CN113662709A

CN113662709A - Valve stent and valve prosthesis

Info

Publication number: CN113662709A
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: 2021-11-19
Anticipated expiration: 2040-05-14
Also published as: CN113662709B

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 anchoring part connected with the valve support main body and arranged along the circumferential direction of the valve leaflet support, wherein in the unfolding state, the anchoring part is positioned outside the valve leaflet support, and a certain distance exists between the anchoring part and the valve leaflet support in the radial direction of the valve leaflet support; wherein the valve stent is fixed within the heart by the anchoring portion penetrating into the native valve. The valve support is fixed in the heart through the anchoring part, the valve support is prevented from shifting, the valve support is enabled to maintain the design state better, deformation of the anchoring part is small when the valve support is released, and feasibility of actual operation is improved.

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 heart valve disease is a very common heart disease, and the heart valve pathological changes 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 application provides a valve support and a valve prosthesis, which can better maintain the design state of the valve support while fixing the valve support in the heart through an anchoring part and preventing the valve support from shifting, and have small deformation amount during release, thereby improving the feasibility of actual operation.

To solve the above technical problem, the present application proposes a valve stent including a valve stent main body and at least one anchoring portion;

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

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

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

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

Wherein, the valve leaflet bracket comprises an outflow end and an inflow end, and the first barbs also extend along the outflow end to the inflow end.

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

The valve support main body is provided with a 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.

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

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

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

Wherein the anchoring portion further extends radially outward of the valve stent body;

alternatively, the anchoring portion is parallel to the axis of the valve stent body.

Wherein at least one first barb extends radially outwardly at a different angle; and/or the presence of a gas in the gas,

the at least one anchoring portion extends radially outwardly at different angles.

The skirt stent further comprises a tilting part extending from the free end of the first extension part along the flow-out end to the flow-in end direction, wherein the free end of the first extension part is opposite to the connecting end of the first extension part and the leaflet stent, and the tilting part is positioned on one side of the tangent plane of the free end of the first extension part, which is far away from the flow-in end.

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.

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 tilting part of the first skirt petal is smaller than that of the tilting part of the second skirt petal; and/or

An acute included angle between the first extension part of the first skirt-edge petal and the axis of the valve leaflet bracket is smaller than an acute included angle between the first extension part of the second skirt-edge petal and the axis of the valve leaflet bracket; and/or

The acute angle included angle between the tilting part of the first skirt-edge petal and the axis of the valve leaflet support is smaller than the acute angle included angle between the tilting part of the second skirt-edge petal and the axis of the valve leaflet support.

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

Wherein the valve prosthesis comprises a leak protection device.

Wherein the leakage preventing means comprises a wavy ring.

Wherein, leak protection device is including being used for piercing the native valve barb portion and connecting the connecting rod between the barb portion.

The skirt stent connected with the valve leaflet stent comprises at least one anchoring part arranged along the circumferential direction of the valve leaflet stent, the valve stent is used for being fixed in a heart by penetrating a native valve through the anchoring part, the fitting degree of the valve stent and heart tissues can be improved, the axial degree of freedom of the valve stent can be bound under the pulling force of the native valve, and the probability of displacement of the valve stent after implantation is effectively reduced; and under the expansion state, the anchoring part is located the leaflet support outside, and anchoring part and leaflet support have certain interval in the radial direction of leaflet support, make anchoring part and leaflet support separate, anchoring part can conduct the valve cardiac muscle tissue application of pathological change to cardiac muscle tissue, let the leaflet support not receive the oppression influence of the valve cardiac muscle tissue of pathological change and native leaflet in its use, can fix valve support in the heart and prevent valve support aversion through the anchoring part like this, make better maintenance design state of leaflet support, and then can not cause the influence to the activity of leaflet on the leaflet support. In addition, the native valve is penetrated through the anchoring part to improve the fit between the valve stent and myocardial tissue, and the deformation quantity of the part penetrated into the native valve is small, so that the part penetrated into the native valve can be pressed back to a compressed state by applying small force, and the part penetrated into the native valve on the valve stent in the delivery device can not apply too much force on the delivery device, thereby avoiding damaging the delivery device; and the release precision is not required to be too high, the valve stent can be prevented from being displaced 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 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 the anchoring portion and barbs of the valve stent of FIG. 1;

