Devices and systems for ablation therapy of the digestive tract

Abstract

The application discloses a device and system for ablation treatment of digestive tract. The device comprises a catheter assembly, an expandable component, the expandable component comprises a supporting component and an electrode film wound on the outside of the supporting component, the outer end of the electrode film is connected with the outer catheter or the inner catheter through a connector, the connector comprises an outer end rod and a connecting strip, the outer end rod comprises a straight strip part close to the outer end edge of the electrode film and parallel to the axis of the outer catheter, the rear or front end of the straight strip part is deflected towards the direction of the outer end side edge of the electrode film, forming a deflection part, and extending to the rear or front side of the rear or front edge of the electrode film to form a connecting piece, the connecting piece is pivotally connected with the connecting strip of the connector. The length of the electrode film in the circumferential direction cannot be fitted due to the influence of the straight strip part, the warping phenomenon of the outer end of the electrode film caused by the outer end rod can be reduced, and the device of the application can reduce the risk of damage to the digestive tract.

Description

Technical Field

[0001] This invention relates to a medical device, particularly a device for applying energy to the digestive tract to ablate its tissues. Background Technology

[0002] Devices for ablation therapy of the digestive tract typically include a catheter assembly containing a slender middle catheter and a slender outer catheter, and an expandable component containing an electrode membrane located at the distal end of the catheter assembly. Electrodes are mounted on the electrode membrane, and its expansion or contraction is controlled by rotation of the middle catheter relative to the outer catheter. An outer end rod is located at the outer end of the electrode membrane, forming part of the connector between the outer end of the electrode membrane and the outer catheter. However, because the outer end rod is usually made of a rigid material, while the electrode membrane is a flexible, rollable material, the outer end rod causes warping at the outer end of the electrode membrane. This means that during actual use of the ablation device, the outer end of the electrode membrane cannot conform circumferentially to the rolled-up electrode membrane. When the electrode membrane rotates, the sharp outer end of the electrode membrane may damage the digestive tract. Summary of the Invention

[0003] The purpose of this invention is to provide an improved device and system for ablation therapy of the digestive tract, which can reduce the risk of damage to the digestive tract.

[0004] One technical solution of the present invention is: a device for ablation therapy of the digestive tract, comprising: A catheter assembly having a distal end and a proximal end, the catheter assembly including an elongated middle catheter and an elongated outer catheter, the outer catheter being sleeved on the middle catheter, and the middle catheter being rotatably disposed relative to the outer catheter; An expandable component, connected to the distal end of the catheter assembly, includes a flexible electrode membrane having multiple electrodes and a support component located inside the electrode membrane and used to support the electrode membrane. When the middle catheter rotates relative to the outer catheter, the expandable component can switch between a radially decreasing contraction working state and a radially increasing expansion working state. The electrode film is wound around the outside of the support member, the inner end of the electrode film is connected to the support member, and the outer end of the electrode film is connected to the outer conduit through a connector. The connector includes an outer end rod fixedly connected to the outer end of the electrode membrane and a connecting strip with rigidity in the circumferential direction. The outer end rod includes a straight section near the outer edge of the electrode membrane and parallel to the axis of the outer conduit. The rear end of the straight section is deflected toward the outer edge of the electrode membrane to form a deflection section and extends toward the rear side of the rear edge of the electrode membrane to form a connecting piece. The front end of the connecting strip is pivotally connected to the connecting piece, and the pivot is perpendicular to the axis of the outer conduit. The rear end of the connecting strip is connected to the outer conduit. During the process of the expandable component changing from a contracted working state to an expanded working state, the outer end rod gradually moves away from the outer conduit. During the process of the expandable component changing from an expanded working state to a contracted working state, the outer end rod gradually moves closer to the outer conduit.

[0005] Another technical solution of the present invention is: a device for ablation therapy of the digestive tract, comprising: A catheter assembly having a distal end and a proximal end, the catheter assembly including an elongated inner catheter, an elongated middle catheter, and an elongated outer catheter, the middle catheter being sleeved on the inner catheter and rotatably disposed relative to the inner catheter; the outer catheter being sleeved on the middle catheter and rotatably disposed relative to the outer catheter; the inner catheter and the outer catheter being fixedly disposed relative to each other. An expandable component, connected to the distal end of the catheter assembly, includes a flexible electrode membrane having multiple electrodes and a support component located inside the electrode membrane and used to support the electrode membrane. When the middle catheter rotates relative to the outer catheter, the expandable component can switch between a radially decreasing contraction working state and a radially increasing expansion working state. The electrode membrane is wound around the outside of the support member, the inner end of the electrode membrane is connected to the support member, and the outer end of the electrode membrane is connected to the inner conduit via a connector. The connector includes an outer end rod fixedly connected to the outer end of the electrode membrane and a connecting strip with rigidity in the circumferential direction. The outer end rod includes a straight section near the outer edge of the electrode membrane and parallel to the axis of the outer conduit. The front end of the straight section is deflected toward the outer edge of the electrode membrane to form a deflection section and extends toward the front side of the front edge of the electrode membrane to form a connecting piece. The rear end of the connecting strip is pivotally connected to the connecting piece, and the pivot is perpendicular to the axis of the outer conduit. The front end of the connecting strip is connected to the inner conduit. During the process of the expandable component changing from a contracted working state to an expanded working state, the outer end rod gradually moves away from the inner conduit. During the process of the expandable component changing from an expanded working state to a contracted working state, the outer end rod gradually moves closer to the inner conduit.

[0006] In this invention, the shape of the outer end rod is not particularly limited; for example, it can be sheet-like, etc. The word "rod" does not mean that the shape of the outer end rod must be cylindrical.

[0007] In some embodiments, the center line of the straight section is substantially parallel to the center line of the connecting piece.

[0008] In some embodiments, the distance between the centerline of the straight section and the centerline of the connecting piece is 0.5-2 mm; and / or, the width of the straight section or the connecting piece is 0.5-4 mm.

[0009] In some embodiments, the connecting piece is substantially tangent to the electrode film.

[0010] The deflection part is arc-shaped or S-shaped.

[0011] In some embodiments, the pivot is composed of the connecting piece, the connecting strip, and the rotating shaft. The rotating shaft includes a shaft body and a support portion extending from the shaft body toward the electrode film. The support portion includes a bottom wall and two side walls. The bottom wall of the support portion supports at least a portion of the inner wall of the connecting piece. The two side walls of the support portion abut against the two side walls of the connecting piece, respectively.

[0012] In some embodiments, the connecting piece is fixedly connected to the support portion; and / or, the outer end rod is made of a rigid material.

[0013] In some embodiments, the support portion is integrally formed with the shaft body, or the support portion is fixedly connected to the shaft body. The fixed connection method can be, for example, welding or bonding with an adhesive. For example, metals can be welded together, and rigid plastics can be bonded together.

[0014] In some embodiments, the electrode membrane includes an inner surface and an outer surface, the outer surface including a first region and a second region, the plurality of electrodes being disposed parallel to each other in the first region, and the device further including a polymer film layer disposed outside the second region and inside the inner surface of the electrode membrane, the polymer film layer having a thickness of less than 100 μm. Providing the polymer film layer on the entire back surface of the electrode membrane (the inner surface of the electrode membrane) and on both sides of the front surface of the electrode membrane (i.e., the second region of the outer surface of the electrode membrane) reduces the resistance to the expansion and contraction of the electrode membrane with electrodes.

[0015] In some embodiments, the polymer is selected from polytetrafluoroethylene (PTFE), polyethylene (PE), high-density polyethylene (HDPE), polyether ether ketone (PEEK), tetrafluoroethylene-perfluoroalkoxy vinyl ether copolymer (PFA), and perfluoroethylene propylene (FEP).

[0016] In some embodiments, the straight strips are all located on the electrode film.

[0017] In some embodiments, the deflection portion is entirely located on the electrode film.

[0018] In some embodiments, the electrode includes a copper substrate layer and an inert metal layer, wherein the inert metal layer is selected from one or more combinations of platinum, iridium, gold, and silver.

[0019] In some embodiments, the electrode film has a thickness of 0.1-0.5 mm. This relatively thick thickness increases the overall rigidity of the electrode film, which is beneficial for the adhesion between the electrode film and the supporting component.

[0020] In some embodiments, the distance between the front and rear ends of the connecting strip is variably set when the support member changes between a contracted working state and an expanded working state.

[0021] In some embodiments, the rear end of the support member is connected to the central conduit, and the electrode membrane is wound around the support member.

[0022] In some embodiments, the support member has a deformable component, and the deformable component changes shape when the support member changes between a contracted working state and an expanded working state. The deformable component is made of a rigid elastic material, and the deformable component causes the support member to have a radially outward elastic force that changes the working state from the contracted working state to the expanded working state.

[0023] In some embodiments, the support component is a balloon.

[0024] In some embodiments, the connecting strip is a rigid elastic sheet that is radially elastic, and the connecting strip is bent when the support member is in a retracted working state.

[0025] In some embodiments, the connecting bar includes multiple sections, with the ends of adjacent sections pivotally connected to form a chain, an inner or outer conduit pivotally connected to an adjacent section, and an outer end rod pivotally connected to an adjacent section, the axis of each pivot being spatially perpendicular to the outer conduit.

[0026] In some embodiments, the connecting bar includes multiple sections of rod that are slidably connected to form a telescopic rod. The outer end of the rod is pivotally connected to the end of an adjacent section of rod. The outer or inner conduit is pivotally connected to an adjacent section of rod, and the axis of each pivot is spatially perpendicular to the outer conduit.

[0027] In some embodiments, it also includes an operating handle connected to the proximal end of the catheter assembly, the operating handle being used to actuate the middle catheter, causing the middle catheter to rotate relative to the outer catheter.

[0028] The present invention also provides a system for ablation therapy of the digestive tract, comprising a signal generator and the aforementioned device for ablation therapy of the digestive tract, wherein the signal generator is configured to generate an electrical signal for generating electric field energy, and the signal generator is electrically connected to the aforementioned electrodes.

[0029] Compared with the prior art, the present invention has the following advantages: By deflecting the straight section of the outer end rod, which is near the outer edge of the electrode membrane and parallel to the axis of the external conduit, towards the outer edge of the electrode membrane and extending it to the rear or front side of the electrode membrane to form a connecting piece, and then pivotally connecting the connecting piece to the connecting strip of the connector, the length of the electrode membrane that cannot be adhered to in the circumferential direction due to the influence of the straight section becomes smaller. This reduces the warping phenomenon of the outer end of the electrode membrane caused by the light outer end rod, making the outer end of the electrode membrane adhere more closely to the circular electrode membrane during actual use of the ablation treatment device, and reducing the risk of scratching the digestive tract. The device and system for ablation treatment of the digestive tract of the present invention can reduce the risk of damage to the digestive tract. Attached Figure Description

[0030] Figure 1 This is a system diagram of the present invention, and its supporting frame is a first embodiment; Figure 2 for Figure 1 The ablation component is shown in a cross-sectional magnified view along the AA direction, with the expandable component in a contracted working state. Figure 3This is a partial view of the ablation component, with the expandable component in its expansion working state; Figure 4 for Figure 3 A BB-direction sectional view, showing the expandable component in the expansion working state; Figure 5 This is a three-dimensional view of the ablation component from one angle, with the expandable component in its expansion working state. Figure 6 This is a three-dimensional view of the ablation component from another angle, showing the expandable component in its expansion working state. Figure 7 This is a partial view of the ablation component from another angle, omitting the electrode film; the expandable component is in a contracted working state. Figure 8 This is a partial view of the ablation component from another angle, omitting the electrode film; the expandable component is in the expansion working state. Figure 9 for Figure 1 Enlarged cross-sectional view of the operating handle in the CC direction; Figure 10 This is an external view of the ablation component at an angle, with the expandable component in its expansion working state; Figure 11 for Figure 10 The enlarged cross-sectional view along the DD direction shows the expandable component in its expansion working state. Figure 12 for Figure 1 The enlarged cross-sectional view along the EE direction shows the expandable component in a contracted working state. To show the electrode films of each ring, gaps are left between each ring of electrode films. In reality, the electrode films of each ring are tightly attached to each other, and the innermost electrode film is also tightly attached to the outer support rod. Figure 13 This is a partial view of the ablation component from another angle, showing the expandable component in its expansion working state. Figure 14 for Figure 13 A cross-sectional view in the FF direction; Figure 15 This is a partial view of the ablation component from another angle, with the expandable component in a retracted working state. Figure 16 for Figure 15 A cross-sectional view along the GG direction, showing the expandable component in a retracted working state; Figure 17 for Figure 14 The enlarged cross-sectional view in the HH direction shows that gaps are left between the electrode films in order to show the electrode films in each ring. In reality, the electrode films in each ring are close to each other, and the innermost electrode film is also close to the outer support rod. Figure 18 for Figure 16 Enlarged sectional view in direction II; Figure 19 This is a three-dimensional view of the ablation component from one angle, showing the expandable component in its expansion working state. Figure 20 This is a three-dimensional view of the ablation component from another angle, showing the expandable component in its expansion working state. Figure 21 for Figure 9 A magnified cross-sectional view in the JJ direction; Figure 22-1 An axial structural cross-sectional view of one embodiment of the ablation component; Figure 22-2 for Figure 22-1 Enlarged view of point L; Figure 22-3 for Figure 22-1 Enlarged view at point M; Figure 22-4 This is an axial structural cross-sectional view of an embodiment of the ablation component, with the support frame in an expanded working state and the connector connecting the outer ends of the inner conduit and the electrode membrane. Figure 23 for Figure 22-4 A cross-sectional view of the ablation component in the contracted working state; Figure 24 An axial structural cross-sectional view of one embodiment of the ablation component; Figure 25 This is an axial cross-sectional view of the operating handle of the actuator, which drives the outer and middle guide tubes to rotate relative to each other simultaneously. Figure 26 for Figure 25 Enlarged cross-sectional view in the KK direction; Figure 27 An axial structural cross-sectional view of one embodiment of the ablation component; Figure 28 for Figure 27 Axial structural cross-sectional view of the expandable component in its retracted working state; Figure 29-1 This is an axial structural cross-sectional view of an embodiment of the ablation component. The expandable component is in an expanded working state. The connector is connected to the outer end of the electrode film. The connector is also connected to the inner and outer conduits. The connecting strip is a chain. Figure 29-2 This is an axial structural cross-sectional view of an embodiment of the ablation component, in which the expandable component is in an expanding working state, and the connecting strip is a rigid elastic sheet; Figure 29-3 This is an axial structural cross-sectional view of an embodiment of the ablation component, showing the expandable component in an expanded working state, with the connecting bar being a telescopic rod. Figure 30 An axial structural cross-sectional view of an embodiment of the ablation component without an internal catheter, with the expandable component in a contracted working state; Figure 31 for Figure 30 Axial structural cross-sectional view of the expandable component in its expanded working state; Figure 32 An axial structural cross-sectional view of an embodiment of the ablation component without an inner catheter is shown. The expandable component is in a contracted working state, and both the front and rear connecting rings are slidably connected to the middle catheter in the front-rear direction but are prohibited from rotating. Figure 33 for Figure 32 Axial structural cross-sectional view of the expandable component in its expanded working state; Figure 34 The ablation component has no inner catheter. The axial cross-sectional view of the actuator's operating handle shows the actuator driving the middle catheter to rotate relative to the outer catheter. Figure 35-1 This is an axial structural cross-sectional view of an embodiment of the ablation component. The expandable component is in an expanded working state, and the inner middle section of the inner support skeleton is fixedly connected to the central conduit. Figure 35-2 This is an axial structural cross-sectional view of an embodiment of the ablation component. The expandable component is in a contracted working state, and the inner middle section of the inner support skeleton is fixedly connected to the central conduit. Figure 36-1 This is an axial structural cross-sectional view of an embodiment of the ablation component. The expandable component is in an expanded working state, and the inner middle section of the inner support skeleton is fixedly connected to the central conduit. Figure 36-2 This is an axial structural cross-sectional view of an embodiment of the ablation component. The expandable component is in a contracted working state, and the inner middle section of the inner support skeleton is fixedly connected to the central conduit. Figure 37-1 This is a schematic diagram of a device for gastrointestinal ablation therapy according to an embodiment of the present invention, wherein the expandable component is in an expanding working state; Figure 37-2 for Figure 37-1 Cross-sectional view along the NN direction; Figure 37-3 This is a schematic diagram of the structure of a device for gastrointestinal ablation therapy according to an embodiment of the present invention, wherein the expandable component is in an expanding working state; Figure 37-4 for Figure 37-3 Cross-sectional view along the OO direction; Figure 37-5 for Figure 37-4 A magnified view of a portion of point P in the middle; Figure 37-6 This is a partial structural schematic diagram of a device for gastrointestinal ablation therapy according to an embodiment of the present invention; Figure 37-7 for Figure 37-6 Cross-sectional view along the QQ direction; Figure 37-8 This is a partial structural schematic diagram of a device for gastrointestinal ablation therapy according to an embodiment of the present invention, wherein the expandable component is in a contracted working state; Figure 37-9 for Figure 37-8 Cross-sectional view along the RR direction; Figure 37-10 This is a partial structural schematic diagram of a device for gastrointestinal ablation therapy according to an embodiment of the present invention, wherein the expandable component is in a contracted working state. Figure 37-11 for Figure 37-10 Cross-sectional view along the SS direction; Figure 37-12 and Figure 37-13 This is a three-dimensional schematic diagram of the support frame after expansion according to an embodiment of the present invention; Figure 37-14 This is a side view of the support frame after expansion according to an embodiment of the present invention; Figure 37-15 This is a three-dimensional schematic diagram of the support frame after shrinkage according to an embodiment of the present invention; Figure 37-16 This is a side view of the support frame after it has been retracted, according to an embodiment of the present invention. Figure 37-17 This is a cross-sectional schematic diagram of another device for gastrointestinal ablation therapy according to an embodiment of the present invention, wherein no internal catheter is provided; Figure 37-18 for Figure 37-1 A partial enlarged view of the device used for ablation therapy of the digestive tract; Figure 37-19 for Figure 37-2 A partial enlarged view of the device used for ablation therapy of the digestive tract; Figure 37-20 for Figure 37-3 A partial enlarged view of the device used for ablation therapy of the digestive tract; Figure 37-21 for Figure 37-4 A partial enlarged view of the device used for ablation therapy of the digestive tract; Figure 37-22 for Figure 37-17 A partial enlarged view of the device used for ablation therapy of the digestive tract; Figure 38A three-dimensional schematic diagram showing the specific structure of the connector of the device for ablation treatment of the digestive tract, in the contracted working state. Figure 39 for Figure 38 Enlarged view at the middle T; Figure 40 This is a structural diagram of a connector, with the device in a retracted working state; Figure 41 This is a schematic diagram of the connector from another direction, showing the device in a retracted working state. Figure 42 This is a three-dimensional structural diagram of the connector and electrode film when they are connected, with the device in a retracted working state. Figure 43 This is a schematic diagram of the structure when the connector is connected to the electrode film, with the device in a retracted working state; Figure 44 for Figure 43 Cross-sectional view along the VV direction; Figure 45 This is another schematic diagram of the structure when the connector is connected to the electrode film, with the device in a retracted working state; Figure 46 for Figure 45 Cross-sectional view along the UU direction; Figure 47 This is a schematic diagram of the front view of the structure when the connector is connected to the electrode film and the electrode film is laid flat. Figure 48 for Figure 47 Cross-sectional view along the WW direction; Figure 49 for Figure 48 Enlarged view at point X; Figure 50 for Figure 47 Top view; Figure 51 for Figure 47 Cross-sectional view along the YY direction; Figure 52 This is a three-dimensional structural diagram of the connector and electrode film when they are connected. Figure 53 for Figure 52 Enlarged view at point Z; Figure 54 A three-dimensional schematic diagram showing another specific structure of the connector of the device for ablation treatment of the digestive tract, in the contracted working state; Figure 55 for Figure 54 Enlarged view of section IV in the middle.

