JP2018060232A - Three-dimensional entity model and method for manufacturing the model - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a three-dimensional entity model that can conduct a surgery simulation similar to a surgery of a site of an actual human body.SOLUTION: The three-dimensional entity model 10A includes: a surface layer 1A, made of an elastic material; a lower surface 2A, located next to the surface layer and made of an elastic material with an elastic modulus different from that of the elastic material of the surface layer.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a three-dimensional entity model, in particular, a three-dimensional entity model useful for surgical simulation, and a manufacturing method thereof.

  The three-dimensional entity model is a medical shaped object to which the shape of a human body part such as a breast and an organ is added, and is useful for a surgical simulation. Surgery simulation refers to simulated surgery performed for the purpose of practicing a doctor's surgery, planning an operation plan, and explaining the operation to a patient.

  Since the conventional three-dimensional substance model is manufactured from only one kind of material, the elastic modulus is uniform as a whole. The elastic modulus of the 3D model was relatively higher than that of the actual human body part.

  However, even if a conventional three-dimensional entity model is used, a sufficient surgical simulation cannot be performed. Specifically, the following problems occurred.

  (1) In the conventional three-dimensional model, the feel when incising with a scalpel and the feel when suturing the incision are completely different from the actual human body part. For this reason, the operation simulation using the three-dimensional entity model does not sufficiently contribute to the improvement of the doctor's surgical skill. In particular, when the incision portion is sutured in the three-dimensional entity model, the suture portion is easily cut by the suture as compared with the case where the actual human body part is sutured.

  (2) The human body part having elasticity and flexibility has a shape that hangs down in the direction of gravity at the time of surgery, but the conventional three-dimensional entity model is difficult to hang down. The shape at the time of surgery was completely different. Specifically, when a person is laid on the bed during surgery, for example, the actual breast hangs down in the direction of gravity from the side, but the conventional three-dimensional entity model with a breast shape hangs down in the direction of gravity too much. I did not. For this reason, the surgical simulation using the conventional three-dimensional entity model still does not sufficiently contribute to the improvement of the doctor's surgical skill.

  (3) An appropriate removal volume for removing a lesion by surgery in an organ (particularly a breast) and an appropriate filling volume for filling a material such as silicone or autologous tissue into the removed site are the conventional three-dimensional entities. The model and the actual human body part differed greatly. For this reason, an actual operation cannot always proceed according to an operation plan designed using a three-dimensional entity model.

  An object of the present invention is to provide a three-dimensional entity model that can perform a surgical simulation that closely approximates a surgical operation on an actual human body part.

In particular, an object of the present invention is to provide a three-dimensional entity model whose feel is close to that of an actual human body part.
Another object of the present invention is to provide a three-dimensional entity model that can sufficiently contribute to a doctor's surgical practice.
Another object of the present invention is to provide a three-dimensional entity model that can make an operation plan that is well suited to an actual operation.

  In the present specification, the “feel” mainly means a tactile sensation based on elasticity and softness felt when pressing with a hand (finger) from the surface toward the inside.

The present invention
A surface layer made of an elastic material; and a lower layer made of an elastic material arranged adjacent to the surface layer and having an elastic modulus different from that of the elastic material constituting the surface layer;
This relates to a three-dimensional entity model.

By using the three-dimensional entity model of the present invention, it is possible to perform a surgery simulation that closely approximates surgery in an actual human body part.
Specifically, the three-dimensional entity model of the present invention has a feel that closely approximates an actual human body part, and can sufficiently contribute to a doctor's surgical practice. Further, by using the three-dimensional entity model of the present invention, it is possible to devise an operation plan that is well suited to an actual operation. Furthermore, by performing a simulated operation using the three-dimensional entity model of the present invention, the degree of deformation after the operation can be known.

(A) is the schematic which shows the whole shape of an example (left breast model) of an example model of this invention, (B) is an example of a schematic sectional drawing when the PP cross section of (A) is seen in the arrow direction. Yes, (C) is another example of a schematic cross-sectional view when the PP cross section of (A) is viewed in the direction of the arrow. (A) is the schematic which shows the whole shape of an example (liver model) of an example model of this invention, (B) is a schematic sectional drawing when the PP cross section of (A) is seen in the arrow direction. (A) is the schematic which shows the whole shape of an example (lip model) of an actual model of this invention, (B) is a schematic sectional drawing when PP section of the lower lip of (A) is seen in the arrow direction. is there. It is a schematic sectional drawing of an example (skin structure model) of the entity model of this invention. (A) is the schematic which shows the whole shape of an example (outer nose model) of an entity model of this invention, (B) is a schematic sectional drawing when the PP cross section of the nose wing part of (A) is seen in the arrow direction. It is. (A) is the schematic which shows the whole shape of the face model containing an example (eyelid model) of an entity model of this invention, (B) is when PP section of the eyelid part of (A) is seen in the arrow direction. It is a schematic sectional drawing. It is a schematic coronal sectional view of an example (brain model) of an actual model of the present invention. (A) is the schematic which shows the whole shape of an example (auricle model) of an example model of this invention, (B) is a schematic sectional drawing when the PP cross section of (A) is seen in the arrow direction. It is a schematic sectional drawing of an example (breast model) of the real model of this invention. It is the schematic which shows the whole shape of an example (face model) of the real model of this invention, Comprising: It is the schematic when it has a skin tumor. It is a schematic sectional drawing of an example (left breast model) of the substantial model of this invention, Comprising: It is a schematic sectional drawing when it has a tumor. It is a schematic sectional drawing of an example (skin structure model) of the actual model of this invention, Comprising: It is a schematic sectional drawing when it has a skin tumor. It is a schematic sectional drawing which shows an example of the manufacturing method of the real model of this invention. It is a general | schematic sketch of the salt form used in another example of the manufacturing method of the real model of this invention.

[Substance model]
The three-dimensional entity model of the present invention (hereinafter simply referred to as “entity model”) is a medically shaped object used for surgical simulation. Surgery simulation is a simulated operation performed for the purpose of practicing surgery for improving the skill level of a doctor, making an operation plan for smoothly performing the operation, and explaining the operation to a patient.

  The substantial model of the present invention is given a shape equivalent to a human body part. The shape equivalent to the human body part is a shape that allows a third party to recognize the human body part when looking at the appearance of the entity model. The shape of the real model of the present invention may be the shape of any human body part having elasticity and flexibility. Specific shapes include, for example, the whole shape or a partial shape of a breast, an organ (particularly a built-in), a lip, an outer nose, an eyelid, an auricle, a face, and other skin structures. Examples of organs (particularly internal) include heart, liver, pancreas, spleen, kidney and brain. The entity model of the present invention as a whole can also be referred to as an “entity soft model” in the sense that it has the elasticity and softness of such a human body part.

  The entity model of the present invention includes a surface layer and a lower layer disposed adjacent to the surface layer. The surface layer and the lower layer may be inseparably integrated to constitute an elastic body, or may be adjacent to each other so as to be separable from each other. The actual model of the present invention may be a two-layer model consisting of only a surface layer and a lower layer, or three layers including a surface layer, a lower layer, and a deep layer disposed on the side opposite to the surface layer side of the lower layer. It may be a layered model.

  The surface layer is made of an elastic material, for example, an organic elastic material. A polymer is mentioned as an organic type elastic material which comprises a surface layer. Specific examples of the polymer include silicone rubber, isoprene rubber, butadiene rubber, styrene / butadiene rubber, chloroprene rubber, nitrile rubber, polyisobutylene (butyl rubber), ethylene propylene rubber, epichlorohydrin rubber, urethane rubber, gelatin and the like. A preferred surface layer is made of silicone rubber or urethane rubber from the viewpoint of further approximating the feeling between the real model of the present invention and the actual human body part. In this specification, the elastic material refers to a material having elasticity that a human body part can have.

  As the silicone rubber, any silicone rubber conventionally used in the field of the real model and the field of the mold master material can be used. The material for the mold master is a material for the mold master when a replica is made of polyester resin, urethane resin, epoxy resin, wax, gypsum, low melting point alloy or the like. Silicone rubber has a repeating siloxane bond as the main chain, and the side group is a hydrogen atom, an alkyl group (eg, methyl group, ethyl group), an aryl group (eg, phenyl group), an alkenyl group (eg, vinyl group, allyl group). ), An alkoxy group (for example, methoxy group, ethoxy group), and a polymer having an organic group selected from the group consisting of chlorine atoms, and is usually crosslinked (cured).

  Silicone rubber is commercially available. Examples of commercially available silicone rubber include KE-1308 (manufactured by Shin-Etsu Chemical Co., Ltd.).

  As the urethane rubber, any urethane rubber conventionally used in the real model field can be used. Urethane rubber is a prepolymer obtained, for example, by a polyaddition reaction of polyether diol and / or polyester diol and diisocyanate, and is usually crosslinked (cured) with a polyisocyanate compound, polyamine and / or polyol, etc. .

  Urethane rubber is commercially available. Examples of commercially available urethane rubber include Takeflex BRUSH (manufactured by Takebayashi Chemical Industry Co., Ltd.).

  Gelatin is a derived protein obtained by hydrolyzing collagen present in the white connective tissue of vertebrates. As the gelatin, any gelatin widely used in the food industry and the photographic industry, particularly the food industry can be used, and it may be a heterogeneous substance having a molecular weight of 15,000 to 250,000.

  Any gelatin that is available as a commercial edible product can be used.

  The polymer constituting the surface layer is not particularly limited as long as a predetermined elastic modulus described later can be achieved.

  The surface layer may contain additives such as a curing agent (crosslinking agent), a colorant and a solvent in addition to the elastic material. Specifically, in the case where the surface layer is composed of a polymer other than gelatin among the above polymers, the surface layer usually contains a polymer other than the gelatin and a hardener, and may further contain a colorant. When the surface layer is composed of gelatin, the surface layer usually contains the gelatin and a solvent, and may further contain a colorant.

  The hardener is an additive for crosslinking the elastic material, and is contained when the contained layer is composed of a polymer other than gelatin. Any curing agent can be used as the curing agent depending on the type of elastic material. For example, when a polymer (for example, silicone rubber) is used as the elastic material, any curing agent known in the polymer (for example, silicone rubber) field can be used as the curing agent. As a specific example of the silicone rubber curing agent, for example, CAT-1300L-4 (manufactured by Shin-Etsu Chemical Co., Ltd.) can be used. As specific examples of urethane rubber curing agents, for example, polyisocyanate compounds, polyamines and / or polyols can be used.

The content of the curing agent in the surface layer may be an amount that closely approximates the feel of the actual model of the present invention and the feel of the actual human body part, and is usually 40% by weight or less based on the elastic material. Or it is 300 weight% or less.
When the surface layer is made of an elastic material made of a polymer other than the above-described polymers, particularly urethane rubber and gelatin, the lower limit of the content of the hardener in the surface layer is, for example, 0.1% by weight relative to the elastic material It may be 1% by weight or 2% by weight. In the same case, the upper limit of the content may be, for example, 40% by weight, 30% by weight, 20% by weight, or 15% by weight with respect to the elastic material. % Or 10% by weight.

  When the surface layer is made of, for example, urethane rubber, the lower limit of the content of the curing agent in the surface layer may be, for example, 0.1% by weight or 1% by weight with respect to the elastic material. It may be 10% by weight or 20% by weight. In the same case, the upper limit of the content may be, for example, 300% by weight, 200% by weight, 100% by weight, or 50% with respect to the elastic material. It may be weight percent.

  The elastic modulus of the surface layer can be controlled by adjusting the content of the curing agent in the surface layer. The higher the content of the curing agent, the higher the elastic modulus generally, and the lower the content, the lower the elastic modulus generally. The surface layer may contain a salt (NaCl), and the elastic modulus can be increased by containing the salt. When the surface layer is made of gelatin, the content of the hardener in the surface layer is usually 0% by weight.

  The colorant contained in the surface layer is an additive added for the purpose of coloring the entity model so that the entity model has a color equivalent to that of a human body part or so that the suture can be seen well. For example, known pigments and dyes are used. The content of the colorant may be an amount that achieves the above object.

  A solvent is contained when the contained layer is composed of gelatin. The solvent is not particularly limited as long as gelatin is a soluble liquid, and examples thereof include water; and organic solvents such as acetic acid, trifluoroethanol, formamide, ethylene glycol, and dimethyl sulfoxide. Preferably it is water. The content of the solvent in the surface layer may be an amount that closely approximates the feel of the real model of the present invention and the feel of the actual human body part, and is usually 40% by weight or less with respect to gelatin. . When the surface layer is made of gelatin as an elastic material, the lower limit of the solvent content of the surface layer may be, for example, 2% by weight or 3% by weight with respect to gelatin. Alternatively, it may be 8% by weight. In the same case, the upper limit value of the content may be, for example, 30% by weight, 20% by weight, or 15% by weight with respect to the elastic material. When the surface layer is made of gelatin, the elastic modulus of the surface layer can be controlled by adjusting the content of the solvent (for example, water) in the surface layer. The higher the content of the solvent, the lower the elastic modulus generally, and the lower the content, the higher the elastic modulus generally. When the surface layer is made of an elastic material made of a polymer other than gelatin among the above polymers, the content of the solvent in the surface layer is usually 0% by weight.

