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] Inner guide rod;

[0006] An outer tube, which is fitted onto the inner guide rod;

[0007] An expandable component surrounds the inner guide rod and / or outer sleeve and is located near the front of the inner guide rod, wherein the expandable component includes:

[0008] 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. The outer ends of the first and second links are respectively connected to the side links. 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 connected to the inner guide rod and / or the outer sleeve. The rear connecting seat is connected to the inner guide rod and / or the outer sleeve. The outer sleeve is rotatably connected to the inner guide rod, or is movable only in the front-back direction, or is both movable in the front-back direction and rotatably connected. This allows the distance between the rear and front connecting seats to change, and the distance between the outer ends of the first and second links to also change accordingly. Thus, the support frame changes between the contracted and expanded 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, the first link and the second link are rotatably connected by a pivot at their intersection.

[0011] Preferably, each linkage mechanism is an X-type linkage mechanism, and the number of linkage mechanisms is 4-10.

[0012] 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.

[0013] 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.

[0014] 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.

[0015] 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, and 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.

[0016] Preferably, the first arc-shaped guide groove bends inward from back to front, and the second arc-shaped guide groove bends outward from back to front.

[0017] Preferably, the side rod is a telescopic rod formed by connecting at least two rods to form a telescopic rod with a variable length in the front-to-back direction, and the two outer ends of the first link and the second link are rotatably connected to the front end and the rear end of the telescopic rod respectively via a pivot.

[0018] 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.

[0019] Preferably, the outer sleeve is rotatable relative to the inner guide rod and is prohibited from moving in the front-to-back direction. A side guide rod parallel to the inner guide rod is fixedly connected to the side of the inner guide rod. The front connecting seat and / or the rear connecting seat are slidably connected to the side guide rod in the front-to-back direction, so that the front connecting seat and / or the rear connecting seat can only move in the front-to-back direction relative to the inner guide rod but is prohibited from rotating. The front connecting seat and / or the rear connecting seat are threadedly connected to the outer sleeve.

[0020] Preferably, the front connecting seat is connected to the outer sleeve via a first thread, and the rear connecting seat is connected to the outer sleeve via a second thread, wherein the first thread and the second thread have opposite thread directions.

[0021] Preferably, one of the front and rear connecting seats is threadedly connected to the outer sleeve, and the other connecting seat is movably connected to the outer sleeve and / or the inner guide rod in the front-to-back direction, and the outer sleeve and / or the inner guide rod are rotatably connected relative to the other connecting seat.

[0022] Preferably, the front connecting seat and / or the rear connecting seat are sleeved on the outer sleeve and / or the inner guide rod.

[0023] Preferably, the side guide rod includes a first side guide rod and a second side guide rod located on both sides of the inner guide rod and / or both sides of the outer tube.

[0024] Preferably, the front connecting seat is connected to the front part of the inner guide rod, and the rear connecting seat is connected to the front part of the outer tube.

[0025] Preferably, the outer tube can only move in the back-and-forth direction relative to the inner guide rod, or the inner guide rod can only move in the back-and-forth direction relative to the outer tube, the front connecting seat is fixedly connected to the front part of the inner guide rod, and the rear connecting seat is fixedly connected to the front part of the outer tube.

[0026] 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.

[0027] Preferably, the outer tube and the inner guide rod are connected by threads, so that the outer tube can move and rotate relative to the inner guide rod in both the forward and backward directions, or the inner guide rod can move and rotate relative to the outer tube in both the forward and backward directions.

[0028] Preferably, the front part of the outer sleeve is connected to the inner guide rod by a thread.

[0029] Preferably, one of the front and rear connecting seats is sleeved on the inner guide rod, allowing the inner guide rod to rotate within the connecting seat while prohibiting the connecting seat from moving relative to the inner guide rod in the front-to-back direction, and the other connecting seat is fixedly connected to the outer tube.

[0030] Preferably, the inner guide rod can move and rotate relative to the outer tube in both the front-back and rear-back directions. A side guide rod is fixedly connected to the side of the outer tube, and the side guide rod is parallel to the inner guide rod. The rear connecting seat is sleeved on the front of the outer tube, and the rear connecting seat and the side guide rod are slidably connected in the front-back direction. The front connecting seat is sleeved on the inner guide rod, and the side guide rod passes through the front connecting seat, so that the inner guide rod can rotate relative to the front connecting seat but is prohibited from moving in the front-back direction.

