Gastric juice reflux prediction device for patient with mechanical ventilation

Abstract

The invention relates to a gastric juice reflux prediction device for a patient with mechanical ventilation, and belongs to the technical field of medical equipment. The gastric juice reflux prediction device comprises a first pH value sensor used for measuring the pH value of the oral cavity or epiglottis area of a patient; the second pH value sensor is used for measuring the pH value of the area where the dilation air bag on the trachea cannula is located; the analysis unit is used for receiving the pH value collected by the pH value sensor and analyzing and processing the pH value, and the analysis unit is configured to determine the change condition of the pH value of the oral cavity or epiglottis area of the patient along with time according to the pH value provided by the first pH value sensor; according to the pH value provided by the second pH value sensor, the change condition of the pH value of the upper end of the dilation air bag along with time is determined, and the dilation air bag on the trachea cannula can be arranged in the trachea of the patient and makes contact with the trachea wall.

Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to a gastric reflux prediction device for mechanically ventilated patients. Background Art

[0002] Mechanical ventilation refers to the use of mechanical equipment to assist or replace the patient's spontaneous breathing function. When patients are unable to maintain adequate gas exchange due to various reasons (such as acute respiratory distress syndrome, acute exacerbation of chronic obstructive pulmonary disease, neuromuscular disease, severe trauma or postoperative recovery, etc.), mechanical ventilation can provide the necessary support to ensure that oxygen is adequately delivered to the blood and carbon dioxide is effectively removed. This process not only helps stabilize the patient's respiratory status, but also buys time to treat the underlying cause.

[0003] In the intensive care environment, patients on mechanical ventilation are often at risk for a series of complications, one of which is gastric reflux. Because these patients are usually in a sedated or comatose state and need to rest in bed for a long time, coupled with the impact of mechanical ventilation itself, they are more likely to experience reflux of gastric contents. This condition not only increases the risk of aspiration, which may lead to serious complications such as aspiration pneumonia, but may also affect the effectiveness of mechanical ventilation and the patient's recovery process.

[0004] Mechanical ventilation maintains the patient's breathing function through artificial means. When the endotracheal tube is inserted, an inflatable balloon is placed to seal the airway to ensure that the gas does not leak and prevent foreign objects from entering the lower respiratory tract. However, even so, gastric reflux is still a potential problem. Gastric juice is highly acidic and may contain food particles, bacteria and other harmful substances. If these substances are inhaled into the lungs, they may cause chemical damage, leading to alveolar inflammatory response, and then develop into aspiration pneumonia, which is one of the common types of infection in intensive care units, significantly increasing the patient's mortality rate and length of hospital stay.

[0005] CN112169122A discloses an adjustable-length reflux warning oropharyngeal and nasopharyngeal airway, comprising an inner sleeve, an outer sleeve, a pusher, a color display system and an alarm system, one end of the inner sleeve is arranged inside the outer sleeve and can move back and forth along the inner wall of the outer sleeve, the other end is connected to the pusher, the color display system is arranged on the inner wall of the inner sleeve and the inner wall of the pusher, one end of the alarm system passes through the pusher and the inner sleeve and is arranged on the end face of the inner sleeve away from one end of the pusher, and the other end is installed on the outer wall of the pusher.

[0006] CN110478584A discloses an integrated intelligent laryngeal mask with pH and temperature monitoring functions, comprising a mask body, a mask bag, and a ventilation tube cavity. The mask body is provided with a linear groove, and the mask body is provided with a signal transmission line tube cavity and a drainage tube cavity, which are respectively connected to the temperature sensor probe microcavity on the mask body, and the pH sensor probe microcavity and the drainage port arranged in the linear groove; one end of the pH sensor signal transmission line and the temperature sensor signal transmission line arranged in the signal transmission line tube cavity are respectively connected to the micro pH sensor probe and the micro temperature sensor probe, and the other end is connected to a multifunctional signal processing display.

[0007] During the intensive care of mechanically ventilated patients, gastric reflux and the associated risk of aspiration pose a significant and urgent problem. One of the current clinical challenges is the difficulty in achieving real-time monitoring of gastric reflux. Traditional monitoring methods often rely on sampling and then sending the samples for testing, which is not only time-consuming but also unable to provide immediate data feedback, resulting in medical staff only being able to learn the results some time after the event. This delay makes it difficult to take timely preventive or intervention measures, thereby increasing the risk of patients suffering from serious complications due to aspiration, such as aspiration pneumonia and acute respiratory distress syndrome (ARDS). Another important issue is that existing technologies lack the ability to provide early warning for gastric reflux. Since gastric reflux usually occurs suddenly and without obvious signs, especially when the patient is sedated or comatose, the protective reflex is weakened or lost, which makes it difficult for traditional monitoring methods to detect and prevent aspiration in advance. Without an effective early warning mechanism, medical staff can only passively respond to reflux events that have already occurred, rather than actively preventing them from happening, which poses a potential threat to patient safety.

[0008] In addition, on the one hand, there are differences in understanding among those skilled in the art; on the other hand, the applicant studied a large number of documents and patents when making the present invention, but due to space limitations, not all details and contents are listed in detail. However, this does not mean that the present invention does not have the characteristics of these prior arts. On the contrary, the present invention already has all the characteristics of the prior art, and the applicant reserves the right to add relevant prior art to the background technology. Summary of the invention

[0009] In view of the deficiencies of the prior art, the present invention provides a gastric reflux prediction device for mechanically ventilated patients to solve at least part of the above-mentioned technical problems.