  The thickness of the surface layer may be appropriately selected according to the type of human body part that the actual model of the present invention mimics the touch, and is, for example, 0.1 to 30 mm, particularly 0.3 to 15 mm. Good.

  The lower layer is a layer positioned on the deep layer side relative to the surface layer when the entity model of the present invention is viewed as a human body part.

  The lower layer is made of an elastic material having an elastic modulus different from that of the elastic material constituting the surface layer. For example, the lower layer is made of an organic elastic material. Specific examples of the organic elastic material constituting the lower layer include similar organic elastic materials (particularly polymers) and silicone gels exemplified as the organic elastic material constituting the surface layer. The lower layer preferable from the viewpoint of further approximation of the feeling between the real model of the present invention and the actual human body part may be composed of the same type of organic elastic material as the organic elastic material constituting the surface layer. Alternatively, it may be composed of urethane rubber, silicone rubber, silicone gel or gelatin. From the same viewpoint, a more preferred lower layer is composed of silicone rubber, silicone gel or gelatin. Specifically, for example, when the surface layer is composed of silicone rubber, the lower layer is preferably composed of silicone rubber, silicone gel, or gelatin. For example, when the surface layer is made of urethane rubber, the lower layer is preferably made of silicone rubber, silicone gel or gelatin.

The degree of adhesion between the lower layer and the surface layer depends on the affinity of the materials constituting these layers.
For example, when the lower layer is composed of the same type of organic elastic material as the organic elastic material constituting the surface layer, the same type of material is highly compatible with each other, so the surface layer is usually inseparable from the lower layer. It is integrated. When the surface layer is inseparably integrated with the lower layer, it means that even if the surface layer is peeled off from the lower layer by human power, peeling at the interface between them is difficult.
In addition, for example, when the combination of the constituent material of the lower layer and the constituent material of the surface layer is a combination of silicone rubber and urethane rubber, the surface layer can be separated from the lower layer when the combination has low affinity to each other. It is integrated. The surface layer is integrated so that it can be detached from the lower layer. Before the surgical simulation, the surface layer surrounds at least a part of the lower surface, and both are integrated. Is a state in which the surface layer can be easily peeled from the lower layer from the cut. In such a case, since the surface layer can be easily replaced many times, the real model of the present invention is economical.

As the silicone rubber constituting the lower layer, the same commercially available products as exemplified as the commercially available silicone rubber constituting the surface layer can be used.
As the urethane rubber constituting the lower layer, the same commercially available products exemplified as the commercially available urethane rubber constituting the surface layer can be used.
As the gelatin constituting the lower layer, commercially available products similar to the gelatin constituting the surface layer can be used.
The silicone gel constituting the lower layer is available as a commercial product. Examples of commercially available silicone gels include Wacker SilGel 612A (Asahi Kasei Wacker Silicone) and Wacker Silgel 612B (Asahi Kasei Silicone).

  Similarly to the surface layer, the lower layer may also contain additives such as a curing agent, a colorant, a salt and a solvent in addition to the elastic material. Even in the lower layer, the elastic modulus can be increased by containing salt.

  Specifically, when the lower layer is composed of a polymer other than gelatin among the above polymers, the lower layer usually contains a polymer other than the gelatin and a hardener, and may further contain a colorant. When the lower layer is composed of gelatin, the lower layer usually contains the gelatin and a solvent, and may further contain a colorant. When the lower layer is composed of a silicone gel, the lower layer usually contains the silicone gel and a solvent, and may further contain a colorant and / or a curing agent, but usually does not contain a curing agent.

  The types of the curing agent and the solvent contained in the lower layer may be selected from the same range as the types of the curing agent and the solvent contained in the surface layer, respectively.

When the lower layer is composed of a polymer other than silicone gel and gelatin, the content of the lower layer hardener is such that the feel of the real model of the present invention approximates the feel of an actual human body part.
For example, when the lower layer and the surface layer are made of the same type of material other than silicone gel and gelatin, the content of the hardener in the lower layer is usually different from the content of the hardener in the surface layer. In this case, specifically, the content of the curing agent in the lower layer is usually in the same range as the content range of the curing agent described above in the description of the surface layer, and is different from the content of the curing agent in the surface layer. is there.

  Also, for example, when the lower layer and the surface layer are materials other than silicone gel and gelatin and are composed of different types of materials, the content of the lower layer curing agent is usually the elastic modulus of the material constituting the lower layer. What is necessary is just to be an amount different from the elastic modulus of the material constituting the layer.

  When the lower layer is composed of a polymer other than silicone gel and gelatin, the elastic modulus of the lower layer can be controlled by adjusting the content of the hardener in the lower layer as in the surface layer.

  When the lower layer is composed of silicone gel and / or gelatin, the content of the lower layer curing agent is usually 0% by weight.

  When the lower layer is composed of silicone gel and / or gelatin, the content of the solvent in the lower layer is such that the feel of the real model of the present invention approximates the feel of the actual human body part.

  When the lower layer is made of gelatin, the content of the lower layer solvent is usually different from the content of the solvent in the surface layer. In this case, specifically, the content of the solvent in the lower layer is usually in the same range as the content range of the solvent described above in the description of the surface layer composed of gelatin, and is different from the content of the solvent in the surface layer. Amount.

  When the lower layer is composed of a silicone gel, the content of the solvent in the lower layer is usually sufficient if the elastic modulus of the material constituting the lower layer is different from the elastic modulus of the material constituting the surface layer.

  When the lower layer is composed of silicone gel and / or gelatin, the elastic modulus of the lower layer can be controlled by adjusting the content of the solvent in the lower layer as in the surface layer. When the lower layer is composed of a polymer other than silicone gel and gelatin, the content of the solvent in the lower layer is usually 0% by weight.

  The kind and content of the colorant contained in the lower layer may be selected from the same range as the kind and content of the colorant contained in the surface layer, respectively.

  The thickness of the lower layer may be appropriately selected according to the type of human body part that the actual model of the present invention mimics the touch.

  Elastic modulus of the elastic material constituting the surface layer (hereinafter simply referred to as “elastic modulus of the surface layer”) and elastic modulus of the elastic material constituting the lower layer (hereinafter simply referred to as “elastic modulus of the lower layer”) ) Is adjusted so that the touch when pressing from the surface of the surface layer toward the lower layer approximates the touch when pressing from the surface of the actual human body part toward the inside. The elastic modulus of the surface layer and the lower layer is, for example, an elastic modulus when pressed from the surface layer surface toward the lower layer (hereinafter, also referred to as “elastic modulus A”) from the surface of the actual human body part to the inside. It is adjusted so as to approximate the elastic modulus when pressed toward (hereinafter, also referred to as “elastic modulus B”). That the elastic modulus A approximates the elastic modulus B means that the elastic modulus A is within a range of −10 to + 10%, preferably −5 to + 5% of the elastic modulus B.

  The magnitude relationship between the elastic modulus of the surface layer and the elastic modulus of the lower layer differs depending on the shape type of the entity model, for example, the elastic modulus of the lower layer may be lower than the elastic modulus of the surface layer, or It may be high.

In this specification, the elastic modulus may be, for example, Young's modulus. In the present specification, the value of the complex elastic modulus is used as the elastic modulus. The complex elastic modulus is a value based on a dynamic viscoelasticity test (frequency dispersion) according to JIS K6394: 2007 “vulcanized rubber and thermoplastic rubber—how to obtain dynamic properties—general guidelines”. Specifically, it can be measured under the following conditions. As the test piece, a cylindrical test piece having a diameter of 3 to 6 mm and a height of 3 to 5 mm is used.
Measurement mode: Compression mode Measurement frequency: 1 Hz
Measurement temperature: 23 ° C
Static strain: 5%
Dynamic strain: 1%
Tester: TA INSTRUMENTS viscoelasticity measuring device RSA-3

  The loss tangent described later can also be measured by the same method as the complex elastic modulus.

  The present invention encompasses the following embodiments X, Y and Z. The surface layers and lower layers of the following embodiments X, Y and X correspond to the above-described surface layers and lower layers, respectively.

<Embodiment X>
In this embodiment X, the elastic modulus of the lower layer is lower than the elastic modulus of the surface layer.
For example, the human body model is selected from the group consisting of breast, organ (especially built-in), lips, outer nose, eyelids, face, and other skin structures (hereinafter sometimes simply referred to as “Group X”). When it has a shape equivalent to the whole shape or a part of the shape in the body part, the elastic modulus of the lower layer is lower than the elastic modulus of the surface layer. In this case, the elastic modulus of the lower layer and the surface layer may be adjusted so that the feel of the real model of this embodiment and the feel of the actual human body part are closely approximated. The elastic modulus of the layer is usually in the range of 1 to 99.9%, particularly 1 to 99%, preferably 1 to 80%, more preferably 1 to 70%. The ratio between the elastic modulus of the lower layer and the elastic modulus of the surface layer is usually from 1: 1.2 to 1: 100, preferably from 1: 1.5 to 1: 100, more preferably from 1: 2 to 1. : 100, more preferably 1: 2 to 1:80, and most preferably 1: 2 to 1:50.

When the entity model has a shape equivalent to a human body part selected from the group X described above, the elastic modulus of the lower layer and the surface layer is usually within the following range:
Lower layer: 0.1 × 10 ^{3 to} 5.0 × 10 ⁵ Pa, preferably 1.0 × 10 ^{3 to} 1.5 × 10 ⁵ Pa, more preferably 5.0 × 10 ^{3 to} 1.2 × 10 ⁵ Pa Pa;
Surface layer: 1.0 × 10 ^{4 to} 1.0 × 10 ⁶ Pa, preferably 5.0 × 10 ^{4 to} 7.0 × 10 ⁵ Pa, more preferably 1.2 × 10 ^{5 to} 4.0 × 10 ⁵ Pa.

The absolute value of the difference between the elastic modulus of the elastic material constituting the lower layer and the elastic material constituting the surface layer is a more approximate approximation of the feel between the real model of the present invention and the actual human body part. terms, is preferably ^{1.0 × 10 4 ~1.0 × 10 6} Pa, more preferably ^{5.0 × 10 4 ~1.0 × 10 6} Pa, 1.0 × 10 5 More preferably, it is -5.0 * 10 < ⁵ > Pa.

If the entity model has a shape equivalent to a human body part selected from group X described above, the loss tangent of the lower and surface layers is usually within the following range:
Lower layer: 0.1-0.9, preferably 0.15-0.85;
Surface layer: 0.1-0.9, preferably 0.1-0.5, more preferably 0.15-0.3.

  In the present embodiment X, the elastic material constituting the surface layer and the lower layer may be independently selected from the above-described range. In this embodiment X, the elastic material constituting the surface layer is silicone rubber or polyurethane rubber from the viewpoint of further approximating the feeling between the real model of the present invention and the actual human body part, and the lower layer is constituted. The elastic material to be used is silicone rubber, silicone gel or gelatin.

  In the embodiment X, the contents of the curing agent and / or solvent in the surface layer and the lower layer may be appropriately set and selected so that the surface layer and the lower layer have the above-described elastic modulus relationship.

  In the present embodiment X, the thickness of the surface layer and the lower layer may be as described above.

  This embodiment X includes the following embodiments x1 to x7. The surface layers and lower layers of the following embodiments x1 to x7 correspond to the above-described surface layers and lower layers, respectively.

(Embodiment x1)
The entity model according to the embodiment x1 has the same shape as the breast (particularly the left breast) in the group X described above. In this embodiment, the real model 10A having the shape of the left breast has an overall shape as shown in FIG. 1A and a cross-sectional structure as shown in FIG. 1B or FIG. . FIG. 1A is a schematic diagram showing the overall shape of the entity model 10A, and FIG. 1B shows an example of a schematic cross-sectional view when the PP cross-section of FIG. 1 (C) shows another example of a schematic cross-sectional view when the PP cross section of FIG. 1 (A) is viewed in the direction of the arrow. In FIG. 1B, the surface layer 1A covers the entire surface of one side of the lower layer 2A, but may cover a part of the surface of the lower layer 2A according to a desired surgical site. In FIG. 1C, the surface layer 1A covers almost the entire surface of the lower layer 2A. In this embodiment, the surface layer 1A corresponds to the skin of the breast (including the epidermis and dermis), and the lower layer 2A corresponds to the subcutaneous tissue of the breast (including mammary gland tissue and fat).

  In the present embodiment, the elastic modulus of the lower layer 2A is in the range of 1 to 99% with respect to the elastic modulus of the surface layer 1A from the viewpoint of further approximation of the feel between the real model and the actual human breast. 1 to 80% is more preferable, 1 to 70% is more preferable, and 1 to 50% is most preferable. The ratio of the elastic modulus of the lower layer and the elastic modulus of the surface layer is usually 1: 1.2 to 1: 100, preferably 1: 1.5 to 1: 100, more preferably 1: 1.5. ˜1: 80, more preferably 1: 2 to 1:50.