[0031] Preferably, the inner guide rod can move and rotate relative to the outer tube in both the front-back and rear-back directions. A side guide rod is fixedly connected to the side of the outer tube. The side guide rod is parallel to the inner guide rod. The front connecting seat is sleeved on the inner guide rod and threadedly connected to it. The rear connecting seat is sleeved on the front end of the outer tube. Both the front and rear connecting seats are slidably connected to the side guide rod in the front-back direction, so that the front and rear connecting seats can only move relative to each other in the front-back direction but are prohibited from rotating relative to each other.

[0032] Preferably, the side guide rod includes a first side guide rod and a second side guide rod located on both sides of the outer tube and / or the inner guide rod.

[0033] Preferably, the outer sleeve can move back and forth and rotate relative to the inner guide rod. One of the front and rear connecting seats is sleeved on the outer sleeve, so that the outer sleeve can rotate relative to the connecting seat but is prohibited from moving back and forth. The other connecting seat is fixedly connected to the inner guide rod.

[0034] Preferably, the connection structure between the front connecting seat and the inner guide rod has one or a combination of the following four forms: the front connecting seat and the inner guide rod are fixedly connected; the front connecting seat is slidable relative to the inner guide rod in the front-rear direction and is prohibited from rotating; the inner guide rod is rotatable in the front connecting seat and is prohibited from sliding in the front-rear direction; the inner guide rod and the front connecting seat are rotatably connected by a thread.

[0035] Preferably, the connection structure between the rear connector and the outer sleeve has one or a combination of the following four forms: the rear connector and the outer sleeve are fixedly connected; the rear connector is slidable relative to the outer sleeve in the front-back direction and is prohibited from rotating; the outer sleeve is rotatable within the rear connector and is prohibited from sliding in the front-back direction; the outer sleeve and the rear connector are rotatably connected by threads.

[0036] Preferably, it further includes an operating handle, on which an adjusting device is provided or connected, the adjusting device being used to adjust the relative position of the outer sleeve and the inner guide rod, so that the outer sleeve can move or / and rotate relative to the inner guide rod in the front-back direction, or so that the inner guide rod can move or / and rotate relative to the outer sleeve in the front-back direction.

[0037] 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.

[0038] Preferably, when the support frame is in a retracted working state, the electrode array film is wound or / and folded onto the support frame.

[0039] 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 the side rod 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.

[0040] 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.

[0041] Preferably, 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 the retracted working state, the front guide cap and the rear guide cap respectively cover the front end and the rear end of the support frame. The front guide cap and the rear guide cap have an outer surface that is approximately conical. 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.

[0042] Preferably, 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, and preferably less than 0.5 mm or equal.

[0043] A system for ablation therapy of the digestive tract, the aforementioned apparatus for ablation therapy of the digestive tract, further includes:

[0044] A signal generator configured to generate an electrical signal for treatment and electrically connected to electrodes.

[0045] An apparatus for duodenal ablation therapy, comprising the aforementioned apparatus for ablation therapy of the digestive tract.

[0046] The use of a device for duodenal ablation therapy in the treatment of diabetes.

[0047] The use of a device for duodenal ablation therapy in the treatment of obesity. Attached Figure Description

[0048] 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;

[0049] 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;

[0050] Appendix Figure 3 The 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.

[0051] 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;

[0052] 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.

[0053] Appendix Figure 6 for Figure 4 The front view of this linkage mechanism shows the support frame in a retracted working state.

[0054] 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;

[0055] 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;

[0056] 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.

[0057] Appendix Figure 10 for Figure 9 The front view of the supporting frame when it is in the retracted working state;

[0058] 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.

[0059] Appendix Figure 12 for Figure 11 The front view of the supporting frame when it is in the retracted working state;

[0060] 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;

[0061] 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;

[0062] 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;

[0063] 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.

[0064] Appendix Figure 17To 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 tube. At this time, the support frame is in a fully expanded working state.

[0065] Appendix Figure 18 for Figure 17 The main sectional view of the supporting skeleton in an incompletely expanded working state;

[0066] 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 tube. At this time, the support frame is in a fully expanded working state.

[0067] Appendix Figure 20 for Figure 19 The main sectional view of the supporting skeleton in an incompletely expanded working state;

[0068] 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 tube. At this time, the support frame is in a fully expanded working state.

[0069] Appendix Figure 22 for Figure 21 The main sectional view of the supporting skeleton in an incompletely expanded working state;

[0070] 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 tube. At this time, the support frame is in a fully expanded working state.

[0071] Appendix Figure 24 for Figure 23 The main sectional view of the supporting skeleton in an incompletely expanded working state;

[0072] Appendix Figure 25 The 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.

