Valve stents and valve prostheses

Abstract

The present application discloses a valve stent and a valve prosthesis, wherein the valve stent includes a valve stent body, including a leaflet stent and a skirt stent connected to each other; at least one first anchoring portion connected to the skirt stent and arranged along the circumference of the leaflet stent, wherein in the expanded state, the first anchoring portion is located outside the leaflet stent, and there is a certain spacing between the first anchoring portion and the leaflet stent in the radial direction of the leaflet stent; at least one second anchoring portion connected to the leaflet stent, wherein in the expanded state, at least part of the second anchoring portion is located outside the leaflet stent; wherein the valve stent is fixed in the heart by piercing the native valve through the first anchoring portion and / or the second anchoring portion. The present application fixes the valve stent in the heart and prevents the valve stent from shifting through the first anchoring portion and / or the second anchoring portion, while enabling the leaflet stent to better maintain the design state.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a valve stent and a valve prosthesis. Background Art

[0002] Heart valve disease is a very common heart disease. It not only endangers life safety and affects the quality of life, but also brings serious burden and pressure to the family and society. At present, heart valve replacement surgery can be performed, that is, a valve prosthesis is implanted into the diseased heart valve through an interventional and minimally invasive method to replace the patient's original diseased heart valve. However, due to the high blood flow pressure between the atrium and ventricle, the valve stent is prone to displacement.

[0003] Although there are some technologies that can prevent the displacement of the valve stent, the valve stents formed by these technologies always have certain defects. For example, a hook is provided on the upper end positioning component of the valve stent, and the valve stent is fixed by clamping the heart tissue between the hook and the upper end positioning component. However, the size of the hook that needs to wrap the heart tissue will be quite large, resulting in a considerable deformation of the hook during the release and compression of the valve stent. First, the hook with a large deformation will exert a large force on the conveying device loaded with the valve stent, which is easy to damage the conveying device. Secondly, when the valve stent is released, it is not necessarily possible to release the hook to a state of wrapping the heart tissue, which requires high release accuracy and is not feasible in actual operation. For another example, a barb is provided on the valve leaflet stent, and the lower edge of the human body's own valve leaflet is hooked by the barb. However, during the cardiac cycle, the valve leaflet stent in such a valve stent is easily compressed by the heart, making it impossible for the valve leaflet stent to maintain the designed shape. Summary of the invention

[0004] The present application proposes a valve stent and a valve prosthesis, which can fix the valve stent in the heart through a first anchoring portion and / or a second anchoring portion and prevent the valve stent from shifting, while allowing the leaflet stent to better maintain a designed state.

[0005] In order to solve the above technical problems, the present application proposes a valve stent, which includes a valve stent body, at least one first anchoring portion and at least one second anchoring portion;

[0006] The valve stent body comprises a leaflet stent and a skirt stent which are connected to each other;

[0007] At least one first anchoring portion is connected to the skirt support and is arranged along the circumference of the leaflet support. In the expanded state, the first anchoring portion is located outside the leaflet support, and there is a certain distance between the first anchoring portion and the leaflet support in the radial direction of the leaflet support.

[0008] At least one second anchoring portion connected to the leaflet support, wherein in the expanded state, at least a portion of the second anchoring portion is located outside the leaflet support;

[0009] The valve stent is fixed in the heart by piercing the native valve through the first anchoring part and / or the second anchoring part.

[0010] The force generated by the deformation of the anchoring portion located on the outside is smaller than the force generated by the deformation of the anchoring portion located on the inside;

[0011] The first anchoring portion and the second anchoring portion are both referred to as anchoring portions.

[0012] The cross-sectional area of ​​the anchoring portion located on the outside is smaller than the cross-sectional area of ​​the anchoring portion located on the inside.

[0013] Wherein, in the radial direction, the second anchoring portion is located between the leaflet support and the first anchoring portion.

[0014] The length of the overlap between the orthographic projection of the first anchoring portion on the axis of the leaflet stent and the orthographic projection of the second anchoring portion on the axis of the leaflet stent is 2 mm to 6 mm;

[0015] In the fully expanded state, the distance between the first anchoring portion and the second anchoring portion is 2 mm-4 mm.

[0016] Wherein, the first anchoring portion has at least one first barb for piercing the native valve, and / or the second anchoring portion has at least one second barb for piercing the native valve;

[0017] The first barb and / or the second barb extend radially outward.

[0018] The second anchoring portion extends from the outflow end of the leaflet stent along the outflow end toward the inflow end.

[0019] Wherein, the second anchoring portion comprises:

[0020] A first bent portion extends outward from the outflow end of the leaflet support along the radial direction of the leaflet support;

[0021] The second bending portion extends radially inwardly of the leaflet support or is parallel to the axis of the leaflet support.

