Ultrasonic coupling material composite membrane and ultrasonic inspection method

Abstract

The invention relates to an ultrasonic coupling material composite membrane and an ultrasonic inspection method. Provided are an ultrasonic coupling material composite film having opposite characteristics of adhesiveness and non-adhesiveness, and an ultrasonic inspection method using the composite film. The present invention relates to an ultrasonic coupling material composite membrane, which is inserted between the surface of an ultrasonic probe and the skin, and is characterized by comprising: a gel coupling material membrane comprising a gel containing water; and a silicone coupling material film that contains a crosslinkable silicone resin and a silicone oil that does not have a crosslinking point.

Description

Technical Field

[0001] This invention relates to an ultrasound coupling material composite membrane and an ultrasound examination method. The aforementioned ultrasound coupling material composite membrane comes into contact with the skin of a living organism, making the condition of internal organs and blood vessels visible, and is used to measure pulse and blood pressure. Background Technology

[0002] In recent years, with the popularization of IoT (Internet of Things), the development of wearable devices is progressing. Clocks and glasses that can connect to the internet are representative examples. In addition, the medical and sports fields also require wearable devices that can continuously monitor the body's condition, representing future growth areas.

[0003] For example, some have proposed a watch-shaped wearable device equipped with optical sensors, electrostatic capacitive sensors, ultrasonic sensors, pressure sensors, etc. (Patent Document 1).

[0004] Wearable devices capable of performing ultrasound diagnostics (examinations) are being researched. In this case, the condition of internal organs and blood vessels can be visualized, and pulse and blood pressure can be continuously measured (Patent Document 2).

[0005] In ultrasound diagnostic instruments, an ultrasound probe is placed in close contact with the skin. Ultrasound waves emitted from the probe's surface by the ultrasound transmitter bounce off within the body, and the probe detects the information within the body at the receiver. During ultrasound measurement, if the surface to be measured has unevenness, and the surface of the ultrasound probe cannot cover the unevenness, resulting in an air layer, the ultrasound waves emitted from the probe's surface are reflected by the air layer and cannot reach the body. The ultrasound transmission speed of a polysiloxane rubber ultrasound probe at room temperature is approximately 1000 m / s, while the ultrasound speed in air is 340 m / s. Due to this large speed difference, the transmission of ultrasound waves is hindered at the interface between the ultrasound probe and the air; therefore, there must be no air between the ultrasound probe and the skin. Therefore, during ultrasound diagnosis, a water-soluble gel matrix coupling material is inserted between the ultrasound probe and the skin (Patent Document 3). Patent Document 4 exemplifies many applications for water-soluble coupling materials.

[0006] For single-use ultrasound measurements, a cream of water-soluble gel-based coupling material is applied to the skin, or a film of the water-soluble gel-based coupling material is made in close contact with the skin, and an ultrasound probe is attached to it for measurement. After the measurement, if the coupling material is a cream, it can be wiped off with a cloth or paper or rinsed with water. However, if the ultrasound probe is worn for an extended period, and sweating occurs during exercise, showering, or bathing, the cream-like water-soluble gel will dissolve. If the coupling material disappears, the ultrasound signal cannot be received. Therefore, for long-term wear applications, there is a problem with using cream-gel coupling materials.

[0007] Therefore, proposals have been made for non-water-soluble coupling materials. For example, proposals have been made for paraffin-based materials (Patent Document 5) and polysiloxane-based materials (Patent Document 6).

[0008] From the perspective of low attenuation rate and high transmission speed of ultrasound, water-containing gels are superior. Therefore, in order to prevent drying, it has been proposed to use hydrophobic polyurethane as a water-containing ultrasound coupling material as a gel (Patent Document 7).

[0009] One proposed layered coupling material involves covering a hydrogel layer with a membrane to prevent drying, and further providing an adhesive layer on the outside (Patent Document 8). By placing this material between an ultrasound probe and the skin, long-term continuous diagnostics based on an adhesive ultrasound sensor can be achieved.

[0010] Before performing an ultrasound diagnosis, the diagnostic site needs to be determined. For example, when examining the movement of the carotid artery in the head, the optimal location for observation of the carotid artery is searched by sliding an ultrasound probe with attached ultrasound coupling material across the scalp, or by repeatedly attaching and detaching the ultrasound probe. In this case, the ultrasound coupling material does not require adhesiveness and is preferably highly peelable.

[0011] Therefore, as an ultrasonic coupling material, it is necessary to have the opposite properties of adhesiveness and non-adhesion, and a material with the corresponding properties is desired.

[0012] Existing technical documents

[0013] Patent documents

[0014] Patent Document 1: Japanese Patent Application Publication No. 2021-093127

[0015] Patent Document 2: International Publication No. 2020 / 049934

[0016] Patent Document 3: Japanese Patent Application Publication No. 46-000146

[0017] Patent Document 4: Japanese Patent Publication No. 2005-532871

[0018] Patent Document 5: Japanese Patent Application Publication No. 63-019135

[0019] Patent Document 6: US Patent No. 9211106

[0020] Patent Document 7: Japanese Patent Application Publication No. 2020-183929

[0021] Patent Document 8: U.S. Patent Application Publication No. 2023 / 0277159 Summary of the Invention

[0022] [The problem the invention aims to solve]

[0023] The present invention was made to solve the above-mentioned problems, and its purpose is to provide an ultrasonic coupling material composite film having opposite properties of adhesiveness and non-adhesion, and an ultrasonic inspection method using the composite film.

[0024] [Methods used to solve problems]

[0025] To address the aforementioned issues, this invention provides an ultrasonic coupling material composite membrane, which is inserted between the surface of an ultrasonic probe and the skin. The membrane is characterized by comprising: a gel coupling material membrane composed of a water-containing gel; and a polysiloxane coupling material membrane containing a cross-linked polysiloxane resin and a polysiloxane oil without cross-linking points.

[0026] If it is the ultrasonic coupling material composite film of the present invention, it can take into account the opposite characteristics of adhesiveness and non-adhesiveness.

[0027] In the above composite membrane, it is preferable that the gel coupling material membrane has adhesive properties.

[0028] If it is such a composite membrane, then an ultrasound probe with an adhesive gel coupling material membrane attached to the skin can be attached to the area to be examined for a long-term ultrasound examination.

[0029] In this invention, it is preferable that the aforementioned polysiloxane coupling material membrane is composed of a cured form of an addition-curing polysiloxane coupling material composition, wherein the aforementioned addition-curing polysiloxane coupling material composition contains (A) an alkenyl diorganopolysiloxane, (B) a polysiloxane oil without crosslinking points, (C) a SiH-based organohydrogen polysiloxane, and (D) a platinum group metal catalyst.

[0030] If such an addition-curing polysiloxane coupling material composition is used, an ultrasonic coupling material composite film with non-adhesive (low-adhesive) polysiloxane coupling material film can be obtained.

[0031] In this case, the value obtained by dividing the number of moles of SiH groups in component (C) by the number of moles of alkenes in component (A) is preferably in the range of 0.5 to 20.

[0032] In addition, the above-mentioned component (B) has a kinematic viscosity of 10 to 50,000 mm at 25°C. 2 Straight-chain or branched diorganopolysiloxanes in the range of / s that do not have cross-linking points and do not have alkenyl or SiH groups are preferred.

[0033] Furthermore, in this invention, it is preferable that the value obtained by dividing the mass of the aforementioned component (B) by the total mass of the aforementioned component (A), the aforementioned component (B), and the aforementioned component (C) is in the range of 0.20 to 0.90.

[0034] If such an addition-curing polysiloxane coupling material composition is used, the non-adhesiveness of the polysiloxane coupling material film can be appropriately adjusted.

[0035] Furthermore, the present invention is preferably made of dry silica comprising 0.1 to 10 parts by mass relative to the total 100 parts by mass of the components (A) to (C) described above.

