Transcatheter aortic valve integrated skirt

Abstract

The invention relates to the technical application field of transcatheter artificial heart valves, and discloses a transcatheter aortic valve integrated skirt which comprises a valve support, an inner skirt edge is arranged on the inner side of the valve support, an outer skirt edge is arranged on the outer side of the valve support, and the inner skirt edge and the outer skirt edge are manufactured through an integrated forming process. A plurality of protruding supporting bosses are arranged on the side, away from the outer skirt edge, of the inner skirt edge, a plurality of leakage-proof assemblies are arranged on the side, away from the inner skirt edge, of the outer skirt edge, and a plurality of fixing assemblies are arranged on the inner side and the outer side of the valve support. The integrated inner skirt edge and outer skirt edge are free of suture lines, the hidden danger of perivalvular leakage caused by suture gaps is fundamentally eliminated, skirt edge dislocation caused by manual operation errors is avoided, meanwhile, bulb-shaped hollowed-out grooves formed by the adjacent leakage-proof bosses form pocket-shaped spaces, trace blood breaking through attachment gaps can be actively intercepted, and the leakage-proof effect is achieved. And the use safety of the artificial valve is improved.

Description

Technical Field

[0001] This invention relates to the field of transcatheter artificial heart valve technology, specifically a transcatheter aortic valve integrated skirt. Background Technology

[0002] Heart valve disease is one of the most common cardiovascular diseases worldwide. Its core pathological features are valvular stenosis or insufficiency, which leads to cardiac hemodynamic disturbances and can cause heart failure, arrhythmia, and even death in the long term. In clinical treatment, transcatheter aortic valve replacement (TAVR) delivers a compressed artificial valve to the lesion site and releases it through a peripheral vascular approach. It does not require open-chest surgery or cardiopulmonary bypass, reducing surgical risks and patient suffering. It has become the preferred treatment option for elderly and high-risk patients with aortic valve disease.

[0003] Among the core components of transcatheter aortic valves, the valve skirt is a key component ensuring surgical efficacy and long-term safety. Its main function is to fill the anatomical gap between the artificial valve and the patient's own aortic valve annulus and vessel wall, reducing the occurrence of postoperative paravalvular leakage. Paravalvular leakage is a common postoperative complication, which can lead to heart failure in mild cases and require secondary intervention in severe cases. The valve skirt often adopts a split structure design. The inner skirt fits the inner side of the valve stent and mainly adapts to the anatomical shape of the aortic valve annulus region; the outer skirt covers the outer side of the valve stent and is used to fit the aortic vessel wall. The inner and outer skirts are connected and fixed by manual suturing or thermal bonding. The materials used are mostly polymer films with good biocompatibility and flexibility, which are adapted to the dynamic pressure environment during cardiac pulsation.

[0004] Existing methods for connecting separate valve skirts rely on manual suturing or thermal bonding. However, manual suturing is prone to errors that can lead to misalignment of the inner and outer skirts, resulting in suture gaps. Thermal bonding, on the other hand, suffers from uneven bonding strength, which increases the risk of postoperative paravalvular leakage. Manual suturing also consumes a significant amount of time, and the quality of the suturing depends on the operator's experience, making it difficult to meet the consistency requirements of large-scale production. Furthermore, the current leak-proof design of valve skirts relies on passive bonding and lacks the function of actively intercepting blood leakage. In patients with severe aortic valve annulus calcification or irregular vessel walls, it is unable to effectively cope with the leakage problem under the impact of dynamic blood flow. Summary of the Invention

[0005] To address the shortcomings of existing technologies, this invention provides a transcatheter aortic valve integrated skirt, which solves the problems of high risk of paravalvular leakage, low production efficiency, and poor large-scale consistency caused by the reliance on manual suturing or thermal fusion bonding of existing split valve skirts, as well as the fact that the leak-proof design relies solely on passive bonding and cannot cope with dynamic blood leakage in scenarios such as aortic valve annulus calcification or irregular vessel walls.

