Tissue models or organ models, biological models, methods for manufacturing tissue models or organ models, methods for generating datasets, and trained models.

Abstract

This invention provides a tissue model or organ model with improved realism, and a method for manufacturing a tissue model or organ model. [Solution] The tissue model or organ model according to the embodiment comprises a composite including a plurality of parts fused together, each of which contains a thermoplastic elastomer and an oil and has a different color from each other.

Description

Technical Field

[0001] Embodiments of the present invention relate to tissue models or organ models, biological models, methods for manufacturing tissue models or organ models, methods for generating datasets, and trained models.

Background Art

[0002] Mock tissues or mock organs for doctor training are known (Patent Document 1).

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] The inventors conceived of using images (still images or moving images) of surgically simulating a biological model as training data for a surgical robot. Currently commercially available biological models are simple for doctor surgical procedure training, and most lack realism. However, for a surgical robot that performs surgical operations according to the situation through image recognition, it is desirable that the training image data be as close as possible to real surgical images. Therefore, the inventors completed the present invention for the purpose of providing a technology capable of improving the realism of biological models.

[0005] The problem to be solved by 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.

Means for Solving the Problems

[0006] To solve the above problems, the inventor conceived the idea that the color tones of biological tissue could be better reproduced by using multiple parts of different colors in combination. After diligent research, the inventor discovered that the reproducibility of biological tissue can be improved by constructing multiple parts of different colors from thermoplastic elastomer and oil, and then heating and fusing them together.

[0007] The present invention may include the following embodiments. [1] A composite comprising multiple parts fused together, Each of the aforementioned components contains a thermoplastic elastomer and oil, and has a different color from one another. Tissue model or organ model. [2] The plurality of parts fuse together to form an irregular color pattern. [1] A tissue model or organ model as described above. [3] An irregular color pattern is formed on at least the surface of the composite, A tissue model or organ model as described in [1] or [2]. [4] An irregular color pattern is formed at least inside the composite, A tissue model or organ model described in any one of the following [1] to [3]. [5] The aforementioned multiple components are mixed together in three dimensions and integrated into one unit. A tissue model or organ model described in any one of the following [1] to [4]. [6] The composite as a whole mimics one type of tissue, A tissue model or organ model described in any one of the following [1] to [5]. [7] The complex mimics adipose tissue, A tissue model or organ model described in any one of the following [1] to [6]. [8] The plurality of components include the thermoplastic elastomer and the oil in different mass ratios from each other. A tissue model or organ model described in any one of [1] to [7]. [9] Each of the plurality of parts contains 100 parts by mass of the thermoplastic elastomer and 100 to 1500 parts by mass of the oil, A tissue model or organ model described in any one of [1] to [8].

[10] 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. A tissue model or organ model described in any one of [1] to [9].

[11] The oil comprises one or more selected from the group consisting of paraffinic oils, naphthenic oils, synthetic hydrocarbon oils, ester oils, ether oils, silicone oils, fluorinated oils, vegetable oils, and animal oils. A tissue model or organ model described in any one of [1] to

[10] .

[12] Further comprising a tendon tissue model mimicking tendon tissue or a connective tissue model mimicking connective tissue, The aforementioned tendon tissue model or connective tissue model includes a fibrous material. A tissue model or organ model described in any one of [1] to

[11] .

[13] The tendon tissue model or the connective tissue model is fused to the complex.

[12] A tissue model or organ model as described above.

[14] Further equipped with a calcified tissue model that mimics calcified tissue, The aforementioned calcified tissue model contains hard particles, A tissue model or organ model described in any one of the following [1] to

[13] .

[15] The calcified tissue model is fused to the composite,

[14] A tissue model or organ model as described above. A living organism model, including any tissue or organ model described in any one of

[16] [1] to

[15] .

[17] A method for manufacturing tissue models or organ models, 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, A fusing step of fusing at least the first material and the second material while heating, A method including the above.

[18] At least one of the first material preparation step and the second material preparation step includes heating and mixing the thermoplastic elastomer and the oil, and then cooling, The method according to

[17] .

[19] The heating temperature when heating and mixing the thermoplastic elastomer and the oil is 100°C or higher and 250°C or lower, The method according to

[18] .

[20] The fusing step includes unevenly mixing the first material and the second material, The method according to any one of

[17] to

[19] .

[21] The heating temperature in the fusing step is 100°C or higher and 250°C or lower, The method according to any one of

[17] to

[20] .

[21] A method for generating a dataset, A step of obtaining an image obtained by photographing a simulated operation using the tissue model or organ model according to any one of [1] to

[15] and operation information regarding the simulated operation associated with the image, A step of generating a dataset for surgical training by associating the image and the operation information, A method for generating a dataset including the above.

[22] A program for generating a dataset, When executed by a processor of a computer, the processor is caused to A step of obtaining an image obtained by photographing a simulated operation using the tissue model or organ model according to any one of [1] to

[15] and operation information regarding the simulated operation associated with the image, A step of generating a dataset for surgical training in which the image and the surgical information are associated with each other; A program that causes the above to be executed.

