CN116649915B

CN116649915B - A device for detecting upper gastrointestinal transport function

Info

Publication number: CN116649915B
Application number: CN202310742334.5A
Authority: CN
Inventors: 孙大明; 汉斯·格里格森
Original assignee: Chongqing Gaobo Ruiqi Technology Development Co ltd
Current assignee: Chongqing Gaobo Ruiqi Technology Development Co ltd
Priority date: 2023-06-21
Filing date: 2023-06-21
Publication date: 2025-11-25
Anticipated expiration: 2043-06-21
Also published as: CN116649915A

Abstract

This invention provides a device for detecting upper gastrointestinal transport function, comprising functional components mounted on a flexible core. These components include an embedded sensor, impedance electrodes, a microprocessor, and a wireless module. The flexible core can be swallowed or inserted into the digestive tract for transport function detection, acquiring transport characteristic parameters and enabling the detection of different aspects of digestive tract function. The embedded sensor collects data via a storage chip or a matched external wireless receiver. 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 transport indices and pressures at specific times and locations using these parameters. This addresses the problem of functional detection of esophageal tortuosity, transport acceleration, velocity, and trajectory, and obtains this information along with esophageal pressure and symptom-related characteristics to meet the functional needs of diagnosing organic lesions and sensory functions.

Description

Upper digestive tract transportation function detection device

Technical Field

The invention relates to the technical field of medical equipment, in particular to an upper digestive tract transportation function detection device.

Background

The primary function of the upper digestive tract is to transport food or fluid to the distal end for consumption and absorption. For example, the esophagus transports the swallowed material to the stomach for further breakdown. Esophageal peristalsis is divided into primary peristalsis and secondary peristalsis. Primary peristalsis is caused by swallowing, while secondary peristalsis is caused by other means (e.g., gastric acid reflux or esophageal distension stimulation, etc.). The function of the esophagus and other gastrointestinal segments/organs may be affected by disease or dysfunction. Gastroesophageal reflux disease (GERD) is a common upper gastrointestinal disorder and patients have symptoms such as burning stomach. This may be related to esophageal movement, sphincter relaxations, or flatness of the gastroesophageal junction. Another common disorder is esophageal gastric outflow obstruction (EGJOO), commonly found in middle-aged and elderly women aged 51-69 years, the most common symptom being dysphagia. Many conditions can lead to EGJOO, such as mechanical obstruction, hiatus hernia, incomplete peristalsis, and achalasia.

Conventional esophageal function is typically tested using a pressure catheter, which is the current gold standard. Esophageal manometry provides esophageal muscle contraction characteristic information, but does not explore the flow pattern deeply. Furthermore, perspective imaging technology and EndoFLIP are two other important technologies for esophageal function detection, and perspective imaging can provide some characteristic information about fluidity, but lacks other parameter information. EndoFLIP can simultaneously detect the esophageal pressure and the cavity diameter, but none of these techniques can provide important functional information about esophageal flexibility, transport acceleration and speed, and features related to esophageal pressure and symptoms. Another important class of detection techniques are "smart pills" which can perform pressure and pH information detection and sometimes also provide image information during gastrointestinal transport (such as capsule endoscopes), but they are not suitable for detection of rapid transit models of the esophagus.

Disclosure of Invention

In view of the above-mentioned shortcomings of the prior art, the present invention aims to provide an upper gastrointestinal tract transportation function detection device, which solves the problem that the existing detection device cannot perform function detection on the bending property, the transportation acceleration, the speed, the direction and the like of the esophagus, and the related characteristics of the information and the esophagus pressure and symptoms so as to meet the functional requirements of organic lesions and perception function diagnosis.

The invention adopts the following technical means:

The upper digestive tract transportation function detection device comprises a flexible core body, wherein a functional device is arranged on the flexible core body, the functional device comprises an embeddable sensor, an impedance electrode, a microprocessor, a wireless module and the like, the flexible core body can be swallowed through an oral cavity or inserted into a digestive tract to carry out transportation function detection, transportation characteristic parameter collection is completed, detection of different aspects of digestive tract functions is achieved, and the embedded sensor collects data through a storage chip or a matched external wireless receiver. Wherein the external wireless receiver is portable.

