Double-orifice mitral valve replacement implant

Abstract

Provided in the present application is a double-orifice mitral valve replacement implant, which comprises a cloth-covered outer stent and an inner valve stent. The cloth-covered outer stent is sleeved around the periphery of the inner valve stent. The inner valve stent comprises a first inner stent and a second inner stent arranged side by side, and a first biological valve and a second biological valve are arranged in the first inner stent and the second inner stent, respectively. An accommodating gap is formed among the cloth-covered outer stent, the first inner stent, and the second inner stent. A flow blocking skirt is arranged in the accommodating gap, one side of the flow blocking skirt is connected to an inner wall of the cloth-covered outer stent, and the other side is attached to peripheries of the first inner stent and the second inner stent. A tightening thread is threaded through an edge of the flow blocking skirt close to the first inner stent or the second inner stent. The present application effectively solves the problems of paravalvular leakage and leakage through a fitting gap between an inner stent and an outer stent, thereby exhibiting high safety.

Description

A double-port mitral valve replacement implant Technical Field

[0001] This application belongs to the field of medical device technology and relates to a double-port mitral valve replacement implant. Background Technology

[0002] Transcatheter mitral valve replacement (TCVPR) is an interventional procedure that replaces a diseased or abnormal mitral valve with an artificial one. Mitral valves are typically large, and the individual mitral valves used in traditional replacements are correspondingly larger, with increased valve height and a greater portion entering the left ventricle. This poses risks of obstructing the left ventricular outflow tract and entanglement of the chordae tendineae. Furthermore, commonly used mitral valve replacement products are usually designed in a cylindrical shape, while the mitral valve's spatial structure is saddle-shaped and D-shaped in planar plane. This mismatch between the saddle-shaped valve and the cylindrical valve can lead to gaps and a higher risk of paravalvular leakage.

[0003] CN109009568A discloses a mitral valve prosthesis, a tricuspid valve prosthesis, and a stent thereof. The stent includes an inflow tract, a transition region, and an outflow tract along the axial direction. The two ends of the transition region are connected to the inflow tract and the outflow tract, respectively. In the deployed state, the inflow tract is located upstream of the outflow tract in the blood flow direction. The radial stiffness of the inflow tract is less than that of the outflow tract and / or the transition region. Its shape can better adapt to the original mitral valve annulus shape, reduce the compression and interference to the aortic valve, and thus reduce the risk of left ventricular outflow tract obstruction.

[0004] CN116138931A discloses a mitral valve artificial interventional valve, comprising: a main stent with a circular upper opening and an elliptical lower opening; two imaging elements symmetrically arranged on opposite sides of the upper opening of the main stent, with their axial direction parallel or perpendicular to the short axis of the lower opening of the elliptical main stent; and anchoring elements symmetrically arranged on the short axis of the lower elliptical cross-section of the main stent, configured to anchor the mitral valve artificial interventional valve to the mitral valve position in the human body. The imaging elements can clearly indicate the axial direction of the artificial valve stent, and the anchoring elements can accurately position themselves to clamp the leaflet in the central area of ​​the mitral valve leaflet, reducing the pushing on the anterior leaflet of the mitral valve, thereby minimizing left ventricular outflow tract obstruction.

[0005] CN108578016A discloses a transapical mitral valve implantation device, comprising: an outer valve stent, which includes an outer valve stent body and an anchoring unit. The outer valve stent body is composed of a plurality of first structural units arranged circumferentially. The anchoring unit is used to anchor the mitral valve device in the body. The inner and / or outer surfaces of the outer valve stent body are covered with an outer skirt; an inner valve stent, which is disposed inside the outer valve stent and interconnected with the outer valve stent, forming a cavity between the outer valve stent and the inner valve stent; and a leaflet structure disposed inside the inner valve stent to form an artificial valve, which can ensure that the bioprosthetic valve is not affected by the irregular contour of the diseased mitral valve and always maintains an ideal shape contour.

