Treatment portion of energy device for medical use, method for manufacturing the same, and energy device for medical use

Abstract

A treatment unit of a medical energy device treats biological tissue by transferring energy to the tissue in contact with it. The treatment unit comprises a main body and a covering membrane. The main body transfers energy to the biological tissue. The covering membrane, primarily composed of organosilicon, covers the surface of the main body. In the organosilicon, the molar ratio of silicon atoms forming D-units to all silicon atoms is 40% or more and 99% or less. In the organosilicon, the molar ratio of methyl groups bonded to silicon atoms to all functional groups bonded to silicon atoms is 60% or more.

Description

Technical Field

[0001] This invention relates to the treatment section of a medical energy device, its manufacturing method, and the medical energy device itself. Background Technology

[0002] In the processing section of medical energy devices, it is known to have a structure in which an organosilicon film is formed on the surface of a metal substrate. For example, in Patent Document 1, as an example of a medical energy device, a high-frequency knife is described in which an organosilicon resin film containing a conductive material is formed on the surface of a metal electrode portion.

[0003] Existing technical documents

[0004] Patent documents

[0005] Patent Document 1: Japanese Patent Application Publication No. 2018-75303 Summary of the Invention

[0006] The problem that the invention aims to solve

[0007] However, the following problems exist in the aforementioned background technology.

[0008] In medical energy devices, the treatment unit heats biological tissue in contact with it, thereby performing treatments such as cutting, cauterizing, and coagulating the tissue. Through repeated treatments, repeated temperature loads are generated in the treatment unit.

[0009] For example, in the medical energy device illustrated in Patent Document 1, a silicone resin film is formed on the surface of a metal electrode portion in the treatment section. In this case, due to the difference in the coefficients of thermal expansion between the electrode portion and the silicone resin film, repeated thermal stress is generated in the silicone resin film. As a result, cracks occur in the silicone resin film, or the silicone resin film peels off from the electrode portion. If such cracks or peeling occur, biological tissue can easily adhere to the treatment section, thus reducing treatment performance or making treatment difficult.

[0010] In recent years, in order to improve processing performance, there has been a strong demand for processing at higher temperatures in the processing unit. For example, in the case of silicone resin films, repeated processing at temperatures above 300°C can easily lead to cracking, peeling, and other defects, potentially reducing the lifespan of the processing unit.

[0011] The present invention was made in view of the above-mentioned problems, and its object is to provide a treatment part of a medical energy device that can improve the durability of repeated treatments, a method for manufacturing the same, and the medical energy device.

[0012] means for solving problems

[0013] To address the aforementioned problems, the treatment unit of a medical energy device according to a first aspect of the present invention treats biological tissue by transferring energy to the biological tissue while in contact with it. The treatment unit comprises: a main body portion that transfers the energy to the biological tissue; and a covering film, which is primarily composed of organosilicon and covers the surface of the main body portion. In the organosilicon, the molar ratio of silicon atoms forming D units to all silicon atoms is 40% or more and 99% or less, and the molar ratio of methyl groups bonded to silicon atoms to all functional groups bonded to silicon atoms is 60% or more.

[0014] A method for manufacturing a treatment section of a medical energy device according to a second aspect of the present invention, wherein the treatment section of the medical energy device, in a state of contact with biological tissue, transfers energy to the biological tissue and treats the biological tissue, the method comprising the following steps: preparing a main body and a coating liquid containing organosilicon, wherein the main body transfers the energy to the biological tissue, wherein the molar ratio of silicon atoms forming D units in the organosilicon to all silicon atoms is 40% or more and 99% or less, and the molar ratio of methyl groups bonded to silicon atoms to all functional groups bonded to silicon atoms is 60% or more; applying the coating liquid to the surface of the main body; and hardening the applied coating liquid by heating it to form a cover film, wherein the cover film, with the organosilicon as the main component, covers the surface of the main body.

[0015] The third-party medical energy device of the present invention has a treatment unit of the first type.

[0016] Invention Effects

[0017] According to the treatment section of the medical energy device of the first embodiment, the manufacturing method of the treatment section of the medical energy device of the second embodiment, and the third-party medical energy device, the durability during repeated treatment processes can be improved. Attached Figure Description

[0018] Figure 1 This is a schematic perspective view showing an example of the treatment section of a medical energy device according to an embodiment of the present invention.

[0019] Figure 2 This is a schematic cross-sectional view of the treatment section of a medical energy device according to an embodiment of the present invention.

[0020] Figure 3 This is a schematic cross-sectional view illustrating the function of the treatment section of a medical energy device according to an embodiment of the present invention. Detailed Implementation

[0021] Hereinafter, the treatment section of a medical energy device according to an embodiment of the present invention and its manufacturing method will be described with reference to the accompanying drawings.

[0022] Figure 1 This is a schematic perspective view showing an example of the treatment section of a medical energy device according to an embodiment of the present invention. Figure 2 This is a schematic cross-sectional view of the treatment section of a medical energy device according to an embodiment of the present invention.

[0023] Figure 1 The medical energy device 101 shown in this embodiment is an example of a medical device that treats biological tissue by transferring energy to it while in contact with it.

[0024] As for the type of treatment, any treatment that involves transferring energy to the biological tissue in contact with it is acceptable; there are no particular limitations. Examples of treatments include cutting, excision, coagulation (hemostasis), and cauterization of biological tissue. Such treatments are achieved, for instance, by raising the temperature of the biological tissue to a level that causes the water in the tissue to evaporate or the proteins to denature.

[0025] To bring biological tissues to a high-temperature state, the type of energy transferred to them is not particularly limited. Examples of energy types include electrical energy, ultrasonic vibration energy, and thermal energy. The energy transferred to biological tissues is not limited to one type; multiple types of energy can be transferred.

[0026] Specific types of medical energy devices include, for example, high-frequency knives, high-frequency scissor knives, electrosurgical knives, snares, ultrasonic coagulation and cutting devices, high-frequency cauterization devices, high-frequency / ultrasonic hybrid devices, and heating and cauterization heaters.

[0027] The medical energy device 101 includes a retainer 9, a processing unit 1, and a power supply 10.

[0028] The retainer 9 is a component that supports the treatment unit 1. The retainer 9 may, for example, be shaped so that a surgeon can hold it by hand. The retainer 9 may, for example, be shaped so that a medical robot can hold it. The retainer 9 may, for example, be fixed to a medical robot. The retainer 9 is positioned outside the patient's body and is used so that it does not come into contact with the biological tissue of the treatment object.

[0029] exist Figure 1 In the example shown, retainer 9 is formed in a rod shape so that it can be held by the surgeon or medical robot.

[0030] The treatment unit 1 has a suitable shape that enables it to deliver the energy required for treatment while in contact with biological tissue.

[0031] exist Figure 1 In the example shown, the processing unit 1 can transmit one or both of ultrasonic vibration energy and high-frequency electrical energy to biological tissue.

[0032] The processing unit 1 has a support member 4, a first gripping part 2, and a second gripping part 3.

[0033] The support member 4 is fixed to the end of the retainer 9. In this embodiment, the support member 4 is a rod-shaped member.

[0034] The shape of the support member 4 is not particularly limited. As an example, Figure 1 The support member 4 shown is a quadrangular prism with four sides 4b along its extending direction. A wiring 10a, connected to the power supply 10 (described later), is inserted inside the support member 4. The wiring 10a extends from the end of the retainer 9 to the outside of the retainer 9. The length of the support member 4 is such that, with the retainer 9 held outside the patient's body, the treatment unit 1 can be positioned inside the patient's body near the treatment object.

