DE102023101161A1 - Inhalation anesthesia device for improved interactive anesthesia - Google Patents

Abstract

The present invention relates to an inhalation anesthesia device for the interactive administration of at least one anesthetic gas to a patient, at least comprising: a) an anesthetic gas circuit comprising an anesthetic gas reservoir, an anesthetic gas supply line having at least one anesthetic gas control valve, an anesthetic gas applicator and an anesthetic gas flow measuring device, wherein the anesthetic gas flow measuring device is configured to detect the anesthetic gas flow flowing into and out of the patient via the anesthetic gas applicator as a function of time; b) a display unit; c) a control unit, wherein the control unit is configured to receive the anesthetic gas flow detected via the anesthetic gas flow measuring device and to control the display unit as a function of the measured anesthetic gas flow.

Description

1. a) einen Narkosegaskreislauf, umfassend einen Narkosegasspeicher, eine Narkosegaszufuhrleitung aufweisend mindestens ein Narkosegasregelventil, einen Narkosegasapplikator und eine Narkosegasflussmessvorrichtung, wobei die Narkosegasflussmessvorrichtung dazu eingerichtet den über den Narkosegasapplikator in den Patienten ein- und ausströmenden Narkosegasfluss als Funktion der Zeit zu detektieren;
2. b) eine Anzeigeeinheit;
3. c) eine Steuereinheit, wobei die Steuereinheit dazu eingerichtet ist den über die Narkosegasflussmessvorrichtung detektierten Narkosegasfluss zu empfangen und die Anzeigeeinheit als Funktion des gemessenen Narkosegasflusses zu steuern.

The present invention relates to an inhalation anesthesia device for the interactive administration of at least one anesthetic gas to a patient, comprising at least:

1. a) an anesthetic gas circuit comprising an anesthetic gas reservoir, an anesthetic gas supply line having at least one anesthetic gas control valve, an anesthetic gas applicator and an anesthetic gas flow measuring device, wherein the anesthetic gas flow measuring device is configured to detect the anesthetic gas flow flowing into and out of the patient via the anesthetic gas applicator as a function of time;
2. (b) a display unit;
3. c) a control unit, wherein the control unit is configured to receive the anesthetic gas flow detected via the anesthetic gas flow measuring device and to control the display unit as a function of the measured anesthetic gas flow.

Serious surgical interventions or examinations on the human or animal body are usually carried out under local or systemic anesthesia. The anesthesia immobilizes the patient's body and temporarily and/or locally eliminates the sensation of pain. While local anesthesia can usually be carried out with much less effort, full anesthesia requires the systemic administration of an anesthetic. The agent can either be administered intravenously, which requires IV access via a cannula or needle, or the patient can be exposed to an inhalation gas for a period of around 30-50 seconds. Both procedures are state-of-the-art and are used more than a million times a day worldwide. The procedures are usually extremely straightforward in cases where the patient is calm and relaxed and cooperative. However, anesthetizing agitated patients can lead to complications because inserting a needle or putting on an anesthetic mask can lead to a fear reaction, possibly with physical resistance from the patient. To avoid these fear reactions, anesthetists have currently worked with distraction strategies before induction of anesthesia. These distraction strategies, for example in the form of conversation, are particularly useful and indicated for children, as distraction increases the children's well-being and can reduce stress symptoms. In everyday clinical practice, however, it has been shown that distraction strategies only work well as long as nobody is touching the child or the child is still feeling unwell. As a rule, as soon as you try to apply a needle, the distraction breaks down and the desired effect is no longer achieved. An improved procedure or improved technical support devices should therefore be used where the distraction works continuously and more safely until the patient falls asleep.

The patent literature also contains a wide variety of methods and devices for inducing anesthesia via a stream of anesthetic gas.

For example, the US2015114388A1 an adapter for use with an anesthesia face mask prior to a medical procedure, such as surgery on children. The adapter includes a housing having a cooperating structured input port at its proximal end that facilitates connection of the housing to an opening of the anesthesia face mask structured to receive inhalation anesthetics or other gases. It further includes a sensor, which may be a microphone or flow meter, disposed on or at least partially within the housing and structured to receive control commands from the user, and a computing device in communication relationship with the sensor and structured to present interactive media to the user. The computing device is structured to appropriately alter the interactive media in accordance with control commands given by a user. Additionally, the present invention is directed to a method of using the adapter described herein.

