CN115105264A

CN115105264A - Valve stent and valve prosthesis system

Info

Publication number: CN115105264A
Application number: CN202210809275.4A
Authority: CN
Inventors: 王广卉; 黎鹏; 谢建
Original assignee: Shanghai Yiqiao Medical Instrument Co ltd
Current assignee: Shanghai Yiqiao Medical Instrument Co ltd
Priority date: 2021-07-12
Filing date: 2022-07-11
Publication date: 2022-09-27
Also published as: CN113499167A

Abstract

The invention discloses a valve stent and a valve prosthesis system, wherein the valve stent comprises: an inner stent, a plurality of first stents, and an annulus matching portion; a plurality of the first stents are arranged along the axial extension of the valve stent, the outflow end of the first stent is connected with the outer part of the inner stent through the valve ring matching part, and the plurality of the first stents and the valve ring matching part are arranged along the circumferential direction of the inner stent; a plurality of the first struts forming a space having a spherical or spheroidal shape for supporting an atrium when the first struts are in a deployed state; the valve ring matching part is used for matching with the valve ring. With the arrangement, the first support supports the atrium, so that the valve support can be prevented from shifting along the front-back, left-right and up-down directions during the beating of the heart; the radial supporting force of the valve ring matching part is supported at the valve ring, and the valve prosthesis is further prevented from deflecting and shifting.

Description

Valve stent and valve prosthesis system

Technical Field

The invention relates to the technical field of medical equipment, in particular to a valve stent and a valve prosthesis system.

Background

The mitral valve is a valve in the heart that separates the left atrium and left ventricle. The mitral valve acts as a "one-way valve" that, by opening or closing, ensures that blood flows in one direction. Normally, the mitral valve allows blood to flow from the left atrium to the left ventricle, but if the mitral valve fails to close, some of the blood flow returns to the left atrium upon contraction of the heart, which is "mitral regurgitation". Mitral regurgitation places increased loads on the heart, lungs and other organs, and some patients have enlarged hearts due to the need for more forceful contraction and relaxation of the heart to deliver blood throughout the body. As the condition becomes progressively worse, other more serious heart problems (e.g., total heart failure) eventually occur, and may lead to irregular heartbeats, cerebral hemorrhage, and even sudden death. In recent years, transcatheter prosthetic heart valve replacement has been rapidly developed and applied clinically with the advancement of minimally invasive interventional therapy techniques. The technique implants the prosthetic heart valve into the native mitral valve of the heart through an interventional procedure to replace the native mitral valve and restore the original function. The chest is not needed to be opened in the interventional operation process, the wound is small, the postoperative recovery is fast, a new treatment mode is provided for the patients with high risk in the surgical operation, and the lives of the patients can be prolonged.

However, in the related art, there are some problems: the left heart has large pressure and motion amplitude, and the replaced valve prosthesis is easy to have insufficient matching degree with the atrium and is easy to displace; in addition, the valve prosthesis is too long in structure or too deep into the left ventricle, which affects the function of the left ventricular outflow tract and causes obstruction of the left ventricular outflow tract.

Disclosure of Invention

The present invention is directed to solving at least one of the problems of the prior art. To this end, the invention proposes a valve stent comprising an inner stent, a plurality of first stents and an annulus matching part; the first brackets form a spherical or sphere-like space for supporting the atrium, so that the valve bracket can be prevented from shifting along the front-back, left-right and up-down directions during the beating of the heart, meanwhile, the valve ring matching part is matched with the valve ring, the valve prosthesis is supported at the valve ring by means of the radial supporting force of the valve ring matching part, and the valve prosthesis is further prevented from deflecting and shifting. Through the arrangement of the first bracket and the valve ring matching part, the valve prosthesis can be reliably fixed after being implanted.

The invention also provides a valve prosthesis system.

The valve stent according to an embodiment of the first aspect of the invention comprises: an inner stent, a plurality of first stents, and an annulus matching portion; a plurality of the first stents are arranged along the axial extension of the valve stent, the outflow end of the first stent is connected with the outer part of the inner stent through the valve ring matching part, and the plurality of the first stents and the valve ring matching part are arranged along the circumferential direction of the inner stent; when the first stent is in a deployed state, the middle part of the single first stent is convex outwards in the radial direction of the valve stent along the axial direction of the valve stent; a plurality of the first struts forming a space having a spherical shape or a spheroidal shape for supporting an atrium; the valve ring matching part is used for matching with the valve ring.

According to the valve prosthesis provided by the embodiment of the invention, the first brackets form a spherical or sphere-like space for supporting on the atrial wall, so that the valve prosthesis can be prevented from shifting along the front-back, left-right and up-down directions during the beating of the heart, meanwhile, the valve ring matching part is matched with the valve ring, the valve prosthesis is supported on the valve ring by means of the radial supporting force of the valve ring matching part, and the valve prosthesis is further prevented from deflecting and shifting. Through two fixing mechanisms, the valve prosthesis is reliably fixed after being implanted.

According to some embodiments of the invention, each of the first brackets comprises: a first segment and a second segment, the first segment being closer to the inflow end of the valve stent than the second segment, the inflow ends of the first segments being closer to each other, at least two of the second segments being connected to the outflow end of each of the first segments, one end of the second segments being connected to the first segments, the other end of the second segments being connected to the annulus-mating portion.

According to some embodiments of the invention, each of the first brackets further comprises: a transition pole segment connected between the first pole segment and the second pole segment; the outflow end of each first rod section is connected with at least two transition rod sections, each transition rod section is connected with at least two second rod sections, and/or the number of rows of the transition rod sections is at least one in the circumferential direction of the valve stent.

