Heart valve capable of reducing regurgitation

Abstract

The invention discloses a heart valve capable of reducing backflow. The heart valve comprises a valve support, a plurality of valve leaflets and a valve leaflet opening amplitude limiting unit. The valve leaflet opening amplitude limiting unit is connected with each valve leaflet and forms a closed or discontinuous annular structure in the circumferential direction; the valve leaflet opening amplitude limiting unit can support the valve leaflet at the position where the valve leaflet opening amplitude limiting unit is connected with each valve leaflet when the valve leaflet is opened through the annular structure which is connected between the valve leaflet in an attached mode so as to limit movement of a part of breadth on the valve leaflet in the opening direction. And the volume of liquid surrounded by the valve leaflet in a completely open state is reduced. The valve leaflet opening amplitude limiting units are connected between valve leaflets in an attached mode, annular structures capable of supporting the valve leaflets at all the connecting positions are formed on the valve leaflets, the size of the breadth where the valve leaflets can move when opened is limited, and therefore the volume of liquid surrounded by the valve leaflets in the completely-opened state is reduced; the backflow amount of the heart valve is reduced.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a heart valve that can reduce regurgitation. Background Technology

[0002] Heart valve prostheses function by opening and closing the leaflets. Valve regurgitation is a common problem in the application of valve prostheses, and reducing the regurgitation volume is an important indicator for evaluating valve prosthesis performance. Typically, the regurgitation volume of a valve prosthesis is the sum of the amount of closure during leaflet closure and the amount of leakage after closure. Therefore, both the amount of closure during leaflet closure and the amount of leakage after closure affect the magnitude of the regurgitation volume. Summary of the Invention

[0003] The purpose of this invention is to provide a heart valve that can reduce regurgitation, thereby solving the problem of heart valve regurgitation.

[0004] This invention is achieved through the following technical solution: Heart valves that can reduce regurgitation include valve stents, multiple leaflets, and leaflet opening amplitude limiting units; The leaflet opening amplitude limiting unit is connected to each leaflet and forms a closed or discontinuous ring structure in the circumferential direction. By attaching the ring structure between the leaflets, the leaflet opening amplitude limiting unit can support the leaflets at the position where it is connected to each leaflet when the leaflets are open, so as to limit the movement of a part of the leaflet in the opening direction and reduce the volume of liquid surrounded by the leaflets in the fully open state.

[0005] In some embodiments, the leaflet opening amplitude limiting unit is a closed ring structure formed by sequentially connecting each leaflet with a flexible line.

[0006] In some embodiments, the leaflet opening amplitude limiting unit is formed by using flexible lines that pass through multiple points on each leaflet sequentially, and then connect with each leaflet sequentially to form the aforementioned annular structure.

[0007] In some embodiments, the leaflet opening amplitude limiting unit is a discontinuous ring structure formed by connecting two adjacent leaflets with flexible lines.

[0008] In some embodiments, the leaflet opening amplitude limiting unit includes anchors respectively connected to each leaflet, the anchors being connected by flexible wires.

[0009] In some embodiments, the heart valve is provided with multiple sets of leaflet opening amplitude limiting units.

[0010] In some embodiments, a gasket is provided on one or both sides of the leaflet at the connection position between the leaflet opening amplitude limiting unit and each leaflet.

[0011] In some embodiments, the gasket is fixedly connected to the leaflet.

[0012] In some embodiments, the gasket is made of the same material as the leaflet or silicone, PU, ​​metal, or plastic.

[0013] Compared with the prior art, the present invention has the following advantages and beneficial effects: This invention employs a leaflet opening amplitude limiting unit attached to and connected to the leaflets, forming a ring-shaped structure on the leaflets that provides support at various connection points. When the leaflets open, the supporting effect of the leaflet opening amplitude limiting unit restricts a portion of the leaflet's surface from moving in the opening direction, reducing the size of the leaflet's movement and thus reducing the volume of fluid enclosed by the leaflet in its fully open state. This reduces the difference in fluid volume between the open and closed states, thereby reducing the amount of closure during leaflet closure and ultimately reducing the regurgitation of the heart valves.

