Transcatheter aortic valve X-type valve leaflet valve frame and connecting method thereof

Abstract

The invention relates to the field of medical instruments, and discloses a transcatheter aortic valve X-type valve leaflet valve frame and a connecting method thereof.The transcatheter aortic valve X-type valve leaflet valve frame comprises a first supporting frame, a second supporting frame and a valve leaflet structure, a plurality of X-type windows are formed between the first supporting frame and the second supporting frame, and the first supporting frame and the second supporting frame form an annular frame structure; the number of the valve leaflet structures is three, the valve leaflet structures are all arranged in the annular frame structure, a plurality of connecting structures are arranged at the joint of the first supporting frame and the second supporting frame and used for connecting and fixing the valve leaflet structures, and each connecting structure comprises a connecting block. By means of the arranged connecting lugs, stress isolation is achieved, the X-shaped suture structure is adopted, the connecting lugs are locked from multiple dimensions, complex stress from blood flow impact is effectively resisted and dispersed, the pain point that stress of a traditional valve suture point is concentrated, and valve leaflet tearing or fatigue failure is likely to be caused is solved, and the suture effect is improved. Therefore, the anti-fatigue performance and the long-term structural integrity of the valve are enhanced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a X-shaped leaflet frame of a transcatheter aortic valve and a connecting method thereof. BACKGROUND

[0002] Heart valve disease is an important part of cardiovascular disease. The traditional treatment methods mainly include drug therapy and surgical valve replacement. Drug therapy can only relieve symptoms and cannot cure valve lesions. Surgical valve replacement has good effect, but has the disadvantages of large trauma, high risk and long recovery time. It is difficult for elderly patients, patients with multiple diseases or weak patients to tolerate.

[0003] Early artificial heart valves are mainly divided into two categories: mechanical valves and biological valves. Mechanical valves have the advantage of strong durability, but have the risk of thrombosis, and patients need lifelong anticoagulant therapy. Biological valves have good biocompatibility and do not need long-term anticoagulation, but have the problems of relatively poor durability and easy calcification. Compared with traditional surgical operation, transcatheter artificial heart valve technology has the advantages of small trauma, fast recovery and fewer complications. It is a technology that delivers an artificial valve to the diseased valve position through a catheter without thoracotomy and extracorporeal circulation support, reducing the risk of surgery and the pain of patients. At present, transcatheter artificial heart valve technology is still developing and innovating.

[0004] In the prior art, flexible biological leaflets are directly sewn to rigid metal frame support columns. In the billions of heartbeats, the leaflets need to withstand high-frequency opening and closing movements and huge blood flow impact forces. These mechanical stresses will concentrate on the sewing holes and the surrounding biological tissues, so that the fragile leaflet tissue is prone to micro-tears under repeated stretching, bending and shearing, and will accumulate over time to develop into macro-leaflet tears or shedding, ultimately leading to valve failure. The existing valve sewing point stress concentration has the pain point of being prone to cause leaflet tearing or fatigue failure, thereby reducing the fatigue resistance and long-term structural integrity of the valve. SUMMARY

[0005] In view of the deficiencies of the prior art, the present application provides a X-shaped leaflet frame of a transcatheter aortic valve and a connecting method thereof, which solves the pain point of stress concentration at the traditional valve sewing point, which is prone to cause leaflet tearing or fatigue failure, thereby reducing the fatigue resistance and long-term structural integrity of the valve.

[0006] To achieve the above object, the application is implemented by the following technical solutions: the application provides an X-shaped valve leaflet frame of a transcatheter aortic valve, comprising a first support frame, a second support frame and valve leaflet structures, a plurality of X-shaped windows are formed between the first support frame and the second support frame, the first support frame and the second support frame form an annular frame structure, and the valve leaflet structures are arranged inside the annular frame structure; A plurality of connecting structures are arranged at the connecting position of the first support frame and the second support frame, for connecting and fixing the valve leaflet structures, the connecting structure comprises a connecting block, a connecting port is arranged on the side of the connecting block close to the valve leaflet structure, connecting grooves are arranged on the two sides of the connecting port, and circular holes are symmetrically arranged on the outer side of the connecting block.

