Durability test device

Abstract

To provide a durability test device and a durability test method of a medical sheet material which can be conducted easily in a short period of time.SOLUTION: A durability test device 1 of a medical sheet material includes: a first holding member 10 having a center axial line C and configured to hold at least one medical sheet material 6 so as to project radially outward with respect to the center axial line; and a second holding member 20 surrounding the first holding member and having a center axial line common with the first holding member, and configured to hold at least one medical sheet material 6 so as to project radially inward with respect to the center axial line. The first holding member or the second holding member is configured to be rotatable about the center axial line. The rotation of the first holding member or the second holding member brings a first face 6a of the at least one medical sheet member held by the first holding member into abutment with a second face 6b of the at least one medical sheet material held by the second holding member.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a durability testing device, and more particularly to a durability testing device and a durability testing method for medical sheet materials. [Background technology]

[0002] In recent years, the number of cases of valvular heart disease treated in cardiovascular surgery has been increasing due to the aging population. Valvular heart disease is a condition in which the valves no longer function properly. Valvular heart disease is primarily classified into two types: stenosis, in which valve opening is restricted by hardened valve leaflets, obstructing blood flow, and insufficient valve closure due to weakened or uneven valve leaflets, resulting in backflow of blood. In particular, with the aging population, there has been an increase in cases of aortic valve stenosis, caused by arteriosclerosis (thickening or calcification) of the valve leaflets, and mitral valve regurgitation, caused by weakened valve tissue. Treatment for valvular heart disease initially involves conservative medication. However, conservative treatment does not address the valve itself. When valvular heart disease progresses, treatment of the valve itself, specifically surgical or catheter-based intervention, becomes necessary. Surgical treatment for aortic valve stenosis involves removal of the diseased valve and replacement with a prosthetic heart valve. Conventional artificial heart valves are divided into mechanical valves and biological valves. Mechanical valves have the problem of side effects from lifelong anticoagulant medication. Biological valves have the problem of requiring replacement through reoperation, as their durability is only about 10 years. Therefore, both mechanical and biological valves have their own issues, and the development of new materials is being considered.

[0003] Prosthetic heart valves must meet the requirements specified in ISO 5840. In particular, a durability testing device disclosed in Patent Document 1 is known for testing and evaluating the durability of biological valves such as prosthetic heart valves. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Publication No. 3-275054 Summary of the Invention [Problem to be solved by the invention]

[0005] Meanwhile, durability test devices for artificial valves that simulate the in vivo environment are commercially available (e.g., the Vivitro Labs Hicycle Durability Tester and the BDC Laboratories VDT-3600i). However, commercially available durability test devices have difficulty opening and closing artificial valves at high speeds due to the inertial forces that act when the artificial valve opens and closes, and completing the required cycle test takes a long time. Furthermore, attaching artificial valves to the durability test device is not easy, and it takes time to complete the attachment of all artificial valves. Because it takes a long time to complete a series of durability tests, it is difficult to conduct screening in a short period of time in the early stages of research on medical sheet materials. Furthermore, pressure adjustment and tuning of the durability test device are required during actual testing, requiring a certain level of technical skill on the part of the user. Furthermore, no durability test devices are known that can be used for medical sheet materials other than artificial valves such as cardiac valves, such as medical patches.

[0006] An object of the present invention is to provide a durability testing device and a durability testing method for medical sheet materials that can be carried out simply and in a short time. [Means for solving the problem]

[0007] According to one aspect of the present invention, there is provided a durability testing device for medical sheet materials, comprising: a first holding member having a central axis and configured to hold at least one of the medical sheet materials so as to protrude radially outward relative to the central axis; and a second holding member surrounding the first holding member and having a common central axis with the first holding member and configured to hold at least one of the medical sheet materials so as to protrude radially inward relative to the central axis, wherein the first holding member or the second holding member is configured to be rotatable about the central axis, and wherein a first side of the at least one medical sheet material held by the first holding member and a second side of the at least one medical sheet material held by the second holding member are configured to collide with each other in response to the rotation of the first holding member or the second holding member.

[0008] It is preferable that the medical sheet material further comprises a plurality of attachment members configured to be detachably attached to the first holding member and the second holding member, and each of the medical sheet materials is attached to the first holding member or the second holding member via the attachment members.

