CN114469444A

CN114469444A - Valve stent and valve prosthesis

Info

Publication number: CN114469444A
Application number: CN202011262708.6A
Authority: CN
Inventors: 潘孔荣; 张存义; 张海
Original assignee: Peijia Medical Technology Suzhou Co ltd
Current assignee: Peijia Medical Technology Suzhou Co ltd
Priority date: 2020-11-12
Filing date: 2020-11-12
Publication date: 2022-05-13

Abstract

The application discloses a valve support and a valve prosthesis, wherein the valve support comprises a valve support main body, a valve support body and a valve support body, wherein the valve support main body comprises a valve leaflet support and a skirt support which are connected with each other; at least one first anchoring part connected with the skirt stent and arranged along the circumferential direction of the leaflet stent, wherein in the unfolded state, the first anchoring part is positioned outside the leaflet stent, and a certain distance exists between the first anchoring part and the leaflet stent in the radial direction of the leaflet stent; at least one second anchor portion connected to the leaflet brace, at least a portion of the second anchor portion being positioned outside of the leaflet brace in the deployed state; wherein the valve stent is fixed within the heart by the first anchoring portion and/or the second anchoring portion penetrating into the native valve. The valve support is fixed in the heart through the first anchoring part and/or the second anchoring part, and the valve support is prevented from being displaced, and meanwhile, the valve support is enabled to better maintain the design state.

Description

Valve stent and valve prosthesis

Technical Field

The application relates to the technical field of medical equipment, in particular to a valve stent and a valve prosthesis.

Background

The valvular heart disease is a very common heart disease, and valvular heart diseases not only endanger life safety and influence life quality, but also bring serious burden and pressure to families and society. Currently, a valve prosthesis can be implanted at a diseased heart valve by a heart valve replacement procedure, i.e. by an invasive, minimally invasive method, to replace the originally diseased heart valve of a patient. However, the valve holder is prone to displacement due to the high pressure of blood flow between the atrium and ventricle.

While some techniques now prevent valve stents from dislodging, valve stents formed by these techniques have certain drawbacks. For example, hooks are provided on the upper end positioning members of the valve stent, and the valve stent is fixed by sandwiching the heart tissue between the hooks and the upper end positioning members, but the size of the hooks that need to enclose the heart tissue may be relatively large, so that the deformation amount of the hooks during the release and compression of the valve stent may be relatively large, firstly, the hooks with large deformation amount may exert a large force on the delivery device loaded with the valve stent, and the delivery device may be easily damaged, secondly, the hooks may not be released to the state of enclosing the heart tissue when the valve stent is released, the release precision is high, and the feasibility is not high during the actual operation. For example, although barbs are provided on the leaflet holders to catch the lower edges of the leaflets of the human body, the leaflet holders of such valve holders are easily pressed by the heart during the cardiac cycle, and thus the leaflet holders cannot maintain the designed shape.

Disclosure of Invention

The present application provides a valve stent and a valve prosthesis, which enable the valve stent to better maintain a design state while fixing the valve stent in the heart and preventing the valve stent from being displaced by a first anchoring portion and/or a second anchoring portion.

In order to solve the above technical problem, the present application proposes a valve stent including a valve stent main body, at least one first anchoring portion, and at least one second anchoring portion;

the valve support main body comprises a valve support and a skirt support which are connected with each other;

at least one first anchoring part is connected with the skirt stent and arranged along the circumferential direction of the valve leaflet stent, and in the unfolding state, the first anchoring part is positioned outside the valve leaflet stent, and a certain distance exists between the first anchoring part and the valve leaflet stent in the radial direction of the valve leaflet stent;

at least one second anchoring portion connected to the leaflet brace, at least a portion of the second anchoring portion being positioned outside of the leaflet brace in the deployed state;

wherein the valve stent is fixed within the heart by the first anchoring portion and/or the second anchoring portion penetrating into the native valve.

Wherein, the acting force generated by the deformation of the anchoring part positioned at the outer side is smaller than the acting force generated by the deformation of the anchoring part positioned at the inner side;

wherein, first anchor portion and second anchor portion are all called anchor portion.

Wherein the cross-sectional area of the anchoring portion located on the outer side is smaller than the cross-sectional area of the anchoring portion located on the inner side.

Wherein, in the radial direction, the second anchor is located between the leaflet brace and the first anchor.

Wherein the length of the coincidence of the orthographic projection of the first anchoring part on the axis of the valve leaflet bracket and the orthographic projection of the second anchoring part on the axis of the valve leaflet bracket is 2-6 mm;

in the fully deployed state, the first anchoring portion and the second anchoring portion are spaced apart by 2mm to 4 mm.

