Devices, systems, and uses for ablation treatment of the digestive tract

Abstract

The present invention relates to a device for ablation therapy of the digestive tract, comprising an inner guide rod, an outer sleeve, an expandable member comprising a support skeleton and an electrode array film, said support skeleton having a radially reduced collapsed working state and a radially enlarged expanded working state, said support skeleton comprising a plurality of linkages which allow said support skeleton to transform between the collapsed working state and the expanded working state, said support member supporting the electrode array film when in the radially enlarged expanded working state, allowing accurate treatment of the inner wall of the upper digestive tract, in particular the duodenum.

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] In the prior art, CN114786605A discloses a device for duodenal pulsed electric field therapy. This device adapts to the shape of the duodenal wall using an expandable member wound around a second elongated body. This expandable member is generally made of a flexible polymer membrane with electrodes disposed on it. However, this membrane has poor rigidity after expansion and is easily deformed by pressure from the intestinal wall, resulting in poor circumferential adhesion to the intestinal wall. When an electric field is applied to the intestinal tissue, it is difficult to accurately ablate the approximately 1 mm villous tissue of the intestine. Summary of the Invention

[0003] The purpose of this invention is to provide an apparatus, system, and application for ablation therapy of the digestive tract, wherein the apparatus has better rigidity after expansion.

[0004] The technical solution of the present invention is: a device for ablation therapy of the digestive tract, comprising:

[0005] The inner guide rod includes a front inner guide rod and a rear inner guide rod. The rear end of the front inner guide rod is connected to the front end of the rear inner guide rod. The front inner guide rod is a rigid rod, and the rear inner guide rod is a non-rigid member that is easy to bend. When the rear part of the rear inner guide rod rotates, the front part of the front inner guide rod also rotates synchronously.

[0006] The outer tube is a flexible, non-rigid component, and when the rear of the outer tube rotates, the front of the outer tube also rotates synchronously; the outer tube is fitted onto the rear inner guide rod, and the inner guide rod is rotatably arranged relative to the outer tube.

[0007] An expandable component surrounds the inner front guide rod and is located outside the inner front guide rod, wherein the expandable component includes:

[0008] A support frame has a radially contracting working state and a radially expanding working state. The support frame includes multiple linkage mechanisms, at least one of which is an X-type linkage mechanism. The X-type linkage mechanism includes a first link, a second link, and a side link. The first and second links intersect, and the outer ends of the first and second links are respectively connected to the side link. The inner end of the first link is connected to a rear connecting seat, and the inner end of the second link is connected to a front connecting seat. The front connecting seat is sleeved on the front part of the inner guide rod and the two are rotatably connected by a thread. The rear connecting seat is fixedly connected to the front end of the outer sleeve. During the forward or reverse rotation of the inner guide rod relative to the outer sleeve, the distance between the rear and front connecting seats changes, and the distance between the outer ends of the first and second links also changes accordingly. Therefore, the support frame changes between the contracting and expanding working states.

[0009] An electrode array membrane includes multiple electrodes for receiving electrical signals. The electrode array membrane is connected to a support frame. When the support frame is in an expanded working state, the electrode array membrane is stretched open. When the support frame is in a contracted working state, the electrode array membrane contracts onto the support frame.

[0010] Preferably, a rear locking block is fixed on the front inner guide rod. The rear locking block is used to prevent the rear connecting seat from moving forward or backward axially relative to the front inner guide rod, but allows the front inner guide rod to rotate relative to the rear connecting seat. The rear locking block is engaged with the rear connecting seat or the front end of the outer sleeve.

[0011] Preferably, a rear locking block is fixed to the front part of the rear connecting seat or the outer sleeve. The rear locking block is used to prevent the rear connecting seat from moving forward or backward axially relative to the front inner guide rod, but allows the front inner guide rod to rotate relative to the rear connecting seat. The rear locking block is engaged with the front inner guide rod.

[0012] Preferably, the front end of the front inner guide rod is connected to a front guide cap, and the front end of the outer sleeve is connected to a rear guide cap. When the support frame is in a retracted working state, the front guide cap and the rear guide cap respectively cover the front and rear ends of the support frame. The front guide cap and the rear guide cap have generally conical outer surfaces. The outer diameter of the conical outer surface of the front guide cap gradually decreases from back to front, while the outer diameter of the conical outer surface of the rear guide cap gradually decreases from front to back. The front inner guide rod and the rear inner guide rod are connected inside the rear guide cap.

[0013] Preferably, the inner guide rod or outer sleeve of the rear section is formed by spirally winding a metal strip into a spring shape.

[0014] Preferably, the outer tube or the rear inner guide rod is a hollow tubular component. The outer tube or the rear inner guide rod has a plurality of hollowed-out and parallel strip openings spaced apart on its body. The plurality of strip openings are arranged along the axial direction of the outer tube or the rear inner guide rod, and the strip openings are not parallel to the axis of the outer tube or the rear inner guide rod.

[0015] Preferably, the strip openings are arranged in at least two rows along the axial direction of the outer sleeve or the rear inner guide rod, and adjacent two strip openings in adjacent rows are staggered in the circumferential direction.

[0016] Preferably, the outer sleeve is further wrapped with an outer sheath, and a wire for transmitting electrical signals to the electrodes on the electrode array film is provided between the outer sleeve and the outer sheath.

[0017] Another technical solution is a device for ablation therapy of the digestive tract, comprising:

[0018] The inner guide rod includes a front inner guide rod and a rear inner guide rod. The rear end of the front inner guide rod is connected to the front end of the rear inner guide rod. The front inner guide rod is a rigid member, and the rear inner guide rod is a non-rigid member that is easily bent. When the rear part of the rear inner guide rod rotates, the front part of the front inner guide rod also rotates synchronously.

[0019] The outer sleeve includes a front outer sleeve and a rear outer sleeve. The rear end of the front outer sleeve is connected to the front end of the rear outer sleeve. The front outer sleeve is a rigid rod, and the rear outer sleeve is a flexible, non-rigid member. When the rear of the rear outer sleeve rotates, the front of the front outer sleeve also rotates synchronously. The front outer sleeve is fitted onto the front inner guide rod, and the rear outer sleeve is fitted onto the rear inner guide rod. The outer sleeve is rotatably configured relative to the inner guide rod.

[0020] An expandable component surrounds the front outer sleeve and / or the front inner guide rod and is located outside the front outer sleeve and / or the front inner guide rod, wherein the expandable component comprises:

[0021] A support frame has a radially contracted working state and a radially expanded working state. The support frame includes multiple linkage mechanisms, at least one of which is an X-type linkage mechanism. The X-type linkage mechanism includes a first link, a second link, and a side link. The first and second links intersect, with the outer ends of the first and second links respectively connected to the side link. The inner end of the first link is connected to a rear connecting seat, and the inner end of the second link is connected to a front connecting seat. The front connecting seat is fixedly connected to the front inner guide rod, and the rear connecting seat is sleeved on the front outer sleeve, with the two being threaded and rotatably connected. During the forward or reverse rotation of the front outer sleeve relative to the front inner guide rod, the distance between the rear and front connecting seats changes, as does the distance between the outer ends of the first and second links, thus causing the support frame to switch between the contracted and expanded working states.

[0022] An electrode array membrane includes multiple electrodes for receiving electrical signals. The electrode array membrane is connected to a support frame. When the support frame is in an expanded working state, the electrode array membrane is stretched open. When the support frame is in a contracted working state, the electrode array membrane contracts onto the support frame.

[0023] Preferably, a front locking block is fixed on the front outer tube. The front locking block is used to prevent the front outer tube from moving forward or backward axially relative to the front connecting seat, but allows the front outer tube to rotate relative to the front connecting seat. The front locking block is engaged with the front connecting seat or the front inner guide rod.

[0024] Preferably, a front locking block is fixed on the front connecting seat or the front inner guide rod. The front locking block is used to prevent the front outer tube from moving forward or backward axially relative to the front connecting seat, but allows the front outer tube to rotate relative to the front connecting seat. The front locking block is engaged with the front outer tube.

[0025] Preferably, the front end of the front inner guide rod is connected to a front guide cap, and the front end of the rear outer tube is connected to a rear guide cap. When the support frame is in a retracted working state, the front guide cap and the rear guide cap respectively cover the front and rear ends of the support frame. The front and rear guide caps have generally conical outer surfaces. The outer diameter of the conical outer surface of the front guide cap gradually decreases from back to front, while the outer diameter of the conical outer surface of the rear guide cap gradually decreases from front to back. The front inner guide rod and the rear inner guide rod are connected inside the rear guide cap, and the front outer tube and the rear outer tube are also connected inside the rear guide cap.

[0026] Preferably, the rear inner guide rod or the rear outer sleeve is formed by spirally winding a metal strip into a spring shape.

[0027] Preferably, the rear outer tube or the rear inner guide rod is a hollow tubular component. The tube body of the rear outer tube or the rear inner guide rod has a plurality of hollow and parallel strip openings spaced apart. The plurality of strip openings are arranged along the axial direction of the rear outer tube or the rear inner guide rod, and the strip openings are not parallel to the axis of the rear outer tube or the rear inner guide rod.

[0028] Preferably, the strip openings are arranged in at least two rows along the axial direction of the rear outer sleeve or the rear inner guide rod, and adjacent two strip openings in adjacent rows are staggered in the circumferential direction.

[0029] Preferably, the outer side of the rear outer tube is further wrapped with an outer sheath, and a wire for transmitting electrical signals to the electrodes on the electrode array film is provided between the rear outer tube and the outer sheath.

[0030] Preferably, the inner guide rod has an axial guide wire through hole in the center, and an insulating layer is fixedly attached to the inner wall of the guide wire through hole.

[0031] Preferably, the first link and the second link are rotatably connected by a pivot at their intersection.

[0032] Preferably, each linkage mechanism is an X-type linkage mechanism, and the number of linkage mechanisms is 4-10.

[0033] Preferably, one of the outer ends of the first connecting rod and the second connecting rod is slidably connected to the side rod, and the other outer end is rotatably connected to the side rod via a pivot.

[0034] Preferably, the side rod has a guide groove extending in the front-rear direction of the side rod, and one of the outer ends of the first connecting rod and the second connecting rod is slidably connected to the side rod through the guide groove.

[0035] Preferably, the outer ends of the first connecting rod and the second connecting rod are slidably connected to the front and rear parts of the side rod, respectively.

[0036] Preferably, the front and rear portions of the side rod are respectively provided with a first arc-shaped guide groove and a second arc-shaped guide groove. The outer ends of the first connecting rod and the second connecting rod are slidably connected to the front and rear portions of the side rod through the first arc-shaped guide groove and the second arc-shaped guide groove, respectively. The first arc-shaped guide groove bends from back to front inward, and the second arc-shaped guide groove bends from back to front inward.

[0037] Preferably, the side rod is a telescopic rod formed by connecting at least two rods to create a variable length in the front-to-back direction, and the outer ends of the first connecting rod and the second connecting rod are rotatably connected to the front and rear ends of the telescopic rod via pivots, respectively.

