures 56 and 57) for supplementing the gas delivered to the patient 300 in the first mode; breathing gas; and a vaporizer 150 for vaporizing one or more volatile anesthetic agents into the respiratory gas flow before the breathing gas is delivered to the patient 300 in the first mode. See also, for example, the components of anesthesia machine 10 in Figure 1A. The respiratory device 100 may also include two monitors, a patient monitor 192 and a system monitor 194, for displaying information useful to the operator of the respiratory device 100.

Respiratory device 100 also includes a bracket 160 that can be coupled to vaporizer 150 and humidification component 450, as shown in Figure 39. The bracket 160 may include a plurality of slots for receiving a housing of the evaporator 150 and humidification component 450 . The housings of the evaporator 150 and humidification component 450 may be slidably received in the slots of the bracket 160 . In Figure 40 the empty slot of the holder 160 is shown, in which the humidification component 450 has been removed. Bracket 160 may enable at least one vaporizer 150 and humidification component 450 to be mountable on respiratory device 100 adjacent one another, as shown in FIG. 39 . Evaporator 150 and humidification component 450 may be positioned on rack 160 in a side-by-side arrangement. The housings or parts thereof of the evaporator 150 and the humidification component 450 may be cooperatively engaged with each other, as will be described with reference to FIGS. 46 to 51 .

In some embodiments, the bracket 160 may be coupled with two or more evaporators 150 (not shown) in addition to the humidification component 450. The humidification component 450 may be positioned on the bracket 160 with the evaporator 150 located on either side of the humidification component 450 . This may enable the housing of the humidification component 450 to cooperatively engage the housing of each evaporator 150, for example, to inhibit operation of both evaporators 150 when the humidification component 450 is operating. This will be described in more detail with reference to Figures 46 to 51. The bracket 160 may also include a heating element 162 as shown in Figure 40 as a heating coil, which will be described in greater detail with reference to Figure 43. However, heating element 162 is optional and may not be included in bracket 160 .

41-44 illustrate different embodiments of a humidification component 450 for use with a respiratory device 100 for delivering respiratory gases to a patient 300, in accordance with some preferred embodiments of the present disclosure. Respiratory device 100 includes a flow source 1030 for providing a flow of respiratory gas in an inspiratory flow path for delivery to patient 300 . The respiratory device 100 also includes a bracket 160 for coupling with at least one vaporizer 150 for vaporizing one or more volatile anesthetics into the respiratory gas in the inspiratory flow path prior to delivery of the respiratory gas to the patient 300 . in the gas flow. The respiratory device 100 also includes a return path for recycling exhaled gas received from the patient 300 via the expiratory flow path to the inspiratory flow path. Humidification component 450 may be coupled to frame 160 of respiratory device 100 for regulating the flow of respiratory gas in the inspiratory flow path to a predetermined temperature and/or humidity before the respiratory gas is delivered to patient 300 .

Humidification component 450 may be configured for use with respiratory device 100 of Figures 38-40, as described in the embodiments herein. Therefore, for the sake of brevity, the description of the components of respiratory device 100 will not be repeated. The humidification component 450 may include a humidification chamber 400 as shown in Figure 39 and Figures 41-44, through which the respiratory gas is received and adjusted to a predetermined temperature and/or humidity. For example, in the embodiment of Figure 39, the humidification chamber 400 may be built into the housing of the humidification component 450 and/or be a replaceable component. The user may be able to refill the liquid in the humidification chamber 400. In some embodiments, the humidification chamber 400 is configured to couple with the bracket 160 and may be slidably received onto the bracket 160 , such as via a housing 422 received in a slot of the bracket 160 . Humidification chamber 400 having housing 422 may be slidably received in the slot along a plane substantially horizontal to bracket 160 .

Figure 41 shows an embodiment of a humidification component 450 comprising a housing 422 having a humidification chamber 400 through which breathing gas is received from the respiratory device 100 and conditioned to a predetermined temperature and/or humidity. Humidification chamber 400 includes an inlet port 406 for receiving a flow of respiratory gas from respiratory device 100 and a return port 408 that is coupled to respiratory device 100 for returning a conditioned flow of respiratory gas. . The humidification chamber 400 includes a heating element 404, such as a heating coil, to heat the liquid in the humidification chamber 400. Humidification chamber 400 is configured to be electrically connected with respiratory device 100 for operation of the humidification chamber. Heating element 404 is electrically connected to bracket 160, as shown in Figure 41.

Figure 42 shows another embodiment of a humidification component 450 that includes a housing 422 that includes a humidifier 420 having a humidification chamber 400 that may be coupled to A humidification base unit 410 for operation of the humidification chamber 400 is coupled. The humidification chamber 400 may be slidably coupled with the humidification base unit 410 . The humidification chamber 400 may be slidably coupled such that the humidification chamber 400 is received along a substantially horizontal plane of the humidification base unit 410 . For example, US Patent 5,445,143, the disclosure of which is incorporated herein by reference, discloses a humidification chamber that operates in a substantially horizontal plane on a base, which would be suitable for embodiments of the present disclosure.

