WO2022037242A1

WO2022037242A1 - Valve stent and prosthetic heart valve

Info

Publication number: WO2022037242A1
Application number: PCT/CN2021/101409
Authority: WO
Inventors: 赖柳山; 陈文俊; 郑伟城
Original assignee: 先健科技(深圳)有限公司
Priority date: 2020-08-20
Filing date: 2021-06-22
Publication date: 2022-02-24
Also published as: CN114073603B; CN114073603A

Abstract

A valve stent (100) having a tubular structure and comprising a support section (10), a transition section (30), and a lobe section (20), the transition section (30) being used for connecting the support section (10) and the lobe section (20), the maximum diameter of the lobe section (20) being less than the maximum diameter of the transition section (30), and the maximum diameter of the transition section (30) being less than or equal to the maximum diameter of the support section (10), the transition section (30) comprising a plurality of first connecting rods (31) and a plurality of second connecting rods (32), and the first connecting rods (31) and the second connecting rods (32) forming at least one open structural unit (303) on the transition section (30), thereby facilitating prevention of the problem of incomplete closure and excessive central reflux easily occurring when the valve stent (100) is implanted in the target position due to the opening and closing effect of the lobe (200) being affected by the form of the target position.

Description

Valve stents and artificial heart valves

technical field

The invention belongs to the technical field of medical devices, and in particular relates to a valve support and an artificial heart valve.

Background technique

The main function of the human heart is to provide power for the blood in the human body. The heart is anatomically divided into: right atrium, right ventricle, left atrium, and left ventricle. Blood flows from the superior vena cava and inferior vena cava into the right atrium, then through the tricuspid valve into the right ventricle, where blood flows through the pulmonary valve into the lungs under the action of right ventricular contraction. The blood flows into the left atrium after being exchanged for oxygen in the lungs, and then flows into the left ventricle through the mitral valve. There are four valves in the human heart, namely the tricuspid valve, the pulmonary valve, the mitral valve and the aortic valve. The tricuspid valve is located between the right atrium and the right ventricle; the mitral valve is located between the left atrium and the left ventricle. Naturally formed normal valves generally have two or three leaflets, and the roots of the leaflets are fixed on the valve annulus; the free edges of the leaflets have no other structures or are connected with chordae tendineae, and the other end of the chordae tendineae is connected to the papilla on the myocardial wall. on the muscle. The function of the valve is to restrict the direction of blood flow. When the valve leaflet is open, it allows blood to flow from the inflow end to the outflow end of the valve, and when the valve leaflet is closed, it prevents blood from flowing from the outflow end to the inflow end of the valve. All four valves are located at the entrance and exit of the ventricle. When the ventricle dilates, the tricuspid and mitral valves open, the pulmonary and aortic valves close, and blood flows from the atrium into the ventricle; when the ventricle contracts, the tricuspid and mitral valves The valves close, the pulmonary and aortic valves open, and blood flows from the ventricles into the arteries. It can be seen that whether the opening and closing function of the valve is normal will directly affect whether the heart function of the human body can provide power for the blood normally.

At present, heart valve disease has become one of the common cardiovascular diseases, and its pathological changes are mainly valvular insufficiency. According to the cause, it can be divided into two categories: the first type is organic, which is due to the organic nature of the valve leaflets themselves. The main causes are congenital malformation or defect of the valve, rheumatic valve disease, calcification, etc.; the second category is functional, the valve itself has no organic disease, mainly due to indirect causes such as atrial enlargement and high pressure. Spatial abnormalities of papillary muscles, chordae tendineae, myocardial wall, etc. In recent years, with the continuous improvement of interventional devices and the accumulation of relevant experience, interventional heart valve stents have begun to be used in aortic valve, pulmonary valve, mitral valve, tricuspid valve and other cases that are not suitable for surgical operations. It is growing rapidly, and multiple clinical trials are also underway. The results of the trials will provide more evidence-based medical evidence for the application of this technology.