In another document, the US2002 120 207A1 , a system is disclosed for measuring the respiratory function of living organisms. In particular, signals indicative of the change in lung volume, defined as the active and passive work required to breathe, and the airflow through the respiratory system of the living organism are obtained and processed as waveforms to provide a signal indicative of respiratory restriction. The methods include measuring clinical forms of airway obstruction, airway reactivity and lung volume and these can be used to continuously or intermittently monitor patients with impaired respiratory function.

Furthermore, the US 2008 066 739 A1 Systems and methods for delivering a medication to the respiratory system of a patient. The medication is delivered at a positive pressure relative to the atmospheric pressure. In particular, the drugs are delivered to the respiratory system of a patient capable of unassisted breathing. The systems and methods of the present disclosure introduce a drug, available in a variety of forms, into the airstream in a controlled manner in aerosolized, nebulized or vaporized form.

Such solutions known from the state of the art can offer further potential for improvement, in particular with regard to distraction and anesthesia efficiency, as well as the patent compatibility and acceptance of the device components used.

It is therefore the object of the present invention to at least partially overcome the disadvantages known from the prior art. It is in particular the object of the present invention to provide a device which is able to induce controlled anesthesia with a high level of intrinsic acceptance, reproducibly and reliably, even in difficult patient groups, such as children.

The problem is solved by the features of the independent claim, directed to the device according to the invention. Preferred embodiments of the invention are specified in the subclaims, in the description or in the figures, whereby further features described or shown in the subclaims or in the description or in the figures can represent an object of the invention individually or in any combination, as long as the context does not clearly indicate the opposite.

1. a) einen Narkosegaskreislauf, umfassend einen Narkosegasspeicher, eine Narkosegaszufuhrleitung aufweisend mindestens ein Narkosegasregelventil, einen Narkosegasapplikator und eine Narkosegasflussmessvorrichtung, wobei die Narkosegasflussmessvorrichtung dazu eingerichtet den über den Narkosegasapplikator in den Patienten ein- und ausströmenden Narkosegasfluss als Funktion der Zeit zu detektieren;
2. b) eine Anzeigeeinheit;
3. c) eine Steuereinheit, wobei die Steuereinheit dazu eingerichtet ist den über die Narkosegasflussmessvorrichtung detektierten Narkosegasfluss zu empfangen und die Anzeigeeinheit als Funktion des gemessenen Narkosegasflusses zu steuern.

According to the invention, there is therefore provided an inhalation anesthesia device for the interactive administration of at least one anesthetic gas to a patient, the inhalation anesthesia device comprising at least:

1. a) an anesthetic gas circuit comprising an anesthetic gas reservoir, an anesthetic gas supply line having at least one anesthetic gas control valve, an anesthetic gas applicator and an anesthetic gas flow measuring device, wherein the anesthetic gas flow measuring device is configured to detect the anesthetic gas flow flowing into and out of the patient via the anesthetic gas applicator as a function of time;
2. (b) a display unit;
3. c) a control unit, wherein the control unit is configured to receive the anesthetic gas flow detected via the anesthetic gas flow measuring device and to control the display unit as a function of the measured anesthetic gas flow.

Surprisingly, it was found that even very challenging patient groups can be anesthetized reliably and without causing great stress using the above-mentioned device. This is particularly true for anesthetizing children, which can be very challenging for particularly anxious children. In these cases, it is not indicated that intravenous anesthesia is administered, as needles usually cause a much higher stress potential. In these cases, it is particularly suitable for anesthesia to be induced using an anesthetic gas, whereby the child's interaction with the display unit can contribute to a particularly strong distraction of the child. The display unit gives the child concrete and direct feedback on their own breathing rhythm, which is recorded via the anesthetic gas applicator and the anesthetic gas flow measuring device and passed on to the control unit. The device is particularly designed to implement "gamification strategies" in the context of anesthesia. Almost every child between the ages of 2 and 8 is more or less familiar with electronic media these days. The older the child, the more used to electronic games they are. Even primary schools have started using electronic learning tools in the Covid or post-Covid period. The device according to the invention can be used to exploit children's intrinsic curiosity and encourage them to play a "game". To interact with the display, the children or patients must breathe through a regular anesthesia circuit. The intensity of each breath is translated into an electronic pulse by the anesthetic gas flow measuring device. This pulse is transmitted to the display unit and the child can, for example, navigate a figure through a maze or other age-appropriate game. While the child is playing this game, the anesthetic gas circuit administers an inhaled anesthetic gas (sevoflurane), and the child breathes evenly and purposefully as a function of the display and falls asleep faster and without stress. In the best case, a very even breathing profile is achieved and the physiological effects induced by the anesthesia are not even noticed. The device can therefore directly reduce the patient's stress level during anesthesia and control or at least even out the anesthetic gas uptake.

