Electrosurgical electrode

Abstract

An object of the present invention is to provide an electrosurgical electrode capable of suppressing excessive temperature rise in a portion that can be an operation part. The electrosurgical electrode is used for surgery on biological tissue and has a main body portion capable of releasing high-frequency energy. The surface of the main body portion has a coated portion (A) covered with a resin coating having a thickness of 10 μm or more, and a region (B) covered with an oxide film and / or a resin coating having a thickness of 1.0 μm or less or not coated. The region (B) is an effective surface capable of emitting high-frequency energy from the main body portion to biological tissue, and the ratio (β1 / α1) of the area (β1) of the region (B) to the area (α1) of the coated portion (A) is in the range of 0.01 or more and 0.5 or less.

Description

Technical Field

[0001] The present invention relates to an electrosurgical electrode for an electrosurgical instrument used for surgery on biological tissue as a medical device. Background Art

[0002] In surgical operations, an electrosurgical instrument (so-called surgical electrotome) is essential, which can perform hemostasis (coagulation) or incision by emitting high-frequency current generated by a main body from the electrosurgical electrode to biological tissue. As a problem caused by using a surgical electrotome, there is a problem of "scab" in which carbides such as biological tissue adhere to the tip of the surgical electrotome. In response to this problem, a method has been proposed, which is characterized in that a large number of electrodes capable of connecting each electrode to an appropriate power source for surgical operations are mass-produced, and the method includes a step of preparing a conductive stock material having a shape and size capable of forming a plurality of electrode blanks, and the method further includes: a step of coating a non-adhesive layer on at least a part of the stock material; and a step of forming the plurality of coated electrode blanks (see Patent Document 1).

[0003] Prior Art Documents

[0004] Patent Documents

[0005] Patent Document 1: Japanese Patent Application Laid-Open No. 2000-333968. Summary of the Invention

[0006] Problems to be Solved by the Invention

[0007] However, since the electrosurgical electrode described in Patent Document 1 has a non-adhesive layer, it is difficult for heat to be released from the surface of the electrosurgical electrode, and sometimes the temperature of the front end portion of the electrosurgical electrode, that is, the working area closest to the biological tissue and cutting the biological tissue and / or performing hemostasis, rises excessively. If the temperature of the front end portion of the electrosurgical electrode rises excessively, there is a problem that excessive heat invasion occurs by transferring more heat than necessary from the working area to the affected area, thereby damaging healthy tissue.

[0008] The present invention has been completed to solve such problems, and an object thereof is to provide an electrosurgical electrode capable of suppressing excessive temperature rise in the working area.

[0009] Means for Solving the Problems

[0010] The inventor of the present invention has conducted repeated research to solve the above problems and found that the problems can be solved by an electrosurgical electrode for use in surgery on biological tissue. The electrosurgical electrode has a main body portion capable of releasing high-frequency energy. The surface of the main body portion has a coated portion (A) covered with a resin coating having a thickness of 10 μm or more, and a region (B) covered with an oxide film and / or a resin coating having a thickness of 1.0 μm or less or not coated. The region (B) is an effective surface capable of emitting high-frequency energy from the main body portion to the biological tissue, and the ratio (β1 / α1) of the area (β1) of the region (B) to the area (α1) of the coated portion (A) is in the range of 0.01 or more and 0.5 or less.

[0011] Further, as another method, it has been found that the problems can be solved by an electrosurgical electrode for use in surgery on biological tissue. The electrosurgical electrode has a main body portion capable of releasing high-frequency energy. The surface of the main body portion has a coated portion (A) covered with a resin coating having a thickness of 10 μm or more, and a region (B) covered with an oxide film and / or a resin coating having a thickness of 1.0 μm or less or not coated. The region (B) includes the working region of the main body portion closest to the biological tissue for cutting the biological tissue and / or performing hemostasis. The region (B) includes a surface that is in contact with all or a part of the working region, and the surface includes a region surrounded by a line in contact with the working region and a line translated perpendicularly from the line by at least 2.0 mm along the surface.

[0012] That is, the present invention may include the following technical solutions.

[0013] (1) An electrosurgical electrode for use in surgery on biological tissue, which has a main body portion capable of releasing high-frequency energy,

[0014] The surface of the main body portion has a coated portion (A) covered with a resin coating having a thickness of 10 μm or more, and a region (B) covered with an oxide film and / or a resin coating having a thickness of 1.0 μm or less or not coated.