[0010] The present invention discloses a gastric reflux prediction device for mechanically ventilated patients, which includes: a first pH sensor for measuring the pH value of the oral cavity or epiglottis of the patient; a second pH sensor for measuring the pH value of the area where the expansion balloon on the endotracheal tube is located; and an analysis unit for receiving the pH value collected by the pH sensor and analyzing and processing it. The analysis unit is configured to: determine the change of the pH value of the oral cavity or epiglottis of the patient over time according to the pH value provided by the first pH sensor, and determine the change of the pH value of the upper end of the expansion balloon over time according to the pH value provided by the second pH sensor, wherein the expansion balloon on the endotracheal tube can be set in the patient's trachea and contact the tracheal wall.

[0011] The gastric reflux prediction device of the present invention introduces a first pH sensor and a second pH sensor to measure the pH values ​​of the patient's oral cavity or epiglottis area and the area where the expansion balloon on the endotracheal tube is located, respectively, and processes these data in combination with an analysis unit, thereby providing a new solution to the technical problem of real-time monitoring of gastric reflux. The device can realize real-time and continuous monitoring of pH changes in key areas, thereby quickly capturing the occurrence of gastric reflux. When gastric juice flows back to the above-mentioned area, its acidic properties will cause the local pH value to drop significantly, and this change can be detected by the pH sensor in time and transmitted to the analysis unit. The analysis unit can accurately determine the specific situation of gastric reflux by conducting an in-depth analysis of the change of pH value over time. This method not only improves the sensitivity and accuracy of monitoring, but also enables medical staff to take preventive measures at the first time of the event, effectively reducing the risk of aspiration and the probability of causing serious complications, such as aspiration pneumonia or acute respiratory distress syndrome (ARDS). In addition, by accurately monitoring the pH value changes at different locations, the device can also help identify the reflux path and provide a scientific basis for formulating personalized treatment plans.

[0012] According to a preferred embodiment, the first pH sensor and the second pH sensor can perform data transmission via wired and / or wireless means, wherein, when transmitting via wired means, the data transmission line of the first pH sensor and / or the second pH sensor can be led out of the patient's body and connected to the analysis unit in a manner of being attached to or built into the side wall of the endotracheal tube.

[0013] The first pH sensor and the second pH sensor can be connected to the analysis unit by wire or wirelessly, which greatly enhances the flexibility and practicality of the system. When wired transmission is adopted, the data line of the sensor can be attached to or built into the side wall of the endotracheal tube, which ensures stable signal transmission while reducing dependence on the external environment and reducing the risk of electromagnetic interference. This wiring method not only ensures the real-time and integrity of the data, but also avoids the physical damage or infection risks caused by the exposure of the line. In the case of wireless transmission, the application of short-range communication protocols such as low-power Bluetooth (BLE) allows sensors to achieve efficient data interaction without affecting the patient's freedom of movement. This method not only simplifies the equipment installation process, but also improves the patient's comfort, especially when frequent position adjustment is required. Regardless of the transmission method selected, the design can ensure reliable data transmission, allowing medical staff to continuously monitor the patient's pH changes, so as to detect potential gastric reflux problems earlier and take corresponding measures to improve the patient's safety and treatment effect.

[0014] According to a preferred embodiment, the first pH sensor and the second pH sensor can be arranged in a position relatively closer to the esophagus in the current area in the corresponding layout area, wherein the first pH sensor can select different setting positions according to the type of endotracheal tube used by the mechanically ventilated patient, and the types of endotracheal tube used by the mechanically ventilated patient include oral cannula, nasal cannula, and tracheotomy tube.

[0015] The first pH sensor and the second pH sensor can be arranged closer to the esophagus in the corresponding layout area, which helps to capture the early signs of gastric reflux more accurately. Especially for patients who use oral intubation, nasal intubation or tracheotomy tubes, different sensor setting positions can be selected according to the specific intubation type to maximize the role of each sensor. For example, in the case of oral intubation, the first pH sensor is placed on the outer wall of the tracheal tube in the oral or epiglottic area, which can directly monitor the gastric reflux to the pharynx; while for nasal intubation, it is set near the epiglottis to detect the impact of gastric reflux as early as possible. Such a layout design not only takes into account the anatomical rationality, but also reflects the need for personalized care for patients with different types of intubation. Through this targeted sensor configuration, the device can respond immediately when gastric reflux occurs, provide immediate warning, reduce the possibility of aspiration, and provide a valuable time window for subsequent intervention measures. The above positioning strategy makes full use of the characteristics of the anatomical structure, allowing the sensor to contact the target mucosa more closely, thereby improving the accuracy and sensitivity of pH measurement. For example, the epiglottis is the intersection of the respiratory tract and the digestive tract, and the pH changes near it are mainly caused by gastric juice rather than other external factors. Therefore, placing the first pH sensor here can significantly improve the specificity of detection and reduce the possibility of false alarms. At the same time, this highly targeted sensor setting not only helps to capture the occurrence of reflux events in a timely manner, but also provides clinicians with a reliable diagnostic basis to guide subsequent treatment decisions. By setting a pH sensor in the epiglottis area, the device can sound an alarm in the initial stage of gastric reflux, giving medical staff a valuable opportunity to intervene in advance, thereby effectively reducing the risk of aspiration and ensuring the patient's breathing safety.

[0016] According to a preferred embodiment, for patients whose endotracheal tube is an oral tube, the first pH sensor can be arranged on the outer wall of the endotracheal tube in the area of ​​the patient's oral cavity or epiglottis, wherein if the first pH sensor is arranged on the outer wall of the endotracheal tube in the area of ​​the patient's oral cavity, it is arranged on the side of the outer wall of the endotracheal tube in this area facing the patient's tongue; if the first pH sensor is arranged on the outer wall of the endotracheal tube in the area of ​​the patient's epiglottis, it is arranged on the side of the outer wall of the endotracheal tube in this area facing the patient's back.

