阅读说明：本技术 一种介入二尖瓣及包括其的介入二尖瓣置换系统 (Interventional mitral valve and interventional mitral valve replacement system comprising same ) 是由 杨军 李昊松 张丽 于 2021-09-18 设计创作，主要内容包括：本发明提供了一种介入二尖瓣及包括其的介入二尖瓣置换系统。所述介入二尖瓣包括支柱框架；所述支柱框架至少一侧的边缘设置有环形翻边结构；所述支柱框架的内部设置有至少三片生物组织瓣叶,所述瓣叶与支柱框架之间通过织物连接。本发明通过在所述支柱框架设置环形翻边结构,替代了在金属框架外周倾斜设置锚定件的传统方式,能够进一步地提高介入二尖瓣的牢固性。同时,所述介入二尖瓣可在瓣膜成形环修复效果较差需要进行TMVR时,经导管依次植入两个较小尺寸的介入二尖瓣,取代植入单个较大的介入二尖瓣,因其尺寸较小,支柱框架可做到比单个介入二尖瓣更坚固,且进入左心室部分也比单个介入二尖瓣少。(The invention provides an interventional mitral valve and an interventional mitral valve replacement system comprising the same. The interventional mitral valve includes a strut frame; the edge of at least one side of the strut frame is provided with an annular flanging structure; at least three biological tissue valve leaflets are arranged inside the strut frame, and the valve leaflets are connected with the strut frame through fabric. According to the invention, the annular flanging structure is arranged on the strut frame, so that the traditional mode that an anchor is obliquely arranged on the periphery of the metal frame is replaced, and the firmness of intervention in the mitral valve can be further improved. Meanwhile, when the annuloplasty ring has poor repair effect and TMVR needs to be performed, two interventional mitral valves with smaller sizes can be sequentially implanted through a catheter to replace a single larger interventional mitral valve.)

1. An interventional mitral valve, comprising a strut frame; the edge of at least one side of the strut frame is provided with an annular flanging structure; at least three biological tissue valve leaflets are arranged inside the strut frame, and the valve leaflets are connected with the strut frame through fabric.

2. The interventional mitral valve of claim 1, wherein the annular cuff structure is disposed at least on an outflow side of the valve after implantation in a body;

preferably, the annular flange structures are arranged on both sides of the pillar frame.

3. The interventional mitral valve of claim 1 or 2, wherein the annular cuff structure is a metal ring having an arc;

preferably, the metal ring is made of nickel-titanium alloy and/or cobalt-chromium alloy;

preferably, the radian of the flanging of the metal ring is 50-80 degrees;

preferably, the inner diameter of the metal ring is the same as that of the strut frame, and the outer diameter of the metal ring is 21-27 mm;

preferably, the annular flanging structure is a flange-shaped structure and is connected with the edge of the strut frame in an interference fit manner.

4. The interventional mitral valve of any of claims 1-3, wherein the interventional mitral valve has a manner of expansion that includes bulbing or self-expansion;

preferably, the interventional mitral valve is expanded in a ball-expanding manner, and the strut frame is made of memory metal, preferably nickel-titanium alloy;

preferably, the interventional mitral valve is self-expandable, and the strut frame is made of cobalt-chromium metal.

5. The interventional mitral valve of any one of claims 1-4, wherein the strut frame is a straight cylindrical metal frame having a continuous mesh structure;

preferably, the inner diameter of the strut frame is 18-24mm, and the height of the strut frame is 12-15 mm;

preferably, the grid structure is a diamond grid;

preferably, the area of the rhombic grid is 15-45mm²。

6. The interventional mitral valve of any of claims 1-5, wherein the fabric comprises dacron and/or PTFE;

preferably, the fabric is wrapped inside the stud frame;

preferably, the thickness of the fabric is 0.1-0.5 mm.

7. The interventional mitral valve of any one of claims 1-6, wherein edges of the leaflets abut one another in sequence to form a plane, and a center of the valve structure forms an orifice after coaptation;

preferably, the aperture of the small hole is 1.5mm or less.

8. An interventional mitral valve replacement system comprising a valve stent and at least two interventional mitral valves according to any one of claims 1-7.

9. The interventional mitral valve replacement system of claim 8, wherein the interventional mitral valve is disposed within a valve stent.

10. The interventional mitral valve replacement system of claim 8 or 9, wherein the strut frame at the end of the interventional mitral valve on the outflow side of the valve is provided with an annular flange structure that snaps back against the valve stent from the left ventricle side;

preferably, the interventional mitral valve is further provided with an annular cuff structure at the strut frame at the end on the inflow side of the valve, which reversely grips the valve holder from the left atrium side.

