JP7343873B2 - biological model - Google Patents

Description

The technology disclosed herein relates to a biological model.

Percutaneous angioplasty (hereinafter referred to as ``PTA'') and percutaneous coronary angioplasty (hereinafter referred to as ``PTA'') are performed to restore blood flow at narrowed or occluded areas (hereinafter referred to as ``lesion'') in blood vessels. ``PTCA'') is widely used. Lesions are formed at various positions on blood vessels depending on individual differences and the period of formation. For PTA and PTCA (hereinafter referred to as "PTA, etc."), various techniques such as balloon dilation are employed.

The procedure using the balloon expansion method is performed, for example, by the following procedure. That is, a guide wire is inserted into a blood vessel, and the guide wire is pushed forward until it passes through a lesion within the blood vessel. Next, the balloon catheter is advanced to the lesion using the guidewire as a rail. Then, by expanding the balloon of the balloon catheter, the blood vessel wall at the affected area is pushed open from the inside. These procedures clear the path for blood and restore blood flow.

Techniques such as PTA require delicate operations from the operator, and the position and condition of a lesion in a blood vessel vary from patient to patient, so it is not easy to master techniques such as PTA. Therefore, various vascular lesion models including a simulated blood vessel that imitates a blood vessel and a simulated lesion area that imitates a lesion area have been proposed for use in training to improve procedures such as PTA (for example, see Patent Document 1). .

Furthermore, a technique using polyvinyl alcohol as a material for forming a blood vessel model has been proposed (see, for example, Patent Document 2).

Japanese Patent Application Publication No. 2018-132622 Japanese Patent Application Publication No. 2011-75907

A simulated blood vessel formed of polyvinyl alcohol has, for example, relatively high elasticity and flexibility (flexibility), and has properties similar to actual blood vessels. However, as mentioned above, the actual location of the lesion varies widely. For this reason, for example, a plurality of simulated blood vessels may be connected and the simulated blood vessels may be extended depending on the position of the lesion in the actual blood vessel. In such cases, a plurality of simulated blood vessels may be connected using an attachment such as a clamp. However, in a simulated blood vessel connected in this way, the elasticity and flexibility (flexibility) are reduced in the connected portion, so that the properties sufficiently approximate those of the actual blood vessel (relatively high elasticity and flexibility). It was difficult to simulate Thus, in order to sufficiently improve procedures such as PTA, it is desired to provide a vascular lesion model that connects a plurality of simulated blood vessels and is equipped with a simulated blood vessel that sufficiently approximates the actual blood vessel. .

The problem of not being able to sufficiently approximate actual blood vessels when connecting multiple simulated blood vessels is not limited to vascular lesion models used for training to improve procedures such as PTA. Common to vascular lesion models that include a simulated blood vessel that simulates a lesion and a simulated lesion that simulates a lesion, a vascular model that includes a simulated blood vessel, and a biological model that is constructed by connecting multiple members made of polyvinyl alcohol. This is an issue.

This specification discloses a technique that can solve the above-mentioned problems.

The technology disclosed in this specification can be realized, for example, as the following form.

(1) The biological model disclosed in this specification is a biological model, and includes a first member containing polyvinyl alcohol gel, and a second member joined to at least a portion of the first member. , a second member containing a gel of polyvinyl alcohol, and a first joint portion between the first member and the second member contains a chemically crosslinked gel. In this biological model, the first joint between the first part and the second part contains PVA gel. Therefore, the relatively high elasticity and flexibility of the PVA gel can be maintained even in the first joint portion. Therefore, according to this living body model, the first member containing PVA gel and the second member are firmly connected while having properties (relatively high elasticity and flexibility) that are sufficiently similar to those of an actual living body. It is possible to provide a biological model with

(2) In the biological model, the first member and the second member are each tubular, and the first joint portion is connected to one end in the longitudinal direction of the first member; It may be configured such that the second member is connected to one end in the longitudinal direction of the second member. According to this living body model, it is possible to provide a living body model in which the tubular first member and the second member are firmly connected without using other members.

(3) In the biological model, the first member and the second member are each tubular, and the first joint portion is located at one end of the first member in the longitudinal direction. The inner circumferential surface and the outer circumferential surface on one end side in the longitudinal direction of the second member may be a joined portion. According to this living body model, it is possible to provide a living body model in which the tubular first member and the second member are firmly connected without using other members. For example, by increasing the portion where the inner circumferential surface on one end side of the first member and the outer circumferential surface on one end side of the second member are joined (for example, by increasing the joint area), The bonding strength between the first member and the second member can be increased more effectively.

(4) The biological model includes a third member containing polyvinyl alcohol gel and having a tubular shape, the first member having a sheet shape, the second member having a tubular shape, and the third member having a tubular shape. A first outer circumferential surface on one end side in the longitudinal direction of the second member and a second outer circumferential surface on one end side in the longitudinal direction of the third member respectively refer to the first outer circumferential surface on the one end side in the longitudinal direction of the third member. The first bonding portion is a portion where the bonding surface of the first member and the first outer circumferential surface of the second member are bonded to each other. The second joint portion between the joint surface of the first member and the second outer circumferential surface of the third member may include a chemically crosslinked gel. According to the present biological model, it is possible to provide a biological model in which the tubular second member and the third member are firmly connected via the sheet-like first member. For example, by increasing the bonding surface of the first member, the bonding strength between the first member and the second member and between the first member and the third member can be increased, and in turn, the bonding strength between the first member and the second member and the first member and the third member can be increased. The bonding strength between the member and the third member can be increased more effectively.

(5) The biological model has a fourth member made of chemically crosslinked gel between the second member and the third member, and one of the fourth members the end is joined to the one end of the second member, and the other end of the fourth member is joined to the one end of the third member, The one end of the second member and the one end of the third member may each include a chemically crosslinked gel. According to this biological model, the tubular second member and third member, which are connected via the sheet-like first member, are connected via the fourth member made of chemically crosslinked gel. , it is possible to provide a more strongly connected biological model. Furthermore, the end of the second member that is joined to the fourth member and the end of the third member that is joined to the fourth member each contain a chemically crosslinked gel. Therefore, the bonding strength between the second member and the fourth member and between the third member and the fourth member can be increased, and in turn, the bonding strength between the second member and the third member can be increased. can be enhanced more effectively.

(6) In the biological model, the first member and the second member may be simulated blood vessels. According to this biological model, a blood vessel model is provided that includes a simulated blood vessel in which a first member (first partial simulated blood vessel) and a second member (second partial simulated blood vessel), which are simulated blood vessels, are firmly joined. can do.

(7) The biological model may include a simulated lesion part located in the hollow part of the simulated blood vessel and in a part in the longitudinal direction of the simulated blood vessel. According to this living body model, it is possible to provide a vascular lesion model that more closely resembles a living body that has a lesion formed in a portion of an actual blood vessel in the longitudinal direction.

Note that the technology disclosed in this specification can be realized in various forms, such as a biological model, a training kit including a biological model, a simulator including a biological model, and a manufacturing method thereof. It can be realized.

An explanatory diagram schematically showing the external configuration of the vascular lesion model 100 in the first embodiment FIG. 2 is an explanatory diagram showing an enlarged cross-sectional configuration of a portion of the vascular lesion model 100 (portion X1 in FIG. 1) in the first embodiment. It is a flow chart showing a manufacturing method of the vascular lesion model 100 in the first embodiment. FIG. 2 is an explanatory diagram conceptually showing a method for manufacturing a vascular lesion model 100 in the first embodiment. It is an explanatory view showing an enlarged cross-sectional configuration of a vascular lesion model 100a in a second embodiment. It is an explanatory view showing an enlarged cross-sectional configuration of a vascular lesion model 100b in a third embodiment. It is an explanatory view showing an enlarged cross-sectional configuration of a vascular lesion model 100c in a first modification. It is an explanatory view showing an enlarged cross-sectional configuration of a vascular lesion model 100d in a second modification. It is an explanatory view showing an enlarged cross-sectional configuration of a vascular lesion model 100e in a third modification.

A. First embodiment:
A-1. Configuration of vascular lesion model 100:
FIG. 1 is an explanatory diagram schematically showing the external configuration of a vascular lesion model 100 in the first embodiment, and FIG. 2 is an explanatory diagram schematically showing an XZ FIG. 2 is an explanatory diagram showing an enlarged cross-sectional configuration. Each figure shows mutually orthogonal XYZ axes for specifying directions. In this specification, for convenience, the Z-axis positive direction is referred to as an upward direction, and the Z-axis negative direction is referred to as a downward direction, but the vascular lesion model 100 is actually installed in a different direction from such an orientation. or may be used. The same applies to FIG. 4 and subsequent figures.

The vascular lesion model 100 is a device that simulates an actual blood vessel and a lesion. The vascular lesion model 100 is used alone, in combination with other simulated blood vessels, or as part of a training kit or simulator, for example, for training to improve procedures such as PTA. The vascular lesion model 100 includes a simulated blood vessel 110 and a simulated lesion 130. The vascular lesion model 100 is an example of a biological model in the claims.