In this embodiment, the elastic modulus of the lower layer and the surface layer is usually within the following range:
Lower layer: 0.1 × 10 ^{3 to} 5.0 × 10 ⁵ Pa, preferably 1.0 × 10 ^{3 to} 1.5 × 10 ⁵ Pa, more preferably 5.0 × 10 ^{3 to} 1.2 × 10 ⁵ Pa Pa;
Surface layer: 1.0 × 10 ^{5 to} 1.0 × 10 ⁶ Pa, preferably 2.0 × 10 ^{5 to} 7.0 × 10 ⁵ Pa, more preferably 2.5 × 10 ^{5 to} 4.0 × 10 ⁵ Pa.

The absolute value of the difference between the elastic modulus of the elastic material constituting the lower layer and that of the elastic material constituting the surface layer is a more approximate approximation of the feel of the breast model of this embodiment and the actual human breast. From the viewpoint, it is preferably 5.0 × 10 ^{4 to} 1.0 × 10 ⁶ Pa, more preferably 1.0 × 10 ^{5 to} 1.0 × 10 ⁶ Pa, and 1.0 × 10 ⁵ Pa. More preferably, it is -5.0 * 10 < ⁵ > Pa.

In this embodiment, the loss tangent of the lower layer and the surface layer is usually in the following range:
Lower layer: 0.1-0.9, preferably 0.15-0.85;
Surface layer: 0.1-0.5, preferably 0.1-0.4, more preferably 0.15-0.3.

  The breast model according to the present embodiment includes a non-drooping type (young type) and a drooping type (old age type) from the viewpoint of further approximation of the feeling between the substantial model and the actual human breast.

  In the non-sag type breast model, the elastic modulus of the lower layer 2A is preferably 10 to 99% with respect to the elastic modulus of the surface layer 1A, from the viewpoint of further approximation of the feel between the real model and the actual human breast. It is more preferably 20 to 99%, further preferably 20 to 80%, and most preferably within the range of 20 to 50%. The ratio between the elastic modulus of the lower layer and the elastic modulus of the surface layer is preferably 1: 1.2 to 1:50, more preferably 1: 1.5 to 1:20, and still more preferably 1: 2 to 2. 10.

In the non-pendant breast model, the elastic modulus of the lower and surface layers is usually in the following range:
Lower layer: 1.0 × 10 ^{3 to} 5.0 × 10 ⁵ Pa, preferably 1.0 × 10 ^{4 to} 1.5 × 10 ⁵ Pa, more preferably 5.0 × 10 ^{4 to} 1.5 × 10 ⁵ Pa Pa;
Surface layer: 1.0 × 10 ^{5 to} 1.0 × 10 ⁶ Pa, preferably 2.0 × 10 ^{5 to} 7.0 × 10 ⁵ Pa, more preferably 2.5 × 10 ^{5 to} 4.0 × 10 ⁵ Pa.

In the non-sag type breast model, the absolute value of the difference between the elastic modulus of the elastic material constituting the lower layer and the elastic modulus of the elastic material constituting the surface layer is the difference between the breast model of the present invention and the actual human breast. From the viewpoint of a more approximate feel, it is preferably 5.0 × 10 ^{4 to} 1.0 × 10 ⁶ Pa, more preferably 1.0 × 10 ^{5 to} 1.0 × 10 ⁶ Pa. 1.0 × 10 ^{5 to} 5.0 × 10 ⁵ Pa is more preferable.

In non-droop breast models, the loss tangent of the lower and surface layers is usually within the following range:
Lower layer: 0.1-0.5, preferably 0.1-0.4, more preferably 0.15-0.3;
Surface layer: 0.1-0.5, preferably 0.1-0.4, more preferably 0.15-0.3.

  In the drooping breast model, the elastic modulus of the lower layer 2A is preferably 1 to 50% with respect to the elastic modulus of the surface layer 1A from the viewpoint of further approximating the touch between the real model and the actual human breast. -19% is more preferable, 1-10% is more preferable, and it is most preferable that it exists in the range of 1-5%. The ratio between the elastic modulus of the lower layer and the elastic modulus of the surface layer is preferably 1: 5 to 1: 100, more preferably 1:10 to 1: 100, still more preferably 1:10 to 1:80. Yes, most preferably from 1:15 to 1:50.

In the pendulous breast model, the elastic modulus of the lower and surface layers is usually in the following range:
^{Lower: 0.1 × 10 3 ~1.0 × 10} 5 Pa, preferably ^{1.0 × 10 3 ~5.0 × 10 4} Pa, more preferably 5.0 × ¹⁰ 3 ~5.0 × ^{10 4} Pa;
Surface layer: 1.0 × 10 ^{5 to} 1.0 × 10 ⁶ Pa, preferably 2.0 × 10 ^{5 to} 7.0 × 10 ⁵ Pa, more preferably 2.5 × 10 ^{5 to} 4.0 × 10 ⁵ Pa.

In the drooping breast model, the absolute value of the difference between the elastic modulus of the elastic material constituting the lower layer and the elastic modulus of the elastic material constituting the surface layer is the touch between the breast model of the present invention and the actual human breast. From the viewpoint of further approximation, it is preferably 5.0 × 10 ^{4 to} 1.0 × 10 ⁶ Pa, more preferably 1.0 × 10 ^{5 to} 1.0 × 10 ⁶ Pa, further preferably ^{1.0 × 10 5 ~5.0 × 10 5} Pa.

In the drooping breast model, the loss tangent of the lower and surface layers is usually within the following range:
Lower layer: 0.1-0.9, preferably 0.5-0.9, more preferably 0.6-0.9;
Surface layer: 0.1-0.5, preferably 0.1-0.4, more preferably 0.15-0.3.

  In the real model of this embodiment, the volume ratio of the surface layer 1A to the lower layer 2A is usually 0.1: 99.9 to 50:50, particularly 1:99 to 50:50. From the viewpoint of further approximation of the actual feeling with the breast, it is preferably 1:99 to 30:70, more preferably 1:99 to 20:80, and further preferably 1:99 to 10:90. It is.

In the present embodiment, the thicknesses of the lower layer 2A and the surface layer 1A are usually within the following ranges, respectively:
Lower layer 2A thickness t _2A : 10 to 150 mm;
Surface layer 1A of the thickness _t 1A: 0.3 to 10 mm, preferably 0.3 to 5 mm, more preferably 0.3 to 2 mm.
In the present specification, a numerical range for thickness means that the thickness may vary within the numerical range.

  In the breast model of this embodiment, the surface layer and the lower layer may each be composed of the elastic material described above, but preferably the surface layer is composed of silicone rubber or urethane rubber, and the lower layer is composed of gelatin, silicone gel, or silicone rubber. Composed. More preferably, the surface layer is made of silicone rubber or urethane rubber, and the lower layer is made of gelatin or silicone gel.

  In this embodiment, the lower layer 2A is preferably supported by a curved support 3A as shown in FIG. The curved support 3A corresponds to the chest wall located between the actual breast and lung. The chest wall is composed of ribs and intercostal muscles, and the curved support 3A has a curved shape equivalent to the chest wall. In FIG. 1 (B), in order to show the left breast, the curve descends toward the right side on the drawing corresponding to the left side. Since the breast model 10A of the present embodiment has the curved support 3A below the lower layer 2A, it becomes easy to have a drooping shape in the weight direction as much as the actual breast. A more approximate surgical simulation can be performed. The curved support 3A may be made of any material as long as it has a hardness and strength sufficient to support the lower layer 2A and the surface layer 1A disposed thereon. Examples of the constituent material of the curved support 3A include silicone rubber, gypsum, plastic, and metal.

  In FIG. 1B, a cavity is formed between the curved support 3A and the bottom of the mold 5A, but the cavity may be filled with a filler such as silicone rubber, gypsum, or plastic. Alternatively, the curved support 3A may be used as the bottom of the mold without using the bottom of the mold 5A.

The breast model 10A preferably has a mold 5A as shown in FIG. 1B from the viewpoint of shape retention, but it does not necessarily have to be.
In the breast model 10A, it is preferable that the surface layer 1A covers almost the entire surface of the lower layer 2A as shown in FIG.

(Embodiment x2)
The entity model according to the embodiment x2 has a shape equivalent to an organ, particularly the liver, of the group X described above. In this embodiment, the real model 10B having the shape of a liver has an overall shape as shown in FIG. 2A, and has a cross-sectional structure as shown in FIG. 2A is a schematic diagram showing the overall shape of the entity model 10B, and FIG. 2B is a schematic cross-sectional view of the PP cross section of FIG. 2A viewed in the direction of the arrow. 2A and 2B, the surface layer 1B covers the entire surface of the lower layer 2B, but may cover a part of the surface of the lower layer 2B according to a desired surgical site. In this embodiment, the surface layer 1B corresponds to the liver coating, and the lower layer 2B corresponds to the liver parenchyma.

  In the present embodiment, the elastic modulus of the lower layer 2B is 1 to 99% of the elastic modulus of the surface layer 1B from the viewpoint of a more approximate feel of the real model and the actual human organ (particularly the liver). In particular, it is preferably in the range of 20 to 99%. The ratio between the elastic modulus of the lower layer and the elastic modulus of the surface layer is preferably 1: 5 to 1: 100, more preferably 1:10 to 1: 100.

In this embodiment, the elastic modulus of the lower layer and the surface layer is usually within the following range:
Lower layer: 0.1 × 10 ^{3 to} 5.0 × 10 ⁵ Pa, preferably 1.0 × 10 ^{3 to} 1.5 × 10 ⁵ Pa, more preferably 5.0 × 10 ^{3 to} 1.2 × 10 ⁵ Pa Pa;
Surface layer: 1.0 × 10 ^{5 to} 1.0 × 10 ⁶ Pa, preferably 2.0 × 10 ^{5 to} 7.0 × 10 ⁵ Pa, more preferably 2.5 × 10 ^{5 to} 4.0 × 10 ⁵ Pa.

The absolute value of the difference between the elastic modulus of the elastic material constituting the lower layer and the elastic material constituting the surface layer is a more approximate approximation of the feel between the organ model of this embodiment and the actual human organ. From the viewpoint, it is preferably 5.0 × 10 ^{4 to} 1.0 × 10 ⁶ Pa, more preferably 1.0 × 10 ^{5 to} 1.0 × 10 ⁶ Pa, and 1.0 × 10 ⁵ Pa. More preferably, it is -5.0 * 10 < ⁵ > Pa.

In this embodiment, the loss tangent of the lower layer and the surface layer is usually in the following range:
Lower layer: 0.1-0.9, preferably 0.15-0.85;
Surface layer: 0.1-0.5, preferably 0.1-0.4, more preferably 0.15-0.3.

In the present embodiment, the thickness of the surface layer 1B is usually within the following range:
The thickness _t 1B of the surface layer 1B: 0.3 to 2 mm.
The thickness of the lower layer 2B, as long as the overall thickness T _B is comparable to the actual human liver is not particularly limited.

  In the organ model of this embodiment, the surface layer and the lower layer may each be composed of the elastic material described above, but preferably the surface layer is composed of silicone rubber or urethane rubber, and the lower layer is gelatin, silicone gel, urethane rubber or Consists of silicone rubber. More preferably, the surface layer is made of silicone rubber and the lower layer is made of gelatin.

(Embodiment x3)
The entity model according to the embodiment x3 has a shape equivalent to the lips, particularly the lower lips, of the group X described above. The entity model 10C of this embodiment has the entire shape of the lips as shown in FIG. 3A, and the lower lip has a cross-sectional structure as shown in FIG. FIG. 3A is a schematic diagram of an example of a substantial model of the present embodiment having the entire shape of the lips, and FIG. 3B is a PP cross section in the lower lip of the lips of FIG. A schematic cross-sectional view when viewed is shown. 3A and 3B, the surface layer 1C covers the entire surface of the lower layer 2C, but may cover a part of the surface of the lower layer 2C according to a desired surgical site. In this embodiment, the surface layer 1C corresponds to the skin of the lips (including the epidermis and dermis), and the lower layer 2C corresponds to the subcutaneous tissue of the lips (including the muscle layer and fat).

  In the present embodiment, the elastic modulus of the lower layer 2C is in the range of 10 to 80% with respect to the elastic modulus of the surface layer 1C from the viewpoint of further approximation of the feel between the real model and the actual human lip. It is preferably 10 to 70%, more preferably 10 to 50%. The ratio between the elastic modulus of the lower layer and the elastic modulus of the surface layer is preferably 1: 1.5 to 1:10, more preferably 1: 2 to 1:10, still more preferably 1: 2 to 1: 1. 5.