[0007] The X-shaped valve leaflet frame of the transcatheter aortic valve comprises an annular frame structure formed by the first support frame and the second support frame, and three valve leaflet structures uniformly and separately arranged inside the annular frame structure, the annular frame structure preferably adopts a medical metal material with super-elasticity and shape memory effect, and in the present scheme, the annular frame structure is made of nickel-titanium alloy, so that the annular frame structure formed by the first support frame and the second support frame can be compressed and loaded into a small delivery catheter, and after reaching the target position, it can automatically expand and restore the preset shape at body temperature.

[0008] Preferably, the circular holes are vertically arranged, the valve leaflet structures are connected with the connecting blocks through sutures, and recesses are formed at the connecting position of the first support frame and the second support frame.

[0009] Preferably, the valve leaflet structure comprises a fan-shaped valve leaflet, and connecting ears are arranged on the two sides of the fan-shaped valve leaflet.

[0010] Preferably, a connecting port is arranged on the side of the connecting block close to the center of the valve, and connecting grooves are further extended on the two sides of the connecting block, and the composite structure forms two symmetrical guide rails for guiding the penetration and positioning of the connecting ears, so as to ensure the consistency of the position of the valve leaflet before suturing and avoid assembly errors. Preferably, a first connecting part is arranged at the top of the connecting position of the connecting ear and the fan-shaped valve leaflet, a second connecting part is arranged at the connecting position of the connecting ear and the vertical part of the fan-shaped valve leaflet, and a third connecting part is arranged at the connecting position of the connecting ear and the arc part of the fan-shaped valve leaflet.

[0011] Preferably, the fan-shaped valve leaflets are connected through sutures, and four vertical sutures are arranged between the second connecting part and the first connecting part.

[0012] Preferably, four horizontal knot-type sutures are arranged between the second connecting part and the third connecting part, and the spacing between the four sutures is millimeters.

[0013] The vertical arrangement of the circular holes is to cooperate with the subsequent suturing operation, the vertically arranged holes define the path of the suture line, and ensure that the pulling force of the suture line can be effectively transmitted when the preliminary fixation is carried out, so as to pull the leaflet assembly vertically downward and anchor it.

[0014] Preferably, the connecting ears pass through the connecting port and the connecting groove respectively, and the connecting ears can wrap the outside of the connecting block.

[0015] Another aspect of the present application provides a connecting method of a trans-catheter aortic valve X-shaped leaflet valve frame, comprising the following steps: S1, suturing the leaflets: aligning two by two three fan-shaped leaflets, first performing serpentine suturing in the area from the second connecting part to the first connecting part, and then performing knotting suturing downward along the vertical part, so as to connect the three fan-shaped leaflets into one.

[0016] S2, fixing the valve frame: placing the joint of the fan-shaped leaflet into the connecting port of the connecting block, and passing the reserved suture line from the lower circular hole, returning after passing around the recess, and then passing out, and tightening the suture line to complete the preliminary fixation.

[0017] S3, wrapping the suture: folding and wrapping the connecting ears around the connecting block, forming an X-shaped suture structure by alternately suturing horizontal needles and inclined needles and changing directions, and finally fixing the connecting ears on the connecting block.

[0018] The present application provides a trans-catheter aortic valve X-shaped leaflet valve frame and a connecting method thereof. The present application has the following beneficial effects: 1. The connecting ears of the present application separate the structure area bearing the suture stress from the leaflet body performing the function, realize stress isolation, and finally adopt an X-shaped suture structure, which can lock the connecting ears from multiple dimensions, effectively resist and disperse the complex stress from the blood flow impact, solve the pain points of stress concentration at the traditional valve suture point, which easily leads to leaflet tearing or fatigue failure, thereby enhancing the fatigue resistance and long-term structural integrity of the valve.

