Detailed Description
The following description of the embodiments of the present application will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all embodiments of the application. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.
As shown in fig. 1, the fixing structure of the valve stent 100 of the present application is a penetrating structure to fix the valve stent 100 in the heart by penetrating the native valve through the first anchoring portion 123 of the valve stent 100 of the present application, and the first anchoring portion 123 is spaced apart from the leaflet stent 110, so that the leaflet stent 110 is not affected by the compression of diseased valve myocardial tissue and native leaflets during the use thereof, and thus the leaflet stent 110 can maintain a better design state while fixing the valve stent 100 in the heart through the first anchoring portion 123 and preventing the valve stent 100 from being displaced, thereby not affecting the movement of the leaflets on the leaflet stent 110. In addition, as the first anchoring part is used for penetrating the native valve to improve the fit degree of the valve support and myocardial tissue, the deformation amount required by the part penetrating the native valve is small, so that the part penetrating the native valve can be pressed back to a compressed state only by applying small force, so that the part penetrating the native valve on the valve support 100 in the conveying device cannot apply too much force to the conveying device, damage to the conveying device is avoided, the requirement on the release precision is not too high, the valve support 100 can be prevented from being shifted through the first anchoring part 123 in the actual operation process, and the feasibility of the actual operation is ensured.
As shown in fig. 1, the present application proposes a new valve stent 100, which comprises a valve stent body, at least one first anchoring portion 123 and at least one second anchoring portion 140, so as to fix the valve stent 100 in the heart by penetrating the primary valve through the first anchoring portion 123 and/or the second anchoring portion 140, and the second anchoring portion 140 is connected with the leaflet stent 110 in the valve stent 100 body, at least part of the second anchoring portion 140 is located at the outer side of the leaflet stent 110 in the unfolded state, so that a part of the force of the primary valve annulus is applied to the second anchoring portion 140, so that a part of the force of the primary valve annulus is applied to the other end of the leaflet stent 110, and an inward force is applied to the other end of the leaflet stent 110, so that the outward force of the first anchoring portion 123 to the other end of the leaflet stent 110 is relieved, the leaflet stent 110 is prevented from being deformed, the compression of the primary valve annulus on the first anchoring portion 123 provided at one end of the leaflet stent 110 is relieved, so that the leaflet stent 110 is relatively stable, and the leaflet located in the valve stent 100 can work stably in the actual working environment.
The valve holder body comprises a leaflet holder 110 and a skirt holder 120 connected to each other. The skirt hanger 120 and the leaflet hanger 110 can be cut from the same tube. The material of the tubing may be a memory metal so that the valve stent 100 made of the memory metal may be automatically expanded from a compressed state.
The leaflet brace 110 is generally cylindrical. The diameter of the cylinder may be between 28 and 35 mm. It is understood that the leaflets can be disposed within the leaflet brace 110.
Mounting and positioning holes may also be provided on the leaflet brace 110 to facilitate positioning and mounting of the valve.
In addition, the end of the leaflet brace 110 remote from the skirt brace extends axially to form an auxiliary element 130.
For convenience of description, both ends of the leaflet brace 110 are defined as an outflow end 112 and an inflow end 111, respectively. In the deployed state, the inflow end 111 is upstream in the blood flow direction of the outflow end 112.
Specifically, the skirt hanger 120 may extend from the inflow end 111 in a direction away from the leaflet hanger 110, and more specifically, the skirt hanger 120 may extend from an end of the leaflet hanger 110 away from the auxiliary element 130. Also, the leaflet brace 110 and skirt brace 120 may be a circular arc transition connection, or even a large circular arc transition connection.
The skirt hanger 120 may expand radially outward from the end of the leaflet hanger 110 in a radial shape.