The simulated blood vessel 110 is a member that simulates an actual blood vessel, and includes a first partial simulated blood vessel 10 and a second partial simulated blood vessel 20 joined to the first partial simulated blood vessel 10. Note that in FIGS. 1 and 2, illustration of a part (both ends) of the simulated blood vessel 110 is omitted. The first partial simulated blood vessel 10 is an example of a first member in the claims, and the second partial simulated blood vessel 20 is an example of a second member in the claims.

The first partial simulated blood vessel 10 has one end (hereinafter referred to as "first end 15"), the other end (not shown), and a first end in the longitudinal direction of the first partial simulated blood vessel 10. It has a central portion 17 of. Further, the second partial simulated blood vessel 20 has one end (hereinafter referred to as "second end 25") and the other end (not shown) in the longitudinal direction of the second partial simulated blood vessel 20. It has a second central portion 27. Note that the first central portion 17 is a portion of the first partial simulated blood vessel 10 other than the first end 15 and the other end (not shown), and the second central portion 27 is a portion of the first partial simulated blood vessel 10 that is other than the first end 15 and the other end (not shown). This is a portion of the partial simulated blood vessel 20 other than the second end 25 and the other end (not shown). The first end portion 15 is a portion including the first end surface S1, and the second end portion 25 is a portion including the second end surface S2. Here, the ends 15 and 25 are, for example, portions that are about 2 mm or more and 5 cm or less when viewed in the Z-axis direction.

In this embodiment, the vascular lesion model 100 includes a first joint portion 50 where a first partial simulated blood vessel 10 and a second partial simulated blood vessel 20 are joined. In other words, in this embodiment, the first joint portion 50 is a portion where the first end portion 15 and the second end portion 25 are joined. The first joint portion 50 will be described in detail later. The first joint portion 50 is an example of a first joint portion in the claims.

The first partial simulated blood vessel 10 and the second partial simulated blood vessel 20 each have a hollow part (inner hole) 12 and a hollow part (inner hole) 22, each having a tubular shape (e.g. circular tube shape), imitating an actual blood vessel. It is a member. The diameter DV of the hollow portions 12 and 22 in the partial simulated blood vessels 10 and 20 is, for example, approximately 1 mm or more and 30 mm or less. In this embodiment, the diameters of the hollow parts 12 and 22 of the partial simulated blood vessels 10 and 20 are substantially the same. Therefore, the inner peripheral surfaces of the partial simulated blood vessels 10 and 20 are flush with each other.

The partial simulated blood vessels 10 and 20 are formed of, for example, PVA gel obtained by gelling polyvinyl alcohol (hereinafter also referred to as "PVA"). Therefore, the partial simulated blood vessels 10 and 20 have good flexibility, similar to the actual blood vessels. More specifically, the central parts 17 and 27 of the partial simulated blood vessels 10 and 20 (that is, the parts excluding the first joint part 50) are mainly formed of physically crosslinked gel PG, which is made by gelling PVA by physical crosslinking. has been done. Here, in this specification, "gel" means that it is gel-like at room temperature or the temperature at which the vascular lesion model 100 is used (for example, 20° C. to 50° C.). PVA, which is the material for forming the partial simulated blood vessels 10 and 20, is a PVA homopolymer obtained by saponifying polyvinyl acetate, or a PVA homopolymer obtained by saponifying a copolymer of vinyl acetate and other monomers copolymerizable with it. Examples include the resulting PVA copolymer and a PVA modified product in which some of the hydroxyl groups contained in PVA are substituted with other substituents. Other monomers used in the PVA copolymer are not particularly limited, and include conventionally known monomers such as vinyl formate, vinyl propionate, vinyl benzoate, and vinyl t-butylbenzoate. Further, other substituents used in the PVA modified product are not particularly limited, and include, for example, a carboxyl group, a sulfonic acid group, an acetoacetyl group, an amine group, and the like. The above PVA is more preferably a PVA homopolymer. This is because it exhibits physical properties closer to actual blood vessels, such as shape stability and flexibility, and is safe to living organisms, making it easy to handle as a biological model. In addition, the said PVA can be used individually or in combination of 2 or more types.

In this embodiment, the average degree of polymerization of PVA is, for example, approximately 500 or more and 3000 or less. When the average degree of polymerization is less than 500, the gel obtained tends to be soft and difficult to maintain an independent shape as a biological model. On the other hand, if the average degree of polymerization exceeds 3000, the solubility of PVA in solvents (e.g., water) decreases, making it difficult to mold into a uniform gel shape. It tends to be difficult to do. The average degree of polymerization is more preferably about 1,000 or more and about 2,000 or less, and still more preferably about 1,500 or more and about 1,800 or less. Further, the degree of saponification of PVA is, for example, about 80 mol% or more. When the degree of saponification is less than 80 mol%, the strength of physical crosslinking tends to be weak, making it difficult to mold the PVA gel. The degree of saponification is more preferably 90 mol% or more, still more preferably 98 mol% or more.

The above-mentioned "physically cross-linked gel" refers to a gel that is cross-linked by non-covalent bonds such as hydrogen bonds and ionic bonds, and refers to a gel in which cross-linking points are reversibly created and eliminated by external forces such as temperature changes. There is. On the other hand, the "chemically crosslinked gel" described below is a gel that is crosslinked by covalent bonds, and means a gel whose crosslinking points do not disappear due to external forces such as temperature changes.

In the present embodiment, the first joint portion 50 is such that the first end portion 15 of the first partial simulated blood vessel 10 and the second end portion 25 of the second partial simulated blood vessel 20 are joined. This is the part I did. In this embodiment, more specifically, the first end surface S1 of the first partial simulated blood vessel 10 and the second end surface S2 of the second partial simulated blood vessel 20 are joined. Therefore, more specifically, the first joint portion 50 is a portion including the first end surface S1 and the second end surface S2. Further, in this embodiment, the first joint portion 50 is formed of chemically crosslinked gel CG (more specifically, mainly chemically crosslinked gel CG), which is made by gelling PVA by chemical crosslinking. In other words, the degree of chemical crosslinking of PVA in the first joint portion 50 is higher than the degree of chemical crosslinking of PVA in the portion other than the first joint portion 50. The higher the degree of chemical crosslinking in the PVA gel, the higher the hardness of the PVA gel. That is, the more chemical crosslinking in the PVA gel progresses, the higher the hardness of the PVA gel becomes. Therefore, the first joint portion 50 can simulate a blood vessel with high joint strength while maintaining properties similar to those of an actual blood vessel (relatively high elasticity and flexibility). Note that, as described above, the first joint portion 50 is mainly formed of chemically crosslinked gel CG of PVA, but may include physical crosslinked gel PG together with chemically crosslinked gel CG. In this embodiment, the degree of chemical crosslinking in the first joint portion 50 is approximately uniform.

Here, the "degree of chemical crosslinking" in the PVA gel can be expressed by conventionally known methods, such as the hardness of the PVA gel and the intensity of the spectrum shown by substituents formed by chemical crosslinking in the PVA gel. In the first joint portion 50, the hardness is approximately 30 gf/cm ² or more and 15000 gf/cm ² or less. When the hardness is less than 30 gf/cm ² , the gel obtained tends to be soft and difficult to maintain an independent shape as a biological model. On the other hand, if the hardness exceeds 15,000 gf/cm ² , the resulting gel becomes brittle, and tends to cause cracks in the gel or collapse due to external stress or stimulation. .

The hardness of the PVA gel can be determined by the storage modulus of the gel. The storage modulus of the gel can be measured, for example, using a dynamic viscoelasticity measuring device (“DMA7100” manufactured by Hitachi High-Technologies). That is, the hardness of the PVA gel of the first joint portion 50 can be obtained by measuring the storage modulus of the first joint portion 50. Specifically, it is as follows. The storage modulus is measured according to the following measurement procedure under the measurement conditions of temperature: 30° C., strain amplitude: 10 μm, and probe weight: 62.2671 g. For example, measurements were performed on a plurality of (for example, three) test samples, and the average value of the obtained values was taken as the storage modulus.
(1) Two PVA gels formed to a predetermined size (height: 10 mm, width: 10 mm, thickness: 1.6 mm) are prepared as test samples.
(2) Bring the above two test samples into contact with the measurement position of the shear test jig in a sandwiched manner.
(3) The shear test jig is installed in the main body of the test apparatus (DMA7100) and completely immersed in water at about 25°C.
(4) While starting measurement under the above measurement conditions, use a heater to heat the water around the test sample.
(5) Record the storage modulus when the water temperature and target sample temperature reach 30°C.

Further, the intensity of the spectrum shown by the substituents formed by chemical crosslinking in the PVA gel can be evaluated by a conventionally known method, for example, by the following method. When PVA is chemically crosslinked, for example by using glutaraldehyde as a chemical crosslinking agent, ester groups are formed in the PVA gel. Using nuclear magnetic resonance spectroscopy (NMR spectroscopy) or infrared spectroscopy (IR spectroscopy), identify the spectrum (chemical shift or peak) specific to this ester group, and calculate the intensity of the identified spectrum. .

