Adjustable heart valve replacement system

Abstract

The invention discloses an adjustable heart valve replacement system. The adjustable heart valve replacement system comprises a single-layer self-expanding valve stent and a spherical self-expanding anchoring stent. Wherein the single-layer self-expanding valve support is provided with a circumferential main support and a skirt frame, the skirt frame is integrally formed at the atrium end of the circumferential support, and the anchoring support abuts against the skirt frame in a split mode. The size of the anchoring support can be adjusted according to different hearts, the anchoring support can adapt to different atrium sizes of a patient, and therefore a better treatment effect is achieved. And the valve stent and the anchoring stent can be conveyed in a split manner, so that a thinner catheter can be conveyed and implanted into a human body, and the expansion of a blood vessel is reduced.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to an adjustable heart valve replacement system. Background Art

[0002] The heart is divided into two parts, each part contains a ventricle and atrium. The ventricles and atria are separated by the ventricular septum and atrial septum. There are valves between the atria to prevent blood backflow. Normal valves only allow blood to flow in one direction in the heart.

[0003] Mitral regurgitation is caused by valvular insufficiency. When the left ventricle contracts, blood flows from the left ventricle into the aorta and the left atrium with less resistance. In addition to receiving blood from the pulmonary veins, the left atrium also receives blood from the left ventricle. Therefore, the increase in left atrial pressure will lead to an increase in pulmonary vein and pulmonary capillary pressure, followed by expansion and congestion. At the same time, the left ventricular diastolic volume load increases, and the left ventricle expands. In acute mitral regurgitation, a large amount of blood suddenly flows back into the left atrium, which can cause a sharp increase in left atrial and pulmonary vein pressure, causing acute pulmonary edema.

[0004] Usually, edge-to-edge repair or mitral valve replacement is used for mitral valve repair. Edge-to-edge repair is to use a clip to clamp the edges of the regurgitant leaflets. For example, the large blood channel originally formed by the leaflets is changed into two small blood channels, that is, the two leaflets are clamped in the middle. For cases that cannot be repaired, replacement surgery is required. In mitral valve replacement surgery, a valve prosthesis is implanted to replace the body's native mitral valve to treat the regurgitation problem caused by mitral valve disease. Currently, mitral valve replacement technology and valve prostheses are in the early exploratory stage, so it is necessary to study and improve the valve prosthesis.

[0005] Mitral valve replacement surgery is divided into traditional surgical surgery and interventional mitral valve replacement surgery. The former has the disadvantages of large trauma, easy infection of wounds, and long recovery time. The difficulty of the latter lies in the unique physiological structure of the mitral valve ring, which leads to the anchoring of the valve prosthesis and difficulty in sealing the paravalvular leak. Everyone's heart is different, and the same fixed size model of the device cannot adapt to the size of the atrium of any different patient. Only other relatively close or suitable devices can be selected to treat the patient, which will limit the device to a certain extent and affect the treatment effect on the patient. The currently disclosed products and patented technologies usually use barbs, apical tethers and other methods for anchoring and sealing, and also use double-layer spherical stent anchoring methods. This double-layer spherical anchoring stent structure cannot adjust the size of the device after implantation in the human body, resulting in it being applicable only to the heart of individual patients. In order to meet the needs of most patients, it is necessary to set up devices of different sizes, which greatly consumes manpower and material resources. In view of the above problems, it is necessary to make changes. Summary of the invention

[0006] In view of the technical problem that the heart valve device with a double-layer spherical anchoring stent in the prior art is difficult to adjust the size of the device according to different heart sizes, the purpose of the present invention is to provide an adjustable heart valve replacement system.

[0007] A first aspect of the present invention provides an adjustable heart valve replacement system, the adjustable heart valve replacement system comprising:

[0008] A self-expanding single-layer valve stent having a circumferential main frame and a skirt frame, wherein the skirt frame is integrally formed at the atrial end of the circumferential stent, and the inflow end of the skirt frame forms an outward expansion structure relative to the outflow end;

[0009] A self-expanding spherical anchoring stent is tightly pressed against the skirt frame, and at least one of the atrial end and the ventricular end of the anchoring stent is provided with a constricting ring for adjusting the size of the anchoring stent.

[0010] In a preferred embodiment of the present invention, the atrial end and the ventricular end of the anchoring stent respectively have an atrial end constricting ring and a ventricular end constricting ring for adjusting the size of the anchoring stent.