However, there are some problems and deficiencies in the current interventional prosthetic heart valve design in clinical use and design stage. For example, in the existing valve, the leaflet is fixed to the support section of the valve stent, and the valve function after implantation is affected by the shape of the support section of the valve stent. There is a big difference in the circular state of the cross section of the stent, the opening and closing effects of the valve leaflets are affected, and the phenomenon of regurgitation and excessive central regurgitation are prone to occur.

SUMMARY OF THE INVENTION

The purpose of the present invention is to at least solve the problem of insufficiency and excessive central regurgitation caused by the influence of the shape of the target position on the opening and closing effect of the valve leaflet when the stent is implanted at the target position.

A first aspect of the present invention provides a valve support, the valve support has a tubular structure, the valve support includes a support section, a transition section and a valve leaflet section, and the transition section is used to connect the support section and the valve support section. The valve leaflet segment, the valve leaflet segment is used for setting the valve leaflet, the support segment is used for supporting the valve support, the maximum diameter of the valve leaflet segment is smaller than the maximum diameter of the transition segment, and the transition segment has a maximum diameter. The maximum diameter is smaller than or equal to the maximum diameter of the support section, wherein the transition section includes several connecting rods, and the connecting rods form at least one open structural unit on the transition section.

According to the valve stent in the invention, by providing a support segment, a transition segment and a valve leaflet segment, the valve leaflet segment is provided with valve leaflets, the support segment is used to support the entire valve stent, and the maximum diameter of the transition segment is smaller than or equal to the maximum diameter of the support segment. , so that the support segment can be supported at the target position for fitting, and the maximum diameter of the valve leaflet segment is smaller than the maximum diameter of the transition segment. When the transition segment fits the target position, the valve leaflet segment provided with the valve leaflet does not need to be completely fitted The target position, so the leaflet segment provided with the leaflet is not easily affected by the shape of the target position, and the problems of insufficiency and excessive central regurgitation occur. In addition, the transition section is used to connect the support section and the leaflet section, and the transition section includes several connecting rods. The connecting rods form an open structural unit on the transition section, so that the radial stiffness of the transition section is reduced, so that the support sections connected at both ends of the transition section are connected. and the valve leaflet segment can be unaffected by each other, which is beneficial to block the radial force transmission from the support segment to the valve leaflet segment, so that during the release process, the valve leaflet segment or the support segment can be completely released first, while the other segment is retained in the delivery sheath. It is beneficial to select the most suitable state for release during use, reducing the difficulty of operation.

In addition, the valve stent according to the present invention may also have the following additional technical features:

In some embodiments of the present invention, the radial stiffness of the transition section is both less than the smallest radial stiffness of the radial stiffness of the support section and the radial stiffness of the leaflet section.

In some embodiments of the present invention, the open structure unit includes a first link and a second link, and one end of the first link is connected with one end of the second link to form a transition section connecting node, The other end of the first link is connected to the leaflet segment, and the other end of the second link is connected to the support segment.

In some embodiments of the present invention, the support section includes a plurality of support rods, the support rods are interconnected to form support section connection points, and the number of transition section connection nodes is less than the number of support section connection points.

In some embodiments of the present invention, the open structural unit includes a third link, a plurality of the third links are arranged at intervals along the circumferential direction of the transition section, and one end of the third link is connected to the The leaflet segments are connected, and the other end of the third link is connected with the support segment.

In some embodiments of the present invention, the projection of the third link on a plane passing through the central axis of the valve support intersects and forms an included angle with the central axis of the valve support.

In some embodiments of the present invention, the projection of the third link on a plane passing through the central axis of the valve holder is parallel to or coincident with the central axis of the valve holder.

In some embodiments of the present invention, the projection of the third link on a plane tangent to the surface of the transition section is any one of a straight line, an arc, or a broken line, or a straight line, an arc A combination of at least two of line or polyline.

In some embodiments of the present invention, the transition section and the support section are connected in a detachable manner, and/or the transition section and the leaflet section are connected in a detachable manner.

