TW202410849A - Simulated mucus-coated mucosal tissue model - Google Patents

Abstract

The present invention provides a simulated mucus-coated mucosal tissue model and an organ model, a medical skill training method using the model, a method for manufacturing the model, a kit and a device containing the model, and a lubricating composition for coating the mucosal tissue model. The present invention produces a simulated mucus-coated mucosal tissue model for medical manual skill training, wherein the mucosal surface of the simulated mucosal tissue of at least a portion of the mucosal tissue of the mucosal tissue model simulating a biological body is coated with a lubricating composition, the volume resistivity of the lubricating composition is 1.0E+00～1.0E+05(1.0～1.0×10 ⁵ )Ω·cm, and the viscosity at 25°C measured by the measurement method specified in JIS Z8803 is 1.0E+00～1.0E+05(1.0～1.0×10 ⁵ )mPa·s.

Description

Simulated mucus-coated mucosal tissue model

The present invention relates to a simulated mucus-coated mucosal tissue model and an organ model, a medical skill training method using the model, a method for manufacturing the model, a kit and a device containing the model, and a lubricating composition for coating the mucosal tissue model.

In recent years, expectations have been high for less invasive surgeries that put less strain on the human body and that can be expected to recover early, such as surgery using an endoscope or laparoscopy, and the number of cases has increased. For example, by removing a tumor formed in the mucosal layer inside an organ under an endoscope (endoscopic submucosal excision), surgery can be performed with a smaller wound than with conventional open surgery. In addition, by stopping bleeding in the digestive tract under an endoscope (endoscopic hemostasis), shock caused by bleeding can be prevented and emergency surgery can be avoided. Therefore, for patients, the burden on the body is reduced, the hospital stay is shortened, and they can be expected to return to society sooner.

Therefore, in response to the increasing demand for models for doctors or medical students to practice their surgical skills in endoscopy or laparoscopy, the industry has proposed a model for medical surgical skills training (patent documents 1, 2, 3) in order to improve the technology and the quality of medical behavior. In addition, there are more cases of using surgical energy devices as the instruments used.

Patent document 1: Japanese Patent Publication No. 2006-116206 Patent document 2: Japanese Patent Publication No. 2008-197483 Patent document 3: Japanese Patent Publication No. 2015-085017

When using an energy device such as a surgical electric knife to perform incision or hemostasis on the mucosal tissue of a living body, the treatment is performed using the condition that the mucus covering the mucosal tissue is heated and bubbles are generated as a standard for completion of the power supply. Previously, in the training of such treatments, for example, the condition that thermoplastic resins such as styrene elastomers, which are the base materials of medical manual training models simulating organs or tissues, melt due to power supply and heating was used as a substitute for the standard for completion of the power supply of the energy device. However, due to the melting of thermoplastic resins, not only can the behavior represented by the generation of bubbles in mucus not be reproduced, but the deformation of the base material of the model itself caused by heating is also significant, and it is impossible to reproduce the condition of the tissue or organ and the behavior of the mucus when the energy device is used to treat the mucosal tissue of a living body. In addition, due to excessive heating in order to reproduce the behavior of mucus, there is also a risk of deformation or failure of energy equipment (especially treatment tools such as pliers). Therefore, the industry seeks a tissue model or organ model that can be used for training the treatment of mucosal tissue using energy equipment.

The subject of the present invention is to provide a simulated mucus-coated mucosal tissue model and an organ model, a medical skill training method using the model, a method for manufacturing the model, a kit and a device containing the model, and a lubricating composition for coating the mucosal tissue model. The simulated mucus-coated mucosal tissue model and the organ model can reproduce the behavior of mucus in the treatment of the mucosal tissue of a biological body using an energy device, and/or can reduce the risk of deformation or failure of the energy device during medical skill training.

The inventors have studied various methods and found that by coating the mucosal surface of a mucosal tissue model simulating the mucosal tissue of a living body with a lubricating composition, the behavior of mucus in the treatment of the mucosal tissue of a living body using an energy device can be reproduced, thereby completing the present invention. The lubricating composition has a volume resistivity of 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )Ω·cm, and a viscosity at 25°C measured by the measurement method specified in JIS Z8803 (meaning JIS Z8803:2011) is 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )mPa·s.

The present invention relates to the following. [1] A simulated mucus-coated mucosal tissue model for medical skill training, wherein the mucosal surface of the simulated mucosal tissue of at least a portion of the mucosal tissue of the mucosal tissue model simulating a biological body is coated with a lubricating composition, the lubricating composition has a volume resistivity of 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )Ω·cm, and a viscosity at 25°C measured by the measurement method specified in JIS Z8803 is 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )mPa·s. [2] A simulated mucus-coated mucosal tissue model as described in [1], comprising a simulated blood vessel connected to a device for supplying simulated blood. [3] A simulated mucus-coated mucosal tissue model as described in [1] or [2], wherein the medical technique comprises incision or hemostasis of mucosal tissue using an energy device. [4] A simulated mucus-coated organ model for medical technique training, comprising a simulated mucus-coated mucosal tissue model as described in any one of [1] to [3]. [5] A simulated mucus-coated organ model as described in [4], comprising a simulated blood vessel connected to a device for supplying simulated blood. [6] A simulated mucus-covered organ model as described in [4] or [5], wherein the medical technique comprises the incision or hemostasis of mucosal tissue using an energy device. [7] A medical technique training method using a simulated mucus-covered mucosal tissue model as described in any one of [1] to [3]. [8] A medical technique training method using a simulated mucus-covered organ model as described in any one of [4] to [6]. [9] A medical technique training method as described in [7] or [8], wherein the medical technique comprises the incision or hemostasis of mucosal tissue using an energy device. [10] A method for manufacturing a simulated mucus-coated mucosal tissue model for medical skill training, comprising the step of coating the surface of the simulated mucosal surface of at least a portion of the mucosal tissue of the mucosal tissue model simulating the mucosal tissue of a biological body with a lubricating composition, wherein the volume resistivity of the lubricating composition is 1.0E+00～1.0E+05(1.0～1.0×10 ⁵ )Ω·cm, and the viscosity at 25°C measured by the measurement method specified in JIS Z8803 is 1.0E+00～1.0E+05(1.0～1.0×10 ⁵ )mPa·s. [11] The manufacturing method described in [10], wherein the mucosal tissue model includes a simulated blood vessel connected to a device for supplying simulated blood. [12] A method of manufacture as described in [10] or [11], wherein the medical procedure comprises incision or hemostatic treatment of mucosal tissue using an energy device. [13] A method for producing a simulated mucus-coated organ model for medical manual skill training, comprising the step of coating the mucosal surface of the simulated mucosal tissue of an organ model comprising a mucosal tissue model that simulates at least a portion of the mucosal tissue of a biological body with a lubricating composition, wherein the lubricating composition has a volume resistivity of 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )Ω·cm and a viscosity of 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )mPa·s at 25°C as measured by the measurement method specified in JIS Z8803. [14] The manufacturing method as described in [13], wherein the simulated mucus-coated organ model comprises a simulated blood vessel connected to a device for supplying simulated blood. [15] The manufacturing method as described in [13] or [14], wherein the medical procedure comprises the incision or hemostasis of mucosal tissue using an energy device. [16] A medical skill training kit, comprising a lubricating composition and a mucosal tissue model, wherein the lubricating composition has a volume resistivity of 1.0E+00-1.0E+05 (1.0-1.0×10 ⁵ )Ω·cm, and a viscosity at 25°C measured by the measurement method specified in JIS Z8803 of 1.0E+00-1.0E+05 (1.0-1.0×10 ⁵ )mPa·s, and the mucosal tissue model simulates at least a portion of the mucosal tissue of a living body. [17] A medical skill training kit as described in [16], wherein the mucosal tissue model comprises a simulated blood vessel connected to a device for supplying simulated blood. [18] A medical skill training kit as described in [16] or [17], wherein the medical skill comprises incision or hemostasis of mucosal tissue using an energy device. [19] A medical skill training kit comprising a lubricating composition and an organ model, wherein the lubricating composition has a volume resistivity of 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ ) Ω·cm and a viscosity at 25°C measured by the measurement method specified in JIS Z8803 of 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ ) mPa·s, and the organ model comprises a mucosal tissue model that simulates at least a portion of the mucosal tissue of a biological body. [20] A medical skill training kit as described in [19], wherein the organ model includes a simulated blood vessel connected to a device for supplying simulated blood. [21] A medical skill training kit as described in [19] or [20], wherein the medical skill includes the incision or hemostasis of mucosal tissue using an energy device. [22] A medical skill training device, which comprises a simulated mucus-covered organ model as described in any one of [4] to [6], and an organ model simulating one or more other types of organs. [23] A lubricating composition for coating a mucosal tissue model, wherein the volume resistivity is 1.0E+00-1.0E+05 (1.0-1.0×10 ⁵ )Ω·cm, and the viscosity at 25°C measured by the measurement method specified in JIS Z8803 is 1.0E+00-1.0E+05 (1.0-1.0×10 ⁵ )mPa·s, and the use thereof is to coat the surface of the mucosal surface of the simulated mucosal tissue in the mucosal tissue model. [24] A lubricating composition for coating a mucosal tissue model as described in [23], wherein the mucosal tissue model comprises a simulated blood vessel connected to a device for supplying simulated blood. [25] The mucosal tissue model as described in [23] or [24] is coated with a lubricating composition, which is used to reproduce the behavior of mucus in the treatment of mucosal tissue of a living body using an energy device in the mucosal tissue model. [26] The mucosal tissue model as described in [25] is coated with a lubricating composition, wherein the treatment of mucosal tissue of a living body using an energy device includes incision or hemostasis of the mucosal tissue. [27] A use of a lubricating composition for coating the surface of a mucosal surface simulating mucosal tissue in a mucosal tissue model (preferably for coating on the surface), wherein the volume resistivity of the lubricating composition is 1.0E+00～1.0E+05 (1.0～1.0×10 ⁵ )Ω·cm, and the viscosity at 25°C measured by the measurement method specified in JIS Z8803 is 1.0E+00～1.0E+05 (1.0～1.0×10 ⁵ )mPa·s.

