Split aortic regurgitation valve stent and artificial valve

Abstract

The application provides a split aortic regurgitation valve stent and artificial valve, the valve stent comprises a stent body and a positioning member, the positioning member is sleeved on the outer periphery of the stent body, one end of the positioning member is movably connected to one end of the stent body through a soft connection structure; the stent body is divided into an inflow end and an outflow end along the axial direction; the positioning member has a plurality of positioning rods connected in sequence, the middle part of the positioning rod is formed with a bent positioning foot towards the inflow end, the two ends of the positioning rod are connected to the outflow end through the soft connection structure and towards the outflow end, a threaded sleeve is arranged on the bent positioning foot, and the threaded sleeve is used for being connected with a traction thread in a threaded mode to control the opening angle of the positioning member in the implantation process through the traction thread. The opening angle of the positioning member is controllable, and the risk of sinus injury is relatively low.

Description

Technical Field

[0001] This invention relates to the field of implantable medical device technology, and more particularly to a split aortic regurgitation valve stent and an artificial valve. Background Technology

[0002] Aortic regurgitation is a common valvular heart disease characterized by the inability of the aortic valve to close completely during diastole, causing blood to flow backward from the aortic arteries into the left ventricle. This abnormal blood flow increases the volume overload of the left ventricle, and long-term progression can lead to left ventricular enlargement, decreased cardiac function, and even heart failure.

[0003] Currently, treatment options for aortic regurgitation mainly include medication, surgical aortic valve replacement, and transcatheter aortic valve replacement (TAVCR). TAVCR, a minimally invasive interventional technique, involves delivering a folded artificial valve to the aortic valve region via a catheter and fixing it in place using balloon dilation or self-expansion mechanisms. While this technique has demonstrated certain advantages in clinical application, it still faces risks such as difficulties in positioning and fixation, paravalvular leakage, and coronary artery obstruction.

[0004] Currently, aortic regurgitation treatment stents on the market can be mainly divided into two structural types. One is the integrated stent structure, represented by Jenavallve. This design has the following potential limitations: 1. The bottom end of the positioning element is often relatively sharp due to the overall cutting process, which may increase the risk of damage to the aortic sinus; 2. The hollowed-out area at the bottom of the positioning element is prone to shifting under the valve when implanted at a slightly deeper position, forming a paravalvular leakage channel; 3. After the original valve leaflet is clamped, it is easy to shift towards the artificial valve leaflet area, causing structural interference and affecting long-term safety; 4. The height under the valve annulus is usually large, which may increase the risk of conduction block.

[0005] Another type is the split structure, taking the J-valve as an example. Its potential drawbacks mainly include: 1. The opening angle of the positioning component is uncontrollable, which makes implantation particularly difficult for patients with transverse heart disease; 2. The flexible connection between the positioning component and the stent body may lead to misalignment between the artificial leaflet and the original leaflet, resulting in uncertainty in long-term hemodynamic performance; 3. The components are compressed separately and then sent into the delivery system, resulting in a large overall compressed length, which may encounter obstacles when passing through the small aortic arch.

[0006] Therefore, developing a valve stent with controllable positioning angle, low risk of sinus injury, low incidence of paravalvular leak, avoidance of artificial valve leaflet interference, and excellent long-term hemodynamic performance remains an important research direction worthy of attention. Summary of the Invention

[0007] The purpose of this invention is to provide a split-type aortic regurgitation valve stent and artificial valve, which solves the main problems of current aortic regurgitation treatment stents.

[0008] The above-mentioned technical objectives of the present invention are mainly achieved through the following technical solutions.

[0009] On one hand, the present invention provides a split aortic regurgitation valve stent, which includes a stent body and a positioning element. The positioning element is sleeved on the outer periphery of the stent body, and one end of the positioning element is movably connected to one end of the stent body through a flexible connection structure.

[0010] The support body is divided into an inflow end and an outflow end along the axial direction;

[0011] The positioning element has multiple positioning rods connected end to end. The middle of each positioning rod has a bent positioning foot facing the inflow end. Both ends of the positioning rod face the outflow end and are connected to the outflow end through the flexible connection structure. The bent positioning foot is provided with a threaded sleeve, which is used to be threadedly connected to the traction line to control the angle of the positioning element during the implantation process through the traction line.

