Mitral valve device and method of use

Abstract

The present invention relates to the field of medical device technology, and in particular to a mitral valve device and a method of use, comprising a stent and a leaflet, wherein the stent comprises an outer stent and an inner stent, and the outer stent is sewed flexibly through a suture membrane to sew a flexible connection, wherein the upper end of the outer stent comprises an outward expansion frame for being placed at the atrial end, and a lower end barrel-shaped frame receiving the upper end and extending from the atrial end to the ventricle through the valve ring, wherein one side of the outward expansion frame has a highly raised atrial wall fitting surface; the outer peripheral side of the barrel-shaped frame has a plurality of raised structures near the valve ring; the inner stent is cylindrical, and the leaflet is sutured in the inner stent through a clip; the end of the stent has a tightening structure, and the tightening structure is connected to an anchor through a drawstring. The mitral valve device of the present invention and a method of use thereof can better adapt to the anatomical structure of the heart through a double-layer stent structure and an asymmetric outer stent, reduce the influence of heart movement on the inner stent and the leaflet, ensure the effectiveness of the device, and extend the use time of the device.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a mitral valve device and a use method thereof. Background Art

[0002] The mitral valve is located between the left atrium and the left ventricle, like a one-way valve, ensuring that blood flows from the left atrium to the left ventricle and passes a certain flow rate. The mitral valve complex is a group of devices with complex functions and anatomical structures, which are generally considered to include the valve ring, valve leaflets, chordae tendineae and papillary muscles. The function of the mitral valve depends on the integrity of its physiological structure. When the normal mitral valve is closed, the two valve leaflets are in the same plane and closely align, which can completely block the backflow of ventricular blood flow. To achieve this effect, the mitral valve ring must be of appropriate size, the valve leaflet structure must be intact, the papillary muscle contraction must pull the chordae tendineae to support the valve leaflet, the closing force generated by the contraction of the left ventricular muscle must be appropriate, and the ventricular morphology and function must be normal. When the mitral valve complex structure is damaged or the heart is damaged, mitral regurgitation will occur.

[0003] Compared with surgical valve replacement, the surgical trauma, risks, and long-term and expensive rehabilitation treatment after surgery make a large number of patients unwilling to undergo surgery. Transcatheter heart valve therapy provides doctors with a new treatment method with less trauma, fewer complications, and faster postoperative recovery. For example, the patent with publication number CN104302247A discloses a prosthetic heart valve that is deployed in sequence, which includes a self-expanding frame, which has an atrial skirt, a ventricular skirt, and an annular area arranged therebetween. The first front ear is arranged on the front of the frame. The rear ear is located on the rear of the self-expanding frame. The frame can be designed so that any part can be expanded in sequence in any desired order. For example, a part of the first front ear and a part of the rear ear can first be partially self-expanded. Next, the first front ear can be fully self-expanded before the rear ear is fully self-expanded. Next, the rear ear can be fully self-expanded, followed by the ventricular skirt; or next, the ventricular skirt can be self-expanded, followed by the rear ear. Full expansion. Although this technical solution can solve some technical problems in the manufacturing of atrioventricular valve stents, due to the particularity of the mitral valve structure, the mitral valve interventional valve is difficult to implant and difficult to fix after implantation. In practical applications, it still faces many problems, such as the problem of fixing the valve in situ, the valve is not well matched with the physiological structure of the heart, which easily causes paravalvular leakage, damage to the ventricle and subvalvular structure, and part of the valve is compressed by the native tissue, affecting blood flow.

[0004] In view of the above technical problems, it is necessary to improve them. Summary of the invention

[0005] The purpose of the present invention is to provide a mitral valve device and a method of use thereof in view of the defects of the prior art.

[0006] In order to achieve the above purpose, the present invention adopts the following technical solutions:

[0007] A mitral valve device, comprising a stent and a leaflet, wherein the stent comprises an outer stent and an inner stent; the surfaces of the outer stent and the inner stent are bonded with suture membranes, and the outer stent and the inner stent are flexibly connected by suturing the suture membranes; the outer stent comprises an outward expansion frame at an upper end for being placed at an atrial end, and a lower barrel-shaped frame receiving the upper end and extending from the atrial end to the ventricle through the valve ring; the outward expansion frame has an inwardly concave outward expansion shape, which is adapted to the shape of the atrial end near the valve ring, and one side of the outward expansion frame has a highly convex atrial wall fitting surface, and the atrial wall fitting surface is adapted to the shape of the atrial wall surface; the outer peripheral side of the barrel-shaped frame has a plurality of convex structures near the valve ring, and a clamping surface is formed between the convex structure and the outward expansion frame; the inner stent is columnar, and the valve leaflet is sutured to the inner stent by a clip; the end of the stent has a tightening structure, and the tightening structure is connected to an anchor by a drawstring.

