A device for ablation therapy of the digestive tract and a system comprising the same

Abstract

A device for ablation treatment of a digestive tract and a system comprising the same, comprising: an inner tube; an outer tube sleeved outside the inner tube; a rotating tube, the rotating tube being rotatably sleeved outside the inner tube; an electrode film having a contracted state of being radially reduced and an expanded state of being radially increased, the electrode film having an inner electrode film end and an outer electrode film end in a winding direction of the electrode film, the outer electrode film end being fixedly arranged with the outer tube, and the inner electrode film end being fixedly arranged with the rotating tube; and an expandable member having a contracted state of being radially reduced and an expanded state of being radially increased, the expandable member being completely located on one side of the inner tube; when the expandable member is in the contracted state, the electrode film is also in the contracted state, the expandable member is located between the outermost electrode film and the next outermost electrode film, and each layer of electrode film inside the next outermost electrode film is spirally wound on the rotating tube; when the expandable member is in the expanded state, the electrode film is expanded to the expanded state by the expandable member.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically to a device and system comprising ablation therapy of the digestive tract. Background Technology

[0002] In the prior art, CN104546118B discloses an ablation device, including an expansion member and an ablation structure disposed outside the expansion member. The ablation structure has a fixed end disposed inside and a free end disposed outside. When the expansion member expands, the ablation structure expands accordingly. However, since its free end is disposed outside, when the ablation device moves inside the human body or when ablation is performed on a target location, the free end is prone to deflection, affecting the effectiveness of the device.

[0003] Therefore, how to design a device that is easy to operate and highly reliable for ablation treatment of the digestive tract is a goal explored by those skilled in the art. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide an apparatus for ablation treatment of the digestive tract and a system including the same.

[0005] To solve the above technical problems, the technical solution adopted in the first aspect of the present invention is as follows: A device for ablation therapy of the digestive tract, comprising: A slender inner tube; A slender outer tube is fitted over the inner tube; A rotating tube, wherein the rotating tube is rotatably sleeved outside the inner tube; An electrode film has a radially decreasing contraction state and a radially increasing expansion state. In the winding direction of the electrode film, the electrode film has an inner end and an outer end. The outer end is fixedly disposed with the outer tube, and the inner end is fixedly disposed with the rotating tube. An expandable member has a radially decreasing contracted state and a radially increasing expanded state, and the expandable member is biased to one side of the inner tube; when the expandable member is in the contracted state, the electrode film is also in the contracted state, and the expandable member is located between the outermost electrode film and the second outermost electrode film, and each layer of the electrode film inside the second outermost electrode film is spirally wound on the rotating tube; when the expandable member is in the expanded state, the electrode film is stretched open by the expandable member and is in the expanded state.

[0006] In some embodiments, the outer tube has an opening extending in the front-rear direction, and the outermost electrode film passes through the opening.

[0007] In some embodiments, the inner wall of the outer tube forms a cavity, and the secondary outer electrode film and each of the electrode films inside the secondary outer electrode film are located within the cavity.

[0008] In some embodiments, a limiting member is provided between the inner tube and the outer tube, the limiting member being used to limit the movement of the rotating tube relative to the outer tube in the front-rear direction. In some embodiments, the outer tube is provided with a front limiting member and a rear limiting member, and the rotating tube is located between the front limiting member and the rear limiting member.

[0009] In some embodiments, one of the outer tube and the rotating tube is provided with a circumferentially extending limiting member, and the other of the outer tube and the rotating tube is provided with a limiting groove that cooperates with and engages with the limiting member.

[0010] In some embodiments, the expandable member is a balloon.

[0011] In some embodiments, the electrode membrane is an elastic electrode membrane, the elasticity causing the electrode membrane to tend to transition from an expanded state to a contracted state.

[0012] In some embodiments, the electrode membrane includes an electrode membrane body and an elastic sheet adhered to the electrode membrane body.

[0013] In some embodiments, the outer tube has two ends extending in a front-rear direction, and the outer end of the electrode film is fixedly connected to one of the two ends.

[0014] In some embodiments, the other end of the two said ends is used to engage with the outermost electrode film when the electrode film moves relative to the opening.

[0015] In some embodiments, the outer tube has a first cross-section extending radially, and the inner wall of the outer tube surrounds a second cross-section extending radially, the second cross-section not protruding from the first cross-section.

[0016] In some embodiments, when the expandable member is in a contracted state, the radially extending cross section of the electrode film does not protrude beyond the first cross section.

[0017] To solve the above technical problems, the second aspect of the present invention adopts the following technical solution: A system for ablation therapy of the digestive tract, comprising the apparatus for ablation therapy of the digestive tract as described above, and further comprising: A signal generator configured to generate an electrical signal for treatment and electrically connected to the electrodes of the electrode membrane; A pressure source connected to a medium pipe, the pressure source being used to inject or draw medium into the expandable member through the medium pipe; An operating handle is attached to the proximal end of the outer tube.

[0018] To solve the above technical problems, the technical solution adopted in the third aspect of the present invention is as follows: An example of an apparatus for ablation treatment of the digestive tract includes: A slender inner tube; A slender outer tube is fitted over the inner tube; An electrode membrane has a radially shrinking contraction state and a radially expanding expansion state. In the winding direction of the electrode membrane, the electrode membrane has an inner end and an outer end. The outer end is fixedly disposed with the outer tube. A section of the electrode membrane containing the inner end is wound on the inner tube, and the inner end is freely disposed circumferentially relative to the inner tube. An expandable member has a radially decreasing contracted state and a radially increasing expanded state, the expandable member being completely located on one side of the inner tube; when the expandable member is in the contracted state, the electrode film is also in the contracted state, the expandable member is located between the outermost electrode film and the second outermost electrode film, and each layer of the electrode film inside the second outermost electrode film is spirally wound on the inner tube; when the expandable member is in the expanded state, the electrode film is stretched open by the expandable member and is in the expanded state.