[0009] It is preferable that the apparatus further comprises a rotation drive mechanism capable of rotating the first holding member or the second holding member.

[0010] It is preferable that the device further comprises a container capable of holding a liquid so that the at least one medical sheet material held by the first holding member and the second holding member is immersed in the liquid.

[0011] It is preferable that the medical device further comprises a cover member that can be placed in the liquid or on the liquid surface so as to cover the at least one medical sheet material held by the first holding member and the second holding member.

[0012] The cover member is preferably a mesh member.

[0013] It is preferable that the medical sheet further comprises a reinforcing sheet placed on at least one of the backside of the first side of the at least one medical sheet material held by the first holding member or the backside of the second side of the at least one medical sheet material held by the second holding member.

[0014] The medical sheet material is preferably a valve leaflet material for an artificial valve.

[0015] According to another aspect of the present invention, there is provided a durability testing method for medical sheet materials, comprising the steps of: holding at least one medical sheet material relative to a first holding member having a central axis so that the medical sheet material protrudes radially outward relative to the central axis; holding at least one medical sheet material relative to a second holding member surrounding the first holding member and having a common central axis with the first holding member so that the medical sheet material protrudes radially inward relative to the central axis; immersing the at least one medical sheet material held by the first holding member and the second holding member in a liquid contained in a container; and rotating the first holding member or the second holding member about the central axis so that a first side of the at least one medical sheet material held by the first holding member and a second side of the at least one medical sheet material held by the second holding member collide with each other in the liquid in response to the rotation of the first holding member or the second holding member.

[0016] The rotation speed of the first holding member or the second holding member is preferably in the range of 100 to 5,000 revolutions per minute.

[0017] The temperature of the liquid is preferably 20 to 50°C. [Effects of the Invention]

[0018] The aspects of the present invention have the common effect of providing a durability test device and a durability test method for medical sheet materials that can be carried out simply and in a short time. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 1 is a longitudinal sectional view of a durability testing device for medical sheet materials according to an embodiment of the present invention. [Figure 2] FIG. 2 is a top view of the first and second holding members holding the medical sheet material. [Figure 3] FIG. 3 is a perspective view of the first and second holding members holding the medical sheet material. [Figure 4] FIG. 4 is an exploded perspective view of the first and second holding members holding the medical sheet material. [Figure 5] FIG. 5 is an exploded perspective view of the first and second holding members when they are not holding a medical sheet material. [Figure 6] FIG. 6 is a perspective view of the mounting member. DETAILED DESCRIPTION OF THE INVENTION

[0020] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings. Corresponding components throughout the drawings are designated by common reference numerals.

[0021] Fig. 1 is a longitudinal cross-sectional view of a durability testing device 1 for medical sheet material 6 according to an embodiment of the present invention. Fig. 2 is a top view of first holding member 10 and second holding member 20 holding medical sheet material 6, Fig. 3 is a perspective view of first holding member 10 and second holding member 20 holding medical sheet material 6, Fig. 4 is an exploded perspective view of first holding member 10 and second holding member 20 holding medical sheet material 6, and Fig. 5 is an exploded perspective view of first holding member 10 and second holding member 20 not holding medical sheet material 6.

[0022] The medical sheet material 6 may be any medical sheet material, for example, a valve leaflet material for artificial valves such as cardiac artificial valves, and medical patches other than artificial valves. The medical sheet material 6 includes, for example, hydrogel.

[0023] The durability testing device 1 has a first holding member 10 having a central axis C, and a second holding member 20 that surrounds the first holding member 10 and has a common central axis C with the first holding member 10. The first holding member 10 is configured to be able to hold a medical sheet material 6 so as to protrude radially outward from the central axis C. The second holding member 20 is configured to be able to hold a medical sheet material 6 so as to protrude radially inward from the central axis C.

