Electrosurgical electrodes and applications thereof

Abstract

The invention relates to an electrosurgical electrode and application thereof.The electrosurgical electrode comprises an electrode base body and an anti-tissue-adhesion nanometer coating, the anti-tissue-adhesion nanometer coating covers at least part of the area of the surface of the electrode base body, the electrode base body contains tungsten-based high-specific-gravity alloy, the anti-tissue-adhesion nanometer coating is a polymer coating, and the surface of the electrode base body is coated with the anti-tissue-adhesion nanometer coating. And the thickness of the anti-tissue adhesion nano coating is 1-5 [mu] m. According to the electrosurgical electrode, the electrode base body and the anti-tissue-adhesion nanometer coating are compounded to obtain the electrode base body with excellent conductivity, adhesion of the electrode to tissue can be reduced, meanwhile, the arc ablation resistance of the electrode can be improved, the problem that a traditional high-frequency electrotome stainless steel electrode is prone to ablation after being used for a long time is solved, and the service life of the electrode is prolonged. And the use performance of the high-frequency electrotome is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of electrosurgical instruments, and particularly to an electrosurgical electrode and its application. Background Art

[0002] As a representative of electrosurgical energy instruments, the high-frequency electrotome is widely used in clinical surgical operations due to its advantages such as fast cutting speed, good hemostatic effect, and wound sterilization.

[0003] The working electrode material of traditional high-frequency electrotomes usually uses medical stainless steel, and its melting point is about 1370 - 1400°C. A large amount of heat will be generated at the tip of the electrotome pen in the high-frequency circuit, and the local tissue temperature is usually between 200 - 300°C.

[0004] When the high-frequency electrotome cuts body tissues clinically, the tissue cells burst and vaporize due to the thermal effect. The vaporized tissue particles adhere to the surface of the surgical electrode, forming an adhesive tissue layer that is difficult to remove. The adhesive tissue not only increases the resistance of the surgical electrode, makes it "blunt", reduces the cutting efficiency, but also makes the surgical electrode thicker, obscures the surgical field of view, reduces the surgical operation precision and surgical effect, increases the surgical pain suffered by the patient, and has an adverse impact on the patient's postoperative recovery.

[0005] Therefore, how to reduce tissue adhesion is a difficulty in improving the performance of high-frequency electrotomes. Summary of the Invention

[0006] Based on this, it is necessary to provide an electrosurgical electrode and its application to reduce tissue adhesion and thereby improve the performance of high-frequency electrotomes.

[0007] The first object of the present application is to provide an electrosurgical electrode, including an electrode substrate and an anti-tissue adhesion nano-coating. The anti-tissue adhesion nano-coating covers at least a partial area of the surface of the electrode substrate. Among them, the electrode substrate contains a tungsten-based high-density alloy, the anti-tissue adhesion nano-coating is a polymer nano-coating, and the thickness of the anti-tissue adhesion nano-coating is 1 - 5μm.

[0008] The present application creatively uses a tungsten-based high-density alloy to prepare the electrode substrate, and composites the electrode substrate with a conductive anti-tissue adhesion nano-coating to prepare an electrosurgical electrode with excellent conductivity, which can reduce the adhesion of the electrode to tissues, and at the same time improve the arc ablation resistance performance of the electrode, and solve the problem that the stainless steel electrode of traditional high-frequency electrotomes is prone to ablation during long-term use.

[0009] In one of the embodiments, the electrosurgical electrode satisfies at least one of the following characteristics (1) - (4):

[0010] (1) The resistance of the electrosurgical electrode is 0.10Ω - 0.20Ω;

[0011] (2) The electrosurgical electrode is a T-shaped electrode or an I-shaped electrode;

[0012] (3) The electrosurgical electrode has a through-hole with a diameter of 0.12 to 0.35 mm; optionally, the through-hole is a stepped hole;

[0013] (4) The electrosurgical electrode further includes a color-developing coating that covers at least a partial area of the surface of the electrode substrate, and an anti-tissue adhesion nano-coating is covered on the color-developing coating.

[0014] In one embodiment, the tungsten-based high specific gravity alloy is a WNiCu or WNiFe alloy or a tungsten-based high specific gravity alloy with a density greater than 17.0 kg / m 3 of.

[0015] In one embodiment, based on the total mass of the electrode substrate, the content of Ni in the electrode substrate is 1% to 7%, the content of Cu is 0.5% to 3%, and the content of W is the balance, wherein the mass ratio of Ni to Cu is 3:2 to 4:1; or,

[0016] the content of Ni in the electrode substrate is 1% to 7%, the content of Fe is 1% to 3%, and the content of W is the balance, wherein the mass ratio of Ni to Fe is 1:1 to 4:1; or,

[0017] the content of W in the electrode substrate is 80% to 99%, wherein the balance is the content of rare earth element RE or one or more metal elements of Co, Mo, and Cr.

