An adaptive fist cutting hemostatic electrode assembly and electrode thereof

Abstract

This invention belongs to the field of medical device technology and relates to an adaptive fistula cutting and hemostasis electrode assembly and its electrode. The assembly includes a tube body, with an electrode head and an irrigation port at the distal end. The electrode head includes a cutting electrode and an external spring electrode pair. The cutting electrode is located at the distal end of the tube body and is isolated from the external spring electrode pair by an insulating block. The external spring electrode pair includes a distal electrode and a proximal electrode sleeved around the periphery of the tube body. The distal and proximal electrodes are spaced apart axially. In their natural state, both the distal and proximal electrodes have a shape where their mid-diameter gradually decreases towards the distal and proximal ends, respectively, and the mid-diameter of both the distal and proximal electrodes is larger than the diameter of the cutting electrode. A tightening sleeve is also sleeved around the external spring electrode, capable of tightening the distal and proximal electrodes and moving them axially along the tube body. This invention solves the technical problem that existing anal fistula surgical electrodes cannot simultaneously perform cutting and hemostasis at different fistula diameters.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to an adaptive fistula cutting and hemostasis electrode assembly and its electrode. Background Technology

[0002] Electrosurgical ablation instruments, such as electrocautery knives, electrocoagulation forceps, ultrasonic scalpels, and electrocoagulation forceps, are frequently used in surgical procedures for anal fistulas. Currently, the main surgical methods for anal fistulas include the following, and their respective advantages and disadvantages are summarized below: 1. Anal fistula incision. Procedure: The fistula is longitudinally incised, necrotic tissue is removed, and drainage is established. Applicable to: Low-lying simple anal fistulas (fistula located below the anorectal ring). Disadvantages: Large wound, longer healing time; may damage the sphincter muscles, leading to anal deformity or mild incontinence; contraindicated for high-lying fistulas, as severing the anorectal ring may cause severe incontinence.

[0003] 2. Anal fistula excision. Procedure: Complete excision of the fistula tract and surrounding scar tissue (cold knife or electrocautery). Applicable to: Low-lying fistulas with significant fibrosis. Disadvantages: Larger wound, significant postoperative pain; high risk of anal deformity, possible permanent incomplete closure; prone to complications such as infection, false healing, or anal stenosis.

[0004] 3. Anal fistula seton placement. Procedure: A rubber band or medicated thread is threaded through the fistula tract, and the fistula is slowly cut and drained. Applicable to: High or complex anal fistulas (avoid cutting the sphincter muscle in one go). Disadvantages: Persistent dull pain after surgery, long recovery period; possible residual anal laxity or leakage; high recurrence rate (especially when the internal opening is not thoroughly treated).

[0005] 4. Electrosurgical techniques (such as electrocautery and microneedling). Procedure: (1) Electrocautery: High-frequency current thermal coagulation of the wound, inhibiting bacteria and promoting healing; (2) Microneedling: Targeted drainage of multiple internal openings, preserving the sphincter muscles. Application: High-frequency current thermal coagulation of the wound, inhibiting bacteria and promoting healing. Disadvantages: Electrocautery is only an adjunct treatment and cannot replace surgical debridement; the applicability of microneedling technology needs to be verified, and there is a lack of data to support its long-term efficacy.

[0006] In actual medical records, anal fistulas have the following types: 1. Simple anal fistula. Fistula opening correspondence: a single internal opening corresponds to a single external opening. Typical characteristics: the fistula tract has no branches and connects the internal and external openings in a straight line.

[0007] 2. Complex anal fistula. Fistula opening correspondence: one-to-many or many-to-many. Typical characteristics: the fistula branches form a network structure, which may include: (1) a single internal opening corresponding to multiple external openings (branch drainage); (2) multiple internal openings corresponding to multiple external openings (multiple sources of infection).

[0008] 3. Blind fistula. Fistula opening correspondence: There is only a single fistula opening. Typical characteristics: (1) There is an external opening but no internal opening; (2) There is an internal opening but no external opening.

[0009] The surgical efficiency of all the above-mentioned surgical techniques for the various types of anal fistulas is not ideal. In particular, for complex anal fistulas (especially high-level fistulas), not only is there a problem with surgical efficiency, but also multiple challenges such as efficacy and functional preservation. The core difficulties and challenges are as follows: 1. Difficulty in locating the internal opening. The internal opening of a high-level fistula is often hidden, making it easy to miss multiple sources of infection, which is a major cause of recurrence in clinical practice.

[0010] 2. Sphincter function protection. High-level fistulas that traverse the anorectal ring are prone to sphincter damage during surgery, clinically manifesting as a risk of anal incontinence.

[0011] 3. Delayed wound healing. After debridement of deep fistulas, large cavities are formed, resulting in poor drainage. Clinically, the healing time is generally greater than 3 months, and the infection rate is increased.

