Multi-electrode ablation needle and pulse ablation instrument
By designing a multi-electrode ablation needle, using the insulating structure of multiple electrode assemblies and spacers, high-voltage discharge is achieved, and the problem of difficulty in puncture and arrangement of electrode needles in the prior art is solved, reducing patient pain and reducing surgical difficulty.
Patent Information
- Application Number
- CN202421062511.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-05-15
- Publication Date
- 2025-03-14
- Estimated Expiration
- 2034-05-15
AI Technical Summary
In the application of existing irreversible electroporation ablation technology in the cardiovascular field, at least two punctures are required to arrange single electrode needles, which leads to increased pain in patients. In the arrangement of electrode needles, parallelism needs to be considered and difficulties in avoiding other organs, blood vessels, nerves, and bones.
A multi-electrode ablation needle is designed, including at least two electrode assemblies, each electrode assemblies are sequentially connected from the inside to the outside, and are insulated by a spacer to achieve electroporation ablation of high-voltage discharge.
High-voltage discharge between multiple electrode assemblies can be achieved by inserting needles at one time, reducing the number of pins, reducing trauma, reducing patient pain, and reducing the difficulty of arranging electrode needles.
Smart Images
Figure CN222604663U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the technical field of ablation, in particular to a multi-electrode ablation needle and a pulse ablation instrument. Background Art
[0002] Irreversible electroporation (IRE) is a non-thermal minimally invasive tumor ablation technology. It generates a short pulse (steep pulse) of high-voltage electric field through the ablation electrode needle that percutaneously punctures into the tumor, causing permanent nanoscale electroporation on the tumor cell membrane, causing damage to the internal and external environment of the cell membrane, leading to cell apoptosis and necrosis. To achieve irreversible electroporation, the applied electric field strength must be higher than the electric field threshold of the target tissue. Since myocardial tissue only needs 400V / cm to achieve irreversible electroporation, its threshold is low and it is relatively easy to achieve. Therefore, irreversible electroporation ablation technology is widely used in the cardiovascular field.
[0003] The application of irreversible electroporation ablation technology in the cardiovascular field is achieved, for example, through electrode needles that can puncture tissues. During surgery, at least two single electrode needles need to be arranged according to the actual situation of the tumor (such as the size of the tumor, etc.), so at least two punctures are required, causing more pain to the patient; in addition, when arranging the needles, it is necessary to consider maintaining a certain degree of parallelism between the electrode needles so as not to affect the surgical effect, and it is also necessary to consider the necessity of each electrode needle avoiding other organs, blood vessels, nerves, and bones during the puncture. Therefore, it is also difficult to arrange two electrode needles that meet all requirements. Utility Model Content
[0004] The utility model provides a multi-electrode ablation needle and a pulse ablation instrument, which are used to solve at least one of the above-mentioned technical problems.
[0005] According to a first aspect of the utility model, the utility model provides a multi-electrode ablation needle, including a needle rod assembly, wherein the needle rod assembly includes at least two electrode assemblies, and each electrode assembly is sequentially sleeved and connected from the inside to the outside.
[0006] The innermost electrode assembly axially penetrates the outer electrode assembly, and the conductive portion on the innermost electrode assembly extends out of the outer electrode assembly, and an isolation member is provided between the conductive portions of each electrode assembly.
[0007] In one embodiment, the needle bar assembly comprises:
[0008] A first electrode assembly includes a first electrode rod and a first conductive portion disposed at a proximal end of the first electrode rod; and
[0009] A second electrode assembly, comprising a second electrode rod sleeved outside the first electrode rod, wherein a second conductive portion is disposed at a proximal end of the second electrode rod;
[0010] The first conductive portion is located outside the second conductive portion, and the first conductive portion and the second conductive portion are separated by the isolation member in the axial direction.
[0011] In one embodiment, a first insulating structure is provided on the outer surface of a portion of the first electrode rod located in the second electrode rod, and the isolating member is configured as an insulating ring sleeved on the first electrode rod, and the insulating ring is located between the first conductive portion and the second conductive portion.