[0035] The support member 4, located near the first gripping portion 2 and the second gripping portion 3 (described later), may experience a temperature rise due to heat conduction from the first gripping portion 2 and the second gripping portion 3. The support member 4 near the first gripping portion 2 and the second gripping portion 3 may come into contact with the biological tissue of the object being treated. Therefore, it is preferable that at least the vicinity of the first gripping portion 2 and the second gripping portion 3 on each side 4b of the support member 4 is covered with an adhesion-preventing film to prevent the adhesion of biological tissue.

[0036] In this embodiment, such as Figure 2 As shown in the cross-sectional structure near side 4b, the support member 4 includes a substrate 40 (main body) and a covering film 5.

[0037] The substrate 40 may be formed of any material, such as metal, ceramic, resin and composite materials thereof.

[0038] Examples of metals suitable for use in substrate 40 include stainless steel, aluminum, aluminum alloys, titanium, and titanium alloys.

[0039] Examples of ceramics suitable for substrate 40 include aluminum nitride, silicon nitride, and aluminum oxide.

[0040] The cover film 5 of the support member 4 covers the surface 40a of the substrate 40. The detailed structure of the cover film 5 will be described after the description of the processing part 1.

[0041] like Figure 1As shown, a rotating support portion 4a is provided between the side surfaces 4b facing each other at the ends of the supporting member 4 in the extending direction and the second gripping portion 3 described later. The rotating support portion 4a provides rotating support for the second gripping portion 3 about an axis orthogonal to the extending direction.

[0042] The structure of the rotating support part 4a is not particularly limited as long as it can provide rotating support for the second gripping part 3 described later. For example, the rotating support part 4a may also include a rotating shaft or a bearing.

[0043] Although not shown in the figure, an operating component that controls the rotation of the second gripping part 3 (described later) is inserted inside the support member 4. The operating component extends into the retaining member 9 and connects to the operating part of the retaining member 9 (not shown in the figure). For example, an operating line or operating lever that moves forward and backward along the length of the support member 4 can also be used as the operating component.

[0044] One or both of the first gripping part 2 and the second gripping part 3 are fixed to the support member 4 in a manner that allows them to move relative to each other, so that the biological tissue can be held during the disposal of the biological tissue.

[0045] exist Figure 1 In the example shown, the first gripping part 2 is a rod-shaped body that protrudes forward from the front end of the support member 4. The base end of the first gripping part 2 in the long side direction is fixed to the support member 4 with a piezoelectric element disposed in the support member 4 clamped in between.

[0046] The piezoelectric element is a vibration source that causes the first gripping part 2 to vibrate ultrasonically. The piezoelectric element is electrically connected to the vibration control terminal of the power supply 10 via wiring 10a. A drive signal for causing the piezoelectric element to vibrate ultrasonically is supplied from the vibration control terminal of the power supply 10, which will be described later.

[0047] The second gripping part 3 is supported by the rotating support part 4a of the support member 4 so that it can rotate.

[0048] In this embodiment, the first gripping part 2 and the second gripping part 3 are electrically connected to the high-frequency output terminal of the power supply 10 (described later) via wiring 10a. High-frequency electricity for high-frequency treatment of biological tissue in contact with the first gripping part 2 and the second gripping part 3 is supplied from the high-frequency output terminal through the first gripping part 2 and the second gripping part 3.

[0049] The surface of the first gripping part 2 is composed of a first gripping surface 2a that contacts the biological tissue and an outer surface 2b other than the first gripping surface 2a.

[0050] The shape of the first gripping part 2 is not particularly limited. In this embodiment, as an example, the first gripping part 2 is a pentagonal prism with a convex pentagonal shape that is pushed out in the extending direction. The first gripping surface 2a is composed of two side surfaces that extend in the extending direction of the pentagonal prism and are adjacent to each other in the circumferential direction. Each first gripping surface 2a forms a protrusion with a triangular cross-section extending in the extending direction.

[0051] Figure 2 This shows the cross-sectional structure near the first gripping surface 2a and the outer surface 2b. The first gripping part 2 includes a substrate 20 (main body) and a cover film 5.

[0052] The substrate 20 can be formed of any material, such as metal, ceramic, or composite materials. For example, if the substrate 20 is made of ceramic, it is more preferable that the first gripping part 2 also includes a metal electrode (not shown) covered by the substrate 20.

[0053] Examples of metals suitable for use in substrate 20 include stainless steel, aluminum, aluminum alloys, titanium, and titanium alloys.

[0054] Examples of ceramics suitable for use with substrate 20 include aluminum nitride, silicon nitride, and aluminum oxide.

[0055] The wiring 10a connected to the high-frequency output terminal is connected to the substrate 20 when the substrate 20 is metal, and connected to the metal electrode when the non-metallic substrate 20 covers the metal electrode.

[0056] The cover film 5 in the first gripping part 2 covers the surface 20a of the substrate 20. The detailed structure of the cover film 5 will be described after the description of the processing part 1.

[0057] like Figure 1 As shown, the second gripping part 3 is a rod-shaped body provided between the first gripping surface 2a of the first gripping part 2 for the purpose of gripping biological tissue.

[0058] A connecting portion 3c is formed at the end of the second gripping portion 3 in the length direction.

[0059] The connecting part 3c is rotatably connected to the rotating support part 4a of the support member 4. For example, if the rotating support part 4a has a rotating shaft, the connecting part 3c may be composed of a groove, hole, bearing, etc., that can rotate around the rotating shaft. For example, if the rotating support part 4a has a bearing, the connecting part 3c may be composed of a shaft, protrusion, etc., that engages with the bearing.

[0060] In this embodiment, the connecting part 3c and the rotating support part 4a are electrically insulated from each other.

[0061] Although the illustration is omitted, a connecting portion that connects to the aforementioned operating component is formed near the connecting portion 3c. For example, when the operating component moves forward or backward, the connecting portion transmits the movement of the operating component to the second gripping portion 3. The second gripping portion 3 rotates about the rotation support portion 4a by the torque of the operating force acting on the connecting portion.

[0062] At least one of the operating components and the connecting parts is not electrically connected to the wiring 10a connected to the second gripping part 3.

[0063] The shape of the second gripping part 3 is not particularly limited, as long as it can grip the object being processed between the first gripping part 2 and the second gripping part 3. Figure 1 In the example shown, the second gripping part 3 is a rod-shaped body with the same length as the first gripping part 2.

[0064] The surface of the second gripping part 3 is composed of a second gripping surface 3a that contacts the object being processed and an outer surface 3b other than the second gripping surface 3a.

[0065] The second gripping surface 3a is composed of two adjacent planes. The second gripping surface 3a forms a V-groove extending along the length direction of the second gripping part 3.

[0066] In this embodiment, the V-groove is a concave shape corresponding to the convex shape formed by the first gripping surface 2a of the first gripping part 2. When the second gripping part 3 is rotated to become parallel to the first gripping part 2 (hereinafter referred to as the closed state), each second gripping surface 3a is parallel to each first gripping surface 2a of the first gripping part 2. In the closed state, the distance between the opposing first gripping surfaces 2a and second gripping surfaces 3a is not particularly limited as long as it is 0 mm or more and smaller than the thickness of the object being processed.

[0067] However, when the second gripping part 3 is brought close to the first gripping part 2 by rotation, as long as the first gripping surface 2a can enter the interior of the V-groove, the angle formed by each first gripping surface 2a and the angle formed by each second gripping surface 3a can be different from each other.