[0012] 4. Complex fistula branches are difficult to manage. Horseshoe fistulas spread in a ring shape, requiring complete opening of all branches, resulting in long surgical time and significant challenges in trauma control.

[0013] 5. Regardless of the type of fistula, each fistula tract needs to be opened using a probe. After opening the fistula tract, the waste tissue needs to be scraped off again using the electrode disclosed in Chinese Patent CN201610334566.7. However, during the scraping off of waste tissue, some areas may bleed again. In this case, the solution disclosed in Chinese Patent CN201610334566.7 cannot meet the clinical needs for hemostasis again. At the same time, it also has the problem of poor hemostatic effect due to poor fit with the fistula tract.

[0014] Therefore, there is an urgent clinical need for a device that can significantly improve the efficiency of anal fistula surgery and ensure or even improve the treatment effect. Summary of the Invention

[0015] Therefore, the purpose of this invention is to provide an adaptive fistula cutting and hemostasis electrode assembly and its electrode, so as to solve the technical problem that existing anal fistula surgical electrodes cannot simultaneously perform cutting and hemostasis under different diameter sizes.

[0016] The technical solution provided by this invention is as follows: An adaptive fistula cutting and hemostasis electrode assembly includes a tube body, with an electrode head and an irrigation port at the distal end of the tube body. The electrode head includes a cutting electrode and an external spring electrode pair. The cutting electrode is located at the distal end of the tube body and is isolated from the external spring electrode pair by an insulating block. The external spring electrode pair includes a distal electrode and a proximal electrode sleeved around the periphery of the tube body. The distal electrode and the proximal electrode are spaced apart along the axial direction. In their natural state, both the distal electrode and the proximal electrode have a shape in which the diameter at the middle gradually decreases towards the distal and proximal ends, respectively, and the diameter at the middle of both the distal electrode and the proximal electrode is larger than the diameter of the cutting electrode. The irrigation port is located between the cutting electrode and the distal electrode, and also between the distal electrode and the proximal electrode. The external spring electrode is further sleeved with a tightening sleeve capable of tightening the distal electrode and the proximal electrode and moving them along the axial direction of the tube body.

[0017] The external spring electrode pair has at least the following four states: (1) When the tightening cylinder moves to the proximal end, the distal electrode and the proximal electrode are fully exposed; (2) When the tightening cylinder moves to the middle of the outer spring electrode pair, only the far end electrode is exposed; (3) When the tightening cylinder moves to the far end, the end of the far electrode that is close to the proximal electrode is partially covered. (4) When the tightening cylinder moves to the far end, the far end electrode and the near end electrode are completely covered.

[0018] Furthermore, the tightening cylinder has a spiral cut in the middle.

[0019] Furthermore, in its natural state, the degree to which the distal electrode protrudes outward from the tube body is less than or equal to the degree to which the proximal electrode protrudes outward from the tube body.

[0020] Furthermore, the exposed surface areas of the distal electrode and the proximal electrode are the same.

[0021] Furthermore, the cutting electrode can be any shape among sheet-like, tubular, and arc-shaped.

[0022] Furthermore, the cutting electrode protrudes to a lesser extent than the distal electrode.

[0023] Furthermore, the exposed area of ​​the cutting electrode is smaller than the exposed area of ​​the distal electrode.

[0024] Furthermore, the diameter of the tightening cylinder is less than or equal to the diameter of the cutting electrode.

[0025] Furthermore, the tube body includes, from the inside out, a central electrode tube, a central electrode tube insulating layer, an inner electrode tube, an inner insulating layer, an outer electrode tube, and an outer insulating layer; an inlet channel is provided between the central electrode tube insulating layer and the inner electrode tube; the inlet channel is connected to the irrigation port.

[0026] Furthermore, the end face of the cutting electrode is provided with a traction hole that connects to the central electrode tube.

[0027] Furthermore, at least one of the axial electrode tube, inner electrode tube, and outer electrode tube is a flexible tube.

[0028] Furthermore, the tube body is made into a flexible structure using spiral cuts or snake-bone hinges.

[0029] Furthermore, the proximal end of the internal electrode tube is connected to an inlet tube; one end of the inlet tube is connected in sequence to an inlet channel and an injection port, and the other end is used to clamp in the peristaltic pump and connect to the fluid device.

[0030] An adaptive fistula cutting and hemostasis electrode includes a handle, a cable plug, and the aforementioned adaptive fistula cutting and hemostasis electrode assembly; the distal end of the handle is connected to the proximal end of the tube body, the proximal end of the handle is connected to the cable plug, and the cable plug conducts the cutting electrode, the distal electrode, and the proximal electrode through wires respectively.

