Aortic valve stent and system for delivering an aortic valve stent

Abstract

Embodiments of the present application provide an aortic valve stent and a system for delivering the aortic valve stent. The aortic valve stent includes: a stent body having a contracted state and a deployed state, the stent body being capable of being delivered in the contracted state and switched to the deployed state behind the aortic valve; a valve disposed inside the stent body; and a first positioning portion and a second positioning portion disposed outside the stent body. When the stent body is in the deployed state, the first positioning portion and the second positioning portion can be respectively located on both sides of the leaflets of the aortic valve to fix the stent body at the aortic valve. The aortic valve stent and the system for delivering the aortic valve stent according to the embodiments of the present application can better fix the aortic valve stent at the aortic valve and avoid displacement of the aortic valve stent.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and particularly relates to an aortic valve stent and a system for delivering the aortic valve stent. Background Art

[0002] An aortic valve stent can be implanted at the aortic valve to treat diseases such as aortic valve stenosis, insufficiency or regurgitation. During the release process of the aortic valve stent in the prior art, displacement occurs under the combined action of blood impact and changes in the tension of the delivery system. For example, even if the existing valve products are accurately positioned before release, during the release process, the valve is extremely likely to slide towards the left ventricle, resulting in stent placement failure or being placed too deeply, leading to serious complications such as paravalvular leakage and atrioventricular block. Summary of the Invention

[0003] In view of the above problems, the present application is proposed to provide an aortic valve stent and a system for delivering the aortic valve stent that can overcome the above problems or at least partially solve the above problems. This system can not only treat aortic valve stenosis percutaneously, but also treat aortic valve regurgitation.

[0004] According to the first aspect of the embodiments of the present application, there is provided an aortic valve stent, including: a stent body having a contracted state and a deployed state, the stent body being capable of being delivered in the contracted state and being switched to the deployed state after reaching the aortic valve; a valve disposed inside the stent body; and a first positioning portion and a second positioning portion disposed outside the stent body. When the stent body is in the deployed state, the first positioning portion and the second positioning portion can be respectively located on both sides of the aortic valve to fix the stent body at the aortic valve.

[0005] According to the second aspect of the embodiments of the present application, there is provided a system for delivering an aortic valve stent, including: the aortic valve stent as described in the first aspect of the embodiments of the present application, and a delivery device. The aortic valve stent can be loaded on the delivery device when the stent body is in the contracted state, and the delivery device can deliver the aortic valve stent to the aortic valve and release the aortic valve stent to switch the stent body to the deployed state.

[0006] The aortic valve stent and the system for delivering the aortic valve stent according to the embodiments of the present application can better fix the aortic valve stent at the aortic valve and avoid displacement of the aortic valve stent. Brief Description of the Drawings

[0007] Figure 1a and Figure 1b is a schematic diagram of the aortic valve stent according to the embodiments of the present application;

[0008] Figure 2 Schematic diagram of the valve of the aortic valve stent according to an embodiment of the present application;

[0009] Figure 3 Schematic diagram of the aortic valve stent according to an embodiment of the present application being fixed at the aortic valve;

[0010] Figure 4a and Figure 4b Schematic diagram of the aortic valve stent and its usage state according to another embodiment of the present application;

[0011] Figure 5 Schematic diagram of the usage state of the aortic valve stent according to still another embodiment of the present application;

[0012] Figure 6 Schematic diagram of the aortic valve stent according to yet another embodiment of the present application;

[0013] Figure 7 Schematic diagram of the aortic valve stent according to yet another embodiment of the present application;

[0014] Figures 8a - 8e Schematic diagram of the system for delivering the aortic valve according to an embodiment of the present application releasing the loaded aortic valve stent;

[0015] Figures 9a - 9b Schematic diagram of the system for delivering the aortic valve according to an embodiment of the present application releasing the aortic valve stent at the aortic valve;

[0016] Figure 10a and Figure 10b Schematic diagram of the system for delivering the aortic valve according to another embodiment of the present application. Detailed implementation manners

[0017] To make the objectives, technical solutions and advantages of the present application clearer, the technical solutions of the present application will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present application. Obviously, the described embodiments are only one embodiment of the present application, rather than all embodiments. All other embodiments obtained by those of ordinary skill in the art based on the described embodiments of the present application without creative efforts shall fall within the scope of protection of the present application.

[0018] It should be noted that, unless otherwise defined, the technical terms or scientific terms used in this application should have the ordinary meanings understood by those with ordinary skills in the field to which this application belongs. If descriptions such as "first", "second", etc. are involved throughout the text, these "first", "second", etc. descriptions are only used to distinguish similar objects, and cannot be understood as indicating or implying their relative importance, sequence, or implicitly indicating the quantity of the indicated technical features. It should be understood that the data described by "first", "second", etc. can be interchanged under appropriate circumstances. If "and / or" appears throughout the text, its meaning includes three parallel scenarios. Taking "A and / or B" as an example, it includes scenario A, or scenario B, or the scenario where both A and B are satisfied simultaneously.

[0019] According to the first aspect of the embodiments of the present application, an aortic valve stent 10 is provided. Referring to Figures 1a - 3 , the aortic valve stent 10 includes a stent body 11. The stent body 11 has a contracted state and a deployed state. The stent body 11 can be delivered in the contracted state and switched to the deployed state after reaching the aortic valve; a valve 12 disposed inside the stent body 11; and a first positioning portion 13 and a second positioning portion 14 disposed outside the stent body 11. When the stent body 11 is in the deployed state, the first positioning portion 13 and the second positioning portion 14 can be respectively located on both sides of the leaflets of the aortic valve to fix the stent body 11 at the aortic valve.