Another aspect of the present invention also provides an artificial heart valve, the artificial heart valve has the valve support described in any one of the above, further comprising:

A choke film, the choke film is provided on the valve leaflet segment and the transition segment;

A plurality of valve leaflets, the valve leaflet includes a fixed edge and a free edge, the fixed edge is fixedly connected to the valve leaflet segment, and the free edge is opened and closed at an angle.

Description of drawings

Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are for the purpose of illustrating preferred embodiments only and are not to be considered limiting of the invention. Also, the same components are denoted by the same reference numerals throughout the drawings. in:

1 is a schematic structural diagram of an artificial heart valve according to an embodiment of the present invention;

Fig. 2 is the structural representation of the valve stent in Fig. 1;

Fig. 3 is the structural representation of the valve leaflet segment in Fig. 1;

4 is a schematic structural diagram of a tile-shaped structural unit in an expanded state in FIG. 3;

FIG. 5 is a schematic structural diagram of the tile-shaped structural unit in a contracted state in FIG. 3;

Fig. 6 is the structural representation of the support section in Fig. 1;

Fig. 7 is the structural representation of transition section in Fig. 1;

Fig. 8 is the structural representation of the valve leaflet in Fig. 1;

FIG. 9 is a partial structural schematic diagram of a valve stent according to another embodiment of the present invention;

10 is a partial structural schematic diagram of a third connecting rod according to another embodiment of the present invention;

11 is a partial structural schematic diagram of a third connecting rod according to another embodiment of the present invention;

12 is a partial structural schematic diagram of a third connecting rod according to another embodiment of the present invention;

13 is a partial structural schematic diagram of a third connecting rod according to another embodiment of the present invention;

14 is a partial structural schematic diagram of a third connecting rod according to another embodiment of the present invention;

FIG. 15 is a partial structural schematic diagram of a valve stent according to another embodiment of the present invention;

Fig. 16 is a partial structural schematic diagram of the third connecting rod in Fig. 15;

FIG. 17 is an enlarged schematic view of the structure of part A in FIG. 16 .

The reference numbers in the accompanying drawings are as follows:

1000: artificial heart valve;

100: valve stent;

O: the central axis of the valve stent

10: support section, 11: support rod;

20: leaflet segment, 21: tile-like structural unit, 211: V-shaped link, 212: straight rod, 22: connecting rod;

30: transition section, 31: first link, 32: second link, 33: third link;

40: leaflet frame;

50: connecting part;

60: buckle;

200: leaflet, 210: fixed edge, 220: free edge, 230: valve angle;

A: the first end point, B: the connection point of the support section, C: the connection point of the transition section.

300: blocking film, 301: first blocking film, 302: second blocking film

detailed description

Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention may be embodied in various forms and should not be limited by the embodiments set forth herein. Rather, these embodiments are provided so that the present invention will be more thoroughly understood, and will fully convey the scope of the present invention to those skilled in the art.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, the singular forms "a," "an," and "the" can also be intended to include the plural forms unless the context clearly dictates otherwise. The terms "comprising", "comprising", "containing" and "having" are inclusive and thus indicate the presence of stated features, steps, operations, elements and/or components, but do not preclude the presence or addition of one or Various other features, steps, operations, elements, components, and/or combinations thereof. Method steps, procedures, and operations described herein are not to be construed as requiring that they be performed in the particular order described or illustrated, unless an order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be restricted by these terms. These terms may only be used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of example embodiments.

For ease of description, spatially relative terms may be used herein to describe the relationship of one element or feature to another element or feature as shown in the figures, such as "inner", "outer", "inner" ", "outside", "below", "below", "above", "above", etc. This spatially relative term is intended to include different orientations of the device in use or operation other than the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "above the other elements or features" above features". Thus, the example term "below" can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

For ease of description, the following description uses the terms "proximal" and "distal", where "proximal" refers to the end closest to the operator, "distal" refers to the end away from the operator, and the phrase "axial" In the present invention, "direction" refers to the direction in which the device is advanced and pushed out, and the phrase "circumferential direction" refers to the direction around the axial direction in the present invention.