[0018] In one embodiment, the coating of the electrosurgical electrode satisfies at least one of the following characteristics (1) to (5):

[0019] (1) The anti-tissue adhesion nano-coating is a thermal spray coating, a cold spray coating, a supersonic cold spray coating, an electroless plating coating, or a chemical vapor deposition coating;

[0020] (2) The color-developing coating is a CVD or PVD coating;

[0021] (3) The anti-tissue adhesion nano-coating is selected from a PTFE coating or a nickel fluoron coating;

[0022] (4) The color-developing coating includes at least one of a TiN coating, a Cr-N-Si coating, and a TiO coating;

[0023] (5) The thickness of the color-developing coating is 0.5 to 2.5 μm.

[0024] The second object of the present application is to provide the application of the above electrosurgical electrode in the preparation of an electrosurgical energy device.

[0025] The third object of the present application is to provide an electrosurgical energy device including the above electrosurgical electrode.

[0026] In one embodiment, the electrosurgical energy instrument includes a high-frequency electrotome.

[0027] The fourth object of the present application is to provide a method for preparing the above-mentioned electrosurgical electrode, including:

[0028] Preparing an electrode substrate with a tungsten-based high-density alloy;

[0029] Preparing an anti-tissue adhesion nano-coating on at least a partial area of the surface of the electrode substrate.

[0030] In one embodiment, before preparing the anti-tissue adhesion nano-coating on at least a partial area of the surface of the electrode substrate, it further includes:

[0031] Preparing a color-developing coating on the surface of the corresponding area of the electrode substrate and the anti-tissue adhesion nano-coating, so that the anti-tissue adhesion coating covers the color-developing coating. Description of the Drawings

[0032] In order to more clearly illustrate the specific embodiments of the present application or the technical solutions in the prior art, the following will briefly introduce the drawings required for use in the description of the specific embodiments or the prior art. Obviously, the following drawings are some embodiments of the present application. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0033] Figure 1 It is a schematic diagram of a T-shaped electrosurgical electrode in one embodiment. Figure 1 In (A), it represents the external schematic diagram of the T-shaped electrosurgical electrode. Figure 1 In (B), it represents the internal structure schematic diagram of the T-shaped electrosurgical electrode;

[0034] Figure 2 It is a schematic diagram of an I-shaped electrosurgical electrode in one embodiment. Figure 2 In (A), it represents the external schematic diagram of the I-shaped electrosurgical electrode. Figure 2 In (B), it represents the internal structure schematic diagram of the I-shaped electrosurgical electrode;

[0035] Figure 3 It is a preparation flow chart of the electrosurgical electrode provided in one embodiment;

[0036] Figure 4 It is a schematic diagram of the original surface electrode and the nickel-iron fluoron-coated electrode provided in one embodiment;

[0037] Figure 5 It is a preparation flow chart of the anti-tissue adhesion nano-coating provided in one embodiment;

[0038] Figure 6Flow chart for preparing a color-developing coating provided for an embodiment;

[0039] Figure 7 Schematic diagrams of three color-developing coatings provided for an embodiment;

[0040] Figure 8 Detection results of the anti-tissue adhesion performance of a high-frequency electrosurgical knife and its control provided for an embodiment. Detailed implementation manners

[0041] To facilitate the understanding of the present invention, the present invention will be described more comprehensively below with reference to the relevant drawings. Preferred embodiments of the present invention are shown in the drawings. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, these embodiments are provided to make the understanding of the disclosure of the present invention more thorough and comprehensive.

[0042] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field to which the present invention belongs. The terms used herein in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0043] During traditional electrosurgical procedures, high-frequency electrosurgical knives often use PTFE (Teflon) coated electrodes with low surface energy as anti-adhesion surgical electrodes. However, the cutting efficiency of PTFE coated electrodes is negatively correlated with the anti-adhesion ability. At the initial stage of cutting, the PTFE coating on the electrode surface is completely coated, and the anti-tissue adhesion effect is obvious, with less thermal damage to the tissue, but the cutting resistance is large and the cutting efficiency is low; as the cutting time increases, the PTFE coating becomes thinner and is locally ablated and penetrated by the arc, the cutting resistance is significantly reduced, but the anti-adhesion performance of the electrode drops sharply, and the thermal damage to the tissue increases; as the cutting time continues to increase, the PTFE coating is completely damaged, the anti-adhesion effect is lost, and the cutting resistance drops to the lowest value. Increasing the output power of the high-frequency electrosurgical knife can improve the cutting efficiency of the PTFE coated anti-adhesion surgical electrode, but the coating damage is aggravated, the effective anti-adhesion time of the coating is shortened, and the tissue damage is also significantly aggravated.

