A split valve stent and an interventional mitral valve replacement system including the same

Abstract

The present invention provides a split valve stent and an interventional mitral valve replacement system including the same. The split valve stent includes an outer frame and an inner frame arranged inside the outer frame to match; the outer frame includes a tubular outer metal frame with a kidney-shaped cross-section, one end of the outer metal frame is folded outward along the circumference to form a support ring, and at least one hook is provided at the kidney-shaped recess at the other end of the outer metal frame; the inner frame includes a tubular inner metal frame with a kidney-shaped cross-section, one end of the inner metal frame is provided with two connecting wires intersecting in an X shape, and the two connecting wires cut the interface of the end of the inner metal frame into an 8-shape; in the expanded state, the outer frame has a side with a support ring buckled on the valve ring on one side of the left atrium, and a side with a hook extends into the left ventricle; in the expanded state, the side of the inner frame without a connecting wire faces the left atrium, and the side with a connecting wire extends into the left ventricle.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a split valve stent and an interventional mitral valve replacement system comprising the same. Background Art

[0002] Mitral regurgitation is the most common mitral valve disease. There are usually two treatment options for patients with mitral regurgitation: repair and replacement. Repair is the first and best option, but when repair is not sufficient to achieve the desired therapeutic effect, mitral valve replacement is still needed. If the patient is unable to undergo surgery again due to their own condition, transcatheter mitral valve replacement (TMVR) is required.

[0003] At present, all transcatheter mitral valves are single-valve designs, mainly composed of biological tissue leaflets attached to a memory alloy frame and a portion of fabric coated on the metal. In addition, due to the large size of the mitral valve, the corresponding size of the interventional mitral valve product is also large, which makes it difficult to operate at the corners. Therefore, the metal frame used in the product needs to be very thin, but due to its large size, it is subjected to more stress, lacks durability, and is prone to breakage or failure. In addition, due to the large size of the interventional mitral valve, the part that penetrates deep into the left ventricle is also large, which is easy to entangle with the chordae tendineae, affecting normal operation and even causing failure.

[0004] CN212522085U discloses a mitral valve stent, comprising: an inner stent, internally connected to an artificial biological valve leaflet; an outer stent, connected and sleeved on the outside of the inner stent; a skirt, wrapped and connected to the inner stent; the upper end and / or lower end of the combination of the inner stent and the skirt is hollowed out; the mitral valve stent of the utility model can be used to ensure the smooth flow of blood at the pulmonary vein outlet of the left atrium when the upper end of the combination of the inner stent and the skirt is hollowed out. When the inner stent is moved downward so that the upper end of the inner stent does not exceed the valve ring, the part of the lower end of the combination of the inner stent and the skirt that protrudes from the outer stent will block the left ventricular outflow tract. The lower end of the combination of the inner stent and the skirt is designed to be hollowed out, which can be used to ensure the smooth flow of blood at the left ventricular outflow tract. At the same time, considering the guarantee of the smooth flow of blood at the left ventricular outflow tract and the smooth flow of blood at the pulmonary vein outlet of the left atrium, blood flow obstruction can be avoided, and it is more suitable for transcatheter mitral valve replacement.

[0005] CN113349987A discloses a mitral valve intervention valve and a delivery system, wherein the intervention valve includes a valve frame, a valve skirt and a valve leaflet, the valve skirt is fixedly covered on the inner wall of the valve frame, the valve leaflet is connected to the valve skirt, and the valve frame is in a stretched state, and one end of the valve frame is formed with an eversion structure. The intervention valve also includes an adjustment structure, one end of the adjustment structure is fixed to the valve frame or the valve skirt, and the other end of the adjustment structure is an operating end, which is used to adjust the implantation position of the mitral valve intervention valve by external force traction. It can further adjust the implantation state through the adjustment structure after implantation, so as to ensure that the implantation position of the intervention valve can effectively match the valve ring and prevent paravalvular leakage. In addition, the operating end of the adjustment structure can be fixed to the apex, so as to always have a restraining effect on the intervention valve, and cooperate with structures such as barbs to ensure the reliable cooperation between the intervention valve and the valve ring, and avoid the intervention valve from moving in the direction of the atrium and failing to cooperate with the valve ring to cause paravalvular leakage.

