CN109549756B

CN109549756B - Heart valve

Info

Publication number: CN109549756B
Application number: CN201710872489.5A
Authority: CN
Inventors: 蒋坤; 刘香东; 姚斌; 周涵
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Shenzhen Jianxin Medical Technology Co ltd
Priority date: 2017-09-25
Filing date: 2017-09-25
Publication date: 2021-05-07
Anticipated expiration: 2037-09-25
Also published as: CN109549756A

Abstract

The present invention relates to a heart valve. A heart valve comprises a valve leaflet bracket and a choke element wrapped on the valve leaflet bracket, wherein the valve leaflet bracket is provided with a first end and a second end opposite to the first end, the valve leaflet bracket comprises a plurality of wave circles which are arranged at intervals along the axial direction of the valve leaflet bracket, the choke element covers the outer surface of the valve leaflet bracket, and the choke element is pressed into the wave circles of the valve leaflet bracket close to the second end at one end close to the second end of the valve leaflet bracket, so that the wave circles of the valve leaflet bracket close to the second end are positioned on the outer surface of the choke element. Above-mentioned heart valve, the choked flow piece is close to the one end of second end and is pressed in the valve leaflet support to the choked flow piece is difficult for blocking in the sheath pipe outside when going into the sheath, avoids the sheath pipe that the heart valve leads to when going into the sheath to the destruction of outer layer choked flow piece, can protect the choked flow piece not destroyed.

Description

Heart valve

Technical Field

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

Background

Heart valve disease is a very common heart condition, with valve damage from rheumatic heat being one of the most common causes. With the aging and the increasing population, senile valvular diseases and valvular diseases caused by coronary heart disease myocardial infarction are more and more common. These valvular lesions not only endanger life safety and affect quality of life, but also place a heavy burden and stress on the family and society. The heart of a human body is divided into four heart chambers, namely a left atrium, a left ventricle, a right atrium and a right ventricle, wherein the two atria are respectively connected with the two ventricles, and the two ventricles are connected with the two main arteries. The heart valve grows between the atrium and the ventricle and between the ventricle and the aorta, and plays the role of a one-way valve to help the blood flow move in a single direction. The four valves of the body are called the mitral valve, the tricuspid valve, the aortic valve, and the pulmonary valve, respectively. These valves, if diseased, can affect the movement of blood flow, causing cardiac dysfunction, ultimately leading to heart failure.

In recent years, percutaneous transcervical mitral valve replacement can be performed for patients with mitral stenosis and regurgitation, i.e. the procedure is performed by implanting a heart valve through an interventional and minimally invasive method, so that the patients avoid the pain of an open chest operation. When the existing heart valves such as stents and the like are usually implanted through a sheath tube, the free end of the flow blocking part is easily clamped outside the sheath tube when entering the sheath, and the flow blocking part is easily damaged to cause paravalvular leakage.

Disclosure of Invention

In view of this, there is a need for a heart valve that avoids the obstruction from becoming lodged outside the sheath during unsheathing.

A heart valve comprises a valve leaflet bracket and a choke element wrapped on the valve leaflet bracket, wherein the valve leaflet bracket is provided with a first end and a second end opposite to the first end, the valve leaflet bracket comprises a plurality of wave circles which are arranged at intervals along the axial direction of the valve leaflet bracket, the choke element covers the outer surface of the valve leaflet bracket, and the choke element is pressed into the wave circles of the valve leaflet bracket close to the second end at one end close to the second end of the valve leaflet bracket, so that the wave circles of the valve leaflet bracket close to the second end are positioned on the outer surface of the choke element.

Above-mentioned heart valve, the choked flow piece is close to the one end of second end and is pressed in the valve leaflet support to the choked flow piece is difficult for blocking in the sheath pipe outside when going into the sheath, avoids the sheath pipe that the heart valve leads to when going into the sheath to the destruction of outer layer choked flow piece, can protect the choked flow piece not destroyed.

Drawings

FIG. 1 is a schematic structural view of one embodiment of a heart valve;

FIG. 2 is a schematic view of the heart valve of FIG. 1 implanted in a heart;

FIG. 3 is a schematic partial structural view of the heart valve of FIG. 1;

FIG. 4 is a schematic structural view of a stent of the heart valve of FIG. 1;

FIG. 5 is a partial cross-sectional view of a stent of the heart valve of FIG. 1;

FIG. 6 is a schematic contour view of a skirt stent of the heart valve of FIG. 1;

FIG. 7 is a schematic view of the bracket of FIG. 4 at another angle;

FIG. 8 is a schematic plan view of the stent of FIG. 4 in an expanded configuration;

FIG. 9 is a partial cross-sectional view of the heart valve of FIG. 1 after attachment to the hollow wire cable;

FIG. 10 is a schematic view of an angled configuration of a connector of the heart valve of FIG. 1;

FIG. 11 is a schematic view of another angle of the heart valve of FIG. 1;

FIG. 12 is a schematic structural view of another embodiment of a heart valve;

FIG. 13 is a partial cross-sectional view of another embodiment of a heart valve coupled to a hollow wire cable;

FIG. 14 is an angled configuration of the connector of the heart valve of FIG. 13;

figure 15 is a partial cross-sectional view of another embodiment of a heart valve in cooperation with a hollow steel cable and sheath;

FIG. 16 is an exploded perspective view of the connector of the heart valve of FIG. 15;

FIG. 17 is a partial cross-sectional view of a stent of another embodiment of a heart valve;

FIG. 18 is a schematic structural view of a stent of another embodiment of a heart valve;

FIG. 19 is a schematic contour view of a skirt stent of the heart valve of FIG. 18;

FIG. 20 is a schematic assembled contour of the leaflets and skirt stent of the heart valve of FIG. 18;

FIG. 21 is a schematic view of a planar expanded configuration of a stent of another embodiment of a heart valve;

FIG. 22 is a schematic structural view of another embodiment of a heart valve;

FIG. 23 is a schematic structural view of another embodiment of a heart valve;

fig. 24 is a schematic structural view of another embodiment of a heart valve.

