Vascular lesion model

Abstract

A blood vessel disease model has a tube-shaped blood vessel model and a disease model arranged in an inner cavity of the blood vessel model. The disease model has a plurality of disease portions arranged in a length direction of the blood vessel model, the plurality of disease portions including a first disease portion formed of a first polymer material and a second disease portion formed of a second polymer material, and the disease model is restricted from moving in the length direction by fixing at least one end portion in the length direction to an inner peripheral surface of the blood vessel model.

Description

Technical Field

[0001] This invention relates to a vascular lesion model. Background Technology

[0002] Medical devices such as guidewires are used for minimally invasive treatments or examinations within blood vessels. For example, Patent Documents 1 and 2 disclose a simulated blood vessel and lesion model capable of simulating surgeries performed using these medical devices. Patent Document 1 discloses a method of sealing a lipid equivalent portion in the narrow portion of a simulated blood vessel having a straight section and a narrow section. Patent Document 2 discloses a calcified lesion model having a cylindrical calcified lesion site and a lesion surface portion disposed within the lumen of the calcified lesion site.

[0003] Existing technical documents

[0004] Patent documents

[0005] Patent Document 1: Japanese Patent Application Publication No. 2004-275682

[0006] Patent Document 2: Japanese Patent Application Publication No. 2020-190583 Summary of the Invention

[0007] The problem that the invention aims to solve

[0008] Here, it is known that stenosis and occlusion lesions (hereinafter also referred to as "lesions") arising in the arteries of the human lower limbs are very long compared to lesions arising in the coronary arteries of the heart, and are often calcified only in a part of the lesion rather than the entire lesion. In this respect, the simulated blood vessel described in Patent Document 1 has the following problem: it only considers short stenosis arising within the blood vessel, and does not consider long lesions arising in the lower limb arteries. Furthermore, the simulated blood vessel described in Patent Document 1 cannot simulate lesions containing calcification. In addition, the calcified lesion model described in Patent Document 2 can simulate lesions containing calcification, but it has the following problem: it does not consider long lesions arising in the lower limb arteries, and cannot simulate lesions where only a portion is calcified. It should be noted that such problems are not limited to vascular lesion models simulating lesions arising in the lower limb arteries, but are common to vascular lesion models simulating lesions arising in the coronary arteries and other arteries.

[0009] This invention was made to solve at least part of the above-mentioned problems, and its purpose is to achieve a lesion model that closely resembles the actual clinical morphology by being able to easily adjust the length of the lesion model configured within the vascular model.

[0010] Methods for solving problems

[0011] This invention was made to solve at least a part of the above-mentioned problems and can be implemented in the following ways.

[0012] (1) According to one aspect of the present invention, a vascular lesion model is provided. The vascular lesion model comprises: a tubular vascular model; and a lesion model disposed within the lumen of the vascular model, the lesion model having a plurality of lesion portions disposed along the length direction of the vascular model, the plurality of lesion portions including a first lesion portion formed of a first polymeric material and a second lesion portion formed of a second polymeric material, the lesion model restricting movement along the length direction by fixing at least one end in the length direction to the inner peripheral surface of the vascular model.

[0013] According to this structure, the length of the lesion model can be easily adjusted by changing the number of first and second lesion portions included in the plurality of lesion portions arranged along the length direction of the blood vessel model. Furthermore, since the plurality of lesion portions include first lesion portions formed of a first polymer material and second lesion portions formed of a second polymer material, the physical properties of the first and second lesion portions can be easily adjusted by adjusting the first and second polymer materials. In addition, the lesion model restricts movement along the length direction by fixing at least one end in the length direction to the inner circumferential surface of the blood vessel model. Therefore, when simulating surgery using the vascular lesion model, even when a medical device within the blood vessel model is pushed towards the lesion model, movement of the lesion model along the length direction due to the pushing can be suppressed. As a result, according to this structure, a vascular lesion model that achieves a lesion model close to the real clinical morphology can be provided.

[0014] (2) In the vascular lesion model of the above method, the lesion model may also have a fixing part, which fixes the end of at least one of the lesions to the inner peripheral surface of the vascular model. The fixing part is formed of a third polymer material, which is harder than both the first lesion part and the second lesion part.

[0015] According to this structure, at least one end of the lesion model in the length direction can be fixed to the inner circumferential surface of the blood vessel model via the fixing part. In addition, since the fixing part is harder than both the first and second lesion parts, it is possible to simulate the compressed and hardened end tissue in human lesions (e.g., the mass of a plaque lesion or a calcified lesion).

[0016] (3) In the vascular lesion model described above, the first lesion may be harder than the second lesion.

[0017] Human lesions often exhibit uneven hardness and a patchy hardness distribution. Based on this structure, since the first lesion is harder than the second lesion, it is possible to achieve a lesion model that approximates the uneven hardness of human lesions.

[0018] (4) In the vascular lesion model described above, multiple first lesion portions and multiple second lesion portions may be alternately arranged along the length of the vascular model.

[0019] Based on this structure, since the lesion model includes multiple first lesion sections and multiple second lesion sections, it is possible to simulate lesions arising from the arteries of the human lower limbs (lesions that are much longer than those arising from the coronary arteries of the heart). Furthermore, since the multiple first lesion sections and multiple second lesion sections are alternately arranged along the length of the vascular model, it is possible to achieve a lesion model that approximates human lesions with a patchy hardness distribution along the length direction.

[0020] (5) In the vascular lesion model described above, at least one of the first lesion and the second lesion may also include granular calcifications, which are harder than both the first polymer material and the second polymer material.

[0021] According to this structure, since at least one of the first and second lesion portions includes a calcified portion, it is possible to simulate calcified lesions in human lesions. Furthermore, if the structure includes a calcified portion in either the first or second lesion portion, it is possible to simulate lesions with patchy calcification along the length of the vascular model. If both the first and second lesion portions include calcified portions, it is possible to simulate lesions with uniform calcification along the length of the vascular model. Moreover, since the calcified portion is granular and harder than both the first and second polymer materials, the structure of the calcified portion can serve as a structure approximating the calcified portions contained in human lesions.

