Vascular Lesion Model

Abstract

This vascular lesion model comprises a tubular blood vessel model and a lesion model arranged in a lumen of the blood vessel model. The lesion model has a plurality of lesion sites which are arranged along the length direction of the blood vessel model and include first lesion sites formed from a first polymeric material and second lesion sites formed from a second polymeric material, in which at least one end part in the length direction is fixed to an inner peripheral surface of the blood vessel model to restrict the movement of the lesion model along the length direction.

Description

[Technical field]

[0001] The present invention relates to a vascular lesion model. [Background technology]

[0002] Medical devices such as guidewires are used for minimally invasive treatment or examination in blood vessels. For example, Patent Documents 1 and 2 disclose simulated blood vessels and lesion models capable of simulating procedures using these medical devices. Patent Document 1 discloses that a lipid equivalent portion is enclosed in the stenosis portion of a simulated blood vessel having a straight tube portion and a stenosis portion. Patent Document 2 discloses a calcification lesion model having a cylindrical calcification lesion portion and a lesion surface layer portion provided in the lumen of the calcification lesion portion. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2004-275682 A [Patent Document 2] JP 2020-190583 A Summary of the Invention [Problem to be solved by the invention]

[0004] Here, it is known that stenosis and occlusion lesions (hereinafter, simply referred to as "lesions") occurring in human lower limb arteries are very long compared to lesions occurring in the coronary arteries of the heart, and calcification often occurs only in a part of the lesion, not in the entire lesion. In this regard, the simulated blood vessel described in Patent Document 1 only takes into account short stenosis occurring in the blood vessel, and there is a problem that long lesions occurring in the arteries of the lower limbs are not taken into account at all. In addition, the simulated blood vessel described in Patent Document 1 cannot simulate lesions including calcification. Furthermore, while the calcification lesion model described in Patent Document 2 can simulate lesions including calcification, there is a problem that it does not take into account long lesions occurring in the arteries of the lower limbs, and cannot simulate lesions in which calcification occurs only in a part. Note that such a problem is not limited to vascular lesion models simulating lesions occurring in the arteries of the lower limbs, but is common to vascular lesion models simulating lesions occurring in the coronary arteries and other arteries.

[0005] The present invention has been made to solve at least some of the above-mentioned problems, and aims to realize a lesion model that is closer to actual clinical use by making it possible to easily adjust the length of a lesion model placed within a vascular model in a vascular lesion model. [Means for solving the problem]

[0006] The present invention has been made to solve at least part of the above-mentioned problems, and can be realized in the following forms.

[0007] (1) According to one aspect of the present invention, there is provided a vascular lesion model comprising a tubular vascular model and a lesion model disposed in an inner cavity of the vascular model, the lesion model having a plurality of lesion areas disposed along a longitudinal direction of the vascular model, the plurality of lesion areas including a first lesion area formed from a first polymeric material and a second lesion area formed from a second polymeric material, and at least one end of the lesion model in the longitudinal direction is fixed to an inner peripheral surface of the vascular model, thereby restricting movement of the lesion model along the longitudinal direction.

[0008] According to this configuration, the length of the lesion model can be easily adjusted by changing the number of first lesions and second lesions included in the multiple lesions arranged along the longitudinal direction of the blood vessel model. In addition, since the multiple lesions include a first lesion formed by a first polymer material and a second lesion formed by a second polymer material, the physical properties of the first and second lesions can be easily adjusted by adjusting the first and second polymer materials. Furthermore, the lesion model has at least one end in the longitudinal direction fixed to the inner circumferential surface of the blood vessel model, so that the movement of the lesion model along the longitudinal direction is restricted. Therefore, even if a medical device in the blood vessel model is pushed toward the lesion model during simulation of a procedure using the blood vessel lesion model, the movement of the lesion model in the longitudinal direction due to the pushing can be suppressed. As a result, according to this configuration, a blood vessel lesion model that realizes a lesion model in an aspect close to actual clinical practice can be provided.

[0009] (2) In the vascular lesion model of the above form, the lesion model may further have a fixing portion for fixing at least one of the ends to an inner surface of the vascular model, the fixing portion being formed from a third polymeric material and harder than both the first lesion portion and the second lesion portion. According to this configuration, at least one end of the lesion model in the longitudinal direction can be fixed to the inner circumferential surface of the blood vessel model by the fixing part. In addition, since the fixing part is harder than both the first lesion part and the second lesion part, the fixing part can simulate compressed and hardened end tissue of a human lesion (e.g., a mass of plaque lesion, a calcified lesion, etc.).

[0010] (3) In the vascular lesion model having the above configuration, the first lesion may be harder than the second lesion. Human lesions often have a mottled distribution of hardness rather than a uniform hardness. With this configuration, the first lesion is harder than the second lesion, so that a lesion model that approximates a human lesion having a non-uniform hardness can be realized.

[0011] (4) In the vascular lesion model of the above aspect, a plurality of the first lesion areas and a plurality of the second lesion areas may be arranged alternately along a longitudinal direction of the vascular model. According to this configuration, the lesion model includes a plurality of first lesions and a plurality of second lesions, so that it is possible to simulate a lesion occurring in a human lower limb artery (a lesion that is very long compared to a lesion occurring in a coronary artery of the heart). In addition, since the plurality of first lesions and the plurality of second lesions are alternately arranged along the longitudinal direction of the blood vessel model, it is possible to realize a lesion model that approximates a human lesion having a mottled hardness distribution along the longitudinal direction.

[0012] (5) In the vascular lesion model of the above form, at least one of the first lesion area and the second lesion area may include a granular calcification area that is harder than both the first polymer material and the second polymer material. According to this configuration, since at least one of the first lesion and the second lesion includes a calcified portion, a lesion including calcification among human lesions can be simulated. Furthermore, if either the first lesion or the second lesion includes a calcified portion, a lesion including calcification in a mottled manner along the longitudinal direction of the blood vessel model can be simulated. If both the first lesion and the second lesion include a calcified portion, a lesion including calcification uniformly along the longitudinal direction of the blood vessel model can be simulated. Furthermore, since the calcified portion is granular and harder than both the first polymer material and the second polymer material, the calcified portion can be configured to more closely resemble a calcified portion included in a human lesion.

