Adjustable heart valve replacement system

Abstract

The application discloses an adjustable heart valve replacement system, which comprises a single-layer self-expanding valve support and a spherical self-expanding anchoring support. The single-layer self-expanding valve support has a circumferential main support and a skirt support, the skirt support is integrally formed at an atrium end of the circumferential support, and the anchoring support is detachably abutted on the skirt support. The anchoring support can be adjusted in size according to different hearts, so that the anchoring support can adapt to different atrium sizes of patients, and thus a better treatment effect can be achieved. The valve support and the anchoring support can be delivered in a detachable mode, so that a thinner catheter can be used to deliver and implant into a human body, and the expansion of the blood vessel can be reduced.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to an adjustable heart valve replacement system. BACKGROUND

[0002] The heart is divided into left and right halves, each containing one ventricle and atrium, and the ventricles and atria are separated by the interventricular septum and interatrial septum, and there are valves between the atria and ventricles to prevent blood from flowing backward. Normal valves only allow blood to flow in one direction in the heart.

[0003] Among them, mitral regurgitation is due to valve 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 vein, 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, and then to dilation and congestion. At the same time, the left ventricular diastolic volume load increases, and the left ventricle enlarges. In the case of acute mitral valve insufficiency, the left atrium suddenly increases the amount of regurgitant blood, which can cause a sharp rise in left atrial and pulmonary vein pressure, leading to acute pulmonary edema.

[0004] Generally, the current method is to repair the mitral valve or replace the mitral valve. The edge-to-edge repair method uses a clip to clamp the edges of the regurgitant leaflet. For example, the large blood passage originally formed by the leaflet is changed into two small blood passages, i.e. clamping in the middle of the two leaflets. In the case of repair, replacement surgery is needed. In mitral valve replacement surgery, a valve prosthesis is implanted to replace the native mitral valve to treat regurgitation caused by mitral valve disease. The current mitral valve replacement technology and valve prosthesis are still in the early stages of exploration, so it is necessary to improve the valve prosthesis.

[0005] Mitral valve replacement surgery is divided into traditional surgery and interventional mitral valve replacement surgery. The former has the disadvantages of large trauma, wound infection, and long recovery time. The difficulty of the latter lies in the unique physiological structure of the mitral annulus, which makes it difficult to anchor and seal the valve prosthesis. Each person's heart is different, and a fixed size device cannot be used for any different patient's atrium. Only other relatively close or suitable devices can be selected for treatment, which will limit the device and affect the treatment effect. The currently disclosed products and patent technologies usually use barbs, apex ropes, etc. to anchor and seal, and also use a double-layer spherical stent anchoring method. The structure of this double-layer spherical anchoring stent cannot adjust the size of the device after being implanted into the human body, which can only be used for individual patients. In order to meet the needs of most patients, different sizes of devices need to be set, which greatly consumes manpower and resources. In view of the above problems, it is necessary to improve them. SUMMARY

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

[0007] The first aspect of the present application provides an adjustable heart valve replacement system, which comprises:

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

[0009] a self-expanding ball-shaped anchoring stent abutting against the skirt frame, at least one end of the atrial end and the ventricular end of the anchoring stent having a size-adjustable constriction ring.

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

[0011] In a preferred embodiment of the present application, one end of the constriction ring has a plurality of spaced clamping heads on the outer surface, and the other end of the constriction ring has a plurality of spaced clamping rings on the inner surface, the clamping heads being clamped in different clamping rings to form anchoring stents of different sizes.

[0012] In a preferred embodiment of the present application, the anchoring stent has a woven wire frame on the circumferential surface, and the end of the woven wire frame is connected with the constriction ring.

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

[0014] In a preferred embodiment of the present application, the middle part of the atrial end constriction ring and the ventricular end constriction ring respectively forms a mutually symmetrical ring opening in communication with the inside of the woven wire frame and located on the same axis line, and the anchoring stent is coaxially abutted against the skirt frame.

[0015] In a preferred embodiment of the present application, the woven wire frame is wound back and forth on the constriction ring to form an outer layer mesh and an inner layer mesh, and the meshes of the outer layer mesh are arranged in a staggered manner with the meshes of the inner layer mesh.

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

[0017] In a preferred embodiment of the present application, the skirt frame has a plurality of outwardly extending barbs arranged at intervals.