As described above, the vascular lesion model 100 of this embodiment includes the simulated lesion part 130. The simulated lesion part 130 is a member that simulates an actual lesion part, and is located in a part of the hollow part 22 of the second partial simulated blood vessel 20. That is, the simulated lesion part 130 is located in a part of the vascular lesion model 100 (specifically, the simulated blood vessel 110) in the longitudinal direction. Furthermore, in the present embodiment, the simulated lesion part 130 is arranged at a predetermined position along the longitudinal direction of the second partial simulated blood vessel 20 so as to completely occlude the hollow part 22 .

As shown in FIG. 1, the simulated lesion 130 is a solid, substantially cylindrical body extending in the longitudinal direction of the simulated blood vessel 110 (specifically, the second partial simulated blood vessel 20). The diameter DL of the simulated lesion 130 is, for example, approximately 1 mm or more and 30 mm or less, and the length of the simulated lesion 130 is, for example, approximately 1 mm or more and 100 mm or less. That is, the diameter DL of the simulated lesion 130 in the direction substantially perpendicular to the longitudinal direction of the simulated blood vessel 110 (specifically, the second partial simulated blood vessel 20) and the portion where the simulated lesion 130 is located, The inner diameter DV of the simulated blood vessel 110 (specifically, the second partial simulated blood vessel 20) (in other words, the diameter of the hollow portion 22 of the second partial simulated blood vessel 20) is approximately the same. In this embodiment, the lesion is assumed to be a lesion caused by at least one of calcification, plaque formation, and fibrosis. Note that the diameter DL of the simulated lesion 130 is an example of the length of the simulated lesion in the claims.

The simulated lesion 130 is formed of, for example, a gel of a polymeric material having hydroxyl groups. Therefore, the simulated lesion 130 has good flexibility, similar to an actual blood vessel. More specifically, the simulated lesion 130 is formed of a physically crosslinked gel of the above polymer material, a chemically crosslinked gel, or a gel containing both of them. The polymeric material having hydroxyl groups is not particularly limited, and for example, PVA, which is the material for forming the simulated blood vessel 110, can be used. Other examples of the polymeric materials include hyaluronic acid, alginic acid, carboxymethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, nitrocellulose, cellulose acetate, agar, carrageenan, agarose, polysaccharides such as agaropectin, polyethylene glycol, polypropylene glycol, etc. Polyethers and their structural analogs, acrylic acid esters and their structural analogs such as polyhydroxyethyl acrylate, polyhydroxyethyl methacrylate (HEMA), polyacrylamide, polyN-isopropylacrylamide, polyacrylamide-2-methylpropanesulfone Examples include amides of acids, polyacrylic acid or polymethacrylic acid and their alkali metal salts, proteins, gelatin, polylactic acid, natural rubber, and copolymers thereof. The material for forming the simulated lesion 130 used in the vascular lesion model 100 of this embodiment is more preferably a PVA homopolymer. This is because it exhibits physical properties closer to actual blood vessels, such as shape stability and flexibility, and is safe to living organisms, making it easy to handle as a biological model. More preferably, it is a chemically crosslinked gel of PVA homopolymer from the viewpoint that it is the same forming material as the simulated blood vessel 110 (specifically, the second partial simulated blood vessel 20).

A-2. Manufacturing method of vascular lesion model 100:
Next, a method for manufacturing the vascular lesion model 100 in the first embodiment will be described. FIG. 3 is a flowchart showing a method for manufacturing the vascular lesion model 100 in this embodiment. Moreover, FIG. 4 is an explanatory diagram conceptually showing a method for manufacturing the vascular lesion model 100 in this embodiment.

First, a first partial simulated blood vessel 10 and a second partial simulated blood vessel 20 (simulated blood vessel 110) are prepared (S110, see FIG. 4(A)). More specifically, a first partial simulated blood vessel 10 and a second partial simulated having approximately the same outer diameter and the diameter of the hollow portion 22 as the outer diameter of the first partial simulated blood vessel 10 and the diameter of the hollow portion 12 are used. A blood vessel 20 is prepared. As described above, in this embodiment, the first partial simulated blood vessel 10 and the second partial simulated blood vessel 20 are formed of physically crosslinked gel PG. Physically crosslinked gel PG can be produced, for example, by a known method such as a cast dry method or a freeze-thaw method. The cast dry method is a method in which a PVA aqueous solution of a predetermined concentration is prepared by adding PVA to water and performing a heat treatment, and a physically crosslinked gel is obtained by drying this PVA aqueous solution. Furthermore, the freeze-thaw method is a method of obtaining a physically crosslinked gel by repeating freezing and thawing a predetermined number of times on a PVA aqueous solution similar to the above. When producing the physically cross-linked gel PG, the degree of physical cross-linking is increased by increasing the concentration of PVA constituting the physically cross-linked gel PG, and the simulated blood vessel 110 (the first partial simulated blood vessel 10 and the second partial simulated blood vessel 10) is The hardness and elasticity of the partial simulated blood vessel 20) can be increased. The simulated blood vessel 110 (the first partial simulated blood vessel 10 and the second partial simulated blood vessel 20) can be produced by molding physically crosslinked gel PG obtained by the above-mentioned known method into a tubular shape.

Next, the first end portion 15 of the first partial simulated blood vessel 10 is made to contain an acid catalyst AC (S120, see FIG. 4(B)). The acid catalyst AC is not particularly limited, and examples thereof include citric acid and hydrochloric acid. The concentration of the acid catalyst AC is, for example, about 0.01 mol/L or more and 1.0 mol/L or less, more preferably about 0.1 mol/L or more and 0.3 mol/L or less. The step S120 can be performed, for example, by immersing the first end portion 15 of the first partial simulated blood vessel 10 in a 0.5N citric acid aqueous solution at 25° C. under 1 ATM for 10 minutes.

Next, the second end portion 25 of the second partial simulated blood vessel 20 is made to contain the crosslinking agent CL (S130, see FIG. 4(B)). The crosslinking agent CL is not particularly limited, and examples thereof include dialdehydes such as glutaraldehyde, glyoxal, formalin, and terephthalaldehyde. Here, dialdehyde is an aldehyde having two aldehyde groups (formyl groups). The concentration of dialdehyde is, for example, about 0.01 mol/L or more and 1.0 mol/L or less, more preferably about 0.1 mol/L or more and 0.3 mol/L or less. The step S130 can be performed, for example, by immersing the second end portion 25 of the second partial simulated blood vessel 20 in a 25% aqueous solution of glutaraldehyde at 25° C. under 1 ATM for 10 minutes.

Next, the first end 15 of the first partial simulated blood vessel 10 and the second end 25 of the second partial simulated blood vessel 20 are joined to create a simulated blood vessel 110 (S140, FIG. (C), (D)). More specifically, the first end surface S1 of the first end 15 and the second end surface S2 of the second end 25 are brought into contact. The process of step S140 can be performed, for example, by bringing the first end surface S1 and the second end surface S2 into contact with each other and then leaving them at room temperature for 10 minutes (see FIG. 4(C)). By performing step S140, chemically crosslinked gel CG is formed from physically crosslinked gel PG at first end 15 and second end 25. As a result, a simulated blood vessel 110 in which the first end 15 and the second end 25 are joined can be produced (see FIG. 4(D)). In addition, in FIG. 4(C), citric acid as the acid catalyst AC is schematically indicated by "O", and dialdehyde as the crosslinking agent CL is schematically indicated by "△". Note that the degree of formation of the chemically crosslinked gel CG can be changed by adjusting the amount of the crosslinking agent CL and acid catalyst AC added, the pH of the acid catalyst AC, reaction pressure, reaction temperature, reaction time, etc. Alternatively, the chemical crosslink formation reaction may be stopped by immersing the first partial simulated blood vessel 10 and the second partial simulated blood vessel 20 in an alkaline solution such as sodium carbonate.

As shown in FIGS. 4(C) and (D), in S140, the first end 15 of the first partial simulated blood vessel 10 containing the acid catalyst AC and the second partial simulated blood vessel containing the crosslinking agent CL When the second end 25 of the blood vessel 20 is brought into contact with the second end 25 and left to stand at room temperature, between the first end 15 containing the acid catalyst AC and the second end 25 containing the crosslinking agent CL. A chemical crosslink is newly formed at the first end 15 and the second end 25 by the catalyst exchange reaction at, and as a result, a first joint portion 50 formed of the chemically crosslinked gel CG is formed. . This chemical crosslink formation reaction progresses in stages from the ends 15, 25 of the partial simulated blood vessels 10, 20 toward the central parts 17, 27. Therefore, in the newly formed first joint portion 50, the chemical crosslinking density is higher in the portions of the end portions 15, 25 closer to the end surfaces S1, S2, and the chemical crosslinking density is lower in the portions closer to the central portions 17, 27. Become. As mentioned above, the hardness of PVA gel increases as the degree of chemical crosslinking increases. Therefore, in the first joint portion 50, the portions closer to the end surfaces S1 and S2 have higher hardness, and the portions closer to the center portions 17 and 27 have lower hardness. As a result, the simulated blood vessel 110 has properties similar to a real blood vessel (relatively high elasticity and flexibility) without extreme hardness changes between the end portions 15, 25 and the central portions 17, 27. The partial simulated blood vessels 10 and 20 can be firmly joined to each other while maintaining the following properties.