[0013] (6) In the vascular lesion model of the above embodiment, the outer peripheral surface of the lesion model facing the vascular model may be fixed to the inner peripheral surface of the vascular model, thereby further restricting circumferential movement of the lesion model. According to this configuration, the outer peripheral surface of the lesion model facing the blood vessel model is fixed to the inner peripheral surface of the blood vessel model, thereby further restricting the circumferential movement of the lesion model. Therefore, when simulating a procedure using the vascular lesion model, even if a medical device in the blood vessel model is rotated while being pushed toward the lesion model, the lesion model can be prevented from moving in the circumferential direction due to the pushing.

[0014] The present invention can be realized in various forms, for example, in the form of a lesion model, a vascular lesion model including a vascular model in addition to a lesion model, an organ model that is equipped with a vascular lesion model and mimics organs such as the heart, liver, brain and lower limbs, a human body simulation device that includes these vascular lesion models and organ models, and a control method for a human body simulation device. [Brief description of the drawings]

[0015] [Figure 1] FIG. 1 is a diagram showing a schematic configuration of a blood vessel simulation device. [Diagram 2] FIG. 2 is an explanatory diagram illustrating a cross-sectional configuration of a vascular lesion model. [Diagram 3] 3 is an explanatory diagram illustrating a cross-sectional configuration taken along line AA in FIG. 2. [Figure 4] FIG. 1 is an explanatory diagram illustrating a method for producing a vascular lesion model. [Diagram 5] FIG. 13 is a diagram illustrating simulation of a procedure using a vascular lesion model. [Figure 6] FIG. 11 is an explanatory diagram illustrating a cross-sectional configuration of a vascular lesion model according to a second embodiment. [Figure 7] FIG. 13 is an explanatory diagram illustrating a cross-sectional configuration of a vascular lesion model according to a third embodiment. [Figure 8] FIG. 13 is an explanatory diagram illustrating a cross-sectional configuration of a vascular lesion model according to a fourth embodiment. [Figure 9] FIG. 13 is an explanatory diagram illustrating a cross-sectional configuration of a vascular lesion model according to a fifth embodiment. [Figure 10] FIG. 23 is an explanatory diagram illustrating a cross-sectional configuration of a vascular lesion model according to a sixth embodiment. [Figure 11] FIG. 23 is an explanatory view illustrating a cross-sectional configuration of a second lesion area in the seventh embodiment. [Figure 12] FIG. 13 is a diagram showing a schematic configuration of a blood vessel simulation device according to an eighth embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] First Embodiment FIG. 1 is a diagram showing a schematic configuration of a blood vessel simulation device 100. The blood vessel simulation device 100 of this embodiment is a device used to simulate a procedure for treating or examining a blood vessel using a medical device. In this embodiment, a penetrating guidewire that penetrates biological tissue with a pointed tip is exemplified as the medical device. However, the medical device may be a plasma guidewire that cuts biological tissue by streamer discharge, or any other device for minimally invasive treatment or examination, such as a well-known catheter or guidewire. The blood vessel simulation device 100 includes a blood vessel model 1, a lesion model 2, an outer tissue model 3, and a circulation pump 9. Hereinafter, the blood vessel model 1 and the lesion model 2 are collectively referred to as "vascular lesion models 1, 2".

[0017] In FIG. 1, the axis passing through the centers of the blood vessel model 1, the lesion model 2, and the outer tissue model 3 is represented by the axis O (dash line). In the following examples, the axis passing through the center of the blood vessel model 1, the axis passing through the center of the lesion model 2, and the axis passing through the center of the outer tissue model 3 all coincide with the axis O. However, the axes passing through the centers of the blood vessel model 1, the lesion model 2, and the outer tissue model 3 may each be different from the axis O. Furthermore, FIG. 1 and the following figures include some parts in which the relative ratio of the sizes of the respective components is depicted differently from the actual ratio, for the sake of convenience of explanation. Also, some parts in which the respective components are depicted in an exaggerated manner are included.

[0018] The blood vessel model 1 is a model simulating a human blood vessel. The blood vessel model 1 has a tubular shape (in other words, a long, approximately cylindrical shape) with openings 1a and 1b at both ends, and a lesion model 2 simulating a human lesion is disposed inside (the lumen 1L shown in FIG. 2). The details of the lesion model 2 will be described later. An outer tissue model 3 simulating human muscle, fat, skin, etc. is disposed outside the blood vessel model 1 so as to surround at least a part of the outer circumferential surface of the blood vessel model 1 (in the illustrated example, the central part excluding both ends of the blood vessel model 1). The outer tissue model 3 is formed of a soft synthetic resin (for example, polyvinyl alcohol: PVA, silicone, etc.). The circulation pump 9 is, for example, a non-volumetric centrifugal pump. The circulation pump 9 is provided in the middle of a flow path connecting the openings 1a and 1b of the blood vessel model 1, and circulates the fluid discharged from the opening 1b and supplies it to the opening 1a.

[0019] FIG. 2 is an explanatory diagram illustrating the cross-sectional configuration of the vascular lesion models 1 and 2. FIG. 2 illustrates mutually orthogonal XYZ axes. The X axis corresponds to the longitudinal direction of the vascular lesion models 1 and 2 (vascular model 1 and lesion model 2), the Y axis corresponds to the height direction of the vascular lesion models 1 and 2, and the Z axis corresponds to the width direction of the vascular lesion models 1 and 2. The left side (-X axis direction) of FIG. 2 is called the "tip side" of the vascular lesion models 1 and 2. When an antegrade approach is adopted, the tip side is the side farther from the insertion site of the medical device (distal, distal side). In addition, the right side (+X axis direction) of FIG. 2 is called the "base side" of the vascular lesion models 1 and 2. When an antegrade approach is adopted, the base side is the side closer to the insertion site of the medical device (proximal, proximal side). These points are common to FIG. 2 and subsequent figures.