Wherein, at least one first anchoring portion 123 is connected with the skirt bracket 120, so that the valve bracket 100 is fixed in the heart by penetrating the native valve through the first anchoring portion 123, the fitting degree of the valve bracket 100 and the heart can be improved, the axial freedom degree of the valve bracket 100 can be restrained under the tensile force of the native valve, and the probability of displacement of the valve bracket 100 after implantation is effectively reduced. In addition, in the unfolded state, the first anchoring portion 123 is located outside the leaflet support 110, and a certain distance exists 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, and the leaflet support 110 is not influenced by the compression of diseased valve myocardial tissue and native leaflets in the using process, the design state can be better maintained, and the movement of the leaflets on the leaflet support 110 is not influenced. The first anchoring portion 123 is provided with a first barb 124 for penetrating the native valve, wherein the first anchoring portion 123 may be linear, curved or otherwise shaped.
To enable the first barbs 124 to more conveniently penetrate the native valve, at least a portion of the first barbs 124 may extend radially outward of the leaflet brace 110. Preferably, the portion of the first barb 124 that penetrates the native valve is formed to extend radially outward of the leaflet brace 110.
Additionally, the first barb 124 may extend along the outflow end 112 toward the inflow end 111 to facilitate penetration of the first barb 124 into the native valve.
In this embodiment, the first barb 124 may be linear, curvilinear, or otherwise shaped.
In addition, as shown in fig. 2, the first anchoring portion 123 may be provided with a barb space 125 adapted to the first barb 124, so that the first barb 124 can be pressed into the barb space 125, and thus, when the valve stent 100 is in a compressed state, the first barb 124 is embedded in the barb space 125, and the first barb 124 is layered with the first anchoring portion 123, so that the valve stent 100 can be more easily loaded into the delivery device. Alternatively, the first barb 124 is cut from the first anchor 123.
The length h of the first barb 124 is 2mm to 12mm. The length h of the first barb 124 may refer to the length of the line between the end point of the end of the first barb 124 connected to the first anchor 123 and the end point of the end of the first barb 124 remote from the first anchor 123. Preferably, the length h of the first barb 124 is 2 mm-3 mm, so that the first barb 124 cannot easily slip off after hanging the native valve annulus or the native valve leaflet, and the phenomenon that the first barb 124 is pricked into heart tissue to cause vascular injury and puncture cannot occur.
Specifically, the angle d between the first barb 124 and the first anchoring portion 123 may be 30 ° to 40 °, or 50 ° to 70 °. Preferably, the included angle d between the first barb 124 and the first anchoring portion 123 may be 50 ° to 60 °, so that the heart tissue may be more easily caught, and the first barb 124 may not puncture the delivery device or increase the resistance of the sheath when the valve stent 100 enters the corresponding delivery device.
The thickness e of the first barb 124 may be 0.2mm to 0.5mm. Preferably, the thickness e of the first barb 124 may be 0.2mm to 0.3mm, so that a good supporting force of the first barb 124 may be maintained. In this embodiment, the first barbs 124 may be of uniform thickness (the distal end may be eliminated), and the thickness e of the first barbs 124 is the thickness excluding the distal end in the present application.
The width f of the first barb 124 may be 0.2mm to 0.6mm. Preferably, the width f of the first barb 124 is 0.2mm to 0.4mm, such that the ratio of the width f to the thickness e of the first barb is between 2/3 and 2, a more stable first barb 124 structure is easily obtained, and a better supporting force is provided.
One or more first barbs 124 may be provided on each first anchor 123. The spacing distance g between the corresponding barb voids 125 of two adjacent first barbs 124 may be 1.5-9mm. Considering the characteristics of the heart anatomy, 1.5-3mm is recommended, and the reasonable length h and spacing g of the first barbs 124 will not allow for optimal structural design due to the limited chordal tissue anchoring distance of the native valve.
The number of first barbs 124 may be 1-5. Preferably, the number of the first barbs 124 is 3, and the 3 first barbs 124 can enable the valve stent 100 to obtain reasonable length and anchoring force, and improve the bonding strength of the first barbs 124 and the native valve, so as to maintain the stability and the anti-displacement performance of the valve stent 100.
