Heart Valve

• US 20140005773A1
• Filed: 08/14/2013
• Published: 01/02/2014
• Est. Priority Date: 02/18/2011
• Status: Active Grant

• Current Assignee: The David J. Wheatley Discretionary Trusts
• Original Assignee: David J. Wheatley
• Inventors: Wheatley, David J.
• Granted Patent: US 9,259,313 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/006 modular

Abstract

An artificial heart valve comprises a support structure defining an aperture for blood flow and a flexible leaflet connected to the support structure along first and second at least partially straight lines of attachment, wherein the leaflet is movable relative to the support structure between an open configuration in which the leaflet permits blood flow through the aperture and a closed configuration in which the leaflet restricts blood flow through the aperture. A lateral cross-section taken through the leaflet defines an outwardly convex portion, an outwardly concave portion and a junction between the convex and concave portions. The heart valve may be configured for implantation in a human or animal subject. A method of manufacturing a heart valve and a former for use in such a method are also disclosed.

Claims

1. An artificial heart valve comprising a support structure defining an aperture for blood flow and a flexible leaflet which is movable relative to the support structure between an open configuration in which the leaflet permits blood flow through the aperture and a closed configuration in which the leaflet restricts blood flow through the aperture, wherein the aperture defines an axis, and wherein a lateral cross-section taken through the leaflet in a plane lateral to the axis defines an outwardly convex portion, an outwardly concave portion and a junction between the convex and concave portions and the leaflet is attached to the support structure along first and second at least partially straight lines of attachment such that movement of the leaflet between the open and closed configurations results in the convex portion of the lateral cross-section pivoting about one of the first and second lines of attachment and the concave portion of the lateral cross-section pivoting about the other of the first and second lines of attachment.

2. An artificial heart valve according to claim 1, wherein the first and second lines of attachment extend in a direction which is generally parallel to the axis.

3. An artificial heart valve according to claim 1, wherein the convex portion extends from one of the first and second lines of attachment to the junction and the concave portion extends from the other of the first and second lines of attachment to the junction.

4. An artificial heart valve according to claim 1, wherein the lateral cross-section defines the outwardly convex portion, the outwardly concave portion and the junction between the convex and concave portions in the open and closed configurations and all leaflet configurations intermediate the open and closed configurations including a natural or default configuration in which the leaflet is formed.

5. An artificial heart valve according to claim 1, wherein movement of the leaflet from the closed configuration to the open configuration results in an initial increase in curvature of the convex and concave portions of the lateral cross-section of the leaflet followed by a decrease in curvature of the convex portion and a further increase in curvature of the concave portion.

6. An artificial heart valve according to claim 1, wherein the heart valve is configured such that movement of the leaflet results in movement of the junction along the lateral cross-section of the leaflet.

7. An artificial heart valve according to claim 1, wherein movement of the leaflet from the closed configuration to the open configuration results initially in no movement of the junction along the lateral cross-section of the leaflet followed by movement of the junction along the lateral cross-section of the leaflet from the first or second line of attachment about which the convex portion pivots towards the other of the first and second lines of attachment.

8. An artificial heart valve according to claim 1, wherein the leaflet is connected to the support structure along a base line of attachment which is adjacent to the aperture and the leaflet comprises a free edge which extends opposite the base line of attachment and extends between the first and second lines of attachment, the free edge being movable relative to the support structure, and the free edge defining an outwardly convex portion, an outwardly concave portion and a junction between the convex and concave portions.

9. An artificial heart valve according to claim 8, wherein the free edge of the leaflet is longer than the base line of attachment.

10. An artificial heart valve according to claim 8, wherein each of a plurality of lateral cross-sections taken through the leaflet between the base line of attachment and the free edge defines an outwardly convex portion, an outwardly concave portion and a junction between the convex and concave portions.

11. An artificial heart valve according to claim 8, wherein the leaflet defines a co-aptation region which extends from the free edge to a boundary which is located between the free edge and the base line of attachment, the co-aptation region defining a plurality of generally identical lateral cross-sections.

12. An artificial heart valve according to claim 11, wherein a lateral cross-section which is closer to the base line of attachment but between the base line of attachment and the boundary of the co-aptation region has a longer convex portion and a shorter concave portion relative to a lateral cross-section which is further from the base line of attachment but between the base line of attachment and the boundary of the co-aptation region.

13. An artificial heart valve according to claim 1, comprising a plurality of flexible leaflets, each leaflet being movable relative to the support structure between an open configuration in which the leaflets permit blood flow through the aperture and a closed configuration in which the leaflets restrict blood flow through the aperture, and wherein a lateral cross-section taken through each leaflet in a plane lateral to the axis defines a corresponding outwardly convex portion, a corresponding outwardly concave portion and a corresponding junction between the convex and concave portions and each leaflet is attached to the support structure along respective at least partially straight first and second lines of attachment such that movement of each leaflet between a corresponding open and closed configuration results in the convex portion of the lateral cross-section pivoting about one of the corresponding first and second lines of attachment and the concave portion of the lateral cross-section pivoting about the other of the corresponding first and second lines of attachment.

14. An artificial heart valve according to claim 13, wherein a curvature of a convex portion of a first leaflet is substantially matched to a curvature of a concave portion of a second leaflet adjacent to the first leaflet in a lateral cross-section taken through the first and second leaflets.

15. An artificial heart valve according to claim 1, wherein the support structure comprises a through hole and the leaflet is integrally formed so as to extend through the through hole and around a portion of the support structure.

16. An artificial heart according to claim 15, wherein the through hole is elongated.

17. An artificial heart according to claim 15, wherein the through hole comprises a slit.

18. An artificial heart according to claim 15, wherein the through hole is angled with respect to a radial direction defined relative to an axis defined by the aperture.

19. An artificial heart according to claim 15, wherein through hole is defined in a post portion of the support structure.

20. An artificial heart according to claim 15, wherein through hole is defined in a base portion of the support structure.

21. An artificial heart according to claim 15, wherein the support structure defines a plurality of through holes extending therethrough and the leaflet is integrally formed so as to extend through each of the through holes.

22. An artificial heart according to claim 21, wherein the leaflet is integrally formed so as to extend around a portion of the support structure adjacent to each through hole.

23. An artificial heart valve comprising a support structure defining an aperture for blood flow and a flexible leaflet connected to the support structure along first and second lines of attachment, wherein the leaflet is movable relative to the support structure between an open configuration in which the leaflet permits blood flow through the aperture and a closed configuration in which the leaflet restricts blood flow through the aperture, and wherein the aperture defines an axis and a lateral cross-section taken through the leaflet in a plane lateral to the axis defines an outwardly convex portion extending from one of the first and second lines of attachment to a junction and an outwardly concave portion extending from the other of the first and second lines of attachment to the junction.

24. An artificial heart valve comprising a support structure and at least one flexible leaflet, wherein the support structure defines an aperture for blood flow and a through hole and each leaflet is integrally formed so as to extend through the through hole and around a portion of the support structure.

25. An artificial heart according to claim 24, wherein the through hole is elongated.

26. An artificial heart according to claim 24, wherein the through hole comprises a slit.

27. An artificial heart according to claim 24, wherein the through hole is angled with respect to a radial direction defined relative to an axis defined by the aperture.

28. An artificial heart according to claim 24, wherein through hole is defined in a post portion of the support structure.

29. An artificial heart according to claim 24, wherein through hole is defined in a base portion of the support structure.

30. An artificial heart according to claim 24, wherein the support structure defines a plurality of through holes and the leaflet is integrally formed so as to extend through each of the through holes and around a portion of the support structure adjacent to each through hole.