Electrode needle and ablation treatment device

Abstract

The invention provides an electrode needle and an ablation treatment device. The electrode needle comprises a needle head; the far end of the supporting assembly is connected with the near end of the needle in an inserted mode. The electrode piece is arranged on the peripheral wall of the far end of the supporting assembly in a sleeving mode, the far end of the electrode piece does not exceed the far end of the supporting assembly, and the electrode piece is made of platinum or platinum alloy; the first insulating layer wraps the peripheral wall of the near end of the supporting assembly and wraps at least part of the peripheral wall of the near end of the electrode piece. The electrode piece is arranged on the peripheral wall of the far end of the supporting assembly in a sleeving mode, the supporting assembly plays a role in supporting the electrode piece, and the electrode needle is prevented from being bent during operation such as puncture. Moreover, platinum belongs to inert metal, the electrode piece is made of platinum or platinum alloy, the thickness of the electrode piece is large, electrochemical corrosion of the electrode piece of the electrode needle in the ablation process can be avoided, and therefore harm to the human body is avoided.

Description

Technical Field

[0001] The present application relates to the technical field of minimally invasive surgery, and in particular, to an electrode needle and an ablation treatment device. Background Art

[0002] In the field of tumor treatment, according to the treatment principle, it can be divided into thermal ablation that causes cell thermal necrosis, cryoablation that causes cell low-temperature damage, pulsed electric field ablation that induces cell apoptosis, chemotherapy that changes the cell environment to destroy tumors, etc.; thermal ablation includes radiofrequency ablation, microwave ablation, etc.; chemotherapy includes electrolytic ablation, etc.

[0003] At present, the electrode needles used for electrolytic ablation need to have conductivity, biosafety, corrosion resistance, and certain strength and hardness. Although graphene meets the above conditions, it is not suitable for use as an electrode for an electrode needle because it is relatively brittle. Therefore, the electrode needle is usually made of platinum-iridium alloy, or is made by platinum-plating the surface of a needle rod made of heavy metal materials, such as stainless steel or titanium alloy. Due to the low strength of platinum, the electrode needle made of pure platinum is easy to bend during puncture and other operations, so platinum-iridium alloy is generally used to increase the strength, and the large-scale use of pure platinum and platinum-iridium alloy will result in high costs. In the case of a thinner diameter electrode needle, the plating layer of pure platinum or platinum alloy is easy to fall off, or even cannot be plated on the outer surface of the electrode needle, or the electrode needle made of platinum plated on the surface of heavy metal has a thin platinum layer, and the thickness of the plating layer on the surface of heavy metal is uneven, and the corrosion resistance of the electrode needle decreases, resulting in electrochemical corrosion between multiple electrode needles due to electrolysis during electrolytic ablation, causing the heavy metals of the needle rod to enter the human body in an ionic state, bringing toxic and harmful substances to the human body, and causing immeasurable harm to the human body. Summary of the invention

[0004] In view of the shortcomings of the existing methods, the present application proposes an electrode needle and an ablation treatment device to solve the technical problems in the related technology that electrode needles made of platinum are easy to bend during puncture and other operations and are costly, the electrode needle coating is easy to fall off or cannot be plated, or the electrode needle with platinum on the heavy metal surface will undergo electrochemical corrosion during the electrolytic ablation process, causing the heavy metal in the needle shaft to enter the human body in an ionic state and cause harm to the human body.

[0005] In a first aspect, an embodiment of the present application provides an electrode needle, comprising: Needles; A support assembly, the distal end of the support assembly being connected to the proximal end of the needle; An electrode member, sleeved on the outer peripheral wall of the distal end of the support assembly, wherein the distal end of the electrode member does not exceed the distal end of the support assembly, and the material of the electrode member includes: platinum or platinum alloy; The first insulating layer covers the outer peripheral wall of the proximal end of the support component and covers at least a portion of the outer peripheral wall of the proximal end of the electrode member.

[0006] Optionally, a first groove is provided at the center of the proximal end of the needle, a second annular concave groove is provided at the distal end of the support assembly, and the distal end of the support assembly is connected to the proximal end of the needle.

[0007] Optionally, the support assembly comprises: a first support body; A reinforcing tube, sleeved on the outer peripheral wall of the first supporting body; The second support body is sleeved on the outer peripheral wall of the reinforcement tube, and the diameter of the distal end of the second support body is smaller than the diameter of the proximal end of the second support body.

[0008] Optionally, the distal ends of the first support body and the second support body both extend beyond the distal end of the reinforcing tube, and the second groove is formed between the first support body and the second support body; the distal end of the electrode member does not extend beyond the distal end of the second support body.

[0009] Optionally, the needle tip is made of at least one of ceramic, plastic or carbon fiber; The second support is electrically conductive.

[0010] Optionally, the needle includes a first portion and a second portion distributed from the proximal end to the distal end; The distal end of the first portion is flush with the distal end of the second support body, and the first portion is disposed in the second groove; The first groove passes through the first part and stops at the proximal end of the second part, and the distal end of the first support body is disposed in the first groove.

[0011] Optionally, the electrode needle further includes an insulating member; The insulating member is sleeved on the outer peripheral wall of the first support body close to the distal end, the distal end of the insulating member is fixedly connected to the proximal end of the needle, and the proximal end of the insulating member is plugged into the second groove.

[0012] Optionally, the radial dimension of the distal end of the insulating member is greater than the radial dimension of the proximal end of the insulating member.

[0013] Optionally, the material of the needle includes: platinum or platinum alloy; The first support is capable of conducting electricity; The distal end of the first support body is inserted into the first groove at the proximal end of the needle.

