CN114533344A - Valve stent and prosthetic valve assembly - Google Patents

Abstract

The invention discloses a valve stent and a prosthetic valve assembly, the valve stent comprising: the support main part, including the inflow end, the end of flowing out and be located the portion of narrowing between the inflow end and the end of flowing out, the portion of narrowing includes the connecting rod of a plurality of connections inflow end and the end of flowing out, a plurality of connecting rods are at the circumference of support main part upward clearance distribution, the portion of narrowing has the flexibility, the end of flowing out has the diameter of fixed action and the end of flowing out end is not less than the diameter of the head end of the inflow end, the portion of narrowing is not more than the diameter of the head end of the inflow end at the diameter of the narrowest department along the radial direction of support main part. Through the mode, the bending capacity of the valve stent can be improved.

Description

Valve stent and prosthetic valve assembly

Technical Field

The invention relates to the technical field of medical equipment, in particular to a valve stent and a prosthetic valve assembly.

Background

At present, in order to facilitate the compression of the valve stent, the stent main body structure is basically set to be a diamond-shaped mesh structure, and after the stent with the diamond-shaped mesh structure is compressed, the size of the stent is still larger in the length direction or the diameter direction. The curvature of the implantation path of the valve stent is large, and if the length of the compressed valve stent is too long, the compliance of a delivery system in the delivery process can be seriously influenced, and the delivery difficulty is increased.

Disclosure of Invention

The invention mainly solves the technical problem of providing a valve stent and a prosthetic valve assembly, which can improve the bending capacity of the valve stent.

In order to solve the technical problems, the invention adopts a technical scheme that: providing a valve stent comprising: the support main part, including the inflow end, the portion of narrowing between inflow end and the outflow end and being located the inflow end, the portion of narrowing includes the connecting rod of a plurality of connections inflow end and outflow end, a plurality of connecting rods are at the circumference of support main part upper gap distribution, the portion of narrowing has the flexibility, the end diameter that the outflow end has fixed action and outflow end is not less than the diameter of the head end of inflow end, the portion of narrowing is not more than the diameter of the head end of inflow end at the diameter of the narrowest department along the radial direction of support main part.

Wherein the sum of the axial lengths of the outflow end and the narrowing is not greater than the axial length of the inflow end.

Wherein the axial length of the outflow end is not less than the axial length of the narrowing portion.

Wherein the outflow end varies in radial dimension in an axial direction along the stent body.

Wherein, the tail end of the outflow end and/or the head end of the inflow end are/is arranged in a non-radial manner, so that the tail end of the outflow end and/or the head end of the inflow end are/is in a smooth shape.

Wherein, valve support still includes anchor portion, and anchor portion sets up in the outflow end of support main part.

Wherein, the anchoring part comprises a bulge part which is protruded towards the direction far away from the axial direction of the bracket main body.

Wherein, the outflow end is provided with a skirt part.

Wherein the skirt portion is continuously or discontinuously disposed at the outflow end.

In order to solve the technical problem, the invention adopts another technical scheme that: a prosthetic valve assembly is provided, which comprises the valve support and a prosthetic valve arranged on the valve support.

The beneficial effects of the invention are: in contrast to the state of the art, the present invention provides a valve stent comprising: the support main part, including the inflow end, the end of flowing out and be located the portion of narrowing between the inflow end and the end of flowing out, the portion of narrowing includes the connecting rod of a plurality of connections inflow end and the end of flowing out, a plurality of connecting rods are at the circumference of support main part upward clearance distribution, the portion of narrowing has the flexibility, the end of flowing out has the diameter of fixed action and the end of flowing out end is not less than the diameter of the head end of the inflow end, the portion of narrowing is not more than the diameter of the head end of the inflow end at the diameter of the narrowest department along the radial direction of support main part. The diameter of the tail end of the outflow end is not smaller than that of the head end of the inflow end, so that on one hand, the radial acting force generated by the outflow end and facing the ascending aorta area is larger, and the outflow end is used as a main anchoring force source; on the other hand, the valve stent conforms to the physiological anatomical structure of a human body, can reduce the compression on the aorta, and prevents perivalvular leakage.

