An apparatus for detecting upper gastrointestinal transit function

Abstract

The application provides an upper gastrointestinal tract transport function detection device, which is provided with a functional device on a flexible core body; the functional device comprises an embeddable sensor, an impedance electrode, a microprocessor and a wireless module; the flexible core body can be swallowed through the oral cavity or inserted into the gastrointestinal tract for transport function detection, transport characteristic parameter collection is completed, and detection of different aspects of gastrointestinal function is realized; the embeddable sensor collects data through a storage chip or a matched external wireless receiver. The application adopts a bionic structure design, has the characteristics of being easy to swallow and inserted into the esophagus, can detect key parameters including axial pressure, acceleration and orientation, and further calculates various transport indexes and pressures at specific times and positions through the key parameters, solves the problems of function detection of esophageal tortuosity, transport acceleration, speed and trajectory, and meets the functional requirements of organic lesion and sensory function diagnosis by obtaining the information and the esophageal pressure and symptom related characteristics.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a device for detecting upper gastrointestinal transport function. Background Technology

[0002] The primary function of the upper digestive tract is to transport food or liquids to distal sites for consumption and absorption. For example, the esophagus transports swallowed substances to the stomach for further breakdown. Esophageal peristalsis is divided into primary and secondary peristalsis. Primary peristalsis is caused by swallowing, while secondary peristalsis is caused by other factors (such as acid reflux or esophageal distension). The function of the esophagus and other gastrointestinal segments / organs can be affected by disease or dysfunction. Gastroesophageal reflux disease (GERD) is a common upper digestive tract disorder characterized by symptoms such as heartburn. This may be related to esophageal motility, sphincter relaxation, or a straight gastroesophageal junction. Another common disorder is esophageal-gastric outflow tract obstruction (EGJOO), which is more common in middle-aged and older women aged 51-69, with dysphagia being the most common symptom. EGJOO can be caused by various conditions, such as mechanical obstruction, hiatal hernia, incomplete peristalsis, and achalasia.

[0003] Traditional esophageal function is typically assessed using manometry catheters, which is currently the gold standard. Esophageal manometry provides information on esophageal muscle contraction characteristics but cannot delve deeply into flow patterns. In addition, fluoroscopic imaging and EndoFLIP are two other important techniques for esophageal function assessment; fluoroscopic imaging provides some information on flow characteristics but lacks other parameter information. EndoFLIP can simultaneously measure esophageal pressure and lumen diameter, but neither of these techniques provides important functional information such as esophageal tortuosity, transport acceleration, and velocity, nor the characteristics of these information related to esophageal pressure and symptoms. Another important type of assessment technique is "smart pills," which can measure pressure and pH information and sometimes provide imaging information on gastrointestinal transit (e.g., capsule endoscopy); however, they are not suitable for assessing rapid esophageal transport models. Summary of the Invention

[0004] In view of the above-mentioned shortcomings of the existing technology, the purpose of the present invention is to provide an upper gastrointestinal transport function detection device, which solves the problem that the existing detection devices cannot perform functional detection of esophageal tortuosity, transport acceleration, speed and orientation, and provides information related to esophageal pressure and symptoms to meet the functional requirements of organic lesion and sensory function diagnosis.

[0005] To achieve the above objectives, the present invention employs the following technical means:

[0006] A device for detecting upper gastrointestinal transport function includes a flexible core with functional components mounted on it. These components include an embedded sensor, impedance electrodes, a microprocessor, and a wireless module. The flexible core can be used for transport function detection via oral swallowing or insertion into the digestive tract, acquiring transport characteristic parameters and enabling detection of different aspects of digestive tract function. The embedded sensor collects data via a storage chip or a matched external wireless receiver. The external wireless receiver is portable.

[0007] Furthermore, the embeddable sensor includes several pressure sensors, several motion sensors, several impedance electrodes, etc.; at least one motion sensor is used for detecting the movement trajectory of the device in the digestive tract, and at least two are used for detecting the bending angle of the device. The embeddable sensor is distributed along the axial direction on the flexible core.

