Tissue model or organ model, biological model, method for manufacturing tissue model or organ model, method for generating data set, and trained model

Abstract

A tissue model or organ model according to an embodiment of the present invention comprises a composite including a plurality of components fused to each other, wherein the plurality of components each include a thermoplastic elastomer and an oil, and the plurality of components have colors different from each other.

Description

Tissue or organ model, biological model, method for manufacturing tissue or organ model, data set generation method, and trained model

[0001]

[0001] Embodiments of the present invention relate to a tissue or organ model, a biological model, a method for manufacturing a tissue or organ model, a method for generating a dataset, and a trained model. This application claims priority to Japanese Patent Application No. 2024-149933, filed in Japan on August 30, 2024, the contents of which are incorporated herein by reference.

[0002] Mimic tissues or organs for the training of doctors are known (US Pat. No. 5,623,999).

[0003] Japan Special Table No. 2019-522243

[0004] The inventors came up with the idea of ​​using images (still images or videos) of simulated surgery on a biological model as training data for a surgical robot. Currently, most commercially available biological models are simple and designed for surgeons to train surgical procedures, and lack realism. However, for a surgical robot that performs surgical operations according to the situation through image recognition, it is desirable for the training image data to be as close as possible to actual surgical images. Therefore, the inventors completed the present invention with the aim of providing technology that can improve the realism of biological models.

[0005] The problem to be solved by one aspect of the present invention is to provide a tissue model or organ model with improved realism and a method for manufacturing a tissue model or organ model, but the problem to be solved by the present invention is not limited thereto and may be any problem that can be recognized by a person skilled in the art from the contents of this specification.

[0006] In order to solve the above problems, the inventors came up with the idea that the color tone of biological tissue could be more accurately reproduced by using multiple parts of different colors. After extensive research, the inventors discovered that the reproducibility of biological tissue could be improved by constructing multiple parts of different colors using thermoplastic elastomer and oil and fusing them together by heating.

[0007] The present invention may include the following aspects. [1] A tissue model or organ model comprising a composite including a plurality of parts fused to one another, wherein the plurality of parts each contain a thermoplastic elastomer and an oil and have different colors. [2] The tissue model or organ model according to [1], wherein the plurality of parts form an irregular color pattern by being fused to one another. [3] The tissue model or organ model according to [1] or [2], wherein an irregular color pattern is formed on at least the surface of the composite. [4] The tissue model or organ model according to any one of [1] to [3], wherein an irregular color pattern is formed at least inside the composite. [5] The tissue model or organ model according to any one of [1] to [4], wherein the plurality of parts are three-dimensionally mixed and integrated. [6] The tissue model or organ model according to any one of [1] to [5], wherein the composite as a whole mimics a single type of tissue. [7] The tissue model or organ model according to any one of [1] to [6], wherein the composite mimics adipose tissue. [8] The tissue model or organ model according to any one of [1] to [7], wherein the plurality of parts contain the thermoplastic elastomer and the oil in mutually different mass ratios. [9] The tissue model or organ model according to any one of [1] to [8], wherein each of the plurality of parts contains 100 to 1,500 parts by mass of the oil, based on 100 parts by mass of the thermoplastic elastomer.

[10] The tissue model or organ model according to any one of [1] to [9], wherein the thermoplastic elastomer comprises one or more selected from the group consisting of a styrene-based thermoplastic elastomer, an olefin-based thermoplastic elastomer, a urethane-based thermoplastic elastomer, an ester-based thermoplastic elastomer, an acrylic-based thermoplastic elastomer, and an amide-based thermoplastic elastomer.

[11] The tissue model or organ model according to any one of [1] to

[10] , wherein the oil comprises one or more selected from the group consisting of a paraffin-based oil, a naphthenic oil, a synthetic hydrocarbon oil, an ester oil, an ether oil, a silicone oil, a fluorine-based oil, a vegetable oil, and an animal oil.

[12] The tissue model or organ model according to any one of [1] to

[11] , further comprising a tendon tissue model or a connective tissue model that mimics tendon tissue, wherein the tendon tissue model or the connective tissue model contains a fibrous material.

[13] The tissue model or organ model according to

[12] , wherein the tendon tissue model or the connective tissue model is fused to the composite.

[14] The tissue model or organ model according to any one of [1] to

[13] , further comprising a calcified tissue model that mimics calcified tissue, wherein the calcified tissue model contains hard particles.

[15] The tissue model or organ model according to

[14] , wherein the calcified tissue model is fused to the composite.

[16] A biological model comprising the tissue model or organ model according to any one of [1] to

[15] .

[17] A method for manufacturing a tissue model or an organ model, comprising: a first material preparation step of preparing a first material containing a thermoplastic elastomer and an oil and having a first color; a second material preparation step of preparing a second material containing a thermoplastic elastomer and an oil and having a second color different from the first color; and a fusion step of fusing at least the first material and the second material while heating.

[18] The method according to

[17] , wherein at least one of the first material preparation step and the second material preparation step includes mixing the thermoplastic elastomer and the oil while heating, and then cooling.

[19] The method according to

[18] , wherein the heating temperature when mixing the thermoplastic elastomer and the oil while heating is 100°C or higher and 250°C or lower.

[20] The method according to any one of

[17] to

[19] , wherein the fusion step includes non-uniformly mixing the first material and the second material.

[21] The method according to any one of

[17] to

[20] , wherein the heating temperature in the fusion step is 100°C or higher and 250°C or lower.

[21] A method for generating a dataset, comprising the steps of: acquiring images of a simulated surgery using the tissue model or organ model described in any one of [1] to

[15] and surgical information related to the simulated surgery that is associated with the images; and generating a dataset for surgical training that associates the images with the surgical information.

[22] A program for generating a dataset, which, when executed by a computer processor, causes the processor to execute the steps of: acquiring images of a simulated surgery using the tissue model or organ model described in any one of [1] to

[15] and surgical information related to the simulated surgery that is associated with the images; and generating a dataset for surgical training that associates the images with the surgical information.

[23] An information processing device comprising: a processor, wherein the processor acquires images of a simulated surgery using a tissue model or organ model described in any one of [1] to

[15] and surgical information related to the simulated surgery that is associated with the images, and generates a data set for surgical training that associates the images with the surgical information.