[0011] In a preferred embodiment of the present invention, the outer surface of one end of the clamping ring has a plurality of spaced-apart clamps, and the inner surface of the other end of the clamping ring has a plurality of spaced-apart clamps. The clamps are clamped in different clamps to form anchor brackets of different sizes.

[0012] In a preferred embodiment of the present invention, a braided wire frame is provided on the circumferential surface of the anchoring bracket, and the end of the braided wire frame is connected to the constricting ring.

[0013] In a preferred embodiment of the present invention, the end of the braided wire frame is formed by winding the braided wire back and forth on the tightening ring.

[0014] In a preferred embodiment of the present invention, the middle parts of the atrial end constriction ring and the ventricular end constriction ring respectively form mutually symmetrical ring openings which are connected to the inside of the braided wire frame and are located on the same axis, and the anchoring bracket and the valve bracket are coaxially pressed against the skirt frame.

[0015] In a preferred embodiment of the present invention, the braided wire frame is wound back and forth on the tightening ring to form an outer grid and an inner grid, and the grids of the outer grid and the grids of the inner grid are staggered.

[0016] In a preferred embodiment of the present invention, the mesh density of the inner mesh is smaller than the mesh density of the outer mesh; the mesh wire diameter of the inner mesh is larger than the mesh wire diameter of the outer mesh.

[0017] In a preferred embodiment of the present invention, the skirt frame has a plurality of barbs that are expanded outward and arranged at intervals.

[0018] In a preferred embodiment of the present invention, the barb has a skirt end and a ring end, the skirt end is connected to the skirt frame, and the ring end points to the ventricular end.

[0019] In a preferred embodiment of the present invention, the skirt end of the barb is integrally formed and connected to the junction of two adjacent prism-shaped grids of the skirt frame.

[0020] In a preferred embodiment of the present invention, the valve stent has a plurality of delivery rods, one ends of the plurality of delivery rods are respectively arranged on the skirt frame at intervals, and the other ends of the plurality of delivery rods are close to each other.

[0021] In a preferred embodiment of the present invention, the other ends of the plurality of conveying connecting rods respectively have a wire pulling hole.

[0022] In a preferred embodiment of the present invention, one end of the conveying connecting rod is integrally formed and connected to the junction of two adjacent prism-shaped grids of the skirt frame.

[0023] In a preferred embodiment of the present invention, a coating is provided on the inner side of the valve stent, and the valve stent is connected to the leaflet mechanism through the coating.

[0024] A second aspect of the present invention provides a self-expanding spherical anchoring stent for a heart valve replacement system, wherein the anchoring stent is a spherical braided wire frame composed of a plurality of braided grids braided with memory metal wires.

[0025] In a preferred embodiment of the present invention, the two ends of the anchoring stent are respectively provided with an atrial end constriction ring and a ventricular end constriction ring, and the two ends of the braided wire frame are respectively connected to the atrial end constriction ring and the ventricular end constriction ring.

[0026] In a preferred embodiment of the present invention, the middle parts of the atrial end constriction ring and the ventricular end constriction ring respectively form mutually symmetrical ring openings which are connected to the inside of the braided wire frame and are located on the same axis.

[0027] In a preferred embodiment of the present invention, the memory metal wire is wound back and forth on the atrial end constriction ring and the ventricular end constriction ring to form a spherical braided wire frame composed of a plurality of braided grids.

[0028] In a preferred embodiment of the present invention, the memory metal wire is wound back and forth on the atrial end constriction ring and the ventricular end constriction ring to form an outer mesh and an inner mesh, and the braided wire frame includes the outer mesh and the inner mesh.

[0029] In a preferred embodiment of the present invention, the grids of the outer grid layer and the grids of the inner grid layer are staggered.

[0030] In a preferred embodiment of the present invention, the mesh density of the inner mesh is smaller than the mesh density of the outer mesh.

[0031] In a preferred embodiment of the present invention, the diameter of the memory metal wire of the inner grid is greater than the diameter of the memory metal wire of the outer grid; preferably, the diameter of the memory metal wire of the inner grid is 0.3-1 mm, and the diameter of the memory metal wire of the outer grid is 0.1-0.5 mm.

[0032] In a preferred embodiment of the present invention, the memory metal wire is a nickel-titanium alloy wire. Preferably, the diameter of the nickel-titanium alloy wire is 0.1-1 mm, preferably 0.1-0.13 mm.

[0033] In a preferred embodiment of the present invention, a winding wire is wound around the memory metal wire of the woven grid. Preferably, the winding wire is PTFE, PET, TPU or ultra-high molecular weight polyethylene.

[0034] In a preferred embodiment of the present invention, a coating is provided in the area where the anchoring stent contacts the skirt frame of the valve stent.