In this embodiment, to prevent the first barb 124 from abrading the surrounding tissue, the distal end of the first barb 124 is passivated or rounded.
As shown in fig. 3, the second anchoring portion 140 may be connected to the outflow end 112 of the leaflet brace 110, as long as the position where the second anchoring portion 140 is connected to the leaflet brace 110 and the position where the skirt brace 120 is connected to the leaflet brace 110 are different.
The second anchor 140 may extend from the leaflet brace 110 in the direction of the outflow end 112 toward the inflow end 111.
Further, the second anchor 140 includes a first bent portion 141 and a second bent portion 142. The first bent portion 141 may extend outward from the leaflet brace 110 in a radial direction of the leaflet brace 110. The second bending portion 142 may extend radially inward of the leaflet brace 110 from the free end of the first bending portion 141, or may be parallel to the axis of the leaflet brace 110, to avoid the second bending portion 142 penetrating the native annulus when the native annulus applies pressure to the second anchoring portion 140, resulting in the second anchoring portion 140 failing to achieve a sharing of the force applied by the native annulus.
The first bending portion 141 and the second bending portion 142 may be in arc transition connection, or even in large arc transition connection, so as to avoid the connection portion of the first bending portion 141 and the second bending portion 142 from stabbing the native valve annulus when the native valve annulus applies pressure to the second anchoring portion 140.
As shown in fig. 3 and 4, the length PL of the first bent portion 141 is 6mm to 8mm.
The acute included angle BR between the first bend 141 and the leaflet brace 110 is 40 deg. -70 deg..
The length of the second bending part 142 is 2mm-6mm.
The acute angle DB between the second bend 142 and the leaflet brace 110 is 30 ° -50 °.
The second anchoring portion 140 is spaced from the first anchoring portion 123 by a distance M of 2mm-4mm when the valve holder is in the fully deployed state.
The second anchoring portion 140 may be provided with second barbs 143 to pierce the native valve by the second barbs 143, thereby improving the fit of the valve holder 100 to the myocardial tissue by the second barbs 143 on the second anchoring portion 140 piercing the native valve. The arrangement and the size of the second barbs 143 may refer to the arrangement and the size of the first barbs 124 on the first anchoring portion 123, which will not be described herein.
In a radially disposed position of the second anchoring portion 140, as shown in fig. 4, a partial region of the second anchoring portion 140 may be located on a side of the first anchoring portion 123 remote from the leaflet holder 110. Of course, as shown in fig. 1, the second anchoring portion 140 may also be located between the leaflet brace 110 and the first anchoring portion 123 in the radial direction of the valve brace.
In the radial setting positions of the two second anchoring portions 140, the external anchoring portion is firstly applied with force during the closing process of the native valve annulus, so that the external anchoring portion can be compressed to the extent of abutting with the anchoring portion located at the inner side, the native valve annulus is supported by the outward radial supporting force generated by the anchoring portion located at the inner side, so that the native valve annulus and the leaflet support 110 maintain a certain distance in the radial direction of the valve support 100, and the anchoring force can be distributed to different parts of the leaflet support 110 while the anchoring force is supplemented by the anchoring portion located at the inner side, so that the force applied by the native valve annulus is more uniformly applied to the valve support 100, and the leaflet support 110 is more stable. Among them, the first anchoring portion 123 and the second anchoring portion 140 are referred to as anchoring portions.
Further, the force generated by the deformation of the outer-located anchoring portion may be less than the force generated by the deformation of the inner-located anchoring portion, so that the valve stent 100 of the present application may assume a "corks" configuration, allowing the outer-located anchoring portion to be relatively easily compressed to the extent of interfacing with the inner-located anchoring portion, so as to reduce the likelihood of deformation of the leaflet stent 110 when the native annulus applies force only to the outer-located anchoring portion, and after interfacing with the inner-located anchoring portion, the anchoring force may be shared by the inner-located anchoring portion while supplementing the anchoring force to a different portion of the leaflet stent 110, avoiding deformation of the leaflet stent 110, so that the valve stent 100 may better fit with native leaflet tissue.