In this embodiment, "open structure unit" refers to a unit that forms an unclosed structure on the transition section.

As shown in FIG. 1 , the present invention proposes an artificial heart valve 1000 . The artificial heart valve 100 in this embodiment includes a valve stent 100 , a plurality of valve leaflets 200 and a flow blocking membrane 300 . Wherein, the flow blocking membrane 300 covers part of the structure of the valve support 100 , and the function of the blocking membrane 300 is mainly to fix the valve leaflets 200 and prevent blood from passing through areas other than the channels formed between the valve leaflets 200 . The material of the blocking film 300 is preferably a polymer material, such as PET (polyterephthalic acid), PTFE (polytetrafluoroethylene), PU (polyurethane), etc., and biological tissue materials and tissue engineering materials can also be used. Material. The leaflet 200 mainly functions as a one-way valve, allowing blood to flow from one end to the other end of the artificial heart valve and preventing blood from flowing back from the other end to the other end. The valve leaflet 200 is preferably made of biological tissue materials, such as porcine pericardium, bovine pericardium, horse pericardium, sheep pericardium, pig heart valve, etc., and polymer materials and tissue engineering materials can also be used.

The valve stent 100 of the present embodiment has a tubular structure that can be switched between a contracted state and an expanded state, and FIG. 2 shows the expanded state of the valve stent 100 . Wherein, the valve support 100 includes a support segment 10 , a transition segment 30 and a valve leaflet segment 20 which are arranged in sequence. The support segment 10 is a tubular structure in an expanded state, and is used for interference fit with the target position of human tissue after implantation and to generate radial support force, and to fix the artificial heart valve 1000 . The leaflet segments 20 are used to secure the leaflets 200 . The transition segment 30 is used to receive the valve leaflet segment 20 and the support segment 10, so that the support segment 10 and the valve leaflet segment 20 connected at both ends of the transition segment 30 can be unaffected by each other, thereby facilitating the blocking of the support segment 10 to the valve leaflet segment 20. Radial force transmission.

The maximum diameter of the leaflet segment 20 in this embodiment is smaller than the maximum diameter of the support segment 10 , preferably 10% to 20% smaller. After the support segment 10 is in the target position with interference fit to generate a support force, the leaflet segment 20 does not need to be It completely fits the target position, so the leaflet segment 20 provided with the leaflet 200 is not easily affected by the shape of the target position, and the leaflet segment 20 can maintain the original shape, thereby avoiding the problems of insufficiency and excessive central regurgitation.

1 again, the blocking film 300 includes a first blocking film 301 and a second blocking film 302, the first blocking film 301 and the second blocking film 302 are spliced together, wherein the first blocking film 301 is disposed on the In the leaflet segment 20 , the second flow blocking membrane 302 is disposed on the transition segment 30 . The maximum diameter dimension of the valve leaflet segment 20 is smaller than the maximum diameter dimension of the transition segment 30. Therefore, even if the valve leaflet segment 20 does not completely fit the target position, as long as the transition segment 30 can be fully fitted to the target position, it is arranged at the first position of the transition segment 30. The second flow blocking membrane 302 can effectively prevent the penetration of blood.

The blocking membrane 300 of this embodiment is fixedly connected to the valve stent 100 by sutures, for example, is disposed on the inner surface or the outer surface of the valve stent 100 , and the blocking membrane 300 covers the valve leaflet section 20 and the transition section 30 of the valve stent 100 . , the function of the baffle film is mainly to fix the valve leaflet 200 and prevent the blood from flowing from the area outside the channel formed by the free edge 220 of the valve leaflet 200 . The first blocking membrane 301 of the valve leaflet segment 20 can be made of a cylindrical cloth with the same size as the inner surface shape of the expanded valve stent 100, and the first blocking membrane 301 is not connected to the second blocking membrane 302. The contour of one end can be trimmed according to the shape of the edge of the fixed side of the valve support 100 or the valve leaflet 200, or a flat mouth can be used directly. The second flow blocking membrane 302 of the transition section 30 can be directly sewed with a tubular cloth of the same size as the expanded transition section 30 structure, or can be formed by splicing and stitching several fan-shaped small pieces. The second flow blocking membrane 302 of the transition section 30 It can more effectively prevent peripheral leakage. The suturing of the blocking membrane 300 is performed in the natural state of the expanded valve stent 100 , and the surface of the blocking membrane 300 is kept compact without affecting the shape of the valve stent 100 . The materials of the first flow blocking membrane 301 of the leaflet segment 20 and the second flow blocking membrane 302 of the transition section 30 may be different or the same. The material of the suture is preferably a polymer material, such as PET, PTFE, PU and the like.

