CN212395131U - Artificial heart valve - Google Patents

Abstract

The utility model discloses a heart valve prosthesis, which comprises a stent main body for supporting a valve leaflet and an anchoring frame for anchoring the stent main body to a valve ring; the anchoring frame is arranged at a preset position close to the outflow channel side, the support body is arranged at a preset position outside the anchoring frame and far away from the outflow channel side, and the anchoring frame is abutted and connected with the support body. Compared with a single-layer bracket, the bracket main body and the anchoring frame of the utility model are respectively used for supporting and anchoring the valve leaflet, and the radial size of the bracket main body is smaller, so that the size of the artificial valve leaflet is smaller, and the fatigue resistance of the valve leaflet is improved; the size of the leaflet becomes smaller so the leaflet material is correspondingly reduced; the size of the anchoring frame is reduced relative to an inside-outside nested double layer stent, so that less material is used for the anchoring frame and less skirt material is used for the anchoring frame; the less material, the smaller the size after crimping, and the easier it is to crimp and load.

Description

Artificial heart valve

Technical Field

The utility model relates to the technical field of medical equipment, concretely relates to a heart valve prosthesis for implanting in heart.

Background

The heart contains four chambers, the left atrium and left ventricle being located on the left side of the heart, and the right atrium and right ventricle being located on the right side of the heart. A ventricular inflow channel is formed between the atrium and the ventricle, a left ventricular outflow channel is formed between the left ventricle and the aorta, and a right ventricular outflow channel is formed between the right ventricle and the pulmonary artery. Valves with the function of 'one-way valves' are arranged at the inflow channel and the outflow channel of the chamber, so that the normal flow of blood in the heart cavity is ensured. When a problem occurs with the valve, the hemodynamics of the heart change and the heart functions abnormally, which is called valvular heart disease.

Mitral regurgitation can lead to myocardial remodeling, progressive enlargement of the ventricles, and ultimately heart failure. Transcatheter mitral valve replacement surgery (TMVR) employs a catheter-based approach to extracorporeally compress a prosthetic valve to a delivery system for delivery to the mitral annulus of a human subject, and release-secure the prosthetic valve at the mitral annulus to replace the native valve. Compared with the surgical operation, the TMVR does not need an extracorporeal circulation auxiliary device, has small wound and quick recovery of the patient, and can obviously improve the hemodynamics index of the postoperative patient.

Although mitral valve replacement techniques have been developed at a rapid pace, there are several recognized challenges in the design of valves, such as:

1. the native annulus of the mitral valve is larger in diameter compared to the aortic valve, and accordingly, the leaflet area of the prosthetic valve is also large. The larger the leaflet area, the worse the fatigue resistance.

2. Aiming at the existing mitral valve prosthesis, the diameter of the delivery catheter is large, and the delivery difficulty and the risk of blood vessel injury are increased.

3. The atrioventricular valve assembly has a complex structure, and if the height below the prosthetic valve is too high, the native cardiac structure and cardiac function are affected, and the heart tissue such as papillary muscles is touched to cause abnormal conditions, and meanwhile, left ventricular outflow tract obstruction (LVOT) is easily caused, and adverse postoperative influence is induced.

Tricuspid valves also suffer from sub-valvular height overshoot and blockage of the right ventricular outflow tract.

SUMMERY OF THE UTILITY MODEL

The utility model provides a heart valve prosthesis, which can solve the defects in the prior art.

The technical scheme of the utility model as follows:

a prosthetic heart valve comprising a stent body for supporting a prosthetic leaflet, and an anchoring frame for anchoring the stent body at an annulus; the anchoring frame is arranged at a predetermined position close to the outflow channel side, the stent main body is arranged at a predetermined position outside the anchoring frame and away from the outflow channel side, and the anchoring frame abuts against and is connected with the stent main body.

