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

Abstract

The application relates to a device for ablation treatment of human digestive tract, which comprises an inner guide rod, an outer sleeve, and an expandable component, wherein the expandable component comprises a support framework and an electrode array film arranged on the support framework, the support framework comprises an inner support framework and a plurality of outer support rods, each outer support rod is fixedly connected to a middle support rod, and the length of the outer support rod in the front-rear direction is greater than the length of the middle support rod in the front-rear direction; the device can accurately perform electric field treatment on the inner wall of the upper digestive tract, especially 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.

[0003] CN118845203A discloses an ablation device and apparatus. In Figure 25, the expansion member includes a compressible stent, with at least a portion of the ablation structure surrounding the compressible stent. The ablation structure is unfolded or rolled up by manipulating the stent at its distal end to stretch or compress it. For ease of understanding, the working principle of this stent can be compared to the opening and closing mechanism of an umbrella. The compressible stent of this apparatus can effectively support the ablation structure during the ablation procedure, overcoming the defect of CN114786605A, which deforms under pressure. However, in the contracted state, the length of the compressible stent in the anterior-posterior direction is much greater than the width of the ablation structure in the anterior-posterior direction, and the compressible stent is a long, rigid component in the contracted state. This compressible stent is difficult to penetrate deep into the duodenum and other parts of the curved human digestive tract, and even if it does, it can easily damage the inner wall of the digestive tract. Summary of the Invention

[0004] The purpose of this invention is to provide an apparatus, system and application for ablation therapy of the human digestive tract. The expandable component of the apparatus has better rigidity after expansion and its length in the front-to-back direction is greatly shortened when it contracts.

[0005] The technical solution of this invention is:

[0006] A device for ablation therapy of the human digestive tract, comprising:

[0007] Slender inner guide rod;

[0008] A slender outer sleeve is slidably fitted onto the inner guide rod along the length of the inner guide rod;

[0009] An expandable component surrounds the inner guide rod and is located near the front portion of the inner guide rod, wherein the expandable component includes:

[0010] A support frame is provided, which has a contracted working state and an expanded working state. The support frame includes an inner support frame and multiple outer support rods. The inner support frame includes a front support frame, a middle support frame, and a rear support frame connected in sequence. The front end of the front support frame is connected to the front of the inner guide rod, and the rear end of the rear support frame is connected to the front of the outer sleeve. In the expanded working state, the front support frame gradually moves away from the inner guide rod from front to back, and the rear support frame gradually moves away from the inner guide rod from back to front. The middle support frame has multiple middle support rods parallel to the inner guide rod and distributed in a circumferential direction, with each middle support rod maintaining the same distance from the inner guide rod. Each outer support rod is fixedly connected to each middle support rod. Each outer support rod has a front extension section extending forward of the middle support rod, and / or a rear extension section extending backward of the middle support rod, such that the length of the outer support rod in the front-back direction is greater than the length of the middle support rod in the front-back direction.

[0011] A flexible electrode array membrane is provided, wherein the electrode array membrane is provided with multiple electrodes coupled to a signal generator for generating electric field energy. The electrode array membrane is disposed on the outer support rod. When the support frame is in an expanded working state, the outer support rod supports the electrode array membrane outward. When the support frame is in a contracted working state, the electrode array membrane is rolled up or / and folded on the outer support rod.

[0012] Furthermore, the front support frame includes multiple front support rods, the front ends of which are fixedly connected to the front of the inner guide rod; the rear support frame includes multiple rear support rods, the rear ends of which are fixedly connected to the front of the outer sleeve; the front ends of each middle support rod are respectively connected to the rear ends of each front support rod, and the rear ends of each middle support rod are respectively connected to the front ends of each rear support rod; the outer support rods are circumferentially distributed around the inner guide rod, and the outer support rods are parallel to the inner guide rod.

[0013] Furthermore, the rear end of the front support rod is connected to the front end of the middle support rod to form a front connecting part, and the front end of the rear support rod is also connected to the rear end of the middle support rod to form a rear connecting part. When the support frame is in an expanded working state, the front connecting part is in a bent state, and the rear connecting part is also in a bent state.