[0017] According to a preferred embodiment, for patients whose endotracheal tubes are nasal tubes, the first pH sensor can be arranged on the outer wall of the endotracheal tube located in the epiglottis of the patient and on one side of the outer wall of the endotracheal tube located in this area facing the patient's back.

[0018] According to a preferred embodiment, for patients whose endotracheal tube is a tracheotomy tube, the first pH sensor is not provided, and the second pH sensor is only provided in the area where the expansion balloon on the endotracheal tube is located.

[0019] According to a preferred embodiment, the second pH sensor can be arranged on the outer wall of the endotracheal tube or on the upper end surface of the expansion balloon, wherein, when the second pH sensor is arranged on the outer wall of the endotracheal tube, it can be arranged on the side of the outer wall of the endotracheal tube close to the expansion balloon facing the patient's back; when the second pH sensor is arranged on the upper end surface of the expansion balloon, it can be arranged at a local position on the upper end surface of the expansion balloon close to the patient's back.

[0020] This design not only takes into account anatomical rationality, but also fully considers the working environment and performance requirements of the sensor. Placing the second pH sensor on the outer wall of the endotracheal tube close to the expansion balloon ensures that it is close to the tracheal wall, so as to better sense the pH changes caused by gastric reflux. When the sensor is located on the upper end surface of the expansion balloon, it can directly monitor the pH condition of the area above the balloon, which is the last line of defense before gastric juice is accidentally aspirated into the lungs. Through this carefully designed arrangement, the second pH sensor can respond at the moment of gastric reflux and provide immediate warning. In addition, the high sensitivity and fast response characteristics of the sensor enable it to capture tiny pH fluctuations and accurately detect even when the reflux volume is small. This arrangement not only improves the sensitivity and accuracy of monitoring, but also provides clinicians with more detailed pathological information, helping them to detect potential problems earlier and take appropriate intervention measures, thereby effectively reducing the risk of aspiration and protecting the life and health of patients.

[0021] According to a preferred embodiment, after receiving the pH value of the patient's corresponding area collected by the first pH sensor, the analysis unit can compare it with the theoretical data built into the analysis unit to determine the degree of deviation of the real-time collected data, wherein the theoretical data includes first theoretical data and second theoretical data, the first theoretical data being ideal data of the pH value of the patient's corresponding area changing over time in the absence of interference from other additional factors; the second theoretical data being corrected data obtained by correcting the above ideal data based on partially controllable nursing measures.

[0022] Through this double-layer comparison mechanism, the analysis unit can not only identify the actual change trend of the pH value, but also eliminate the impact of daily care measures, so as to more accurately determine whether there is gastric reflux. This method not only improves the sensitivity and specificity of monitoring, but also provides clinicians with a more reliable basis for diagnosis. By learning and updating historical big data, the analysis unit can continuously optimize its built-in theoretical data to make it more in line with individual differences and further improve the monitoring effect. In short, this method based on theoretical data comparison not only solves the monitoring delay and error problems in the existing technology in principle, but also provides strong support for personalized medicine, which helps to improve the quality and efficiency of intensive care.

[0023] According to a preferred embodiment, the analysis unit can generate corresponding analysis results based on the degree of deviation between the pH value of the corresponding area of ​​the patient collected by the first pH sensor and the built-in theoretical data, and / or directly generate analysis results based on the comparison result of the pH value of the area where the expansion balloon on the endotracheal tube is located collected by the second pH sensor and a preset fixed value, wherein the analysis results include whether the patient has gastric reflux and the severity of the gastric reflux.

[0024] This method combines the pH change information at two different locations to form a multi-dimensional monitoring system. First, by analyzing the data collected by the first pH sensor, it is possible to preliminarily determine whether gastric juice has begun to reflux and evaluate its impact range in the upper respiratory tract. Then, with the help of the data from the second pH sensor, the analysis unit can directly detect the pH changes inside the trachea, especially when the pH value is lower than the preset fixed value, indicating that the gastric contents have refluxed into the airway and then been inhaled into the lungs. This double verification mechanism not only improves the accuracy of monitoring, but also distinguishes reflux events at different stages, providing clinicians with more detailed information on the progression of the disease. More importantly, by integrating information from multiple data sources, the device can identify the risk of gastric reflux earlier, issue an alarm in time, and give medical staff a valuable opportunity to intervene in advance, thereby effectively reducing aspiration and its serious complications, such as aspiration pneumonia or acute respiratory distress syndrome (ARDS). This method not only solves the limitations of existing monitoring methods from a technical level, but also provides a more scientific and efficient management tool for critical care, which helps to improve the prognosis of patients.

[0025] According to a preferred embodiment, the analysis unit can be integrated into a terminal device with a display unit, so that the data information received by the analysis unit and the analysis results generated based on the data information can be displayed to medical staff in a visual manner through the display unit.