[0044] To solve the above technical problems, a first aspect of the present application provides an electrosurgical electrode, including an electrode substrate and an anti-tissue adhesion nano-coating, the anti-tissue adhesion nano-coating covering at least a partial area of the surface of the electrode substrate, wherein, the electrode substrate contains a tungsten-based high specific gravity alloy, the anti-tissue adhesion nano-coating is a polymer nano-coating, and the thickness of the anti-tissue adhesion nano-coating is 1 - 5 μm. It can be understood that the area covered by the anti-tissue adhesion nano-coating is preferably the area in contact with the tissue during the operation of the electrode.

[0045] In this application, the term "nano - coating" refers to a coating with a thickness of no more than 1 - 100 nanometers, which is an ultra - thin layer or chemical structure constructed on the surface of a substrate through various methods.

[0046] "Anti - adhesion nano - coating" refers to a nano - coating with the function of anti - tissue adhesion. Generally, anti - adhesion nano - coatings are mostly polymer nano - coatings.

[0047] In this application, the anti - adhesion nano - coating is used in combination with an electrode substrate containing tungsten - based high - density alloy to form an electrosurgical electrode. To make the electrode have good electrical conductivity, the thickness of the anti - adhesion nano - coating is 1 - 5μm.

[0048] This application creatively uses tungsten - based high - density alloy to prepare the electrode substrate, and combines the electrode substrate containing tungsten - based high - density alloy with an anti - adhesion nano - coating to prepare an electrosurgical electrode with excellent electrical conductivity. Among them, the tungsten - based high - density alloy has excellent electrical conductivity and high - temperature resistance, which can improve the arc - erosion resistance of the electrode. The anti - adhesion nano - coating is a polymer nano - coating, which can reduce the adhesion of the electrode to tissues and reduce tissue damage caused by the electrode.

[0049] In addition, the surface of the electrode substrate has a certain roughness. The anti - adhesion nano - coating fills the concave parts on the surface of the substrate, but the peaks on the surface of the electrode substrate are not covered by the anti - adhesion nano - coating. When the electrode is in use, it can conduct electricity through the convex surface of the electrode substrate itself, retaining the excellent electrical conductivity of the electrode substrate itself, thus solving the problem of poor arc - erosion resistance of the electrode.

[0050] Specifically, tungsten - based high - density alloys (Tungsten heavy alloys (WHAs)) are a type of tungsten - based alloys (with a tungsten content of 80% - 99%) and are added with a small amount of elements such as Ni, Cu, Fe, Co, Mo, Cr, etc. They are also called tungsten heavy alloys or high - density tungsten alloys, including but not limited to tungsten - copper, tungsten - molybdenum, and tungsten - nickel - iron alloys, etc. Tungsten - based high - density alloys have the characteristics of high - temperature resistance, arc - erosion resistance, and high density. In some specific embodiments, the tungsten - based high - density alloy is a WNiCu alloy, a WNiFe alloy, or a tungsten - based high - density alloy with a density greater than 17.0 kg / m 3 of the tungsten - based high - density alloy.

[0051] The WNiCu alloy is a high - temperature - resistant alloy with W as the matrix, a content of 80% - 99%, and the balance being a Ni - Cu solid solution as the bonding phase. It has the advantages of high strength, high hardness, good ductility, good machinability, small thermal expansion coefficient, large thermal conductivity, good oxidation and corrosion resistance, etc.

[0052] Compared with pure tungsten, in the WNiCu alloy, Ni and Cu act as binding phases, forming a limited Ni-W solid solution and an infinite Cu-Ni solid solution, which improves the strength, plasticity, and toughness of the alloy. Compared with pure tungsten materials, the WNiCu alloy has better machining performance, especially in precision machining.

[0053] When the WNiCu alloy is used as the material for the electrode substrate, Cu can absorb a large amount of arc energy through evaporation under the action of the high temperature of the arc, thereby reducing the arc temperature, reducing the electro-erosion effect, and improving the service environment of the electrode. In addition, Cu further improves the electrical conductivity of the material and can improve the cutting performance of the high-frequency electrosurgical unit.

[0054] In some specific embodiments, based on the total mass of the electrode substrate, the content of Ni in the electrode substrate is 1% - 7%, the content of Cu is 0.5% - 3%, and the content of W is 90% - 95%. Among them, the mass ratio of Ni:Cu is (3 - 4):(1 - 2).

