Balloon catheter gastrointestinal electrical assembly with three-dimensional raised electrodes

Abstract

The utility model discloses a balloon catheter gastrointestinal electrical assembly with a three-dimensional raised electrode. A cage-shaped electrode sleeves a balloon part of the balloon catheter, the cage-shaped electrode comprises a plurality of flexible microelectrode strips, the flexible microelectrode strips are uniformly arranged outside the balloon part at intervals in an array manner in the circumferential direction of the balloon part, and the catheter parts at the two ends of the balloon part are sleeved with the two ends of each flexible microelectrode strip respectively; each flexible microelectrode strip is provided with an electrode site, and each electrode site is arranged to be of a three-dimensional protruding structure to form a three-dimensional protruding electrode. The three-dimensional convex electrode can break through the barrier of a mucosa layer under the expansion action of the balloon, so that the electrode is more effectively contacted with the muscle layer of the gastrointestinal tract, the barrier action of the mucosa layer of the gastrointestinal tract is overcome, the accuracy of the interventional gastrointestinal tract electrophysiological test tool can be improved, more accurate electrophysiological analysis is realized, and the test efficiency is improved. Wide application prospects are realized.

Description

Technical Field

[0001] The utility model relates to the field of medical devices, in particular to a balloon catheter gastrointestinal electrical component, an electrophysiological sensor with enhanced three-dimensional convex electrode structure and its application. Background Art

[0002] The core function of the gastrointestinal tract is to digest food and absorb nutrients to maintain the normal functions of the body and energy supply. Bioelectric activities regulate the rhythmic contractions of the gastrointestinal tract by coordinating peristalsis and secretion functions, thus ensuring the effective digestion and movement of food and maintaining the smooth operation of the digestive system and the full absorption of nutrients. At present, the development of gastrointestinal electrophysiology has evolved from early research to advanced diagnostic tools, showing the potential for transformation. For example, intestinal electrophysiological methods with the significance of being used as diagnostic tools include wearable surface gastric electrical devices, high-resolution electrode arrays used through laparotomy or laparoscopic surgery, balloon-type gastric electrical electrodes intervened through the oral cavity, and ingestible electrophysiological data acquisition capsules. These technologies all have considerable advantages. For example, the wearable surface gastric electrical device has the non-invasive feature and has been used to examine functional gastric diseases such as chronic nausea and vomiting syndrome. By laying the high-resolution electrode array on the surface of the small intestinal serosa layer, the bioelectric slow wave activities and their spatio-temporal propagation characteristics of the human jejunum have been recorded, and many irregular electrophysiological patterns have been discovered. By combining the balloon electrode with an endoscope and an ablation tool, after depicting the electrogram mapping and finding the target position of the gastric antrum, ablation can be performed to assist in the diagnosis and treatment of functional gastrointestinal diseases such as gastroparesis. The capsule-type electrophysiological system designs a sensing electrode band that can be deployed in the stomach, which can directly contact the mucosa and record and wirelessly transmit bioelectric signals such as gastric slow waves, respiration, and cardiac signals.

[0003] However, the barrier of the mucosal layer is still the main obstacle to the non-invasive and refined recording of gastrointestinal electrophysiological activities. The main reasons include: First, the thickness and physical properties of the mucosal layer of the gastrointestinal tract will have a significant attenuation effect on the conduction of electrical signals, making the intensity of the electrical signals detected on the mucosal surface insufficient for accurate electrophysiological analysis. Second, the mucosal layer and the muscular layer tissues below it are complex and variable, and their electrophysiological activities will interfere with each other, making it difficult to obtain clear and independent electrophysiological signals. Finally, long-term and stable detection of electrophysiological signals on the mucosal layer requires a stable contact interface between the sensor and the mucosal layer. However, due to the slippery and dynamic characteristics of the mucosal layer, it is extremely difficult to maintain this stable contact. Therefore, overcoming these challenges is the key to the effective development of non-invasive gastrointestinal electrophysiological tests.

