Valve system

Abstract

The invention provides a valve system which comprises a valve prosthesis and a conveyor, the valve prosthesis has a conveying state and a working state, in the conveying state, the valve prosthesis is compressed in the conveyor, in the working state, the valve prosthesis is completely released from the conveyor, the valve prosthesis comprises an inflow end and an outflow end, and the valve prosthesis comprises a support body and a clamping piece. The clamping piece is used for clamping the native valve leaflet, the clamping piece is arranged on the outer side of the support body in a sleeving mode, the native valve leaflet is fixed between the support body and the clamping piece, the clamping piece comprises a first connecting position, a second connecting position and a third connecting position which are arranged in the circumferential direction, and the first connecting position, the second connecting position and the third connecting position are all arranged on the side, close to the outflow end, of the clamping piece.

Description

Technical Field

[0001] This invention relates to the field of interventional medical device technology, and more particularly to a valve system. Background Technology

[0002] Currently, the mainstream artificial valves on the market are mainly for two indications: aortic valve calcification (stenosis) and regurgitation. However, due to their different pathological mechanisms, the fixation methods used differ significantly. Calcified lesions typically rely on the radial support force of nickel-titanium or cobalt-chromium alloy stents to anchor them in the calcified valve annulus region; while regurgitation lesions, due to the lack of calcified tissue in the valve annulus, cannot achieve stable anchoring through radial support, and therefore often use a method of clamping the autologous valve leaflet for fixation. However, with this method, the clamping device may not be able to hold the autologous valve leaflet well during release. For example, inaccurate clamping position or insufficient clamping depth can cause the artificial valve to easily detach from the autologous valve leaflet with each heartbeat, posing a safety risk. Summary of the Invention

[0003] To address the aforementioned issues, a valve prosthesis that is not easily dislodged and has good fixation is provided.

[0004] A valve prosthesis includes a valve prosthesis and a delivery device. The valve prosthesis has a delivery state and a working state. In the delivery state, the valve prosthesis is compressed within the delivery device. In the working state, the valve prosthesis is completely released from the delivery device. The valve prosthesis includes an inflow end and an outflow end. The valve prosthesis includes a support body and a clamping member. The clamping member is used to clamp the native valve leaflet. The clamping member is sleeved on the outside of the support body. The native valve leaflet is fixed between the support body and the clamping member. The clamping member includes a first connection, a second connection, and a third connection arranged circumferentially. The first connection, the second connection, and the third connection are all located on the side of the clamping member near the outflow end. At least one of the first connection point, the second connection point, and the third connection point can only be connected to the stent body, and at least one of the three can only be detachably connected to the delivery device; or, when the valve prosthesis is in the delivery state, at least one of the first connection point, the second connection point, and the third connection point is detachably connected to the stent body after being unrestrained, and then detachably connected to the delivery device; when the valve prosthesis is in the working state, the unrestrained connection becomes a fixed connection.

[0005] In the above embodiments, a portion of the first, second, and third connecting points are connected to the stent body, while another portion remains unconnected. Alternatively, the first, second, and third connecting points are loosely connected to the stent body during transport, but become fixed during operation. This minimizes the constraint of the stent body on the clamping component, allowing for greater freedom of release and a better posture to clamp the native leaflet. This results in more accurate clamping and a better clamping degree, improving the fixation performance and safety of the valve prosthesis. Simultaneously, the structural connection between the stent body and the clamping component during operation prevents displacement of the stent body and clamping component within the body with heartbeats, further ensuring the fixation performance of the valve prosthesis and preventing detachment from the native leaflet, significantly enhancing safety. Attached Figure Description