[0006] To achieve the above objectives, the present invention is implemented through the following technical solution: a transcatheter aortic valve integrated skirt, including a valve stent, an inner skirt is provided on the inner side of the valve stent, an outer skirt is provided on the outer side of the valve stent, the inner skirt and the outer skirt are made by an integrated molding process, a plurality of raised support bosses are provided on the side of the inner skirt away from the outer skirt, and a plurality of leak-proof components are provided on the side of the outer skirt away from the inner skirt; The leak-proof component includes a leak-proof protrusion, which is located on the side of the outer skirt away from the inner skirt. A hollow groove is formed between adjacent leak-proof protrusions, and an interception groove is formed on the outer side of the leak-proof protrusion. Multiple fixing components are provided on both the inner and outer sides of the valve stent for fixing the inner and outer skirts to the valve stent. Connecting components are provided on both the left and right sides of the inner and outer skirts for closing connection of the inner and outer skirts.

[0007] The integrated design of the inner and outer skirts eliminates the gaps caused by the splicing of separate skirts, reducing the risk of periocular leakage.

[0008] Preferably, the fixing component includes a positioning base, and multiple positioning bases are fixedly connected to the inner and outer sides of the valve stent. Multiple barbs are provided on the outer side of the positioning base, and multiple fixing protrusions are provided on the outer surface of the leak-proof boss and the raised support boss.

[0009] The combination of the barbs on the outside of the positioning base and the fixing protrusions eliminates the need for additional stitching or bonding processes, simplifying the assembly process of the valve stent and valve skirt.

[0010] Preferably, the barb is embedded inside the fixed protrusion and does not penetrate the other side of the fixed protrusion.

[0011] The barb is embedded only inside the fixed protrusion, which can protect the integrity of the outer side of the fixed protrusion and avoid causing local coagulation.

[0012] Preferably, the number of fixed protrusions on the inner skirt is less than the number of fixed protrusions on the outer skirt.

[0013] Among them, fewer fixation protrusions on the inner skirt can reduce the number of contact points with the valve annulus tissue, thereby reducing the risk of tissue hyperplasia after long-term implantation.

[0014] Preferably, the connecting component includes a first left seam interface and a second left seam interface. The first left seam interface is located on the left side of the outer skirt hem, and the second left seam interface is located on the left side of the inner skirt hem. A first right seam interface is located on the right side of the outer skirt hem, and a second right seam interface is located on the right side of the inner skirt hem.

[0015] Among them, the dedicated stitching interface between the outer skirt and the inner skirt can quickly distinguish the corresponding parts when assembling the inner skirt and the outer skirt, reducing manual alignment errors.

[0016] Preferably, the first left suture interface is connected to the first right suture interface, and the second left suture interface is connected to the second right suture interface.

[0017] The connection between the first left suture interface and the first right suture interface allows the outer skirt to form a continuous annular sealing surface, eliminating the risk of blood leakage at the break point at the interface.

[0018] Preferably, a fracture gap is formed between the two raised support bosses.

[0019] Among them, the non-penetrating design of the fracture gap can limit the deformation range of the inner valve skirt and prevent fatigue damage to the valve skirt material caused by excessive stretching.

[0020] Preferably, the hollowed-out groove is bulb-shaped, and the leak-proof protrusion is beacon-shaped.

[0021] Among them, the beacon-shaped anti-leakage protrusions can fill the unevenness of the blood vessel wall, forming a multi-layered seal.

[0022] This invention provides a transcatheter aortic valve integrated skirt. It has the following beneficial effects: 1. This invention features a seamless, one-piece inner and outer skirt. The inner skirt closes with the first left and first right seam interfaces, and the outer skirt closes with the second left and second right seam interfaces. This eliminates the risk of peripapillary leakage caused by suture gaps, leaving no trace of traditional sutures. At the same time, the one-piece design eliminates the need for manual alignment and sewing, avoiding skirt misalignment caused by human error and improving assembly efficiency.

[0023] 2. This invention uses barbs inserted inside the fixing protrusions without piercing them. This avoids the problems of easy detachment and damage to the skirt caused by traditional heat fusion bonding and suturing. It also ensures tight fixation of the inner skirt, outer skirt and valve stent through physical locking. At the same time, the number of fixing protrusions on the inner skirt is less than that on the outer skirt, which is suitable for the outer skirt to withstand the dynamic pressure of the blood vessel wall. The inner skirt has elastic deformation space reserved by raised support protrusions and fracture gaps. When the heart contracts and relaxes, the raised support protrusions resist collapse and the fracture gaps buffer the pressure, effectively preventing the inner and outer skirts from displacement or deformation due to dynamic pressure, and ensuring the long-term stability of the inner and outer skirts.