[0015] The region (B) is an effective surface capable of emitting high-frequency energy from the main body portion to the biological tissue,

[0016] The ratio (β1 / α1) of the area (β1) of the region (B) to the area (α1) of the coated portion (A) is in the range of 0.01 or more and 0.5 or less.

[0017] (2) An electrosurgical electrode for use in surgery on biological tissue, which has a main body portion capable of releasing high-frequency energy,

[0018] The surface of the main body has a coated portion (A) covered with a resin coating having a thickness of 10 μm or more, and an area (B) covered with an oxide film and / or a resin coating having a thickness of 1.0 μm or less or not coated.

[0019] The area (B) includes a working area in the main body closest to the biological tissue for incising the biological tissue and / or performing hemostasis.

[0020] The area (B) includes a surface in contact with all or a part of the working area, and the surface includes an area surrounded by a line in contact with the working area and a line translated perpendicularly from the line along the surface by at least 2.0 mm.

[0021] (3) The electrosurgical electrode according to (1) above, wherein

[0022] The area (B) includes a working area in the main body closest to the biological tissue for incising the biological tissue and / or performing hemostasis.

[0023] The area (B) includes a surface in contact with all or a part of the working area, and the surface includes an area surrounded by a line in contact with the working area and a line translated perpendicularly from the line along the surface by at least 2.0 mm.

[0024] (4) The electrosurgical electrode according to any one of (1) to (3) above, wherein

[0025] The main body includes a front surface as a main surface, a back surface opposite to the front surface, and side surfaces sandwiched between the front surface and the back surface, and the side surfaces include the area (B).

[0026] (5) The electrosurgical electrode according to any one of (1) to (3) above, wherein

[0027] The main body has an annular structure.

[0028] (6) The electrosurgical electrode according to any one of (1) to (3) above, wherein

[0029] The main body has a rod-like structure, and the extended front end of the rod-like structure includes a needle structure.

[0030] (7) The electrosurgical electrode according to any one of (1) to (3) above, wherein

[0031] The main body has a spherical structure.

[0032] Advantages of the Invention

[0033] According to the present invention, an electrosurgical electrode capable of suppressing excessive temperature rise in a portion that can be a working area can be provided. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 FIG. is a schematic view showing an example (blade electrode) of an electrosurgical electrode (operating electrosurgical knife).

[0035] Figure 2 FIG. is a schematic view showing an example of a coating portion (A) and a region (B) of the electrosurgical electrode. DETAILED DESCRIPTION OF THE INVENTION

[0036] An embodiment of the present invention is an electrosurgical electrode for surgery on biological tissue, having a main body portion capable of releasing high-frequency energy. Further, a coating portion (A) covered with a resin coating having a thickness of 10 μm or more and a region (B) covered with an oxide film and / or a resin coating having a thickness of 1.0 μm or less or not coated are provided on the surface of the main body portion, and the region (B) is an effective surface capable of emitting high-frequency energy from the main body portion to biological tissue.

[0037] <Electrosurgical Electrode>

[0038] An electrosurgical electrode is an electrode detachably attached to the front end of an electrosurgical instrument such as a so-called operating electrosurgical knife, and can perform hemostasis (coagulation) or incision of biological tissue by emitting high-frequency from the main body portion of the electrode to biological tissue. The electrosurgical electrode is made of a conductive material. More specifically, examples include iron-based metal materials, galvanized metal materials, aluminum-based metal materials, magnesium-based metal materials, nickel-based metal materials, titanium-based metal materials, zirconium-based metal materials, copper-based metal materials, tin-based metal materials, tungsten-based metal materials, chromium-based metal materials, manganese-based metal materials, molybdenum-based metal materials, cobalt-based metal materials, etc., but stainless steel is more preferred. Examples of electrosurgical instruments equipped with electrosurgical electrodes typically include operating electrosurgical knives such as monopolar scalpels or bipolar scalpels, laparoscopes, etc. Examples of monopolar scalpels include scalpels having shapes such as blade type, ring structure type, rod structure type having a needle structure at the front end, spherical structure type, etc. In Figure 1 FIG. shows a schematic view of an example of an electrosurgical electrode.

[0039] Figure 1 FIG. is a schematic view showing an example of a blade-type electrosurgical electrode with a plate-shaped front end portion.

