CN219423053U

CN219423053U - Artificial heart valve prosthesis

Info

Publication number: CN219423053U
Application number: CN202320795102.1U
Authority: CN
Inventors: 金亮; 刘世红; 陈国明
Original assignee: Shanghai Microport Cardioflow Medtech Co Ltd
Current assignee: Shanghai Microport Cardioflow Medtech Co Ltd
Priority date: 2023-04-10
Filing date: 2023-04-10
Publication date: 2023-07-28
Anticipated expiration: 2033-04-10

Abstract

The utility model provides a prosthetic heart valve prosthesis having axially opposite inflow and outflow ends and comprising a stent assembly and at least two leaflets; the bracket assembly comprises a valve frame and a valve seat structure; at least two valve feet protruding towards the direction far away from the inflow end are formed on the valve frame, and the distance from the valve feet to the axis of the bracket assembly is reduced along the direction from the inflow end to the outflow end; the valve seat structure comprises a valve seat body and an inner lining body, wherein the inner lining body is positioned at the inner side of the valve seat body, the inner lining body comprises a first basal body, at least two extension rods which extend towards the direction far away from the inflow end are arranged on the first basal body, the extension rods are arranged in one-to-one correspondence with valve feet, and the extension rods are positioned at the outer sides of the valve feet; at least two valve leaves are arranged on the bracket assembly in a one-way openable way; the valve foot applies a pulling force to the extension rod through the valve leaflet such that the distance of the extension rod to the axis of the stent assembly decreases in the inflow end to outflow end direction. The artificial heart valve prosthesis can avoid scraping and rubbing cardiac muscle when in application.

Description

Artificial heart valve prosthesis

Technical Field

The utility model belongs to the technical field of medical appliances, and particularly relates to a prosthetic heart valve prosthesis.

Background

The heart valve is a gate of heart blood circulation, once stenosis or insufficiency occurs, the heart can be in insufficient power or failure, and symptoms such as chest distress, asthma, whole body edema, weakness, chest pain and the like appear, so that the heart valve is a hidden danger which endangers the life and the life quality of the old. With aging population and development of medical technology, heart valve disease (valvular heart disease, VHD) has become the third largest cardiovascular disease, severely jeopardizing human health.

Replacement of a native diseased valve with a prosthetic heart valve prosthesis by conventional surgery is one of the important means of treating heart valve disease. Among them, the aortic valve and the mitral valve are the two valve positions where the valve replacement demand is greatest. For mitral valve replacement, left ventricular posterior wall rupture is a rare complication both intra-and post-operative, and only few cases are reported at present. The left ventricle back wall rupture rescue success rate is low, and the life of a patient is greatly threatened. The prosthetic heart valve prosthesis has too long valve feet, scratching the left ventricular posterior wall is one cause of left ventricular posterior wall rupture.

Disclosure of Invention

The utility model aims to provide a prosthetic heart valve prosthesis, which aims to reduce the condition that the prosthetic heart valve prosthesis scratches the rear wall of a left ventricle.

To achieve the above object, the present utility model provides a prosthetic heart valve prosthesis having axially opposite inflow and outflow ends and comprising a stent assembly and at least two leaflets; wherein,,

the bracket assembly comprises a valve frame and a valve seat structure; at least two valve feet protruding towards the direction far away from the inflow end are formed on the valve frame, and the distance from the valve feet to the axis of the bracket assembly gradually decreases along the direction from the inflow end to the outflow end; the valve seat structure comprises a valve seat body and an inner lining body, wherein the inner lining body is positioned at the inner side of the valve seat body and is connected with the valve seat body, the inner lining body comprises a ring-shaped first matrix, at least two extension rods which extend towards the direction far away from the inflow end are arranged on the first matrix, at least two extension rods are arranged in one-to-one correspondence with at least two valve feet, and the extension rods are positioned at the outer sides of the valve feet;

at least two valve blades are arranged on the bracket combination body in a one-way openable way;

the valve foot applies a pulling force to the extension rod through the valve leaflet so that the distance from the extension rod to the axis of the stent assembly gradually decreases in the direction from the inflow end to the outflow end.