Detailed Description

To facilitate an understanding of the invention, the invention will now be described more fully with reference to the accompanying drawings. Preferred embodiments of the present invention are shown in the drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

It will be understood that when an element is referred to as being "secured to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," "up," "down," "far," "near," and the like as used herein are for illustrative purposes only.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Referring to fig. 1 and fig. 2, in the present embodiment, the structure of the heart valve 100 is described by taking a mitral valve stent as an example, but in other embodiments, the heart valve 100 is not limited to the mitral valve stent shown in fig. 1, and may also be other types of artificial valve stents, such as a pulmonary valve stent and an aortic valve stent.

Referring to fig. 2 and 3, the heart valve 100 includes a stent 110, a connecting member 130, a tether 150, a flow blocking member 170, and valve leaflets 190.

Referring to fig. 4, the stent 110 includes a leaflet stent 112, a skirt stent 114, and a link 116.

In the illustrated embodiment, the leaflet braces 112 are generally cylindrical in shape having a first end and a second end opposite the first end. In the illustrated embodiment, the first end is a distal end and the second end is a proximal end. The distal end of the heart valve represents the end of the valve that is distal to the operator during the procedure, and the proximal end represents the end of the valve that is proximal to the operator during the procedure. The leaflet brace 112 includes an undulating ring 1121 and a connecting rod 1123. The leaflet support 112 includes a plurality of wave rings 1121 arranged at intervals in the axial direction of the leaflet support 112 and a connecting rod 1123 connecting two adjacent wave rings. The wave rings 1121 provide radial support for the leaflet brace 112, and in the illustrated embodiment, the leaflet brace 112 includes three wave rings 1121.

The three wave rings 1121 are connected and fixed by a plurality of connecting rods 1123. In the illustrated embodiment, the number of the connecting rods 1123 is the same as the number of the wave troughs of the wave rings 1121, and one connecting rod 1123 is fixedly connected to the wave troughs of three wave rings 1121 at the same time. Of course, in other embodiments, the connecting rod 1123 may be fixedly connected to other positions of the wave ring 1121, such as the wave crest.

Referring to fig. 4 and 5, the skirt bracket 114 includes a supporting portion 1141 and a tilting portion 1143. The support portion 1141 extends from the leaflet support 112 radially outward of the leaflet support 112, and the tilted portion 1143 extends from one end of the support portion 1141 away from the leaflet support 112 to a first end of the leaflet support 112. The support portion 1141 is used for fixation of the heart valve 100 to the human mitral annulus of the heart 20, and the raised portion 1143 is used for preventing abrasion of the left atrial tissue by the edge of the skirt stent 114. Without the raised portion 1143, the distal edge of the radial support portion 1141 directly contacts the atrial tissue, which may cause a cutting effect on the atrial tissue under long-term heart beating, resulting in damage to the atrial tissue. With the raised portion 1143, the contact between the skirt support 114 and the atrial tissue becomes a surface contact, which increases the contact area, reduces the contact pressure, and avoids the cutting effect of the skirt support 114 on the cardiac tissue and the resulting abrasion.

In the embodiment shown in fig. 4, the support portion 1141 of the skirt stent 114 is fixed to the trough of the wave ring 1121 near the first end of the leaflet stent 112. Thus, when the heart valve 100 is implanted in the heart 20, approximately one third of the axial dimension of the leaflet frame 112 can be positioned in the left atrium, thereby avoiding the left ventricle outflow tract from being narrowed or even blocked due to the excessive implantation in the left ventricle.

It should be noted that the leaflet holders 112 are not limited to include the wave ring 1121 and the connecting rod 1123, and may have other structures, and the skirt holders are not necessarily connected to the valleys of the wave ring 1121. So long as it is ensured that the distance between the end of the skirt stent 114 close to the leaflet stent 112 and the first end is approximately 1/4-1/2, preferably one third, of the axial length of the leaflet stent 112. Of course, if desired, the distance between the first end and the different positions of the end of the skirt stent 114 close to the leaflet stent 112 along the circumferential surface may not be exactly the same, i.e., the different positions of the end of the skirt stent 114 close to the leaflet stent 112 in different circumferential directions.

In one embodiment, the width of the support portion 1141 of the skirt hanger 114 is 2mm to 6 mm. Here, the width of the support portion 1141 refers to a distance between one end of the support portion 1141 near the raised portion 1143 and the leaflet brace 112. The width of the support portion 1141 is 2mm to 6mm, which is approximately equal to the width from the inner side of the mitral valve annulus to the atrial wall of the human heart 20, i.e. the radial width of the valve annulus, so as to sufficiently ensure the fixation of the heart valve 100 on the mitral valve annulus of the human heart.

In one embodiment, the height of the tilting portion 1143 is 2mm to 6 mm. Here, the height of the tilted portion 1143 refers to a distance between one end of the tilted portion 1143 away from the supporting portion 1141 and one end close to the supporting portion 1141. Too low a height of the upturned portion 1143 may not prevent well abrasion of the edge of the skirt hanger 114 to heart tissue, and too high a height may damage other tissue of the left atrium.

Referring to fig. 6, the supporting portion 1141 of the skirt frame 114 has a circular ring shape and a circular outer contour when viewed from the inflow side of the valve blood flow, although the outer contour of the supporting portion 1141 may have other shapes.

Referring to fig. 7, in the illustrated embodiment, the skirt stent 114 comprises a plurality of skirt subunits, the skirt subunits having a substantially petal shape, and the skirt subunits are uniformly distributed along the circumference of the leaflet stent 112. Each skirt subunit includes a support portion 1141 and a tilting portion 1143.