[0014] Optionally, the support assembly further comprises a second insulating layer; The second insulating layer is sleeved on the outer peripheral wall close to the distal end of the first supporting body, the insulating member is sleeved on the outer peripheral wall at the distal end of the second insulating layer, and the distal end of the insulating member does not exceed the distal end of the second insulating layer.

[0015] Optionally, the electrode needle further includes an injection portion; the injection portion is disposed in the first groove at the proximal end of the needle head, and the proximal end of the injection portion is connected to the distal end of the first support body.

[0016] Optionally, the first support body is a metal tubular structure.

[0017] In a second aspect, an embodiment of the present application provides an ablation treatment device, comprising: an external device and an electrode needle as described in any one of the first aspects above; The proximal end of the electrode needle is fixed in the external device, and the proximal end of the electrode needle is electrically connected to the external device.

[0018] The beneficial technical effects brought about by the technical solution provided by the embodiment of the present application include: The electrode needle provided in the embodiment of the present application has a proximal end of the needle connected to the distal end of the support assembly, and the electrode part is sleeved on the outer peripheral wall of the distal end of the support assembly. The support assembly supports the electrode part, which can enhance the rigidity of the electrode needle and prevent the electrode needle from bending during puncture and other operations. The electrode part is made of platinum or platinum alloy. Since the amount of platinum or platinum alloy in the electrode part is less than that in the electrode needle made entirely of platinum and platinum alloy, medical costs are saved.

[0019] Moreover, platinum is an inert metal, and platinum or platinum alloy is used to manufacture the electrode parts. The thickness of the electrode parts is relatively thick, which can prevent the electrode parts of the electrode needle from electrochemical corrosion during the electrolytic ablation process, thereby preventing harm to the human body. In addition, a first insulating layer is sleeved on the outer peripheral wall of the proximal end of the support component and the outer peripheral wall of the proximal end of the electrode part to isolate the support component from contact with the external environment, thereby preventing the support component from electrochemical corrosion during the electrolytic ablation process, and also preventing the exposed part of the support component from conducting electricity and causing electric shock hazards.

[0020] Additional aspects and advantages of the present application will be partially given in the following description, which will become apparent from the following description, or will be understood through the practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The above and / or additional aspects and advantages of the present application will become apparent and easily understood from the following description of the embodiments in conjunction with the accompanying drawings, in which: Figure 1 A schematic diagram of the structure of a treatment device including a monopolar electrode needle provided in an embodiment of the present application; Figure 2A schematic diagram of the structure of a treatment device including bipolar electrode needles provided in an embodiment of the present application; Figure 3 A schematic front view of a treatment device including a monopolar electrode needle or a bipolar electrode needle provided in an embodiment of the present application; Figure 4 for Figure 3 Schematic diagram of the cross section along AA (BB); Figure 5 When the electrode needle of the embodiment of the present application is a monopolar electrode needle, Figure 4 A local enlarged schematic diagram of the middle A; Figure 6 for Figure 5 Structural schematic diagram of the corresponding supporting structure; Figure 7 for Figure 5 Schematic diagram of the structure of the corresponding needle; Figure 8 When the electrode needle of the embodiment of the present application is a bipolar electrode needle, Figure 4 A partial enlarged schematic diagram of point B in the middle; Fig. 9 for Figure 8 Structural schematic diagram of the corresponding supporting structure; Fig.10 A schematic diagram of the structure of a treatment device including an irrigation electrode needle provided in an embodiment of the present application; Fig.11 A schematic front view of a treatment device including an irrigation electrode needle provided in an embodiment of the present application; Fig.12 for Fig.11 Schematic diagram of the cross section along CC; Fig.13 for Fig.12 A partial enlarged schematic diagram of point C in the middle. Reference numerals: 1-Electrode needle; 11-needle; 111-first groove; 112-first part of the needle; 113-second part of the needle; 12-support assembly; 121-second groove; 122-first support body; 123-reinforcement tube; 124-second support body; 125-second insulation layer; 13-electrode member; 14-first insulating layer; 15-insulating member; 16-injection part; 161-infusion hole; 2- External devices. DETAILED DESCRIPTION

[0022] The embodiments of the present application are described below in conjunction with the drawings in the present application. It should be understood that the implementation methods described below in conjunction with the drawings are exemplary descriptions for explaining the technical solutions of the embodiments of the present application and do not constitute a limitation on the technical solutions of the embodiments of the present application.

[0023] Those skilled in the art will appreciate that, unless expressly stated, the "said" and "the" used herein may also include plural forms. It should be further understood that the term "including" used in the specification of the present application refers to the presence of the features, integers, steps, operations, elements and / or components, but does not exclude the implementation of other features, information, data, steps, operations, elements, components and / or combinations thereof supported by the technical field. The term "and / or" used herein refers to at least one of the items defined by the term, for example, "A and / or B" may be implemented as "A", or as "B", or as "A and B".

[0024] In order to make the objectives, technical solutions and advantages of the present application clearer, the implementation methods of the present application will be further described in detail below with reference to the accompanying drawings.

[0025] In the field of tumor treatment, according to the treatment principle, it can be divided into thermal ablation that causes cell thermal necrosis, cryoablation that causes cell low-temperature damage, pulsed electric field ablation that induces cell apoptosis, chemotherapy that changes the cell environment to destroy tumors, etc.; thermal ablation includes radiofrequency ablation, microwave ablation, etc.; chemotherapy includes electrolytic ablation, etc.

[0026] Radiofrequency ablation uses radiofrequency current to cause changes in the electromagnetic field, causing the positive and negative ions in the cells to rub and collide with other particles, producing a biothermal effect; microwave ablation uses the microwave magnetic field to make the surrounding molecules rotate at high speed and heat up due to friction, causing the proteins in tumor cells to coagulate and denature, resulting in irreversible necrosis.