In addition, the arrangement of the connecting rod on the narrowing part increases the area of the mesh structure of the narrowing part on one hand, and is more beneficial to subsequent coronary intervention treatment; on the other hand, the connecting rod separates the inflow end and the outflow end of the valve stent, namely the connecting rod divides the valve stent into two parts, so that the narrowing part has flexibility, namely the valve stent has better bending capability, when the valve stent is loaded in a conveying system and is subjected to bow crossing, the valve stent can be divided into two parts to be bent and bow crossing, and the bow crossing capability of the whole conveying system is improved. The narrowing part has flexibility, so that the valve support can be adaptively deformed to enable the inflow end and the outflow end to be not coaxial under the condition that the ascending aorta area and the aortic valve annulus are not coaxial after the valve support is implanted into a body.

Drawings

FIG. 1 is a front view of a first valve stent provided by the present invention;

FIG. 2 is a schematic top view of a first valve stent provided in accordance with the present invention;

FIG. 3 is a schematic axial side view of a first valve stent provided in accordance with the present invention;

FIG. 4 is a schematic illustration of the anchoring of a first valve support in an anatomical structure provided by the present invention;

FIG. 5 is a partial schematic structural view of a first valve stent provided in accordance with the present invention;

FIG. 6 is a schematic front view of a second valve stent provided by the present invention;

FIG. 7 is a schematic top view of a second valve stent provided in accordance with the present invention;

FIG. 8 is a schematic side view of a second valve stent provided in accordance with the present invention;

FIG. 9 is a schematic illustration of the anchoring of a second valve support in an anatomical structure provided by the present invention;

fig. 10 is a partial structural schematic view of a second valve stent provided by the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments of the present invention without making any creative effort, shall fall within the protection scope of the present invention.

It should be noted that if the description of "first", "second", etc. is provided in the embodiment of the present invention, the description of "first", "second", etc. is only for descriptive purposes and is not to be construed as indicating or implying relative importance or implicitly indicating the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In addition, technical solutions between various embodiments may be combined with each other, but must be realized by a person skilled in the art, and when the technical solutions are contradictory or cannot be realized, such a combination of technical solutions should be considered to be absent and not be within the protection scope of the present invention.

In the present invention, "outer" refers to a direction away from the axial direction of the stent body, and "inner" refers to a direction closer to the axial direction of the stent body. The direction "up" refers to the direction of the stent body near the outflow end, and the direction "down" refers to the direction of the stent body near the inflow end. The "head end" refers to an end portion close to the inflow end of the stent body, and the "tail end" refers to an end portion close to the outflow end of the stent body.

In order to make the objects, technical solutions and effects of the present invention clearer and clearer, the present invention is further described in detail below with reference to the accompanying drawings and examples.

Referring to fig. 1-2, fig. 1 is a schematic front view of a first valve stent provided in the present invention, and fig. 2 is a schematic top view of the first valve stent provided in the present invention. The present invention provides a valve stent 100, the valve stent 100 being configured to support a prosthetic valve 200 and being considered as a frame structure supporting the prosthetic valve 200, the prosthetic valve 200 supported by the valve stent 100 being fixed relative to native heart tissue such that the prosthetic valve 200 is capable of assisting in the repair and/or replacement of the function of a defective heart valve.

Optionally, the valve stent 100 is a multi-layer mesh structure distributed along the axial direction thereof, for example, the valve stent 100 may be a double-layer, three-layer, four-layer, or other mesh structure, wherein the number of layers of the mesh structure of the valve stent 100 is not particularly limited, and may be specifically set according to the requirements on the strength, thickness, and the like of the valve stent 100.