[0006] However, the existing mitral valve has a relatively high overall valve height, which still cannot completely avoid the problem of obstructing the left ventricular outflow tract. Furthermore, its leak prevention design has always been a pain point in the industry. Since peripheral valve leakage is an important reference indicator in the clinical evaluation process, further improvements are needed in the leak prevention design of the mitral valve. Summary of the Invention

[0007] This application provides a dual-port mitral valve replacement implant that effectively solves the problems of paravalvular leakage and leakage in the fit gap between the internal and external stents, thereby improving the safety and effectiveness of the dual-port mitral valve artificial heart valve.

[0008] This application provides a dual-port mitral valve replacement implant, which includes a fabric-covered outer support and an inner valve support. The fabric-covered outer support is sleeved on the outer periphery of the inner valve support. The inner valve support includes a first inner support and a second inner support arranged side by side, and a first bioprosthetic valve and a second bioprosthetic valve are respectively disposed in the first inner support and the second inner support. An accommodating gap is formed between the fabric-covered outer support, the first inner support, and the second inner support. A flow-blocking skirt is disposed in the accommodating gap. One side of the flow-blocking skirt is connected to the inner wall of the fabric-covered outer support, and the other side is fitted to the outer periphery of the first inner support and the second inner support. A tightening thread passes through the edge of the flow-blocking skirt near the edge of the first inner support or the second inner support.

[0009] The mitral valve replacement implant provided in this application has a dual-hole structure, which effectively reduces the overall height of the valve. At the same time, the gap between the external and internal stents is sealed with a flow-blocking skirt to prevent leakage. The flow-blocking skirt is tightly fitted to the two internal stents by the tightening lines that converge with each other, which effectively solves the problem of paravalvular leakage.

[0010] It should be noted that the accommodating gap refers to the space formed by the inner wall of the outer support, the outer wall of the first inner support, and the outer wall of the second inner support.

[0011] As a preferred technical solution of this application, the flow-blocking skirt has a first edge and a second edge, the first edge being close to the first inner support, the second edge being close to the second inner support, and the tightening line passing through the junction of the first edge and the second edge.

[0012] The flow-blocking skirt can be a split structure or an integrated structure.

[0013] The flow-blocking skirt is stitched to the inner wall of the outer fabric support.

[0014] As a preferred technical solution of this application, the first inner support and the second inner support are independently cylindrical or arc-shaped.

[0015] The accommodating gap includes a first gap and a second gap that are triangular in shape.

[0016] The flow-blocking skirt includes a first flow-blocking portion and a second flow-blocking portion located within the first gap and the second gap, respectively.

[0017] The first flow-blocking part and the second flow-blocking part are independent of each other or connected to each other.

[0018] Two tightening lines are independently threaded through the first edge and the second edge of the first flow-blocking part and the second flow-blocking part, respectively.

[0019] That is, in this application, the first edge and the second edge of the first flow-blocking part are respectively provided with two tightening lines, and the first edge and the second edge of the second flow-blocking part are respectively provided with two tightening lines. Through the mutual tightening of the four tightening lines, the first flow-blocking part and the second flow-blocking part are respectively independently and tightly attached to the first inner support and the second inner support.

[0020] As a preferred technical solution of this application, the fabric-covered outer support includes an outer main support, a first skirt and a second skirt; the outer main support is sleeved on the outer periphery of the inner valve stent, the outer main support has an inflow end and an outflow end, the first skirt covers the outer surface of the inflow end, and the second skirt covers the inner surface of the outflow end.

[0021] It should be noted that, in this application, the inflow end refers to the end from which blood flows into the outer support of the fabric, and the outflow end refers to the end from which blood flows out of the outer support of the fabric.

[0022] As a preferred technical solution of this application, the outer main body support includes a flange portion and a main body portion arranged sequentially from the inflow end to the outflow end. The main body portion is cylindrical and is sleeved on the outer periphery of the first inner support and the second inner support. The flange portion is arranged circumferentially along the main body portion and is folded away from the central axis of the main body portion.

[0023] The first skirt hem is stitched to the outer wall of the flange.

[0024] The second skirt hem is sewn to the inner wall of the main body.

[0025] In this application, the flange of the outer main stent is matched with the structure of the left atrium to fit the left atrium and avoid circumferential leakage. The main body extends into the left ventricle and adopts a nested design with the two internal stents, which greatly shortens the overall height of the valve and avoids obstructing the outflow tract of the left ventricle.