Referring again to fig. 4, links 116 include a proximal link 1162, a leaflet brace link 1164, and a joint 1166. The proximal link 1162 is substantially rod-shaped. The leaflet support link 1164 is generally V-shaped and includes two struts extending from one end of the proximal link 1162, where one end of each strut distal from the proximal link 1162 is fixedly connected to two troughs adjacent to the undulating rings of the leaflet support 112 proximal to the second end. Each trough is connected to a strut such that the plurality of links 116 are evenly distributed along the second end to provide a guide when the heart valve 100 is retracted into the sheath to prevent the trough from becoming lodged outside the sheath. If the leaflet support links 1164 are attached to the leaflet support 112 at the peaks of the wave ring near the second end, the troughs can become lodged outside the sheath when the heart valve 100 is sheathed. In other embodiments, the leaflet support link 1164 further includes a fastening rod, a middle portion of the fastening rod is fastened to one end of the proximal link 1162 and is substantially perpendicular to the proximal link 1162, and two struts respectively extend obliquely from the middle portion of the fastening rod to an end away from the proximal link 1162 and are respectively fastened to two troughs adjacent to the wave ring of the leaflet support 112 near the second end.

A joint 1166 is formed at an end of the proximal link 1162 distal to the leaflet brace link 1164. In the illustrated embodiment, the joint 1166 is generally rod-shaped and extends perpendicular to the proximal link 1162, although in other embodiments, the joint 1166 may be disc-shaped or spherical.

In the illustrated embodiment, the entire stent 110, i.e., the leaflet stent 112, the skirt stent 114, and the link 116, are cut from the same tube and are formed as a single piece. A schematic plan-view unfolded structure of the stent 100 obtained by the integral cutting is shown in fig. 8. Of course, it should be noted that fig. 8 is an expanded view, and the stent 110 is still substantially tubular after being integrally cut from the tube, and is shaped into the shape shown in fig. 4 through a heat treatment process. The integrated cutting is split relatively and then assembled, so that the integrated cutting has the advantages of small radial size after compression and easiness in sheathing, and meanwhile, welding or splicing structures are cancelled at all parts of the support 100, so that the fatigue resistance of the support 100 is also improved. In the embodiment, the stent 110 is formed by cutting a superelastic nickel-titanium metal tube with a diameter of 6-10 mm and a wall thickness of 0.3-0.5 mm.

Referring to fig. 1, 4, 9 and 10, the joint 1166 of the connecting rod 116 of the bracket 110 is connected to the connecting member 130. The connecting member 130 includes a socket 132 and a connecting cover 134, and the joint 1166 of the connecting rod 116 is received in the cavity formed by the socket 132 and the connecting cover 134. In the illustrated embodiment, the socket 132 has a substantially cylindrical shape, one end of which is recessed to form a receiving slot 1322, and the other end of which is opened with a screw hole 1324. In the illustrated embodiment, the threaded bore 1324 communicates with the receiving slot 1322. Specifically, the end of the socket 132, which is provided with the screw hole 1324, gradually shrinks into a frustum shape. In one embodiment, the heart valve 100 further comprises a hollow steel cable 30 for assisting in the delivery of the heart valve 100. The threaded hole 1324 is connectable to a hollow wire cable 30 for transporting the heart valve 100, and one end of the hollow wire cable 30 is threaded to be threadably engaged with the threaded hole 1324, so that the one end of the hollow wire cable 30 is fixed to the connector 130 and can be disconnected by rotation. The hollow wire cable 30 can act to push and pull the heart valve 100 when the heart valve 100 is being delivered in the delivery sheath, allowing the heart valve 100 to move within the delivery sheath lumen, and the heart valve 100 can also be pulled back into the delivery sheath again by the hollow wire cable 30 after the heart valve 100 is released from the delivery sheath. In the illustrated embodiment, the depth of the threaded hole 1324 is approximately equal to the length of the threads at one end of the hollow cable 30, although in other embodiments the depth of the threaded hole 1324 is greater than the length of the threads at one end of the hollow cable 30.

The connection cover 134 is covered and fixed on the accommodation groove 1322. In the illustrated embodiment, the connection cover 134 is accommodated in the accommodation groove 1322 and fixed to a groove wall of the accommodation groove 1322 by welding. The connecting cover 134 is provided with a plurality of limiting holes 1342, and each limiting hole 1342 extends from the end of the connecting cover 134 to the center. Each connecting rod 116 is disposed through a limiting hole 1342, and the joint 1166 is received in the receiving slot 1322. Tab 1166 abuts a side surface of connecting cover 134 adjacent to threaded bore 1324. In the illustrated embodiment, the tab 1166 has at least one dimension that is larger than the diameter of the limiting hole 1342 to prevent the tab 1166 from falling out of the limiting hole 1342.

A stopper 152 is formed at one end of the tether 150. The tether 150 is inserted into the screw hole 1324 and the blocking portion 152 is received in the receiving slot 1322. The one-dimensional size of the blocking portion 152 is larger than the inner diameter of the screw hole 1324, thereby preventing the blocking portion 152 from falling off from the screw hole 1324. The tether 150 is made of at least one material selected from polyester, nylon, ultra-high molecular weight polyethylene, nickel titanium, and stainless steel woven wires. In the illustrated embodiment, the blocking portion 152 is a knot formed by knotting one end of the tether 150. Of course, in other embodiments, other structures formed at one end of tether 150 may be used as long as they can avoid falling out of threaded hole 1324. In use, the tether 150 extends outwardly from the receptacle 1322 and through the inner bore of the hollow cable 30 to prevent the blocking portion 152 from being directly exposed to the ventricle and causing a thrombus; while also preventing unrestrained distal movement of stop 152.