According to the present invention, a simulated mucus-coated mucosal tissue model and an organ model, a medical skill training method using the model, a method for manufacturing the model, a kit and a device containing the model, and a lubricating composition for covering the mucosal tissue model can be provided. The simulated mucus-coated mucosal tissue model and the organ model can reproduce the behavior of mucus during the treatment of the mucosal tissue of a biological body using an energy device, and/or can reduce the risk of deformation or failure of the energy device during medical skill training.

Hereinafter, one embodiment of the present invention is described in detail. The present invention is not limited to the following embodiments, and can be implemented with appropriate changes within the scope that does not hinder the effect of the present invention. Each structure in each embodiment and its combination are examples, and the addition, omission, replacement, and other changes of the structure can be appropriately made within the scope that does not deviate from the gist of the present invention. The present invention is not limited by the embodiments, but only by the scope of the patent application. Each aspect disclosed in this specification can be combined with any other features disclosed in this specification. When a specific description recorded in one embodiment is also applicable to other embodiments, the description may be omitted in other embodiments. In the present invention, the expression "X to Y" about the numerical range means "above X and below Y".

==First embodiment (simulated mucus-coated mucosal tissue model)== The mucosal tissue model of this embodiment is a simulated mucus-coated mucosal tissue model for medical skill training, wherein the mucosal surface of the simulated mucosal tissue of at least a portion of the mucosal tissue of the mucosal tissue model simulating the mucosal tissue of a biological body is coated with a lubricating composition, the volume resistivity of the lubricating composition is 1.0E+00～1.0E+05(1.0～1.0×10 ⁵ )Ω·cm, and the viscosity at 25°C measured by the measurement method specified in JIS Z8803 is 1.0E+00～1.0E+05(1.0～1.0×10 ⁵ )mPa·s.

In the simulated mucus-coated mucosal tissue model of the present embodiment, the surface of the mucosal surface of the simulated mucosal tissue of the mucosal tissue model is coated with a lubricating composition. The coating of the mucosal surface of the simulated mucosal tissue with the lubricating composition can be performed by any coating method, for example: using fingers or a spatula to spread the lubricating composition on the surface of the mucosal surface of the simulated mucosal tissue; immersing the surface of the mucosal surface of the simulated mucosal tissue in the lubricating composition; transferring the lubricating composition from a transfer material containing the lubricating composition to the surface of the mucosal surface of the simulated mucosal tissue, etc. In the simulated mucus-coated mucosal tissue model of the present embodiment, it is preferred to apply the lubricating composition to the mucosal surface of the simulated mucosal tissue of the mucosal tissue model. The mucosal surface of the mucosal tissue refers to the mucosal epithelial side of the mucosal tissue, i.e., the side of the biological tissue where mucus cells such as mucus-secreting cells exist in the intestines and the like and are covered with mucosa.

Here, in this specification, when referred to as a "mucosal tissue model", it refers to a model in which the surface of at least a portion of the simulated mucosal surface of the mucosal tissue simulating a biological body is not coated with a lubricating composition, and when referred to as a "simulated mucus-coated mucosal tissue model", it refers to a mucosal tissue model in a state of being coated with a lubricating composition.

[Lubricating Composition] In the present embodiment, the lubricating composition has a volume resistivity of 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ ) Ω·cm and a viscosity of 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ ) mPa·s at 25°C as measured by the measurement method specified in JIS Z8803.

The components and composition of the lubricating composition are not limited to the following ranges: the volume resistivity is 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )Ω·cm, and the viscosity at 25°C measured by the measurement method specified in JIS Z8803 is 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )mPa·s. Examples of the components include: low molecular weight compounds such as water, sodium chloride, magnesium chloride, potassium chloride, sodium hydroxide, sodium dihydrogen phosphate, sodium phosphate, glycerin, propylene glycol, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, and butyl p-hydroxybenzoate; water-absorbing polymers such as hydrogenated castor oil, 12-hydroxystearic acid, glucono-δ-lactone, and sodium polyacrylate; Polyethylene glycol, polypropylene glycol, hyaluronic acid, alginic acid, carrageenan, dextrin, safflower gum, guar gum, glucosaminoglycan, collagen, water-soluble vinyl polymer (including carboxyvinyl polymer, polyvinyl alcohol), hydroxypropyl methylcellulose, methylcellulose, polyacrylic acid, polymethacrylic acid, hydroxyethyl cellulose and other water-soluble polymers, etc., can also contain one or more of them. In addition, the lubricating composition can also further contain one or more electrolytes, carbon nanomaterials, conductive polymers, conductive materials such as metal fillers, preservatives, fragrances, pigments, anesthetic ingredients, pH adjusters, dispersants, thickeners (including thixotropic agents, anti-sedimentation agents, anti-sagging agents), surfactants, antioxidants, etc.

A lubricating composition having a volume resistivity of 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )Ω·cm and a viscosity at 25°C of 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )mPa·s as measured by the measurement method specified in JIS Z8803 can be prepared by adjusting the components contained in the composition and the content of each component, and measuring the volume resistivity and viscosity to confirm whether they are within the above ranges.

Here, the volume resistivity can be calculated by AC impedance measurement at a measurement temperature of 25°C. Specifically, the test sample is placed in a liquid measurement tank with a diameter of 13 mm and a thickness of 5 mm, and the metal terminals at both ends of the tank in contact with the test sample are connected to the terminals of the AC impedance measurement device (Solartron SI 1287, frequency response analyzer 1252A manufactured by Dongyang Technology Co., Ltd.). The resistivity of the tank can be measured at a temperature of 25°C using a small environmental tester (manufactured by ESPEC Co., Ltd., model: SU-241), and the result is divided by the thickness of 5 mm to calculate the volume resistivity.

The viscosity can be measured by the measurement method specified in JIS Z8803, using a rheometer (MCR-92 manufactured by Anton Paar) with a 50 mm diameter cone, a measurement temperature of 25°C, and a shear rate of 10/s.

