WO2022176118A1

WO2022176118A1 - Biological model

Info

Publication number: WO2022176118A1
Application number: PCT/JP2021/006160
Authority: WO
Inventors: 信圭山中
Original assignee: 朝日インテック株式会社
Priority date: 2021-02-18
Filing date: 2021-02-18
Publication date: 2022-08-25
Also published as: JPWO2022176118A1

Abstract

This biological model comprises: a skin model that constitutes a portion including the surface of the biological model, and that simulates skin; a fascia/muscle model that simulates tissues including fascia and muscles; a joining part that comprises a porous body and joins the skin model and the fascia/muscle model; and a blood vessel model that is embedded in the fascia/muscle model.

Description

biological model

The present disclosure relates to biological models.

Conventionally, various biological models are known. Such a biological model is used, for example, in training for improving various skills related to treatment and diagnosis. For example, Patent Literature 1 discloses a biological model having a structure simulating skin, tissue, and blood vessels for simulating insertion of an injection needle into a blood vessel under ultrasound guidance. Further, Patent Literature 2 discloses a biological model for pressure ulcer diagnosis training using an ultrasonic examination apparatus.

JP 2010-533025 A JP 2016-224396 A

Among such biological models, in particular, biological models used for training of procedures related to puncture of inserting an injection needle into a blood vessel, and procedures related to treatment and diagnosis performed by inserting a medical device such as a catheter into a blood vessel, Sensation and feel obtained when inserting a medical device or the like are important for improving the quality of training. Therefore, there has been a demand for a biological model that enables training that provides a feel and sensation that is closer to that of a living body.

The present disclosure can be implemented as the following forms.
(1) According to one aspect of the present disclosure, a biological model is provided. This biological model includes a skin model that simulates skin by forming a portion including the surface of the biological model, a fascia/muscle model that simulates tissues including fascia and muscle, and a porous body, wherein the skin is A joint for joining the model and the fascia/muscle model, and a blood vessel model that is embedded in the fascia/muscle model and simulates a blood vessel.
According to this form of the biological model, the joints are composed of a porous body. Therefore, at least one of the skin model and the fascia/muscle model can be joined via the joint by the constituent material entering the pores of the porous body that constitutes the joint. It becomes possible to increase the bonding strength between the skin model and the fascia/muscle model. As a result, the limitation caused by the difficulty of joining when directly joining the skin model and the fascia/muscle model is suppressed, and the materials that make up the skin model and the materials that make up the fascia/muscle model can be Any combination can be selected. In this way, a skin model and a fascia/muscle model can be constructed using materials having desired properties. It becomes possible to obtain a closer sense of immersion.

(2) In the biological model of the above aspect, the skin model contains a first resin, the fascia/muscle model contains a second resin different from the first resin, and the joint includes the The porous body may contain one of the first resin and the second resin. With such a configuration, the joint between the skin model or the fascia/muscle model containing one of the resins is facilitated, and the joint strength between the skin model and the fascia/muscle model is increased. can be further enhanced.

(3) In the biological model of the above aspect, the porous body included in the joint may have pores penetrating through the porous body in the thickness direction. With such a configuration, by filling the pores of the porous body with the other resin, it is possible to prevent air bubbles from remaining in the joint.

(4) In the biological model of the above aspect, the skin model includes a resin mesh arranged to extend along the surface, and the resin mesh is a resin that constitutes a part of the skin model other than the resin mesh. It may be made of a third resin that is harder. With such a configuration, for example, the soft feel of the skin can be reproduced by the resin that constitutes the part other than the resin mesh, and by further providing the resin mesh, the injection needle can be pierced into the skin and the skin can be felt. Since it is possible to improve the reproducibility of the feeling when breaking through the skin, the reproducibility of the skin by the skin model can be improved.

(5) In the biological model of the above aspect, the wires forming the resin mesh may have a diameter of 0.5 mm or less. With such a configuration, for example, even if the resin that constitutes the resin mesh is a resin that is relatively difficult to transmit ultrasonic waves, it is possible to secure ultrasonic waves that pass through the interior of the biological model. A biological model can preferably be used for training in .

(6) In the biological model of the above aspect, the skin model is divided into an upper layer including the surface and a lower layer laminated on the upper layer, and the lower layer is formed of an adhesive gel. may be With such a configuration, regardless of the type of constituent material of the upper layer, it is possible to easily join the lower layer and the upper layer by utilizing the adhesiveness of the gel that constitutes the lower layer. The degree of freedom in material selection can be increased.

The present disclosure can be implemented in various forms other than those described above, for example, it can be implemented in the form of a biological model manufacturing method, a human body simulation device including a biological model, and the like.

BRIEF DESCRIPTION OF THE DRAWINGS Sectional drawing which represents typically the schematic structure of the biological model of 1st Embodiment. A flow chart showing a manufacturing method of a living body model. Sectional drawing which represents typically the schematic structure of the biological model of 2nd Embodiment. Sectional drawing which represents typically a schematic structure of the biological model of 3rd Embodiment. Sectional drawing which represents typically schematic structure of the biological model of 4th Embodiment. Sectional drawing which represents typically schematic structure of the biological model of 5th Embodiment. Sectional drawing which represents typically the schematic structure of the biological model of 6th Embodiment.

A. First embodiment:
(A-1) Overall configuration of biological model:
FIG. 1 is a cross-sectional view schematically showing the schematic configuration of the biological model 10 of the first embodiment. The biological model 10 of the present embodiment is used for training of procedures related to puncture of inserting an injection needle into a blood vessel, procedures related to treatment and diagnosis performed by inserting a medical device such as a catheter or a guide wire into a blood vessel, or medical treatment. It is used for purposes such as the development of electronic devices. In particular, the biological model 10 of the present embodiment is used for training of the above-described techniques under ultrasound guidance.

The biological model 10 includes a skin model 20, joints 30, a fascia/muscle model 40, a blood vessel model 50, and a bone model 60. In the biological model 10 , a skin model 20 , a joint 30 , and a fascia/muscle model 40 are layered in this order from the surface side of the biological model 10 . XYZ axes orthogonal to each other are illustrated in FIG. 1 and each figure after FIG. 3 to be described later. The X-axis direction and the Y-axis direction correspond to the horizontal direction when the biological model 10 is arranged, and the Z-axis direction corresponds to the vertical direction when the biological model 10 is arranged. However, the biological model 10 may be arranged in a different orientation. Also, the Y-axis direction corresponds to the longitudinal direction, which is the direction in which the blood vessel model 50 extends within the biological model 10 . It should be noted that FIG. 1 does not accurately represent the dimensional ratio of each part.

(A-2) Skin model:
The skin model 20 constitutes a portion including a surface 21, which is the surface of the biological model 10, and simulates the skin of the biological body. The skin model 20 of this embodiment includes a surface layer model 22 including a surface 21 that is the surface of the biological model 10, and a subcutaneous tissue model layered on the surface layer model 22 and provided below the surface layer model 22 (-Z direction side). 24 and. The superficial layer model 22 simulates the epidermis including the stratum corneum and the dermis. Subcutaneous tissue model 24 simulates subcutaneous tissue. The surface layer model 22 is also called "upper layer", and the subcutaneous tissue model 24 is also called "lower layer".

It is desirable that the surface model 22 provides a feel similar to that obtained when the skin of a living body is used as a touch when an injection needle or the like is pierced into the living body model 10 during training using the living body model. . In addition, when performing training under echo guidance, it is desirable that ultrasonic waves sufficiently pass through the surface layer model 22, that is, that the acoustic impedance is relatively low. Therefore, the material constituting the skin model 20 is selected and the thickness of the skin model 20 is selected so that a touch similar to that of the skin of a living body can be obtained at the time of puncture or the like, and ultrasonic waves can sufficiently penetrate the skin model 20. should be set.

The surface layer model 22 is configured by using, for example, an elastomer such as polyurethane, silicone, nylon, or polystyrene, natural rubber, or synthetic rubber, using these polymer materials alone, or by combining a plurality of polymer materials. can do. Physical properties such as frictional characteristics and elastic modulus are improved from the standpoint that it is easy to obtain a feel close to that of the skin of a living body (touch, elasticity felt when an echo observation probe is pressed against it, and how the probe slides). Polyurethanes are desirable, and flexible polyurethanes are particularly desirable, for consideration.

The thickness of the surface layer model 22 can be, for example, about 0.5 mm to 1.0 mm from the viewpoint that it is easy to obtain a touch similar to that of the skin of a living body when touching or puncturing. With such a thickness, when the biological model 10 is used under echo guidance, it is possible to sufficiently transmit ultrasonic waves through the surface layer model 22. can be used without any problems. However, the thickness of the surface layer model 22 is not limited to the above range.

In the subcutaneous tissue model 24, constituent materials are used so as to improve the reproducibility of the feel of the skin of a living body and to allow ultrasonic waves to sufficiently pass through the subcutaneous tissue model 24 when performing training under echo guidance. can be selected as appropriate. The subcutaneous tissue model 24 can be configured using gel such as silicone gel or polyurethane gel, for example. When the subcutaneous tissue model 24 is constructed using, for example, an adhesive polyurethane gel, the adhesiveness of the subcutaneous tissue model 24 is used regardless of the type of polymeric material that constitutes the surface model 22. It is desirable because the subcutaneous tissue model 24 and the surface layer model 22 can be easily joined. When the subcutaneous tissue model 24 does not have sufficient adhesiveness, the surface layer model 22 and the subcutaneous tissue model 24 are directly bonded to each other without using an adhesive or the like. It is desirable to be made of the same kind of polymer material. When using the same kind of polymer material, for example, by applying the material of the surface layer model 22 on the subcutaneous tissue model 24 and hardening it, covalent bonds, hydrogen bonds, etc. can be formed, and the two can be easily adhered to each other. By bringing the subcutaneous tissue model 24 and the surface layer model 22 into close contact with each other, it is possible to prevent air bubbles from entering between the subcutaneous tissue model 24 and the surface layer model 22, for example.

In addition, in the skin model 20, the portion including the surface 25, which is the surface on the side away from the surface 21, which is the surface of the biological model 10, that is, the resin contained in the subcutaneous tissue model 24 is also called "first resin".

(A-3) Fascia/muscle model:
The fascia/muscle model 40 is provided on the lower side (-Z direction side) of the skin model 20 and simulates tissues including fascia and muscles. In the fascia/muscle model 40, the constituent material may be appropriately selected so as to improve the reproducibility of the hardness of the tissue including the fascia and muscle of the living body. In addition, the fascia/muscle model 40 has a relatively low acoustic impedance so as to ensure visibility under echo guidance and improve the reproducibility of ultrasound images of tissues including fascia and muscles of a living body. It is only necessary to select the material of construction. From this point of view, it is desirable to use gel as the constituent material of the fascia/muscle model 40 . In particular, a hydrogel whose dispersion medium is water is desirable because it easily transmits ultrasonic waves and has good reproducibility of ultrasonic images.

Hydrogels used to construct the fascia/muscle model 40 include, for example, agarose gels, methylcellulose gels, hyaluronic acid hydrogels, alginate hydrogels, carboxymethylcellulose gels, and polysaccharide hydrogels such as xanthan gum. . Also, protein hydrogels containing collagen, gelatin, albumin, keratin, etc., synthetic polymer hydrogels containing polyethylene glycol (PEG), polylactic acid, polyacrylic acid, etc., polyvinyl alcohol (PVA) hydrogels, Silicone hydrogels may also be used. Alternatively, urethane gel, which is a polymeric material other than hydrogel, can also be suitably used as a constituent material of the fascia/muscle model 40 . Among the polymer materials described above, polyvinyl alcohol (PVA) hydrogel is easy to handle and has excellent reproducibility of the hardness of tissues including fascia and muscles of the living body and reproducibility of ultrasonic images. desirable.

The fascia/muscle model 40 may be configured by combining a plurality of arbitrary polymer materials among the various polymer materials described above. Acoustic impedance in the fascia/muscle model 40 can be adjusted by mixing and using a plurality of polymer materials. For example, when constructing the fascia/muscle model 40 using urethane gel, a desired ultrasonic image can be obtained by further mixing silicone gel to increase the acoustic impedance and adjusting the mixing ratio of the silicone gel. may be

The fascia/muscle model 40 may further contain an inorganic material in addition to the polymer material described above. Examples of inorganic materials mixed in the fascia/muscle model 40 include cellulose nanofibers and glass beads. By mixing these inorganic materials with relatively high acoustic impedance, the acoustic impedance of the entire fascia/muscle model 40 can be increased, and the ultrasonic image of the fascia/muscle model 40 can be made whiter. The fascia/muscle model 40 can be made harder. Adjust at least one of the type and concentration of the polymer material constituting the fascia/muscle model 40, the type of inorganic material added to the polymer material, the mixing ratio of the inorganic material, the particle size of the inorganic material, and the like. By doing so, it is possible to improve the reproducibility of the hardness of tissue including the fascia and muscle of the living body and the reproducibility of the ultrasonic image. In order to homogenize the ultrasonic image and hardness of the fascia/muscle model 40, the inorganic material may be fine particles having a particle size of about 10 nm to several hundred nm, for example. Also, by laminating a plurality of layers of mixed inorganic materials with different types and concentrations, an ultrasonic image of muscle as an aggregate of muscle fibers may be simulated.

The above-described polymer material that constitutes the fascia/muscle model 40 is a resin different from the already-described "first resin" that constitutes the skin model 20, and is also called a "second resin". The second resin may be composed of a plurality of types of resin.

(A-4) Joint:
The joint part 30 is arranged between the skin model 20 and the fascia/muscle model 40 so as to be in contact with the skin model 20 and the fascia/muscle model 40 to connect the skin model 20 and the fascia/muscle model 40 together. Join. The joint portion 30 of the present embodiment is configured by a foam containing the second resin, which configures the fascia/muscle model 40 and is described above. For example, when forming the fascia/muscle model 40 using polyvinyl alcohol (PVA) hydrogel, the joint 30 may be provided with foamed polyvinyl alcohol (foamed PVA). Further, for example, when the fascia/muscle model 40 is formed using silicone hydrogel, the joint 30 may be provided with foamed silicone. At this time, since the second resin forming the portion including the interface with the skin model 20 in the joint 30 is different from the first resin forming the portion including the interface with the joint 30 in the skin model 20, the joint A difference in acoustic impedance occurs at the interface between 30 and skin model 20, and the boundary between joint 30 and subcutaneous tissue model 24 can be easily visually recognized in the ultrasound image.

In the present embodiment, on the fascia/muscle model 40, a resin of the same type as the second resin that constitutes the fascia/muscle model 40 is used to perform foaming and curing steps to form the joint 30. The fascia/muscle model 40 and the joint 30 are joined. The manner in which the fascia/muscle model 40 and the joint 30 are joined may differ depending on the second resin used. For example, when polyvinyl alcohol (PVA) is used as the second resin, the fascia/muscle model 40 is formed by curing the foamed polyvinyl alcohol on the fascia/muscle model 40 containing the polyvinyl alcohol hydrogel. Physical cross-linking due to hydrogen bonding is formed between the constituting polyvinyl alcohol and the polyvinyl alcohol constituting the foam as the cross-linking cures, and the fascia/muscle model 40 and the joint portion 30 are joined. Further, for example, when silicone is used as the second resin, the silicone that forms the fascia/muscle model 40 is cured by curing the foamed silicone resin on the fascia/muscle model 40 containing silicone hydrogel. Condensation reaction progresses between the resin and the silicone resin that constitutes the foam as the cross-linking cures, and the fascia/muscle model 40 and the joint portion 30 are joined. As described above, the reaction accompanying the cross-linking hardening of the joint 30 progresses between the resin forming the fascia/muscle model 40 and the resin forming the joint 30, whereby the fascia/muscle model 40 and At the portion where the joint portion 30 is in contact, a layer in which the resin common to both is dissolved is formed. In order to increase the joint strength between the joint 30 and the fascia/muscle model 40, it is desirable that the joint 30 and the fascia/muscle model 40 share a high ratio of constituent materials. It is more desirable to be formed of a resin of composition.

In the foam provided in the joint part 30 , bubbles are opened on the surface 31 that is the surface that contacts the skin model 20 , that is, on the interface with the skin model 20 . In the portion including the interface with the skin model 20 , the first resin forming the skin model 20 , that is, the resin forming the subcutaneous tissue model 24 enters inside the bubbles of the foam forming the joint 30 . there is As described above, part of the subcutaneous tissue model 24 enters the foam cells that form the joint 30 , so that the skin model 20 and the joint 30 are joined by the anchor effect.

When forming the joint 30 on the fascia/muscle model 40, the constituent material of the joint 30 containing the second resin (for example, the same material as the material of the gel that constitutes the fascia/muscle model 40) After mixing the foaming agent and applying the mixed material onto the fascia/muscle model 40, the material may be foamed and hardened. Examples of foaming agents include low boiling point solvents such as normal pentane (n-pentane), cyclopentane, isopentane, normal butane, isobutane and propane. By appropriately setting conditions such as the type of foaming agent, the mixing ratio when the foaming agent is mixed with the polymer material constituting the joint 30, and the temperature during foaming and curing, the pores in the resulting foam can be adjusted. The size, porosity, ratio of open cells and closed cells, etc. can be adjusted. Further, when forming the foam, in addition to the foaming agent, other substances such as a surfactant may be mixed.

In order to open air bubbles at the interface with the skin model 20 in the joint 30, it is desirable that the ratio of closed air bubbles is small. In addition, if closed air bubbles are present in the joint 30, when the biological model 10 is observed using ultrasonic waves, the ultrasonic waves are reflected by the closed air bubbles, which may cause attenuation of the ultrasonic waves. It is desirable that there are few closed cells inside. It is desirable that the thickness of the joint portion 30 is, for example, 1.5 mm or more and 10 mm. Moreover, it is desirable that the average value of the bubble diameters formed in the joint portion 30 is 0.5 mm or more and 5 mm or less. By adjusting the conditions related to foaming and curing so as to obtain such a foam, the shape of the joint 30 is made into a shape in which the cells open at the interface with the skin model 20, thereby suppressing the formation of closed cells. becomes easier. Further, after the foaming process for forming the joint portion 30 is completed, for example, by crushing the bubbles formed by the foaming to increase the voids, the foam is converted to a porous body with an open cell structure, that is, the thickness A porous body having pores penetrating in the direction may be used. Alternatively, a plurality of gel materials mixed with different foaming agents are prepared, and these gel materials are stacked in order on the fascia/muscle model 40, foamed and cured to form joints having open cells. 30 may be formed.

(A-5) Blood vessel model:
The blood vessel model 50 is embedded in the fascia/muscle model 40, simulates a blood vessel, and is composed of a flexible tubular member. In the blood vessel model 50, the constituent materials may be appropriately selected so as to improve the reproducibility of the hardness of the blood vessels of the living body and the feeling when a medical device such as an injection needle or a catheter is inserted into the blood vessel. In addition, in the blood vessel model 50, the acoustic impedance is relatively low and the fascia/muscle model 40 has a relatively low acoustic impedance so that an injection needle and a medical device inserted into the blood vessel model 50 can be visually recognized under echo guidance. A constituent material having a relatively small difference from the acoustic impedance of the constituent material may be appropriately selected. As the polymer material that constitutes the blood vessel model 50, for example, it is possible to appropriately select and use from the materials described as the constituent materials of the fascia/muscle model 40. FIG. Among these materials, polyvinyl alcohol (PVA) is desirable because its lubricity and elasticity are similar to those of living blood vessels. Further, if the blood vessel model 50 is made of the same material as the fascia/muscle model 40, it is desirable because it facilitates securing of the joint strength between the blood vessel model 50 and the fascia/muscle model 40. FIG.

Similar to the fascia/muscle model 40, the blood vessel model 50 contains an inorganic material in addition to a polymer material such as hydrogel, thereby improving the reproducibility of the hardness of the living body and the reproducibility of the ultrasonic image. can be improved. The blood vessel model 50 may be a single-layer tubular member made of a homogeneous material, or may be a tubular member in which a plurality of layers of mixed inorganic materials with different types and concentrations are laminated. As a result, a blood vessel having an intima, a media, and an adventitia can be simulated.

(A-6) Bone model:
The bone model 60 is embedded in the fascia/muscle model 40 to simulate a bone. The bone model 60 may be made of a relatively hard material that exhibits an elastic modulus close to that of a living bone. Examples of constituent materials of the bone model 60 include acrylic resin, polycarbonate, polyethylene terephthalate (PET), and polyvinyl chloride (PVC). In the bone model 60 located deeper in the biological model 10 than the blood vessel model 50, it is not necessary to ensure the visibility under echo guidance, but it is desirable not to reflect ultrasonic waves excessively. Further, when it is desired to ensure the visibility of the bone model 60 in an ultrasonic image, a layer made of a material having a larger acoustic impedance difference with the fascia/muscle model 40 is added to the surface of the bone model 60. may be provided.

By providing the bone model 60, when training is performed by inserting an injection needle or a medical device into the blood vessel model 50, for example, it is possible to simulate the influence of the bones existing near the blood vessel on the feeling during operation. can be done. However, the bone model 60 is not essential, and the bone model 60 may not be provided in the biological model 10 in which the target of the procedure to be trained is a blood vessel.

(A-7) Method for producing biological model:
FIG. 2 is a flow chart showing a method for manufacturing the biological model 10. As shown in FIG. When manufacturing biological model 10, first, blood vessel model 50 and bone model 60 are produced (step T100). The blood vessel model 50 and the bone model 60 may be produced by curing the above-described polymeric material as the constituent material in a mold having a shape corresponding to each shape.

Next, the blood vessel model 50 and the bone model 60 produced in step T100 are placed in a molding mold having a shape corresponding to the overall shape of the biological model 10 (step T110). Then, after filling the molding mold with the constituent material of the fascia/muscle model 40, the filled constituent material is gelled to form the fascia/muscle model 40 (step T120). For example, when the fascia/muscle model 40 is made of polyvinyl alcohol (PVA), the polyvinyl alcohol is dissolved in water or an aqueous solution containing a water-soluble organic solvent such as dimethylsulfoxide to form a polyvinyl alcohol solution. make. At this time, if necessary, other components such as inorganic materials are further added, heated to about 80 to 130° C., mixed, and filled in the molding mold described above. After that, the polyvinyl alcohol solution is cooled to about −30° C., whereby the polyvinyl alcohol molecules are crosslinked and cured. Then, by returning the cooled polyvinyl alcohol solution to room temperature, a polyvinyl alcohol gel is obtained and the fascia/muscle model 40 is formed.

For example, when both the fascia/muscle model 40 and the blood vessel model 50 are formed using polyvinyl alcohol, in step T120, a heated polyvinyl alcohol solution is applied to a molding mold in which the blood vessel model 50 and the bone model 60 are arranged. It should be filled inside. As a result, the surface temperature of the blood vessel model 50 rises and the hydrogen bonds of the polyvinyl alcohol molecules are broken, so that the surface of the blood vessel model 50 partially dissolves and mixes with the polyvinyl alcohol solution filled in the molding mold. After that, the entire molding mold is frozen, and the polyvinyl alcohol molecules are cross-linked to bond the blood vessel model 50 and the fascia/muscle model 40 .

After the fascia/muscle model 40 is formed in step T120, the constituent material of the joint 30 is next applied onto the fascia/muscle model 40 (step T130). When the fascia/muscle model 40 and the joint 30 are formed using polyvinyl alcohol, in step T130, for example, the above-described gel material used to form the fascia/muscle model 40 in step T120 is used. A foaming agent may be added to the same material as .

After that, the constituent material of the joint 30 applied in step T130 is foamed (step T140). In step T140, the temperature may be raised to a temperature at which foaming by the foaming agent proceeds. For example, when n-pentane is used as the foaming agent, the temperature may be raised to about 50.degree.

After foaming the constituent material of the joint portion 30 in step T140, the cells opened on the surface of the resulting foam layer are filled with the material of the subcutaneous tissue model 24 to gel (step T150). In step T150, the liquid material for forming the subcutaneous tissue model 24 is poured onto the foam layer to fill the cells of the foam layer with the liquid material, but the natural degassing of the cells is insufficient. Vacuum degassing may be performed if natural degassing is difficult. In step T150, it is desirable to fill the material of the subcutaneous tissue model 24 without leaving air in the bubbles. In step T150, after filling the material of the subcutaneous tissue model 24 in the cells of the foam layer, the material of the subcutaneous tissue model 24 is crosslinked and cured under temperature conditions (for example, room temperature) according to the material of the subcutaneous tissue model 24. gel to form a subcutaneous tissue model 24 .

Next, a member that will become the surface layer model 22 is prepared (step T160). Here, a sheet made of the polymer material already described as the material of the surface layer model 22 is prepared. Then, the prepared member to be the surface layer model 22 is pasted onto the subcutaneous tissue model 24 formed in step T150 (step T170) to complete the living body model 10. FIG. For example, when the subcutaneous tissue model 24 is made of an adhesive polyurethane gel, the adhesiveness of the subcutaneous tissue model 24 can be used to bring the surface layer model 22 into close contact with the subcutaneous tissue model 24 without gaps. When the subcutaneous tissue model 24 is made of a non-adhesive polymer material, for example, the same material as that of the subcutaneous tissue model 24 is used instead of steps T160 and T170. The subcutaneous tissue model 24 and the surface layer model 22 may be joined by performing a step of applying the constituent material to the subcutaneous tissue model 24 and a step of curing the applied constituent material to form the surface layer model 22. .

The biological model 10 can have various shapes such as a rectangular parallelepiped block shape and a cylindrical shape. Alternatively, depending on the type of blood vessel to be trained for a procedure involving insertion of an injection needle or medical device, a model that imitates the shape of a part of the human body having the blood vessel, such as a leg or an arm, may be used. Alternatively, a model simulating a wider range of the human body, such as a human body model, may be used. FIG. 1 shows an enlarged view of only a part of the biological model 10 thus produced, which includes a blood vessel model 50 to be trained and a skin model 20 in the vicinity thereof.

According to the biological model 10 of this embodiment configured as described above, the joint 30 that joins the skin model 20 and the fascia/muscle model 40 is made of a resin foam. Therefore, by firmly joining the skin model 20 and the joining portion 30, the joining strength between the skin model 20 and the fascia/muscle model 40 can be increased. This is because, for example, the resin forming the skin model 20 penetrates into the cells of the foam forming the joint 30, thereby obtaining an anchor effect. As a result, the restriction due to the difficulty of joining when directly joining the skin model 20 and the fascia/muscle model 40 is suppressed, and the materials that make up the skin model and the materials that make up the fascia/muscle model are combined. , and high connection strength can be obtained between the skin model and the fascia/muscle model.

In particular, in the present embodiment, since the joint 30 and the fascia/muscle model 40 are formed using the same kind of resin, for example, the resin that becomes the joint 30 is cross-linked and cured on the fascia/muscle model 40. By applying the same kind of resin material, the same kind of resin materials can be easily bonded. Therefore, regardless of the constituent materials of the skin model 20 and the fascia/muscle model 40, the strength of the joint between the skin model 20 and the fascia/muscle model 40 via the joint 30 can be further increased.

In this way, even if the skin model 20 and the fascia/muscle model 40 are made of different materials, they can be well joined together. Materials can be set arbitrarily. For example, in the skin model 20, it is desirable to use a material that has a frictional characteristic and an elastic modulus that can improve the reproducibility of the feel when touching the skin. Furthermore, when puncture training is performed using the biological model 10, it is desirable that the skin model 20 uses a material having a hardness and an elastic modulus that can improve the reproducibility of the feeling when the injection needle is pricked. be On the other hand, in the fascia/muscle model 40, it is desirable to use a material with high reproducibility of the hardness of tissue including fascia and muscle in a living body. Furthermore, when the biological model 10 is used for echo-guided training, the fascia/muscle model 40 sufficiently transmits ultrasonic waves to achieve excellent reproducibility of ultrasonic images in the living body. It is preferable to use a gel. In this way, when selecting the constituent materials of the skin model 20 and the fascia/muscle model 40, the combination of the skin model 20 and the fascia/muscle model 40 is not restricted due to difficulty in joining. The skin model 20 and the fascia/muscle model 40 can be satisfactorily joined while appropriately selecting the constituent materials of and according to the required performance.

For each part constituting the biological model 10, when the constituent materials of each part are selected so as to enhance the reproducibility of the part of the living body simulated by each part, the biological model 10 as a whole has performance related to reproducibility such as hardness and touch. In order to obtain a sufficient result, it is important that each part simulating a plurality of tissues is connected with appropriate strength. In this embodiment, by providing the joint portion 30, sufficient joint strength can be obtained. Moreover, when the skin model 20 and the fascia/muscle model 40, which are made of different materials, are layered without providing a structure for bonding, the bonding strength between the two will be insufficient. As a result, air bubbles, for example, may occur between the skin model 20 and the fascia/muscle model 40 . When air bubbles are generated between the skin model 20 and the fascia/muscle model 40, the air bubbles interfere with the transmission of ultrasonic waves, making it difficult to observe the site including the blood vessel model 50 below the air bubbles with an ultrasonic image. can be. In this embodiment, by providing the joint portion 30, it is possible to suppress the above-described inconvenience caused by insufficient joint strength.

In the present embodiment, it is desirable that the foam included in the joint 30 has pores penetrating through the foam in the thickness direction. The "pores penetrating the foam in the thickness direction" may be open cells composed of a plurality of cells communicating with each other so as to penetrate the foam in the thickness direction as a whole. It may be a single bubble that penetrates in a direction. Unlike the pores penetrating the foam, when closed cells are formed inside the joint 30, the resin constituting the skin model 20 does not enter the closed cells. , air bubbles remain in the joint 30 . If air bubbles remain in the joint portion 30, when the biological model 10 is used under echo guidance, the air bubbles hinder the transmission of ultrasonic waves, and the part including the blood vessel model 50 below the air bubbles can be observed with an ultrasonic image. can be difficult. If the pores of the foam are through-holes, the pores can be filled with the resin that constitutes the skin model 20 , thereby suppressing the formation of air bubbles in the joint 30 .

Furthermore, according to the present embodiment, since it is not necessary to use an adhesive to join the skin model 20 and the fascia/muscle model 40, the hardness of the biological model 10, for example, The hardness near the skin model 20 is not changed. Furthermore, when an adhesive layer is provided between the skin model 20 and the fascia/muscle model 40, the adhesive layer prevents the transmission of ultrasonic waves, and the blood vessel model in the layer below the adhesive layer. Sites containing 50 can be difficult to observe with ultrasound images. Therefore, when the biological model 10 is used for training of procedures performed under echo guidance, the effect of eliminating the need for an adhesive layer can be obtained particularly remarkably.

B. Second embodiment:
FIG. 3 is a cross-sectional view schematically showing the schematic configuration of the biological model 110 of the second embodiment. The second embodiment has the same configuration as the first embodiment except that a skin model 120 is provided instead of the skin model 20 of the first embodiment. In 2nd Embodiment, the same reference number is attached|subjected to the part which is common in the biological model 10 of 1st Embodiment.

The skin model 120 includes a surface layer model 122 and a subcutaneous tissue model 24. The surface layer model 122 includes a resin layer made of the same resin material as the material forming the surface layer model 22 of the first embodiment, and a resin mesh 126 embedded in this resin layer. The resin mesh 126 is made of resin that is harder than the resin that forms the resin layer, that is, the portion including the surface 21 . In the present embodiment, the resin mesh 126 is formed not only from the resin that forms the resin layer but also from a resin that is harder than the resin that forms the subcutaneous tissue model 24 . The resin that forms the resin mesh 126 is also called a "third resin".

As the resin forming the resin mesh 126, for example, polypropylene or polycarbonate can be used. The resin mesh 126 can be a woven fabric or a knitted fabric produced using strands made of the above-described third resin.

With such a configuration, since the resin mesh 126 is formed of the third resin that is harder than the resin constituting the parts other than the resin mesh 126 in the skin model 120, the reproducibility of the skin by the skin model 120 can be improved. can be done. For example, the resin constituting the resin layer described above can reproduce the soft feel of the skin, and the provision of the resin mesh 126 further improves the reproducibility of the feel when the injection needle pierces the skin and pierces the skin. can be enhanced. In this way, by appropriately selecting the constituent materials of each part of the skin model 120, the properties of the skin model 120 as a whole can be adjusted, so that the reproducibility of the skin by the skin model 120 can be further improved.

When forming the surface layer model 122 of the second embodiment, when the resin material is cross-linked and cured to form a resin layer, the resin mesh 126 is embedded in the resin material before curing arranged in layers, and then , cross-linking curing of the resin material may be performed. By embedding the resin mesh 126 in the resin material before curing, the resin mesh 126 is impregnated with the resin material that constitutes the resin layer. The resin mesh 126 can be satisfactorily bonded.

As described above, the wire diameter (average wire diameter) of the strands constituting the resin mesh 126 is set to, for example, 0.5 mm from the viewpoint of obtaining the effect of improving the reproducibility of the feeling of puncturing by the resin mesh 126, for example. It should be 1 mm or more. In addition, in the present embodiment, even if the resin constituting the resin mesh 126 is a resin that is relatively difficult to transmit ultrasonic waves, by ensuring the opening of the mesh and the ratio of the opening area in the mesh, the biological model Ultrasonic waves can be ensured to penetrate the interior of 110 . From the viewpoint of ensuring transmission of ultrasonic waves, the wire diameter of the strands of the resin mesh 126 can be set to, for example, 0.5 mm or less.

In the biological model 110 of the second embodiment, the surface model 122 is provided with the resin mesh 126, and the irregularities on the surface of the resin mesh 126 form irregularities on the surface 21, which is the surface of the biological model 110, and the surface of the skin. The reproducibility of touch may be further enhanced. For example, the unevenness formed on the surface (surface 21) of the surface layer model 22 is determined by the wire diameter of the wires of the resin mesh 126, the opening of the resin mesh 126, the depth at which the resin mesh 126 is arranged in the surface layer model 122, and the like. You can adjust the size.

C. Third embodiment:
FIG. 4 is a cross-sectional view schematically showing the schematic configuration of the biological model 210 of the third embodiment. The third embodiment has the same configuration as the second embodiment except that a skin model 220 is provided instead of the skin model 120 of the second embodiment. In 3rd Embodiment, the same reference number is attached|subjected to the part which is common in the biological model 10 of 2nd Embodiment.

A skin model 220 of the third embodiment includes a surface layer model 222 and a subcutaneous tissue model 24 . The surface layer model 122 of the second embodiment is formed by the resin layer and the resin mesh 126, but the surface layer model 222 of the third embodiment has the same shape as the resin mesh 126 of the second embodiment, and has subcutaneous tissue. It is composed only of a resin mesh formed of a resin harder than the resin forming the model 24 . For example, when the skin model 220 is formed, such a surface layer model 222 is formed by arranging a resin mesh on a layer made of the material of the subcutaneous tissue model 24 provided on the joint 30, and then placing the material of the subcutaneous tissue model 24. can be formed by cross-linking and curing. Even with such a configuration, the same effect as in the second embodiment can be obtained.

D. Fourth embodiment:
FIG. 5 is a cross-sectional view schematically showing the schematic configuration of the biological model 310 of the fourth embodiment. The fourth embodiment has the same configuration as the first embodiment except that a skin model 320 is provided instead of the skin model 20 of the first embodiment. In 4th Embodiment, the same reference number is attached|subjected to the part which is common in the biological model 10 of 1st Embodiment.

The skin model 320 of the fourth embodiment is made up of a single layer. Even with such a configuration, when the constituent material of the skin model 320 is selected so that the desired characteristics of the skin model 320 can be realized, by providing the joint 30, the skin model 320 and the fascia/muscle model 40 are formed. The effect of increasing the bonding strength with is obtained. The skin model has a two-layer structure as in the first embodiment, or a single layer as in the fourth embodiment, or may be formed by laminating a plurality of layers of three or more layers. may

E. Fifth embodiment:
FIG. 6 is a cross-sectional view schematically showing the schematic configuration of the biological model 410 of the fifth embodiment. The fifth embodiment has the same configuration as the first embodiment, except that a joint 430 is provided instead of the joint 30 of the first embodiment. In the fifth embodiment, parts common to the biological model 10 of the first embodiment are given the same reference numerals.

The joint portion 430 of the fifth embodiment is made of a foam containing the first resin that constitutes the subcutaneous tissue model 24 and is described above. In the fifth embodiment, the joint 430 and the skin model 20, which commonly contain the first resin, are joined by placing the other material on top of one and then cross-linking and curing the other. Also, the joint portion 430 and the fascia/muscle model 40 are joined by allowing the second resin forming the fascia/muscle model 40 to enter the pores of the joint portion 430 . Even with such a configuration, the same effect as in the first embodiment can be obtained.

F. Sixth embodiment:
FIG. 7 is a cross-sectional view schematically showing the schematic configuration of a biological model 510 of the sixth embodiment. The sixth embodiment has the same configuration as the first embodiment except that a joint 530 is provided instead of the joint 30 of the first embodiment. In 6th Embodiment, the same reference number is attached|subjected to the part which is common in the biological model 10 of 1st Embodiment.

In the sixth embodiment, the joint portion 530 and the skin model 20 are joined by allowing the first resin forming the subcutaneous tissue model 24 to enter the pores of the joint portion 530 . Similarly, the joint portion 530 and the fascia/muscle model 40 are joined together by filling the pores of the joint portion 530 with the second resin constituting the fascia/muscle model 40. . Such a living body model 510 is obtained, for example, by placing the constituent material of one of the subcutaneous tissue model 24 and the fascia/muscle model 40 on one surface of the joint 530 and then cross-linking and curing the material. The structure may be reversed, and the other constituent material of the subcutaneous tissue model 24 and the fascia/muscle model 40 may be placed on the other surface of the joint 530 and then cross-linked and cured.

Even with such a configuration, the same effects as in the first embodiment can be obtained. Further, according to the sixth embodiment, even if the constituent material of the joint 530 is different from the constituent materials of the skin model 20 and the fascia/muscle model 40, the skin model 20 and the fascia/muscle model The bonding strength with 40 can be increased. Further, according to the sixth embodiment, since the constituent material of the joint 530 can be made different from the constituent materials of both the skin model 20 and the fascia/muscle model 40, the selection of the constituent material of the joint 530 is It can increase the degree of freedom.

In the sixth embodiment, the constituent material of the joint portion 530 may include at least one of the first resin and the second resin. In this case, among the resins constituting the skin model 20 and the fascia/muscle model 40, the resin common to the joint 530 enters the pores of the joint 530, and the resin constituting the joint 530 can be fused with each other, the bonding strength can be further increased.

G. Other embodiments:
In each of the above-described embodiments, the joint portion is made of foam, but may be made of a porous material other than foam. For example, after forming a resin layer containing the second resin on the fascia/muscle model 40 and forming the joint 30, the resin layer is made porous by an irradiation etching method to form a porous body composed of the resin. It is good also as providing the joint part 30 provided. As described above, even when the joint is formed of a porous material different from the foam, the same effect of increasing the joint strength between the skin model and the fascia/muscle model can be obtained.

In each of the above-described embodiments, the biological model is used for training of procedures performed under echo guidance, but may have a different configuration. Even when used for training of procedures performed under conditions other than echo guidance, for example, materials for the skin model and fascia/muscle model 40 can be reproduced so that the feel of each part such as the skin surface and blood vessels can be reproduced. can increase the degree of freedom of choice when choosing By providing the connecting portion 30, the skin model and the fascia/muscle model 40, which are made of different materials, can be well connected.

The present disclosure is not limited to the above-described embodiments and the like, and can be implemented in various configurations without departing from the scope of the present disclosure. For example, the technical features in the embodiments corresponding to the technical features in the respective modes described in the Summary of the Invention column may be used to solve some or all of the above problems, or Substitutions and combinations may be made as appropriate to achieve part or all. Also, if the technical features are not described as essential in this specification, they can be deleted as appropriate.

10, 110, 210, 310, 410, 510... Living

body model

20, 120, 220, 320...

Skin model

21, 25, 31...

Surface

22, 122, 222... Surface layer model 24...

Subcutaneous tissue model

30, 430, 530... Junction 40 Fascia/muscle model 50 Blood vessel model 60 Bone model 126 Resin mesh

Claims

a biological model,
a skin model that simulates the skin by configuring a portion including the surface of the biological model;
a fascia/muscle model that simulates tissue containing fascia and muscle;
a joint portion that includes a porous body and joins the skin model and the fascia/muscle model;
a blood vessel model that is embedded in the fascia/muscle model and simulates a blood vessel;
a biological model.
The biological model according to claim 1,
The skin model contains a first resin,
The fascia/muscle model contains a second resin different from the first resin,
The biological model, wherein the porous body included in the joint includes one of the first resin and the second resin.
The biological model according to claim 1 or 2,
The biological model, wherein the porous body included in the joint has pores penetrating through the porous body in a thickness direction.
A biological model according to any one of claims 1 to 3,
The skin model comprises a resin mesh arranged to spread along the surface,
The biological model, wherein the resin mesh is made of a third resin that is harder than the resin that constitutes the part of the skin model other than the resin mesh.
The biological model according to claim 4,
The living body model, wherein the wires forming the resin mesh have a diameter of 0.5 mm or less.
A biological model according to any one of claims 1 to 5,
The skin model is divided into an upper layer including the surface and a lower layer laminated on the upper layer,
The biological model, wherein the lower layer is formed of an adhesive gel.