Prosthetic valve device

Abstract

The present disclosure provides a prosthetic valve device comprising a stent comprising a plurality of struts; at least two leaflets, each leaflet comprising a fixed base relative to the stent and an opposite free end; and at least two skirts, each skirt comprising a main body extending along an axial and a circumferential direction of the prosthetic valve device, and two shoulder sleeves extending from a first side and a second side of the main body, respectively, opposite each other in the circumferential direction, wherein the top side of the main body is connected to one of the at least two leaflets, and the first and second sides of the main body are connected to the stent via the shoulder sleeves, respectively. The prosthetic valve device of the present disclosure sutures the leaflets to the skirts, and then sutures the skirts to the stent, such that the skirts act as a cushioning component between the leaflets and the stent, which can cushion the pulling action on the leaflets, thereby avoiding the leaflets from being damaged or mechanically failed in this area when the leaflets are closed.

Description

Technical Field

[0001] This disclosure relates to artificial valve devices, and more particularly to an artificial valve device with an improved connection method. Background Technology

[0002] Heart valves are an important part of the heart. During heart function, they constantly open and close to ensure normal blood circulation. When valves malfunction due to congenital or acquired diseases, preventing them from opening and closing properly, it can have a significant impact on a person's health and life. In such cases, replacement with an artificial heart valve can be a treatment option.

[0003] Currently used artificial heart valves are mainly divided into surgical implantation type and transcatheter interventional type based on their implantation characteristics. Most existing interventional valves consist of a stent, leaflets, and a skirt, with the leaflets and skirt sutured to the stent. After valve implantation, the implanted leaflets replace the diseased original leaflets, while the implanted skirt improves paravalvular leakage. In existing products, because the leaflets are directly sutured to the stent or other metal components on the stent, when the leaflets close, they directly pull on the stent or its metal components. There is no stress buffer between the leaflets and the metal, causing stress to concentrate on the leaflets, whose mechanical strength is far lower than that of the metal material. This makes the leaflets prone to mechanical failure, such as leaflet tearing or breakage, leading to serious consequences such as functional failure of the entire artificial heart valve.

[0004] Therefore, it is desirable to provide an improved artificial valve device that addresses the aforementioned shortcomings of the prior art. Summary of the Invention

[0005] This disclosure provides an artificial valve device including a stent, at least two leaflets, and at least two skirts. The stent includes a plurality of links, each of the at least two leaflets includes a bottom edge fixed relative to the stent and an opposite free end, and each of the at least two skirts includes a body extending axially and circumferentially along the artificial valve device, and two rotator cuffs extending circumferentially opposite first and second sides from the body, respectively. The top side of the body is connected to one of the at least two leaflets, and the first and second sides of the body are connected to the stent at least via the rotator cuffs.

[0006] In one embodiment, the top side of the main body includes an arcuate edge, the bottom edges of at least two leaflets are arcuate, the arcuate edges of at least two main bodies are respectively connected to the bottom edges of at least two leaflets, and the leaflets are not directly connected to the support.

[0007] In one embodiment, the arcuate edges of at least two main bodies are concave arcuate edges facing the main body direction, and the tops of the arcuate edges of adjacent main bodies are respectively connected to the bracket and interconnected to form a connection point.

[0008] In one embodiment, each shoulder sleeve is connected to the support at least on the link where the connection point is located, and the shoulder sleeve is folded onto the body around the connection point.

[0009] In one embodiment, the rotator cuff is triangular, quadrilateral, or arc-shaped in a cross-section along the central axis of the artificial valve device.

[0010] In one embodiment, the shoulder sleeve is shaped like a right triangle, with one vertical side of the right triangle coinciding with at least a portion of the first or second side of the body, the other vertical side of the right triangle being perpendicular to the first or second side, and the angle between the hypotenuse of the right triangle and the first or second side being in the range of 20° to 70°.

[0011] In one embodiment, multiple cross-sections are formed between the multiple links of the stent, and the first and second sides of the main body are respectively sutured to the multiple cross-sections along the axial direction of the artificial valve device.

