CN115737210A - Prosthetic valve device - Google Patents

Abstract

The present disclosure provides a prosthetic valve device comprising a stent comprising a plurality of links; at least two leaflets, each leaflet including a base fixed relative to the stent and an opposite free end; and at least two skirt rims, each skirt rim comprising a body extending axially and circumferentially of the prosthetic valve device, and two cuffs extending from circumferentially opposite first and second sides of the body, respectively, wherein 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 via at least the cuffs, respectively. The prosthetic valve device of the present disclosure sutures the leaflets to the skirt, which is then sutured to the stent, such that the skirt acts as a cushioning component between the leaflets and the stent, cushioning the pull on the leaflets, thereby preventing them from being damaged or mechanically failing in this region when the leaflets close.

Description

artificial valve device

technical field

The present disclosure relates to an artificial valve device, in particular to an artificial valve device with an improved connection method.

Background technique

Heart valves are an important part of the heart. During the working process of the heart, the heart valves are constantly opened and closed to achieve normal blood circulation. When the valves are mutated due to congenital or acquired diseases, the valves cannot be opened and closed normally. It will have a significant impact on human health and life. In this case, treatment can be done by replacing the artificial heart valve.

At present, the artificial heart valves mainly used are mainly divided into surgical implantation type and transcatheter intervention type according to the characteristics of the implanted human body. At present, most existing interventional valves are composed of a stent, leaflets and skirts, wherein both the leaflets and the skirt are sutured to the stent by sutures. After the valve is implanted, the implanted valve leaflet is used to replace the diseased native valve leaflet, while the implanted skirt is used to improve the paravalvular leakage after valve implantation. In existing products, since the leaflet is directly sewn with the stent or other metal parts on the stent, when the leaflet is closed, the leaflet directly pulls the stent or its metal parts, and there is no stress buffer between the leaflet and the metal, which makes Stress concentrates on the leaflets whose mechanical strength is much lower than that of metal materials, which makes the leaflets prone to mechanical failure, such as leaflet tearing, leaflet damage, etc., which in turn leads to serious consequences of functional failure of the entire artificial heart valve.

Therefore, it is desired to provide an improved artificial valve device for the above-mentioned deficiencies in the prior art.

Contents of the invention

The present disclosure provides an artificial valve device, which includes a stent, at least two leaflets and at least two skirts. The stent includes a plurality of connecting rods, 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 and a circumferentially extending main body, and two rotator cuffs extending from first and second circumferentially opposite sides of the main body, respectively. Wherein, the top side of the main body is connected to one of the at least two leaflets, and the first side and the second side of the main body are respectively connected to the bracket via the rotator cuff.

In one embodiment, the top side of the main body includes an arc-shaped edge, the bottom edges of 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, and the leaflets are connected to the bottom edges of the at least two leaflets. The brackets are not directly attached.

In one embodiment, the arc-shaped edges of at least two main bodies are arc-shaped concave toward the main body, and the top ends of the arc-shaped edges of adjacent main bodies are respectively connected with the brackets and connected with each other to form connection points.

In one embodiment, each rotator cuff is attached to the frame at least at the link where the attachment point is located, and the rotator cuff is folded over the body around the attachment point.

In one embodiment, on a section along the central axis of the artificial valve device, the shape of the rotator cuff is triangular, quadrangular or arcuate.

In one embodiment, the rotator cuff is in the shape of a right triangle, one vertical side of the right triangle coincides with at least a portion of the first side or the second side of the main body, and the other vertical side of the right triangle coincides with the first side or the second side vertical, and the included angle between the hypotenuse of the right triangle and the first side or the second side is within the range of 20°-70°.

In one embodiment, a plurality of intersections are formed between the plurality of connecting rods of the stent, and the first side and the second side of the main body are respectively sewn to the plurality of intersections along the axial direction of the artificial valve device.

In one embodiment, the number of at least two leaflets corresponds to the number of at least two skirts.

In one embodiment, the skirt is made of elastic polymer material or elastic biomaterial.

