WO2021121292A1

WO2021121292A1 - Heart valve

Info

Publication number: WO2021121292A1
Application number: PCT/CN2020/136995
Authority: WO
Inventors: 潘湘斌; 刘香东
Original assignee: 先健科技(深圳)有限公司
Priority date: 2019-12-19
Filing date: 2020-12-16
Publication date: 2021-06-24
Also published as: CN212522083U

Abstract

A heart valve (100), comprising a valve stent (110), a flow blocking member (170), and a leaflet (190); the flow blocking member (170) and the leaflet (190) are provided on the valve stent (110); the flow blocking member (170) comprises a first flow blocking film (171) and a second flow blocking film (172); the first flow blocking film (171) is provided on an inner surface of the valve stent (110), or the first flow blocking film (171) is provided on an outer surface of the valve stent (110), or the first flow blocking film (171) is provided on the inner surface and the outer surface of the valve stent (110); the second flow blocking film (172) is provided on the outer surface of the valve stent (110) and is located on an outer surface of the first flow blocking film (171); the second flow blocking film (172) is provided, on a surface far from the first flow blocking film (171), with a viscous layer (1721) for slowing down the rate of blood flow; when paravalvular blood flow of the heart valve (100) encounters the viscous layer (1721), the viscous layer (1721) can have a viscous effect on the blood flow, the rate of blood flow decreases, and the blood flow experiences coagulation on the viscous layer (1721) after a period of time so as to form a thrombus to thereby completely fill a gap between a surface of the heart valve (100) and the heart tissue (65), thus blocking the paravalvular blood flow and having the effect of preventing a paravalvular leak.

Description

Heart valve

Technical field

The utility model relates to the field of medical equipment, in particular to a heart valve.

Background technique

Heart valve disease is a very common heart disease, among which valve damage caused by rheumatic fever is one of the most common causes. With the aging of the population, senile valvular disease and valvular disease caused by coronary heart disease and myocardial infarction are becoming more and more common. These valvular diseases not only endanger the safety of life and affect the quality of life, but also bring heavy burden and pressure to the family and society. The human heart is divided into four heart chambers: left atrium, left ventricle, right atrium, and right ventricle. The two atria are connected to two ventricles, and the two ventricles are connected to two large arteries. The heart valve grows between the atrium and the ventricle, 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 human body are called the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. If these valves are diseased, it will affect the movement of blood flow, which will cause abnormal heart function and eventually lead to heart failure.

In recent years, patients with mitral valve stenosis and regurgitation can also undergo percutaneous transsheathed mitral valve replacement surgery, that is, implanting heart valves through interventional and minimally invasive methods, so that patients can avoid surgery. The pain of chest surgery.

However, the existing heart valves still have some drawbacks and unreasonable places.

Utility model content

Based on this, it is necessary to provide a heart valve.

A heart valve, comprising a valve stent, a baffle and a valve leaflet, the baffle and the valve leaflet are arranged on the valve stent, and the baffle includes a first baffle film and a second baffle film , The first choke film is disposed on the inner surface of the valve stent, or the first choke film is disposed on the outer surface of the valve stent, or the first choke film is disposed on the The inner surface and outer surface of the valve stent; the second choke film is disposed on the outer surface of the valve stent, and is located on the outer surface of the first choke film, and the second choke film is far away from the first choke film. The surface of a baffle membrane is provided with a viscous layer for slowing down the flow velocity of blood flow.

For the above-mentioned heart valve, when the perivalvular blood flow encounters the viscous layer, the viscous layer can play a viscous effect on the blood flow, and the blood flow velocity slows down. After a period of time, the blood flow coagulates on the viscous layer and forms a thrombus. The gap between the surface of the heart valve and the heart tissue is filled, thereby blocking the paravalvular blood flow and preventing paravalvular leakage.

Description of the drawings

FIG. 1 is a schematic diagram of the structure of the heart valve according to the first embodiment of the application;

FIG. 2 is a schematic diagram of a part of the structure of the heart valve shown in FIG. 1;

Fig. 3 is a partial structural diagram of the valve stent of the heart valve of Fig. 1;

4 is a schematic diagram of the outline of the skirt stent of the heart valve of FIG. 1;

Fig. 5 is a schematic diagram of the structure of the elastic member shown in Fig. 1;

Fig. 6 is a schematic diagram of a part of the structure of the heart valve and the human mitral valve annulus shown in Fig. 1 (for clarity, part of the structure of the second choke film is omitted);

FIG. 7 is a schematic diagram of a partial planar deployment structure of the valve stent of the heart valve of FIG. 1;

Figure 8 is a partial cross-sectional view of the heart valve shown in Figure 1;

Fig. 9 is a partial structural diagram of the heart valve shown in Fig. 1 after being implanted into the heart;

Fig. 10 is a structural schematic diagram of the heart valve shown in Fig. 1 and the human mitral valve in one state;

Fig. 11 is a structural schematic diagram of the heart valve and human mitral valve shown in Fig. 1 in another state;

Fig. 12 is a schematic diagram of the structure of the heart valve shown in Fig. 1 after being implanted into the heart.