[0012] In one embodiment, the first electrode rod is a conductive structure as a whole, and the isolation member includes an isolation tube and an isolation portion located at the proximal end of the isolation tube, the isolation tube is located between the first electrode rod and the second electrode rod, and the isolation portion is located between the first conductive portion and the second conductive portion.
[0013] In one embodiment, a second insulating structure is provided on the outer surface of the second electrode rod, and an end of the second insulating structure abuts against an end of the second conductive portion.
[0014] In one embodiment, the distal end of the first electrode rod is located outside the distal end of the second electrode rod, and the distal ends of the first electrode rod and the second electrode rod are both provided with lead terminals.
[0015] In one embodiment, the first conductive portion is configured as a puncture needle tip or a part of a puncture needle tip.
[0016] In one embodiment, it also includes a handle assembly that is arranged in an integrated or split manner, wherein an end cap is arranged on the proximal side of the handle assembly, a fixing cylinder is arranged inside the handle assembly, and the distal end of the needle rod assembly passes through the end cap and the fixing cylinder in sequence.
[0017] In one embodiment, the distal end side of the handle assembly is also provided with an LED light panel and a threading hole.
[0018] According to a second aspect of the utility model, the utility model provides a pulse ablation apparatus, comprising the above-mentioned multi-electrode ablation needle, and also comprising a high-voltage output device, which is connected to the multi-electrode ablation needle via a lead wire and / or a connector.
[0019] Compared with the prior art, the advantage of the utility model is that the needle rod assembly includes at least two electrode assemblies, and an isolation piece is provided between the two electrode assemblies to insulate the two electrode assemblies from each other. Therefore, electroporation ablation by high-voltage discharge between the two electrode assemblies can be achieved by inserting the needle once, thereby reducing the number of needles inserted when a single electrode needle is used, avoiding the trauma caused by multiple needle punctures, and reducing the pain of patients; and because there are at least two electrode assemblies on the needle rod assembly, there is no need to use it with other electrode needles when placing the needles, and there is no need to consider the influence of factors such as parallelism, thereby reducing the difficulty of placing the needles. BRIEF DESCRIPTION OF THE DRAWINGS
[0020] The present invention will be described in more detail below based on embodiments and with reference to the accompanying drawings.
[0021] Figure 1 is a cross-sectional view of a multi-electrode ablation needle in Embodiment 1 of the present utility model;
[0022] Figure 2 is an exploded view of the multi-electrode ablation needle in Example 1 of the utility model;
[0023] Figure 3 is an exploded view of the needle bar assembly in Embodiment 1 of the present utility model;
[0024] Figure 4 yes Figure 3 A partial structural schematic diagram of the first electrode assembly of the needle bar assembly shown;
[0025] Figure 5 yes Figure 3 A partial structural schematic diagram of the isolation member of the needle bar assembly shown;
[0026] Figure 6 yes Figure 3 A partial structural schematic diagram of the second electrode assembly of the needle rod assembly shown;
[0027] Figure 7 yes Figure 2 A schematic diagram of the three-dimensional structure of the end cover shown;
[0028] Figure 8 yes Figure 2 A schematic diagram of the three-dimensional structure of the fixed cylinder shown;
[0029] Fig. 9 is an exploded view of the needle bar assembly in Embodiment 2 of the present utility model;
[0030] Fig.10 yes Fig. 9 A partial structural schematic diagram of the first electrode assembly of the needle bar assembly shown;
[0031] Fig.11 yes Fig. 9A schematic diagram of the partial structure of the isolation member of the needle bar assembly shown.
[0032] Reference numerals:
[0033] 1. Needle bar assembly; 2. Handle assembly; 3. LED light board; 5. Lead wire;
[0034] 11. first electrode assembly; 12. separator; 13. second electrode assembly;
[0035] 111, first conductive portion; 112, first electrode rod; 1111, tip;
[0036] 121. isolation part; 122. isolation tube;
[0037] 131. second conductive portion; 132. second electrode rod;
[0038] 21. End cover; 22. Fixing tube; 23. Threading hole; 24. Lower shell of handle; 25. Upper shell of handle; 26. Second slot; 27. First slot;
[0039] 211. Snap ring; 221. Middle part. DETAILED DESCRIPTION
[0040] The utility model will be further described below in conjunction with the accompanying drawings.