[0020] Figure 1a Shown is the structure of the stent body 11 in the deployed state. Figure 1b Shown is the structure of the stent body 11 in the contracted state. The stent body 11 can be a cylindrical structure composed of a grid. The grid can be a rhombus shape shown in the figure or other irregular shapes, such as a quasi-rhombus shape surrounded by four arc-shaped sides, etc. The advantage of the rhombus shape structure is that it is easy for the stent body 11 to contract and deploy. In the contracted state, the rhombic grid structure of the stent body 11 can be compressed, thereby reducing the diameter of the stent body 11, enabling the aortic valve stent 10 to be loaded into the delivery device. The delivery device can be a commonly used transcatheter delivery device in the art. After the delivery device delivers the aortic valve stent 10 to the aortic valve, the stent body 11 can be switched to the deployed state and thus fixed at the aortic valve.

[0021] In some embodiments, the stent body 11 can be made of nitinol. Nitinol has a certain flexibility at lower temperatures. Ice water or the like can be used to cool the stent body 11, making it easier to be compressed into a contracted state and loaded into the delivery device. After the aortic valve stent 10 is delivered to the aortic valve, the delivery device can release the aortic valve stent 10. Since the temperature inside the human body is relatively high, the flexibility of the stent body 11 decreases at such a temperature, so that it can expand automatically relatively quickly, facilitating the fixation of the aortic valve stent 10. In some other embodiments, those skilled in the art can also use other types of shape memory alloys or any other suitable materials to make the stent body, and no specific limitation is made thereto.

[0022] The diameter of the stent body 11 can be determined according to the inner diameter of the patient's aorta, so that the top end of the stent body 11 can abut against the aortic wall, and the first positioning portion 13 and the second positioning portion 14 can jointly fix the stent body 11.

[0023] Figure 2 The internal structure of the aortic valve stent 10 is shown. A valve 12 is arranged inside the stent body 11. The valve 12 generally includes three leaflets. The valve 12 can be used to realize the function of the aortic valve. Specifically, when the left ventricle contracts, the leaflets will rise under the impact of blood flow, and gaps will appear between the leaflets, enabling the blood in the left ventricle to be pumped into the aorta. When the left ventricle relaxes, the leaflets will descend, and the leaflets will be opposed along the joining edge to prevent the blood in the aorta from flowing back into the left ventricle.

[0024] The valve 12 can be sewn on the stent body 11. In some embodiments, a skirt can be formed at one end of the valve 12 close to the stent body 11. The skirt can increase the contact area between the valve 12 and the stent body 11, so as to better fix the valve 12 to the stent body 11 and prevent the valve 12 from accidentally falling off.

[0025] In some embodiments, the valve 12 can be made of porcine pericardium, bovine pericardium, equine pericardium, etc. In some other embodiments, the valve 12 can also be made of other suitable biomimetic materials, such as the polymer material polytetrafluoroethylene or polyester cloth, etc., and no specific limitation is made thereto.

[0026] Refer to Figure 1a and Figure 3 As shown in, a first positioning portion 13 and a second positioning portion 14 are arranged on the outer side of the stent body 11. The first positioning portion 13 and the second positioning portion 14 can be fixed to the stent body 11 by suture or welding. Those skilled in the art can also use other suitable methods to fix the first positioning portion 13 and the second positioning portion 14 to the stent body 11, and no specific limitation is made thereto.

[0027] As Figure 3 shown, when the aortic valve stent 10 is disposed at the aortic valve, the first positioning portion 13 and the second positioning portion 14 will be respectively located on both sides of the leaflets of the aortic valve. Specifically, behind each leaflet of the aortic valve, the aortic wall bulges outwards, forming an aortic sinus between the leaflet of the aortic valve and the aortic wall. The first positioning portion 13 will be located in the aortic sinus. At this time, the main body of the first positioning portion 13 will abut against the leaflet of the aortic valve, and the bottom will abut against the bottom of the aortic sinus, which is conducive to positioning during the release of the aortic valve stent 10. The second positioning portion 14 will be located on the side of the leaflet of the aortic valve away from the aortic wall and abut against the leaflet of the aortic valve, thereby cooperating with the first positioning portion 13 to fix the aortic valve stent 10.

[0028] The number of the first positioning portions 13 and the second positioning portions 14 is adapted to the number of the leaflets of the aortic valve, that is, usually 3 first positioning portions 13 and 3 second positioning portions 14 are provided. In some embodiments, for patients with only 2 leaflets of the aortic valve, only 2 first positioning portions 13 and 2 second positioning portions 14 may also be provided. In some embodiments, the number of the first positioning portions 13 and the second positioning portions 14 may also be different from the number of the leaflets of the aortic valve, and such embodiments will be described in detail in the relevant parts below.

[0029] In this embodiment, the aortic valve is clamped between the first positioning portion 13 and the second positioning portion 14, so that it can not only prevent the aortic valve stent 10 from shifting upwards under the impact of the blood in the left ventricle during left ventricular contraction, but also prevent the aortic valve stent 10 from shifting downwards under the impact of the blood in the aorta during left ventricular relaxation, obtaining a better fixing effect.