In this embodiment, the elastic modulus of the lower layer and the surface layer is usually within the following range:
Lower layer: 1.0 × 10 ^{3 to} 5.0 × 10 ⁵ Pa, preferably 5.0 × 10 ^{3 to} 1.5 × 10 ⁵ Pa, more preferably 1.0 × 10 ^{4 to} 1.2 × 10 ⁵ Pa Pa;
Surface layer: 1.0 × 10 ^{5 to} 1.0 × 10 ⁶ Pa, preferably 2.0 × 10 ^{5 to} 7.0 × 10 ⁵ Pa, more preferably 2.0 × 10 ^{5 to} 4.0 × 10 ⁵ Pa.

The absolute value of the difference between the elastic modulus of the elastic material composing the lower layer and the elastic material composing the surface layer is a more approximate approximation of the feel between the lip model of this embodiment and the actual human lip. From the viewpoint, it is preferably 5.0 × 10 ^{4 to} 1.0 × 10 ⁶ Pa, more preferably 1.0 × 10 ^{5 to} 1.0 × 10 ⁶ Pa, and 1.0 × 10 ⁵ Pa. More preferably, it is -5.0 * 10 < ⁵ > Pa.

In this embodiment, the loss tangent of the lower layer and the surface layer is usually in the following range:
Lower layer: 0.1-0.5, preferably 0.1-0.4, more preferably 0.15-0.3;
Surface layer: 0.1-0.5, preferably 0.1-0.4, more preferably 0.15-0.3.

In this embodiment, the thickness of the surface layer 1C is usually in the following range:
The thickness of the surface layer 1C _t 1C: 0.3~3mm.
The thickness of the lower layer 2C as long as the overall thickness T _C is comparable to the entire thickness of the actual lower lip of a human is not particularly limited.

  In the lip model of this embodiment, the surface layer and the lower layer may each be made of the elastic material described above, but preferably the surface layer is made of silicone rubber or urethane rubber, and the lower layer is made of gelatin or silicone rubber. . More preferably, the surface layer is made of silicone rubber or urethane rubber, and the lower layer is made of silicone rubber.

  In this embodiment, the shape of the cleft lip can be imparted to the surface layer and the lower layer.

(Embodiment x4)
The entity model according to the embodiment x4 has a shape equivalent to a skin structure composed of skin and subcutaneous tissue in the group X described above. The entity model 10D of this embodiment has a skin structure shape, and has a cross-sectional structure as shown in FIG. In the real model 10D of FIG. 4, the surface layer 1D covers the entire surface of one side of the lower layer 2D, but may cover a part of the surface of the lower layer 2D according to a desired surgical site. In this embodiment, the surface layer 1D corresponds to the skin (including the epidermis and dermis) of the skin structure, and the lower layer 2D corresponds to the subcutaneous tissue (including the muscle layer and fat) of the skin structure.

  In the present embodiment, the elastic modulus of the lower layer 2D is 10% to 80%, particularly 10% with respect to the elastic modulus of the surface layer 1D from the viewpoint of further approximation of the touch between the substantial model and the actual human skin structure. It is preferable to be within a range of ˜70%. The ratio between the elastic modulus of the lower layer and the elastic modulus of the surface layer is preferably 1: 2 to 1:10, more preferably 1: 3 to 1: 5.

In this embodiment, the elastic modulus of the lower layer and the surface layer is usually within the following range:
Lower layer: 1.0 × 10 ^{3 to} 2.0 × 10 ⁵ Pa, preferably 5.0 × 10 ^{3 to} 1.5 × 10 ⁵ Pa, more preferably 1.0 × 10 ^{4 to} 1.2 × 10 ⁵ Pa Pa;
Surface layer: 1.0 × 10 ^{5 to} 1.0 × 10 ⁶ Pa, preferably 2.0 × 10 ^{5 to} 7.0 × 10 ⁵ Pa, more preferably 2.0 × 10 ^{5 to} 4.0 × 10 ⁵ Pa.

The absolute value of the difference between the elastic modulus of the elastic material constituting the lower layer and that of the elastic material constituting the surface layer is determined by the feel of the skin structure model of this embodiment and the actual human skin structure. From the viewpoint of further approximation, it is preferably 5.0 × 10 ^{4 to} 1.0 × 10 ⁶ Pa, more preferably 1.0 × 10 ^{5 to} 1.0 × 10 ⁶ Pa. further preferably ^{0 × 10 5 ~5.0 × 10 5} Pa.

In this embodiment, the loss tangent of the lower layer and the surface layer is usually in the following range:
Lower layer: 0.1-0.5, preferably 0.1-0.4, more preferably 0.15-0.3;
Surface layer: 0.1-0.5, preferably 0.1-0.4, more preferably 0.15-0.3.

In this embodiment, the thicknesses of the lower layer 2D and the surface layer 1D are usually within the following ranges, respectively:
Lower layer 2D thickness t _2D : _{2 to} 60 mm;
The thickness of the surface layer 1D _t 1D: 0.3~3mm.

  In the skin structure model of this embodiment, the surface layer and the lower layer may each be made of the elastic material described above, but preferably the surface layer is made of silicone rubber and the lower layer is made of gelatin or silicone rubber. More preferably, the surface layer is made of silicone rubber and the lower layer is made of gelatin.

(Embodiment x5)
The entity model according to the embodiment x5 has the same shape as the outer nose in the group X described above. The entity model 10E of this embodiment has the entire shape of the outer nose as shown in FIG. 5A, and the nose wing has a cross-sectional structure as shown in FIG. FIG. 5A is a schematic diagram of an example of a substantial model of the present embodiment having the entire shape of the outer nose, and FIG. 5B is a PP cross section of the nasal wing of the outer nose of FIG. The schematic sectional drawing when it sees in is shown. 5A and 5B, the surface layer 1E covers the entire surface of the lower layer 2E, but may cover a part of the surface of the lower layer 2E according to a desired surgical site. In this embodiment, the surface layer 1E corresponds to the skin of the outer nose (including the epidermis and dermis), and the lower layer 2E corresponds to the subcutaneous tissue (including the muscle layer, cartilage and fat) of the outer nose.

  In the present embodiment, the elastic modulus of the lower layer 2E is within the range of 10 to 80% with respect to the elastic modulus of the surface layer 1E from the viewpoint of a further approximation of the feeling between the real model and the actual human outer nose. It is preferably 10 to 70%, more preferably 30 to 60%. The ratio between the elastic modulus of the lower layer and the elastic modulus of the surface layer is preferably 1: 1.5 to 1:10, more preferably 1: 1.5 to 1:10, more preferably 1: 2. ~ 1: 5.

In this embodiment, the elastic modulus of the lower layer and the surface layer is usually within the following range:
Lower layer: 1.0 × 10 ^{3 to} 2.0 × 10 ⁵ Pa, preferably 5.0 × 10 ^{3 to} 1.5 × 10 ⁵ Pa, more preferably 5.0 × 10 ^{4 to} 1.2 × 10 ⁵ Pa Pa;
Surface layer: 0.5 × 10 ^{5 to} 0.5 × 10 ⁶ Pa, preferably 1.0 × 10 ^{5 to} 5.0 × 10 ⁵ Pa, more preferably 1.0 × 10 ^{5 to} 3.0 × 10 ⁵ Pa.

The absolute value of the difference between the elastic modulus of the elastic material that constitutes the lower layer and the elastic modulus of the elastic material that constitutes the surface layer is a further increase in the feel of the external nose model of this embodiment and the actual external nose of the human. from the viewpoint of approximation, preferably from ^{1.0 × 10 4 ~5.0 × 10 5} Pa, more preferably ^{1.0 × 10 4 ~3.0 × 10 5} Pa, 5.0 × More preferably, it is 10 ^{4 to} 2.0 × 10 ⁵ Pa.

In this embodiment, the loss tangent of the lower layer and the surface layer is usually in the following range:
Lower layer: 0.1-0.5, preferably 0.1-0.4, more preferably 0.15-0.3;
Surface layer: 0.1-0.5, preferably 0.1-0.4, more preferably 0.15-0.3.

In this embodiment, the thickness of the surface layer 1E is usually in the following range:
The thickness of the surface layer 1E _t 1E: 0.3~2mm.
The thickness of the lower layer 2E so long as the overall thickness T _E is the actual thickness approximately the same outside the human nose is not particularly limited.

  In the outer nose model of this embodiment, each of the surface layer and the lower layer may be made of the elastic material described above. Preferably, the surface layer is made of silicone rubber, and the lower layer is made of gelatin or silicone rubber. More preferably, the surface layer is made of silicone rubber and the lower layer is made of gelatin.

(Embodiment x6)
The entity model according to the embodiment x6 has a shape equivalent to that of the eyelid in the group X described above. The entity model 10F of the present embodiment has the appearance shape of the eyelids in the face shown in FIG. 6A and has a cross-sectional structure as shown in FIG. FIG. 6A is a schematic diagram showing the overall shape of a face model including an example of the eyelid model of the present embodiment, and FIG. 6B shows the PP cross section in the eyelid portion of FIG. A schematic sectional view is shown. In FIG. 6A and FIG. 6B, the surface layer 1F covers the entire surface of the lower layer 2F, but may cover a part of the surface of the lower layer 2F depending on the desired surgical site. In the present embodiment, the surface layer 1F corresponds to the skin of the eyelid (including the epidermis and dermis), and the lower layer 2F corresponds to the subcutaneous tissue of the eyelid (including the muscle layer, the scalp and fat).

  In the present embodiment, the elastic modulus of the lower layer 2F is in the range of 10 to 80% with respect to the elastic modulus of the surface layer 1F from the viewpoint of further approximation of the feel between the real model and the actual human eyelid. It is preferably 10 to 70%, more preferably 30 to 60%. The ratio between the elastic modulus of the lower layer and the elastic modulus of the surface layer is preferably 1: 1.5 to 1:10, more preferably 1: 1.5 to 1:10, and further preferably 1: 2 to 2. 1: 5.

In this embodiment, the elastic modulus of the lower layer and the surface layer is usually within the following range:
Lower layer: 1.0 × 10 ^{3 to} 2.0 × 10 ⁵ Pa, preferably 5.0 × 10 ^{3 to} 1.5 × 10 ⁵ Pa, more preferably 5.0 × 10 ^{4 to} 1.2 × 10 ⁵ Pa Pa;
Surface layer: 0.5 × 10 ^{5 to} 0.5 × 10 ⁶ Pa, preferably 1.0 × 10 ^{5 to} 5.0 × 10 ⁵ Pa, more preferably 1.0 × 10 ^{5 to} 3.0 × 10 ⁵ Pa.

The absolute value of the difference between the elastic modulus of the elastic material constituting the lower layer and the elastic material constituting the surface layer is a more approximate approximation of the feel between the eyelid model of this embodiment and the actual human eyelid. terms, is preferably ^{1.0 × 10 4 ~5.0 × 10 5} Pa, more preferably ^{1.0 × 10 4 ~3.0 × 10 5} Pa, 5.0 × 10 4 More preferably, it is -2.0 * 10 < ⁵ > Pa.

In this embodiment, the loss tangent of the lower layer and the surface layer is usually in the following range:
Lower layer: 0.1-0.5, preferably 0.1-0.4, more preferably 0.15-0.3;
Surface layer: 0.1-0.5, preferably 0.1-0.4, more preferably 0.15-0.3.

In this embodiment, the thickness of the surface layer 1F is usually in the following range:
The thickness of the surface layer 1F _t 1F: 0.3~2mm.
The thickness of the lower layer 2F is not particularly limited as long as the total thickness _TF is approximately the same as the actual thickness of a human eyelid.

  In the eyelid model of this embodiment, the surface layer and the lower layer may each be composed of the elastic material described above, but preferably the surface layer is composed of urethane rubber or silicone rubber, and the lower layer is composed of gelatin or silicone rubber. . More preferably, the surface layer is made of urethane rubber or), and the lower layer is made of silicone rubber.

(Embodiment x7)
The entity model according to the embodiment x7 has a shape equivalent to the brain (cerebrum) in the group X described above. In the present embodiment, the entity model having the shape of the brain has a coronal section as shown in FIG. FIG. 7 shows a schematic coronal sectional view of the entity model 10G. In FIG. 7, the surface layer 1G covers the entire surface of the lower layer 2G, but may cover a part of the surface of the lower layer 2G depending on the desired surgical site. In this embodiment, the surface layer 1G corresponds to the cerebral cortex and the lower layer 2G corresponds to the medulla.

  In the present embodiment, the elastic modulus of the lower layer 2G is in the range of 10 to 80% with respect to the elastic modulus of the surface layer 1G from the viewpoint of further approximation of the touch between the real model and the actual human cerebrum. It is preferably 10 to 70%, more preferably 30 to 60%. The ratio between the elastic modulus of the lower layer and the elastic modulus of the surface layer is preferably 1: 1.5 to 1:10, more preferably 1: 1.5 to 1:10, and more preferably 1: 2 to 2. 1:10.

In this embodiment, the elastic modulus of the lower layer and the surface layer is usually within the following range:
Lower layer: 1.0 × 10 ^{3 to} 2.0 × 10 ⁵ Pa, preferably 5.0 × 10 ^{3 to} 1.5 × 10 ⁵ Pa, more preferably 5.0 × 10 ^{4 to} 1.2 × 10 ⁵ Pa Pa;
Surface layer: 0.5 × 10 ^{5 to} 0.5 × 10 ⁶ Pa, preferably 1.0 × 10 ^{5 to} 5.0 × 10 ⁵ Pa, more preferably 1.0 × 10 ^{5 to} 3.0 × 10 ⁵ Pa.

