CN113662709B

CN113662709B - Valve stent and valve prosthesis

Info

Publication number: CN113662709B
Application number: CN202010409100.5A
Authority: CN
Inventors: 潘孔荣; 张一�; 张海; 张存义
Original assignee: Peijia Medical Technology Suzhou Co ltd
Current assignee: Peijia Medical Technology Suzhou Co ltd
Priority date: 2020-05-14
Filing date: 2020-05-14
Publication date: 2024-02-23
Anticipated expiration: 2040-05-14
Also published as: CN113662709A

Abstract

The present application discloses a valve stent and valve prosthesis, the valve stent comprising a valve stent body comprising interconnected leaflet and skirt struts; at least one anchoring portion connected with the valve support main body and arranged along the circumferential direction of the valve support, wherein in the unfolded state, the anchoring portion is positioned at the outer side of the valve support, and a certain interval exists between the anchoring portion and the valve support in the radial direction of the valve support; wherein the valve stent is fixed in the heart by the anchoring portion penetrating the native valve. According to the valve support, the valve support is fixed in the heart through the anchoring portion, the valve support is prevented from being shifted, the valve support is enabled to maintain a design state better, the deformation of the anchoring portion is small during release, and the feasibility of practical operation is improved.

Description

Valve stent and valve prosthesis

Technical Field

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

Background

Heart valve disease is a very common heart disease, and heart valve lesions not only endanger life safety and affect quality of life, but also bring serious burden and pressure to families and society. Currently, valve prostheses can be implanted at diseased heart valves by heart valve replacement, i.e., by interventional, minimally invasive methods, to replace the patient's original diseased heart valve. However, valve stents are prone to displacement due to the high blood flow pressure between the atrium and ventricle.

Although some techniques exist to prevent valve stents from dislodging, valve stents formed by these techniques have certain drawbacks. For example, the hooks are arranged on the upper end positioning part of the valve stent, and the valve stent is fixed by clamping heart tissue between the hooks and the upper end positioning part, but the hooks which need to be wrapped by heart tissue have quite large size, so that the deformation of the hooks is quite large in the process of releasing and compressing the valve stent, firstly, the hooks with large deformation can exert quite large force on the conveying device for loading the valve stent, the conveying device is easy to damage, secondly, the hooks cannot be released to the state of wrapping heart tissue when the valve stent is released, the requirement on the release precision is high, and the feasibility of practical operation is not high. For another example, barbs are provided on the leaflet holders, and the lower edges of the leaflets of the human body are hooked by the barbs, but in the heart cycle, the leaflet holders in such valve holders are easily subjected to the compression of the heart, so that the leaflet holders cannot maintain the design form.

Disclosure of Invention

The application provides a valve support and valve prosthesis, when fixing the valve support in the heart and preventing valve support aversion through the anchoring portion, make the better maintenance design state of valve support to deformation volume is little when releasing, improves actual operation's feasibility.

The present application proposes a valve stent comprising a valve stent body and at least one anchoring portion;

the valve stent body comprises a leaflet stent and a skirt stent which are connected with each other;

at least one anchoring part is connected with the valve support main body and is arranged along the circumferential direction of the valve support, in the unfolded state, the anchoring part is positioned at the outer side of the valve support, and a certain interval exists between the anchoring part and the valve support in the radial direction of the valve support;

wherein the valve stent is fixed in the heart by the anchoring portion penetrating the native valve.

Wherein the anchoring portion has at least one first barb for penetrating the native valve, the first barb extending radially outwardly.

Wherein the leaflet brace includes an outflow end and an inflow end, and the first barb further extends in an inflow direction along the outflow end.

Wherein, be equipped with the barb space with first barb looks adaptation on the anchoring portion, let first barb can be pressed into the barb space in.

The valve support body is provided with a hollowed-out area matched with the anchoring portion, so that the anchoring portion is embedded in the hollowed-out area when the valve support is in a compressed state.

Wherein the leaflet brace comprises an outflow end and an inflow end;

the skirt hanger further comprises a first extension connected to the leaflet hanger,

the anchoring portion extends from the first extension portion in the inflow end to the outflow end direction.

Wherein the anchoring portion also extends radially outwardly of the valve holder body;

or, the anchoring portion is parallel to the axis of the valve holder body.

Wherein the at least one first barb extends radially outwardly at a different angle; and/or the number of the groups of groups,

at least one of the anchoring portions extends radially outwardly at different angles.