[0019] 2. The present application defines the first connecting part, the second connecting part and the third connecting part on the leaflet, and sets the connecting port, the connecting groove and the circular hole on the valve frame, converts the traditional manual suture process which depends on the experience of the operator and is subjective into a repeatable standardized industrial process, thereby ensuring that each product has high consistency in the key connecting structure, and guaranteeing the stability and reliability of the product quality.

[0020] 3、The application uses the recess as an anchoring point of the suture line, and the operator only needs to perform simple threading and tightening actions to complete the preliminary fixation of the leaflet and the frame, and the fixation effect is firm, which simplifies the process, shortens the assembly time, reduces the dependence on the high-level skills of the operator, and thus helps to improve the production efficiency and reduce the manufacturing cost.

[0021] 4、The application adopts different stitching strategies in different stitching areas, adopts serpentine stitching at the top of the elastic leaflet junction, and adopts knotting stitching at the main body connection of the leaflet that needs absolute safety locking, so that the whole leaflet structure has flexibility to adapt to deformation and safety to prevent failure, and the structural mechanical properties are optimized. BRIEF DESCRIPTION OF DRAWINGS

[0022] Figure 1 is a perspective view of the application; Figure 2 is a schematic view of the leaflet structure in the application; Figure 3 is a schematic view of the connecting ear in the application; Figure 4 is a schematic view of the suture line in the application; Figure 5 is Figure 3 is an enlarged view of A in the application; Figure 6 is a schematic view of the circular hole in the application; Figure 7 is a schematic view of the connecting port in the application; Figure 8 is a schematic view of the connecting block in the application.

[0023] 1, first support frame; 2, second support frame; 3, leaflet structure; 31, fan-shaped leaflet; 32, connecting ear; 33, first connecting part; 34, second connecting part; 35, third connecting part; 4, connecting structure; 41, connecting block; 42, connecting port; 43, connecting slot; 44, circular hole; 45, suture line; 46, recess. DETAILED DESCRIPTION

[0024] The technical solutions in the embodiments of the application will be described in detail below with reference to the drawings of the application specification. Obviously, the described embodiments are only part of the embodiments of the application, not all embodiments. Based on the embodiments in the application, all other embodiments obtained by those skilled in the art without creative labor are within the scope of protection of the application.

[0025] Reference is made to the drawings Figures 1-2The application provides a trans-catheter aortic valve X-shaped leaflet frame. The connecting structure 4 comprises a connecting block 41, a connecting port 42 is formed on one side of the connecting block 41 close to the leaflet structure 3, connecting grooves 43 are formed on the two sides of the connecting port 42, and circular holes 44 are symmetrically arranged on the outer side of the connecting block 41.

[0026] Specifically, the trans-catheter aortic valve X-shaped leaflet frame comprises a ring-shaped frame structure formed by the first support frame 1 and the second support frame 2 and three leaflet structures 3 uniformly and separately arranged in the ring-shaped frame structure, the ring-shaped frame structure is preferably made of a medical metal material with super-elasticity and shape memory effect, and in the present scheme, the ring-shaped frame structure is made of nickel-titanium alloy, so that the ring-shaped frame structure formed by the first support frame 1 and the second support frame 2 can be compressed and loaded into a small delivery catheter and automatically expanded and restored to a preset shape at body temperature after reaching the target position, the first support frame 1 and the second support frame 2 are interwoven together through laser cutting to form a plurality of stable X-shaped windows, the geometric configuration of the X-shaped window not only provides radial support for the frame, but also ensures the consistency and stability of the frame in the radial compression and expansion process.

[0027] Reference is made to the accompanying drawings Figures 3-5 The circular holes 44 are vertically arranged, the leaflet structure 3 is connected with the connecting block 41 through a suture 45, and a recess 46 is formed at the connecting position of the first support frame 1 and the second support frame 2.

