WO2020073981A1

WO2020073981A1 - Valve stent and prosthetic heart valve

Info

Publication number: WO2020073981A1
Application number: PCT/CN2019/110538
Authority: WO
Inventors: 阳明; 冒鹏志; 陈国明; 赵婧; 李�雨
Original assignee: 上海微创心通医疗科技有限公司
Priority date: 2018-10-11
Filing date: 2019-10-11
Publication date: 2020-04-16
Also published as: CN111035472A

Abstract

A valve stent (10) and a prosthetic heart valve. The valve stent comprises a stent body (102) provided in a grid shape, at least one catch lug (103) and a flange (101) which are connected to the stent body (102). The outer diameter D of the flange (101) is greater than the diameter d at the junction between the flange (101) and the stent body (102), so that the lower horizontal surface of the flange (101) tightly fits the heart's native valve annulus and leaflet (201), and the edge-upturned end surface thereof tightly fits the inner wall of the left atrium to achieve upper limiting and sealing functions, preventing the valve stent (10) from sliding out toward the left ventricular end. When the valve stent (10) is compressed into a sheath, the catch lug (103) is embedded into the grid of the stent body (102) connected to the catch lug (103), so as to reduce the stent thickness of the valve stent (10) after being compressed and diameter-reduced, thereby facilitating the intervention of the valve stent (10) to the human body through the femoral vein path, reducing the diameter of a transporter catheter, and reducing the difficulty of transporting and damage to blood vessels. In addition, the catch lug (103) hooks the chordae tendineae (202) while catching the native leaflet (201) to form a lower limit, preventing the valve stent (10) from escaping toward the left atrium end due to external forces such as blood flow flushing and heart compression.

Description

Valve support and prosthetic heart valve

Technical field

[0001] The present invention relates to the technical field of medical devices, in particular to a valve stent and a prosthetic heart valve.

Background technique

[0002] With the development of social economy and the aging of the population, senile valvular disease and valvular disease caused by coronary heart disease and myocardial infarction are more and more common. Studies have shown that more than 13.3% of elderly people over the age of 75 suffer from varying degrees of valvular heart disease. Heart valve disease has gradually become one of the important reasons threatening human health.

[0003] Mitral valve disease is a relatively common clinical heart valve disease. The human heart is divided into four chambers: the left atrium, the left ventricle and the right atrium, and the right ventricle. The two atria are connected to the two ventricles, and the two ventricles are connected to the two large arteries. The mitral valve grows between the left atrium and the left ventricle, and consists of valve leaflets, annulus, chordae, and papillary muscles. It acts as a one-way valve to ensure one-way movement of blood flow.

[0004] In 1984, Inoue et al. Reported for the first time that percutaneous mitral valve balloon angioplasty for the treatment of mitral stenosis. Today, this method has become increasingly sophisticated and has become an important measure for interventional treatment of mitral stenosis. Moreover, with the recent success of percutaneous prosthetic pulmonary valve and aortic valve stent implantation in clinical trials, as well as the success of foreign scholars using two different valved stents for percutaneous tricuspid valve implantation in animal experiments, it indicates that Interventional techniques will have a greater role in the treatment of atrioventricular valve diseases.

Summary of the invention

technical problem

[0005] However, despite the rapid development of mitral valve replacement technology, there are still some recognized problems in the design of valve stents. Compared with the aortic valve, the heart's native mitral valve annulus has a larger diameter. In order to consider the performance of anti-valvular leakage and stent anchoring performance, the size of the artificial mitral valve stent will also be larger, which will bring about A series of questions:

[0006] 1. The larger the size of the artificial valve stent, the more difficult it is to hold the stent. The diameter of the catheter required to deliver the valve stent will also be large, increasing the difficulty of delivery and damage to the blood vessel.

[0007] 2. The larger the size of the artificial valve support, the larger the area of the artificial valve leaflet, and the larger the area of the valve leaflet, the artificial valve The lower the fatigue resistance of the membrane support.

