A double-hole mitral valve replacement implant

Abstract

The present invention provides a double-hole mitral valve replacement implant, comprising a cloth-wrapped outer stent and an inner valve stent, wherein the cloth-wrapped outer stent is sleeved on the outer periphery of the inner valve stent, and the inner valve stent comprises a first inner stent and a second inner stent arranged side by side, wherein the first inner stent and the second inner stent are respectively provided with a first biological valve and a second biological valve; an accommodation gap is formed between the cloth-wrapped outer stent, the first inner stent and the second inner stent, and a flow-blocking skirt is provided in the accommodation gap, one side of the flow-blocking skirt is connected to the inner wall of the cloth-wrapped outer stent, and the other side is fittedly arranged on the outer periphery of the first inner stent and the second inner stent, and a tightening line is passed through the edge of the flow-blocking skirt close to the first inner stent or the second inner stent. The present invention effectively solves the problems of paravalvular leakage and leakage of the matching gap between the inner and outer stents, and has high safety.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices and relates to a double-hole mitral valve replacement implant. Background Art

[0002] Transcatheter mitral valve replacement is an interventional procedure that replaces the original diseased or abnormal mitral valve with an artificial mitral valve. The mitral valve is usually large in size, and the size of the single mitral valve used in traditional replacement is also correspondingly large, the valve height also increases, and more of it enters the left ventricle, posing the risk of obstructing the left ventricular outflow tract and entanglement of the chordae tendineae. In addition, commonly used mitral valve replacement products are usually designed to be cylindrical, while the spatial structure of the mitral valve is saddle-shaped and D-shaped in plane. It cannot be completely matched with the cylindrical valve and there is a gap, which makes it easy to have paravalvular leakage.

[0003] CN109009568A discloses a mitral valve prosthesis, a tricuspid valve prosthesis and a stent thereof, wherein the stent includes an inflow duct, a transition region and an outflow duct along the axial direction, wherein the two ends of the transition region are respectively connected to the inflow duct and the outflow duct; in the expanded state, the inflow duct is located upstream of the blood flow direction of the outflow duct, and the radial stiffness of the inflow duct is smaller than the radial stiffness of the outflow duct and / or the transition region, and its shape can better adapt to the shape of the native mitral valve ring, reduce the pressure and interference on the aortic valve, and thereby reduce the risk of left ventricular outflow duct obstruction.

[0004] CN116138931A discloses an artificial mitral valve intervention valve, which includes: a main body support, whose upper opening is circular and whose lower opening is elliptical; two developing elements symmetrically arranged on opposite sides of the upper opening of the main body support, and whose axial direction is parallel or perpendicular to the extension direction of the short axis of the lower opening of the elliptical main body support; anchoring members symmetrically arranged on the short axis of the elliptical cross-section of the lower section of the main body support, and configured to anchor the artificial mitral valve intervention valve to the mitral valve position of the human body, and the axial direction of the artificial valve support can be clearly indicated by the developing elements, and the anchoring members can be accurately positioned in the central area of ​​the mitral valve leaflet to clamp the leaflet, thereby reducing the pushing on the anterior leaflet of the mitral valve, thereby minimizing the left ventricular outflow tract obstruction.

[0005] CN108578016A discloses a transapical implantable mitral valve device, which includes: 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 along the circumferential direction, the anchoring unit is used to anchor the mitral valve device in the body, and the inner surface and / or outer surface of the outer valve stent body is covered with an outer skirt; an inner valve stent, which is arranged inside the outer valve stent and is interconnected with the outer valve stent, and a cavity is formed between the outer valve stent and the inner valve stent; a leaflet structure is arranged inside the inner valve stent to form an artificial valve, which can ensure that the biological valve prosthesis is not affected by the irregular contour of the diseased mitral valve and always maintains an ideal external contour.

[0006] However, the overall height of the existing mitral valve is relatively high, and it still cannot completely avoid the problem of blocking the left ventricular outflow tract. In addition, its leak-proof design has always been a design pain point in the industry, and paravalvular leakage is an important reference indicator in the clinical evaluation process. Therefore, the leak-proof design of the mitral valve needs to be further improved. Summary of the invention

[0007] In view of the deficiencies in the prior art, the purpose of the present invention is to provide a double-hole mitral valve replacement implant, which effectively solves the problems of paravalvular leakage and leakage in the fitting gap between the inner and outer stents, and improves the safety and effectiveness of the double-hole mitral valve artificial heart valve.