[0022] Wherein, the skirt support comprises at least one first skirt petal and at least one second skirt petal,

[0023] The size of the first skirt petals in the radial direction of the leaflet support is smaller than the size of the second skirt petals in the radial direction of the leaflet support.

[0024] To achieve the above-mentioned object, the present application provides a valve prosthesis, which includes the above-mentioned valve stent.

[0025] The valve stent of the present application includes at least one first anchoring portion arranged along the circumference of the leaflet stent, and the valve stent is used to penetrate the native valve through the first anchoring portion and / or the second anchoring portion and be fixed in the heart, and the second anchoring portion is connected to the leaflet stent in the valve stent body. In the expanded state, at least part of the second anchoring portion is located on the outside of the leaflet stent, so that part of the force of the valve ring is applied to the second anchoring portion, so that part of the force of the valve ring is applied to one end of the leaflet stent, and an inward force is applied to one end of the leaflet stent, which will relieve the outward force brought to one end of the leaflet stent by the first anchoring portion, avoid deformation of the leaflet stent, and relieve the pressure of the valve ring on the first anchoring portion set at the other end of the leaflet stent, so that the leaflet stent is relatively stable, and can allow the leaflets located in the valve stent to work stably in the actual working environment, so that the leaflet stent can better maintain the design state. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0027] Figure 1 This is a schematic structural diagram of an embodiment of a valve stent of the present application;

[0028] Figure 2 This is a schematic diagram of the three-dimensional structure of the first anchoring portion and the first barb in the valve stent of the present application;

[0029] Figure 3 A schematic diagram of partial details of another embodiment of the valve stent of the present application;

[0030] Figure 4 A partial detail schematic diagram of another embodiment of the valve stent of the present application;

[0031] Figure 5 This is a structural schematic diagram of another embodiment of the valve stent of the present application;

[0032] Figure 6 This is a schematic diagram of the positional relationship between the first anchoring portion and the skirt bracket of the present application;

[0033] Figure 7 This is a schematic structural diagram of the valve stent of the present application from another perspective;

[0034] Figure 8 for Figure 7 The schematic diagram of position parameters of the first skirt petal and the second skirt petal shown;

[0035] Fig. 9This is a schematic diagram of the valve prosthesis of the present application being implanted into the heart. DETAILED DESCRIPTION

[0036] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0037] like Figure 1 As shown, the fixing structure in the valve stent 100 of the present application is a piercing structure, so that the valve stent 100 is fixed in the heart by piercing the native valve through the first anchoring portion 123 in the valve stent 100 of the present application, and the first anchoring portion 123 is separated from the leaflet stent 110, so that the leaflet stent 110 is not affected by the compression of the diseased valvular myocardial tissue and the native leaflet during its use. In this way, the valve stent 100 can be fixed in the heart by the first anchoring portion 123 and the valve stent 100 can be prevented from shifting, while the leaflet stent 110 can better maintain the design state, thereby not affecting the activity of the leaflets on the leaflet stent 110. In addition, because the first anchoring portion is inserted into the native valve to improve the fit between the valve stent and the myocardial tissue, the deformation amount required for the part that penetrates the native valve is small, so only a small force needs to be applied to press the part that penetrates the native valve back to a compressed state. In this way, the part of the valve stent 100 located in the delivery device that penetrates the native valve will not exert too much force on the delivery device, thereby avoiding damage to the delivery device; and in this way, there are no high requirements for the release accuracy, thereby ensuring that the first anchoring portion 123 can be used to prevent the valve stent 100 from shifting during actual operation, thereby ensuring the feasibility of actual operation.

[0038] like Figure 1As shown, the present application proposes a new valve stent 100, which includes a valve stent body, at least one first anchoring portion 123 and at least one second anchoring portion 140, so that the valve stent 100 is fixed in the heart by piercing the native valve through the first anchoring portion 123 and / or the second anchoring portion 140, and the second anchoring portion 140 is connected to the leaflet stent 110 in the valve stent body 100. In the expanded state, at least part of the second anchoring portion 140 is located outside the leaflet stent 110, so that one part of the native valve ring is fixed to the heart. Part of the force is applied to the second anchoring portion 140 to apply part of the force of the native valve ring to the other end of the leaflet stent 110. Applying an inward force to the other end of the leaflet stent 110 will alleviate the outward force brought to the other end of the leaflet stent 110 by the first anchoring portion 123, avoid deformation of the leaflet stent 110, and alleviate the pressure of the native valve ring on the first anchoring portion 123 set at one end of the leaflet stent 110, so that the leaflet stent 110 is relatively stable, and the leaflets located in the valve stent 100 can work stably in the actual working environment.