The present application can adjust the force generated by deformation of the anchoring portion by adjusting the angle between the anchoring portion and the axis of the leaflet brace 110, the distance between the anchoring portion and the leaflet brace 110, and/or the cross-sectional area of the anchoring portion. Alternatively, the force generated by deformation of the anchoring portion may be reduced by reducing the acute included angle between the anchoring portion and the axis of the leaflet brace 110, the distance between the anchoring portion and the leaflet brace 110, and/or reducing the cross-sectional area of the anchoring portion.
Illustratively, 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.
In addition to the two radially disposed positions described above, the second anchor 140 may have another radially disposed position. Specifically, the radial distance from the axis of the end of the second anchoring portion 140 that is remote from the axis of the valve holder 100 is equal to the radial distance from the axis of the end of the first anchoring portion 123 that is remote from the axis of the valve holder 100.
In addition, in the circumferential direction, the first anchoring portions 123 and the second anchoring portions 140 may be staggered, that is, there is one second anchoring portion 140 located between two first anchoring portions 123, so as to provide more supporting points in the circumferential direction, and to make up for the shortage of the attachment wall to a great extent, and to provide better radial supporting force and anchoring force with the leaflet bracket 110, so that the valve bracket 100 better fits the round-like vessel or the native valve, so as to improve the leak-proof effect of the valve bracket 100.
Or the first anchoring portion 123 and the second anchoring portion 140 may be disposed correspondingly, i.e. the first anchoring portion 123, the second anchoring portion 140 corresponding thereto may be on the same axial cross section of the valve holder 100. Preferably, the orthographic projections of the second anchoring portion 140 and the first anchoring portion 123 on the axis of the valve support 100 at least partially overlap, such that when the original annulus compresses the outer anchoring portion into contact with the inner anchoring portion, there is a force transfer between the first anchoring portion 123 and the second anchoring portion 140 that allows the forces applied by the first anchoring portion 123 and the second anchoring portion 140 to the leaflet support 110 to be as uniform as possible to allow the leaflet support 110 to maintain its original design configuration as much as possible. Optionally, the length of the overlap of the orthographic projection of the first anchoring portion 123 on the axis of the leaflet brace 110 and the orthographic projection of the second anchoring portion 140 on the axis of the leaflet brace 110 is 2mm-6mm. In addition, referring to fig. 4, when the anchor portion located at the outer side is in contact with the anchor portion located at the inner side, the length OL by which the anchor portion located at the outer side and the anchor portion located at the inner side overlap each other is 2mm to 4mm.
Alternatively, as shown in fig. 1, the number of first anchor parts 123 and the number of second anchor parts 140 may be the same. Of course, in other implementations, for example as shown in fig. 5, the number of second anchoring portions 140 may be greater than the number of first anchoring portions 123, wherein a portion of the second anchoring portions 140 are disposed in one-to-one correspondence with the first anchoring portions 123, and another portion of each of the second anchoring portions 140 may be located between two of the first anchoring portions 123 to increase the number of support points on the circumference by increasing the number of second anchoring portions 140 to increase the leakage-preventing effect of the valve stent 100.
It is preferable that the shape of all the anchoring portions in the cross section of the valve stent 100 be matched to the shape of the native annulus to enhance the leakage prevention effect. For example, the native valve is a mitral valve, and all anchors in the cross-section of the valve holder 100 are configured in a "D" shape or a "C" shape.
There may be at least two ways of assembling the valve stent 100 of the present application.