[0019] In some embodiments, the outer tube has an opening extending in the front-rear direction, and the outermost electrode film passes through the opening.

[0020] In some embodiments, the inner wall of the outer tube forms a cavity, and the secondary outer electrode film and each of the electrode films inside the secondary outer electrode film are located within the cavity.

[0021] In some embodiments, a limiting member is provided between the inner tube and the outer tube, the limiting member being used to limit the movement of the inner end of the electrode film relative to the outer tube in the front-back direction.

[0022] In some embodiments, the outer tube is provided with a front limiting member and a rear limiting member, and the inner end of the electrode film is located between the front limiting member and the rear limiting member.

[0023] In some embodiments, the expandable member is a balloon.

[0024] In some embodiments, the electrode membrane is an elastic electrode membrane, the elasticity causing the electrode membrane to tend to transition from an expanded state to a contracted state.

[0025] In some embodiments, the electrode membrane includes an electrode membrane body and an elastic sheet adhered to the electrode membrane body.

[0026] In some embodiments, the outer tube has two ends extending in a front-rear direction, and the outer end of the electrode film is fixedly connected to one of the two ends.

[0027] In some embodiments, the other end of the two said ends is used to engage with the outermost electrode film when the electrode film moves relative to the opening.

[0028] In some embodiments, the outer tube has a first cross-section extending radially, and the inner wall of the outer tube surrounds a second cross-section extending radially, the second cross-section not protruding from the first cross-section.

[0029] In some embodiments, when the expandable member is in a contracted state, the radially extending cross section of the electrode film does not protrude beyond the first cross section.

[0030] To solve the above technical problems, the technical solution adopted in the fourth aspect of the present invention is as follows: An example of an apparatus for ablation treatment of the digestive tract includes: A slender inner tube; A slender outer tube is fitted over the inner tube, and the inner tube is rotatably disposed relative to the outer tube; An electrode membrane has a radially shrinking contraction state and a radially expanding expansion state. In the winding direction of the electrode membrane, the electrode membrane has an inner end and an outer end. The outer end is fixedly disposed with the outer tube, and a section of the electrode membrane containing the inner end is wound on the inner tube. The inner end is fixedly disposed relative to the inner tube. An expandable member has a radially decreasing contracted state and a radially increasing expanded state, the expandable member being completely located on one side of the inner tube; when the expandable member is in the contracted state, the electrode film is also in the contracted state, the expandable member is located between the outermost electrode film and the second outermost electrode film, and each layer of the electrode film inside the second outermost electrode film is spirally wound on the inner tube; when the expandable member is in the expanded state, the electrode film is stretched open by the expandable member and is in the expanded state.

[0031] In some embodiments, the outer tube has an opening extending in the front-rear direction, and the outermost electrode film passes through the opening.

[0032] In some embodiments, the inner wall of the outer tube forms a cavity, and the secondary outer electrode film and each of the electrode films inside the secondary outer electrode film are located within the cavity.

[0033] In some embodiments, a limiting member is provided between the inner tube and the outer tube, the limiting member being used to limit the movement of the inner tube relative to the outer tube in the front-back direction.

[0034] In some embodiments, the outer tube is provided with a front limiting member and a rear limiting member, and the rotating tube is located between the front limiting member and the rear limiting member. In some embodiments, the expandable member is a balloon.

[0035] In some embodiments, the electrode membrane is an elastic electrode membrane, the elasticity causing the electrode membrane to tend to transition from an expanded state to a contracted state.

[0036] In some embodiments, the electrode membrane includes an electrode membrane body and an elastic sheet adhered to the electrode membrane body.

[0037] In some embodiments, the outer tube has two ends extending in a front-rear direction, and the outer end of the electrode film is fixedly connected to one of the two ends.

[0038] In some embodiments, the other end of the two said ends is used to engage with the outermost electrode film when the electrode film moves relative to the opening.

[0039] In some embodiments, the outer tube has a first cross-section extending radially, and the inner wall of the outer tube surrounds a second cross-section extending radially, the second cross-section not protruding from the first cross-section.

[0040] In some embodiments, when the expandable member is in a contracted state, the radially extending cross section of the electrode film does not protrude beyond the first cross section.

[0041] Due to the application of the above-mentioned technical solution, the present invention has the following advantages compared with the prior art: a. The device for ablation treatment of the digestive tract in this invention sets the outer end of the electrode membrane to be fixed to the outer tube and the inner end of the electrode membrane to be fixed to the rotating tube, and the rotating tube can rotate relative to the inner tube. On the one hand, it ensures the expansion function of the electrode membrane, and on the other hand, the device will not deviate during movement or ablation in the human body, which improves the user experience and ensures the ablation effect.

