CN119908666B - A gastric reflux prediction device for patients undergoing mechanical ventilation - Google Patents
A gastric reflux prediction device for patients undergoing mechanical ventilationInfo
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- CN119908666B CN119908666B CN202510042752.2A CN202510042752A CN119908666B CN 119908666 B CN119908666 B CN 119908666B CN 202510042752 A CN202510042752 A CN 202510042752A CN 119908666 B CN119908666 B CN 119908666B
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Abstract
本发明涉及一种用于机械通气患者的胃液反流预测装置，属于医疗设备技术领域。该胃液反流预测装置包括：第一pH值传感器，用于测量患者的口腔或会厌区域的pH值；第二pH值传感器，用于测量气管插管上的扩张气囊所在区域的pH值；分析单元，用于接收上述pH值传感器采集的pH值，并对其进行分析处理，分析单元被配置为：根据第一pH值传感器提供的pH值来确定患者口腔或会厌区域的pH值随时间的变化情况，根据第二pH值传感器提供的pH值来确定扩张气囊上端的pH值随时间的变化情况，其中，气管插管上的扩张气囊能够被设置于患者气管内并与气管壁接触。
The present invention relates to a gastric reflux prediction device for mechanically ventilated patients, belonging to the technical field of medical equipment. The gastric reflux prediction device comprises: a first pH sensor for measuring the pH value of the patient's oral cavity or epiglottis; a second pH sensor for measuring the pH value of the area where the dilation balloon on the endotracheal tube is located; and an analysis unit for receiving and analyzing the pH values collected by the pH sensors. The analysis unit is configured to determine how the pH value of the patient's oral cavity or epiglottis changes over time based on the pH value provided by the first pH sensor, and to determine how the pH value at the upper end of the dilation balloon changes over time based on the pH value provided by the second pH sensor. The dilation balloon on the endotracheal tube can be positioned within the patient's trachea and in contact with the tracheal wall.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a gastric reflux prediction device for a mechanically ventilated patient.
Background
Mechanical ventilation refers to assisting or replacing the spontaneous respiratory function of a patient through the use of mechanical devices. When a patient fails to maintain adequate gas exchange for various reasons (e.g., acute respiratory distress syndrome, acute exacerbation of chronic obstructive pulmonary disease, neuromuscular disease, severe trauma or postoperative recovery, etc.), mechanical ventilation may provide the necessary support, ensure adequate oxygen transport into the blood, and effectively expel carbon dioxide. This process not only helps to stabilize the patient's respiratory state, but can also fight for time to treat the underlying cause.
In an intensive care setting, mechanically ventilated patients are often at risk of a series of complications, one of which is regurgitation of gastric juice. Since these patients are often sedated or comatose and require prolonged bed rest, they are more prone to reflux of gastric contents due to the effects of mechanical ventilation itself. This condition not only increases the risk of aspiration, possibly leading to serious complications such as aspiration pneumonia, but also may affect the effect of mechanical ventilation and the rehabilitation process of the patient.
Mechanical ventilation maintains the patient's respiratory function by manual means, and when the endotracheal tube is inserted, an inflatable balloon is placed to seal the airway, to ensure that gas does not leak and prevent foreign matter from entering the lower airway. However, gastric reflux, even so, remains a potential problem. Gastric juice has strong acidity and may contain food particles, bacteria and other harmful substances. If these substances are inhaled into the lungs, chemical injury may be caused, leading to alveolar inflammatory reactions, which in turn progress to aspiration pneumonia, one of the common types of infection in intensive care units, significantly increasing mortality and hospitalization time of patients.
CN112169122a discloses a length-adjustable back flow early warning oropharynx, nasopharynx air vent, including interior sleeve pipe, outer tube, impeller, color development system and alarm system, interior sleeve pipe's one end sets up the inside of outer tube and follow the inside wall of outer tube can be reciprocating motion, the other end with the impeller is connected, color development system sets up interior sleeve pipe's inside wall and on the inside wall of impeller, alarm system's one end passes impeller and interior sleeve pipe set up on the terminal surface that interior sleeve pipe kept away from impeller one end, the other end is installed on the lateral wall of impeller.
CN110478584a discloses an integrated intelligent laryngeal mask with pH and temperature monitoring function, comprising a mask body, a mask bag and a vent pipe cavity, wherein the mask body is provided with a linear groove, a signal transmission line pipe cavity and a drainage pipe cavity are arranged in the mask body and are respectively communicated with a temperature sensor probe microcavity on the mask body and a pH sensor probe microcavity and a drainage port arranged in the linear groove, one ends of a pH sensor signal transmission line and a temperature sensor signal transmission line arranged in the signal transmission line pipe cavity are respectively connected to a miniature pH sensor probe and a miniature temperature sensor probe, and the other ends are respectively connected to a multifunctional signal processing display.
In the intensive care of mechanically ventilated patients, gastric reflux and its attendant aspiration risk constitute a significant and urgent problem to be solved. One of the current clinical challenges is that it is difficult to achieve real-time monitoring of gastric reflux. Traditional monitoring methods often rely on post-sampling inspection methods, which are not only time-consuming, but also fail to provide immediate data feedback, resulting in medical personnel being able to learn the results only after a period of time has elapsed. This delay makes timely precaution or intervention difficult, thereby increasing the risk of serious complications in patients due to aspiration, such as aspiration pneumonia, acute Respiratory Distress Syndrome (ARDS), etc. Another important problem is the lack of ability of the prior art to early alert of gastric reflux. Since the occurrence of regurgitation of gastric juice is generally abrupt and without obvious predictors, especially in the case of sedated or comatose patients, the protective reflex is reduced or lost, which makes it difficult to find in advance and prevent the occurrence of aspiration with conventional monitoring means. Without an effective early warning mechanism, medical personnel can only passively cope with the reflux event which has occurred, rather than actively prevent the reflux event, which constitutes a potential threat to the safety of patients.