[0073] Appendix Figure 26 for Figure 25 BB direction sectional view;

[0074] Appendix Figure 27 for Figure 25 A sectional view along the AA direction;

[0075] Appendix Figure 28The 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.

[0076] 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.

[0077] 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. Guide groove; 22. First thread; 23. Second thread; 24. Slider; 25. Stress relief tube; 26. First side guide rod; 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. Slider guide; Detailed Implementation

[0078] 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.

[0079] Referring to the accompanying drawings, an apparatus for ablation therapy of the digestive tract includes:

[0080] Inner guide rod 1;

[0081] Outer tube 2, which is sleeved on the inner guide rod 1;

[0082] 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:

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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 11 As 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.

[0088] 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.

[0089] See appendix Figure 2 Appendix Figure 4 To be continued Figure 12 and attached Figure 17 To be continued Figure 24The 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.

[0090] 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.

[0091] See appendix Figure 25 To be continued Figure 27A 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.

[0092] 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.

[0093] See appendix Figure 3Alternatively, 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.

[0094] 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.

[0095] 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.

[0096] 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.

[0097] 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.

[0098] 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.

[0099] 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.

[0100] 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.

[0101] 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.

[0102] 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.

[0103] 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.

[0104] 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.

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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.

[0109] 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.

[0110] 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.

[0111] 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.

[0112] 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.

[0113] 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.

[0114] 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: Inner guide rod; An outer tube, which is fitted onto the inner guide rod; An expandable component surrounds the inner guide rod and / or outer sleeve and is located near the front of the inner guide rod, wherein the expandable component includes: 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. The outer ends of the first and second links are respectively connected to the side links. 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 connected to the inner guide rod and / or the outer sleeve. The rear connecting seat is connected to the inner guide rod and / or the outer sleeve. The outer sleeve is rotatably connected to the inner guide rod, or is movable only in the front-back direction, or is both movable in the front-back direction and rotatably connected. This allows the distance between the rear and front connecting seats to change, and the distance between the outer ends of the first and second links to also change accordingly. Thus, the support frame changes 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.

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

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

4. The apparatus for ablation therapy of the digestive tract according to claim 1, 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.

5. The apparatus for ablation therapy of the digestive tract according to claim 4, 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.

6. The apparatus for ablation therapy of the digestive tract according to claim 1, 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.

7. The apparatus for ablation therapy of the digestive tract according to claim 6, 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.

8. The apparatus for ablation therapy of the digestive tract according to claim 1, 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.

9. The apparatus for ablation therapy of the digestive tract according to claim 1, 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.

10. The apparatus for ablation therapy of the digestive tract according to claim 1, characterized in that, The outer sleeve is connected to the inner guide rod in a way that allows only rotation and prohibits movement in the front-to-back direction. A side guide rod parallel to the inner guide rod is fixedly connected to the side of the inner guide rod. The front connecting seat and / or the rear connecting seat are slidably connected to the side guide rod in the front-to-back direction, so that the front connecting seat and / or the rear connecting seat can only move in the front-to-back direction relative to the inner guide rod but is prohibited from rotating. The front connecting seat and / or the rear connecting seat are threadedly connected to the outer sleeve.

11. The apparatus for ablation therapy of the digestive tract according to claim 10, characterized in that, The front connector is connected to the outer sleeve via a first thread, and the rear connector is connected to the outer sleeve via a second thread, wherein the first thread and the second thread have opposite thread directions.

12. The apparatus for ablation therapy of the digestive tract according to claim 10, characterized in that, One of the front and rear connecting seats is threadedly connected to the outer sleeve, and the other connecting seat is movably connected to the outer sleeve and / or the inner guide rod in the front-to-back direction, and the outer sleeve and / or the inner guide rod are rotatably connected relative to the other connecting seat.

13. The apparatus for ablation therapy of the digestive tract according to claim 1, characterized in that, The front connecting seat and / or the rear connecting seat are sleeved on the outer sleeve and / or the inner guide rod.

14. The apparatus for ablation therapy of the digestive tract according to claim 10, characterized in that, The side guide rods include a first side guide rod and a second side guide rod located on both sides of the inner guide rod and / or both sides of the outer tube.

15. The apparatus for ablation therapy of the digestive tract according to claim 1, characterized in that, The outer tube can only move in the back-and-forth direction relative to the inner guide rod, or the inner guide rod can only move in the back-and-forth direction relative to the outer tube. The front connecting seat is fixedly connected to the front part of the inner guide rod, and the rear connecting seat is fixedly connected to the front part of the outer tube.

16. The apparatus for ablation therapy of the digestive tract according to claim 1, 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.