The embedded sensor comprises a plurality of pressure sensors, a plurality of motion sensors, a plurality of impedance electrodes and the like, wherein at least one motion sensor is used for detecting the motion track of the device in the alimentary canal, at least two motion sensors are used for detecting the bending angle of the device, and the embedded sensors are axially distributed on the flexible core body.

The flexible core body is formed by connecting one or more bendable parts and a non-bendable part which is compact in structure and contains functional components into a whole, so that a columnar body with the same diameter is formed. The flexible core is formed by interconnecting a plurality of short and small rigid parts, the parts are connected by thinner flexible pipelines, the outer wall of each pipeline is covered by an expandable sleeve, and the flexible core is expanded to the same diameter as the rigid parts by pouring liquid or gel into the sleeve.

Further, the flexible core is flexible, with the exterior being covered with an acid resistant material (i.e., a loose or tight film outer pouch) to ensure that the gastric acid does not come into contact with the internal components in the strong acid environment of the stomach.

Further, the flexible core body is wrapped by an expandable saccule, and is also provided with a pouring channel with a valve, and the pouring channel with the valve is connected with a detachable pouring catheter.

The detachable perfusion catheter is composed of an outer tube and an inner perfusion tube, wherein the inner perfusion tube is completely separated from the flexible core body or partially separated from the flexible core body by the reverse force generated by the outer tube, and the partially separated perfusion catheter is made of dissolved materials.

Furthermore, the device adopts real-time activation and delayed activation (i.e. not immediately activated when swallowing or inserting), the delayed activation mode comprises wake-up after preset time, activation through current and/or magnetic field so as to meet the requirement of detecting the distal gastrointestinal part outside the esophagus, and the corresponding collection mode is real-time or delayed.

Further, the data measured by the sensor can be subjected to fusion processing:

the calculation method of the mechanical and morphological fusion index GIP comprises the following steps:

GIP=A × CSA / P

wherein A is curvature, CSA is balloon cross-sectional area, and P is pressure;

The GIP is used for reflecting the functional relation among the curvature of the alimentary canal, the morphology of the cavity and the peristaltic force in the transportation process, and can be used for analyzing the correlation among the included angle His between the esophagus and the fundus, the morphology of the lower esophageal sphincter and the mechanical property;

The fusion index EGJIP calculating method comprises the following steps:

EGJIP=V × (P_r- P_f) / CSA / A,

Wherein V is the transport speed, P _r is the back end pressure, and P _f is the front end pressure;

EGJIP is used for reflecting the functional relation among the transportation speed of the content, the effective vermicular force, the cavity shape and the curvature in the transportation process.

Compared with the prior art, the invention has the following beneficial effects:

1. the upper digestive tract transport function detection device provided by the invention adopts a bionic structure design, is flexible and bendable equipment, and has the characteristics of being capable of swallowing and being easy to insert into esophagus. The device can detect various parameters in the digestive tract transportation process, wherein key parameters comprise axial pressure, acceleration and azimuth, various transmission indexes, forces and the like of specific time and position are further calculated through the key parameters, and examples of sensing technology which can be realized by the device comprise impedance measurement, pH recording, mucosa conductivity, video imaging, ultrasonic transducers, thermal resistors and the like.

2. The device can realize detection of different aspects of esophagus functions through a plurality of different detection embodiments. For example, the device can be used for detecting primary peristalsis of the oropharynx and the esophageal passageway when swallowed, can be inserted or swallowed into the esophagus through a thin wire or a catheter, can be retained in the esophagus for a short period of time, can be used for detecting secondary peristalsis by expanding an external balloon of the device during retention, and can be used for separating a connecting catheter immediately or after the balloon expansion is completed, so that the detection of transport characteristics based on the secondary peristalsis is realized. All tests can be performed in any position, such as lying, sitting or standing.

3. The data transmission mode of the invention adopts a wireless mode, so that the problem of parameter abnormality caused by discomfort of a subject due to an external pipeline is avoided. Meanwhile, the detachable perfusion tube scheme ensures that the device can effectively excite secondary peristalsis of the digestive tract, effectively makes up the functional defect of the existing swallowable capsule equipment, and achieves wireless bionic detection of the digestive tract transportation function in a real sense.

4. The invention provides two parameters for comprehensively evaluating the transportation characteristics of the digestive tract, and effectively realizes the fusion evaluation of mechanical, morphological and movement characteristic information.