According to some embodiments of the invention, there are two of said transition segments connected to the same said first segment, the outflow ends of said two transition segments being remote from each other; the two second rod sections connected to the same transition rod section are far away from each other at the outflow ends; and the valve ring matching part is provided with a plurality of third rod sections, and the outflow ends of the second rod sections of the adjacent first brackets are connected to the same third rod.

According to some embodiments of the invention, the first pole segment has a width d1, the second pole segment has a width d2, the transition pole segment has a width d3, and d1, d2 and d3 satisfy the relationship: d1 > d3 > d2, and/or the axial length of the first rod segment is not less than 1/2 of the axial length of the first stent. According to some embodiments of the invention, the annulus matching section comprises: a third segment and a fourth segment, the third segment being connected between the second segment and one end of the fourth segment, the other end of the fourth segment being connected to the inner stent, the third segment being configured to extend in an axial direction of an annulus or being configured to be angled in an axial direction of an annulus; and/or the fourth rod section extends along the radial direction of the inner support, or the fourth rod section and the radial direction of the inner support form an included angle.

According to some embodiments of the invention, the second pole segment has a width d2, the transition pole segment has a width d3, and d1, d2 and d3 satisfy the relationship: d1 > d3 > d 2.

According to some embodiments of the invention, the sum of the heights of the second and third pole segments is h1, the height of the inner armature is h2, and h1 and h2 satisfy the relationship: h1 is less than or equal to h 2.

According to some embodiments of the invention, the inner stent comprises: a plurality of grid frames, taking the junction of two adjacent grid frames as a boundary, the grid frames comprising in the axial direction: a fifth pole segment and a sixth pole segment, the fifth pole segment having a height h3, the sixth pole segment having a height h4, the second pole segment having a height h5, h3, h4 and h5 satisfying the relationship: h3 is more than h5, h4 is more than h 5; and/or the fifth pole segment has a width d5, the sixth pole segment has a width d6, the second pole segment has a width d2, and d3, d4 and d5 satisfy the relation: d2 < d5, d2 < d 6.

According to some embodiments of the invention, the valve annulus mating portion has a dimension H in an axial direction of the valve holder, the H being 0.6 to 2 times an axial dimension of an annulus.

A valve prosthesis system according to an embodiment of the second aspect of the invention, comprising: a valve prosthesis and a delivery assembly, wherein the valve prosthesis comprises the valve support, the valve leaflet and the skirt, the valve leaflet is fixed on the inner support, and the skirt covers the inner surface and/or the outer surface of the valve support; the delivery assembly comprises: the valve prosthesis delivery device comprises a delivery sheath and a guide wire, wherein a delivery cavity is arranged in the delivery sheath and used for loading and delivering the valve prosthesis.

Additional aspects and advantages of the invention 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 invention.

Drawings

The above and/or additional aspects and advantages of the present invention will become apparent and readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings of which:

FIG. 1 is a schematic view of a valve prosthesis according to the present invention implanted in the left atrium;

FIG. 2 is a schematic structural view of a valve prosthesis according to the present invention;

FIG. 3 is a top view of a valve prosthesis according to the present invention;

FIG. 4 is an elevational view of the valve prosthesis according to the invention with the skirt removed;

FIG. 5 is a schematic structural view of a valve stent according to the present invention;

fig. 6 is a schematic structural view of an inner housing according to the present invention;

FIG. 7 is a schematic view of a valve prosthesis according to an embodiment of the present invention just prior to implantation in the right atrium;

fig. 8 is a schematic view of a valve prosthesis according to an embodiment of the invention centered from the left atrium to the annulus into the left ventricle.

Reference numerals:

100. a valve prosthesis;

10. a valve stent;

11. an outer support; 111. an atrium matching section; 112. a first bracket; 113. a first pole segment; 114. a transition rod section; 115. a second pole segment; 116. an annulus matching section; 117. a second support bar; 118. a third pole segment; 119. a fourth pole segment;

12. an inner support; 121. a grid frame; 122. a fifth pole segment; 123. a sixth pole segment; 124. a leaflet attachment section;

21. a leaflet; 22. a skirt edge; 23. an annulus; the atrial wall 24; 25. the left atrium;

210. a delivery sheath; 220. and (6) guiding the wires.

Detailed Description

Embodiments of the present invention will be described in detail below, and the embodiments described with reference to the drawings are exemplary.

Referring now to fig. 1-8, a valve prosthesis 100 according to an embodiment of the present invention is described, and a valve prosthesis system having the valve prosthesis 100 described above is also presented.

The valve prosthesis 100 of the present invention 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 is taken as an example below. The outflow end and the inflow end herein refer to the outflow end and the inflow end of blood.

Referring to fig. 1-5, there is provided a valve prosthesis 100 according to an embodiment of the present invention, the valve prosthesis 100 including: valve support 10, valve leaflets 21 and skirt 22,. The present embodiment also provides a valve stent 10. The valve stent 10 includes: an outer support 11 and an inner support 12, wherein the outer support 11 is connected with the inner support 12 and is positioned at the periphery of the inner support 12.

Wherein, the valve support 10 is the main structure of the valve prosthesis 100, the valve leaflet 21 is fixed on the inner support 12, the valve leaflet 21 is provided with support by the inner support 12, the skirt 22 is coated on the inner surface and/or the outer surface of the valve support 10, the skirt 22 is provided with support by at least one of the outer support 11 and the inner support 12, and in addition, the installation, the positioning and the fixation of the valve prosthesis 100 in the left atrium 25 and the valve ring 23 of the native mitral valve are realized by the outer support 11. In addition, the outer stent 11 and the inner stent 12 can be manufactured by an integrated processing mode, such as integral cutting of a tube or integral weaving of a wire, and then the valve stent 10 is formed by a heat treatment process; or a split processing mode can be selected, the outer support 11 and the inner support 12 are respectively processed, and then the connection of all the parts is realized through welding and/or riveting and the like, so that the integral valve support 10 is formed.