[0068] like Figure 2 As shown in the cross-sectional structure near the second gripping surface 3a and the outer surface 3b, the second gripping part 3 includes a substrate 30 (main body) and a cover film 5.

[0069] The substrate 30 can be formed of any material, such as metal, ceramic, or composite materials. For example, if the substrate 30 is made of ceramic, it is more preferable that the second gripping part 3 also includes a metal electrode (not shown) covered by the substrate 30.

[0070] Examples of metals and ceramics that can be used for substrate 30 are the same as those for substrate 20 described above.

[0071] The wiring 10a connected to the high-frequency output terminal is connected to the substrate 30 when the substrate 30 is metal, and connected to the metal electrode when the non-metallic substrate 30 covers the metal electrode.

[0072] The cover film 5 in the second gripping part 3 covers the surface 30a of the substrate 30. The detailed structure of the cover film 5 will be described after the description of the processing part 1.

[0073] like Figure 1 As shown, the power supply 10 is electrically connected to the processing unit 1 via wiring 10a. The power supply 10 has a vibration control terminal, a high-frequency output terminal, and a power supply circuit that outputs electrical signals to them. A drive signal is output to the vibration control terminal to cause the piezoelectric element connected to the first gripping unit 2 to perform ultrasonic oscillation. A high-frequency electrical signal to be applied to the first gripping unit 2 and the second gripping unit 3 is output to the high-frequency output terminal.

[0074] In the treatment unit 1, the first gripping part 2 and the second gripping part 3 are examples of main parts for transferring energy to biological tissue. The support member 4 is not intended to transfer energy to biological tissue, but it becomes an example of a main part when it comes into contact with biological tissue during treatment and it is possible to transfer energy.

[0075] Next, the covering film 5 will be explained.

[0076] The covering membrane 5 is mainly provided to inhibit the adhesion of biological tissue to the treatment section 1. The covering membrane 5 can be provided on any part or part of the treatment section 1 that may come into contact with biological tissue.

[0077] like Figure 2 As shown, in this embodiment, the covering film 5 is formed at least on the first gripping surface 2a and outer surface 2b of the first gripping part 2, the second gripping surface 3a and outer surface 3b of the second gripping part 3, and the side surface 4b of the support member 4.

[0078] The cover film 5 is mainly composed of silicone. The cover film 5 covers the surfaces of substrates 20, 30, and 40.

[0079] Silicones have excellent water repellency and heat resistance, and are therefore sometimes used as anti-adhesion films on the surfaces of treated areas. However, it is known that their treatment performance gradually decreases with repeated treatments.

[0080] According to the inventors' observations, in the treatment section where the processing performance deteriorates, biological tissue adheres to the areas where the silicone film cracks or peels off from the main body. This degradation is particularly noticeable when the temperature of the silicone film reaches 300°C or higher. The inventors believe that the cracking and peeling of the silicone film are caused by internal stress, which arises from the difference in the coefficients of thermal expansion between the main body and the silicone film. Through in-depth research on methods to alleviate internal stress, a novel mitigation method was discovered, leading to the completion of this invention.

[0081] Organosilicones are organosilicon compounds with siloxane bonds as the main backbone. Organosilicones are formed by combinations of M units, D units, T units, and Q units.

[0082] In the M unit, for each silicon atom, there is one oxygen atom and three functional groups bonded together. The functional groups in the M unit share oxygen atoms with adjacent units; therefore, R is treated as an organic functional group, represented as R3SiO. 1 / 2 .

[0083] In unit D, one silicon atom is bonded to two oxygen atoms and two functional groups. The functional group of unit D is represented as R₂SiO₃. 2 / 2 .

[0084] In a T-unit, one silicon atom is bonded to three oxygen atoms and one functional group. The functional group of the T-unit is represented as R1SiO. 3 / 2 .

[0085] In the Q unit, one silicon atom is bonded to four oxygen atoms. The atomic group of the Q unit is represented as SiO. 4 / 2 .

[0086] By including a methyl group (CH3-) as a functional group, the water repellency becomes significantly improved, thus enhancing the resistance to adhesion to biological tissues. A phenyl group (C6H5-) is also preferred as a functional group.

[0087] For example, other functional groups may include ethyl, propyl, amino, etc.

[0088] Organosilicon's properties change as a whole by bonding M, D, T, and Q units in various proportions. Specifically, an oxygen atom is shared by two silicon atoms, thus becoming the "hand" connecting the two silicon atoms. Therefore, a Q unit has four hands, a T unit has three hands, a D unit has two hands, and an M unit has one hand. For example, with more Q units, each Q unit has four hands, thus a 3D mesh structure becomes dominant, resulting in a hard solid resin. In contrast, when multiple D units are bonded together, since each D unit has two hands, a linear structure is formed. This linear structure extends in a helical shape without branching midway, thus exhibiting elasticity and flexibility.

[0089] Therefore, even in silicone resins that have a 3D network structure as a whole, the proportion of linear structures in the D-unit-rich regions is higher than that in the Q-unit-rich regions, resulting in excellent stretchability and flexibility.

[0090] In this embodiment, in the organosilicon contained in the cover film 5, the molar ratio of silicon atoms forming D units to all silicon atoms in the organosilicon is 40% or more and 99% or less, and the molar ratio of methyl groups bonded to silicon atoms to all functional groups bonded to silicon atoms in the organosilicon is 60% or more (the molar ratio of methyl groups is related to the anti-adhesion performance).

[0091] For simplicity, the molar ratio of silicon atoms forming D units to all silicon atoms in organosilicon will be referred to as the "D unit composition molar ratio". The "D unit composition molar ratio" represents the ratio of the number of silicon atoms forming D units to the total number of silicon atoms in organosilicon. Similarly, the molar ratio of silicon atoms forming T units to all silicon atoms in organosilicon will be referred to as the "T unit composition molar ratio".

[0092] In organosilicon compounds, the molar ratio of methyl groups bonded to silicon atoms to all functional groups bonded to silicon atoms is called the "methyl molar ratio." The "methyl molar ratio" represents the ratio of the number of methyl groups to the total number of functional groups bonded to all silicon atoms in the organosilicon.

[0093] The molar ratio of unit component D can be measured, for example, by measuring the molar ratio of the sample covering film 5. 29 The result is obtained using Si-NMR (nuclear magnetic resonance) spectroscopy.

[0094] The methyl molar ratio can be measured, for example, by measuring the molar ratio of the sample covered with film 5. 13 C-NMR spectra and 1 It can be determined by H-NMR spectroscopy.

[0095] If the molar ratio of D unit components is less than 40%, the number of silicon atoms forming T and Q units will increase, and the extensibility and flexibility of the covering film 5 will decrease. Therefore, it is prone to cracking and peeling due to thermal stress generated by repeated processing.

[0096] A higher molar ratio of D-unit components is preferred. For example, the molar ratio of D-unit components can be 60% or more. However, when the molar ratio of D-unit components is 100%, the hardness of the capping film 5 is low, and it may be damaged during processing. For example, experiments conducted by the inventors of this application have shown that even with a 100% molar ratio of D-unit components in polydimethylsiloxane, the hardness of the capping film 5 is insufficient. Furthermore, no cases of insufficient hardness of the capping film 5 have been found in other organosilicon products with high molar ratios of D-unit components. Therefore, a molar ratio of D-unit components of 40% or more and 99% or less can be considered an appropriate range.

[0097] When the molar ratio of D unit components is above 40%, which is considered appropriate, polydimethylsiloxane needs to be removed.