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

fig. 4 is a schematic view of the positional relationship of the anchoring portion and the leaflet braces of the present application;

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

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

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

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 structural view of an embodiment of a valve prosthesis of the present application;

FIG. 10 is a schematic view of the present application with a valve prosthesis implanted in a heart;

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

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

FIG. 13 is a schematic view of a valve prosthesis according to an embodiment of the present application in an actual use state;

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 of a valve prosthesis according to another embodiment of the present application in an actual use state;

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

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

FIG. 18 is a schematic view of the fit of the leak protection device and the valve stent of the present invention;

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

FIG. 20 is a detailed view of the parameters of the barbs in the valve prosthesis of the present application.

FIG. 21 is a schematic view of a leak protection device of a valve prosthesis according to the present application;

FIG. 22 is a schematic view of a connection between the leak protection device and a valve stent of the present application;

FIG. 23 is a schematic view of the attachment bar of the valve prosthesis of the present application;

FIG. 24 is a schematic view of another attachment of the leak protection device of the present application to a valve stent;

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.

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 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 may also be provided with positioning holes for positioning and mounting the valve.

In addition, the end of the leaflet holders 110 distal from the skirt holders 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 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.

The valve stent further comprises at least one anchoring part 123 arranged along the circumferential direction of the leaflet stent 110, wherein the at least one anchoring part 123 is connected with the valve stent main body, so that the valve stent 100 is fixed in the heart by penetrating into the native valve through the anchoring part 123, the fitting degree of the valve stent 100 and the heart can be improved, the axial degree of freedom of the valve stent 100 can be restrained under the pulling force of the native valve, and the probability of displacement of the valve stent 100 after implantation is effectively reduced. In addition, in the deployed state, the anchor portion 123 is located outside the leaflet support 110, and there is a certain distance between the anchor portion 123 and the leaflet support 110 in the radial direction of the leaflet support 110, so that the anchor portion 123 and the leaflet support 110 are separated, and thus the leaflet support 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 support 110 is not affected. Be equipped with the first barb 124 that is used for stabbing native valve on anchor portion 123, because the first barb 124 through anchor portion 123 pierces native valve and improves valve support 100 and the laminating degree of myocardial tissue, the deformation volume that the first barb 124 that pierces native valve needs is little to only need exert less power and just can press the first barb 124 that pierces native valve back to the compression state, be located like this and exert too much power to conveyor by the first barb 124 that pierces native valve on valve support 100 in the conveyor, avoid causing the damage to conveyor. In addition, the release accuracy is not required to be high, the valve stent 100 can be prevented from shifting through the anchoring part 123 in the actual manufacturing process, and the feasibility of the actual manufacturing is ensured. The anchoring portion 123 may be a straight line, a curved line, or other shapes.

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. Wherein the angle at which the at least one first barb 124 extends radially outward may be the same, but may not be the same.

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. 6, the 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, so that 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 is in the same layer as the anchoring portion 123, so that the valve stent 100 can be more easily loaded into the delivery device. Optionally, first barbs 124 are cut from anchoring 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 line connecting an end point of an end of the first barb 124 connected to the anchor portion 123 and an end point of an end of the first barb 124 far from the anchor 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 being hooked on the tendon and the tissue thereof in the heart valve, and the phenomenon that the first barb 124 punctures the heart tissue to cause blood vessel damage and puncture does not occur.

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

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), and the thickness e of the first barb 124 may be 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 provided on each 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 may be blunted or radiused.

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 anchor portion 123 may extend from the first extension 121 in a direction from the inflow end 111 to the outflow end 112.

