CN212395136U - Self-expanding atrioventricular valve prosthesis device - Google Patents

Abstract

The utility model discloses a self-expanding atrioventricular valve false body device, include: the main body part is of a frame structure and is implanted at the native valve annulus of the heart, the main body part comprises an inflow section, an outflow section and a transition section, the inflow section is positioned at the atrium end, the outflow section is positioned at the ventricle end, and the transition section is positioned between the inflow section and the outflow section; the artificial valve comprises a main body part and at least one artificial valve leaflet, wherein the main body part is provided with a transition section; and the chordae tendineae part is fixed at one end and connected with the artificial valve leaflet through the connecting part at the other end. The utility model discloses a tendon portion restricts the home range of artifical valve leaflet to and connecting portion prevent that tendon portion from tearing and stress concentration to the valve leaflet, thereby increase artifical valve leaflet's durability.

Description

Self-expanding atrioventricular valve prosthesis device

Technical Field

The utility model relates to the technical field of medical equipment, concretely relates to implant self-expanding atrioventricular valve false body device in the heart for replace native valve.

Background

The heart contains four chambers, the Right Atrium (RA), the Right Ventricle (RV), the Left Atrium (LA), and the Left Ventricle (LV). The pumping action on the left and right sides of the heart generally occurs simultaneously throughout the cardiac cycle. The valve that separates the atrium from the ventricle is called the atrioventricular valve, which acts as a one-way valve to ensure the normal flow of blood in the heart chamber. The atrioventricular valve between the left atrium and the left ventricle is the mitral valve, and the atrioventricular valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary arteries and from there to the lungs; the blood returns to the left atrium through the pulmonary veins. The aortic valve directs blood flow through the aorta and from there to the periphery. There is usually no direct connection between the ventricles or between the atria.

At the beginning of ventricular filling (diastole), the aortic and pulmonary valves close to prevent regurgitation from the arteries into the ventricles. Shortly thereafter, the atrioventricular valves open to allow unimpeded flow from the atria into the respective ventricles. Shortly after the onset of ventricular systole (i.e., ventricular emptying), the tricuspid and mitral valves normally close, forming a seal that prevents backflow from the ventricles into the respective atria.

When problems occur with the atrioventricular valve, it fails to function properly, resulting in improper closure. Atrioventricular valves are complex structures that typically include an annulus, leaflets, chordae tendineae, and a support structure. Each atrium is connected to its valve by the atrial vestibule. The mitral valve has two leaflets, a similar structure of the tricuspid valve has three leaflets, and attachment or engagement of the respective surfaces of each leaflet to one another helps provide closure or sealing of the valve, thereby preventing blood flow in the wrong direction. Failure of the leaflets to seal during ventricular systole is known as mal-coaptation and can reverse blood flow (regurgitation) through the valve. Cardiac valve insufficiency can have serious consequences for a patient, often leading to heart failure, reduced blood flow, reduced blood pressure, and/or reduced oxygen flow to human tissues. Mitral insufficiency may also cause blood to flow from the left atrium back into the pulmonary veins, causing congestion. Severe valvular insufficiency, if left untreated, can lead to permanent disability or death.

In recent years, there have been some breakthrough advances in the field of prosthetic valves, but due to the complexity of the mitral valve and its surrounding structures, mitral valve treatment still faces significant challenges, e.g., 1, how to solve the problem of leaflet prolapse and eversion: when the heart contracts after the artificial valve prosthesis is implanted, the valve leaflets have the risk of prolapse and eversion due to excessive ventricular pressure. 2. How to reduce leaflet stress and increase the durability of the artificial valve. The tricuspid valve also suffers from the problems described above.

SUMMERY OF THE UTILITY MODEL

The utility model provides a self-expanding atrioventricular valve prosthesis device, which can solve the defects in the prior art.

The technical scheme of the utility model as follows:

a self-expanding atrioventricular valve prosthesis device comprising: a body portion in a frame configuration implanted at a native annulus of the heart, the body portion including an inflow section at an atrial end, an outflow section at a ventricular end, and a transition section between the inflow section and the outflow section; at least one artificial valve leaflet fixed on the transition section of the main body part, wherein the artificial valve leaflet is provided with a connecting part; at least one chordae tendineae, one end of the chordae tendineae is fixed, the other end of the chordae tendineae is connected with the artificial valve leaflet through the connecting part, the chordae tendineae are used for limiting the moving range of the artificial valve leaflet and increasing the durability of the artificial valve leaflet.