[0038] Preferably, the inner end of the first connecting rod is rotatably connected to the rear connecting seat via a pivot, and the inner end of the second connecting rod is rotatably connected to the front connecting seat via a pivot.

[0039] Preferably, the inner end of the first link is fixedly connected to the rear connecting seat, or / and the inner end of the second link is fixedly connected to the front connecting seat. When the support frame changes between the contracted working state and the expanded working state, the inner end of the first link or / and the inner end of the second link are allowed to deform and bend.

[0040] Preferably, it further includes an operating handle connected to the rear of the inner guide rod and / or the rear of the outer tube, the operating handle being provided with an adjustment device for adjusting the relative rotation of the outer tube and the inner guide rod, or for adjusting the relative rotation of the inner guide rod relative to the outer tube.

[0041] Preferably, when the support frame is in a contracted working state and / or an expanded working state, the side rods on each linkage mechanism are parallel to the front of the inner guide rod, and the side rods are arranged circumferentially around the axis of the inner guide rod.

[0042] Preferably, when the support frame is in a retracted working state, the electrode array film is wound or / and folded onto the support frame.

[0043] Preferably, the electrode array membrane is shaped like a spiral spring, possessing radially self-contracting elastic force. The electrode array membrane is wound around each of the side rods, with its inner end connected to one of the side rods and its outer end being a free end. During the transition of the support frame from a contracted working state to an expanded working state, each side rod expands the electrode array membrane outward, causing the diameter of the outermost layer of the electrode array membrane on each side rod to gradually increase, and the total number of turns of the electrode array membrane to gradually decrease. During the transition of the support frame from an expanded working state to a contracted working state, the self-contracting elastic force of the electrode array membrane causes the diameter of the outermost layer of the electrode array membrane to gradually decrease, and the total number of turns of the electrode array membrane to gradually increase.

[0044] Preferably, the electrode array film is provided with shape memory alloy strips, and when the support frame is in a contracted working state, the shape of the electrode array film is the memory shape of the shape memory alloy strips.

[0045] Preferably, the length of the side rod in the front-back direction is approximately equal to the width of the electrode array film in the front-back direction, with a difference of less than 1.5 mm, and preferably less than 0.5 mm or equal.

[0046] A system for ablation therapy of the digestive tract, comprising the aforementioned apparatus for ablation therapy of the digestive tract, further comprising:

[0047] A signal generator configured to generate an electrical signal for treatment and electrically connected to electrodes.

[0048] An apparatus for duodenal ablation therapy, comprising the aforementioned apparatus for ablation therapy of the digestive tract.

[0049] The above-mentioned device for duodenal ablation therapy is used in the treatment of diabetes.

[0050] The above-mentioned device for duodenal ablation therapy is used in the treatment of obesity. Attached Figure Description

[0051] Appendix Figure 1 This is a front view of the device with an operating handle, in which the support frame is in a retracted working state;

[0052] Appendix Figure 2 This is a perspective view of the device without an operating handle, in which the support frame is in an expanded working state;

[0053] Appendix Figure 3The partial cross-sectional view of the operating handle located at the proximal end shows the structure of an adjustment device in which the inner guide rod can be driven to move in the front-back direction relative to the outer sleeve without rotating by rotating the first knob.

[0054] Appendix Figure 4 This is a perspective view of one embodiment of the support frame, in which the support frame is in an expanded working state;

[0055] Appendix Figure 5 for Figure 4 The main view of the support frame is drawn when only one linkage mechanism is shown. At this time, the support frame is in the expanded working state.

[0056] Appendix Figure 6 for Figure 4 The front view of this linkage mechanism shows the support frame in a retracted working state.

[0057] Appendix Figure 7 This is a perspective view of another embodiment of the support frame, in which the support frame is in an expanded working state;

[0058] Appendix Figure 8 for Figure 7 The front view of the supporting frame, at which point the supporting frame is in the retracted working state;

[0059] Appendix Figure 9 The third embodiment of the support frame is shown in the main view of only one linkage mechanism, in which the support frame is in an expanded working state.

[0060] Appendix Figure 10 for Figure 9 The front view of the supporting frame when it is in the retracted working state;

[0061] Appendix Figure 11 The fourth embodiment of the support frame is shown with only one main view of the linkage mechanism, in which the support frame is in an expanded working state.

[0062] Appendix Figure 12 for Figure 11 The front view of the supporting frame when it is in the retracted working state;

[0063] Appendix Figure 13 for Figure 2 The top view of an embodiment in which the electrode array film is wound and folded onto the support frame when the support frame is in the retracted working state;

[0064] Appendix Figure 14 for Figure 2 The top view of another embodiment in which the electrode array film is folded between the support frame supports when the support frame is in the retracted working state;

[0065] Appendix Figure 15 for Figure 2 The top view of the third embodiment, in which the electrode array film is wound around the support frame when the support frame is in the retracted working state;

[0066] Appendix Figure 16 for Figure 15 A top view of the electrode array film wrapped around the support frame when the support frame is in the expanded working state.

[0067] Appendix Figure 17 To support the frame, only two main sectional views of the linkage mechanism are drawn. This is an example of the connection structure between the front connecting seat and the rear connecting seat and the inner guide rod or outer sleeve. At this time, the support frame is in a fully expanded working state.

[0068] Appendix Figure 18 for Figure 17 The main sectional view of the supporting skeleton in an incompletely expanded working state;

[0069] Appendix Figure 19 To support the frame, only two main sectional views of the linkage mechanism are drawn. This is an example of the connection structure between the front connecting seat and the rear connecting seat and the inner guide rod or outer sleeve. At this time, the support frame is in a fully expanded working state.

[0070] Appendix Figure 20 for Figure 19 The main sectional view of the supporting skeleton in an incompletely expanded working state;

[0071] Appendix Figure 21 To support the frame, only two main sectional views of the linkage mechanism are drawn. This is an example of the connection structure between the front connecting seat and the rear connecting seat and the inner guide rod or outer sleeve. At this time, the support frame is in a fully expanded working state.

[0072] Appendix Figure 22 for Figure 21 The main sectional view of the supporting skeleton in an incompletely expanded working state;

[0073] Appendix Figure 23 To support the frame, only two main sectional views of the linkage mechanism are drawn. This is an example of the connection structure between the front connecting seat and the rear connecting seat and the inner guide rod or outer sleeve. At this time, the support frame is in a fully expanded working state.

[0074] Appendix Figure 24 for Figure 23 The main sectional view of the supporting skeleton in an incompletely expanded working state;

[0075] Appendix Figure 25The front view of the operating handle located at the proximal end shows the structure of another adjustment device. By rotating the second knob, the outer sleeve can be driven to move in the back-and-forth direction relative to the inner guide rod without rotating.

[0076] Appendix Figure 26 for Figure 25 BB direction sectional view;

[0077] Appendix Figure 27 for Figure 25 A sectional view along the AA direction;

[0078] Appendix Figure 28 The cross-sectional view of the operating handle located at the proximal end shows the structure of the third type of adjustment device. By rotating the third knob, the inner guide rod can be driven to move and rotate in a spiral back-and-forth direction relative to the outer tube.

[0079] Appendix Figure 29 The cross-sectional view of the operating handle located at the proximal end shows the structure of the fourth type of adjustment device. By rotating the fourth knob, the inner guide rod can be driven to rotate relative to the outer tube but not move in the back-and-forth direction.

[0080] Appendix Figure 30 This is a front view of the support frame of the present invention in its expanded working state when the inner guide rod is used as the rotation drive rod;

[0081] Appendix Figure 31 For the appendix Figure 30 EE direction sectional view;

[0082] Appendix Figure 32 This is a front view of the support frame of the present invention in its retracted working state when the inner guide rod is used as the rotation drive rod;

[0083] Appendix Figure 33 For the appendix Figure 32 A cross-sectional view in the FF direction;

[0084] Appendix Figure 34 For the appendix Figure 33 Enlarged cross-sectional view in the GG direction;

[0085] Appendix Figure 35 This is a front view of the support frame of the present invention in its expanded working state when the outer sleeve is used as the rotation drive rod;

[0086] Appendix Figure 36 For the appendix Figure 35 HH direction cross-sectional view;

[0087] Appendix Figure 37 This is a front view of the support frame of the present invention in its retracted working state when the outer sleeve is used as the rotation drive rod;

[0088] Appendix Figure 38 For the appendix Figure 37 Sectional view in direction II;

[0089] Appendix Figure 39 For the appendix Figure 38 A magnified cross-sectional view in the JJ direction;

[0090] Appendix Figure 40 The cross-sectional view of the operating handle located at the proximal end shows the structure of the fifth type of adjustment device. By rotating the fifth knob, the outer sleeve can be driven to rotate relative to the inner guide rod but not move in the back-and-forth direction.

[0091] Appendix Figure 41 This is the front view of the outer sleeve; the front section of the outer sleeve is a rigid member, the rear section of the outer sleeve is a non-rigid member that is easy to bend, and the last section of the rear outer sleeve near the proximal end is a rigid member.

[0092] Appendix Figure 42 For the appendix Figure 41 A cross-sectional view along the CC direction;

[0093] Appendix Figure 43 This is the front view of the inner guide rod; the front section of the inner guide rod is a rigid member, the rear section of the inner guide rod is a non-rigid member that is easy to bend, and the last section of the inner guide rod near the proximal end is a rigid member.

[0094] Appendix Figure 44 For the appendix Figure 43 DD-direction sectional view;

[0095] The components include: 1. Inner guide rod; 2. Outer sleeve; 3. Expandable component; 4. Support frame; 5. Linkage mechanism; 6. X-type linkage mechanism; 7. First link; 8. Second link; 9. Side rod; 10. Outer end of the first link; 11. Outer end of the second link; 12. Inner end of the first link; 13. Rear connector; 14. Inner end of the second link; 15. Front connector; 16. Electrode array film; 17. Electrode; 18. Guide groove; 19. First arc-shaped guide groove; 20. Second arc-shaped guide groove; 21. First thread; 22. Second thread; 23. Slider; 24. Stress dissipation tube; 25. First side guide rod; 26. 27. Second side guide rod; 28. Operating handle; 29. ​​Adjustment device; 30. Inner end of electrode array membrane; 31. Outer end of electrode array membrane; 32. First knob; 33. Front guide cap; 34. Rear guide cap; 35. Gear; 36. Rack; 37. Knob pivot; 38. Second knob; 39. Third knob; 40. Fourth knob; 41. Slider guide; 42. Front inner guide rod; 43. Rear inner guide rod; 44. Rear locking block; 45. Strip opening; 46. Insulating layer; 47. Outer sheath; 48. Front locking block; 49. Guide wire through hole; 50. Front outer sleeve; 51. Rear outer sleeve; 52. Fifth knob; Detailed Implementation

[0096] 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 a gastroscopy can be inserted, including the esophagus, stomach, and duodenum. This invention is particularly applicable to the upper digestive tract. "Front" in this invention refers to the direction in which the device advances into the digestive tract, and "rear" refers to the direction of retraction, for example, as shown in the attached image. Figure 1 In this context, the left-facing direction is considered the front, and the right-facing direction is considered the rear. The terms "front" and "rear" in this article are defined in the same direction. The front end also refers to the end furthest from the operator (doctor), and is also known in the industry as the distal end; the rear end refers to the end closest to the operator, and is also known in the industry as the proximal end.