[0030] In some embodiments, still referring to Figure 1a and Figure 1b , the first positioning portion 13 and the second positioning portion 14 may be arranged in an arc shape, so that not only can the first positioning portion 13 and the second positioning portion 14 have a larger contact area and obtain a better fixing effect, but also the volume of the aortic valve stent 10 can be reduced as much as possible.

[0031] In some embodiments, referring to Figure 1b, when the stent body 11 is in a contracted state, the first positioning portion 13 can be at least partially located outside the second positioning portion 14. Specifically, the ends of the first positioning portion 13 and the second positioning portion 14 will have a certain overlap, and the end of the first positioning portion 13 is outside the end of the second positioning portion 14. Thus, during the process of releasing the aortic valve stent 10, the first positioning portion 13 can open before the second positioning portion 14, and then the bottom of the first positioning portion 13 can be positioned at the sinus bottom of the aortic valve first, and then the second positioning portion 14 can be opened to complete the clamping of the aortic valve, which is convenient for operation. Moreover, such an overlap enables the first positioning portion 13 and the second positioning portion 14 to cooperate with each other when clamping the leaflets of the aortic valve, achieving a better fixing effect.

[0032] In some embodiments, referring to Figure 4a and Figure 4b , one end of the first positioning portion 13 away from the stent body 11 bends towards the stent body 11 to form a first hook-shaped body 131, and one end of the second positioning portion 14 away from the stent body 11 bends away from the stent body 11 to form a second hook-shaped body 141. The first hook-shaped body 131 and the second hook-shaped body 141 can cooperate with each other to clamp the leaflets of the aortic valve between the first positioning portion 13 and the second positioning portion 14.

[0033] Specifically, referring to Figure 4b , in such an embodiment, the bent portion of the first hook-shaped body 131 will abut against the sinus bottom of the aortic valve, and the end of the first hook-shaped body 131 will abut against the leaflet of the aortic valve. The bent portion of the second hook-shaped body 141 will push the end of the leaflet of the aortic valve to form a certain curl and enter the position between the first hook-shaped body 131 and the second hook-shaped body 141, and the end of the second hook-shaped body 141 will abut against the leaflet of the aortic valve. Thus, a more stable clamping of the leaflets of the aortic valve is formed.

[0034] In such an embodiment, those skilled in the art can reasonably set the angles of the bent portions of the first hook-shaped body 131 and the second hook-shaped body 141, as well as the included angles formed between the first positioning portion 13 and the second positioning portion 14 and the stent body 11 in the opened state of the stent body 11, so as to obtain the desired clamping effect. In some embodiments, preferably, the included angle formed between the first positioning portion 13 and the stent body 11 in the deployed state of the stent body 11 is 30 - 70 degrees.

[0035] In some embodiments, when the stent body 11 is in a contracted state, the first positioning portion 13 and the second positioning portion 14 can be in a straight state. For example, they can be flattened under the pressure of the sheath wall of the delivery system. At this time, the first hook-shaped body 131 and the second hook-shaped body 141 disappear due to being flattened. After the stent body 11 is released, the first positioning portion 13 and the second positioning portion 14 pop out, and due to the loss of pressure, the ends of the first positioning portion 13 and the second positioning portion 14 are bent to re-form the first hook-shaped body 131 and the second hook-shaped body 141. Those skilled in the art can use materials such as shape memory alloy to achieve the above effects, and no specific limitations are imposed thereon. Such an embodiment can reduce the overall diameter of the aortic valve stent 10 when the stent body 11 is in a contracted state, facilitating loading and release.

[0036] One advantage of providing the first hook-shaped body 131 and the second hook-shaped body 141 is that the first hook-shaped body 131 and the second hook-shaped body 141 can cooperate with each other to form a more stable clamping of the leaflets of the aortic valve, further preventing the displacement of the aortic valve stent 10. Especially for some patients with aortic valve regurgitation, there are no calcification foci on the leaflets of their aortic valves, which are relatively soft, and it may be difficult to ensure the stability of the position of the aortic valve stent using other methods provided in the related art. Moreover, during the release process, it may be necessary to slide the first positioning portion 13 along the aortic wall. Compared with the first positioning portion 13 designed as a straight bar, providing the first hook-shaped body 131 can also prevent the relatively sharp part of the first positioning portion 13 from directly contacting the aortic wall, avoiding damage.

[0037] As described above, the number of the first positioning portion 13 and the second positioning portion 14 can be adapted to the number of the leaflets of the aortic valve. Since the clamping formed by the first hook-shaped body 131 and the second hook-shaped body 141 on the leaflets is very stable, it is difficult to adjust the clamping position of the first hook-shaped body 131 and the second hook-shaped body 141 again after the clamping is formed. In actual applications, it is usually desired that the aortic valve stent 10 can ensure good coaxiality with the aorta (the axis of the aortic valve stent 10 is substantially coincident with the axis of the aortic lumen). If the aortic valve stent 10 is placed obliquely, it may lead to serious complications such as paravalvular leakage. If the first hook-shaped body 131 and the second hook-shaped body 141 are provided on each of the first positioning portion 13 and the second positioning portion 14, then during the actual release process of the aortic valve stent 10 by the operator, it may take a lot of time to adjust the angle before the first positioning portion 13 is released or after it is released and opened, and then release the second positioning portion 14, so as to ensure good coaxiality between the finally released aortic valve stent 10 and the aorta.

