Electric field ablation device for digestive tract, ablation system and application

Abstract

The invention relates to an electric field ablation device and ablation system for the digestive tract and application, the electric field ablation device comprises a first rod, a second rod, a supporting piece and an electrode assembly, the second rod is slidably arranged on the first rod in a sleeving mode, and the first far end portion of the first rod is exposed; the supporting piece is fixedly connected between the first far-end portion and the second far-end portion of the second rod, a plurality of electrodes on the electrode assembly are arranged on the supporting piece, the supporting piece can be switched between the expansion state and the contraction state by driving the first rod and the second rod to slide relatively, the structure is simple, and operation is convenient. When the supporting piece is in the expanded state, the electrode is exposed out of the surface, away from the first rod, of the supporting piece and can be tightly attached to the tissue of the digestive tract, and therefore accurate ablation treatment can be achieved for treating diabetes or obesity.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to an electric field ablation device for the digestive tract, as well as an ablation system and use of the electric field ablation device. Background Art

[0002] Diabetes is a chronic metabolic disease, mainly manifested as an abnormal increase in blood glucose levels. Its core mechanism is insufficient insulin secretion or insulin action disorder, resulting in glucose being unable to effectively enter cells for energy supply and thus accumulating in the blood. According to the etiology and pathological characteristics, diabetes is mainly divided into the following categories: Type I diabetes: mostly caused by autoimmune destruction of pancreatic islet β cells leading to absolute insulin deficiency, commonly seen in children and adolescents; Type II diabetes: mainly due to insulin resistance and relative insulin deficiency, mostly related to obesity and lifestyle, accounting for the majority of diabetic patients.

[0003] Currently, Type II diabetes is treated surgically. Traditional surgeries are usually gastric bypass surgery or sleeve gastrectomy. The diabetes remission rate is as high as 60%-80% one year after surgery, and the recurrence rate is less than 20% after 5 years. It is especially suitable for severely obese (BMI≥35 kg / m 2 ) patients, but it requires general anesthesia and laparoscopic / open abdominal surgery. Postoperatively, anastomotic leakage, malnutrition (such as iron / calcium deficiency), dumping syndrome, etc. may occur, and the recovery time is long, the anatomical structure changes permanently (such as a reduction in gastric volume), the original physiological state cannot be restored after surgery, and the difficulty of secondary surgery is high. In the prior art, there are also means of intervening in the duodenum to treat diabetes or obesity, such as duodenal mucosal steam ablation (Aqua Medical), pulsed electric field ablation, which have minimally invasive and convenient characteristics, small trauma, fast recovery, simple operation, and can perform precise surgery, reducing the occurrence of complications.

[0004] Chinese Patent No. CN 114786605A discloses a device, system and method for pulsed electric field treatment of the duodenum. Among them, the expandable member is wound around the second elongated body to engage with tissues such as the inner surface of the duodenum when expanded. However, when in the contracted state, the expandable member is wound around the outer periphery of the second elongated body in multiple layers, resulting in a relatively large radial dimension of the expandable member, making it difficult to enter human tissues, increasing the surgical difficulty, as well as increasing the operation difficulty of the surgeon and the pain level of the patient; in addition, the expandable member also has defects such as poor tissue adhesion and inconvenient expansion and contraction adjustment operations. Summary of the Invention

[0005] The object of the present invention is to provide an electric field ablation device, ablation system and use for the digestive tract to solve one or more problems of the prior art.

[0006] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0007] An electric field ablation device for the digestive tract, comprising:

[0008] A first rod having a first proximal end and a first distal end;

[0009] A second rod having a second proximal end and a second distal end, the second rod being slidably sleeved on the first rod and exposing the first distal end;

[0010] A support member, one end of the support member being fixedly connected to the first distal end, the other end of the support member being fixedly connected to the second distal end, the support member having an expanded state with an increased lateral dimension and a contracted state with a decreased lateral dimension, and when the first distal end and the second distal end move away from each other, the support member is converted from the expanded state to the contracted state;

[0011] An electrode assembly including a plurality of electrodes, the electrodes being fixedly provided on the support member, wherein when the support member is in the expanded state, the electrodes are exposed outwards on the surface of the support member facing away from the first rod.

