A gastroesophageal and laryngeal multi-channel pH synchronous monitoring system and method

Abstract

The application provides a gastroesophageal and throat multi-channel pH synchronous monitoring system and method. The system comprises: a flexible catheter for transnasal insertion to a monitoring site; a plurality of pH sensors integrated on the flexible catheter for monitoring the pH values of the throat, the upper esophagus and the lower esophagus respectively; a signal collector connected to the proximal end of the flexible catheter for synchronously collecting the data of the plurality of pH sensors; and an analysis module for judging the reflux path and making a diagnosis according to the time sequence and amplitude of the data changes of the plurality of pH sensors. The application integrates multiple pH sensors on a single flexible catheter to simultaneously monitor the pH of multiple sites, and uses a signal collector to synchronously collect pH data, thereby realizing gastroesophageal-throat multi-channel pH synchronous monitoring, judging the reflux path and making a reflux diagnosis based on the synchronous monitoring data, and improving the accuracy of reflux diagnosis.

Description

Technical Field

[0001] This application relates to the field of medical testing equipment technology, and in particular to a multi-channel pH synchronous monitoring system and method for the gastroesophageal and pharyngeal regions. Background Technology

[0002] Gastroesophageal airway reflux disease (GARD) is a condition caused by the reflux of gastrointestinal contents into the esophagus and airway, leading to irritation and damage. GARD is characterized by two common types: gastroesophageal reflux disease (GERD) and laryngopharyngeal reflux (LPR). GERD is a series of clinical syndromes caused by the reflux of gastric and duodenal contents into the esophagus and other parts of the body. Laryngopharyngeal reflux is considered an extraesophageal variant of GERD.

[0003] Dynamic pH monitoring is a crucial method for assessing gastric acid reflux into the esophagus and pharynx. Currently, in clinical settings requiring simultaneous monitoring of pH levels in both the pharynx and esophagus, separate measurements are primarily used: the first measurement places the sensor in the esophagus, and the second measurement places the sensor near the pharynx. This method, with data from different time periods, fails to identify the impact of external disturbances (such as drinking, swallowing, or coughing) on ​​the two measurements, resulting in low data accuracy. Furthermore, it cannot synchronously correlate the pH states in the pharynx and esophagus at the same time point or for the same reflux event, making it difficult to accurately analyze the pathway of the reflux event and its impact on the pharynx. Summary of the Invention

[0004] To address the shortcomings of existing technologies, the purpose of this application is to provide a multi-channel pH synchronous monitoring system and method for the gastroesophageal and pharyngeal regions, which simplifies operation and improves the accuracy of reflux analysis while achieving synchronous pH monitoring of the gastroesophageal and pharyngeal regions.

[0005] To achieve the above objectives, this application provides a multi-channel simultaneous pH monitoring system for the gastroesophageal and pharyngeal regions, comprising:

[0006] The plurality of pH sensors include:

[0007] A pharyngeal probe, fixed in the middle of the flexible catheter body, is used to monitor the pH value of the pharynx;

[0008] A gastroesophageal probe, fixed to the end of the flexible catheter body, is used to monitor the pH value at a target monitoring location in the esophagus.

[0009] Furthermore, the plurality of pH sensors include:

[0010] A pharyngeal probe, fixed in the middle of the flexible catheter body, is used to monitor the pH value of the pharynx;

[0011] The first gastroesophageal probe is fixed to the end of the flexible catheter body and is used to monitor the pH value at the first target monitoring location in the esophagus.

[0012] The second gastroesophageal probe is fixed in the lower part of the flexible catheter body and is used to monitor the pH value at the second target monitoring location in the esophagus.

[0013] Furthermore, the analysis module is configured as follows:

[0014] The original pH signal was denoised.

[0015] Acid reflux suspected events were labeled based on the denoised pH signal;

[0016] Calculate the time difference of suspected acid reflux events between adjacent pH sensors;

[0017] The backflow path is determined based on the time difference and the order of events.

[0018] Data that matches the reflux path is used for reflux diagnosis.

[0019] Furthermore, the criteria for marking the suspected acid reflux event are as follows:

[0020] pH value is below the threshold; or

[0021] pH value continuously below the threshold for more than 5 seconds; or

[0022] The pH value dropped rapidly within 2 seconds, with a decrease greater than 10% of the average value of the previous 15 minutes.

