Navigation type electrode assembly and ablation instrument thereof

Abstract

The invention belongs to the technical field of medical instruments, and relates to a navigation type electrode assembly and an ablation instrument thereof, and the navigation type electrode assembly comprises an inner flexible electrode tube, an inner insulating layer, an outer flexible electrode tube and an outer insulating layer which are sequentially arranged from inside to outside; the far end of the inner flexible electrode tube is exposed as an electrode I, the far end of the outer flexible electrode tube is exposed as an electrode II, and the electrode I and the electrode II are opposite in electrical polarity and are isolated through an insulating block; a traction channel allowing a traction wire to penetrate is formed in the inner flexible electrode tube; during use, the traction wire penetrates through a target part to establish a navigation path, and ablation of the navigation path is achieved by introducing the traction wire into a traction channel. The technical problems that in the anal fistula operation, an inner opening is difficult to position, and complex fistula branches are difficult to treat are solved, the efficiency of the anal fistula operation can be remarkably improved, the success rate can be increased, and the function protection and recovery speed can be increased.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a navigation-type electrode assembly and an ablation device thereof. Background Art

[0002] Electrosurgical ablation devices are often used in surgical operations, such as electrosurgery, electrocoagulation forceps, ultrasonic scalpels, electrocoagulation forceps, etc. Currently, there are mainly the following surgical methods for anal fistulas, and their respective advantages and disadvantages are summarized as follows: 1. Anal fistulotomy. Procedure: Longitudinally dissect the fistula tract, remove necrotic tissue, and then allow drainage. Indicated for: Low-lying simple anal fistulas (those located below the anorectal ring). Disadvantages: Large wound area, prolonged healing time; potential sphincter damage, leading to anal deformity or mild incontinence; contraindicated for high-lying fistulas to avoid severe incontinence caused by severing the anorectal ring.

[0003] 2. Anal fistulectomy. Procedure: Complete excision of the fistula tract and surrounding scar tissue (cold knife or electrocautery). Suitable for: Low-lying fistulas with significant fibrosis. Disadvantages: Larger wound surface, significant postoperative pain; high risk of anal deformation, potentially permanent incomplete closure; and increased risk of infection, pseudohealing, or anal stenosis.

[0004] 3. Anal fistula hanging thread procedure. Procedure: A rubber band or medicated thread is passed through the fistula tract, slowly incised, and drained. Suitable for: High-positioned or complex anal fistulas (to avoid cutting the sphincter all at once). Disadvantages: Continuous dull pain and a long recovery period after surgery; possible anal laxity or leakage; and a high recurrence rate (especially if the internal opening is not thoroughly treated).

[0005] 4. Electrosurgery (e.g., electrocautery, microneedling). Procedure: (1) Electrocautery: High-frequency current heats the wound surface, inhibits bacteria and promotes healing; (2) Microneedling: Multiple internal openings for targeted drainage, preserving the sphincter. Application: High-frequency current heats the wound surface, inhibits bacteria and promotes healing. Disadvantages: Electrocautery is only an adjunctive treatment and cannot replace surgical debridement; the scope of application of microneedling technology remains to be verified, and there is a lack of data to support its long-term efficacy.

[0006] In fact, in medical records, there are many types of anal fistula: 1. Simple anal fistula. Fistula opening correspondence: Single internal opening corresponds to single external opening. Typical features: The fistula tract has no branches and connects the internal and external openings in a straight line.

[0007] 2. Complex anal fistula. Correspondence between fistula openings: one to many or many to many. Typical features: 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 infection sources).

[0008] 3. Blind fistula. Corresponding relationship of fistula opening: 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 procedures for the various types of anal fistulas mentioned above is not ideal. In particular, for complex anal fistulas (especially high-positioned ones), not only are there problems with surgical efficiency, but also multiple challenges such as efficacy and functional preservation. The core difficulties and challenges are mainly as follows: 1. Difficulty in locating the internal opening. High-positioned fistulas have hidden internal openings, making it easy to miss multiple sources of infection and the main cause of clinical recurrence.

