A gastric reflux prediction device for patients undergoing mechanical ventilation

Abstract

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

[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 involves the use of a mechanical device to assist or replace a patient's spontaneous breathing function. When a patient is unable to maintain adequate gas exchange due to various reasons (such as acute respiratory distress syndrome, acute exacerbations of chronic obstructive pulmonary disease, neuromuscular diseases, severe trauma, or postoperative recovery), mechanical ventilation can provide the necessary support, ensuring adequate oxygen delivery to the blood and efficient removal of carbon dioxide. This process not only helps stabilize the patient's respiratory status but also buys time to treat the underlying cause.

[0003] In critical care settings, mechanically ventilated patients are often at risk for a range of complications, one of which is gastric reflux. Because these patients are often sedated or comatose and require prolonged bed rest, coupled with the effects of mechanical ventilation itself, they are more susceptible to reflux of gastric contents. This condition not only increases the risk of aspiration, potentially leading to serious complications such as aspiration pneumonia, but can also compromise the effectiveness of mechanical ventilation and the patient's recovery process.

[0004] Mechanical ventilation maintains the patient's respiratory function through artificial means. When the endotracheal tube is inserted, an inflatable balloon is placed to seal the airway to ensure that gas does not leak and to 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 an inflammatory response in the alveoli, 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, and 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, including 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 drainage port provided in the linear groove; one end of the pH sensor signal transmission line and the temperature sensor signal transmission line provided 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 multi-functional signal processing display.

[0007] Gastric reflux and the associated risk of aspiration pose a significant and pressing problem in the critical care of mechanically ventilated patients. 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 subsequent testing, which is not only time-consuming but also lacks immediate data feedback, resulting in healthcare providers only receiving results some time after the event. This delay makes it difficult to implement timely preventive or intervention measures, increasing the risk of serious complications from aspiration, such as aspiration pneumonia and acute respiratory distress syndrome (ARDS). Another significant issue is the lack of early warning capabilities for gastric reflux. Because gastric reflux often occurs suddenly and without obvious warning signs, especially when the patient is sedated or comatose, protective reflexes are weakened or absent. This makes it difficult for traditional monitoring methods to detect and prevent aspiration in advance. Without an effective early warning mechanism, healthcare providers are forced to passively respond to reflux events rather than proactively prevent them, posing 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 some of the above technical problems.

[0010] The present invention discloses a gastric reflux prediction device for mechanically ventilated patients, comprising: 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.

[0011] The gastric reflux prediction device of the present invention utilizes a first pH sensor and a second pH sensor to measure pH values ​​in the patient's oral cavity or epiglottis, as well as in the area surrounding the endotracheal tube's expansion balloon. Combined with an analysis unit, this data is processed, providing a novel solution to the technical challenge of real-time monitoring of gastric reflux. The device enables real-time, continuous monitoring of pH changes at key locations, allowing rapid detection of gastric reflux. When gastric fluid refluxes into these areas, its acidic nature causes a significant drop in local pH, a change that is promptly detected by the pH sensors and transmitted to the analysis unit. The analysis unit then conducts in-depth analysis of pH changes over time to accurately determine the specific nature of the gastric reflux. This approach not only improves monitoring sensitivity and accuracy but also enables healthcare professionals to take preventative measures immediately, effectively reducing the risk of aspiration and the resulting serious complications, such as aspiration pneumonia or acute respiratory distress syndrome (ARDS). Furthermore, by precisely monitoring pH changes at different locations, the device can help identify reflux pathways, providing a scientific basis for developing personalized treatment plans.

[0012] According to a preferred embodiment, the first pH sensor and the second pH sensor can transmit data 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 by being attached to or built into the side wall of the endotracheal tube and connected to the analysis unit.