[0097] Referring to the accompanying drawings, an apparatus for ablation therapy of the digestive tract includes:

[0098] Inner guide rod 1;

[0099] Outer tube 2, which is sleeved on the inner guide rod 1;

[0100] Expandable component 3 surrounds the inner guide rod 1 and / or the outer sleeve 2 and is located near the front of the inner guide rod 1, wherein the expandable component 3 includes:

[0101] Support frame 4, wherein the support frame 4 has a radially shrinking contraction working state (e.g. Figure 1 ) and radially increasing expansion working state (such as Figure 2 (See appendix) Figure 4 To be continued Figure 12 The supporting frame 4 includes multiple linkage mechanisms 5, wherein there are 4-10 linkage mechanisms, preferably 5-8, and particularly preferably 6-7. At least one linkage mechanism is an X-type linkage mechanism 6, which includes a first link 7, a second link 8, and a side link 9. The first link 7 and the second link 8 intersect. The outer ends 10 and 11 of the first link and the second link are respectively connected to the side link 9. The inner end of the first link is connected to the rear connecting seat 13, and the inner end 14 of the second link is connected to the front connecting seat 15. The front connecting seat 15 is connected to the inner guide rod 1 and / or the outer sleeve 2. The rear connecting seat 13 is connected to the inner guide rod 1 and / or the outer sleeve 2. The outer sleeve 2 is rotatably connected to the inner guide rod 1, or is movable only in the front-back direction, or is both movable in the front-back direction and rotatably connected. The above connection method is used to drive the distance between the rear connecting seat 13 and the front connecting seat 15 to change, and thus the distance between the outer ends 10 and 11 of the first link and the second link also changes accordingly. Therefore, the support frame 4 changes between a contracted working state and an expanded working state.

[0102] An electrode array film 16 includes a plurality of electrodes 17 for receiving electrical signals, and the electrode array film 16 is connected to the support frame 4. See appendix. Figure 2 When the supporting frame 4 is in its expanded working state, the electrode array film 16 is stretched open. (See attached diagram) Figure 13 Appendix Figure 14 Appendix Figure 15 When the support frame 4 is in the retracted working state, the electrode array film 16 retracts onto the support frame 4. The support frame 4, inner guide rod 1, and outer tube 2 are made of stainless steel.

[0103] See appendix Figure 3 To be continued Figure 12 The first link 7 and the second link 8 are rotatably connected by a pivot at their intersection. This ensures stable movement of the links within the support frame 4 as it transitions between a contracted and expanded working state. In the embodiments provided by this invention, each linkage mechanism is the same X-type linkage mechanism 6. However, some linkage mechanisms may use non-X-type linkage mechanisms 6.

[0104] See appendix Figure 7 and attached Figure 8 and attached Figure 9 and attached Figure 10 One of the outer ends of the first connecting rod 10 and the second connecting rod 11 is slidably connected to the side rod 9, and the other outer end is rotatably connected to the side rod 9 via a pivot. The sliding connection is achieved by providing a guide groove 18 extending along the front-rear direction of the side rod 9, through which one of the outer ends of the first connecting rod 10 and the second connecting rod 11 is slidably connected to the side rod 9.

[0105] See appendix Figure 11 and attached Figure 12 The outer ends 10 and 11 of the first connecting rod are slidably connected to the front and rear parts of the side rod 9, respectively. One sliding connection structure has a first arc-shaped guide groove 19 and a second arc-shaped guide groove 20 respectively provided on the front and rear parts of the side rod 9. The outer ends 10 and 11 of the first connecting rod are slidably connected to the front and rear parts of the side rod 9 through the first arc-shaped guide groove 19 and the second arc-shaped guide groove 20, respectively. (See attached diagram) Figure 11As shown, the first arc-shaped guide groove 19 bends inward from back to front, and the second arc-shaped guide groove 20 bends outward from back to front. The aforementioned first arc-shaped guide groove 19 and second arc-shaped guide groove 20 can make the movement of each rod in the support frame 4 smooth and the movement trajectory relatively simple.

[0106] See appendix Figure 4 To be continued Figure 6 The side rod 9 is a telescopic rod formed by connecting at least two rods to create a variable length in the front-to-back direction. Figure 4 To be continued Figure 6 Two rods are selected to form a telescopic rod, which is similar to the structure of a telescopic antenna, that is, one rod is inserted into the other rod and slidably connected to adjust its length. The two outer ends of the first connecting rod 7 and the second connecting rod 8 are rotatably connected to the front end and the rear end of the telescopic rod, respectively, via pivots.

[0107] See appendix Figure 2 Appendix Figure 4 To be continued Figure 12 and attached Figure 17 To be continued Figure 24 The inner end 12 of the first connecting rod is rotatably connected to the rear connecting seat 13 via a pivot, and the inner end 14 of the second connecting rod is rotatably connected to the front connecting seat 15 via a pivot. As an alternative structure for the pivotally rotatable connection described above (not shown), the inner end 12 of the first connecting rod is fixedly connected to the rear connecting seat 13, and / or the inner end 14 of the second connecting rod is fixedly connected to the front connecting seat 15. This fixed connection is appropriately weaker relative to the two connecting rods to facilitate bending under stress. When the support frame changes between a contracted working state and an expanded working state, the inner end 12 of the first connecting rod and / or the inner end 14 of the second connecting rod are allowed to deform and bend. This structure is relatively simple and can reduce manufacturing costs; however, a greater driving force is required to control the transformation of the support frame from the contracted working state to the expanded working state.

[0108] See appendix Figure 1 Appendix Figure 3 Appendix Figure 25 To be continued Figure 29 The device also includes an operating handle 27, on which an adjusting device 28 is provided or connected. The adjusting device 28 is used to adjust the relative position of the outer sleeve 2 and the inner guide rod 1, so that the outer sleeve 2 can move and / or rotate relative to the inner guide rod 1 in the front-back direction, or that the inner guide rod 1 can move and / or rotate relative to the outer sleeve 2 in the front-back direction. That is, the adjusting device 28 controls the relative movement of the inner guide rod 1 and the outer sleeve 2.

[0109] See appendix Figure 25 To be continued Figure 27 A second knob 37 is rotatably connected to the middle of the operating handle 27, but cannot move forward or backward (limited by the operating handle 27). A slider 23, movable relative to the operating handle 27 in the forward / backward direction, is disposed within the inner cavity of the second knob 37. The slider 23 is slidably connected to a slider guide rod 40 extending in the forward / backward direction and fixed to the operating handle 27. An outer sleeve 2 is fixedly connected to the slider 23. The outer surface of the slider 23 is also threaded, and the inner surface of the second knob 37 is also threaded to mate with the thread of the slider 23, with the two threads meshing. The rear end of the inner guide rod 1 is fixedly connected to the rear end of the operating handle 27. A stress-dissipating tube 24, fitted onto the outer guide tube 2, is connected to the front end of the operating handle 27 to prevent the outer sleeve 2 and the inner guide rod 1 from breaking under stress at the connection point with the front end of the operating handle 27. When the operating handle 27 is held and the second knob 37 is rotated in both directions, the second knob 37 drives the slider 23 to move forward and backward without rotating, thereby causing the outer tube 2 fixed on the slider 23 to move only forward and backward relative to the inner guide rod 1 without rotating. When this device is inserted into the human digestive tract, with the inner wall of the digestive tract as a reference, the support frame 4 does not rotate. The adjusting device 28 controls the outer tube 2 to move forward and backward relative to the inner guide rod 1 without rotating, thereby driving the support frame 4 to switch between the contraction and expansion working states. When it is necessary for the support frame 4 to rotate, the operating handle 27 can be rotated.

[0110] Refer to the above appendix Figure 25 To be continued Figure 26 Another similar adjustment device 28 (not shown) can be designed to function in conjunction with the attached... Figure 3 The same function is achieved by adjusting the inner guide rod 1 relative to the outer tube 2, moving it forward and backward without rotating it. A second knob 37 is rotatably connected to the rear of the operating handle 27, but not forward and backward (limited by the operating handle 27). A slider 23, movable relative to the operating handle 27 in the forward and backward direction, is disposed within the inner cavity of the second knob 37. The slider 23 is slidably connected to a slider guide rod 40 extending forward and backward and fixed to the operating handle 27. The rear of the inner guide rod 1 is fixedly connected to the slider 23. The outer surface of the slider 23 is also threaded, and the inner surface of the second knob 37 is also threaded to mate with the thread of the slider 23, with the two threads meshing. The rear end of the outer tube 2 is fixedly connected to the front of the operating handle 27. When the operating handle 27 is held and the second knob 37 is rotated in both directions, the second knob 37 drives the slider 23 to move in the front-back direction but not rotate through the thread, thereby causing the inner guide rod 1 fixed on the slider 23 to move only in the front-back direction relative to the outer tube 2 without rotating.

[0111] See appendix Figure 3 Alternatively, the adjusting device 28 can control the inner guide rod 1 to move relative to the outer guide tube 2 in the front-back direction without rotating. Figure 3 In this design, the rear part of the outer sleeve 2 is fixedly connected to the operating handle 27. A rack 35 is disposed within the inner cavity of the operating handle 27, and the rack 35 is fixedly connected to the inner guide rod 1. A first knob 31 is rotatably connected to the operating handle 27 via a knob pivot 36. A gear 34, coaxial with the knob pivot 36, is fixed to the first knob 31, and the gear 34 meshes with the rack 35. When the first knob 31 is rotated in both directions, the gear 34 drives the rack 35 to move forward and backward relative to the operating handle 27, thereby causing the inner guide rod 1, which is fixedly connected to the rack 35, to move forward and backward relative to the outer sleeve 2.

[0112] See also the appendix Figure 3 Another adjustment device (not shown) is designed. Adjustment device 28 controls the outer sleeve 2 to move forward and backward relative to the inner guide rod 1 without rotating. The rear end of the inner guide rod 1 is fixedly connected to the rear of the operating handle 27. A rack 35 is provided in the inner cavity of the operating handle 27, and the rack 35 is fixedly connected to the rear end of the outer sleeve 2. A first knob 31 is rotatably connected to the operating handle 27 via a knob pivot 36. A gear 34 coaxial with the knob pivot 36 is fixed to the first knob 31, and the gear 34 meshes with the rack 35. When the first knob 31 is rotated in both directions, the gear 34 drives the rack 35 to move forward and backward relative to the operating handle 27, thereby causing the outer sleeve 2, which is fixedly connected to the rack 35, to move forward and backward relative to the inner guide rod 1.