The heart valve is implanted at the valve ring and is used for replacing the native valve leaflets to realize the function of opening and closing the blood channel. Compared with the existing single-layer stent, the stent main body and the anchoring frame are respectively used for supporting and anchoring the valve leaflet, and the radial size of the stent main body is smaller, so that the size of the artificial valve leaflet placed on the stent main body is smaller, and the fatigue resistance of the valve leaflet is improved; the size of the leaflet becomes smaller so the leaflet material is correspondingly reduced; compared with the traditional double-layer support which is nested inside and outside, the support main body and the anchoring frame of the utility model are of a structure which is connected in parallel from left to right, and the size of the anchoring frame is relatively smaller, so that the materials of the anchoring frame and the skirt materials covered on the anchoring frame are less; the less material, the smaller the size after crimping, and the easier it is to crimp and load.

Research shows that if the artificial mitral valve can drive blood to flow along the side wall of the ventricle, the blood can turn smoothly and generate a large vortex, so that the blood is shot to the aorta and then flows to the whole body. In left and right heart valves, the leaflets are located on the stent body, and the stent body is more offset to the ventricular wall side, so that blood flow tends to flow along the ventricular sidewall, which is more beneficial to keep the natural 'blood flow vortex' of the left atrium, thereby promoting the recovery of ventricular function, especially in vulnerable patients with severely damaged heart conditions. Preferably, the outer peripheral side of the anchor frame and the outer peripheral side of the stent body abut against each other and are connected at the abutting place. With such a structure, the anchoring frame and the stent main body can be in surface-to-surface contact, so that the connection between the anchoring frame and the stent main body is more stable.

Preferably, the abutting part of the anchoring frame and the stent main body is of a single-layer structure, so that the material of the heart valve can be saved.

Preferably, the anchoring frame or the stent body is a non-closed structure. The non-enclosing structure can reduce the material of the anchoring frame or the stent body.

Preferably, the anchoring frame is of an open structure along the axial direction, the anchoring frame abuts against the periphery of the support main body at the opening, and the open end of the anchoring frame is connected with the support main body; or the support main body is of an opening structure along the axial direction, the support main body is abutted to the periphery of the anchoring frame at the opening, and the opening end of the support main body is connected with the anchoring frame. The opening structure arranged along the axial direction enables the material of the valve support and the skirt material coated on the valve support to be further reduced on the premise of not influencing the functions of the anchoring frame or the support main body, and the valve prosthesis is easier to press and release.

Preferably, at the abutting position, one part of the anchoring frame is of an open structure, the part of the support main body abutting against the anchoring frame is of a non-open structure, the other part of the anchoring frame is of a non-open structure, and the part of the support main body abutting against the support main body is of an open structure.

Preferably, the anchoring frame has a notch structure, the notch structure is located at the outflow section of the anchoring frame, and the notch structure is configured to face the direction of the outflow tract. The notch structure prevents the anchoring frame from crossing the ventricular wall, and therefore the prosthetic heart valve does not overly urge the ventricular wall against the right side of the aortic valve or the left side of the pulmonary valve. Meanwhile, the gap structure arranged on the outflow section reduces the height under the valve of the frame part, and reduces the risk of outflow tract blockage.

Preferably, the valve comprises a prosthetic valve leaflet which is arranged on the main body part. The leaflets are connected at one end to the body portion with a commissure between the free ends of the leaflets.

Under the working state of the valve, the artificial valve leaf replaces the native valve leaf to realize the function of opening and closing the blood channel.

In order to prevent the heart valve from moving relatively in the delivery system, so that the heart valve can be smoothly implanted into a preset position in the conveying process and can be separated and released, the heart valve also comprises at least one connecting lug, and the heart valve is connected with the delivery system through the connecting lug; the connecting lug is arranged at the end part of the inflow section or the end part of the outflow section of the bracket main body, or the connecting lug is arranged at the end part of the inflow section or the end part of the outflow section of the anchoring frame.

Preferably, the heart valve further comprises a skirt for sealing. The shirt rim is used for realizing sealed function, guarantees that the single passageway of blood can effectively prevent perivalvular leakage and palirrhea for flowing to the outflow way end of valve prosthesis from the inflow way end of heart valve.