[0024] The durability testing device 1 may include a rotational drive mechanism 2 and a container 3. The rotational drive mechanism 2 is connected to the first holding member 10 via a rotating shaft 11 whose rotation axis is a central axis C. The rotational drive mechanism 2 is connected to a control device (not shown) and can rotate the first holding member 10 around the central axis at a predetermined rotation speed and a predetermined variation pattern of the rotation speed. The container 3 can contain a liquid 4 so that the first holding member 10, the second holding member 20, and the medical sheet material 6 held by the first holding member 10 and the second holding member 20 are completely immersed in the liquid.

[0025] The first holding member 10 has a shaft base 12 attached to a rotating shaft 11. The shaft base 12 is a columnar member having a regular octagonal shape. The end of the rotating shaft 11 is inserted into the center of the shaft base 12, and the shaft base 12 is detachably attached to the rotating shaft 11. Four first mounting surfaces 13 are provided alternately on the eight rectangular peripheral surfaces of the shaft base 12 that form the regular octagonal shape. Four corresponding mounting members 30 are detachably attached to the four first mounting surfaces 13. A medical sheet material 6 is attached to each of the mounting members 30. Thus, four medical sheet materials 6 are attached to the first holding member 10.

[0026] The second holding member 20 has an annular base 21, an annular, flat bottom plate 22 spaced apart from the base 21 along the central axis C, and eight support members 23 connecting and securing the base 21 and the bottom plate 22. The base 21 is an octagonal annular member. One end of the support members 23 is attached to a portion corresponding to the vertices of the octagon. The other end of the support members 23 is attached to the upper surface of the bottom plate 22. Eight second mounting surfaces 24 facing the central axis C are provided on the inner surface of a portion corresponding to the sides between the vertices of the octagon. Eight corresponding mounting members 30 are detachably attached to the eight second mounting surfaces 24. A medical sheet material 6 is attached to each of the mounting members 30. Thus, eight medical sheet materials 6 are attached to the second holding member 20. The attachment member 30 attached to the first holding member 10 and the attachment member 30 attached to the second holding member 20 are the same.

[0027] FIG. 6 is a perspective view of the mounting member 30. The mounting member 30 includes a cylindrical insertion portion 31, a female thread portion 32 provided along the central axis of the insertion portion 31, a plate-shaped support portion 33 extending radially outward from the insertion portion 31, a recess 34 formed by cutting a rectangular portion of the side of the support portion 33 along the axis of the insertion portion 31, and a rectangular fixing plate 35 formed complementary to the recess 34. The medical sheet material 6 is formed, for example, into an elongated rectangle. In this embodiment, the medical sheet material 6 is a rectangle measuring 1 cm x 5 cm. One end of the medical sheet material 6 is placed in the recess 34 of the support portion 33 and is clamped together with the fixing plate 35 by two bolts 7. This allows the medical sheet material 6 to be detachably attached to the mounting member 30.

[0028] 5, each first mounting surface 13 of the first holding member 10 is formed with a first insertion groove 14 extending upward from the lower end of the axle base 12. A first through hole 15 is provided in the upper surface of the axle base 12 corresponding to the first insertion groove 14. Each second mounting surface 24 of the second holding member 20 is formed with a second insertion groove 25 extending upward from the lower end of the pedestal 21. A second through hole 26 is provided in the upper surface of the pedestal 21 corresponding to the second insertion groove 25.

[0029] The mounting member 30 with the medical sheet material 6 attached is attached to the first holding member 10 by inserting the insertion portion 31 and support portion 33 of the mounting member 30 into the first insertion groove 14 from below the base 12. In other words, the first insertion groove 14 is formed to be able to receive the insertion portion 31 and support portion 33 of the mounting member 30. After the mounting member 30 has been inserted into the first insertion groove 14, the bolt 7 is threaded from above through the first through-hole 15 into the female thread portion 32, completing the mounting of the mounting member 30 to the base 12.

[0030] Similarly, the mounting member 30 with the medical sheet material 6 attached is attached to the second holding member 20 by inserting the insertion portion 31 and support portion 33 of the mounting member 30 into the second insertion groove 25 from below the base 21. In other words, the second insertion groove 25 is formed to be able to receive the insertion portion 31 and support portion 33 of the mounting member 30. After the mounting member 30 has been inserted into the second insertion groove 25, the bolt 7 is threaded from above through the second through-hole 26 into the female thread portion 32, thereby completing the mounting of the mounting member 30 to the base 21.