[23] An information processing apparatus, Comprising a processor, The processor, Obtains an image obtained by photographing a simulated surgery using the tissue model or organ model according to any one of [1] to

[15] , and surgical information regarding the simulated surgery associated with the image, Generates a dataset for surgical training in which the image and the surgical information are associated with each other, Information processing apparatus.

[24] An information processing apparatus, Comprising a processor and a memory, The memory stores, in association with each other, an image obtained by photographing a simulated surgery using the tissue model or organ model according to any one of [1] to

[15] , and surgical information regarding the simulated surgery, The processor generates a dataset for surgical training in which the image and the surgical information are associated with each other, Information processing apparatus.

[25] A learned model for surgery or surgical assistance, Learned using an image obtained by photographing a simulated surgery using the tissue model or organ model according to any one of [1] to

[15] , and surgical information regarding the simulated surgery associated with the image, When executed by a processor of a computer, causes the processor to control the computer or surgical equipment connected to the computer to execute the following step (a) or (i): (a) A step of causing the surgical equipment to perform surgery autonomously or in cooperation with other equipment or humans; (i) A step of assisting the computer or the surgical equipment in performing surgery.

[26] In step (a) above, the assistance includes one or more selected from the group consisting of analysis of video footage during surgery, adjustment of lighting position during surgery, automatic adjustment of the surgical field during surgery, presentation of surgical sites from similar past surgeries during surgery, preoperative surgical simulation, and prediction of postoperative progress. The pre-trained model described in

[25] .

[27] Accepts an image of the surgical site and outputs one or more selected from a group consisting of the condition of the surgical site, appropriate surgical method, surgical procedure, surgical route, necessary instruments and equipment, surgical area, and estimation of the surgical outcome. A pre-trained model as described in

[25] or

[26] .

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

[25] to

[27] , The aforementioned generation method is A step of training a machine learning model using images of a simulated surgery performed using any one of the tissue or organ models described in [1] to

[15] , and surgical information relating to the said simulated surgery; or The steps include training a machine learning model using the dataset generated by the method described in

[21] , Method for generating pre-trained programs.

[29] The above images include one or more of the preoperative, intraoperative, and postoperative images. The aforementioned surgical information includes information regarding the content or method of the surgery and information regarding the outcome of the surgery. The method described in

[28] . [Effects of the Invention]

[0008] According to the present invention, it is possible to provide tissue models or organ models with improved realism, and methods for manufacturing tissue models or organ models. [Brief explanation of the drawing]

[0009] [Figure 1] A diagram showing the hardware configuration of an information processing device. [Figure 2]A photograph of the adipose tissue model prepared in Example 2. [Modes for carrying out the invention]

[0010] The following describes the embodiments of tissue models or organ models, biological models, methods for manufacturing tissue models or organ models, methods for generating datasets, and trained models. Note that the following embodiments represent one aspect of the present invention and are not limiting, and can be modified as needed within the scope of the technical idea of ​​the present invention. Furthermore, each configuration and feature of the embodiments can be combined as desired.

[0011] The inventors have found that by constructing multiple parts of different colors from thermoplastic elastomer and oil, and then heating and fusing them together, it is possible to manufacture models of various tissues or organs with improved realism (e.g., appearance or texture). In this specification, "appearance" includes not only the external appearance of the tissue or organ, but also the appearance of the internal structure exposed when they are cut open.

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

[0013] <1. Tissue model or organ model> The tissue model or organ model according to this embodiment comprises a composite including a plurality of parts fused together, each of which contains a thermoplastic elastomer and oil and has a different color from one another. In this specification, "fusion" means that two dissimilar materials are mixed and bonded together at the interface between them. "Different colors" means that the colors are different to a degree that is distinguishable to the normal human eye.

[0014] <1-1. Materials> To reproduce the texture of biological tissue or organs, the components constituting a tissue model or organ model may be manufactured by mixing thermoplastic elastomers and oils. 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" means reducing the average transmittance in the visible light region (380 nm to 780 nm) of the object, and may include the addition of materials that absorb or reflect light, and materials that scatter light. The following describes each material.

[0015] <1-1-1. Thermoplastic elastomers> Thermoplastic elastomers function as base materials for tissue or organ models. Because the base material is thermoplastic, the parts can be fused together by heat treatment. This results in excellent manufacturing efficiency for tissue or organ models. Furthermore, tissue or organ models used in surgical training can be reused for surgical training by heating and reshaping them back to their original form.

[0016] 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.

[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 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 block copolymers having a polyurethane block as a hard segment and a polyester block or polyether block as a soft segment.

[0020] Examples of ester-based thermoplastic elastomers include polyester-polyether block copolymers 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 multiple polymer blocks composed of alkyl methacrylate units or alkyl acrylate units.

[0022] Examples of amide-based thermoplastic elastomers include copolymers having a polyamide block as a hard segment and a polyether block as a soft segment.