[0008] The flexible core is formed by integrating one or more flexible sections with a compact, non-flexible section containing functional components, creating a columnar body with the same diameter. The flexible core is also composed of multiple short, rigid sections interconnected by thin, flexible tubing. The tubing is covered by an expandable sheath, which expands to the same diameter as the rigid sections by injecting liquid or gel into the sheath.

[0009] Furthermore, the flexible core is bendable and covered with an acid-resistant material (i.e., a loose or tight thin film capsule) to ensure that gastric acid does not come into contact with the internal components in the highly acidic environment of the stomach.

[0010] Furthermore, the flexible core is encased in an expandable balloon; the flexible core also has a valved infusion channel, which is connected to a detachable infusion conduit.

[0011] Furthermore, the detachable infusion catheter consists of an outer tube and an inner infusion tube; the outer tube generates a reverse force to completely or partially separate the inner infusion tube from the flexible core, and the partially separated infusion catheter is made of a soluble material.

[0012] Furthermore, the device employs real-time activation and delayed activation (i.e., not immediately upon swallowing or insertion); delayed activation methods include waking up after a preset time and activation via current and / or magnetic field to meet the needs of detecting distal gastrointestinal sites outside the esophagus; the corresponding collection methods are real-time or delayed modes.

[0013] Furthermore, the data measured by the sensor can be fused:

[0014] Method for calculating the fusion index of mechanical and morphological properties (GIP):

[0015] GIP = A × CSA / P

[0016] In the formula, A is the curvature, CSA is the cross-sectional area of ​​the balloon, and P is the pressure;

[0017] GIP is used to reflect the functional relationship between the curvature of the digestive tract, the shape of the cavity and the peristaltic force during transportation. It can be used to analyze the correlation between the angle His between the esophagus and the fundus of the stomach and the morphology and mechanical properties of the lower esophageal sphincter.

[0018] Calculation method of fusion index EGJIP:

[0019] EGJIP=V × (P r - P f ) / CSA / A,

[0020] In the formula, V is the transport speed, and P is the transport speed. r It's backend pressure, P f It's front-end pressure;

[0021] EGJIP is used to illustrate the functional relationship between the transport speed of contents, effective creep force, cavity shape and curvature during transportation.

[0022] Compared with the prior art, the present invention has the following beneficial effects:

[0023] 1. The upper digestive tract transport function detection device provided by this invention adopts a biomimetic structural design and is a flexible and bendable device, characterized by its swallowability and easy insertion into the esophagus. The device can detect various parameters during digestive tract transport, including key parameters such as axial pressure, acceleration, and orientation. These key parameters are then used to further calculate various transport indices and forces at specific times and locations. Examples of sensing technologies that the device can implement include impedance measurement, pH recording, mucosal conductivity, video imaging, ultrasonic transducers, and thermal resistors.

[0024] 2. This device can be used to detect different aspects of esophageal function through various detection methods. For example, when the device is swallowed, primary peristalsis in the oropharynx and esophageal passage can be detected; it can also be inserted into the esophagus through the mouth or swallowed, and connected to the device via a thin thread or catheter, allowing it to remain in the esophagus for a short period. During this period, the external balloon of the device can be expanded to detect secondary peristalsis; furthermore, after balloon expansion, the connecting catheter can be disconnected immediately or after a period of time, thereby achieving the detection of transport characteristics based on secondary peristalsis. All tests can be performed in any body position, such as lying down, sitting, or standing.

[0025] 3. The data transmission of this invention is wireless, avoiding the parameter abnormalities caused by discomfort to the subject due to external tubing. Simultaneously, the detachable infusion tube design allows the device to effectively stimulate secondary peristalsis in the digestive tract, effectively compensating for the functional deficiencies of existing swallowable capsule devices, and achieving true wireless biomimetic detection of digestive tract transport functions.

[0026] 4. This invention proposes two parameters for comprehensively evaluating the characteristics of digestive tract transport, effectively realizing the fusion evaluation of mechanical, morphological and kinematic characteristics.