[0039] The valve stent body includes a leaflet stent 110 and a skirt stent 120 connected to each other. The skirt stent 120 and the leaflet stent 110 can be cut from the same tube. The material of the tube can be memory metal, so that the valve stent 100 made of memory metal can automatically expand from a compressed state.

[0040] The leaflet support 110 is generally cylindrical. The diameter of the cylinder may be between 28 and 35 mm. It is understood that the leaflets may be arranged in the leaflet support 110 .

[0041] The leaflet support 110 may also be provided with installation positioning holes to facilitate the positioning and installation of the valve.

[0042] In addition, one end of the leaflet support 110 away from the skirt support axially extends to form an auxiliary part 130.

[0043] For the convenience of description, the two ends of the leaflet support 110 are respectively defined as an outflow end 112 and an inflow end 111. In the expanded state, the inflow end 111 is located upstream of the outflow end 112 in the blood flow direction.

[0044] Specifically, the skirt support 120 may be extended from the inflow end 111 in a direction away from the leaflet support 110. More specifically, the skirt support 120 may be extended from the end of the leaflet support 110 away from the auxiliary member 130. Furthermore, the leaflet support 110 and the skirt support 120 may be connected by a circular arc transition, or even by a large circular arc transition.

[0045] The skirt support 120 may expand radially outward from the end of the leaflet support 110 in a radial shape.

[0046] Among them, at least one first anchoring portion 123 is connected to the skirt support 120, so that the valve support 100 is fixed in the heart by piercing the native valve through the first anchoring portion 123, which can improve the fit between the valve support 100 and the heart, and can restrain the axial freedom of the valve support 100 under the tension of the native valve, effectively reducing the probability of displacement of the valve support 100 after implantation. In addition, in the unfolded state, the first anchoring portion 123 is located outside the leaflet support 110, and there is a certain distance between the first anchoring portion 123 and the leaflet support 110 in the radial direction of the leaflet support 110, so that the first anchoring portion 123 and the leaflet support 110 are separated, so that the leaflet support 110 is not affected by the compression of the diseased valve myocardial tissue and the native leaflet during its use, and can better maintain the design state, and thus will not affect the movement of the leaflets on the leaflet support 110. The first anchoring portion 123 is provided with a first barb 124 for piercing the native valve, wherein the first anchoring portion 123 can be in a straight line, a curve or other shapes.

[0047] In order to make it easier for the first barb 124 to penetrate the native valve, at least a portion of the first barb 124 may extend radially outward of the leaflet stent 110. Preferably, the portion of the first barb 124 that penetrates the native valve is formed by extending radially outward of the leaflet stent 110.

[0048] In addition, the first barb 124 can also extend along the outflow end 112 toward the inflow end 111 to facilitate the first barb 124 to penetrate into the native valve.

[0049] In this embodiment, the first barb 124 may be in a straight line, a curve or other shapes.

[0050] In addition, if Figure 2 As shown, the first anchoring portion 123 may be provided with a barb gap 125 adapted to the first barb 124, so that the first barb 124 can be pressed into the barb gap 125, 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 and the first anchoring portion 123 are in the same layer, so that the valve stent 100 is more easily loaded into the delivery device. Optionally, the first barb 124 is cut from the first anchoring portion 123.

[0051] The length h of the first barb 124 is 2 mm to 12 mm. The length h of the first barb 124 may refer to the length of the line between the end point of the first barb 124 connected to the first anchoring portion 123 and the end point of the first barb 124 away from the first anchoring portion 123. Preferably, the length h of the first barb 124 is 2 mm to 3 mm, so that the first barb 124 will not slip off easily after hooking the native valve ring or the native valve leaflet, and the first barb 124 will not pierce into the heart tissue to cause vascular damage and puncture.

[0052] Specifically, the angle d between the first barb 124 and the first anchoring portion 123 can be 30° to 40°, or 50° to 70°. Preferably, the angle d between the first barb 124 and the first anchoring portion 123 can be 50° to 60°, which can more easily hook the heart tissue, and when the valve stent 100 enters the corresponding delivery device, the first barb 124 will not puncture the delivery device or increase the sheath resistance.

[0053] The thickness e of the first barb 124 may be 0.2 mm to 0.5 mm. Preferably, the thickness e of the first barb 124 may be 0.2 mm to 0.3 mm, which can maintain a good supporting force of the first barb 124. In this embodiment, the first barb 124 may be designed to be of equal thickness (without considering the end), and the thickness e of the first barb 124 in this application is the thickness excluding the end.

