Aortic valve

Abstract

The invention relates to an aortic valve and a conveying system.The aortic valve comprises a valve body and a limiting rod, one end of the limiting rod is connected with the valve body, the other end of the limiting rod extends in the direction away from the valve body to form a free end, and after the aortic valve is released, the limiting rod is connected with the valve body to form the free end; the limiting rod can abut against the native valve leaflet in the body so as to limit the aortic valve from moving towards the ventricle. And through the arrangement of the limiting rod, the accuracy of the aortic valve during releasing and the use safety can be improved, and the risk of an operation is reduced.

Description

Technical Field

[0001] The present invention relates to the field of interventional medicine, and particularly to an aortic valve implanted by an interventional method. Background Art

[0002] Heart valve disease is a very common heart disorder. Among them, valvular damage caused by rheumatic fever is one of the most common causes. Valvular lesions caused by senile valvular disease and coronary heart disease after myocardial infarction are also becoming more and more common. The four valves of the human body are respectively called the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. If these valves are diseased, the types of lesions are usually stenosis or insufficiency, which will prevent normal blood flow, increase the corresponding heart burden, thereby causing damage to the normal function of the heart, leading to heart failure and changes in the functions of multiple organs of the body. These valvular lesions not only endanger life safety and affect the quality of life, but also bring heavy burdens and pressures to families and society. Among the above-mentioned lesions, the proportion of aortic valve lesions is the highest and is very dangerous. Severe cases may even present angina pectoris, left heart failure, sudden death. Acute cases can quickly present symptoms and even die within a short period of time.

[0003] In the existing aortic valve products, if the valve release position is inaccurate during the operation and the valve prosthesis is not stably fixed and is prone to displacement, it will affect the function of the valve prosthesis. Moreover, after the existing aortic valve products are released, they are prone to jump and displace or be displaced by blood impact, thereby affecting the function of the valve prosthesis, increasing the difficulty of doctor operation, and increasing the surgical risk. Summary of the Invention

[0004] To overcome the problems existing in the prior art, the present invention provides an aortic valve.

[0005] The solution of the present invention to solve the technical problem is to provide an aortic valve that can be delivered to the diseased position through an interventional delivery system. The aortic valve includes a valve body and a limiting rod. One end of the limiting rod is connected to the valve body, and the other end of the limiting rod extends away from the valve body to form a free end. When the aortic valve is released, the limiting rod can abut against the native valve leaf in the body.

[0006] In some embodiments of the present invention, the aortic valve further includes a connecting structure. The connecting structure includes a connecting head and a connecting rod. The proximal end of the connecting rod is received in the connecting head, the distal end of the connecting rod is connected to the limiting rod, a limiting portion is provided at the proximal end of the connecting rod, a through groove is provided at the distal end of the connecting head, the proximal end of the connecting rod passes through the through groove and the limiting portion is received in the connecting head.

[0007] In some embodiments of the present invention, the connecting rod, the limiting rod and the valve body are integrally formed. The connecting rod includes a straight rod structure, and the limiting rod includes a straight rod structure. The tangent direction of the proximal end of the connecting rod is set at an obtuse angle with the axial direction of the valve body, and the tangent direction of the distal end of the connecting rod is set at an obtuse angle with the axial direction of the valve body.

[0008] In some embodiments of the present invention, the connecting rod, the limiting rod and the valve body are integrally formed. The connecting rod includes a curved structure with a smooth transition bend. The tangent direction of the proximal end of the connecting rod is set at an acute angle or parallel to the axial direction of the valve body, and the tangent direction of the distal end of the connecting rod is set at an acute angle or parallel to the axial direction of the valve body.

[0009] In some embodiments of the present invention, there is an arc transition connection between the connecting rod and the limiting rod and / or the distal end of the limiting rod is bent towards the valve body to form an anti-scratch structure; a connecting portion is provided at the proximal end of the connecting head, and a mating portion is provided at the distal end of the delivery cable. The connecting portion and the mating portion are detachably connected.

[0010] In some embodiments of the present invention, the limiting rod and the valve body are integrally formed. One end of the limiting rod is fixedly connected to the valve body, and the other end of the limiting rod is a free end. The distal end of the connecting rod is detachably connected to the free end of the limiting rod.

[0011] In some embodiments of the present invention, the limiting rod extends in an arc shape away from the valve body. A clamping structure is provided at the distal end of the connecting rod. When the aortic valve is compressed and loaded in the delivery system, the clamping structure cooperates with the limiting rod. When the aortic valve is deployed and released, the clamping structure is disengaged from the limiting rod.

[0012] In some embodiments of the present invention, the clamping structure includes a first arc segment, a first straight segment, a second arc segment and a second straight segment. One end of the first arc segment is connected to the distal end of the connecting rod, the other end of the first arc segment is connected to one end of the first straight segment, the other end of the first straight segment is connected to one end of the second arc segment, and the other end of the second arc segment is connected to one end of the second straight segment; the first arc segment bends towards the distal end, and the second arc segment bends towards the proximal end.

[0013] In some embodiments of the present invention, the radians of the first arc segment and the second arc segment are less than or equal to π, and when the aortic valve is compressed and loaded in the delivery system, the distal end of the limit rod is located in the first arc segment, and when the aortic valve gradually expands until it is fully expanded, the distal end of the limit rod passes through the first arc segment, the first straight line segment, the second arc segment, and the second straight line segment in sequence until the limit rod is disengaged from the locking structure.

[0014] The solution to the technical problem of the present invention is to provide a delivery system for delivering the aortic valve as described in any of the above items to the lesion site, the delivery system comprising a sheath and a delivery cable, the aortic valve can be compressed and loaded in the sheath, the proximal end of the connector is connected to the distal end of the delivery cable; the sheath can move proximally to release the aortic valve.