Referring to FIG. 3 , the valve leaflet segment 20 is a tubular structure composed of a plurality of tile-shaped structural units 21 . During the switching process between the contracted state and the expanded state of the valve stent 100 , any axially collinear portion of the tile-shaped structural unit 21 The axial length between the two points remains the same.

By designing the valve leaflet segment 20 as a tubular structure composed of a plurality of tile-like structural units 21, and in the process of switching between the contracted state and the expanded state of the valve stent 100, any axially collinear on the tile-like structural units 21 The axial length between the two points remains unchanged, which is beneficial to prevent the valve leaflet 200 and the blocking membrane 300 fixed on the valve leaflet segment 20 from being subjected to axial tension due to the axial deformation of the valve stent 100 during the process of sheathing and shrinking. , thereby effectively preventing the valve stent 100 from leaking due to tearing of the flow blocking membrane and the valve leaflets 200 .

With reference to FIGS. 3 to 5 , in this embodiment, the plurality of tile-shaped structural units 21 of the valve leaflet segment 20 are sequentially arranged along the circumferential direction and the axial direction of the valve leaflet segment 20 . The tile-shaped structural unit 21 includes two V-shaped connecting rods 211 and two straight rods 212 . The two V-shaped links 211 are arranged at intervals along the axial direction of the leaflet segment 20 , and the opening directions of the two V-shaped links 211 are the same. The two straight rods 212 are arranged at intervals along the circumferential direction of the leaflet segment 20 , and the two V-shaped links 211 are connected by the two straight rods 212 . Wherein, the V-shaped connecting rod 211 is formed by connecting two sections of curved rods, and the first end point A is formed at the connection of the two sections of curved rods. Both ends of each V-shaped link 211 are fixed on adjacent straight rods 212 evenly distributed in the circumferential direction. The valve 200 is effectively supported, and in the process of the valve leaflet segment 20 being squeezed and deformed, the deformation of each position in the circumferential direction is kept consistent. In the axial direction, the circumferentially distributed V-shaped connecting rods 211 adopt an equidistant array, the number of arrays is greater than or equal to 2, and the spacing of the arrays is greater than the distance between the two ends of the curved rod, that is, the length of the straight rod 212 is greater than that of the V-shaped connecting rod 211. The maximum length in the axial direction of the leaflet segment 20 is preferably 3 rows, so as to ensure that the V-shaped link 211 has sufficient deformation space in the axial direction during the process of the leaflet segment 20 being squeezed and deformed. The two V-shaped connecting rods 211 disposed adjacent to each other in the axial direction are prevented from being pressed against each other, thereby causing tearing of the flow blocking membrane and the valve leaflets 200 , thereby causing leakage of the valve stent 100 .

4 and 5 again, when the tile-shaped structural unit 21 is switched between the contracted state and the expanded state, the straight rod 212 is not deformed during the switching process, and still retains the vertical state in the axial direction. The V-shaped link 211 is deformed. Since the structures of the two V-shaped links 211 are the same, the synchronous deformation is always maintained during the state switching process of the tile-shaped structural unit 21, and the axial distance between the two V-shaped links 211 is always maintained. In order to ensure that the distance between any axially collinear two points in the tile-shaped structural unit 21 will remain unchanged when the valve stent 100 is switched between the expanded state and the contracted state.