[0054] The width f of the first barb 124 can be 0.2 mm to 0.6 mm. Preferably, the width f of the first barb 124 is 0.2 mm to 0.4 mm, so that the ratio of the width f to the thickness e of the first barb is between 2 / 3 and 2, which makes it easy to obtain a more stable structure of the first barb 124 and provide better support.

[0055] One or more first barbs 124 may be provided on each first anchoring portion 123. The spacing distance g between the barb gaps 125 corresponding to two adjacent first barbs 124 may be 1.5-9 mm. Considering the characteristics of the cardiac anatomical structure, 1.5-3 mm is recommended. Due to the anchoring distance limit of the chordae tissue of the native valve, a reasonable length h and spacing distance g of the first barbs 124 can achieve the optimal structural design.

[0056] The number of the first barbs 124 may be 1 to 5. Preferably, the number of the first barbs 124 is 3, and the 3 first barbs 124 can give the valve stent 100 a more reasonable length and anchoring force, improve the bonding strength between the first barbs 124 and the native valve, and maintain the stability and anti-displacement performance of the valve stent 100.

[0057] In this embodiment, in order to prevent the first barb 124 from abrading the surrounding tissue, the end of the first barb 124 is blunted or rounded.

[0058] like Figure 3 As shown, the second anchoring portion 140 can be connected to the outflow end 112 of the leaflet stent 110, as long as the position where the second anchoring portion 140 is connected to the leaflet stent 110 is different from the position where the skirt stent 120 is connected to the leaflet stent 110.

[0059] The second anchoring portion 140 may extend from the leaflet support 110 along the outflow end 112 toward the inflow end 111 .

[0060] Further, the second anchoring portion 140 includes a first bend portion 141 and a second bend portion 142. The first bend portion 141 may extend radially outward from the leaflet support 110. The second bend portion 142 may extend radially inward from the free end of the first bend portion 141 along the leaflet support 110, or may be parallel to the axis of the leaflet support 110, so as to avoid the second bend portion 142 piercing into the native valve ring when the native valve ring applies pressure to the second anchoring portion 140, resulting in the second anchoring portion 140 being unable to share the force applied by the native valve ring.

[0061] Among them, the first bending portion 141 and the second bending portion 142 can be connected by an arc transition, or even a large arc transition, to prevent the connection between the first bending portion 141 and the second bending portion 142 from piercing the native valve ring when the native valve ring applies pressure to the second anchoring portion 140.

[0062] like Figure 3 and Figure 4 As shown, the length PL of the first bending portion 141 is 6 mm-8 mm.

[0063] The acute angle BR between the first bending portion 141 and the leaflet support 110 is 40°-70°.

[0064] The length of the second bending portion 142 is 2 mm-6 mm.

[0065] The acute angle DB between the second bending portion 142 and the leaflet support 110 is 30°-50°.

[0066] When the valve stent is in a fully expanded state, a distance M between the second anchoring portion 140 and the first anchoring portion 123 is 2 mm-4 mm.

[0067] The second anchoring portion 140 may be provided with a second barb 143, so as to penetrate the native valve through the second barb 143, thereby improving the fit between the valve stent 100 and the myocardial tissue through the second barb 143 on the second anchoring portion 140 penetrating the native valve. The arrangement and size of the second barb 143 may refer to the arrangement and size of the first barb 124 on the first anchoring portion 123, and will not be described in detail here.

[0068] At the radial setting position of the second anchoring portion 140, as Figure 4 As shown, a partial area of ​​the second anchoring portion 140 may be located on a side of the first anchoring portion 123 away from the leaflet stent 110. Figure 1As shown, in the radial direction of the valve stent, the second anchoring portion 140 is located between the leaflet stent 110 and the first anchoring portion 123 .

[0069] In the above two radially arranged positions of the second anchoring portion 140, during the closing process of the native valve ring, a force is first applied to the outer anchoring portion, so that the outer anchoring portion can be compressed to the extent of docking with the inner anchoring portion, and the native valve ring is supported by the outward radial support force generated by the inner anchoring portion, so that the native valve ring and the leaflet support 110 maintain a certain distance in the radial direction of the valve support 100, and the anchoring force is supplemented by the inner anchoring portion while the anchoring force can be distributed to different parts of the leaflet support 110, so that the force applied by the native valve ring is more evenly applied to the valve support 100, making the leaflet support 110 more stable. Among them, the first anchoring portion 123 and the second anchoring portion 140 are both called anchoring portions.