[0027] Cryoablation forms ice balls by releasing cold energy, freezing tumor cells at extremely low temperatures and then thawing them. The temperature step changes can effectively cause physical necrosis or metabolic damage to the tumor. It is a technology that has less impact on patients and less burden on their bodies.

[0028] Pulsed electric field ablation applies extremely strong high-voltage electric pulses to tissues within an extremely short time (milliseconds, microseconds, or even nanoseconds), causing irreversible electroporation on the cell membrane and leading to cell death.

[0029] Electrolytic ablation is a process in which the cathode and anode are placed in an electrolyte environment and then energized, causing a redox reaction at the two electrodes. This process changes the pH value of the tumor to form a cytotoxic environment, completely destroying the tumor cells in the area.

[0030] During electrolytic ablation, the electrodes will produce new substances through redox reactions. These substances may be harmful to the human body. In order to prevent harmful substances from damaging the human body, specific inert metals such as platinum are usually used as electrodes.

[0031] At present, the electrode needles used for electrolytic ablation are usually made of platinum, or platinum is plated on the surface of the needle rod made of heavy metal materials, such as stainless steel or titanium alloy. Due to the low strength of platinum, the electrode needle made of platinum is easy to bend during puncture and other operations, and the large-scale use of platinum will lead to increased medical costs. The electrode needle made of platinum plated on the surface of heavy metal has a thin platinum layer and uneven thickness of the coating on the surface of heavy metal, resulting in electrochemical corrosion between multiple electrode needles due to electrolysis during the electrolytic ablation process, causing the heavy metals in the needle rod to enter the human body in an ionic state, bringing toxic and harmful substances to the human body, causing immeasurable harm to the human body, especially when stainless steel is used to make the needle rod. The chromium ions in stainless steel are class III carcinogens, which are more harmful to the human body.

[0032] The following is a detailed description of the technical solution of the present application and how the technical solution of the present application solves the above technical problems with specific embodiments. It should be noted that the following implementations can refer to, draw on or combine with each other, and the same terms, similar features and similar implementation steps in different implementations will not be described repeatedly.

[0033] First, several terms involved in the present application are introduced and explained: in the present application, the proximal end refers to the end of the electrode needle 1 that is closer to the device operator when the device is in use, and the distal end refers to the end of the electrode needle 1 that is farther away from the device operator when the device is in use.

[0034] The present application embodiment provides an electrode needle 1, such as Figure 1-13 As shown, the electrode needle 1 includes: a needle head 11, a support assembly 12, an electrode member 13, and a first insulating layer 14.

[0035] The support component 12 has a distal end that is plugged into the proximal end of the needle 11 .

[0036] The electrode member 13 is sleeved on the outer peripheral wall of the distal end of the support component 12. The distal end of the electrode member 13 does not exceed the distal end of the support component 12. The material of the electrode member 13 includes: platinum or platinum alloy.

[0037] The first insulating layer 14 covers the outer peripheral wall of the proximal end of the supporting component 12 and covers at least a portion of the outer peripheral wall of the proximal end of the electrode member 13 .

[0038] The electrode needle 1 provided in the embodiment of the present application has a proximal end of the needle 11 connected to the distal end of the support component 12, and the electrode component 13 is sleeved on the outer peripheral wall of the distal end of the support component 12. The support component 12 supports the electrode component 13, thereby enhancing the rigidity of the electrode needle 1 and preventing the electrode needle 1 from bending during puncture and other operations. The electrode component 13 is made of platinum or platinum alloy. Since the amount of platinum or platinum alloy in the electrode component 13 is less than that in the electrode needle 1 made entirely of platinum and platinum alloy, medical costs are saved.

[0039] Moreover, platinum is an inert metal, and platinum or a platinum alloy is used to manufacture the electrode component 13. The thickness of the electrode component 13 is relatively thick, far exceeding the thickness of the platinum plating on the electrode needle, which can effectively prevent the electrode component 13 of the electrode needle 1 from electrochemical corrosion during the electrolytic ablation process, thereby preventing harm to the human body.

[0040] In addition, a first insulating layer 14 is provided on the outer peripheral wall of the proximal end of the support component 12 and the outer peripheral wall of the proximal end of the electrode component 13 to isolate the support component 12 from the external environment, thereby avoiding electrochemical corrosion of the support component 12 during the electrolytic ablation process, preventing the exposed part of the support component from conducting electricity and causing the risk of electric shock, and also avoiding electric spark discharge between the support component 12 and the electrode component 13.

[0041] Optionally, in one embodiment of the present application, Figure 5-7 , Figure 8-9 and Fig.13 As shown, a first groove 111 is provided at the center of the proximal end of the needle 11 , and an annular concave second groove 121 is provided at the distal end of the support component 12 , and the distal end of the support component 12 is connected to the proximal end of the needle 11 .

[0042] In the embodiment of the present application, the proximal end of the needle 11 is provided with a first groove 111, and the distal end of the support assembly 12 is provided with a second annular concave groove 121, so that the proximal end of the needle 11 can be embedded in the second groove 121 at the distal end of the support assembly 12, and the central part of the distal end of the support assembly 12 can be embedded in the first groove 111 of the needle 11, so that the connection between the needle 11 and the support assembly 12 is more firm, and the connection reliability between the needle 11 and the support assembly 12 is enhanced; and the proximal end of the needle 11 can also be supported by the support assembly 12, so as to avoid the contact surface connecting the needle 11 and the support assembly 12 from being disconnected. It should be noted that the connection method between the needle 11 and the support assembly 12 can be various.