The valve leaflet 21 can simulate the native valve leaflet, and realizes the functions of closing when the left ventricle contracts and opening when the left ventricle relaxes to replace the native valve leaflet. Optionally, the valve leaflet 21 is prepared from animal-derived pericardial tissue, preferably porcine pericardium tissue and bovine pericardial tissue, and is sutured to the valve stent 10 after being subjected to inactivation, calcification resistance and other processes. Optionally, the valve leaflet 21 is prepared from animal-derived valve tissue, such as porcine aortic valve, porcine pulmonary valve, and the like. Optionally, the leaflet 21 is made of a biocompatible polymer, such as polyethylene terephthalate, polytetrafluoroethylene, polyethylene, etc., and the process is simpler than that of animal-derived tissues, and the production and preparation method is more convenient.

As shown in fig. 3 and 4, the leaflet 21 has a blade structure, and 3 leaflets 21 are sutured to the inner frame 12 by a suturing process. The 3 leaflets 21 cooperate with each other to have a good hydrodynamic effect, so that the hemodynamics is more stable when the leaflets 21 open and close. Alternatively, the number of leaflets 21 may be 2, which is the same as the number of leaflets of the native mitral valve. Alternatively, the number of the leaflets 21 can be 4, or more, and the leaflets can be correspondingly arranged according to actual requirements. The leaflets 21 can be secured to the inner stent 12 by other means than sutures, such as adhesive or welding.

The skirt 22 is used to perform a sealing function, ensure that the passage of blood flowing from the left atrium 25 into the left ventricle is only the passage after the valve leaflet 21 is opened, and prevent the blood from leaking from the peripheral side of the valvular prosthesis 100 or from the inside of the valvular prosthesis 100, or from the gaps among the stent mesh gap of the valvular prosthesis 10, the outer stent and the inner stent of the artificial valve leaflet, and affecting the hemodynamic effect of the valvular prosthesis 100.

As shown in fig. 1-3, the skirt 22 covers the outer surface of the outer stent 11 and the inner surface of the inner stent 12 to prevent blood leakage. That is, by disposing the skirt 22 on the outer surface of the outer frame 11 and the inner surface of the inner frame 12, it is possible to prevent blood from leaking from the outer frame 11, the inner frame 12, and the gap between the outer frame 11 and the inner frame 12, which affects the hemodynamic effect of the interventional valve prosthesis 100, and ensure that the passage of blood from the left atrium 25 into the left ventricle is only the passage after the leaflet 21 is opened.

Skirt 22 may be made of animal-derived pericardial tissue or may be made of a biocompatible polymer such as polyethylene terephthalate, polytetrafluoroethylene, or expanded polytetrafluoroethylene. By means of sewing, the skirt 22 is integrally sewn with the valve support 10 and the valve leaflets 21, and blood is prevented from leaking from gaps of meshes of the valve support 10 and gaps between the outer support 11 and the inner support 12, so that good hemodynamics are guaranteed. Meanwhile, the surface of the skirt 22 has a microporous structure, which is beneficial to the climbing of endothelial cells of a human body, 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 condition of the valve prosthesis 100. Alternatively, the skirt 22 can be heat-fused to the valve holder 10.

As shown in fig. 5, the external bolster 11 includes: an atrium mating portion 111, and an annulus mating portion 116 disposed at an outflow end of the atrium mating portion 111. The atrium matching section comprises a plurality of first stents 112, a plurality of the first stents 112 are arranged along the axial extension of the valve stent 12, the outflow end of the first stent 112 is connected to the outside of the inner stent 12 through the annulus matching section 116, and a plurality of the first stents 112 and the annulus matching section 116 are arranged along the circumference of the inner stent 12; when the first stents 112 are in the expanded state, the middle part of the single first stent 112 protrudes outward in the radial direction of the valve stent 10 in the axial direction of the valve stent 12; a plurality of the first stents 112 form a space having a spherical shape or a sphere-like shape to match the shape of the chamber of the left atrium 25 for supporting the atrium, so that the atrium matching section 111 is supported on the atrial wall 24 in a spherical or sphere-like shape, thereby achieving fixation of the valve prosthesis 100 in the left atrium 25. Specifically, the spherical or spheroidal atrium matching portion 111 is matched with the atrium wall 24, and the two portions abut against each other, so that when the heart beats, the atrium matching portion 111 can be effectively abutted and supported on the atrium wall 24, and the valve prosthesis 100 is prevented from shifting along the front-back direction, the left-right direction and the up-down direction, so that the valve prosthesis 100 is reliably fixed in the left atrium 25. Meanwhile, the annulus matching part 116 is matched with the annulus 23 of the native mitral valve, specifically, the annulus matching part 116 is in a circular ring or a similar circular ring structure, the periphery of the annulus matching part 116 abuts against the inner wall of the annulus 23, and the valve prosthesis 100 is positioned by means of the radial supporting force of the annulus matching part 116, so that the valve prosthesis 100 is prevented from deflecting. Thus, when valve prosthesis 100 is positioned in the heart chamber of left atrium 25, valve prosthesis 100 is fixed in left atrium 25 by the abutting action of atrium matching portion 111 and atrial wall 24, and can be prevented from twisting and shifting during beating of the heart. Meanwhile, the valve ring matching part 116 is matched with the valve ring 23 and the native valve leaflets, and the valve prosthesis 100 is supported at the valve ring 23 by means of the radial supporting force of the valve ring matching part 116, so that the valve prosthesis 100 is further prevented from deflecting and shifting. The annulus mating section 116 is also capable of capturing the native leaflets at the periphery of the annulus mating section 116, preventing blood flow at the annulus from being blocked by the native leaflets. In this way, the valve prosthesis 100 can be reliably fixed after implantation by two fixing mechanisms due to the two morphological designs of the plurality of first stents 112 of the outer stent 11 and the valve ring matching part 116.