[0031] The attachment member 30 may be configured in any manner as long as it is capable of attaching the medical sheet material 6 and is configured to be detachable from the first holding member 10 and the second holding member 20. The first holding member 10, the second holding member 20, and the attachment member 30 may also be configured so that the attachment member 30 is attached to the first holding member 10 and the second holding member 20 by a method other than threading, such as fitting. The first holding member 10 and the second holding member 20 may also be configured so that the medical sheet material 6 is attached directly to the first holding member 10 and the second holding member 20 without the attachment member 30.

[0032] Once the attachment is complete, as shown in FIG. 2 , the medical sheet material 6 held by the first holding member 10 is positioned so that it protrudes radially outward relative to the central axis C, and the medical sheet material 6 held by the second holding member 20 is positioned so that it protrudes radially inward relative to the central axis C. At this time, the mounting members 30 attached to the peripheral surface of the octagonal base 12 and the medical sheet material 6 held on the base 12 by the mounting members 30 are arranged at equal intervals on a circle centered on the central axis C. Similarly, the mounting members 30 attached to the inner surface of the octagonal base 21 and the medical sheet material 6 held on the base 21 by the mounting members 30 are arranged at equal intervals on a circle centered on the central axis C. The medical sheet material 6 held by the first holding member 10 and the medical sheet material 6 held by the second holding member 20 are arranged to overlap by a distance L in the radial direction. The overlap distance L can be easily adjusted by changing the dimensions of the medical sheet material 6. Moreover, the overlapping distance L may be adjusted by changing the size of the shaft base 12 of the first holding member 10 or the size of the base 21 of the second holding member 20.

[0033] As described above, the attachment member 30 attached to the first holding member 10 and the attachment member 30 attached to the second holding member 20 are identical. Furthermore, the medical sheet material 6 attached to the attachment member 30 is identical in terms of shape, dimensions, material, and other characteristics. Therefore, before conducting a durability test on the medical sheet material 6 using the durability testing device 1, the medical sheet material 6 can be attached to multiple attachment members 30. In this case, the user can perform the attachment work without being aware of whether the prepared attachment member 30 is for the first holding member 10 or the second holding member 20. Furthermore, the same bolt 7 can be used to attach the attachment member 30 to the first holding member 10 and the second holding member 20, and to clamp the medical sheet material 6 between the support portion 33 and the fixing plate 35. This allows the user to more smoothly attach and detach the attachment member 30 and the medical sheet material 6.

[0034] Next, a durability test method using the durability test device 1 for medical sheet materials 6 will be described.

[0035] First, the desired number of mounting members 30, each with a medical sheet material 6 attached thereto, are attached to the first holding member 10 and the second holding member 20. Next, the second holding member 20 is placed in a container 3 containing a liquid 4. The second holding member 20 is free-standing on the bottom surface of the container 3 via a bottom plate 22. Next, the first holding member 10 is placed so that it is surrounded by the second holding member 20 and their central axes are aligned. The first holding member 10 is suspended by a rotation drive mechanism 2 via a rotation shaft 11, and its height is adjusted. The first holding member 10 may be configured to be free-standing and rotatable on the bottom surface of the container 3. In this state, the medical sheet material 6 held by the first holding member 10 and the second holding member 20 is positioned so that it is immersed in the liquid 4.

[0036] Liquid 4 is preferably water, distilled water, ion-exchanged water, physiological saline, phosphate buffered saline (PBS), or an aqueous solution containing other salts. The temperature of liquid 4 is preferably 20°C to 50°C, more preferably 25°C to 40°C, and even more preferably 35°C to 40°C. In preparation for a decrease in liquid 4 due to evaporation or the like during the durability test, durability test apparatus 1 may further include a liquid supply device configured to maintain a constant level of liquid 4. The liquid supply device includes, for example, a water level sensor, a supply mechanism, and a control device that controls the supply of liquid from the supply mechanism based on detection by the water level sensor.