[0035] The positive and progressive effects of the present invention are:

[0036] 1) The anchoring stent of the adjustable heart valve replacement system of the present invention has constricting rings at both ends, and the size of the device can be adjusted according to the heart size of different patients. As the constricting ring is tightened and relaxed, the outer diameter of the spherical anchoring stent can change. Therefore, the constricting ring can be adjusted according to preoperative data to optimize the size of the anchoring stent. After the anchoring stent is implanted in the human body, the anchoring stent can adapt to the different atrium sizes of the patient, thereby achieving a better treatment effect.

[0037] 2) The valve stent of the adjustable heart valve replacement system of the present invention is a single-layer self-expanding stent, which is conducive to compression and gripping delivery, rather than relying on the circumferential main frame of the valve to seal with the native leaflets. Therefore, there is no need to capture the native leaflets, reducing the difficulty of valve stent implantation. At the same time, it will not constrain the contraction and expansion movement of the native valve ring, and will not cause the movement of the valve ring to be restricted.

[0038] 3) The anchoring stent of the adjustable heart valve replacement system of the present invention is in the shape of a hollow sphere. After being implanted into the atrium, the skirt frame structure of the valve stent is always pressed against the area above the physiological valve ring by utilizing the rigidity of the anchoring stent after self-expansion, so that the skirt frame structure of the valve stent is more closely fitted to the physiological valve ring, thereby increasing the sealing effect.

[0039] 4) The valve stent and anchoring stent of the adjustable heart valve replacement system of the present invention can be delivered separately, with a small compression diameter, which is convenient for delivery and implantation through the femoral route or the like. The two are delivered separately and enter the human body in steps, so that a thinner catheter can be used for delivery and implantation into the human body, thereby reducing the expansion of blood vessels. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] The disclosure of the present invention will become more apparent with reference to the accompanying drawings. It should be understood that these drawings are only for illustrative purposes and are not intended to limit the scope of protection of the present invention. In the drawings:

[0041] Figure 1A is a schematic structural diagram of an adjustable heart valve replacement system 10 of the present invention;

[0042] Figure 1B for Figure 1A The main view;

[0043] Figure 2 It is a schematic structural diagram of the spherical self-expanding anchoring stent 22 of the present invention;

[0044] Figure 3A for Figure 2 A partial enlarged view of

[0045] Figure 3B It is a schematic structural diagram of the converging ring 221 of the present invention;

[0046] Figure 3C for Figure 3B The main view;

[0047] Figure 3D for Figure 3C A partial enlarged view of

[0048] Figure 4A A schematic structural diagram of a self-expanding single-layer valve stent 21 of the present invention;

[0049] Figure 4B for Figure 4A A schematic diagram of a structure with an artificial valve leaflet built into the body;

[0050] Figure 5A Another structural schematic diagram of the self-expanding single-layer valve stent 21 of the present invention;

[0051] Figure 5B for Figure 5A A partial enlarged view of

[0052] Figure 5C for Figure 5B Schematic diagram of the equivalent replacement of the barb with another structure;

[0053] Figure 6It is a structural schematic diagram of a valve stent 21 of the present invention having a coating 2123 on the skirt frame 212;

[0054] Figure 7 This is a schematic diagram of the adjustable heart valve replacement system 10 of the present invention being installed in the heart.

[0055] Description of reference numerals:

[0056] 10. Adjustable heart valve replacement system, 21. Valve stent, 22. Anchoring stent, 211. Circumferential main frame, 212. Skirt frame, 2121. Barbs, 2122. Delivery connecting rod, 2121a. Skirt end, 2121b. Insert ring end, 2123. Cover, 213. Leaflet mechanism, 221. Closure ring, 221a. Atrial end closing ring, 221b. Ventricular end closing ring, 2211. Clamp, 2212. Clamp, 222. Braided wire frame, 223. Braided mesh. DETAILED DESCRIPTION

[0057] The following describes the embodiments of the present invention through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention.

[0058] It should be noted that the following embodiments and features therein may be combined with each other if there is no conflict.

[0059] In the description of the present invention, it should be noted that directional words such as the terms "outside", "middle", "inside", "outside", etc., which indicate directions and positional relationships, are based on the directions or positional relationships shown in the drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and cannot be understood as limiting the specific protection scope of the present invention.

[0060] In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features. Therefore, the definition of "first" and "second" features can explicitly or implicitly include one or more of the features. In the description of the present invention, "several" and "a number" mean two or more, unless otherwise clearly and specifically defined.

