Valve prosthesis for replacing mitral valve

Abstract

The invention relates to the field of medical instruments, in particular to a valve prosthesis for replacing a mitral valve, which comprises an outer stent and an inner stent, the outer stent is provided with a fabric layer, the inner stent is provided with an artificial valve leaflet, the outer stent comprises an anchoring section and a self-adaptive section, the anchoring section comprises a grid-type stent and an anchoring assembly, the anchoring assembly comprises a cannula part, a puncture part and a control wire, and the self-adaptive section is provided with a control wire. Barbs and a connecting hole are arranged on the puncture part, the puncture part is arranged in the sleeve part, the puncture part is fixedly connected with the sleeve part, an opening is formed in the sleeve part, and when the control wire penetrates through the connecting hole and is clamped with the other end of the sleeve part in a matched mode to achieve detachable connection, the barbs are limited in the sleeve part; when the control wire is pulled out of the connecting hole, the barbs extend out of the opening and penetrate through the fabric layer to be pricked into the heart tissue; release of the barbs on the puncture part is controllable, an operator can release the stent firstly and then adjust the stent to an ideal position, and then the barbs are further released to anchor the stent.

Description

Technical Field

[0001] This application relates to the field of medical devices, and particularly to a valve prosthesis for replacing the mitral valve. Background Art

[0002] Currently, the conditions affecting the function of the heart mitral valve include: mitral regurgitation, mitral valve leaflet prolapse, mitral stenosis, etc. Mitral regurgitation refers to the leakage of blood flow from the left ventricle to the left atrium caused by the inability of the mitral valve leaflets to close during the peak blood pressure in the cardiac systolic phase. The structural reasons leading to the abnormal closure of the mitral valve leaflets include: leaflet damage, annulus dilation, chordae tendineae rupture, and papillary muscle ischemia, etc. Leaflet prolapse or the convexity of the leaflet towards the atrial side, which causes abnormal leaflet structure, will also lead to mitral regurgitation. The normal function of the mitral valve can also be affected by mitral stenosis or the narrowing of the mitral valve opening, which will cause obstruction to the blood flow from the atrium to the ventricle during the cardiac diastolic phase.

[0003] Mitral regurgitation is mainly treated with drugs and surgery to reduce the blood flow reflux to the atrium. For example, by means of repair, the dilated annulus is clamped or cut to make the leaflets close well. Clamping the annulus makes the dilated annulus contract by implanting a circumferential ring around the annulus. Other repair surgeries also include suturing or clamping the leaflets to make the leaflets close well. Or, more interventional surgeries include replacing the entire native valve with a mechanical or biological valve. This surgical method is mostly carried out through open-chest extracorporeal circulation, which will cause greater trauma to the patient, is more likely to cause pain, death, and requires a longer recovery time.

[0004] Less-invasive aortic valve replacement surgeries have been carried out in recent years. These aortic valve prostheses include expandable stents and a three-leaflet valve prosthesis. The expandable stent is used to fit with the relatively rigid aortic root of a symmetric circumferential type. These characteristics of the aortic root determine that the expandable stent can fit with it and is not easily displaced or shed.

[0005] Compared with the aortic valve anatomical structure, the complex anatomical structure of the mitral valve poses challenges to mitral valve replacement. First, different from the relatively symmetric and native rigid annulus of the aorta, the mitral annulus presents a D-shaped saddle shape, lacks symmetry, and the annulus size changes greatly during the cardiac cycle. These uncertainties pose challenges to designing a suitable valve prosthesis that can fit the mitral annulus. If there is insufficient contact between the valve prosthesis and the mitral annulus, resulting in gaps, it will lead to blood flow reflux. If an expandable stent is implanted, it may cause paravalvular leakage.

