WO2023284663A1

WO2023284663A1 - Valve stent, valve prosthesis and valve prosthesis system

Info

Publication number: WO2023284663A1
Application number: PCT/CN2022/104819
Authority: WO
Inventors: 王广卉; 黎鹏; 谢建
Original assignee: 上海易桥医疗器械有限公司
Priority date: 2021-07-12
Filing date: 2022-07-11
Publication date: 2023-01-19
Also published as: CN113499168A

Abstract

A valve stent, a valve prosthesis (100) and a valve prosthesis system. The valve stent comprises: a stent body (10), comprising an inner stent (12) and a plurality of first stents (112), wherein the plurality of first stents (112) are located on the outer periphery of the inner stent (12), and outflow ends of the plurality of first stents (112) are connected to the inner stent (12), and inflow ends are movable ends; and a connector (30), wherein the movable ends are movably connected to the connector (30), so that the first stents (112) and the connector (30) have a first positional relationship and a second positional relationship; when the first stents (112) and the connector (30) have the first positional relationship, the plurality of first stents (112) are in a retracted position, and when the first stents (112) and the connector (30) have the second positional relationship, the first stents (112) are in an expanded position. The valve stent will not excessively strain the first stents (112) thereof to break or shorten the fatigue life of the first stents (112).

Description

Valve stents, valve prostheses and valve prosthesis systems

technical field

The disclosure relates to the technical field of medical devices, in particular to a valve support, a valve prosthesis and a valve prosthesis system.

Background technique

The mitral valve is a valve in the heart that separates the left atrium from the left ventricle. The mitral valve acts as a "one-way valve" that allows blood to flow in one direction by opening or closing. Under normal circumstances, the mitral valve allows blood to flow from the left atrium to the left ventricle, but if the mitral valve is incompetent, when the heart contracts, part of the blood flow will return to the left atrium, which is "mitral regurgitation". Mitral regurgitation puts an increased load on the heart, lungs, and other organs. In some patients, the heart must contract and relax harder to pump blood throughout the body, resulting in an enlarged heart. As the condition gradually worsens, other more serious heart problems will eventually appear, such as total heart failure, which may lead to irregular heartbeat, cerebral hemorrhage, and even sudden death.

In recent years, with the progress of minimally invasive interventional therapy technology, transcatheter artificial heart valve replacement has been rapidly developed and applied clinically. This technology implants an artificial heart valve into the original mitral valve of the heart through interventional surgery to replace the original mitral valve and restore its original function. The interventional operation does not require thoracotomy, with less trauma and quick postoperative recovery. It provides a new treatment method for those patients with high surgical risks, which can prolong the life of patients. At present, the upper end of most valve prosthesis, that is, the inflow end of the valve prosthesis (from which blood flows into the valve prosthesis), is an open structure and is not connected as a whole. The nodes of the open structure are relatively sharp, which may cause damage to the attached tissue after the valve prosthesis is implanted in the body.

In the related art, in order to prevent the nodes of the open structure from causing damage to the adjoining tissue, the nodes of the inflow end of the valve prosthesis are connected together to form a rounded closed structure to avoid damage to the adjoining tissue. However, during the delivery process, the valvular prosthesis needs to be crimped to a very small delivery size as a whole, and bound in the lumen of a delivery tube of a few millimeters. In the crimping process, the fixed connection of the inflow end will restrict the stent rod of the valve prosthesis, hindering the crimping of the stent rod. In addition, after the crimping is completed, the upper end of the support rod is in a bent state, and the strain at this part is very large, which may exceed the elastic deformation range that the support rod material can withstand, which often easily causes the support rod to break or shorten the fatigue of the support rod life.

Contents of the invention

The present disclosure aims to solve at least one of the technical problems existing in the prior art. To this end, the present disclosure proposes a valve stent. By providing connectors at the movable ends of a plurality of first stents, the first stents are movably connected to the connectors, so that the first stents can be smoothly expanded or contracted without The strain of the first support is too large to break or shorten the fatigue life of the first support.

The present disclosure also proposes a valve prosthesis comprising the above-mentioned valve support.

The present disclosure also proposes a valve prosthesis system including the above valve prosthesis.

The valve stent according to the embodiment of the first aspect of the present disclosure includes: a stent body, the stent body includes an inner stent and a plurality of first stents, the plurality of first stents are located on the outer periphery of the inner stent and along the inner The circumferential distribution of the brackets, the outflow ends of a plurality of the first brackets are connected to the inner brackets, the inflow ends of the first brackets are movable ends; and the connectors, the movable ends of the first brackets are movable connected with the connector so that the first bracket has a first positional relationship and a second positional relationship with the connector; when the first bracket has a first positional relationship with the connector, a plurality of The first support is in the contracted position, and in the contracted position, the valve support is in a cylindrical shape; when the first support has a second positional relationship with the connector, the first support is in a A deployed position, in which the first support protrudes outward in the radial direction of the valve support.

According to some embodiments of the present disclosure, the connector has an active slot, and the active ends of the plurality of first brackets are movably disposed in the active slot.

According to some embodiments of the present disclosure, the connector further has a first avoidance groove, and the first escape groove communicates with the movable groove, and the first bracket also has a main body part and is arranged between the main body part and the active groove. The connecting portion between the movable ends is located in the first avoidance groove when the plurality of first brackets are in the retracted position.

According to some embodiments of the present disclosure, the width of the active slot is greater than the width of the active end, the width of the active end is greater than the width of the connecting part; and/or the active slot is configured as a spherical slot, and the first The avoidance groove is configured as a rectangular groove, and the movable end is configured as a sphere or disc; and/or the first avoidance groove is configured as a rectangular groove, and the depth of the rectangular groove is greater than or equal to that of the first bracket. The thickness of the connecting portion, the width of the rectangular slot is greater than or equal to the width of the connecting portion of the first bracket.

According to some embodiments of the present disclosure, the connector includes a connection seat and a cover body, the movable groove and the first avoidance groove are formed on the connection seat, the cover body is arranged on the connection seat and partially Cover the movable slot; and/or the connector includes a connecting base and a cover, the connecting base and the cover are provided with a threaded shaft hole, the shaft hole of the connecting base is connected to the cover The shaft holes of the shafts are aligned with each other, so that the connecting seat and the cover can detachably cooperate with the conveying part of the conveying assembly.

According to some embodiments of the present disclosure, a second avoidance groove is formed on the cover body, and the second avoidance groove is arranged opposite to the first avoidance groove. When a plurality of the first brackets are in the unfolded position , the connecting portion is located in the second avoidance groove.

According to some embodiments of the present disclosure, the length of the second escape groove is not less than the length of the first escape groove, and the width of the second escape groove is not smaller than the width of the first escape groove.

According to some embodiments of the present disclosure, each of the first brackets includes: a first rod segment, and one end of the first rod segment of a plurality of the first brackets is movably connected to the connector, so that The one end of the first rod segment is the movable end, the number of the first rod segments is n, and the n satisfies the relational formula: 3≤n≤15, and a plurality of the first brackets are connected in sequence, wherein , each of the first brackets also includes a second rod segment, the other end of each of the first rod segments is connected with at least two second rod segments, and the second rod segments of the plurality of first brackets The rod segments are sequentially connected in the circumferential direction; or, each of the first brackets further includes two second rod segments and a transition rod segment, and the other end of each of the first rod segments is connected by the transition rod segment There are at least two second rod sections, and a plurality of transition rod sections of the first bracket are sequentially connected in the circumferential direction.

The valve prosthesis according to the embodiment of the second aspect of the present disclosure includes: the valve stent according to the embodiment of the first aspect of the present disclosure; the leaflet, the leaflet is fixed to the inner support; and the skirt, the The skirt covers the inner surface and/or the outer surface of the stent body.