Inhalation anesthesia device for the interactive administration of at least one anesthetic gas to a patient. Patients in this sense can be humans or animals. The patient is administered a gas via the respiratory tract, which ches is able to influence the patient's consciousness and pain perception. The anesthetic gases used in medicine for these purposes are known to those skilled in the art. In contrast to conventional administration, according to the invention the device influences the patient's breathing behavior so that the patient is encouraged to follow a certain breathing pattern. In this respect, the patient is encouraged to interact via the device, which leads to certain inhalation or exhalation movements being initiated and ultimately carried out. The interaction therefore takes place via the influence of breathing on the representation of a display unit. The device can preferably be used to anesthetize children aged less than or equal to 12 years, furthermore preferably less than or equal to 8 years, and furthermore preferably less than or equal to 6 years.

The inhalation anesthesia device comprises at least a) an anesthetic gas circuit, comprising an anesthetic gas reservoir, an anesthetic gas supply line having at least one anesthetic gas control valve, an anesthetic gas applicator and an anesthetic gas flow measuring device, wherein the anesthetic gas flow measuring device is set up to detect the anesthetic gas flow flowing into and out of the patient via the anesthetic gas applicator as a function of time. The anesthetic device can therefore initially comprise a conventional anesthetic gas circuit. The anesthetic gas circuit can have at least one reservoir for the anesthetic gas. The usual reservoirs in the form of gas bottles can be used. The anesthetic gas is taken from the anesthetic gas reservoir via a line or a hose and reaches an anesthetic gas applicator. The applicator can, for example, be designed in the form of a mask that covers the patient's nose and mouth. At least one control valve is also arranged along the anesthetic gas supply line, by means of which the amount of gas from the reservoir into the applicator can be controlled. In addition to these usual components for providing the anesthetic gas, the device also includes a measuring device. The measuring device measures the amount of anesthetic gas that the patient absorbs as a function of time.

The flow of anesthetic gas that flows into and out of the patient is determined. The signal is therefore proportional to the amount of anesthetic gas absorbed per unit of time.

The inhalation anesthesia device also comprises b) a display unit. Possible display units are, for example, screens, monitors or smartphone screens. The display units are set up so that moving images or animations can be shown on them. The images or animations can, for example, be part of a game. For example, running and/or jumping men or animals can be used as moving parts of an animation.

The inhalation anesthesia device also comprises c) a control unit, wherein the control unit is configured to receive the anesthetic gas flow detected by the anesthetic gas flow measuring device and to control the display unit as a function of the measured anesthetic gas flow. The anesthetic gas supply results from the patient's breathing pattern. The effective anesthetic gas supply results from both the concentration of anesthetic gas in the supplied breathing air and the total amount of air taken in. If the measurement of the anesthetic gas flow measuring device shows that the respiratory rate is too low for efficient and rapid anesthesia, the patient can be encouraged via the display unit to increase his respiratory rate. This can be done, for example, by providing a sequence on the display unit which encourages the patient to breathe more frequently. The respiratory rate generates direct feedback from the animation on the screen. However, it is also possible that the frequency is actually sufficient for anesthesia, but the depth of the breaths is insufficient. In this case, an animation sequence can be provided which encourages the patient to breathe deeper. In this respect, the amount of anesthetic gas absorbed via the anesthetic gas flow measuring device influences the representations on the display unit and vice versa. The anesthetic gas flow measuring device is set up to detect the amount of anesthetic gas as a function of time in the patient's absorbed breathing gas. The control unit can, for example, be designed in the form of a computer, whereby the computer receives the electrical signals from the measuring device and, as a function of these signals, controls the animation sequences on the display unit. The control unit can also, for example, be in the form of a smartphone, whereby the electrical signals from the measuring device are recorded, stored if necessary, and influence what happens in an app on the smartphone. In this respect, what happens on the screen is indirectly controlled via the programming of the app in the smartphone's memory as a function of the patient's breathing.

