CN112674909A - Artificial valve prosthesis - Google Patents

Abstract

The invention discloses an artificial valve prosthesis, comprising a bracket body and a valve leaflet assembly, the bracket body includes a first bracket and a second bracket, the first bracket has a connecting end, wherein the second bracket includes a plurality of bracket rods, a plurality of The support rods are respectively fixed to the connecting ends of the first support, the leaflet assembly has a first leaflet fixing part, and the leaflet assembly is fixed to the connecting end of the first support through the first leaflet fixing part. Compared with the frame structure composed of several closed geometric units in the prior art, the second stent of the present invention is mainly composed of several stent rods, which reduces the material of the stent body of the present invention, thereby reducing the cross-sectional area of the delivery device, thereby reducing the The wound area of the patient is reduced; in addition, the stent structure in the region sandwiched by the valve leaflet assembly and the second stent is relatively sparse, and blood is not easily deposited there, thus reducing the risk of thrombosis.

Description

Artificial valve prosthesis

Technical Field

The invention relates to the field of medical instruments, in particular to a transcatheter prosthetic heart valve prosthesis.

Background

The heart contains four chambers, the Right Atrium (RA), the Right Ventricle (RV), the Left Atrium (LA), and the Left Ventricle (LV). The pumping action on the left and right sides of the heart generally occurs simultaneously throughout the cardiac cycle. The valve that separates the atrium from the ventricle is called the atrioventricular valve, which acts as a one-way valve to ensure the normal flow of blood in the heart chamber. The atrioventricular valve between the left atrium and the left ventricle is the mitral valve, and the atrioventricular valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary arteries and from there to the lungs; the blood returns to the left atrium through the pulmonary veins. The aortic valve directs blood flow through the aorta and from there to the periphery. There is usually no direct connection between the ventricles or between the atria.

At the beginning of ventricular filling (diastole), the aortic and pulmonary valves close to prevent regurgitation from the arteries into the ventricles. Shortly thereafter, the atrioventricular valves open to allow unimpeded flow from the atria into the respective ventricles. Shortly after the start of ventricular systole (i.e., ventricular emptying), the tricuspid and mitral valves normally close, thereby forming a seal that prevents backflow from the ventricles into the respective atria.

When problems occur with the atrioventricular valve, it fails to function properly, resulting in improper closure. Atrioventricular valves are complex structures that typically include an annulus, leaflets, chordae tendineae, and a support structure. Each atrium is connected to its valve by an atrial atrium. The mitral valve has two leaflets, a similar structure of the tricuspid valve has three leaflets, and attachment or engagement of the respective surfaces of each leaflet to one another helps provide closure or sealing of the valve, thereby preventing blood flow in the wrong direction. Failure of the leaflets to seal during ventricular systole is known as poor coaptation and can allow blood to flow in the reverse direction through the valve (regurgitation). Cardiac valve insufficiency can have serious consequences for a patient, often leading to heart failure, reduced blood flow, reduced blood pressure, and/or reduced oxygen flow to human tissue. Mitral insufficiency may also cause blood to flow from the left atrium back into the pulmonary veins, causing congestion. Severe valvular insufficiency, if left untreated, can lead to permanent disability or death.

Left ventricular outflow obstruction is mainly caused by the fact that in patients with hypertrophic cardiomyopathy, the ventricular septum is thickened and is asymmetrically thickened, so that the outflow path of the left ventricle when blood is ejected outwards becomes narrow. When the heart contracts, blood passes through a narrow place, because the force at the narrow place is very large, and the native valve leaflets are replaced or repaired to two sides, the force can attract the native mitral valve to the ventricular septum, so that the stenosis is more serious, and the native valve leaflets can completely block the blood outflow path at the later stage of the heart contraction, so that a left ventricular outflow tract obstruction is formed. The common symptoms of left ventricular outflow tract obstruction are palpitation, shortness of breath, hypodynamia, angina pectoris, syncope, angina pectoris attack and heart failure in late stage.