Wherein the first anchoring portion has at least one first barb for penetrating the native valve and/or the second anchoring portion has at least one second barb for penetrating the native valve;

wherein the first barbs and/or the second barbs extend radially outward.

Wherein, the second anchoring part extends from the outflow end of the valve leaflet support to the inflow end along the outflow end.

Wherein the second anchor portion includes:

a first bending part extending outward from an outflow end of the leaflet bracket in a radial direction of the leaflet bracket;

and the second bending part extends inwards along the radial direction of the valve leaflet support or is parallel to the axis of the valve leaflet support.

Wherein the skirt stent comprises at least one first skirt petal and at least one second skirt petal,

the first skirt petals have a dimension in the radial direction of the leaflet frame that is less than a dimension of the second skirt petals in the radial direction of the leaflet frame.

In order to achieve the above object, the present application provides a valve prosthesis including the above valve stent.

The valve support comprises at least one first anchoring part arranged along the circumferential direction of the valve support, the valve support is used for penetrating into a native valve through the first anchoring part and/or the second anchoring part and fixing the valve support in the heart, the second anchoring part is connected with the valve support in the valve support main body, in a spreading state, at least part of the second anchoring part is positioned at the outer side of the valve support, so that part of force of an annulus is applied to the second anchoring part to apply part of force of the annulus to one end of the valve support, inward acting force is applied to one end of the valve support, outward force brought to one end of the valve support by the first anchoring part can be relieved, deformation of the valve support is avoided, compression on the first anchoring part arranged at the other end of the valve support is relieved, the valve support is stable, and the valve located in the valve support can work stably in an actual working environment, so that the valve leaflet bracket can better maintain the design state.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the description of the embodiments are briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

FIG. 1 is a schematic structural view of an embodiment of a valve stent of the present application;

FIG. 2 is a perspective view of a first anchoring portion and first barbs of a valve stent of the present application;

FIG. 3 is a schematic view of a detail of another embodiment of a valve stent of the present application;

FIG. 4 is a schematic view of a detail of a portion of yet another embodiment of a valve stent of the present application;

FIG. 5 is a schematic view of a valve stent according to another embodiment of the present application;

FIG. 6 is a schematic view of the position of the first anchoring portion and the skirt hanger of the present application;

FIG. 7 is a schematic view of a valve stent of the present application from another perspective;

FIG. 8 is a schematic representation of the positional parameters of the first and second skirt petals shown in FIG. 7;

fig. 9 is a schematic view of the valve prosthesis of the present application implanted in a heart.

Detailed Description

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

As shown in fig. 1, the fixing structure of the valve stent 100 of the present application is a piercing structure to pierce the native valve through the first anchoring portion 123 of the valve stent 100 to fix the valve stent 100 in the heart, and the first anchoring portion 123 is spaced apart from the leaflet stent 110 to protect the leaflet stent 110 from being pressed by the diseased valve myocardial tissue and the native leaflets during its use, so that the valve stent 100 can be fixed in the heart through the first anchoring portion 123 and prevent the valve stent 100 from being displaced, and at the same time, the leaflet stent 110 can better maintain the designed state, and further, the movement of the leaflets on the leaflet stent 110 is not affected. In addition, because the first anchoring part penetrates into the native valve to improve the fit between the valve stent and myocardial tissue, the deformation amount needed for penetrating into the native valve is small, so that the part penetrating into the native valve can be pressed back to a compressed state by applying small force, and thus, the part penetrating into the native valve on the valve stent 100 positioned in the delivery device can not apply too much force on the delivery device, and the delivery device is prevented from being damaged; in addition, the release accuracy is not too high, the valve stent 100 can be prevented from being displaced by the first anchoring part 123 in the actual operation process, and the feasibility of the actual operation is ensured.

As shown in fig. 1, the present application proposes a new valve stent 100, the valve stent 100 including a valve stent main body, at least one first anchoring portion 123 and at least one second anchoring portion 140 to fix the valve stent 100 in the heart by penetrating a native valve through the first anchoring portion 123 and/or the second anchoring portion 140, and the second anchoring portion 140 being connected to a leaflet stent 110 in the valve stent 100 main body, at least a portion of the second anchoring portion 140 being located outside the leaflet stent 110 in a deployed state, such that a portion of a force of a native annulus is applied to the second anchoring portion 140 to apply a portion of a force of a native annulus to the other end of the leaflet stent 110, and an inward acting force applied to the other end of the leaflet stent 110 relieves an outward force of the first anchoring portion 123 to the other end of the leaflet stent 110, prevents the leaflet stent 110 from being deformed, relieves compression of the native annulus on the first anchoring portion 123 provided at one end of the leaflet stent 110, the leaflet support 110 is stable, and the leaflets in the valve support 100 can stably work in the actual working environment.