[0006] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0007] Figure 1 This is a schematic diagram of the structure of a valve system provided in one embodiment; Figure 2 This is a schematic diagram of the structure of a valve prosthesis provided in one embodiment; Figure 3 This is a schematic diagram of a valve prosthesis placed within a target tissue according to one embodiment. Figure 4 This is a schematic diagram of the structure of a clamping member provided in one embodiment; Figure 5 A schematic diagram of a valve system in one state according to an embodiment; Figure 6 A schematic diagram of a valve system in one state according to an embodiment; Figure 7 A schematic diagram of the structure of a conveyor provided in one embodiment; Figure 8 A schematic diagram of a valve system in one state according to an embodiment; Figure 9 A schematic diagram of a valve system in one state according to an embodiment; Figure 10 A partial structural schematic diagram of a conveyor provided in one embodiment; Figure 11 This is a schematic diagram of the structure of the support body provided in one embodiment; Figure 12 This is a schematic diagram of the connection between the clamping component and the support body according to one embodiment; Figure 13 This is a schematic diagram of the structure of a clamping member provided in one embodiment; Figure 14 This is a schematic diagram of a support body and a clamping member in a non-restrained connection state according to one embodiment. Figure 15 This is a schematic diagram of a support body and a clamping member in a fixed connection state according to one embodiment; Figure 16 A schematic diagram of a valve system provided in one embodiment, showing it in one state from another angle; Figure 17 A schematic diagram of a valve system provided in one embodiment, showing it in one state from another angle; Figure 18 A schematic diagram of a valve system in one state according to an embodiment; Figure 19 A schematic diagram of the structure of the leaflet and leaflet connector provided in one embodiment; Figure 20 A schematic diagram of the unfolded structure of the leaflet provided in one embodiment; Figure 21 for Figure 2 Enlarged view of part of the structure at point Q; Figure 22 A schematic diagram of the structure of the first connecting part and the second connecting part provided in one embodiment; Figure 23 This is a schematic diagram of the structure of a leaflet connector provided in one embodiment; Figure 24 This is a schematic diagram of the structure of the valve leaf, skirt, and valve leaf connector provided in one embodiment. Figure 25 A schematic diagram of the unfolded structure of the leaflet provided in one embodiment; Figure 26 This is a schematic diagram of the structure of the valve leaf, skirt, and valve leaf connector provided in one embodiment. Figure 27 This is a schematic diagram of the structure of the outer skirt and the inner skirt provided in one embodiment; Figure 28 A schematic diagram of a leaflet structure or inner skirt structure provided in one embodiment; Figure 29 This is a schematic diagram of an inner skirt structure or an outer skirt structure provided in one embodiment; Figure 30 This is a schematic diagram of an outer skirt structure provided in one embodiment. Detailed Implementation

[0008] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0009] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0010] It should be noted that the terms "distal" and "proximal" are used as directional terms, which are commonly used in the field of interventional medical devices. "Distal" refers to the end furthest from the operator during the procedure, while "proximal" refers to the end closest to the operator. Axial direction refers to the direction parallel to the line connecting the center of the distal and proximal ends of the medical device; radial direction refers to the direction perpendicular to the aforementioned axial direction.

[0011] See Figure 1 This embodiment provides a valve system 1000, including a valve prosthesis 100 and a delivery device 200. The valve prosthesis 100 has a delivery state and an operating state. In the delivery state, the valve prosthesis 100 is compressed within the delivery device 200. In the operating state, the valve prosthesis 100 is completely released from the delivery device 200.

[0012] See Figure 2 and Figure 3 The valve prosthesis 100 includes an inflow end A and an outflow end B. The valve prosthesis 100 includes a support body 1 and a clamping member 11. The clamping member 11 is used to hold the original leaflet M. The clamping member 11 is sleeved on the outside of the support body 1, and the original leaflet M is fixed between the support body 1 and the clamping member 11. The valve prosthesis 100 also includes leaflets 2 and a skirt 3.

[0013] See Figure 4 The clamping member 11 includes a first connection 111, a second connection 112, and a third connection 113 arranged circumferentially. The first connection 111, the second connection 112, and the third connection 113 are all located on the side of the clamping member 11 near the outlet end B. The side near the outlet end B can be understood as being at the outlet end B of the clamping member 11, or at a position close to the outlet end B of the clamping member 11.

[0014] See Figure 5In one embodiment, at least one of the three connections 111, 112, and 113 can only be connected to the support body 1, and at least one of the three can only be detachably connected to the conveyor 200. It should be noted that, of the three connections 111, 112, and 113, the one connected to the support body 1 is not connected to the conveyor 200; and the one not connected to the support body 1 is connected to the conveyor 200.