[0026] This design not only simplifies the data analysis process, but also enables the monitoring results to be displayed in a visual way, which greatly facilitates the operation and interpretation of medical staff. Through the display unit, the data information received by the analysis unit and the analysis results generated based on these data can be intuitively presented to medical staff, so that they can understand the pH change trend of the patient and the meaning behind it at a glance. In addition, the terminal device can also be equipped with an operation unit for adjusting the equipment parameters to meet the personalized needs of different users. More importantly, the terminal device can also be equipped with an alarm unit to send out corresponding alarm signals according to the severity of gastric reflux at different levels, reminding medical staff to take timely action. This terminal device, which integrates display, operation and alarm functions, not only improves the overall performance of the monitoring system, but also enhances its practicality and user experience. In this way, medical staff can obtain more timely and accurate feedback, so as to more effectively manage and prevent gastric reflux and its related complications, and ultimately improve the quality of intensive care and the safety of patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 It is a hardware connection diagram of the gastric reflux prediction device provided by the present invention; Figure 2 It is a schematic diagram of the arrangement of a pH sensor on an oral cannula in one embodiment provided by the present invention; Figure 3 It is a schematic diagram of the arrangement of a pH sensor on an oral cannula in another embodiment provided by the present invention; Figure 4 It is a schematic diagram of the arrangement of the pH sensor provided by the present invention on the nasal cannula; Figure 5 It is a schematic diagram of the arrangement of the pH sensor provided by the present invention on the tracheotomy tube; Figure 6 It is a schematic diagram of the arrangement of the first pH sensor provided by the present invention on the oral cannula; Figure 7 It is a schematic diagram of the arrangement of the second pH sensor provided by the present invention on the oral cannula; Figure 8 is a schematic diagram of the layout position of the second pH sensor provided by the present invention in one embodiment; Fig. 9 is a schematic diagram of the layout position of a second pH sensor in another embodiment provided by the present invention; Fig.10 is a schematic diagram of a change curve of the first theoretical data of the area near the oral cavity provided by the present invention; Fig.11 is a schematic diagram of a variation curve of the second theoretical data of the area near the oral cavity provided by the present invention; Fig.12 It is a schematic diagram of the change curve of the actual pH value of the normal control group and the intensive care patients in the vicinity of the oral cavity provided by the present invention.

[0028] Reference numerals list 100: first pH value sensor; 110: data transmission line; 200: second pH value sensor; 300: terminal device; 310: analysis unit; 400: endotracheal cannula; 410: dilation balloon; 420: oral cannula; 430: nasal cannula; 440: tracheotomy tube. DETAILED DESCRIPTION

[0029] The following is a detailed description with reference to the accompanying drawings.

[0030] The present invention discloses a gastric reflux prediction device for mechanically ventilated patients, and the mechanically ventilated patients may particularly refer to intensive care patients. Mechanical ventilation refers to assisting or replacing the patient's spontaneous breathing function by using mechanical equipment. In the process of implementing mechanical ventilation, the doctor will select a suitable ventilation mode and parameter settings according to the specific conditions of the patient. Usually, this involves inserting a special catheter (called an endotracheal tube 400 or a tracheotomy tube 440) into the patient's airway to establish a safe airway passage. Subsequently, the endotracheal tube 400 connected to the ventilator can deliver air or other mixed gases (such as gases with a high oxygen content) to the lungs according to a preset frequency and tidal volume. Modern ventilators have a variety of ventilation modes, including controlled ventilation (completely controlled by the machine), assisted / controlled ventilation (combining the patient's spontaneous breathing with machine assistance), pressure support ventilation (providing additional pressure support only when the patient tries to breathe) and non-invasive positive pressure ventilation (providing ventilation support through masks, etc. without the need for endotracheal tube 400) to meet the needs of different conditions.

[0031] To reduce the risk of gastric reflux and its attendant aspiration in mechanically ventilated patients, Figure 1 As shown, the gastric reflux prediction device of the present invention is configured to include: a first pH sensor 100, used to measure the pH value of the patient's oral cavity or epiglottis area; a second pH sensor 200, used to measure the pH value of the area where the expansion balloon 410 on the endotracheal tube 400 is located; an analysis unit 310, used to receive the pH value collected by the above-mentioned pH sensor and analyze and process it.

[0032] Preferably, the first pH sensor 100 and the second pH sensor 200 can be made of materials with good biocompatibility and acid and alkali corrosion resistance, such as glass electrodes or ion-sensitive field effect transistors (ISFETs). These materials can ensure stability for long-term use without causing irritation to the patient. Preferably, the first pH sensor 100 and the second pH sensor 200 can have a fast response characteristic and can accurately measure pH changes within seconds so as to capture the occurrence of gastric reflux events in time. Preferably, the first pH sensor 100 and the second pH sensor 200 can have high sensitivity to detect small pH fluctuations, wherein the error range does not exceed ±0.1 pH units.

[0033] Preferably, the first pH sensor 100 and the second pH sensor 200 can transmit data in a wired and / or wireless manner. For example, for the first pH sensor 100 and the second pH sensor 200 disposed on the endotracheal tube 400, the data transmission line 110 can be drawn out of the patient's body by attaching or building it into the side wall of the endotracheal tube 400 and connected to the analysis unit 310. For another example, the first pH sensor 100 and the second pH sensor 200 can use low-power Bluetooth (BLE) or other short-range wireless communication protocols to achieve 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 patient's freedom of movement. Preferably, considering the electromagnetic interference problem in the intensive care environment, when using a wireless transmission method, the first pH sensor 100 and the second pH sensor 200 can have good shielding performance to ensure the quality of signal transmission. Preferably, the first pH sensor 100 and the second pH sensor 200 can have a built-in small memory so that data can be recorded even when the connection and / or transmission is interrupted to prevent the loss of important information.

[0034] Preferably, the first pH sensor 100 and the second pH sensor 200 may have an automatic calibration function, allowing the sensor to self-calibrate before each use or regularly, reducing the need for manual intervention. Preferably, the first pH sensor 100 and the second pH sensor 200 can be easily disassembled for cleaning and disinfection to comply with hospital infection control standards.