The valve prosthesis system according to the embodiment of the third aspect of the present disclosure includes: the above-mentioned valve prosthesis and delivery assembly, the delivery assembly includes: a delivery sheath and a guide wire, a delivery lumen is arranged in the delivery sheath, the The delivery chamber is used to load and deliver the valve prosthesis.

Additional aspects and advantages of the disclosure will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the disclosure.

Description of drawings

The above and/or additional aspects and advantages of the present disclosure will become apparent and comprehensible from the description of the embodiments in conjunction with the following drawings, in which:

1 is a schematic diagram of a valve prosthesis (connector omitted) implanted in the left atrium according to an embodiment of the present disclosure;

2 is a schematic structural view of a valve prosthesis according to an embodiment of the present disclosure;

Figure 3 is a top view of a valve prosthesis (leaflets and skirts omitted) according to an embodiment of the present disclosure;

4 is a schematic structural view of a valve stent according to an embodiment of the present disclosure;

Fig. 5 is a schematic structural view of an inner stent according to an embodiment of the present disclosure;

Fig. 6 is a structural schematic diagram of the first stent in a compressed position according to an embodiment of the present disclosure;

Fig. 7 is a schematic structural diagram of the first stent in a deployed position according to an embodiment of the present disclosure;

8 is a cross-sectional view of a connector according to an embodiment of the present disclosure;

9 is a cross-sectional view of a connection seat according to an embodiment of the present disclosure;

Fig. 10 is a bottom view of a connecting seat according to an embodiment of the present disclosure;

11 is a cross-sectional view of a cover according to an embodiment of the present disclosure;

12 is a schematic diagram of a valve prosthesis contracted according to an embodiment of the present disclosure;

13 is a schematic diagram of a valve prosthesis just implanted in the right atrium according to an embodiment of the present disclosure;

14 is a schematic illustration of a valve prosthesis from the left atrium and annulus centered into the left ventricle according to an embodiment of the present disclosure.

Reference signs:

100. Valve prosthesis;

10. The main body of the bracket;

11. Outer bracket; 111. Atrial matching part; 112. First bracket; 113. First rod segment; 114. Transition rod segment; 115. Second rod segment; 116. Valve annulus matching part; 117. Second rod ; 118, the third pole section; 119, the fourth pole section;

12. Inner support; 121. Grid frame; 122. Fifth rod segment; 123. Sixth rod segment; 124. Leaflet connecting segment;

22. skirt; 23. valve ring; 24. atrial wall; 25. left atrium;

30. Connector; 31. Movable groove; 32. First escape groove; 33. Connecting seat; 34. Cover body; 35. Second avoidance groove; 36. Shaft hole;

210, delivery sheath; 220, guide wire.

detailed description

Embodiments of the present disclosure are described in detail below, examples of which are illustrated in the accompanying drawings, wherein the same or similar reference numerals designate the same or similar elements or elements having the same or similar functions throughout. The embodiments described below by referring to the figures are exemplary only for explaining the present disclosure and should not be construed as limiting the present disclosure.

The following describes a valve support and a valve prosthesis 100 according to an embodiment of the present disclosure with reference to FIGS. 1-14 , and the present disclosure also proposes a valve prosthesis system having the above-mentioned valve prosthesis 100 .

The valve prosthesis 100 of the present disclosure can be used to replace native valve structures such as mitral valve, tricuspid valve, aortic valve, and pulmonary valve, and the replacement of mitral valve will be described below as an example.

As shown in FIGS. 1-5 , a valve prosthesis 100 according to an embodiment of the present disclosure includes a valve stent, and the valve stent includes a stent body 10 and a connector 30 . The stent body 10 includes an outer stent 11 and an inner stent 12 , the outer stent 11 is connected to the inner stent 12 and is located on the outer periphery of the inner stent 12 . Optionally, the valve prosthesis 100 may also include leaflets and a skirt 22, the leaflets are fixed to the inner stent 12, the skirt 22 covers the inner surface and/or outer surface of the stent main body 10, and the connector 30 is arranged on the outer stent 11 top. Wherein, "the top of the outer stent 11" refers to the inflow end of the outer stent 11, that is, the blood flows in from the inflow end.

Wherein, the stent body 10 is the main structure of the valvular prosthesis 100, the inner stent 12 can provide support for the leaflets, and at least one of the outer stent 11 and the inner stent 12 can provide support for the skirt 22, and the outer stent 11 can realize Installation, positioning and fixation of the valve prosthesis 100 within the left atrium 25 and at the annulus 23 of the native mitral valve. In addition, the outer stent 11 and the inner stent 12 can be manufactured in an integrated manner, such as integral cutting of pipe material or integral weaving of wire material, and then shaped into the stent main body 10 through heat treatment process. The outer bracket 11 and the inner bracket 12 can also be processed separately, and the outer bracket 11 and the inner bracket 12 are processed separately, and then the parts are connected by welding and/or riveting to form an integral bracket body 10 .

The skirt 22 is used to realize the sealing function, to ensure that the passage of blood flowing into the left ventricle from the left atrium 25 is only the passage after the leaflets are opened, so as to prevent blood from leaking from the periphery of the valve prosthesis 100 or from the inside of the valve prosthesis 100, affecting Hemodynamic Effects of Valve Prosthesis 100 .

The skirt 22 can be made from animal-derived pericardial tissue, or made from biocompatible polymers, such as polyethylene terephthalate, polytetrafluoroethylene or expanded polytetrafluoroethylene. By suturing, the skirt 22 is stitched together with the stent body 10 and the leaflets to prevent blood from leaking from the gaps in the grid of the stent body 10 and the gap between the outer stent 11 and the inner stent 12, thereby ensuring good blood flow dynamics. At the same time, the surface of the skirt 22 has a microporous structure, which is conducive to the crawling of human endothelial cells, can accelerate the endothelialization of the valve prosthesis 100, is beneficial to the long-term fixation of the valve prosthesis 100, and can also improve the thrombus situation of the valve prosthesis 100 . Optionally, the skirt 22 can also be attached to the stent body 10 by heat fusion.

In the embodiment of the present disclosure, the skirt 22 may cover the outer surface of the outer stent 11 and the inner surface of the inner stent 12 to prevent blood leakage. That is, by arranging the skirt 22 on the outer surface of the outer stent 11 and the inner surface of the inner stent 12, it is possible to prevent blood from leaking from the outer stent 11, the inner stent 12, and the gap between the outer stent 11 and the inner stent 12, and affecting the intervention valve. The hemodynamic effect of the prosthesis 100 ensures that the passage of blood from the left atrium 25 into the left ventricle is only the passage after the leaflets are opened.

The leaflets can simulate the original leaflets, close when the left ventricle contracts, and open when the left ventricle diastoles, replacing the function of the original leaflets. Optionally, the leaflets are prepared from animal-derived pericardium tissue, preferably porcine pericardium and bovine pericardium tissue, and are sutured to the stent main body 10 after inactivation and anti-calcification processes. Optionally, the valve leaflets are prepared from animal-derived valve tissues, such as porcine aortic valves, porcine pulmonary valves, and the like. Optionally, the leaflets are made of biocompatible polymers, such as polyethylene terephthalate, polytetrafluoroethylene, polyethylene, etc., and their processing is more difficult than that of animal-derived tissues. Simple, and the production and preparation methods are also more convenient.

In the embodiment of the present disclosure, the leaflets are of a leaf-like structure, and the three leaflets are sutured to the inner support 12 using a suturing process. The three leaflets cooperate with each other and have good hydrodynamic effects, so that the hemodynamics are more stable when the leaflets open and close. Optionally, there may be two valve leaflets, which is the same number as that of the native mitral valve. Alternatively, the leaflets can also be 4 or more, which can be set according to actual needs. In addition to suturing, the leaflets can also be fixed on the inner frame 12 in other ways, for example, bonding or welding.

