A system for monitoring gastrointestinal disorders

The system integrates gastrointestinal probe measurements with patient parameters to objectively evaluate symptom intensity and correlate with gastro-esophageal content events, addressing the inefficiencies of patient-reported symptoms and improving diagnostic accuracy in gastrointestinal disorder assessments.

JP7911005B2Active Publication Date: 2026-08-25フォンダシオン·ドゥ·コオペラシオン·シアンティフィック
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Patent Information

Application Number
JP2023557400
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2021-03-20
Filing Date
2022-03-18
Publication Date
2026-08-25
Estimated Expiration
2042-03-18

AI Technical Summary

Technical Problem

Existing gastrointestinal disorder diagnosis systems rely heavily on patient-reported symptoms (PRS), which are subjective and prone to inaccuracies due to patient forgetfulness or inductive reporting, leading to inefficiencies and misinterpretation of gastro-esophageal content measurements (GECM) events.

Method used

A system that combines gastrointestinal probe measurements of stomach and esophageal contents with patient parameters like pain and stress, using sensors to objectively determine symptom intensity and correlate with GECM events, incorporating patient activity and posture information to enhance diagnostic accuracy.

Benefits of technology

Improves diagnostic accuracy by objectively assessing patient-reported symptoms and gastro-esophageal content measurements, reducing subjectivity and enhancing the reliability of gastrointestinal disorder assessments.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention relates to a system for monitoring gastrointestinal disorders, the system including a gastrointestinal probe, at least one sensor configured to measure a patient parameter, a patient interface configured to receive input from the patient, and a processor configured to: determine a first value and a second value corresponding to a given time interval, where if the input from the patient corresponds to the given time interval, the first value is determined based on a measurement of the parameter corresponding to the given time interval and based on the input from the patient corresponding to the given time interval, and the second value is determined based on a measurement of gastroesophageal contents corresponding to the given time interval; and determine a level of gastrointestinal disorders based on the set of determined value pairs.
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Description

Technical Field

[0001] The present invention generally relates to the field of medical devices, and more specifically to a system for monitoring gastrointestinal disorders.

Background Art

[0002] Gastrointestinal disorders have various forms and levels of impact on health and on the quality of life.

[0003] Most diagnoses are made based on patient-reported symptoms (PRS) and perceptions.

[0004] Also, the diagnosis may be based on a system that depends on an internal probe that abuts or is temporarily implanted against the patient's gastrointestinal wall to measure or capture information about gastro-esophageal contents. The gastro-esophageal content measurements (GECM) are transmitted and stored in a patient-worn device.

[0005] More recently, systems have been developed that place the basis of the diagnosis on both GECM and PRS, where the PRS is entered by the patient into their worn device. Such systems match GECM events with PRS events and use known models to provide a disease severity scoring indication, such as a symptom correlation score.

[0006] However, these techniques lack efficiency. In fact, the diagnosis is highly dependent on the patient input of PRS, which is related to the patient's perception and thus highly subjective. Further, patients often forget to enter the PRS or simply postpone its entry, which causes inaccuracies in the diagnosis. Further, when the patient's activities are taken into account, it is inductive.

Summary of the Invention

[0007] The present invention aims to improve this situation. [Means for solving the problem]

[0008] For that purpose, the present invention is a system for monitoring gastrointestinal disorders, A gastrointestinal probe configured to measure the contents of a patient's stomach and esophagus, At least one sensor configured to measure a patient's parameters, wherein the parameters depend on the patient's pain and / or stress, A patient interface configured to receive input from a patient, wherein the input corresponds to a patient-reported symptom (PRS), and It is a processor, This involves determining a set of pairs of values ​​corresponding to each set of different time intervals, where each pair of values ​​corresponding to a given time interval in the set of different time intervals includes a first value and a second value. If the input from the patient corresponds to a given time interval, the first value described above is determined based on the measured value of the parameter corresponding to the given time interval and based on the input from the patient corresponding to the given time interval. The second value above is determined based on the measured values ​​of gastroesophageal contents corresponding to a given time interval, and Determining the level of gastrointestinal disorder based on a set of determined values. A processor and Including, related to the system.