[0015] Compared with the prior art, the aortic valve and delivery system of the present invention have the following advantages: when the aortic valve is released at the location of the aortic valve lesion, the blood in the ascending aorta will press back against the outflow end of the aortic valve, causing it to shift toward the left ventricle, and the limiting rod will resist the native valve leaflets in the body, thereby preventing the aortic valve from being pressed by the blood and moving toward the left ventricle, thereby improving the safety of the aortic valve and reducing the risk of surgery. When the aortic valve is released at an incorrect or unsatisfactory position, the aortic valve can be recovered into the sheath tube through the setting of the connecting structure, and repositioned and released, thereby improving the accuracy of the positioning and release of the aortic valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 It is a perspective structural diagram of the aortic valve and the delivery system provided by the first embodiment of the present invention.

[0017] Figure 2 It is a schematic diagram of the aortic valve provided by the first embodiment of the present invention being released at the lesion site.

[0018] Figure 3 It is a schematic cross-sectional structure diagram of a delivery cable and a connector of an aortic valve and a delivery system provided in the first embodiment of the present invention.

[0019] Figure 4 yes Figure 3 Enlarged view of point A in the middle.

[0020] Figure 5 It is a schematic diagram of the three-dimensional structure of the aortic valve provided by the first embodiment of the present invention.

[0021] Figure 6 It is a schematic diagram of the three-dimensional structure of the connecting rod of the aortic valve provided by the first embodiment of the present invention.

[0022] Figure 7 It is a schematic perspective view of the aortic valve after release of the aortic valve and delivery system provided by the first embodiment of the present invention.

[0023] Figure 8 It is a schematic perspective view of the process of retrieving the aortic valve of the aortic valve and delivery system provided by the first embodiment of the present invention.

[0024] Figure 9 It is a schematic three-dimensional view of an example of the deformation of the aortic valve provided by the first embodiment of the present invention.

[0025] Figure 10 It is an enlarged schematic view of the limiting rod and anti-scratch structure of the aortic valve provided by the first embodiment of the present invention.

[0026] Figure 11 It is a schematic perspective view of the complete release of the aortic valve and delivery system provided by the second embodiment of the present invention.

[0027] Figure 12 It is a schematic three-dimensional view of the aortic valve and delivery system when the aortic valve is not fully released provided by the second embodiment of the present invention.

[0028] Figure 13 is Figure 12 The enlarged view at position B in

[0029] Figure 14 It is a schematic three-dimensional view of the aortic valve provided by the third embodiment of the present invention.

[0030] Figure 15 is Figure 14 The enlarged view at position C in

[0031] Figure 16 It is an enlarged schematic view of the limiting rod, connecting piece and valve body of the aortic valve provided by the third embodiment of the present invention.

[0032] Figure 17 It is another enlarged schematic view of the limiting rod, connecting piece and valve body of the aortic valve provided by the third embodiment of the present invention.

[0033] Description of the attached drawing reference numerals: 100, aortic valve; 200, delivery system; 21, sheath tube; 22, delivery cable; 11, valve body; 12, limiting rod; 13, connecting structure; 131, connecting head; 132, connecting rod; 1321, limiting part; 1311, through groove; 111, mating part; 1322, connecting section; 1323, first arc section; 1324, second arc section; 121, anti-scratch structure; 300, aortic valve; 31, valve body; 32, limiting rod; 33, connecting structure; 331, connecting head; 332, connecting rod; 3321, clamping structure; 3322, first circular arc section; 3323, first straight section; 3324, second circular arc section; 3325, second straight section; 400, aortic valve; 44, connecting piece; 42, limiting rod; 43, connecting structure; 41, valve body; 432, connecting rod; 4321, first channel; 4322, second channel; 441, wire body; 442, ferrule structure. Detailed implementation mode

[0034] The exemplary embodiments of the present invention will be described in more detail below with reference to the attached drawings. Although the exemplary embodiments of the present invention are shown in the attached drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided to enable a more thorough understanding of the present invention and to fully convey the scope of the present invention to those skilled in the art.

[0035] It should be understood that the terms used herein are only for the purpose of describing specific exemplary embodiments and are not intended to be limiting. Unless otherwise clearly specified in the context, the singular forms "a", "an" and "the" as used herein may also include the plural forms. The terms "include", "comprise", "contain" and "have" are inclusive and thus specify the presence of the stated features, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring them to be executed in the specific order described or illustrated, unless the execution order is clearly specified. It should also be understood that additional or alternative steps may be used.

[0036] Although the terms first, second, third, etc. may be used herein to describe multiple elements, components, regions, layers, and / or sections, these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or section from another region, layer, or section. Unless the context clearly indicates otherwise, terms such as "first", "second", and other numerical terms do not imply an order or sequence when used in the text. Thus, the first element, component, region, layer, or section discussed below may be referred to as the second element, component, region, layer, or section without departing from the teachings of the exemplary embodiments.

[0037] For ease of description, spatial relative relationship terms may be used herein to describe the relationship of one element or feature shown in the figure to another element or feature, such as "inner", "outer", "inside", "outside", "below", "beneath", "above", "over", etc. Such spatial relative relationship terms are intended to include different orientations of the device in use or operation other than the orientation depicted in the figure. For example, if the device in the figure is flipped, an element described as "below" or "beneath" another element or feature will then be oriented as "above" or "over" the other element or feature. Thus, the exemplary term "below" can include both upward and downward orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used in the text are to be interpreted accordingly.

[0038] To more clearly describe the structure of the present application, the terms "proximal" and "distal" are defined herein as terms commonly used in the field of interventional medicine. Specifically, "distal" refers to the end away from the operator during a surgical procedure, "proximal" refers to the end close to the operator during a surgical procedure, "axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial" direction.