5. The vast majority of the functions of the device are related to esophageal transport function detection and are therefore suitable for gastric and intestinal transport and movement detection.

Drawings

FIG. 1 is a schematic view of the device of example 1 of the present invention, wherein 90-cell, 95-membrane outer bladder, 101-flexible core, 102-bladder, 103-pressure sensor, 104-motion sensor, 105-microprocessor and wireless module, 106-valved irrigation channel, 107-impedance electrode.

FIG. 2 is a schematic view showing the structure of the device according to embodiment 2 of the present invention, wherein 108-first inflexible end portion, 109-second inflexible end portion, and 110-flexible middle portion.

FIG. 3 is a schematic view of the device of example 3 of the present invention, wherein 151-rigid head, 152-rigid middle, 153-rigid tail, 154-flexible tubing, 155-expandable sleeve.

Fig. 4 is a flow chart of the detection of the device of the present invention.

FIG. 5 is a schematic view showing an embodiment of the present invention for detecting the function of the upper gastrointestinal transit, wherein the probe is a 1-probe, a 2-esophagus, a 3-esophageal and fundus included angle (His angle), a 4-lower esophageal sphincter, and a 5-stomach.

FIG. 6 is a schematic representation of an embodiment of the present invention for detecting digestive tract transport function on a device wherein the 6-balloon embodiment probe (unexpanded), 7-detachable catheter, 8-balloon embodiment probe (expanded), 9-perfused fluid.

Fig. 7 is a schematic diagram of data transmission of the device of the present invention, wherein the 10-external wireless receiver.

FIG. 8 is a detachable embodiment of the infusion catheter of the present invention wherein 201-outer tube, 202-infusion inner tube, 213-inner tube force direction when detached, 214-outer tube force direction when detached.

Detailed Description

The invention is described in further detail below with reference to the drawings and the detailed description.

Referring to fig. 1 and 2, the invention provides an upper digestive tract transportation function detection device, which comprises a flexible core body 101 provided with a plurality of embedded sensors, wherein the plurality of embedded sensors comprise a pressure sensor 103, a motion sensor 104, a microprocessor and a wireless module 105, the pressure sensor 103 and the motion sensor 104 are arranged at two ends of the flexible core body 101, the microprocessor and the wireless module 105 are arranged at the middle part of the flexible core body 101, a battery is arranged between the two end sensors and the middle microprocessor and the wireless module 105, and a plurality of impedance electrodes 107 are distributed on the outer surface of the flexible core body 101.

The motion sensor comprises an accelerometer, a gyroscope and a magnetometer, and is used for calculating the direction, the curvature, the speed and the position of the device, thereby realizing high-precision evaluation of the transportation track of the device in the organ. And at least one motion sensor is used for transportation trajectory evaluation and at least two motion sensors are used for curvature measurement. In addition to the preferred embodiment, the device may be embedded with any other microsensor, such as impedance and conductivity tests, pH, cameras, ultrasonic resonators, thermal chokes, and chemical sensors, and this list of sensor technologies that can be implemented is not exclusive. The device has various sampling frequencies, the preferred implementation frequency in the esophagus is 50-100 Hz, and the implementation frequency at other parts can be lower or higher.

In addition, the two ends of the flexible core body 101 are hard non-bendable ends (108 and 109), the middle part is a bendable flexible middle part 110 made of a flexible material, and the two ends of the flexible core body 101 and the middle part are fixedly connected into a whole to form a columnar body with the same diameter. In the preferred embodiment, the flexible core 101 is made of medical flexible materials, wherein the medical flexible materials comprise pressure sensors distributed along the axial direction (the direction of a motion track), the motion sensors are arranged at two ends, and the hard inflexible ends (108, 109) are made of medical polymer materials.

The impedance electrode 107 on the flexible core 101 has different functions according to the embodiment of wrapping the balloon 102. In the embodiment with balloon 102 wrapped, impedance electrode 107 is used for impedance cross-sectional area measurement of the balloon, and in the embodiment without balloon 102 wrapped, impedance electrode 107 is used for digestive tract impedance measurement.

The device of the present invention is made of materials safe to the human body, and needs to have a strong acid resistant design to ensure that gastric acid does not contact the materials inside the device in the strong acid environment of the stomach, and the flexible core 101 is covered with acid resistant materials (i.e., loose or tight film outer capsule 95).