[0009] This system can improve the accuracy of diagnosis. In reality, PRS experienced by patients is physical and therefore highly subjective. Thus, some patients report severe pain, while others feel no pain at all with respect to the same phenomenon. By determining a first value that takes into account parameters influenced by the patient's pain and / or stress during the time period in which gastroesophageal contents measurements are performed, it becomes possible to have an objective value for the intensity of PRS and to avoid misinterpreting GECM events in which the patient actually experiences some PRS but does not report it.

[0010] Based on this objective first value, the level of gastrointestinal disorder is therefore more relevant. This score can be obtained by showing the correlation between events indicated by the first value and events indicated by the second value, which is based on measurements of gastroesophageal contents. Such correlations can be performed using existing techniques that combine PRS and GECM values, for example, by substituting these values ​​with the first and second values ​​respectively. These techniques include, for example, symptom correlation scores.

[0011] Gastrointestinal probes allow for the identification of in vivo probes that can measure parameters of gastroesophageal contents, particularly the pH of gastroesophageal contents, over time.

[0012] The patient's pain and / or stress-dependent parameters reveal any changes in the patient's parameters when they experience pain or stress, such as increases in heart rate, body temperature, sweating, and stress-related hormone levels.

[0013] The input received from the patient reveals any inputs, particularly those related to the type and / or intensity of PRS experienced by the patient.

[0014] A set of different time intervals allows us to determine all time divisions within the time period over which gastroesophageal contents are measured. Time divisions, such as those in which each time interval has the same duration, can be predetermined. Alternatively, time divisions can be determined during medical monitoring. For example, each gastroesophageal contents measurement event, i.e., each time at which a significant evolution of the parameter is measured, may begin with a time interval in which its duration is the same or different with respect to the entire time interval, for example, based on the intensity of the gastroesophageal contents measurement event or until the next gastroesophageal contents measurement event.

[0015] The parameters corresponding to a given time interval indicate that the parameter measurements were performed within that time interval.

[0016] The patient's input corresponding to a given time interval indicates that the input was performed within that time interval.

[0017] By measuring the contents of the stomach and esophagus corresponding to a given time interval, it can be determined that the measurement of the contents of the stomach and esophagus was performed within the given time interval.

[0018] The first value is determined based on the measurement of the parameter, or more specifically, based on data that shows the measurement of the parameter.

[0019] The level of gastrointestinal disorder can be determined as a score associated with the level of gastrointestinal disorder, and this score is determined based on a set of pairs of determined values.

[0020] According to an aspect of the present invention, the first value determined based on the measured values ​​of the parameters and input from the patient is - Weighting of parameter measurements based on input from patients, or - Weighting values ​​corresponding to patient input based on parameter measurements. It is determined by [the following].

[0021] By adding weights to the values corresponding to the patient's input based on the measured values of the parameters, it can be seen that the events experienced by the patient and causing the input are evaluated higher or lower according to the levels of the parameters related to the patient's pain and / or stress. Thus, the PRS inputted while the level of the parameter related to pain and / or stress is low is downgraded and thus will not be considered as much. Conversely, the PRS inputted while the level of the parameter related to pain and / or stress is high is highly evaluated and thus will be considered more.

[0022] By adding weights to the measured values of the parameters (e.g., heartbeats) by the inputted PRS, it can be seen that the pain and / or stress experienced by the patient is evaluated higher or lower by the inputted PRS. Thus, the pain and / or stress experienced by the patient and resulting in a PRS input indicating, for example, a low-intensity PRS is downgraded and thus will not be considered as much. Conversely, the pain and / or stress experienced by the patient and resulting in a PRS input indicating, for example, a high-intensity PRS is highly evaluated and thus will be considered more.

[0023] In either case, the consideration of the parameter makes the first value more objective than if it were based only on the PRS inputted by the patient.