[0038] Based on this, in some embodiments, the first hook-shaped bodies 131 and the second hook-shaped bodies 141 may be provided only on some of the first positioning portions 13 and the second positioning portions 14. For example, the first hook-shaped bodies 131 and the second hook-shaped bodies 141 are provided only on one corresponding first positioning portion 13 and one second positioning portion 14, while the other first positioning portions 13 and second positioning portions 14 may be arranged in an arc shape as described above.

[0039] Alternatively, it is not necessary to provide the first positioning portions 13 and the second positioning portions 14 at each leaflet. For example, the first positioning portions 13 and the second positioning portions 14 are provided only at one leaflet, and the first hook-shaped bodies 131 and the second hook-shaped bodies 141 are provided on the first positioning portions 13 and the second positioning portions 14. In such an embodiment, after the first hook-shaped bodies 131 and the second hook-shaped bodies 141 have formed a very firm clamping on one leaflet, if the coaxiality between the aortic valve stent 10 and the aorta is not good, a certain torque will be generated, so that one side of the aortic valve stent 10 where the first positioning portions 13 and the second positioning portions 14 are not provided, or one side where only the first positioning portions 13 and the second positioning portions 14 are provided but the first hook-shaped bodies 131 and the second hook-shaped bodies 141 are not provided can move to a certain extent under the action of this torque to achieve automatic alignment. Thus, during the process of releasing the aortic valve stent 10 by the operator, the positioning of the aortic valve stent can be quickly completed without consuming a long time for angle adjustment.

[0040] Furthermore, in this embodiment, there is another advantage in providing the first hook-shaped bodies 131 and the second hook-shaped bodies 141. Figure 5 The left part in shows a schematic diagram of an aortic valve stent in a related art disposed at the aortic valve. It can be understood that coronary openings are formed above the aortic sinuses. In the related art, the aortic valve stent is disposed inside the leaflets of the aortic valve, so that the leaflets of the aortic valve will adhere to the wall of the aorta under the extrusion of the aortic valve stent. If the coronary openings of the patient are relatively low and / or the leaflets of the aortic valve are relatively long, it may cause the coronary openings to be blocked by the leaflets.

[0041] In this embodiment, referring to Figure 5 the right part in, the leaflets of the aortic valve will be restricted in the gap formed between the first hook-shaped bodies 131 and the second hook-shaped bodies 141 instead of adhering closely to the aortic wall, thereby avoiding the leaflets of the aortic valve from blocking the coronary openings. In some embodiments, in order to further avoid blocking the coronary openings, the first positioning portion 13 may form a relatively large angle with the stent body 11 when the stent body 11 is in the open state. For example, an angle of 30 - 70 degrees is formed.

[0042] In some embodiments, still referring toFigure 4a and Figure 4b At the end of the first hook-shaped body 131, a first thorn-shaped body 132 is formed, and / or at the end of the second hook-shaped body 141, a second thorn-shaped body 142 is formed. The first thorn-shaped body 132 and the second thorn-shaped body 142 can at least partially penetrate into the leaflets of the aortic valve, so as to further improve the stability of clamping.

[0043] In some embodiments, barbs may be formed on the first thorn-shaped body 132 and / or the second thorn-shaped body 142, so that it is difficult for the first thorn-shaped body 132 and the second thorn-shaped body 142 to slide out after penetrating into the leaflets of the aortic valve, further improving the stability of clamping.

[0044] In some embodiments, magnetic members that attract each other may be provided on the first hook-shaped body 131 and the second hook-shaped body 141, or magnetic members that attract each other may be provided on the first thorn-shaped body 132 and the second thorn-shaped body 142. The magnetic members can cause the first hook-shaped body 131 and the second hook-shaped body 141 to move towards each other under the action of mutual attraction during the release process, more easily forming a clamp on the leaflets of the aortic valve, and being able to maintain the clamped state relatively stably after forming the clamp.

[0045] In some embodiments, referring to Figure 6 , the aortic valve stent 10 further includes a traction wire 15. The traction wire 15 can pass through the second hook-shaped body 141 and be connected to the first hook-shaped body 131. Thus, the traction wire 15 can pull the first hook-shaped body 131 to move towards the second hook-shaped body 141.

[0046] Specifically, although the first hook 131 and the second hook 141 are set to cooperate with each other, during the actual release process, due to the different sizes and thicknesses of the valve leaflets of each patient, the clamping effect formed may not be stable enough. For example, the clamping may not be tight enough. Therefore, in this embodiment, a traction wire 15 is provided. One end of the traction wire 15 can pass through the second hook 141 (here, passing through means that the traction wire 15 can pass through a certain part of the second hook 141 and can slide relative to the second hook 141) and the first hook 131. Thus, after the release of the first hook 131 and the second hook 141 is completed, the two ends of the traction wire 15 can be operated (for example, by a delivery device) to make the first hook 131 move towards the second hook 141 to achieve a tighter clamping. It can be understood that after the first hook 131 moves towards the second hook 141 to achieve a tight enough clamping, the operation of the traction wire 15 can be stopped, and even if the acting force of the traction wire 15 is lost, it will not cause the first hook 131 and the second hook 141 to displace again and affect the clamping effect. Further, after the traction is completed, one end of the traction wire 15 can be operated to pull the traction wire 15 out of the patient's body.

