Testing methods for vascular models and catheters, and training methods for catheters.

Abstract

This invention provides a vascular model capable of simulating various pathological conditions in the coronary arteries, as well as a catheter testing method and catheter training method using this model. [Solution] A vascular model that simulates a coronary artery, comprising an inlet portion 22 formed on the main body that simulates the aorta, and a passage portion 30 extending from the inlet portion 22 that simulates the coronary artery, wherein a part of the passage portion 30 is formed on a replaceable portion 23 that can be attached to and detached from the main body. The replaceable portion 23 may have a convex lesion simulation portion 40 on the inner surface of the passage portion 30, or it may have a stenosis simulation portion 41 in which the inner diameter of the passage portion 30 is smaller than the inner diameter of the inlet portion 22.

Description

Technical Field

[0001] The present invention relates to a blood vessel model simulating a blood vessel, a test method for a catheter using the same, and a training method for a catheter.

Background Art

[0002] In recent years, an intervention has been performed in which a long medical instrument such as a catheter or a guide wire is inserted from the skin into a blood vessel and reaches a target position through the blood vessel to perform a procedure. Since the intervention is performed through a complexly bent blood vessel, the catheter is required to be able to reach the target position.

[0003] In percutaneous transluminal coronary angioplasty (PTCA), which is the treatment of coronary arteries, a thin catheter is inserted toward the peripheral side of the coronary artery, and treatment for the lesion is performed. The coronary artery branches from the aorta into the left circumflex artery, the left anterior descending artery, and the right coronary artery, and a stenotic lesion may occur in each of them. In order for an operator to be able to appropriately insert a catheter into these, a training blood vessel model is used. For example, Patent Document 1 discloses a training blood vessel model simulating a coronary artery. The blood vessel model is also used to test the operating performance of a catheter and the like.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] Coronary artery pathologies, that is, the location and extent of lesions in the coronary arteries, vary greatly. For operator training or catheter testing, a vascular model that can represent various coronary artery pathologies is desirable. However, conventional vascular models only simulate stenosis at coronary artery bifurcations or in parts of the arteries, and do not represent a wide range of pathologies. In particular, a vascular model that can represent coronary artery stenosis due to calcification and chronic total occlusion (CTO) lesions is desired.

[0006] This invention was made to solve the above-mentioned problems and aims to provide a vascular model that can simulate various pathological conditions in the coronary arteries, a catheter testing method using the same, and a catheter training method. [Means for solving the problem]

[0007] The (1) vascular model according to the present invention, which achieves the above objective, is a vascular model that simulates a coronary artery, and has an inlet formed on the main body that simulates an aorta, and a passage extending from the inlet that simulates a coronary artery, wherein a part of the passage is formed as a replaceable part that can be attached to and removed from the main body.

[0008] A catheter testing method according to the present invention that achieves the above objective is a catheter testing method using a vascular model that simulates a coronary artery, wherein the vascular model has an inlet formed on the main body that simulates the aorta, and a passage extending from the inlet that simulates a coronary artery, and a part of the passage is formed in a replaceable part that can be attached to and removed from the main body, and the method comprises the steps of preparing a plurality of replaceable parts, each having a passage that simulates a lesion with a different pathological condition, selecting one of the plurality of replaceable parts and attaching it to the main body, and inserting a catheter from the inlet into the passage and testing the catheter.

[0009] A catheter training method according to the present invention that achieves the above objective is a catheter training method using a vascular model that simulates a coronary artery, wherein the vascular model has an inlet formed on the main body that simulates the aorta, and a passage extending from the inlet that simulates a coronary artery, and a part of the passage is formed on a replaceable part that can be attached to and removed from the main body, and the method comprises the steps of preparing a plurality of replaceable parts, each having a passage that simulates a lesion with a different pathological condition, selecting one of the plurality of replaceable parts and attaching it to the main body, and inserting a catheter from the inlet to the passage and performing catheter operation training. [Effects of the Invention]

[0010] The vascular model (1) configured as described above can be used for catheter testing and training by simulating various pathological conditions in the coronary arteries by providing parts that simulate lesions of different pathological conditions in multiple exchangeable sections.