Wherein, as shown in FIG. 3 and FIG. 4 , the outer bracket 11 includes a plurality of first brackets 112, and the plurality of first brackets 112 are located on the outer periphery of the inner bracket 12 and are distributed along the circumferential direction of the inner bracket 12. For example, preferably, a plurality of The first brackets 112 may be sequentially connected along the circumferential direction. Outflow ends of the plurality of first stents 112 (that is, blood flows out from the outflow ends) are connected to the inner stent 12 . For example, the plurality of first stents 112 may be part of the atrial matching portion 111 . For example, the atrium matching part 111 has a plurality of first stents 112 extending axially. Circumferential direction) distribution, when the atrium matching part 111 is stretched, the first strut protrudes outward toward the radial direction of the valve prosthesis 100 to form a spherical or spherical-like space to match the heart chamber of the left atrium 25 The shapes are matched, so that the atrial matching part 111 is supported on the atrial wall 24 in a spherical or spherical-like form, so as to realize the fixation of the valve prosthesis 100 in the left atrium 25 . Specifically, the spherical or spherical atrium matching part 111 cooperates with the atrium wall 24, and the two resist each other, which can ensure that the atrial matching part 111 is effectively attached to and supported on the atrial wall 24 when the heart beats, avoiding valve prosthesis The valve prosthesis 100 is moved and displaced along the front-back, left-right, and up-down directions, so that the valve prosthesis 100 is reliably fixed in the left atrium 25 . The plurality of first brackets 112 may be two, three or four first brackets.

For example, the axial direction of each first stent 112 is arranged along the axial extension of the valve prosthesis 100 , and a plurality of first stents 112 are distributed in the circumferential direction of the valve prosthesis 100 . For example, the plurality of first stents 112 are distributed at intervals in the circumferential direction of the valve prosthesis 100 , preferably at even intervals. Furthermore, the plurality of first stents 112 are sequentially connected along the circumferential direction of the inner stent 12 (in other words, along the circumferential direction of the valve prosthesis 100). For example, the first support 112 includes first struts and connecting struts, and the plurality of first struts of the plurality of first supports 112 are distributed at intervals in the circumferential direction of the valve prosthesis 100, preferably distributed at uniform intervals, and the plurality of first supports 112 are distributed at regular intervals. A plurality of connecting struts of a stent 112 are sequentially connected in the circumferential direction of the valve prosthesis 100, so that each first strut is connected with two adjacent first stents 112 in the circumferential direction through a corresponding connecting strut to form a spherical Or a spherical atrium matching part 111 . A plurality of first brackets 112 abut against the atrial wall 24 and rely on the support of the atrial wall 24 to prevent the valve prosthesis 100 from moving in front, back, left and right, and up and down directions, so that the valve prosthesis 100 is reliably fixed in the left atrium 25 . Wherein, the number of the first brackets 112 may be between 3-15, and the preferred embodiment of the present disclosure is 6.

The inflow ends of the plurality of first brackets 112 are movable ends, and the movable ends of the first brackets 112 are movably connected to the connector 30 so that the first brackets 112 and the connector 30 have a first positional relationship and a second positional relationship. Specifically, the first positional relationship means that the connector 30 is parallel to the axial direction of the first bracket 112, and the second positional relationship means that the connector 30 and the axial direction of the first bracket 112 have a certain angle, for example, the angle is at 0 to a range of 90°. Specifically, when the first brackets 112 have a first positional relationship with the connector 30, the plurality of first brackets 112 are in a retracted position, and in the retracted position, the valve bracket is in a cylindrical shape. When the first bracket 112 has the second positional relationship with the connector 30, the first bracket 112 is in the deployed position, and in the deployed position, the first bracket 112 protrudes outward in the radial direction of the valve bracket.

For example, a plurality of first stents 112 are used to move between the retracted position and the expanded position, specifically, when the plurality of first stents 112 are in the retracted position, the valve stent (and the valve prosthesis 100) is in a cylindrical shape; When the plurality of first stents 112 are in the deployed position, the plurality of first stents 112 protrude outward in the radial direction of the valve stent (and the valve prosthesis 100 ). The inflow ends of the plurality of first stents 112 constitute the inflow end of the atrium matching portion 111 , such as the top as shown in FIGS. 2 and 4 , that is, the top of the outer stent 11 . The inflow end of the first bracket 112 is a movable end, and the connectors 30 are disposed on the movable ends of the plurality of first brackets 112 , in other words, the connector 30 is movably connected to the movable ends of the plurality of first brackets 112 . When the plurality of first supports 112 move between the retracted position and the deployed position, the movable ends of the plurality of first supports 112 move relative to the connector 30, thereby facilitating the movement of the plurality of first supports 112 between the retracted position and the deployed position. Activity. As shown in FIG. 12 , when the plurality of first stents 112 are in the retracted position, the part between the inflow end and the outflow end of the first stent 112 (that is, opposite to the inflow end, the blood flows out from the outflow end) is adjacent to the inner stent 12 , the radial dimension of the valve prosthesis 100 is small at this time, and the valve prosthesis is cylindrical (wherein, the valve support including the stent main body 10 and the connector 30 is also cylindrical), which is convenient to be packed into the delivery sheath, and delivered The sheath is delivered to the left atrium 25; as shown in Fig. 1, Fig. 2 and Fig. 4, when a plurality of first stents 112 are in the expanded position, a plurality of first stents 112 are in the diameter of the valve prosthesis 100 (or valve stent) Protrude outward in the direction. At this time, the part between the inflow end and the outflow end of the plurality of first stents 112 is away from the inner stent 12, and the plurality of first stents 112 are spherical or spheroidal, which can facilitate the artificial valve. Body 100 is supported within left atrium 25 . That is to say, the connection form between the connector 30 and the first bracket 112 is a multi-directional movable form, that is, after the first bracket 112 is combined with the connector 30, the movable end of the first bracket 112 can move relative to the connector 30, so that The plurality of first supports 112 smoothly move between the deployed position and the contracted position relative to the connector 30 , which facilitates the change of the shape of the valve prosthesis 100 (or valve support) without causing damage to the first supports 112 . In this way, the connector 30 will not affect the contraction and deployment of the first bracket 112 , and will not cause excessive strain of the first bracket 112 to break or affect the fatigue life when the first bracket 112 is in the retracted position. In addition, the open inflow ends of the multiple first stents 112 are connected by the connector 30 to form a closed structure, which prevents the open inflow ends of the multiple first stents 112 from causing damage to the atrial wall 24 .

Wherein, when the first support 112 is in the retracted position, the whole valve prosthesis 100 (or valve support) is constrained into a cylindrical state, and the plurality of first supports 112 are close to each other. Extending in the axial direction of , and the plurality of first brackets 112 are still connected as a whole through the connector 30 . And, when the first brackets 112 are in the unfolded position, the multiple first brackets 112 are far away from each other, and at this moment, the multiple first brackets 112 are still connected as a whole through the connector 30 .

Thus, by setting the connector 30 at the inflow end of the first bracket 112, that is, the movable end, and the movable end can move relative to the connector 30, so that a plurality of first brackets 112 can smoothly move between the retracted position and the expanded position, In this way, the first bracket 112 can be expanded or contracted smoothly, and the strain of the first bracket 112 will not be too large to break or affect the fatigue life after the compression is completed.

Referring to FIGS. 6-9 , the connector 30 is formed with a movable slot 31 , and a plurality of first brackets 112 are movably disposed in the movable slot 31 . It should be noted that “a plurality of first brackets 112 are movably arranged in the movable slot 31” here specifically refers to that the movable ends of the plurality of first brackets 112 can be positioned in the movable slot 31 relative to the movable slot 31 And/or angle changes, for example, the movable end can be displaced and/or angularly deflected (including rotating) in the movable groove 31 relative to the movable groove 31 .