[24] An information processing device comprising: a processor and a memory, wherein the memory stores images of a simulated surgery using a tissue model or organ model described in any one of [1] to

[15] and surgical information related to the simulated surgery in association with each other, and the processor generates a data set for surgical training that associates the images with the surgical information.

[25] A trained model for surgery or surgical assistance, trained using images of a simulated surgery using the tissue model or organ model described in any one of [1] to

[15] and surgical information related to the simulated surgery associated with the images, the trained model, when executed by a computer processor, causing the processor to control the computer or a surgical instrument connected to the computer to perform the following steps (a) or (b): (a) causing the surgical instrument to perform the surgery autonomously or in collaboration with other instruments or a human; (b) causing the computer or the surgical instrument to assist in performing the surgery.

[26] The trained model described in

[25] , wherein in step (b), the assistance includes one or more selected from the group consisting of analysis of video images during surgery, adjustment of lighting position during surgery, automatic adjustment of the surgical field during surgery, presentation of surgical sites from similar previous surgeries during surgery, preoperative surgical simulation, and postoperative course prediction.

[27] The trained model described in

[25] or

[26] , which accepts input of an image of the surgical site and outputs one or more selected from the group consisting of the condition of the surgical site, an appropriate surgical method, the details of the surgery, the surgical route, the necessary instruments and equipment used, the surgical area, and an estimate of the surgical outcome.

[28] A method for generating a trained model, wherein the trained model is the trained model described in any one of

[25] to

[27] , and the generation method includes the steps of: training a machine learning model using images of a mock surgery using the tissue model or organ model described in any one of [1] to

[15] and surgical information related to the mock surgery; or training a machine learning model using a dataset generated by the method described in

[21] .

[29] The method described in

[28] , wherein the images include one or more of preoperative, intraoperative, and postoperative images, and the surgical information includes information related to the details or method of the surgery and information related to the outcome of the surgery.

[0008] According to one aspect of the present invention, it is possible to provide a tissue model or organ model with improved realism, and a method for manufacturing a tissue model or organ model.

[0009] 1 is a diagram showing the hardware configuration of an information processing device.

[0010] The following describes a tissue model or organ model, a biological model, a method for manufacturing a tissue model or organ model, a method for generating a dataset, and a trained model according to embodiments. Note that the following embodiment illustrates one aspect of the present invention and does not limit the present invention, and can be modified as desired within the scope of the technical concept of the present invention. Furthermore, each configuration and each feature of the embodiment can be combined as desired.

[0011] The inventors have discovered that by constructing multiple parts of different colors out of thermoplastic elastomer and oil and fusing them together by heating, it is possible to produce models of various tissues or organs with improved realism (e.g., appearance or texture). Note that, as used herein, "appearance" refers not only to the appearance of the tissue or organ, but also to the appearance of the internal structure exposed when the tissue or organ is cut.

[0012] In the following, first, the basic features of the tissue model or organ model and the method for manufacturing the same according to the embodiment will be described, and then specific tissues or organs will be individually described.

[0013] 1. Tissue or Organ Model The tissue or organ model according to this embodiment comprises a composite including multiple parts fused together, each of which contains a thermoplastic elastomer and oil and has a different color from the others. As used herein, "fused" means that different materials are mixed and bonded at the interface between them. "Different colors" means that the colors are different enough to be distinguishable by the normal human eye.

[0014] <1-1. Materials> To reproduce the texture of biological tissue or organs, the components constituting the tissue model or organ model may be manufactured by mixing thermoplastic elastomer and oil. Furthermore, to reproduce the appearance of biological tissue or organs, each component may have a different color. Preferably, each component is colored by adding a colorant. In this specification, "coloring" refers to reducing the average transmittance of the object in the visible light range (380 nm to 780 nm), and may include adding a material that absorbs or reflects light, and adding a material that scatters light. Each material will be described below.

[0015] <1-1-1. Thermoplastic elastomer> Thermoplastic elastomers function as the base material for the components of tissue or organ models. Because the base material has thermoplastic properties, the components can be fused together by heat treatment. This allows for excellent manufacturing efficiency of tissue or organ models. Furthermore, tissue or organ models used for surgical training can be reused for surgical training by heating and remolding them to their original shape.

[0016] The thermoplastic elastomer includes one or more selected from the group consisting of a styrene-based thermoplastic elastomer, an olefin-based thermoplastic elastomer, a urethane-based thermoplastic elastomer, an ester-based thermoplastic elastomer, an acrylic-based thermoplastic elastomer, and an amide-based thermoplastic elastomer.

[0017] Examples of styrene-based thermoplastic elastomers include styrene-ethylene-butylene block copolymer, styrene-ethylene-butylene-styrene block copolymer (SEBS), styrene-ethylene-propylene block copolymer, styrene-ethylene-propylene-styrene block copolymer (SEPS), styrene-ethylene-ethylene-propylene block copolymer, and styrene-(ethylene-ethylene-propylene)-styrene block copolymer (SEEPS).

[0018] Examples of olefin-based thermoplastic elastomers include polyolefin-based block copolymers having polyolefin blocks such as polyethylene and polypropylene as hard segments and rubber blocks such as ethylene-propylene rubber (EPM, EPDM) as soft segments.

[0019] Examples of urethane-based thermoplastic elastomers include polyurethane-based block copolymers having polyurethane blocks as hard segments and polyester blocks or polyether blocks as soft segments.

[0020] An example of the ester-based thermoplastic elastomer is a polyester-polyether block copolymer having an aromatic polyester block as a hard segment and an aliphatic polyether block as a soft segment.

[0021] Examples of acrylic thermoplastic elastomers include block copolymers having a plurality of polymer blocks each consisting of an alkyl methacrylate unit or an alkyl acrylate unit.

[0022] Examples of the amide-based thermoplastic elastomer include copolymers having polyamide blocks as hard segments and polyether blocks as soft segments.

[0023] <1-1-2. Oil> By adding oil to a thermoplastic elastomer, physical properties such as the elastic modulus and hardness of the part can be adjusted. This can improve the reproduction rate of the texture of biological tissue or organs. The type and amount of oil to be added can be determined appropriately depending on the type of tissue or organ of interest.

[0024] The oil includes one or more selected from the group consisting of paraffinic oil, naphthenic oil, synthetic hydrocarbon oil, ester oil, ether oil, silicone oil, fluorine oil, vegetable oil, and animal oil.