[0027] 5. Most of the functions of this device are related to the detection of esophageal transport function, and therefore it is suitable for the detection of transport and motility in the stomach and intestines. Attached Figure Description

[0028] Figure 1 This is a schematic diagram of the device structure of Embodiment 1 of the present invention; wherein, 90-battery; 95-membrane outer capsule; 101-flexible core; 102-balloon; 103-pressure sensor; 104-motion sensor; 105-microprocessor and wireless module; 106-infusion channel with valve; 107-impedance electrode.

[0029] Figure 2 This is a schematic diagram of the device structure in Embodiment 2 of the present invention; wherein, 108 - inflexible end one; 109 - inflexible end two; 110 - flexible middle part.

[0030] Figure 3 This is a schematic diagram of the device structure of Embodiment 3 of the present invention; wherein, 151-rigid head; 152-rigid middle part; 153-rigid tail; 154-flexible pipeline; 155-expandable sheath.

[0031] Figure 4 This is a flowchart of the detection process of the device of the present invention.

[0032] Figure 5 This is a schematic diagram of an embodiment of the device for detecting the upper digestive tract transport function of the present invention; wherein, 1-detection probe; 2-esophagus; 3-angle between the esophagus and the fundus of the stomach (His angle); 4-lower esophageal sphincter; 5-stomach.

[0033] Figure 6 This is a schematic diagram of an embodiment of the device for detecting the upper digestive tract transport function of the present invention; wherein, 6-probe with balloon (undilated); 7-removable catheter; 8-probe with balloon (dilated); 9-infusion fluid.

[0034] Figure 7 This is a schematic diagram of data transmission of the device of the present invention; wherein, 10 - external wireless receiver.

[0035] Figure 8 This is a detachable embodiment of the infusion catheter of the present invention; wherein, 201-outer tube; 202-infusion inner tube; 213-direction of force of the inner tube during disassembly; 214-direction of force of the outer tube during disassembly. Detailed Implementation

[0036] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments.

[0037] See Figure 1 and Figure 2 This invention provides an upper digestive tract transport function detection device, comprising a flexible core 101 equipped with multiple embedded sensors, including a pressure sensor 103, a motion sensor 104, a microprocessor, and a wireless module 105; the pressure sensor 103 and motion sensor 104 are located at both ends of the flexible core 101, and the microprocessor and wireless module 105 are located in the middle of the flexible core 101; a battery is disposed between the sensors at both ends and the microprocessor and wireless module 105 in the middle; a plurality of impedance electrodes 107 are distributed on the outer surface of the flexible core 101.

[0038] The device incorporates various embedded sensors (such as pressure and motion sensors) to acquire diverse motion and mechanical data for organ transport and contraction detection. Motion sensors, including accelerometers, gyroscopes, and magnetometers, calculate the device's orientation, curvature, velocity, and position, enabling high-precision assessment of the device's transport trajectory within the organ. At least one motion sensor is used for transport trajectory assessment, and at least two motion sensors are used for curvature measurement. In addition to the preferred embodiment, the device can embed any other micro-sensors, such as impedance and conductivity sensors, pH sensors, cameras, ultrasonic resonators, thermal resistors, and chemical sensors; this list of feasible sensor technologies is not exhaustive. The device has multiple sampling frequencies, with a preferred implementation frequency of 50–100 Hz in the esophagus, and lower or higher frequencies in other locations.

[0039] Furthermore, the two ends of the flexible core 101 are rigid, inflexible ends (108, 109); the middle part is a flexible, bendable middle part 110 made of flexible material; the two ends and the middle part of the flexible core 101 are fixedly connected to each other to form a columnar body with the same diameter. In a preferred embodiment, the flexible core 101 is made of medical flexible material, which includes pressure sensors distributed along the axial direction (direction of motion trajectory), and motion sensors are arranged at both ends; the rigid, inflexible ends (108, 109) are made of medical polymer material.