[0006] Based on the above research, it can be seen that the valve stent, as a commonly used device in TMVR, can provide positioning and support for TMVR and achieve the effect of treating MR. However, the valve stent has the risk of displacement, which cannot meet the subsequent TMVR technology. Therefore, it is of great practical significance to find a valve stent that provides a good positioning and fixation basis for interventional mitral valve implantation. Summary of the invention

[0007] In view of the shortcomings of the prior art, the purpose of the present invention is to provide a split valve stent and an interventional mitral valve replacement system including the same. The split valve stent is implanted in sequence from the femoral artery or the apex of the heart to the target position via a catheter. After being assembled and fixed, it provides a good positioning and fixing basis for interventional mitral valve implantation. In addition, the double-valve design makes the implanted interventional mitral valve smaller in size, and the sum of the effective opening areas can meet the needs of the human body and is easier to operate.

[0008] In order to achieve the purpose of the invention, the present invention adopts the following technical solutions:

[0009] In a first aspect, the present invention provides a split valve stent, the split valve stent comprising an outer frame and an inner frame arranged inside the outer frame to match the outer frame;

[0010] The outer frame comprises a tubular outer metal frame with a kidney-shaped cross section, one end of the outer metal frame is folded outwardly along the circumference to form a support ring, and at least one hook is provided at the kidney-shaped recess at the other end of the outer metal frame;

[0011] The inner frame comprises a tubular inner metal frame with a kidney-shaped cross section, one end of the inner metal frame is provided with two connecting wires intersecting in an X shape, and the two connecting wires cut the interface of the end of the inner metal frame into an 8-shape;

[0012] When the outer frame is in the expanded state, the side with the support ring is buckled on the valve ring on the left atrium side, and the side with the hook extends into the left ventricle. When the inner frame is in the expanded state, the side without the connecting wire faces the left atrium, and the side with the connecting wire extends into the left ventricle.

[0013] In the present invention, the split interventional bivalve mitral valve device is composed of an outer frame and an inner frame matched therewith from the outside to the inside. The outer frame is made of memory metal. After self-expansion, one folded end (i.e., one end of the outer metal frame is folded outward along the circumference to form a support ring) can be buckled on the valve ring on one side of the left atrium. The metal frame portion on the other side extends into the left ventricle. The cross-section of the valve ring opening viewed from the inflow side of the mitral valve is kidney-shaped (can be observed from a top view). The inner frame can also be called a connecting frame, which connects the outer frame and is used to support and fix the subsequently implanted interventional mitral valve. The cylindrical frame portion thereof is consistent in shape with the metal frame portion of the outer frame extending into the left ventricle. The outer side of the frame is provided with partial barbs facing the left atrium side to increase friction and prevent falling off. The two metal wires extending from one end of the outflow side intersect in an X shape, dividing the cross-section of the valve ring opening on the outflow side into an 8-shape, providing a good positioning and fixing basis for the subsequent implantation of the interventional mitral valve.

[0014] Preferably, the outer frame is made of memory metal, preferably nickel-titanium alloy.

[0015] The present invention uses memory alloy materials to arbitrarily adjust the sizes of the outer frame and the inner frame. During the implantation process of the frame, the frame is always in a contraction device and is released when it reaches the target position. At this time, the stent will quickly expand from the contracted state and press against the ventricular wall.

[0016] Preferably, the outer frame is a hollow mesh structure, preferably a honeycomb regular hexagonal hollow mesh structure.

[0017] Preferably, in the outer frame, the support ring formed by the outward folding is a planar structure or a saddle-shaped structure.

[0018] Preferably, in the outer frame, the angle between the support ring and the cylindrical outer metal frame after being everted is 90 to 160°, for example, it can be 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, etc.

[0019] Preferably, in the outer frame, the width of the support ring is 4-10 mm, for example, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, etc.

[0020] Preferably, the arc of the inner concave of the outer frame is 100-160°, for example, it can be 100°, 110°, 120°, 130°, 140°, 150°, 160°, etc.

[0021] Preferably, in the outer frame, the hook is arranged at the intersection of two regular hexagons at the other end of the outer metal frame, is concave along one side of the kidney-shaped depression, and is bent toward one side of the support ring.

[0022] Preferably, the outer frame is provided with at least one developing point, preferably 2-10, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, etc.

[0023] Preferably, in the outer frame, the developing point is arranged on a side of the outer frame extending into the left ventricle.

[0024] Preferably, there are four developing points arranged in the outer frame, two of which are arranged on the concave side and two on the convex side of the cylindrical outer metal frame with a kidney-shaped cross-section.