[0011] (2) In the vascular model of (1) above, the replacement part may have a convex lesion simulation part on the inner surface of the passage part. This allows the vascular model to simulate calcified lesions in the coronary arteries and be used for catheter testing and training.

[0012] (3) In the vascular model of (1) or (2) above, the replacement portion may have a stenosis simulation portion in which the inner diameter of the passage portion is smaller than the inner diameter of the inlet portion. This allows the vascular model to be used for catheter testing and training by simulating chronic total occlusion lesions in the coronary arteries.

[0013] The catheter testing method (4) configured as described above allows for the selection of the replacement site and the testing of the catheter, thus enabling efficient testing of the catheter for various pathological conditions in the coronary arteries.

[0014] The catheter training method (5) configured as described above allows for training on various coronary artery conditions by selecting the exchange site. Furthermore, it is possible to prepare multiple exchange sites with different difficulty levels for catheter insertion, allowing for training tailored to the operator's skill level. [Brief explanation of the drawing]

[0015] [Figure 1] This is a plan view showing a vascular model simulating the left coronary artery according to this embodiment. [Figure 2] This is a plan view showing a vascular model simulating the right coronary artery according to this embodiment. [Figure 3] This diagram shows the left-rotating branch replacement section, where (a) is a plan view and (b) is a cross-sectional view of the passage section in section AA of (a). [Figure 4] (a) is a plan view showing the second left-rotating branch exchange section, and (b) is a plan view showing the third left-rotating branch exchange section. [Figure 5] This is a plan view showing the replacement section for the left front descending branch. [Figure 6] (a) is a plan view showing the left front descending branch exchange section, (b) is a plan view showing the left front descending branch second exchange section, and (c) is a plan view showing the left front descending branch third exchange section. [Figure 7] This diagram shows the replacement section on the inlet side of the right coronary artery, where (a) is a plan view and (b) is a cross-sectional view of the passage section when the passage section in (a) is straight. [Figure 8] This diagram shows the second replacement section on the inlet side of the right coronary artery, where (a) is a plan view and (b) is a cross-sectional view of the passage section when the passage section in (a) is straight. [Figure 9] This diagram shows the peripheral exchange portion of the right coronary artery, where (a) is a plan view and (b) is a cross-sectional view of the passage portion when the passage portion in (a) is straight. [Modes for carrying out the invention]

[0016] Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that the dimensions in the drawings may be exaggerated for convenience of explanation and may differ from the actual dimensions. Also, in this specification and the drawings, components having substantially the same function are denoted by the same reference numerals, and redundant descriptions are omitted.

[0017] The blood vessel model according to this embodiment simulates a coronary artery having a lesion, and can test the permeability at the lesion such as a microcatheter, and can be used for an operator to train a technique using a microcatheter or the like.

[0018] As the blood vessel model, a left coronary artery blood vessel model 10 simulating the left coronary artery and a right coronary artery blood vessel model 50 simulating the right coronary artery are prepared. As shown in FIG. 1, the left coronary artery blood vessel model 10 is configured such that an inlet portion 22 having a shape simulating the aorta is formed in a main body 20 having a frame-shaped outer frame portion 21, and a passage portion 30 extending from the inlet portion 22 and simulating the left coronary artery is provided. The inlet portion 22 and the passage portion 30 are each formed in a hollow tubular shape, and a medical long body such as a guide wire or a catheter can be inserted.

[0019] The left circumflex branch exchange portion 23, the left anterior descending branch exchange portion 24, and the left anterior descending branch bifurcation exchange portion 25 can be attached to and detached from the left coronary artery blood vessel model 10. The left circumflex branch exchange portion 23, the left anterior descending branch exchange portion 24, and the left anterior descending branch bifurcation exchange portion 25 each have a portion that becomes a part of the passage portion 30.

[0020] As shown in FIG. 2, the right coronary artery blood vessel model 50 is configured such that an inlet portion 62 having a shape simulating the aorta is formed in a main body 60 having a frame-shaped outer frame portion 61, and a passage portion 70 extending from the inlet portion 62 and simulating the right coronary artery is provided. The inlet portion 62 and the passage portion 70 are each formed in a hollow shape, and a medical long body such as a guide wire or a catheter can be inserted.