Referring to fig. 3, the flexible core 101 is formed by interconnecting a plurality of short rigid parts (151, 152, 153), the parts are connected by a thinner flexible pipeline 154, the outer wall of the pipeline is covered by an expandable sleeve 155, the expandable sleeve can be expanded to have the same diameter as the rigid parts by pouring liquid or gel into the sleeve, and a plurality of different bolus characteristics can be simulated according to the mechanical properties of the poured liquid or gel.

Referring to fig. 4, using the device of the present invention, if it is desired to detect a distal gastrointestinal site outside the esophagus, it may be activated with a delay, i.e., not immediately upon swallowing or insertion. This way can be set according to the region of interest. Such as the small intestine, it is most reasonable to begin information collection 2-3 hours after it has passed through the stomach. The activation mode can be different modes, including wake-up after a preset time, activation through current and magnetic field.

In a preferred embodiment, the data is collected in real time and displayed on an electronic device such as a computer, notebook, tablet or smart phone, and analysis and/or clinical diagnosis of various important parameters can be performed, the analysis type and diagnosis including front-to-back pressure differences, gravitational field angle, speed and position as a function of time, device bending, pressure-acceleration relationship, force and stress calculations, preload-afterload load maps of pressure and/or cavity diameter measurements, transmission parameters, speed and pressure and acceleration endpoints, and the like (the list is not comprehensive).

The data measured by the device may be processed in a variety of ways depending on the number and variety of sensors included in the device. This involves simple direct recording (e.g., pressure change over time after swallowing or insertion into the esophagus) to a variety of complex algorithms. Among them, patients with gastroesophageal reflux disease (GERD) have weaker lower esophageal sphincter and gastroesophageal junction (EGJ) may be straight (angle of His smaller) than normal. Thus, the device has a smaller measured tortuosity A, a larger lumen diameter CSA and a lower pressure P when passing through the lower esophagus and EGJ. This may be integrated as a more advanced index algorithm, GERD Index (GIP), gip=a×csa/P.

The processing mode further comprises index parameters obtained based on analysis and numerical simulation. And data analysis is carried out on gastroesophageal junction diseases such as esophageal and gastric outflow obstruction (EGJOO), achalasia and the like by other algorithms, so that indexes are provided for clinical diagnosis. In EGJOO, the pressure at the front end of the device is generally high, the acceleration and speed at the lower position of the esophagus are reduced, and the diameter is reduced. In addition, if the esophagus expands, the device may remain in the lower portion of the esophagus. When this occurs, the orientation of the device itself may be offset from the axial direction, and in the radial direction. This feature can be obtained by plotting simple raw parameters as a color profile. All the parameters mentioned above can also be analyzed in the color profile, including EGJIP index=v× (P _r- P_f)/CSA/a. Other analyses may also include esophageal wall friction (transport resistance) based on equilibrium equations for transport forces, and the like.

The data measured by the sensor can be subjected to fusion processing:

GIP=A × CSA / P

wherein A is curvature, CSA is balloon cross-sectional area, and P is pressure;

The fusion index EGJIP calculating method comprises the following steps:

EGJIP=V × (P_r- P_f) / CSA / A,

Further, referring to fig. 1, the device of the present invention may further comprise an expandable balloon 102 wrapped outside the flexible core 101, and a pouring channel 106 with a valve is provided inside the flexible core 101.

Referring to fig. 5, an embodiment of the device for detecting the function of upper gastrointestinal transport according to the invention is shown, wherein the device 1 is arranged to enter the esophagus through the esophagus 2, enter the included angle (His angle) 3 between the esophagus and the fundus, and then enter the lower esophageal sphincter 4 and the stomach 5, and the device can acquire relevant information during the movement process. The device is swallowable or inserted through the mouth, is flexible, soft or comprises one or more soft parts, preferably 4-6 cm long and 6-8mm in diameter, but may be larger or smaller than other swallowable devices for registering gastrointestinal movements and pH values. Experiments have shown that soft flexible objects (e.g. soft gums) with a length of 6-7cm and a diameter of 6-8mm are easy to swallow without serious discomfort. The residence time and the discharge mode of the device in the body are the same as those of the common functional capsule equipment. After swallowing or insertion through the mouth, the entire digestive tract is followed by anal discharge for about 19-36 hours.