In the illustrated embodiment, the connection cover 134 has a plate shape with a uniform thickness. In other embodiments, a boss is formed at the middle of the side of the connection cover 134 close to the screw hole 1324, the boss abuts against the wall of the receiving groove 1322, the connectors 1166 are received in the receiving groove 1322, the connectors 1166 are wound around the boss, at this time, the connection cover 134 is provided with a through hole through which the tether 150 can pass, and the tether 150 passes through the through hole and the blocking portion 152 abuts against a side surface of the connector 1166 of the connection cover 134. Of course, in order to ensure uniform stress, the through hole is opened in the middle of the connection cover 134 and penetrates through the boss.

In the illustrated embodiment, the threaded bore 1324 extends into the receptacle 1322 so that they are in communication. Of course, in other embodiments, the screw hole 1324 communicates with the housing slot 1322 by forming a through hole through which the tether 150 passes. Of course, in other embodiments, the hollow steel cable 30 may also be provided with a screw hole, the corresponding socket 132 may be provided with an external thread to be screwed with the screw hole, and at this time, the socket 132 may be provided with a through hole for the tether 150 to pass through.

Referring to fig. 5 again, fig. 5 is a partial cross-sectional view of the heart valve 100, and the angle α of the connecting rod 116 is 40 ° to 60 ° when the heart valve 100 is in the open state. The angle α of the link 116 refers to the angle between the line defined by the point of attachment of the link 116 to the leaflet brace 112 and the point of attachment of the link 116 to the connector 130 and the axis of the leaflet brace 112. In the illustrated embodiment, the link 116 is linear, and the angle of the link 116 is the angle between the α link 116 and the axis of the leaflet brace 112. The valve leaflet supports 112 with the angles alpha of the connecting rods 116 with different angles are tested in the sheath tube with the inner diameter of 11mm, the relation between the sheathing force of the valve leaflet supports 112 with the angles alpha of the connecting rods 116 with different angles in the sheath tube with the inner diameter of 11mm and the supporting strength of the valve leaflet supports 112 is tested, and the fact that the sheathing force can be controlled in a lower range when the angles alpha of the connecting rods 116 are 40-60 degrees is found, and the strength of the valve leaflet supports 112 can reach the maximum range. Of course, all parameters of the leaflet braces 112 tested using the angle α of each different link 116 are the same except for the link 116 angle α. Preferably, the included angle α of the connecting rod 116 is 45 ° to 60 °.

Referring again to fig. 2, the heart valve 100 also includes a spacer 160. The material of the gasket 160 is at least one selected from polyester, nylon, ultra-high molecular weight polyethylene, nickel titanium and stainless steel woven wire. The gasket 160 may be a felt-like disc, a titanium-nickel wire knitted disc, or a polymer injection molded disc. When heart valve 100 is implanted in human heart 20, the end of tether 150 distal to link 116 is passed through heart 20 and spacer 160 and tied to form anchor 154 secured to spacer 160.

The resistive element 170 is configured to block blood flow from escaping through the stent 110, and cooperates with the valve leaflets 190 to ensure unidirectional blood flow within the heart valve 100. Referring to fig. 5 and 11, the outer surfaces of the leaflet holders 112 and the skirt holders 114 are covered with the flow blocking element 170, and the flow blocking element 170 on the outer surface of the leaflet holder 112 is pressed into the wave ring 1121 on the second end of the leaflet holder 112 at an end close to the second end of the leaflet holder 112, so that the wave ring 1121 on the second end of the leaflet holder 112 is located outside the flow blocking element 170, thereby preventing the free end of the flow blocking element 170 from being easily stuck outside the sheath and protecting the flow blocking element 170 from being damaged when the flow blocking element 170 is inserted into the sheath. In the illustrated embodiment, both surfaces of the leaflet holders 112 and skirt holders 114 are covered with flow blockers 170. Specifically, one end of the flow blocking element 170 extends from the second end of the leaflet frame 112 along the inner surface of the leaflet frame 112 to the first end, then extends along the outer surface of the leaflet frame 112 to the inner surface of the skirt frame 114, and finally extends along the outer surfaces of the skirt frame 114 and the leaflet frame, and is pressed into the wave ring 1121 of the leaflet frame 112 when reaching the wave ring 1121 near the second end of the leaflet frame 112. In the illustrated embodiment, the wave ring 1121 of the leaflet brace 112 near the second end has a wave height (a vertical distance between a peak and a trough) of 4-8 mm, and the number of peaks or troughs is 8-16.

In the illustrated embodiment, the resistive element 170 is a fabric (e.g., knitted polyester fabric) that increases the resistance of the skirt stent and the leaflet stent, and reduces the risk of paravalvular leakage after the heart valve 100 is implanted in the human heart. Meanwhile, the surface roughness of the fiber cloth is large, the circumferential friction of the heart valve 100 is large, and the fixation is convenient. Of course, in other embodiments, the portion covering the outer surface of the skirt stent and the outer surface from the connection point of the skirt stent and the leaflet stent to the second end of the leaflet stent may be polyester knitted fabric, and the other portion may be conventional film-coated materials such as PET, PU, casing, animal core, or the like.

In the illustrated embodiment, the end of the blocker 170 proximate to the link 116 is secured by a suture. The choke 170 is sewn to the tie bar by a suture.

The fiber cloth has radial variability as the flow resistance element 170, so that stents of different radial dimensions can be wrapped by the same flow resistance element 170, for example, the skirt stent and the leaflet stent can be wrapped by the same flow resistance element 170, and the flow resistance element 170 is fixed by radial pressure.

The surface of the skirt stent 114 is covered with the flow blocking part 170, so that the contact area of the skirt stent 114 and the heart tissue can be increased, the contact pressure can be reduced, the climbing of the heart endothelial tissue on the surface of the heart valve 100 can be accelerated, and the thrombus source of the heart valve 100 can be reduced. In one embodiment, to accelerate the coating of the endothelial tissue on the surface of the heart valve 100, the non-biological tissue surface of the heart valve 100 is formed with a parylene layer. In one embodiment, the surface of the flow resistor 170 is formed with a parylene layer. The thickness of the parylene layer is 1-5 microns. Preferably, the material of the parylene layer is parylene C.