[0039] Please refer to Figure 1 and Figure 2, the first embodiment of the present invention provides an aortic valve 100 and a delivery system 200. The aortic valve 100 is a transcatheter interventional self-expanding aortic valve for treating aortic valve lesions, and the delivery system 200 is used to deliver the aortic valve 100 to the lesion site. The delivery system 200 includes a sheath 21 and a delivery cable 22. Before the aortic valve 100 enters the human body, the aortic valve 100 needs to be compressed and loaded into the sheath 21 of the delivery system 200, and the proximal end of the aortic valve 100 is connected to the delivery cable 22 of the delivery system 200. When the sheath 21 enters the human body and moves to the lesion site, the sheath 21 can be retracted, that is, the sheath 21 is moved proximally, so as to release the aortic valve 100 loaded in the sheath 21 at the lesion site. Subsequently, the delivery cable 22 is disengaged from the aortic valve 100, and the delivery system 200 can be withdrawn from the body.

[0040] Specifically, the aortic valve 100 includes a valve body 11, a limiting rod 12, and a connecting structure 13. The valve body 11, the limiting rod 12, and the connecting structure 13 are integrally formed. The connecting structure 13 includes a connecting head 131 and a connecting rod 132. The proximal end of the connecting head 131 is detachably connected to the distal end of the delivery cable 22. The proximal end of the connecting rod 132 is received in the connecting head 131. The distal end of the connecting rod 132 is fixedly connected to one end of the limiting rod 12. The other end of the limiting rod 12 extends away from the valve body 11 to form a free end. The valve body 11 is fixedly connected to the distal end of the connecting rod 132. When the aortic valve 100 is released at the lesion site, the limiting rod 12 can abut against the native leaflets in the body to limit the movement of the aortic valve 100 in the ventricular direction due to the influence of blood flow, such as Figure 2As shown. It should be noted that one end where blood flows into the aortic valve 100 is the inflow end of the aortic valve 100, and one end where blood flows out of the aortic valve 100 is the outflow end of the aortic valve 100. The outflow end of the aortic valve 100 is close to the ascending aorta, and the inflow end of the aortic valve 100 is close to the left ventricle. When the aortic valve 100 is released at the aortic valve lesion site, the blood in the ascending aorta will press back against the outflow end of the aortic valve 100, causing it to shift in the direction of the left ventricle. The limiting rod 12 abuts against the native leaflet in the body, thereby preventing the aortic valve 100 from being displaced in the direction of the left ventricle by the blood pressure, so as to improve the safety of using the aortic valve 100 and reduce the surgical risk. In the first embodiment of the present invention, the connection head 131 and the delivery cable 22 are threadedly connected. After the aortic valve 100 is released, the delivery cable 22 can be rotated so that the connection head 131 and the delivery cable 22 lose their cooperation, and then the delivery system 200 can be withdrawn from the human body.

[0041] In other specific embodiments of the present invention, one end of the limiting rod 12 can be fixedly connected to the valve body 11, and the distal end of the connecting rod 132 can be fixedly connected to the valve body 11 or fixedly connected to the connecting rod 132. That is, the connection relationship between the valve body 11, the connection structure 13, and the limiting rod 12 may not be limited, as long as the valve body 11, the connection structure 13, and the limiting rod 12 are integrally formed.

[0042] Please refer to Figure 2 - Figure 4, a limiting portion 1321 is provided at the proximal end of the connecting rod 132, and a through groove 1311 is provided at the distal end of the connecting head 131. The proximal end of the connecting rod 132 passes through the through groove 1311 and the limiting portion 1321 is received in the connecting head 131. In the first embodiment of the present invention, the limiting portion 1321 is a rod-shaped structure perpendicular to the length direction of the connecting rod 132, and the length L in the length direction of the limiting portion 1321 is greater than the maximum width D of the through groove 1311 to ensure that the limiting portion 1321 cannot be separated from the connecting head 131, thereby ensuring a stable connection between the connecting rod 132 and the connecting head 131. In the first embodiment of the present invention, the number of the connecting rods 132 and the through grooves 1311 is multiple, and the number of the connecting rods 132 is the same as that of the through grooves 1311. One end of the multiple connecting rods 132 provided with the limiting portion 1321 is received in the connecting head 131, and the multiple connecting rods 132 and the through grooves 1311 are uniformly arranged in the circumferential direction of the connecting head 131, and one limiting portion 1321 is correspondingly received in the connecting head 131 after passing through one through groove 1311. It should be noted that when the aortic valve 100 is released, the valve body 11 is released from the compressed state to the unfolded state, and the distal end of the connecting rod 132 will move along with the unfolding of the valve body 11, and the proximal end of the connecting rod 132 is received in the connecting head 131 to ensure the connection between the connecting rod 132 and the connecting head 131. Therefore, during the release of the aortic valve 100, the connecting rod 132 will undergo a certain deformation to adapt to the unfolding and compression of the valve body 11. Therefore, the connecting rod 132 needs to have a certain supportability and elasticity. In the first embodiment of the present invention, the connecting rod 132 is made of nitinol alloy, that is, the valve body 11, the limiting rod 12 and the connecting structure 13 are integrally cut from a nitinol tube.