[0036] If it is such a substance, it can effectively prevent the seepage of polysiloxane oil.

[0037] In addition, in this invention, it is preferred that the thickness of the above-mentioned polysiloxane coupling material film is in the range of 10 to 5000 μm.

[0038] In this invention, a membrane of such thickness can be used as the polysiloxane coupling material membrane.

[0039] Furthermore, in this invention, it is even more preferable to form films on both sides of the gel coupling material film, and then form an adhesive film on its outer side.

[0040] By attaching membrane sheets to both sides of the gel coupling membrane, the hydrogel can be prevented from drying out.

[0041] Furthermore, the present invention is further preferred to have a release liner film on one or both sides of the above-mentioned ultrasonic coupling material composite film.

[0042] By using a release liner, the ultrasonic coupling material composite film of the present invention can be obtained efficiently.

[0043] In addition, the present invention provides an examination method (excluding methods for performing surgery, treatment, or diagnosis on a person), which is an ultrasonic examination method using the above-mentioned ultrasonic coupling material composite membrane, characterized in that:

[0044] The ultrasonic coupling material composite membrane is inserted between the ultrasonic probe surface and the subject, with the gel coupling material membrane of the composite membrane facing the surface of the ultrasonic probe and the polysiloxane coupling material membrane of the composite membrane facing the subject.

[0045] The polysiloxane coupling material membrane is brought into contact with the object being inspected to locate the site for ultrasonic examination.

[0046] In this type of ultrasound examination method, by using an ultrasound coupling material composite film with opposite properties of adhesion and non-adhesion, the non-adhesive (low-adhesion) polysiloxane coupling material (film) can slide on the skin or repeatedly adhere and peel off while finding the optimal ultrasound examination site, while the (e.g., adhesive) gel coupling material (film) can achieve long-term adhesion to the skin. Furthermore, in an ultrasound examination method using such an ultrasound coupling material composite film, the optimal ultrasound examination site can be found by repeatedly contacting and peeling off the skin or by lateral sliding. Once the ultrasound examination site is found, the non-adhesive coupling material film can be peeled off and the gel coupling material film can be adhered to the skin.

[0047] The inspection method of the present invention can repeatedly contact and peel off the aforementioned object to be inspected, or slide on the object to be inspected to find the ultrasonic inspection site. Alternatively, the aforementioned polysiloxane coupling material film can be peeled off, and the aforementioned gel coupling material film can be contacted and fixed with the aforementioned object to be inspected for continuous ultrasonic inspection.

[0048] Thus, by using the ultrasonic coupling material composite film of the present invention, the optimal ultrasonic examination site can be found while repeatedly contacting and peeling off the skin or while sliding laterally. Once the ultrasonic examination site is determined, the non-adhesive polysiloxane coupling material film can be peeled off, and the gel coupling material film (e.g., adhesive) can be attached to the skin. This enables highly efficient ultrasonic examinations.

[0049] Furthermore, the present invention provides a method for forming a laminated structure, characterized in that an addition-curing polysiloxane coupling material composition is coated onto a release liner membrane, and then heated and cured to form a polysiloxane coupling material membrane. This polysiloxane coupling material membrane is then attached to a gel coupling material membrane composed of an aqueous gel, and an ultrasonic probe is attached to the side of the gel coupling material membrane opposite to the side in contact with the polysiloxane coupling material membrane to form a laminated structure.

[0050] The addition-curing polysiloxane coupling material composition contains: (A) an alkenyl diorganopolysiloxane, (B) a polysiloxane oil without crosslinking points, (C) a SiH-based organohydrogen polysiloxane, and (D) a platinum group metal catalyst.

[0051] Alternatively, the polysiloxane coupling material film can be peeled off from the gel coupling material film and then attached to the ultrasonic probe to form a laminated structure.

[0052] In this way, by appropriately forming a layered structure, ultrasonic inspection can be performed efficiently.

[0053] [The effects of the invention]

[0054] As described above, the ultrasonic coupling material composite film of the present invention can combine the opposite characteristics of adhesiveness and non-adhesiveness. For example, if a non-adhesive polysiloxane coupling material (film) is brought into contact with the subject side, such as skin, the optimal ultrasonic examination site can be found while sliding on the skin or repeatedly adhering and peeling on the skin. When the (e.g., adhesive) gel coupling material (film) is in contact with the subject side, it can adhere to the skin for a long time, enabling stable ultrasonic examination. Furthermore, if an ultrasonic examination method using such an ultrasonic coupling material composite film is employed, the optimal ultrasonic examination site can be found while repeatedly contacting and peeling with the skin or while laterally sliding. Once the ultrasonic examination site is determined, the non-adhesive coupling material film can be peeled off, and the gel coupling material film (e.g., adhesive) can be adhered to the skin. Attached Figure Description

[0055] Figure 1 This is a schematic cross-sectional view illustrating an example of a peelable polysiloxane coupling material membrane according to the present invention.

[0056] Figure 2 This is a schematic cross-sectional view illustrating an example of a composite membrane of the present invention, consisting of a peelable polysiloxane coupling material membrane and a coupling material membrane containing an aqueous gel (hydrogel coupling material membrane).

[0057] Figure 3 This is a schematic cross-sectional view showing an example of attaching the ultrasonic coupling material composite film of the present invention to an ultrasonic probe.

[0058] Figure 4 This is a schematic cross-sectional view showing an example of attaching the ultrasonic probe of the present invention, which is equipped with an ultrasonic coupling material composite film, to the skin.

[0059] Figure 5This is a schematic cross-sectional view of an example in which, after determining the diagnostic site, a peelable polysiloxane coupling material membrane is peeled off, and an ultrasound probe with an adhesive water-containing coupling material membrane attached is applied to the skin.

[0060] Figure 6 It means Figure 4 A schematic cross-sectional view of an example of a hydrogel coupling material membrane containing water, wherein membrane sheets are attached to both sides of the hydrogel coupling material membrane, and an adhesive membrane is attached to its outer side.

[0061] Figure 7 It means from Figure 6 A schematic cross-sectional view of an example of peeling off the polysiloxane coupling material membrane from the coupling material composite membrane and attaching the exposed hydrogel coupling material membrane to the skin.

[0062] Figure 8 A cross-sectional view of a peelable polysiloxane coupling material membrane that has been peeled off.

[0063] Figure 9 This is a cross-sectional view of a peelable polysiloxane coupling material film that has been peeled off using a rod with a circular cross-section.

[0064] Figure 10 It is a cross-sectional diagram showing the transmission of ultrasound waves emitted from an ultrasound probe to the skin via a coupling material.

[0065] Figure 11 It is a cross-sectional view showing that the ultrasound waves emitted from the ultrasound probe are transmitted to the skin without the aid of coupling material.

[0066] Figure 12 This is a photograph of an ultrasound diagnostic instrument viewed from the side of the ultrasound probe.

[0067] Figure 13 This is an ultrasound image taken during a head ultrasound examination of the carotid artery.

[0068] Figure 14 These are photographs of ultrasound images of the carotid artery portion when using the ultrasound coupling material composite membrane of the present invention.

[0069] Figure 15 These are photographs of ultrasound images of the carotid artery portion when the comparative example of the laminated ultrasound coupling material was used. Detailed Implementation

[0070] As mentioned above, there is a need for both non-adhesive ultrasound coupling materials that can slide on the skin or repeatedly adhere and peel off to find the optimal ultrasound examination site, and adhesive ultrasound coupling materials that can adhere to the skin for a long time.

[0071] Therefore, the inventors conducted repeated and in-depth research on the above-mentioned issues, and as a result conceived of an ultrasound coupling material composite membrane with a layered structure, in which a non-adhesive polysiloxane coupling material membrane is disposed on the skin side of a gel coupling material membrane (which may be adhesive). It was discovered that if such a composite membrane is used, while repeatedly contacting and peeling it off the skin or sliding it laterally to find the optimal ultrasound examination site, once the ultrasound examination site is found, the non-adhesive polysiloxane coupling material membrane can be peeled off and the gel coupling material membrane can be attached to the skin, thus completing the present invention. Furthermore, the following description, as one method of ultrasound examination, sometimes refers to ultrasound diagnosis.