Furthermore, since the applicant has studied numerous documents and patents on the one hand, and since the applicant has made the present invention, the text is not to be limited to all details and matters of detail, but this is by no means the present invention does not feature these prior art features, but rather the present invention has features of all prior art, and the applicant has remained in the background art to which this invention pertains.
Disclosure of Invention
In view of the shortcomings of the prior art, the present invention provides a gastric reflux prediction device for a mechanically ventilated patient, which solves at least some of the above-mentioned problems.
The invention discloses a gastric reflux prediction device for a mechanically ventilated patient, which comprises a first pH value sensor, a second pH value sensor and an analysis unit, wherein the first pH value sensor is used for measuring the pH value of an oral cavity or an epiglottis area of the patient, the second pH value sensor is used for measuring the pH value of an area where an expanding air bag on an trachea cannula is located, and the analysis unit is used for receiving the pH value acquired by the pH value sensor and analyzing the pH value. The analysis unit is configured to determine a change in pH over time of the patient's mouth or epiglottis region based on the pH provided by the first pH sensor and to determine a change in pH over time of the upper end of the dilation balloon based on the pH provided by the second pH sensor, wherein the dilation balloon on the endotracheal tube is capable of being positioned within the patient's trachea and in contact with the tracheal wall.
According to the gastric reflux prediction device, the first pH value sensor and the second pH value sensor are introduced to respectively measure the pH values of the oral cavity or the epiglottis area of a patient and the area where the expansion air sac on the tracheal intubation is located, and the data are processed by combining the analysis unit, so that a brand new solution is provided for the technical problem of real-time monitoring of gastric reflux. The device can realize real-time and continuous monitoring of the pH change of the key part, thereby rapidly capturing the occurrence of gastric reflux. When gastric juice is reversed to the above region, its acidic nature causes a significant drop in local pH, which can be detected by the pH sensor in time and transmitted to the analysis unit. The analysis unit can accurately judge the specific condition of gastric reflux by deeply analyzing the change condition of the pH value along with time. The method not only improves the sensitivity and accuracy of monitoring, but also enables medical staff to take precautionary measures at the first time of occurrence of an event, thereby effectively reducing the risk of aspiration and the probability of serious complications caused by aspiration, such as aspiration pneumonia or Acute Respiratory Distress Syndrome (ARDS). In addition, through the pH value change of accurate monitoring different positions, the device can also help discernment reverse flow route, provides the scientific basis for making individualized treatment scheme.
According to a preferred embodiment, the first pH sensor and the second pH sensor can be data-transmitted by means of wires and/or wirelessly, wherein the data-transmission line of the first pH sensor and/or the second pH sensor can be led out of the patient by means of attachment or embedding of the tracheal tube side wall and connected to the analysis unit during the wired transmission.
The first pH value sensor and the second pH value sensor can be connected with the analysis unit in a wired or wireless mode, and the design greatly enhances the flexibility and the practicability of the system. When the wired transmission is adopted, the data line of the sensor can be attached to or arranged in the side wall of the tracheal intubation, so that the dependence on the external environment is reduced while the stable transmission of signals is ensured, and the risk of electromagnetic interference is reduced. The wiring mode not only ensures the real-time performance and the integrity of data, but also avoids the physical damage or the hidden infection trouble possibly caused by the exposure of the circuit. In the case of wireless transmission, the application of a short-range communication protocol such as Bluetooth Low Energy (BLE) allows the sensor to achieve efficient data interaction without affecting the freedom of patient movement. This not only simplifies the device installation process, but also improves patient comfort, especially in situations where frequent adjustment of the overall position is required. Whichever transmission mode is selected, the design can ensure reliable transmission of data, so that medical staff can continuously monitor the pH value change of a patient, thereby finding potential gastric reflux problems earlier and taking corresponding measures, and improving the safety and treatment effect of the patient.
According to a preferred embodiment, the first pH sensor and the second pH sensor can be arranged in the corresponding arrangement areas in a position relatively closer to the esophagus in the current area, wherein the first pH sensor can be arranged in different positions depending on the type of endotracheal tube used by the mechanically ventilated patient, including oral, nasal, tracheostomy tubes.
The first and second pH sensors can be positioned closer to the esophageal side in the corresponding deployment region, which helps to more accurately capture the initial signs of gastric reflux. Particularly for patients using oral, nasal or tracheostomy tubes, the function of each sensor can be maximally exerted by selecting different sensor setting positions according to the specific type of cannula. For example, in the case of an oral cannula, the placement of the first pH sensor on the outer wall of the tracheal cannula in the mouth or in the epiglottis area allows direct monitoring of gastric reflux to the pharynx, whereas for a nasal cannula it is placed near the epiglottis in order to detect the effect of gastric reflux at the earliest. Such a layout design not only allows for anatomical rationality, but also embodies the need for personalized care for different types of catheterized patients. By means of the targeted sensor configuration, the device can immediately respond when gastric reflux occurs, provide instant early warning, reduce the possibility of aspiration, and provide a precious time window for subsequent intervention. The positioning strategy fully utilizes the characteristics of the anatomical structure, so that the sensor can be in closer contact with the target mucous membrane, and the accuracy and the sensitivity of pH value measurement are improved. For example, the epiglottis is the junction of the respiratory tract and the digestive tract, and the pH changes in its vicinity are mainly caused by gastric juice and not other external factors. Thus, the placement of the first pH sensor therein may significantly improve the specificity of the detection, reducing the possibility of false positives. Meanwhile, the sensor with strong pertinence is not only beneficial to timely capturing the occurrence of reflux events, but also can provide reliable diagnosis basis for clinicians to guide subsequent treatment decisions. Through setting up pH value sensor in epiglottis region, the device can send the police dispatch newspaper in the initial stage that gastric reflux took place, gives medical personnel precious intervention opportunity in advance to effectively reduce the risk of aspiration, ensure patient's respiratory safety.