[0043] Further, please refer to Figure 5 and Figure 6, a plurality of mating portions 111 are circumferentially and uniformly arranged at one end of the valve body 11 close to the connecting rod 132. The number of the mating portions 111 is the same as that of the connecting rod 132, and the distal ends of the connecting rod 132 are arranged in one-to-one correspondence with the mating portions 111. In the first embodiment of the present invention, the valve body 11 is a tubular structure formed by cutting a metal tube and having a plurality of diamond grid units, and a plurality of diamond grid units on the circumference of one end of the valve body 11 close to the connecting rod 132 are the plurality of mating portions 111, that is, a plurality of grid units at the outflow end of the valve body 11 are the plurality of mating portions 111. The number of the connecting rod 132 is the same as the number of grid units at the outflow end of the valve body 11, that is, one connecting rod 132 is correspondingly connected to one grid unit at the outflow end of the valve body 11. The connecting rod 132 can be directly connected to the grid unit, and the limiting rod 12 is also connected to the grid unit. Or the connecting rod 132 is connected to the limiting rod 12, and the limiting rod 12 is connected to the grid unit. The connecting rod 132 is a bent structure with a smooth transition bend. Specifically, the connecting rod 132 includes a connecting section 1322, a first arc section 1323 and a second arc section 1324. A limiting portion 1321 is arranged at the proximal end of the connecting section 1322 and is connected to the connecting head 131. The distal end of the connecting section 1322 is connected to the proximal end of the first arc section 1323. The distal end of the first arc section 1323 is connected to the proximal end of the second arc section 1324. The distal end of the second arc section 1324 is connected to the limiting rod 12 or to the mating portion 111 of the valve body 11. The connecting section 1322 is a straight rod structure, and the tangent direction of the proximal end of the connecting section 1322 is parallel or at an acute angle to the axial direction of the valve body 11. The first arc section 1323 and the second arc section 1324 are arc structures. The first arc section 1323 extends and bends in the direction of the outside of the connecting structure 13, and the second arc section 1324 extends and bends in the direction of the inside of the connecting structure 13, and the tangent direction of the distal end of the second arc section 1324 is at an acute angle or parallel to the valve body 11. The connecting section 1322, the first arc section 1323 and the second arc section 1324 together form a bent structure with a smooth transition bend.

[0044] Through the setting of the connection structure 13, the aortic valve 100 can be retracted into the sheath 21 for repositioning and release, thereby improving the accuracy of the positioning and release of the aortic valve 100. By making the number of the connecting rods 132 consistent with the number of the mating parts 111 at the outflow end of the valve body 11, and each connecting rod 132 is correspondingly connected to one of the mating parts 111 at the outflow end of the valve body 11, it can ensure that the aortic valve 100 can be smoothly retracted into the sheath 21. At the same time, by setting the connecting rod 132 as a curved structure with a smooth transition bend, it can ensure that the retraction process of the aortic valve 100 is smoother. Specifically, when the aortic valve 100 needs to be released, the sheath 21 is retracted, and then the aortic valve 100 is released, such as Figure 7As shown. If the release position of the aortic valve 100 is not ideal enough, the sheath 21 can be moved towards the aortic valve 100 until the sheath 21 moves to the position of the connecting rod 132. At this time, since the connecting section 1322 is a straight rod structure and the connecting section 1322 is parallel or arranged at an acute angle to the axial direction of the valve body 11, the sheath 21 can easily receive the connecting section 1322 into the sheath 21. Then, continue to move the sheath 21 in the direction of the first arc section 1323. Since the first arc section 1323 extends towards the outside of the connecting structure 13 and is smoothly transitioned and bent, when the first arc section 1323 is retracted into the sheath 21, it will be retracted into the sheath 21 more smoothly. At the same time, when the first arc section 1323 is retracted into the sheath 21, it needs to deform so that the first arc section 1323 adapts to the shape of the sheath 21 and is then received in the sheath 21. And extending the first arc section 1323 towards the outside of the connecting structure 13 and smoothly transitioning and bending can reduce the resistance that needs to be overcome when the first arc section 1323 deforms, thereby further ensuring that the first arc section 1323 can be smoothly and successfully retracted into the sheath 23. Then, continue to move the sheath 21 in the direction of the second arc section 1324. Since the second arc section 1324 extends towards the inside of the connecting structure 13 and is smoothly transitioned and bent, and the tangent direction of the distal end of the second arc section 1324 is arranged at an acute or parallel angle to the axial direction of the valve body 11. Therefore, the second arc section 1324 can also be smoothly and successfully retracted into the sheath 21, reducing the resistance when the second arc section 1324 is retracted into the sheath 21. At the same time, the setting of the second arc section 1324 can also prevent the aortic valve 100 from scratching the blood vessel wall. After the entire connecting structure 13 is retracted into the sheath 21, the outflow end of the valve body 11 connected to the connecting structure 13 will be driven by the connecting structure 13 and compressed. At this time, moving the sheath 21 towards the valve body 11 can retract the end of the valve body 11 connected to the connecting structure 13 into the sheath 21, such as Figure 8As shown. At this time, continue to move the sheath tube 21 in the direction of the valve body 11, and the valve body 11 will conform to the size of the sheath tube 21 and then contract into the sheath tube 21. By making the number of the connecting rods 132 consistent with the number of the engaging portions 111 at the outflow end of the valve body 11, and connecting one connecting rod 132 to one engaging portion 111 at the outflow end of the valve body 11, it can be ensured that when the valve body 11 is driven by the connecting rods 132 and compressed, the outflow end of the valve body 11 can be uniformly and completely compressed, so as to ensure that the outflow end of the valve body 11 can be retracted into the sheath tube 21. If one of the engaging portions 111 is not connected to the connecting rod 132, this engaging portion 111 will not be driven by the connecting rod 132 and compressed, and this engaging portion 111 may abut against the distal end of the sheath tube 21 due to lack of compression, resulting in the valve body 11 being unable to be retracted into the sheath tube 21.

[0045] It should be noted that in the first embodiment of the present invention, the connecting rod 132 is a bent structure formed by pre-bending and heat setting, and the connecting rod 132 is made of nitinol material because the connecting rod 132 made of nitinol material has good resilience. When the connecting rod 132 is compressed and deformed, the connecting rod 132 can still rebound into the shape after being pre-shaped when released.