The absolute value of the difference between the elastic modulus of the elastic material constituting the lower layer and the elastic material constituting the surface layer is a more approximate approximation of the feel between the brain model of this embodiment and the actual human brain. terms, is preferably ^{1.0 × 10 4 ~5.0 × 10 5} Pa, more preferably ^{1.0 × 10 4 ~3.0 × 10 5} Pa, 5.0 × 10 4 More preferably, it is -2.0 * 10 < ⁵ > Pa.

In this embodiment, the loss tangent of the lower layer and the surface layer is usually in the following range:
Lower layer: 0.1-0.5, preferably 0.1-0.4, more preferably 0.15-0.3;
Surface layer: 0.1-0.5, preferably 0.1-0.4, more preferably 0.15-0.3.

In this embodiment, the thickness of the surface layer 1G is usually in the following range:
The thickness t 1G of the surface layer 1G: _{1 to} 15 mm.
The thickness (dimension) of the lower layer 2G is not particularly limited as long as the overall dimension _TG of the cerebrum is comparable to that of the actual human cerebrum.

  In the cerebral model of this embodiment, the surface layer and the lower layer may each be made of the elastic material described above, but preferably the surface layer is made of silicone rubber and the lower layer is made of gelatin or silicone rubber. More preferably, the surface layer is made of silicone rubber and the lower layer is made of gelatin.

<Embodiment Y>
In this embodiment Y, the elastic modulus of the lower layer is higher than the elastic modulus of the surface layer.
For example, when the substantial model has a shape equivalent to the auricle, the elastic modulus of the lower layer is higher than that of the surface layer. In this case, the elastic modulus of the lower layer and the surface layer may be adjusted so that the feel of the real model of this embodiment and the feel of the actual human body part are closely approximated. It is usually in the range of 100.1 to 500%, preferably 101 to 500%, more preferably 110 to 300, and still more preferably 120 to 200% with respect to the elastic modulus of the layer. The ratio between the elastic modulus of the lower layer and the elastic modulus of the surface layer is preferably 1.2: 1 to 6: 1, more preferably 1.3: 1 to 5: 1, and still more preferably 1.4: It is 1-4: 1, More preferably, it is 1.4: 1-3: 1.

In this embodiment Y, the elastic moduli of the lower layer and the surface layer are usually in the following ranges:
^{Lower: 5.0 × 10 4 ~1.0 × 10} 7 Pa, preferably ^{5.0 × 10 4 ~1.0 × 10 6} Pa, more preferably 1.0 × ¹⁰ 5 ~1.0 × ^{10 6} Pa;
Surface layer: 1.0 × 10 ^{4 to} 1.0 × 10 ⁶ Pa, preferably 5.0 × 10 ^{4 to} 7.0 × 10 ⁵ Pa, more preferably 1.2 × 10 ^{5 to} 4.0 × 10 ⁵ Pa.

The absolute value of the difference between the elastic modulus of the elastic material composing the lower layer and the elastic material composing the surface layer is a more approximate approximation of the feel between the lip model of this embodiment and the actual human lip. From the viewpoint, it is preferably 1.0 × 10 ^{4 to} 1.0 × 10 ⁶ Pa, more preferably 1.0 × 10 ^{5 to} 1.0 × 10 ⁶ Pa, and 1.0 × 10 ⁵ Pa. More preferably, it is -5.0 * 10 < ⁵ > Pa.

In this embodiment, the loss tangent of the lower layer and the surface layer is usually in the following range:
Lower layer: 0.1-0.5, preferably 0.1-0.4, more preferably 0.15-0.3;
Surface layer: 0.1-0.5, preferably 0.1-0.4, more preferably 0.15-0.3.

  In the present embodiment Y, the elastic material constituting the surface layer and the lower layer may be independently selected from the above-described range. In this embodiment Y, the elastic material constituting the surface layer is silicone rubber or polyurethane rubber from the viewpoint of further approximating the feeling between the real model of the present invention and the actual human body part, and the lower layer is constituted. The elastic material to be used is preferably silicone rubber or polyurethane rubber.

  In the embodiment Y, the contents of the curing agent and / or solvent in the surface layer and the lower layer may be appropriately set and selected so that the surface layer and the lower layer have the above-described elastic modulus relationship.

  The embodiment y1 will be specifically described as the embodiment Y.

(Embodiment y1)
The entity model according to the embodiment y1 has a shape equivalent to the auricle. In this embodiment, the entity model 10H having the shape of the auricle has the entire shape of the auricle as shown in FIG. 8A, and has a cross-sectional structure as shown in FIG. 8B. FIG. 8A is a schematic view showing the overall shape of the entity model 10H, and FIG. 8B is a schematic cross-sectional view of the PP cross section of FIG. 8A viewed in the direction of the arrow. In FIG. 8B, the surface layer 1H covers the entire surface of the lower layer 2H, but may cover a part of the surface of the lower layer 2H according to a desired surgical site. In this embodiment, the surface layer 1H corresponds to the skin of the auricle (including the epidermis and dermis), and the lower layer 2H corresponds to the cartilage of the auricle.

  In the present embodiment y1, the ratio of the elastic modulus of the lower layer 2H to the elastic modulus of the surface layer 1H and the lower layer elastic modulus and the surface layer from the viewpoint of further approximating the feeling between the real model and the actual human pinna The ratio to the elastic modulus is the same as that in the above embodiment Y.

  In the present embodiment y1, the elastic modulus of the lower layer and the surface layer, the absolute value of the difference between the elastic modulus of the elastic material constituting the lower layer and the elastic modulus of the elastic material constituting the surface layer, and the loss tangent of the lower layer and the surface layer Is usually the same as in embodiment Y described above.

In this embodiment, the thicknesses of the lower layer 2H and the surface layer 1H are usually within the following ranges, respectively:
Lower layer 2H thickness t _2H : 1 to 3 mm;
The thickness of the surface layer 1H _t 1H: 0.3~5mm.

  As described above, the case where the substantial model is a two-layer model including only the surface layer and the lower layer has been described. However, the present invention does not prevent further including layers other than the surface layer and the lower layer, and a multilayer having a three-layer structure or more. You may have a structure.

  Although the case where both the surface layer and the lower layer constituting the entity model are single layers has been described, in the present invention, the surface layer and the lower layer may be each independently a single layer, or a plurality of layers. There may be.

  Although the case where the entity model has a shape equivalent to a human body part has been described, it may have a shape equivalent to a body part of an animal other than a human.

<Embodiment Z>
This embodiment Z is an embodiment in which the actual model of the embodiments X and Y described above further includes a deep layer disposed on the side opposite to the lower surface layer side. That is, this embodiment Z is the same as embodiments X and Y except that the substantial model further includes a deep layer disposed on the side opposite to the surface layer side of the lower layer. Thereby, the touch of the real model of the present invention is more similar to the touch of the actual human body part.

  In this embodiment Z, the elastic material constituting the lower layer is the above-described elastic material other than the silicone gel, and the substance model further includes a later-described deep layer disposed on the side opposite to the surface layer side of the lower layer. Preferred is the same as in embodiment X, in particular embodiment x1.

  This embodiment Z includes the following embodiment z1.

(Embodiment z1)
This embodiment z1 is the above except that the thickness of the lower layer is in the same range as the thickness of the surface layer, and that the substantial model further includes a deep layer described later disposed on the side opposite to the surface layer side of the lower layer. The same as in the embodiment x1.

  Specifically, the entity model according to the embodiment z1 has a shape equivalent to a breast. In the present embodiment, the entity model 10A 'having a breast shape has a cross-sectional structure as shown in FIG. That is, the entity model 10A 'includes a surface layer 1A' and a lower layer 2A ', and further includes a deep layer 6A' disposed on the side opposite to the surface layer side of the lower layer 2A '. In this embodiment, the surface layer 1A 'corresponds to the epidermis of the breast, the lower layer 2A' corresponds to the dermis, and the deep layer 6A 'corresponds to the subcutaneous tissue of the breast (including mammary tissue and fat).

  The surface layer 1A ′ is the same as the surface layer 1A in the embodiment x1, and may be selected from the surface layer 1A.

  The lower layer 2A ′ is a lower layer in the embodiment x1 except that the thickness of the lower layer is in the same range as the thickness of the surface layer and that the elastic material constituting the lower layer is the above-described elastic material other than the silicone gel. Same as 2A.

  The deep layer 6A 'is a liquid and is made of a substance in a liquid state at 25 ° C. The substance constituting the deep layer 6A 'may be any liquid as long as it is in a liquid state at 25 ° C and does not dissolve the lower layer, and may be water, physiological saline, silicone oil, or the like. The preferred depth is water or saline.

  Specifically, in this embodiment z1, the ratio of the elastic modulus of the lower layer to the elastic modulus of the surface layer, the ratio of the elastic modulus of the lower layer and the elastic modulus of the surface layer, the elastic modulus of the lower layer and the surface layer, and the elastic material constituting the lower layer Unless otherwise specified, the absolute value of the difference between the elastic modulus of the elastic layer and the elastic modulus of the elastic material constituting the surface layer, and the loss tangent of the lower layer and the surface layer (hereinafter simply referred to as “elastic property value”) This is the same as the elastic characteristic value of x1.

  In this embodiment z1, it is preferable that the elastic characteristic value is particularly the same as the elastic characteristic value of the non-droop type breast model in the above-described embodiment x1. At this time, the breast model of the embodiment z1 is particularly useful as a middle-aged model. The middle-aged type means an intermediate type in which the degree to which the breast hangs according to gravity is generally positioned between the non-pendant type breast model (young type) and the pendant type breast model (aged type).

  In the real model of this embodiment, the volume ratio of the total volume of the surface layer 1A ′ and the lower layer 2A ′ to the volume of the deep layer 6A ′ is usually 0.1: 99.9 to 50:50, particularly 1:99. ~ 50: 50, and from the viewpoint of a further approximation of the feel between the real model and the actual human breast, it is preferably 1: 99-30: 70, more preferably 1: 99-20: 80 Yes, more preferably 1:99 to 10:90.

In this embodiment, the thicknesses of the lower layer 2A ′, the surface layer 1A ′, and the deep layer 6A ′ are usually within the following ranges, respectively:
Lower layer 2A ′ thickness t _{2A ′} : 0.3 to 10 mm, preferably 0.3 to 5 mm, more preferably 0.3 to 2 mm, still more preferably 0.5 to 1 mm;
'Thickness _{t 1A'} of the surface layer 1A: 0.3 to 10 mm, preferably 0.3 to 5 mm, more preferably 0.3 to 2 mm, more preferably 0.5 to 1 mm:
'Thickness _{t 6A of'} deep 6A: 10~150mm.
In the present specification, a numerical range for thickness means that the thickness may vary within the numerical range.

  In the breast model of this embodiment, the surface layer and the lower layer may each be made of the elastic material described above, but preferably the surface layer is made of silicone rubber or urethane rubber, and the lower layer is made of silicone rubber or urethane rubber. The More preferably, the surface layer is made of urethane rubber and the lower layer is made of silicone rubber.

  The breast model of the present embodiment can perform an operation simulation assuming that a lesion (for example, a tumor) is present in the surface layer, the lower layer, or a region between them, or drains water with a syringe and performs an actual operation. Before, it is possible to perform a surgery simulation to know the degree of deformation after surgery and the shape of the sag after surgery.

[Use entity model]
The substantial model of the present invention is useful as a teaching material for doctor training by mass-producing a specific shape having the same shape.

Specifically, since the actual model of the present invention has a feeling that is close to that of an actual human body part, the feel when incising with a scalpel, the feel when suturing the incision, and the actual human body It is close to the part.
In addition, since the actual model of the present invention closely approximates the actual human body part, the drooping shape at the time of surgery and the appropriate removal volume when removing the lesion by surgery are also included in the removed part. The appropriate filling volume when filling materials such as silicone or autologous tissue also closely approximates the actual human body part.
Furthermore, by performing a simulated operation using the three-dimensional entity model of the present invention, the degree of deformation after the operation can be known.

  For this reason, the substantial model of the present invention can sufficiently contribute to the improvement of the doctor's surgical skill, the creation of a surgical plan that fits well with the actual surgery, and the easy-to-understand explanation of the surgery to the patient. Can do.

  The actual model of the present invention can be easily provided with the shape of a congenital or acquired lesion site (for example, cleft lip site) that is different for each patient by custom-made, so that the details can be adapted to individual patients. Can create a surgical plan. For example, a lip model having a cleft lip portion may be a mold in which a shape corresponding to the cleft lip portion is provided on the molding surface when forming the lower layer in the casting-lamination method described later.

The substantial model of the present invention can also perform a surgical simulation that is more similar to an actual operation by being given a tumor in advance.
Specific examples of the entity model having a tumor of the present invention are shown in embodiments p1 to p3.