[0043] Optionally, in one embodiment of the present application, Figure 5-6 , Figure 8-9 and Fig.13 As shown, the support assembly 12 includes: a first support body 122 , a reinforcement tube 123 and a second support body 124 .

[0044] The reinforcing tube 123 is sleeved on the outer peripheral wall of the first supporting body 122 .

[0045] The second support body 124 is sleeved on the outer peripheral wall of the reinforcing tube 123 , and the diameter of the distal end of the second support body 124 is smaller than the diameter of the proximal end of the second support body 124 .

[0046] In the embodiment of the present application, the reinforcing tube 123 and the second support body 124 are sequentially sleeved on the outer peripheral wall of the first support body 122, and the diameter of the distal end of the second support body 124 is smaller than the diameter of the proximal end of the second support body 124, so that the second support body 124 has a step due to the diameter change, and the electrode component 13 is sleeved on the outer peripheral wall of the area with a smaller diameter at the distal end of the second support body 124, and the proximal end of the electrode component 13 contacts the step on the outer peripheral wall of the second support body 124, so that the step on the outer peripheral wall of the second support body 124 can fix the electrode component 13 and prevent the electrode component 13 from moving along the outer peripheral wall of the second support body 124.

[0047] Optionally, in one embodiment of the present application, Figure 5-6 , Figure 8-9 and Fig.13 As shown, The distal ends of the first support body 122 and the second support body 124 both extend beyond the distal end of the reinforcing tube 123 to form a second groove 121 ; the distal end of the electrode member 13 does not extend beyond the distal end of the second support body 124 .

[0048] In the embodiment of the present application, the distal ends of the first support body 122 and the second support body 124 both extend beyond the distal end of the reinforcing tube 123, thereby forming an annular concave second groove 121 between the outer circumferential wall at the distal end of the first support body 122 and the inner circumferential wall at the distal end of the second support body 124. Moreover, the distal end of the electrode member 13 is arranged not to extend beyond the distal end of the second support body 124, so that the support assembly 12 can support the electrode member 13, thereby improving the rigidity of the electrode needle 1.

[0049] Optionally, in one embodiment of the present application, Figure 5 , Figure 7 and Fig.13 As shown, the material of the needle 11 includes at least one of ceramic, plastic or carbon fiber.

[0050] The second support body 124 can conduct electricity.

[0051] In the embodiment of the present application, the material of the needle 11 is selected from ceramics, plastics, carbon fiber or other materials with similar properties. Since the chemical properties of materials such as ceramics, plastics or carbon fiber are stable and non-conductive, electrochemical corrosion will not occur during the electrolytic ablation process, thereby avoiding the production of toxic and harmful substances entering the human body and causing no harm to the human body; moreover, materials such as ceramics, plastics or carbon fiber have high strength, which can improve the puncture performance of the electrode needle 1.

[0052] In the embodiment of the present application, the second support 124 is conductive, the electrode member 13 is electrically connected to the second support 124 , and the second support 124 is electrically connected to an external device, so that the second support 124 can provide electrical energy transmission for the electrode member 13 .

[0053] Optionally, in one embodiment of the present application, Figure 5 , Figure 7 and Fig.13 As shown, the needle 1 comprises a first portion 112 and a second portion 113 extending from the proximal end to the distal end.

[0054] The distal end of the first portion 112 is flush with the distal end of the second support body 124 , and the first portion 112 is inserted into the second groove 121 .

[0055] The first groove 111 penetrates through the first portion 112 and stops at the proximal end of the second portion 113 . The distal end of the first support body 122 is inserted into the first groove 111 .

[0056] In the embodiment of the present application, along the direction from the proximal end to the distal end of the needle 11, the size of the first groove 111 is larger than the size of the first part 112, the first part 112 is inserted in the second groove 121 formed between the outer peripheral wall of the first support body 122 and the inner peripheral wall of the second support body 124, and the distal end of the first support body 122 is inserted in the first groove 111, thereby realizing the connection between the needle 11 and the support assembly 12.

[0057] It should be noted that Figure 5 and Figure 7 In the figure, the line between the first portion 112 and the second portion 113 of the needle 11 is only used to distinguish the areas to which the first portion 112 and the second portion 113 belong, and does not actually exist.

[0058] Optionally, in a specific embodiment of the present application, Figure 1 and Figure 3-7As shown, the electrode needle 1 is a monopolar electrode needle 1, and the first support body 122 of the support assembly 12 of the monopolar electrode needle 1 includes a stainless steel wire, etc., the reinforcing tube 123 is sleeved on the outer peripheral wall of the first support body 122, and the second support body 124 includes a stainless steel tube, the second support body 124 is sleeved on the outer peripheral wall of the reinforcing tube 123, the diameter of the distal end of the second support body 124 is smaller than the diameter of the proximal end of the second support body 124, the electrode member 13 is sleeved on the outer peripheral wall of the second support body 124, and is located in the area with a smaller diameter at the distal end of the second support body 124, the electrode member 13 includes a platinum tube, so that the second support body 124 can support the electrode member 13, thereby enhancing the strength of the monopolar electrode needle 1 and preventing the monopolar electrode needle 1 from bending during puncture and other operations; and the electrode member 13 adopts a platinum tube, the amount of platinum used is small, the cost can be saved, and the manufacturing process of the platinum tube is simple.