[0018] In a preferred embodiment of the present application, the barbs have skirt-connecting ends and ring-inserting ends, the skirt-connecting ends being connected to the skirt frame, and the ring-inserting ends pointing to the ventricular end.

[0019] In a preferred embodiment of the present application, the skirt-connecting ends of the barbs are integrally connected to the skirt frame at the junctions of adjacent two prismatic meshes.

[0020] In a preferred embodiment of the present application, the valve support has a plurality of delivery links, one end of each of the delivery links being arranged at intervals on the skirt frame, and the other ends of the delivery links being close to each other.

[0021] In a preferred embodiment of the present application, the other ends of the delivery links each have a pull wire hole.

[0022] In a preferred embodiment of the present application, one end of the delivery link is integrally connected to the skirt frame at the junction of adjacent two prismatic meshes.

[0023] In a preferred embodiment of the present application, the valve support has a covering film arranged on the inner side of the valve support, and the valve support is connected to the valve leaflet mechanism through the covering film.

[0024] The second aspect of the present application provides a self-expanding spherical anchor support for a heart valve replacement system, the anchor support being a spherical woven wire frame formed by weaving a plurality of woven meshes with memory metal wires.

[0025] In a preferred embodiment of the present application, the anchor support has an atrial end constriction ring and a ventricular end constriction ring at two ends thereof respectively, and the two ends of the woven wire frame are connected to the atrial end constriction ring and the ventricular end constriction ring respectively.

[0026] In a preferred embodiment of the present application, the atrial end constriction ring and the ventricular end constriction ring each have a middle part forming a mutually symmetrical ring opening in communication with the inside of the woven wire frame and located on the same axis.

[0027] In a preferred embodiment of the present application, the memory metal wires are wound back and forth on the atrial end constriction ring and the ventricular end constriction ring to form the spherical woven wire frame composed of a plurality of woven meshes.

[0028] In a preferred embodiment of the present application, the memory metal wires are 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 woven wire frame comprises the outer mesh and the inner mesh.

[0029] In a preferred embodiment of the present application, the meshes of the outer layer mesh are arranged in a staggered manner with the meshes of the inner layer mesh.

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

[0031] In a preferred embodiment of the present application, the diameter of the memory wire of the inner layer mesh is larger than the diameter of the memory wire of the outer layer mesh; preferably, the diameter of the memory wire of the inner layer mesh is 0.3-1mm, and the diameter of the memory wire of the outer layer mesh is 0.1-0.5mm.

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

[0033] In a preferred embodiment of the present application, the memory wire of the braided mesh is wound with a winding wire, preferably, the winding wire is PTFE, PET, TPU or ultra-high molecular weight polyethylene.

[0034] In a preferred embodiment of the present application, a film is arranged on the area where the anchoring support contacts the skirt frame of the valve support.

[0035] The positive progress effect of the present application is that:

[0036] 1) The two ends of the anchoring support of the adjustable heart valve replacement system of the present application have constriction rings, which can adjust the size of the device according to the size of the heart of different patients, and the change of the outer diameter size of the spherical anchoring support can be realized by tightening and loosening the constriction rings, so that the size of the anchoring support can be adjusted to the best according to the preoperative data, and the anchoring support can adapt to different atrial sizes of patients after being implanted into the human body, thereby achieving a better treatment effect.

[0037] 2) The valve support of the adjustable heart valve replacement system of the present application is a single-layer self-expanding support, which is beneficial to compression and delivery, and does not rely on the sealing of the valve circumferential main frame and the native valve leaflet, so it does not need to capture the native valve leaflet, thereby reducing the difficulty of implanting the valve support, and at the same time, it will not restrict the contraction and expansion movement of the native valve ring, and will not cause the limitation of the valve ring movement.

[0038] 3) The anchoring support of the adjustable heart valve replacement system of the present application is a hollow spherical body, which is implanted into the atrium, and the rigidity of the anchoring support after self-expansion always presses the skirt frame structure of the valve support in the area above the physiological valve ring, so that the skirt frame structure of the valve support is more fitted with the physiological valve ring, thereby increasing the sealing effect.

