CN117752469A - Heart valve prosthesis - Google Patents

Abstract

The present invention provides a heart valve prosthesis for replacing a native mitral or tricuspid valve. The heart valve prosthesis comprises a valve frame and a covering film; the valve frame includes an atrial segment and a ventricular segment, the atrial segment configured to extend radially outward relative to the ventricular segment; the cover includes a first portion encasing the atrial segment, the first portion of the cover being redundant at least on an underside of the atrial segment to form an inflatable balloon; the cover also defines an opening in communication with the inflatable bladder to supply blood to the inflatable bladder to inflate and expand the inflatable bladder. The heart valve prosthesis can significantly reduce paravalvular leakage and even avoid the occurrence of paravalvular leakage.

Description

Heart valve prosthesis

Technical Field

The invention relates to the field of medical instruments, in particular to a heart valve prosthesis.

Background

The human heart includes a right atrium and a right ventricle providing pulmonary circulation, and a left atrium and a left ventricle providing oxygenated blood received from the lungs to the rest of the body. The heart valve includes a tricuspid valve at the junction of the right atrium and the right ventricle, and a mitral valve at the junction of the left atrium and the left ventricle. The leaflets of the mitral or tricuspid valve open and close in response to changes in blood pressure caused by contraction and relaxation of the heart chambers, the leaflets opening up one another to allow blood flow from the atrium to the heart chamber through the valve, and the leaflets closing up one another to prevent regurgitation in a retrograde fashion.

Heart valve diseases include stenosis and regurgitation. Valve stenosis can impede the normal flow of blood to the downstream ventricle, resulting in the heart working harder to pump blood through the diseased valve. Regurgitation of blood from the ventricles to the atria occurs when the valve is not fully closed, resulting in reduced cardiac efficiency.

The heart valve prosthesis may be delivered by a delivery system to and deployed and positioned at the diseased valve to replace the native valve operation. Under the prior art, there is often a problem of paravalvular leakage after implantation of a heart valve prosthesis: because the heart valve prosthesis and the annular tissue cannot be completely attached and gaps exist, when the heart contracts, the pressure of blood in the ventricle rises to push at least two artificial valve leaflets which can be opened and closed relatively in the heart valve prosthesis to be mutually matched, but part of high-speed blood flow can be pumped out of the atrium around the heart valve prosthesis through the gaps, namely, paravalvular leakage occurs. Serious and prolonged paravalvular leaks can lead to heart failure or sudden death of the patient.

Disclosure of Invention

To solve the above technical problems, the present invention provides a heart valve prosthesis for replacing a diseased native mitral valve or tricuspid valve.

The heart valve prosthesis comprises a valve frame and a covering film; the valve frame includes an atrial segment and a ventricular segment, the atrial segment configured to extend radially outward relative to the ventricular segment; the cover includes a first portion encasing the atrial segment, the first portion of the cover being redundant at least on an underside of the atrial segment to form an inflatable balloon; the cover also defines an opening in communication with the inflatable bladder to supply blood to the inflatable bladder to inflate and expand the inflatable bladder.

The present invention provides a heart valve prosthesis, wherein the first portion of the covering membrane is arranged such that there is redundancy at least on the underside of the atrial section of the valve frame to form an inflatable balloon; when the heart valve prosthesis is implanted at the diseased native mitral or tricuspid valve, the atrial segment of the valve frame is in abutment or proximity to atrial side annulus tissue; when the ventricle contracts, the high-speed blood in the ventricle flows through the open mouth defined by the covering film to flush into the inflatable bag, so that the inflatable bag is filled and expanded, and the expanded inflatable bag can adaptively fill gaps between different parts of the atrial section and the annular tissue by utilizing the fluid characteristic of the blood flow, thereby remarkably reducing the paravalvular leakage and even avoiding the paravalvular leakage.