[0008] 3. The area of the artificial valve leaflet is proportional to the height required for the opening and closing movement of the valve leaflet, that is, the larger the area of the artificial valve leaflet

, The higher the height of the valve stent. If the height of the artificial valve stent under the valve is too high, it will affect the original heart structure and heart function, rupture of tendon cord, abnormal heart tissue such as touching the papillary muscle, and it is easy to cause obstruction of the left ventricular outflow and induce adverse postoperative effects. In order to reduce the height of the prosthetic valve stent, most of the artificial valve stents at home and abroad mostly use internal and external double-layer stents to reduce the diameter of the valve stent, thereby reducing the height of the valve stent, but the double-layer stent greatly increases the pressure of the stent. Difficulty.

Solution to the problem

Technical solution

[0009] In view of the above-mentioned shortcomings of the prior art, the object of the present invention is to provide a valve stent and a prosthetic heart valve, in order to solve the existing artificial valve stent due to the high height of the left ventricle outflow tract obstruction and other adverse surgery After effects, due to the large leaflet area, the stent has poor fatigue resistance, and the difficulty of delivery due to the large size of the stent and the damage to the blood vessel and left ventricle.

[0010] According to an aspect of the present invention, there is provided a valve stent, comprising a stent body arranged in a grid, at least one grab ear connected to the stent body and a flange, the outer diameter D of the flange It is larger than the diameter d where the flange is connected to the bracket body, and the size of the gripping ear is smaller than the grid size of the bracket body connected to the gripping ear.

[0011] Further, in the above valve stent, the diameter range of the upper end or the lower end of the stent body is 20 mm 50 mm.

[0012] Further, in the above valve stent, the outer diameter of the flange is in the range of 30mm ^ EK80mm.

[0013] Further, in the above valve stent, the range of the diameter of the connection between the flange and the stent body is

20mm <d <50mm

[0014] Further, in the above valve stent, one end of the grasping ear is fixed on the stent body, and the other end is radially outwardly warped.

[0015] Further, in the above valve stent, the grasping ear is a straight rod or a curved wave rod.

[0016] Further, in the above-mentioned valve stent, a texture structure is provided on the grasping ear.

[0017] Further, in the above-mentioned valve stent, the grasping ear is connected to the mesh node of the stent body, or to the mesh edge bar of the stent body. [0018] Further, in the above valve stent, the grasping ear is located on the lower end grid of the stent body.

[0019] Further, in the above valve holder, the free end of the flange is provided with at least one fixing ear, and the fixing ear is used to cooperate with the groove of the delivery device.

[0020] Further, in the above valve stent, the fixed ear is a convex round block or square.

[0021] Further, in the above valve stent, the flange is connected at a set height position of the stent body.

[0022] Further, in the above valve stent, the stent body is arranged in a grid shape instead of the stent body in a round shape or diamond shape.

[0023] According to another aspect of the present invention, there is provided a prosthetic heart valve, including a valve support, a valve leaflet fixed to the valve support, and a skirt attached to the inner or outer surface of the valve support.

[0024] Further, in the above prosthetic heart valve, the grid of the stent body connected to the grasping ear is provided with the skirt on the inner surface.

[0025] Compared with the prior art, a valve stent provided by an embodiment of the present invention includes a stent body arranged in a grid, at least one grab ear and a flange connected to the stent body. The grasping ear is used to grasp the native leaflet, and the flange is used to tightly adhere to the left atrium opening and native leaflet when the valve stent is deployed. The outer diameter D of the flange of the embodiment of the present invention is larger than the diameter d of the connection between the flange and the main body of the bracket, so that the horizontal plane under the flange closely fits the heart's native annulus and valve leaflets, and the upturned end surface closely The inner wall of the left atrium serves as an upper limit and seal to prevent the valve stent from sliding out to the left ventricular end. In the embodiment of the present invention, when the valve stent is compressed into the sheath, the grasping ear is embedded in the grid of the stent body connected to the grasping ear to reduce the thickness of the stent after the compression and reduction of the diameter of the valve stent, which is beneficial to the valve stent The venous path intervenes in the human body, thereby reducing the diameter of the conveyor catheter, reducing the difficulty of delivery and damaging the blood vessels. In addition, the grasping ears according to the embodiments of the present invention grab the native valve leaflets while hooking the tendon cord to form a lower limit, which prevents the valve stent from being pulled out to the left atrium end due to external forces such as blood flow washing and heart compression.