[0015] In another embodiment, when the valve prosthesis 100 is in the delivery state, see [reference needed]. Figure 6 At least one of the three connections 111, 112 and 113 is connected to the stent body 1 in a non-restrained manner, and then is detachably connected to the delivery device 200. When the valve prosthesis 100 is in working condition, the non-restrained connection becomes a fixed connection. Figure 6 The valve prosthesis 100 is in a semi-released state, somewhere between a delivery state and a working state. At this point, the clamping member 11 has been released, but the stent body 1 has not yet been released from the delivery device 200. It can be understood that as long as the valve prosthesis 100 is not in the working state, at least one of the three connections 111, 112, and 113 is only in a non-binding connection with the stent body 1, and is not fixedly connected. In this embodiment of the invention, a non-binding connection can be understood as meaning that as long as the valve prosthesis 100 is not in the working state, there is no interaction force between the stent body 1 and the clamping member 11.

[0016] In the above embodiments, a portion of the first connection 111, the second connection 112, and the third connection 113 is connected to the stent body 1, while another portion is not connected to the stent body 1; or, the first connection 111, the second connection 112, and the third connection 113 are non-bindingly connected to the stent body 1 in the delivery state, and become fixedly connected in the working state. This can minimize the restraint of the stent body 1 on the clamping member 11, allowing the clamping member 11 to be more free after release, and to have a better posture after release to clamp the original leaflet M. It is easier to achieve a more accurate clamping position and a better clamping degree of the clamping member 11, thereby improving the fixation performance of the valve prosthesis 100 and increasing its safety. Meanwhile, when in working condition, there is a structural connection between the stent body 1 and the clamping component 11, which prevents the stent body 1 and the clamping component 11 from shifting relative to each other in the body as the heart beats, further ensuring the fixation performance of the valve prosthesis 100, preventing the valve prosthesis 100 from falling off the original leaflet M, and greatly improving safety performance.

[0017] Specifically, in one embodiment, see [reference] Figure 4 and Figure 5The first connection 111 can only be connected to the stent body 1, and its connection method includes a fixed connection or a movable connection. The second connection 112 and the third connection 113 can only be detachably connected to the delivery device 200. In other embodiments, the first connection 111 and the second connection 112 can only be connected to the stent body 1, and their connection methods include a fixed connection or a movable connection. The third connection 113 can only be detachably connected to the delivery device 200. In another embodiment, the movable connection can also be understood as a non-restraint connection. When the valve prosthesis 100 is in the working state, the non-restraint connection becomes a fixed connection.

[0018] In one embodiment, see Figure 6 When the valve prosthesis 100 is in the delivery state, the first connection 111 is non-bindingly connected to the stent body 1 and then detachably connected to the delivery device 200. When the valve prosthesis 100 is in the working state, the non-binding connection becomes a fixed connection. The second connection 112 and the third connection 113 are each detachably connected only to the delivery device 200. In other embodiments, the first connection 111 and the second connection 112 are non-bindingly connected to the stent body 1 and then detachably connected to the delivery device 200. When the valve prosthesis 100 is in the working state, the non-binding connection becomes a fixed connection. The third connection 113 is each detachably connected only to the delivery device 200. In other embodiments, the first connection 111, the second connection 112, and the third connection 113 are non-bindingly connected to the stent body 1 and then detachably connected to the delivery device 200. When the valve prosthesis 100 is in the working state, the non-binding connection becomes a fixed connection.

[0019] In one embodiment, see Figure 7 and Figure 8 The conveyor 200 includes an outer sheath 101 and a sheath core 102, with the sheath core 102 disposed within the outer sheath 101. The conveyor 200 also includes a first elongated member 103 and a second elongated member 104, both disposed within the outer sheath 101. The distal end or near-distal position of the first elongated member 103 is detachably connected to the distal end or near-distal position of the second elongated member 104, forming a closed structure N. At least one of the first connection 111, the second connection 112, and the third connection 113 is detachably confined within the closed structure N. By pulling or pushing at least one of the proximal ends of the first elongated member 103 or the second elongated member 104, the distal end or near-distal position of the first elongated member 103 is detached from the distal end or near-distal position of the second elongated member 104.

[0020] Specifically, in this embodiment, a fixing member 1021 is provided on the sheath core 102, combined with... Figure 2 , Figure 7 and Figure 8A support connector 12 is provided at the outlet end B of the support body 1. The support connector 12 is fixed to the fixing member 1021 and passes through the outer sheath 101, thereby realizing the fixed connection between the support body 1 and the conveyor. When the outer sheath 101 is retracted, the support connector 12 can be detached from the fixing member 1021, thereby releasing the support body 1.