[0014] This invention directly uses flexible wires to form connections between leaflets, limiting the opening range of the leaflets. The implementation method is simple and can be directly applied to finished valves. It has little impact on finished valves and does not affect the opening area of ​​the leaflets, the overall size of the valve, or other performance indicators. It does not affect the valve implantation operation and has little impact on the cost of valve implantation, and can significantly improve the overall performance of the valve. Attached Figure Description

[0015] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings in the embodiments will be briefly described below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0016] Figure 1 This is a schematic diagram illustrating the principle of leaflet closure in existing heart valve prostheses.

[0017] Figure 2 This is a schematic diagram illustrating the opening state of the leaflets in an existing heart valve prosthesis.

[0018] Figure 3 This is a schematic diagram illustrating the principle of heart valve closure in an embodiment of the present invention.

[0019] Figure 4This is a schematic diagram illustrating the principle of the heart valve opening state in an embodiment of the present invention.

[0020] Figure 5 This is a schematic diagram of the inflow side of a heart valve leaflet in a closed state, according to one embodiment of the present invention.

[0021] Figure 6 This is a schematic diagram of the outflow end of a heart valve leaflet in the open state, according to one embodiment of the present invention.

[0022] Figure 7 This is a schematic diagram of the wiring connecting the flexible wire to the leaflet in a heart valve according to one embodiment of the present invention.

[0023] Figure 8 This is a schematic diagram of a heart valve structure according to another embodiment of the present invention.

[0024] Figure 9 This is a schematic diagram of the wiring connecting the flexible wire to the leaflet in a heart valve according to another embodiment of the present invention.

[0025] Figure 10 This is a schematic diagram of the leaflet opening amplitude limiting unit in an embodiment of the present invention, which uses a flexible line to form a discontinuous ring structure.

[0026] Figure 11 This is a schematic diagram of the structure in which the leaflet opening amplitude limiting unit is connected to the leaflet using an anchor in an embodiment of the present invention.

[0027] Figure 12 This is a schematic diagram of the connection structure between the anchor and the leaflet of the leaflet opening amplitude limiting unit in an embodiment of the present invention.

[0028] Figure 13 This is a top view of the structure of two sets of leaflet opening amplitude limiting units arranged at approximately the same height position on the heart valve in an embodiment of the present invention.

[0029] Figure 14 This is a top view of the structure of two sets of leaflet opening amplitude limiting units set at different height positions of the heart valve in an embodiment of the present invention.

[0030] Figure 15 This is a cross-sectional schematic diagram of two sets of leaflet opening amplitude limiting units arranged axially on the heart valve in an embodiment of the present invention.

[0031] Figure 16 This is a schematic diagram of a structure in which a gasket is provided on the leaflet in an embodiment of the present invention.

[0032] in: 11. Valve stent; 12. Valve leaflet; 20. Leaflet opening amplitude limiting unit; 22. Flexible line; 23. Connector; 26. Anchor; 30. Gasket. Detailed Implementation

[0033] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are some embodiments of the present invention, but not all embodiments.

[0034] Based on the analysis of the movement of the leaflets during the opening and closing process, the inventors discovered that the amount of closure during the leaflet closure process is directly related to the difference in the volume of liquid enclosed by the leaflets in the open and closed states.

[0035] by Figure 1 and Figure 2 For example, in existing heart valves, the volume of fluid enclosed by the leaflets gradually decreases as the leaflets move from the open to the closed state. When the leaflets are fully open, they move under the pressure of blood flow to fit against the valve frame, at which point the volume of fluid enclosed by the leaflets is at its maximum. When the leaflets are fully closed, they come together, at which point the volume of fluid enclosed by the leaflets is at its minimum. Studies have shown that the greater the difference in the volume of fluid enclosed by the leaflets between the two states, the greater the closure during the leaflet closure process, and correspondingly, the greater the regurgitation of the valve.

[0036] Based on this discovery, the present invention, by setting a leaflet opening amplitude limiting unit, limits the opening amplitude of the leaflet by restricting the size of the area of ​​movement that the leaflet can undergo when opening, thereby reducing the amount of closure. (Refer to...) Figure 3 and Figure 4 Under the constraint of the leaflet opening amplitude limiting unit, when the leaflet is fully open, due to the restriction of movement of part of the leaflet's width, it will maintain a certain distance from the leaflet frame, compared to... Figure 2 At this point, the volume of liquid enclosed by the fully open leaflets is significantly reduced; for example... Figure 1 and Figure 3 In both different valve structures, the volume of fluid enclosed by the leaflets when fully closed is the same. Therefore, compared with existing heart valves, the difference in the volume of fluid enclosed by the leaflets in the two states of the heart valve of the present invention is smaller. Correspondingly, the amount of closure during the leaflet closure process is also smaller, thereby achieving the purpose of reducing regurgitation.