Beneficial effects of invention

Brief description of the drawings

BRIEF DESCRIPTION

[0026] FIG. 1 is a front view of a prosthetic heart valve stent according to an embodiment of the present invention;

[0027] FIG. 2 is a top view of a prosthetic heart valve stent according to an embodiment of the present invention;

[0028] FIG. 3 is a schematic structural view of an embodiment of the present invention; [0029] FIG. 4 is a top view of a stent structure according to an embodiment of the present invention;

[0030] FIG. 5 is a front view of a diamond ring flange according to an embodiment of the present invention;

[0031] FIG. 6 is a plan view of a diamond ring flange according to an embodiment of the present invention;

[0032] FIG. 7 is a schematic diagram of a connection relationship between a flange and a bracket body according to an embodiment of the present invention;

[0033] FIG. 8 is a schematic diagram of a straight bar grab ear according to an embodiment of the present invention;

[0034] FIG. 9 is a schematic diagram of an ear grip of an embodiment of the present invention;

[0035] FIG. 10 is a schematic view of the cutting ear and the main body of the bracket according to an embodiment of the present invention;

[0036] FIG. 11 is a schematic diagram of grabbing the ear leaflets and hooking the tendon according to the embodiment of the present invention;

[0037] FIG. 12 is a partially enlarged schematic view at the position D of FIG. 11;

[0038] FIG. 13 is a schematic diagram of implantation of a prosthetic heart valve stent according to an embodiment of the present invention;

14 is a schematic diagram of loading a prosthetic heart valve stent according to an embodiment of the present invention;

[0040] 10-stent; 20-valve; 30-skirt; 101-flange; 102-stent body; 103-grasping ear; 104-fixed ear; 201-native valve leaflet; 202-tendon cord; 301- Left atrium; 302-left ventricle; 401-sheath; 402-fixed head.

Invention Example

Embodiments of the invention

[0041] In order to make the creative features, technical means and achievements of the present invention easy to understand, the following further describes the present invention in conjunction with specific embodiments.

[0042] As shown in FIGS. 1-2, the present invention provides a prosthetic heart valve, including a valve support 10, a valve leaflet 20 fixed on the valve support 10, and attached to the inner surface or outer surface of the valve support 10 The surface skirt 30. The valve stent 10 of the embodiment of the present invention is mainly a support positioning member for supporting structures such as valve leaflets and skirts.

[0043] Preferably, the valve stent 10 of the embodiment of the present invention is made of a metal material. Preferably, it is made of shape memory alloy. Further, the bracket 10 is formed by cutting a nickel-titanium alloy pipe.

[0044] Preferably, the valve leaflet 20 in the embodiment of the present invention is an artificial valve leaflet, which is a component used to replace the native valve leaflet for opening and closing movement and controlling the blood flow direction.

[0045] Preferably, the skirt 30 of the embodiment of the present invention is made of biological material, specifically, it can be made of polyethylene terephthalate PET, or polytetrafluoroethylene PTFE, or animal pericardium material, It is a layer of film with functions such as anti-valvular leakage. [0046] As shown in FIGS. 3-4, a valve stent 10 provided in an embodiment of the present invention includes a stent body 102 arranged in a grid, one end of the stent body 102 is fixedly connected to at least one grasping ear 103, and the other end Connected to flange 101. In a specific implementation, the grasping ear 103 is used to grasp a native valve leaflet when the valve stent is deployed, and the flange 101 is used to closely adhere to the left atrium opening and the native valve leaflet when the valve stent is deployed.