[0025] The oil content in the entire tissue model or organ model is, for example, 100 parts by mass or more and 1500 parts by mass or less, based on 100 parts by mass of the thermoplastic elastomer contained in the entire tissue model or organ model. If the oil content is 100 parts by mass or more, the tissue model or organ model will not become too hard and will be able to reproduce the texture of biological tissue to a minimum extent. If the oil content is 1500 parts by mass or less, the tissue model or organ model will be able to maintain its shape. Preferably, the oil content is 150 parts by mass or more and 1200 parts by mass or less, 200 parts by mass or more and 1100 parts by mass or less, 300 parts by mass or more and 1000 parts by mass or less, 500 parts by mass or more and 900 parts by mass or less, or 600 parts by mass or more and 800 parts by mass or less, based on 100 parts by mass of the thermoplastic elastomer.

[0026] However, the ratio of thermoplastic elastomer to oil may vary depending on the target tissue or organ. Furthermore, multiple components constituting the tissue or organ model may contain thermoplastic elastomer and oil at different mass ratios. This allows for variations in softness among the components, improving the reproducibility of texture.

[0027] <1-1-3. Colorant> The colorant is not particularly limited as long as it can color the target object, and any material such as pigment, dye, paint, particles, or fiber can be used. If the target part to be manufactured is colorless and transparent, the use of a colorant is unnecessary. However, even if the target part is colorless (white), if it is translucent or opaque, the target part can be colored by adding a light-scattering material, such as particles or fibers, as a colorant. If the thermoplastic elastomer or oil itself has a color, the use of a colorant is not necessary.

[0028] A transparent or translucent colorant is preferable because it improves the reproducibility of the appearance of biological tissue. However, in some cases, an opaque colorant may be preferable for reproducing specific biological tissues, such as coagulated tissue. To make a colorant transparent or translucent, it is preferable that the colorant material itself has high transparency in the visible light range, or that the particle size of the colorant particles is within a range that achieves high transparency in the visible light range. In this specification, "particle size" refers to the volume-cumulative particle size D50 at 50% of the cumulative volume measured using a laser diffraction particle size distribution analyzer.

[0029] The content of the colorant contained in the entire tissue model or organ model is, for example, 0.1 to 5 parts by mass, based on 100 parts by mass of the thermoplastic elastomer contained in the entire tissue model or organ model. If the content of the colorant is 0.1 parts by mass or more, it is possible to reproduce the color of biological tissue to a minimum extent. If the content of the colorant is 5 parts by mass or less, it is possible to prevent excessive use of colorant. Preferably, the content of the colorant is 0.2 to 2 parts by mass, or 0.5 to 1 part by mass, based on 100 parts by mass of the thermoplastic elastomer.

[0030] <1-2. Multiple Components and Composites> The tissue model or organ model according to this embodiment may have a composite formed of multiple components with different colors in order to reproduce the appearance of biological tissue or organs. The number of multiple components is not particularly limited, and for example, the composite may be composed of two, three, four, five or more components. By having multiple components with different colors, it is possible to reproduce the complex color variations and shading of biological tissue or organs.

[0031] The multiple parts are fused together, which allows us to mimic the bonds between biological tissues and organs. Furthermore, by fusing and partially blending parts of different colors, we can reproduce the natural colors of biological tissue. However, it is not necessary for the entire contact area between the parts to be fused together; some areas may simply be in physical contact.

[0032] A composite can take various forms depending on the shapes, sizes, arrangements, etc. of the multiple components. For example, a composite can take a form in which multiple components are entangled and fused together, a form in which multiple components are irregularly mixed together, or a form in which a first component among the multiple components is laminated on the surface of a second component. For example, multiple components may be mixed and integrated in a three-dimensional manner. Here, "mixed in a three-dimensional manner" means that the contact between the components is not a single-point contact or a planar contact, but a three-dimensional contact. Multiple components can be integrated by fusing them together. Examples include a case in which multiple components are entangled, or a case in which the fused interface between the components has a large uneven shape.

[0033] The composite as a whole can mimic one type of tissue. For example, the composite as a whole can mimic one type of tissue from among adipose tissue, brain tissue, muscle tissue, tendon tissue, connective tissue, and calcified tissue. However, the present invention is not limited to this, and the composite may mimic a composite of two or more types of tissue. Note that the tissue model or organ model may have two or more composites. In this case, the tissue model or organ model as a whole may be formed as a tissue model or organ model that mimics multiple types of tissue using multiple composites.

[0034] <1-3. Color Pattern> By mixing multiple components with different colors, the composite can exhibit a complex color pattern. For example, multiple components can form an irregular color pattern by fusing together. Alternatively, multiple components can form a mosaic pattern of different colors. Here, "mosaic pattern" refers to a pattern in which multiple colors are irregularly mixed. In this case, the composite can have a color pattern in which different colors are randomly mixed. This can improve the reproducibility of the appearance of biological tissue in a tissue model or organ model. Preferably, such a color pattern also exists within the composite. In other words, when a cross section of the composite is viewed, an irregular color pattern, a mosaic pattern of different colors, a color pattern in which different colors are randomly mixed, etc. can appear.

[0035] <1-4. Biological Model> The above-described tissue model or organ model can be appropriately combined with other components to be used as a biological model that mimics part or all of a living organism. The biological model may be, for example, a human body model or an animal model, or a partial model thereof. The biological model may be manufactured entirely by combining the above-described tissue models or organ models, or may be manufactured by combining the above-described tissue model or organ model with other components that are manufactured separately.

[0036] 2. Manufacturing Method of a Tissue Model or an Organ Model The manufacturing method of a tissue model or an organ model according to this embodiment includes the following steps: (a) a first material preparation step of preparing a first material containing a thermoplastic elastomer and an oil and having a first color, (b) a second material preparation step of preparing a second material containing a thermoplastic elastomer and an oil and having a second color different from the first color, and (c) a fusion step of fusing at least the first material and the second material while heating them. Hereinafter, the materials to be fused in step (c), such as the first material and the second material, will be collectively referred to as "base materials."

[0037] <2-1. First Material Preparation Step> In the first material preparation step, a first material having a first color is prepared. For example, the first material preparation step may include the following steps: (a1) heating a thermoplastic elastomer; (a2) adding oil to the thermoplastic elastomer that has been at least partially fluidized by heating, and mixing the mixture; (a3) ​​cooling and solidifying the mixture of the thermoplastic elastomer and the oil; and (a4) adding a colorant to the solidified mixture and mixing the mixture.