Optionally, the valve stent 100 may be formed by laser cutting one or more tubes, wherein the tubes may be metal tubes or tubes made of polymer materials, and are not limited herein. In a specific embodiment, the valve stent 100 is cut from a tube of a nickel titanium superelastic alloy having shape memory characteristics such that the valve stent 100 can be made to self-expand from a compressed state, i.e., the valve stent 100 made using the shape memory metal is more readily self-expandable from a collapsed or constrained structural state to an expanded or in use structural state. In addition, the nickel-titanium super-elastic alloy can be subjected to heat treatment, polishing and other processing treatments, so that the manufactured valve stent 100 has better strength and certain glossiness. In other embodiments, the valve stent 100 may also be made of a wire, such as a shape memory metal wire, which may be specifically configured according to the actual application scenario and is not specifically limited herein.

Referring to fig. 1-3, fig. 3 is a schematic axial side view of a first valve stent provided by the present invention, in which a stent main body 10 includes an inflow end 11, an outflow end 13, and a narrowing portion 12 located between the inflow end 11 and the outflow end 13, and a diameter of the narrowing portion 12 at a narrowest position along a radial direction of the stent main body 10 is not greater than a diameter of a head end of the inflow end 11. The narrowing 12 has a sparse mesh structure 181 with continuous upper mesh and lower slit openings to prevent coronary occlusion and facilitate PCI coronary intervention after implantation of the valve stent 100.

Wherein the narrowing portion 12 includes a plurality of connecting rods 19 connecting the inflow end 11 and the outflow end 13, and the plurality of connecting rods 19 are circumferentially spaced apart. The arrangement of the connecting rod 19, on one hand, increases the area of the mesh structure 181 of the narrowing part 12, and is more beneficial to subsequent coronary intervention treatment; on the other hand, the connecting rod 19 separates the inflow end 11 and the outflow end 13 of the valve stent 100, that is, the connecting rod 19 divides the valve stent 100 into two parts, so that the valve stent 100 has better bending capability, when the valve stent 100 is loaded in a delivery system and subjected to bowing, the valve stent 100 can be divided into two parts to be bent and subjected to bowing, and the bowing passing capability of the whole delivery system is improved; furthermore, as shown in fig. 4, fig. 4 is a schematic view of anchoring the first valve stent in the anatomical structure provided by the present invention, and the connecting rod 19 also has a certain axial force-conducting capability, for example, when the prosthetic valve 200 is opened and closed, the pressure generated by the blood flow on the valve stent 100 is relatively large, the anchoring force between the inflow end 11 and the aortic annulus 20 is relatively small, and the inflow end 11 may be brought into the ventricle along with the blood flow, so that at this time, a certain axial force-conducting capability is required for the connecting rod 19 to transmit the force to the inflow end 11, which is equivalent to that the connecting rod 19 exerts a force to pull the inflow end 11, so as to prevent the inflow end 11 from slipping into the ventricle away from the outflow end 13 along with the blood flow, and ensure that the position between the inflow end 11 and the native heart tissue does not change. In this embodiment, the constriction 12 is flexible such that, when the valve stent 100 is implanted in the body, the upstream aortic region 30 and the aortic annulus 20 are not coaxial, the valve stent 100 can be adapted to deform such that the inflow end 11 and the outflow end 13 are not coaxial.

In one embodiment, the number of the connecting rods 19 may be 3-26, and the plurality of connecting rods 19 may be uniformly distributed along the circumferential gap, preferably, the number of the connecting rods 19 is 6 or 24, when the number of the connecting rods 19 is 6 and the uniform gap is distributed, the narrowing portion 12 of the valve stent 100 can have a mesh structure 181 with a larger area, which is beneficial for coronary intervention, and when the number of the connecting rods 19 is 24 and the uniform gap is distributed, the valve stent 100 can have better circumferential retraction capability. The number of the connecting rods 19 arranged in the gap at the narrowing portion 12 of the valve stent 100 can be set according to actual use requirements, and is not limited specifically herein.