In one embodiment, the skirt and the leaflet are connected by suture; the skirt and the bracket are connected by suture.

According to the artificial valve device of the embodiment of the present disclosure, by suturing the leaflet to the skirt, and then suturing the skirt to the stent, the skirt acts as a buffer assembly between the leaflet and the stent, which can buffer the pulling of the leaflet role in order to avoid damage or mechanical failure of the leaflets in this area when the leaflets close. In addition, after the skirt is sewn to the frame, the rotator cuffs of the skirt are folded over the main body and sewn to the frame, thereby attaching a reinforced area with increased thickness at the connection point, which reinforces the strength at the connection point, It also makes the area flat and easy to crimp for easy handling.

Description of drawings

Embodiments of the present disclosure are further described below by way of example with reference to the accompanying drawings, which constitute a part of this specification, and in the accompanying drawings:

1A and 1B are front views of a prosthetic valve device according to an exemplary embodiment;

2A is an elevational view of a skirt and leaflets in a prosthetic valve device when not mounted to a stent, according to an exemplary embodiment.

Figures 2B and 2C are front views of the skirt in Figure 2A;

3A and 3B are another front views of a prosthetic valve device according to an exemplary embodiment;

Detailed ways

Those skilled in the art will understand further features, advantages and effects of the present disclosure more clearly and thoroughly through the following further detailed description of the embodiments of the present disclosure in conjunction with the accompanying drawings and specific implementation methods. In the following descriptions, spaces and orientations such as "top", "bottom", "front", "rear", "left", "right", "top", "bottom", "vertical" and "horizontal" may be used Terms are used to describe the embodiments of the present disclosure, but it should be understood that these terms are used merely for convenience in describing the embodiments shown in the figures and do not require that the actual device be constructed or operate in a particular orientation. In the following description, the use of terms such as "connected", "coupled", "fixed" and "attached" may mean that two elements or structures are directly connected with no other elements or structures in between, or that two The individual elements or structures are indirectly connected through intervening elements or structures, unless expressly stated otherwise herein. The use of ordinal numerals, such as "first", "second", etc., are only used to distinguish the elements they refer to from each other and do not have a sense of order or priority unless explicitly stated otherwise herein.

The basic structure of a prosthetic valve device 100 according to an exemplary embodiment is first described with reference to FIG. 1A . As shown, the prosthetic valve device 100 according to the exemplary embodiment includes a skirt 110 , leaflets 120 and a stent 130 . The bracket 130 is a substantially cylindrical structure composed of a plurality of links, and a plurality of intersections are formed between the links. In some embodiments, the connecting rod can be made of materials such as superelastic alloy or shape memory alloy, so that the prosthetic valve device 100 provided with the stent 130 can shrink and expand radially. In some embodiments, the prosthetic valve device 100 may include a plurality of valve leaflets 120, for example two (for the case of the mitral valve) or three (such as for the case of the aortic valve or the tricuspid valve, as shown in Fig. 1A, and Figure 3A). And in some embodiments, the number of skirts 110 may correspond to the number of leaflets 120 . FIG. 1B shows the suturing method among the skirt 110 , leaflet 120 and stent 130 in FIG. 1A , which will be described in detail below.

Next, in conjunction with the schematic diagrams of FIGS. 2A to 2C , the basic structure, connection relationship and principle of the skirt 110 and leaflets 120 in the artificial valve device 100 according to an exemplary embodiment will be described in detail, so as to facilitate the understanding of the entire artificial valve device. 100 for further understanding. 2A-2C are front views of a skirt and leaflets in a prosthetic valve device when not mounted to a stent, according to an exemplary embodiment. From the perspective of the front view of the valve leaflet 120, the valve leaflet 120 arranged above is half-moon-shaped, and the bottom edge 122 of the valve leaflet 120 is arc-shaped, while from the front view of the artificial valve device 100, the valve leaflet 120 The bottom edge 122 of the leaflet 120 is fixed relative to the support 130, and the leaflet 120 also has a free end opposite to the bottom edge 122. According to actual needs, in various embodiments, the leaflet 120 may be, for example, an aortic valve, a pulmonary valve, a mitral valve, a tricuspid valve, etc., and may be made of artificial materials or biological tissues.