According to a preferred embodiment, for a patient with an endotracheal tube being an oral tube, the first pH sensor can be arranged on the outer wall of the area of the endotracheal tube located in the mouth or epiglottis of the patient, wherein if the first pH sensor is arranged on the outer wall of the area of the endotracheal tube located in the mouth of the patient, it is arranged on the side of the outer wall of the area of the endotracheal tube located towards the tongue of the patient, and if the first pH sensor is arranged on the outer wall of the area of the endotracheal tube located in the epiglottis of the patient, it is arranged on the side of the outer wall of the area of the endotracheal tube located towards the back of the patient.
According to a preferred embodiment, for a patient with a nasal cannula as the tracheal cannula, the first pH sensor can be arranged on the outer wall of the tracheal cannula in the region of the patient's epiglottis and on the side of the outer wall of the tracheal cannula in the region facing in the direction of the back of the patient.
According to a preferred embodiment, for patients with tracheostomy tubes, the first pH sensor is not provided, but the second pH sensor is provided only in the area of the endotracheal tube where the dilatation balloon is located.
According to a preferred embodiment, the second pH sensor can be arranged on the outer wall of the tracheal cannula or on the upper end face of the dilatation balloon, wherein the second pH sensor can be arranged on the side of the outer wall of the tracheal cannula, which is close to the dilatation balloon, facing the back of the patient, when the second pH sensor is arranged on the outer wall of the tracheal cannula, and can be arranged on the upper end face of the dilatation balloon, which is close to the back of the patient, when the second pH sensor is arranged on the upper end face of the dilatation balloon.
This design not only allows for anatomical rationality, but also fully accounts for the operating environment and performance requirements of the sensor. The second pH value sensor is arranged on the outer wall of the tracheal cannula close to the expansion balloon, so that the second pH value sensor can be ensured to be close to the tracheal wall, and therefore pH change caused by gastric reflux is better perceived. When the sensor is positioned on the upper end face of the expansion air bag, the sensor can directly monitor the pH condition of the area above the air bag, which is the last defense line before gastric juice is mistakenly inhaled into the lung. By means of the well-designed arrangement, the second pH value sensor can react at the moment when gastric reflux occurs, and instant early warning is provided. In addition, the high sensitivity and rapid response characteristics of the sensor allow it to capture small pH fluctuations, and accurately detect even with small amounts of reflux. The arrangement not only improves the sensitivity and accuracy of monitoring, but also provides more detailed pathological information for clinicians, helps the clinicians to discover potential problems earlier and take appropriate intervention measures, thereby effectively reducing the risk of aspiration and protecting the life health of patients.
According to a preferred embodiment, after receiving the pH value of the patient corresponding area acquired by the first pH value sensor, the analysis unit can compare the pH value with theoretical data built in the analysis unit to determine the deviation degree of the real-time acquired data, wherein the theoretical data comprises first theoretical data and second theoretical data, the first theoretical data is ideal data of the change of the pH value of the patient corresponding area along with time under the condition of no interference of other additional factors, and the second theoretical data is correction data obtained by correcting the ideal data based on partially controllable nursing measures.
Through the double-layer comparison mechanism, the analysis unit can not only identify the actual change trend of the pH value, but also eliminate the influence caused by daily nursing measures, so that whether gastric reflux phenomenon exists or not can be judged more accurately. The method not only improves the sensitivity and the specificity of monitoring, but also provides more reliable diagnosis basis for clinicians. Through learning and updating the historical big data, the analysis unit can continuously optimize the built-in theoretical data, so that the data more accords with individual differences, and the monitoring effect is further improved. In a word, the method based on theoretical data comparison not only solves the problems of monitoring delay and error in the prior art in principle, but also provides powerful support for personalized medical treatment, and is beneficial to improving the quality and efficiency of intensive care.
According to a preferred embodiment, the analysis unit is capable of generating a corresponding analysis result based on a deviation degree of the pH value of the corresponding region of the patient acquired by the first pH sensor from the built-in theoretical data, and/or directly generating the analysis result based on a comparison result of the pH value of the region of the inflatable balloon on the tracheal cannula acquired by the second pH sensor with a preset fixed value, wherein the analysis result includes whether the patient has gastric reflux and the severity of the gastric reflux.
The method combines the pH value change information of two different positions to form a multi-dimensional monitoring system. Firstly, by analyzing the data acquired by the first pH value sensor, whether the gastric juice starts to reflux or not can be primarily judged, and the influence range of the gastric juice on the upper respiratory tract can be estimated. Then, by means of the data of the second pH sensor, the analysis unit can directly detect the pH change inside the trachea, in particular when the pH value is below a preset fixed value, indicating that the stomach content has been reversed flow into the airway and thus inhaled into the lungs. The dual verification mechanism not only improves the accuracy of monitoring, but also can distinguish reflux events in different stages and provide more detailed disease progress information for clinicians. More importantly, by integrating information of a plurality of data sources, the device can recognize the risk of gastric reflux earlier, give an alarm timely, give medical staff valuable early intervention opportunities, and effectively reduce aspiration and serious complications caused by aspiration, such as aspiration pneumonia or Acute Respiratory Distress Syndrome (ARDS). The method not only solves the limitation of the existing monitoring means from the technical aspect, but also provides a more scientific and efficient management tool for intensive care, and is beneficial to improving the prognosis of patients.
According to a preferred embodiment, the analysis unit can be integrated on a terminal device with a display unit, so that the data information received by the analysis unit and the analysis results generated from the data information can be displayed to the medical staff in a visual manner via the display unit.