[0070] Furthermore, the force generated by the deformation of the anchoring portion located on the outside can be smaller than the force generated by the deformation of the anchoring portion located on the inside, so that the valve stent 100 of the present application presents a "cork"-like structure, allowing the anchoring portion located on the outside to be relatively easily compressed to the extent of docking with the anchoring portion located on the inside, so as to reduce the possibility of deformation of the leaflet stent 110 when the native valve ring only applies force to the anchoring portion located on the outside, and after the anchoring portion located on the outside and the anchoring portion located on the inside are docked, the anchoring force can be supplemented by the anchoring portion located on the inside and the anchoring force can be distributed to different parts of the leaflet stent 110, thereby avoiding deformation of the leaflet stent 110 and allowing the valve stent 100 to better cooperate with the native leaflet tissue.

[0071] The present application can adjust the force generated by the deformation of the anchoring portion by adjusting the angle between the anchoring portion and the axis of the leaflet support 110, the distance between the anchoring portion and the leaflet support 110, and / or the cross-sectional area of ​​the anchoring portion. Optionally, the force generated by the deformation of the anchoring portion can be reduced by reducing the acute angle between the anchoring portion and the axis of the leaflet support 110, the distance between the anchoring portion and the leaflet support 110, and / or reducing the cross-sectional area of ​​the anchoring portion.

[0072] Exemplarily, the cross-sectional area of ​​the anchor portion located on the outside is smaller than the cross-sectional area of ​​the anchor portion located on the inside.

[0073] In addition to the above two radial positions, the second anchoring portion 140 may have another radial position. Specifically, the radial distance between the end of the second anchoring portion 140 away from the axis of the valve stent 100 and the axis is equal to the radial distance between the end of the first anchoring portion 123 away from the axis of the valve stent 100 and the axis.

[0074] In addition, in the circumferential direction, the first anchoring portion 123 and the second anchoring portion 140 can be staggered, that is, there is a second anchoring portion 140 located between the two first anchoring portions 123, so as to provide more support points in the circumferential direction, which can largely make up for the lack of wall adhesion and cooperate with the leaflet stent 110 to provide better radial support force and anchoring force, so that the valve stent 100 can better fit the circular blood vessel or the native valve, so as to improve the anti-leakage effect of the valve stent 100.

[0075] Alternatively, the first anchoring portion 123 and the second anchoring portion 140 may be arranged correspondingly, that is, the first anchoring portion 123 and the corresponding second anchoring portion 140 may be on the same axial section of the valve stent 100. Preferably, the orthographic projections of the second anchoring portion 140 and the first anchoring portion 123 on the axis of the valve stent 100 at least partially overlap, so that when the original valve ring compresses the anchoring portion located on the outside to contact the anchoring portion located on the inside, there is a strong transmission between the first anchoring portion 123 and the second anchoring portion 140, so that the forces applied by the first anchoring portion 123 and the second anchoring portion 140 to the leaflet stent 110 are as consistent as possible, so that the leaflet stent 110 can maintain the original design shape as much as possible. Optionally, the length of the overlap between the orthographic projection of the first anchoring portion 123 on the axis of the leaflet stent 110 and the orthographic projection of the second anchoring portion 140 on the axis of the leaflet stent 110 is 2mm-6mm. In addition, please refer to Figure 4 When the anchoring portion located on the outside contacts the anchoring portion located on the inside, the overlapping length OL of the anchoring portion located on the outside and the anchoring portion located on the inside is 2mm-4mm.

[0076] Alternatively, if Figure 1 As shown, the number of the first anchoring portions 123 and the number of the second anchoring portions 140 may be the same. Of course, in other implementations, for example, Figure 5 As shown, the number of the second anchoring portions 140 can be greater than the number of the first anchoring portions 123, wherein a portion of the second anchoring portions 140 are arranged one-to-one with the first anchoring portions 123, and each of the other portion of the second anchoring portions 140 can be located between two first anchoring portions 123, so as to increase the number of supporting points on the circumference by increasing the number of the second anchoring portions 140, so as to improve the anti-leakage effect of the valve stent 100.

[0077] Preferably, the shape formed by all anchoring parts on the cross section of the valve stent 100 matches the shape of the native valve ring to improve the anti-leakage effect. For example, if the native valve is a mitral valve, the shape formed by all anchoring parts on the cross section of the valve stent 100 is a "D" shape or a "C" shape.

[0078] The valve stent 100 of the present application can be assembled in at least two ways.

[0079] For example, the second anchoring portion 140 and the second barb 143 provided thereon can be restored to the state at the time of cutting for assembly, that is, the second anchoring portion 140 and the second barb 143 provided thereon and the leaflet stent 110 are in the same plane, which will not affect the assembly of the first anchoring portion 123 and the leaflet stent 110.

