Valve prosthesis fixing tool, fixing tool mold and fixing tool preparation method

Abstract

The valve prosthesis fixing tool, fixing tool mold and fixing tool preparation method provided by the present invention belong to the technical field of medical devices. The valve prosthesis fixing tool comprises: a support body, the center of which has a mounting hole suitable for the valve prosthesis stent to pass through; an annular stent, arranged around the mounting hole; a valve prosthesis ventricular end anchoring structure suitable for being snapped onto the annular stent; the support body and the annular stent are both made of flexible material; an annular hard inlay is embedded in the interior of the support body; in the valve prosthesis fixing tool of the present invention, the valve prosthesis ventricular end anchoring structure is suitable for being snapped onto the annular stent, can simulate the anchoring state of the anchoring structure on the human heart, can accurately measure the fatigue test of the stent body, and can be more prepared to measure the performance of the anchoring structure when in use, providing a more powerful guarantee for later practical application in the human body.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a valve prosthesis fixing tool, a fixing tool mould and a fixing tool preparation method. Background Art

[0002] The mitral valve is located between the left atrium and the left ventricle. The mitral valve ring is not completely surrounded by fibroelastic tissue like the aortic valve, which can provide support by providing its natural structural properties. The mitral valve ring is only bounded to the outer wall by muscle tissue, and there is no radial force.

[0003] Aiming at the structure of mitral valve, the mitral valve prosthesis designed by our company includes: valve stent, valve leaflets and inner and outer skirts of the stent; the valve stent includes a stent body and an anchoring structure, the anchoring structure has an upper atrial end anchoring structure and a lower ventricular end anchoring structure; the atrial end anchoring structure fixes the mitral valve device on the valve, and the ventricular end anchoring structure is clamped and fixed by the diseased valve leaflets; the valve leaflets replace the diseased valve leaflets to form an artificial valve;

[0004] In the existing fatigue test of mitral valve prosthesis, the valve prosthesis is simply clamped and then placed in a fatigue testing device. However, this method cannot well measure the fatigue life of the anchoring structure. Summary of the invention

[0005] Therefore, the technical problem to be solved by the present invention is to overcome the defect that in the fatigue test of the mitral valve prosthesis in the prior art, the valve prosthesis is simply clamped and then placed in a fatigue testing device, but this method cannot well measure the fatigue life of the anchoring structure, thereby providing a valve prosthesis fixing tool.

[0006] The invention also provides a fixed tooling die.

[0007] The invention also provides a method for preparing a fixed tool.

[0008] In order to solve the above technical problems, the present invention provides a fixing tool for a valve prosthesis, comprising:

[0009] A support body having a mounting hole at the center thereof suitable for the valve prosthesis stent to pass through;

[0010] An annular stent is arranged around the mounting hole; the ventricular end anchoring structure of the valve prosthesis is suitable for being snap-fitted to the annular stent;

[0011] The support body and the annular bracket are both made of flexible materials; an annular hard inlay is embedded in the interior of the support body.

[0012] As a preferred solution, the material of the hard inlay is hard plastic or metal material; the support body and the annular bracket are made of soft silicone material.

[0013] As a preferred solution, at least three positioning holes are provided on the hard inlay; the positioning holes are evenly arranged along the circumferential direction of the inlay.

[0014] As a preferred solution, the side surface of the annular bracket away from the mounting hole is inclined from top to bottom.

[0015] As a preferred solution, it also includes:

[0016] An anchoring groove is arranged on the supporting body concentrically with the mounting hole; and the annular bracket is arranged in the anchoring groove.

[0017] As a preferred solution, the hard inlay is provided with an extension end extending toward the center of the circle, and the extension end is embedded in the bottom of the anchoring groove.

[0018] The fixed tooling mold provided by the present invention is used to produce the fixed tooling for the valve prosthesis mentioned above; the fixed tooling mold comprises:

[0019] upper mold;

[0020] The lower mold has a cavity for forming a fixed tool inside; an annular protrusion is arranged at the center of the cavity; the diameter of the annular protrusion is the same as the diameter of the fixed tool; the upper mold is suitable for covering the lower mold;

[0021] A fixing pin is arranged in the cavity of the lower mold; the fixing pin is used to fix the hard inlay.

[0022] As a preferred solution, the upper die has an annular flange extending toward the lower die; the annular flange matches the shape of the anchoring groove of the fixing tool.

[0023] As a preferred embodiment, the center of the upper end of the fixing pin has an extension end; the cross-sectional dimension of the extension end is smaller than the cross-sectional dimension of the fixing pin; an abutment surface is formed between the extension end and the fixing pin; the extension end extends into the positioning hole of the hard inlay, and the abutment surface abuts against the lower surface of the hard inlay.