[0023] Furthermore, the reflux path determination condition is as follows:

[0024] 1) Only the furthest pH sensor detected a suspected acid reflux event; or

[0025] 2) Both adjacent pH sensors detected suspected acid reflux events; and

[0026] The suspected acid reflux event at the distal end occurred before the suspected acid reflux event at the proximal end; and

[0027] The conduction time difference does not exceed the preset conduction time;

[0028] The proximal end is the end closest to the outside of the body, and the distal end is the end furthest from the outside of the body.

[0029] Furthermore, each of the plurality of pH sensors is a miniature pH electrode or a wireless pH capsule.

[0030] Furthermore, the signal acquisition unit has a built-in real-time clock for generating timestamps with a unified time base for the sampling data from all pH sensors.

[0031] Furthermore, the flexible catheter is embedded with signal transmission wires corresponding to each pH sensor. The signal transmission wires extend from each pH sensor to the proximal end of the flexible catheter and are connected to the signal acquisition device through a single connection interface.

[0032] To achieve the above objectives, this application also provides a method for simultaneous multi-channel pH monitoring of the gastroesophageal and pharyngeal regions, employing the multi-channel pH monitoring system for the gastroesophageal and pharyngeal regions as described above. The method includes the following steps:

[0033] Multiple pH sensors were used to monitor pH values ​​at target monitoring locations in the pharynx and esophagus;

[0034] Data from the multiple pH sensors are collected synchronously using a signal acquisition device;

[0035] Based on the data from the multiple pH sensors, the reflux path is determined and the reflux index is calculated;

[0036] Reverse flow diagnosis is performed based on the reverse flow path and the reverse flow index.

[0037] The multi-channel pH synchronous monitoring system for the gastroesophageal and pharyngeal regions provided in this application integrates multiple pH sensors on a single flexible catheter to simultaneously monitor the pH at multiple sites and uses a signal acquisition device to synchronously collect pH data, thereby realizing synchronous pH monitoring of the gastroesophageal-pharyngeal multi-channel system. Based on the synchronous monitoring data, the system can determine the reflux pathway and reflux diagnosis, which improves the convenience of data acquisition and the accuracy of reflux diagnosis and analysis.

[0038] Other features and advantages of this application will be set forth in the following description, and will be apparent in part from the description, or may be learned by practicing this application. Attached Figure Description

[0039] The accompanying drawings are provided to further illustrate the present application and form part of the specification. Together with the embodiments of the present application, they serve to explain the present application but do not constitute a limitation thereof. In the drawings:

[0040] Figure 1 This is a schematic diagram of the multi-channel pH synchronous monitoring system for the gastroesophageal and pharyngeal regions according to Embodiment 1 of this application;

[0041] Figure 2 This is a schematic diagram of the flexible catheter and signal acquisition device according to Embodiment 1 of this application;

[0042] Figure 3This is a schematic diagram of pH monitoring data at different locations during reflux according to Example 1 of this application;

[0043] Figure 4 This is a schematic diagram of pH monitoring data at different locations during another backflow according to Example 1 of this application;

[0044] Figure 5 This is a schematic diagram of pH monitoring data at different locations during another backflow according to Example 1 of this application;

[0045] Figure 6 This is a schematic diagram of pH monitoring data at different locations when no backflow occurs, according to Example 1 of this application;

[0046] Figure 7 This is a schematic diagram of the multi-channel pH synchronous monitoring system for the gastroesophageal and pharyngeal regions according to Embodiment 2 of this application;

[0047] Figure 8 This is a schematic diagram of the flexible catheter and signal acquisition device according to Embodiment 2 of this application;

[0048] Figure 9 This is a flowchart of a multi-channel simultaneous pH monitoring method for the gastroesophageal and pharyngeal regions according to Embodiment 3 of this application. Detailed Implementation

[0049] The preferred embodiments of this application are described below with reference to the accompanying drawings. It should be understood that the preferred embodiments described herein are for illustration and explanation only and are not intended to limit this application.