The valve stent body includes a leaflet stent 110 and a skirt stent 120 that are connected to each other. The skirt stent 120 and the leaflet stent 110 can be cut from the same tube. The material of the tubing may be a memory metal so that the valve stent 100 made using the memory metal can be self-expanding from a compressed state.

The leaflet holders 110 are generally cylindrical. The diameter of the cylinder may be between 28 and 35 mm. It is understood that the leaflets can be disposed within the leaflet brace 110.

The leaflet support 110 can also be provided with mounting holes to facilitate positioning and mounting of the valve.

In addition, the end of the leaflet holders 110 distal from the skirt holders extends axially to form an auxiliary element 130.

For convenience of description, both ends of the leaflet braces 110 are defined as an outflow end 112 and an inflow end 111, respectively. In the deployed state, the inflow end 111 is located upstream of the outflow end 112 in the blood flow direction.

Specifically, the skirt stent 120 can extend from the inflow end 111 in a direction away from the leaflet stent 110, and more specifically, the skirt stent 120 can extend from the end of the leaflet stent 110 away from the auxiliary element 130. Also, the leaflet braces 110 and skirt braces 120 can be circular-arc transitions, or even large-arc transitions.

The skirt stent 120 can expand radially outward from the end of the leaflet stent 110 in a radial shape.

Wherein, at least one first anchor portion 123 is connected with shirt rim support 120 to make valve support 100 pierce through native valve and fix in the heart through first anchor portion 123, can improve the laminating degree of valve support 100 and heart, can restrict the axial degree of freedom of valve support 100 under the pulling force of native valve, effectively reduced valve support 100 the probability that the aversion appears after implanting. In addition, in the deployed state, the first anchoring portion 123 is located outside the leaflet stent 110, and there is a certain distance between the first anchoring portion 123 and the leaflet stent 110 in the radial direction of the leaflet stent 110, so that the first anchoring portion 123 and the leaflet stent 110 are separated, and thus the leaflet stent 110 is not affected by the pressure of diseased valve myocardial tissue and native leaflets during the use process, and the design state can be better maintained, and further the movement of the leaflets on the leaflet stent 110 is not affected. The first anchoring portion 123 is provided with a first barb 124 for piercing the native valve, wherein the first anchoring portion 123 may be linear, curvilinear or otherwise shaped.

To enable the first barbs 124 to more easily penetrate into the native valve, at least portions of the first barbs 124 can extend radially outward of the leaflet braces 110. Preferably, the portion of the first barbs 124 that penetrate the native valve is formed extending radially outward of the leaflet braces 110.

Additionally, the first barb 124 may also extend along the outflow end 112 in the direction of the inflow end 111 to facilitate penetration of the first barb 124 into the native valve.

In this embodiment, the first barb 124 may be linear, curvilinear, or otherwise shaped.

In addition, as shown in fig. 2, the first anchoring portion 123 may be provided with a barb gap 125 adapted to the first barb 124, so that the first barb 124 can be pressed into the barb gap 125, and when the valve stent 100 is in a compressed state, the first barb 124 is embedded in the barb gap 125, and the first barb 124 and the first anchoring portion 123 are on the same layer, so that the valve stent 100 can be loaded into the delivery device more easily. Optionally, a first barb 124 is cut from the first anchor portion 123.

The length h of the first barb 124 is 2mm to 12 mm. The length h of the first barb 124 may be a length of a connection line between an end point of an end of the first barb 124 connected to the first anchoring portion 123 and an end point of an end of the first barb 124 far from the first anchoring portion 123. Preferably, the length h of the first barb 124 is 2mm to 3mm, so that the first barb 124 cannot easily slip off after hooking the native valve annulus or the native valve leaflets, and the phenomenon that the first barb 124 punctures into the heart tissue to damage and puncture the blood vessel cannot occur.

Specifically, the included angle d between the first barb 124 and the first anchoring portion 123 may be 30 ° to 40 °, or 50 ° to 70 °. Preferably, the included angle d between the first barbs 124 and the first anchoring portions 123 may be 50 ° to 60 °, so that the heart tissue can be more easily hooked, and when the valve stent 100 enters the corresponding delivery device, the first barbs 124 do not puncture the delivery device or increase the sheath resistance.