[0013] The first and second pH sensors can be connected to the analysis unit via either wired or wireless connections, greatly enhancing the system's flexibility and practicality. When using wired transmission, the sensor data lines can be attached to or embedded within the side of the endotracheal tube, ensuring stable signal transmission while reducing reliance on the external environment and minimizing the risk of electromagnetic interference. This wiring method not only ensures real-time data integrity but also avoids the potential for physical damage or infection caused by exposed wiring. In the case of wireless transmission, the use of short-range communication protocols such as Bluetooth Low Energy (BLE) allows for efficient data exchange between sensors without affecting the patient's freedom of movement. This approach not only simplifies device installation but also improves patient comfort, especially in settings requiring frequent repositioning. Regardless of the transmission method chosen, this design ensures reliable data transmission, allowing healthcare professionals to continuously monitor changes in the patient's pH level, enabling earlier detection of potential gastric reflux issues and appropriate interventions, thereby improving patient safety and treatment outcomes.

[0014] According to a preferred embodiment, the first pH sensor and the second pH sensor can be set at 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 tracheal intubation used by mechanically ventilated patients, and the types of tracheal intubation used by mechanically ventilated patients include oral intubation, nasal intubation, and tracheotomy tube.

[0015] The first and second pH sensors can be positioned closer to the esophagus within their respective deployment areas, helping to more accurately detect early signs of gastric reflux. Especially for patients intubated with oral, nasal, or tracheostomy tubes, selecting different sensor placements based on the specific tube type maximizes the effectiveness of each sensor. For example, in the case of oral intubation, placing the first pH sensor on the outer wall of the tracheal tube in the oral or epiglottal area directly monitors gastric reflux reaching the pharynx. For nasal intubation, the first pH sensor is positioned near the epiglottis for earliest detection of gastric reflux. This layout design not only takes anatomical rationality into account but also reflects the need for personalized care for patients with different types of intubation. This targeted sensor configuration allows the device to respond immediately to gastric reflux, providing an immediate warning, reducing the possibility of aspiration, and providing a valuable window for subsequent intervention. This positioning strategy leverages anatomical features, enabling closer sensor contact with the target mucosa, thereby improving the accuracy and sensitivity of pH measurements. 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 issue 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 respiratory safety.

[0016] According to a preferred embodiment, for patients whose endotracheal tube is an oral tube, the first pH sensor can be set on the outer wall of the endotracheal tube in the area of ​​the patient's mouth or epiglottis, wherein, if the first pH sensor is set on the outer wall of the endotracheal tube in the area of ​​the patient's mouth, it is set 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 set on the outer wall of the endotracheal tube in the area of ​​the patient's epiglottis, it is set 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 tube is a nasal tube, the first pH sensor can be arranged on the outer wall of the endotracheal tube in the area of ​​the patient's epiglottis, and on the side of the outer wall of the endotracheal tube 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 provided only at 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 sensor's operating environment and performance requirements. Placing the second pH sensor on the outer wall of the endotracheal tube, near the dilation cuff, ensures its close proximity to the tracheal wall, enabling better sensing of pH changes caused by gastric reflux. When the sensor is positioned above the dilation cuff, it directly monitors the pH conditions in the area above the cuff, providing the last line of defense against aspiration of gastric fluid into the lungs. This carefully designed arrangement enables the second pH sensor to react instantly to gastric reflux, providing an immediate warning. Furthermore, the sensor's high sensitivity and rapid response enable it to detect minute pH fluctuations, enabling accurate detection even with low reflux volumes. This arrangement not only improves monitoring sensitivity and accuracy but also provides clinicians with more detailed pathological information, enabling them to identify potential problems earlier and initiate appropriate interventions, effectively reducing the risk of aspiration and protecting patients' lives and health.

[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 influence 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 existing technologies 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 tracheal tube is located collected by the second pH sensor and the preset fixed value, wherein the analysis results include whether the patient has experienced gastric reflux and the severity of the gastric reflux.

[0024] This approach combines pH changes from two different locations to form a multi-dimensional monitoring system. First, by analyzing data collected by the first pH sensor, it can preliminarily determine whether gastric reflux has begun and assess its impact on the upper respiratory tract. Then, using data from the second pH sensor, the analysis unit can directly detect pH changes within the trachea. Specifically, when the pH falls below a preset fixed value, it indicates that gastric contents have refluxed into the airways and subsequently been aspirated into the lungs. This dual verification mechanism not only improves monitoring accuracy but also distinguishes between different stages of reflux events, providing clinicians with more detailed information on the progression of the disease. Importantly, by integrating information from multiple data sources, the device can identify the risk of gastric reflux earlier, issuing a timely alarm and providing medical staff with a valuable opportunity for preemptive intervention, thereby effectively reducing aspiration and its associated serious complications, such as aspiration pneumonia or acute respiratory distress syndrome (ARDS). This approach not only addresses the technical limitations of existing monitoring methods but also provides a more scientific and efficient management tool for critical care, helping to improve patient outcomes.