[0037] Based on the above technical approach, and referring to Figure 2 , Figure 3 , Figure 4 , Figure 5 , Figure 6and Figure 7 In some embodiments of the present invention, the heart valve capable of reducing regurgitation includes a valve stent 11, multiple leaflets 12, and a leaflet opening amplitude limiting unit 20. The leaflet opening amplitude limiting unit 20 is connected to each leaflet and forms a closed or discontinuous ring structure in the circumferential direction. By attaching the ring structure between the leaflets, the leaflet opening amplitude limiting unit can support the leaflets at the position where it is connected to each leaflet when the leaflets are open, so as to limit the movement of a part of the leaflet in the opening direction and reduce the volume of liquid surrounded by the leaflets in the fully open state.

[0038] by Figure 5 , Figure 10 For example, the leaflet width refers to the surface area of ​​the leaflet. Based on the annular structure of the leaflet opening amplitude limiting unit and the connection between the leaflet opening amplitude limiting unit and each leaflet, when the leaflet opens, the interaction force between the leaflet opening amplitude limiting unit and the leaflet enables the leaflet opening amplitude limiting unit to provide support for the leaflet at each connection position. At this time, the part of the leaflet located outside the support position (outside the annular structure) will not move towards the leaf frame under the action of the leaflet opening amplitude limiting unit, thereby limiting the size of the leaflet that can move.

[0039] The following description of the embodiments of the heart valve of the present invention and the accompanying drawings all take a heart valve with three leaflets as an example. Of course, the number of leaflets is not limited to three.

[0040] In some embodiments, the leaflet opening amplitude limiting unit 20 is a closed ring structure formed by sequentially connecting each leaflet with a flexible line 22.

[0041] Reference Figure 5 and Figure 8 The leaflet opening amplitude limiting unit 20 can be constructed by using a flexible wire 22 that passes sequentially through multiple points on each leaflet and connects to the three leaflets in sequence, forming a closed ring structure in the circumferential direction. As the flexible wire 22 passes sequentially through the leaflets at multiple points, it forms a support structure between the points while connecting to the leaflets. When the ring-shaped flexible wire is tensioned, it provides limiting support for the leaflets.

[0042] The following example illustrates the feasible method of forming a leaf opening amplitude limiting unit on the leaflet through the connection between the flexible line 22 and the leaflet at two or four points on the leaflet.

[0043] like Figure 7This is a schematic diagram of the routing method when a flexible wire connects to the leaflet at two points. A flexible wire passes from above to below the leaflet at one point on the leaflet, and then exits from below to above the leaflet at another point on the same leaflet. Here, "above the leaflet" refers to the side of the leaflet facing the inflow end of the heart valve, and "below the leaflet" refers to the side of the leaflet facing the outflow end of the heart valve. Repeat the above operation in sequence, connecting the flexible wire to the other two leaflets in turn, and then connecting the two ends of the flexible wire to form a closed ring structure in the circumferential direction, thus obtaining the leaflet opening amplitude limiting unit on the heart valve.

[0044] like Figure 9 This is a schematic diagram of the wiring method when the flexible wire is connected to the leaflet at four points; a flexible wire passes from above to below the leaflet at the first point of the leaflet, then exits from below to above the leaflet at the second point of the leaflet, then passes from above to below the leaflet at the third point of the leaflet, and finally exits from below to above the leaflet at the fourth point of the leaflet. Repeat the above operation in sequence, connecting the flexible wire to the other two leaflets in turn, and then connecting the two ends of the flexible wire to form a closed ring structure in the circumferential direction, thus obtaining the leaflet opening amplitude limiting unit on the heart valve.

[0045] The flexible wires connect to the leaflets at four points, distributing the force exerted by the flexible wires on the leaflets at each point to prevent the leaflets from being torn apart at the connection points, thus ensuring the reliability of the connection.

[0046] Of course, the flexible line can be connected to the leaflets at more points, as long as it does not deviate from the technical concept of the leaflet opening amplitude limiting unit of this invention, it is within the protection scope of this invention.