[0006] For example, Patent CN202311077193.6 discloses a valve prosthesis device with a segmented conical structure. It includes an outer stent and an inner stent; the outer stent includes a disc-shaped structure that unfolds on the atrial side, an annular structure adapted to the annulus side, and a split structure with different tapers that unfolds on the ventricular side; a resilient clamping member is distributed around the circumference of the outer stent according to the original leaflets; the inner stent is connected inside the outer stent, and a valve body is provided in the inner stent. It also includes barbs or protrusions selectively or integrally distributed on the annular structure of the outer stent, which are used to anchor the prosthesis to the congenital valve annulus of the heart. The disc-shaped structure and the annular structure are circular structures or irregular structures, and the split structures with different tapers are distributed at 60° - 120°. The use of a split conical structure can reduce the obstruction of the outflow tract and improve the adaptability of the prosthesis. The patent solution mainly uses the clamping member and the barbs distributed on the outer stent to achieve anchoring. After the barbs on the outer stent are detached from the delivery sheath, they will be immediately released and come into contact with the tissues in the heart and penetrate into the tissues. Due to the reason of non-visibility during the operation, the release position of the stent cannot be determined once in most cases. Often, after the stent is released from the delivery sheath, the relative position with the patient's own valve needs to be further adjusted through imaging observation. However, once the barbs are released and penetrate into the tissues, adjusting the position of the stent will inevitably damage the heart tissues.

[0007] In summary, the existing replacement valve prostheses have at least the following technical pain points: Although a stent with a large diameter can provide radial support force, it will squeeze other heart tissues and cause varying degrees of impact on other vascular tissues; while the barbs can provide a certain amount of anchoring force, the release of the barbs will be immediately released after detaching from the delivery tube, resulting in the uncontrollable position of the stent in the heart after release, the valve stent cannot be adjusted to an ideal position, and problems such as varying degrees of paravalvular leakage occur after surgery. Summary of the Invention

[0008] In view of the above and other more ideas, this application is proposed.

[0009] One of the purposes of this application is to overcome the deficiencies of the prior art. A valve prosthesis for replacing the mitral valve is provided for problems such as the radial support of the outer stent in the prior art causing extrusion of other heart tissues and the uncontrollable release of the barbs after detaching from the delivery tube.

[0010] The technical solution adopted to solve the technical problem of the present invention is to provide a valve prosthesis for replacing the mitral valve, including an outer stent and an inner stent. The outer stent is coated with a fabric layer, and the inner stent is provided with artificial valve leaflets. The outer stent includes an anchoring section and an adaptive section. The anchoring section includes a grid-type stent and an anchoring component connected to the grid-type stent. Among them, the anchoring component includes a sleeve member, a piercing member, and a control wire. The piercing member is provided with a plurality of barbs tilted obliquely outwards and a connection hole. Among them, the piercing member is arranged inside the sleeve member, and one end of the piercing member is fixedly connected to one end of the sleeve member. Moreover, the sleeve member is provided with an opening corresponding to the barb. When the control wire passes through the connection hole and is engaged with the other end of the sleeve member to achieve detachable connection, at this time, the barb is restricted inside the sleeve member; when the control wire is withdrawn from the connection hole, the barb extends out from the opening and penetrates through the fabric layer and pierces into the heart tissue. By adopting the above solution, the operator can first release the outer stent during the operation and observe the position of the outer stent in the heart through imaging. When adjusted to a relatively ideal position, then withdraw the control wire so that the barb extends out from the sleeve member, penetrates through the fabric layer, and pierces into the heart tissue. Multiple barbs piercing into the tissue can provide sufficient anchoring force. The outer stent does not need to rely on radial expansion of the autologous valve annulus to obtain anchoring force, avoiding compression of the heart tissue. At the same time, the operator can first adjust the position of the outer stent and then release the barb in a controllable manner, making the implantation position of the valve prosthesis more ideal and avoiding problems such as paravalvular leakage after the operation.

[0011] As a further improvement of the present invention, in the natural state, the distance from the connection hole to the other end of the sleeve member is greater than or equal to the length of the barb; the purpose of such a design is to ensure that during loading, the barb is completely compressed and restricted inside the sleeve member, and no part of the barb will be exposed outside to cause damage to the heart tissue.

[0012] As a further improvement of the present invention, a connection ring and a limiting rod are arranged inside the grid-type stent. The sleeve member is fixedly connected to the connection ring. One end of the limiting rod is fixed inside the grid-type stent, and the other end of the limiting rod is free towards the lower end of the grid-type stent. Moreover, one end of the limiting rod is at the same height as the connection ring, ensuring that the anchoring component is in a horizontal state relative to the outer stent.