[0022] (6) In the vascular lesion model described above, the lesion model may further restrict the circumferential movement of the lesion model by fixing the outer peripheral surface facing the vascular model to the inner peripheral surface of the vascular model.

[0023] According to this structure, the lesion model further restricts its circumferential movement by fixing its outer peripheral surface, which faces the blood vessel model, to the inner peripheral surface of the blood vessel model. Therefore, when simulating surgery using the blood vessel lesion model, even when the medical device in the blood vessel model is rotated while being pushed towards the lesion model, the circumferential movement of the lesion model due to the pushing can be suppressed.

[0024] It should be noted that the present invention can be implemented in various forms, for example, in the following ways: lesion model, vascular lesion model including vascular model in addition to lesion model, organ model having vascular lesion model and imitating organs such as heart, liver, brain, and lower limbs, human body simulation device including these vascular lesion models and organ models, and control method of human body simulation device, etc. Attached Figure Description

[0025] Figure 1 This is a diagram showing the schematic structure of a blood vessel simulation device.

[0026] Figure 2 This is an illustrative diagram illustrating the cross-sectional structure of a vascular lesion model.

[0027] Figure 3 This is an example. Figure 2 An explanatory diagram of the cross-sectional structure at line AA.

[0028] Figure 4 This is an illustrative diagram illustrating the method for manufacturing a vascular lesion model.

[0029] Figure 5 This is a diagram illustrating a surgical simulation using a vascular lesion model.

[0030] Figure 6 This is an explanatory diagram illustrating the cross-sectional structure of the vascular lesion model according to the second embodiment.

[0031] Figure 7 This is an explanatory diagram illustrating the cross-sectional structure of the vascular lesion model according to the third embodiment.

[0032] Figure 8 This is an explanatory diagram illustrating the cross-sectional structure of the vascular lesion model according to the fourth embodiment.

[0033] Figure 9 This is an explanatory diagram illustrating the cross-sectional structure of the vascular lesion model according to the fifth embodiment.

[0034] Figure 10 This is an explanatory diagram illustrating the cross-sectional structure of the vascular lesion model according to the sixth embodiment.

[0035] Figure 11 This is an explanatory diagram illustrating the cross-sectional structure of the second lesion portion according to the seventh embodiment.

[0036] Figure 12 This is a diagram showing the schematic structure of the blood vessel simulation device according to the eighth embodiment. Detailed Implementation

[0037] <First Embodiment>

[0038] Figure 1This is a diagram showing a schematic structure of the vascular simulation device 100. The vascular simulation device 100 of this embodiment is a device for simulating surgical procedures performed on blood vessels using medical equipment. In this embodiment, a penetrating guidewire that penetrates biological tissue through a pointed tip is exemplified as the medical equipment. However, the medical equipment may also use a plasma guidewire that cuts biological tissue using streamer discharge; in addition, any known catheter or guidewire used for minimally invasive treatment or examination may be used. The vascular simulation device 100 includes a vascular model 1, a lesion model 2, an lateral tissue model 3, and a circulation pump 9. Hereinafter, the vascular model 1 and the lesion model 2 will be collectively referred to as "vascular lesion models 1 and 2".

[0039] exist Figure 1 In the diagram, the axes passing through the centers of vessel model 1, lesion model 2, and lateral tissue model 3 are represented by axis O (a single-dot dashed line). In the following examples, the axes passing through the centers of vessel model 1, lesion model 2, and lateral tissue model 3 all coincide with axis O. However, the axes passing through the centers of each of the three models can also differ from axis O. Furthermore, in... Figure 1 In the subsequent diagrams, for ease of explanation, the relative sizes of the constituent components are described as different from the actual sizes. Additionally, portions of each constituent component are described in an exaggerated manner.

[0040] Blood vessel model 1 is a model simulating human blood vessels. Blood vessel model 1 is a tube-shaped structure (in other words, a long, roughly cylindrical shape) with openings 1a and 1b at both ends, inside ( Figure 2 The cavity 1L shown is equipped with a lesion model 2 simulating a human lesion. Details of the lesion model 2 will be described later. Outside the vascular model 1, an outer tissue model 3 simulating human muscle, fat, and skin is arranged to surround at least a portion of the outer periphery of the vascular model 1 (in the illustrated example, excluding the central portions at both ends of the vascular model 1). The outer tissue model 3 is formed of a soft synthetic resin (e.g., polyvinyl alcohol (PVA), silicone, etc.). The circulation pump 9 is, for example, a non-volumetric centrifugal pump. The circulation pump 9 is positioned midway through the flow path connecting the openings 1a and 1b of the vascular model 1, circulating the fluid discharged from opening 1b and supplying it to opening 1a.

[0041] Figure 2 These are illustrative diagrams illustrating the cross-sectional structures of vascular lesion models 1 and 2. Figure 2The middle figure shows the mutually orthogonal XYZ axes. The X-axis corresponds to the length direction of vascular lesion models 1 and 2 (vascular model 1 and lesion model 2), the Y-axis corresponds to the height direction of vascular lesion models 1 and 2, and the Z-axis corresponds to the width direction of vascular lesion models 1 and 2. Figure 2 The left side (in the -X-axis direction) is referred to as the "anterior side" of vascular lesion models 1 and 2. When using a antegrade approach, the anterior side is the side furthest from the insertion site of the medical device (distal side). Additionally, [the text abruptly ends here]. Figure 2 The right side (in the +X axis direction) is referred to as the "basal side" of vascular lesion models 1 and 2. In the case of antegrade approach, the basal side is the side closer to the insertion site of the medical device (proximal side). These points are located in... Figure 2 The same applies to the subsequent diagrams.