[0040] Furthermore, the impedance electrode 107 on the flexible core 101 has different functions depending on whether it is wrapped by the balloon 102. In the embodiment wrapped by the balloon 102, the impedance electrode 107 is used for measuring the impedance cross-sectional area of ​​the balloon; in the embodiment without the balloon 102, the impedance electrode 107 is used for measuring the impedance of the digestive tract.

[0041] The device of the present invention is made of materials that are safe for the human body and needs to be designed to be resistant to strong acids to ensure that gastric acid will not come into contact with the internal materials of the device in the strong acid environment of the stomach; the flexible core 101 is covered with an acid-resistant material (i.e., a loose or tight thin film capsule 95).

[0042] See Figure 3 The flexible core 101 is composed of multiple short rigid parts (151, 152, 153) connected to each other. The parts are connected by thin flexible tubes 154. The outer wall of the tubes is covered by an expandable sheath 155, which can be expanded to the same diameter as the rigid parts by injecting liquid or gel into the sheath. Depending on the mechanical properties of the injected liquid or gel, a variety of different food bolus characteristics can be simulated.

[0043] See Figure 4 When using the device of this invention, if it is necessary to detect distal gastrointestinal tract sites outside the esophagus, it can perform delayed activation, that is, activation is not performed immediately upon swallowing or insertion. This method can be set according to the site of interest. For example, for the small intestine, it is most reasonable to start information collection 2-3 hours after it passes through the stomach. Activation can be performed in different ways, including waking up after a preset time, or activation by electric current or magnetic field.

[0044] In a preferred embodiment, data is acquired in real time and displayed on an electronic device such as a computer, laptop, tablet, or smartphone. This allows for the analysis and / or clinical diagnosis of various important parameters. The types of analysis and diagnosis include pre- and post-pressure differences, gravitational field angles, velocity and position as a function of time, device bending, pressure-acceleration relationships, force and stress calculations, preload-afterload load diagrams of pressure and / or cavity diameter measurements, transmission parameters, velocity and pressure and acceleration endpoints, etc. (the list is not exhaustive).

[0045] Depending on the number and type of sensors included in the device, the data measured by the device undergoes various processing types and methods. This ranges from simple direct recording (such as pressure changes over time after swallowing or esophageal insertion) to complex algorithms. For example, patients with gastroesophageal reflux disease (GERD) have weaker lower esophageal sphincter muscles, and their gastroesophageal junction (EGJ) may be straighter than normal (with a smaller His angle). Therefore, when the device passes through the lower esophagus and EGJ, it measures a smaller curvature A, a larger lumen diameter CSA, and a lower pressure P. This can be integrated into a more advanced index algorithm, the GERD index (GIP), where GIP = A × CSA / P.

[0046] The processing methods also include indicative parameters obtained from analysis and numerical simulation. For diseases of the gastroesophageal junction such as esophageal-gastric outflow tract obstruction (EGJOO) and achalasia, other algorithms are used for data analysis to provide indicators for clinical diagnosis. In EGJOO, the pressure at the front end of the device is generally higher, the acceleration and velocity at the lower esophagus are slower, and the diameter decreases. Furthermore, if esophageal dilation occurs, the device may become lodged in the lower esophagus. When this happens, the device's orientation may deviate from the axial direction and shift radially. This characteristic can be observed by plotting the simple raw parameters as a color profile. Analysis of all the parameters mentioned above can also be performed on the color profile, including: EGJIP index = V × (P r - P f Other analyses may include esophageal wall friction (transport resistance) based on the balance equation of transport forces.

[0047] The data measured by the sensors can be fused and processed.

[0048] Method for calculating the fusion index of mechanical and morphological properties (GIP):

[0049] GIP = A × CSA / P

[0050] In the formula, A is the curvature, CSA is the cross-sectional area of ​​the balloon, and P is the pressure;

[0051] GIP is used to reflect the functional relationship between the curvature of the digestive tract, the shape of the cavity and the peristaltic force during transportation. It can be used to analyze the correlation between the angle His between the esophagus and the fundus of the stomach and the morphology and mechanical properties of the lower esophageal sphincter.