When the heart contracts, because ventricular pressure is too big, artificial valve leaf has the risk of prolapse or valgus, the utility model discloses from reducing artificial valve leaf stress, increasing the leaflet durability and starting, through setting up a chordae tendineae portion and connecting the leaflet, when artificial valve leaf is about to the prolapse or valgus, chordae tendineae portion produce a pulling force to the leaflet, make the leaflet resume to the form that normally closes to make the leaflet can be normal under the closed condition close blood passage, the chordae tendineae portion of here plays the effect of chordae tendineae promptly. Considering that the leaflet is damaged over time due to tearing force and stress concentration when the chordae tendineae are directly connected with the leaflet, the leaflet is provided with a connecting part, so that the chordae tendineae are indirectly connected with the leaflet through the connecting part, and acting force generated by the chordae tendineae is applied to the leaflet through the connecting part, thereby reducing the stress of the leaflet and improving the durability of the leaflet.

In some embodiments, the connecting portion is disposed on a leaf surface of the artificial leaflet on a side close to the ventricular end, and the connecting portion disposed on the leaf surface can increase a contact area with the leaflet, thereby reducing stress concentration. In some embodiments, the connection portion is disposed at an edge of the prosthetic leaflet, the connection portion at the edge of the leaflet reducing the force applied by the chordae tendineae and thereby reducing stress. In some embodiments, the connection portion is disposed in a plurality, and the connection portion is disposed on a surface of the leaflet and at an edge of the leaflet, and the number of the connection portion may be set according to an actual clinical requirement.

In some embodiments, the artificial leaflet comprises a plurality of free edges, and the arc length of the connecting portion and any one of the connecting portions of the free edges occupies 1/12-1/3 of the arc length of the free edge. The longer the arc length of the connecting portion with the free edge, the smaller the range of motion of the leaflet, the too small range of motion, can influence the effective opening area of the leaflet, otherwise, the shorter the arc length of the connecting portion with the free edge, can increase the risk of friction between the leaflet and the main body portion.

In some embodiments, the connecting portion and the artificial leaflet are configured to have a predetermined angle α therebetween, wherein 0< α ≦ 180 °. Under the angle, the connecting part can not interfere the normal opening and closing of the artificial valve leaf and can not block the outflow channel.

In some embodiments, the chordae portion includes a first connection end and a second connection end, the first connection end being connected to the connection portion and the second connection end being secured to the body portion or the second connection end being secured to native tissue. When the chordae portion is connected to the main body portion, the connecting portion, the chordae portion and the main body portion may be integrally implanted, thereby simplifying the delivery system design. When chordae tendineae portion links to each other with the tissue, both can avoid the jam of connecting portion and chordae tendineae portion convection current outflow channel, simultaneously, compare in connecting portion and chordae tendineae portion and link to each other, design angle alpha can be bigger, therefore the configuration of the contained angle between connecting portion and the leaflet blade surface is also more nimble.

In some embodiments, the second connection end is fixed to the inflow section or the outflow section. Preferably, the second connecting end is fixed to the outflow section to prevent entanglement between the chordae portion and the main body portion, since the distance between the outflow section and the connecting portion is small, thereby reducing the material used for the chordae portion.

In some embodiments, the second attachment end is fixed to the superior or inferior tissue, preferably the inferior tissue.

In some embodiments, the second connecting end of the chordae portion is configured to have the same shape as the corresponding connecting portion when the second connecting end is connected to tissue. When the shape of the second connecting end connected with the tissue is the same as that of the connecting part, the tendon part and the connecting part can be stressed uniformly, and the durability of the tendon part and the connecting part is guaranteed to a certain extent.

In some embodiments, the chordae tendineae are configured to be in-line with the connecting portion when the prosthetic leaflet is in the closed state. At this time, the acting force of the chordae tendineae on the connecting portion is minimized, thereby enhancing the durability of the connecting portion.

In some embodiments, a connection hole is further formed near the center of the connection part, and the tendon part is connected with the connection part through the connection hole, so that the connection between the tendon part and the connection part is simpler.

Further, in some embodiments, a protective layer is coated on the circumferential direction of the connecting hole to buffer the tensile force of the tendon cable part on the connecting part.

In some embodiments, the self-expanding atrioventricular valve prosthetic device further comprises at least one attachment clip. The clamping piece can be connected with the part to be connected through at least one of sewing, rivet connection, inlaying and the like, and sewing is preferred.