Thrombi are small patches of blood flow that form on the surface of a denuded or repaired site within a blood vessel of the cardiovascular system. In the variable fluid-dependent type, thrombi are composed of insoluble fibrin, deposited platelets, accumulated white blood cells and entrapped red blood cells. When the intima is damaged, endothelial cells are denatured, necrotic and shed, and collagen fibers under the endothelium are exposed, so that factor XII of an endogenous blood coagulation system is activated, the endogenous blood coagulation system is activated, and the damaged intima can release tissue blood coagulation factors and activate an exogenous blood coagulation system. The damaged intima becomes rough, making the platelets easily aggregate, mainly adhering to the bare collagen fibers.

In recent years, there have been some breakthrough advances in the field of prosthetic valves, but due to the complexity of the mitral valve and its surrounding structures, mitral valve treatment still faces significant challenges, e.g., 1, how to address the deposition of blood flow at the leaflet-stent junction, avoiding thrombosis there; 2. how to reduce the diameter of the delivery valve device, thereby reducing the wound area upon implantation; 3. how to avoid native valve leaf to block up the outflow tract, solve the outflow tract and block up the problem.

Disclosure of Invention

The invention provides a prosthetic valve prosthesis which can solve the defects in the prior art.

The technical scheme of the invention is as follows:

a prosthetic valve prosthesis comprises a stent main body and a valve leaflet component,

the support main part is including constructing first support and the second support that has latticed frame construction, first support has the link, wherein, the second support includes a plurality of cradling pieces, and is a plurality of the cradling piece is fixed in respectively the link of first support, the leaflet subassembly disposes first leaflet fixed part, first leaflet fixed part is fixed in the link of first support.

Compared with the prior art that the main body of the bracket is of a frame structure consisting of a plurality of closed geometric units, the first bracket of the invention is of a latticed frame structure so as to ensure that the main body of the bracket can be compressed into the conveying device, and the second bracket mainly consists of a plurality of bracket rods, so that the material of the main body of the bracket of the invention is reduced, the section area of the conveying device is reduced, and the wound area of a patient is reduced; and the valve leaflet component and the area clamped by the second support and the side far away from the first support have relatively sparse support structures, and blood is not easy to deposit at the positions, so the risk of thrombosis is reduced. In addition, the sparse stent structure also facilitates reducing the risk of outflow obstruction or obstruction when the second stent is anchored within the ventricle.

In some embodiments, the first leaflet securing portion is configured to have an extension arc matching the connecting end such that there is a coincidence between the first leaflet securing portion and the connecting end. At this time, the region between the leaflet assembly and the stent main body and the side far away from the first stent are completely sparse structures formed by the stent rods, and blood can be prevented from depositing in the region.

In some embodiments, the stent rod is fixed to an end (one end or both ends) of the connecting end, or the stent rod is disposed in such a manner as to be disposed between the adjacent two leaflets. Preferably, when the leaflet assembly is configured with a plurality of leaflets, a junction between two adjacent leaflets is configured as a second leaflet securing portion, and the leaflet assembly is further secured to the support rod by the second leaflet securing portion. By the structure, the support rod can provide a fixed position for the valve leaflets, provide corresponding acting force for the opening and closing of the valve leaflets, the adjacent valve leaflets are fixed to the support rod through the second valve leaflet fixing parts at the joint, the opening amplitude of the valve leaflets is reduced, the acting force for beating tissues when the valve leaflets open is reduced, and the service life of the valve leaflets is prolonged.

Further, the number of the rack bar is at least 2, preferably 2 to 5. The support rods are too many in number, the material of the support main body can be increased, the section area of the conveying device is increased, the wound area can be increased, the number of the support rods is too small, and sufficient fixing force cannot be provided for the valve leaflets to ensure the valve leaflets to be opened and closed smoothly.

In some embodiments, the stent rod is configured to have a first end fixed with the first stent, the stent rod further having a leaflet attachment for fixing a leaflet, the distance between the leaflet attachment to an end surface of the first end being 1/12-1/2 of the length of the stent rod. Because of first support area is great, the valve leaf is sewed up on the second cradling piece that is close to first support, does benefit to first support and shares the effort of valve leaf to the cradling piece, increases the durability of cradling piece.