[0023] <1-1-2. Oil> By adding oil to thermoplastic elastomers, the physical properties of the parts, such as their elastic modulus and hardness, can be adjusted. This improves the accuracy of reproducing the texture of biological tissues or organs. The type and amount of oil added can be appropriately determined depending on the type of tissue or organ being targeted.

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

[0025] The oil content in the tissue model or organ model as a whole is, for example, 100 parts by mass or more and 1500 parts by mass or less, relative to 100 parts by mass of thermoplastic elastomer. 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, relative to 100 parts by mass of thermoplastic elastomer.

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

[0027] <1-1-3. Colorants> The coloring agent is not particularly limited as long as it can color the object, and any material such as pigments, dyes, paints, particles, or fibers can be used. If the part being manufactured is colorless and transparent, the use of a coloring agent is unnecessary. However, even if the part is colorless (white), if it is semi-transparent or opaque, the part can be colored by adding a light-scattering material, such as particles or fibers, as a coloring agent. Furthermore, if the thermoplastic elastomer or oil itself has color, the use of a coloring agent is not necessary.

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

[0029] The amount of coloring agent contained in the tissue model or organ model is, for example, 0.1 parts by mass or more and 5 parts by mass or less, based on 100 parts by mass of thermoplastic elastomer contained in the tissue model or organ model. If the amount of coloring agent is 0.1 parts by mass or more, the color of biological tissue can be reproduced to a minimum extent. If the amount of coloring agent is 5 parts by mass or less, the excessive use of colorants can be suppressed. Preferably, the amount of coloring agent is 0.2 parts by mass or more and 2 parts by mass or 0.5 parts by mass or more and 1 part by mass or less, based on 100 parts by mass of thermoplastic elastomer.

[0030] <1-2. Multiple parts and complexes> The tissue model or organ model according to this embodiment may have a composite made up of multiple parts having different colors in order to reproduce the appearance of living tissue or organs. The number of multiple parts is not particularly limited; for example, the composite may consist of two, three, four, or five or more parts. By having multiple parts with different colors from each other, the complex color variations and shades of living tissue or organs can be reproduced.

[0031] Multiple parts are fused together. This allows for the imitation of the connections between biological tissues and organs. Furthermore, the fusion and partial blending of parts with different colors can reproduce the natural coloration of biological tissue. However, it is not always necessary for the entire contact area between parts to be fused; there may simply be areas of physical contact.

[0032] A composite structure can take various forms depending on the shape, size, and arrangement of its multiple components. For example, a composite structure can take the form of multiple components intertwined and fused together, multiple components mixed together irregularly, or a form in which a second component is laminated on the surface of a first component. For example, multiple components may be mixed together in three dimensions to form a single unit. Here, "mixed together in three dimensions" means that the contact between components is not a single-point contact or a planar contact, but a three-dimensional contact. Multiple components can be integrated by fusing together. Examples include cases where multiple components are intertwined, or where the fusion interface between components has a large, uneven shape.

[0033] A complex can mimic one type of tissue as a whole. For example, a complex may mimic one type of tissue from among adipose tissue, brain tissue, muscle tissue, tendon tissue, connective tissue, and calcified tissue. However, it is not limited to this, and a complex may mimic two or more types of tissue. Furthermore, a tissue model or organ model may have two or more complexes. In this case, the tissue model or organ model may be formed as a tissue model or organ model that mimics multiple types of tissue by multiple complexes as a whole.

[0034] <1-3. Color Patterns> When multiple parts of different colors are mixed together, the composite can exhibit complex color patterns. For example, multiple parts may fuse together to form an irregular color pattern. Alternatively, multiple parts may 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 visual reproducibility of biological tissue in tissue models or organ models. Preferably, such color patterns also exist within the composite. That is, when a cross-section of the composite is viewed, irregular color patterns, mosaic patterns of different colors, and color patterns in which different colors are randomly mixed may appear.

[0035] <1-4. Biological Models> The tissue models or organ models described above can be combined with other parts as appropriate to be used as living models that mimic part or all of a living organism. The living models may be, for example, human body models, animal models, or partial models thereof. The entire living model may be manufactured by combining the tissue models or organ models described above, or by combining the tissue models or organ models described above with other parts manufactured separately.

[0036] <2. Method for manufacturing tissue models or organ models> The method for manufacturing a tissue model or organ model according to this embodiment includes the following steps. (a) A first material preparation step of preparing a first material comprising a thermoplastic elastomer and an oil and having a first color. (b) A second material preparation step of preparing a second material comprising a thermoplastic elastomer and an oil, having a second color different from the first color. (c) A fusion step in which at least the first material and the second material are fused together while being heated. In the following, each material that is fused in step (c), such as the first material and the second material, will be collectively referred to as the "basic material."

[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) Heat the thermoplastic elastomer. (a2) Add oil to the thermoplastic elastomer that has been at least partially fluidized by heating and mix. (a3) The mixture of thermoplastic elastomer and oil is cooled and solidified. (a4) Add the coloring agent to the solidified mixture and mix.