[0020] The upper part of FIG. 2 shows the longitudinal cross-sectional configuration of the vascular lesion models 1 and 2. The lower part of FIG. 2 (inside the dashed line balloon) shows an enlarged view of the first lesion part 32 of the lesion model 2 in the upper part of FIG. 2. As shown in the upper part of FIG. 2, the vascular model 1 has a tubular vascular part 10 simulating a human lower limb artery. The vascular part 10 has openings 1a and 1b at both ends, and has an inner lumen 1L through which simulated blood (e.g., a fluid such as physiological saline) flows inside. The vascular part 10 can be made of any material. The vascular part 10 can be made of, for example, PVA, which has similar slipperiness and elasticity to human blood vessels, polysaccharides such as agarose, sodium alginate, cellulose, starch, and glycogen, and resins such as silicone, latex, and polyurethane. The inner and outer diameters and the length in the X-axis direction of the vascular part 10 can be determined arbitrarily.

[0021] The lesion model 2 is a model simulating a human lesion, and is disposed in the lumen 1L of the blood vessel portion 10. As shown in the upper part of FIG. 2, the lesion model 2 has three first lesion portions 31, 32, 33, two second lesion portions 41, 42, and a fixing portion 20. Hereinafter, the first lesion portions 31, 32, 33 and the second lesion portions 41, 42 are collectively referred to simply as "multiple lesion portions". The multiple lesion portions are disposed along the longitudinal direction (i.e., the X-axis direction) of the blood vessel model 1. In the example shown in the upper part of FIG. 2, the three first lesion portions 31, 32, 33 and the two second lesion portions 41, 42 are disposed alternately along the longitudinal direction of the blood vessel model 1. Specifically, in the example in the upper part of Figure 2, three first lesion areas 31, 32, 33 and two second lesion areas 41, 42 are arranged alternately from the +X-axis direction to the -X-axis direction in the order of first lesion area 31, second lesion area 41, first lesion area 32, second lesion area 42, first lesion area 33.

[0022] FIG. 3 is an explanatory diagram illustrating a cross-sectional configuration along line AA in FIG. 2. The configuration of the first lesion 32 will be described with reference to FIG. 3 and the lower part of FIG. 2. The first lesion 32 includes a main body 321 and a calcified portion 322. As shown in FIG. 3, the main body 321 is a cylindrical member having an outer diameter Φ32. The outer diameter Φ32 can be arbitrarily determined as long as it is smaller than the inner diameter Φ10 of the blood vessel model 1. Here, in this embodiment, the "outer diameter" and the "inner diameter" refer to the length of the longest part in an arbitrary cross section when the cross section of the member (or the lumen) is elliptical. The main body 321 is formed of a first polymer material. As the first polymer material, in addition to agarose whose elasticity is similar to that of CTO, gelatin, PVA, urethane, silicone, sodium alginate, cellulose, starch, glycogen, latex, etc. can be used.

[0023] A plurality of calcified portions 322 are embedded in the main body 321. As shown in the lower part of FIG. 2 and FIG. 3, each of the calcified portions 322 is a granular portion having a non-uniform shape and size. That is, the calcified portions 322 can be any shape, such as a sphere, a polyhedron, a cylinder, or a cone. The calcified portions 322 may be thin like a membrane. The lengths La, Lb, and Lc of the calcified portions 322 in the longitudinal direction may be the same or different. The calcified portions 322 can be formed of any material as long as it is harder than the first polymer material and the second polymer material (described later). For example, the calcified portions 322 can be formed of paraffin alone or a material obtained by adding stearic acid to paraffin. In addition to the calcified portions 322, the main body 321 of the first lesion 32 may contain fine particles or nanofibers that function as reflectors.

[0024] The configuration of first lesion area 31 and the configuration of first lesion area 33 are similar to the above-mentioned first lesion area 32. Here, in this embodiment, "similar" and "same" mean roughly the same, and do not necessarily mean strictly the same, but mean that differences due to manufacturing errors and the like are allowed.

[0025] As shown in the upper part of FIG. 2, the second lesion 41 includes a main body 411 and a calcified part 412. The main body 411 is a cylindrical member having an outer diameter smaller than the inner diameter Φ10 of the blood vessel model 1, similar to the main body 321 of the first lesion 32. The outer diameter of the main body 411 and the outer diameter Φ32 of the main body 321 may be the same or different. The main body 411 is formed of a second polymer material different from the first polymer material. As the second polymer material, in addition to agarose whose elasticity is similar to that of CTO, gelatin, PVA, urethane, silicone, sodium alginate, cellulose, starch, glycogen, latex, etc. can be used. Note that "the first polymer material and the second polymer material are different" means not only the case where different materials are used, but also the case where the same material is used and the concentration is changed when gelling (i.e., the case where only the concentration is different is considered to be different materials).

[0026] A plurality of calcified portions 412 are embedded in the main body 411. Each of the calcified portions 412 is granular with a non-uniform shape and size, similar to the calcified portion 322, and can be of any shape, thickness, and length. Similarly to the calcified portion 322, the calcified portion 412 can be formed from paraffin alone or a material in which stearic acid is added to paraffin. The material of the calcified portion 412 and the material of the calcified portion 322 may be the same or different. Note that the main body 411 of the second lesion 41 may contain, in addition to the calcified portion 412, fine particles or nanofibers that function as reflectors. The configuration of the second lesion 42 is the same as that of the second lesion 41 described above.

[0027] Here, the first lesions 31, 32, and 33 in this embodiment are harder than the second lesions 41 and 42. Specifically, for example, when the hardness of the first lesion 31 (the entire first lesion 31 including the calcified portion 312) and the hardness of the second lesion 41 (the entire second lesion 41 including the calcified portion 412) are measured using a known hardness measuring device, the hardness of the first lesion 31 is greater than the hardness of the second lesion 41. In other words, the first lesions 31, 32, and 33 are configured to be harder than the second lesions 41 and 42 by adjusting the above-mentioned first polymer material, the material of the calcified portions 312, 322, and 332, the density of the calcified portions 312, 322, and 332, and the like.