[0098] If the methyl molar ratio is less than 60%, the water repellency of the covering film 5 decreases, and therefore the anti-adhesion performance of the covering film 5 against biological tissue adhesion itself decreases.

[0099] A higher methyl molar ratio is preferred. For example, the methyl molar ratio can be above 90%.

[0100] From the perspective of easily reducing the internal stress of the cover film 5, a thinner film thickness is preferred. For example, a film thickness of 60 μm or less is more preferred for the cover film 5.

[0101] If the thickness of the cover membrane 5 exceeds 60 μm, the internal stress changes caused by the repeated temperature differences accompanying the treatment become larger, thus the cover membrane 5 is prone to deterioration.

[0102] There is no particular limitation on the lower limit of the thickness of the cover film 5 in terms of reducing changes in internal stress. For example, the thickness of the cover film 5 can also be 1 nm or more.

[0103] From the viewpoint that it is easier to manufacture the cover film 5, the thickness of the cover film 5 is more preferably 10 μm or more.

[0104] From the viewpoint of easily ensuring the insulation of the cover film 5, the thickness of the cover film 5 is more preferably 20 μm or more.

[0105] When the silicone membrane monomer is formed to a thickness greater than 20 μm as the cover film 5, it is impossible to pass high-frequency electricity from the treatment section 1 to the biological tissue. However, as the cover film 5, by forming the silicone membrane to a thickness of 20 μm or less, or by incorporating conductive fillers into the silicone membrane, it is possible to pass high-frequency electricity from the treatment section 1 to the biological tissue.

[0106] For example, when hemostasis is achieved by high-frequency energization, scorching may occur on the surface of the biological tissue being held in the treatment section 1. However, by forming the silicone membrane monomer into a film of 20 μm or less, or by incorporating conductive fillers into the silicone, scorching during treatment can be prevented even when the covering film 5 is used on the holding side of the treatment section 1.

[0107] Therefore, especially in the processing section 1 where a process requiring high-frequency energization is performed, it is more preferable that the cover film 5 covering at least the first gripping surface 2a and the second gripping surface 3a is formed of an organosilicon film containing conductive fillers or an organosilicon film with a thickness of 20 μm or less that does not contain conductive fillers.

[0108] Examples of conductive fillers suitable for use in the cover film 5 include copper, silver, aluminum oxide, tungsten, and carbon.

[0109] Furthermore, according to the inventors' experiments, in order to obtain good conductivity, it is preferable that the volume ratio of conductive filler in the overall covering film 5 is more than 40% and less than 90%.

[0110] Conductive fillers can be mixed into the interior of the cover film 5, or they can be applied to the surface of the silicone film by coating or other means after the silicone film is formed, thereby being disposed on the surface of the cover film 5.

[0111] The covering membrane 5 may also contain hollow filler. In this case, the thermal insulation of the covering membrane 5 can be improved. For example, the material of the hollow filler may be alumina, silica, alumina borosilicate glass, sodium borosilicate, aminosilicate glass, soda lime borosilicate glass, etc. For example, the hollow filler may also be a conductive filler.

[0112] The shape and hollowness of the hollow filler are not particularly limited, as long as they can achieve the thermal insulation performance required by the covering membrane 5.

[0113] For example, during treatment, if the outer surfaces 2b and 3b of the treatment section become too hot, the biological tissue may be damaged because the hot parts of the outer surfaces 2b and 3b come into contact with organs and other biological tissues.

[0114] If the covering film 5 has good heat insulation properties, the heat generated during treatment is difficult to be transferred to the back side of the treatment section 1, etc., thus preventing damage to organs, etc. caused by heat.

[0115] If the ratio of the volume of the vacant space to the volume of the covering membrane 5 is defined as the vacancy rate, then, for example, when the vacancy rate is above 20% and below 90%, the covering membrane 5 has good thermal insulation properties.

[0116] When the hollow ratio is less than 20%, the thermal insulation may become insufficient; when the hollow ratio exceeds 90%, the strength of the membrane may be insufficient.

[0117] Instead of containing hollow filler in the covering membrane 5, air bubbles can be dispersed within the covering membrane 5 to form hollow spaces inside the covering membrane 5. In this case, the hollowness ratio can be 20% or more and 90% or less.

[0118] When the thermal insulation of the cover membrane 5 is improved by adding hollow fillers or forming hollow spaces, it is preferable that the cover membrane 5 has a thicker film. For example, the film thickness of the cover membrane 5 is preferably 50 μm or more.

[0119] For example, if a silicone resin is coated onto the ultrasonic vibrating part in the treatment section 1 that contacts the object to be treated and transmits ultrasonic vibrations to the object to be treated to form a cover film, the cover film may be damaged because it cannot follow the ultrasonic vibrations.

[0120] However, as will be described later, the silicone, which is the main component of the cover film 5 in this embodiment, contains more D units and is therefore more flexible than silicone resin. Therefore, compared to silicone resin films, the cover film 5 in this embodiment is more likely to follow ultrasonic vibrations even when subjected to ultrasonic waves, thus making it less susceptible to damage and improving its durability.

[0121] Therefore, the covering film 5 of this embodiment is particularly suitable for the treatment unit 1 that performs ultrasonic vibration.

[0122] Next, the manufacturing method of the processing unit 1 of the medical energy device of this embodiment will be described.

[0123] To manufacture the processing unit 1, a cover film 5 is formed on each surface of the substrates 20, 30, and 40, forming a first gripping part 2, a second gripping part 3, and a support member 4. Then, the processing unit 1 is manufactured by assembling the first gripping part 2, the second gripping part 3, and the support member 4.

[0124] The process of forming the cover film 5 on substrates 20, 30, and 40 is the same, so the following description will use the example of forming the cover film 5 on substrate 20. Regarding the manufacturing method of the second gripping part 3 and the support member 4, it is only necessary to replace the substrate 20 and surface 20a below with substrates 30 and 40 and surfaces 30a and 40a, respectively.

[0125] In the manufacturing process of the first gripping part 2, the processes related to the cover film 5 include a preparation process, a coating process, and a hardening process.

[0126] In the preparation process, a substrate 20 and a coating liquid for forming a cover film 5 are prepared.

[0127] In this process, the surface 20a of the prepared substrate 20 is formed into the shape of the first holding portion 2 after removing the covering film 5.

[0128] The coating liquid contains at least one organosilicon that forms the polymer. As the at least one organosilicon, a material is selected that has a D-unit molar ratio of 40% or more and a methyl molar ratio of 60% or more during polymerization.

[0129] That is, considering the reduction in D units during the polymerization reaction, the molar ratio of D unit components in the overall organosilicon contained in the coating solution is greater than 40%. Similarly, considering the reduction in methyl groups during the polymerization reaction, the molar ratio of methyl groups in the overall organosilicon contained in the coating solution is greater than 60%.

[0130] The molar ratio of D-unit components in the coating solution can be determined, for example, by measuring a sample of the coating solution. 29 The result is obtained using Si-NMR (nuclear magnetic resonance) spectroscopy.

[0131] The methyl molar ratio in the coating solution can be measured, for example, by measuring the sample of the coating solution. 13 C-NMR spectra and 1 It can be determined by H-NMR spectroscopy.

[0132] When the coating solution contains multiple organosilicones, the amount of D-units and methyl groups in the organosilicones can be adjusted by mixing the multiple organosilicones in an appropriate ratio. As long as the required amount of D-units and methyl groups after curing can be obtained, there is no particular limitation on the amount of D-units and methyl groups in the multiple organosilicones.