[0004] In the prior art, due to the limitation of using planar electrodes, the physiological information that can be interpreted from the collected electrophysiological signals is limited. Summary of the Utility Model

[0005] In view of the problems existing in the background technology, that is, the existing planar electrodes are prone to losing signal details during electrophysiological acquisition on the body surface or the intestinal mucosa side, and invasive tests will bring infection risks and other problems, in the present utility model, there is a balloon catheter gastrointestinal electrocomponent with three-dimensional raised electrodes.

[0006] The solution of the present utility model includes:

[0007] It includes a balloon catheter, which includes a catheter part and a balloon part located at the distal rod of the catheter part;

[0008] It includes a cage-shaped electrode, which is sleeved outside the balloon part of the balloon catheter. The cage-shaped electrode is mainly composed of multiple strip-shaped flexible microelectrode strips. Each flexible microelectrode strip is arranged at equal intervals in an array around the circumference of the balloon part of the balloon catheter outside the balloon part. The two ends of each flexible microelectrode strip are respectively sleeved on the catheter parts at both ends of the balloon part of the balloon catheter; at least one electrode site is arranged on each flexible microelectrode strip;

[0009] It includes a three-dimensional raised structure, which is arranged at each electrode site. Each electrode site is set as a three-dimensional raised structure to form a three-dimensional raised electrode.

[0010] A movable mounting ring is sleeved on the catheter parts at both ends of the balloon part of the balloon catheter. The two ends of each flexible microelectrode strip are respectively fixed to the mounting rings at both ends.

[0011] It also includes an electrode at the proximal rod. The electrode at the proximal rod is located at the proximal end of the catheter part of the balloon catheter. The electrode at the proximal rod and the cage-shaped electrode are connected by a wire.

[0012] The balloon catheter has a first state and a second state. The balloon part of the balloon catheter is not inflated in the first state, and the balloon part of the balloon catheter becomes an inflated balloon shape in the second state; the cage-shaped electrode has a first state and a second state. In the first state, each flexible microelectrode strip of the cage-shaped electrode remains in a strip shape consistent with the catheter part of the balloon catheter. In the second state, each flexible microelectrode strip of the cage-shaped electrode is deformed into an arc shape covering the surface of the balloon under the expansion action of the balloon catheter.

[0013] After the balloon part of the balloon catheter extends into the gastrointestinal tract, the three-dimensional raised structure of each electrode site is squeezed into the mucosal layer of the gastrointestinal tract in the second state of the balloon catheter and the cage-shaped electrode.

[0014] The three-dimensional raised structure is a non-sharp semi-spherical structure, with a height of 0.1 - 800 μm.

[0015] Applications in electrophysiological acquisition and three-dimensional mapping of the gastrointestinal tract.

[0016] The utility model is provided with a cage-shaped flexible stent on the surface of an inflatable balloon, and microelectrodes with a three-dimensional convex structure are arranged on the stent. Another electrode is arranged on the distal rod connected to the cage-shaped object, and this electrode is connected to a collection circuit such as an amplification circuit. After being inserted through the natural body cavity of a human body, the three-dimensional convex electrodes can break through the barrier of the mucosal layer under the action of the inflation of the balloon, enabling the electrodes to establish more effective contact with the muscular layer of the gastrointestinal tract, thereby realizing more accurate electrophysiological analysis.

[0017] In the solution of the utility model, it is innovatively proposed that not only are the cut flexible electrode arrays integrated and assembled with the balloon catheter, but also a non-sharp three-dimensional convex structure is arranged on the surface of the electrodes to overcome the barrier effect of the gastrointestinal mucosal layer, enabling the electrodes to have more stable contact with the gastrointestinal tissue, improving the accuracy of the invasive gastrointestinal electrophysiological test tool, and having broad application prospects.

[0018] The beneficial effects of the utility model are as follows:

[0019] The advantages of the utility model lie in that its manufacturing process has very excellent repeatability and the consistency of the electrode array structure, and the electrode array with a three-dimensional structure can not only test the burst activities of smooth muscles but also test the periodic pacing activities of the gastrointestinal tract.