In one embodiment, as shown in fig. 5, fig. 5 is a partial structural view of the first valve stent provided by the present invention, and the connecting rod 19 may also be a curved rod, for example, the connecting rod 19 is a serpentine rod or the like. In other embodiments, as shown in fig. 6 to 9, fig. 6 is a front structural view of the second valve stent provided by the present invention, fig. 7 is a top structural view of the second valve stent provided by the present invention, fig. 8 is a side structural view of the second valve stent provided by the present invention, fig. 9 is an anchoring view of the second valve stent provided by the present invention in an anatomical structure, and the connecting rod 19 may be a straight rod. The shape and configuration of the connecting rod 19 may be specifically set according to an actual use scenario, and is not particularly limited herein.

Alternatively, the connecting rod 19 may be integrally formed with the inflow end 11 and the outflow end 13. Specifically, as shown in fig. 5 and 10, fig. 10 is a partial structural schematic view of a second valve stent provided by the present invention, the inflow end 11 reduces the number of wave bars 113 extending along the axial direction of the stent main body 10 in the circumferential extending direction of the stent main body 10, forms a flap-hanging closed loop structure 115, continues to extend along the axial direction of the stent main body 10 to form a connecting bar 19, and finally extends along the axial direction of the stent main body 10 to form an outflow end 13. It is understood that in other embodiments, the connecting rod 19 may be connected with the inflow end 11 and the outflow end 13 by sewing, welding or riveting, and is not limited thereto.

Wherein the distance from the inflow end 11 to the connecting rod 19, i.e. the distance from the inflow end 11 to the narrowing 12, is greater than the distance from the aortic annulus 20 to the aortic sinus. Alternatively, the aortic annulus 20 may be spaced from the aortic sinus by a distance of 11mm to 16mm, which is not particularly limited.

With continued reference to fig. 4, in an embodiment, the inflow end 11 and the outflow end 13 of the stent body 10 have a continuous double-layer or multi-layer closed-loop mesh structure, which can increase the metal coverage of the inflow end 11 and the outflow end 13, thereby effectively increasing the radial stiffness of the inflow end 11 and the outflow end 13, further increasing the radial acting force of the inflow end 11 toward the aortic annulus 20 and increasing the radial acting force, i.e., the anchoring force, generated by the outflow end 13 toward the ascending aortic region 30, so that the anchoring effect of the valve stent 100 and the ascending aortic region 30 is more stable, and the relative position between the valve stent 100 and the native heart tissue is not changed.

The inflow end 11 is propped against the aortic valve annulus 20, so that the stent main body 10 is more attached to native heart tissue, and perivalvular leakage is prevented; close contact between the outflow end 13 and the ascending aorta region 30 secures the valve stent 100 in the ascending aorta region 30. When the valve stent 100 is released by catheter delivery into the heart, the stent body 10 tends to return to the original structural configuration due to the memory effect, and at this time, the outflow end 13 of the stent body 10 generates a radial force toward the ascending aortic region 30, and the inflow end 11 generates a radial force toward the aortic annulus 20, that is, the stent body 10 generates anchoring forces to the ascending aortic region 30 and the aortic annulus 20 to anchor and connect the valve stent 100 and the native heart tissue, so as to ensure that the relative positions of the valve stent 100 and the native heart tissue are not changed, and thus the prosthetic valve 200 disposed in the valve stent 100 can help repair and/or replace the function of the defective heart valve.

When the valve stent 100 is used for treating aortic regurgitation diseases, the native valve leaflets of a regurgitation patient and the aortic root are not always accompanied by serious calcification and are flexible to a certain extent, so that the anchoring force of the inflow end 11 is insufficient, and the valve stent 100 is easy to flow out of the ventricle and move. Therefore, the present disclosure provides a valve stent 100 with the outflow end 13 as the main anchoring force source.