Compared with the prior art, the beneficial effects of the utility model are as follows:

firstly, compared with the structure of the existing single-layer stent, the stent main body and the anchoring frame of the utility model are respectively used for supporting and anchoring the valve leaflets, and the radial size of the stent main body is smaller, so that the size of the artificial valve leaflet is smaller, and the fatigue resistance of the valve leaflet is improved; the size of the leaflet becomes smaller so leaflet material is also reduced; compared with the traditional internally and externally nested double-layer bracket, the bracket main body and the anchoring frame of the utility model adopt a structure of parallel connection from left to right, the size of the anchoring frame is reduced, and therefore, the materials of the anchoring frame and the skirt materials are less; the less material, the smaller the size after crimping, and the easier it is to crimp and load. In addition, in left and right heart valves, the leaflets are located on the stent body, and the stent body is more offset to the ventricular wall side, so that blood flow tends to flow along the ventricular sidewall, which is more beneficial to maintain the natural "blood flow vortex" in the left atrium, thereby promoting the recovery of ventricular function, especially in vulnerable patients with severely impaired heart conditions.

Second, the utility model discloses a structure of side by side connection about support subject and anchor frame adopt makes and forms face-to-face contact between support subject, the anchor frame, therefore the connection between the two is more firm.

Thirdly, the anchoring frame of the utility model is also provided with a gap structure, when the gap structure faces to the outflow tract, the gap structure ensures that the anchoring frame can not cross over the ventricular wall surface, so that the artificial heart valve can not lead the ventricular wall to be excessively propped against the right side of the aortic valve or the left side of the pulmonary valve, and the influence of the artificial heart valve body on the heart function can be reduced; when the anchoring frame is of a non-closed structure along the axial direction, the opening structure arranged along the axial direction enables the material of the valve support and the skirt material coated on the valve support to be further reduced on the premise of not influencing the functions of the anchoring frame or the support main body, and the valve prosthesis is easier to press and release.

Of course, it is not necessary for any particular product to achieve all of the above-described advantages at the same time.

Drawings

Fig. 1 is a partial schematic structural view of a heart valve prosthesis according to embodiment 1 of the present invention;

fig. 2 is a schematic top view of a prosthetic heart valve according to example 1 of the present invention;

fig. 3 is a schematic perspective view of a prosthetic heart valve according to embodiment 1 of the present invention;

fig. 4 is a schematic structural view of an anchoring frame according to embodiment 1 of the present invention;

fig. 5 is a schematic top view of an anchoring frame according to embodiment 1 of the present invention;

fig. 6 is another schematic perspective view of a prosthetic heart valve according to example 1 of the present invention;

fig. 7 is another schematic structural view of the anchoring frame according to embodiment 1 of the present invention;

fig. 8 is a schematic structural view of a stent main body according to embodiment 1 of the present invention;

fig. 9 is a schematic top view of a holder main body according to embodiment 1 of the present invention;

fig. 10 is a schematic structural view of another stent main body according to embodiment 1 of the present invention;

fig. 11 is a schematic top view of a further bracket body according to embodiment 1 of the present invention;

fig. 12 is a schematic view of a prosthetic heart valve according to example 1 of the present invention implanted in a heart;

fig. 13 is a schematic view of a prosthetic heart valve according to example 3 of the present invention;

figure 14 is a schematic view of another prosthetic heart valve of example 3 of the present invention;

fig. 15 is a schematic view of a further prosthetic heart valve according to example 3 of the present invention;

fig. 16 is a schematic perspective view of a prosthetic heart valve according to example 4 of the present invention.

Reference numerals: a holder main body 110; a main body inflow section 111; a body transition section 112; a main body outflow section 113; a hanging lug 114; an anchor frame 210; an inflow section 211; a transition section 212; an outflow section 213; a securing ear 214; an abutment 215; a notch structure 216; a frame open end 300; the body open end 301.

Detailed Description

To more clearly describe the structural features of the present invention, the terms "proximal" and "distal" are used as the terms of orientation, wherein "proximal" refers to the end that is near the apex of the heart during the operation; "distal" means the end distal to the apex of the heart. "heart valve" and "prosthetic heart valve" have the same meaning.

As described herein, the "outflow tract" refers to the left ventricular outflow tract when the prosthetic heart valve is a mitral valve, and the "outflow tract" refers to the right ventricular outflow tract when the prosthetic heart valve is a tricuspid valve. As used herein, "round-like" refers to a hexagon and a polygon having six or more sides, and is approximately circular in nature, and "flower-like" refers to the shape of the outer edge of a petal. As described herein, square includes rectangular and square.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", and the like indicate orientations or positional relationships based on the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the device or element referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "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 in specific cases to those skilled in the art.