[0012] In some embodiments, the first rod is rotatably inserted through the rod cavity of the second rod around its own axis, so that the shape of the support member in the expanded state and / or the contracted state can be adjusted.

[0013] In some embodiments, when the support member is in the expanded state, the two ends of the support member are adjacent to each other so that the support member is annular; or, the support member has an arched portion that arches outwards away from the first rod, and the arched portion has one located on one side of the first rod or has a plurality of them separately provided on different sides of the first rod.

[0014] In some embodiments, when the support member is in the contracted state, the support member is wound around the outer circumference of the first rod along its own length direction.

[0015] In some embodiments, in the contracted state, the support member is wound around the outer circumference of the first rod in a spiral shape, and at least a part of the support member exists on different sides of the first rod.

[0016] In some embodiments, there are more than two groups of the support members, and each group of the support members is connected between the first distal end and the second distal end.

[0017] In some embodiments, in the expanded state, each set of the support members has a plurality of arched portions that are respectively disposed on opposite sides of the first rod and arched outwardly away from the first rod, and the plurality of arched portions located on the same side of the first rod are spaced apart along the length direction of the first rod.

[0018] In some embodiments, there are two sets of the support members, and the two sets of the support members are annularly arranged on the outer circumference of the first rod in opposite directions.

[0019] In some embodiments, all of the support members are simultaneously in the expanded state or simultaneously in the contracted state. Among them, a plurality of connection ends are circumferentially spaced apart on the second distal end portion, and multiple sets of the support members are correspondingly connected between the plurality of connection ends and the first distal end portion.

[0020] In some embodiments, the width direction of the support member is parallel to the length direction of the first rod, and the connection length between the support member and the first distal end portion and the connection length between the support member and the second distal end portion are both equal to the width of the support member.

[0021] In some embodiments, the width of the support member is 1 mm to 10 mm, and / or the thickness of the support member is 0.1 mm to 1 mm.

[0022] In some embodiments, the support member is made of a shape memory alloy material, the electrode assembly further includes an insulating layer, the insulating layer is fixedly disposed on the support member, and the electrode is fixedly disposed on the insulating layer.

[0023] In some embodiments, the electrode is formed on the insulating layer by etching, pasting, or plating.

[0024] In some embodiments, the insulating layer is in a strip shape, the insulating layer is fixedly connected to one side surface of the support member along the length direction, and all the electrodes are evenly spaced along the length direction of the insulating layer.

[0025] In some embodiments, the number of the electrodes is 4 to 48, and / or the width of the electrode is 0.1 mm to 5 mm.

[0026] In some embodiments, the support member is made of a shape memory alloy material, the second rod is made of a polymer material, and the second rod is injection molded so that the support member is fixedly connected to the second distal end portion;

[0027] The first rod is made of a polymer material, and the first rod is injection molded so that the support member is fixedly connected to the first distal end portion; or the first rod is made of a metal material and the support member is welded and fixed to the first distal end portion.

[0028] In some embodiments, the outer diameter of the first rod is 0.5 mm to 2 mm; the outer diameter of the second rod is 3 mm to 8 mm.

[0029] In some embodiments, the support member is formed from a strip-shaped alloy plate, and a plurality of hollow structures are provided on the support member.

[0030] In some embodiments, the electric field ablation device further includes a wire, the wire is connected to the electrode, and the wire is disposed in the rod cavity of the second rod.

[0031] Wherein, the wire and the first rod are commonly disposed in the same rod cavity of the second rod; or, the second rod has a plurality of rod cavities separated from each other, and the wire and the first rod are disposed in different rod cavities of the second rod.

[0032] An electric field ablation system for the digestive tract includes the electric field ablation device for the digestive tract as described above, and further includes an energy generating device for generating electric field energy, and the energy generating device is connected to the electrode through a wire.

[0033] Use of an electric field ablation device for the digestive tract as described above in the treatment of diabetes or obesity.