Drawings

FIG. 1 is a schematic perspective view of a first embodiment of a heart valve prosthesis of the present invention;

FIG. 2 is a schematic perspective view of the heart valve prosthesis of FIG. 1;

FIG. 3 is a schematic front view of the heart valve prosthesis of FIG. 1;

FIG. 4a is a schematic axial cross-section of the heart valve prosthesis of FIG. 1;

FIG. 4b is an enlarged schematic view at A in FIG. 4 a;

FIG. 5 is an axially cut-away schematic perspective view of the heart valve prosthesis of FIG. 1;

FIG. 6 is a perspective combined schematic view of the valve frame in the heart valve prosthesis of FIG. 1;

FIG. 7 is an exploded perspective view of the valve carriage of FIG. 6;

FIG. 8a is a schematic top view of the outer layer valve frame of FIG. 6;

FIG. 8b is a schematic front view of the outer layer valve frame of FIG. 6;

FIG. 8c is a schematic perspective view of the transition struts of FIG. 8b and the first and second struts of the atrial segment from a perspective;

FIG. 8d is a schematic perspective view of the transition struts of FIG. 8b and the first and second struts of the atrial segment from another perspective;

FIG. 9a is a schematic view of blood rushing into the inflatable bladder of the heart valve prosthesis of FIG. 1;

FIG. 9b is a schematic view of the heart valve prosthesis of FIG. 9a implanted in a native heart valve;

FIG. 10a is a schematic axial cross-section of a second embodiment of a heart valve prosthesis of the present invention;

FIG. 10B is an enlarged schematic view at B in FIG. 10 a;

FIG. 11 shows an enlarged schematic view of an inflatable balloon in a third embodiment of a heart valve prosthesis of the present invention;

FIG. 12 is a schematic view of a fourth embodiment of a heart valve prosthesis of the present invention;

fig. 13 is a schematic view of a fifth embodiment of the heart valve prosthesis of the present invention.

Detailed Description

For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments of the present invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention. In addition, as long as there is no conflict or conflict between the embodiments described below, the same or similar concepts, structures or processes may not be described in detail in some embodiments.

It is first noted that, in this context, the "upper end/upper side", "lower end/lower side" of the heart valve prosthesis and its components are defined according to the position of the heart valve prosthesis within the heart, wherein "upper end/upper side" refers to the end or side that is proximal to the atrial side; "lower end/side" refers to the end or side that is proximal to the ventricular side. With the direction from the ventricle to the atrium being the "up" direction and the direction from the atrium to the ventricle being the "down" direction. "axial" refers to a direction parallel to the central axis of the heart valve prosthesis. "radial" refers to a direction perpendicular or substantially perpendicular to the axial direction, the diameter or radius of the component. "circumferential" refers to a direction about the axial direction. It should be noted that the above terms indicating orientation or positional relationship are merely for convenience of description and simplification of the description, and are not intended to indicate or imply that the apparatus or elements in question must have a specific orientation, be constructed and operate in a specific orientation, and therefore should not be construed as limiting the invention.

The heart valve prosthesis of the present invention is suitable for replacing a diseased native mitral valve or tricuspid valve. The heart valve prosthesis has a compressed configuration for delivery within the vasculature of a patient and an expanded configuration for deployment within the native mitral or tricuspid valve of the patient. The description of the various embodiments is based on the construction of the heart valve prosthesis in the expanded configuration, unless otherwise specified.

Referring to fig. 1 to 2, a heart valve prosthesis 100 according to a first embodiment of the present invention includes a valve frame 10, leaflets 30 fixedly provided in the valve frame 10, and a coating film 50 coated on the valve frame 10. Wherein the valve frame 10 is capable of self-expanding or self-rotating from its compressed configuration to its expanded configuration. The valve frame 10 is formed of an elastic or shape memory material such as a nitinol (e.g., nitinol) that has a shape memory function to self-restore to an expanded configuration. In some embodiments, the valve frame 10 can be made using laser cutting of tubing of shape memory material and subsequent heat setting, etc. The leaflets 30 can be attached to the interior of the valve frame 10 by suturing or the like in a fixed manner for controlling blood flow through the heart valve prosthesis 100. The number of leaflets 30 can be two, three or more, allowing blood to flow downwardly when the leaflets are separated from each other and preventing blood from flowing upwardly when the leaflets are mutually coaptated. The leaflet 30 may be made of porcine pericardium, bovine pericardium, or high molecular polymer materials such as polyester, ultra high molecular weight polyethylene materials, etc. The cover 50 serves to prevent blood leakage, particularly paravalvular leakage, between the implanted heart valve prosthesis 100 and native heart tissue, and in addition, the cover 50 can also provide a medium for tissue ingrowth, accelerating the endothelialization process. The material of the cover film 50 may be polyester, polytetrafluoroethylene woven fabric, or the like, and is preferably woven fabric having a small permeability such as polyethylene terephthalate (Polyethylene terephthalate, PET) polyester cloth or PET terry cloth.