[0046] In other specific embodiments of the present invention, in order to reduce the manufacturing cost and manufacturing difficulty of the aortic valve 100, etc., the connecting rod 132 and the limiting rod 12 may also be straight rod structures, such as Figure 9 As shown. At the same time, in order to ensure the size of the aortic valve 100 in the length direction and avoid the situation that the length of the aortic valve 100 in the length direction is too long and easily scratches the blood vessel wall or causes the aortic valve 100 to be unable to be released, etc., the tangent direction of the proximal end of the connecting rod 132 and the axial direction of the valve body 11 can be set at an obtuse angle, and the tangent direction of the distal end of the connecting rod 132 and the axial direction of the valve body 11 can be set at an obtuse angle, so that the aortic valve 100 has a smaller size in the length direction.

[0047] Please refer to Figure 10, to further prevent the aortic valve 100 from scratching the blood vessel wall, the connecting rod 132 and the limiting rod 12 can be connected with an arc transition, and the distal end of the limiting rod 12 is bent towards the direction close to the valve body 11 to form an anti-scratch structure 121. The aortic valve 100 further includes a skirt cloth and valve leaflets (not shown in the figure). The skirt cloth is arranged on the inner and outer sides of the valve body 11. The number of valve leaflets is three, and the three valve leaflets are evenly sutured on the skirt cloth on the inner side of the valve body 11 through sutures. The arrangement of the skirt cloth and the valve leaflets is prior art and will not be described in detail here.

[0048] Please refer to Figure 11 - Figure 13 , the second embodiment of the present invention provides an aortic valve 300, and the delivery system of the second embodiment can directly adopt the delivery system 200 of the first embodiment. The main difference between the aortic valve 300 and the aortic valve 100 of the first embodiment is that: the limiting rod 32 and the valve body 31 are integrally formed, one end of the limiting rod 32 is fixedly connected to the valve body 31, the other end of the limiting rod 32 is a free end, and the distal end of the connecting rod 332 is detachably connected to the free end of the limiting rod 32. The limiting rod 32 extends in an arc shape away from the valve body 31, and a clamping structure 3321 is arranged at the distal end of the connecting rod 332. When the aortic valve 300 is compressed and loaded in the delivery system 200, the clamping structure 3321 cooperates with the limiting rod 32. When the aortic valve 300 is deployed and released at the diseased position, the clamping structure 3321 is disengaged from the limiting rod 32.

[0049] Specifically, the card slot structure 3321 includes a first arc segment 3322, a first straight segment 3323, a second arc segment 3324, and a second straight segment 3325. One end of the first arc segment 3322 is connected to the distal end of the connecting rod 332, the other end of the first arc segment 3322 is connected to one end of the first straight segment 3323, the other end of the first straight segment 3323 is connected to one end of the second arc segment 3324, and the other end of the second arc segment 3324 is connected to one end of the second straight segment 3325. At the same time, the first arc segment 3322 bends towards the distal end, and the second arc segment 3324 bends towards the proximal end. The radian of the first arc segment 3322 and the second arc segment 3324 is less than or equal to π. When the aortic valve 100 is compressed and loaded in the delivery system 200, the distal end of the limiting rod 32 is located within the first arc segment 3322. At this time, the connecting rod 332 cooperates with the limiting rod 32, and further enables the connection structure 33 to cooperate with the valve body 31. When the aortic valve 100 is not fully released, the connecting rod 332 still maintains cooperation with the limiting rod 32. When the aortic valve 100 is fully deployed, the connecting rod 332 and the limiting rod 32 are disengaged from each other.

[0050] Further, the radian of the first arc segment 3322 and the second arc segment 3324 is set to be less than or equal to π, thereby ensuring that the limiting rod 32 can disengage from the first arc segment 3322 and the second arc segment 3324, avoiding the situation where the radian of the first arc segment 3322 is too large and the limiting rod 32 cannot disengage from the first arc segment 3322, and avoiding the situation where the radian of the second arc segment 3324 is too large and the limiting rod 32 cannot slide past the second arc segment 3324, resulting in the limiting rod 32 being unable to disengage from the clamping structure 3321. The process of disengagement between the connecting rod 332 and the limiting rod 32 is as follows: when the aortic valve 300 starts to be released and deployed, the inflow segment end of the valve body 31 starts to be deployed first, and when the deployment position of the valve body 31 reaches the position of the limiting rod 32, since the connecting rod 332 is outside the limiting rod 32, the connecting rod 332 starts to be deployed earlier than the limiting rod 32. Since the proximal end of the connecting rod 332 is received in the connecting head 331, during the release process, the distal end of the connecting rod 332 will move in a direction away from the central axis of the valve body 31. And since the connecting rod 332 is a rod-shaped structure with a fixed length, when the connecting rod 332 moves, a certain displacement will be generated in the axial direction of the valve body 31 at its distal end, that is, during the release process, the clamping structure 3321 of the connecting rod 332 will move axially towards the proximal end relative to the limiting rod 32. At the same time, when releasing the limiting rod 32 and the connecting rod 332, the delivery steel cable 22 can be retracted simultaneously, so that the delivery steel cable 22 is retracted simultaneously with the sheath 21, thereby driving the connecting rod 332 to move axially in a direction away from the valve body 31. Therefore, based on the movement of the distal end of the connecting rod 332 and the axial displacement, the distal end of the limiting rod 32 will sequentially pass through the first arc segment 3322, the first straight segment 3323, the second arc segment 3324, and the second straight segment 3325, and finally the limiting rod 32 disengages from the clamping structure 3321. And since the connecting structure 3321 will move axially towards the proximal end relative to the limiting rod 32, when the aortic valve 300 is fully released, a relative movement occurs axially between the limiting rod 32 and the clamping structure 3321, thereby preventing the limiting rod 32 and the clamping structure 3321 from re - engaging due to the impact of blood flow or the pulsation of blood vessels, and thus ensuring that the limiting rod 32 and the clamping structure 3321 can be completely disengaged. During the entire deployment process of the valve body 31, the limiting rod 32 has not completely disengaged from the clamping structure 3321, so the limiting rod 32 and the clamping structure 3321 are still in a cooperating state.Therefore, before the valve body 31 is fully released and deployed, by moving the sheath 21 in the direction of the connecting rod 332, the connecting structure 33 can be retracted into the sheath 21, and then the valve body 31 can be retracted into the sheath 21. Therefore, for the aortic valve 300 of the second embodiment of the present invention, if it is found that the release position is not ideal during the release process, the aortic valve 300 can also be retracted into the sheath 21, and then the aortic valve 300 can be repositioned and released.

