Aortic valve stent and aortic valve

Abstract

The invention discloses an aortic valve stent and an aortic valve, which are used for the aortic valve, so that the aortic valve can be suitable for being implanted in an aorta of an elbow structure. An anchoring unit is arranged at the position, close to the inflow end, of the aortic valve stent, the anchoring unit is located on one side of the aortic valve stent, and in the release process of aortic valve implantation, the anchoring unit is fixed to the autologous valve ring through interaction force between the anchoring unit and the autologous valve ring. The movement of the aortic valve stent on the side where the anchoring unit is arranged in the axial direction of the aortic valve is limited. Based on the anchoring function of the anchoring unit in the implanting and releasing process and the function of serving as a self-adjusting reference, the accuracy and reliability of the final implanting state and the implanting position of the aortic valve can be well guaranteed.

Description

Technical Field

[0001] This invention belongs to the field of biomedical technology, specifically relating to an aortic valve stent and an aortic valve. Background Technology

[0002] Aortic valve implantation typically uses the right femoral artery as the primary approach. A delivery system is used to insert the sheath into the aortic root, then along the guidewire to the implantation site. The valve is then slowly released to complete the implantation. In some complex cases, such as transverse hearts or acute-angled aortic arches, where an aortic arch exists between the descending and ascending aortas at an angle, although an adjustable delivery system can deliver the valve across the aortic arch to the implantation site, this curved structure makes it difficult to guarantee the final implantation position of the valve during release, thus affecting the implantation outcome. Summary of the Invention

[0003] The purpose of this invention is to provide an aortic valve stent and an aortic valve to solve the problem of difficulty in ensuring the final implantation position and state of the valve in complex implantation scenarios such as transverse heart and acute-angled aortic arch.

[0004] This invention is achieved through the following technical solution: Aortic valve stents are used for aortic valves to enable implantation of aortic valves in the curved aorta. An anchoring unit is provided on the aortic valve stent near the inflow end. The anchoring unit is located on one side of the aortic valve stent. During the release process of aortic valve implantation, the interaction force between the anchoring unit and the autologous valve annulus restricts the movement of the aortic valve stent along the axial direction of the aortic valve on the side where the anchoring unit is located.

[0005] In some embodiments of the present invention, the anchoring unit is one or more barbs extending outward on the aortic valve stent, which can form an anchoring connection with the autologous valve annulus on that side through the barbs.

[0006] In some embodiments of the present invention, the anchoring unit is a friction part provided on the aortic valve stent. The friction force generated when the friction part contacts the autologous valve annulus restricts the movement of the aortic valve stent along the axial direction of the aortic valve on this side.

[0007] In some embodiments of the present invention, the aortic valve stent includes a main stent and an auxiliary stent covering the outside of the main stent, and the anchoring unit is disposed on the auxiliary stent.

[0008] In some embodiments of the present invention, the anchoring unit is one or more barbs extending outward on the stent, and the aortic valve stent can form an anchoring connection with the autologous valve annulus on this side through the barbs.

[0009] In some embodiments of the present invention, the auxiliary frame is a wave-shaped support structure, and the barbs are formed by bending one or more trough ends of the wave-shaped support outward.

[0010] In some embodiments of the present invention, the anchoring unit is a friction part disposed on the stent, and the friction force generated when the friction part contacts the autologous valve annulus restricts the movement of the aortic valve stent along the axial direction of the aortic valve on this side.

[0011] In some embodiments of the present invention, the ends of the barbs have a forked structure.

[0012] In some embodiments of the present invention, the auxiliary frame has a ring structure.

[0013] In some embodiments of the present invention, the auxiliary frame has a semi-ring structure.

[0014] On the other hand, the present invention also provides an aortic valve, including the aforementioned aortic valve stent.

[0015] In some embodiments of the present invention, when the aortic valve is implanted, the anchoring unit is positioned toward the large-diameter side of the autologous valve annulus, so that when the aortic valve is released, the anchoring unit is anchored to the large-diameter side of the autologous valve annulus, where the large-diameter side is the outward-facing side of the curved tube structure.