[0021] In this embodiment, the proximal end of the first elongated member 103 can be disposed on the fixing member 1021, and the proximal end of the second elongated member 104 extends to the proximal end of the outer sheath 101. By pulling or pushing the proximal end of the second elongated member 104, the distal end or near-distal position of the first elongated member 103 can be disengaged from the distal end or near-distal position of the second elongated member 104. Further, the second elongated member 104 is movably inserted into the fixing member 1021. The fixing member 1021 can radially limit the second elongated member 104, but does not affect the axial movement of the second elongated member 104. This allows for radial positioning of the relative positions of the first elongated member 103 and the second elongated member 104, facilitating a detachable connection between the distal end or near-distal position of the first elongated member 103 and the distal end or near-distal position of the second elongated member 104.

[0022] In other embodiments, the proximal end of the first elongated member 103 may also extend together with the proximal end of the second elongated member 104 to the proximal end of the outer sheath 101.

[0023] Furthermore, in one embodiment, an annular structure 1031 is provided at the distal end or near the distal end of the first elongated member 103, and the distal end of the second elongated member 104 passes through the annular structure 1031 to form a closed structure N. In other embodiments, a hook-shaped structure is provided at the distal end or near the distal end of the first elongated member 103, and another hook-shaped structure is provided at the distal end or near the distal end of the second elongated member 104, the two hook-shaped structures being detachably connected.

[0024] Further, see Figure 9In one embodiment, a limiting member 1032 is provided near the distal end of the first elongated member 103. In the conveying state, the limiting member 1032 is located on the proximal side of the closed structure N. Specifically, in the conveying state, the limiting member 1032 is located on the proximal side of the annular structure 1031. The outer diameter of the limiting member 1032 is larger than the outer diameter of the first elongated member 103. One of the three connections, namely the first connection 111, the second connection 112, and the third connection 113, is located between the limiting member 1032 and the annular structure 1031, thereby realizing the limiting function. Furthermore, when the first elongated member 103 has a certain degree of rigidity and can provide support, when the clamping member 11 is released, pushing the first elongated member 103 towards the distal end will cause the limiting member 1032 to generate a pushing force on one of the three connections 111, 112, and 113 connected to the closed structure N. This adjusts the release position of the clamping member 11 within the body, improving operational flexibility and allowing the clamping member 11 to be released to the most suitable position. In other embodiments, the limiting member 1032 can also be located near the distal end of the second elongated member 104, as long as the position of the limiting member 1032 does not restrict the release of the clamping member 11. In one embodiment, at least one of the first elongated member 103 and the second elongated member 104 may be made of materials such as nickel-titanium or stainless steel, giving the first elongated member 103 and / or the second elongated member 104 a certain supporting performance, better fixing the clamping member 11, and more easily providing the aforementioned pushing force. See also Figure 9 The first slender component 103 is made of woven wires of metals such as nickel and titanium; see [link / reference] Figure 10 The first slender part 103 can also be cut from metal materials such as nickel and titanium.

[0025] In one embodiment, see Figure 2 , Figure 4 , Figure 5 and Figure 11 At least one of the three connections 111, 112 and 113 can be connected to the support body 1 to form at least one connection part 13. The support body 1 is provided with a hole structure 130. The end of the clamping member 11 located at the outflow end passes through the hole structure 130 to form the connection part 13.

[0026] Specifically, in one embodiment, see [reference] Figure 4 The clamping component 11 is entirely made of a single filament structure, the material of which can be the same as that of the support body 1, namely nickel-titanium. Specifically, combined with Figure 4 , Figure 5 and Figure 11At the first connection 111, the clamping member 11 includes a first end 11a and a second end 11b. Both the first end 11a and the second end 11b pass through the hole structure 130 from the outer surface of the support body 1 and are fixed to form a connecting portion 13. In other embodiments, at least one of the first end 11a and the second end 11b passes through the hole structure 130 from the inner surface of the support body 1 and is fixed to form a connecting portion 13. This arrangement allows the clamping member 11 to fit more tightly with the support body 1, increasing the clamping force of the clamping member 11, thereby improving the fixation of the clamping member 11 on the original leaflet and preventing the valve prosthesis 100 from shifting and falling off.