The thickness e of the first barbs 124 may be 0.2mm to 0.5 mm. Preferably, the thickness e of the first barbs 124 may be 0.2mm to 0.3mm, which may maintain a good supporting force of the first barbs 124. In this embodiment, the first barb 124 may be of uniform thickness (regardless of the tip), where the thickness e of the first barb 124 is the thickness at a location excluding the tip.

The width f of the first barb 124 may be 0.2mm to 0.6 mm. Preferably, the width f of the first barb 124 is 0.2 mm-0.4 mm, so that the ratio of the width f to the thickness e of the first barb is 2/3-2, which facilitates obtaining a more stable structure of the first barb 124 and provides better supporting force.

One or more first barbs 124 may be disposed on each first anchoring portion 123. The spacing distance g between the barb gaps 125 corresponding to two adjacent first barbs 124 may be 1.5-9 mm. Given the nature of the heart anatomy, 1.5-3mm is preferred, and the reasonable length h and separation g of the first barbs 124 will result in an optimal design due to chordal tissue anchoring distance limitations of the native valve.

The number of first barbs 124 may be 1-5. Preferably, the number of the first barbs 124 is 3, and 3 first barbs 124 can provide a reasonable length and anchoring force for the valve stent 100, and improve the bonding strength between the first barbs 124 and the native valve to maintain the stability and displacement resistance of the valve stent 100.

In this embodiment, to prevent the first barb 124 from abrading the surrounding tissue, the tip of the first barb 124 is blunted or radiused.

As shown in fig. 3, the second anchoring portion 140 can be connected to the outflow end 112 of the leaflet holders 110, as long as the location at which the second anchoring portion 140 is connected to the leaflet holders 110 is different from the location at which the skirt holder 120 is connected to the leaflet holders 110.

The second anchoring portion 140 can extend from the leaflet brace 110 in a direction along the outflow end 112 toward the inflow end 111.

Further, the second anchoring portion 140 includes a first bent portion 141 and a second bent portion 142. The first bend 141 can extend from the leaflet bracket 110 radially outward of the leaflet bracket 110. The second bending portion 142 may extend inward from the free end of the first bending portion 141 along the radial direction of the leaflet bracket 110, or may be parallel to the axis of the leaflet bracket 110, so as to prevent the second bending portion 142 from penetrating into the native valve annulus when the native valve annulus applies pressure to the second anchoring portion 140, which may result in the second anchoring portion 140 failing to share the force applied by the native valve annulus.

The first bending portion 141 and the second bending portion 142 may be in arc transition connection, or even in great arc transition connection, so as to prevent the native valve annulus from being stabbed by the connection portion of the first bending portion 141 and the second bending portion 142 when the native valve annulus applies pressure to the second anchoring portion 140.

As shown in fig. 3 and 4, the length PL of the first bent portion 141 is 6mm to 8 mm.

The acute included angle BR between the first bending portion 141 and the leaflet brace 110 is 40-70 °.

The length of the second bent portion 142 is 2mm to 6 mm.

The acute included angle DB between the second bend 142 and the leaflet brace 110 is 30-50.

When the valve stent is in the fully expanded state, the distance M between the second anchoring portion 140 and the first anchoring portion 123 is 2mm to 4 mm.

Second barb 143 may be provided on second anchor portion 140 to pierce the native valve through second barb 143, thereby piercing the native valve through second barb 143 on second anchor portion 140 and improving the fit of valve stent 100 with the myocardial tissue. The setting mode and size of the second barb 143 can refer to the setting mode and size of the first barb 124 on the first anchoring portion 123, which is not described herein.

In the radially disposed position of the second anchoring portion 140, as shown in fig. 4, a partial region of the second anchoring portion 140 may be located on the side of the first anchoring portion 123 away from the leaflet holder 110. Of course, as shown in fig. 1, the second anchoring portion 140 is located between the leaflet holder 110 and the first anchoring portion 123 in the radial direction of the valve holder.

In the radial setting positions of the two second anchoring portions 140, during the closing process of the native valve annulus, a force is applied to the outer anchoring portion first, so that the outer anchoring portion can be compressed to a degree of abutting with the inner anchoring portion, an outward radial supporting force is generated by the inner anchoring portion to support the native valve annulus, so that the native valve annulus and the leaflet support 110 maintain a certain distance in the radial direction of the valve support 100, and the anchoring force is supplemented by the inner anchoring portion while the anchoring force is distributed to different parts of the leaflet support 110, so that the force applied by the native valve annulus is more uniformly applied to the valve support 100, and the leaflet support 110 is more stable. Here, the first anchor portion 123 and the second anchor portion 140 are both referred to as anchor portions.