[0113] See appendix Figure 29 The rear end of the operating handle 27 is rotatably connected to a fourth knob 39, which prevents it from moving forward or backward. The rear part of the inner guide rod 1 is fixedly connected to the fourth knob 39, and the rear part of the outer tube 2 is fixedly connected to the front operating handle 27. When the fourth knob 39 is rotated in the forward or reverse direction relative to the operating handle 27, the inner guide rod 1 can only rotate relative to the outer tube 2 but cannot move forward or backward. When this device is inserted into the human digestive tract, with the inner wall of the digestive tract as a reference, the support frame 4 does not rotate. The adjusting device 28 controls the inner guide rod 1 to rotate relative to the outer tube 2, thereby driving the support frame 4 to switch between a contraction working state and an expansion working state.

[0114] You can also refer to the appendix Figure 29Another similar adjustment device 28 is designed, with the fourth knob 39 located in the middle of the operating handle 27, so that the fourth knob 39 is rotatably connected to the middle of the operating handle 27 and is prohibited from moving back and forth. The outer tube 2 is fixedly connected to the fourth knob 39, and the rear end of the inner guide rod 1 is fixed to the operating handle 27. The adjustment device 28 is used to drive the outer tube 2 to be rotatably connected to the inner guide rod 1 and is prohibited from moving back and forth. When this device is inserted into the human digestive tract, with the inner wall of the digestive tract as a reference, the support frame 4 does not rotate, and the adjustment device 28 controls the outer tube 2 to rotate relative to the inner guide rod 1, thereby driving the support frame 4 to switch between the contraction working state and the expansion working state.

[0115] When the outer tube 2 and the inner guide rod 1 are connected by threads, especially when the front part of the outer tube 2 and the inner guide rod 1 are connected by threads, the adjusting device 28 can also drive the inner guide rod 1 to move back and forth and rotate relative to the outer tube 2.

[0116] See appendix Figure 28 The front of the operating handle 27 is fixedly connected to the rear end of the outer sleeve 2, and the rear of the operating handle 27 is threadedly connected to a third knob 38. The pitch of this thread is equal to the pitch of the threaded connection between the outer sleeve 2 and the inner guide rod 1. The rear of the inner guide rod 1 is fixedly connected to the third knob 38. When the third knob 38 is rotated in both directions, the third knob 38 spirally drives the inner guide rod 1 to rotate and move back and forth relative to the outer sleeve 2. When this device is inserted into the human digestive tract, with the inner wall of the digestive tract as a reference, the support frame 4 does not rotate. When the adjusting device 28 controls the inner guide rod 1 to rotate and move back and forth relative to the outer sleeve 2 (i.e., threaded movement), it can drive the support frame 4 to switch between a contraction working state and an expansion working state.

[0117] You can also refer to the appendix Figure 28 Another adjustment device 28 is designed, in which an inner guide rod 1 is fixedly connected to the rear end of the operating handle 27, and a third knob 38 is threadedly connected to the middle of the operating handle 27. The pitch of this thread is equal to the pitch of the threaded connection between the outer tube 2 and the inner guide rod 1. The rear part of the outer tube 2 is fixedly connected to the third knob 38. When the third knob 38 is rotated in both directions, the third knob 38 spirally drives the outer tube 2 to move spirally relative to the inner guide rod 1. When this device is inserted into the human digestive tract, with the inner wall of the digestive tract as a reference, the support frame 4 does not rotate. When the adjustment device 28 controls the outer tube 2 to both rotate and move back and forth (i.e., spiral movement) relative to the inner guide rod 1, it can drive the support frame 4 to switch between a contraction working state and an expansion working state.

[0118] According to the various control methods corresponding to the aforementioned adjustment device 28, when the inner guide rod 1 or the outer sleeve 2 has relative movement, the connection structure between the front connecting seat 15 and the inner guide rod 1 has one or a combination of the following four forms: the front connecting seat 15 is fixedly connected to the inner guide rod 1; the front connecting seat 15 is slidably connected to the inner guide rod 1 in the front-back direction but is prohibited from rotating (for example, by a side guide rod that is parallel to and fixedly connected to the inner guide rod 1, the side guide rod is slidably connected to the front connecting seat 15); the inner guide rod 1 is rotatably connected within the front connecting seat 15 but is prohibited from sliding in the front-back direction (for example, the front connecting seat 15 is sleeved on the inner guide rod 1, and retaining rings are respectively provided on the front and rear sides of the front connecting seat 15, the two retaining rings are respectively fixed on the inner guide rod 1, then the two retaining rings are used to restrict the front connecting seat 15 from sliding in the front-back direction of the inner guide rod 1); the inner guide rod 1 and the front connecting seat 15 are rotatably connected by threads.

[0119] According to the various control methods corresponding to the aforementioned adjustment device 28, when controlling the relative movement of the inner guide rod 1 or the outer tube 2, the connection structure between the rear connecting seat 13 and the outer tube 2 has one or a combination of the following four forms: the rear connecting seat 13 is fixedly connected to the outer tube 2; the rear connecting seat 13 is slidably connected to the outer tube 2 in the front-back direction but is prohibited from rotating (for example, by a side guide rod that is parallel to and fixedly connected to the outer tube 2, the side guide rod is slidably connected to the rear connecting seat 13); the outer tube 2 is rotatably connected within the rear connecting seat 13 but is prohibited from sliding in the front-back direction (for example, the rear connecting seat 13 is sleeved on the outer tube 2, and retaining rings are respectively provided on the front and rear sides of the rear connecting seat 13, the two retaining rings are respectively fixed on the outer tube 2, and the two retaining rings are used to restrict the rear connecting seat 13 from sliding in the front-back direction of the outer tube 2); the outer tube 2 and the rear connecting seat 13 are rotatably connected by threads.

[0120] The selection of the four connection structures or combinations thereof between the front connecting seat 15 and the inner guide rod 1, and the selection of the four connection structures or combinations thereof between the rear connecting seat 13 and the outer sleeve 2, must satisfy the requirement that when the adjusting device 28 drives the inner guide rod 1 or the outer sleeve 2 to have relative movement, the distance between the rear connecting seat 13 and the front connecting seat 15 changes, without causing relative rotation between the rear connecting seat 13 and the front connecting seat 15, so as to avoid twisting the expandable component 3.

[0121] As one example, see Appendix Figure 4 To be continued Figure 12 The front connecting seat 15 is fixedly connected to the front part of the inner guide rod 1, and the rear connecting seat 13 is fixedly connected to the front part of the outer sleeve 2. See attached document. Figure 3The adjusting device 28 allows the inner guide rod 1 to move (slide) only in the back-and-forth direction relative to the outer sleeve 2, thus controlling the support frame 4 between two working states. (See appendix for details.) Figure 26 The adjusting device 28 allows the outer sleeve 2 to move (slide) relative to the inner guide rod 1 only in the back-and-forth direction, and can also control the support frame 4 to change between two working states.

[0122] As another embodiment, see Appendix Figure 23 and attached Figure 24 The front part of the outer tube 2 is connected to the inner guide rod 1 by a thread. The adjusting device 28 allows the inner guide rod 1 to move and rotate relative to the outer tube 2 in both the front-back direction and the rotation direction (i.e., helical motion, see appendix). Figure 28 See appendix for further details. Figure 23 and attached Figure 24 The front connecting seat 15 is sleeved on the inner guide rod 1, allowing the inner guide rod 1 to rotate within the front connecting seat 15. The rear connecting seat 13 is fixedly sleeved on the front end of the outer sleeve 2. The adjusting device 28 controls the threaded movement of the inner guide rod 1 relative to the outer sleeve 2. A side guide rod is fixedly connected to the side of the outer sleeve 2, and the side guide rod is parallel to the inner guide rod 1. The rear connecting seat 13 is slidably connected to the side guide rod in the front-to-back direction. The side guide rod also passes through the front connecting seat 15, allowing the inner guide rod 1 to rotate relative to the front connecting seat 15. The side guide rod includes a first side guide rod 25 and a second side guide rod 26 located on both sides of the outer sleeve 2. When the inner guide rod 1 rotates in both directions relative to the outer sleeve 2, the threaded connection between the two allows the rear connecting seat 13 to move relative to the front connecting seat 15 in the front-to-back direction, and the two side guide rods prevent the two connecting seats from rotating relative to each other.

[0123] The third embodiment is shown in the appendix. Figure 21 and appendix Figure 22 The front part of the outer tube 2 is connected to the inner guide rod 1 by a thread. The adjusting device 28 allows the inner guide rod 1 to move and rotate relative to the outer tube 2 in both the front-back direction and the rotation direction (i.e., helical motion, see appendix). Figure 28The front connecting seat 15 is sleeved on the inner guide rod 1 and threadedly connected to the inner guide rod 1, allowing the inner guide rod 1 to rotate within the front connecting seat 15. The rear connecting seat 13 is sleeved on the front end of the outer sleeve 2 and fixedly connected to it. A side guide rod is fixedly connected to the side of the outer sleeve 2, and the side guide rod is parallel to the inner guide rod 1. Both the front connecting seat 15 and the rear connecting seat 13 are slidably connected to the side guide rod in the front-back direction, so that the front connecting seat 15 and the rear connecting seat 13 can only move relative to each other in the front-back direction but are prohibited from rotating relative to each other. The side guide rod includes a first side guide rod 25 and a second side guide rod 26 located on both sides of the outer sleeve 2.

[0124] The fourth embodiment is not shown in the figure. The front part of the outer tube 2 is connected to the inner guide rod 1 by a thread. The adjusting device 28 allows the outer tube 2 to move and rotate (i.e., helical motion) relative to the inner guide rod 1 in both the front-to-back direction. The rear connecting seat 13 is sleeved on the outer tube 2, allowing the outer tube 2 to rotate relative to the rear connecting seat 13 while preventing it from moving in the front-to-back direction. Another front connecting seat 15 is fixedly connected to the inner guide rod 1.

[0125] See appendix Figure 17 Appendix Figure 18 In the fifth embodiment, the outer sleeve 2 is connected to the inner guide rod 1 in a manner that allows only rotation and prohibits movement in the front-to-back direction. The adjusting device 28 controls the outer sleeve 2 to only rotate relative to the inner guide rod 1. A side guide rod parallel to the inner guide rod 1 is fixedly connected to the side portion of the inner guide rod 1. The front connecting seat 15 and the rear connecting seat 13 are both sleeved on the outer sleeve 2. The side guide rods include a first side guide rod 25 and a first side guide rod 26 located on both sides of the outer sleeve 2, respectively. The front connecting seat 15 is slidably connected to the first side guide rod 25 and the first side guide rod 26 in the front-to-back direction, such that the front connecting seat 15 can only move in the front-to-back direction relative to the inner guide rod 1 but is prohibited from rotating. The front connecting seat 15 is threadedly connected to the outer sleeve 2 via a first screw 21. The rear connecting seat 13 is sleeved on the outer sleeve 2 in a manner that prohibits movement in the front-to-back direction, and the outer sleeve 2 is rotatably connected relative to the rear connecting seat 13.