[0027] In other embodiments, the clamping member 11 may also be made of three filamentous structures connected end to end in the circumferential direction, with two ends at the first connection 111 and two ends at the second connection 112 or the third connection 113. The hole structure 130 may be one or two small holes.

[0028] Further, see Figure 12 The end of the clamping member 11 or a position near the end of the clamping member 11 is inserted into the hole structure 130 and can move within the hole structure 130, as well as be confined within the hole structure 130. In this embodiment, the hole structure 130 is an oblong hole. The first end 11a and the second end 11b of the clamping member 11 are respectively inserted into the two hole structures 130 and can move within the range of the hole structure 130, but cannot detach from the hole structure 130. This ensures that the first connection 111 can only have a certain degree of flexibility at the position where it is connected to the support body 1, further reducing the influence of the support body 1 on the clamping member 11 after release. This allows the clamping member 11 to be more free after release, with a better posture after release to clamp the original leaflet M, making it easier to achieve a more accurate clamping position and a better clamping degree, thereby improving the fixation performance of the valve prosthesis 100 and increasing its safety. The clamping member 11 can be positioned within the hole structure 130 near its end by having its end pass through the hole structure 130 and then forming a ball-head structure at its end to prevent it from detaching from the hole structure 130. Alternatively, the clamping member 11 can be positioned within the hole structure 130 by having a sliding member at its end and a groove on the inner wall of the hole structure 130, whereby the sliding member slides and is positioned within the groove.

[0029] In one embodiment, see Figure 6 , Figure 9 and Figure 13 At least one of the three connections 111, 112 and 113 is provided with a connection hole 11c.

[0030] When at least one of the three connections 111, 112, and 113 is detachably connected to the conveyor 200 but not to the support body 1, see [reference needed]. Figure 9 For example, at the second connection 112, the end of the first elongated member 103 is inserted into the connection hole 11c, and the second elongated member 104 is inserted into the annular structure 1031 at the end of the first elongated member 103. At this time, the connection hole 11c can better fix the first elongated member 103, the second elongated member 104 and the second connection 112. At the same time, the clamping member 11 can be better exerted at the second connection 112, and the movement of the clamping member 11 can be better controlled. When the valve prosthesis 100 is in the delivery state, at least one of the three connections 111, 112, and 113 is non-restrainedly connected to the stent body 1, and then detachably connected to the delivery device 200. (See attached image.) Figure 6 A connection hole 11c is provided to facilitate better connection of at least one of the three connections 111, 112 and 113 to the support body 1. Furthermore, the connection hole 11c can be detachably connected to the conveyor 200. In other words, a single connection hole 11c can be provided to achieve two connection methods.

[0031] In one embodiment, see Figure 14 and Figure 15 At least one of the three connection points 111, 112, and 113 is connected to the stent body 1 in a non-restrained manner via a connecting line 11c1. A slipknot 11c11 is provided on the proximal side of the connecting line 11c1. When the valve prosthesis 100 is in the working state, the slipknot 11c11 is pushed distally to convert the non-restrained connection into a fixed connection. The slipknot can be a common fisherman's knot, etc. Furthermore, after the fixed connection is completed, excess connecting line 11c1 can be cut off using a suture cutter.

[0032] In other embodiments, a knotter is provided on the proximal side of the connecting wire 11c1. When the valve prosthesis 100 is in the working state, the knotter is pushed to the distal end to change the non-restraint connection into a fixed connection. Furthermore, the excess connecting wire 11c1 can be cut off by a wire cutter.

[0033] See Figure 16 Specifically, in one embodiment, the first connection 111 can only be connected to the support body, while the second connection 112 and the third connection 113 can only be detachably connected to the conveyor 200. (Combined with...) Figure 5 and Figure 16At this point, the clamping element 11 has been released from the target tissue 2000, but the stent body 1 has not yet been released from the delivery device 200. Since the first connection 111 can only connect to the stent body 1, the delivery device 200 is positioned to adhere to the target tissue 2000, rather than at the center of the target tissue 2000 cavity, in order to better position the clamping element 11 for better clamping of the original leaflet M. This setting provides more space for introducing new instruments into the cavity of the target tissue 2000, and only requires the distal or near-distal end of the delivery device 200 to adhere to the inner wall of the target tissue 2000, making it easier for the operator to position the distal or near-distal end of the delivery device 200. In other embodiments, the first connection 111 and the second connection 112 can only be connected to the support body, and the third connection 113 can only be detachably connected to the conveyor 200. After the clamping member 11 is released at the target tissue 2000 position, the first connection 111 and the second connection 112 are connected to the support body 1. Therefore, the conveyor 200 can also be located at the position that fits the target tissue 2000, rather than at the center of the cavity of the target tissue 2000.