[0050] Embodiments of this application will now be described in more detail with reference to the accompanying drawings. While some embodiments of this application are shown in the drawings, it should be understood that this application can be implemented in various forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided to provide a more thorough and complete understanding of this application. It should be understood that the drawings and embodiments of this application are for illustrative purposes only and are not intended to limit the scope of protection of this application.

[0051] The term "comprising" and its variations as used herein are open-ended inclusions, meaning "including but not limited to". The term "based on" means "at least partially based on". The term "one embodiment" means "at least one embodiment"; the term "another embodiment" means "at least one additional embodiment"; the term "some embodiments" means "at least some embodiments". Definitions of other terms will be given in the description below.

[0052] It should be noted that the terms "first" and "second" may be used in this application only to distinguish different devices, components or parts, and are not used to define the order of functions performed by these devices, components or parts or their interdependence.

[0053] It should be noted that the terms "one" and "more" used in this application are illustrative rather than restrictive, and those skilled in the art should understand that, unless explicitly stated otherwise in the context, they should be understood as "one or more". "More" should be understood as two or more.

[0054] Example 1

[0055] In an embodiment of this application, a multi-channel pH synchronous monitoring system for the gastroesophageal and pharyngeal regions is provided. The system includes: a flexible catheter for insertion via the nasal cavity to the monitoring site; multiple pH sensors integrated onto the flexible catheter for monitoring pH values ​​in the pharynx, upper esophagus, and lower esophagus, respectively; a signal acquisition unit connected to the proximal end of the flexible catheter for synchronously acquiring data from the multiple pH sensors; and an analysis module for determining the reflux path and performing diagnosis based on the temporal sequence and amplitude of changes in the data from the multiple pH sensors.

[0056] Figure 1 The following is a schematic diagram of the multi-channel pH synchronous monitoring system for the gastroesophageal and pharyngeal regions according to Embodiment 1 of this application. (Refer to the following...) Figure 1 The multi-channel pH synchronous monitoring system for the gastroesophageal and pharyngeal regions described in Example 1 of this application is described in detail.

[0057] The multi-channel synchronous pH monitoring system for the gastroesophageal and pharyngeal regions, as described in this application, includes three pH sensors 101, a flexible catheter 102, a signal acquisition unit 103, and an analysis module 104. The three pH sensors 101 are integrated at different locations on the flexible catheter 102 and are inserted through the nasal cavity into the monitoring site, such as the pharynx or esophagus, to monitor pH values ​​at different sites. The signal acquisition unit 103 is connected to the flexible catheter 102 and is used to synchronously acquire pH data from each pH sensor 101. The analysis module 104 is used to determine the reflux path and perform diagnosis based on the temporal sequence and magnitude of pH value changes detected by each pH sensor 101.

[0058] Figure 2 The diagram below shows the flexible catheter and signal acquisition device according to Embodiment 1 of this application, with reference to... Figure 2In the embodiments of this application, the three pH sensors 101 are a pharyngeal probe T3, a second gastroesophageal probe T2, and a first gastroesophageal probe T1. The pharyngeal probe T3 is fixed to the middle of the flexible catheter D1, and its position is designed so that when the flexible catheter D1 is in place, the pharyngeal probe T3 is precisely located at the target pharyngeal monitoring position (near the hypopharynx and pyriform fossa). The second gastroesophageal probe T2 is fixed to the lower part of the flexible catheter D1, and its position is designed so that when the pharyngeal probe T3 is in place, the second gastroesophageal probe T2 is located approximately 5 cm below the upper esophageal sphincter. The first gastroesophageal probe T1 is fixed to the end of the flexible catheter D1, and its position is designed so that when the pharyngeal probe T3 is in place, the first gastroesophageal probe T1 is located at the target monitoring position in the esophagus (typically 5-10 cm above the lower esophageal sphincter). The probe characteristics of the first gastroesophageal probe T1 and the second gastroesophageal probe T2 are consistent with those of the pharyngeal probe T3. Each probe's interface is located at the proximal end (external end) of the flexible catheter D1, and is connected to the signal acquisition device C1 via a common signal connector C2.