[0055] The W-Ni-Fe alloy is formed by mixing, pressing, and sintering W, Ni, and Fe powders. Among them, the content of tungsten is the highest, reaching 80% - 90%, while Ni and Fe act as binders. After liquid-phase sintering, a two-phase alloy is formed, and the density is close to the theoretical density. Ni is an essential element in the liquid-phase sintering process, generally with a content of 0.5% - 12%. If it is greater than 12%, the heat resistance and corrosion resistance of the alloy will both decrease. The content of Fe is generally between 0.5% - 8%. If it is greater than 8%, the brittleness of the alloy will increase. Fe can improve the strength and plasticity in this alloy. This type of alloy has certain magnetism, and its strength and plasticity are both better than those of the W-Ni-Cu alloy.

[0056] In some specific embodiments, based on the total mass of the electrode substrate, the content of Ni in the electrode substrate is 1% - 7%, the content of Fe is 1% - 3%, and the content of W is the balance. Among them, the mass ratio of Ni and Fe is 1:1 - 4:1.

[0057] In some specific embodiments, based on the total mass of the electrode substrate, the content of W in the electrode substrate is 80% - 99%, and the balance is the content of rare earth element RE or one or more metal elements among Co, Mo, and Cr.

[0058] For example, for the W-Ni-Co alloy, the Co element acts as a co-strengthening additive element in this alloy, which can improve the high-temperature performance of the alloy, especially strengthen the binding phase, avoid the formation of intermetallic compounds, and significantly improve the high-temperature strength and hardness of the alloy. The general content is 0.5% - 5%. Research shows that when the temperature is higher than 500 degrees Celsius, the strength and plasticity of this alloy are significantly higher than those of the W-Ni-Fe alloy.

[0059] In some specific embodiments, the electrode substrate is a T-shaped electrode structure or an I-shaped electrode structure.

[0060] In some embodiments, the electrode substrate has a through-hole with a diameter of 0.12 - 0.35 mm, and liquid injection operations can be carried out through the through-hole during surgical procedures.

[0061] In some specific embodiments, the through-hole is a stepped hole. A stepped hole, that is, a series of holes with different specifications distributed on the same axis, is also called a stepped borehole, and is generally produced during the drilling process. During the production process, it is necessary to first drill a through-hole with a drill bit and then drill a semi-through-hole.

[0062] In this application, after the electrode substrate containing tungsten-based high-density alloy and the thin anti-tissue adhesion nano-coating are combined, the resistance of the electrosurgical electrode can be 0.10 Ω - 0.20 Ω, having excellent electrical conductivity.

[0063] In some embodiments, the anti-tissue adhesion nano-coating is selected from a Teflon coating or a nickel-Teflon coating. Polytetrafluoroethylene (PTFE) has the lowest friction coefficient and surface energy, a service temperature as high as 250 °C, is resistant to corrosion by strong oxidants, is insoluble in strong acids, strong alkalis and organic solvents, has a long aging life, and has physiological inertness. The nickel-Teflon coating is a coating in which PTFE particles are randomly distributed in the Ni-P matrix. This coating not only retains the non-adhesion effect of PTFE but also has the good electrical conductivity of Ni metal.

[0064] In some embodiments, in order to obtain the anti-tissue adhesion nano-coating with the above thickness, by way of example, the anti-tissue adhesion nano-coating is a supersonic cold spray coating, electroless plating or chemical vapor deposition coating. It can be understood that in this application, the spraying method of the anti-tissue adhesion nano-coating can be arbitrary, as long as a nano-coating with anti-tissue adhesion effect can be obtained and the electrode substrate can maintain excellent electrical conductivity.

[0065] Specifically, the electroless plating coating is obtained by adding PTFE particles to the electroless nickel plating solution, and finally a coating in which the particles are randomly distributed in the Ni-P matrix is obtained, so that this coating not only retains the non-adhesion effect of PTFE but also has the good electrical conductivity of Ni metal.

[0066] In some specific embodiments, in order to make the electrode have good electrical conductivity, the thickness of the electroless plating coating is 3 - 5 μm.

[0067] Chemical vapor deposition (CVD) coating is formed by depositing a solid thin film on the substrate surface through a gas-phase chemical reaction. Chemical vapor deposition is a thin film process, in which the deposited substances are usually atoms, molecules or a combination of both.

[0068] In some specific embodiments, in order to make the electrode have good electrical conductivity, the thickness of the chemical vapor deposition coating is 1 - 3 μm.

[0069] The supersonic cold spray coating refers to a dense coating formed by shooting coating powder onto a substrate by a supersonic gas-solid two-phase flow at normal temperature or a relatively low temperature.

[0070] In some specific embodiments, in order to make the electrode have good electrical conductivity, the thickness of the supersonic cold spray coating is 3 - 5 μm.