The skirt bracket further comprises a tilting part extending from the free end of the first extension part to the inflow end along the outflow end, wherein the free end of the first extension part is opposite to the connecting end of the first extension part and the leaflet bracket, and the tilting part is positioned at one side of the tangent plane of the free end of the first extension part away from the inflow end.

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

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

Wherein the length of the first extension of the first skirt petals is less than the length of the first extension of the second skirt petals; and/or

The length of the turned-up parts of the petals of the first skirt edge is smaller than that of the turned-up parts of the petals of the second skirt edge; and/or

The acute angle between the first extension part of the first skirt petal and the axis of the leaflet bracket is smaller than the acute angle between the first extension part of the second skirt petal and the axis of the leaflet bracket; and/or

The acute angle between the tilted part of the first skirt petal and the axis of the leaflet bracket is smaller than the acute angle between the tilted part of the second skirt petal and the axis of the leaflet bracket.

To achieve the above object, the present application provides a valve prosthesis comprising a valve stent as described in the claims.

Wherein the valve prosthesis comprises a leakage prevention device.

Wherein the leakage preventing means comprises a wave-like ring.

Wherein the leakage preventing means comprises a connection rod for penetrating the barb portion of the native valve and connecting between the barb portions.

The skirt frame connected with the valve leaflet frame comprises at least one anchoring part arranged along the circumferential direction of the valve leaflet frame, and the valve frame is used for being fixed in the heart by penetrating into a primary valve through the anchoring part, so that the fitting degree of the valve frame and heart tissue can be improved, the axial freedom degree of the valve frame can be restrained under the tensile force of the primary valve, and the probability of displacement of the valve frame after implantation is effectively reduced; and under the unfolding state, the anchoring part is positioned at the outer side of the valve leaflet bracket, and a certain distance exists between the anchoring part and the valve leaflet bracket in the radial direction of the valve leaflet bracket, so that the anchoring part is separated from the valve leaflet bracket, the force exerted by diseased valve myocardial tissue can be transmitted to myocardial tissue by the anchoring part, the valve leaflet bracket is not influenced by the compression of diseased valve myocardial tissue and native valve leaflets in the using process of the valve leaflet bracket, and thus the valve leaflet bracket can be fixed in a heart through the anchoring part and prevented from being shifted, and the valve leaflet bracket can better maintain the design state, and further, the movement of valve leaflets on the valve leaflet bracket can not be influenced. In addition, as the anchoring part is used for penetrating the native valve to improve the fit degree of the valve support and myocardial tissue, the deformation amount required by the part penetrating the native valve is small, so that the part penetrating the native valve can be pressed back to a compressed state only by applying small force, and the part penetrating the native valve on the valve support in the conveying device can not apply too much force to the conveying device, thereby avoiding damage to the conveying device; moreover, the release precision is not required too high, the valve stent can be prevented from shifting through the anchoring part in the actual manufacturing process, and the feasibility of the actual manufacturing is ensured.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

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

FIG. 2 is a schematic perspective view of the anchoring portion and barbs in the valve stent of FIG. 1;

FIG. 3 is a detailed view of the location of anchors in a valve stent of the present application;

FIG. 4 is a schematic illustration of the positional relationship of the anchoring portion and the leaflet brace of the present application;

FIG. 5 is a schematic structural view of a valve stent of the present application in a compressed state;

FIG. 6 is a schematic view of the structure of the anchoring portion and barbs in the valve stent of the present application;

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

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

FIG. 9 is a schematic view of an embodiment of a valve prosthesis of the present application;

FIG. 10 is a schematic illustration of the implantation of a valve prosthesis of the present application into a heart;

FIG. 11 is a schematic view of an embodiment of a leak prevention device in a valve prosthesis of the present application;

FIG. 12 is a schematic view of a valve prosthesis according to one embodiment of the present application in a theoretical use state;

FIG. 13 is a schematic view showing the actual use of the valve prosthesis according to one embodiment of the present application;

FIG. 14 is a schematic view of a valve prosthesis according to another embodiment of the present application in a theoretical use state;

FIG. 15 is a schematic view showing the actual use of a valve prosthesis according to another embodiment of the present application;

FIG. 16 is a schematic view from a perspective of another embodiment of a leak prevention device in a valve prosthesis of the present application;

FIG. 17 is another schematic view from another perspective of another embodiment of a leak prevention device in a valve prosthesis of the present application;

FIG. 18 is a schematic illustration of the fit of a leak-proof device and a valve holder in a valve prosthesis of the present application;

FIG. 19 is a schematic view of the configuration of the barbs in the valve prosthesis of the present application;

fig. 20 is a detailed parametric view of the barbs in the valve prosthesis of the present application.