[0016] Compared with the prior art, the present invention has the following advantages and beneficial effects: Regarding the issue of valve implantation deviation during valve implantation, research has found that, referring to... Figure 1 and Figure 2 The descending aorta forms a curved tube structure with the ascending aorta as the conduit. The side facing inwards in this curve is the small-diameter side, and the side facing outwards is the large-diameter side. It can be seen that the radius of curvature of the small-diameter side is significantly smaller than that of the large-diameter side. When the valve is released at the implantation site, the inflow end is released first, while the outflow end remains fixedly connected to the sheath of the delivery system. Figure 2 As shown; due to the difference in the radius of curvature between the small-diameter side and the large-diameter side, the deformation amplitude of the valve stent on the small-diameter side is greater than that on the large-diameter side. This results in the valve inflow end being implanted much deeper on the small-diameter side than the valve outflow end on the large-diameter side, causing the end face of the valve inflow end to be perpendicular to the axis of the curved tube structure ( Figure 2 (As shown by the dashed line) is set at an angle, see Figure 2 .

[0017] When the outflow end of the valve is released, the valve will self-adjust at the implantation position due to its own expansion and deformation. However, because the inflow end of the valve is tilted and the self-adjustment action of the valve is uncontrollable, it is difficult to guarantee the final implantation position and the final implantation state of the valve.

[0018] To address the aforementioned problems, this invention incorporates an anchoring unit on the aortic valve stent located near the inflow end. During implantation, the anchoring unit faces the large-diameter side of the curved structure. When the inflow end of the valve is released, the anchoring unit anchors the valve stent between the large-diameter side of the autologous valve annulus and the autologous valve annulus. When the outflow end of the valve is released, the valve self-adjusts at the implantation position due to the expansion and deformation of the valve stent itself. Because of the anchoring and limiting effect of the anchoring unit on that side, the position of the valve stent's inflow end facing the large-diameter side remains unchanged, while the side of the valve's inflow end facing the small-diameter side moves towards the outflow end. This allows the tilted inflow end to be adjusted to a state perpendicular to the axis of the curved structure. Figure 8 As shown. This not only ensures the final implantation state of the valve, but also guarantees the accuracy of the final implantation position of the valve due to the positioning role played by the anchoring unit during valve implantation and self-adjustment.

[0019] The anchoring unit in this invention can be barbed, which anchors the aortic valve on the autologous valve annulus. Based on the above technical concept, the anchoring unit can also be configured as a friction part that can generate friction, for example, by using a friction material that can provide greater friction or by setting the corresponding position as a friction surface, so as to increase the friction between the valve stent and the autologous valve annulus on that side, which can also play the role of anchoring one side of the valve.

[0020] By adopting a combined structure of main frame and auxiliary frame, the auxiliary frame can be directly applied to existing valve stents to achieve the above-mentioned functions, thereby further expanding the application scope of the valve stent of the present invention. Attached Figure Description

[0021] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings in the embodiments will be briefly described below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 This is a schematic diagram of the aortic structure, which presents as a curved tube structure in special cases such as transverse heart position and acute-angled aortic arch.

[0023] Figure 2This is a schematic diagram of the aortic valve inflow end being tilted during the aortic valve implantation and release process.

[0024] Figure 3 This is a schematic diagram of the aortic valve stent structure according to an embodiment of the present invention.

[0025] Figure 4 This is a schematic diagram of one embodiment of the external frame of the aortic valve stent according to an embodiment of the present invention.

[0026] Figure 5 This is a schematic diagram of another embodiment of the external frame of the aortic valve stent according to the present invention.

[0027] Figure 6 This is a schematic diagram of the aortic valve structure according to an embodiment of the present invention.

[0028] Figure 7 This is a schematic diagram illustrating the state in which the aortic valve is anchored at the inflow end on the outer diameter side of the aorta via barbs, according to an embodiment of the present invention.

[0029] Figure 8 This is a schematic diagram of the final implantation state and implantation position of the aortic valve after self-adjustment according to an embodiment of the present invention.

[0030] in: 11. Descending aorta, 12. Ascending aorta, 13. Aortic arch, 14. Autologous valve ring, 101. Curved tube structure axis, 102. Large diameter side, 103. Small diameter side; 20. Aortic valve; 21. Main frame; 22. Secondary frame; 23. Barb; 201. Inflow end; 202. Outflow end; 30. Conveying system. Detailed Implementation

[0031] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are some embodiments of the present invention, but not all embodiments.

[0032] This invention relates to an aortic valve and aortic valve stent that can be implanted in complex implantation scenarios such as transverse heart and acute-angled aortic arch, in order to solve the problem of difficulty in ensuring the final implantation position and implantation status of the aortic valve.

[0033] like Figure 1 As shown, in cases such as transverse heart position and acute-angle aortic arch, the descending aorta 11, aortic arch 13 and ascending aorta 12 form a large-angle curved tube structure. After the valve is delivered to the implantation position using an adjustable delivery system, the delivery system releases the aortic valve, thus realizing the implantation of the aortic valve.