Referring to fig. 4, it can be seen from the top view of the valve stent 100 that the outflow end 13 and the inflow end 11 of the valve stent 100 provided by the present invention have a larger diameter difference, specifically, the diameter of the tail end of the outflow end 13 is not smaller than the diameter of the head end of the inflow end 11, and the diameter of the narrowest part of the narrowed part 12 along the radial direction of the stent main body 10 is not larger than the diameter of the head end of the inflow end 11. With this arrangement, on one hand, when the stent body 10 is released from the catheter, the radial force generated by the outflow end 13 towards the ascending aorta area 30 is greater than the radial force generated by the inflow end 11 towards the aortic annulus 20, i.e. the anchoring force generated by the outflow end 13 is greater than the anchoring force generated by the inflow end 11, so that the outflow end 13 serves as the main anchoring force source, i.e. the main anchoring position 40 is in the ascending aorta area 30; on the other hand, the diameter of the tail end of the outflow end 13 is larger than that of the head end of the inflow end 11, so that the valve stent 100 conforms to the physiological anatomical structure of a human body, the compression on the aorta can be reduced, and the paravalvular leakage is prevented; furthermore, since the regurgitated patient generally has an ascending aorta dilation, i.e. the regurgitated patient generally has a larger ascending aorta diameter, the diameter of the distal end of the outflow end 13 is larger than the diameter of the distal end of the inflow end 11, and at the same time, the actual requirements of the regurgitated patient on the valve stent 100 can be met.

Alternatively, the diameter of the head end of the inflow end 11 may be 22mm-34mm, and the diameter of the tail end of the outflow end 13 may be 30mm-60mm, which may be specifically set according to the actual use requirement, and is not specifically limited herein. The diameter of the head end of the inflow end 11 and the diameter of the tail end of the outflow end 13 are too large, so that the generated anchoring force is too large, the ascending aorta vascular wall is pressed and even stabbed to the ascending aorta vascular wall, the diameters of the head end of the inflow end 11 and the tail end of the outflow end 13 are too small, the generated anchoring force is small, the relative positions of the valve stent 100 and the native heart tissue cannot be guaranteed not to change, and the function of repairing and/or replacing the defective original heart valve cannot be effectively assisted.

In one embodiment, the thickness of the stent body 10, i.e. the wall thickness of the stent body 10, may be 0.2mm to 0.7mm, and preferably the wall thickness of the stent body 10 is 0.3mm to 0.5mm, for example, the wall thickness of the stent body 10 is 0.3mm, 0.4mm, 0.5mm, etc., which may be specifically set according to the actual use requirement, and is not limited herein. Too big of the wall thickness of support main part 10 can make the intensity of support main part 10 too big to make the anchoring force of production too big, and then produce the oppression to ascending aorta vascular wall, if oppress ascending aorta vascular wall for a long time high strength ground, can make the cell decay in the ascending aorta vascular wall, stab the ascending aorta vascular wall even. The wall thicknesses of the inflow end 11 and the outflow end 13 of the stent main body 10 may be the same, or the wall thickness of the outflow end 13 may be set to be greater than the wall thickness of the inflow end 11, and may be specifically set according to an actual use scenario, which is not specifically limited herein.

In one embodiment, the valve stent 100 is provided with an anchor portion (not shown) provided at the outflow end 13 of the stent body 10. In a specific embodiment, the anchoring portion includes a convex portion (not shown in the drawings) which protrudes toward a direction away from the axial direction of the stent body 10, for example, the diameter of the outflow end 13 of the valve stent 100 becomes gradually larger along the axial direction of the stent body 10, so that a portion of the outflow end 13 near the distal end thereof functions as a convex portion. The provision of the raised portions, on the one hand, enables the valve stent 100 to be snapped into place in the ascending aorta region 30; on the other hand, the arrangement of the convex part enables the contact area of the outflow end 13 of the stent body 10 and the ascending aorta region 30 to be reduced, the outflow end 13 and the convex part can simultaneously generate anchoring acting force on the ascending aorta region 30, namely the anchoring acting force of the stent body 10 on the ascending aorta region 30 is increased, the contact area is reduced, the anchoring effect of the outflow end 13 of the stent body 10 on the ascending aorta region 30 is enhanced due to the increased anchoring acting force, and therefore the anchoring effect of the valve stent 100 and the ascending aorta region 30 is more stable.