[0059] In the monopolar electrode needle 1, the first support 122 can be made of a conductive material or an insulating material; the second support 124 is made of a conductive material. When the first support 122 is made of a conductive material, the first support 122 can be electrically connected to an external device, the first support 122 can be electrically connected to the second support 124, and the second support 124 can be electrically connected to the electrode member 13, so that the electric energy is transmitted to the electrode member 13 via the first support 122 and the second support 124 in sequence, or the second support 124 can be directly electrically connected to an external device, and the second support 124 can be electrically connected to the electrode member 13, so that the electric energy is transmitted to the electrode member 13 via the second support 124. When the first support 122 is made of an insulating material, the second support 124 can be electrically connected to an external device, and the electrode member 13 can be electrically connected to the second support 124, so that the second support 124 can provide electric energy transmission for the electrode member 13. During electrolytic ablation, two monopolar electrode needles work together, one as an anode and the other as a cathode, to achieve the purpose of electrolytic ablation.

[0060] The first insulating layer 14 of the monopolar electrode needle 1 is on the outer peripheral wall of the proximal end of the support component 12 and the outer peripheral wall of the proximal end of the electrode member 13, so that the first insulating layer 14 can isolate the second support body 124 such as a stainless steel tube from contact with the external electrolyte, avoid electrochemical corrosion of the second support body 124, prevent the exposed part of the support component from conducting electricity and causing the risk of electric shock, and also avoid electric spark discharge between the support component 12 and the electrode member 13.

[0061] The first part 112 of the needle 11 of the monopolar electrode needle 1 is inserted into the second groove 121 formed between the outer peripheral wall of the first support body 122 and the inner peripheral wall of the second support body 124. The distal end of the first support body 122 is inserted into the first groove 111 at the proximal center of the needle to achieve transitional fit between the needle 11 and the support assembly 12. The needle 11 is made of ceramic, plastic carbon fiber or other materials with similar properties. Since the chemical properties of materials such as ceramic, plastic or carbon fiber are stable and non-conductive, the needle 11 will not be electrochemically corroded during the electrolytic ablation process, thereby avoiding the generation of toxic and harmful substances entering the human body, and thus will not cause harm to the human body; and materials such as ceramic, plastic or carbon fiber are high in strength, which can improve the puncture performance of the electrode needle 1. The distal end of the needle 11 includes a triangular structure, which is convenient for puncture operations when the needle 11 contacts the tissue.

[0062] Optionally, in one embodiment of the present application, Figure 8-9 As shown, the electrode needle 1 further includes an insulating member 15 .

[0063] The insulating member 15 is sleeved on the outer peripheral wall of the first support body 122 near the distal end. The distal end of the insulating member 15 is fixedly connected to the proximal end of the needle 11 , and the proximal end of the insulating member 15 is plugged into the second groove 121 .

[0064] In the embodiment of the present application, the insulating member 15 is sleeved on the outer peripheral wall of the first support body 122 near the distal end, the proximal end of the insulating member 15 is plugged into the second groove 121, and the distal end of the insulating member 15 is fixedly connected to the proximal end of the needle 11, so that the insulating member 15 separates the electrode member 13 and the needle 11. When the needle 11 is also used as an electrode, the insulating member 15 can isolate the adverse interference between the electrode member 13 and the needle 11.

[0065] Optionally, in one embodiment of the present application, Figure 8-9 As shown, the radial dimension of the distal end of the insulating member 15 is greater than the radial dimension of the proximal end of the insulating member 15 .

[0066] In the embodiment of the present application, the diameter of the proximal end of the insulating member 15 is smaller than the diameter of the distal end of the insulating member 15, and a step is formed on the outer peripheral wall of the insulating member 15. The proximal end of the insulating member 15 is plugged into the second groove 121, and the distal end of the insulating member 15 is fixedly connected to the proximal end of the needle 11. The second support body 124 and the electrode member 13 are sequentially arranged in the area with a smaller diameter at the proximal end of the insulating member 15. The step on the outer peripheral wall of the insulating member 15 can fix the second support body 124 and the electrode member 13 to prevent the electrode member 13 from moving along the outer peripheral wall of the insulating member 15.

[0067] Optionally, in one embodiment of the present application, Figure 8-9 As shown, the material of the needle 11 includes: platinum or platinum alloy.

[0068] The first support body 122 can conduct electricity.

[0069] The distal end of the first support body 122 is inserted into the first groove 111 at the proximal end of the needle 11 .

[0070] In the embodiment of the present application, the distal end of the first support body 122 extends beyond the distal end of the insulating member 15, and the distal end of the first support body 122 is inserted into the first groove 111 of the needle 11. The first support body 122 is conductive, and the needle 11 made of platinum or platinum alloy is electrically connected to the first support body 122, so that the first support body 122 can transmit electrical energy to the needle 11, and the first support body 122 can support the needle 11, thereby enhancing the strength of the needle 11 and facilitating the puncture operation of the needle 11.

[0071] Optionally, in one embodiment of the present application, Figure 8-9 As shown, the support assembly 12 further includes a second insulating layer 125 .

[0072] The second insulating layer 125 is sleeved on the outer peripheral wall near the distal end of the first support 122, and the insulating member 15 is sleeved on the outer peripheral wall of the distal end of the second insulating layer 125, and the distal end of the insulating member 15 does not exceed the distal end of the second insulating layer 125. A short circuit between the first support 122 and the second support 124 is avoided.

[0073] In the embodiment of the present application, the distal end of the second insulating layer 125 is fixedly connected to the proximal end of the needle 11 , the insulating member 15 is sleeved on the outer peripheral wall of the distal end of the second insulating layer 125 , and the distal end of the insulating member 15 is fixedly connected to the proximal end of the needle 11 .