[0061] In the present application, when describing an anchoring stent or a valve stent, "inflow end" and "outflow end" are used as directional words, which are commonly used terms in the field of interventional medical devices, where "inflow end" means the end where antegrade blood first flows into the interventional medical device, such as the upper end in Figure 1. "Outflow end" means the end where antegrade blood flows out of the interventional medical device, such as the lower end in Figure 1. In the present application, the "inflow end" has the same orientation as the "atrial end", such as Figure 7 The upper end of the ventricle, the “outflow end” and the “ventricular end” have the same orientation, e.g. Figure 7 The lower end of .

[0062] like Figure 1A and Figure 1B As shown, the adjustable heart valve replacement system 10 of the present invention comprises: a self-expanding single-layer valve stent 21 that is easy to press and grasp for delivery, and a self-expanding spherical anchoring stent 22 that ensures the valve stent 21 has a stable posture. Among them, the self-expanding single-layer valve stent 21 has a straight-cylindrical circumferential main frame 211 and a flared skirt frame 212. The skirt frame 212 is integrally formed at the atrial end of the circumferential stent 211, and the anchoring stent 22 is split and tightly pressed against the skirt frame 212. At least one of the two ends of the anchoring stent 22 also has a closing ring 221. Preferably, both ends of the anchoring stent 22 have a closing ring 221, that is, the atrial end closing ring 221a and the ventricular end closing ring 221b that can adjust the size of the anchoring stent 22 are respectively provided at the atrial end and the ventricular end, so that the size of the two ends of the anchoring stent 22 can be better adjusted, so as to achieve more accurate control of the external dimensions of the anchoring stent 22, such as an anchoring stent with an external contour that is small at the top and large at the bottom, large at the top and small at the bottom, or small at the top and small at the bottom. The constricting rings 221 at both ends of the anchoring stent 22 of the adjustable heart valve replacement system 10 of the present invention can adjust the size of the device according to the heart size of different patients. As the constricting ring 221 is tightened and relaxed, the outer diameter of the spherical anchoring stent 22 can change. Therefore, the constricting ring 221 can be adjusted according to preoperative data to optimize the size of the anchoring stent 22. After the anchoring stent 22 is implanted in the human body, the anchoring stent 22 can adapt to the different atrium sizes of the patient, thereby achieving a better treatment effect.

[0063] like Figure 2 As shown, the anchoring stent 22 is a hollow spherical self-expanding structure. The anchoring stent 22 can self-expand, and then after being implanted in the human body, it can expand and press the skirt frame 212 of the valve stent 21, so that the valve stent 21 and the physiological valve ring are more closely fitted, thereby increasing the sealing performance. The anchoring stent 22 with a spherical structure has a large rigidity. After being implanted into the atrium, the spherical rigidity after self-expansion can be used to press the skirt frame 212 of the valve stent 21 tightly against the physiological valve ring on one side of the atrium, thereby ensuring the stability of the valve stent 21, that is, the anchoring stent 22 is the main anchoring structure of the valve stent 21.

[0064] Everyone's heart is different, and the model of the device cannot infinitely adapt to the atrial size of any different patient. We can only choose a relatively close or appropriate device specification to treat the patient, which will affect the treatment effect of the device on the patient to a certain extent. In this example, if Figure 3A As shown, in order to adapt to different heart sizes of different patients, a constriction ring 221 that can adjust the size of the anchoring stent 22 is provided at at least one end of the two ends of the anchoring stent 22. Preferably, an atrial end constriction ring 221a and a ventricular end constriction ring 221b that can adjust the size of the anchoring stent 22 are provided at both the atrial end and the ventricular end, respectively. The constriction ring 221 can adjust the size of the anchoring stent 22 according to different heart sizes. With the tightening and loosening of the constriction ring 221, the size of the anchoring stent 22 can be changed. Then, according to the preoperative data, the constriction ring 221 can be adjusted to optimize the size of the anchoring stent 22. After the anchoring stent 22 is implanted in the human body, it can adapt to the different atrial sizes of the patient, thereby achieving a better treatment effect.