[0080] For another example, the second anchoring portion 140 is placed inside the first anchoring portion 123 and directly radially compressed. Such an assembly process will partially increase the difficulty of assembling the anchoring portion, but a more stable and precise release process is also achieved.

[0081] Further, the skirt support 120 may include a first extension portion 121 connected to the leaflet support 110. The first extension portion 121 may be formed by extending from the leaflet support 110 along the axial direction of the leaflet support 110 and extending radially outward. Specifically, the first anchor portion 123 may extend from the first extension portion 121 along the inflow end 111 toward the outflow end 112.

[0082] The first extension portion 121 and the first anchoring portion 123 may be connected in an arc transition. According to the anatomical structure, the heart tissue will generate radial pressure on the valve stent 100, and the force-bearing position is the arc transition portion between the first anchoring portion 123 and the first extension portion 121 in the skirt stent 120; at this time, the portion will be deformed accordingly, and because the skirt stent 120 and the leaflet stent 110 are connected in a large arc transition, the leaflets in the leaflet stent 110 are constrained by the surrounding tissues and the deformation amount will be small, which will not have a significant impact on the function of the leaflets, thereby avoiding paravalvular leakage caused by valve insufficiency.

[0083] like Figure 6 As shown, the first anchoring portion 123 includes a first anchoring portion root and a first anchoring portion top, wherein the first anchoring portion root is the end of the first anchoring portion 123 close to the first extension portion 121, and the first anchoring portion top is the end of the first anchoring portion 123 away from the first extension portion 121. It can be understood that there can be a variety of positional relationships between the first anchoring portion 123 and the leaflet stent 110, for example, the first anchoring portion 123 is parallel to the axis of the valve stent body; for example, relative to the first anchoring portion top, the first anchoring portion root is closer to the axis of the valve stent body, that is, the first anchoring portion 123 extends radially outward from the first extension portion 121 along the valve stent body, of course, not limited to this. In addition, the radially outward extension angle of at least one first anchoring portion 123 can be the same, of course, it can also be different.

[0084] Among them, the solution in which the root of the first anchoring portion is closer to the axis of the leaflet stent 110 is more preferred, because such a positional relationship will allow the valve stent 100 to obtain a higher radial anchoring force.

[0085] Furthermore, if Figure 6 As shown, there is an angle a between the first anchoring portion 123 and the first extension portion 121. Preferably, a is 120°, but it is not limited thereto, and a can be other values. There is an angle b between the first extension portion 121 and the leaflet support 110. The final position of the first anchoring portion 123 will be determined based on a and b. Figure 3 As shown, there is an angle DT between the first anchoring portion 123 and the leaflet support 110. Optionally, the angle DT is 30°-60°, and DT cannot be too large. The angle DT determines the magnitude of the anchoring force of the first anchoring portion on the native leaflet tissue. Generally speaking, the larger the angle DT, the greater the anchoring force generated by the first anchoring portion. Excessive anchoring force will cause outflow tract obstruction and will also produce certain resistance to sheath installation.

[0086] It is understandable that if Figure 3 As shown, when the valve stent 100 is in the expanded state, there is a certain distance ML between the first anchoring portion 123 and the leaflet stent 110, and there is a distance between the root of the first anchoring portion and the leaflet stent 110, that is, the first anchoring portion 123 is separated from the leaflet stent 110. Optionally, the first anchoring portion 123 may be extended from the middle portion of the first extension portion 121.

[0087] In addition, during the cardiac cycle, the first anchoring portion 123 does not touch the leaflet stent 110, which can prevent the first anchoring portion 123 from interfering with the leaflet stent 110, so that the leaflet stent 110 can maintain the designed shape well.

[0088] In addition, a hollow area adapted to the first anchoring portion 123 is provided on the valve stent body, so that when the valve stent 100 is in a compressed state, the first anchoring portion 123 is embedded in the hollow area and located on the same circumferential surface as the valve stent body, making it easier to load the valve stent 100 into the delivery device. Figure 1 As shown, when the valve stent 100 is in the expanded state, the first anchoring portion 123 and the leaflet stent 110 are coaxial but located on different circumferential surfaces, and the distance between the first anchoring portion 123 and the axis of the leaflet stent 110 is larger than the radius of the leaflet stent 110, so that the first anchoring portion 123 is in contact with the native valve tissue, allowing the leaflet stent 110 to maintain a relatively stable structure. To facilitate obtaining the above-mentioned valve stent 100, a compressed valve stent 100 can be obtained by cutting a tubular object made of a memory metal material, and the compressed valve stent 100 is processed to make the valve stent 100 reach the expanded state, so as to obtain a valve stent 100 that can be switched between the expanded state and the compressed state.