[0008] To achieve this object, the present invention adopts the following technical solutions:

[0009] The present invention provides a double-hole mitral valve replacement implant, which comprises a cloth-wrapped outer stent and an inner valve stent, wherein the cloth-wrapped outer stent is sleeved on the outer periphery of the inner valve stent, and the inner valve stent comprises a first inner stent and a second inner stent arranged side by side, wherein a first biological valve and a second biological valve are respectively arranged in the first inner stent and the second inner stent; an accommodating gap is formed between the cloth-wrapped outer stent, the first inner stent and the second inner stent, and a flow-blocking skirt is arranged in the accommodating gap, wherein one side of the flow-blocking skirt is connected to the inner wall of the cloth-wrapped outer stent, and the other side is fittedly arranged on the outer periphery of the first inner stent and the second inner stent, and a tightening line is passed through the edge of the flow-blocking skirt close to the first inner stent or the second inner stent.

[0010] The mitral valve replacement implant provided by the present invention has a double-hole structure, which effectively reduces the overall height of the valve. At the same time, a flow-blocking skirt is used to seal the gap between the external support and the internal support to avoid leakage in the gap. The flow-blocking skirt and the two internal supports are tightly fitted by tightening lines that converge against each other, effectively solving the problem of paravalvular leakage.

[0011] It should be noted that the accommodating gap refers to the space formed by the inner wall of the cloth-wrapped outer bracket, the outer wall of the first inner bracket and the outer wall of the second inner bracket.

[0012] As a preferred technical solution of the present invention, the baffle skirt has a first edge and a second edge, the first edge is close to the first inner bracket, the second edge is close to the second inner bracket, and the tightening line passes through the junction of the first edge and the second edge.

[0013] The flow-blocking skirt is a split structure or an integrated structure.

[0014] The flow-blocking skirt is sewn and connected to the inner wall of the cloth-wrapped outer bracket.

[0015] As a preferred technical solution of the present invention, the first inner support and the second inner support are independently cylindrical or arc-shaped.

[0016] The accommodating gap includes a first gap and a second gap in a triangular shape.

[0017] The flow-blocking skirt includes a first flow-blocking portion and a second flow-blocking portion respectively located in the first gap and the second gap.

[0018] The first flow blocking portion and the second flow blocking portion are independent of each other or connected to each other.

[0019] Two tightening lines are independently passed through the first edge and the second edge of the first flow blocking portion and the second flow blocking portion, respectively.

[0020] That is, in the present invention, two tightening lines are respectively passed through the first edge and the second edge of the first baffle portion, and two tightening lines are respectively passed through the first edge and the second edge of the second baffle portion. By tightening the four tightening lines together, the first baffle portion and the second baffle portion are independently and tightly fitted to the first inner bracket and the second inner bracket.

[0021] As a preferred technical solution of the present invention, the cloth-wrapped outer stent includes an outer main body stent, a first skirt and a second skirt; the outer main body stent is sleeved on the outer periphery of the inner valve stent, the outer main body stent has an inflow end and an outflow end, the first skirt is covered on the outer surface of the inflow end, and the second skirt is covered on the inner surface of the outflow end.

[0022] It should be noted that the inflow end in the present invention refers to the end where blood flows into the cloth-wrapped outer stent, and the outflow end refers to the end where blood flows out of the cloth-wrapped outer stent.

[0023] As a preferred technical solution of the present invention, the outer main body bracket includes a flange portion and a main body portion which are arranged in sequence from the inlet end to the outlet end, the main body portion is cylindrical, and the main body portion is sleeved on the outer circumference of the first inner bracket and the second inner bracket, and the flange portion is arranged along the circumference of the main body portion and folded in the direction away from the central axis of the main body portion.

[0024] The first skirt is connected to the outer wall of the flange portion by sewing.

[0025] The second skirt is connected to the inner wall of the main body by sewing.

[0026] The flange of the outer main body stent in the present invention matches the left atrial structure to fit the left atrium to avoid peripheral leakage, and the main body extends into the left ventricle and adopts a mutually nested design with the two inner stents therein, which greatly shortens the overall height of the valve and avoids obstruction of the left ventricular outflow tract.