Detailed ways

In order to facilitate the understanding of the present utility model, the present utility model will be described in a more comprehensive manner with reference to the relevant drawings. The preferred embodiments of the present invention are shown in the drawings. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the understanding of the disclosure of the present utility model more thorough and comprehensive.

It should be noted that when an element is considered to be "connected" to another element, it may be directly connected to the other element or there may be a centered element at the same time. The terms "vertical", "horizontal", "left", "right", "upper", "lower", "far", "near" and similar expressions used herein are for illustrative purposes only.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field of the present invention. The terms used in the description of the present utility model herein are only for the purpose of describing specific embodiments, and are not intended to limit the present utility model. The term "and/or" as used herein includes any and all combinations of one or more related listed items.

It should be noted that in this application, the distal end refers to the end far away from the operator during the operation, and the proximal end refers to the end close to the operator during the operation.

Please refer to FIG. 1 at the same time. In this embodiment, a mitral valve stent is taken as an example to describe the structure of the heart valve 100. Of course, in other embodiments, the heart valve 100 is not limited to the mitral valve 100 shown in FIG. The valve stent can also be other types of artificial valve stents, such as pulmonary valve stents and aortic valve stents.

Please refer to FIGS. 1 and 17 at the same time. The heart valve 100 includes a valve stent 110, a connecting member 130, a tether 150, a baffle member 170, and a valve leaflet 190. The connecting member 130 is connected to the valve support 110, the tether 150 is connected to the connecting member 130, and the baffle member 170 and the valve leaflet 190 are disposed on the valve support 110.

Please refer to FIG. 2, the valve support 110 includes a leaf support 112, a skirt support 114, a connecting rod 116, and an elastic member 118. The valve stent 110 has an inflow end and an outflow end disposed opposite to the inflow end. The inflow end is the end where blood flows in when the valve leaflets are opened, that is, the distal end. The outflow end is the end where blood flows out when the valve leaflets are opened, that is, the proximal end.

The leaflet holder 112 is substantially cylindrical. Please also refer to FIG. 3, the leaflet support 112 includes a wave ring 1121 and a connecting rod 1123. The leaflet support 112 includes a plurality of wave rings 1121 spaced apart along the axial direction of the leaflet support 112. The wave ring 1121 provides the radial support force of the leaflet support 112. In the illustrated embodiment, the leaflet support 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 connecting rods 1123 is the same as the number of troughs of the wave ring 1121, and one connecting rod 1123 is fixedly connected to the troughs of the three wave rings 1121 at the same time. Of course, in other embodiments, the connecting rod 1123 may also be fixedly connected to other positions of the wave ring 1121, such as the wave crest.

3, the connecting rod 1123 is formed with a connecting post 11231 for fixing the leaflet 190, and the connecting post 11231 is located between the two wave circles 1121 near the outflow end. The connecting post 11231 is provided with a through hole. In this embodiment, there are three connecting posts 11231, and they are evenly distributed along the circumferential direction of the leaflet holder 112.

Please continue to refer to FIG. 2, the leaflet holder 112 is also provided with barbs 1125, the barbs 1125 extend radially outward from the leaflet holder 110, the end of the barbs 1125 close to the leaflet holder 112 and the skirt holder 114 are close to the valve The axial distance between the ends of the leaf holder 112 ranges from 5 mm to 16 mm. Preferably, the axial distance between the end of the barb 1125 near the leaflet support 112 and the end of the skirt support 114 near the leaflet support 112 ranges from 10 mm to 16 mm. Please also refer to FIG. 12, when the heart valve 100 is implanted in the human heart 60, the human body's own mitral valve leaflets will be squeezed toward the ventricular wall by the valve leaflet holder 112 and remain open. The skirt holder 114 of the heart valve 100 It can be stuck on the mitral valve annulus 62 to prevent the heart valve 100 from falling into the left ventricle, and the barbs 1125 provided on the valve leaflet stent 112 can hook the lower edge of the body's own valve leaflets. It can restrain the axial degree of freedom of the heart valve 100 and prevent the heart valve 100 from moving to the left atrium, effectively reducing the probability of heart valve displacement after implantation, and because the barb 1125 can be hung on the body's own valve leaflet without using Penetrating into the ventricular tissue can prevent the barb 1125 from rubbing against the ventricular tissue to damage the myocardial tissue around the ventricle and avoid the risk of puncturing the ventricular wall. At the same time, the barbs 1125 hang the body's own valve leaflets, which can allow the body's own valve leaflets to wrap the outside of the outflow end of the heart valve 100, thereby reducing the risk of paravalvular leakage. Of course, in other embodiments, the axial distance between the end of the barb 1125 close to the leaflet holder 112 and the end of the skirt stent 114 close to the leaflet holder 112 ranges from 5 mm to 10 mm, and the barb 1125 can also be pierced The human mitral valve leaflets are fixed.