[0010] 2. Sphincter protection: High-positioned fistulas that pass through the rectal ring can easily damage the sphincter during surgery, clinically presenting as anal incontinence.

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

[0012] 4. Complex fistula branches are difficult to treat. Horseshoe-shaped fistulas spread in a circular pattern, requiring complete opening of all branches. The surgery is time-consuming and trauma control is difficult.

[0013] Therefore, there is an urgent need in clinical practice for a device that can significantly improve the efficiency of anal fistula surgery while ensuring or even improving the treatment effect. Summary of the Invention

[0014] In view of this, the purpose of the present invention is to provide a navigation electrode assembly and its ablation instrument to solve technical problems such as the difficulty in locating the internal opening and the difficulty in handling complex fistula branches during anal fistula surgery. It can not only significantly improve the efficiency of anal fistula surgery, but also improve the success rate, functional protection and recovery speed.

[0015] The technical solutions provided by the present invention are as follows: A navigation electrode assembly comprises an inner flexible electrode tube, an inner insulating layer, an outer flexible electrode tube and an outer insulating layer, which are arranged in sequence from the inside to the outside; the distal end of the inner flexible electrode tube is exposed as electrode one, and the distal end of the outer flexible electrode tube is exposed as electrode two, and the electrical polarities of electrode one and electrode two are opposite and separated by an insulating block; the interior of the inner flexible electrode tube is a traction channel for a traction wire to pass through; when in use, the traction wire is passed through the target area to establish a navigation path, and ablation of the navigation path is achieved by introducing the traction wire into the traction channel.

[0016] Furthermore, the traction wire is a part of the navigation electrode assembly, or is independent of the navigation electrode assembly, that is, it can be provided separately as an accessory.

[0017] Furthermore, the length of the traction channel is greater than or equal to the length of the traction wire.

[0018] Furthermore, the inner flexible electrode tube, the inner insulating layer, and the outer flexible electrode tube are exposed in sequence in the proximal direction.

[0019] Furthermore, an inlet channel is formed between the inner flexible electrode tube and the outer flexible electrode tube.

[0020] Furthermore, the inlet channel includes the following configurations: (a) formed between the inner flexible electrode tube and the inner insulating layer, the inlet channel includes an inlet and an outlet, the inlet being an opening extending through the inner insulating layer at the proximal end of the outer flexible electrode tube, and the outlet being located at the second electrode; (b) formed between the inner insulating layer and the outer flexible electrode tube, the inlet channel includes an inlet and an outlet, the inlet is an opening opened at the proximal end of the outer flexible electrode tube that does not penetrate the inner insulating layer, and the outlet is located at the second electrode.

[0021] Furthermore, when the method (a) is adopted, the inner insulating layer, the outer flexible electrode tube and the outer insulating layer are fixed together.

[0022] Furthermore, the inner flexible electrode tube includes an inner supporting portion and an inner flexible portion, and the electrode 1 is arranged at the distal end of the inner flexible portion.

[0023] Furthermore, the inner flexible portion is spiral-shaped.

[0024] Furthermore, the outer flexible electrode tube includes an outer supporting portion and an outer flexible portion, and the second electrode is arranged at the distal end of the outer flexible portion.

[0025] Furthermore, the outer flexible portion is spiral-shaped.

[0026] Furthermore, an insulating shielding layer is provided in the inner flexible electrode tube.

[0027] Furthermore, the exposed area of ​​the second electrode is larger than that of the first electrode, so that the plasma can be stably excited when connected to a plasma host.

[0028] Furthermore, the electrode 1 is in any shape of sheet, tube, or arc surface.

[0029] An ablation instrument includes a handle, a cable plug, and the navigation electrode assembly described above; the distal end of the handle is connected to the proximal end of the navigation electrode assembly, the proximal end of the handle is connected to the cable plug, and the cable plug respectively connects the electrode one and the electrode two through a wire.