[0008] Preferably, the outwardly expanded frame and the barrel-shaped frame have a concave structure adapted to the valve ring at the valve ring position at the receiving portion.

[0009] Preferably, the angle between the atrial wall fitting surface of the outward expansion frame on the side close to the cardiac outflow tract and the horizontal plane is greater than or equal to 30 degrees.

[0010] Preferably, the outer layer bracket and the inner layer bracket are mesh structures, and the mesh structure is formed by one or more methods of cutting, welding, and weaving; the number of grid layers of the outward expansion frame and the barrel-shaped bracket in the inner layer bracket and the outer layer bracket are single-layer or multi-layer, respectively, and the number of grids in one grid layer is 3-30 grids.

[0011] Preferably, the numbers of grids in each grid layer of the outward expansion frame and the barrel-shaped bracket in the inner layer bracket and the outer layer bracket are the same or different.

[0012] Preferably, the support is made of self-expanding memory alloy, and the support wall thickness is 0.1-1 mm.

[0013] Preferably, the diameter of the outward expansion frame is 20-120 mm, and the height is 5-80 mm; the diameter of the barrel-shaped frame is 15-60 mm, and the height is 5-60 mm.

[0014] Preferably, the inner layer support has a diameter of 15-45 mm and a height of 12-45 mm.

[0015] Preferably, the outer stent has a radiopaque indicator.

[0016] Preferably, the inner layer stent has an inner stent suture hole, the leaflets and the clips are passed through the inner stent suture hole and are sewed to the inner layer stent, and the inner stent suture hole is circular or polygonal in shape.

[0017] Preferably, the leaflet comprises a suture ear, a free edge, and a suture edge, and the suture ear and the clip are sutured by sutures; the leaflet is made of biological material and / or polymer material; and the leaflet has a thickness of 0.1-1 mm.

[0018] Preferably, the clip has suture holes, the number of which is 1-6; the clip material is any one or more of polymer materials, biomaterials, and metal materials.

[0019] Preferably, the suture membrane includes an outer suture membrane, an inner suture membrane, and a connecting membrane. The outer suture membrane is sutured to the outer side of the outer layer bracket by sutures, the inner suture membrane is sutured to the inner side of the inner layer bracket by sutures, and the connecting membrane is sutured from the inner upper part of the outer layer bracket to the inner upper part of the inner layer bracket by sutures; the suture membrane material is one or more of PET, polyurethane, PTFE, and e-PTFE; the suture membrane thickness is 0.01-1mm.

[0020] Preferably, the diameter of the suture is 0.01-0.8 mm; the material of the suture is one or more of polymer materials PET, PTFE, e-PTFE, biological tissue, and tissue engineering materials.

[0021] Preferably, the tightening structure is connected to the bottom of the barrel-shaped frame of the outer support, the height of the tightening structure is 3-50 mm, and the diameter after tightening is 1-10 mm.

[0022] Preferably, there is an auxiliary flexible connection and / or rigid connection between the outer layer support and the inner layer support to assist in fixing the outer layer support and the inner layer support.

[0023] Preferably, the number of the pull ropes is 1-20; the diameter of the pull ropes is 0.05-4 mm; and the material of the pull ropes is a polymer material or biological tissue.

[0024] Preferably, the anchor is anchored at the outside of the apex; the diameter of the anchor is 3-30 mm; the thickness of the anchor is 0.1-5 mm; the material of the anchor is one or more of polymer materials, biological tissues, and metals.

[0025] Preferably, the outer peripheral protrusion structure of the barrel-shaped frame is an arc-shaped protrusion.

[0026] A method for using a mitral valve device comprises the steps of:

[0027] S1, receiving the mitral valve device in the lumen of the delivery device, and puncturing the apex or atrium to the target position through the delivery device;

[0028] S2, releasing the outward expansion frame of the outer stent of the mitral valve device delivered to the target position through the delivery device and pulling the delivery system of the delivery device so that the outward expansion frame is closely attached to the atrium side of the valve;

[0029] S3, releasing the barrel-shaped frame of the outer stent so that the barrel-shaped frame is closely attached to the valve annulus;

[0030] S4, release the tightened structure;

[0031] S5, adjusting the positioning by pulling the drawstring through the conveying device;

[0032] S6, adjust the length of the pull rope, release the anchor when it reaches the apex and anchor it at the apex;

[0033] S7, evacuate the conveying device.