[0047] In some embodiments, the traction wire 15 can be configured to at least partially cut the valve leaflets of the aortic valve clamped between the first hook 131 and the second hook 141 during the process of pulling the first hook 131 towards the second hook 141. It can be understood that after the first hook 131 and the second hook 141 are released, the traction wire 15 will be at the end of the valve leaflets of the aortic valve. The traction wire 15 can be set to have sufficient strength so that during the traction of the first hook 131, the traction wire 15 can cut the valve leaflets of the aortic valve starting from the end of the valve leaflets of the aortic valve to further ensure that the valve leaflets of the aortic valve do not block the coronary artery opening.

[0048] In some embodiments, a frosted layer can be provided at the positions where the first positioning portion 13 and the second positioning portion 14 contact the valve leaflets of the aortic valve. This frosted layer can increase the friction between the first positioning portion 13 and the second positioning portion 14 and the valve leaflets of the aortic valve, and further prevent the displacement of the aortic valve stent 10. Those skilled in the art can determine the position where the frosted layer is provided according to the actual situation, and no limitation is made thereto.

[0049] It should be noted that in some embodiments, with reference to Figure 5, during the process of releasing the aortic valve stent 10, it may be necessary to slide the first positioning portion 13 up and down along the aortic wall to adjust the position. Therefore, the position on the first positioning portion 13 that comes into contact with the aortic wall, that is, the starting curling position, cannot be provided with a matte layer (even if this position may come into contact with the leaflets of the aortic valve subsequently), to facilitate the operation of the operator.

[0050] In some embodiments, still referring to Figure 5 , the stent body 11 may include a contraction section 111 and expansion sections 112 provided at both ends of the contraction section. Among them, the inner diameter of the expansion section 112 gradually increases in the direction away from the contraction section 111. That is, the stent body 11 may be an aortic valve stent with a relatively long body used in the related art in this field. Among them, the contraction section 111 is the part with a smaller inner diameter in the middle of the body, and the expansion section 112 is the part with a gradually increasing inner diameter connected above and below the contraction section 111. The contraction section 111 and the expansion section 112 may be integrally formed. Those skilled in the art can refer to the related art in this field to specifically set the lengths, inner diameters, and connection methods of the expansion section 112 and the contraction section 111, and no specific limitations are made in this regard.

[0051] In this embodiment, the valve 12 and the first positioning portion 13 may be provided on the contraction section 111. Thus, referring to Figure 4b , there will be no obstruction in the section of the contraction section 111 located above the valve 12 and the first positioning portion 13, and blood can smoothly flow into the coronary artery opening through this position.

[0052] In some embodiments, referring to Figure 7 , the aortic valve stent 10 may further include a contraction ring 16 provided in the middle of the stent body 11. The contraction ring 16 will contract the middle of the stent body 11 when the stent body 11 is in the deployed state, so that the diameter of the middle of the stent body 11 is smaller than that of both ends. In this embodiment, since the middle of the stent body 11 is contracted by the contraction ring 16, it will further drive the aortic valve clamped by the first positioning portion 13 and the second positioning portion 14 away from the aortic wall, avoiding obstruction to the coronary artery opening. Compared with the contraction section, the contraction ring 16 can achieve a better contraction effect, especially for embodiments with a relatively long stent body 11.

[0053] In some embodiments, the shrinkage ring 16 can be made of a flexible material to avoid affecting the shrinkage of the stent body 11. In some other embodiments, the shrinkage ring 16 can adopt a structure of multiple rigid arcs connected by a flexible material, which can not only avoid affecting the shrinkage of the stent body 11, but also provide a better shrinkage effect when the stent body 11 is deployed. Those skilled in the art can also adopt other ways to reasonably set the shrinkage ring 16, and no specific limitation is made thereto. In some embodiments, the number of shrinkage rings 16 is not limited to one, and multiple shrinkage rings can also be provided to obtain a better shrinkage effect and / or make the shape of the stent body 11 in the deployed state more in line with expectations.

[0054] In some embodiments, the shrinkage ring 16 is disposed on the side of the first positioning portion 13 away from the second positioning portion 14, that is, above the connection between the first positioning portion 13 and the stent body 11. Thus, the shrinkage ring 16 can better limit the angle of the first positioning portion 13 and avoid blocking the coronary artery opening.

[0055] In some embodiments, still referring to Figure 1a , the aortic valve stent 10 further includes a connection ring 17 disposed at one end of the stent body 11. The connection ring 17 is used to load the stent body 11 on the delivery device. Specifically, the connection ring 17 can be disposed at the top end of the stent body 11. During the release process, the connection ring 17 will be the last part of the aortic valve stent 10 to leave the delivery device. In the case where the aortic valve stent 10 has been partially released but the connection ring 17 has not been disconnected from the delivery device, the aortic valve stent 10 can still be compressed into the delivery device, so that the placement position of the aortic valve stent 10 can be readjusted.

[0056] The hollow portion in the middle of the connection ring 17 can be circular, rectangular, hexagonal, etc. The connection ring can be welded to the stent body 11 by a short rod or sewn on the stent body 11, and no specific limitation is made thereto. In some embodiments, multiple connection rings 17 can be provided at one end of the stent body 11 at the same interval, for example, 3 connection rings are provided in a centrosymmetric form, so as to avoid deviation during the recovery process and cause recovery failure.

[0057] In some embodiments, a connection ring 17 can also be disposed at the bottom end of the stent body 11, so that the lower half of the stent body 11 and the second positioning portion 14 can also be retracted into the delivery device before being completely released.

[0058] In some embodiments, both ends of the stent body 11 can expand outwardly in a flared shape. Among them, the flared structure formed by the expansion of the top end of the stent body 11 can enable the top of the stent body 11 to abut more firmly against the wall of the aorta, further improving the fixation effect. The flared structure formed by the expansion of the bottom end of the stent body 11 can also further improve the fixation effect and prevent the upward displacement of the stent body 11.