(Embodiment p1)
The entity model according to the embodiment p1 has the entire shape of the face. In this embodiment, the body model 10I having a facial shape has an overall shape as shown in FIG. 10, and a skin tumor 5I is given to the cheek portion thereof. In FIG. 10, the skin tumor 5I is applied to the cheek part, but may be applied to other specific parts such as the forehead part and the chin part.

  The entity model 10I is an entity model (skin structure model) 10D according to the embodiment x4 except that the face shape is given to the surface layer 1D side and the skin tumor 5I is given to the cheek portion thereof. It is the same. The entity model 10I, particularly the cheek portion, has the same cross-sectional structure as the skin structure model according to the embodiment x4 except that the face shape is given to the surface layer 1D side.

  The method for applying skin tumor 5I is not particularly limited. For example, it can be applied by drawing with oil-based ink or the like on the surface of entity model 10I.

  By performing an operation simulation for excising the tumor 5I using the entity model 10I, it is possible to contribute to improvement of the design ability of a doctor such as flap arthroplasty.

(Embodiment p2)
The entity model according to embodiment p2 has a breast shape. In the present embodiment, the entity model 10J having a breast shape has a cross-sectional shape as shown in FIG. 11, and a tumor 5J is provided therein. In FIG. 11, the tumor 5J is disposed at a depth d of 20 mm from the surface of the surface layer 1A. However, the tumor 5J may be measured and defined from the patient image.

  The entity model 10J is the same as the entity model (breast model) 10A according to the embodiment x1 except that the tumor 5J is provided inside the lower layer 2A.

  The tumor 5J is made of an organic elastic material having a higher elastic modulus than that of the lower layer 2A, and is usually made of an organic elastic material having the same elastic modulus as the surface layer 1A in the embodiment X.

  Specific examples of the organic elastic material constituting the tumor 5J include the same organic elastic materials (particularly polymers) exemplified as the organic elastic material constituting the surface layer. The preferable tumor 5J from the viewpoint of approximating the feel with the actual tumor part is composed of the same type of organic elastic material as the organic elastic material constituting the surface layer 1A, and the more preferable tumor 5J is silicone rubber from the same viewpoint. Or composed of gelatin. For example, when the surface layer 1A is made of silicone rubber, the tumor 5J is also preferably made of silicone rubber. For example, when the lower layer 2A is made of gelatin, the tumor 5J is preferably made of silicone rubber or gelatin, particularly gelatin.

As the silicone rubber constituting the tumor 5J, the same commercially available products exemplified as the commercially available silicone rubber constituting the surface layer can be used.
As the gelatin constituting the tumor 5J, a commercially available product similar to the gelatin constituting the surface layer can be used.

  The tumor 5J may also contain additives such as a curing agent, a coloring agent, and a solvent in addition to the elastic material, similarly to the surface layer. Specifically, when the tumor 5J is composed of a polymer other than gelatin among the above polymers, the tumor 5J usually contains a polymer other than the gelatin and a hardening agent, and may further contain a colorant. When the tumor 5J is composed of gelatin, the tumor 5J usually contains the gelatin and a solvent, and may further contain a colorant.

  The types of the curing agent and the solvent contained in the tumor 5J may be selected from the same range as the types of the curing agent and the solvent contained in the surface layer, respectively.

  When the tumor 5J is composed of a polymer other than gelatin, the content of the hardener in the tumor 5J may be usually in the same range as the content range of the hardener in the surface layer in the embodiment X. When the tumor 5J is composed of gelatin, the solvent content of the tumor 5J may be usually in the same range as the solvent content range of the surface layer in the embodiment X.

  The type and content of the colorant contained in the tumor 5J may be selected from the same range as the type and content of the colorant contained in the surface layer, respectively.

By performing an operation simulation for excising the tumor 5J using the entity model 10I, for example, the following matters can be known in advance before the actual operation:
(I) a suitable removal volume when removing the lesion;
(Ii) an appropriate filling volume when filling the removed site with a material such as silicone or autologous tissue;
(Iii) degree of deformation after surgery; and (iv) drooping shape after surgery.

(Embodiment p3)
The entity model according to embodiment p3 has a skin structure shape. In this embodiment, the body model 10K having a skin structure shape has a cross-sectional shape as shown in FIG. 12, and a skin tumor 5K protruding from both the upper surface and the lower surface of a part of the surface layer is applied. . In FIG. 12, the tumor 5K has a substantially circular shape also in the surface direction of the surface layer 1D, and has a diameter of, for example, 20 mm. However, the diameter may be adjusted according to the value measured from the patient image. Alternatively, the difficulty of the simulated operation may be adjusted by controlling the diameter.

  The entity model 10K is the same as the entity model (skin structure model) 10D according to the embodiment x4 except that a tumor 5K is applied to a part of the surface layer 1D.

  The tumor 5K is composed of an organic elastic material having an elastic modulus higher than that of the lower layer 2D, and usually has the same composition as the surface layer 1D in the embodiment X.

  By performing an operation simulation for excising the tumor 5K using the entity model 10K, for example, items (i) to (iii) in the embodiment p2 can be known in advance before the actual operation.

[Production method of entity model]
The entity model of the present invention can be manufactured by a method including the following steps:
A step of curing a surface layer-forming resin composition containing a curable material to form a surface layer; and a step of curing a lower layer forming resin composition containing a curable material to form a lower layer.

  The execution order of the surface layer forming step and the lower layer forming step may be appropriately determined according to the structure of the entity model and the method of forming each layer. For example, after the surface layer forming step is performed, the lower layer forming step may be performed, or after the lower layer forming step is performed, the surface layer forming step may be performed.

  In the surface layer forming step and the lower layer forming step, a casting method, a laminating method, an injection method, a composite method thereof, and the like can be employed independently.

(Casting-Casting method)
For example, when manufacturing the breast model shown in FIGS. 1A and 1B, the surface layer and the lower layer can be formed by the casting-casting method shown in FIG.

Casting-casting process includes the following steps.
A step of curing a resin composition for forming a surface layer containing a curable material by a casting method to form a surface layer; and a resin composition for forming a lower layer containing a curable material by a casting method to cure a lower layer Forming.
By adjusting the curing conditions of the surface layer and the lower layer, the elastic modulus of the surface layer and the lower layer can be controlled.

  Specifically, first, as shown in FIG. 13 (A), the surface layer forming resin composition is poured into the lower mold 100 having a desired shape on the molding surface 101, and then desired on the molding surface 111. The upper mold 110 provided with the shape is moved downward and cured to form the surface layer 1A.

  The resin composition for forming a surface layer includes a curable material, and may include various additives such as the above-described curing agent, colorant, and solvent, if desired. The curable material is an elastic material (particularly an organic elastic material) or a material that can form the elastic material. For example, when the curable material is a polymer other than gelatin and silicone gel, the resin composition for forming a surface layer includes the polymer and a curing agent, and optionally includes a colorant. For example, when the curable material is gelatin, the resin composition for forming a surface layer contains the gelatin and a solvent, and optionally contains a colorant.

  Next, as shown in FIG. 13B, the upper mold 110 is moved upward and retracted.

  Thereafter, as shown in FIG. 13C, after pouring the lower layer forming resin composition onto the surface layer 1 </ b> A in the lower mold 100, the upper mold 120 provided with a desired shape on the molding surface 121 is formed. It is moved downward and cured to form the lower layer 2A.

  The resin composition for lower layer formation contains a curable material, and may contain various additives, such as the above-mentioned hardening | curing agent, a coloring agent, and a solvent, as needed. The curable material is an elastic material (particularly an organic elastic material) or a material that can form the elastic material. For example, when the curable material is a polymer other than gelatin and silicone gel, the resin composition for forming a lower layer includes the polymer and a curing agent, and optionally includes a colorant. For example, when the curable material is and / or a silicone gel, the resin composition for forming a lower layer contains the gelatin and a solvent, and optionally contains a colorant.

  Curing for forming the surface layer and the lower layer may be performed independently by heating, or by light irradiation, depending on the type of the curable material, or may be cooled (kept at room temperature). Or by a combination of these methods. For example, when the curable material is a polymer other than gelatin, a resin composition at room temperature (25 ° C.) containing the polymer and a curing agent is poured, and then heated, irradiated with light, and / or kept at room temperature. To cure. For example, when the curable material is gelatin, a resin composition containing 45 to 70 ° C. containing the gelatin and a solvent is poured, and then cooled to room temperature (25 ° C.) or lower, for example 5 to 8 ° C. To cure.

  At the time of curing for forming the surface layer and the lower layer, it is preferable to control the elastic modulus of the surface layer and the lower layer by adjusting the curing conditions. Curing conditions are from the group consisting of the mixing ratio of the curing agent or solvent in the surface layer forming resin composition and the lower layer forming resin composition, and the heating temperature, heating time and light irradiation amount for curing the surface layer and the lower layer. One or more conditions to be selected. From the viewpoint of preventing the change in elastic modulus over time after the completion of the real model, the elasticity of the surface layer and the lower layer can be adjusted by adjusting the blending ratio of the curing agent or solvent as long as heating and / or light irradiation is sufficiently performed. It is preferable to control the rate.

  As shown in FIG. 1B, when the breast model has a curved support 3A and a mold 5A, the curved support 3A and the mold 5A are manufactured in advance, and the curved support is placed in the mold 5A. After accommodating and fixing 3A, the breast model manufactured by the above method may be accommodated.

  By such casting-casting method, the skin structure model shown in FIG. 4, the face model having the skin tumor shown in FIG. 10, the breast model having the tumor shown in FIG. 11, and the skin having the skin tumor shown in FIG. Structure models can also be manufactured.

In particular, the breast model having a tumor shown in FIG. 11 may be formed by inserting the previously manufactured tumor 5J after forming the lower layer 2A. The lower layer 2A has an elastic modulus and a softness that can insert the tumor 5J.
For example, the skin structure model having a skin tumor shown in FIG. 12 may use a mold having a desired shape on the molding surface when forming the surface layer 1D.

(Cast-lamination method)
Further, for example, when the liver model shown in FIG. 2 is manufactured, after forming the lower layer 2B by a casting method, the surface layer 1B can be formed by a lamination method.

The casting-lamination method includes the following steps.
A step of curing a resin composition for forming a lower layer containing a curable material by a casting method to form a lower layer; and a resin composition for forming a surface layer containing a curable material on the surface of the lower layer by a lamination method. Forming the surface layer.
By adjusting the curing conditions of the surface layer and the lower layer, the elastic modulus of the surface layer and the lower layer can be controlled.

Specifically, first, after pouring the lower layer forming resin composition into the lower mold having a desired shape on the molding surface, the upper mold having the desired shape on the molding surface is moved downward and cured. To form the lower layer 2B. The method of forming the lower layer by the casting method is the same as the method of forming the surface layer by the casting-casting method described above, except for the following matters:
-The shape of the lower layer is different; and-Only the lower layer is formed.

  The lower layer forming resin composition is the same as in the lower layer forming method by the casting-casting method described above.

  Subsequently, the resin composition for surface layer formation is apply | coated to the surface of the lower layer 2B, and it hardens | cures. The application is preferably performed once or a plurality of times so as to achieve a desired thickness.

  The resin composition for forming the surface layer is the same as that in the method for forming the surface layer by the casting-casting method described above.

  Curing for forming the surface layer and the lower layer is the same as in the method for forming the surface layer and the lower layer by the casting-casting method described above.

  By such a casting-lamination method, the breast model shown in FIGS. 1A and 1C, the lip model shown in FIG. 3, the outer nose model shown in FIG. 5, the eyelid model shown in FIG. 6, and the model shown in FIG. A brain model, an auricle model shown in FIG. 8, can also be manufactured. When the breast model shown in FIGS. 1A and 1C is manufactured by the casting-lamination method, the lid 60 described later shown in FIG. 3C is not necessary. )

(Lamination-injection method) (two-layer model)
Further, for example, in manufacturing the breast model shown in FIGS. 1A and 1C, in which the lower layer is a silicone gel, the surface layer 1A is formed by the laminating method, and then the lower layer 2A is formed by the injection method. Can be formed.

The stack-injection method (two-layer model) includes the following steps.
A step of curing a resin composition for forming a surface layer containing a curable material on the surface of a salt mold by a lamination method, removing the salt mold to form a hollow surface layer; and a hollow surface layer by an injection method A step of injecting a material (silicone gel) constituting the lower layer into the lower layer to form the lower layer.
The elastic modulus of the surface layer can be controlled by adjusting the curing condition of the surface layer.

  Specifically, first, as shown in FIG. 14, the surface layer forming resin composition is applied to the salt mold 200 having the molded part 210 and the handle part 220 each having a desired shape on the molding surface, dry. Curing may be performed with drying. Application is performed on the surface of the salt mold 200 (that is, the molding part 210) other than the handle 220. The application is preferably performed once or a plurality of times so as to achieve a desired thickness. As a result, a surface layer molded body is formed on the surface of the molding part 210 of the salt mold 200. In the salt mold 200, the molding part 210 and the handle part 220 are all made of salt (NaCl). The resin composition for forming the surface layer is the same as that in the method for forming the surface layer by the casting-casting method described above.