[0034] Preferably, a method for using a mitral valve device comprises the steps of:

[0035] S1, placing the mitral valve device in a lumen of a delivery device, and passing the delivery device through a blood vessel or the right atrium into the left atrium;

[0036] S2, reaching the apex of the heart, releasing the anchor through the delivery device and anchoring it at the apex of the heart;

[0037] S3, release the drawstring, adjust the drawstring length and tighten the drawstring;

[0038] S4, releasing the tightening structure, the barrel frame, and the outward expansion frame in sequence to the target position;

[0039] S5, evacuate the conveying device.

[0040] Compared with the prior art, a mitral valve device and a method of using the same of the present invention reduce the impact of heart movement on the inner stent and leaflets through a double-layer stent structure, thereby ensuring the effectiveness of the device and extending the use time of the device; in addition, the asymmetric outer stent can better adapt to the anatomical structure of the heart and effectively reduce paravalvular leakage. The raised structure of the outer stent can better fix the valve, the tightening structure reduces blood flow obstruction, and the anchor is firmly positioned. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1 This is a schematic diagram of the overall structure of the mitral valve device according to the first embodiment of the present invention;

[0042] Figure 2 This is a schematic diagram of the outer stent structure of the mitral valve device according to the first embodiment of the present invention;

[0043] Figure 3 It is a schematic top view of the outer stent structure of the mitral valve device according to the first embodiment of the present invention;

[0044] Figure 4 This is a schematic diagram of the inner stent structure of the mitral valve device according to the first embodiment of the present invention;

[0045] Figure 5 It is a schematic top view of the inner stent structure of the mitral valve device according to the first embodiment of the present invention;

[0046] Figure 6 This is a schematic structural diagram of an inner stent, a suture membrane, and a leaflet of a mitral valve device according to Embodiment 1 of the present invention;

[0047] Figure 7 This is a schematic diagram of the clip structure of the mitral valve device according to the first embodiment of the present invention;

[0048] Figure 8 This is a schematic diagram of the outer suture membrane structure of the suture membrane of the mitral valve device according to the first embodiment of the present invention;

[0049] Fig. 9 This is a schematic structural diagram of an inner suture membrane of a suture membrane of a mitral valve device according to Embodiment 1 of the present invention;

[0050] Fig.10 This is a schematic structural diagram of a connection membrane of a suture membrane of a mitral valve device according to Embodiment 1 of the present invention;

[0051] Fig.11 This is a schematic diagram of the leaflet structure of the mitral valve device according to the first embodiment of the present invention;

[0052] Fig.12 This is a schematic diagram of the mitral valve device according to the first embodiment of the present invention after being implanted into the heart;

[0053] Fig.13 This is a schematic diagram of a method for using the mitral valve device according to the first embodiment of the present invention;

[0054] Fig.14 This is a schematic diagram of a method for using the mitral valve device according to the second embodiment of the present invention;

[0055] Fig.15 This is a schematic diagram of the outer stent structure of the mitral valve device according to the third embodiment of the present invention;

[0056] Fig.16 This is a schematic diagram of the inner stent structure of the mitral valve device according to the fourth embodiment of the present invention;

[0057] Fig.17 This is a schematic diagram of the outer stent structure of the mitral valve device according to the fifth embodiment of the present invention;

[0058] Fig.18 This is a schematic diagram of the structure of an anchoring member of a mitral valve device according to a sixth embodiment of the present invention;

[0059] Fig.19 This is a schematic diagram of the structure of an anchoring member of a mitral valve device according to a sixth embodiment of the present invention;

[0060] Fig. 20 This is a schematic diagram of the structure of an anchoring member of a mitral valve device according to a sixth embodiment of the present invention;

[0061] Among them: 1. mitral valve device; 2. outer layer stent; 2-1. outward expansion frame; 2-2. barrel-shaped frame; 2-3. tightening structure; 2-2-1. protruding structure; 3. inner layer stent; 3-1. stent suture hole; 4. clip; 5. suture membrane; 5-1. outer suture membrane; 5-2. inner suture membrane; 5-3. connecting membrane; 6. leaflet; 6-1. suture ear; 6-2. suture edge; 6-3. free edge; 7. pull rope; 8. anchor. DETAILED DESCRIPTION

[0062] The following describes the embodiments of the present invention by specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the following embodiments and features in the embodiments can be combined with each other without conflict.