The skirt 110 is arranged below the valve leaflet 120 to prevent paravalvular leakage. The structure of the skirt 110 is shown in FIGS. and two rotator cuffs 114 extending from the left side 112-2 and the right side 112-3 of the main body 112, respectively (the area of the rotator cuffs 114 is indicated by a triangle in FIG. 2C). It should be noted that the number and position of the skirt generally correspond to the number and position of the valve leaflets, and each skirt has two rotator cuffs. Specifically, if the valve is an aortic valve or a tricuspid valve (as shown in Figure 1A and 3A), the number of rotator cuffs is 6. In addition, only one or two skirts facing the observer are shown in Fig. 1A and Fig. 3A, and the view of the skirt on the other side away from the observer is not given. The left side 112 - 2 and the right side 112 - 3 of the main body 112 are respectively connected to the bracket 130 , and the connection method will be described in detail below. The top side 112 - 1 of the body 112 is connected to the leaflet 120 . Specifically, the top side 112 - 1 of the main body 112 includes an arc-shaped edge, the arc-shaped edge is a concave arc toward the direction of the main body 112 , and the corresponding arc-shaped bottom edge 122 of the leaflet 120 is passed through a suture 142 stitched together. Wherein, both ends of the top side 112 - 1 of the main body 112 are connected with the leaflet 120 to form a vertex. The position of the suture 142 in the artificial valve device 100 is shown in FIG. 1B . In addition, the top ends of the arc-shaped edges of adjacent main bodies 112 are respectively connected to the brackets 130 and connected to each other to form the connection points 124 . It should be noted that, referring to FIG. 1A to FIG. 2A , the skirt 110 is connected to the bottom edge of the leaflet 120 , so that the leaflet 120 is not directly connected to the stent. 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 the interference of the stent during the movement of the leaflet 120 on the one hand, enhances the mobility of the leaflet, and avoids the phenomenon of incomplete closure of the leaflet; The buffer between the stents reduces the stress on the leaflets, reduces the possibility of mechanical failure of the leaflets and the connection with the skirt and the stents, thereby prolonging the life of the leaflets. In addition, it can be seen from FIG. 1B that the rotator cuffs 114 on both sides of the main body 112 are connected with the frame 130 and folded on the main body 112 to form a reinforced area 132 . The details of the reinforced area will be specifically described below.

With continued reference to FIGS. 2A-2C , in various embodiments, the rotator cuff 114 or body 112 may have different shapes. According to actual needs, on a section along the central axis of the artificial valve device 100 , the shape of the rotator cuff 114 may include a triangle, a quadrangle or an arc. In the embodiment shown in the present disclosure, each rotator cuff 114 is shaped as a right triangle when viewed from a front view, one vertical side of which is aligned with either the left side 112-2 or the right side 112-3 of the main body 112. At least part of coincides, and its other vertical side is perpendicular to the left side 112-2 or right side 112-3 of the main body 112, and its hypotenuse is to the left side 112-2 or the right side 112-3 of the main body 112 between The included angle is, for example, in the range of 20° to 70°. In some embodiments, the skirt 110 may be an integral part made of elastic polymer material or elastic biomaterial. It should be noted that "at least two skirts" herein also includes the case where the at least two skirts are integrally formed cylindrical skirts. In one embodiment, each of the cylindrical skirts The skirt has two rotator cuffs, so it has at least 4 rotator cuffs. Specifically, if the valve is aortic or tricuspid (as shown in Figure 1A and Figure 3A), the number of rotator cuffs is six. The elastic polymer material is, for example, silicone rubber, polyurethane, and the like. Elastic biomaterials are, for example, bovine pericardium and porcine pericardium tissue. It should be noted that the division of the skirt 110 into the main body 112 and the rotator cuff 114 in the present disclosure is only for functional considerations and convenience of description, and is used to divide the left side 112 of the boundary line between the main body 112 and the rotator cuff 114 -2 or right side 112-3 is also only schematic and will be described in more detail below.