[0013] As a further improvement of the present invention, during preloading, the outer stent is compressed inside the delivery tube, and the sleeve member and the piercing member are also in a straightened state. Such a design is beneficial for loading and delivery.

[0014] As a further improvement of the present invention, one end of the sleeve member is provided with a bending adjustment section. When the control wire passes through the connection hole and is detachably connected with the other end of the sleeve member by means of clamping, the bending adjustment section bends; when the control wire is withdrawn from the connection hole, the bending adjustment section resumes its preset shape and drives the puncturing member to move, so that the barbs extend out from the opening and penetrate through the fabric layer and into the heart tissue.

[0015] As a further improvement of the present invention, the stiffness of the bending adjustment section is less than that of the rest of the sleeve member. Keeping the sleeve member stationary and pulling the puncturing member can cause the bending adjustment section to bend. When the control wire is withdrawn from the connection hole, the bending adjustment section will have a restoring force, which can pull the puncturing member to move relative to the sleeve member, so that the barbs extend out from the opening.

[0016] As a further improvement of the present invention, both the sleeve member and the puncturing member are designed with preset shapes, and the preset shapes match the inner contour of the mesh-type stent. After the outer stent is released, the sleeve member and the puncturing member will return to their preset shapes along the inner side of the outer stent.

[0017] As a further improvement of the present invention, the limiting rod is an arc-shaped rod. After the outer stent is released, the anchoring assembly returns to its preset shape along the inner side of the outer stent. And when the control wire is withdrawn from the connection hole, since there will be an upward pulling force when the control wire is withdrawn from the connection hole, the limiting rod can limit the anchoring assembly from moving towards the upper end of the outer stent.

[0018] As a further improvement of the present invention, the mesh-type stent is composed of a plurality of diamond-shaped meshes, and the opening of the sleeve member is arranged in the middle area of the diamond-shaped meshes. Such a design aims to ensure that the barbs will not interfere with the outer stent when extending out, and ensure that the barbs can penetrate through the fabric layer and into the heart tissue.

[0019] As a further improvement of the present invention, there is more muscle tissue in the posterior leaflet area, while there is less muscle tissue in the anterior leaflet area and it is adjacent to the aortic blood vessel. Therefore, after the outer stent is implanted, the anchoring section is correspondingly arranged in the posterior leaflet area to provide sufficient anchoring force to ensure the position of the valve prosthesis in the heart. The adaptive section is correspondingly arranged in the anterior leaflet area, the anchoring assembly is correspondingly arranged in the annulus area, and the barbs extend out from the opening and penetrate through the fabric layer and into the annulus tissue of the posterior leaflet area.

[0020] As a further improvement of the present invention, the rigidity strength of the anchoring section is greater than that of the adaptive section. Wherein, the adaptive section includes a flexible framework and a diamond-shaped support structure connected to the flexible framework. The left and right ends of the diamond-shaped support structure are respectively fixedly connected to the anchoring section. The flexible framework is made of thinner shape memory metal wires and can undergo dynamic adaptive deformation, while the diamond-shaped support structure can provide a certain amount of supporting force to maintain the shape of the stent. The purpose of such a design is as follows: The anchoring section is located in the posterior leaflet area and mainly provides sufficient anchoring force. The anterior leaflet area is adjacent to the aortic blood vessel and has less muscle tissue, making it inconvenient to perform the anchoring operation. Therefore, the adaptive section is correspondingly arranged in the anterior leaflet area. After the outer stent is implanted, the adaptive section fits the autologous anterior leaflet annulus. Moreover, the adaptive section can undergo adaptive deformation following the opening and closing of the autologous valve, so that the adaptive section can always fit the autologous anterior leaflet annulus, which can not only ensure the anchoring effect of the valve stent but also avoid the problem of paravalvular leakage.