[0065] The constriction ring can be any ring that can be enlarged or reduced and can be controlled to any desired size. In one example, Figure 3B and Figure 3C As shown, the tightening ring 221 is an anchoring structure of a clamp 2211 and a clamp ring 2212. Specifically, as Figure 3D As shown, the structure of the closing ring 221 is designed in the following manner: the two ends of the closing ring 221 are respectively provided with a clamp 2211 and a clasp 2212, specifically, the outer surfaces of one end of the atrial closing ring 221a and the ventricular closing ring 221b are respectively provided with a plurality of clamps 2211 arranged at intervals, and the inner surfaces of the other ends of the atrial closing ring 221a and the ventricular closing ring 221b are respectively provided with a plurality of clasps 2212 arranged at intervals, wherein the clamp 2211 at one end can be clamped in different clasps 2212 to form closing rings of different sizes to control the size of the anchoring bracket 22, thereby the size of the anchoring bracket 22 can be adjusted according to the hearts of different patients. In another example, the constriction ring 221 can be a simple constriction ring with an adjustable ring length made of a suture or nickel-titanium wire. The two ends of the anchoring stent 22 can be contracted or expanded by tightening or loosening the ring length, thereby adjusting the size of the anchoring stent 22 according to the heart size of different patients.

[0066] Continue as Figure 2 and Figure 3AAs shown, the anchoring stent 22 is a self-expanding spherical structure composed of a plurality of woven meshes 223, each of which is a rhombus-like shape, and a plurality of woven meshes 223 together constitute a woven wire frame 222 on the circumference of the anchoring stent 22. Of course, the woven meshes 223 can also be in other shapes. The size of each woven mesh 223 can be the same or different, which is specifically determined by the natural shape of the woven mesh. The braided mesh 223 is surrounded by a plurality of braided wires, and the ends of the braided wire frame 222 are connected to the constriction ring 221, that is, the ends of the braided wire frame 222 are formed by the braided wire winding back and forth on the constriction ring 221a at the atrial end and the constriction ring 221b at the ventricular end, and then the braided wire frame 222 is a spherical structure with a plurality of adjacent rhombus-shaped braided meshes 223. The braided wires here can be memory metal materials, that is, the braided wire frame 222 of the anchoring stent 22 is woven with memory metal wires, and this material enables the anchoring stent 22 to be released at will without blocking the blood circulation in the atrium. The two ends of the braided wire frame 222 are respectively connected to the constriction ring 221a at the atrial end and the constriction ring 221b at the ventricular end, so that the middle parts of the constriction ring 221a at the atrial end and the constriction ring 221b at the ventricular end form mutually symmetrical ring openings that are connected to the inside of the braided wire frame 222 and are located on the same axis. That is, in the process of weaving the braided wire frame 222, a ring opening is respectively reserved at the atrial end and the ventricular end, so that the atrial end and the ventricular end of the anchoring stent 22 form symmetrical ring openings that are conducive to blood circulation.

[0067] In one example, the anchoring stent 22 is a single-layer structure, and the braided wire frame 222 is woven with memory metal braided wire, that is, the memory metal wire is wound back and forth on the atrial end constriction ring 221a and the ventricular end constriction ring 221b to form a spherical braided wire frame 222 composed of a number of braided grids 223. For example, the memory metal wire is a nickel-titanium alloy wire, which realizes the arbitrary release of the anchoring stent 22, that is, it will not block the circulation of blood in the atrium, such as the pulmonary vein blood through the left atrium. In this example, the diameter of the nickel-titanium alloy wire can be 0.1 to 1 mm. Preferably, the diameter of the nickel-titanium alloy wire is 0.1-0.13 mm. Such a design ensures that the anchoring stent 22 has a supporting force, and the relatively thin nickel-titanium alloy wire reduces its influence on the blood flow, allowing the blood to pass smoothly.

[0068] In another example, in order to increase the rigidity and support force of the anchoring stent 22 and provide sufficient compression force for the skirt frame 212 of the valve stent 21, the braided wire frame 222 can be a multi-layer structure, and the braided wire frame 222 is described as a double-layer structure here. The braided wire frame 222 is woven with memory metal braided wires, and the memory metal wires on the braided wire frame 222 are wound back and forth on the atrial end constriction ring 221a and the ventricular end constriction ring 221b to form a double-layer structure divided into an outer grid and an inner grid, that is, the braided wire frame 222 includes an outer grid and an inner grid, and the outer grid and the inner grid are respectively composed of a plurality of braided grids 223. In this example, the grids of the outer grid and the inner grid are staggered, and the grid density of the inner grid is less than the grid density of the outer grid. In some examples, the memory metal wire is nickel-titanium wire, and the diameter of the memory metal wire of the inner mesh is larger than the diameter of the memory metal wire of the outer mesh. Preferably, the diameter of the memory metal wire used in the inner mesh is 0.3-1mm, and the diameter of the memory metal wire used in the outer mesh is 0.1-0.5mm. Generally, the diameter of the memory metal wire of the inner mesh is larger than the diameter of the memory metal wire of the outer mesh, because the thicker inner mesh can provide greater radial support force with a smaller mesh density (the number of meshes per unit area), thereby reducing the impact on blood flow.