[0025] Preferably, the material of the outer frame developing points includes platinum-iridium alloy and / or tantalum metal.

[0026] Preferably, in the inner frame, the portion where the two connecting wires intersect in an X shape is a welding section, and the length of the welding section is 1-3 mm, for example, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, etc.

[0027] Preferably, the connecting wire is made of memory metal, preferably nickel-titanium alloy.

[0028] Preferably, the inner metal frame is a hollow mesh structure, preferably a diamond-shaped hollow mesh structure.

[0029] Preferably, at least one inverted hook anchor is obliquely provided on the outer peripheral surface of the inner metal frame.

[0030] Preferably, in the inner frame, the inverted hook type anchor is arranged on the vertices of the diamond-shaped mesh structure, and only one inverted hook type anchor is arranged on the vertices of the interconnected diamond-shaped mesh structures.

[0031] Preferably, in the inner frame, the inverted hook type anchor is spike-shaped and is arranged obliquely upward toward the left atrium.

[0032] Preferably, the inclination angle of the inverted hook anchor is 70-90°, for example, it can be 70°, 75°, 80°, 85°, 90°, etc.

[0033] Preferably, the length of the barbed hook anchor is 5-8 mm, for example, 5 mm, 5.5 mm, 6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm, etc.

[0034] Preferably, the inner frame is provided with at least one developing point corresponding to the position of the outer metal frame, preferably 2-10, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, etc.

[0035] Preferably, the developing point is arranged on a side of the inner frame extending into the left ventricle.

[0036] Preferably, there are four developing points arranged in the inner frame, two of which are arranged on the concave side and two on the convex side of the cylindrical inner metal frame with a kidney-shaped cross-section.

[0037] Preferably, the material of the inner frame developing point includes platinum-iridium alloy and / or tantalum metal.

[0038] In a second aspect, the present invention provides an interventional mitral valve replacement system, comprising the split valve stent as described in the first aspect and at least two interventional mitral valves.

[0039] Preferably, the interventional mitral valve includes a support frame, and an annular flange structure is provided on the edge of one side of the support frame. The annular flange structure is arranged on the outflow side of the valve after implantation in the body, and reversely buckles the split valve stent from the left ventricle side; and at least three biological tissue leaflets are arranged inside the support frame, and the leaflets are connected to the support frame by fabric.

[0040] In the present invention, an annular flange structure is provided on the edge of at least one side of the support frame, replacing the traditional method of obliquely providing anchors on the outer periphery of the metal frame, which can further improve the firmness of the interventional mitral valve and prevent the problem of valve dislocation caused by excessive pressure on the outflow side of the closed mitral valve during heart contraction. Moreover, when the repair effect of the annuloplasty ring is poor and TMVR is required, the interventional mitral valve can be implanted in sequence through a catheter to replace the implantation of a single larger interventional mitral valve. Due to its smaller size, the metal frame can be made stronger than a single interventional mitral valve, and the part entering the left ventricle is also less than that of a single interventional mitral valve, and it can still ensure that the sum of the opening areas of the two smaller valves is sufficient to meet the needs of the human body, and can achieve better treatment effects.

[0041] In the present invention, the valve outflow side refers to the side where blood flows out of the valve. The metal frame at this end is provided with an annular flange structure, which can reversely buckle the valve support from the left ventricle side to prevent the pressure on the outflow side of the closed mitral valve during heart contraction from causing the valve to fall off and shift.

[0042] Preferably, in the interventional mitral valve, the annular flange structure is a metal ring with a curvature.

[0043] Preferably, the metal ring is made of nickel-titanium alloy and / or cobalt-chromium alloy.

[0044] Preferably, the flange arc of the metal ring is 50-80°, for example, it can be 50°, 55°, 60°, 65°, 70°, 75°, 80°, etc.

[0045] Preferably, the inner diameter of the metal ring is the same as the inner diameter of the support frame, and the outer diameter of the metal ring is 21-27 mm, for example, it can be 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, etc.

[0046] Preferably, in the interventional mitral valve, the annular flange structure is a flange-like structure and is connected to the edge of the support frame by interference fit.

[0047] Preferably, the interventional mitral valve has an expansion mode including balloon expansion or self-expansion.

[0048] Preferably, the interventional mitral valve expansion method is balloon expansion, and the support frame is made of cobalt-chromium metal. The size of the stent can be adjusted arbitrarily so that it can be released after reaching the target position, expand rapidly, and press against the ventricular wall.