[0012] In one embodiment, the number of at least two lobes corresponds to the number of at least two skirts.

[0013] In one embodiment, the skirt is made of an elastic polymer material or an elastic biomaterial.

[0014] In one embodiment, the skirt and the petals are connected by stitching; the skirt and the support are also connected by stitching.

[0015] According to the artificial valve device of this disclosure, by sewing the leaflets to the skirt and then sewing the skirt to the support, the skirt acts as a buffer component between the leaflets and the support, buffering the traction on the leaflets and thus preventing damage or mechanical failure of the leaflets in this area when the leaflets close. Furthermore, after the skirt is sewn to the support, the shoulder sleeve of the skirt is folded onto the main body and sewn to the support, thereby attaching a reinforced area with increased thickness at the connection point. This reinforced area strengthens the connection point and makes the area flat and easy to grip, thus facilitating operation. Attached Figure Description

[0016] The embodiments of this disclosure are further illustrated below by way of example with reference to the accompanying drawings, which form part of this specification. In the drawings:

[0017] Figure 1A and Figure 1B This is a front view of an artificial valve device according to an exemplary embodiment;

[0018] Figure 2A This is a front view of the skirt and leaflets of an artificial valve device according to an exemplary embodiment, when not installed onto a support.

[0019] Figure 2B and Figure 2C yes Figure 2A A front view of the skirt hem;

[0020] Figure 3A and Figure 3B This is another front view of an artificial valve device according to an exemplary embodiment; Detailed Implementation

[0021] Through the following detailed description of embodiments of the present disclosure in conjunction with the accompanying drawings and specific embodiments, those skilled in the art will gain a clearer and more thorough understanding of the further features, advantages, and effects of the present disclosure. In the following description, spatial and directional terms such as “upper,” “lower,” “front,” “rear,” “left,” “right,” “top,” “bottom,” “vertical,” and “horizontal” may be used to describe embodiments of the present disclosure. However, it should be understood that these terms are merely for the convenience of describing the embodiments shown in the figures and do not require the actual device to be constructed or operated in a specific orientation. In the following description, the use of terms such as “connect,” “joint,” “fixed,” and “attached” can refer to a direct connection between two elements or structures without other elements or structures, or to an indirect connection between two elements or structures through an intermediate element or structure, unless otherwise expressly stated herein. The use of ordinal numbers such as “first” and “second” is merely to distinguish the elements they refer to from one another and does not have any sequential or priority meaning, unless otherwise expressly stated herein.

[0022] First refer to Figure 1A The basic structure of an artificial valve device 100 according to an exemplary embodiment is described below. As shown, the artificial valve device 100 according to an exemplary embodiment includes a skirt 110, leaflets 120, and a stent 130. The stent 130 is a generally cylindrical structure composed of a plurality of links, with a plurality of intersections formed between the links. In some embodiments, the links may be made of materials such as superelastic alloys or shape memory alloys, such that the artificial valve device 100 with the stent 130 can radially contract and expand. In some embodiments, the artificial valve device 100 may include a plurality of leaflets 120, for example, two (in the case of the mitral valve) or three (e.g., in the case of the aortic valve or tricuspid valve, such as...). Figure 1A ,and Figure 3A (As shown). In some embodiments, the number of skirts 110 may correspond to the number of lobes 120. Figure 1B It shows Figure 1A The stitching method between the skirt 110, leaflets 120 and support 130 will be described in detail below.

[0023] Next, combine Figures 2A to 2CThe schematic diagram illustrates in detail the basic structure, connection relationship, and principle of the skirt 110 and leaflet 120 in the artificial valve device 100 according to an exemplary embodiment, so as to provide a further understanding of the embodiment of the entire artificial valve device 100. Figures 2A to 2C This is a front view of the skirt and leaflets of an artificial valve device according to an exemplary embodiment, without being attached to the stent. From the perspective of the front view of leaflet 120, the upper leaflet 120 is crescent-shaped, and the bottom edge 122 of leaflet 120 is arc-shaped. From the front view of the artificial valve device 100, the bottom edge 122 of leaflet 120 is fixed relative to the stent 130. Furthermore, leaflet 120 also has a free end opposite to the bottom edge 122. Depending on the actual needs, in various embodiments, leaflet 120 can be, for example, an aortic valve, pulmonary valve, mitral valve, and tricuspid valve, and can be made of artificial materials or biological tissue.