[0021] Compared with the prior art, the advantages of the technical solution of the present application at least include the following: In the prior art, the barbs are released together with the stent, and the operator needs to first release the stent and then observe the relative position between the stent and the valve through imaging before making adjustments. However, after the barbs are released, they will immediately come into contact with the cardiac tissue and penetrate into the tissue, resulting in the barbs scratching the cardiac tissue when the operator makes position adjustments; according to an idea of the present application, the barbs on the puncture member can be controlled to be released by a control wire. When the outer stent is released, the operator can first adjust the position of the outer stent. When adjusted to the ideal position, the control wire is then withdrawn, so that the barbs extend out from the opening and penetrate through the fabric layer into the annulus tissue. Multiple barbs penetrating into the tissue can provide sufficient anchoring force, and the outer stent does not need to rely on radially expanding the autologous valve annulus to obtain the anchoring force, avoiding compression of the cardiac tissue. At the same time, the implantation position of the valve prosthesis is more ideal, avoiding problems such as paravalvular leakage after surgery.

[0022] According to an idea of the present application, the restoring force of the bending adjustment section is used to drive the puncture member, so that the barbs can extend out from the opening of the sleeve member, with a simple structure and convenient operation.

[0023] According to an idea of the present application, the distance from the connection hole to the other end of the sleeve member is greater than or equal to the length of the barb; the purpose of such a design is to ensure that when loaded, the barbs are completely compressed and restricted within the sleeve member, and no part of the barbs will be exposed outside to cause damage to the cardiac tissue.

[0024] According to an idea of the present application, the rigidity strength of the anchoring section is greater than that of the adaptive section. The purpose of such a design is as follows: The anchoring section is located in the posterior leaflet region and mainly provides sufficient anchoring force. The anterior leaflet region is adjacent to the aortic blood vessel and has less muscle tissue, making it inconvenient to perform the anchoring operation. Therefore, the adaptive section is correspondingly arranged in the anterior leaflet region. After the outer stent is implanted, the adaptive section fits the autologous anterior leaflet annulus, and the adaptive section can undergo adaptive deformation following the opening and closing of the autologous valve, so that the adaptive section can always fit the autologous anterior leaflet annulus, which can not only ensure the anchoring effect of the valve stent but also avoid the problem of paravalvular leakage.

[0025] The embodiments of the present application can achieve other beneficial technical effects that are not listed one by one. Some of these other technical effects may be described below, and can be expected and understood by those skilled in the art after reading the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] By referring to the following description in conjunction with the drawings, the above-mentioned features and advantages of these embodiments and other features and advantages, as well as the ways to achieve them, will become more obvious, and the embodiments of the present application can be better understood. In the drawings: Figure 1 It is a schematic diagram of the overall structure of the outer stent of the present invention.

[0027] Figure 2 It is a schematic diagram of the side structure of the outer stent of the present invention.

[0028] Figure 3 It is a top view of the outer stent of the present invention.

[0029] Figure 4 and Figure 5 is Figure 1 a partially enlarged inner view of the outer stent in.

[0030] Figure 6 It is a schematic diagram of the structure in which the barbs of the present invention are released.

[0031] Figure 7 is Figure 6 a partially enlarged inner view of the outer stent in.

[0032] Figure 8 It is a schematic diagram of the structure in which the outer stent is loaded.

[0033] Figure 9 It is a schematic diagram of the structure in which the outer stent of the present invention is combined with the valve stent.

[0034] Figure 10 It is a schematic diagram of the structure after the valve prosthesis of the present invention is implanted.

[0035] The features referred to by each number in the drawings are as follows: 1-Outer stent, 2-Inner stent, 3-Fabric layer, 4-Artificial valve leaflet, 5-Anchoring section, 51-Mesh stent, 511-Connection ring, 512-Limiting rod, 52-Anchoring component, 521-Sleeve part, 5211-Opening, 5212-Bending adjustment section, 522-Puncture part, 5221-Barb, 523-Control wire, 6-Self-adaptive section, 61-Flexible framework, 62-Rhombic support structure. Detailed implementation manners

[0036] In the following descriptions of the drawings and the detailed implementation manners, the details of one or more embodiments of the present application will be elaborated. From these descriptions, the drawings and the claims, other features, objectives and advantages of the present application can be clearly understood.

[0037] It should be understood that the illustrated and described embodiments are not limited to the details of the construction and arrangement of the components set forth in the following descriptions or illustrated in the drawings in their applications. The illustrated embodiments can be other embodiments and can be implemented or executed in various ways. Each example is provided by way of explaining rather than limiting the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of the present application without departing from the scope or essence of the disclosure of the present application. For example, the features illustrated or described as part of one embodiment can be used with another embodiment to still produce additional embodiments. Therefore, the disclosure of the present application covers such modifications and variations that fall within the scope of the appended claims and their equivalent elements.