[0072] As a non-adhesive polysiloxane coupling material membrane, polysiloxane-based coupling material membranes can be considered. This is because polysiloxane has excellent peelability, and can be easily peeled off when stacked with an adhesive gel coupling film.

[0073] That is, the present invention provides an ultrasonic coupling material composite film, which is an ultrasonic coupling material composite film inserted between the surface of an ultrasonic probe and the skin, characterized in that it comprises: a gel coupling material film composed of a water-containing gel; and a polysiloxane coupling material film containing a cross-linked polysiloxane resin and a polysiloxane oil without cross-linking points.

[0074] Patent document 6 disclosed a coupling material using polysiloxane gel. Polysiloxane gel is an extremely soft polysiloxane rubber with an extremely low crosslinking density. However, softness alone is insufficient to fill the micro-unit micro-unevenness of soft skin.

[0075] To make polysiloxane gels softer, methods such as adding non-crosslinked polysiloxane oils or hydrocarbon-based mineral oils can be described in Japanese Patent Application Publication No. 2015-028178. The addition of non-crosslinked polysiloxane oils improves the embedding characteristics into the skin's contours, thus increasing the sensitivity of ultrasound measurements when used as an ultrasound coupling material. However, with the addition of large amounts of non-crosslinked polysiloxane oils, exudation occurs, leaving polysiloxane oil residue on the skin when the coupling membrane is peeled off after ultrasound measurement. Removing this residue requires wiping the skin with a towel or cotton ball soaked in mineral oil, which is laborious and inefficient.

[0076] Adding dry silica is effective in preventing the seepage of polysiloxane. Adding MQ resin also helps prevent polysiloxane seepage, but it is undesirable for this application due to its adhesive properties. For a non-adhesive prevention of polysiloxane seepage, adding dry silica is preferable.

[0077] Water exhibits a similar, relatively low, ultrasonic attenuation rate to the human body, and its transmission speed is also similar. Aqueous gels possess excellent ultrasonic transmission properties. On the other hand, while polysiloxane has a lower ultrasonic attenuation rate than polyurethane and acrylic, its ultrasonic attenuation rate is higher than that of water. When the ultrasonic attenuation rate is high, the ultrasonic image of the coupling material using it becomes darker, and the contrast decreases. In precise ultrasonic measurements, hydrogel coupling materials have advantages. However, to locate the ultrasonic measurement site, the high ultrasonic transmission characteristics of hydrogels are not necessary; instead, the advantages of highly peelable polysiloxane coupling materials are more advantageous.

[0078] As an ultrasonic coupling material for hydrogels, it is a composition containing water in a cross-linked water-soluble polymer, and the compositions described in Patent Documents 3, 4, and 7 can be used.

[0079] The present invention will now be described in detail, but it is not limited thereto.

[0080] <Composition of Polysiloxane Coupling Material>

[0081] The polysiloxane coupling material (polysiloxane ultrasonic coupling material) used in the ultrasonic testing method of the present invention comprises cross-linked polysiloxane rubber and non-cross-linked polysiloxane oil. The components are described in more detail below.

[0082] The polysiloxane coupling material composition used in the ultrasonic inspection method of the present invention is preferably an addition-hardening polysiloxane coupling material composition containing (A) an alkenyl diorganopolysiloxane, (B) a polysiloxane oil without crosslinking points, (C) an organohydrogen polysiloxane with SiH groups, and (D) a platinum group metal catalyst.

[0083] [(A) ingredient]

[0084] The component (A) incorporated in the polysiloxane coupling material composition of the present invention is an alkenyl diorganopolysiloxane. For example, an alkenyl diorganopolysiloxane equivalent to component (A1) described in Japanese Patent Application Publication No. 2015-193803, and having a viscosity of 100,000 mPa·s or higher at 25°C, can be used.

[0085] Examples of alkenyl groups include vinyl, allyl, hexenyl, octenyl, acryloylpropyl, acryloylmethyl, methacryloylpropyl, and ethyleneoxypropyl, with vinyl being particularly preferred.

[0086] The group other than the alkenyl group is a monovalent hydrocarbon group having 1 to 10 carbon atoms, either substituted or unsubstituted. Specifically, examples include: alkyl groups such as methyl, ethyl, propyl, and butyl; cycloalkyl groups such as cyclohexyl; aryl groups such as phenyl and tolyl; and groups in which some or all of the hydrogen atoms bonded to the carbon atoms of these groups are substituted with other groups such as halogen, amino, hydroxyl, or cyano, for example, 3-aminopropyl, 3,3,3-trifluoropropyl, 3-hydroxypropyl, and 3-cyanopropyl. Methyl and phenyl are particularly preferred.

[0087] Furthermore, as component (A), it may contain a diorganopolysiloxane (A2) corresponding to component (A2) disclosed in Japanese Patent Application Publication No. 2015-193803, having a viscosity of 100,000 mPa·s or more at 25°C, and not having an alkenyl group. The polysiloxanes (A1) and (A2) described above may be linear or branched.

[0088] Examples of polysiloxane resins include addition-curing and free-radical crosslinking types. In the addition-curing type, alkenyl and SiH groups crosslink via an addition reaction, but in the free-radical curing type, crosslinking occurs not only with alkenyl groups but also even when alkenyl groups are absent. In this case, crosslinking also occurs with the polysiloxane oil (B) component, which does not have crosslinking groups. Therefore, the fluidity of the polysiloxane oil decreases, its implantation performance in the skin decreases, and its sensitivity as an ultrasound coupling material may decrease. Therefore, the addition-curing type is preferred over the free-radical crosslinking type.

[0089] In addition, as component (A), a modified siloxane may be added having a group selected from amino, oxetyl, oxetyl, polyether, hydroxyl, carboxyl, mercapto, methacrylate, acrylate, phenol, silanol, carboxylic anhydride, aryl, aralkyl, amide, ester, and lactone groups. The modified siloxane may be a siloxane with any of its single-terminal, double-terminal, or side chain modified.

[0090] Reducing the amount of cyclic siloxanes such as octamethylcyclotetrasiloxane and decamethylcyclopentasiloxane in ingredient (A) is effective in reducing skin irritation. The method for reducing this amount is described in Japanese Patent Application Publication No. 2015-193803.

[0091] Components (A1) and (A2) can be in an oily or rubbery form. In the case of a rubbery form, when the viscosity is high (exceeding 500,000 mPa·s), the viscosity when dissolved in toluene at a concentration of 30% by mass (30% dissolution viscosity) is preferably 100,000 mPa·s or less. Furthermore, the 30% dissolution viscosity is preferably 1,000 to 60,000 mPa·s. If the 30% dissolution viscosity is 100,000 mPa·s or less, the composition will not become so viscous that stirring during manufacturing becomes difficult. Also, in this invention, the above-mentioned viscosity (absolute viscosity) is a value measured at 25°C using a rotational viscometer.

[0092] [(B) Component]

[0093] (B) The component is a non-crosslinking polysiloxane oil with a dynamic viscosity of 10–50,000 mm at 25°C. 2 A linear or branched diorganopolysiloxane with no crosslinking points and without alkenyl and SiH groups is preferred, with a kinematic viscosity of 50–50,000 mmHg at 25°C. 2 The range of / s is better. "Cross-linking point" refers to the point where alkenyl groups, SiH groups, etc., cross-link between molecules.

[0094] For example, KF-96 manufactured by Shin-Etsu Chemical Industry Co., Ltd. can be used as a non-crosslinked polysiloxane oil. Its kinematic viscosity at 25°C corresponds to the number before CS in the product name; for example, "KF-96 1,000CS" has a kinematic viscosity of 1,000 mmHg. 2 / s, the kinematic viscosity of "KF-96 100CS" is 100mm. 2 / s. Also, the kinematic viscosity is a value measured at 25°C using an Orthocriteus viscometer.

[0095] In its monomeric form, component (B) is a fluid oil at room temperature. By adding component (B), the ultrasonic transmissibility can be improved by filling in the micro-bumps and depressions of the skin when the ultrasonic coupling membrane is applied to the skin.

[0096] The value obtained by dividing the mass of component (B) by the total mass of component (A), component (B) and component (C) is preferably in the range of 0.20 to 0.90, even more preferably in the range of 0.30 to 0.90, and even more preferably in the range of 0.30 to 0.88.

[0097] [(C) Component]

[0098] Component (C) corresponds to component (C) described in Japanese Patent Application Publication No. 2015-193803, and is an organohydrogen polysiloxane having SiH groups. The viscosity of component (C) at 25°C is preferably 1 mPa·s to 1,000 mPa·s, and more preferably 2 mPa·s to 500 mPa·s. Furthermore, component (C) can be a combination of two or more components. It can be a linear, branched, or cyclic structure. The number of SiH groups is preferably two or more per molecule of the organohydrogen polysiloxane.

[0099] An alkenyl diorganosiloxane (A1) and an organohydrogen polysiloxane (C) having multiple SiH groups can be crosslinked by an addition reaction using a platinum catalyst. The ratio obtained by dividing the molar number of SiH groups by the molar number of alkenyl groups is preferably in the range of 0.5 to 20, more preferably in the range of 1 to 15.

[0100] [(D) component]

[0101] Platinum group metal catalysts as component (D) include, for example, platinum group metal catalysts such as chloroplatinic acid, alcoholic solutions of chloroplatinic acid, reaction products of chloroplatinic acid with alcohols, reaction products of chloroplatinic acid with olefin compounds, reaction products of chloroplatinic acid with vinyl-containing siloxanes, platinum-olefin complexes, platinum-vinyl-containing siloxane complexes, etc.; ruthenium group metal catalysts such as ruthenium complexes, etc.; and ruthenium group metal catalysts such as ruthenium complexes, etc. Alternatively, substances obtained by dissolving and dispersing these catalysts in alcohol-based, hydrocarbon-based, or siloxane-based solvents can also be used.

[0102] Furthermore, relative to 100 parts by mass of the resin solution formed by combining (A), (B), (C) and the organic solvent, the amount of platinum group metal catalyst added is preferably set to 5 to 2,000 ppm (metal mass conversion), and particularly preferably set to the range of 10 to 500 ppm.

[0103] Alternatively, when using addition-curing polysiloxane resins, an addition reaction control agent may be added. This addition reaction control agent is added as a quencher to prevent the platinum group metal catalyst from reacting in the low-temperature environment of the solution and before heat curing after coating formation. Specifically, examples include 3-methyl-1-butyn-3-ol, 3-methyl-1-pentyn-3-ol, 3,5-dimethyl-1-hexyn-3-ol, 1-ethynylcyclohexanol, 3-methyl-3-trimethylsilyloxy-1-butyn, 3-methyl-3-trimethylsilyloxy-1-pentyn, 3,5-dimethyl-3-trimethylsilyloxy-1-hexyn, 1-ethynyl-1-trimethylsilyloxycyclohexane, bis(2,2-dimethyl-3-butynoxy)dimethylsilane, 1,3,5,7-tetramethyl-1,3,5,7-tetravinylcyclotetrasiloxane, and 1,1,3,3-tetramethyl-1,3-divinyldisiloxane.

[0104] The amount of addition reaction control agent added is preferably 0 to 10 parts by weight relative to 100 parts by weight of resin solution, and particularly preferably 0.05 to 3 parts by weight.

[0105] [Silica particles]

[0106] The polysiloxane coupling material composition of the present invention may incorporate silica microparticles, wherein dry silica microparticles may be added. By adding dry silica, the strength of the ultrasonic coupling material film is improved, the film is less prone to breakage when peeled from the release liner, and it adheres easily to the skin and ultrasonic probe. It also prevents the seepage of polysiloxane oil of component (B) and prevents a decrease in adhesion when the polysiloxane oil adheres to the skin after peeling and when the hydrogel coupling material film is subsequently applied. The specific surface area of ​​the dry silica is 50 to 500 m². 2 / g range, 100~400m 2 / g is preferred. Specific surface area can be determined by the BET method. Silica prepared by replacing the silanols on the silica surface with trimethylsilyl, dimethylsilyl, or dimethylpolysiloxane has high dispersibility and better properties.

[0107] Commercially available products can be used for dry silica, such as AEROSIL RX200 (manufactured by Nippon Aerosil).

[0108] Regarding the amount of silica added, it is preferable to add 0.1 to 10 parts by mass of dry silica relative to the total 100 parts by mass of components (A) to (C).

[0109] [Organic solvents]

[0110] Furthermore, organic solvents can be added to the composition of the polysiloxane coupling material of the present invention. Specifically, organic solvents include, for example, toluene, xylene, cumene, 1,2,3-trimethylbenzene, 1,2,4-trimethylbenzene, 1,3,5-trimethylbenzene, styrene, α-methylstyrene, butylbenzene, sec-butylbenzene, isobutylbenzene, isopropyltoluene (cymene), diethylbenzene, 2-ethyl-p-xylene, 2-propyltoluene, 3-propyltoluene, 4-propyltoluene, 1,2,3,5-tetramethyltoluene, 1,2,4,5-tetramethyltoluene, tetrahydronaphthalene, 4-phenyl-1-butene, tert-pentylbenzene, pentylbenzene, 2-tert-butyltoluene, 3-tert-butyltoluene, 4-tert-butyltoluene, 5-isopropyl-m-xylene, 3-methylethylbenzene, tert-butyl-3-ethylbenzene, 4-tert-butyl-o-xylene, 5 - Aromatic hydrocarbon solvents such as tert-butyl-m-xylene, tert-butyl-p-xylene, 1,2-diisopropylbenzene, 1,3-diisopropylbenzene, 1,4-diisopropylbenzene, dipropylbenzene, pentamethylbenzene, hexamethylbenzene, hexylbenzene, 1,3,5-triethylbenzene, n-heptane, isoheptane, 3-methylhexane, 2,3-dimethylpentane, 3-ethylpentane, 1,6-heptadiene, 5-methyl-1-hexyne, norcamphene, norcamphene, dicyclopentadiene, 1-methyl-1,4-cyclohexadiene, 1-heptyne, 2-heptyne, cycloheptane, cycloheptene, 1,3-dimethylcyclopentane, ethylcyclopentane, methylcyclohexane, 1-methyl-1-cyclohexene, 3-methyl-1-cyclohexene, methylenecyclohexane, 4-methyl-1-cyclohexane Alkene, 2-methyl-1-hexene, 2-methyl-2-hexene, 1-heptene, 2-heptene, 3-heptene, n-octane, 2,2-dimethylhexane, 2,3-dimethylhexane, 2,4-dimethylhexane, 2,5-dimethylhexane, 3,3-dimethylhexane, 3,4-dimethylhexane, 3-ethyl-2-methylpentane, 3-ethyl-3-methylpentane, 2-methylheptane, 3-methylheptane, 4-methylheptane, 2,2,3-trimethylpentane, 2,2,4-trimethylpentane, cyclooctane, cyclooctene, 1,2-dimethylcyclohexane, 1,3-dimethylcyclohexane, 1,4-dimethylcyclohexane, ethylcyclohexane, vinylcyclohexane, isopropylcyclopentane, 2,2-dimethyl-3-hexene 2,4-Dimethyl-1-hexene, 2,5-Dimethyl-1-hexene, 2,5-Dimethyl-2-hexene, 3,3-Dimethyl-1-hexene, 3,4-Dimethyl-1-hexene, 4,4-Dimethyl-1-hexene, 2-Ethyl-1-hexene, 2-Methyl-1-heptene, 1-Octenene, 2-Octenene, 3-Octenene, 4-Octenene, 1,7-Ocadiene, 1-Octyne, 2-Octyne, 3-Octyne, 4-Octyne, n-Nonane, 2,3-Dimethylheptane, 2,4-Dimethylheptane, 2,5-Dimethylheptane, 3,3-Dimethylheptane, 3,4-Dimethylheptane, 3,5-Dimethylheptane, 4-Ethylheptane, 2-Methyloctane, 3-Methyloctane, 4-Methyloctane, 2,2,4,4-Tetramethylpentane, 2,2,4-Trimethylhexane, 2,2,5-Trimethylhexane, 2,2-Dimethyl-3-heptene, 2,3-Dimethyl-3-heptene, 2,4-Dimethyl-1-heptene, 2,6-Dimethyl-1-heptene, 2,6-Dimethyl-3-heptene, 3,5-Dimethyl-3-heptene, 2,4,4-Trimethyl-1-hexene, 3,5,5-Trimethyl-1-hexene, 1-Ethyl-2-methylcyclohexane, 1-Ethyl-3-methylcyclohexane, 1-Ethyl-4-methylcyclohexane, Propyl Cyclohexane, isopropylcyclohexane, 1,1,3-trimethylcyclohexane, 1,1,4-trimethylcyclohexane, 1,2,3-trimethylcyclohexane, 1,2,4-trimethylcyclohexane, 1,3,5-trimethylcyclohexane, allylcyclohexane, hydrindane, 1,8-nonadiene, 1-nonyne, 2-nonyne, 3-nonyne, 4-nonyne, 1-nonene, 2-nonene, 3-nonene, 4-nonene, n-decane, 3,3-dimethyloctane, 3,5-dimethyloctane, 4,4-dimethyloctane, 3- Ethyl-3-methylheptane, 2-methylnonane, 3-methylnonane, 4-methylnonane, tert-butylcyclohexane, butylcyclohexane, isobutylcyclohexane, 4-isopropyl-1-methylcyclohexane, pentylcyclopentane, 1,1,3,5-tetramethylcyclohexane, cyclododecane, 1-decene, 2-decene, 3-decene, 4-decene, 5-decene, 1,9-decadiene, decahydronaphthalene, 1-decyne, 2-decyne, 3-decyne, 4-decyne, 5-decyne, 1,5,9-decytriene, 2,6-dimethyl-2,4,6-octtriene, limonene Alkenes, myrcene, 1,2,3,4,5-pentamethylcyclopentadiene, α-phellandrene, pinene, terpinene, tetrahydrodicyclopentadiene, 5,6-dihydrodicyclopentadiene, dicyclopentadiene, 1,4-decadiyne, 1,5-decadiyne, 1,9-decadiyne, 2,8-decadiyne, 4,6-decadiyne, n-undecane, pentylcyclohexane, 1-undecane, 1,10-undecadiene, 1-undecaneyne, 3-undecaneyne, 5-undecaneyne, tricyclic [6.2.1.0, 2,7 [Aliphatic hydrocarbon solvents such as undecane-4-ene, n-dodecane, n-tetrazane, n-pentadecane, n-hexadecane, 2-methylundecane, 3-methylundecane, 4-methylundecane, 5-methylundecane, 2,2,4,6,6-pentamethylheptane, 1,3-dimethyladamantane, 1-ethyladamantane, 1,5,9-cyclododecanetriene, 1,2,4-trivinylcyclohexane, and isoalkanes.]

[0111] Furthermore, the amount of organic solvent added is preferably in the range of 10 to 50,000 parts by mass relative to a total of 100 parts by mass of components (A) and (B).

[0112] (A) It is desirable that the composition does not contain MQ resin, which exhibits adhesive properties. MQ resin can exist stably in non-polar solvents, and therefore contains solvent. In the absence of MQ resin in a solvent-containing state, the composition of the polysiloxane coupling material used in the ultrasonic testing of the present invention may not necessarily contain organic solvents.

[0113] [Other Additives]

[0114] In the polysiloxane coupling material composition of the present invention, in addition to the aforementioned dry silica, inorganic particles such as wet silica, alumina particles, titanium dioxide particles, and zirconium oxide particles, as well as pigments, can also be mixed. The strength is improved by adding wet silica particles, alumina particles, titanium dioxide particles, and zirconium oxide particles. Pigments are added when coloring is desired. Both dry and wet alumina particles, titanium dioxide particles, and zirconium oxide particles are ideal, and their dispersibility is superior when surface-treated with hydrophobic silicon-based materials. The shapes of the wet silica, alumina particles, titanium dioxide particles, and zirconium oxide particles can be spherical, elliptical, irregular, hollow, or porous.

[0115] <Ultrasonic Coupling Material Composite Film>

[0116] The ultrasonic coupling material composite membrane of the present invention comprises a gel coupling material membrane composed of a water-containing gel, and a polysiloxane coupling material membrane containing a cross-linked polysiloxane resin and a polysiloxane oil without cross-linking points, and is inserted between the surface of the ultrasonic probe and the skin.

[0117] The composite membrane of the present invention may simultaneously comprise an adhesive gel coupling material membrane and a non-adhesive polysiloxane coupling material membrane, thereby achieving both opposite adhesive properties.

[0118] The ultrasonic coupling material composite film of the present invention will now be described in detail with reference to the accompanying drawings, but the present invention is not limited thereto.

[0119] <Polysiloxane coupling material membrane>

[0120] In this invention, the preferred polysiloxane coupling material membrane is one containing a cross-linked polysiloxane resin and a non-cross-linked polysiloxane oil. This polysiloxane coupling material membrane is non-adhesive and, by being disposed on an adhesive hydrogel coupling membrane in a manner that allows insertion between the hydrogel coupling membrane and the skin, allows for the transmission of ultrasound between the skin and the ultrasound probe via the polysiloxane coupling material membrane without direct contact between the hydrogel coupling membrane and the skin.

[0121] Polysiloxane coupling material membranes can be formed on release liner membranes using polysiloxane coupling material compositions.

[0122] Figure 1This is a schematic cross-sectional view showing an example of the polysiloxane coupling material membrane of the present invention. Figure 1 The polysiloxane coupling material 1 represents the morphology formed on the release liner 11.

[0123] As the substrate for the release liner, options include paper, plastic films made of plastic, glass, metal, and fabric. Examples of paper include high-quality paper, coated paper, art paper, cellophane, polyethylene laminated paper, kraft paper, Japanese paper, and synthetic paper. Examples of plastic films include polyethylene film, polypropylene film, polyester film, polyimide film, polyamide film, polyvinylidene chloride film, polyvinylidene chloride film, polyvinyl alcohol film, polycarbonate film, polytetrafluoroethylene film, polystyrene film, ethylene-vinyl acetate copolymer film, ethylene-vinyl alcohol copolymer film, triacetyl cellulose film, polyetheretherketone film, and polyphenylene sulfide film. Regarding glass, there are no particular restrictions on thickness or type; it can be chemically strengthened glass. Glass fiber can also be used, either alone or in combination with other resins. Fabrics include natural fiber cloth, synthetic fiber cloth, and artificial leather. Metals include aluminum foil, copper foil, gold foil, silver foil, and nickel foil. Among these, paper and plastic film are preferred, especially polyester film.

[0124] By coating the substrate of the release liner with a fluorine-based release agent as described in Japanese Patent Application Publication Nos. 2020-100763 and 2020-100764, the release force can be reduced.

[0125] <Hydrogel Coupling Material Membrane>

[0126] The hydrogel coupling material membrane that can be used in this invention is any gel coupling material membrane composed of an aqueous gel, without particular limitation, but it is preferably adhesive. From the viewpoint of low ultrasonic attenuation rate and fast transmission speed, aqueous gels are superior.

[0127] As a hydrogel coupling material (membrane), a water-soluble gel that has undergone water-resistant treatment or other measures as needed can also be used; however, it may be lost due to sweat, etc., so a non-water-soluble gel coupling material is preferred. There are no particular limitations on non-water-soluble gel coupling materials; for example, the aqueous ultrasonic coupling material using hydrophobic polyurethane as a gel described in Patent Document 7, and the laminated coupling material described in Patent Document 8, in which a hydrogel layer is covered by a membrane, and an adhesive layer is further provided on the outside. By placing it between the ultrasonic probe and the skin, long-term continuous diagnosis based on an adhesive ultrasonic sensor can be achieved. Alternatively, an adhesive hydrogel coupling material membrane can be made by attaching an acrylic adhesive or similar adhesive to both sides of the hydrogel coupling material membrane.

[0128] Commercially available products can be used as hydrogel coupling material membranes. For example, the Yashima Echo Gel Pad EP-S-03 (manufactured by Yashima PROSEED) can be used, which contains hydrogel polyurethane gel.

[0129] <Manufacturing Method of Ultrasonic Coupling Material Composite Film>

[0130] The ultrasonic coupling material composite film of the present invention can be manufactured as follows, but any method that can obtain the composite film of the present invention is acceptable and is not limited thereto.

[0131] <Manufacturing Method of Polysiloxane Coupling Material Film>

[0132] like Figure 1 As shown, in order to form a polysiloxane coupling material film 1 on the release liner 11, a polysiloxane coupling material composition is coated onto the release liner 11. The method for coating the ultrasonic coupling material composition onto the substrate of the release liner is not particularly limited, and methods such as dip coating, spray coating, spin coating, rod coating, comma coating, slot coating, roller coating, flow coating, doctor blade coating, screen printing, flexographic printing, gravure printing, and inkjet printing are preferred. The above-described composition is preferred as the polysiloxane coupling material composition.

[0133] There are no particular limitations on the curing method of the polysiloxane coupling material composition. For example, it is preferred to cure the coated film by either heat or light or both.

[0134] Furthermore, there is no particular limitation on the heating temperature; for example, it is preferably around 50–250°C. Heating methods include electric heating methods such as hot air and heating plates, as well as heating methods such as infrared radiation and microwave irradiation.

[0135] Furthermore, when combining heating with light irradiation, infrared radiation, and microwaves, heating and light irradiation, infrared radiation, and microwaves can be performed simultaneously, or heating can be performed after light irradiation, infrared radiation, and microwaves, or light irradiation, infrared radiation, and microwaves can be performed after heating. Additionally, before heating after coating, air drying can be performed to evaporate the solvent.

[0136] The thickness of the heat-cured polysiloxane coupling material membrane is preferably in the range of 10–5000 μm, more preferably in the range of 10–1000 μm, and even more preferably in the range of 20–800 μm.

[0137] Alternatively, instead of coating the polysiloxane coupling material composition onto the release liner, it can be coated onto the hydrogel ultrasonic coupling material membrane (hydrogel coupling material membrane).

[0138] Additionally, a structure can be formed in which the polysiloxane coupling material membrane is held between the top and bottom by release liner. This facilitates the transport of flexible polysiloxane coupling material membranes.

[0139] like Figure 2 As shown, the polysiloxane coupling material membrane 1 is directly attached to (e.g., an adhesive) hydrogel coupling material membrane 2. With both sides of the polysiloxane coupling material membrane held by release liner, the release liner on one side is peeled off, and the polysiloxane coupling material membrane 1 on the peeled side is attached to the hydrogel coupling material membrane 2.

[0140] like Figure 3 As shown, a composite membrane of polysiloxane coupling material membrane 1 and hydrogel coupling material 2 can also be attached to the ultrasonic probe 3.

[0141] like Figure 4 As shown, the ultrasonic probe 3, which has a composite membrane with polysiloxane coupling material membrane 1 and hydrogel coupling material 2, is repeatedly attached and peeled off on the skin 4, or it is slid laterally while searching for the best diagnostic site.

[0142] If a diagnostic site is found, peel off the polysiloxane coupling material 1, and as follows: Figure 5 As shown, an ultrasound probe with a hydrogel coupling material membrane is attached to the skin for long-term ultrasound diagnosis.

[0143] Figure 6 As shown in Patent Document 8, a composite membrane is constructed using a hydrogel coupling material membrane 2, with membrane sheets 5 and adhesive membranes 6 attached to both sides. Since the membrane sheets are intended to prevent the hydrogel from drying out, they are not necessarily needed for adhesion to the skin.

[0144] Figure 7 It is Figure 6 The polysiloxane coupling material membrane 1 of the composite membrane (composite ultrasonic coupling material) is peeled off and attached to the skin 4.

[0145] Figure 8 It is the state of the polysiloxane coupling material membrane 1 that has been peeled off.

[0146] Figure 9 It is a state in which the polysiloxane coupling material membrane 1 is peeled off while being rounded with a rod.

[0147] This is used to describe how ultrasound waves emitted from an ultrasound probe are transmitted into the skin via a coupling material in ultrasound diagnostics. Figure 10 and Figure 11 This will be explained further. In addition, the frequency of ultrasound is generally above 3MHz, the frequency used in ultrasound diagnostics.

[0148] Figure 10 A schematic cross-sectional view is shown showing the coupling material 12 sandwiched between the skin 4 and the ultrasound probe 3. The coupling material 12 is embedded in the unevenness of the skin 4, so that the ultrasound waves 7 emitted from the ultrasound probe 3 are transmitted into the skin.

[0149] on the other hand, Figure 11 This is also a schematic cross-sectional view of the state in which the coupling material 12 is sandwiched between the skin 4 and the ultrasound probe 3. However, in this case, since the coupling material 12 does not fill the unevenness of the skin 4, the ultrasound 7 is not transmitted into the skin.

[0150] As mentioned above, because the ultrasonic wave propagation speed of polysiloxane rubber relative to air is high, the transmission of ultrasonic waves is hindered at the interface between the ultrasonic probe and the air. Therefore, when an air layer exists between the surface to be measured and the surface of the ultrasonic probe during ultrasonic measurement, the ultrasonic waves emitted by the ultrasonic probe are reflected by the air layer and cannot reach the body. Figure 11 Therefore, during ultrasound diagnosis, a water-soluble gel matrix coupling material is inserted between the surface of the ultrasound probe and the skin to ensure that there is no air between the ultrasound probe and the skin. Figure 10 ).

[0151] In this invention, by using an ultrasonic coupling material composite membrane having a laminated structure in which a non-adhesive polysiloxane coupling material membrane is disposed on the skin side of a gel coupling material membrane (which may be adhesive), (1) the non-adhesive polysiloxane coupling material membrane 1 is clamped between the skin 4 and the gel coupling material membrane 2 while allowing air between the ultrasonic probe 3 and the skin 4, i.e., while repeatedly contacting and detaching from the skin or while sliding laterally to find the optimal ultrasonic examination site. Figure 4 (2) When it is necessary to ensure that there is no air between the ultrasound probe and the skin, that is, after the ultrasound examination site is determined, the non-adhesive polysiloxane coupling material membrane 1 is peeled off, and the gel coupling material membrane 2 can be directly attached to the skin 4. Figure 5 Therefore, this invention simultaneously achieves rapid identification of the ultrasound examination site and obtains appropriate examination results (clear ultrasound images).

[0152] In addition, the polysiloxane coupling material film containing cross-linked polysiloxane resin and non-cross-linked polysiloxane oil is hydrophobic and has the function of preventing the drying of water-containing gel coupling materials. The hydrophobic polysiloxane oil can prevent mixing with water.

[0153] Figure 12 This is a photograph taken from the side of the ultrasonic detector 3 of the handheld ultrasonic diagnostic instrument 10.

[0154] Figure 13 This is a photograph taken when a composite film of coupling material is attached to the probe of a handheld ultrasound diagnostic instrument to measure the ultrasound image of the carotid artery.

[0155] Figure 14 , 15 It is a measured ultrasound image, in Figure 14 A circular cross-section of the carotid artery was observed, therefore the condition was deemed good. Figure 15 No image was obtained, therefore it was judged as defective.

[0156] <Methods for forming layered structures>

[0157] In this invention, an addition-curing polysiloxane composition containing (A) an alkenyl diorganopolysiloxane, (B) a polysiloxane oil without crosslinking points, (C) a SiH-based organohydrogen polysiloxane, and (D) a platinum group metal catalyst is coated onto a release liner and heat-cured to form a polysiloxane coupling material film. Then, the polysiloxane coupling material film is attached to a gel coupling material film composed of an aqueous gel, and an ultrasonic probe is attached to the side of the gel coupling material film opposite to the side in contact with the polysiloxane coupling material film to form a laminated structure.

[0158] Alternatively, the polysiloxane coupling material film can be peeled off from the gel coupling material film, thereby attaching the gel coupling material film to the ultrasonic probe to form a laminated structure.

[0159] In this way, by appropriately forming a layered structure, ultrasonic inspection can be performed efficiently.

[0160] Example

[0161] The present invention will now be specifically described using examples and comparative examples, but the present invention is not limited thereto.

[0162] [Examples 1-6, Comparative Examples 1 and 2]

[0163] (A ingredient)

[0164] A polydimethylsiloxane containing vinyl groups with a viscosity of 27,000 mPa·s in a 49% toluene solution, an alkenyl content of 0.02 mol / 100g, and a molecular chain end capped with SiMe2Vi groups, is designated as siloxane compound 1.

[0165] (Component B)

[0166] As a non-crosslinked polysiloxane oil, KF-96 manufactured by Shin-Etsu Chemical Industry Co., Ltd., as shown in Table 1, was used. Its kinematic viscosity at 25°C corresponds to the number before CS in the table; for example, "KF-96 1,000CS" has a kinematic viscosity of 1,000 mm³. 2 / s, the kinematic viscosity of "KF-96 100CS" is 100mm. 2 / s. Also, the kinematic viscosity is a value measured at 25°C using an Orthocriteus viscometer.

[0167] (Component C)

[0168] As a methylhydropolysiloxane oil, Shin-Etsu Chemical Industry's KF-99 is used.

[0169] (additive)

[0170] Dry silica: AEROSIL RX200 (manufactured by Nippon Aerosil, surface-treated with trimethylsilyl)

[0171] The polysiloxane ultrasonic coupling material solution was mixed according to the formula recorded in Table 1, and 1 part by mass of platinum catalyst PL-56 manufactured by Shin-Etsu Chemical Industry was added to 100 parts by mass of the solution, and the mixture was further mixed.

[0172] [Table 1]

[0173]

[0174] (Formation of polysiloxane ultrasonic coupling material film)

[0175] The aforementioned polysiloxane ultrasonic coupling material was applied to a Nippa (50μm thick) PET Separator SS1A release liner using a rod coater. After air drying for 10 minutes, it was baked in a hot air oven at 125°C for 10 minutes to harden, forming... Figure 1 The coupling membrane shown. After curing, a release liner made of Nippa PET Separator SS1A (50μm thickness) is applied to create a polysiloxane ultrasonic coupling membrane sandwiched between two release liners.

[0176] (Measuring the thickness of the contact layer in organisms)

[0177] The thickness of the ultrasonic coupling membrane prepared above was measured using a micrometer. The results are shown in Table 2.

[0178] (Formation of adhesive hydrogel coupling material membrane)

[0179] An adhesive hydrogel coupling material membrane is fabricated by attaching an acrylic adhesive with a thickness of approximately 50 μm to both sides of an EP-S-03 (3 mm thick) hydrated polyurethane gel pad from Yashima PROSEED.

[0180] The peeling backing on one side of the polysiloxane ultrasonic coupling material membrane is peeled off and attached to the adhesive gel coupling material membrane to fabricate a composite ultrasonic coupling material membrane. Figure 2 ).

[0181] (Measurement of ultrasonic signals)

[0182] As a handheld ultrasonic diagnostic device (diagnostic instrument) for measuring ultrasonic signals, the SONON 500L manufactured by Healcerion was used. The adhesive hydrogel ultrasonic coupling material membrane of the composite ultrasonic coupling material was side-attached to the probe surface of the ultrasonic diagnostic device, and the release liner of the polysiloxane ultrasonic coupling material was peeled off. Figure 3 ).

[0183] The application and removal of the laminated ultrasonic coupling material film with the attached polysiloxane ultrasonic coupling material film on the skin was repeated 10 times to confirm that the removal from the skin proceeded smoothly and that no peeling occurred between the polysiloxane ultrasonic coupling layer and the adhesive hydrogel ultrasonic coupling material film. Figure 4 ).

[0184] After determining the location of the carotid artery through 10 attachment and dissections, it was attached to the skin for ultrasound diagnosis at a frequency of 8.5 MHz.

[0185] After confirming that the polysiloxane ultrasonic coupling material membrane 1 could be successfully peeled off, the adhesive hydrogel ultrasonic coupling material membrane was attached to the skin for ultrasound diagnosis at a frequency of 8.5 MHz. Figure 5 ).

[0186] Will show Figure 14 The image shown is judged to be in good condition. Figure 15 The image was deemed defective.

[0187] The evaluation results of the composite ultrasonic coupling material membrane using the polysiloxane ultrasonic coupling material described in Table 1 are shown in Table 2.

[0188] [Table 2]

[0189]

[0190] As shown in Table 2, when the composite film of the polysiloxane ultrasonic coupling material film shown in the example, which is a polysiloxane rubber composed of component (A) with added polysiloxane oil of component (B), and an adhesive hydrogel ultrasonic coupling material film, is attached to the skin, multiple attachments and peels can be performed on the skin, resulting in good ultrasonic images. The polysiloxane ultrasonic coupling material film can be easily peeled off, and the adhesive hydrogel ultrasonic coupling material film can be applied to the skin after peeling off the polysiloxane ultrasonic coupling material film, resulting in good ultrasonic images. When the polysiloxane ultrasonic coupling material film without added polysiloxane oil of component (B) is combined with the adhesive hydrogel ultrasonic coupling material film, no ultrasonic images can be obtained (Comparative Example 1). In the case of coupling material consisting only of an adhesive water-soluble gel, good ultrasonic images can be obtained, but attachment and peeling on the skin cannot be performed (Comparative Example 2).

[0191] This specification contains the following specifications.

[0192] [1]: An ultrasonic coupling material composite membrane, which is an ultrasonic coupling material composite membrane inserted between the surface of an ultrasonic probe and the skin, characterized in that it comprises: a gel coupling material membrane composed of a water-containing gel; and a polysiloxane coupling material membrane containing a cross-linked polysiloxane resin and a polysiloxane oil without cross-linking points.

[0193] [2]: such as the ultrasonic coupling material composite membrane of [1], wherein the gel coupling material membrane has adhesive properties.

[0194] [3]: such as the ultrasonic coupling material composite film of [1] or [2], wherein,

[0195] The polysiloxane coupling material membrane is composed of a cured form of an addition-curing polysiloxane coupling material composition, which contains: (A) an alkenyl diorganopolysiloxane, (B) a polysiloxane oil without crosslinking points, (C) a SiH-based organohydrogen polysiloxane, and (D) a platinum group metal catalyst.

[0196] [4]: such as the ultrasonic coupling material composite film of [3], wherein the molar number of SiH groups in the (C) component divided by the molar number of alkenes in the (A) component is in the range of 0.5 to 20.

[0197] [5]: [3] or [4] of an ultrasonic coupling material composite film, wherein component (B) has a kinematic viscosity of 10 to 50,000 mm at 25°C. 2 A range of straight-chain or branched diorganopolysiloxanes without crosslinking points, alkenyl groups, or SiH groups.

[0198] [6]: An ultrasonic coupling material composite membrane, such as any one of [3] to [5], wherein the mass of component (B) divided by the total mass of component (A), component (B) and component (C) is in the range of 0.20 to 0.90.

[0199] [7]: The ultrasonic coupling material composite film of any one of [3] to [6], wherein, relative to the total 100 parts by mass of the components (A) to (C), it contains 0.1 to 10 parts by mass of dry silica.

[0200] [8]: An ultrasonic coupling material composite membrane as described in any of [1] to [7], wherein the thickness of the polysiloxane coupling material membrane is in the range of 10 to 5000 μm.

[0201] [9]: The ultrasonic coupling material composite membrane of any one of [1] to [8] further forms a membrane on both sides of the gel coupling material membrane, and then forms an adhesive membrane on its outer side.

[0202]

[10] : An ultrasonic coupling material composite membrane as described in any of [1] to [8], wherein a release liner membrane is further provided on one or both sides of the ultrasonic coupling material composite membrane.

[0203]

[11] : An examination method (excluding methods of performing surgery, treatment or diagnosis on a person), which is an ultrasonic examination method using an ultrasonic coupling material composite membrane as described in any of [1] to [9], characterized in that:

[0204] The ultrasonic coupling material composite membrane is inserted between the ultrasonic probe surface and the subject, with the gel coupling material membrane of the composite membrane facing the surface of the ultrasonic probe and the polysiloxane coupling material membrane of the composite membrane facing the subject.

[0205] The polysiloxane coupling material membrane is brought into contact with the object being inspected to locate the site for ultrasonic examination.

[0206]

[12] : As in the inspection method of

[11] , where,

[0207] Repeated contact and peeling with the subject, or sliding on the subject to locate the area to be examined by ultrasound.

[0208]

[13] : Such as the inspection methods in

[11] or

[12] , wherein,

[0209] After peeling off the polysiloxane coupling material membrane, the gel coupling material membrane is brought into contact with and fixed to the subject for continuous ultrasonic testing.

[0210]

[14] : A method for forming a laminated structure, characterized in that an addition-curing polysiloxane coupling material composition is coated on a release liner film and heated to cure it to form a polysiloxane coupling material film; then the polysiloxane coupling material film is attached to a gel coupling material film composed of a water-containing gel, and an ultrasonic probe is attached to the side of the gel coupling material film opposite to the side in contact with the polysiloxane coupling material film to form a laminated structure.

[0211] The addition-curing polysiloxane coupling material composition contains: (A) an alkenyl diorganopolysiloxane, (B) a polysiloxane oil without crosslinking points, (C) a SiH-based organohydrogen polysiloxane, and (D) a platinum group metal catalyst.

[0212]

[15] : The method of forming a layered structure as in

[14] , wherein the gel coupling material film is attached to the ultrasonic probe by peeling the polysiloxane coupling material film from the gel coupling material film.

[0213] Furthermore, the present invention is not limited to the embodiments described above. The embodiments described above are illustrative examples, and any technical solutions having substantially the same structure and achieving the same effect as those described in the claims of the present invention are included within the technical scope of the present invention.

[0214] Explanation of reference numerals in the attached figures

[0215] 1: Polysiloxane coupling materials (membranes)

[0216] 2: Gel-coupled materials (membranes)

[0217] 3: Ultrasonic probe

[0218] 4: Skin

[0219] 5: Membrane

[0220] 6: Adhesive film

[0221] 7: Ultrasound

[0222] 10: Ultrasonic diagnostic instrument

[0223] 11: Support (Removable Pad)

[0224] 12: Coupling materials (membranes)

Claims

1. An ultrasonic coupling material composite membrane, which is inserted between the surface of an ultrasonic probe and the skin, characterized in that it comprises: a gel coupling material membrane composed of a water-containing gel; and a polysiloxane coupling material membrane containing a cross-linked polysiloxane resin and a polysiloxane oil without cross-linking points.

2. The ultrasonic coupling material composite membrane according to claim 1, wherein, The gel-coupled material membrane has adhesive properties.

3. The ultrasonic coupling material composite membrane according to claim 1, wherein, The polysiloxane coupling material membrane is composed of a cured form of an addition-curing polysiloxane coupling material composition, which contains: (A) an alkenyl diorganopolysiloxane, (B) a polysiloxane oil without crosslinking points, (C) a SiH-based organohydrogen polysiloxane, and (D) a platinum group metal catalyst.

4. The ultrasonic coupling material composite membrane according to claim 3, wherein, The value obtained by dividing the number of moles of SiH groups in component (C) by the number of moles of alkenes in component (A) is in the range of 0.5 to 20.

5. The ultrasonic coupling material composite membrane according to claim 3, wherein, Component (B) has a kinematic viscosity of 10–50,000 mm at 25°C. 2 A range of straight-chain or branched diorganopolysiloxanes without crosslinking points, alkenyl groups, or SiH groups.

6. The ultrasonic coupling material composite membrane according to claim 3, wherein, The value obtained by dividing the mass of component (B) by the total mass of component (A), component (B) and component (C) is in the range of 0.20 to 0.

90.

7. The ultrasonic coupling material composite membrane according to claim 3, wherein, Relative to the total of 100 parts by mass of components (A) to (C), it contains 0.1 to 10 parts by mass of dry silica.

8. The ultrasonic coupling material composite membrane according to claim 1, wherein, The thickness of the polysiloxane coupling material membrane ranges from 10 to 5000 μm.

9. The ultrasonic coupling material composite membrane according to claim 1, further comprising forming membrane sheets on both sides of the gel coupling material membrane, thereby forming an adhesive membrane on its outer side.

10. The ultrasonic coupling material composite membrane according to claim 1, wherein, The ultrasonic coupling material composite membrane has a release liner membrane on one or both sides.

11. An examination method (excluding methods for performing surgery, treatment, or diagnosis on a person), comprising an ultrasonic examination method using an ultrasonic coupling material composite membrane according to any one of claims 1 to 9, characterized in that: The ultrasonic coupling material composite membrane is inserted between the ultrasonic probe surface and the subject, with the gel coupling material membrane of the composite membrane facing the surface of the ultrasonic probe and the polysiloxane coupling material membrane of the composite membrane facing the subject. The polysiloxane coupling material membrane is brought into contact with the object being inspected to locate the site for ultrasonic examination.

12. The inspection method according to claim 11, wherein, Repeated contact and peeling with the subject, or sliding on the subject to locate the area to be examined by ultrasound.

13. The inspection method according to claim 11, wherein, After peeling off the polysiloxane coupling material membrane, the gel coupling material membrane is brought into contact with and fixed to the subject for continuous ultrasonic testing.

14. A method for forming a layered structure, characterized in that, An addition-curing polysiloxane coupling material composition is coated onto a release liner membrane and then heat-cured to form a polysiloxane coupling material membrane. This polysiloxane coupling material membrane is then attached to a gel coupling material membrane composed of an aqueous gel. An ultrasonic probe is attached to the side of the gel coupling material membrane opposite to the side in contact with the polysiloxane coupling material membrane, thus creating a laminated structure. The addition-curing polysiloxane coupling material composition contains: (A) an alkenyl diorganopolysiloxane, (B) a polysiloxane oil without crosslinking points, (C) a SiH-based organohydrogen polysiloxane, and (D) a platinum group metal catalyst.

15. The method for forming a stacked structure according to claim 14, wherein, The gel coupling material membrane is attached to the ultrasonic probe by peeling it off from the gel coupling material membrane.

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