[0038] In step (a1), the heating temperature is not particularly limited as long as it fluidizes the thermoplastic elastomer and does not adversely affect other components. For example, the heating temperature in step (a1) is 100°C or higher and 250°C or lower, 130°C or higher and 220°C or lower, 150°C or higher and 210°C or lower, or 180°C or higher and 200°C or lower.

[0039] In step (a1), the time for which the heating temperature is maintained (hereinafter referred to as "heating time") is not particularly limited, as long as the thermoplastic elastomer is fluidized to the extent that it mixes with the oil. For example, the heating time in step (a1) is 1 minute or more and 30 minutes or less, preferably 5 minutes or more and 20 minutes or less. If the heating time is 1 minute or more, the thermoplastic elastomer and oil mix well. If the heating time is 30 minutes or less, unnecessary heating after the thermoplastic elastomer and oil have sufficiently mixed can be suppressed. However, the required heating time depends on the amounts of elastomer and oil, and is not limited to the above. For example, if there is a small amount of oil, a relatively long heating time may be required for fusion.

[0040] However, the first material preparation step is not limited to the steps (a1) to (a4) and their order as long as it contains a thermoplastic elastomer and an oil and produces a first material having a first color. For example, a colorant may be added to the thermoplastic elastomer or oil from the beginning. In step (a2), a colorant may be added together with the oil. Step (a4) may be proceeded to before sufficient cooling in step (a3) ​​(or step (a3) ​​may be omitted). In this case, cooling may be performed after step (a4), or step (c) may be proceeded to without cooling. If the thermoplastic elastomer or oil is colored, step (a4) may be omitted.

[0041] <2-2. Second Material Preparing Step> The second material preparing step can be performed in the same manner as the first material preparing step, except that the second material is prepared to have a second color different from the first color.

[0042] <2-3. Fusion Step> In the fusion step, the basic materials (here, the first material and the second material) prepared in steps (a) and (b) are fused together. Prior to the fusion step, the first material and the second material may be pulverized, for example, by grinding or pulverization. In the fusion step, the first material and the second material may be mixed non-uniformly. The arrangement of the first material and the second material during fusion may be determined so as to reproduce the appearance of the target tissue or organ. For details, see the sections below for each tissue or organ. Of course, basic materials other than the first material and the second material may also be combined.

[0043] The fusion can be performed by heating the first material and the second material. The heating means may be a device that performs localized heating, such as a heat gun, or a device that performs global heating, such as an oven. Preferably, the fusion process is performed by repeatedly applying localized heating (e.g., sequentially from the deepest layer to the most superficial layer). The heating temperature is not particularly limited as long as it fluidizes the thermoplastic elastomer and does not adversely affect other components. For example, the heating temperature in step (c) is 100°C or higher and 250°C or lower, 130°C or higher and 220°C or lower, 150°C or higher and 210°C or lower, or 180°C or higher and 200°C or lower.

[0044] In step (c), the heating time for maintaining the heating temperature is not particularly limited, as long as the thermoplastic elastomer is fluidized to the extent that the first material and the second material are fused together. However, when repeating localized heating as described above, it is preferable not to extend the heating time excessively (for example, to 1 minute or less) in order to limit the heated area to a localized range. For example, when using a heat gun at 250°C, it takes about 5 seconds to achieve mild local fusion, and about 30 to 45 seconds to melt more than half of the target area and then fuse it.

[0045] The composite obtained in the fusion step may be a tissue model by itself, or may be combined with a separately produced tissue model or organ model to form a tissue model or organ model. When the composite obtained in the fusion step is combined with a separately produced tissue model or organ model, a tissue model or organ model containing the composite can be obtained by fusing them while heating.

[0046] <3. Application to Various Tissues and Organs> Next, the application of the above-described tissue model or organ model to various biological tissues or organs will be described. Unless otherwise specified below, the descriptions in <1. Tissue model or organ model> and <2. Method for manufacturing a tissue model or organ model> above apply as is. Note that, rather than using the general tissue classifications of epithelial tissue, connective tissue, muscle tissue, and nerve tissue, the following description will focus on six representative examples for which there is a high demand for model production: adipose tissue, brain tissue, general organs, muscle tissue, tendon / connective tissue, and calcified tissue, for convenience in surgical training. However, the above-described tissue model or organ model is not limited to these tissues or organs, and can, of course, be applied to any tissue or organ.

[0047] <3-1. Adipose Tissue Model> The adipose tissue model is preferably relatively soft and has an irregular color pattern. The adipose tissue model can be manufactured by unevenly mixing multiple materials of different colors, heating them, and fusing them together. Furthermore, heating smooths the surface of the thermoplastic elastomer, allowing for a better reproduction of the texture of the membrane on the surface of adipose tissue.

[0048] In the adipose tissue model, it is preferable to add a relatively large amount of oil to soften it overall. For example, the content of oil contained in the adipose tissue model is, for example, 100 parts by mass to 1500 parts by mass, 300 parts by mass to 1200 parts by mass, or 600 parts by mass to 1000 parts by mass, based on 100 parts by mass of the thermoplastic elastomer contained in the adipose tissue model. Note that, in order to further improve the reproducibility of the texture of adipose tissue, it is effective to vary the amount of oil added for each differently colored component. Furthermore, the color intensity may be adjusted by the oil. In other words, the lighter the color of a plurality of components, the greater the oil content.

[0049] 3-2. Brain Tissue Model Similar to the fat tissue model, the brain tissue model is preferably relatively soft and has an irregular color pattern. A brain tissue model can be produced by unevenly mixing multiple materials of different colors, heating them, and fusing them together. The multiple materials can be fused together while being arranged to match the appearance of the brain.

[0050] As with the adipose tissue model, it is preferable to add a relatively large amount of oil to the brain tissue model to soften it overall. For example, the content of oil contained in the brain tissue model is, for example, 100 parts by mass or more and 1500 parts by mass or less, 300 parts by mass or more and 1000 parts by mass or less, or 400 parts by mass or more and 600 parts by mass or less, based on 100 parts by mass of the thermoplastic elastomer contained in the brain tissue model.