[0039] 4) The valve support and anchoring support of the adjustable heart valve replacement system of the present application can be delivered separately, with a small compressed diameter, facilitating delivery and implantation through the femoral artery and the like. The two are delivered separately and step by step into the human body, allowing for the use of a thinner catheter for delivery and implantation into the human body, reducing the expansion of the blood vessels. BRIEF DESCRIPTION OF DRAWINGS

[0040] The disclosure of the present application will become more apparent from the following description, with reference to the accompanying drawings. It should be understood that the drawings are only for the purpose of illustration and are not intended to limit the scope of protection of the present application. In the drawings:

[0041] Figure 1A Fig. 1 is a schematic diagram of the structure of the adjustable heart valve replacement system 10 of the present application;

[0042] Figure 1B Fig. 2 is a front view of the adjustable heart valve replacement system 10 of the present application; Figure 1A

[0043] Figure 2 Fig. 3 is a schematic diagram of the structure of the ball-shaped self-expanding anchoring support 22 of the present application;

[0044] Figure 3A Fig. 4 is an enlarged view of a portion of the ball-shaped self-expanding anchoring support 22 of the present application; Figure 2

[0045] Figure 3B Fig. 5 is a schematic diagram of the structure of the converging ring 221 of the present application;

[0046] Figure 3C Fig. 6 is a front view of the converging ring 221 of the present application; Figure 3B

[0047] Figure 3D Fig. 7 is an enlarged view of a portion of the converging ring 221 of the present application; Figure 3C

[0048] Figure 4A Fig. 8 is a schematic diagram of one structure of the self-expanding single-layer valve support 21 of the present application;

[0049] Figure 4B Fig. 9 is a schematic diagram of one structure of the self-expanding single-layer valve support 21 of the present application with an artificial valve leaflet built-in; Figure 4A

[0050] Fig. 10 is another schematic diagram of the self-expanding single-layer valve support 21 of the present application; Figure 5A

[0051] Figure 5B Fig. 11 is an enlarged view of a portion of the self-expanding single-layer valve support 21 of the present application; Figure 5A

[0052] Figure 5C Fig. 12 is a schematic diagram of another structure in which the barbs of the self-expanding single-layer valve support 21 of the present application are replaced by another structure; Figure 5B

[0053] Figure 6 ​​​​​​​Fig. 2 is a schematic view of a skirt frame 212 of the valve support 21 of the present application, which is covered with a film 2123.

[0054] Figure 7 Fig. 4 is a schematic view of the adjustable heart valve replacement system 10 of the present application installed in a heart.

[0055] Reference Signs List:

[0056] 10. An adjustable heart valve replacement system, 21. valve support, 22. anchor support, 211. circumferential main frame, 212. skirt frame, 2121. barb, 2122. delivery link, 2121a. skirt end, 2121b. insertion ring end, 2123. film, 213. leaflet mechanism, 221. constriction ring, 221a. atrium end constriction ring, 221b. ventricle end constriction ring, 2211. clamping head, 2212. clamping ring, 222. braided wire frame, 223. braided mesh. DETAILED DESCRIPTION

[0057] The present application is described in more detail by the following specific examples. Other advantages and effects of the present application can be easily understood by those skilled in the art from this disclosure. The present application can also be implemented or applied by other different specific embodiments, and various modifications or changes can be made to the details in this specification based on different views and applications without departing from the spirit of the present application.

[0058] It should be noted that the following embodiments and features in the embodiments can be combined with each other without conflict.

[0059] In the description of the present application, it should be noted that for orientation words, such as the terms "outer side", "middle section", "inner", "outer", etc. indicate the orientation and positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and cannot be understood as indicating or implying that the devices or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and cannot be understood as limiting the specific protection scope of the present application.

[0060] In addition, the terms "first", "second", etc. are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features. Therefore, the features defined with "first", "second" can explicitly or implicitly include one or more of the features, and in the description of the present application, the meaning of "several", "a number of" is two or more, unless otherwise specifically limited.

[0061] In the present application, when describing the anchoring stent or valve stent, "inflow end", "outflow end" as the orientation word, the orientation word is the conventional term in the field of interventional medical devices, wherein "inflow end" means that the blood flows into one end of the interventional medical device first, for example, the upper end in Fig. 1. "Outflow end" means that the blood flows out of one end of the interventional medical device, for example, the lower end in Fig. 1. In the present application, the orientation of "inflow end" is the same as that of "atrial end", for example, the upper end in Fig. 1. The orientation of "outflow end" is the same as that of "ventricular end", for example, the lower end in Fig. 1. Figure 7 Figure 7