[0028] In the example in the upper part of Fig. 2, the longitudinal length L31 of the first lesions 31, 32, 33 is the same, but the first lesions 31, 32, 33 may have different lengths. The longitudinal length L41 of the second lesions 41, 42 is the same, but the second lesions 41, 42 may have different lengths. The length L31 and the length L41 may be different. The three first lesions 31, 32, 33 and the two second lesions 41, 42 are arranged spaced apart from each other.

[0029] The fixing portion 20 is a member that fixes a plurality of lesions (i.e., first lesions 31, 32, 33 and second lesions 41, 42) in the lumen 1L of the blood vessel model 1. As shown in the upper part of FIG. 2, the fixing portion 20 includes a first fixing portion 21, a second fixing portion 22, and a third fixing portion 23. The longitudinal length L20 of the fixing portion 20 may be determined arbitrarily. In this embodiment, the longitudinal length L20 of the fixing portion 20 is synonymous with the longitudinal length of the lesion model 2.

[0030] The first fixing portion 21 is provided on the proximal side (in the +X-axis direction) of the first lesion portion 31, and is a portion that does not include the first lesion portion 31 on the inside. The proximal ends of the multiple lesion portions (specifically, the ends on the base end side of the first lesion portion 31) are fixed to the inner circumferential surface 12 of the blood vessel model 1 by the first fixing portion 21. In the example shown in the figure, the first fixing portion 21 is provided over the entire circumferential direction of the inner circumferential surface 12 of the blood vessel model 1. The first fixing portion 21 has an outer surface 211 perpendicular to the axis O.

[0031] The second fixing portion 22 is provided on the distal side (-X axis direction) of the first lesion portion 33 and is a portion that does not include the first lesion portion 33 on the inside. The distal end portions of the multiple lesion portions (specifically, the end portions on the tip side of the first lesion portion 33) are fixed to the inner circumferential surface 12 of the blood vessel model 1 by the second fixing portion 22. In the illustrated example, the second fixing portion 22 is provided over the entire circumferential direction of the inner circumferential surface 12 of the blood vessel model 1. In addition, the second fixing portion 22 has an outer surface 221 perpendicular to the axis O. In this way, by being fixed by the first fixing portion 21 and the second fixing portion 22, the movement of the multiple lesion portions (i.e., the first lesion portions 31, 32, 33 and the second lesion portions 41, 42) along the longitudinal direction of the blood vessel model 1 is restricted.

[0032] The third fixing portion 23 is a portion provided between the first fixing portion 21 and the second fixing portion 22, and is a portion that fills the outer peripheral surfaces of the multiple lesions (first lesions 31, 32, 33, second lesions 41, 42) facing the inner peripheral surface 12 of the blood vessel model 1 and the gaps between adjacent lesions. The third fixing portion 23 fixes the outer peripheral surfaces of the multiple lesions facing the blood vessel model 1 (specifically, the outer peripheral surfaces of the first lesions 31, 32, 33 and the outer peripheral surfaces of the second lesions 41, 42) to the inner peripheral surface 12 of the blood vessel model 1. In this way, by being fixed by the third fixing portion 23, the movement of the multiple lesions (i.e., the first lesions 31, 32, 33, the second lesions 41, 42) along the circumferential direction of the blood vessel model 1 is restricted.

[0033] The fixing part 20 is formed of a third polymeric material different from the first and second polymeric materials. As the third polymeric material, in addition to agarose, which has an elasticity similar to that of CTO, gelatin, PVA, urethane, silicone, sodium alginate, cellulose, starch, glycogen, latex, etc. can be used. Note that "the third polymeric material is different from the first and second polymeric materials" means not only the case where different materials are used, but also the case where the same material is used but the concentration is changed when gelling (in this case, it means that it is considered to be a different material).

[0034] Fig. 4 is an explanatory diagram illustrating a method for producing the vascular lesion models 1 and 2. The vascular lesion models 1 and 2 described in Fig. 1 to Fig. 3 can be produced, for example, by the following procedure. Fig. 4(A) shows how a first lesion area 31 and a second lesion area 41 are prepared.

[0035] First, as shown in FIG. 4(A), an arbitrary number of first lesions 31-3n (n is an arbitrary natural number, hereinafter, n=3 will be used as an example) and an arbitrary number of second lesions 41-4m (m is an arbitrary natural number, hereinafter, m=2 will be used as an example) are prepared. The first lesion 31 can be formed by pouring a gelled first polymer material into a cylindrical mold, embedding an arbitrary number of calcified portions 312 in the gel before the gel hardens, hardening the gel, and demolding the mold. The second lesion 41 can be formed by pouring a gelled second polymer material into a cylindrical mold, embedding an arbitrary number of calcified portions 412 in the gel before the gel hardens, and demolding the gel.

[0036] FIG. 4(B) shows how the blood vessel model 1 is prepared. Next, as shown in FIG. 4(B), a tubular blood vessel model 1 made of any polymeric material is prepared. FIG. 4(C) shows how the first lesions 31, 32, 33 and the second lesions 41, 42 are arranged in the blood vessel model 1. The first lesions 31-33 and the second lesions 41-42 prepared in FIG. 4(A) are arranged in the lumen 1L of the blood vessel model 1 prepared in FIG. 4(B). In the example of FIG. 4(C), the first lesions 31-33 and the second lesions 41-42 are arranged alternately from the opening 1a side to the opening 1b side, with a gap between them. FIG. 4(D) shows how the fixing part 20 is formed. Next, as shown in FIG. 4(D), a gelled third polymeric material is poured and hardened.

[0037] In the example of FIG. 4, the number of first lesions 31-3n is three (n=3), and the number of second lesions 41-4m is two (m=2). However, according to the method described in FIG. 4, the number of first lesions 31-3n and the number of second lesions 41-4m can be easily changed. As a result, the length L20 (upper part of FIG. 2) of the lesion model 2 along the longitudinal direction (X-axis direction) of the blood vessel model 1 can be easily changed. Therefore, by increasing the number of first lesions 31-3n and the number of second lesions 41-4m, a long lesion model 2 (i.e., a lesion model 2 simulating a lesion occurring in a human lower limb artery) can be easily produced.