[0020] In summary, the disclosed content of the utility model innovatively proposes an electrophysiological mapping technology that can be minimally invasively inserted, break through the barrier of the mucosal layer, and has high spatio-temporal resolution ability, for stably recording the complex electrophysiological signals of the gastrointestinal tract. As a diagnostic tool, it is expected to provide a new strategic method for the non-invasive and precise diagnosis of functional gastrointestinal diseases. Description of the Drawings

[0021] The embodiments are shown and explained with reference to the attached drawings. These drawings are used to clarify the basic principles and thus only show the aspects necessary for understanding the basic principles. These drawings are not to scale. In the drawings, the same reference numerals represent similar features.

[0022] Figure 1 is the overall structure diagram of the utility model;

[0023] Figure 2 is the structure diagram of the balloon catheter of the utility model;

[0024] Figure 3 is the schematic diagram of the preparation process of the cage-shaped electrode and its assembly process with the balloon catheter;

[0025] Figure 4 is the schematic diagram of the layout of personnel and equipment when the gastrointestinal electro-component is applied;

[0026] Figure 5It is a schematic diagram of the contact characteristics of the balloon and the cage electrode with the canal tissue in the second state;

[0027] Figure 6 It is a schematic diagram that when the balloon maintains the second state, the three-dimensional raised electrode can break through the barrier of the mucosal layer, thereby enhancing the contact between the electrode and the muscular layer and intestinal nerves;

[0028] Figure 7 It is a physical diagram of the balloon catheter with three-dimensional raised electrodes when maintaining the second state;

[0029] Figure 8 It is the multiphase intestinal signals recorded by the three-dimensional raised electrode, including not only bursty myoelectric activity but also periodic pacing activity;

[0030] Figure 9 It is a physical diagram of the balloon catheter with planar electrodes when maintaining the second state;

[0031] Figure 10 It is the single-phase intestinal signal recorded by the planar electrode, showing bursty myoelectric activity.

[0032] In the figure: three-dimensional raised structure 11, cage electrode 12, balloon catheter 13, electrode at the proximal rod 14.

[0033] Other features, characteristics, advantages and benefits of the present disclosure will become more apparent through the following detailed description in conjunction with the accompanying drawings. Detailed implementation manners

[0034] In order to make the objectives, technical solutions and advantages of the present application clearer, the present application will be further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and are not used to limit the present application.

[0035] Electrophysiological recording technology is a technology used to measure and record electrical activities in living organisms. By capturing the electrical activities of the gastrointestinal tract, electrophysiological recording technology can provide a key means to understand its normal functions and pathological states, and has important application values for the diagnosis and treatment of gastrointestinal diseases.

[0036] Testing gastrointestinal electrophysiological signals through an invasive method (transoral or transanal) is a promising non-invasive method, but it also faces multiple challenges. These include: (1) The operation technique is complex and requires a high level of fine operation to ensure accurate electrode placement and avoid tissue damage; (2) Signal interference problems. Due to the complex movements and other physiological activities of the gastrointestinal tract, the recorded electrical signals may be interfered by motion artifacts and noise, thus affecting the accuracy and interpretation of the data; (3) Difficulty in long-term stable and high-quality data recording. The electrode position may shift during long-term recording, resulting in signal loss or data distortion, and continuous monitoring and adjustment are required.

[0037] To perform effective invasive electrophysiological recording in the gastrointestinal environment, the expansion effect of the balloon catheter is used in this disclosure to keep the electrode array of the cage structure stable at the tissue interface. The purpose of this design is that when the balloon catheter is in the contracted state, the entire electrode array is flexible and can be contracted into a smaller space, making it easy to extend to the target position. After positioning, it can be switched to the second state, that is, the balloon inflation state. Since the gastrointestinal environment is mostly tubular, the cage-shaped electrodes can make stable contact with the gastrointestinal wall after inflation, which can ensure the effectiveness of electrophysiological recording. In addition, after the balloon is inflated, the contrast is obvious under X-ray, making it easy for the physician to observe its fitting condition with the target tissue and further ensuring the fitting effect. Further, due to the air duct connectivity at the head and tail of the balloon catheter, the ventilation and exhaust of the gastrointestinal tissue will not be affected in the balloon inflation state.