[0038] In step (a1), the heating temperature is not particularly limited, as long as it is a temperature at which the thermoplastic elastomer becomes fluid and does not adversely affect other components. For example, the heating temperature in step (a1) may be 100°C to 250°C, 130°C to 220°C, 150°C to 210°C, or 180°C to 200°C.

[0039] In step (a1), the time for which the above heating temperature is maintained (hereinafter referred to as "heating time") is not particularly limited, as long as the thermoplastic elastomer becomes fluid enough to mix 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 the oil will mix. If the heating time is 30 minutes or less, unnecessary heating after the thermoplastic elastomer and the oil have mixed sufficiently can be suppressed. However, the required heating time is not limited to the above, as it depends on the amount of elastomer and oil. For example, if there is little oil, heating for a relatively long time may be required for fusion.

[0040] However, the first material preparation step is not limited to the steps (a1) to (a4) above, and is only required to include a thermoplastic elastomer and an oil to obtain a first material having a first color. For example, a coloring agent may be added to the thermoplastic elastomer or oil from the beginning. In step (a2), a coloring agent may be added together with the oil. Before sufficient cooling in step (a3) ​​(or step (a3) ​​is omitted), the process may proceed to step (a4). In this case, cooling may be performed after step (a4), or the process may proceed to step (c) without cooling. If the thermoplastic elastomer or oil is colored, step (a4) may be omitted.

[0041] <2-2. Second Material Preparation Step> The second material preparation step can be carried out in the same manner as the first material preparation 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 base materials prepared in steps (a) and (b) (here, the first and second materials) are fused together. Before the fusion step, the first and second materials may be refined, for example, by grinding or pulverizing. In the fusion step, the first and second materials may be mixed unevenly. The arrangement of the first and second materials during fusion may be determined to reproduce the appearance of the target tissue or organ. See the following sections for details on each tissue or organ. Of course, other base materials besides the first and second materials may also be combined.

[0043] Fusion can be performed by heating the first and second materials. The heating means may be a device that performs localized heating, such as a heat gun, or a device that performs generalized heating, such as an oven. Preferably, the fusion process is performed by repeating localized heating (for example, sequentially from the deep side to the surface side). The heating temperature is not particularly limited as long as it is a temperature at which the thermoplastic elastomer becomes fluid and does not adversely affect other components. For example, the heating temperature in step (c) may be 100°C to 250°C, 130°C to 220°C, 150°C to 210°C, or 180°C to 200°C.

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

[0045] The composite obtained in the fusion step may be a tissue model on its own, or it may be combined with a separately manufactured tissue model or organ model to form a tissue model or organ model. When combining the composite obtained in the fusion step with a separately manufactured tissue model or organ model, the tissue model or organ model containing the composite can be obtained by fusing them together while heating.

[0046] <3. Application to various tissues and organs> Next, we will explain how to apply the above-mentioned tissue or organ models to various biological tissues or organs. Unless otherwise specified below, the descriptions in <1. Tissue or Organ Models> and <2. Method for Manufacturing Tissue or Organ Models> above will apply as is. In the following, instead of the general classification of tissues such as epithelial tissue, connective tissue, muscle tissue, and nerve tissue, we will explain six representative examples that have a high demand for model manufacturing for surgical training: adipose tissue, brain tissue, general organs, muscle tissue, tendon / connective tissue, and calcified tissue. However, it goes without saying that the above-mentioned tissue or organ models are not limited to these tissues or organs, but can be applied to any tissue or organ.

[0047] <3-1. Adipose tissue model> Models of adipose tissue are preferably relatively soft and have an irregular color pattern. Adipose tissue models 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 film on the surface of adipose tissue.

[0048] In adipose tissue models, it is preferable to add a relatively large amount of oil to make the model soft overall. For example, the oil content in an adipose tissue model may be 100 to 1500 parts by mass, 300 to 1200 parts by mass, or 600 to 1000 parts by mass, based on 100 parts by mass of thermoplastic elastomer contained in the adipose tissue model. To further improve the reproducibility of the texture of adipose tissue, it is effective to vary the amount of oil added for each part with a different color. The intensity of the color may also be adjusted with oil. That is, the oil content may be increased for lighter-colored parts among several parts.

[0049] <3-2. Brain tissue model> Brain tissue models, like adipose tissue models, are preferably relatively soft and have an irregular color pattern. Brain tissue models can be manufactured by unevenly mixing multiple materials of different colors, heating them, and fusing them together. The multiple materials can be fused together in an arrangement that matches the appearance of the brain.

[0050] In brain tissue models, similar to adipose tissue models, it is preferable to add a relatively large amount of oil to make the model soft overall. For example, the oil content in a brain tissue model may be 100 to 1500 parts by mass, 300 to 1000 parts by mass, or 400 to 600 parts by mass, based on 100 parts by mass of thermoplastic elastomer contained in the brain tissue model.