[0042] b. By setting the expandable component to be completely located on one side of the inner tube and nested between the outermost electrode film and the second outermost electrode film, only a single electrode film is located outside the expandable component during expansion, thus enabling the electrode film to expand passively and precisely. c. The nested storage method of expandable components can reduce the outer diameter of the device in the contracted state and improve the intervention effect. Attached Figure Description

[0043] Figure 1 This is a three-dimensional schematic diagram of the device for ablation treatment of the digestive tract according to Embodiments 1-3 of the present invention, in which the expandable component is in an expanded state; Figure 2 This is a front view of the device for ablation treatment of the digestive tract according to Embodiments 1-3 of the present invention, in which the expandable component is in an expanded state; Figure 3 As shown in Embodiment 1 of the present invention Figure 2 A cross-sectional view along the AA direction; Figure 4 As shown in Embodiment 1 of the present invention Figure 2 A cross-sectional view along the BB direction; Figure 5 for Figure 4 Enlarged view of section C; Figure 6 This is a three-dimensional schematic diagram of the device for ablation treatment of the digestive tract according to embodiments 1-3 of the present invention, in which the expandable component is in a contracted state; Figure 7 This is a front view of the device for ablation treatment of the digestive tract according to Embodiments 1-3 of the present invention, in which the expandable component is in a contracted state; Figure 8 As shown in Embodiment 1 of the present invention Figure 7 A cross-sectional view along the DD direction; Figure 9 As shown in Embodiment 1 of the present invention Figure 7 A cross-sectional view along the EE direction; Figure 10 for Figure 9 Enlarged image; Figure 11 As shown in Embodiment 2 of the present invention Figure 2 A cross-sectional view along the AA direction; Figure 12 As shown in Embodiment 2 of the present invention Figure 2 A cross-sectional view along the BB direction; Figure 13 for Figure 12 Enlarged view of section F in the middle; Figure 14 As shown in Embodiment 2 of the present invention Figure 7 A cross-sectional view along the DD direction; Figure 15 As shown in Embodiment 2 of the present invention Figure 7 A cross-sectional view along the EE direction; Figure 16 for Figure 15 Enlarged image; Figure 17 As shown in Embodiment 3 of the present invention Figure 2 A cross-sectional view along the AA direction; Figure 18 As shown in Embodiment 3 of the present invention Figure 2 A cross-sectional view along the BB direction; Figure 19 for Figure 18 Enlarged view of section G in the middle; Figure 20 As shown in Embodiment 3 of the present invention Figure 7 A cross-sectional view along the DD direction; Figure 21 As shown in Embodiment 3 of the present invention Figure 7 A cross-sectional view along the EE direction; Figure 22 for Figure 21 Enlarged image; Icon labels: 1-Inner tube; 21-First conical tube; 211-First limiting wall; 22-Second conical tube; 221-Second limiting wall; 23-Connector; 231-Inner wall; 2311-End; 232-Cavity; 233-Opening; 3-Rotating tube; 4-Electrode membrane; 41-Inner end of electrode membrane; 42-Outer end of electrode membrane; 43-Outermost electrode membrane; 44-Second outermost electrode membrane; 5-Expandable component; 6-Dielectric tube; 7-Front limiting component; 8-Rear limiting component. Detailed Implementation

[0044] The present invention will be further described below with reference to embodiments. In the description of the present invention, the digestive tract refers to the oral cavity, esophagus, stomach, duodenum, small intestine, large intestine, anus, etc., and the term "proximal" refers to the end closer to the operator, while "distal" refers to the end farther from the operator, such as... Figure 2 As shown in the figure, the upper direction is the relative "far end" or "front", and the lower direction is the relative "proximal end" or "rear end". In the left and right directions, the direction closer to the inner tube is "inner", and the direction farther from the inner tube is "outer". The above definitions of directions are only for the convenience of describing the present invention and simplifying the description. They are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the present invention.

[0045] Example 1 like Figure 1-10As shown, the device for ablation treatment of the digestive tract in this embodiment includes a slender inner tube 1, a slender outer tube, a rotating tube 3, an electrode membrane 4, and an expandable member 5. Both the electrode membrane 4 and the expandable member 5 have a radially decreasing contraction state and a radially increasing expansion state.

[0046] The inner tube 1 is disposed inside the device in this embodiment and is used to pass through components such as guide wires.

[0047] The rotating tube 3 is rotatably sleeved outside the inner tube 1, and the rotating tube 3 can be rotated relative to the outer tube.

[0048] In the winding direction of the electrode film 4, the electrode film 4 has an inner end portion 41 and an outer end portion 42. Both the outer end portion 42 and the inner end portion 41 extend in the front-back direction. The outer end portion 42 is fixedly disposed with the outer tube, and the inner end portion 41 is fixedly disposed with the rotating tube 3. In this embodiment, the entire outer end portion 42 of the electrode film is fixedly connected with the outer tube, and the entire inner end portion 41 of the electrode film is fixedly connected with the rotating tube 3. In other embodiments, the front and rear portions of the outer end portion 42 of the electrode film can be fixedly connected with the outer tube, and the front and rear portions of the inner end portion 41 of the electrode film can be fixedly connected with the rotating tube 3.

[0049] In this embodiment, the electrode film 4 has an elastic force, which causes the electrode film to tend to transition from an expanded state to a contracted state. The elastic force of the electrode film 4 allows it to be wound in a spiral shape around the rotating tube 3. Specifically, the electrode film 4 includes an electrode film body and an elastic sheet attached to the electrode film body. When the expandable member 5 is in a contracted state, the elastic sheet provides the elastic force required for the electrode film 4 to be wound around the rotating tube 3. At least a portion of the electrode film body and the elastic sheet overlap and are fixedly connected in the winding direction. In this embodiment, all electrode film bodies are attached with elastic sheets. In other embodiments, it is not necessary for all electrode films 4 to have elastic sheets in the winding direction. Specifically, in one embodiment, the elastic sheet may have an inner end and an outer end in the winding direction, and the electrode film body may have an inner end and an outer end. In the winding direction, the inner end of the electrode film body and the inner end of the elastic sheet are overlapped. The inner end of the electrode film body and / or the inner end of the elastic sheet are fixedly connected to the rotating tube 3. In another embodiment, the elastic sheet can be configured to have an inner end and an outer end in the winding direction, and the electrode film body has an inner end and an outer end. In the winding direction, the inner end of the electrode film body is located between the inner end and the outer end of the elastic sheet, and the inner end of the elastic sheet is fixedly connected to the rotating tube 3.