[0030] Compared with the prior art, the main beneficial effects of the present invention are: Due to the complexity and diversity of fistula openings, the path between the internal opening and the external opening is basically tortuous, and conventional instruments are difficult to ablate the path in a targeted manner. For example, ablation and closure of the fistula opening alone cannot achieve a therapeutic effect. Therefore, the main core point of the present invention is that a traction channel is provided to match the traction wire. The traction wire is suitable for various types of anal fistulas, and it is very convenient to find the location of the fistula opening one by one, and establish a navigation path between the internal opening and the external opening. The basis for establishing this traction channel is the internal flexible electrode tube of the present invention. The combined effect of the internal flexible electrode tube and the external flexible electrode tube and other components ensures the ablation effect. The use of the internal flexible electrode tube, the external flexible electrode tube, etc., makes the present invention have good flexibility, which can be well adapted to the navigation path established by the traction wire, and can cope with the ablation, hemostasis and closure of various types of anal fistulas. Therefore, the present invention can solve the technical problems such as the difficulty in locating the internal opening and the difficulty in handling complex fistula branches in anal fistula surgery. It can not only significantly improve the efficiency of anal fistula surgery, but also improve the success rate, functional protection and recovery speed. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following is a brief introduction to the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work. The above and other purposes, features and advantages of the present invention will become clearer through the accompanying drawings. The same reference numerals indicate the same parts throughout the drawings. The present invention does not intentionally scale the drawings to the actual size, and the focus is on illustrating the main purpose of the present invention.

[0032] Figure 1 Schematic diagram of the overall scheme; Figure 2 is a schematic diagram of an embodiment; Figure 3 is a schematic diagram of a second embodiment; Figure 4 An exploded view of the second embodiment; Figure 5 This is a schematic diagram of plasma distribution in part A of the second embodiment; Figure 6 A partial cross-sectional view of the second embodiment Figure 1 ; Figure 7 A partial cross-sectional view of the second embodiment Figure 2 ; Figure 8 Schematic diagram of the clinical application of the present invention in anal fistula.

[0033] Reference numerals: 1-Navigation electrode assembly, 2-Handle, 3-Cable plug, 4-Injection assembly, 5-Baffle, 6-Traction wire; 11-inner flexible electrode tube, 12-inner insulation layer, 13-outer flexible electrode tube, 14-outer insulation layer, 15-insulation block, 16-inlet channel, 17-insulation shielding layer, 18-traction channel; 31- wire; 41-inlet pipe; 111 - electrode 1, 112 - inner support portion, 113 - inner flexible portion; 131 - electrode 2, 132 - outer support portion, 133 - outer flexible portion; 161-inlet, 162-outlet. DETAILED DESCRIPTION

[0034] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings herein can be arranged and designed in various different configurations.

[0035] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention as claimed, but rather merely represents selected embodiments of the present invention. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without creative effort are intended to fall within the scope of protection of the present invention.

[0036] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not need to be further defined or explained in subsequent drawings.

[0037] Fluid: The present invention mainly refers to physiological saline and the like.

[0038] Proximal: refers to the end that is away from the direction of the instrument's insertion navigation path.

[0039] Distal: refers to the end of the instrument's navigation path.

[0040] Navigation path: that is, the channel constructed by the traction wire 6, such as the path formed after guiding any internal opening to any external opening.

[0041] Example 1, with reference to Figure 1-8As shown, the present invention provides a navigation electrode assembly 1, comprising an inner flexible electrode tube 11, an inner insulating layer 12, an outer flexible electrode tube 13, and an outer insulating layer 14, arranged sequentially from the inside out. The distal end of the inner flexible electrode tube 11 is exposed as electrode 1 111, and the distal end of the outer flexible electrode tube 13 is exposed as electrode 2 131. Electrode 1 111 and electrode 2 131 have opposite electrical polarities and are separated by an insulating block 15. The interior of the inner flexible electrode tube 11 defines a traction channel 18 for a traction wire 6 to pass through. The traction wire 6 acts as a probe. During use, the traction wire 6 is passed through the target site to establish a navigation path. Ablation along the navigation path is achieved by guiding the traction wire 6 into the traction channel 18. The traction wire 6 and the navigation electrode assembly 1 constitute a navigation mechanism.