[0034] Due to the application of the above technical solutions, the present invention has the following advantages:

[0035] When the electric field ablation device provided by the present invention is used, by driving the relative sliding of the first rod and the second rod, the support member can be switched between the expanded state and the contracted state, and the operation is convenient. Wherein, when the support member is in the contracted state, it is stretched so that the lateral dimension is small, and it can conveniently enter or exit the human body and pass through various cavities of the digestive tract, thus facilitating the doctor's surgical operation and reducing the patient's pain; when the support member is in the expanded state, the lateral dimension of the support member increases, so that the electrodes on the surface of the support member can be closely attached to the tissue of the digestive tract, thereby achieving an accurate ablation treatment effect.

[0036] Connecting the above electric field ablation device to an external energy generating device for generating electric field energy can apply a pulsed electric field to the surface tissue of the digestive tract through the electrode for ablation treatment, can ablate the duodenal mucosa layer, and realize the healthy regeneration of the duodenal mucosa, thereby treating diabetes or obesity. Description of the Drawings

[0037] To more clearly illustrate the technical solution of the present invention, the following will briefly introduce the drawings required for the description of the embodiments. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0038] Figure 1 It is a schematic structural diagram of the electric field ablation device according to Embodiment 1 of the present invention, where the support member is in an expanded state;

[0039] Figure 2 For Figure 1 It is a schematic structural diagram of the support member of the electric field ablation device before being formed;

[0040] Figure 3 For Figure 2 It is a schematic diagram of the principle of the support member being formed by a mold;

[0041] Figure 4 It is a schematic connection structure diagram of the electrode assembly on the support member;

[0042] Figure 5 It is a schematic structural diagram when the support member has not been connected to the second rod;

[0043] Figure 6 It is a schematic cross-sectional diagram at the connection position of the support member and the second rod;

[0044] Figure 7 For Figure 1 It is a schematic structural diagram of the support member after the transformation of the electric field ablation device;

[0045] Figure 8 For Figure 1 It is a schematic structural diagram of the support member after being transformed to the contracted state in the electric field ablation device;

[0046] Figure 9 It is a schematic structural diagram of the electric field ablation device according to Embodiment 2 of the present invention, where the support member is in an expanded state;

[0047] Figure 10 For Figure 9 It is a schematic structural diagram after removing the electrode assembly on the basis of

[0048] Figure 11 It is a schematic structural diagram of the electric field ablation device according to Embodiment 3 of the present invention, where the support member is in an expanded state;

[0049] Figure 12 It is a schematic structural diagram of the electric field ablation device according to Embodiment 4 of the present invention, where the support member is in an expanded state;

[0050] In the above drawings:

[0051] 1. First rod; 1a. First distal end portion; 1b. First proximal end portion;

[0052] 2. Second rod; 2a. Second distal end portion; 2b. Second proximal end portion; 21. Connecting end head;

[0053] 3. Support member; 31. Arch portion; 32. Hollow structure; 30. Through hole;

[0054] 4. Electrode assembly; 41. Electrode; 42. Insulating layer; 43. Adhesive layer;

[0055] 5. Conducting wire; 6. Molding die. Detailed implementation manners

[0056] The following elaborates on the preferred embodiments of the present invention in conjunction with the accompanying drawings, so that the advantages and features of the present invention can be more easily understood by those skilled in the art. It should be noted here that the description of these embodiments is for helping to understand the present invention, but does not constitute a limitation to the present invention. In addition, the technical features involved in the various embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0057] In this article, "proximal" and "distal" are defined based on the distance of the electric field ablation device from the operator after the electric field ablation device is inserted into the human body. Specifically, the "distal end portion" refers to the end portion far from the operator, and is also referred to as the "front end portion"; the "proximal end portion" refers to the end portion close to the operator, and is also referred to as the "rear end portion".

[0058] Embodiment 1

[0059] Refer to Figure 1 、 Figures 7 to 8 A kind of electric field ablation device for the digestive tract shown, which includes:

[0060] A first rod 1, the first rod 1 has a first proximal end portion 1b and a first distal end portion 1a;

[0061] A second rod 2, the second rod 2 has a second proximal end portion 2b and a second distal end portion 2a, the second rod 2 is slidably sleeved on the first rod 1 and exposes the first distal end portion 1a;

[0062] A support member 3, one end portion of the support member 3 is fixedly connected to the first distal end portion 1a, and the other end portion of the support member 3 is fixedly connected to the second distal end portion 2a. The support member 3 has an expanded state with an increasing transverse dimension and a contracted state with a decreasing transverse dimension. When the first rod 1 and the second rod 2 slide relative to each other so that the first distal end portion 1a and the second distal end portion 2a move away from each other, the support member 3 is converted from the expanded state to the contracted state;

[0063] The electrode assembly 4, which includes a plurality of electrodes 41 fixedly disposed on the support member 3. When the support member 3 is in the expanded state, the electrodes 41 are exposed outwardly from the surface of the support member 3 facing away from the first rod 1, so as to be able to fit with the tissue of the digestive tract for ablation treatment.