Wherein, the first extension 121 and the 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 anchoring part 123 and the first extension 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. 2, the anchor 123 includes an anchor root portion and an anchor tip portion, wherein the anchor root portion is an end portion of the anchor 123 close to the first extension 121, and the anchor tip portion is an end portion of the anchor 123 far from the first extension 121. It is understood that there can be a variety of positional relationships between the anchor 123 and the leaflet stent 110, such as the anchor 123 being parallel to the axis of the valve stent body; also for example, the anchor root is closer to the axis of the valve stent body than the anchor tip, i.e. the 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 anchoring portion 123 extends radially outward may be the same, and of course, may not be the same.

Among these, the solution in which the root of the anchoring portion is closer to the axis of the leaflet frame 110 is preferable because such a positional relationship allows the valve frame 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 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 anchor 123 will be determined based on a and b in combination.

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

In addition, the anchoring portions 123 do not touch the leaflet holder 110 during the cardiac cycle, which prevents the anchoring portions 123 from interfering with the leaflet holder 110 and allows the leaflet holder 110 to maintain the design form well.

In addition, as shown in fig. 5, the valve stent body is provided with a hollow-out area 113 adapted to the anchoring portion 123, so that when the valve stent 100 is in a compressed state, the anchoring portion 123 is embedded in the hollow-out area 113 and is located on the same circumferential surface as the valve stent 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 anchoring portion 123 and the leaflet stent 110 are coaxial but are 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 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 shown in fig. 5 can be obtained by cutting a tubular body made of memory metal, and the valve stent 100 shown in fig. 5 is processed to make the valve stent 100 in the expanded state, so as to obtain the valve stent 100 which can be 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 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 the anchoring portion 123 penetrating into the native valve, so that 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 in the expanded state, the anchor portion 123 is located outside the leaflet support 110, and there is a certain interval between the anchor portion 123 and the leaflet support 110 in the radial direction of the leaflet support 110, so that the anchor portion 123 and the leaflet support 110 are separated, and the leaflet support 110 is not affected by the pressure of diseased valve myocardial tissue and native leaflets during the use process, so that the design state of the leaflet support 110 can be better maintained while the valve support 100 is fixed in the heart through the anchor portion 123 and the valve support 100 is prevented from shifting, and further, the movement of the leaflets on the leaflet support 110 cannot be affected. In addition, because the 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, the valve stent 100 can be prevented from shifting 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 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. 10, 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.

It is understood that the leak protection device 210 and the valve stent 100 can be manufactured separately and then used in cooperation by being connected to each other.

The anti-leakage device 210 is of 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 means 210 is not limited thereto, and for example, the leakage preventing means 210 may also be a zigzag annular structure.

As shown in fig. 12, in a theoretically roundish-like vessel or valve tissue, the valve prosthesis 200 cannot be better fitted with the vessel or valve tissue due to the limited number of anchoring portions 123. Theoretically, more anchor portions 123 can achieve a better fit state, but the number of anchor portions 123 cannot be too large due to a manufacturing process or the like. Also, as shown in fig. 13, in actual use, since the shape of the tissue such as the mitral valve is not a regular circle, the valve stent 100 may affect the leaflet stent 110 and thus the normal operation of the leaflets in the normal cardiac cycle during use.

To solve the above-mentioned problem of "how to make the valve prosthesis 200 better fit with the blood vessel or valve tissue under the condition of insufficient number of the anchoring portions 123", as shown in fig. 14, by providing at least one support structure on the leakage prevention device 210 and connecting the leakage prevention device 210 with the valve stent 100 to provide more support points in the circumferential direction, better radial support force and anchoring force can be provided by matching with the valve stent 100, so that the valve prosthesis 200 can better fit with the roundabout or valve structure. Moreover, as shown in fig. 15, by providing at least one support structure on the leak preventer 210, even in the mitral valve region, the leak preventer 210 provides more radial force, provides more anchoring force, can better conform to valve tissue, can reduce the influence of heart tissue on the leaflet stent 110, and can allow the leaflet stent 110 to better maintain the design form.