[0042] The present invention provides an ablation device, including a handle 2, a cable plug 3, and the navigation electrode assembly 1 described above; the distal end of the handle 2 is connected to the proximal end of the navigation electrode assembly 1, and the proximal end of the handle 2 is connected to the cable plug 3, and the cable plug 3 is connected to the electrode 1 111 and the electrode 2 131 respectively through the wire 31.

[0043] For anal fistula surgery, the present invention mainly considers the use of connecting to a plasma host, but of course does not rule out the use of connecting to other energy hosts, such as a radio frequency host.

[0044] Generally, it is preferred that the traction wire 6 be independent of the navigation electrode assembly 1. Of course, the traction wire 6 and the navigation electrode assembly 1 can also be designed as one body, that is, the traction wire 6 is a part of the navigation electrode assembly 1, such as adding a storage mechanism. However, this will significantly increase the cost of the device, and the price of the device in the hospital will also be higher, which is not conducive to the patient's economic interests.

[0045] Specifically, this embodiment can implement the functions shown in the present invention as follows: The insulating block 15 is generally made of ceramic material.

[0046] The inner flexible electrode tube 11 includes an inner support portion 112 and an inner flexible portion 113. The first electrode 111 is disposed at the distal end of the inner flexible portion 113. The inner flexible portion 113 is spiral-shaped.

[0047] The outer flexible electrode tube 13 includes an outer support portion 132 and an outer flexible portion 133. The second electrode 131 is disposed at the distal end of the outer flexible portion 133. The outer flexible portion 133 is spiral-shaped.

[0048] In the above, the corresponding parts of the inner support part 112 and the outer support part 132 can be collectively referred to as the support part, and the corresponding parts of the inner flexible part 113 and the outer flexible part 133 can be collectively referred to as the flexible part. Under normal circumstances, the present invention will design the diameter of the flexible part to be uniform in thickness or gradually become thinner towards the distal end. Correspondingly, the size of the insulating block 15 is also designed to be of a corresponding size, that is, if the flexible part is of a uniform size, then the insulating block 15 is also made into a uniform size, and preferably the sizes of the two are made the same. Similarly, if the flexible part is of a size that gradually becomes thinner towards the distal end, then the insulating block 15 is also made into a size that gradually becomes thinner towards the distal end. Preferably, the sizes of the two are made to change continuously to achieve the purpose of smooth connection and reduce the sense of stagnation.

[0049] Strictly speaking, a small section of hard tube structure can be added to the distal end of the flexible portion (not shown in the drawings). For example, a small section of hard tube structure is preferably provided at the distal end of the inner flexible portion 113 to facilitate the insertion of the insulating block 15 and ensure the stability of the electrode 111. Similarly, a small section of hard tube structure is preferably provided at the distal end of the outer flexible portion 133. Figure 4 As shown, it is not only convenient to install the insulating block 15 and ensure the stability of the electrode 1 111, but also to ensure that the exposed area of ​​the electrode 2 131 is large enough. After the components of the present invention are installed, they can be fixed with glue to further improve safety. This is an existing mature technology and will not be described in detail.

[0050] The above is merely an example of an implementation method of providing a flexible electrode, which does not limit the protection scope of the present invention. Other existing flexible electrodes may also be used for reference.

[0051] The exposed area of ​​the second electrode 131 is larger than that of the first electrode 111. This ensures stable plasma ignition when connected to a plasma mainframe. Plasma ignition, in addition to requiring connection to a plasma mainframe, is typically controlled by a foot switch (not shown) or a hand switch (not shown) attached to the handle 2. This is prior art and will not be further elaborated.