For example, the second anchoring portion 140 and the second barbs 143 provided thereon may be assembled when they are restored to cut, i.e., the second anchoring portion 140 and the second barbs 143 provided thereon and the leaflet brace 110 are in the same plane, so that the assembly of the first anchoring portion 123 and the leaflet brace 110 will not be affected.
For another example, placing the second anchor 140 inside the first anchor 123, direct radial compression, would partially increase the difficulty of anchor assembly, but also achieve a more stable and precise release process.
Further, the skirt hanger 120 may include a first extension 121 connected with the leaflet hanger 110. The first extension 121 may extend from the leaflet brace 110 in an axial direction of the leaflet brace 110 and extend radially outward therefrom. Specifically, the first anchoring portion 123 may extend from the first extension portion 121 in the direction of the inflow end 111 toward the outflow end 112.
The first extension portion 121 and the first anchoring portion 123 may be in arc transition connection. According to the anatomical structure, it can be known that the heart tissue can generate radial pressure on the valve support 100, the stress position is the arc transition part of the first anchoring part 123 and the first extending part 121 in the skirt support 120, the corresponding deformation can occur at the moment, and the large arc transition connection is formed between the skirt support 120 and the leaflet support 110, so that the constrained deformation amount of the leaflet in the leaflet support 110 from surrounding tissue can be smaller, the function of the leaflet can not be greatly influenced, and the paravalvular leakage caused by the insufficiency of the valve is avoided.
As shown in fig. 6, the first anchoring portion 123 includes a first anchoring portion root, which is an end of the first anchoring portion 123 near the first extending portion 121, and a first anchoring portion top, which is an end of the first anchoring portion 123 far from the first extending portion 121. It will be appreciated that there may be a variety of positional relationships between the first anchoring portion 123 and the leaflet brace 110, such as, for example, the first anchoring portion 123 being parallel to the axis of the valve brace body, and such as, for example, the first anchoring portion root being closer to the axis of the valve brace body than the first anchoring portion tip, i.e., the first anchoring portion 123 extending radially outwardly of the valve brace body from the first extension 121, although not limited thereto. In addition, the angles at which the at least one first anchoring portion 123 extends radially outward may be the same, or may be different.
Among them, the one in which the root of the first anchoring portion is closer to the axis of the leaflet holder 110 is preferable because such a positional relationship allows the valve holder 100 to obtain a higher radial anchoring force.
Further, as shown in fig. 6, an included angle a exists between the first anchoring portion 123 and the first extending portion 121. Preferably, a is 120 °, although not limited thereto, and a may be other values. An angle b exists between the first extension 121 and the leaflet brace 110. The final position of the first anchoring portion 123 will be determined according to a and b in combination. As shown in fig. 3, an included angle DT exists between the first anchoring portion 123 and the leaflet brace 110. Alternatively, the included angle DT is 30 ° -60 °, and DT is not too large, and is the amount of anchoring force of the first anchoring portion to the native valve leaflet tissue, and generally, the larger the angle DT is, the larger the anchoring force generated by the first anchoring portion will be, the larger the anchoring force will generate outflow obstruction, and a certain resistance will also be generated for sheathing.
It will be appreciated that, as shown in fig. 3, when the valve stent 100 is in the deployed state, a distance ML exists between the first anchoring portion 123 and the leaflet stent 110, and a distance exists between the root of the first anchoring portion and the leaflet stent 110, i.e., the first anchoring portion 123 and the leaflet stent 110 are separated. Alternatively, the first anchoring portion 123 may be extended from a middle portion of the first extending portion 121.
In addition, the first anchor 123 does not touch the leaflet brace 110 during the cardiac cycle, so that the first anchor 123 can be prevented from interfering with the leaflet brace 110, so that the leaflet brace 110 can maintain the design form well.