[0063] Embodiment 1:

[0064] like Figure 1-13As shown, the mitral valve device 1 of this embodiment includes a stent and a leaflet 6. The stent includes an outer stent 2 and an inner stent 3. The outer stent 2 protects the inner stent 3 and limits the movement of the valve in the heart after it is released. The surfaces of the outer stent 2 and the inner stent 3 are bonded with a suture membrane 5, and the outer stent 2 and the inner stent 3 are flexibly connected by suturing the suture membrane 5. The outer stent 2 includes an outer expansion frame 2-1 at the upper end for being placed at the atrial end, and a lower barrel frame 2-2 connected to the upper end for extending from the atrial end to the ventricle through the valve ring. The outer expansion frame 2-1 has a concave outer expansion shape, and the concave structure can fit the aortic surface and match the shape of the atrial end near the valve ring. One side of the outer expansion frame 2-1 has a highly convex atrial wall fitting surface. The atrial wall fitting surface is adapted to the shape of the atrial wall; the outer peripheral side of the barrel-shaped frame 2-2 is provided with a plurality of protruding structures 2-2-1 near the valve ring, and a clamping surface is formed between the protruding structure 2-2-1 and the outward expansion frame 2-1, and the clamping surface can cooperate with the entire outer layer stent 2 to fix the device to enhance stability. Preferably, the protruding structure 2-2-1 on the outer peripheral side of the barrel-shaped frame 2-2 is an arc-shaped protrusion, which can reduce the damage to the ventricular subvalvular structure, and at the same time plasticize the internal structure, reduce the compression of the valve by the original composition, and reduce the influence of blood flow; the inner layer stent 3 is columnar, and the leaflet 6 is sutured to the inner layer stent 3 by the clip 4 to replace the original valve; the end of the stent is provided with a tightening structure 2-3, and the tightening structure 2-3 is connected to the anchor 8 by a pull rope 7 for anchoring the stent.

[0065] Specifically, the diameter of the outer expansion frame 2-1 is 20-120mm, the height is 5-80mm, the diameter of the barrel-shaped frame 2-2 is 15-60mm, the height is 5-60mm, and this size is more suitable for the structural size of the normal heart. The outer expansion frame 2-1 and the barrel-shaped frame 2-2 have a concave structure adapted to the valve ring at the valve ring position at the receiving part, and the concave structure helps the outer layer stent 2 to fit the target position and reduce the damage of abnormal mechanical force to the target area; further, the angle between the atrial wall fitting surface of the outer expansion frame 2-1 near the heart outflow tract and the horizontal plane is greater than or equal to 30 degrees. Due to its asymmetric shape, the outer layer stent 2 can better adapt to the anatomical structure of the heart, effectively reduce paravalvular leakage, and fit the atrial wall better. The appropriate inclination angle can adapt to the pressure and fit of the atrial wall and enhance stability. Preferably, the outer layer stent 2 also has a radiopaque indicator to facilitate the positioning of the device during surgery.

[0066] The diameter of the inner stent 3 is selected to be 15-45mm, and the height is selected to be 12-45mm, which is more suitable for the size of a normal heart. The inner stent 3 is provided with an inner stent suture hole 3-1, and the leaflet 6 and the clip 4 are sewn to the inner stent 3 through the inner stent suture hole 3-1. The inner stent suture hole 3-1 is not limited in shape and can be circular or polygonal. The clip 4 has an adaptive suture hole, and the number is preferably 1-6 for optimal use and manufacturing; the material of the clip 4 is selected from any one or more of polymer materials, biomaterials, and metal materials. The clip 4 may also not have a suture hole, and directly penetrate the material for suture to enhance the sealing. The leaflet 6 includes a suture ear 6-1, a free edge 6-3, and a suture edge 6-2. The suture ear 6-1 and the clip 4 are sutured by suture thread; the leaflet 6 is a biomaterial and / or a polymer material; the leaflet 6 is preferably 0.1-1mm thick for optimal strength and toughness.