[0021] The right coronary artery model 50 has a right coronary artery inlet replacement section 63 and a right coronary artery peripheral replacement section 64 that can be attached and detached. The right coronary artery inlet replacement section 63 and the right coronary artery peripheral replacement section 64 each have a portion that becomes part of the passage section 70.

[0022] The main bodies 20 and 60 can be formed from a photocurable resin, specifically acrylic resin, that can be molded using a 3D printer. The main bodies 20 and 60 may also be formed from resin materials other than acrylic resin, such as silicone resin or various elastomer resins. Each of the interchangeable parts 23, 24, 25, 63, and 64 can be made from acrylic resin, silicone resin, or various elastomer resins, depending on the characteristics of the part being simulated, and a translucent or transparent resin is preferred.

[0023] Each replacement section is positioned in the part of the passage sections 30 and 70 that simulates the lesion. In the left coronary artery model 10, passage section 30 branches at bifurcation section 33 from the left main trunk simulated passage 31, which communicates with the inlet section 22, into the left circumflex branch simulated passage 32 and the left anterior descending branch simulated passage 34. As shown in Figure 1, the left circumflex branch replacement section 23 is positioned at the point where the left main trunk simulated passage 31 branches at bifurcation section 33 into the left circumflex branch simulated passage 32 and the left anterior descending branch simulated passage 34.

[0024] As shown in Figure 3(a), the left circumflex branch replacement section 23 has a left main trunk simulated passage 31 and left circumflex branch simulated passages 32 and left anterior descending branch simulated passages 34 that branch off at the bifurcation section 33. Multiple convex lesion simulation sections 40 are formed along the length of the inner surface of the left circumflex branch simulated passage 32. As shown in Figure 3(b), the lesion simulation sections 40 of the left circumflex branch replacement section 23 have a shape in which a part of a sphere or ellipsoid protrudes toward the left circumflex branch simulated passage 32. In addition, the lesion simulation sections 40 of the left circumflex branch replacement section 23 protrude from four directions in the circumferential direction of the left circumflex branch simulated passage 32. The left circumflex branch replacement section 23 is made of acrylic resin in order to simulate calcified lesions in the left circumflex branch using the lesion simulation sections 40.

[0025] In the left circumflex artery replacement section 23, the inner diameter of the left circumflex artery simulated passage 32 is 2 mm to 4 mm, and the protruding height of the lesion simulated section 40 is 0.8 mm to 1.8 mm. Furthermore, the length of the area in the left circumflex artery simulated passage 32 where the lesion simulated section 40 is provided is 20 mm to 50 mm.

[0026] The main body 20 of the left coronary artery model 10 can be selectively fitted with one of the following: a left circumflex branch replacement section 23, a left circumflex branch second replacement section 26, and a left circumflex branch third replacement section 27, each with a different shape simulating a lesion. As shown in Figure 4(a), the left circumflex branch second replacement section 26 has a stenosis simulation section 41 formed in the left circumflex branch simulated passage 32, which branches off from the left main trunk simulated passage 31 at the branch section 42, with a smaller inner diameter than the left main trunk simulated passage 31. In the left circumflex branch second replacement section 26, the stenosis simulation section 41 extends directly from the left main trunk simulated passage 31 at the branch section 42, making catheter insertion difficult. As shown in Figure 4(b), the left circumflex branch third exchange section 27 has a stenosis simulation section 43 formed in the left circumflex branch simulated passage 32, which branches off from the left main trunk simulated passage 31 at the branch section 44, and has a smaller inner diameter than the left main trunk simulated passage 31. In the left circumflex branch third exchange section 27, the stenosis simulation section 43 extends from the tip of the branch section 44, which gradually decreases in diameter from the left main trunk simulated passage 31. For this reason, it is easier to insert a catheter into the stenosis simulation section 43 of the left circumflex branch third exchange section 27 than into the stenosis simulation section 41 of the left circumflex branch second exchange section 26.

[0027] In the left-rotating branch second exchange section 26 and the left-rotating branch third exchange section 27, the inner diameter of the left main trunk simulated passage 31 is 2 mm to 4 mm, while the narrowed simulated sections 41 and 43, which have smaller inner diameters, have an inner diameter of 0.2 mm to 0.5 mm. In addition, the narrowed simulated sections 41 and 43 have a length of 10 mm or more, for example, 20 mm.