[0089] Furthermore, the skirt support 120 may also include a raised portion 122 extending from the free end of the first extension portion 121 along the outflow end 112 toward the inflow end 111. The free end of the first extension portion 121 is opposite to the connection end of the first extension portion 121 and the leaflet support 110. The raised portion 122 is located on the side of the tangent plane of the free end of the first extension portion 121 away from the inflow end 111. The first extension portion 121 and the raised portion 122 may be connected in a circular arc transition, which can ensure that the connection between the first extension portion 121 and the raised portion 122 is a smooth arc surface, thereby preventing the connection between the first extension portion 121 and the raised portion 122 from piercing the myocardial tissue of the heart. Figure 4 As shown, even the first extension portion 121 and the tilted portion 122 are connected by a large arc transition.

[0090] A certain angle may be formed between the tilted portion 122 and the first extension portion 121 to prevent the first extension portion 121 from extending straight out and piercing the cardiac myocardial tissue, thereby preventing the cardiac myocardium from being stimulated and affecting the normal function of the heart.

[0091] In this embodiment, if Figure 7 As shown, the valve stent 100 as a whole can be roughly flower-shaped, and the skirt stent 120 can be regarded as including a plurality of petal-shaped structures, which can be called skirt petals, that is, the skirt stent 120 can include a plurality of skirt petals. Specifically, the number of skirt petals in the skirt stent 120 can be 6 to 13. Preferably, the total number of skirt petals can be 6 to 10, which can better fit the heart muscle tissue without increasing the resistance of the valve stent 100 entering the sheath.

[0092] Each skirt petal may include a first extension portion 121 and a tilting portion 122 connected in sequence. In addition, the first extension portion 121 may be the end of the skirt petal close to the leaflet support 110. Specifically, the tilting portion 122 may be in an arc shape, wherein the arc radius of the tilting portion 122 may be 1-3 mm. Preferably, the arc radius of the tilting portion 122 may be 1-2 mm, which may better fit the anatomical tissue structure of the heart and prevent the valve support 100 from moving under high blood pressure.

[0093] In one embodiment, the skirt support 120 includes 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 support 110 is smaller than the dimension of the second skirt petal 127 in the radial direction of the leaflet support 110, so that the skirt support 120 forms a "D" or "C" shaped structure. According to the contour of the native valve ring attached to the native valve of the human heart, it is similar to the "D" or "C" shaped structure. In this way, the skirt support 120 can better fit the shape of the native valve ring, which is more conducive to matching the real mitral valve anatomical structure, reducing the pressure on the aorta, and thus preventing paravalvular leakage.

[0094] Specifically, the length and / or angle of the first extension portion 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 portion 121 and the raised portion 122 of the second skirt petal 127; the size of the first skirt petal 126 in the radial direction of the leaflet support 110 can be smaller than the size of the second skirt petal 127 in the radial direction of the leaflet support 110.

[0095] For example, Figure 8 As shown, the length of the first extension portion 121 of the first skirt petal 126 is smaller than the length of the first extension portion 121 of the second skirt petal 127 .

[0096] For another example, the length of the raised portion 122 of the first skirt petal 126 is smaller than the length of the raised portion 122 of the second skirt petal 127 .

[0097] For another example, the acute angle i between the first extension portion 121 of the first skirt petal 126 and the axis of the leaflet support 110 is smaller than the acute angle k between the first extension portion 121 of the second skirt petal 127 and the axis of the leaflet support 110 .

[0098] For another example, the acute angle j between the raised portion 122 of the first skirt petal 126 and the axis of the leaflet support 110 is smaller than the acute angle l between the raised portion 122 of the second skirt petal 127 and the axis of the leaflet support 110 .

[0099] In summary, the skirt stent 120 connected to the leaflet stent 110 of the present application includes at least one first anchoring portion 123 arranged along the circumference of the leaflet stent 110. The valve stent 100 is used to penetrate the native valve through the first anchoring portion 123 and be fixed in the heart, which can improve the fit between the valve stent 100 and the heart, and can restrain the axial freedom of the valve stent 100 under the tension of the native valve, effectively reducing the probability of displacement of the valve stent 100 after implantation; and in the expanded state, the first anchoring portion 123 is located outside the leaflet stent 110. side, and there is a certain distance between the first anchoring portion 123 and the leaflet support 110 in the radial direction of the leaflet support 110, so that the first anchoring portion 123 and the leaflet support 110 are separated, so that the leaflet support 110 is not affected by the compression of the diseased valve myocardial tissue and the native leaflet during its use. In this way, the valve support 100 can be fixed in the heart by the first anchoring portion 123 and the valve support 100 can be prevented from shifting, while the leaflet support 110 can better maintain the design state, and thus will not affect the movement of the leaflets on the leaflet support 110. In addition, because the first anchoring portion 123 penetrates the native valve to improve the fit between the valve support 100 and the myocardial tissue, the deformation amount required for the part that penetrates the native valve is small, so only a small force is needed to press the part that penetrates the native valve back to the compressed state, so that the part of the valve support 100 that penetrates the native valve in the delivery device will not exert too much force on the delivery device, thereby avoiding damage to the delivery device. Moreover, there is no high requirement for the release accuracy, which ensures that the first anchoring portion 123 can prevent the valve stent 100 from shifting during the actual manufacturing process, thereby ensuring the feasibility of the actual manufacturing.