[0038] In addition to applying the balloon and electrode array that can be switched between the first and second states, this disclosure also innovatively proposes not only using the expansion effect of the balloon to make the electrode contact the tissue wall, but also preparing a three-dimensional raised structure at the electrode, enabling the electrode to break through the barrier of the mucosal layer and contact the deep tissue, so that the electrophysiological system can collect more refined electrophysiological signals.

[0039] Specifically, the following will be combined with the attached Figures 1 to 10 to describe the structure of the balloon catheter with a three-dimensional structure according to this disclosure, as well as the corresponding manufacturing and use methods.

[0040] As Figure 1As shown in the figure, the gastrointestinal electro-component of the balloon catheter includes a three-dimensional convex structure 11, a cage electrode 12, and a balloon catheter 13; the balloon catheter 13 includes a catheter portion and a balloon portion located at the distal rod of the catheter portion. The proximal end of the catheter portion is ventilated or evacuated, so as to inflate or deflate the balloon portion. A cage electrode 12 is sleeved outside the balloon portion of the balloon catheter 13. The cage electrode 12 is mainly composed of multiple strip-shaped flexible microelectrode strips. Each flexible microelectrode strip is arranged in a uniformly spaced array around the circumference of the balloon portion of the balloon catheter 13 outside the balloon portion. Both ends of each flexible microelectrode strip are respectively sleeved on the catheter portions at both ends of the balloon portion of the balloon catheter 13; at least one electrode site is provided on each flexible microelectrode strip, and each electrode site is set as the three-dimensional convex structure 11, so that each electrode site constitutes a three-dimensional convex electrode.

[0041] Mounting rings that can move axially along the catheter portion are sleeved on the catheter portions at both ends of the balloon portion of the balloon catheter 13. Both ends of each flexible microelectrode strip are respectively fixed to the mounting rings at both ends. In this way, the cage electrode 12 formed by each flexible microelectrode strip can be integrally wrapped outside the balloon portion, and can also move axially along the catheter portion, and then perform the same movement and deformation after the balloon portion expands, maintaining a complete wrap of the balloon portion.

[0042] In a specific implementation, one electrode site can be provided on each flexible microelectrode strip, and the electrode sites of each flexible microelectrode strip are all located in the same circumferential direction.

[0043] In a specific implementation, multiple groups of electrode sites can be set. Each group of electrode sites is composed of one electrode site provided on each flexible microelectrode strip. The electrode sites in the same group are all located in the same circumferential direction, and the electrode sites in different groups are located in different circumferential directions.

[0044] Figure 2 Schematically shows the distribution method of the three-dimensional convex electrodes on the distal cage structure. Figure 2 As can be seen, the 30 electrodes shown are uniformly arranged on the balloon surface in a 15×2 manner. Here, those skilled in the art should understand that the electrodes can have more numbers and distribution methods, and only need to be designed according to the tested tissue position and requirements and manufactured according to the method.

[0045] It also includes an electrode 14 at the proximal rod. The electrode 14 at the proximal rod is located at the proximal end of the catheter portion of the balloon catheter 13. The electrode 14 at the proximal rod and the cage electrode 12 are electrically connected by a wire, and the wire is pasted and fixed on the outer wall of the balloon catheter 13.

[0046] In a specific implementation, the electrode sites of each flexible microelectrode strip in the cage electrode 12 and the electrode 14 at the proximal rod are electrically connected by a wire.

[0047] The balloon catheter 13 has a first state and a second state. The balloon portion of the balloon catheter 13 is not inflated in the first state, and the balloon portion of the balloon catheter 13 assumes an inflated balloon shape in the second state.