[0071] It should be noted that for the anti-adhesion coating prepared by the traditional dip coating method, due to the relatively thick coating, the electrode substrate will be completely insulated, resulting in the electrode resistance exceeding the range. In this application, a supersonic cold spray coating with a nano-thickness is creatively prepared on the surface of the electrode substrate, which improves the electrical conductivity of the high-frequency electrotome and at the same time enhances the anti-tissue adhesion performance of the high-frequency electrotome.

[0072] In addition, during the clinical electrocision surgery of the high-frequency electrotome, this process belongs to an intermittent on-off discharge process. Therefore, the surface of the electrode will be subjected to an intermittent thermal stress cycle. Due to the difference in the thermal expansion coefficients of the coating and the substrate, the coating will be damaged and peeled off, losing the protection of the substrate and not perfectly achieving the characteristics of the coating itself. Since the spraying particles of the supersonic spray coating exceed the speed of sound, the outstanding advantage of this coating is its high bonding strength with the electrode substrate and low porosity. The wear resistance, corrosion resistance and high-temperature resistance of the coating will also be further improved. The supersonic cold spray coating not only has excellent coating performance but also low spraying cost.

[0073] In some embodiments, the electrosurgical electrode further includes a color display coating, the color display coating covers at least a part of the surface of the electrode substrate, and the anti-tissue adhesion nano-coating covers the color display coating. A highly dense and high bonding strength color display coating on the surface of the electrode substrate is beneficial to improving the surface activity, wear resistance and arc ablation resistance of the electrode substrate. At the same time, the color display coating with different colors can make the electrode have rich colors, improve the recognition rate of the electrode during the surgical operation, and reduce the visual fatigue of the electrode operator.

[0074] In some specific embodiments, the thickness of the color display coating is 0.5 - 2.5 μm, further it can be 1 - 2.5 μm, and still further it can be 1.5 - 2.5 μm.

[0075] In some specific embodiments, the color - developing coating is a CVD coating or a PVD coating. PVD (Physical Vapour Deposition) is a purely physical nano - scale thin - film deposition process, which can prepare a highly dense and high - bonding - strength color - developing coating on the surface of the electrode substrate. Chemical Vapor Deposition (CVD) is a thin - film process in which a solid thin - film is deposited on the substrate surface due to gas - phase chemical reactions, and the deposited substances are usually atoms, molecules, or a combination of both. It can be understood that the CVD coating or the PVD coating can be uniformly deposited on the surface of the electrode substrate without affecting the roughness of the electrode substrate and the conductivity of the electrode substrate.

[0076] In some specific embodiments, the color - developing coating includes at least one of a TiN gold coating, a Cr - N - Si blue coating, a Cr - N - Si green coating, and a TiO purple coating.

[0077] The second aspect of the present application provides a method for preparing the above - mentioned electrosurgical electrode, including:

[0078] Preparing an electrode substrate using a tungsten - based high - specific - gravity alloy;

[0079] Preparing an anti - tissue - adhesion nano - coating on at least a partial area of the surface of the electrode substrate.

[0080] Specifically, the processing technology of the electrode substrate includes two types: machining and MIM (Metal Injection Molding). Machining is to process and clean the electrode substrate using a WNiCu rod to obtain an electrode with an original surface. MIM processing is to prepare the electrode substrate using W, Ni, and Cu metal powders with a particle size of 2 - 10 μm, and then through surface deburring and cleaning and drying treatments to obtain an electrode with an original surface.

[0081] In some embodiments, an anti - tissue - adhesion nano - coating can be prepared on the surface of the electrode substrate by supersonic cold spraying, electroless plating, or chemical vapor deposition.

[0082] In some specific embodiments, using nickel - iron - teflon as a raw material, a chemical vapor deposition coating or an electroless plating coating can be prepared on the surface of the electrode substrate by chemical vapor deposition or electroless plating, and thus a coating with an anti - tissue - adhesion effect can be obtained.

[0083] In some specific embodiments, using PTFE as a raw material, an anti - tissue - adhesion nano - coating can be prepared on the surface of the electrode substrate by supersonic cold spraying.

[0084] In some embodiments, before preparing the anti - tissue - adhesion nano - coating on at least a partial area of the surface of the electrode substrate, it further includes:

[0085] A color-developing coating is deposited on at least a portion of the surface of the electrode substrate, so that the anti-tissue adhesion nano coating covers the color-developing coating.

[0086] It should be noted that the surface state of the electrode processed by machining or MIM is still relatively rough. Due to the precise size and structure of the electrode, it is difficult to obtain a good surface state whether by mechanical polishing or electrolytic polishing. The color coating with high density and high bonding strength is conducive to improving the surface activity, wear resistance and arc ablation resistance of the electrode substrate; further, the color coating with different colors can improve the recognizability of the electrode, making it easier for the operator to observe the location of the electrode under endoscopy.