Next, the simulated lesion 130 is inserted into the second partial simulated blood vessel 20 of the simulated blood vessel 110 (S150). Thereby, the vascular lesion model 100 can be produced.

A-3. Effects of the first embodiment:
As described above, the vascular lesion model 100 of the first embodiment includes the first partial simulated blood vessel 10 and the second partial simulated blood vessel 20, which are tubular and include PVA gel. The second partial simulated blood vessel 20 is joined to the first end 15 of the first partial simulated blood vessel 10. The first joint portion 50 between the first partial simulated blood vessel 10 and the second partial simulated blood vessel 20 contains chemically crosslinked gel CG. In the vascular lesion model 100 of this embodiment, the first joint portion 50 between the first partial simulated blood vessel 10 and the second partial simulated blood vessel 20 contains PVA gel. Therefore, the relatively high elasticity and flexibility of PVA gel can be maintained in the first joint portion 50 as well. Therefore, according to the vascular lesion model 100 of the present embodiment, the first partial simulated blood vessel 10 containing PVA gel has properties sufficiently similar to actual blood vessels (relatively high elasticity and flexibility). It is possible to provide a vascular lesion model 100 in which the second partial simulated blood vessel 20 is firmly connected.

Furthermore, in the vascular lesion model 100 of the present embodiment, the first joint portion 50 connects the first end 15 of the first partial simulated blood vessel 10 and the second end 25 of the second partial simulated blood vessel 20. This is the part where the two are joined. Therefore, the vascular lesion model 100 of the present embodiment provides the vascular lesion model 100 in which the first partial simulated blood vessel 10 and the second partial simulated blood vessel 20 are firmly connected without using other members. can do.

Further, the vascular lesion model 100 of the present embodiment includes a simulated lesion portion 130 located in the hollow portion 22 of the second partial simulated blood vessel 20 and in a part of the second partial simulated blood vessel 20 in the longitudinal direction. Therefore, according to the vascular lesion model 100 of the present embodiment, it is possible to provide a vascular lesion model that more closely resembles a living body having a lesion formed in a portion of an actual blood vessel in the longitudinal direction.

B. Second embodiment:
FIG. 5 is an explanatory diagram schematically showing the configuration of a vascular lesion model 100a in the second embodiment. FIG. 5 shows an XZ cross-sectional configuration of the vascular lesion model 100a of the second embodiment at the same position as in FIG. 2 (the position of section X1 in FIG. 1). Below, among the configurations of the vascular lesion model 100a of the second embodiment, descriptions of the same configurations as those of the vascular lesion model 100 of the first embodiment described above will be omitted as appropriate.

The vascular lesion model 100a of the second embodiment includes a simulated blood vessel 110a and a simulated lesion 130 (see FIG. 1). As shown in FIG. 5, the vascular lesion model 100a mainly has an inner circumferential surface SA1 of the first partial simulated blood vessel 10a and an outer circumferential surface SA2 of the second partial simulated blood vessel 20a at the first joint portion 50a. This differs from the vascular lesion model 100 of the first embodiment in that it is joined. The vascular lesion model 100a is an example of a biological model in the claims.

The simulated blood vessel 110a includes a first partial simulated blood vessel 10a and a second partial simulated blood vessel 20a. The first partial simulated blood vessel 10a is an example of a first member in the claims, and the second partial simulated blood vessel 20a is an example of a second member in the claims.

The first partial simulated blood vessel 10a has, in the longitudinal direction of the first partial simulated blood vessel 10a, a first end 15a that is one end, the other end (not shown), and a first central part 17a. have. In addition, the second partial simulated blood vessel 20a has a second end 25a that is one end, the other end (not shown), and a second central portion in the longitudinal direction of the second partial simulated blood vessel 20a. 27a. The first end 15a is a portion that overlaps with the second end 25a when viewed in a direction substantially perpendicular to the longitudinal direction of the simulated blood vessel 110a (for example, viewed in the Z-axis direction), and the second end 25a is This is a portion that overlaps with the first end portion 15a when viewed in the Z-axis direction. Here, the end portions 15a, 25a are, for example, approximately 2 mm or more and 10 cm or less when viewed in the Z-axis direction, similarly to the end portions 15, 25 of the first embodiment.

The first partial simulated blood vessel 10a and the second partial simulated blood vessel 20a each have a tubular shape (e.g. circular tube shape) having a hollow part (inner hole) 12a and a hollow part (inner hole) 22a, imitating an actual blood vessel. It is a member. The diameter of the hollow portion 12a in the first partial simulated blood vessel 10a is, for example, approximately 1 mm or more and 30 mm or less. Further, the diameter of the hollow portion 22a in the second partial simulated blood vessel 20a is smaller than the diameter of the hollow portion 12a in the first partial simulated blood vessel 10a, for example, approximately 1 mm or more and 30 mm or less. In this embodiment, the diameter of the hollow portion 12a of the first partial simulated blood vessel 10a is approximately the same as the outer diameter of the second partial simulated blood vessel 20a.

The material for forming the partial simulated blood vessels 10a and 20a is the same as the material for forming the partial simulated blood vessels 10 and 20 of the first embodiment.

In this embodiment, the vascular lesion model 100a includes a first joint portion 50a where a first partial simulated blood vessel 10a and a second partial simulated blood vessel 20a are joined. In this embodiment, more specifically, the inner circumferential surface SA1 at the first end 15a of the first partial simulated blood vessel 10a and the outer circumferential surface SA2 at the second end 25a of the second partial simulated blood vessel 20a. are joined. Therefore, more specifically, the first joint portion 50a is a portion including the inner circumferential surface SA1 at the first end 15a and the outer circumferential surface SA2 at the second end 25a. Further, the first joint portion 50a of this embodiment is formed by chemically crosslinked gel CG (more specifically, mainly by chemically crosslinked gel CG), similarly to the first joint portion 50 of the first embodiment. has been done. In other words, the degree of chemical crosslinking of PVA in the first joint portion 50a is higher than the degree of chemical crosslinking of PVA in the portions other than the first joint portion 50a. The first joint portion 50a is an example of a first joint portion in the claims.

The vascular lesion model 100a of this embodiment can be manufactured, for example, by the following method. First, by a method similar to the manufacturing method of the vascular lesion model 100 of the first embodiment, a first partial simulated blood vessel 10a is formed to have an outer diameter that is approximately the same as the diameter of the hollow portion 12a of the first partial simulated blood vessel 10a. A second partial simulated blood vessel 20a is prepared.

Next, the outer circumferential surface SA2 of the second end portion 25a of the second partial simulated blood vessel 20a is made to contain an acid catalyst AC. On the other hand, the crosslinking agent CL is contained in the inner circumferential surface SA1 of the first end portion 15a of the first partial simulated blood vessel 10a. Next, the second end 25a of the second partial simulated blood vessel 20a is inserted into the hollow portion 12a of the first partial simulated blood vessel 10a. That is, the inner peripheral surface SA1 of the first end 15a and the outer peripheral surface SA2 of the second end 25a are brought into contact. As a result, chemical crosslinks are newly formed on the inner circumferential surface SA1 of the first end 15a, the outer circumferential surface SA2 of the second end 25a, and in the vicinity thereof, and as a result, chemical crosslinks are formed by the chemically crosslinked gel CG. A first joint portion 50a is formed. In this way, a simulated blood vessel 110a is created. Finally, the vascular lesion model 100a can be created by inserting the simulated lesion 130 into the second partial simulated blood vessel 20a of the simulated blood vessel 110a.

According to the vascular lesion model 100a of the present embodiment, it is possible to provide the vascular lesion model 100a in which the first partial simulated blood vessel 10a and the second partial simulated blood vessel 20a are firmly connected without using other members. can. For example, the portion where the inner circumferential surface SA1 of the first end 15a of the first partial simulated blood vessel 10a and the outer circumferential surface SA2 of the second end 25e of the second partial simulated blood vessel 20a join may be enlarged (e.g. , the bonding area is increased), it is possible to more effectively increase the bonding strength between the first partial simulated blood vessel 10a and the second partial simulated blood vessel 20a.

C. Third embodiment:
FIG. 6 is an explanatory diagram schematically showing the configuration of a vascular lesion model 100b in the third embodiment. FIG. 6 shows an XZ cross-sectional configuration of the vascular lesion model 100b of the third embodiment at the same position as in FIG. 2 (the position of section X1 in FIG. 1). Below, among the configurations of the vascular lesion model 100b of the third embodiment, descriptions of the same configurations as those of the vascular lesion models 100 and 100a of the above-described embodiments will be omitted as appropriate.

The vascular lesion model 100b of the third embodiment includes a simulated blood vessel 110b and a simulated lesion 130 (see FIG. 1). As shown in FIG. 6, the vascular lesion model 100b differs from the vascular lesion model 100 of the first embodiment mainly in that the simulated blood vessel 110b further includes a sheet member 30b. The vascular lesion model 100b is an example of a biological model in the claims.

The simulated blood vessel 110b includes a first partial simulated blood vessel 10b, a second partial simulated blood vessel 20b, and a sheet member 30b. The first partial simulated blood vessel 10b is an example of the second member in the claims, the second partial simulated blood vessel 20b is an example of the third member in the claims, and the sheet member 30b is an example of the second member in the claims. , is an example of the first member in the claims.