As also shown in FIG. 3 , in some embodiments of the present invention, the leaflet segment 20 further includes a leaflet frame 40 . The leaflet frame 40 is disposed at the end of the leaflet segment 20 that is not connected to the transition segment 30. Specifically, the leaflet frame 40 is arranged on the straight rod 212 at equal intervals. In this embodiment, the leaflet frame 40 is provided with The leaflet frame is used to fix the valve angle of the leaflet 200 on the straight rods 212 that are equally spaced as the number of leaflets 200 . The inside of the leaflet frame 40 is provided with a rectangular hollow structure for fixing the valve angle of the leaflet 200 . The valve stent 100 of the present embodiment further includes a connecting portion 50 . The connecting portion 50 is connected to the end of the leaflet frame 40 , and the leaflet frame 40 is disposed between the connecting portion 50 and the straight rod 212 . The connecting portion 50 is a T-shaped structure, and the connecting portion 50 is used to connect the valve stent 100 and the delivery device during the delivery process.

As shown in FIG. 6 , the support section 10 of the present embodiment has a tubular structure as a whole in an expanded state, and includes a plurality of support rods 11 , and the plurality of support rods 11 are connected through the support section connection point B to form a circumferential closed shape . The head and tail of each support rod 11 are connected through the support section connection point B to form a diamond-shaped structural unit. The diamond-shaped structural units are distributed in a uniform array around the axis of the support section 10 , and the number of arrays is preferably an integer multiple of the number of straight rods 212 of the leaflet section 20 . The second, third and even more layers in the axial direction are then designed through the honeycomb structure. In this embodiment, considering that the overall length of the valve stent 100 should not be too long, it is preferable that the support section 10 has two layers of diamond-shaped structural units. The use of diamond-shaped structural units for the support section 10 can ensure that sufficient radial support force can still be provided when compressed to a smaller diameter.

As shown in FIG. 7 , in the expanded state, the transition section 30 has a tubular structure with a large proximal end and a small distal end as a whole. The transition section 30 includes a plurality of first connecting rods 31 and a plurality of second connecting rods 32. One end of the first connecting rod 31 is connected with one end of the second connecting rod 32 to form a connecting node C of the transition section. The other end is connected to the leaflet segment 20 , and the other end of the second link 32 is connected to the support segment 10 . In this embodiment, the two first links 31 and the two second links 32 form an "X"-shaped open structure unit 303 , the length of the first links 31 is greater than the length of the second links 32 , and the second The length of the connecting rod 32 is approximately equal to the length of the support rod 11, so that the distance between any two adjacent first connecting rods 31 in the circumferential direction is greater than any two adjacent second connecting rods 32 in the circumferential direction. The distance between them ensures that the transition section 30 has better compressibility. Meanwhile, the number of transition section connection nodes C is less than the number of support section connection points B in the same circumferential direction on the support section 10 , and the number of support section connection points B is an integer multiple of the number of transition section connection nodes C. The reduction in the number of end points in the circumferential direction of the transition section 30 can reduce the radial stiffness of the valve stent 100 , and can effectively prevent the support section 10 from transmitting radial force to the valve leaflet section 20 .

1 and 3 again, the proximal end of the valve leaflet segment 20 in this embodiment is further provided with a connecting rod 22 arranged in the axial direction, and the connecting rod 22 is provided on two adjacent tile-shaped structural units. 21, one end of the first connecting rod 31 is connected to the proximal end of the valve leaflet segment 20 through the connecting rod 22, the other end of the first connecting rod 31 is connected to one end of the second connecting rod 32 through the transition section connecting node C, The other end of the second link 32 is connected to the distal end of the support section 10 through the support section connecting point B. The transition section 30 is provided with an open structural unit 303, so that it does not form a closed structure unit, so that the transition section 30 has a weaker radial rigidity, so that the support section 10 and the leaflet section 20 connected at both ends of the transition section 30 can not be affected by each other. Therefore, it is beneficial to block the radial force transmission from the support segment 10 to the valve leaflet segment 20, so that during the release process, the valve leaflet segment 20 or the support segment 10 can be completely released first, while the other segment is retained in the delivery sheath, which is beneficial to Choose the most suitable state to release during use to reduce the difficulty of operation. The valve stent 100 is made of an alloy tube by laser cutting, and the material is preferably superelastic nickel-titanium alloy and stainless steel, and is subsequently expanded, shaped and surface treated by heat treatment to achieve the required design shape, size and surface quality.