[0087] In some specific embodiments, a color-developing coating can be deposited on the surface of the electrode substrate by PVD.

[0088] Furthermore, a third aspect of the present application provides the use of the above-mentioned electrosurgical electrode in the preparation of an electrosurgical energy instrument.

[0089] A fourth aspect of the present application provides an electrosurgical energy device, comprising the above-mentioned electrosurgical electrode, thereby improving the ablation resistance of the electrosurgical energy device and reducing adhesion to tissues.

[0090] In some specific implementation schemes, the electrosurgical energy device is a high-frequency electric knife, which can be used for cutting body tissues, injecting fluids, etc. in surgical operations. According to the functions and uses of high-frequency surgical instruments, high-frequency electric knives can be divided into the following types: multifunctional high-frequency electric knives: with pure cutting, mixed cutting, monopolar coagulation, electrocautery, bipolar coagulation and other functions; monopolar high-frequency electric knives: with pure cutting, mixed cutting, monopolar coagulation, electrocautery and other functions; bipolar coagulators: with bipolar coagulation and other functions; electrocautery devices: with monopolar electrocautery and other functions; endoscope-specific high-frequency generators: with pure cutting, mixed cutting, and monopolar coagulation functions; high-frequency argon gas knives: with argon gas protection cutting and argon arc jet coagulation functions; multifunctional high-frequency beauty devices: with spot coagulation, spot cautery, and ultra-high frequency electrocautery and other functions.

[0091] The excellent effects of the high-frequency electrosurgical unit of this application include:

[0092] Adopt WNiCu alloy with W content of more than 80% to solve the problem of poor arc erosion resistance of high-frequency electric knife electrodes;

[0093] The Ni-P-PTFE coating is prepared on the surface of the WNiCu alloy electrode by chemical plating or chemical vapor deposition to solve the problem of poor arc ablation resistance and poor tissue adhesion resistance of high-frequency electrosurgical knife electrodes;

[0094] The nano-PTFE coating is prepared on the surface of the WNiCu alloy electrode by using the supersonic cold spraying technology. The coating has high bonding strength and thin thickness. The nanoparticles are filled in the concave parts of the substrate surface, but the wave crests are not filled. The conductivity is conducted through the convex surface of the electrode substrate itself, which retains the conductivity of the substrate itself and solves the problems of poor arc ablation resistance and poor tissue adhesion resistance of high-frequency electrosurgical electrode.

[0095] The nanocomposite structure coating was prepared on the surface of WNiCu alloy electrode by PVD and supersonic spraying method to solve the problems of poor arc erosion resistance and poor tissue adhesion resistance of high-frequency electrosurgical knife electrodes. The electrodes were given different colors to improve their recognizability, making it easier for operators to observe the location of the electrodes under endoscopy.

[0096] The following are specific embodiments.

[0097] The preparation process of the electrosurgical electrode provided in this embodiment includes an electrode processing process and a coating preparation process. The electrode structure prepared by the electrode processing process can be T-shaped or I-shaped. Specifically, the T-shaped electrosurgical electrode structure is as follows: Figure 1 As shown in (A) and (B), the structure of type I electrosurgical electrode is as follows Figure 2 As shown in (A) and (B), a stepped micropore is designed in the middle of the electrode, integrating the functions of electrocuting and liquid injection.

[0098] 1. Electrode processing technology

[0099] The electrode processing technology provided in this embodiment includes two types: machining and MIM processing.

[0100] (1) Machining: The raw material is WNiCu rod with a diameter of Φ4 mm, which is prepared by Xiamen Chinatungsten Online Technology Co., Ltd. Its chemical composition (mass fraction) is: 1% to 7% Ni, 0.5% to 3% Cu, 90% to 95% W, and the ratio of Ni:Cu is 3:2 to 4:1. The WNiCu rod is used for electrode processing and cleaning. The specific process flow is as follows: Figure 3 shown.

[0101] (2) MIM processing: The raw materials are W, Ni, and Cu powders with a particle size of 2 to 10 μm, and their composition (mass fraction) is: 1% to 7% Ni, 0.5% to 3% Cu, 90% to 95% W, and the ratio of Ni:Cu is 3:2 to 4:1. The electrode prepared by MIM is then subjected to surface deburring, cleaning and drying to obtain the original surface electrode, such as Figure 4 As shown in A.

[0102] 2. Coating preparation process

[0103] There are two coating preparation processes provided in this embodiment:

[0104] (1) Anti-adhesion nano-coating, prepared by coating supplier: Billanda (Anhui) Nano Coating Technology Co., Ltd., and the preparation method is as Figure 5 shown. The adhesion of the coating was tested according to ASTM D3359-17 (Method B), and the test result was that there was no peeling off within the scratch tape grid, indicating that the adhesion of the anti-adhesion nano-coating meets the usage requirements.