[0024] The skirt 110 is positioned below the leaflet 120 to prevent perivalvular leakage. The structure of the skirt 110 is as follows: Figure 2B and 2C As shown, the skirt 110 includes a main body 112 extending axially and circumferentially along the artificial valve device 100, and two shoulder sleeves 114 extending from the left side 112-2 and the right side 112-3 of the main body 112, respectively (the area of ​​the shoulder sleeves 114 is in...). Figure 2C (Illustrated by triangles). It should be noted that the number and position of the skirts generally correspond to the number and position of the leaflets. Each skirt has two rotator cuffs. Specifically, if the valve is an aortic valve or tricuspid valve (e.g....),... Figure 1A and Figure 3A As shown in the diagram, the number of shoulder sleeves is 6. Furthermore, Figure 1A and Figure 3A Only one or two skirts facing the observer are shown; the view of the skirt on the side away from the observer is not provided. The left side 112-2 and right side 112-3 of the main body 112 are connected to the support 130, and the connection method will be described in detail below. The top side 112-1 of the main body 112 is connected to the leaflet 120. Specifically, the top side 112-1 of the main body 112 includes an arcuate edge, which is an arcuate shape concave towards the main body 112, and is sutured to the corresponding arcuate bottom edge 122 of the leaflet 120 by a suture 142. The two ends of the top side 112-1 of the main body 112 are connected to the leaflet 120 to form apexes. The position of the suture 142 in the artificial valve device 100 is as follows... Figure 1B As shown. Furthermore, the tops of the curved edges of adjacent main bodies 112 are respectively connected to the bracket 130 and interconnected to form connection points 124. It should be noted that, combined with... Figures 1A to 2AAs can be seen, the skirt 110 is connected to the bottom edge of the leaflet 120, so that the leaflet 120 is not directly connected to the support. Therefore, the movement of the leaflet 120 is not directly restricted by the support 130, and the stress on the support 130 is not directly transferred to the leaflet 120. In this embodiment, the artificial valve device avoids interference from the support during the movement of the leaflet 120, enhances the mobility of the leaflet, and avoids incomplete leaflet closure; on the other hand, it increases the buffer between the leaflet and the support, thereby reducing the stress on the leaflet, reducing the possibility of mechanical failure of the leaflet and the connection between the leaflet and the skirt and support, thereby extending the life of the leaflet. In addition, from Figure 1B As can be seen, the shoulder sleeves 114 on both sides of the main body 112 are connected to the bracket 130 and folded onto the main body 112 to form the reinforced area 132. Details regarding the reinforced area will be described below.

[0025] Continue to refer to Figures 2A to 2C In various embodiments, the shoulder sleeve 114 or the body 112 may have different shapes. Depending on the actual needs, the shape of the shoulder sleeve 114 may include a triangle, a quadrilateral, or an arc in a cross-section along the central axis of the artificial valve device 100. In the embodiments shown in this disclosure, each shoulder sleeve 114 is a right-angled triangle when viewed from the front view. One vertical side of the right-angled triangle coincides with at least a portion of the left side 112-2 or the right side 112-3 of the body 112, and its other vertical side is perpendicular to the left side 112-2 or the right side 112-3 of the body 112. The angle between its hypotenuse and the left side 112-2 or the right side 112-3 of the body 112 is, for example, in the range of 20 to 70°. In some embodiments, the hem 110 may be a one-piece component made of an elastic polymer material or an elastic biomaterial. It should be noted that "at least two skirts" in this document also includes the case where the at least two skirts are integrally formed cylindrical skirts. In one embodiment, each skirt in the cylindrical skirt has two rotator cuffs, therefore it has at least four rotator cuffs. Specifically, if the valve is the aortic valve or tricuspid valve (e.g. Figure 1A and Figure 3A (As shown), the number of shoulder sleeves is 6. Elastic polymer materials include, for example, silicone rubber and polyurethane. Elastic biomaterials include, for example, bovine pericardium and porcine pericardial tissue. It should be noted that the division of the skirt hem 110 into the main body 112 and shoulder sleeves 114 in this disclosure is solely for functional considerations and ease of explanation, and the left side 112-2 or right side 112-3 used to divide the boundary between the main body 112 and shoulder sleeves 114 is merely illustrative; this will be described in more detail below.