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to an interventional mitral valve and an interventional mitral valve replacement system comprising the same.

Background

Mitral regurgitation is the most common disease of the mitral valve, and the treatment for patients with mitral regurgitation usually has two ways, repair and replacement, with repair being the first choice and the best. Among them, one of the mitral valve repair methods is an annuloplasty ring that uses a large number of annuloplasty ring products, mainly classified into surgery and intervention. However, mitral valve replacement is still required when the repair is not adequate to achieve therapeutic results, and often the patient is unable to re-operate his or her own condition, and Transcatheter Mitral Valve Replacement (TMVR) is required.

CN209301400U discloses a prosthetic mitral valve intervention replacement device, which comprises a support and prosthetic valve leaflets, wherein the cross section of the lower edge of the support is D-shaped, the circumference of the support gradually decreases from top to bottom, and the lower edge of the support is connected with a plurality of prosthetic valve leaflets.

CN106963519A discloses a prosthetic mitral valve device implanted at the native mitral valve region of the heart. The prosthetic mitral valve coaptation enhancement device includes a body comprised of a stent frame and a valve element attached to the stent frame, wherein the body has a sealing section and a valve-bearing section; the shape of the sealing section of the main body has, in a compressed state, a form adapted to the coaptation area of the native mitral valve during systole, and in the sealing section of the main body the radial rigidity of the stent frame is lower than the radial rigidity of the valve carrying section; the prosthetic mitral valve coaptation enhancement device further includes at least one anchoring element coupled to the body and configured to anchor the body in a native mitral valve region of the heart.

The interventional mitral valve products currently used by TMVR are usually single-valve interventional treatments, mainly composed of memory alloy frames with biological tissue leaflets attached and fabrics partially coated on metal, and because the mitral valve is large in size, the corresponding interventional mitral valve products are also large in size. The metal frame adopted by the product is very light and thin, but the metal frame has larger size, so that the metal frame bears more stress, has insufficient durability and is easy to break or break down. In addition, the intervention mitral valve has a large size, so the intervention mitral valve has a large depth into the left ventricle part and is easy to be wound with chordae tendineae, thereby affecting the normal work and even causing the failure.

Accordingly, it is a significant research effort in the art to provide an interventional mitral valve and an interventional mitral valve replacement system including the same that adequately meets the needs of the human body by summing the opening areas of smaller valves.

Disclosure of Invention

In view of the deficiencies of the prior art, it is an object of the present invention to provide an interventional mitral valve and an interventional mitral valve replacement system comprising the same. The interventional mitral valve can be sequentially implanted with two interventional mitral valves of smaller sizes through a catheter instead of a single interventional mitral valve of larger size when TMVR is required due to poor annuloplasty ring repair effect, and the metal frame can be firmer than the single interventional mitral valve due to the smaller size, and the part entering the left ventricle is less than the single interventional mitral valve. The sum of the opening areas of the two smaller petals can meet the requirement of a human body, and a better treatment effect can be achieved.

In order to achieve the purpose, the invention adopts the following technical scheme:

in a first aspect, the present invention provides an interventional mitral valve comprising a strut frame; the edge of at least one side of the strut frame is provided with an annular flanging structure; at least three biological tissue valve leaflets are arranged inside the strut frame, and the valve leaflets are connected with the strut frame through fabric.

In the invention, the annular flanging structure is arranged on the edge of at least one side of the strut frame, so that the traditional mode of obliquely arranging an anchor at the periphery of a metal frame is replaced, the firmness of intervention in the mitral valve can be further improved, and the problem of valve falling and displacement caused by overhigh pressure on the outflow side of the closed mitral valve during heart contraction is prevented. And the interventional mitral valve can be sequentially implanted into two interventional mitral valves with smaller sizes through a catheter when TMVR is needed due to poor annuloplasty ring repair effect, so that a single larger interventional mitral valve is replaced, and due to the smaller size, the metal frame can be firmer than the single interventional mitral valve, the part entering the left ventricle is less than the single interventional mitral valve, the sum of the opening areas of the two smaller valves can be ensured to meet the requirement of a human body, and a better treatment effect can be achieved.

Preferably, the annular flanging structure is at least arranged at the outflow side of the valve after being implanted in the body.