[0133] For example, various organosilicones can contain a first organosilicon with a large molar ratio of D-unit components in its molecule, and a second organosilicon with a smaller molar ratio of D-unit components compared to the first organosilicon. In this case, the amount of D-units after curing can be easily controlled by utilizing the mixing ratio of the first organosilicon and the second organosilicon.

[0134] As long as the overall methyl molar ratio in the polymer is 60% or more, there is no particular limitation on the magnitude of the methyl molar ratio in the molecules of the first and second organosilicones. From the viewpoint of easily increasing the methyl molar ratio, it is preferable that the first organosilicon contains methyl groups, and more preferably that both the first and second organosilicones contain methyl groups.

[0135] As the first organosilicon, any organosilicon with a high number of D units is acceptable, and there are no particular limitations. For example, polydiorganosiloxane can be used as the first organosilicon. Considering the ease with which the methyl content in the capping film 5 can be increased, polydimethylsiloxane is more preferably used as the first organosilicon.

[0136] As a second organosilicon, it is an organosilicon with a smaller molar ratio of D units in its molecule compared to the first organosilicon, and it is not particularly limited as long as it contains T units. For example, the second organosilicon may not contain D units. For example, the second organosilicon may also contain Q units.

[0137] For example, a polyorganosiloxane with a large molar ratio of silicon atoms forming T units in the silicon atoms of the molecule can be used as the second organosilicon. For example, organosilicon resins can also be used as the second organosilicon. From the viewpoint of easily increasing the methyl content in the capping film 5, the main component of the functional group of the second organosilicon is more preferably methyl.

[0138] In addition to silicone, the coating liquid may also contain solvents, pigments, viscosity modifiers, additives that polymerize silicone, conductive fillers, hollow fillers, etc.

[0139] Examples of additives that enable the polymerization of organosilicon include polymerization initiators and pH adjusters.

[0140] Examples of polymerization initiators include polymerization catalysts such as titanium alkoxides and tin compounds.

[0141] Examples of pH adjusters include hydrochloric acid and sodium hydroxide.

[0142] After the preparation process, the coating process is carried out.

[0143] In the coating process, the coating liquid is applied to the surface 20a of the substrate 20. More preferably, the coating amount is such that the film thickness upon curing is 60 μm or less.

[0144] There are no particular limitations on the coating method. For example, coating methods include spray coating, dip coating, spin coating, brush coating, and vacuum evaporation.

[0145] After the coating process, a hardening process is carried out.

[0146] In the curing process, the coating liquid applied to surface 20a is heated to harden it. The heating method and conditions are not particularly limited as long as they enable the polymerization reaction of the organosilicon in the coating liquid to form the covering film 5. For example, heating can be performed at a low temperature below the polymerization initiation temperature to allow the solvent to evaporate, and then heated to above the polymerization initiation temperature.

[0147] The above describes the process of forming the cover film 5 in the first gripping part 2. Similarly, the second gripping part 3 can be manufactured by forming the cover film 5 on the surface 30a of the substrate 30, and the support member 4 can be manufactured by forming the cover film 5 on the surface 40a of the substrate 40.

[0148] With the wiring 10a connected to the first gripping part and the second gripping part 3 and the operating components connected, the first gripping part and the second gripping part 3 are fixed to the support member 4 and the retaining member 9. The processing part 1 is thus manufactured.

[0149] Next, the function of the treatment unit 1 will be explained with a focus on the function of the covering film 5.

[0150] The medical energy device 101, for example, can transmit one or both of ultrasonic vibration energy and high-frequency electrical energy to a biological tissue while the biological tissue is held by the first gripping part 2 and the second gripping part 3.

[0151] For example, when a drive signal is supplied to the piezoelectric element from the power source 10 through wiring 10a, the piezoelectric element vibrates ultrasonically. When the first gripping part 2 vibrates ultrasonically, the ultrasonic vibration is transmitted to the biological tissue that abuts against the first gripping part 2. The biological tissue is heated by frictional heat in the contact area between the second gripping part 3 and the biological tissue.

[0152] For example, a high-frequency current flows from the power source 10 through wiring 10a to the biological tissue between the first gripping part 2 and the second gripping part 3, generating Joule heating. Thus, the biological tissue is heated.

[0153] Thus, when biological tissue is heated by one or both of ultrasonic vibration and high-frequency current, the water in the tissue evaporates rapidly, and the proteins denature. This results in the tissue being cauterized. If blood is flowing in the tissue, hemostasis is achieved at the cauterized area. If the goal is hemostasis, heating is stopped while the tissue is still hemostatic.

[0154] For example, if the purpose of the treatment is to cut, further heating is continued. The burned biological tissue becomes brittle, and the fragile parts are cut off by pressure from the first gripping part 2 and the second gripping part 3.

[0155] To facilitate rapid treatment, it is necessary to maximize the temperature of the biological tissue being treated. For example, while the temperature of the biological tissue has traditionally been around 200°C, a temperature of 300°C or higher is more preferable for faster treatment. In this case, the temperature of the treatment section 1, which comes into contact with the biological tissue, is also 300°C or higher.

[0156] The main component of the covering film 5 is a polymer of organosilicon, and therefore it is a solid film containing a 3-dimensional mesh structure formed by strong siloxane bonds.

[0157] The covering film 5 contains methyl groups with excellent water repellency at a molar ratio of more than 60% as functional groups in organosilicon, thus exhibiting excellent performance in preventing the adhesion of biological tissues.

[0158] The thermal decomposition temperature of siloxane bonds is high, thus the capping film 5 exhibits excellent heat resistance. For example, in the case of a monomer, the capping film 5 can be used as long as the temperature is below 400°C.

[0159] However, the covering film 5 is formed on a substrate 20 made of a metal, ceramic, or similar material with a coefficient of thermal expansion smaller than that of silicone. During repeated treatments, the covering film 5 is subjected to repeated thermal stresses depending on its coefficient of thermal expansion. The higher the temperature of the biological tissue during treatment, the greater the thermal stress.

[0160] Therefore, the following problems have existed in the past: even at temperatures lower than the heat resistance temperature of silicone, silicone will deteriorate with repeated treatments, and the coating film of the treated area will crack and peel off.

[0161] Figure 3 This is a schematic cross-sectional view illustrating the function of the treatment section of a medical energy device according to an embodiment of the present invention.

[0162] In this embodiment, the molar ratio of D-units in the organosilicon polymer, which is the main component of the covering film 5, is 40% or more. Therefore, a linear structure in which multiple D-units are bonded to each other is formed between the Q-unit-rich areas. The linear structure in which the D-units are bonded to each other extends in a spiral shape, thus exhibiting superior stretchability and flexibility compared to a 3D mesh structure mainly composed of Q-units.

[0163] Therefore, as Figure 3 As schematically shown in (a), the covering membrane 5 has a membrane structure in which a plurality of relatively soft portions 5A containing more D portions are sandwiched between a plurality of relatively hard portions 5B, which are mainly composed of Q units.

[0164] For example, during treatment, the temperature of the treatment section 1 rises along with the biological tissue of the object being treated, causing thermal expansion of the cover film 5 and the substrate 20. Internal stress is generated in the cover film 5 based on the difference in the coefficients of thermal expansion of the silicone materials of the substrate 20 and the cover film 5.

[0165] However, as Figure 3 As illustrated in (b), when the temperature rises, the softer part 5A with a larger molar ratio in unit D is more easily deformed than the harder part 5B, thus easing internal stress. As a result, the internal stress caused by the temperature rise is eased as a whole in the covering film 5, thereby suppressing cracks, peeling, etc. caused by repeated thermal stress.