[0052] Calculation method of fusion index EGJIP:

[0053] EGJIP=V × (P r - P f ) / CSA / A,

[0054] In the formula, V is the transport speed, and P is the transport speed. r It's backend pressure, P f It's front-end pressure;

[0055] EGJIP is used to illustrate the functional relationship between the transport speed of contents, effective creep force, cavity shape and curvature during transportation.

[0056] Further, see Figure 1 The device of the present invention may also include an expandable balloon 102 wrapped around the flexible core 101, and the flexible core 101 is provided with a valved injection channel 106 inside.

[0057] See Figure 5 This is a schematic diagram of an embodiment of the device for detecting the transport function of the upper digestive tract in this invention. The detection device 1 enters through the esophagus 2 at the angle 3 between the esophagus and the fundus of the stomach (His angle), then proceeds to the lower esophageal sphincter 4 and the stomach 5. The device can collect relevant information during its movement. This device is swallowable or inserted orally. Compared to other swallowable devices used to record gastrointestinal motility and pH levels, this device is flexible, soft, or contains one or more soft parts; its preferred size is 4-6 cm long and 6-8 mm in diameter, but it can also be larger or smaller. Experiments show that soft, flexible objects (such as gummies) 6-7 cm long and 6-8 mm in diameter are easy to swallow and do not cause serious discomfort. The residence time and expulsion method of this device in the body are the same as ordinary functional capsule devices. After being swallowed or inserted orally, it passes through the entire digestive tract and is expelled through the anus, a process that takes approximately 19-36 hours.

[0058] See Figure 6 This is a schematic diagram of an embodiment of the device for detecting the transport function of the upper digestive tract in this invention. In some embodiments of the device that are expandable or capable of performing impedance measurement, the surface of the device is covered with a balloon; in other embodiments, the balloon covering may not be necessary. The infusion channel connecting the balloon and the catheter of the device includes a valve to prevent the liquid inside the balloon from escaping. The device with the balloon (unexpanded) 6 expands the balloon through a detachable catheter 7, and the balloon (expanded) 8 caused by the infusion of liquid 9 stimulates secondary peristalsis in the digestive tract, and the detachable catheter 7 can be automatically disconnected.

[0059] See Figure 7This is a detachable embodiment of the infusion catheter of the present invention; in some embodiments, particularly those with a balloon, the device is connected by a catheter that can be used for liquid infusion to inflate the balloon; infusion can be performed before swallowing or after swallowing or insertion into the target position. In a preferred embodiment, the catheter can be disassembled by a simple mechanism (including reverse force, magnetic force, pre-clamping, etc.), for example, using an outer tube to generate a reverse force to separate the catheter from the device; the catheter and part of the catheter can also remain connected to the device, in which case the tube can be made of a self-dissolving material, for example, dissolving after 10 minutes; wherein, the outer tube is 201, the infusion inner tube is 202; the direction of force on the inner tube during disassembly is 213, and the direction of force on the outer tube during disassembly is 214.

[0060] In addition, the device system necessarily includes an external wireless receiver (except in embodiments with a storage chip, where device data is collected after discharge); the external wireless receiver can be of various forms and shapes; in a preferred embodiment, the external wireless receiver is portable and can be placed in multiple locations depending on the receiving power, such as on the abdominal skin near the stomach, on the abdominal skin near the intestines, etc.; in a preferred embodiment, the device is wireless and includes one or more batteries; these batteries can be rechargeable batteries to provide longer operating time.

[0061] The detection process is as follows: The device is first activated to start sensor data acquisition. Then, by swallowing or inserting into the esophagus, the device is positioned at the detection location with the assistance of a thin wire or irrigation catheter. Balloon irrigation is performed, the irrigation catheter is separated, and the device enters the stomach through the esophagus. The data is then wirelessly transmitted to an external wireless receiver.

[0062] The detection process can be implemented in a variety of ways, depending on the device’s functional structure, different activation methods, data transmission methods, and the purpose of the detection.