[0034] Based on the preceding analysis, we know that due to factors such as the difference in the radius of curvature between the large-diameter and small-diameter sides of the curved structure, the implantation and release operation method, and the structural characteristics of the aortic valve stent, existing aortic valves may exhibit problems such as the inflow end of the aortic valve tilting relative to the vertical plane of the curved structure axis during implantation, and the uncontrollable movement adjustment process during the self-adjustment of the aortic valve, leading to uncontrollable final implantation position and implantation status of the aortic valve.

[0035] CN120036994A is a patent application filed by the applicant for a valve stent. In this patent application, an outer frame is set on the outside of the valve frame of the valve stent, and multiple support feet are set along the circumference of the outer frame. When the valve is implanted into the implantation position on the inside of the autologous valve leaflet, it is supported by the support feet to the inside of the autologous valve annulus, thereby anchoring the valve in the implantation position. This solves the problem that the valve is easily pushed into the ventricle or displaced towards the distal end under the action of blood flow pressure.

[0036] In the aforementioned valve stent structure, because support legs are provided around the entire circumference of the external stent, when it is applied to implantation operations in complex scenarios such as transverse heart and acute-angle aortic arch, when the inflow end of the valve is released, the valve is anchored to the aortic valve at various positions in the circumferential direction through the support legs. When the outflow end of the valve is released, due to the anchoring effect between the valve stent and the aorta in the circumferential direction, the valve's self-adjustment at the implantation position will be restricted, making it difficult for the valve to be adjusted to a state perpendicular to the axis of the curved structure. As a result, the final implantation state and accuracy of the implantation position of the valve cannot be guaranteed.

[0037] Based on the practical problems discovered in the above applications, this invention improves the structure by setting the anchoring unit only on one side of the aortic valve stent. Compared with the structure in CN120036994A that sets anchoring units in the circumferential direction, this invention effectively solves the problems existing in implantation operations in complex implantation scenarios such as transverse heart and acute-angle aortic arch.

[0038] In some embodiments of the present invention, reference is made to Figure 1 An anchoring unit is placed on the aortic valve stent near the inflow end. The anchoring unit is located on one side of the aortic valve stent. During the release process of aortic valve implantation, the interaction force between the anchoring unit and the autologous valve annulus restricts the movement of the aortic valve stent along the axial direction of the aortic valve on the side where the anchoring unit is located.

[0039] The inflow end 201 of the aortic valve stent refers to the end where blood flows in with reference to the direction of blood flow when the aortic valve is implanted. Correspondingly, the outflow end 202 refers to the end where blood flows out of the aortic valve.

[0040] Reference Figure 7 Through the interaction between the anchoring unit and the autologous valve annulus, during the self-adjustment process of the aortic valve stent, the movement of the aortic valve stent on the side facing the large diameter of the curved structure is restricted. Since only the other side of the aortic valve stent can move at this time, the inflow end on that side self-adjusts with the inflow end on the side where the anchoring unit is located as the reference position. Furthermore, because only one side can move, the tilted inflow end at this time allows the moving side of the valve stent to self-adjust more fully, thereby adjusting the inflow end to a state perpendicular to the axis of the curved structure. Figure 8 As shown. This anchoring unit, by acting as an anchoring reference and a self-adjusting benchmark during implantation and release, effectively ensures the accuracy and reliability of the final implantation state and location of the aortic valve.

[0041] In some embodiments, refer to Figure 3 The anchoring unit is one or more barbs 23 extending outward on the aortic valve stent, through which the aortic valve stent can form an anchoring connection with the autologous valve annulus on this side.

[0042] In some embodiments, the anchoring unit is a friction portion disposed on the aortic valve stent. The friction force generated when the friction portion contacts the autologous valve annulus restricts the movement of the aortic valve stent along the axial direction of the aortic valve on that side. The friction portion may be made of a friction material capable of providing high frictional force, or the corresponding position of the valve stent may be designated as a friction surface to increase the frictional force between the valve stent and the autologous valve annulus on that side, thereby restricting the movement of the valve stent on that side. The friction surface may have an uneven structure or a knurled structure formed on its surface.

[0043] like Figure 3 , Figure 4 and Figure 5 In some embodiments, the aortic valve stent includes a main frame 21 and an auxiliary frame 22 covering the outside of the main frame, with an anchoring unit disposed on the auxiliary frame 22.

[0044] like Figure 4 and Figure 5 In some embodiments, the auxiliary frame 22 is a wave-shaped support structure, and the barbs 23 are formed by bending one or more trough ends of the wave-shaped support outward.