Barb 1125 is cut. The cutting pattern of the barb 1125 is located at the end of the connecting rod 1123 of the leaflet holder 112 away from the inflow end, and the barb 1125 is broken out when the shape is finalized. Specifically, the connecting rod 1123 is cut to form a barb groove 1126, and the end of the barb 1125 away from the outflow end is broken out from the barb groove 1126 toward the radially outward of the leaflet holder 112 during shaping. When the heart valve 100 is received in the sheath, the barbs 1125 are received in the barb grooves 1126.

Please also refer to FIG. 3, the skirt support 114 includes a supporting portion 1141 and a raised portion 1143. The support portion 1141 extends outward from the leaflet support 112 along the radial direction of the leaflet support 112, and the upturned portion 1143 bends and extends from the end of the support portion 1141 away from the leaflet support 112 to the inflow end of the leaflet support 112. The supporting portion 1141 is used to fix the heart valve 100 on the mitral valve annulus 62 of the heart 60, and the raised portion 1143 is used to prevent the edge of the skirt stent 114 from abrading the left atrial tissue. If there is no uplifted portion 1143, the distal edge of the supporting portion 1141 directly contacts the atrial tissue, which will cause a cutting effect on the atrial tissue under long-term heart beats, resulting in damage to the atrial tissue. With the presence of the raised portion 1143, the contact between the skirt stent 114 and the atrial tissue becomes surface contact, which increases the contact area, reduces the contact pressure, and can avoid the cutting effect of the skirt stent 114 on the heart tissue, and The abrasion caused.

In the embodiment shown in FIG. 3, the supporting portion 1141 of the skirt bracket 114 is fixedly connected to the wave trough of the wave ring 1121 near the inflow end of the leaflet bracket 112. In this way, when the heart valve 100 is implanted into the heart 60, nearly one-third of the axial dimension of the leaflet stent 112 can be located in the left atrium, thereby avoiding excessive implantation of the left ventricle to cause stenosis or even obstruction of the left ventricular outflow tract.

In one of the embodiments, the width of the supporting portion 1141 of the skirt bracket 114 is 2 mm to 6 mm. Here, the width of the supporting portion 1141 refers to the distance between the end of the supporting portion 1141 close to the upturned portion 1143 and the leaflet holder 112. The width of the support portion 1141 is 2mm-6mm, which is approximately equal to the width from the inside of the mitral valve annulus of the human heart 60 to the atrial wall, that is, the radial width of the annulus, which can fully ensure that the heart valve 100 is in the mitral valve of the human heart. The fixation of the ring.

In one of the embodiments, the height of the raised portion 1143 is 2 mm to 6 mm. Here, the height of the raised portion 1143 refers to the distance between the end of the raised portion 1143 away from the support portion 1141 and the end close to the support portion 1141. The height of the raised portion 1143 is too low to prevent the edge of the skirt stent 114 from abrading the heart tissue, and it may damage other tissues of the left atrium if it is too high.

In this embodiment, the skirt support 114 includes a plurality of skirt sub-units, the skirt sub-units are approximately petal-shaped, and the multiple skirt sub-units are evenly distributed along the circumferential direction of the leaflet support 112. Each skirt subunit includes a supporting portion 1141 and a raised portion 1143.

Please refer to FIG. 4, the outline of the skirt stent 114 is generally circular when viewed from the inflow end of the valve blood flow, and the outer contour is generally circular. Here, it can also be considered that the outer contour of the orthographic projection of the skirt support 114 on a plane perpendicular to the axis of the leaflet support 112 is substantially circular. It should be noted that, in some embodiments, the orthographic projection of the skirt support 114 on the plane perpendicular to the axis of the leaflet support 112 may also be discontinuous. In this case, the outer contour refers to the fitting curve of the orthographic projection. The smooth curve obtained afterwards. In some embodiments, the skirt support 114 is covered with a spoiler, and the outer contour refers to the outer contour of the skirt support 114 covered with the spoiler in an orthographic projection of a plane perpendicular to the axis of the leaflet support 112 contour. It should also be noted that, in this application, roughly circular refers to the difference between the distance from each position on the outer contour to the center of the leaflet stent and the average distance from each position on the outer contour to the center of the leaflet stent The ratio of the average distance from each position on the outer contour to the center of the leaflet support is less than 10%, or less than 5%, or less than 3%, or less than 2%, or less than 1%.

The skirt support 114 includes a first area 1144 distributed in the circumferential direction and a second area 1145 connected to the first area 1144. The strength of the skirt support 114 in the first area 1144 is lower than that in the second area 1145. Preferably, the ratio of the intensity of the first region 1144 to the intensity of the second region 1145 ranges from 0.5 to 0.9. Specifically, the cross-sectional area of the rod in the first region 1144 is smaller than the cross-sectional area of the rod in the second region 1145. More specifically, the rod width of the first area 1144 is smaller than the rod width of the second area 1145. The rod width of the first region 1144 is 0.5 to 0.9 times the rod width of the second region 1145. During the operation, the first area 1144 is placed at the position of the annulus where the anterior mitral valve leaflets are aligned. Since the strength of the first area 1144 is relatively small, the position of the skirt stent 114 corresponding to the anterior mitral valve leaflet can be reduced. Compression of the aortic valve root reduces the risk of aortic valve dysfunction. If the skirt stent 114 is designed to be a D-shaped structure that matches the mitral valve annulus structure, although the skirt stent can theoretically reduce the compression of the aortic root corresponding to the position of the mitral valve anterior leaflet, it needs to be Accurate positioning during the operation, once the position deviation occurs, it is difficult to achieve the above effect, and may also cause paravalvular leakage. More specifically, the area covered by the first area 1144 in the circumferential direction of the leaflet stent 112 occupies 0.2-0.5 of the entire circumference of the leaflet stent 112, that is, the coverage angle of the first area 1144 in the circumferential direction of the leaflet stent 112 is 72° ～180°. If it is less than 0.2, it is difficult to reduce the compression on the aorta, if it is greater than 0.5, it may easily cause the skirt stent to pull off from the mitral valve annulus. In this embodiment, the area covered by the first area 1144 in the circumferential direction occupies 1/4 of the entire circumference. There are a total of 12 skirt sub-units on the skirt support 114, of which the strength of 3 skirt sub-units is weakened.