[0014] Furthermore, the inner support frame is made of shape memory alloy material, and the shape of the support frame in the expanded working state is the memory shape of the inner support frame.

[0015] Furthermore, when the support frame is in the expanded working state, the multiple front support rods are arranged radially backward with the connection point with the inner guide rod as the center; the multiple rear support rods are arranged radially forward with the connection point with the outer sleeve as the center.

[0016] Furthermore, 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 outer support rods, with its inner end fixedly connected to the support frame and its outer end being a free end. During the transition from a contracted to an expanded working state, the outer support rods support the electrode array membrane outwards, causing the diameter of the outermost layer of the electrode array membrane to gradually increase and the total number of turns to gradually decrease. Conversely, during the transition from an expanded to a contracted working state, the self-contracting elastic force of the electrode array membrane causes its diameter to gradually decrease and the total number of turns to gradually increase.

[0017] Furthermore, the width of the electrode array film in the front-to-back direction is greater than or equal to the length of the outer support rod in the front-to-back direction, and the length difference between the two is less than or equal to 2 mm.

[0018] Furthermore, the length of the outer support rod in the front-to-back direction is greater than the length of the middle support frame in the front-to-back direction.

[0019] Furthermore, the length of the outer support rod in the front-to-back direction is 1.5 to 10 times the length of the middle support frame in the front-to-back direction.

[0020] Furthermore, the number of external support rods is 5-12.

[0021] Furthermore, when the support frame is in an expanded working state, the length of the outer support rod in the front-to-back direction is greater than the length of the inner support frame in the front-to-back direction.

[0022] Furthermore, it also includes an operating handle disposed at the rear of the outer tube and / or the inner guide rod, wherein the operating handle is provided with a position adjustment device for adjusting the inner guide rod to slide relative to the outer tube in the front-back direction, or the operating handle is provided with a position adjustment device for adjusting the outer tube to slide relative to the inner guide rod in the front-back direction.

[0023] A system for ablation therapy of the human digestive tract, comprising the aforementioned apparatus for ablation therapy of the human digestive tract, and further comprising:

[0024] A signal generator configured to generate an electrical signal that generates electric field energy;

[0025] An apparatus for ablation treatment of the human duodenum, comprising the aforementioned apparatus for ablation treatment of the human digestive tract.

[0026] The use of a device for ablation treatment of the human duodenum, as described above, in the treatment of diabetes.

[0027] The use of a device for ablation treatment of the human duodenum, as described above, in the treatment of obesity.

[0028] Compared with the prior art, the present invention has the following advantages:

[0029] In its expanded state, the supporting framework is supported by the outer support rods, ensuring that the electrode array membrane remains roughly cylindrical even when compressed by the body cavity during digestive tract ablation surgery. This allows for precise ablation of the body cavity. Since the electrode array membrane is supported by the outer support rods, the length of the middle support rod in the front-back direction can be less than that of the outer support rod. With the electrode array membrane having the same width in the front-back direction, when the supporting framework is in its contracted state, the inner supporting framework is shortened in the front-back direction. This reduces the length of the expandable component in the front-back direction during contraction, facilitating the device's entry and exit through the curved digestive tract during ablation surgery. Attached Figure Description

[0030] Appendix Figure 1 A front view of a system for ablation therapy of the human digestive tract, with its supporting framework in a contracted working state;

[0031] Appendix Figure 2 This is a three-dimensional structural diagram of a device for ablation therapy of the human digestive tract, with its supporting frame in an expanded working state.

[0032] Appendix Figure 3 The front view of the device for ablation therapy of the human digestive tract is omitted after the electrode array membrane is cut off, and its supporting frame is in a contracted working state.

[0033] Appendix Figure 4 For the appendix Figure 3 A sectional view along the AA direction;

[0034] Appendix Figure 5The front view of the device for ablation therapy of the human digestive tract is omitted after the electrode array membrane is cut off, and its supporting frame is in an expanded working state.