For example, the connector 30 is provided with an active slot 31, a plurality of first brackets 112 can extend into the active slot 31, and the active end can move up and down relative to the active slot 31 and in the radial direction of the valve prosthesis 100. outward or inward movement on the The "up and down direction" here refers to the axial direction of the valve prosthesis 100, wherein "upward" movement refers to the movement from the outflow end of the valve prosthesis 100 to the inflow end direction, and "downward" movement refers to Movement in the direction from the inflow end to the outflow end of the valve prosthesis 100 . For example, when the valvular prosthesis 100 is to be delivered, the valvular prosthesis 100 can be switched from the expanded position to the retracted position, at this time, the movable end of the first support 112 can be upward in the active groove 31 and the radial direction of the valvular prosthesis 100 The valve prosthesis 100 is conveniently constrained into a cylindrical state by moving inward in the direction, that is, the valve prosthesis 100 is in a contracted position, and the outer stent 11 and the inner stent 12 are in close contact at this time. When in the retracted position, the inflow end of the first support 112 is close to the vertical state in the movable groove 31, that is, the inflow end of the first support 112 is parallel or nearly parallel to the axial direction of the movable groove 31 of the connector 300, as shown in Figure 6 As shown, at this time, the inflow end of the first bracket 112 extends along a straight line, that is, there is no need to forcibly bend the end of the first bracket 112 , so that excessive strain of the first bracket 112 will not cause fracture or affect fatigue life. Wherein, the axial direction of the connector 300 is consistent with the axial direction of the valve prosthesis 100 . For another example, when a plurality of first stents 112 are switched from the retracted position to the deployed position, the movable end of the first stent 112 is compressed toward the outflow end along the axial direction of the valve prosthesis 100, and at the same time, the middle part of the first stent 112 is moved toward the valve The radial direction of the prosthesis 100 protrudes outward, so as to facilitate the outward deformation of the first stent 112 in the radial direction of the valve prosthesis 100 for deployment. For another example, when a plurality of first stents 112 are switched from the expanded position to the contracted position, the movable end of the first stent 112 extends along the axial direction of the valve prosthesis 100 toward the inflow end. Compared with the deployed position, the middle of the first stent 112 Partially toward radial contraction of the valve prosthesis 100, the first stent 112 deforms inwardly to contract.

Or, in other embodiments, a pivot pin (not shown) may be arranged in the movable groove 31, and the pivot pin is connected to two inner walls of the movable groove 31 opposite in the circumferential direction of the connector 30, the second The movable end of a support 112 is provided with perforation (figure not shown), and the movable end of the first support 112 can be sleeved on the shaft pin through the perforation, so that the movable end of the first support 112 can rotate around the shaft pin to facilitate The first stand 112 smoothly switches between the retracted position and the deployed position. In this way, when the valve prosthesis 100 is switched from the expanded position to the contracted position, the end of the first stent 112 does not need to be forcibly bent, thereby preventing the first stent 112 from breaking due to excessive strain or affecting the fatigue life.

After the valve prosthesis 100 is implanted into the left atrium 25, as shown in FIG. The inflow end of the connector 30 is close to a horizontal state in the movable groove 31. Due to the beating of the heart, the atrial wall 24 will squeeze the valve prosthesis 100 in all directions. At this time, the first bracket 112 will be deformed under force, so that the shape of the inflow end of the first bracket 112 changes, and the connector 30 The structure of the movable groove 31 provided inside can adapt to various deformations of the first bracket 112, such as inward contraction deformation, outward expansion deformation, etc., to ensure that the movable end is always inside the connector 30 (specifically, always in the movable groove 31) , and the cooperation between the movable end of the first bracket 112 and the connector 30 is a movable fit, that is, the movable end of the first bracket 112 can move in the connector 30 instead of being fixedly constrained in the connector 30, so that when the bracket When the main body 10 is deformed due to the beating of the heart, the first bracket 112 will not be overly constrained by the connector 30 to cause greater deformation. In this way, the connector 30 enables the first stent 112 to deform in response to the external force when the first stent 112 is serving in the left atrium 25, and there is no stress concentration at the joint between the first stent 112 and the connector 30, and the first stent 112 is less likely to be deformed. Micro-crack fracture can significantly improve the fatigue performance of the stent main body 10 . In addition, the inflow end of the first stent 112 cooperates with the connector 30 to form a closed structure, which can prevent the atrial wall 24 from being damaged by the inflow end of the first stent 112 in an open structure state. It can be understood that the "closed structure" described here means that the inflow end of the first bracket 112 fits in the movable groove of the connector 30, so that the inflow end of the first bracket 112 is connected in the connector 30, thereby providing Non-exposed state; on the contrary, the "open structure" described here refers to the situation in the prior art, that is, the inflow end of the first bracket 112 is not located in the connector, so it is in an exposed state.

6-10, the connector 30 is also formed with a first avoidance groove 32, the first avoidance groove 32 communicates with the movable groove 31, and when the plurality of first brackets 112 are in the contracted position, the first brackets 112 are adjacent to each other. The connecting portion of the movable end is located in the first escape groove 32 . The rod body portion of the first bracket 112 adjacent to the movable end is a connecting portion connecting the movable end and the main body of the first bracket 112 . That is to say, when the first bracket 112 is in the retracted position, the connecting parts of the plurality of first brackets 112 are accommodated in the first escape groove 32, so that the radial dimension of the bracket body 10 can be reduced when the first bracket 112 is in the retracted position. , to facilitate the delivery of the stent main body 10 . Specifically, when the first bracket 112 is in the retracted position, the movable end of the first bracket 112 can be accommodated in the movable groove 31, and the connecting portion of the first bracket 112 is located in the first escape groove 32, and the first bracket 112 can be Stands vertically without deformation.

Certainly, the first escape groove 32 may not be provided. For example, in the case where the active groove 31 is provided and the first escape groove 32 is not provided, the active groove 31 may be provided with an open side facing downward and outward in the radial direction of the valve prosthesis 100 . This can also ensure that the plurality of first brackets 112 are close to each other when the first brackets 112 are in the retracted position, reducing the radial dimension of the bracket body 10 when the first brackets 112 are in the retracted position.

Wherein, the width of the movable groove 31 is larger than the width of the movable end, and the width of the movable end is larger than the width of the connecting portion. That is to say, the outer dimensions of the movable end are smaller than the outer dimensions of the movable groove 31, so that the movable end can be turned up and down, left and right in the movable groove 31, so as to adapt to the deflection force received when the stent main body 10 is in service in the left atrium 25 , and it is convenient for the first bracket 112 to switch between the contracted position and the expanded position. And, the width of the movable end is greater than the width of the connecting portion, so that when the movable end is set in the movable groove 31, the movable end will not disengage from the opening of the movable groove 31, so that the connector 30 can be arranged rationally.

Referring to Figures 6-9, the movable groove 31 is configured as a spherical groove, cylindrical groove or ellipsoidal groove, and the movable end is configured as a sphere or disc. Wherein, the movable groove 31 is set as a spherical groove, so that the movable end can be turned over smoothly (that is, angularly deflected) in the movable groove 31, for example, the movement in the vertical direction and the outward movement in the radial direction of the valve prosthesis 100 occur. Or the inward movement facilitates the shape change of the outer support 11. And, the movable end is configured as a sphere or disc, which also allows the movable end to move up and down in the movable groove 31 and to move outward or inward in the radial direction of the valve prosthesis 100, so as to adapt to When the stent main body 10 is serving in the heart cavity, it is subjected to deflection forces in all directions. Among them, the movable end is preferably in the shape of a disc, which is convenient for processing and forming, and is also convenient for installation.