[0027] As a preferred technical solution of the present invention, at least two supporting pressure rods are provided on the inner wall of the main body, and the supporting pressure rods are bent in a direction close to the central axis of the main body and fit the flow-blocking skirt.

[0028] The support pressure rod is connected to the main body by sewing, bonding, bolting, snapping, riveting, latching or hot-melting.

[0029] The support pressure rod of the present invention provides internal support force for the flow-blocking skirt, thereby improving the structural strength of the flow-blocking skirt and further avoiding gap leakage.

[0030] As a preferred technical solution of the present invention, the first skirt, the second skirt and the flow-blocking skirt are all woven.

[0031] The weaving density of the flow-blocking skirt is respectively greater than the weaving density of the first skirt and the second skirt.

[0032] The materials of the first skirt, the second skirt and the flow-blocking skirt independently include carbon fiber, polyethylene, polytetrafluoroethylene, silk, polypropylene or polyester.

[0033] As a preferred technical solution of the present invention, the thickness of the flow-blocking skirt is respectively greater than the thickness of the first skirt and the second skirt.

[0034] As a preferred technical solution of the present invention, the first biological valve and the second biological valve independently include a valve skirt and at least three leaflets arranged in the valve skirt, and the leaflets are sutured and connected to the valve skirt.

[0035] The valve skirt is sutured to the first inner stent or the second inner stent.

[0036] As a preferred technical solution of the present invention, the first inner bracket is connected to the second inner bracket by suture or rivet.

[0037] Compared with the prior art, the present invention has the following beneficial effects:

[0038] The present invention provides a double-hole mitral valve replacement implant, which has a double-hole structure and a nested design of an inner bracket and an outer bracket, thereby effectively reducing the overall height of the valve; at the same time, a flow-blocking skirt is used to seal the gap between the outer bracket and the inner bracket to avoid leakage of the gap, and the flow-blocking skirt is closely fitted to the two inner brackets through mutually contracting tightening lines, thereby effectively solving the problem of paravalvular leakage. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 An exploded view of a double-hole mitral valve replacement implant provided in an embodiment of the present invention.

[0040] Figure 2 Schematic diagram of the combination of a cloth-wrapped outer stent and an inner valve stent provided in an embodiment of the present invention.

[0041] Figure 3 A schematic structural diagram of an outer main body support provided in an embodiment of the present invention.

[0042] Figure 4 A top view of the inflow end after the cloth-wrapped outer stent and the inner valve stent are combined according to an embodiment of the present invention.

[0043] Figure 5 A schematic diagram of the structure of a flow-blocking skirt provided in an embodiment of the present invention.

[0044] Among them, 100-cloth-wrapped outer bracket; 10-first skirt; 20-blocking skirt; 21-first blocking part; 22-second blocking part; 30-outer main body bracket; 31-first supporting pressure rod; 32-second supporting pressure rod; 33-main body; 34-flange; 40-second skirt; 51-first inner bracket; 52-second inner bracket; 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 DESCRIPTION

[0045] It should be understood that, in the description of the present invention, the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention. In addition, the terms "first", "second", etc. are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first", "second", etc. may explicitly or implicitly include one or more of the features. In the description of the present invention, unless otherwise specified, "multiple" means two or more.

[0046] It should be noted that in the description of the present invention, unless otherwise clearly specified and limited, the terms "disposed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood by specific circumstances.

[0047] The technical solution of the present invention is further described below with reference to the accompanying drawings and through specific implementation methods.

[0048] In a specific embodiment, the present invention provides a double-hole mitral valve replacement implant, comprising a cloth-wrapped outer stent and an inner valve stent, wherein the cloth-wrapped outer stent is sleeved on the outer periphery of the inner valve stent, and the inner valve stent comprises a first inner stent and a second inner stent arranged side by side, wherein the first inner stent and the second inner stent are respectively provided with a first biological valve and a second biological valve. The present invention adopts two inner stents arranged side by side and the biological valves therein as implants, which reduces the height of the overall implant and avoids obstruction of the outflow tract of the left ventricle compared with the traditional single mitral valve replacement. An accommodating gap is formed between the cloth-wrapped outer stent, the first inner stent and the second inner stent, and a flow-blocking skirt is arranged in the accommodating gap, one side of the flow-blocking skirt is connected to the inner wall of the cloth-wrapped outer stent, and the other side is arranged in a close fit to the outer periphery of the first inner stent and the second inner stent, and a tightening line is passed through the edge of the flow-blocking skirt close to the first inner stent or the second inner stent. The baffle skirt is used to close the matching gaps between the cloth-wrapped outer bracket and the first inner bracket and the second inner bracket respectively, and the baffle skirt is tightly fitted to the two inner brackets through the mutually contracted tightening lines, thereby closing the gap between the first inner bracket and the second inner bracket, effectively solving the problems of paravalvular leakage and interstitial leakage.