[0028] The second replacement section 26 and the third replacement section 27 of the left circumflex branch are formed from silicone resin to simulate a chronic total occlusion lesion that is softer than a calcified lesion.

[0029] The left anterior descending artery simulated passage 34 includes a left anterior descending artery exchange section 24 and a left anterior descending artery branching exchange section 25. The left anterior descending artery exchange section 24 has a tortuosic section 45, as shown in Figure 5. As shown in Figure 6(a), the left anterior descending artery branching exchange section 25 has a narrow section 47 branching off from the left anterior descending artery simulated passage 34 at a narrow branching section 46. The narrow section 47 simulates a peripheral blood vessel that further branches off from the coronary artery. In the left anterior descending artery branching exchange section 25, the narrow section 47 branches off from the left anterior descending artery simulated passage 34 at an angle of 120 degrees. The left anterior descending artery branching exchange section 25 is made of soft silicone resin.

[0030] The main body 20 of the left coronary artery model 10 can be selectively fitted with one of the following: a left anterior descending branch exchange section 25, a left anterior descending branch second exchange section 28, and a left anterior descending branch third exchange section 29, each having a different angle of the narrow section. As shown in Figure 6(b), in the left anterior descending branch second exchange section 28, the narrow section 47 that branches off from the left anterior descending simulated passage 34 via the narrow branch section 46 has an angle of 90 degrees with respect to the left anterior descending simulated passage 34. As shown in Figure 6(c), in the left anterior descending branch third exchange section 29, the narrow section 47 that branches off from the left anterior descending simulated passage 34 via the narrow branch section 46 has an angle of 60 degrees with respect to the left anterior descending simulated passage 34.

[0031] In the left front descending branch branching exchange section 25, the left front descending branch branching second exchange section 28, and the left front descending branch branching third exchange section 29, the inner diameter of the left front descending branch simulated passage 34 is 2 mm to 4 mm, and the narrower diameter section 47, which has a smaller inner diameter, has an inner diameter of 0.2 mm to 0.5 mm.

[0032] The right coronary artery inlet side replacement section 63, which is attached to the main body 60 of the right coronary artery model 50, is positioned in the curved portion of the passage section 70. As shown in Figure 7(a), the passage section 70 of the right coronary artery inlet side replacement section 63 has multiple convex lesion simulation sections 80 formed along its length on its inner surface. The lesion simulation sections 80 of the right coronary artery inlet side replacement section 63 have a shape in which a part of a sphere or ellipsoid protrudes toward the passage section 70. Also, as shown in Figure 7(b), the lesion simulation sections 80 of the right coronary artery inlet side replacement section 63 protrude from four directions in the circumferential direction of the passage section 70. The right coronary artery inlet side replacement section 63 is made of acrylic resin in order to simulate calcified lesions in the right coronary artery using the lesion simulation sections 80.

[0033] In the right coronary artery inlet replacement section 63, the inner diameter of the passage section 70 is 2 mm to 5 mm, and the protruding height of the lesion simulation section 80 is 0.8 mm to 2.3 mm. Furthermore, the length of the area in the passage section 70 where the lesion simulation section 80 is provided is 20 mm to 50 mm.

[0034] The main body 60 of the right coronary artery vascular model 50 can be selectively fitted with either a right coronary artery inlet replacement section 63 or a right coronary artery inlet second replacement section 65, each with a different shape simulating a lesion. As shown in Figure 8(a), the right coronary artery inlet second replacement section 65 has multiple convex lesion simulation sections 81 formed along its length on its inner surface. The lesion simulation sections 81 of the right coronary artery inlet second replacement section 65 rise from the inner surface of the passage section 70 so that their edges are straight. As shown in Figure 8(b), the lesion simulation sections 81 of the right coronary artery inlet second replacement section 65 protrude from two opposing directions in the circumferential direction of the passage section 70. The protrusion height of the lesion simulation sections 81 is 0.8 mm to 2.3 mm.