As a more specific example, the lubricating composition may be a sodium chloride aqueous solution or a sodium polyacrylate aqueous solution. For example, when the lubricating composition is a sodium chloride aqueous solution, sodium chloride may be added to distilled water and stirred. In this case, by preparing a 5.0E-07 to 4.0E+00 (5.0×10 ^-7 to 4.0) M aqueous solution, the volume resistivity may be 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ ) Ω·cm, and the viscosity at 25°C measured by the measurement method specified in JIS Z8803 may be 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ ) mPa·s. The sodium chloride aqueous solution may be, for example, 1.7E+00 (1.7) M or 8.6E-06 (8.6×10 ^-6 ) M. For example, when the lubricating composition is a sodium polyacrylate aqueous solution, ARON (registered trademark) A-20L manufactured by Toagosei Co., Ltd. may be used without dilution, or distilled water may be added to ARON A-20L and then stirred. At this time, by preparing an aqueous solution with a concentration of ARON A-20L in distilled water of 1 to 100 mass % (wt%), the volume resistivity can be 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )Ω·cm, and the viscosity at 25°C measured by the measurement method specified in JIS Z8803 is 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )mPa·s. The sodium polyacrylate aqueous solution can be, for example, 10 wt% or 100 wt% in terms of the concentration of ARON A-20L in distilled water.

Furthermore, various commercially available medical lubricating gels and ultrasound examination gels have a volume resistivity of 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )Ω·cm and a viscosity at 25°C of 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )mPa·s as measured by the measurement method specified in JIS Z8803. Regardless of their component compositions, they can be used as the lubricating composition of the present embodiment. Examples of such medical lubricating gels include Sterile Lubricating Gel (Catalog No. SLT-612-10) manufactured by Boston Scientific and ECHO JELLY MORE (registered trademark), a gel for ultrasound examination manufactured by FUJIFILM Healthcare Co., Ltd.

The volume resistivity of the lubricating composition is 1.0E+00-1.0E+05 (1.0-1.0×10 ⁵ )Ω·cm, preferably 1.0E+00-8.0E+04 (1.0-8.0×10 ⁴ )Ω·cm, more preferably 5.0E+00-8.0E+04 (5.0-8.0×10 ⁴ )Ω·cm, and further preferably 8.2E+00-8.0E+04 (8.2-8.0×10 ⁴ )Ω·cm. In the case of 8.2E+00 to 8.0E+04 (8.2 to 8.0×10 ⁴ )Ω·cm, it may be 8.2E+00 Ω·cm or more and less than 8.0E+04 Ω·cm (8.2 Ω·cm or more and less than 8.0×10 ⁴ Ω·cm), 8.2E+00 to 9.6E+02 (8.2 to 9.6×10 ² )Ω·cm, and further 1.9E+01 to 9.6E+02 (1.9×10 ¹ to 9.6×10 ² )Ω·cm.

The viscosity of the lubricating composition at 25°C measured by the measurement method specified in JIS Z8803 is 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ ) mPa·s, preferably 1.0E+02 to 5.0E+04 (1.0×10 ² to 5.0×10 ⁴ ) mPa·s, more preferably 1.0E+03 to 5.0E+04 (1.0×10 ³ to 5.0×10 ⁴ ) mPa·s, and further preferably 5.0E+03 to 5.0E+04 (5.0×10 ³ to 5.0×10 ⁴ ) mPa·s. In the case of 5.0E+03 to 5.0E+04 (5.0×10 ³ to 5.0×10 ⁴ ) mPa·s, it may be 9.0E+03 to 8.0E+04 (9.0×10 ³ to 8.0×10 ⁴ ) mPa·s, or 9.0E+03 to 2.6E+04 (9.0×10 ³ to 2.6×10 ⁴ ) mPa·s.

The volume resistivity of the lubricating composition and the viscosity at 25°C measured by the measuring method specified in JIS Z8803 are 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )Ω·cm and 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )mPa·s, respectively, preferably 1.0E+00 to 8.0E+04 (1.0 to 8.0×10 ⁴ )Ω·cm and 1.0E+02 to 5.0E+04 (1.0×10 ² to 5.0×10 ⁴ )mPa·s. More preferable ranges of the volume resistivity and viscosity are as described above, respectively, and any ranges of the volume resistivity and viscosity may be combined.

By setting the volume resistivity of the lubricating composition to be in the range of 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )Ω·cm, and the viscosity of the lubricating composition at 25°C measured by the measurement method specified in JIS Z8803 to be in the range of 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )mPa·s, the lubricating composition coating the surface of the simulated mucosal surface in the simulated mucus-coated mucosal tissue model of the present embodiment can easily reproduce the behavior of mucus in the treatment of the mucosal tissue of a living body using energy equipment. In addition, when the lubricating composition is applied to simulate the situation where the surface of the mucosal surface is coated with the lubricating composition, the coating adaptability when applied to the mucosal tissue model is easily improved. Furthermore, the simulated mucus-coated mucosal tissue model according to the present embodiment can reduce the risk of deformation or failure of the energy device caused by the thermoplastic resin used in the previous medical skill training being energized and heated. Here, the behavior of the mucus in the treatment of the mucosal tissue of the organism using the energy device is reproduced, for example, to reproduce the continuous bubble generation. Furthermore, coating compatibility refers to the property that the lubricating composition has no excessive stickiness (sticky feeling) when applied to the mucosal tissue model and easily remains on the surface of the mucosal tissue model after application.

In one embodiment, the thickness of the lubricating composition applied to the simulated mucus-coated mucosal tissue model (the lubricating composition coating the surface of the simulated mucosal surface) is preferably 0.01 to 3.0 mm, more preferably 0.05 to 2.5 mm, and further preferably 0.05 to 1.0 mm. In the case of 0.05 to 1.0 mm, it can be 0.1 mm, 0.5 mm, or 1.0 mm.

By making the thickness of the lubricating composition applied to the simulated mucus-coated mucosal tissue model (the lubricating composition covering the surface of the simulated mucosal surface) in the range of 0.01 to 3.0 mm, the lubricating composition in the simulated mucus-coated mucosal tissue model in the present embodiment can easily reproduce the behavior of mucus during the treatment of the mucosal tissue of a living body using an energy device.

[Mucosal tissue model] In this embodiment, the "mucosal tissue" of the mucosal tissue model is not limited, as long as it is a tissue that can secrete mucus in the living body of an animal, such as at least a part of the tissue in the digestive organs, urinary organs, reproductive organs, respiratory organs, etc. Here, as digestive organs, examples include: oral cavity, pharynx, esophagus, stomach, duodenum, small intestine, large intestine, rectum, anus, etc., as urinary organs, examples include: ureter, bladder, urethra, etc., as reproductive organs, examples include: fallopian tube, uterus, vagina, vas deferens, penis, urethra, etc., as respiratory organs, examples include: nasal cavity, trachea, bronchi, etc., but are not limited to them. There is no limitation on the mucosal tissue model. It can be a model that simulates the mucosal tissue of any animal species, such as mammals, birds, reptiles, amphibians, fish, etc. including humans. The practitioner can choose appropriately according to the needs of medical skill training.

Here, the mucosal tissue model can be selected by the industry from known mucosal tissue models without limitation, as long as it is a model that simulates mucosal tissue, for example, various models made of soft resin materials (dry materials) such as silicone, urethane elastomer, styrene elastomer as the main material; various models made of aqueous gel (wet materials) obtained from polyvinyl alcohol solution, protein solution, polysaccharide solution as the main material, etc. The mucosal tissue model is not limited, and can be a single-layer structure or a multi-layer structure including one or more materials according to the type of tissue.

The shape of the mucosal tissue model can be selected according to the type of medical skill being trained, for example, it can have any shape selected from circular, elliptical, polygonal or amorphous. The mucosal tissue model can be formed by a known molding method, and can be formed as a whole or can be formed separately. For example, when using an inner mold (core) and an outer mold, and casting into the space between them, sometimes when removing the inner mold, an incision is cut in the resin molded body and the inner mold is removed from it. At this time, the incision can also be connected to complete the mucosal tissue model. In addition, the mucosal tissue model can be formed by hot pressing molding, vacuum pressure molding, etc., using a positive mold and a negative mold, and multiple mucosal tissue parts can be formed separately by injection molding, etc., and then connected to complete the mucosal tissue model.

The maximum width of the mucosal tissue model in a direction perpendicular to the thickness direction can be selected according to the type of medical skill being trained, for example, it can be set to a range corresponding to the spread of a general ulcer, for example, it can be in the range of 10 to 150 mm. The thickness of the mucosal tissue model is not particularly limited, and can be about 1 to 30 mm or about 2 to 20 mm.

In one embodiment, the mucosal tissue model is prepared by adding 400 parts by mass of oil, 30 parts by mass of a copolymer of a hydrophobic polymer and a hydrophilic polymer, and 100 parts by mass of an ionic liquid to 100 parts by mass of a hydrogenated styrene-based thermoplastic elastomer, and then storing the mixture for more than 12 hours to allow the mixture to fully penetrate. The mucosal tissue model may be a sheet material, which is kneaded at 180°C and 100 rpm for 15 minutes using a segmented mixer (Labo Plastomill KF70V2 manufactured by Toyo Seiki Co., Ltd.), and then formed into a sheet material having a width of 100 mm, a length of 100 mm, and a thickness of 2 mm by a heat pressing method (180°C, a time of 5 minutes, and a pressure of 50 kg/cm ² ). Here, each component may be as described below. (A) Hydrogenated styrene-based thermoplastic elastomer Hydrogenated styrene-based thermoplastic elastomer: SEEPS (SEPTON 4055, manufactured by Kuraray Co., Ltd.) (MFR (melt flow rate) (temperature 230°C, load 2.16 kg) is 0.0 g/10 min (0.0 g/10 min means no flow), styrene content is 30% by mass, hydrogenation rate is 90 mol% or more) (B) Oil · Paraffin oil (Diana Process Oil PW90, manufactured by Idemitsu Kosan Co., Ltd.) (C) Copolymer of hydrophobic polymer and hydrophilic polymer · C-1: Polyolefin/polyether copolymer (PELECTRON PVL, manufactured by Sanyo Chemical Industries, Ltd.) (MFR (measured at 190°C, load 2.16 kg) is 8 to 15 g/10 min) ·C-2: Polyethylene glycol/polypropylene glycol copolymer (Pluronic (registered trademark) L-34, manufactured by ADEKA) (average molecular weight 1700, ethylene oxide ratio 40%, viscosity at 25°C 300 mPa·s) (D) Ionic liquid ·CIL-312 (manufactured by Japan Carlit)

In one embodiment, the mucosal tissue model may include a simulated blood vessel connected to a device that can supply simulated blood. In this case, the simulated mucus-coated mucosal tissue model may include a simulated blood vessel connected to a device that can supply simulated blood. For example, the simulated blood vessel is a path on the surface of the simulated mucosal tissue of the mucosal tissue model used to supply simulated blood to the mucosal tissue model during hemostasis training, and can penetrate the mucosal tissue model. As any device that can supply simulated blood, for example, a tubular pump or a syringe can be used. The simulated blood vessel has a tubular substrate layer and a conductive layer arranged on the outer surface of the substrate layer, and can be a tubular structure that can be energized by an energy device. The conductive layer may not exist on the entire surface of the substrate layer, but may exist in the portion that is energized. The simulated blood vessel can have a surface resistivity of 1.0×10 ⁰ Ω/□ or more and 1.0×10 ⁶ Ω/□ or less at the portion where the conductive layer is disposed. The surface resistivity value can be measured at 23±1°C using LORESTA GX (MCP-T700) manufactured by Nittoseiko Analytech Co., Ltd. in accordance with JIS C2139. During the measurement, the thermoplastic resin composition can be press-formed at 160-200°C to form a 2.5 cm×2.5 cm, 1.0 mm thick resin sheet, and the specimen with the conductive layer formed on the surface can be used for evaluation.

Here, the simulated mucus-coated mucosal tissue model of the present embodiment is used as a simulated mucus-coated tissue sheet model, and can simulate the mucus-coated mucosal tissue model alone for medical skill training, or can also be used for medical skill training when installed in various organ models with mucosal tissue in biological bodies such as digestive organs, urinary organs, reproductive organs, and respiratory organs. When installed in an organ model for use, the simulated mucus-coated mucosal tissue model can be embedded in a mounting portion provided in the organ model, or can be attached to the inner wall of the organ model. The mounting portion provided in the organ model can be a frame or a recess formed by a part of the wall being missing, or a fixture for mounting the mucus-coated mucosal tissue model can be installed on the inner wall of an organ model such as a digestive organ. The simulated mucus-coated mucosal tissue model can be attached to the inner wall of the organ model using adhesives, adhesives, double-sided tape, etc.

[Medical skill training] In this implementation method, medical skill training is used to improve the skills of doctors or medical students and improve the quality of medical behavior, such as medical skill training under endoscopic observation or medical skill training under ultrasound observation.

In one embodiment, the medical procedure is the treatment of mucosal tissue using an energy device. Examples of energy devices include: high-frequency hemostatic forceps, surgical electric scalpels, ultrasonic scalpels, high-frequency radio frequency scalpels, thermal probes, microwave scalpels, laser scalpels, etc. As a preferred example of medical procedure, the treatment of mucosal tissue incision and/or hemostasis using an energy device can be exemplified, and more specifically, endoscopic mucosal resection, endoscopic submucosal peeling, endoscopic hemostasis, etc. can be exemplified. In one embodiment, when the simulated mucus-coated mucosal tissue model includes a simulated blood vessel connected to a device that can supply simulated blood, the medical technique can be to stop bleeding that is assumed to be from the simulated blood vessel.

==The second implementation method (simulated mucus-covered organ model)== The organ model of this implementation method is a simulated mucus-covered organ model for medical skill training that includes the simulated mucus-covered mucosal tissue model of the first implementation method.

The simulated mucus-coated mucosal tissue model of the first embodiment is used as a simulated mucus-coated tissue sheet model. The simulated mucus-coated mucosal tissue model can be used alone for medical skill training, or it can be used for medical skill training when installed in an organ model of various organs such as digestive organs, urinary organs, reproductive organs, and respiratory organs.

The simulated mucus-coated organ model of this embodiment can be, for example, the simulated mucus-coated mucosal tissue model of the first embodiment installed in a digestive organ, urinary organ, reproductive organ, respiratory organ, or other organism having mucosal tissue, or an organ model integrally contained therein. The organ model is preferably made to simulate the shape of each organ. The organ model is not limited and can be a model simulating the organ of any animal species, for example, it can be an organ model of any animal species including mammals, birds, reptiles, amphibians, fish, etc. The practitioner can choose appropriately according to the needs of medical skill training.

Here, in this specification, when referred to as an "organ model", it refers to a model in which the surface of the simulated mucosal surface is not coated with a lubricating composition, and when referred to as a "simulated mucus-coated mucosal tissue model", it refers to an organ model including a mucosal tissue model in which the surface of the simulated mucosal surface is coated with a lubricating composition.

The organ model can be formed by a known forming method in the same manner as the forming of the mucosal tissue model described in the first embodiment. Here, the organ model can be formed by forming the mucosal tissue model and the organ model having the mucosal tissue model as a whole, or the mucosal tissue model and the organ model can be formed separately and the mucosal tissue model can be mounted on the organ model by the method described in the first embodiment before the medical skill training. In the case where the mucosal tissue model and the organ model are formed as a whole, at least a portion of the mucosal tissue model can be coated with a lubricating composition after the forming to complete the simulated mucus-coated organ model. When the mucosal tissue model and the organ model are formed separately, the mucosal tissue model can be coated with a lubricating composition before being mounted on the organ model to complete the simulated mucus-coated organ model, or the mucosal tissue model can be coated with a lubricating composition after being mounted on the organ model to complete the simulated mucus-coated organ model.

In one embodiment, the simulated mucus-covered organ model may include a simulated blood vessel connected to a device for supplying simulated blood. The simulated mucus-covered organ model may include a simulated blood vessel connected to a device for supplying simulated blood in a mucus tissue model in which the simulated mucus-covered organ model is installed or integrally contained.

In one embodiment, the simulated mucus-covered organ model may include, in addition to simulated blood vessels, a structure for reproducing the morphology, movement, function, etc. of the organ in a living body.

[Medical Hand Skills Training] In this implementation method, "medical hand skills training" is as described in the first implementation method.

==The third implementation method (medical hand skills training method using a simulated mucus-coated mucosal tissue model)== The medical hand skills training method of this implementation method is the medical hand skills training method using the simulated mucus-coated mucosal tissue model of the first implementation method.

As described in the first embodiment, the mucosal tissue model is not limited by the animal species. The medical manual skill training method of this embodiment can also be a medical manual skill training method for humans, and can also be a medical manual skill training method for other animal species.

In this embodiment, the simulated mucus-coated mucosal tissue model is used as a simulated mucus-coated tissue sheet model. The simulated mucus-coated mucosal tissue model can be used alone for medical skill training, or it can be used for medical skill training when installed in various organ models with mucosal tissue in organisms such as digestive organs, urinary organs, reproductive organs, and respiratory organs.

[Medical Hand Skills Training] In this implementation method, "medical hand skills training" is as described in the first implementation method.

[Medical surgical technique training method] For example, in the treatment of mucosal tissue in a living body, in order to incise and/or stop bleeding of the mucosal tissue, the front end of the energy device is brought into contact with the mucosal tissue and energized. In the medical surgical technique training method of this embodiment, the front end of the energy device can be brought into contact with the surface (mucosal surface) of the simulated mucus-coated mucosal tissue model coated with a lubricating composition and energized, similar to the treatment in an actual living body.

More specifically, for example, a surgical electric scalpel (high-frequency surgical device manufactured by ERBE: VIO100C, conditions: monopolar, coagulation mode FORCED, 30 W, treatment tool: hemostatic forceps FD-410LR) can be brought into contact with the mucosal surface of a simulated mucus-coated mucosal tissue model coated with a 1 mm thick lubricating composition, which is a sheet material with a hydrogenated styrene-based thermoplastic elastomer as the main component as exemplified in the first embodiment, and energized.

Generally speaking, when electricity is applied to the mucous membrane tissue of a living body, the mucus covering the mucous membrane is heated and vaporized from the inside of the mucus, thereby starting to form bubbles, and the continuous generation of bubbles is gradually observed. In the medical skill training method using a model simulating mucous-covered mucous membrane tissue, the size of the bubbles, the number of bubbles generated, and other behaviors of the mucus that are the same as those actually observed when electricity is applied to the mucous membrane tissue that is the object of the trained medical skill can be used as a standard to judge whether the electricity is applied.

For example, in the treatment of a biological body using an energy device, the generation of five or more bubbles with a diameter of 0.2 mm or more for a certain period of time (e.g., 1 second) is sometimes used as a standard for completion of the electrification. In this case, in a simulated mucus-coated mucosal tissue model, the energy device can also be brought into contact with the simulated mucus-coated mucosal tissue model to energize, and the generation of five or more bubbles with a diameter of 0.2 mm or more in the lubricating composition of the simulated mucus for a certain period of time (e.g., 1 second) is used as a standard for completion of the electrification.

By making the volume resistivity of the lubricating composition in the range of 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )Ω·cm, and the viscosity of the lubricating composition at 25°C measured by the measurement method specified in JIS Z8803 in the range of 1.0E+00 to 1.0E+05 (1.0 to 1.0×10 ⁵ )mPa·s, the lubricating composition can easily reproduce the behavior of mucus in the treatment of mucosal tissue of a living body using energy equipment in the simulated mucus-coated mucosal tissue model of the present embodiment. Furthermore, when the lubricating composition is applied to simulate the situation where the surface of the mucosal surface is covered with the lubricating composition, the coating adaptability when applied to the mucosal tissue model is easily improved. Furthermore, the medical hand skill training method according to the present embodiment can reduce the risk of deformation or failure of energy equipment caused by the thermoplastic resin used in the previous medical hand skill training when it is energized and heated.

In one embodiment, when the simulated mucus-coated mucosal tissue model includes a simulated blood vessel connected to a device for supplying simulated blood, the medical skill training method may be a hemostasis training method assuming bleeding from the simulated blood vessel. In such a hemostasis training scenario, simulated blood may be supplied to the simulated blood vessel to reproduce bleeding in the mucosal tissue before using the energy device for medical skill training.

The medical skill training method according to the present embodiment can reproduce the behavior of the mucus of the mucosal tissue of a living body when the mucosal tissue is treated with an energy device, and thus can be used to enable medical personnel to master the skill of treating a living body.

==The fourth implementation method (medical hand skills training method using a simulated mucus-covered organ model)== The medical hand skills training method of this implementation method is the medical hand skills training method using the simulated mucus-covered organ model of the second implementation method.

As described in the second embodiment, the organ model is not limited by the animal species. The medical manual skill training method of this embodiment can also be a medical manual skill training method for humans, and can also be a medical manual skill training method for other animal species.

In this embodiment, "medical skill training" is as described in the first embodiment, and "medical skill training method" is as described in the third embodiment. In the medical skill training method of this embodiment, the medical skill training method described in the third embodiment can be performed on the mucosal tissue model installed or integrally included in the simulated mucus-covered organ model.

The medical skill training method according to the present embodiment can reproduce the behavior of the mucus of the mucosal tissue of a living body when the mucosal tissue is treated with an energy device, and thus can be used to enable medical personnel to master the skill of treating a living body.

==The fifth embodiment (method for manufacturing a mucosal tissue model)== The manufacturing method of this embodiment is a method for manufacturing a simulated mucus-coated mucosal tissue model for medical manual skill training, which includes the step of coating the surface of a simulated mucosal surface of a mucosal tissue model that simulates at least a portion of the mucosal tissue of a biological body with a lubricating composition, wherein the volume resistivity of the lubricating composition is 1.0E+00～1.0E+05(1.0～1.0×10 ⁵ )Ω·cm, and the viscosity at 25°C measured by the measurement method specified in JIS Z8803 is 1.0E+00～1.0E+05(1.0～1.0×10 ⁵ )mPa·s.

[Lubricating composition] In this embodiment, the lubricating composition is as described in the first embodiment under the item “Lubricating composition”.

[Mucosa tissue model] In this embodiment, the mucosa tissue model is as described in the "mucosa tissue model" of the first embodiment.

[Medical Hand Skills Training] In this implementation method, "medical hand skills training" is as described in the first implementation method.

[Manufacturing method] The manufacturing method of this embodiment includes the step of coating the surface of the mucosal surface of the simulated mucosal tissue of the mucosal tissue model that simulates at least a portion of the mucosal tissue of a biological body with a lubricating composition. The lubricating composition does not necessarily have to cover the entire surface of the mucosal surface of the simulated mucosal tissue, and can be coated in a manner that covers at least the portion that is contacted and energized by the front end of the energy device in medical skill training. As described in the first embodiment, in one embodiment, the mucosal tissue model may include a simulated blood vessel connected to a device that can supply simulated blood. When manufacturing a mucosal tissue model for use in hemostasis training assuming bleeding from a simulated blood vessel using such a mucosal tissue model including a simulated blood vessel connected to a device for supplying simulated blood, at least the periphery of the simulated blood vessel can be coated with a lubricating composition.

In one embodiment, the thickness of the lubricating composition in the step of coating the mucosal tissue model is preferably 0.01-3.0 mm, more preferably 0.01-2.5 mm, and further preferably 0.05-1.0 mm. In the case of 0.05-1.0 mm, it can be 0.1 mm, 0.5 mm, or 1.0 mm.

The lubricating composition can be applied to the mucosal surface of the simulated mucosal tissue using fingers or a spatula as appropriate.

The timing of coating the mucosal surface of the simulated mucosal tissue with the lubricating composition, preferably the timing of applying the lubricating composition, can be determined in a manner that can reproduce the state of mucus in the mucosal tissue of a living body when energized by an energy device during medical skill training.

The simulated mucus-coated mucosal tissue model manufactured by the manufacturing method of this embodiment can reproduce the behavior of mucus in the mucosal tissue of a living body when the mucosal tissue is treated with an energy device, and therefore can be used for medical skill training.

==The 6th embodiment (organ model manufacturing method)== The manufacturing method of this embodiment is a method for manufacturing a simulated mucus-coated organ model for medical manual skill training, which includes the step of coating the surface of the simulated mucosal surface of an organ model of a mucosal tissue model that simulates at least a portion of the mucosal tissue of a biological body with a lubricating composition, wherein the volume resistivity of the lubricating composition is 1.0E+00～1.0E+05(1.0～1.0×10 ⁵ )Ω·cm, and the viscosity at 25°C measured by the measurement method specified in JIS Z8803 is 1.0E+00～1.0E+05(1.0～1.0×10 ⁵ )mPa·s.

[Lubricating composition] In this embodiment, the lubricating composition is as described in the first embodiment under the item “Lubricating composition”.

[Organ model] In this embodiment, the organ model including a mucosal tissue model simulating at least a portion of the mucosal tissue of a living body is as described in the second embodiment.

In this embodiment, "medical skill training" is as described in the first embodiment.

[Manufacturing method] The manufacturing method of this embodiment includes the step of coating the surface of the simulated mucosal surface of the organ model with a lubricating composition, wherein the organ model includes a mucosal tissue model that simulates at least a portion of the mucosal tissue of a biological body.

The step of coating the mucosal surface of the simulated mucosal tissue of the mucosal tissue model with the lubricating composition can be performed as described in the fifth embodiment.

As described in the second embodiment, the organ model can be formed by integrally forming a mucosal tissue model and an organ model equipped therewith, or the mucosal tissue model and the organ model can be formed separately, and the mucosal tissue model can be mounted on the organ model by the method described in the first embodiment before medical skill training. In the case where the mucosal tissue model and the organ model are integrally formed, a part of the mucosal tissue model can be coated with a lubricating composition after forming to complete the simulated mucus-coated organ model. When the mucosal tissue model and the organ model are formed separately, the lubricating composition can be applied to the mucosal tissue model before being installed on the organ model to complete the simulated mucus-covered organ model, or the mucosal tissue model can be covered with the lubricating composition after being installed on the organ model to complete the simulated mucus-covered organ model.

The simulated mucus-coated mucosal tissue model manufactured by the manufacturing method of this embodiment can reproduce the behavior of mucus in the mucosal tissue of a living body when the mucosal tissue is treated with an energy device, and therefore can be used for medical skill training.

==The 7th embodiment (kit including a mucosal tissue model)== The kit of this embodiment is a kit for medical manual skill training, which includes a lubricating composition and a mucosal tissue model. The volume resistivity of the lubricating composition is 1.0E+00～1.0E+05 (1.0～1.0×10 ⁵ )Ω·cm, and the viscosity at 25°C measured by the measurement method specified in JIS Z8803 is 1.0E+00～1.0E+05 (1.0～1.0×10 ⁵ )mPa·s. The mucosal tissue model simulates at least a part of the mucosal tissue of a biological body.

[Lubricating composition] In this embodiment, the lubricating composition is as described in the first embodiment under the item “Lubricating composition”.

[Mucosal tissue model] In this embodiment, the mucosal tissue model that simulates at least a portion of the mucosal tissue of a living body is as described in the "mucosal tissue model" of the first embodiment.

[Kit] In addition to the lubricating composition and mucosal tissue model, the kit of this embodiment may also include one or more devices required for medical skill training, medical equipment, consumables for medical treatment, etc. The kit of this embodiment may include, for example, a microscope used in medical treatment, energy equipment, a recording camera, a computer, forceps, clamps, cotton wool for hemostasis, sponges, and an aqueous solution to simulate blood, etc. Before using the kit of this embodiment for medical skill training, the user can complete the simulated mucus-coated mucosal tissue model by coating the mucosal surface of the simulated mucosal tissue of the mucosal tissue model with a lubricating composition. The completed simulated mucus-coated mucosal tissue model can be used for the medical skill training described in the third embodiment.

The step of coating the mucosal surface of the simulated mucosal tissue of the mucosal tissue model with the lubricating composition can be performed as described in the fifth embodiment.

“Medical manual skills training” is as described in the first implementation method.

==Eighth embodiment (kit including organ model)== The kit of this embodiment is a kit for medical manual skill training, which includes a lubricating composition and an organ model. The volume resistivity of the lubricating composition is 1.0E+00～1.0E+05 (1.0～1.0×10 ⁵ )Ω·cm, and the viscosity at 25°C measured by the measurement method specified in JIS Z8803 is 1.0E+00～1.0E+05 (1.0～1.0×10 ⁵ )mPa·s. The organ model includes a mucosal tissue model that simulates at least a part of the mucosal tissue of a biological body.

[Lubricating composition] In this embodiment, the lubricating composition is as described in the first embodiment under the item “Lubricating composition”.

[Organ model] In this embodiment, the organ model is as described in the second embodiment. In one embodiment, the organ model may include a simulated blood vessel connected to a device that can supply simulated blood.

[Kit] In addition to the lubricating composition and the organ model, the kit of this embodiment may also include one or more devices, medical equipment, medical treatment consumables, etc. required for medical skill training. For example, it may include a microscope, energy equipment, recording camera, computer, forceps, clamps, hemostatic cotton, sponge, and aqueous solution to simulate blood, etc. used in medical treatment. Before using the kit of this embodiment for medical skill training, the user can complete the simulated mucus-covered organ model by coating the surface of the mucosal surface of the simulated mucosal tissue of the organ model with the lubricating composition. The completed simulated mucus-covered organ model can be used for the medical skill training described in the fourth embodiment.

Here, the step of coating the mucosal surface of the simulated mucosal tissue of the mucosal tissue model with the lubricating composition can be performed as described in the fifth embodiment.

“Medical manual skills training” is as described in the first implementation method.

==9th Implementation Method (Device)== The device of this implementation method is a medical manual skill training device, which has a simulated mucus-covered organ model of the second implementation method and an organ model simulating one or more other types of organs.

Here, the device of the present embodiment may include a plurality of simulated mucus-covered organ models. Other types of organs are not limited, as long as they are different from the organs of the simulated mucus-covered organ models. For example, the device may be a device in which a series of digestive organs such as the oral cavity, pharynx, esophagus, stomach, duodenum, small intestine, large intestine, rectum, and anus are connected in a manner that reproduces a biological body. In addition, the device may also be a device that includes one or more simulated mucus-covered organ models as part of a human model or animal model that has various organs regardless of the presence or absence of mucosal tissue.

The device of this embodiment can be used for medical hand skills training. "Medical hand skills training" is as described in the first embodiment.

==10th embodiment (lubricating composition for covering mucosal tissue model)== The lubricating composition of this embodiment is a lubricating composition for covering a mucosal tissue model, and its volume resistivity is 1.0E+00～1.0E+05(1.0～1.0×10 ⁵ )Ω·cm, and its viscosity at 25°C measured by the measurement method specified in JIS Z8803 is 1.0E+00～1.0E+05(1.0～1.0×10 ⁵ )mPa·s. Its purpose is to cover the surface of the mucosal surface simulating mucosal tissue in a mucosal tissue model.

[Lubricating composition] In this embodiment, the lubricating composition is as described in the first embodiment under the item “Lubricating composition”.

[Mucosal tissue model] In this embodiment, the mucosal tissue model is as described in the "mucosal tissue model" of the first embodiment.

The lubricating composition of the present embodiment is a lubricating composition for coating a mucosal tissue model. By coating a mucosal tissue model with the lubricating composition, a simulated mucus-coated mucosal tissue model is manufactured. By making the volume resistivity of the lubricating composition 1.0E+00～1.0E+05(1.0～1.0×10 ⁵ )Ω·cm, and the viscosity at 25°C measured by the measurement method specified in JIS Z8803 to be 1.0E+00～1.0E+05(1.0～1.0×10 ⁵ )mPa·s, the lubricating composition can easily reproduce the behavior of mucus in the treatment of the mucosal tissue of a living body using energy equipment in the simulated mucus-coated mucosal tissue model. In addition, when coating is performed by coating, the coating compatibility of the lubricating composition when applied to the mucosal tissue model is easily improved. Furthermore, the lubricating composition according to the present embodiment can reduce the risk of deformation or failure of energy devices caused by electricity and heating of thermoplastic resins used in previous medical manual training. Therefore, the simulated mucus-coated mucosal tissue model of the present embodiment can be preferably used for medical manual training.

In one embodiment, the thickness of the lubricating composition coating the mucosal tissue model is preferably 0.01 to 3.0 mm, more preferably 0.05 to 2.5 mm, and further preferably 0.05 to 1.0 mm. In the case of 0.05 to 1.0 mm, it can be 0.1 mm, 0.5 mm, or 1.0 mm. By making the thickness of the lubricating composition coating the simulated mucus-coated mucosal tissue model in the range of 0.01 to 3.0 mm, the lubricating composition can easily reproduce the behavior of mucus in the treatment of the mucosal tissue of a living body using an energy device in the simulated mucus-coated mucosal tissue model.

“Medical manual skills training” is as described in the first implementation method.

The coating of the mucosal surface of the simulated mucosal tissue of the mucosal tissue model with the lubricating composition can be carried out as described in the fifth embodiment.

==The 11th embodiment (purpose)== The purpose of this embodiment is to use the lubricating composition to cover the surface of the mucosal surface simulating the mucosal tissue in the mucosal tissue model (preferably to be applied to the surface), the volume resistivity of the lubricating composition is 1.0E+00～1.0E+05(1.0～1.0×10 ⁵ )Ω·cm, and the viscosity at 25°C measured by the measurement method specified in JIS Z8803 is 1.0E+00～1.0E+05(1.0～1.0×10 ⁵ )mPa·s.

According to the use of the present embodiment, a simulated mucus-coated mucosal tissue model is manufactured by coating a mucosal tissue model with a lubricating composition. By making the volume resistivity of the lubricating composition 1.0E+00-1.0E+05 (1.0-1.0×10 ⁵ )Ω·cm and the viscosity at 25°C measured by the measurement method specified in JIS Z8803 1.0E+00-1.0E+05 (1.0-1.0×10 ⁵ )mPa·s, the lubricating composition can easily reproduce the behavior of mucus in the treatment of the mucosal tissue of a living body using an energy device in the simulated mucus-coated mucosal tissue model. In addition, when the coating is performed by coating, the coating adaptability of the lubricating composition when applied to the mucosal tissue model is easily improved. Furthermore, according to the use of the lubricating composition of the present embodiment, the risk of deformation or failure of energy equipment caused by the thermoplastic resin used in the previous medical manual skill training due to electricity and heating can be reduced. Therefore, according to the use of the lubricating composition of the present embodiment, the simulated mucus-coated mucosal tissue model coated with the lubricating composition can be preferably used for medical manual skill training.

“Medical manual skills training” is as described in the first implementation method.

[Lubricating composition] In this embodiment, the lubricating composition is as described in the first embodiment under the item “Lubricating composition”.

[Mucosa tissue model] In this embodiment, the mucosa tissue model is as described in the first embodiment under the heading "mucosa tissue model".

Hereinafter, the present invention will be described in more detail with reference to embodiments, but the interpretation of the present invention is not limited to these embodiments.

The various raw materials and manufacturing methods used in the embodiments are as follows.

[Mucosal tissue model] The sample sheet described below was used as a mucosal tissue model for evaluating the lubricating composition. (A) Hydrogenated styrene-based thermoplastic elastomer · Hydrogenated styrene-based thermoplastic elastomer: SEEPS (SEPTON 4055, manufactured by Kuraray Co., Ltd.) (MFR (temperature 230°C, load 2.16 kg) is 0.0 g/10 minutes (0.0 g/10 minutes means no flow), styrene content is 30% by mass, hydrogenation rate is 90 mol% or more) (B) Oil · Paraffin oil (Diana Process Oil PW90, manufactured by Idemitsu Kosan Co., Ltd.) (C) Copolymer of hydrophobic polymer and hydrophilic polymer · C-1: Polyolefin/polyether copolymer (PELECTRON PVL, manufactured by Sanyo Chemical Industries, Ltd.) (MFR (measured at 190°C, load 2.16 kg) is 8 to 15 g/10 minutes) ·C-2: Polyethylene glycol/polypropylene glycol copolymer (Pluronic (registered trademark) L-34, manufactured by ADEKA) (average molecular weight 1700, ethylene oxide ratio 40%, viscosity at 25°C 300 mPa·s) (D) Ionic liquid ·CIL-312 (manufactured by Japan Carlit)

400 parts by mass of oil, 30 parts by mass of copolymer of hydrophobic polymer and hydrophilic polymer, and 100 parts by mass of ionic liquid were added to 100 parts by mass of hydrogenated styrene-based thermoplastic elastomer and stored for more than 12 hours to allow them to fully penetrate. Kneading was performed at 180°C and 100 rpm for 15 minutes using a segmented mixer (Labo Plastomill KF70 V2 manufactured by Toyo Seiki Co., Ltd.). Next, a sample sheet with a width of 100 mm, a length of 100 mm, and a thickness of 2 mm was prepared by a hot pressing method (180°C, a time of 5 minutes, and a pressure of 50 kg/cm ² ).

[Lubricating composition] (Example) The following compositions were used for evaluation. (1) Sodium chloride aqueous solution (1.7E+00 (1.7) M): 100 g of sodium chloride was added to 900 g of distilled water and stirred. (2) Sodium chloride aqueous solution (8.6E-06 (8.6×10 ^-6 ) M): 0.0005 g of sodium chloride was added to 999.9995 g of distilled water and stirred. (3) Sodium polyacrylate aqueous solution (10 wt%): 990 g of distilled water was added to 10 g of ARON A-20L manufactured by Toagosei Co., Ltd. and stirred. (4) Sodium polyacrylate aqueous solution (100 wt%): ARON A-20L manufactured by Toagosei Co., Ltd. was used directly without dilution. (5) Sodium polyacrylate aqueous solution: Heat 100 g of ARON A-20L manufactured by Toagosei Co., Ltd. at 80°C for 30 minutes and concentrate until 100 g becomes 88 g. (6) Lubricating gel: Sterile lubricating gel (Boston Scientific, catalog number SLT-612-10) (7) Echo gel: ECHO JELLY MORE (registered trademark) (gel for ultrasound examination) (manufactured by FUJIFILM Healthcare Co., Ltd.)

(Comparative Example) (8) Distilled water (9) Polyethylene glycol: Polyethylene glycol 400 (manufactured by Fuji Film Wako Pure Chemical Industries, Ltd., product number 69268-9001) (10) Glycerin: Glycerin for cosmetics (manufactured by Kenei Pharmaceutical Co., Ltd., product number 2E15) (11) Sodium chloride aqueous solution (8.6E-08 (8.6×10 ^-8 )M): Sodium chloride 5.0E-06 (5.0×10 ^-6 ) g is added to 1000 g of distilled water and stirred. (12) Sodium polyacrylate aqueous solution: 100 g of ARON A-20L manufactured by Toagosei Co., Ltd. is heated at 100°C for 20 minutes and concentrated to 53 g per 100 g.

[Measurement] (Volume resistivity) Volume resistivity is calculated by AC impedance measurement at a measurement temperature of 25°C. The measurement is carried out under the conditions of DC (Direct Current) voltage of 0 V, AC (Alternating Current) waveform amplitude of 10 mV, and frequency of 1.0E+00～1.0E+05 (1.0～1.0×10 ⁵ )Hz. Specifically, the measurement sample is placed in a liquid measurement tank with a diameter of 13 mm and a thickness of 5 mm, and the metal terminals at both ends of the tank in contact with the measurement sample are connected to the terminals of the AC impedance measurement device (Solartron SI 1287, frequency response analyzer 1252A manufactured by Dongyang Technology Co., Ltd.). The resistivity of the cell was measured at 25°C using a small environmental tester (manufactured by ESPEC Co., Ltd., model number: SU-241). The result was divided by the thickness of 5 mm to calculate the volume resistivity.

(Viscosity) The viscosity is measured by the measurement method specified in JIS Z8803, using a rheometer (MCR-92 manufactured by Anton Paar) with a 50 mm diameter cone, a measurement temperature of 25°C, and a shear rate of 10/s.

[Evaluation method] The lubricating compositions (1) to (12) were applied to the sample sheet with a thickness of 1 mm, and a surgical electric knife (high-frequency surgical device manufactured by ERBE: VIO100C, conditions: monopolar, coagulation mode FORCED, 30 W, treatment tool: hemostatic forceps FD-410LR) was placed on the sample sheet and powered on to observe the formation of bubbles.

(1) Indicator: Mucus bubble generation in biological mucosal tissue For mucus collected from human adult gastric mucosal tissue, the volume resistivity and viscosity were measured as described in the above [Measurement]. The volume resistivity was 4.0E+01 (4.0×10 ¹ ) Ω·cm, and the viscosity was 2.0E+2 (2.0×10 ² ) mPa·s. Furthermore, in the above gastric mucosal tissue, treatment was performed by energizing a surgical electric scalpel (high-frequency surgical device manufactured by ERBE: VIO100C, conditions: monopolar, coagulation mode FORCED, 30 W, treatment tool: hemostatic forceps FD-410LR). When the energization was completed, 14 bubbles larger than 0.2 mm were generated for 1 second. During the treatment in the living body, since water flows out from the front end of the endoscope to clean the body fluids and other dirt attached to the lens of the endoscope, the volume resistivity, viscosity, and number of bubbles are affected by water. Taking this into consideration, in (2) below, the "reproduction of continuous bubble generation in the living body" is judged to be carried out by the generation of more than 5 bubbles for 1 second.

(2) Number of bubbles and recurrence of continuous bubble generation The number of bubbles larger than 0.2 mm per second after the bubbles started to be generated continuously during power-on was measured as the number of bubbles. Regarding "recurrence of continuous bubble generation", when 5 to 15 bubbles were generated for 1 second, it was judged as "good", and when 16 or more bubbles were generated for 1 second, it was judged as "excellent". When there were 4 or less bubbles, it was recorded as "poor". Regarding the recurrence of continuous bubble generation, the lubricating compositions (1), (3), (4), (6), and (7) of the embodiment were "excellent", (2) and (5) were "good", and the lubricating compositions (8) to (12) of the comparative example were "poor".

(3) Application suitability When the lubricating compositions (1) to (12) were applied to the sample sheet with fingers, the case where there was a 5 mm or more string due to excessive stickiness (sticky feeling) was recorded as "poor application suitability" (excessive stickiness). The case where there was no excessive stickiness and the sample could be applied to a thickness of 1 mm was recorded as "good". The case where there was no excessive stickiness, the sample could be applied to a thickness of 1 mm, and even after 10 seconds after application, more than 90% of the initial application surface was covered with the lubricating composition was recorded as "excellent". Regarding coating compatibility, lubricating compositions (4) to (7) of the embodiments were rated "excellent", (1) to (3) were rated "good", and lubricating compositions (8) to (11) of the comparative examples were rated "good", and (12) was rated "poor".

The results are shown in Table 1. [Table 1] Embodiment Comparison Example 1 2 3 4 5 6 7 8 9 10 11 12 Lubricating composition Sodium chloride aqueous solution ○ ○ ○ Sodium polyacrylate aqueous solution ○ ○ ○ ○ Lubricating Gel ○ Echo Gel ○ Distilled water ○ Polyethylene glycol ○ glycerin ○ Evaluation Results Volume resistivity (Ω·cm) 8.2E+ 00 8.0E+04 1.3E+02 1.9E+01 1.2E+01 9.6E+02 6.4E+02 8.4E+05 8.6E+05 1.6E+07 2.0E+05 1.0E+01 Viscosity (mPa·s) 1.1E+ 00 1.1E+00 1.1E+02 2.6E+04 8.0E+04 9.0E+03 1.4E+04 1.1E+00 8.4E+01 7.9E+01 1.1E+00 2.0E+05 Recurrence of continuous bubble generation Excellent good Excellent Excellent good Excellent Excellent bad bad bad bad bad Number of bubbles 34 12 15 20 5 18 15 1 1 2 2 1 Coating adaptability good good good Excellent Excellent Excellent Excellent good good good good bad [Industrial Availability]

According to the present implementation, a simulated mucus-coated mucosal tissue model and an organ model, a medical skill training method using the model, a method for manufacturing the model, a kit and a device comprising the model, and a lubricating composition for covering the mucosal tissue model can be provided. The simulated mucus-coated mucosal tissue model and the organ model have industrial applicability. The simulated mucus-coated mucosal tissue model and the organ model can reproduce the behavior of mucus during the treatment of the mucosal tissue of a biological body using an energy device, and/or can reduce the risk of deformation or failure of the energy device during medical skill training.

Claims (26)

A simulated mucus-coated mucosal tissue model for medical manual skill training, wherein the mucosal surface of the simulated mucosal tissue of at least a portion of the mucosal tissue of the mucosal tissue model simulating a biological body is coated with a lubricating composition, the volume resistivity of the lubricating composition is 1.0 to 1.0×10 ⁵ Ω·cm, and the viscosity at 25°C measured by the measurement method specified in JIS Z8803 is 1.0 to 1.0×10 ⁵ mPa·s. A simulated mucus-coated mucosal tissue model as claimed in claim 1, comprising a simulated blood vessel connected to a device for supplying simulated blood. A simulated mucus-coated mucosal tissue model as claimed in claim 1 or 2, wherein the medical technique includes incision or hemostasis of the mucosal tissue using an energy device. A simulated mucus-covered organ model for medical manual skill training comprises a simulated mucus-covered mucosal tissue model as claimed in claim 1. A simulated mucus-covered organ model as claimed in claim 4, comprising a simulated blood vessel connected to a device for supplying simulated blood. A simulated mucus-covered organ model as claimed in claim 4 or 5, wherein the medical technique includes incision or hemostasis of mucosal tissue using an energy device. A medical manual skill training method uses the simulated mucus-coated mucosal tissue model of claim 1. A medical manual skill training method using the simulated mucus-covered organ model of claim 4. A method for training medical techniques as claimed in claim 7 or 8, wherein the medical techniques include incision or hemostasis of mucosal tissue using an energy device. A method for manufacturing a simulated mucus-coated mucosal tissue model for medical manual skill training comprises the step of coating the simulated mucosal surface of at least a portion of the mucosal tissue model simulating the mucosal tissue of a biological body with a lubricating composition, wherein the lubricating composition has a volume resistivity of 1.0 to 1.0×10 ⁵ Ω·cm and a viscosity of 1.0 to 1.0×10 ⁵ mPa·s at 25°C measured by the measurement method specified in JIS Z8803. A manufacturing method as claimed in claim 10, wherein the mucosal tissue model comprises a simulated blood vessel connected to a device for supplying simulated blood. A method of manufacture as claimed in claim 10 or 11, wherein the medical procedure comprises incision or hemostatic treatment of mucosal tissue using an energy device. A method for manufacturing a simulated mucus-coated organ model for medical manual skill training comprises the step of coating the mucosal surface of the simulated mucosal tissue of an organ model including a mucosal tissue model simulating at least a part of the mucosal tissue of a biological body with a lubricating composition, wherein the lubricating composition has a volume resistivity of 1.0 to 1.0×10 ⁵ Ω·cm and a viscosity of 1.0 to 1.0×10 ⁵ mPa·s at 25°C measured by the measurement method specified in JIS Z8803. A manufacturing method as claimed in claim 13, wherein the simulated mucus-coated organ model includes a simulated blood vessel connected to a device for supplying simulated blood. A method of manufacture as claimed in claim 13 or 14, wherein the medical procedure comprises incision or hemostatic treatment of mucosal tissue using an energy device. A medical manual skill training kit comprises a lubricating composition and a mucosal tissue model. The lubricating composition has a volume resistivity of 1.0 to 1.0×10 ⁵ Ω·cm and a viscosity of 1.0 to 1.0×10 ⁵ mPa·s at 25°C measured by the measurement method specified in JIS Z8803. The mucosal tissue model simulates at least a part of the mucosal tissue of a living body. A medical skill training kit as claimed in claim 16, wherein the mucosal tissue model includes a simulated blood vessel connected to a device for supplying simulated blood. A medical manual skill training kit as claimed in claim 16 or 17, wherein the medical manual skill comprises incision or hemostasis of mucosal tissue using an energy device. A medical manual skill training kit comprises a lubricating composition and an organ model. The lubricating composition has a volume resistivity of 1.0 to 1.0×10 ⁵ Ω·cm and a viscosity of 1.0 to 1.0×10 ⁵ mPa·s at 25°C measured by the measurement method specified in JIS Z8803. The organ model comprises a mucosal tissue model that simulates at least a portion of the mucosal tissue of a biological body. A medical skill training kit as claimed in claim 19, wherein the organ model includes a simulated blood vessel connected to a device for supplying simulated blood. A medical manual skill training kit as claimed in claim 19 or 20, wherein the medical manual skill comprises incision or hemostasis of mucosal tissue using an energy device. A medical manual skill training device comprises a simulated mucus-covered organ model as claimed in claim 4 or 5, and an organ model simulating one or more other types of organs. A lubricating composition for coating a mucosal tissue model has a volume resistivity of 1.0 to 1.0×10 ⁵ Ω·cm and a viscosity of 1.0 to 1.0×10 ⁵ mPa·s at 25°C measured by the measurement method specified in JIS Z8803. The composition is used for coating the surface of a mucosal surface simulating mucosal tissue in a mucosal tissue model. A mucosal tissue model as claimed in claim 23 is coated with a lubricating composition, wherein the mucosal tissue model comprises a simulated blood vessel connected to a device for supplying simulated blood. The mucosal tissue model of claim 23 or 24 is coated with a lubricating composition, which is used to reproduce the behavior of mucus during treatment of the mucosal tissue of a living body using an energy device in the mucosal tissue model. A mucosal tissue model as claimed in claim 25 is coated with a lubricating composition, wherein the treatment of the mucosal tissue of a living body using an energy device includes incision or hemostasis of the mucosal tissue.