[0074] Optionally, in a specific embodiment of the present application, Figure 2-4 and Figure 8-9 As shown, the electrode needle 1 is a bipolar electrode needle 1, and the first support body 122 of the support assembly 12 of the bipolar electrode needle includes stainless steel wire, etc., the second insulating layer 125 and the reinforcing tube 123 are sequentially sleeved on the outer peripheral wall of the first support body 122, the second support body 124 includes a stainless steel tube, the second support body 124 is sleeved on the outer peripheral wall of the reinforcing tube 123, the insulating member 15 is sleeved on the outer peripheral wall of the second insulating layer 125 near the distal end, the proximal end of the insulating member 15 is plugged into the second groove 121, the distal ends of the second insulating layer 125 and the insulating member 15 are both fixedly connected to the proximal end of the needle 11, the distal end of the first support body 122 is inserted into the first groove 111 of the needle 11, the needle 11 is made of platinum or platinum alloy, the first support body 122 is made of conductive material, the first support body 122 is electrically connected to an external device, and the needle 11 is electrically connected to the first support body 122, so that the first support body 122 can transmit electrical energy to the needle 11.

[0075] The electrode member 13 is sleeved on the outer peripheral wall of the second support body 124, so that the support assembly 12 can enhance the strength of the bipolar electrode needle 1, and the electrode member 13 adopts a platinum tube or a platinum alloy tube, and the manufacturing process of the platinum tube or the platinum alloy tube is simple. The second support body 124 is made of a conductive material, the second support body 124 is electrically connected to an external device, and the electrode member 13 is electrically connected to the second support body 124, so that the second support body 124 can provide electrical energy transmission for the electrode member 13.

[0076] The diameter of the distal end of the second support body 124 is smaller than the diameter of the proximal end of the second support body 124, and is located in the area where the diameter of the distal end of the second support body 124 is smaller. The step of the second support body 124 can fix the proximal end of the electrode member 13. The diameter of the proximal end of the insulating member 15 is smaller than the diameter of the distal end of the insulating member 15. The outer peripheral wall of the insulating member 15 forms a step. The proximal end of the insulating member 15 is plugged into the second groove 121, and the distal end of the insulating member 15 is fixedly connected to the proximal end of the needle 11. The second support body 124 and the electrode member 13 are sequentially sleeved in the area with smaller diameter at the proximal end of the insulating member 15. The step of the outer peripheral wall of the insulating member 15 can fix the second support body 124 and the electrode member 13, and the insulation 15 separates the electrode member 13 and the needle 11. When the needle 11 is also used as an electrode, the insulating member 15 can isolate the adverse interference between the electrode member 13 and the needle 11.

[0077] The first insulating layer 14 of the bipolar electrode needle 1 is on the outer peripheral wall of the proximal end of the support assembly 12 and the outer peripheral wall of the proximal end of the electrode member 13, so that the first insulating layer 14 can isolate the second support body 124 such as a stainless steel tube from contact with the external electrolyte, thereby preventing the second support body 124 from electrochemical corrosion.

[0078] In addition, in the bipolar electrode needle 1 of the present embodiment, the first support body 122 is electrically connected to the needle head 11, and the second support body 124 is electrically connected to the electrode member 13. The two electrodes use different circuits, so that the bipolar electrode needle 1 can use a single needle for electrolysis ablation, and the treatment range is more precisely controllable, thereby improving the treatment efficiency and treatment effect, and compared with multi-needle treatment, the patient's pain is reduced.

[0079] During electrolytic ablation, the first support body 122 of the bipolar electrode needle 1 transmits electrical energy to the needle head 11, and the second support body 124 of the bipolar electrode needle 1 transmits electrical energy to the electrode member 13. One of the needle head 11 and the electrode member 13 of the bipolar electrode needle 1 acts as a cathode, and the other acts as an anode, thereby achieving the purpose of electrolytic ablation.

[0080] Optionally, in one embodiment of the present application, Fig.13 As shown, the electrode needle 1 further includes an injection portion 16 ; the injection portion 16 is disposed in the first groove 111 at the proximal end of the needle head 11 , and the proximal end of the injection portion 16 is communicated with the distal end of the first support body 122 .

[0081] In the embodiment of the present application, the injection part 16 is disposed in the first groove 111 at the proximal end of the needle 11, and the peripheral wall of the injection part 16 is provided with an infusion hole 161, and the corresponding position of the needle 11 is also provided with a through hole, so that the medicine or hypertonic solution in the injection part 16 can be injected into the target tissue area from the infusion hole 161 on the peripheral wall of the injection part 16 and the through hole of the needle 11, achieving the effect of auxiliary treatment. The hypertonic solution in the injection part 16 includes a sodium chloride solution.

[0082] Optionally, in the embodiment of the present application, the electrode needle 1 may not have the first support body 122, and the support assembly 12 only includes the reinforcement tube 123 and the second support body 124. The interior of the reinforcement tube 123 is a hollow structure, and the distal end of the hollow structure is connected to the proximal end of the injection part 16, and the proximal end of the hollow structure is connected to an external drug source. The drug source can be a drug storage tank, thereby forming a perfusion system. According to the condition of the lesion, drugs or hypertonic solutions can be injected into the target tissue area through the built-in perfusion system to achieve the effect of auxiliary treatment, wherein the hypertonic solution can increase the electrolyte concentration, improve the conductivity, and enhance the electrolysis effect.

[0083] Optionally, in one embodiment of the present application, Fig.13 As shown, the first support body 122 is a metal tubular structure.