The design not only simplifies the data analysis flow, but also enables the monitoring result to be displayed in a visual mode, thereby greatly facilitating the operation and interpretation of medical staff. Through the display unit, the data information received by the analysis unit and the analysis result generated according to the data can be intuitively presented to medical staff, so that the medical staff can clearly know the pH value change trend of the patient and the significance behind the pH value change trend. In addition, the terminal equipment can be provided with an operation unit for adjusting equipment parameters so as to meet the personalized requirements of different users. More importantly, the terminal equipment can be further provided with an alarm unit, and corresponding alarm signals are sent out according to gastric reflux severity of different levels to remind medical staff to take actions in time. The terminal equipment integrating the display, operation and alarm functions not only improves the overall performance of the monitoring system, but also enhances the practicability and user experience. In this way, the medical staff can obtain more timely and accurate feedback, thereby more effectively managing and preventing gastric reflux and related complications thereof, and finally improving the quality of intensive care and the safety of patients.
Drawings
FIG. 1 is a hardware connection diagram of a gastric reflux prediction device provided by the invention;
FIG. 2 is a schematic view of the placement of a pH sensor on an oral cannula in one embodiment provided by the present invention;
FIG. 3 is a schematic view of the arrangement of pH sensors on an oral cannula in another embodiment provided by the present invention;
FIG. 4 is a schematic view of the arrangement of the pH sensor on the nasal cannula provided by the invention;
FIG. 5 is a schematic view of the placement of the pH sensor on a tracheostomy tube provided by the present invention;
FIG. 6 is a schematic view showing the arrangement of the first pH sensor on the oral cannula according to the present invention;
FIG. 7 is a schematic view showing the placement of a second pH sensor on an oral cannula according to the present invention;
FIG. 8 is a schematic diagram of the layout position of a second pH sensor according to an embodiment of the present invention;
FIG. 9 is a schematic diagram of a layout position of a second pH sensor according to another embodiment of the present invention;
FIG. 10 is a graphical representation of the variation of first theoretical data of the area near the mouth provided by the present invention;
FIG. 11 is a graphical representation of the change in second theoretical data for the area near the mouth provided by the present invention;
fig. 12 is a graph showing the actual pH change of normal control group and intensive care patients in the vicinity of the oral cavity according to the present invention.
List of reference numerals
100 Parts of a first pH value sensor, 110 parts of a data transmission line, 200 parts of a second pH value sensor, 300 parts of a terminal device, 310 parts of an analysis unit, 400 parts of an endotracheal tube, 410 parts of an inflatable balloon, 420 parts of an oral tube, 430 parts of a nasal tube and 440 parts of a tracheostomy tube.
Detailed Description
The following detailed description refers to the accompanying drawings.
The present invention discloses a gastric reflux prediction device for mechanically ventilated patients, which may be particularly intensive care patients. Mechanical ventilation refers to assisting or replacing the spontaneous respiratory function of a patient through the use of mechanical devices. During the mechanical ventilation, the physician will choose the appropriate ventilation mode and parameter settings depending on the patient's particular situation. Typically, this involves inserting a specially-made catheter (referred to as endotracheal tube 400 or tracheostomy tube 440) into the patient's airway to create a safe airway passage. Subsequently, the endotracheal tube 400 connected to the ventilator can deliver air or other mixed gases (e.g., higher oxygen content gases) to the lungs at a predetermined frequency and tidal volume. Modern ventilators have a variety of modes of ventilation, including controlled ventilation (fully machine controlled breathing), assisted/controlled ventilation (combining spontaneous breathing and machine assistance of the patient), pressure support ventilation (providing additional pressure support only when the patient attempts to breathe), and non-invasive positive pressure ventilation (providing ventilation support by way of a mask, without the need for an endotracheal tube 400), to accommodate the needs of different conditions.
In order to reduce the risk of gastric reflux and its attendant aspiration in mechanically ventilated patients, the gastric reflux prediction device of the present invention is configured as shown in fig. 1 to include a first pH sensor 100 for measuring the pH of the oral cavity or epiglottis region of the patient, a second pH sensor 200 for measuring the pH of the region of the tracheal cannula 400 where the dilatation balloon 410 is located, and an analysis unit 310 for receiving and analyzing the pH collected by the pH sensor.
Preferably, the first pH sensor 100 and the second pH sensor 200 may be made of a material with good biocompatibility and acid and alkali corrosion resistance, such as a glass electrode or an Ion Sensitive Field Effect Transistor (ISFET), etc. The materials can ensure the stability of long-term use and can not cause stimulation to patients. Preferably, the first and second pH sensors 100 and 200 may have a rapid response characteristic capable of accurately measuring pH changes within seconds in order to timely capture the occurrence of gastric reflux events. Preferably, the first and second pH sensors 100 and 200 may have high sensitivity to detect minute pH fluctuations, wherein the error range does not exceed ±0.1 pH units.
Preferably, the first pH sensor 100 and the second pH sensor 200 may perform data transmission by wired and/or wireless means. For example, for the first and second pH sensors 100 and 200 disposed on the endotracheal tube 400, the data transmission line 110 may be drawn out of the patient in a manner of being attached to or built into the sidewall of the endotracheal tube 400 and connected to the analyzing unit 310. As another example, the first and second pH sensors 100, 200 may employ Bluetooth Low Energy (BLE) or other short range wireless communication protocol to enable data interaction with the analysis unit 310, thereby ensuring that the data can be transmitted to the analysis unit 310 in real time without affecting the freedom of movement of the patient. Preferably, in consideration of electromagnetic interference in an intensive care environment, the first pH sensor 100 and the second pH sensor 200 may have good shielding performance when using a wireless transmission method to ensure the quality of signal transmission. Preferably, the first and second pH sensors 100 and 200 may be built-in with a small memory so that data can be recorded even when connection and/or transmission is interrupted, preventing important information from being lost.
Preferably, the first and second pH sensors 100, 200 may have an auto-calibration function, allowing the sensors to calibrate themselves before or periodically each use, reducing the need for human intervention. Preferably, the first and second pH sensors 100 and 200 can be easily removed for cleaning and sterilization to meet hospital infection control standards.
Preferably, the first pH sensor 100 may be selected to be positioned differently depending on the type of endotracheal tube 400 used by the mechanically ventilated patient, which type of endotracheal tube 400 used by the mechanically ventilated patient may include an oral cannula 420, a nasal cannula 430, a tracheostomy tube 440, etc.
Preferably, as shown in Figs. 2 and 3, for a patient using oral cannula 420, oral cannula 420 enters from the patient's mouth, passes through the tissue of the soft palate, epiglottis, etc., and then enters the trachea through the throat, wherein oral cannula 420 contacts the tissue of the tongue, soft palate, etc., after insertion into the patient's mouth, then passes through the pharynx, contacts the posterior pharyngeal wall and the epiglottis, then passes through the throat, contacts the vocal cords and the tracheal ring, and finally reaches the trachea, contacting the tracheal wall. Preferably, a dilation balloon 410 for contact with the tracheal wall may be generally provided near the distal end of the orocannula 420, generally below the glottis, to prevent leakage of gas and entry of foreign objects into the trachea. Further, when the mechanical ventilation patient uses the oral cannula 420, the first pH sensor 100 may be installed in the area of the tracheal cannula 400 in the patient's mouth or epiglottis. This is because oral cannula 420 is inserted directly through the oral cavity into the trachea, which would pass through the oral cavity and the epiglottis area, and gastric reflux would also contact the back of the oral cavity and the epiglottis area, so that the presence of gastric juice can be detected in both positions, providing a more timely early warning, effectively reducing the risk of aspiration, protecting the lung health. Illustratively, the first pH sensor 100 may be disposed on the outer wall of the endotracheal tube 400 (i.e., orocannula 420) in the area of the patient's mouth or epiglottis to ensure intimate contact with the mucosa of the mouth or epiglottis area and to transmit data to the analysis unit 310 via the data transmission line 110 disposed within the endotracheal tube 400.
Preferably, as shown in fig. 4, for a patient using a nasal cannula 430, the nasal cannula 430 enters from the nostril of the patient, passes through the nasal vestibule, nasal passages (including inferior and medial turbinates), then through the nasopharynx into the pharynx, through the soft palate, epiglottis, and finally to the trachea, wherein the nasal cannula 430 passes through the nasal vestibule and contacts the nasal hair and mucosa after insertion into the nostril of the patient, passes through the inferior and medial turbinates, contacts the nasal passage mucosa, then passes through the nasopharynx, contacts the nasopharynx mucosa, passes through the pharynx, contacts the posterior pharyngeal wall and the epiglottis, then passes through the larynx, contacts the vocal cords and the tracheal rings, and finally to the trachea, contacts the tracheal wall. Preferably, a dilation balloon 410 for contact with the tracheal wall may be generally provided near the distal end of nasal cannula 430, generally below the glottis, to prevent leakage of gas and entry of foreign objects into the trachea. Further, when the nasal cannula 430 is used by a mechanically ventilated patient, the first pH sensor 100 may be mounted to the tracheal cannula 400 in the area of the patient's epiglottis. This is because nasal cannula 430 enters from the nasal cavity, bypasses the oral cavity and reaches the trachea, the epiglottis is the place where the respiratory tract meets the digestive tract, the vicinity of which is the first most significant point of contact for gastric reflux, and first pH sensor 100 is positioned to provide early warning that gastric reflux reaches the pharynx, thereby reducing the risk of aspiration, and greatly reducing false alarm rate because the pH change in the epiglottis region is primarily caused by gastric juice, and not other factors. Illustratively, the first pH sensor 100 may be disposed on the outer wall of the endotracheal tube 400 (i.e., nasal cannula 430) in the region of the patient's epiglottis to ensure intimate contact with the mucosa of the epiglottis region and to transmit data to the analysis unit 310 via the data transmission line 110 disposed within the endotracheal tube 400.
Preferably, as shown in fig. 5, for patients using a tracheostomy tube 440, a tracheotomy is typically performed at a midline position of their neck to form an incision that allows insertion of the tracheostomy tube 440, where the tracheotomy is performed generally between a first cartilage ring and a second cartilage ring below thyroid cartilage (laryngeal node). The incision is typically either transverse or longitudinal to reduce scar formation after surgery. The incision is first made through the skin and into the subcutaneous tissue layer, including subcutaneous fat and superficial fascia. The subcutaneous tissue layer is thinner and is easy to separate. Continuing downwards, the incision will pass through the muscular layers of the neck, including the platysma (platysma), the sternocleidomastoid (sternocleidomastoid muscle), and the hyoid muscle group (infrahyoid muscles). These muscles are typically separated or cut to expose the trachea. The anterior fascia (PRETRACHEAL FASCIA) of the trachea, which covers the anterior aspect of the trachea, is a thin layer of connective tissue that, when incised, exposes the anterior wall of the trachea. Tracheostomy tube 440 is ultimately inserted into the trachea through the incision. Preferably, a dilation balloon 410 for contact with the tracheal wall may be generally provided near the distal end of tracheostomy tube 440, generally below the glottis, to prevent leakage of gas and entry of foreign objects into the trachea. Further, since tracheostomy tube 440 is directly connected to the lower tracheal section, typically below the cricoid, away from the beginning of the path of gastric reflux, in which case first pH sensor 100 may not be provided.
Further, the first pH sensor 100 may be integrated with a medical device that is currently being used or is to be used by a mechanically ventilated patient, in addition to being placed on the endotracheal tube 400 at a location corresponding to the patient's oral cavity or epiglottis region, for example, for a patient using the orocannula 420, the first pH sensor 100 may be placed on a bite block of a holder for the orocannula 420, or may be configured as a stand-alone device to be placed directly at the corresponding location. Preferably, the first pH sensor 100 is positioned to provide a first line of defense against gastric reflux into the upper airway, thus most reflective of reflux.
Preferably, the second pH sensor 200 may be positioned on the endotracheal tube 400 in the region of the dilatation balloon 410 to measure the pH in the vicinity, wherein the dilatation balloon 410 (also referred to as a cuff or balloon catheter) on the endotracheal tube 400 is positioned on the distal portion of the tube, i.e. on the side closer to the tip, and when the endotracheal tube 400 is properly inserted into the patient's trachea, the dilatation balloon 410 is positioned in the trachea against the tracheal wall. Further, the inflatable balloon 410 of the endotracheal tube 400 can form a sealed environment after inflation, preventing gas leakage, ensuring that tidal volumes during mechanical ventilation can effectively enter the lungs.
Further, the second pH sensor 200 may be provided on the dilatation balloon 410 in addition to the outer wall of the endotracheal tube 400, and may be provided in particular on the end face (i.e. upper end face) of the dilatation balloon 410 facing the patient's head. Whether disposed on the outer wall of the endotracheal tube 400 or on the dilatation balloon 410, the second pH sensor 200 is disposed in a position closer to the patient's head than the dilatation balloon 410 body.
Preferably, the first and second pH sensors 100 and 200 can be disposed relatively closer to the esophagus in the current area after determining the placement area. For example, if the first pH sensor 100 is disposed on the outer wall of the area of the endotracheal tube 400 located in the patient's mouth, it may be preferable to dispose it on the side of the outer wall of the endotracheal tube 400 located in the area facing the patient's tongue, as shown in FIG. 6, and if the first pH sensor 100 is disposed on the outer wall of the area of the endotracheal tube 400 located in the patient's epiglottis, it may be preferable to dispose it on the side of the outer wall of the endotracheal tube 400 located in the area facing the back of the patient. For another example, as shown in fig. 7 to 9, the second pH sensor 200 may be disposed on a side of the outer wall of the tracheal cannula 400 near the dilatation balloon 410 toward the back of the patient, or disposed on a local position on the upper end surface of the dilatation balloon 410 near the back of the patient, where fig. 8 and 9 are cross-sectional views of the human body where the dilatation balloon 410 is located, and the two views respectively show different placement positions of the second pH sensor 200.
Preferably, the pH values collected by the first pH value sensor 100 and the second pH value sensor 200 in real time may be sent to the analysis unit 310, so that the analysis unit 310 may monitor one or more pH values in the patient's body, thereby judging the condition of gastric reflux of the patient.
Preferably, the analysis unit 310 may compare the pH value of the corresponding region (e.g., the oral cavity or the vicinity of the epiglottis) of the patient acquired by the first pH value sensor 100 with theoretical data built into the analysis unit 310 to determine the deviation degree of the real-time acquired data. Preferably, the analysis unit 310 can construct and update corresponding theoretical data for patients with different basic information according to historical big data and/or predictive models, wherein the theoretical data is the change condition of the pH value of the corresponding region of the patient with time. Preferably, the theoretical data may include first theoretical data and second theoretical data, wherein the first theoretical data is ideal data of the change of the pH value of the corresponding region of the patient with time without interference of other additional factors, and the second theoretical data is corrected data obtained by correcting the ideal data based on partially controllable nursing measures. Further, for pH values near the oral cavity, the second theoretical data is generally different from the first theoretical data thereof, as the patient typically needs to perform regular oral care with a weak acidic cleaner at intervals (e.g., 6 hours) to control bacteria, maintain oral humidity, and help stabilize oral pH, thereby preventing sustained pH drop. Whereas for pH values near the epiglottis, its second theoretical data is generally equal or about equal to its first theoretical data, since in current medical practice no care is specifically taken to adjust and stabilize the pH values near the epiglottis. But if other care measures indirectly affect the pH near the epiglottis, its second theoretical data is also not equal to its first theoretical data.
Illustratively, taking a pH near the mouth of a patient of a certain type as an example, the first theoretical data built in the analysis unit 310 can be as shown in fig. 10, where the pH gradually decreases from 7.0 to 6.2, the rate of decrease is most obvious at the first 12-24 hours, and the pH becomes stable but still at a lower level after 72 hours. Based on this, the health care professional can perform regular oral care with a weakly acidic cleaner every 6 hours, thereby controlling and adjusting the pH thereof to obtain second theoretical data as shown in fig. 11. As shown in fig. 12, although the pH value is drastically lowered when the patient suffers from gastric reflux, the fluctuation range of the pH value is significantly larger than that of the normal control group, especially for the intensive care patient, and therefore, it is necessary to more accurately determine whether gastric reflux has actually occurred by comparing with the second theoretical data. As shown in fig. 12, the pH change of the normal control group was very small, the fluctuation range was maintained at 6.9-7.1, and the pH of the intensive care patient was reduced to 6.5 at the node of 6 hours, which is pH change due to oral care, suddenly reduced to 6.2 at the node of 12 hours, which is pH sharp drop due to gastric reflux, returned to 6.7 at the node of 18 hours, which is pH change due to oral care, and again reduced to 6.3 at the node of 24 hours, which is pH sharp drop due to gastric reflux.
Preferably, the analysis unit 310 may generate a corresponding analysis result based on the deviation degree of the pH value of the corresponding region (such as the oral cavity or the vicinity of the epiglottis) of the patient acquired by the first pH value sensor 100 from the built-in theoretical data (i.e., the first theoretical data and/or the second theoretical data), wherein the analysis result may include whether the patient has gastric reflux and the severity of the gastric reflux. Preferably, after excluding the influence of the partially controllable care measure on the pH value of the corresponding area, for the case that the change rate of the adjacent node exceeds the preset threshold, the analysis unit 310 may identify the node relatively later as having gastric reflux, and may determine the severity of gastric reflux according to the range in which the corresponding change rate is located.