[0064] It should be noted that the "lateral direction" here is relative to the "longitudinal direction". Among them, the length extension directions of the first rod 1 and the second rod 2 are the longitudinal directions, and the lateral direction is the other direction perpendicular to the length extension directions of the first rod 1 and / or the second rod 2.

[0065] Specifically, when the support member 3 is in the expanded state, as Figure 1 shown, when the two ends of the support member 3 are adjacent, that is, when the first distal end 1a and the second distal end 2a approach each other, the support member 3 is annular, and at this time the lateral dimension of the support member 3 is the largest; another example is Figure 7 shown, when the two ends of the support member 3 have a certain distance in the length extension direction of the first rod 1, that is, the first distal end 1a and the second distal end 2a are spaced apart, the support member 3 has an arched portion 31 that arches outwardly away from the first rod 1, and there are two arched portions 31 located on opposite sides of the first rod 1. At this time, the lateral dimension of the support member 3 is smaller than that in the Figure 1 state shown. Of course, in other embodiments, when the support member 3 is in the expanded state, it may also be presented as having one arched portion 31 located on one side of the first rod 1, or multiple arched portions 31 separately provided on opposite sides of the first rod 1.

[0066] When the support member 3 is in the contracted state, as Figure 8 shown, the first distal end 1a and the second distal end 2a move away from each other, causing the support member 3 to be stretched along its own length direction, so that the lateral dimension of the support member 3 is greatly reduced. Here, in the contracted state, the support member 3 is wound around the circumferential outer side of the first rod 1 along its own length direction, specifically wound around the circumferential outer side of the first rod 1 in a spiral shape, and there is at least a part of the support member 3 on both opposite sides of the first rod 1. In this way, the lateral dimension of the support member 3 can be greatly reduced, so as to facilitate entry and exit from the human digestive tract.

[0067] In this embodiment, the first rod 1 is also rotatably inserted through the rod cavity of the second rod 2 around its own axis. In this way, when the support member 3 is in the expanded state, the shape of the support member 3 can be adjusted by rotating the first rod 1, so that the support member 3 has different lateral dimensions and different lengths, enabling the electrodes 41 thereon to contact the tissue in different ways to achieve different treatment effects; when the support member 3 is in the contracted state, the shape of the support member 3 can also be adjusted by rotating the first rod 1, enabling the support member 3 to be wound around the first rod 1 in different ways, so that the lateral dimension of the support member 3 can be adjusted to the minimum, facilitating the insertion of the ablation device into the human digestive tract or withdrawal from the human digestive tract.

[0068] The support member 3 is specifically made of a shape memory alloy material. The maximum lateral dimension of the support member 3 in the expanded state is the heat-set shape of the shape memory alloy, and the heat-set temperature is usually about 500 degrees Celsius. In this embodiment, a nickel-titanium alloy material is used, and the support member 3 is obtained by molding nickel-titanium alloy sheets through a specific mold. As Figure 2 shown, the support member 3 is in a long strip shape before being molded, with a width preferably of 1 mm to 10 mm and a thickness preferably of 0.1 mm to 1 mm.

[0069] During molding, as Figure 3 shown, the long strip-shaped nickel-titanium alloy sheet is wrapped around the outer circumference of a cylindrical molding mold 6 with a corresponding diameter, and then placed in a high-temperature furnace at about 500 degrees Celsius, kept warm for about 15 minutes and then water-cooled to obtain the required support member 3. In human tissue, if no external force is applied, the support member 3 can automatically return from the contracted state to the expanded state at the maximum diameter through temperature-induced phase change.