[0031] in, 100. Catheter Assembly; 1. Inner Catheter; 2. Middle Catheter; 3. Outer Catheter; 4. Expandable Component; 5. Support Frame; 6. Electrode Membrane; 7. Electrode; 8. Inner End of Electrode Membrane; 9. Outer End of Electrode Membrane; 10. Internal Gear; 11. Intermediate Gear; 12. Front Connecting Ring; 13. Rear Connecting Ring; 14. Outer End Rod; 15. Connecting Strip; 16. Internal Gear Ring; 17. Section Rod; 18. Pivot; 19. Inner Support Frame; 20. Outer Support Rod; 21. Front Extension Section; 22. Rear Extension Section; 23. Middle Support Frame; 24. Inner Support Rod; 25. Middle Support Rod; 26. Front End of Middle Support Rod; 27. Rear End of Middle Support Rod; 28. 29. Operating handle; 30. Front guide cap; 31. Guide wire cavity; 32. Signal generator; 33. Rear guide cap; 34. Sliding groove; 35. Knob; 36. Operating handle body; 37. Rivet; 38. First bevel gear; 49. Second bevel gear; 40. Third bevel gear; 41. Annular protrusion; 52. First connecting rod; 52a. Front end; 52b. Rear end; 53. Second connecting rod; 53a. Front end; 53b. Rear end; 54. Cutting line; 60. Straight section; 61. Connecting piece; 62. Shaft body; 63. Support section; 64. Coating layer; 65. Polymer film layer; 66. Terminal block; 67. Wire fixing point; 68. Deflection section. Detailed Implementation

[0032] The embodiments will be further described below with reference to the accompanying drawings. The digestive tract of this invention refers to the oral cavity, esophagus, stomach, duodenum, small intestine, large intestine, anus, etc. The upper digestive tract refers to the areas into which the ablation component of this invention can extend, including the esophagus, stomach, and duodenum. This invention is particularly applicable to the upper digestive tract. In this invention, "front" refers to the direction in which the ablation component advances into the digestive tract, and "rear" refers to the direction in which it retracts, for example... Figure 1In this invention, the front guide cap 29 facing left is the front, and the operating handle 28 facing right is the rear. The terms "front" and "rear" in this invention are also defined in this direction. In this invention, "axial" refers to the direction of the centerline of the middle conduit. In this invention, "radial" refers to the radial direction of the middle conduit, which is perpendicular to the axial direction of the middle conduit; "circumferential" refers to the circumferential direction of the middle conduit. In this invention, for concentrically connected and extending components (e.g., between the outer conduit, middle conduit, and inner conduit), their respective axial, radial, and circumferential directions are the same. In this invention, "inner" is relative to "outer." Therefore, "inner side" or "inner end" refers to the side or end radially closer to the inner conduit (or closer to the middle conduit in embodiments without an inner conduit), and "outer side" or "outer end" refers to the side or end radially farther from the inner conduit (or farther from the middle conduit in embodiments without an inner conduit). "Front end" also refers to the end further away from the operator (doctor), and is also known in the industry as the distal end; "rear end" refers to the end closer to the operator, and is also known in the industry as the proximal end. In this invention, "part" (e.g., "front," "rear," "external," "internal") used with directional terms refers to the portion beyond the corresponding median line; for example, "front" refers to the portion located in front of the median line in the front-back direction. Conversely, "end" or "end point" (e.g., "front end," "rear end," "outer end," "inner end") used with directional terms refers to the portion beyond the corresponding median line and furthest from it; for example, "front end" or "front end" refers to the front portion beyond the median line in the front-back direction and furthest from it. Therefore, the "end point" in the corresponding direction is part of the "part" (e.g., "front end point" is part of "front"). Correspondingly, "front middle" refers to the part between the center line in the front-to-back direction and "front end", and both "front middle" and "front end" belong to "front"; "rear middle" refers to the part between the center line in the front-to-back direction and "rear end", and both "rear middle" and "rear end" belong to "rear".

[0033] Unless otherwise specified, in this invention, "a component is perpendicular to or parallel to another component" means that the axis of one component is perpendicular to or parallel to the axis of the other component. For example, "a pivot is perpendicular to the central guide tube" means that the axis of the pivot is perpendicular to the axis of the central guide tube. Similarly, "the electrode membrane connector is parallel to the central guide tube" means that the axis of the electrode membrane connector is parallel to the axis of the central guide tube. The terms "forward" and "reverse" in this invention are merely definitions for ease of understanding of the relevant embodiments and can refer to counterclockwise or clockwise directions, or vice versa. Figure 20For example, from the perspective of the near end to the far end, "forward" means counterclockwise, which is also the direction in which the electrode film 6 is wound; "reverse" means clockwise. The descriptions of "forward" and "reverse" are intended to facilitate understanding of the solutions of the relevant embodiments of the present invention. Those skilled in the art should understand that they refer to the ability to rotate, expand, and contract the corresponding components through rotation, and do not constitute a limitation on the scope of protection of the present invention.

[0034] To facilitate the description of the technical solution of the present invention, the term "connection" in the present invention refers to the direct connection between two components. The connection forms include at least five types of connection structures: a first type of connection structure - pivot connection, a second type of connection structure - fixed connection, a third type of connection structure - circumferentially rotatable but not sliding in the front-back direction, a fourth type of connection structure - circumferentially non-rotatable but sliding in the front-back direction, and a fifth type of connection structure - circumferentially rotatable but sliding in the front-back direction. The first type of connection structure: pivot connection, where two components are rotatably connected via a pivot, also known as hinge connection; the second type of connection structure: the fixed connection, where two components are connected by welding, riveting, or by a third component, directly or by a third component, or by integral molding; the third type of connection structure: the circumferentially rotatable but non-sliding connection is equivalent to a connection that allows relative circumferential rotation but axial positioning (axial non-sliding), for example, the first component is fitted onto the second component, the first component has a radially recessed annular groove in the circumferential direction, and the second component has a radially protruding part that inserts into the recess, or vice versa, the second component has a radially recessed annular groove in the circumferential direction, and the first component has a radially protruding part that inserts into the recess. Within the recess, the annular groove and radial protrusion engage with each other, thus restricting sliding in the front-to-back direction, while allowing rotation relative to each other; the fourth connection structure: a connection form in which relative rotation in the circumferential direction is not possible, but sliding in the front-to-back direction, for example, the first component has a radially recessed and axially extending groove, and the second component has a radially protruding and axially extending guide block, the guide block being inserted into the recess; similarly, a connection that slides in a certain direction is one in which a guide groove or guide hole is opened in a certain direction on the first component, and a protrusion on the second component is inserted into the guide groove or guide hole, so that the two can slide together in a certain direction; the fifth connection structure: the connection method in which relative rotation in the circumferential direction is possible and sliding in the front-to-back direction, for example, the first component is fitted onto the second component without any protrusions or grooves, and the two can rotate freely relative to each other and move radially.

[0035] In each embodiment, when the device is inserted into a location such as the human duodenum for ablation surgery, the defined rotating component refers to the component that rotates circumferentially relative to the duodenum during the transition of the expandable component from a contracted working state to an expanded working state, while the defined reference component is the component that does not rotate circumferentially relative to the duodenum. However, the definitions can also be reversed. Regardless of the definition, during the transition of the expandable component from a contracted working state to an expanded working state, the defined rotating component and the defined reference component are arranged to rotate relative to each other. The actively rotating component can be either the defined rotating component or the defined reference component.

[0036] The technical solution of the present invention will now be described in conjunction with the accompanying drawings.

[0037] refer to Figure 1-53 Especially Figures 38 to 53 This embodiment provides a device for ablation therapy of the digestive tract, which includes: The catheter assembly 100 includes an elongated middle catheter 2 and an elongated outer catheter 3, the outer catheter 3 being sleeved on the middle catheter 2, and the middle catheter 2 being rotatably disposed relative to the outer catheter 3; The expandable component 4, which is connected to the distal end of the catheter assembly 100, includes a flexible electrode membrane 6 having multiple electrodes 7 and a support component located inside the electrode membrane 6 and used to support the electrode membrane 6. When the catheter 2 rotates relative to the outer catheter 3, the expandable component 4 can switch between a radially decreasing contraction working state and a radially increasing expansion working state.

[0038] The support component can be a support frame 5, or other support components, such as a balloon. The electrode membrane 6 is wound around the outside of the support component, the inner end of the electrode membrane 6 is connected to the support component, and the outer end of the electrode membrane 6 is connected to the external conduit 3 through a connector.

[0039] In this embodiment, the rear end of the support frame 5 is connected to the central conduit 2, and the electrode film 6 is wound around the support frame 5.

[0040] Specifically, the connector includes an outer end rod 14 fixedly connected to the outer end of the electrode membrane 6 and a connecting strip 15 with rigidity in the circumferential direction. The outer end rod 14 includes a straight section 60 near the outer edge of the electrode membrane 6 and parallel to the axis of the outer conduit 3. The rear end of the straight section 60 is deflected toward the outer edge of the electrode membrane 6 to form a deflection section 68, and extends toward the rear side of the rear edge of the electrode membrane 6 to form a connecting piece 61. The front end of the connecting strip 15 is pivotally connected to the connecting piece 61, and the pivot is perpendicular to the axis of the outer conduit 3. The rear end of the connecting strip 15 is connected to the outer conduit 3. During the process of the expandable component changing from the contracted working state to the expanded working state, the outer end rod 14 gradually moves away from the outer conduit 3. During the process of the expandable component changing from the expanded working state to the contracted working state, the outer end rod 14 gradually moves closer to the outer conduit 3.

[0041] The present invention does not impose any special limitation on the shape of the outer end rod 14, and the word "rod" in its name does not necessarily mean that its shape is cylindrical. Its shape can also be a thin sheet, etc.

[0042] The outer end rod 14 is typically made of a rigid material, while the electrode membrane 6 is a flexible, rollable material. The presence of the outer end rod 14 at the outer end of the electrode membrane 6 causes some warping at the outer end. By deflecting the end of the straight section 60 of the outer end rod 14, which is near the outer edge of the electrode membrane 6 and parallel to the axis of the external conduit 3, towards the outer end of the electrode membrane 6 to form a deflection section 68, and extending it to the rear side of the rear edge of the electrode membrane 6 to form a connecting piece 61, which is then pivotally connected to the connecting strip 15 of the connector, the warping of the outer end of the electrode membrane 6 caused by the outer end rod 14 can be reduced. This makes the ablation treatment device less likely to scratch the digestive tract during actual use, further improving safety.

[0043] like Figure 40As shown in Figures 42, 45, 47, and 52, the centerline of the straight section 60 is substantially parallel to the centerline of the connecting piece 61. This substantially parallel arrangement further reduces the warping of the outer end of the electrode membrane 6, allowing it to fit more closely to the inner electrode membrane 6 during the device's contracted working state. Since the outer end rod 14 is made of a rigid material, reduced warping improves safety when the device passes through the digestive tract. The present invention does not particularly limit the degree and shape of the deflection of the deflection section 68. For example, the shape of the deflection section 68 can be an arc or an S-shape, preferably a smooth deflection. For the degree of deflection, for example, the distance between the centerline of the straight section 60 and the centerline of the connecting piece 61 can be 0.5-2 mm. The width of the straight section 60 or the connecting piece 61 is typically 0.5-4 mm. The connecting piece 61 is substantially tangent to the electrode membrane 6. The straight section 60, the deflection section 68, and the connecting piece 61 can be fixedly connected or integrally formed, preferably integrally formed. The straight sections 60 are entirely located on the electrode film 6, and the deflection sections 68 are also entirely located on the electrode film 6. The straight sections 60 and deflection sections 68 can be directly pressed onto the outside of the electrode film 6 and exposed thereon, or they can be... Figure 42 As shown in Figures 47 and 52, a coating layer 64 is provided on the outer side of the electrode membrane 6 near its outer edge, with the straight section 60 and the deflection section 68 located between the coating layer 64 and the electrode membrane 6. This reduces the risk of scratching the digestive tract caused by the hard material of the straight section 60 and the deflection section 68.

[0044] like Figure 39 As shown, for the pivotal connection between the connecting strip 15 and the connecting piece 61, the pivot is composed of the connecting piece 61, the connecting strip 15, and a rotating shaft. The rotating shaft includes a shaft body 62 and a support portion 63 extending from the shaft body 62 toward the electrode film 6. The support portion 63 includes a bottom wall and two side walls. The bottom wall of the support portion 63 supports at least a portion of the inner wall of the connecting piece 61; the two side walls of the support portion 63 abut against the two side walls of the connecting piece 61, respectively. This arrangement of the support portion 63 allows the connecting piece 61 to be more securely connected to the shaft body 62. The connecting piece 61 and the support portion 63 are fixedly connected, for example, by welding or by adhesive bonding. For example, metals can be welded together, and rigid plastics can be bonded together. The support portion 63 is integrally formed with the shaft body 62, or the support portion 63 is fixedly connected to the shaft body 62.

[0045] like Figures 47-52As shown, the area of ​​the electrode film 6 other than where the electrodes 7 are located can be edge-wrapped with a film layer. Specifically, the electrode film 6 includes an inner surface and an outer surface. The outer surface includes a first region and a second region. Multiple electrodes 7 are arranged parallel to each other at intervals in the first region. The ablation device also includes a polymer film layer disposed on the outer side of the second region and the inner side of the inner surface of the electrode film 6. The thickness of the polymer film layer is less than 100 μm, preferably less than 50 μm. That is, in addition to the area where multiple electrodes 7 are located on the front side (outer surface) of the electrode film 6, polymer film layers are also disposed on the front and rear ends of multiple electrodes 7, as well as on the back side (inner surface) of the electrode film 6. The electrode film 6 is a flexible insulating and pressure-resistant material, such as a polyimide film, polyester film, PEEK film, PET film, etc. The edge-wrapping polymer film layer can be polytetrafluoroethylene (PTFE), polyethylene (PE), high-density polyethylene (HDPE), polyetheretherketone (PEEK), tetrafluoroethylene-perfluoroalkoxy vinyl ether copolymer (PFA), polytetrafluoroethylene propylene (FEP), etc. The polymer film layer can reduce the resistance to the expansion and contraction of the electrode film with electrodes. The outer end rod 14 is made of a rigid material, such as metal or rigid plastic. If it is metal, it can be welded to the rotating shaft; if it is rigid plastic, it can be bonded to the rotating shaft with an adhesive. Metal, such as steel, is preferred. The electrode film 6 has a thickness of 0.1-0.5 mm. This relatively thick thickness increases the overall rigidity of the electrode film 6, which is beneficial for the adhesion between the electrode film 6 and the supporting component.

[0046] For electrode 7, such as Figures 47-48 As shown in Figures 50-52, a plurality of electrodes 7 are arranged parallel to each other on the outer side of the electrode film 6. Their shapes are not particularly limited; for example, the outer surfaces of the plurality of electrodes 7 can be arc-shaped. As for the material of the electrodes 7, they can be conventional electrode materials. Preferably, the electrodes 7 include a copper substrate layer and an inert metal layer. The inert metal layer is selected from one or a combination of platinum, iridium, gold, and silver.

[0047] like Figures 47-53 As shown, the ablation device also includes a wiring board 66, which is connected to the rear end of the electrode film 6 and located inside the connecting piece 61. It does not directly contact the connecting piece 61. Multiple wire fixing points 67 are provided on both the front and back of the wiring board 66. The wire fixing points 67 are electrically connected to the electrode 7.

[0048] like Figures 54-55 As shown, another embodiment of the present invention provides a catheter assembly for an ablation treatment of the digestive tract, which further includes an elongated inner catheter 1, and the front end of a connecting strip 15 is connected to the inner catheter 1.

[0049] Specifically, the device includes: A catheter assembly 100 having a distal end and a proximal end includes an elongated inner catheter 1, an elongated middle catheter 2, and an elongated outer catheter 3. The middle catheter 2 is sleeved on the inner catheter 1 and is rotatably disposed relative to the inner catheter 1. The outer catheter 3 is sleeved on the middle catheter 2 and is rotatably disposed relative to the outer catheter 3. The inner catheter 1 and the outer catheter 3 are relatively fixed.

[0050] The expandable component 4, which is connected to the distal end of the catheter assembly 100, includes a flexible electrode membrane 6 having multiple electrodes 7 and a support component located inside the electrode membrane 6 and used to support the electrode membrane 6. When the catheter 2 rotates relative to the outer catheter 3, the expandable component 4 can switch between a radially decreasing contraction working state and a radially increasing expansion working state.