Referring to fig. 1, 4a, 6 and 9b, the valve frame 10 includes an atrial segment 11, a transition segment 13 and a ventricular segment 15, which correspond to the dimensional divisions of different locations within the native heart after implantation of the heart valve prosthesis 100. As the name suggests, after replacement of the native heart valve by the heart valve prosthesis 100, the atrial segment 11 is on the atrial side, the ventricular segment 15 is on the ventricular side, and the transition segment 13 extends from the ventricular side across the annulus to the atrial side.

Referring to fig. 1, 2, 4a, and 5-7, the valve frame 10 includes an outer layer valve frame 12 and an inner layer valve frame 14 of split design, divided from the constructional dimensions of the heart valve prosthesis 100, wherein the inner layer valve frame 14 is connected radially inward of the outer layer valve frame 12, and a radial gap exists between the outer layer valve frame 12 and the inner layer valve frame 14. The inner petal rack 14 has a substantially hollow cylindrical shape and has a mesh structure formed by sequentially connecting a plurality of layers of wave rods (not shown) in the axial direction. The leaflets 30 are sutured in the inner layer valve frame 14 with radial support performance, and the inner layer valve frame 14 can effectively resist the extrusion of the outer layer valve frame 12 to the leaflets 30, so that the opening and closing states of the leaflets 30 are affected to a small extent.

Wherein the inner layer valve frame 14 may all correspond to the ventricular segment 15, or a partial section of the inner layer valve frame 14 corresponds to the ventricular segment 15, the remaining section corresponds to the transition segment 13, or even more preferably, a partial section of the inner layer valve frame 14 corresponds to the ventricular segment 15, a partial section corresponds to the transition segment 13, and the remaining section corresponds to the atrial segment 11, such arrangement may raise the height of the leaflet 30, help reduce the overall axial height of the valve frame 10, shorten the height occupied by the valve frame 10 within the ventricle, and reduce the risk of blocking the left ventricular outflow tract.

The outer valve frame 12 is corresponding to the atrial segment 11, the transition segment 13 and the ventricular segment 15. The corresponding atrial segment 11 of the outer layer valve frame 12 is configured to extend radially outwardly relative to the ventricular segment 15, further in connection with fig. 8a and 8b, said atrial segment 11 being formed of a plurality of struts distributed circumferentially into a substantially disc-like or flange-like multi-lattice configuration. The ventricular segment 15 has a cylindrical mesh structure formed by sequentially connecting at least two layers of waved rods (not shown) in the axial direction.

Referring to fig. 1 to 5, the covering film 50 includes a first portion 51 covering the corresponding atrial segment 11 of the outer layer valve frame 12, a second portion 53 connecting the first portion 51 and covering the corresponding transition section 13 and ventricular segment 15 of the outer layer valve frame 12, and a third portion 55 connecting the first portion 51 and covering the inner layer valve frame 14, wherein a radial gap exists between the second portion 53 and the third portion 55.

It should be noted in particular that the first portion 51 of the cover 50 presents redundancy at least on the underside of the atrial segment 11 (lower redundancy for short) to form an inflatable balloon 511; the second portion 53 and the third portion 55 of the cover 50 define an opening 57 therebetween that communicates with the inflatable bladder 511. The underside redundancy can be understood as follows: instead of being in a flattened form against the underside of the atrial segment 11, the first portion 51 of the cover 50 may have a redundant membrane that may be loosely applied to the underside of the atrial segment 11, or the membrane of the first portion 51 of the cover 50 may have a larger area of expansion on the underside of the atrial segment 11 than on the envelope of the underside of the atrial segment 11, and the inflatable bladder 511 may bulge or protrude downwardly relative to the atrial segment 11 after the inflatable bladder 511 is inflated with fluid, and the degree of bulge or protrusion may be controlled by the degree of fluid filling.