[0026] As a preferred technical solution of this application, the inner wall of the main body is provided with at least two support rods, which are bent toward the central axis of the main body and fit against the flow-blocking skirt.

[0027] The support rod is connected to the main body by stitching, bonding, bolting, snap-fitting, riveting, pinning, or heat fusion.

[0028] The support struts in this application provide internal support for the flow-blocking skirt, thereby improving the structural strength of the flow-blocking skirt and further preventing gap leakage.

[0029] As a preferred technical solution of this application, the first skirt, the second skirt, and the flow-blocking skirt are all woven.

[0030] The weaving density of the flow-blocking skirt is greater than that of the first skirt and the second skirt.

[0031] The materials of the first skirt, the second skirt, and the flow-blocking skirt are independently carbon fiber, polyethylene, polytetrafluoroethylene, silk, polypropylene, or polyester.

[0032] As a preferred technical solution of this application, the thickness of the flow-blocking skirt is greater than the thickness of the first skirt and the second skirt, respectively.

[0033] As a preferred technical solution of this application, the first bioprosthetic valve and the second bioprosthetic valve each independently include a valve skirt and at least three leaflets disposed within the valve skirt, the leaflets being sutured to the valve skirt.

[0034] The valve skirt is sutured to the first internal stent or the second internal stent.

[0035] As a preferred technical solution of this application, the first inner support and the second inner support are connected by stitching or riveting.

[0036] Compared with the prior art, the beneficial effects of this application are as follows:

[0037] This application provides a dual-hole mitral valve replacement implant that effectively reduces the overall height of the valve by having a dual-hole structure combined with a nested design of inner and outer stents. At the same time, a flow-blocking skirt is used to seal the gap between the outer and inner stents to prevent leakage, and the flow-blocking skirt is tightly fitted to the two inner stents by tightening lines that converge with each other, effectively solving the problem of paravalvular leakage. Attached Figure Description

[0038] Figure 1 is an exploded view of the double-port mitral valve replacement implant provided in the embodiment of this application.

[0039] Figure 2 is a schematic diagram of the combination of the cloth-covered external stent and the internal valve stent provided in the embodiment of this application.

[0040] Figure 3 is a schematic diagram of the structure of the external main body support provided in the embodiment of this application.

[0041] Figure 4 is a top view of the inflow end of the combination of the outer fabric-covered stent and the inner valve stent provided in the embodiment of this application.

[0042] Figure 5 is a schematic diagram of the flow-blocking skirt provided in an embodiment of this application.

[0043] Among them, 100-outer support with fabric covering; 10-first skirt; 20-flow-blocking skirt; 21-first flow-blocking part; 22-second flow-blocking part; 30-outer main body support; 31-first support rod; 32-second support rod; 33-main body; 34-flange part; 40-second skirt; 51-first inner support; 52-second inner support; 61-first valve skirt; 62-second valve skirt; 71-first leaflet; 72-second leaflet; 301-first gap; 302-second gap; 401-first tightening line; 402-second tightening line; 403-third tightening line; 404-fourth tightening line. Detailed Implementation

[0044] It should be understood that in the description of this application, the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. These terms are used solely for the convenience of describing this application and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this application, unless otherwise stated, "a plurality of" means two or more.

[0045] It should be noted that, in the description of this application, unless otherwise expressly specified and limited, the terms "set up," "connected," and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0046] The technical solution of this application will be further described below with reference to the accompanying drawings and specific embodiments.