[0035] Preferably, the first pH sensor 100 can select different setting positions according to the type of endotracheal tube 400 used by the mechanically ventilated patient, wherein the type of endotracheal tube 400 used by the mechanically ventilated patient may include oral cannula 420, nasal cannula 430, tracheotomy tube 440, etc.

[0036] Preferably, if Figure 2 and Figure 3As shown, for a patient using an oral cannula 420, the oral cannula 420 enters from the patient's oral cavity, passes through the soft palate, epiglottis and other tissues, and then enters the trachea through the larynx, wherein the oral cannula 420 contacts the tongue, soft palate and other tissues after being inserted into the patient's oral cavity; then passes through the pharynx, contacts the posterior pharyngeal wall and epiglottis; then passes through the larynx, contacts the vocal cords and tracheal rings; finally reaches the trachea and contacts the tracheal wall. Preferably, an expansion balloon 410 for contacting the tracheal wall may be generally provided near the distal end of the oral cannula 420, which is generally located below the glottis to prevent gas leakage and foreign matter from entering the trachea. Further, when a mechanically ventilated patient uses an oral cannula 420, the first pH sensor 100 may be installed in the area where the tracheal cannula 400 is located in the patient's oral cavity or epiglottis. This is because the oral cannula 420 is directly inserted into the trachea through the oral cavity, and it will pass through the oral cavity and epiglottis area, and the gastric fluid reflux will also contact the back of the oral cavity and the epiglottis area. Therefore, these two positions can detect the presence of gastric fluid and provide more timely warnings, thereby effectively reducing the risk of aspiration and protecting lung health. Exemplarily, the first pH sensor 100 can be set on the outer wall of the tracheal cannula 400 (i.e., the oral cannula 420) in the area of ​​the patient's oral cavity or epiglottis to ensure close contact with the mucosa of the oral cavity or epiglottis area, and transmit data to the analysis unit 310 through the data transmission line 110 set in the tracheal cannula 400.

[0037] Preferably, if Figure 4As shown, for a patient using a nasal cannula 430, the nasal cannula 430 enters from the patient's nostrils, passes through the nasal vestibule, the nasal passage (including the inferior turbinate and the middle turbinate), then enters the pharynx through the nasopharynx, passes through the soft palate and the epiglottis, and finally reaches the trachea, wherein the nasal cannula 430 first passes through the nasal vestibule after being inserted into the patient's nostrils, and contacts the nasal hair and nasal mucosa; secondly, passes through the inferior turbinate and the middle turbinate, and contacts the nasal passage mucosa; then passes through the nasopharynx, contacts the nasopharyngeal mucosa; then passes through the pharynx, contacts the posterior pharyngeal wall and the epiglottis; then passes through the larynx, contacts the vocal cords and tracheal rings; finally reaches the trachea, contacts the tracheal wall. Preferably, an expansion balloon 410 for contacting the tracheal wall may be generally provided near the distal end of the nasal cannula 430, which is generally located below the glottis to prevent gas leakage and foreign matter from entering the trachea. Furthermore, when a mechanically ventilated patient uses a nasal cannula 430, the first pH sensor 100 can be installed in the area of ​​the tracheal cannula 400 located in the patient's epiglottis. This is because the nasal cannula 430 enters from the nasal cavity, bypasses the oral cavity and reaches the trachea directly. The epiglottis is where the respiratory tract and the digestive tract meet, and the vicinity is the first significant point where gastric juice reflux is most likely to contact. The first pH sensor 100 is set here, and the situation of gastric juice reflux reaching the pharynx can be detected as early as possible to provide an early warning, thereby reducing the risk of aspiration, and because the pH change in the epiglottis area is mainly caused by gastric juice, rather than other factors, the false alarm rate can be greatly reduced. Exemplarily, the first pH sensor 100 can be set on the outer wall of the tracheal cannula 400 (i.e., the nasal cannula 430) located in the patient's epiglottis to ensure close contact with the mucosa of the epiglottis area, and transmit the data to the analysis unit 310 through the data transmission line 110 set in the tracheal cannula 400.

[0038] Preferably, if Figure 5As shown, for patients using a tracheostomy tube 440, a tracheotomy is usually performed in the midline of the neck to form an incision that allows the tracheostomy tube 440 to be inserted, wherein the location of the tracheotomy is usually between the first and second cartilage rings below the thyroid cartilage (Aldren's apple). The incision is usually transverse or longitudinal to reduce the formation of postoperative scars. The incision first passes through the skin and enters the subcutaneous tissue layer, including subcutaneous fat and superficial fascia. The subcutaneous tissue layer is thin and easy to separate. Continuing downward, the incision passes through the muscle layer of the neck, including the platysma, sternocleidomastoid muscle, and infrahyoid muscles. These muscles are usually divided or cut to expose the trachea. The pretracheal fascia covering the front of the trachea is a thin layer of connective tissue that can be cut to expose the front wall of the trachea. The tracheotomy tube 440 is finally inserted into the trachea through the incision. Preferably, a dilation balloon 410 for contacting the tracheal wall may be generally provided near the distal end of the tracheotomy tube 440, which is generally located below the glottis to prevent gas leakage and foreign matter from entering the trachea. Further, since the tracheotomy tube 440 is directly connected to the lower trachea, generally located below the cricoid cartilage and far away from the starting point of the path of gastric fluid reflux, in this case, the first pH sensor 100 may not be provided.