[0067] The outer layer bracket 2 and the inner layer bracket 3 are both mesh structures, and the mesh structure is formed by one or more methods including cutting, welding and weaving. The bracket material is selected from self-expanding memory alloy, such as nickel-titanium, nickel-titanium-based, copper-based, iron-based and other shape memory alloys. When the bracket wall thickness is 0.1-1mm, the strength and toughness performance are optimal; the mesh shape is not limited to square shape, Z shape, diamond shape, etc.; the number of mesh layers of the inner layer bracket 3 and the outer layer bracket 2, the outward expansion frame 2-1, and the barrel-shaped bracket can be single-layer or multi-layer, the number of layers can be the same or different, and the number of meshes in each layer can also be the same or different. The number of mesh layers or grids is not limited. Preferably, the number of meshes in a mesh layer is 3-30, and the mesh manufacturing and use performance is optimal.

[0068] The suture membrane 5 includes an outer suture membrane 5-1, an inner suture membrane 5-2, and a connecting membrane 5-3. The outer suture membrane 5-1 is sutured to the outer side of the outer stent 2 by sutures, the inner suture membrane 5-2 is sutured to the inner side of the inner stent 3 by sutures, and the connecting membrane 5-3 is sutured from the inner upper part of the outer stent 2 to the inner upper part of the inner stent 3 by sutures; the suture membrane 5 material is one or more of PET, polyurethane, PTFE, and e-PTFE; the suture membrane 5 thickness is preferably 0.01-1mm for best strength and toughness. The suture diameter is preferably 0.01-0.8mm, with good use and manufacturing performance; the suture material is selected from one or more of polymer materials PET, PTFE, e-PTFE, biological tissue, and tissue engineering materials.

[0069] The tightening structure 2-3 is connected to the bottom of the barrel frame 2-2 of the outer support 2. The height of the tightening structure 2-3 is preferably 3-50mm, and the diameter after tightening is set to 1-10mm. This size has little effect on the internal structure of the heart. The tightening structure 2-3 can be mesh-shaped or strip-shaped, and can be integrally woven or welded or woven with the outer support 2, which can reduce the obstruction of the artificial heart valve to the blood entering the aorta and reduce turbulence; the tightening structure 2-3 is connected to the anchor 8 through a pull rope 7. The direction and number of the pull rope 7 are not limited. Preferably, the number of pull ropes 7 is 1-20, and the diameter of the pull rope 7 is 0.05-4mm, which has strong applicability; the material of the pull rope 7 is selected from polymer materials or biological tissues; the anchor 8 is anchored on the outside of the apex using a barbed anchor. The diameter of the anchor 8 is preferably 3-30mm and the thickness is 0.1-5mm for best size adaptability. The material is not limited and can be selected from one or more of polymer materials, biological tissues, and metals.

[0070] In order to enhance the overall stability of the device after implantation, the outer stent 2 and the inner stent 3 are also provided with auxiliary flexible connections and / or rigid connections to assist in fixing the outer stent 2 and the inner stent 3. Flexible connections include wire connections and braided connections. Rigid connections include partial welding or riveting of the inner stent 3 and the lower end of the barrel-shaped frame 2-2. The flexible connection combined with the support of the partial rigid connection can buffer the impact of heart beating on the inner stent 3 and the leaflets 6, while enhancing the stability of the overall device after implantation in the heart, ensuring its effectiveness and extending the use time.

[0071] To use, follow these steps:

[0072] S1, the mitral valve device 1 is stored in the lumen of the delivery device, and is punctured to the apex or atrium to the target position through the delivery device;

[0073] S2, releasing the outward expansion frame 2-1 of the outer stent 2 of the mitral valve device 1 delivered to the target position through the delivery device and pulling the delivery system of the delivery device so that the outward expansion frame 2-1 is closely attached to one side of the valve atrium;

[0074] S3, releasing the barrel-shaped frame 2-2 of the outer stent 2, so that the barrel-shaped frame 2-2 is closely attached to the valve annulus;

[0075] S4, release the tightening structure 2-3;

[0076] S5, adjust the positioning by pulling the pull rope 7 of the conveying device, that is, when the release process encounters inaccurate positioning and needs to be repositioned, the device structure can be pulled back to the conveying device by pulling the pull rope 7 and repositioned.

[0077] S6, adjusting the length of the pull rope 7, releasing the anchor 8 when it reaches the apex and anchoring it at the apex. The anchoring part can be fixed by embedding or suturing, and the position can be a suitable position such as the outer side of the apex;

[0078] S7, evacuate the conveying device.