[0031] Compared with the prior art, the main beneficial effects of the present invention are: This invention improves the structure of the electrode assembly by adding an external spring electrode pair and a tightening cylinder. The two electrodes of the external spring electrode pair (distal and proximal electrodes) have a gradually decreasing diameter from the middle towards the distal and proximal ends, respectively. This gradual shape facilitates the movement of the external spring electrodes within the fistula and further facilitates tightening under the pressure of small-diameter fistulas, adapting to fistulas of different diameters. Combined with the movable tightening cylinder, it is easier to control the exposure and tightening degree of the distal and proximal electrodes, assisting in tightening the external spring electrode pair. An irrigation port is provided between the cutting electrode and the distal electrode, and another irrigation port is provided between the distal and proximal electrodes, facilitating the infusion of physiological saline. This ensures the physiological saline environment required for the cutting mode and provides a suitable thermal effect for the hemostasis mode, preventing scab formation and blade adhesion due to excessive temperature. This structural design allows the cutting electrode to work with the distal and proximal electrodes to form different working modes (such as cutting mode and hemostasis mode). For example, in cutting mode, the tightening cylinder allows the distal electrode to have three states to adapt to fistulas of different sizes. In hemostasis mode, the procedure is generally performed after the cutting mode. Therefore, after cutting, the tightening cylinder can be moved to the appropriate position. The external elastic electrode can adhere more tightly to the fistula tissue under its own elasticity, resulting in better hemostasis. Therefore, this invention solves the technical problem that existing anal fistula surgical electrodes cannot simultaneously perform cutting and hemostasis at different fistula diameters. Attached Figure Description

[0032] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly described below. Obviously, the drawings described below are merely some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort. The above and other objects, features, and advantages of the present invention will become clearer through the accompanying drawings. In all the drawings, the same reference numerals indicate the same parts. The drawings are not intentionally drawn to scale to actual dimensions; the focus is on illustrating the main points of the invention.

[0033] Figure 1 Schematic diagram of the overall electrode structure Figure 1 ; Figure 2 Schematic diagram of the overall electrode structure Figure 2 ; Figure 3 This is an exploded view of the tube structure; Figure 4 Schematic diagrams (a) and (b) of the external spring electrode pair; Figure 5 This is a schematic diagram showing the connection relationship of the main components; Figure 6 for Figure 5A magnified view of a section at point A in the middle; Figure 7 for Figure 5 A magnified view of a section at point B in the middle; Figure 8 Schematic diagram of the state of the external spring electrode pair (1)-(4); Figure 9 This is a schematic diagram illustrating the clinical application of the present invention in anal fistula surgery—cutting mode; Figure 10 This is a schematic diagram illustrating the clinical application of the present invention in surgery for anal fistula—hemostasis mode; Figure 11 This is a schematic diagram of the interaction between a shield-type electrode and a probe.

[0034] Figure label: 1. Tube body, 2. External spring electrode pair, 3. Inlet tube, 5. Handle, 6. Cable plug, 7. Probe; 1-1-Inner electrode tube, 1-2-Inner insulation layer, 1-3-Outer electrode tube, 1-4-Outer insulation layer, 1-5-Inlet channel, 1-6-Tightening cylinder, 1-7-Helical cut, 1-8-Axis electrode tube, 1-9-Cutting electrode, 1-10-Axis tube insulation layer, 1-11-Insulating block; 2-1. Distal electrode; 2-2. Proximal electrode; 6-1. Wire; 1-5-1. Irrigation inlet; 1-8-1, Traction Hole; → Direction of saline solution flow; Y. Tourniquet. Detailed Implementation

[0035] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0036] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0037] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0038] Fluids: In this invention, fluids mainly refer to physiological saline, etc.

[0039] Proximal end: refers to the rear end, which is also the direction away from the electrode insertion.

[0040] Distant end: refers to the front end, which is also the direction in which the electrode is inserted.

[0041] Exposed area: refers to the area located on the outside that can contact the tissue.

[0042] Externally elastic electrode pair: refers to two electrodes that are in an expanded state (i.e., expanding outwards from the tube) in their natural state, and that can retract into the tube after being compressed by an external force (such as a tightening cylinder).

[0043] Navigation path: that is, the channel built by probe 7, such as the path formed after guiding any inner port to any outer port.