[0039] Furthermore, in addition to being arranged on the endotracheal tube 400 at a position corresponding to the oral cavity or epiglottis area of ​​the patient, the first pH sensor 100 can also be integrated on medical equipment currently used or to be used by mechanically ventilated patients. For example, for patients using oral cannula 420, the first pH sensor 100 can be arranged on the tooth pad of the oral cannula 420 holder; or it can be configured as an independent device to be directly arranged at the corresponding position. Preferably, the arrangement position of the first pH sensor 100 is the first line of defense against gastric juice reflux into the upper respiratory tract, and therefore can best reflect the reflux situation.

[0040] Preferably, the second pH sensor 200 can be arranged in the area where the expansion balloon 410 on the endotracheal tube 400 is located to measure the pH value nearby, wherein the expansion balloon 410 (also called a cuff or balloon catheter) on the endotracheal tube 400 is located at the distal end of the tube, that is, close to the tip side. When the endotracheal tube 400 is correctly inserted into the patient's trachea, the expansion balloon 410 will be located in the trachea close to the tracheal wall. Furthermore, the expansion balloon 410 of the endotracheal tube 400 can form a sealed environment after inflation to prevent gas leakage and ensure that the tidal volume during mechanical ventilation can effectively enter the lungs.

[0041] Furthermore, the second pH sensor 200 can be arranged on the outer wall of the endotracheal tube 400 or on the expansion balloon 410, and can be arranged on the end surface (i.e., the upper end surface) of the expansion balloon 410 facing the patient's head. Regardless of being arranged on the outer wall of the endotracheal tube 400 or on the expansion balloon 410, the second pH sensor 200 is arranged closer to the patient's head than the expansion balloon 410 body.

[0042] Preferably, after determining the deployment area, the first pH sensor 100 and the second pH sensor 200 can be arranged at a position relatively closer to the esophagus in the current area. For example, if the first pH sensor 100 is arranged on the outer wall of the endotracheal tube 400 in the area of ​​the patient's mouth, it can be preferably arranged on the side of the outer wall of the endotracheal tube 400 in the area facing the patient's tongue, such as Figure 6 As shown; if the first pH sensor 100 is disposed on the outer wall of the endotracheal tube 400 located in the area of ​​the patient's epiglottis, it may be preferably disposed on the side of the outer wall of the endotracheal tube 400 located in the area facing the patient's back. For another example, Figure 7~Figure 9 As shown, the second pH sensor 200 can be arranged on the side of the endotracheal tube 400 near the outer wall of the expansion balloon 410 facing the patient's back, or on the upper end surface of the expansion balloon 410 near the patient's back, wherein, Figure 8 and Fig. 9 The two figures are cross-sectional views of a human body where the expansion balloon 410 is located, and the two figures respectively show different placement positions of the second pH sensor 200.

[0043] Preferably, the pH values ​​collected in real time by the first pH sensor 100 and the second pH sensor 200 can be sent to the analysis unit 310, so that the analysis unit 310 can monitor the pH value at one or more locations in the patient's body, thereby determining whether the patient has gastric reflux.

[0044] Preferably, after receiving the pH value of the patient's corresponding area (such as the oral cavity or the area near the epiglottis) collected by the first pH sensor 100, the analysis unit 310 can compare it with the theoretical data built into the analysis unit 310 to determine the degree of deviation of the real-time collected data. Preferably, the analysis unit 310 can construct and update corresponding theoretical data for patients with different basic information based on historical big data and / or prediction models, and the theoretical data is the change of the pH value of the patient's corresponding area over time. Preferably, the theoretical data may include first theoretical data and second theoretical data, wherein the first theoretical data is the ideal data of the pH value of the patient's corresponding area over time without interference from other additional factors; the second theoretical data is the corrected data obtained by correcting the above ideal data based on partially controllable nursing measures. Further, for the pH value near the oral cavity, since patients usually need to use weak acidic detergents for regular oral care every period of time (for example, 6 hours) to control bacteria, maintain oral humidity, and help stabilize the oral pH value, thereby preventing the pH value from continuously decreasing, the second theoretical data is usually different from the first theoretical data. As for the pH value near the epiglottis, since there are no nursing measures specifically for regulating and stabilizing the pH value near the epiglottis in current medical practice, its second theoretical data is usually equal to or approximately equal to its first theoretical data. However, if there are other nursing measures that indirectly affect the pH value near the epiglottis, its second theoretical data will not be equal to its first theoretical data.

[0045] For example, taking the pH value near the oral cavity of a certain type of patient as an example, the first theoretical data built into the analysis unit 310 can be as follows: Fig.10 As shown in the figure, its pH value gradually decreases from 7.0 to 6.2, and the rate of decrease is most obvious in the first 12 to 24 hours. After 72 hours, the pH value tends to stabilize but is still at a low level. Based on this, medical staff can use weak acid cleaners to perform regular oral care every 6 hours to control and adjust its pH value to obtain the following Fig.11 The second theoretical data is shown. Fig.12 As shown in the figure, although the pH value will drop sharply when the patient has gastric reflux, the fluctuation range of the pH value of intensive care patients is significantly greater than that of the normal control group. Therefore, it is necessary to more accurately judge whether gastric reflux has really occurred by comparing with the second theoretical data. Fig.12As shown, the pH value of the normal control group changed very little, and its fluctuation range was basically maintained at 6.9~7.1, while the pH value of the intensive care patients dropped to 6.5 at the 6-hour node, which was a pH change caused by oral care; it dropped sharply to 6.2 at the 12-hour node, which was a sharp drop in pH caused by gastric reflux; it rebounded to 6.7 at the 18-hour node, which was a pH change caused by oral care; and it dropped again to 6.3 at the 24-hour node, which was a sharp drop in pH caused by gastric reflux.