In some embodiments, humidification base unit 410 is configured to couple with bracket 160 . The housing of humidification base unit 410 may be configured to be slidably received on bracket 160 . For example, the bracket 160 may include a plurality of slots, and the housing of the humidification base unit 410 may be slidably received into one of the slots, for example, as shown by the bracket 160 of FIG. 40 . The humidification base unit 410 or its housing may be slidably received in a similar manner to the humidification component 450 described with reference to Figures 39 and 40.

Humidification chamber 400 includes an inlet port 406 for receiving a flow of respiratory gas from respiratory device 100 and an outlet port 414 for delivering a conditioned flow of respiratory gas to patient 300 . The outlet port 414 may be coupled with the suction conduit 210 for delivering a regulated flow of respiratory gas to the patient 300 via a patient interface (eg, a sealed or non-sealed patient interface). Inspiratory catheter 210 may be coupled with a second patient interface 220 (eg, a nasal cannula) for delivering respiratory gases to the patient's airway 310 . Humidification base unit 410 includes a heating element 412, such as a heating coil, to heat the liquid in humidification chamber 400. The heating element 412 of the humidification base unit 410 is electrically connected to the bracket 160, as shown in Figure 42.

Figure 43 illustrates yet another embodiment of a humidification component 450 that includes a housing 422 having a humidification chamber 400 that includes an inlet end 406 and a return end 408, similarly In Figure 41. In this embodiment, the humidification chamber 400 includes a conductive plate 402 coupled to the heating element 404 in the bracket 160, as shown in Figure 40. The conductive plate 402 is heated when the heating element 404 in the bracket 160 operates and transfers the heat to the humidification chamber 400 to heat the liquid in the humidification chamber 400 .

Figure 44 shows yet another embodiment of a humidification component 450 similar to Figure 42. In this embodiment, the humidification chamber 400 includes a return port 408 for returning the conditioned flow of breathing gas to the breathing device 100 . The outlet port 414 is excluded and cannot couple with the patient's airway 310 . In this embodiment, respiratory device 100 may include an outlet port 164 through which the conditioned respiratory gas flow from humidification component 450 is delivered to the inspiratory flow path, as shown in FIG. 39 . The outlet port 164 may be coupled to the suction conduit 210 and deliver a flow of respiratory gas to the patient's airway 310 via the second patient interface 220, as shown in Figure 38.

In some embodiments, the humidification chamber 400 includes a liquid inlet connected to a reservoir for refilling the humidification chamber 400. The humidification chamber 400 may also include a flow control mechanism to control the flow of liquid into the humidification chamber 400 . The humidification chamber 400 may include at least one sensor for detecting the liquid level in the humidification chamber 400 . The humidification chamber 400 may include a float valve for controlling the liquid level in the humidification chamber 400 . For example, U.S. Patent 5,445,143, the disclosure of which is incorporated herein by reference, discloses a dual float valve humidification chamber that would be suitable for embodiments of the present disclosure.

In some embodiments, humidification component 450 may be coupled to bracket 160 via adapter 430. 45 illustrates an exemplary adapter 430 for coupling humidification component 450 with respiratory device 100 to deliver respiratory gases to patient 300. Adapter 430 may be coupleable to bracket 160 of respiratory device 100 . Adapter 430 may be received in the slot of bracket 160 in place of evaporator 150 or humidification component 450.

As shown in Figure 45, the adapter 430 includes a first inlet port 432 for receiving a flow of respiratory gas from the respiratory device 100 and a first outlet port 433 for The respiratory gas flow is delivered to humidification component 450. Adapter 430 also includes a second inlet port 434 for receiving the conditioned flow of respiratory gas from humidification component 450 . The conditioned flow of respiratory gas is delivered to the patient 300 or respiratory device 100 via the second outlet port 435 on the adapter 430 . In some embodiments, when humidification component 450 is coupled directly to suction conduit 210 to deliver a conditioned flow of respiratory gas to the patient's airway 310 (eg, see Figure 42), second inlet port 434 and Second exit port 435.

45 illustrates adapter 430 configured to be electrically connected to respiratory device 100 for operation of humidification component 450. For example, adapter 430 as shown in FIG. 45 includes a first power connector 436 for electrically connecting adapter 430 to respiratory device 100. Adapter 430 also includes a second power connector 437 for electrically connecting humidification component 450 with adapter 430 . Therefore, the humidification component 450 can be powered through the adapter 430 connected to the respiratory device 100. However, it should be understood that the humidification may alternatively/additionally be configured to be electrically connected to a battery or other self-contained power source as those skilled in the art will understand.

Advantageously, in some embodiments of the present disclosure, operation of humidification component 450 prevents delivery of one or more volatile anesthetic agents into the respiratory gas flow in the inspiratory flow path. More specifically, operation of humidification component 450 inhibits operation of at least one evaporator 150, as described with reference to FIG. 38 . Respiratory device 100 may include an interlock mechanism to prevent humidification component 450 and at least one vaporizer 150 from operating simultaneously. The interlock mechanism may be configured to enable operation of the humidification component 450 or the at least one evaporator 150 when in the unlocked configuration and to disable operation of the humidification component 450 or the at least one evaporator 150 when in the locked configuration. 46-49 illustrate an exemplary interlocking mechanism of respiratory device 100 in accordance with some embodiments of the present disclosure.