[0051] <3-3. General organ models> Unlike adipose tissue models and brain tissue models, general organ models can be manufactured not by simply mixing multiple materials, but by adding an outer layer to the surface of a molded body shaped to the target organ. The outer layer may cover the entire surface of the molded body or only a portion of its surface. The molded body material may be a single material, a mixture of multiple materials uniformly mixed, or a mixture of multiple materials unevenly mixed. Similarly, the outer layer material may be a single material, a mixture of multiple materials uniformly mixed, or a mixture of multiple materials unevenly mixed. When the molded body material and / or the outer layer material are composed of multiple materials unevenly mixed, the visual reproducibility of the general organ may be improved.

[0052] The method for adding an outer layer to a molded body is not particularly limited, but any method can be employed, 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 powder of the outer layer material onto the surface of the molded body.

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

[0054] The oil content in the outer layer material is, for example, 100 parts by mass or more and 600 parts by mass or 200 parts by mass or more and 400 parts by mass, with 100 parts by mass of 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. Near this interface, the molded body material and the outer layer material fuse and mix together, forming an irregular color pattern. This improves the reproducibility of the appearance of biological organs. 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 heating the area near the interface locally (for example, using a soldering iron or heat gun). The heating temperature is 100°C to 250°C, 130°C to 220°C, 150°C to 210°C, or 180°C to 200°C.

[0056] <3-4. Muscle tissue model> Muscle tissue models can be manufactured by adding fibrous material as a reinforcing material to thermoplastic elastomers and oils. The addition of fibrous material can reproduce the texture of muscle fibers. Since muscle fibers generally extend along a specific direction, a step of pulling the material in one direction may be performed after adding the fibrous material when manufacturing muscle tissue models. The type of fibrous material is not particularly limited and may be naturally derived fibers, synthetic fibers, or mixtures thereof. Examples of naturally derived fibers include, but are not limited to, gampi fibers, 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 muscle tissue models, the reproducibility of the appearance of muscle tissue can be improved by mixing and fusing together multiple materials with different colors. For example, if a first material containing more fibrous material and a second material containing less fibrous material have different colors due to variations in light scattering intensity depending on the amount of fibrous material, mixing and fusing these first and second materials can yield a muscle tissue model that better reproduces muscle tissue.

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

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

[0060] The fiber material may be added at the same time as heating the thermoplastic elastomer and adding the oil, or it may be added after the mixture of thermoplastic elastomer and oil has been cooled and then reheated. The heating temperature when adding the fiber material is 100°C to 250°C, 130°C to 200°C, or 150°C to 180°C.

[0061] <3-5. Tendon / connective tissue model> Tendon tissue models and connective tissue models (hereinafter collectively referred to as "tendon / connective tissue models") can be used in combination with other tissue models or organ models as models of tendon and connective tissue that connect tissues. For example, tendon / connective tissue models can be fused to other tissue models or organ models by heat. For example, two tissue models can be joined together by fusing a connective tissue model to two tissue models.

[0062] Tendon / connective tissue models, like muscle tissue models, can be manufactured using thermoplastic elastomers and oils, with the addition of fibrous materials as reinforcing materials. Considering the actual appearance of tendon and connective tissue, tendon / connective tissue models may be colorless. However, if the fibrous material absorbs, reflects, and / or scatters light, the fibrous material can also function as a coloring agent.

[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 150 parts by mass or more and 400 parts by mass or 200 parts by mass or more and 300 parts by mass or less, with 100 parts by mass of thermoplastic elastomer contained in the material.

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

[0065] The fiber material may be added at the same time as heating the thermoplastic elastomer and adding the oil, or it may be added after the mixture of thermoplastic elastomer and oil has been cooled and then reheated. The heating temperature when adding the fiber material is 100°C to 250°C, 130°C to 200°C, or 150°C to 180°C.

[0066] <3-6. Calcified tissue model> Calcified tissue models can be used in conjunction with other tissue or organ models as components that mimic calcified tissue in the body. For example, calcified tissue models can be fused to other tissue models by heat. By fusing calcified tissue models to other tissue models, it is possible to reproduce tissue that is partially calcified.

[0067] A 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 have to 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, between 0.1 mm and 5 mm, or between 0.3 mm and 1 mm. If the particle size is 0.1 mm or larger, the hardened texture of calcified tissue can be reproduced. If the particle size is 5 mm or smaller, it is possible to prevent the realism of the calcified tissue from being compromised by excessively large hard particles.

[0069] The oil content in the material of 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, with 100 parts by mass of thermoplastic elastomer contained in the material. The hard particle content in the material of the calcified tissue model is, for example, 1 to 50 parts by mass, or 10 to 20 parts by mass, with 100 parts by mass of thermoplastic elastomer contained in the material.

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

[0071] <3-7.B> 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 or organ models can be combined in any way. Furthermore, the manufactured tissue or organ models may be combined with tissue or organ models obtained by methods other than those described above (for example, commercially available models).