FIG. 21 is a schematic view of a further embodiment of a leak prevention device in a valve prosthesis of the present application;

FIG. 22 is a schematic view of a connection between the leak-proof device and the valve holder of the present application;

FIG. 23 is a schematic view of the structure of the connecting rod in the valve prosthesis of the present application;

FIG. 24 is a schematic view of another embodiment of a leak-proof device and valve holder of the present application;

Detailed Description

The following description of the technical solutions in the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings in the embodiments of the present application, and it is apparent that the described embodiments are only some embodiments of the present application, not all embodiments. All other embodiments, which can be made by one of ordinary skill in the art based on the embodiments herein without making any inventive effort, are intended to be within the scope of the present application.

Referring to fig. 1, fig. 1 is a schematic structural diagram of an embodiment of a valve stent 100 according to the present application.

The valve stent 100 includes a valve stent body.

The valve holder body comprises a leaflet holder 110 and a skirt holder 120 connected to each other. The skirt hanger 120 and the leaflet hanger 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 of the memory metal may be automatically expanded from a compressed state.

The leaflet brace 110 is 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 brace 110 can also be provided with mounting and positioning holes that can facilitate positioning and mounting of the valve.

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

In this embodiment, the leaflet brace 110 can include an outflow end 112 and an inflow end 111. In the deployed state, the inflow end 111 is upstream in the blood flow direction of the outflow end 112.

Specifically, the skirt hanger 120 may extend from the inflow end 111 in a direction away from the leaflet hanger 110, and more specifically, the skirt hanger 120 may extend from an end of the leaflet hanger 110 away from the auxiliary element 130. Also, the leaflet brace 110 and skirt brace 120 may be a circular arc transition connection, or even a large circular arc transition connection.

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

Wherein, the valve support further includes at least one anchoring portion 123 disposed along the circumference of the valve leaflet support 110, and the at least one anchoring portion 123 is connected with the valve support main body, so that the valve support 100 is fixed in the heart by penetrating the native valve through the anchoring portion 123, the fitting degree of the valve support 100 and the heart can be improved, the axial freedom degree of the valve support 100 can be restrained under the tensile force of the native valve, and the probability of displacement of the valve support 100 after implantation is effectively reduced. In addition, in the expanded state, the anchoring portion 123 is located outside the leaflet support 110, and a certain distance exists between the anchoring portion 123 and the leaflet support 110 in the radial direction of the leaflet support 110, so that the anchoring portion 123 and the leaflet support 110 are separated, and the leaflet support 110 is not influenced by the compression of diseased valve myocardial tissue and native leaflets in the use process, so that the design state can be better maintained, and the movement of the leaflets on the leaflet support 110 is not influenced. The first barb 124 penetrating the native valve is arranged on the anchoring portion 123, because the first barb 124 penetrating the native valve through the first barb 124 of the anchoring portion 123 improves the fitting degree of the valve holder 100 and myocardial tissue, the deformation amount required by the first barb 124 penetrating the native valve is small, so that the first barb 124 penetrating the native valve can be pressed back to a compressed state only by applying small force, and thus the first barb 124 penetrating the native valve on the valve holder 100 in the conveying device cannot apply too much force to the conveying device, and damage to the conveying device is avoided. Moreover, the release precision is not required too high, so that the valve stent 100 can be prevented from being shifted through the anchoring part 123 in the actual manufacturing process, and the feasibility of the actual manufacturing is ensured. Wherein the anchoring portion 123 may be linear, curved or otherwise shaped.

To enable the first barbs 124 to more conveniently penetrate the native valve, at least a portion of the first barbs 124 may extend radially outward of the leaflet brace 110. Preferably, the portion of the first barb 124 that penetrates the native valve is formed to extend radially outward of the leaflet brace 110. The angles at which the at least one first barb 124 extends radially outward may or may not be the same.

Additionally, the first barb 124 may extend along the outflow end 112 toward 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. 6, the anchoring portion 123 may be provided with a barb space 125 adapted to the first barb 124, so that the first barb 124 can be pressed into the barb space 125, and thus, when the valve stent 100 is in a compressed state, the first barb 124 is embedded in the barb space 125, and the first barb 124 is layered with the anchoring portion 123, so that the valve stent 100 can be more easily loaded into the delivery device. Alternatively, the first barb 124 is cut from the anchor 123.