Preferably, the first end portion is configured to be a column or a horn, and when the first end portion is configured to be the horn, the support rod and the first support can be made smooth and excessive, so that the force applied to the support rod can be uniformly distributed on the whole first support, and the durability of the support main body is improved. Further, the leaflet attachment portion is configured as a number of suture holes, preferably circular holes, the number of suture holes being 1-10, preferably 2-5.

In some embodiments, the free end of at least one of the stent rods is configured as a hook for hooking the native valve leaflet, which fixes the native valve leaflet to prevent the native valve leaflet from blocking the outflow tract, and can also be used for hooking tissue to play a certain anchoring role. Preferably, at least two of the stent rods of the second stent are provided with the hook parts, wherein the hook parts are symmetrically arranged, so that native valve leaflets can be effectively fixed, and the anchoring of the stent main body is more stable.

In some embodiments, the angle γ of the second support to the first support is 10-175 °, preferably γ is 90-160 °. At this angle, the first stent may be tightly engaged with the atrium, which may provide the stent with sufficient anchoring sites.

In some embodiments, the second stent further comprises a leaflet cutter for cutting the native leaflets, which cut the native mitral valve open and are hooked by the stent rods on both sides, preventing the native leaflets from blocking the outflow tract.

Preferably, the leaflet cutting member is fixed to the connecting end of the first stent and positioned between two adjacent stent rods, so that the native leaflet can be fixed by the hook parts of the stent rods on both sides after being cut.

In some embodiments, the leaflet cutting element is configured to extend away from the leaflet assembly and the angle α between the leaflet cutting element and the direction in which the stent rod extends is 0-90 °, and more preferably 0-45 °. This design can guarantee before the cradling piece hooks native leaflet, and the leaflet cutting piece has already cut native leaflet, can avoid too big native leaflet to plug up the outflow tract, and this angle can guarantee simultaneously that the leaflet cutting piece does not disturb the normal switching of replacement leaflet.

In some embodiments, the leaflet cutting element is configured with cuts that are triangular, square, or have rounded cutting edges.

The cutting portions are disposed from a free end of the leaflet cutting member toward the other end thereof, and preferably, a plurality of the cutting portions are disposed in a continuous manner or a plurality of the cutting portions are disposed in a discontinuous manner in a direction in which the leaflet cutting member extends.

In some embodiments, the prosthetic valve prosthesis is used to replace a diseased native leaflet, such as replacing the anterior or posterior leaflet of a mitral valve, or the repair of a tricuspid, aortic valve, and the stent body is configured in a non-occluding configuration and, when the valve prosthesis is used to replace a native valve, the stent body is configured in an annular configuration that is circumferentially occluded.

Compared with the prior art, the invention has the following beneficial effects:

compared with the prior art that the main body of the stent is a frame structure consisting of a plurality of closed geometric units, the arrangement of the stent rods reduces the material of the main body of the stent, thereby reducing the section area of a conveying device and further reducing the wound area of a patient; in addition, the side of the valve leaflet component, which is far away from the first support, in the area clamped by the second support is not easy to deposit blood, so that the risk of forming thrombus is reduced; in addition, the configuration of the stent rod helps to reduce outflow obstruction or obstruction when the second stent is anchored within the ventricle.

Secondly, in the prosthetic valve prosthesis of the present invention, the connecting end of the first stent is configured to have a radian matching with the leaflet fixing end, after the leaflet assembly is fixed, the first leaflet fixing portion completely coincides with the connecting end of the first stent, and on the side away from the first stent, the area sandwiched between the leaflet assembly and the second stent is completely a relatively sparse structure composed of stent rods, such that blood is not deposited there, and the risk of thrombosis is further reduced; meanwhile, the material of the bracket main body is further reduced, and the section area of the conveying device is reduced.

Thirdly, the free end of the support rod of the artificial valve prosthesis is also provided with a hook part for hooking the native valve leaflet to form a retention force to the native valve leaflet, so that the native valve leaflet is prevented from blocking the outflow channel in the heart contraction process, and the free end of the support rod can also be used for hooking tissues to play a certain anchoring role; the second stent is also configured with a leaflet cutter, which can cut the native leaflets and be hooked by the stent rods on both sides, preventing the larger native leaflets from blocking the outflow tract.

Of course, it is not necessary for any product that implements the invention to achieve all of the above-described advantages at the same time.