It should be noted that the strength of the skirt support 114 of the first region 1144 can also be weakened in other ways. For example, the first area 1144 is provided with slits, such as by laser cutting, to reduce the intensity of the first area 1144. Of course, in other embodiments, the position of the first area 1144 may not be provided with the skirt bracket 114. Alternatively, the density of the rods in the first area 1144 is less than the density of the rods in the second area 1145.

One end of the elastic member 118 is set on the leaflet support 112 and the other end is set on the skirt support 114. Please refer to FIG. 2, the elastic member 118 is disposed between the outflow end of the leaflet support 112 and the skirt support 114, and the elastic member 118 protrudes radially outward of the leaflet support 112. Specifically, the elastic member 118 includes a plurality of elastic wires arranged around the outer periphery of the leaflet stent 112, the elastic wires extend outward from the leaflet stent 112 in the radial direction of the leaflet stent, one end of the elastic wire is connected to the leaflet stent 112, and the other One end is connected with the skirt support 114. Please also refer to Figure 5, a plurality of elastic wires are connected to each other to form a wave-shaped ring, the wave-shaped ring includes a plurality of distal vertices 1181, a plurality of proximal vertices 1183 and connect adjacent distal vertices 1181 and the proximal end In the support body 1182 between the vertices 1183, a plurality of distal vertices 1181 are respectively connected to the skirt support 114, and a plurality of proximal vertices 1183 are respectively connected to the leaflet support 112. In the illustrated embodiment, a plurality of distal vertices 1181 are respectively fixedly connected to the end of the support portion 1141 away from the leaflet holder 112. The multiple proximal vertices 1183 are located on the same circumferential surface perpendicular to the longitudinal center axis of the leaflet stent 112, that is, the connection points between the multiple proximal vertices 1183 and the leaflet stent 112 have no height difference in the axial direction of the leaflet stent 112 .

In this embodiment, there are two proximal vertices 1183 between every two adjacent connecting rods 1123 of the leaflet holder 112. One proximal apex 1183 is fixed in the fixing hole 115 of the leaflet holder, and the other is close to The end vertex 1183 is fixed on the baffle 170 to improve the deformability of the elastic member. Specifically, the elastic member 118 includes two interlaced wave-shaped rings, each wave-shaped ring includes 12 distal vertices 1181, 12 proximal vertices 1183, and the distance between the distal vertices 1181 and the proximal vertices 1183 The supporting bodies 1182 cross each other to form a small closed structure to facilitate fixing with sutures.

The elastic wire can also be covered with a baffle film (not shown in the figure). Specifically, the baffle membrane covers all the elastic wires, forming a ring structure on the outer periphery of the leaflet holder 112. It should be noted that in other embodiments, the baffle film may also be a discontinuous structure. For example, the baffle film may only cover part of the elastic wires, or the baffle film may be broken between two adjacent elastic wires. The material of the baffle film is PET, PU, PA, PTFE, etc., and the material of the baffle film may be the same as or different from the material of the baffle 170. In this embodiment, the choke membrane is made of PTFE material and is fixed on the inner and outer surfaces of the elastic wire by hot pressing. Of course, in other embodiments, methods such as stitching can also be used. The two ends of the baffle film can be flush with the two ends of the elastic wire, can also extend beyond the two ends of the elastic wire, or the two ends of the elastic wire can also be exposed.

In this embodiment, the elastic wire is a nickel-titanium wire with a wire diameter of 0.002 to 0.006 inches (0.0508 to 0.1524 mm), which has good deformability and can fully fill the gap between the mitral valve annulus and the heart valve. To prevent paravalvular leakage.

Please refer to FIG. 6 together. After the heart valve 100 is implanted, the elastic member 118 is located at the position of the mitral valve annulus 62, as shown on the left side of FIG. 6, when the leaflet stent 112 or the skirt stent 114 is close to the mitral valve When the ring 62(a) is used, the elastic member 118 and the baffle on the elastic member will be recessed in the radial direction and/or in the direction toward the inflow end to adapt to the shape of the mitral valve annulus 62(a) and maintain its appearance It fits on the contact surface of the mitral valve annulus 62(a) to block blood flow and prevent paravalvular leakage. As shown on the right side of Figure 6, when the leaflet stent 112 or the skirt stent 114 and the mitral valve When there is a gap in the valve annulus 62(b), since the elastic member 118 together with the baffle on the elastic member protrudes in the radial direction of the leaflet stent 112 and/or toward the outflow end, it can fill the leaflet stent 112 and the mitral The gap between the valve annulus 62(b) to block blood flow and prevent paravalvular leakage.