[0042] Figure 2 The upper part shows the longitudinal cross-sectional structure of vascular lesion models 1 and 2. Figure 2 The lower half (within the dashed dialog box) shows Figure 2 An enlarged view of the first lesion 32 in the upper part of lesion model 2. (See image below.) Figure 2 As shown in the upper part, the vascular model 1 has a vascular portion 10 with a tubular shape simulating the arteries of the human lower limb. The vascular portion 10 has openings 1a and 1b at both ends, and an inner lumen 1L for the flow of simulated blood (e.g., physiological saline). The vascular portion 10 can be formed of any material. For example, in addition to being formed of PVA, which has similar sliding and elastic properties to human blood vessels, the vascular portion 10 can also be formed of polysaccharides such as agarose, sodium alginate, cellulose, starch, and glycogen, and resins such as silicon, latex, and polyurethane. It should be noted that the inner diameter, outer diameter, and length in the X-axis direction of the vascular portion 10 can be arbitrarily determined.

[0043] Disease model 2 is a model simulating human disease, placed in the lumen 1L of the vascular portion 10. For example... Figure 2 As shown in the upper part, the lesion model 2 has three first lesion parts 31, 32, and 33, two second lesion parts 41 and 42, and a fixation part 20. Hereinafter, the first lesion parts 31, 32, and 33 and the second lesion parts 41 and 42 will be collectively referred to as "multiple lesion parts". The multiple lesion parts are arranged along the length direction (i.e., the X-axis direction) of the vascular model 1. Figure 2 In the example of the upper part, three first lesion parts 31, 32, and 33 and two second lesion parts 41 and 42 are alternately arranged along the length of the blood vessel model 1. Specifically, in Figure 2In the example in the upper part, the three first lesion parts 31, 32, and 33 and the two second lesion parts 41 and 42 are arranged alternately from the +X axis direction toward the -X axis direction in the order of first lesion part 31, second lesion part 41, first lesion part 32, second lesion part 42, and first lesion part 33.

[0044] Figure 3 This is an example. Figure 2 A diagram illustrating the cross-sectional structure at line AA. (Refer to...) Figure 3 and Figure 2 The lower half describes the structure of the first lesion portion 32. The first lesion portion 32 includes a main body portion 321 and a calcified portion 322. (As...) Figure 3 As shown, the main body 321 is a cylindrical component with 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 vascular model 1. Here, in this embodiment, "outer diameter" and "inner diameter" refer to the length of the longest part of any cross-section when the cross-section of the component (or lumen) is elliptical. The main body 321 is formed of a first polymer material. As the first polymer material, in addition to agarose, which has an elasticity similar to that of chronic total occlusion (CTO), gelatin, PVA, polyurethane, silicon, sodium alginate, cellulose, starch, glycogen, latex, etc., can also be used.

[0045] Multiple calcified portions 322 are embedded in the main body 321. For example... Figure 2 The lower half and Figure 3 As shown, the calcified portions 322 are granular with non-uniform shapes and sizes. That is, the calcified portions 322 can be any shape, such as spherical, polyhedral, cylindrical, or conical. The calcified portions 322 can also be as thin as a film. The lengths La, Lb, and Lc of the calcified portions 322 in the longitudinal direction can be the same or different. The calcified portions 322 can be formed from 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 from paraffin alone, or from a material obtained by adding stearic acid to paraffin. It should be noted that, in addition to containing the calcified portions 322, the main body 321 of the first lesion portion 32 can also contain microparticles or nanofibers that function as reflectors.

[0046] The structures of the first lesion portion 31 and the first lesion portion 33 are the same as those of the first lesion portion 32 described above. Here, in this embodiment, "same" and "identical" mean approximately equal, and do not mean that they are not strictly identical, but rather that differences caused by manufacturing errors, etc., are allowed.

[0047] like Figure 2As shown in the upper part, the second lesion portion 41 includes a main body portion 411 and a calcified portion 412. The main body portion 411, like the main body portion 321 of the first lesion portion 32, is a cylindrical component with an outer diameter smaller than the inner diameter Φ10 of the vascular model 1. It should be noted that the outer diameter of the main body portion 411 can be the same as or different from the outer diameter Φ32 of the main body portion 321. The main body portion 411 is formed of a second polymer material different from the first polymer material. As the second polymer material, in addition to agarose, which has an elasticity similar to CTO, gelatin, PVA, polyurethane, silicon, sodium alginate, cellulose, starch, glycogen, latex, etc., can also be used. It should be noted that "the first polymer material and the second polymer material are different" means, without a doubt, the use of different materials, and also means the case where the concentration of the same material is changed during gelation (i.e., it means that even if only the concentration is different, it is still considered a different material).

[0048] Multiple calcified portions 412 are embedded in the main body 411. Like the calcified portions 322, the calcified portions 412 are granular with uneven shape and size, and can have arbitrary shape, thickness, and length. Like the calcified portions 322, the calcified portions 412 can be formed from paraffin alone or from paraffin with added stearic acid. The material of the calcified portions 412 can be the same as or different from the material of the calcified portions 322. It should be noted that, in addition to the calcified portions 412, the main body 411 of the second lesion 41 may also contain microparticles or nanofibers that function as reflectors. The structure of the second lesion 42 is the same as that of the second lesion 41 described above.

[0049] In this embodiment, the first lesion portions 31, 32, and 33 are harder than the second lesion portions 41 and 42. Specifically, for example, when measuring the hardness of the first lesion portion 31 (the entire first lesion portion 31 including the calcified portion 312) and the second lesion portion 41 (the entire second lesion portion 41 including the calcified portion 412) using a known hardness measuring instrument, the hardness of the first lesion portion 31 is found to be greater than the hardness of the second lesion portion 41. In other words, by adjusting the aforementioned first polymer material, the material of the calcified portions 312, 322, and 332, or the density of the calcified portions 312, 322, and 332, the first lesion portions 31, 32, and 33 are configured to be harder than the second lesion portions 41 and 42.