Referring to fig. 6, an embodiment of the present invention for detecting the function of the upper gastrointestinal tract transport is shown, in some embodiments of the device that may be expandable or may perform the function of impedance mapping, the surface of the device may be balloon wrapped, in other embodiments, balloon wrapping may not be required. The perfusion channel for connecting the balloon and the catheter of the device comprises a valve to avoid the escape of the liquid in the balloon, wherein the balloon is expanded by the balloon (unexpanded) 6 of the device through the detachable catheter 7, the balloon (expanded) 8 caused by the perfusion liquid 9 has the effect of stimulating the secondary peristaltic action of the digestive tract, and the detachable catheter 7 can be automatically disconnected.

Referring to fig. 7, a detachable embodiment of the infusion catheter of the present invention is shown, and in some embodiments, particularly balloon-wrapped embodiments, the device has a catheter connection, the catheter may be used for fluid infusion to dilate the balloon, either before swallowing or after swallowing or insertion into the target site. In a preferred embodiment, the catheter may be removed by simple mechanisms (including counter force, magnetic force, pre-clamping, etc.), such as by using an outer tube to create a counter force to separate the catheter from the device, or the catheter and portion of the catheter may remain attached to the device, and the tube in such embodiments may be made of a self-dissolvable material, such as dissolution occurs after 10 minutes, wherein the outer tube 201, the infusion inner tube 202, the inner tube force direction 213 when removed, and the outer tube force direction 214 when removed.

In addition, the device system necessarily includes an external wireless receiver (except for embodiments with memory chips where the device data is collected after ejection), which may take a variety of forms and shapes, which in preferred embodiments is portable and may be placed at various locations, such as on the abdominal skin proximate to the stomach, on the abdominal skin of the intestines, etc., depending on the amount of received power, which in preferred embodiments is wireless and includes one or more batteries, which may be rechargeable to provide longer run times.

The detection process comprises the steps of firstly activating the device, starting data acquisition of the sensor, swallowing or inserting the device into the esophagus, assisting in positioning the device at a detection actual position through a thin wire or a perfusion catheter, carrying out saccule perfusion, separating the perfusion catheter, enabling the device to enter the stomach from the esophagus, and transmitting the data to an external wireless receiver in a wireless way.

The implementation mode of the detection process is not unique, and the detection process and the mode can be selected according to the functional structure, different activation modes and data transmission modes of the device and the detection purpose.

Referring to fig. 8, there is a schematic diagram of data transmission of the device of the present invention, wherein 10 is an external wireless receiver. In preferred embodiments, the data is transmitted wirelessly from the stomach or other parts of the gastrointestinal tract, including in real time or delayed transmission, and in other embodiments, the data may be stored on a memory chip and data extracted after the device is removed from the body.

The invention adopts a bionic structure design, has the characteristics of swallowing and easy insertion into esophagus, can detect key parameters including axial pressure, acceleration, azimuth and the like, further calculates various transmission indexes, forces and the like of specific time and position through the key parameters, solves the problem of functional detection on the bending property, the transportation acceleration, the speed, the track and the like of the esophagus, and acquires the information and the relevant characteristics of the esophageal pressure and symptoms so as to meet the functional requirements of organic lesions and perception function diagnosis.

Finally, it should be noted that the above embodiments are only for illustrating the technical solution of the present invention and not for limiting the technical solution, and those skilled in the art should understand that modifications and equivalents may be made to the technical solution of the present invention without departing from the spirit and scope of the present invention, and all such modifications and equivalents are included in the scope of the claims.

Claims

1. A device for detecting upper gastrointestinal transport function, characterized in that it comprises a flexible core on which functional devices are provided; 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, _Pr is the back-end pressure, and _Pf is the 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 parts with a compact, non-bendable part containing functional components to form a columnar body with the same diameter.

3. The upper digestive tract transport function testing device according to claim 1, characterized in that the flexible core is further provided with a valved infusion channel, and the valved infusion channel is connected to a detachable infusion 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 gastrointestinal transport function detection device according to claim 1, characterized in that it adopts real-time activation and delayed activation; the delayed activation method includes waking up after a preset time and activation by current and/or magnetic field, so as to meet the needs of detecting the distal gastrointestinal tract outside the esophagus; the corresponding collection method is either real-time or delayed mode.

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