[0063] See Figure 8 This is a schematic diagram of data transmission of the device of the present invention; wherein, 10 is an external wireless receiver. In a preferred embodiment, data is transmitted wirelessly from the stomach or other parts of the gastrointestinal tract, and the transmission form includes real-time transmission or delayed transmission; in other embodiments, the data may be stored on a storage chip and can be retrieved after the device is expelled from the body.

[0064] This invention employs a biomimetic structural design, featuring easy swallowing and insertion into the esophagus. It can detect key parameters including axial pressure, acceleration, and orientation, and further calculate various transmission indices and forces at specific times and locations using these key parameters. This solves the problem of functional detection of esophageal tortuosity, transport acceleration, velocity, and trajectory, and obtains these information and esophageal pressure and symptom-related characteristics to meet the functional needs of organic lesion and sensory function diagnosis.

[0065] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit the technical solutions. Those skilled in the art should understand that any modifications or equivalent substitutions to the technical solutions of the present invention without departing from the spirit and scope of the present invention should be covered within the scope of the claims of the present invention.

Claims

1. A device for detecting upper digestive tract transport function, characterized in that, It includes a flexible core on which functional devices are mounted; the functional devices include an embedded sensor, a microprocessor, and a wireless module; the flexible core can be swallowed through the mouth or inserted into the digestive tract to detect transport function, complete the acquisition of transport characteristic parameters, and realize the detection of different aspects of digestive tract function; the embedded sensor collects data through a storage chip or a matched external wireless receiver; The embeddable sensor includes several pressure sensors, several motion sensors, and several impedance electrodes; at least one motion sensor is used to detect the movement trajectory of the device in the digestive tract, and at least two motion sensors are used to detect the bending angle of the device. The embeddable sensor is axially distributed on a flexible core. The flexible core is composed of multiple short rigid parts connected to each other, and the parts are connected by thin flexible tubing. The outer wall of the tubing is covered with an expandable sheath, which expands to the same diameter as the rigid parts by injecting liquid or gel into the sheath. The flexible core is flexible and covered with an acid-resistant material to ensure that gastric acid does not come into contact with the internal components in the highly acidic environment of the stomach. The flexible core is encased in an expandable balloon. The data measured by the embedded sensor can be fused: Among them, the calculation method of the mechanical and morphological fusion index GIP is as follows: GIP = A × CSA / P In the formula, A is the curvature, CSA is the cross-sectional area of ​​the balloon, and P is the pressure; GIP is used to reflect the functional relationship between the curvature of the digestive tract, the shape of the cavity and the peristaltic force during transportation. It can be used to analyze the His angle between the esophagus and the fundus of the stomach and the correlation between the morphology and mechanical properties of the lower esophageal sphincter. Calculation method of fusion index EGJIP: EGJIP=V × (P r - P f ) / CSA / A, In the formula, V is the transport speed, and P is the transport speed. r It's backend pressure, P f It's front-end pressure; EGJIP is used to illustrate the functional relationship between the transport speed of contents, effective creep force, cavity shape and curvature during transportation.

2. The upper digestive tract transport function detection device according to claim 1, characterized in that, The flexible core is formed by integrating one or more bendable portions with a compact, inflexible portion containing functional components to form a columnar body with the same diameter.

3. The upper digestive tract transport function detection device according to claim 1, characterized in that, The flexible core is also provided with a valved injection channel, which is connected to a detachable injection conduit.

4. The upper digestive tract transport function testing device according to claim 3, characterized in that, The detachable infusion catheter consists of an outer tube and an inner infusion tube; the outer tube generates a reverse force to completely or partially separate the inner infusion tube from the flexible core, and the partially separated infusion catheter is made of a soluble material.

5. The upper digestive tract transport function testing device according to claim 1, characterized in that, Real-time activation and delayed activation are employed; delayed activation methods include wake-up after a preset time and activation by current and / or magnetic field to meet the needs of detecting distal gastrointestinal sites outside the esophagus; the corresponding collection methods are real-time or delayed modes.

6. The upper digestive tract transport function detection device according to claim 1, characterized in that, The external wireless receiver is portable.

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