The length h of the first barb 124 is 2mm to 12mm. The length h of the first barb 124 may refer to the length of the line between the end point of the end of the first barb 124 that is connected to the anchor 123 and the end point of the end of the first barb 124 that is remote from the anchor 123. Preferably, the length h of the first barb 124 is 2 mm-3 mm, so that the first barb 124 will not easily slip after hanging tendons and tissues thereof in the heart valve, and the first barb 124 will not prick into heart tissues to cause vascular injury and puncture.

Specifically, the angle d between the first barb 124 and the anchor 123 may be 30 ° to 40 °, or 50 ° to 70 °. Preferably, the included angle d between the first barb 124 and the anchoring portion 123 may be 50 ° to 60 °, which may more easily catch heart tissue, and the first barb 124 may not puncture the delivery device or increase the resistance to sheath penetration as the valve stent 100 enters the corresponding delivery device.

The thickness e of the first barb 124 may be 0.2mm to 0.5mm. Preferably, the thickness e of the first barb 124 may be 0.2mm to 0.3mm, so that a good supporting force of the first barb 124 may be maintained. In this embodiment, the first barbs 124 may be of uniform thickness (the distal end may be eliminated), and the thickness e of the first barbs 124 may be the thickness excluding the distal end.

The width f of the first barb 124 may be 0.2mm to 0.6mm. Preferably, the width f of the first barb 124 is 0.2mm to 0.4mm, such that the ratio of the width f to the thickness e of the first barb is between 2/3 and 2, allowing for a more stable configuration of the first barb 124 and providing better support.

One or more first barbs 124 may be provided on each anchor 123. The spacing distance g between the corresponding barb voids 125 of two adjacent first barbs 124 may be 1.5-9mm. Considering the characteristics of the heart anatomy, 1.5-3mm is recommended, and the reasonable length h and spacing g of the first barbs 124 will not allow for optimal structural design due to the limited chordal tissue anchoring distance 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 the 3 first barbs 124 can enable the valve stent 100 to obtain reasonable length and anchoring force, and improve the bonding strength of the first barbs 124 and the native valve, so as to maintain the stability and the anti-displacement performance of the valve stent 100.

In this embodiment, to prevent the first barb 124 from abrading the surrounding tissue, the distal end of the first barb 124 may be passivated or rounded.

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

The first extension portion 121 and the anchoring portion 123 may be in a circular arc transitional connection. As can be seen from the anatomical structure, the heart tissue will exert radial pressure on the valve holder 100 at the circular arc transition between the anchoring portion 123 and the first extension portion 121 of the skirt holder 120; at this time, the part is deformed correspondingly, and because the skirt bracket 120 and the leaflet bracket 110 are in large arc transitional connection, the leaflet in the leaflet bracket 110 is restrained by surrounding tissues to deform less, the function of the leaflet is not affected greatly, and paravalvular leakage caused by incomplete valve closure is avoided.

As shown in fig. 2, the anchor 123 includes an anchor root, which is an end of the anchor 123 near the first extension 121, and an anchor tip, which is an end of the anchor 123 far from the first extension 121. It will be appreciated that there may be a variety of positional relationships between the anchoring portion 123 and the leaflet brace 110, such as the anchoring portion 123 being parallel to the axis of the valve brace body; also for example, the anchoring portion root is closer to the axis of the valve holder body than the anchoring portion top, i.e. the anchoring portion 123 extends radially outwardly of the valve holder body from the first extension 121, although not limited thereto. In addition, the angle at which the at least one anchoring portion 123 extends radially outward may be the same, or may be different.

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

Further, as shown in fig. 3, an included angle a exists between the anchoring portion 123 and the first extension portion 121. Preferably, a is 120 °, although not limited thereto, and a may be other values. An angle b exists between the first extension 121 and the leaflet brace 110. The final position of the anchor 123 will be determined from a and b in combination.

It will be appreciated that, as shown in fig. 4, when the valve stent 100 is in the deployed state, a certain distance c exists between the anchoring portion 123 and the leaflet stent 110, and the anchoring portion root is at a distance from the leaflet stent 110, i.e., the anchoring portion 123 and the leaflet stent 110 are separated. Alternatively, the anchoring portion 123 may be extended from a middle portion of the first extension portion 121.