[0035] The right coronary artery distal replacement section 64, which is attached to the main body 60 of the right coronary artery vascular model 50, is located distal to the right coronary artery inlet replacement section 63 and is positioned in the curved portion of the passage section 70. As shown in Figure 9(a), the passage section 70 of the right coronary artery distal replacement section 64 has multiple convex lesion simulation sections 82 formed along its length on its inner surface. The lesion simulation sections 82 of the right coronary artery distal replacement section 64 rise from the inner surface of the passage section 70 so that their edges are straight. As shown in Figure 9(b), the lesion simulation sections 82 of the right coronary artery distal replacement section 64 protrude from four directions in the circumferential direction of the passage section 70. The protruding height of the lesion simulation sections 81 is 0.8 mm to 50 mm.

[0036] A method for testing a catheter using the vascular model of this embodiment will now be described. The tester prepares the catheter to be used for the test and the vascular model into which the catheter will be inserted for testing. Either the left coronary artery model 10 or the right coronary artery model 50 is selected as the vascular model. The tester also prepares interchangeable parts to be attached to the vascular model. As mentioned above, if multiple interchangeable parts simulating lesions with different pathological conditions are available, the tester selects one of the interchangeable parts and attaches it to the main body.

[0037] Once the vascular model is ready, the tester inserts the catheter into the passage from the entrance and performs the catheter test. The catheter is evaluated for its selectivity of pathways at bifurcations, its ability to pass through simulated lesions, and its ability to pass through simulated stenosis. The vascular model has interchangeable parts that can be attached and detached at multiple points in the passage, and one of several interchangeable parts simulating lesions of different pathological conditions can be selected and attached to the main body. This allows for the simulation of lesions of various pathological conditions in different parts of the coronary artery and enables catheter testing.

[0038] Catheter training can also be performed using steps similar to those used for catheter testing. Specifically, the catheter training method involves the operator selecting a vascular model, preparing multiple interchangeable parts, selecting one of these parts to attach to the main unit, inserting the catheter into the passage from the entrance, and performing catheter manipulation training. The vascular model allows for the attachment and detachment of interchangeable parts at multiple points in the passage, and allows the operator to select one of several interchangeable parts simulating lesions of different pathological conditions to attach to the main unit. This enables catheter training by simulating lesions of various pathological conditions in different parts of the coronary arteries. Furthermore, since multiple interchangeable parts with varying levels of difficulty in catheter insertion can be provided, training can be tailored to the operator's skill level.

[0039] As described above, the (1) vascular model according to this embodiment is a vascular model that simulates a coronary artery, and has an inlet portion 22 formed in the main body that simulates the aorta, and a passage portion 30 extending from the inlet portion 22 that simulates the coronary artery, with a part of the passage portion 30 being formed as a replaceable portion 23 that can be attached to and detached from the main body. The vascular model configured in this way can be used for catheter testing and training by simulating various pathological conditions in the coronary artery by providing parts that simulate lesions of different pathological conditions in multiple replaceable portions 23.

[0040] (2) In the vascular model described in (1) above, the replacement part 23 may have a convex lesion simulation part 40 on the inner surface of the passage part 30. This allows the vascular model to simulate calcified lesions in the coronary arteries and be used for catheter testing and training.

[0041] (3) In the vascular model described in (1) or (2) above, the replacement section 26 may have a stenosis simulation section 41 in which the inner diameter of the passage section 30 is smaller than the inner diameter of the inlet section 22. This allows the vascular model to be used for catheter testing and training by simulating chronic total occlusion lesions in the coronary arteries.

[0042] The (4) catheter testing method according to this embodiment is a catheter testing method using a vascular model that simulates a coronary artery, wherein the vascular model has an inlet 22 formed on the main body 20 that simulates the aorta, and a passage 30 extending from the inlet 22 that simulates a coronary artery, and a part of the passage 30 is formed on a replaceable part 23 that can be attached to and removed from the main body, and the method comprises the steps of preparing a plurality of replaceable parts 23, 26, and 27, each having a passage 30 that simulates a lesion with a different pathological condition, selecting one of the plurality of replaceable parts 23, 26, and 27 and attaching it to the main body 20, and inserting the catheter from the inlet 22 into the passage 30 and testing the catheter. With the catheter testing method configured in this way, the catheter can be tested by selecting the replaceable parts 23, 26, and 27, so the catheter can be efficiently tested for various pathological conditions in the coronary artery.