[0049] Preferably, the expansion mode of the interventional mitral valve is self-expansion, and the material of the support frame is a memory alloy material, preferably a nickel-titanium alloy. The size of the stent can be adjusted arbitrarily so that it can be released after reaching the target position, expand rapidly, and press against the ventricular wall.

[0050] Preferably, in the interventional mitral valve, the support frame is a straight cylindrical metal frame with a continuous grid structure.

[0051] Preferably, in the interventional mitral valve, the inner diameter of the support frame is 18-24 mm, for example, it can be 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, etc., and the height of the support frame is 12-15 mm, for example, it can be 12 mm, 13 mm, 14 mm, 15 mm, etc.

[0052] Preferably, in the interventional mitral valve, the grid structure is a diamond-shaped grid.

[0053] Preferably, in the interventional mitral valve, the area of ​​the diamond grid is 15-45 mm 2 , for example, it can be 15mm 2 , 20mm 2 , 25mm 2 , 30mm 2 , 35mm 2 , 40mm 2 , 45mm 2wait.

[0054] The present invention designs the mesh shape of the metal frame of the interventional mitral valve to be a continuous diamond mesh structure of appropriate size to improve the strength and support force of the inner layer stent and avoid the inner layer stent from breaking due to insufficient strength and support force.

[0055] Preferably, in the interventional mitral valve, the fabric comprises polyester and / or PTFE.

[0056] Preferably, in the interventional mitral valve, the fabric is wrapped around the inner side of the strut frame.

[0057] Preferably, in the interventional mitral valve, the thickness of the fabric is 0.1-0.5 mm, for example, it can be 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, etc.

[0058] Preferably, in the interventional mitral valve, the edges of the leaflets are sequentially abutted and closed to form a plane, and a small hole is formed in the center of the closed valve structure.

[0059] Preferably, in the interventional mitral valve, the diameter of the small hole is less than 1.5 mm, for example, it can be 1.5 mm, 1.2 mm, 1.0 mm, 0.8 mm, 0.5 mm, 0.1 mm, etc.

[0060] In the present invention, intervention of the leaflet structure of the mitral valve can effectively prevent regurgitation.

[0061] Compared with the prior art, the present invention has the following beneficial effects:

[0062] The present invention provides a split interventional double-valve mitral valve device, which implants components sequentially through a catheter from the femoral artery or the apex of the heart to the target position. After being assembled and fixed, it provides a good positioning and fixation basis for interventional mitral valve implantation. In addition, the double-valve design makes the valve angle height of the implanted mitral valve lower, and the sum of the effective opening areas can meet the needs of the human body and is easier to operate. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] Figure 1 The split valve stent provided by the present invention includes a structural schematic diagram of an outer frame;

[0064] Figure 2 The split valve stent provided by the present invention includes a top view of the outer frame;

[0065] Figure 3 The split valve stent provided by the present invention includes a side view of the outer frame;

[0066] Among them, 11 is an outer metal frame, 12 is a support ring, 13 is a hook, and 14 is an outer frame developing point.

[0067] Figure 4 The split valve stent provided by the present invention includes a structural schematic diagram of an inner frame;

[0068] Figure 5 The split valve stent provided by the present invention includes a top view of the inner frame;

[0069] Figure 6 The split valve stent provided by the present invention includes a side view of the inner frame;

[0070] Among them, 21 is the inner metal frame, 22 is the connecting wire, 23 is the inverted hook anchor, and 24 is the inner frame developing point.

[0071] Figure 7 A schematic diagram of the structure of the interventional mitral valve replacement system provided by the present invention;

[0072] Among them, 1 is the outer frame, 2 is the inner frame, and 3 is the interventional mitral valve.

[0073] Figure 8 A schematic diagram of the structure of the interventional mitral valve provided by the present invention;

[0074] Among them, 31 is a support frame, 32 is an annular flange structure, and 33 is a biological tissue leaflet. DETAILED DESCRIPTION

[0075] 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.

[0076] 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.

[0077] The technical solution of the present invention is further described below with reference to the accompanying drawings and through specific implementation methods.

[0078] In a specific embodiment, the present invention provides a split valve stent, the split valve stent comprises an outer frame 1 (such as Figure 1 , Figure 2 , Figure 3 ) and an inner frame 2 (as shown) arranged inside the outer frame to match Figure 4 , Figure 5 , Figure 6 shown).