[0024] 3. This invention uses beacon-shaped anti-leakage protrusions to adapt to the irregular shape of the blood vessel wall, filling the tiny gaps between the stent and the blood vessel wall. At the same time, the bulb-shaped hollow groove formed by two adjacent anti-leakage protrusions creates a pocket-shaped space, actively intercepting trace amounts of blood that break through the gap. Combined with the interception groove, it further blocks the blood leakage path, forming a dual anti-leakage effect of fitting and sealing and active interception. This effect can reduce transient paravalvular leakage under dynamic cardiac pressure and improve the safety of artificial valve use. Attached Figure Description

[0025] Figure 1 This is a perspective view of the present invention; Figure 2 This is a top view of the present invention; Figure 3 This is a schematic diagram of the valve stent in this invention; Figure 4 for Figure 3 Enlarged view of point A in the middle; Figure 5 This is a schematic diagram of the inner skirt in this invention; Figure 6 This is a schematic diagram of the outer skirt in this invention; Figure 7 for Figure 6 Enlarged view of point B in the middle; Figure 8 This is a schematic diagram of the leak-proof component in this invention.

[0026] Among them, 1. Valve stent; 2. Fixation component; 21. Positioning base; 22. Barb; 23. Fixing protrusion; 3. Inner skirt; 4. Raised support protrusion; 5. Fault gap; 6. Outer skirt; 7. Leakage prevention component; 71. Leakage prevention protrusion; 72. Hollowed-out groove; 73. Intercepting groove; 8. Connecting component; 81. First left suture interface; 82. First right suture interface; 83. Second left suture interface; 84. Second right suture interface. Detailed Implementation

[0027] The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0028] Please see Figure 1-8This invention provides a transcatheter aortic valve integrated skirt, including a valve stent 1, an inner skirt 3 on the inner side of the valve stent 1, and an outer skirt 6 on the outer side of the valve stent 1. The inner skirt 3 and the outer skirt 6 are made by an integrated molding process. Multiple raised support bosses 4 are provided on the side of the inner skirt 3 away from the outer skirt 6, and multiple leak-proof components 7 are provided on the side of the outer skirt 6 away from the inner skirt 3.

[0029] Specifically, the valve stent 1 is the support carrier for the entire transcatheter aortic valve integrated skirt, providing an installation reference for the inner skirt 3 and the outer skirt 6, ensuring the corresponding position of the components. The inner skirt 3 and the outer skirt 6 adopt an integrated molding process, eliminating the gaps generated during the suturing of the separate skirts from the source, and avoiding failure caused by uneven strength at the splice. The raised support boss 4 on the inner skirt 3 directly contacts the aortic valve annulus, and supports the unfolded shape of the inner skirt 3 through its own rigidity, preventing the inner skirt 3 from collapsing due to pressure and detaching from the valve annulus during heartbeat. The leak-proof component 7 on the outer skirt 6 fits into the vessel wall area, providing support for subsequent active interception of blood leakage.

[0030] The leak-proof component 7 includes a leak-proof boss 71, which is located on the side of the outer skirt 6 away from the inner skirt 3. A hollow groove 72 is provided between adjacent leak-proof bosses 71, and an interception groove 73 is provided on the outer side of the leak-proof boss 71.

[0031] Specifically, the side of the anti-leakage protrusion 71 facing the blood vessel wall can adaptively fit according to the anatomical shape of the blood vessel wall, filling the tiny gap between the valve stent 1 and the blood vessel wall. The hollowed-out groove 72 formed between adjacent anti-leakage protrusions 71 can form an independent pocket-shaped space. When a small amount of blood breaks through the fitting surface of the anti-leakage protrusion 71, it can be temporarily stored in the pocket-shaped space to prevent the blood from flowing directly back into the heart chamber. The intercepting groove 73 on the outside of the anti-leakage protrusion 71 can change the flow direction of the leaking blood, prolong the path of the leaking blood in the anti-leakage component 7, and reduce the probability of the leaking blood breaking through the anti-leakage system.

[0032] Multiple fixing components 2 are provided on both the inner and outer sides of the valve stent 1 for fixing the inner skirt 3 and the outer skirt 6 to the valve stent 1. Connecting components 8 are provided on both the left and right sides of the inner skirt 3 and the outer skirt 6 for closing connection of the inner skirt 3 and the outer skirt 6.

[0033] Specifically, the fixation component 2 on the inner side of the valve stent 1 is specifically adapted to fix the inner skirt 3, and the fixation component 2 on the outer side is adapted to fix the outer skirt 6. The valve stent 1 divides the integrated inner skirt 3 and outer skirt 6 into two areas, inner and outer. The partitioned fixation design ensures that the inner skirt 3 and outer skirt 6 fit tightly with the valve stent 1, avoiding local loosening caused by single fixation. The connecting components 8 correspond to the left and right sides of the inner skirt 3 and outer skirt 6 respectively, which can realize the independent circumferential closure of the inner skirt 3 and outer skirt 6. This ensures the matching shape of the inner skirt 3 with the valve annulus, while also ensuring the fitting accuracy of the outer skirt 6 with the blood vessel wall, avoiding morphological deviation caused by joint closure.

[0034] The fixing component 2 includes a positioning base 21. Multiple positioning bases 21 are fixedly connected to the inner and outer sides of the valve stent 1. Multiple barbs 22 are provided on the outer side of the positioning base 21. Multiple fixing protrusions 23 are provided on the outer surface of the anti-leakage boss 71 and the raised support boss 4.

[0035] Specifically, the positioning base 21 transmits the fixing force evenly to the valve stent 1, avoiding local stress concentration that could damage the stent's mesh structure. The barbs 22 on the outer side of the positioning base 21 are distributed at an angle, which can physically lock with the fixing protrusions 23 on the anti-leakage boss 71 and the raised support boss 4, enhancing the connection strength between the fixing component 2 and the inner skirt 3 and the outer skirt 6. Furthermore, multiple fixing protrusions 23 are evenly distributed on the surfaces of the anti-leakage boss 71 and the raised support boss 4, ensuring that the force of the barbs 22 is dispersed, thus preventing damage to the skirt material due to excessive force.

[0036] The barb 22 is embedded inside the fixed protrusion 23 and does not penetrate the other side of the fixed protrusion 23.

[0037] Specifically, the barb 22 is embedded only inside the fixing protrusion 23 without penetrating it. This ensures the stability of the connection through the enveloping force inside the fixing protrusion 23, while also preventing damage to the protruding support protrusion 4 and the leak-proof protrusion 71 on the other side caused by penetration. It also prevents the formation of new blood leakage channels at the damaged area. This embedding method also preserves the elasticity of the fixing protrusion 23. When the dynamic pressure of the heart acts on the inner skirt 3 and the outer skirt 6, the fixing protrusion 23 can also slightly deform to buffer the stress, avoiding breakage caused by hard contact between the barb 22 and the protrusion.

[0038] The number of fixed protrusions 23 on the inner skirt edge 3 is less than the number of fixed protrusions 23 on the outer skirt edge 6.

[0039] Specifically, the pressure fluctuation in the aortic valve annulus region where the inner skirt 3 is attached is small, and the annulus itself provides a limiting shape. Fewer fixing protrusions 23 can meet the fixation requirements while reducing the stimulation of the annulus tissue by the fixing protrusions 23. The vessel wall region where the outer skirt 6 is attached is affected by the heart's contraction and relaxation, resulting in a large dynamic pressure change. Furthermore, the vessel wall has no limiting structure. More fixing protrusions 23 can improve the connection stability between the outer skirt 6 and the valve stent 1, preventing leakage failure caused by displacement of the outer skirt 6.

[0040] The connecting component 8 includes a first left sewing interface 81 and a second left sewing interface 83. The first left sewing interface 81 is located on the left side of the outer skirt hem 6, and the second left sewing interface 83 is located on the left side of the inner skirt hem 3. A first right sewing interface 82 is located on the right side of the outer skirt hem 6, and a second right sewing interface 84 is located on the right side of the inner skirt hem 3.

[0041] Specifically, the first left suture interface 81 and the first right suture interface 82 belong exclusively to the outer skirt edge 6, and the second left suture interface 83 and the second right suture interface 84 belong exclusively to the inner skirt edge 3. This interface design can clearly distinguish the closed components of the inner skirt edge 3 and the outer skirt edge 6, avoiding skirt edge misalignment caused by interface confusion during assembly. The first left suture interface 81 and the first right suture interface 83, the second left suture interface 82 and the second right suture interface 84 are respectively set in the flat areas of the outer skirt edge 6 and the inner skirt edge 3, which can ensure the fitting accuracy when the interface is connected, reduce the connection gap, and further reduce the risk of bleeding.

[0042] The first left suture interface 81 is connected to the first right suture interface 82, and the second left suture interface 83 is connected to the second right suture interface 84.

[0043] Specifically, after connecting the first left suture interface 81 and the first right suture interface 82, the outer skirt 6 can form a complete annular structure, tightly wrapping the outer side of the valve stent 1, ensuring that the outer skirt 6 fits the vessel wall around its entire circumference. After connecting the second left suture interface 83 and the second right suture interface 84, the inner skirt 3 can fit the inner side of the valve stent 1 to form an annulus, which is compatible with the aortic valve annulus. This achieves a double annular seal between the inner skirt 3 and the outer skirt 6, laying the foundation for the leak-proof system.

[0044] A fracture gap 5 is provided between the two raised support bosses 4.

[0045] Specifically, the fracture gap 5 mainly provides elastic deformation space for the inner skirt 3. When the patient's valve annulus has slight irregularities or the valve annulus is slightly dilated due to heart pulsation, the fracture gap 5 can buffer the stress on the inner skirt 3 through its own contraction or stretching, avoiding tearing of the inner skirt 3 due to excessive rigidity. At the same time, the fracture gap 5 does not penetrate the entire inner skirt 3, which can maintain the structural integrity of the inner skirt 3 while ensuring deformation capacity, and ensure that the basic function of the inner skirt 3 in conforming to the valve annulus is not affected.

[0046] The hollowed-out groove 72 is shaped like a light bulb, and the leak-proof protrusion 71 is shaped like a beacon tower.

[0047] Specifically, the curved bottom of the bulb-shaped hollow groove 72 can increase the space for accommodating leaked blood and improve the temporary storage capacity for leaked blood. At the same time, the curved structure can reduce the resistance to blood flow and prevent the formation of eddies caused by leaked blood, which can lead to thrombosis. The top width of the beacon-shaped anti-leakage protrusion 71 is greater than that of the bottom, which can increase the contact area with the blood vessel wall and improve the sealing effect. Moreover, the protruding top can form a physical barrier to further intercept leaked blood that breaks through the contact surface, thus strengthening the active anti-leakage performance of the anti-leakage component 7.

[0048] Working principle: When it is necessary to assemble a transcatheter aortic valve, the valve stent 1 serves as a support component. The positioning base 21 of the valve stent 1 faces the inner skirt 3, and the barb 22 is inserted into the fixing protrusion 23 on the surface of the corresponding raised support protrusion 4 of the inner skirt 3 without piercing the fixing protrusion 23 to prevent damage to the inner skirt 3. Then, the positioning base 21 on the outer side of the valve stent 1 faces the outer skirt 6, and the barb 22 pierces the fixing protrusion 23 of the leak-proof component 7 on the outer skirt 6. The mechanical locking avoids the peeling problem that is easy to occur by traditional suturing and heat fusion bonding. When it is necessary to close the circumference of the skirt, the first left suture interface 81 on the left side of the outer skirt 6 is connected to the first right suture interface 82 on the right side, and then the second left suture interface 83 on the left side of the inner skirt 3 is connected to the second right suture interface 84 on the right side, finally forming a seamless one-piece structure without any artificial suture traces.

[0049] When the valve is implanted in the human body, it is under the dynamic pressure environment of cardiac contraction and relaxation. During cardiac contraction, the blood vessel wall will compress the outer skirt 6. Since the number of fixing protrusions 23 on the outer skirt 6 is greater than that on the inner skirt 3, the fitting points of the fixing component 2 are more dense, which can resist pressure and prevent the outer skirt 6 from shifting. At the same time, the raised support protrusions 4 on the inner skirt 3 resist collapse and ensure close contact with the aortic valve annulus. During cardiac diastole, when the inner skirt 3 is subjected to stress from the relative displacement between the valve stent 1 and the valve annulus, the fracture gap 5 between the two raised support protrusions 4 will generate elastic rebound, which will buffer the stress and prevent the skirt from tearing. Furthermore, the connection between the barb 22 and the fixing protrusions 23 remains stable, preventing relative sliding between the inner skirt 3 and the outer skirt 6 and the valve stent 1, and ensuring the positional reliability of the structure throughout the cardiac cycle.

[0050] During heartbeat, there is a potential risk of blood reflux from the gap between the valve and the blood vessel wall or the valve annulus. The leak-proof protrusions 71 in the leak-proof component 7 are designed in the shape of a beacon tower. They can conform to the irregular shape of the blood vessel wall and fill the tiny gaps between the protrusions and the blood vessel wall, forming the first physical sealing barrier to prevent the initial backflow of blood. When a small amount of blood breaks through the first barrier, the bulb-shaped hollow grooves 72 formed between adjacent leak-proof protrusions 71 will form a closed pocket-shaped space, actively intercepting the leakage and preventing it from spreading. At the same time, the interception grooves 73 further block the leakage path, finally forming a triple leak-proof system to reduce the risk of paravalvular leakage.

Claims

1. A transcatheter aortic valve integrated skirt, comprising a valve stent (1), characterized in that, The valve stent (1) has an inner skirt (3) on its inner side and an outer skirt (6) on its outer side. The inner skirt (3) and the outer skirt (6) are made by an integrated molding process. The inner skirt (3) has multiple raised support bosses (4) on the side away from the outer skirt (6) and the outer skirt (6) has multiple leak-proof components (7) on the side away from the inner skirt (3). The leak-proof component (7) includes a leak-proof boss (71), which is located on the side of the outer skirt (6) away from the inner skirt (3). A hollow groove (72) is provided between adjacent leak-proof bosses (71), and an interception groove (73) is provided on the outside of the leak-proof boss (71). Multiple fixing components (2) are provided on the inner and outer sides of the valve stent (1) for fixing the inner skirt (3) and outer skirt (6) to the valve stent (1). Connecting components (8) are provided on the left and right sides of the inner skirt (3) and outer skirt (6) for closing connection of the inner skirt (3) and outer skirt (6).

2. The transcatheter aortic valve integrated skirt according to claim 1, characterized in that, The fixing component (2) includes a positioning base (21), and multiple positioning bases (21) are fixedly connected to the inner and outer sides of the valve stent (1). Multiple barbs (22) are provided on the outer side of the positioning base (21), and multiple fixing protrusions (23) are provided on the outer surface of the anti-leakage boss (71) and the raised support boss (4).

3. The transcatheter aortic valve integrated skirt according to claim 2, characterized in that, The barb (22) is embedded inside the fixed protrusion (23) and does not penetrate the other side of the fixed protrusion (23).

4. The transcatheter aortic valve integrated skirt according to claim 1, characterized in that, The number of fixed protrusions (23) on the inner skirt (3) is less than the number of fixed protrusions (23) on the outer skirt (6).

5. The transcatheter aortic valve integrated skirt according to claim 1, characterized in that, The connecting component (8) includes a first left suture interface (81) and a second left suture interface (83). The first left suture interface (81) is located on the left side of the outer skirt edge (6), and the second left suture interface (83) is located on the left side of the inner skirt edge (3). A first right suture interface (82) is located on the right side of the outer skirt edge (6), and a second right suture interface (84) is located on the right side of the inner skirt edge (3).

6. The transcatheter aortic valve integrated skirt according to claim 5, characterized in that, The first left suture interface (81) is connected to the first right suture interface (82), and the second left suture interface (83) is connected to the second right suture interface (84).

7. The transcatheter aortic valve integrated skirt according to claim 1, characterized in that, A fracture gap (5) is provided between the two raised support bosses (4).

8. The transcatheter aortic valve integrated skirt according to claim 1, characterized in that, The hollowed-out groove (72) is bulb-shaped, and the leak-proof protrusion (71) is beacon-shaped.

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