[0126] See appendix Figure 19 Appendix Figure 20In the sixth embodiment, the outer sleeve 2 is connected to the inner guide rod 1 in a manner that allows only rotation and prohibits movement in the front-to-back direction. The adjusting device 28 controls the outer sleeve 2 to only rotate relative to the inner guide rod 1. A side guide rod parallel to the inner guide rod 1 is fixedly connected to the side portion of the inner guide rod 1. The side guide rod includes a first side guide rod 25 and a first side guide rod 26 located on both sides of the outer sleeve 2. The front connecting seat 15 and the rear connecting seat 13 are slidably connected to the first side guide rod 25 and the first side guide rod 26 in the front-back direction, so that the front connecting seat 15 and the rear connecting seat 13 can only move in the front-back direction relative to the inner guide rod 1 but are prohibited from rotating. The front connecting seat 15 and the rear connecting seat 13 are both sleeved on the outer sleeve 2 and threadedly connected to it. The front connecting seat 15 is connected to the outer sleeve 2 through the first thread 21, and the rear connecting seat 13 is connected to the outer sleeve 2 through the second thread 22. The first thread 21 and the second thread 22 have opposite thread directions. After the outer sleeve 2 rotates one revolution, the front connecting seat 15 and the rear connecting seat 13 move relative to each other by two thread pitches.

[0127] Referring to the accompanying drawings, when the supporting frame 4 is in a contracted or / and expanded working state, the side rods 9 on each linkage mechanism 5 are parallel to the front of the inner guide rod 1. The side rods 9 are arranged circumferentially around the axis of the inner guide rod 1. Specifically, when the supporting frame 4 is in an expanded working state, the side rods 9 support the electrode array membrane 16 so that the outer surface of the electrode array membrane 16 is as cylindrical as possible to adhere closely to the inner wall of the digestive tract. When the supporting frame 4 is in a contracted working state, the electrode array membrane 16 is rolled or / and folded onto the supporting frame 4. The substrate of the electrode array membrane 16 is a commonly used flexible polymer insulating film, such as polyimide or PET material. Various electrode array membranes 16 and connection methods with the supporting frame 4 can be selected. When the supporting frame 4 is in a contracted working state, the electrode array membrane 16 has a folded and rolled structure (as shown in the attached figures). Figure 13 (as shown); or the electrode array film 16 has a folded structure (as shown in the attached image). Figure 14 (as shown); or the electrode array film 16 has a wound structure (as shown in the attached image). Figure 15 As shown, the connection relationship between the electrode array film 16 and the support frame 4, as well as the state of the electrode array film 16 when it is contracted, are only some of the listed embodiments.

[0128] See appendix Figure 15 and attached Figure 16The electrode array membrane 16 is shaped like a spiral spring and has a radially self-contracting elastic force. The electrode array membrane 16 is wound around each of the side rods 9. The inner end 29 of the electrode array membrane is connected to the side rod 9, and the outer end 30 of the electrode array membrane is a free end. During the transition of the support frame 4 from a contracted working state to an expanded working state, each of the side rods 9 expands the electrode array membrane 16 outwards, causing the diameter of the outermost layer of the electrode array membrane 16 on each side rod 9 to gradually increase, and the total number of turns of the electrode array membrane 16 to gradually decrease. During the transition of the support frame 4 from an expanded working state to a contracted working state, the diameter of the outermost layer of the electrode array membrane 16 gradually decreases due to the self-contracting elastic force of the electrode array membrane 16, and the total number of turns of the electrode array membrane 16 gradually increases. To enable the electrode array membrane 16 to have a self-contracting elastic force, the electrode array membrane 16 is provided with shape memory alloy strips, for example, made of nickel-titanium alloy. When the support frame 4 is in the contracted working state, the attached... Figure 15 The shape of the electrode array film 16 described herein is the shape memory shape of a shape memory alloy strip.

[0129] See appendix Figure 1 -Appendix Figure 2 , attached Figure 4 -Appendix Figure 12 , attached Figure 17 -Appendix Figure 24 The inner guide rod 1 has a front guide cap 32 made of silicone material connected to its front end, and the outer tube 2 has a rear guide cap 33 made of silicone material connected to its front end. The soft front and rear guide caps 32 and 33 facilitate guiding the expandable component 3 forward or backward within the curved digestive tract without damaging the inner wall tissue. When the support frame 4 is in the retracted working state, the front and rear guide caps 32 and 33 respectively cover the front and rear ends of the support frame 4. The front and rear guide caps 32 and 33 have approximately conical outer surfaces. The outer diameter of the conical outer surface of the front guide cap 32 gradually decreases from back to front, while the outer diameter of the conical outer surface of the rear guide cap 33 gradually decreases from front to back.

[0130] As attached Figure 2As shown, the length of the side rod 9 in the front-back direction is approximately equal to the width of the electrode array membrane 16 in the front-back direction, with a difference of less than 1.5 mm, preferably less than 0.5 mm or zero. Because the support frame 4 is made of a hard metal material, such as stainless steel, it has very little radial elasticity. In the contracted working state, the shorter the length of the support frame 4 in the front-back direction, the more advantageous it is for advancing or retreating within the curved digestive tract, and the less likely it is to damage the inner wall tissue of the digestive tract. The outer tube 2 and the inner guide rod 1 are radially elastic due to their slenderness, and can bend appropriately with the curvature of the digestive tract. Assuming that the width of the electrode array membrane 16 is the same in the front-back direction, whether the support frame 4 is in the contracted or expanded working state, the length of the side rod 9 in the front-back direction represents the front-back length of the expandable component 3 and remains unchanged. Therefore, the structure of the support frame 4 in this device makes its length in the front-back direction shorter, especially in the contracted working state, which is one of the advantages of this invention.

[0131] To facilitate easier bending of the inner guide rod and outer sleeve as they move forward or backward within the curved digestive tract without damaging the tract wall, the rear inner guide rod 42 and the rear outer sleeve 50 (or outer sleeve 2) in the following two embodiments are made of easily bendable non-rigid components. These non-rigid components are suitable for transmitting torque. The definition of an easily bendable non-rigid component is: when the rear part of the rear inner guide rod 42 rotates, the front part of the front inner guide rod 41 also rotates synchronously; when the rear part of the rear outer sleeve 50 rotates, the front part of the front outer sleeve 49 also rotates synchronously; when the rear part of the outer sleeve 2 rotates, the front part of the outer sleeve 2 also rotates synchronously.

[0132] The following embodiment uses the inner guide rod 1 as the active driving component. By rotating the inner guide rod 1, the relative rotation between the inner guide rod 1 and the outer sleeve 2 is achieved, further allowing the distance between the front connecting seat 15 and the rear connecting seat 13 to change. See appendix. Figure 29 When the fourth knob 39 is rotated in either the forward or reverse direction relative to the operating handle 27, the inner guide rod 1 (rear inner guide rod 42) can only rotate relative to the outer tube 2 but cannot move forward or backward. This rotational torque can be transmitted through the inner guide rod 1 (rear inner guide rod 42) to the front inner guide rod 41, causing the front inner guide rod 41 to rotate relative to the outer tube 2. See appendix. Figure 43 Appendix Figure 44 The last section of the inner guide rod 42 near the proximal end is a rigid component because it does not need to enter the digestive tract.

[0133] See appendix Figures 30-34 A device for ablation therapy of the digestive tract, comprising:

[0134] Inner guide rod 1, see attached document. Figure 43 and attached Figure 44 The inner guide rod 1 includes a front inner guide rod 41 and a rear inner guide rod 42. The rear end of the front inner guide rod 41 is connected to the front end of the rear inner guide rod 42. The front inner guide rod 41 is a rigid rod, and the rear inner guide rod 42 is a non-rigid member that is easily bent. Specifically, the rear inner guide rod 42 is formed by spirally winding a metal strip into a spring shape (as shown in the attached figure). Figure 43 Appendix Figure 44 (as shown); or as attached Figure 41 and appendix Figure 42 As shown, the rear inner guide rod 42 is replaced by the structure of the rear outer sleeve 50; various flexible tubular parts as described in US10420537B2 can also be used, the function of which is that the flexible non-rigid part can easily pass through the curved human digestive tract, and the flexible non-rigid part can also transmit torque well. When the rear inner guide rod 42 rotates, the front inner guide rod 41 can also rotate synchronously.

[0135] The outer sleeve 2 is a flexible, non-rigid component, as described in the appendix. Figure 41 and appendix Figure 42 The structure of the rear outer sleeve 50 can also be found in the appendix. Figure 43 and appendix Figure 44 The structure of the rear inner guide rod 42 can also be seen in US10420537B2, which describes easily bendable tubular components. These easily bendable, non-rigid components facilitate easy passage through the curved human digestive tract, and allow the front to rotate synchronously when the rear rotates. See appendix. Figure 41 Appendix Figure 42 The last section of the rear outer tube 50 near the proximal end is made of rigid material since it does not need to enter the digestive tract. The outer tube 2 is sleeved on the rear inner guide rod 42. The inner guide rod 1 is rotatably set relative to the outer tube 2, but the front inner guide rod 41 is prohibited from moving in the front-back direction relative to the outer tube 2.

[0136] An expandable component 3 surrounds the front inner guide rod 41 and is located outside the front inner guide rod 41, wherein the expandable component 3 includes:

[0137] The support frame 4 has a radially contracting working state and a radially expanding working state. The support frame 4 includes multiple linkage mechanisms 5, at least one of which is an X-type linkage mechanism 6. The X-type linkage mechanism 6 includes a first link 7, a second link 8, and a side link 9. The first link 7 and the second link 8 intersect. The outer ends 10 of the first link and 11 of the second link are respectively connected to the side link 9. The inner end 12 of the first link is connected to the rear connecting seat 13, and the inner end 14 of the second link is connected to... The front connecting seat 15 is connected to the front part of the front inner guide rod 41 and the two are rotatably connected by threads. The rear connecting seat 13 is fixedly connected to the front end of the outer tube 2. During the forward or reverse rotation of the inner guide rod 1 relative to the outer tube 2, the distance between the rear connecting seat 13 and the front connecting seat 15 changes, and the distance between the outer end of the first connecting rod 10 and the outer end of the second connecting rod 11 also changes. Thus, the support frame 4 changes between the contracted working state and the expanded working state.

[0138] An electrode array membrane 16 includes a plurality of electrodes 17 for receiving electrical signals. The electrode array membrane 16 is connected to a support frame 4. When the support frame 4 is in an expanded working state, the electrode array membrane 16 is stretched open. When the support frame 4 is in a contracted working state, the electrode array membrane 16 is contracted onto the support frame 4.