[0037] The durability test is performed by rotating first holding member 10 in liquid 4, for example, counterclockwise R as shown in FIG. 2 . Rotation drive mechanism 2 allows first holding member 10 to rotate in any direction at any rotation speed. As first holding member 10 rotates, medical sheet material 6 held by first holding member 10 and medical sheet material 6 held by second holding member 20 collide with each other in liquid 4. Specifically, as shown in FIG. 2 , first side 6a of medical sheet material 6 held by first holding member 10 and second side 6b of medical sheet material 6 held by second holding member 20 collide with each other. More specifically, as described above, opposing medical sheet materials 6 are positioned so as to overlap by distance L, and therefore, opposing medical sheet materials 6 collide with each other over at least the length of distance L.

[0038] The rotation speed of the first holding member 10 by the rotation drive mechanism 2 is preferably in the range of 100 to 5,000 revolutions per minute, more preferably 200 to 3,000 revolutions per minute, and even more preferably 300 to 1,000 revolutions per minute. The duration of the durability test is, for example, 24 hours, 48 ​​hours, or 168 hours.

[0039] Collisions between the surfaces of the medical sheet material 6 exert compressive and frictional forces on the medical sheet material 6. Fluid resistance due to the rotation of the medical sheet material 6 causes the medical sheet material 6 to curve, resulting in bending stress. Furthermore, the rotation of the medical sheet material 6 causes tensile stress due to centrifugal force to act on the medical sheet material 6 held by the first holding member 10, and compressive stress due to centrifugal force to act on the medical sheet material 6 held by the second holding member 20. In short, the durability testing device 1 can apply various forces and stresses to the medical sheet material 6, which can cause wear, fatigue failure, and the like to the medical sheet material 6. The durability of the medical sheet material 6 can be evaluated by measuring or observing the degree of wear, fatigue failure, and the like of the medical sheet material 6.

[0040] In the durability testing apparatus 1, the first holding member 10 is rotated about the central axis C, while the second holding member 20 is stationary. However, a rotation drive mechanism may be connected to the second holding member 20, and the second holding member 20 may be rotated about the central axis C while the first holding member 10 is stationary. The direction of rotation of the first holding member 10 may be reversed during the durability testing. This allows the opposite sides of the first surface 6a and the second surface 6b of the medical sheet material 6 to collide, resulting in both surfaces of the medical sheet material 6 colliding.

[0041] During one rotation of the first holding member 10, each of the four medical sheet materials 6 held by the first holding member 10 collides in turn with the eight medical sheet materials 6 held by the second holding member 20, resulting in eight collisions. In other words, during one rotation of the first holding member 10, each of the eight medical sheet materials 6 held by the second holding member 20 collides in turn with the four medical sheet materials 6 held by the first holding member 10, resulting in four collisions. By making the number of medical sheet materials 6 held by the first holding member 10 and the number of medical sheet materials 6 held by the second holding member 20 different, two tests with different numbers of collisions can be conducted simultaneously.

[0042] The axle base 12 of the first holding member 10 and the seat 21 of the second holding member 20 may be interchangeable depending on the desired number of medical sheet materials 6, i.e., so that the desired number of medical sheet materials 6 can be held. That is, the first holding member 10 and the second holding member 20, each having the first insertion groove 14 or the second insertion groove 25, may be interchangeable so that mounting members 30 corresponding to the desired number of medical sheet materials 6 can be attached. For example, the axle base 12 of the first holding member 10 may be hexagonal, decagonal, or circular. Similarly, the seat 21 of the second holding member 20 may be hexagonal, decagonal, or circular. The axle base 12 of the first holding member 10 and the seat 21 of the second holding member 20 may have different polygonal shapes.

[0043] The number of medical sheet materials 6 held by a first holding member 10 may be at least one, and the number of medical sheet materials 6 held by a corresponding second holding member 20 may be at least one. The number of medical sheet materials 6 held by a first holding member 10 and the number of medical sheet materials 6 held by a second holding member 20 may be the same, and all medical sheet materials 6 may be subjected to the same number of collisions.

[0044] The more medical sheet materials 6 held, the more samples can be evaluated in one test, and the shorter the evaluation period can be, but if there are too many, the durability test apparatus 1 becomes larger and the preparation period for evaluation increases. Therefore, the number of medical sheet materials 6 held in the durability test apparatus 1 is preferably 1 to 24, more preferably 2 to 16, and even more preferably 4 to 12.