[0047] In some embodiments, each point on the leaflet 12 is located near the center of the leaflet, so as to simultaneously ensure the size of the opening when the leaflet opens and control the amplitude of the leaflet movement. While reducing the size of the leaflet movement amplitude, the impact on the size of the opening area between the leaflets is reduced, so as not to affect the normal performance of the valve.

[0048] In some embodiments, the flexible line 22 passes through the leaflet at two points, and the two points are located on the leaflet near the two sides of the leaflet. This can also limit the range of movement of the leaflet.

[0049] In some embodiments, the flexible line 22 passes through the leaflet at four points in sequence, and in the order of connection, the first and fourth points are located on the leaflet near the two sides of the leaflet, and the second and third points are located on the leaflet near the middle.

[0050] In some embodiments, the leaflet opening amplitude limiting unit 20 is a discontinuous ring structure formed by connecting two adjacent leaflets with flexible lines.

[0051] Reference Figure 10 The leaflet opening amplitude limiting unit 20 uses three flexible lines 22 to connect adjacent leaflets respectively, and the two ends of each flexible line 22 are connected to two adjacent leaflets respectively. At this time, the three independent flexible lines form a discontinuous ring structure in the circumferential direction. Through the connection between the flexible lines and the leaflets, three connectors 23 attached to the leaflets are formed on the leaflets, and the connectors 23 form a connection between adjacent leaflets respectively.

[0052] By connecting two adjacent leaflets with three flexible lines in sequence, when the three flexible lines are tensioned, the interaction force between the flexible lines and the leaflets can also restrict the movement of a part of the leaflet's width when the leaflets open.

[0053] The points where each flexible line 22 connects to the leaflet can be located on the leaflet near the middle of the leaflet, or on the leaflet near the two sides of the leaflet.

[0054] In some embodiments, the leaflet opening amplitude limiting unit 20 includes anchors 26 respectively connected to the three leaflets and flexible lines 22 connected to the anchors, the flexible lines 22 forming a closed or discontinuous loop in the circumferential direction.

[0055] like Figure 11 , Figure 12 Anchor 26 can be set below the leaflet, so that the connecting end of anchor 26 passes through the leaflet and extends above the leaflet. Flexible line 22 is connected to the connecting ends of the three anchors respectively. The three anchors are connected into a ring structure by the flexible line. This structure can also provide support for the leaflet at the location of the anchor, thereby limiting the opening range of the leaflet.

[0056] In this embodiment, the flexible line 22 can be a single line that passes through the through hole on the connecting end or is wrapped around the connecting end and connected to the anchor; the flexible line 22 can also be three lines, with one line connecting each pair of anchors to form an anchoring connection between adjacent leaflets.

[0057] In the above embodiments, the flexible thread 22 can be made of surgical sutures or metal wires or similar flexible metal or non-metal materials.

[0058] In the above embodiments, based on the function of the leaflet opening amplitude limiting unit and the principle of limiting the movement of the leaflet width, taking the connection between the flexible line and the leaflet as an example, an anchor point is formed at the connection point between the flexible line and the leaflet to limit the movement of the leaflet. At this time, the leaflet width located outside the anchor point will be restricted from moving under the action of the leaflet opening amplitude limiting unit. Therefore, by setting the position of the anchor point in the radial direction of the leaflet, the size of the width to be limited can be controlled. Specifically, the connection point between the flexible line and the leaflet, and the connection position between the anchor and the leaflet, can be reasonably set according to the size of the leaflet width to be limited. Figure 5 For example, this can be achieved by setting the position of each connection point in the radial direction of the leaflet.

[0059] In some embodiments, the heart valve is provided with multiple sets of leaflet opening amplitude limiting units 20.

[0060] Reference Figure 13 Multiple sets of leaflet opening amplitude limiting units 20 can be respectively arranged at approximately the same height position of the heart valve. In this embodiment, multiple sets of leaflet opening amplitude limiting units 20 are formed at approximately the same height position to better limit the movement of the leaflet width.

