Electric field ablation device and ablation system for digestive tract

Abstract

The invention relates to an electric field ablation device and ablation system for digestive tracts, the electric field ablation device comprises a slender carrier and an ablation main body, the ablation main body comprises a supporting piece and an electrode assembly, the supporting piece is arranged on the slender carrier, the electrode assembly comprises a plurality of electrodes, and the electrodes are arranged on the supporting piece. All the electrodes are distributed on the outer side of the supporting piece at intervals, and the supporting piece can be arranged in a deformation mode so that the ablation body can have a first state in which the transverse size becomes large and a second state in which the transverse size becomes small; wherein the long and thin carrier is provided with an endoscope channel which penetrates in the axial direction and can allow an endoscope to penetrate through, so that the electric field ablation device can be arranged on the endoscope in a sleeving mode and can enter the alimentary canal of the human body together with the endoscope or retreat from the alimentary canal, and operation is more convenient.

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 and an ablation system having 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 the inability of glucose to effectively enter cells for energy supply, 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. China has the largest number of diabetic patients in the world, and the prevalence has been continuously rising in recent years. As of 2025, the number of diabetic patients in China has exceeded 140 million, accounting for nearly one-fourth of the total global 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 the operation, and the recurrence rate within 5 years is less than 20%. It is especially suitable for severely obese (BMI≥35 kg / m 2 ) patients, but it requires general anesthesia and laparoscopic / open abdominal surgery. Postoperative complications may include anastomotic leakage, malnutrition (such as iron / calcium deficiency), dumping syndrome, etc., and the recovery time is long. The anatomical structure is permanently changed (such as a reduced gastric volume), and the original physiological state cannot be restored after the operation, and the difficulty of secondary surgery is high.

[0004] In the prior art, there are also means of treating diabetes or obesity by intervening in the duodenum. For example, duodenal mucosal steam ablation (Aqua Medical), pulsed electric field ablation, which have the advantages of minimally invasive and convenient, with small trauma, quick recovery, simple operation and precise surgery, reducing the occurrence of complications. However, due to their own structural reasons, the ablation instruments in the prior art have different ways of entering the target lesion area. For example, the pulsed ablation instrument provided by Endogenex, due to its coiled metal electrode structure, has a relatively large outer diameter after coiling, and can only enter the duodenal area through the oral cavity in a manner parallel to the endoscope. This method increases the difficulty of the instrument entering from the oral cavity, as well as the discomfort of the patient, the operation difficulty of the doctor and the risk of possible injury to the patient. Another example is the duodenal mucosal steam ablation system provided by Aqua Medical. The design of this system enables the treatment instrument to enter the human body through the internal channel of the endoscope, thus reducing the problems brought by the accompanying manner with the endoscope. However, this requires that the ablation instrument can pass through the small endoscope channel when not expanded, and can have a large enough diameter after expansion to fit the inner wall of the digestive tract. This requires high manufacturing technology for the ablation instrument and also limits the design of the ablation instrument structure, resulting in the ablation instrument not being able to fit well with the inner wall of the digestive tract during expansion, affecting the ablation treatment effect. Summary of the Invention

[0005] The object of the present invention is to provide an electric field ablation device that can be sleeved on an endoscope and thus can enter and exit the human digestive tract synchronously with the endoscope.

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

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

[0008] An elongated carrier;

[0009] An ablation main body, the ablation main body comprising a support member and an electrode assembly, the support member being disposed on the elongated carrier, the electrode assembly comprising a plurality of electrodes, all of the electrodes being spaced apart and distributed outside the support member, the support member being deformably disposed such that the ablation main body has a first state with a larger transverse dimension and a second state with a smaller transverse dimension;

[0010] Wherein, an endoscope channel axially penetrating through and capable of allowing an endoscope to pass through is provided on the elongated carrier.

[0011] Preferably, the electric field ablation device further includes a distal end head, which is fixedly provided on the distal end of the slender carrier and is connected to one end of the support member. The distal end head has a hollow channel axially penetrating therethrough, and the endoscope can be cooperatively passed through the hollow channel and fixedly engaged with the distal end head.

[0012] In some embodiments, the distal end head is made of a flexible material, and when the endoscope is inserted into the hollow channel, it is connected to the inner wall of the hollow channel in an interference fit manner.

[0013] As a preferred embodiment, the slender carrier includes a base rod, the support member is sleeved on the outer circumference of the base rod, and the endoscope channel is provided on the base rod.

[0014] Optionally, the center line of the endoscope channel extends collinearly with the axis line of the base rod.

[0015] Optionally, the support member is a balloon having a balloon cavity. The balloon is fixedly sleeved on the base rod, and at least a part of the base rod is inserted into the balloon cavity. Wherein, a liquid flow channel is provided on the base rod, and a through hole is also formed on the base rod. The through hole communicates the balloon cavity with the liquid flow channel, and the endoscope channel and the liquid flow channel are not communicated with each other.

[0016] Optionally, all the electrodes are spaced apart in the circumferential direction of the balloon. Wherein, the electrode assembly further includes a base, the base is fixedly connected to the surface of the balloon, and the base is deformable in a flexible manner to deform correspondingly with the expansion and contraction of the balloon, and the electrode is fixedly provided on the base.

[0017] Optionally, the base is adhesively fixed to the surface of the balloon; and / or, the electrode is formed on the base by etching, pasting, or plating.

[0018] Optionally, the base has a base portion and two extending portions located on both sides of the base portion. The electrode is provided on the base portion, and the extending portions extend away from the base portion to the end of the balloon and are fixedly connected to the base rod. Wherein, there are multiple groups of the base distributed at intervals in the circumferential direction, and multiple groups of the bases respectively connect the balloon and the base rod, or all the bases are joined together to form an integral base with a mesh structure.

[0019] Optionally, the electrode assembly further includes a wire, the wire is connected to the electrode, and a wire channel for the wire to pass through is also provided on the base rod. The wire channel, the liquid flow channel, and the endoscope channel are not communicated with each other.