[0059] In the embodiments of this application, the signal acquisition unit C1 has a built-in unique high-precision real-time clock that generates timestamps with a unified time base for pH sampling data from all probes. This enables strict synchronization and continuous monitoring of pH values ​​in the pharynx (T3), the middle esophagus (T2), and the lower esophagus (T1), ensuring that all data points are on the same timeline. Simultaneously, the patient only needs to insert a catheter into one nasal cavity, reducing patient discomfort and increasing ease of operation.

[0060] During testing, the signal connector C2 at the proximal end of the flexible catheter D1 is inserted into the signal acquisition device C1. C1 is then powered on, and probes T3 / T2 / T1 are inserted into the target monitoring position through the nasal cavity. The flexible catheter D1, integrating multiple probes, is inserted into one nasal cavity in a single procedure, allowing for multi-channel pH monitoring of the gastroesophageal and pharyngeal regions with only one insertion. Furthermore, the insertion position of the pharyngeal probe T3 can be directly observed through the oral cavity. Since the distance between the three probes is well-defined, the insertion positions of T2 and T1 can be accurately determined, enabling simultaneous determination of the positions of the first gastroesophageal probe (T1) and the second gastroesophageal probe (T2). This avoids secondary insertion or X-ray localization, reduces nasal insertion trauma, and improves patient compliance and monitoring success rate. The signal acquisition device C1 synchronously collects and stores pH information from the three probes at fixed intervals, achieving simultaneous dual-channel monitoring with a single acquisition device. After testing, the probes are simply removed, making operation convenient. Finally, the analysis module 104 analyzes the information collected by the signal acquisition device C1 using a built-in recognition algorithm to identify patterns in pH changes and reflux indicators.

[0061] In some embodiments of this application, each probe is a miniature pH electrode. A signal transmission wire for each pH electrode extends from the respective probe, is embedded in the inner wall of the flexible catheter D1, and extends to a common signal connector C2 at the proximal end of the flexible catheter D1. The signal connector C2 connects the probe to the signal collector C1. In other embodiments of this application, each probe is a wireless pH capsule, transmitting data wirelessly to the signal collector C1.

[0062] In the embodiments of this application, the analysis module 104 is used to analyze the temporal sequence and amplitude relationship of pH data changes at three different sites to determine whether refluxed material has been transmitted from the stomach through the esophagus to the pharynx, thereby performing reflux diagnosis. Specifically, the analysis module 104 is configured to perform the following steps:

[0063] 1) Denoise the raw pH signal, such as by smoothing it to remove noise interference.

[0064] 2) Mark suspected acid reflux events. When the pH value at any location falls below the threshold (e.g., 4.0), or remains below the threshold for more than 5 seconds, or when the pH value drops rapidly within 2 seconds with a decrease greater than 10% of the average value over the previous 15 minutes, mark it as a "suspected acid reflux event." Record the start and end times of the event. Because the stomach, esophagus, and pharynx have different pH tolerances, the threshold values ​​for probes at different locations can be set to different values. The principle should be that the pH threshold should be set lower for probes closer to the stomach.

[0065] 3) Calculate the time difference of suspected acid reflux events between adjacent pH sensors. Compare the suspected acid reflux events of two adjacent probes and calculate their time difference.

[0066] 4) Determine the reverse flow path based on the time difference and event sequence.

[0067] In the embodiments of this application, the determination of the pharyngeal reflux path requires that the following conditions be met simultaneously:

[0068] When the pH threshold is set to P0, a suspected acid reflux event is detected at T3; when the pH threshold is set to P0, a suspected acid reflux event is detected at T2; the event detected at T3 occurs later than that detected at T2.

[0069] The difference between the time of event occurrence detected by T3 and the time of event occurrence detected by T2 is less than the specified propagation time, such as 2 minutes;

[0070] P0 can be set to pH=5.5, pH=6.0, or pH=6.5, etc.

[0071] To determine the pathway of gastroesophageal reflux (such as eating, swallowing saliva, etc.), the following conditions must be met simultaneously:

[0072] The pH threshold was set to S0, and a suspected acid reflux event was detected at T1.

[0073] The pH threshold was set to S1, and a suspected acid reflux event was detected at T2.