In addition, as shown in FIG. 8 and FIG. 9 , the first avoidance groove 32 is configured as a rectangular groove, and the rectangular groove can facilitate the accommodation of the connecting portion of the first bracket 112 in the first avoidance groove 32 . And, the depth of the rectangular groove just matches (that is, is equal to) the thickness of the connecting portion of the first bracket 112, or is greater than the thickness of the connecting portion of the first bracket 112, and the width of the rectangular groove should be greater than or equal to the connecting portion of the first bracket 112 width, when the first bracket 112 is in the retracted position, the connection part of the first bracket 112 can be just accommodated in the rectangular groove, so that the first bracket 112 can be in a vertical state without deformation, and the external dimension will not exceed The size of the connector 30 will not affect the use of the connector 30, nor will it increase the radial size of the valve prosthesis 100 additionally. It can be understood that the "depth" of the rectangular groove refers to the dimension of the rectangular groove in the radial direction of the connector 30, and the "width" of the rectangular groove refers to the dimension of the rectangular groove in the circumferential direction of the connector 30. size of. The "thickness" of the connection part refers to the dimension of the connection part in the radial direction of the connector 30 when it is housed in the rectangular groove, and the "width" of the connection part means the dimension of the connection part when it is housed in the rectangular groove. Dimensions in the circumferential direction of the connector 30 .

6, the connector 30 includes a connecting seat 33 and a cover 34, the movable groove 31 and the first escape groove 32 are formed on the connecting seat 33, the cover 34 is arranged on the connecting seat 33, and the cover 34 partially covers the movable Groove 31. That is to say, the connector 30 is composed of a cover body 34 and a connecting seat 33, and the connecting seat 33 is provided with a movable groove 31 matched with the first bracket 112, which can be used to accommodate the movable end of the first bracket 112 and allow the movable The end moves in the movable groove 31. The main function of the cover body 34 is to fasten to the outside of the connecting seat 33 to prevent the first bracket 112 from falling out when moving in the connecting seat 33 , that is, to limit the freedom of movement of the first bracket 112 . When assembling, first put the movable end of the first bracket 112 into the movable groove 31, and then fasten the cover body 34 on the connecting seat 33 to prevent the movable end from slipping out of the movable groove 31, so that the lid body 34 and The connection seat 33 can form an effective and reliable movable connection structure.

The connection seat 33 and the cover body 34 can be made of nickel-titanium alloy, cobalt-chromium alloy, titanium alloy, stainless steel or polyetheretherketone with good biocompatibility and good processability. The connecting seat 33 and the cover body 34 can be made of the same material or different materials. Preferably, the connecting base 33 and the cover 34 are made of the same material. The connection form of the connecting seat 33 and the cover body 34 can be selected from methods such as welding, bonding or threaded connection.

In addition, as shown in Fig. 6, Fig. 8 and Fig. 11, a second avoidance groove 35 is formed on the cover body 34, and the second escape groove 35 is arranged opposite to the first escape groove 32, and the second escape groove 35 and the movable groove 31 In communication, when the plurality of first brackets 112 are in the unfolded position, the connecting portion of the first brackets 112 is located in the second escape groove 35 . Wherein, when the first bracket 112 is in the unfolded position, the connection portions of the plurality of first brackets 112 are arranged nearly horizontally, and the second avoidance groove 35 is set on the cover body 34, which can allow the connection portions of the first bracket 112 to escape from the second avoidance groove. The groove 35 protrudes into the connector 30 , and cooperates with the connector 30 through the movable end, so that the first bracket 112 can be unfolded smoothly, and the first bracket 112 can be prevented from slipping out of the connector 30 . Wherein, the length and width of the second escape groove 35 should not be smaller than the length and width of the first escape groove 32 , so that the connecting part of the first bracket 112 can move flexibly in the second escape groove 35 and the first escape groove 32 . It can be understood that the “length” of the second relief groove 35 refers to the dimension of the second relief groove 35 in the axial direction of the cover body 34 .

As shown in FIGS. 8-11 , the connecting seat 33 and the cover body 34 are provided with a threaded shaft hole 36 . As shown in FIG. 8 , the shaft hole 36 of the connecting base 33 and the shaft hole 36 of the cover 34 are aligned with each other. By setting the shaft hole 36 on the connection seat 33 and the cover body 34 and the shaft hole 36 of the connection seat 33 and the shaft hole 36 of the cover body 34 are aligned with each other, so that the connection seat 33 and the cover body 34 can be connected with the delivery parts of the delivery assembly. Detachably fit. Specifically, when the delivery element is connected with the connector 30, the valve prosthesis 100 can be pushed out of the delivery sheath. After implantation is complete, the delivery member is detached from the connector 30 so that the delivery assembly can be withdrawn from the left atrium 25 . Wherein, other detachable connection methods may also be provided between the connector 30 and the conveying member. For example, clamping, that is, the connector 30 and the delivery part are provided with a slot and a buckle. During implantation, the connector 30 and the delivery part are snapped and fitted. After the implantation is completed, the connector 30 and the delivery part are cancelled. Snap-in between parts.

Further, as shown in FIG. 8 , the shaft hole 36 of the connecting seat 33 is a through hole penetrating through the connecting seat 33 . Furthermore, as shown in FIG. 9 , the shaft hole 36 of the connecting seat 33 passes through the connecting seat 33 in the axial direction of the connecting seat 33 and is located at the center of the connecting seat 33 . Similarly, as shown in FIG. 8 and FIG. 9 , the shaft hole 36 of the cover body 34 is a through hole passing through the cover body 34 , and further, the shaft hole 36 of the cover body 34 penetrates the cover body in the axial direction of the cover body 34 body 34 and is located at the center of the cover body 34 . With such arrangement, the shaft hole 36 of the connecting base 33 can be easily aligned with the shaft hole 36 of the cover body 34 .

As shown in FIGS. 1 and 4 , the stent body 10 further includes an annulus matching portion 116 disposed at the lower end of the atrium matching portion 111 . The annulus matching part 116 is matched with the annulus 23 of the native mitral valve, specifically, the annulus matching part 116 is inserted in the valve annulus 23, relying on the radial support force of the annulus matching part 116, the valve prosthesis 100 The positioning of the valve prosthesis 100 is prevented from deflecting. In this way, in combination with the foregoing, the valve prosthesis 100 is basically located in the cardiac cavity of the left atrium 25, and the valve prosthesis 100 is fixed in the left atrium 25 by relying on the mutual resistance of the atrium matching part 111 and the atrium wall 24, which can Avoid twisting and shifting when the heart beats. At the same time, the annulus matching part 116 cooperates with the valve annulus 23 and the native leaflets, and the valve prosthesis 100 is supported on the valve annulus 23 by virtue of the radial support force of the valve annulus matching part 116, further avoiding the deflection and displacement of the valve prosthesis 100. bit. In this way, the valve prosthesis 100 relies on two kinds of fixation mechanisms through the design of the two shapes of the outer stent 11 to achieve reliable fixation after implantation.

As shown in FIG. 4 , each first bracket 112 includes: a first rod segment 113 and at least two second rod segments 115 . The upper end of the first rod section 113 of each first bracket 112 is arranged close to each other to form the top of the atrium matching part 111, that is, the upper end of the first rod section 113 is the movable end of the first bracket 112, and the first rod section 113 is close to it. The part of the rod at the upper end is the connecting part of the first bracket 112 . At least two second rod segments 115 are connected to the lower end of each first rod segment 113 , and the second rod segments 115 of the plurality of first brackets 112 are sequentially connected in the circumferential direction. That is to say, each first rod segment 113 is connected with at least two second rod segments 115 , and two adjacent second rod segments 115 are connected in the circumferential direction.

Wherein, the number of the first rod segments 113 is consistent with the number of the first brackets 112 , that is, the number of the first rod segments 113 is 3-15, and the number of the first rod segments 113 is 6 in the embodiment of the present disclosure. In addition, the rod width of the first rod segment 113 is the largest in the whole bracket body 10, and the rod width d1 of the first rod segment 113 is designed to be 0.3-5 mm. Optionally, the rod width d1 of the first rod segment 113 is designed to be 0.5 mm to 3 mm. By rationally designing the number and width of the first rod segments 113, the number of the first rod segments 113 and the width of the rods cooperate and cooperate with each other, so that the valve prosthesis 100 has sufficient rigidity in the expanded position and sufficient rigidity in the retracted position. Have sufficient flexibility.