[0062] As shown in Figure 1A and Figure 1B , the adjustable heart valve replacement system 10 of the present application comprises a self-expanding single-layer valve stent 21 easy to be pressed and delivered and a self-expanding spherical anchoring stent 22 ensuring the stable posture of the valve stent 21. The self-expanding single-layer valve stent 21 has a circumferential main stent 211 in a shape similar to a straight cylinder and a flared skirt stent 212 integrally formed at the atrial end of the circumferential stent 211. The anchoring stent 22 is detachably abutted against the skirt stent 212. At least one of the two ends of the anchoring stent 22 has a constriction ring 221. Preferably, both ends of the anchoring stent 22 have the constriction ring 221, i.e., the atrial end and the ventricular end have the atrial end constriction ring 221a and the ventricular end constriction ring 221b, respectively, which can adjust the size of the anchoring stent 22. The size of the two ends of the anchoring stent 22 can be better adjusted, and the size control of the anchoring stent 22 is more accurate, such as the anchoring stent with the shape of small upper and large lower, large upper and small lower, small upper and small lower, etc. The constriction ring 221 at the two ends of the anchoring stent 22 of the adjustable heart valve replacement system 10 of the present application can adjust the size of the device according to the size of the heart of different patients. With the tightening and loosening of the constriction ring 221, the size of the spherical anchoring stent 22 can be changed. Therefore, the constriction ring 221 can be adjusted according to the preoperative data, so that the size of the anchoring stent 22 reaches the best. After the anchoring stent 22 is implanted into the human body, the anchoring stent 22 can adapt to different atrial sizes of patients, thereby achieving a better treatment effect.

[0063] As shown in Figure 2 , the anchoring stent 22 is a hollow spherical self-expanding structure. The anchoring stent 22 can self-expand, and then expand and press the skirt stent 212 of the valve stent 21 after being implanted into the human body, so that the valve stent 21 is more closely fitted with the physiological valve annulus, and the sealing property is increased. The rigidity of the spherical anchoring stent 22 is large. After being implanted into the atrium, the rigidity of the spherical anchoring stent 22 after self-expansion can be used to tightly press the skirt stent 212 of the valve stent 21 on the physiological valve annulus on one side of the atrium, so as to ensure the stability of the valve stent 21. That is, the anchoring stent 22 is the main anchoring structure of the valve stent 21.

[0064] ​​Every person's heart is different, and the model of the device cannot be infinitely adapted to the atrial size of any different patient, and only a relatively close or appropriate device specification can be selected for the patient, which will affect the treatment effect of the device on the patient to some extent. In the example, as shown in Figure 3A To adapt to different heart sizes of different patients, at least one end of the two ends of the anchor stent 22 is provided with a constriction ring 221 capable of adjusting the size of the anchor stent 22, and preferably, the atrial end and the ventricular end are respectively provided with an atrial end constriction ring 221a and a ventricular end constriction ring 221b capable of adjusting the size of the anchor stent 22. The constriction ring 221 can adjust the size of the anchor stent 22 according to different heart sizes. With the tightening and loosening of the constriction ring 221, the size of the anchor stent 22 changes, and then according to the preoperative data, the constriction ring 221 can be adjusted to make the size of the anchor stent 22 optimal, so that the anchor stent 22 can adapt to the different atrial sizes of the patient after being implanted in the human body, thereby achieving a better treatment effect.

[0065] The constriction ring can be any kind of ring that can be enlarged or reduced, and any ring that can be controlled to any desired size is feasible. In an example, as shown in Figure 3B and Figure 3C The constriction ring 221 is an anchoring structure of a clamping head 2211 and a clamping ring 2212. Specifically, as shown in Figure 3D The structure of the constriction ring 221 is designed as follows, that is, the two ends of the constriction ring 221 are respectively provided with a clamping head 2211 and a clamping ring 2212, specifically, one end of the atrial end constriction ring 221a and the ventricular end constriction ring 221b is respectively provided with a plurality of clamping heads 2211 arranged at intervals, and the other end of the atrial end constriction ring 221a and the ventricular end constriction ring 221b is respectively provided with a plurality of clamping rings 2212 arranged at intervals, wherein the clamping head 2211 at one end can be clamped in different clamping rings 2212 to form different sizes of the constriction ring to control the size of the anchor stent 22, so that the size of the anchor stent 22 can be adjusted according to different patients' hearts. In another example, the constriction ring 221 can be a simple constriction ring composed of a suture or a nickel-titanium wire, and the length of the constriction ring can be adjusted by tightening or loosening the ring, so that the two ends of the anchor stent 22 can be contracted or expanded, thereby adjusting the size of the anchor stent 22 according to the heart size of different patients.