[0040] The electrosurgical electrode 10 is a member detachably attachable to an electrosurgical instrument main body (not shown). The electrosurgical electrode 10 includes an electrical connection portion 13 electrically connected to the electrosurgical instrument main body, a main body portion 11 that emits high-frequency close to biological tissue, and an intermediate portion 12 that connects the electrical connection portion 13 and the main body portion 11.

[0041] Figure 2 is an enlarged view of the main body portion 11 Figure 1 after magnification. In the present embodiment, the surface of the main body portion 11 includes: a coated portion (A) 111 (the hatched area in the figure) covered with a resin coating having a thickness of 10 μm or more; and an area (B) 112 (the dotted area in the figure) covered with an oxide film and / or a resin coating having a thickness of 1.0 μm or less or not coated.

[0042] The main body portion 11 is generally rectangular in shape, having a front surface as a main surface, a back surface opposite to the front surface, and a front end portion (front end surface) and side surface portions (both side surfaces) sandwiched between the front surface and the back surface. Moreover, a part of the front end portion and the side surface portions includes an area (B) covered with an oxide film and / or a resin coating having a thickness of 1.0 μm or less or not coated. In addition, although the area (B) preferably exists in the front end portion and the side surface portions, it is not limited to the front end portion and the side surface portions, and may also exist in a part of the front surface and / or the back surface. Specifically, the front end portion 112a and a part 112b of the side surface connected to the front end portion can be the area (B). In addition, although in the present embodiment, the area (B) is a part of the side surface portion, it may also be the entire side surface portion.

[0043] In addition, the front end portion 112a can be a working area closest to the biological tissue for cutting the biological tissue and performing hemostasis. In addition, although in Figure 2 the shown blade-type electrosurgical electrode, the main body portion is rectangular, but it is not limited thereto, as long as it has a shape having a front surface, a back surface, a front end portion, and side surface portions. In addition, the sizes (areas) of the front surface and the back surface may be the same or different. In the present specification, the main surface refers to the plane having the largest area.

[0044] In the present embodiment, the ratio (β1 / α1) of the area (β1) of the area (B) 112 to the area (α1) of the coated portion (A) 111 is in the range of 0.01 or more and 0.5 or less.

[0045] On the surface of the main body portion 11, by setting the value of (β1 / α1) within the above range, an electrosurgical electrode capable of suppressing an excessive rise in the temperature of a portion that can be a working area is formed. The range of (β1 / α1) is preferably 0.027 or more, and preferably 0.476 or less.

[0046] The coating part (A) 111 may also be covered with a resin coating having a thickness of 10 μm or more. Examples of the resin coating include fluororesins such as Teflon (registered trademark) and PTFE, or silicone resins, etc., and preferably has an anti-adhesion function (anti-fouling function). The resin coating may be a single layer or a multi-layer laminate. In the case of a multi-layer laminate, the multi-layers may be the same resin or different resins. In addition, an oxide film may also be provided between the resin coating and the main body part.

[0047] The resin coating can be formed by bringing a resin composition containing a fluororesin and a silicone resin into contact with the main body part 11. The resin composition may include additives such as fillers, plasticizers, mold release agents, and cross-linking agents. The thickness of the resin coating may be 20 μm or more, or may be 30 μm or more. In addition, there is no particular limitation on the upper limit, and it may also be 1 mm or less.

[0048] The region (B) is a region covered with an oxide film and / or a resin coating having a thickness of 1.0 μm or less or an uncoated region, and the region (B) is an effective surface capable of emitting high-frequency energy from the main body part to the biological tissue. Therefore, when using an electrosurgical instrument equipped with an electrosurgical electrode, it includes the working area closest to the biological tissue for incising the biological tissue and / or performing hemostasis.

[0049] The oxide film and / or resin coating that the region (B) may have is extremely thin compared to the resin coating (A), and its thickness is 1.0 μm or less, but may also be 0.9 μm or less, may also be 0.8 μm or less, may also be 0.7 μm or less, may also be 0.6 μm or less, may also be 0.5 μm or less, may also be 0.4 μm or less, may also be 0.3 μm or less, may also be 0.2 μm or less, may also be 0.1 μm or less, may also be 0.05 μm or less.