[0026] Furthermore, it should be emphasized again that although spatial and directional terms such as “up,” “down,” “left,” “right,” “top,” “bottom,” “vertical,” and “horizontal” are used in the description above and below, these terms are only for the convenience of describing the embodiments shown in the figures. Those skilled in the art will understand that when the orientation of the device or component in the embodiment is changed, these corresponding terms should obviously change accordingly.

[0027] Next reference Figure 3A and Figure 3B The artificial valve device 100 according to an exemplary embodiment is described below to further explain the principles and advantages of this disclosure. As mentioned above, the artificial valve device 100 is suitable for the tricuspid valve. Figure 3B As can be seen more clearly, the top side 112-1 of the main body 112 of the skirt 110 and the top of the shoulder sleeve 114 are respectively sewn to the bottom edge of the leaflet 120 by suture line 142. The left side 112-2 and right side 112-3 of the main body 112 can be longitudinally sewn along the axial direction of the artificial valve device 100 to multiple intersections between multiple links of the stent 130 via suture line 144. It should be noted that, according to the embodiment of this disclosure, the leaflet 120 is directly connected to the skirt 110 and not directly connected to the stent 130. In this embodiment, the artificial valve device avoids interference from the stent during the movement of the leaflet 120, enhances the mobility of the leaflet, and avoids the phenomenon of incomplete leaflet closure; on the other hand, it increases the buffer between the leaflet and the stent, thereby reducing the stress on the leaflet, reducing the possibility of mechanical failure of the leaflet and the connection between the leaflet and the skirt and the stent, thereby extending the life of the leaflet. Furthermore, it should be understood that the stitching method between the skirt 110 and the support 130 can be arbitrary. The stitching method along the longitudinal seam line in this disclosure is only one example. Depending on actual needs, the skirt and support can be stitched at multiple locations on the support to better secure the skirt. Additionally, it can be more easily seen here that... Figure 2B The left side 112-2 of the main body 112 of a skirt 110 and the right side 112-3 of the main body 112 of the adjacent skirt 110 are defined in... Figure 3A The longitudinal sutures 144 shown in the diagram connect or overlap. In other words, the right side 112-3 of a skirt 110 is located to the left of the suture 144, while the left side 112-2 of another (adjacent) skirt 110 is located to the right of the suture 144. In other words, the specific positions of the left side 112-2 or the right side 112-3 are actually defined relative to the position of the aforementioned suture 144, and are therefore not merely geometric definitions. In other embodiments, the main bodies 112 of three or more skirts 110 are arranged and stitched together along the circumference of the artificial valve device 100, and the present invention is not limited to this.