[0012] In a preferred embodiment of the present invention, the threaded sleeve is fixedly installed on the outer wall surface of the bent positioning foot facing the outlet end and extends toward the outlet end.

[0013] In a preferred embodiment of the present invention, the bent positioning foot is provided with a marking connecting rod extending toward the outlet end, the marking connecting rod is provided with a radiopaque marker, and the threaded sleeve is fixedly installed on the marking connecting rod.

[0014] In a preferred embodiment of the present invention, the marking connecting rod has a wavy sidewall surface, and one end of the threaded sleeve is provided with an elastic mounting hole. Under the action of pressing, the marking connecting rod can be inserted into the elastic mounting hole to achieve locking.

[0015] In a preferred embodiment of the present invention, the soft connection structure is a suture binding structure.

[0016] In a preferred embodiment of the present invention, the positioning rods are all U-shaped rods, and the bottom of the U-shaped rods has an arc-shaped bottom that serves as the bent positioning foot.

[0017] In a preferred embodiment of the present invention, the positioning rods are all V-shaped rods, and the bottom of the V-shaped rods has a U-shaped arc bottom that serves as the bent positioning foot.

[0018] In a preferred embodiment of the present invention, the positioning member has three positioning rods, the ends of two adjacent positioning rods are fixedly connected to form a connecting part, and the three connecting parts are movably connected to the outflow end of the support body through the flexible connection structure.

[0019] In a preferred embodiment of the present invention, the outflow end of the support body is provided with a V-shaped cut extending toward the inflow end, and the position of the V-shaped cut corresponds to the V-shaped rod or the U-shaped rod.

[0020] On the other hand, the present invention also provides an artificial valve, comprising:

[0021] The split-type aortic regurgitation valve stent described above;

[0022] An artificial leaflet is disposed inside the stent body of the split-type aortic regurgitation valve stent.

[0023] Compared with the prior art, the technical solution of the present invention has the following characteristics and advantages:

[0024] 1. The split-type aortic regurgitation valve stent of the present invention, by setting a threaded sleeve on the positioning component for threaded connection with the traction line, makes the original opening angle of the positioning component large and controls its opening angle during implantation, making it easier to enter the sinus during surgery, and patients with transverse heart can benefit from it.

[0025] 2. The split-type aortic regurgitation valve stent of the present invention has a split structure that allows the positioning component and the stent body to be cut and formed without spatial restrictions. The arc edge at the bottom of the positioning component is smoother and wider, which can prevent it from puncturing the aortic sinus.

[0026] 3. The split-type aortic regurgitation valve stent of this invention has a positioning element bound to the stent body by sutures, which is both a soft connection and a hard connection. The soft connection lies in the fact that the positioning element is connected by sutures, which can buffer the stress on the positioning element and release its degree of freedom in the angular direction to a certain extent, greatly reducing the risk of fatigue fracture at the connection point between the positioning element and the stent body. The hard connection lies in the fact that the binding with sutures can achieve alignment of the native and artificial valve leaflets at the junction.

[0027] 4. The split-type aortic regurgitation valve stent of this invention features a V-shaped incision structure on the stent body that effectively prevents stent blockage of the coronary arteries, providing sufficient access for coronary re-intervention. Furthermore, the bottom of the V-shaped incision has a certain height difference relative to the bottom of the positioning element. After the positioning element clamps the native leaflet, the V-shaped incision provides sufficient barrier function against the native leaflet, reducing interference between the native and artificial leaflets and providing long-term durability. In addition, the height difference between the V-shaped incision and the bottom of the positioning element can further reduce the risk of paravalvular leakage. Attached Figure Description

[0028] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort. In the drawings:

[0029] The accompanying drawings described herein are for illustrative purposes only and are not intended to limit the scope of the invention in any way. Furthermore, the shapes and proportions of the components in the drawings are merely illustrative to aid in understanding the invention and do not specifically limit the shapes and proportions of the components. Those skilled in the art, guided by the teachings of this invention, can select various possible shapes and proportions to implement the invention according to specific circumstances.