[0024] According to an aspect of the present invention, when the input from the patient does not correspond to a given time interval, the processor is further configured to determine the first value based on the measured value of the parameter corresponding to the given time interval.

[0025] In this case, the input from the patient is not considered for determining the first value, and the first value is based only on the measured value of the parameter. This enables the determination of the first value even when the patient does not input any PRS, for example, when the patient is sleeping or the patient forgets to input the PRS.

[0026] According to an aspect of the present invention, the second value is determined based on a measurement of gastroesophageal contents corresponding to a given time interval and on patient activity information and / or movement and posture information, wherein the patient activity information and the movement and posture information correspond to a given time interval.

[0027] This allows for considering patient activity when determining the second value. In fact, the evolution of GECM may not indicate gastrointestinal dysfunction; for example, sports activity may increase GECM regardless of any gastrointestinal dysfunction. Therefore, the diagnosis is more accurate by not considering GECM related to patient activity, for example. This can be done by determining the second value by weighting the measurements of gastroesophageal contents with patient activity information as well as movement and posture information.

[0028] Patient activity information corresponding to a given time interval indicates that the information refers to patient activities that occur during that time interval. Patient activities include, for example, eating lunch, playing sports, or sleeping.

[0029] Motion and posture information corresponding to a given time interval indicates that the information refers to the patient's movements and postures during that time interval. Motion and posture information can be determined based on any electronic sensor among acceleration sensors, gyroscopes, and flexible angle sensors.

[0030] Patient activity information can be determined based on at least one of the following: heart rate sensor output, blood pressure sensor output, temperature sensor output, respiratory rate sensor output, oxygen saturation sensor output, accelerometer sensor output, gyroscope sensor output, flexible angle sensor output, clock output, geolocation information, and activity input provided by the patient.

[0031] According to an aspect of the present invention, the gastrointestinal probe includes at least one probe sensor among a pH sensor and an impedance sensor. Gastric and esophageal contents measurements are obtained based on the output of at least one probe sensor.

[0032] The advantage of obtaining GECM is that multiple probe sensors are arranged in a sequence. This makes it possible to determine the direction and speed of movement of gastroesophageal contents within the gastrointestinal tract.

[0033] According to aspects of the present invention, the sensor configured to measure parameters is one of the following sensors: a heart rate sensor, a blood pressure sensor, a temperature sensor, a respiratory rate sensor, an oxygen saturation sensor, a lactate concentration sensor, a sodium level sensor, a uric acid level sensor, a potassium concentration sensor, or a stress-related hormone sensor. Parameter measurements are obtained based on the output of sensors configured to measure the parameters.

[0034] In fact, parameters measured by various sensors are influenced by the patient's pain and / or stress levels.

[0035] According to aspects of the present invention, the system further includes a receiving wireless communication unit configured to receive gastroesophageal contents measurement values ​​(more precisely, data indicating GECM) from a gastrointestinal probe, the gastrointestinal probe includes a transmitting wireless communication unit configured to transmit gastroesophageal contents measurement values.

[0036] Therefore, data indicating GECM can be extracted from the probe being analyzed, while the probe remains located within the gastrointestinal tract.

[0037] Furthermore, the wireless communication unit may be included within a device, such as a user device (smartphone, connected watch) or a patient-worn device. Thus, the patient can live their life normally, which makes it possible to monitor the patient during their daily life, and this is relevant to establishing an accurate diagnosis.

[0038] According to another aspect of the present invention, the system includes a gastrointestinal probe, a patient-wearable device including at least one sensor configured to measure patient parameters, and a user device. The probe, patient-wearable device, and user device have wireless communication capabilities.

[0039] The user device interface (e.g., a smartphone interface) can be used to collect data related to PRS, while activity information can be read from various sensors and software already present in the smartphone. Such activity information may include meal times (start and end), meal content, sleep duration, and time spent exercising or sitting.

[0040] According to another aspect of the present invention, the system associates the level of gastrointestinal disorder with a specific gastrointestinal disorder by showing the interrelationship of events revealed by a first value and a second value.

