Valve prosthesis

Abstract

The valve prosthesis comprises a support, a covering film and a valve leaflet assembly, a main body part of the support comprises a plurality of suture rods arranged at intervals in the circumferential direction, the two ends of each suture rod are connected with an outflow end and an inflow end respectively, the covering film comprises a first covering film, and the first covering film is arranged on the side wall of the support and connected with the valve leaflet assembly; the first covering film comprises a first covering film connecting part and a first covering film main body, the first covering film connecting part protrudes towards the outflow end, the first covering film connecting part comprises a valve angle connecting part and a transition part which are connected with each other, the valve angle connecting part is connected with the valve leaflet and the suture rod, and the transition part is connected between the valve angle connecting part and the first covering film main body; a joint is arranged between the transition part and the valve angle connecting part, a notch is formed in the edge of the joint, the valve angle connecting part and the transition part are partially separated in the axial direction through the notch, the side, close to the joint, of the transition part is provided with a free side, the transition part is kept in an unfolded state, and therefore blood is prevented from being retained in the transition part to generate thrombus.

Description

Technical Field

[0001] This application relates to the field of interventional medical device technology, specifically to a valve prosthesis. Background Technology

[0002] When the native heart valve narrows, or leaks or regurgitates (e.g., due to leaflet calcification), heart valve replacement surgery can be performed. In one treatment option, the native valve can be removed and replaced with a valve prosthesis. The valve prosthesis includes a stent, a clasp, and leaflets. The leaflets are positioned inside the stent and connected to the suture bar via the leaflet angles. The clasp covers the leaflet angles and extends further down the leaflet angle area (i.e., towards the inflow end). Therefore, the suture site at the leaflet angle has a relatively complex and three-dimensional structure with many folds and grooves, making it less smooth. As the heart beats, blood can easily stagnate in these folds and grooves, leading to thrombosis. Summary of the Invention

[0003] Therefore, it is necessary to provide a valve prosthesis, including an inflow end and an outflow end. The valve prosthesis includes a support, a cover, and a leaflet assembly. The support includes an outflow end, a main body, and an inflow end connected in sequence. The main body includes a plurality of circumferentially spaced fasteners. The leaflet assembly includes a plurality of leaflets, with adjacent leaflets sutured to the same fastener. The cover is at least located at the inflow end. The cover includes a first cover, which is disposed on the sidewall of the support and connected to the leaflet assembly. The first cover includes a first cover connecting portion and a first cover body. A first coating connection portion protrudes towards the outflow end. The first coating connection portion includes a petal corner connection portion and a transition portion that are connected to each other. The petal corner connection portion is connected to the petal leaf and the fixing member. The transition portion is connected between the petal corner connection portion and the first coating body. There is a connection between the transition portion and the petal corner connection portion. The edge of the connection portion is provided with a cut. The cut causes the petal corner connection portion and the transition portion to be partially separated in the axial direction. Thus, after the petal corner connection portion is connected to the petal leaf and the fixing member, the side of the transition portion near the connection portion has a free edge.

[0004] Compared with existing technologies, the beneficial effects of the above-mentioned valve prostheses are:

[0005] The aforementioned valve prosthesis includes a first cover consisting of a first cover connecting part and a first cover body. The first cover connecting part protrudes towards the outflow end and includes a valve corner connecting part and a transition part that are interconnected. The valve corner connecting part is connected to the valve leaflet and the fixation member. The transition part is connected between the valve corner connecting part and the first cover body. There is a connection between the transition part and the valve corner connecting part. The edge of the connection part is provided with an incision. The incision separates the valve corner connecting part and the transition part axially. After the valve corner connecting part is connected to the valve leaflet and the fixation member, the side of the transition part near the connection part has a free edge, so that the transition part and the valve corner connecting part can have a certain degree of relative independence. The wrinkles and grooves generated after the valve corner connecting part covers the valve leaflet and the fixation member are not transmitted to the transition part, so that the transition part remains flat, thereby reducing the formation of thrombi. 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 prosthesis in one embodiment;

[0008] Figure 2 This is a schematic diagram of the coating structure in one embodiment;

[0009] Figure 3 This is a schematic diagram of the unfolded structure of the coating in one embodiment;

[0010] Figure 4 This is a schematic diagram of the support structure in one embodiment;