Optionally, a first threading hole is formed in the extension rod; the valve seat body comprises an annular second base body, at least two clamping lugs protruding towards the direction away from the inflow end are arranged on the second base body, and the at least two clamping lugs are arranged in one-to-one correspondence with the at least two extension rods; the clamping lugs are provided with second threading holes which are aligned with the corresponding first threading holes on the extension rods;

a connecting wire passes through the second threading hole and the first threading hole and connects the inner lining body and the valve seat body.

Optionally, the length of the extension rod is greater than that of the clamping lug, and a third threading hole is further formed in the extension rod and is closer to the outflow end than the second threading hole;

the prosthetic heart valve prosthesis further comprises a skirt and a wrapping cloth, wherein the skirt wraps the valve frame, the wrapping cloth at least wraps the valve seat structure, and the wrapping cloth covers the third threading hole; the valve leaf is stitched with the skirt, a connecting line passes through the third threading hole, and connects the wrapping cloth with the skirt.

Optionally, the number of the valve feet is three, and the three valve feet are arranged at equal intervals along the circumferential direction of the bracket assembly.

Optionally, the leaflet includes a main body portion and two lugs respectively located at two circumferential sides of the main body portion, each lug penetrates through the leaflet foot and turns over to the outer side of the extension rod, and the lugs of two adjacent leaflets penetrating through the same leaflet foot are mutually sewed.

Optionally, the prosthetic heart valve prosthesis further comprises an annular sewing ring disposed outside of the valve seat body.

Optionally, the sewing ring has at least two protrusions formed thereon that protrude in a direction away from the inflow end.

Optionally, at least two of the protruding parts smoothly transition through a curved surface at the joint.

Optionally, the number of the protruding parts is two, the sewing ring is provided with an inner wall and an outer wall, the outer wall respectively forms a first low point and a second low point at two connecting positions where the two protruding parts are connected, and the projection of the protruding parts on a plane passing through the first low point and the second low point and parallel to the axis of the sewing ring is a curve.

Optionally, two of the protrusions are symmetrical about the plane.

Compared with the prior art, the artificial heart valve prosthesis has the following advantages:

the aforementioned prosthetic heart valve prosthesis has axially opposite inflow and outflow ends and comprises a stent assembly and at least two leaflets; wherein, the bracket assembly comprises a valve frame and a valve seat structure; at least two valve feet protruding towards the direction far away from the inflow end are formed on the valve frame, and the distance from the valve feet to the axis of the bracket assembly gradually decreases along the direction from the inflow end to the outflow end; the valve seat structure comprises a valve seat body and an inner lining body, wherein the inner lining body is positioned at the inner side of the valve seat body and is connected with the valve seat body; the inner lining body comprises a ring-shaped first substrate, at least two extension rods extending towards the direction far away from the inflow end are arranged on the first substrate, the at least two extension rods are arranged in one-to-one correspondence with the at least two petal legs, and the extension rods are positioned on the outer sides of the petal legs; at least two valve blades are arranged on the bracket combination body in a one-way openable way; the valve foot applies a pulling force to the extension rod through the valve leaflet so that the distance from the extension rod to the axis of the stent assembly gradually decreases in the direction from the inflow end to the outflow end. When the artificial heart valve prosthesis is implanted into a heart, the distance from the valve foot and the extension rod to the axis of the bracket assembly gradually decreases along the direction from the inflow end to the outflow end, so that the end parts of the valve foot and the extension rod, which are close to the outflow end, are practically adduction and far away from cardiac muscle, and the cardiac muscle can be effectively prevented from being scratched. Not only is the shape of the bracket assembly so that when the artificial heart valve prosthesis is implanted into a human body and decays to perform the valve operation in the valve, a new artificial valve prosthesis can be easily clamped into the artificial heart valve prosthesis and accurately positioned.