In addition, the anchoring portion 123 does not touch the leaflet brace 110 during the cardiac cycle, so that the anchoring portion 123 can be prevented from interfering with the leaflet brace 110, so that the leaflet brace 110 can maintain the design form well.

In addition, as shown in fig. 5, the valve stent body is provided with a hollowed-out area 113 matched with the anchoring portion 123, so that when the valve stent 100 is in a compressed state, the anchoring portion 123 is embedded in the hollowed-out area 113 and is positioned on the same circumferential surface as the valve stent body, and the valve stent 100 is more easily loaded into the conveying device. As shown in fig. 1, when the valve stent 100 is in the expanded state, the anchoring portion 123 and the leaflet stent 110 are coaxial but located on different circumferential surfaces, and the distance between the anchoring portion 123 and the axis of the leaflet stent 110 is greater than the radius of the leaflet stent 110, so that the anchoring portion 123 and the native valve tissue are in contact, allowing the leaflet stent 110 to maintain a relatively stable structure. To obtain the valve stent 100, a tubular object made of memory metal may be cut to obtain the valve stent 100 shown in fig. 5, and the valve stent 100 shown in fig. 5 may be processed to bring the valve stent 100 into a deployed state, so as to obtain the valve stent 100 capable of being switched between the deployed state and the compressed state.

Further, the skirt hanger 120 may further comprise a turn 122 extending from the free end of the first extension 121 in the direction of the outflow end 112 towards the inflow end 111. Wherein the free end of the first extension 121 is opposite to the connection end of the first extension 121 and the leaflet brace 110. The tilted portion 122 is located on a side of the tangential plane to the free end of the first extension 121 away from the inflow end 111. The first extending part 121 and the raising part 122 can be in arc transitional connection, so that the connection part of the first extending part 121 and the raising part 122 can be ensured to be a smooth arc surface, and the connection part of the first extending part 121 and the raising part 122 is prevented from stabbing heart myocardial tissues. As shown in fig. 4, even the first extension portion 121 and the raised portion 122 are connected in a large arc transition.

A certain included angle can be formed between the tilting part 122 and the first extending part 121, so that the first extending part 121 is prevented from extending out to stab heart myocardial tissue, and the heart myocardium is prevented from being stimulated, and the normal function of the heart is prevented from being influenced.

In this embodiment, as shown in fig. 7, the valve stent 100 as a whole may be generally flower-shaped, and the skirt stent 120 may be seen to include a plurality of petal-like structures, which may be referred to as skirt petals, i.e., the skirt stent 120 may include a plurality of skirt petals. Specifically, the number of skirt petals in the skirt hanger 120 can be 6 to 13. Preferably, the total number of skirt petals may be between 6 and 10, which may better conform to heart myocardial tissue without increasing the resistance of the valve stent 100 to entry into the sheath.

Wherein each skirt petal may include a first extension 121 and a kick 122 connected in sequence. Also, the first extension 121 may be the end of the skirt petals near the leaflet brace 110. Specifically, the raised portion 122 may have an arc shape, wherein the arc radius of the raised portion 122 may be 1-3mm. Preferably, the radius of the arc of the tilting portion 122 may be 1-2mm, which may better fit the anatomical structure of the heart, preventing the valve holder 100 from moving under conditions 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 forms a similar "D" or "C" shape structure, and the outline of the native annulus attached to the native valve of the heart of a human body is similar to the "D" or "C" shape structure, thus the skirt stent 120 can better conform to the outline of the native annulus, more facilitate to conform to the real mitral anatomy, reduce the compression on the aorta, and thereby prevent perivalvular leakage.

Specifically, the difference in length and/or angle of the first extension 121 and the kick portion 122 of the first skirt petals 126 may be made from the length and/or angle of the first extension 121 and the kick portion 122 of the second skirt petals 127; the first skirt petals 126 are made smaller in size in the radial direction of the leaflet brace 110 than the second skirt petals 127.

For example, as shown in fig. 8, the length of the first extension 121 of the first skirt petals 126 is less than the length of the first extension 121 of the second skirt petals 127.

For another example, the length of the turned-up portions 122 of the first skirt petals 126 is smaller than the length of the turned-up portions 122 of the second skirt petals 127.

For another example, the acute angle i of the first extension 121 of the first skirt petals 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 petals 127 to the axis of the leaflet brace 110.