[0028] The following is for reference. Figures 1A to 3B This document describes in detail how the skirt 110 and leaflet 120 are fixed to the support 130. In conventional artificial valve devices, the leaflets and skirt of the valve are directly sewn to the support. Therefore, when the leaflet closes, it directly pulls on the support, causing the support to transfer stress directly to the leaflet in the reverse direction. This makes the leaflet prone to mechanical failure, such as leaflet tearing or breakage. In the embodiments according to this disclosure, the leaflet 120 is first sewn to the skirt 110, including sewing to the body 112 and the apex. Then, the skirt 110 is sewn to the support 130, and the shoulder sleeves 114 on both sides are folded inward toward their respective bodies 112. Finally, the shoulder sleeves 114 are sewn to the connecting rod near the connection point 124. It should be noted again that the "apex" in this document refers to the connection point between the two ends of the top side 112-1 of the body 112 and the leaflet 120. The design of directly sewing the leaflet 120 to the skirt 110 prevents the leaflet 120 and the support 130 from being directly connected. Therefore, the support 130 does not directly transfer stress to the leaflet 120, thus avoiding various problems caused by directly sewing the leaflet to the support in existing technologies. Specifically, in... Figure 2A Within the region of the arc-shaped bottom edge 122 of the leaflet 120, the skirt 110 acts as a buffer component between the leaflet 120 and the support 130, preventing the leaflet from pulling on the support and buffering the reverse stress of the support on the leaflet. This prevents damage to the leaflet in this area during leaflet closure, thus avoiding mechanical failure. Furthermore, using the elastic skirt 110 as a component connecting the leaflet 120 and the support 130 enhances the mobility of the leaflet 120 itself. Therefore, without changing the leaflet size, greater mobility ensures sufficient margin for complete closure during post-implantation movement, better preventing post-implantation reflux. To better achieve the above technical effects, the polymer or biomaterial used to make the skirt should possess excellent elasticity, tensile strength, and biocompatibility. It should be noted that when the rotator cuff 114 is not yet sutured to the support 130, its shape is as follows... Figure 2A As shown, the hypotenuse of the triangular-shaped shoulder sleeve 114 extends freely. When the shoulder sleeve 114 is sewn to the support 130, as described above, two adjacent shoulder sleeves 114 of adjacent hems 110 are sewn together axially, and the free end of the shoulder sleeve 114 extends radially inward. Therefore... Figure 3B The shoulder sleeve 114 looks with Figure 2A The outward-facing shoulder sleeve 114 is different.

[0029] The following is a reference. Figure 3A and Figure 3B To describe the artificial valve device 100 according to an exemplary embodiment, further advantages of the artificial valve device will be illustrated, particularly the function of the shoulder sleeve 114 of the skirt 110. As previously described... Figure 2CAs described, two rotator cuffs 114 extend from the left side 112-2 and right side 112-3 of the main body 112, respectively. In the illustrated embodiment, the rotator cuffs 114 have a right-angled triangular shape. The apexes of the curved edges of adjacent main bodies 112 are connected to the support 130 and interconnect to form connection points 124 (i.e., the circled locations in the figure). It should be noted that in traditional artificial valve devices, the connection point area is where multiple leaflets are connected in pairs and directly to the support. The connection point is a location of relatively concentrated stress, where the stress is greatest. If the strength at the connection point is insufficient, most valves will experience mechanical failure at this location, or the stress borne by the support may be directly transmitted from the connection point to the leaflets, further leading to leaflet mechanical failure.

[0030] To alleviate this problem, after first sewing the leaflets 120 to the skirt hem 110 using the stitching operation described above, and then sewing the skirt hem 110 to the support 130, the shoulder sleeves 114 are folded toward their respective bodies 112, and then the shoulder sleeves 114 are sewn to the connecting rod near the connection point 124, as described above. Figure 1B and 3B As shown. Thus, by folding the shoulder sleeve 114 onto the body 112, a reinforced region 132 with increased thickness is formed below the connection point 124. In an alternative embodiment, the reinforced region 132 can be located in a different position than shown in the figure by changing the shape of the shoulder sleeve and its sewing position; for example, the reinforced region 132 can cover the connection point 124. The reinforced region 132 both strengthens the connection point 124 and makes the area flat and easy to grip, thereby facilitating operation. It should be noted that the reinforced region 132 is the area where the folded shoulder sleeve is located after sewing. Specifically, the reinforced region mainly consists of the overlapping sewn hem. By folding the shoulder sleeve 114 of the hem 110 according to the embodiment of this disclosure onto the body 112, a reinforced region is formed near the connection point 124, thereby strengthening the reinforcement performance at the connection point 124 and improving the problem of conventional leaflets easily failing at the connection point. It should be noted that, as shown above, the shoulder sleeve can be of other shapes, and the fixing effect of the skirt hem and the support can be adjusted by changing the size of the reinforced area.