Further, the outward-located anchor may deform less than the inward-located anchor to present the valve stent 100 of the present application as a "cork" configuration, such that the outward-located anchor may be compressed relatively easily into abutment with the inward-located anchor to reduce the likelihood of deformation of the leaflet stent 110 when the native annulus applies force only to the outward-located anchor, and such that after abutment of the outward-located anchor and the inward-located anchor, the anchoring force may be supplemented by the inward-located anchor while being distributed to different portions of the leaflet stent 110 to avoid deformation of the leaflet stent 110 to better tissue fit the valve stent 100 to the native leaflets.

The present application can adjust the effort that the anchoring portion deforms and produces by adjusting the included angle between the axes of the anchoring portion and the leaflet brace 110, the distance of the anchoring portion and the leaflet brace 110, and/or the cross-sectional area of the anchoring portion. Alternatively, the force of the anchor portion can be made smaller by reducing the acute angle between the anchor portion and the axis of the leaflet brace 110, the distance between the anchor portion and the leaflet brace 110, and/or the cross-sectional area of the anchor portion.

Illustratively, the cross-sectional area of the anchoring portion on the outer side is smaller than the cross-sectional area of the anchoring portion on the inner side.

In addition to the two radial placement positions described above, the second anchoring portion 140 may have another radial placement position. Specifically, the radial distance from the axis of the valve stent 100 is equal to the radial distance from the axis of the first anchoring portion 123 to the end of the second anchoring portion 140 that is away from the axis of the valve stent 100.

In addition, in the circumferential direction, the first anchoring portions 123 and the second anchoring portions 140 may be disposed in a staggered manner, that is, there is one second anchoring portion 140 located between two first anchoring portions 123 to provide more supporting points in the circumferential direction, which can largely compensate for the deficiency of adherence and provide better radial supporting force and anchoring force in cooperation with the leaflet stent 110, so that the valve stent 100 better fits the quasi-circular blood vessel or the native valve, thereby improving the leakage prevention effect of the valve stent 100.

Alternatively, the first anchoring portion 123 and the second anchoring portion 140 may be disposed correspondingly, that is, the first anchoring portion 123 and the second anchoring portion 140 corresponding thereto may be on the same axial section of the valve stent 100. Preferably, orthographic projections of the second anchor 140 and the first anchor 123 on the axis of the valve stent 100 at least partially overlap, so that when the original annulus compresses the outward-located anchor into contact with the inward-located anchor, the transmission of force between the first anchor 123 and the second anchor 140 can make the forces applied to the leaflet stent 110 by the first anchor 123 and the second anchor 140 as consistent as possible, so that the leaflet stent 110 can maintain the original design form as possible. Optionally, the length at which the orthographic projection of the first anchoring portion 123 on the axis of the leaflet frame 110 and the orthographic projection of the second anchoring portion 140 on the axis of the leaflet frame 110 coincide is 2mm-6 mm. In addition, referring to fig. 4, when the anchoring portion located at the outer side is in contact with the anchoring portion located at the inner side, the overlapping length OL of the anchoring portion located at the outer side and the anchoring portion located at the inner side is 2mm to 4 mm.

Alternatively, as shown in fig. 1, the number of the first anchoring portions 123 and the number of the second anchoring portions 140 may be the same. Of course, in other implementations, for example, as shown in fig. 5, the number of the second anchoring portions 140 may be greater than the number of the first anchoring portions 123, wherein a portion of the second anchoring portions 140 are disposed in one-to-one correspondence with the first anchoring portions 123, and each of the other portions of the second anchoring portions 140 may be located between two first anchoring portions 123, so as to increase the number of supporting points on the circumference by increasing the number of the second anchoring portions 140, so as to improve the leakage-proof effect of the valve stent 100.

Preferably, all of the anchors in the cross-section of the valve stent 100 are shaped to match the shape of the native annulus to improve leakage prevention. For example, the native valve is the mitral valve, and the cross-section of the valve stent 100 is formed with all of the anchors in a "D" or "C" shape.

The valve stent 100 of the present application can exist in at least two configurations.

For example, the second anchoring portion 140 and the second barbs 143 provided thereon can be assembled by being restored to the cutting, that is, the second anchoring portion 140 and the second barbs 143 provided thereon are in the same plane as the leaflet braces 110, so that the assembly of the first anchoring portion 123 and the leaflet braces 110 will not be affected.

For another example, by placing second anchor portion 140 within first anchor portion 123 and directly radially compressing, the assembly process will partially increase the difficulty of assembly of the anchor portion, but a more stable and precise release process is also achieved.

