Heart valve

• US 9,259,313 B2
• Filed: 08/14/2013
• Issued: 02/16/2016
• 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.
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US13/966,769
• Publication Number:
  US 20140005773A1
• Time in Patent Office: 916 Days
• Field of Search: 623/2.14, 623/2.16, 623/2.17, 623/2.18, 623/1.24, 623/1.26
• US Class Current: 1/1
• 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 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 when the leaflet is 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, and

wherein 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 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.

5. 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.

6. 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.

7. An artificial heart valve according to claim 1, comprising one or more further flexible leaflets, wherein each of the one or more further leaflets is movable relative to the support structure between an open configuration in which the leaflet and the one or more further leaflets permit blood flow through the aperture and a closed configuration in which the leaflet and the one or more further leaflets restrict blood flow through the aperture,

wherein a lateral cross-section taken through any one of the one or more further leaflets 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 when said further leaflet is 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 further leaflet is formed, and

wherein each of the one or more further leaflets is attached to the support structure along respective at least partially straight first and second lines of attachment such that movement of any one of the one or more further leaflets between a corresponding open and closed configuration results in the convex portion of the lateral cross-section of the further leaflet pivoting about one of the corresponding first and second lines of attachment and the concave portion of the lateral cross-section of the further leaflet pivoting about the other of the corresponding first and second lines of attachment.

8. An artificial heart valve according to claim 1, wherein a curvature of the convex portion of the lateral cross-section of the leaflet is substantially matched to a curvature of a concave portion of a lateral cross-section of one of the one or more further leaflets adjacent to the leaflet, wherein said lateral cross-sections are taken through the leaflet and the adjacent further leaflet in the same plane lateral to the axis.

9. 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 surround a portion of the support structure.

10. An artificial heart valve according to claim 9, wherein the through hole is elongated.

11. An artificial heart valve according to claim 9, wherein the through hole comprises a slit.

12. An artificial heart valve according to claim 9, wherein the through hole is angled with respect to a radial direction defined relative to an axis defined by the aperture.

13. An artificial heart valve according to claim 9, wherein through hole is defined in a post portion of the support structure.

14. An artificial heart, valve according to claim 9, wherein through hole is defined in a base portion of the support structure.

15. An artificial heart valve according to claim 9, 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.

16. An artificial heart valve according to claim 15, wherein the leaflet is integrally formed so as to surround a portion of the support structure adjacent to each through hole.

17. An artificial heart valve according to claim 1, wherein the leaflet is attached to the support structure along a base line of attachment which is adjacent to the aperture.

18. An artificial heart valve according to claim 17, wherein the leaflet comprises a free edge which extends opposite the base line of attachment and which 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.

19. An artificial heart valve according to claim 18, wherein the free edge of the leaflet is longer than the base line of attachment.

20. An artificial heart valve according to claim 18, 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.

21. An artificial heart valve according to claim 18, 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-optation region defining a plurality of generally identical lateral cross-sections.

22. An artificial heart valve according to claim 21, wherein the lateral cross-section is located axially between the base line of attachment and the boundary of the co-aptation region, wherein the leaflet defines a further lateral cross-section which is taken through the leaflet in a further plane which is lateral to the axis and which is located axially between the base line of attachment and the boundary of the co-aptation region at an axial position which is further from the base line of attachment than the axial position of the lateral cross-section, wherein the further lateral cross-section defines a further outwardly convex portion, a further outwardly concave portion and a further junction between the further convex portion and the further concave portion, and herein the convex portion of the lateral cross-section is longer than the further convex portion of the further lateral cross-section and the concave portion of the lateral cross-section is shorter than the further concave portion of the further lateral cross-section.

23. An artificial heart valve according to claim 17, wherein the base line of attachment is outwardly convex.

24. An artificial heart valve according to claim 17, wherein the entire base line of attachment extends circumferentially at least part way around the aperture.