[0035] Appendix Figure 6 For the appendix Figure 5 BB direction sectional view;

[0036] Appendix Figure 7 This is a three-dimensional structural diagram of a device for ablation therapy of the human digestive tract when using a different support skeleton structure. The support skeleton is in an expanded working state. The electrode array membrane is omitted in this diagram.

[0037] Appendix Figure 8 For the appendix Figure 1 The operating handle in the CC direction cross-sectional view shows the structure of a position adjustment device. By rotating the first knob in both directions, the outer tube can be driven to move relative to the inner guide rod in the front-back direction.

[0038] Appendix Figure 9 For the appendix Figure 1 DD-direction sectional view;

[0039] Appendix Figure 10 This is a cross-sectional view of the internal structure of another type of operating handle, showing the structure of another position adjustment device. By rotating the second knob in both directions, the inner guide rod can be driven to move relative to the outer sleeve in the front-back direction.

[0040] Appendix Figure 11 This is a three-dimensional structural diagram of a device for ablation therapy of the human digestive tract when using the third type of support skeleton structure. The support skeleton is in an expanded working state. The electrode array membrane is omitted in this diagram.

[0041] Appendix Figure 12 The outer support rods are omitted for the third type of support frame; only the three-dimensional structural diagram of the inner support frame is shown.

[0042] Appendix Figure 13 for Figure 2 The top view of an embodiment in which the electrode array film is wound and folded onto each of the outer support rods when the support frame is in the retracted working state (the support frame is not fully retracted for clarity of the structure);

[0043] Appendix Figure 14 for Figure 2 The top view of another embodiment of the support frame folded between the outer support rods when the support frame is in the retracted working state (the support frame is not fully retracted for clarity of the structure);

[0044] Appendix Figure 15 for Figure 2The top view of the third embodiment, in which the electrode array film is wound around the outer support rod when the support frame is in the retracted working state (the support frame is not fully retracted for the sake of clear expression of the structure);

[0045] The components are as follows: 1. Inner guide rod; 2. Outer sleeve; 3. Expandable component; 4. Support frame; 5. Inner support frame; 7. Front support frame; 8. Middle support frame; 9. Rear support frame; 10. Electrode array membrane; 11. Signal generator; 12. Electrode; 13. Front support rod; 14. Rear support rod; 15. Middle support rod; 16. Outer support rod; 17. Front connecting part; 18. Rear connecting part; 19. Operating handle; 21. Front guide cap; 22. Rear guide cap; 23. Guide wire hole; 24. Auxiliary support rod; 25. Position adjustment device; 26. First knob; 27. Slider; 28. Slider guide; 29. ​​Second knob; 30. Gear; 31. Rack; 32. Knob pivot; 33. Front connecting ring; 34. Rear connecting ring; 35. Front extension section; 36. Rear extension section. Detailed Implementation

[0046] 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.

[0047] Referring to the accompanying drawings, a device for ablation therapy of the human digestive tract includes:

[0048] A slender inner guide rod 1, wherein a guide wire hole 23 is opened in the center of the inner guide rod 1 for inserting and passing the guide wire hole 23;

[0049] The slender outer tube 2 is slidably fitted onto the inner guide rod 1 along its length. In the accompanying drawings, the outer tube 2 consists of two layers, inner and outer, which are fixedly connected. Multiple wires pass through the interlayer between the two outer tubes 2. These wires are used to electrically connect the electrode 12 and the signal generator 11. In addition, the wires are also used to transmit sensing signals, such as temperature signals and pressure signals, emitted by the sensor mounted on the expandable component 3.