[0051] It should be noted that since the connecting rod 332 is deployed earlier than the limiting rod 32, it can be ensured that the connecting rod 332 and the limiting rod 32 can be separated, so as to avoid the situation where the limiting rod 32 is deployed first and continuously abuts against the first arc segment 3322, resulting in the inability of the connecting rod 332 and the limiting rod 32 to be separated. At the same time, to further ensure the smooth separation between the connecting rod 332 and the limiting rod 32, the connecting rod 332 can be made of a material with stronger elasticity, that is, the elasticity of the connecting rod 332 is stronger than that of the limiting rod 32. For example, the connecting rod 332 is made of a thicker nickel-titanium alloy material, and the limiting rod 32 is made of a thinner stainless steel material. When the connecting rod 332 and the limiting rod 32 are compressed in the sheath 21, the connecting rod 332 has greater elastic potential energy. When the connecting rod 332 is released, the connecting rod 332 can be quickly deployed and released, and the deployment and release speed of the connecting rod 332 is greater than that of the limiting rod 32, thereby ensuring that the connecting rod 332 can be separated from the limiting rod 32.

[0052] Furthermore, since the function of the limiting rod 32 is to abut against the native leaflet to prevent the aortic valve 300 from rushing into the left ventricle. And the impact force on the aortic valve 300 will not be too large, so the supporting force required for the limiting rod 32 does not need to be too strong. Therefore, the limiting rod 32 can be set to have weak support and strong elasticity, so that during the process of the limiting rod 32 separating from the clamping structure 3321, the limiting rod 32 can generate a certain deformation to further ensure that the limiting rod 32 can be separated from the clamping structure 3321.

[0053] It should be noted that since the limiting rod 32 is arranged outside the valve body 31, the distal end of the connecting rod 332 necessarily needs to extend outside the valve body 31, so as to ensure that the clamping structure 3321 can cooperate with the limiting rod 32. Therefore, when the connecting structure 33 is retracted into the sheath 21, it is necessary to first move the connecting structure 33 proximally to make it away from the valve body 31, and then move the sheath 21 in the direction of the connecting structure 33 to retract the connecting structure 33 into the sheath 21. If the connecting structure 33 is not first moved proximally and the sheath 21 is directly moved in the direction of the connecting structure 33, it may cause the distal end of the connecting rod 332 to be compressed and touch the valve body 31 when the connecting structure 33 is retracted into the sheath 21, resulting in displacement of the valve body 31. After the aortic valve 100 is released and the limiting rod 32 abuts against the native leaflet, the connecting structure 33 has no other function at this time and remaining in the body may exacerbate the inflammation in the body. Therefore, in the aortic valve 300 of the second embodiment of the present invention, by providing the clamping structure 3321, the connecting structure 33 and the limiting rod 32 are detachably matched, so that the connecting structure 33 can be separated from the valve body 31 and the limiting rod 32. Further, after the aortic valve 300 is released, the limiting rod 32 can remain at the aortic lesion site to abut against the native leaflet and prevent the aortic valve 300 from being washed into the left ventricle by the blood flow. At the same time, the connecting structure 33 can be separately retracted into the sheath 21 and withdrawn from the body together with the sheath 21. The foreign bodies implanted in the body can be reduced, the degree and duration of inflammation can be reduced, and the foreign body sensation brought by the aortic valve 300 can be alleviated.

[0054] Please refer to Figure 14 and Figure 15, the third embodiment of the present invention provides an aortic valve 400, and the delivery system of the third embodiment can directly adopt the delivery system 200 of the first embodiment. The main difference between the aortic valve 400 and the aortic valve 300 of the second embodiment is that: the aortic valve 400 further includes a connecting member 44, the limiting rod 42 and the connecting structure 43 are integrally formed, or the limiting rod 42 and the connecting structure 43 are fixedly connected by welding, gluing or other means, and the limiting rod 42 is disposed at the distal end of the connecting structure 43. Before the valve body 41 is completely released, the distal end of the connecting structure 43 is close to the valve body 41, and the free end of the limiting rod 42 extends away from the valve body 41 and protrudes outside the valve body 41. The connecting member 44 penetrates from the proximal end of the connecting structure 43, exits from the distal end of the connecting structure 43, and is detachably connected to the valve body 41. After the aortic valve 400 is completely released, the limiting rod 42 can abut against the native leaflets in the body to limit the movement of the aortic valve 400 in the direction of the ventricle. After the aortic valve 400 works stably, the connecting member 44 can be detached from the valve body 41, and the connecting structure 43 and the limiting rod 42 can be retracted into the delivery system 200, and then the connecting structure 43 and the limiting rod 42 can be withdrawn from the body. It should be noted that the leaflets of the aortic valve 400 only allow blood to flow from the inflow end to the outflow end of the aortic valve 400, that is, the leaflets of the aortic valve 400 only allow blood to flow from the left ventricle to the ascending aorta. When blood flows from the inflow end to the outflow end, the leaflets will open to allow blood to pass through. If the blood at the outflow end flows to the inflow end, the leaflets will always close to prevent blood from flowing from the outflow end to the inflow end. Therefore, when the aortic valve 400 is just released, the blood in the ascending aorta will press on the aortic valve 400 in the direction of the left ventricle. At this time, the leaflets are in a closed state, so the blood will press on the closed leaflets, which will cause the aortic valve 400 to move in the direction of the left ventricle after being pressed by the blood. Therefore, when the aortic valve 400 is just released, it is necessary for the limiting rod 42 to abut against the native leaflets to prevent the aortic valve 400 from moving in the direction of the left ventricle after being pressed by the blood. After the aortic valve 400 is released for a period of time, the blood will stably flow from the left ventricle to the ascending aorta under the influence of the aortic valve 400. At this time, the influence of the blood pressure in the ascending aorta on the aortic valve 400 will be greatly reduced, that is, at this time, the aortic valve 400 can be firmly fixed at the diseased position only by the radial supporting force of the valve body 41 itself. At this time, the connecting member 44 can be detached from the valve body 41, so that the limiting rod 42 and the connecting structure 43 can be retracted into the sheath 21 and withdrawn from the body along with the sheath 21.