[0046] Preferably, the analysis unit 310 can generate corresponding analysis results based on the degree of deviation between the pH value of the corresponding area of ​​the patient (such as the oral cavity or the area near the epiglottis) collected by the first pH sensor 100 and the built-in theoretical data (i.e., the first theoretical data and / or the second theoretical data), wherein the analysis results may include whether the patient has experienced gastric reflux and the severity of the gastric reflux. Preferably, after excluding the influence of some controllable nursing measures on the pH value of the corresponding area, if the change rate of adjacent nodes exceeds the preset threshold, the analysis unit 310 can identify the relatively backward nodes as having experienced gastric reflux, and can determine the severity of its gastric reflux according to the range of its corresponding change rate.

[0047] Preferably, the analysis unit 310 can determine whether gastric juice aspiration occurs based on the comparison result between the pH value of the area where the expansion balloon 410 on the endotracheal tube 400 is located collected by the second pH sensor 200 and the preset fixed value, wherein when the pH value collected by the second pH sensor 200 is lower than the preset fixed value, it indicates that there is a process in which the gastric contents reflux into the airway and are then inhaled into the lungs. Gastric juice aspiration is a serious medical problem because it may lead to a series 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, the corresponding analysis result can be directly generated, wherein the severity of gastric juice reflux in the analysis result can be set to the highest. In other words, at this time, the severity of gastric reflux does not need to be determined based on the degree of deviation between the pH value of the corresponding area of ​​the patient collected by the first pH sensor 100 and the built-in theoretical data. However, if the analysis unit 310 determines that the patient has not experienced gastric reflux based on the degree of deviation between the pH value of the corresponding area of ​​the patient collected by the first pH sensor 100 and the built-in theoretical data, it is necessary to eliminate interference from other factors such as equipment failure (such as sensor failure, communication failure) to ensure the accuracy of data collection and analysis.

[0048] Preferably, the endotracheal tube 400 for mechanical ventilation can adopt a double-lumen catheter design, wherein the double-lumen catheter can include a gas channel and a suction channel, the gas channel is used to maintain the gas delivery function of the existing endotracheal tube 400, ensuring that oxygen and other mixed gases can smoothly enter the lungs according to preset parameters, and the suction channel can be located on the side or inner layer of the gas channel in the endotracheal tube 400, and isolated from the endotracheal tube 400, so that when the suction channel is directly connected to the negative pressure suction device, it can extract the refluxed or aspirated gastric juice without interfering with the gas passage. The suction channel can adopt a spiral shape or other optimized shape to reduce the occupation of the airway space and prevent blockage. Preferably, the suction channel can be provided with a suction port in a part of the endotracheal tube 400, wherein the opening position of the suction port is associated with the layout position of the pH sensor, that is, the opening position of the suction port is located near the layout position of the pH sensor, so that when the corresponding pH sensor monitors that the patient has reflux or aspiration, the corresponding area can be suctioned in a targeted manner. For example, the suction port can be opened at a position of the endotracheal tube 400 located near the patient's mouth, epiglottis, or trachea, wherein the position near the patient's trachea can particularly refer to a position located above the dilation balloon 410 .

[0049] By setting the suction port in a key area near the pH sensor, such as the oral cavity, epiglottis or trachea (especially the area above the dilation balloon 410), the device can immediately start the suction procedure when gastric fluid reflux or aspiration is detected, directly acting on the specific affected part. This method not only improves the accuracy and efficiency of suction, but also can quickly remove the locally accumulated gastric fluid, effectively reducing the risk of serious complications caused by aspiration. Compared with traditional methods, this targeted suction mechanism greatly reduces the possibility of further spread of aspirated materials, thereby better protecting the patient's respiratory tract from damage. In addition, the design of the double-lumen catheter ensures the complete separation of gas delivery and liquid extraction processes, so that respiratory support is not affected and a stable gas exchange environment is maintained. This feature is particularly important for critically ill patients because it ensures that the necessary oxygen supply can be continuously provided even in an emergency, avoiding respiratory interruption or instability caused by suction operations. From the perspective of clinical application, this improvement greatly simplifies the operating procedures of medical staff, reduces the additional burden caused by dealing with reflux or aspiration events, and provides a more intuitive feedback mechanism to help them make correct decisions in a timely manner. For patients, this design can respond to situations of gastric reflux or aspiration in the shortest possible time, minimize potential harm, and significantly improve the quality of prognosis.

[0050] Preferably, after a patient experiences gastric reflux or aspiration, after countermeasures are automatically implemented or manually implemented by medical staff, when the pH value of the corresponding area of ​​the pH sensor returns to the normal range, the analysis unit 310 can reset the theoretical data, use the current moment as the new starting moment, and re-predict and compare, thereby improving the accuracy of the prediction.

[0051] Preferably, the analysis unit 310 can be integrated into a terminal device 300 with a display unit, so that the data information received by the analysis unit 310 and the analysis results generated based on the data information can be displayed to medical staff in a visual manner through the display unit, so that the medical staff can intuitively understand the situation of gastric reflux in the patient. Preferably, an operating unit can be provided on the terminal device 300 to adjust the parameters of the terminal device 300 itself and / or the sensor connected to the terminal device 300, so as to meet the usage habits of different users. Preferably, an alarm unit can be provided on the terminal device 300, so that when the analysis unit 310 determines that the patient has gastric reflux based on the analysis results generated by it, different alarm signals can be issued according to the severity of the current gastric reflux, so as to remind medical staff to deal with it in time.