[0011] Figures 5 to 8 This is a schematic diagram of the assembly process of the stent, the membrane, and the leaflet assembly in one embodiment;

[0012] Figure 9 This is a schematic diagram of the structure of a valve prosthesis in one embodiment;

[0013] Figure 10 This is a schematic diagram of the unfolded structure of the bracket in one embodiment;

[0014] Figure 11 This is a schematic diagram of the compression structure of the bracket in one embodiment;

[0015] Figure 12 This is a partial structural diagram of a valve prosthesis in one embodiment;

[0016] Figure 13This is a partial structural diagram of a valve prosthesis in one embodiment;

[0017] Figure 14 This is a partial structural diagram of a valve prosthesis in one embodiment;

[0018] Figure 15 This is a partial structural diagram of a valve prosthesis in one embodiment. Detailed Implementation

[0019] 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.

[0020] 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.

[0021] In the field of interventional medical devices, "distal" is generally defined as the end furthest from the operator during surgery, and "proximal" is defined as the end closest to the operator during surgery. Valve prostheses typically have open and closed states. When the valve prosthesis is open, blood flow can pass through it; when it is closed, blood flow is impeded. When the valve prosthesis is open, refer to... Figure 1 The end where blood flows into the valve prosthesis is defined as the inflow end 242, and the end where blood flows out of the valve prosthesis is defined as the outflow end 241.

[0022] This embodiment provides a valve prosthesis 200 for intervention in the aortic valve, mitral valve, tricuspid valve, pulmonary valve, or other vascular valve locations to replace the original valve and achieve heart valve replacement. Figure 1 As shown, the valve prosthesis 200 includes a support 210, a covering 260, and a leaflet assembly 230. The support 210 includes an outflow end 211, a main body 212, and an inflow end 213 connected in sequence. The main body 212 includes a plurality of fasteners 2120 arranged circumferentially, wherein the fasteners 2120 can be suture rods 2121, and the two ends of the suture rods 2121 are respectively connected to the outflow end 211 and the inflow end 213. The leaflet assembly 230 includes a plurality of leaflets 2301, and two adjacent leaflets 2301 are sutured to the same suture rod 2121. The covering 260 is provided at least at the inflow end 213.

[0023] See Figure 2 and Figure 3 The membrane 260 includes a first membrane 2601, which is disposed on the side wall of the support 210 and connected to the leaflet assembly 230. The first membrane 2601 includes a first membrane connecting portion 2601a and a first membrane body 2601b. The first membrane connecting portion 2601a protrudes toward the outflow end 241 and includes a valve corner connecting portion 2601a1 and a transition portion 2601a2 connected to each other. The valve corner connecting portion 2601a1 is connected to the leaflet 2301 and the suture rod 2121, and the transition portion 2601a2 is connected between the valve corner connecting portion 2601a1 and the first membrane body 2601b.

[0024] Combination Figure 1 and Figure 2 The transition portion 2601a2 and the valve angle connecting portion 2601a1 have a connection point P. A cut M is provided at the edge of the connection point P, which partially separates the valve angle connecting portion 2601a1 and the transition portion 2601a2 axially. After the valve angle connecting portion 2601a1 connects the leaflet 2301 and the fixing member 2120, the side of the transition portion 2601a2 near the connection point P has a free edge Q. This configuration allows the transition portion 2601a2 and the valve angle connecting portion 2601a1 to have a certain degree of relative independence. Wrinkles and grooves created by the valve angle connecting portion 2601a1 covering the leaflet 2301 and the fixing member 2120 are not transmitted to the transition portion 2601a2, keeping the transition portion 2601a2 flat and thus reducing thrombus formation.

[0025] See again Figure 2 In this embodiment, the flap corner connecting portion 2601a1 includes a first covering portion 32 and a second covering portion 33. The first covering portion 32 and the second covering portion 33 move toward each other to cover the fixing member 2020 (suture rod 2121), thereby facilitating the covering. Before the first covering portion 32 and the second covering portion 33 move toward each other, there is a cut M between the first covering portion 32 and the transition portion 2601a2, and / or, there is another cut M between the second covering portion 33 and the transition portion 2601a2.