[0166] The thinner the cover film 5, the better it can suppress the changes in internal stress caused by repeated thermal expansion. Therefore, by making the cover film 5 as thin as possible, the durability of the cover film 5 can be further improved.

[0167] As explained above, the treatment unit 1 and the medical energy device 101 according to this embodiment can improve the durability of repeated treatments.

[0168] Furthermore, in the description of the above embodiments, an example of a treatment unit used in a medical energy device capable of transmitting one or both of ultrasonic vibrations and high-frequency electrical energy to biological tissues was given. However, the energy used to treat biological tissues is not limited to this.

[0169] For example, the treatment unit may only deliver ultrasonic vibrations or only high-frequency electrical energy to biological tissues.

[0170] For example, the treatment unit may also be equipped with heating devices such as heaters to transfer heat energy generated by the heating devices to biological tissues.

[0171] In the description of the above embodiments, an example was described where the treatment unit has a mechanism for holding biological tissue, and the biological tissue is held for treatment. However, the treatment unit may not have a mechanism for holding biological tissue. In this case, for example, the treatment unit may be formed into a rod-shaped, plate-shaped, or similar shape that can be pressed against biological tissue for treatment.

[0172] In the description of the above embodiments, an example was given where the shapes of the first gripping surface 2a and the second gripping surface 3a are composed of a combination of planes. However, the surface of the substrate covered by the cover film may also be a plane, a curved surface, or the like. The surface of the substrate covered by the cover film may also be a surface with a small amount of unevenness compared to the film thickness.

[0173] In the description of the above embodiments, an example was given in which the same covering film 5 was formed on the entire surface of the first gripping part 2, the second gripping part 3 and the support member 4 in the processing part 1.

[0174] However, the composition and thickness of the covering film 5 can be appropriately changed according to the temperature of each surface of the treatment section 1 and the possibility of contact with biological tissues.

[0175] In particular, compared to the first gripping part 2 and the second gripping part 3, the support member 4 is less likely to be pressed against the object being treated during use. Furthermore, the temperature of the support member 4 may be lower than that of the first gripping part 2 and the second gripping part 3. Therefore, the mechanical strength, heat resistance, and ability to prevent the adhesion of biological tissue of the support member 4 may sometimes be lower than those of the first gripping part 2 and the second gripping part 3.

[0176] Similarly, in the first gripping part 2 and the second gripping part 3, the material and thickness of the covering film 5 on the first gripping surface 2a and the second gripping surface 3a may be different from the composition and thickness of the covering film 5 on the outer surfaces 2b and 3b.

[0177] Furthermore, in the treatment section 1, the covering film 5 may not be formed on surfaces where the possibility of contact with biological tissue is low or at low temperatures. That is, it is sufficient that a covering film 5, with organosilicon as its main component having a molar ratio of D unit components of 40% or more and a molar ratio of methyl groups of 60% or more, is formed at least in the surface area in the treatment section 1 where the biological tissue will come into contact with it. In the surface areas of the treatment section 1 other than those covered by the covering film 5, the main body may be exposed, or a covering film that is not equivalent to the covering film 5 may be formed.

[0178] Example

[0179] Next, Examples 1 to 5, which are related to the implementation method, will be described together with Comparative Examples 1 and 2. The composition of the coating liquid, the structure of the covering film, and the evaluation results of Examples 1 to 5 and Comparative Examples 1 and 2 are shown in Table 1 below.

[0180] [Table 1]

[0181]

[0182] [Example 1]

[0183] Example 1 is an example corresponding to the processing unit 1 described above.

[0184] In Example 1, substrates 20, 30, and 40 formed into the shapes of a first gripping part 2, a second gripping part 3, and a support member 4, and a coating liquid for forming a cover film 5 were prepared.

[0185] For base materials 20, 30, and 40, SUS304 stainless steel is used.

[0186] As shown in [Table 1], the coating liquid is prepared by comprising a first organosilicon, a second organosilicon, and a polymerization initiator.

[0187] The first and second organosilicones are mixed because, by changing their respective proportions, coating solutions used in other embodiments with different D-unit molar ratios can be easily prepared.

[0188] As the first organosilicon, a polydiorganosiloxane with a D unit molar ratio of 100% is used. All functional groups of the first organosilicon are methyl (referred to as "methyl" in [Table 1]). The content of the first organosilicon is 100 parts by mass.

[0189] As the second organosilicon, a methyl / phenyl organosilicon resin containing methyl and phenyl as functional groups, with a T-unit component molar ratio of 100% (referred to as "methyl / phenyl" in "functional groups" of [Table 1]), was used. The content of the second organosilicon was 80 parts by mass.

[0190] As a polymerization initiator, 15 parts by mass of titanium alkoxide as a polymerization catalyst are added.

[0191] Then, the coating liquid is applied to the surfaces of substrates 20, 30, and 40 by spraying. The coating amount is set to achieve a film thickness of 80 μm upon curing.

[0192] Then, the substrates 20, 30, and 40 with the coating film were adjusted to 80°C and heated in a drying oven for 30 minutes to temporarily harden the coating film. Next, the substrates 20, 30, and 40 with the coating film were heated in a drying oven at 240°C for 1 hour. This promoted the polymerization of the first and second organosilicones, forming a cover film 5 with a thickness of 80 μm.

[0193] By assembling the first gripping part 2, the second gripping part 3, and the support member 4 thus formed, the processing part 1 of Embodiment 1 is manufactured.

[0194] [Examples 2-5]

[0195] Hereinafter, Examples 2 to 5 will be described focusing on their differences from Examples 1, etc.

[0196] In Example 2, except that the second organosilicon in the coating liquid is 40 parts by mass, the same covering film 5 as in Example 1 is formed.

[0197] In Example 3, except that all the functional groups of the second organosilicon in the coating liquid are methyl groups, the same covering film 5 as in Example 2 is formed.

[0198] In Example 4, except that the film thickness was changed to 20 μm by varying the amount of coating liquid, the same cover film 5 as in Example 3 was formed.

[0199] In Example 5, except that the second organosilicon in the coating liquid is 105 parts by mass, the same cover film 5 as in Example 4 is formed.

[0200] [Comparative Examples 1 and 2]

[0201] In Comparative Example 1, except that the second organosilicon in the coating liquid is 200 parts by mass, the same cover film as in Example 3 is formed.

[0202] In Comparative Example 2, except that the functional groups of the first organosilicon in the coating liquid are all phenyl and the functional groups of the second organosilicon are all methyl, the same covering film as in Example 1 is formed.

[0203] [Evaluation of the covering film]

[0204] The molar ratio of D-unit components (referred to as "molar ratio of silicon in D-units" in [Table 1]) and the molar ratio of methyl groups (referred to as "molar ratio of methyl groups" in [Table 1]) of each cover film of each embodiment and each comparative example were measured.

[0205] As a quantitative method for the molar ratio of D-unit components, a solid-state nuclear magnetic resonance spectrometer using a JNM-ECA400 (trade name: Nippon Electron Ltd.) was employed. 29 Si-NMR method. Specifically, obtaining and analyzing... 29 Si-NMR spectroscopy uses the molar ratio of D-unit components as the ratio of the peak area of ​​the D-unit to the total peak area for quantitative analysis.

[0206] As a quantitative method for the methyl molar ratio, and using JNM-ECA400 solid... 13 C-NMR method and solid 1 H-NMR method. Specifically, to obtain and analyze... 13 C-NMR spectra and 1 H-NMR spectroscopy quantifies the methyl molar ratio as the ratio of the peak area of ​​methyl groups to the peak areas of all functional groups bonded to silicon atoms.