[0061] Each set of leaflet opening amplitude limiting units is connected to the leaflet at different points. Taking the setting of two sets of leaflet opening amplitude limiting units as an example, refer to... Figure 13 One set of leaflet opening amplitude limiting units is connected to each leaflet at the middle position of the leaflet, and the other set of leaflet opening amplitude limiting units is connected to each leaflet at two sides of the leaflet; or, one set of leaflet opening amplitude limiting units is a continuous ring structure formed by a single flexible wire, and the other set of leaflet opening amplitude limiting units is a discontinuous ring structure formed by three flexible wires; the two sets of leaflet opening amplitude limiting units are set at approximately the same height of the heart valve.

[0062] Reference Figure 14 and Figure 15 The multiple leaflet opening amplitude limiting units 20 can also be arranged in a spaced-out layer along the heart valve axis, that is, the leaflet opening amplitude limiting units are set at different height positions, which can also play the role of limiting the movement of the leaflet width.

[0063] In some embodiments, refer to Figure 16At each location, a gasket 30 is provided on one or both sides of the leaflet 12. For example, a gasket is provided on the side of the leaflet facing the outflow end, and the flexible line passes through the leaflet and the gasket in sequence, and then exits from the gasket and the leaflet in sequence; when the flexible line is tensioned, the gasket plays the role of bearing the tension force of the flexible line, so as to increase the structural strength of the leaflet at the connection position with the flexible line.

[0064] Reference Figure 16 The gasket 30 is placed on the leaflet and fixedly connected to the leaflet. The gasket can be fixedly connected to the leaflet by sewing.

[0065] The gasket 30 can be made of the same material as the leaflet, such as pericardial material, or it can be made of materials such as silicone, textiles, PU, ​​or beveled metal or plastic sheets; the shape of the gasket can be set as needed.

[0066] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., used to indicate the orientation or positional relationship are based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship that the product of this invention is usually placed in during use. They are only for the convenience of describing this invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0067] Furthermore, the use of terms such as "horizontal" and "vertical" in the description of this invention does not imply that the components are required to be absolutely horizontal or suspended, but rather that they can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted. When the terms "distal" and "proximal" do not specify a reference point, the practitioner is usually used as the reference. That is, the end closer to the practitioner or farther from the patient can be considered the "proximal," while the end farther from the practitioner or closer to the patient can be considered the "distal."

[0068] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0069] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Any simple modifications or equivalent changes made to the above embodiments based on the technical essence of the present invention shall fall within the protection scope of the present invention.

Claims

1. A heart valve capable of reducing regurgitation, characterized in that, Includes valve stents, multiple leaflets, and leaflet opening amplitude limiting unit; The leaflet opening amplitude limiting unit is connected to each leaflet and forms a closed or discontinuous ring structure in the circumferential direction. By attaching the ring structure between the leaflets, the leaflet opening amplitude limiting unit can support the leaflets at the position where it is connected to each leaflet when the leaflets are open, so as to limit the movement of a part of the leaflet in the opening direction and reduce the volume of liquid surrounded by the leaflets in the fully open state.

2. The heart valve capable of reducing regurgitation according to claim 1, characterized in that, The leaflet opening amplitude limiting unit is a closed ring structure formed by connecting each leaflet sequentially with a flexible line.

3. The heart valve capable of reducing regurgitation according to claim 2, characterized in that, The leaflet opening amplitude limiting unit is formed by using flexible lines that pass through multiple points on each leaflet sequentially, and then connect with each leaflet sequentially to form the aforementioned ring structure.

4. The heart valve capable of reducing regurgitation according to claim 1, characterized in that, The leaflet opening amplitude limiting unit is a discontinuous ring structure formed by connecting two adjacent leaflets with flexible lines.

5. The heart valve capable of reducing regurgitation according to claim 1, characterized in that, The leaflet opening amplitude limiting unit includes anchors connected to each leaflet, and the anchors are connected by flexible lines.

6. The cardiac valve capable of reducing regurgitation according to any one of claims 1-5, characterized in that, The heart valve is provided with multiple sets of leaflet opening amplitude limiting units.

7. The cardiac valve capable of reducing regurgitation according to any one of claims 2-5, characterized in that, At the connection point between the leaflet opening amplitude limiting unit and each leaflet, a gasket is provided on one or both sides of the leaflet.

8. The heart valve capable of reducing regurgitation according to claim 7, characterized in that, The gasket is fixedly connected to the leaflet.

9. The heart valve capable of reducing regurgitation according to claim 7, characterized in that, The gasket is made of the same material as the leaflet, or silicone, textile, PU, ​​metal, or plastic.

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