[0026] The incision M can be a linear incision or an open-shaped incision. In this embodiment, the incision M is a straight incision. In other embodiments, it can be an arc-shaped or zigzag-shaped linear incision, which can reduce stress concentration and prevent tearing. An open-shaped incision refers to removing a certain amount of the coating material to create an opening. This allows the transition portion 2601a2 to remain flat while also providing sufficient space for the flap corner connection portion 2601a1 to connect with the leaflet 2301 and the fixing member 2120 without causing interference.

[0027] In this embodiment, combined with Figure 2 and Figure 4 The corner connecting portion 2601a1 also includes a middle portion 34, with a first covering portion 32 and a second covering portion 33 located on either side of the middle portion 34. The middle portion 34 has a window 341. The fastener 2020 includes a plurality of fixed windows 342, which are interconnected with the window 341. Each fixed window 342 includes a plurality of interconnected fixed window bars 3421. See also Figure 5 Leaflet 2301 includes leaf angle 2300.

[0028] See Figures 5 to 8 The assembly process of the stent 210, the membrane 260, and the leaflet assembly 230 is described: Figure 5 In the middle, the petal corners 2300 of two adjacent petals 2301 are neatly stacked and simultaneously inserted into the window 341; in Figure 6 In the process, the pre-assembled leaflet 2301 and the covering membrane 260 are mounted onto the support 210. The mounting method involves inserting the leaflet angle 2300 of the window 341 into which the covering membrane 260 is installed into the fixed window 342 on the support 210. Figure 7 In the middle, each corner 2300 is wrapped around a fixed window rod 3421, then extends into the bracket 210, and then passes through the window 341 again; Figure 8 Then, the first covering part 32 and the second covering part 33 move towards each other to cover the leaflet angle 3421 onto the fixing member 2120 of the support 210. The above assembly process makes the assembly process easier to operate and better fixes the support 210, the membrane 260 and the leaflet assembly 230.

[0029] See again Figure 2 The end of the middle portion 34 facing the outlet end 241 is closer to the outlet end 241 than the end of the first covering portion 32 facing the outlet end 241, and / or, the end of the middle portion 34 facing the outlet end 241 is closer to the outlet end 241 than the end of the second covering portion 32 facing the outlet end 241. With this arrangement, when the middle portion 34 is abutted by the fastener 2120, the first covering portion 32 and the second covering portion 33 are less likely to be interfered with by the middle portion 34, making the covering action easier.

[0030] See Figure 1 The leaflet 2301 and the transition portion 2601a2 are fixed together to form a fixing point N. The distance between the fixing point N and the nearest edge of the two sides of the transition portion 2601a2 is at least 1 mm. This setting can prevent the distance between the fixing point N and the nearest edge of the two sides of the transition portion 2601a2 from being too small. In this case, the fixing point N may be subjected to excessive force on the transition portion 2601a2 before or after the valve prosthesis 200 is released or during the contraction and relaxation of the heart, which could cause the fixing point N to shift on the transition portion 2601a2 and fall off, resulting in paravalvular leakage of the valve prosthesis 200.

[0031] Combined Figure 1 A support structure 300 is provided on the transition portion 2601a2. The support structure 300 is fixed to the transition portion 2601a2 to smooth the surface of the transition portion 2601a2 and keep the transition portion 2601a2 in an unfolded state. The support structure 300 can be fixed to the transition portion 2601a2 by means of sewing with thread, gluing, or welding.

[0032] The aforementioned valve prosthesis 200 includes a main body 212 comprising multiple circumferentially spaced suture rods 2121, with each end of the suture rod 2121 connected to an outflow end 211 and an inflow end 213, thus preventing obstruction of coronary blood flow or hindering coronary intervention surgery. Simultaneously, the first overlay 2601 includes a first overlay connecting portion 2601a and a first overlay main body 2601b. The first overlay connecting portion 2601a protrudes towards the outflow end 241 and includes interconnected valve corner connecting portions 2601a1 and transition portions 2601a2. The valve corner connecting portion 2601a1 connects to the valve leaflet 241. 301. The suture rod 2121 is connected, and the transition part 2601a2 is used to connect the valve angle connection part 2601a1 and the first covering body 2601b. The transition part 2601a2 is provided with a support structure 300, which is fixed on the transition part 2601a2 to smooth the surface of the transition part 2601a2 and keep the transition part 2601a2 in an unfolded state. Before and after the valve prosthesis 200 is released or with the contraction and relaxation of the heart, the transition part 2601a2 can be prevented from becoming wrinkled and uneven, thereby preventing blood from stagnating in the transition part 2601a2 and causing thrombosis, thus avoiding safety hazards.