Specifically, when the valve prosthesis 100 is in the deployed position, the number of the first rod segments 113 will not be too small, so that the outer stent 11 can form a spherical or spherical-like support in the left atrium 25, and, as shown in FIG. The number of one rod segment 113 will not be too much, that is, the first rod segment 113 is relatively sparse overall, which can prevent the endothelialized valve prosthesis 100 from blocking the pulmonary vein and affecting the blood flow path of the pulmonary vein. In addition, during the suturing process of the valve leaflet, the sparse first rod section 113 less shields the suturing operation, which facilitates the needle thread to pass through the sparse first rod section 113 to suture the valve leaflet and the inner frame 12 . Further, the first rod segment 113 is provided with an appropriate rod width, so that each first rod segment 113 has a certain rigidity, thereby having a certain supporting force, which can ensure that each first rod segment 113 All are effectively supported on the atrium wall 24, so that the entire valve prosthesis 100 is supported by the atrium wall 24, preventing the valve prosthesis 100 from moving and shifting. "Appropriate bar width" of the first bar section 113 refers to that the bar width of the first bar section 113 can ensure that the first bar section 113 has sufficient rigidity, thus has enough supporting force, and can ensure that it will not Block the suture operation, for example, the rod width is set within 0.5mm-3mm.

As shown in Figures 13 and 14, the valve prosthesis 100 is adapted for delivery into the left atrium 25 through the delivery sheath in the contracted position. When the valve prosthesis 100 is in the retracted position, all the first rod segments 113 merge to form a whole. Under the setting of the rod width of the above-mentioned first rod segment 113, making each first rod segment 113 have a certain rigidity is relative to the contraction and expansion of the atrial wall 24 when the heart beats. In fact, each first rod segment The section 113 can still be bent under a relatively large external force through the rod width designed in the present disclosure. Furthermore, the number of the first rod segments 113 is relatively small, although all the first rod segments 113 are combined to form a rigid stack, but still have a certain degree of flexibility, are easy to be bent, and have good bending performance. In this way, the valvular prosthesis 100 is in the adjustable delivery sheath, and all the first rod segments 113 are combined to form a whole that can be bent, which has little impact on the performance of the adjustable delivery sheath, and facilitates the delivery of the valvular prosthesis 100 The sheath enters the left atrium 25 through the curved blood vessel path and through the interatrial septum, and can avoid damage to the blood vessel wall during delivery. More importantly, by rationally designing the number and width of the first rod segments 113 , the whole formed by combining all the first rod segments 113 has enough flexibility to withstand bending of nearly 90°. As shown in FIG. 14 , the annulus matching portion 116 can be aligned with the valve annulus 23 by bending close to 90°, so that after the valve prosthesis 100 is deployed, the annulus matching portion 116 can be aligned and inserted on the valve annulus 23 superior. It should be noted that after the valve prosthesis 100 is deployed, the outer stent 11 matches the heart chamber of the left atrium 25 , so it is difficult to adjust the position of the valve prosthesis 100 . However, in the present disclosure, when the valve prosthesis 100 is contracted, the first rod section 113 can be bent close to 90° to achieve the centering of the annulus matching part 116, avoiding inaccurate positioning during release, and thus ensuring the annulus matching The part 116 is released in the annulus 23, and the annulus matching part 116 matches with the annulus 23 after being deployed. In addition, after the annulus matching part 116 cooperates with the annulus 23, it can play a positioning role in the installation of the rest of the valve prosthesis 100, ensuring that the valve prosthesis 100 is installed in place. Moreover, the deflection force generated by the first rod section 113 on the annulus 23 is relatively small during the release and deployment process, and once positioned, the valve prosthesis 100 will not be skewed or displaced.

Please refer to FIG. 4 again, the number of the second rod segments 115 is 2 to 6 times that of the first rod segments 113 . In the embodiment of the present disclosure, the number of the second rod segments 115 is 24, which is 4 times the number of the first rod segments 113 , that is, the lower end of each first rod segment 113 is connected with four second rod segments 115 . In addition, the rod width d2 of the second rod segment 115 is 0.1-0.8 mm, and d2<d1. Through the design of the number and width of the second rod segment 115, the position corresponding to the second rod segment 115 is denser and softer, and has better compliance. After the valve prosthesis 100 is implanted, the structure of this segment is consistent with the The lower edge of the atrium wall 24 contacts, and the dense and soft second rod segment 115 has good mechanical properties and shape adaptability, which can ensure that this segment of the stent body 10 is closely attached to the atrium wall 24, and prevent blood from flowing from the stent body 10 to the atrium wall 24. The gap leakage of the atrial wall 24 can effectively reduce the paravalvular leakage, and at the same time, it will not cause excessive support to the atrial wall 24 and affect the systolic function of the atrial wall 24 .

In the embodiment of the present disclosure, in the circumferential direction of the inner bracket 112, in other words, along the circumferential distribution direction of the plurality of first brackets 112, the second rod segments 115 are arranged in one row. It can be understood that the second rod segments 115 It can also be set to 2 rows or 3 rows. But preferably no more than 3 rows, so as not to affect compliance. In addition, the above-mentioned number of second rod segments 115 refers to the number of one row.

Each first bracket 112 further includes: a transition bar segment 114 . The lower end of each first rod segment 113 is connected to at least two second rod segments 115 through a transition rod segment 114, and the transition rod segments 114 are sequentially connected in the circumferential direction. Transitioning and transitioning through the transition bar section 114 can avoid the occurrence of isolated bar sections or nodes, thereby ensuring the closed-loop envelope of the entire outer support 11 . In the embodiment of the present disclosure, the number of transition rod sections 114 is 12. In this way, each first rod section 113 corresponds to two transition rod sections 114, and each of the two transition rod sections 114 corresponds to two second bar segments 115, thereby avoiding isolated bar segments or nodes. The transition rod segment 114 is used as a connecting rod segment between the first rod segment 113 and the second rod segment 115. On the one hand, it needs to have a certain rigidity to ensure better supporting performance; on the other hand, it needs to have a certain It is flexible and can gradually conform to the atrial wall 24 along the direction approaching the second rod segment 115 . Therefore, the rod width d3 of the transition rod section 114 is designed to be 0.2-1 mm, and d1>d3>d2. The number of transition rod sections 114 is adaptively adjusted according to the numbers of the first rod segments 113 and the second rod segments 115 , so as to avoid isolated rod segments or joints.

As shown in FIG. 4 , the height of the annulus matching portion 116 is H, and H satisfies the relationship: 5≤H≤15mm. That is to say, the size of the annulus matching portion 116 in the axial direction is H, and is set between 5-15 mm, so that the annulus matching portion 116 not only cooperates with the annulus 23, but also partially passes through the annulus After 23, it extends into the left ventricle and cooperates with the original leaflet. The annulus matching part 116 partially extends into the left ventricle, which can ensure that when the valve prosthesis 100 is released, the valve annulus matching part 116 first cooperates with the valve annulus 23 to provide a pre-positioning function and prevent the rest of the valve prosthesis 100 from being released. , During the unfolding process, displacement or skew occurs, which affects the final implant effect. After the implantation is completed, the annulus matching part 116 partially protrudes into the left ventricle, which can enhance the fixation effect on the valve prosthesis 100 . In addition, the part of the annulus matching part 116 protruding into the left ventricle can push away the original valve leaflet, restrict the movement of the original valve leaflet, and prevent the movement of the original valve leaflet from interfering with the work of the valve prosthesis 100, for example, avoiding the valve prosthesis 100 Simultaneously working with native leaflets, causing hemodynamic disturbances. In addition, as mentioned above, the valve prosthesis 100 adopts two fixing mechanisms. In the case that the atrial matching part 111 can also play a role in fixing, the valve ring matching part 116 does not need to extend too much into the left ventricle, and the valve prosthesis 100 The main structure of the valve is located in the left atrium 25, and the depth of the annulus matching part 116 extending into the left ventricle is very shallow, which can ensure that the original valve leaflets can be pushed apart, and will not affect the function of the left ventricular outflow tract, and can avoid causing the left ventricular outflow tract. obstruction.