Please refer to FIG. 3 again, the connecting rod 116 includes a proximal connecting rod 1162, a leaflet support connecting rod 1164, and a joint 1166. The proximal link 1162 is generally rod-shaped. The leaflet stent link 1164 is roughly V-shaped and includes two struts extending from one end of the proximal link 1162. The ends of the two struts far away from the proximal link 1162 are respectively connected to the wave ring of the leaflet stent 112 near the outflow end. The two adjacent troughs of 1121 are fixedly connected, and each trough is connected with a strut, so that multiple connecting rods 116 are evenly distributed along the outflow end, so as to play a guiding role when the heart valve 100 is retracted into the sheath to prevent trough jams Outside the sheath. If the leaflet stent link 1164 is connected to the wave crest of the leaflet stent 112 near the outflow end, when the heart valve 100 is sheathed, the wave trough will be stuck outside the sheath.

It is understandable that the leaflet stent link 1164 can also have other shapes, for example, it can be in a straight shape, extending from one end of the proximal link 1162 directly to connect with the trough at the outflow end of the leaflet stent, that is, the number of struts It is the same as the number of proximal links 1162.

The joint 1166 is formed at the end of the proximal link 1162 away from the leaflet support link 1164. In the illustrated embodiment, the joint 1166 is generally rod-shaped or trapezoidal, and extends perpendicular to the proximal link 1162.

In the illustrated embodiment, the leaflet support 112, the skirt support 114, and the connecting rod 116 are cut from the same pipe material, and are an integrally formed structure. A schematic diagram of the planar unfolded structure of the valve stent 110 obtained by integral cutting is shown in FIG. 7. Of course, it should be pointed out that the expanded view shown in FIG. 7 is that the valve stent 110 is still roughly tubular after being cut integrally with a tube, and is shaped into the shape shown in FIG. 3 after a heat treatment process. One-piece cutting is relative to split-cutting and then assembling. It has the advantages of small radial size after compression and easy sheathing. At the same time, each part of the valve stent 110 eliminates the welding or splicing structure, which also improves the fatigue resistance of the valve stent 110. In this embodiment, the valve stent 110 is cut from a superelastic nickel-titanium metal tube with a diameter of 6-10 mm and a wall thickness of 0.3-0.5 mm.

The joint 1166 of the connecting rod 116 of the valve stent 110 is connected to the connecting member 130. The connecting member 130 is provided with a threaded structure for connecting with the valve delivery system. One end of the tether 150 is connected to the connecting member 130, and the other end extends out of the heart and is fixed at the apex of the heart. The material of the tether 150 is selected from at least one of polyester, nylon, ultra-high molecular weight polyethylene, nickel titanium, and stainless steel.

Please refer to FIG. 8 again. FIG. 8 is a partial cross-sectional view of the heart valve 100. When the heart valve 100 is in an open state, the angle α of the connecting rod 116 is 40°-60°. The angle α of the connecting rod 116 refers to the angle between the connecting point of the connecting rod 116 and the leaflet support 112 and the connecting point of the connecting rod 116 and the connecting member 130 and the axis of the leaflet support 112. It should be noted that in the illustrated embodiment, the connecting rod 116 is linear, and the angle α of the connecting rod 116 is the angle between the connecting rod 116 and the axis of the leaflet holder 112. Preferably, the included angle α of the connecting rod 116 is 45°-60°.

The baffle 170 is disposed on the valve support 110. 1 and 2 together, the baffle 170 includes a first baffle 171 and a second baffle 172, the first baffle 171 is disposed on the inner surface of the valve stent 110, or the first baffle 171 is disposed on the inner surface of the valve stent 110, or the first choke film is disposed on the inner and outer surfaces of the valve stent 110, and the first choke film 171 is used to block blood flow from overflowing through the valve stent 110.

In one embodiment, the first spoiler film 171 extends from an end of the leaflet support 112 away from the connecting rod 116 along the inner surface of the leaflet support 112 to an end of the leaflet support 112 close to the connecting rod 116. Specifically, the first baffle film 171 is disposed on the inner surface of the leaflet holder 112, and the first baffle film 171 is a fiber cloth, such as a plain weave cloth. In other embodiments, the first baffle film 171 may also be a traditional film covering material such as PTFE, PET, PU, casing or animal core. For example, the first baffle film 171 is made of PTFE, and the first baffle film 171 is covered on the inner surface and the outer surface of the leaflet holder 112 by hot pressing.

The second choke film 172 is disposed on the outer surface of the valve stent 110 and is located on the outer surface of the first choke film 171. In the illustrated embodiment, the second baffle film 172 wraps the leaflet support 112, the skirt support 114, and the elastic member 118 from the outer surface of the end of the leaflet support 112 away from the connecting rod 116, and extends to the leaflet support 112 Close to one end of the connecting rod 116.