[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 a visual display of monitoring results, greatly facilitating operation and interpretation by medical staff. The display unit intuitively presents the data received by the analysis unit and the analysis results generated based on this data to medical staff, allowing them to clearly understand the patient's pH trend and its underlying significance. Furthermore, the terminal device can be equipped with an operation unit for adjusting device parameters to meet the personalized needs of different users. More importantly, the terminal device can also be equipped with an alarm unit that issues alarm signals based on the severity of gastric reflux, prompting medical staff to take timely action. This integrated display, operation, and alarm function not only improves the overall performance of the monitoring system, but also enhances its practicality and user experience. This approach allows medical staff to obtain more timely and accurate feedback, enabling more effective management and prevention of gastric reflux and its related complications, ultimately improving the quality of intensive care and patient safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 This is a hardware connection diagram of the gastric reflux prediction device provided by the present invention;

[0028] Figure 2 Schematic diagram of the arrangement of a pH sensor on an oral cannula in one embodiment of the present invention;

[0029] Figure 3 Schematic diagram of the arrangement of a pH sensor on an oral cannula in another embodiment provided by the present invention;

[0030] Figure 4 This is a schematic diagram of the arrangement of the pH sensor provided by the present invention on a nasal cannula;

[0031] Figure 5 This is a schematic diagram of the arrangement of the pH sensor provided by the present invention on a tracheotomy tube;

[0032] Figure 6 This is a schematic diagram of the arrangement of the first pH sensor provided by the present invention on the oral cannula;

[0033] Figure 7 This is a schematic diagram of the arrangement of the second pH sensor provided by the present invention on the oral cannula;

[0034] Figure 8 This is a schematic diagram of the layout position of the second pH sensor provided by the present invention in one embodiment;

[0035] Figure 9 This is a schematic diagram of the layout position of a second pH sensor in another embodiment provided by the present invention;

[0036] Figure 10 This 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;

[0037] Figure 11 2 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;

[0038] Figure 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 area near the oral cavity provided by the present invention.

[0039] Reference Signs List

[0040] 100: First pH sensor; 110: Data transmission line; 200: Second pH sensor; 300: Terminal device; 310: Analysis unit; 400: Endotracheal tube; 410: Dilation balloon; 420: Oral tube; 430: Nasal tube; 440: Tracheotomy tube. DETAILED DESCRIPTION

[0041] The following is a detailed description with reference to the accompanying drawings.

[0042] The present invention discloses a gastric reflux prediction device for mechanically ventilated patients, particularly those in intensive care units. Mechanical ventilation refers to the use of mechanical equipment to assist or replace a patient's spontaneous breathing function. During mechanical ventilation, the physician selects the appropriate ventilation mode and parameter settings based on the patient's specific condition. Typically, this involves inserting a specialized tube (called an endotracheal tube 400 or a tracheostomy tube 440) into the patient's airway to establish a secure airway. The endotracheal tube 400, connected to a ventilator, then delivers air or other mixed gases (such as those with a high oxygen content) to the lungs at a preset rate and tidal volume. Modern ventilators offer a variety of ventilation modes, including controlled ventilation (completely controlled by the machine), assisted / controlled ventilation (a combination of spontaneous breathing and machine assistance), pressure support ventilation (providing additional pressure support only when the patient attempts to breathe), and non-invasive positive pressure ventilation (providing ventilation support through a mask or other means without the need for an endotracheal tube 400), to accommodate the needs of different conditions.

[0043] To reduce the risk of gastric reflux and its associated 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; and an analysis unit 310, used to receive the pH value collected by the above-mentioned pH sensor and analyze and process it.

