A heart valve stent and an artificial heart valve structure formed thereby

Abstract

The application discloses a heart valve stent and an artificial heart valve structure formed by the heart valve stent. The heart valve stent comprises a stent body and a joint, wherein the joint comprises a fixed part and an elastic stretching part connected with the fixed part, and a movable end is formed at one end of the elastic stretching part away from the fixed part. Through the optimized design of the structure, the service life of the artificial heart valve installed on the stent is greatly prolonged, meanwhile, a material with smaller elasticity can be used to achieve the same valve performance as that of a material with higher elasticity in the prior art, and the leaflet assembly can be closed faster under less external force, and the effect is remarkable.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to a heart valve stent and an artificial heart valve structure thereof. Background Technology

[0002] Most catheter-delivered artificial heart valve stents consist solely of metal elements, either laser-cut from thin-walled tubing or made from fine metal wires, which are then used to construct the desired shape. By assembling a heart valve onto an artificial heart valve stent, an artificial heart valve structure is obtained. This stent-heart valve assembly method allows heart valves to be delivered via catheters with an inner diameter as small as 14 Fr, thus effectively enabling the implementation of transcatheter aortic valve replacement (TAVR).

[0003] In the assembly of artificial heart valve structures, animal-derived tissues are often used as materials to replace valve leaflets in tissue heart valves because they possess elasticity similar to natural valve tissue. However, animal-derived tissues, generally considered a "natural" material, have limitations in long-term durability, which are well documented in academic literature, clinical practice, and datasets. Therefore, transcatheter aortic valve replacement (TAVR) using animal-derived tissue heart valves is generally not recommended for patients under 60 years of age.

[0004] To overcome the limitations of long-term durability, one solution is to replace the leaflet material with synthetic materials known for their high durability and biocompatibility. However, while these animal-derived tissue-based alternatives are ideal due to their high strength and fatigue life, most materials have low elasticity, which limits their use in heart valve leaflet applications. In particular, most leaflet designs considered in the prior art are intended to replicate the anatomical shape and function of natural valves. Since the leaflet assembly has both open and closed states, and the heart valve stent is stiffer than the leaflet material, cyclic loads are generated at the leaflet junction between the leaflet assembly and the heart valve stent when the leaflet assembly is in the closed state, thus affecting its service life.

[0005] For example, the heart valve disclosed in US Patent 10524902B2 uses a leaflet material with significantly less elasticity than natural tissue. The specific assembly method between the leaflet assembly and the heart valve stent is as follows: the leaflet assembly is integrally formed from several leaflets and a suture ring. There is a leaflet junction between adjacent leaflets in this assembly, which is directly fixed to the suture ring and then to the heart valve stent. This structure merely simulates and replicates the anatomical shape and function of a natural valve. In this case, every design described in US Patent 10524902B2 suffers from stress concentration at the fixing position between the leaflet junction and the suture ring, greatly limiting the valve's lifespan. Summary of the Invention

[0006] Therefore, the technical problem to be solved by the present invention is to overcome the defects of the existing structural design that greatly limits the service life of the valve, thereby providing a stent and the artificial heart valve structure thereof that effectively reduces the stress concentrated at the fixed position between the leaflet junction and the suture ring and extends the service life.

[0007] A heart valve stent, comprising:

[0008] Support body;

[0009] A connector, comprising a fixing portion and an elastic tension portion connected to the fixing portion, wherein the end of the elastic tension portion away from the fixing portion is a movable end.

[0010] The connecting member is elongated.

[0011] When the elastic coupling is in its original position, the central axis of the coupling is parallel to the central axis of the support body.

[0012] The elastic stretching part is connected to the leaflet junction, which is the connection between two adjacent leaflets in the artificial heart valve.

[0013] The length of the elastic stretch portion is the same as the length of the leaflet joint; or / and the number of the joints is the same as the number of leaflet joints, with one joint fixed at each leaflet joint.

[0014] The connector is made of a biocompatible elastic material.

[0015] The fixing part and the elastic tensioning part are integrally formed.

[0016] The elastic tension portion extends axially out of the support body.

[0017] The cross-section of the elastic tension section is rectangular.