In a preferred embodiment of the device, the anesthetic gas flow measuring device can be set up to measure the volume flow of the anesthetic gas. For the most efficient measurement and progression of the anesthesia, it has proven to be particularly advantageous that the measuring device detects the volume flow of the anesthetic gas from the anesthetic gas storage tank to the patient. The detection of the volume flow of anesthetic gas takes place as a function of time. By measuring the anesthetic gas volume flow, the integral uptake of anesthetic gas can be determined and thus, theoretically, the degree of anesthesia achieved by the patient can be obtained. Determining the volume flow can be significantly more advantageous than, for example, only determining the concentration of the anesthetic gas in the total breath taken in by the patient during anesthesia. However, it is also alternatively possible to measure or detect the total volume flow of the respiratory gas into the applicator and also the amount of gas released per time from the storage tank. The concentration of the anesthetic gas in the total flow can then be determined from the two quantities. In this embodiment, the anesthetic gas flow meter can be suitable for detecting the volume flow of the total gas quantity.

In a further preferred embodiment of the device, the anesthetic gas flow measuring device can comprise at least one ultrasonic gas flow meter. In particular, ultrasonic gas flow meters have proven to be particularly suitable for rapid and specific detection of the anesthetic gas quantities absorbed. The ultrasonic gas flow meters are able to react very quickly to possible changes in the respiratory gas composition and to display these, so that even if the patient's breathing profile is irregular, a reliable value for the amount of anesthetic gas absorbed can be detected and passed on to the control unit. The detection within the scope of the anesthetic gas flow measuring device can be carried out, for example, using a highly accurate ultrasonic time-of-flight method. If necessary, the ultrasonic sensor can be supplemented with another sensor that records the flow direction of the respiratory gas. In a preferred embodiment, this can help to ensure that only the inhaled part of the anesthetic gas is used to control the display unit. It is also possible for the ultrasonic gas flow meter to detect the total gas flow.

In a further preferred aspect of the device, the ultrasonic gas flow meter can be arranged on the anesthetic gas supply line from the outside. The flow meter can therefore preferably be strapped or clamped onto the breathing tube of the anesthetic circuit from the outside (clamp-on technology). It is not necessary to separate the tube and no pressure losses occur. By arranging the flow meter on the anesthetic gas supply line, no additional sealing surfaces or dead volumes arise, in contrast to an arrangement inside the supply line. This can make cleaning the device easier and in particular significantly reduce the risk of unwanted germs entering the anesthetic gas circuit. Alternatively, the ultrasonic gas flow meter or the anesthetic gas flow measuring device can be arranged on the anesthetic gas applicator from the outside.

According to a preferred characteristic, the device can have a recording unit, wherein the recording unit is set up to detect relative position changes of the patient's upper body, to forward the current relative position of the patient's upper body to the control unit, and the control unit is set up to control the display unit as a function of the relative position of the patient's upper body. The recording unit can therefore determine, for example, the vertical position of the patient's chest. In addition to detecting the volume flow of anesthetic gas, the patient's inhalation and exhalation can be tracked using an independent method and used as a control variable for what happens on the display unit. However, it is also possible to establish a cross-correlation between the relative position of the patient's upper body and the volume flow measurement of the anesthetic gas in the anesthesia circuit and to use a common variable to control the display unit. The latter design can enable more reliable control and monitoring of the anesthesia process, particularly in cases where the patient is hyperventilating, for example. The additional recording of the patient's position changes can also help the display unit to give the patient feedback that he should behave more calmly, in the sense of fewer or smaller changes in the position of the upper body. The device according to the invention can therefore not only interactively influence the patient's breathing behavior, but also interactively influence the patient's movement pattern.