In some embodiments, when the number of the artificial leaflets is at least two, the clamping member is clamped on the artificial leaflets for connecting two adjacent artificial leaflets, so as to reduce the range of motion of the artificial leaflets, thereby avoiding friction between the movable artificial leaflets and the main body portion and improving the durability of the artificial leaflets. After the movable range of the artificial valve leaf is reduced, correspondingly, the movable ranges of the connecting part and the chordae tendineae part are also limited, and the durability of the chordae tendineae part and the connecting part is further improved.

In some embodiments, the connecting portion is optionally integrally formed with the artificial leaflet and/or the chordae tendineae, e.g., the connecting portion is integrally formed with the artificial leaflet and then connected to the chordae tendineae, or the connecting portion is integrally formed with the chordae tendineae and then connected to the artificial leaflet; or the artificial valve leaflet, the connecting part and the chordae tendineae part are integrally prepared. Wherein, chordae tendineae can be the shaping to linear structure, sheet structure, and chordae tendineae can also be the shaping to helical structure to provide certain elasticity.

In some embodiments, the artificial leaflet, the connecting portion, and the chordae tendineae are separately prepared and re-connected. The molding modes of the artificial valve leaflet, the connecting part and the chordae tendineae can be selected according to actual clinical requirements.

Compared with the prior art, the beneficial effects of the utility model are as follows:

1. the atrioventricular valve prosthesis device of the utility model limits the motion range of the valve leaflet by using the chordae tendineae part to connect the artificial valve leaflet, thereby preventing the artificial valve leaflet from prolapsing or turning up; furthermore, the connecting part is added on the valve leaflet, so that the artificial valve leaflet is prevented from being directly connected with the chordae tendineae, the tearing force and the stress on the valve leaflet are relieved, and the durability of the valve leaflet is improved; additionally, the utility model discloses a chordae tendineae portion can restrict the home range of leaflet, prevents the collision of leaflet and main part, increases the durability of leaflet.

2. The utility model discloses an atrioventricular valve false body device is through setting up connecting portion and free limit coupling part's arc length to and realize being connected between two adjacent valve leaflets through the holder, can further restrict the home range of valve leaflet, avoid valve leaflet and main part collision, reduce the range of motion of connecting portion simultaneously, further reduce the range of motion of chordae tendineae portion, thereby increased the durability of chordae tendineae portion.

Drawings

FIG. 1 is a schematic view of the atrioventricular valve prosthesis device of the present invention after implantation;

fig. 2 is a schematic structural view of the main body of the present invention;

fig. 3 is a schematic structural view of an artificial leaflet according to embodiment 1 of the present invention;

fig. 4 is a schematic structural view of another artificial leaflet according to embodiment 1 of the present invention;

fig. 5 is a partial schematic structural view of an atrioventricular valve prosthesis device according to embodiment 1 of the present invention;

fig. 6 is a partial schematic structural view of another atrioventricular valve prosthesis device according to embodiment 1 of the present invention;

fig. 7 is a partial structural view of the artificial leaflet of embodiment 1 of the present invention in an open state;

fig. 8 is a partial structural view of the artificial leaflet of embodiment 1 of the present invention in a closed state;

fig. 9 is a partial schematic view of another atrioventricular valve prosthesis device according to embodiment 1 of the present invention;

fig. 10 is a partial schematic view of an atrioventricular valve prosthesis device according to example 2 of the present invention;

fig. 11 is another partial structural view of an atrioventricular valve prosthesis device according to embodiment 2 of the present invention;

fig. 12 is a partial schematic view of an atrioventricular valve prosthesis device according to embodiment 3 of the present invention;

fig. 13 is a partial schematic view of another atrioventricular valve prosthesis device according to embodiment 3 of the present invention;

fig. 14 is a schematic perspective view of a holder according to embodiment 4 of the present invention;

fig. 15 is a schematic structural view of the artificial leaflet of embodiment 4 of the present invention connected by sewing;

fig. 16 is a schematic structural view of the artificial leaflet and the holding member according to embodiment 4 of the present invention.

Reference numerals: an atrioventricular valve prosthesis device 100; a first region 101; a second region 102; a third region 103; a main body portion 110; an artificial leaflet 130; a connecting portion 140; chordae tendineae 150; an inflow section 111; a transition section 112; and an outflow section 113.

Detailed Description

The utility model provides a self-expanding atrioventricular valve prosthesis device, including main part, artificial valve leaf and chordae tendineae portion for replace the native valve of pathological change, play the effect of opening or closing blood passage. The atrioventricular valve prosthesis device can be designed as a mitral valve prosthesis for replacing a diseased mitral valve, and can also be designed as a tricuspid valve prosthesis for replacing a diseased tricuspid valve. The following will describe the present invention by taking the mitral valve as an example.