[0049] In some embodiments, the cloth-wrapped outer stent includes an outer main body stent, a first skirt and a second skirt; the outer main body stent is sleeved on the outer periphery of the inner valve stent, the outer main body stent has an inflow end and an outflow end, the first skirt is coated on the outer surface of the inflow end, and the second skirt is coated on the inner surface of the outflow end. Specifically, the outer main body stent includes a flange portion and a main body portion arranged in sequence from the inflow end to the outflow end, the main body portion is cylindrical, and the main body portion is sleeved on the outer periphery of the first inner stent and the second inner stent, the flange portion is arranged along the circumference of the main body portion, and is folded in a direction away from the central axis of the main body portion. The first skirt is sutured to connect the outer wall of the flange portion, and the second skirt is sutured to connect the inner wall of the main body portion.

[0050] 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. In order to reduce the gap between the cloth-wrapped outer bracket, the first inner bracket and the second inner bracket, the cross-sectional shape of the main body can be elliptical or "D"-shaped. As long as it can realize the two inner brackets enclosing the inside and completely matching the structure of the two inner brackets, any shape can be adopted, and the present invention does not make specific limitations on this. The shape of the grid includes but is not limited to rhombus, pentagon or hexagon, etc. In addition, the outer peripheral wall of the main body can also be provided with a plurality of 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.

[0051] The flange is arranged along the circumference of the main body, and is smoothly folded outward, extending at a certain angle with the central axis of the main body, having good compliance, and can be anchored on the native tissue first, thereby improving the fit between the external stent and the left atrium contour. The flange can be composed of a plurality of flange parts, which are arranged at intervals along the circumference of the main body, and two adjacent flange parts can be independent of each other and can be connected to each other. The shape of the flange part includes but is not limited to a rod shape, a Y shape, a rhombus shape, a triangle, a pentagon or a hexagon, etc.

[0052] Furthermore, the inner wall of the main body is provided with at least two support rods, and the support rods are bent in the direction close to the central axis of the main body and fit the end face of the flow-blocking skirt close to the flange. The support rods are connected to the main body by suture, adhesive, bolt, snap, rivet, pin or hot-melt. The shape of the support rods can be rod-shaped, triangular, Y-shaped, T-shaped or diamond-shaped, etc. The support rods are made of biocompatible metal materials, including but not limited to nickel-titanium alloy or cobalt-chromium alloy.

[0053] In some embodiments, the first biological valve and the second biological valve each independently include a valve skirt and at least three leaflets disposed in the valve skirt, and the leaflets are sutured to connect the valve skirt. The valve skirt is sutured to connect the first inner support or the second inner support. The material of the leaflets can be animal pericardial material, including but not limited to porcine pericardial material or bovine pericardial material known to those skilled in the art.

[0054] The first inner bracket and the second inner bracket are connected by suture or rivet to reduce the gap between the first inner bracket and the second inner bracket to avoid gap leakage. The first inner bracket and the second inner bracket are both hollow metal cylindrical frames with a grid structure, and can be made of nickel-titanium alloy, cobalt-chromium alloy or stainless steel.

[0055] In some embodiments, the flow-blocking skirt has a first edge and a second edge, the first edge is close to the first inner bracket, the second edge is close to the second inner bracket, and the tightening line passes through the intersection of the first edge and the second edge. During application, the tightening line is tightened so that the first edge of the flow-blocking skirt is closely attached to the outer periphery of the first inner bracket, and the second edge of the flow-blocking skirt is closely attached to the outer periphery of the second inner bracket, so as to close the gap inside the inner bracket.

[0056] The tightening line is tightened at the junction of the first edge and the second edge to eliminate the gap between the first inner bracket and the second inner bracket, and the tightening line can be a line passing through the first edge and the second edge in sequence, or it can be two lines respectively arranged at the first edge and the second edge, and the present invention does not make specific limitations on this.