The atrium matching section 111 includes: a plurality of first supports 112, the plurality of first supports 112 are located on the periphery of the inner support 12 and distributed along the circumferential direction of the inner support 12, for example, preferably, the plurality of first supports 112 may be sequentially connected along the circumferential direction to form a spherical or spheroidal atrium matching part 111, the plurality of first supports 112 abut against the atrial wall 24, and the valvular prosthesis 100 is prevented from moving in the front-back, left-right, and up-down directions by the support of the atrial wall 24, so that the valvular prosthesis 100 is reliably fixed in the left atrium 25. Wherein the number of the first brackets 112 may be between 3 and 15, and 6 in the embodiment of the present invention. It is understood that the plurality of first brackets 112 may be two, three, or four first brackets.

Preferably, each first bracket 112 includes: a first segment 113 and at least two second segments 115, the first segment 113 being closer to the inflow end of the valve stent 10 than the second segment 115, the inflow ends of the first segments 113 being closer to each other, the outflow end of each first segment 113 being connected to at least two second segments 115, one end of the second segment 115 being connected to the first segment 113, the other end of the second segment 115 being connected to the annulus matching portion 116. So configured, compared to the outer stent of the valve stent in the prior art, each first stent 112 in the outer stent of the present embodiment has only one first rod segment 113 near the inflow end, which has three beneficial effects, 1, making the valve stent have a relatively sparse structure on the side near the outflow end. That is, in the upper half of the valve stent near the outflow end, the first stem segment 113 of the first stent 112 is a single strut and is relatively soft. During delivery, the valve stent can be bent by 90 degrees in the blood vessel, so that the possibility of overturning the valve stent during the delivery process is avoided. 2. The first rod segment 113 has a sparse mesh, and in the atrium, the area of the first strut 112 in contact with the atrium is small, and the probability of clogging the vascular opening is small. 3. When the second puncture is performed, the space between the first supports 112 in the atrium is large, the space is large, and the resistance to the second puncture is small. Preferably, the second segments 115 of the plurality of first stents 112 are connected to the segments of the same annulus matching segment 116 to achieve sequential circumferential connection of the first stents 112. That is, each first pole segment 113 is connected with at least two second pole segments 115, and two adjacent second pole segments 115 are connected in the circumferential direction, wherein the number of first pole segments 113 corresponds to the number of first struts 112, i.e., the number of first pole segments 113 is 3-15, preferably 6 in the present embodiment. Preferably, the axial length of the first pole segment 113 is no less than 1/2 of the axial length of the first bracket 112. More preferably, the axial length of the first rod segment 113 is equal to 1/2 of the axial length of the first stent 112, thereby enabling the first rod segment 113 to occupy half of the atrium, thereby further reducing the structure of the valve stent 10 in the atrium. In addition, the rod width of the first rod segment 113 is largest in the entire valve stent 10, and the rod width d1 of the first rod segment 113 is preferably 0.5 to 3mm, for example. The number of first rod segments 113 and the rod width cooperate and cooperate with each other through the number, the rod width and the rod length of the first rod segments 113, so that the valve prosthesis 100 has flexibility capable of supporting the atrium in a deployed state and contractible under the action of the first rod segments 113 and the second rod segments 115 in a contracted state.

Specifically, in the deployed state of valve prosthesis 100, the number of first rod segments 113 is not too small, so that outer stent 11 can be spherically or spherically supported in left atrium 25, and as shown in fig. 1, the number of first rod segments 113 is not too large, that is, first rod segments 113 are sparse as a whole, so that pulmonary veins can be prevented from being blocked after valve prosthesis 100 is endothelialized, and blood flow paths of pulmonary veins can be prevented from being affected. In addition, during the suturing process of the valve leaflet 21, the sparse first rod section 113 has little obstruction to the suturing operation, so that the needle thread can conveniently penetrate through the sparse first rod section 113 to suture the valve leaflet 21 and the inner support 12. Further, the rod width of the first rod segment 113 is larger than that of the second rod segment 113, so that each first rod segment 113 has a certain rigidity and thus has a certain supporting force, and when the heart beats, each first rod segment 113 can be effectively supported on the atrial wall 24, so that the whole valvular prosthesis 100 is supported by the atrial wall 24, and the valvular prosthesis 100 is prevented from moving and shifting.

As shown in fig. 7 and 8, valve prosthesis 100 is adapted to be delivered in a collapsed state through delivery sheath 210 into left atrium 25. In the contracted state of valve prosthesis 100, all of first shaft segments 113 are arranged substantially in the axial direction of valve prosthesis 100 and are combined to form a cylindrical-like structure. With the above-mentioned arrangement of the rod widths of the first rod segments 113, so that each first rod segment 113 has a certain rigidity with respect to the contraction and expansion of the atrial wall 24 during the beating of the heart, in fact, each first rod segment 113 can still be bent under a large external force by the rod width designed by the present invention. Further, the number of the first segments 113 is relatively small, and although all the first segments 113 are combined to form a whole which is rigidly overlapped, the whole has certain flexibility, is easy to bend, and has better bending performance. In this way, the valve prosthesis 100 is in the bendable delivery sheath 210, and the whole formed by combining all the first rod segments 113 can be bent, so that the performance of the bendable delivery sheath 210 is less affected, the valve prosthesis 100 can conveniently enter the left atrium 25 along with the delivery sheath 210 through the bent blood vessel path and through the interatrial septum, and the damage to the blood vessel wall during the delivery process can be avoided. More importantly, by properly designing the number and width of the first pole segments 113, the collective formation of all of the first pole segments 113 is sufficiently flexible to withstand bending of approximately 90. As shown in fig. 8, the annular matching portion 116 can be aligned with the annulus 23 by a bend of approximately 90 °, so that the annular matching portion 116 can be inserted in alignment with the annulus 23 after the valve prosthesis 100 is deployed. It should be noted that after valve prosthesis 100 is deployed, outer stent 11 fits into the heart chamber of left atrium 25, making it difficult to adjust the position of valve prosthesis 100. In the present invention, when the valve prosthesis 100 is in a contracted state, the first rod segment 113 may be bent to approach 90 °, so as to center the annulus matching portion 116, thereby avoiding inaccurate positioning during release, and ensuring that the annulus matching portion 116 is released in the annulus 23, and the annulus matching portion 116 is matched with the annulus 23 after being expanded. In addition, after the valve ring matching part 116 is matched with the valve ring 23, the installation of the rest part of the valve prosthesis 100 can play a positioning role, and the valve prosthesis 100 is ensured to be installed in place. Moreover, the first rod segment 113 generates less deflecting force on the valve annulus 23 during release and deployment, and once positioned, the valve prosthesis 100 does not deflect or shift.