[0055] Specifically, a first channel 4321 is provided on the outer side wall of the connecting rod 432. The first channel 4321 is arranged along the length direction of the connecting rod 432. The connecting member 44 enters from the proximal end of the first channel 4321, passes out from the distal end of the first channel 4321, and is connected to the valve body 11. The connecting member 44 can be a wire, such as a medical suture, etc. The proximal end of the wire is connected to the delivery system 200. The distal end of the wire enters the first channel 4321 of the connecting rod 432 through the inside of the delivery system 200 and passes out from the distal end of the first channel 4321, that is, the distal end of the wire passes out of the connecting rod 432 and is exposed outside the connecting rod 432. Subsequently, the distal end of the wire penetrates into the valve body 41 from the inner side or the outer side, passes out from the outer side or the inner side of the aortic valve and enters the connecting rod 432, and finally the distal end of the wire passes out from the proximal end of the connecting rod 432 and returns to the delivery system 200 again. The user can tighten both ends of the wire through the delivery system 200, so that the connection structure 43, the limiting rod 42 and the valve body 41 are kept connected. The wire can move relative to the connecting rod 432. When it is necessary to withdraw the connection structure 43 and the limiting rod 42 into the sheath 21, one end of the wire can be pulled to make the wire withdraw from between the valve body 41 and the connection structure 43, so that the valve body 41 is disconnected from the limiting rod 42 and the connection structure 43, and then the connection structure 43 and the limiting rod 42 can be retracted into the sheath 21 and withdrawn out of the body along with the sheath 21.

[0056] Please refer to Figure 15 and Figure 16 , in other specific embodiments of the present invention, the first channel 4321 can be replaced by a second channel 4322 provided inside the connecting rod 432. The second channel 4322 penetrates from the proximal end of the connecting rod 432 to the distal end of the connecting rod 432. The connecting member 44 enters from the proximal end of the second channel 4322, passes out from the distal end of the second channel 4322, and is connected to the valve body 41.

[0057] Please continue to refer to Figure 15 and Figure 16, in the third embodiment of the present invention, another connection method is also provided to connect the connector 44 with the valve body 41. Specifically, the distal end of the limiting rod 42 enters from the inside of the valve body 41, then extends from the inside to the outside of the valve body 41, passes through the valve body 41 and protrudes out of the outside of the valve body 41. A second channel 4322 is provided inside the connecting rod 432. The proximal end of the wire body is connected to the delivery system 200. The distal end of the wire body enters the second channel 4322 through the inside of the delivery system 200, passes out of the distal end of the second channel 4322, bypasses the limiting rod 42 and then enters the second channel 4322 again. Subsequently, the wire body passes out of the second channel 4322 and returns to the delivery system 200. When the user tightens both ends of the wire body, the wire body will tighten the limiting rod 42, making the limiting rod 42 closely adhere to the valve body 41, thereby making the connection between the connection structure 43, the limiting rod 42 and the valve body 41 closer and firmer. When it is necessary to disconnect the limiting rod 42, the connection structure 43 from the valve body 41, by pulling one end of the wire body, the wire body can be withdrawn into the sheath 21. At this time, the limiting rod 42 and the connection structure 43 are no longer restricted by the wire body, and the limiting rod 42 and the connection structure 43 can be retracted into the sheath 21. The limiting rod 42 can also be retracted into the sheath 21, which can further reduce foreign objects implanted in the body, further reduce the degree and duration of inflammation, and further reduce the foreign body sensation brought by the aortic valve 300.

[0058] Please refer to Figure 17In the third embodiment of the present invention, another connection method is provided to connect the connector 44 to the valve body 41. Specifically, the connector 44 includes a wire body 441 and a collar structure 442, and the proximal ends of the wire body 441 and the collar structure 442 are connected to the delivery system 200. The distal ends of the wire body 441 and the collar structure 442 enter the second channel 4322 through the inside of the delivery system 200 and pass out from the distal end of the second channel 4322. The distal end of the collar structure 442 passes through the inner side of the valve body 41 from the outer side of the valve body 41, and the distal end of the wire body 441 passes through the part of the collar structure 442 located on the inner side of the valve body from the inner side of the valve body 41. Then, the collar structure 442 and the wire body 441 are tightened, so that the distal end of the collar structure 442 is hung on the valve body 41, thereby achieving connection between the connecting structure 43, the limiting rod 42 and the valve body 41. When the connection structure 43, the limiting rod 42 and the valve body 41 need to lose the coordination, the collar structure 442 can be loosened first, and then the wire body 441 can be withdrawn into the second channel 4322, and then the collar structure 442 can be withdrawn into the second channel 4322, and then the connector 44 is no longer connected to the valve body 41, and the connection structure 43, the limiting rod 42 and the valve body 41 lose coordination. By connecting the connection structure 43, the limiting rod 42 and the valve body 41 in the above manner, it can be ensured that the resistance encountered by the connector 44 when withdrawing into the second channel 4322 is smaller, and the withdrawal of the connector 44 is smoother and more successful. It should be noted that the wire body 441 needs to have a certain degree of support, so the wire body 441 can be a wire body with a certain degree of support, such as stainless steel wire, nickel titanium wire, etc.