[0041] like Figure 1 and Figure 2 As shown, the utility model provides a multi-electrode ablation needle, including a needle rod assembly 1 and a handle assembly 2, the needle rod assembly 1 includes at least two electrode assemblies, and the electrode assemblies are sequentially arranged and connected from the inside to the outside, wherein the innermost electrode assembly axially penetrates the outer electrode assembly, and an isolation piece 12 is arranged between the conductive parts of each electrode assembly.
[0042] The following description will be made by taking the example that the needle rod assembly 1 includes two electrode assemblies (ie, a first electrode assembly 11 and a second electrode assembly 13 sleeved thereon).
[0043] It should be understood that the needle bar assembly 1 may also include a third electrode assembly sleeved on the second electrode assembly, a fourth electrode assembly sleeved on the third electrode assembly, etc.; or the needle bar assembly 1 may also include a third electrode assembly sleeved on the second electrode assembly and a fourth electrode assembly arranged inside the third electrode assembly and arranged in parallel with the second electrode assembly, etc.; or the needle bar assembly 1 may also include a third electrode assembly sleeved on the second electrode assembly and a fourth electrode assembly arranged inside the second electrode assembly and arranged in parallel with the first electrode assembly, etc.
[0044] In other words, the needle bar assembly 1 may include a plurality of electrode assemblies, and each electrode assembly is nested from the inside out. Alternatively, the needle bar assembly 1 may include a plurality of electrode assemblies, some of which are nested from the inside out, and other electrode assemblies may be arranged in parallel with each other.
[0045] Example 1
[0046] like Figure 1-Figure 8 As shown, the first electrode assembly 11 includes a first electrode rod 112 and a first conductive portion 111 disposed at the proximal end of the first electrode rod 112. The first electrode rod 112 can be connected to the first conductive portion 111 in various known ways. The second electrode assembly 13 includes a second electrode rod 132 sleeved outside the first electrode rod 112, and a second conductive portion 131 is disposed at the proximal end of the second electrode rod 132.
[0047] like Figure 3 As shown, the first conductive part 111 is configured as a puncture needle tip, which is made of a conductive metal material, and the tip 1111 of the puncture needle tip can play a puncture role, and the puncture needle tip can also serve as one of the electrodes for ablation therapy. It can be understood that the first conductive part 111 can also be a conductive part that is independently configured between the first electrode rod 112 and the puncture needle tip, and serves as one of the electrodes for ablation therapy.
[0048] The diameter of the first electrode rod 112 is slightly smaller than the diameter of the first conductive portion 111 , so that the first electrode rod 112 can smoothly penetrate into the second electrode assembly 13 .
[0049] like Figure 4 As shown, the portion of the first electrode rod 112 located in the second electrode rod 132 may be insulated to ensure insulation of the first electrode rod 112 and the second electrode rod 132 except for the conductive portions of the first electrode rod 112 and the second electrode rod 132. For example, a first insulating structure may be provided on the outer surface of the portion of the first electrode rod 112 located in the second electrode rod 132, and the first insulating structure may be, for example, a heat shrink tube, a polyimide (PI) tube or an insulating coating, wherein the insulating coating may be a polyetheretherketone (PEEK) coating.
[0050] like Figure 3 As shown, the distal end of the first electrode rod 112 is provided with a lead terminal A. For example, the exposed portion of the distal end of the first electrode rod 112 is not covered by the first insulating structure, and thus can be connected to the lead 5 as a high voltage input terminal.
[0051] It can be understood that the lead terminal A at the distal end of the first electrode rod 112 and the first conductive portion 111 at the proximal end thereof are both located outside the second electrode rod 132 .
[0052] like Figure 3and Figure 6 As shown, a second insulating structure is provided on the outside of the second electrode rod 132. More specifically, the diameter of other parts of the second electrode rod 132 is smaller than the diameter of the second conductive portion 131. Therefore, the second insulating structure is sleeved on the outer surface of the second electrode rod 132, and the end of the second insulating structure can be abutted against the end (distal end) of the second conductive portion 131, and the outer diameter of the second insulating structure can be consistent with the outer diameter of the second conductive portion 131.