[0047] In a specific implementation, the bottom end of the grip ear 103 of the embodiment of the present invention is fixed to the bracket body 102, and the top end is outwardly bent to form a vertical rod shape, and is evenly distributed on the outer surface of the bracket body 102 in the circumferential direction. Preferably, the grabbing ear 103 is fixed to the bracket body 102 by riveting, welding, or snapping.

[0048] The relative position of the gripping ear 103 and the bracket body 102 in the embodiment of the present invention is not unique. The end of the bracket body 102 near the flange 101 is the upper end, and the end of the bracket body 102 away from the flange 101 is the lower end. The lower grid of the bracket body 102 is the bottommost grid of the bracket body 102. Preferably, the grasping ear 103 may be located on the lower end grid of the stent body 102, so that the grasping ear 103 better grasps the tendon 202 while grasping the native valve leaflet 201 to form a lower limit. The gripping ears 103 can also be located on the remaining rows of grids of the bracket body 102. During implementation, the specific position of the grasping ear 103 can be adjusted appropriately according to the actual heart anatomy and the structural design of the stent body 102.

[0049] Further, the number of grasping ears 103 in the embodiment of the present invention is not fixed, preferably, six grasping ears 103 are provided, and in implementation, each grasping ear 103 may be located on the same row of grids of the bracket body 102, or They are alternately located on different rows of grids of the bracket body 102, and can be connected to the grid nodes of the bracket body 102, and can also be connected to the grid edge bars of the bracket body 102. The row of grids described herein refers to a group of grids arranged along the circumference of the bracket body 102.

[0050] Preferably, the overall size of the grasping ear 103 of the embodiment of the present invention is smaller than the size of the mesh of the stent body 102 connected to the grasping ear 103, so that when the valve stent is compressed and contracted into the delivery catheter, the grasping ear 103 can be embedded into In the mesh space of the stent body 102 connected to it, to reduce the thickness of the stent after the compression and reduction of the diameter of the valve stent, it is helpful for the valve stent to intervene in the human body through the femoral vein path, thereby reducing the diameter of the conveyor catheter and reducing the difficulty of delivery and Damage to blood vessels. Corresponding to this, the mesh connected to the gripping ear 103 can only sew the skirt on the inner surface, but cannot sew the skirt on the outer surface. Otherwise, stitching the outer skirt will prevent the gripping ear 103 from being embedded in the connected mesh.

[0051] Preferably, the grip ear 103 of the embodiment of the present invention has various shapes, which may be a straight rod (as shown in FIG. 8) or a slightly curved wave rod (as shown in FIG. 9) to increase the grip The grasping force of the ear 103 on the native leaflet, to And improve its hooking performance to tendon. However, all of the above shapes of the grasping ear 103 need to meet the requirement that “the grasping ear 103 can be embedded in the mesh connected to it when the stent is compressed and contracted into the delivery catheter. The surface of the gripping ear 103 in this embodiment of the present invention may be a smooth surface or a rough surface. Preferably, the grasping ear 103 is provided with a texture structure. The texture structure may be set as a regular texture structure or an irregular texture structure to increase the friction between the grasping ear and the valve leaflets and tendon cords.

[0052] As shown in FIGS. 11-12, during the implementation, the cardiac native leaflet cycle repeats the opening and closing movement, and the grasping ear 103 grabs the free end of the native valve leaflet 201 that is undergoing the closing movement. At this time, due to the grasping ear 103 ’s Due to the gripping limitation, the native valve leaf 201 will not be able to perform the opening movement, and the native valve leaf 201 closely adheres to the outer surface of the stent body 102 to achieve the sealing effect and prevent the occurrence of paravalvular leakage. The grasping ear 103 of the embodiment of the present invention grabs the native valve leaf 201 and hooks the tendon 202 to form a lower limit (see the position of FIG. 12-C), which prevents the valve support from being washed by blood flow, squeezing the heart and other external forces And prolapse to the left atrium. Based on the above-mentioned fixing and sealing mechanism of the gripping ear 103, the embodiments of the present invention do not require large-scale design to obtain support like some conventional brackets, thereby ensuring the realization of a smaller diameter of the bracket body 102.