By arranging the valve leaflet segment 20 and the support segment 10 separately on the valve support 100, and providing a buffering transition segment 30 between the valve leaflet segment 20 and the support segment 10, the shrinkage of the valve support 100 can be effectively reduced The radial force transmitted by the support segment 10 to the valve leaflet segment 30 during the deformation process can achieve the ideal working state of retaining the circular cross-section of the valve leaflet 200 to a greater extent. At the same time, the transition section 30 of the valve stent 100 adopts a structure with lower rigidity (open structural unit). During the release process of the valve stent 100, the valve leaflet section 20 or the support section 10 can be completely released first, while the other section is retained in the delivery sheath. It is beneficial to select the most suitable state for release during use, reducing the difficulty of operation.

1 and FIG. 8 , the artificial heart valve 1000 of this embodiment is provided with three leaflets 200 in total. The structure and shape of the leaflets 200 are the same. internal. The valve leaflet 200 includes a fixed edge 210 and a free edge 220, wherein the fixed edge 210 is fixed on the blocking membrane of the valve leaflet segment 20 by sutures, and the free edge 220 is not constrained and can be opened and closed at an angle. The valve angle 230 passes through the leaflet frame 40 of the leaflet segment 20 from the inside to the outside, and then goes around the rod on the leaflet frame 40 and folds back outward to fit the valve leaflet 200 in the valve support 100, and use sutures to be fixed.

In other embodiments of the present invention, the structure of the transition section 30 of the valve stent 100 is different from the above-mentioned embodiments. As shown in FIG. 9 , in this embodiment, the transition section 30 is composed of a plurality of third connecting rods 33 spaced in the circumferential direction, and the third connecting rods 33 may be simple straight rods. The distal end of the third link 33 is connected to the first end point A of the proximal end of the valve leaflet segment 20 , and the proximal end of the third link 33 is connected to the support segment connection point B at the distal end of the support segment 10 . The projection of the third link 33 on the plane of the central axis O of the valve stent is parallel to or coincident with the central axis O of the valve stent.

In the above embodiment, by replacing the first link 31 and the second link 32 with the third link 33, the existence of the transition section connecting node C on the transition section 30 is eliminated, thereby reducing the radial stiffness of the transition section 30, In turn, it is beneficial to block the transmission of radial force from the support segment 10 to the leaflet segment 20 . It can be understood that the open structural unit includes the third connecting rod 33 , and the arrangement of the third connecting rod 33 on the transition section 30 forms an open structural unit on the transition section 30 .

In other embodiments of the present application, the structure of the third link 33 may also be modified. The projection of the third link 33 on the plane tangent to the surface of the transition section 30 is any one of a straight line, an arc shape or a broken line shape, or a combination of at least two of the straight line, arc shape or broken line shape . 10 to 14 , the projection of the third link 33 on a plane tangent to the surface of the transition section 30 may be an arc segment, a multi-rod segment with an angle, a curved segment with a wave circle, a belt Either a bent bar segment with multiple S-bends or a multi-bar segment with a dash shape. By arranging various bending structures on the third connecting rod 33, an elastic member can be added to the third connecting rod 33 in the axial direction, which reduces the rigidity of the third connecting rod 33 itself, thereby reducing the transition section. The radial stiffness of 30 is favorable for blocking the transmission of radial force from the support segment 10 to the leaflet segment 20 .