[0047] In one specific embodiment, this application provides a dual-port mitral valve replacement implant, comprising a cloth-covered outer stent and an inner valve stent. The cloth-covered outer stent is fitted around the outer periphery of the inner valve stent. The inner valve stent includes a first inner stent and a second inner stent arranged side by side, with a first bioprosthetic valve and a second bioprosthetic valve respectively disposed within the first inner stent and the second inner stent. This application uses two side-by-side inner stents and their internal bioprosthetic valves as implants, reducing the overall height of the implant compared to traditional single mitral valve replacement, thus avoiding obstruction of the left ventricular outflow tract. A receiving gap is formed between the cloth-covered outer stent, the first inner stent, and the second inner stent. A flow-blocking skirt is provided within the receiving gap. One side of the flow-blocking skirt is connected to the inner wall of the cloth-covered outer stent, and the other side is fitted against the outer periphery of the first inner stent and the second inner stent. A tightening thread passes through the edge of the flow-blocking skirt near the edge of the first inner stent or the second inner stent. The flow-blocking skirt is used to close the gaps between the outer fabric support and the first inner support and the second inner support, respectively. The tightening lines that converge make the flow-blocking skirt fit tightly with the two inner supports, thereby closing the gap between the first inner support and the second inner support, effectively solving the problems of perivalvular leakage and gap leakage.

[0048] In some embodiments, the fabric-covered outer support includes an outer main body support, a first skirt, and a second skirt. The outer main body support is fitted around the outer periphery of the inner valve stent, and has an inflow end and an outflow end. The first skirt covers the outer surface of the inflow end, and the second skirt covers the inner surface of the outflow end. Specifically, the outer main body support includes a flange portion and a main body portion arranged sequentially from the inflow end to the outflow end. The main body portion is cylindrical and fits around the outer periphery of the first and second inner stents. The flange portion is arranged circumferentially along the main body portion and folded away from the central axis of the main body portion. The first skirt portion is sewn to the outer wall of the flange portion, and the second skirt portion is sewn to the inner wall of the main body portion.

[0049] The main body is a hollow metal cylindrical frame with a grid structure, which can be made of nickel-titanium alloy, cobalt-chromium alloy, or stainless steel. To reduce the gap between the outer support, the first inner support, and the second inner support, the cross-sectional shape of the main body can be elliptical or D-shaped. Any shape is acceptable as long as it can enclose the two inner supports and perfectly match their structures; this application does not impose specific limitations on this. The shape of the grid includes, but is not limited to, rhombuses, pentagons, or hexagons. Furthermore, the outer peripheral wall of the main body can also be provided with several anchoring parts along the circumferential direction, including but not limited to barbs or hooks well known to those skilled in the art, to improve the stability of the implant.

[0050] The flange portion is arranged circumferentially along the main body and smoothly folds outward, extending at a certain angle to the central axis of the main body. This provides good conformability, allowing it to be anchored to the original tissue first, improving the fit between the external stent and the left atrial contour. The flange portion can consist of several flange pieces, spaced apart circumferentially along the main body. Adjacent flange pieces can be independent or interconnected. The shapes of the flange pieces include, but are not limited to, rod-shaped, Y-shaped, rhomboid, triangular, pentagonal, or hexagonal shapes.

[0051] Furthermore, the inner wall of the main body is provided with at least two support rods. These support rods are bent towards the central axis of the main body and conform to the end face of the flow-blocking skirt near the flange. The support rods are connected to the main body by stitching, bonding, bolting, snap-fitting, riveting, pinning, or heat fusion. The shape of the support rods can be rod-shaped, triangular, Y-shaped, T-shaped, or rhomboid, etc. The support rods are made of biocompatible metal materials, including but not limited to nickel-titanium alloys or cobalt-chromium alloys.

[0052] In some embodiments, the first and second bioprosthetic valves each independently include a valve skirt and at least three leaflets disposed within the valve skirt, the leaflets being sutured to the valve skirt. The valve skirt is sutured to the first or second internal stent. The leaflets may be made of animal pericardial material, including but not limited to porcine or bovine pericardial material well known to those skilled in the art.

[0053] The first inner support and the second inner support are connected by stitching or riveting to reduce the gap between them and prevent leakage. Both the first and second inner supports are hollow metal cylindrical frames with a grid structure, and can be made of nickel-titanium alloy, cobalt-chromium alloy, or stainless steel.

[0054] In some embodiments, the flow-blocking skirt has a first edge and a second edge, the first edge being close to the first inner support and the second edge being close to the second inner support, with the tightening line extending from the junction of the first edge and the second edge. During application, the tightening line is pulled tight, causing the first edge of the flow-blocking skirt to fit snugly against the outer periphery of the first inner support and the second edge of the flow-blocking skirt to fit snugly against the outer periphery of the second inner support, thereby sealing the gaps inside the inner support.