As shown in fig. 1, the atrioventricular valve prosthesis device 100 is a mitral valve prosthesis, and is longitudinally divisible into a first region 101, a second region 102, and a third region 103. After the mitral valve prosthesis is implanted into a human body, the first region 101 is attached to the native mitral valve annulus of the heart to prevent the prosthetic valve from falling into the left ventricle from the left atrium, and the second region 102 is used for bearing the artificial valve leaflet 130 and is supported on tissue by the anchoring force of the main body part to play roles of anchoring and sealing. As an alternative, the mitral valve prosthesis may replace only the anterior or posterior leaflet of the mitral valve, i.e., half of the prosthetic valve prosthesis is used in conjunction with half of the native leaflets.

Corresponding to the valve prosthesis, see fig. 2, the body portion 110 is divided into an inflow section 111, a transition section 112 and an outflow section 113, which can provide several functions for the valve prosthesis, including serving as a body structure, an anchoring structure (containing fluke structures to capture or puncture leaflets, etc.), a support that carries the inner prosthetic leaflet 130, the connecting portion 140 and the chordae portion 150, serving as a seal to inhibit paravalvular leakage between the valve prosthesis and the native valve, a connecting structure (a tab or a fixation ear 114) with the delivery system, and so forth.

The main body 110 is a frame structure with mesh holes and is woven or cut from a metal material, and if the valve prosthesis is implanted through a catheter, the main body 110 is made of nitinol or other biocompatible materials with shape memory, or may be an elastically or plastically deformable material, such as a balloon expandable material. The body portion 110 is capable of self-expanding to a predetermined configuration after implantation, thereby anchoring at the native valve annulus.

The prosthetic leaflets 130 dynamically switch between an open and a closed state in which the prosthetic leaflets 130 coapt or meet in sealing abutment, which may be the same number or a different number than the native leaflets. Prosthetic leaflet 130 can be formed of any suitable material or combination of materials, and can be selected from biological tissue such as chemically stabilized tissue from a heart valve of an animal (e.g., porcine), or pericardial tissue of an animal such as bovine (bovine pericardium) or ovine (ovine pericardium) or porcine (porcine pericardium) or equine pericardium, and can also be made of small intestine submucosal tissue. In addition, synthetic materials such as expanded polytetrafluoroethylene or polyester may also be selected. Optionally, thermoplastic polycarbonate polyurethane, polyether polyurethane, segmented polyether polyurethane, silicone-polycarbonate polyurethane, and ultra-high molecular weight polyethylene are also included. Also included are biocompatible polymers, optionally including polyolefins, elastomers, polyethylene glycols, polyethersulfones, polysulfones, polyvinylpyrrolidones, polyvinyl chlorides, other fluoropolymers, silicone polyesters, silicone polymers and/or oligomers, and/or polylactones, and block copolymers using the same. Optionally, leaflets 130 have surfaces treated with (or reacted with) anticoagulant, including but not limited to heparinized polymers.

The present invention can restrict the range of motion of the artificial leaflet 130 by the force applied to the leaflet 130 by the chordae tendineae 150, thereby preventing the artificial leaflet 130 from everting or prolapsing.

In the description of the present invention, it should be noted that "leaflet" and "artificial leaflet" have the same meaning. The term "atrial end" refers to the end near the atrium, and "ventricular end" refers to the end near the ventricle.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood in specific cases to those skilled in the art.

As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

The present invention will be further described with reference to the following specific examples.

Example 1

The present embodiment provides a self-expanding atrioventricular valve prosthetic device, which, referring to fig. 1-9, comprises a body portion 110, at least one artificial leaflet 130, and chordae tendineae 150. Wherein the main body portion is a frame structure and is implanted at a native annulus of a heart, the main body portion comprises an inflow section at an atrial end, an outflow section at a ventricular end, and a transition section between the inflow section and the outflow section; the artificial leaflet 130 is fixed at the transition section of the main body, a connecting part 140 is arranged at the proximal edge of the artificial leaflet 130, one end of the chordae tendineae is fixed, and the other end of the chordae tendineae is connected with the artificial leaflet 130 through the connecting part 140, so as to limit the moving range of the artificial leaflet 130 and increase the durability of the artificial leaflet 130.