[0057] The flow-blocking skirt is a split structure or an integrated structure. According to the specific structure and mutual matching degree of the cloth outer bracket, the first inner bracket and the second inner bracket, the accommodating gap may include multiple parts, such as the space formed by the inner wall of the cloth outer bracket, the outer wall of the first inner bracket and the outer wall of the second inner bracket, the space formed by the inner wall of the cloth outer bracket and the outer wall of the first inner bracket, the space formed by the inner wall of the cloth outer bracket and the outer wall of the second inner bracket, the space formed by the outer wall of the first inner bracket and the outer wall of the second inner bracket, etc. Specifically, the triangular space formed by the left inner wall of the cloth outer bracket, the left outer wall of the first inner bracket and the left outer wall of the second inner bracket, the triangular space formed by the right inner wall of the cloth outer bracket, the right outer wall of the first inner bracket and the right outer wall of the second inner bracket, the arc space formed by the front inner wall of the cloth outer bracket and the front outer wall of the first inner bracket, the arc space formed by the rear inner wall of the cloth outer bracket and the rear outer wall of the second inner bracket, etc. However, in order to reduce the gap and ensure that the cloth-wrapped outer bracket, the first inner bracket and the second inner bracket are fully matched, the contour shape of the cloth-wrapped outer bracket can usually be adjusted so that the front inner wall of the cloth-wrapped outer bracket is closely arranged with the front outer wall of the first inner bracket, and the rear inner wall of the cloth-wrapped outer bracket is closely arranged with the rear outer wall of the second inner bracket. The flow-blocking skirt can be composed of multiple parts based on the specific shape of the accommodating gap, and each part can be connected or independent of each other. The flow-blocking skirt is sewn to the inner wall of the cloth-wrapped outer bracket.

[0058] Specifically, when the first inner bracket and the second inner bracket are independently cylindrical or arc-shaped, the front inner wall and the rear inner wall of the cloth outer bracket are respectively arranged in close contact with the front outer wall of the first inner bracket and the front outer wall of the second bracket, so that the accommodation gap formed includes a triangular first gap and a second gap. The first gap is a space formed by the inner wall of the cloth outer bracket, the outer wall of the first inner bracket and the outer wall of the second inner bracket on the same side; the second gap is a space formed by the inner wall of the cloth outer bracket, the outer wall of the first inner bracket and the outer wall of the second inner bracket on the other side. The flow-blocking skirt includes a first flow-blocking part and a second flow-blocking part respectively located in the first gap and the second gap. 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 line is passed through the first edge of the first flow blocking part, which is used to closely fit the outer wall of one side of the first inner bracket, and a tightening line is passed through the second edge, which is used to closely fit the outer wall of one side of the second inner bracket; a tightening line is passed through the first edge of the second flow blocking part, which is used to closely fit the outer wall of the other side of the first inner bracket, and a tightening line is passed through the second edge, which is used to closely fit the outer wall of the other side of the second inner bracket. The tightening lines are passed through the junction of the first edge and the second edge to facilitate the tightening operation, so that the first flow blocking part and the second flow blocking part are closely fitted with the first inner bracket and the second inner bracket respectively.

[0059] 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 respectively greater than the weaving density of the first skirt and the second skirt. The weaving density of the first skirt may be the same as or different from the weaving density of the second skirt, and the present invention does not make specific limitations on 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 materials. Furthermore, the thickness of the flow-blocking skirt is respectively greater than the thickness of the first skirt and the second skirt. The thickness of the first skirt may be the same as or different from the thickness of the second skirt, and the present invention does not make specific limitations on this.

[0060] Example

[0061] This embodiment provides a double-hole mitral valve replacement implant, including a cloth-wrapped outer stent 100 and an inner valve stent. Figure 1 and Figure 2As shown, the inner valve stent includes a first inner stent 51 and a second inner stent 52 in a cylindrical shape, and the first inner stent 51 and the second inner stent 52 are sutured and connected. The first biological valve and the second biological valve are respectively arranged in the first inner stent 51 and the second inner stent 52. The first biological valve includes a first valve skirt 61, and three first leaflets 71 arranged in the first valve skirt 61, and the first leaflets 71 are sutured and connected to the inner surface of the first valve skirt 61. The second biological valve includes a second valve skirt 62, and three second leaflets 72 arranged in the second valve skirt 62, and the second leaflets 72 are sutured and connected to the inner surface of the second valve skirt 62.