[0079] The mitral valve device 1 and the method of using the same in this embodiment are provided with an apex anchor 8 which can be firmly positioned at the target position in the heart; the double-layer stent structure can reduce the influence of cardiac movement on the inner stent 3 and the valve leaflets 6, thereby ensuring the effectiveness of the device and extending the service life of the device; in addition, the asymmetric outer stent 2 can better adapt to the anatomical structure of the heart and effectively reduce paravalvular leakage. The raised structure 2-2-1 of the outer stent 2 can better fix the valve, and the tightening structure 2-3 can reduce the obstruction of the artificial heart valve to the blood entering the aorta.

[0080] Embodiment 2:

[0081] The difference between the method of using the mitral valve device of this example and that of the embodiment is that:

[0082] like Fig.14 As shown, the following steps are included:

[0083] S1, placing the mitral valve device in a lumen of a delivery device, and passing the delivery device through a blood vessel or the right atrium into the left atrium;

[0084] S2, reaching the apex of the heart, releasing the anchor through the delivery device and anchoring it at the apex of the heart;

[0085] S3, release the drawstring, adjust the drawstring length and tighten the drawstring;

[0086] S4, releasing the tightening structure, the barrel frame, and the outward expansion frame in sequence to the target position;

[0087] S5, evacuate the conveying device.

[0088] Compared with the first embodiment, the conveying path of the conveying device is not limited, and the device has greater universality.

[0089] For other structures, please refer to Example 1.

[0090] Embodiment three:

[0091] The mitral valve device of this embodiment is different from that of the first embodiment in that:

[0092] like Fig.15 As shown, the tightening structure of this embodiment has a smaller contraction opening and performs incomplete contraction. Compared with the first embodiment, it can improve the toughness of the device and further reduce blood flow resistance.

[0093] For other structures, please refer to Example 1.

[0094] Embodiment 4:

[0095] The mitral valve device of this embodiment is different from that of the first embodiment in that:

[0096] like Fig.16 As shown, the tightening structure of this embodiment is connected to the bottom of the inner stent. Compared with the first embodiment, this design can reduce the tensile effect on the outer stent during heartbeat and enhance the implant stability of the device. Preferably, the tightening structure is connected to the inner stent or the outer stent with an arc to avoid damage to the internal structure of the heart.

[0097] For other structures, please refer to Example 1.

[0098] Embodiment five:

[0099] The mitral valve device of this embodiment is different from that of the first embodiment in that:

[0100] like Fig.17 As shown, the protrusion structure on the peripheral side of the barrel-shaped frame of the outer layer support in this embodiment is in the shape of a barb. Compared with the first embodiment, the shape of the protrusion structure on the peripheral side is not limited. The barb-shaped protrusion can penetrate into the target position while forming a clamping surface to further stabilize the device. The protrusion structure can also be a combination of arc-shaped protrusions, barb-shaped protrusions, or other shapes that can form a clamping surface, such as a straight bar.

[0101] For other structures, please refer to Example 1.

[0102] Embodiment six:

[0103] The mitral valve device of this embodiment is different from that of the first embodiment in that:

[0104] like Figure 18-20 As shown, the anchor of this example can be a threaded anchor, a gasket anchor or an anchor composed of a gasket and a barb. Compared with the first embodiment, the form of the anchor is not limited, and the threaded anchor is more convenient to anchor and release after implantation; the gasket anchor, the gasket can be placed outside the apex, and the length of the pull rope can be adjusted; the gasket and barb combined anchor, the gasket can be placed outside the apex, and the barb can be placed inside the myocardium to enhance the anchoring effect.

[0105] For other structures, please refer to Example 1.

[0106] The specific embodiments described herein are merely examples of the spirit of the present invention. Those skilled in the art may make various modifications or additions to the specific embodiments described or replace them in similar ways, but they will not deviate from the spirit of the present invention or exceed the scope defined by the appended claims.