In the invention, the valve outflow side refers to the side from which blood flows out of the valve, and the metal frame at the end is provided with an annular flanging structure which can be used for reversely buckling the valve bracket from the left ventricle side so as to prevent the valve from falling and shifting caused by the pressure on the closed mitral valve outflow side during the heart contraction.

Preferably, the annular flange structures are arranged on both sides of the pillar frame.

In the present invention, it is preferable to provide an annular flange structure on the valve inflow side, which is the side from which blood flows in the valve, and an annular flange structure on the metal frame at the end, which can be used to hold the valve holder from the left atrium side in a reverse direction, so as to prevent the valve from being displaced toward the left ventricle due to the pressure generated when blood flows in the side from the open mitral valve during diastole.

Preferably, the annular flanging structure is a metal ring with radian.

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

Preferably, the flanging radian of the metal ring is 50-80 degrees, and the flanging radian can be 50 degrees, 55 degrees, 60 degrees, 65 degrees, 70 degrees, 75 degrees, 80 degrees and the like.

Preferably, the inner diameter of the metal ring is the same as the inner diameter of the strut frame, and the outer diameter of the metal ring is 21-27mm, for example, 21mm, 22mm, 23mm, 24mm, 25mm, 26mm, 27mm, etc.

Preferably, the annular flanging structure is a flange-shaped structure and is connected with the edge of the strut frame in an interference fit manner.

Preferably, the interventional mitral valve has a dilation pattern that includes bulbing or self-dilation.

Preferably, the interventional mitral valve is expanded by a ball-expanding method, and the strut frame is made of memory metal, preferably nickel-titanium alloy.

The intervention mitral valve is expanded in a ball way, the dimension of the stent can be adjusted at will by adopting the memory alloy material, so that the stent is released after reaching the target position, is quickly expanded and props against the ventricular wall.

Preferably, the interventional mitral valve is self-expandable, and the strut frame is made of cobalt-chromium metal.

Preferably, the stud frame is a straight cylindrical metal frame having a continuous mesh structure.

Preferably, the inner diameter of the strut frame is 18-24mm, such as 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm, etc., and the height of the strut frame is 12-15mm, such as 12mm, 13mm, 14mm, 15mm, etc.

Preferably, the lattice structure is a diamond lattice.

Preferably, the area of the rhombic grid is 15-45mm²For example, it may be 15mm²、20mm²、25mm²、30mm²、35mm²、40mm²、45mm²And the like.

The grid shape of the metal framework is designed into a continuous rhombic net structure with proper size, so that the strength and the supporting force of the inner-layer bracket are improved, and the inner-layer bracket is prevented from being broken due to insufficient strength and supporting force.

Preferably, the fabric comprises dacron and/or PTFE.

Preferably, the fabric is wrapped inside the stud frame.

Preferably, the thickness of the fabric is 0.1-0.5mm, and may be, for example, 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, and the like.

Preferably, the edges of the valve leaflets are sequentially butted and folded to form a plane, and a small hole is formed in the center of the folded valve structure.

Preferably, the pores have a diameter of 1.5mm or less, for example, 1.5mm, 1.2mm, 1.0mm, 0.8mm, 0.5mm, 0.1mm, or the like.

In the present invention, the above leaflet structure is effective in preventing backflow.

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

Preferably, the interventional mitral valve is disposed within a valve stent.

It should be noted that any suitable size of valve stent may be inserted into the interventional mitral valve of the present invention for fitting, one of which is exemplified below.

Preferably, the valve support comprises a metal frame, and a support ring is arranged at one end edge of the metal frame along the circumferential outer edge; the metal frame is formed by enclosing a curved surface straight wall and a plane straight wall to form a D-shaped straight cylindrical structure; two ends of the metal frame are respectively provided with two connecting wires, and the two connecting wires respectively connect the curved straight wall edges and the plane straight wall edges at the two ends of the metal frame; and the two connecting wires at each end are respectively intersected in an X shape, and the interfaces at the two ends of the metal frame are cut into a shape like a Chinese character '8'.

Preferably, in the valve support, the support ring is composed of a plurality of U-shaped structures formed by metal wires extending from a metal frame.

Preferably, in the valve stent, the support ring further comprises a fabric layer wrapped between the U-shaped structures.

Preferably, in the valve support, at least one barb type anchor is obliquely arranged on the outer peripheral surface of the metal frame; the overhead hook type anchoring parts are arranged at the vertexes of the rhombic net structures, and only one overhead hook type anchoring part is arranged at the vertexes of the rhombic net structures which are connected with each other.