[0070] The electrode assembly 4 further includes an insulating layer 42, which is fixedly arranged on the support member 3, and the electrodes 41 are fixedly arranged on the insulating layer 42. Specifically, the insulating layer 42 is in a strip shape, with a width, length and the support member 3 being basically the same; the insulating layer 42 is fixedly connected to one side surface of the support member 3 along the length direction, and all the electrodes 41 are evenly spaced in the length direction of the insulating layer 42.

[0071] The material of the insulating layer 42 can be a high breakdown voltage-resistant material such as polyimide or polyethylene terephthalate. The insulating layer 42 is fixedly bonded to the support member 3 with glue, forming an adhesive layer 43 between the insulating layer 42 and the support member 3, as Figure 4 shown. The electrode assembly 4 is integrally flexible and can deform accordingly with the deformation of the support member 3, so that the positions of the electrodes 41 on the surface of the support member 3 are relatively fixed.

[0072] The electrode 41 is specifically a metal electrode, and the material of the metal electrode can be conductive materials such as copper, silver, platinum, gold, and stainless steel. The electrode 41 can be formed on the insulating layer 42 by means of etching, pasting, or plating; the number of the electrodes 41 is specifically 4 to 48, and can be designed according to the maximum lateral dimension of the support 3; the width of the electrode 41 is preferably 0.1 mm to 5 mm.

[0073] The electric field ablation device further includes a wire 5, and each electrode 41 is connected to an external energy generating device through a lacquer-coated wire used as the wire 5. Specifically, the wire 5 is disposed in the rod cavity of the second rod 2. As Figure 1 shown, the second rod 2 is a multi-cavity tube, which has at least two mutually independent rod cavities that penetrate along the length direction respectively, and the wire 5 and the first rod 1 are disposed in different rod cavities of the second rod 2. In some other embodiments, the wire 5 and the first rod 1 can also be disposed in the same rod cavity of the second rod 2.

[0074] In this ablation device, the width direction of the support 3 is parallel to the length direction of the first rod 1, and the connection lengths between the support 3 and the first distal end portion 1a and between the support 3 and the second distal end portion 2a are both equal to the width of the support 3. That is to say, the support 3 is entirely connected to the first rod 1 and the second rod 2 in the width direction, so that the connection between the support 3 and the first rod 1 and the second rod 2 at the connection position is more stable and reliable, and is not easy to fall off.

[0075] In this embodiment, the second rod 2 is made of a polymer material, specifically, it can be a polymer material such as nylon, polyimide, and polyethylene. The second rod 2 is injection-molded so that the support 3 is fixedly connected to the second distal end portion 2a. Specifically, referring to Figure 5 shown, through holes 30 are pre-opened at the end of the support 3. The diameter of the through holes 30 can be between 0.2 and 2 mm, and the number is not limited. They can be arranged at intervals along the width direction of the support 3, and are preferably arranged at uniform intervals; then, the support 3 is used as an insert to perform injection molding on the second distal end portion 2a of the second rod 2, so that part of the material of the second rod 2 can flow into the through holes 30 of the support 3 in a molten state to form an integral body during injection molding. In this way, an effective connection can be achieved between the metal support 3 and the polymer material second rod 2, and it is ensured that they will not fall off during the movement during use. In other embodiments, grooves can also be processed at the end of the support 3. The width of the groove is the same as the thickness of the support 3, and the maximum depth does not exceed the radius of the second rod 2. Then, the second rod 2 is inserted into the aforementioned groove, and the electrode wire channel on the second rod 2 is prevented from closing by inserting a metal wire. It is placed under a heating device for welding. After welding, the second rod 2 can still be embedded in the groove of the support 3, thereby improving the bonding force between the second rod 2 and the support 3 and preventing the two from falling off.

[0076] The outer diameter of the main body portion of the second rod 2 is preferably 3 mm to 8 mm, and the outer diameter of the first rod 1 is preferably 0.5 mm to 2 mm. In this embodiment, a connecting end 21 is provided on the second distal end portion 2a of the second rod 2. The outer diameter of the connecting end 21 is close to the outer diameter of the first rod 1, and the connecting end 21 and the support member 3 are connected thereto.