[0044] Preferably, the first pH sensor 100 and the second pH sensor 200 can be manufactured using materials with good biocompatibility and resistance to acid and alkali corrosion, such as glass electrodes or ion-sensitive field-effect transistors (ISFETs). These materials ensure long-term stability while not causing irritation to the patient. Preferably, the first pH sensor 100 and the second pH sensor 200 have fast response characteristics, accurately measuring pH changes within seconds to promptly detect gastric reflux events. Preferably, the first pH sensor 100 and the second pH sensor 200 have high sensitivity to detect even small pH fluctuations, with an error range of no more than ±0.1 pH units.

[0045] Preferably, the first pH sensor 100 and the second pH sensor 200 can transmit data via wired and / or wireless means. For example, for the first pH sensor 100 and the second pH sensor 200 installed on the endotracheal tube 400, the data transmission line 110 can be attached to or built into the side wall of the endotracheal tube 400, leading out of the patient's body and connected to the analysis unit 310. For another example, the first pH sensor 100 and the second pH sensor 200 can utilize Bluetooth Low Energy (BLE) or other short-range wireless communication protocols to enable data exchange with the analysis unit 310, ensuring real-time data transmission to the analysis unit 310 without affecting the patient's freedom of movement. To address electromagnetic interference issues in intensive care environments, when using wireless transmission, the first pH sensor 100 and the second pH sensor 200 should preferably have good shielding properties to ensure signal transmission quality. Preferably, the first pH sensor 100 and the second pH sensor 200 can include a built-in small memory to record data even in the event of connection and / or transmission interruptions, preventing the loss of important information.

[0046] Preferably, the first pH sensor 100 and the second pH sensor 200 can have an automatic calibration function, allowing the sensors to self-calibrate before each use or periodically, 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.

[0047] Preferably, the first pH sensor 100 can be set at different locations 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.

[0048] Preferably, if Figure 2 and Figure 3 As shown, for a patient using an oral intubation tube 420, the oral intubation tube 420 enters the patient's oral cavity, passes through tissues such as the soft palate and epiglottis, and then enters the trachea through the larynx. After being inserted into the patient's oral cavity, the oral intubation tube 420 contacts tissues such as the tongue and soft palate; then passes through the pharynx, contacts the posterior pharyngeal wall and epiglottis; then passes through the larynx, contacts the vocal cords and tracheal rings; and finally reaches the trachea and contacts the tracheal wall. Preferably, an expansion balloon 410 for contacting the tracheal wall may be provided near the distal end of the oral intubation tube 420, which is typically located below the glottis to prevent gas leakage and foreign matter from entering the trachea. Furthermore, when a mechanically ventilated patient uses an oral intubation tube 420, the first pH sensor 100 may be installed in the area of ​​the tracheal intubation tube 400 located in the patient's oral cavity or epiglottis. This is because oral cannula 420 is inserted directly into the trachea through the mouth, passing through the oral cavity and epiglottis. Gastric reflux also contacts the back of the mouth and epiglottis. Therefore, these two locations can detect the presence of gastric fluid, providing a more timely warning, thereby effectively reducing the risk of aspiration and protecting lung health. For example, first pH sensor 100 can be disposed on the outer wall of endotracheal cannula 400 (i.e., oral cannula 420) in the area of ​​the patient's oral cavity or epiglottis, ensuring close contact with the mucosa of the oral cavity or epiglottis. The first pH sensor 100 transmits data to analysis unit 310 via data transmission line 110 disposed within endotracheal cannula 400.