[0062] like Figure 1 , Figure 3 and Figure 4 As shown, the cloth-wrapped outer bracket 100 includes an outer main bracket 30, a first skirt 10 and a second skirt 40. The outer main bracket 30 has an inflow end and an outflow end, and is formed by a flange portion 34 and a main body portion 33 arranged in sequence from the inflow end to the outflow end. The main body portion 33 is cylindrical and is sleeved on the outer periphery of the first inner bracket 51 and the second inner bracket 52. The flange portion 34 is arranged along the circumference of the main body portion 33 and is folded in a direction away from the central axis of the main body portion 33. The first skirt 10 is sewed and connected to the outer wall of the flange portion 34 along the circumferential direction, and the second skirt 40 is sewed and connected to the inner wall of the main body portion 33 along the circumferential direction.

[0063] An accommodating gap is formed between the inner wall of the main body 33, the outer wall of the first inner bracket 51 and the outer wall of the second inner bracket 52, and a flow-blocking skirt 20 is arranged in the accommodating gap. The first skirt 10, the second skirt 40 and the flow-blocking skirt 20 are all woven from carbon fiber, and the weaving density of the first skirt 10 and the second skirt 40 is the same, and the weaving density of the flow-blocking skirt 20 is greater than the weaving density of the first skirt 10 and the second skirt 40. At the same time, the thickness of the first skirt 10 and the second skirt 40 is the same, and the thickness of the flow-blocking skirt 20 is greater than the thickness of the first skirt 10 and the second skirt 40.

[0064] like Figure 4 As shown, the accommodating gap includes a triangular first gap 301 and a second gap 302. The first gap 301 is formed by the left inner wall of the main body 33, the left outer wall of the first inner bracket 51, and the left outer wall of the second inner bracket 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 bracket 51, and the right outer wall of the second inner bracket 52. Figure 5As shown, the flow-blocking skirt 20 adopts an integrated structure, including a first flow-blocking portion 21 and a second flow-blocking portion 22 connected to each other, and the first flow-blocking portion 21 and the second flow-blocking portion 22 are both triangular. The first flow-blocking portion 21 is arranged in the first gap 301. The outer edge of the first flow-blocking portion 21 is sutured and connected to the left inner wall of the main body 33, and the first edge is close to the left outer wall of the first inner bracket 51, and the second edge is close to the left outer wall of the second inner bracket 52. The first edge is penetrated by a first tightening line 401, and the second edge is penetrated by a second tightening line 402. The first tightening line 401 and the second tightening line 402 independently pass through the junction of the first edge and the second edge. The outer edge of the second flow blocking portion 22 is sewn to the right inner wall of the main body 33, and the first edge is close to the right outer wall of the first inner bracket 51, and the second edge is close to the right outer wall of the second inner bracket 52. The first edge is penetrated by a third tightening line 403, and the second edge is penetrated by a fourth tightening line 404. The third tightening line 403 and the fourth tightening line 404 independently pass through the junction of the first edge and the second edge. Figure 3 As shown, the inner wall of the main body 33 is provided with a first support rod 31 and a second support rod 32, and the first support rod 31 and the second support rod 32 are independently bent toward the direction close to the central axis of the main body 33, and are respectively attached to the first flow blocking portion 21 and the second flow blocking portion 22. The first support rod 31 and the second support rod 32 are connected to the main body 33 by a latch.

[0065] In this embodiment, the first biological valve and the second biological valve are first fixed inside the first inner stent 51 and the second inner stent 52 respectively, and the flow-blocking skirt 20 is sutured and fixed to the cloth-wrapped outer stent 100; then, the first inner stent 51 and the second inner stent 52 carrying the first biological valve and the second biological valve are placed inside the cloth-wrapped outer stent 100, and are tightened with each other 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 the effect of close fit between the flow-blocking skirt 20, the first inner stent 51 and the second inner stent 52; then, the entire implant is delivered to the target position in the body by using a delivery device to replace the native valve.

[0066] The applicant declares that the above is only a specific implementation mode of the present invention, but the protection scope of the present invention is not limited thereto. Those skilled in the art should understand that any changes or substitutions that can be easily thought of by those skilled in the art within the technical scope disclosed by the present invention shall fall within the protection scope and disclosure scope of the present invention.