[0048] The cage-shaped electrode 12 has a first state and a second state. In the first state, each flexible microelectrode strip of the cage-shaped electrode 12 maintains a strip shape consistent with the catheter portion of the balloon catheter 13. In the second state, each flexible microelectrode strip of the cage-shaped electrode 12 is deformed into an arc shape covering the surface of the balloon under the expansion action of the balloon catheter.

[0049] As Figure 1 shown, the balloon catheter with three-dimensional raised electrodes includes a balloon catheter 13 that can be in a first state (contracted) or a second state (inflated), a cage-shaped electrode 12 that can be in a first state (relaxed) or a second state (tensed), a three-dimensional raised structure 11 located on the electrode surface, and an electrode at the proximal rod for connecting to an electrophysiological testing system 14. Figure 1 Only the second state of the balloon catheter with three-dimensional raised electrodes is shown.

[0050] After the balloon portion of the balloon catheter 13 extends into the gastrointestinal tract, the three-dimensional raised structure 11 at each electrode site is squeezed deep into the mucosal layer of the gastrointestinal tract under the expansion action of the balloon catheter 13 and the cage-shaped electrode 12 in the second state, i.e., when the balloon is inflated.

[0051] The electrode 14 at the proximal rod is electrically connected to an external electrophysiological testing system.

[0052] In a specific implementation, the main body of the flexible microelectrode strip is composed of two layers of polymer materials. A wiring electrode is provided between the two layers of polymer materials. Each wiring electrode is wrapped between the two layers of polymer materials, and only the electrode site of the wiring electrode is exposed.

[0053] The three-dimensional raised structure 11 is a non-sharp semi-spherical structure with a height of 0.1 - 800 μm.

[0054] The electrode metal includes gold, and the three-dimensional raised structure 11 is made of materials including tin, silver, gold, or platinum.

[0055] The preparation process of the balloon catheter gastrointestinal electro-component of the present utility model includes the following:

[0056] (1) Preparation of the flexible circuit:

[0057] Design an electrode array pattern composed of each flexible microelectrode strip and prepare a flexible printed circuit using a standard planar lithography process. The circuit is made of gold or copper plated with gold. The electrode sites at the distal end of the circuit are exposed, and the wiring electrodes are wrapped in multiple layers of thin films.

[0058] (2) Cutting of the flexible circuit:

[0059] The electrode array pattern is cut into a grid shape by a laser cutting or pattern cutting method to form each flexible microelectrode strip;

[0060] (3) Preparation of the three-dimensional convex structure:

[0061] It is fixedly positioned and welded to the electrode site by using solder of a fixed size to form a convex electrode, and then silver, gold, or platinum metal is magnetron sputtered at the convex electrode, or silver, gold, or platinum is directly electroplated at the convex electrode by using a template to prepare and form the three-dimensional convex structure 11.

[0062] (4) Assembly of the flexible circuit and the balloon catheter:

[0063] Keep the balloon catheter in the expanded second state, with the three-dimensional convex structure 11 facing outwards. Each cut flexible microelectrode strip is sleeved and integrated with the catheter part through a metal mounting ring, and the tail wire is wound to the proximal end of the catheter part, so that the electrode 14 at the proximal rod is arranged at the proximal rod and connected to the electrophysiological acquisition system.

[0064] In one embodiment, it relates to the processing and manufacturing process of a balloon catheter with a three-dimensional convex structure, which consists of Figure 3 It can be seen that the core of the electrode array design is to ensure that it can adapt to balloon catheters of different sizes after cutting. Ensure that after assembly, the electrodes are evenly distributed along the equatorial axis of the balloon and do not overlap.

[0065] Application in electrophysiological acquisition and three-dimensional mapping of the gastrointestinal tract. The balloon catheter gastrointestinal electro-component can be introduced through the natural cavity for electrophysiological acquisition and three-dimensional mapping of the gastrointestinal tract.