Drawings

Fig. 1 is a schematic overall structure view of a valve prosthesis according to example 1 of the present invention, in which fig. 1A is a schematic structural view of a stent main body, and fig. 1B is a schematic structural view of a leaflet assembly;

FIG. 2 is a schematic view showing the overall structure of a stent body in the prior art;

FIG. 3 is a schematic view showing the overall structure of a support rod according to embodiment 1 of the present invention;

FIG. 4 is a partial structural view of a stent body according to example 1 of the present invention;

FIG. 5 is a partial structural view of another stent body according to embodiment 1 of the present invention;

fig. 6(A, B, C, D) is a schematic structural view of leaflet cutting members according to example 1 of the present invention.

Reference numerals: a first bracket 110; a leaflet assembly 130; a second bracket 120; a bracket bar 121; a first leaflet fixing part 134, a second leaflet fixing part 135; leaflets (131, 132, 133); a connection end 210; a first connection end 211; a second connection end 212; a third connection terminal 213; a first end portion 120-1; a leaflet attachment portion 120-2; a hook portion 120-3; a leaflet cutter 140; a cutting part 141.

Detailed Description

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be specifically understood by those of ordinary skill in the art.

As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

The invention will be further illustrated with reference to the following specific examples.

Example 1

This embodiment provides a prosthetic valve prosthesis (also referred to as a valve prosthesis) comprising a stent body and a leaflet assembly 130, see fig. 1A-6D. Wherein, the stent main body can be used as a support structure of the leaflet assembly 130, and at the same time, can perform an anchoring function for anchoring with tissue, a function for connecting with a delivery device (for example, a hanger or a fixing ear is arranged at one end or two ends of the stent main body), and the like. The prosthetic valve prosthesis of this embodiment is a transcatheter delivered valve prosthesis, which is compressed into a delivery device for delivery when implanted, and released and anchored after delivery to a target location. The stent main body is made of biocompatible materials such as nickel titanium or cobalt chromium, the leaflet assembly 130 comprises at least one artificial leaflet, and a corresponding number of artificial leaflets can be arranged according to actual clinical requirements, wherein the artificial leaflets can be biological tissues such as bovine pericardium, porcine pericardium and equine pericardium.

Referring to fig. 1A, the stent body includes a first stent 110 and a second stent 120 configured to have a lattice-shaped frame structure, the first stent 110 having a connection end 210, the first stent 110 being connected to the second stent 120 through the connection end 210. The second stent 120 includes a plurality of stent rods 121, the stent rods 121 are respectively fixed to the connecting ends 210 of the first stent 110, the leaflet assembly 130 is configured with a first leaflet fixing portion 134, and the first leaflet fixing portion 134 is fixed to the connecting end 210 of the first stent 110.

Wherein first stent 110 is configured as a lattice-like framework structure composed of an arrangement of closed geometric cells including, but not limited to, triangular, square, pentagonal, drop-shaped, heart-shaped, diamond-shaped, etc., preferably composed of an arrangement of diamond-shaped cells, such that first stent 110 may be compressed into a delivery catheter for delivery, and upon release thereof, first stent 110 self-expands to its original shape. The stent rods 121 may be fixed at the apexes of the diamond-shaped cells or at the sides of the diamond-shaped cells of the first stent 110 so that the entire stent body may be compressed while being self-expandable.

In the prior art, the entire stent main body is a frame structure formed by arranging a plurality of closed geometric units, and fig. 2 is a schematic view of a partial structure of the stent main body in the prior art, and the stent main body comprises an upper flaring, an upper part of a lower ventricle, a middle part of the lower ventricle and a lower part of the lower ventricle, wherein the upper flaring is anchored in an atrium, valve leaflets are fixed in the middle part of the lower ventricle of the stent main body, the lower part of the lower ventricle is located in the ventricle, and blood flows in from the upper flaring and flows out from the lower part of the lower ventricle. After the valve leaflets are fixed, a region is clamped at the connecting part of the frame structure and the valve leaflets and on the side close to the lower part of the lower ventricle, and the region is easy to deposit blood to form thrombus.