[0044] Example 1, see attached document Figure 1-10As shown, for anal fistula surgery, this invention mainly considers the use of a plasma host, but of course, the use of other energy hosts, such as radio frequency hosts, is not excluded. This invention provides an adaptive fistula cutting and hemostasis electrode, comprising a tube body 1, an electrode head 2, an inlet tube 3, a handle 5, and a cable plug 6; wherein, the tube body 1 includes, from the inside out, a central electrode tube 1-8, a central electrode tube insulation layer 1-10, an inner electrode tube 1-1, an inner insulation layer 1-2, an outer electrode tube 1-3, and an outer insulation layer 1-4; the electrode head 2 includes a cutting electrode 1-9 and the aforementioned external spring electrode pair, the external spring electrode pair including a distal electrode 2-1 and a proximal electrode 2-2; the distal electrode 2-1 is fitted around the outer periphery of the distal end of the inner electrode tube 1-1, and the proximal electrode 2-2 is fitted around the outer periphery of the distal end of the outer electrode tube 1-3; both the distal electrode 2-1 and the proximal electrode 2-2 protrude outwards from the tube body 1, forming a front-to-back spaced distribution structure; in the natural state, the degree to which the distal electrode 2-1 protrudes outwards from the tube body 1 is less than or equal to the degree to which the proximal electrode 2-2 protrudes outwards from the tube body 1. The cutting electrode 1-9 is located at the distal end of the axial electrode tube 1-8 and protrudes outward from the tube body 1. The axial electrode tube 1-8 and the inner electrode tube 1-1 are isolated by the axial electrode tube insulation layer 1-10, and the cutting electrode 1-9 and the inner electrode tube 1-1 are isolated by the insulating block 1-11. The insulating block 1-11 is flush with the outer edge of the inner electrode tube 1-1 as much as possible. The insulating block 1-11 is generally made of ceramic material. The insulating block 1-11 can be sleeved on the outer side of the axial electrode tube insulation layer 1-10 or directly sleeved on the outer side of the axial electrode tube 1-8. However, the distal end of the insulating block 1-11 needs to abut against the cutting electrode 1-9, and the proximal end of the insulating block 1-11 abuts against the inner electrode tube 1-1 or is inserted inside the inner electrode tube 1-1. If necessary, it can be fixed by applying glue. The distal electrode 2-1 has several infusion ports 1-5-1 circumferentially arranged at two positions on its distal end. One is located between the distal electrode 2-1 and the proximal electrode 2-2 (i.e., at the interval between them), and the other is located between the cutting electrode 1-9 and the distal electrode 2-1. The infusion ports 1-5-1 at each position are usually evenly distributed circumferentially, such as setting 1, 2, or 3 circles, and it is also possible to set only 1 circle with only 1 or 2 ports. The most convenient method is to provide an inlet channel 1-5 between the insulating layer 1-10 of the axial tube and the inner electrode tube 1-1. One end of the inlet tube 3 is connected to the inlet channel 1-5 and the infusion ports 1-5-1 in sequence, and the other end is used to clamp in the peristaltic pump (not shown in the figure) and connect to the fluid device (i.e., physiological saline bag, not shown in the figure). The proximal end of the inlet channel 1-5 is sealed by a water collection block and connected to the inlet tube 3. That is, it is only necessary to set the inlet 1-5-1 on the inner electrode tube 1-1, and there is no need to consider whether to add the inlet 1-5-1 on the insulating block 1-11.Generally, it is preferable to independently connect the two irrigation ports 1-5-1 to the inlet pipe 3 and the fluid device. Alternatively, they can be connected to the same fluid device at the proximal end via a T-junction, which is a conventional design and will not be elaborated further. The distal end of the handle 5 is connected to the proximal end of the tube body 1. The proximal end of the handle 5 is connected to the cable plug 6. The cable plug 6 is connected to the axial electrode tube 1-8, the inner electrode tube 1-1, and the outer electrode tube 1-3 via wires 6-1 to conduct the cutting electrode 1-9, the distal electrode 2-1, and the proximal electrode 2-2. The inlet pipe 3 extends out from the proximal end of the handle 5. The cutting electrode 1-9 can be any shape, such as sheet-like, tubular, or arc-shaped. The exposed area of ​​the cutting electrode 1-9 is smaller than that of the distal electrode 2-1, and the degree to which the cutting electrode 1-9 protrudes outward from the tube body 1 is less than that of the distal electrode 2-1. The outer diameter of the tube body 1 can be 3mm, 3.5mm, 4mm, 4.5mm, 5mm, 5.5mm, 6mm, etc. It should be noted that the above dimensions are merely illustrative examples and are not intended to limit the scope of protection of this invention. The proximal end of the tube body 1 passes through the handle 5, and the welding points of the wire 6-1 with the inner electrode tube 1-1 and the outer electrode tube 1-3 are located inside the handle 5. Details regarding the arrangement of the handle 5, the cable plug 6, and the adaptive fistula cutting and hemostasis electrode assembly are conventional techniques and will not be elaborated further.