[0053] Preferably, the stent body 102 of the embodiment of the present invention has a small diameter, and the upper and lower ends have a diameter ranging from 20mm to 50mm. Optionally, the stent body 102 of the present invention can be made into a cylindrical shape with the same diameter at the upper and lower ends. The bracket body 102 is formed in an inverted trapezoid shape with an upper width and a narrow width or a trapezoid shape with an upper width and a lower width, or even a bucket shape with a convex middle portion with the same diameter at the upper and lower ends. In implementation, a shape with a narrower lower end is preferred, because under the condition of ensuring the normal operation of the artificial valve stent, the narrower the lower end of the valve stent, the less the interference with the aorta.

[0054] In the implementation, according to different design and use requirements, the embodiments of the present invention may attach the skirt 30 to the inner surface or the outer surface or both sides of the stent body 102 by means of stitching, adhesion, etc. At the same time, the interior of the stent body 102 also passes Sutures, adhesions, etc. carry artificial leaflets.

[0055] Preferably, the form and shape of the stent body 102 in the embodiments of the present invention are various. In addition to the straight cylindrical shape shown in the figure, the contour of the stent body 102 can be changed to a trapezoid, an inverted trapezoid, etc. according to the heart anatomy. form. The grid shape of the bracket body 102 may also be various suitable shapes such as a circle and a diamond shape. The shape and size of the grid may be uniform or non-uniform.

[0056] In the embodiment of the present invention, when the function of the stent body 102 is ensured to be normal and complete, the flexible setting of the stent body 102 can be achieved through various forms such as materials, processes, and structures.

[0057] In the implementation of the present invention, after the valve stent is implanted, the stent body 102 is precisely attached to the native heart valve leaflet in the circumferential direction Close, play a sealing role. The diameter of the stent body 102 is small, and the space required for the leaflet to perform the opening and closing movement is small. Accordingly, the area of the artificial leaflet is reduced, and the fatigue resistance of the valve stent is improved.

[0058] In the implementation, the embodiment of the present invention does not affect the normal function of the heart, the upper end portion of the stent body 102 at the left atrium end protrudes an appropriate height, can be part of the artificial valve leaf opening and closing height required to distribute to the left atrium End, thereby reducing the height of the subvalvular, can also reduce the impact of the valve stent on the aortic valve, and reduce the risk of left ventricular outflow tract obstruction.

[0059] Further, in the embodiment of the present invention, the outer diameter D of the flange 101 is larger than the diameter d of the connection between the flange 101 and the stent body 102, so that the flange 101 is tightly attached to the heart annulus and valve The leaf, the edge upturned end surface is close to the inner wall of the left atrium, and serves as an upper limit and a seal to prevent the valve stent from sliding out to the left ventricular end.

[0060] Preferably, the outer diameter D at the edge of the flange 101 of the present invention is the maximum diameter of the flange, 30mm <D <80mm; the diameter d of the connection between the flange 101 and the bracket body 102 is The minimum diameter of the flange 101 is 20mmSd <50mm.

[0061] In practice, the minimum diameter of the flange 101 is the diameter at the upper end of the bracket body 102. The flange of the embodiment of the invention

The diameter of the connection between 101 and the main body 102 of the stent is not necessarily equal. If they are not equal, you can fill the gap between the two by connecting the skirt, pericardium and other connecting objects. According to different design and usage requirements, the present invention can also attach the skirt 30 to the inner surface or outer surface of the flange 101 or both sides by means of stitching, adhesion and the like.