[0072] For example, a manufactured tissue or organ model can more realistically reproduce the presence of tumor cells or tumor tissue in the tissue or organ it mimics by embedding another tissue or organ model that mimics tumor cells or tumor tissue and has a different hardness than the manufactured tissue or organ model. Furthermore, by adjusting the adhesion and detachability between the manufactured tissue or organ model and the other tissue or organ model that mimics tumor cells or tumor tissue, it is possible to express the benign or malignant nature of the tumor cells or tumor tissue. For instance, by increasing the detachability between the manufactured tissue or organ model and the other tissue or organ model that mimics tumor cells or tumor tissue, it becomes possible to more realistically represent that the mimicked tumor cells or tumor tissue are benign. Here, "realistically" means, in addition to its general meaning, that the appearance, touch, movement, response, and behavior are close to or feel close to the actual appearance, touch, and actual response and behavior during surgery.

[0073] <4. Dataset Generation and Training> Next, we will describe the generation and training of a training dataset for surgical robots using the tissue or organ models described above.

[0074] The method for generating a dataset according to this embodiment includes the following steps. (A) Acquisition step of obtaining images of a simulated surgery using the tissue model or organ model described above, and surgical information related to the simulated surgery associated with the images. (B) Generation step to generate a dataset for surgical training that associates the above images with the above surgical information.

[0075] The above-described simulated surgery may be performed by a human, by a machine such as a surgical robot, or in collaboration with a human and a machine. In the simulated surgery, the above-described tissue model or organ model is used for at least a portion of the surgical target. In this specification, "image" includes still images and videos. The above-described images are, for example, still images or videos of part or all of the simulated surgery.

[0076] Surgical information is optional information related to a simulated surgery. Examples of surgical information include, but are not limited to, the tissue or organ to be operated on, the name and severity of the injury or illness being operated on, the age and sex of the patient being considered as the target of the surgery, the details of the simulated surgery (e.g., name of the surgery, instruments used, duration of the surgery), the skill level of the surgeon, and the evaluation of the simulated surgery (e.g., success, failure, presence or absence of errors).

[0077] The association between images of simulated surgeries and surgical information may be performed by a human, a computer, or collaboratively by a human and a computer. For example, a computer can receive input of surgical information for each simulated surgery from the surgeon who performed the 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 can combine this data to generate a dataset for surgical training. A surgical robot can learn surgery using this dataset in which images of simulated surgeries and surgical information are associated. For example, a surgical robot can learn the relationship between surgical movements in various situations and the evaluation of those surgical movements.

[0078] The instructions shown in the processing procedure of the dataset generation method described above are executable based on a software program. Each instruction is recorded as a program that can be executed by an information processing device such as a computer on a magnetic disk (flexible disk, hard disk, etc.), optical disk (CD-ROM, CD-R, CD-RW, DVD-ROM, DVD±R, DVD±RW, Blu-ray® Disc, etc.), semiconductor memory, or similar non-temporary computer-readable recording medium. The computer can read the program from this recording medium and, based on this program, have the CPU execute the instructions written in the program, thereby achieving the same operation as the processing procedure described above. The computer may also acquire or read the program via a network.

[0079] The program for generating the dataset according to this embodiment, when executed by a computer processor, causes the processor to perform the following processes. (A) Acquisition process to acquire images of a simulated surgery on the tissue model or organ model described above, and surgical information related to the simulated surgery. (B) Generation process to generate a dataset for surgical training by associating the images with the surgical information.

[0080] The information processing device for generating the dataset according to this embodiment includes the following: (A) An acquisition unit that acquires images of a simulated surgery using the above-mentioned tissue model or organ model, and surgical information related to the simulated surgery associated with the images. (B) Generation unit that generates a dataset for surgical training by associating the above images with the above surgical information.

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

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

[0083] Memory 12 is hardware that temporarily stores programs and data. For example, memory 12 is volatile memory such as SRAM (Static Random Access Memory) or DRAM (Dynamic Random Access Memory).

[0084] Storage 13 is hardware that stores programs and data. For example, storage 13 is non-volatile memory such as flash memory, HDD (Hard Disk Drive), or ferroelectric memory.

[0085] The input / output IF14 functions as an interface to an input device that accepts input operations from a user or other user, and an output device that presents information to the user. Examples of input devices include pointing devices such as a mouse or touch panel, a keyboard, and a microphone. Examples of output devices include a display and a speaker. The input and output devices may be integrated with the information processing device 10 or may be externally connected.

[0086] The communication IF 15 is an interface that inputs and outputs signals for communication with external devices. The information processing device 10 communicates with other devices via a network (Internet, intranet, etc.) 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 that data to the processor 11. The communication method is not particularly limited, and one or more known communication methods can be used, such as wired LAN network communication, wireless LAN network communication, mobile communication such as 3G / LTE / 5G, USB, IEEE1394, Thunderbolt®, and BLUETOOTH®.