[0038] FIG. 5 is a diagram for explaining the simulation of a procedure using the vascular lesion models 1 and 2. Using the vascular simulation device 100 including the vascular lesion models 1 and 2 as described above, the surgeon can simulate a procedure using a medical device on the lesion model 2. For example, the surgeon operates the circulation pump 9 to circulate a fluid (e.g., simulated blood such as physiological saline) through the vascular model 1, cuts a part of the vascular model 1, and inserts a penetration guidewire 8 into the lumen 1L of the vascular model 1. Then, the surgeon delivers the tip of the penetration guidewire 8 to the position of the lesion model 2. For example, as shown in the figure, the surgeon performs an antegrade approach in which the tip of the penetration guidewire 8 approaches the lesion model 2 from the side of the first fixing portion 21. Then, the surgeon pushes in the penetration guidewire 8 to penetrate the first fixing portion 21, and then penetrates the first lesion 31, the second lesion 42, the first lesion 32, etc., thereby simulating a procedure of opening the lesion model 2. In the example of FIG. 5, penetration using the penetration guidewire 8 has been described, but the lesion model 2 may be opened by other methods (for example, ablation using a plasma guidewire).

[0039] As described above, according to the first embodiment, the lesion model 2 of the vascular lesion model 1, 2 can easily adjust the length L20 (FIG. 2) of the lesion model 2 by changing the number of first lesions 31-3n and second lesions 41-4m included in the multiple lesions arranged along the longitudinal direction (X-axis direction) of the blood vessel model 1. Furthermore, since the multiple lesions include the first lesions 31-3n formed from a first polymer material and the second lesions 41-4m formed from a second polymer material, the physical properties (mechanical properties, thermal properties, electrical properties, magnetic properties, optical properties) of the first lesions 31-3n and the second lesions 41-4m can easily be adjusted by adjusting the first and second polymer materials. Furthermore, the lesion model 2 has both longitudinal ends fixed to the inner circumferential surface 12 of the blood vessel model 1, so that the movement of the lesion model 2 along the longitudinal direction is restricted. 5, when simulating a procedure using the vascular lesion models 1 and 2, even if the medical device 8 in the vascular model 1 is pushed toward the lesion model 2, the lesion model 2 can be prevented from moving in the longitudinal direction due to the pushing. As a result, the configuration of the first embodiment can provide the vascular lesion models 1 and 2 that realize a lesion model 2 in an aspect close to that in actual clinical practice.

[0040] According to the first embodiment, the outer peripheral surface of the lesion model 2 facing the blood vessel model 1 is fixed to the inner peripheral surface 12 of the blood vessel model 1 by the third fixing portion 23, so that the movement of the lesion model 2 in the circumferential direction is further restricted. Therefore, as described in FIG. 5, even if the medical device 8 in the blood vessel model 1 is rotated while being pushed toward the lesion model 2 when simulating a procedure using the blood vessel lesion models 1 and 2, the movement of the lesion model 2 in the circumferential direction accompanying the pushing can be suppressed. In addition, since the third fixing portion 23 also fills the gap between adjacent lesions, the movement of the lesion model 2 in the longitudinal direction and the circumferential direction can be further suppressed, and a false lumen occurring in an actual blood vessel and lesion can be simulated by generating a crack between the blood vessel model 1 and the fixing portion 20 accompanying the pushing of the medical device 8.

[0041] Furthermore, according to the first embodiment, both longitudinal ends of the lesion model 2 can be fixed to the inner circumferential surface 12 of the blood vessel model 1 by the first fixing portion 21 and the second fixing portion 22 of the fixing part 20. Moreover, since the first fixing portion 21 and the second fixing portion 22 are harder than both the first lesion portions 31-3n and the second lesion portions 41-4m, such first fixing portion 21 and second fixing portion 22 can simulate compressed and hardened end tissues of human lesions (for example, a mass of plaque lesion, a calcified lesion, etc.).

[0042] Here, human lesions often have a mottled distribution of hardness rather than a uniform hardness. In this regard, according to the vascular lesion models 1 and 2 of the first embodiment, the first lesions 31-3n are harder than the second lesions 41-4m, so that the lesion model 2 can be realized that is similar to a human lesion having a non-uniform hardness. Furthermore, according to the vascular lesion models 1 and 2 of the first embodiment, the lesion model 2 includes a plurality of first lesions 31-3n and a plurality of second lesions 41-4m, so that a lesion occurring in a human lower limb artery (a lesion that is very long compared to a lesion occurring in a coronary artery of the heart) can be simulated. Furthermore, the plurality of first lesions 31-3n and the plurality of second lesions 41-4m are alternately arranged along the longitudinal direction of the vascular model 1, so that the lesion model 2 can be realized that is similar to a human lesion having a mottled distribution of hardness along the longitudinal direction.

[0043] Furthermore, according to the first embodiment, the first lesions 31-3n and the second lesions 41-4m include the calcified portions 312, 412, so that lesions including calcification among human lesions can be simulated. In this manner, if the first lesions 31-3n and the second lesions 41-4m are configured to include the calcified portions 312, 412, it is possible to simulate a lesion including calcification uniformly along the longitudinal direction of the blood vessel model 1. Furthermore, since the calcified portions 312, 412 are granular and harder than both the first polymer material and the second polymer material, the calcified portions 312, 412 can be configured to more closely resemble the calcified portions included in human lesions.

[0044] <Second embodiment> FIG. 6 is an explanatory diagram illustrating the cross-sectional configuration of the vascular lesion model 1, 2A of the second embodiment. The vascular simulation device 100A of the second embodiment includes the vascular lesion model 1, 2A instead of the vascular lesion model 1, 2. The vascular lesion model 1, 2A has the lesion model 2A instead of the lesion model 2 in the configuration described in the first embodiment. The lesion model 2A has the fixing part 20A instead of the fixing part 20 in the configuration described in the first embodiment. The fixing part 20A has only the first fixing part 21 that is provided on the proximal side (+X-axis direction) of the first lesion part 31 and fixes the proximal end of the multiple lesion parts (the end on the base end side of the first lesion part 31) to the inner circumferential surface 12 of the vascular model 1. In other words, the fixing part 20A does not have the second fixing part 22 and the third fixing part 23 described in the first embodiment.