17. The apparatus for ablation therapy of the digestive tract according to claim 1, characterized in that, The outer tube and the inner guide rod are connected by threads, so that the outer tube can move and rotate relative to the inner guide rod in both the forward and backward directions, or the inner guide rod can move and rotate relative to the outer tube in both the forward and backward directions.

18. The apparatus for ablation therapy of the digestive tract according to claim 17, characterized in that, The front part of the outer tube is connected to the inner guide rod by a thread.

19. The apparatus for ablation therapy of the digestive tract according to claim 18, characterized in that, One of the front and rear connecting seats is sleeved on the inner guide rod, allowing the inner guide rod to rotate within the connecting seat while prohibiting the connecting seat from moving relative to the inner guide rod in the front-back direction. The other connecting seat is fixedly connected to the outer tube.

20. The apparatus for ablation therapy of the digestive tract according to claim 18, characterized in that, The inner guide rod can move back and forth and rotate relative to the outer tube. A side guide rod is fixedly connected to the side of the outer tube. The side guide rod is parallel to the inner guide rod. The rear connecting seat is sleeved on the front of the outer tube. The rear connecting seat and the side guide rod are slidably connected in the back and forth direction. The front connecting seat is sleeved on the inner guide rod. The side guide rod passes through the front connecting seat, so that the inner guide rod can rotate relative to the front connecting seat but is prohibited from moving back and forth.

21. The apparatus for ablation therapy of the digestive tract according to claim 18, characterized in that, The inner guide rod can move and rotate relative to the outer tube in both the front-back and rear-back directions. A side guide rod is fixedly connected to the side of the outer tube. The side guide rod is parallel to the inner guide rod. The front connecting seat is sleeved on the inner guide rod and threadedly connected to it. The rear connecting seat is sleeved on the front end of the outer tube. Both the front and rear connecting seats are slidably connected to the side guide rod in the front-back direction, so that the front and rear connecting seats can only move relative to each other in the front-back direction but are prohibited from rotating relative to each other.

22. The apparatus for ablation therapy of the digestive tract according to claim 10, 20, or 21, characterized in that, The side guide rods include a first side guide rod and a second side guide rod located on both sides of the outer tube and / or the inner guide rod.

23. The apparatus for ablation therapy of the digestive tract according to claim 18, characterized in that, The outer tube can move back and forth and rotate relative to the inner guide rod. One of the front and rear connecting seats is sleeved on the outer tube, so that the outer tube can rotate relative to the connecting seat but is prohibited from moving back and forth. The other connecting seat is fixedly connected to the inner guide rod.

24. The apparatus for ablation therapy of the digestive tract according to claim 1, characterized in that, The connection structure between the front connecting seat and the inner guide rod has one of the following four forms or a combination thereof: the front connecting seat and the inner guide rod are fixedly connected; the front connecting seat is slidable relative to the inner guide rod in the front-back direction and is prohibited from rotating; the inner guide rod is rotatable in the front connecting seat and is prohibited from sliding in the front-back direction; the inner guide rod and the front connecting seat are rotatably connected by a thread.

25. The apparatus for ablation therapy of the digestive tract according to claim 1, characterized in that, The connection structure between the rear connector and the outer sleeve has one or a combination of the following four forms: the rear connector and the outer sleeve are fixedly connected; the rear connector is slidable relative to the outer sleeve in the front-back direction and is prohibited from rotating; the outer sleeve is rotatable within the rear connector and is prohibited from sliding in the front-back direction; the outer sleeve and the rear connector are rotatably connected by threads.

26. The apparatus for ablation therapy of the digestive tract according to claim 1, characterized in that, It also includes an operating handle, on which an adjustment device is provided or connected, the adjustment device being used to adjust the relative position of the outer tube and the inner guide rod, so that the outer tube can move or / and rotate relative to the inner guide rod in the front-back direction, or so that the inner guide rod can move or / and rotate relative to the outer tube in the front-back direction.

27. The apparatus for ablation therapy of the digestive tract according to claim 1, 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.

28. The apparatus for ablation therapy of the digestive tract according to claim 1, 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.

29. The apparatus for ablation therapy of the digestive tract according to claim 28, 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.

30. The apparatus for ablation therapy of the digestive tract according to claim 29, 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.

31. 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 the retracted working state, the front guide cap and the rear guide cap cover the front end and the rear end of the support frame, respectively. The front guide cap and the rear guide cap have an outer surface that is approximately conical. 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.

32. The apparatus for ablation therapy of the digestive tract according to claim 1, 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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