[0024] The method for preparing a fixed tool provided by the present invention uses the fixed tool mold described above, and comprises the following steps:

[0025] Insert the hard inlay and place it onto the fixing pin of the lower die;

[0026] Inject liquid silicone into the cavity of the lower mold;

[0027] The fixed tooling is formed, and after the upper mold is covered, it is left to stand and wait for forming, and the fixed tooling is taken out.

[0028] As a preferred solution, the positioning hole of the hard inlay is inserted into the protruding end of the fixing pin; and the lower surface of the hard inlay abuts against the abutting surface of the fixing pin.

[0029] The technical solution of the present invention has the following advantages:

[0030] 1. The fixing fixture for valve prosthesis provided by the present invention is mainly used to test the fatigue performance of mitral valve prosthesis, fix the mitral valve prosthesis, and then put it into the fatigue testing device;

[0031] The fixing tool comprises a supporting body and an annular bracket; the supporting body and the annular bracket are both made of flexible materials, which can simulate heart tissue as much as possible, making fatigue testing more accurate;

[0032] The ventricular end anchoring structure of the valve prosthesis is suitable for being clamped on the annular stent, which can simulate the anchoring state of the anchoring structure on the human heart, and can accurately measure the fatigue test of the stent body, and can be more prepared to measure the performance of the anchoring structure when in use, providing a more powerful guarantee for the later practical application in the human body;

[0033] There is a mounting hole inside the support body; during the test, the stent body will be inserted into the mounting hole, and the leaflets and valves on the valve prosthesis can be installed. After being placed in the fatigue test device, the leaflets and the stent body pull each other, which is more in line with the physiological environment; at the same time, the fatigue test of the leaflets and the fatigue test of the stent can be completed on the same device at the same time, saving costs and test time;

[0034] A hard inlay is embedded inside the bracket body, which can solve the problem of deformation of the fixed fixture during the test process.

[0035] 2. The fixing fixture for valve prosthesis provided by the present invention has at least three positioning holes in the hard inlay, so that the hard inlay can be positioned during the casting process of making the fixing fixture.

[0036] 3. The fixing tool for the valve prosthesis provided by the present invention comprises: an anchoring groove for accommodating an anchoring structure.

[0037] 4. The fixed tooling mold provided by the present invention comprises an upper mold, a lower mold and a fixing pin; and is used for producing the fixed tooling described above.

[0038] 5. The method for preparing the fixed tooling provided by the present invention uses the fixed tooling mold to produce the fixed tooling. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0040] Figure 1 It is a schematic diagram of the three-dimensional structure of the fixing tool of the present invention.

[0041] Figure 2 Schematic diagram of the three-dimensional structure of the mitral valve prosthesis.

[0042] Figure 3 It is a schematic diagram of the top structure of the fixing tool of the present invention.

[0043] Figure 4 for Figure 3 AA section view shown

[0044] Figure 5 It is a schematic diagram of the three-dimensional structure of the hard inlay of the present invention.

[0045] Figure 6 It is a top view of the fixed tooling mold of the present invention.

[0046] Figure 7 for Figure 6 The cross-sectional structural schematic diagram along the BB direction.

[0047] Figure 8 It is a schematic diagram of the three-dimensional structure of the upper mold of the fixed tooling mold of the present invention.

[0048] Fig. 9 It is a schematic diagram of the three-dimensional structure of the lower mold of the fixed tooling mold of the present invention.

[0049] Fig.10 The present invention is a flow chart of manufacturing a fixed tool.

[0050] Description of reference numerals:

[0051] 1. Support body; 2. Annular bracket; 3. Anchoring groove; 4. Mounting hole; 5. Bracket body; 6. Atrial end anchoring structure; 7. Ventricular end anchoring structure; 8. Hard inlay; 9. Extended end; 10. Positioning hole; 11. Upper mold; 12. Annular flange; 13. Lower mold; 14. Fixing pin; 15. Extended end; 16. Annular protrusion; 17. Cavity. DETAILED DESCRIPTION

[0052] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0053] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside", etc. indicate directions or positional relationships based on the directions or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction. Therefore, they cannot be understood as limitations on the present invention.

[0054] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0055] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0056] Example 1

[0057] The valve prosthesis fixing tool provided in this embodiment is mainly used to test the fatigue performance of the mitral valve prosthesis. The mitral valve prosthesis is fixed and then placed in the fatigue testing device; Figure 1 As shown, it includes a supporting body 1 and an annular stent 2; the ventricular end anchoring structure 7 of the valve prosthesis is suitable for being snapped onto the annular stent 2, and can simulate the anchoring state of the anchoring structure on the human heart, and can accurately measure the fatigue test of the stent body 5, while being more prepared to measure the performance of the anchoring structure when in use, providing a more powerful guarantee for the later practical application in the human body.