[0066] Continuing as shown in 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-shaped woven mesh 223, and the plurality of woven meshes 223 together form a woven wire rack 222 on the peripheral surface of the anchoring stent 22. Of course, the woven meshes 223 can also be of other shapes. The size of each woven mesh 223 can be the same or different, depending on the natural shape of the woven mesh. The woven mesh 223 is surrounded by a plurality of woven wires, and the end of the woven wire rack 222 is connected to a constriction ring 221, i.e. the end of the woven wire rack 222 is formed by the woven wires winding back and forth on the atrial end constriction ring 221a and the ventricular end constriction ring 221b, and the woven wire rack 222 is a spherical structure with a plurality of adjacent rhombus-shaped woven meshes 223. The woven wire here can be a memory metal material, i.e. the woven wire rack 222 of the anchoring stent 22 is woven with memory metal wires, which allows the anchoring stent 22 to be released arbitrarily and does not block the flow of blood in the atrium. The two ends of the woven wire rack 222 are connected to the atrial end constriction ring 221a and the ventricular end constriction ring 221b respectively, so that the middle part of the atrial end constriction ring 221a and the ventricular end constriction ring 221b respectively forms a mutually symmetrical annular opening in communication with the inside of the woven wire rack 222 and located on the same axis. That is, during the weaving of the woven wire rack 222, a ring opening is left at the atrial end and the ventricular end respectively, so that the atrial end and the ventricular end of the anchoring stent 22 form symmetrical ring openings that facilitate blood flow.

[0067] In one example, the anchoring stent 22 is a single-layer structure, and the woven wire rack 222 is woven with memory metal wires, i.e. the memory metal wires are wound back and forth on the atrial end constriction ring 221a and the ventricular end constriction ring 221b to form a spherical woven wire rack 222 composed of a plurality of woven meshes 223. For example, the memory metal wire is a nickel-titanium alloy wire, which allows the anchoring stent 22 to be released arbitrarily, i.e. does not block the flow of blood in the atrium, such as the blood flowing through the left atrium. In this example, the diameter of the nickel-titanium alloy wire can be 0.1-1mm, preferably the diameter of the nickel-titanium alloy wire is 0.1-0.13mm. Such design ensures that the anchoring stent 22 has supporting force, and the relatively thin nickel-titanium alloy wire reduces its impact on blood flow, allowing blood to flow 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, which is illustrated as a double-layer structure in this example. The braided wire frame 222 is woven by memory metal wires, and the double-layer structure formed by the back-and-forth winding of the memory metal wires on the atrial end bunching ring 221a and the ventricular end bunching ring 221b is divided into an outer layer grid and an inner layer grid, i.e., the braided wire frame 222 comprises the outer layer grid and the inner layer grid, and the outer layer grid and the inner layer grid are respectively composed of a plurality of braided grids 223. In this example, the grids of the outer layer grid and the inner layer grid are arranged in a staggered manner, and the grid density of the inner layer grid is smaller than that of the outer layer grid. In some examples, the memory metal wires are made of nickel-titanium wires, and the diameter of the memory metal wires of the inner layer grid is larger than that of the memory metal wires of the outer layer grid. Preferably, the diameter of the memory metal wires of the inner layer grid is 0.3-1 mm, and the diameter of the memory metal wires of the outer layer grid is 0.1-0.5 mm. Generally, the diameter of the memory metal wires of the inner layer grid is larger than that of the memory metal wires of the outer layer grid, because the thicker inner layer grid can provide greater radial support force with smaller grid density (the number of grids per unit area), thereby reducing the impact on blood flow.

[0069] In yet another example, the memory metal wires of the braided grid 223 of the anchoring stent 22 are provided with winding lines to promote the endothelialization of the anchoring stent 22 with the atrium. The winding lines can be one or more of PTFE, PET, TPU, and ultra-high molecular weight polyethylene.

[0070] In yet another example, when controlling the release direction of the anchoring stent 22, a covering film 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 covering film cannot affect the blood flow into the valve stent 21. Of course, it is not necessary to add a covering film.