[0031] In summary, the artificial valve device disclosed herein utilizes specialized suturing between the leaflets and the skirt, and between the skirt and the stent, to ensure that the leaflets are not directly sutured and fixed to the stent. Specifically, by suturing the leaflets to the skirt, and then suturing the skirt to the stent, the skirt acts as a buffer component between the leaflets and the stent, cushioning the traction on the leaflets and preventing damage or mechanical failure of the leaflets in that area during closure. That is, all areas that may transmit stress or cause traction to the leaflets are buffered by the skirt. Furthermore, by using an elastic skirt as a component connecting the leaflets and the stent, the mobility of the leaflets themselves is enhanced, ensuring sufficient leeway for complete closure during post-implantation movement without altering the leaflet size, thus better preventing post-implantation regurgitation. Furthermore, after the skirt hem is sewn to the support, the shoulder sleeve of the skirt hem is folded onto the main body and sewn to the support, thereby forming a reinforced area with increased thickness near the connection point. The reinforced area strengthens the connection point, relieves stress concentration at the connection point, and also makes the area flat and easy to grip, thus facilitating operation.

[0032] Although this disclosure has been described with reference to the foregoing embodiments, those skilled in the art will understand that various changes can be made without departing from the spirit and scope of this disclosure as defined by the appended claims. While this specification contains details of many specific implementations, these should not be construed as limiting the scope of the disclosure, but rather as descriptions of features specific to particular embodiments. The scope of this disclosure is defined by the appended claims and their equivalents, and is not limited to the embodiments described above.

Claims

1. An artificial valve device, characterized in that, include The support frame includes multiple links; At least two leaflets, each leaflet including a base fixed relative to the support and an opposing free end; and At least two skirts, each skirt comprising a body extending axially and circumferentially along the artificial valve device, and two shoulder sleeves extending circumferentially opposite first and second sides from the body, respectively, wherein: The top side of the main body is connected to one of the at least two leaflets. The first side and the second side of the main body are connected to the support via the shoulder sleeve, respectively. The leaflets are not directly connected to the support. The leaflets and the hem are independent components and are connected only by stitching.

2. The artificial valve device as described in claim 1, characterized in that, The top side of the main body includes an arc-shaped edge, and the bottom edges of the at least two leaflets are arc-shaped. The arc-shaped edges of the at least two main bodies are respectively connected to the bottom edges of the at least two leaflets.

3. The artificial valve device as described in claim 2, characterized in that, The arcuate edges of at least two of the main bodies are concave arcuate shapes facing the main body, and the top ends of the arcuate edges of adjacent main bodies are respectively connected to the bracket and interconnected to form a connection point.

4. The artificial valve device as described in claim 3, characterized in that, Each of the shoulder sleeves is connected to the bracket at least on the link at the connection point, and the shoulder sleeve is folded onto the body around the connection point.

5. The artificial valve device as described in claim 1, characterized in that, In a cross-section along the central axis of the artificial valve device, the rotator cuff is triangular, quadrilateral, or arc-shaped.

6. The artificial valve device as described in claim 5, characterized in that, The shoulder sleeve is shaped like a right triangle, with one vertical side of the right triangle coinciding with at least a portion of the first or second side of the body, the other vertical side of the right triangle being perpendicular to the first or second side, and the angle between the hypotenuse of the right triangle and the first or second side being in the range of 20° to 70°.

7. The artificial valve device as described in claim 1, characterized in that, Multiple cross-sections are formed between the multiple links of the stent, and the first side and the second side of the main body are respectively sutured to the multiple cross-sections along the axial direction of the artificial valve device.

8. The artificial valve device as described in claim 1, characterized in that, The number of at least two lobes corresponds to the number of at least two skirts.

9. The artificial valve device as described in any one of claims 1-8, characterized in that, The skirt is made of elastic polymer material or elastic biomaterial.

10. The artificial valve device according to any one of claims 1-8, characterized in that, The skirt and the support are connected by stitching.

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