Ablation electrode and manufacturing method thereof

Abstract

The present invention relates to the field of manufacturing interventional medical products, in particular to an ablation electrode and a method for manufacturing the same. The main outer sheath adapter of the existing nickel-titanium electrode used for ablation surgery increases the outer diameter, places high demands on the space of the interventional catheter, and is not suitable for small-sized interventional catheters. To this end, the present invention provides an ablation electrode and a method for manufacturing the same, comprising a tubular nickel-titanium electrode with two open ends and a wire for fixing the electrical connection. One end of the wire is inserted into the lumen of the nickel-titanium electrode, and the insulating sheath is stripped off at the insertion end to expose part of the wire core. The wire core is clamped and fixed to the inner wall of the lumen of the nickel-titanium electrode by a connector. The connector is formed by solder that is melted and aggregated into a sphere with the assistance of flux and cooled. The present invention utilizes the solder on the wire core to be hot-melted and aggregated under the action of flux to cool and interfere with the nickel-titanium electrode wall, thereby achieving connection, fixation, and electrical connection between the nickel-titanium electrode and the wire. The outer diameter of the nickel-titanium electrode will not increase or become thicker, and it can be widely used in small-sized interventional catheters.

Description

Technical Field

[0001] The present invention relates to the field of manufacturing of interventional medical products, in particular to an ablation electrode and a manufacturing method thereof. Background Art

[0002] Interventional medical products typically include a main unit, an energy generator, and a consumable device similar to an interventional catheter. These two devices are electrically connected and used together to form an interventional system. Catheters typically utilize internally inserted ablation electrodes for energy transmission and treatment. The main portion of the ablation electrodes is typically made of nickel-titanium shape memory metal. While nickel-titanium electrodes are excellent for interventional applications, their high melting point makes them difficult to weld. Electrically connecting these nickel-titanium electrodes to the main unit via wires has long been a pressing technical challenge.

[0003] The current connection between the nickel-titanium electrode and the host is to first connect the nickel-titanium electrode with a wire, then connect the wire to the socket, and then connect the socket to the host through a cable. Since the nickel-titanium electrode is not easy to weld, the stability of the welding connection between the wire and the nickel-titanium electrode is poor. For this reason, an adapter is added to connect and fix the nickel-titanium electrode and the wire. This adapter is made of a material that is easy to weld. The connection structure is as follows Figure 1 As shown, the adapter 5 is connected to the nickel-titanium electrode 2 by crimping, and the wire 1 only needs to be welded to the adapter 5. The fixed position of the wire 1 on the adapter 2 is the welding point 6, which then electrically connects the socket and the wire, the adapter and the nickel-titanium electrode. This adapter transition structure can reliably connect the wire to the nickel-titanium electrode electrically, but it requires the interventional catheter of the consumable to have a large capacity space, not only to be able to pass the nickel-titanium electrode, but also to accommodate the connector crimped on the surface of the nickel-titanium electrode. For small consumables that intervene in smaller human cavities, such as small catheters used for interventional blood vessels and micro-bronchial cavities, since the outer diameter of the catheter itself is already very small, it cannot provide enough space to adapt to the aforementioned installation structure of adding an adapter to connect the nickel-titanium electrode. For catheters used for high-pressure ablation in human bronchi, the outer diameter of the catheter itself is already less than 2 mm, and there is not enough space inside the catheter to install the adapter to connect the nickel-titanium electrode and the wire. Summary of the Invention

[0004] The technical problems to be solved and the technical tasks proposed by the present invention are to address the technical problems that the existing nickel-titanium electrode must be electrically connected to the main unit through the installation structure of an additional adapter, which has high requirements on the space capacity of the interventional catheter and cannot be used on small-sized catheters such as interventional blood vessels and micro-bronchial cavities. The present invention provides an ablation electrode and a manufacturing method thereof. The manufacturing method can be used inside a small-sized catheter to achieve reliable electrical connection between the nickel-titanium electrode and the wire, solving the problem that the adapter is not suitable for connecting the nickel-titanium electrode to this type of small catheter. The outer diameter of the ablation electrode manufactured will not increase or become thicker, and the requirements on the space size of the interventional catheter are reduced.