[0050] In another embodiment, the region (B) includes a surface that is in contact with all or a part of the working area closest to the biological tissue in the main body part for incising the biological tissue and / or performing hemostasis, and the surface may include a region surrounded by a line in contact with the working area and a line translated perpendicularly from this line along this surface by at least 2.0 mm. Since the region (B) exists within such a range, it is possible to prevent the temperature of the working area from rising excessively due to heat accumulation around the working area for incising the biological tissue and / or performing hemostasis. Preferably, the region (B) may include a region surrounded by this line and a line translated perpendicularly from this line along this surface by at least 3.0 mm.

[0051] As described above, the region (B) may include the front end portion 112a, may also include a part 112b of the side face portion, and may also include a part of the front and / or back faces. However, preferably, the region (B) includes the front end portion 112a, more preferably includes a part 112b of the side face portion, and still more preferably includes a part of the front and / or back faces. That is, the order of priority of the parts that can be part of the region (B) is the front end portion 112a, a part 112b of the side face portion, and the front and back faces. In addition, preferably, a part of the region (B) from the front end side exists on the side face, the front face, and the back face.

[0052] In addition, the region surrounded by a line in contact with the working region and a line translated perpendicularly from this line by at least 2.0 mm along the plane including the working region may or may not be covered with an oxide film and / or a resin coating having a thickness of 1.0 μm or less.

[0053] The main body portion of the electrosurgical electrode according to an embodiment of the present invention can be manufactured, for example, by the following method. In one example, after subjecting the main body portion to degreasing treatment, substrate treatment, etc. as needed, the main body portion is immersed in a resin coating composition, and resin coating is performed on the entire surface of the main body portion. Thereafter, it can be manufactured by scraping the front end portion and the side face portion in the main body portion and scraping the desired portions of the front face and the back face as needed. For degreasing treatment, substrate treatment, etc., there is no particular limitation as long as an oxide film and / or a resin coating can be formed, and known methods can be used. In addition, for the resin coating composition, there is no particular limitation as long as it is a resin composition containing a fluorine-based resin or a silicone-based resin.

[0054] <Shape of the main body portion>

[0055] The shape of the main body portion 11 is not particularly limited. In addition to Figure 2 the blade shape of the main body portion 11 shown, it may also be an annular shape (ring shape), a spherical shape, or a needle shape. These are electrosurgical electrodes used as the tip electrode of a surgical electrotome. In addition to these, it may also be an electrosurgical electrode installed in a laparoscope, such as a wire L-hook type, a straight scraper type, a wire J-hook type, a syringe type, etc. Although the main body portions exemplified so far are all monopolar electrosurgical electrodes, they may also be bipolar electrosurgical electrodes.

[0056] <Electrical connection portion>

[0057] The electrical connection part 13 is the part in the electrosurgical electrode 10 that is electrically connected to the electrosurgical instrument main body. The electrical connection part 13 can be attached to and detached from the electrosurgical instrument main body. Generally, the electrical connection part 13 and the electrosurgical instrument main body are configured to be able to be engaged through a fitting structure or the like. In addition, the electrical connection part is also made of a conductive material. The constituent material can be the same as or different from that of the main body part 11.

[0058] <Intermediate part>

[0059] The intermediate part 12 is a member that connects the main body part 11 and the electrical connection part 13. In order to energize the main body part 11, it needs to be made of a conductive material, but its shape, length, etc. are not particularly limited.

[0060] The intermediate part 12 may have a covering 14. The covering 14 is a cured product of a composition containing a resin having insulating properties. In addition, as long as the intermediate part 12 is in contact with the covering 14, the size, thickness, shape, etc. of the covering 14 are not particularly limited.

[0061] Examples

[0062] Hereinafter, the effects of the present invention will be specifically shown by examples. However, the descriptions related to the following examples do not limit the scope of the present invention in any way.

[0063] <Manufacture of the main body part>

[0064] Prepared Figure 1 The main body part 11 shown is a blade-type electrosurgical electrode in the shape of a plate. The material of the prepared electrosurgical electrode and the dimensions of the blade part are as follows.

[0065] Material of the electrosurgical electrode: Stainless steel SUS304;

[0066] Dimensions of the blade part: Plate 0.3 mm; Length 17.0 mm; Width 2.5 mm; Area 0.00009595 m 2 .

[0067] The blade part of the electrosurgical electrode was immersed in ethanol (manufactured by Junsei Chemical Co., Ltd., first grade), and ultrasonic waves were applied for 10 minutes to remove oil and dirt on the surface. Thereafter, the blade part was dried at 100 °C for 10 minutes to remove the attached ethanol.