Wherein the support structure can be arranged anywhere in the leak protection 210, for example in the wave-like peaks or troughs of a ring-shaped leak protection.

It is understood that the support structure can be a barb 211, as shown in fig. 16, such that the barb 211 on the leak preventer 210 provides more radial support force in cooperation with the first barb 124 on the anchor portion 123, resulting in better maintenance of the design configuration of the leaflet brace 110.

Alternatively, as shown in fig. 17, the height of the barb 211 is o. Preferably, o recommends 4-10mm, the barbed portion 211 provides a structural design space for the second barb 2112, and the radial force of the leak preventer 210 can be reasonably distributed.

With continued reference to fig. 9, each barb 211 may be disposed between two adjacent anchoring portions 123 to provide more radial support points for better securing the valve stent 100 with the first barbs 124 on the anchoring portions 123. It will be appreciated that the barbs 211 may be provided in an equal number to the number of the anchors 123, and in this case, as shown in fig. 1 and 18, the barbs 211 and the anchors 123 of the valve stent 100 may be evenly distributed in the circumferential direction.

As shown in fig. 19, the barbed portion 211 includes a frame 2111 and a second barb 2112, and a receiving hole 2113 provided in the frame 2111. The receiving holes 2113 provide space for receiving the second barbs 2112, and the receiving holes 2113 are configured to provide better radial support in conjunction with the valve stent 100, provide suitable anchoring force, and reduce the axial shrinkage rate of the leak protection device 210 during fitting to a corresponding sheath and release, thereby providing better release accuracy for the valve stent 100 and the leak protection device 210.

Wherein, each barb 211 can be provided with one or more second barbs 2112. The number of the second barbs 2112 provided on one barbed portion 211 may be 1 to 5, and the recommended number thereof is 2. The 2 second barbs 2112 can obtain more reasonable length and anchoring force, and the bonding strength of the valve prosthesis 200 and myocardial tissue is improved. As shown in FIG. 19, a barbed portion 211 may include two second barbs 2112, a top second barb and a bottom second barb.

As shown in fig. 20, the length p of the second barb 2112 is 2mm to 12 mm. The length p of the second barb 2112 in this application refers to the distance between the end surface of the second barb 2112 connected to the frame 2111 and the end surface of the second barb 2112 remote from the frame 2111, the second barb 2112 being angled with respect to the frame 2111. Preferably, the length p of the second barb 2112 is 2mm to 3mm, so that the second barb 2112 cannot easily slip off after being hung on the heart valve central muscle tissue, and the situation that the second barb 2112 pierces into the native valve to cause blood vessel injury and puncture cannot occur.

The angle q between the second barb 2112 and the frame 2111 is 30-40 degrees, or 50-70 degrees. Preferably, the angle q is 50 ° to 60 °, such angle q makes it easier for the second barb 2112 to catch on the heart tissue, and the second barb 2112 does not puncture or increase the resistance to entry into the delivery device when the valve prosthesis 200 is entered into the corresponding delivery device.

The width of the second barb 2112 is s, and the width thereof is 0.2mm to 0.5 mm. Preferably 0.2mm to 0.3mm, and can maintain a good supporting force of the second barbs 2112.

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

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

Wherein, the width-thickness ratio of the second barbs 2112 and the width-thickness ratio of the first barbs 124 may be different or the same. The insufficient anchoring force of the valve stent 100 can be supplemented, for example, by adjusting the length, angle, or thickness of the second barbs 2112 to provide the second barbs 2112 with a stronger structural anchoring force.

As shown in fig. 16 and 21, the structure of the leak preventer 210 for connecting two adjacent barbs 211 can be referred to as a connecting rod 212.