[0071] As Figure 4AAs shown, the valve stent 21 comprises a circumferential main frame 211 and a skirt frame 212 integrally connected from the ventricular end to the atrial end. The circumferential main frame 211 of the valve stent 21 is a straight cylinder-like stent composed of a plurality of prismatic meshes in the circumferential direction, which is a stent structure for fixing the artificial valve leaflets. In this example, each prismatic mesh of the circumferential main frame 211 has an inflow end, an outflow end, and two side ends, and the side ends of each prismatic mesh in the circumferential direction are integrally connected with the side ends of adjacent prismatic meshes, thereby forming the circumferential main frame 211. The side ends of the upper prismatic meshes of the circumferential main frame 211 also have a function of connecting with the valve leaflet mechanism 213. The skirt frame 212 of the valve stent 21 is a flared skirt-like stent composed of a plurality of prismatic meshes in the circumferential direction. In this example, each prismatic mesh of the skirt frame 212 also has an inflow end, an outflow end, and two side ends. The inflow end of each prismatic mesh of the skirt frame 212 forms an outward expansion structure relative to the outflow end. The side ends of each prismatic mesh in the circumferential direction of the skirt frame 212 are integrally connected with the side ends of adjacent prismatic meshes, thereby forming the skirt frame 212. At the same time, the outflow end of the prismatic mesh of the skirt frame 212 is integrally connected with the inflow end of the corresponding prismatic mesh of the circumferential main frame 211, so that the outflow end of the skirt frame 212 is arranged on the inflow end of the circumferential frame. Therefore, the entire valve stent 21 is an integrally formed structure. The number of prismatic meshes in the skirt frame 212 can be an integer multiple of the number of prismatic meshes in the circumferential main frame 211, and the specific number is a routine design in the art without creative labor. For example, in this example, the number of prismatic meshes in the skirt frame 212 is equal to the number of prismatic meshes in the circumferential main frame 211. After the valve stent 21 of this example is implanted in the heart, the skirt frame 212 will be in close contact with the physiological annulus position on the atrial side. The valve stent 21 is a single-layer self-expanding stent, which is beneficial for compression and delivery, and does not rely on the circumferential main frame 211 to seal with the native valve leaflets, so it does not need to capture the native valve leaflets, thereby reducing the difficulty of implanting the valve stent 21. Since the valve stent 21 does not need the physiological annulus to provide radial support force, i.e., does not need to capture the native valve leaflets or rely on the native valve leaflets for sealing, a double-layer structure is not needed. 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 with the artificial valve leaflets, so the outer layer inevitably dilates the native valve leaflets or annulus. Therefore, in this application, the valve stent 21 is preferably a self-expanding single-layer stent, and the valve stent 21 of this example does not constrain the contraction and expansion movement of the native annulus, and does not limit the annulus movement.

[0072] In this example, as shown in FIG. 1, the valve stent 21 is a single-layer self-expanding stent, which is beneficial for compression and delivery, and does not rely on the circumferential main frame 211 to seal with the native valve leaflets, so it does not need to capture the native valve leaflets, thereby reducing the difficulty of implanting the valve stent 21. Since the valve stent 21 does not need the physiological annulus to provide radial support force, i.e., does not need to capture the native valve leaflets or rely on the native valve leaflets for sealing, a double-layer structure is not needed. 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 with the artificial valve leaflets, so the outer layer inevitably dilates the native valve leaflets or annulus. Therefore, in this application, the valve stent 21 is preferably a self-expanding single-layer stent, and the valve stent 21 of this example does not constrain the contraction and expansion movement of the native annulus, and does not limit the annulus movement. Figure 4BAs shown, the inner side of the valve support 21 is used to accommodate and connect the valve leaflet mechanism 213, which has a plurality of artificial valve leaflets connected to the inner side of the circumferential main frame 211 of the valve support 21, preferably arranged on the main rods of the side ends of the partial prismatic grid of the circumferential main frame 211, i.e. the connecting part of the adjacent two prismatic grids.

[0073] In another example, as shown in Figure 5A As shown, the skirt frame 212 of the valve support 21 has a plurality of outwardly expanded and spaced barbs 2121, which are used to pierce into the physiological valve annulus position. The barbs 2121 are used to fix the valve support 21 and ensure that the valve support remains stable after being implanted into the human heart. Of course, the barbs 2121 on the skirt frame 212 are not necessary structures in the case of anchoring stability of the anchoring support 22. The barbs 2121 on the skirt frame 212 make the valve support 21 more stable after being implanted into the heart.