To address the problem of thrombosis, the prior art typically applies an anti-thrombotic treatment to the material in contact with the blood to reduce the formation of thrombus, but there is still a risk of thrombus formation. Meanwhile, how to reduce the material of the valve prosthesis so as to reduce the diameter of the delivery device is also a great problem.

Unlike the structure of the stent body and the technical concept of solving thrombosis in the prior art, the stent body of the present embodiment includes a first stent 110 and a second stent 120, wherein the second stent 120 includes a plurality of stent rods 121 fixed to the connection ends 210 of the first stent, and the rod-like structure of the stent rods 121 allows the second stent 120 to be formed into a relatively sparse stent structure. Unlike the prior art frame structure in which the middle and lower portions of the lower ventricle are both in a grid shape, the second stent 120 of the present embodiment does not form a staggered network in a direction perpendicular to the direction in which the stent struts extend. The relatively sparse structure of the second stent 120, where the leaflet assembly 130 is attached to the stent body and distal from the first stent 110, makes blood less likely to be deposited in this area, reducing the risk of thrombus formation in this area. At the same time, the structure of the second stent 120 also reduces the material of the stent body, thereby reducing the cross-sectional area over which the valvular prosthesis is delivered, and thus reducing the trauma area of the patient.

Further, when the first stent 110 is anchored mainly in the atrium and the second stent 120 is anchored in the ventricle, the second stent 120 is structured such that the valvular prosthesis is more sparsely arranged on the side close to the outflow tract than the stent body of the related art, so that when the valvular prosthesis of the present embodiment is used as a mitral valve, the obstruction of the left ventricular outflow tract can be reduced, and when it is used as an aortic valve, the obstruction of the left ventricular outflow tract can be reduced.

Since the first leaflet securing section 134, to which the leaflet assembly 130 is fixed, has a certain arc, in some embodiments, the connecting end 210 is configured to have an extended arc matched with the first leaflet securing section 134 so that the first leaflet securing section 134 and the connecting end 210 are completely overlapped. Such a configuration, where the leaflet assembly 130 is connected to the main stent body and away from the first stent 110, is a sparse structure formed by a plurality of stent rods, further reducing the risk of thrombosis in this area.

In this embodiment, the number of the rack bars 121 is at least 2, preferably 2 to 5. The quantity of the support rods is too much, the material of the support main body can be increased, and the section area of the conveying device is increased, so that the wound area can be increased, the quantity of the support rods is too little, and the valve leaflets cannot be guaranteed to be smoothly opened and closed by providing enough fixing force for the valve leaflets.

The bracket bar 121 may be located at any position of the connection end 210 of the first bracket. In some embodiments, the valve prosthesis is used to replace a locally diseased native leaflet, the stent body being configured in a non-occluding configuration, such as a scalloped configuration, that can be used in conjunction with a native posterior leaflet when repairing the anterior leaflet of the mitral valve; when repairing the posterior leaflet of the mitral valve, the anterior leaflet can be used together with the primary leaflet. Of course, such a configuration may also be used for aortic or tricuspid valve repair, with the stent body and leaflet assembly 130 being configured according to the subject of the repair.

With continued reference to fig. 1A, the connecting end 210 of the first bracket has two ends (a and E) along the extending direction thereof, and the second bracket 120 is configured with at least two bracket rods 121, and the bracket rods 121 are preferably fixed to the ends of the connecting end 210, and may be fixed to one end of the connecting end 210 or fixed to both ends of the connecting end 210. The frame bars 121 fixed at the ends can form relatively stable support to the leaflet assembly 130 with respect to other positions. In some embodiments, when the leaflet assembly 130 is configured with multiple leaflets, the support rod 121 can also be configured between two adjacent artificial leaflets for securing the two adjacent leaflets. The junction between two adjacent leaflets is configured as a second leaflet fixing portion 135, and the leaflet assembly 130 is further fixed to the support rod 121 through the second leaflet fixing portion 135.