[0074] The event detected by T2 occurred later than that detected by T1;

[0075] The difference between the time of event occurrence detected by T2 and the time of event occurrence detected by T1 is less than the specified propagation time, such as 2 minutes;

[0076] S0 is generally set to pH=4, while S1 can be set to pH=4, pH=5, or pH=5.5, etc.

[0077] 5) Filter data that matches the reflux path for reflux diagnosis.

[0078] In the embodiments of this application, step 5) includes diagnosis of laryngeal reflux, diagnosis of gastroesophageal reflux, and comprehensive diagnosis. The steps for diagnosing laryngeal reflux include: for events that do not meet the criteria for laryngeal reflux pathway determination, deleting the event and its corresponding raw pH data as abnormal data, and then using the Ryan index or W index to diagnose laryngeal reflux. The steps for diagnosing gastroesophageal reflux include: for events that do not meet the criteria for gastroesophageal reflux pathway determination, deleting the event and its corresponding raw pH data as abnormal data, and then using the Demeester index to diagnose gastroesophageal reflux. Comprehensive diagnosis: The patient may only have laryngeal reflux, or only gastroesophageal reflux, or both laryngeal reflux and gastroesophageal reflux, or no reflux at all.

[0079] Figure 3 This is a schematic diagram of pH monitoring data at different locations during reflux, based on Example 1 of this application. Figure 3 As shown, the reflux occurs sequentially along the pathways from "stomach T1" to "esophagus T2" to "pharynx T3". This pattern aligns with the typical progression of reflux disease, indicating a simultaneous occurrence of gastroesophageal reflux and laryngeal reflux.

[0080] Figure 4 This is a schematic diagram of pH monitoring data at different locations during reflux, according to Example 1 of this application. Figure 4 As shown, reflux occurs sequentially along the path from "pharynx T3" to "esophagus T2" to "stomach T1". Since this can also occur when swallowing acidic foods or drinks, this pattern cannot be used to diagnose reflux disease.

[0081] Figure 5 This is a schematic diagram of pH monitoring data at different locations during reflux, according to Example 1 of this application. Figure 5As shown, the reflux occurs along the direction of "stomach T1" to "esophagus T2". Since the reflux starts in the stomach and there is no reflux in the throat, it can be determined to be gastroesophageal reflux.

[0082] Similarly, it can be deduced that only pharyngeal reflux exists: reflux occurs along the "esophagus T2" - "pharynx T3" direction, with reflux in the pharynx but not in the stomach.

[0083] Figure 6 This is a schematic diagram of pH monitoring data at different locations when no backflow occurs, according to Example 1 of this application. Figure 6 As shown, the pH monitoring data for "stomach T1", "esophagus T2", and "pharynx T3" all showed no reflux, and the diagnosis result was no reflux.

[0084] The multi-channel pH synchronous monitoring system for the gastroesophageal and pharyngeal regions provided in this application, through an innovative three-in-one design of "single catheter multi-probe integration," "unique clock synchronous acquisition," and "analysis and recognition algorithm," achieves synchronous pH monitoring of the pharynx and gastroesophageal tract. It intelligently distinguishes between reflux and swallowing events, enabling accurate diagnosis of the presence of pharyngeal reflux and gastroesophageal reflux. Its effects are directly reflected in: obtaining high-value synchronous data, achieving accurate event-based diagnosis, and significantly simplifying clinical procedures. It provides a more powerful, efficient, and user-friendly tool for the diagnosis of gastroesophageal reflux disease (GERD) and laryngeal reflux (LPR), demonstrating significant clinical value and application prospects.

[0085] Example 2

[0086] The difference between this embodiment and Embodiment 1 is that the number of pH sensors is 2.

[0087] Figure 7 The following is a schematic diagram of the multi-channel pH synchronous monitoring system for the gastroesophageal and pharyngeal regions according to Embodiment 2 of this application. (Refer to the following...) Figure 7 The multi-channel pH synchronous monitoring system for the gastroesophageal and pharyngeal regions described in Example 2 of this application is described in detail.

[0088] The multi-channel synchronous pH monitoring system for the gastroesophageal and pharyngeal regions, as described in this application, includes two pH sensors 201, a flexible catheter 202, a signal acquisition unit 203, and an analysis module 204. The signal acquisition unit 203 is connected to the flexible catheter 202 and is used to synchronously acquire pH data from each pH sensor 201. The analysis module 204 is used to determine the reflux path and perform reflux diagnosis based on the temporal sequence and magnitude of pH value changes detected by the two pH sensors 201.