[0059] An embodiment according to the present application also provides a system for delivering an aortic valve stent. Referring to Figures 8a - 8d , the system for delivering an aortic valve stent includes the aortic valve stent 10 described in any of the above embodiments, and a delivery device 20. The aortic valve stent 10 can be loaded onto the delivery device 20 when the stent body 11 is in a contracted state. The delivery device 20 can deliver the aortic valve stent 10 to the aortic valve and release the aortic valve stent 10 to switch the stent body 11 to an expanded state, thereby fixing the aortic valve stent 10 at the aortic valve.

[0060] As described above, the delivery device 20 can be a commonly used transcatheter delivery device in the art. Specifically, after the aortic valve stent 10 is loaded onto the delivery device 20, the delivery device 20 can reach the aortic valve through the aorta, and then release the aortic valve stent 10 to fix it at the aortic valve. It should be noted that Figures 8a - 8d , and Figures 9a - 9b the aortic valve stent 10 in

[0061] is only for illustration and does not constitute a limitation on the specific structure of the aortic valve stent 10 in the present application.

[0062] In some embodiments, the delivery device 20 can include a loading portion 21 and an operation portion 22. The loading portion 21 is used to load the aortic valve stent 10, and the operation portion 22 is used to operate the movement of the loading portion 21 to complete the device of the aortic valve stent 10 or release the aortic valve stent 10.

[0063] In some embodiments, the loading portion 21 may include a first housing 211 and a second housing 212. The first housing 211 and the second housing 212 can move under the operation of the operation portion 22 respectively. As described above, during the process of releasing the aortic valve stent 10, a more convenient way is to first release the first positioning portion 13 and the second positioning portion 14, and then release other parts after the positioning and fixation of the stent body 11 are completed. For this purpose, in this embodiment, the loading portion 21 includes two housings that can move independently, so that by separately operating the movements of the first housing 211 and the second housing 212, it is possible to control the desired part to be released preferentially. Specifically, during the process of releasing the aortic valve stent 10, the first housing 211 can slide towards the operation portion 22 under the operation of the operation portion 22, and the second housing 212 can slide in a direction away from the operation portion 22 under the operation of the operation portion 22.

[0064] In such an embodiment, correspondingly, the operation portion 22 may include a first operating member 221 for operating the first housing 211 and a second operating member 222 for operating the second housing 212. The first operating member 221 and the second operating member 222 may be structures such as knobs and push rods, and can be connected to the housing they operate through a transmission structure to operate the housing. Those skilled in the art can set them with reference to the operating members and transmission structures used in the conveying devices of related technologies, and no specific limitations are made here.

[0065] In some other embodiments, the first housing 211 and the second housing 212 may also move together under the operation of the operation portion 22. For example, a knob structure can be used to simultaneously control the first housing 211 and the second housing 212 to move towards each other to complete loading, or move away from each other to complete release. This will simplify the steps of the release operation, but it may be necessary to load the aortic valve stent 10 very precisely in order to release it in a desired manner.

[0066] In some other embodiments, the loading portion 21 may further include more housings. For example, it may further include a third housing and a fourth housing (not shown in the figure). The third housing and the fourth housing may correspond to the positions of the first positioning portion 13 and the second positioning portion 14, so that the third housing and the fourth housing can be moved first to release the first positioning portion 13 and the second positioning portion 14, and then other positions can be released after the positioning and fixation are completed.

[0067] In some embodiments, referring to Figure 8a, the first housing 211 is formed with a first accommodating cavity 213, and the second housing 212 is formed with a second accommodating cavity 214. When the aortic valve stent 10 is loaded into the loading part 21, the first positioning part 13 is located in the first accommodating cavity 213, and the second positioning part 14 is located in the second accommodating cavity 214.

[0068] In such an embodiment, the first housing 211 can be first operated to move in the direction of the operating part 22. Refer to Figure 8b , the movement of the first housing 211 causes the first positioning part 13 to leave the first accommodating cavity 213 and thus be released. When the first positioning part 13 has completely left the first accommodating cavity 213, the movement of the first housing 211 can be stopped, and positioning can be performed by means of the released first positioning part 13. As described above, after the first positioning part 13 is released, it will form an angle with the stent body 11, that is, the first positioning part 13 is in an outwardly expanded state, thus facilitating positioning.

[0069] During the movement of the first housing 211, the second positioning part 14 will still be in the second accommodating cavity 214 of the second housing 212. At this time, refer to Figure 9a , the second positioning part 14 will not block the first positioning part 13, enabling the first positioning part 13 to more smoothly enter the aortic sinus and be positioned at the sinus bottom. Specifically, the first positioning part 13 can be slid to the bottom of the aortic valve sinus by pushing and rotating the loading part 21.

[0070] After the positioning is completed, refer to Figure 8c , the second housing 212 can be moved so that the second positioning part 14 is released. Then, refer to Figure 9b , the second positioning part 14 and the first positioning part 13 complete the clamping of the aortic valve. After it is determined that the first positioning part 13 and the second positioning part 14 are relatively fixed in a more appropriate place, the second housing 212 can be continued to be moved in the direction away from the operating part 22 so that the lower half of the stent body 11 is completely released. Then, refer to Figure 8d , continue to move the first housing 211 to release the other parts of the stent body 11.