[0030] Figure 1 This is a schematic diagram of the structure of the split-type aortic regurgitation valve stent described in this invention;

[0031] Figure 2 This is a schematic diagram of the structure of the support body described in this invention;

[0032] Figure 3 This is a structural schematic diagram of the support body described in this invention from another perspective;

[0033] Figure 4 This is a schematic diagram of the positioning component described in this invention;

[0034] Figure 5 This is a partial structural diagram of the outlet end of the support body described in this invention;

[0035] Figure 6 This is a schematic diagram of the structure of the support body after loading at the outlet end;

[0036] Figure 7 This is a top view of the split-type aortic regurgitation valve stent described in this invention.

[0037] Figure 8 This is a partial structural diagram of the outlet end of the support body described in this invention;

[0038] Figure 9 This is another partial structural diagram of the outlet end of the support body described in this invention.

[0039] Explanation of reference numerals in the attached figures:

[0040] 10. Support body; 11. Inlet end; 12. Outlet end; 13. First connecting part; 14. V-shaped cut; 15. Vertical rod; 16. Loading hole;

[0041] 20. Positioning component; 21. Positioning rod; 22. Bending positioning foot; 23. Marking connecting rod; 25. Second connecting part;

[0042] 30. Connector. Detailed Implementation

[0043] To enable those skilled in the art to better understand the technical solutions of this invention, the technical solutions of the embodiments of this invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this invention, and not all embodiments. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of this invention.

[0044] It should be noted that when an element is referred to as being "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only embodiments.

[0045] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the specification of this invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0046] Implementation Method 1:

[0047] This invention provides a split-type aortic regurgitation valve stent, such as... Figures 1 to 4As shown, it includes a stent body 10 and a positioning element 20. The positioning element 20 is sleeved on the outer periphery of the stent body 10, and one end of the positioning element 20 is movably connected to one end of the stent body 10 through a flexible connection structure. The stent body 10 is divided into an inflow end 11 and an outflow end 12 along the axial direction. The positioning element 20 has a plurality of positioning rods 21 connected end to end in sequence. A bent positioning foot 22 is formed in the middle of the positioning rod 21 and faces the inflow end 11. Both ends of the positioning rod 21 face the outflow end 12 and are connected to the outflow end 12 through a flexible connection structure. A threaded sleeve is provided on the bent positioning foot 22. The threaded sleeve is used to be threadedly connected to the traction line to control the angle of the positioning element 20 during the implantation process through the traction line.

[0048] The split-type aortic regurgitation valve stent of the present invention has a split structure in which the stent body 10 and the positioning element 20 are slidably connected by a soft connection structure. On this basis, the threaded sleeve on the positioning element 20 is threadedly connected to the traction line, so that the opening angle of the positioning element 20 can be controlled by the traction line during the valve stent implantation process, ensuring that the positioning element 20 can be smoothly inserted into the aortic sinus before the stent body 10 is released, which is especially suitable for patients with transverse heart.

[0049] The following will describe the specific structure of each part of the split aortic regurgitation valve stent described in this invention, as well as the position and connection relationship between each part.

[0050] The split-type aortic regurgitation valve stent has a stent body 10, such as Figures 1 to 3 As shown, the stent body 10 serves as the main structure of the valve stent and is cut from a specific metal material.

[0051] The stent body 10 is a cylindrical structure with openings at both ends. Multiple regularly arranged hollow openings are cut out on its side walls. In this embodiment, the hollow openings are diamond-shaped. The hollow openings allow the stent body 10 to be compressed and expanded, thus facilitating its implantation.

[0052] Along the axial direction of the stent body 10, the upper and lower ends of the stent body 10 are the outflow end 12 and the inflow end 11, respectively. After implantation, blood flows into the valve stent from the inflow end 11, passes through the artificial valve, and then flows out from the outflow end 12.