Referring to fig. 1, in an embodiment, the distal end of the outflow end 13 is disposed in a non-radial manner, so that a portion of the outflow end 13 contacting the ascending aorta region 30, i.e., the distal end of the outflow end 13, is smooth and not sharp, thereby preventing the distal end of the outflow end 13 from directly contacting the ascending aorta region 30 to cause the outflow end 13 to stab the wall of the ascending aorta, and thus avoiding the formation of dissection or other complications. It is understood that in other embodiments, the distal end of the outflow end 13 may be subjected to other treatments so that the distal end of the outflow end 13 does not cause damage to the ascending aorta vessel wall. Similarly, the head end of the inflow end 11 may be rounded.

Referring to fig. 1, in one embodiment, the stent body 10 has a slit film 111 disposed on both the inner circumferential surface and the outer circumferential surface of the inflow end 11, that is, the slit film 111 is disposed on both the inner side and the outer side of the inflow end 11, and the slit film 111 is disposed to effectively prevent the leakage around the valve. Specifically, the sewing membrane 111 includes a sewing thread and a skirt portion 137, and the skirt portion 137 is sewn to the inflow end 11 of the stent body 10 by the sewing thread, so that the stent body 10 can prevent the occurrence of perivalvular leakage when anchored at a lesion.

Alternatively, the skirt portions 137 sewn to the inside and the outside of the inflow end 11 of the holder main body 10 by the sewing thread may be the same skirt portion 137, i.e., one skirt portion 137 is folded in half, one half of which is sewn to the inside of the inflow end 11 by the sewing thread and the other half of which is sewn to the outside of the inflow end 11 by the sewing thread. Alternatively, the skirt portions 137 sewn to the inside and the outside of the inflow end 11 of the holder body 10 by a suture may be provided separately, and sewn to the inside and the outside of the inflow end 11 of the holder body 10 by a suture, respectively.

With reference to fig. 1, in one embodiment, a skirt portion 137 is sewn to the outflow end 13 of the stent body 10, the skirt portion 137 is sewn to the outflow end 13 by a suture (not shown), the skirt portion 137 can be completely covered on the outflow end 13, that is, the skirt portion 137 disposed on the outflow end 13 is directly contacted with the ascending aorta region 30; alternatively, the skirt portion 137 may be covered on the outflow end 13 with a gap, i.e., in contact with the ascending aorta region 30, a partial region of the outflow end 13 is directly connected to the ascending aorta region 30. The skirt portion 137 may be porous and have a loose pore structure, and the like, and the skirt portion 137 of this structure can increase the friction factor between the outflow end 13 and the contact surface of the ascending aorta region 30, so that the anchoring force of the outflow end 13 of the stent body 10 on the ascending aorta region 30 is increased. It is understood that in other embodiments, the skirt portion 137 may have other shapes and structures, and is not limited thereto.

The material of the suture line and the skirt portion 137 is not particularly limited, and may be specifically set according to the actual use requirement, for example, the material of the suture line may be polyethylene terephthalate (PET), and the material of the skirt portion 137 may be polyethylene terephthalate (PET), a homologous or heterologous biomaterial, and the like.

In one embodiment, the sum of the axial lengths of the inflow end 11 and the narrowing 12 is no greater than the axial length of the outflow end 13. In a particular embodiment, the axial length of the inflow end 11 is not less than the axial length of the constriction 12. The greater the axial length of the outflow end 13 of the stent main body 10 is, the greater the area of the outflow end 13 is, the greater the area of the contact surface between the outflow end 13 and the ascending aorta region 30 is, and the outflow end 13 is more attached to the ascending aorta region 30, so that the anchoring action force generated by the outflow end 13 of the stent main body 10 on the ascending aorta region 30 is increased, the anchoring effect between the outflow end 13 of the stent main body 10 and the ascending aorta region 30 is further enhanced, and the anchoring action of the valvular stent 100 and the ascending aorta region 30 is ensured to be more stable.