[0041] This makes it possible to identify specific diseases within the digestive system. In fact, each digestive disease has a specific GECM and a specific PRS that are ultimately determined by the patient's activities (some specific gastrointestinal disorders have symptoms that only occur when the patient engages in certain activities (these trigger PRS)). For example, symptoms associated with a certain disease may only occur during or after a meal.

[0042] Furthermore, the system can determine another level of gastrointestinal disorder related to another gastrointestinal disorder by showing the interrelationships between the events revealed by the first and second values. The determination of another level is performed by the system in the same manner as determining the level of gastrointestinal disorder related to the other gastrointestinal disorder.

[0043] A second aspect of the present invention is a method for monitoring gastrointestinal disorders, - A step of receiving data showing the measurement of the patient's gastroesophageal contents, - A step of receiving data indicating parameter measurements, wherein the parameters depend on the patient's pain and / or stress, and - A step of receiving data indicating input from a patient, wherein the input corresponds to a patient-reported symptom (PRS), - A step of determining a set of pairs of values ​​corresponding to each set of different time intervals, wherein each pair of values ​​corresponding to a given time interval in the set of different time intervals includes a first value and a second value, If the data representing patient input corresponds to input in a given time interval, the first value is determined based on the data representing the measured value of the parameter corresponding to the given time interval and the data representing patient input corresponding to the given time interval. The second value described above is determined based on data showing measurements of gastroesophageal contents corresponding to a given time interval, in the following steps: - A step of determining the level of gastrointestinal disorder based on the set of determined values. This includes methods.

[0044] A third aspect of the present invention relates to a computer program product that includes a code instruction that performs the method described above when the instruction is performed by a processor.

[0045] A fourth aspect of the present invention is: Receiving data showing the measurement values ​​of the patient's gastroesophageal contents, This involves receiving data that shows parameter measurements, where the parameters depend on the patient's pain and / or stress. This involves receiving data indicating input from the patient, and the above input corresponds to patient-reported symptoms (PRS). A communication interface configured to perform A computer including, This involves determining a set of pairs of values ​​corresponding to each set of different time intervals, where each pair of values ​​corresponding to a given time interval in the set of different time intervals includes a first value and a second value. If the data representing patient input corresponds to input in a given time interval, the first value is determined based on the data representing the measured value of the parameter corresponding to the given time interval and the data representing patient input corresponding to the given time interval. The second value mentioned above is determined based on data showing measurements of gastroesophageal contents corresponding to a given time interval. Based on the set of determined values, the level of gastrointestinal disorder is determined. Further including a processor configured to perform the following: Regarding computers.

[0046] The present invention is described in the figures of the accompanying drawings, where similar reference numerals refer to similar elements, as examples, not as limitations. [Brief explanation of the drawing]

[0047] [Figure 1] This is a diagram of a system according to an embodiment of the present invention. [Figure 2] This is a flowchart illustrating the implementation of the system according to the present invention. [Modes for carrying out the invention]

[0048] Referring to Figure 1, a patient P is shown with a gastrointestinal probe 1 and a wearable device 11 in its gastrointestinal tract. The gastrointestinal probe 1 includes a plurality of probe sensors 2 arranged in an array. The probe sensors 2 may be pH sensors and / or impedance sensors, and these sensors output gastroesophageal contents measurements. The gastrointestinal probe 1 includes a wireless communication unit 3 configured to transmit the gastroesophageal contents measurements obtained by the probe sensors 2 to the wearable device 11.

[0049] The wearable device 11 (which could also be a user device) includes a sensor 16 configured to measure patient parameters, such as patient P's heart rate. More generally, the sensor 16 is any type of sensor that enables the measurement of pain and / or stress-dependent parameters of patient P. Several sensors may be combined to track the evolution of several pain and / or stress-dependent parameters of patient P. The sensor 16 may be a heart rate sensor, blood pressure sensor, temperature sensor, respiratory rate sensor, oxygen saturation sensor, lactate concentration sensor, sodium level sensor, uric acid level sensor, potassium concentration sensor, and stress-related hormone sensor.