As shown in Figure 4, the annulus matching portion 116 matches the annulus 23, the annulus matching portion 116 is connected to the second rod segment 115, and the annulus matching portion 116 is connected to the inner bracket 12 to form the outer bracket 11 and the inner bracket 12. The connecting section of the inner support 12.

The annulus matching part 116 includes: a plurality of second struts 117 distributed in the circumferential direction. The number of the second struts 117 can be 6-24. The second pole 117 includes: a third pole section 118 and a fourth pole section 119, the third pole section 118 is connected between one end of the second pole section 115 and the fourth pole section 119, and the other end of the fourth pole section 119 Connected to the inner bracket 12 , the third rod segment 118 extends along the axial direction of the inner bracket 12 , and the fourth rod segment 119 extends along the radial direction of the inner bracket 12 . That is to say, after the valve prosthesis 100 is implanted, the third rod segment 118 matches the valve annulus 23, so that the valve prosthesis 100 can be fixed at the valve ring 23, while the outer support 11 and the inner support 12 rely on the fourth rod Section 119 implements a fixed connection. The rod width d4 of the third rod segment 118 is 0.3-0.8 mm, so that the third rod segment 118 has sufficient radial support force, thereby abutting against the annulus 23 .

In the embodiment of the present disclosure, the number of second struts 117 is 12, and a second strut 117 is connected at a node of every two connected second struts 115 . Specifically, the two transition rod segments 114 connected to the same first rod segment 113 extend toward a direction away from each other, and the two second rod segments 115 connected to the same transition rod segment 114 extend toward a direction away from each other. Ends of two adjacent second rod segments 115 on two different transition rod segments 114 are connected, and two adjacent second rod segments 115 are connected with a third rod segment 118 . That is to say, the quantity of the third pole section 118 is half less than that of the second pole section 115, that is, the number of the third pole section 118 is 12, and the number of the fourth pole section 119 is also 12. The segment 118 corresponds to the fourth rod segment 119 one-to-one, the number of the second rods 117 is small, and the distance between them is relatively large, which is beneficial to bending and forming the second rods 117 during the processing of the bracket body 10 to form an L-shaped petal The ring matching part 116 facilitates the connection between the annulus matching part 116 and the inner frame 12 and facilitates the abutment between the valve annulus matching part 116 and the valve annulus 23 .

In addition, the third rod segment 118 is bent relative to the fourth rod segment 119 , and the bending angle θ is set to 90°-180°, but not including 180°, so as to adapt to the annulus 23 . Moreover, the connection between the third rod segment 118 and the fourth rod segment 119 is rounded, so that it can have a round transition, avoid forming sharp bumps, and effectively avoid tissue damage. Preferably, the radius of the fillet is 1mm-2mm.

Referring to FIG. 4 , the sum of the heights of the second rod section 115 and the second support rod 117 is h1, and the height of the inner bracket 12 is h2, and h1 and h2 satisfy the relationship: h1≤h2. Thus, when the valve prosthesis 100 is crimped to the delivery sheath, that is, when the valve prosthesis 100 is in a compressed state, the second rod segment 115 and the second strut 117 overlap with the inner stent 12 . Although the flexibility of each second rod segment 115 is relatively good, the number of the second rod segments 115 is relatively large, and after they are combined into a whole, the rigidities are superimposed to form a rigid part A that is not easy to bend. The inner stent 12 is used to support the valve leaflets, which requires greater rigidity. After the valve prosthesis 100 is compressed, the inner stent 12 will form a rigid part B that is not easy to bend. It should be noted that the inner stent 12 has an appropriate height based on the valve leaflet, that is, the height of the inflexible part B is difficult to adjust. In this way, in order to make the rigid portion of the valve prosthesis 100 in the compressed state relatively minimize in the axial direction and relatively maximize the bendable portion, it is necessary to make the hard-to-bend portion B cover the hard-to-bend portion A in the axial direction, thus, Need to make: h1≤h2.

The outer stent 11 can be prepared by cutting a pipe or braiding a wire. The outer bracket 11 is preferably made of nickel-titanium memory alloy, and shaped into a spherical or spherical-like shape by utilizing its characteristics.

As shown in FIG. 5 , the inner support 12 includes: a plurality of grid frames 121 arranged and connected in an array in the circumferential direction and forming a cylindrical or conical shape. That is to say, the inner frame 12 is a supporting frame composed of a plurality of grid frames 121, and its outline shape is cylindrical or conical. In addition, at least a part of the grid frames 121 are provided with fixing interfaces for fixing the leaflets. The leaflets are sutured through the fixed interface and provide support for the opening and closing movement of the leaflets. Wherein, the grid frame 121 is a quadrilateral structure, and designing the grid frame 121 as a quadrilateral is beneficial to the compression and expansion of the inner support 12 .

Wherein, the inner support 12 includes at least three rows of grid frames 121 in the axial direction. In this embodiment, the inner support 12 includes three rows of grid frames 121 in the axial direction, and each row consists of 12 grid frames distributed in the circumferential direction. 121, it can be understood that in other unshown embodiments, the number of rows of the grid frame 121 and the number of each row can be adjusted according to actual usage requirements.

Further, as shown in FIG. 5 , with the junction of two adjacent grid frames 121 as the boundary, the grid frame 121 includes in the axial direction: a fifth rod segment 122 and a sixth rod segment 123 , specifically In other words, the grid frame 121 is a quadrilateral structure, and designing the grid frame 121 as a quadrilateral is beneficial to the compression and expansion of the inner bracket 12 . Each grid frame 121 includes two sixth pole sections 123 and two fifth pole sections 122 . Since the inner support 12 includes at least three rows of grid frames 121 arranged and connected in an array in the circumferential direction, two adjacent rows of grid frames 121 have a common edge, for example, the grid frames 121 of the first row The sixth pole section 123 is the fifth pole section 122 of the grid frame 121 in the second row. For ease of description and understanding, for a single grid frame 121, the upper one is the fifth rod segment 122, the lower one is the sixth rod segment 123, and the upper ends of the two fifth rod segments 122 are connected to each other. The lower ends of the sixth rod segments 123 are connected to each other, and the lower ends of the fifth rod segments 122 are connected to the upper ends of the corresponding sixth rod segments 123 . The fourth pole section 119 is in one-to-one correspondence with the grid frame 121 in the lowest row, and is connected with the lower ends of the corresponding two sixth pole sections 123 .

As shown in Figure 5, the height of the fifth pole section 122 is h3, the height of the sixth pole section 123 is h4, the height of the second pole section 115 is h5, h3, h4 and h5 satisfy the relationship: h3<h5, h4 <h5. That is to say, the dimensions of the fifth rod segment 122 and the sixth rod segment 123 in the axial direction are smaller than the size of the second rod segment 115 in the axial direction, so as to ensure that the inner support 12 has a higher rigidity, and give the leaflet Sufficient support. In addition, the dimensions of the fifth rod segment 122 and the sixth rod segment 123 in the axial direction can be set to be equal or unequal.

And, the width of the fifth pole section 122 is d5, the width of the sixth pole section 123 is d6, and the width of the second pole section 115 is d2, and d2, d5 and d6 satisfy the relationship: d2<d5, d2<d6. That is to say, the bar width of the fifth bar section 122 and the bar width of the sixth bar section 123 are greater than the bar width of the second bar section 115, so that the inner support 12 formed by the grid frame 121 has better rigidity and strength, and has enough Support the stability of the leaflet movement, avoid the large deformation of the inner support 12 when the leaflet moves, and ensure the normal opening and closing of the leaflet and the hydrodynamic effect. Wherein, the rod width of the fifth rod segment 122 and the rod width of the sixth rod segment 123 may be equal or different, and the rod widths d5 and d6 are both between 0.3mm-1mm.