[0089] Figure 8 This is a schematic diagram of the flexible catheter and signal acquisition device according to Embodiment 2 of this application, as shown below. Figure 8As shown, the two pH sensors 201 are a pharyngeal probe T2 integrated into the proximal end of the flexible catheter D1 and a gastroesophageal probe T1 integrated into the distal end. The pharyngeal probe T2 is used to monitor the pH value at the target monitoring location in the pharynx (such as the hypopharynx or near the pyriform fossa), and the gastroesophageal probe T1 is used to monitor the pH value at the target monitoring location in the esophagus (5-10 cm below the lower esophageal sphincter in this embodiment).

[0090] In the embodiments of this application, the analysis module 204 determines whether refluxed material is transmitted from the stomach through the esophagus to the pharynx, or whether it is an independent pharyngeal reflux event, by analyzing the sequence, time interval, and amplitude changes of pH signals from the gastroesophageal probe T1 and the pharyngeal probe T2. Specifically, the analysis module 204 is configured to perform the following steps to determine the reflux path:

[0091] Step 1: Smooth the raw pH signal to remove momentary interference from swallowing, breathing, etc.

[0092] Step 2: When the pH value at any location is below 4.0, or the pH value is continuously below the threshold for more than 5 seconds, or the pH value drops rapidly within 2 seconds and the drop is greater than 10% of the average value of the previous 15 minutes, mark it as a "suspected acid reflux event" and record the start and end times of the event.

[0093] Step 3: Compare the acid reflux events of each pair of distal and proximal ends, and calculate the time difference between the start time of the proximal event and the start time of the distal event.

[0094] Step 4: Determine the reflux pathway (stomach → esophagus → pharynx). The determination criteria include:

[0095] 1) Only the furthest pH sensor detected a suspected acid reflux event; or

[0096] 2) Acid reflux events occurred at both monitoring sites, meaning the pH values ​​at both the distal and proximal sites met the criteria for an acid reflux event; and

[0097] The time sequence is reasonable; suspected distal acid reflux events must occur before suspected proximal acid reflux events (the time difference must be positive); and

[0098] The conduction time is within a reasonable range, that is, the time difference does not exceed the preset maximum conduction time (e.g., 5 minutes).

[0099] Step 5: Determining Non-Reflux Pathways (Independent Pharyngeal Events or Non-Gastrointestinal Reflux). A non-reflux pathway is determined when any of the following conditions are met:

[0100] Time sequence error or window overflow;

[0101] Near events occur before far events (the time difference is negative);

[0102] Or the time difference exceeds 5 minutes.

[0103] Event independence verification: Acid reflux events occurred in only one location or in all locations.

[0104] Step 6: If a reflux pathway is observed, record it. The reflux pathway is one of the main bases for diagnosing laryngeal reflux and gastroesophageal reflux.

[0105] In some embodiments of this application, the signal acquisition device C1 is a single acquisition device with a built-in high-precision real-time clock. In other embodiments of this application, the signal acquisition device C1 can be two acquisition devices with forced clock synchronization, with one of the acquisition devices storing data to achieve synchronous acquisition of data from two pH sensors.

[0106] The multi-channel pH synchronous monitoring system for the gastroesophageal and pharyngeal regions provided in this application employs two pH sensors—a pharyngeal probe (T2) and a gastroesophageal probe (T1)—to precisely and continuously monitor pH values ​​in the pharynx and esophagus, ensuring all data points are on the same timeline and providing high-value data for reflux diagnosis. Patients only need to insert a flexible catheter D1 through one nasal cavity, reducing patient discomfort and increasing ease of operation. Simultaneously, it lowers the investment cost of the testing equipment.

[0107] Example 3

[0108] In this embodiment of the application, a method for simultaneous multi-channel pH monitoring of the gastroesophageal and pharyngeal tracts is also provided, which uses the above-mentioned simultaneous multi-channel pH monitoring system for the gastroesophageal and pharyngeal tracts.