[0050] The wearable device 11 includes an activity sensor 18. The activity sensor 18 may be one of the following: a heart rate sensor, a blood pressure sensor, a temperature sensor, a respiratory rate sensor, an oxygen saturation sensor, an accelerometer, a gyroscope, or a flexible angle sensor. Alternatively, the activity sensor 18 may be combined with or replaced by a watch and / or geolocation module.

[0051] The wearable device 11 includes a motion and attitude sensor 19. The motion and attitude sensor 19 may be one of an accelerometer, a gyroscope, and a flexible angle sensor. The activity sensor 18 and the motion and attitude sensor 19 may be the same sensor.

[0052] The wearable device 11 includes a patient interface 15 configured to receive input from patient P, corresponding to PRS and / or activity inputs. Activity inputs refer to information entered by patient P that indicates activity, such as sleeping or eating lunch. The wearable device 11 also includes a wireless communication module 14, a processing module 12, a memory unit 13, and a communication module 17. The memory unit 13 includes a non-volatile unit for reading computer programs and a volatile unit for reading parameters used to establish a score indicating the level of gastrointestinal disturbance, such as a predefined length of time intervals.

[0053] The wireless communication module 14 is configured to receive gastroesophageal content measurement values ​​transmitted by the wireless communication unit 3.

[0054] The wireless communication unit 3 and wireless communication module 14 can use any wireless communication technology and standard that enables wireless communication at a distance of approximately 1 meter, such as LPWAN (Lora, Sigfox), cellular (3G, 4G, 5G), mesh protocol (Zigbee), Bluetooth® and BLE, Wi-Fi or wireless auto-identification.

[0055] The communication module 17 is configured to transmit data to a computer 30 via a network 20 (for example, via the Internet using IP technology), and the computer is, for example, a doctor's computer that monitors patient P to diagnose a possible gastrointestinal disorder.

[0056] The processing module 12 is configured to determine a set of time intervals and, for each time interval, to determine a first value and a second value. The processing module 12 is also configured to determine a score indicating the level of gastrointestinal disorder. The processing module 12 is configured to determine the patient's activity and therefore activity information based on the output of the activity sensor 18 and / or the activity input. The processing module 12 is configured to determine the patient's movement and posture information based on the output of the motion and posture sensor 19.

[0057] Therefore, in the example of Figure 1, the processing module 12 performs all the calculations necessary to determine a score indicating the level of gastrointestinal disorder, but the present invention is not limited to such embodiments. Thus, some or all of the calculations necessary to determine the score are performed on the physician's computer 30 or any other computer and / or server. For example, the communication module 17 may be configured to send the measurements received from the gastrointestinal probe 1, the input PRS, and the parameter measurements to the physician's computer 30. Based on this received data, the physician's computer 30 can calculate a first value and a second value, and finally calculate a score indicating the level of gastrointestinal disorder.

[0058] Referring to Figure 2, a flowchart illustrating the implementation of the system according to the present invention is shown.

[0059] In step S1, the gastrointestinal probe 1 is placed in the gastrointestinal tract of patient P who is being monitored for gastrointestinal disorders.

[0060] In step S2, the wearable device 11 receives GECM from probe 1.

[0061] When a specific GECM event occurs, the processing module 12 determines a time interval that begins at the time the GECM event is measured. The time interval lasts for a predetermined time T. As previously mentioned, the time interval can be determined differently. For example, the duration of the time interval may be determined by the intensity or level of the GECM.

[0062] A GECM event is a significant change and / or high level of GECM, and / or duration of GECM above a certain level. For example, a GECM event is identified by the processing module 12 if the pH measured by probe sensor 2 is below a certain level, or if the measured pH decreases by a certain amount.

[0063] In step S3.1, during the time interval, the wearable device 11 measures the level and the sensor 16 tracks the evolution of the parameter.

[0064] In step S3.2, during the time interval, the wearable device 11 receives a signal from the activity sensor 18.