When the heart contracts, because the pressure in the ventricle is too high, the artificial leaflet 130 risks prolapse or eversion, and in this embodiment, since the stress of the artificial leaflet 130 is reduced and the durability of the leaflet 130 is increased, by providing a chordae tendineae connected to the leaflet 130, when the artificial leaflet 130 is about to prolapse or evert, the chordae tendineae generate a pulling force on the leaflet 130, so that the leaflet 130 returns to a normally closed shape, and the leaflet 130 can normally close the blood passage in a closed state. That is, in the present embodiment, the chordae part 150 functions as a chordae. Considering that the leaflet 130 is damaged over time due to tearing force and stress concentration applied to the leaflet 130 when the chordae portion 150 is directly connected to the leaflet 130, the embodiment provides a connecting portion 140 on the leaflet 130, so that the chordae portion 150 is indirectly connected to the leaflet 130 through the connecting portion 140, and the force generated by the chordae portion 150 is applied to the leaflet 130 through the connecting portion 140, thereby reducing the stress of the leaflet 130 and increasing the durability of the leaflet 130.

Specifically, the connecting portions 140 may be disposed at the edge of the artificial leaflet 130, referring to fig. 3, the artificial leaflet has a fixing edge 134 fixed to the main body 110 by the fixing edge 134, the number of the connecting portions 140 is one, the connecting portions 140 are disposed at the edge of the leaflet, and the connecting portions 140 at the edge of the leaflet are disposed in three, so that the force applied by the chordae tendineae can be reduced by the connecting portions 140 at the edge of the leaflet, thereby reducing the stress. Of course, the connection part 140 may be disposed on the surface of the artificial leaflet 130, and as shown in fig. 5, the contact area between the connection part 140 and the leaflet 130 can be increased and the stress concentration can be reduced by disposing on the surface of the leaflet; the connection portion 140 is preferably disposed on the side surface close to the ventricular end. Alternatively, the connecting portions 140 may be disposed at the edge and on the surface of the artificial leaflet 130, as shown in fig. 6, in this case, the number of the connecting portions 140 is plural, and each connecting portion 140 is connected to one chordae tendineae portion 150.

The artificial leaflet 130 comprises a plurality of free edges, and the connecting part 140 can be positioned at any position of any free edge, wherein the arc length of the connecting part 140 and the connecting part of any free edge occupies 1/12-1/3 of the arc length of the free edge. The longer the arc length of the connecting portion 140 connecting the free edge, the smaller the range of motion of the leaflet 130, which is too small, and may affect the effective opening area of the leaflet 130, whereas the shorter the arc length of the connecting portion 140 connecting the free edge, may increase the risk of friction between the leaflet 130 and the main body portion 110.

In particular, with continued reference to fig. 6, the prosthetic leaflet 130 in this embodiment includes first, second and third free edges 131, 132, 133 and a fixed edge 134, the fixed edge 134 being secured to the transition section 112 of the main body portion 110; the third free edge 133 is located between the first free edge 131 and the second free edge 132, and the first free edge 131, the second free edge 132, and the third free edge 133 together constitute an edge of the artificial leaflet 130. The first free edge 131 is provided with a first connecting portion 141, the second free edge 132 is provided with a second connecting portion 142, the third free edge 133 is provided with a third connecting portion 143, and the surface of the artificial leaflet 130 is provided with a fourth connecting portion 144.

The third connecting portion 143 is preferably located at the center of the third free edge 133, and the force applied to the left and right sides of the third connecting portion 140 by the chordae tendineae is uniform at diastole, thereby improving the durability of the third connecting portion 143; meanwhile, the third connecting portion 143 prevents the artificial leaflet 130 from prolapsing or everting when the heart contracts. Of course, in other alternative embodiments, the connecting portions 140 may be located on any one, two or three of the first free edge 131, the second free edge 132, the third free edge 133 and the leaflet surface of the leaflet 130, and the number and the arrangement positions of the connecting portions 140 should be selected according to the actual clinical requirement, which is not limited herein.

Referring to fig. 7 and 8, there are shown partial structural views of the artificial leaflet 130, the connecting portion 140, the chordae tendineae 150, and the main body portion 110, respectively. In this embodiment, the connection portion 140 and the artificial leaflet 130 are disposed to have a predetermined angle α, where 0< α ≦ 180 °, and at this angle, the connection portion 140 does not interfere with the normal opening and closing of the artificial leaflet 130 and does not block the outflow tract. The artificial leaflet 130 shown in fig. 7 is in an open state, and the artificial leaflet 130 shown in fig. 8 is in a closed state.