[0059] Furthermore, please combine Figure 14 - Figure 17, in the third embodiment of the present invention, the limiting rod 42 can enter from the inner side of the valve body 41, then extend from the inner side to the outer side of the valve body 41, and protrude out of the outer side of the valve body 41 after passing through the valve body 41. By arranging the limiting rod 42 in the above manner, the whole connecting structure 43 can be on the inner side of the valve body 41. When recovering the connecting structure 43 and the limiting rod 42, the sheath 21 is moved towards the connecting structure 43, so that the connecting structure 43 is compressed into the sheath 21. During the compression of the connecting structure 43, the connecting rod 432 and the limiting rod 42 will not touch the valve body 41. Therefore, by arranging the limiting rod 42 in the above manner, when recovering the connecting structure 43 and the limiting rod 42, only the sheath 21 needs to be moved. The distal end of the limiting rod 42 can also be arranged on the outer side of the valve body 41. By arranging the limiting rod 42 in the above manner, the connecting structure 43 needs to be moved towards the proximal end first to make it away from the valve body 41, and then the sheath 21 is moved towards the connecting structure 43 to compress and recover the connecting structure 43 into the sheath 21.

[0060] Compared with the prior art, an aortic valve and a delivery system of the present invention have the following advantages: for the aortic valve and the delivery system provided by the present invention, when the aortic valve is released at the position of the aortic valve lesion, the blood in the ascending aorta will press back against the outflow end of the aortic valve, causing it to shift towards the left ventricle, and the limiting rod abuts against the native leaflets in the body, thereby preventing the aortic valve from being pressed by the blood and moving towards the left ventricle, so as to improve the safety of using the aortic valve and reduce the risk of surgery. When the release position of the aortic valve is incorrect or unsatisfactory, through the arrangement of the connecting structure, the aortic valve can be recovered into the sheath for repositioning and release, thereby improving the accuracy of positioning and release of the aortic valve.

[0061] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. An aortic valve that can be delivered to a diseased location through an interventional delivery system, characterized in that: The aortic valve includes a valve body and a limiting rod. One end of the limiting rod is connected to the valve body, and the other end of the limiting rod extends away from the valve body to form a free end. When the aortic valve is released, the limiting rod can abut against the native leaflets in the body.

2. The aortic valve according to claim 1, characterized in that: The aortic valve further includes a connecting structure, which includes a connecting head and a connecting rod. The proximal end of the connecting rod is received in the connecting head, the distal end of the connecting rod is connected to the limiting rod, a limiting portion is provided at the proximal end of the connecting rod, a through groove is provided at the distal end of the connecting head, the proximal end of the connecting rod passes through the through groove and the limiting portion is received in the connecting head.

3. The aortic valve according to claim 2, wherein: The connecting rod, the limiting rod and the valve body are integrally formed. The connecting rod includes a straight rod structure, the limiting rod includes a straight rod structure, the tangent direction of the proximal end of the connecting rod is set at an obtuse angle to the axial direction of the valve body, and the tangent direction of the distal end of the connecting rod is set at an obtuse angle to the axial direction of the valve body.

4. The aortic valve according to claim 2, characterized in that: The connecting rod, the limiting rod and the valve body are integrally formed. The connecting rod includes a bent structure with a smooth transition bend. The tangent direction of the proximal end of the connecting rod is set at an acute angle or parallel to the axial direction of the valve body, and the tangent direction of the distal end of the connecting rod is set at an acute angle or parallel to the axial direction of the valve body.

5. The aortic valve according to claim 3 or 4, characterized in that: An arc transition connection is formed between the connecting rod and the limiting rod and / or the distal end of the limiting rod bends towards the valve body to form an anti-scratch structure; a connecting portion is provided at the proximal end of the connecting head, a matching portion is provided at the distal end of the delivery cable, and the connecting portion is detachably connected to the matching portion.

6. The aortic valve according to claim 2, characterized in that: The limiting rod and the valve body are integrally formed. One end of the limiting rod is fixedly connected to the valve body, the other end of the limiting rod is a free end, and the distal end of the connecting rod is detachably connected to the free end of the limiting rod.

7. The aortic valve according to claim 6, wherein: The limiting rod extends in an arc and bends away from the valve body. A clamping structure is provided at the distal end of the connecting rod. When the aortic valve is compressed and loaded in the delivery system, the clamping structure cooperates with the limiting rod. When the aortic valve is deployed and released, the clamping structure is disengaged from the limiting rod.

8. The aortic valve according to claim 7, wherein: The clamping structure includes a first arc segment, a first straight segment, a second arc segment and a second straight segment. One end of the first arc segment is connected to the distal end of the connecting rod, the other end of the first arc segment is connected to one end of the first straight segment, the other end of the first straight segment is connected to one end of the second arc segment, and the other end of the second arc segment is connected to one end of the second straight segment; the first arc segment bends towards the distal end, and the second arc segment bends towards the proximal end.

9. The aortic valve according to claim 8, characterized in that: The radian of the first arc segment and the second arc segment is less than or equal to π. When the aortic valve is compressively loaded in the delivery system, the distal end of the limiting rod is located within the first arc segment. When the aortic valve is gradually deployed until fully deployed, the distal end of the limiting rod sequentially passes through the first arc segment, the first straight segment, the second arc segment, and the second straight segment until the limiting rod disengages from the clamping structure.

10. A delivery system for delivering an aortic valve as described in any one of claims 1-9 to a diseased location, characterized in that: The delivery system includes a sheath and a delivery cable. The aortic valve can be compressively loaded within the sheath. The proximal end of the connector is connected to the distal end of the delivery cable. The sheath can be moved proximally to release the aortic valve.

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