[0020] Optionally, the wire channel and the liquid flow channel are located on the same side of the endoscope channel, and the wire channel and the liquid flow channel are arranged at a radial interval along the base rod.

[0021] As another preferred embodiment, the elongated carrier includes a first rod and a second rod that are slidably connected axially, the support member is connected between the first rod and the second rod, and when the first rod and the second rod move relative to each other axially, the ablation body is switched between the first state and the second state.

[0022] Optionally, the first rod has a first proximal end and a first distal end, the second rod has a second proximal end and a second distal end, the first rod and the second rod are sleeved and slidably connected axially, one end of the support member is fixedly connected to the first distal end, the other end of the support member is fixedly connected to the second distal end, and when the distance between the first distal end and the second distal end increases, the ablation body is switched from the first state to the second state.

[0023] Optionally, the support member is a metal stent that can expand and contract, the metal stent is sleeved on the outer circumference of the first rod, the front end of the metal stent is connected to the first distal end, the proximal end of the metal stent is connected to the second distal end, and all the electrodes are distributed at intervals in the circumferential direction of the metal stent, wherein the endoscope channel is opened on the first rod.

[0024] Optionally, the electrodes are fixedly connected to the surface of the metal stent;

[0025] Alternatively, the electrode assembly further includes electrode support rods, the electrode support rods are connected between the first distal end and the second distal end, the electrodes are fixed on the electrode support rods, wherein there are multiple electrode support rods that are distributed at intervals in the circumferential direction outside the metal stent, and each electrode support rod is arranged to be able to deform flexibly so as to be able to fit on the surface of the metal stent.

[0026] Optionally, the metal stent includes multiple support rods, the multiple support rods are cross - arranged to form a network structure, wherein at least two support rods are joined and extend in different directions to form the network structure, and a joint portion is formed at the position where the at least two support rods are joined, and the electrodes are fixedly connected to the joint portion.

[0027] Optionally, the support member is a metal strip, the metal strip can be spirally wound around the outer circumference of the first rod, the electrodes are fixedly arranged on the metal strip, and the electrodes are exposed outward from the surface of the metal strip facing away from the first rod, wherein the endoscope channel is opened on the first rod.

[0028] Optionally, in the first state, the metal strip 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 multiple ones respectively disposed on different sides of the first rod.

[0029] Another object of the present invention is to provide an ablation system with the above-mentioned electric field ablation device. The electric field ablation system includes the electric field ablation device for the digestive tract as described above. The electric field ablation system further includes an endoscope that is inserted through the endoscope channel, and the distal end of the endoscope protrudes in front of the slender carrier.

[0030] Optionally, the electric field ablation system further includes an energy device for generating electric field energy, and the energy device is connected to the electrode through a wire.

[0031] Due to the application of the above technical solutions, the present invention has the following advantages:

[0032] The electric field ablation device and ablation system provided by the embodiments of the present invention, wherein an endoscope channel axially penetrating and capable of allowing an endoscope to pass through is provided on the slender carrier, so that the electric field ablation device can be sleeved on the endoscope, and thus can enter or exit the human digestive tract together with the endoscope, which is more convenient to operate and makes it easier for doctors to more clearly observe the internal conditions of the human digestive tract during the surgical operation. At the same time, for the electric field ablation device, only an endoscope channel needs to be added, which does not affect the overall structure and operation of the electric field ablation device, making it easier to manufacture. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] In order to more clearly illustrate the technical solutions of the present invention, the drawings required for description in the embodiments will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0034] Figure 1 It is a schematic structural diagram of the electric field ablation system according to Embodiment 1 of the present invention, wherein the ablation main body is in the first state;

[0035] Figure 2 is Figure 1 the internal structural diagram of the electric field ablation system;

[0036] Figure 3 is Figure 2 the structural diagram of the electric field ablation system when the ablation main body is switched to the second state;

[0037] Figure 4Schematic diagram of the principle for an endoscope to independently enter the digestive tract;

[0038] Figure 5 It is Figure 1 Schematic diagram of the principle for the electric field ablation system of to enter the digestive tract;

[0039] Figure 6 It is Figure 5 Schematic diagram after adding a guide wire channel to the electric field ablation device on the basis of ;

[0040] Figure 7 It is Figure 1 Schematic diagram of another structure of the ablation main body in the electric field ablation system of ;

[0041] Figure 8 It is Figure 1 Schematic diagram of yet another structure of the ablation main body in the electric field ablation system of ;

[0042] Figure 9 It is Figure 1 Schematic diagram of a specific structure of the base rod in the electric field ablation system of ;

[0043] Figure 10 Schematic diagram of the structure of the electric field ablation system according to Embodiment 2 of the present invention, where the ablation main body is in the first state;

[0044] Figure 11 It is Figure 10 Schematic diagram of the structure when the ablation main body in the electric field ablation system of is converted to the second state;

[0045] Figure 12 It is Figure 10 Schematic diagram of the structure after adopting an ablation main body with another structure on the basis of the electric field ablation system of , where the ablation main body is in the first state;

[0046] Figure 13 It is Figure 10 Schematic diagram of the structure after adopting an ablation main body with yet another structure on the basis of the electric field ablation system of , where the ablation main body is in the second state;

[0047] Figure 14 It is Figure 10 Schematic diagram of a structure of the ablation main body in the electric field ablation system of ;

[0048] Figure 15 It is Figure 10 Schematic diagram of a structure of the ablation main body in the electric field ablation system of ;

[0049] Figure 16 Schematic diagram of the structure of the electric field ablation device according to Embodiment 3 of the present invention, where the ablation main body is in the first state;

[0050] Figure 17 is Figure 16 the front view structural schematic diagram of

[0051] Figure 18 is Figure 16 in the electric field ablation device of

[0052] Figure 19 is a structural schematic diagram of the ablation system of an electric field ablation device with Figure 16 ;

[0053] In the above drawings:

[0054] 1. Base rod; 11. Cylindrical rod; 12. Arc rod; 121. Arc groove; 1a. Endoscope channel; 1b. Liquid flow channel; 1c. Wire channel; 1d. Through hole; 1e. Guide wire channel;

[0055] 2. Ablation body; 21. Balloon; 22. Electrode assembly; 221. Electrode; 222. Base; 222a. Base part; 222b. Extension part; 223. Wire; 23. Metal stent; 231. Support rod; 232. Joint part; 24. Electrode; 25. Electrode support rod; 26. Metal strip;

[0056] 3. Terminal end;

[0057] 4. Endoscope; 41. Distal end part of the endoscope; 42. Endoscope wire body;

[0058] 5. First rod; 5A. First distal end part;

[0059] 6. Second rod; 6A. Second distal end part;

[0060] 7. Energy device;

[0061] 100. Digestive tract. Specific embodiments

[0062] Referring to the drawings, an electric field ablation device for the digestive tract provided by the present invention, and an ablation system having the electric field ablation device, wherein the electric field ablation device includes an elongated carrier and an ablation body 2, and the elongated carrier is used to carry the ablation body 2 and send the ablation body 2 to the treatment site of the digestive tract to be treated; the ablation body 2 is used to contact the tissue of the digestive tract so as to be able to apply a pulsed electric field to the surface tissue of the digestive tract for ablation treatment during operation.

[0063] The ablation body 2 includes a support member and an electrode assembly 22. The support member is disposed on the elongated carrier. The electrode assembly 22 includes a plurality of electrodes, and all the electrodes are spaced apart and distributed on the outer side of the support member. The support member is deformably disposed such that the ablation body 2 has a first state with a larger lateral dimension and a second state with a smaller lateral dimension. When it is necessary to insert the ablation device into the human digestive tract or withdraw it from the digestive tract, the ablation body 2 is converted to the second state. When the ablation body 2 is in the digestive tract for ablating the tissue of the digestive tract, the ablation body 2 is converted to the first state so that the electrodes on the outer side of the support member can fit against the digestive tract tissue for ablation treatment. It should be noted that the lateral direction here is relative to the longitudinal direction. The elongation direction of the elongated carrier is the longitudinal direction, and the lateral direction refers to the other direction perpendicular to the elongation direction of the elongated carrier.

[0064] In this electric field ablation device, an endoscope channel 1a is also provided on the elongated carrier and axially penetrates to allow the endoscope 4 to pass through. In this way, the electric field ablation device can be sleeved on the endoscope 4 and enter or exit the human digestive tract together with the endoscope 4, which is more convenient for operation. At the same time, for the electric field ablation device, only the endoscope channel 1a needs to be added, which does not affect the overall structure and operation of the electric field ablation device, and is easier to manufacture.

[0065] The above-mentioned electric field ablation device is sleeved on the endoscope 4 for use, so that the distal end portion 41 of the endoscope penetrates to the front of the endoscope channel 1a, and the distal end portion 41 of the endoscope is located in front of the elongated carrier and the ablation body 2. The electric field ablation device is connected to the energy device 7 through a wire to form an electric field ablation system, which can be used for the treatment of the human digestive tract. During use, the endoscope 4 and the ablation body 2 can be jointly inserted into or withdrawn from the human digestive tract. At the same time, the distal end portion 41 of the endoscope is located in front of the ablation body 2, which makes it easier for the doctor to clearly observe the internal situation of the human digestive tract during the surgical operation when the ablation body 2 enters the human digestive tract.

[0066] Specifically, the diameter of the above-mentioned endoscope channel 1a is 4 mm to 15 mm, which can be compatible with most models of endoscopes on the market. On this basis, the outer diameter of the elongated carrier can be set to 5 mm to 18 mm, and on the basis of carrying the deformable ablation body 2, it can smoothly pass through various channels of the human digestive tract.

[0067] As shown in the various attached drawings, the electric field ablation device further includes a distal end head 3, which is also known as the TIP head. It is fixedly provided on the distal end of the slender carrier and is connected to one end of the support member. The distal end head 3 has a hollow channel that runs through axially, and the endoscope 4 can pass through the hollow channel in a mating manner and be fixed to the distal end head 3. Specifically, the distal end head 3 is made of a flexible material, such as a relatively soft material like silicone or polyurethane; the length of the distal end head 3 is preferably 5 mm to 20 mm; when the endoscope 4 is inserted into the hollow channel, it is connected to the wall of the hollow channel with an interference fit, so that the distal end head 3 can tightly wrap and fix on the outer surface of the endoscope 4, thus forming a smooth transition section between the endoscope 4 and the ablation device. And during the process of the endoscope 4 entering the human body, it can fix the electric field ablation device on the outside of the endoscope 4 to avoid damage to the tissues in the digestive tract. Specifically arranged, the distal end head 3 is in the shape of a frustum with a smaller front and a larger rear, and it is coaxially fixedly provided on the distal end of the base rod 1, and the transverse dimension of its hollow channel is slightly smaller than the transverse dimension of the endoscope channel 1a.

[0068] The following will separately elaborate on the preferred embodiments of the present invention in conjunction with the attached 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.

[0069] In this article, "proximal" and "distal" are defined based on the distance between the ablation main body 2 of the electric field ablation device and the operator after the ablation main body 2 of the electric field ablation device is inserted into the human digestive tract. Specifically, the "distal end" refers to the end away from the operator, and is also called the "front end"; the "proximal end" refers to the end close to the operator, and is also called the "rear end".

[0070] Embodiment 1

[0071] Refer to Figures 1 to 11 the shown electric field ablation device and ablation system. Among them, the slender carrier includes a base rod 1, the support member is sleeved on the circumferential outside of the base rod 1, and the endoscope channel 1a is provided on the above-mentioned base rod 1. Specifically arranged, the center line of the endoscope channel 1a extends collinearly with the axis line of the base rod 1. That is to say, the endoscope channel 1a is located at the central position of the base rod 1. When the electric field ablation device is sleeved on the endoscope 4, the endoscope 4 is basically in the middle position, and it has no negative impact during the process of the electric field ablation device entering and exiting the human digestive tract and during the process of the electric field ablation device performing ablation treatment on the digestive tract tissues.