The first partial simulated blood vessel 10b has, in the longitudinal direction of the first partial simulated blood vessel 10b, a first end 15b that is one end, the other end (not shown), and a first central part 17b. have. In addition, the second partial simulated blood vessel 20b has a second end 25b that is one end, the other end (not shown), and a second central part in the longitudinal direction of the second partial simulated blood vessel 20b. 27b. The first end portion 15a includes a first end surface S1, and is a portion that overlaps with the sheet member 30b when viewed in a direction substantially perpendicular to the longitudinal direction of the simulated blood vessel 110b (for example, viewed in the Z-axis direction). The second end portion 25a includes the second end surface S2 and is a portion that overlaps the sheet member 30b when viewed in the Z-axis direction. Here, the end portions 15b and 25b are, for example, approximately 2 mm or more and 5 cm or less when viewed in the Z-axis direction, similarly to the end portions 15 and 25 of the first embodiment. Further, in this embodiment, the first partial simulated blood vessel 10b and the second partial simulated blood vessel 20b are arranged such that the first end surface S1 and the second end surface S2 are in contact with each other. By arranging them in this manner, no gap is created between the first partial simulated blood vessel 10b and the second partial simulated blood vessel 20b. Therefore, for example, during PTA, it is possible to avoid the guide wire or the like from entering the gap and hindering training.

The first partial simulated blood vessel 10b and the second partial simulated blood vessel 20b each have a tubular shape (e.g. circular tube shape) having a hollow part (inner hole) 12b and a hollow part (inner hole) 22b, imitating an actual blood vessel. It is a member. The diameter of the hollow portions 12b, 22b in the partial simulated blood vessels 10b, 20b is, for example, approximately 1 mm or more and 30 mm or less. In this embodiment, the diameters of the hollow portions 12b and 22b of the partial simulated blood vessels 10b and 20b are substantially the same. Therefore, the inner peripheral surfaces of the partial simulated blood vessels 10b and 20b are flush with each other.

The material for forming the partial simulated blood vessels 10b and 20b is the same as the material for forming the partial simulated blood vessels 10 and 20 of the first embodiment.

The sheet member 30b is a sheet-like member disposed along the outer peripheral surfaces SB1, SB2 of the ends 15b, 25b of the partial simulated blood vessels 10b, 20b, and is made of the same material as that of the partial simulated blood vessels 10b, 20b. It is formed by That is, the sheet member 30b is made of, for example, PVA gel. Therefore, the sheet member 30b, together with the partial simulated blood vessels 10b and 20b, has good flexibility like the actual blood vessels. The sheet member 30b has a surface SB3 (hereinafter referred to as "joint surface SB3") facing the partial simulated blood vessels 10b and 20b. The bonding surface SB3 has a region that overlaps with the first end 15b of the first partial simulated blood vessel 10b (hereinafter referred to as a “first SB31") and a region overlapping with the second end 25b of the second partial simulated blood vessel 20b (hereinafter referred to as "second joining region SB32"). The thickness of the sheet member 30b is, for example, about 0.1 mm or more and 5 mm or less. If the thickness is less than 0.1 mm, the bonding strength between the first end 15b and the second end 25b tends to be insufficient. On the other hand, if the thickness exceeds 5 mm, the flexibility of the simulated blood vessel 110b tends to be insufficient. Further, when viewed in the Z-axis direction, the width of the sheet member 30b is, for example, approximately 4 mm or more and 10 cm or less, and is approximately the same as the total length of the end portions 15b and 25b.

In this embodiment, the vascular lesion model 100b includes a first joint portion 51b where the first partial simulated blood vessel 10b and the sheet member 30b are joined, and a second joint portion 51b where the second partial simulated blood vessel 20b and the sheet member 30b are joined. 2 joint portions 52b. In this embodiment, more specifically, the outer circumferential surface SB1 at the first end 15b of the first partial simulated blood vessel 10b and the first joint region SB31 at the joint surface SB3 of the sheet member 30b are joined. There is. Further, the outer circumferential surface SB2 at the second end 25b of the second partial simulated blood vessel 20b and the second joining region SB32 at the joining surface SB3 of the sheet member 30b are joined. Therefore, more specifically, the first joint portion 51b is a portion including the outer circumferential surface SB1 at the first end portion 15b and the first joint region SB31 of the sheet member 30b. Further, the second joint portion 52b is a portion including the outer circumferential surface SB2 at the second end portion 25b and the second joint region SB32 of the sheet member 30b. Further, the joint parts 51b and 52b of this embodiment are formed of chemically crosslinked gel CG (more specifically, mainly of chemically crosslinked gel CG), similarly to the first joint part 50 of the first embodiment. ing. In other words, the degree of chemical crosslinking of PVA in the joint portions 51b, 52b is higher than the degree of chemical crosslinking of PVA in the portions other than the joint portions 51b, 52b. The outer circumferential surface SB1 is an example of the first outer circumferential surface in the claims, and the outer circumferential surface SB2 is an example of the second outer circumferential surface in the claims. The first joint portion 51b is an example of the first joint portion in the claims, and the second joint portion 52b is an example of the second joint portion in the claims.

The vascular lesion model 100b of this embodiment can be manufactured, for example, by the following method. First, by a method similar to the manufacturing method of the vascular lesion model 100 of the first embodiment, a first partial simulated blood vessel 10b and an outer diameter that is approximately the same as the outer diameter of the first partial simulated blood vessel 10b and the diameter of the hollow portion 12b are manufactured. A second partial simulated blood vessel 20b having the diameter and the diameter of the hollow portion 22b is prepared.

Next, the sheet member 30b is prepared. More specifically, the sheet member 30b is produced by, for example, forming physically crosslinked gel PG obtained by the above-mentioned cast dry method or freeze-thaw method into a sheet shape.

Next, an acid catalyst AC is contained in the outer peripheral surface SB1 of the first end 15b of the first partial simulated blood vessel 10b and the outer peripheral surface SB2 of the second end 25b of the second partial simulated blood vessel 20b. . On the other hand, the sheet member 30b is made to contain a crosslinking agent CL. Next, the first end surface S1 of the first end portion 15b and the second end surface S2 of the second end portion 25b are brought into contact with each other, and the sheet member 30b is wound so as to overlap the end portions 15b and 25b. , leave it still. That is, the outer circumferential surface SB1 at the first end 15b and the outer circumferential surface SB2 at the second end 25b are brought into contact with the joining surface SB3 of the sheet member 30b. As a result, chemical crosslinks are newly formed in the outer circumferential surface SB1 of the first end 15b, the first bonding area SB31 on the bonding surface SB3 of the sheet member 30b, and in the vicinity thereof, and as a result, chemically crosslinked gel CG A first joint portion 51b is formed. Further, chemical crosslinks are newly formed in the outer circumferential surface SB2 of the second end portion 25b, the second bonding area SB32 on the bonding surface SB3 of the sheet member 30b, and in the vicinity thereof, and as a result, chemical crosslinks are formed by the chemically crosslinked gel CG. A second joint portion 52b is formed. In this way, a simulated blood vessel 110b is created. Finally, the vascular lesion model 100b can be created by inserting the simulated lesion 130 into the second partial simulated blood vessel 20b of the simulated blood vessel 110b.

According to the vascular lesion model 100b of this embodiment, the vascular lesion model 100b is provided in which the first partial simulated blood vessel 10b and the second partial simulated blood vessel 20b are firmly connected via the sheet-like sheet member 30b. be able to. For example, by increasing the bonding surface SB3 of the sheet member 30b, the bonding strength between the sheet member 30b and the partial simulated blood vessels 10b and 20b can be increased, and as a result, the first partial simulated blood vessel 10b and the second partial simulated blood vessel The strength of the connection with the blood vessel 20b can be more effectively increased.

D. Variant:
D-1. First variant:
FIG. 7 is an explanatory diagram schematically showing the configuration of a vascular lesion model 100c in the first modification. FIG. 7 shows an XZ cross-sectional configuration of the vascular lesion model 100c of the first modification at the same position as in FIG. 2 (the position of the X1 section in FIG. 1). Below, among the configurations of the vascular lesion model 100c of the first modification, descriptions of the same configurations as the vascular lesion models 100, 100a, and 100b of the embodiments described above will be omitted as appropriate.

The vascular lesion model 100c of the first modification includes a simulated blood vessel 110c and a simulated lesion 130 (see FIG. 1). As shown in FIG. 7, the vascular lesion model 100c differs from the vascular lesion model 100 of the first embodiment mainly in that the simulated blood vessel 110c further includes a connecting member 40c. The vascular lesion model 100c is an example of a biological model in the claims.

The simulated blood vessel 110c includes a first partial simulated blood vessel 10c, a second partial simulated blood vessel 20c, and a connecting member 40c. The first partial simulated blood vessel 10c and the second partial simulated blood vessel 20c are each an example of a first member in the claims, and the connecting member 40c is an example of the second member in the claims. be.