[0043] The (5) catheter training method according to this embodiment is a catheter training method using a vascular model that simulates a coronary artery, wherein the vascular model has an inlet 22 formed on the main body 20 that simulates the aorta, and a passage 30 extending from the inlet 22 that simulates a coronary artery, and a part of the passage 30 is formed on a replaceable part 23 that can be attached to and removed from the main body, and the method includes the steps of preparing a plurality of replaceable parts 23, 26, and 27, each having a passage 30 that simulates a lesion with a different pathological condition, selecting one of the plurality of replaceable parts 23, 26, and 27 and attaching it to the main body, and inserting the catheter from the inlet 22 into the passage 30 and performing catheter manipulation training. With the catheter training method configured in this way, catheter training can be performed by selecting the replaceable parts 23, 26, and 27, so training can be performed efficiently for various pathological conditions in the coronary artery, and a plurality of replaceable parts 23, 26, and 27 with different difficulty levels for catheter insertion can be prepared, so training can be performed according to the operator's skill level.

[0044] It should be noted that the present invention is not limited to the embodiments described above, and various modifications can be made by those skilled in the art within the technical framework of the present invention. The number and types of replaceable parts are not limited to the embodiments described above, and the shape of the lesion or stenosis formed in the passage can also be arbitrarily set. [Explanation of Symbols]

[0045] 10. Left coronary artery vascular model 20 Main unit 21 Outer frame 22 Entrance 23 Left circumflex branch exchange 24 Left anterior descending artery exchange part 25 Left front descending branch replacement section 26. Left-handed branch junction, second replacement section 27. Third replacement section of the left-rotating branch. 28 Left front descending branch, second exchange section 29 Left front descending branch, third exchange section 30 Passage section 31 Left main trunk mock passageway 32 Left circumflex branch simulation passage 33 Branching point 34 Left anterior descending branch simulated passage 40. Simulated lesion area 41 Stenosis simulation area 42 Branching point 43 Stenosis simulation area 44 Branching point 45. Meandering section 46. ​​Small diameter branch section 47 Thin section 50 Right coronary artery vascular model 60 Main Unit 61 Outer frame 62 Entrance 63 Right coronary artery ostial replacement site 64 Peripheral exchange portion of the right coronary artery 65 Right coronary artery ostial second exchange site 70 Passage section 80. Simulated lesion area 82. Simulated lesion 84. Simulated lesion area

Claims

1. A vascular model that simulates the coronary arteries, It has an inlet formed in the main body that simulates the aorta, and a passage extending from the inlet that simulates the coronary artery, A blood vessel model in which a portion of the passage is formed into a replaceable part that can be attached to and detached from the main body.

2. The vascular model according to claim 1, wherein the replacement part has a convex lesion simulation part on the inner surface of the passage part.

3. The vascular model according to claim 1, wherein the replacement part has a stenosis simulation part in which the inner diameter of the passage part is smaller than the inner diameter of the inlet part.

4. A method for testing catheters using a vascular model that simulates coronary arteries, The aforementioned vascular model has an inlet formed in the main body that simulates the aorta, and a passage extending from the inlet that simulates the coronary artery, and a part of the passage is formed as a replaceable part that can be attached to and detached from the main body. The steps include: preparing a plurality of replacement parts, each having a passage that simulates a lesion with a different pathological condition; The steps include selecting one of the multiple replacement parts and attaching it to the main body, A method for testing a catheter, comprising the steps of inserting the catheter into the passage from the entrance and testing the catheter.

5. A catheter training method using a vascular model that simulates the coronary arteries, The aforementioned vascular model has an inlet formed in the main body that simulates the aorta, and a passage extending from the inlet that simulates the coronary artery, and a part of the passage is formed as a replaceable part that can be attached to and detached from the main body. The steps include: preparing a plurality of replacement parts, each having a passage that simulates a lesion with a different pathological condition; The steps include selecting one of the multiple replacement parts and attaching it to the main body, A catheter training method comprising the steps of inserting the catheter into the passage from the entrance and performing catheter manipulation training.

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