[0053] A first connecting portion 13 is provided at the outlet end 12 of the support body 10, and the first connecting portion 13 is used to connect with the positioning member 20. In this embodiment, three first connecting portions 13 are provided at intervals along the circumferential direction at the outlet end 12 of the support body 10, and the three first connecting portions 13 are evenly arranged circumferentially. In this embodiment, the first connecting portion 13 includes an extension rod extending upward from the outlet end 12 of the support body 10, and a first connecting hole is provided on the extension rod. The extension rod is integrally formed during the cutting and forming process of the support body 10.

[0054] Furthermore, such as Figure 3 As shown, the outlet end 12 of the support body 10 has a V-shaped cut 14 extending toward the inlet end 11. The V-shaped cut 14 is integrally formed during the cutting and forming process of the support body 10. In this embodiment, the outlet end 12 of the support body 10 has three V-shaped cuts 14 spaced apart in the circumferential direction, and the three V-shaped cuts 14 are evenly arranged in the circumferential direction.

[0055] Furthermore, such as Figure 3 , Figure 5 and Figure 6 As shown, the outlet end 12 of the bracket body 10 has an upwardly extending vertical rod 15, a portion of which extends further upward and forms a loading hole 16. The loading hole 16 is used to load the bracket body 10 in the folded state into and fix it in the connector 30.

[0056] In this embodiment, as Figure 3 As shown, the outlet end 12 of the support body 10 is evenly provided with three vertical rods 15 with loading holes 16 around its circumference, and a vertical rod 15 without loading holes 16 is provided on one side of the vertical rod 15 with loading holes 16; the extension rod in the first connecting part 13 is located between the vertical rod 15 with loading holes 16 and the vertical rod 15 without loading holes 16. The vertical rods 15 (including those with loading holes 16 and those without loading holes 16) are all integrally formed during the cutting and forming process of the support body 10.

[0057] The vertical rod 15 of the outlet end 12 has a certain length in the axial direction of the support body 10, so all the vertical rods 15 can be retracted into the connector 30, so that the head of the support body 10 will not open when it is loaded and released, reducing the risk of premature release of the support body 10.

[0058] Meanwhile, along the axial direction of the support body 10, the head of the vertical rod 15 without the loading hole 16 is located between the first connecting hole and the loading hole 16. During loading, the vertical rod 15 with the loading hole 16 can be loaded first, and then the vertical rod 15 without the loading hole 16 can be loaded, thus making the loading process of the support body 10 more convenient; after the vertical rod 15 is loaded in place, as... Figure 6 As shown, the first connecting hole on the bracket body 10 (corresponding to the second connecting part 25 on the positioning member 20) is installed outside the connector 30, so the head of the positioning member 20 connected thereto will not be pressed, ensuring that the opening angle of the positioning member 20 is not limited by the connector 30.

[0059] The split-type aortic regurgitation valve stent also has a positioning element 20, such as... Figure 1 and Figure 4As shown, the positioning component 20 serves as an auxiliary positioning, installation, and fixation structure for the valve stent, and it is also cut from a specific metal material.

[0060] The positioning member 20 is sleeved on the outer periphery of the support body 10, and has a plurality of positioning rods 21 connected end to end in the circumferential direction. In this embodiment, the positioning member 20 has three positioning rods 21. The middle part of the positioning rod 21 is formed with a bent positioning foot 22 facing the inflow end 11, while the two ends of the positioning rod 21 are facing the outflow end 12 and connected to the support body 10.

[0061] like Figure 7 As shown, the positioning element 20 has a certain initial opening angle, and the bottom of the positioning element 20 and the support body 10 are a certain distance d in the radial direction, thereby forming a certain clamping space, so that the original leaflet can be smoothly clamped between the positioning element 20 and the support body 10, ensuring that the positioning element 20 can easily enter the sinus during loading; preferably, the distance d is less than 5mm.

[0062] In an optional embodiment, all three positioning rods 21 are U-shaped rods, with the bottom of the U-shaped rod having an arc-shaped base that serves as a bent positioning foot 22.