With reference to fig. 9a and 9b, after implantation of the heart valve prosthesis 100 in a patient's heart, replacement of a diseased native mitral or tricuspid valve, the atrial segment 11 is placed against or adjacent to the atrial side annular tissue, the opening 57 is on the ventricular side, and the opening 57 is open downward. During ventricular systole, high velocity blood within the ventricle passes through the open port 57, into the inflatable bladder 511 in a path that is the radial gap between the second portion 53 and third portion 55 of the cover 50, causing the inflatable bladder 511 to inflate and expand. The inflated inflatable bladder 511 is capable of adaptively filling the gaps between the atrial segment 11 and the different portions of the annulus tissue with the fluid properties of the blood flow, blocking the backflow of blood flow from around the heart valve prosthesis 100 to the atrium, thereby enabling a significant reduction in paravalvular leakage and even avoiding the occurrence of paravalvular leakage. In this process, since the opening 57 is located in the ventricular side with the opening 57 facing downward, the opening 57 is not obstructed by heart tissue and the heart valve prosthesis 100, but is also near the highest pressure region of blood flow, thereby facilitating a momentary large upward flush of blood flow into the inflatable bladder 511.

As shown in fig. 2 and fig. 4a to fig. 5, in the present embodiment, it is preferable that the second portion 53 of the cover film 50 covers the outer surface (i.e. the radially outer surface) of the outer layer valve frame 12 corresponding to the transition section 13 and the ventricular section 15, and the third portion 55 of the cover film 50 covers the inner surface (i.e. the radially inner surface) of the inner layer valve frame 14, so that the radial gap between the second portion 53 and the third portion 55 is maximized, thereby maximizing the size of the opening 57 and the blood flow injecting path, and facilitating the blood flow injecting. More preferably, the opening 57 extends circumferentially through and around the third portion 55 of the membrane 50 to allow for a more uniform circumferential filling of the various regions of the inflatable bladder 511.

It will be appreciated that in other embodiments, the second portion 53 of the cover 50 may also overlie the inner surface (i.e., radially inner surface) of the outer layer valve frame 12 corresponding to the transition segment 13 and the ventricular segment 15; the third portion 55 of the cover 50 may also overlie the outer (i.e., radially outer) surface or/and the inner surface of the inner valve frame 14; the openings 57 may be distributed locally or at intervals in the circumferential direction; the opening 57 may be arranged concentrically or eccentrically with the third portion 55 of the cover film 50; the present invention is not particularly limited as long as it is satisfied that a radial gap is provided between the second portion 53 and the third portion 55 of the covering film 50, the radial gap communicates the opening 57 and the inflatable bladder 511, and the upper end of the second portion 53 and the upper end of the third portion 55 are respectively connected with both ends of the first portion 51 in a sealing manner.

As shown in fig. 4a to 5, 9a and 9b, in the present embodiment, the first portion 51 of the covering film 50 also has redundancy (upper redundancy for short) on the upper side of the atrial segment 11, and the upper redundancy can be understood as follows: the first portion 51 of the covering film 50 is not attached to the upper side of the atrial section 11 in a flattened form, but has an excess film body which can be loosely covered on the upper side of the atrial section 11, or the film body of the first portion 51 of the covering film 50 on the upper side of the atrial section 11 has a larger expansion area than the area of the envelope surface on the upper side of the atrial section 11; the inflatable bladder 511 is formed by the upper redundancy and the lower redundancy being co-enclosed, and the inflatable bladder 511 is capable of bulging or protruding upwardly relative to the atrial segment 11 when fluid is flushed into the inflatable bladder 511. Increasing the superior redundancy can increase the volume of the inflatable bladder 511, as compared to the case where only the inferior redundancy is deployed to form the inflatable bladder 511, on the one hand increasing blood volume to more tightly pack the gaps between the atrial segment 11 and the different portions of the annulus tissue; on the other hand, can provide a larger flow space for blood flow in the inflatable bag 511, so that the fluidity is improved, and the generation of thrombus is reduced; in yet another aspect, if there is a loss of blood in the inflatable bladder 511 corresponding to the lower redundant site, blood in the inflatable bladder 511 corresponding to the upper redundant site will immediately replenish the lower redundant site so that the inflatable bladder 511 remains tamponade of the gap between the atrial segment 11 and the annulus tissue.