The first partial simulated blood vessel 10c has, in the longitudinal direction of the first partial simulated blood vessel 10c, a first end 15c, which is one end, the other end (not shown), and a first central part 17c. have. In addition, the second partial simulated blood vessel 20c has a second end 25c as one end, the other end (not shown), and a second central part in the longitudinal direction of the second partial simulated blood vessel 20c. 27c. The first end 15c is a portion including the first end surface S1, and the second end 25c is a portion including the second end surface S2. Here, the end portions 15c and 25c are, for example, approximately 2 mm or more and 5 cm or less when viewed in the Z-axis direction, similarly to the end portions 15 and 25 of the first embodiment.

The connecting member 40c is a tubular (e.g., circular) member having a hollow portion (inner hole) 42c, imitating an actual blood vessel, and connects the first end 15c of the first partial simulated blood vessel 10c and the second and the second end 25c of the partial simulated blood vessel 20c. The connecting member 40c has a third end 45c as one end, a fourth end 46c as the other end, and a first central portion 47c in the longitudinal direction of the connecting member 40c. There is. The diameter of the hollow portion 42c in the connecting member 40c is, for example, about 1 mm or more and 30 mm or less, and is approximately the same as the diameter of the hollow portions 12c and 22c of the partial simulated blood vessels 10c and 20c. Therefore, the inner peripheral surfaces of the partial simulated blood vessels 10c and 20c and the inner peripheral surface of the connecting member 40c are flush with each other. Further, in the longitudinal direction of the simulated blood vessel 110c, the length of the connecting member 40c is, for example, approximately 2 mm or more and 5 cm or less. The connecting member 40c is made of the same material as that of the partial simulated blood vessels 10c and 20c. That is, the connecting member 40c is formed, for example, of physically crosslinked gel PG (more specifically, mainly of physically crosslinked gel PG). Therefore, the connecting member 40c, together with the partial simulated blood vessels 10c and 20c, has good flexibility like the actual blood vessels.

In this modification, the vascular lesion model 100c includes a first joint portion 51c where the first partial simulated blood vessel 10c and the connecting member 40c are joined, and a first joint portion 51c where the second partial simulated blood vessel 20c and the connecting member 40c are joined. 2 joint portions 52c. In other words, in this modification, the first joint portion 51c connects the first end 15c of the first partial simulated blood vessel 10c and the third end 45c, which is one end of the connecting member 40c. is the joined part. Further, the second joint portion 52c is a portion where the second end portion 25c of the second partial simulated blood vessel 20c and the fourth end portion 46c, which is the other end portion of the connecting member 40c, are joined. In this modification, more specifically, the first end surface S1 of the first partial simulated blood vessel 10c and the third end surface SC1 of the connecting member 40c are joined. Further, the second end surface S2 of the second partial simulated blood vessel 20c and the fourth end surface SC2 of the connecting member 40c are joined. Therefore, more specifically, the first joint portion 51c is a portion that includes the first end surface S1 and the third end surface SC1, and the second joint portion 52c is a portion that includes the second end surface S2 and the third end surface SC1. This is the portion including the end surface SC2 of No. 4. Further, the joint parts 51c and 52c of this modification are formed of chemically crosslinked gel CG (more specifically, mainly of chemically crosslinked gel CG), similarly to the first joint part 50 of the first embodiment. ing. In other words, the degree of chemical crosslinking of PVA in the joint portions 51c and 52c is higher than the degree of chemical crosslinking of PVA in the portions of the partial simulated blood vessels 10c and 20c excluding the joint portions 51c and 52c. The first joint portion 51c and the second joint portion 52c are each an example of a first joint portion in the claims.

The vascular lesion model 100c of this modification can be manufactured, for example, by the following method. First, by a method similar to the manufacturing method of the vascular lesion model 100 of the first embodiment, a first partial simulated blood vessel 10c is made with an outer diameter that is approximately the same as the outer diameter of the first partial simulated blood vessel 10c and the diameter of the hollow portion 12c. A second partial simulated blood vessel 20c having the diameter and the diameter of the hollow portion 22c is prepared.

Next, the connecting member 40c is prepared. More specifically, the connecting member 40c is formed to have an outer diameter and a hollow space that are approximately the same as the outer diameters of the partial simulated blood vessels 10c and 20c and the diameters of the hollow portions 12c and 22c, for example, by the same method as the partial simulated blood vessels 10c and 20c. A connecting member 40c having a diameter of section 42c is manufactured.

Next, the first end 15c of the first partial simulated blood vessel 10c and the second end 25c of the second partial simulated blood vessel 20c contain acid catalyst AC. On the other hand, the connecting member 40c is made to contain the crosslinking agent CL. Next, the first end surface S1 of the first end 15c and the third end surface SC1 of the third end 45c are brought into contact. Further, the second end surface S2 of the second end portion 25c and the fourth end surface SC2 of the fourth end portion 46c are brought into contact with each other. As a result, chemical crosslinks are newly formed on the first end surface S1 of the first end 15c, the third end surface SC1 of the third end 45c, and in the vicinity thereof, and as a result, the chemically crosslinked gel CG A first joint portion 51c is formed. In addition, chemical crosslinks are newly formed on the second end surface S2 of the second end 25c, the fourth end surface SC2 of the fourth end 46c, and in the vicinity thereof, and as a result, chemical crosslinks are formed by the chemically crosslinked gel CG. A second joint portion 52c is formed. In this way, a simulated blood vessel 110c is created. Finally, the vascular lesion model 100c can be created by inserting the simulated lesion 130 into the second partial simulated blood vessel 20c of the simulated blood vessel 110c.

D-2. Second variant:
FIG. 8 is an explanatory diagram schematically showing the configuration of a vascular lesion model 100d in the second modification. FIG. 8 shows an XZ cross-sectional configuration of a vascular lesion model 100d of a second modification at the same position as in FIG. 2 (the position of section X1 in FIG. 1). In the following, descriptions of the same configurations as the vascular lesion models 100, 100a, 100b, and 100c of the embodiment and the modified examples described above in the vascular lesion model 100d of the second modification will be omitted as appropriate.

The vascular lesion model 100d of the second modification includes a simulated blood vessel 110d and a simulated lesion 130 (see FIG. 1). As shown in FIG. 8, the vascular lesion model 100d differs from the vascular lesion model 100d of the first embodiment mainly in that the simulated blood vessel 110d further includes a sheet member 30d and a connecting member 40d. The vascular lesion model 100d is an example of a biological model in the claims.

The simulated blood vessel 110d includes a first partial simulated blood vessel 10d, a second partial simulated blood vessel 20d, a sheet member 30d, and a connecting member 40d. The first partial simulated blood vessel 10d is an example of the second member in the claims, and the second partial simulated blood vessel 20d is an example of the third member in the claims. The sheet member 30d is an example of the first member in the claims, and the connecting member 40d is an example of the fourth member in the claims.

The first partial simulated blood vessel 10d has, in the longitudinal direction of the first partial simulated blood vessel 10d, a first end 15d that is one end, the other end (not shown), and a first central part 17d. have. In addition, the second partial simulated blood vessel 20d has a second end 25d that is one end, the other end (not shown), and a second central part in the longitudinal direction of the second partial simulated blood vessel 20d. 27d. The first end portion 15d includes the first end surface S1 and is a portion that overlaps with the sheet member 30d when viewed in a direction (for example, viewed in the Z-axis direction) substantially orthogonal to the longitudinal direction of the simulated blood vessel 110d. The second end portion 25d includes the second end surface S2 and is a portion that overlaps with the sheet member 30d when viewed in the Z-axis direction. Here, the end portions 15d and 25d are, for example, approximately 2 mm or more and 5 cm or less when viewed in the Z-axis direction, similarly to the end portions 15 and 25 of the first embodiment.

Similar to the connecting member 40c of the first modification, the connecting member 40d is a tubular (e.g., circular) member having a hollow portion (inner hole) 42d that imitates an actual blood vessel, and is a first partial simulated blood vessel. 10d and a second end 25d of the second partial simulated blood vessel 20d. The diameter of the hollow portion 42d in the connecting member 40d, the length of the connecting member 40d, and the material for forming the connecting member 40d are the same as those of the connecting member 40c described above.

The sheet member 30d is a sheet-like member disposed along the outer circumferential surface SD4 of the connecting member 40d and the outer circumferential surfaces SD1, SD2 of the ends 15d, 25d of the partial simulated blood vessels 10d, 20d. The thickness and width of the sheet member 30d and the material from which the sheet member 30d is formed are the same as those of the sheet member 30b described above. In addition, in this modification, the width of the sheet member 30d is approximately the same as the total length of the end portions 15d, 25d and the connecting member 40d when viewed in the Z-axis direction. The sheet member 30d has a connecting member 40d and a surface SD3 (hereinafter referred to as "joining surface SD3") facing the partial simulated blood vessels 10d and 20d. The joining surface SD3 is a first joining surface that is a region that overlaps with the first end 15d of the first partial simulated blood vessel 10d when viewed in a direction substantially orthogonal to the longitudinal direction of the simulated blood vessel 110d (for example, viewed in the Z-axis direction). It has a region SD31, a second joint region SD32 that is a region that overlaps with the second end 25d of the second partial simulated blood vessel 20d, and a third joint region SD33 that is a region that overlaps with the connecting member 40d. There is.