[0051] The electrode membrane 6 is wound around the outside of the support component, the inner end of the electrode membrane 6 is connected to the support component, and the outer end of the electrode membrane 6 is connected to the inner conduit 1 through a connector. The connector includes an outer end rod 14 fixedly connected to the outer end of the electrode membrane 6 and a connecting strip 15 that is rigid in the circumferential direction. The outer end rod 14 includes a straight section 60 near the outer edge of the electrode membrane 6 and parallel to the axis of the outer conduit 3. The front end of the straight section 60 is deflected toward the outer edge of the electrode membrane 6 to form a deflection section 68, and extends toward the front side of the front edge of the electrode membrane 6 to form a connecting piece 61. The rear end of the connecting strip 15 is pivotally connected to the connecting piece 61, and the pivot is perpendicular to the axis of the outer conduit 3. The front end of the connecting strip 15 is connected to the inner conduit 1. During the process of the expandable component changing from the contracted working state to the expanded working state, the outer end rod 14 gradually moves away from the inner conduit 1. During the process of the expandable component changing from the expanded working state to the contracted working state, the outer end rod 14 gradually moves closer to the inner conduit 1.

[0052] The specific structures of the connector, outer end rod 14, straight section 60, deflection section 68, and connecting piece 61 are the same as in the aforementioned embodiments.

[0053] The device for ablation treatment of the digestive tract also includes an actuator that drives the connected middle catheter 2 to rotate relative to the outer catheter 3 and / or the inner catheter 1, causing the expandable component 4 to switch between a contraction state and a dilation state. (Reference) Figure 1 The actuator is the operating handle 28, and its specific structure will be explained later in conjunction with the accompanying drawings.

[0054] This embodiment also provides a system for ablation therapy of the digestive tract, see reference. Figure 1 As shown, it includes a signal generator 31 and any of the aforementioned and subsequent devices for ablation treatment of the digestive tract. The signal generator 31 is configured to generate an electrical signal for generating electric field energy, and the signal generator 31 is electrically connected to the electrode 7.

[0055] The following description, in conjunction with the accompanying drawings, introduces other structures of the device for ablation treatment of the digestive tract, particularly the connector in this invention, especially the straight section 60 and the connecting piece 61. Specifically, it provides a detailed and exemplary description of the specific structure of the support frame 5 in the expandable component 4, the connection relationships between the various components in the device, and the control method for transitioning from a contracted state to an expanded state. It should be noted that although the corresponding drawings and text may omit the straight section 60 and the connecting piece 61 described above, in these solutions, the working state of the expandable component 4 is controlled by rotating two different parts of the catheter assembly (e.g., between the middle catheter 2 and the outer catheter 3, and / or between the middle catheter 2 and the inner catheter 1, etc.) relative to each other. Based on this, and in conjunction with the foregoing description of the straight section 60 and the connecting piece 61, those skilled in the art fully understand the method of setting the corresponding straight section 60 and the connecting piece 61, and the various solutions described below can also include the aforementioned connector (containing the straight section 60 and the connecting piece 61).

[0056] One technical solution of the present invention is a device for ablation therapy of the digestive tract, comprising: The slender central conduit 2 can be a tubular body with an internal cavity forming a channel, or it can be solid. The slender outer conduit 3 is sleeved on the outside of the middle conduit 2. Of the two components, the middle conduit 2 and the outer conduit 3, one component is defined as a reference component and the other component is defined as a rotating component. The rotating component is rotatably arranged relative to the reference component. In some embodiments, the middle conduit 2 is defined as a rotating component and the outer conduit 3 is defined as a reference component. Expandable component 4 has a radially decreasing contraction working state and a radially increasing expansion working state. Expandable component 4 includes: The support frame 5 is connected to the defined rotating component, and the support frame 5 has a deformable component; the deformable component has an elastic force that causes the support frame 5 to tend to increase radially. An electrode membrane 6 is configured with electrodes 7 for receiving electrical signals. The electrode membrane is wound around the outside of a support frame 5, and its inner end 8 is connected to the support frame 5. The defined reference component is connected to the outer end of the electrode membrane 6. (Reference) Figure 12 The inner end 8 of the electrode film does not have to be an absolute end; a certain margin can be left. Similarly, the outer end 9 of the electrode film does not have to be an absolute end; a certain margin can also be left.

[0057] In some embodiments, the connection between the support frame 5 and the defined rotating component is configured to restrict circumferential rotation between them, such that when the rotating component rotates relative to the reference component, it can cause the support frame 5 to rotate relative to the reference component; and the connection between the outer end of the electrode film 6 and the defined reference component is configured to restrict circumferential rotation between them, such that when the rotating component rotates relative to the reference component, the rotating component also rotates relative to the outer end of the electrode film 6. The optimal solution for restricting the movement of two components in a certain direction (e.g., circumferential rotation) as referred to in this invention is to prevent misalignment in that direction (e.g., a non-rotatable circumferential arrangement), allowing them to move synchronously in that direction. In other embodiments, they may be misaligned in that direction, but the movement of either component in that direction can cause the other to move accordingly (similar to dragging an object with a rope).

[0058] In some embodiments, if the defined rotating component rotates relative to the defined reference component, the defined rotating component drives the support frame 5 to rotate relative to the defined reference component, and then the inner end of the electrode film 6 rotates relative to the outer end of the electrode film 6. The deformable component undergoes elastic deformation so that the support frame 5 abuts against the inner side of the electrode film 6, and the expandable component 4 switches between a contracted working state and an expanded working state.

[0059] In some embodiments, the support frame 5 is configured to be non-rotatable in the circumferential direction relative to the defined rotating component. For example, the support frame 5 is directly or indirectly fixedly connected to the rotating component by means of additional components. The corresponding connection methods will be described exemplarily in conjunction with the figures and some embodiments below.

[0060] In some embodiments, the outer end of the electrode film 6 is configured to be non-rotatable in the circumferential direction relative to the defined reference component. For example, the electrode film 6 is directly or indirectly fixedly connected to the reference component by means of additional components. The corresponding connection methods will be described exemplarily in conjunction with the figures and some embodiments later.

[0061] In some embodiments, when the expandable component 4 is in a contracted working state, the electrode film 6 and the support frame 5 are also in a radially shrinking contracted working state; when the expandable component 4 is in an expanded working state, the electrode film 6 and the support frame 5 are also in a radially expanding expanded working state.

[0062] See Figures 1 to 29-3Another technical solution of the present invention is a device for ablation therapy of the digestive tract. The difference from the aforementioned embodiments is that this device also includes an inner catheter 1. Specifically, the catheter assembly of this device for ablation therapy of the digestive tract includes a slender inner catheter 1, a slender middle catheter 2, a slender outer catheter 3, and an expandable component 4. The middle catheter 2 is sleeved outside the inner catheter 1, and the outer catheter 3 is sleeved outside the middle catheter 2. Among the three components—inner catheter 1, middle catheter 2, and outer catheter 3—at least one component is defined as a reference component, and at least one other component is defined as a rotating component. The rotating component is rotatably disposed relative to the reference component. In this embodiment, the middle catheter 2 is defined as a rotating component, and the outer catheter 3 is defined as a reference component. The expandable component 4 has a radially shrinking contraction working state and a radially expanding expansion working state. The expandable component 4 includes a support frame 5 and an electrode film 6. The support frame 5 is connected to a defined rotating component. The support frame 5 has a deformable component. The deformable component has an elastic force that causes the support frame 5 to have a radially expanding tendency. The electrode membrane 6 is configured with electrodes 7 for receiving electrical signals. The electrode membrane 6 is wound around the outside of the support frame 5. The inner end of the electrode membrane 6 is connected to the support frame 5. At least one of the defined reference components is connected to the outer end of the electrode membrane 6.

[0063] In some embodiments, when the expandable component 4 is in a contracted working state, the electrode film 6 and the support frame 5 are also in a radially shrinking contracted working state; when the expandable component 4 is in an expanded working state, the electrode film 6 and the support frame 5 are also in a radially expanding expanded working state.

[0064] In some embodiments, if the defined rotating component rotates relative to the defined reference component, the defined rotating component drives the supporting frame 5 to rotate relative to the defined reference component, thereby causing the inner end of the electrode membrane 6 to rotate relative to the outer end of the electrode membrane 6. The deformable component undergoes elastic deformation, causing the supporting frame 5 to abut against the inner surface of the electrode membrane 6, and the expandable component 4 switches between a contracted working state and an expanded working state. The device for ablation treatment of the digestive tract equipped with this expandable component 4 can not only control the expansion and contraction of the electrode membrane 6, but also ensure that the electrode membrane 6 has better rigidity during and after expansion.

[0065] In the three components—inner conduit 1, middle conduit 2, and outer conduit 3—for example, when the outer conduit 3 is defined as the reference component and the middle conduit 2 is defined as the rotating component, the middle conduit 2 is rotatably arranged relative to the outer conduit 3, while the outer conduit 3 is fixedly connected relative to the inner conduit 1. This device not only enables control over the expansion and contraction of the electrode membrane 6 but also ensures better radial outward rigidity of the electrode membrane 6 during and after expansion. The inner conduit 1 can be a tubular body with a channel forming an internal cavity, or it can be solid.

[0066] Another technical solution of the present invention is an expandable component 4 of a device for ablation therapy of the digestive tract. The expandable component 4 has a radially shrinking contraction working state and a radially enlarging expansion working state. The expandable component 4 includes a support frame 5 and an electrode membrane 6. The support frame 5 has a deformable component; the deformable component has an elastic force that causes the support frame 5 to tend to expand radially. The support frame 5 is used to connect with a defined rotating component. The electrode membrane 6 is configured with electrodes 7 for receiving electrical signals. The electrode membrane 6 is wound around the outside of the support frame 5. The inner end of the electrode membrane 6 is connected to the support frame 5. The outer end of the electrode membrane 6 is configured to connect with a defined reference component. The rotating component is rotatably disposed relative to the reference component. The outer end of the electrode membrane 6 is not rotatably disposed relative to the defined reference component in the circumferential direction.

[0067] In some embodiments, when the expandable component 4 is in a contracted working state, the electrode film 6 and the support frame 5 are also in a radially shrinking contracted working state; when the expandable component 4 is in an expanded working state, the electrode film 6 and the support frame 5 are also in a radially expanding expanded working state.

[0068] In some embodiments, if the defined rotating component rotates relative to the defined reference component, the defined rotating component drives the support frame 5 to rotate, and the inner end of the electrode film 6 rotates relative to the outer end of the electrode film 6. The deformable component undergoes elastic deformation so that the support frame 5 abuts against the inner side of the electrode film 6, and the expandable component 4 switches between a contracted working state and an expanded working state.

[0069] The support frame 5 of this invention has an expanding working state and a contracting working state. In the expanding working state, the outer edge of the middle part of the support frame 5 expands radially outward, and in the contracting working state, the outer edge of the middle part of the support frame 5 contracts radially inward. The support frame 5 has a deformable component, which has an elastic force that causes the support frame 5 to tend to expand radially. The deformable component can be made of an elastic material (e.g., titanium-nickel alloy), an elastic structure (e.g., an external component torsion spring, a localized molding structure of the support frame 5, etc.), or a combination of both to provide the required elastic force. The deformable component can be a locally provided structure, material, or additional component of the support frame 5, or the entire support frame 5 can be elastic, in which case the entire support frame 5 is the deformable component. When the support frame 5 is in either of the two working states, some rigid rods (or components, such as the inner support rod 24) on the support frame 5 are elastic and will change shape. In the contracting working state, these deformable components are compressed by the binding force of the electrode film 6, forming potential energy, so that the support frame 5 always tends to change towards the expanding working state. When the diameter of the electrode film 6 increases, the deformation component of the support frame 5 causes the potential energy generated during compression to be converted into the kinetic energy of part of the support frame 5 structure. At this time, the support frame 5 changes to an expansion working state.

[0070] The support frame 5 is divided into two main categories. The first category consists of structures where the support frame 5 exhibits local axial displacement during the transition between working states. For example, when the support frame 5 is positioned around the inner conduit 1, if the front end of the support frame 5 is farther away from the rear end, the radial distance between the outer edge of the middle section of the support frame 5 and the inner conduit 1 decreases, indicating that the support frame 5 is in a contracted working state, retracting around the inner conduit 1. Conversely, when the front end of the support frame 5 is closer to the rear end, the radial distance between the outer edge of the middle section of the support frame 5 and the inner conduit 1 increases, indicating that the support frame 5 is in an expanded working state. However, in certain modified support frames (e.g., ... Figure 22-1When the inner support rod 24 is transformed into a semi-circle with an arc greater than 180 degrees, and the front end of the support frame 5 is closer to the rear end of the support frame 5, the distance between the outer edge of the middle section of the support frame 5 and the inner conduit 1 decreases radially, meaning the support frame 5 is in a contracted working state, and at this time the support frame 5 is contracted around the inner conduit 1; when the front end of the support frame 5 is farther from the rear end of the support frame 5, the distance between the outer edge of the middle section of the support frame 5 and the inner conduit 1 increases radially, and the support frame 5 is in an expanded working state. When the support frame 5 is arranged around the middle conduit 2, the above description of the support frame 5 can also be referred to. Therefore, in this invention, the front end and the rear end of the support frame 5 refer to the ends of the support frame 5 that are close to or in contact with the inner conduit 1 or the middle conduit 2. In some cases, the front end of the support frame is also the front connecting ring 12, and the rear end of the support frame is also the rear connecting ring 13. In this case, the structures that undergo axial displacement are the front connecting ring 12 and the rear connecting ring 13. The front connecting ring 12 and / or the rear connecting ring 13 can be integrally formed with the support frame 5, in which case the front connecting ring 12 and / or the rear connecting ring 13 are part of the support frame 5; of course, the front connecting ring 12 and / or the rear connecting ring 13 can also be external components connected to the support frame 5 by means of pivot connection or fixed connection, etc.

[0071] The second major category of support frame 5 is: the inner side of the support frame 5 does not have relatively movable ends. For example, the inner side of the support frame 5 is fixedly connected to the middle conduit 2 or at least does not undergo axial displacement. This type of support frame 5 does not have two relatively movable ends that contact the inner conduit 1 or the outer conduit 3, and only relies on the outer side of the support frame 5 to radially approach or radially move away from the middle conduit 2 to form a contraction working state or an expansion working state. For example... Figure 35-1 , Figure 35-2 , Figure 36-1 , 36-2 As shown.

[0072] Therefore, the supporting frame referred to in this invention includes, but is not limited to, the structures expressed in the various embodiments of this invention.

[0073] The device for ablation therapy of the digestive tract also includes an actuator connected to the rotating component, which drives the rotating component to rotate relative to the reference component. In some embodiments, of the two components, the middle catheter 2 and the outer catheter 3, one component (e.g., the outer catheter 3) is defined as the reference component, and the other component (e.g., the middle catheter 2) is defined as the rotating component. The defined rotating component is rotatably disposed relative to the defined reference component. The actuator is connected to the support frame 5 via the middle catheter 2. The rotation of the actuator directly drives the rotation of the middle catheter 2, which in turn drives the rotation of the support frame 5. Consequently, the inner end 8 of the electrode membrane wrapped around the outside of the support frame 5 also rotates, causing a change in the diameter of the electrode membrane 6. The actuator drives the inner end 8 of the electrode membrane to rotate, reducing the frictional resistance of the surrounding tissue to the electrode membrane 6. The actuator is easy to drive and will not damage the inner wall of the digestive tract. The actuator and the scheme of using a driver to drive the rotating component can adopt existing schemes in the prior art.

[0074] In other embodiments, the actuator is connected to the connector via an outer conduit 3. The rotation of the actuator can directly drive the outer conduit 3 to rotate, which in turn drives the outer end 9 of the electrode membrane to rotate via the connector, thus changing the diameter of the electrode membrane 6. The actuator effectively drives the outer end 9 of the electrode membrane to rotate directly, making the actuator's operation less strenuous.

[0075] See Figures 1 to 29-3 This embodiment provides a device for ablation therapy of the digestive tract, which includes: In some variations, the elongated inner catheter 1 is an elongated tubular component with an axial guidewire lumen 30 for the passage of the guidewire during surgery. A slender middle conduit 2 is sleeved on an inner conduit 1, and the middle conduit 2 is rotatably arranged relative to the inner conduit 1, with the inner conduit 1 serving as the axis of rotation of the middle conduit 2. The slender outer conduit 3 is sleeved on the middle conduit 2, and the middle conduit 2 is rotatably arranged relative to the outer conduit 3. The outer conduit 3 is fixed relative to the inner conduit 1. When the middle conduit 2 rotates relative to the inner conduit 1, the middle conduit 2 also rotates inside the outer conduit 3. In some embodiments, the middle conduit 2 is defined as a rotating component, and the outer conduit 3 is defined as a reference component. The rotating component is rotatably disposed relative to the reference component, and the connection relationship between the outer conduit 3 and the middle conduit 2, and the connection relationship between the outer conduit 3 and the inner conduit 1, are not limited. In some embodiments, the outer conduit 3 and the inner conduit 1 are fixedly connected. Therefore, the middle conduit 2 is rotatably disposed relative to the outer conduit 3, and in this case, the outer conduit 3 can also be regarded as the reference component.