In the description of the present invention, it is noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

The present invention will be further described with reference to the following specific examples. It should be understood that these examples are only for illustrating the present invention, and are not intended to limit the scope of the present invention. In practical applications, the improvement and adjustment made by those skilled in the art according to the present invention still belong to the protection scope of the present invention.

Example 1

The present embodiment provides a mitral valve prosthesis, which is a schematic view of the heart valve of the present embodiment, referring to fig. 1-12, wherein the heart valve includes a stent main body 110 for supporting a prosthetic leaflet, and an anchoring frame 210 for anchoring the stent main body 110 to an annulus; the anchor frame 210 is disposed at a predetermined position close to the left ventricular outflow tract, the stent body 110 is disposed at a predetermined position away from the left ventricular outflow tract outside the anchor frame 210, and the anchor frame 210 abuts against and is connected to the stent body 110.

At least two artificial leaflets, which may be the same or different in number from the native leaflets, each disposed along the circumferential direction of the stent body 110, are configured in the stent body 110. The leaflets may be secured to the stent body 110 by direct or indirect attachment, with the free ends of the leaflets engaging one another. The valve leaf is made of animal pericardium or high molecular material, the animal pericardium is pig pericardium or cattle pericardium, and the high molecular material is PET or PTFE. The number of the artificial valve leaflets and the material of the valve leaflets can be set according to the actual clinical needs, and the details are not repeated here.

In this embodiment, the stent main body 110 and the anchoring frame 210 are connected in parallel in the left-right direction, and compared to the existing single-layer stent, the stent main body 110 and the anchoring frame 210 are respectively used for supporting and anchoring the leaflet, and the radial size of the stent main body 110 is small, so that the size of the artificial leaflet is small, and the fatigue resistance of the leaflet is improved; the leaflet becomes smaller in size and therefore less leaflet material. The anchor frame 210 and skirt are less material, the smaller the size after crimping, and the easier to crimp and load than conventional nested double layer stents.

Research shows that if the artificial mitral valve can drive blood to flow along the side wall of the ventricle, the blood can turn smoothly and generate a large vortex, so that the blood is shot to the aorta and then flows to the whole body. In left and right heart valves, the leaflets are located on the stent body, and the stent body is more offset to the ventricular wall side, so that blood flow tends to flow along the ventricular sidewall, which is more beneficial to keep the natural 'blood flow vortex' of the left atrium, thereby promoting the recovery of ventricular function, especially in vulnerable patients with severely damaged heart conditions. In the present embodiment, the outer peripheral side of the anchor frame 210 and the outer peripheral side of the stent body 110 abut against each other and are connected at the abutting portion 215. Referring to fig. 1, 2, 3, 6, wherein fig. 3, 6 are schematic perspective views of a prosthetic heart valve, respectively. The stent body 110 is a cylinder, and the anchor frame 210 and the stent body 110 are abutted from the distal edge to the proximal edge and connected at an abutment 215. The stent body 110 and the anchoring frame 210 are in surface-to-surface contact with each other, so that the connection therebetween is more stable. Of course, in other embodiments, the stent body 110 and the anchoring frame 210 may be connected in abutment at a predetermined position between the two ends. The region of leaning against between the support main body 110 and the anchoring frame 210, the leaning against area, the connection site between the support main body 110 and the anchoring frame 210 should be selected according to the actual requirement, and is not used for limiting the protection scope of the present invention.

The anchoring frame 210 includes an inflow section 211, a transition section 212, and an outflow section 213, the inflow section 211 being secured within the left atrium, the transition section 212 being secured at the annulus, and the outflow section 213 extending into the left ventricle.

With continued reference to fig. 1, 2, 4, 6, 7, in a preferred embodiment, on the side proximal to the left ventricular outflow tract, the outflow section 213 is configured to extend away from the left ventricular outflow tract. When the heart valve is implanted, the outflow section 213 of the anchoring frame 210 gradually moves away from the left ventricular outflow tract, so that the influence of the heart valve of the present embodiment on the heart function can be reduced, and the conduction block can be prevented.