Referring to fig. 1B, the leaflet assembly 130 has three artificial leaflets, a leaflet 131, a leaflet 132 and a leaflet 133, and the edge of the leaflet assembly 130 is configured as the first leaflet fixing portion 134, and a second leaflet fixing portion 135 is respectively configured between the leaflet 131 and the leaflet 132 and between the leaflet 133. The connecting end 210 of the first stent 110 has a first connecting end 211, a second connecting end 212 and a third connecting end 213, and the first connecting end 211 and the third connecting end 213 are symmetrically arranged at two sides of the second connecting end 212, wherein each connecting end is used for fixedly connecting with a leaflet, and each connecting end is configured to have an extension radian matched with the fixed end of the leaflet that is fixed by the connecting end. A support rod 121 is fixed at an end a of the first connection end 211 and an end E of the third connection end 213, and a support rod 121 is disposed at a corresponding position between the first connection end 211 and the second connection end 212, and between the second connection end 212 and the third connection end 213, so that the two ends of the connection end 210 and the adjacent two leaflets are disposed with the support rods 121 therebetween. After the leaflet assembly 130 is fixed, the second leaflet fixing parts 135 are respectively fixed to a frame bar 121. The support rod 121 can provide a fixed position for the valve leaflets, provide corresponding acting force for the opening and closing of the valve leaflets, reduce the opening amplitude of the valve leaflets, and reduce the acting force for beating tissues when the valve leaflets open, so that the service lives of the valve leaflets are prolonged, and meanwhile, the support rod can provide stable support effect for the valve leaflet assembly 130, and the valve leaflets are prevented from being separated from the support rod when being closed.

The second stent 120 may provide a fixation location for the leaflets, alternatively, the fixation location may be anywhere on the stent shaft 121. Specifically, referring to fig. 3, in some embodiments, the stent rod 121 is configured to have a first end 120-1 fixed to the first stent 110, the stent rod 121 further has a leaflet attachment 120-2 for fixing the leaflet, and the distance between the leaflet attachment 120-2 and the end surface of the first end 120-1 is 1/12-1/2 of the length of the stent rod 121. Because the first stent 110 has a larger area, the leaflet assembly 130 is sutured at the middle upper position of the stent rod 121, which is beneficial for the first stent 110 to share the acting force of the leaflet assembly 130 on the stent rod 121.

Further, the leaflet attachment portion 120-2 is configured to have a plurality of suture holes having a diamond shape, a circular shape, a triangular shape, etc., preferably a circular shape, and the circular holes can uniformly distribute the force of the leaflet assembly 130 to the support rod on the support rod 121, thereby increasing the durability of the support rod 121. The number of suture holes may be 1-10, preferably 2-5, and the greater the number of suture holes, the weaker the strength of the stent rod, and the smaller the number of suture holes, the weaker the support force of the stent rod to which the leaflet assembly 130 is subjected.

Further, the first end portion 120-1 may be configured to be a column, such as a cylinder or a prism (such as a quadrangular prism), and preferably, the first end portion 120-1 may be configured to be a horn, as shown in fig. 3, the horn may enable the stent rod 121 and the first stent 110 to be smoothly transited, and may evenly distribute the force applied to the second stent 120 over the entire stent body, thereby increasing the durability of the stent body.

In some embodiments, the free end of the holder bar 121 may be cylindrical, conical, and preferably, the free end of the holder bar 121 is configured as a hook portion 120-3 of a hook shape. The hook part 120-3 at the free end of the support rod 121 can hook the native valve leaflet or tissue, which can play a role in fixing the support main body, and meanwhile, the range of motion of the native valve leaflet is limited, thereby further reducing the risk that the native valve leaflet blocks the outflow tract.

In some preferred embodiments, at least two of the rack bars 121 of the second rack 120 are provided with the hook parts 120-3. The greater the number of hooks 120-3, the greater the force on the native leaflets, preventing them from causing obstruction of the outflow tract during systole. More preferably, the bracket bar 121 provided with the hook portion 120-3 should be symmetrically disposed at both sides of the midpoint C of the connection end 210 of the first bracket. As shown in fig. 1, when the connection rod 120 at the position of the connection end a of the first stent 110 has a hook portion, correspondingly, the connection rod 120 at the position of E also has a hook portion, and the hook portions are symmetrically arranged, so that the acting force of the native valve leaflets or tissues on the stent body is more easily balanced, and the anchoring of the stent is more stable.