[0076] The expandable component 4 surrounds the inner conduit 1. The expandable component 4 includes a support frame 5 and a flexible electrode membrane 6. The expandable component 4 has a radially shrinking contraction working state and a radially enlarging expansion working state. The rear end of the support frame 5 is connected to the front end of the middle conduit 2. Figures 1 to 8 The image shows the support frame 5 of Embodiment 1. Figures 13 to 20 This illustrates the support frame 5 of Embodiment 2. In embodiments with two support frames 5, the rear end of the support frame 5 is directly and fixedly connected to the front end of the central conduit 2. However, in some variations, a connection structure other than the third connection structure described above can be used. When using the first connection structure (e.g.) Figures 22-1 to 22-3 As shown in the diagram, the axis of the pivot should be spatially perpendicular to the inner conduit 1. This is so that when the middle conduit 2 rotates relative to the inner conduit 1, the middle conduit 2 causes the supporting frame 5 to rotate (or rotate synchronously) as well, allowing the supporting frame 5 to rotate around the inner conduit 1. When the front end of the supporting frame 5 is far away from the rear end, the radial distance between the middle section of the supporting frame 5 and the inner conduit 1 decreases, meaning the supporting frame 5 is in a contracted working state, retracting around the inner conduit 1. When the front end of the supporting frame 5 is close to the rear end, the radial distance between the middle section of the supporting frame 5 and the inner conduit 1 increases, meaning the supporting frame 5 is in an expanding working state. In this invention, the expanding working state of the supporting frame 5 refers to the supporting frame 5 expanding radially outward from the inner conduit 1. The supporting frame 5 shown in this invention is only a partial embodiment; some modified structures can also be used as the supporting frame in this invention.

[0077] In some embodiments, the deformable component of the support frame 5 during the transition between the contracted and expanded working states is made of a shape memory alloy, stainless steel, or an elastic plastic. Examples include shape memory alloys such as elastic nickel-titanium alloys, elastic stainless steel, and elastic plastics (e.g., certain hard plastics with good elasticity and non-toxic to humans). The deformable component can be integrally formed with the support frame 5, in which case it is a part of the support frame 5. In some embodiments, the deformable component can be a separate component connected to the support frame 5, such as a torsion spring. The deformable component is a component of the support frame 5 whose shape changes between the two working states, for example... Figure 14 The shapes of the inner support rod 24 and the middle support rod 25 have changed; for example... Figure 4In the middle, the shape of the inner support rod 24 is changed. The shape of the support frame 5 in the expansion working state is the preset shape of the corresponding material of the deformable part (such as the shape memory alloy material). The shape memory makes the support frame 5 always have a radially outward elastic force to transition from the contraction working state to the expansion working state, so that the support frame 5 always applies a radially outward elastic force to the electrode film 6.

[0078] As the rotating conduit 2 drives the supporting frame 5 to rotate relative to the outer conduit 3 with the inner conduit 1 as the rotation axis, the outer end 9 of the electrode membrane is positioned in the front-back direction by the connection of the connector and is only allowed to move radially. That is, the outer end 9 of the electrode membrane is positioned in the front-back direction but is set to move radially. The inner end 8 of the electrode membrane rotates around the inner conduit 1 under the drive of the supporting frame 5, and the total number of turns of the electrode membrane 6 gradually decreases. Correspondingly, each turn of the electrode membrane 6 is stretched open by the radially outward elastic force of the supporting frame 5. Therefore, the preset memory shape causes the supporting frame 5 to switch from a contracted working state to an expanded working state, and the diameter of the electrode membrane 6 gradually expands and increases. The expandable component 4... Figure 2 State transition Figure 4 The state, or the expandable component 4 is composed of Figure 16 State transition Figure 14 The state.

[0079] As the rotating conduit 2 drives the supporting frame 5 to rotate in the opposite direction to the outer conduit 3 with the inner conduit 1 as the rotation axis, the total number of turns of the electrode membrane 6 gradually increases, and the diameter of the electrode membrane 6 gradually shrinks. The electrode membrane 6 applies a radially inward force to the supporting frame 5. This force overcomes the elastic force of the preset memory shape, causing the supporting frame 5 to switch from the expansion working state to the contraction working state.

[0080] Therefore, regardless of whether the supporting frame 5 is in a contracted working state, an expanded working state, or during the transition between the two working states, the electrode membrane 6 always tightly grips the supporting frame 5, ensuring that the innermost ring of the electrode membrane 6 is always firmly attached to the supporting frame 5, and that adjacent rings of the electrode membrane 6 are also always firmly attached to each other. Depending on the different diameters of the patient's intestine, the supporting frame 5 can support electrode membranes 6 of different diameters in both partially expanded and fully expanded working states, allowing the outermost ring of the electrode membrane 6 to expand and adhere tightly to the inner wall of the intestine. Under the action of the pulse signal from the signal generator 31, the discharge of the electrode 7 can accurately ablate the villi of the intestinal wall.

[0081] See Figure 4 or Figure 14The front end of the support frame 5 is a front connecting ring 12, which is slidably and rotatably fitted onto the inner conduit 1 in the front-back direction. When the support frame 5 transitions from a contracted working state to an expanded working state, the front connecting ring 12 rotates around the inner conduit 1 and slides backward along the inner conduit 1. In some modified structures, the front connecting ring 12 is pivotally connected to the front middle part of the support frame 5, and the front connecting ring 12 is slidably and rotatably fitted onto the inner conduit 1 in the front-back direction (not shown). The rear end of the support frame 5 is a rear connecting ring 13, which is fitted onto the inner conduit 1 and fixedly connected to the middle conduit 2. The middle conduit 2 is used to drive the support frame 5 to rotate, but the middle conduit 2 can only rotate relative to the inner conduit 1 and cannot move in the front-back direction relative to the inner conduit 1. In some modified structures, the rear connecting ring 13 is omitted, and the rear end of the support frame 5 is directly fixedly connected to the middle conduit 2. In some variant structures, the rear central pivot of the supporting frame 5 is on the rear connecting ring 13 (not shown), and the rear connecting ring 13 is then fixedly connected to the central conduit 2. In some embodiments, the front connecting ring 12 and / or the rear connecting ring 13 are rings with a through hole in the middle, which are fully enclosed or not fully enclosed structures. They can also be structures with two states: an open, ready-to-install state (in which case the ring has an opening, which facilitates the installation of the ring to the outside of a component such as the inner conduit 1) and a closed or semi-closed installation state (in which case the opening of the ring is basically closed, and the ring is held to the outside of a component such as the inner conduit 1).

[0082] When the support frame 5 contracts or expands, the inner end 8 of the electrode membrane, being fixed to the support frame 5, rotates around the inner conduit 1 along with the support frame 5. The connector is connected to the outer conduit 3. When the outer conduit 3 is fixedly connected to the inner conduit 1, there is no relative movement between them. Therefore, the connector prevents the outer end 9 of the electrode membrane from rotating around the inner conduit 1. However, since the diameter of the electrode membrane 6 always matches the support frame 5, the connector also allows the outer end 9 of the electrode membrane to move radially. See also Figure 14 The connector includes an outer end rod 14 and an integral strip-shaped connecting strip 15 that is fixedly or rotatably connected to the rear end of the outer end rod 14. The rear end of the connecting strip 15 is connected to the front end of the outer conduit 3. The connection structure excludes a third connection structure. The outer end rod 14 is fixedly or rotatably connected to the outer end 9 of the electrode membrane. The connecting strip 15 is used to prevent (or prevent, as will be the case hereafter) the outer end rod 14 from rotating around the inner conduit 1 and / or the middle conduit 2.

[0083] In some variant structures, reference Figure 22-4 and Figure 23The connector includes an outer end rod 14 and a connecting strip 15 connected to the front end of the outer end rod 14. The front end of the connecting strip 15 is connected to the front of the inner conduit 1. The outer end rod 14 is fixedly or rotatably connected to the outer end 9 of the electrode membrane. The front end of the connecting strip 15 has a groove extending in the front-rear direction (not shown in the figure) and engages with a first axial rib 46 on the inner conduit 1, allowing the front end of the connecting strip 15 to slide in the front-rear direction of the inner conduit 1 but preventing rotation in the relative circumferential direction. In some variations, the front end of the connecting strip 15 may also be fixedly connected to the inner conduit 1 or pivotally connected, but the pivot should be perpendicular to the inner conduit 1.

[0084] See Figure 29-1 In a preferred embodiment, the connector includes an outer end rod 14, a front connecting strip 15 connected to the front end of the outer end rod 14, and a rear connecting strip 15 connected to the rear end of the outer end rod 14. The front end of the front connecting strip 15 is connected to the inner conduit 1, and the rear end of the rear connecting strip 15 is connected to the outer conduit 3. The connecting strip 15 is axially and non-rotatably connected to the inner conduit 1 or the outer conduit 3. In this embodiment, the connection between the connecting strip 15 and the inner conduit 1 or the outer conduit 3 is a connection structure other than the third type of connection structure. The outer end rod 14 is fixedly or rotatably connected to the outer end 9 of the electrode membrane. That is, the connector connects the outer end 9 of the electrode membrane, the inner conduit 1, and the outer conduit 3, which can make the outer end 9 of the electrode membrane subjected to balanced forces in the front-back direction. It will not be twisted due to the force because only one end of the outer end rod 14 is connected to the inner conduit 1 or the outer conduit 3, ensuring that the outer end rod 14 is always approximately parallel to the inner conduit 1, and the outer end rod 14 will not move in the front-back direction.

[0085] During the transition of the support frame 5 from the contracted working state to the expanded working state, as the diameter of each ring of electrode membrane 6 increases, the outer end rod 14 gradually moves away from the inner conduit 1. During the transition of the support frame 5 from the expanded working state to the contracted working state, as the diameter of each ring of electrode membrane 6 decreases, the outer end rod 14 gradually moves closer to the inner conduit 1, and the outer end rod 14 is always approximately parallel to the inner conduit 1.

[0086] When the support frame 5 changes between the contracted and expanded working states, the straight-line distance between the rear end of the connecting strip 15 and the rear connecting ring 13, acting as the leg of a virtual right triangle, remains constant. The straight-line distance between the outer end 9 of the electrode film and the rear connecting ring 13, also acting as the other leg of a virtual right triangle, changes. The distance between the rear end and the front end of the connecting strip 15, acting as the hypotenuse of a virtual right triangle, also changes. When the support frame 5 is in the contracted working state, the hypotenuse shortens; when the support frame 5 is in the expanded working state, the hypotenuse length increases. To accommodate this change, in some variant structures, the connecting strip 15 is a rigid elastic sheet capable of elastic bending (see...). Figure 29-2 The rear end of the rigid elastic sheet is fixed (or pivotally) connected to the outer guide tube 3, and the front end of the rigid elastic sheet is fixed (or pivotally) connected to the rear end of the outer end rod 14. When the support frame 5 is in the contracted working state, the rigid elastic sheet is bent inward or outward. When the support frame 5 is in the expanded working state, the rigid elastic sheet is straight. However, some bending is also acceptable (i.e., basically straight) so as to simplify the structure and reduce interference to the outside of the device when in the expanded working state.

[0087] In some variant structures, such as Figure 4 As shown, the connecting bar 15 includes multiple sections (two or more, for example, two sections) of rod 17. The front end of the adjacent subsequent rod 17 is pivotally connected to the rear end of the preceding rod 17 to form a chain. The front end of the foremost rod 17 is pivotally connected to the rear end of the outer rod 14. The rear end of the last rod 17 is pivotally connected to the outer conduit 3. The axis of each pivot is perpendicular to the inner conduit 1 in space. When the support frame 5 is in the contracted working state, the connecting bar 15 is bent inward or outward. When the support frame 5 is in the expanded working state, the connecting bar 15 is generally straight.

[0088] In some variant structures (such as) Figure 29-3 As shown), the connecting bar 15 includes multiple sections (two or more, such as three sections) of rod 17. Adjacent sections of rod 17 are slidably connected to form a telescopic rod, allowing for extension and retraction between adjacent sections of rod 17. The front end of the first section of rod 17 is pivotally connected to the rear end of the outer end rod 14, and the rear end of the last section of rod 17 is pivotally connected to the outer conduit 3. The axis of each pivot is spatially perpendicular to the inner conduit 1. Specifically, Figure 29-3In the middle section 17, there is a first guide groove 37 and a second guide groove 38. Two adjacent sections 17 each have a long strip of guide protrusion (not shown in the figure). The long strips of guide protrusion on the two adjacent sections 17 are respectively inserted into the first guide groove 37 and the second guide groove 38 to form a sliding connection.

[0089] If the connecting strip 15 is at least partially (e.g., at the connection with the inner conduit 1 or the connection with the outer conduit 3) selected as a rigid rod, then the connecting strip 15 can also be connected to the inner conduit 1 or the outer conduit 3. In this case, an axially extending rib or guide groove (e.g., extending in the front-to-back direction) needs to be provided on the inner conduit 1 or the outer conduit 3. Figure 29-1 In the middle, the first axial protrusion 46 on the inner guide tube 1 is provided with a guide block that cooperates with the first axial protrusion 46. The guide block can only slide along the front and back direction of the first axial protrusion 46 but cannot rotate. One end of the rigid rod is pivotally connected to the guide block.

[0090] See Figures 22-1 to 22-3 A modified structure of the support frame in Embodiment 1, wherein the front middle part of the support frame 5 is rotatably connected to a front connecting ring 12 via a pivot 18, and the rear middle part of the support frame 5 is rotatably connected to a rear connecting ring 13 via a pivot 18. Figures 22-1 to 22-3 In the middle, the inner support frame 19 includes multiple inner support rods 24. The front end of each inner support rod 24 is rotatably connected to the front connecting ring 12 via a pivot 18, and the rear end of each inner support rod 24 is rotatably connected to the rear connecting ring 13 via a pivot 18. Each pivot 18 is spatially perpendicular to the inner conduit 1 or the middle conduit 2.

[0091] Similarly, Figure 14 The modified structure of the support frame embodiment 2 shown (not illustrated) can be referenced to the modified structure of the support frame embodiment 1 described above. The front middle portion of the support frame 5 is rotatably connected to a front connecting ring 12 via a pivot 18, and the rear middle portion of the support frame 5 is rotatably connected to a rear connecting ring 13 via a pivot 18. Specifically, the inner support frame 19 includes multiple inner support rods 24. The front end of each inner support rod 24 is rotatably connected to the front connecting ring 12 via a pivot 18, and the rear end of each inner support rod 24 is rotatably connected to the rear connecting ring 13 via a pivot 18. Each pivot 18 is spatially perpendicular to the inner conduit 1 or the middle conduit 2.

[0092] In summary, in some embodiments, the support frame 5 deforms when it changes between a contracted working state and an expanded working state (e.g., Figure 8The inner support rod 24 (at its bend) is made of a rigid elastic material (i.e., a rigid material with elasticity, such as titanium-nickel alloy or stainless steel). This rigid elastic material gives the support frame 5 a radially outward elastic force that allows it to change from a contracted working state to an expanded working state. The electrode membrane 6 is provided with multiple electrodes 7 for receiving electrical signals. The electrode membrane 6 is wound around the support frame 5; preferably, the electrode membrane 6 is wound in a spiral shape around the support frame 5. The inner end 8 of the electrode membrane is fixedly connected to the support frame 5. The outer end 9 of the electrode membrane is connected to the outer conduit 3 via a connector. In some variations, for example… Figure 22-4 The outer end 9 of the electrode membrane is connected to the front part of the inner catheter 1 via a connector. In some variations, for example... Figure 29-1 The outer end 9 of the electrode membrane is connected to both the front of the outer conduit 3 and the front of the inner conduit 1 via a connector, which can prevent the outer end 9 of the electrode membrane from twisting and moving in the front and back directions.

[0093] refer to Figure 1 The actuator is an operating handle 28, which is connected to the middle conduit 2 and / or the outer conduit 3, and can also be connected to the inner conduit 1. The actuator is used to drive the middle conduit 2 and / or the outer conduit 3, so that the middle conduit 2 rotates in the forward direction relative to the outer conduit 3. The middle conduit 2 drives the support frame 5 to rotate in the forward direction, so that the electrode membrane 6 expands radially, and the support frame 5 also expands radially under the action of the rigid elastic material. The actuator is also used to drive the middle conduit 2 and / or the outer conduit 3, so that the middle conduit 2 rotates in the opposite direction relative to the outer conduit 3. The electrode membrane 6 contracts radially, and the electrode membrane 6 compresses and tightens the support frame 5 to contract radially.

[0094] In some modified structures, the actuator is connected to the middle catheter 2 and is used to drive the support frame 5 to rotate relative to the outer catheter 3 when the middle catheter 2 rotates relative to the outer catheter 3. The inner end 8 of the electrode membrane on the support frame 5 rotates relative to the outer end 9 of the electrode membrane. In the human digestive tract, when the electrode membrane 6 expands or contracts, the outermost electrode membrane 6 moves radially but does not rotate, which is less likely to damage the intestinal wall and reduces the resistance encountered during expansion or contraction, making operation more convenient.

[0095] The structure of an actuator will now be described with reference to the figures. One embodiment is shown below. Figure 1 , Figure 9 and Figure 21 , Figure 37-1 , Figure 37-3 The actuator includes an internal gear 10, an intermediate gear 11, and a knob 34, all of which are rotating components. The middle guide tube 2 is fixedly connected to the rotating component on the operating handle 28. This rotating component is rotatable relative to the operating handle body 35. Since both the inner guide tube 1 and the outer guide tube 3 are fixedly connected to the operating handle body 35, the rotating component can drive the middle guide tube 2 to rotate relative to the outer guide tube 3. Figure 9Inside the operating handle 28, the rotating component is an internal gear 10, which is limited in the front-to-back direction by the operating handle body 35. Therefore, the inner guide tube 1 and the middle guide tube 2 are relatively fixed in position in the front-to-back direction, as are the outer guide tube 3 and the middle guide tube 2, and the inner guide tube 1 and the outer guide tube 3. See also Figure 9 and Figure 21 The inner conduit 1 is fixedly connected to the operating handle body 35, and the outer conduit 3 is also fixedly connected to the operating handle body 35. A knob 34 is rotatably connected to the operating handle body 35. The inner wall of the knob 34 has an internal gear ring 16. An internal gear 10 is pivotally connected to the operating handle body 35, and the internal gear 10 is fixedly connected to the middle conduit 2. Two intermediate gears 11, pivotally connected to the operating handle body 35, are meshed on the internal gear 10. The intermediate gears 11 mesh with the internal gear ring 16. Rotation of the knob 34 drives the internal gear 10 to rotate, thereby causing the middle conduit 2 to rotate relative to the handle body 35. As mentioned earlier, since both the inner conduit 1 and the outer conduit 3 are fixedly connected to the operating handle body 35, the middle conduit 2 also rotates relative to the inner conduit 1 and the outer conduit 3.