[0049] Preferably, if Figure 4As shown, for a patient using a nasal cannula 430, the nasal cannula 430 enters the patient's nostril, passes through the nasal vestibule, nasal passage (including the inferior and middle turbinate), then enters the pharynx through the nasopharynx, passes through the soft palate and epiglottis, and finally reaches the trachea. After being inserted into the patient's nostril, the nasal cannula 430 first passes through the nasal vestibule and comes into contact with the nasal hairs and nasal mucosa; then passes through the inferior and middle turbinate and comes into contact with the nasal passage mucosa; then passes through the nasopharynx and comes into contact with the nasopharyngeal mucosa; then passes through the pharynx and comes into contact with the posterior pharyngeal wall and epiglottis; then passes through the larynx and comes into contact with the vocal cords and tracheal rings; and finally reaches the trachea and comes into contact with 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 on the endotracheal cannula 400 in the area of ​​the patient's epiglottis. This is because the nasal cannula 430 enters the nasal cavity, bypassing the oral cavity and reaching the trachea directly. The epiglottis is where the respiratory and digestive tracts meet, and its vicinity is the first significant point of contact for gastric reflux. Placing the first pH sensor 100 there can detect gastric reflux reaching the pharynx, providing an early warning and reducing the risk of aspiration. Furthermore, since pH changes in the epiglottis are primarily caused by gastric fluid, rather than other factors, false alarm rates can be significantly reduced. For example, the first pH sensor 100 can be installed on the outer wall of the endotracheal cannula 400 (i.e., the nasal cannula 430) in the area of ​​the patient's epiglottis, ensuring close contact with the epiglottis mucosa. The first pH sensor 100 transmits data to the analysis unit 310 via the data transmission line 110 provided within the endotracheal cannula 400.

[0050] Preferably, if Figure 5As shown, for patients requiring a tracheostomy tube 440, a tracheotomy is typically performed in the midline of the neck to create an incision to allow for insertion of the tube. The incision is typically made between the first and second cartilage rings below the thyroid cartilage (Adam's apple). The incision is typically transverse or longitudinal to minimize postoperative scarring. The incision is initially made through the skin into the subcutaneous tissue layer, which includes subcutaneous fat and superficial fascia. The subcutaneous tissue layer is thin and easily dissected. Continuing downward, the incision passes through the muscles of the neck, including the platysma, sternocleidomastoid, and infrahyoid muscles. These muscles are typically divided or incised to expose the trachea. The pretracheal fascia, a thin layer of connective tissue covering the front of the trachea, is incised to expose the anterior wall of the trachea. Tracheotomy tube 440 is ultimately inserted into the trachea through the incision. Preferably, a dilation balloon 410 is typically positioned near the distal end of tracheotomy tube 440 to contact the tracheal wall, typically located below the glottis, to prevent gas leakage and foreign matter from entering the trachea. Furthermore, since tracheotomy tube 440 is directly connected to the lower trachea, typically below the cricoid cartilage and away from the starting point of gastric reflux, the first pH sensor 100 may not be required.

[0051] Furthermore, in addition to being installed on the endotracheal tube 400 at a location corresponding to the patient's oral cavity or epiglottis, the first pH sensor 100 can also be integrated with medical equipment currently used or planned to be used by mechanically ventilated patients. For example, for patients using an oral tube 420, the first pH sensor 100 can be installed on the bite block of the oral tube 420 holder; or it can be configured as a standalone device and directly installed at the corresponding location. Preferably, the first pH sensor 100 is installed at the first line of defense against gastric fluid reflux into the upper respiratory tract, so it can best reflect reflux conditions.

[0052] Preferably, the second pH sensor 200 can be positioned in the area of ​​the dilation balloon 410 on the endotracheal tube 400 to measure the pH value nearby. The dilation balloon 410 (also known as a cuff or balloon catheter) on the endotracheal tube 400 is located at the distal end of the tube, near the tip. When the endotracheal tube 400 is properly inserted into the patient's trachea, the dilation balloon 410 is positioned within the trachea, closely adjacent to the tracheal wall. Furthermore, when inflated, the dilation balloon 410 of the endotracheal tube 400 creates a sealed environment, preventing gas leakage and ensuring that tidal volume during mechanical ventilation can effectively enter the lungs.

[0053] Furthermore, in addition to being mounted on the outer wall of the endotracheal tube 400, the second pH sensor 200 can also be mounted on the expansion balloon 410, and in particular, on the end surface (i.e., the upper end surface) of the expansion balloon 410 facing the patient's head. Regardless of whether the second pH sensor 200 is mounted on the outer wall of the endotracheal tube 400 or the expansion balloon 410, it is positioned closer to the patient's head than the expansion balloon 410 itself.