[0079] like Figure 1-Figure 3 As shown, the outer frame 1 includes a tubular outer metal frame 11 with a kidney-shaped cross-section, one end of the outer metal frame 11 is folded outward along the circumference to form a support ring 12, and at least one hook 13 is provided in the kidney-shaped recess at the other end of the outer metal frame 11.

[0080] like Figure 4-Figure 6 As shown, the inner frame 2 includes a tubular inner metal frame 21 with a kidney-shaped cross-section, and one end of the inner metal frame 21 is provided with two connecting wires 22 intersecting in an X shape, and the two connecting wires 22 cut the interface of the end of the inner metal frame into an 8 shape.

[0081] When the outer frame 1 is in the expanded state, the side with the support ring 12 is buckled on the valve ring on the left atrium side, and the side with the hook 13 extends into the left ventricle. When the inner frame 2 is in the expanded state, the side without the connecting wire faces the left atrium, and the side with the connecting wire 22 extends into the left ventricle.

[0082] It should be noted that if Figure 1 As shown, the split-type interventional bicuspid valve device of the present invention is composed of an outer frame 1 and an inner frame 2 matched therewith from the outside to the inside; wherein, after the outer frame 1 is expanded, one folded end (i.e., one end of the outer metal frame is folded outwardly along the circumference to form a support ring) can be buckled on the valve ring on one side of the left atrium, and the metal frame part on the other side extends into the left ventricle, and the cross-section of the valve ring opening viewed from the inflow side of the mitral valve (i.e., the side from which the blood flow flows into the valve) is kidney-shaped (such as Figure 2The top view provided can directly observe the kidney-shaped cross section in the center). In particular, the concave design of the kidney shape can well reduce the tilting effect of the stent toward the outflow tract. The design of the hook 13 can well hook the leaflet on one side of the outflow tract and be concave with the stent.

[0083] It should be noted that if Figure 4 As shown, the inner frame 2 can also be called a connecting frame, which is connected to the outer frame 1 and is used to support and fix the subsequently implanted interventional mitral valve 3. Its cylindrical frame portion (inner metal frame 21) is consistent in shape with the metal frame portion of the outer frame extending into the left ventricle (can be matched and embedded in the outer frame). The two metal wires extending from one end of the valve outflow side of the inner frame 1 (i.e., the side where blood flows out of the valve) intersect in an X shape, dividing the cross-section of the outflow side valve ring into an 8 shape, providing a good positioning and fixation basis for the subsequent implantation of the interventional mitral valve 3.

[0084] Furthermore, the outer frame 1 is made of memory metal, preferably nickel-titanium alloy.

[0085] It should be noted that the present invention, by adopting memory alloy material, can arbitrarily adjust the size of the outer frame and the inner frame. During the implantation process of the frame, it is always in a contraction device and is released when it reaches the target position. At this time, the stent will quickly expand from the contracted state and press against the ventricular wall.

[0086] Furthermore, the outer frame 1 is a hollow mesh structure, preferably a honeycomb regular hexagonal hollow mesh structure.

[0087] Furthermore, the support ring 12 formed by the outward folding is a planar structure or a saddle-shaped structure.

[0088] Furthermore, the included angle between the support ring 12 and the cylindrical outer metal frame after being everted is 90 to 160 degrees.

[0089] Furthermore, the width of the support ring 12 is 4-10 mm.

[0090] Furthermore, the concave arc of the outer frame 1 is 100-160°.

[0091] Furthermore, the hook 13 is disposed at the intersection of two regular hexagons at the other end of the outer metal frame 11 , is concave along one side of the kidney-shaped depression, and is bent toward one side of the support ring 12 .

[0092] As a preferred technical solution of the present invention, the outer frame is provided with at least one developing point 14, preferably 2-10.

[0093] Furthermore, the developing point 14 is arranged on a side of the outer frame 1 extending into the left ventricle.

[0094] Furthermore, if Figure 1-Figure 3 As shown, there are four developing points 14 arranged in the outer frame 1, two of which are arranged on the concave side and two on the convex side of the tubular outer metal frame 11 with a kidney-shaped cross-section.

[0095] It should be noted that if Figure 1-Figure 3 As shown, the position of the developing point 14 is based on the orientation or positional relationship shown in the accompanying drawings. It is only for the convenience of describing the present invention and simplifying the description. Four developing points are set. As long as two are provided at the front and back, it is sufficient to facilitate the positioning direction of the barbed D-type anchor bracket. It does not indicate or imply that the device or element referred to must have a specific orientation.