Preferably, the valve support has a compressed configuration and a deployed configuration, the valve support is implanted into the body by means of the delivery device in the compressed configuration, and the implantation target position is switched to the deployed configuration so as to be fixed at the valve; in the deployed configuration, the support ring is in the left atrium and the metal frame is in the left ventricle, securing the valve stent with an inverted hook anchor.

Preferably, the pillar frame of the intervention mitral valve at one end of the valve outflow side is provided with an annular flanging structure, and the annular flanging structure reversely buckles the valve support from the left ventricle side.

Preferably, the pillar frame of the intervention mitral valve at one end of the inflow side of the valve is provided with an annular flange structure which reversely buckles the valve support from the left atrium side.

Compared with the prior art, the invention has the beneficial effects that:

the invention provides an interventional mitral valve, which can be used for sequentially implanting two interventional mitral valves provided by the invention into an outer layer stent through a catheter when TMVR is required due to poor annuloplasty ring repair effect, so as to replace the implantation of a single larger interventional mitral valve.

Drawings

FIG. 1 is a schematic view of an interventional mitral valve with a cuff disposed on one side of a strut frame in accordance with the present invention;

wherein, 1-a strut frame; 2-annular flanging structure; 3-biological tissue valve leaflet.

FIG. 2 is a schematic view of the structure of an interventional mitral valve with flanges disposed on both sides of the strut frame;

wherein, 1-a strut frame; 2-annular flanging structure; 3-biological tissue valve leaflet.

FIG. 3 is an elevation view of an interventional mitral valve structure with a cuff disposed on one side of a strut frame in accordance with the present invention;

wherein, 1-a strut frame; 2-annular flanging structure; 3-biological tissue valve leaflet.

FIG. 4 is a top view of an interventional mitral valve structure with a cuff disposed on one side of the strut frame in accordance with the present invention;

wherein, 2-an annular flanging structure; 3-biological tissue valve leaflet.

FIG. 5 is a schematic structural view of a biological tissue leaflet according to the present invention;

wherein, the 3-biological tissue valve leaf.

FIG. 6 is a schematic structural diagram of an interventional valve stent provided by the present invention;

the device comprises a support ring, a metal frame, a reverse hook type anchor, a connecting wire and a U-shaped structure, wherein the support ring is 4-arranged, the metal frame is 5-arranged, the reverse hook type anchor is 6-arranged, and the connecting wire is 7-arranged.

Detailed Description

It is to 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", "inner", "outer", etc., indicate orientations or positional relationships based on those shown in the drawings, and are used only for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be taken as limiting the present invention. Furthermore, the terms "first", "second", etc. are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first," "second," etc. may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless otherwise specified.

It should be noted that, in the description of the present invention, unless otherwise explicitly specified or limited, the terms "disposed," "connected" and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art through specific situations.

The technical scheme of the invention is further explained by the specific implementation mode in combination with the attached drawings.

In one embodiment, the present invention provides an interventional mitral valve stent, as shown in fig. 1, comprising a strut frame 1; the edge of at least one side of the strut frame is provided with an annular flanging structure 2; at least three biological tissue valve leaflets 3 (shown in figure 5) are arranged inside the strut frame, and the valve leaflets 3 are connected with the strut frame 1 through fabric.

Further, the annular flanging structure 2 is at least arranged at the valve outflow side after being implanted in the body.

It should be noted that, as shown in fig. 1, the metal frame at one end of the outflow side of the valve (i.e. the side from which blood flows out of the valve) is provided with an annular flange structure 2, which can be used to hold the valve holder from the left ventricle side in a reverse direction, so as to prevent the valve from falling and shifting due to the pressure on the outflow side of the closed mitral valve during the contraction of the heart.

As a preferred technical solution of the present invention, the annular flange structures 2 are disposed on both sides of the pillar frame 1.

It should be noted that, as shown in fig. 2-4, the metal frame at the inflow side of the valve (i.e. the side from which blood flows in) may be optionally provided with an annular flange structure 2, which may be used to hold the valve holder from the left atrium side in a reversed manner, so as to prevent the valve from being displaced toward the left ventricle due to the pressure generated when blood flows in from the open mitral valve to the side during diastole.