According to a preferred characteristic of the device, the recording unit can be arranged on the display unit. For particularly precise recording of the patient during the anesthesia process, it has proven to be particularly advantageous that the recording unit is arranged on the display unit. This is particularly advantageous if the display unit can be placed directly in front of the patient. A particularly preferred embodiment is that a smartphone is used as the display unit, with the selfie camera of the smartphone phones can be used as a recording unit for detecting and monitoring the patient.

In a further preferred embodiment of the device, the anesthesia device can have a pressure sensor, wherein the pressure sensor can be arranged on the palm of the patient's hand and is designed to detect the pressure exerted by the hand or by several fingers and to forward it to the control unit. For particularly efficient monitoring of the anesthesia process, it has proven to be particularly advantageous that, in addition to detecting the anesthetic gas volume, other, alternative parameters are also used for monitoring and influencing. A complementary and very useful parameter in this context is the hand's ability to coordinate. The ability to react to certain content on the display unit can be measured and induced using a pressure sensor placed in the hand. If there are measurable delays in the reaction, a model can be created that predicts the progression of the anesthesia in certain patient groups. The model can be made more robust and less prone to errors by including another independent parameter, in this case the hand's ability to react.

In a preferred aspect of the device, the control device can be set up to regulate the anesthetic gas flow through the anesthetic gas control valve. In order to optimize the amount of anesthetic gas delivered to anesthetize a specific patient, it has proven particularly advantageous for the control device to act directly on the anesthetic gas control valve. The patient is encouraged to take in anesthetic gas evenly and efficiently across the entire device, and the measured amount of anesthetic gas taken in can be used to reduce the total concentration in the breathing air from a certain point in time, so that a large excess of anesthetic gas is not unnecessarily delivered and taken in by the patient.

In a further preferred embodiment of the device, the display unit can be set up to output a haptic or acoustic signal. For further interaction with the patient, it has proven particularly advantageous that the display unit can interact with the patient via other signal options. In addition to the visual signals, acoustic signals can also contribute to reinforcing the desired breathing pattern. This can be done, for example, by means of a voice output in the sense of "well done" or a short supporting jingle.

In a further preferred embodiment of the device, the anesthesia device can have an optical detection unit, wherein the optical detection unit is set up to detect the eyelid and/or eye movements of the patient. In addition to the pure measurement of the anesthetic gas, it has also proven to be very positive that the patient's eye movements during the anesthesia can also be detected via an optical detection unit. The optical detection unit can correspond to the recording unit. The patient's eye movements change as a function of the progression of the anesthesia and a more robust model can be generated based on the amount of anesthetic gas absorbed and the eye functions, which is much more meaningful for the anesthetic effect achieved than the use of just one parameter. Depending on the common model, the control unit can, for example, select a different display sequence that is more appropriate for anesthesia that is already advanced than for anesthesia that is just beginning. Furthermore, this independent parameter can be used to compare the amount of anesthetic gas taken in and in this way detect irregularities or an unusual reaction from the patient to the selected anesthesia. This additional parameter provides another control variable which is highly significant for the progression of the anesthesia. Rapid eye movements indicate a specific anesthesia status and this status can also be used to either output an acoustic or optical signal, regulate the anesthetic gas flow or change the animation on the screen. In this preferred embodiment, the display unit can preferably be controlled via breathing, the pressure sensor and the frequency of the eye movements. Control of the display or the anesthetic gas flow itself as a function of these three variables can be more specifically tailored to the desired breathing pattern to be induced in the patient. In particular, this embodiment can also include the interactive promotion of not only breathing as such, but also specific breathing patterns in frequency and depth. The higher number of parameters taken into account can promote more specific, desired breathing, which can be individually adapted to the patient group.

Further advantages and advantageous embodiments of the objects according to the invention are illustrated by the figure. It should be noted that the figure is only descriptive and is not intended to limit the invention in any way.