[0050] The outer tube is fitted over the inner tube 1. Specifically, the outer tube includes a first tapered tube 21, a second tapered tube 22, and a connector 23, which are fixedly connected to each other.

[0051] The first conical tube 21, the connector 23, and the second conical tube 22 are all located at the distal end of the device in this embodiment. The three are arranged in sequence from far to near. The first conical tube 21 is a cone shape that is narrow at the front and wide at the back, and the second conical tube 22 is a cone shape that is wide at the front and narrow at the back, so as to facilitate the passage of the device in the human body.

[0052] The connector 23 has an inner wall 231, which surrounds and forms a cavity 232. The rotating tube 3 and part of the inner tube 1 are both disposed in the cavity 232. The outermost electrode membrane 44 and each of the inner electrode membranes 4 are located in the cavity. Specifically, the inner wall 231 is a circumferential inner wall formed by rotating around the axis of the inner tube 1. When the expandable member 5 is in a contracted state, the inner wall 231 confines at least part of the electrode membrane 4 in the cavity 232. The inner wall 231 forms a physical limit on the electrode membrane 4, preventing the electrode membrane 4 from loosening and lifting up in the contracted state and scraping the inner wall of the digestive tract, thus improving the safety of use. It also further reduces the outer diameter of the device and improves its ability to pass through narrow digestive tract lumens.

[0053] An opening 233 extending in the front-to-back direction is provided on the outer tube. The outermost electrode film 43 passes through the opening 233. The outer tube has two ends 2311 extending in the front-to-back direction, which surround the opening 233. The outer end 42 of the electrode film is fixedly connected to one of the ends 2311. The other end 2311 is used to abut against the outermost electrode film 43 when the electrode film 4 moves relative to the opening 233 to ensure that the electrode film 4 does not twist. The two ends 2311 are located between the first tapered tube 21 and the second tapered tube 22. The first tapered tube 21 has a radially extending first limiting wall 211, and the second tapered tube 22 has a radially extending second limiting wall 211. In the front-back direction, the two ends 2311 of the retaining wall 221 are located between the first retaining wall 211 and the second retaining wall 221. In this embodiment, the cross-sections of the first retaining wall 211 and the second retaining wall 221 form a first cross-section, and the inner wall 231 of the outer tube surrounds and forms a second cross-section extending radially. The second cross-section does not protrude from the first cross-section. In some embodiments, when the expandable member 5 is in a contracted state, the radially extending cross-section of the electrode membrane 4 does not protrude from or is as close as possible to the first cross-section. This arrangement ensures that the device is smooth and continuous as a whole, without any protruding structures, making it easier to pass through the digestive tract and avoiding interference from the human body on the shape of the electrode membrane 4.

[0054] A limiting element is also provided between the inner tube 1 and the outer tube. The limiting element is used to limit the movement of the rotating tube 3 relative to the outer tube in the front-back direction. Specifically, in this embodiment, a front limiting element 7 and a rear limiting element 8 are also provided on the outer tube. The rotating tube 3 is located between the front limiting element 7 and the rear limiting element 8. By setting the front limiting element 7 and the rear limiting element 8, the rotating tube 3 is limited in the front-back direction to restrict the position of the inner end 41 of the electrode film in the front-back direction. In some embodiments, the front end of the rotating tube 3 is close to the front limiting element 7, and the rear end of the rotating tube 3 is close to the rear limiting element 8 to prevent the rotating tube 3 from moving relative to the outer tube in the front-back direction. In some embodiments, the rotating tube 3 can move a certain distance relative to the outer tube in the front-back direction to prevent the front limiting element 7 and the rear limiting element 8 from interfering with the rotating tube 3 when the rotating tube 3 rotates relative to the outer tube. In other embodiments, one of the outer tube and the rotating tube 3 may be provided with a circumferentially extending limiting member, and the other of the outer tube and the rotating tube may be provided with a limiting groove that cooperates with the limiting member to limit the movement of the rotating tube 3 relative to the outer tube 1 in the front-back direction.

[0055] In this embodiment, the expandable component 5 is a balloon, specifically a compliant balloon, which is located entirely on one side of the inner tube 1. Specifically, the balloon is positioned outside the cavity 232, and the medium tube 6 is connected to the balloon to control the balloon's changes between a contracted state and an expanded state.

[0056] The device for ablation treatment of the digestive tract in this embodiment can be applied to a system for ablation treatment of the digestive tract. The system also includes a signal generator (not shown in the figure), a pressure source (not shown in the figure), and an operating handle (not shown in the figure). The signal generator is configured to generate an electrical signal for treatment and is electrically connected to the electrodes of the electrode membrane 4. The pressure source is connected to the medium tube 6 and is used to inject or aspirate the medium into the expandable member 5 through the medium tube 6. The operating handle is connected to the proximal end of the outer tube for the user to operate the device in this embodiment.