Further, the skirt stent 120 can include a first extension 121 connected to the leaflet stent 110. The first extension 121 can extend from the leaflet frame 110 in an axial direction of the leaflet frame 110 and radially outward therefrom. Specifically, the first anchoring portion 123 may extend from the first extension 121 in a direction from the inflow end 111 to the outflow end 112.

The first extension portion 121 and the first anchoring portion 123 may be connected in a circular arc transition manner. According to the anatomical structure, the heart tissue can generate radial pressure on the valve stent 100, and the stressed position is the arc transition position of the first anchoring part 123 and the first extending part 121 in the skirt stent 120; at this time, the part is deformed correspondingly, and the valve leaflets in the valve leaflet support 110 are restrained from surrounding tissues by a small amount of deformation due to the large arc transitional connection between the skirt support 120 and the valve leaflet support 110, so that the function of the valve leaflets cannot be greatly influenced, and the valve paravalvular leakage caused by incomplete valve closure is avoided.

As shown in fig. 6, the first anchoring portion 123 includes a first anchoring portion root portion and a first anchoring portion top portion, wherein the first anchoring portion root portion is an end portion of the first anchoring portion 123 close to the first extension portion 121, and the first anchoring portion top portion is an end portion of the first anchoring portion 123 far from the first extension portion 121. It is understood that there can be a variety of positional relationships between the first anchoring portion 123 and the leaflet holder 110, such as the first anchoring portion 123 being parallel to the axis of the valve holder body; also for example, relative to the first anchor tip, the first anchor root is closer to the axis of the valve stent body, i.e., the first anchor 123 extends from the first extension 121 radially outward of the valve stent body, although not limited thereto. In addition, the angle at which the at least one first anchoring portion 123 extends radially outward may be the same, and of course, may be different.

Among them, the approach in which the root of the first anchoring portion is closer to the axis of the leaflet holder 110 is preferable because such a positional relationship allows the valve holder 100 to obtain a higher radial anchoring force.

Further, as shown in fig. 6, an included angle a exists between the first anchoring portion 123 and the first extending portion 121. Preferably, a is 120 °, though not limited thereto, and a may have other values. An angle b exists between the first extension 121 and the leaflet brace 110. The final position of the first anchor 123 will be determined based on a and b in combination. As shown in fig. 3, an included angle DT exists between the first anchoring portion 123 and the leaflet brace 110. Optionally, the angle DT is 30-60 degrees, DT must not be too large, and DT determines the amount of anchoring force of the first anchor against the native leaflet tissue, generally speaking, the larger the angle DT, the more the first anchor will generate the anchoring force, the excessive anchoring force will generate the outflow obstruction, and some resistance to sheathing will be generated.

It can be appreciated that when the valve stent 100 is in the deployed state, as shown in fig. 3, there is a distance ML between the first anchoring portion 123 and the leaflet stent 110, and the first anchoring portion root is at a distance from the leaflet stent 110, i.e., the first anchoring portion 123 is separated from the leaflet stent 110. Alternatively, the first anchoring portion 123 may be extended from a middle portion of the first extension portion 121.

In addition, the first anchoring portions 123 do not touch the leaflet frame 110 during the cardiac cycle, which prevents the first anchoring portions 123 from interfering with the leaflet frame 110 so that the leaflet frame 110 can maintain the design form well.

In addition, the valve stent main body is provided with a hollow area adapted to the first anchoring portion 123, so that when the valve stent 100 is in a compressed state, the first anchoring portion 123 is embedded in the hollow area and is located on the same circumferential surface as the valve stent main body, so that the valve stent 100 can be more easily loaded into the delivery device. As shown in fig. 1, when the valve stent 100 is in the expanded state, the first anchoring portion 123 and the leaflet stent 110 are coaxial but are located on different circumferential surfaces, and the distance between the first anchoring portion 123 and the axis of the leaflet stent 110 is greater than the radius of the leaflet stent 110, so that the first anchoring portion 123 contacts the native valve tissue and the leaflet stent 110 maintains a relatively stable structure. To facilitate the valve stent 100, the valve stent 100 in the compressed state may be obtained by cutting a tubular body made of memory metal material, and the valve stent 100 in the compressed state is processed to make the valve stent 100 in the expanded state, so as to obtain the valve stent 100 capable of being switched between the expanded state and the compressed state.