[0050] exist Figure 2In the example in the upper part, the first lesion portions 31, 32, and 33 have the same length L31 in the longitudinal direction, but they can also have different lengths. Similarly, the second lesion portions 41 and 42 have the same length L41 in the longitudinal direction, but they can also have different lengths. Furthermore, lengths L31 and L41 can also be different. The three first lesion portions 31, 32, and 33 and the two second lesion portions 41 and 42 are configured in a mutually separated state.

[0051] The fixing part 20 is a component that fixes multiple lesion parts (i.e., first lesion parts 31, 32, 33 and second lesion parts 41, 42) to the lumen 1L of the vascular model 1. Figure 2 As shown in the upper part, the fixing part 20 includes a first fixing part 21, a second fixing part 22, and a third fixing part 23. It should be noted that the length L20 of the fixing part 20 in the longitudinal direction can be arbitrarily determined. It should also be noted that in this embodiment, the length L20 of the fixing part 20 in the longitudinal direction is synonymous with the length of the lesion model 2 in the longitudinal direction.

[0052] The first fixing part 21 is located closer to the proximal side (in the +X axis direction) than the first lesion part 31, and is the portion inside excluding the first lesion part 31. The proximal ends of multiple lesions (specifically, the basal ends of the first lesion part 31) are fixed to the inner circumferential surface 12 of the vascular model 1 via the first fixing part 21. In the illustrated example, the first fixing part 21 is provided throughout the entire circumference of the inner circumferential surface 12 of the vascular model 1. Furthermore, the first fixing part 21 has an outer surface 211 perpendicular to the axis O.

[0053] The second fixing part 22 is located closer to the distal side (in the -X-axis direction) than the first lesion part 33, and is the portion inside excluding the first lesion part 33. The distal ends of the plurality of lesions (specifically, the front end of the first lesion part 33) are fixed to the inner circumferential surface 12 of the vascular model 1 by means of the second fixing part 22. In the illustrated example, the second fixing part 22 is provided throughout the entire circumferential direction of the inner circumferential surface 12 of the vascular model 1. Furthermore, the second fixing part 22 has an outer surface 221 perpendicular to the axis O. Thus, by fixing with the first fixing part 21 and the second fixing part 22, the movement of the plurality of lesions (i.e., the first lesion parts 31, 32, 33 and the second lesion parts 41, 42) along the length direction of the vascular model 1 is restricted.

[0054] The third fixing part 23 is disposed between the first fixing part 21 and the second fixing part 22. It fills the gaps between the outer peripheral surfaces of the inner peripheral surfaces 12 of the multiple lesion parts (first lesion parts 31, 32, 33 and second lesion parts 41, 42) facing the blood vessel model 1 and adjacent lesion parts. Through the third fixing part 23, the outer peripheral surfaces of the multiple lesion parts facing the blood vessel model 1 (specifically, the outer peripheral surfaces of the first lesion parts 31, 32, 33 and the second lesion parts 41, 42) are fixed to the inner peripheral surface 12 of the blood vessel model 1. In this way, the movement of the multiple lesion parts (i.e., the first lesion parts 31, 32, 33 and the second lesion parts 41, 42) along the circumferential direction of the blood vessel model 1 is restricted by the fixing of the third fixing part 23.

[0055] The fixing part 20 is formed of a third polymer material, which is different from the first and second polymer materials. Besides agarose, which has an elasticity similar to CTO, other materials that can be used as the third polymer material include gelatin, PVA, polyurethane, silicon, sodium alginate, cellulose, starch, glycogen, and latex. It should be noted that "the third polymer material is different from the first and second polymer materials" undoubtedly means using different materials, and also implies a change in the concentration when using the same material for gelation (meaning that in this case, it is also considered a different material).

[0056] Figure 4 These are explanatory diagrams illustrating the manufacturing methods of vascular lesion models 1 and 2. Figures 1-3 The vascular lesion models 1 and 2 described herein can be made, for example, in the following order. Figure 4 (A) shows the preparation of the first lesion 31 and the second lesion 41.

[0057] First, such as Figure 4 As shown in (A), prepare any number of first lesion portions 31 to 3n (n is any natural number, hereinafter using n=3 as an example) and any number of second lesion portions 41 to 4m (m is any natural number, hereinafter using m=2 as an example). The first lesion portion 31 can be formed by pouring a gel-like first polymer material into a cylindrical mold frame, embedding any number of calcified portions 312 into the gel before the gel solidifies, allowing the gel to solidify and be demolded, thereby forming the first lesion portion 31. The second lesion portion 41 can be formed by pouring a gel-like second polymer material into a cylindrical mold frame, embedding any number of calcified portions 412 into the gel before the gel solidifies, allowing the gel to solidify and be demolded, thereby forming the second lesion portion 41.

[0058] Figure 4(B) shows the preparation of vascular model 1. Next, as... Figure 4 As shown in (B), a blood vessel model 1 with a tube shape is prepared from an arbitrary polymer material. Figure 4 (C) illustrates the configuration of the first lesion portions 31, 32, 33 and the second lesion portions 41, 42 in the vascular model 1. Figure 4 In the lumen 1L of the vascular model 1 prepared by (B), it is placed in Figure 4 The first lesion 31-33 and the second lesion 41-42 were prepared in (A). Figure 4 In example (C), from the opening 1a side toward the opening 1b side, the first lesion portions 31-33 and the second lesion portions 41-42 are alternately arranged and are arranged with a gap between them. Figure 4 (D) shows the formation of the fixing part 20. Next, as... Figure 4 As shown in (D), a gel-like third polymer material is poured in and allowed to solidify.