In one embodiment, the end of the second baffle film 172 away from the connecting rod 116 is stitched with the end of the first baffle film away from the connecting rod 116, and the end of the second baffle film 172 close to the connecting rod 116 is connected to the first baffle film. One end close to the connecting rod 116 is stitched.

The surface of the second baffle film 172 away from the first baffle film 171 is provided with a viscous layer 1721 for slowing down the blood flow velocity. When the valve leaflets are closed, the paravalvular blood flow flows to the left atrium through the gap between the surface of the heart valve 100 and the heart tissue 65. When the paravalvular blood flow encounters the viscous layer 1721, the viscous layer 1721 can affect the blood flow. Viscous effect slows down blood flow. After a period of time, blood flow coagulates on the viscous layer 1721 and forms thrombus, which fills the gap between the surface of the heart valve 10 and the heart tissue 65, thereby blocking the paravalvular blood flow. To prevent paravalvular leakage.

Specifically, the second baffle film 172 also includes a base cloth (not shown in the figure, hidden by the viscous layer), the viscous layer 1721 is disposed on the surface of the base cloth away from the first baffle film 171, the base cloth and the viscous layer 1721 It is a one-piece woven structure. The viscous layer 1721 is composed of a plurality of loop-shaped structures woven by fiber threads, and the plurality of loop-shaped structures form a fish-scale structure on the surface of the second baffle film 172 away from the first baffle film. When the paravalvular blood flow flows from the gap between the surface of the heart valve 100 and the heart tissue 65 to the left atrium, it will encounter the layer-by-layer obstruction of the loop-like structure on the second choke membrane 172, and at the same time, due to the larger loop-like structure The surface area can have a viscous effect on blood flow, slow down the blood flow speed, and make blood easy to coagulate around the ring-shaped structure to form thrombus, and the formed thrombus can fill the gap between the heart valve 100 and the heart tissue 65, thereby Can avoid the occurrence of paravalvular leakage. In one embodiment, the base fabric and the loop-like structure are integrally woven, and the loop-like structure is not easy to fall off from the base fabric 1722, which can avoid blood vessel blockage caused by this.

Further, the thickness of the second baffle layer 172 is 0.65 mm to 1.05 mm. The thickness of the base cloth is 1/3 to 2/3 of the thickness of the second blocking film 172. The unit weight of the second baffle film 172 is 135 g/m ² to 155 g/m ² . If the thickness of the second baffle membrane 172 is too large, and the unit weight is too large, it is easy to cause the compression diameter of the heart valve 10 to be large, and it is difficult to receive the sheath. However, if the thickness of the second baffle membrane 172 is too small and the unit weight is too small, it is easy to reduce its viscosity on blood flow, and the effect of reducing paravalvular leakage is not good. The length of each loop-like structure is 0.5mm～1.1mm, which can improve the blood viscosity while reducing the sheath size.

The second baffle film 172 is also a fiber cloth, such as knitted polyester cloth, and the fiber thread weaving density of the first baffle film 171 is greater than the fiber thread weaving density of the second baffle film 172, or the fibers of the first baffle film 171 The number of threads is greater than the number of fiber threads of the second choke membrane 172, which can make the first choke membrane 171 have better sealing performance and can block blood flow from overflowing through the valve stent 110. At the same time, the second choke membrane 172 The coefficient of friction is relatively large, which can increase the circumferential frictional resistance of the heart valve 100 and facilitate the fixation of the heart valve 100.

Referring to FIG. 1, the contour of the end of the baffle member 170 close to the outflow end of the leaflet holder 112 is the same as the contour of the outflow end of the leaflet holder 112. In the illustrated embodiment, the wave ring 1121 is located at the end of the leaflet holder close to the connecting rod 116, and is fixedly connected to the connecting rod 116. The contour of the outflow end of the leaflet holder 112, that is, the contour of the wave ring 1121 is sawtooth, blocking flow The contour of the end of the member 170 near the outflow end of the leaflet stent 112 is zigzag and is the same as the contour of the outflow end of the leaflet stent 112, and the end of the baffle member 170 near the outflow end of the leaflet stent 112 is sutured and fixed with the wave ring 1121 by suture .

Of course, in other embodiments, the outflow end of the leaflet holder 112 is not zigzag. At this time, the shape of the end of the baffle member 170 close to the outflow end of the leaflet holder 112 can be changed accordingly. As long as the two contours are the same, It can prevent the baffle 170 from protruding when it is received in the sheath, and it can also reduce the risk of obstruction of the left ventricular outflow tract after the heart valve 100 is implanted.