[0072] In this embodiment, the support member is a balloon 21 having a balloon cavity. The balloon 21 is fixedly sleeved on the base rod 1. The electrode 221 is disposed on the outer surface of the balloon 21. At least a part of the base rod 1 is inserted into the balloon cavity. A liquid flow channel 1b is provided on the base rod 1, and a plurality of through holes 1d are further provided on the base rod 1. The through holes 1d communicate the balloon cavity with the liquid flow channel 1b, and the endoscope channel 1a is not communicated with the above-mentioned liquid flow channel 1b. By introducing liquid into the liquid flow channel 1b, the liquid can enter the balloon cavity through the liquid flow channel 1b and the through holes 1d, so that the balloon 21 is filled with liquid and expands, thereby increasing the lateral dimension of the ablation body 2 and converting it to the first state; conversely, after the liquid in the balloon cavity enters the liquid flow channel 1b through the through holes 1d and is discharged outwards, the balloon 21 is released and shrinks, so that the lateral dimension of the ablation body 2 decreases and converts to the second state.

[0073] When the electric field ablation device is sleeved on the endoscope 4 and used together, as Figure 3 shown, in the initial state, no liquid is introduced into the balloon 21, and the ablation body 2 is in the second state and has a smaller lateral dimension, so that the electric field ablation device and the endoscope 4 can be conveniently inserted into the human digestive tract; when the ablation body 2 reaches the position to be treated in the digestive tract, the operator injects liquid into the liquid flow channel 1b at the proximal end of the slender carrier, and the liquid enters the balloon cavity through the through holes 1d, causing the balloon 21 to be filled and expanded, so that the ablation body 2 is converted to the first state, as Figure 1 , Figure 2 , and Figure 5 shown. The lateral dimension of the ablation body 2 increases, and the electrode 221 on the outer peripheral part of the balloon 21 can be closely attached to the tissue of the digestive tract, thereby realizing the ablation treatment of the digestive tract. When facing digestive tracts with different diameters, only by controlling the volume of the liquid filled into the balloon cavity, the expansion state of the balloon 21 can be adjusted, so that the ablation body 2 has different lateral dimensions, thereby enabling the electrode 221 on the outer peripheral part of the balloon 21 to be closely attached to the tissue and achieving an accurate ablation effect.

[0074] When it is necessary to withdraw the electric field ablation device and the endoscope 4 from the human digestive tract after the treatment is completed, liquid can be pumped out of the liquid flow channel 1b so that the liquid in the balloon cavity is discharged, and the balloon 21 shrinks, reducing the lateral dimension of the ablation body 2, thereby facilitating its removal from the digestive tract. In the second state, the lateral dimension of the ablation body 2 is significantly reduced compared to that in the first state, enabling it to easily enter or exit the human digestive tract and pass through various channels of the digestive tract, thus facilitating the doctor's surgical operation and reducing the patient's pain; the balloon 21 has a soft texture and can fit more closely to the tissues of the human digestive tract. At the same time, by injecting or discharging liquid to control the expansion and contraction of the balloon 21, the operation is very convenient, and a more precise ablation treatment effect can be obtained; during the process of the ablation body 2 entering the human digestive tract, the distal end 41 of the endoscope can be located in front of the ablation body 2, making it more convenient for the doctor to clearly observe the internal conditions of the human digestive tract during the surgical operation.

[0075] Specifically, a guide wire channel 1e can also be added on the basis of the Figure 5 shown electric field ablation system, as Figure 6 shown. The guide wire channel 1e is provided on the base rod 1 and is not connected to the above-mentioned liquid flow channel 1b and the endoscope channel 1a. Through this guide wire channel 1e, external instruments can be inserted in front of the ablation body 2 to perform interventional treatment on the digestive tract tissues.

[0076] In this embodiment, the balloon 21 can be made of high molecular materials such as polyurethane, Pebax, silica gel, PA, etc. through a blowing process. When specifically manufacturing the balloon 21, heat setting can be performed after blow molding, so that the balloon 21 is divided into a main body part located in the center and a plurality of wing parts located outside the main body part, so that the ablation body 2 can be switched between the first state and the second state by the opening or folding of the wing parts relative to the main body part. In this way, during the process of the balloon 21 expanding when filled with liquid and contracting when discharging liquid, the elastic deformation amount of the circumferential side walls of the balloon 21 is relatively small, and the hard electrodes 221 fixed on the outer circumferential part of the balloon 21 are also less likely to fall off.

[0077] See Figure 1As shown, in this embodiment, all the electrodes 221 of the electrode assembly 22 are spaced apart circumferentially on the balloon 21. The electrode assembly 22 further includes a base 222, which is fixedly connected to the surface of the balloon 21. The electrodes 221 are fixedly arranged on the base 222. The base 222 is arranged to be flexibly deformable so as to deform correspondingly with the expansion and contraction of the balloon 21, such that the electrodes 221 are always fixedly attached to the outer circumferential portion of the balloon 21. Specifically, the base 222 is adhesively fixed to the surface of the balloon 21. Specifically, medical glues such as epoxy resin, UV curable glue, and acrylic resin glue can be used to bond the base 222 and the balloon 21. The base 222 is made of an insulating material, which can specifically be materials such as polyimide or polyethylene terephthalate; the electrodes 221 are metal electrodes, and the material of the metal electrodes can be conductive materials such as copper, silver, platinum, and stainless steel; the electrodes 221 can be formed on the base 222 by means of etching, pasting, plating, etc. Thus, a flexible electrode assembly 22 is obtained. The electrodes 221 can be in a strip shape as shown in Figure 1 , Figure 7 shown, or can be in the shape as shown in Figure 8 shown, or can be made into other shapes according to needs.