Further, the skirt hanger 120 may further include a raised portion 122 extending from the free end of the first extension 121 in a direction from the outflow end 112 to the inflow end 111. Wherein the free end of the first extension 121 is opposite the connected end of the first extension 121 and the leaflet brace 110. The tilted portion 122 is located on a side of a tangent plane of the free end of the first extending portion 121 away from the inflow end 111. The first extension part 121 and the tilted part 122 can be in arc transition connection, so that the connection part of the first extension part 121 and the tilted part 122 can be ensured to be a smooth arc surface, and the heart myocardial tissue can be prevented from being punctured by the connection part of the first extension part 121 and the tilted part 122. As shown in fig. 4, even the first extending portion 121 and the tilted portion 122 are in a great arc transition connection.

A certain included angle can be formed between the tilting portion 122 and the first extension portion 121 to prevent the first extension portion 121 from extending out and stabbing cardiac muscle tissue, so as to prevent stimulation of cardiac muscle and influence on normal function of the heart.

In this embodiment, as shown in fig. 7, valve stent 100 may be generally flower-shaped in its entirety, and skirt stent 120 may be viewed as comprising a plurality of petal-like structures, which may be referred to as skirt petals, i.e., skirt stent 120 may comprise a plurality of skirt petals. Specifically, the number of skirt petals in the skirt stent 120 can be 6-13. Preferably, the total number of the skirt petals can be 6-10, so that the valve support 100 can be well attached to cardiac muscle tissue without increasing the resistance of the valve support 100 entering a sheath.

Wherein each skirt petal may comprise a first extension part 121 and a raised part 122 connected in sequence. Also, the first extensions 121 may be the ends of the skirt petals near the leaflet holders 110. Specifically, the raised portion 122 may have a circular arc shape, wherein the circular arc radius of the raised portion 122 may be 1-3 mm. Preferably, the radius of the circular arc of the tilted part 122 may be 1-2mm, which can better fit with the anatomical structure of the heart and prevent the valve stent 100 from moving under the condition of high blood pressure.

In one embodiment, the skirt stent 120 comprises at least one first skirt petal 126 and at least one second skirt petal 127, wherein the dimension of the first skirt petal 126 in the radial direction of the leaflet stent 110 is smaller than the dimension of the second skirt petal 127 in the radial direction of the leaflet stent 110, so that the skirt stent 120 is configured to resemble a "D" or "C" shape, which is similar to the "D" or "C" shape according to the contour of the native valve annulus to which the native valve of the human heart is attached, so that the skirt stent 120 can better conform to the contour of the native valve annulus, thereby facilitating the anastomosis of the native valve anatomy, reducing the compression on the aorta, and preventing perivalvular leakage.

Specifically, the length and/or angle of the first extension 121 and the raised portion 122 of the first skirt petal 126 can be different from the length and/or angle of the first extension 121 and the raised portion 122 of the second skirt petal 127; the first skirt petals 126 are made smaller in size in the radial direction of the leaflet frame 110 than the second skirt petals 127 in the radial direction of the leaflet frame 110.

For example, as shown in figure 8, the first extensions 121 of the first skirt petals 126 have a length that is less than the length of the first extensions 121 of the second skirt petals 127.

For another example, the length of the raised portion 122 of the first skirt petals 126 is less than the length of the raised portion 122 of the second skirt petals 127.

For another example, the acute angle i of the first extension 121 of the first skirt petal 126 to the axis of the leaflet brace 110 is less than the acute angle k of the first extension 121 of the second skirt petal 127 to the axis of the leaflet brace 110.

As another example, the acute included angle j of the raised portion 122 of the first skirt petal 126 with the axis of the leaflet brace 110 is less than the acute included angle l of the raised portion 122 of the second skirt petal 127 with the axis of the leaflet brace 110.

In summary, the skirt stent 120 connected to the leaflet stent 110 of the present application includes at least one first anchoring portion 123 disposed along the circumferential direction of the leaflet stent 110, the valve stent 100 is configured to be fixed in the heart by penetrating the native valve through the first anchoring portion 123, the degree of fitting between the valve stent 100 and the heart can be improved, the axial freedom of the valve stent 100 can be constrained under the tensile force of the native valve, and the probability of displacement of the valve stent 100 after implantation is effectively reduced; and under the state of expanding, first anchor portion 123 is located the leaflet support 110 outside, and there is a certain interval in the radial direction of leaflet support 110 in first anchor portion 123 and leaflet support 110, make first anchor portion 123 and leaflet support 110 separate, let leaflet support 110 not receive the oppression influence of pathological valve cardiac muscle tissue and native leaflet in its use, can fix valve support 100 in the heart and prevent valve support 100 aversion through first anchor portion 123 like this, make better maintenance design state of leaflet support 110, and then can not cause the influence to the activity of leaflet on leaflet support 110. In addition, because the first anchoring part 123 pierces the native valve to improve the fit between the valve stent 100 and the myocardial tissue, the deformation amount required for piercing the native valve is small, so that the portion piercing the native valve can be pressed back to the compressed state by applying only a small force, and thus the portion piercing the native valve on the valve stent 100 positioned in the delivery device does not apply too much force to the delivery device, and damage to the delivery device is avoided. In addition, the release accuracy is not required to be high, so that the valve stent 100 can be prevented from being displaced by the first anchoring part 123 in the actual manufacturing process, and the feasibility of the actual manufacturing is ensured.