[0038] Similarly, it can be understood that the phrases and terms used herein are for the purpose of description and should not be considered restrictive. The use of "including", "comprising" or "having" and their variants herein is intended to open-endedly include the items listed thereafter, their equivalents and additional items.

[0039] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the present application.

[0040] One of the purposes of the embodiments described below is to aim to solve the above defects and other problems.

[0041] Embodiment 1

[0042] As Figure 1 , Figure 2 and Figure 3As shown, a valve prosthesis for replacing the mitral valve according to an embodiment of the present application is illustrated, including an outer stent 1 and an inner stent 2. The outer stent 1 is coated with a fabric layer 3. The inner stent 2 is provided with artificial valve leaflets 4. The outer stent 1 includes an anchoring section 5 and an adaptive section 6. The anchoring section 5 includes a grid-type stent 51 and an anchoring component 52 connected to the grid-type stent 51. Among them, the anchoring component 52 includes a sleeve member 521, a puncturing member 522, and a control wire 523. A plurality of barbs 5221 that tilt obliquely outwards and connection holes (not shown) are provided on the puncturing member 522. Among them, the puncturing member 522 is arranged inside the sleeve member 521. One end of the puncturing member 522 is fixedly connected to one end of the sleeve member 521 (usually by metal welding). One end of the sleeve member 521 is provided with a bending adjustment section 5212. Moreover, openings 5211 corresponding to the barbs 5221 are provided on the sleeve member 521. In the natural state, the sleeve member 521 is sleeved on the puncturing member 522. And the barbs 5221 on the puncturing member 522 are just arranged at the openings 5211 and tilt obliquely outwards. During loading, the control wire 523 passes through the connection holes (not shown) and is detachably connected with the other end of the sleeve member 521 by cooperation and clamping. At this time, the bending adjustment section 5212 bends, and the barbs 5221 are restricted inside the sleeve member 521. When the outer stent 1 is delivered to the mitral valve, first release the body of the outer stent 1 from the delivery tube. The operator observes the relative position of the outer stent 1 and the mitral valve through imaging. When adjusted to the ideal implantation position, the control wire 523 is withdrawn from the connection holes (not shown). The bending adjustment section 5212 resumes the preset shape and drives the puncturing member 522 to move, so that the barbs 5221 extend out from the openings 5211 and penetrate through the fabric layer 3 and pierce into the heart tissue. By adopting the above solution, multiple barbs 5221 on the anchoring component 52 can provide sufficient anchoring force for the valve prosthesis without relying on radially expanding the autologous valve annulus. Moreover, the barbs 5221 can be released after the stent is released and adjusted to the ideal implantation position, which can not only avoid unnecessary damage to the heart tissue, but also, the ideal implantation position reduces problems such as paravalvular leakage.

[0043] In this embodiment, in the natural state, the distance from the connection holes (not shown) to the other end of the sleeve member 521 is greater than or equal to the length of the barbs 5221. The purpose of such a design is to ensure that during loading, the barbs 5221 are completely compressed and restricted inside the sleeve member 521, and no part of the barbs 5221 will be exposed outside to cause damage to the heart tissue.

[0044] In this embodiment, a connection ring 511 and a limiting rod 512 are arranged inside the grid-type stent 51, as Figure 3As shown, the sleeve member 521 is fixedly connected to the connecting ring 511. One end of the limiting rod 512 is fixed inside the grid-shaped bracket 51, and the other end of the limiting rod 512 is free towards the lower end of the grid-shaped bracket 51. Moreover, one end of the limiting rod 512 is at the same height as the connecting ring 511, ensuring that the anchoring assembly 52 is in a horizontal state relative to the outer bracket 1.

[0045] In this embodiment, during pre-installation, the outer bracket 1 is compressed inside the delivery tube, and the sleeve member 521 and the puncturing member 522 are also in a straightened state, as Figure 8 shown, such a design is beneficial for loading and delivery.