In addition, it should be emphasized again that in the above and below descriptions, although the terms "upper", "lower", "left", "right", "top", "bottom", "vertical" and " "horizontal" and other space and orientation terms, but these terms are only for the convenience of describing the embodiments shown in the figures, those skilled in the art can understand that when changing the direction of the devices or components in the embodiments, these corresponding terms Obviously something should change accordingly.

Next, a prosthetic valve device 100 according to an exemplary embodiment will be described with reference to FIGS. 3A and 3B to further explain the principles and advantages of the present disclosure. As mentioned above, the prosthetic valve device 100 is suitable for tricuspid valves. As can be seen more clearly in FIG. 3B , the top side 112 - 1 of the main body 112 of the skirt 110 and the top of the rotator cuff 114 are sutured together with the bottom edge of the leaflet 120 by sutures 142 , respectively. The left side 112 - 2 and the right side 112 - 3 of the main body 112 can be longitudinally sutured to multiple intersections between multiple connecting rods of the bracket 130 via sutures 144 along the axial direction of the artificial valve device 100 . It should be noted that the leaflet 120 according to the embodiment of the present disclosure is directly connected with the skirt 110 instead of the bracket 130 . The artificial valve device in this embodiment avoids the interference of the stent during the movement of the leaflet 120 on the one hand, enhances the mobility of the leaflet, and avoids the phenomenon of incomplete closure of the leaflet; The buffer between the stent and the stent reduces the stress on the leaflet, reduces the possibility of mechanical failure of the leaflet and the connection with the skirt and the stent, thereby prolonging the life of the leaflet. In addition, it should also be understood that the sewing method of the skirt 110 and the bracket 130 can be arbitrary, and the sewing method along the longitudinal suture line in the present disclosure is only one of them, and can be stitched at multiple positions on the bracket according to actual needs. The skirt and the bracket are stitched at the place to better fix the skirt. Additionally, it can also be seen more easily here that the left side 112-2 of the body 112 of one skirt 110 defined in FIG. 2B and the right side 112-3 of the body 112 of an adjacent skirt 110 are defined in FIG. The longitudinal sutures 144 are shown joining or overlapping. In other words, to the left of the seam 144 is the right side 112-3 of one skirt 110 and to the right of the seam is the left side 112-2 of the (adjacent) other skirt 110 . In other words, the specific position of the left side 112 - 2 or the right side 112 - 3 is actually defined for the position of the above-mentioned suture line 144 , so it is not just a geometric definition. In other embodiments, the main bodies 112 of three or more skirts 110 are arranged along the circumferential direction of the artificial valve device 100 and stitched together, which is not limited in the present invention.