[0033] In this embodiment, the covering film 260 further includes a second covering film 2602 connected to the first covering film 2601. The first covering film 2601 is disposed on the inner wall of the support 210, and the second covering film 2602 is disposed on the outer wall of the support. In other embodiments, only the first covering film 2601 may be provided.

[0034] In this embodiment, the support structure 300 includes a rod-shaped structure 3000, which is connected to at least one of the suture rod 2121 and the inflow end 213.

[0035] Specifically, see Figure 4The support structure 300 includes a closed structure 300a surrounded by rod-shaped structures 3000. The closed structure 300a is compressed as the stent 210 contracts radially and unfolds as the stent 210 unfolds radially, thereby making the valve prosthesis 200 more adaptable and flexible, thus adapting to the compression and release process of the valve prosthesis 200 and the process of cardiac contraction and relaxation. Furthermore, the rod-shaped structure 3000 includes a first rod 301, a second rod 302, and a third rod 303. The first rod 301, the second rod 302, the third rod 303, and the suture rod 2121 sequentially form a closed structure 300a in the same clockwise direction. At least the third rod 303 is part of the inflow end 213, allowing the support structure 300 and the inflow end 213 to share a portion of the structure. This simplifies the fabrication process of the stent 210 and reduces the number of rods, thereby reducing the compression diameter of the valve prosthesis and allowing it to enter a smaller sheath, thus reducing damage to the human body and facilitating operation. In this embodiment, two closed structures 300a are provided on the same transition portion 2601a2. These two closed structures 300a are respectively located on both sides of the suture rod 2121 and share a single suture rod 2121. In other embodiments, one or more closed structures 300a may be provided on the same transition portion 2601a2. In this embodiment, the connection point 311 of the first rod 301 and the second rod 302 is the vertex closest to the outlet end 241 in the closed structure 300a, making it easier for the closed structure 300a to be compressed or expanded as the support 210 is compressed or expanded.

[0036] In another embodiment, see Figure 9 and Figure 10 The rod-like structure 3000 includes a first rod 301 and a second rod 302. The first rod 301, the second rod 302, and the stitching rod 2121 sequentially form a closed structure 300a. At least one of the first rod 301 and the second rod 302 has a curved shape. For example, the second rod 302 includes a first rod portion 302a and a second rod portion 302b. The first rod portion 302a and the second rod portion 302b are connected to each other to form a curved shape. Simultaneously, the end where the first rod 301 connects to the second rod 302 also has a curved shape. (See reference...) Figure 10 and Figure 11 The aforementioned curved shape allows the support structure 300 to be more easily compressed as the bracket 210 contracts radially and expanded radially, resulting in greater flexibility. In this embodiment, the first rod 301 can also be part of the inflow end 213. In other embodiments, the first rod 301 and the second rod 302 are movably connected, and this mechanical connection also allows for greater flexibility in the bracket's movement.

[0037] In another embodiment, see Figure 12The support structure 300 includes support units 300b, one end of which is connected to at least one of the suture rod 2121 and the inflow end 213. The support unit 300b includes at least one free end 300b1 and a rod-like structure 3000. In this embodiment, the support units 300b are staggered on both sides of the suture rod 2121. In other embodiments, see [reference needed]. Figure 13 The support unit 300b can also be symmetrically distributed on both sides of the suture rod 2121. In one embodiment, see... Figure 14 The support unit 300b includes a Y-shape or a multi-branch shape, which can better support the transition part 2601a2, and at the same time can be more easily compressed as the support 210 contracts radially, and the closed structure unfolds as the support 210 unfolds radially.

[0038] Further, see again Figure 10 and Figure 12 The support 210 includes multiple support rods 2100. At least a portion of the rod-shaped structure 3000 of the support structure 300b has a rod diameter smaller than that of the support rod 2100, which makes the support structure 300b more deformable. This allows it to be more easily compressed as the support 210 contracts radially, and the closed structure unfolds as the support 210 unfolds radially. It also achieves the effect of supporting the transition section 2601a2.