[0018] An artificial heart valve structure, comprising:

[0019] The aforementioned heart valve stents,

[0020] An artificial heart valve includes leaflet components and a suture ring that holds the leaflet components together. The connection between two adjacent leaflets in the leaflet components is the leaflet junction of the artificial heart valve. The elastic stretch portion is connected to the leaflet junction.

[0021] An artificial heart valve structure, comprising:

[0022] Support body;

[0023] An artificial heart valve includes leaflet components and suture rings that hold the leaflet components together. The connection between two adjacent leaflets in the leaflet components is the leaflet junction of the artificial heart valve.

[0024] The coupling includes a fixing part and an elastic tension part connected to the fixing part, the fixing part being connected to a suture ring and the elastic tension part being connected to a leaflet junction.

[0025] The artificial heart valve is made of woven fabric, and the connector is disposed within the woven fabric.

[0026] The fixing part of the connector is located between the bracket body and the suture ring.

[0027] The connecting member is elongated and its central axis is parallel to the central axis of the support body; the length of the elastic tension part is the same as the length of the leaflet joint.

[0028] The number of the connecting pieces is the same as the number of leaflet joints, with one connecting piece fixed at each leaflet joint.

[0029] The connector is made of a biocompatible elastic material.

[0030] The technical solution of this invention has the following advantages:

[0031] 1. The heart valve stent provided by the present invention includes an additional connecting member. A fixed portion of this connecting member is fixed to the stent body. One end of the elastic tension portion is connected to the fixed portion, and the end away from the fixed portion is a movable end, which is used to connect with the leaflet junction of the artificial heart valve. Through this structural design, when using the stent of this embodiment, a certain amount of movement margin can be provided for the leaflet junction of the artificial heart valve connected to the stent body. This reduces the concentrated stress at the fixed position between the suture ring fixed to the stent body and the leaflet junction, distributing the stress at the fixed position to the entire connecting member, thus greatly extending the service life of the artificial heart valve installed on the heart valve stent.

[0032] Meanwhile, the structure of this invention also allows the elastic tension portion between the leaflet junction and the connector to be tilted towards the center of the valve, which not only reduces stress and extends service life, but also allows the leaflet assembly to be made of a material with less elasticity, achieving valve performance comparable to that achieved by using a more elastic material to make the leaflet assembly in the prior art; at the same time, it also allows the leaflet assembly to close faster with less external force, with significant effects.

[0033] 2. The present invention also provides an artificial heart valve structure having the improved heart valve stent of the present invention, which can achieve the same effect as the above-mentioned heart valve stent.

[0034] 3. This invention provides another artificial heart valve structure. Specifically, when the connector is directly woven or sewn onto the leaflet junction of the leaflet assembly during the artificial heart valve weaving process and fixed onto the existing stent body, it not only achieves the above-mentioned effects of the heart valve stent in this invention, but also effectively increases the thickness of the leaflet junction, thereby better facilitating the positioning of the artificial heart valve on the stent body, simplifying subsequent assembly work, reducing assembly time, and improving assembly efficiency. Attached Figure Description

[0035] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0036] Figure 1 This is a schematic diagram of the artificial heart valve in the open state after it is installed on the stent in this invention;

[0037] Figure 2 for Figure 1 Top view of the structure shown;

[0038] Figure 3 This is a schematic diagram of the artificial heart valve in the closed state after it is installed on the stent in this invention;

[0039] Figure 4 for Figure 3 Top view of the structure shown;

[0040] Figure 5 This is a schematic diagram of the structure of the connector wrapped around the leaflet junction of the artificial heart valve in this invention;

[0041] Explanation of reference numerals in the attached figures:

[0042] 1-Stent body, 2-Connector, 3-Artificial heart valve;

[0043] 31-Leaflet assembly, 32-Suture ring. Detailed Implementation

[0044] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0045] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0046] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0047] Furthermore, 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.