It should be noted that, the present invention, by providing the annular flange structure 2 on the edge of at least one side of the pillar frame 1, replaces the traditional way of obliquely providing an anchor on the periphery of the metal frame, can further improve the robustness of intervention in the mitral valve, and prevent the valve from falling and shifting due to too high pressure on the outflow side of the closed mitral valve during heart contraction. And the interventional mitral valve can be sequentially implanted into two interventional mitral valves with smaller sizes through a catheter when TMVR is needed due to poor annuloplasty ring repair effect, so that a single larger interventional mitral valve is replaced, and due to the smaller size, the metal frame can be firmer than the single interventional mitral valve, the part entering the left ventricle is less than the single interventional mitral valve, the sum of the opening areas of the two smaller valves can be ensured to meet the requirement of a human body, and a better treatment effect can be achieved.

Further, the annular flanging structure 2 is a metal ring with a radian.

Further, the metal ring is made of nickel-titanium alloy and/or cobalt-chromium alloy.

Furthermore, the radian of the flanging of the metal ring is 50-80 degrees.

Further, the inner diameter of the metal ring is the same as that of the strut frame, and the outer diameter of the metal ring is 21-27 mm.

Further, the annular flanging structure 2 is a flange-shaped structure and is connected with the edge of the strut frame 1 in an interference fit manner.

Further, the interventional mitral valve has a dilation pattern that includes balloon dilation or self-dilation.

Furthermore, the interventional mitral valve is expanded in a ball-expanding manner, and the strut frame is made of memory metal, preferably nickel-titanium alloy.

Furthermore, the interventional mitral valve is self-expandable, and the strut frame is made of cobalt-chromium metal.

Further, the stud frame 1 is a straight cylindrical metal frame having a continuous mesh structure.

Further, the inner diameter of the strut frame 1 is 18-24mm, and the height of the strut frame 1 is 12-15 mm.

Further, the grid structure is a diamond grid;

further, the area of the rhombic grid is 15-45mm²。

Further, the fabric comprises dacron and/or PTFE.

Further, the fabric is wrapped inside the stud frame.

Further, the thickness of the fabric is 0.1-0.5 mm.

Furthermore, the edges of the valve leaflets are sequentially butted and folded to form a plane, and a small hole is formed in the center of the folded valve structure.

Further, the aperture of the small hole is 1.5mm or less.

In yet another embodiment, the present invention provides an interventional mitral valve replacement system comprising a valve stent and at least two interventional mitral valves as described in the first aspect.

Preferably, the interventional mitral valve is disposed within a valve stent.

It should be noted that any suitable size of valve stent may be inserted into the interventional mitral valve of the present invention for fitting, one of which is exemplified below.

In another embodiment, as shown in fig. 6, the valve stent comprises a metal frame 5, wherein a support ring 4 is arranged at one end edge of the metal frame 5 along the circumferential outer edge; the metal frame 5 is formed by enclosing a curved straight wall and a plane straight wall to form a D-shaped straight cylindrical structure; two ends of the metal frame 5 are respectively provided with two connecting wires 7, and the two connecting wires 7 respectively connect the curved straight wall edge and the planar straight wall edge at the two ends of the metal frame 5; and the two connecting wires 7 at each end are respectively intersected in an X shape, and the interfaces at the two ends of the metal frame 5 are cut into an 8 shape.

Further, in the valve stent, the support ring 4 is composed of a plurality of U-shaped structures 8 formed by metal wires extending from a metal frame.

Further, in the valve support, at least one barb type anchoring piece 6 is obliquely arranged on the outer peripheral surface of the metal frame 5; the overhead kick anchor 6 is arranged at the vertex of the rhombic net structure, and only one overhead kick anchor 6 is arranged at the vertex of the rhombic net structure connected with each other.

Furthermore, the pillar frame of the intervention mitral valve at one end of the outflow side of the valve is provided with an annular flanging structure, and the annular flanging structure reversely buckles the valve support from one side of the left ventricle.

Preferably, the pillar frame of the intervention mitral valve at one end of the inflow side of the valve is provided with an annular flange structure which reversely buckles the valve support from the left atrium side.

In another embodiment, the present invention provides a method of implanting an interventional mitral valve replacement system, comprising the steps of:

the intervention valve stent is brought into a patient body through the conveying device, when the intervention valve stent reaches a target position, the intervention valve stent is released, the intervention valve stent can be quickly unfolded from a contraction state and supports against a ventricle, and then two intervention mitral valves provided by the invention are sequentially implanted into the outer layer stent through the catheter.

The applicant declares that the above description is only a specific embodiment of the present invention, but the scope of the present invention is not limited thereto, and it should be understood by those skilled in the art that any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are within the scope and disclosure of the present invention.