Figure 46 shows an evaporator 150 including a housing 152 having a dial 158 to provide an on/off switch when the dial is rotated by a user. Evaporator 150 includes a locking element associated with housing 152 . The locking element 152 includes two locking pins 154A and 154B that are retractable within the housing 152 in the locked configuration and extendable from the housing 152 in the unlocked configuration. Each locking pin 154A and 154B may be independently retractable within housing 152 in the locked configuration and extendable from housing 152 in the unlocked configuration. In some embodiments, locking element 152 may include only a single locking pin, such as locking pin 154B, as will be understood by those skilled in the art.

47A to 47C are schematic diagrams of the operation of the interlock mechanism of the evaporator 150 of FIG. 46 . In Figure 47A, dial 158 is rotated to the open position and locking pins 154A and 154B extend from housing 152. In Figure 47B, dial 158 is rotated to the closed position and locking pins 154A and 154B are retracted toward housing 152. In Figures 47A and 47B, the vaporizer 150 is maintained in an unlocked configuration in which the dial 158 can be rotated by a user between on/off positions to enable or disable operation of the vaporizer 150. In Figure 47C, external force is applied to locking pin 154A such that locking pin 154A is fully retracted within housing 152 and is not visible. The external force may be applied by the user or, more preferably, by a corresponding locking element associated with the housing 422 of the humidification component 450, as will be described. In this state, the evaporator 150 is now in a locked configuration where the dial 158 is disabled and cannot rotate between the on/off positions. Evaporator 150 is in the locked configuration in the closed position on dial 158 . Evaporator 150 will only be able to operate when external force is removed and/or locking pin 154A is released from within housing 152 .

Figure 48 shows the evaporator 150 of Figure 46 positioned adjacent the humidification component 450. The humidification component 450 includes a housing 422 having a dial 428 to provide an on/off switch when the dial 428 is rotated by the user. Humidification component 450 includes a locking element associated with housing 422 . The locking element includes two locking pins 424A and 424B that are retractable within the housing 422 in the locked configuration and extendable from the housing 422 in the unlocked configuration. In some embodiments, the locking element includes only a single locking pin, such as locking pin 424A, as will be understood by those skilled in the art.

The evaporator 150 and humidification component 450 may include the same locking element as shown in Figure 48. The vaporizer 150 and the humidification component 450 may be mounted adjacent to each other on the respiratory device 100, such as by being coupled adjacent to each other on the bracket 160, as shown in Figure 39, so as to cooperate with each other. Accordingly, the evaporator 150 and humidification component 450 may be configured to cooperate with each other to provide an interlocking mechanism. Additionally, a locking element of the evaporator 150 or humidification component 450 may be configured to engage a corresponding locking element of the other of the evaporator 150 or humidification component 450 to provide an interlocking mechanism.

49A to 49B are schematic diagrams showing the evaporator 150 and the humidification component 450 having the interlocking mechanism of FIG. 48 . In Figure 49A, evaporator 150 is switched to the open position by rotating dial 158, and locking pins 154A and 154B extend from housing 152. Since the evaporator 150 is positioned adjacent to the humidification component 450, the locking pin 154B of the evaporator 150 is pressed against the locking pin 424A of the humidification component 450, causing the locking pin 424A to retract within the housing 422 of the humidification component 450 and in Figure 49A is invisible. In this state, the humidification component 450 is now in a locked configuration where the dial 428 is disabled and cannot rotate between the on/off position. The humidification component 450 is in the locked position in the closed position. Humidification component 450 will only be able to operate when evaporator 150 is switched to the off position (by rotating dial 158 to the off position to enable locking pin 424A to extend from housing 422).

Figure 49B shows the relative arrangement of the interlocking mechanisms of Figure 49A. In this embodiment, humidification component 450 is switched to the on position by turning dial 428 and locking pins 424A and 424B extend from housing 422 . Locking pin 424A presses against locking pin 154B of evaporator 150, causing locking pin 154B to retract within housing 152 of evaporator 150 and is not visible in Figure 49B. In this state, the evaporator 150 is now in a locked configuration where the dial 158 is disabled and cannot rotate between the on/off positions. The evaporator 150 is in a locked configuration in the closed position. The evaporator 150 will only be able to operate when the humidification component 450 is switched to the off position (by rotating the dial 428 to the off position to enable the locking pin 154B to extend from the housing 422).

It is advantageous for the locking element of the evaporator 150 and the humidification part 450 to comprise a pair of locking pins, one on each side of the housing of the evaporator 150 and the humidification part 450 . Usefully the rack 160 can receive one or more evaporators 150 and humidification components 450 simultaneously. If the humidification component 450 is positioned between the two evaporators 150, this causes both evaporators 150 to be disabled when the humidification component 450 is operating, as the locking pins 424A and 424B will engage the locking pins 154A of both evaporators 150. and one of 154B was recovered.

It should be understood that the humidification component 450 and the evaporator 150 may be operable using manual or electronic switching controls to achieve various operating states, for example, wherein operation of the humidification component 450 is enabled while the evaporator 150 is enabled, or wherein evaporation is enabled. The evaporator 150 is disabled while operation of the humidification component 450 is disabled, or the evaporator 150 is disabled while the operation of the humidification component 450 is enabled, or the evaporator 150 is disabled while the operation of the humidification component 450 is disabled.