[0046] In this embodiment, the stiffness of the bending section 5212 is less than that of the rest of the sleeve member 521. Keeping the sleeve member 521 stationary and pulling the puncturing member 522 can cause the bending section 5212 to bend, as Figure 4 shown. When the control wire 523 is withdrawn from the connection hole (not shown), the bending section 5212 will have a restoring force, as Figure 6 and Figure 7 shown, which can pull the puncturing member 522 to move relative to the sleeve member 521, causing the barbs 5221 to protrude from the opening 5211.

[0047] In this embodiment, both the sleeve member 521 and the puncturing member 522 are designed with a preset shape, and the preset shape matches the contour inside the grid-shaped bracket 51. When the outer bracket 1 is released, the sleeve member 521 and the puncturing member 522 will return to the preset shape along the inside of the outer bracket 1.

[0048] In this embodiment, the limiting rod 512 is an arc-shaped rod, as Figure 5 shown. When the outer bracket 1 is released, the anchoring assembly 52 returns to the preset shape along the inside of the outer bracket 1. Moreover, when the control wire 523 is withdrawn from the connection hole (not shown), since there is an upward pulling force when the control wire 523 is withdrawn from the connection hole (not shown), the limiting rod 512 can limit the movement of the anchoring assembly 52 towards the upper end of the outer bracket 1.

[0049] In this embodiment, the grid-shaped bracket 51 is composed of a plurality of diamond-shaped grids, and the opening 5211 of the sleeve member 521 is arranged in the middle area of the diamond-shaped grid. The purpose of such a design is to ensure that the barbs 5221 will not interfere with the outer bracket 1 when protruding, and ensure that the barbs 5221 can penetrate the fabric layer 3 and pierce into the heart tissue.

[0050] In this embodiment, there is more muscular tissue in the posterior leaflet region, while there is less muscular tissue in the anterior leaflet region and it is adjacent to the aortic blood vessel. Therefore, after the outer stent 1 is implanted, the anchoring section 5 is correspondingly arranged in the posterior leaflet region to provide sufficient anchoring force to ensure the position of the valve prosthesis in the heart. The adaptive section 6 is correspondingly arranged in the anterior leaflet region, and the anchoring assembly 52 is correspondingly arranged in the annulus region. Moreover, the barbs 5221 extend out from the opening 5211 and penetrate through the fabric layer 3 and pierce into the annulus tissue of the posterior leaflet region.

[0051] In this embodiment, the rigid strength of the anchoring section 5 is greater than that of the adaptive section 6. The adaptive section 6 includes a flexible framework 61 and a rhombic support structure 62 connected to the flexible framework 61. The left and right ends of the rhombic support structure 62 are respectively fixedly connected to the anchoring section 5. The purpose of such a design is that the anchoring section 5 is located in the posterior leaflet region, mainly to provide sufficient anchoring force. While the anterior leaflet region is adjacent to the aortic blood vessel and has less muscular tissue, which is not convenient for anchoring operations. Therefore, the adaptive section 6 is correspondingly arranged in the anterior leaflet region. After the outer stent 1 is implanted, the adaptive section 6 fits the autologous anterior annulus. Moreover, the adaptive section 6 can undergo adaptive deformation following the opening and closing of the autologous valve, so that the adaptive section 6 can always fit the autologous anterior annulus, which can not only ensure the anchoring effect of the valve stent but also avoid the problem of paravalvular leakage.

[0052] An exemplary operation process for repairing the mitral valve of a valve prosthesis for replacing the mitral valve in the first embodiment is as follows: 1. The system for delivering the valve prosthesis approaches through a transvascular approach, passes through the patient's atrial septum to reach the position of the left atrium, and first releases the outer stent 1 to observe the relative position between the outer stent 1 and the autologous mitral valve. 2. When the outer stent 1 is adjusted to a relatively ideal implantation position, the control wire 523 is withdrawn, and the bending section 5212 at one end of the sleeve member 521 returns to the preset shape and pulls the puncture member 522 to move within the sleeve member 521, so that each barb 5221 extends out from the opening 5211 of the sleeve member 521 and pierces through the fabric layer 3 and finally pierces into the annulus tissue of the posterior leaflet, as Figure 10 shown; 3. The inner stent 2 is delivered to the inside of the outer stent 1, the inner stent 2 is adjusted to a relatively central position, and released, as Figure 9 shown; 4. The system for delivering the valve prosthesis is withdrawn to complete the operation.