[0139] See appendix Figure 31 Appendix Figure 33 and attached Figure 34 The rear part of the front inner guide rod 41 is fixed with a radially outward annular protrusion rear locking block 43, which engages in a radially recessed groove on the rear connecting seat 13. Since the rear connecting seat 13 is fixedly connected to the front end of the outer sleeve 2, the rear locking block 43 can also engage in a radially recessed groove on the front end of the outer sleeve 2 (not shown). The rear locking block 43 is used to prevent the rear connecting seat 13 from moving forward or backward axially relative to the front inner guide rod 41, but allows the front inner guide rod 41 to rotate relative to the rear connecting seat 13. When the front inner guide rod 41 rotates, the front connecting seat 15 moves axially (front-back direction) under the action of the thread. The rear locking block 43 can prevent the rear connecting seat 13 or the outer sleeve 2 from moving axially (front-back direction) relative to the front inner guide rod 41, so the support frame 4 can change between a contracted working state and an expanded working state.

[0140] Otherwise, if axial movement of the rear connecting seat 13 relative to the front inner guide rod 41 is not prohibited, then for example, when the front connecting seat 15 moves axially toward the rear connecting seat 13, the support frame 4 should move from the attached... Figure 32 The contraction working state towards the attachment Figure 30 The expansion working state changes, but the side rod 9 will be subjected to radial pressure from the inner wall of the digestive tract. When this pressure is transmitted to the rear connecting seat 13 through the X-type linkage mechanism 6, its axial component will cause the rear connecting seat 13 to have a tendency to move axially backward relative to the front inner guide rod 41. Since the outer sleeve 2 is a flexible non-rigid part, its axial rigidity is poor, and it is easy to be compressed and deformed when subjected to axial force. The result is that the attached Figure 29 When the fourth knob 39 shown is rotated, the front connecting seat 15 moves axially backward, and the rear connecting seat 13 also moves axially backward relative to the front inner guide rod 41. Therefore, it is difficult to shorten the distance between the front and rear connecting seats, and it is difficult to expand the support frame.

[0141] Another structure, not shown, has the same function as the rear locking block 43 but is positioned oppositely: the rear connecting seat 13 or the front end of the outer sleeve 2 is fixed with a radially protruding rear locking block 43. The rear locking block 43 is used to prevent the rear connecting seat 13 from moving forward or axially backward relative to the front inner guide rod 41, but allows the front inner guide rod 41 to rotate relative to the rear connecting seat 13. The front inner guide rod 41 is provided with a radially recessed groove, and the rear locking block 43 is engaged in the groove on the front inner guide rod 41.

[0142] As attached Figure 31 Appendix Figure 33 As shown, the front end of the front inner guide rod 41 is connected to a front guide cap 32, and the front end of the outer tube 2 is connected to a rear guide cap 33. When the support frame 4 is in the retracted working state, the front guide cap 32 and the rear guide cap 33 respectively cover the front end and the rear end of the support frame 4. The front guide cap 32 and the rear guide cap 33 have approximately conical outer surfaces. The outer diameter of the conical outer surface of the front guide cap 32 gradually decreases from back to front, while the outer diameter of the conical outer surface of the rear guide cap 33 gradually decreases from front to back. The front inner guide rod 41 and the rear inner guide rod 42 are connected inside the rear guide cap 33, and the front end of the outer tube 2 is also located inside the rear guide cap 33.

[0143] See appendix Figure 43 Appendix Figure 44 The inner guide rod 42 in the rear section is formed into a spring shape by spirally winding a metal strip. The outer sleeve 2 can also be formed into a spring shape by spirally winding a metal strip.

[0144] See appendix Figure 41 Appendix Figure 42 The outer tube 2 is a hollow tubular component. Multiple parallel, hollowed-out strip-shaped openings 44 are spaced apart on the tube body of the outer tube 2. These openings 44 are arranged along the axial direction of the outer tube 2 and are not parallel to its centerline. The strip-shaped openings 44 are arranged in at least two rows along the axial direction of the outer tube 2, with adjacent openings 44 in adjacent rows staggered in the circumferential direction.

[0145] The aforementioned rear inner guide rod 42 can also be equipped with an attachment. Figure 41 The structure of the rear outer tube 50. To achieve easy bending within the digestive tract, various flexible tubular components as described in US10420537B2 may also be used, but not limited to. The rear inner guide rod 42 and the last section (distal section) of the rear outer tube 50 are rigid components because they need to be connected to the operating handle 27 and do not need to extend into the digestive tract.

[0146] See appendix Figures 30-34 The outer sleeve 2 is also wrapped with an outer sheath 46, and a wire (not shown) for transmitting electrical signals to the electrodes 17 on the electrode array film 16 is provided between the outer sleeve 2 and the outer sheath 46.

[0147] The following embodiment uses the outer sleeve 2 as the active driving component. By rotating the outer sleeve 2, the relative rotation between the outer sleeve 2 and the inner guide rod 1 is achieved, further allowing the distance between the front connecting seat 15 and the rear connecting seat 13 to change. (See attached diagram.) Figure 40 The adjustment device 28 has a fifth knob 51 located at the front of the operating handle 27, so that the front of the operating handle 27 is rotatably connected to the fifth knob 51 and is prohibited from moving back and forth. The rear outer tube 50 is fixedly connected to the fifth knob 51, and the rear end of the rear inner guide rod 42 is fixed to the rear end of the operating handle 27. The adjustment device 28 is used to drive the rear outer tube 50 to be rotatably connected to the rear inner guide rod 42 and is prohibited from moving back and forth.

[0148] See appendix Figures 35-39 A device for ablation therapy of the digestive tract, comprising:

[0149] Inner guide rod 1, see appendix Figures 35-39 The inner guide rod 1 includes a front inner guide rod 41 and a rear inner guide rod 42. The rear end of the front inner guide rod 41 is connected to the front end of the rear inner guide rod 42. The front inner guide rod 41 is a rigid rod, and the rear inner guide rod 42 is a non-rigid member that is easily bent. Specifically, the rear inner guide rod 42 is formed by spirally winding a metal strip into a spring shape (as shown in the attached figure). Figure 43 Appendix Figure 44 (as shown); or as attached Figure 41 and appendix Figure 42 As shown, the rear inner guide rod 42 is replaced by the structure of the rear outer sleeve 50; alternatively, flexible tubular components as described in US10420537B2 can be used, the function of which is that these flexible, non-rigid components can easily pass through the curved human digestive tract, and these flexible, non-rigid components can effectively transmit torque. See Appendix Figure 43 Appendix Figure 44 , attached Figure 41 Appendix Figure 42 The last section of the inner guide rod 42 does not need to enter the digestive tract and is made of rigid material.

[0150] Outer tube 2, see appendix Figures 35-39 , attached Figure 41 Appendix Figure 42 The outer sleeve 2 includes a front outer sleeve 49 and a rear outer sleeve 50. The rear end of the front outer sleeve 49 is connected to the front end of the rear outer sleeve 50. The front outer sleeve 49 is a rigid rod, and the rear outer sleeve 50 is a flexible, non-rigid component. The front outer sleeve 49 is sleeved on the front inner guide rod 41, and the rear outer sleeve 50 is sleeved on the rear inner guide rod 42. The outer sleeve 2 is rotatably mounted relative to the inner guide rod 1. The flexible, non-rigid outer sleeve 2 can be found in the attached diagram. Figure 41 and appendix Figure 42 The structure of the rear outer sleeve 50 can also be found in the appendix. Figure 43 and appendix Figure 44 The structure of the rear inner guide rod 42 can also be seen in the description of the easily bendable tubular components in US10420537B2. Its function is to allow this easily bendable, non-rigid component to easily pass through the curved human digestive tract and to transmit torque effectively. See Appendix. Figure 41 Appendix Figure 42 The last section of the inner guide rod 42, near the proximal end, does not need to enter the digestive tract and is made of rigid material;

[0151] Expandable component 3, see appendix Figures 35-39 It surrounds the front outer sleeve and is located outside the front outer sleeve 49, wherein the expandable component 3 includes:

[0152] Support frame 4, see appendix Figures 35-39The supporting frame 4 has a radially shrinking contraction working state and a radially expanding expansion working state; the supporting frame 4 includes multiple linkage mechanisms 5, at least one linkage mechanism 5 is an X-type linkage mechanism 6, the X-type linkage mechanism 6 includes a first link 7, a second link 8, and a side link 9, the first link 7 and the second link 8 intersect, the outer end 10 of the first link and the outer end 11 of the second link are respectively connected to the side link 9, the inner end 12 of the first link is connected to the rear connecting seat 13, and the inner end 14 of the second link is connected to the front connecting seat 1. 5. The front connecting seat 15 is fixedly connected to the front inner guide rod 41, and the rear connecting seat 13 is sleeved on the front outer sleeve 49 and the two are rotatably connected by threads. During the forward or reverse rotation of the front outer sleeve 49 relative to the front inner guide rod 41, the distance between the rear connecting seat 13 and the front connecting seat 15 changes, and the distance between the outer end 10 of the first connecting rod and the outer end 11 of the second connecting rod also changes accordingly. Thus, the support frame 4 changes between the contracted working state and the expanded working state.

[0153] An electrode array membrane 16 includes a plurality of electrodes 17 for receiving electrical signals. The electrode array membrane 16 is connected to a support frame 4. When the support frame 4 is in an expanded working state, the electrode array membrane 16 is stretched open. When the support frame 4 is in a contracted working state, the electrode array membrane 16 is contracted onto the support frame 4.

[0154] See attached Figure 36 Appendix Figure 38 Appendix Figure 39 The front outer sleeve 49 is fixed with an annular and radially outward protruding front locking block 47. The front locking block 47 engages in the radially recessed groove of the front connecting seat 15. Since the front inner guide rod 41 is fixed as a whole with the front connecting seat 15, the front locking block 47 can also be radially inward protruding and engaging in the groove on the front inner guide rod 41 (not shown). This allows the front locking block 47 to prevent the front outer sleeve 49 from moving forward or axially backward relative to the front connecting seat 15, but allows the front outer sleeve 49 to rotate relative to the front connecting seat 15.

[0155] Otherwise, if axial movement of the front outer sleeve 49 relative to the front connecting seat 15 is not prohibited, then, for example, when the rear connecting seat 13 moves axially toward the front connecting seat 15, the support frame 4 should move from the attached... Figure 38 The contraction working state towards the attachment Figure 36The expansion working state changes, but the side rod 9 will be subjected to radial pressure from the inner wall of the digestive tract. When this pressure is transmitted to the front connecting seat 15 through the X-type linkage mechanism 6, its axial component will cause the front connecting seat 15 to have a tendency to move forward axially relative to the front outer sleeve 49. Since the front connecting seat 15 is fixed on the front inner guide rod 41, and the rear inner guide rod 42 is a non-rigid part that is easy to bend, its axial rigidity is poor, and it is easy to be stretched and deformed when subjected to axial tensile force. The result is that the attached Figure 40 When the fifth knob 51 shown is turned, the rear connecting seat 13 moves forward axially, and the front connecting seat 15 is also subjected to force and moves forward axially relative to the front outer sleeve 49. Therefore, it is difficult to shorten the distance between the front and rear connecting seats, and it is difficult to expand the support frame.