[0058] like Figure 2 As shown, the mitral valve prosthesis tested in this embodiment includes: a valve prosthesis stent, valve leaflets and inner and outer skirts of the stent; the valve prosthesis stent includes a stent body 5 and an anchoring structure, and the anchoring structure has an atrial end anchoring structure 6 at the upper end and a ventricular end anchoring structure 7 at the lower end.

[0059] Specifically, Figure 3 ,4 As shown, the fixing fixture for the valve prosthesis in this embodiment is circular, with a diameter of 86 mm and a height of 12 mm; as an alternative embodiment, the shape may also be rectangular or other shapes, as long as the shape matches the test device;

[0060] The support body 1 has a mounting hole 4 at its center, and an annular bracket 2 is arranged around the mounting hole 4. The side of the annular bracket 2 away from the mounting hole 4 is arranged to be inclined from top to bottom; the ventricular end anchoring structure 7 of the valve prosthesis is suitable for being clamped on the annular bracket 2; an anchoring groove 3 is arranged on the support body 1 concentrically with the mounting hole 4, and the annular bracket 2 is arranged in the anchoring groove 3;

[0061] As an alternative embodiment, the annular bracket 2 may also be directly disposed on the supporting body 1 and extend upward.

[0062] The support body 1 and the annular bracket 2 are both made of flexible material, specifically soft silicone material; a hard inlay 8 is embedded in the support body 1, such as Figure 5 As shown, the hard inlay 8 has an extension end 9 extending toward the center of the circle, and the extension end 9 is embedded in the bottom of the anchoring groove 3. The material of the hard inlay 8 can be hard plastic such as organic glass, PC and other materials, or metal materials can be used. During the fatigue test of the mitral valve prosthesis, due to the effect of pressure, the support body 1 made of flexible material will be deformed, causing the valve prosthesis to move axially, and the test conditions cannot be met. The hard inlay 8 is embedded in the support body 1 to prevent the deformation of the fixing fixture and ensure the test environment of the valve stent.

[0063] Several positioning holes 10 are evenly arranged along the circumferential direction of the hard inlay 8. In this embodiment, 6 positioning holes 10 are arranged. During the casting process, the hard inlay 8 is positioned and fixed by inserting the fixing pins 14 into the positioning holes 10.

[0064] Usage and principle

[0065] The valve prosthesis is installed in the fixing fixture, the atrial end anchoring structure 6 of the valve prosthesis is passed through the installation hole 4, and the ventricular end anchoring structure 7 is placed into the anchoring groove 3, and the valve prosthesis is installed;

[0066] Place the fixture with the valve prosthesis into the fatigue machine, adjust the test pressure of the fatigue machine according to the test requirements, and the test frequency of the fatigue machine is 20Hz-25Hz. Take out the valve prosthesis from the fatigue machine every 50 million times and install it in the pulsometer for testing. When the fatigue life reaches 200 million times, evaluate the fatigue life of the valve leaflets based on the test data of the pulsometer. Replace the leaflets of the test valve prosthesis according to the normal valve sewing process, and continue the fatigue test until the number of tests reaches 400 million times, completing the fatigue test of the stent. The test cycle of the leaflets is about 4 months, and the test cycle of the stent is about 8 months. According to this test method, the test of the valve prosthesis can be completed in 8 months. Each test can evaluate the life of one group of stents and the life of two groups of leaflets. It saves test time and test equipment.

[0067] Example 2

[0068] The fixture mold provided in this embodiment is used to produce the fixture of the valve prosthesis described in Example 1, such as Figure 6 , 7 As shown, the fixing tool includes an upper die 11, a lower die 13 and a fixing pin 14; Figure 8 As shown, the lower mold 13 has a cavity 17 for forming a fixing tool inside, and the upper mold 11 is suitable for covering the lower mold 13. The upper mold 11 has a protruding annular flange 12 at one end facing the lower mold 13, and the shape of the annular flange 12 matches the shape of the anchor groove 3.

[0069] like Fig. 9 As shown, there is a cavity 17 for forming a fixing tool inside the lower mold 13, and an annular protrusion 16 is arranged at the center position of the cavity 17; the diameter of the annular protrusion 16 is the same as the diameter of the fixing tool; there are a number of fixing pins 14 for fixing the hard inlay 8 around the annular protrusion 16, and there are 3 in this embodiment, and the center of the upper end of the fixing pin 14 is provided with a protruding end 15; the cross-sectional size of the protruding end 15 is smaller than the cross-sectional size of the fixing pin 14; abutment surface is formed between the protruding end 15 and the fixing pin 14; the shape of the protruding end 15 is consistent with the shape of the positioning hole 10 on the hard inlay 8, and it is inserted into the positioning hole 10 of the hard inlay 8, and the lower surface of the hard inlay 8 abuts against the abutment surface, so as to realize the positioning and fixation of the hard inlay 8 in the lower mold 13.