[0059] exist Figure 4 The example illustrates the case where the number of first lesions 31–3n is set to three (n=3), and the number of second lesions 41–4m is set to two (m=2). However, according to Figure 4 The method described allows for easy modification of the number of first lesion portions 31-3n and the number of second lesion portions 41-4m. As a result, the length L20 of the lesion model 2 along the length direction (X-axis direction) of the blood vessel model 1 can be easily modified. Figure 2 (the upper half). Therefore, by increasing the number of the first lesion portions 31 to 3n and the number of the second lesion portions 41 to 4m, it is possible to easily create a long lesion model 2 (i.e., a lesion model 2 simulating lesions occurring in the arteries of the human lower limb).

[0060] Figure 5This diagram illustrates a simulation of surgery performed using vascular lesion models 1 and 2. Using the vascular simulation device 100 equipped with the vascular lesion models 1 and 2 as described above, the surgeon can simulate surgery performed on the lesion model 2 using medical equipment. For example, the surgeon operates the circulation pump 9, circulates fluid (e.g., simulated blood such as saline) into the vascular model 1, cuts a portion of the vascular model 1, and inserts a through-wire guidewire 8 into the lumen 1L of the vascular model 1. Then, the surgeon transports the tip of the through-wire guidewire 8 to the location of the lesion model 2. For example, as shown, the surgeon approaches the lesion model 2 from the side of the first fixation part 21 in a forward direction. Then, by pushing the through-wire guidewire 8, the surgeon causes it to pass through the first fixation part 21, and then through the first lesion part 31, the second lesion part 42, etc., thereby simulating the surgery to open the lesion model 2. It should be noted that... Figure 5 The example illustrates the use of a penetrating guidewire 8 for puncture, but other methods (e.g., ablation using a plasma guidewire) can also be used to open the lesion model 2.

[0061] As described above, according to the first embodiment, the length L20 of the lesion model 2 of the vascular lesion models 1 and 2 can be easily adjusted by changing the number of first lesion portions 31-3n and second lesion portions 41-4m included in the plurality of lesions arranged along the length direction (X-axis direction) of the vascular lesion model 1. Figure 2 Furthermore, since the multiple lesion portions include first lesion portions 31-3n formed of a first polymer material and second lesion portions 41-4m formed of a second polymer material, the physical properties (mechanical, thermal, electrical, magnetic, and optical properties) of the first lesion portions 31-3n and the second lesion portions 41-4m can be easily adjusted by adjusting the first and second polymer materials. In addition, the two ends of the lesion model 2 in the length direction are fixed to the inner circumferential surface 12 of the blood vessel model 1, thereby restricting movement along the length direction of the lesion model 2. Therefore, as... Figure 5 As explained, when simulating surgery using vascular lesion models 1 and 2, even when the medical device 8 within the vascular model 1 is pushed towards the lesion model 2, movement of the lesion model 2 in the length direction due to the pushing can be suppressed. As a result, according to the structure of the first embodiment, vascular lesion models 1 and 2 that achieve a lesion model 2 that closely approximates the real clinical morphology can be provided.

[0062] Furthermore, 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 part 23, thereby further restricting the circumferential movement of the lesion model 2. Therefore, as Figure 5As explained, when simulating surgery using vascular lesion models 1 and 2, even when the medical device 8 within the vascular model 1 is rotated while being pushed towards the lesion model 2, the lesion model 2 can be prevented from moving circumferentially with the push. Furthermore, since the third fixing part 23 also fills the gap between adjacent lesions, the movement of the lesion model 2 in the length and circumferential directions can be further suppressed, and cracks are generated between the vascular model 1 and the fixing part 20 as the medical device 8 is pushed, thereby simulating real blood vessels and false lumens generated in lesions.

[0063] Furthermore, according to the first embodiment, the first fixing part 21 and the second fixing part 22 of the fixing part 20 can fix both ends of the lesion model 2 in the length direction to the inner peripheral surface 12 of the blood vessel model 1. In addition, since the first fixing part 21 and the second fixing part 22 are harder than the first lesion parts 31-3n and the second lesion parts 41-4m, the first fixing part 21 and the second fixing part 22 can simulate the compressed and hardened end tissue in human lesions (e.g., the mass of a plaque lesion or a calcified lesion).

[0064] Here, human lesions often exhibit uneven hardness and a patchy hardness distribution. In this respect, according to the vascular lesion models 1 and 2 of the first embodiment, since the first lesion portions 31-3n are harder than the second lesion portions 41-4m, a lesion model 2 that approximates human lesions with uneven hardness can be achieved. Furthermore, according to the vascular lesion models 1 and 2 of the first embodiment, since the lesion model 2 includes multiple first lesion portions 31-3n and multiple second lesion portions 41-4m, it is possible to simulate lesions arising from the arteries of the human lower limbs (lesions that are much longer than those arising from the coronary arteries of the heart). Moreover, since the multiple first lesion portions 31-3n and the multiple second lesion portions 41-4m are alternately arranged along the length direction of the vascular model 1, a lesion model 2 that approximates human lesions with a patchy hardness distribution along the length direction can be achieved.

[0065] Furthermore, according to the first embodiment, since the first lesion portions 31-3n and the second lesion portions 41-4m include calcified portions 312 and 412, it is possible to simulate lesions containing calcifications in human lesions. Thus, if both the first lesion portions 31-3n and the second lesion portions 41-4m are configured to include calcified portions 312 and 412, it is possible to simulate lesions containing calcifications uniformly along the length of the blood vessel model 1. Moreover, since the calcified portions 312 and 412 are granular and harder than both the first and second polymer materials, the structure of the calcified portions 312 and 412 can be approximated to the structure of calcified portions contained in human lesions.

[0066] <Second Implementation>

[0067] Figure 6 This is an explanatory diagram illustrating the cross-sectional structure of the vascular lesion models 1 and 2A according to the second embodiment. The vascular simulation device 100A of the second embodiment includes vascular lesion models 1 and 2A instead of vascular lesion models 1 and 2. In the structure described in the first embodiment, vascular lesion models 1 and 2A have lesion model 2A instead of lesion model 2. In the structure described in the first embodiment, lesion model 2A has a fixing part 20A instead of fixing part 20. The fixing part 20A is located closer to the proximal side (in the +X axis direction) than the first lesion part 31, and only has a first fixing part 21 for fixing the proximal ends (the basal end ends of the first lesion part 31) of multiple lesions to the inner peripheral 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.