[0069] In another example, a winding wire is provided on the memory metal wire of the woven mesh 223 of the anchoring stent 22 to promote endothelialization of the anchoring stent 22 and the atrium, and the winding wire can be one or more of PTFE, PET, TPU, and ultra-high molecular weight polyethylene.

[0070] In another example, when controlling the release direction of the anchoring stent 22, a coating can be added to the area where the anchoring stent 22 contacts the skirt frame 212 of the valve stent 21 to improve the sealing performance, and the coating cannot affect the blood entering the valve stent 21. Of course, it is not a necessary structure, and the coating may not be added.

[0071] like Figure 4AAs shown, the valve stent 21 includes an integrally connected circumferential main frame 211 and a skirt frame 212 from the ventricular end to the atrial end. The circumferential main frame 211 of the valve stent 21 is a straight-cylindrical stent composed of a plurality of prism-like grids in the circumferential direction, and is a stent structure for fixing an artificial valve leaflet. In this example, each prism-like grid of the circumferential main frame 211 has an inflow end, an outflow end, and two side ends, and the side ends of each prism-like grid in the circumferential direction of the circumferential main frame 211 are integrally connected with the side ends of the adjacent prism-like grids, thereby forming the circumferential stent 211. The side ends of the prism-like grids on the upper part of the circumferential main frame 211 also have the function of connecting with the leaflet mechanism 213. The skirt frame 212 of the valve stent 21 is an expanded skirt-shaped stent composed of a plurality of prism-like grids in the circumferential direction. In this example, each prism-like grid of the skirt frame 212 also has an inflow end, an outflow end, and two side ends. The inflow end of each prism-like grid of the skirt frame 212 forms an outward expansion structure relative to the outflow end. The side ends of each prism-like grid on the circumference of the skirt frame 212 are respectively connected to the side ends of the adjacent prism-like grids in an integral manner, thereby forming the skirt frame 212. At the same time, the outflow end of the prism-like grid of the skirt frame 212 is connected to the inflow end of the corresponding prism-like grid of the circumferential main frame 211 in an integral manner, so that the outflow end of the skirt frame 212 is arranged on the inflow end of the circumferential frame. Therefore, the entire valve support 21 is an integrally formed structure. The number of prism-like grids in the skirt frame 212 can be an integer multiple of the number of prism-like grids in the circumferential main frame 211. The specific number belongs to conventional design in the art and does not require creative labor. For example, in this example, the number of prism-like grids in the skirt frame 212 is equal to the number of prism-like grids in the circumferential main frame 211. After the valve stent 21 of this example is implanted in the heart, the skirt frame 212 will fit together with the position of the physiological valve ring located on one side of the atrium. The valve stent 21 is a single-layer self-expanding stent, which is convenient for compression and gripping delivery, rather than relying on the circumferential main frame 211 to seal with the native valve leaflets. Therefore, there is no need to capture the native valve leaflets, which reduces the difficulty of implanting the valve stent 21. Since the valve stent 21 does not require the physiological valve ring to provide radial support force, that is, it does not need to capture the native valve leaflets or rely on the native valve leaflets to seal, a double-layer structure is not required. If it is a double-layer structure, the outer layer needs to adapt to or capture the native valve leaflets, and the inner layer needs to be connected to the artificial valve leaflets, so the outer layer inevitably expands the native valve leaflets or valve ring. Therefore, in the present application, the valve stent 21 is preferably a self-expanding single-layer stent, and the valve stent 21 of this example will not restrict the contraction and expansion movement of the native valve ring, and will not cause the movement of the valve ring to be restricted.

[0072] In this example, if Figure 4BAs shown, the inner side of the valve stent 21 is used to accommodate and connect the leaflet mechanism 213, which has a plurality of artificial leaflets. The artificial leaflets are connected to the inner side of the circumferential main frame 211 of the valve stent 21, and are preferably arranged on the side ends of some prismatic grids of the circumferential main frame 211, that is, on the main rod at the connection between two adjacent prismatic grids.

[0073] In another example, if Figure 5A As shown, the skirt frame 212 of the valve stent 21 has a plurality of barbs 2121 arranged at intervals and expanding outward, and the barbs 2121 are inserted into the physiological valve ring position. It is used to fix the valve stent 21 and ensure that the valve stent remains stable after being implanted in the human heart. Of course, in the case of stable anchoring of the anchoring stent 22, the barbs 2121 on the skirt frame 212 are not necessary structures. The barbs 2121 on the skirt frame 212 enable the valve stent 21 to remain more stable after being implanted in the heart.