[0045] The end of the barb 23 can be configured as a fork-shaped structure, or other structures that can form a stable anchoring connection with the autologous valve ring.

[0046] like Figure 4 In some embodiments, the auxiliary frame 22 has an annular structure that cooperates with the main frame, and one or more barbs 23 are formed on one side of the auxiliary frame 22.

[0047] like Figure 5 In some embodiments, the auxiliary frame 22 is a semi-ring structure that cooperates with the main frame. The auxiliary frame is disposed on one side of the main frame, and one or more barbs 23 are formed on the auxiliary frame.

[0048] The stent can be made of the same material as the main stent, or other materials suitable for valve stents. In the above embodiments, the stent and its barbs can be integrally formed from a single piece of tubing, or woven together.

[0049] Both the primary and secondary stents used as valve stents have two different forms: one is a contracted form when installed in the sheath of the delivery system, and the other is an expanded form that can expand to fit into human tissue after implantation.

[0050] The auxiliary frame and the main frame can be connected by binding wire, or by other connection methods such as welding or riveting.

[0051] On the other hand, the present invention also provides an aortic valve 20 employing the aortic valve stent described in the above embodiments, referring to... Figure 6 As shown.

[0052] Reference Figure 7 During aortic valve implantation, the delivery system 30 adjusts the aortic valve's position so that the anchoring unit faces the large-diameter side of the autologous valve annulus. When the aortic valve is released, the anchoring unit is anchored to the large-diameter side of the autologous valve annulus. The anchoring effect of the anchoring unit on this side ensures the accuracy of the final implantation state and position of the valve.

[0053] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., used to indicate the orientation or positional relationship are based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship that the product of this invention is usually placed in during use. They are only for the convenience of describing this invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0054] Furthermore, the use of terms such as "horizontal" and "vertical" in the description of this invention does not imply that the components are required to be absolutely horizontal or suspended, but rather that they can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0055] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0056] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Any simple modifications or equivalent changes made to the above embodiments based on the technical essence of the present invention shall fall within the protection scope of the present invention.

Claims

1. An aortic valve stent, characterized in that, Used for aortic valves, enabling aortic valves to be implanted in the aorta, which has a curved structure; An anchoring unit is provided on the aortic valve stent near the inflow end. The anchoring unit is located on one side of the aortic valve stent. During the release process of aortic valve implantation, the interaction force between the anchoring unit and the autologous valve annulus restricts the movement of the aortic valve stent along the axial direction of the aortic valve on the side where the anchoring unit is located.

2. The aortic valve stent according to claim 1, characterized in that, The anchoring unit is one or more barbs extending outward from the aortic valve stent, which can form an anchoring connection with the autologous valve annulus on this side through the barbs.

3. The aortic valve stent according to claim 1, characterized in that, The anchoring unit is a friction part provided on the aortic valve stent. The friction force generated when the friction part contacts the autologous valve annulus restricts the movement of the aortic valve stent along the axial direction of the aortic valve on this side.

4. The aortic valve stent according to claim 1, characterized in that, The aortic valve stent includes a main stent and an auxiliary stent covering the outside of the main stent, and the anchoring unit is disposed on the auxiliary stent.

5. The aortic valve stent according to claim 4, characterized in that, The anchoring unit is one or more barbs extending outward on the stent, through which the aortic valve stent can form an anchoring connection with the autologous valve annulus on this side.

6. The aortic valve stent according to claim 5, characterized in that, The auxiliary frame is a wave-shaped support structure, and the barbs are formed by bending one or more trough ends of the wave-shaped support outward.

7. The aortic valve stent according to claim 4, characterized in that, The anchoring unit is a friction part installed on the stent. The friction force generated when the friction part contacts the autologous valve annulus restricts the movement of the aortic valve stent along the axial direction of the aortic valve on this side.

8. The aortic valve stent according to any one of claims 2, 5, or 6, characterized in that, The ends of the barbs have a forked structure.

9. The aortic valve stent according to any one of claims 4, 5, 6, or 7, characterized in that, The auxiliary frame has a ring-shaped structure.

10. The aortic valve stent according to any one of claims 4, 5, 6, or 7, characterized in that, The auxiliary frame has a semi-ring structure.

11. An aortic valve, characterized in that, Includes the aortic valve stent according to any one of claims 1-10.

12. The aortic valve according to claim 11, characterized in that, When the aortic valve is implanted, the anchoring unit is positioned towards the large diameter side of the autologous valve annulus so that when the aortic valve is released, the anchoring unit is anchored to the large diameter side of the autologous valve annulus, which is the outward-facing side of the curved tube structure.

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