Preferably, the analysis unit 310 may determine whether the gastric juice aspiration occurs based on the comparison result of the pH value of the area of the tracheal cannula 400 where the dilatation balloon 410 is located acquired by the second pH sensor 200 and a preset fixed value, wherein when the pH value acquired by the second pH sensor 200 is lower than the preset fixed value, it indicates that there is a procedure of gastric contents flowing back into the airway and being inhaled into the lung. Gastric aspiration is a serious medical problem because it can lead to a number of adverse consequences including Acute Respiratory Distress Syndrome (ARDS), aspiration pneumonia, and other respiratory complications. Therefore, when the analysis unit 310 determines that the pH value collected by the second pH sensor 200 is lower than the preset fixed value, a corresponding analysis result can be directly generated, wherein the severity of gastric reflux in the analysis result can be set to be the highest. In other words, the severity of gastric reflux that occurs may not be determined by the deviation degree of the pH value of the patient corresponding region collected by the first pH sensor 100 from the built-in theoretical data, but if the analysis unit 310 determines that no gastric reflux occurs in the patient according to the deviation degree of the pH value of the patient corresponding region collected by the first pH sensor 100 from the built-in theoretical data, the interference of other factors such as equipment faults (e.g. sensor faults, communication faults) needs to be removed to ensure the accuracy of data collection and analysis.
Preferably, the endotracheal tube 400 for mechanical ventilation may be of a double lumen catheter design, wherein the double lumen catheter may comprise a gas channel for maintaining the function of the gas delivery of the existing endotracheal tube 400, ensuring that oxygen and other mixed gases can smoothly enter the lungs according to preset parameters, and a suction channel, which may be located beside or in the inner layer of the gas channel within the endotracheal tube 400 and isolated from the endotracheal tube 400, so that the suction channel, when connected directly to the negative pressure suction device, may extract regurgitated or erroneously sucked gastric juice without disturbing the gas inflow. The suction channel may take a spiral or other optimized shape to reduce the occupation of airway space and prevent blockage. Preferably, the suction channel may be provided with a suction port in a partial region of the tracheal cannula 400, wherein the opening position of the suction port is associated with the layout position of the pH value sensor, that is, the opening position of the suction port is located near the layout position of the pH value sensor, so that when the corresponding pH value sensor detects that the patient has reflux or aspiration, the suction in the corresponding region may be completed in a targeted manner. For example, the suction port may be provided at a location of the endotracheal tube 400 that is located in the patient's mouth or epiglottis or near the trachea, where a location in the patient's near the trachea may be particularly referred to as a location in the area above the dilation balloon 410.
By locating the aspiration port near a critical area near the pH sensor, such as the oral cavity, epiglottis, or trachea (particularly the area above the dilation balloon 410), the device is able to immediately initiate the aspiration procedure upon detection of regurgitation or aspiration of gastric juice, directly to the specific site affected. The method not only improves the accuracy and efficiency of suction, but also can rapidly remove the gastric juice locally accumulated, and effectively reduces the risk of serious complications caused by aspiration. Compared with the traditional method, the targeted aspiration mechanism greatly reduces the possibility of further diffusion of aspiration substances, thereby better protecting the respiratory tract of a patient from damage. Furthermore, the design of the dual lumen catheter ensures complete separation of the gas delivery and liquid extraction processes so that respiratory support is not compromised, maintaining a stable gas exchange environment. This feature is particularly important for critically ill patients because it ensures that the necessary oxygen supply is continuously provided even in emergency situations, avoiding respiratory interruption or instability due to the aspiration procedure. From the point of view of clinical application, the improvement greatly simplifies the operation flow of medical staff, reduces the extra burden caused by processing reflux or aspiration events, and simultaneously provides a more visual feedback mechanism to help them to make correct decisions in time. For patients, the design can respond to gastric reflux or aspiration in a shortest time, minimize potential injury and significantly improve prognosis quality.
Preferably, after the patient undergoes countermeasures automatically implemented or manually implemented by medical staff after gastric reflux or aspiration, when the pH value of the corresponding region of the pH value sensor is in the normal range, the analysis unit 310 may reset the theoretical data, and predict and compare again with the current time as a new starting time, so as to improve the accuracy of prediction.
Preferably, the analysis unit 310 may be integrated on the terminal device 300 with a display unit, so that the data information received by the analysis unit 310 and the analysis result generated according to the data information may be visually displayed to the medical staff through the display unit, so that the medical staff may intuitively grasp the condition of gastric reflux of the patient. Preferably, the terminal device 300 may be provided with an operation unit for parameter adjustment of the terminal device 300 itself and/or a sensor connected to the terminal device 300, so as to conform to the usage habits of different users. Preferably, the terminal device 300 may be provided with an alarm unit, so that when the analysis unit 310 determines that the patient has gastric reflux based on the analysis result generated by the alarm unit, different alarm signals can be sent according to the severity of gastric reflux that occurs currently, thereby reminding the medical staff to process in time.
It should be noted that the above-described embodiments are exemplary, and that a person skilled in the art, in light of the present disclosure, may devise various solutions that fall within the scope of the present disclosure and fall within the scope of the present disclosure. It should be understood by those skilled in the art that the present description and drawings are illustrative and not limiting to the claims. The scope of the invention is defined by the claims and their equivalents. The description of the invention incorporating multiple inventive concepts, such as "preferably" or "according to a preferred embodiment" each indicating that the corresponding paragraph discloses a separate concept, applicant reserves the right to filed a divisional application according to each inventive concept. Throughout this document, the word "preferably" is used in a generic sense to mean only one alternative, and not to be construed as necessarily required, so that the applicant reserves the right to forego or delete the relevant preferred feature at any time.