Referring again to fig. 1 and 5, the number of second pole segments 115 is 2-6 times the number of first pole segments 113. In the present embodiment of the invention there are 24, 4 times the number of first pole segments 113, i.e. 4 second pole segments 115 are connected to the other end of each first pole segment 113. In addition, the second pole segment 115 has a pole width d2 of 0.1-0.8mm, and d2 < d 1. Through the design to the quantity of second pole section 115 and pole width for the position department that second pole section 115 corresponds is comparatively dense and soft, has better compliance, after valve prosthesis 100 is implanted, this section structure and the lower edge contact of atrium wall 24, dense and soft second pole section 115 has good mechanical properties and form adaptability, can guarantee that this section of valve support 10 is closely attached to atrium wall 24, avoid blood to leak from the clearance of valve support 10 and atrium wall 24, can effectively reduce the perivalvular leak, simultaneously, also be so far away from leading to the fact excessive support to atrium wall 24, influence atrium wall 24's contractile function.

In the embodiment of the present invention, the second pole segment 115 is arranged in 1 row, and it is understood that the second pole segment 115 can also be arranged in 2 rows or 3 rows. But should not exceed 3 rows in order to avoid compromising compliance. In addition, the number of the second pole segments 115 refers to the number of one line.

Each first bracket 112 further includes: a transition segment 114, the transition segment 114 being connected between the first segment 113 and the second segment 115. The outflow end of each first pole segment 113 is connected to at least two transition pole segments 114, and each transition pole segment is connected to at least two second pole segments 115. Through the transition of the transition pole segment 114, isolated pole segments or nodes can be avoided, thereby ensuring a closed-loop envelope of the entire outrigger 11. In the present embodiment, the number of transition segments 114 is 12, such that each first segment 113 corresponds to two transition segments 114, and each of the two transition segments 114 corresponds to two second segments 115, thereby avoiding isolated segments or nodes. The transition segment 114 serves as a connecting segment between the first segment 113 and the second segment 115, and on the one hand needs to be rigid to ensure good support properties and on the other hand needs to be flexible to be able to conform gradually against the atrial wall 24 in the direction of the second segment 115. The rod width d3 of the transition rod section 114 is thus designed to be 0.2-1mm, and d1 > d3 > d 2. The number of transition segments 114 is adapted according to the number of first segments 113 and second segments 115 to avoid isolated segments or nodes.

Further, the number of rows of the transition rod segments 114 is at least one along the circumference of the valve stent 10. As shown in fig. 5, the transition rod segments 114 are preferably arranged in a row, and further along the circumferential direction of the valve stent 10, so that the first rod segment 113, the second rod segment 115 and the transition rod segments 114 are all arranged in a row, which ensures the simple structure of the valve stent 10 and ensures the support rigidity. In other embodiments, the transition pole segments 114 can be arranged in two rows, or three rows, depending on the actual requirements.

The annulus mating section 116 has a height H that is 0.6 to 2 times the axial dimension of an annulus. Preferably 1.2 to 1.5 times, so that the valve ring matching part 116 can be better clamped on the valve ring 23. For example, preferably, H satisfies the relation: h is more than or equal to 5 and less than or equal to 15 mm. That is, the annulus mating section 116 has a dimension H in the axial direction and is set between 5-15mm such that the annulus mating section 116 not only engages the annulus 23, but also partially passes through the annulus 23 and extends into the left ventricle to engage the native leaflets. The valve ring matching part 116 partially extends into the left ventricle, so that the valve ring matching part 116 is firstly matched with the valve ring 23 when the valve prosthesis 100 is released, a pre-positioning function is provided, and the condition that the rest part of the valve prosthesis 100 is displaced or inclined in the releasing and unfolding processes to influence the final implantation effect is avoided. After implantation, the valve annulus mating portion 116 extends partially into the left ventricle to enhance fixation of the valve prosthesis 100. In addition, the valve annulus matching portion 116 partially extending into the left ventricle can push away the native valve leaflets, limit the movement of the native valve leaflets, and prevent the movement of the native valve leaflets from interfering with the operation of the valve prosthesis 100, for example, to prevent the valve prosthesis 100 from operating simultaneously with the native valve leaflets and causing hemodynamic disorders. In addition, as mentioned above, the valve prosthesis 100 adopts two fixing mechanisms, and under the condition that the atrial matching part 111 can also play a fixing role, the valve ring matching part 116 does not need to extend into the left ventricle too much, the main structure of the valve prosthesis 100 is located in the left atrium 25, and the depth of the valve ring matching part 116 extending into the left ventricle is shallow, so that the native valve leaflets can be pushed away, the function of the left ventricular outflow tract cannot be affected, and the left ventricular outflow tract can be prevented from being obstructed.