[0096] In some modified structures, the middle conduit 2, serving as a rotating component, and the outer conduit 3, serving as a reference component, are rotatably arranged relative to the reference component. The component that is actively rotated is the outer conduit 3, which serves as the reference component. In this case, an actuator is connected to the outer conduit 3 to drive the connector to rotate around the support frame 5 when the outer conduit 3 rotates relative to the middle conduit 2. The outer end 9 of the electrode membrane on the support frame 5 rotates relative to the inner end 8 of the electrode membrane, thereby controlling the expansion or contraction of the support frame 5. In the human digestive tract, when the electrode membrane 6 expands or contracts, the outermost electrode membrane 6 moves radially and rotates around the support frame 5. When the electrode membrane 6 rotates, the friction generated by its contact with the inner wall of the intestine requires an increase in the driving force of the actuator, as well as the elastic force of the rigid elastic material (or deformable component).

[0097] Specifically, when the actuator drives the outer conduit 3 to rotate in the opposite direction relative to the middle conduit 2, the outer conduit 3 drives the outer end 9 of the connector and electrode membrane to rotate in the opposite direction, causing the electrode membrane 6 to expand radially while the supporting frame 5 also expands radially under the action of the elastic material; when the actuator drives the outer conduit 3 to rotate in the forward direction relative to the middle conduit 2, the outer conduit 3 drives the outer end 9 of the connector and electrode membrane to rotate in the forward direction, causing the electrode membrane 6 to contract radially while simultaneously compressing and tightening the supporting frame 5 in a radial contraction. See also Figures 24-26The tail of the inner conduit 1 is fixedly connected to the rear end of the operating handle body 35. The middle conduit 2 is fixedly connected to the knob 34 and can be driven to rotate by the knob 34. A first bevel gear 39 is also coaxially fixed on the middle conduit 2. The first bevel gear 39 meshes with the second bevel gear 40. The second bevel gear 40 meshes with the third bevel gear 41. An outer conduit 3 is coaxially fixed on the third bevel gear 41. The rotation direction of the third bevel gear 41 is opposite to the rotation direction of the first bevel gear 39, so that when the knob 34 drives the middle conduit 2 to rotate, the outer conduit 3 also rotates in the opposite direction at the same time.

[0098] In some modified structures, the inner catheter 1 and the middle catheter 2 are positioned relatively fixed in the front-to-back direction, but relative rotation between them is permitted; that is, the inner catheter 1 is rotatably positioned relative to the middle catheter 2. (Corresponding structural reference) Figure 5 and Figure 21 ,or Figure 25 and Figure 26 Within the operating handle 28, the inner conduit 1 is fixed to the operating handle body 35, and the middle conduit 2 is fixed to a rotating component within the operating handle 28. The rotating component is limited by a limiting component and cannot move in the front-to-back direction. In some variant structures, a radially inward annular protrusion 42 may be provided on the inner wall of the middle conduit 2, which inserts into a radially inward annular recessed groove on the outer wall of the inner conduit 1. In some variant structures, a radially outward annular recessed groove may be provided on the inner wall of the middle conduit 2, and a radially outward annular protrusion 42 may be provided on the outer wall of the inner conduit 1, which inserts into the recessed groove.

[0099] In some modified structures, the outer conduit 3 and the middle conduit 2 are positioned relatively fixed in the front-back direction, but the middle conduit 2 and the outer conduit 3 are allowed to rotate relative to each other (i.e., the middle conduit 2 is rotatably positioned relative to the outer conduit 3). The corresponding structural reference is... Figure 5 and Figure 21 Within the operating handle 28, the outer conduit 3 is fixed to the operating handle body 35, and the middle conduit 2 is fixed to a rotating component within the operating handle 28. The rotating component is limited by a limiting component and cannot move in the front-to-back direction. In some variant structures, a radially inward annular protrusion 42 may be provided on the inner wall of the outer conduit 3, which inserts into a radially inward annular recessed groove on the outer wall of the middle conduit 2. In some variant structures, a radially outward annular recessed groove may be provided on the inner wall of the outer conduit 3, and a radially outward annular protrusion 42 may be provided on the outer wall of the middle conduit 2, which inserts into the recessed groove. In some variant structures, refer to... Figure 25 and Figure 26 The outer catheter 3 is restricted by the first limiting member 44 and cannot move relative to the middle catheter 2 in the front-back direction. The middle catheter 2 is restricted by the second limiting member 45 and cannot move relative to the outer catheter 3 in the front-back direction.

[0100] In some variant structures, see Figure 27 and Figure 28 The support frame 5 has a front end and a rear end. The front end is a front connecting ring 12, and the rear end is a rear connecting ring 13. The front connecting ring 12 is sleeved on the inner conduit 1 and is rotatably and positionally positioned on the inner conduit 1 in the front-rear direction. Specifically, the front part of the inner conduit 1 has a radially outward annular protrusion 42, which is inserted into the annular groove of the front connecting ring 12. The rear connecting ring 13 is sleeved on the middle conduit 2, and the rear end of the support frame and the middle conduit 2 are slidably arranged in the front-rear direction but are prohibited from relative rotation. Specifically, the middle conduit 2 has a second axial rib 47 extending in the front-rear direction, which protrudes radially outward. The rear connecting ring 13 has a guide groove extending in the front-rear direction, and the second axial rib 47 is inserted into the guide groove. When the middle conduit 2 rotates, it drives the supporting frame 5 to rotate. The front connecting ring 12 rotates relative to the inner conduit 1 without sliding axially. The rear connecting ring 13 rotates along with the middle conduit 2 and slides axially on the middle conduit 2. The rear connecting ring 13 slides relative to the middle conduit 2 without rotating.

[0101] In some modified structures (not shown), the support frame 5 has a front end and a rear end. The front end of the support frame is sleeved on the inner conduit 1. The front end of the support frame is a movable end that is movable relative to the inner conduit 1 in both the front-back direction and the circumferential direction. The rear end of the support frame 5 is connected to the middle conduit 2. The rear end of the support frame 5 and the middle conduit 2 are slidably but non-rotatable in the front-back direction.

[0102] See Figure 4 , Figure 22-4 , Figure 27One embodiment of the support frame 5 includes an inner support frame 19 and multiple outer support rods 20. The front end of the inner support frame 19 is a front connecting ring 12, which is slidably fitted onto the inner conduit 1 in the front-back direction. The rear end of the inner support frame 19 is a rear connecting ring 13, which is fitted onto the inner conduit 1 and fixedly connected to the middle conduit 2. When the support frame 5 is in the expanded working state, the middle section of the inner support frame 19 is radially away from the inner conduit 1. When the support frame 5 is in the contracted working state, the inner support frame 19... The middle section of the inner support frame 19 is radially close to the inner conduit 1. Multiple outer support rods 20, parallel to the inner conduit 1, are fixedly connected to the middle section of the inner support frame 19. These outer support rods 20 are arranged in a cylindrical, spaced-apart pattern around the inner support frame 19. Each outer support rod 20 has a forward extension 21 extending forward of the middle section of the inner support frame 19, and / or a rearward extension 22 extending backward of the middle section of the inner support frame 19, such that the length of the outer support rod 20 in the front-back direction is greater than the length of the middle section of the inner support frame 19 in the front-back direction. In some variant structures, the length of the electrode film 6 in the front-back direction is greater than or equal to the length of the outer support rod 20 in the front-back direction; optionally, the length difference between the two is less than 30 mm, preferably less than 2 mm. In some variant structures, there are 5-12 outer support rods 20. The outer support rod 20 supports the electrode membrane 6. The length of the outer support rod 20 in the front-back direction is greater than the length of the middle section of the inner support frame 19 in the front-back direction. This can greatly shorten the length of the middle section of the inner support frame 19 in the front-back direction. Compared with the prior art where the electrode membrane 6 is directly connected to the middle section of the inner support frame 19, the length of the support frame 5 in the front-back direction in the contracted state of this embodiment is smaller.

[0103] Because the contractile support frame 5 is a rigid component in the radial direction and cannot be bent radially, while other components, such as the anterior guide cap 29 and the posterior guide cap 32, are made of rubber or silicone and are soft and flexible, and the inner catheter 1, middle catheter 2, and outer catheter 3 are slender components that can be bent radially to a certain extent, the shorter the length of the support frame 5 in the anterior-posterior direction, the easier it is to pass through the curved digestive tract without damaging the inner wall of the digestive tract. With the electrode membrane 6 of the same length in the anterior-posterior direction, the setting of the outer support rod 20 makes the support frame 5 shorter in the anterior-posterior direction in the contractile working state compared to the expansion working state, thus greatly shortening the length of the contracted support frame 5 in the anterior-posterior direction, making it easier to pass through the curved digestive tract.

[0104] In some variant structures, such as Figure 4 As shown, when the support frame 5 is in the expanded working state, the length of the outer support rod 20 in the front-to-back direction is greater than or equal to the length of the inner support frame 19 in the front-to-back direction. Figure 4The two are of equal length), and the front end of the inner support frame 19 is located behind or aligned with the front end of the outer support rod 20, and the rear end of the inner support frame 19 is located in front of or aligned with the rear end of the outer support rod 20. Figure 4 (For alignment). The inner end 8 of the electrode membrane is connected to an outer support rod 20. In some variations, when the support frame 5 is in the retracted working state, the length of the outer support rod 20 in the front-rear direction is greater than or equal to the length of the inner support frame 19 in the front-rear direction (not shown).

[0105] An alternative variation is that the inner support frame 19 includes multiple inner support rods 24, see Figure 4 When the support frame 5 is in its expanded working state, the inner support rod 24 is arc-shaped with its opening facing the inner conduit 1. Each outer support rod 20 is fixedly connected to the middle section of the inner support rod 24, and the length of the outer support rod 20 is 1.5 to 12 times the length of the middle section of the inner support rod 24. See Figure 2 When the support frame 5 is in its retracted state, the inner support rod 24 is approximately straight. The inner support frame 19 is made of shape memory alloy, and when the support frame 5 is in its expanded state, the shape of the inner support frame 19 is the preset shape of the shape memory alloy. In some modified structures, when the length of the outer support rod 20 is much greater than the length of the middle section of the inner support rod 24, the length of the outer support rod 20 in the front-rear direction is also greater than the length of the inner support rod 24 in the front-rear direction when the support frame 5 is in its retracted state.

[0106] In some variations of Embodiment 1 of the support frame 5, for example, the front middle portion and / or the rear middle portion of the inner support rod 24 are pivotally connected to the front connecting ring 12 or the rear connecting ring 13, respectively, with the pivot perpendicular to the inner conduit 1.

[0107] See Figure 14The second embodiment of the support frame 5 is as follows: it includes an inner support frame 19, a middle support frame 23, and multiple outer support rods 20 parallel to the inner conduit 1. The front end of the inner support frame 19 is a front connecting ring 12 (i.e., the inner support frame 19 is fixedly connected to the front connecting ring 12 or integrally formed), and the front connecting ring 12 can be slidably sleeved on the inner conduit 1 in the front-back direction; the rear end of the inner support frame 19 is a rear connecting ring 13 (i.e., the inner support frame 19 is fixedly connected to the rear connecting ring 13 or integrally formed), and the rear connecting ring 13 is sleeved on the inner conduit 1 and fixedly connected to the middle conduit 2; when the support frame 5 is in the expanded working state, the middle section of the inner support frame 19 is radially away from the inner conduit 1, and when the support frame 5 is in the contracted working state, the middle section of the inner support frame 19 is radially close to the inner conduit 1. The middle section of the inner support frame 19 is fixedly connected to the middle support frame 23, which has two ends: a front end and a rear end. One of these ends is fixedly or pivotally connected to the outer support rod 20. Figure 14 The middle end is fixedly connected to the outer support rod 20, and the other end of the two ends is slidably connected to the outer support rod 20 in the front-back direction. Figure 14 The central support frame 23 has a front end that is slidably connected to the outer support rod 20 in the front-back direction via a sliding groove 33. Multiple outer support rods 20 are distributed in a cylindrical shape around the central support frame 23. In some modified structures, both ends are slidably connected to the outer support rods 20 in the front-back direction. In this case, when the support frame 5 expands or contracts, the electrode membrane 6 will not move in the front-back direction, which facilitates accurate positioning of the target tissue.

[0108] Regardless of whether the support frame 5 is in a contracted or expanded working state, the length of the outer support rod 20 in the front-to-back direction is greater than or equal to the length of the middle support frame 23 in the front-to-back direction.

[0109] In some variations, regardless of whether the support frame 5 is in a retracted or expanded working state, the outer support rod 20 has a front extension section 21 extending forward toward the front end of the central support frame 23, or / and the outer support rod 20 has a rear extension section 22 extending backward toward the rear end of the central support frame 23, such that the length of the outer support rod 20 in the front-rear direction is greater than the length of the central support frame 23 in the front-rear direction (not shown).

[0110] In some modified structures, regardless of whether the support frame 5 is in a contracted or expanded working state, the length of the outer support rod 20 in the front-to-back direction is greater than or equal to the length of the middle support frame 23 in the front-to-back direction, and the front end of the middle support frame 23 is located behind or aligned with the front end of the outer support rod 20, and the rear end of the middle support frame 23 is located in front of or aligned with the rear end of the outer support rod 20.

[0111] In some modified structures, regardless of whether the support frame 5 is in a contracted or expanded working state, the length of the outer support rod 20 in the front-to-back direction is greater than or equal to the length of the inner support frame 19 in the front-to-back direction, and the front end of the inner support frame 19 is located behind or aligned with the front end of the outer support rod 20, and the rear end of the inner support frame 19 is located in front of or aligned with the rear end of the outer support rod 20.

[0112] In some modified structures, regardless of whether the support frame 5 is in a contracted or expanded working state, the length of the middle support frame 23 in the front-to-back direction is greater than or equal to the length of the inner support frame 19 in the front-to-back direction, and the front end of the inner support frame 19 is located behind or aligned with the front end of the middle support frame 23, and the rear end of the inner support frame 19 is located in front of or aligned with the rear end of the middle support frame 23.

[0113] In the second embodiment of the support frame 5, the inner support frame 19 and the middle support frame 23 are connected in two stages. In this second embodiment of the support frame 5, the length of the outer support rod 20 in the front-back direction is the maximum length of the support frame 5 in the front-back direction, which makes it easier for the support frame 5 of this embodiment to pass through the digestive tract in the contracted state.

[0114] In some variant structures, see Figure 14 The inner support frame 19 includes multiple inner support rods 24. When the support frame 5 is in the expanded working state, the inner support rods 24 are in an arc shape with their openings facing the inner conduit 1. The middle support frame 23 includes multiple middle support rods 25. When the support frame 5 is in the expanded working state, the middle support rods 25 are in an arc shape with their openings facing away from the inner conduit 1. The middle sections of each middle support rod 25 are fixedly connected to the middle sections of each inner support rod 24. When the support frame 5 is in the contracted working state, the middle support rods 25 and the inner support rods 24 are in a generally straight line shape.

[0115] In some variations of Embodiment 2 of the support frame 5, for example, the front end and / or the rear end of the inner support rod 24 are pivotally connected to the front connecting ring 12 or the rear connecting ring 13, respectively, with the pivot perpendicular to the inner conduit 1.

[0116] In the support frame 5 of Embodiment 1 and Embodiment 2, the middle section of the inner support rod 24 refers to the part of the inner support rod that is substantially parallel to the inner conduit 1 when the support frame 5 is in the expanded working state, and the middle section of the middle support rod 25 refers to the part of the middle support rod that is substantially parallel to the inner conduit 1 when the support frame 5 is in the expanded working state.

[0117] See Figure 14 and Figure 24In some modified structures, the middle support rod 25 has a front end 26 and a rear end 27. One end is fixedly or pivotally connected to the outer support rod 20, and the other end is slidably connected to the outer support rod 20 in the front-rear direction via a sliding groove 33. In some modified structures, both ends are slidably connected to the outer support rod 20 in the front-rear direction via sliding grooves 33.

[0118] In some variant structures, the outer support rod 20 has a front extension 21 extending forward toward the front end 26 of the middle support rod, and / or the outer support rod 20 has a rear extension 22 extending backward toward the rear end 27 of the middle support rod, such that the length of the outer support rod 20 in the front-rear direction is greater than the length of the middle support rod 25 in the front-rear direction (not shown).

[0119] In some modified structures, the length of the electrode film 6 in the front-back direction is greater than or equal to the length of the outer support rod 20 in the front-back direction. Optionally, the length difference between the two is less than 30 mm, preferably less than 2 mm. Optionally, there are 5-12 outer support rods 20.

[0120] In some modified structures, when the support frame 5 is in an expanded working state, the length of the outer support rod 20 in the front-rear direction is greater than or equal to the length of the inner support frame 19 in the front-rear direction, and the front end of the inner support frame 19 is located behind or aligned with the front end of the outer support rod 20, and the rear end of the inner support frame 19 is located in front of or aligned with the rear end of the outer support rod 20. The inner end portion 8 of the electrode film is connected to the outer support rod 20.

[0121] See Figures 22-1 to 22-3 A modified structure of the support frame in Embodiment 1, wherein the front middle part of the support frame 5 is rotatably connected to a front connecting ring 12 via a pivot 18, and the rear middle part of the support frame 5 is rotatably connected to a rear connecting ring 13 via a pivot 18. Figures 22-1 to 22-3 In the inner support frame 19, multiple inner support rods 24 are included. The front end of each inner support rod 24 is rotatably connected to the front connecting ring 12 via a pivot 18, and the rear end of each inner support rod 24 is rotatably connected to the rear connecting ring 13 via a pivot 18. Each pivot 18 is spatially perpendicular to the inner guide tube 1 or the middle guide tube 2. The inner support rods 24 and the outer support rods 20 are fixedly connected by rivets 36.

[0122] Similarly, Figure 14The second embodiment of the support frame shown can also have a variant structure (not shown). Referring to the variant structure of the first embodiment of the support frame described above, the front middle portion of the support frame 5 is rotatably connected to a front connecting ring 12 via a pivot 18, and the rear middle portion of the support frame 5 is rotatably connected to a rear connecting ring 13 via a pivot 18. Specifically, the inner support frame 19 includes multiple inner support rods 24. The front portion of each inner support rod 24 constitutes the front middle portion of the support frame 5 in this embodiment, and the rear portion of each inner support rod 24 constitutes the rear middle portion of the support frame 5 in this embodiment. The front ends of each inner support rod 24 are rotatably connected to the front connecting ring 12 via pivots 18, and the rear ends of each inner support rod 24 are rotatably connected to the rear connecting ring 13 via pivots 18. Each pivot 18 is spatially perpendicular to the inner conduit 1 or the middle conduit 2.