[0074] In this example, if Figure 5B As shown, the barb 2121 has a skirt end 2121a and a ring end 2121b, and the skirt end 2121a is connected to the skirt frame 212, that is, the skirt end 2121a of the barb 2121 is integrally formed and spacedly connected to the junction of two adjacent prism-like grids of the skirt frame 212, that is, the side end connection of two adjacent prism-like grids on the skirt frame 212, and the ring end 2121b extends out of the outer surface of the skirt frame 212. The skirt frame 212 is an outward expansion structure, and the barb 2121 is further outwardly expanded relative to the skirt frame 212. The outward expansion of the ring end 2121b extending out of the outer surface of the skirt frame 212 facilitates the insertion of the barb 2121 into the physiological valve ring. In another example, as Figure 5C As shown, after the barbs 2121 extend outward from the outer surface of the skirt frame 212, the barbs 2121 further turn outward so that the insert ring end 2121b points to the ventricular end, which is conducive to the barbs 2121 being directly inserted into the physiological valve ring on the atrium side, and can increase the stability of the valve stent 21 after implantation. In this example, the number of barbs can refer to the number of barbs on the valve stent in the prior art, and can also be reasonably set according to the stability requirements of inserting into the physiological valve ring, and those skilled in the art do not need to make creative efforts for this.

[0075] In another example, the skirt frame 212 of the valve stent 21 has a plurality of transport links 2122 arranged at intervals. The transport links 2122 on the skirt frame 212 are used to connect to the heart valve replacement system transporter to increase the stability of the valve stent 21 during the release process. Of course, the transport links 2122 are not a necessary structure. When the transport links 2122 are not provided, the skirt frame 212 can be directly connected with a plurality of pull wires to increase the stability of the valve stent 21 during the release process, and prevent the valve stent 21 from jumping out of the transporter catheter in the final stage of release, causing the implantation posture of the valve stent 21 to be skewed. Figure 5A As shown, one end of a plurality of conveying links 2122 is spaced apart on the skirt frame 212, that is, one end of the conveying link 2122 is spaced apart at the junction of two adjacent quasi-prism grids of the skirt frame 212 without barbs 2121, that is, the side end connection. In other words, only one of the barbs 2121 and the conveying link 2122 is connected at the junction between the two adjacent quasi-prism grids. The other ends of the plurality of conveying links 2122 are close to each other, that is, the other ends of the conveying links 2122 are concentrated and gathered at the inner center of the valve support 21. At the same time, the other ends of the plurality of conveying links 2122 are respectively provided with a wire hole 2122a for passing the wire through, thereby further increasing the stability of the release of the valve support 21, and also preventing the pop-out deformation of the plurality of conveying links 2122. In this example, the number of the conveying links 2122 can be reasonably set according to the stability requirements during the conveying process, such as 3, or other numbers, and those skilled in the art do not need to work creatively for this.

[0076] like Figure 6 As shown, in this example, there is a coating 2123 on the inner side of the skirt frame 212, which can improve the sealing performance; this is because the artificial valve leaflet is directly connected to the connecting rod of the prismatic grid of the valve stent 21, and the valve stent is very prone to paravalvular leakage (when the valve leaflet mechanism 213 is closed, blood flows back to the inflow end through the outer side of the valve stent 21), so the artificial valve leaflet is connected to the valve stent 21 through the coating 2123, and the inflow end of the coating here at least extends to the middle of the skirt frame 212 of the valve stent 21, preferably, the inflow end of the coating 2123 extends to the inflow end of the skirt frame 212 of the valve stent 21, and further, the inflow end of the coating 2123 exceeds the inflow end of the skirt frame 212 by 1mm to 5mm, and the excess coating 2123 is folded to the outside of the valve stent 21; the outflow end of the coating 2123 is at least connected to the edge of the inflow end of the artificial valve leaflet. In some embodiments, the coating 2123 located on the inner side of the valve support 21 extends to the outflow end of the circumferential main frame 211, so that the valve support 21 can be coated as a whole. In another example, the inner and outer sides of the skirt frame 212 are provided with coatings 2123, and a TPU coating is provided on the inner side of the coating 2123 to prevent blood from penetrating through the gaps in the coating 2123.