[0070] Example 3

[0071] The preparation method of the fixed tooling provided in this embodiment is as follows: Fig.10 As shown, the production of the fixing fixture of the valve prosthesis described in Example 1 using the mold of the fixing fixture provided in Example 2 includes the following steps:

[0072] Put the hard inlay 8, put the pre-prepared hard inlay 8 on the fixing pin 14 of the lower mold 13, specifically, align the positioning hole 10 on the hard inlay 8 with the protruding end 15 on the fixing pin 14, and put it in, so that the lower surface of the hard inlay 8 abuts against the abutting surface of the fixing pin 14, so as to achieve the positioning and fixing of the hard inlay 8;

[0073] Injecting liquid silicone, mixing various raw materials according to the ratio to obtain liquid silicone; injecting the obtained liquid silicone into the cavity 17 of the lower mold 13;

[0074] The fixed tooling is formed, and the upper mold 11 is covered. After being still for about 3 hours, the fixed tooling is formed and the fixed tooling is taken out from the mold; after being taken out, there will be small holes at the bottom of the tooling due to the existence of the fixing pin 14, which can be filled with glue.

[0075] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. A fixing device for a valve prosthesis, characterized in that: The fixture is used to test the fatigue performance of mitral valve prostheses, including: A support body (1) having a mounting hole (4) at the center thereof suitable for a valve prosthesis stent to pass through; An annular support (2) is arranged around the mounting hole (4); the ventricular end anchoring structure (7) of the valve prosthesis is suitable for being snap-fitted onto the annular support (2); The support body (1) and the annular bracket (2) are both made of flexible material; an annular hard inlay (8) is embedded inside the support body (1); An anchoring groove (3) is arranged on the supporting body (1) concentrically with the mounting hole (4); The anchoring groove (3) is suitable for accommodating the ventricular end anchoring structure (7).

2. The fixing device for valve prosthesis according to claim 1, characterized in that: The material of the hard inlay (8) is hard plastic or metal material; the supporting body (1) and the annular bracket (2) are made of soft silicone material.

3. The fixing device for valve prosthesis according to claim 1, characterized in that: At least three positioning holes (10) are arranged on the hard inlay (8); the positioning holes (10) are evenly arranged along the circumferential direction of the inlay.

4. The fixing tool for valve prosthesis according to any one of claims 1 to 3, characterized in that: Also includes: The annular support (2) is arranged in the anchoring groove (3).

5. The fixing device for valve prosthesis according to claim 4, characterized in that: The hard inlay (8) is provided with an extension end (9) extending toward the center of the circle, and the extension end (9) is embedded in the bottom of the anchoring groove (3).

6. Fixed tooling mold, characterized in that, A fixing tool for producing the valve prosthesis according to any one of claims 1 to 5; the fixing tool mold comprises: Upper mold(11); The lower mold (13) has a cavity (17) inside for molding a fixed tool; an annular protrusion (16) is provided at the center of the cavity (17); the diameter of the annular protrusion (16) is the same as the diameter of the fixed tool; the upper mold (11) is suitable for covering the lower mold (13); A fixing pin (14) is arranged in a cavity (17) of the lower mold (13); the fixing pin (14) is used to fix the hard inlay (8).

7. The fixed tooling mold according to claim 6, characterized in that: The upper die (11) has an annular flange (12) extending toward the lower die (13); the annular flange (12) matches the shape of an anchoring groove (3) of a fixing tool.

8. The fixed tooling mold according to claim 6, characterized in that: The center of the upper end of the fixing pin (14) has a protruding end (15); the cross-sectional dimension of the protruding end (15) is smaller than the cross-sectional dimension of the fixing pin (14); an abutting surface is formed between the protruding end (15) and the fixing pin (14); the protruding end (15) extends into the positioning hole (10) of the hard inlay (8), and the abutting surface abuts against the lower surface of the hard inlay (8).

9. A method for preparing a fixed tool, characterized in that: Using the fixed tooling mold according to any one of claims 6 to 8 comprises the following steps: Insert the hard inlay (8), and place the hard inlay (8) onto the fixing pin (14) of the lower mold (13); Injecting liquid silicone into the cavity (17) of the lower mold (13); After the fixed tooling is formed and covered with the upper mold (11), it is left to stand and wait for forming, and the fixed tooling is taken out.

10. The method for preparing a fixed tool according to claim 9, characterized in that: The positioning hole (10) of the hard inlay (8) is inserted into the protruding end (15) of the fixing pin (14); the lower surface of the hard inlay (8) abuts against the abutment surface of the fixing pin (14).

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