In this embodiment, the distance between the outflow section 213 and the axial center of the stent main body 110 is R on the side close to the outflow tract of the left ventricle, wherein R gradually decreases in a linear manner from the distal end to the proximal end, as shown in fig. 6, and the outflow section 213 is a slope. Of course, in other embodiments, R may also be selected to taper in a non-linear manner, such as an arcuate surface, again to reduce the risk of left ventricular outflow tract occlusion.

With continued reference to FIG. 7, on the side of the left ventricular outflow tract, the tangent to the outflow section 213 makes an acute angle α with the axial direction. If the angle α is too small, the outflow section 213 deviates too little from the outflow channel, increasing the risk of blockage of the outflow channel, and if it is too large, increasing the resistance to squeezing, therefore the angle α is preferably in the range of 30 ° to 60 °.

Referring to fig. 8, the stent body 110 in this embodiment is a cylinder including a body inflow section 111, a body transition section 112, and a body outflow section 113. Of course, in other embodiments, the stent body 110 may also be an elliptical cylinder (as shown in fig. 10), a cone, or a combination of a cylinder and a cone. In this embodiment, the cross-section of the stent body 110 is a circle (as shown in fig. 9), and in other embodiments, the cross-section of the stent body 110 may be configured as a quasi-circle, a D-shape, a flower shape, or a combination thereof. As shown in fig. 11, the stent body 110 has a cross-section in the shape of a flower.

The support main body 110 is a net structure formed by a plurality of rows of units, the forming units of the embodiment are diamond-shaped structures, and the diamond-shaped net surface has the advantages of simple forming process and smoother net surface. In other alternative embodiments, the constituent units may also be triangular, square, pentagonal, drop-shaped, etc. mesh units that may form a closed shape. The stent main body 110 is used to fix the valve leaflet, so the specific shape and the shape of the constituent unit can be selected according to actual requirements, and is not used to limit the protection scope of the present invention.

With continued reference to fig. 8 and 10, the proximal end of the main body outflow section 113 of the stent main body 110 is further provided with a hanging lug 114, and the hanging lug 114 is used for connecting with a delivery system to ensure that the heart valve is loaded into the delivery system, released and separated from the delivery system, and the relative position of the valve and the delivery system is unchanged during the delivery process. Of course, in other embodiments, the hanging lug 114 can also be provided at the distal end of the main body inflow section 111, or at both ends of the stent main body 110.

Since the heart valve is implanted into the body through the delivery system, the stent body 110 should have a certain elastic deformation capability and be pressed and held in the delivery system during delivery. The stent main body 110 of this embodiment is made of nickel-titanium alloy tubes by cutting, the outer diameter of the tubes is 5-15 mm, and the diameter after shaping is selected according to actual needs. In other embodiments, the material of the stent body 110 also includes an elastically or plastically deformable material, such as a balloon expandable, or may be a shape memory alloy that is responsive to temperature changes to transition between a contracted delivery state and an expanded deployed state. In particular, the stent body 110 may be made of, for example, nitinol, titanium alloy, cobalt-chromium alloy, MP35n, 316 stainless steel, L605, Phynox/Elgiloy, platinum-chromium, or other biocompatible metals as known to those skilled in the art.

With continued reference to fig. 4, which is a structural schematic view of the anchor frame 210 of the present embodiment, the outer circumferential side of the anchor frame 210 may be previously configured to have the same curvature as the outer circumferential side of the stent body 110, i.e., configured to be partially circumferentially recessed toward the center, and then fixed to the outer circumference of the stent body 1.

In an alternative embodiment, the anchoring frame 210 is a cylinder, the anchoring frame 210 is connected to the outer periphery of the stent main body 110, and after the connection is completed, the stent main body 110 and the anchoring frame 210 form a structure abutting against each other. The anchoring frame 210 may be configured as a cylinder, an elliptical cylinder, a cone, or a combination of a cylinder and a vertebral body. The cross-sectional shape of the anchor frame 210 may be circular, D-shaped, circular-like, flower-shaped, or other irregular shapes, or a combination of these shapes.