[0109] Figure 9 The flowchart of the multi-channel simultaneous pH monitoring method for the gastroesophageal tract and pharynx according to Embodiment 3 of this application will be referenced below. Figure 9 This application describes in detail the method for simultaneous multi-channel pH monitoring of the gastroesophageal tract and pharynx according to embodiments of the present application.

[0110] First, in step 301, the pH value of the target monitoring locations in the throat and esophagus is monitored using multiple pH sensors.

[0111] In step 302, data from the multiple pH sensors are collected synchronously using a signal acquisition device.

[0112] In step 303, the reflux path is determined and the reflux index is calculated based on the data from the multiple pH sensors.

[0113] In the embodiments of this application, the reflux index includes: the order and time difference of acid reflux events at each monitoring site. In step 304, reflux diagnosis is performed based on the reflux path and the reflux index.

[0114] It will be understood by those skilled in the art that the above descriptions are merely preferred embodiments of this application and are not intended to limit this application. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A multi-channel simultaneous pH monitoring system for the gastroesophageal and pharyngeal regions, characterized in that, include: A flexible catheter is used for insertion through the nasal cavity to the monitoring site; Multiple pH sensors are integrated on the flexible catheter to monitor the pH value in the pharynx and esophagus, respectively. A signal acquisition device, connected to the proximal end of the flexible catheter, is used to synchronously acquire data from the multiple pH sensors; The analysis module is configured as follows: The original pH signal was denoised. Acid reflux suspected events are marked based on the denoised pH signal; the time difference between acid reflux suspected events of adjacent pH sensors is calculated; the reflux path is determined based on the time difference and the order of event occurrence; data that matches the reflux path are selected for reflux diagnosis. The reflux path determination condition is: only the furthest pH sensor detects a suspected acid reflux event; or Both adjacent pH sensors detected suspected acid reflux events, with the suspected acid reflux event at the far end occurring before the suspected acid reflux event at the near end, and the conduction time difference not exceeding the preset conduction time. The proximal end is the end closest to the outside of the body, and the distal end is the end furthest from the outside of the body.

2. The multi-channel pH synchronous monitoring system for the gastroesophageal and pharyngeal tract according to claim 1, characterized in that, The plurality of pH sensors include: a pharyngeal probe, fixed in the middle of the flexible catheter body, for monitoring the pH value of the pharynx; and a gastroesophageal probe, fixed at the end of the flexible catheter body, for monitoring the pH value at a target monitoring location in the esophagus.

3. The multi-channel pH synchronous monitoring system for the gastroesophageal and pharyngeal regions according to claim 1, characterized in that, The plurality of pH sensors include: a pharyngeal probe, fixed to the middle of the flexible catheter body, for monitoring the pH value of the pharynx; a first gastroesophageal probe, fixed to the end of the flexible catheter body, for monitoring the pH value of a first target monitoring location in the esophagus; and a second gastroesophageal probe, fixed to the lower middle part of the flexible catheter body, for monitoring the pH value of a second target monitoring location in the esophagus.

4. The multi-channel pH synchronous monitoring system for the gastroesophageal and pharyngeal regions according to claim 1, characterized in that, The criteria for identifying suspected acid reflux events are: pH value below the threshold; or pH value continuously below the threshold for more than 5 seconds; or pH value rapidly decreasing within 2 seconds, with a decrease greater than 10% of the average value of the previous 15 minutes.

5. The multi-channel pH synchronous monitoring system for the gastroesophageal and pharyngeal regions according to claim 1, characterized in that, Each of the plurality of pH sensors is a miniature pH electrode or a wireless pH capsule.

6. The multi-channel pH synchronous monitoring system for the gastroesophageal tract and pharynx according to claim 1, characterized in that, The signal acquisition unit has a built-in real-time clock, which is used to generate timestamps with a unified time base for the sampling data of all pH sensors.

7. The multi-channel pH synchronous monitoring system for the gastroesophageal and pharyngeal regions according to claim 1, characterized in that, The flexible catheter is embedded with signal transmission wires corresponding to each pH sensor. The signal transmission wires extend from each pH sensor to the proximal end of the flexible catheter and are connected to the signal acquisition device through a single connection interface.

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