In some embodiments, the angle γ of the second support 120 to the first support 110 is 10-175 °, preferably 90-160 °, as shown in fig. 4. At this angle, the first scaffold 110 may be tightly coupled to the atrium, which may provide sufficient anchoring sites for the first scaffold 110.

In a preferred embodiment, the second stent 120 further comprises a leaflet cutting member 140 for cutting the native leaflets, such as when repairing a mitral valve, the larger native leaflets can be cut by the leaflet cutting member 140 to avoid the oversize native leaflets blocking the outflow tract, see fig. 1A and 5. Further, the leaflet cutting member 140 is fixed to the connecting end 210 of the first stent 110 and between two adjacent stent rods 121, and the stent rods 121 at both sides of the leaflet cutting member 140 should be configured with the above-mentioned hook portion, so that after the leaflet cutting member 140 cuts the native leaflet, the native leaflet can be hooked by the stent rods 121 at both sides.

With the side of the leaflet assembly 130 being the inside of the stent body or valve prosthesis, in some embodiments the leaflet cutting element 140 is configured to extend away from the leaflet assembly 130, see fig. 4, the leaflet cutting element 140 extends toward the outside of the stent body, and the angle a between the leaflet cutting element 140 and the direction in which the stent rod 121 extends is 0-90 °; further preferably, the angle α is 0 to 45 °. This design can ensure that the native valve leaflet has been cut open by the leaflet cutting member 140 before the stent rod 121 hooks the native valve leaflet so that the native valve leaflet can be effectively fixed and prevent the outflow tract from being blocked by the oversized valve leaflet. At the same time, the angle keeps the leaflet cutting member 140 away from the leaflet assembly 130, which ensures that the leaflet cutting member 140 does not interfere with the normal opening and closing of the replacement leaflets.

In some embodiments, the leaflet cutting member 140 is configured with a plurality of cutting portions 141, referring to fig. 6A-6D, the cutting portions 141 may be configured as a triangle, a square, or the cutting portions 141 have a circular cutting edge, and the specific form of the cutting portions 141 may be set according to actual clinical requirements. Specifically, in order to prevent the cutting part 141 from damaging the delivery device or the tissue, the cutting part 141 may be configured to have a rounded structure, and further, in order to achieve a better cutting effect, the cutting part 141 may be configured to have a sharp cutting structure, such as a sharp cutting tip, or a blade-shaped cutting portion, in which case, the cutting part 141 may also be made of a degradable material, such as polylactic acid, and may be degraded after the cutting is completed.

In some embodiments, several of the cutting parts 141 are disposed in a continuous manner along the direction in which the leaflet cutting member 140 extends, and referring to fig. 6B and 6C, the cutting parts 141 are sequentially adjacent to each other, and the continuously disposed cutting parts can make the cutting smoother. In some embodiments, several of the cutting portions 141 are arranged in a discontinuous manner, and referring to fig. 6A and 6D, the cutting portions 141 are arranged at intervals, and the discontinuous cutting portions can provide a larger cutting force.

With continued reference to fig. 1, the leaflet cutting element 140 is secured at 1/12-11/12 at the second attachment end 212. preferably, the leaflet cutting element 140 is secured at the midpoint C of the second attachment end 212. This position allows the force of the leaflet cutting member 140 against the first stent 110 to be evenly distributed on the left and right sides of the first stent 110.

In one embodiment, the cutting portion 141 may be configured to be received within the leaflet cutting member 140 in an implanted state, and in use, the cutting portion 141 may be exposed for cutting by operation of a rotatable handle provided.

In some embodiments, the prosthetic valve is used for the total replacement of a mitral valve, a tricuspid valve, or an aortic valve, in which case the stent body should be configured as an annular closed structure. That is, the first stent 110 is configured as an annular closed structure in the circumferential direction, the leaflet assembly 130 is fixed to the inner circumferential side of the annular stent body, and the stent rods 121 of the second stent 120 are arranged in the circumferential direction of the first stent 110. In this case, the stent main body may be made of a balloon expandable material.