Please refer to FIGS. 1 and 2 again, the leaflet 190 is located inside the leaflet support 112 and is fixed to the baffle 170 on the inner surface of the leaflet support 112. Of course, in other embodiments, when the baffle 170 is not provided on the inner surface of the leaflet holder 112, the leaflet 190 can be directly fixed to the leaflet holder 112. The valve leaflet 190 is formed by laser cutting the bovine pericardium or pig pericardium fixed by glutaraldehyde. In the illustrated embodiment, the leaflet 190 is roughly fan-shaped, and there are three pieces in total, which are sequentially arranged along the circumferential direction of the leaflet holder 112. One ends of two adjacent leaflets 190 are attached to each other to form a valve angle 192, and the valve angle 192 is fixed on the valve support 110. In the illustrated embodiment, the valve angle 192 is fixed to the connecting post 11231, the lower edge of the valve leaflet 190 is fixed to the leaflet holder 112 and the baffle member 170 by suture, and the upper edge of the valve leaflet 190 faces the outflow end. Of course, in other embodiments, the leaflets 190 may also be two or four.

Refer to Figure 2, the skirt stent 114 is also provided with a positioning member 1147. The vertical line segment from the positioning member 1147 to the axis of the valve stent 110 and the vertical line segment from a valve angle 192 to the axis of the valve stent 110 are in a plane perpendicular to the axis of the valve stent 110 The projections on are coincident, and it can also be considered that the vertical section from any point on the centerline of one of the connecting posts 11231 parallel to the axial direction to the axis of the leaflet holder 112 is perpendicular to the vertical section from the positioning member 1147 to the axis of the leaflet holder 112. The projections on the plane of the axis of the leaflet holder 112 coincide. In this way, by observing the position of the positioning member 1147 in the heart, the adjustment of the position of the heart valve 100 in the heart can be facilitated, so that the valve angle 192 is located at the center of the anterior mitral valve leaflet. After the heart valve 100 is implanted in the heart 60, the diameter of the leaflet stent 112 is generally larger than the short diameter of the mitral valve annulus, and the leaflet stent 112 will be partially deformed under the radial action of the anterior and posterior mitral valve leaflets. The leaflet stent 112 is deformed from a circular shape to an irregular ellipse-like shape (the part close to the anterior mitral valve leaflet 62c has a larger radius of curvature, and the part close to the posterior mitral valve leaflet 62d has a smaller radius of curvature). 10, if one of the valve angles 192 is positioned at the center of the anterior mitral valve leaflet 62c, the other two valve angles 192 are close to the posterior mitral valve leaflet 62d, and the deformed leaflet stent 112 is close to the second leaflet. The curvature of the part of the posterior leaflet 62d of the cusp is small, so the distance between the two angles 192 close to the posterior mitral valve leaflet 62d increases less, causing the leaflet 190 between the two angles 192 to be pulled. The extension is small, and the area of the central cavity surrounded by the leaflet 190 is eventually increased, which can greatly reduce the central regurgitation. If one of the valve angles 192 is located at the posterior mitral leaflet 62d and the other two angles 192 are located at the anterior mitral leaflet 62c, please refer to Figure 11, because the deformed leaflet holder 112 is close to the anterior mitral leaflet The radius of curvature of the portion 62c is larger, so the distance between the two angles 192 of the anterior mitral valve leaflet 62c increases, which causes the leaflet 190 between the two angles 192 to be stretched. Larger, eventually resulting in a larger area of the central cavity surrounded by the valve leaflet 190, and a larger central reflux volume. By superimposing the projection of the perpendicular line from the positioning member to the axis of the valve stent and the perpendicular line from a valve angle to the axis of the valve stent on a plane perpendicular to the axis of the valve stent, one of the valves can be purposefully adjusted during the operation. The angle is positioned to the center of the anterior mitral valve leaflet, which greatly reduces central regurgitation.

Referring to FIG. 2, two auxiliary members 1148 are also provided on the skirt support 114. The two auxiliary members 1148 are symmetrically arranged on both sides of the positioning member 1147, that is, the two auxiliary members 1148 are about the positioning member 1147 and are perpendicular to the petals. The axis of the leaf holder 112 is linearly symmetrical. In this embodiment, the positioning member 1147 is disposed at the center of the first area 1144 of the skirt support 114, and the two auxiliary members 1148 are also located in the first area 1144, adjacent to the skirt subunit where the positioning member 1147 is located. On the two skirt sub-units. It should be noted that the auxiliary member 1148 may also be located on the second area 1145, and the distance between the auxiliary member 1148 and the positioning member 1147 can be adjusted, as long as the two auxiliary members 1148 are symmetrically arranged on both sides of the positioning member 1147.

By setting two symmetrical auxiliary parts 1148, it is convenient to adjust the X-ray emission angle of DSA (digital subtraction angiography) equipment. When the two symmetrically arranged auxiliary parts 1148 show coincidence under DSA, it can be judged that the DSA equipment X The emission direction of the rays is perpendicular to the maximum axial section of the heart valve 100, and at this time, the valve angle 192 corresponding to the positioning member 1147 is also located on this maximum axial section, which facilitates accurate positioning and is also beneficial to determine the position of each part of the heart valve 100 Location status, and its effect on heart tissue.

In this embodiment, the positioning member 1147 and the auxiliary member 1148 are formed by forming mounting holes (not shown in the figure) on the skirt support 114, and then inserting developing materials such as gold, platinum, or tantalum into the mounting holes. The shape of the positioning member 1147 and the auxiliary member 1148 may be a circle, a square, a polygon, or other shapes that are easily observed under X-rays, as long as the positioning member 1147 and the auxiliary member 1148 can be distinguished.