The anchoring frame 210 is a net structure composed of a plurality of rows of cells, which in this embodiment are diamond-shaped cells. Of course, in other embodiments, the cells may also be triangular, square, pentagonal, quasi-circular, drop-shaped, etc. mesh cells that may form a closed shape. The shape, number and arrangement of the anchoring frame 210 should be selected according to actual needs, and are not limited herein.

In an alternative embodiment, the proximal end of the outflow section 213 of the anchor frame 210 is further provided with a retention tab 214, and the retention tab 214 is adapted to couple to a delivery system to ensure that the heart valve is loaded into the delivery system, released from the delivery system, and the valve remains in place relative to the delivery system during delivery. Of course, in other embodiments, the securing ears 214 may also be provided at the distal end of the inflow section 211, or at both ends of the anchoring frame 210.

Since the heart valve is crimped into the delivery system for delivery, the anchoring frame 210 should be less rigid than the stent body 110. Preferably, the anchoring frame 210 of the present embodiment is woven from nitinol, and the weaving process provides the anchoring frame 210 with good deformability and is easy to hold and transport. Of course, in other embodiments, the anchor frame 210 may also be of an elastically or plastically deformable material, such as a balloon expandable, or may be a shape memory alloy that is responsive to temperature changes to transition between a contracted delivery state and an expanded deployed state. Such as with, for example, nitinol, titanium alloy, cobalt-chromium alloy, MP35n, 316 stainless steel, L605, Phynox/Elgiloy, platinum-chromium, or other biocompatible metals as known to those skilled in the art.

In this embodiment, the contact points of the stent body 110 and the anchoring frame 210 are connected, specifically, the connection may be performed by riveting, welding, snapping, and sewing, and a suitable connection manner may be selected according to the materials of the stent body 110 and the anchoring frame 210.

Further, the heart valve of this embodiment further includes a skirt for sealing. The skirts may be disposed on the inner and outer surfaces of the stent body 110, or both, or on the inner and outer surfaces of the anchor frame 210, or both. The shirt rim is used for realizing sealed function, guarantees that the single passageway of blood can effectively prevent perivalvular leakage and palirrhea for flowing to the outflow way end of valve prosthesis from the inflow way end of heart valve. The skirt is made of animal pericardium or biocompatible polymer material, the animal pericardium is pig pericardium or bovine pericardium, and the biocompatible polymer material is PET or PTFE. The area of skirt deployment, the deployment area and the materials should be set according to the actual clinical requirements and are not limited here.

In this embodiment, the anchoring form of the valve prosthesis is not limited, and flanges may be provided on the stent body 110 and the anchoring frame 210, and the anchoring form of Oversize may be adopted; the stent body 110 and the anchoring frame 210 may be provided with anchoring structures such as spines and flukes for grasping native tissues, or may be fixed by anchoring tethers to the ventricular wall, or may be anchored by a combination of various methods.

Example 2

The present embodiment provides a tricuspid prosthetic heart valve, which has a structure similar to that of embodiment 1, except that the stent body 110 of the present embodiment is implanted at an annulus within the right ventricular outflow tract, and the anchor frame 210 is fixed at a predetermined position near the right ventricular outflow tract.

To reduce the effect of the heart valve on the right ventricular outflow tract, the outflow section 213 is positioned progressively further away from the right ventricular outflow tract, thereby reducing the risk of occlusion of the right ventricular outflow tract.

Example 3

The present embodiment provides a heart valve prosthesis, which is an improvement over embodiment 1 or embodiment 2, wherein the abutting part 215 of the anchor frame 210 and the stent main body 110 is a single-layer structure.

In one embodiment, see fig. 13, which is a schematic view of the prosthetic heart valve of the present embodiment, wherein the anchoring frame 210 is a non-occluding structure. That is, the anchor frame 210 has an open structure along the axial direction, and the cross section thereof is C-shaped, and the open end of the anchor frame 210 along the axial direction is a frame open end 300, and the frame open end 300 abuts against and is connected to the outer periphery of the holder main body 110.

In another embodiment, referring to fig. 14, a schematic diagram of the prosthetic heart valve of the present embodiment is shown, wherein the stent body 110 is a non-closed structure, the stent body 110 is an open structure along the axial direction, and has a C-shaped cross section, the open end of the stent body 110 is a body open end 301, and the body open end 301 abuts against and is connected to the outer circumference of the anchoring frame 210.