[0078] There are multiple groups of the bases 222 spaced apart circumferentially. Electrodes 221 are arranged on each group of the bases 222, such that all the electrodes 221 are evenly spaced on the outer circumferential portion of the balloon 21. The base 222 has a base portion 222a and two extension portions 222b located on both sides of the base portion 222a. The electrode 21 is arranged on the base portion 222a. The extension portions 222b extend away from the base portion 222a to the end of the balloon 21 and are fixedly connected to the base rod 1. The size of the base portion 222a is slightly larger than the size of the electrode 221 to facilitate fixing the electrode 221; the width of the extension portions 222b is smaller than the size of the base portion 222a. By respectively fixing the two extension portions 222b to the base rod 1, the risk that the electrode assembly 22 falls off during the expansion and contraction of the balloon 21 and remains in the human digestive tract can be effectively avoided, and it is also beneficial to arrange and install the electrode assembly 22, such that the multiple electrodes 221 can be evenly spaced on the outer circumferential portion of the balloon 21.

[0079] On the basis of the structure shown in Figure 1 , all the bases 222 can also be joined together to form an integral base in a mesh structure, as shown in Figure 7As shown. Specifically, the integral base of the mesh structure can be obtained by integral molding or by connecting multiple bases 222 to each other. The integral base is wrapped around the outer peripheral part of the balloon 21, and its two ends are fixedly connected to the base rod 1 respectively. By using the integral base of the mesh structure, on the one hand, it can significantly increase the overall strength of the ablation body 2 and extend the service life; on the other hand, it reduces the risk of unevenness or debonding that may occur during the production or use of the strip electrodes, and can make the multiple electrodes 221 more evenly distributed on the outer peripheral part of the balloon 21, reducing the production difficulty. The integral base with a mesh structure formed by hollowing out here also makes the base have a certain flexibility while ensuring the overall connection strength.

[0080] The electrode assembly 22 further includes a wire 223, and the wire 223 is connected to the electrode 221. A wire channel 1c for the wire 223 to pass through is provided on the base rod 1. The wire channel 1c is not communicated with the aforementioned liquid flow channel 1b and the endoscope channel 1a. After one end of the wire 223 is connected to the electrode 221, the other end of the wire 223 passes through the wire channel 1c and exposes outside the base rod 1 for connection with an external energy device 7 for generating electric field energy.

[0081] When specifically setting, as Figure 9 shown, the wire channel 1c and the liquid flow channel 1b are located on the same side of the endoscope channel 1a, and the wire channel 1c and the liquid flow channel 1b are arranged at intervals along the radial direction of the base rod 1. When setting the base rod 1, it only needs to be ensured that the part of the distal end of the base rod 1 for connecting the balloon 21 is a complete cylindrical rod 11 with a hollow cavity for the endoscope 4 to axially pass through, and the other rod segments can be set as arc-shaped rods 12, which makes the length of the endoscope channel 1a not too long, so that the endoscope 4 can be conveniently inserted into the endoscope channel 1a correspondingly, and at the same time makes the processing of the base rod 1 more convenient and the process simpler. When adopting the above structure, the arc-shaped groove 121 on the arc-shaped rod 12 can also position the endoscope wire body 42, so that the endoscope 4 can enter and exit the human digestive tract coaxially and synchronously with the base rod 1.

[0082] Embodiment 2

[0083] See Figures 10 to 15As shown, in this embodiment, the slender carrier includes a first rod 5 and a second rod 6 that are slidably connected along the axial direction. The support member is connected between the first rod 5 and the second rod 6, and when the first rod 5 and the second rod 6 move relative to each other along the axial direction, the ablation body 2 is caused to switch between a first state and a second state. Specifically, the first rod 5 has a first proximal end and a first distal end, the second rod 6 has a second proximal end and a second distal end, the first rod 5 and the second rod 6 are slidably sleeved, and the outer diameter of the slender carrier depends on the outer diameter of the rod located on the outside of the first rod 5 and the second rod 6; one end of the support member is fixedly connected to the first distal end, and the other end of the support member is fixedly connected to the second distal end. When the distance between the first distal end and the second distal end increases, the ablation body 2 switches from the first state to the second state.

[0084] In this embodiment, the support member is a metal stent 23 that can expand and contract. The metal stent 23 is sleeved on the circumferential outside of the first rod 5 and the second rod 6, and all the electrodes 24 are arranged on the surface of the support member and are spaced apart in the circumferential direction of the metal stent 23. Specifically, the metal stent 23 is made of a shape memory material. When the metal stent 23 is located in the human digestive tract tissue, if no external force is applied, the metal stent 23 can expand by means of temperature-induced phase change and automatically return to the maximum diameter state. Therefore, when the doctor operates the electric field ablation device, only when inserting it into the human tissue or withdrawing it from the human tissue, driving the first rod 5 and the second rod 6 to move relative to each other so that the first distal end and the second distal end move away from each other, and making the metal stent 23 contract can make the ablation body 2 be in the second state; and when the ablation body 2 is inserted into the position to be treated in the human digestive tract, the metal stent 23 can automatically return to the maximum diameter state and make the ablation body 2 switch to the first state.

[0085] The shape memory material used to make the metal stent 23 can be a nickel-titanium alloy or the like. The maximum diameter state of the metal stent 23 is the thermally set shape of this shape memory alloy material. For example, for a nickel-titanium alloy, its thermally set temperature is usually 500 degrees Celsius. The metal stent 23 can be made by laser cutting a nickel-titanium tube or by weaving nickel-titanium wires. The shape memory material used to make the metal stent 23 can also be a shape memory polymer material, specifically a thermoplastic polyester elastomer material or the like. This type of material needs to be processed by special processes to have shape memory performance. Specifically arranged, the metal stent 23 includes a plurality of support rods 231. The plurality of support rods 231 are in the shape of long filaments, and the plurality of support rods 231 intersect with each other to form a net structure. When the first rod 5 and the second rod 6 slide axially relative to each other, it can make the two ends of the metal stent 23 approach each other relatively, so that the metal stent 23 expands laterally and converts to the first state, or it can make the two ends of the metal stent 23 move away from each other relatively, so that the metal stent 23 is axially pulled and contracted to convert to the second state.