[0100] Furthermore, the present application also proposes a valve prosthesis 200 , which includes the valve stent 100 of the above embodiment.

[0101] Optionally, the valve prosthesis 200 further includes a leak-proof device to improve the leak-proof performance of the valve prosthesis 200, thereby preventing the occurrence of paravalvular leakage caused by the release of the valve stent 100. Fig. 9 As shown, the anti-leak device 210 and the valve support 100 can be combined to form a valve prosthesis 200 and implanted in the heart. The heart includes a left atrium LA, a left ventricle LV and a mitral valve MV. The mitral valve includes an anterior leaflet AL located on the front side A of the valve and a posterior leaflet PL located on the posterior side P of the valve. These leaflets are attached to the chordae tendineae CT, which are then fixed to the heart wall with papillary muscles PM. The blood vessel is then pumped out of the left ventricle into the aorta AO with the aorta AV preventing backflow.

[0102] The valve prosthesis 200 may further include leaflets. The leaflets may be located in the valve support 100 and fixedly connected to the valve support 100. The leaflets may be composed of a thin layer of material (usually a layer of biofilm) and may be movable when blood flows. The number of leaflets may be two or more. Of course, the valve prosthesis 200 may further include a one-way valve disposed in the valve support 100, which may be used to block blood backflow.

[0103] The above are only implementation methods of the present application, and are not intended to limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made using the contents of the present application specification and drawings, or directly or indirectly applied in other related technical fields, are also included in the patent protection scope of the present application.

Claims

1. A valve stent, characterized in that: The valve support comprises: The valve support body comprises a leaflet support and a skirt support which are connected to each other; At least one first anchoring portion, connected to the skirt support, and arranged along the circumference of the leaflet support, wherein in the expanded state, the first anchoring portion is located outside the leaflet support, and there is a certain distance between the first anchoring portion and the leaflet support in the radial direction of the leaflet support; At least one second anchoring portion is connected to the leaflet support, and in the expanded state, at least part of the second anchoring portion is located outside the leaflet support; in the radial direction, the second anchoring portion is located between the leaflet support and the first anchoring portion, and the length of the orthographic projection of the first anchoring portion on the axis of the leaflet support and the orthographic projection of the second anchoring portion on the axis of the leaflet support coincides with each other by 2mm-6mm; in the fully expanded state, the spacing between the first anchoring portion and the second anchoring portion is 2mm-4mm; Wherein, the valve stent is fixed in the heart by piercing the native valve through the first anchoring portion and / or the second anchoring portion; The first anchoring portion has at least one first barb for piercing the native valve, and / or the second anchoring portion has at least one second barb for piercing the native valve; Wherein, the first barb and / or the second barb extend radially outward.

2. The valve stent according to claim 1, characterized in that: The force generated by the deformation of the anchoring portion located on the outside is smaller than the force generated by the deformation of the anchoring portion located on the inside; The first anchoring portion and the second anchoring portion are both referred to as the anchoring portion.

3. The valve stent according to claim 2, characterized in that: The cross-sectional area of ​​the anchor portion located on the outside is smaller than the cross-sectional area of ​​the anchor portion located on the inside.

4. The valve stent according to claim 1, characterized in that: The second anchoring portion extends from the outflow end of the leaflet stent along the outflow end toward the inflow end.

5. The valve stent according to claim 4, characterized in that: The second anchoring portion comprises: A first bending portion extending outward from the outflow end of the leaflet support along the radial direction of the leaflet support; The second bending portion extends radially inwardly of the leaflet support or is parallel to the axis of the leaflet support.

6. The valve stent according to claim 1, characterized in that: The skirt support comprises at least one first skirt petal and at least one second skirt petal, The size of the first skirt petals in the radial direction of the leaflet support is smaller than the size of the second skirt petals in the radial direction of the leaflet support.

7. A valve prosthesis, characterized in that: Comprising the valve stent according to any one of claims 1-6.

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