How to fix the skirt 110 and leaflet 120 on the bracket 130 will be described in detail below with reference to FIGS. 1A to 3B . In traditional artificial valve devices, the leaflets and skirts of the valve are directly sutured and connected to the stent, so when the leaflets are closed, the leaflets directly pull the stent, causing the stent to directly transfer the stress to the leaflet in reverse, and the valve Leaflets are prone to mechanical failure, such as leaflet tearing, leaflet damage, etc. In an embodiment according to the present disclosure, the leaflets 120 are first sutured to the skirt 110, including to the body 112 and at the apex, and then the skirt 110 is sutured to the frame 130 with the rotator cuffs 114 facing inwardly on both sides. The respective main body 112 is folded and finally the rotator cuff 114 is sewn to the link near the connection point 124 . It needs to be explained again that the “vertex” herein refers to the junction between the two ends of the top side 112 - 1 of the main body 112 and the leaflet 120 . The design of directly suturing the leaflet 120 to the skirt 110 makes the leaflet 120 and the bracket 130 not directly connected, so the bracket 130 will not directly transmit stress to the leaflet 120, thus avoiding the direct sewing of the leaflet in the prior art Various problems associated with attaching to brackets. Specifically, in the region of the arc-shaped base 122 of the leaflet 120 as shown in FIG. 2A , the skirt 110 acts as a buffer assembly between the leaflet 120 and the bracket 130, avoiding the pulling of the leaflet to the bracket. Pulling buffers the reverse stress of the stent on the leaflets, so that when the leaflets are closed, the leaflets are prevented from being damaged in this area and resulting in mechanical failure. In addition, using the elastic skirt 110 as a component connecting the leaflet 120 and the bracket 130 can also enhance the mobility of the leaflet 120 itself. Therefore, without changing the size of the valve leaflet, the stronger mobility ensures that the valve leaflet has enough margin in the movement after implantation to be completely closed, so as to better prevent regurgitation after implantation. In order to better realize the above-mentioned technical effects, the polymer material or biological material used to make the skirt should have excellent elasticity, tensile resistance and biological safety. It should be noted that, when the rotator cuff 114 has not been sewn onto the bracket 130, its shape is shown in FIG. 2A, and the hypotenuse of the triangular-shaped rotator cuff 114 is free to extend. And when the rotator cuff 114 is sewn onto the support 130, as mentioned above, the two adjacent rotator cuffs 114 of the adjacent skirt 110 are sewn together axially, and the free ends of the rotator cuff 114 extend radially inward. , so the rotator cuff 114 in FIG. 3B looks different from the outwardly facing rotator cuff 114 in FIG. 2A.

The prosthetic valve device 100 according to an exemplary embodiment will be described below with reference to FIGS. 3A and 3B to illustrate further advantages of the prosthetic valve device, especially the function of the rotator cuff 114 of the skirt 110 . As previously described in connection with FIG. 2C , two rotator cuffs 114 extend from the left side 112 - 2 and the right side 112 - 3 of the main body 112 respectively, and the rotator cuffs 114 have a right triangle shape in the illustrated embodiment, adjacent The top ends of the arc-shaped edges of the main body 112 are respectively connected to the brackets 130 and connected to each other to form the connection points 124 (ie, the positions circled in the figure). It should be noted that the connection point area of the traditional artificial valve device is the place where multiple valve leaflets are connected in pairs and are directly connected with the stent. The connection point is the position where the stress is relatively concentrated, and the stress in this area is the largest. If the strength at the connection point is insufficient, most of the valves will mechanically fail here, or the stress carried by the stent is directly transmitted from the connection point to the valve leaflet, further leading to mechanical failure of the valve leaflet.

To alleviate this problem, after first suturing the leaflets 120 to the skirt 110 and then suturing the skirt 110 to the frame 130 by the suturing operations described above, the rotator cuffs 114 are folded towards the respective main body 112, and then the The rotator cuff 114 is stitched to the rod near the attachment point 124 in the manner shown in FIGS. 1B and 3B . Thus, by folding the rotator cuff 114 over the main body 112 , a reinforced region 132 of increased thickness is formed below the connection point 124 . In an alternative embodiment, the reinforced area 132 may be located at a position different from that shown in the figure by changing the shape of the rotator cuff and its stitching position, for example, the reinforced area 132 may cover the connecting point 124 . The reinforced area 132 not only strengthens the connection point 124, but also makes this area flat and easy to crimp, thereby facilitating handling. It should be noted that the reinforced area 132 is the area where the folded rotator cuffs are located after sewing, specifically, the reinforced area is mainly composed of overlapping stitched skirts, and is folded through the rotator cuffs 114 of the skirt 110 according to an embodiment of the present disclosure. On the main body 112, a reinforcement area is formed near the connection point 124, thereby enhancing the reinforcement performance at the connection point 124, and improving the problem that the traditional leaflet is prone to failure at the connection point. It should be noted that, as shown above, the rotator cuff can be in other shapes, and the fixing effect of the skirt and the bracket can be adjusted by changing the size of the reinforced area.