[0105] (2) Color-developing coating, prepared by coating supplier Arison Surface Technology (Suzhou) Co., Ltd., and the preparation method is as follows Figure 6 shown.

[0106] 3. Coating electrode process

[0107] There are three coating electrode process schemes provided in this embodiment:

[0108] (1) Grey-black coating electrode

[0109] The process scheme is as follows:

[0110] a. Use WNiCu alloy to prepare the high-frequency electrotome electrode, and the preparation process includes machining and MIM technology;

[0111] b. Prepare Ni-P-PTFE coating on the electrode surface by electroless plating or chemical vapor deposition. The thickness of the electroless plating coating is about 3-5μm, and the thickness of the chemical vapor deposition coating is about 1-3μm; the color of the coating is grey-black and is easily recognizable under the endoscope.

[0112] (2) Transparent coating electrode

[0113] Keep the matrix in silver-white state, which is easily recognizable under the endoscope, as shown in B in Figure 4 The process scheme is as follows:

[0114] a. Use WNiCu alloy to prepare the high-frequency electrotome electrode, and the preparation process includes machining and MIM technology;

[0115] b. Use supersonic spraying technology to prepare an anti-adhesion coating with a thickness of 3-5μm on the electrode surface.

[0116] (3) Color coating electrode

[0117] The process scheme is as follows:

[0118] a. Use WNiCu alloy to prepare the high-frequency electrotome electrode, and the preparation process includes machining and MIM technology;

[0119] b. Use PVD technology to deposit TiN (gold) or Cr-N-Si (blue) or Cr-N-Si (green) or TiO (purple) coating on the electrode surface, and the coating thickness is 0.5-2.5μm. The TiN (gold) coating is asFigure 7 As shown in A, the Cr-N-Si (blue) coating is as Figure 7 As shown in B, the Cr-N-Si (green) coating is as Figure 7 shown in C;

[0120] c. A tissue adhesion prevention transparent coating is prepared on the color display coating by supersonic cold spraying technology, and the coating thickness is 3 - 5 μm.

[0121] The above coating electrode process scheme is used to improve the problems of tissue adhesion to the tool tip and arc ablation resistance during high-frequency electrotome cutting on the premise of ensuring the conductivity of the high-frequency electrotome. The color coating electrode is used to introduce different colors to the electrode. Electrodes with different color coatings are beneficial for classification according to the use characteristics of the electrode or the operating habits of the operator, and customized services can be provided.

[0122] 4. Electrode resistance before and after coating

[0123] In this embodiment, a T-shaped electrode is selected. After applying a tissue adhesion prevention coating or a color display coating on the electrode surface through the above coating electrode process scheme, resistance testing is carried out, and at the same time, the coating is prepared by dip coating or spraying for comparative testing. Specifically, the resistance test data of the original surface electrode and the coating electrode prepared in this embodiment are shown in Table 1 below.

[0124] Table 1

[0125]

[0126] The test results show that the resistance of the coating electrode prepared by the coating electrode process scheme of this embodiment has no obvious change, about 0.10 Ω - 0.20 Ω, while the resistance of the PTFE coating electrode prepared by the conventional dip coating or spraying method exceeds the range; it can be seen that both the electrode substrate and the coating prepared by the coating electrode process scheme of this embodiment have good conductivity.

[0127] Furthermore, in this embodiment, a T-shaped electrode is selected. After applying a tissue adhesion prevention coating on the electrode surface, it is used to replace the electrode used in the high-frequency electrotome control product to prepare a new type of high-frequency electrotome, and resistance testing is carried out.

[0128] The resistance test results of the new type of high-frequency electrotome and the high-frequency electrotome control product (Nanwei Medical Technology Co., Ltd., National Medical Device Approval No. 20223010934) in this embodiment are shown in Table 2.

[0129] Table 2

[0130]

[0131] 5. Anti-tissue adhesion performance test

[0132] In this embodiment, the anti-tissue adhesion performance of the anti-tissue adhesion coating of the above-mentioned new high-frequency electrosurgical knife was tested. The test scheme is shown in Table 3 below. The tissue adhesion situation and tissue morphology of the electrode during the test are as Figure 8 shown, and the specific comparison results of the test results are shown in Table 4 below.

[0133] Table 3

[0134]

[0135] Table 4

[0136]

[0137]

[0138] According to the test results in Table 4, it can be seen that when the new high-frequency electrosurgical knife provided in this embodiment performs electrocision, the adhesion of the electrode to the tissue is reduced, the phenomenon of becoming "blunt" is alleviated, the tissue damage is smaller, and the tissue adhered to the electrode is easy to remove, making the cutting continuity of the high-frequency electrosurgical knife better. Under the condition of longer use time, the tissue adhered to the electrode is still significantly less than that of the control product.