[0063] In another alternative embodiment, the positioning rods 21 are all V-shaped rods, and the bottom of the V-shaped rods has a U-shaped arc bottom that serves as a bent positioning foot 22.

[0064] Whether it is a U-shaped bar or a V-shaped bar, the bent positioning foot 22 at the bottom has a rounded arc structure, thereby avoiding damage to the patient's aortic sinus.

[0065] The bent positioning foot 22 of the positioning member 20 has a certain width, preferably greater than 5mm. The bent positioning foot 22 has a larger contact area with the aortic sinus, and when subjected to axial impact force, the force transmitted to the sinus floor through the positioning member 20 is more dispersed, which can reduce the risk of puncturing the aortic sinus. Similarly, the bent positioning foot 22 has a larger contact area with the leaflet, which can further limit the circumferential twisting of the stent and increase the anchoring effect of the positioning member 20.

[0066] Furthermore, the ends of two adjacent positioning rods 21 are fixedly connected to form a second connecting part 25, and a second connecting hole is provided on each of the three second connecting parts 25.

[0067] The support body 10 and the positioning element 20 are movably connected by a flexible connection structure. In this embodiment, the flexible connection structure is a suture binding structure, that is, after aligning the first connecting hole on the first connecting part 13 and the second connecting hole on the second connecting part 25, the suture is passed through the two connecting holes and bound.

[0068] The connection between the stent body 10 and the positioning element 20 is achieved by binding the structure with sutures, so that the positioning element 20 and the stent body 10 are not limited by space when being cut and shaped. The arc edge at the bottom of the positioning element 20 is smoother and wider, which can prevent it from puncturing the aortic sinus.

[0069] Better, such as Figure 1 As shown, the V-shaped incisions 14 on the stent body 10 are all located between two adjacent first connecting parts 13, so that after the positioning member 20 is sleeved on the stent body 10, the position of the V-shaped incision 14 corresponds to the V-shaped rod or U-shaped rod. After the valve stent is implanted in place, the artificial valve and the original valve correspond one-to-one in space, achieving boundary alignment.

[0070] Furthermore, the outer wall surface of the bent positioning foot 22 facing the outlet end 12 is provided with a marking connecting rod 23 extending towards the outlet end 12. The marking connecting rod 23 is provided with a radiopaque marker to achieve imaging under the surgical DSA environment and prevent the positioning component 20 from being implanted too deeply during the operation.

[0071] The marking connecting rod 23 has a wavy sidewall, and one end of the threaded sleeve has an elastic mounting hole. Under pressure, the marking connecting rod 23 can be inserted into the elastic mounting hole to achieve locking. The other end of the threaded sleeve can be threadedly connected to a threaded traction wire (metal wire). The delivery system controls the pulling of the metal wire remotely to control the angle of the positioning element 20. After the positioning element 20 is adjusted and positioned during the operation, the metal wire can be rotated to separate the metal wire from the threaded sleeve and remove the metal wire from the body, greatly improving the surgeon's operability during the operation.

[0072] The wire control design of the positioning element 20 allows it to generate a large opening angle (such as 90° or 120°). During the operation, the surgeon can control the opening angle of the positioning element 20 according to the delivery system, which makes it easier to insert the positioning element 20 into the aortic sinus for positioning.

[0073] like Figure 8 As shown, the bottom of the positioning member 20 and the bottom of the support body 10 have a certain ring height L in the axial direction. Preferably, the ring height L is less than 10mm. The setting of the ring height can reduce the risk of the inflow end 11 of the support body 10 touching the His bundle.

[0074] like Figure 9 As shown, the bottom of the V-shaped cut 14 on the stent body 10 is higher than the bottom of the positioning rod 21 inside the positioning member 20. After the stent is installed, it can better fit with the original leaflet, thereby reducing the risk of potential paravalvular leakage. Preferably, the height difference H between the bottom of the V-shaped cut 14 on the stent body 10 and the bottom of the positioning rod 21 inside the positioning member 20 is less than 10mm.