As shown in fig. 1 and 5, the annulus matching section 116 matches with the annulus 23, the annulus matching section 116 is connected to the second rod segment 115, and the annulus matching section 116 is connected with the inner stent 12 to form a connecting segment of the outer stent 11 and the inner stent 12.

The annulus matching section 116 includes: a plurality of second struts 117, the plurality of second struts 117 being distributed circumferentially. The number of second struts 117 may be 6-24. The second strut 117 includes: a third rod segment 118 and a fourth rod segment 119, the third rod segment 118 being connected between the second rod segment 115 and one end of the fourth rod segment 119, the other end of the fourth rod segment 119 being connected to the inner support 12, the third rod segment 118 extending in the axial direction of the inner support 12 and the fourth rod segment 119 extending in the radial direction of the inner support 12. That is, after implantation of the valve prosthesis 100, the third rod segment 118 is mated with the annulus 23 such that the valve prosthesis 100 can be fixed at the annulus 23, while the outer stent 11 and the inner stent 12 are fixedly connected by means of the fourth rod segment 119. The stem width d4 of the third stem segment 118 is 0.3-0.8mm so that the third stem segment 118 has sufficient radial support to abut the annulus 23.

In the embodiment of the present invention, the number of the second struts 117 is 12, one second strut 117 is connected to a node of each two connected second rod segments 115, and the second strut 117 includes a third rod segment 118 and a fourth rod segment 119. Preferably, there are two transition segments 114 connected to the same first segment 113, the outflow ends of the two transition segments being remote from each other and extending in a direction away from each other. Two second segments 115 are connected to the same transition segment 114, the outflow ends of the two second segments are far away from each other and extend in a direction away from each other, two adjacent second segments 115 on two different transition segments 114 are connected at their ends, and two adjacent second segments 115 are connected to a third segment 118 of one annulus matching part, thereby making the annulus matching part 116 relatively rigid to support at the annulus. That is, the number of the third rod segments 118 is half less than that of the second rod segments 115, that is, the number of the third rod segments 118 is 12, and the number of the fourth rod segments 119 is 12, the third rod segments 118 correspond to the fourth rod segments 119 in a one-to-one manner, the number of the second struts 117 is small, and the second struts 117 are spaced apart from each other by a large distance, so that the bending of the second struts 117 during the processing of the valve stent 10 is facilitated, for example, the L-shaped annular matching portion 116 is formed, the annular matching portion 116 is connected to the inner stent 12, and the annular matching portion 116 is abutted to the annulus 23.

Preferably, the annulus matching section 116 includes a third rod segment 118 and a fourth rod segment 119. The third pole segment 118 is connected between the second pole segment 115 and one end of the fourth pole segment 119, and the other end of the fourth pole segment 119 is connected to the inner support 12. The third rod segment 118 is arranged to extend in the axial direction of a valve ring 23, or the third rod segment 118 is arranged to be angled in the axial direction of a valve ring 23. That is, the third rod segment 118 is, for example, a support rib, the third rod segment 118 is disposed along the axial direction, and a plurality of the third rod segments 118 are arranged in a ring shape, so that the effect of supporting the valve annulus 23 can be achieved. In a preferred embodiment, the axial direction of the third rod segment 118 is arranged at an angle to the axial direction of the valve stent 10, i.e. the outflow end of the third rod segment 118 is inclined radially outwards towards the valve stent 10, for example at an angle of less than 45 °, preferably 15 °. The inclination angles of all the third rod segments 118 arranged along the circumferential direction are consistent, so that the outer periphery of the valve ring matching part 116 is in a flaring shape, the flaring direction is towards the outflow end, and further the valve ring matching part 116 can clamp the valve ring 23 firmly and prevent the valve ring from loosening. It will be appreciated that the third and

fourth rod segments

118, 119 are not limited to straight rods, but may be rods having a curvature that matches the curvature of the valve annulus. Preferably, when the third rod segment 118 is angled with respect to the axial direction of the valve stent 10, the curvature of the third rod segment 118 is concave inward toward the radial direction of the valve stent 10 to match the configuration of the annulus 23.

And/or the fourth rod segment 119 extends along the radial direction of the inner stent 12, for example, the valve ring matching part 116 is arranged in an L shape, so that the third rod segment 118 is arranged at a distance from the inner stent. Or the fourth rod segment 119 is arranged at an angle with the radial direction of the inner stent 12, for example, the valve ring matching part 116 is arranged in a curve shape, thereby matching the structure of the valve ring 23. Furthermore, the third rod segment 118 is arranged bent with respect to the fourth rod segment 119 at an angle θ of 90 ° -180 °, but not 180 °, to accommodate the valve annulus 23. Moreover, the joint of the third rod segment 118 and the fourth rod segment 119 is a round angle, so that the third rod segment can be rounded excessively, a sharp convex point is prevented from being formed, and the tissue can be effectively prevented from being damaged. Preferably, the radius of the rounded corners is 1-2 mm.

Referring to fig. 5, the sum of the heights of second rod segment 115 and second strut 117 is h1, the height of inner support 12 is h2, and h1 and h2 satisfy the relationship: h1 is less than or equal to h 2. As such, when valve prosthesis 100 is crimped to delivery sheath 210, i.e., when valve prosthesis 100 is in a compressed state, second stem segment 115 and second strut 117 overlap inner stent 12. Although each second segment 115 is flexible, the greater number of second segments 115, when combined together, add rigidly to form a stiffer non-flexing portion a. While the inner frame 12 is used for supporting the valve leaflets 21 and needs to have a relatively high rigidity, the inner frame 12 will form a rigid and inflexible part B after the valve prosthesis 100 is compressed. It should be noted that the inner frame 12 needs to have a proper height based on the leaflet 21, i.e., the height of the non-bendable portion B is difficult to adjust. Thus, in order to relatively minimize the rigid portion and relatively maximize the flexible portion in the axial direction when valve prosthesis 100 is in a compressed state, it is necessary to make the non-flexible portion B cover the non-flexible portion a in the axial direction, and thus, it is necessary to make: h1 is less than or equal to h 2.