[0139] In summary, for the electrosurgical electrode provided in this embodiment, after the electrode substrate and the anti-tissue adhesion nano-coating are combined, it still has excellent electrical conductivity, can improve the anti-tissue adhesion performance of the electrode, can improve the recognizability of the electrode, facilitate the operator to observe the position of the electrode under the endoscope, and at the same time can improve the arc ablation resistance performance of the electrode, solve the problem that the stainless steel electrode of the traditional high-frequency electrosurgical knife is easy to ablate during long-term use, and improve the use performance of the high-frequency electrosurgical knife.

[0140] The technical features of the above embodiments can be combined arbitrarily. For the sake of concise description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope recorded in this specification.

[0141] The above embodiments only represent several implementation manners of the present invention. The description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several deformations and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the invention patent should be subject to the appended claims.

Claims

1. An electrosurgical electrode, characterized in that, It includes an electrode substrate and an anti-tissue adhesion nano-coating, and the anti-tissue adhesion nano-coating covers at least a partial area of the surface of the electrode substrate. Among them, the electrode substrate contains a tungsten-based high-density alloy, the anti-tissue adhesion nano-coating is a polymer nano-coating, and the thickness of the anti-tissue adhesion nano-coating is 1 to 5 μm.

2. The electrosurgical electrode according to claim 1, characterized in that, The electrosurgical electrode satisfies at least one of the following characteristics (1) to (4): (1) The resistance of the electrosurgical electrode is 0.10 Ω to 0.20 Ω; (2) The electrosurgical electrode is a T-shaped electrode or an I-shaped electrode; (3) The electrosurgical electrode has a through hole with a diameter of 0.12 to 0.35 mm; optionally, the through hole is a stepped hole; (4) The electrosurgical electrode further includes a color-developing coating, the color-developing coating covers at least a partial area of the surface of the electrode substrate, and the anti-tissue adhesion nano-coating covers the color-developing coating.

3. The electrosurgical electrode according to claim 2, characterized in that, The tungsten-based high-density alloy is a WNiCu or WNiFe alloy or a tungsten-based high-density alloy with a density greater than 17.0 kg / m 3 ³.

4. The electrosurgical electrode according to claim 3, characterized in that, Calculated according to the total mass of the electrode substrate, the content of Ni in the electrode substrate is 1% to 7%, the content of Cu is 0.5% to 3%, and the content of W is the balance. Among them, the mass ratio of Ni and Cu is 3:2 to 4:1; or, The content of Ni in the electrode substrate is 1% to 7%, the content of Fe is 1% to 3%, and the content of W is the balance. Among them, the mass ratio of Ni and Fe is 1:1 to 4:1; or, The content of W in the electrode substrate is 80% to 99%, and among them, the balance is the content of rare earth element RE or one or more metal elements of Co, Mo, and Cr.

5. The electrosurgical electrode according to claim 2, characterized in that, The coating covering the surface of the electrosurgical electrode satisfies at least one of the following characteristics (1) to (5): (1) The anti-tissue adhesion nano-coating is a thermal spray coating, a cold spray coating, a supersonic cold spray coating, an electroless plating coating, or a chemical vapor deposition coating; (2) The color-developing coating includes a CVD or PVD coating; (3) The anti-tissue adhesion nano-coating is selected from a PTFE coating or a nickel teflon coating; (4) The color-developing coating includes at least one of a TiN coating, a Cr-N-Si coating, and a TiO coating; (5) The thickness of the color-developing coating is 0.5 to 2.5 μm.

6. Use of the electrosurgical electrode according to any one of claims 1 to 5 in the preparation of an electrosurgical energy instrument.

7. An electrosurgical energy instrument, characterized in that, It includes the electrosurgical electrode according to any one of claims 1 to 5.

8. The electrosurgical energy instrument according to claim 7, characterized in that, The electrosurgical energy device is a high-frequency electrotome.

9. A method for preparing the electrosurgical electrode according to any one of claims 1 to 5, characterized in that, It includes: Preparing an electrode substrate using a tungsten-based high-density alloy; Preparing an anti-tissue adhesion nano-coating on at least a partial area of the surface of the electrode substrate.

10. The preparation method according to claim 9, characterized in that, Before preparing the anti-tissue adhesion nano-coating on at least a partial area of the surface of the electrode substrate, it further includes: Preparing a color-developing coating on the surface of the area of the electrode substrate corresponding to the anti-tissue adhesion nano-coating, so that the anti-tissue adhesion nano-coating covers the color-developing coating.

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