It can be understood that the positioning member 1147 and the auxiliary member 1148 are not limited to being provided on the skirt support 114, and may also be provided in other positions of the valve support 110. For example, it can be provided on the leaflet holder 112. It is also understandable that the positioning member 1147 and the auxiliary member 1148 can also be formed in other ways, for example, wrapping gold or platinum wires on the leaflet support 112, the skirt support 114, or the connecting rod 116.

In order to improve the position recognition of the positioning member 1147 and the auxiliary member 1148 when the heart valve 100 is connected to the delivery system, a first suture point (not shown) and a position corresponding to the positioning member 1147 and the auxiliary member 1148 are provided on the surface of the baffle member 170 and The second stitching point (not shown).

Please also refer to FIG. 12, the heart valve 100 may further include a gasket 160. The material of the gasket 160 is selected from at least one or a combination of silica gel, polyester, nylon, ultra-high molecular weight polyethylene, nickel titanium, and stainless steel. The gasket 160 may be a felt-shaped disc, a disc-shaped structure woven of titanium nickel wire, a disc-shaped structure injection-molded with a polymer material, a stainless steel disc, or a combination of the above. The gasket 160 is provided with a through hole, and the diameter of the through hole is not less than the diameter of the tether 150. After the heart valve 100 is implanted in the human heart 60, the end of the tether 150 away from the connecting rod 116 passes through the through holes of the heart 60 and the gasket 160, and is then fixed with the gasket after a plurality of knots are tied. During the operation, ultrasound Doppler imaging is used to diagnose the paravalvular leak after the heart valve 100 is implanted into the heart 60. If there is a paravalvular leak, the tether 150 can be adjusted through the knotting process of the tether 150 and the spacer 160 The size of the tension or the length of the tether 150 can be adjusted to improve the adhesion between the skirt support 114 of the heart valve 100 and the elastic member 118 and the human mitral valve annulus 62 of the heart 60 to achieve the purpose of reducing paravalvular leakage.

It should be particularly noted that the technical solutions of the foregoing embodiments can be combined and applied without contradicting each other, and all of them are understandable.

The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, all possible combinations of the various technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, All should be considered as the scope of this specification.

The above-mentioned embodiments only express a few implementation modes of the utility model, and the description is relatively specific and detailed, but it should not be understood as a limitation on the scope of the utility model patent. It should be pointed out that for those of ordinary skill in the art, without departing from the concept of the utility model, several modifications and improvements can be made, and these all fall within the protection scope of the utility model. Therefore, the scope of protection of the utility model patent should be subject to the appended claims.

Claims

A heart valve, comprising a valve stent, a baffle and a valve leaflet, the baffle and the valve leaflets are arranged in the valve stent, characterized in that the baffle comprises a first baffle membrane and a first baffle Two choke membrane, the first choke membrane is provided on the inner surface of the valve stent, or the first choke membrane is provided on the outer surface of the valve stent, or the first choke membrane Set on the inner surface and outer surface of the valve stent;

The second choke film is arranged on the outer surface of the valve stent, and is located on the outer surface of the first choke film, and the surface of the second choke film away from the first choke film is provided with A viscous layer that slows down the flow of blood.
The heart valve according to claim 1, wherein the viscous layer comprises a plurality of loop-shaped structures woven by fiber threads, and the plurality of loop-shaped structures are located far away from the second choke membrane. The surface of the first baffle film is evenly distributed and arranged to form a fish-scale structure.
The heart valve according to claim 1, wherein the second baffle film comprises a base cloth, and the viscous layer is disposed on a surface of the base cloth away from the first baffle film.
The heart valve according to claim 3, wherein the base fabric and the viscous layer are an integral woven structure.
The heart valve according to claim 3, wherein the thickness of the second baffle membrane is 0.65 mm to 1.05 mm.
The heart valve according to claim 5, wherein the thickness of the base cloth is 1/3 to 2/3 of the thickness of the second choke membrane.
The heart valve according to claim 1, wherein the unit weight of the second baffle membrane is 135 g/m 2 to 155 g/m 2 .
The heart valve according to claim 1, wherein the valve stent comprises a leaflet stent and a skirt stent arranged on the leaflet stent, and the skirt stent extends from the leaflet stent along the The leaflet stent extends radially outward, the first choke film is disposed on the leaflet stent, and the second choke film covers the outer surfaces of the leaflet stent and the skirt stent.
The heart valve according to claim 8, wherein the valve support further comprises an elastic member, one end of the elastic member is arranged on the leaflet support, and the other end is arranged on the skirt support. The second baffle film covers the elastic member.
The heart valve according to claim 1, wherein the first choke membrane and the second choke membrane are both fiber cloth, and the fiber thread weaving density of the first choke membrane is greater than that of the The weaving density of the fiber threads of the second baffle film, or the number of fiber threads of the first baffle film is greater than the number of fiber threads of the second baffle film.