[0057] The working principle of the device for ablation treatment of the digestive tract in this embodiment is explained below: like Figure 6-10 As shown, at this time, the expandable member 5 is in a contracted state, and the electrode film 4 is also in a contracted state. The expandable member 5 is located between the outermost electrode film 43 and the second outermost electrode film 44. The electrode films 4 inside the second outermost electrode film 44 are spirally wound around the rotating tube 3. When the medium enters the expandable member 5 through the medium tube 6, the expandable member 5 changes from a contracted state to an expanded state. Driven by the expandable member 5, the inner end 41 of the electrode film pulls the rotating tube 3 to rotate relative to the inner tube 1, and the electrode film 4 becomes radially larger, eventually as shown. Figure 1-5As shown, at this time, the expandable member 5 is in an expanded state, and the electrode membrane 4 is also in an expanded state because it is stretched by the expandable member 5. When the medium flows out of the expandable member 5 through the medium tube 6, the expandable member 5 changes from an expanded state to a contracted state. At this time, the elastic force causes the electrode membrane 4 to be further wound around the rotating tube 3.

[0058] Example 2 The main difference between this embodiment and Embodiment 1 is that, in this embodiment, no rotating tube is provided, and the inner end of the electrode film is freely arranged in the circumferential direction relative to the inner tube.

[0059] like Figure 1-2 As shown in Figures 6-7 and 11-16, the device for ablation treatment of the digestive tract in this embodiment includes a slender inner tube 1, a slender outer tube, an electrode membrane 4, and an expandable member 5. Both the electrode membrane 4 and the expandable member 5 have a radially decreasing contraction state and a radially increasing expansion state.

[0060] The inner tube 1 is disposed inside the device in this embodiment and is used to pass through components such as guide wires.

[0061] In the winding direction of the electrode film 4, the electrode film 4 has an inner end portion 41 and an outer end portion 42. Both the outer end portion 42 and the inner end portion 41 extend in the front-back direction. The outer end portion 42 is fixedly disposed with the outer tube. The section of the electrode film containing the inner end portion 41 is wound on the inner tube 1, and the inner end portion 41 is freely disposed in the circumferential direction relative to the inner tube 1. In this embodiment, the entire outer end portion 42 of the electrode film is fixedly connected with the outer tube. In other embodiments, the front and rear portions of the outer end portion 42 of the electrode film may be fixedly connected with the outer tube respectively.

[0062] In this embodiment, the electrode film 4 has an elastic force, which causes the electrode film to tend to transition from an expanded state to a contracted state. The elastic force of the electrode film 4 allows it to be wound in a spiral shape around the inner tube 1. Specifically, the electrode film 4 includes an electrode film body and an elastic sheet attached to the electrode film body. When the expandable member 5 is in a contracted state, the elastic sheet provides the elastic force required to wind the electrode film 4 around the inner tube 1. At least a portion of the electrode film body and the elastic sheet overlap and are fixedly connected in the winding direction. In this embodiment, all electrode film bodies are attached with elastic sheets. In other embodiments, it is not necessary for all electrode films 4 to have elastic sheets in the winding direction. Specifically, in one embodiment, the elastic sheet may have an inner end and an outer end in the winding direction, and the electrode film body may have an inner end and an outer end. In the winding direction, the inner end of the electrode film body and the inner end of the elastic sheet overlap. The inner end of the electrode film body and / or the inner end of the elastic sheet are freely arranged in the circumferential direction relative to the inner tube 1. In another embodiment, the elastic sheet can be configured to have an inner end and an outer end in the winding direction, and the electrode film body has an inner end and an outer end. In the winding direction, the inner end of the electrode film body is located between the inner end and the outer end of the elastic sheet, and the inner end of the elastic sheet is freely arranged in the circumferential direction relative to the inner tube 1.

[0063] The outer tube is fitted over the inner tube 1. Specifically, the outer tube includes a first tapered tube 21, a second tapered tube 22, and a connector 23, which are fixedly connected to each other.

[0064] The first conical tube 21, the connector 23, and the second conical tube 22 are all located at the distal end of the device in this embodiment. The three are arranged in sequence from far to near. The first conical tube 21 is a cone shape that is narrow at the front and wide at the back, and the second conical tube 22 is a cone shape that is wide at the front and narrow at the back, so as to facilitate the passage of the device in the human body.

[0065] The connector 23 has an inner wall 231, which surrounds and forms a cavity 232. A portion of the inner tube 1 is disposed within the cavity 232. The outermost electrode membrane 44 and each of the inner electrode membranes 4 are located within the cavity. Specifically, the inner wall 231 is a circumferential inner wall formed by rotating around the axis of the inner tube 1. When the expandable member 5 is in a contracted state, the inner wall 231 confines at least a portion of the electrode membrane 4 within the cavity 232. The inner wall 231 forms a physical limit on the electrode membrane 4, preventing the electrode membrane 4 from becoming loose and warped or scraping against the inner wall of the digestive tract in the contracted state, thus improving safety and further reducing the outer diameter of the device, thereby enhancing its ability to pass through narrow digestive tract lumens.