[0077] In this embodiment, the first rod 1 is made of a polymer material, and it also adopts a connection method similar to that of the second rod 2 and the support member 3, that is, the support member 3 is fixedly connected to the first distal end portion 1a by injection molding. In other embodiments, the first rod 1 can also be made of a metal material. At this time, one end portion of the support member 3 can be welded and fixed to the first distal end portion 1a of the first rod 1 by welding. Specifically, when setting, the connection position of the support member 3 on the first distal end portion 1a has a certain distance from the tip position of the first rod 1, which enables the ablation device to rely on the guidance of the tip of the first rod 1 when initially entering the human body, making the size of the part initially entering the human digestive tract smaller and more smooth when entering.

[0078] When inserting the electric field ablation device into the human digestive tract or withdrawing it from the human digestive tract, the operator can first drive the first rod 1 to slide relative to the second rod 2, so that the first distal end portion 1a and the second distal end portion 2a move away from each other, and the support member 3 is in a contracted state, forming as Figure 8 the state shown. In this way, the lateral dimension of the support member 3 is greatly reduced, and it can enter or exit the human body conveniently, and can pass through various cavities of the digestive tract conveniently, thus facilitating the doctor's surgical operation and reducing the patient's pain; when the electric field ablation device reaches the position to be treated in the human digestive tract, the first distal end portion 1a and the second distal end portion 2a are driven to approach each other, so that the support member 3 is converted into an expanded state, and the lateral dimension of the support member 3 increases, and the plurality of electrodes 41 on the surface of the support member 3 can be closely attached to the tissue of the digestive tract, thereby realizing the ablation treatment of the digestive tract. At the same time, when facing digestive tracts with different diameters, only by driving the first rod 1 and the second rod 2 to slide axially relative to each other, the support member 3 can be deformed accordingly, so that the electrodes 41 on the surface of the support member 3 can be closely attached to the tissue, achieving an accurate ablation effect, and the operation and adjustment are relatively convenient.

[0079] Embodiment 2

[0080] Refer to Figure 9 、 Figure 10 the electric field ablation device shown. Compared with Embodiment 1, the main difference is that in this embodiment, a plurality of hollow structures 32 are provided on the support member 3. Specifically here, the support member 3 has hollow structures 32 extending in the length direction, forming a plurality of parallel strip structures, and the electrode assembly 4 is connected between these parallel strips.

[0081] By providing the above-mentioned hollow structure 32 on the support member 3, the difficulty of deformation of the support member 3 can be reduced, facilitating the adjustment of the lateral dimension of the support member 3 by driving the relative movement of the first rod 1 and the second rod 2.

[0082] Embodiment 3

[0083] Refer to Figure 11 the electric field ablation device shown. Compared with Embodiment 2, the main difference lies in that the structure of the hollow structure 32 is different. In this embodiment, the hollow structure 32 is a plurality of hollow holes provided on the support member 3. Here, the plurality of hollow holes are arranged in an array on the support member 3, and the hollow holes are rectangular holes.

[0084] Of course, in other embodiments, the hollow structure 32 can also be designed in other structural forms, all of which can make the support member 3 more easily deformed to facilitate conversion between different forms.

[0085] Embodiment 4

[0086] This reference Figure 12 As shown, in this embodiment, there are two sets of support members 3, and each set of support members 3 is connected between the first distal end portion 1a and the second distal end portion 2a. When the first rod 1 moves relative to the second rod 2, one end portion of the two sets of support members 3 will be driven to move relative to the other end portion thereof, so that the two sets of support members 3 are simultaneously in an expanded state or simultaneously in a contracted state. In the expanded state, the forms of the two sets of support members 3 are different.

[0087] Specifically, each set of support members 3 has a plurality of arched portions 31 that are respectively provided on different sides of the first rod 1 and arched outwardly away from the first rod 1. The plurality of arched portions 31 located on the same side of the first rod 1 are spaced apart along the length direction of the first rod 1. Here, the two sets of support members 3 are annularly arranged on the outer circumference of the first rod 1 in opposite directions. In the expanded state of the support member 3, the two sets of support members 3 respectively form two arched portions 31 on different sides of the first rod 1, and the positions of the two arched portions 31 correspond one by one. Two connection ends 21 are circumferentially spaced on the second distal end portion 2a of the second rod 2, and the two sets of support members 3 are correspondingly connected between the plurality of connection ends 21 and the first distal end portion 1a.