Drawings

The drawings are included to provide a better understanding of the utility model and are not to be construed as unduly limiting the utility model. Wherein:

FIG. 1 is a schematic illustration of a prosthetic heart valve prosthesis according to one embodiment of the present utility model, with the valve seat structure and partial wrapping being omitted to show the sewing ring;

FIG. 2 is a schematic illustration of a stent assembly of a prosthetic heart valve prosthesis according to one embodiment of the present utility model;

FIG. 3 is a partial cross-sectional view of a stent assembly of a prosthetic heart valve prosthesis provided in accordance with one embodiment of the present utility model;

FIG. 4 is a schematic view of the structure of a valve frame of a prosthetic heart valve prosthesis provided in accordance with an embodiment of the present utility model;

FIG. 5 is a top view of the valve frame of the prosthetic heart valve prosthesis shown in FIG. 4;

FIG. 6 is a schematic view of the structure of an inner liner of a prosthetic heart valve prosthesis provided in accordance with one embodiment of the present utility model;

FIG. 7 is a schematic plan view of the inner liner of the prosthetic heart valve prosthesis shown in FIG. 6;

FIG. 8 is a schematic view of the valve seat of a prosthetic heart valve prosthesis according to one embodiment of the present utility model;

FIG. 9 is a schematic plan view of the valve seat of the prosthetic heart valve prosthesis shown in FIG. 8;

FIG. 10 is a schematic view of the structure of a leaflet of a prosthetic heart valve prosthesis provided in accordance with an embodiment of the present utility model;

FIG. 11 is a partial schematic view of a prosthetic heart valve prosthesis according to one embodiment of the present utility model, showing the lugs of the leaflets passing through the valve foot and folded over to the outside of the extension stem, with the wrapping removed to show the extension stem;

FIG. 12 is a partial schematic view of a prosthetic heart valve prosthesis according to one embodiment of the present utility model, showing the lugs of the leaflets passing through the valve foot and folded over to the outside of the extension rod, with the wrapping removed to show the extension rod, and with FIG. 12 being a different viewing orientation than FIG. 11;

FIG. 13 is a schematic view of the suturing ring of a prosthetic heart valve prosthesis provided in accordance with one embodiment of the present utility model;

fig. 14 is a schematic view of a projection of a sewing ring of the prosthetic heart valve prosthesis shown in fig. 13.

Reference numerals are described as follows:

100-prosthetic heart valve prosthesis, 1000-stent assembly, 1100-valve frame, 1101-first circle, 1102-second circle, 1110-valve foot, 1200-valve seat structure, 1210-valve seat body, 1211-second base, 1212-clip, 1213-second threading hole, 1220-inner liner, 1221-first base, 1222-extension rod, 1223-first threading hole, 1224-third threading hole, 2000-valve leaflet, 2100-main body, 2200-lug, 3000-skirt, 4000-wrapping cloth, 5000-sewing ring, 5100-protrusion, 5200-hollowed hole.

Detailed Description

Other advantages and effects of the present utility model will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present utility model with reference to specific examples. The utility model may be practiced or carried out in other embodiments that depart from the specific details, and the details of the present description may be modified or varied from the spirit and scope of the present utility model. It should be noted that, the illustrations provided in the present embodiment merely illustrate the basic concept of the present utility model by way of illustration, and only the components related to the present utility model are shown in the drawings and are not drawn according to the number, shape and size of the components in actual implementation, and the form, number and proportion of the components in actual implementation may be arbitrarily changed, and the layout of the components may be more complex.

In addition, each embodiment of the following description has one or more features, respectively, which does not mean that the inventor must implement all features of any embodiment at the same time, or that only some or all of the features of different embodiments can be implemented separately. In other words, those skilled in the art can implement some or all of the features of any one embodiment or a combination of some or all of the features of multiple embodiments selectively, depending on the design specifications or implementation requirements, thereby increasing the flexibility of the implementation of the utility model where implemented as possible.