[0123] The inner support frame 19 and the middle support frame 23 are made of shape memory alloy materials (such as nickel-titanium alloy), stainless steel, certain hard plastics with good elasticity and non-toxic to the human body, etc. When the support frame 5 is in the expanded working state, the shape of the inner support frame 19 and the middle support frame 23 is the preset shape of the shape memory alloy, so that the inner support frame 19 can tend to return to the expanded working state when it is in the contracted working state.

[0124] In some variant structures, such as Figure 18 When the support frame 5 is in the retracted working state, the electrode film 6 is wound in multiple turns around the support frame 5; as Figure 17 When the supporting frame 5 is in the expanded working state, the number of turns of the electrode film 6 is greater than 1 turn and less than 2 turns.

[0125] In some variant structures, such as Figure 1 and 2 As shown, the inner catheter 1 is fixedly connected to a guide cap 29 at its tip. The inner catheter 1 is a tubular body with a guidewire lumen 30. The guide cap 29 also has a guidewire lumen 30 in its center, which communicates with the guidewire lumen 30 of the inner catheter 1. During the ablation procedure, a guidewire passes through the guidewire lumen 30. After the ablation device is inserted into the digestive tract at the target location, during the transition of the expandable component 4 from the contraction state to the expansion state, only the support frame 5 rotates under the drive of the middle catheter 2. The inner catheter 1, outer catheter 3, and guide cap 29 do not rotate, thus preventing damage to the inner wall of the digestive tract. After the ablation of the target tissue is completed, during the transition of the expandable component 4 from the expansion state to the contraction state, the outer catheter 3, inner catheter 1, and guide cap 29 do not rotate. The support frame 5 only rotates within the electrode membrane 6, again preventing damage to the inner wall of the digestive tract.

[0126] See Figure 4 , Figure 11In some variations, the support frame 5 includes an inner support frame 19 and multiple outer support rods 20 connected to the inner support frame 19. The outer support rods 20 are parallel to the middle conduit 2 and also parallel to the inner conduit 1. The multiple outer support rods 20 are distributed in a cylindrical shape around the inner support frame 19. The inner end 8 of the electrode film is connected to one of the outer support rods 20.

[0127] In some variations, the support frame 5 is made of elastic nickel-titanium alloy, elastic stainless steel, elastic plastic, etc.

[0128] exist Figure 14 In the support frame 5, the inner support frame 19 and the middle support frame 23 are made of nickel-titanium alloy, elastic stainless steel, elastic plastic, etc.

[0129] The selection requirements for the support frame 5 are as follows: when the front end of the support frame 5 is farther away from or closer to the rear end of the support frame 5, the support frame 5 is in a contracted working state or an expanded working state. That is, the outermost middle member of the support frame 5 is closer to or farther away from the inner conduit 1, and the outermost middle member of the support frame 5 is distributed in a cylindrical interval around the inner conduit 1. When the support frame 5 changes between the contracted and expanded working states, the shape of some individual members on the support frame 5 will change. These individual members have elastic force when compressed, and the elastic force makes the support frame 5 tend to change from the contracted working state to the expanded working state. In the contracted working state, these elastic members are compressed by the radial contraction force of the electrode film 6. When the electrode film 6 expands, the elastic force makes the support frame 5 enter the expanded working state. This invention only illustrates a portion of the support frame 5. The support frame referred to in this invention is not limited to the illustrated embodiment. Under the premise of meeting the above selection requirements, other unillustrated support frames based on the concept of this invention also belong to the support frame referred to in this invention.

[0130] See Figures 30 to 36-2 This embodiment provides another device for ablation treatment of the digestive tract, which includes: 2. Slender middle conduit; A slender outer conduit 3 is sleeved on the middle conduit 2, and the middle conduit 2 is rotatably disposed relative to the outer conduit 3; An expandable component 4 surrounds the central conduit 2. The expandable component 4 includes a support frame 5 and a flexible electrode membrane 6. The expandable component 4 has a radially decreasing contraction working state and a radially increasing expansion working state. The support frame 5 is connected to the central conduit 2. The deformable part of the support frame 5 when changing between the contraction and expansion working states is made of a rigid elastic material. The rigid elastic material gives the support frame 5 a radially outward elastic force when changing from the contraction working state to the expansion working state. The electrode membrane 6 is provided with multiple electrodes 7 for receiving electrical signals, including signals for heating target tissue, electric field ablation, radio frequency signals, etc., which can be pulse signals. The electrode membrane 6 is spirally wound on the support frame 5. The inner end 8 of the electrode membrane is connected to the support frame 5, and the outer end 9 of the electrode membrane is connected to the outer conduit 3 through a connector.

[0131] One option is that the actuator is an operating handle 28, the structure of which is described in [reference needed]. Figure 34 (Refer to its radial section diagram) Figure 21 It's just a matter of putting Figure 21 The inner conduit 1 is replaced by the middle conduit 2. The outer conduit 3 is fixedly connected to the operating handle body 35. The middle conduit 2 is fixedly connected to the internal gear 10, which is a rotating component. The knob 34 is rotatably mounted on the operating handle body 35 and drives the internal gear 10 to rotate via the intermediate gear 11, thereby causing the middle conduit 2 to rotate relative to the outer conduit 3. The knob 34 is restricted to rotating only relative to the operating handle body 35 and cannot move in the back-and-forth direction relative to the operating handle body 35. In some variant structures, the middle conduit 2 can also be directly fixed to the knob 34. When the knob 34 is turned, the middle guide tube 2 is driven to rotate, so that the middle guide tube 2 rotates in the forward direction relative to the outer guide tube 3, and the support frame 5 also rotates in the forward direction relative to the outer guide tube 3. The inner end 8 of the electrode membrane is also driven to rotate in the forward direction. At the same time, the electrode membrane 6 expands radially, and the support frame 5 also expands radially under the action of the rigid elastic material. The actuator is also used to drive the middle guide tube 2, so that the middle guide tube 2 rotates in the opposite direction relative to the outer guide tube 3. At the same time, the electrode membrane 6 contracts radially, and the electrode membrane 6 compresses and tightens the support frame 5 to contract radially.

[0132] In some variant structures, see Figure 35-1 , Figure 35-2 The device for ablation therapy of the digestive tract also includes an inner catheter 1, a middle catheter 2 sleeved on the inner catheter 1, and the middle catheter 2 rotatably disposed relative to the inner catheter 1. The inner catheter 1 and the outer catheter 3 are fixedly disposed together. A guide cap 29 is fixedly connected to the front end of the inner catheter 1. The inner catheter 1 is a tubular body with a guidewire lumen 30. The center of the guide cap 29 also has a guidewire lumen 30 and communicates with the guidewire lumen 30 of the inner catheter 1. The operating handle for the actuator to drive the rotation of the middle catheter 2 relative to the outer catheter 3 can be found in [reference needed]. Figure 9 and Figure 21Its working principle has been described above. Primarily, the internal gear 10, acting as a rotating component, is driven to rotate by the knob 34, which in turn causes the middle guide tube 2 to rotate relative to the inner guide tube 1 or the outer guide tube 3. The operating handle 28, which acts as the actuator, can also be found in [reference needed]. Figure 25 Its working principle has been described above. Knob 34 drives the middle conduit 2 to rotate simultaneously relative to the inner conduit 1 and the outer conduit 3.

[0133] See Figure 35-1 and Figure 35-2 The support frame 5 includes an inner support rod 24 and an outer support rod 20. The middle part of the inner support rod 24 is fixedly connected to the central guide tube 2. Both the front and rear ends of the inner support rod 24 are slidably connected to the outer support rod 20 via sliding grooves 33 on the outer support rod 20 in a front-rear direction (another structure not shown is where one end is slidably connected to the outer support rod 20 via the sliding grooves 33 in a front-rear direction, and the other end is fixed or pivotally connected to the outer support rod 20). When the support frame 5 is in the expanded working state, the inner support rod 24 is in an arc shape with its opening facing outwards; see [reference missing]. Figure 35-2 When the support frame 5 is in the contracted working state, the inner support rod 24 is compressed into a roughly straight shape by the electrode membrane 6. The structure of this support frame 5 ensures that regardless of whether the expandable component 4 is in the expanded or contracted working state, the outer support rod 20, as the longest rod in the front-back direction of the support frame 5, matches the electrode membrane 6. When the support frame 5 is in the contracted state, its shorter length makes it easier to pass through the curved digestive tract.

[0134] In some variant structures, see Figure 36-1 The support frame 5 includes an annular rod 50 and an outer support rod 20. The inner side of the annular rod 50 is fixedly connected to the middle guide tube 2, and the outer side of the annular rod 50 is fixedly connected to the outer support rod 20. When the support frame 5 is in the expanded working state, the annular rod is an open annular shape; when the support frame 5 is in the contracted working state, the annular rod is a flattened, roughly straight shape (see...). Figure 36-1 The structure of this support frame 5 ensures that, regardless of whether the expandable component 4 is in an expanded or contracted state, the outer support rod 20, as the longest member of the support frame 5 in the longitudinal direction, matches the electrode membrane 6. Therefore, when the support frame 5 is in the contracted state, its shorter length allows for easier passage through the curved digestive tract. Furthermore, when the support frame 5 transitions from a contracted to an expanded state, the outer support rod 20 and the electrode membrane 6 only move radially, without any longitudinal movement, facilitating accurate positioning and ablation of the target tissue by the physician.

[0135] In an embodiment of an ablation treatment device for the digestive tract including an inner catheter 1, a middle catheter 2, and an outer catheter 3, the connector includes an outer end rod 14 and a connecting strip 15 that is rigid in the circumferential direction. The outer end rod 14 is parallel to the inner catheter 1 and connected to the outer end 9 of the electrode membrane. One end of the connecting strip 15 is connected to the outer end rod 14, and the other end of the connecting strip 15 is connected to the outer catheter 3 and / or the inner catheter 1. During the transition of the support frame 5 from a contracted working state to an expanded working state, the outer end rod 14 gradually moves away from the inner catheter 1, and during the transition of the support frame 5 from an expanded working state to a contracted working state, the outer end rod 14 gradually moves closer to the inner catheter 1.

[0136] The connecting bar 15 and the outer end rod 14 are selected from the following three connection structures: pivot connection, fixed connection, and slidable connection in the front-back direction, wherein the pivot of the pivot connection is perpendicular to the inner conduit 1; the connecting bar 15 and the outer conduit 3 and / or the inner conduit 1 are selected from the following three connection structures: pivot connection, fixed connection, and slidable connection in the front-back direction, wherein the pivot of the pivot connection is perpendicular to the inner conduit 1.

[0137] In some variations, the distance between the front and rear ends of the connecting strip 15 can be variably set. For example, see... Figure 29-2 The connecting strip 15 is a rigid, flexible sheet that is radially elastic and can be bent. When the supporting frame 5 is in the retracted working state, the connecting strip 15 is bent. For example, see Figure 22-4 The connecting bar 15 includes multiple sections 17. The ends of two adjacent sections 17 are pivotally connected to form a chain. The inner conduit 1 is slidably connected to an adjacent section 17 in the front-back direction but is prohibited from rotating through the first axial rib 46. The outer end rod 14 is pivotally connected to an adjacent section 17. The axis of each pivot is perpendicular to the inner conduit 1 in space.

[0138] In some variations, see Figure 27 The connecting bar 15 includes multiple sections 17, with the ends of two adjacent sections 17 pivotally connected to form a chain. The outer conduit 3 is pivotally connected to an adjacent section 17, and the outer end rod 14 is pivotally connected to an adjacent section 17. The axis of each pivot is perpendicular to the inner conduit 1 in space.

[0139] In some variations, see Figure 29-3 The connecting bar 15 includes multiple sections of rod 17, which are slidably connected to form a telescopic rod. The outer end rod 14 is pivotally connected to the end of an adjacent section of rod 17. The outer conduit 3 (or / and the inner conduit 1) is pivotally connected to an adjacent section of rod 17. The axis of each pivot is perpendicular to the inner conduit 1 in space.

[0140] In some variations, see Figure 29-1The connecting strip 15 includes a connecting strip 15 located at the front of the outer end rod 14 and a connecting strip 15 located at the rear of the outer end rod 14; the rear end of the connecting strip 15 located at the front of the outer end rod 14 is connected to the front end of the outer end rod 14, and the front end of the connecting strip 15 located at the front of the outer end rod 14 is connected to the inner conduit 1; the front end of the connecting strip 15 located at the rear of the outer end rod 14 is connected to the rear end of the outer end rod 14, and the rear end of the connecting strip 15 located at the rear of the outer end rod 14 is connected to the outer conduit 3.

[0141] Some variant structures lack the inner catheter 1; see [link to relevant documentation]. Figure 30 and Figure 31 The support frame 5 has a front end (i.e., front connecting ring 12) and a rear end (i.e., rear connecting ring 13). The front end of the support frame 5 is sleeved on the middle guide tube 2. This end is a movable end relative to the middle guide tube 2 in the front-back direction and the circumferential direction. That is, the front end of the support frame 5 is movably set relative to the middle guide tube 2 in the front-back direction and the circumferential direction. The rear end of the support frame 5 is fixedly connected to the middle guide tube 2.

[0142] Some variant structures lack the inner catheter 1; see [link to relevant documentation]. Figure 32 and Figure 33 The support frame 5 has two ends: a front end (i.e., the front connecting ring 12) and a rear end (i.e., the rear connecting ring 13). Both ends of the support frame 5 are fitted onto the middle guide tube 2, and both ends are slidably connected to the middle guide tube 2 in the front-rear direction, while both ends are non-rotatably connected to the middle guide tube 2. Specifically, the middle guide tube 2 has a second axial rib 47, which extends in the front-rear direction and protrudes radially. The inner walls of the front connecting ring 12 and the rear connecting ring 13 both have radially recessed guide grooves, and the second axial rib 47 is inserted into the guide grooves. The middle guide tube 2 at the front of the front connecting ring 12 has a radially outwardly protruding front limit block 48, and the middle guide tube 2 at the rear of the rear connecting ring 13 has a radially outwardly protruding rear limit block 49. The front limit block 48 and the rear limit block 49 are used to limit the front limit position or the rear limit position of the support frame 5 relative to the middle guide tube 2 in the front-rear direction, respectively.

[0143] In some variant structures, the inner conduit 1 is not shown. The support frame 5 has two ends: the front end (i.e., the front connecting ring 12) and the rear end (i.e., the rear connecting ring 13). Both ends of the support frame 5 are sleeved on the middle conduit 2. One end is slidably connected to the middle conduit 2 in the front-back direction and is not rotatably connected to the middle conduit 2. The other end is a movable end that allows rotation in the circumferential direction and sliding in the front-back direction. That is, the other end is rotatable in the circumferential direction and slidable in the front-back direction relative to the middle conduit 2.

[0144] In some variant structures, the support frame 5 has a front end and a rear end. The rear end of the support frame is connected to the central conduit 2. The connection includes the three connection methods mentioned above, except for the third connection method. However, the pivot of the first connection method needs to be perpendicular to the central conduit 2. The front end of the support frame is suspended (not shown).

[0145] In some variant structures, see Figures 30 to 36-2 The connector includes an outer end rod 14 connected to the outer end of the electrode membrane and a connecting strip 15. One end of the connecting strip 15 is connected to the outer end rod 14, and the other end of the connecting strip 15 is connected to the outer conduit 3. When the support frame 5 changes between the contraction and expansion working states, the distance between the front and rear ends of the connecting strip 15 is variable, and the connecting strip 15 is rigid in the circumferential direction. During the process of the support frame 5 changing from the contraction working state to the expansion working state, the outer end rod 14 gradually moves away from the middle conduit 2. During the process of the support frame 5 changing from the expansion working state to the contraction working state, the outer end rod 14 gradually moves closer to the middle conduit 2. The outer end rod 14 is parallel to the middle conduit 2.

[0146] In some variant structures, see Figure 29-2 The connecting strip 15 is a rigid elastic sheet that can be bent. When the supporting frame 5 is in the contracted working state, the rigid elastic sheet is bent (not shown).

[0147] In some variant structures, see Figure 31 The connecting bar 15 includes multiple sections 17, with the ends of two adjacent sections 17 pivotally connected to form a chain. The outer conduit 3 is pivotally connected to an adjacent section 17, and the outer end rod 14 is pivotally connected to an adjacent section 17. The axis of each pivot is perpendicular to the middle conduit 2 in space.

[0148] In some variant structures (see) Figure 29-3 The connecting bar 15 includes multiple sections 17, at least two sections 17 are slidably connected by a groove, the outer end bar 14 is pivotally connected to the end of an adjacent section 17, the outer conduit 3 is pivotally connected to an adjacent section 17, and the axis of each pivot is spatially perpendicular to the middle conduit 2.

[0149] In some variant structures, see Figures 30 to 36-2 The support frame 5 includes an inner support frame 19 and multiple outer support rods 20 connected to the inner support frame 19. The outer support rods 20 are parallel to the middle guide tube 2. The multiple outer support rods 20 are distributed in a cylindrical shape with equal intervals around the inner support frame 19. The inner end 8 of the electrode film is connected to one of the outer support rods 20.

[0150] In some modified structures, the length of the electrode film 6 in the front-to-back direction is greater than or equal to the length of the outer support rod 20 in the front-to-back direction, and the length difference between the two is less than 30 mm, preferably less than 2 mm. The support frame 5 is made of elastic nickel-titanium alloy material, elastic stainless steel material, elastic plastic, etc.

[0151] See Figure 18 When the support frame 5 is in the retracted working state, the electrode film 6 is wound in multiple turns around the support frame 5; see also Figure 17 When the supporting frame 5 is in the expanded working state, the number of turns of the electrode film 6 is greater than 1 turn and less than 2 turns.