Claims (7)
1. A gastric reflux prediction device for a mechanically ventilated patient, comprising:
A first pH sensor (100) for measuring the pH of the patient's mouth or epiglottis region;
a second pH sensor (200) for measuring the pH value of the area where the dilatation balloon (410) on the tracheal cannula (400) is located, wherein the dilatation balloon (410) on the tracheal cannula (400) can be arranged in the trachea of the patient and is in contact with the tracheal wall, the second pH sensor (200) can be arranged at a position relatively closer to the esophagus in the current area in the corresponding arrangement area, can be arranged on the outer wall of the tracheal cannula (400) or on the upper end surface of the dilatation balloon (410), wherein when the second pH sensor (200) is arranged on the outer wall of the tracheal cannula (400), the second pH sensor can be arranged on the side, facing the back direction of the patient, of the tracheal cannula (400) close to the outer wall of the dilatation balloon (410), and when the second pH sensor (200) is arranged on the upper end surface of the dilatation balloon (410), the second pH sensor (200) can be arranged on the upper end surface of the dilatation balloon (410) at a local position close to the back of the patient;
An analysis unit (310) for receiving the pH value collected by the pH value sensor and analyzing the pH value,
The analysis unit (310) is configured to:
Determining the pH of the patient's mouth or epiglottis region over time based on the pH provided by the first pH sensor (100),
Determining the change of the pH value of the upper end of the expansion balloon (410) along with time according to the pH value provided by the second pH value sensor (200),
After receiving the pH value of the corresponding region of the patient collected by the first pH value sensor (100), the pH value can be compared with theoretical data built in the analysis unit (310) to judge the deviation degree of the real-time collected data and generate corresponding analysis results, and/or the analysis results are directly generated based on the comparison result of the pH value of the region of the expanded air bag (410) on the tracheal cannula (400) collected by the second pH value sensor (200) and a preset fixed value,
The theoretical data comprise first theoretical data and second theoretical data, the first theoretical data are ideal data of the change of the pH value of a corresponding region of the patient along with time under the condition that no other additional factors interfere, the second theoretical data are corrected data obtained by correcting the ideal data based on partially controllable nursing measures, and analysis results comprise whether gastric reflux occurs in the patient and the severity of the gastric reflux.
2. Gastric reflux prediction device according to claim 1, characterized in that the first pH sensor (100) and the second pH sensor (200) are capable of data transmission by wire and/or wirelessly, wherein the data transmission line (110) of the first pH sensor (100) and/or the second pH sensor (200) is capable of being led out of the patient and connected to the analysis unit (310) by means of attachment or embedding in the side wall of the tracheal cannula (400) when transmitted by wire.
3. Gastric reflux prediction device according to claim 1 or 2, characterized in that the first pH sensor (100) can be arranged in a corresponding arrangement area in a position relatively closer to the esophagus in the current area, wherein the first pH sensor (100) can be arranged in different positions depending on the type of tracheal tube (400) used by the mechanically ventilated patient, including oral cannula (420), nasal cannula (430), tracheostomy tube (440).
4. The gastric reflux prediction device according to claim 3, wherein for a patient with an endotracheal tube (400) being an orotube (420), the first pH sensor (100) is capable of being placed on the outer wall of the area of the endotracheal tube (400) located in the mouth or epiglottis of the patient, wherein if the first pH sensor (100) is placed on the outer wall of the area of the endotracheal tube (400) located in the mouth of the patient, it is placed on the side of the outer wall of the endotracheal tube (400) located in the area facing the tongue of the patient, and if the first pH sensor (100) is placed on the outer wall of the area of the endotracheal tube (400) located in the direction of the back of the patient, it is placed on the side of the outer wall of the endotracheal tube (400) located in the area facing the back of the patient.
5. A gastric reflux predicting device according to claim 3, characterized in that for a patient with a tracheal tube (400) being a nasal cannula (430), the first pH sensor (100) can be arranged on the outer wall of the tracheal tube (400) in the area of the patient's epiglottis and on the side of the tracheal tube (400) on the outer wall in the area facing in the direction of the patient's back.
6. The gastric reflux predicting device according to claim 3, characterized in that the first pH sensor (100) is not provided for a patient whose tracheal tube (400) is a tracheostomy tube (440), and the second pH sensor (200) is provided only in the area of the dilating balloon (410) on the tracheal tube (400).
7. Gastric reflux prediction device according to claim 1, characterized in that the analysis unit (310) can be integrated on a terminal device (300) with a display unit, so that the data information received by the analysis unit (310) and the analysis results generated from these data information can be presented to the medical staff visually via the display unit.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| AU2003284235A1 (en) * | 2003-10-16 | 2004-06-06 | Anibal De Oliveira Fortuna | A combination artficial airway device and esophageal obturator |
| US9956367B1 (en) * | 2014-01-06 | 2018-05-01 | Yang Sun | Laryngascope free airway device |
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| US5360003A (en) * | 1993-06-11 | 1994-11-01 | Capistrano Cecilio L | Intubation assembly and method of inserting same having a balloon to indicate the position of tube inside of the patient |
| US7040322B2 (en) * | 2001-11-08 | 2006-05-09 | Fortuna Anibal De Oliveira | Combination artificial airway device and esophageal obturator |
| WO2018092150A1 (en) * | 2016-11-18 | 2018-05-24 | Kalyanaraman Ananthanarayanan | Oral/nasal resuscitator with superior ventilating capacity |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2003284235A1 (en) * | 2003-10-16 | 2004-06-06 | Anibal De Oliveira Fortuna | A combination artficial airway device and esophageal obturator |
| US9956367B1 (en) * | 2014-01-06 | 2018-05-01 | Yang Sun | Laryngascope free airway device |
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