In addition, as shown in FIG. 5 , the inner bracket 12 is also provided with a leaflet connection section 124 on the side away from the fourth rod segment 119 in the axial direction, and the leaflet is fixed on the leaflet connection section 124 , specifically, the inner bracket 12 The part between the nodes connected by the two fifth rod segments 122 of the grid frame 121 in the first row and the fixed interface is the leaflet connecting segment 124 . The axial dimension of the leaflet connecting section 124 is h6. In this embodiment, the outline shape of the inner stent 12 is cylindrical, and the radial dimension of the inner stent 12 is D1, and h6 satisfies the relational formula: 8mm≤h6≤20mm, D1 Satisfy the relational formula: 21mm≤D1≤34mm. In this way, conforming to the human anatomy and the size of the native valve leaflets, it is convenient for the valve prosthesis 100 to realize the function of the native mitral valve.

The inner stent 12 can be prepared by cutting a pipe, or braiding a wire. The material of the inner stent 12 is preferably a nickel-titanium shape memory alloy, which can be shaped into a corresponding shape by utilizing its characteristics. The material of the inner stent 12 can also be selected from cobalt-chromium alloy, stainless steel, titanium alloy and other materials with good biocompatibility.

The valve prosthesis system according to an embodiment of the present disclosure includes: the above-mentioned valve prosthesis 100 and a delivery assembly, the delivery assembly includes: a delivery sheath 210 and a guide wire 220, a delivery lumen is provided in the delivery sheath 210, and the delivery lumen is used for loading And the valve prosthesis 100 is delivered.

Before the valve prosthesis 100 is implanted, the delivery element (not shown in the figure) is connected to the connector 30 . Then, the valve prosthesis 100 is compressed and gathered, together with the guide wire 220 and the delivery element, and loaded in the delivery cavity. At this time, the plurality of first stents 112 are in the retracted position, and the plurality of first stents 112 are arranged relatively parallel. It can be understood that the delivery lumen can be one lumen or multiple lumens. When the delivery lumen is multiple lumens, the valve prosthesis 100, guide wire 220, delivery parts and other related components can be loaded in different lumens. Inside.

As shown in FIG. 12 and FIG. 14 , firstly, a delivery path from the blood vessel to the left ventricle is established by using the guide wire 220, and the delivery sheath 210 is guided and supported by the guide wire 220, and the valve prosthesis 100 is placed along the guide wire. 220 delivered to the right atrium. Next, the first rod section 113 is bent, so that the valve prosthesis 100 can be extended into the left atrium 25 . Then, after entering the left atrium 25 , the first rod segment 113 is bent again by approximately 90°, so that the valve matching portion 116 is facing the valve ring 23 . Next, the valve prosthesis 100 passes through the valve annulus 23 and partially extends into the left ventricle. Subsequently, the delivery member pushes the valve prosthesis 100 out of the delivery cavity to realize the release of the valve prosthesis 100, and the valve prosthesis 100 expands and expands. Finally, the delivery sheath 210, the delivery member, the guide wire 220 and other related parts of the delivery assembly are taken out.

In describing the present disclosure, it is to be understood that the terms "center", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", The orientations or positional relationships indicated by "top", "bottom", "inner", "outer", etc. are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the present disclosure and simplifying the description, rather than indicating or implying the It should not be construed as limiting the present disclosure that a device or element must have a particular orientation, be constructed, and operate in a particular orientation.

It should be noted that the terms "first" and "second" are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the quantity of indicated technical features. Thus, a feature defined as "first" and "second" may explicitly or implicitly include one or more of these features. Further, in the description of the present disclosure, unless otherwise specified, "plurality" means two or more.

In the description of this specification, references to the terms "one embodiment," "some embodiments," "exemplary embodiments," "example," "specific examples," or "some examples" are intended to mean that the implementation A specific feature, structure, material, or characteristic described by an embodiment or example is included in at least one embodiment or example of the present disclosure. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

Although the embodiments of the present disclosure have been shown and described, those skilled in the art can understand that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principle and spirit of the present disclosure. The scope of the present disclosure is defined by the claims and their equivalents.

Claims

A valve support, is characterized in that, comprises:

The bracket body, the bracket body includes an inner bracket and a plurality of first brackets, the plurality of first brackets are located on the outer periphery of the inner bracket and distributed along the circumferential direction of the inner bracket, and the plurality of first brackets The outflow end is connected to the inner bracket, and the inflow end of the first bracket is an active end; and

a connector, the movable end of the first bracket is movably connected to the connector, so that the first bracket has a first positional relationship and a second positional relationship with the connector;

When the first support and the connector have a first positional relationship, a plurality of the first supports are in the contracted position, and in the contracted position, the valve support is approximately cylindrical; when the first support When a bracket has a second positional relationship with the connector, the first bracket is in a deployed position, and in the deployed position, the first bracket protrudes outward in a radial direction of the valve bracket.
The valve support according to claim 1, wherein the connector has an active slot, and the active ends of the plurality of first supports are movably arranged in the active slot.
The valve support according to claim 2, wherein the connector also has a first avoidance groove, the first avoidance groove communicates with the movable groove, and the first support also has a main body part and a set At the connecting portion between the main body portion and the movable end, when the plurality of first brackets are in the retracted position, the connecting portion is located in the first avoidance groove.
The valve support according to claim 3, wherein the width of the movable groove is greater than the width of the movable end, and the width of the movable end is greater than the width of the connecting part; and/or

The movable groove is configured as a spherical groove, the first escape groove is configured as a rectangular groove, and the movable end is configured as a sphere or disc; and/or

The first avoidance groove is configured as a rectangular groove, the depth of the rectangular groove is greater than or equal to the thickness of the connecting part of the first bracket, and the width of the rectangular groove is greater than or equal to the thickness of the first bracket. The width of the connection.
The valve support according to claim 3, wherein the connector comprises a connecting seat and a cover, the movable groove and the first avoidance groove are formed on the connecting seat, and the cover is arranged on the the connecting seat and partially cover the movable slot; and/or

The connector includes a connecting base and a cover, the connecting base and the cover are provided with threaded shaft holes, the shaft holes of the connecting base and the shaft holes of the cover are aligned with each other, so that The connecting seat and the cover can be detachably matched with the conveying part of the conveying assembly.
The valve stent according to claim 5, wherein a second avoidance groove is formed on the cover body, and the second avoidance groove is arranged opposite to the first avoidance groove. When in the expanded position, the connecting portion is located in the second avoidance groove.
The valve support according to claim 6, wherein the length of the second avoidance groove is not less than the length of the first avoidance groove, and the width of the second avoidance groove is not less than that of the first avoidance groove. width.
The valve stent according to any one of claims 1-7, wherein each of the first stents comprises: a first rod section, a plurality of the first rod sections of the first stent One end is movably connected to the connector, the one end of the first rod segment is the movable end, the number of the first rod segments is n, and the n satisfies the relational formula: 3≤n≤15 ; A plurality of the first brackets are connected in sequence, wherein,

Each of the first brackets also includes a second rod segment, the other end of each of the first rod segments is connected to at least two second rod segments, and the second rods of the plurality of first brackets The segments are sequentially connected in the circumferential direction; or, each of the first brackets also includes two second rod segments and a transition rod segment, and the other end of each of the first rod segments is connected with a transition rod segment through the transition rod segment At least two of the second rod segments, and a plurality of transition rod segments of the first bracket are sequentially connected in the circumferential direction.
A valve prosthesis, characterized in that it comprises:

The valve support according to any one of claims 1-8;

leaflets secured to the inner frame; and

A skirt, the skirt covers the inner surface and/or the outer surface of the stent main body.
A valve prosthesis system comprising:

The valve prosthesis of claim 9; and

The delivery assembly includes: a delivery sheath and a guide wire, and a delivery cavity is arranged in the delivery sheath, and the delivery cavity is used to load and deliver the valve prosthesis.