The shape of the connecting portion 140 may be at least one of a triangle, a quadrangle, a pentagon, a quasi-circle, and a shape with a smooth contour, the quadrangle includes a square, a rectangle, a diamond, a trapezoid, etc., the quasi-circle is a regular polygon with a number of sides not less than six, and the shape with a smooth contour includes a circle, an oval, a semicircle, a semi-oval, a petal shape, etc. The present embodiment preferably has a rounded profile, and referring to fig. 3 to 6, the connecting portion 140 is semicircular, which is more favorable for stress dispersion.

Further, with continued reference to fig. 6-8, the tendon portion 150 includes a first connection end D1 and a second connection end D2, the first connection end D1 is connected to the connection portion 140, and the second connection end D2 is fixed to the body portion 110, such that when the tendon portion 150 is connected to the body portion 110, the connection portion 140, the tendon portion 150, and the body portion 110 can be implanted integrally, thereby simplifying the delivery system design.

In this embodiment, the first connection portion 141 is connected to the first tendon portion 151, the second connection portion 142 is connected to the second tendon portion 152, the third connection portion 143 is connected to the third tendon portion 153, and the fourth connection portion 143 is connected to the fourth tendon portion 154. Wherein, the first tendon portion 151, the second tendon portion 152, the third tendon portion 153, and the fourth tendon portion 154 are respectively fixed at predetermined positions of the outflow section 113. Of course, in other alternative embodiments, the first tendon portion 151, the second tendon portion 152, the third tendon portion 153, and the fourth tendon portion 154 may each be independently fixed to the inflow segment 111. When the tendon portions 150 are secured to the inflow section 111, the second connection ends D2 of the tendon portions 150 extend from the mesh of the frame structure or from the outflow section 113 to the inflow section 111 and are secured. Compared with the fixation at the inflow section 111, the distance between the connecting part 140 and the outflow section 113 is smaller, so the material consumption can be reduced; on the other hand, the attachment portion 140 is directly fixed to the outflow section 113 to prevent entanglement between the chordae portion 150 and the body frame structure.

Further, referring to fig. 9, the connecting side of the two tendon portions 150 and the main body portion 110 may be in the shape of a bridge, an umbrella, a cone, or the like, and preferably, the shape of the cone. The second connecting end D2 of the cord portion 150 is preferably wrapped around the body portion 110, so that the force applied to the cord portion 150 during systole is evenly distributed to the body portion 110, thereby ensuring durability of the cord portion 150.

In a preferred embodiment, the chordae portion 150 is configured to be aligned with the connection portion 140 when the prosthetic leaflet 130 is in the closed state, as shown in fig. 7 and 8, and the force of the chordae portion 150 on the connection portion 140 is minimized, thereby enhancing the durability of the connection portion 140.

Further, the connection part 140 may be integrally formed with the artificial leaflet 130 and then connected to the chordae tendineae 150, or the connection part 140 may be integrally formed with the chordae tendineae 150 and then connected to the artificial leaflet 130, or the artificial leaflet 130, the connection part 140 and the chordae tendineae 150 may be integrally formed. Of course, the artificial leaflet 130, the connecting portion 140 and the chordae tendineae 150 may be prepared separately and then assembled, but the assembly method includes, but is not limited to, sewing, gluing, riveting, inlaying, clip-fixing, etc. The shaping and connection modes of the artificial leaflet 130, the connection part 140 and the chordae tendineae 150 can be selected according to actual needs, and are not described herein again.

In this embodiment, the materials of the artificial leaflet 130, the connecting portion 140, and the chordae tendineae 150 may be the same or different. Preferably, the tendon portions 150 are formed into a linear structure or a sheet structure by selecting a material having a certain flexibility; or the chordae portion 150 may be shaped into a rigid structure, such as a spiral, to provide tension when the leaflet 130 is everted or prolapsed. The materials of the artificial leaflet 130, the connecting portion 140 and the chordae tendineae 150 are not intended to limit the scope of the present invention, and may be selected according to actual clinical needs.

Specifically, the material of the connecting portion 140 and the chordae tendineae 150 may be selected from biological tissue, synthetic material or biocompatible polymer, wherein the biological tissue is chemically stable tissue from a heart valve of an animal (such as pig), or pericardial tissue of an animal, such as bovine (bovine pericardium) or ovine (ovine pericardium) or porcine (porcine pericardium) or equine pericardium, or small intestine submucosal tissue; synthetic materials such as expanded polytetrafluoroethylene or polyester, optionally also including thermoplastic polycarbonate polyurethane, polyether polyurethane, segmented polyether polyurethane, silicone-polycarbonate polyurethane, and ultra high molecular weight polyethylene; biocompatible polymers optionally include polyolefins, elastomers, polyethylene glycols, polyethersulfones, polysulfones, polyvinylpyrrolidones, polyvinyl chlorides, other fluoropolymers, silicone polyesters, silicone polymers and/or oligomers, and/or polylactones, and block copolymers using the same.