[0068] Thus, the structure of the lesion model 2A can be modified in various ways, and it can be a structure that fixes only the end of any one of the multiple lesion parts (i.e., the first lesion parts 31, 32, 33 and the second lesion parts 41, 42). Figure 6 The example given is that the proximal ends of multiple lesions are fixed, but it is also possible to fix only the distal ends of multiple lesions (the end of the front end of the first lesion 33).

[0069] The vascular lesion models 1 and 2A of this second embodiment can also achieve the same effect as the first embodiment described above. Specifically, with Figure 5 Similarly, when the guidewire 8 is brought closer to the lesion model 2A from the first fixing part 21 side in a forward approach, the first fixing part 21 abuts against the guidewire 8, which can suppress the movement of the lesion model 2A in the length direction. Furthermore, when the guidewire 8 is brought closer to the lesion model 2A from the first lesion part 33 side in a reverse approach, the first fixing part 21 supports the multiple lesions pushed towards the +X axis by the guidewire 8, which can suppress the movement of the lesion model 2A in the length direction.

[0070] <Third Implementation Method>

[0071] Figure 7 These are explanatory diagrams illustrating the cross-sectional structures of vascular lesion models 1 and 2B according to the third embodiment. Figure 7 The upper part shows the longitudinal cross-sectional structure of vascular lesion models 1 and 2B. Figure 7The lower half (within the dashed dialog box) shows the cross-sectional structure at line BB of the vascular lesion models 1 and 2B. The vascular simulation device 100B of the third embodiment includes vascular lesion models 1 and 2B, replacing vascular lesion models 1 and 2. In the structure described in the first embodiment, vascular lesion models 1 and 2B have lesion model 2B instead of lesion model 2. In the structure described in the first embodiment, lesion model 2B has a fixing part 20B instead of fixing part 20.

[0072] The fixation part 20B includes a first fixation part 21B and a third fixation part 23B. The first fixation part 21B is located closer to the proximal side (+X-axis direction) than the first lesion part 31, and is the portion inside that does not include the first lesion part 31. Through the first fixation part 21B, the proximal ends of multiple lesions (specifically, the basal ends of the first lesion part 31) are fixed to the inner peripheral surface 12 of the vascular model 1. Figure 7 As shown in the upper part, the first fixing part 21B is provided in a circumferential portion of the inner circumferential surface 12 of the blood vessel model 1. Therefore, for the portion where the first fixing part 21B is provided, there is a portion 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 part 21B. In the vascular lesion models 1 and 2B of the third embodiment, fluid can flow through this gap SP. In addition, the outer surface 211B of the first fixing part 21B is not perpendicular to the axis O but inclined.

[0073] The third fixing part 23B is located closer to the distal side (in the -X-axis direction) than the first fixing part 21B. The third fixing part 23B fills a portion of the outer peripheral surface of the inner peripheral surface 12 of the vascular model 1, which is the surface of multiple lesions (first lesions 31, 32, 33 and second lesions 41, 42), and a portion of the gap between adjacent lesions. For example... Figure 7 As shown in the lower half, the third fixing part 23B is disposed on a portion of the circumferential surface 12 of the vascular model 1. Therefore, similarly, in the portion where the third fixing part 23B is provided, a gap SP exists between the inner circumferential surface 12 and multiple lesions and the third fixing part 23B on a portion of the circumferential surface of the vascular model 1. It should be noted that the extent of the inner circumferential surface 12 covered by the first fixing part 21B and the third fixing part 23B in the vascular model 1 can be arbitrarily determined.

[0074] Thus, the structure of the lesion model 2B can be modified in various ways, and the shape of the first fixing part 21B can be arbitrarily changed. Specifically, the first fixing part 21B may have an outer surface 211B that is inclined relative to the axis O, or it may not be provided in the entire circumferential direction of the inner peripheral surface 12 of the blood vessel model 1. This is also the case for the second fixing part 22 when it is provided in the lesion model 2B. In addition, the shape of the third fixing part 23B can be arbitrarily changed. Specifically, the third fixing part 23B may not be provided in the entire circumferential direction of the inner peripheral surface 12 of the blood vessel model 1. With the blood vessel lesion models 1 and 2B of this third embodiment, the same effect as the first embodiment described above can be achieved. In addition, according to the blood vessel lesion models 1 and 2B of the third embodiment, a lesion model 2B that simulates a stenotic lesion can be provided.

[0075] <Fourth Implementation>

[0076] Figure 8 This is an explanatory diagram illustrating the cross-sectional structure of the vascular lesion models 1 and 2C according to the fourth embodiment. The vascular simulation device 100C of the fourth embodiment includes vascular lesion models 1 and 2C, replacing vascular lesion models 1 and 2. In the structure described in the first embodiment, vascular lesion models 1 and 2C have lesion model 2C instead of lesion model 2. In the structure described in the first embodiment, lesion model 2C has three first lesion portions 31C, 32C, and 33C, and two second lesion portions 41C and 42C. These plurality of lesion portions are arranged from the +X-axis direction toward the -X-axis direction in the order of second lesion portion 41C, second lesion portion 42C, first lesion portion 31C, first lesion portion 32C, and first lesion portion 33C.

[0077] Thus, the structure of lesion model 2C can be modified in various ways, and the first lesion parts 31C, 32C, and 33C and the second lesion parts 41C and 42C can be configured without alternation. The illustrated example shows three first lesion parts 31C, 32C, and 33C, two second lesion parts 41C and 42C, and an example of their configuration. However, the number of first lesion parts n and the number of second lesion parts m can be arbitrarily changed. Furthermore, the configuration of n first lesion parts and m second lesion parts can also be arbitrarily changed.