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

In summary, the skirt stent 120 connected with the leaflet stent 110 of the present application includes at least one anchoring portion 123 disposed along the circumferential direction of the leaflet stent 110, and the valve stent 100 is used for being fixed in the heart by the anchoring portion 123 penetrating into the native valve, so that the fitting degree of the valve stent 100 and the heart can be improved, the axial freedom degree of the valve stent 100 can be restrained under the tensile force of the native valve, and the probability of displacement of the valve stent 100 after implantation is effectively reduced; and in the unfolded state, the anchoring part 123 is positioned at the outer side of the valve leaflet support 110, and a certain distance exists between the anchoring part 123 and the valve leaflet support 110 in the radial direction of the valve leaflet support 110, so that the valve leaflet support 110 is separated from the valve leaflet support 110 in the use process, and is not influenced by the compression of diseased valve myocardial tissues and native valve leaflets, and therefore, the valve leaflet support 110 can better maintain the design state while the valve leaflet support 100 is fixed in the heart through the anchoring part 123 and the valve leaflet support 100 is prevented from being shifted, and further, the activity of the valve leaflets on the valve leaflet support 110 is not influenced. In addition, since the anchoring portion 123 is used to pierce the native valve to improve the adhesion between the valve stent 100 and the myocardial tissue, the deformation amount required for the portion pierced with the native valve is small, so that the portion pierced with the native valve can be pressed back to the compressed state with a small force, and thus the portion pierced with the native valve on the valve stent 100 located in the delivery device does not exert too much force on the delivery device, and damage to the delivery device is avoided. Moreover, the release precision is not required too high, so that the valve stent 100 can be prevented from being shifted through the anchoring part 123 in the actual manufacturing process, and the feasibility of the actual manufacturing is ensured.

Further, as shown in fig. 9, the present application also proposes a valve prosthesis 200, the valve prosthesis 200 comprising the valve stent 100 of the above-described embodiment.

Optionally, the valve prosthesis 200 further comprises a leakage prevention device to improve the leakage prevention performance of the valve prosthesis 200, so that paravalvular leakage caused by the release of the valve stent 100 can be avoided. As shown in fig. 10, the leak-proof device 210 and the valve holder 100 may be mated to form a valve prosthesis 200 for implantation into the heart.

It will be appreciated that the containment device 210 and the valve holder 100 may be manufactured separately and then mated by interconnection.

The leakage preventing device 210 has a ring structure and is sleeved on the periphery of the leaflet bracket 110.

As shown in fig. 11, the leakage preventing means 210 may have a wavy annular structure. It is understood that the shape of the leakage preventing device 210 is not limited thereto, and for example, the leakage preventing device 210 may also have a zigzag ring-shaped structure.

As shown in fig. 12, in theory, in a round-like vessel or valve tissue, the valve prosthesis 200 does not conform well to the vessel or valve tissue due to the limited number of anchoring portions 123. Theoretically, more anchor portions 123 can achieve a better fitting state, but the number of anchor portions 123 cannot be too large due to a manufacturing process or the like. And as shown in fig. 13, in the actual use process, since the shape of the tissue such as the mitral valve is not a regular circle, the valve support 100 affects the leaflet support 110 during the use process, and thus affects the normal operation of the leaflet in the normal cardiac cycle.

To solve the above-mentioned problem of how to make the valve prosthesis 200 better fit the blood vessel or the valve tissue in the case that the number of the anchoring portions 123 is insufficient, as shown in fig. 14, by providing at least one support structure on the leakage preventing device 210 and connecting the leakage preventing device 210 to the valve stent 100 to provide more support points in the circumferential direction, better radial support force and anchoring force can be provided in cooperation with the valve stent 100, so that the valve prosthesis 200 better fits the round-like blood vessel or the valve structure. Further, as shown in fig. 15, by providing at least one support structure on the leakage preventing device 210, even in the mitral valve region, since the leakage preventing device 210 provides more radial force and more anchoring force, it can be more closely attached to the valve tissue, the influence of the heart tissue on the leaflet holder 110 can be reduced, and the leaflet holder 110 can be maintained in a design form well.

Wherein the support structure may be located anywhere on the containment device 210, such as at the peaks or troughs of a wavy annular containment device.

It will be appreciated that the support structure may be a barb 211, as shown in fig. 16, such that the barb 211 on the containment device 210 cooperates with the first barb 124 on the anchor 123 to provide more radial support force to better maintain the design configuration of the leaflet brace 110.