As shown in fig. 6 to 8b, the atrial segment 11 includes a plurality of struts distributed in a circumferential direction, and in particular, in this embodiment, the atrial segment 11 includes a plurality of cells 123 distributed in a circumferential direction, each cell 123 includes a first strut 1231 and a second strut 1233, the lower ends of the first strut 1231 and the second strut 1233 are circumferentially spaced apart from each other, and the upper ends of the first strut 1231 and the second strut 1233 are connected to each other and smoothly transition, and each cell 123 exhibits a shape, such as a similar shape to a triangle, a sine curve, or the like, without limitation. It will be appreciated that the struts may take other forms, such as, but not limited to, the struts being spaced apart from one another, being radially spaced apart in the circumferential direction, and the like. Struts of the atrial segment 11 are located inside the inflatable balloon 511, forming an internal skeleton of the inflatable balloon 511, which on the one hand promotes rigidity to help maintain a seal between the inflatable balloon 511 and the atrial side annulus tissue; on the other hand, the struts of the atrial segment 11 are capable of bringing the first portion 51 of the membrane 50 to follow the atrial segment 11 to be compressed or expanded; the struts of the atrial segment 11 in a further aspect also serve to prevent the entire heart valve prosthesis 100 from moving to the ventricular side under the impact of blood flow during diastole.

Referring to fig. 1, 4a, 4b and 9a, in the present embodiment, the first portion 51 of the covering film 50 is freely covered on the plurality of struts of the atrial segment 11, i.e. the film body of the first portion 51 has no connection point or fixing point with each strut, so that all the positions of the inflatable bag 511 are communicated, and the inflated inflatable bag 511 forms a complete circle of bulge or protrusion, so that the gaps between the atrial segment 11 and the valve annulus tissue can be adaptively filled over a complete circle by utilizing the fluid characteristics of the blood flow. Specifically, the membrane body of the first portion 51 of the covering membrane 50 may be one-piece or monolithic, one end of the membrane body may be sewn to an upper end of the third portion 55 sewn to the inner flap frame 14, and the other end of the membrane body of the first portion 51 may be sewn to the second portion 53 sewn to the outer flap frame 12 corresponding to the transition section 13 and the ventricular section 15. The first portion 51 of the cover 50, except for the two ends for connection, then extends freely along the upper sides of the struts of the atrial segment 11, then folds freely over to the lower sides of the struts of the atrial segment 11 and continues to extend freely.

It will be appreciated that in other embodiments, the first portion 51 of the cover 50 may be joined together by stitching from two sheets of film at locations corresponding to the folds described above.

It will be appreciated that in other embodiments, the first portion 51 of the cover 50 may be attached to at least one strut of the atrial segment 11 at least one or a plurality of spaced apart locations, for example, to the junction, i.e., the upper end, of each of the first and second struts 1231, 1233, thereby forming a plurality of circumferentially spaced apart attachment locations. This form of attachment does not affect the inflated inflatable bladder 511 forming a complete turn of bulge or protrusion, but helps to promote the follow-up of the first portion 51 of the cover 50 to the struts of the atrial segment 11. It will be appreciated that the number and placement of the attachment sites is not limited, e.g., attachment sites may be provided only at some, but not all, of the junctions of the first and second struts 1231, 1233, and that, e.g., one or more spaced attachment sites may be provided at a central portion of one or more struts of the atrial segment 11, etc., the placement of the attachment sites may help to promote the follow-up of the first portion 51 of the cover 50 to the struts of the atrial segment 11, enabling the first portion 51 of the cover 50 to be compressed more uniformly when the atrial segment 11 is crimped to a compressed configuration.

With particular reference to fig. 4b, 5 and 6, from the opening 57 to the path of the inflation bladder 51, where the blood supply flow is flushed, as defined between the second and third portions 53, 55 of the cover 50, there is a section 124 of reduced radial clearance between the outer and inner valve frames 12, 14, the reduced radial clearance section 124 defining a radial clearance value that is less than the radial clearance value elsewhere on the path of the blood supply flow, such that the reduced radial clearance section 124 constitutes a narrowing on the path of the blood supply flow. As blood flow passes through this reduced radial clearance section 124, the increased flow rate and pressure of the blood flow, due to the narrowed path, can enable rapid filling of the inflatable bladder 51, so that the inflatable bladder 51 transiently fills the gap between the atrial segment 11 and the annulus tissue, preventing paravalvular leakage, and also helping the inflatable bladder 51 to be sufficiently filled to accommodate the smaller, less-easily filled gap between the atrial segment 11 and the annulus tissue. In addition, during diastole, the reduced radial gap segment 124 can block blood flow from exiting the inflatable bladder 51 downward, and then during the next systole, the time required for blood flow to flush into, fill the inflatable bladder 51 to a sufficient extent is shorter, thereby more rapidly and effectively preventing paravalvular leakage.