[0053] The second insulating structure may be, for example, a heat shrink tube, a polyimide (PI) tube, or an insulating coating, wherein the insulating coating may be a polyetheretherketone (PEEK) coating.
[0054] like Figure 3 As shown, the distal end of the second electrode rod 132 is provided with a lead terminal B. For example, the exposed portion of the distal end of the second electrode rod 132 is not covered by the second insulating structure, and thus can be connected to the lead 5 as a high voltage input terminal.
[0055] Lead terminal A and lead terminal B are respectively connected to lead 5, which can be connected to the high-voltage output device of the pulse ablation device through lead 5 and the connector to input electrical energy, so that high-voltage (for example, above 400V / cm) discharge can be performed between the first conductive part 111 and the second conductive part 131, thereby realizing irreversible electroporation ablation.
[0056] like Figure 3 As shown, the first conductive part 111 is located outside the second conductive part 131, and the first conductive part 111 and the second conductive part 131 are separated in the axial direction by the isolating member 12. That is, the first electrode rod 112 penetrates the second electrode rod 132 and the second conductive part 131, and the first conductive part 111 is located outside the second conductive part 131, and a discharge gap is formed between the two. The isolating member 12 is located between the first conductive part 111 and the second conductive part 131.
[0057] like Figure 5 As shown, the isolating member 12 is constructed as an insulating ring sleeved on the first electrode rod 112, and the insulating ring is located between the first conductive portion 111 and the second conductive portion 131, and its length may be, for example, 1 mm to 20 mm. The isolating member 12 may be made of, for example, polyimide or polyetheretherketone.
[0058] Therefore, it can be understood that the first electrode rod 112 passes through the second electrode rod 132, and its diameter can be slightly smaller than the inner diameter of the second electrode rod 132, and the lead terminal A at its distal end extends from the distal end of the second electrode rod 132, and the first conductive portion 111 at its proximal end is located on the outside of the second conductive portion 131 at the proximal end of the second electrode rod 132, so the outer diameters of the first conductive portion 111 and the second conductive portion 131 can be the same, and the isolating member 12 can be sleeved on the first electrode rod 112 to ensure the insulation between the first conductive portion 111 and the second conductive portion 131, so the outer diameter of the isolating member 12 can be the same as the outer diameters of the first conductive portion 111 and the second conductive portion 131.
[0059] That is to say, after the first electrode assembly 11 is inserted into the second electrode assembly 13, the outer diameter of the second insulating structure, the outer diameter of the second conductive part 131, the outer diameter of the isolation part 12 and the outer diameter of the first conductive part 111 are the same, that is, the needle rod assembly 1 forms a uniform outer diameter to reduce the difficulty of puncture and reduce the puncture resistance.
[0060] Resin glue may be filled between the first electrode rod 112 and the second electrode rod 132 , and the first electrode rod 112 and the second electrode rod 132 may be fixed after the resin glue is solidified.
[0061] Please continue to see Figure 1 and 2 The handle assembly 2 can be an integrated or split structure. Figure 2 As shown, the handle assembly 2 is a split structure, which includes a handle upper shell 25 and a handle lower shell 24, which are connected by various known connection methods such as positioning pins, bolts, buckles, etc. The split structure of the handle assembly 2 is more convenient for assembly operation.
[0062] like Figure 2 and Figure 7 As shown, the proximal side of the handle assembly 2 is provided with an end cap 21, the interior of the handle assembly 2 is provided with a fixing cylinder 22, and the distal end of the needle bar assembly 1 passes through the end cap 21 and the fixing cylinder 22 in sequence, thereby being fixed in the handle assembly 2. Therefore, the end cap 21 and the fixing cylinder 22 can play a role in supporting and fixing the needle bar assembly 1.
[0063] like Figure 2 and Figure 8 As shown, a first slot 27 is provided on the inner wall of the handle assembly 2 , and a snap ring 211 is provided on the circumference of the end cover 21 . The snap ring 211 is connected to the first slot 27 , so that the end cover 21 can be fixed to the proximal side of the handle assembly 2 .