Example 2

This embodiment provides a self-expanding atrioventricular valve prosthetic device, see fig. 10 and 11, which is similar in structure to that of embodiment 1, except that the second attachment ends D2 of the chordae tendineae 150 in this embodiment are fixed to the native tissue.

The native tissue comprises two parts, the tissue at the atrial end referred to as the superior tissue and the tissue at the ventricular end referred to as the inferior tissue, including but not limited to the papillary muscles, apex, ventricular septum, etc. When the chordae portion 150 is attached to the tissue 170, clogging of the outflow tract by the connecting portion 140 and the chordae portion 150 is avoided, while the design angle α is larger than if the connecting portion 140 were attached to the main body portion.

In this embodiment, the second connecting end D2 of the tendon portion 150 is preferably secured to the lower tissue 172 to prevent the second connecting end D2 from tangling with the body portion 110 as it passes through the frame.

When the heart contracts, in order to ensure the durability of the chordae tendineae 150, the force applied to the chordae tendineae 150 needs to be uniformly distributed on the tissue 170, but the area of the second connecting end D2 between the chordae tendineae 150 and the tissue 170 is too large, which is liable to interfere with the outflow tract of blood and affect the blood flow dynamics, and the area is too small, so that the force applied to the chordae tendineae 150 and the connecting part 140 is correspondingly increased. Therefore, it is preferable that the second connection end D2 of the tendon portion 150 has the same shape as the corresponding connection portion 140. When the second connection end D2 connected to the tissue 170 is the same shape as the connection part 140, the tendon portion 150 and the connection part 140 can be uniformly stressed, and the durability of the tendon portion 150 and the connection part 140 is ensured to some extent.

Example 3

This embodiment provides a self-expanding atrioventricular valve prosthesis device, which is an improvement over embodiment 1 or 2, wherein the connecting portion 140 is further provided with a connecting hole Q, see fig. 12, and the chordae tendineae 150 are connected to the connecting portion 140 through the connecting hole Q. The connection hole Q may be located at any position of the connection part 140, preferably, at the center of the connection part 140, so that the stress is uniformly dispersed. The number of the connection holes Q is at least 1, and the shape may be a rectangle, a circle, a triangle, etc., and a circle is preferable because the circle allows the tensile force applied to the connection part 140 to be uniformly distributed on the connection part 140 and the tendon part 150.

Further, a protective layer P is coated on the circumferential direction of the connection hole Q, see fig. 13, where the protective layer P may be a circle of metal sheet, PTFE membrane, dacron, and other materials with good biocompatibility, which are wrapped on the circumferential direction of the connection hole Q. The protective layer P serves to absorb the tensile force of the chordae part 150 to the connection part 140 when the artificial leaflet 130 moves, so as to increase the durability of the connection part 140.

Example 4

This example provides a self-expanding atrioventricular valve prosthesis device, modified from example 1, example 2 or example 3, wherein said atrioventricular valve prosthesis device further comprises at least one connecting clip 160, as shown in fig. 14 and 16.

The clamping member 160 may be attached to the portion to be connected by at least one of sewing, riveting, inlaying, and the like, preferably sewing. For example, the clip 160 may enable connection of the connection portion 140 to the prosthetic leaflet 130, and may enable connection of the connection portion 140 to the chordae tendineae 150.

In one embodiment, when the number of the artificial leaflet 130 is set to at least two pieces, the artificial leaflet 130 is clamped by the clamping member 160 to connect the adjacent two pieces of the artificial leaflet 130, so as to reduce the movable range of the artificial leaflet 130.

Specifically, the clamping member 160 is a clip, wherein the clip includes a leaflet sewing portion 162 and a main body sewing portion 161, the width of the clip is d, the free edge portions of two adjacent artificial leaflets are clamped by the clip, the clip is fixed to the leaflet 130 through the leaflet sewing portion 162, and the clip is fixed to the main body 110 through the main body sewing portion 161, so as to fix the artificial leaflet 130.