The present invention is not limited by the manner in which the reduced radial clearance section 124 is configured, as may be a partial section of the outer layer valve frame 12 that is recessed radially inward and/or a partial section of the inner layer valve frame 14 that is protruding radially outward. In this embodiment, as shown in fig. 6, the section of the outer layer petal frame 12 corresponding to the transition section 13 is configured as a radially inward recessed reduced diameter section, and as the name implies, the radial dimension of the reduced diameter section is reduced compared to the radial dimension of the section of the outer layer petal frame 12 adjacent to the reduced diameter section.

Specifically, in connection with fig. 7 to 8d, the reduced diameter section includes a plurality of transition struts 121 distributed in the circumferential direction. Each transition strut 121 comprises a first end 1211 connected to a corresponding ventricular segment 15 of the outer layer frame 12 and a second end 1213 connected to a corresponding atrial segment 11 of the outer layer frame 12, from said first end 1211 to said second end 1213, the transition struts 121 extending radially inwardly and then outwardly to form a radially inwardly recess while also extending axially upwardly and being curved circumferentially so as to assume a spatially curved configuration, in other words, the transition struts 121 extend axially while also being curved radially and circumferentially. The transition struts 121 extend in the axial direction a length sufficient to span the annulus of the native heart valve to be implanted. Because the transition support rod 121 with the space bending structure has circumferential bending, the force on the transition section 13 corresponding to the diameter-reduced section or the outer-layer valve frame 12, which is conducted by the atrial section 11, can be dispersed in the circumferential direction, and the force that the radial stress of the transition section 13 is possibly conducted to the inner-layer valve frame 14 to cause the valve She Kaige shape to be influenced can be correspondingly reduced, so that the influence on the opening and closing shapes of the valve leaves is effectively reduced.

The atrial segment 11 extends radially outwardly relative to the reduced diameter segment, receiving the description of the atrial segment 11 above, and the first and second struts 1231, 1233 comprising the unit 123 are also each circumferentially curved and have a uniform direction of curvature. This is advantageous, firstly, as an internal skeleton of the inflatable bladder 511, the circumferentially curved first and second struts 1231, 1233 have a greater physical length to bear against or abut the atrial side annulus tissue, providing better paravalvular leakage prevention; secondly, the compliance of the atrial segment 11 can be improved, so that the synchronicity of the movement of the atrial segment 11 following the cardiac cycle is improved, thereby reducing the damage of the atrial segment 11 to atrial tissue. Of course, the identical bending directions of the first support rod 1231 and the second support rod 1233 do not indicate that the bending shapes of the two support rods are identical, and the two support rods may be asymmetrically distributed with respect to the transition support rod 121.

Referring to fig. 6 and 7, in combination with fig. 4a to 5, the outer petal frame 12 further includes a connecting section 125 connected to the reducing section, and the connecting section 125 is used for connecting the upper end of the inner petal frame 14. Specifically, the connecting section 125 comprises a layer of undulating rods extending axially upward from the first end 1211 of the transition struts 121 to an upper section of the connecting section 125 located within the inflatable bladder 511. The upper section of the connecting section 125 supports the inflatable bladder 511 in conjunction with struts of the atrial section 11 such that a pre-set space exists before the inflatable bladder 511 is inflated, helping blood flow to more easily flush into the inflatable bladder 511.

The present invention is not limited to the connection form between the connection section 125 and the upper end of the inner petal frame 14, and may be a crimping, riveting, welding, sewing, or the like. Specifically, the embodiment is as follows: the upper ends of the inner petal rack 14 and the connecting section 125 are respectively provided with a rectangular inner connecting hole 145 and an outer connecting hole 1251; a plurality of turns 60, preferably greater than 2 turns, are wound around the respective edges of the inner 145 and outer 1251 connection holes that abut each other to effect the connection. The turns 60 are preferably medical sutures. Winding the turns 60 around the straight component edges of the rectangular attachment holes, rather than the generally circular holes, to effect the attachment, can allow the turns to be stressed centrally in the axial and/or radial directions without dispersing the attachment force of the turns 60 in the remaining directions, thus requiring a smaller number of turns 60 to securely attach the outer and inner valve holders 12, 14, which facilitates compression of the entire valve holder 10 and heart valve prosthesis 100 to a smaller size for delivery.