[0156] Another structure, not shown, has the same function as the aforementioned front locking block 47 but is configured in the opposite way: a front locking block 47 is fixed on the front connecting seat 15 or the front inner guide rod 41. The front locking block 47 is annular and radially protruding. The front locking block 47 engages with the radial recess of the front outer sleeve 49, thereby preventing the front outer sleeve 49 from moving forward or axially backward relative to the front connecting seat 15, but allowing the front outer sleeve 49 to rotate relative to the front connecting seat 15.

[0157] See attached Figure 36 and attached Figure 38 The front end of the front inner guide rod 41 is connected to a front guide cap 32, and the front end of the rear outer tube 50 is connected to a rear guide cap 33. When the support frame 4 is in the retracted working state, the front guide cap 32 and the rear guide cap 33 cover the front and rear ends of the support frame 4, respectively. The front guide cap 32 and the rear guide cap 33 have approximately conical outer surfaces. The outer diameter of the conical outer surface of the front guide cap 32 gradually decreases from back to front, while the outer diameter of the conical outer surface of the rear guide cap 33 gradually decreases from front to back. The front inner guide rod 41 and the rear inner guide rod 42 are connected inside the rear guide cap 33, and the front outer tube 49 and the rear outer tube 50 are also connected inside the rear guide cap 33.

[0158] See appendix Figure 43 and attached Figure 44 The rear inner guide rod 42 or the rear outer sleeve 50 is formed by spirally winding metal strips to form a spring shape.

[0159] See appendix Figure 41 and attached Figure 42The rear outer sleeve 50 or the rear inner guide rod 42 is a hollow tubular component. Multiple parallel, hollowed-out strip-shaped openings 44 are spaced apart on the tube body of the rear outer sleeve 50 or the rear inner guide rod 42. These strip-shaped openings 44 are arranged along the axial direction of the rear outer sleeve 50 or the rear inner guide rod 42, and are not parallel to the centerline of the rear outer sleeve 50 or the rear inner guide rod 42. The strip-shaped openings 44 are arranged in at least two rows along the axial direction of the rear outer sleeve 50 or the rear inner guide rod 42, with adjacent two strip-shaped openings 44 in adjacent rows staggered in the circumferential direction.

[0160] See appendix Figure 36 and attached Figure 38 The outer side of the rear outer tube 50 is also wrapped with an outer sheath 46, and a wire for transmitting electrical signals to the electrodes 17 on the electrode array film 16 is provided between the rear outer tube 50 and the outer sheath 46.

[0161] See appendix Figure 36 The inner guide rod 1 has an axial guide wire through hole 48 in the center for placing surgical guide wires. An insulating layer 45 is fixedly attached to the inner wall of the guide wire through hole 48.

[0162] In the two embodiments described above, the first link 7 and the second link 8 are rotatably connected at their intersection via a pivot. Each link mechanism 5 is an X-type link mechanism 6, and there are 4-10 link mechanisms 5. One of the outer ends of the first link 10 and the second link 11 is slidably connected to the side rod 9, and the other outer end is rotatably connected to the side rod 9 via a pivot. The side rod 9 has a guide groove 18 extending along its front-rear direction, and one of the outer ends of the first link 10 and the second link 11 is slidably connected to the side rod 9 via the guide groove 18. Alternatively, the outer ends of the first link 10 and the second link 11 can be slidably connected to the front and rear parts of the side rod 9, respectively. The front and rear portions of the side rod 9 are respectively provided with a first arc-shaped guide groove 19 and a second arc-shaped guide groove 20. The outer end portion 10 of the first connecting rod and the outer end portion 11 of the second connecting rod are slidably connected to the front and rear portions of the side rod 9 through the first arc-shaped guide groove 19 and the second arc-shaped guide groove 20, respectively. The first arc-shaped guide groove 19 bends from back to front inward, and the second arc-shaped guide groove 20 bends from back to front inward.

[0163] The side rod 9 is a telescopic rod formed by connecting at least two rods, which has a variable length in the front-to-back direction. The outer end 10 of the first connecting rod and the outer end 11 of the second connecting rod are rotatably connected to the front end and the rear end of the telescopic rod, respectively, via pivots. The inner end 12 of the first connecting rod is rotatably connected to the rear connecting seat 13 via a pivot, and the inner end 14 of the second connecting rod is rotatably connected to the front connecting seat 15 via a pivot.

[0164] The inner end 12 of the first link is fixedly connected to the rear connecting seat 13, and / or the inner end 14 of the second link is fixedly connected to the front connecting seat 15. When the support frame 4 changes between the contracted working state and the expanded working state, the inner end 12 of the first link or / and the inner end 14 of the second link are allowed to deform and bend.

[0165] The device for ablation treatment of the digestive tract further includes an operating handle 27 connected to the rear of the inner guide rod 1 and / or the rear of the outer tube 2. The operating handle 27 is provided with an adjustment device 28, which is used to adjust the relative rotation between the outer tube 2 and the inner guide rod 1, or to adjust the relative rotation between the inner guide rod 1 and the outer tube 2.

[0166] When the support frame 4 is in a contracted working state and / or an expanded working state, the side rods 9 on each linkage mechanism 5 are parallel to the front of the inner guide rod 1, and the side rods 9 are arranged in a circumferential direction around the axis of the inner guide rod 1.

[0167] When the support frame 4 is in the retracted working state, the electrode array film 16 is wound or / and folded on the support frame 4.

[0168] The electrode array membrane 16 is shaped like a spiral spring, possessing radial self-contracting elastic force. The electrode array membrane 16 is wound around each of the side rods 9, with its inner end 29 connected to one of the side rods 9, and its outer end 30 being a free end. During the transition from a contracted to an expanded working state of the support frame 4, each side rod 9 expands the electrode array membrane 16 outwards, causing the diameter of the outermost layer of the electrode array membrane 16 on each side rod 9 to gradually increase, and the total number of turns of the electrode array membrane 16 to gradually decrease. Conversely, during the transition from an expanded to a contracted working state of the support frame 4, the self-contracting elastic force of the electrode array membrane 16 causes the diameter of the outermost layer of the electrode array membrane 16 to gradually decrease, and the total number of turns of the electrode array membrane 16 to gradually increase. The electrode array membrane 16 is provided with shape memory alloy strips. When the support frame 4 is in the contracted working state, the shape of the electrode array membrane 16 is the shape memory shape of the shape memory alloy strips.

[0169] The length of the side rod 9 in the front-back direction is approximately equal to the width of the electrode array film 16 in the front-back direction, with a difference of less than 1.5 mm, preferably less than 0.5 mm or equal.

[0170] The aforementioned device for ablation therapy of the digestive tract, including the inner guide rod 1, outer cannula 2, and expandable component 3, are all disposable interventional surgical products. Therefore, as a system for ablation therapy of the digestive tract, it also includes a signal generator (not shown) located proximally to the operator, configured to generate an electrical signal for treatment and electrically connected to electrode 17. The aforementioned device for ablation therapy of the digestive tract is more suitable for ablation therapy of the duodenum.

[0171] The aforementioned device is a disposable product that can damage or ablate tissue under the action of an electric field. Certain diseased tissues in the digestive tract can be ablated using the aforementioned device without the need for open abdominal surgery or perforation minimally invasive surgery, as described in CN114786605A. The aforementioned device can ablate the villi of the duodenum to a depth of about 1 mm, thereby reducing the absorption of food by the duodenum, which can lower blood sugar and reduce weight. Therefore, the present invention has the use of electric field therapy for duodenal in the treatment of diabetes, and the aforementioned use of electric field therapy for duodenal in the treatment of obesity.

Claims

1. A device for ablation therapy of the digestive tract, characterized in that, It includes: The inner guide rod includes a front inner guide rod and a rear inner guide rod. The rear end of the front inner guide rod is connected to the front end of the rear inner guide rod. The front inner guide rod is a rigid rod, and the rear inner guide rod is a non-rigid member that is easy to bend. When the rear part of the rear inner guide rod rotates, the front part of the front inner guide rod also rotates synchronously. The outer tube is a flexible, non-rigid component, and when the rear of the outer tube rotates, the front of the outer tube also rotates synchronously; the outer tube is fitted onto the rear inner guide rod, and the inner guide rod is rotatably arranged relative to the outer tube. An expandable component surrounds the inner front guide rod and is located outside the inner front guide rod, wherein the expandable component includes: A support frame has a radially contracting working state and a radially expanding working state. The support frame includes multiple linkage mechanisms, at least one of which is an X-type linkage mechanism. The X-type linkage mechanism includes a first link, a second link, and a side link. The first and second links intersect, and the outer ends of the first and second links are respectively connected to the side link. The inner end of the first link is connected to a rear connecting seat, and the inner end of the second link is connected to a front connecting seat. The front connecting seat is sleeved on the front part of the inner guide rod and the two are rotatably connected by a thread. The rear connecting seat is fixedly connected to the front end of the outer sleeve. During the forward or reverse rotation of the inner guide rod relative to the outer sleeve, the distance between the rear and front connecting seats changes, and the distance between the outer ends of the first and second links also changes accordingly. Therefore, the support frame changes between the contracting and expanding working states. An electrode array membrane includes multiple electrodes for receiving electrical signals. The electrode array membrane is connected to a support frame. When the support frame is in an expanded working state, the electrode array membrane is stretched open. When the support frame is in a contracted working state, the electrode array membrane contracts onto the support frame.

2. The device for ablation therapy of the digestive tract according to claim 1, characterized in that, A rear locking block is fixed on the front inner guide rod. The rear locking block is used to prevent the rear connecting seat from moving forward or backward axially relative to the front inner guide rod, but allows the front inner guide rod to rotate relative to the rear connecting seat. The rear locking block is engaged with the rear connecting seat or the front end of the outer sleeve.

3. The apparatus for ablation therapy of the digestive tract according to claim 1, characterized in that, The rear connecting seat or the front part of the outer sleeve is fixed with a rear locking block. The rear locking block is used to prevent the rear connecting seat from moving forward or backward axially relative to the front inner guide rod, but allows the front inner guide rod to rotate relative to the rear connecting seat. The rear locking block is engaged with the front inner guide rod.

4. The apparatus for ablation therapy of the digestive tract according to claim 1, characterized in that, The front end of the inner guide rod is connected to a front guide cap, and the front end of the outer tube is connected to a rear guide cap. When the support frame is in a retracted working state, the front guide cap and the rear guide cap cover the front and rear ends of the support frame, respectively. The front guide cap and the rear guide cap have approximately conical outer surfaces. The outer diameter of the conical outer surface of the front guide cap gradually decreases from back to front, while the outer diameter of the conical outer surface of the rear guide cap gradually decreases from front to back. The inner guide rod and the inner guide rod are connected inside the rear guide cap.