Specifically, the two parts of the first bracket 110 and the second bracket 120 are fixedly connected to each other by welding, clamping, sewing or integrally manufacturing. The integral preparation is preferred, the preparation procedures can be reduced, the connection strength is enhanced, and the movable supporting force can be provided for the valve leaflet. The leaflet assembly 130 is fixedly attached to the second frame 120 by means including, but not limited to, welding, clip fastening, or sewing, preferably by sewing. Further, in order to increase the biocompatibility of the second stent 120, a biocompatible material such as PET, PTFE, etc. may be coated on the outside thereof.

The valve prosthesis provided by the embodiment replaces the mesh frame structure in the middle of the lower ventricle and the lower part of the lower ventricle in the prior art due to the design of the stent rod in the second stent 120, reduces the material of the stent main body, and the side of the joint of the leaflet assembly and the second stent is a sparse structure consisting of the stent rod, so that blood is not easy to deposit at the joint, thereby reducing the risk of thrombosis. At the same time, helps to reduce outflow obstruction or obstruction.

While the foregoing is directed to the preferred embodiment of the present invention, it is not intended to detail all of the same, and it is to be understood that these embodiments are merely illustrative of the present invention and are not intended to limit the scope of the invention, which is defined by the claims and their full scope and equivalents.

The embodiments were chosen and described in order to best explain the principles of the invention and the practical application, to thereby enable others skilled in the art to best utilize the invention. Obviously, many modifications and variations are possible in light of the above teaching, and it is contemplated that modifications and variations of the present invention will suggest themselves to those skilled in the art having benefit of this disclosure in practice, and which are intended to be included within the scope of the invention. The technical features in the different embodiments above may be combined arbitrarily without conflict.

Claims (12)

1. A prosthetic valve prosthesis is characterized by comprising a stent main body and a valve leaflet component,

the stand body includes a first stand configured to have a lattice-shaped frame structure, the first stand having a connection end, and a second stand, wherein,

the second support comprises a plurality of support rods, the support rods are fixed to the connecting end of the first support respectively, the valve leaflet assembly is provided with a first valve leaflet fixing portion, and the first valve leaflet fixing portion is fixed to the connecting end of the first support.

2. The prosthetic valve prosthesis of claim 1, wherein the connecting end of the first stent is configured to have a curvature matching the first leaflet fixation portion such that there is a coincidence between the first leaflet fixation portion and the connecting end.

3. The prosthetic valve prosthesis of claim 1, wherein the stent rod is disposed at an end of the connecting end or disposed between two adjacent leaflets.

4. The prosthetic valve prosthesis of claim 3, wherein when the leaflet assembly is configured with a plurality of leaflets, a juncture between two adjacent leaflets is configured as a second leaflet securing portion, the leaflet assembly further being secured to the stent rod by the second leaflet securing portion.

5. The prosthetic valve prosthesis of claim 1, wherein the stent rod is configured to have a first end secured to the first stent, the stent rod further having a leaflet attachment for securing a leaflet, the distance between the leaflet attachment to an end surface of the first end being 1/12-1/2 of the stent rod length.

6. The prosthetic valve prosthesis of claim 1, wherein a free end of at least one of the stent rods is configured as a hook portion for hooking a native leaflet or tissue; preferably, at least two of the support rods of the second support are provided with the hook portions.

7. The prosthetic valve prosthesis of claim 1, wherein the second stent further comprises leaflet cutting elements for cutting native leaflets.

8. The prosthetic valve prosthesis of claim 7, wherein the leaflet cutting element is secured to the connecting end of the first stent between adjacent stent rods.

9. The prosthetic valve prosthesis of claim 7, wherein the leaflet cutting element is configured to extend away from the leaflet assembly and the angle a between the leaflet cutting element and the direction of extension of the stent rod is 0-90 °; preferably, the angle α is 0 to 45 °.

10. The prosthetic valve prosthesis of claim 7, wherein the leaflet cutting element is configured with a number of cutting portions that are configured as triangles, squares, or with rounded cutting edges.

11. The prosthetic valve prosthesis of claim 10, wherein a plurality of the cutting portions are arranged in a continuous manner or a discontinuous manner between a plurality of the cutting portions in a direction in which the leaflet cutting members extend.

12. The prosthetic valve prosthesis of claim 1, wherein the stent body is configured as a non-closed structure or the stent body is configured as a circumferentially closed annular structure.

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