In another alternative embodiment, at the abutting portion 215, a portion of the anchor frame 210 is in a non-closed configuration, while a portion of the bracket body 110 abutting against the same is in a closed configuration, and another portion of the anchor frame 210 is in a closed configuration, while a portion of the bracket body 110 abutting against the same is in a non-closed configuration. Referring to fig. 15, which is a schematic perspective view of the heart valve of the present embodiment, the proximal end of the anchor frame 210 is opened at a predetermined position, and the distal end of the stent body 110 is opened at a predetermined position, wherein the frame open end 300 abuts against the outer periphery of the stent body 110, and the body open end 301 abuts against the outer periphery of the anchor frame 210, so that the abutting part 215 is a single-layer structure.

The axially disposed opening structure enables further reduction of the material of the valve stent, and the material of the skirt covering the valve stent, without affecting the function of the anchoring frame 210 or the stent body 110, and facilitates the grasping and releasing of the valve prosthesis.

Example 4

The present embodiment provides a heart valve prosthesis, which is an improvement on the heart valve prosthesis of embodiment 1, embodiment 2 or embodiment 3, wherein the outflow section of the anchoring frame 210 is configured with a notch structure 216, see fig. 16. The notch structure 216 is disposed toward the outflow channel side.

The notch structure 216 prevents the anchoring frame from crossing the ventricular wall surface, so that the artificial heart valve does not prevent the ventricular wall from excessively abutting against the right side of the aortic valve or the left side of the pulmonary valve, and the influence of the artificial heart valve body on the heart function can be reduced.

The notch structure 216 reduces the sub-valvular height of the outflow section 213, thereby reducing the risk of obstruction of the outflow tract. The shape and area of the notch structure 216 should be configured according to clinical needs, and is not intended to limit the scope of the present invention.

The above disclosure is only illustrative of the preferred embodiments of the present invention. The preferred embodiments are not intended to be exhaustive or to limit the invention to the precise embodiments disclosed. Obviously, many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, to thereby enable others skilled in the art to best utilize the invention. The present invention is limited only by the claims and their full scope and equivalents.

Claims (10)

1. A prosthetic heart valve, comprising a stent body for supporting a prosthetic leaflet, and an anchoring frame for anchoring the stent body at an annulus; the anchoring frame is arranged at a predetermined position close to the outflow channel side, the stent main body is arranged at a predetermined position outside the anchoring frame and away from the outflow channel side, and the anchoring frame abuts against and is connected with the stent main body.

2. The prosthetic heart valve of claim 1, wherein a peripheral side of the anchor frame and a peripheral side of the stent body abut one another and are connected at the abutment.

3. The prosthetic heart valve of claim 1 or 2, wherein the abutment of the anchoring frame and the stent body is a single layer structure.

4. The prosthetic heart valve of claim 3, wherein the anchor frame or the stent body is a non-occluding structure.

5. The prosthetic heart valve of claim 4, wherein the anchoring frame is axially an open structure, the open end of the anchoring frame being coupled to the stent body; or the bracket main body is of an opening structure along the axial direction, and the opening end of the bracket main body is connected with the anchoring frame.

6. The prosthetic heart valve of claim 3, wherein at the abutment, a portion of the anchoring frame is in an open configuration, a portion of the stent body abutting thereon is in a non-open configuration, while other portions of the anchoring frame are in a non-open configuration, and a portion of the stent body abutting thereon is in an open configuration.

7. The prosthetic heart valve of claims 1, 2, 4, 5, or 6, wherein the anchoring frame has a notch structure located at the outflow section of the anchoring frame, the notch structure configured to be oriented in the direction of the outflow tract.

8. The prosthetic heart valve of claim 1, further comprising at least one attachment ear through which the heart valve is attached to a delivery system; the connecting lug is arranged on the bracket main body or on the anchoring frame.

9. The prosthetic heart valve of claim 1, wherein the valve comprises a prosthetic leaflet disposed in the body portion.

10. The prosthetic heart valve of claim 1, wherein the anchor frame or the stent body is further provided with a skirt for sealing.

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