[0028] Specifically, in order to solve the long-term reliability problem of the connection between the leaflet and the frame, the application designs the connecting structure 4, and the core of each connecting structure 4 is the connecting block 41, which serves as a connecting component of the ring-shaped frame structure formed by the first support frame 1 and the second support frame 2 and the fan-shaped leaflet 31.

[0029] On one side of the connecting block 41 close to the center of the valve, the connecting port 42 is formed, and the connecting grooves 43 are further extended on the two sides of the connecting block 41, the composite structure forms two symmetrical guide rails for guiding the penetration and positioning of the connecting lug 32, and the position consistency before the leaflet is sutured is ensured, and assembly errors are avoided.

[0030] On the outer side of the connecting block 41, two circular holes 44 arranged vertically are symmetrically arranged, which provide a preset suture path for the subsequent suture step, and the position and vertical arrangement are the basis for realizing the preliminary fixation suture operation, which ensures the uniformity and repeatability of the stress of each needle.

[0031] Referring to the drawings Figures 6-8 Above the connecting block 41, a recess 46 is formed at the connection of the first support frame 1 and the second support frame 2, and the suture line 45 can surround the recess 46 during subsequent suturing to form a mechanically stable fixed knot, thereby enhancing the reliability of the preliminary fixation and preventing the suture line from loosening during subsequent operations.

[0032] The leaflet structure 3 includes a fan-shaped leaflet 31, and connecting ears 32 are arranged on both sides of the fan-shaped leaflet 31. The connecting ears 32 are provided with first connecting portions 33 at the top of the connecting portions of the fan-shaped leaflet 31, second connecting portions 34 are arranged at the connecting portions of the vertical portions of the fan-shaped leaflet 31, and third connecting portions 35 are arranged at the connecting portions of the arc portions of the fan-shaped leaflet 31.

[0033] Each two fan-shaped leaflets 31 are connected by a suture line 45, and four needles are vertically sutured between the second connecting portion 34 and the first connecting portion 33 by the suture line 45.

[0034] The vertical arrangement of the circular hole 44 is to cooperate with the subsequent suture operation, and the vertically arranged hole defines the path of the suture line 45, which ensures that the force of pulling the suture line can be effectively transmitted when performing preliminary fixation, so as to pull the leaflet assembly vertically downward and anchor it.

[0035] The suture line 45 is made of medical polymer, and the present scheme uses PTFE non-absorbable suture line 45 for connection. The suture connection method has good flexibility and strength, can buffer the impact of blood flow, and avoid stress concentration and tissue tearing caused by rigid connection.

[0036] Specifically, the leaflet structure 3 is the core of the valve to realize the function of the one-way valve, and the main body of the leaflet structure 3 is a fan-shaped leaflet 31, which is preferably made of specially anti-calcification treated bovine pericardium or porcine pericardium tissue, to ensure the long-term biocompatibility and durability of the fan-shaped leaflet 31.

[0037] On both sides of the fan-shaped leaflet 31, the connecting ears 32 are integrally arranged. This design separates the functional area of the leaflet from the connecting area. The connecting ear 32 as a special stress part can concentrate the suture stress, thereby protecting the main body of the fan-shaped leaflet 31 from stress concentration and improving the fatigue life of the valve.

[0038] In order to realize the standardization of the suturing process, three mark points are defined on the fan-shaped leaf 31, that is, the first connecting part 33, the second connecting part 34 and the third connecting part 35, and the three points constitute the way points of the suturing operation, so that the operator can quickly and accurately complete the suturing work of the fan-shaped leaf 31.

[0039] The second connecting part 34 to the third connecting part 35 is transversely knotted and sutured by four needles with a spacing of 1mm between the four needles.