In addition, the valve stent body is provided with a hollowed-out area matched with the first anchoring portion 123, so that when the valve stent 100 is in a compressed state, the first anchoring portion 123 is embedded in the hollowed-out area and is positioned on the same circumferential surface as the valve stent body, and the valve stent 100 is more easily loaded into the conveying device. As shown in fig. 1, when the valve stent 100 is in the expanded state, the first anchoring portion 123 and the leaflet stent 110 are coaxial but located on different circumferential surfaces, and the first anchoring portion 123 is spaced from the axis of the leaflet stent 110 by a distance greater than the radius of the leaflet stent 110, such that the first anchoring portion 123 contacts native valve tissue, allowing the leaflet stent 110 to maintain a relatively stable configuration. In order to obtain the valve stent 100, a tubular object made of memory metal may be cut to obtain the valve stent 100 in a compressed state, and the valve stent 100 in the compressed state may be processed to make the valve stent 100 in a deployed state, so as to obtain the valve stent 100 capable of being switched between the deployed state and the compressed state.
Further, the skirt hanger 120 may further comprise a turn 122 extending from the free end of the first extension 121 in the direction of the outflow end 112 towards the inflow end 111. Wherein the free end of the first extension 121 is opposite to the connection end of the first extension 121 and the leaflet brace 110. The tilted portion 122 is located on a side of the tangential plane to the free end of the first extension 121 away from the inflow end 111. The first extending part 121 and the raising part 122 can be in arc transitional connection, so that the connection part of the first extending part 121 and the raising part 122 can be ensured to be a smooth arc surface, and the connection part of the first extending part 121 and the raising part 122 is prevented from stabbing heart myocardial tissues. As shown in fig. 4, even the first extension portion 121 and the raised portion 122 are connected in a large arc transition.
A certain included angle can be formed between the tilting part 122 and the first extending part 121, so that the first extending part 121 is prevented from extending out to stab heart myocardial tissue, and the heart myocardium is prevented from being stimulated, and the normal function of the heart is prevented from being influenced.
In this embodiment, as shown in fig. 7, the valve stent 100 as a whole may be generally flower-shaped, and the skirt stent 120 may be seen to include a plurality of petal-like structures, which may be referred to as skirt petals, i.e., the skirt stent 120 may include a plurality of skirt petals. Specifically, the number of skirt petals in the skirt hanger 120 may be 6 to 13. Preferably, the total number of skirt petals can be 6-10, which can better fit heart myocardial tissue without increasing the resistance of the valve stent 100 to the sheath.
Wherein each skirt petal may include a first extension 121 and a kick 122 connected in sequence. Also, the first extension 121 may be the end of the skirt petals near the leaflet brace 110. Specifically, the raised portion 122 may have an arc shape, wherein the arc radius of the raised portion 122 may be 1-3mm. Preferably, the radius of the arc of the tilting portion 122 may be 1-2mm, which may better fit the anatomical structure of the heart, preventing the valve holder 100 from moving under conditions of high blood pressure.
In one embodiment, the skirt stent 120 comprises at least one first skirt petal 126 and at least one second skirt petal 127, wherein the dimension of the first skirt petal 126 in the radial direction of the leaflet stent 110 is smaller than the dimension of the second skirt petal 127 in the radial direction of the leaflet stent 110, so that the skirt stent 120 forms a similar "D" or "C" shape structure, and the outline of the native annulus attached to the native valve of the heart of a human body is similar to the "D" or "C" shape structure, thus the skirt stent 120 can better conform to the outline of the native annulus, more facilitate to conform to the real mitral anatomy, reduce the compression on the aorta, and thereby prevent perivalvular leakage.
Specifically, the first skirt petals 126 may be made smaller in the radial direction of the leaflet brace 110 than the second skirt petals 127 by making the lengths and/or angles of the first extension 121 and the lift 122 of the first skirt petals 126 different from the lengths and/or angles of the first extension 121 and lift 122 of the second skirt petals 127.
For example, as shown in fig. 8, the length of the first extension 121 of the first skirt petals 126 is less than the length of the first extension 121 of the second skirt petals 127.