[0088] In other embodiments, the above-mentioned support members 3 can also be provided with more than two sets. Preferably, these multiple sets of support members 3 have different forms in the expanded state and / or are located at different positions in the length direction of the first rod 1, and at least two sets of support members 3 are annularly arranged on the outer circumference of the first rod 1 in opposite directions.

[0089] By providing multiple sets of support members 3, it is possible to ensure that the support members 3 in the expanded state have a large contact area in the length extension direction of the first rod 1. In this way, as many electrodes 41 as possible can be arranged, so that a larger area can be ablated during one ablation, thereby improving the ablation efficiency.

[0090] Connect the above-mentioned electric field ablation device to an external energy generating device for generating electric field energy through a wire 5 to form an electric field ablation system for the digestive tract. When the energy generating device operates, a pulsed electric field is applied to the surface tissue of the digestive tract through the electrodes 41 for ablation treatment, which can ablate the duodenal mucosa layer and achieve healthy regeneration of the duodenal mucosa, thereby treating diabetes or obesity. The present invention does not limit the parameters such as the voltage, frequency, and pulse width applied by the energy generating device and the energy device.

[0091] It can be understood that the same or similar parts in the above embodiments can be referred to each other, and the content not detailed in some embodiments can be referred to the same or similar content in other embodiments.

[0092] Unless otherwise specifically defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art. If there are contradictions or inconsistencies between the definitions used herein and those set forth in other published documents, the definitions used herein shall prevail.

[0093] As shown in this specification and the claims, the terms "comprising" and "including" only indicate the inclusion of the clearly identified steps and elements, and these steps and elements do not constitute an exclusive list. A method or device may also include other steps or elements.

[0094] Furthermore, it can be understood that "a plurality of" in the present disclosure means two or more, and other quantifiers are similar thereto. "And / or" describes the association relationship of associated objects and indicates that three relationships may exist. For example, A and / or B may represent: A exists alone, A and B exist simultaneously, and B exists alone. The character " / " generally represents an "or" relationship between the associated objects before and after. The singular forms of "a", "the", and "said" are also intended to include the plural forms, unless the context clearly indicates otherwise.

[0095] Furthermore, it can be understood that the terms "first", "second", etc. are used to describe various information, but this information should not be limited to these terms. These terms are only used to distinguish the same type of information from each other and do not represent a specific order or importance. In fact, the expressions "first", "second", etc. can be used interchangeably. For example, without departing from the scope of the present disclosure, the first information can also be referred to as the second information, and similarly, the second information can also be referred to as the first information.

[0096] The above embodiments are only used to illustrate the technical concept and features of the present invention, and the purpose is to enable those skilled in the art to understand the content of the present invention and implement it accordingly. It is not intended to limit the protection scope of the present invention. Any equivalent changes or modifications made according to the essence of the present invention should be covered within the protection scope of the present invention.

Claims

1. An electric field ablation device for the digestive tract, characterized in that, The electric field ablation device includes: A first rod having a first proximal end and a first distal end; A second rod having a second proximal end and a second distal end, the second rod being slidably sleeved on the first rod and exposing the first distal end; A support member, one end of the support member being fixedly connected to the first distal end, the other end of the support member being fixedly connected to the second distal end, the support member having an expanded state with an increased lateral dimension and a contracted state with a decreased lateral dimension, when the first distal end and the second distal end move away from each other, the support member is converted from the expanded state to the contracted state; An electrode assembly including a plurality of electrodes, the electrodes being fixedly provided on the support member, wherein when the support member is in the expanded state, the electrodes expose outwardly from the surface of the support member facing away from the first rod.

2. The electric field ablation device for the digestive tract according to claim 1, wherein The first rod is rotatably inserted through the rod cavity of the second rod about its own axis, so that the shape of the support member in the expanded state and / or the contracted state can be adjusted.

3. The electric field ablation device for the digestive tract according to claim 1, characterized in that, When the support member is in the expanded state, the two ends of the support member are adjacent to each other so that the support member is annular; or, the support member has an arched portion that arches outwardly away from the first rod, and the arched portion has one located on one side of the first rod or has a plurality of them distributed on different sides of the first rod.