[0045] In this way, the configuration of lesion model 2A can be modified in various ways, and can be configured such that only one end of a plurality of lesions (i.e., first lesions 31, 32, 33 and second lesions 41, 42) is fixed. Although Fig. 6 shows an example in which the proximal ends of a plurality of lesions are fixed, it is also possible to configure such that only the distal ends of a plurality of lesions (the end on the tip side of first lesion 33) are fixed.

[0046] The vascular lesion models 1, 2A of the second embodiment can also achieve the same effects as those of the first embodiment. Specifically, as in FIG. 5, when an antegrade approach is performed in which the tip of the penetration guidewire 8 is brought close to the lesion model 2A from the side of the first fixing part 21, the first fixing part 21 comes into contact with the penetration guidewire 8, thereby suppressing the longitudinal movement of the lesion model 2A. When a retrograde approach is performed in which the tip of the penetration guidewire 8 is brought close to the lesion model 2A from the side of the first lesion 33, the first fixing part 21 supports the multiple lesions pushed in the +X-axis direction by the penetration guidewire 8, thereby suppressing the longitudinal movement of the lesion model 2A.

[0047] <Third embodiment> FIG. 7 is an explanatory diagram illustrating the cross-sectional configuration of the vascular lesion models 1, 2B of the third embodiment. The upper part of FIG. 7 shows the longitudinal cross-sectional configuration of the vascular lesion models 1, 2B. The lower part of FIG. 7 (inside the dashed line balloon) shows the transverse cross-sectional configuration of the vascular lesion models 1, 2B at line BB. The vascular simulation device 100B of the third embodiment includes vascular lesion models 1, 2B instead of the vascular lesion models 1, 2. The vascular lesion models 1, 2B have a lesion model 2B instead of the lesion model 2 in the configuration described in the first embodiment. The lesion model 2B has a fixing part 20B instead of the fixing part 20 in the configuration described in the first embodiment.

[0048] The fixing portion 20B includes a first fixing portion 21B and a third fixing portion 23B. The first fixing portion 21B is provided on the proximal side (in the +X-axis direction) of the first lesion portion 31, and is a portion that does not include the first lesion portion 31 on the inside. The proximal ends of the multiple lesion portions (specifically, the ends on the base end side of the first lesion portion 31) are fixed to the inner circumferential surface 12 of the blood vessel model 1 by the first fixing portion 21B. As shown in the upper part of FIG. 7, the first fixing portion 21B is provided on a part of the inner circumferential surface 12 of the blood vessel model 1 in the circumferential direction. Therefore, in the part where the first fixing portion 21B is provided, there is a part in the circumferential direction of the blood vessel model 1 where a gap SP exists between the inner circumferential surface 12 and the first fixing portion 21B. In the blood vessel lesion models 1 and 2B of the third embodiment, a fluid can flow through this gap SP. In addition, the outer surface 211B of the first fixing portion 21B is not perpendicular to the axis O, but is inclined.

[0049] The third fixing portion 23B is a portion provided on the distal side (-X-axis direction) of the first fixing portion 21B, and fills a portion of the outer peripheral surface facing the inner peripheral surface 12 of the blood vessel model 1 among the multiple lesions (first lesions 31, 32, 33, second lesions 41, 42) and a portion of the gap between adjacent lesions. As shown in the lower part of FIG. 7, the third fixing portion 23B is provided on a portion of the inner peripheral surface 12 of the blood vessel model 1 in the circumferential direction. Therefore, in the portion where the third fixing portion 23B is provided, a gap SP exists between the inner peripheral surface 12 and the multiple lesions and the third fixing portion 23B in the circumferential part of the blood vessel model 1. Note that the range of the inner peripheral surface 12 covered by the first fixing portion 21B and the third fixing portion 23B in the blood vessel model 1 can be determined arbitrarily.

[0050] In this way, the configuration of the lesion model 2B can be modified in various ways, and the shape of the first fixing part 21B can be changed arbitrarily. Specifically, the first fixing part 21B can have an outer surface 211B inclined with respect to the axis O, and does not have to be provided on the entire inner circumferential surface 12 of the blood vessel model 1 in the circumferential direction. This also applies to the second fixing part 22 when the second fixing part 22 is provided on the lesion model 2B. The shape of the third fixing part 23B can be changed arbitrarily. Specifically, the third fixing part 23B does not have to be provided on the entire inner circumferential surface 12 of the blood vessel model 1 in the circumferential direction. The vascular lesion models 1 and 2B of the third embodiment can also achieve the same effects as those of the first embodiment described above. In addition, the vascular lesion models 1 and 2B of the third embodiment can provide a lesion model 2B that simulates a stenosis lesion.

[0051] <Fourth embodiment> FIG. 8 is an explanatory diagram illustrating the cross-sectional configuration of the vascular lesion models 1 and 2C of the fourth embodiment. The vascular simulation device 100C of the fourth embodiment includes vascular lesion models 1 and 2C instead of the vascular lesion models 1 and 2. The vascular lesion models 1 and 2C have a lesion model 2C instead of the lesion model 2 in the configuration described in the first embodiment. The lesion model 2C has three first lesion areas 31C, 32C, and 33C and two second lesion areas 41C and 42C in the configuration described in the first embodiment. These multiple lesion areas are arranged in the order of the second lesion area 41C, the second lesion area 42C, the first lesion area 31C, the first lesion area 32C, and the first lesion area 33C from the +X-axis direction toward the -X-axis direction.

[0052] In this way, the configuration of lesion model 2C can be modified in various ways, and first lesion areas 31C, 32C, 33C and second lesion areas 41C, 42C do not have to be arranged alternately. In the illustrated example, three first lesion areas 31C, 32C, 33C and two second lesion areas 41C, 42C and an example of their arrangement are shown. However, the number n of first lesion areas and the number m of second lesion areas may be changed arbitrarily. In addition, the arrangement of the n first lesion areas and the m second lesion areas may also be changed arbitrarily.