It is understood that the fiber cloth can increase the flow resistance of the skirt stent and the leaflet stent, thus eliminating the need for other flow-resistant materials. In other embodiments, the spoiler 170 may also be a double-layer or multi-layer structure, such as in other embodiments, a conventional film-coated material, such as PET, PU, sausage casing, or animal core, is coated on the inside of the fiber cloth.

Referring again to fig. 3, the leaflets 190 are positioned within the leaflet braces 112 and are secured to the flow resistance elements 170 on the inner surface of the leaflet braces 112. Of course, in other embodiments, when the flow blocking element 170 is not disposed on the inner surface of the leaflet frame 112, the leaflet 190 may be directly fixed to the leaflet frame 112. The leaflet 190 is cut from the animal pericardium. In the illustrated embodiment, the leaflets 190 are generally fan-shaped, having a total of three pieces, arranged in series along the circumference of the leaflet brace 112. The ends of the adjacent two leaflets 190 near the inner surface of the leaflet support 112 are joined together to form a leaflet angle 192, and the peripheral edges of the leaflets 190 are fixed to the leaflet support 112 and the flow preventing member 170 by sewing. In one embodiment, the angle 192 is fixed to the connection of the link 116 to the leaflet brace 112, thereby increasing the strength of the connection and ensuring proper opening and closing of the leaflets 190.

In one embodiment, a hydrogel layer (not shown) is disposed between the blocker 170 and the bracket 110. The material of the hydrogel layer is at least one selected from polyvinyl alcohol and polyurethane. In one embodiment, the hydrogel layer is coated on a surface of the spoiler 170 adjacent to the bracket 110. Of course, in other embodiments, the hydrogel layer may also be secured between the spoiler 170 and the bracket 110 by stitching. When the heart valve 100 is implanted in the human heart 20, the hydrogel swells in the presence of water, expanding the site corresponding to the flow stop 170. If a gap exists between the heart valve 100 and the mitral valve tissue after being implanted into the heart of a human body, the expanding hydrogel layer causes the flow blocking member 170 to bulge outward, thereby blocking the gap and reducing the risk of paravalvular leakage.

When the heart valve 100 is implanted in the human heart 20, the skirt support 114 of the heart valve 100 secures the heart valve 100 to the mitral annulus, and the end of the tether 150 distal to the link 116 is tied through the heart 20 and the spacer 160 and secured thereto to prevent the heart valve 100 from being dislodged. The skirt support 114 is raised 1143 to prevent the skirt 114 from cutting and eroding the heart tissue.

The heart valve 100 described above has the following advantages:

1) the bracket 110 is integrally cut and formed, so that sheathing force and the risk of fracture failure can be reduced, welding is not needed, and the structural strength reduction caused by insufficient welding and the like can be avoided;

2) the support portion 1141 of the skirt support 114 is fixedly connected to the wave trough of the leaflet support 112 far from the wave ring 1121 of the connecting rod 116, so that when the heart valve 100 is implanted into the heart 20, approximately one third of the axial dimension of the leaflet support 112 can be positioned in the left atrium, thereby avoiding the left ventricular outflow tract from being narrow or even blocked due to too many valve supports 112 being implanted into the ventricle;

3) the screw hole 1324 is formed in one end, away from the connecting rod 116, of the connecting piece 130, so that the connecting piece can be fixed with or released from the hollow steel cable 30 in a rotating mode, the connecting piece and the hollow steel cable 30 are not easy to separate through screw connection, the connection stability is high, the hollow steel cable 30 can play a role in pushing and pulling the heart valve 100 in the process of implanting the heart valve 100, the heart valve 100 can move in the inner cavity of the conveying sheath, and after the heart valve 100 is released from the conveying sheath, the heart valve 100 can be pulled back to the conveying sheath again through the hollow steel cable 30;

4) the angle alpha of the connecting rod 116 is 40-60 degrees, the sheathing force can be controlled in a lower range, and the strength of the valve leaflet bracket 112 can reach the maximum range;

5) the end of the flow blocking piece close to the second end is pressed into the valve leaflet support, so that the flow blocking piece is not easy to clamp outside the sheath tube when entering the sheath, the damage of the sheath tube to the outer flow blocking piece caused by the heart valve when entering the sheath is avoided, and the flow blocking piece can be protected from being damaged.

Referring to fig. 12, another embodiment of a heart valve 300 has substantially the same structure as the heart valve 100, except that: tether 350 comprises a plurality of filaments secured together, with an end of tether 350 distal to attachment element 330 forming a petal-shaped anchor 354. The anchoring portion 354 may be deployed and secured at the apex of the heart to act as a pull on the heart valve 300 and prevent the heart valve 300 from falling off on the left atrium side.

It should be noted that the multi-strand monofilament of the tether 350 may be fixed by gluing, steel sleeve fixing and pressing, winding and fixing, heat shrink tube fixing, and the like.

Of course, in some embodiments, the petal-shaped anchors 354 may be formed by cutting a nitinol tube, and then heat treating to set the petals. The compressed size of the anchoring portion 354 is smaller than the inner diameter of the hollow wire rope 30, so that the anchoring portion 354 can be contracted inside the hollow wire rope 30 and can be relatively moved.

Referring to fig. 13 and 14, another embodiment of a heart valve 400 has substantially the same structure as the heart valve 100, except that: the ends of the links 416 remote from the leaflet holders are not provided with a joint, and the ends of all the links 416 are welded to form a ball 4166, which is received in the receiving groove 4322 and abuts against the connecting cover 434.

Correspondingly, the number of the limiting holes 4342 is one.

In one embodiment, the connecting cover 434 is a two-piece structure, and the two pieces cooperate to form the limiting hole 4342, thereby facilitating installation.