As used in this specification, the singular forms "a", "an" and "the" include plural referents, unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "connected" are to be construed broadly, as for example, they may be fixed, they may be removable, or they may be integrally connected. Either mechanically or electrically. Can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. The specific meaning of the above terms in the present utility model can be understood by those of ordinary skill in the art according to the specific circumstances.

The utility model will be further described in detail with reference to the accompanying drawings, in order to make the objects, advantages and features of the utility model more apparent. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the utility model. The same or similar reference numbers in the drawings refer to the same or similar parts.

The present utility model aims to provide a prosthetic heart valve prosthesis 100 as shown in fig. 1. The prosthetic heart valve prosthesis 100 has axially opposite inflow and outflow ends and includes a stent assembly 1000 and at least two leaflets 2000. The structure of the stent assembly 1000 is shown in fig. 2, and referring to fig. 2 in combination with fig. 3 to 7, the stent assembly 1000 includes a valve frame 1100 and a valve seat structure 1200. At least two petals 1110 are formed on the petal holder 1100 to project away from the inflow end. The distance from the petal 1110 to the axis of the stent assembly 1000 decreases progressively in the direction from the inflow end to the outflow end such that the petal 1110 forms an angle α (as shown in fig. 3) with the axis of the stent assembly 1000. The valve seat structure 1200 includes a valve seat body 1210 and an inner liner 1220, the inner liner 1220 is located at an inner side of the valve seat body 1210 and is connected with the valve seat body 1210, the inner liner 1220 includes a ring-shaped first base 1221, at least two extension rods 1222 extending in a direction away from the inflow end are disposed on the first base 1221, at least two extension rods 1222 are disposed in one-to-one correspondence with at least two valve feet 1110, and the extension rods 1222 are located at an outer side of the valve feet 1110. At least two of the leaflets 2000 are unidirectionally openable disposed on the stent assembly 1000. The foot 1110 applies a pulling force to the extension rod 1222 through the leaflet 2000 such that the distance of the extension rod 1222 from the axis of the stent assembly 1000 decreases gradually in the direction from the inflow end to the outflow end. The arrangement is such that at least two of the petals 1110 are on a conical surface and at least two of the extension bars 1222 are also on a conical surface, i.e., the ends of the petals 1110 near the outflow end and the ends of the extension bars 1222 near the outflow end are adducted. Thus, when the prosthetic heart valve prosthesis is implanted in the heart, the valve foot 1110 and the extension rod 1222 are far away from the heart muscle, and do not scratch the heart muscle during the contraction and relaxation of the heart muscle to cause damage to the heart muscle. Not only is the prosthetic heart valve prosthesis more easily stuck inside the decayed prosthetic heart valve prosthesis and more precisely positioned, because the entire prosthetic heart valve prosthesis assumes a tapered configuration when the prosthetic heart valve prosthesis is decayed in the human body and a new valve prosthesis needs to be re-implanted.

The prosthetic heart valve prosthesis 100 may be used as an aortic valve prosthesis, a mitral valve prosthesis, or a tricuspid valve prosthesis, and when used as a mitral valve prosthesis, the valve foot 1110 and the extension rod 1222 do not scratch the back wall of the left ventricle, thereby avoiding the rupture of the back wall of the left ventricle. The axial direction of the prosthetic heart valve prosthesis 100 as referred to herein refers to a direction parallel to the flow direction of blood after the prosthetic heart valve prosthesis 100 is implanted in a human body. After the prosthetic heart valve prosthesis 100 is implanted in the heart, blood flows into the prosthetic heart valve prosthesis 100 from the inflow end and flows out of the prosthetic heart valve prosthesis 100 from the outflow end.