[0086] When the metal stent 23 is made of a metal material such as a nickel-titanium alloy, due to its own conductivity, it is very difficult to control the electrodes on the metal stent 23 without insulation treatment. Therefore, an insulating layer (not shown in the figure) is also provided between the surface of the metal stent 23 and the electrodes. Here, the entire surface of the metal stent 23 is also wrapped with an insulating layer, making the entire metal stent 23 insulated. The material of this insulating layer can be a polymer material such as polytetrafluoroethylene or polyethylene, and is wrapped on the surface of the metal stent 23 by plating. The electrode 24 is fixedly arranged on the surface of the insulating layer.

[0087] In some embodiments, the electrode 24 is fixedly connected to the surface of the metal stent 23. The electrode 24 can be specifically arranged in a sheet shape, such as Figure 10 、 Figure 11 and Figure 13 shown circular sheet shape, which can achieve ablation at multiple positions; or such as Figure 12 、 Figure 14 shown strip shape, which can achieve a larger range of ablation within a single electrode and reduce the overall complexity of the device; it can also be made into other shapes according to actual needs. The electrode 24 can be specifically cut from conductive materials such as copper, silver, platinum, gold, and stainless steel. The electrode 24 can be fixed on the surface of the metal stent 23 by gluing, and the glue for bonding can be selected from medical glues such as epoxy resin, UV curable glue, and acrylic resin glue.

[0088] In some embodiments, at least two support rods 231 in the metal stent 23 are joined and extend in different directions to form a net structure. A joint portion 232 is formed at the position where the at least two support rods 231 are joined, such as Figure 13 、Figure 14 As shown, the electrode 24 is fixedly connected to the joint portion 232. In this way, a relatively large area is formed for adhesively fixing the electrode 24, so that the electrode 24 can be stably attached to the surface of the metal stent 23. During the expansion and contraction of the metal stent 23, the relative movement and deformation between the plurality of support rods 231 will not cause the electrode 24 adhesively fixed at the joint portion 232 to fall off. Of course, the metal stent 23 can also be set to other non-mesh structures, such as a wavy structure or a diamond structure, etc., and the electrode 24 is connected to the plurality of support rods 231 at the same time, and it can also be firmly attached to the metal stent 23.

[0089] In some other embodiments, the electrode 24 can also be fixedly arranged outside the metal stent 23 and attached to the surface of the metal stent 23 in other ways. Such as Figure 15 In the shown embodiment, the electrode assembly 22 further includes electrode support rods 25, which are connected between the first distal end portion and the second distal end portion, and the electrode 24 is fixed on the electrode support rods. The electrode support rods 25 have a plurality of them circumferentially spaced outside the metal stent 23, and each electrode support rod 25 can be arranged to be flexibly deformed. The material of the electrode support rod 25 can be a polymer material such as nylon, polyimide, polyethylene, etc., and it can conform to the contour of the metal stent 23. The two ends of each electrode support rod 25 can be fixedly attached to the first distal end portion and the second distal end portion respectively by adhesion. When the first rod 5 and the second rod 6 move, each electrode support rod 25 also moves with the first rod 5 and the second rod 6. During the expansion and contraction of the metal stent 23, each electrode support rod 25 can remain attached to the surface of the metal stent 23, so that the electrode 24 thereon is attached and fixed to the surface of the metal stent 23. The electrode 24 can be specifically set as a circular ring and is installed on the electrode support rod 25 by sleeving. Along the length direction of the electrode support rod 25, one group or two or more groups spaced from each other can be set for the electrode 25.

[0090] In the electric field ablation device provided in this embodiment, the endoscope channel 1a is opened on the first rod 5, the second rod 6 is sleeved on the first rod 5 and exposes the first distal end portion, the second distal end portion is located behind the first distal end portion, the metal stent 23 is sleeved on the rod segment of the first rod 5 that passes through the front of the second rod 6, the front end portion is connected to the first distal end portion, and its rear end portion is connected to the second distal end portion. The end tip 3 is fixedly connected to the first distal end portion.

[0091] When the electric field ablation device provided in this embodiment is sleeved on the endoscope 4 and used together, such as Figures 10 to 13As shown, when entering or exiting the human digestive tract, the operator can first drive the first distal end and the second distal end away from each other to contract the metal stent 23, so that the ablation body 2 is converted to the second state. In this way, the transverse dimension of the ablation body 2 is reduced, enabling it to enter or exit the human body conveniently and pass through various cavities of the digestive tract, thus facilitating the doctor's surgical operation and reducing the patient's pain. When the ablation body 2 extends to the position to be treated in the human digestive tract, the first distal end and the second distal end are driven to approach each other to expand the metal stent 23, so that the transverse dimension of the ablation body 2 increases and it is converted to the first state. The multiple electrodes 24 located on the surface of the metal stent 23 can closely adhere 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, by only driving the first rod 5 and the second rod 6 to slide axially relative to each other, the metal stent 23 can be deformed accordingly, so that the electrodes 24 on the surface of the metal stent 23 can closely adhere to the tissue, achieving an accurate ablation effect.

[0092] Embodiment 3

[0093] See Figures 16 to 19 As shown, the electric field ablation device and the electric field ablation system provided in this embodiment are mainly different from those in Embodiment 2 in the structure of the ablation body 2.

[0094] In this embodiment, the support member is a metal strip 26, and the metal strip 26 is connected between the first distal end 5A and the second distal end 6A. Specifically, the second rod 6 is slidably sleeved on the first rod 5 and exposes the first distal end 5A. The metal strip 26 can be spirally wound around the outer circumference of the first rod 5. One end of it is fixedly connected to the first distal end 5A and the other end is fixedly connected to the second distal end 6A. The end tip 3 is arranged on the first distal end 5A. Electrodes (not shown in the figure) are fixedly arranged on the metal strip 26, and the electrodes expose outward from the surface of the metal strip 26 facing away from the first rod 5.