Fig. 15 shows the connection between the artificial leaflets 130 by sewing, L1 is the distance from the sewing point to the closed point O of the artificial leaflets, fig. 16 shows the connection between the artificial leaflets 130 by clip sewing, and L2 is the distance from the end of the clip remote from the main body part to the closed point O of the artificial leaflets. Wherein L1 is L2+ d, i.e., L1> L2, so the range of motion of the artificial leaflet 130 of fig. 16 is smaller than the amplitude of motion of the artificial leaflet 130 of fig. 15. After the artificial valve leaflet 130 is sewn through the clamping piece, the moving range is reduced, so that the friction between the movable artificial valve leaflet 130 and the main body part is avoided, and the durability of the artificial valve leaflet 130 is improved. After the movable range of the artificial leaflet 130 is reduced, the movable ranges of the connecting portion 140 and the chordae tendineae 150 are correspondingly limited, and the durability of the chordae tendineae 150 and the connecting portion 140 is further improved.

The material of the clamping member 160 may be at least one of metals, pericardium, PTFE, and other materials with good biocompatibility.

The above disclosure is only illustrative of the preferred embodiments of the present invention. The preferred embodiments are not intended to be exhaustive or to limit the invention to the precise embodiments disclosed, and it should be understood that these embodiments are merely illustrative of the invention and are not intended to limit the scope of the invention.

In practical applications, the improvement and adjustment made by those skilled in the art according to the present invention still belong to the protection scope of the present invention. Obviously, many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, to thereby enable others skilled in the art to best utilize the invention. The present invention is limited only by the claims and their full scope and equivalents.

Claims (14)

1. A self-expanding atrioventricular valve prosthesis device, comprising:

a body portion in a frame configuration implanted at a native annulus of the heart, the body portion including an inflow section at an atrial end, an outflow section at a ventricular end, and a transition section between the inflow section and the outflow section;

at least one artificial valve leaflet fixed on the transition section of the main body part, and provided with at least one connecting part;

at least one chordae part, one end of the chordae part is fixed, and the other end is connected with the artificial valve leaflet through the connecting part; the chordae tendineae are used for limiting the moving range of the artificial valve leaflet and increasing the durability of the artificial valve leaflet.

2. The self-expanding atrioventricular valve prosthetic device as claimed in claim 1, wherein the connecting portion is disposed on a leaf surface of the artificial leaflet or the connecting portion is disposed at an edge of the artificial leaflet.

3. The self-expanding atrioventricular valve prosthetic device as claimed in claim 1, wherein said artificial leaflet comprises a plurality of free edges, and the arc length of said connecting portion and any of said connecting portions of said free edges occupies 1/12-1/3 of the arc length of said free edge.

4. The self-expanding atrioventricular valve prosthesis device as recited in claim 1, wherein said connecting portion and said artificial leaflet are arranged to have a predetermined angle α, wherein 0< α ≦ 180 °.

5. The self-expanding atrioventricular valve prosthetic device of claim 1, wherein the chordae tendineae comprise a first connection end and a second connection end, the first connection end being connected to the connection portion and the second connection end being secured to the main body portion or the second connection end being secured to native tissue.

6. The self-expanding atrioventricular valve prosthetic device according to claim 5, wherein said second connecting end is fixed to said inflow section or said outflow section.

7. The self-expanding atrioventricular valve prosthetic device of claim 5, wherein said second attachment end is fixed to the superior or inferior tissue.

8. The self-expanding atrioventricular valve prosthetic device according to claim 5, wherein said second connecting ends of said chordae tendineae are configured to have the same shape as the corresponding connecting portions when said second connecting ends are connected to tissue.

9. The self-expanding atrioventricular valve prosthetic device according to claim 1, wherein the chordae tendineae are configured to be in alignment with the connecting portion when the prosthetic leaflet is in the closed state.

10. The self-expanding atrioventricular valve prosthetic device according to any one of claims 1-9, further comprising a connecting hole at a position near the center of said connecting portion, through which said chordae portion is connected to said connecting portion.

11. The self-expanding atrioventricular valve prosthesis device as recited in claim 10, wherein said attachment holes are circumferentially covered with a protective layer to cushion tension on said attachment portions by chordae tendineae.

12. The self-expanding atrioventricular valve prosthetic device of any one of claims 1-9 or 11, further comprising at least one attachment clip.

13. The self-expanding atrioventricular valve prosthesis device as claimed in claim 12, wherein said holding member is provided on said artificial leaflet so as to connect adjacent two of said artificial leaflets to reduce a movable range of said artificial leaflet when said artificial leaflet is disposed in at least two of said plurality of said artificial leaflets.

14. The self-expanding atrioventricular valve prosthetic device according to any one of claims 1-9 or 11, 13, wherein the connecting portion is optionally formed integrally with the artificial leaflet and/or the chordae tendineae, or wherein the artificial leaflet, the connecting portion and the chordae tendineae are separately formed and re-connected.

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