[0066] The balloon catheter gastrointestinal electro-component of the present utility model is introduced into the gastrointestinal tract through the oral cavity or anus. After positioning, the catheter part of the balloon catheter is inflated to make the balloon part expand to form the second state, and the cage-shaped electrode 12 is also driven to expand to form the second state. Under the combined action of the expansion and the three-dimensional convex structure 11, the electrode sites of each flexible microelectrode strip in the cage-shaped electrode 12 are stably contacted with the tissue structure behind the gastrointestinal mucosa. The electrode sites of each flexible microelectrode strip of the cage-shaped electrode 12 are connected to a multi-channel electrophysiological test system to transmit the collected electrical signals to the multi-channel electrophysiological test system, realizing multi-channel recording of the electrophysiological activities of the gastrointestinal tract.

[0067] The electrophysiological activities of the gastrointestinal tract include periodic pacing activities and explosive activities of smooth muscle.

[0068] The specific implementation in the solution further includes a grounding electrode, which is arranged in the electrode array, or is separately in contact with the gastrointestinal tissue and remains connected to the acquisition device.

[0069] In one embodiment, two layers of polyimide films with a thickness of about 20 μm are used to provide insulation and support for coating a copper / gold layer with a thickness of about 5 μm. The electrode has a diameter of 500 μm and the wire width is 50 μm. The patterns of the electrodes and wires are defined by a standard photolithography process, and the excess metal layer is etched away. The electrode array consists of 2×15 electrode sites; before assembly, the circumferential spacing between adjacent electrode sites is 1 mm, and the longitudinal spacing is 3.5 mm. The electrode array is cut into a grid with a spacing of 1 mm by laser cutting.

[0070] In order to fabricate a non-sharp three-dimensional raised structure on the planar electrode surface, in one embodiment, a solder with a diameter of 450 μm is welded onto the electrode surface to form a hemispherical electrode, and then a gold film is sputtered onto the solder to ensure the biocompatibility of the device. Here, those skilled in the art should understand that the three-dimensional raised electrodes can be fabricated by various process methods, such as electroplating, template deposition method, etc., and only need to be designed and fabricated according to the requirements of the thickness of the mucosal layer in the test part.

[0071] In one embodiment, a method of using a balloon catheter with a three-dimensional raised structure is also disclosed. Figure 4 It can be seen that under the action of the lubricant, the unconstrained cage-shaped electrode can be inserted into the intestine through the anus. In order to avoid excessive inflation of the balloon, it can be controlled by controlling the amount of air pushed into the balloon. After the electrode is positioned and inflated, multi-channel electrogastrogram recording can be performed using an electrophysiological test system at the bedside and a host computer. Here, those skilled in the art should understand that the balloon electrode can not only be inserted into the intestine through the anus, but also be inserted into the stomach through the mouth. By changing the distribution mode of the electrodes and the endoscopic positioning method, electrophysiological tests for irregular regions such as the gastric antrum can be realized. More specifically, the contact characteristics between the inflated balloon and the intestinal wall are as Figure 5 shown. Obviously, the influence of intestinal peristaltic movement on the acquisition process can be effectively reduced through the inflation of the balloon. Further, as Figure 6 shown, by designing a non-sharp raised structure at the electrode tip, the electrode can effectively break through the mucosal layer, promote its contact with the smooth muscle layer, intestinal pacemaker cells or nerve plexus, and help collect more gastrointestinal electrophysiological information.

[0072] In one embodiment, the use effect of a balloon catheter with a three-dimensional raised structure is also disclosed. As Figure 7 shown, it is a micrograph of the physical object of a balloon catheter with a three-dimensional raised structure. It can be seen that the electrodes are evenly distributed on the spherical surface in a 2×15 array manner after the balloon is inflated. In order to verify the effectiveness and excellent characteristics of the instrument test, the balloon catheter with a three-dimensional raised structure is inserted into the intestine through the anus in an experimental rabbit model. As Figure 8As shown, it not only records the bursting activity of smooth muscle, but also effectively records the periodic pacing activity of the intestine. Compared with the publicly disclosed invasive gastrointestinal electrophysiological testing devices, it shows unexpected testing effects.