[0095] In the first state, the metal strip 26 has an arched portion that arches outward away from the first rod 5. The arched portion has one on one side of the first rod 5 or multiple ones distributed on different sides of the first rod 5. The distance from the axis of the first rod 5 to the arched portion is the transverse dimension of the ablation body 2 in the first state. As Figure 18 shown, by driving the first rod 5 and the second rod 6 to move axially relative to each other, the metal strip 26 can be axially stretched or released, so that the outer diameter of the spiral structure of the metal strip 26 on the outer circumference of the first rod 5 can be increased or decreased, that is, the distance from the arched portion to the axis of the first rod 5 is different, and further the ablation body 2 can be converted between the first state and the second state.

[0096] The metal strip 26 is specifically made of a shape memory alloy material. The maximum lateral dimension of the metal strip 26 is the thermally set shape of the shape memory alloy, and the thermally set temperature is usually about 500 degrees Celsius. In this embodiment, a nickel-titanium alloy material is used. The metal strip 26 is obtained by forming a nickel-titanium alloy sheet through a specific mold. Before being formed, the metal strip 26 is in a long strip shape, and its width is preferably 1 mm to 10 mm, and its thickness is preferably 0.1 mm to 1 mm. When forming, the long strip-shaped nickel-titanium alloy sheet can be wrapped around the outer peripheral part of a cylindrical forming mold 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 metal strip 26. In human tissues, if no external force is applied, the metal strip 26 can automatically return to the state of the maximum diameter by means of temperature-induced phase change, that is, it can automatically return to the first state.

[0097] When specifically arranged, the electrode assembly further includes an insulating layer, and the insulating layer is fixedly arranged on the metal strip 26, and the electrodes are fixedly arranged on the insulating layer. Specifically, the insulating layer is strip-shaped, and its width, length and the metal strip 26 are basically the same; the insulating layer is fixedly connected to one side surface of the metal strip 26 along the length direction, and all the electrodes are evenly spaced in the length direction of the insulating layer. The material of the insulating layer can be polyimide or polyethylene terephthalate and other materials with high breakdown voltage resistance. The insulating layer is fixedly bonded to the metal strip 26 through glue, and an adhesive layer is formed between the insulating layer and the metal strip 26. The electrode assembly as a whole is flexible and can deform accordingly with the deformation of the metal strip 26, so that the positions of the electrodes on the surface of the metal strip 26 are relatively fixed.

[0098] The electrodes are specifically metal electrodes, and the material of the metal electrodes can be conductive materials such as copper, silver, platinum, gold, stainless steel, etc. The electrodes can be formed on the insulating layer by etching, pasting, or plating; the number of electrodes is specifically 4 to 48, and can be designed according to the maximum lateral dimension of the metal strip 26; the width of the electrodes is preferably 0.1 mm to 5 mm.

[0099] In this electric field ablation device, the endoscope channel 1a is arranged on the first rod 5, and the center line of the endoscope channel 1a is preferably arranged to be collinear with the axis of the first rod 5, so that the endoscope 4 can be located at the central position of the ablation main body 2. When specifically arranging the first rod 5 and the second rod 6, the part near the distal end can be set as a complete hollow cylindrical structure, and other parts can be set as arc-shaped rod structures, which is more convenient for the endoscope 4 to pass through the endoscope channel 1a and is beneficial to reducing the assembly and manufacturing difficulty.

[0100] When the electric field ablation device provided in this embodiment is sleeved on the endoscope 4 for common use, as Figure 19As shown, when entering or exiting the human digestive tract, the operator can first drive the first distal end 5A and the second distal end 6A to move away from each other, so that the metal strip 26 is pulled in the length direction to reduce the transverse dimension, and the ablation body 2 is converted to the second state, enabling it to enter the human digestive tract or exit from the human digestive tract conveniently and pass through various cavities of the digestive tract easily, thus facilitating the doctor's surgical operation and reducing the patient's pain. When the ablation body 2 extends to the position to be treated in the human digestive tract, drive the first distal end 5A and the second distal end 6A to approach each other, so that the metal strip 26 expands and its transverse dimension becomes larger, and the ablation body 2 is converted to the first state, enabling the multiple electrodes located on the surface of the metal strip 26 to closely adhere 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 5 and the second rod 6 to slide axially relative to each other, the metal strip 26 can be deformed accordingly, enabling the electrodes on the surface of the metal strip 26 to closely adhere to the tissue, achieving an accurate ablation effect, and being relatively convenient for operation and adjustment.

[0101] 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.

[0102] 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 contained in other published documents, the definitions used herein shall prevail.

[0103] As shown in this specification and the claims, the terms "comprising" and "including" only indicate the inclusion of the steps and elements that have been clearly identified, and these steps and elements do not constitute an exclusive list. The method or device may also include other steps or elements.

[0104] It can be further understood that "a plurality of" in the present disclosure means two or more, and other quantifiers are similar. "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.

[0105] It can be further understood that the terms "first", "second", etc. are used to describe various information, but such information should not be limited to these terms. These terms are only used to distinguish information of the same type from each other, and do not represent a specific order or degree of importance. In fact, expressions such as "first" and "second" 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.

[0106] The above embodiments are only for illustrating 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 should not be used to limit the protection scope of the present invention. All 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: An elongated carrier; An ablation body, the ablation body including a support member and an electrode assembly, the support member being disposed on the elongated carrier, the electrode assembly including a plurality of electrodes, all of the electrodes being spaced apart and distributed outside the support member, the support member being deformably disposed such that the ablation body has a first state with a larger lateral dimension and a second state with a smaller lateral dimension; Wherein, an endoscope channel axially penetrating through the elongated carrier is provided on the elongated carrier for an endoscope to pass through.