The valve frame 1100 provides an attachment frame for the valve leaflet 2000, and the connection relationship of the valve leaflet 2000 and the valve frame 1100 will be described in detail later.

Fig. 4 shows a schematic structural view of the valve frame 1100. The valve frame 1100 actually includes at least two peaks and at least two valleys alternately arranged in the circumferential direction of the stent assembly 1000, the size of each of the peaks is smaller than the size of each of the valleys in the circumferential direction of the stent assembly 1000, and each of the peaks constitutes one of the valve feet 1110. The number of the petals 1110 may be three, and preferably three of the petals 1110 are equally spaced in the circumferential direction of the petal holder 1100, in other words, adjacent two of the petals 1110 are spaced apart by an angle of 120 ° (as shown in fig. 5). Accordingly, the number of the leaflets 2000 is three, and each of the leaflets 2000 is provided on two adjacent leaflets 1110, and the number of the extension bars 1222 is also three. Preferably, the ends of all the petals 1110 near the outflow end are located on the same first circle 1101, and the bottoms of all the valleys are located on a second circle 1102, the second circle 1102 being arranged coaxially with the first circle 1101. The valley bottom means a point farthest from the outflow end in the axial direction of the stent assembly 1000.

In an embodiment of the present utility model, the valve frame 1100 is made of a highly elastic material, and an alternative material is nickel-titanium alloy, for example. After the artificial heart valve prosthesis 100 is implanted into the heart, the valve frame 1100 with high elasticity can forcefully open the diseased (calcified for example) native valve leaflet to ensure the anchoring stability of the artificial heart valve prosthesis 100, and on the other hand, the valve foot 1110 can have better contractility and restorability, so as to adapt to the opening and closing of the valve leaflet 2000.

Fig. 8 shows a schematic structural view of the valve seat body 1210, and fig. 9 shows a schematic plan-view development of the valve seat body 1210. Referring to fig. 8 and 9 in combination with fig. 2, the valve seat body 1210 includes a ring-shaped second base 1211, at least two lugs 1212 protruding in a direction away from the inflow end are disposed on the second base 1211, and the at least two lugs 1212 are disposed in one-to-one correspondence with the at least two extension rods 1222. In the axial direction of the bracket assembly 1000, the length of the grip ear 1212 is less than the length of the extension rod 1222. The extension rod 1222 is provided with a first threading hole 1223, the grip 1212 is provided with a second threading hole 1213, and the second threading hole 1213 is aligned with the first threading hole 1223 of the extension rod 1222. In this way, the flap seat 1210 and the inner liner 1220 may be connected by a connection line passing through the first and second string holes 1223 and 1213. When the number of the valve feet 1110 is three, the number of the clamping ears 1212 is also three.

In the embodiment of the present utility model, the valve seat body 1210 is made of a metal material, and the inner liner 1220 is made of plastic. The valve seat 1210 made of metal can provide greater rigidity to cope with the contraction and extrusion of the native valve annulus of the human body, so as to avoid deformation of the valve frame 1100. The inner liner 1220 made of plastic isolates the valve seat 1210 from the valve frame 1100, preventing the valve seat 1210 and the valve frame 1100 from corroding each other.

In practice, the prosthetic heart valve prosthesis 100 further comprises a skirt 3000 and a wrap 4000. Wherein the skirt 3000 wraps around the valve frame 1100 and is attached to the valve frame 1100, and the leaflet 2000 is sewn to the skirt 3000, that is, the leaflet 2000 is connected to the valve frame 1100 through the skirt 3000. The wrapping cloth 4000 wraps the valve seat structure 2000. Further, a third threading hole 1224 is further provided on the extension rod 1222, and the third threading hole 1224 is closer to the outflow end than the second threading hole 1223. The wrapping cloth 4000 is sewn to the valve seat structure 2000 by a connecting line passing through the third threading hole 1224, and further connects the wrapping cloth 4000 and the skirt 3000. Thus, the above-mentioned "the leaflet 1110 applies a pulling force to the extension rod 1222 through the leaflet 2000" means that the leaflet 1110 transmits a pulling force to the skirt 3000 and the wrapping cloth 4000 through the leaflet 2000, and thus to the extension rod 1222.