In a word, the artificial valve device of the present disclosure uses the special suturing of the leaflets and the skirt, and the skirt and the stent, so that the leaflets are not directly sewed and fixed with the stent. Specifically, by suturing the leaflet to the skirt and then suturing the skirt to the stent, the skirt acts as a cushioning component between the leaflet and the stent, which can buffer the pulling effect on the leaflet, so that the leaflet When closed, damage or mechanical failure of the leaflets in this area is avoided. That is, all areas that may transmit stress or cause traction to the valve leaflets are buffered by the skirt. In addition, by using the elastic skirt as a component connecting the leaflet and the bracket, the mobility of the leaflet itself can also be enhanced, thereby ensuring the movement of the leaflet after implantation without changing the size of the leaflet. There is enough margin for full closure to better prevent regurgitation after implantation. Further, after the skirt is sewn to the bracket, the rotator cuff of the skirt is folded on the main body and sewn to the bracket, thereby forming a reinforcement area with increased thickness near the connection point, and the reinforcement area strengthens the strength at the connection point, Relief of stress concentrations at the connection point also makes this area flat and easy to crimp for easy handling.

Although the present disclosure has been described with reference to the foregoing embodiments, it will be understood by those skilled in the art that various changes may be made without departing from the spirit and scope of the present disclosure as defined in the appended claims. While this specification contains many specific implementation details, these should not be construed as limitations on the scope of what this disclosure claims, but rather as descriptions of features specific to particular embodiments. The scope of the present disclosure is defined by the appended claims and their equivalents, and not limited to the foregoing described embodiments.

Claims (10)

1. A kind of artificial valve device, is characterized in that, comprises a bracket including a plurality of linkages; at least two leaflets, each of said leaflets comprising a base fixed relative to said frame and opposite free ends; and At least two skirts, each skirt comprising a main body extending axially and circumferentially along the prosthetic valve device, and two respectively extending from the upper circumferentially opposite first and second sides of the main body Rotator cuff, where: The top side of the body is connected to one of the at least two leaflets, and the first side and the second side of the body are connected to the frame at least respectively via the rotator cuff. 2. artificial valve device as claimed in claim 1, is characterized in that, the top side of described main body comprises arc-shaped edge, and the bottom edge of described at least two leaflets is arc-shaped, and all of at least two described main bodies The arc-shaped edges are respectively connected to the bottom edges of the at least two leaflets, and the leaflets are not directly connected to the bracket. 3. The prosthetic valve device according to claim 2, wherein the arc-shaped edges of at least two of the main bodies are concave arcs toward the direction of the main bodies, and the arcs adjacent to the main bodies are The top ends of the shaped edges are respectively connected with the supports and connected with each other to form connection points. 4. The artificial valve device according to claim 3, wherein each of the rotator cuffs is connected to the bracket at least on the connecting rod where the connection point is located, and the rotator cuff is folded on the on the body around the connection point. 5. The artificial valve device according to claim 1, characterized in that, on a section along the central axis of the artificial valve device, the shape of the rotator cuff is triangular, quadrangular or arc-shaped. 6. The artificial valve device as claimed in claim 5, wherein the shape of the rotator cuff is a right triangle, and a vertical side of the right triangle is connected to the first side or the second side of the main body. At least a part of the side coincides, the other vertical side of the right triangle is perpendicular to the first side or the second side, and the hypotenuse of the right triangle is perpendicular to the first side or the second side The angle between them is in the range of 20°～70°. 7. The artificial valve device according to claim 1, wherein a plurality of intersections are formed between the plurality of connecting rods of the bracket, the first side of the main body and the second The sides are respectively sutured to the plurality of intersections along the axial direction of the artificial valve device. 8. The artificial valve device according to claim 1, wherein the number of the at least two leaflets corresponds to the number of the at least two skirts. 9. The artificial valve device according to any one of claims 1-8, wherein the skirt is made of elastic polymer material or elastic biological material. 10. The artificial valve device according to any one of claims 1-8, characterized in that, the skirt is connected with the valve leaflet by suture; the skirt is connected with the support by suture connect.

Images