[0040] Specifically, the fan-shaped leaf 31 is a functional main body of the valve for realizing the one-way blood flow control, and the fan-shaped geometry of the fan-shaped leaf 31 is optimized by fluid mechanics, so as to ensure that when closed, the fan-shaped leaf 31 can form sufficient coaptation area with other fan-shaped leaf 31, effectively prevent blood backflow, and when opened, the fan-shaped leaf 31 can form the maximum effective valve orifice area, thereby reducing the transvalvular pressure difference.

[0041] The connecting lug 32 can wrap the outside of the connecting block 41 by penetrating the connecting port 42 and the connecting groove 43.

[0042] Another aspect of the present application provides a connecting method of the X-shaped leaf valve frame of the transcatheter aortic valve, comprising the following steps: S1, suturing the leaf: aligning the three fan-shaped leaves 31 two by two, first performing serpentine suturing in the area from the second connecting part 34 to the first connecting part 33, and then performing knotting suturing downward along the vertical part, so as to connect the three fan-shaped leaves 31 into one.

[0043] Specifically, the S1 step adopts a zoned optimization suturing mode, the serpentine suturing is adopted in the high-stress and elastic fan-shaped leaf 31 junction top area, the knotting suturing is adopted in the leaf body connecting area which needs absolute firmness and prevents the suture from disintegration, and the combined suturing scheme fully considers the mechanical requirements of different areas of the fan-shaped leaf 31, and is a process embodiment for realizing high performance and high reliability of the valve.

[0044] S2, fixing the valve frame: the joint of the fan-shaped leaf 31 is placed in the connecting port 42 of the connecting block 41, the reserved suture line 45 is penetrated from the lower circular hole 44, returned and penetrated out after passing through the recess 46, and the suture line 45 is tightened to complete the preliminary fixation.

[0045] The S2 step is a self-locking anchoring process, the path of the suture line forms a tightening belt structure by using the recess 46 as a lever fulcrum, and the operator only needs to simply tighten the suture line to generate mechanical advantage, so as to firmly and accurately pull the leaf structure 3 into the preset position and lock, which simplifies the assembly difficulty and improves the assembly efficiency and consistency.

[0046] S3, package suture: the connecting lug 32 is folded to wrap the connecting block 41, and the X-shaped suture structure is formed by alternately sutured horizontal needle and oblique needle and changing direction, so as to complete the final fixation of the connecting lug 32 on the connecting block 41.

[0047] Specifically, the alternately horizontal needle and oblique needle constructs a dense suture net, and the most critical is to form an X-shaped suture structure. The X-shaped structure is stable in engineering, and can resist tensile and shear forces from multiple directions at the same time. Applying this structure to the fixation of the connecting lug 32 means that no matter which angle the blood flow impacts the fan-shaped leaflet 31, the stress generated can be effectively decomposed and borne by the X-shaped suture structure.

[0048] Working principle: align the three fan-shaped leaflets 31 two by two, and suture the serpentine horizontal needle back and forth between the second connecting part 34 and the first connecting part 33; then, vertically downward from the second connecting part 34, suture to the third connecting part 35 by knotting suture, so as to connect the three independent fan-shaped leaflets 31 into a complete leaflet combination.

[0049] Place the junction of adjacent leaflets of the leaflet combination in the connecting block 41, and pass the reserved suture line 45 into the circular hole 44 of the connecting block 41; start from the circular hole 44 below, suture two needle serpentine horizontal needle, make the suture line pass through the circular hole 44 above and surround to the recess 46 of the frame, then suture two needle serpentine horizontal needle from the inside of the frame and pass out from the circular hole 44 below, tighten the suture line 45 to realize the preliminary fixation of the leaflet combination and the frame.

[0050] Fold the separated connecting lug 32 to wrap the connecting block 41, suture a horizontal needle from below the frame and tighten; then, alternately suture horizontal needle and oblique needle to the right and upward above the horizontal needle; when sutured to the third horizontal needle, change the direction, suture two oblique needles downward and to the right from the frame, so as to form two X-shaped suture structures with the previous oblique needles, thereby completing the final connection and fixation.