[0045] In this embodiment, the axial electrode tube 1-8, inner electrode tube 1-1, and outer electrode tube 1-3 are preferably made of materials that combine conductivity, support, and flexibility, such as T2 copper, tungsten copper alloy, platinum-iridium alloy, and SUS304 stainless steel tube, so that the operator can easily bend them manually by applying a certain force. Of course, at least one of the axial electrode tube 1-8, inner electrode tube 1-1, and outer electrode tube 1-3 can also be a flexible tube, such as the axial electrode tube 1-8 being a flexible tube, the inner electrode tube 1-1 being a flexible tube, or the outer electrode tube 1-3 being a flexible tube, or even all of the axial electrode tube 1-8, inner electrode tube 1-1, and outer electrode tube 1-3 being flexible tubes. The flexible tube is preferably made of a spiral cut 1-7 or a snake-bone hinge to form a flexible structure, or the inner electrode tube 1-1 and outer electrode tube 1-3 can be hollowed out along the axial direction to form several hollow areas. If a flexible tube structure is used, the range of materials that can be selected for the central electrode tube 1-8, inner electrode tube 1-1, and outer electrode tube 1-3 is wider, meaning materials with higher hardness can be chosen. The inner insulation layer 1-2 and outer insulation layer 1-4 are typically made of heat-shrink tubing such as PVC or FEP, ensuring both the flexibility of the tube and providing a channel for saline solution (equivalent to retaining the original inlet channel 1-5 in the inner electrode tube 1-1). The above is merely an example of a partial implementation of the flexible structure and is not limited to the scope of protection of this invention; other existing flexible structures can also be referenced. The advantage of applying the above flexible structure in this invention is that it is applicable to a wider range of fistula types, such as long and curved fistulas.

[0046] To adapt to fistulas of various diameters, this invention introduces the aforementioned external spring electrode pair. The external spring electrode pair is made of springs or spring sheets, forming a lantern-shaped, spherical, or ellipsoidal shape with gaps (the diameter gradually decreases from the central end to the proximal end, respectively). The external spring electrode pair can be welded to its corresponding electrode tube, which serves as a conductive, supporting, and connecting component. If the external spring electrode pair is made of springs in the aforementioned shapes, even if the springs are made of circular cross-section wires, the relatively laterally distributed wires of the springs can "scrape" away the clotted scabs and blood clots, exposing fresh tissue without causing new trauma.

[0047] In its natural state, both the distal electrode 2-1 and the proximal electrode 2-2 have a shape where the diameter gradually decreases from the middle towards the distal and proximal ends, respectively, and the middle diameter of both the distal electrode 2-1 and the proximal electrode 2-2 is larger than the diameter of the cutting electrode 1-9. The materials used for the distal electrode 2-1 and the proximal electrode 2-2 are generally consistent with those of the inner electrode tube 1-1 and the outer electrode tube 1-3, such as T2 copper, tungsten-copper alloy, platinum-iridium alloy, or SUS304 stainless steel. It should be noted that the shape here refers to the shape of the main functional part when hemostasis of the fistula. In addition to lantern-shaped, spherical, and ellipsoidal shapes, transitional sections that contract towards the tube body 1 can be provided at both ends along the axis of the tube body 1.

[0048] In use, this invention can be configured with two operating modes based on the connected host: hemostasis mode and cutting mode. In hemostasis mode, the cutting electrodes 1-9 are inactive, and only the external elastic electrode pair is active, forming a distal electrode 2-1 and a proximal electrode 2-2 with opposite polarities. The external elastic electrode pair adheres to the inner wall of the fistula, forming a cylindrical or annular tourniquet. In this mode, the main function of the external elastic electrode pair is to open the fistula, especially the fistula tissue located between the distal electrode 2-1 and the proximal electrode 2-2, which is affected by the thermal effect of the external elastic electrode pair. If there is a bleeding point at this location, hemostasis can be achieved quickly and effectively. In cutting mode, the external elastic electrode pair can optionally disable the proximal electrode 2-2, with the cutting electrode 1-9 acting as the working electrode and the distal electrode 2-1 as the return electrode. The cutting electrode 1-9 can generate plasma in a saline environment to perform cutting.

[0049] To integrate the cutting electrodes 1-9 and the external spring electrode pair onto a single electrode, and to achieve hemostasis and cutting modes usable in the fistula, the external spring electrode pair needs to be combined with the tightening cylinder 1-6. The tightening cylinder 1-6 is made of non-metallic materials (such as polyvinyl chloride, high-density polyethylene, etc.), or is made of the aforementioned metallic materials and then insulated. The tightening cylinder 1-6 needs to achieve a segmented function of "flexible in the middle (spiral incision) + rigid at both ends," which is a conventional technique and will not be elaborated further. That is, the tightening cylinder 1-6 is fitted over the tube body 1, allowing it to move freely axially. When the tightening cylinder 1-6 is moved to the external spring electrode pair, it can compress and contract the distal electrode 2-1 and proximal electrode 2-2 at the corresponding positions, bringing them closer to the tube body 1. The external spring electrode pair has at least the following four states: (1) When the tightening cylinder 1-6 moves to the proximal end, the distal electrode 2-1 and the proximal electrode 2-2 are fully exposed; (2) When the tightening cylinder 1-6 moves to the middle of the outer spring electrode pair, only the distal electrode 2-1 is exposed; (3) When the tightening cylinder 1-6 moves to the far end, the end of the far electrode 2-1 that is close to the proximal electrode 2-2 is partially covered. (4) When the tightening cylinder 1-6 moves to the far end, the far end electrode 2-1 and the near end electrode 2-2 are completely covered.