[0052] The electrode 111 is in any shape such as sheet, tube, or arc surface. It should be noted that the shape description here is limited to a rough description. The reason is that it is preferred to set the traction channel 18 of the traction wire 6 through the electrode 111. Therefore, the end face of the electrode 111 is generally opened, or the opening itself is part of the traction channel 18. In this way, no matter what shape the electrode 111 is, there will be an opening. The above shape description includes such situations, such as designing the electrode 111 as a circular sheet, laying it flat on the tube mouth of the inner flexible electrode tube 11, and opening it at the corresponding position of the tube mouth to form the electrode 111 that is actually similar to a circular ring. At this time, the plasma is generated at the outer edge of the circular ring. Refer to the attached Figure 5 As shown. Moreover, it is preferred that the cross-sectional dimensions of the electrode 111 be designed to be larger than the outer diameter of the outer flexible electrode tube 13 (wrapped with an outer insulating layer 14). For example, the outer diameter of the outer flexible electrode tube 13 wrapped with an outer insulating layer 14 can be 3mm, 3.5mm, 4mm, 4.5mm, 5mm, 5.5mm, 6mm, etc. If an outer diameter of 3mm is selected, the cross-sectional dimensions of the electrode 111 are set to 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, etc. This allows the electrode 111 to be more thoroughly exposed, so as to fully contact the tissue on the navigation path and improve the ablation effect. Of course, since the tissue itself has a certain degree of contractility when relaxed, it is also possible to design the cross-sectional dimensions of the electrode 111 to be smaller than or equal to the outer diameter of the outer flexible electrode tube 13 (wrapped with an outer insulating layer 14). It should be noted that the above dimensions are merely an example and are not limited to the scope of protection of the present invention.

[0053] The inner flexible electrode tube 11, inner insulating layer 12, and outer flexible electrode tube 13 are exposed in sequence in the proximal direction to facilitate welding of the wires 31, thereby achieving electrical connection between the cable plug 3 and the first and second electrodes 111 and 131. The handle 2 partially or entirely encases the support portion, with the welding point for the wires 31 located within the handle 2.

[0054] Since physiological saline will be introduced and waste liquid will be generated during actual use, two issues need to be considered: one is to prevent the waste liquid from flowing back into the operator's hand, and the other is to prevent the waste liquid from entering the inside of the instrument. In order to prevent the waste liquid from flowing back into the operator's hand, a baffle 5 can be provided at the connection between the handle 2 and the navigation electrode assembly 1. In order to prevent the waste liquid from entering the traction channel 18 and contaminating or even damaging the instrument, it is not advisable to set the diameter of the traction channel 18 too large, and it is preferred to close the proximal end of the traction channel 18. The details of the setting of the handle 2, the cable plug 3, and the navigation electrode assembly 1 belong to conventional technology and do not need to be elaborated.

[0055] The solution provided in this embodiment is based on the premise that the drawing wire 6 is made of insulating material, such as aramid fiber, glass fiber, etc., which has hardness and flexibility similar to iron wire and steel wire.

[0056] Reference Attachment Figure 8 As shown, the function of the traction wire 6 is to facilitate the operator to find the fistula opening. For example, after finding the internal opening and inserting the traction wire 6, the traction wire 6 is used to gradually find a corresponding external opening (even if there is no external opening) to establish a navigation path. In order to ensure the passability of the traction wire 6 in the traction channel 18, the diameter of the traction channel 18 should be set to be larger than the diameter of the traction wire 6. In case of complex anal fistula, one end of the traction wire 6 can generally be fixed at the internal opening, and the other end can be passed out from the external opening, leaving a small section exposed outside the body to facilitate the traction wire 6 to pass into the traction channel 18, so as to perform the next ablation operation. Even in the case of a blind fistula, although one end is not convenient to fix, the navigation path has been established, which has little impact on the next ablation operation.

[0057] This embodiment lacks a built-in fluid injection mechanism, requiring separate saline injection. The present invention utilizes a conductive medium (saline) to form a highly concentrated plasma layer around the electrode. This layer possesses sufficient energy to shatter organic molecular chains within the tissue, separating them. Combined with 360-degree coaxial saline perfusion at the top, this allows for "shield-style" ablation of anal fistula tissue while effectively controlling bleeding.