[0054] Preferably, after determining the placement area, the first pH sensor 100 and the second pH sensor 200 can be placed at a position relatively closer to the esophagus in the current area. For example, if the first pH sensor 100 is placed on the outer wall of the endotracheal tube 400 in the area where the patient's mouth is located, it can be preferably placed on the side of the outer wall of the endotracheal tube 400 in the area facing the patient's tongue, such as Figure 6 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. Figures 7 to 9 As shown, the second pH sensor 200 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, or on the upper end surface of the expansion balloon 410 at a local position close to the patient's back, wherein, Figure 8 and Figure 9 The two figures are cross-sectional views of the human body where the expansion balloon 410 is located. The two figures respectively show different placement positions of the second pH sensor 200.

[0055] 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 values ​​at one or more locations in the patient's body, thereby determining whether the patient has gastric reflux.

[0056] Preferably, after receiving the pH value of a 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 theoretical data stored in the analysis unit 310 to determine the degree of deviation in the real-time collected data. Preferably, the analysis unit 310 can construct and update corresponding theoretical data based on historical big data and / or predictive models for patients with different basic information. This theoretical data represents the time-dependent pH change of the patient's corresponding area. Preferably, this theoretical data may include first theoretical data and second theoretical data. The first theoretical data represents idealized pH value changes over time for the patient's corresponding area, assuming no interference from other factors. The second theoretical data represents corrected data obtained by correcting the idealized data based on some controllable oral care measures. Furthermore, regarding pH values ​​near the oral cavity, since patients typically require regular oral care with a weak acidic cleanser every six hours (e.g., to control bacteria, maintain oral moisture, and help stabilize oral pH to prevent a continuous pH drop), the second theoretical data is typically different from the first theoretical data. As for the pH value near the epiglottis, since there are no nursing measures specifically designed to regulate and stabilize the pH value near the epiglottis in current medical practice, its second theoretical value is usually equal to or approximately equal to its first theoretical value. However, if other nursing measures indirectly affect the pH value near the epiglottis, its second theoretical value will not be equal to its first theoretical value.

[0057] 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: Figure 10 As shown in the figure, the pH value gradually decreases from 7.0 to 6.2, with the rate of decrease being most obvious in the first 12 to 24 hours. After 72 hours, the pH value tends to stabilize but remains at a low level. Based on this, medical staff can perform regular oral care using a weak acidic detergent every 6 hours to control and adjust the pH value to obtain the following results: Figure 11 The second theoretical data shown. Figure 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, so it is necessary to more accurately judge whether gastric reflux has actually occurred by comparing with the second theoretical data. Figure 12As shown in the figure, 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 the pH value change caused by oral care; it dropped sharply to 6.2 at the 12-hour node, which was the sharp drop in pH value caused by gastric reflux; it rebounded to 6.7 at the 18-hour node, which was the pH value change caused by oral care; and it dropped again to 6.3 at the 24-hour node, which was the sharp drop in pH value caused by gastric reflux.

[0058] 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 impact of some controllable nursing measures on the pH value of the corresponding area, if the change rate of adjacent nodes exceeds a preset threshold, the analysis unit 310 may identify the relatively backward node as having experienced gastric reflux, and may determine the severity of the gastric reflux based on the range of its corresponding change rate.

[0059] Preferably, the analysis unit 310 can determine whether gastric aspiration has occurred based on a comparison of the pH value in the area of ​​the expansion balloon 410 on the endotracheal tube 400, as collected by the second pH sensor 200, with a preset fixed value. When the pH value collected by the second pH sensor 200 is lower than the preset fixed value, it indicates that gastric contents are refluxing into the airway and subsequently being aspirated into the lungs. Gastric aspiration is a serious medical problem because it can lead to a range 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, it can directly generate a corresponding analysis result, wherein the severity of gastric reflux in the analysis result can be set to the highest level. In other words, at this time, the severity of gastric reflux does not need to be determined by 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.

[0060] Preferably, the endotracheal tube 400 for mechanical ventilation can adopt a dual-lumen catheter design, wherein the dual-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. The suction channel can be located beside or inside the gas channel in the endotracheal tube 400 and isolated from the endotracheal tube 400. This allows the suction channel to extract refluxed or aspirated gastric fluid without interfering with gas delivery when directly connected to a negative pressure suction device. The suction channel can adopt a spiral shape or other optimized shape to reduce airway space occupation and prevent blockage. Preferably, the suction channel can be provided with a suction port in a portion of the endotracheal tube 400, wherein the location of the suction port is associated with the location of the pH sensor, that is, the location of the suction port is located near the location of the pH sensor, so that when the corresponding pH sensor detects reflux or aspiration in the patient, targeted suction can be completed in the corresponding area. 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 especially refer to a position located above the expansion balloon 410.