[0050] To ensure better cutting results, the diameter of the tightening cylinder 1-6 is less than or equal to the diameter of the cutting electrode 1-9, especially when the external spring electrode pair is in state (4), the cutting electrode 1-9 is more conducive to cutting than in states (3), (2), and (1). The degree to which the distal electrode 2-1 protrudes outward from the tube body 1 is less than or equal to the degree to which the proximal electrode 2-2 protrudes outward from the tube body 1. This structure facilitates the contact between the external spring electrode pair and the fistula, forming a cylindrical or annular tourniquet. The shape of the tourniquet here mainly depends on the degree to which the distal electrode 2-1 and the proximal electrode 2-2 protrude outward from the tube body 1. Therefore, cylindrical or annular can be considered as a general outline description, which may also include trapezoidal cylindrical shapes (which can be classified as cylindrical here).

[0051] Preferably, the exposed surface areas of the distal electrode 2-1 and the proximal electrode 2-2 are the same, although it is not excluded that the exposed surface area of ​​either the distal electrode 2-1 or the proximal electrode 2-2 may be slightly larger than that of the other. The purpose of this design is to ensure that the hemostatic effect produced by the distal electrode 2-1 and the proximal electrode 2-2 acting on the fistula is as similar as possible, such as the same hemostatic depth.

[0052] The cutting electrodes 1-9 can be any shape, such as sheet-like, tubular, or arc-shaped. The degree to which the cutting electrodes 1-9 protrude outward from the tube body 1 is less than or equal to the degree to which the distal electrode 2-1 protrudes outward from the tube body 1. For example, when the cutting electrodes 1-9 are arc-shaped, the cutting electrodes 1-9 and the axial electrode tube 1-8 form a shape similar to a nail.

[0053] To ensure better scraping effect, the distance L1 between the proximal end of the cutting electrode 1-9 and the center of the distal electrode 2-1 can be set as large as possible. Generally, the distance L2 between the centers of the distal electrode 2-1 and the proximal electrode 2-2 is less than or equal to the distance L1 between the proximal end of the cutting electrode 1-9 and the center of the distal electrode 2-1. In another option, the outer edge of the cutting electrode 1-9 can be made to protrude slightly outward from the tube body 1, and if necessary, it can be close to or equal to the degree to which the distal electrode 2-1 protrudes outward from the tube body 1. Of course, a solution that combines both of the above settings can also be selected.

[0054] To ensure effective puncture and scraping, the exposed area of ​​the cutting electrode 1-9 is smaller than that of the distal electrode 2-1. This is to ensure stable plasma excitation when connected to the plasma generator. The puncture described here is energy puncture; that is, after adding the axial electrode tube 1-8 and the cutting electrode 1-9, the present invention selects the cutting mode after connecting to the generator. The cutting electrode 1-9 serves as the working electrode, and the distal electrode 2-1 serves as the return electrode. The irrigation port 1-5-1 can be filled with physiological saline to provide a good working environment for the cutting electrode 1-9 and the distal electrode 2-1. The plasma energy concentrated on the cutting electrode 1-9 is used to forcibly open the fistula. Simultaneously, the outer edge of the cutting electrode 1-9 can be used to scrape away waste tissue in the fistula, resulting in cleaner fistula treatment. Plasma excitation, besides requiring connection to the plasma generator, is generally controlled by a foot switch (not shown in the attached diagram) or a hand switch (not shown in the attached diagram) added to the handle 5. This part is existing technology and will not be elaborated further.

[0055] The following is a description of the clinical application scenarios of this invention: Regardless of the type of anal fistula (including blind fistula), the internal and external openings of the fistula are first opened with a probe. This invention integrates cutting electrodes 1-9, external spring electrodes, and tightening cylinder 1-6, enabling the invention to simultaneously cut and stop bleeding in anal fistula surgery, directly replacing the function of the probe in opening the internal and external openings of the fistula. That is, first move the tightening cylinder 1-6 to put the external spring electrodes in state (4), (3), or (2), turn on the cutting mode of the main unit, and then use the cutting electrodes 1-9 to remove excess ulcerated tissue, thereby completing the initial hemostasis; then move the tightening cylinder 1-6 to put the external spring electrodes in state (1), turn on the hemostasis mode of the main unit, at which time the cutting electrodes 1-9 do not work, and the external spring electrodes are used to perform secondary hemostasis on the tissue between the distal electrode 2-1 and the proximal electrode 2-2. Since this embodiment does not directly use a flexible tube structure, if a more curved fistula is encountered, the tube body 1 needs to be bent manually, which is more laborious and time-consuming. For complex anal fistulas, the above procedure can be repeated. After fistula treatment, medication can usually be injected into the fistula tract to allow it to contact fresh tissue and accelerate recovery. Because this invention uses an external spring electrode pair, which is made of springs or spring sheets in a lantern-shaped, spherical, or ellipsoidal shape with gaps, it is impossible to achieve precise, non-field-of-view positioning of the bleeding point by setting a suction hole between the distal electrode 2-1 and the proximal electrode 2-2. To ensure safety, secondary hemostasis of the entire fistula is necessary. Therefore, the main advantage of this invention is that it integrates fistula cutting and hemostasis functions onto a single electrode, and can cut and stop bleeding according to fistulas of different diameters.