[0062] Preferably, the flange 101 of the embodiment of the present invention is connected to the set height position of the bracket body 102. As shown in FIG. 7, the upper end of the bracket body 102 in the embodiment of the present invention can properly cross the lower plane of the flange 101, that is, the connection point between the flange 101 and the bracket body 102 is not necessarily an end, and the flange 101 can also be connected to the bracket body 102 Any suitable height position, that is, after the valve stent is implanted into the heart, the stent body 102 is partially exposed in the left atrium, which reduces the height of the valve stent below the left ventricle and reduces the valve stent's ejection of the aorta influences. At the same time, the embodiments of the present invention can also ensure that the stent body 102 and the flange 101 do not overlap with each other when the diameter of the stent body 102 and the flange 101 are compressed by the means such as optimized structural design, which increases the thickness of the valve stent after the crush .

[0063] Preferably, the flange 101 of the present invention is made of a flexible material. In the embodiment of the present invention, under the condition that the function of the flange 101 is normal and complete, the flexible setting of the flange 101 can be achieved through various forms of materials, processes, structures, etc., to ensure that the wide flange can be compressed and shrunk into the sheath , For follow-up transfemoral vein intervention [0064] In the implementation of the present invention, after the valve stent is implanted, the grasping ear 103 will be subjected to the force of the native tissue toward the left ventricle when grasping the valve leaflet and hooking the tendon, because the grasping ear 103 is connected to the stent body 102, As a result, the entire stent 10 will be affected by this force and tend to move toward the left ventricle. At this time, due to the reaction force, the flange 101 closely fits the native annulus and leaflet of the heart (see Figure 13-A At the end), the edge upturned end surface is closely attached to the inner wall of the left atrium (see position in Figure 13-B), which acts as an upper limit and seals to prevent the valve stent 10 from sliding out to the left ventricular end. The flange 101 of the present invention is relatively wide, which can enhance the sealing performance of the valve stent 10 in the left atrium, and is more conducive to preventing the occurrence of paravalvular leakage.

[0065] From the above, the positioning, anchoring and sealing of the stent according to the embodiment of the present invention is achieved by the upper limit of the flange 101, the lower limit of the grasping ear 103, and the grasping of the leaflet by the grasping ear 103, while some traditional stents rely on oversize It is designed to obtain the radial support force to be supported at the native petal, and the structural rigidity required by the stent is strong. Therefore, in contrast, the flexible arrangement of the stent in the embodiment of the present invention is more advantageous for the valve stent to intervene in the human body through the femoral vein path, and the valve stent can be compressed and held smaller, and the diameter of the adapted delivery catheter is smaller. Reduced the difficulty of delivery and damage to blood vessels. Further, there are various manufacturing methods of the flange 101 in the embodiment of the present invention, and the present invention provides the following manufacturing methods:

[0066] 1. The flange 101 and the bracket body 102 are produced by cutting together. Specifically, the metal tube, such as a nickel-titanium alloy pipe, is cut by laser, and the flange 101 and the bracket body 102 are simultaneously cut into the bracket prototype, and then passed The heat treatment diameter expansion qualitative process is made into the final form.

[0067] Second, the flange 101 and the bracket body 102 are separately cut and manufactured. Specifically, the metal tube, such as a nickel-titanium alloy tube, is cut by laser to separate the flange 101 and the bracket body 102 into a prototype bracket, and then separately The final shape is made by the heat treatment diameter expansion qualitative process, and finally the flange 101 and the bracket body 102 are connected into one body.

[0068] It should be noted that the manufacturing method of the flange 101 is not limited to the above method, and other methods that can make the flange 101 are applicable to the embodiments of the present invention.

[0069] Preferably, the “laser cut metal pipe” in the above two production methods can also be replaced with various suitable methods such as “nickel-titanium wire braiding”, “3D printing” and the like.