[0073] In a comparative example, the use effect of a balloon catheter without a three-dimensional convex structure (i.e., using planar electrodes) is also disclosed. As Figure 9 shown, it is a physical microscopic photograph of a balloon catheter without a three-dimensional convex structure. It can be seen that the electrodes are evenly distributed on the spherical surface in a 2×15 array manner after the balloon is inflated. After the balloon catheter with a three-dimensional convex structure is inserted into the intestine of an experimental rabbit model through the anus, as Figure 10 shown, only the bursting activity of smooth muscle is recorded, and more signals such as periodic pacing activity cannot be recorded.

[0074] From the comparison of the examples and the comparative examples, it can be seen that each electrode channel can effectively test electrophysiological signals after the balloon electrode is inserted, showing a very high recording success rate. This indicates that a stable electrode-tissue interface can be established by using the balloon inflation effect. Here, those skilled in the art should understand that by appropriately designing the three-dimensional arrangement of the electrodes, it is possible to achieve the recording of the signal propagation characteristics of the transverse and longitudinal muscle layers of the gastrointestinal tract, as well as the recording of the three-dimensional spatio-temporal electrical propagation in irregular tissue regions.

Claims

1. A balloon catheter gastrointestinal electrical component with three-dimensional raised electrodes, characterized in that it includes a balloon catheter (13), which includes a catheter portion and a balloon portion located at the distal rod of the catheter portion; it includes a cage electrode (12), which is sleeved outside the balloon portion of the balloon catheter (13). The cage electrode (12) is mainly composed of multiple flexible microelectrode strips. Each flexible microelectrode strip is arranged in a uniformly spaced array outside the balloon portion of the balloon catheter (13) along the circumferential direction of the balloon portion. The two ends of each flexible microelectrode strip are respectively sleeved on the catheter portions at both ends of the balloon portion of the balloon catheter (13); at least one electrode site is provided on each flexible microelectrode strip; it includes a three-dimensional raised structure (11), which is provided at each electrode site. Each electrode site is set as the three-dimensional raised structure (11) to form a three-dimensional raised electrode.

2. The balloon catheter gastrointestinal electrical component with three-dimensional raised electrodes according to claim 1, characterized in that, A movable mounting ring is sleeved on the catheter portions at both ends of the balloon portion of the said balloon catheter (13). The two ends of each flexible microelectrode strip are respectively fixed to the mounting rings at both ends.

3. The balloon catheter gastrointestinal electrical component with three-dimensional raised electrodes according to claim 1, wherein, It further includes a proximal rod electrode (14). The proximal rod electrode (14) is located at the proximal end of the catheter portion of the balloon catheter (13). The proximal rod electrode (14) and the cage electrode (12) are connected by a wire.

4. The balloon catheter gastrointestinal electrical component with three-dimensional raised electrodes according to claim 1, characterized in that The said balloon catheter (13) has a first state and a second state. The balloon portion of the balloon catheter (13) is not inflated in the first state, and the balloon portion of the balloon catheter (13) becomes an inflated balloon shape in the second state.

5. A balloon catheter gastrointestinal electrical component having a three-dimensional raised electrode according to claim 1, characterized in that, The said cage electrode (12) has a first state and a second state. In the first state, each flexible microelectrode strip of the cage electrode (12) remains in a strip shape consistent with the catheter portion of the balloon catheter (13). In the second state, each flexible microelectrode strip of the cage electrode (12) is deformed into an arc shape covering the balloon surface under the inflation action of the balloon catheter.

6. The balloon catheter gastrointestinal electrical component with three-dimensional raised electrodes according to claim 1, characterized in that, After the balloon portion of the balloon catheter (13) extends into the gastrointestinal tract, the three-dimensional raised structure (11) of each said electrode site is squeezed into the mucosal layer of the gastrointestinal tract in the second state of the balloon catheter (13) and the cage electrode (12).

7. The balloon catheter gastrointestinal electrical component with three-dimensional raised electrodes according to claim 1, characterized in that, The said three-dimensional raised structure (11) is a semi-spherical non-sharp structure, with a height of 0.1 - 800 μm.

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