[0096] Furthermore, the material of the outer frame developing point 14 includes platinum-iridium alloy and / or tantalum metal.

[0097] Furthermore, in the inner frame 2, the portion where the two connecting wires 22 intersect in an X shape is a welding section, and the length of the welding section is 1-3 mm.

[0098] Furthermore, the connecting wire 22 is made of memory metal, preferably nickel-titanium alloy.

[0099] Furthermore, the inner metal frame 21 is a hollow mesh structure, preferably a diamond-shaped hollow mesh structure.

[0100] Furthermore, at least one inverted hook anchor 23 is obliquely provided on the outer peripheral surface of the inner metal frame 21 .

[0101] Furthermore, the inverted hook type anchor 23 is arranged at the vertices of the diamond mesh structure, and only one inverted hook type anchor 23 is arranged at the vertices of the interconnected diamond mesh structures.

[0102] Furthermore, the inverted hook type anchor 23 is spike-shaped and is disposed obliquely upward toward the left atrium.

[0103] Furthermore, the inclination angle of the inverted hook type anchor 23 is 70-90°.

[0104] Furthermore, the length of the inverted hook anchor 23 is 5-8 mm.

[0105] Furthermore, the inner frame 2 is provided with at least one developing point 24 corresponding to the position of the outer metal frame, preferably 2-10 developing points.

[0106] Furthermore, the developing point 24 is arranged on a side of the inner frame 2 extending into the left ventricle.

[0107] Furthermore, if Figure 4-Figure 6As shown, there are four developing points 24 arranged in the inner frame 2, two of which are arranged on the concave side and two on the convex side of the tubular inner metal frame 21 with a kidney-shaped cross-section.

[0108] It should be noted that if Figure 4-Figure 6 As shown, the position of the inner frame developing point 24 is based on the orientation or positional relationship shown in the accompanying drawings. It is only for the convenience of describing the present invention and simplifying the description. Four developing points are set as long as two are provided at the front and back and the corresponding positioning with the outer frame developing points is met. It does not indicate or imply that the device or element referred to must have a specific orientation.

[0109] Furthermore, the material of the inner frame developing point 24 includes platinum-iridium alloy and / or tantalum metal.

[0110] In another specific embodiment, the present invention provides an interventional mitral valve replacement system, the structure of the interventional mitral valve replacement system is as follows: Figure 7 As shown, the interventional mitral valve replacement system includes the split valve stent and at least two interventional mitral valves 3, wherein the split valve stent includes an outer frame 1 and an inner frame 2 arranged inside the outer frame to match it.

[0111] Furthermore, the structure of the interventional mitral valve 3 is as follows Figure 8 As shown, the interventional mitral valve 3 includes a support frame 31, and an annular flange structure 32 is provided at the edge of one side of the support frame 31. The annular flange structure 32 is arranged on the outflow side of the valve after implantation in the body, and reversely buckles the split valve stent from the left ventricle side; and at least three biological tissue leaflets 33 are arranged inside the support frame 31, and the leaflets 33 are connected to the support frame 31 by fabric.

[0112] It should be noted that if Figure 8 As shown, the metal frame at one end of the valve inflow side (i.e., the side where blood flows in from the valve) can be optionally provided with an annular flange structure 32, which can reversely buckle the valve support from the left atrium side to prevent the valve from shifting to the left ventricle due to the pressure generated when blood flows in from the inflow side of the opened mitral valve during diastole. Moreover, when the annuloplasty ring repair effect is poor and TMVR is required, the interventional mitral valve can be implanted in sequence with two smaller interventional mitral valves via catheter to replace the implantation of a single larger interventional mitral valve. Due to its smaller size, the metal frame can be made stronger than a single interventional mitral valve, and the part entering the left ventricle is also less than that of a single interventional mitral valve, and it can still ensure that the sum of the opening areas of the two smaller valves is sufficient to meet the needs of the human body, thereby achieving a better treatment effect.

[0113] Furthermore, in the interventional mitral valve 3, the annular flange structure 32 is a metal ring with a curvature.

[0114] Furthermore, in the interventional mitral valve 3, the material of the metal ring is nickel-titanium alloy and / or cobalt-chromium alloy.