[0070] Preferably, the shape of the flange 101 of the embodiment of the present invention is diverse, in addition to the grid structure shown in the figure, the outline of the flange 101 can also be designed in the form of divergent rods, divergent branches and the like. If the flange 101 is designed as a grid The shape of the grid can be various suitable shapes such as circles and diamonds (as shown in Figure 5-6). The shape and size of the grid can be uniform or non-uniform. The rods and rings can be connected to each other or independent of each other

[0071] Preferably, the connection method of the flange 101 of the present invention and the bracket body 102 includes, but is not limited to, one or more of the following: rope sewing, skirt connection, riveting or welding.

[0072] Further, the manufacturing method of the gripping ear 103 of the present invention is not unique, for example, by cutting the pipe material by laser, the gripping ear 103 and the bracket body 102 are simultaneously cut out of the prototype of the bracket, that is, the grid gap of the gripping ear 103 needs to be provided In addition, an additional rod is cut out, and then the final shape is made by heat treatment, diameter expansion and qualitative processes. Of course, the gripping ear 103 and the bracket body 102 can also be cut separately, and then the gripping ear 103 and the bracket body 102 can be connected by riveting, welding, snapping, or other suitable methods, but no matter what process, all When crimping into the delivery catheter, the grasping ear 103 can be embedded in the mesh connected to it, as shown in Figure 10

[0073] Further, as shown in FIG. 3, the free end of the flange 101 of the embodiment of the present invention is provided with at least one fixing ear 104, and the fixing ear 104 fixes the bracket and the delivery device.

[0074] In the implementation, when the bracket is actually manufactured, some fixing ears 104 may be additionally designed on the upturned end of the flange 101, and the fixing ears 104 are mainly used for snapping on a structure matching it in the conveying device, so that The stent can be pulled or pushed by the delivery device. Preferably, the fixing ear 104 may be a protruding round block or a square, or may be a round hole cut in the support rod, and other suitable forms. Preferably, the number of the fixed ears 104 is at least 3, or a multiple of 3, which may be 3, 6, 9 and so on. It should be noted that the fixing ear 104 according to the embodiment of the present invention may also be designed at other suitable positions of the valve support according to different delivery device structures.

[0075] Since the tricuspid valve serves as the atrioventricular valve of the right heart, its structure is similar to the mitral valve, and also includes valve leaflets, annulus, chordae, and papillary muscles. Therefore, the heart valve stent replacing the native mitral valve in the embodiment of the present invention can also be used to replace the native tricuspid valve, and the valve stent size is different according to the native valve size.

[0076] According to another aspect of the present invention, a prosthetic heart valve stent delivery device is provided, which includes a sheath 401 that wraps a compression valve stent and a fixed head 402 that fixes the stent 10. Preferably, the groove on the fixing head 402 matches the fixing ear 104 of the bracket 10.

[0077] In practice, the loading of the valve stent in the embodiment of the present invention is performed in an extracorporeal ice water bath. As shown in Fig. 14, the valve holder is pressed and held in ice water below 5 ° C, and the fixing ear 104 is snapped and fixed in the groove of the fixing head 402 In this process, the auxiliary device, such as a loading tool, controls the handle of the conveyor to gradually retract the valve stent into the sheath 401. After loading, the conveyor passes through the guide wire, along the femoral vein to the position of the diseased mitral valve, and selects the appropriate release position to start the release.

[0078] The valve stent release process of the embodiment of the present invention includes the following stages.

[0079] The first stage: after the control handle is withdrawn, the sheath tube 401 is released, and the grasping ear 103 is released first, and then the sheath tube 401 is removed afterwards, and a part of the stent body 102 is released. , So that the grasping ear 103 can pass through enough tendons to grasp the valve leaflet when the native mitral valve leaflet of the heart is closed.

[0080] The second stage: push the conveyor downward, adjust the angle of the grasping ear 103, grasp the leaflets, and hook the tendon.