[0055] The tightening line is tightened at the junction of the first edge and the second edge to eliminate the gap between the first inner support and the second inner support. The tightening line can be a single line that passes through the first edge and the second edge in sequence, or it can be two lines that are respectively set on the first edge and the second edge. This application does not make a specific limitation in this regard.

[0056] The flow-blocking skirt can be a split structure or an integrated structure. Depending on the specific structure and fit of the outer fabric support, the first inner support, and the second inner support, the accommodating gap can include multiple parts, such as the space formed by the inner wall of the outer fabric support, the outer walls of the first and second inner supports, etc. Specifically, it could be a triangular space formed by the left inner wall of the outer fabric support, the left outer wall of the first inner support, and the left outer wall of the second inner support; a triangular space formed by the right inner wall of the outer fabric support, the right outer wall of the first inner support, and the right outer wall of the second inner support; an arc-shaped space formed by the front inner wall of the outer fabric support and the front outer wall of the first inner support; an arc-shaped space formed by the rear inner wall of the outer fabric support and the rear outer wall of the second inner support; etc. However, to reduce the gap and ensure a perfect match between the outer fabric support, the first inner support, and the second inner support, the outline shape of the outer fabric support can usually be adjusted so that its front inner wall is tightly fitted against the front outer wall of the first inner support, and its rear inner wall is tightly fitted against the rear outer wall of the second inner support. The flow-blocking skirt, based on the specific shape of the accommodating gap, can be composed of multiple parts, each of which can be connected or independent. The flow-blocking skirt is sewn to the inner wall of the outer fabric support.

[0057] Specifically, when the first inner support and the second inner support are independently cylindrical or arc-shaped, the front inner wall and rear inner wall of the fabric-covered outer support are respectively tightly fitted to the front outer wall of the first inner support and the front outer wall of the second support, thereby forming accommodating gaps including a first gap and a second gap in the shape of triangles. The first gap is the space formed by the inner wall of the fabric-covered outer support, the outer wall of the first inner support, and the outer wall of the second inner support located on the same side; the second gap is the space formed by the inner wall of the fabric-covered outer support, the outer wall of the first inner support, and the outer wall of the second inner support located on the other side. The flow-blocking skirt includes a first flow-blocking part and a second flow-blocking part located in the first gap and the second gap respectively. The first flow-blocking part and the second flow-blocking part also have a triangular structure, and the first flow-blocking part and the second flow-blocking part are independent of each other or connected to each other. A tightening thread passes through the first edge of the first flow-blocking portion to fit tightly against one side of the outer wall of the first inner support, and a tightening thread passes through the second edge to fit tightly against one side of the outer wall of the second inner support. Similarly, a tightening thread passes through the first edge of the second flow-blocking portion to fit tightly against the other side of the outer wall of the first inner support, and a tightening thread passes through the second edge to fit tightly against the other side of the outer wall of the second inner support. All tightening threads extend from the junction of the first and second edges to facilitate tightening operations, ensuring that the first and second flow-blocking portions fit tightly against the first and second inner supports, respectively.

[0058] In some embodiments, the first skirt, the second skirt, and the flow-blocking skirt are all woven, and the weaving density of the flow-blocking skirt is greater than that of the first skirt and the second skirt. The weaving density of the first skirt and the second skirt may be the same or different; this application does not specifically limit this. The materials of the first skirt, the second skirt, and the flow-blocking skirt independently include carbon fiber, polyethylene, polytetrafluoroethylene, silk, polypropylene, or polyester. Further, the thickness of the flow-blocking skirt is greater than that of the first skirt and the second skirt. The thickness of the first skirt and the second skirt may be the same or different; this application does not specifically limit this.

[0059] Example

[0060] This embodiment provides a dual-port mitral valve replacement implant, including a fabric-covered external stent 100 and an internal valve stent. As shown in Figures 1 and 2, the internal valve stent includes a cylindrical first internal stent 51 and a second internal stent 52, which are sutured together. A first bioprosthetic valve and a second bioprosthetic valve are respectively disposed within the first internal stent 51 and the second internal stent 52. The first bioprosthetic valve includes a first valve skirt 61 and three first leaflets 71 disposed within the first valve skirt 61, which are sutured to the inner surface of the first valve skirt 61. The second bioprosthetic valve includes a second valve skirt 62 and three second leaflets 72 disposed within the second valve skirt 62, which are sutured to the inner surface of the second valve skirt 62.