[0065] In step S3.3, during the time interval, the wearable device 11 receives signals from the motion and posture sensors 19.

[0066] In step S3.4, during the time interval, the wearable device 11 receives activity input from patient P via the patient interface 15.

[0067] In step S4, during the time interval, the wearable device 11 receives a patient rating system (PRS) from patient P via the patient interface 15. The PRS may be a combination of the type of symptom (e.g., heartburn, pyrosis, chest pain, belching, difficulty swallowing, reflux, or cough) and the intensity level of this symptom.

[0068] In step S5.1, the processing module 12 determines activity information based on the activity input and the signal received from the activity sensor 18. The activity information indicates the activity the patient is performing during the time interval. For example, if the activity sensor 18 is a temperature sensor, and the signal received from this temperature sensor corresponds to a low body temperature and no activity input, the activity information indicates that the patient is sleeping.

[0069] In step S5.2, the processing module 12 determines motion and posture information based on signals received from the motion and posture sensor 19. The motion and posture information is: - Indicates the patient P's posture during the time interval, for example, whether the patient is lying down or flexed forward. - Indicates the patient P's activity during the time interval, for example, showing that the patient is running, walking, playing sports, or sleeping.

[0070] In step S6, the processing module 12 determines a first value.

[0071] If a PRS is entered by patient P during the time interval, the first value is based on the entered PRS and the measured values ​​of parameters that depend on patient P's pain and / or stress.

[0072] The first value can be obtained by weighting the values ​​corresponding to the input PRS obtained by measuring the parameters. For example, the first value can be obtained by multiplying the intensity level of the symptoms experienced by patient P by a weighting coefficient. The weighting coefficient is, for example, the maximum measurement of the parameter during the time interval, normalized between 0 and 1. Therefore, if the measured level of the parameter during the time interval following the GECM event is low, the first value will be lower than the input intensity level of the symptoms experienced by patient P. Conversely, if the measured level of the parameter during the time interval following the GECM event is high, the first value will be higher than the input intensity level of the symptoms experienced by patient P.

[0073] Furthermore, the first value can be obtained by weighting the parameter measurements from the input PRS. For example, the first value can be obtained by multiplying the maximum measurement of the parameter during the time interval by a weighting coefficient. The weighting coefficient is, for example, the input intensity level of the symptoms experienced by patient P, normalized between 0 and 1. Therefore, if the patient experienced low-intensity symptoms during the time interval following the GECM event, the first value will be smaller than the maximum measurement of the parameter during the time interval. Conversely, if the patient experienced high-intensity symptoms during the time interval following the GECM event, the first value will be larger than the maximum measurement of the parameter during the time interval.

[0074] If patient P did not input a PRS during the time interval, the first value is based on measurements of pain and / or stress-dependent parameters of patient P. For example, the first value is the maximum measurement of the parameter during the time interval.

[0075] As mentioned above, the maximum measured value of the parameter is used to obtain the first value. However, any other relevant value related to the parameter's measured value may be used. For example, the mean level of the parameter over a time interval may be used in the same way.

[0076] In step S7, the processing module 12 determines a second value based on the gastroesophageal contents measurements taken in step S2. For example, to a GECM detected as a GECM event.

[0077] If the activity information and the motion and posture information are determined to be events in steps S5.1 and S5.2, the second value is determined based on the GECM measured in step S2 and on this patient activity information and / or motion and posture information. For example, the processing module 12 obtains the second value by multiplying the GECM value measured in step S2 by a weighting coefficient, which is based on the patient activity information and / or motion and posture information. For example, a mapping may be established in advance by assigning weighting coefficients to each possible triplet of activity, posture, and motion. Thus, based on the activity, the posture and motion are indicated by the patient activity information and motion and posture information, and the processing module 12 can read and apply the relevant weighting coefficients.

[0078] If activity information and motion and posture information, which are not shown in Figure 2 for the sake of brevity, cannot be determined, the second value is determined by the processing module 12 based solely on the GECM measured in step S2. For example, the second value may be determined as the GECM value measured in step S2.