[0064] It can be understood that since the handle assembly 2 is a split structure, the first slot 27 can also be a split structure, that is, Figure 2As shown, a part is respectively provided on the handle upper shell 25 and the handle lower shell 24, and the two are buckled together to form a complete first slot 27. Alternatively, a complete first slot 27 can be provided on one of the handle upper shell 25 and the handle lower shell 24.
[0065] like Figure 2 As shown, a plurality of second slots 26 are provided on the inner wall of the handle assembly 2, and each second slot 26 is connected to the fixing tube 22, thereby fixing it in the handle assembly 2 to prevent the needle rod assembly from sliding during puncture. Fig.11 As shown, the outer diameters of the fixing tubes 22 are not the same, and the outer diameter of the middle portion 221 is smaller than the outer diameters of the two end portions, so the inner diameter of the second slot 26 at the corresponding position on the inner wall of the handle assembly 2 is also smaller (e.g. Figure 1 As shown), the fixing cylinder 22 is more reliably fixed inside the handle assembly 2.
[0066] It can be understood that since the handle assembly 2 is a split structure, the second slot 26 on the inner wall thereof can be a split structure, that is, Figure 2 As shown, a part is respectively provided on the handle upper shell 25 and the handle lower shell 24, and the two are buckled together to form a complete second slot 26. Alternatively, a complete second slot 26 can be provided on one of the handle upper shell 25 and the handle lower shell 24.
[0067] like Figure 2 As shown, the handle assembly 2 is provided with a third slot at the distal end, and the LED light board 3 can be provided in the third slot at the distal end of the handle assembly 2, so that the installation is more convenient. The LED light board 3 can display the operating status of the multi-electrode ablation needle through different colors. Figure 2 As shown, since the handle assembly 2 is a split structure, the third slot can also be a split structure, or a complete third slot can be provided on one of the handle upper shell 25 and the handle lower shell 24 .
[0068] The distal end of the handle assembly 2 is also provided with a threading hole 23 for passing the lead wire 5. Figure 1 and Figure 2 As shown, the lead wires 5 connected to the lead terminal A and the lead terminal B are respectively passed through the corresponding threading holes 23 to be connected to the connector. Similarly, the threading holes 23 can be constructed as a part of the handle upper shell 25 and the handle lower shell 24, as shown in FIG. Figure 2 As shown, when the two are buckled together, a complete threading hole 23 can be formed.
[0069] Example 2
[0070] like Figure 9-11 As shown, based on the above-mentioned embodiment 1, a variant embodiment is also provided.
[0071] The difference between the present embodiment 2 and the above-mentioned embodiment 1 is that the first electrode assembly 11 is entirely conductive. Fig.10 As shown, the first electrode rod 112 and the first conductive portion 111 disposed at the proximal end of the first electrode rod 112 can both be conductive. Therefore, accordingly, in order to ensure the insulation performance between the first electrode assembly 11 and the second electrode assembly 13, as shown in FIG. Fig.11 As shown, the isolating member 12 is configured to include an isolating tube 122 and an isolating portion 121 located at the proximal end of the isolating tube 122. Fig. 9 As shown, the isolation tube 122 is sleeved on the first electrode rod 112 and is located between the first electrode rod 112 and the second electrode rod 132 to ensure the insulation between the two. The isolation portion 121 is located between the first conductive portion 111 and the second conductive portion 131 to form a discharge gap between the two. The distal end of the isolation tube 122 does not cover the lead terminal A at the distal end of the first electrode rod 112 to ensure that it can conduct electricity.
[0072] Therefore, in the second embodiment, the separator 12 serves as both an insulating layer of the first electrode assembly 11 and a separator between the first electrode assembly 11 and the second electrode assembly 13 .
[0073] Resin glue can be filled between the first electrode rod 112 and the isolation tube 122 and between the isolation tube 122 and the second electrode rod 132 . After the resin glue is solidified, the first electrode rod 112 and the isolation tube 122 and the second electrode rod 132 of the isolation tube 122 can be fixed.