Claims

1. A mitral valve device, comprising a stent and a valve leaflet, characterized in that: The stent comprises an outer stent and an inner stent; the surfaces of the outer stent and the inner stent are adhered with suture membranes, and the outer stent and the inner stent are flexibly connected by suturing the suture membranes; the outer stent comprises an outward expansion frame at the upper end for being placed at the atrial end, and a lower barrel-shaped frame receiving the upper end for extending the atrial end to the ventricle through the valve ring; the outward expansion frame has an inwardly concave outward expansion shape, which is adapted to the shape of the atrial end near the valve ring, and one side of the outward expansion frame has a highly convex atrial wall fitting surface, and the atrial wall fitting surface is adapted to the shape of the atrial wall surface; the outer peripheral side of the barrel-shaped frame has a plurality of convex structures near the valve ring, and a clamping surface is formed between the convex structure and the outward expansion frame; the inner stent is columnar, and the valve leaflet is sutured to the inner stent by a clip; the end of the stent has a tightening structure, and the tightening structure is connected to an anchor by a drawstring; The outward expansion frame and the barrel-shaped frame have a concave structure adapted to the valve ring at the valve ring position at the receiving part; The outer peripheral protrusion structure of the barrel-shaped frame is an arc-shaped protrusion; The suture membrane includes an outer suture membrane, an inner suture membrane, and a connecting membrane. The outer suture membrane is sutured to the outer side of the outer layer support by sutures, the inner suture membrane is sutured to the inner side of the inner layer support by sutures, and the connecting membrane is sutured from the inner upper part of the outer layer support to the inner upper part of the inner layer support by sutures; the suture membrane material is one or more of PET, polyurethane, PTFE, and e-PTFE; the suture membrane thickness is 0.01-1mm.

2. A mitral valve device according to claim 1, characterized in that: The angle between the atrial wall fitting surface of the outward expansion frame and the horizontal plane is greater than or equal to 30 degrees.

3. A mitral valve device according to claim 2, characterized in that: The outer layer bracket and the inner layer bracket are mesh structures, and the mesh structure is formed by one or more methods of cutting, welding, and weaving; the number of grid layers of the outward expansion frame and the barrel-shaped bracket in the inner layer bracket and the outer layer bracket are single-layer or multi-layer, and the number of grids in one grid layer is 3-30 grids.

4. A mitral valve device according to claim 3, characterized in that: The number of grids in each grid layer of the outward expansion frame and the barrel-shaped bracket in the inner layer bracket and the outer layer bracket is the same or different.

5. A mitral valve device according to claim 1, characterized in that: The support is made of self-expanding memory alloy, and the support wall thickness is 0.1-1 mm.

6. A mitral valve device according to claim 1, characterized in that: The diameter of the outward expansion frame is 20-120 mm, and the height is 5-80 mm; the diameter of the barrel-shaped frame is 15-60 mm, and the height is 5-60 mm.

7. A mitral valve device according to claim 1, characterized in that: The inner layer support has a diameter of 15-45 mm and a height of 12-45 mm.

8. The mitral valve device according to claim 1, characterized in that: The outer stent has a radiopaque indicator.

9. The mitral valve device according to claim 1, characterized in that: The inner layer support is provided with an inner support suture hole, and the leaflets and the clips are sewed on the inner layer support through the inner support suture hole, and the inner support suture hole is circular or polygonal in shape.

10. The mitral valve device according to claim 1, characterized in that: The leaflet comprises a suture ear, a free edge and a suture edge, and the suture ear and the clip are sutured by suture thread; the leaflet is made of biological material and / or polymer material; and the leaflet has a thickness of 0.1-1 mm.

11. A mitral valve device according to claim 10, characterized in that: The clip has 1-6 suture holes; the clip material is any one or more of polymer materials, biological materials, and metal materials.

12. The mitral valve device according to claim 1, characterized in that: The diameter of the suture is 0.01-0.8 mm; the material of the suture is one or more of PET, PTFE, e-PTFE, and biological tissue.

13. A mitral valve device according to claim 12, characterized in that: The tightening structure is connected to the bottom of the barrel-shaped frame of the outer support, the height of the tightening structure is 3-50 mm, and the diameter after tightening is 1-10 mm.

14. A mitral valve device according to claim 13, characterized in that: The outer layer support and the inner layer support also have an auxiliary flexible connection and / or rigid connection to assist in fixing the outer layer support and the inner layer support.

15. A mitral valve device according to claim 14, characterized in that: The number of the pull ropes is 1-20; the diameter of the pull ropes is 0.05-4 mm; and the material of the pull ropes is a polymer material or biological tissue.

16. The mitral valve device according to claim 1, characterized in that: The anchor is anchored at the outside of the apex; the diameter of the anchor is 3-30 mm; the thickness of the anchor is 0.1-5 mm; the material of the anchor is one or more of polymer materials, biological tissues, and metals.

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