[0053] The vascular lesion models 1 and 2C of the fourth embodiment can also achieve the same effects as those of the first embodiment. As described in the first embodiment, since "the hardness of the first lesion 31 is greater than the hardness of the second lesion 41," in the lesion model 2C of the fourth embodiment, the number n of one lesion and the number m of second lesions in the lesion model 2C, and the arrangement of the n first lesions and the m second lesions can be adjusted to produce lesion models 2C having various types of hardness distributions.

[0054] <Fifth embodiment> 9 is an explanatory diagram illustrating a cross-sectional configuration of the vascular lesion models 1, 2D of the fifth embodiment. The vascular simulation device 100D of the fifth embodiment includes vascular lesion models 1, 2D instead of the vascular lesion models 1, 2. The vascular lesion models 1, 2D have a lesion model 2D instead of the lesion model 2 in the configuration described in the first embodiment. The lesion model 2D has a second lesion portion 41D instead of the second lesion portion 41 and a second lesion portion 42D instead of the second lesion portion 42 in the configuration described in the first embodiment. The second lesion portion 41D and the second lesion portion 42D are composed of only the main body portions 411, 421 without including the calcified portions 412, 422.

[0055] In this way, the configuration of lesion model 2D can be modified in various ways, and it may be configured to have second lesions 41D, 42D that do not include calcifications. In the illustrated example, the second lesions 41D, 42D do not include calcifications, but first lesions 31, 32, 33 may not include calcifications.

[0056] The vascular lesion models 1 and 2D of the fifth embodiment can achieve the same effect as the first embodiment. Here, a lesion not including a calcification is softer than a lesion including a calcification. Therefore, according to the configuration of the fifth embodiment, a lesion model 2D having a wider hardness distribution can be produced by mixing the second lesions 41D and 42D not including a calcification with the first lesions 31, 32, and 33 including the calcifications 312, 322, and 332. In other words, as described in the vascular lesion models 1 and 2D of the fifth embodiment, if either the first lesions 31, 32, and 33 or the second lesions 41D and 42D are configured to include a calcification, a lesion including calcifications in a mottled manner along the longitudinal direction of the vascular model 1 can be simulated.

[0057] Sixth Embodiment FIG. 10 is an explanatory diagram illustrating the cross-sectional configuration of the vascular lesion models 1 and 2E of the sixth embodiment. The vascular simulation device 100E of the sixth embodiment includes the vascular lesion models 1 and 2E instead of the vascular lesion models 1 and 2. The vascular lesion models 1 and 2E have the lesion model 2E instead of the lesion model 2D in the configuration described in the fifth embodiment. The lesion model 2E has the first lesion 31E instead of the first lesion 31, has the first lesion 32E instead of the first lesion 32, and has the first lesion 33E instead of the first lesion 33 in the configuration described in the fifth embodiment. The first lesions 31E, 32E, and 33E are all composed of only the main body parts 311, 321, and 331, without including the calcified parts 312, 322, and 332.

[0058] In this way, the configuration of the lesion model 2E can be modified in various ways, and the first lesions 31E, 32E, and 33E and the second lesions 41D and 42D may be configured to not include a calcified area. E Hardness > Second Lesion 41 D Since the hardness distribution of lesion model 2E is "hardness of the first lesion portion n and the number of second lesion portions m in lesion model 2E, and the arrangement of the n first lesion portions and the arrangement of the m second lesion portions, lesion model 2E having various types of hardness distribution can be produced.

[0059] The vascular lesion models 1 and 2E of the sixth embodiment can also provide the same effects as those of the first embodiment. Moreover, the lesion model 2E of the sixth embodiment can reduce the effort and cost required for producing the first lesion areas 31E, 32E, and 33E and the second lesion areas 41D and 42D, so that the lesion model 2E can be produced more easily and at lower cost.

[0060] Seventh embodiment FIG. 11 is an explanatory diagram illustrating a cross-sectional configuration of the second lesion portion 41F of the seventh embodiment. The blood vessel simulation device 100F of the seventh embodiment includes a blood vessel lesion model 1, 2F instead of the blood vessel lesion model 1, 2. The blood vessel lesion model 1, 2F has a lesion model 2F instead of the lesion model 2 in the configuration described in the first embodiment. The lesion model 2F has a second lesion portion 41F instead of the second lesion portion 41 in the configuration described in the first embodiment. As shown in FIG. 11, the second lesion portion 41F does not have the calcified portion 412 described in the first embodiment, and includes a central portion 412F harder than the main body portion 411 inside the main body portion 411. In the illustrated example, the central portion 412F is a flattened sphere, but may have any shape. The central portion 412F may be formed, for example, by using the same material as the main body portion 411 and making the concentration of the material thicker when gelling, or may be formed using a material different from the main body portion 411.

[0061] In this way, the configuration of the second lesion portion 41F can be modified in various ways, and the calcified portion 412 may be replaced by a central portion 412F harder than the main body portion 411. This also applies to the second lesion portion 42 and the first lesion portions 31, 32, and 33. The vascular lesion models 1 and 2F of the seventh embodiment can also achieve the same effects as those of the first embodiment described above.

[0062] Eighth embodiment FIG. 12 is a diagram showing a schematic configuration of a blood vessel simulation device 100G of the eighth embodiment. The blood vessel simulation device 100G of the eighth embodiment does not include the outer tissue model 3 and the circulation pump 9 in the configuration described in the first embodiment. The blood vessel lesion models 1 and 2 of the blood vessel simulation device 100G may be used after being moistened with a fluid (e.g., simulated blood such as physiological saline) or may be used in a dry state. In addition, the blood vessel simulation device 100G may include, for example, a water tank capable of being filled with a fluid, and the blood vessel lesion models 1 and 2 may be used in a state of being placed in the water tank filled with the fluid. The blood vessel simulation device 100G of the eighth embodiment can also achieve the same effects as those of the first embodiment described above.

[0063] <Modifications of this embodiment> The present invention is not limited to the above-described embodiment, and can be embodied in various forms without departing from the spirit and scope of the invention. For example, the following modifications are also possible.