[0066] An opening 233 extending in the front-to-back direction is provided on the outer tube. The outermost electrode film 43 passes through the opening 233. The outer tube has two ends 2311 extending in the front-to-back direction, which surround the opening 233. The outer end 42 of the electrode film is fixedly connected to one of the ends 2311. The other end 2311 is used to abut against the outermost electrode film 43 when the electrode film 4 moves relative to the opening 233 to ensure that the electrode film 4 does not twist. The two ends 2311 are located between the first tapered tube 21 and the second tapered tube 22. The first tapered tube 21 has a radially extending first limiting wall 211, and the second tapered tube 22 has a radially extending second limiting wall 211. In the front-back direction, the two ends 2311 of the retaining wall 221 are located between the first retaining wall 211 and the second retaining wall 221. In this embodiment, the cross-sections of the first retaining wall 211 and the second retaining wall 221 form a first cross-section, and the inner wall 231 of the outer tube surrounds and forms a second cross-section extending radially. The second cross-section does not protrude from the first cross-section. In some embodiments, when the expandable member 5 is in a contracted state, the radially extending cross-section of the electrode membrane 4 does not protrude from or is as close as possible to the first cross-section. This arrangement ensures that the device is smooth and continuous as a whole, without any protruding structures, making it easier to pass through the digestive tract and avoiding interference from the human body on the shape of the electrode membrane 4.

[0067] A limiting member is provided between the inner tube 1 and the outer tube to limit the movement of the inner end portion 41 of the electrode membrane relative to the outer tube in the front-back direction. Specifically, in this embodiment, the outer tube is also provided with a front limiting member 7 and a rear limiting member 8. The inner end portion 41 of the electrode membrane is located between the front limiting member 7 and the rear limiting member 8. By providing the front limiting member 7 and the rear limiting member 8, the inner end portion 41 of the electrode membrane is limited in the front-back direction to restrict its position. In some embodiments, the front end portion of the inner end portion 41 of the electrode membrane is in close contact with the front limiting member 7, and the rear end portion of the inner end portion 41 of the electrode membrane is in close contact with the rear limiting member 8 to prevent the inner end portion 41 of the electrode membrane from moving relative to the outer tube in the front-back direction. In some embodiments, the inner end portion 41 of the electrode membrane can move a certain distance relative to the outer tube 1 in the front-back direction to prevent the front limiting member 7 and the rear limiting member 8 from interfering with the inner end portion 41 of the electrode membrane when it rotates relative to the outer tube.

[0068] In this embodiment, the expandable component 5 is a balloon, specifically a compliant balloon, which is located entirely on one side of the inner tube 1. Specifically, the balloon is positioned outside the cavity 232, and the medium tube 6 is connected to the balloon to control the balloon's changes between a contracted state and an expanded state.

[0069] The device for ablation treatment of the digestive tract in this embodiment can be applied to a system for ablation treatment of the digestive tract. The system also includes a signal generator (not shown in the figure), a pressure source (not shown in the figure), and an operating handle (not shown in the figure). The signal generator is configured to generate an electrical signal for treatment and is electrically connected to the electrodes of the electrode membrane 4. The pressure source is connected to the medium tube 6 and is used to inject or aspirate the medium into the expandable member 5 through the medium tube 6. The operating handle is connected to the proximal end of the outer tube for the user to operate the device in this embodiment.

[0070] The working principle of the device for ablation treatment of the digestive tract in this embodiment is explained below: like Figure 6-7 As shown in Figures 14-16, the expandable member 5 is in a contracted state, and the electrode film 4 is also in a contracted state. The expandable member 5 is located between the outermost electrode film 43 and the second outermost electrode film 44. The electrode films 4 inside the second outermost electrode film 44 are spirally wound around the inner tube 1. When the medium enters the expandable member 5 through the medium tube 6, the expandable member 5 changes from a contracted state to an expanded state. Under the drive of the expandable member 5, the inner end 41 of the electrode film rotates relative to the outer tube, and the electrode film 4 becomes radially larger, eventually as shown in Figure 1. Figure 1-2 As shown in Figures 11-13, the expandable member 5 is in an expanded state at this time, and the electrode membrane 4 is also in an expanded state as it is stretched by the expandable member 5. When the medium flows out of the expandable member 5 through the medium tube 6, the expandable member 5 changes from an expanded state to a contracted state. At this time, the elastic force causes the electrode membrane 4 to be further wound around the inner tube 1.

[0071] Example 3 The main difference between this embodiment and Embodiment 1 is that, in this embodiment, no rotating tube is provided, and the inner end of the electrode membrane is fixedly set relative to the inner tube.

[0072] like Figure 1-2 As shown in Figures 6-7 and 17-22, the device for ablation treatment of the digestive tract in this embodiment includes a slender inner tube 1, a slender outer tube, an electrode membrane 4, and an expandable member 5. Both the electrode membrane 4 and the expandable member 5 have a radially decreasing contraction state and a radially increasing expansion state.

[0073] The inner tube 1 is disposed inside the device in this embodiment and is used to pass through components such as guide wires.

[0074] In the winding direction of the electrode film 4, the electrode film 4 has an inner end portion 41 and an outer end portion 42. Both the outer end portion 42 and the inner end portion 41 extend in the front-back direction. The outer end portion 42 is fixedly disposed with the outer tube. The section of the electrode film containing the inner end portion 41 is wound on the inner tube 1, and the inner end portion 41 is fixedly disposed relative to the inner tube 1. In this embodiment, the entire outer end portion 42 of the electrode film is fixedly connected with the outer tube, and the entire inner end portion 41 of the electrode film is fixedly disposed relative to the inner tube 1. In other embodiments, the front and rear portions of the outer end portion 42 of the electrode film can also be fixedly connected with the outer tube, and the front and rear portions of the inner end portion 41 of the electrode film can be fixedly connected with the inner tube 1, respectively.