As shown in FIG. 15 , in other embodiments of the present application, the projection of the third link 33 on the plane of the central axis O of the transvalvular stent intersects and forms an included angle with the central axis O of the valve stent, that is, the The third link 33 is inclined in the axial direction. By slanting the third connecting rod 33 in the axial direction, the valve stent 100 can be twisted to relieve the pressure when it is under force, thereby reducing the radial stiffness of the transition section 30, thereby facilitating the blocking of the support section 10 from the valve leaflet. Segment 20 transmits radial forces.

In other embodiments of the present application, the transition segment 30 and the valve leaflet segment 20 and/or the support segment 10 adopt a split structure design, that is, the transition segment 30 is detachably connected to the valve leaflet segment 20 and/or the support segment 10 in a detachable manner. connected. 16 and 17 , in this embodiment, one end of the leaflet segment 20 , both ends of the third link 33 and one end of the support segment 10 are provided with mounting holes, and one end of the third link 33 passes through a retaining ring 60 is connected to one end of the leaflet segment 20 through the mounting hole, and the other end of the third link 33 is connected to one end of the support segment 10 through the retaining ring 60 through the mounting hole, so that the two ends of the third link 33 are respectively connected to the one end of the support segment 10. The first end point A is independent of the connection point B of the support segment, so as to avoid the transmission of torque generated by the support segment 10 at the connection point B of the support segment, thereby reducing the influence on the deformation of the leaflet segment 20 .

The above description is only a preferred embodiment of the present invention, but the protection scope of the present invention is not limited to this. Substitutions should be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.

Claims

A valve support, characterized in that the valve support has a tubular structure, the valve support includes a support section, a transition section and a valve leaflet section, and the transition section is used to connect the support section and the valve leaflet section, The valve leaflet segment is used to set the valve leaflet, the support segment is used to support the valve support, the maximum diameter of the valve leaflet segment is smaller than the maximum diameter of the transition segment, and the maximum diameter of the transition segment is smaller than or It is equal to the largest diameter dimension of the support section, wherein the transition section includes several connecting rods, and the connecting rods form at least one open structural unit on the transition section.
The valve stent according to claim 1, wherein the radial stiffness of the transition section is smaller than the smallest radial stiffness among the radial stiffness of the support section and the radial stiffness of the valve leaflet section.
The valve stent according to claim 1, wherein the open structural unit comprises a first connecting rod and a second connecting rod, and one end of the first connecting rod is connected with one end of the second connecting rod to form a The transition segment is connected to a node, the other end of the first link is connected to the leaflet segment, and the other end of the second link is connected to the support segment.
The valve stent according to claim 3, wherein the support section includes a plurality of support rods, the support rods are connected to each other to form support section connection points, and the number of connection nodes of the transition section is less than that of the support section The number of connection points.
The valve support according to claim 1, wherein the open structural unit comprises a third connecting rod, a plurality of the third connecting rods are arranged at intervals along the circumferential direction of the transition section, and the third connecting rods are arranged at intervals along the circumferential direction of the transition section. One end of the rod is connected to the leaflet segment, and the other end of the third link is connected to the support segment.
The valve holder according to claim 5, wherein the projection of the third link on a plane passing through the central axis of the valve holder intersects and forms an included angle with the central axis of the valve holder.
The valve holder according to claim 5, wherein the projection of the third link on a plane passing through the central axis of the valve holder is parallel to or coincident with the central axis of the valve holder.
The valve support according to claim 5, wherein the projection of the third link on a plane tangent to the surface of the transition section is any one of a straight line, an arc, or a broken line, or It is a combination of at least two of straight line, arc or polyline.
The valve support according to claim 1, wherein the transition section and the support section are connected in a detachable manner, and/or the transition section and the valve leaflet section are detachably connected way connected.
An artificial heart valve, characterized in that it has the valve support according to any one of claims 1 to 9, further comprising:

A choke film, the choke film is arranged on the valve leaflet segment and the transition segment;

A plurality of valve leaflets, the valve leaflet includes a fixed edge and a free edge, the fixed edge is fixedly connected to the valve leaflet segment, and the free edge is opened and closed at an angle.