[0064] [Variation 1] In the above first to eighth embodiments, an example of the configuration of the blood vessel simulation device 100, 100A to 100G has been shown. However, the configuration of the blood vessel simulation device 100 can be modified in various ways. For example, the blood vessel simulation device 100 may have an organ model imitating an organ such as a heart, a liver, a brain, or a lower limb. In this case, the blood vessel lesion models 1 and 2 may be provided on the outside or inside of the organ model. For example, the blood vessel simulation device 100 may include a pulsating pump for adding a motion simulating pulsation to the fluid circulated by the circulation pump 9. For the pulsating pump, for example, a positive displacement reciprocating pump or a rotary pump rotated at a low speed can be used.

[0065] [Variation 2] In the above first to eighth embodiments, one example of the configuration of the vascular lesion models 1, 2, 2A to 2F has been shown. However, the configuration of the vascular lesion models 1, 2 can be modified in various ways. For example, the vascular model 1 may have any shape, such as a straight shape, a curved shape, a meandering shape, or the like. For example, the outer peripheral surface 11 or the inner peripheral surface 12 of the vascular model 1 may be coated with a hydrophilic or hydrophobic resin.

[0066] [Variation 3] In the above first to eighth embodiments, one example of the configuration of the lesion model 2, 2A to 2F has been shown. However, the configuration of the lesion model 2 can be modified in various ways. For example, in the lesion model 2, the adjacent first lesions 31 to 3n and the second lesions 41 to 4m may be arranged without any gaps and may be in contact with each other. For example, the first lesions 31 to 3n and the second lesions 41 to 4m may differ from each other in elements other than hardness (for example, shape, size). For example, at least one of the first lesions 31 to 3n and the second lesions 41 to 4m may be configured as a lesion that blocks the lumen 1L of the blood vessel model 1 by making the outer diameter the same as the inner diameter Φ10 of the blood vessel model 1.

[0067] For example, the first lesions 31-3n and the second lesions 41-4m may have the same hardness. For example, the fixation portion 20 may have the same hardness as either one of the first lesions 31-3n and the second lesions 41-4m, or may be softer than either one of the first lesions 31-3n and the second lesions 41-4m.

[0068] [Variations 4 ] The configurations of the blood vessel simulation devices 100, 100A to 100G or the blood vessel lesion models 1, 2, 2A to 2F of the first to eighth embodiments, and the above-mentioned modified example 1 ~3The configurations of the blood vessel simulation devices 100, 100A to 100G or the vascular lesion models 1, 2, 2A to 2F may be appropriately combined. For example, the fixing unit 20 described in any of the second and third embodiments and the first and second lesion units 31 to 3n, 41 to 4m described in any of the fourth to seventh embodiments may be combined to configure the vascular lesion models 1 and 2. For example, the vascular simulation device 100G of the eighth embodiment may use the vascular lesion models 1 and 2 described in any of the first to seventh embodiments.

[0069] Although the present aspect has been described above based on the embodiment and modified examples, the above-mentioned embodiment of the aspect is intended to facilitate understanding of the present aspect and does not limit the present aspect. The present aspect may be modified or improved without departing from the spirit and scope of the claims, and equivalents are included in the present aspect. Furthermore, if a technical feature is not described as essential in this specification, it may be deleted as appropriate. [Explanation of symbols]

[0070] 1,2…Vascular lesion model 1. Blood vessel model 2, 2A-2F: Lesion model 3…External tissue model 8...Medical devices (penetration guidewires) 9…Circulation pump 10...Vascular area 11…Outer surface 12...Inner peripheral surface 20,20A,20B…Fixed part 21,21B…1st fixed part 22…Second fixed part 23,23B…Third fixed part 31, 31C, 31E…First lesion 32, 32C, 32E…First lesion 33, 33C, 33E…First lesion 41, 41C, 41D, 41F: Second lesion 42, 42C, 42D: Second lesion 100,100A~100G...Blood vessel simulation device 211,211B…outer side 221…Outer side 311,321…Main body part 312,322…Limestone 411…Ontology Department 412…Lime 412F…Center

Claims

1. A vascular lesion model, comprising: A tubular blood vessel model; A lesion model disposed in the lumen of the blood vessel model; Equipped with The lesion model comprises: a plurality of lesions arranged along a longitudinal direction of the blood vessel model, the plurality of lesions including a first lesion formed from a first polymer material and a second lesion formed from a second polymer material; a fixing portion that restricts movement of the lesion model along the longitudinal direction by fixing at least one end portion in the longitudinal direction to an inner circumferential surface of the blood vessel model, the fixing portion being made of a third polymer material and harder than both the first lesion portion and the second lesion portion; A vascular lesion model, wherein the first lesion area and the second lesion area are connected by the fixing part extending in the longitudinal direction.

2. The vascular lesion model according to claim 1, The first lesion is harder than the second lesion.

3. The vascular lesion model according to claim 1 or 2, In the lesion model, a plurality of the first lesion areas and a plurality of the second lesion areas are alternately arranged along the longitudinal direction of the blood vessel model.

4. The vascular lesion model according to any one of claims 1 to 3, A vascular lesion model, wherein at least one of the first lesion and the second lesion includes a granular calcification that is harder than both the first polymer material and the second polymer material.

5. The vascular lesion model according to any one of claims 1 to 4, A vascular lesion model, wherein the lesion model's outer peripheral surface facing the vascular model is fixed to the inner peripheral surface of the vascular model, thereby further restricting circumferential movement of the lesion model.

6. The vascular lesion model according to claim 1, A vascular lesion model, wherein a gap between the first lesion area and the second lesion area is filled by the fixing part.

7. The vascular lesion model according to claim 6, A vascular lesion model, wherein the length of the fixing portion arranged between the first lesion and the second lesion in the longitudinal direction is shorter than the length of the first lesion and shorter than the length of the second lesion.

8. The vascular lesion model according to any one of claims 1 to 7, the first lesion includes a granular calcification that is harder than both the first polymeric material and the second polymeric material; The second lesion does not include the calcified portion, The first lesion is harder than the second lesion.

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