[0034] See Figure 17 In one embodiment, the first connection 111, the second connection 112 and the third connection 113 are all non-bindingly connected to the support body 1. At this time, the clamping member 11 has been released at the target tissue 2000 position, but the support body 1 has not yet been released from the conveyor 200. The conveyor 200 is located at the center of the cavity of the target tissue 2000.

[0035] See Figure 18 , Figure 18 The clamping member 11 has not yet been detached from the conveyor 200; it has only detached from the outer sheath 101 and is part of the structure near the inflow end.

[0036] In this embodiment, combined with Figure 7 and Figure 18 The delivery device 200 also includes a TIP head 105 connected to the sheath core 102. One end of the TIP head 105 has a groove 1051 for accommodating the inflow portion of the valve prosthesis 100. When the outer sheath 101 is axially separated from the TIP head 105, only the portion of the clamping member 11 near the inflow end can be released, while the stent body 1 can remain completely in place. This prevents the release of the stent body 1 from affecting the release of the clamping member 11, allowing for more precise control of the release of the clamping member 11. In other embodiments, the groove 1051 may not be provided.

[0037] In this embodiment, the entire release process can be as follows: First, as... Figure 8 or Figure 9 , and then as Figure 18 For example, Figure 5 or Figure 6 Finally, for example Figure 1 If it is necessary to convert a non-binding connection into a fixed connection, after completing... Figure 1 After the operation, proceed as follows: Figure 14 , Figure 15 The operation.

[0038] Combination Figure 19 and Figure 20 In one embodiment, the leaflet 2 includes at least two leaflet structures 20, each leaflet structure 20 including a leaflet angle 201. Adjacent leaflet structures 20 are interconnected via the leaflet angle 201. The valve prosthesis 100 also includes a leaflet connector 5, which is disposed and fixed between the leaflet 2 and the skirt 3. The leaflet connector 5 includes a first connecting portion 51 and a second connecting portion 52. The first connecting portion 51 is fixed axially outside the leaflet angle 201, and the second connecting portion 52 is radially wrapped around and fixed to the outflow end of the leaflet angle 201. The second connecting portion 52 reinforces the outflow end of the leaflet angle 201, preventing stress concentration and tearing of the leaflet. The first connecting portion 51 increases the fixing area between the leaflet 2 and the skirt 3, thereby increasing the overall connection strength.

[0039] in, Figure 21 for Figure 2 An enlarged view of the Q position, used to illustrate the structure of both leaflet 2 and skirt 3. Figure 21 Clamping component 13 is omitted. See also Figure 21 and Figure 22 The first connecting portion 51 and the second connecting portion 52 are fixed to each other in the radial direction, and the thickness of the second connecting portion 52 is less than the thickness of the first connecting portion 51. The thinner second connecting portion 52 avoids affecting the opening and closing of the leaflets, while the thicker first connecting portion 51 increases the elasticity of the leaflets in the direction of force, which is beneficial for buffering stress at the leaflet corner. Furthermore, the end of the first connecting portion 51 near the outflow end is flush with the end of the second connecting portion 52 near the outflow end, which improves the strength of the outflow end of the leaflet corner 201. In this embodiment, the skirt 3 is connected to the bracket 1, and the leaflet connector 5 is directly connected to the skirt 3.

[0040] In one embodiment, see Figure 23 The first connecting part 51 and the second connecting part 52 are integral structures, and are sequentially connected in the axial direction from the inflow end to the outflow end. In this embodiment, the first connecting part 51 and the second connecting part 52 are integral structures, which are simple in structure and convenient to manufacture and produce.

