A suture assembly for a prosthetic heart valve and a prosthetic heart valve

Abstract

The application provides a sewing assembly for an artificial heart valve and an artificial heart valve, wherein an outer wall of a valve ring of the artificial heart valve is provided with a groove in a circumferential direction, and the groove has an inwardly inclined slope; the sewing assembly comprises a sewing film and a clasp, the sewing film is used for connecting a human native tissue, the clasp is used for fixing the sewing film to the valve ring and allowing the valve ring to rotate along the clasp; the sewing film at least comprises an inner fixing part and an outer sewing part, the inner fixing part is between the valve ring and the clasp and is tightly attached to the groove, and the outer sewing part is connected with the inner fixing part and covers the clasp; the clasp is a hollow columnar structure, and an end part of the clasp has a self-locking slope which is formed by being inwardly bent; when the clasp is clamped in the groove, the self-locking slope abuts against the slope of the groove after abutting against the inner fixing part. The application optimizes the structure, reduces the torque required when actively rotating the valve, facilitates the adjustment of the valve angle, increases the pre-tightening force on the valve ring when the valve ring is intervened by external force, more firmly fixes the valve ring, and prevents uncontrollable rotation of the valve ring.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to a suture assembly for an artificial heart valve and an artificial heart valve. Background Technology

[0002] Implantable artificial heart valves are typically one-way valves, allowing blood to flow through while preventing backflow. Before implantation and fixation, the valve leaflet opening direction must be carefully determined to achieve the most effective hemodynamics, while ensuring that the opening and closing of the leaflets is not affected by surrounding heart tissue. Because the valve's position cannot be adjusted once sutured, and adjusting its position before fixation is a relatively complex surgical procedure.

[0003] Some existing artificial heart valves, even after being secured by suture components, can still be manually rotated. However, this manual rotation requires a sufficiently small torque to avoid damaging surrounding tissues. Furthermore, even after implantation and external forces, the friction generated by the suture components gripping the valve annulus must be sufficiently large to prevent unnecessary rotation of the annulus within the body. Current technologies often suffer from excessively high torque during rotation or inadequate clamping of the suture components after implantation.

[0004] Therefore, it is necessary to design a suture assembly for artificial heart valves and an artificial heart valve containing the assembly to reduce the torque required when actively rotating the valve and to increase the preload on the valve annulus when subjected to external force intervention. Summary of the Invention

[0005] This invention provides a suture assembly for artificial heart valves, which optimizes the structure, reduces the torque required for active valve rotation, and facilitates valve angle adjustment; it also increases the preload on the valve annulus when subjected to external force, more reliably fixing the valve annulus and preventing uncontrollable rotation of the valve annulus.

[0006] This invention provides a suture assembly for an artificial heart valve. The outer wall of the valve annulus of the artificial heart valve has a groove along its circumference, and the groove has an inwardly inclined slope. The suture assembly includes a suture membrane and a retaining ring. The suture membrane is used to connect the original human tissue, and the retaining ring is used to fix the suture membrane to the valve annulus and allow the valve annulus to rotate along the retaining ring. The suture membrane includes at least an internal fixation part and an external suture part. The internal fixation part is located between the valve annulus and the retaining ring and is close to the groove. The external suture part is connected to the internal fixation part and covers the retaining ring. The retaining ring has a hollow columnar structure, and the end of the retaining ring has an inwardly bent self-locking slope. When the retaining ring is engaged in the groove, the self-locking slope abuts against the slope of the groove after adhering to the internal fixation part.

[0007] Preferably, the axial width of the groove gradually decreases radially from the inside to the outside, such that the upper end face and / or lower end face of the groove are inwardly inclined first and / or second inclined surfaces; the top and / or bottom end of the retaining ring is bent inward to form a first self-locking inclined surface and / or a second self-locking inclined surface that matches the first and / or second inclined surfaces.

[0008] Preferably, one end of the external suture is connected to one end of the internal fixation part, and the other end of the external suture extends away from the valve annulus and is connected to the other end of the internal fixation part, so as to completely cover the retaining ring.

[0009] Preferably, the inner edge of the top of the retaining ring is bent downwards and then bent inwards and upwards to form a first self-locking slope; when the retaining ring is in its natural state, the angle between the first self-locking slope and the vertical plane is α1.

[0010] Preferably, the angle between the first inclined surface and the vertical plane is β1. When the retaining ring is engaged in the groove, the angle between the first self-locking inclined surface and the vertical plane is β1, β1 > α1, and the first self-locking inclined surface applies a preload force to the first inclined surface.

[0011] Preferably, the inner edge of the bottom end of the retaining ring is bent upward and then bent inward and downward to form a second self-locking slope; when the retaining ring is in its natural state, the angle between the second self-locking slope and the vertical plane is α2.

[0012] Preferably, the angle between the second inclined plane and the vertical plane is β2. When the retaining ring is engaged in the groove, the angle between the second self-locking inclined plane and the vertical plane is β2, where β2 > α2, and the second self-locking inclined plane applies a preload force to the second inclined plane.

[0013] Preferably, the outer wall of the retaining ring is provided with a plurality of V-shaped grooves, which are spaced apart along the axial direction and are arranged circumferentially around the outer wall of the retaining ring; when external pressure is applied to the retaining ring, the V-shaped grooves are compressed and the height of the retaining ring decreases; at the same time, the first self-locking inclined surface and / or the second self-locking inclined surface are respectively flipped outward, thereby increasing the inner diameter of the retaining ring.

[0014] Preferably, when radial external pressure is applied to the retaining ring, the angle between the first self-locking inclined plane flipping outward and the vertical plane is ϒ1, where ϒ1 < α1.

[0015] Preferably, when radial external pressure is applied to the retaining ring, the angle between the second self-locking inclined plane flipping outward and the vertical plane is ϒ2, where ϒ2 < α2.

[0016] Preferably, the retaining ring is made of an elastic material with good biocompatibility.

[0017] Based on the same concept, the present invention also provides an artificial heart valve, including the above-described suture assembly for an artificial heart valve.

[0018] Compared with the prior art, the technical solutions of the embodiments of the present invention have beneficial effects.

[0019] For example, the present invention adjusts the connection structure of the valve annulus and the retaining ring, setting the upper and / or lower end surfaces of the groove on the outer wall of the valve annulus as inwardly inclined first and / or second inclined surfaces; the top and / or bottom ends of the retaining ring are bent inward to form a first self-locking inclined surface and / or a second self-locking inclined surface; when the retaining ring is engaged in the groove, the first and / or second self-locking inclined surfaces respectively abut against the inner fixing part and then abut against the first and / or second inclined surfaces; the retaining ring provides sufficient support for the valve annulus, and due to the change in the contact surface, the torque required to manually rotate the valve annulus is greatly reduced; when an external force intervenes radially outward, the positive pressure of the retaining ring on the suture membrane and valve annulus is increased, the friction is increased, the valve annulus is more securely fixed, and uncontrollable rotation of the valve annulus is prevented; For example, the outer wall of the retaining ring is provided with a V-shaped groove to achieve radial compression during the installation of the retaining ring. Through its elastic deformation, it provides sufficient preload after being installed in the groove of the valve ring. The retaining ring simultaneously performs the dual functions of preload and self-locking: the preload is provided by the elastic deformation of the retaining ring, and the self-locking force is enhanced by the wedge effect of the self-locking inclined surface under the action of external force. Both functions are achieved by the same component, eliminating the need for additional locking parts and simplifying the structure. Attached Figure Description

[0020] Figure 1 This is a cross-sectional view of the suture assembly for an artificial heart valve installed on the valve frame in an embodiment of the present invention; Figure 2 yes Figure 1 Enlarged view of point A in the middle; Figure 3 This is a schematic diagram comparing the size of the retaining ring in its natural state with the size of the groove in an embodiment of the present invention; Figure 4 This is a schematic diagram of the compression process during the installation of the retaining ring in an embodiment of the present invention; Figure 5 This is a partial schematic diagram of the compression process during the installation of the retaining ring in an embodiment of the present invention; Figure 6 This is a schematic diagram of the compression of the first self-locking inclined plane of the retaining ring in an embodiment of the present invention; Figure 7 This is a schematic diagram of force decomposition of the suture assembly for an artificial heart valve in an embodiment of the present invention when subjected to external force; Figure 8 This is a schematic diagram of a suture assembly in the prior art when subjected to external force.

[0021] Explanation of reference numerals in the attached figures: 1-Lobe ring; 2-Snap ring; 21-First self-locking inclined surface; 22-Second self-locking inclined surface; 23-V-groove; 3-Suture membrane; 31-Internal fixation part; 32-External suture part; 4-Spring retaining ring; 5-Cap ring. Detailed Implementation

[0022] To make the objectives, features, and beneficial effects 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. It is to be understood that the specific embodiments described below are merely for explaining the present invention and are not intended to limit the present invention. Furthermore, the same or similar reference numerals may be used in the figures to refer to the same or similar elements in different embodiments, and descriptions of the same or similar elements in different embodiments, as well as descriptions of prior art elements, features, effects, etc., may be omitted. It should be noted that the axial, radial, and circumferential directions mentioned in the embodiments of the present invention represent the axial, radial, and circumferential directions of the petiole ring 1, respectively.

[0023] Reference Figures 1 to 6 This invention provides a suture assembly for an artificial heart valve and an artificial heart valve comprising the assembly.

[0024] In a specific embodiment, the artificial heart valve includes a valve annulus 1, leaflets, and a suture assembly. The valve annulus 1, serving as the overall supporting framework, has a pre-defined annular contour and is used to support the leaflets and maintain the basic shape of the valve opening. The leaflets are fixed to the inner side of the valve annulus 1 and can periodically open and close under blood flow pressure to simulate the unidirectional blood flow function of a natural heart valve. The suture assembly is connected to the outer edge of the valve annulus 1 and is used to firmly suture the entire artificial heart valve to the patient's own valve annulus tissue or adjacent cardiovascular structures, ensuring long-term stability and sealing after implantation. These components work together to achieve the function of the artificial heart valve.

[0025] In some embodiments, the outer wall of the valve annulus 1 of the artificial heart valve is provided with a groove along the circumferential direction, the groove having an inwardly inclined slope; the suture assembly includes a suture membrane 3 and a retaining ring 2, the suture membrane 3 is used to connect the original human tissue, the retaining ring 2 is used to fix the suture membrane 3 to the valve annulus 1 and allow the valve annulus 1 to rotate along the retaining ring 2; the suture membrane 3 includes at least an internal fixation part 31 and an external suture part 32, the internal fixation part 31 is located between the valve annulus 1 and the retaining ring 2 and is in close contact with the groove, the external suture part 32 is connected to the internal fixation part 31 and covers the retaining ring 2; the retaining ring 2 is a hollow columnar structure, and the end of the retaining ring 2 has a self-locking slope formed by bending inward; when the retaining ring 2 is engaged in the groove, the self-locking slope abuts against the slope of the groove after it fits against the internal fixation part 31.

[0026] In some embodiments, the axial width of the groove gradually decreases radially from the inside to the outside, such that the upper end face and / or lower end face of the groove are inwardly inclined first slope and / or second slope; the top end and / or bottom end of the retaining ring 2 are bent inward to form a first self-locking slope 21 and / or a second self-locking slope 22 that matches the first slope and / or the second slope; when the retaining ring 2 is engaged in the groove, the first self-locking slope 21 and / or the second self-locking slope 22 respectively fit against the inner fixing part 31 and then abut against the first slope and / or the second slope.

[0027] In some embodiments, one end of the external suture 32 is connected to one end of the internal fixation part 31, and the other end of the external suture 32 extends away from the valve annulus 1 and is connected to the other end of the internal fixation part 31, completely covering the retaining ring 2.

[0028] In some embodiments, the inner edge of the top of the retaining ring 2 is bent downwards and then bent inwards and upwards towards the groove to form a first self-locking inclined surface 21; when the retaining ring 2 is in its natural state, the angle between the first self-locking inclined surface 21 and the vertical plane is α1.

[0029] In some embodiments, when the retaining ring 2 is engaged in the groove, the angle between the first self-locking inclined surface 21 and the vertical plane is β1, where β1 > α1, so that the first self-locking inclined surface 21 applies a pre-tightening force to the first inclined surface of the groove.

[0030] In some embodiments, the inner edge of the bottom end of the retaining ring 2 is bent upward and then bent inward and downward towards the groove to form a second self-locking inclined surface 22; when the retaining ring 2 is in its natural state, the angle between the second self-locking inclined surface 22 and the vertical plane is α2.

[0031] In some embodiments, when the retaining ring 2 is engaged in the groove, the angle between the second self-locking inclined surface 22 and the vertical plane is β2, where β2 > α2, so that the second self-locking inclined surface 22 applies a preload force to the second inclined surface of the groove.

[0032] In some embodiments, the outer wall of the retaining ring 2 is provided with a plurality of V-shaped grooves 23, which are spaced apart along the axial direction and surround the outer wall of the retaining ring 2 circumferentially; when external pressure is applied to the retaining ring 2, the V-shaped grooves 23 are compressed and the height of the retaining ring 2 decreases; at the same time, the first self-locking inclined surface 21 and / or the second self-locking inclined surface 22 are flipped outward respectively, so that the inner diameter of the retaining ring 2 increases.

[0033] Specifically, the size of the retaining ring 2 in its natural state is greater than or equal to the internal accommodating size of the groove, making it difficult to install the retaining ring 2 into the groove. Installation is only possible after the retaining ring 2 is compressed and deformed. During installation, radial external pressure is applied, causing the V-groove 23 to compress, reducing the height of the retaining ring 2 from H to H'. Simultaneously, the first self-locking inclined surface 21 and / or the second self-locking inclined surface 22 are flipped outwards, increasing the inner diameter of the retaining ring 2 from R to R'.

[0034] In some embodiments, when radial external pressure is applied to the retaining ring 2, the first self-locking inclined surface 21 flips outward at an angle of ϒ1 with the vertical plane, where ϒ1 < α1.

[0035] In some embodiments, when radial external pressure is applied to the retaining ring 2, the second self-locking inclined surface 22 flips outward at an angle of ϒ2 with the vertical plane, where ϒ2 < α2.

[0036] In some embodiments, the retaining ring 2 is made of an elastic material with good biocompatibility. Cobalt-chromium alloy, titanium alloy, or nickel-titanium alloy can be selected.

[0037] In some embodiments, the suture membrane 3 is made of expanded polytetrafluoroethylene or medical polyester fabric.

[0038] Figure 7 This is a schematic diagram of force decomposition of the suture assembly for an artificial heart valve in an embodiment of the present invention when subjected to external force; Figure 8 This is a schematic diagram of a suture assembly in the prior art when subjected to external force.

[0039] See Figure 7 and Figure 8 When manually rotating the valve annulus 1 to adjust the valve leaflet opening direction in order to obtain better hemodynamics, the elastic deformation generated by the suture assembly produces a pre-tightening force on the valve annulus 1, thereby generating a positive pressure perpendicular to the contact surface between the suture assembly and the valve annulus 1. The torque required to manually rotate the valve is proportional to this positive pressure. Therefore, it is expected to obtain a sufficiently small torque for manually rotating the valve, that is, this positive pressure needs to be small enough.

[0040] In the prior art, the upper and lower ends of the groove on the outer wall of the valve annulus 1 are both planar. The suture assembly includes a suture membrane 3, a spring retainer 4, and a cover ring 5. The radial elastic deformation of the spring retainer 4 generates a preload force F on the valve annulus 1. 预紧力 The preload F 预紧力 The torque required to manually rotate the valve is proportional to the positive pressure perpendicular to the contact surface between the suture assembly and the valve annulus 1.

[0041] In this embodiment, the elastic deformation of the first self-locking inclined surface 21 and / or the second self-locking inclined surface 22 after the retaining ring 2 is assembled generates a preload force F on the valve ring 1. 预紧力This generates a positive pressure perpendicular to the contact surface (first inclined surface and / or second inclined surface) between the suture assembly and the valve annulus 1, which is the preload force F. 预紧力 The component force F2', F2' < F 预紧力 Under the same preset preload, the valve ring 1 experiences less positive pressure, and the torque required to manually rotate the valve is less.

[0042] After implantation, the valve is sutured to the body's original tissue. Due to the elasticity of the original tissue and the subsequent restoration of blood flow and circulation, the original tissue expands due to cardiac pulsation, blood impact, and blood flow. The valve is then subjected to a radially outward force F. 外力 Function: To ensure sufficient friction to prevent unintended rotation of the valve ring 1 under external force, the positive pressure perpendicular to the contact surface between the suture assembly and the valve ring 1 must be large enough to generate sufficient friction to prevent unintended rotation of the valve ring 1; and this pressure must not decrease as the external force increases.

[0043] In existing technology, the external force F 外力 With preload F 预紧力 In opposite directions, the positive pressure of the spring retainer 4 on the valve ring 1 is F. 预紧力 -F 外力 External force F 外力 Pulling the spring retainer 4 reduces the preload force of the spring retainer 4 on the valve ring 1, further reducing the positive pressure on the contact surface, which in turn reduces the frictional resistance of the contact surface. This can easily cause unnecessary rotation of the valve ring 1, and more dangerously, it may cause the valve ring 1 to detach.

[0044] In this embodiment, the external force F 外力 When the retaining ring 2 is applied, the positive pressure exerted by the retaining ring 2 on the valve ring 1 is F2' + F2, where F2 is the external force F. 外力 The component of force perpendicular to the contact surface (first inclined surface and / or second inclined surface) between the suture assembly and the valve annulus 1 increases the positive pressure on the contact surface, which in turn increases the friction on the contact surface, forming a self-locking mechanism. This makes it more difficult for the valve annulus 1 to generate unnecessary rotation. Compared with existing technologies, the overall performance of the valve is safer after implantation.

[0045] Specifically, achieving complete self-locking requires an external force F. 外力 The frictional force generated by the component force F2 perpendicular to the contact surface (first inclined surface and / or second inclined surface) between the suture assembly and valve annulus 1 is greater than or equal to the external force F. 外力 The component force F1 along the contact surface (first inclined surface and / or second inclined surface) between the suture assembly and the valve ring 1, i.e. μF2≥F1 (μ is the friction coefficient of the contact surface between the clasp 2 and the suture membrane 3), then the included angles β1 and β2 must satisfy cotβ1≤μ and cotβ2≤μ.

[0046] Specifically, when μ=0.4, β1≤21°, β2≤21°.

[0047] Specifically, the included angles β1 and β2 are determined according to the coefficient of friction of the contact surface between the retaining ring 2 and the suture membrane 3; as β1 and β2 gradually increase, the self-locking effect gradually weakens until it is lost when it increases to 90°. Preferably, both β1 and β2 are less than 45°; more preferably, both β1 and β2 are between 10° and 25°.

[0048] In summary, the artificial heart valve of the present invention adjusts the connection structure of the valve annulus 1 and the retaining ring 2, setting the upper and / or lower end surfaces of the groove on the outer wall of the valve annulus 1 as inwardly inclined first and / or second inclined surfaces; the top and / or bottom ends of the retaining ring 2 are bent inward to form a first self-locking inclined surface 21 and / or a second self-locking inclined surface 22; when the retaining ring 2 is engaged in the groove, the first self-locking inclined surface 21 and / or the second self-locking inclined surface 22 respectively fit against the inner fixing part 31 and then abut against the first and / or second inclined surfaces; the retaining ring 2 provides sufficient support for the valve annulus 1, and due to the change in the contact surface, the torque required to manually rotate the valve annulus 1 is greatly reduced; when an external force intervenes radially outward, the positive pressure of the retaining ring 2 on the suture membrane 3 and the valve annulus 1 is increased, the friction is increased, the valve annulus 1 is more securely fixed, and the uncontrollable rotation of the valve annulus 1 is prevented; For example, the outer wall of the retaining ring 2 is provided with a V-shaped groove 23 to achieve radial compression during the installation of the retaining ring 2. Through its elastic deformation, it provides sufficient preload after being installed in the groove of the valve ring 1. The retaining ring 2 simultaneously performs the dual functions of preload and self-locking: the preload is provided by the elastic deformation of the retaining ring 2, and the self-locking force is enhanced by the wedge effect of the self-locking inclined surface under the action of external force. The two functions are realized by the same component, eliminating the need for additional locking parts and simplifying the structure.

[0049] Although specific embodiments have been described above, these embodiments are not intended to limit the scope of the invention, even when only a single embodiment is described with respect to a particular feature. The feature examples provided in this disclosure are intended to be illustrative and not limiting, unless otherwise stated. In practice, one or more technical features of the dependent claims may be combined with the technical features of the independent claims as needed and where technically feasible, and may be derived from the technical features of the respective independent claims in any suitable manner rather than solely by the specific combinations listed in the claims.

[0050] While the present invention has been disclosed above, it is not limited thereto. Any person skilled in the art can make various modifications and alterations without departing from the spirit and scope of the invention; therefore, the scope of protection of the present invention should be determined by the scope defined in the claims.

Claims

1. A suture assembly for an artificial heart valve, characterized in that, The artificial heart valve has a groove along its circumferential direction on the outer wall of the valve annulus, the groove having an inwardly inclined slope; the suture assembly includes a suture membrane and a retaining ring, the suture membrane being used to connect to the original human tissue, the retaining ring being used to fix the suture membrane to the valve annulus and allow the valve annulus to rotate along the retaining ring; the suture membrane includes at least an internal fixation part and an external suture part, the internal fixation part being located between the valve annulus and the retaining ring and closely abutting the groove, the external suture part being connected to the internal fixation part and covering the retaining ring; the retaining ring has a hollow cylindrical structure, the end of the retaining ring having an inwardly bent self-locking slope; when the retaining ring is engaged in the groove, the self-locking slope adheres to the internal fixation part and then... The groove's inclined surface abuts against the surface; the axial width of the groove gradually decreases radially from the inside to the outside, making the upper and / or lower end surfaces of the groove inwardly inclined first and / or second inclined surfaces; the top and / or bottom ends of the retaining ring are bent inward to form a first self-locking inclined surface and / or a second self-locking inclined surface that matches the first and / or second inclined surfaces; the outer wall of the retaining ring is provided with multiple V-shaped grooves, which are spaced apart axially and circumferentially surround the outer wall of the retaining ring; when external pressure is applied to the retaining ring, the V-shaped grooves are compressed, and the height of the retaining ring decreases; simultaneously, the first and / or second self-locking inclined surfaces flip outward, increasing the inner diameter of the retaining ring.

2. The suture assembly for an artificial heart valve according to claim 1, characterized in that, One end of the external suture is connected to one end of the internal fixation part, and the other end of the external suture extends away from the valve annulus and is connected to the other end of the internal fixation part to completely cover the retaining ring.

3. The suture assembly for an artificial heart valve according to claim 1, characterized in that, The inner edge of the top of the retaining ring is bent downwards and then bent inwards and upwards to form a first self-locking slope; when the retaining ring is in its natural state, the angle between the first self-locking slope and the vertical plane is α1.

4. The suture assembly for an artificial heart valve according to claim 3, characterized in that, The angle between the first inclined plane and the vertical plane is β1. When the retaining ring is engaged in the groove, the angle between the first self-locking inclined plane and the vertical plane is β1. The first self-locking inclined surface applies a preload force to the first inclined surface.

5. The suture assembly for an artificial heart valve according to claim 1, characterized in that, The inner edge of the bottom end of the retaining ring is bent upward and then bent inward and downward to form a second self-locking slope; when the retaining ring is in its natural state, the angle between the second self-locking slope and the vertical plane is α2.

6. The suture assembly for an artificial heart valve according to claim 5, characterized in that, The angle between the second inclined plane and the vertical plane is β2. When the retaining ring is engaged in the groove, the angle between the second self-locking inclined plane and the vertical plane is β2. The second self-locking inclined plane applies a preload force to the second inclined plane.

7. The suture assembly for an artificial heart valve according to claim 3, characterized in that, When radial external pressure is applied to the retaining ring, the first self-locking inclined plane flips outward at an angle to the vertical plane. , .

8. The suture assembly for an artificial heart valve according to claim 5, characterized in that, When radial external pressure is applied to the retaining ring, the second self-locking inclined plane flips outward at an angle equal to that of the vertical plane. , .

9. The suture assembly for an artificial heart valve according to claim 1, characterized in that, The retaining ring is made of an elastic material with good biocompatibility.

10. An artificial heart valve, characterized in that, Includes the suture assembly for artificial heart valves as described in any one of claims 1-9.

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