[0079] In S2, several values ​​of GECM may be measured, meaning that several measurements may be performed during the time interval. This is especially true when using a system that performs high-frequency measurements of gastroesophageal contents. In such cases, the GECM used to calculate the second value may be any combination of GECMs measured during the time interval, for example, the maximum GECM measured during the time interval, the average of the GECMs measured during the time interval, and the GECMs identified as GECM events.

[0080] Steps S1 through S7 are performed iteratively to obtain a sequence of pairs of first and second values, where each pair of values ​​corresponds to its own time interval. Each iteration may include a new time interval, even if these time intervals may intersect.

[0081] In step S8, the processing module 12 determines the level of gastrointestinal disorder, for example, by determining a score related to the level of gastrointestinal disorder.

[0082] For example, for each pair of first and second values, a third value is obtained, which is determined by multiplying the first value by a weighting coefficient. The weighting coefficient may be, for example, the second value (normalized between 0 and 1). The sequence of third values ​​obtained for each sequence of first and second value pairs is then compared to the sequence of patients whose gastrointestinal disorders have been previously analyzed and diagnosed. The more the sequence of third values ​​resembles the sequence corresponding to a particular gastrointestinal disorder, the higher the score associated with the level of gastrointestinal disorder is likely to be.

[0083] More generally, the score can be determined based on known methods that can correlate the conventional PRS and GECM. In the present invention, these methods are used instead with a first value and a second value. [Explanation of Symbols]

[0084] 1. Gastrointestinal probe 2 Probe Sensors 3 Wireless communication unit 11 Wearable Devices 12 Processing Modules 13 memory units 14 Wireless communication module 15. Patient Interface 16 sensors 17. Communication Module 18 Activity Sensors 19. Motion and attitude sensors 20 Networks 30 Computers P patient T (Specified time)

Claims

1. It is a system for monitoring gastrointestinal disorders. A gastrointestinal probe configured to measure the contents of a patient's stomach and esophagus, At least one sensor configured to measure the parameters of the patient, wherein the parameters are associated with one or more of the patient's pain and stress, A patient interface configured to receive input from the patient, wherein the input corresponds to a patient-reported symptom (PRS), and It is a processor, This involves determining a set of pairs of values ​​corresponding to each set of different time intervals, where each pair of values ​​corresponding to a given time interval in the set of different time intervals includes a first value and a second value. If the input from the patient corresponds to the given time interval, the first value is determined based on the measured value of the parameter corresponding to the given time interval and based on the input from the patient corresponding to the given time interval. The second value is determined based on the measured values ​​of gastroesophageal contents corresponding to the given time interval, and The level of gastrointestinal disorder is determined based on the set of pairs of values ​​determined above. A processor and A system that includes this.

2. The first value determined based on the measured values ​​of the parameters and the input from the patient is Adding weights to the measured values ​​of the parameters based on the input from the patient, or Adding weights to the values ​​corresponding to the input from the patient based on the measured values ​​of the aforementioned parameters. The system according to claim 1, determined by...

3. The system according to claim 1 or 2, wherein if there is no input from the patient corresponding to the given time interval, the processor is further configured to determine the first value based on the measured value of the parameter corresponding to the given time interval.

4. The system according to any one of claims 1 to 3, wherein the second value is determined based on the measurement of gastroesophageal contents corresponding to the given time interval and based on one or more patient activity information and movement and posture information, the patient activity information and the movement and posture information corresponding to the given time interval.

5. The system according to claim 4, wherein the second value, determined based on the measured value of the gastroesophageal contents and based on the patient activity information and / or the movement and posture information, is determined by weighting the measured value of the gastroesophageal contents based on the patient activity information and / or the movement and posture information.

6. The system according to claim 4 or 5, comprising at least one electronic sensor from among an accelerometer, a gyroscope, and a flexible angle sensor, wherein the motion and attitude information is determined based on the output of the at least one electronic sensor.