With continued reference to fig. 8, in one embodiment, the distal end of the outflow end 13 of the stent body 10 is further provided with a plurality of hooks 17, and the hooks 17 can connect the valve stent 100 with a delivery system, so that the valve stent 100 can be retracted into the delivery system through the hooks 17 and be delivered to a lesion site through a catheter. The number and shape of the hanging buckles 17 are not specifically limited, and the hanging buckles 17 may be specifically arranged according to actual use requirements, for example, the number of the hanging buckles 17 is 2, 3 or more, and the shape of the hanging buckles 17 is circular, semicircular, or T-shaped.

In distinction from the prior art, the present invention provides a valve stent comprising: the support main part, including the inflow end, the end of flowing out and be located the portion of narrowing between the inflow end and the end of flowing out, the portion of narrowing includes the connecting rod of a plurality of connections inflow end and the end of flowing out, a plurality of connecting rods are at the circumference of support main part upward clearance distribution, the portion of narrowing has the flexibility, the end of flowing out has the diameter of fixed action and the end of flowing out end is not less than the diameter of the head end of the inflow end, the portion of narrowing is not more than the diameter of the head end of the inflow end at the diameter of the narrowest department along the radial direction of support main part. The diameter of the tail end of the outflow end is not smaller than that of the head end of the inflow end, so that on one hand, the radial acting force generated by the outflow end and facing the ascending aorta area is larger, and the outflow end is used as a main anchoring force source; on the other hand, the valve stent conforms to the physiological anatomical structure of a human body, can reduce the compression on the aorta, and prevents perivalvular leakage.

In addition, the arrangement of the connecting rod on the narrowing part increases the area of the mesh structure of the narrowing part on one hand, and is more beneficial to subsequent coronary intervention treatment; on the other hand, the connecting rod separates the inflow end and the outflow end of the valve stent, namely the connecting rod divides the valve stent into two parts, so that the narrowing part has flexibility, namely the valve stent has better bending capability, when the valve stent is loaded in a conveying system and is subjected to bow crossing, the valve stent can be divided into two parts to be bent and bow crossing, and the bow crossing capability of the whole conveying system is improved. And the narrowing part has flexibility, so that the valve support can be adaptively deformed to enable the inflow end and the outflow end to be not coaxial under the condition that the ascending aorta area and the aortic valve annulus are not coaxial after the valve support is implanted into a body.

The invention also provides a prosthetic valve assembly. The prosthetic valve assembly includes the prosthetic valve 200 and the valve stent 100 of the above-described embodiment. The valve stent 100 supports the prosthetic valve 200, which may be considered a frame structure supporting the prosthetic valve 200, such that the prosthetic valve 200 supported by the valve stent 100 is relatively fixed to the native heart tissue and more conformable to the native heart tissue by the anchoring connection of the valve stent 100 to the aortic annulus 20 and the ascending aortic region 30, such that the prosthetic valve 200 can assist in repairing and/or replacing the function of a defective native heart valve.

In one embodiment, the prosthetic valve 200 can be directly sutured to the inflow end 11 of the valve holder 100 by sutures to combine the prosthetic valve 200 with the valve holder 100, so that the valve holder 100 can support the prosthetic valve 200, ensure that the prosthetic valve 200 is fixed relative to the native heart tissue, and perform the function of repairing and/or replacing the defective native heart valve. In other embodiments, the prosthetic valve 200 can be sewn to the skirt portion 137, and then the skirt portion 137 can be sewn to the valve holder 100, so as to connect the valve holder 100 and the prosthetic valve 200, that is, the skirt portion 137 can function as a connecting member to connect the valve holder 100 and the prosthetic valve 200.

In an embodiment, the thickness of the prosthetic valve 200 may range from 0.1mm to 1.1mm, for example, the thickness of the prosthetic valve 200 is 0.3mm, 0.4mm, etc., which may be set according to actual use requirements, and is not limited herein. Because the valve stent 100 and the prosthetic valve 200 therein are delivered through a catheter and anchored at the lesion, if the prosthetic valve 200 is too thick, it may not be loaded into the catheter, affecting delivery thereof, and if the prosthetic valve 200 is too thin, it may not function to repair and/or replace the defective original leaflets for some blood types of patients.