[0041] Among them, see Figure 19 and Figure 21In the leaflet connector 5, at least the first connecting portion 51 covers and is fixed to the leaflet corner 201, and the side of the second connecting portion 52 near the outflow end is flush with and fixed to the side of the leaflet 2 near the outflow end. This design allows the leaflet connector 5 to fit better with the leaflet 2, avoiding interference with the opening and closing of the leaflet 2. The first connecting portion 51 is wedge-shaped to better match the shape of the leaflet corner 201.

[0042] In one embodiment, the leaflet 2, the skirt 3, and the leaflet connector 5 are all made of polymer material, and any two of the three are connected by thermal fusion. The first connecting part 51 and the second connecting part 52 can also be connected and fixed by thermal fusion. The leaflet 2, the skirt 3, and the leaflet connector 5 are laser-cut from polymer sheets, and the polymer sheet molding process is simple and the performance is stable.

[0043] Furthermore, the leaflet 2 and the skirt 3 are connected and fixed by heat fusion, and then further secured with sutures. See also Figure 19 , Figure 20 and Figure 24 The end 21 of the leaflet near the inflow end is connected and fixed to the skirt 3 by thermal fusion, and then fixed again by the first suture 41, thereby forming at least two leaflet structures 20 on the leaflet 2 that can open and close, and improving the fixation performance between the leaflet 2 and the skirt 3. The end 21 of the leaflet near the inflow end is arc-shaped, the overlap area between the leaflet 2 and the skirt 3 is small, and the overall compressed outer diameter of the valve prosthesis 100 is smaller, which helps to reduce the difficulty of inserting the valve prosthesis 100 into the sheath.

[0044] In one embodiment, see Figure 25 and Figure 26 The end 21 of the leaflet near the inflow end has a straight structure, which increases the heat fusion range between the first suture 41 and the end 21 of the leaflet near the inflow end, allowing the leaflet 2 and the skirt 3 to fuse more fully, thereby improving the fixation performance of the leaflet 2 and the skirt 3.

[0045] In one embodiment, at the location of the petal corner 201, the petal leaf 2, the petal leaf connector 5, and the skirt 3 are first connected and fixed by heat fusion, and then fixed again by the second suture 42, thereby improving the connection strength at the location of the petal corner 201 and increasing fatigue life.

[0046] In one embodiment, see Figure 27 The skirt 3 includes an inner skirt 301 and an outer skirt 302 that are connected to each other. The inner skirt 301 and the outer skirt 302 are respectively disposed on the inner and outer surfaces of the support 1. See reference. Figure 28 The inner skirt 301 includes a PET layer 304 and polyurethane layers 305 disposed on the inner and outer surfaces of the PET layer, or see [link to relevant documentation]. Figure 29 The inner skirt 301 includes a PET layer 304 and a polyurethane layer 305 disposed on the inner surface of the PET layer; see also Figure 30 The outer skirt 302 includes a PET layer 304, or see [link to relevant documentation]. Figure 29 The outer skirt 302 includes a PET layer 304 and a polyurethane layer 305 disposed on the inner surface of the PET layer. The method for disposing of the polyurethane layer 305 on the surface of the PET layer 304 involves immersing the PET layer 304 in a polyurethane solution and then drying it. The thickness of the polyurethane layer 305 on the surface of the PET layer 304 is adjusted by setting the number of immersion-drying cycles. The outer skirt is made solely of a PET layer, or its outer surface is entirely composed of a PET layer. This increases friction and improves the anchoring stability of the valve prosthesis 100 at the inflow end, making it less prone to displacement or detachment within the body. In this embodiment, the inner skirt 301 and outer skirt 302 are separate structures. In other embodiments, the skirt 3 can also be a single unit. Physical shielding during the immersion process controls the number of immersion-drying cycles, thereby adjusting the different thicknesses of the inner skirt 301 and outer skirt 302. The PET used is polyethylene terephthalate.

[0047] In this embodiment, leaflet 2 also adopts Figure 28 The polymer material, polyurethane 305, possesses good biocompatibility, while the PET layer exhibits good strength and toughness, enhancing the overall strength of the leaflets and improving fatigue life. Specifically, the PET layer is woven from PET material. The PET layer used near the outflow end of the leaflet has a tighter weave structure to improve the wear resistance and tear resistance of the flange at the outflow end; the PET layer used near the inflow end has a looser weave structure to reduce the opening and closing resistance of the leaflets and effectively increase the EOA (Effective Orifice Area) opening area.