[0056] It is important to emphasize that the reason why this invention can adapt to fistulas of different diameters for cutting and hemostasis is: 1. In the cutting mode, the external spring electrode pair is in state (4), (3) or (2). Due to the structural characteristics of the external spring electrode pair, it can be tightened under the pressure of the small-diameter fistula, or directly adjusted by the tightening cylinder 1-6 so that it can be inserted into the fistula for cutting.

[0057] 2. In hemostasis mode, the external spring electrode pair is in state (1). Due to the structural characteristics of the external spring electrode pair, it can be tightened under the compression of the small-diameter fistula, so that it can be inserted into the fistula for hemostasis.

[0058] Regarding the technical maturity of the host component, those skilled in the art can fully implement it without creative effort based on existing descriptions. This part is not the main inventive point of this invention, so it will not be elaborated further.

[0059] Example 2, see attached document Figure 11 As shown, in this embodiment, the end face of the cutting electrode 1-9 is provided with a traction hole 1-8-1 communicating with the central electrode tube 1-8. The arrangement and function of this invention in this embodiment can be found in Chinese Patent CN202511181583.7, as this invention also uses the principle of "shield-type" ablation. This invention can still add an insulating shielding layer based on the above scheme. The insulating shielding layer can directly cover the probe 7, or it can be set in the manner disclosed in Chinese Patent CN202511181583.7. The selection of materials for the insulating shielding layer can refer to the above-mentioned insulating materials and will not be elaborated further. This insulating shielding layer is used to isolate the probe 7 from the central electrode tube 1-8 and the cutting electrode 1-9, providing more options for the selection of materials for the probe 7. The function of the probe 7 is to be directly introduced into the electrode, making it easier for the surgeon to find the fistula opening. For example, if the internal opening is found and the probe 7 is inserted, a corresponding external opening can be gradually found using the probe 7, establishing a navigation path. A spherical structure can be added to the end of the probe 7 to avoid excessive sharpness that could damage normal tissue. The inventive points of this invention can be combined in various ways based on the original scheme (such as embodiment 4). Those skilled in the art can implement it without creative effort, so it will not be described in detail here.

[0060] Because the probe 7 is used to locate the pathway between the internal and external openings one by one, regardless of the fistula correspondence, it is unnecessary to cut the target area. Low-temperature plasma (40-70℃) selectively ablates the fistula, avoiding the spread of thermal damage and preserving the integrity of the sphincter structure. The plasma directly cuts and ablates the inner wall of the fistula, and with real-time navigation, branches are thoroughly removed. The plasma itself also has a sterilization function, and the recurrence rate is estimated to be reduced by 10%-20%. Therefore, the new surgical technique provided by this invention is significantly different from existing techniques. This technique causes very little damage to the sphincter and other areas, and can significantly reduce the risk of anal incontinence. Moreover, this invention can significantly shorten the postoperative hospital stay, with an estimated hospital stay of only 1-3 days and an estimated wound healing time of 2-4 weeks.

[0061] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. An adaptive fistula cutting and hemostasis electrode assembly, characterized in that, The device includes a tube body (1), with an electrode head (2) and an inlet (1-5-1) at its distal end. The electrode head (2) includes a cutting electrode (1-9) and an external spring electrode pair. The cutting electrode (1-9) is located at the distal end of the tube body (1) and is isolated from the external spring electrode pair by an insulating block (1-11). The external spring electrode pair includes a distal electrode (2-1) and a proximal electrode (2-2) sleeved on the outer periphery of the tube body (1). The distal electrode (2-1) and the proximal electrode (2-2) are spaced apart along the axial direction. In a natural state, the distal electrode (2-1) and the proximal electrode (2-2) are... The electrodes (2-2) are all shaped with their diameters gradually decreasing from the middle to the distal and proximal ends, respectively, and the middle diameters of the distal electrode (2-1) and the proximal electrode (2-2) are both larger than the diameter of the cutting electrode (1-9); the inlet (1-5-1) is located between the cutting electrode (1-9) and the distal electrode (2-1), and also between the distal electrode (2-1) and the proximal electrode (2-2); the outer spring electrode is also fitted with a tightening cylinder (1-6) that can tighten the distal electrode (2-1) and the proximal electrode (2-2) and move them along the axial direction of the tube body (1).