In one embodiment, the prosthetic valve 200 is a prosthetic leaflet, which is a thin layer of material, typically made of a homogenous or a heterogeneous biological material, such as porcine pericardium, bovine pericardium, and the like. In other embodiments, the prosthetic leaflets can also be made of artificial ultra-high molecular weight polyethylene, nylon blends, or polymeric materials, such that the fabricated prosthetic leaflets are durable and do not experience tensile deformation or fatigue.

In one embodiment, the number of prosthetic leaflets may be one, two or more, and the like, and is not particularly limited herein. When the number of the prosthetic leaflets is even, the prosthetic leaflets are distributed in central symmetry along the circumferential direction of the inner surface of the inflow end 11, and when the number of the prosthetic leaflets is odd, the prosthetic leaflets are uniformly distributed on the inner surface of the inflow end at equal intervals.

Specifically, as the heart tissue begins the contraction cycle, the prosthetic leaflets move in the same direction, depending on the direction of blood flow, and without damaging the prosthetic leaflets, the prosthetic leaflets create as large an opening in the valve stent 100 as possible to allow blood to flow from one chamber of the heart to another or to the exterior of the heart. When the heart tissue contraction cycle is over, the blood will flow in the opposite direction, pushing and closing the prosthetic leaflet in the opposite direction, preventing retrograde blood flow or backflow. That is, the prosthetic leaflets act as one-way valves in the valve stent 100, allowing blood movement in only one direction, and blocking regurgitation or backflow of blood.

Wherein the prosthetic leaflet may comprise a smooth surface, which is the surface near the outflow end 13 of the valve stent 100, and a rough surface, which is the end near the inflow end 11 of the valve stent 100.

The above description is only an embodiment of the present invention, and not intended to limit the scope of the present invention, and all modifications of equivalent structures and equivalent processes, which are made by using the contents of the present specification and the accompanying drawings, or directly or indirectly applied to other related technical fields, are included in the scope of the present invention.

Claims (10)

1. A valve stent, comprising:

support main part, including the inflow end, the end of flowing out and being located the inflow end with flow out the portion of narrowing between the end, the portion of narrowing includes a plurality of connections the inflow end with the connecting rod of the end of flowing out, it is a plurality of the connecting rod is in the circumferential upper gap distribution of support main part, its characterized in that, the portion of narrowing has flexibility, the end of flowing out has the fixed action just the diameter of the end of flowing out is not less than the diameter of the head end of the inflow end, the portion of narrowing is following the diameter of the narrowest department of the radial direction of support main part is not more than the diameter of the head end of the inflow end.

2. The valve stent of claim 1,

the sum of the axial lengths of the inflow end and the narrowing is no greater than the axial length of the outflow end.

3. The valve stent of claim 2,

the axial length of the inflow end is not less than the axial length of the narrowing.

4. The valve stent of any one of claims 1-3,

the outflow end varies in radial dimension in an axial direction along the stent body.

5. The valve stent of claim 4,

the tail end of the outflow end and/or the head end of the inflow end are/is arranged in a non-radial mode, so that the tail end of the outflow end and/or the head end of the inflow end are/is smooth.

6. The valve stent of claim 5,

the valve stent further includes an anchoring portion disposed at the outflow end.

7. The valve stent of claim 6,

the anchor portion includes a projecting portion that projects toward a direction away from the axial direction of the holder main body.

8. The valve stent of any one of claims 5-7,

the outflow end is provided with a skirt portion.

9. The valve stent of claim 8,

the skirt portion is continuously or discontinuously disposed at the outflow end.

10. A prosthetic valve assembly, characterized in that,

the prosthetic valve assembly comprises the valve stent of any one of claims 1-9 and a prosthetic valve provided to the valve stent.

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