[0075] In this embodiment, the electrode film 4 has an elastic force, which causes the electrode film to tend to transition from an expanded state to a contracted state. The elastic force of the electrode film 4 allows it to be wound in a spiral shape around the inner tube 1. Specifically, the electrode film 4 includes an electrode film body and an elastic sheet attached to the electrode film body. When the expandable member 5 is in a contracted state, the elastic sheet provides the elastic force required to wind the electrode film 4 around the inner tube 1. At least a portion of the electrode film body and the elastic sheet overlap and are fixedly connected in the winding direction. In this embodiment, all electrode film bodies are attached with elastic sheets. In other embodiments, it is not necessary for all electrode films 4 to have elastic sheets in the winding direction. Specifically, in one embodiment, the elastic sheet may have an inner end and an outer end in the winding direction, and the electrode film body may have an inner end and an outer end. In the winding direction, the inner end of the electrode film body and the inner end of the elastic sheet are overlapped. The inner end of the electrode film body and / or the inner end of the elastic sheet are fixedly connected to the inner tube 1. In another embodiment, the elastic sheet can be configured to have an inner end and an outer end in the winding direction, and the electrode film body has an inner end and an outer end. In the winding direction, the inner end of the electrode film body is located between the inner end and the outer end of the elastic sheet, and the inner end of the elastic sheet is fixedly connected to the inner tube 1.

[0076] The outer tube is fitted over the inner tube 1. Specifically, the outer tube includes a first tapered tube 21, a second tapered tube 22, and a connector 23, which are fixedly connected to each other.

[0077] The first conical tube 21, the connector 23, and the second conical tube 22 are all located at the distal end of the device in this embodiment. The three are arranged in sequence from far to near. The first conical tube 21 is a cone shape that is narrow at the front and wide at the back, and the second conical tube 22 is a cone shape that is wide at the front and narrow at the back, so as to facilitate the passage of the device in the human body.

[0078] The connector 23 has an inner wall 231, which surrounds and forms a cavity 232. A portion of the inner tube 1 is disposed within the cavity 232. The outermost electrode membrane 44 and each of the inner electrode membranes 4 are located within the cavity. Specifically, the inner wall 231 is a circumferential inner wall formed by rotating around the axis of the inner tube 1. When the expandable member 5 is in a contracted state, the inner wall 231 confines at least a portion of the electrode membrane 4 within the cavity 232. The inner wall 231 forms a physical limit on the electrode membrane 4, preventing the electrode membrane 4 from becoming loose and warped or scraping against the inner wall of the digestive tract in the contracted state, thus improving safety and further reducing the outer diameter of the device, thereby enhancing its ability to pass through narrow digestive tract lumens.

[0079] An opening 233 extending in the front-to-back direction is provided on the outer tube. The outermost electrode film 43 passes through the opening 233. The outer tube has two ends 2311 extending in the front-to-back direction, which surround the opening 233. The outer end 42 of the electrode film is fixedly connected to one of the ends 2311. The other end 2311 is used to abut against the outermost electrode film 43 when the electrode film 4 moves relative to the opening 233 to ensure that the electrode film 4 does not twist. The two ends 2311 are located between the first tapered tube 21 and the second tapered tube 22. The first tapered tube 21 has a radially extending first limiting wall 211, and the second tapered tube 22 has a radially extending second limiting wall 211. In the front-back direction, the two ends 2311 of the retaining wall 221 are located between the first retaining wall 211 and the second retaining wall 221. In this embodiment, the cross-sections of the first retaining wall 211 and the second retaining wall 221 form a first cross-section, and the inner wall 231 of the outer tube surrounds and forms a second cross-section extending radially. The second cross-section does not protrude from the first cross-section. In some embodiments, when the expandable member 5 is in a contracted state, the radially extending cross-section of the electrode membrane 4 does not protrude from or is as close as possible to the first cross-section. This arrangement ensures that the device is smooth and continuous as a whole, without any protruding structures, making it easier to pass through the digestive tract and avoiding interference from the human body on the shape of the electrode membrane 4.

[0080] A limiting member is provided between the inner tube 1 and the outer tube to limit the movement of the inner tube 1 relative to the outer tube in the front-back direction. Specifically, in this embodiment, the outer tube is also provided with a front limiting member 7 and a rear limiting member 8. The inner end 41 of the electrode membrane is located between the front limiting member 7 and the rear limiting member 8. By providing the front limiting member 7 and the rear limiting member 8, the inner end 41 of the electrode membrane is limited in the front-back direction to restrict its position. In some embodiments, the front end of the inner end 41 of the electrode membrane is in close contact with the front limiting member 7, and the rear end of the inner end 41 of the electrode membrane is in close contact with the rear limiting member 8 to prevent the inner end 41 of the electrode membrane from moving in the front-back direction. In some embodiments, the inner end 41 of the electrode membrane can move a certain distance relative to the outer tube in the front-back direction to prevent the front limiting member 7 and the rear limiting member 8 from interfering with the inner end 41 of the electrode membrane when it rotates relative to the outer tube.

[0081] In this embodiment, the expandable component 5 is a balloon, specifically a compliant balloon, which is located entirely on one side of the inner tube 1. Specifically, the balloon is positioned outside the cavity 232, and the medium tube 6 is connected to the balloon to control the balloon's changes between a contracted state and an expanded state.

[0082] The device for ablation treatment of the digestive tract in this embodiment can be applied to a system for ablation treatment of the digestive tract. The system also includes a signal generator (not shown in the figure), a pressure source (not shown in the figure), and an operating handle (not shown in the figure). The signal generator is configured to generate an electrical signal for treatment and is electrically connected to the electrodes of the electrode membrane 4. The pressure source is connected to the medium tube 6 and is used to inject or aspirate the medium into the expandable member 5 through the medium tube 6. The operating handle is connected to the proximal end of the outer tube for the user to operate the device in this embodiment.