[0152] Figures 1 to 37-22 In the embodiments shown, the support frame 5 has a radially outward elastic force when it contracts, which causes the electrode film 6 to clamp the support frame 5. The innermost ring of the electrode film 6 is always in close contact with the support frame 5, and the electrode films 6 of each adjacent ring are also always in close contact with each other.

[0153] See Figures 30 to 33 The first embodiment of the support frame 5 includes an inner support frame 19 and multiple outer support rods 20. The front end of the inner support frame 19 is a front connecting ring 12, and the rear end of the inner support frame 19 is a rear connecting ring 13. Multiple outer support rods 20 parallel to the central guide tube 2 are fixedly connected to the middle section of the inner support frame 19. The multiple outer support rods 20 are distributed in a cylindrical interval (preferably at equal intervals) around the inner support frame 19. The outer support rods 20 have a front extension section 21 extending forward of the middle section of the inner support frame 19, and / or a rear extension section 22 extending backward of the middle section of the inner support frame 19, such that the length of the outer support rods 20 in the front-back direction is greater than the length of the middle section of the inner support frame 19 in the front-back direction. The inner support frame 19 is made of a nickel-titanium alloy, an elastic stainless steel, an elastic plastic, or the like.

[0154] Specifically, the inner support frame 19 includes multiple inner support rods 24. When the support frame 5 is in the expanded working state, the inner support rods 24 are in the shape of an inward-facing bow. Each outer support rod 20 is fixedly connected to the middle section of the inner support rod 24. When the support frame 5 is in the contracted working state, the inner support rods 24 are in a roughly straight shape. When the support frame 5 is in the expanded working state, the length of the outer support rods 20 in the front-back direction is greater than or equal to the length of the inner support frame 19 in the front-back direction. Furthermore, the front end of the inner support frame 19 is located behind or aligned with the front end of the outer support rods 20, and the rear end of the inner support frame 19 is located in front of or aligned with the rear end of the outer support rods 20.

[0155] Some variations of the first embodiment of the support frame 5 include: the front end of the support rod 24 and / or the rear end of the inner support rod are pivotally connected to the front connecting ring 12 or the rear connecting ring 13, respectively, with the pivot perpendicular to the inner conduit 1.

[0156] See Figure 14 Embodiment 2 of the support frame 5 includes an inner support frame 19, a middle support frame 23, and multiple outer support rods 20 parallel to the inner conduit 1 or the middle conduit 2. The front end of the inner support frame 19 is a front connecting ring 12, and the rear end of the inner support frame 19 is a rear connecting ring 13. The middle section of the middle support frame 23 is fixedly connected to the middle section of the inner support frame 19. The middle support frame 23 has a front end and a rear end. One end of the two ends is fixedly or pivotally connected to the outer support rods 20, and the other end of the two ends is slidably connected to the outer support rods 20 in the front-back direction. Multiple outer support rods 20 are distributed in a cylindrical interval (preferably at equal intervals) around the middle support frame 23. The length of the outer support rods 20 in the front-back direction is greater than or equal to the length of the middle support frame 23 in the front-back direction.

[0157] refer to Figure 24Specifically, the inner support frame 19 includes multiple inner support rods 24, and the middle support frame 23 includes multiple middle support rods 25. When the support frame is in its expanded working state, the inner support rods 24 are in an inward-facing arc shape, and the middle support rods 25 are in an outward-facing arc shape. The middle section of each middle support rod 25 is fixedly connected to the middle section of the inner support rod 24. In this embodiment, the middle section of each middle support rod 25 is fixedly connected to the middle section of the inner support rod 24 by rivets 36. When the support frame 5 is in its contracted working state, both the middle support rods 25 and the inner support rods 24 are generally straight. The middle support rod 25 has a front end 26 and a rear end 27. One end of the two ends is fixedly or pivotally connected to the outer support rod 20, and the other end of the two ends is slidably connected to the outer support rod 20 in the front-rear direction. The outer support rod 20 has a front extension section 21 extending forward of the front end 26 of the middle support rod, and / or a rear extension section 22 extending backward of the rear end 27 of the middle support rod, such that the length of the outer support rod 20 in the front-rear direction is greater than the length of the middle support rod 25 in the front-rear direction. The inner support frame 19 and the middle support frame 23 are made of nickel-titanium alloy, elastic stainless steel, elastic plastic, etc. The length of the outer support rod 20 in the front-rear direction is greater than or equal to the length of the middle support frame 23 in the front-rear direction, and the front end of the middle support frame 23 is located behind or aligned with the front end of the outer support rod 20, and the rear end of the middle support frame 23 is located in front of or aligned with the rear end of the outer support rod 20; the length of the outer support rod 20 in the front-rear direction is also greater than or equal to the length of the inner support frame 19 in the front-rear direction, and the front end of the inner support frame 19 is located behind or aligned with the front end of the outer support rod 20, and the rear end of the inner support frame 19 is located in front of or aligned with the rear end of the outer support rod 20.

[0158] In some variations of Embodiment 2 of the support frame 5, for example, the front end and / or the rear end of the inner support rod 24 are pivotally connected to the front connecting ring 12 or the rear connecting ring 13, respectively, with the pivot perpendicular to the inner conduit 1.

[0159] The distance between the front and rear ends of the support frame 5 can vary relative to each other, causing the support frame 5 to switch between contraction and expansion states. The selection of this support frame 5 requires that when the front end of the support frame 5 is farther or closer to the rear end relative to the rear end, the support frame 5 is in a contraction or expansion working state. That is, the outermost middle member of the support frame 5 is closer to or farther from the inner conduit 1, and the outermost middle member of the support frame 5 is distributed in a cylindrical interval (preferably equidistant) around the inner conduit 1. When the support frame 5 switches between the contraction and expansion working states, the shape of some individual members on the support frame 5 will change. These individual members have elastic force when compressed, and the elastic force causes the support frame 5 to tend to change from a contraction working state to an expansion working state. In the contraction working state, these elastic members are compressed by the radial contraction force of the electrode film 6. When the electrode film 6 expands, the elastic force causes the support frame 5 to enter the expansion working state. This invention only illustrates a portion of the support frame 5. The support frame referred to in this invention is not limited to the illustrated embodiments. Under the premise of meeting the above selection requirements, other unillustrated support frames based on the concept of this invention also belong to the support frames referred to in this invention.

[0160] The following combination Figures 37-1 to 37-22 Another embodiment of the support frame and the corresponding apparatus for ablation treatment of the digestive tract will be described. The main difference from the other embodiments described above lies in the specific structure of the support frame.

[0161] The support frame 5 in this embodiment also has a radially shrinking contraction working state and a radially expanding expansion working state. The support frame 5 includes multiple outer support rods 20 and an inner support frame connected to the outer support rods 20. The inner support frame includes multiple first connecting rods 52, multiple second connecting rods 53, a front connecting ring 12 located at the front, and a rear connecting ring 13 located at the rear. The multiple linkage mechanisms of the support frame include at least one X-type linkage mechanism. In the X-type linkage mechanism, the rear end 52b of the first connecting rod 52 is fixedly connected to the rear of the outer support rod 20, the front end 52a of the first connecting rod 52 is fixedly connected to the front connecting ring 12 (or integrally formed), the front end 53a of the second connecting rod 53 is fixedly connected to the front of the outer support rod 20, and the rear end 53b of the second connecting rod 53 is fixedly connected to the rear connecting ring 13 (or integrally formed). The first link 52 and the second link 53 intersect in an X shape. In some embodiments, the intersection of the first link 52 and the second link 53 is not connected, while in other embodiments, a mutually cooperating groove and pin limiting mechanism can be provided at the intersection of the first link 52 and the second link 53. This is not limited here.

[0162] In some embodiments, at least one of the front portion of the first link 52, the rear portion of the first link 52, the front portion of the second link 53, and the rear portion of the second link 53 constitutes or is provided with the deformable component. In this embodiment, all four portions of the first link 52, the rear portion of the first link 52, the front portion of the second link 53, and the rear portion of the second link 53 constitute the deformable component; the support frame has a radially decreasing contraction working state and a radially increasing expansion working state. When the support frame is in the expansion working state, the first link 52 and the second link 53 intersect and there is no rotational pivot for connection at the intersection point. The deformable component has an elastic force that causes the support frame to tend to increase radially.

[0163] This embodiment relates to an expandable component 4 for use in the system (i.e., an expandable component 4 for gastrointestinal ablation therapy, see [link]). Figures 37-12 to 37-16 (as shown) and a device for ablation therapy of the digestive tract, see [reference]. Figures 37-1 to 37-11 and Figure 37-17 As shown. The expandable component 4 is the core component for ablation therapy of the digestive tract; it can conform to the area to be treated and apply an electric field. The embodiments also relate to a system for ablation therapy of the digestive tract, comprising: Figures 37-1 to 37-11 The device shown for ablation treatment of the digestive tract also includes a signal generator configured to generate an electrical signal for generating electric field energy. The signal generator is electrically connected to a plurality of electrodes 7 disposed on an electrode membrane 6 for supplying power to it.

[0164] Reference Figures 37-1 to 37-11 The device for gastrointestinal ablation therapy includes an inner catheter 1, which is a slender rod-shaped component with a cavity for a guidewire to pass through during the procedure.

[0165] The device for gastrointestinal ablation therapy includes a middle catheter 2, which is a slender, hollow tubular component. The middle catheter 2 is sleeved on the inner catheter 1 and can rotate relative to the inner catheter 1, with the inner catheter 1 serving as its axis of rotation.

[0166] The device for gastrointestinal ablation therapy includes an outer catheter 3, which is a slender, hollow tubular component. The outer catheter 3 is fitted onto the middle catheter 2 and is rotatable relative to the middle catheter 2. The outer catheter 3 is fixed relative to the inner catheter 1, and when the middle catheter 2 rotates relative to the inner catheter 1, the middle catheter 2 also rotates within the outer catheter 3.

[0167] The system for gastrointestinal ablation therapy includes an expandable component 4. (See reference...) Figures 37-12 to 37-16 The expandable component 4 used for ablation therapy of the digestive tract has a contraction working state and an expansion working state. The expandable component 4 includes a support frame 5 and an electrode membrane 6, on which multiple electrodes 7 are disposed.

[0168] The support frame 5 includes a front connector, a rear connector, and multiple support units 51. In this embodiment, the front connector is a front connecting ring 12 with a ring structure, and the rear connector is also a rear connecting ring 13 with a ring structure. The front connector and / or the rear connector can also adopt other non-ring structures. The multiple support units 51 are each connected to a front connector and each support unit 51 is also connected to a rear connector. The front connecting ring 12 and the rear connecting ring 13 are spaced apart; the multiple support units 51 are spaced apart along the circumferential direction of the front connecting ring 12 or the rear connecting ring 13 (the circumferential direction of the inner conduit 1 or the middle conduit 2). All or part of the multiple support units 51 can deform, thereby driving the electrode film 6 to expand outward or contract inward. The number of support units 51 can be 3, 4, 5, 6, 8 or more, etc., and is not limited here.

[0169] At least one of the multiple support units 51 includes an outer support rod 20, a first connecting rod 52, and a second connecting rod 53. The front end 52a of the first connecting rod 52 is connected to the front connecting ring 12, and the rear end 52b of the first connecting rod 52 is connected to the rear end of the outer support rod 20. The front end 53a of the second connecting rod 53 is connected to the front end of the outer support rod 20, and the rear end 53b of the second connecting rod 53 is connected to the rear connecting ring 13. The first connecting rod 52, the second connecting rod 53, the front connecting ring 12, and the rear connecting ring 13 constitute the inner support frame 5. The first connecting rod 52 and the second connecting rod 53 form a cross-shaped structure (also known as an X-shaped structure), similar to scissors. The connection relationship between the first connecting rod 52 and the second connecting rod 53 is not limited. In this embodiment, the first connecting rod 52 and the second connecting rod 53 are not directly connected or connected via a pivot.

[0170] The support frame 5, which has a radially decreasing contraction working state and a radially increasing expansion working state, includes multiple outer support rods 20 and an inner support frame 5 connected to the outer support rods 20. Each outer support rod 20 and the corresponding inner support frame 5 constitute a linkage mechanism. The inner support frame 5 includes multiple first connecting rods 52, multiple second connecting rods 53, a front connecting ring 12 located at the front, and a rear connecting ring 13 located at the rear. At least one linkage mechanism is an X-type linkage mechanism. In the X-type linkage mechanism, the rear end of the first connecting rod 52 is fixedly connected to the rear of the outer support rod 20, and the front end of the first connecting rod 52 is fixedly connected to the front connecting ring 12. The front end of the second connecting rod 53 is fixedly connected to the front of the outer support rod 20, and the rear end of the second connecting rod 53 is fixedly connected to the rear connecting ring 13. In this embodiment, the support frame 5 is integrally formed, that is, the fixed connection relationship between the outer support rods 20 and the internal components of the inner support frame 5 is specifically achieved through integral forming. Furthermore, in this embodiment, all the linkage mechanisms in the entire support frame 5 are X-shaped linkage mechanisms. The rear end of the first link 52 is fixedly connected to the rear end of the outer support rod 20, and the front end of the second link 53 is fixedly connected to the front end of the outer support rod 20.

[0171] The front portion of the first link 52 is provided with or configured as a deformable component, and / or the rear portion of the first link 52 is provided with or configured as a deformable component, and / or the front portion of the second link 53 is provided with or configured as a deformable component, and / or the rear portion of the second link 53 is provided with or configured as a deformable component. That is, at least one of the four portions of the first link 52, the first link 52, the second link 53, and the second link 53 is provided with or configured as (i.e. constitutes) a deformable component. The deformable component can adopt the solutions mentioned in other embodiments of the present invention, such as processing one or more of the materials of the four components to form an elastic force at the corresponding position, or adding an external elastic element (e.g., a torsion spring) to one or more of the above positions to achieve the function of configuring a deformable component. In this embodiment, the front portion of the first link 52, the rear portion of the first link 52, the front portion of the second link 53, and the rear portion of the second link 53 all constitute deformable components. In this embodiment, by heating and shaping the support frame 5 while it is in an expanded working state, elastic deformable parts are formed at the above four positions. The corresponding elastic force causes the support frame 5 to change toward the expanded working state during heating and shaping.

[0172] When the expandable component is in the expanded working state, the first link 52 and the second link 53 intersect and there is no rotating pivot for connection at or near the intersection point.

[0173] The electrode membrane 6 is wound around multiple support units 51. The inner end of the electrode membrane 6 is connected to the support frame 5, and the outer end of the electrode membrane 6 is a free end, which can be connected to the outer conduit 3. The first connecting rod 52 and / or the second connecting rod 53 have elastic sections, which are also deformable parts. They are elastic and can return to their predetermined initial shape after the external force is removed. When the expandable component 4 is in the contracted working state, the elastic sections tend to move the outer support rod 20 outward along the diameter direction of the front connecting ring 12 or the rear connecting ring 13, so as to drive the electrode membrane 6 to expand along the diameter direction and switch to the expansion working state. The aforementioned elastic sections are made of a rigid material that has undergone shaping treatment and has a predetermined shape. Moreover, once the external force acting on the first connecting rod 52 and the second connecting rod 53 is removed and the elastic section is released, the elastic section naturally returns to its predetermined shape. For example, the elastic section can be made of metal material, which has been pre-heated and shaped to have a predetermined shape that is inclined / bent outward. Therefore, when the support frame 5 is in a released state without any external force applied, the first link 52 bends outward and tilts relative to the front connecting ring 12, and the second link 53 bends outward and tilts relative to the rear connecting ring 13, thereby pushing the outer support rod 20 outward so that the outer support rod 20 is located outside the front connecting ring 12 and the rear connecting ring 13.

[0174] The elastic segment includes at least one of the front end 52a and rear end 52b of the first link 52, and the front end 53a and rear end 53b of the second link 53. The front end 52a of the first link 52 and the front connecting ring 12 are integral, and the front end 52a of the first link 52 is elastic and has a tendency to move outward relative to the front connecting ring 12. And / or, the rear end 52b of the first link 52 and the rear end of the outer support rod 20 are integral, and the rear end 52b of the first link 52 is elastic and has a tendency to push the outer support rod 20 outward. And / or, the rear end 53b of the second link 53 and the rear connecting ring 13 are integral, and the rear end 53b of the second link 53 is elastic and has a tendency to move outward relative to the rear connecting ring 13; And / or, the front end 53a of the second link 53 and the front end of the outer support rod 20 are integral, and the front end 53a of the second link 53 is elastic and has a tendency to push the outer support rod 20 outward.

[0175] In this embodiment, all the support units 51 include the aforementioned outer support rod 20, first connecting rod 52 and second connecting rod 53. All the support units 51 work together to stretch the electrode membrane 6 outward, achieving a uniform support effect. The electrode membrane 6 and the digestive tract area to be treated have the best fit effect.

[0176] In this specific embodiment, the support frame 5 is made by cutting and shaping a tube. When the expandable component 4 is in the retracted working state, the support frame 5 is assembled into a tubular shape, as shown below. Figure 37-15 and Figure 37-16 As shown. The pipe is a metal pipe, and more specifically, it is a pipe of uniform diameter, with the diameter being the same everywhere. The metal pipe is preferably made of stainless steel, nickel alloy, titanium alloy, or nickel-titanium alloy. The material of the metal pipe is preferably a metal material with good elasticity after heat setting, capable of maintaining the predetermined shape, and thus having the elasticity to return to the initial shape after being subjected to force.

[0177] The front connecting ring 12 is formed from the front end of the pipe, specifically as a ring-shaped component. The rear connecting ring 13 is formed from the rear end of the pipe, specifically as a ring-shaped component. The rear connecting ring 13 is located behind the front connecting ring 12, and there is a gap between them, which is variable. That is, the front connecting ring 12 and the rear connecting ring 13 can move closer to each other or further away. For example, the rear connecting ring 13 can move relative to the front connecting ring 12 in the front-back direction to change the distance between them. The first connecting rod 52, the second connecting rod 53, and the outer support rod 20 are formed by cutting the main body of the pipe located between its front and rear ends along its length direction. After cutting, the first connecting rod 52, the second connecting rod 53, and the outer support rod 20 are as a whole elongated strip in the front-back direction (the length direction of the pipe). After shaping, the first connecting rod 52 and the second connecting rod 53 are in a predetermined shape that is inclined / bent outward.