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

In the present embodiment, please continue to refer to fig. 17, the height of the tie bar 212 is n. Preferably, n is 5-7mm, and the height n of the connecting rod 212 needs to be reasonably matched with the length of the anchoring part 123 of the valve stent 100, so that the length cannot be too long or too short.

Alternatively, as shown in FIG. 22, the leak protection device 210 can be connected to the valve holder 100 by a connecting rod 212 to prevent the leak protection device 210 from being displaced during use. Wherein the connecting rod 212 can be connected with the valve stent 100 by welding, sewing, bonding, etc. Preferably, the connecting rod 212 can be connected to the anchoring portion 123, so that the leak preventer 210 can be connected to the anchoring portion 123 through the connecting rod 212 to provide more radially-directed support force in cooperation with the first barb 124 on the anchoring portion 123, which facilitates better connection with the native valve in cooperation with the first barb 124, and maintains the leaflet brace 110 in the designed configuration. 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 leak prevention device 210 is located between the anchoring portion 123 and the leaflet braces 110.

Further, as shown in fig. 24, the leak prevention device 210 can also be located on the side of the anchor portion 123 away from the leaflet braces 110.

As shown in FIG. 17, the leak preventer 210 has a total height of m. Preferably, m is 10-15mm, the value of m being related to the length of the anchoring portion 123 of the valve stent 100 and the real valve anatomy. The overall height of the leak protection device 210 is less than the length of the anchoring portion 123 of the valve holder 100, taking into account the distance the corresponding valve can be anchored.

Alternatively, as shown in fig. 18, the distance between the containment device 210 and the leaflet braces 110 can be u. u may be 1mm to 8 mm. Preferably, u is 2mm to 4mm so that the leak protection device 210 can better conform to the anchoring portion 123 of the valve stent 100.

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 anchoring portion connected to the valve stent main body and provided along a circumferential direction of the leaflet stent, the anchoring portion being located outside the leaflet stent in a deployed state, and the anchoring portion and the leaflet stent having a certain interval in a radial direction of the leaflet stent;

wherein the valve stent is secured within the heart by the anchoring portion penetrating the native valve.

2. The valve stent of claim 1,

the anchoring portion has at least one first barb for piercing the native valve, the first barb extending radially outward.

3. The valve stent of claim 2, wherein the leaflet stent includes an outflow end and an inflow end, the first barbs further extending in a direction from the outflow end toward the inflow end.

4. The valve stent of claim 2, wherein the anchoring portion is provided with a barb gap adapted to the first barb, allowing the first barb to be pressed into the barb gap.

5. The valve stent according to claim 1, wherein the valve stent body is provided with a hollow-out area adapted to the anchor portion, so that the anchor portion is embedded in the hollow-out area when the valve stent is in a compressed state.

6. The valve stent of claim 2, wherein the leaflet stent includes an outflow end and an inflow end;

the anchor portion extends from the first extension portion in a direction from the inflow end toward the outflow end.

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

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

8. The valve stent of claim 2,

at least one of the first barbs extending radially outwardly at a different angle; and/or the presence of a gas in the gas,

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

9. The valve stent of claim 6, further comprising a raised portion extending from the free end of the first extension in the direction of the inflow end along the outflow end, wherein the free end of the first extension is opposite the connected end of the first extension and the leaflet stent, and wherein the raised portion is located on a side of a tangential plane to the free end of the first extension away from the inflow end.

10. The valve stent of claim 9, 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.

11. The valve stent of claim 10,

the length of the first extension part of the first skirt petal is smaller than that of the first extension part of the second skirt petal; and/or

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

12. A valve prosthesis comprising the valve stent of any one of claims 1-11.

13. The valve prosthesis of claim 12, wherein the valve prosthesis comprises a leak-proof device.

14. The valve prosthesis of claim 13, wherein the leak-proof means comprises a wavy ring.

15. The valve prosthesis of claim 13, wherein the leak-proof means comprises a connection bar between the barb and the connection barb for penetrating the native valve.