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

[0088] The method for generating a trained model according to this embodiment includes the following steps (i) or (ii). (i) A step of training a machine learning model using images taken of a simulated surgery using the tissue model or organ model described above, and surgical information related to the simulated surgery. (ii) A step in which a machine learning model is trained using the dataset generated by the dataset generation method described above.

[0089] The images of the simulated surgery described above may include one or more pre-operative, intra-operative, and post-operative images of the simulated surgery. The surgical information described above may include information about the surgical procedure or method and information about the surgical outcome. Information about the surgical procedure or method may include, but is not limited to, the name of the surgery, the site, the surgical route, the instruments used, the name of the symptoms, and patient information (e.g., age, sex, weight, height, test data, medical history, medication history, drug use history).

[0090] The training of the machine learning model does not necessarily have to be performed using only the images of the simulated surgery and / or the dataset described above; other images or datasets may also be used in combination.

[0091] The trained model according to this embodiment is a trained model for surgery or surgical assistance, trained using images of a simulated surgery using the tissue model or organ model described above, and surgical information related to the simulated surgery associated with the images. When the trained model is executed by a computer processor, it causes the processor to control the computer or surgical instruments connected to the computer and to perform the following steps (a) or (b). (a) Steps to enable surgical instruments to perform surgery autonomously or in cooperation with other instruments or humans. (i) A step in which a computer or surgical instrument is used to assist in performing the surgery.

[0092] Surgical instruments are devices that can perform or assist in performing surgery. Examples of surgical instruments include surgical robots. Surgical instruments can be connected to a computer via wired or wireless means and controlled by the computer's processor.

[0093] Here, "assisting in the performance of surgery" includes, but is not limited to, one or more of the following items: • In-surgery support: video analysis, lighting position adjustment, automatic adjustment of the surgical field, presentation of surgical sites from similar past surgeries, etc. • Preoperative support: surgical simulation, etc. • Postoperative support: Predicting the prognosis, etc.

[0094] The above-described trained model may be a machine learning model that takes surgical images as input and outputs surgical information such as the condition of the surgical site (e.g., disease name, condition (presence or absence of bleeding, likelihood of bleeding), pathological extent), appropriate surgical method (surgical name if available), surgical procedure, surgical route, necessary instruments and equipment used, surgical area, and surgical outcome, and has learned the relationship between these inputs and outputs. A trained model trained in this way can accept an image of the surgical site as input and output one or more selected from the group consisting of the condition of the surgical site, appropriate surgical method, surgical procedure, surgical route, necessary instruments and equipment used, surgical area, and estimation of the surgical outcome.

[0095] The pre-trained model described above may be a machine learning model that takes images of the surgical site along with surgical information such as the details of the surgery as input, and outputs the results of the surgery, thereby learning the relationship between these inputs and outputs. A pre-trained model trained in this way can accept images and surgical information as input and output an estimate of the postoperative outcome (preoperative simulation).

[0096] As described above, tissue or organ models can be made more realistic by reproducing living tissue or organs with multiple parts of different colors. Traditionally, it has been difficult to create large datasets for training surgical robots using actual surgical images, as it is difficult to publish failure cases, and creating large datasets of animal surgical images is also difficult due to ethical issues. However, by using tissue or organ models with improved realism as described above, it is possible to easily create datasets for training surgical robots. [Examples]

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

[0098] <Experimental Example 1: Manufacturing of Basic Materials> First, basic materials for tissue and organ models were manufactured from thermoplastic elastomers and oils. For the thermoplastic elastomer, a styrene-based elastomer (product name: AR-SC-0, manufactured by Aron Kasei Co., Ltd., containing 3-4g of oil per 10g) was used. For the oil, liquid paraffin (manufactured by Kosakai Pharmaceutical Co., Ltd.) was used.

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

[0100] <Experimental Example 2: Manufacturing of adipose tissue models> In the production of the adipose tissue model, the mass ratio of thermoplastic elastomer to oil was set to 1:6 to 1:12 (volume ratio of 1:2 to 1:5) during the production of the basic materials. By adjusting the amount of oil added, four basic materials in light yellow, transparent white, orange, and transparent yellow were produced. These basic materials were placed in a mortar and pestle or mixer, mixed while being crushed, and heated with a heat gun at 250°C for about 5 to 30 seconds to fuse the crushed materials together. At this time, the four basic materials of the above colors were mixed unevenly in appropriate amounts to reproduce the appearance of adipose tissue. Each of the mixed basic materials melted and fused together upon heating, forming a composite. After that, the surface of the resulting composite was heated to about 130°C to 150°C to smooth it. Figure 2 shows a photograph of the produced adipose tissue model. As shown in Figure 2, it was confirmed that the adipose tissue model formed an uneven color pattern overall.

[0101] <Experimental Example 3: Manufacturing of a Brain Tissue Model> A brain tissue model was manufactured in the same manner as in 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 proportions of the four basic colored materials were changed to reproduce the appearance of brain tissue. In order to shape it into the form of a brain, the rough shape was formed using a mold, and then the finer details were formed during heating.