5. The apparatus for ablation therapy of the digestive tract according to claim 1, characterized in that, The inner guide rod or outer sleeve of the rear section is formed by spirally winding a metal strip into a spring shape.

6. The apparatus for ablation therapy of the digestive tract according to claim 1, characterized in that, The outer tube or the rear inner guide rod is a hollow tubular component. The outer tube or the rear inner guide rod has multiple hollow and parallel strip openings spaced apart on its body. The multiple strip openings are arranged along the axial direction of the outer tube or the rear inner guide rod, and the strip openings are not parallel to the axis of the outer tube or the rear inner guide rod.

7. The apparatus for ablation therapy of the digestive tract according to claim 6, characterized in that, The strip openings are arranged in at least two rows along the axial direction of the outer sleeve or the rear inner guide rod, with adjacent two strip openings in adjacent rows staggered in the circumferential direction.

8. The apparatus for ablation therapy of the digestive tract according to claim 1, characterized in that, The outer sleeve is further wrapped with an outer sheath, and a wire for transmitting electrical signals to the electrodes on the electrode array film is provided between the outer sleeve and the outer sheath.

9. A device for ablation therapy of the digestive tract, characterized in that, It includes: The inner guide rod includes a front inner guide rod and a rear inner guide rod. The rear end of the front inner guide rod is connected to the front end of the rear inner guide rod. The front inner guide rod is a rigid rod, and the rear inner guide rod is a non-rigid member that is easy to bend. When the rear part of the rear inner guide rod rotates, the front part of the front inner guide rod also rotates synchronously. The outer tube includes a front outer tube and a rear outer tube. The rear end of the front outer tube is connected to the front end of the rear outer tube. The front outer tube is a rigid rod, and the rear outer tube is a non-rigid member that is easy to bend. When the rear part of the rear outer tube rotates, the front part of the front outer tube also rotates synchronously. The front outer sleeve is fitted onto the front inner guide rod, and the rear outer sleeve is fitted onto the rear inner guide rod. The outer sleeve is rotatably mounted relative to the inner guide rod. An expandable component surrounds the front outer sleeve and / or the front inner guide rod and is located outside the front outer sleeve and / or the front inner guide rod, wherein the expandable component comprises: A support frame has a radially contracted working state and a radially expanded working state. The support frame includes multiple linkage mechanisms, at least one of which is an X-type linkage mechanism. The X-type linkage mechanism includes a first link, a second link, and a side link. The first and second links intersect, with the outer ends of the first and second links respectively connected to the side link. The inner end of the first link is connected to a rear connecting seat, and the inner end of the second link is connected to a front connecting seat. The front connecting seat is fixedly connected to the front inner guide rod, and the rear connecting seat is sleeved on the front outer sleeve, with the two being threaded and rotatably connected. During the forward or reverse rotation of the front outer sleeve relative to the front inner guide rod, the distance between the rear and front connecting seats changes, as does the distance between the outer ends of the first and second links, thus causing the support frame to switch between the contracted and expanded working states. An electrode array membrane includes multiple electrodes for receiving electrical signals. The electrode array membrane is connected to a support frame. When the support frame is in an expanded working state, the electrode array membrane is stretched open. When the support frame is in a contracted working state, the electrode array membrane contracts onto the support frame.

10. The apparatus for ablation therapy of the digestive tract according to claim 9, characterized in that, The front outer tube is fixed with a front locking block, which is used to prevent the front outer tube from moving forward or backward axially relative to the front connecting seat, but allows the front outer tube to rotate relative to the front connecting seat. The front locking block is engaged with the front connecting seat or the front inner guide rod.

11. The apparatus for ablation therapy of the digestive tract according to claim 9, characterized in that, A front locking block is fixed on the front connecting seat or the front inner guide rod. The front locking block is used to prevent the front outer tube from moving forward or backward axially relative to the front connecting seat, but allows the front outer tube to rotate relative to the front connecting seat. The front locking block is engaged with the front outer tube.

12. The apparatus for ablation therapy of the digestive tract according to claim 9, characterized in that, The front end of the inner guide rod is connected to a front guide cap, and the front end of the outer sleeve is connected to a rear guide cap. When the support frame is in a retracted working state, the front and rear guide caps cover the front and rear ends of the support frame, respectively. The front and rear guide caps have approximately conical outer surfaces. The outer diameter of the conical outer surface of the front guide cap gradually decreases from back to front, while the outer diameter of the conical outer surface of the rear guide cap gradually decreases from front to back. The inner guide rod and the inner guide rod are connected inside the rear guide cap, and the outer sleeve is also connected inside the rear guide cap.

13. The apparatus for ablation therapy of the digestive tract according to claim 9, characterized in that, The rear inner guide rod or the rear outer sleeve is formed by spirally winding metal strips to create a spring shape.

14. The apparatus for ablation therapy of the digestive tract according to claim 9, characterized in that, The rear outer tube or the rear inner guide rod is a hollow tubular component. The tube body of the rear outer tube or the rear inner guide rod has multiple hollow and parallel strip openings spaced apart. The multiple strip openings are arranged along the axial direction of the rear outer tube or the rear inner guide rod, and the strip openings are not parallel to the axis of the rear outer tube or the rear inner guide rod.

15. The apparatus for ablation therapy of the digestive tract according to claim 14, characterized in that, The strip openings are arranged in at least two rows along the axial direction of the rear outer sleeve or the rear inner guide rod, with adjacent strip openings in adjacent rows staggered in the circumferential direction.

16. The apparatus for ablation therapy of the digestive tract according to claim 9, characterized in that, The outer side of the rear outer tube is also wrapped with an outer sheath, and a wire for transmitting electrical signals to the electrodes on the electrode array film is provided between the rear outer tube and the outer sheath.

17. The apparatus for ablation therapy of the digestive tract according to claim 1 or 9, characterized in that, The inner guide rod has an axial guide wire through hole in the center, and an insulating layer is fixedly attached to the inner wall of the guide wire through hole.

18. The apparatus for ablation therapy of the digestive tract according to claim 1 or 9, characterized in that, The first and second links are rotatably connected at their intersections via a pivot.

19. The apparatus for ablation therapy of the digestive tract according to claim 1 or 9, characterized in that, Each linkage mechanism is an X-type linkage mechanism, and there are 4 to 10 linkage mechanisms.

20. The apparatus for ablation therapy of the digestive tract according to claim 1 or 9, characterized in that, One of the outer ends of the first link and the second link is slidably connected to the side rod, and the other outer end is rotatably connected to the side rod via a pivot.

21. The apparatus for ablation therapy of the digestive tract according to claim 20, characterized in that, The side rod is provided with a guide groove extending in the front-rear direction of the side rod, and one of the outer ends of the first connecting rod and the second connecting rod is slidably connected to the side rod through the guide groove.

22. The apparatus for ablation therapy of the digestive tract according to claim 1 or 9, characterized in that, The outer ends of the first link and the second link are slidably connected to the front and rear parts of the side link, respectively.

23. The apparatus for ablation therapy of the digestive tract according to claim 22, characterized in that, The front and rear portions of the side rod are respectively provided with a first arc-shaped guide groove and a second arc-shaped guide groove. The outer ends of the first connecting rod and the second connecting rod are slidably connected to the front and rear portions of the side rod through the first arc-shaped guide groove and the second arc-shaped guide groove, respectively. The first arc-shaped guide groove bends from back to front inward, and the second arc-shaped guide groove bends from back to front inward.

24. The apparatus for ablation therapy of the digestive tract according to claim 1 or 9, characterized in that, The side rod is formed by connecting at least two rods to create a telescopic rod with a variable length in the front-to-back direction. The outer ends of the first and second connecting rods are rotatably connected to the front and rear ends of the telescopic rod via pivots, respectively.

25. The apparatus for ablation therapy of the digestive tract according to claim 1 or 9, characterized in that, The inner end of the first link is rotatably connected to the rear connecting seat via a pivot, and the inner end of the second link is rotatably connected to the front connecting seat via a pivot.

26. The apparatus for ablation therapy of the digestive tract according to claim 1 or 9, characterized in that, The inner end of the first link is fixedly connected to the rear connecting seat, and / or the inner end of the second link is fixedly connected to the front connecting seat. When the support frame changes between the contracted working state and the expanded working state, the inner end of the first link and / or the inner end of the second link are allowed to deform and bend.

27. The apparatus for ablation therapy of the digestive tract according to claim 1 or 9, characterized in that, It also includes an operating handle connected to the rear of the inner guide rod and / or the rear of the outer tube, the operating handle being provided with an adjustment device for adjusting the relative rotation of the outer tube and the inner guide rod, or for adjusting the relative rotation of the inner guide rod relative to the outer tube.

28. The apparatus for ablation therapy of the digestive tract according to claim 1 or 9, characterized in that, When the supporting frame is in a contracted working state and / or an expanded working state, the side rods on each linkage mechanism are parallel to the front of the inner guide rod, and the side rods are arranged circumferentially around the axis of the inner guide rod.

29. The apparatus for ablation therapy of the digestive tract according to claim 1 or 9, characterized in that, When the support frame is in a contracted working state, the electrode array film is wound or / and folded onto the support frame.

30. The apparatus for ablation therapy of the digestive tract according to claim 29, characterized in that, The electrode array membrane is shaped like a spiral spring, possessing radially self-contracting elastic force. The electrode array membrane is wound around each of the side rods, with its inner end connected to one of the side rods and its outer end being a free end. During the transition from a contracted to an expanded working state of the support frame, the side rods expand the electrode array membrane outwards, causing the diameter of the outermost layer of the electrode array membrane on each side rod to gradually increase, and the total number of turns of the electrode array membrane to gradually decrease. Conversely, during the transition from an expanded to a contracted working state of the support frame, the self-contracting elastic force of the electrode array membrane causes the diameter of the outermost layer of the electrode array membrane to gradually decrease, and the total number of turns of the electrode array membrane to gradually increase.

31. The apparatus for ablation therapy of the digestive tract according to claim 30, characterized in that: The electrode array film is provided with shape memory alloy strips. When the supporting frame is in a contracted working state, the shape of the electrode array film is the memory shape of the shape memory alloy strips.

32. The apparatus for ablation therapy of the digestive tract according to claim 1 or 9, characterized in that, The length of the side rod in the front-to-back direction is approximately equal to the width of the electrode array film in the front-to-back direction, with a difference of less than 1.5 mm, preferably less than 0.5 mm or equal.

33. A system for ablation therapy of the digestive tract, characterized in that, It includes the apparatus for ablation treatment of the digestive tract as described in any one of claims 1-32, and it further includes: A signal generator configured to generate an electrical signal for treatment and electrically connected to electrodes.

34. A device for duodenal ablation therapy, characterized in that, It includes an apparatus for ablation treatment of the digestive tract as described in any one of claims 1-32.

35. Use of the device for duodenal ablation therapy as described in claim 34 in the treatment of diabetes.

36. Use of the device for duodenal ablation therapy as described in claim 34 in the treatment of obesity.

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