Claims

1. A transcatheter aortic valve X-leaflet frame, characterized in that, The application relates to a kind of X-shaped leaflet valve frame of transcatheter aortic valve, comprising first support frame (1), second support frame (2) and leaflet structure (3), multiple X-shaped windows are formed between the first support frame (1) and the second support frame (2), the first support frame (1) and the second support frame (2) form a ring frame structure, and the leaflet structure (3) is provided with three and is arranged inside the ring frame structure. Multiple connection structures (4) are arranged at the connection of the first support frame (1) and the second support frame (2), for connecting and fixing the leaflet structure (3), the connection structure (4) comprises a connecting block (41), a connecting port (42) is arranged on the side of the connecting block (41) close to the leaflet structure (3), connecting grooves (43) are arranged on the two sides of the connecting port (42), and circular holes (44) are symmetrically arranged on the outer side of the connecting block (41).

2. A transcatheter aortic valve X-leaflet frame according to claim 1, characterized in that, The circular holes (44) are vertically arranged, the leaflet structure (3) is connected to the connecting block (41) through a suture line (45), and a recess (46) is formed at the connection of the first support frame (1) and the second support frame (2).

3. A transcatheter aortic valve X-leaflet frame according to claim 2, wherein, The leaflet structure (3) comprises a fan-shaped leaflet (31), and connecting ears (32) are arranged on the two sides of the fan-shaped leaflet (31).

4. A transcatheter aortic valve X-leaflet frame according to claim 3, wherein, First connecting portions (33) are arranged on the top of the connecting ears (32) at the connection of the connecting ears (32) and the fan-shaped leaflet (31), second connecting portions (34) are arranged at the connection of the connecting ears (32) and the vertical part of the fan-shaped leaflet (31), and third connecting portions (35) are arranged at the connection of the connecting ears (32) and the arc part of the fan-shaped leaflet (31).

5. A transcatheter aortic valve X-leaflet frame according to claim 4, wherein, The first connecting portions (33) and the second connecting portions (34) are on the same vertical line.

6. A transcatheter aortic valve X-leaflet frame valve according to claim 3, wherein, The fan-shaped leaflets (31) are connected through the suture line (45).

7. The transcatheter aortic valve X-leaflet frame of claim 4, wherein, The second connecting portions (34) and the first connecting portions (33) are vertically sutured through the suture line (45).

8. The transcatheter aortic valve X-leaflet frame of claim 4, wherein, The second connecting portions (34) and the third connecting portions (35) are transversely knotted sutured through the suture line (45), and the spacing between the four needles is 1mm.

9. The transcatheter aortic valve X-leaflet frame of claim 3, wherein, The connecting ears (32) pass through the connecting port (42) and the connecting groove (43) respectively, and the connecting ears (32) can wrap the outer side of the connecting block (41). 10.A connection method of X-shaped leaflet valve frame of transcatheter aortic valve, applied to the X-shaped leaflet valve frame of transcatheter aortic valve in any one of claims 1-9, characterized in that, S1, suture leaflet: aligning the three fan-shaped leaflets (31) two by two, first suture in the area from the second connecting portion (34) to the first connecting portion (33) in a snakelike manner, and then suture in a knotted manner along the vertical part, so that the three fan-shaped leaflets (31) are connected into one body; S2, fix the valve frame: the joint of the fan-shaped leaflet (31) is placed into the connecting port (42) of the connecting block (41), the suture line (45) is passed from the lower circular hole (44), returned and passed out after passing around the recess (46), and the suture line (45) is tightened to complete preliminary fixation. S3, package suture: the connecting lug (32) is folded and wrapped around the connecting block (41), and the connecting lug (32) is sutured on the connecting block (41) by alternately suture horizontal needles and inclined needles and changing directions to form an X-shaped suture structure to complete the final fixation.

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