The outer stent 11 can be prepared by tube cutting or wire weaving. The outer stent 11 is preferably made of nickel titanium memory alloy, and is shaped into a sphere or a sphere-like shape by utilizing the characteristics of the nickel titanium memory alloy.

As shown in fig. 6, the inner frame 12 includes: the grid frames 121 are arranged and connected in an array mode in the circumferential direction and form a cylindrical or conical shape. That is, the inner frame 12 is a supporting frame composed of a plurality of grids 121, and the outline shape thereof is cylindrical or conical, and in addition, at least a part of the grids 121 is provided with a fixing interface for fixing the valve leaflet 21, and the valve leaflet 21 is sutured through the fixing interface, and the supporting frame provides support for the opening and closing movement of the valve leaflet 21. Wherein the lattice frame 121 has a quadrilateral structure, and the quadrilateral lattice frame 121 facilitates the compression and expansion of the inner frame 12.

Wherein the inner support 12 includes at least three rows of grid frames 121 along the axial direction, in this embodiment, the inner support 12 includes three rows of grid frames 121 along the axial direction, and each row is composed of 12 grid frames 121 distributed circumferentially, it can be understood that in other embodiments not shown, the number of rows of grid frames 121 and the number of each row can be adjusted according to the actual use requirement.

Further, as shown in fig. 6, the grid frame 121 includes, in the axial direction, at a boundary between two adjacent grid frames 121: the fifth rod segment 122 and the sixth rod segment 123, and in particular the lattice frame 121, are quadrilateral in configuration, and the lattice frame 121 is configured to facilitate compression and expansion of the inner stent 12. Each grid 121 comprises two fifth pole segments 122 and two sixth pole segments 123. Since the inner frame 12 includes at least three rows of the grids 121 connected in an array arrangement in the circumferential direction, there is a common situation between two adjacent rows of the grids 121, for example, the sixth rod segment 123 of the grid 121 in the first row is the fifth rod segment 122 of the grid 121 in the second row. For convenience of description and understanding, for a single grid frame 121, the fifth rod segment 122 is located above, the sixth rod segment 123 is located below, the upper ends of the two fifth rod segments 122 are connected to each other, the lower ends of the two 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 rod segments 119 are in one-to-one correspondence with the lowermost grid 121 and are connected to the lower ends of the corresponding two sixth rod segments 123.

As shown in FIG. 6, the height of the fifth pole segment 122 is h3, the height of the sixth pole segment 123 is h4, the height of the second pole segment 115 is h5, and h3, h4, and h5 satisfy the relationship: h3 < h5, h4 < h 5. That is, the dimensions of the fifth rod segment 122 and the sixth rod segment 123 in the axial direction are smaller than the dimensions of the second rod segment 115 in the axial direction, so that the inner stent 12 has high rigidity and sufficient support is provided for the valve leaflet 21. It will be appreciated that the height of the fifth and

sixth rod segments

122, 123 can represent the length of the individual webs in the axial direction of the valve stent 10. In addition, the fifth rod segment 122 and the sixth rod segment 123 may be equal in axial dimension or may be unequal in axial dimension.

And, the width of the fifth pole segment 122 is d5, the width of the sixth pole segment 123 is d6, the width of the second pole segment 115 is d2, and d2, d5 and d6 satisfy the relationship: d2 < d5, d2 < d 6. That is, the rod width of the fifth rod segment 122 and the rod width of the sixth rod segment 123 are both greater than the rod width of the second rod segment 115, so that the inner frame 12 formed by the grid frame 121 has good rigidity and strength, has stability enough to support the movement of the valve leaflet 21, avoids large deformation of the inner frame 12 when the valve leaflet 21 moves, and ensures normal opening and closing of the valve leaflet 21 and fluid dynamics effects. 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 0.3 mm and 1 mm.

Furthermore, as shown in fig. 4 and 6, the inner frame 12 is provided with a leaflet attachment section 124 on the side facing away from the fourth rod section 119 in the axial direction, and the leaflet 21 is fixed to the leaflet attachment section 124. Specifically, the portion of the inner stent 12 between the fixation interface and the node where the two fifth rod segments 122 of the first row of lattice frames 121 connect is the leaflet connecting segment 124. The axial dimension of the leaflet connecting segment 124 is h6, in this embodiment, the inner stent 12 has a cylindrical profile, the radial dimension of the inner stent 12 is D1, and h6 satisfies the relationship: h6 is more than or equal to 8mm and less than or equal to 20mm, and D1 satisfies the relation: d1 is more than or equal to 21mm and less than or equal to 34 mm. In this way, the size of the native valve leaflets and the anatomy of the human body are met, which facilitates the valve prosthesis 100 to function as a native mitral valve.

The inner stent 12 can be manufactured by tube cutting or wire weaving. The material of the inner stent 12 is preferably a nickel titanium shape memory alloy, and the shape of the inner stent is formed into a corresponding shape by utilizing the characteristics of the shape memory alloy. The material of the inner stent 12 may also be cobalt-chromium alloy, stainless steel, titanium alloy, or other materials with good biocompatibility.