[0061] As shown in Figures 1, 3, and 4, the fabric-covered outer support 100 includes an outer main support 30, a first skirt 10, and a second skirt 40. The outer main support 30 has an inflow end and an outflow end, and is formed by a flange portion 34 and a main body portion 33 arranged sequentially from the inflow end to the outflow end. The main body portion 33 is cylindrical and is fitted around the outer periphery of the first inner support 51 and the second inner support 52. The flange portion 34 is arranged circumferentially along the main body portion 33 and is folded away from the central axis of the main body portion 33. The first skirt 10 is circumferentially sewn to the outer wall of the flange portion 34, and the second skirt 40 is circumferentially sewn to the inner wall of the main body portion 33.

[0062] A receiving gap is formed between the inner wall of the main body 33, the outer wall of the first inner support 51, and the outer wall of the second inner support 52, and a flow-blocking skirt 20 is provided within the receiving gap. The first skirt 10, the second skirt 40, and the flow-blocking skirt 20 are all woven from carbon fiber, and the first skirt 10 and the second skirt 40 have the same weaving density, while the flow-blocking skirt 20 has a higher weaving density than the first skirt 10 and the second skirt 40. At the same time, the first skirt 10 and the second skirt 40 have the same thickness, while the flow-blocking skirt 20 has a greater thickness than the first skirt 10 and the second skirt 40.

[0063] As shown in Figure 4, the accommodating gap includes a first gap 301 and a second gap 302, both triangular in shape. The first gap 301 is formed by the left inner wall of the main body 33, the left outer wall of the first inner support 51, and the left outer wall of the second inner support 52. The second gap 302 is formed by the right inner wall of the main body 33, the right outer wall of the first inner support 51, and the right outer wall of the second inner support 52. As shown in Figure 5, the flow-blocking skirt 20 adopts an integral structure, including a first flow-blocking part 21 and a second flow-blocking part 22 connected to each other. Both the first flow-blocking part 21 and the second flow-blocking part 22 are triangular in shape. The first flow-blocking part 21 is disposed within the first gap 301. The outer edge of the first flow-blocking part 21 is stitched to the left inner wall of the main body 33. Its first edge is close to the left outer wall of the first inner support 51, and its second edge is close to the left outer wall of the second inner support 52. A first tightening thread 401 passes through the first edge, and a second tightening thread 402 passes through the second edge. The first tightening thread 401 and the second tightening thread 402 independently exit from the junction of the first edge and the second edge. The outer edge of the second flow-blocking part 22 is stitched to the right inner wall of the main body 33. Its first edge is close to the right outer wall of the first inner support 51, and its second edge is close to the right outer wall of the second inner support 52. A third tightening thread 403 passes through the first edge, and a fourth tightening thread 404 passes through the second edge. The third tightening thread 403 and the fourth tightening thread 404 independently exit from the junction of the first edge and the second edge. As shown in Figure 3, a first support rod 31 and a second support rod 32 are disposed opposite each other on the inner wall of the main body 33. The first support rod 31 and the second support rod 32 are bent independently toward the central axis of the main body 33 and respectively fit into the first flow-blocking part 21 and the second flow-blocking part 22. The first support rod 31 and the second support rod 32 are connected to the main body 33 by a pin.

[0064] In this embodiment, the first bioprosthetic valve and the second bioprosthetic valve are first fixed inside the first inner stent 51 and the second inner stent 52, respectively, while the flow-blocking skirt 20 is sewn and fixed to the outer fabric support 100. Then, the first inner stent 51 and the second inner stent 52, which carry the first bioprosthetic valve and the second bioprosthetic valve, are placed inside the outer fabric support 100 and tightened together by the first tightening line 401, the second tightening line 402, the third tightening line 403 and the fourth tightening line 404, so as to achieve a tight fit between the flow-blocking skirt 20, the first inner stent 51 and the second inner stent 52. Subsequently, the entire implant is delivered into the target position in the body using a delivery device to replace the original valve.