[0061] By placing the suction port in strategic areas near the pH sensor, such as the mouth, epiglottis, or trachea (particularly the area above the dilation balloon 410), the device can immediately initiate suction upon detection of gastric reflux or aspiration, directly targeting the affected area. This approach not only improves suction accuracy and efficiency, but also rapidly removes locally accumulated gastric fluid, effectively reducing the risk of serious complications caused by aspiration. Compared with traditional methods, this targeted suction mechanism significantly reduces the possibility of further spread of aspirated material, thereby better protecting the patient's airway from damage. Furthermore, the dual-lumen catheter design ensures complete separation of gas delivery and fluid extraction, unimpeding respiratory support and maintaining a stable gas exchange environment. This feature is particularly important for critically ill patients, as it ensures continuous delivery of essential oxygen even in emergency situations, avoiding respiratory interruption or instability caused by suctioning. From a clinical perspective, this improvement significantly simplifies the operational process for medical staff, reduces the additional burden of managing reflux or aspiration events, and provides more intuitive feedback, helping them make timely and correct decisions. For patients, this design can respond to gastric reflux or aspiration in the shortest possible time, minimize potential harm, and significantly improve the quality of prognosis.

[0062] 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.

[0063] 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 these data information can be displayed to medical staff in a visual manner through the display unit, so that medical staff can intuitively understand the patient's gastric reflux situation. Preferably, the terminal device 300 can be provided with an operating unit for adjusting the parameters of the terminal device 300 itself and / or the sensors connected to the terminal device 300, so as to meet the usage habits of different users. Preferably, the terminal device 300 can be provided with an alarm unit, so that when the analysis unit 310 determines that the patient has gastric reflux based on the analysis results it generates, it can send different alarm signals according to the severity of the current gastric reflux, thereby reminding medical staff to deal with it in time.

[0064] 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 on 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 having to be set. 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 patient's oral cavity or epiglottis area; a second pH value sensor (200) for measuring the pH value of the area where the expansion balloon (410) on the tracheal tube (400) is located, the expansion balloon (410) on the tracheal tube (400) can be arranged in the patient's trachea and in contact with the tracheal wall, the second pH value sensor (200) can be arranged in a position relatively closer to the esophagus in the current area in the corresponding layout area, and can be arranged on the outer wall of the tracheal 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 tracheal tube (400), it can be arranged on a side of the outer wall of the tracheal 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 on a local position on the upper end surface of the expansion balloon (410) close to the patient's back; 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: Determine the change of the pH value of the patient's oral cavity or epiglottis area over time based on the pH value provided by the first pH sensor (100), Determine the change of the pH value of the upper end of the expansion balloon (410) over time based on the pH value provided by the second pH value sensor (200), After receiving the pH value of the corresponding area of ​​the patient collected by the first pH sensor (100), it can be compared with the theoretical data built into the analysis unit (310) to determine the degree of deviation of the real-time collected data and generate corresponding analysis results, and / or directly generate 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, Among them, the theoretical data includes first theoretical data and second theoretical data. The first theoretical data is the ideal data of the pH value of the corresponding area of ​​the patient changing 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. The analysis results include whether the patient has gastric reflux and the severity of the gastric reflux.

2. The gastric reflux prediction device according to claim 1, characterized in that The first pH sensor (100) and the second pH sensor (200) can perform data transmission via a wired and / or wireless manner, wherein, when transmitting via a wired manner, the data transmission line (110) of the first pH sensor (100) and / or the second pH sensor (200) can be drawn 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) can be set in a position relatively closer to the esophagus in the current area in the corresponding layout area, wherein the first pH sensor (100) can select different setting positions according to the type of tracheal tube (400) used by the mechanically ventilated patient, and the type of tracheal 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 a patient 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) in the area of ​​the patient's epiglottis, and on the side of the outer wall of the endotracheal tube (400) in this area facing the patient's back.

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

7. 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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