[0074] In the present example, as shown in Figure 5B As shown, the barbs 2121 have skirt connecting ends 2121a and ring inserting ends 2121b, the skirt connecting ends 2121a are connected to the skirt frame 212, i.e. the skirt connecting ends 2121a of the barbs 2121 are integrally and spacedly connected to the skirt frame 212 at the junctions of the adjacent two prismatic grids, i.e. the connecting part of the side ends of the adjacent two prismatic grids of the skirt frame 212, and the ring inserting ends 2121b extend outwardly from the outer surface of the skirt frame 212, the skirt frame 212 is an outwardly expanded structure, and the barbs 2121 are further outwardly expanded relative to the skirt frame 212. The outward expansion of the ring inserting ends 2121b extending outwardly from the outer surface of the skirt frame 212 facilitates the insertion of the barbs 2121 into the physiological valve annulus. In another example, as shown in Figure 5C As shown, after the barbs 2121 are outwardly expanded to extend outwardly from the outer surface of the skirt frame 212, the barbs 2121 are further outwardly turned so that the ring inserting ends 2121b point to the ventricular end, which facilitates the direct insertion of the barbs 2121 into the physiological valve annulus located on the atrial side, and can increase the stability of the valve support 21 after being implanted. In the present example, the number of barbs can refer to the number of barbs on the valve support in the prior art, or can be reasonably set according to the stability requirements of the insertion into the physiological valve annulus, and the skilled person in the art does not need to make creative efforts for this.

[0075] In another example, the skirt frame 212 of the valve support 21 has a plurality of spaced transport connecting rods 2122, which are used to be connected to the heart valve replacement system transporter to increase the stability of the valve support 21 during the release process. Of course, the transport connecting rods 2122 are also not necessary structures. In the case of not arranging the transport connecting rods 2122, a plurality of pull wires can be directly connected to the skirt frame 212 to increase the stability of the valve support 21 during the release process, prevent the valve support 21 from bouncing out of the transporter catheter in the final stage of release, and cause the implantation posture of the valve support 21 to be skewed.Figure 5A As shown, one end of several conveying links 2122 is spaced apart on the skirt frame 212, meaning that one end of each conveying link 2122 is integrally formed and spaced apart at the junction of two adjacent rhomboid meshes of the skirt frame 212 without barbs 2121, i.e., at the side connection point. In other words, only one of barbs 2121 and conveying links 2122 is connected at the junction between two adjacent rhomboid meshes. The other ends of the several conveying links 2122 are close to each other, meaning that the other ends of the conveying links 2122 are concentrated at the internal center of the valve stent 21. At the same time, the other ends of the several conveying links 2122 each have a pull wire hole 2122a for the pull wire to pass through, thereby further increasing the stability of the valve stent 21 release and preventing the several conveying links 2122 from popping out and deforming. In this example, the number of conveying links 2122 can be reasonably set according to the stability requirements during the conveying process, such as 3 links, or other numbers, which does not require creative effort from those skilled in the art.

[0076] like Figure 6 As shown, in this example, the inner side of the skirt frame 212 has a membrane 2123, which can improve the sealing performance. This is because the artificial leaflet is directly connected to the rhomboid mesh connecting rod of the valve stent 21. The valve stent is prone to paravalvular leakage (when the leaflet mechanism 213 is closed, blood flows back to the inlet end through the outer side of the valve stent 21). Therefore, the artificial leaflet is connected to the valve stent 21 through the membrane 2123. Here, the inlet end of the membrane extends at least to the middle of the skirt frame 212 of the valve stent 21. Preferably, the inlet end of the membrane 2123 extends to the inlet end of the skirt frame 212 of the valve stent 21. Furthermore, the inlet end of the membrane 2123 extends beyond the inlet end of the skirt frame 212 by 1 mm to 5 mm, and the excess membrane 2123 is folded to the outer side of the valve stent 21. The outlet end of the membrane 2123 is connected to the edge of the inlet end of the artificial leaflet. In some embodiments, the diaphragm 2123 located inside the valve stent 21 extends to the outflow end of the circumferential main frame 211, so that the valve stent 21 can be completely covered. In another example, the skirt frame 212 is provided with diaphragms 2123 on both the inner and outer sides, and a TPU diaphragm is provided on the inner side of the diaphragm 2123 to prevent blood from seeping through the gaps in the diaphragm 2123.