[0102] <Experimental Example 4: Manufacturing of General Organ Models> In the manufacture of general organ models, a main base material with a primary color was produced by setting the mass ratio of thermoplastic elastomer to oil to approximately 1:1.7 to 1:3.3 and adding a pigment of the primary color. Additionally, an auxiliary base material with an auxiliary color was produced by setting the mass ratio of thermoplastic elastomer to oil to approximately 1:1.7 to 1:3.3 and adding a pigment of a different auxiliary color. To reproduce the appearance of general organs, multiple auxiliary base materials of different colors were manufactured. Block-shaped auxiliary base materials were shaved down to be smaller than the main base material. Next, the block-shaped main base material was molded into the desired organ shape. Multiple auxiliary base materials were unevenly applied to the surface of the molded organ shape to reproduce the appearance of general organs. Finally, by heating at 200°C, the main base material and auxiliary base materials fused together to obtain a general organ model. To mold the organ shape, a mold was used to create the rough shape, and then the finer details were formed during heating.

[0103] The surface of the obtained organ model was confirmed to have the texture of the organ reproduced 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, forming a non-uniform color pattern. Similarly, it was confirmed that a non-uniform color pattern was 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: Manufacturing of Tendon / Connective Tissue Models> In the production of tendon and connective tissue models, the basic material was prepared without adding pigments, by setting the mass ratio of thermoplastic elastomer to oil to approximately 1:1.7 to 1:5. Approximately 0.01 to 0.1 parts by mass of decolorized gampi fibers were added to 100 parts by mass of the basic material, and the mixture was heated to 160°C and molded to obtain tendon and connective tissue models.

[0105] <Experimental Example 6: Manufacturing of a calcified tissue model> Unlike previous experimental examples, the calcified tissue model was prepared by adding hard particles obtained by crushing eggshells to a thermoplastic elastomer instead of adding pigments, then heating 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 unevenly crushed to a particle size of approximately 0.3 mm to 1 mm.

[0106] <Experimental Example 7: Manufacturing of a composite model> A composite model was created by bringing a manufactured fat model and a general organ model into contact and heating the contact area with a soldering iron or heat gun, thereby fusing the fat model and the organ model together. It was confirmed that the longer the heating time, the stronger the adhesion between the fat model and the organ model. Similarly, we confirmed that tendon tissue models, connective tissue models, and calcified tissue models can be heat-fused and adhered to other tissue or organ models.

Claims

1. It comprises a composite structure containing multiple parts that are fused together, Each of the aforementioned components contains a thermoplastic elastomer and oil, and has a different color from one another. Tissue model or organ model.

2. The aforementioned multiple components fuse together to form an irregular color pattern. The tissue model or organ model according to claim 1.

3. The aforementioned multiple parts are mixed together and integrated in three dimensions. The tissue model or organ model according to claim 1 or 2.

4. The aforementioned complex mimics adipose tissue, The tissue model or organ model according to claim 1 or 2.

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

6. Each of the aforementioned plurality of parts contains 100 parts by mass of the thermoplastic elastomer and 100 to 1500 parts by mass of the oil. The tissue model or organ model according to claim 1 or 2.

7. 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. The tissue model or organ model according to claim 1 or 2.

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

9. The system further includes a tendon tissue model that mimics tendon tissue or a connective tissue model that mimics connective tissue, The aforementioned tendon tissue model or connective tissue model includes a fibrous material. The tissue model or organ model according to claim 1 or 2.

10. It also includes a calcified tissue model that mimics calcified tissue, The aforementioned calcified tissue model contains hard particles, The tissue model or organ model according to claim 1 or 2.

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

12. A method for manufacturing tissue models or organ models, A first material preparation step involves preparing a first material comprising a thermoplastic elastomer and an oil, and having a first color. A second material preparation step involves preparing a second material comprising a thermoplastic elastomer and an oil, and having a second color different from the first color, A fusion step in which at least the first material and the second material are fused together while being heated, A method that includes this.

13. At least one of the first material preparation step and the second material preparation step includes heating and mixing the thermoplastic elastomer and the oil, and then cooling them. The method according to claim 12.

14. A method for generating a dataset, A step of obtaining an image of a simulated surgery using a tissue model or organ model as described in claim 1 or 2, and surgical information relating to the simulated surgery associated with the image, The steps include generating a dataset for surgical training by associating the aforementioned images with the aforementioned surgical information, A method for generating a dataset, including [specific data points].

15. A trained model for surgery or surgical assistance, The system is trained using images of a simulated surgery performed using a tissue model or organ model as described in claim 1 or 2, and surgical information relating to the simulated surgery associated with the images. A trained model, when executed by a computer processor, causes the processor to control the computer or surgical instruments connected to the computer and perform the following steps (a) or (b): (a) A step of causing the surgical instrument to perform surgery autonomously or in cooperation with other instruments or a human; (a) A step of causing the computer or surgical instrument to assist in performing the surgery.

Images