[0048] Example 1

[0049] A type of heart valve stent, such as Figure 1 and Figure 2 As shown, the device includes a stent body 1 and a connector 2. The connector 2 includes a fixing portion and an elastic tension portion; the elastic tension portion is connected to the stent body 1 via the fixing portion; the end of the elastic tension portion away from the fixing portion is a movable end; the movable end is used to connect with the leaflet junction of the artificial heart valve 3. In use, the elastic tension portion includes an initial state and a stretched state where the movable end is offset towards the center of the stent body.

[0050] In this embodiment, a connector 2 is added. The fixing part of this connector is fixed to the stent body. One end of the elastic tension part is connected to the fixing part, and the end away from the fixing part is a movable end, which is used to connect with the leaflet junction of the artificial heart valve. With this structure, when using the stent of this embodiment, a certain amount of movement margin can be provided for the leaflet junction of the artificial heart valve connected to the stent body. This reduces the concentrated stress at the fixing position between the suture ring fixed to the stent body and the leaflet junction, distributing the stress at the fixing position to the entire connector, and greatly extending the service life of the artificial heart valve installed on the heart valve stent.

[0051] Simultaneously, using the structure in this embodiment, for artificial heart valves 3 formed from leaflet materials with a break elongation of less than 20%, 10%, or 5%, when the leaflet assembly closes, because the anchoring point between the stent and the leaflet junction on the leaflet assembly is a connector, which is elastic, the elastic tensile portion of the connector between the leaflet junction and the connector 2 can also be deflected towards the valve center, such as... Figure 3 and Figure 4 As shown, it can not only reduce stress and extend service life, but also achieve valve performance comparable to that of more elastic materials in existing technologies using less elastic materials; at the same time, it can also enable the leaflet assembly to close faster with less external force, with significant effects.

[0052] In this embodiment, the fixing part can be a ring-shaped structure similar to the support body, or it can be a structure of other shapes, as long as it can be fixedly connected to the support body 1. The elastic tension part is used to connect with the leaflet joint, and the connection method includes, but is not limited to, sewing, bonding, welding, or mechanical connection. In this embodiment, the elastic tension part is set as a long strip structure, which is set along the connecting seam between two adjacent leaflets, that is, the elastic tension part is fixed at the leaflet joint, and the number of elastic tension parts is the same as the number of leaflets in the leaflet assembly. Conventional leaflet assemblies have two or three leaflets, and the number of elastic tension parts is also set to two or three accordingly.

[0053] In one embodiment, the connector 2 is elongated, meaning the fixing part and the elastic tension part are integrally formed. One end of the connector 2 is the fixing part, used to fix it to the stent body 1, and the other end is an elastic tension part with a movable end, used to connect to the leaflet junction. Taking the aorta as an example, the artificial heart valve 3 is a tricuspid valve with three leaflets, so the number of connectors 2 on the stent body 1 in this embodiment is also set to three. One connector 2 is fixed at each leaflet junction. The movable end of the elastic tension part can be lower than the top of the stent body 1 in the axial direction, or it can extend beyond the stent body 1. In this embodiment, the elastic tension part extends beyond the stent body in the axial direction. Furthermore, the length of the elastic tension part can be set to be the same as the length of the leaflet junction, such as... Figures 1-4 As shown.

[0054] In this embodiment, the artificial heart valve 3 can be fixed to the connector 2 from the inside side of the stent body 1, or it can be fixed to the connector 2 from the outside side of the stent body 1. This embodiment uses an inside-side fixation method, which minimizes the profile of the artificial heart valve structure transmitted through the catheter and reduces the device wall thickness. In this embodiment, a portion of the surface of the connector 2 can be exposed to the blood flow. Simultaneously, a portion of the connector 2 can be encased within the artificial heart valve 3. When encasing, the elastic stretch portion can be sutured to the leaflet junction of the artificial heart valve 3. Although this method increases the profile transmitted through the catheter, it further reduces the potential risk of tissue reaction, resulting in better efficacy.

[0055] In this embodiment, the connector 2 is preferably made of a biocompatible elastic material, such as thermoplastic polyurethane rubber. The connector 2 is formed by extrusion or injection molding. Through material optimization, tissue reactions caused by surface exposure, such as collagen formation and lobule thickening, can be effectively reduced.