[0071] In some embodiments, as described above, when the stent body 11 is in a contracted state, the first positioning part 13 will be located outside the second positioning part 14, that is, there will be a certain overlapping part between the first positioning part 13 and the second positioning part 14. At this time, refer to Figure 8e , the length of the second housing 212 can be correspondingly increased so that it can enter the first housing 211 and partially be between the first positioning part 13 and the second positioning part 14 when the aortic valve stent 10 is loaded into the loading part 21. As Figure 8eThe structure at the overlapping area of the first positioning portion 13 and the second positioning portion 14 shown is, from the outside to the inside, the first housing 211, the first positioning portion 13, the second housing 212, and the second positioning portion 14. Thus, during the process of the first housing 211 moving and releasing the first positioning portion 13, the second positioning portion 14 can continue to be held without being released.

[0072] In some embodiments, as described above, the aortic valve stent 10 may be provided with a connecting ring 17. At this time, referring to Figures 8c - 8d , the loading portion 21 may further include a connecting member 215, and the connecting member 215 can move under the operation of the operating portion 22 to connect or disconnect from the connecting ring 17.

[0073] Specifically, the operating portion 22 may include a third operating member 223 for operating the connecting member 215. Under the operation of the third operating member 223, the connecting member 215 can move to connect or disconnect from the connecting ring 17. For example, the connecting member 215 may be rod-shaped and can move along the radial direction of the loading portion, so that it can move towards the center direction of the loading portion 21 to penetrate into the connecting ring 17 for connection, or move in the direction away from the center of the loading portion 21 to disconnect from the connecting ring 17. In some other embodiments, the top of the connecting member 215 can be switched to a hook shape and a wire shape under the operation of the third operating member 223. It can hook the connecting ring 17 for connection in the hook shape and disconnect from the connecting ring 17 in the wire shape. Those skilled in the art can also set the connecting member 215 in other suitable ways, and no specific limitation is made thereto.

[0074] In this embodiment, referring to Figures 8a - 8c , before the connecting member 215 disconnects from the connecting ring 17, one end of the aortic valve stent 10 will be restricted and in a contracted state, so that the first housing 211 can be moved in the reverse direction to recover the aortic valve stent 10. Referring to Figure 8d , after the connecting member 215 disconnects from the connecting ring 17, the aortic valve stent 10 will be completely released.

[0075] In some embodiments, the first accommodating cavity 213 of the first housing 211 can be large enough such that the reverse movement of the first housing 211 can recover the entire aortic valve stent 10 including the second positioning portion 14 into the first accommodating cavity 213. In some other embodiments, a connecting ring can also be provided at the other end of the stent body 11. Similarly, a connecting member is also provided at the other end of the loading portion 21 to recover the already released second positioning portion 14 and the lower half of the stent body 11.

[0076] As described above, it may be necessary to adjust the coaxiality between the aortic valve stent 10 and the aorta before releasing the aortic valve stent 10. Although the adjustment can be performed by directly moving the operating portion 22, since the operating portion 22 is outside the body while the loading portion 21 is inside the body, it is difficult to directly adjust the angle of the loading portion 21 by moving the operating portion 22. Therefore, in some embodiments, the delivery device 20 may further include a rotating portion 24. Referring to Figure 10a and Figure 10b , the rotating portion 24 is disposed in the extending portion 23. The operating portion 22 can operate the rotating portion 24 to rotate, so as to change the orientation of the axis of the loading portion 21. For example, by operating the rotating portion 24 to rotate, the orientation of the axis of the loading portion 21 can be adjusted from the direction shown in Figure 10a to the direction shown in Figure 10b . Thus, the coaxiality between the aortic valve stent 10 and the aorta can be adjusted more conveniently.

[0077] In some embodiments, as described above, the aortic valve stent 10 may include a traction wire 15. The traction wire 15 can pass through the first positioning portion 13 and the second positioning portion 14. At this time, the operating portion 22 can also be configured to be able to operate the traction wire 15. For example, both ends of the traction wire 15 can be connected to the operating portion 22. The operating portion 22 can drive the traction wire 15 to move through a transmission structure to complete the traction. After the traction is completed, one end of the traction wire 15 can be released, and the other end of the traction wire 15 can be operated to pull the traction wire 15 out of the patient's body. The specific manner in which the operating portion 22 operates the traction wire 15 can refer to the operating manner of the loading portion 21 or the connecting member 215, or any suitable operating manner in the art, and this is not limited thereto.

[0078] In some embodiments, both ends of the traction wire 15 can pass through the operating portion 22, and the operator can directly pull both ends of the traction wire to perform the traction. After the traction is completed, the operator can pull one end of the traction wire 15 to pull the traction wire 15 out of the patient's body.

[0079] The present invention has been described in detail above in conjunction with embodiments, but the present invention is not limited thereto. Within the scope of knowledge possessed by those of ordinary skill in the art, various changes can be made without departing from the gist of the present invention. The content not described in detail in the present invention can all adopt the prior art.

[0080] In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiments or examples. Moreover, the specific features, structures, materials, or characteristics described may be combined in any one or more embodiments or examples in a suitable manner. In addition, without contradiction, those skilled in the art may combine and combine the different embodiments or examples described in this specification and the features of different embodiments or examples.