[0045] The width of the collision between the medical sheet material 6 held by the first holding member 10 and the medical sheet material 6 held by the second holding member 20, i.e., the aforementioned distance L (see FIG. 2), is preferably 1 mm to 50 mm, more preferably 2 mm to 30 mm, and even more preferably 3 mm to 10 mm. If the distance L is less than 1 mm, it becomes difficult to observe the degree of wear and damage to the medical sheet material 6. If the distance L is greater than 50 mm, the medical sheet material 6 will bend due to fluid resistance during durability testing, making evaluation difficult.

[0046] The medical sheet material 6 may be reinforced to prevent bending or excessive curvature during durability testing. Specifically, a sheet-like reinforcing sheet (not shown) may be placed on the non-impact surface, i.e., the backside of the impact surface, of the medical sheet material 6. Specifically, the reinforcing sheet may be placed on at least one of the backside of the first surface 6a of the medical sheet material 6 held by the first holding member 10 or the backside of the second surface 6b of the medical sheet material 6 held by the second holding member 20. The reinforcing sheet may be sandwiched together with the medical sheet material 6 by the attachment member 30, or may be integrally arranged with the medical sheet material 6 by adhesive or the like. The reinforcing sheet may be placed over the entire length and width of the medical sheet material 6, or over a portion of the length, e.g., half of the length. Reinforcing the medical sheet material 6 reduces curvature or bending of the medical sheet material 6 even during high-speed rotation, ensuring reliable impact.

[0047] Examples of the reinforcing sheet include resin sheets, cloth, rubber sheets, and foam sheets. Examples of the resin sheets include polyolefin-based resin sheets such as polyethylene (PE), polypropylene (PP), and ethylene-propylene copolymers; polyester-based resin sheets such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), and polyethylene naphthalate (PEN); vinyl chloride resin sheets, vinyl acetate resin sheets, polyimide resin sheets, polyamide resin sheets, fluororesin sheets, and cellophane. Examples of the cloth include woven fabrics and nonwoven fabrics made from various fibrous materials, either alone or in combination. Examples of the rubber sheets include natural rubber sheets and butyl rubber sheets. Examples of the foam sheets include foamed polyolefin sheets such as foamed PE sheets, foamed polyester sheets, foamed polyurethane sheets, and foamed polychloroprene rubber sheets. Among these, polyethylene terephthalate (PET) is preferred as the substrate for reasons of physical properties and economy. There are no particular limitations on the thickness of the reinforcing sheet, but by making it within the range of 4 μm to 500 μm, for example, bending of the medical sheet material 6 due to rotation can be suppressed.

[0048] A high rotation speed by the rotation drive mechanism 2 generates vortices in the liquid 4. Depending on the size of the vortex, the medical sheet material 6 may be exposed above the liquid surface 4a, making it impossible to perform an appropriate test. In this case, as shown in FIG. 1 , the durability test apparatus 1 may include a cover member 5 disposed in the liquid 4 or on the liquid surface 4a so as to cover the upper part of the medical sheet material 6 held by the first holding member 10 and the second holding member 20. The cover member 5 has a hole through which the rotating shaft 11 passes, so it does not impede the rotation of the rotating shaft 11. The cover member 5 is a mesh-like member. By disposing the cover member 5, the generation of vortices is suppressed and the exposure of the medical sheet material 6 is prevented. Note that the cover member 5 does not have to be a mesh-like member, but may be, for example, a sheet-like member, and does not have to entirely cover the first holding member 10 and the second holding member 20, as long as it suppresses the generation of vortices.

[0049] The cover member 5 is preferably made of plastic or metal, with plastic being preferred from the viewpoint of corrosion resistance. Examples of materials for the cover member 5 include polyester mesh, nylon mesh, carbon mesh, fluororesin mesh, polypropylene mesh, and silk mesh. Among these, polyester mesh, nylon mesh, and polypropylene mesh are preferred, with polyester mesh being more preferred. From the viewpoint of suppressing vortex generation, the mesh opening of the cover member 5 is preferably 1 to 1,000 μm, more preferably 20 to 600 μm, and even more preferably 100 to 400 μm. From the viewpoint of suppressing vortex generation, the mesh opening ratio is preferably 5 to 90%, and even more preferably 5 to 70%. From the viewpoints of conformability and ease of handling, the film thickness of the cover member 5 is preferably 1 to 1,000 μm, more preferably 10 to 800 μm, and even more preferably 20 to 600 μm.