[0056] Let the cross-section perpendicular to the central axis of the elastic tension section be the cross-section. Under the premise of maintaining optimal valve dynamics, the shape of the cross-section of the elastic tension section may vary depending on the shape of the stent used and the connection method between the leaflets and the stent in the artificial heart valve. The cross-section of the elastic tension section can be circular, square, polygonal, irregular, etc. In this embodiment, the cross-section of the elastic tension section is set to a rectangle and is connected to the leaflet junction in the artificial heart valve by adhesive bonding, which effectively meets the minimum valve transport profile requirements.

[0057] Example 2

[0058] An artificial heart valve structure includes the heart valve stent and the artificial heart valve 3 described in Embodiment 1 above; wherein, the artificial heart valve 3 includes leaflet components 31 and suture rings 32 that fix the leaflet components 31 together, and the connection between two adjacent leaflets in the leaflet components 31 is the leaflet junction of the artificial heart valve 3.

[0059] The connection between the artificial heart valve 3 and the heart valve stent is as follows: simply connect the elastic tension portion of the heart valve stent to the leaflet junction of the artificial heart valve 3, and simultaneously fix the suture ring 32 of the artificial heart valve 3 to the stent body 1 of the heart valve stent. The connection method between the elastic tension portion and the leaflet junction, and the fixing method between the suture ring 32 and the stent body 1, include, but are not limited to, sewing, bonding, welding, or mechanical connection.

[0060] Example 3

[0061] An artificial heart valve structure includes a stent body 1, an artificial heart valve 3, and a connector 2. The artificial heart valve 3 includes leaflet components 31 and a suture ring 32 that secures the leaflet components 31 together. The connector 2 includes a fixing portion and an elastic tension portion. The connection between two adjacent leaflets in the leaflet components 31 is the leaflet junction of the artificial heart valve 3. The fixing portion of the connector 2 is connected to the suture ring 32, and the elastic tension portion of the connector 2 is connected to the leaflet junction.

[0062] In this embodiment, the fixing part of the connector 2 can be located between the stent body 1 and the suture ring 32, or the suture ring 32 can be set between the fixing part of the connector 2 and the stent body 1; then, it is only necessary to connect the elastic stretching part to the leaflet junction of the artificial heart valve 3.

[0063] Specifically, when the fixing part is located between the stent body 1 and the suture ring 32, the connector 2 can be completely exposed outside the artificial heart valve 3, that is, the connector 2 is fixed to the outer peripheral surface of the artificial heart valve 3. It is only necessary to ensure that the fixing part is fixedly connected to the suture ring 32 and the elastic tension part is fixedly connected to the leaflet junction. At this time, when the artificial heart valve 3 is fixedly connected to the stent body 1, the connector 2 can be effectively fixed to the stent body 1. At the same time, the elastic tension part can also be embedded in the braid that constitutes the artificial heart valve 3, that is, the elastic tension part is braided or sewn to the leaflet junction of the artificial heart valve 3. In this embodiment, the connector 2 can be made of a biocompatible elastic material, which effectively reduces the tissue reaction in the valve caused by foreign bodies.

[0064] When the suture ring 32 is located between the fixation part and the stent body 1, this embodiment describes in detail the structure of the connector 2 connected to the stent body 1 via the suture ring 32. Specifically, the connector 2 is first fixed to the leaflet junction of the artificial heart valve 3, and then connected to the stent body 1 via the suture ring 32 of the artificial heart valve 3. More specifically, in this embodiment, the artificial heart valve 3 is a woven fabric, and the connector 2 is set as a long strip, which is sutured and wrapped inside the leaflet junction during the weaving of the artificial heart valve 3; or, the connector 2 is set as a single fiber structure, which is woven as a weft thread into the leaflet junction during the weaving of the artificial heart valve 3. This weft thread can be completely sealed inside the leaflet junction of the leaflet assembly with other fibers to reduce the tissue reaction of high-carbon materials in the valve.