[0081] The third stage: continue to withdraw the sheath tube 401, adjust the position and depth of the valve holder, adjust the relative position of the flange 101 and the native heart valve leaflet, completely release the flange 101, withdraw the conveyor, and the valve holder 10 begins to work normally

[0082] In summary, the present invention is based on a single-layer stent as the premise of the small-diameter stent body, compatible with the dual advantages of easy compression delivery and reducing the impact of the valve stent on the aortic valve. The ear grab of the present invention has a small volume, and the grid space can be used to hold the ear during crimping, which reduces the thickness of the stent of the valve stent after crimping and shrinking, and is more conducive to the intervention of the valve stent through the femoral vein path. The diameter of the conveyor catheter reduces the difficulty of delivery and damage to blood vessels. The upper end of the stent body of the present invention can properly cross the lower plane of the flange and be exposed in the left atrium, thereby reducing the height of the subvalvular, mitigating the effects of papillary muscle intervention, aortic sinus interference, and left ventricular outflow tract obstruction.

[0083] The basic principles, main features and advantages of the present invention are shown and described above. Those skilled in the art should understand that the present invention is not limited by the above-mentioned embodiments. The above-mentioned embodiments and the description only describe the principles of the present invention, and the present invention will have various aspects without departing from the spirit and scope of the present invention. Variations and improvements that fall within the scope of the claimed invention. The scope of protection required by the present invention is defined by the appended claims and their equivalents.

Claims

[Claim 1] A valve stent, characterized by comprising a stent body (102) arranged in a grid

, At least one grab ear (103) and flange (101) connected to the bracket body (102), the outer diameter D of the flange (101) is greater than the flange (101) and the bracket body ( 102) The diameter d of the connection, when the valve stent is compressed into the sheath, the grasping ear (103) is embedded in the grid of the stent body (102) connected to the grasping ear (103).

[Claim 2] The valve stent according to claim 1, characterized in that the diameter of the upper or lower end of the stent body (102) ranges from 20 mm to 50 mm.

[Claim 3] The valve stent according to claim 1, characterized in that the outer diameter of the flange (101) is in the range of 30 mm ^ D ^ 80 mm.

[Claim 4] The valve stent according to claim 3, characterized in that the diameter of the connection between the flange (101) and the stent body (102) is 20 mm ^ d ^ 50 mm.

[Claim 5] The valve stent according to any one of claims 1-4, characterized in that one end of the grasping ear (103) is fixed to the stent body (102), and the other end is radially outwardly warped.

[Claim 6] The valve stent according to claim 5, characterized in that the grasping ear (103) is a straight rod or a curved wave rod.

[Claim 7] The valve stent according to claim 6, characterized in that a texture structure is provided on the grasping ear (103).

[Claim 8] The valve stent according to claim 1, characterized in that the grasping ear (103) is connected to a grid node of the stent body (102), or is connected to a mesh node of the stent body (102) The grid edge bars are connected.

[Claim 9] The valve stent according to claim 1, characterized in that the grasping ear (103) is located on the lower end grid of the stent body (102).

[Claim 10] The valve support according to claim 1, characterized in that at least one fixing ear (104) is provided at the free end of the flange (101), and the fixing ear (104) is used for The grooves of the conveyor match.

[Claim 11] The valve stent according to claim 10, wherein the fixing ear (104) is a convex round block or square.

[Claim 12] The valve stent according to claim 1, wherein the flange (101) is connected to a set height position of the stent body (102).

[Claim 13] The valve stent according to claim 1, wherein the shape of the mesh is a circle or a diamond.

[Claim 14] A prosthetic heart valve, characterized by comprising the valve support according to any one of claims 1-13, further comprising a valve leaflet (20) fixed on the valve support, and attached to the valve Skirt (30) on the inner or outer surface of the bracket.

[Claim 15] The prosthetic heart valve according to claim 14, characterized in that, with the grasping ear (10

3) The grid of the connected bracket body (102) sets the skirt on the inner surface.