[0052] It should be noted that the above-mentioned specific embodiments are exemplary, and those skilled in the art can come up with various solutions inspired by the disclosure of the present invention, and these solutions also belong to the disclosure scope of the present invention and fall within the protection scope of the present invention. Those skilled in the art should understand that the present invention specification and its drawings are illustrative and do not constitute a limitation of the claims. The scope of protection of the present invention is defined by the claims and their equivalents. The present invention specification contains multiple inventive concepts, such as "preferably" or "according to a preferred embodiment", which means that the corresponding paragraph discloses an independent concept, and the applicant reserves the right to file a divisional application based on each inventive concept. Throughout the text, the features guided by "preferably" are only an optional method and should not be understood as a must-have setting. Therefore, the applicant reserves the right to abandon or delete the relevant preferred features at any time.

Claims

1. A gastric reflux prediction device for mechanically ventilated patients, characterized in that: It includes: A first pH sensor (100) for measuring the pH value of the oral cavity or epiglottis area of ​​a patient; A second pH sensor (200) for measuring the pH value of the area where the expansion balloon (410) on the endotracheal tube (400) is located; The analysis unit (310) is used to receive the pH value collected by the pH sensor and analyze and process it. The analysis unit (310) is configured to: determining the change in pH value over time in the oral cavity or epiglottis area of ​​the patient according to the pH value provided by the first pH value sensor (100); The change of the pH value of the upper end of the expansion balloon (410) over time is determined according to the pH value provided by the second pH value sensor (200), wherein: The dilation balloon (410) on the endotracheal tube (400) can be placed in the patient's trachea and in contact with the tracheal wall.

2. The 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 performing data transmission via wired and / or wireless means, wherein, when performing wired transmission, the data transmission line (110) of the first pH sensor (100) and / or the second pH sensor (200) can be led out of the patient's body in a manner of being attached to or built into the side wall of the endotracheal tube (400) and connected to the analysis unit (310).

3. The gastric reflux prediction device according to claim 1 or 2, characterized in that: The first pH sensor (100) and the second pH sensor (200) can be arranged in a corresponding arrangement area at a position relatively closer to the esophagus in the current area, wherein the first pH sensor (100) can select different arrangement positions according to the type of endotracheal tube (400) used by the mechanically ventilated patient, and the type of endotracheal tube (400) used by the mechanically ventilated patient includes an oral cannula (420), a nasal cannula (430), and a tracheotomy tube (440).

4. The gastric reflux prediction device according to claim 3, characterized in that: For patients whose endotracheal tube (400) is an oral tube (420), the first pH sensor (100) can be arranged on the outer wall of the endotracheal tube (400) in the area of ​​the patient's oral cavity or epiglottis, wherein if the first pH sensor (100) is arranged on the outer wall of the endotracheal tube (400) in the area of ​​the patient's oral cavity, it is arranged on the side of the outer wall of the endotracheal tube (400) in this area facing the patient's tongue; if the first pH sensor (100) is arranged on the outer wall of the endotracheal tube (400) in the area of ​​the patient's epiglottis, it is arranged on the side of the outer wall of the endotracheal tube (400) in this area facing the patient's back.

5. The gastric reflux prediction device according to claim 3, characterized in that: For patients whose endotracheal tube (400) is a nasal tube (430), the first pH sensor (100) can be arranged on the outer wall of the endotracheal tube (400) located in the area of ​​the patient's epiglottis, and on the side of the outer wall of the endotracheal tube (400) located in this area facing the patient's back.

6. The gastric reflux prediction device according to claim 3, characterized in that: For patients whose endotracheal tube (400) is a tracheotomy tube (440), the first pH value sensor (100) is not provided, and the second pH value sensor (200) is only provided in the area where the expansion balloon (410) on the endotracheal tube (400) is located.

7. The gastric reflux prediction device according to claim 3, characterized in that: The second pH value sensor (200) can be arranged on the outer wall of the endotracheal tube (400) or on the upper end surface of the expansion balloon (410), wherein when the second pH value sensor (200) is arranged on the outer wall of the endotracheal tube (400), it can be arranged on the side of the outer wall of the endotracheal tube (400) close to the expansion balloon (410) facing the patient's back; when the second pH value sensor (200) is arranged on the upper end surface of the expansion balloon (410), it can be arranged at a local position on the upper end surface of the expansion balloon (410) close to the patient's back.

8. The gastric reflux prediction device according to claim 1, characterized in that: After receiving the pH value of the patient's corresponding area collected by the first pH sensor (100), the analysis unit (310) can compare it with the theoretical data built into the analysis unit (310) to determine the degree of deviation of the real-time collected data, wherein the theoretical data includes first theoretical data and second theoretical data, the first theoretical data being ideal data of the pH value of the patient's corresponding area changing over time in the absence of interference from other additional factors; the second theoretical data being corrected data obtained by correcting the above ideal data based on partially controllable nursing measures.

9. The gastric reflux prediction device according to claim 8, characterized in that: The analysis unit (310) is capable of generating corresponding analysis results based on the degree of deviation between the pH value of the corresponding area of ​​the patient collected by the first pH sensor (100) and the built-in theoretical data, and / or directly generating analysis results based on the comparison result of the pH value of the area where the expansion balloon (410) on the endotracheal tube (400) is located collected by the second pH sensor (200) and a preset fixed value, wherein the analysis results include whether the patient has experienced gastric reflux and the severity of the gastric reflux.

10. The gastric reflux prediction device according to claim 1, characterized in that: The analysis unit (310) can be integrated into a terminal device (300) with a display unit, so that the data information received by the analysis unit (310) and the analysis results generated based on the data information can be displayed to medical staff in a visual manner through the display unit.

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