[0084] In the embodiment of the present application, the first support body 122 is a metal tubular structure, the proximal end of the injection part 16 is connected to the distal end of the first support body 122, and a pipeline is provided inside the first support body 122, one end of the pipeline is connected to the injection part 16, and the other end of the pipeline is connected to an external drug source, which can be a drug storage tank, thereby forming a perfusion system. According to the condition of the lesion, drugs or hypertonic solutions can be injected into the target tissue area through the built-in perfusion system to achieve the effect of auxiliary treatment.

[0085] Optionally, in a specific embodiment of the present application, Figure 10-13As shown, the electrode needle 1 is an irrigated electrode needle 1, and the first support body 122 of the support assembly 12 of the irrigated electrode needle includes a stainless steel tube, etc., the reinforcing tube 123 is sleeved on the outer peripheral wall of the first support body 122, and the second support body 124 includes a stainless steel tube, the second support body 124 is sleeved on the outer peripheral wall of the reinforcing tube 123, the diameter of the distal end of the second support body 124 is smaller than the diameter of the proximal end of the second support body 124, the electrode member 13 is sleeved on the outer peripheral wall of the second support body 124, and is located in the area with a smaller diameter at the distal end of the second support body 124, the electrode member 13 includes a platinum tube or a platinum-iridium alloy tube, so that the second support body 124 can support the electrode member 13, thereby enhancing the strength of the irrigated electrode needle 1 and avoiding bending of the irrigated electrode needle 1 during puncture and other operations; and the electrode member 13 adopts a platinum tube or a platinum-iridium alloy tube, the amount of platinum or platinum-iridium alloy tube is small, which can save costs, and the manufacturing process of the platinum tube or the platinum-iridium alloy tube is simple. The second support body 124 is conductive, and is electrically connected to an external device. The electrode member 13 is electrically connected to the second support body 124 , so that the second support body 124 can provide electrical energy transmission for the electrode member 13 .

[0086] The injection part 16 of the perfusion electrode needle 1 is arranged in the first groove 111 at the proximal end of the needle 11, and a pipeline is arranged inside the first support body 122, one end of the pipeline is connected to the injection part 16, and the other end of the pipeline is connected to an external drug source, which can be a drug storage tank, thereby forming a perfusion system. According to the condition of the lesion, the drug or hypertonic solution can be injected into the target tissue area through the infusion hole 161 on the peripheral wall of the injection part 16 and the through hole on the needle 11 corresponding to the position of the infusion hole 161, thereby achieving the effect of auxiliary treatment.

[0087] The first insulating layer 14 of the perfusion electrode needle 1 is on the outer peripheral wall of the proximal end of the support component 12 and the outer peripheral wall of the proximal end of the electrode member 13, so that the first insulating layer 14 can isolate the second support body 124 such as a stainless steel tube from contact with the external electrolyte, thereby avoiding electrochemical corrosion of the second support body 124.

[0088] The first part 112 of the needle 11 of the perfusion electrode needle 1 is inserted into the second groove 121 formed between the outer peripheral wall of the first support body 122 and the inner peripheral wall of the second support body 124. The distal end of the first support body 122 is inserted into the first groove 111 at the proximal center of the needle 11 to achieve transitional cooperation between the needle 11 and the support assembly 12. The first support body 122 is non-conductive. The needle 11 is made of ceramic, plastic carbon fiber or other materials with similar properties. Since the chemical properties of ceramic, plastic or carbon fiber are stable and non-conductive, electrochemical corrosion will not occur during the electrolytic ablation process, thereby avoiding the generation of toxic and harmful substances entering the human body, and thus will not cause harm to the human body; and ceramic, plastic or carbon fiber and other materials have high strength, which can improve the puncture performance of the electrode needle 1. The distal end of the needle 11 includes a triangular structure, which is convenient for puncture when the needle 11 contacts the tissue.

[0089] It should be noted that Fig.13 In the figure, the line between the first portion 112 and the second portion 113 of the needle 11 is only used to distinguish the areas to which the first portion 112 and the second portion 113 belong, and does not actually exist.

[0090] Optionally, in an embodiment of the present application, the perfusion electrode needle 1 may not have the first support body 122, and the support assembly 12 only includes a reinforcing tube 123 and a second support body 124. The interior of the reinforcing tube 123 is a hollow structure, and the distal end of the hollow structure is connected to the proximal end of the injection part 16, and the proximal end of the hollow structure is connected to an external drug source, which may be a drug storage tank, thereby forming a perfusion system. Depending on the condition of the lesion, drugs or hypertonic solutions can be injected into the target tissue area through the built-in perfusion system to achieve an auxiliary treatment effect.

[0091] Based on the same inventive concept, the present application embodiment provides an ablation treatment device, such as Figure 1-2 and Fig.10 As shown, the ablation treatment device includes: an external device 2 and the electrode needle 1 of the above embodiment.

[0092] The proximal end of the electrode needle 1 is fixed in the external device 2 , and the proximal end of the electrode needle 1 is electrically connected to the external device 2 .

[0093] In the embodiment of the present application, the proximal end of the electrode needle 1 is electrically connected to an external device, so that the electrode needle 1 is controlled by the external device to perform ablation.

[0094] Optionally, the ablation treatment device of the present application is used for electrolytic ablation. In the treatment of tumors, a synergistic scheme of ablation energy and electrolysis can be adopted to enhance the treatment effect.

[0095] By applying the embodiments of the present application, at least the following beneficial effects can be achieved: 1. In the electrode needle 1 provided in the embodiment of the present application, the proximal end of the needle 11 is connected to the distal end of the support assembly 12, and the electrode member 13 is sleeved on the outer peripheral wall of the distal end of the support assembly 12. The support assembly 12 supports the electrode member 13, thereby enhancing the rigidity of the electrode needle 1 and preventing the electrode needle 1 from bending during puncture and other operations. The electrode member 13 is made of platinum or platinum alloy. Since the amount of platinum or platinum alloy in the electrode member 13 is less than that in the electrode needle 1 made entirely of platinum and platinum alloy, medical costs are saved.