[0207] [Evaluation of treatment performance]

[0208] After assembling each treatment unit of each embodiment and each comparative example as a medical energy device, a biological tissue cutting and treatment test was conducted.

[0209] The biological tissue being processed uses pig blood vessels.

[0210] Using the treatment unit, the pig's blood vessel is held with a force of 2N for 3 seconds to perform one incision. At this time, the relationship between the oscillation mode of ultrasonic vibration and high-frequency electricity and the temperature of the covering membrane is investigated in advance, and a signal with an oscillation mode based on the temperature of the covering membrane of 300°C is applied.

[0211] The above-described cutting action was repeated on the subject every 5 seconds. At the end of each cutting action, it was evaluated whether the blood vessels had been cut and whether biological tissue was attached to the treatment area.

[0212] The number of times until biological tissue adhered to the treatment section and the blood vessels were not cut was recorded as the number of cuts (refer to [Table 1]). In each embodiment and comparative example, there were no instances where biological tissue adhesion was not observed when the blood vessels were not cut. Therefore, it is believed that the decrease in the cutting performance of the treatment section was due to the adhesion of biological tissue.

[0213] Cases involving more than 50 cuts are defined as "good" (referred to as "A" in [Table 1]). Cases involving fewer than 50 cuts are defined as "not good" (referred to as "B" in [Table 1]).

[0214] [Evaluation Results]

[0215] As shown in [Table 1], the molar ratios of unit D components in Examples 1-5 are 50%, 73%, 73%, 73%, and 43%, respectively. The molar ratios of methyl groups in Examples 1-5 are 67%, 84%, 100%, 100%, and 60%, respectively.

[0216] In contrast, the molar ratios of D unit components in Comparative Examples 1 and 2 were 29% and 50%, respectively. The molar ratios of methyl groups in Comparative Examples 1 and 2 were 100% and 33%, respectively.

[0217] The number of cuts in Examples 1-5 were 50, 60, 80, 90, and 70, respectively.

[0218] In contrast, the number of cuts in Comparative Examples 1 and 2 were 20 and 10, respectively.

[0219] Based on the above evaluation results, the molar ratio of the D unit component in the cover film 5 of Examples 1 to 5 is all above 40% and below 99%, and the molar ratio of methyl is all above 60%.

[0220] The cutting performance of Examples 1 to 5 was all judged to be "good".

[0221] With the same film thickness, the larger the molar ratio of D unit components and the molar ratio of methyl groups, the more cuts are required. For example, comparing Examples 2 and 3, with the same film thickness and molar ratio of D unit components, Example 3, which has a larger molar ratio of methyl groups, requires more cuts.

[0222] For example, if comparing Examples 3 and 4, when the molar ratio of D unit components and the molar ratio of methyl are the same, Example 4, which has a thinner film, requires more cuts.

[0223] For example, if comparing Examples 1 and 5, even though the molar ratio of D unit components and the molar ratio of methyl in Example 5 are smaller than those in Example 1, Example 5, which has a thinner film, requires more cuts.

[0224] It is believed that if the membrane is thinner, the internal stress generated in the cover membrane 5 will be lower, thus making it less likely for cracks to form in the cover membrane, thereby improving the cutting performance.

[0225] In contrast, Comparative Examples 1 and 2 were both judged as "bad".

[0226] In Comparative Example 1, the film thickness and methyl molar ratio were the same as in Example 3, but the molar ratio of D unit components was less than 40%, thus significantly reducing the number of cuts.

[0227] In Comparative Example 1, the anti-adhesion effect provided by the methyl group was the same as in Example 3. However, it was considered that the insufficient number of D units resulted in low extensibility and flexibility of the cover film. Therefore, it was believed that repeated cutting would create cracks in the cover film, increasing the amount of biological tissue adhering to the cracks, thereby reducing the cutting performance.

[0228] In Comparative Example 2, the film thickness and molar ratio of D unit components were the same as in Example 1, but the methyl molar ratio was less than 60%, thus significantly reducing the number of cuts.

[0229] In Comparative Example 2, based on the molar ratio of the D unit components, it exhibits a certain degree of elasticity. However, the surface water repellency of the cover film is insufficient, thus the anti-adhesion performance is considered reduced.

[0230] Next, Examples 6-9, which are related to the implementation method, will be described together with Comparative Examples 3-5. Examples 6-9 and Comparative Examples 3-5 are examples and comparative examples in which the cover film 5 contains hollow filler. The evaluation based on Examples 6-9 and Comparative Examples 3-5 aims to evaluate the thermal insulation performance of the cover film containing hollow filler.

[0231] The following description focuses on the differences from Example 1.

[0232] The composition of the coating liquid, the structure of the covering film, and the evaluation results of Examples 6-9 and Comparative Example 3 are shown in Table 2 below.

[0233] It should be noted that, regarding the evaluation of the durability of the covering film, although not specifically shown, Examples 6-9 and Comparative Example 3, which have a molar ratio of D unit components of 40% or more and 99% or less and a molar ratio of methyl groups of 60% or more, all showed good performance.

[0234] [Table 2]

[0235]

[0236] [Examples 6-9]

[0237] In Example 6, a coating liquid containing 50 parts by mass of a second organosilicon, all functional groups of the first organosilicon being methyl, all functional groups of the second organosilicon being methyl, and 10 parts by mass of a hollow filler was used to form a coating film 5, otherwise the same as in Example 1. However, in Examples 6-9, the coating film 5 was formed at locations where biological tissue was not held during treatment, such as the outer surface 2b of the first holding portion 2 and the outer surface 3b of the second holding portion 3.

[0238] As the material for hollow fillers, inorganic materials based on alumina borosilicate glass are used.

[0239] In Example 7, except that the film thickness is 100 μm, the same cover film 5 as in Example 6 is formed.

[0240] In Example 8, except that the coating liquid is formed from 80 parts by weight of the second organosilicon, the same cover film 5 as in Example 6 is formed.

[0241] In Example 9, except that the hollow filler in the coating liquid is 45 parts by weight, the same covering film as in Example 8 is formed.

[0242] [Comparative Example 3]

[0243] In Comparative Example 3, except that the hollow filler in the coating liquid was 5 parts by mass, the same covering film as in Example 7 was formed.

[0244] [Comparative Example 4]

[0245] In Comparative Example 4, except that the second organosilicon in the coating liquid was 200 parts by mass, the same cover film as in Example 7 was formed.

[0246] [Comparative Example 5]

[0247] In Comparative Example 5, except that the hollow filler in the coating liquid was 50 parts by weight, the same cover film as in Comparative Example 4 was formed. However, in Comparative Example 5, the cover film was peeled off immediately after film formation.

[0248] [Evaluation of the covering film]

[0249] The molar ratio of D-unit components (referred to as "molar ratio of silicon in D-units" in Table 2) and the molar ratio of methyl groups (referred to as "molar ratio of methyl groups" in Table 2) of each cover film of Examples 6-9 and Comparative Examples 3-5 were measured in the same manner as in Example 1.

[0250] Furthermore, using a scanning electron microscope ERA-600FE (trade name: ELIONIX Co., Ltd.), the cross-sections of each covering film of Examples 6-9 and Comparative Examples 3-5 were observed, thereby measuring the hollowness.