Claims

1. A double-hole mitral valve replacement implant, characterized in that: The double-hole mitral valve replacement implant comprises a cloth-wrapped outer stent and an inner valve stent, wherein the cloth-wrapped outer stent is sleeved on the outer periphery of the inner valve stent, and the inner valve stent comprises a first inner stent and a second inner stent arranged side by side, wherein the first inner stent and the second inner stent are respectively provided with a first biological valve and a second biological valve; A accommodating gap is formed between the cloth-wrapped outer bracket, the first inner bracket and the second inner bracket, a flow-blocking skirt is arranged in the accommodating gap, one side of the flow-blocking skirt is connected to the inner wall of the cloth-wrapped outer bracket, and the other side is arranged in close contact with the outer periphery of the first inner bracket and the second inner bracket, a tightening line is passed through the edge of the flow-blocking skirt close to the first inner bracket or the second inner bracket, the flow-blocking skirt has a first edge and a second edge, the first edge is close to the first inner bracket, the second edge is close to the second inner bracket, the tightening line passes through the intersection of the first edge and the second edge, and when in use, the tightening line is tightened to make the first edge closely fit the outer periphery of the first inner bracket, and the second edge closely fit the outer periphery of the second inner bracket; The accommodating gap includes a first gap and a second gap in a triangular shape, and the flow blocking skirt includes a first flow blocking portion and a second flow blocking portion respectively located in the first gap and the second gap, so as to prevent gap leakage; The cloth-wrapped outer stent comprises an outer main body stent, a first skirt and a second skirt, wherein the outer main body stent is sleeved on the outer periphery of the inner valve stent, the outer main body stent has an inflow end and an outflow end, the first skirt is coated on the outer surface of the inflow end, and the second skirt is coated on the inner surface of the outflow end; The outer main body bracket includes a flange portion and a main body portion arranged in sequence from the inlet end to the outlet end. The inner wall of the main body is provided with at least two supporting pressure rods, and the supporting pressure rods are bent in a direction close to the central axis of the main body and fit the flow-blocking skirt to support the flow-blocking skirt.

2. The double-orifice mitral valve replacement implant according to claim 1, characterized in that: The flow-blocking skirt is a split structure or an integrated structure; The flow-blocking skirt is sewn and connected to the inner wall of the cloth-wrapped outer bracket.

3. The double-orifice mitral valve replacement implant according to claim 2, characterized in that: The first inner support and the second inner support are independently cylindrical or arc-shaped; The first flow blocking portion and the second flow blocking portion are independent of each other or connected to each other; Two tightening lines are independently passed through the first edge and the second edge of the first blocking portion and the second blocking portion, respectively.

4. The double-orifice mitral valve replacement implant according to claim 1, characterized in that: The main body is cylindrical, and is sleeved on the outer circumference of the first inner bracket and the second inner bracket. The flange is arranged along the circumference of the main body and folded in a direction away from the central axis of the main body. The first skirt is sewn to the outer wall of the flange portion; The second skirt is connected to the inner wall of the main body by sewing.

5. The double-hole mitral valve replacement implant according to claim 4, characterized in that: The support pressure rod is connected to the main body by sewing, bonding, bolting, snapping, riveting, latching or hot-melting.

6. The double-orifice mitral valve replacement implant according to claim 1, characterized in that: The first skirt, the second skirt and the flow-blocking skirt are all woven; The weaving density of the flow-blocking skirt is respectively greater than the weaving density of the first skirt and the second skirt; The materials of the first skirt, the second skirt and the flow-blocking skirt independently include carbon fiber, polyethylene, polytetrafluoroethylene, silk, polypropylene or polyester.

7. The double-orifice mitral valve replacement implant according to claim 6, characterized in that: The thickness of the flow-blocking skirt is respectively greater than the thickness of the first skirt and the second skirt.

8. The double-orifice mitral valve replacement implant according to claim 1, characterized in that: The first biological valve and the second biological valve each independently include a valve skirt and at least three leaflets disposed in the valve skirt, and the leaflets are sutured and connected to the valve skirt; The valve skirt is sutured to the first inner stent or the second inner stent.

9. The double-orifice mitral valve replacement implant according to claim 1, characterized in that: The first inner bracket is connected to the second inner bracket by suture or rivet.

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