[0039] Further, see Figures 12 to 14 In the rod-shaped structure 3000, the free end 300b1 is more flexible than other parts of the rod-shaped structure 3000, which prevents the free end from puncturing the transition part 2601a2 and improves safety. This can be achieved by making the diameter of the free end 300b1 smaller than other parts of the rod-shaped structure 3000, or by using a more flexible material for the free end 300b1.

[0040] See Figure 15 In another embodiment, the support structure 300 includes a suture rod 2121, which is fixed to the transition portion 2601a2 by a third suture 2204. The third suture 2204 has multiple cross suture points 2204a along the suture rod 2121. This method can also achieve the effect of smoothing the transition portion 2601a2, and at the same time, it does not require the design of extra rod-shaped structures.

[0041] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0042] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A valve prosthesis, comprising an inflow end and an outflow end, characterized in that, The valve prosthesis includes a support, a cover, and a leaflet assembly. The support includes an outflow end, a main body, and an inflow end connected in sequence. The main body includes a plurality of circumferentially spaced fasteners. The leaflet assembly includes a plurality of leaflets, with adjacent leaflets sewn onto the same fastener. The cover is provided at least at the inflow end. The cover includes a first cover, which is disposed on the sidewall of the support and connected to the leaflet assembly. The first cover includes a first cover connecting portion and a first cover body. The first cover connecting portion protrudes toward the outflow end. The first cover connecting portion includes a valve corner connecting portion and a transition portion connected to each other. The valve corner connecting portion is connected to the leaflet and the fastener. The transition portion connects the valve corner connecting portion and the first cover body. There is a connection between the transition portion and the valve corner connecting portion. The edge of the connection portion has a cut. The cut separates the valve corner connecting portion and the transition portion axially, so that after the valve corner connecting portion connects the leaflet and the fastener, the side of the transition portion near the connection portion has a free edge.

2. The valve prosthesis according to claim 1, characterized in that, The flap-shaped connecting portion includes a first covering portion and a second covering portion, which move towards each other to cover the fixing member. Before the first covering portion and the second covering portion move toward each other, there is a cut between the first covering portion and the transition portion, and / or, there is another cut between the second covering portion and the transition portion.

3. The valve prosthesis according to claim 1, characterized in that, The incision includes a linear incision or an open-shaped incision.

4. The valve prosthesis according to claim 2, characterized in that, The petal corner connecting portion further includes a middle portion, with the first covering portion and the second covering portion located on both sides of the middle portion. The middle portion has a window, the petal leaf includes a petal corner, and the fixing member includes multiple fixed windows that are interconnected with each other. Each fixed window includes multiple interconnected fixed window bars. The petal angle first penetrates the window from inside the bracket to outside the bracket, then penetrates the fixed window, circles around a fixed window rod, extends into the bracket again, and then penetrates the window once more. Then the first covering part and the second covering part move towards each other to cover the petal angle on the fixing member.

5. The valve prosthesis according to claim 4, characterized in that, The end of the middle portion facing the outlet is closer to the outlet than the end of the first covering portion facing the outlet, and / or the end of the middle portion facing the outlet is closer to the outlet than the end of the second covering portion facing the outlet.

6. The valve prosthesis according to claim 1, characterized in that, The leaflet and the transition portion are fixed together to form a fixing point, and the distance between the fixing point and the nearest edge of the two sides of the transition portion is at least 1 mm.

7. The valve prosthesis according to claim 1, characterized in that, A support structure is provided on the transition section, and the support structure is fixed on the transition section to smooth the surface of the transition section.

8. The valve prosthesis according to claim 7, characterized in that, The fastener includes a suture rod, the support structure includes the suture rod, the two ends of the suture rod are respectively connected to the outflow end and the inflow end, and the suture rod supports and is fixed to the surface of the transition portion.

9. The valve prosthesis according to claim 7, characterized in that, The support structure includes a rod-shaped structure, which is connected to at least one of the main body and the inflow end.

10. The valve prosthesis according to claim 9, characterized in that, The support structure includes a closed structure enclosed by the rod-shaped structure, which is compressed as the support contracts radially and unfolds as the support unfolds radially; or, the support structure includes a support unit, one end of which is connected to at least one of the main body and the inflow end, and the support unit includes at least one free end.

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