[0115] Furthermore, in the interventional mitral valve 3, the arc of the flange of the metal ring is 50-80°.

[0116] Furthermore, in the interventional mitral valve 3, the inner diameter of the metal ring is the same as the inner diameter of the support frame, and the outer diameter of the metal ring is 21-27 mm.

[0117] Furthermore, in the interventional mitral valve 3, the annular flange structure is a flange-like structure and is connected to the edge of the support frame by interference fit.

[0118] Furthermore, in the interventional mitral valve 3, the expansion mode of the interventional mitral valve includes balloon expansion or self-expansion.

[0119] Furthermore, in the interventional mitral valve 3, the expansion method of the interventional mitral valve is balloon expansion, and the material of the support frame is cobalt-chromium metal. The size of the stent can be adjusted arbitrarily so that it can be released after reaching the target position, and quickly expand to press against the ventricular wall.

[0120] Furthermore, in the interventional mitral valve 3, the expansion mode of the interventional mitral valve is self-expansion, and the material of the support frame is a memory alloy material, preferably a nickel-titanium alloy. The size of the stent can be adjusted arbitrarily so that it can be released after reaching the target position, and quickly expand to press against the ventricular wall.

[0121] Furthermore, in the interventional mitral valve 3, the support frame 31 is a straight cylindrical metal frame with a continuous grid structure.

[0122] Furthermore, in the interventional mitral valve 3, the inner diameter of the support frame 31 is 18-24 mm, and the height of the support frame is 12-15 mm.

[0123] Furthermore, in the interventional mitral valve 3, the grid structure is a diamond grid.

[0124] Furthermore, in the interventional mitral valve 3, the area of ​​the diamond grid is 15-45 mm 2 .

[0125] The present invention designs the mesh shape of the metal frame of the interventional mitral valve to be a continuous diamond mesh structure of appropriate size to improve the strength and support force of the inner layer stent and avoid the inner layer stent from breaking due to insufficient strength and support force.

[0126] Further, in the interventional mitral valve 3, the fabric includes polyester and / or PTFE.

[0127] Furthermore, in the interventional mitral valve 3, the fabric is wrapped around the inner side of the support frame.

[0128] Furthermore, in the interventional mitral valve 3, the thickness of the fabric is 0.1-0.5 mm.

[0129] Furthermore, in the interventional mitral valve 3, the edges of the leaflets are sequentially abutted and closed to form a plane, and a small hole is formed in the center of the closed valve structure.

[0130] Furthermore, in the interventional mitral valve 3, the aperture of the small hole is less than 1.5 mm.

[0131] In the present invention, intervention of the leaflet structure of the mitral valve can effectively prevent regurgitation.

[0132] In another specific embodiment, the present invention provides a method for implanting an interventional mitral valve replacement system, comprising the following steps:

[0133] (1) Implant the external frame into the target location via a catheter from the femoral artery or apical approach;

[0134] (2) The inner frame is implanted by assisting positioning with four developing points provided on the outer frame and the inner frame;

[0135] (3) After combined fixation, the interventional mitral valve is finally implanted.

[0136] It should be noted that the purpose of the present invention is to provide a split interventional double-valve mitral valve device, in which the components are implanted sequentially from the femoral artery or the apex of the heart to the target position via a catheter. After being assembled and fixed, a good positioning and fixation basis is provided for the interventional mitral valve implantation. In addition, the double-valve design makes the implanted interventional mitral valve smaller in size, and the sum of the effective opening areas can not only meet the needs of the human body, but also is easier to operate.

[0137] 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 split valve stent, characterized in that: The split valve stent comprises an outer frame and an inner frame arranged inside the outer frame and matching with the inner frame; The outer frame comprises a cylindrical outer metal frame with a kidney-shaped cross-section, one end of the outer metal frame is folded outward along the circumference to form a support ring, and at least one hook is provided at the kidney-shaped depression at the other end of the outer metal frame. The outer frame is a honeycomb regular hexagonal hollow mesh structure, and the hook is provided at the intersection of two regular hexagons at the other end of the outer metal frame, and is concave along one side of the kidney-shaped depression and bent toward one side of the support ring; The inner frame comprises a tubular inner metal frame with a kidney-shaped cross section, one end of the inner metal frame is provided with two connecting wires intersecting in an X shape, and the two connecting wires cut the interface of the end of the inner metal frame into an 8-shape; When the outer frame is in the expanded state, the side with the support ring is buckled on the valve ring on the left atrium side, and the side with the hook extends into the left ventricle. When the inner frame is in the expanded state, the side without the connecting wire faces the left atrium, and the side with the connecting wire extends into the left ventricle.