Claims

1. An aortic valve stent (10), comprising: A stent body (11), the stent body (11) having a contracted state and a deployed state, the stent body (11) being capable of being delivered in the contracted state and being switched to the deployed state after reaching the aortic valve; A valve (12) disposed inside the stent body (11); and A first positioning portion (13) and a second positioning portion (14) disposed outside the stent body (11), when the stent body (11) is in the deployed state, the first positioning portion (13) and the second positioning portion (14) can be respectively located on both sides of the leaflets of the aortic valve to fix the stent body (11) at the aortic valve; One end of the first positioning portion (13) away from the stent body (11) is bent towards the stent body (11) to form a first hook-shaped body (131), and one end of the second positioning portion (14) away from the stent body (11) is bent away from the stent body (11) to form a second hook-shaped body (141), the first hook-shaped body (131) and the second hook-shaped body (141) can cooperate with each other to clamp the leaflets of the aortic valve between the first positioning portion (13) and the second positioning portion (14); Further comprising: a traction wire (15), the traction wire (15) being capable of passing through the second hook-shaped body (141) and the first hook-shaped body (131), so that the traction wire (15) can traction the first hook-shaped body (131) to move towards the second hook-shaped body (141); The traction wire (15) is configured to be able to at least partially cut the leaflets of the aortic valve clamped between the first hook-shaped body (131) and the second hook-shaped body (141) during the process of traction the first hook-shaped body (131) towards the second hook-shaped body (141); A contraction ring (16) disposed in the middle of the stent body (11), when the stent body (11) is in the deployed state, the diameter of the middle part is smaller than the diameters of both ends; When the middle part of the stent body (11) is contracted by the contraction ring (16), it will further drive the aortic valve clamped by the first positioning portion (13) and the second positioning portion (14) away from the aortic wall.

2. The aortic valve stent (10) according to claim 1, wherein, The first positioning portion (13) and the second positioning portion (14) are arc-shaped.

3. The aortic valve stent (10) according to claim 1, wherein, When the stent body (11) is in the contracted state, the first positioning portion (13) is at least partially located outside the second positioning portion (14).

4. The aortic valve stent (10) according to claim 1, wherein, When the stent body (11) is in the contracted state, the first positioning portion (13) and the second positioning portion (14) are in a straight state.

5. The aortic valve stent (10) according to claim 1, wherein, A first thorn-shaped body (132) is formed at the end of the first hook-shaped body (131); and / or A second thorn-shaped body (142) is formed at the end of the second hook-shaped body (141), the first thorn-shaped body (132) and the second thorn-shaped body (142) can at least partially penetrate into the leaflets of the aortic valve.

6. The aortic valve stent (10) according to claim 1, wherein, A matte layer is provided at the positions where the first positioning portion (13) and the second positioning portion (14) contact the leaflets of the aortic valve.

7. The aortic valve stent (10) according to claim 1, wherein, The stent body (11) includes: a contraction section (111) and expansion sections (112) provided at both ends of the contraction section (111), wherein the inner diameter of the expansion section (112) gradually increases in a direction away from the contraction section (111); the first positioning portion (13) is provided on the contraction section (111).

8. The aortic valve stent according to claim 1, wherein, The material of the contraction ring (16) is a flexible material.

9. The aortic valve stent (10) according to claim 1, wherein, The contraction ring (16) is provided on a side of the first positioning portion (13) away from the second positioning portion (14).

10. The aortic valve stent (10) according to claim 1, further comprising: A connection ring (17) provided at one end of the stent body (11), and the connection ring (17) is used to load the stent body (11) onto a delivery device.

11. A system for delivering an aortic valve stent, comprising: The aortic valve stent (10) according to any one of claims 1-10, and A delivery device (20), the aortic valve stent (10) can be loaded onto the delivery device (20) when the stent body (11) is in a contracted state, and the delivery device (20) can transport the aortic valve stent (10) to the aortic valve and release the aortic valve stent (10) to switch the stent body (11) to an expanded state.

12. The system according to claim 11, wherein, The delivery device (20) includes: A loading portion (21) for loading the aortic valve stent (10); An operation portion (22) for operating the movement of the loading portion (21) to load or release the aortic valve stent (10); and An extension portion (23), and the extension portion (23) is connected between the loading portion (21) and the operation portion (22).

13. The system according to claim 12, wherein, The loading portion (21) includes a first housing (211) and a second housing (212), and the first housing (211) and the second housing (212) can move respectively under the operation of the operation portion (22).

14. The system according to claim 13, wherein, The first housing (211) forms a first accommodation cavity (213), and the second housing (212) forms a second accommodation cavity (214). When the aortic valve stent (10) is loaded onto the loading portion (21), the first positioning portion (13) is located in the first accommodation cavity (213), and the second positioning portion (14) is located in the second accommodation cavity (214).

15. The system according to claim 14, wherein When the aortic valve stent (10) is loaded onto the loading portion (21), the second housing (212) is partially located between the first positioning portion (13) and the second positioning portion (14).

16. The system according to claim 12, wherein, The loading portion (21) further includes: A connecting member (215), and the connecting member (215) can move under the operation of the operation portion (22) to connect or disconnect from the connection ring (17) of the aortic valve stent (10).

17. The system according to claim 12, wherein, The conveying device (20) further includes a rotating part (24) disposed in the extension part (23), and the operating part (22) is further configured to operate the rotating part (24) to rotate, so as to change the orientation of the axis of the loading part (21) after the loading part (21) is conveyed to the aortic valve.

18. The system according to claim 12, wherein, The operating part (22) is further configured to operate the traction wire (15) of the aortic valve stent (10).

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