[0051] <3-3. General Organ Models> Unlike the adipose tissue model and the brain tissue model, general organ models can be produced by adding an outer layer to the surface of a molded body shaped to the target organ, rather than simply mixing multiple materials. The outer layer may cover the entire surface of the molded body, or only a portion of the surface of the molded body. The molded body material may be a single material, a homogeneous mixture of multiple materials, or a heterogeneous mixture of multiple materials. Similarly, the outer layer material may be a single material, a homogeneous mixture of multiple materials, or a heterogeneous mixture of multiple materials. When the molded body material and / or the outer layer material are composed of a heterogeneous mixture of multiple materials, the reproducibility of the appearance of the general organ can be improved.

[0052] The method for adding an outer layer to a molded body is not particularly limited, but any method can be used, such as applying a heated and fluidized outer layer material to the surface of the molded body, immersing the molded body in a solution of the outer layer material, or sprinkling a powder of the outer layer material on the surface of the molded body.

[0053] The content of oil contained in the molding material is, for example, 100 parts by mass or more and 600 parts by mass or less, or 200 parts by mass or more and 400 parts by mass or less, based on 100 parts by mass of the thermoplastic elastomer contained in the molding material.

[0054] The content of oil contained in the outer layer material is, for example, 100 parts by mass to 600 parts by mass, or 200 parts by mass to 400 parts by mass, based on 100 parts by mass of the thermoplastic elastomer contained in the outer layer material.

[0055] Preferably, the molded body and the outer layer are fused to each other at their interface. The molded body material and the outer layer material fuse and mix near the interface, forming an irregular color pattern. This improves the reproducibility of the appearance of a living organ. The fusion of the molded body and the outer layer can be achieved by heat treatment of the interface. The heat treatment may involve heating the entire molded body and outer layer, or may involve locally heating the vicinity of the interface (e.g., using a soldering iron or heat gun). The heating temperature is 100°C or higher and 250°C or lower, 130°C or higher and 220°C or lower, 150°C or higher and 210°C or lower, or 180°C or higher and 200°C or lower.

[0056] <3-4. Muscle Tissue Model> Muscle tissue models can be manufactured by adding fiber materials as reinforcing materials in addition to thermoplastic elastomers and oils. The addition of fiber materials allows for the reproduction of the texture of muscle fibers. Because muscle fibers generally extend in a specific direction, when manufacturing a muscle tissue model, a step of pulling the material in one direction after adding the fiber materials may be performed. The type of fiber material is not particularly limited, and may be natural fibers, synthetic fibers, or a mixture thereof. Examples of natural fibers include, but are not limited to, gampi fiber, natural cellulose (such as cotton), and heat-resistant fibers (flame-retardant fibers). Examples of synthetic fibers include, but are not limited to, polyester, nylon, and acrylic fibers.

[0057] In the case of a muscle tissue model, the reproduction of the appearance of muscle tissue can be improved by mixing and fusing multiple materials of different colors. For example, if a first material containing a larger amount of fiber material and a second material containing a smaller amount of fiber material have different colors due to the change in light scattering intensity caused by the amount of fiber material, a muscle tissue model that more accurately reproduces muscle tissue can be obtained by mixing and fusing such first and second materials.

[0058] The oil content in the material of the muscle tissue model is, for example, 30 parts by mass or more and 400 parts by mass or less, 50 parts by mass or more and 300 parts by mass or less, or 80 parts by mass or more and 200 parts by mass or less, based on 100 parts by mass of the thermoplastic elastomer contained in the material.

[0059] The content of the fiber material contained in the material of the muscle tissue model is, for example, 0.01 parts by mass to 5 parts by mass, 0.05 parts by mass to 1 part by mass, or 0.1 parts by mass to 0.5 parts by mass, based on 100 parts by mass of the thermoplastic elastomer contained in the material.

[0060] The fibrous material may be added when the thermoplastic elastomer is heated and oil is added, or the mixture of the thermoplastic elastomer and oil may be cooled and then reheated and added. The heating temperature when adding the fibrous material is 100°C or higher and 250°C or lower, 130°C or higher and 200°C or lower, or 150°C or higher and 180°C or lower.

[0061] 3-5. Tendon / Connective Tissue Model The tendon tissue model and connective tissue model (hereinafter collectively referred to as "tendon / connective tissue model") can be used in combination with other tissue models or organ models as models of tendon tissue and connective tissue that connect tissues. For example, the tendon / connective tissue model can be fused to other tissue models or organ models by heating. For example, the connective tissue model can be fused to two tissue models, respectively, to join the two tissue models.

[0062] The tendon / connective tissue model may be manufactured using a thermoplastic elastomer, oil, and a fiber material as a reinforcing material, similar to the muscle tissue model. Considering the actual appearance of tendon and connective tissue, the tendon / connective tissue model may be colorless. However, if the fiber material absorbs, reflects, and / or scatters light, it can also function as a colorant.

[0063] The oil content in the material of the tendon / connective tissue model is, for example, 100 parts by mass or more and 600 parts by mass or less, 150 parts by mass or more and 400 parts by mass or less, or 200 parts by mass or more and 300 parts by mass or less, based on 100 parts by mass of the thermoplastic elastomer contained in the material.

[0064] The content of the fiber material contained in the material of the tendon / connective tissue model is, for example, 0.01 to 5 parts by mass, 0.05 to 1 part by mass, or 0.1 to 0.5 parts by mass, based on 100 parts by mass of the thermoplastic elastomer contained in the material.

[0065] The fibrous material may be added when the thermoplastic elastomer is heated and oil is added, or the mixture of the thermoplastic elastomer and oil may be cooled and then reheated and added. The heating temperature when adding the fibrous material is 100°C or higher and 250°C or lower, 130°C or higher and 200°C or lower, or 150°C or higher and 180°C or lower.

[0066] 3-6. Calcified Tissue Model The calcified tissue model can be used in combination with other tissue models or organ models as a component that mimics calcified tissue in the body. For example, the calcified tissue model can be fused to another tissue model by heating. By fusing the calcified tissue model to another tissue model, it is possible to reproduce a partially calcified tissue.