[0050] Expandable component 3 surrounds the inner guide rod 1 and is located near the front of the inner guide rod 1, wherein the expandable component 3 includes:

[0051] A support frame 4 has a retracted working state and an expanded working state. The support frame 4 includes an inner support frame 5 and multiple outer support rods 16. The inner support frame 5 includes a front support frame 7, a middle support frame 8, and a rear support frame 9 connected in sequence. The front end of the front support frame 7 is connected to the front of the inner guide rod 1, and the rear end of the rear support frame 9 is connected to the front of the outer sleeve 2. When the support frame 4 is in the expanded working state, the front support frame 7 gradually moves away from the inner guide rod 1 from front to back, and the rear support frame 9 gradually moves away from the inner guide rod 1 from back to front. The middle support frame 8 maintains a substantially equal distance from the inner guide rod 1 from back to front. The middle support frame 8 has multiple middle support rods 15 that are parallel to the inner guide rod 1 and distributed along the circumferential direction. Each outer support rod 16 is fixedly connected to each middle support rod 15. The outer support rod 16 has a front extension section 35 extending forward of the middle support rod 15, or / and the outer support rod 16 has a rear extension section 36 extending backward of the middle support rod 15, such that the length of the outer support rod 16 in the front-back direction is greater than the length of the middle support rod 15 in the front-back direction.

[0052] A flexible electrode array membrane 10 is provided with multiple electrodes 12 coupled to a signal generator 11 for generating electric field energy. The electrode array membrane 10 is disposed on the outer support rod 16. When the support frame 4 is in an expanded working state, the outer support rod 16 supports the electrode array membrane 10 outward. When the support frame 4 is in a contracted working state, the electrode array membrane 10 is rolled up or / and folded on the outer support rod 16.

[0053] Appendix Figure 1 -Appendix Figure 6This is an embodiment of an inner support frame 5. In this embodiment, the front support frame 7 includes multiple front support rods 13, the front ends of each front support rod 13 being fixedly connected to a front connecting ring 33. The front connecting ring 33 is fixedly connected to the front part of the inner guide rod 1, and can be considered as part of the inner guide rod 1. The rear support frame 9 includes multiple rear support rods 14, the rear ends of each rear support rod 14 being fixedly connected to a rear connecting ring 34. The rear connecting ring 34 is fixedly connected to the front part of the outer sleeve 2, and can be considered as part of the outer sleeve 2. The front ends of each middle section support rod 15 are connected to the rear ends of each front section support rod 13, and the rear ends of each middle section support rod 15 are connected to the front ends of each rear section support rod 14. The outer support rods 16 are distributed circumferentially around the inner guide rod 1, and the outer support rods 16 are parallel to the inner guide rod 1. The outer support rods 16 are fixedly connected to the middle section support rods 15. The length of the outer support rods 16 in the front-back direction is much greater than the length of the middle section support rods 15 in the front-back direction, ranging from 1.5 times to 10 times, or even 15 times.

[0054] As attached Figure 5 and attached Figure 6 As shown, the rear end of the front support rod 13 is connected to the front end of the middle support rod 15 to form a front connecting part 17, and the front end of the rear support rod 14 is also connected to the rear end of the middle support rod 15 to form a rear connecting part 18. When the support frame 4 is in the expanded working state, the front connecting part 17 is bent, and the rear connecting part 18 is also bent. The inner support frame 5 is made of a shape memory alloy material of nickel-titanium, and the shape of the support frame 4 in the expanded working state is the memory shape of the inner support frame 5.

[0055] As attached Figure 1 As shown, with the supporting frame 4 in its retracted working state, the device for ablation treatment of the human digestive tract is slowly passed through the esophagus, stomach, or duodenum from the mouth, and the attachment is rotated. Figure 8 Or attached Figure 10 The first knob 26 or the second knob 29 on the operating handle 19 shown shortens the distance between the front of the inner guide rod 1 and the front of the outer guide rod 2, and under the force of the shape memory alloy material, the supporting frame 4 is attached... Figure 1 The contraction working state shown is towards the attached Figure 2 Appendix Figure 5 Appendix Figure 6 The expansion working state transition shown indicates that the electrode array film 10 expands into an attached... Figure 2The cylindrical shape shown can be attached to the inner wall of the upper digestive tract, such as the duodenum. This allows for ablation procedures to be performed on the upper digestive tract, particularly the duodenum. After the procedure, the attachment is rotated in the opposite direction. Figure 8 Or attached Figure 10 The first knob 26 or the second knob 29 on the operating handle 19 shown increases the distance between the front part of the inner guide rod 1 and the front part of the outer guide rod 2, causing the support frame 4 to retract into a retracted working state, and the electrode array film 10 to retract onto the outer support rod 16, as shown in the attached diagram. Figure 13 Appendix Figure 14 Appendix Figure 15 As shown, the device can then be removed from the upper digestive tract.

[0056] As attached Figure 5 and attached Figure 6 Appendix Figure 7 and appendix Figure 11 As shown, when the support frame 4 is in the expanded working state, the multiple front support rods 13 are arranged radially backward with their connection points with the inner guide rod 1 as the center; the multiple rear support rods 14 are arranged radially forward with their connection points with the outer sleeve 2 as the center; and the middle support rods 15 are distributed circumferentially along the inner guide rod 1, with each middle support rod 15 maintaining a substantially equal distance from the inner guide rod 1. (See attached diagram) Figure 3 Appendix Figure 4 As shown, when the support frame 4 is in the retracted working state, the inner support frame 5 is as close as possible to the inner guide rod 1.

[0057] Appendix Figure 7 This is an embodiment of the second inner support frame 5. In this embodiment, the front end of the front support rod 13 is pivotally connected to the front connecting ring 33, which is fixedly connected to the front of the inner guide rod 1. The front connecting ring 33 can be considered as part of the inner guide rod 1. The rear end of the rear support rod 14 is fixedly connected to the rear connecting ring 34, which is fixedly connected to the front of the outer sleeve 2. The rear connecting ring 34 can also be considered as part of the outer sleeve 2. The front and rear ends of the middle support rod 15 are pivotally connected to the rear end of the front support rod 13 and the front end of the rear support rod 14, respectively. An auxiliary support rod 24 is provided between the rear end of the middle support rod 15 and the inner guide rod 1. This auxiliary support rod 24 belongs to the inner support frame 5. The auxiliary support rod 24 is parallel to the front support rod 13, and its two ends are pivotally connected to the inner guide rod 1 and the rear end of the middle support rod 15, respectively. The auxiliary support rod 24 ensures that the inner support frame 5 maintains a unique movement trajectory (when the support frame 4 changes between the contracted working state and the expanded working state). The outer support rod 16 is fixedly connected to the middle support rod 15.

[0058] Appendix Figure 11 and appendix Figure 12 This is an embodiment of the third inner support frame 5. In this embodiment, the middle support frame 8 is mesh-like (the front support frame 7 and the rear support frame 9 can also be mesh-like). The middle support frame 8 has multiple middle support rods 15, and each outer support rod 16 is fixedly connected to the middle support rod 15. The front support frame 7 includes multiple front support rods 13, the front end of each front support rod 13 is fixedly connected to a front connecting ring 33, and the front connecting ring 33 is fixedly connected to the front of the inner guide rod 1. The rear support frame 9 includes multiple rear support rods 14, the rear end of each rear support rod 14 is fixedly connected to a rear connecting ring 34, and the rear connecting ring 34 is fixedly connected to the front of the outer sleeve 2.

[0059] Referring to the accompanying drawings, when the support frame 4 is in a contracted or expanded working state, each outer support rod 16 is parallel to the front of the inner guide rod 1. The outer support rods 16 are arranged circumferentially around the axis of the inner guide rod 1. In particular, when the support frame 4 is in an expanded working state, each outer support rod 16 supports the electrode array film 10 so that the outer surface of the electrode array film 10 is as cylindrical as possible (see attached drawings). Figure 2 The electrode array membrane 10 is wound and / or folded onto the outer support rod 16 when the support frame 4 is in the contracted working state (see Appendix). Figure 13 Appendix Figure 14 Appendix Figure 15 The substrate of the electrode array film 10 is a commonly used flexible polymer insulating film, such as polyimide or PET material. Various electrode array films 10 and connection methods with the support frame 4 can be selected. When the support frame 4 is in the contracted working state, the electrode array film 10 has a folded and rolled structure (as shown in the attached figure). Figure 13 (as shown); or the electrode array film 10 has a folded structure (as shown in the attached image). Figure 14 (as shown); or the electrode array film 10 has a wound structure (as shown in the attached image). Figure 15 As shown, the connection relationship between the electrode array film 10 and the outer support rod 16, as well as the state of the electrode array film 10 when it contracts, are only some of the listed embodiments.

[0060] See appendix Figure 15The electrode array membrane 10 is shaped like a spiral spring and has a radially self-contracting elastic force. The electrode array membrane 10 is wound around each of the outer support rods 16. The inner end of the electrode array membrane is fixedly connected to one of the outer support rods 16, and the outer end 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 outer support rods 16 expands the electrode array membrane 10 outwards, causing the diameter of the outermost layer of the electrode array membrane 10 on each outer support rod 16 to gradually increase, and the total number of turns of the electrode array membrane 10 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 10 gradually decreases due to the self-contracting elastic force of the electrode array membrane 10, and the total number of turns of the electrode array membrane 10 gradually increases. To enable the electrode array membrane 10 to have a self-contracting elastic force, the electrode array membrane 10 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 electrode array film 10 described herein has a shape that is a shape memory alloy strip.

[0061] See appendix Figure 1 -Appendix Figure 6 The inner guide rod 1 has a front guide cap 21 made of silicone material connected to its front end, and the outer tube 2 has a rear guide cap 22 made of silicone material connected to its front end. The soft front and rear guide caps 21 and 22 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 21 and 22 respectively cover the front and rear ends of the support frame 4. The front and rear guide caps 21 and 22 have approximately conical outer surfaces. The outer diameter of the conical outer surface of the front guide cap 21 gradually decreases from back to front, while the outer diameter of the conical outer surface of the rear guide cap 22 gradually decreases from front to back.

[0062] As attached Figure 2As shown, the length of the outer support rod 16 in the front-back direction is approximately equal to the width of the electrode array membrane 10 in the front-back direction. More preferably, the width of the electrode array membrane 10 in the front-back direction is greater than or equal to the length of the outer support rod 16 in the front-back direction, and the length difference between the two is less than or equal to 2 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 or nickel-titanium shape memory alloy, 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 to move forward or backward in the curved digestive tract, and the less likely it is to damage the inner wall tissue of the digestive tract. The outer sleeve 2 and the inner guide rod 1 are radially elastic because they are slender, and can bend appropriately with the curvature of the digestive tract. Assuming the electrode array film 10 has the same width along the front-to-back direction, this invention allows the middle support frame 8 to be shortened as much as possible (in the front-to-back length direction). For example, the length of the outer support rod 16 in the front-to-back direction is 1.5 to 10 times, or even 15 times, the length of the middle support frame 8 in the front-to-back direction. When the support frame 4 is in the expanded working state, the length of the outer support rod 16 in the front-to-back direction is greater than the length of the inner support frame 5 in the front-to-back direction, and there are 5-12 outer support rods. Therefore, the entire inner support frame 5 is also shorter in the front-to-back direction when in the contracted working state, which is one of the advantages of this invention. Furthermore, the structure of this invention is relatively simple, and therefore relatively easy to manufacture.

[0063] As attached Figure 1 As shown, the aforementioned device for ablation therapy of the human 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 11 located proximally to the operator. The signal generator 11 is configured to generate an electrical signal for treatment and is electrically connected to the electrode 12. The aforementioned device for ablation therapy of the human digestive tract is more suitable for ablation therapy of the duodenum.

[0064] As attached Figure 1 As shown, this device also includes an operating handle 19 disposed at the rear of the outer tube 2 and / or the inner guide rod 1. The operating handle 19 is provided with a position adjustment device 25 for adjusting the position of the inner guide rod 1 relative to the outer tube 2 in the front-back direction (e.g., ...). Figure 10 (as shown), or the operating handle 19 is provided with a position adjustment device 25 for adjusting the position of the outer tube 2 relative to the inner guide rod 1 in the front-back direction (e.g. Figure 8 and Figure 9 (As shown).

[0065] See appendix Figure 8 and attached Figure 9A first knob 26 is rotatably connected to the middle of the operating handle 19, but cannot move forward or backward (limited by the operating handle 19). A slider 27, movable relative to the operating handle 19 in the forward-backward direction, is disposed within the inner cavity of the first knob 26. The slider 27 is slidably connected to a slider guide 28 extending in the forward-backward direction and fixed to the operating handle 19. An outer sleeve 2 is fixedly connected to the slider 27. The outer surface of the slider 27 is also threaded, and the inner surface of the first knob 26 is also threaded to mate with the thread of the slider 27, 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 19. When the operating handle 19 is gripped and the first knob 26 is rotated in both directions, the first knob 26 drives the slider 27 to move forward or backward but not rotate via the thread, thereby causing the outer sleeve 2 fixed to the slider 27 to move only in the forward-backward direction 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. The position adjustment device 25 controls the outer tube 2 to move relative to the inner guide rod 1 in the front-back direction, thereby driving the support frame 4 to switch between the expansion working state and the contraction working state.

[0066] Reference Appendix Figure 10 Alternatively, the position adjustment device 25 can control the inner guide rod 1 to move relative to the outer guide tube 2 in the front-back direction. The rear part of the outer tube 2 is fixedly connected to the operating handle 19. A rack 31 is provided in the inner cavity of the operating handle 19, and the rack 31 is fixedly connected to the inner guide rod 1. A second knob 29 is also rotatably connected to the operating handle 19 through a knob pivot 32. A gear 30 coaxial with the knob pivot 32 is fixed on the second knob 29, and the gear 30 meshes with the rack 31. When the second knob 29 is rotated in both directions, the gear 30 drives the rack 31 to move relative to the operating handle 19 in the front-back direction, thereby driving the inner guide rod 1, which is fixedly connected to the rack 31, to move relative to the outer tube 2 in the front-back direction.

[0067] As attached Figure 1 As shown, a system for ablation therapy of the human upper digestive tract includes the above-mentioned device for ablation therapy of the human digestive tract, and further includes: a signal generator 11, which is configured to generate an electrical signal for generating electric field energy.

[0068] An apparatus for ablation treatment of the human duodenum, comprising the aforementioned apparatus for ablation treatment of the human digestive tract.

[0069] 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, this invention has the use of treating diabetes after duodenal ablation treatment, and also has the use of treating obesity after duodenal ablation treatment.

Claims

1. A device for ablation therapy of the human digestive tract, characterized in that, It includes: Slender inner guide rod; A slender outer sleeve is slidably fitted onto the inner guide rod along the length of the inner guide rod; An expandable component surrounds the inner guide rod and is located near the front portion of the inner guide rod, wherein the expandable component includes: A support frame is provided, which has a contracted working state and an expanded working state. The support frame includes an inner support frame and multiple outer support rods. The inner support frame includes a front support frame, a middle support frame, and a rear support frame connected in sequence. The front end of the front support frame is connected to the front of the inner guide rod, and the rear end of the rear support frame is connected to the front of the outer sleeve. In the expanded working state, the front support frame gradually moves away from the inner guide rod from front to back, and the rear support frame gradually moves away from the inner guide rod from back to front. The middle support frame has multiple middle support rods parallel to the inner guide rod and distributed in a circumferential direction, with each middle support rod maintaining the same distance from the inner guide rod. Each outer support rod is fixedly connected to each middle support rod. Each outer support rod has a front extension section extending forward of the middle support rod, and / or a rear extension section extending backward of the middle support rod, such that the length of the outer support rod in the front-back direction is greater than the length of the middle support rod in the front-back direction. A flexible electrode array membrane is provided, wherein the electrode array membrane is provided with multiple electrodes coupled to a signal generator for generating electric field energy. The electrode array membrane is disposed on the outer support rod. When the support frame is in an expanded working state, the outer support rod supports the electrode array membrane outward. When the support frame is in a contracted working state, the electrode array membrane is rolled up or / and folded on the outer support rod.

2. The device for ablation therapy of the human digestive tract according to claim 1, characterized in that: The front support frame includes multiple front support rods, the front ends of which are fixedly connected to the front of the inner guide rod; the rear support frame includes multiple rear support rods, the rear ends of which are fixedly connected to the front of the outer sleeve; the front ends of each middle support rod are respectively connected to the rear ends of each front support rod, and the rear ends of each middle support rod are respectively connected to the front ends of each rear support rod; the outer support rods are circumferentially distributed around the inner guide rod, and are parallel to the inner guide rod.

3. The device for ablation therapy of the human digestive tract according to claim 2, characterized in that: The rear end of the front support rod is connected to the front end of the middle support rod to form a front connecting part, and the front end of the rear support rod is also connected to the rear end of the middle support rod to form a rear connecting part. When the support frame is in an expanded working state, the front connecting part is in a bent state, and the rear connecting part is also in a bent state.

4. The device for ablation therapy of the human digestive tract according to claim 2, characterized in that: The inner support frame is made of shape memory alloy material, and the shape of the support frame in the expansion working state is the memory shape of the inner support frame.

5. The apparatus for ablation therapy of the human digestive tract according to claim 2, characterized in that: When the support frame is in the expanded working state, the multiple front support rods are arranged radially backward with the connection point with the inner guide rod as the center; the multiple rear support rods are arranged radially forward with the connection point with the outer sleeve as the center.

6. The apparatus for ablation therapy of the human digestive tract according to claim 1, 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 outer support rods, with its inner end fixedly connected to the support frame and its outer end being a free end. During the transition from a contraction to an expansion state, the outer support rods support the electrode array membrane outwards, causing the diameter of the outermost layer of the electrode array membrane to gradually increase and the total number of turns to gradually decrease. Conversely, during the transition from an expansion to a contraction state, the self-contracting elastic force of the electrode array membrane causes its diameter to gradually decrease and the total number of turns to gradually increase.

7. The apparatus for ablation therapy of the human digestive tract according to claim 1 or 6, characterized in that: The width of the electrode array film in the front-to-back direction is greater than or equal to the length of the outer support rod in the front-to-back direction, and the length difference between the two is less than or equal to 2 mm.

8. The apparatus for ablation therapy of the human digestive tract according to claim 1, characterized in that: The length of the outer support rod in the front-to-back direction is greater than the length of the middle support frame in the front-to-back direction.

9. The apparatus for ablation therapy of the human digestive tract according to claim 8, characterized in that: The length of the outer support rod in the front-to-back direction is 1.5 to 10 times the length of the middle support frame in the front-to-back direction.

10. The apparatus for ablation therapy of the human digestive tract according to claim 1, characterized in that: The number of external support rods is 5-12.

11. The apparatus for ablation therapy of the human digestive tract according to claim 1, characterized in that: When the support frame is in an expanded working state, the length of the outer support rod in the front-to-back direction is greater than the length of the inner support frame in the front-to-back direction.

12. The apparatus for ablation therapy of the human digestive tract according to claim 1, characterized in that: It also includes an operating handle disposed at the rear of the outer tube and / or the inner guide rod, wherein the operating handle is provided with a position adjustment device for adjusting the inner guide rod to slide relative to the outer tube in the front-back direction, or the operating handle is provided with a position adjustment device for adjusting the outer tube to slide relative to the inner guide rod in the front-back direction.

13. A system for ablation therapy of the human digestive tract, characterized in that, It includes the apparatus for ablation treatment of the human digestive tract as described in claims 1-12, and it further includes: A signal generator configured to generate an electrical signal that generates electric field energy.

14. A device for ablation therapy of the human duodenum, characterized in that, It includes the apparatus for ablation treatment of the human digestive tract as described in claims 1-12.

15. The use of the device for ablation treatment of the human duodenum as described in claim 14 in the treatment of diabetes.

16. The use of the device for ablation treatment of the human duodenum as described in claim 14 in the treatment of obesity.

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