[0050] The durability testing device 1 for medical sheet materials 6 performs a crash test using a unidirectional rotational motion, eliminating the problem of the inertial forces acting when opening and closing the artificial valve, which makes it difficult to open and close the artificial valve at high speed, as occurs with the commercially available durability testing devices described above. Furthermore, attaching the medical sheet material 6 to the durability testing device 1, i.e., attaching the mounting member 30, can be easily performed by simply fastening the bolts 7. Therefore, the durability testing device 1 allows for more durability tests to be performed in a shorter time, enabling screening to be performed more quickly in the early stages of research on medical sheet materials. In short, the above-described embodiment provides a durability testing device 1 and a durability testing method for medical sheet materials 6 that can be easily performed in a short time. [Explanation of symbols]

[0051] 1. Durability test equipment 2 Rotation drive mechanism 3 containers 4 liquid 5 Cover member 6. Medical sheet materials 6a 1st page 6b 2nd side 7 volts 10 First holding member 11 Rotation axis 12-axis stand 13 First mounting surface 14 First insertion groove 15 First through hole 20 Second holding member 21 Pedestal 22 Bottom plate 23 Support member 24 Second mounting surface 25 Second insertion groove 26 Second through hole 30 Mounting material

Claims

1. A durability testing device for medical sheet materials, comprising: a first retaining member having a central axis and configured to retain at least one of the medical sheet materials so as to protrude radially outward relative to the central axis; a second holding member surrounding the first holding member, having a common central axis with the first holding member, and configured to hold at least one of the medical sheet materials so as to protrude radially inward relative to the central axis; The first holding member or the second holding member is configured to be rotatable around the central axis, A durability testing device configured such that a first side of the at least one medical sheet material held by the first holding member and a second side of the at least one medical sheet material held by the second holding member collide with each other in response to rotation of the first holding member or the second holding member.

2. 2. The durability testing device of claim 1, further comprising a plurality of attachment members configured to be detachable from the first holding member and the second holding member, wherein each of the medical sheet materials is attached to the first holding member or the second holding member via the attachment members.

3. 3. The durability testing device according to claim 1, further comprising a rotation drive mechanism capable of rotating the first holding member or the second holding member.

4. 3. The durability testing device according to claim 1, further comprising a container capable of holding a liquid so that the at least one medical sheet material held by the first holding member and the second holding member is immersed in the liquid.

5. 5. The durability testing device according to claim 4, further comprising a cover member that can be placed in the liquid or on the liquid surface so as to cover the at least one medical sheet material held by the first holding member and the second holding member.

6. 6. The durability testing apparatus according to claim 5, wherein the cover member is a mesh member.

7. 3. The durability testing device of claim 1, further comprising a reinforcing sheet placed on at least one of the backside of the first surface of the at least one medical sheet material held by the first holding member or the backside of the second surface of the at least one medical sheet material held by the second holding member.

8. 3. The durability testing device according to claim 1, wherein the medical sheet material is a valve leaflet material for an artificial valve.

9. A durability test method for medical sheet materials, comprising: holding at least one of the medical sheet materials against a first holding member having a central axis so as to protrude radially outward relative to the central axis; holding at least one of the medical sheet materials relative to a second holding member surrounding the first holding member and having a common central axis with the first holding member so as to protrude radially inward relative to the central axis; immersing the at least one medical sheet material held by the first and second holding members in a liquid contained in a container; rotating the first holding member or the second holding member about the central axis, and causing a first side of the at least one medical sheet material held by the first holding member and a second side of the at least one medical sheet material held by the second holding member to collide with each other in the liquid in response to the rotation of the first holding member or the second holding member.

10. 10. The durability testing method according to claim 9, wherein the rotation of the first holding member or the second holding member is in the range of 100 to 5,000 revolutions per minute.

11. The durability testing method according to claim 9 or 10, wherein the temperature of the liquid is 20 to 50°C.

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