2. The electric field ablation device for the digestive tract according to claim 1, wherein: The electric field ablation device further includes a distal end head, the distal end head being fixedly provided on the distal end of the elongated carrier and connected to one end of the support member, the distal end head having a hollow channel axially penetrating through, and the endoscope can pass through the hollow channel in a mating manner and be fixedly engaged with the distal end head.

3. The electric field ablation device for the digestive tract according to claim 2, characterized in that: The distal end head is made of a flexible material, and when the endoscope is inserted into the hollow channel, it is connected to the inner wall of the hollow channel in an interference fit manner.

4. The electric field ablation device for the digestive tract according to claim 1, wherein: The elongated carrier includes a base rod, the support member is sleeved on the circumferential outer side of the base rod, and the endoscope channel is provided on the base rod.

5. The electric field ablation device for the digestive tract according to claim 4, characterized in that: The center line of the endoscope channel extends collinearly with the axis line of the base rod.

6. The electric field ablation device for the digestive tract according to claim 4, characterized in that: The support member is a balloon having a balloon cavity, the balloon is fixedly sleeved on the base rod, and at least a part of the base rod is inserted into the balloon cavity. Wherein, a liquid flow channel is provided on the base rod, and a through hole is further opened on the base rod, the through hole communicating the balloon cavity with the liquid flow channel, and the endoscope channel is not communicated with the liquid flow channel.

7. The electric field ablation device for the digestive tract according to claim 6, characterized in that: All of the electrodes are spaced apart in the circumferential direction of the balloon. Wherein, the electrode assembly further includes a base, the base is fixedly connected to the surface of the balloon, the base is deformably disposed in a flexible manner to deform correspondingly with the expansion and contraction of the balloon, and the electrode is fixedly provided on the base.

8. The electric field ablation device for the digestive tract according to claim 7, characterized in that: The base is adhesively fixed to the surface of the balloon; and / or, the electrode is formed on the base by etching, pasting, or plating.

9. The electric field ablation device for the digestive tract according to claim 7, characterized in that: The base has a base portion and two extension portions located on both sides of the base portion, the electrode is provided on the base portion, and the extension portions extend away from the base portion to the end of the balloon and are fixedly connected to the base rod; Wherein, there are multiple groups of the bases spaced apart in the circumferential direction, and multiple groups of the bases respectively connect the balloon and the base rod, or all of the bases are joined together to form an integral base with a mesh structure.

10. The electric field ablation device for the digestive tract according to claim 6, characterized in that: The electrode assembly further includes a wire, the wire is connected to the electrode, and a wire channel for the wire to pass through is further provided on the base rod, and the wire channel, the liquid flow channel, and the endoscope channel are not communicated with each other.

11. The electric field ablation device for the digestive tract according to claim 10, wherein: The wire channel and the liquid flow channel are located on the same side of the endoscope channel, and the wire channel and the liquid flow channel are spaced apart in the radial direction of the base rod.

12. The electric field ablation device for the digestive tract according to claim 1, wherein: The elongate carrier includes a first rod and a second rod that are axially slidably connected, and the support is connected between the first rod and the second rod. When the first rod and the second rod move axially relative to each other, the ablation body is caused to switch between the first state and the second state.

13. The electric field ablation device for the digestive tract according to claim 12, characterized in that: The first rod has a first proximal end and a first distal end, and the second rod has a second proximal end and a second distal end. The first rod and the second rod are sleeved to axially slide relative to each other. One end of the support is fixedly connected to the first distal end, and the other end of the support is fixedly connected to the second distal end. When the distance between the first distal end and the second distal end increases, the ablation body switches from the first state to the second state.

14. The electric field ablation device for the digestive tract according to claim 13, wherein: The support is a metal stent capable of expanding and contracting. The metal stent is sleeved on the circumferential outer side of the first rod. The front end of the metal stent is connected to the first distal end, and the proximal end of the metal stent is connected to the second distal end. All the electrodes are circumferentially spaced apart on the metal stent. Among them, the endoscope channel is provided on the first rod.

15. The electric field ablation device for the digestive tract according to claim 14, characterized in that: The electrodes are fixedly connected to the surface of the metal stent. Alternatively, the electrode assembly further includes electrode support rods. The electrode support rods are connected between the first distal end and the second distal end, and the electrodes are fixed to the electrode support rods. Among them, there are multiple electrode support rods circumferentially spaced apart on the outer side of the metal stent. Each electrode support rod is arranged to be flexibly deformable so as to be able to fit on the surface of the metal stent.

16. The electric field ablation device for the digestive tract according to claim 14, characterized in that: The metal stent includes multiple support rods. The multiple support rods are cross - arranged to form a net structure. Among them, at least two support rods are joined and extend in different directions to form the net structure. A joint is formed at the position where the at least two support rods are joined, and the electrodes are fixedly connected to the joint.

17. The electric field ablation device for the digestive tract according to claim 13, characterized in that: The support is a metal strip. The metal strip can be spirally wound around the circumferential outer side of the first rod. The electrodes are fixedly arranged on the metal strip, and the electrodes expose outward from the surface of the metal strip facing away from the first rod. Among them, the endoscope channel is provided on the first rod.

18. The electric field ablation device for the digestive tract according to claim 17, wherein: In the first state, the metal strip has an arched portion that arches outward away from the first rod. The arched portion has one on one side of the first rod or multiple that are respectively arranged on different sides of the first rod.

19. An electric field ablation system for the digestive tract, characterized in that: The electric field ablation system includes the electric field ablation device for the digestive tract according to any one of claims 1 to 18. The electric field ablation system further includes an endoscope. The endoscope is inserted into the endoscope channel, and the distal end of the endoscope exposes in front of the elongate carrier.

20. The electric field ablation system for the digestive tract according to claim 19, wherein: The electric field ablation system further includes an energy device for generating electric field energy. The energy device is connected to the electrodes through wires.

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