Furthermore, in this modification, the first partial simulated blood vessel 10d and the connecting member 40d are arranged such that the first end surface S1 (end portion 16d) and the third end surface SC1 are in contact with each other. Further, the second partial simulated blood vessel 20d and the connecting member 40d are arranged such that the second end surface S2 (end portion 26d) and the fourth end surface SC2 are in contact with each other.

In this modification, the vascular lesion model 100d includes a first joint portion 51d where the first partial simulated blood vessel 10d and the sheet member 30d are joined, and a second joint portion 51d where the second partial simulated blood vessel 20d and the sheet member 30d are joined. 2 joint portions 52d. The vascular lesion model 100d also includes a third joint portion 53d where the first partial simulated blood vessel 10d and the connecting member 40d are joined, and a fourth joint portion where the second partial simulated blood vessel 20d and the connecting member 40d are joined. It includes a portion 54d. In this modification, more specifically, the first joint portion 51d is a portion including the outer circumferential surface SD1 at the first end portion 15d and the first joint region SD31 of the sheet member 30d. Further, the second joint portion 52d is a portion including the outer circumferential surface SD2 at the second end portion 25d and the second joint region SD32 of the sheet member 30d. Further, the third joint portion 53d is a portion that includes the first end surface S1 and the third end surface SC1, and the fourth joint portion 54d includes the second end surface S2 and the fourth end surface SC2. It is a part. In addition, the joint parts 51d, 52d, 53d, and 54d of this modification are made of chemically crosslinked gel CG (more specifically, mainly chemically crosslinked gel CG), similarly to the first joint part 50 of the first embodiment. formed by). In other words, the degree of chemical crosslinking of PVA in the joint parts 51d, 52d, 53d, 54d is higher than the degree of chemical crosslinking of PVA in the parts of the partial simulated blood vessels 10d, 20d excluding the joint parts 51d, 52d, 53d, 54d. expensive. The first joint portion 51d is an example of the first joint portion in the claims, and the second joint portion 52d is an example of the second joint portion in the claims.

The vascular lesion model 100d of this modification can be manufactured, for example, by the following method. First, by a method similar to the manufacturing method of the vascular lesion model 100 of the first embodiment, a first partial simulated blood vessel 10d is formed with an outer diameter that is approximately the same as the outer diameter of the first partial simulated blood vessel 10d and the diameter of the hollow portion 12d. A second partial simulated blood vessel 20d having the diameter and the diameter of the hollow portion 22d is prepared.

Next, the connecting member 40d is prepared. More specifically, the connecting member 40d is formed with an outer diameter and hollow space approximately the same as the outer diameter of the partial simulated blood vessels 10d and 20d and the diameter of the hollow portions 12d and 22d, for example, by the same method as the partial simulated blood vessels 10d and 20d. A connecting member 40d having a diameter of the portion 42d is manufactured.

Next, the sheet member 30d is prepared. More specifically, the sheet member 30d is produced by, for example, forming physically crosslinked gel PG obtained by the above-mentioned cast dry method or freeze-thaw method into a sheet shape.

Next, the outer circumferential surface SD1 and the end 16d of the first end 15d of the first partial simulated blood vessel 10d, and the outer circumferential surface SD2 and the end 26d of the second end 25d of the second partial simulated blood vessel 20d. , contains an acid catalyst AC. On the other hand, the sheet member 30d and the connecting member 40d contain the crosslinking agent CL. Next, the first end surface S1 of the first end portion 15d and the third end surface SC1 of the connecting member 40d are brought into contact. Further, the second end surface S2 of the second end portion 25d and the fourth end surface SC2 of the connecting member 40d are brought into contact. Furthermore, after winding the sheet member 30d so as to overlap the connecting member 40d and the end portions 15d and 25d, the sheet member 30d is left still. As a result, joint portions 51d, 52d, 53d, and 54d made of chemically crosslinked gel CG are formed. In this way, a simulated blood vessel 110d is created. Finally, the vascular lesion model 100d can be created by inserting the simulated lesion 130 into the second partial simulated blood vessel 20d of the simulated blood vessel 110d.

According to the vascular lesion model 100d of this modification, the first partial simulated blood vessel 10d and the second partial simulated blood vessel 20d, which are connected via the sheet-like sheet member 30d, are made of chemically cross-linked gel CG. By using the connecting member 40d, it is possible to provide the vascular lesion model 100d that is more firmly connected. Furthermore, the first end 15d of the first partial simulated blood vessel 10d that joins the connecting member 40d and the second end 25d of the second partial simulated blood vessel 20d that joins the connecting member 40d are chemically crosslinked. Contains gel CG. Therefore, the bonding strength between the connecting member 40d and the partial simulated blood vessels 10d and 20d can be increased, and in turn, the bonding strength between the first partial simulated blood vessel 10d and the second partial simulated blood vessel 20d can be increased more effectively. be able to.

D-3. Third variation:
FIG. 9 is an explanatory diagram schematically showing the configuration of a vascular lesion model 100e in a third modification. FIG. 9 shows an XZ cross-sectional configuration of the vascular lesion model 100e of the third modification at the same position as in FIG. 2 (the position of section X1 in FIG. 1). In the following, descriptions of the same configurations as the vascular lesion models 100, 100a, 100b, 100c, and 100d of the embodiment and the modified example described above in the vascular lesion model 100e of the third modification will be omitted as appropriate.

The vascular lesion model 100e of the third modification includes a simulated blood vessel 110e and a simulated lesion 130 (see FIG. 1). As shown in FIG. 9, the vascular lesion model 100e differs from the vascular lesion model 100b of the third embodiment mainly in that the simulated blood vessel 110e further includes a filling member 60e. The vascular lesion model 100e is an example of a biological model in the claims.

The simulated blood vessel 110e includes a first partial simulated blood vessel 10e, a second partial simulated blood vessel 20e, a sheet member 30e, and a filling member 60e. The sheet member 30e is an example of a first member in the claims, and the filling member 60e is an example of a second member in the claims.

The first partial simulated blood vessel 10e has, in the longitudinal direction of the first partial simulated blood vessel 10e, a first end 15e that is one end, the other end (not shown), and a first central part 17e. have. In addition, the second partial simulated blood vessel 20e has a second end 25e that is one end, the other end (not shown), and a second central part in the longitudinal direction of the second partial simulated blood vessel 20e. 27e. The first end portion 15e includes the first end surface S1 and is a portion that overlaps with the sheet member 30e when viewed in a direction (for example, viewed in the Z-axis direction) substantially orthogonal to the longitudinal direction of the simulated blood vessel 110e. The second end portion 25e includes the second end surface S2 and is a portion that overlaps with the sheet member 30e when viewed in the Z-axis direction. Here, the end portions 15e and 25e are, for example, approximately 2 mm or more and 5 cm or less when viewed in the Z-axis direction, similarly to the end portions 15b and 25b of the third embodiment. Furthermore, in this modification, the first partial simulated blood vessel 10e and the second partial simulated blood vessel 20e are arranged such that the first end surface S1 and the second end surface S2 are spaced apart. That is, a separation portion 63e is formed between the first end surface S1 and the second end surface S2. The length of the separating portion 63e is, for example, about 0.1 mm or more and 1 cm or less when viewed in the Z-axis direction.

The filling member 60e is arranged between the first partial simulated blood vessel 10e and the second partial simulated blood vessel 20e, that is, in the spaced apart portion 63e. In other words, when viewed in the Z-axis direction, the length of the filling member 60e in the separation portion 63e is the same as the length of the separation portion 63e, for example, approximately 0.1 mm or more and 1 cm or less in the Z-axis direction. . In this modification, the filling member 60e is also arranged on the inner peripheral surface SE4 of the first partial simulated blood vessel 10e and the inner peripheral surface SE5 of the second partial simulated blood vessel 20e. When viewed in the Z-axis direction, the length of the filling member 60e at the inner circumferential surfaces SE4, SE5 of the partial simulated blood vessels 10e, 20e is longer than the length of the filling member 60e at the separation part 63e, for example, when viewed in the Z-axis direction, the length of the filling member 60e is 0. It is about 5 mm or more and 3 cm or less. Therefore, in addition to the ends 15e and 25e of the partial simulated blood vessels 10e and 20e, the inner circumferential surfaces SE4 and SE5 can also be joined via the filling member 60e. can be increased. The filling member 60e is made of the same material as that of the partial simulated blood vessels 10e and 20e. That is, the filling member 60e is formed, for example, of chemically crosslinked gel CG (more specifically, mainly of chemically crosslinked gel CG). Therefore, the filling member 60e, together with the partial simulated blood vessels 10e and 20e, has good flexibility like the actual blood vessels. In addition, by disposing the filling member 60e in the separation part 63e, it is possible to prevent a guide wire or the like from entering the separation part 63e during PTA, for example, and hindering training.