[0067] The calcified tissue model can be manufactured by adding hard particles to a thermoplastic elastomer. Unlike the models described above, the calcified tissue model does not necessarily contain oil. The hard particles are particles of a material that is harder than the thermoplastic elastomer at room temperature. Preferably, the hard particles are white. The type of hard particles is not particularly limited, but may be, for example, calcium carbonate-containing particles having a predetermined particle size. Examples of calcium carbonate-containing particles include, but are not limited to, calcium carbonate particles, eggshells, and seashells.

[0068] The particle size of the hard particles is, for example, 0.1 mm to 5 mm, or 0.3 mm to 1 mm. If the particle size is 0.1 mm or more, the hardened texture of calcified tissue can be reproduced. If the particle size is 5 mm or less, the loss of realism of calcified tissue due to excessively large hard particles can be suppressed.

[0069] The content of oil contained in the material for the calcified tissue model is, for example, 0 to 400 parts by mass, 50 to 300 parts by mass, or 100 to 200 parts by mass, based on 100 parts by mass of the thermoplastic elastomer contained in the material. The content of hard particles contained in the material for the calcified tissue model is, for example, 1 to 50 parts by mass, or 10 to 20 parts by mass, based on 100 parts by mass of the thermoplastic elastomer contained in the material.

[0070] The heating temperature when adding the hard particles is 100°C or higher and 250°C or lower, 130°C or higher and 220°C or lower, 150°C or higher and 210°C or lower, or 180°C or higher and 200°C or lower.

[0071] <3-7. Others> In addition to the above, models of various tissues or organs, such as blood vessels, epithelial tissue, nerve tissue, and cartilage, can be manufactured. The manufactured tissue models or organ models can be combined in any manner. Note that the manufactured tissue models or organ models may be combined with tissue models or organ models obtained by methods other than those described above (for example, commercially available).

[0072] For example, by incorporating a manufactured tissue model or organ model that mimics tumor cells or tumor tissue but has a different hardness from the tissue model or organ model, the presence of tumor cells or tumor tissue in the tissue or organ imitated by the manufactured tissue model or organ model can be more realistically reproduced. Furthermore, by adjusting the adhesiveness or detachability between the manufactured tissue model or organ model and the other tissue model or organ model imitating tumor cells or tumor tissue, it is possible to express the benignity or malignancy of the tumor cells or tumor tissue. For example, by improving the detachability between the manufactured tissue model or organ model and the other tissue model or organ model imitating tumor cells or tumor tissue, the benignity of the imitated tumor cells or tumor tissue can be more realistically expressed. Here, "realistic" refers not only to the general meaning, but also to the sense that the appearance, tactile sensation, operation, response, and behavior are similar to or feel similar to the actual appearance, tactile sensation, and response and behavior during actual surgery.

[0073] 4. Generation of Data Set and Training Next, generation of a data set for training a surgical robot using the tissue model or organ model will be described.

[0074] The method for generating a dataset according to this embodiment includes the following steps: (A) an acquisition step of acquiring images of a simulated surgery using the tissue model or organ model and surgical information related to the simulated surgery that is associated with the images; and (B) a generation step of generating a dataset for surgical training that associates the images with the surgical information.

[0075] The simulated surgery may be performed by a human, a machine such as a surgical robot, or a collaboration between a human and a machine. In the simulated surgery, the tissue model or organ model is used as at least a part of the surgical subject. In this specification, the term "image" includes still images and videos. The image may be, for example, a still image or video captured of part or all of the simulated surgery.

[0076] The surgery information is any information related to the simulated surgery. Examples of the surgery information include, but are not limited to, the tissue or organ to be operated on, the name and severity of the injury or illness of the surgical patient, attributes such as the age and sex of the patient expected to be operated on, the details of the simulated surgery (e.g., the name of the surgery, the instruments used, and the duration of the surgery), the proficiency of the surgeon, and an evaluation of the simulated surgery (e.g., success, failure, or the presence or absence of errors).

[0077] The association of images of the simulated surgery with surgical information may be performed by a human, a computer, or a collaboration between a human and a computer. For example, a computer can accept input of surgical information for each simulated surgery from a surgeon who performed the simulated surgery, and store the images of the simulated surgery in association with the input surgical information. The computer can acquire a large amount of data in which surgical images and surgical information are associated, and compile this data to generate a dataset for surgical training. A surgical robot can learn surgery using a dataset in which images of the simulated surgery are associated with surgical information. For example, a surgical robot can learn the relationship between surgical movements in various situations and evaluations of the surgical movements.

[0078] The instructions shown in the processing steps in the above-described data set generation method can be executed based on a software program. The instructions are recorded as a program that can be executed by an information processing device such as a computer on a magnetic disk (such as a flexible disk or hard disk), an optical disk (such as a CD-ROM, CD-R, CD-RW, DVD-ROM, DVD±R, DVD±RW, or Blu-ray (registered trademark) Disc), a semiconductor memory, or a similar non-transitory computer-readable recording medium. The computer can realize operations similar to the above-described processing steps by reading the program from the recording medium and having the CPU execute the instructions described in the program based on the program. The computer may also acquire or read the program via a network.

[0079] When executed by a processor of a computer, the program for generating a dataset according to this embodiment causes the processor to perform the following processes: (A) an acquisition process for acquiring images of a simulated surgery on the tissue model or organ model and surgical information related to the simulated surgery; and (B) a generation process for generating a dataset for surgical training by associating the images with the surgical information.

[0080] The information processing device that generates a dataset according to this embodiment includes: (A) an acquisition unit that acquires images of a simulated surgery using the tissue model or organ model and surgical information related to the simulated surgery that is associated with the images; and (B) a generation unit that generates a dataset for surgical training that associates the images with the surgical information.

[0081] An information processing device refers to any device that processes information, such as a computer. Fig. 1 is a diagram showing the hardware configuration of an information processing device 10. As shown in Fig. 1, the information processing device 10 has, for example, a processor 11, a memory 12, a storage 13, an input / output IF (interface) 14, a communication IF 15, and a bus 16 as its hardware configuration. The processor 11, the memory 12, the storage 13, the input / output IF 14, and the communication IF 15 are electrically connected via the bus 16 inside the information processing device 10.

[0082] The processor 11 is hardware that processes data and instructions written in a program, and is composed of, for example, a control unit, an arithmetic unit, and a register.

[0083] The memory 12 is hardware that temporarily stores programs and data, and is, for example, a volatile memory such as a static random access memory (SRAM) or a dynamic random access memory (DRAM).