Further, as shown in fig. 10, the leaflet 2000 includes a main body 2100 and two lugs 2200 respectively located at both circumferential sides of the main body 2100. As shown in fig. 11 and 12, each of the lugs 2200 passes through one of the flaps 1100 and is folded to the outside of the extension 1222 that wraps the wrapping cloth 4000. It should be appreciated that since the stent assembly 1000 is entirely wrapped by the wrapping cloth 4000, the extension rod 1222 is isolated from the lug 2200 of the leaflet 2000 by the wrapping cloth 4000. The lugs 2200 of adjacent two of the leaflets 2000 passing through the same leaflet 1100 are sewn to each other so that the adjacent two of the leaflets 2000 are connected together. As used herein, "two lugs 2200 on both circumferential sides of the body portion 2100" means that when the leaflet 2000 is assembled to the stent assembly 1000, two lugs 2200 of one leaflet 2000 are located on both opposite sides of the body portion 2100 as seen in the circumferential direction of the stent assembly 1000.

Further, referring back to fig. 1, the prosthetic heart valve prosthesis 100 further includes a sewing ring 5000. The sewing ring 5000 has a ring-shaped structure and is disposed outside the flap holder 1210 wrapped with the wrapping cloth 4000. It should be appreciated that since the stent assembly 1000 is entirely wrapped by the wrapping cloth 4000, the flap seat 1210 is isolated from the sewing ring 5000 by the wrapping cloth 4000. Further, the wrapping cloth 4000 also wraps around the sewing ring 5000, and thus, in the fully assembled prosthetic heart valve prosthesis 100, the sewing ring 5000 is not visible due to being hidden by the wrapping cloth 4000.

Those skilled in the art will appreciate that the sewing ring 5000 is used to sew with the native annulus of a patient. In order to make the sewing ring 5000 better fit the irregular shape of the outer contour of the native valve annulus, reduce the pulling of the native valve annulus during sewing, reduce the damage to the native tissue, and also ensure that the sewing ring 5000 can adapt to the native valve annulus with different forms, and improve the universality of the sewing ring 5000, the embodiment of the utility model designs the end surface of the sewing ring 5000 near the exposed outflow end to have at least two protruding parts 5100 protruding towards the direction far away from the inflow end by simulating the outer contour of the native valve annulus (as shown in fig. 13), and the at least two protruding parts 5100 are connected end to form a closed annular structure.

Alternatively, the number of the protrusions 5100 is two. The sewing ring 5000 has an inner wall and an outer wall, the outer wall forms a first low point a and a second low point P at two junctions of the two protruding portions 5100, respectively, and the first low point a and the second low point P are disposed opposite to each other in a circumferential direction of the sewing ring 5000. Taking the mitral valve as an example, the first low point a is used for matching the highest point of the anterior leaflet of the native mitral valve, and the second low point P is used for matching the highest point of the posterior leaflet of the native mitral valve, that is, after the prosthetic valve prosthesis is implanted, the position of the first low point a of the sewing ring 5000 is aligned with the position of the highest point of the anterior leaflet of the native mitral valve, and the position of the second low point P is aligned with the position of the highest point of the posterior leaflet of the native mitral valve, so as to improve the fit between the sewing ring 5000 and the native mitral valve.