[0096] Moreover, platinum is an inert metal, and platinum or platinum alloy is used to manufacture the electrode member 13. The thickness of the electrode member 13 is relatively thick, far exceeding the thickness of the platinum plated on the electrode needle, which can effectively prevent the electrode member 13 of the electrode needle 1 from electrochemical corrosion during the electrolytic ablation process, thereby not causing harm to the human body. In addition, a first insulating layer 14 is sleeved on the outer peripheral wall of the proximal end of the support component 12 and the outer peripheral wall of the proximal end of the electrode member 13 to isolate the support component 12 from the external environment, thereby avoiding electrochemical corrosion of the support component 12 during the electrolytic ablation process, preventing the exposed part of the support component from conducting electricity and causing electric shock, and also preventing electric spark discharge between the support component 12 and the electrode member 13.

[0097] Those skilled in the art will appreciate that the various operations, methods, steps, measures, and schemes in the processes discussed in this application may be alternated, changed, combined, or deleted. Furthermore, other steps, measures, and schemes in the various operations, methods, and processes discussed in this application may also be alternated, changed, rearranged, decomposed, combined, or deleted. Furthermore, steps, measures, and schemes in the related art that are similar to those disclosed in this application may also be alternated, changed, rearranged, decomposed, combined, or deleted.

[0098] In the description of the present application, the directions or positional relationships indicated by words such as "center", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside" and "outside" are based on the exemplary directions or positional relationships shown in the accompanying drawings. They are for the convenience of describing or simplifying the description of the embodiments of the present application, and do not indicate or imply that the referred device or component must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be understood as limitations on the present application.

[0099] The terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, unless otherwise specified, "plurality" means two or more.

[0100] In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0101] In the description of this specification, specific features, structures, materials or characteristics may be combined in an appropriate manner in any one or more embodiments or examples.

[0102] The above is only a partial implementation method of the present application. It should be pointed out that for ordinary technicians in this technical field, without departing from the technical concept of the scheme of the present application, other similar implementation methods based on the technical ideas of the present application are also within the protection scope of the embodiments of the present application.

Claims

1. An electrode needle, characterized in that: include: Needles; A support assembly, the distal end of the support assembly being connected to the proximal end of the needle; An electrode member, sleeved on the outer peripheral wall of the distal end of the support assembly, wherein the distal end of the electrode member does not exceed the distal end of the support assembly, and the material of the electrode member includes: platinum or platinum alloy; The first insulating layer covers the outer peripheral wall of the proximal end of the support component and covers at least a portion of the outer peripheral wall of the proximal end of the electrode member.

2. The electrode needle according to claim 1, characterized in that: A first groove is arranged at the center of the proximal end of the needle, a second annular concave groove is arranged at the distal end of the support component, and the distal end of the support component is connected to the proximal end of the needle.

3. The electrode needle according to claim 2, characterized in that: The support assembly comprises: a first support body; A reinforcing tube, sleeved on the outer peripheral wall of the first supporting body; The second support body is sleeved on the outer peripheral wall of the reinforcement tube, and the diameter of the distal end of the second support body is smaller than the diameter of the proximal end of the second support body.

4. The electrode needle according to claim 3, characterized in that: The distal ends of the first support body and the second support body both extend beyond the distal end of the reinforcing tube, and the second groove is formed between the first support body and the second support body; the distal end of the electrode member does not extend beyond the distal end of the second support body.

5. The electrode needle according to claim 4, characterized in that: The material of the needle includes: at least one of ceramic, plastic or carbon fiber; The second support is electrically conductive.

6. The electrode needle according to claim 5, characterized in that: The needle includes a first portion and a second portion distributed from the proximal end to the distal end; The distal end of the first portion is flush with the distal end of the second support body, and the first portion is disposed in the second groove; The first groove passes through the first part and stops at the proximal end of the second part, and the distal end of the first support body is disposed in the first groove.

7. The electrode needle according to claim 4, characterized in that: The electrode needle also includes an insulating member; The insulating member is sleeved on the outer peripheral wall of the first support body close to the distal end, the distal end of the insulating member is fixedly connected to the proximal end of the needle, and the proximal end of the insulating member is plugged into the second groove.

8. The electrode needle according to claim 7, characterized in that: The radial dimension of the distal end of the insulating member is greater than the radial dimension of the proximal end of the insulating member.

9. The electrode needle according to claim 7, characterized in that: The material of the needle includes: platinum or platinum alloy; The first support is capable of conducting electricity; The distal end of the first support body is inserted into the first groove at the proximal end of the needle.

10. The electrode needle according to claim 7, characterized in that: The support assembly also includes a second insulating layer; The second insulating layer is sleeved on the outer peripheral wall close to the distal end of the first supporting body, the insulating member is sleeved on the outer peripheral wall at the distal end of the second insulating layer, and the distal end of the insulating member does not exceed the distal end of the second insulating layer.

11. The electrode needle according to claim 5, characterized in that: The electrode needle further includes an injection portion; the injection portion is disposed in the first groove at the proximal end of the needle head, and the proximal end of the injection portion is communicated with the distal end of the first support body.

12. The electrode needle according to claim 11, characterized in that: The first support body is a metal tubular structure.

13. An ablation treatment device, characterized in that: include: An external device and an electrode needle as described in any one of claims 1 to 12 above; The proximal end of the electrode needle is fixed in the external device, and the proximal end of the electrode needle is electrically connected to the external device.

Images