Alternatively, as shown in fig. 17, the height of the barb 211 is o. Preferably, o is 4-10mm, the barb 211 provides structural design space for the second barb 2112 and allows reasonable distribution of the radial force of the leakage prevention device 210.

With continued reference to fig. 9, each barb 211 may be disposed between two adjacent anchors 123 to provide more radial support points for better securing the valve holder 100 in cooperation with the first barb 124 on the anchor 123. It is understood that the number of the barbs 211 may be equal to the number of the anchors 123, and at this time, as shown in fig. 1 and 18, the barbs 211 and the anchors 123 of the valve holder 100 may be uniformly distributed in the circumferential direction.

As shown in fig. 19, the barb 211 includes a frame 2111 and a second barb 2112, and a receiving hole 2113 provided in the frame 2111. The receiving hole 2113 provides a space for receiving the second barb 2112, and the structural arrangement of the receiving hole 2113 will provide better radial support force in cooperation with the valve stent 100, as well as provide suitable anchoring force, and can reduce the axial shrinkage of the leakage preventing device 210 during assembly to the corresponding sheath and release, providing better release accuracy for the valve stent 100 and leakage preventing device 210.

Wherein each barb 211 may have one or more second barbs 2112 thereon. The number of second barbs 2112 provided on one barb 211 may be 1-5, which is a recommended number of 2. The 2 second barbs 2112 may provide a more reasonable length and anchoring force to enhance the bond strength of the valve prosthesis 200 to the myocardial tissue. As shown in fig. 19, one barb 211 may include two second barbs 2112, namely a top second barb and a bottom second barb.

As shown in fig. 20, the length p of second barb 2112 is 2mm to 12mm. The length p of the second barb 2112 in this application refers to the distance from the end of the second barb 2112 that is connected to the frame 2111 and the end of the second barb 2112 that is remote from the frame 2111, the second barb 2112 being angled with respect to the frame 2111. Preferably, the length p of the second barbs 2112 is 2 mm-3 mm, so that the second barbs 2112 cannot easily slip after hanging myocardial tissue in the heart valve, and vascular injury and puncture caused by the second barbs 2112 penetrating into the native valve cannot occur.

The angle q of second barb 2112 and frame 2111 is 30 ° to 40 °, or 50 ° to 70 °. Preferably, the angle q is 50-60, such that the second barbs 2112 more easily grip the heart tissue and the second barbs 2112 do not puncture or increase the resistance to entry into the delivery device when the valve prosthesis 200 is advanced into the corresponding delivery device.

The second barb 2112 has a width s of 0.2mm to 0.5mm. Preferably 0.2mm to 0.3mm, the holding force of the second barbs 2112 is kept good.

The thickness of second barb 2112 is r and is 0.2mm to 0.6mm. Preferably, r is 0.2mm to 0.4mm, such that the thickness r and width s ratio of the second barb 2112 is between 2/3 and 2, which facilitates a more stable barb configuration and provides better support.

The spacing distance between the corresponding receiving holes 2113 of two adjacent second barbs 2112 on the same barb 211 is t.

Wherein the aspect ratio of the second barbs 2112 and the aspect ratio of the first barbs 124 may be different or the same. Such as by adjusting the length, angle, or thickness of the second barbs 2112 to provide greater structural anchoring force to the second barbs 2112, to supplement insufficient anchoring force of the valve stent 100.

Among them, as shown in fig. 16 and 21, a structure on the leakage preventing device 210 for connecting the adjacent two barb portions 211 may be referred to as a connection rod 212.

The connecting rod 212 may have various shapes such as V-shape or sine wave.

In the present embodiment, please continue to refer to fig. 17, the height of the connecting rod 212 is n. Preferably, n is 5-7mm, and the height n of the connecting rod 212 needs to reasonably match the length of the anchoring portion 123 of the valve holder 100, so it cannot be too long or too short.

Alternatively, as shown in fig. 22, the leakage preventing device 210 may be connected to the valve stent 100 through a connecting rod 212, so as to prevent the leakage preventing device 210 from being displaced during use. Wherein the connecting rod 212 may be connected to the valve stent 100 by welding, stitching, adhesive, etc. Preferably, the connecting rod 212 may be connected to the anchoring portion 123, so that the leakage preventing device 210 may be connected to the anchoring portion 123 by the connecting rod 212 to provide more radial supporting force in cooperation with the first barb 124 on the anchoring portion 123, so that the leaflet brace 110 can be better connected to the native valve by cooperation with the first barb 124, and maintain the design form. Further, as shown in fig. 23, the connecting rod 212 may be provided with a process hole 213, wherein the process hole 213 and the corresponding hole of the anchoring portion 123 may be connected by a suture.