[0058] This invention represents a novel minimally invasive surgical procedure for anal fistulas, termed "anal fistula navigation." Using a traction wire (6), the path between the internal and external openings is located one by one. Regardless of the fistula's corresponding location, no incision is required. Low-temperature plasma (40-70°C) selectively ablates the fistula tract, preventing the spread of thermal damage and preserving the structural integrity of the sphincter. The plasma directly ablates the inner wall of the fistula tract, and combined with real-time navigation, completely removes branches. The plasma itself also has a sterilizing function, resulting in an estimated 10%-20% reduction in recurrence rate. Therefore, the new procedure provided by this invention significantly differs from existing procedures, with minimal damage to the sphincter and other areas, significantly reducing the risk of anal incontinence. Furthermore, this invention significantly shortens postoperative hospital stays, estimated at only 1-3 days, and wound healing time is estimated at 2-4 weeks. In summary, through the innovative combination of precise navigation and low-temperature ablation, this invention significantly surpasses existing procedures in terms of surgical efficiency, success rate, functional preservation, and recovery speed, making it particularly suitable for the difficult problem of complex anal fistulas.

[0059] Example 2, see attached Figure 3-7As shown, the main difference of this embodiment is that the length of the traction channel 18 is greater than or equal to the length of the traction wire 6. The purpose of this design is obviously to ensure that the traction channel 18 can completely accommodate the traction wire 6, so as to achieve the purpose of using plasma to ablate the tissue along the navigation path, and to directly seal the fistula or use biomaterials to seal the fistula.

[0060] An inlet channel 16 is formed between the inner flexible electrode tube 11 and the outer flexible electrode tube 13 .

[0061] The inlet channel 16 includes the following configurations: (a) (not shown in the drawings) is formed between the inner flexible electrode tube 11 and the inner insulating layer 12, the inlet channel 16 includes an inlet 161 and an outlet 162, the inlet 161 is an opening opened at the proximal end of the outer flexible electrode tube 13 and penetrating the inner insulating layer 12, and the outlet 162 is located at the second electrode 131; (b) Reference Figure 6 As shown, formed between the inner insulating layer 12 and the outer flexible electrode tube 13, the inlet channel 16 includes an inlet 161 and an outlet 162, the inlet 161 is an opening opened at the proximal end of the outer flexible electrode tube 13 that does not penetrate the inner insulating layer 12, and the outlet 162 is located at the electrode 2 131.

[0062] The number of the outlets 162 is generally more than one, that is, it is preferred to set a plurality of outlets 162 evenly distributed at the second electrode 131 .

[0063] When using method (a), the inner insulating layer 12, outer flexible electrode tube 13, and outer insulating layer 14 are fixed together. In this case, the inner insulating layer 12 can be made of a relatively hard insulating material, such as ceramic (e.g., alumina) or epoxy resin, and the outer insulating layer 14 can be made of a heat shrink tubing or the same material as the inner insulating layer 12.

[0064] When the method (b) is adopted, the inner insulating layer 12 and the outer insulating layer 14 can be directly made of heat shrink tubing. It should be noted that the above material selection is only an example and does not limit the scope of protection of the present invention.

[0065] Reference Attachment Figure 7As shown, the inlet 161 is connected to the injection assembly 4 via the inlet tube 41. Therefore, the injection assembly 4 and the inlet tube 41 are also part of the present invention. A sealing member (not shown) may be added to the connection between the inlet 161 and the inlet tube 41. Since this is a mature technology, it will not be described in detail. During use of the present invention, a pressurizing device such as a peristaltic pump is typically incorporated into the inlet tube 41 to provide injection power, facilitate the smooth delivery of saline to the target area, and control the flow rate.

[0066] Example 3, see attached Figure 3-7 As shown, the main difference of this embodiment is that the inner flexible electrode tube 11 is provided with an insulating shielding layer 17. This design is intended to prevent the operator from accidentally using the conductive traction wire 6 (metal) during use, thereby avoiding safety hazards. The material selection of the insulating shielding layer 17 can be referenced to the above-mentioned insulating materials and will not be further described.

[0067] Moreover, the insulating shielding layer 17 also has a function of improving the smoothness of sliding of the traction wire 6 in the traction channel 18, thereby avoiding interference of the lower flexible portion in some embodiments.

[0068] It is worth mentioning that in order to avoid the conductive traction wire 6 from accidentally touching the electrode 111, it is preferably designed with an insulating shielding layer 17 to completely isolate the traction wire 6 from the opening of the electrode 111 (the entrance of the traction channel 18).