2. The split valve stent according to claim 1, characterized in that: The material of the outer frame is memory metal.

3. The split valve stent according to claim 2, characterized in that: The material of the outer frame is nickel-titanium alloy.

4. The split valve stent according to claim 1, characterized in that: The support ring formed by the outward folding is a plane structure or a saddle-shaped structure.

5. The split valve stent according to claim 1, characterized in that: The angle between the support ring and the cylindrical outer metal frame after being everted is 90 to 160 degrees.

6. The split valve stent according to claim 1, characterized in that: The width of the support ring is 4-10 mm.

7. The split valve stent according to claim 1, characterized in that: The concave arc of the outer frame is 100-160 degrees.

8. The split valve stent according to claim 1, characterized in that: The outer frame is provided with at least one developing point.

9. The split valve stent according to claim 8, characterized in that: The number of the developing points is 2-10.

10. The split valve stent according to claim 8, characterized in that: The developing point is arranged on a side of the outer frame extending into the left ventricle.

11. The split valve stent according to claim 8, characterized in that: There are four developing points arranged in the outer frame, two of which are arranged on the inner concave side and two on the outer convex side of the tubular outer metal frame with a kidney-shaped cross-section.

12. The split valve stent according to claim 8, characterized in that: The material of the outer frame developing point includes platinum-iridium alloy and / or tantalum metal.

13. The split valve stent according to claim 1, characterized in that: The portion where the two connecting wires intersect in an X shape is a welding section, and the length of the welding section is 1-3 mm.

14. The split valve stent according to claim 1, characterized in that: The material of the connecting wire is memory metal.

15. The split valve stent according to claim 14, characterized in that: The material of the connecting wire is nickel-titanium alloy.

16. The split valve stent according to claim 1, characterized in that: The material of the inner frame is memory metal.

17. The split valve stent according to claim 1, characterized in that: The material of the inner frame is nickel-titanium alloy.

18. The split valve stent according to claim 1, characterized in that: The inner frame is a hollow mesh structure.

19. The split valve stent according to claim 18, characterized in that: The inner frame is a diamond-shaped hollow mesh structure.

20. The split valve stent according to claim 1, characterized in that: At least one inverted hook type anchor is obliquely arranged on the outer peripheral surface of the inner metal frame.

21. The split valve stent according to claim 20, characterized in that: The inverted hook type anchor is arranged on the vertices of the diamond-shaped mesh structure, and only one inverted hook type anchor is arranged on the vertices of the interconnected diamond-shaped mesh structures.

22. The split valve stent according to claim 20, characterized in that: The inverted hook type anchor is spike-shaped and is arranged obliquely upward toward the left atrium.

23. The split valve stent according to claim 20, characterized in that: The inclination angle of the inverted hook type anchor is 70-90°.

24. The split valve stent according to claim 20, characterized in that: The length of the barbed hook anchor is 5-8 mm.

25. The split valve stent according to claim 1, characterized in that: The inner frame is provided with at least one developing point corresponding to the position of the outer metal frame.

26. The split valve stent according to claim 25, characterized in that: The number of the developing points is 2-10.

27. The split valve stent according to claim 25, characterized in that: The developing point is arranged on a side of the inner frame extending into the left ventricle.

28. The split valve stent according to claim 25, characterized in that: There are four developing points arranged in the inner frame, two of which are arranged on the inner concave side and two on the outer convex side of the tubular inner metal frame with a kidney-shaped cross-section.

29. The split valve stent according to claim 25, characterized in that: The material of the inner frame developing point includes platinum-iridium alloy and / or tantalum metal.

30. An interventional mitral valve replacement system, characterized in that: The interventional mitral valve replacement system comprises a split valve stent as described in any one of claims 1 to 29 and at least two interventional mitral valves.

31. The interventional mitral valve replacement system according to claim 30, characterized in that: The interventional mitral valve includes a support frame, and an annular flange structure is provided on the edge of one side of the support frame. The annular flange structure is arranged on the outflow side of the valve after implantation in the body, and reversely buckles the split valve support from the left ventricle side; and at least three biological tissue leaflets are arranged inside the support frame, and the leaflets are connected to the support frame by fabric.

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