[0065] The applicant declares that the above description is only a specific implementation of this application, but the protection scope of this application is not limited thereto. Those skilled in the art should understand that any changes or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application fall within the protection and disclosure scope of this application.

Claims

1. A dual-orifice mitral valve replacement implant comprising an outer cloth-covered stent and an inner valve stent, wherein, The outer support of the fabric is sleeved on the outer periphery of the inner valve stent. The inner valve stent includes a first inner stent and a second inner stent arranged side by side. The first inner stent and the second inner stent are respectively provided with a first bioprosthetic valve and a second bioprosthetic valve. A receiving gap is formed between the outer fabric support, the first inner support, and the second inner support. A flow-blocking skirt is provided in the receiving gap. One side of the flow-blocking skirt is connected to the inner wall of the outer fabric support, and the other side is fitted to the outer periphery of the first inner support and the second inner support. A tightening line is passed through the edge of the flow-blocking skirt near the edge of the first inner support or the second inner support.

2. The dual-orifice mitral replacement implant of claim 1, wherein, The flow-blocking skirt has a first edge and a second edge, the first edge being close to the first inner support and the second edge being close to the second inner support, and the tightening line passing through the junction of the first edge and the second edge; The flow-blocking skirt can be a split structure or an integrated structure; The flow-blocking skirt is stitched to the inner wall of the outer fabric support.

3. The dual-orifice mitral replacement implant of claim 2, wherein, The first inner support and the second inner support are independently cylindrical or arc-shaped; The accommodating gap includes a first gap and a second gap that are triangular in shape; The flow-blocking skirt includes a first flow-blocking portion and a second flow-blocking portion located respectively within the first gap and the second gap; The first flow-blocking part and the second flow-blocking part are independent of each other or connected to each other; Two tightening lines are independently threaded through the first edge and the second edge of the first flow-blocking part and the second flow-blocking part, respectively.

4. The dual-orifice mitral replacement implant of claim 1, wherein, The fabric-covered outer support includes an outer main support, a first skirt, and a second skirt; The outer main body support is sleeved on the outer periphery of the inner valve support. The outer main body support has an inflow end and an outflow end. The first skirt covers the outer surface of the inflow end, and the second skirt covers the inner surface of the outflow end.

5. The dual-orifice mitral replacement implant of claim 4, wherein, The outer main body support includes a flange portion and a main body portion arranged sequentially from the inflow end to the outflow end. The main body portion is cylindrical and is sleeved on the outer periphery of the first inner support and the second inner support. The flange portion is arranged circumferentially along the main body portion and is folded away from the central axis of the main body portion. The first skirt hem is sewn to the outer wall of the flange portion; The second skirt hem is sewn to the inner wall of the main body.

6. The dual-orifice mitral replacement implant of claim 5, wherein, The inner wall of the main body is provided with at least two support rods, which are bent toward the central axis of the main body and fit against the flow-blocking skirt. The support rod is connected to the main body by stitching, bonding, bolting, snap-fitting, riveting, pinning, or heat fusion.

7. The dual-orifice mitral replacement implant of claim 4 or 5, wherein, The first skirt edge, the second skirt edge, and the flow-blocking skirt edge are all woven together; The weaving density of the flow-blocking skirt is greater than that of the first skirt and the second skirt, respectively; The materials of the first skirt, the second skirt, and the flow-blocking skirt are independently carbon fiber, polyethylene, polytetrafluoroethylene, silk, polypropylene, or polyester.

8. The dual-orifice mitral replacement implant of claim 7, wherein, The thickness of the flow-blocking skirt is greater than the thickness of the first skirt and the second skirt, respectively.

9. The dual-orifice mitral replacement implant of claim 1, wherein, The first biological valve and the second biological valve each independently comprise a valve skirt and at least three leaflets arranged in the valve skirt, the leaflets being sutured to the valve skirt; The valve skirt is sutured to the first inner stent or the second inner stent.

10. The dual-orifice mitral replacement implant of claim 1, wherein, The first inner stent and the second inner stent are sutured or riveted.

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