[0083] The working principle of the device for ablation treatment of the digestive tract in this embodiment is explained below: like Figure 6-7 As shown in Figures 20-22, the expandable member 5 is in a contracted state, and the electrode film 4 is also in a contracted state. The expandable member 5 is located between the outermost electrode film 43 and the second outermost electrode film 44. The electrode films 4 inside the second outermost electrode film 44 are spirally wound around the inner tube 1. When the medium enters the expandable member 5 through the medium tube 6, the expandable member 5 changes from a contracted state to an expanded state. Driven by the expandable member 5, the inner end 41 of the electrode film drives the inner tube 1 to rotate, and the electrode film 4 becomes radially larger, eventually as shown in Figure 20-22. Figure 1-2As shown in Figures 17-19, the expandable member 5 is in an expanded state at this time, and the electrode membrane 4 is also in an expanded state as it is stretched by the expandable member 5. When the medium flows out of the expandable member 5 through the medium tube 6, the expandable member 5 changes from an expanded state to a contracted state. At this time, the elastic force causes the electrode membrane 4 to be further wound around the inner tube 1. Alternatively, the electrode membrane 4 can be further wound around the inner tube 1 by directly rotating the inner tube 1.

[0084] It is understood that the same or similar parts in the above embodiments can be referred to each other, and the contents not described in detail in some embodiments can be referred to the same or similar contents in other embodiments.

[0085] The above embodiments are only for illustrating the technical concept and features of the present invention, and are intended to enable those skilled in the art to understand the content of the present invention and implement it accordingly. They should not be construed as limiting the scope of protection of the present invention. All equivalent changes or modifications made in accordance with the spirit and essence of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A device for ablation therapy of the digestive tract, characterized in that, It includes: A slender inner tube; A slender outer tube is fitted over the inner tube. The outer tube includes a connector with an inner wall that forms a cavity. A rotating tube, wherein the rotating tube is rotatably sleeved outside the inner tube, and both the rotating tube and part of the inner tube are disposed within the cavity; An electrode film has a radially decreasing contraction state and a radially increasing expansion state. In the winding direction of the electrode film, the electrode film has an inner end and an outer end. The outer end is fixedly disposed with the outer tube, and the inner end is fixedly disposed with the rotating tube. An expandable member has a radially decreasing contracted state and a radially increasing expanded state, and the expandable member is biased to one side of the inner tube; when the expandable member is in the contracted state, the electrode film is also in the contracted state, and the expandable member is located between the outermost electrode film and the second outermost electrode film, and each layer of the electrode film inside the second outermost electrode film is spirally wound on the rotating tube; when the expandable member is in the expanded state, the electrode film is stretched open by the expandable member and is in the expanded state.

2. The device for ablation therapy of the digestive tract according to claim 1, characterized in that: The outer tube has an opening extending in the front-to-back direction, and the outermost electrode film passes through the opening.

3. The device for ablation therapy of the digestive tract according to claim 2, characterized in that: The inner wall of the outer tube forms a cavity, and the secondary outer electrode film and each of the electrode films inside the secondary outer electrode film are located within the cavity.

4. The device for ablation therapy of the digestive tract according to claim 1, characterized in that: A limiting member is provided between the inner tube and the outer tube, and the limiting member is used to limit the movement of the rotating tube relative to the outer tube in the front-back direction.

5. The apparatus for ablation therapy of the digestive tract according to claim 4, characterized in that: The outer tube is provided with a front limiting member and a rear limiting member, and the rotating tube is located between the front limiting member and the rear limiting member.

6. The apparatus for ablation therapy of the digestive tract according to claim 4, characterized in that: One of the outer tube and the rotating tube is provided with a circumferentially extending limiting member, and the other of the outer tube and the rotating tube is provided with a limiting groove that cooperates with the limiting member.

7. The apparatus for ablation therapy of the digestive tract according to claim 1, characterized in that: The expandable component is a balloon.

8. The apparatus for ablation therapy of the digestive tract according to claim 1, characterized in that: The electrode membrane is an elastic electrode membrane, and the elasticity causes the electrode membrane to tend to change from an expanded state to a contracted state.

9. The apparatus for ablation therapy of the digestive tract according to claim 8, characterized in that: The electrode membrane includes an electrode membrane body and an elastic sheet attached to the electrode membrane body.

10. The apparatus for ablation therapy of the digestive tract according to claim 2, characterized in that: The outer tube has two ends extending in the front-back direction, and the outer end of the electrode film is fixedly connected to one of the two ends.

11. The apparatus for ablation therapy of the digestive tract according to claim 10, characterized in that: The other end of the two said ends is used to engage with the outermost electrode film when the electrode film moves relative to the opening.

12. The apparatus for ablation therapy of the digestive tract according to claim 3, characterized in that: The outer tube has a first cross-section extending radially, and the inner wall of the outer tube surrounds a second cross-section extending radially, the second cross-section not protruding from the first cross-section.

13. The apparatus for ablation therapy of the digestive tract according to claim 12, characterized in that: When the expandable member is in a contracted state, the radially extending cross section of the electrode film does not protrude beyond the first cross section.

14. A system for ablation therapy of the digestive tract, characterized in that: It includes an apparatus for ablation treatment of the digestive tract as described in any one of claims 1 to 13, further comprising: a signal generator configured to generate an electrical signal for treatment and electrically connected to the electrodes of the electrode membrane; a pressure source connected to a media tube for injecting or aspirating media into the expandable member through the media tube; and an operating handle connected to the proximal end of the outer tube.

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