Figures 50 and 51 illustrate another interlocking mechanism in accordance with some embodiments of the present disclosure. In Figures 50 and 51, the evaporator 150 and humidification component 450 each include slots associated with their respective housings. For the sake of simplicity, Figures 50 and 51 only show the dial 158 of the evaporator 150 and the dial 428 of the humidification component 450, excluding the corresponding housings. Dials 158, 428 can be rotated by the user to switch the evaporator 150 and humidification component 450 to on/off positions. Dial 158 of evaporator 150 includes slot 156 and dial 428 of humidification component 450 includes slot 426 . Locking pin 460 is slidably moveable between slots 156, 426 to provide an interlocking mechanism.

As shown in Figure 51A, locking pin 460 can be positioned within slot 426 of humidification component 450 by sliding pin 460 from slot 156 to slot 426. The user may be able to operate the locking pin 460 and slide it between the slots 156, 426. In this state, the humidification component 450 is in a locked configuration because the dial 428 cannot rotate due to the presence of the lock pin 460. Because the dial 158 can be rotated between on/off positions, the vaporizer 150 is in an unlocked configuration. In FIG. 51B , locking pin 460 may be positioned within slot 156 of evaporator 150 . In this state, the evaporator 150 is in a locked configuration because the dial 158 cannot rotate due to the presence of the locking pin 460 . In contrast, the humidification component 450 is in the unlocked configuration and the dial 428 can be rotated to the open position as shown, thereby preventing operation of the evaporator 150 .

In other embodiments, the interlocking mechanisms and locking elements shown in Figures 46-51 may be incorporated into different operating mechanisms, as will be understood by those skilled in the art. For example, the locking element may comprise one or more resilient members or springs instead of a locking pin. Locking elements may include other forms of mechanical interlocking components such as, for example, levers, levers, latches, and locks.

Figure 52 illustrates that respiratory device 100 may include a switching mechanism 1020 (not shown, see also Figures 38 and 53) configured to selectively operate humidification component 450 and at least one vaporizer 150. In some embodiments, the respiratory device 100 may include two or more vaporizers 150, and the switching mechanism 1020 may selectively operate the two or more vaporizers 150 and the humidification component 450. Depending on the mode of operation (see also Figure 38), the switching mechanism 1020 may direct the respiratory gas flow from the flow source 1030 (or from the gas delivery device 1040, as previously described) to one of the vaporizers 150, the humidification component 450, or Directly to the patient 300 via the first suction conduit 110 or the second suction conduit 120 .

Once the switching mechanism is activated to operate humidification component 450, operation of one or more evaporators 150 may be prevented until the switching mechanism is deactivated. Similarly, when the switching mechanism is activated to operate one of the evaporators 150, the humidification component 450 and/or the other evaporators 150 may be prevented from operating until the switching mechanism is deactivated.

Switching mechanism 1020 may include one or more of an airflow diverter, a bistable switch, a pneumatic switch, a rotary switch, a lever, a knob, or other user-operable actuator. For example, the switching mechanism 1020 may include each of the evaporator 150 and the humidification component 450 operable by a switch. The switch can be a mechanical switch or an electronic switch. The switch may be a rotary switch operable by the user through rotation of dial 158 on evaporator 150 and dial 428 on humidification component 450, as described with reference to Figures 46-51.

Figure 53 is a schematic diagram illustrating a mechanical interlock switch for the vaporizer 150 and humidification component 450 in the respiratory device 100, in accordance with some embodiments of the present disclosure. In this embodiment, flow source 1030 includes a gas delivery device 1040 that supplies source gas via gas supply 1060 . Source gases include NO, _O2 , and air, which are in turn delivered through gas mixing element 1042 and/or flow meter 1090 to provide the desired composition and flow of breathing gas in respiratory device 100. The respiratory gas flow may then be delivered through the vaporizer 150 or the humidification component 450, depending on which of the switches 158 or 428 is operable. The switches of the evaporator 150 and the humidification component 450 may be linked together to prevent the humidification component 450 and the evaporator 150 from operating simultaneously.

The switching mechanism 1020 may also be coupled with an interlocking mechanism of the respiratory device 100, as described with reference to Figures 46-51. When switching mechanism 1020 is activated to operate humidification component 450, the interlock mechanism enables operation of humidification component 450 and disables operation of evaporator 150 due to the mechanical interlock switch. When switching mechanism 1020 is activated to operate evaporator 150, the interlock mechanism enables operation of evaporator 150 and disables operation of humidification component 450 due to the mechanical interlock switch.

Activation and disabling of each of the one or more evaporators 150 and humidification components 450 may be performed by various suitable means, and in some embodiments may involve electronic and/or mechanical actuators. These actuators may be operably linked to the switches and interlocks discussed with reference to Figures 42-51 that enable selective operation of the humidification component 450 and the at least one evaporator 150. For example, an electronic actuator controlled by the interlock feature and the switching feature may cause the power supply to the humidification component 450 to be changed, for example, to reduce the humidity to zero or a lower/negligible amount. In another example, electronic actuators controlled by interlock features and switching features may cause the power supply to one or more vaporizers 150 to be changed, for example, to reduce the release of anesthetic agent to zero or lower/possible Ignore the amount. In yet another example, the mechanical actuator controlled by the interlocking and switching features may include one or more valves, such as a shutoff valve or diverter valve, which may reduce or obstruct the flow path into or out of the component. Alternatively or additionally, one or more solenoids or proportional valves may be provided downstream or at the outlet of the humidification component 450 and/or the evaporator 150 (or at the inlet of the evaporator) to increase or decrease the flow rate. Enable/disable these widgets. In other embodiments, when vaporizer 150 is disabled, the vaporizer may still form part of the flow path through which gas is delivered to the patient, but in other cases, the flow path may be maintained by using shut off with a stop valve, solenoid or similar.

Figure 54 is a schematic diagram of three gas lines supplied to respiratory device 100, and wherein respiratory device 100 includes multiple flow meters 190 in some embodiments. In Figure 54, respiratory device 100 is supplied with a gas source including nitric oxide (NO), oxygen ( _O2 ) and/or air, for example via flow source 1030 or gas source 1060, as shown in Figure 38. The NO gas line includes a flow meter 190A and the air gas line includes a flow meter 190B to control the flow rate for gas mixing to the desired composition for delivering the flow of respiratory gas to the patient 300 . In this embodiment, the O _gas line includes flow meter 190C and flow meter 190D. The operation of the flow meters 190C and 190D in the oxygen line is controlled by the switching mechanism 700.

When respiratory device 100 is operating in the first mode, which may be an anesthetic ventilation mode (eg, providing ventilatory support with or without anesthetic), switching mechanism 700 disables O gas with flow meter _190D Pipeline operations. In contrast, when respiratory device 100 is operating in the second mode, which is ideally a high-flow respiratory support mode, switching mechanism 700 disables operation of flow meter 190C and enables operation of flow meter 190D to For delivering _O2 and/or air to the patient 300 at a fixed flow rate. The flow rate may range from about 20 L/min to about 90 L/min. The flow rate may range from about 40 L/min to about 70 L/min. The flow rate may be about 20L/min, about 40L/min, or about 70L/min.

Figure 55 is another schematic diagram of the three gas lines supplied to the breathing device 100, including three flow meters 190A, 190B, and 190C, and including two additional flow meters 190E and 190F operable on _{the O} gas line. When respiratory device 100 is operating in the second mode, which is ideally a high flow respiratory support mode, switching mechanism 700 disables operation of flow meter 190C and enables operation of one of flow meters 190E and 190F. As shown in Figure 55, flow meter 190E can deliver _O2 to the patient 300 at a flow rate of approximately 40 L/min, and flow meter 190F can deliver _O2 to the patient 300 at a flow rate of approximately 70 L/min.

Figures 56 and 57 illustrate airflow through the breathing device 100 in two operating modes controlled by the switching mechanism 1020 as previously described. The switching mechanism 1020 may be operable in conjunction with the interlocking mechanism described with reference to Figures 41-46 to change the operating mode of the respiratory device 100. The schematic diagram shown is greatly simplified compared to the schematic diagram of Figure 38 and excludes the evaporator 150 in the inspiratory flow path to the inspiratory conduit 110 and excludes the expiratory flow path including the rebreathing component 140 in components inside.

Figure 56 illustrates a first mode of operation of respiratory device 100 in which respiratory device 100 delivers respiratory gas to the inspiratory flow path and receives return of exhaled gas via the expiratory flow path. Breathing device 100 receives a fresh gas flow (FGF) that is a gas (eg, one or more of NO, O ₂ , and air) and/or supplements the gas flow through rebreathing component 140 A mixture of one or more anesthetics. The flow is directed to an inspiratory conduit 110 for delivering a flow of respiratory gas to the patient's airway 310 via the first patient interface 120 (see also Figure 38). Exhaled gas is received from _patient 300 via exhalation conduit 130, which forms return path 140 with _CO2 absorber 141, which is configured to recirculate exhaled gas in the first mode The exhaled air returning from the patient 300 is processed before reaching the patient 300 .

In Figure 57, switching mechanism 1020 allows respiratory device 100 to operate in a second operating mode in which respiratory device 100 delivers respiratory gas at a predetermined flow rate without exhaled gas returning from patient 300. Inspiratory flow path. In the second mode, the breathing device 100 receives a fresh gas flow (FGF), which is a mixture of _O2 and/or air without any (volatile or non-volatile) anesthetic agent. The air flow is directed to a humidification component 450 to condition the flow of respiratory gas to a predetermined humidity and/or temperature prior to delivery to the patient 300 . The conditioned respiratory gas flow is then delivered to the patient 300 via the second patient interface 220 through the inspiratory conduit 210 . Alternatively, in the second mode, the conditioned respiratory gas flow may be delivered directly from the humidification chamber 450 to the inspiratory conduit 210 without returning to the respiratory device 100 .

In the second mode of operation, the CO ₂ absorber 141 may be further configured to condition the respiratory gas in the inspiratory flow path to a predetermined temperature and/or humidity before the respiratory gas is delivered to the patient 300 . The CO ₂ absorber 141 in the second mode may be configured by changing the amount of soda-calcium present in the CO ₂ absorber 141 and by changing the amount of CO ₂ provided to the soda-calcium present in the CO ₂ absorber 141 One or both of these are used to regulate the breathing gas to a predetermined temperature and/or humidity.

For example, the reaction of the soda-lime _CO2 absorber 141 can be used to humidify high flow gases. A switch (mechanical, electronic, or other) may be employed in the respiratory device to switch the _CO2 absorber 141 between anesthesia ventilation mode and high flow mode. Additionally, the sodium-calcium geometry can be adjusted to vary humidification levels and increase humidity to achieve appropriate levels for high-flow respiratory support. Additionally/alternatively, the amount of _CO2 provided to the soda-calc can be adjusted to increase reaction with the soda-calc and thereby increase humidity. Accordingly, the _CO2 absorber 141 may be employed in a second mode (eg, high flow mode) of the respiratory device 100 to provide additional humidification of the airflow, as shown in Figure 57.

The two operating modes shown in Figures 56 and 57 can be controlled by detecting the coupling of the humidification component 450 to the bracket 160. The respiratory device 100 may be configured to detect coupling of the humidification component 450 to the cradle 160 so that the respiratory device 100 can operate in the second mode. As shown in Figure 38, respiratory device 100 may include a sensor 1050 in communication with controller 1010. Sensor 1050 may be configured to detect coupling of humidification component 450 to bracket 160 . The controller 1010 may be configured to process data from the sensor 1050 to distinguish the coupling of the humidification component 450 and the evaporator 150 . The controller 1010 may then communicate with the switching mechanism 1020 to switch between operating modes, for example, between a first mode and a second mode, as shown in FIGS. 56 and 57 .

Sensor 1050 may include electronic and/or mechanical features for detecting coupling. For example, when humidification component 450 is coupled to bracket 160, sensor 1050 may detect changes in electrical characteristics (eg, resistance, capacitance, or inductance) in the circuit. Alternatively, the humidification component 450 may include a machine-readable component associated with the housing 422, such as a radio frequency identification detection (RFID) device that is capable of being detected by the sensor 1050 when the humidification component 450 is coupled to the bracket 160. In other embodiments, the respiratory device may exclude sensor 1050 and instead provide a mechanical arrangement for detecting the coupling, for example, via a lock and key arrangement or the like, as will be understood by those skilled in the art.

advantage

Embodiments of the present disclosure provide configurations that allow for easy interchange between respiratory support via high flow and respiratory support via anesthesia ventilation/anesthetic delivery via the anesthesia machine.

Some embodiments provide a single machine that provides functionality for both high-flow respiratory support and a rebreathing system for delivering anesthesia, which can operate in both high-flow mode and anesthesia machine (rebreathing) mode. Easily convert or switch between. Ideally, this allows the clinician to easily switch between deployment of high-flow respiratory support and rebreathing the system and subsequently inducing/ventilating the patient. This reduces the overall number of parts, simplifies the work environment, and makes it easier for the anesthesiologist to perform the tasks required in procedures involving high-flow treatments as well as the administration of anesthesia.

When switching from rebreathing mode to high flow mode, it is desirable for safety reasons that the transition stops the delivery of gas from the anesthesia machine. Uncontrolled delivery of _O2 outside of the rebreathing system (e.g. when removing the mask from the patient) creates a risk of fire and wastage of anesthetic gas, as well as the inadvertent release of anesthetic gas into the operating environment, which not only Can contaminate high-flow respiratory support gases and affect personal performance in operating environments. Embodiments of the present invention address one or more of these problems.

Also described herein are various embodiments, devices, connectors, assemblies, accessories, devices, and the like for enabling switching between respiratory support modes. Some of these items provide convenience in control mode selection when the user is not at the "machine" by providing switching actuators closer to the patient or clinician. Some embodiments provide automatic selection of operating modes by monitoring characteristics of the gas in the system (eg, gas pressure and _CO2 concentration in exhaled gas). These features not only improve the convenience and operability of systems that provide these modes of respiratory support, but also have the ability to improve patient safety.

Humidification of the respiratory gases delivered during high-flow respiratory support may be important because without humidification the gas may have a drying effect on the airways, leading to injury and other complications. Embodiments of the present disclosure provide a respiratory device that allows humidification of respiratory gases delivered during high flow respiratory support. The respiratory device includes a holder coupleable with a humidification component for regulating the flow of respiratory gas to a predetermined temperature and/or humidity prior to delivery of the respiratory gas to the patient.

Embodiments of the respiratory device may also advantageously provide an interlock mechanism to prevent the humidification component and one or more vaporizers from operating simultaneously. This may desirably prevent the delivery of volatile anesthetics to the patient during high flow respiratory support. Furthermore, the respiratory device may further comprise a switching mechanism configured to enable selective operation of the humidification component and the at least one evaporator. The switching mechanism may be coupled with the interlocking mechanism to provide easy switching and safe transition between the anesthesia ventilation mode and the high flow mode of the respiratory device during medical procedures requiring both forms of respiratory support.

It will be understood that various modifications, additions and/or substitutions may be made to the previously described components without departing from the scope of the invention as defined in the appended claims.

The invention may also be broadly construed to include the parts, elements and features mentioned or indicated, individually or jointly, in the description of this application and any or all combinations of two or more of said parts, elements or features. If in the preceding description integers or components have been cited with known equivalents, these integers are incorporated here as if individually stated.

If any or all of the following terms are used in this specification (including the claims): the plural form of "includes", the singular form of "includes", the passive form of "includes" or the present participle form of "includes" , they shall be construed as specifying the presence of the stated features, integers, steps or components but not excluding the presence of one or more other features, integers, steps or components or groups thereof.

It is to be understood that the following claims are provided by way of example only, and are not intended to limit the scope of future claims. Features may be added to or omitted from the claims at a later time, in order to further define or redefine the invention or inventions.

Claims (54)

1. A multi-lumen assembly for use with a respiratory support system, the multi-lumen assembly having a plurality of conduits comprising:

(a) A first inspiratory conduit having a first conduit inflow end couplable to a first gas outlet of the respiratory support system;

(b) A second inspiratory conduit having a second conduit inflow end couplable to a second gas outlet of the respiratory support system; and

(c) An exhalation tube having an exhalation tube outflow end that is coupleable with an exhalation gas inlet of the respiratory support system.

2. The multi-lumen assembly of claim 1, wherein the first inspiratory conduit has a first conduit outflow end couplable with a first patient interface configured to sealingly engage and direct flow into an airway of a patient.

3. The multi-lumen assembly of claim 1 or claim 2, wherein the second inspiratory conduit has a second conduit outflow end coupleable with a second patient interface configured to direct flow into an airway of a patient and is a non-sealing interface.

4. A multi-lumen assembly according to any one of claims 1 to 3 wherein at least a length of the plurality of conduits is coaxially arranged.

5. The multi-lumen assembly of any one of claims 1-4, comprising a mechanism to maintain at least a length of the plurality of catheters in a set.

6. The multi-lumen assembly of claim 5, wherein the mechanism comprises a webbing disposed between at least a pair of the plurality of conduits at intervals or continuously along at least a length of the plurality of conduits.

7. The multi-lumen assembly of claim 6, wherein the webbing is frangible so as to facilitate separation of at least a length of one or more of the plurality of catheters from the assembly.

8. The multi-lumen assembly of any of claims 5-7, wherein the mechanism comprises a sheath applied around the plurality of catheters.

9. The multi-lumen assembly of claim 8 wherein a portion of the sheath is removable.

10. The multi-lumen assembly of claim 8 or claim 9 wherein the sheath provides a smooth outer surface.

11. The multi-lumen assembly of any of claims 5-7, wherein the mechanism comprises one or more retainers configured to retain two or more of the plurality of catheters in a set.

12. The multi-lumen assembly of claim 11, wherein the retainer is slidable along a length of one or more of the plurality of catheters.

13. The multi-lumen assembly of any of claims 1-12, wherein the first inspiratory conduit is configured to deliver a respiratory gas comprising an anesthetic agent to a patient.

14. The multi-lumen assembly of any of claims 1-13, wherein the exhalation catheter is configured to return exhaled gases from the patient to the respiratory support system.

15. The multi-lumen assembly of any of claims 1-14, wherein the second inspiratory conduit is configured to deliver respiratory gases to a patient at a flow rate of between 20L/min and 90L/min.

16. The multi-lumen assembly of any one of claims 1 to 15, comprising a flow switching mechanism operable to direct a flow of breathing gas into the first or second inspiratory conduit.

17. The multi-lumen assembly of claim 16, wherein the flow switching mechanism is a shunt.

18. A multi-lumen assembly according to claim 16 or claim 17 wherein the flow switching mechanism is operable by a user.

19. The multi-lumen assembly of claim 16 or claim 17, wherein the flow switching mechanism is operably linked to a respiratory support system controller.

20. The multi-lumen assembly of claim 19, wherein the respiratory support system controller controls the respiratory support system to deliver respiratory gas to the multi-lumen assembly in accordance with user operation of the flow switching mechanism.

21. The multi-lumen assembly of claim 19, wherein the respiratory support system controller controls operation of the flow switching mechanism.

22. The multi-lumen assembly of any one of claims 1 to 21, wherein the outflow end of the first inspiratory conduit and the inflow end of the expiratory conduit form a common gas flow path defined by a single gas exchange conduit coupleable with a first patient interface.

23. The multi-lumen assembly of claim 22, wherein the multi-lumen assembly includes a taper to reduce the overall cross-section of the assembly in the region of the single gas exchange conduit.

24. The multi-lumen assembly of any one of claims 1 to 23, wherein the multi-lumen assembly comprises a patient-end connector for:

(a) Coupling an outflow end of the first inspiratory conduit with a first patient interface; and

(b) An outflow end of the second inspiratory conduit is coupled to a second patient interface.

25. The multi-lumen assembly of claim 24, wherein the patient-side connector comprises a switching element operable to switch the connector between a first mode of operation in which the connector directs breathing gas to the first patient interface and a second mode of operation in which the connector directs breathing gas to the second patient interface.

26. The multi-lumen assembly of claim 25, wherein the switching element is operably couplable with a respiratory support system controller.

27. The multi-lumen assembly of claim 25, wherein the switching element is operable by a user, and the controller controls operation of the respiratory support system according to user operation of the switching element.

28. A multi-lumen assembly according to claim 26 or claim 27 wherein the respiratory support system controller controls operation of the switching element.