The sheet member 30e is a sheet-like member disposed along the outer circumferential surface SE6 of the filling member 60e and the outer circumferential surfaces SE1, SE2 of the end portions 15e, 25e of the partial simulated blood vessels 10e, 20e. The thickness and width of the sheet member 30e, and the material from which the sheet member 30e is formed are the same as those of the sheet member 30b described above. Note that in this modification, the width of the sheet member 30e in the Z-axis direction is approximately the same as the total length of the end portions 15e, 25e and the filling member 60e. The sheet member 30e has a filling member 60e and a surface SE3 (hereinafter referred to as "joint surface SE3") facing the partial simulated blood vessels 10e and 20e. The joining surface SE3 is a first joining surface that is a region that overlaps with the first end 15e of the first partial simulated blood vessel 10e when viewed in a direction substantially orthogonal to the longitudinal direction of the simulated blood vessel 110e (for example, viewed in the Z-axis direction). The region SE31, the second joining region SE32, which is a region that overlaps with the second end 25e of the second partial simulated blood vessel 20e, and the region that overlaps with the separation part 63e (that is, the region that joins with the filling member 60e) It has a third bonding region SE33.

In this modification, the vascular lesion model 100e includes a first joint portion 50e where the filling member 60e and the sheet member 30e are joined. In this modification, more specifically, the first joint portion 50e is a portion including the filling member 60e, and the third joint region SE33 in the sheet member 30e and the first joint region SE33 in the first partial simulated blood vessel 10e. , and a second end surface S2 of the second partial simulated blood vessel 20e. Further, the first joint portion 50e of this modification is made of PVA gel, similar to the joint portions 51b and 52b of the third embodiment. More specifically, the first joint portion 50e is mainly formed of chemically crosslinked gel CG. The first joint portion 50e is an example of a first joint portion in the claims.

The vascular lesion model 100e of this modification can be manufactured, for example, by the following method. First, by a method similar to the manufacturing method of the vascular lesion model 100b of the third embodiment, a first partial simulated blood vessel 10e is formed with an outer diameter that is approximately the same as the outer diameter of the first partial simulated blood vessel 10e and the diameter of the hollow portion 12e. A second partial simulated blood vessel 20e having the diameter and the diameter of the hollow portion 22e is prepared.

Next, the sheet member 30e is prepared. More specifically, the sheet member 30e is produced by, for example, forming physically crosslinked gel PG obtained by the above-mentioned cast dry method or freeze-thaw method into a sheet shape, and adding a crosslinking agent CL to the sheet.

Next, a precursor of the filling member 60e is prepared. More specifically, the precursor of the filling member 60e is produced by, for example, adding an acid catalyst AC to a PVA solution.

Next, a precursor of the filling member 60e is filled between the first end surface S1 of the first end portion 15e and the second end surface S2 of the second end portion 25e (separated portion 63e). Furthermore, after wrapping the sheet member 30e so as to overlap the filling member 60e and the end portions 15e and 25e, the sheet member 30e is left standing. As a result, a first joint portion 50e made of chemically crosslinked gel CG is formed. In this way, a simulated blood vessel 110e is created. Finally, by inserting the simulated lesion 130 into the second partial simulated blood vessel 20e of the simulated blood vessel 110e, a vascular lesion model 100e can be created.

In this modification, the sheet member 30e containing the crosslinking agent CL not only joins with the filling member 60e containing the acid catalyst AC, but also joins the outer periphery of the partial simulated blood vessels 10e, 20e at the ends 15e, 25e. It is also joined to surfaces SE1 and SE2. The filling member 60e also joins to the end surfaces S1, S2 of the partial simulated blood vessels 10e, 20e and the inner peripheral surfaces SE4, SE5 at the ends 15e, 25e of the partial simulated blood vessels 10e, 20e, respectively. This is because the crosslinking agent CL contained in the sheet member 30e and the acid catalyst AC contained in the filling member 60e are at the ends 15e of the partial simulated blood vessels 10e and 20e, which are in contact with the sheet member 30e and the filling member 60e, respectively. , 25e, a catalyst exchange reaction occurs also at the ends 15e and 25e, and a chemical crosslink is newly formed.

D-4. Other variations:
The technology disclosed in this specification is not limited to the above-described embodiments and modified examples, and can be modified into various forms without departing from the gist thereof. For example, the following modifications are also possible. be.

In the first embodiment, the first partial simulated blood vessel 10 and the second partial simulated blood vessel 20 are made of substantially the same material and the diameters of the hollow parts 12 and 22 are substantially the same, but the present invention is not limited to this. First, a configuration in which these are different from each other may be adopted. Further, in this embodiment, the partial simulated blood vessels 10 and 20 are formed of PVA gel, but the present invention is not limited to this, and a structure containing resin other than PVA may be adopted.

In the first embodiment, the degree of chemical crosslinking in the first joint portion 50 is substantially uniform, but the present invention is not limited to this, and the degree of chemical crosslinking is different (for example, the degree of chemical crosslinking is (with a gradient) may also be adopted.

In the third embodiment, the sheet member 30b may be disposed along the outer circumferential surfaces SB1, SB2 of the ends 15b, 25b of the partial simulated blood vessels 10b, 20b. That is, the sheet member 30b may be arranged over the entire circumference of the outer peripheral surfaces SB1 and SB2, or may be arranged only on a part of the entire circumference (for example, half the circumference). From the viewpoint of more firmly joining the partial simulated blood vessels 10b and 20b, it is preferable that the sheet member 30b is disposed around the entire circumference of the outer circumferential surfaces SB1 and SB2.

In the first embodiment, a configuration is adopted in which the simulated lesion part 130 is provided in the hollow part 22 of the simulated blood vessel 110 (second partial simulated blood vessel 20), but the present invention is not limited to this. A configuration without this may also be adopted. That is, a blood vessel model may be used instead of the blood vessel lesion model 100 of the first embodiment. Further, in the first embodiment, the simulated lesion part 130 is formed to completely occlude the hollow part 22 of the simulated blood vessel 110 (second partial simulated blood vessel 20), but the simulated lesion part 130 is 110 (second partial simulated blood vessel 20) so as not to completely occlude the hollow part 22 (that is, a second may be formed so as to ensure a flow path passing through the partial simulated blood vessel 20 in the axial direction. Moreover, the simulated lesion part 130 is not limited to a solid substantially cylindrical body, but may have other shapes such as a cylindrical body.

10, 10a, 10b, 10c, 10d, 10e: First partial simulated blood vessel 12, 12a, 12b, 12c, 12d, 12e: Hollow part 22, 22a, 22b, 22c, 22d, 22e: Hollow part 15, 15a, 15b, 15c, 15d, 15e: First end portion 16d: End portion 17, 17a, 17b, 17c, 17d, 17e: First central portion 20, 20a, 20b, 20c, 20d, 20e: Second portion Simulated blood vessel 25, 25a, 25b, 25c, 25d, 25e: second end 26d: end 27, 27a, 27b, 27c, 27d, 27e: second central part 30b, 30d, 30e: sheet member 40c, 40d: Connecting member 42c: Hollow part 42d: Hollow part 45c: Third end 46c: Fourth end 47c: First central part 50, 50a, 50e: First joint part 51b, 51c, 51d: First joint portion 52b, 52c, 52d: Second joint portion 53d: Third joint portion 54d: Fourth joint portion 60e: Filling member 63e: Separation portion 100, 100a, 100b, 100c, 100d, 100e: Vascular lesion model 110, 110a, 110b, 110c, 110d, 110e: Simulated blood vessel 130: Simulated lesion area

Claims (7)

A biological model,
a first member containing polyvinyl alcohol gel;
a second member joined to at least a portion of the first member, the second member containing polyvinyl alcohol gel,
The first member and the second member are formed of a gel physically crosslinked with polyvinyl alcohol,
a first joint between the first member and the second member includes a chemically crosslinked gel;
biological model. The biological model according to claim 1,
The first member and the second member are each tubular,
The first joint portion is a portion where one end in the longitudinal direction of the first member and one end in the longitudinal direction of the second member are joined.
biological model. The biological model according to claim 1,
The first member and the second member are each tubular,
The first joint portion is a portion where an inner peripheral surface of the first member on one end side in the longitudinal direction and an outer peripheral surface of the second member on one end side in the longitudinal direction are joined. is,
biological model. The biological model according to claim 1,
comprising a polyvinyl alcohol gel and a tubular third member;
The first member has a sheet shape,
the second member is tubular;
A first outer circumferential surface on one end side in the longitudinal direction of the second member and a second outer circumferential surface on one end side in the longitudinal direction of the third member are respectively It is joined to the joining surface which is one surface of the member,
The first joint portion is a portion where the joint surface of the first member and the first outer circumferential surface of the second member are joined,
a second joint portion between the joint surface of the first member and the second outer circumferential surface of the third member includes a chemically crosslinked gel;
biological model. The biological model according to claim 4,
A fourth member made of chemically crosslinked gel is provided between the second member and the third member,
One end of the fourth member is joined to the one end of the second member, and the other end of the fourth member is connected to the one end of the third member. It is joined to the end,
The one end of the second member and the one end of the third member each contain a chemically crosslinked gel.
biological model. In the biological model according to any one of claims 1 to 5,
the first member and the second member are simulated blood vessels;
biological model. The biological model according to claim 6,
a hollow part of the simulated blood vessel and a simulated lesion located in a part in the longitudinal direction of the simulated blood vessel;
biological model.

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