[0084] The storage 13 is hardware that stores programs and data, and is, for example, a non-volatile memory such as a flash memory, a hard disk drive (HDD), or a ferroelectric memory.

[0085] The input / output IF 14 functions as an interface with an input device that accepts input operations from the user and an output device that presents information to the user. Examples of input devices include pointing devices such as a mouse or a touch panel, a keyboard, and a microphone. Examples of output devices include a display and a speaker. The input device and the output device may be configured integrally with the information processing device 10 or may be externally attached.

[0086] The communication IF 15 is an interface that inputs and outputs signals for communicating with external devices. The information processing device 10 communicates with other devices via a network (such as the Internet or an intranet) using the communication IF 15. Specifically, the communication IF 15 transmits data output from the processor 11 to other devices. The communication IF 15 also receives data transmitted from other devices and transmits the data to the processor 11. The communication method is not particularly limited, and one or more of known communication methods such as wired LAN network communication, wireless LAN network communication, mobile communication such as 3G / LTE / 5G, USB, IEEE 1394, Thunderbolt (registered trademark), and BLUETOOTH (registered trademark) can be used.

[0087] The machine learning method (i.e., the method for generating a trained model) using the above dataset and the trained model will be further described.

[0088] The method for generating a trained model according to this embodiment includes the following steps (i) or (ii): (i) training a machine learning model using images of a simulated surgery using the tissue model or organ model and surgical information related to the simulated surgery; and (ii) training a machine learning model using a dataset generated by the dataset generation method.

[0089] The images of the simulated surgery may include one or more of preoperative, intraoperative, and postoperative images of the simulated surgery. The surgery information may include information about the details or method of the surgery and information about the results of the surgery. Information about the details or method of the surgery may include, but is not limited to, the name of the surgery, the site, the route of the surgery, the instruments used, the name of the symptom, and patient information (e.g., age, sex, weight, height, test data, medical history, medication history, and drug history).

[0090] The learning of the machine learning model does not necessarily have to be performed using only one or both of the images of the simulated surgery and the dataset, but may also be performed using other images or datasets in combination.

[0091] The trained model according to this embodiment is a trained model for surgery or surgical assistance that has been trained using images of a simulated surgery using the tissue model or organ model and surgical information related to the simulated surgery that is associated with the images. When executed by a computer processor, the trained model causes the processor to control the computer or surgical equipment connected to the computer and perform the following steps (a) or (b): (a) a step of causing the surgical equipment to perform surgery autonomously or in cooperation with other equipment or a human; and (b) a step of causing the computer or surgical equipment to assist in performing the surgery.

[0092] A surgical instrument is a device that can perform or assist in the performance of surgery. An example of a surgical instrument is a surgical robot. The surgical instrument may be connected to a computer by wire or wirelessly and controlled by the computer's processor.

[0093] Here, "assisting in the implementation of surgery" includes, but is not limited to, one or more of the following: Assistance during surgery: analysis of moving images, adjustment of lighting position, automatic adjustment of the surgical field, presentation of surgical sites from similar surgeries in the past, etc. Assistance before surgery: surgery simulation, etc. Assistance after surgery: prediction of postoperative progress, etc.

[0094] The trained model may be a machine learning model that learns the relationship between input and output, using images of a surgical procedure as input and surgical information such as the status of the surgical site (e.g., disease name, status (presence or absence of bleeding, likelihood of bleeding), extent of pathology), appropriate surgical method (name of the procedure if there is a name), surgical content, surgical route, necessary instruments and equipment, surgical area, and surgical results. A trained model trained in this way can accept input of an image of the surgical site and output one or more values ​​selected from the group consisting of the status of the surgical site, appropriate surgical method, surgical content, surgical route, necessary instruments and equipment, surgical area, and estimated surgical results.

[0095] The trained model may be a machine learning model that learns the relationship between an input and output, with an image of the surgical site together with surgical information such as the surgical content as input and the results of the surgery as output. A trained model can accept inputs of images and surgical information and output an estimate of the postoperative outcome (preoperative simulation).

[0096] The tissue or organ model described above can improve realism by reproducing biological tissue or organs using multiple parts of different colors. Conventionally, it has been difficult to publish actual surgical images, including failed cases, as training datasets for surgical robots, and it has also been difficult to create large quantities of animal surgical images due to ethical concerns. However, by using the tissue or organ model with improved realism described above, it is possible to easily create training datasets for surgical robots.

[0097] The present invention will be described below with reference to experimental examples, but the present invention is not limited to the following experimental examples.

[0098] Experimental Example 1: Production of base material First, a base material that would become the basis for the tissue model and organ model was produced from a thermoplastic elastomer and oil. The thermoplastic elastomer used was a styrene-based elastomer (product name: AR-SC-0, manufactured by Aron Kasei Co., Ltd., containing 3-4 g of oil per 10 g). The oil used was liquid paraffin (manufactured by Kosakai Pharmaceutical Co., Ltd.).

[0099] First, the thermoplastic elastomer was heated to 200°C, and oil was added and mixed in this state. The mixing ratio of thermoplastic elastomer to oil was set according to the type of tissue or organ to be produced. Next, a yellow transparent pigment (manufactured by Holbein) was added and mixed until the color was uniform throughout. After that, the mixture was cooled to room temperature, and a colored block-shaped elastomer-oil composite was obtained.

[0100] Experimental Example 2: Fabrication of Adipose Tissue Model In fabricating the adipose tissue model, the mass ratio of thermoplastic elastomer to oil was set to 1:6 to 1:12 (volume ratio: 1:2 to 1:5) during the fabrication of the base material. By adjusting the amount of oil added, four colors of base materials were fabricated: light yellow, transparent white, orange, and transparent yellow. These base materials were placed in a mortar or blender, mixed while being ground, and heated with a heat gun at 250°C for approximately 5 to 30 seconds to fuse the ground materials together. The four colors of base materials were mixed in appropriate amounts and mixed heterogeneously to reproduce the appearance of adipose tissue. The mixed base materials melted and fused together upon heating to form a composite. The surface of the resulting composite was then heated to approximately 130°C to 150°C to smooth it. Figure 2 shows a photograph of the fabricated adipose tissue model. As shown in Figure 2, it was confirmed that the adipose tissue model formed an overall heterogeneous color pattern.