  Thereafter, the salt mold 200 is destroyed, and the debris is removed from the hole in the handle portion on the back surface of the molded body to obtain a hollow surface layer molded body. Silicone gel is injected from the hole of the hollow surface layer molding. Thereafter, the molded body may be cured. After the injection, the lid 60 is attached to the hole and closed, and the breast model shown in FIG. 1C is obtained. The lid 60 may be a sheet-like or film-like polymer having good adhesion to the surface layer 1A. Such a polymer is not particularly limited as long as it can close the hole, and for example, the same type of polymer as the material constituting the surface layer is preferably used. Examples of the polymer include polyurethane and polyester. The lid 60 may be attached with an adhesive.

  Curing for forming the surface layer is the same as in the method for forming the surface layer by the casting-casting method described above.

(Lamination-injection method) (Three-layer model)
Further, for example, in manufacturing the breast model shown in FIG. 9, the lower layer 2A ′ and the surface layer 1A ′ can be formed by the laminating method, and then the deep layer 6A ′ can be formed by the implantation method.

The stack-injection method (three-layer model) includes the following steps.
A step of forming a lower layer by curing a lower layer forming resin composition containing a curable material on a salt-type surface by a lamination method;
A step of curing a resin composition for forming a surface layer containing a curable material on the surface of a lower layer by a lamination method to form a surface layer, removing a salt form to obtain a hollow laminate; and an injection method, A step of injecting a liquid material constituting the above-described deep layer into the hollow laminate to form the deep layer.
By adjusting the curing conditions of the surface layer and the lower layer, the elastic modulus of the surface layer and the lower layer can be controlled.

  Specifically, as shown in FIG. 14, first, a lower layer forming resin composition is applied to a salt mold 200 having a molding part 210 and a handle part 220 each having a desired shape on the molding surface, and then dried. Let Curing may be performed with drying. Application is performed on the surface of the salt mold 200 (that is, the molding part 210) other than the handle 220. The application is preferably performed once or a plurality of times so as to achieve a desired thickness. In the salt mold 200, the molding part 210 and the handle part 220 are all made of salt (NaCl). The lower layer forming resin composition is the same as in the lower layer forming method by the casting-casting method described above.

  Subsequently, the resin composition for surface layer formation is apply | coated to the surface of a lower layer, and it is made to dry. Curing may be performed with drying. The application is preferably performed once or a plurality of times so as to achieve a desired thickness. As a result, a laminated molded body of the lower layer and the surface layer is formed on the surface of the molding part 210 of the salt mold 200. The resin composition for forming the surface layer is the same as that in the method for forming the surface layer by the casting-casting method described above.

  Thereafter, the salt mold 200 is destroyed, and the debris is removed from the hole in the handle portion on the back surface of the molded body to obtain a hollow laminated molded body. A liquid material constituting the deep layer is injected from the hole of the hollow laminated molded body. Thereafter, the molded body may be cured. After the injection, the lid 60 is attached to the hole and closed, and the breast model shown in FIG. 9 is obtained. The lid 60 may be the same as the lid in the two-layer model stack-injection method.

  Curing for forming the surface layer and the lower layer is the same as in the method for forming the surface layer and the lower layer by the casting-casting method described above.

(Example A1: Production of breast model)
The breast model shown in FIGS. 1A and 1B was manufactured by the casting-casting method shown in FIG.
Specifically, as shown in FIG. 13A, first, after pouring the surface layer forming resin composition into the lower mold 100 having a predetermined shape on the molding surface 101, the molding surface 111 has a predetermined shape. The upper mold | type 110 provided with was moved downward, hardening was performed, and the surface layer 1A was formed (casting method).

The resin composition for forming the surface layer was obtained by mixing silicone rubber (KE-1308; manufactured by Shin-Etsu Chemical Co., Ltd.) and a curing agent (CAT-1300L-4; manufactured by Shin-Etsu Chemical Co., Ltd.). . Table 1 shows the ratio between the silicone rubber and the curing agent. Curing for the formation of the surface layer 1A was carried out by heating in an oven at 100 ° C. for 1 hour after standing for 24 hours. The thickness t _1A of the surface layer 1A was 1 mm.

Next, as shown in FIG. 13B, the upper mold 110 was moved upward and retracted.
Thereafter, as shown in FIG. 13C, after pouring the lower layer forming resin composition onto the surface layer 1A in the lower mold 100, the upper mold 120 having a predetermined shape on the molding surface 121 is formed. It was moved downward and cured to form the lower layer 2A (casting method). The thickness t _{2A of the} lower layer 2A was 50 mm.

  The resin composition for lower layer formation was obtained by mixing silicone rubber (KE-1308; manufactured by Shin-Etsu Chemical Co., Ltd.) and a curing agent (CAT-1300L-4; manufactured by Shin-Etsu Chemical Co., Ltd.). Table 1 shows the ratio between the silicone rubber and the curing agent. Curing for the formation of the lower layer was performed by heating in an oven at 100 ° C. for 1 hour after standing for 24 hours.

  The volume ratio of the surface layer to the lower layer was 2:98.

  The obtained breast model precursor composed of the surface layer 1A and the lower layer 2A is housed in a mold 5A in which the curved support 3A is housed and fixed, and the breast model shown in FIGS. 1 (A) and (B). Got. Both the curved support 3A and the mold 5A were made of plastic.

  The feel when pressed from the surface of the surface layer 1A toward the lower layer 2A closely approximated the feel when pressed from the surface of the actual human breast toward the inside.

  The elastic modulus of the lower layer 2A, the elastic modulus and loss tangent of the surface layer 1A were measured by the method described later. The values are shown in Table 1, and the elastic characteristic values obtained from these values are shown in Table 2. The elastic modulus of the lower layer 2A is lower than the elastic modulus of the surface layer 1A, and the elastic modulus A when pressing from the surface of the surface layer 1A toward the lower layer 2A is pressed from the surface of the actual human breast toward the inside. Of the elastic modulus B of -10 to + 10%.

  The content of the curing agent in the surface layer 1A and the lower layer 2A is such that the content of the curing agent in the lower layer 2A with respect to the silicone rubber is less than the content of the curing agent in the surface layer 1A with respect to the silicone rubber, and from the surface of the surface layer 1A to the lower layer The amount of the touch when it was pressed toward the inside was a quantity that closely approximated the touch when it was pressed from the surface of the actual human breast toward the inside.

(Example A2: Production of tumor-bearing breast model)
A breast model having a tumor shown in FIG. 11 was produced by a casting-casting method shown in FIG.
Specifically, first, a surface layer 1A made of silicone rubber was formed by the same method as in Example A1.

Next, as shown in FIG. 13B, the upper mold 110 was moved upward and retracted.
Thereafter, as shown in FIG. 13C, after pouring the lower layer forming resin composition onto the surface layer 1A in the lower mold 100, the upper mold 120 having a predetermined shape on the molding surface 121 is formed. It was moved downward and cured to form the lower layer 2A (casting method). The thickness t _{2A of the} lower layer 2A was 50 mm.

  The resin composition for lower layer formation was obtained by mixing gelatin (commercial edible product) with water and dissolving by heating to 55 ° C. Curing for the formation of the lower layer was performed by leaving it sufficiently at room temperature of 25 ° C.

  The volume ratio of the surface layer to the lower layer was 2:98.

  Thereafter, a previously produced tumor 5J was inserted into a predetermined position of the lower layer 2A. Tumor 5J has a spherical shape with a diameter of 30 mm, the curing agent content of the surface layer forming resin composition is increased, and the surface layer forming resin composition contains a colorant, It was manufactured by the same method as the surface layer 1A.

  The obtained breast model precursor composed of the surface layer 1A, the lower layer 2A and the tumor 5J is housed in a mold 5A in which the curved support 3A is housed and fixed, and a breast model having a tumor shown in FIG. Obtained. Both the curved support 3A and the mold 5A were made of plastic.

  The feel when pressed from the surface of the surface layer 1A toward the lower layer 2A closely approximated the feel when pressed from the surface of the actual human breast toward the inside.

  The elastic modulus of the lower layer 2A, the elastic modulus and loss tangent of the surface layer 1A were measured by the method described later. The values are shown in Table 1, and the elastic characteristic values obtained from these values are shown in Table 2. The elastic modulus of the lower layer 2A is lower than the elastic modulus of the surface layer 1A, and the elastic modulus A when pressing from the surface of the surface layer 1A toward the lower layer 2A is pressed from the surface of the actual human breast toward the inside. Of the elastic modulus B of -10 to + 10%.

  The content of the hardener in the surface layer 1A and the content of water in the lower layer 2A are such that the feel when pressed from the surface of the surface layer 1A toward the lower layer is pressed from the surface of the human actual breast toward the inside. It was an amount that closely approximated the feel of.

(Example A3: Production of breast model)
The breast model shown in FIGS. 1 (A) and 1 (C) was manufactured by a stack-injection method (two-layer model).
Specifically, first, as shown in FIG. 14, a resin composition for forming a surface layer is applied to a salt mold 200 having a molding part 210 and a handle part 220 each having a desired shape on the molding surface and cured. The surface layer 1A was obtained (lamination method). The application was performed on the surface of the salt mold 200 other than the handle 220 (that is, the molding part 210) while rotating the salt mold so that the resin composition does not sag and bias in a hot air environment of 40 to 50 ° C. Application was performed multiple times to achieve the desired thickness.

The resin composition for forming the surface layer was obtained by mixing polyurethane (A liquid) and a curing agent (B liquid) of a urethane rubber raw material (Takeflex BRUSH; manufactured by Takebayashi Chemical Industry Co., Ltd.). The ratio of A liquid and B liquid is shown in Table 1. Curing for forming the surface layer 1A was performed by heating in an oven at 100 ° C. for 5 minutes, and then allowed to stand for several hours. The thickness t _1A of the surface layer 1A was 1 mm.

Next, the salt mold 200 was destroyed, and the debris was removed from the hole in the handle portion on the back surface of the molded body. The resin composition for lower layer formation was inject | poured from the hole of the molded object, and lower layer 2A was obtained (injection method). After the injection, a polyurethane sheet was attached to the hole as a lid 60 and closed to obtain a breast model shown in FIG. The thickness t _{2A of the} lower layer 2A was 50 mm.

  As the resin composition for forming the lower layer, silicone gel (Wacker Siligel 612A (manufactured by Asahi Kasei Wacker Silicone Co., Ltd.)) was used.

  The volume ratio of the surface layer to the lower layer was 2:98.

  The elastic modulus of the lower layer 2A, the elastic modulus and loss tangent of the surface layer 1A were measured by the method described later. The values are shown in Table 1, and the elastic characteristic values obtained from these values are shown in Table 2.

(Example A4: Production of breast model)
The breast model shown in FIGS. 1 (A) and 1 (C) was manufactured by a casting-lamination method (two-layer model).
Specifically, first, by using the same method as the casting method for forming the surface layer in Example A1, except that a predetermined resin composition for forming a lower layer and a mold having a predetermined shape were used, Lower layer 2A was formed. The same composition as the resin composition for lower layer formation of Example A1 was used as the resin composition for lower layer formation. Curing for the formation of the lower layer was performed by the same method as the curing for forming the lower layer of Example A1. The thickness t _{2A of the} lower layer 2A was 50 mm.

Subsequently, the resin composition for surface layer formation was apply | coated to the surface of lower layer 2A, it was made to harden | cure, and surface layer 1A was obtained (lamination method). As the resin composition for forming a surface layer, the same composition as the resin composition for forming a surface layer of Example A3 was used. Application and curing were performed in the same manner as application and curing for forming the surface layer in Example A3, respectively. The thickness t _1A of the surface layer 1A was 1 mm.

  The volume ratio of the surface layer to the lower layer was 2:98.

  As the elastic modulus of the lower layer 2A, the elastic modulus and loss tangent of the surface layer 1A were measured by the method described later. The values are shown in Table 1, and the elastic characteristic values obtained from these values are shown in Table 2.

(Examples A5 to A7 and B1)
In each example, a predetermined actual model was manufactured by a casting-stacking method (two-layer model).
In Example A5, a lip model shown in FIGS. 3A and 3B with a cleft lip shape was produced.
In Example A6, the eyelid model shown in FIGS. 6A and 6B was manufactured.
In Example A7, the breast model shown in FIGS. 1A and 1C was manufactured.
In Example B1, the auricle model shown in FIGS. 8A and 8B was manufactured.

  Specifically, first, by using the same method as the casting method for forming the surface layer in Example A1, except that a predetermined resin composition for forming a lower layer and a mold having a predetermined shape were used, A lower layer was formed. As a resin composition for lower layer formation, the composition similar to the resin composition for lower layer formation of Example A1 was used except having changed the ratio of a silicone rubber and a hardening | curing agent as shown in Table 1. Curing for the formation of the lower layer was performed by the same method as the curing for forming the lower layer of Example A1.