[0005] The present invention solves the technical problem using a technical solution: a method for manufacturing an ablation electrode, comprising a wire with an insulating sheath and a tubular nickel-titanium electrode, wherein both ends of the nickel-titanium electrode are open, wherein the manufacturing method comprises processing the wire and the nickel-titanium electrode according to the following steps:

[0006] (1) Pass the wire through the lumen of the nickel-titanium electrode, and peel off part of the sheath at one end of the wire extending out of the lumen of the nickel-titanium electrode to expose part of the wire core;

[0007] (2) Solder the exposed front end of the wire core;

[0008] (3) Dip the soldering flux around the wire core after soldering;

[0009] (4) withdrawing the wire into the lumen of the nickel-titanium electrode so that the end of the wire core covered with solder and flux is withdrawn into the lumen of the nickel-titanium electrode;

[0010] (5) The end of the wire core where the solder and flux are located is continuously heated through the tube wall of the nickel-titanium electrode, and the solder is melted and aggregated into a sphere under the action of the flux;

[0011] (6) Stop heating, and after the sphere cools and solidifies, it will have an interference fit with the inner wall of the nickel-titanium electrode lumen, so that one end of the wire is clamped and fixed to the inner wall of the nickel-titanium electrode lumen.

[0012] The present invention inserts a wire into the lumen of the nickel-titanium electrode, and heats the exposed core of the wire where the wire is pre-stripped and tin and flux are added by external blowing heat, so that the solder is hot-melted and aggregated into a sphere under the action of the flux and then cooled. After cooling, the sphere has an interference fit with the tube wall of the nickel-titanium electrode, and one end of the wire is firmly clamped and fixed on the tube wall of the nickel-titanium electrode. This manufacturing method fully utilizes the internal lumen space of the nickel-titanium electrode, does not cause the outer diameter of the nickel-titanium electrode to become thicker, and does not affect the insertion and installation of the nickel-titanium electrode in the interventional catheter.

[0013] As a further improvement and supplement to the above technical solution, the present invention adopts the following technical measures: the conductor is an enameled wire with a copper core. Enameled wire is low-cost and readily available. The outer insulation layer of the enameled wire can be used as an insulating sheath. The inner copper core has good conductivity and is easy to solder. After the solder is melted and cools, it remains firmly connected to the copper core.

[0014] The heating is performed by blowing air from one side of the nickel-titanium electrode to the head of the wire core to which the solder and flux are added. The operation of the hot air gun is simple, and the time and temperature are easy to control.

[0015] The hot air gun's blowing temperature is 380°C ± 30°C, and the blowing time is 8 seconds ± 2 seconds. Maintaining the blowing temperature and blowing time within this range fully melts the solder and flux, allowing the flux to melt and aggregate the solder into a sphere. The heated flux evaporates, and the molten solder sphere cools to create an interference fit with the inner wall of the nickel-titanium electrode lumen, securing the wire within the nickel-titanium electrode lumen.

[0016] An ablation electrode comprises a tubular nickel-titanium electrode with open ends and a wire fixedly electrically connected thereto, wherein the wire consists of a conductive core and an insulating sheath surrounding the conductive core, one end of the wire is inserted into the lumen of the nickel-titanium electrode, and the inserted end of the wire is stripped of the insulating sheath to expose a portion of the wire core, and the wire core is clamped and fixed to the inner wall of the lumen of the nickel-titanium electrode by a connector, the connector being located between the wire core and the inner wall of the lumen of the nickel-titanium electrode, and the connector being a sphere formed by the fusion of solder in the aforementioned manufacturing method. The present invention provides an ablation electrode with a built-in fixing method. The wire of the ablation electrode is inserted into the lumen of the nickel-titanium electrode, and the sphere formed by soldering by heat melting under the action of flux is cooled and interference fits with the lumen of the nickel-titanium electrode, so that the wire is clamped and fixed on the nickel-titanium electrode. The ablation electrode does not require additional components to the outside of the nickel-titanium electrode, and the outer diameter of the nickel-titanium electrode will not increase or become thicker, thereby reducing the requirements of the entire ablation electrode on the inner cavity space size of the interventional catheter, and can be better adapted for use on small-diameter interventional catheters used for thin-diameter blood vessels and tiny bronchial cavities.

[0017] The present invention provides a simple and ingenious method for manufacturing an ablation electrode and an ablation electrode manufactured by the method, which solves the technical problems that there is insufficient space in the existing small catheter to install connectors for docking and fixing the nickel-titanium electrode and the wire, and that the nickel-titanium electrode and the wire are difficult to directly dock. The manufacturing method specifically involves stripping the solder and flux on the wire core of the wire passing through the nickel-titanium electrode, then pulling the wire back into the tube cavity of the nickel-titanium electrode and heating it through the tube wall. The flux causes the solder to melt and polymerize to form a sphere, which is then cooled and interference-fitted with the tube wall of the nickel-titanium electrode, so that the wire is clamped and fixed on the tube wall of the nickel-titanium electrode. The solder itself has good conductivity, which can simultaneously ensure effective electrical connection between the wire and the nickel-titanium electrode, and the outer diameter of the nickel-titanium electrode with the wire connected will not increase or become thicker. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 : Schematic diagram of the existing nickel-titanium electrode and wire docking fixation.

[0019] Figure 2 : Schematic diagram of soldering tin on the present invention.

[0020] Figure 3 : The schematic diagram of the present invention adding soldering flux.

[0021] Figure 4: Schematic diagram of heating the nickel-titanium electrode according to the present invention.

[0022] Figure 5 : Schematic diagram of the wire being fixed and clamped after heating and cooling according to the present invention.

[0023] In the figure: 1. Wire, 2. NiTi electrode, 3. Solder, 4. Flux, 5. Adapter, 6. Solder joint, 7. Sphere. DETAILED DESCRIPTION

[0024] The present invention will be further described below with reference to the accompanying drawings and specific embodiments.

[0025] The present invention includes an ablation electrode and a method for manufacturing the same. An example of a method for manufacturing an ablation electrode is provided. The ablation electrode includes a conductive wire 1 with an insulating sheath and a tubular nickel-titanium electrode 2. The conductive wire 1 is an enameled wire with a copper core, and the nickel-titanium electrode 2 has open ends. The method includes processing the conductive wire 1 and the nickel-titanium electrode according to the following steps:

[0026] (1) Pass the wire 1 through the lumen of the nickel-titanium electrode 2, and peel off part of the sheath at one end of the wire 1 extending out of the lumen of the nickel-titanium electrode 2 to expose part of the copper wire core;

[0027] (2) Solder 3 on the front end of the exposed wire core, such as Figure 2 The middle arrow indicates the step of tinning with a conventional soldering iron.

[0028] (3) Dip the soldering flux 4 around the wire core after soldering 3, as shown in the following example: Figure 3 The middle arrow points to adding flux 4, which is added outside the solder 3;

[0029] (4) withdrawing the wire 1 into the lumen of the nickel-titanium electrode 2 so that the wire core ends of the upper solder 3 and the flux 4 are withdrawn into the lumen of the nickel-titanium electrode;

[0030] (5) The end of the wire core where the solder and flux are located is continuously heated through the tube wall of the nickel-titanium electrode, such as Figure 4 As indicated by the middle arrow, a hot air gun is used to heat the end of the solder and flux wire core from one side of the nickel-titanium electrode. The hot air gun's blowing temperature is 380°C ± 30°C, and the blowing time is 8 seconds ± 2 seconds. In this embodiment, the preferred blowing temperature is 380°C and the blowing time is 8 seconds. Under the action of the flux, the solder is melted and aggregated into a sphere 7.

[0031] (6) Stop heating, such as Figure 5 That is, after the sphere 7 cools and solidifies, it has an interference fit with the inner wall of the nickel-titanium electrode 2 , so that one end of the wire 1 is clamped and fixed to the inner wall of the nickel-titanium electrode 2 .

[0032] In the manufacturing method described in the present invention, after the wire core is hot-melted with solder for the first time, the solder is relatively small and irregularly attached to the wire core. At this time, the wire core can be pulled back into the nickel-titanium electrode tube cavity normally. When heated by a hair dryer, the original solder gathers and melts to form a sphere with the assistance of flux. After cooling, the sphere can form an interference fit with the nickel-titanium electrode tube cavity, clamping the wire and the nickel-titanium electrode to complete the fixed connection between the two. The role of the flux here is to allow the solder to gather together and melt into a sphere so that it can be physically squeezed and clamped to the wire and the nickel-titanium electrode after cooling. The flux will evaporate after heating; the solder itself is conductive and can ensure effective electrical connection between the wire and the nickel-titanium electrode.

[0033] An ablation electrode manufactured by the aforementioned manufacturing method comprises a tubular nickel-titanium electrode 2 with open ends and a wire 1 fixedly electrically connected thereto. The wire 1 is a copper-core enameled wire consisting of an inner conductive copper wire core and an outer insulating sheath. One end of the wire 1 is inserted into the lumen of the nickel-titanium electrode 2, and the insulating sheath is stripped off at the inserted end to expose part of the copper wire core. The wire core is clamped and fixed to the inner wall of the lumen of the nickel-titanium electrode 2 by a connector. The connector is located between the copper core and the wall of the nickel-titanium electrode, and is formed by cooling a sphere formed by melting and gathering solder 3 with the assistance of flux 4.

[0034] The present invention provides an ablation electrode and a manufacturing method thereof. The manufacturing method sequentially applies solder and flux to the copper core stripped from the enameled wire, then heats the copper core with a hot air gun through the tube wall of the nickel-titanium electrode. The flux is used to heat the solder to form a sphere, which is then cooled. The solder has an interference fit with the tube wall of the nickel-titanium electrode, and the wire is clamped and fixed to the tube wall of the nickel-titanium electrode. The solder itself has good conductivity and can simultaneously ensure effective electrical connection between the wire and the nickel-titanium electrode, solving the problem that there is insufficient space in the existing small interventional catheter to install connectors to dock and fix the nickel-titanium electrode and the wire. The ablation electrode manufactured by this manufacturing method has good conductivity, and the wire of the ablation electrode and the nickel-titanium electrode are firmly connected. In addition, the brazing station, tin soldering wire, flux, and hot air gun required for applying solder in the aforementioned manufacturing method are all readily available conventional equipment. The manufactured ablation electrode can be connected to the nickel-titanium electrode and one end of the wire using a multimeter to detect conductivity, and the connection force between the nickel-titanium electrode and the wire can also be detected as needed to check the connection firmness.

Claims

1. A method for manufacturing an ablation electrode, comprising a wire with an insulating sheath and a tubular nickel-titanium electrode, wherein both ends of the nickel-titanium electrode are open, and wherein: The manufacturing method comprises processing the wire and the nickel-titanium electrode according to the following steps: (1) Pass the wire through the lumen of the nickel-titanium electrode, and peel off part of the sheath at one end of the wire extending out of the lumen of the nickel-titanium electrode to expose part of the wire core; (2) Solder the exposed front end of the wire core; (3) Dip the soldering flux around the wire core after soldering; (4) withdrawing the wire into the lumen of the nickel-titanium electrode so that the end of the wire core covered with solder and flux is withdrawn into the lumen of the nickel-titanium electrode; (5) The end of the wire core where the solder and flux are located is continuously heated through the tube wall of the nickel-titanium electrode, and the solder is melted and aggregated into a sphere under the action of the flux; (6) Stop heating, and after the sphere cools and solidifies, it will have an interference fit with the inner wall of the nickel-titanium electrode lumen, so that one end of the wire is clamped and fixed to the inner wall of the nickel-titanium electrode lumen.

2. The ablation electrode manufacturing method according to claim 1, characterized in that The conductor is an enameled wire with a copper core.

3. The ablation electrode manufacturing method according to claim 1, characterized in that The heating is performed by using a hot air gun to blow air from one side of the nickel-titanium electrode to heat the head of the wire core to which solder and flux are added.

4. The ablation electrode manufacturing method according to claim 3, characterized in that The blowing temperature of the hot air gun is 380° C.±30° C., and the blowing time is 8 seconds±2 seconds.

5. An ablation electrode manufactured according to the manufacturing method of any one of claims 1 to 4, comprising a tubular nickel-titanium electrode with open ends and a wire fixedly electrically connected thereto, the wire consisting of a conductive core and an insulating sheath surrounding the conductive core, one end of the wire being inserted into the lumen of the nickel-titanium electrode, and the inserted end of the wire being stripped of the insulating sheath to expose part of the wire core, the wire core being clamped and fixed to the inner wall of the lumen of the nickel-titanium electrode by a connector, the connector being located between the wire core and the inner wall of the lumen of the nickel-titanium electrode, and the connector being a sphere formed by the melting and aggregation of solder in the manufacturing method.

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