[0101] Experimental Example 3: Production of brain tissue model A brain tissue model was produced in the same manner as Experimental Example 2, except that the mass ratio of thermoplastic elastomer to oil was set to approximately 1:4 to 1:5.7, and the blending amounts of the above four colored basic materials were changed to reproduce the appearance of brain tissue. In order to mold it into the shape of a brain, a rough shape was formed using a mold, and then the fine shape was molded during heating.

[0102] Experimental Example 4: Manufacturing a General Organ Model In manufacturing a general organ model, a main base material with a main color was manufactured by adding a pigment of a main color at a mass ratio of thermoplastic elastomer to oil of approximately 1:1.7 to 1:3.3. Furthermore, a secondary base material with a secondary color different from the main color was manufactured by adding a pigment of a secondary color different from the main color at a mass ratio of thermoplastic elastomer to oil of approximately 1:1.7 to 1:3.3. Here, to reproduce the appearance of a general organ, multiple secondary base materials of different colors were manufactured. A block-shaped auxiliary base material was shaved to make it smaller than the main base material. The block-shaped main base material was then molded into the desired organ shape. Multiple secondary base materials were unevenly applied to the surface of the molded organ shape to reproduce the appearance of a general organ. The main base material and the secondary base material were then fused together by heating at 200°C to obtain a general organ model. To mold the organ shape, a rough shape was formed using a mold, and then the fine shape was molded during heating.

[0103] It was confirmed that the texture of the organ was reproduced on the surface of the obtained organ model by the auxiliary base material. Furthermore, when the obtained organ model was cut, it was confirmed that fusion of the main base material and the auxiliary base material occurred at the joint surface between the two materials, resulting in the formation of a non-uniform color pattern. Similarly, it was confirmed that non-uniform color patterns were also formed at the joint surfaces between multiple auxiliary base materials on the surface of the organ shape due to the fusion of different auxiliary base materials.

[0104] Experimental Example 5: Production of tendon / connective tissue models In producing the tendon and connective tissue models, a base material was produced without adding any pigment, with the mass ratio of thermoplastic elastomer to oil set at approximately 1:1.7 to 1:5. Approximately 0.01 to 0.1 parts by mass of decolorized gampi fiber was added to 100 parts by mass of the base material, and the mixture was heated to 160°C and molded to obtain the tendon and connective tissue models.

[0105] Experimental Example 6: Production of a calcified tissue model Unlike the previous experiments, the calcified tissue model was produced by adding no pigment to the thermoplastic elastomer, but instead adding hard particles obtained by crushing eggshells, heating the mixture to 180°C, and molding. 217 parts by mass of oil and 17 parts by mass of eggshells were added to 100 parts by mass of thermoplastic elastomer. The eggshells were crushed unevenly to a particle size of approximately 0.3 mm to 1 mm.

[0106] Experimental Example 7: Fabrication of a Composite Model The fabricated fat model was brought into contact with a general organ model, and the contact area was heated with a soldering iron or heat gun to fabricate a composite model in which the fat model and the organ model were fused together. It was confirmed that the longer the heating time, the stronger the adhesion between the fat model and the organ model. Similarly, it was confirmed that tendon tissue models, connective tissue models, and calcified tissue models could be heat-fused and adhered to other tissue models or organ models.

Claims

1. A tissue or organ model comprising a composite including a plurality of parts fused together, each of the plurality of parts comprising a thermoplastic elastomer and an oil, and having different colors from one another.

2. The tissue or organ model according to claim 1, wherein the plurality of parts are fused together to form an irregular color pattern.

3. The tissue model or organ model according to claim 1 or 2, wherein the plurality of parts are three-dimensionally mixed and integrated.

4. The tissue or organ model according to claim 1 or 2, wherein the composite mimics adipose tissue.

5. The tissue or organ model according to claim 1 or 2, wherein the plurality of parts contain the thermoplastic elastomer and the oil in different mass ratios.

6. The tissue or organ model according to claim 1 or 2, wherein each of the plurality of parts contains 100 to 1,500 parts by mass of the oil, based on 100 parts by mass of the thermoplastic elastomer.

7. The tissue or organ model according to claim 1 or 2, wherein the thermoplastic elastomer comprises one or more selected from the group consisting of styrene-based thermoplastic elastomers, olefin-based thermoplastic elastomers, urethane-based thermoplastic elastomers, ester-based thermoplastic elastomers, acrylic-based thermoplastic elastomers, and amide-based thermoplastic elastomers.

8. The tissue or organ model according to claim 1 or 2, wherein the oil comprises one or more selected from the group consisting of paraffinic oil, naphthenic oil, synthetic hydrocarbon oil, ester oil, ether oil, silicone oil, fluorinated oil, vegetable oil, and animal oil.

9. The tissue or organ model according to claim 1 or 2, further comprising a tendon tissue model that imitates tendon tissue or a connective tissue model that imitates connective tissue, wherein the tendon tissue model or the connective tissue model includes a fibrous material.

10. The tissue or organ model according to claim 1 or 2, further comprising a calcified tissue model that mimics calcified tissue, the calcified tissue model including hard particles.

11. A biological model comprising the tissue model or organ model according to claim 1 or 2.

12. A method for manufacturing a tissue model or an organ model, comprising: a first material preparation step of preparing a first material containing a thermoplastic elastomer and an oil and having a first color; a second material preparation step of preparing a second material containing a thermoplastic elastomer and an oil and having a second color different from the first color; and a fusion step of fusing at least the first material and the second material while heating.

13. The method of claim 12, wherein at least one of the first material preparation step and the second material preparation step includes mixing the thermoplastic elastomer and the oil while heating, followed by cooling.

14. A method for generating a dataset, comprising the steps of: acquiring images of a simulated surgery using a tissue model or organ model according to claim 1 or 2, and surgical information relating to the simulated surgery that is associated with the images; and generating a dataset for surgical training that associates the images with the surgical information.

15. A trained model for surgery or surgical assistance, trained using images of a mock surgery using a tissue model or organ model as described in claim 1 or 2 and surgical information related to the mock surgery associated with the images, which, when executed by a computer processor, causes the processor to control the computer or surgical equipment connected to the computer and perform the following steps (a) or (b): (a) a step of causing the surgical equipment to perform the surgery autonomously or in collaboration with other equipment or a human; (b) a step of causing the computer or the surgical equipment to assist in the performance of the surgery.

Images