29. The multi-lumen assembly of any one of claims 1 to 28, further comprising a gas sampling conduit for monitoring one or more characteristics of the gas.

30. The multi-lumen assembly of claim 29, wherein the characteristic is used by a respiratory support system controller to determine whether the connector is delivering respiratory gas to a patient in the first inspiratory conduit or in the second inspiratory conduit, and wherein the controller operates the respiratory support system to automatically select a corresponding mode of operation of the respiratory support system.

31. A system for delivering respiratory gases to a patient, the system comprising:

(a) A flow source configured to provide a flow of gas through the system in a gas delivery circuit; and

(b) A gas delivery circuit comprising an inspiratory gas flow path and an expiratory gas flow path,

the system is configured to switch between a first mode and a second mode, wherein:

In the first mode, the system is operable to deliver respiratory gas to a patient via the inspiratory gas flow path and a first patient interface in fluid communication with the inspiratory flow path, and to deliver expiratory gas from the patient via the expiratory gas flow path and a second patient interface in fluid communication with the expiratory gas flow path, the respiratory gas comprising a first flow parameter; and is also provided with

In the second mode, the system is operable to deliver respiratory gas to the patient via the inspiratory gas flow path and a third patient interface, the respiratory gas comprising a second flow parameter.

32. The system of claim 31, wherein the first flow parameter is different from the second flow parameter.

33. The system of claim 31 or 32, wherein the first flow parameter comprises a first flow rate and the second flow parameter comprises a second flow rate, wherein the first flow rate is less than the second flow rate.

34. The system of any of claims 31-33, wherein the first flow rate is less than 15L/min and the second flow rate is greater than 15L/min.

35. The system of claim 34, wherein the second flow rate is in a range between about 20L/min and about 90L/min, optionally in a range between about 40L/min and about 70L/min.

36. The system of any one of claims 31 to 35, wherein the first patient interface comprises a non-sealing patient interface, optionally a nasal cannula, and the second patient interface comprises a sealing patient interface, optionally a mask.

37. The system of any one of claims 31 to 36, wherein the third patient interface comprises a non-sealing patient interface, optionally a nasal cannula.

38. The system of any one of claims 31 to 37, wherein the exhalation flow path is inoperable in the second mode.

39. The system of any of claims 31 to 38, wherein the first and third patient interfaces are the same.

40. The system of claim 39, wherein the system is in the first mode when the first and second patient interfaces are applied to a patient simultaneously, and the system is in the second mode when only the third patient interface is applied to a patient.

41. The system of claim 40, wherein the first and third patient interfaces comprise non-sealing nasal cannulas and the second patient interface comprises a sealing mask, and wherein the system is in the first mode when the nasal cannulas and mask are applied to a patient and in the second mode when only the nasal cannulas are applied to a patient.

42. The system of claim 41, wherein the mask is configured to seal over the nasal cannula and to seal with a patient.

43. The system of any one of claims 31 to 42, comprising a third mode and a fourth patient interface, wherein the system is configured to deliver respiratory gas to a patient via the inspiratory gas flow path and the fourth patient interface, and to deliver expiratory gas from the patient via the expiratory gas flow path and the fourth patient interface, the respiratory gas comprising a third flow parameter.

44. The system of claim 43, wherein the fourth patient interface comprises a sealed patient interface, optionally an invasive patient interface, and optionally an endotracheal tube.

45. The system of any one of claims 31 to 44, wherein the first flow parameter comprises a pressure and/or a volume parameter.

46. The system of claim 43 or 44 or claim 45 when dependent on claim 43 or 44, wherein the third flow parameter comprises one or more of a flow, pressure, or volume parameter.

47. The system of claim 45 or 46, wherein the system is configured to control delivery of breathing gas to the patient based on pressure and/or volume.

48. The system of any one of claims 31-47, comprising an inspiratory conduit defining at least a portion of the inspiratory gas flow path and an expiratory conduit defining at least a portion of the expiratory gas flow path, and a common connector disposed at ends of the inspiratory conduit and the expiratory conduit, the common connector configured to connect to one or more patient interfaces.

49. The system of any one of claims 31 to 48, comprising a controller in communication with the flow source and one or more of a sensor and an input interface in communication with the controller to provide input to the controller to control the flow source to provide a flow of breathing gas in the first mode or the second mode.

50. A system according to claim 49 when dependent on any of claims 43 to 47, wherein the sensor and/or input interface is configured to provide input to the controller to control the flow source to provide a flow of breathing gas in the third mode.

51. The system of any one of claims 31 to 50, comprising a humidifier, wherein the breathing gas is heated and humidified by the humidifier in the second mode before the breathing gas is delivered to the patient.

52. The system of any one of claims 31 to 50, wherein exhaled gas from the patient is returned to the inspiratory gas flow path in the first mode.

53. The system of any one of claims 31 to 47 or claims 48 to 52 when dependent on any one of claims 31 to 47, wherein in the third mode exhaled gas from the patient is returned to the inhaled gas flow path.

54. The system of claim 52 or 53, comprising CO ₂ A remover of the CO ₂ A remover is configured to remove CO from the exhaled gas before the exhaled gas is returned to the inhaled gas flow path ₂ 。