For another example, the length of the turned-up portions 122 of the first skirt petals 126 is smaller than the length of the turned-up portions 122 of the second skirt petals 127.
For another example, the acute angle i of the first extension 121 of the first skirt petals 126 to the axis of the leaflet brace 110 is less than the acute angle k of the first extension 121 of the second skirt petals 127 to the axis of the leaflet brace 110.
For another example, the acute angle j of the raised portion 122 of the first skirt petal 126 to the axis of the leaflet brace 110 is less than the acute angle l of the raised portion 122 of the second skirt petal 127 to the axis of the leaflet brace 110.
In summary, the skirt stent 120 connected with the leaflet stent 110 according to the present application includes at least one first anchoring portion 123 disposed along the circumferential direction of the leaflet stent 110, and the valve stent 100 is used to be fixed in the heart by penetrating the native valve through the first anchoring portion 123, so that the degree of fitting between the valve stent 100 and the heart can be increased, the axial freedom of the valve stent 100 can be restrained under the tensile force of the native valve, the probability of displacement of the valve stent 100 after implantation can be effectively reduced, and in the deployed state, the first anchoring portion 123 is located outside the leaflet stent 110, and a certain distance exists between the first anchoring portion 123 and the leaflet stent 110 in the radial direction of the leaflet stent 110, so that the first anchoring portion 123 and the leaflet stent 110 are separated, and the leaflet stent 110 is not affected by the compression of diseased valve myocardial tissue and the native valve leaflet during the use thereof, so that the leaflet stent 110 can be better maintained in the designed state while the valve stent 100 is fixed in the heart by the first anchoring portion 123 and displacement of the valve stent 100 is prevented, and thus the movement of the leaflet stent 110 is not affected. In addition, since the first anchoring portion 123 is used to pierce the native valve to improve the adhesion between the valve stent 100 and the myocardial tissue, the portion pierced with the native valve needs a small amount of deformation, so that the portion pierced with the native valve can be pressed back into the compressed state with a small force, and thus the portion pierced with the native valve on the valve stent 100 located in the delivery device does not exert too much force on the delivery device, thereby avoiding damage to the delivery device. Moreover, the release precision is not required too high, so that the valve stent 100 can be prevented from being shifted through the first anchoring part 123 in the actual manufacturing process, and the feasibility of the actual manufacturing is ensured.
Further, the present application also proposes a valve prosthesis 200, which valve prosthesis 200 comprises the valve stent 100 of the above-described embodiment.
Optionally, the valve prosthesis 200 further comprises a leakage prevention device to improve the leakage prevention performance of the valve prosthesis 200, so that paravalvular leakage caused by the release of the valve stent 100 can be avoided. As shown in fig. 9, the leakage prevention device 210 and the valve holder 100 may be mated to form a valve prosthesis 200, which is implanted in the heart. The heart includes a left atrium LA, a left ventricle LV, and a mitral valve MV. The mitral valve includes anterior leaflet AL on anterior side a of the valve and posterior leaflet PL on posterior side P of the valve. These leaflets attach to chordae tendineae CT, which are then secured to the heart wall with papillary muscles PM. The blood vessel is then pumped out of the left ventricle into the aorta AO with the anti-reflux aorta AV.
The valve prosthesis 200 may also include leaflets. The leaflets may be located within the valve holder 100 and fixedly connected to the valve holder 100. The leaflet may be composed of a thin layer of material (typically a layer of biological film) that is movable when blood flows. The number of leaflet arrangements can be two or more. Of course, the valve prosthesis 200 may also include a one-way valve disposed within the valve holder 100, which may be used to block blood regurgitation.
The foregoing is only the embodiments of the present application, and therefore, the patent scope of the application is not limited thereto, and all equivalent structures or equivalent processes using the descriptions of the present application and the accompanying drawings, or direct or indirect application in other related technical fields, are included in the scope of the application.