Further, the present application also proposes a valve prosthesis 200, the valve prosthesis 200 including the valve stent 100 of the above-described embodiment.

Optionally, the valve prosthesis 200 further comprises a leakage-proof device to improve the leakage-proof performance of the valve prosthesis 200, so as to avoid the occurrence of paravalvular leakage and the like caused by the release of the valve stent 100. As shown in FIG. 9, the leak protection device 210 and the valve stent 100 can be combined to form a valve prosthesis 200, which is implanted into the heart. The heart includes a left atrium LA, a left ventricle LV, and a mitral valve MV. The mitral valve includes an anterior leaflet AL on the anterior side a of the valve and a posterior leaflet PL on the posterior side P of the valve. These leaflets attach to the chordae tendineae CT, which are then secured to the heart wall with papillary muscles PM. The blood vessel is then pumped out of the left ventricle into the aorta AO with the aorta AV prevented from regurgitation.

Valve prosthesis 200 may also include leaflets. The leaflets may be positioned within valve stent 100 and fixedly attached to valve stent 100. The leaflets may be composed of a thin layer of material, usually a biofilm, that is mobile when blood flows. The number of leaflets provided may be two or more. Of course, the valve prosthesis 200 may also include a one-way valve disposed within the valve stent 100, which may be used to block blood regurgitation.

The above embodiments are merely examples and are not intended to limit the scope of the present disclosure, and all modifications, equivalents, and flow charts using the contents of the specification and drawings of the present disclosure or those directly or indirectly applied to other related technical fields are intended to be included in the scope of the present disclosure.

Claims

1. A valve stent, comprising:

a valve stent body including a leaflet stent and a skirt stent connected to each other;

at least one first anchoring portion connected to the skirt stent and disposed along a circumferential direction of the leaflet stent, the first anchoring portion being located outside the leaflet stent in a deployed state, and the first anchoring portion and the leaflet stent having a certain distance in a radial direction of the leaflet stent;

at least one second anchor portion connected to the leaflet brace, at least a portion of the second anchor portion being positioned outside of the leaflet brace in the deployed state;

wherein the valve stent is fixed within the heart by the first and/or second anchoring portions penetrating the native valve.

2. The valve stent of claim 1, wherein:

the acting force generated by the deformation of the anchoring part positioned at the outer side is smaller than the acting force generated by the deformation of the anchoring part positioned at the inner side;

wherein the first anchoring portion and the second anchoring portion are both referred to as the anchoring portion.

3. The valve stent of claim 2, wherein:

the cross-sectional area of the anchor portion located on the outer side is smaller than the cross-sectional area of the anchor portion located on the inner side.

4. The valve stent of claim 2,

in a radial direction, a second anchor is located between the leaflet brace and the first anchor.

5. The valve stent of claim 4,

the length of the coincidence of the orthographic projection of the first anchoring part on the axis of the valve leaflet bracket and the orthographic projection of the second anchoring part on the axis of the valve leaflet bracket is 2-6 mm;

in a fully deployed state, the first anchor portion and the second anchor portion are spaced apart by 2mm to 4 mm.

6. The valve stent of claim 1,

the first anchor portion has at least one first barb for penetrating the native valve, and/or the second anchor portion has at least one second barb for penetrating the native valve;

wherein the first barb and/or the second barb extend radially outward.

7. The valve stent of claim 1,

the second anchoring portion extends from an outflow end of the leaflet brace in a direction along the outflow end toward an inflow end.

8. The valve stent of claim 7, wherein the second anchor comprises:

a first bending portion extending from an outflow end of the leaflet bracket radially outward of the leaflet bracket;

a second bend extending radially inward of the leaflet brace or parallel to an axis of the leaflet brace.

9. The valve stent of claim 1, wherein the skirt stent comprises at least one first skirt petal and at least one second skirt petal,

the first skirt petals have a dimension in the radial direction of the leaflet brace that is less than a dimension of the second skirt petals in the radial direction of the leaflet brace.

10. A valve prosthesis comprising the valve stent of any one of claims 1-9.