[0077] like Figure 7As shown, the valve stent 21 and the anchoring stent 22 can be delivered separately, and the compression grip diameter is small, which is convenient for delivery and implantation through the femoral route. The two are delivered separately and enter the human body in steps, so that a thinner catheter can be used to deliver and implant into the human body, reducing the expansion of the blood vessels. The anchoring stent 22 is coaxially pressed against the skirt frame 2121 of the valve stent 21, that is, the mutually symmetrical ring openings located on the same axis of the anchoring stent 21 are coaxially placed with the central axis of the valve stent 21, which is convenient for blood circulation. The self-expanded rigidity of the anchoring stent 22 can be used to press the skirt frame 212 of the valve stent 21 on the physiological valve ring at all times, so that the skirt frame 212 of the valve stent 21 is more closely fitted with the physiological valve ring on the atrium side, thereby increasing the sealing effect and ensuring the stability of the valve stent 21.

[0078] The present invention is described in detail above in conjunction with the embodiments of the drawings, and those skilled in the art can make various variations of the present invention according to the above description. Therefore, certain details in the embodiments should not constitute limitations on the present invention, and the present invention shall be protected by the scope defined by the attached claims.

Claims

1. An adjustable heart valve replacement system, characterized in that The adjustable heart valve replacement system comprises: A self-expanding single-layer valve stent having a circumferential main frame and a skirt frame, wherein the skirt frame is integrally formed at the atrial end of the circumferential stent, and the inflow end of the skirt frame forms an outward expansion structure relative to the outflow end; A self-expanding spherical anchoring stent is tightly pressed against the skirt frame, and at least one of the atrial end and the ventricular end of the anchoring stent is provided with a constricting ring for adjusting the size of the anchoring stent.

2. The adjustable heart valve replacement system as claimed in claim 1, characterized in that The atrial end and the ventricular end of the anchoring stent are respectively provided with an atrial end constriction ring and a ventricular end constriction ring for adjusting the size of the anchoring stent.

3. The adjustable heart valve replacement system according to claim 1 or 2, characterized in that The outer surface of one end of the clamping ring has a plurality of spaced-apart clamps, and the inner surface of the other end of the clamping ring has a plurality of spaced-apart clamps. The clamps are clamped in different clamps to form anchor brackets of different sizes.

4. The adjustable heart valve replacement system as claimed in claim 1, characterized in that A braided wire frame is provided on the circumferential surface of the anchoring bracket, and the end of the braided wire frame is connected to the constricting ring.

5. The adjustable heart valve replacement system as claimed in claim 4, characterized in that The braided wire frame end is formed by winding the braided wire back and forth on the tightening ring.

6. The adjustable heart valve replacement system as claimed in claim 4, characterized in that The middle parts of the atrial end constriction ring and the ventricular end constriction ring respectively form mutually symmetrical ring openings which are connected to the inside of the braided wire frame and are located on the same axis. The anchoring bracket and the valve bracket are coaxially pressed against the skirt frame.

7. The adjustable heart valve replacement system as claimed in claim 5, characterized in that The braided wire frame is wound back and forth on the tightening ring to form an outer grid and an inner grid, and the grids of the outer grid and the grids of the inner grid are staggered.

8. The adjustable heart valve replacement system according to claim 7, characterized in that The mesh density of the inner mesh layer is smaller than that of the outer mesh layer; and the mesh wire diameter of the inner mesh layer is larger than that of the outer mesh layer.

9. The adjustable heart valve replacement system according to claim 1, characterized in that The skirt frame has a plurality of outwardly expanding barbs arranged at intervals.

10. The adjustable heart valve replacement system according to claim 9, characterized in that The barb has a skirt end and a ring end, wherein the skirt end is connected to the skirt frame, and the ring end points to the ventricle end.

11. The adjustable heart valve replacement system according to claim 9 or 10, characterized in that The skirt end of the barb is integrally formed and connected to the junction of two adjacent prism-shaped grids of the skirt frame.

12. The adjustable heart valve replacement system of claim 1, wherein The valve support has a plurality of conveying connecting rods, one ends of which are arranged on the skirt frame at intervals, and the other ends of which are close to each other.

13. The adjustable heart valve replacement system of claim 12, wherein The other ends of the plurality of conveying connecting rods are respectively provided with wire pulling holes.

14. The adjustable heart valve replacement system according to any one of claims 12 to 13, characterized in that One end of the conveying connecting rod is integrally formed and connected to the junction of two adjacent prism-shaped grids of the skirt frame.

15. The adjustable heart valve replacement system of claim 1, wherein A covering is provided on the inner side of the valve stent, and the valve stent is connected to the leaflet mechanism through the covering.

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