[0078] The vascular lesion models 1 and 2C of this fourth embodiment can achieve the same effect as those of the first embodiment. Furthermore, as explained in the first embodiment, since "the hardness of the first lesion portion 31 is greater than the hardness of the second lesion portion 41", in the lesion model 2C of the fourth embodiment, by adjusting the number of first lesions n and second lesions m, and the arrangement of the n first lesions and the m second lesions, lesion models 2C with various hardness distributions can be created.

[0079] <Fifth Implementation>

[0080] Figure 9 This is an explanatory diagram illustrating the cross-sectional structure of the vascular lesion models 1 and 2D according to the fifth embodiment. The vascular simulation device 100D of the fifth embodiment includes vascular lesion models 1 and 2D, replacing vascular lesion models 1 and 2. In the structure described in the first embodiment, vascular lesion models 1 and 2D have lesion model 2D instead of lesion model 2. In the structure described in the first embodiment, lesion model 2D has a second lesion portion 41D instead of second lesion portion 41, and a second lesion portion 42D instead of second lesion portion 42. The second lesion portions 41D and 42D do not include calcified portions 412 and 422, and are composed only of main body portions 411 and 421.

[0081] Thus, the structure of the lesion model 2D can be modified in various ways, and it can also be a structure with second lesion parts 41D and 42D that do not include calcification. In the illustrated example, the second lesion parts 41D and 42D are shown without calcification, but it can also be a structure with first lesion parts 31, 32, and 33 that do not include calcification.

[0082] The vascular lesion models 1 and 2D of this fifth embodiment can achieve the same effect as the first embodiment described above. Here, the lesion portion without calcification is softer than the lesion portion including calcification. Therefore, according to the structure of the fifth embodiment, by mixing the second lesion portions 41D and 42D without calcification with the first lesion portions 31, 32, and 33 including calcification 312, 322, and 332, a lesion model 2D with a wider hardness distribution can be produced. In other words, as explained in the vascular lesion models 1 and 2D of the fifth embodiment, if the structure includes calcification in any one of the first lesion portions 31, 32, and 33 and the second lesion portions 41D and 42D, it is possible to simulate a lesion containing calcification in a patchy pattern along the length direction of the vascular model 1.

[0083] <Sixth Implementation Method>

[0084] Figure 10This is an explanatory diagram illustrating the cross-sectional structure of the vascular lesion models 1 and 2E according to the sixth embodiment. The vascular simulation device 100E of the sixth embodiment includes vascular lesion models 1 and 2E, replacing vascular lesion models 1 and 2. In the structure described in the fifth embodiment, vascular lesion models 1 and 2E have lesion model 2E instead of lesion model 2D. In the structure described in the fifth embodiment, lesion model 2E has a first lesion portion 31E instead of first lesion portion 31, a first lesion portion 32E instead of first lesion portion 32, and a first lesion portion 33E instead of first lesion portion 33. The first lesion portions 31E, 32E, and 33E do not include calcified portions 312, 322, and 332, and are only composed of main body portions 311, 321, and 331.

[0085] Thus, the structure of the lesion model 2E can be modified in various ways, and it can also be a structure in which neither the first lesion part 31E, 32E, 33E nor the second lesion part 41D, 42D includes calcification. Even in this case, since "the hardness of the first lesion part 31E is greater than the hardness of the second lesion part 41D", by adjusting the number of one lesion part n and the number of second lesion parts m in the lesion model 2E, as well as the configuration of the n first lesion parts and the m second lesion parts, it is possible to manufacture lesion models 2E with various hardness distributions.

[0086] The vascular lesion models 1 and 2E of this sixth embodiment can achieve the same effect as those of the first embodiment. Furthermore, in the lesion model 2E of the sixth embodiment, since the time and cost of fabricating the first lesion portions 31E, 32E, and 33E and the second lesion portions 41D and 42D can be reduced, the lesion model 2E can be fabricated more simply and at a lower cost.

[0087] <Seventh Implementation>

[0088] Figure 11 This is an explanatory diagram illustrating the cross-sectional structure of the second lesion portion 41F according to the seventh embodiment. The vascular simulation device 100F of the seventh embodiment includes vascular lesion models 1 and 2F, replacing vascular lesion models 1 and 2. In the structure described in the first embodiment, vascular lesion models 1 and 2F have lesion model 2F instead of lesion model 2. In the structure described in the first embodiment, lesion model 2F has a second lesion portion 41F instead of the second lesion portion 41. As... Figure 11As shown, the second lesion portion 41F does not have the calcified portion 412 described in the first embodiment, and instead contains a central portion 412F that is harder than the main body portion 411 within the main body portion 411. In the illustrated example, the central portion 412F is a flattened sphere, but it can also be any shape. The central portion 412F can be formed, for example, using the same material as the main body portion 411 by increasing the concentration during gelation, or it can be formed using a different material than the main body portion 411.

[0089] Thus, the structure of the second lesion portion 41F can be modified in various ways, and the structure of the calcified portion 412 can be replaced by a central portion 412F that is harder than the main body portion 411. The same applies to the second lesion portion 42 and the first lesion portions 31, 32, and 33. With this seventh embodiment of the vascular lesion model 1, 2F, the same effects as described in the first embodiment can be achieved.

[0090] <Eighth Embodiment>

[0091] Figure 12 This diagram shows a schematic structure of the vascular simulation device 100G according to the eighth embodiment. The vascular simulation device 100G of the eighth embodiment, in the structure described in the first embodiment, does not include the outer tissue model 3 and the circulation pump 9. The vascular lesion models 1 and 2 of the vascular simulation device 100G can be used after being moistened with fluid (e.g., physiological saline or simulated blood) or in a dry state. Furthermore, regarding the vascular simulation device 100G, for example, it has an internal water tank that can be filled with fluid, so the vascular lesion models 1 and 2 can also be used while placed in the water tank filled with fluid. With this vascular simulation device 100G of the eighth embodiment, the same effects as those of the first embodiment described above can be achieved.