[0048] See Figure 25 The leaflet 2 has serrated structures 210 at both circumferential ends to facilitate its own thermal fusion or thermal fusion with other structures, thereby improving the efficiency and effectiveness of thermal fusion. Similarly, see... Figure 27 The inner skirt 301 has serrated structures 3010 at both ends of its circumference, and the outer skirt 302 has serrated structures 3020 at both ends of its circumference.

[0049] In one embodiment, the gap at the suture site can be closed by dripping polyurethane solution, thereby improving the sealing performance. The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A valve system comprising a valve prosthesis and a delivery device, the valve prosthesis having a delivery state in which the valve prosthesis is compressed within the delivery device and an operational state in which the valve prosthesis is fully released from the delivery device, the valve prosthesis comprising an inflow end and an outflow end, characterized in that, The valve prosthesis comprises a stent body and a clamping member for clamping a native leaflet, the clamping member is sleeved on the outside of the stent body, the native leaflet is fixed between the stent body and the clamping member, the clamping member comprises a first connection, a second connection and a third connection arranged circumferentially, the first connection, the second connection and the third connection are arranged on one side of the clamping member close to the outflow end, At least one of the first connection, the second connection and the third connection can only be connected with the stent body, at least one of the first connection, the second connection and the third connection can be releasably connected with the delivery device; or, when the valve prosthesis is in the delivery state, at least one of the first connection, the second connection and the third connection is non-restrictively connected with the stent body, and then is releasably connected with the delivery device, when the valve prosthesis is in the working state, the non-restrictive connection becomes a fixed connection.

2. The valve system of claim 1, wherein, The delivery device comprises an outer sheath, and the delivery device further comprises a first elongated member and a second elongated member arranged in the outer sheath, a distal end or a position close to the distal end of the first elongated member is releasably connected with a distal end or a position close to the distal end of the second elongated member to form a closed structure, at least one of the first connection, the second connection and the third connection is releasably positioned in the closed structure, by pulling or pushing at least one of a proximal end of the first elongated member or a proximal end of the second elongated member, the distal end or the position close to the distal end of the first elongated member is released from the distal end or the position close to the distal end of the second elongated member.

3. The valve system of claim 2, wherein, A ring structure is arranged on the distal end or the position close to the distal end of the first elongated member, and a distal end of the second elongated member penetrates into the ring structure to form the closed structure.

4. The valve system of claim 2, wherein, A limiting member is arranged on the position close to the distal end of the first elongated member or the position close to the distal end of the second elongated member, and the limiting member is arranged on the proximal side of the closed structure in the delivery state.

5. The valve system of claim 1, wherein, At least one of the first connection, the second connection and the third connection can only be connected with the stent body to form at least one connection part, and the stent body is provided with a hole structure, and an end or a position close to the end of the clamping member penetrates into the hole structure to form the connection part.

6. The valve system of Claim 5, wherein, The end or the position close to the end of the clamping member penetrates into the hole structure and can move in the hole structure and be positioned in the hole structure.

7. The valve system of claim 1, wherein, At least one of the first connection, the second connection and the third connection is provided with a connecting hole.

8. The valve system of claim 1, wherein, At least one of the first connection, the second connection and the third connection is non-restrictively connected with the stent body through a connecting line, a proximal side of the connecting line is provided with a running knot or a knotter, and when the valve prosthesis is in the working state, the running knot or the knotter is pushed to the distal end to change the non-restrictive connection into a fixed connection.

9. The valve system of claim 1, wherein, The valve prosthesis further comprises a leaflet and a skirt, the leaflet comprises at least two leaflet structures, the leaflet structures comprise a commissure, adjacent leaflet structures are connected to each other through the commissure, the valve prosthesis further comprises a leaflet connector, the leaflet connector is arranged and fixed between the leaflet and the skirt, wherein the leaflet connector comprises a first connecting portion and a second connecting portion, the first connecting portion is fixed outside the commissure in the axial direction, and the second connecting portion is wrapped outside the position of the outflow end of the commissure in the radial direction and is fixed.

10. The valve system of claim 9, wherein, The leaflet, the skirt and the leaflet connector are all high molecular materials, and any two of the leaflet, the skirt and the leaflet connector are connected by heat fusion.

Images