[0065] At this point, the leaflet junction of the artificial heart valve 3 merges with the junction piece 2, as shown... Figure 5 As shown, the thickness of the leaflet junction is relatively increased. Due to the increased thickness, it is easier to assemble the artificial heart valve 3 on the stent, effectively shortening the assembly time. Furthermore, the increased thickness of the leaflet junction also effectively reduces the positioning time of the artificial heart valve 3, and the amount of trimming and sewing work after assembly, reducing the workload of subsequent assembly and resulting in a more significant effect.

[0066] Meanwhile, in this embodiment, the number of the connecting member 2 is set to be the same as the number of leaflet joints, with one connecting member 2 fixed at each leaflet joint, such as... Figure 5 As shown. Furthermore, the central axis of each connector 2 is parallel to the central axis of the support body 1, and the length of the elastic tension portion is the same as the length of the leaflet joint.

[0067] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A cardiac valve stent, characterized in that, include: Support body (1); The connector (2) includes a fixing part and an elastic tension part connected to the fixing part, wherein the end of the elastic tension part away from the fixing part is a movable end; The elastic stretching part is connected to the leaflet junction, which is the connection between two adjacent leaflets in the artificial heart valve (3). The artificial heart valve (3) is a woven fabric, and the connector (2) is woven and wrapped inside the leaflet junction during the weaving process of the artificial heart valve (3); or, the connector (2) is set as a single fiber structure, which is woven as a weft thread into the leaflet junction during the weaving of the artificial heart valve (3).

2. The cardiac valve stent according to claim 1, characterized in that, The connector (2) is elongated.

3. The cardiac valve stent according to claim 2, characterized in that, When the elastic coupling (2) is in its original state, the central axis of the coupling (2) is parallel to the central axis of the support body (1).

4. The cardiac valve stent according to claim 2 or 3, characterized in that, The length of the elastic stretching portion is the same as the length of the leaflet joint; or / and the number of the joints (2) is the same as the number of leaflet joints, with one joint (2) fixed at each leaflet joint.

5. The cardiac valve stent according to any one of claims 1-3, characterized in that, The joint (2) is made of a biocompatible elastic material.

6. The cardiac valve stent according to any one of claims 1-3, characterized in that, The fixing part and the elastic tensioning part are integrally formed.

7. The cardiac valve stent according to any one of claims 1-3, characterized in that, The elastic tension portion extends axially out of the support body (1).

8. The cardiac valve stent according to any one of claims 1-3, characterized in that, The cross-section of the elastic tension section is rectangular.

9. An artificial heart valve structure, comprising: The cardiac valve stent according to any one of claims 1-8, The artificial heart valve (3) includes a leaflet assembly (31) and a suture ring (32) that fixes the leaflet assembly (31) together. The connection between two adjacent leaflets in the leaflet assembly (31) is the leaflet junction of the artificial heart valve (3). The elastic stretching part is connected to the leaflet junction.

10. An artificial heart valve structure, characterized in that, include: Support body (1); The artificial heart valve (3) includes leaflet components (31) and suture rings (32) that fix the leaflet components (31) together. The connection between two adjacent leaflets in the leaflet components (31) is the leaflet junction of the artificial heart valve (3). The connector (2) includes a fixing part and an elastic tension part connected to the fixing part, the fixing part being connected to the suture ring (32) and the elastic tension part being connected to the leaflet junction; The artificial heart valve (3) is a woven fabric, and the connector (2) is woven and wrapped inside the leaflet junction during the weaving process of the artificial heart valve (3); or, the connector (2) is set as a single fiber structure, which is woven as a weft thread into the leaflet junction during the weaving of the artificial heart valve (3).

11. The artificial heart valve structure according to claim 10, characterized in that, The fixing part of the connector (2) is located between the bracket body (1) and the suture ring (32).

12. The artificial heart valve structure according to claim 10 or 11, characterized in that, The connecting member (2) is long and its central axis is parallel to the central axis of the support body (1); the length of the elastic tension part is the same as the length of the leaflet joint.

13. The artificial heart valve structure according to claim 10 or 11, characterized in that, The number of the connectors (2) is the same as the number of leaflet joints, and one connector (2) is fixed at each leaflet joint.

14. The artificial heart valve structure according to claim 10 or 11, characterized in that, The joint (2) is made of a biocompatible elastic material.

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