Referring to fig. 15 and 16, another embodiment of a heart valve 500 has substantially the same structure as the heart valve 100, except that: the connection cap 534 of the connection member 530 includes a connection sleeve 5343 and a spherical cap 5344 formed at one end of the connection sleeve 5343, the connection sleeve 5343 is fixedly connected with the socket 532 in a sleeved manner, and the limiting hole 5342 is a strip-shaped hole extending along the axial direction of the connection sleeve 5343.

In the illustrated embodiment, the socket 532 includes a body portion 5325 and a plug portion 5326. The body portion 5325 is substantially hemispherical and has a flat end, and the diameter of the body portion 5325 is substantially the same as the diameter of the spherical cap 5344. The plug portion 5326 is protruded from the plane of the body portion 5235, and has a diameter smaller than that of the body portion 5325. The plug portion 5362 is received in the connecting sleeve 5343 and fixed thereto by welding. The screw hole 5324 penetrates the insertion portion 5326 and the body portion 5325. The limiting hole 5342 extends from one end of the connecting sleeve 5343 away from the spherical crown 5344 to the middle of the spherical crown 5344. Thus, when the linkage rod is coupled to the coupling cap 534, the angle of the linkage rod can be deflected within the position-limiting aperture 5342 by a small angle, and the linkage rod can adapt to different states of the heart valve 500 by changing the angle when the heart valve 500 is in the compressed state and the uncompressed state.

In the illustrated embodiment, the connector 530 further includes a catch 536. The blocking piece 536 is accommodated in the connecting sleeve 5343 and is located at one end of the insertion portion 5326 close to the spherical cap 5344. The middle portion of the blocking plate 536 is provided with a through hole 5362 corresponding to the screw hole 5324. The stopper 552 at one end of the tether 550 is spherical and has a diameter greater than that of the through hole 5362. The blocking portion 552 is located on a side of the blocking piece 536 away from the inserting portion 5326 and abuts against the blocking piece 536. Of course, the blocking piece 536 may be omitted, and the blocking portion 553 may have a size larger than the screw hole 5324 and abut against the insertion portion 5326.

The hemispherical shape of the connecting member 530 at both ends reduces the stroke of thrombus and the influence on the hemodynamics.

Referring to fig. 17, another embodiment of a heart valve 600 has substantially the same structure as the heart valve 100, except that: a gap is formed between the flow blocker 670 located on the surface of the skirt stent 614 near the first end of the leaflet stent 612 and the skirt stent 614.

In the illustrated embodiment, the blocker 670 is a fabric cloth, the blocker 670 wraps around and is sewn to the surfaces of the skirt stent 614 and the leaflet stent 612, and the blocker 670 forms a gap with the surface of the support portion 6141 of the skirt stent 614 away from the link 616. Specifically, one end of the blocker 670 is attached to the inner surface of the leaflet holder 612 from the second end of the leaflet holder 612 to the first end and is pulled radially from the first end toward the raised portion of the skirt holder 614, and is attached to the surface of the skirt holder 614 near the link 616 to the outer surface of the second end of the leaflet holder 612, and the two ends of the blocker 670 are secured together by a suture at the second end of the leaflet holder 612. Preferably, the height of the portion of the flow-blocking piece 670 corresponding to the support portion 6141 is approximately flush with the end surface of the first end of the leaflet brace 612.

The surface of the skirt stent 614 away from the connecting rod 616 is not contacted by the flow resisting element 670 and the surface of the skirt stent 614, so as to avoid blood flow disturbance caused by the protrusion of the end of the leaflet stent 612 away from the connecting rod relative to the support part 6141 of the skirt stent 614. Preferably, the pore size of the fiber cloth on the side of the support portion away from the connecting rod 616 is smaller than the size of the thrombus formed, so that the thrombus formed in the cavity formed by the fiber cloth in the skirt stent 614 can not escape from the cavity, and various complications caused by the thrombus can be prevented.

Referring to fig. 18 and 19, another embodiment heart valve 700 has substantially the same structure as heart valve 600, except that: the outer profile of the support portion 7141 is D-like.

Here, the outer contour of the support portion 7141 in an orthogonal projection to a plane perpendicular to the axis of the leaflet brace 712 may also be considered to be D-like. It is understood that in some embodiments, the orthographic projection of the support portion 7141 on a plane perpendicular to the axis of the leaflet support 712 can also be discontinuous, in which case the outer contour refers to a smooth curve obtained by fitting a curve to the orthographic projection. In some embodiments, the support 7141 is surface-covered with flow-blocking elements, and the outer profile refers to the outer profile of the orthographic projection of the support 7141 of the skirt stent 714 surface-covered with flow-blocking elements in a plane perpendicular to the axis of the leaflet stent 712.

Because the contour of the mitral valve annulus to which the mitral valve of a human heart is attached is D-like, and the support portion 7141 of the skirt bracket 714 functions to fix the heart valve 700 on the mitral valve annulus, the support portion 7141 with the D-like outer contour can better conform to the contour of the mitral valve annulus, thereby preventing paravalvular leakage.

In one embodiment, the support portion 7141 has the same outer contour as the mitral annulus to which a human heart mitral valve is attached.

In one embodiment, the outer profile of the support portion 7141 in an orthographic projection of a plane perpendicular to the axis of the leaflet support 712 includes a first region 7144 that is circumferentially distributed and a second region 7145 connected to the first region 7144. In the illustrated embodiment, the angle β defined by both ends of the first region 7144 and the perpendicular to the axis of the leaflet brace 712 is between 100 ° and 140 °. The distance between the end of the support portion 7141 that is distal from the leaflet support 712 (i.e., the width of the support portion 7141) and the leaflet support 712 in the first region 7144 is less than the distance between the end of the support portion 7141 that is distal from the leaflet support 712 and the leaflet support 712 in the second region. Preferably, the width of the supporting portion 7141 positioned in the first region 7144 is 2 to 4 mm. The width of the supporting portion 7141 positioned in the first region 7144 is smallest at the middle line position of the first region 7144 and gradually increases toward both ends. The distances between the end of the support section 7141 located in the second region 7145 away from the leaflet braces 714 and the leaflet braces 712 are all equal and are 2mm to 6mm, i.e., the width of the support section 7141 located in the second region 7145 is 2mm to 6 mm. The angle defined by the two ends of the second region 7145 and the perpendicular to the axis of the leaflet braces 712 ranges from 220 deg. to 260 deg.. Particularly in the present embodiment, the width of the supporting portion 7141 located in the first region 7144 at the position of the midline of the first region 7144 is 50% of the width of the supporting portion 7141 located in the second region 7145.

Referring to fig. 20, in one embodiment, the leaflets 790 have three total flaps, wherein the angle γ defined by the perpendicular to the axis of the leaflet support 712 at the angle 792 and the perpendicular to the axis of the leaflet support 712 at the center of the first region 7144 is between 0 ° and 30 °. More preferably, one of the flap angles 792 corresponds to the center of the first region 7144, i.e., a line defined by one of the flap angles 792 and the center of the first region 7144 is perpendicular to the axis of the leaflet brace 712, when γ is 0 °. When the first region 7144 is subjected to radial pressure from heart tissue on the aortic root side of the mitral annulus, corresponding deformation of the corresponding side of the leaflet braces 712 can result in a change in the distance between the valve corners 792, resulting in a restricted opening and closing function of the leaflets 790, eventually resulting in the leaflets 790 not closing fully and regurgitating or opening stenosis. The angle y defined by one of the lobe angles 792 from 0 to 30, normal to the axis of the leaflet support 712 and the center of the first region 7144 from normal to the axis of the leaflet support 712 can minimize the effects of leaflet 790 deformation.

Referring to fig. 21, another embodiment heart valve 800 has substantially the same structure as heart valve 700, except that: the skirt support is provided with a positioning member 8147.

In one embodiment, the positioning element 8147 corresponds to the center of the first region, and when installing the valve leaflets, an included angle γ defined by a perpendicular line between one of the valve corners and the axis of the leaflet brace and a perpendicular line between the center of the first region and the axis of the leaflet brace is 0 ° to 30 °, and when releasing the heart valve, the position of the heart valve can be adjusted by the positioning element 8147 so that the valve corner is located at the center of the anterior leaflet of the mitral valve.

In one embodiment, the skirt hanger is further provided with an auxiliary member 8148 to facilitate positioning of the positioning member 8147 upon release. The auxiliary parts 8148 are two in number and are respectively positioned on two sides of the positioning part 8147, and the shapes of the positioning part 8147 and the auxiliary parts 8148 are different. In the illustrated embodiment, the positioning member 8147 is "8" shaped and the auxiliary member 8148 is circular.

Preferably, the angle defined by the perpendicular to the axis of the leaflet support 712 for each of the adjuncts 8148 and the perpendicular to the axis of the leaflet support 712 for the center of the first region 7144 is 30 °.

In one embodiment, the leaflet braces 712 are also provided with a leaflet mounting hole 8189. Preferably, there are three lobe angle mounting holes 8189, one of the lobe angle mounting holes 8189 corresponding to the positioning member 8147. What corresponds here is meant is that the perpendicular to the axis of the leaflet support 712 from the valve corner mounting hole 8189 and the projection of the perpendicular to the leaflet support from the positioning member 8147 onto a plane perpendicular to the axis of the leaflet support coincide with one another.

In this embodiment, the positioning member 8147 and the auxiliary positioning member 8148 are formed by forming a mounting hole in the skirt support and embedding a developing material such as gold, platinum, or tantalum in the mounting hole. The shape of the positioning member 8147 is not limited to the "8" shape, and may be other shapes that can be easily observed under X-rays, such as a circle, a square, or a polygon, as long as the positioning member 8147 and the auxiliary member 8148 can be distinguished.

It is also understood that the positioning member 8147 and the auxiliary positioning member 8148 can be provided in other developing structures. For example, the positioning member 8147 and the auxiliary positioning member 8148 may also be a developing coating layer coated on the corresponding position of the flow blocking member.

Referring to fig. 22, another embodiment of a heart valve 900 has substantially the same structure as the heart valve 100, except that: the profile of one end of the resistive element 970 near the second end of the leaflet brace is the same as the profile of the second end of the leaflet brace.

In the illustrated embodiment, the wave ring 9121 is located at one end of the leaflet support near the link 916 and is fixedly connected to the link 916, the profile of the second end of the leaflet support, i.e., the profile of the wave ring 9121, is saw-toothed, the profile of the end of the flow blocking element 970 near the second end of the leaflet support is saw-toothed and is the same as the profile of the second end of the leaflet support, and the end of the flow blocking element 970 near the second end of the leaflet support is fixed to the wave ring 9121 by sewing thread.

Of course, in other embodiments, the second end of the leaflet frame is not serrated, and the shape of the end of the flow blocking element 970 near the second end of the leaflet frame may be modified accordingly, so long as the profiles of the two are the same, the flow blocking element 970 may be prevented from protruding when the sheath is retracted.

Referring to fig. 23, another embodiment of a heart valve 1000 has substantially the same structure as the heart valve 1000, except that: the flow-impeding element 1070 includes a first flow-impeding film 1071 covering the inner surface of the leaflet stent 1010 and a second flow-impeding film 1072 covering the outer surface of the leaflet stent 1012 and the surface of the skirt stent 1014.

In the illustrated embodiment, the first blocker film 1071 extends from an end of the leaflet support 1012 distal from the link 1016, along an inner surface of the leaflet support 1012, to an end of the leaflet support 1012 proximal to the link 1016. The second blocker film 1072 wraps the leaflet stent 1012 and the skirt stent 1014 from the outer surface of the leaflet stent 1012 at the end distal from the link 1016 to the end of the leaflet stent 1012 proximal to the link 1016.

In the illustrated embodiment, an end of the second blocker film 1072 distal from the link 1016 is sewn to an end of the first blocker film 1071 distal from the link 1016 by a suture, and an end of the second blocker film 1072 proximal to the link 1016 is sewn to an end of the first blocker film 1071 proximal to the link 1016 by a suture.

In the illustrated embodiment, a gap is formed between the second blocker membrane 1072 of a side surface of the skirt hanger 1014 away from the link 1016 and the skirt hanger 1014. Preferably, the height of the portion of the second obstructing film 1072 corresponding to the support 10141 is approximately flush with the end of the leaflet braces 1012 distal from the link 1016.

In the illustrated embodiment, the first and second fluid-

resistant films

1071 and 1072 are each a fiber cloth, such as a fiber cloth or a plain weave, and the fiber linear weave density of the first fluid-resistant film 1071 is greater than the fiber linear weave density of the second fluid-resistant film 1072. The count of the fiber threads of the first obstructing film 1071 is greater than the count of the fiber threads of the second obstructing film 1072, so that the friction coefficient of the first obstructing film 1071 is less than that of the second obstructing film 1072, thereby improving the circumferential friction resistance of the heart valve and facilitating the fixation of the heart valve. Of course, in other embodiments, the first flow-resistant film 1071 may also be a conventional film-coated material such as PET, PU, sausage casing, or animal core.

Referring to fig. 24, another embodiment of a heart valve 1100 has substantially the same structure as the heart valve 100, except that: the blocker 1170 includes first and

second blocker films

1171, 1172, the first blocker film 1171 covering the inner surface of the leaflet holders 1112 and the surface of the skirt hanger 1114 at the end distal from the link 1116, and the second blocker film 1172 covering the outer surface of the leaflet holders 1112 and the surface of the skirt hanger 1114 at the end proximal to the link 1116.

In the illustrated embodiment, one end of the first resistive membrane 1171 is located at the junction of the leaflet holders 1112 and skirt holders 1114, and one end of the second resistive membrane 1172 is also located at the junction of the leaflet holders 1112 and skirt holders 1114. The other end of the second blocker film 1172 presses into the loop of the leaflet brace 1112 adjacent to the link 1116.

In the illustrated embodiment, the first flow-impeding membrane 1171 and the second flow-impeding membrane 1172 are both fiber cloth, such as fiber cloth or plain weave, and the fiber strand weave density of the first flow-impeding membrane 1171 is greater than the fiber strand weave density of the second flow-impeding membrane 1172, and the fiber strand count of the first flow-impeding membrane 1171 is greater than the fiber strand count of the second flow-impeding membrane 1172. Of course, in other embodiments, the first flow-resistant membrane 1171 may also be a conventional film-coated material such as PET, PU, sausage casing, or animal core.

It should be particularly noted that the above-mentioned technical solutions of 10 embodiments can be combined without contradiction, for example, the D-shaped supporting portion can be combined with the related solution of the fiber cloth, the D-shaped supporting portion can be combined with the connecting rod with different shapes, or the connecting rod with different shapes and the solution of the fiber cloth can be combined, and it is understood that the above-mentioned technical solutions can be combined.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A heart valve comprising a leaflet stent and a flow preventing element wrapped around the leaflet stent, wherein the leaflet stent has a first end and a second end opposite to the first end, the leaflet stent comprises a plurality of wave loops arranged at intervals along an axial direction of the leaflet stent, the flow preventing element covers an outer surface of the leaflet stent, and the flow preventing element presses the wave loops of the leaflet stent near the second end at an end near the second end of the leaflet stent, so that the wave loops of the leaflet stent near the second end are positioned on the outer surface of the flow preventing element; the flow blocking piece comprises a first flow blocking film and a second flow blocking film, the first flow blocking film covers the inner surface of the valve leaflet support, the second flow blocking film covers the outer surface of the valve leaflet support, the first flow blocking film and the second flow blocking film are both made of fiber cloth, and the fiber linear weaving density of the first flow blocking film is larger than that of the second flow blocking film.

2. The heart valve of claim 1, wherein the leaflet brace further comprises a connecting bar connecting two adjacent wave loops, the obstructing element being sewn to the connecting bar by a suture.

3. The heart valve of claim 1, wherein the fiber strands of the first flow-obstructing membrane have a greater count than the fiber strands of the second flow-obstructing membrane.

4. The heart valve of claim 1, wherein the first and second flow-blocking membranes are sutured at both ends by sutures.

5. The heart valve of claim 4, wherein an end of the second obstructing membrane adjacent to the first end is stitched to an end of the first obstructing membrane adjacent to the first end with a suture, and an end of the second obstructing membrane adjacent to the second end is stitched to an end of the first obstructing membrane adjacent to the second end with a suture.

6. The heart valve of claim 1, further comprising a skirt stent coupled to the leaflet stent, the skirt stent extending radially outward from the leaflet stent along the leaflet stent, the obstructing element covering at least one surface of the skirt stent.

7. The heart valve of claim 6, wherein the first flow blocking film extends from the first end of the leaflet frame to the second end of the leaflet frame along an inner surface of the leaflet frame, and the second flow blocking film wraps the leaflet frame from an outer surface of the first end of the leaflet frame and the skirt frame extends to the second end of the leaflet frame.

8. The heart valve of claim 7, wherein the second flow-obstructing membrane covers a surface of the skirt stent proximate to the first end of the leaflet stent, a gap being formed between the second flow-obstructing membrane and the skirt stent at the surface of the skirt stent proximate to the first end of the leaflet stent.

9. The heart valve of claim 1, wherein the wave ring of the leaflet brace near the second end has a wave height of 4-8 mm and a number of wave crests or wave troughs of 8-16.

10. The heart valve of claim 1, wherein a hydrogel layer is further disposed between the flow blocker and the leaflet brace.