[0077] like Figure 7As shown, the valve stent 21 and the anchoring stent 22 can be delivered separately, and the diameter of the compressed stent is small, so that the stent can be delivered and implanted through the femoral artery and other ways. The two stents are delivered separately and enter the human body in steps, so that the stent can be delivered and implanted through a thinner catheter, and the expansion of the blood vessel is reduced. The anchoring stent 22 is coaxially pressed against the skirt frame 2121 of the valve stent 21, that is, the mutually symmetrical ring openings of the anchoring stent 21 located on the same axis are coaxially arranged with the central axis of the valve stent 21, so as to facilitate the blood circulation. The rigidity of the anchoring stent 22 after self-expansion can always press the skirt frame 212 of the valve stent 21 against the physiological valve ring, so that the skirt frame 212 of the valve stent 21 is more closely attached to the physiological valve ring on the atrial side, the sealing effect is increased, and the stability of the valve stent 21 is ensured.

[0078] The above detailed description of the present application is made in combination with the embodiments of the drawings, and those of ordinary skill in the art can make various changes to the present application according to the above description. Therefore, some details in the embodiments should not constitute a limitation on the present application, and the scope of protection of the present application will be defined by the appended claims.

Claims

1. An adjustable heart valve replacement system, characterized by The adjustable heart valve replacement system comprises: a self-expanding single-layer valve stent with a circumferential main frame and a skirt frame integrally formed at an atrial end of the circumferential main frame, an inflow end of the skirt frame forming an outward expansion structure relative to an outflow end; a self-expanding spherical anchoring stent abutting against the skirt frame, at least one of an atrial end and a ventricular end of the anchoring stent having a size-adjustable constriction ring, one end of the constriction ring having a plurality of interval arranged clamping heads on an outer surface, the other end of the constriction ring having a plurality of interval arranged clamping rings on an inner surface, the clamping heads being clamped in the different clamping rings to form anchoring stents of different sizes, the anchoring stent having a braided wire frame on a circumferential surface, the braided wire frame being connected with the constriction ring, and the braided wire frame being formed by the braided wire being wound back and forth on the constriction ring.

2. The adjustable heart valve replacement system of claim 1, wherein The atrial end and the ventricular end of the anchoring stent respectively have 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, wherein the middle part of the atrial end constriction ring and the middle part of the ventricular end constriction ring respectively form mutually symmetrical ring openings in communication with the inside of the braided wire frame and located on the same axis line, and the anchoring stent is coaxially abutted against the skirt frame.

4. The adjustable heart valve replacement system of claim 1, wherein The braided wire frame is wound back and forth on the constriction ring to form an outer layer mesh and an inner layer mesh, and the mesh of the outer layer mesh is arranged in a staggered manner with the mesh of the inner layer mesh.

5. The adjustable heart valve replacement system of claim 4, wherein The mesh density of the inner layer mesh is smaller than the mesh density of the outer layer mesh, and the wire diameter of the inner layer mesh is larger than the wire diameter of the outer layer mesh.

6. The adjustable heart valve replacement system of claim 1, wherein The skirt frame has a plurality of interval arranged barbs outward expanded.

7. The adjustable heart valve replacement system of claim 6, wherein The barb has a skirt connecting end and a ring inserting end, the skirt connecting end is connected with the skirt frame, and the ring inserting end points to the ventricular end.

8. The adjustable heart valve replacement system of claim 6 or 7, characterized in that The skirt connecting end of the barb is integrally connected at the junction of adjacent two prismatic mesh grids of the skirt frame.

9. The adjustable heart valve replacement system of claim 1, wherein The valve stent has a plurality of delivery connecting rods, one end of each of the delivery connecting rods is interval arranged on the skirt frame, and the other end of each of the delivery connecting rods is close to each other.

10. The adjustable heart valve replacement system of claim 9, wherein The other end of each of the delivery connecting rods has a pull wire hole.

11. The adjustable heart valve replacement system of any of claims 9-10, wherein The one end of the delivery connecting rod is integrally connected at the junction of adjacent two prismatic mesh grids of the skirt frame.

12. The adjustable heart valve replacement system of claim 1, wherein The valve stent has a covering arranged on the inside, and the valve stent is connected with a valve leaflet mechanism through the covering.

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