Preferably, as shown in fig. 22, the leakage prevention device 210 is located between the anchoring portion 123 and the leaflet brace 110.

In addition, as shown in fig. 24, the leakage preventing means 210 may be further located at a side of the anchoring portion 123 remote from the leaflet brace 110.

As shown in fig. 17, the leakage preventing means 210 has an overall height of m. Preferably, m is 10-15mm, and the value of m is related to the length of the anchoring portion 123 of the valve stent 100 and the actual valve anatomy. The overall height of the leakage prevention device 210 is less than the length of the anchoring portion 123 of the valve holder 100, and additionally allows for the distance that the corresponding valve can be anchored.

Alternatively, as shown in fig. 18, the distance between the leakage prevention device 210 and the leaflet brace 110 can be u. u may be 1mm-8mm. Preferably, u is 2mm-4mm so that the leakage prevention device 210 can better fit the anchoring portion 123 of the valve holder 100.

The valve prosthesis 200 may also include leaflets. The leaflets may be located within the valve holder 100 and fixedly connected to the valve holder 100. The leaflet may be composed of a thin layer of material (typically a layer of biological film) that is movable when blood flows. The number of leaflet arrangements can be two or more. Of course, the valve prosthesis 200 may also include a one-way valve disposed within the valve holder 100, which may be used to block blood regurgitation.

The foregoing is only the embodiments of the present application, and not the patent scope of the present application is limited by the foregoing description, but all equivalent structures or equivalent processes using the contents of the present application and the accompanying drawings, or directly or indirectly applied to other related technical fields, which are included in the patent protection scope of the present application.

Claims

1. A valve stent, the valve stent comprising:

a valve stent body comprising a leaflet stent and a skirt stent that are interconnected;

at least one anchoring portion connected to the valve support main body, disposed along a circumferential direction of the leaflet support, and located outside the leaflet support in a deployed state with a certain interval from the leaflet support in a radial direction of the leaflet support; the anchoring portion having at least one first barb for penetrating the native valve, the first barb extending radially outwardly; the anchoring part is provided with a barb gap matched with the first barb, so that the first barb can be pressed into the barb gap;

the valve support comprises a valve support body, an anchoring part and a hollow area, wherein the valve support body is provided with the hollow area matched with the anchoring part, so that the anchoring part is embedded in the hollow area when the valve support is in a compressed state; the valve stent is secured within the heart by the anchoring portion penetrating the native valve.

2. The valve stent of claim 1, wherein the leaflet stent comprises an outflow end and an inflow end, the first barb further extending along the outflow end in a direction toward the inflow end.

3. The valve stent of claim 1, wherein the leaflet stent comprises an outflow end and an inflow end;

4. The valve stent of claim 1, wherein the anchor portion further extends radially outward of the valve stent body;

or, the anchoring portion is parallel to the axis of the valve holder body.

5. The valve stent of claim 1, wherein the valve stent comprises,

at least one of said first barbs extending radially outwardly at different angles; and/or the number of the groups of groups,

at least one of the anchoring portions extends radially outwardly at a different angle.

6. The valve holder of claim 3, further comprising a lift extending from a free end of the first extension in a direction from the outflow end toward the inflow end, wherein the free end of the first extension is opposite the connection end of the first extension and the leaflet holder, the lift being located on a side of a tangential plane to the free end of the first extension away from the inflow end.

7. The valve stent of claim 6, wherein the skirt stent comprises at least one first skirt petal and at least one second skirt petal,

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

the length of the first extension of the first skirt petals is smaller than the length of the first extension of the second skirt petals; and/or

The length of the tilting part of the first skirt petals is smaller than that of the tilting part of the second skirt petals; and/or

The acute angle between the tilting part of the first skirt petal and the axis of the leaflet bracket is smaller than the acute angle between the tilting part of the second skirt petal and the axis of the leaflet bracket.

9. A valve prosthesis comprising a valve stent according to any one of claims 1-8.

10. The valve prosthesis of claim 9, wherein the valve prosthesis comprises a leak-proof device.

11. The valve prosthesis of claim 10, wherein the leakage prevention device comprises a wavy ring.

12. The valve prosthesis of claim 10, wherein the leakage prevention means comprises a connecting rod between a barb for penetrating the native valve and a connecting barb.