[0068] On the blade part after removing oil and dirt, a silicone composition (manufactured by Shin-Etsu Chemical Co., Ltd., product name ES-1002T) was applied using the following dispensing machine, and thereafter, it was dried at a drying temperature of 150 °C for 30 minutes to obtain an electrosurgical electrode having a silicone coating with a film thickness of 70 μm.

[0069] Dispensing Machine (Desktop Robot): Manufactured by Musashi High-Tech, Product Name: ML-808GX, SM4000MEGAX-3A-SS.

[0070] <Evaluation Test>

[0071] Use a cutting knife to scrape off the coating at the front end part ( Figure 2 112a in) of the silicon coating covering the main body part 11. Take the main body part 11 in this state as Comparative Example 1. Next, use a cutting knife to scrape off the coating on a part of the side face ( Figure 2 112b in) so that the distance from the front end part 112a is the distance shown in Table 1, as Examples 1 to 6. In addition, when scraping off the coating on the side face, do it on the opposite two sides.

[0072] Next, use a cutting knife to scrape off the coating on the front and back of the main body part 11 made in Example 6 so that the distance from the front end part is the distance shown in Table 1, as Examples 7 to 10 and Comparative Examples 2 to 3. Furthermore, take the electrosurgical electrode with the coating of the main body part 11 not scraped off at all as Comparative Example 4.

[0073] Measure the maximum temperature and temperature rise of the electrosurgical electrodes of Examples 1 to 10 and Comparative Examples 1 to 4. Specifically, insert the main body part 11 (17 mm from the front end part) into a container filled with pig blood, and use an infrared camera to measure the temperature of the front end part of the main body part when discharging at an output power of 75 W for 5 seconds. The maximum temperature of the main body part is the maximum temperature of the main body part 11 measured within 5 seconds. In addition, calculate the temperature rise rate per unit time based on the measured temperature change, as the temperature rise per 1 second.

[0074] The evaluation criteria are as follows. The results are shown in Table 1.

[0075] <Maximum Temperature of the Main Body Part at 5 Seconds of Discharge>

[0076] ◎: 270 °C or below

[0077] 〇: Greater than 270 °C and 320 °C or below

[0078] △: Greater than 320 °C and 350 °C or below

[0079] ×: Greater than 350 °C

[0080] <Temperature Rise per 1 Second>

[0081] ◎: 90 °C / s or below

[0082] 〇: Greater than 90 °C / s and 100 °C / s or below

[0083] △: Greater than 100 °C / s and 120 °C / s or below

[0084] ×: Greater than 120 °C / s

[0085] [Table 1]

[0086] Table 1

[0087]

[0088] In addition, regarding the present invention, although it has been described in detail with reference to specific embodiments, it is obvious to those skilled in the art that various changes and modifications can be made without departing from the gist and scope of the present invention.

[0089] Explanation of reference numerals

[0090] 10: Electrosurgical electrode

[0091] 11: Main body part

[0092] 111: Coating part

[0093] 112: Area

[0094] 112a: Front end part

[0095] 112b: Part of the side face

[0096] 12: Intermediate part

[0097] 13: Electrical connection part

[0098] 14: Cover

Claims

1. An electrode for electro-surgery, which is used for the surgery of biological tissues, and has a main body portion capable of releasing high-frequency energy and an electrical connection portion. The surface of the main body portion has a coated portion A covered with a resin coating having a thickness of 10 μm or more; and a region B. The region B is an uncoated region, or the region B is a region covered with an oxide film or a resin coating having a thickness of 1.0 μm or less, or the region B is a region covered with an oxide film and a resin coating having a total thickness of 1.0 μm or less. The region B is an effective surface capable of emitting high-frequency energy from the main body portion to biological tissues. The main body portion is made of stainless steel. The main body portion is generally rectangular and plate-shaped, and has a main surface, a back surface opposite to the main surface, a front end surface and two side surfaces sandwiched between the main surface and the back surface. One end of the main body portion is a connection end portion connected to the electrical connection portion, and the front end surface is located at the other end opposite to the connection end portion. The front end surface is the region B. In the two side surfaces, the region B exists in a region having a length of 2 mm to 10 mm from the front end surface toward the connection end portion. The ratio β1 / α1 of the area β1 of the region B to the area α1 of the coated portion A is 0.0207447 or more and 0.0756726 or less.

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