The invention is not limited to the positioning mode of the valve frame 10 and the heart valve prosthesis 100 in the heart, for example, a plurality of anchors can be arranged on the ventricular section 15 of the outer valve frame 12, the positioning can be implemented by the way that the anchors pierce the natural valve annulus and/or the valve leaflet tissue, the lower end of the outer valve frame 12 or/and the inner valve frame 14 is connected with a clamping structure capable of turning upwards, and the positioning can be implemented by the way that the clamping structure clamps the valve leaflet tissue with the ventricular section 15 of the outer valve frame 12; the ventricular section 15 of the outer shell frame 12 may also be configured to at least partially radially outwardly protrude relative to the first end 1211 of each of the transition struts 121 of the reduced diameter section to cooperate with the reduced diameter section to define an annular groove 135, with the annular groove 135 engaging the native annulus tissue for positioning. As shown in fig. 9b, the heart valve prosthesis 100 provided in this embodiment further comprises an anchoring ring 70 receivable within the annular recess 135. Before implanting the heart valve prosthesis 100, the anchoring ring 70 may be implanted prior to the implantation of the valve, and then the heart valve prosthesis 100 may be delivered into the anchoring ring 70 such that the anchoring ring 70 is inserted into the annular recess 135, with the leaflets and chordae tendineae therebetween being cinched by the anchoring ring 70 and the outer layer frame 12 of the heart valve prosthesis 100 to achieve stable positioning of the heart valve prosthesis 100.

Referring to fig. 10a and 10b, the heart valve prosthesis 200 according to the second embodiment of the present invention differs from the heart valve prosthesis 100 according to the first embodiment in that the first part 251 of the covering film is not redundant on the upper side of the atrial segment 11, but is attached in a flattened form to the upper side of the atrial segment 11, and the flattened film body can be sewn to the struts of the atrial segment 11 and to the connecting segments 125 by means of sutures. That is, in this embodiment, the first portion 251 of the cover film is redundant only on the underside of the atrial segment 11 to form an inflatable bladder 2511. Other identical structures and functions are not repeated here.

Referring to fig. 11, the heart valve prosthesis 300 according to the third embodiment of the present invention is different from the heart valve prosthesis 100 according to the first embodiment in that the upper redundant partial section such as the middle section 3513 is sewn to the struts of the atrial segment 11 by stitching, i.e. the upper redundant is not completely free, although there is also redundancy in the upper side of the atrial segment 11 by the first portion 351 of the covering film. In addition, the first portion 351 of the cover is more redundant and looser on the underside of the atrial segment 11, so that the inflatable balloon 3511 is more bulky, can hold more of the amount of blood flushed, and is suitable for situations where there is a larger gap between the atrial segment 11 and the annular tissue. Other identical structures and functions are not repeated here.

Referring to fig. 12, in comparison with the heart valve prosthesis 100 of the first embodiment, although the first portion 451 of the covering film is redundant on the lower side of the atrial segment 11, the redundant portion of the lower side is continuously connected with each strut of the atrial segment 11 by means of suture, for example, continuously sewn on the first strut 1231 and the second strut 1233 of each unit 123 shown in fig. 6-8 d, and of course, the film body of the first portion 451 between the first strut 1231 and the second strut 1233 is still redundant and loose. In this case, after the blood is infused into the inflatable bladder 4511 such that the inflatable bladder 4511 fills and expands, the inflatable bladder 4511 is divided into a plurality of small bladder units 4513, and the continuously stitched portions form the boundaries of each bladder unit 4513, so that the blood flows into each bladder unit 4513 from bottom to top. It will be appreciated that in this embodiment, the first portion 4511 of the coating is optimal for the follow-up performance of the struts of the atrial segment 11. Other identical structures and functions are not repeated here.

Referring to fig. 13, compared with the heart valve prosthesis 400 of the fourth embodiment, the heart valve prosthesis 500 of the fifth embodiment of the present invention adopts a plurality of struts distributed circumferentially in different structures in the atrial section, the lower ends of two adjacent struts are connected to each other, the upper ends of the two adjacent struts are spread apart relatively to form a unit, the first portion 551 of the covering film has redundancy at the lower side of the atrial section, and the redundant partial sections at the lower side are continuously connected with each strut of the atrial section by means of suture. After the blood is infused into the inflatable bladder 5511 such that the inflatable bladder 5511 fills and expands, the inflatable bladder 5511 is divided into a plurality of small bladder units 5513, with the continuously stitched portions forming the boundaries of each bladder unit 5513, and the blood flow is infused from bottom to top down into each bladder unit 5513. Other identical structures and functions are not repeated here.