[0178] The first connecting rod 52 and the second connecting rod 53 are located on opposite sides of the outer support rod 20. The front connecting ring 12, the first connecting rod 52, the outer support rod 20, the second connecting rod 53, and the rear connecting ring 13 are connected sequentially and are integral. During the above-mentioned cutting, the connection between the front connecting ring 12 and the first connecting rod 52 is not cut off, as they are integral; similarly, the connection between the first connecting rod 52 and the outer support rod 20, the connection between the outer support rod 20 and the second connecting rod 53, and the connection between the second connecting rod 53 and the rear connecting ring 13 are also not cut off. Each support unit 51 is integral, and each support unit 51, the front connecting ring 12, and the rear connecting ring 13 are also integral. The entire support frame 5 is a single integral part. The aforementioned elastic segment is formed by bending the front part 615a and the rear part 615b of the first connecting rod 52 and the front part 616a and the rear part 616b of the second connecting rod 53 outwards. Specifically, the first link 52 is shaped by heating, so that when in the retracted working state, the first link 52 tends to bend outward relative to the front connecting ring 12; the second link 53 is shaped by high temperature, so that when in the retracted working state, the second link 53 tends to bend outward relative to the rear connecting ring 13.

[0179] Furthermore, in this embodiment, the width of the front and rear parts of the outer support rod 20 is greater than the width of the front part 615a and the rear part 615b of the first connecting rod 52 connected to it and the width of the front part 616a and the rear part 616b of the second connecting rod 53 connected to it. The width of the rear part 615b of the first connecting rod 52 is less than the width of the middle part of the first connecting rod 52, and the width of the front part 615a of the first connecting rod 52 is less than the width of the middle part of the first connecting rod 52. The width of the rear portion 616b of the second connecting rod 53 is smaller than the width of the middle portion of the second connecting rod 53, and the width of the front portion 616a of the second connecting rod 53 is smaller than the width of the middle portion of the second connecting rod 53. The width of the front portion 615a and / or the rear portion 615b of the first connecting rod 52 is smaller than the width of its middle portion, so as to facilitate bending and shaping of the front portion 615a and / or the rear portion 616b of the first connecting rod 52. The width of the front portion 616a and / or the rear portion 616b of the second connecting rod 53 is smaller than the width of its middle portion, so as to facilitate bending and shaping of the front portion 616a and / or the rear portion 616b of the second connecting rod 53. The width of the rear portion of the outer support rod 20 is larger than the width of its middle portion, and the width of the front portion of the outer support rod 20 is larger than the width of its middle portion. Through holes for fixing the inner ends of the electrode film are respectively provided at both ends of the outer support rod 20 as connecting holes. Furthermore, the width of the front and / or rear portion of the outer support rod 20 is greater than the width of its middle portion. Connecting holes are provided on the front and / or rear ends of the outer support rod 20, on the front connecting ring 12, and on the rear connecting ring 13, to facilitate connection with other components.

[0180] In this embodiment, reference Figure 37-17 Both the front connecting ring 12 and the rear connecting ring 13 are connected to the middle conduit 2, and at least one of them is movably sleeved on the middle conduit 2 so as to be able to rotate relative to the middle conduit 2 and move in the front-rear direction. In this case, the inner conduit 1 can be omitted. (Refer to...) Figure 37-22 As shown. Alternatively, in some embodiments, the front connecting ring 12 is movably connected to the inner catheter 1, and the rear connecting ring 13 is connected to the middle catheter 2. Specifically, as shown... Figure 37-4 As shown, the front connecting ring 12 is movably sleeved on the inner conduit 1 and allows the inner conduit 1 to rotate relative to the front connecting ring 12, that is, the front connecting ring 12 can be slid back and forth and rotate circumferentially on the inner conduit 1; the rear connecting ring 13 is fixed to the front end of the middle conduit 2.

[0181] Specifically, the connector includes an outer end rod 14 (electrode membrane connector) and a connecting strip 15 (deformable connector) that is rigid in the circumferential direction and deformable (e.g., bending or telescoping). The outer end rod 14 is parallel to the middle guide tube 2 and connected to the outer end of the electrode membrane 6. The front end of the connecting strip 15 is connected to the rear end of the outer end rod 14, and the rear end of the connecting strip 15 is connected to the outer guide tube 3. During the transformation of the expandable component 4 from a contracted working state to an expanded working state, the outer end rod 14 gradually moves away from the middle guide tube 2. During the transformation of the support frame 5 from an expanded working state to a contracted working state, the outer end rod 14 gradually moves closer to the middle guide tube 2. The outer support rod 20 is parallel to the middle guide tube 2.

[0182] The connecting bar 15 includes multiple (e.g., two) sections 17. The front end of the adjacent subsequent section 17 is pivotally connected to the rear end of the preceding section 17 to form a chain. The front end of the foremost section 17 is pivotally connected to the rear end of the outer end bar 14. The rear end of the last section 17 is pivotally connected to the outer conduit 3. The axis of each pivot is perpendicular to the inner conduit 1 in space. When the expandable component 4 is in the contracted working state, the connecting bar 15 is bent inward or outward. When the expandable component 4 is in the expanded working state, the connecting bar 15 is generally straight.

[0183] The system for gastrointestinal ablation therapy includes an operating handle 28, with the rear (proximal) ends of the inner catheter 1 and the outer catheter 3 connected to the operating handle 28, and the middle catheter 2 connected to a rotating component (knob) provided on the operating handle 28. The rotating component can rotate relative to the operating handle 28, thereby driving the middle catheter 2 to rotate.

[0184] The method for fabricating the expandable component 4 described above includes the fabrication of the support frame 5. The support frame 5 is specifically fabricated through the following steps: S1. The pipe is cut through to form a front connecting ring, a rear connecting ring, and multiple sets of first connecting rods 52, outer support rods 20, and second connecting rods 53 disposed between the front connecting ring and the rear connecting ring. The two ends of the outer support rods 20 are adjacent to and spaced apart from the front connecting ring 12 and the rear connecting ring 13, respectively. Specifically, step S1 includes the following steps: S11. Provide a pipe; S12. Cut the pipe along its length to form multiple cutting lines 54. The multiple cutting lines 54 are spaced apart along the circumference of the pipe to form the first connecting rod 52, the outer support rod 20, and the second connecting rod 53. The starting point of each cutting line 54 is a distance from the front edge of the pipe so that the front end of the pipe forms a front connecting ring 12. The ending point of each cutting line 54 is a distance from the rear edge of the pipe so that the rear end of the pipe forms a rear connecting ring 13. S13. Cut along the circumference of the pipe to separate the rear end 52b of the first connecting rod 52 and the rear end of the outer support rod 20 from the rear connecting ring 13, and to separate the front end 53a of the second connecting rod 53 and the front end of the outer support rod 20 from the front connecting ring 12. S2. Shaping, so that the first connecting rod 52 is tilted outward relative to the front connecting ring 12, and the second connecting rod 53 is tilted outward relative to the rear connecting ring 13, to obtain the support frame 5.

[0185] In step S2, the cut pipe is heated and shaped in the expansion working state, so that the deformable parts of the shaped support frame have elastic force in the contraction working state. That is, the cut pipe is heated and shaped so that the first connecting rod 52 and the second connecting rod 53 have a predetermined shape of outward bending.

[0186] Step S3: After step S2 is performed, the support frame is converted to a retractable working state, restoring it to the shape of the cut tubular material, so that it can be installed in the device / system for digestive tract ablation therapy.

[0187] The aforementioned expandable component 4 improves the fit between the electrode 7 and the intestinal lining. Simultaneously, the front connecting ring 12, the first connecting rod 52, the outer support rod 20, the second connecting rod 53, and the rear connecting ring 13 are sequentially connected, allowing for a single, integrated design. This simplifies the manufacturing process and reduces costs. The cross-shaped structure formed by the first connecting rod 52 and the second connecting rod 53 significantly shortens the length of the support frame 5 in its contracted state compared to existing support frames 5, facilitating its transport within the digestive tract and reducing the risk of the expandable component scratching the digestive tract during transport.

[0188] The present invention also provides a system for ablation therapy of the digestive tract having the foregoing embodiments, as described above. Figure 1As shown, it includes a device for ablation therapy of the digestive tract, and further includes: a signal generator 31 configured to generate electrical signals for electric field energy. The electrical signals generated by the signal generator include electrical signals for heating target tissue, pulse signals for electric field ablation of target tissue, radiofrequency ablation signals, etc. The signal generator 31 is electrically connected to the electrodes 7 on the electrode membrane 6 via a means such as wires. The signal generator 31 generates pulse signals, and the discharge of the electrodes 7 can ablate the villi of the inner wall of the digestive tract. The signal generator 31, the method of transmitting electrical signals from the signal generator 31 to the electrodes 7, and the wiring method can all adopt existing technologies. For example, the wires between the electrodes 7 and the operating handle 28 can be arranged in the space between the outer catheter 3 and the middle catheter 2. It should be noted that information such as the material and thickness of the electrode membrane 6, the material and arrangement of the electrodes 7, the electrical connection method of the electrodes 7, and the electrical signal parameters and control methods used in ablation therapy can all be implemented using mature solutions in the prior art, and can be routinely selected and adjusted according to specific treatment needs. The above content is not the core improvement of this invention, and those skilled in the art can implement it directly based on existing technology, so it will not be elaborated further.

[0189] The present invention also provides an apparatus for ablation treatment of the human duodenum, as described in the foregoing embodiments, which is particularly suitable for treating type 2 diabetes. Specifically, the present invention also provides the use of an apparatus for ablation treatment of the human duodenum in treating type 2 diabetes. In some embodiments, a corresponding method for treating type 2 diabetes is provided, which uses the aforementioned apparatus for ablation treatment of the human duodenum. After delivering the expandable component 4 in a contracted working state to the target location, the support frame 5 is rotated relative to the outer end of the electrode membrane 6 by a rotating component (for example, in some embodiments, the central conduit 2, which serves as the rotating component, is rotated, causing the support frame 5 to rotate relative to the outer end of the electrode membrane 6; in other embodiments, the outer conduit 3, which serves as the reference component, is rotated, causing the support frame 5 to rotate relative to the outer end of the electrode membrane 6). This causes the wound electrode membrane 6 to expand radially, and the support frame 5 also expands radially under the action of a rigid elastic material (or a deformable component) until the expandable component 4 reaches the desired expansion working state; the human duodenum is then ablated / treated through the electrodes 7 on the electrode membrane 6.

[0190] In some embodiments, after treatment or processing is completed, the support frame 5 is rotated again relative to the outer end of the electrode membrane 6, so that the wound electrode membrane 6 contracts radially, and the electrode membrane 6 presses the support frame 5 to contract radially at the same time, until the contraction working state is reached; the expandable component 4 is removed from the human body from the target position.

[0191] The device for ablation treatment of the human duodenum provided by the present invention, as described in the foregoing embodiments, is particularly suitable for treating obesity. That is, the present invention also provides the use of the device for ablation treatment of the human duodenum in the treatment of obesity.

[0192] The present invention also provides the use of the aforementioned device for ablation treatment of the human duodenum in the treatment of non-alcoholic fatty liver disease.

[0193] 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 catheter assembly having a distal end and a proximal end, the catheter assembly including an elongated middle catheter and an elongated outer catheter, the outer catheter being sleeved on the middle catheter, and the middle catheter being rotatably disposed relative to the outer catheter; An expandable component, connected to the distal end of the catheter assembly, includes a flexible electrode membrane having multiple electrodes and a support component located inside the electrode membrane and used to support the electrode membrane. When the middle catheter rotates relative to the outer catheter, the expandable component can switch between a radially decreasing contraction working state and a radially increasing expansion working state. The electrode film is wound around the outside of the support member, the inner end of the electrode film is connected to the support member, and the outer end of the electrode film is connected to the outer conduit through a connector. The connector includes an outer end rod fixedly connected to the outer end of the electrode membrane and a connecting strip with rigidity in the circumferential direction. The outer end rod includes a straight section near the outer edge of the electrode membrane and parallel to the axis of the outer conduit. The rear end of the straight section is deflected toward the outer edge of the electrode membrane to form a deflection section and extends toward the rear side of the rear edge of the electrode membrane to form a connecting piece. The front end of the connecting strip is pivotally connected to the connecting piece, and the pivot is perpendicular to the axis of the outer conduit. The rear end of the connecting strip is connected to the outer conduit. During the process of the expandable component changing from a contracted working state to an expanded working state, the outer end rod gradually moves away from the outer conduit. During the process of the expandable component changing from an expanded working state to a contracted working state, the outer end rod gradually moves closer to the outer conduit.

2. A device for ablation therapy of the digestive tract, characterized in that, It includes: A catheter assembly having a distal end and a proximal end, the catheter assembly including an elongated inner catheter, an elongated middle catheter, and an elongated outer catheter, the middle catheter being sleeved on the inner catheter and rotatably disposed relative to the inner catheter; the outer catheter being sleeved on the middle catheter and rotatably disposed relative to the outer catheter; the inner catheter and the outer catheter being fixedly disposed relative to each other. An expandable component, connected to the distal end of the catheter assembly, includes a flexible electrode membrane having multiple electrodes and a support component located inside the electrode membrane and used to support the electrode membrane. When the middle catheter rotates relative to the outer catheter, the expandable component can switch between a radially decreasing contraction working state and a radially increasing expansion working state. The electrode membrane is wound around the outside of the support member, the inner end of the electrode membrane is connected to the support member, and the outer end of the electrode membrane is connected to the inner conduit via a connector. The connector includes an outer end rod fixedly connected to the outer end of the electrode membrane and a connecting strip with rigidity in the circumferential direction. The outer end rod includes a straight section near the outer edge of the electrode membrane and parallel to the axis of the outer conduit. The front end of the straight section is deflected toward the outer edge of the electrode membrane to form a deflection section and extends toward the front side of the front edge of the electrode membrane to form a connecting piece. The rear end of the connecting strip is pivotally connected to the connecting piece, and the pivot is perpendicular to the axis of the outer conduit. The front end of the connecting strip is connected to the inner conduit. During the process of the expandable component changing from a contracted working state to an expanded working state, the outer end rod gradually moves away from the inner conduit. During the process of the expandable component changing from an expanded working state to a contracted working state, the outer end rod gradually moves closer to the inner conduit.

3. The apparatus for ablation therapy of the digestive tract according to claim 1 or 2, characterized in that, The center line of the straight section is substantially parallel to the center line of the connecting piece.

4. The apparatus for ablation therapy of the digestive tract according to claim 3, characterized in that, The distance between the centerline of the straight section and the centerline of the connecting piece is 0.5-2mm; and / or, the width of the straight section or the connecting piece is 0.5-4mm.

5. The apparatus for ablation therapy of the digestive tract according to claim 1 or 2, characterized in that, The connecting piece is substantially tangent to the electrode film.

6. The apparatus for ablation therapy of the digestive tract according to claim 1 or 2, characterized in that, The deflection part is arc-shaped or S-shaped.

7. The apparatus for ablation therapy of the digestive tract according to claim 1 or 2, characterized in that, The pivot is composed of the connecting piece, the connecting strip, and the rotating shaft. The rotating shaft includes a shaft body and a support portion extending from the shaft body toward the electrode film. The support portion includes a bottom wall and two side walls. The bottom wall of the support portion supports at least a portion of the inner wall of the connecting piece. The two side walls of the support portion abut against the two side walls of the connecting piece, respectively.

8. The apparatus for ablation therapy of the digestive tract according to claim 7, characterized in that, The connecting piece is fixedly connected to the supporting part; And / or, the outer end rod is made of a rigid material.

9. The apparatus for ablation therapy of the digestive tract according to claim 7, characterized in that, The supporting part is integrally formed with the shaft body, or the supporting part is fixedly connected to the shaft body.

10. The apparatus for ablation therapy of the digestive tract according to claim 1 or 2, characterized in that, The electrode film includes an inner surface and an outer surface. The outer surface includes a first region and a second region. The plurality of electrodes are arranged in parallel and spaced apart in the first region. The device also includes a polymer film layer disposed outside the second region and inside the inner surface of the electrode film. The thickness of the polymer film layer is less than 100 μm.

11. The apparatus for ablation therapy of the digestive tract according to claim 1 or 2, characterized in that, The straight sections are all located on the electrode film.

12. The apparatus for ablation therapy of the digestive tract according to claim 1 or 2, characterized in that, The deflection portion is entirely located on the electrode film.

13. The apparatus for ablation therapy of the digestive tract according to claim 1 or 2, characterized in that, The electrode comprises a copper substrate layer and an inert metal layer, wherein the inert metal layer is selected from one or a combination of platinum, iridium, gold, and silver; And / or, the thickness of the electrode film is 0.1-0.5 mm.

14. The apparatus for ablation therapy of the digestive tract according to claim 1 or 2, characterized in that, When the support component changes between the contracted working state and the expanded working state, the distance between the front and rear ends of the connecting strip can be variably set.

15. The apparatus for ablation therapy of the digestive tract according to claim 1 or 2, characterized in that, The rear end of the support component is connected to the central conduit, and the electrode film is wound around the support component.

16. The apparatus for ablation therapy of the digestive tract according to claim 1 or 2, characterized in that, The support member has a deformable component, and when the support member changes between a contracted working state and an expanded working state, the deformable component changes shape. The deformable component is made of a rigid elastic material, and the deformable component gives the support member a radially outward elastic force that changes from a contracted working state to an expanded working state.

17. The apparatus for ablation therapy of the digestive tract according to claim 1 or 2, characterized in that, The supporting component is a balloon.

18. The apparatus for ablation therapy of the digestive tract according to claim 1 or 2, characterized in that, It also includes an operating handle connected to the proximal end of the catheter assembly, the operating handle being used to actuate the middle catheter, causing the middle catheter to rotate relative to the outer catheter.

19. A system for ablation therapy of the digestive tract, characterized in that, It includes a signal generator and an apparatus for ablation treatment of the digestive tract as described in any one of claims 1-2, wherein the signal generator is configured to generate an electrical signal of electric field energy and is electrically connected to the electrodes.

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