A valve prosthesis system according to an embodiment of the second aspect of the invention, comprising: a valve prosthesis 100 and a delivery assembly. Valve prosthesis 100 includes valve stent 10, skirt 22, and leaflets 21 described above. The conveying assembly comprises: a delivery sheath 210 and a guide wire 220, wherein a delivery cavity is arranged in the delivery sheath 210 and is used for loading and delivering the valve prosthesis 100.

Before the valve prosthesis 100 is implanted, a delivery interface is designed on the valve stent 10, and a delivery member (not shown) is connected with the delivery interface. Then, the valvular prosthesis 100 is compressed and gathered, and loaded in the delivery cavity together with the guide wire 220 and the delivery member. It is understood that the delivery lumen may be one lumen or multiple lumens, and when multiple lumens are provided, the valve prosthesis 100, the guidewire 220, and the delivery member may be loaded in different lumens.

Referring to fig. 7 and 8, first, 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 to deliver the valvular prosthesis 100 to the right atrium along the guide wire 220. First shaft segment 113 is then bent to facilitate insertion of valve prosthesis 100 into left atrium 25. Then, after entering the left atrium 25, the valve annulus matching portion 116 is brought into alignment with the valve annulus 23 by the first rod segment 113 being bent again approximately 90 °. Next, the valve prosthesis 100 is passed through the annulus 23, partially extending into the left ventricle. Subsequently, the delivery member pushes valve prosthesis 100 out of the delivery lumen, releasing valve prosthesis 100, and valve prosthesis 100 expands and deploys. Finally, the relevant components of the delivery assembly, such as the delivery sheath 210, the delivery member, and the guidewire 220, are removed.

In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the invention and to simplify the description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are not to be considered limiting of the invention.

In the description herein, references to the description of the term "one embodiment," "some embodiments," "an illustrative embodiment," "an example," "a specific example," or "some examples" or the like mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above do not necessarily refer to the same embodiment or example.

While embodiments of the invention have been shown and described, it will be understood by those of ordinary skill in the art that: various changes, modifications, substitutions and alterations can be made to the embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. A valve stent, comprising: an inner stent, a plurality of first stents, and an annulus matching portion;

a plurality of the first stents are arranged along the axial extension of the valve stent, the outflow end of the first stent is connected with the outer part of the inner stent through the valve ring matching part, and the plurality of the first stents and the valve ring matching part are arranged along the circumferential direction of the inner stent;

when the first stent is in a deployed state, the middle part of the single first stent is convex outwards in the radial direction of the valve stent along the axial direction of the valve stent; a plurality of the first struts forming a space having a spherical or spheroidal shape for supporting the atrium;

the valve ring matching part is used for matching with the valve ring.

2. The valve stent of claim 1, wherein each of the first stents comprises: a first segment and a second segment, the first segment being closer to the inflow end of the valve stent than the second segment, the inflow ends of the first segments being closer to each other, at least two of the second segments being connected to the outflow end of each of the first segments, one end of the second segments being connected to the first segments, the other end of the second segments being connected to the annulus-mating portion.

3. The valve stent of claim 2, wherein each of the first stents further comprises: a transition pole segment connected between the first pole segment and the second pole segment;

the outflow end of each first rod section is connected with at least two transition rod sections, each transition rod section is connected with at least two second rod sections, and/or the number of rows of the transition rod sections is at least one in the circumferential direction of the valve stent.

4. The valve stent of claim 2, wherein there are two of said transition segments attached to the same first segment, the outflow ends of the two transition segments being distal from each other;

the two second rod sections connected to the same transition rod section are far away from each other at the outflow ends; and the number of the first and second groups,

the annulus matching section has a plurality of third segments to which the outflow ends of the second segments of adjacent first stents are connected.

5. The valve stent of claim 2, wherein the first rod segment has a width d1, the second rod segment has a width d2, the transition rod segments have widths d3, and the widths d1, d2 and d3 satisfy the relationship: d1 > d3 > d2, and/or the axial length of the first rod segment is not less than 1/2 of the axial length of the first stent.

6. The valve stent of claim 2, wherein the annulus mating portion comprises: a third segment connected between the second segment and one end of the fourth segment, the other end of the fourth segment connected to the inner support,

the third rod section is used for extending along the axial direction of an annulus, or the third rod section is used for forming an included angle with the axial direction of the annulus;

and/or the fourth rod segment extends along the radial direction of the inner support, or the fourth rod segment and the radial direction of the inner support are arranged at an included angle.

7. The valve stent of claim 6, wherein the sum of the heights of the second and third rod segments is h1, the height of the inner stent is h2, and h1 and h2 satisfy the relationship: h1 is less than or equal to h 2.

8. The valve stent of claim 6, wherein the inner stent comprises: a plurality of grid frames, taking the junction of two adjacent grid frames as a boundary, the grid frames comprising in the axial direction: a fifth pole segment having a height h3, a sixth pole segment having a height h4, a second pole segment having a height h5, h3, h4, and h5 satisfying the relationship: h3 is more than h5, h4 is more than h 5; and/or the presence of a gas in the atmosphere,

the fifth pole segment has a width d5, the sixth pole segment has a width d6, the second pole segment has a width d2, and d3, d4 and d5 satisfy the relationship: d2 < d5, d2 < d 6.

9. The valve holder of claim 1, wherein the valve annulus mating portion has a dimension H in an axial direction of the valve holder, the H being 0.6 to 2 times an axial dimension of an annulus.

10. A valve prosthesis system, comprising: a valve prosthesis and a delivery assembly;

the valve prosthesis comprises the valve stent of any one of claims 1-9, leaflets, and a skirt;

the valve leaflet is fixed on the inner support, and the skirt edge covers the inner surface and/or the outer surface of the valve support;

the delivery assembly comprises: the delivery sheath is internally provided with a delivery cavity which is used for loading and delivering the valve prosthesis.