Further, the protrusion 5100 has a highest point PM, and the axial height of the protrusion 5100 gradually decreases from the highest point PM to the first low point a and the second low point P, respectively, toward both sides. That is, the axial height of the side of the protrusion 5100 near the first low point a gradually decreases from the highest point PM to the first low point a, and the axial height of the side of the protrusion 5100 near the second low point P gradually decreases from the highest point PM to the second low point P, so that the gradual manner matches with the shape of the outer contour of the native valve annulus, the pulling of the native valve annulus tissue of the human mitral valve in the suturing process is further reduced, the damage to the native tissue is reduced, and meanwhile, the adaptability of the suturing ring 5000 is improved, so that the suturing ring 5000 can adapt to the native valve annulus with different shapes, more group requirements are satisfied, and further, after the suturing ring 5000 is implanted into a patient, a better surgical effect can be achieved.

Referring to fig. 14, fig. 14 is a projection of the outer wall of the sewing ring 5000 on a plane passing through the first low point a and the second low point P and parallel to the axial direction of the sewing ring 5000. In which the straight line AP is a line connecting the first low point a and the second low point P, as can be seen from fig. 14, the projection 5100 of the projection on a plane passing through the first low point a and the second low point P and parallel to the axis of the sewing ring 5000 is a smooth curve. By configuring the projection of the projection 5100 of the sewing ring 5000 on a plane passing through the first low point a and the second low point P and parallel to the axial direction of the sewing ring 5000 as a smooth curve, the external contour of the native valve ring can be better matched, so that the sewing ring 5000 can better fit with the native tissue after being implanted into the patient, thereby achieving better surgical effect and improving prognosis.

With continued reference to fig. 14, specifically, the curve obtained by the projection is configured such that an included angle a between the tangent line at the first low point a and the straight line AP ranges from 45 ° to 75 °; the included angle b between the tangent line of the curve at the second low point P and the straight line AP ranges from 7 degrees to 13 degrees. The vertical distance H from the highest point PM of the projection 5100 to the straight line AP is 1.5mm-6mm. By means of the size design, the sewing ring 5000 can better fit the outer contour of the primary valve ring, the pulling of the primary valve ring tissue of a human body in a sewing process is reduced, and the damage to the primary tissue is reduced.

Further, two protrusions 5100 are located at two sides of the connection line between the first low point a and the second low point P. Preferably, the two protrusions 5100 are symmetrical about a plane, wherein the symmetry plane is a plane passing through the first low point a and the second low point P and parallel to the axial direction of the sewing ring 5000, and the two protrusions 5100 are symmetrically arranged, so that the sewing ring 5000 better matches the two-side symmetrical three-dimensional curve profile of the outer profile of the native valve ring.

Preferably, the two protruding parts 5100 are smoothly transited through a curved surface at the connection part, more preferably, the two protruding parts 5100 are tangentially connected at the first low point a and tangentially connected at the second low point P, so that a sharp corner structure is prevented from being formed at the connection part of the two protruding parts 5100, and the outer contour of the native valve annulus is better fitted, and thus better operation effect is achieved.

Further, referring back to fig. 13, the sewing ring 5000 is provided with a hollowed hole 5200 extending along the axial direction of the sewing ring 5000 between the inner wall and the outer wall. By arranging the hollowed-out hole 5200 between the inner wall and the outer wall of the sewing ring 5000, the flexibility of the sewing ring 5000 can be effectively improved, so that the sewing ring 5000 is easier to attach to the native valve ring and can be changed along with the cardiac cycle without tearing.

The assembly process of the prosthetic heart valve prosthesis is similar to the prior art.

All components of the prosthetic heart valve prosthesis can be divided into an upper part comprising the valve frame 1100, the skirt 3000, and the leaflet 2000, and a lower part comprising the wrap 4000 and the valve seat structure 1200. In assembly, the upper and lower parts of the prosthetic heart valve prosthesis are assembled separately, and then the upper part, lower part and sewing ring 5000 are assembled together.

The skirt 3000 is generally rectangular in configuration. When the upper part component is assembled, step S1 is executed first: the short sides of the skirt 3000 are folded in half into seam sides so that the skirt 3000 has an elongated structure, and then two opposite sides of the skirt 3000 are seamed to form a ring-shaped structure, and the flap frame 1100 is wrapped with the seam side using the ring-shaped skirt 3000. Subsequently, step S2 is performed: the leaflet 2000 is placed under the skirt 3000 and the valve frame 1100, and the leaflet 2000 is sutured to the skirt 3000.