The above description is merely of a preferred embodiment of the present invention, the protection scope of the present invention is not limited to the above-listed examples, and any simple changes or equivalent substitutions of the technical solutions that can be obviously obtained by those skilled in the art within the technical scope of the present invention disclosed in the present invention fall within the protection scope of the present invention.

Claims (14)

1. A heart valve prosthesis for replacing a native mitral valve or tricuspid valve, comprising a valve frame and a cover; the valve frame includes an atrial segment and a ventricular segment, the atrial segment configured to extend radially outward relative to the ventricular segment; the cover includes a first portion encasing the atrial segment, the first portion of the cover being redundant at least on an underside of the atrial segment to form an inflatable balloon; the cover also defines an opening in communication with the inflatable bladder to supply blood to the inflatable bladder to inflate and expand the inflatable bladder.

2. The heart valve prosthesis of claim 1, wherein the open mouth is configured to be on a ventricular side and the open mouth faces downward.

3. The heart valve prosthesis of claim 2, wherein the valve frame comprises an outer valve frame and an inner valve frame fixedly disposed radially inward of the outer valve frame, a radial gap exists between the outer valve frame and the inner valve frame, the covering membrane further comprises a second portion connected to the first portion and overlying the outer valve frame, and a third portion connected to the first portion and overlying the inner valve frame, the opening is located between the second portion and the third portion of the covering membrane.

4. The heart valve prosthesis of claim 3, wherein the open mouth extends circumferentially through and around the third portion of the covering membrane.

5. The heart valve prosthesis of claim 3 or 4, wherein the second portion of the cover overlies an outer surface of the outer layer valve frame and the third portion of the cover overlies an inner surface of the inner layer valve frame.

6. The heart valve prosthesis of claim 3 or 4, wherein there is a section of reduced radial clearance between the outer and inner valve frames on the way from the open mouth to the inflatable pouch.

7. The heart valve prosthesis of claim 6, wherein the outer layer valve frame further comprises a reduced diameter section connected between the atrial section and the ventricular section, the reduced diameter section and the inner layer valve frame forming the reduced radial gap section therebetween.

8. The heart valve prosthesis of claim 1, wherein the first portion of the cover is also redundant on an upper side of the atrial segment.

9. The heart valve prosthesis of claim 1 or 8, wherein the atrial segment comprises a plurality of struts distributed circumferentially;

the first part of the coating film is freely covered on the plurality of struts; alternatively, the first portion of the covering film is connected to at least one of the struts at least one location; alternatively, the first portion of the cover is continuously connected with at least one of the struts.

10. The heart valve prosthesis of claim 7, wherein the reduced diameter segment comprises a plurality of transition struts circumferentially distributed, each transition strut comprising a first end connected to the ventricular segment and a second end connected to the atrial segment; from the first end to the second end, the transition struts extend radially inward and then outward while also extending axially upward and curving circumferentially to assume a spatially curved configuration.

11. The heart valve prosthesis of claim 10, wherein the atrial segment extends radially outward relative to the reduced diameter segment; the atrial segment comprises a plurality of units distributed along the circumferential direction, each unit comprises a first supporting rod and a second supporting rod, one end of each first supporting rod and one end of each second supporting rod are respectively connected with the second ends of two adjacent transition supporting rods, and the other end of each first supporting rod and the other end of each second supporting rod are connected with each other and smoothly transition; the first support rod and the second support rod are both bent along the circumferential direction.

12. The heart valve prosthesis of claim 7, wherein the reduced diameter segment and the ventricular segment together define an annular groove; the heart valve prosthesis further includes an anchoring ring receivable within the annular groove.

13. The heart valve prosthesis of claim 7, wherein the outer layer valve frame further comprises a connecting segment connected to the reduced diameter segment, the inner layer valve frame being connected to the connecting segment, a partial section of the connecting segment being located within the inflatable bladder.

14. The heart valve prosthesis of claim 13, wherein the inner valve frame and the connecting segment are each provided with a rectangular connecting hole, and a plurality of turns are wound around respective edges of the two connecting holes that abut each other to connect the inner valve frame and the connecting segment.