[0251] Examples 6-9 and Comparative Examples 3-5 were intended to evaluate the thermal insulation performance of the cover film containing hollow filler, therefore quantitative evaluation of the treatment performance was omitted. However, when cutting was performed in Examples 6-9 and Comparative Example 3, even with hollow filler, the treatment performance showed performance corresponding to the molar ratio of the D unit components.

[0252] [Evaluation of thermal insulation performance]

[0253] After the treatment units of Examples 6-8 and Comparative Examples 3 and 4 were assembled as medical energy devices, the thermal insulation performance of the treatment units was tested as follows for the purpose of evaluating the thermal insulation performance of the covering film.

[0254] First, repeat the following process 500 times: bring the surface of the treatment area to 300°C using ultrasonic vibration and high-frequency electrical oscillation, then allow it to return to room temperature. Then, oscillate again until the surface of the treatment area reaches 300°C, stop oscillation, and immediately press the outer surface of the treatment area that is not holding the biological tissue, specifically the back part of the outer surface opposite the holding surface, onto the pig liver with a force of 2N for 3 seconds.

[0255] Then, the surface area of ​​the bleached (white wound) area was measured on the surface of the pig liver on the back side (pressing surface), and the ratio of the surface area of ​​the bleached area to the total area of ​​the pressing surface (the ratio of the white wound area) was calculated.

[0256] The percentage of white wound area is defined as "very good" (recorded as "A+" in Table 2), the percentage is defined as "good" (recorded as "A" in Table 2), and the percentage is defined as "not good" (recorded as "B" in Table 2).

[0257] [Evaluation Results]

[0258] As shown in [Table 2], the molar ratios of unit D components in Examples 6-9 are 62%, 62%, 50%, and 50%, respectively. The molar ratio of methyl groups in Examples 6-9 is 100%.

[0259] In contrast, the molar ratios of D unit components in Comparative Examples 3-5 were 62%, 30%, and 30%, respectively. The molar ratio of methyl groups in Comparative Examples 3-5 was 100%.

[0260] The hollow fractions of the covering film 5 in Examples 6-9 are 20%, 20%, 20%, and 90%, respectively.

[0261] In contrast, the hollowness of the covering films in Comparative Examples 3 to 5 were 10%, 20%, and 95%, respectively.

[0262] The percentages of white-skinned areas in Examples 6-9 were 9%, 5%, 50%, and 2%, respectively. Therefore, the thermal insulation performance of Examples 6, 7, and 9 was determined to be "very good," and the thermal insulation performance of Example 8 was determined to be "good."

[0263] In contrast, the white damage area ratio in Comparative Examples 3 and 4 was 80%. Therefore, the thermal insulation performance of Comparative Examples 3 and 4 was judged to be "poor".

[0264] In Comparative Example 5, the covering film peeled off before the evaluation began, making it impossible to evaluate the area of ​​white damage. Therefore, the thermal insulation performance was also judged as "poor".

[0265] Based on the above evaluation results, the molar ratio of the D unit component in the cover film 5 of Examples 6 to 9 is all above 40% and below 99%, and the molar ratio of methyl is all above 60%.

[0266] Regarding thermal insulation performance, in Examples 6 to 9 where the hollow area of ​​the covering film is 20% or more and 90% or less, the area of ​​white damage is judged as "very good" or "good".

[0267] The covering film 5 in Examples 6-9 has good heat insulation properties, so the heat transfer to the pig liver through the covering film is reduced, and the ratio of white wound area is small.

[0268] In contrast, in Comparative Example 3, the hollowness of the covering film was as low as 10%, resulting in reduced heat insulation performance and a white damage area assessment of "poor".

[0269] In Comparative Example 4, the hollowness of the cover film was 20%, but the area of ​​white damage was judged as "poor". The reason is that the molar ratio of silicon in the D unit was as low as 30%, so the durability of the cover film was reduced and the cover film was damaged.

[0270] It can be seen that if the hollowness of the covering membrane 5 is above 20% and below 90%, the heat insulation performance of the covering membrane 5 is improved, thus reducing heat transfer to biological tissues and inhibiting damage to biological tissues.

[0271] The preferred embodiments of the present invention have been described above together with the various examples, but the present invention is not limited to these embodiments or examples. Additions, omissions, substitutions, and other changes to the structure may be made without departing from the spirit of the present invention.

[0272] Furthermore, the present invention is not limited to the above description, but is defined only by the appended claims.

[0273] Industrial availability

[0274] According to the above embodiments, a treatment section of a medical energy device, a method for manufacturing the same, and the medical energy device can be provided, which can improve the durability of repeated treatments.

[0275] Marker description

[0276] 1. Disposal Department

[0277] 5. Covering film

[0278] 20, 30, 40 base materials (main body)

[0279] 101 Medical Energy Equipment

Claims

1. A treatment unit of a medical energy device, wherein the treatment unit, in contact with biological tissue, transfers energy to the biological tissue to treat the biological tissue, wherein... The processing unit of the medical energy device includes: The main body, which transmits the energy to the biological tissue; and A covering film, primarily composed of organosilicon, covers the surface of the main body. The organosilicon comprises at least D-units and T-units, wherein the molar ratio of silicon atoms forming the D-units to the total silicon atoms is more than 40% and less than 99%. Furthermore, in the organosilicon, the molar ratio of methyl groups bonded to silicon atoms to all functional groups bonded to silicon atoms is 60% or more. The covering film has a membrane structure in which a relatively soft portion is sandwiched between a plurality of relatively hard portions, which are mainly composed of Q units and are relatively hard, and the molar ratio of D units in the soft portion is higher than the molar ratio of D units in the hard portion.

2. The treatment unit of the medical energy device according to claim 1, wherein, In the organosilicon, the molar ratio of silicon atoms forming D units to all silicon atoms is 60% or more and 99% or less.

3. The treatment unit of the medical energy device according to claim 1, wherein, In the organosilicon, the molar ratio of methyl groups bonded to silicon atoms to all functional groups is 90% or more.

4. The processing unit of the medical energy device according to claim 1, wherein, The thickness of the covering film is less than 60 μm.

5. The treatment unit of the medical energy device according to claim 1, wherein, The covering film contains conductive filler.

6. The processing unit of the medical energy device according to claim 5, wherein, The covering film contains 40% to 90% of the conductive filler by volume.

7. The treatment unit of the medical energy device according to claim 1, wherein, The hollowness of the covering film is more than 20% and less than 90%.

8. The processing unit of the medical energy device according to claim 7, wherein, The thickness of the covering film is 50 μm or more.

9. A medical energy device having the treatment unit as described in claim 1.

10. A method for manufacturing a treatment section of a medical energy device, wherein the treatment section of the medical energy device, while in contact with biological tissue, transfers energy to the biological tissue to treat the biological tissue, the method for manufacturing the treatment section of the medical energy device comprising the following steps: Prepare a main body and a coating liquid containing organosilicon, wherein the main body transfers the energy to the biological tissue, and the organosilicon forms a polymer comprising at least D units and T units, wherein the molar ratio of silicon atoms forming D units to all silicon atoms is 40% or more and 99% or less, and the molar ratio of methyl groups bonded to silicon atoms to all functional groups bonded to silicon atoms is 60% or more. The coating liquid is applied to the surface of the main body; and The coating liquid is heated to harden it, thereby forming a cover film, which is mainly composed of silicone and covers the surface of the main body. The covering film has a membrane structure in which a relatively soft portion is sandwiched between a plurality of relatively hard portions, which are mainly composed of Q units and are relatively hard, and the molar ratio of D units in the soft portion is higher than the molar ratio of D units in the hard portion.

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