When assembling the lower part, step S3 is first performed: the valve seat body 1210 is sleeved outside the inner liner 1220, and each of the first string holes 1223 is aligned with one of the second string holes 1213. The inner liner 1220 is then connected to the valve seat 1210 using a connection line passing through the first and second threaded holes 1223 and 1213. Step S4 is then performed: the flap seat structure 1200 is wrapped with the wrapping cloth 4000 and sewn. In the step S4, the size of the wrapping cloth 4000 is larger, and a portion remains after wrapping the valve seat structure 1200 for wrapping the sewing ring 5000 in the subsequent step.

Next, step S5 is performed: the upper part is placed inside the lower part and the free edges of all the leaflets 2000 are aligned, and then the skirt 3000 is sewn to the wrap 4000. Step S6 is then performed: the lugs 2200 of the leaflet 2000 are passed through the corresponding leaflet 1110 and folded over to the outside of the extension rod 1222 wrapped with the wrapping cloth 4000, and the lugs 2200 of two adjacent leaflets 2000 are sewn together. Finally, step S6 is performed: the sewing ring 5000 is sleeved on the outer side of the flap seat 1210 wrapped with the wrapping cloth 4000, and then the sewing ring 5000 is wrapped with the remaining portion of the wrapping cloth 4000 and is sewn.

Although the present utility model is disclosed above, it is not limited thereto. Various modifications and alterations of this utility model may be made by those skilled in the art without departing from the spirit and scope of this utility model. Thus, it is intended that the present utility model also include such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

1. A prosthetic heart valve prosthesis, wherein the prosthetic heart valve prosthesis has axially opposite inflow and outflow ends and comprises a stent assembly and at least two leaflets; wherein,,

2. The prosthetic heart valve prosthesis of claim 1, wherein the extension rod is provided with a first threaded aperture; the valve seat body comprises an annular second base body, at least two clamping lugs protruding towards the direction away from the inflow end are arranged on the second base body, and the at least two clamping lugs are arranged in one-to-one correspondence with the at least two extension rods; the clamping lugs are provided with second threading holes which are aligned with the corresponding first threading holes on the extension rods;

3. The prosthetic heart valve prosthesis of claim 2, wherein the extension rod has a length greater than the clip and a third threaded aperture disposed in the extension rod, the third threaded aperture being closer to the outflow end than the second threaded aperture;

4. The prosthetic heart valve prosthesis of any one of claims 1-3, wherein the number of valve feet is three, the three valve feet being equally spaced circumferentially of the stent assembly.

5. A prosthetic heart valve prosthesis according to any one of claims 1-3, wherein the leaflet comprises a main body portion and two lugs located on either side of the main body portion in the circumferential direction, each lug passing through the leaflet and turned over to the outside of the extension rod, the lugs of adjacent two leaflets passing through the same leaflet being sewn to each other.

6. The prosthetic heart valve prosthesis of any one of claims 1-3, further comprising an annular sewing ring disposed outside of the valve seat body.

7. The prosthetic heart valve prosthesis of claim 6, wherein the sewing ring has at least two protrusions formed thereon that protrude in a direction away from the inflow end.

8. The prosthetic heart valve prosthesis of claim 7, wherein at least two of the protrusions smoothly transition at the junction with a curved surface.

9. The prosthetic heart valve prosthesis of claim 7, wherein the number of projections is two, the sewing ring having an inner wall and an outer wall, the outer wall forming a first low point and a second low point at two junctions where the two projections meet, respectively, the projections being curved in projection on a plane passing through the first low point and the second low point and parallel to an axis of the sewing ring.

10. The prosthetic heart valve prosthesis of claim 9, wherein two of the projections are symmetrical about the plane.