The 1 shows schematically the structure of a device according to the invention for administering an anesthetic gas. The anesthetic circuit comprises the anesthetic gas reservoir 1, for example in the form of an anesthetic gas cartridge or an anesthetic gas bottle. The anesthetic gas reservoir 1 is connected to the anesthetic gas applicator 5 via an anesthetic gas supply line 2. The anesthetic gas applicator 5 can be in the form of a mask which is placed over the patient's mouth and nose. The amount of anesthetic gas released from the anesthetic gas reservoir 1 can be regulated via the anesthetic gas control valve 3. The anesthetic gas flow is detected via the anesthetic gas flow measuring device 4. The anesthetic gas flow measuring device 4 can be in the form of an ultrasonic sensor 4 attached to the supply line or to the applicator 5, for example. The device also has a display unit 6 which can preferably be placed directly in front of the patient's face. The display unit 6 is set up to display sequences and animations which are output via a control unit 7. For this purpose, the control unit 7 receives the measurement signals from the anesthetic gas flow measuring device 4. These signals from the anesthetic gas flow measuring device 4 are of course dependent on the patient's breathing behavior. If the patient inhales heavily, a high temporal anesthetic gas flow is detected via the anesthetic gas flow measuring device 4. If the patient does not breathe at all during the time interval, no anesthetic gas flow is detected via the anesthetic gas flow measuring device 4. The control device 7 can, for example, be designed in the form of a smartphone which has an app in its memory which can, for example, control a jump and run game. In this case, the character in the jump and run game is controlled by the patient's breathing. This takes place indirectly via the detected anesthetic gas flow. As a function of the controlled screen display, the patient is specifically encouraged to breathe either more frequently or more deeply or less or more shallowly to absorb more or less anesthetic gas. In this way, the most efficient way of inducing anesthesia can be controlled interactively with the help of the patient himself. The display unit 6 can also have a recording device 8 which can detect the position of the patient's upper body or the patient's eye or eyelid movement. These movements can be passed on to the control unit 7 and incorporated into the control of the display unit 6. The device can also have a pressure sensor 9 which reacts to the patient's finger and hand movements. This additional input can be used to control the flow of anesthetic gas via the anesthetic gas control valve 3. It is also possible, however, for the measured values of the pressure sensor 9 to be passed on to the control unit 7 and for the control unit 7 to adapt the display on the display unit 6 as a function of the progression of the anesthesia and the interactive participation of the patient.

QUOTES INCLUDED IN THE DESCRIPTION

This list of documents listed by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions.

Cited patent literature

• US 2015114388 A1 [0004]
• US 2002120207 A1 [0005]
• US 2008066739 A1 [0006]

Claims (10)

Inhalation anesthesia device for the interactive administration of at least one anesthetic gas to a patient, comprising at least: a) an anesthetic gas circuit comprising an anesthetic gas reservoir (1), an anesthetic gas supply line (2) having at least one anesthetic gas control valve (3), an anesthetic gas applicator (5) and an anesthetic gas flow measuring device (4), wherein the anesthetic gas flow measuring device (4) is configured to detect the anesthetic gas flow flowing into and out of the patient via the anesthetic gas applicator (5) as a function of time; b) a display unit (6); c) a control unit (7), wherein the control unit (7) is configured to receive the anesthetic gas flow detected via the anesthetic gas flow measuring device (4) and to control the display unit (6) as a function of the measured anesthetic gas flow. Device according to Claim 1 , wherein the anesthetic gas flow measuring device (4) is adapted to measure the volume flow of the anesthetic gas. Device according to one of the preceding claims, wherein the anesthetic gas flow measuring device (4) comprises at least one ultrasonic gas flow meter. Device according to Claim 3 , wherein the ultrasonic gas flow meter is arranged externally on the anesthetic gas supply line (2). Device according to one of the preceding claims, wherein the device has a recording unit, wherein the recording unit is configured to detect relative position changes of the patient's upper body, to forward the current relative position of the patient's upper body to the control unit (7), and the control unit (7) is configured to control the display unit as a function of the relative position of the patient's upper body. Device according to Claim 5 , wherein the recording unit is arranged on the display unit (6). Device according to one of the preceding claims, wherein the anesthesia device has a pressure sensor (9), wherein the pressure sensor (9) can be arranged on the palm of the patient's hand and is designed to detect the pressure exerted by the hand or by several fingers and to transmit it to the control unit (7). Device according to one of the preceding claims, wherein the control device (7) is adapted to regulate the anesthetic gas flow through the anesthetic gas control valve (3). Device according to one of the preceding claims, wherein the display unit (6) is adapted to output a haptic or an acoustic signal. Device according to one of the preceding claims, wherein the anesthesia device has an optical detection unit, wherein the optical detection unit is configured to detect the eyelid and/or eye movements of the patient.

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