[0092] <Modifications of this embodiment>

[0093] The present invention is not limited to the above embodiments, and can be implemented in various ways without departing from its spirit, for example, the following modifications are also possible.

[0094] [Variation Example 1]

[0095] In the first to eighth embodiments described above, an example of the structure of the vascular simulation devices 100, 100A to 100G was shown. However, the structure of the vascular simulation device 100 can be modified in various ways. For example, the vascular simulation device 100 may have organ models that mimic organs such as the heart, liver, brain, and lower limbs. In this case, the vascular lesion models 1 and 2 may be disposed on the outside or inside of the organ models. For example, the vascular simulation device 100 may also include a pulsating pump for applying simulated pulsating motion to the fluid circulated by the circulating pump 9. For example, the pulsating pump may be a positive displacement reciprocating pump or a low-speed rotary pump.

[0096] [Variation Example 2]

[0097] In the first to eighth embodiments described above, an example of the structure of the vascular lesion models 1, 2, 2A to 2F is shown. However, the structure of the vascular lesion models 1 and 2 can be modified in various ways. For example, the vascular model 1 can be any shape, such as a curved shape or a tortuous shape, in addition to being straight. For example, the outer peripheral surface 11 or the inner peripheral surface 12 of the vascular model 1 can also be coated with a hydrophilic or hydrophobic resin.

[0098] [Variation Example 3]

[0099] In the first to eighth embodiments described above, an example of the structure of the lesion models 2, 2A to 2F is shown. However, the structure of the lesion model 2 can be modified in various ways. For example, in the lesion model 2, adjacent first lesion portions 31 to 3n and second lesion portions 41 to 4m can be arranged without gaps and in contact with each other. For example, the first lesion portions 31 to 3n and the second lesion portions 41 to 4m can be different from each other in terms of factors other than hardness (e.g., shape, size). For example, at least one of the first lesion portions 31 to 3n and the second lesion portions 41 to 4m can be configured as a lesion portion that closes the lumen 1L of the blood vessel model 1 by making its outer diameter the same as the inner diameter Φ10 of the blood vessel model 1.

[0100] For example, the hardness of the first lesion portions 31-3n and the second lesion portions 41-4m can be the same. For example, the hardness of the fixing portion 20 can be the same as or softer than any one of the first lesion portions 31-3n and the second lesion portions 41-4m.

[0101] [Variation Example 4]

[0102] The structures of the vascular simulation devices 100, 100A-100G or vascular lesion models 1, 2, 2A-2F in the first to eighth embodiments, as well as the structures of the vascular simulation devices 100, 100A-100G or vascular lesion models 1, 2, 2A-2F in the above-described modifications 1 to 3, can also be appropriately combined. For example, the fixing part 20 described in any of the second and third embodiments can be combined with the first lesion part 31-3n and the second lesion part 41-4m described in any of the fourth to seventh embodiments to construct vascular lesion models 1 and 2. For example, in the vascular simulation device 100G of the eighth embodiment, the vascular lesion models 1 and 2 described in any of the first to seventh embodiments can be used.

[0103] The present application has been described above based on embodiments and variations, but the above-described embodiments are for the purpose of facilitating understanding of the present application and are not intended to limit the present application. The present application can be modified and improved without departing from its spirit and the scope of the claims, and equivalents can be included in the present application. Furthermore, if a technical feature is not explicitly stated in this specification as essential, it can be appropriately omitted.

[0104] Symbol Explanation

[0105] 1, 2... Vascular lesion models

[0106] 1…vascular model

[0107] 2. 2A~2F… lesion models

[0108] 3…Lateral tissue model

[0109] 8…Medical equipment (through-wire guidewire)

[0110] 9… Circulation pump

[0111] 10… Vascular section

[0112] 11…outer periphery

[0113] 12…inner circumferential surface

[0114] 20, 20A, 20B... Fixed parts

[0115] 21, 21B... First fixed part

[0116] 22…Second fixed part

[0117] 23, 23B…Third Fixing Part

[0118] 31, 31C, 31E… First lesion

[0119] 32, 32C, 32E… First lesion

[0120] 33, 33C, 33E… First lesion

[0121] 41, 41C, 41D, 41F… Second lesion

[0122] 42, 42C, 42D… Second lesion

[0123] 100, 100A~100G… Vascular Simulation Device

[0124] 211, 211B... outer surface

[0125] 221…outer side

[0126] 311, 321… Main body

[0127] 312, 322… Calcifications

[0128] 411…Main Body

[0129] 412…Calcification

[0130] 412F…Central Section

Claims

1. A vascular lesion model, comprising: A tubular model of a blood vessel; and A lesion model, wherein the lesion model is disposed within the lumen of the vascular model. The lesion model has the following characteristics: A plurality of lesion portions are arranged along the length of the vascular model, the plurality of lesion portions comprising: a first lesion portion formed of a first polymeric material, and a second lesion portion formed of a second polymeric material different from the first polymeric material; and The fixing part restricts the movement of the lesion model along the length direction by fixing at least one end in the length direction to the inner peripheral surface of the blood vessel model. The fixing part is formed of a third polymer material and simulates the compressed and hardened end tissue in a human lesion in a manner that is harder than both the first lesion part and the second lesion part.

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

3. The vascular lesion model according to claim 1, wherein, In the lesion model, a plurality of first lesion portions and a plurality of second lesion portions are alternately arranged along the length of the blood vessel model.

4. The vascular lesion model according to claim 1, wherein, At least one of the first lesion and the second lesion includes granular calcifications, which are harder than both the first polymer material and the second polymer material.

5. The vascular lesion model according to claim 1, wherein, The lesion model further restricts the circumferential movement of the lesion model by fixing the outer peripheral surface facing the blood vessel model to the inner peripheral surface of the blood vessel model.

Images