[0069] The foregoing description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations of the present invention are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention are intended to be within the scope of protection of the present invention.

Claims

1. A navigation electrode assembly (1), characterized in that: The invention comprises an inner flexible electrode tube (11), an inner insulating layer (12), an outer flexible electrode tube (13) and an outer insulating layer (14) which are arranged in sequence from the inside to the outside; the distal end of the inner flexible electrode tube (11) is exposed as electrode one (111), and the distal end of the outer flexible electrode tube (13) is exposed as electrode two (131); the electrical polarities of electrode one (111) and electrode two (131) are opposite and are isolated by an insulating block (15); the interior of the inner flexible electrode tube (11) is a traction channel (18) for a traction wire (6) to pass through; when in use, the traction wire (6) is passed through the target part to establish a navigation path, and ablation of the navigation path is achieved by introducing the traction wire (6) into the traction channel (18).

2. The navigation electrode assembly (1) according to claim 1, characterized in that: The traction wire (6) is a part of the navigation electrode assembly (1), or is independent of the navigation electrode assembly (1).

3. The navigation electrode assembly (1) according to claim 1, characterized in that: The length of the traction channel (18) is greater than or equal to the length of the traction wire (6).

4. The navigation electrode assembly (1) according to claim 1, characterized in that: An inlet channel (16) is formed between the inner flexible electrode tube (11) and the outer flexible electrode tube (13).

5. The navigation electrode assembly (1) according to claim 4, characterized in that: The inlet channel (16) includes the following configurations: (a) formed between the inner flexible electrode tube (11) and the inner insulating layer (12), the inlet channel (16) includes an inlet (161) and an outlet (162), the inlet (161) is an opening opened at the proximal end of the outer flexible electrode tube (13) and penetrating the inner insulating layer (12), and the outlet (162) is located at the second electrode (131); (b) formed between the inner insulating layer (12) and the outer flexible electrode tube (13), the inlet channel (16) includes an inlet (161) and an outlet (162), the inlet (161) is an opening opened at the proximal end of the outer flexible electrode tube (13) and does not penetrate the inner insulating layer (12), and the outlet (162) is located at the electrode 2 (131).

6. The navigation electrode assembly (1) according to claim 5, characterized in that: When the method (a) is adopted, the inner insulating layer (12), the outer flexible electrode tube (13) and the outer insulating layer (14) are fixed together.

7. The navigation electrode assembly (1) according to claim 1, characterized in that: The inner flexible electrode tube (11) comprises an inner support portion (112) and an inner flexible portion (113), and the electrode 1 (111) is arranged at the distal end of the inner flexible portion (113).

8. The navigation electrode assembly (1) according to claim 7, characterized in that: The inner flexible portion (113) is spiral-shaped.

9. The navigation electrode assembly (1) according to claim 1, characterized in that: The outer flexible electrode tube (13) comprises an outer supporting portion (132) and an outer flexible portion (133), and the second electrode (131) is arranged at the distal end of the outer flexible portion (133).

10. The navigation electrode assembly (1) according to claim 9, characterized in that: The outer flexible portion (133) is spiral-shaped.

11. The navigation electrode assembly (1) according to claim 1, characterized in that: An insulating shielding layer (17) is provided inside the inner flexible electrode tube (11).

12. The navigation electrode assembly (1) according to claim 1, characterized in that: The exposed area of ​​the second electrode (131) is larger than that of the first electrode (111).

13. A navigation electrode assembly (1) according to any one of claims 1 to 12, characterized in that: The electrode 1 (111) is in any shape of sheet, tube, or arc surface.

14. An ablation device, comprising a handle (2) and a cable plug (3), characterized in that: It also includes a navigation electrode assembly (1) according to any one of claims 1 to 13; the distal end of the handle (2) is connected to the proximal end of the navigation electrode assembly (1), and the proximal end of the handle (2) is connected to the cable plug (3), and the cable plug (3) is connected to the electrode 1 (111) and the electrode 2 (131) respectively through the wire (31).

Images