[0053] The foregoing description of the above embodiments of the present application has been presented for purposes of illustration. The foregoing description is not intended to be exhaustive nor to limit the present application to the precise configurations, constructions, and / or steps disclosed, and obviously, many modifications and variations are possible in light of the above teachings. The scope of the invention and all equivalents thereof are intended to be defined by the appended claims.

Claims

1. A valve prosthesis for replacing a mitral valve, comprising an outer stent and an inner stent, wherein the outer stent is coated with a fabric layer, and the inner stent is provided with an artificial valve leaflet, characterized in that: The external support includes an anchoring section and an adaptive section, and the anchoring section includes a grid-type support and an anchoring assembly connected to the grid-type support, wherein the anchoring assembly includes a sleeve member, a puncture member, and a control wire, and the puncture member is provided with a plurality of barbs that are tilted obliquely outward and a connecting hole, wherein the puncture member is arranged inside the sleeve member, one end of the puncture member is fixedly connected to one end of the sleeve member, and the sleeve member is provided with an opening corresponding to the barb, when the control wire passes through the connecting hole and cooperates with the other end of the sleeve member to realize a detachable connection, at this time, the barb is confined in the sleeve member; when the control wire is pulled out of the connecting hole, the barb extends from the opening and passes through the fabric layer and penetrates into the heart tissue.

2. A valve prosthesis for replacing a mitral valve according to claim 1, characterized in that: In a natural state, the distance from the connecting hole to the other end of the sleeve member is greater than or equal to the length of the barb.

3. A valve prosthesis for replacing a mitral valve according to claim 1, characterized in that: A connecting ring and a limiting rod are provided on the inner side of the grid-type bracket, the sleeve is fixedly connected to the connecting ring, one end of the limiting rod is fixed on the inner side of the grid-type bracket, and the other end of the limiting rod is free toward the lower end of the grid-type bracket.

4. A valve prosthesis for replacing a mitral valve according to claim 1, characterized in that: A bending section is provided at one end of the sleeve member. When the control wire passes through the connecting hole and cooperates with the other end of the sleeve member to achieve a detachable connection, the bending section bends; when the control wire is pulled out of the connecting hole, the bending section restores the preset shape and drives the puncture member to move, so that the barb extends from the opening and passes through the fabric layer and pierces the heart tissue.

5. A valve prosthesis for replacing a mitral valve according to claim 1, characterized in that: The sleeve member and the puncture member are both designed with a preset shape, and the preset shape matches the contour of the inner side of the grid-type stent.

6. A valve prosthesis for replacing a mitral valve according to claim 3, characterized in that: The limiting rod is an arc-shaped rod. When the outer bracket is released, the anchor assembly recovers to a preset shape along the inner side of the outer bracket, and when the control wire is pulled out of the connecting hole, the limiting rod can limit the anchor assembly from moving toward the upper end of the outer bracket.

7. A valve prosthesis for replacing a mitral valve according to claim 1, characterized in that: The grid-type bracket is composed of a plurality of rhombus-shaped grids, and the opening of the sleeve member is arranged in the middle area of ​​the rhombus-shaped grids.

8. A valve prosthesis for replacing a mitral valve according to claim 1, characterized in that: After the external stent is implanted, the anchoring segment is correspondingly arranged in the posterior valve area, the adaptive segment is correspondingly arranged in the anterior valve area, the anchoring assembly is correspondingly arranged in the valve ring area, and the barbs extend from the opening and penetrate through the fabric layer into the valve ring tissue in the posterior valve area.

9. A valve prosthesis for replacing a mitral valve according to claim 8, characterized in that: The rigidity strength of the anchoring segment is greater than the rigidity strength of the adaptive segment.

10. A valve prosthesis for replacing a mitral valve according to claim 9, characterized in that: The adaptive segment includes a flexible skeleton and a rhombus-shaped support structure connected to the flexible skeleton. The left and right ends of the rhombus-shaped support structure are respectively fixedly connected to the anchoring segment. After the external stent is implanted, the adaptive segment fits the native anterior valve ring, and the adaptive segment can adaptively deform following the opening and closing of the native valve, so that the adaptive segment can always fit the native anterior valve ring.

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