2. The adaptive fistula cutting and hemostasis electrode assembly according to claim 1, characterized in that, The external spring electrode pair has at least the following four states: (1) When the tightening cylinder (1-6) moves to the proximal end, the distal electrode (2-1) and the proximal electrode (2-2) are fully exposed; (2) When the tightening cylinder (1-6) moves to the middle of the outer spring electrode pair, only the distal electrode (2-1) is exposed; (3) When the tightening cylinder (1-6) moves to the far end, the end of the far electrode (2-1) that is close to the proximal electrode (2-2) is partially covered; (4) When the tightening cylinder (1-6) moves to the far end, the far electrode (2-1) and the near electrode (2-2) are completely covered.

3. The adaptive fistula cutting and hemostasis electrode assembly according to claim 1, characterized in that, The tightening cylinder (1-6) has a spiral cut (1-7) in the middle.

4. The adaptive fistula cutting and hemostasis electrode assembly according to claim 1, characterized in that, In its natural state, the degree to which the distal electrode (2-1) protrudes outward from the tube body (1) is less than or equal to the degree to which the proximal electrode (2-2) protrudes outward from the tube body (1).

5. The adaptive fistula cutting and hemostasis electrode assembly according to claim 1, characterized in that, The distal electrode (2-1) and the proximal electrode (2-2) have the same exposed surface area.

6. The adaptive fistula cutting and hemostasis electrode assembly according to claim 1, characterized in that, The cutting electrodes (1-9) are in any shape, such as sheet, tube, or arc.

7. The adaptive fistula cutting and hemostasis electrode assembly according to claim 1, characterized in that, The cutting electrode (1-9) protrudes to the outside of the tube body (1) to a lesser extent than the distal electrode (2-1) protrudes to the outside of the tube body (1).

8. The adaptive fistula cutting and hemostasis electrode assembly according to claim 1, characterized in that, The exposed area of ​​the cutting electrode (1-9) is smaller than the exposed area of ​​the distal electrode (2-1).

9. The adaptive fistula cutting and hemostasis electrode assembly according to claim 1, characterized in that, The diameter of the tightening cylinder (1-6) is less than or equal to the diameter of the cutting electrode (1-9).

10. The adaptive fistula cutting and hemostasis electrode assembly according to claim 1, characterized in that, The external spring electrode pair is made of springs or spring sheets and is lantern-shaped, spherical, or ellipsoidal with gaps.

11. An adaptive fistula cutting and hemostasis electrode assembly according to any one of claims 1-10, characterized in that, The tube body (1) includes, from the inside out, a central electrode tube (1-8), a central electrode tube insulation layer (1-10), an inner electrode tube (1-1), an inner insulation layer (1-2), an outer electrode tube (1-3), and an outer insulation layer (1-4); an inlet channel (1-5) is provided between the central electrode tube insulation layer (1-10) and the inner electrode tube (1-1); the inlet channel (1-5) is connected to the irrigation port (1-5-1).

12. The adaptive fistula cutting and hemostasis electrode assembly according to claim 11, characterized in that, The end face of the cutting electrode (1-9) is provided with a traction hole (1-8-1) that connects to the axial electrode tube (1-8).

13. The adaptive fistula cutting and hemostasis electrode assembly according to claim 11, characterized in that, At least one of the axial electrode tube (1-8), inner electrode tube (1-1), and outer electrode tube (1-3) is a flexible tube.

14. The adaptive fistula cutting and hemostasis electrode assembly according to claim 11, characterized in that, The tube body (1) is made into a flexible structure using spiral cuts (1-7) or snake-bone hinges.

15. The adaptive fistula cutting and hemostasis electrode assembly according to claim 11, characterized in that, The proximal end of the inner electrode tube (1-1) is connected to the inlet tube (3); one end of the inlet tube (3) is connected to the inlet channel (1-5) and the inlet (1-5-1) in sequence, and the other end is used to clamp in the peristaltic pump and connect to the fluid device.

16. An adaptive fistula cutting and hemostasis electrode, comprising a handle (5) and a cable plug (6), characterized in that, It also includes an adaptive fistula cutting and hemostasis electrode assembly according to any one of claims 1-15; the distal end of the handle (5) is connected to the proximal end of the tube body (1), the proximal end of the handle (5) is connected to the cable plug (6), and the cable plug (6) is connected to the cutting electrode (1-9), the distal electrode (2-1) and the proximal electrode (2-2) respectively through the wire (6-1).

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