  Subsequently, the resin composition for surface layer formation was apply | coated and hardened to the surface of the lower layer, and the surface layer was obtained (lamination method). As the surface layer forming resin composition, the same composition as the surface layer forming resin composition of Example A3 was used except that the ratio of polyurethane and curing agent was changed as shown in Table 1. Application and curing were performed in the same manner as application and curing for forming the surface layer in Example A3, respectively.

Example A5 (FIG. 3B): t _1C 1 mm: TC 12 mm.
Example A6 (FIG. 6B): t _1F 1 mm: TF 5 mm.
Example A7 (FIG. _1C ): t _1A 1 mm: t _2A 50 mm: volume ratio of surface layer to lower layer = 2: 98.
Example B1 (FIG. 8B): t _1H 1 mm: t _2H 2 mm.

  The elastic modulus of the lower layer, the elastic modulus of the surface layer, and the loss tangent were measured by the method described later. These values are shown in Table 1, and the elastic characteristic values obtained from these values are shown in Table 2.

(Example C1: Production of breast model)
The breast model shown in FIG. 9 was manufactured by the lamination-injection method (three-layer model).
Specifically, as shown in FIG. 14, first, a resin composition for forming a lower layer is applied to a salt mold 200 having a molding part 210 and a handle part 220 each having a desired shape on the molding surface and cured. The lower layer 2A ′ was obtained (lamination method). As a resin composition for lower layer formation, the composition similar to the resin composition for lower layer formation of Example A1 was used except having changed the ratio of a silicone rubber and a hardening | curing agent as shown in Table 1. The coating was performed by the same method as the coating for forming the surface layer in Example A3. Curing was performed by the same method as the curing for forming the lower layer of Example A1. 'Thickness _{t 2A'} of the lower layer 2A was 2 mm.

Subsequently, the resin composition for surface layer formation was apply | coated to the surface of lower layer 2A ', it was made to harden | cure, and surface layer 1A' was obtained (lamination method). As the surface forming resin composition, the same composition as the surface layer forming resin composition of Example A3 was used except that the ratio of polyurethane to curing agent was changed as shown in Table 1. The coating was performed by the same method as the coating for forming the surface layer in Example A3. Curing was performed by the same method as the curing for forming the surface layer of Example A3. 'Thickness _{t 1A'} of the surface layer 1A was 1 mm.

Thereafter, the salt mold 200 was destroyed, and the debris was removed from the hole in the handle portion on the back surface of the laminated molded body. Water was injected from the hole of the molded body to obtain a deep layer 6A ′ (injection method). After the injection, a polyurethane sheet was attached to the hole as a lid 60 and closed to obtain a breast model shown in FIG. 'Thickness _{t 6A of'} deep 6A was 50mm.

  The volume ratio of the total volume of the surface layer and lower layer to the volume of the deep layer was 2:98.

  The elastic modulus of the lower layer 2A ', the elastic modulus and loss tangent of the surface layer 1A' were measured by the method described later. These values are shown in Table 1, and the elastic characteristic values obtained from these values are shown in Table 2.

(Comparative Example A1: Production of breast model)
A breast model (one-layer model) was obtained in the same manner as in Example A1, except that the surface layer was formed also in the lower layer region using the resin composition for forming a surface layer.

(Evaluation 1 (feel))
Feeling A when the entity model is pressed by hand from the surface layer toward the lower layer, and Feeling B when the human body part imitated by the entity model is pressed by hand from the surface to the inside Compared.
◎; Feel A was very close to Feel B:
◯; Feel A is similar to Feel B, but not as close as “◎”:
Δ: Feel A is similar to Feel B, but not as close as “◯”:
X: Feel A was not close to Feel B.

(Evaluation 2)
The feel of the actual model manufactured in Examples A1 to A6, B1 and C1 is very close to the feel of the actual human body part that the actual model mimics. Both the feel and the feel when the incision was sutured were very close to the actual human body part.
The feel of the actual model manufactured in Example A7 is sufficiently similar to the feel of the actual human body part imitated by the real model. The feel when doing was also close enough to the actual human body part. However, the feel of the entity model manufactured in Example A7 did not approximate the actual human body part as well as the feel of the entity models manufactured in Examples A1-A6, B1 and C1.

In addition, since the breast models of Examples A1 to A4 and C1 are very close to the actual human breast, the drooping shape at the time of surgery and the appropriate removal volume when removing the lesion by surgery are also provided. The appropriate filling volume when filling the removed site with a material such as silicone or autologous tissue also closely approximated the actual human breast.
Since the breast model of Example A7 is sufficiently close to the actual human breast, the drooping shape at the time of surgery and the appropriate removal volume when removing the lesion by surgery are also present at the removed site. The appropriate filling volume when filling materials such as silicone or autologous tissue also closely approximated the actual human breast. However, in the breast model of Example A7, as well as the breast model of Examples A1 to A4 and C1, the drooping shape at the time of surgery and the appropriate removal volume when removing the lesion by surgery are removed. The proper filling volume when filling materials such as silicone or autologous tissue also did not approximate the actual human breast.

Furthermore, the degree of deformation after the operation could be well known by performing a simulated operation using the actual models of Examples A1 to A7, B1 and C1.
For this reason, the actual models of Examples A1 to A7, B1 and C1 were able to sufficiently contribute to the improvement of the doctor's surgical skill. In addition, the actual models of Examples A1 to A7, B1, and C1 were able to sufficiently contribute to the creation of a surgical plan that fits well with actual surgery.

(Measurement method of complex modulus and loss tangent)
The resin composition for forming a surface layer or the resin composition for forming a lower layer having a predetermined composition in each example or comparative example was cured under the conditions used in each example or comparative example to obtain a sheet-like cured body. A cylindrical specimen having a predetermined size was obtained from the cured body. Using the obtained test piece, the complex elastic modulus and loss tangent were measured by the method and conditions based on JIS K6394: 2007 “Vulcanized rubber and thermoplastic rubber—Determination of dynamic properties—General guidelines”.
The dimensions of the test piece were as follows when using silicone rubber or urethane rubber and when using silicone gel or gelatin.
Silicone rubber or urethane rubber test piece: diameter of about 3 mm × height of about 3 mm.
Silicone gel or gelatin test piece: about 6 mm in diameter x about 5 mm in height.

  The entity model of the present invention is useful for surgical simulation in the medical field.

1A: 1A ′: 1B: 1C: 1D: 1E: 1F: 1G: 1H: surface layer 2A: 2A ′: 2B: 2C: 2D: 2E: 2F: 2G: 2H: lower layer 5I: 5J: 5K: tumor 6A ′ : Deep layer 10A: 10A ': 10B: 10C: 10D: 10E: 10F: 10G: 10H: Substantive model 10I: 10J: 10K: Substantive model with tumor 100: Lower mold 101: Molded surface 110: 120: Upper mold 111: 121: Molding surface

Claims (25)

A surface layer made of an elastic material; and a lower layer made of an elastic material arranged adjacent to the surface layer and having an elastic modulus different from that of the elastic material constituting the surface layer;
3D entity model including   The three-dimensional entity model according to claim 1, wherein the three-dimensional entity model has a shape equivalent to a human body part.   The elastic modulus of the elastic material constituting the surface layer and that of the elastic material constituting the lower layer are such that the elastic modulus when pressed from the surface layer toward the lower layer is directed from the surface of the human body part to the inside. The three-dimensional entity model according to claim 2, wherein the three-dimensional model is adjusted so as to approximate an elastic modulus when pressed.   The three-dimensional entity model according to any one of claims 1 to 3, wherein both the elastic material constituting the surface layer and the elastic material constituting the lower layer are polymers.   The elastic modulus of the elastic material constituting the lower layer is in the range of 1 to 99.9% or 100.1 to 500% of the elastic modulus of the elastic material constituting the surface layer. The three-dimensional entity model described in Crab. The absolute value of the difference between the elastic modulus of the elastic material constituting the lower layer and the elastic modulus of the elastic material constituting the surface layer is 1.0 × 10 ^{4 to} 1.0 × 10 ⁶ Pa. The three-dimensional entity model in any one of -5. The three-dimensional entity model according to any one of claims 1 to 6, wherein an elastic modulus of the elastic material constituting the surface layer is 1.0 x 10 ^{4 to} 1.0 x 10 ⁶ Pa.   The three-dimensional substance model according to any one of claims 1 to 7, wherein the elastic material constituting the lower layer has an elastic modulus lower than that of the elastic material constituting the surface layer.   The three-dimensional substance model according to claim 8, wherein an elastic modulus of the elastic material constituting the lower layer is in a range of 1 to 80% of an elastic modulus of the elastic material constituting the surface layer. The absolute value of the difference between the elastic modulus of the elastic material constituting the lower layer and the elastic modulus of the elastic material constituting the surface layer is 5.0 × 10 ^{4 to} 1.0 × 10 ⁶ Pa. Or the three-dimensional entity model of 9.   The said three-dimensional entity model has a shape equivalent to a human body part selected from the group consisting of a breast, an organ, a lip, an outer nose, an eyelid, and a face. The described 3D entity model. The elastic material constituting the surface layer is silicone rubber or polyurethane rubber,
The elastic material constituting the lower layer is silicone rubber, silicone gel or gelatin,
The three-dimensional entity model according to any one of claims 8 to 11, wherein the three-dimensional entity model has a shape equivalent to a breast.   The three-dimensional substance model according to any one of claims 1 to 7, wherein the elastic material constituting the lower layer has an elastic modulus higher than that of the elastic material constituting the surface layer.   The three-dimensional entity model according to claim 13, wherein an elastic modulus of the elastic material constituting the lower layer is within a range of 101 to 500% of an elastic modulus of the elastic material constituting the surface layer. The absolute value of the difference between the elastic modulus of the elastic material constituting the lower layer and the elastic modulus of the elastic material constituting the surface layer is 1.0 × 10 ^{5 to} 1.0 × 10 ⁶ Pa. Or the three-dimensional entity model of 14.   The three-dimensional entity model according to any one of claims 13 to 15, wherein the three-dimensional entity model has a shape equivalent to an auricle. The elastic material constituting the surface layer is silicone rubber or polyurethane rubber,
The three-dimensional substance model according to any one of claims 13 to 16, wherein the elastic material constituting the lower layer is silicone rubber or polyurethane rubber.   The three-dimensional entity model according to claim 1, wherein the three-dimensional entity model is used for a surgical simulation.   The three-dimensional entity according to claim 18, wherein the surgical simulation is performed for the purpose of practicing surgery to improve a doctor's surgical skill, planning an operation plan for smoothly performing the operation, or explaining the operation to a patient. model. A method for producing a three-dimensional entity model according to any one of claims 1 to 19,
A step of curing a resin composition for forming a surface layer containing a curable material by a casting method to form a surface layer; and a resin composition for forming a lower layer containing a curable material by a casting method to cure a lower layer Forming a step;
Including
The method of controlling the elastic modulus of the surface layer and the lower layer by adjusting the curing conditions of the surface layer and the lower layer. A method for producing a three-dimensional entity model according to any one of claims 1 to 19,
A step of curing a resin composition for forming a lower layer containing a curable material by a casting method to form a lower layer; and a resin composition for forming a surface layer containing a curable material on the surface of the lower layer by a lamination method. Curing to form a surface layer;
Including
The method of controlling the elastic modulus of the surface layer and the lower layer by adjusting the curing conditions of the surface layer and the lower layer. A method for producing a three-dimensional entity model according to any one of claims 1 to 19,
A step of curing a resin composition for forming a surface layer containing a curable material on the surface of a salt mold by a lamination method, removing the salt mold to form a hollow surface layer; and the hollow surface by an injection method Injecting the material constituting the lower layer into the layer to form the lower layer;
Including
The method of controlling the elastic modulus of the surface layer by adjusting the curing conditions of the surface layer. The three-dimensional entity model further includes a deep layer disposed on a side opposite to the surface layer side of the lower layer,
The three-dimensional substance model according to any one of claims 1 to 19, wherein the deep layer is made of a substance in a liquid state at 25 ° C. A method for producing a three-dimensional entity model according to claim 23,
A step of forming a lower layer by curing a lower layer forming resin composition containing a curable material on a salt-type surface by a lamination method;
A step of curing a resin composition for forming a surface layer containing a curable material on the surface of the lower layer by a lamination method to form a surface layer and removing the salt mold to obtain a hollow laminate; and an injection method Injecting the liquid substance into the hollow laminate to form a deep layer;
Including
The method of controlling the elastic modulus of the surface layer and the lower layer by adjusting the curing conditions of the surface layer and the lower layer.   The curing conditions include the mixing ratio of the curing agent and the solvent in the resin composition for forming the surface layer and the resin composition for forming the lower layer, and the heating temperature, heating time, and irradiation amount for curing the surface layer and the lower layer. The method for producing a three-dimensional entity model according to claim 20, 21, 22 or 24, wherein the one or more conditions are selected from the group consisting of: