CN110934664B

CN110934664B - Heart valve

Info

Publication number: CN110934664B
Application number: CN201811117062.5A
Authority: CN
Inventors: 刘香东
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Shenzhen Jianxin Medical Technology Co ltd
Priority date: 2018-09-25
Filing date: 2018-09-25
Publication date: 2022-12-16
Anticipated expiration: 2038-09-25
Also published as: CN110934664A

Abstract

The invention relates to a heart valve, which comprises a valve support and a tether, wherein the valve support comprises a main body support, a skirt edge support and a fixing piece, the skirt edge support and the fixing piece are respectively arranged on the main body support, and the tether is detachably connected with the main body support. During operation, after the fixing piece is fixed with the heart tissue through a push-pull test, the tether can be released from the valve support, and the tether is prevented from being left in the left ventricle to generate thrombus risk.

Description

Heart valve

Technical Field

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

Background

Valvular heart 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 and 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, 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 acts as a one-way valve to help the blood flow move in one direction. The four valves of the body are called the mitral valve, the tricuspid valve, the aortic valve, and the pulmonary valve, respectively. If these valves become diseased, they can affect the movement of blood flow, causing abnormal heart function and ultimately heart failure.

In recent years, percutaneous transcatheter mitral valve replacement has been performed for patients with mitral stenosis and regurgitation, i.e., the procedure is performed by implanting a heart valve through an interventional, minimally invasive method, which avoids the pain of an open chest procedure for the patient. There are also problems with existing heart valves.

Disclosure of Invention

It is an object of the present invention to provide a heart valve.

The heart valve comprises a valve support and a tether, wherein the valve support comprises a main body support, a skirt edge support and a fixing piece, the skirt edge support and the fixing piece are respectively arranged on the main body support, and the tether is detachably connected with the main body support.

In one embodiment, the main body frame includes a leaflet frame, a connecting rod and a connecting member, the skirt frame and the fixing member are disposed on the leaflet frame, one end of the connecting rod is fixedly connected with one end of the leaflet frame, the other end of the connecting rod is connected with the connecting member, and the tether is detachably connected with the connecting member.

In one embodiment, the connection member includes a socket and a connection cover fixedly connected to the socket, the connection cover is provided with a limiting hole, one end of the connection rod, which is far away from the leaflet bracket, penetrates through the limiting hole and is accommodated in a cavity formed by the connection cover and the socket, and the tether is detachably connected to the socket.

In one embodiment, the plug socket is of a hollow structure, a hanging rod is arranged in the plug socket, and one end of the tether penetrates through one end of the plug socket, which is far away from the connecting cover, and penetrates out of one end of the plug socket, which is far away from the connecting cover, after bypassing the hanging rod.

In one embodiment, the tether is a rigid structure and the tether is releasable from the receptacle by a rotational operation.

In one embodiment, the tether is threadably connected to the receptacle.

In one embodiment, a concave part is arranged on the tether, one end of the tether, which is close to the concave part, is fixedly connected with the plug socket, and the concave part is broken through a rotating operation.

In one embodiment, the connection cap includes a connection sleeve and a spherical cap formed at one end of the connection sleeve, which is far away from the spherical cap, is fixedly sleeved with the socket to form the cavity, and the limiting hole is disposed on the connection sleeve.

In one embodiment, the skirt hanger extends radially outward from the body hanger, the skirt hanger being further from the tether than the fastener.

In one embodiment, the fastener includes barbs disposed about the body support, the barbs extending radially outwardly from the body support, the axial distance between the end of the barbs adjacent the body support and the end of the skirt support adjacent the body support ranging from 5mm to 16mm.

When the heart valve is implanted into the heart, the heart valve can be fixed on the mitral valve ring by the skirt support of the heart valve, and one end of the tether, which is far away from the connecting rod, passes through the heart and the gasket and then is knotted for fixation, so that the displacement of the heart valve can be prevented. In the operation process, after the fixing piece is fixed with the heart tissue through the push-pull test, for example, after the barbs are ensured to hang on the valve leaflets of the human body, the tethers can be released from the valve support, the tethers are prevented from being left in the left ventricle to generate thrombus risk, if in the operation process, due to individual difference or operation deviation and other reasons, the fixing piece cannot be fixed with the heart tissue sometimes so as to fix the heart valve in the heart, the tethers can be reserved at the moment, the heart valve is fixed through the tethers, the success rate of the operation can be improved, and meanwhile, the applicability of the heart valve can also be improved.

Another embodiment of this application provides a heart valve, including valve support, tether and gasket, valve support include the main part support and set up in shirt rim support on the main part support, the gasket is provided with two at least through-holes, the one end of tether with the main part leg joint, the other end have two free ends, two the free end wears to locate respectively one of gasket behind the through-hole, it is fixed to tie a knot each other.

In one embodiment, the main body frame comprises a leaflet frame, a connecting rod and a connecting piece, the skirt frame is arranged on the leaflet frame, one end of the connecting rod is fixedly connected with one end of the leaflet frame, the other end of the connecting rod is connected with the connecting piece, and one end of the tether line, which is far away from the gasket, is connected with the connecting piece.

In one embodiment, the connection member includes a socket and a connection cover fixedly connected to the socket, the connection cover is provided with a limiting hole, one end of the connection rod away from the leaflet bracket penetrates through the limiting hole and is accommodated in a cavity formed by the connection cover and the socket, and one end of the tether line away from the gasket is connected to the socket.

In one embodiment, the socket is a hollow structure, a hanging rod is arranged in the socket, and one end of the tether, which is far away from the gasket, is arranged on the hanging rod in a sliding manner.

After the heart valve is implanted into the heart of a human body, the two free ends of the tether penetrate through the heart and the two through holes of the gasket, then the tether is knotted and fixed with the gasket, the perivalvular leakage condition of the heart valve after the heart valve is implanted into the heart can be diagnosed through an ultrasonic Doppler image in the operation process, and the effective length or tension of the tether is adjusted according to the diagnosis result in the knotting process, so that the adhesion force of the skirt support of the heart valve and the mitral valve annulus of the human body is improved, and the purpose of reducing the perivalvular leakage is achieved.

Drawings

FIG. 1 is a schematic structural view of a heart valve according to a first embodiment of the present application;

FIG. 2 is a schematic structural view of the heart valve of FIG. 1 from another perspective;

FIG. 3 is a partial plan expanded view of the valve stent shown in FIG. 1;

FIG. 4 is a schematic diagram of the configuration of barbs of the heart valve shown in FIG. 2;

FIG. 5 is a schematic structural view of another embodiment of the heart valve shown in FIG. 2;

FIG. 6 is a schematic view of a portion of the heart valve of FIG. 1 shown in connection with a hollow wire cable;

FIG. 7 is an exploded view of the structure shown in FIG. 6;

FIG. 8 is a schematic view of the receptacle of FIG. 6 connected to a tether;

FIG. 9 is a schematic structural view of the heart valve of FIG. 1 in one of its states of implantation in the heart;

FIG. 10 is a schematic view of the tether of FIG. 9 after attachment to the pad;

FIG. 11 is a schematic structural view of the heart valve of FIG. 1 in another state implanted in the heart;

FIG. 12 is a schematic view of a portion of a second embodiment of a heart valve of the present application;

FIG. 13 is a partial cross-sectional view of the receptacle of FIG. 11 shown coupled to a tether;

FIG. 14 is a schematic view of a portion of a heart valve according to a third embodiment of the present application;

fig. 15 is a schematic structural view of the docking station shown in fig. 14 after being connected with a tether.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.

It will be understood that when an element is referred to as being "secured to" or "disposed on" 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," and the like as used herein are for illustrative purposes only and do not represent the only embodiments.

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 herein in the description of the invention 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.

It should be noted that the present application is described with respect to a heart valve replacing a mitral valve, but the concepts of the present application can also be applied to a prosthetic heart valve replacing a tricuspid valve, a pulmonary valve, or an aortic valve. The heart valve tissue according to the present invention refers to one or a combination of several kinds of heart tissue such as valve annulus, valve leaflet, chordae tendinae, papillary muscle, and the like of the human body. In the delivery state, the heart valve is contracted in the delivery system, so that the delivery is facilitated; in the deployed state, the heart valve is disengaged from the delivery system and is secured in apposition to the heart tissue.

Referring to fig. 1 and 2, the heart valve 10 includes a valve support 100, a tether 150, a choke element 170 and valve leaflets 190, the valve support 100 includes a main body support 110, a skirt support 120 and a fixing element 130, the skirt support 120 and the fixing element 130 are respectively disposed on the main body support 110, the skirt support 120 and the fixing element 130 are respectively used for fixing heart tissues in two oppositely disposed cavities in the heart, and the tether 150 is detachably connected to the main body support 110. In this embodiment, skirt hanger 120 is used to fasten to the heart tissue on the left atrial side and fastener 130 is used to fasten to the heart tissue on the left ventricular side.

Referring to fig. 1 and 2, the main body frame 110 includes a leaflet frame 112, a connecting rod 114 and a connecting member 116, the skirt frame 120 and the fixing member 130 are disposed on the leaflet frame 112, one end of the connecting rod 114 is fixedly connected to one end of the leaflet frame 112, the other end is connected to the connecting member 116, and the tether 150 is detachably connected to the connecting member 116. Specifically, the skirt hanger 120 extends radially outward from the leaflet hanger 112, the skirt hanger 120 being further from the tether 150 than the fastener 130.

In the illustrated embodiment, the leaflet braces 112 are generally cylindrical in shape, having an inflow end and an outflow end opposite the inflow end. The leaflet brace 112 includes wave loops 1121 and connecting rods 1123. The leaflet brace 112 includes a plurality of undulations 1121 that are spaced axially along the leaflet brace 112. 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 tie bars 1123 is the same as the number of wave troughs of the wave rings 1121, and one tie bar 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.

The skirt hanger 120 includes a support portion 121 and a raised portion 122. The support portion 121 extends outward from the leaflet support 112 in the radial direction of the leaflet support 112, and the raised portion 122 extends from one end of the support portion 121 away from the leaflet support 112 to the inflow end of the leaflet support 112. The support portion 121 is used for fixation of the heart valve 10 at the human mitral annulus 62 of the heart 60, and the raised portion 122 is used to prevent abrasion of the left atrial tissue by the edge of the skirt holder 120. Without the raised portion 122, the distal edge of the radial support portion 121 is in direct contact with the atrial tissue, which may cause a cutting effect on the atrial tissue under long-term heart beats, resulting in damage to the atrial tissue. By providing the raised portion 122, the contact between the skirt support 120 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 120 on the cardiac tissue and the resulting abrasion.

The distance between one end of the support part 121 of the skirt stent 120 close to the leaflet stent 112 and the inflow end is 1/4-1/2 of the axial length of the leaflet stent 112. In the illustrated embodiment, the support portion 121 of the skirt stent 120 is fixedly attached to the valleys of the wave ring 1121 near the first end of the leaflet stent 112. Thus, when the heart valve 10 is implanted in the heart 60, approximately one third of the axial dimension of the leaflet frame 112 can be located in the left atrium, thereby avoiding stenosis or even obstruction of the left ventricular outflow tract due to excessive implantation in the left ventricle.

The width of the support part 121 of the skirt stent 120 is 2 mm-7 mm, so as to sufficiently ensure the fixation of the heart valve 10 at the mitral valve annulus 62 of the human heart. Here, the width of the support portion 121 refers to a distance between one end of the support portion 121 near the lifter 122 and the leaflet brace 112. In the present embodiment, the width of the support portion 121 is 4mm. The height of the raised part 122 is 2mm to 7mm. Here, the height of the tilted part 122 refers to a distance between one end of the tilted part 122 distant from the support part 121 and one end close to the support part 121. If the height of the raised portion 122 is less than 2mm, abrasion of the heart tissue by the edge of the skirt stent 120 cannot be prevented, and if the height is greater than 7mm, other tissues of the left atrium may be injured. In this embodiment, the height of the tilted portion 122 is 4mm.

In this embodiment, the outer contour of the support portion 121 of the skirt stent 120 is circular when viewed from the inflow side of the valve blood flow. Of course, in other embodiments, the outer contour of the supporting portion 121 may have other shapes, such as D-shaped, D-like, or elliptical.

With continued reference to FIGS. 1 and 2, the securing member 130 includes barbs 131 disposed around the body support 110, the barbs 131 extending radially outwardly from the body support 110, the axial distance between the end of the barbs 131 adjacent to the body support 110 and the end of the skirt support 120 adjacent to the body support 110 being in the range of 5mm to 16mm. Preferably, the axial distance between the end of the barb 131 adjacent the body bracket 110 and the end of the skirt bracket 120 adjacent the body bracket 110 is in the range of 10mm to 16mm. After the heart valve is implanted into the human heart 60, the mitral valve leaflets of the human body can be squeezed by the leaflet support 112 on the ventricular wall and keep an open state, the skirt support 120 of the heart valve 10 can be clamped on the mitral valve annulus 62 to prevent the heart valve 10 from falling into the left ventricle, the barbs 131 arranged on the leaflet support 112 can hook the lower edges of the human body leaflets, the axial freedom degree of the heart valve 10 can be bound under the pulling force of the valve chordae tendineae 63, the heart valve 10 is prevented from moving towards the left atrium, the probability of displacement of the heart valve after implantation is effectively reduced, and the barbs 131 can be hung on the human body leaflets without penetrating into the ventricular tissue, so that the barbs 131 can be prevented from rubbing with the ventricular tissue to damage the myocardial tissue around the ventricle, and the risk of puncturing the ventricular wall is avoided. Of course, in other embodiments, the axial distance between the end of the barbs 131 near the body support 110 and the end of the skirt support 120 near the body support 110 is in the range of 5mm to 10mm, and the barbs 131 can be fixed by piercing the mitral valve leaflets of the human body.

Specifically, the barbs 131 are disposed on the connection rods 1123 of the leaflet braces 112, and since the connection rods 1123 penetrate the inflow and outflow ends of the leaflet braces 112, they have a high rigidity, and when the barbs 131 are stressed, the connection rods 1123 can receive the force transmitted from the roots of the barbs 131, and the leaflet braces 112 are not locally deformed by the moment generated at the barbs 131.

The barbs 131 are cut. The cutting pattern of the barbs 131 is located at the end of the connecting rod 1123 of the leaflet holders 112 away from the inflow end, and breaks the barbs 131 off during setting. Referring to fig. 5, the connecting rod 1123 of the leaflet brace 112 is provided with a rounded corner 135 at the position where the barb 131 is connected, and the radius of the rounded corner 135 ranges from 0.02mm to 0.30mm, so that the excessive deformation of the root of the barb 131 caused by stress concentration generated by the load on the barb 131 during processing or after implantation can be avoided, and the risk of breaking the barb 131 can be reduced. In one embodiment, the radius of the fillet 135 is 0.03mm to 0.10mm, which can satisfy the fatigue resistance and strength of the barbs 131 and reduce the risk of fracture of the barbs 131 during the manufacturing process and after implantation. Specifically, the number of the barbs 131 is 6 to 18. In this embodiment, the number of the barbs 131 is 9, and the ends of the plurality of barbs 131 that are connected to the leaflet braces 112 are located at the same height of the leaflet braces 112.

Referring to FIG. 4, the length a of the barbs 131 is 2mm to 3mm, or 3mm to 5mm, or 5mm to 10mm. In the present application, the length a of the barb 131 refers to the length of a line between the end point of the end of the barb 131 connected to the leaflet brace 112 and the end point of the end of the barb 131 remote from the leaflet brace 112. Preferably, the length a of the barbs 131 is 3mm to 5mm, so that the barbs 131 cannot easily get loose after being hooked on the valve leaflet of the human body, and the barbs 131 cannot penetrate into the tissue to perforate or damage the blood vessel. The included angle A between the agnail 131 and the leaflet brace 112 is 20-45 degrees, or 45-60 degrees, or 60-70 degrees. Preferably, the included angle A between the barbs 131 and the leaflet braces 112 is 45-60 degrees, so that the barbs 131 can be more easily hooked on the leaflets of the human body without significantly affecting the sheathing force. The width of the barb 131 is 0.2 mm-1.0 mm, preferably, the width b of the barb 131 is 0.2 mm-0.4 mm, which can not affect the sheath feeding force of the heart valve and can also provide effective axial supporting force. In this embodiment, the barbs 131 are of uniform width (end not considered) design, and the width of the barbs 131 in this application is the width at a location excluding the ends. The thickness c of the barb 131 is the same as the whole thickness of the leaflet brace 112, 0.2 mm-0.6 mm, preferably, the thickness c is 0.3 mm-0.5 mm, can guarantee the strength of the barb 131, can also provide great axial holding power. The ratio of the width b to the thickness c of the barbs 131 ranges from 0.6 to 1, or from 1 to 1.2, or from 1.2 to 1.5, so that the amount of strain of the barbs 131 when bearing blood pressure load is small, and the strength and fatigue resistance of the barbs 131 are improved. Preferably, the ratio of the width b to the thickness c of the barbs 131 ranges from 0.6 to 1, and the barbs 131 have superior strength and fatigue resistance.

To prevent the barbs 131 from abrading the surrounding tissue, the ends of the barbs 131 may be passivated. For example, the ends of the barbs 131 may be spheroidized, such as by argon arc welding. As another example, the end of the barb 131 may be chamfered after being shaped or cut using a pattern with chamfers. Referring to fig. 5, the barb 131 includes a fixing portion 131a and a bending portion 131b, one end of the fixing portion 131a is connected to the leaflet brace 112, the other end is connected to the bending portion 131b, the bending portion 131b bends toward the longitudinal central axis of the leaflet brace 112, and an included angle between the bending portion 131b and the fixing portion 131a ranges from 110 ° to 160 °. Bend through the one end of keeping away from leaflet support 112 to barb 131, can be so that barb 131's end can not be with great angle direct contact ventricular wall, can reduce in very big degree with ventricular wall frictional resistance or ventricular wall's possibility, in addition, the barb blocks the probability of sheath pipe and scratch sheath pipe when reduction that can also be very big releases or retrieves. More specifically, the length of the bent portion 131b is 0.2 to 0.5 times the total length of the barb 131. The bent portion 131b may be formed by bending toward the inside of the leaflet brace 112 at the time of heat setting when processing.

Referring to fig. 2 and 3, the link 114 includes a proximal link 1141, a leaflet brace link 1142, and a joint 1143. The proximal link 1141 is generally rod-shaped. The leaflet support link 1142 is substantially V-shaped, and includes two branch rods extending from one end of the proximal end link 1141 to the leaflet support 112, one end of the two branch rods, which is far away from the proximal end link 1141, is fixedly connected with two troughs adjacent to the wave ring of the leaflet support 112, which is close to the outflow end, and each trough is connected with one branch rod, so that the plurality of links 114 are uniformly distributed along the outflow end, thereby playing a role in guiding when the heart valve 10 is received in the sheath tube, and preventing the troughs from being blocked outside the sheath tube. If the leaflet support links 1142 are attached to the leaflet support 112 at the peaks of the wave circle near the outflow end, the troughs tend to catch outside the sheath when the heart valve 10 is sheathed.

It is understood that the leaflet stent links 1142 can have other shapes as well, for example, can be in a straight shape extending from one end of the proximal links 1141 directly to connect with the valleys at the outflow end of the leaflet stent 112, i.e., the number of struts can correspond to the number of proximal links 1141.

In the present embodiment, referring to fig. 1 and 3, the leaflet holders 112, the connecting rods 114, the skirt holders 120 and the fixing members 130 are cut from the same tube and are integrally formed. The integrated cutting is performed in a split manner and then assembled, so that the valve stent 100 has the advantages of small radial size after compression and easiness in sheathing, and meanwhile, welding or splicing structures do not exist among all parts which are integrally formed, so that the fatigue resistance of the valve stent 100 is improved. In this embodiment, the valve stent 100 can be cut and shaped by using a superelastic nickel-titanium metal tube with a diameter of 6mm to 10mm and a wall thickness of 0.3mm to 0.5 mm.

The structures of the leaflet holders 112, the links 114, the skirt holders 120, and the fixing members 130 of the valve holder 110 in the present application are not limited thereto, and the valve holder 100 may be adjusted as needed.

Referring to fig. 1, 6 and 7, the joint 1143 of the connecting rod 114 is connected to the connecting member 116. The connecting piece 116 includes an insertion socket 1161 and a connecting cover 1163 fixedly connected to the insertion socket 1161, the connecting cover 1163 is provided with a limiting hole 1162, one end of the connecting rod 114 away from the leaflet bracket 112 penetrates through the limiting hole 1162 and is accommodated in a cavity formed by the connecting cover 1163 and the insertion socket 1161, and the tether 150 is detachably connected to the insertion socket 1161.

The connecting cover 1163 includes a connecting sleeve 1164 and a spherical cap 1166 formed at one end of the connecting sleeve 1164, one end of the connecting sleeve 1164 far from the spherical cap 1166 is fixedly sleeved with the socket 1161 to form a cavity, and the limiting hole 1162 is a strip-shaped hole extending axially along the connecting sleeve 1164. The number of the connecting rods 114 is plural, the number of the limiting holes 1162 is plural, the plurality of limiting holes 1162 are uniformly distributed along the circumferential direction of the connecting sleeve 1164, and the joint 1143 of each connecting rod 114 passes through one limiting hole 1162. The limiting hole 1162 extends from an end of the connecting sleeve 1164 away from the spherical cap 1166 to a middle portion of the spherical cap 1166, so that when the connecting rod 114 is connected to the connecting cover 1163, an angle of the connecting rod 114 can deflect within the limiting hole 1162 by a small angle, and when the heart valve 10 is in a compressed state and an uncompressed state, the connecting rod 114 can adapt to different states of the heart valve 10 through angle changes.

Referring to fig. 8, the socket 1161 is a hollow structure, a hanging rod 1165 is disposed in the socket 1161, and the tether 150 is slidably disposed on the hanging rod 1165, that is, one end of the tether 150 penetrates through the socket 1161 and far from the connection cover 1163, and passes through the hanging rod 1165 and then penetrates through the socket 1161 and far from the connection cover 1163. That is, the tether 150 is folded back at the hanging bar 1165 to form a structure in which two tethers 150 overlap each other, and pulling the tether 150 from one end of the tether 150 can make the other end of the tether 150 pass through the socket 1161, thereby releasing the tether 150 from the connecting member 116. Specifically, the socket 1161 includes a main body portion 1167 and an insertion portion 1168, an outer diameter of the main body portion 1167 is substantially the same as an outer diameter of the connecting sleeve 1164, the insertion portion 1168 is protruded from the main body portion 1167 and is smaller than the outer diameter of the main body portion 1167, the insertion portion 1168 is accommodated in the connecting sleeve 1164, and the two insertion portions can be fixed by welding or the like.

In this embodiment, the socket 1161 is further provided with an internal thread 1169 for connecting with the external thread 51 of the delivery cable 50, and the socket 1161 is connected with the delivery cable 50 by a thread. Attachment and detachment of the heart valve 10 from the delivery system may be accomplished by way of rotation. The delivery cable 50 can function to push or pull the heart valve 10 within the lumen of the delivery sheath when the heart valve 10 is delivered within the delivery sheath, and can also pull the heart valve 10 back into the delivery sheath again through the delivery cable 50 after the heart valve 10 is released from the delivery sheath.

In the present embodiment, the material of the tether 150 is selected from at least one of dacron, nylon, ultra-high molecular weight polyethylene, nickel titanium, and stainless steel.

The resistive elements 170 are configured to block blood flow from escaping through the valve stent 110, and cooperate with the leaflets 190 to ensure unidirectional blood flow within the heart valve 10. The choke piece 170 is made of PTFE, PET, PU, casing or animal pericardium. The choker 170 may be laminated by a heat pressing process or fixed to the valve holder 110 by sewing, depending on the material. In the present embodiment, the flow blocking element 170 covers the surfaces of the leaflet holders 112 and skirt holders 120. Specifically, the flow inhibitor 170 may cover only at least one of the inner surface and the outer surface of the leaflet braces 112. In one embodiment, to accelerate the cover 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.

The leaflets 190 are positioned inside the leaflet braces 112 and are secured to the flow resistance elements 170 on the surface of the leaflet braces 112. The leaflet 190 is cut from the animal pericardium. In the present embodiment, the leaflet 190 has a substantially fan shape, and three leaflets in total are arranged in this order in the circumferential direction of the leaflet brace 112. One ends of the adjacent two leaflets 190 near the inner surface of the leaflet support 112 are joined together to form a leaflet angle, the peripheries of the leaflets 190 are fixed to the leaflet support 112 and the flow blocking member 170 by sewing, and the leaflet angle is fixed to a position where the link 1123 is connected to the leaflet support 112.

Referring to fig. 9 and 10, the heart valve 10 may further include a spacer 180. The gasket 180 is made of at least one or a combination of silica gel, polyester, nylon, ultra-high molecular weight polyethylene, nickel titanium and stainless steel. The gasket 180 may be a felt-like disc, a titanium-nickel wire woven disc, a polymer injection molded disc, a stainless steel disc, or a combination thereof. The spacer 180 is provided with at least two through holes 181, and the diameter of the through holes 181 is not smaller than the diameter of the tether 150. After the heart valve 10 is implanted in the human heart 60, the two free ends 151 of the tether 150, which are away from the connecting rod 114, pass through the heart 60 and the two through holes 181 of the spacer 180, and then are tied with a plurality of knots to be fixed with the spacer 180 (fig. 10 shows the case of tying two knots). The perivalvular leakage condition of the heart valve 10 implanted in the heart 60 is diagnosed through the ultrasonic Doppler image in the operation process, if the perivalvular leakage exists, the tension of the tether 150 can be adjusted through the knotting process of the tether 150 and the gasket 180 or the length of the tether 150 between the gasket 180 and the connecting piece 116 is adjusted to improve the attaching force of the skirt support 120 of the heart valve 10 and the human mitral valve annulus 62 of the heart 60, so that the purpose of reducing the perivalvular leakage is achieved. Moreover, the end of the tether 150 away from the connecting element 116 has two free ends 151, so that the two free ends 151 can be tied together to tie a knot, thereby preventing the tether 150 from falling off the spacer 180 and improving the safety of the heart valve 10. Since the two sides of the tether 150 are connected by the hanging rod 1165 and the connecting member 116, the tether 150 can slide freely on the hanging rod 1165, so the tensions of the two sides of the tether 150 must be equal, the tension of the tether 150 can be uniformly dispersed on the two sides, and the tether 150 cannot be broken due to the excessive tension on one side caused by the unequal tensions of the two sides of the tether 150. Meanwhile, one end of the tether 150 is connected to the connecting element 116, thereby limiting the axial displacement of the end of the tether 150, so that when the two free ends 151 of the tether 150 are knotted through the two through holes 181 of the spacer 180 and a force is applied, the spacer 180 can be tightly attached to the surface of the heart toward the connecting element 116, thereby achieving a hemostatic effect.

It will be appreciated that in one embodiment, tether 150 may also be secured to link 116 at one end and have two free ends 151 extending from the other end. For example, a string may be attached to the middle of a string, or a string may be unwound from the middle to provide two free ends.

Referring to fig. 9 and 11, when the heart valve 10 is implanted in the heart 60, the skirt holder 120 of the heart valve 10 can fix the heart valve 10 on the mitral annulus 62, and the end of the tether 150 away from the connecting rod 114 is tied through the heart 60 and the spacer 180 and then fixed, so as to prevent the heart valve 10 from being displaced. During the operation, after it is determined by the push-pull test that the fixing element 130 is fixed to the heart tissue, for example, after it is ensured that the barbs 131 catch the leaflets of the human body and do not displace, the tether 150 may be detached from the valve stent 100 (as shown in fig. 11), so as to avoid the risk of thrombus caused by the tether 150 remaining in the left ventricle, and if during the operation, due to individual differences or operation deviations, the fixing element 130 may not be fixed to the heart tissue to fix the heart valve 10 in the heart 60, and at this time, the tether 150 may be retained, and the heart valve 10 is fixed by the tether 150 (as shown in fig. 9), so that the success rate of the operation may be increased, and the applicability of the heart valve 10 may also be increased.

Referring to fig. 11, the heart valve of the second embodiment of the present application is generally identical in construction to the heart valve 10 of the first embodiment of the present application, except that tether 250 is a rigid structure, and tether 250 is released from socket 2161 of connector 216 by a rotational operation. When the tether 250 is required for fixation, one end of the tether 250 may be extended out of the heart for fixation, and when it is determined that the tether 250 is not required for fixation, the tether 250 may be released from the heart valve by rotating the tether 250.

Referring also to fig. 12, tether 250 is threadably coupled to receptacle 2161. In the illustrated embodiment, the socket 2161 has internal threads on the inner wall of the socket 2168 and the tether 250 has external threads that mate with each other. In the present embodiment, the tether 250 is a metal wire structure, and the material may be selected from stainless steel, cobalt-titanium alloy, and the like.

Referring to fig. 13, the heart valve of the third embodiment of the present application has substantially the same structure as the heart valve 10 of the first embodiment, except that the tether 350 is a rigid structure, and the tether 350 is disengaged from the socket 3161 of the connector 316 by a rotational operation. When the tether 350 is required for fixation, one end of the tether 350 may be extended out of the heart for fixation, and when it is determined that the tether 350 is not required for fixation, the tether 350 may be disengaged from the heart valve by rotating the tether 350.

Referring to fig. 14, the tether 350 is provided with a recess 351, one end of the tether 350 near the recess 351 is fixedly connected to the plug 3161, and the recess 351 is broken by a rotation operation, that is, the tether 350 is broken at the recess 351 by the rotation operation, so that the tether 350 is disengaged from the plug 3161. Specifically, recessed portion 351 is received within receptacle 3161 or recessed portion 351 is flush with the end of receptacle 3161 so that tether 350 remaining within receptacle 3161 after breaking does not extend out of receptacle 3161. One end of the tether 350 near the recess 351 is fixedly connected to the plug 3168 by welding or gluing.

In this embodiment, the tether 350 may be made of metal wire or single strand polymer wire, and the material may be stainless steel, cobalt-chromium alloy, PP or PET.

All possible combinations of the technical features of the above embodiments may not be described for the sake of brevity, but should be considered as within the scope of the present disclosure 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 is characterized by comprising a valve support and a tether, wherein the valve support comprises a main body support, a skirt support and a fixing piece, the skirt support and the fixing piece are arranged on the main body support respectively, the main body support comprises a valve leaflet support, a connecting rod and a connecting piece, one end of the connecting rod is fixedly connected with one end of the valve leaflet support, the other end of the connecting rod is connected with the connecting piece, the connecting piece comprises a plug socket and a connecting cover fixedly connected with the plug socket, a limiting hole is formed in the connecting cover, one end, far away from the valve leaflet support, of the connecting rod penetrates through the limiting hole and is contained in a cavity formed by the connecting cover and the plug socket, and the tether is detachably connected with the plug socket.

2. The heart valve of claim 1, wherein the skirt stent and the retainer are disposed on the leaflet stent.

3. The heart valve of claim 1, wherein the socket is a hollow structure, a hanging rod is disposed in the socket, and one end of the tether penetrates through the socket from an end thereof away from the connection cover and passes through the hanging rod and then penetrates out from an end thereof away from the connection cover.

4. The heart valve of claim 1, wherein the tether is a rigid structure, the tether being releasable from the hub by a rotational operation.

5. The heart valve of claim 1, wherein the tether is threadably connected to the hub.

6. The heart valve of claim 4, wherein the tether is provided with a recess, and an end of the tether adjacent to the recess is fixedly connected to the socket, and the recess is broken by a rotation operation.

7. The heart valve as claimed in any one of claims 1 to 6, wherein the connection cap comprises a connection sleeve and a spherical cap formed at one end of the connection sleeve, which is far away from the spherical cap, is sleeved and fixed with the socket to form the cavity, and the limiting hole is formed in the connection sleeve.

8. The heart valve of claim 1, wherein the skirt stent extends radially outward from the body stent, the skirt stent being further from the tether than the retainer.

9. The heart valve of claim 8, wherein the retainer includes a plurality of barbs disposed around the body support, the barbs extending radially outward from the body support, an axial distance between an end of the barbs proximate the body support and an end of the skirt support proximate the body support ranging from 5mm to 16mm.

10. The utility model provides a heart valve, its characterized in that includes valve support, tether and gasket, valve support include the main part support and set up in shirt rim support on the main part support, the gasket is provided with two at least through-holes, the one end of tether with the main part support is connected, and the other end has two free ends, two the free end wears to locate respectively one of gasket behind the through-hole, it is fixed to knot each other to adjust the length or the tension of tether.

11. The heart valve of claim 10, wherein the main body frame includes a leaflet frame, a link rod, and a connector, the skirt frame is disposed on the leaflet frame, one end of the link rod is fixedly connected to one end of the leaflet frame, the other end of the link rod is connected to the connector, and one end of the tether, which is away from the spacer, is connected to the connector.

12. The heart valve of claim 11, wherein the connection element comprises an insertion seat and a connection cover fixedly connected to the insertion seat, the connection cover is provided with a limiting hole, one end of the connection rod away from the leaflet bracket penetrates through the limiting hole and is accommodated in a cavity formed by the connection cover and the insertion seat, and one end of the tether line away from the spacer is connected to the insertion seat.

13. The heart valve of claim 12, wherein the socket is a hollow structure, a hanging rod is disposed in the socket, and an end of the tether, which is away from the gasket, is slidably disposed on the hanging rod.