7. The system according to any one of claims 4 to 6, wherein the patient activity information is determined based on at least one of the following: the output of a heart rate sensor, the output of a blood pressure sensor, the output of a temperature sensor, the output of a respiratory rate sensor, the output of an oxygen saturation sensor, the output of an acceleration sensor, the output of a gyroscope sensor, the output of a flexible angle sensor, the output of a clock, geolocation information, and activity inputs provided by the patient.

8. The gastrointestinal probe includes at least one probe sensor, which is a pH sensor and an impedance sensor. The system according to any one of claims 1 to 7, wherein the measurement value of the gastroesophageal contents is obtained based on the output of the at least one probe sensor.

9. The gastrointestinal probe includes a plurality of probe sensors arranged in an array, The measurement values ​​of the gastric and esophageal contents are obtained based on the outputs of the plurality of probe sensors. The system according to claim 8.

10. The sensor configured to measure the aforementioned parameters is one of the following sensors: heart rate sensor, blood pressure sensor, temperature sensor, respiratory rate sensor, oxygen saturation sensor, lactate concentration sensor, sodium level sensor, uric acid level sensor, potassium concentration sensor, or stress-related hormone sensor. The system according to any one of claims 1 to 9, wherein the parameter measurement is obtained based on the output of the sensor configured to measure the parameter.

11. The system according to any one of claims 1 to 10, further comprising a receiving wireless communication unit configured to receive gastroesophageal contents measurements from the gastrointestinal probe, wherein the gastrointestinal probe includes a transmitting wireless communication unit configured to transmit gastroesophageal contents measurements.

12. The system according to claim 11, further comprising a device including the receiving wireless communication unit and / or the patient interface, wherein the device is a user device or a patient-worn device.

13. The system according to any one of claims 1 to 12, further comprising associating the level of the gastrointestinal disorder with a first gastrointestinal disorder and determining another level of gastrointestinal disorder associated with a second gastrointestinal disorder, wherein the other level is determined based on a set of pairs of the determined values.

14. A method for monitoring gastrointestinal disorders by a system for monitoring gastrointestinal disorders, which includes a processor, The processor receives data indicating the measurement of the patient's gastroesophageal contents, The steps include: receiving data indicating parameter measurements by the processor, wherein the parameters are associated with one or more of the patient's pain and stress; The steps include: receiving data from the patient, wherein the input corresponds to a patient-reported symptom (PRS), using the aforementioned processor; The processor determines a set of pairs of values ​​corresponding to each set of different time intervals, wherein each pair of values ​​corresponding to a given time interval in the set of different time intervals includes a first value and a second value. If the data indicating the input from the patient indicates an input corresponding to the given time interval, the first value is determined based on the data indicating the measured value of the parameter corresponding to the given time interval and based on the data indicating the input from the patient corresponding to the given time interval. The second value is determined based on data showing measurements of gastroesophageal contents corresponding to the given time interval, in steps: The processor performs the steps of determining the level of gastrointestinal disorder based on the set of determined values. Methods that include...

15. A computer program product comprising, when the program is executed by at least a processor, a code instruction causing the processor to perform the method according to claim 14.

16. Receiving data showing the measurement values ​​of the patient's gastroesophageal contents, The receiving of data indicating parameter measurements, where the parameters are associated with one or more of the patient's pain and stress, The process involves receiving data indicating input from the patient, where the input corresponds to patient-reported symptoms (PRS). A computer including a communication interface configured to perform, This involves determining a set of pairs of values ​​corresponding to each set of different time intervals, where each pair of values ​​corresponding to a given time interval in the set of different time intervals includes a first value and a second value. If the data indicating input from the patient indicates input corresponding to the given time interval, the first value is determined based on the data indicating the measured value of the parameter corresponding to the given time interval and based on the data indicating input from the patient corresponding to the given time interval. The second value is determined based on data showing measurements of gastroesophageal contents corresponding to the given time interval. Based on the set of pairs of values ​​determined above, the level of gastrointestinal disorder is determined. A computer that further includes a processor configured to perform the following tasks.

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