[0074] The similarities between this embodiment 2 and the above-mentioned embodiment 1 will not be repeated again.
[0075] Example 3
[0076] The utility model further provides a pulse ablation apparatus, comprising the multi-electrode ablation needle described in the above embodiments, and also comprising a high-voltage output device (not shown), which is connected to the multi-electrode ablation needle via a lead wire 5 and / or a connector.
[0077] The pulse ablation device of the present invention may also include other components for realizing its necessary functions, which may adopt various structural forms in the prior art, and the present invention will not elaborate on them.
[0078] In addition, in the present invention, “proximal end” refers to the side close to the tip 1111 , and distal end refers to the side away from the tip 1111 .
[0079] Although the present invention has been described with reference to preferred embodiments, various modifications may be made thereto and parts thereof may be replaced with equivalents without departing from the scope of the present invention. In particular, the various technical features mentioned in the various embodiments may be combined in any manner as long as there is no structural conflict. The present invention is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.
Claims
1. A multi-electrode ablation needle, characterized in that: The needle bar assembly (1) comprises at least two electrode assemblies, each electrode assembly being sequentially sleeved and connected from the inside to the outside. The innermost electrode assembly axially penetrates the outer electrode assembly, and the conductive part on the innermost electrode assembly extends out of the outer electrode assembly, and an isolation member (12) is provided between the conductive parts of each electrode assembly.
2. The multi-electrode ablation needle according to claim 1, characterized in that: The needle bar assembly (1) comprises: A first electrode assembly (11), comprising a first electrode rod (112) and a first conductive portion (111) arranged at a proximal end of the first electrode rod (112); and A second electrode assembly (13), comprising a second electrode rod (132) sleeved outside the first electrode rod (112), wherein a second conductive portion (131) is provided at a proximal end of the second electrode rod (132); The first conductive portion (111) is located outside the second conductive portion (131), and the first conductive portion (111) and the second conductive portion (131) are separated in the axial direction by the isolation member (12).
3. The multi-electrode ablation needle according to claim 2, characterized in that: A first insulating structure is provided on the outer surface of a portion of the first electrode rod (112) located in the second electrode rod (132); the isolating member (12) is constructed as an insulating ring sleeved on the first electrode rod (112); and the insulating ring is located between the first conductive portion (111) and the second conductive portion (131).
4. The multi-electrode ablation needle according to claim 2, characterized in that: The first electrode rod (112) is a conductive structure as a whole, and the isolation member (12) comprises an isolation tube (122) and an isolation portion (121) located at the proximal end of the isolation tube (122), the isolation tube (122) is located between the first electrode rod (112) and the second electrode rod (132), and the isolation portion (121) is located between the first conductive portion (111) and the second conductive portion (131).
5. The multi-electrode ablation needle according to claim 2, characterized in that: A second insulating structure is provided on the outer surface of the second electrode rod (132), and an end of the second insulating structure abuts against an end of the second conductive portion (131).
6. The multi-electrode ablation needle according to any one of claims 2 to 4, characterized in that: The distal end of the first electrode rod (112) is located outside the distal end of the second electrode rod (132), and the distal ends of the first electrode rod (112) and the second electrode rod (132) are both provided with lead terminals.
7. The multi-electrode ablation needle according to claim 2 or 3, characterized in that: The first conductive portion (111) is configured as a puncture needle tip.
8. The multi-electrode ablation needle according to any one of claims 1 to 4, characterized in that: It also includes a handle assembly (2) which is arranged in an integrated or split manner, wherein the proximal side of the handle assembly (2) is provided with an end cover (21), the interior of the handle assembly (2) is provided with a fixing cylinder (22), and the distal end of the needle rod assembly (1) passes through the end cover (21) and the fixing cylinder (22) in sequence.
9. The multi-electrode ablation needle according to claim 8, characterized in that: The distal end side of the handle assembly (2) is also provided with an LED light board (3) and a threading hole (23).
10. A pulse ablation apparatus, comprising the multi-electrode ablation needle according to any one of claims 1 to 9, characterized in that: It also includes a high-voltage output device, which is connected to the multi-electrode ablation needle through a lead wire and / or a connector.