4. The electric field ablation device for the digestive tract according to claim 1, wherein When the support member is in the contracted state, the support member is wound around the outer circumference of the first rod along its own length direction.

5. The electric field ablation device for the digestive tract according to claim 4, characterized in that, In the contracted state, the support member is spirally wound around the outer circumference of the first rod, and at least a part of the support member exists on different sides of the first rod.

6. The electric field ablation device for the digestive tract according to claim 1, characterized in that, There are more than two groups of the support members, and each group of the support members is connected between the first distal end and the second distal end.

7. The electric field ablation device for the digestive tract according to claim 6, wherein In the expanded state, each group of the support members has a plurality of arched portions that are distributed on different sides of the first rod and arch outwardly away from the first rod, and the plurality of arched portions located on the same side of the first rod are spaced apart along the length direction of the first rod.

8. The electric field ablation device for the digestive tract according to claim 6, characterized in that, There are two groups of the support members, and the two groups of the support members are wound around the outer circumference of the first rod in opposite directions.

9. The electric field ablation device for the digestive tract according to claim 6, characterized in that, All the support members are simultaneously in the expanded state or simultaneously in the contracted state, wherein a plurality of connection ends are circumferentially spaced on the second distal end, and multiple groups of the support members are correspondingly connected between the multiple connection ends and the first distal end.

10. The electric field ablation device for the digestive tract according to claim 1, characterized in that, The width direction of the support member is parallel to the length direction of the first rod, and the connection length of the support member with the first distal end and the connection length of the support member with the second distal end are both equal to the width of the support member.

11. The electric field ablation device for the digestive tract according to claim 1, wherein The width of the support member is 1 mm to 10 mm, and / or the thickness of the support member is 0.1 mm to 1 mm.

12. The electric field ablation device for the digestive tract according to claim 1, characterized in that, The support member is made of a shape memory alloy material, the electrode assembly further includes an insulating layer, the insulating layer is fixedly provided on the support member, and the electrodes are fixedly provided on the insulating layer.

13. The electric field ablation device for the digestive tract according to claim 12, characterized in that, The electrodes are formed on the insulating layer by means of etching, pasting, or plating.

14. The electric field ablation device for the digestive tract according to claim 12, wherein The insulating layer is strip-shaped and is fixedly connected to one side surface of the support member along the length direction, and all the electrodes are evenly spaced along the length direction of the insulating layer.

15. The electric field ablation device for the digestive tract according to claim 12, characterized in that, The number of the electrodes is 4 to 48, and / or the width of the electrodes is 0.1 mm to 5 mm.

16. The electric field ablation device for the digestive tract according to claim 1, characterized in that, The support member is made of a shape memory alloy material, the second rod is made of a polymer material, and the second rod is injection molded so that the support member is fixedly connected to the second distal end portion; The first rod is made of a polymer material, and the first rod is injection molded so that the support member is fixedly connected to the first distal end portion; or the first rod is made of a metal material and the support member is welded and fixed to the first distal end portion.

17. The electric field ablation device for the digestive tract according to claim 1, characterized in that, The outer diameter of the first rod is 0.5 mm to 2 mm; and / or the outer diameter of the second rod is 3 mm to 8 mm.

18. The electric field ablation device for the digestive tract according to claim 1, characterized in that, The support member is formed by shaping a strip-shaped alloy plate, and a plurality of hollow structures are provided on the support member.

19. The electric field ablation device for the digestive tract according to claim 1, wherein: The electric field ablation device further includes a wire, the wire is connected to the electrode, and the wire is disposed in the rod cavity of the second rod. Among them, the wire and the first rod are jointly disposed in the same rod cavity of the second rod; or, the second rod has a plurality of rod cavities separated from each other, and the wire and the first rod are disposed in different rod cavities of the second rod.

20. An electric field ablation system for the digestive tract, characterized in that: It includes an electric field ablation device for the digestive tract according to any one of claims 1 to 19, and further includes an energy generating device for generating electric field energy, and the energy generating device is connected to the electrode through a wire.

21. Use of an electric field ablation device for the digestive tract according to any one of claims 1 to 19 in the treatment of diabetes or obesity.

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