[0075] like Figure 9 As shown, the positioning element 20 is located outside both sides of the V-shaped incision 14, and the positioning rod 21 inside the positioning element 20 is a certain distance away from the side of the V-shaped incision 14. While further restricting the movement space of the original leaflet, it increases the contact area with the original leaflet, thereby increasing the friction between the support and the original leaflet, improving the anchoring effect of the support, and effectively preventing the original leaflet from interfering with the artificial leaflet. Preferably, the distance I between the positioning rod 21 inside the positioning element 20 and the side of the V-shaped incision 14 is greater than 5mm.

[0076] Implementation Method Two:

[0077] The present invention also provides an artificial valve, comprising: a split aortic regurgitation valve stent as described in Embodiment 1; and an artificial leaflet disposed inside the stent body 10 of the split aortic regurgitation valve stent.

[0078] The specific structure and technical effects of the artificial valve split aortic regurgitation valve stent have been described in detail in Implementation Method 1, and will not be repeated here.

[0079] The specific embodiments described above further illustrate the purpose, technical solution, and beneficial effects of the present invention. It should be understood that the above descriptions are merely specific embodiments of the present invention and are not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A split aortic regurgitation valve stent, characterized in that, It includes a support body (10) and a positioning element (20). The positioning element (20) is sleeved on the outer periphery of the support body (10), and one end of the positioning element (20) is movably connected to one end of the support body (10) through a flexible connection structure. The support body (10) is divided into an inflow end (11) and an outflow end (12) along the axial direction. The positioning element (20) has a plurality of positioning rods (21) connected end to end. The middle part of the positioning rod (21) forms a bent positioning foot (22) facing the inflow end (11). The two ends of the positioning rod (21) face the outflow end (12) and are connected to the outflow end (12) through the flexible connection structure. The bent positioning foot (22) is provided with a threaded sleeve. The threaded sleeve is used to be threadedly connected to the traction line to control the angle of the positioning element (20) during the implantation process through the traction line. The bent positioning foot (22) is provided with a marking connecting rod (23) extending toward the outlet end (12), the marking connecting rod (23) is provided with a non-transparent marking object, and the threaded sleeve is fixedly installed on the marking connecting rod (23).

2. The split-type aortic regurgitation valve stent according to claim 1, characterized in that, The threaded sleeve is fixedly installed on the outer wall surface of the bent positioning foot (22) facing the outlet end (12) and extends towards the outlet end (12).

3. The split-type aortic regurgitation valve stent according to claim 1, characterized in that, The marking connecting rod (23) has a wavy side wall surface, and one end of the threaded sleeve is provided with an elastic mounting hole. Under the action of pressing, the marking connecting rod (23) can be inserted into the elastic mounting hole to achieve locking.

4. The split-type aortic regurgitation valve stent according to claim 1, characterized in that, The soft connection structure is a suture binding structure.

5. The split-type aortic regurgitation valve stent according to claim 1, characterized in that, The positioning rods (21) are all U-shaped rods, and the bottom of the U-shaped rods has an arc-shaped bottom that serves as the bent positioning foot (22).

6. The split-type aortic regurgitation valve stent according to claim 1, characterized in that, The positioning rods (21) are all V-shaped rods, and the bottom of the V-shaped rods has a U-shaped arc bottom that serves as the bent positioning foot (22).

7. The split-type aortic regurgitation valve stent according to claim 5 or 6, characterized in that, The positioning member (20) has three positioning rods (21), and the ends of two adjacent positioning rods (21) are fixedly connected to form a connecting part. The three connecting parts are movably connected to the outlet end (12) of the support body (10) through the flexible connection structure.

8. The split-type aortic regurgitation valve stent according to claim 5 or 6, characterized in that, The outlet end (12) of the support body (10) is provided with a V-shaped cut (14) extending toward the inlet end (11), and the position of the V-shaped cut (14) corresponds to the V-shaped rod or U-shaped rod.

9. An artificial valve, characterized in that, include: The split-type aortic regurgitation valve stent according to any one of claims 1-8; Artificial leaflet, the artificial leaflet being disposed inside the stent body (10) of the split aortic regurgitation valve stent.

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