25. An artificial heart valve according to claim 1, wherein a length of the convex portion of the lateral cross-section comprises a greater proportion of a total length of the lateral cross-section in the open configuration than in the closed configuration.

26. 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 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,

wherein 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, and

wherein the leaflet is attached to the support structure along a base line of attachment which is adjacent to the aperture and which is outwardly convex.

27. 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 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,

wherein 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, and

wherein the leaflet is attached to the support structure along a base line of attachment which is adjacent to the aperture and which extends circumferentially at least part way around the aperture.

28. 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 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,

wherein 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, and

wherein a length of the convex portion of the lateral cross-section comprises a greater proportion of a total length of the lateral cross-section in the open configuration than in the closed configuration.

29. 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 leaflet is attached to the support structure along first and second at least partially straight lines of attachment,

wherein the leaflet is attached to the support structure along a base line of attachment which is adjacent to the aperture,

wherein the leaflet comprises a free edge which extends opposite the base line of attachment and which extends between the first and second lines of attachment, the free edge being movable relative to the support structure,

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,

wherein the aperture defines an axis, a first lateral cross-section taken through the leaflet in a first plane lateral to the axis defines a single outwardly convex portion and a single outwardly concave portion, and a second lateral cross-section taken through the leaflet in a second plane lateral to the axis defines a single outwardly convex portion and a single outwardly concave portion,

wherein the first and second lateral cross-sections are both located axially between the base line of attachment and the boundary of the co-aptation region such that the first lateral cross-section is closer to the base line of attachment that the second lateral cross-section,

wherein the convex portion of the first lateral cross-section is longer than the convex portion of the second lateral cross-section and the concave portion of the first lateral cross-section is shorter than the concave portion of the second lateral cross-section, and

wherein the leaflet is attached to the support structure along the first and second lines of attachment such that movement of the leaflet between the open and closed configurations results in the convex portions of the first and second lateral cross-sections pivoting about one of the first and second lines of attachment and the concave portions of the first and second later cross-sections pivoting about the other of the first and second lines of attachment.

30. An artificial heart valve comprising:

a support structure comprising a generally annular base portion which defines an aperture for blood flow and which further defines a through hole extending through a wall thickness of the base portion; and

a leaflet material integrally formed around the support structure so as to define 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 in a blood flow direction and a closed configuration which the leaflet restricts blood flow through the aperture in a direction opposite to the blood flow direction,

wherein, when viewed on a longitudinal cross-section which is generally parallel to an axis defined by the aperture and which passes through the through hole, the leaflet material completely envelops the base portion, the leaflet material extends throng the through hole, and the flexible leaflet extends from the through hole.

31. An artificial heart valve according to claim 30, wherein, when viewed on the longitudinal cross-section, a curvature of a base region of the flexible leaflet adjacent to the through hole is continuous with a curvature of the portion of the leaflet material extending through the through hole.

32. An artificial heart valve according to claim 30, wherein the through hole is elongated or comprises a slit.

33. An artificial heart valve according to claim 30, wherein, when viewed on the longitudinal cross-section, the through hole extends in a direction which is angled between a radially inward direction and the direction of blood flow.

34. An artificial heart valve according to claim 30, wherein the base portion defines a plurality of through holes, each through hole extends through the wall thickness of the base portion, the leaflet material extends through two or more of the through holes, and the flexible leaflet extends from two or more of the through holes.

35. An artificial heart valve according to claim 30, wherein the support structure comprises at least one post portion extending from the base portion, the at least one post portion defining a through hole extending therethrough, and wherein, when viewed on a lateral cross-section which is generally lateral to the axis and which passes through the through hole defined by the at least one post portion of the support structure, the leaflet material completely envelops the at least one post portion, the leaflet material extends through the through hole defined by the at least one post portion, and the flexible leaflet extends from the through hole defined by the at least one post portion.

36. An artificial heart valve according to claim 30, wherein the leaflet material comprises at least one of a synthetic material, a polymer material, and polyurethane.

37. An artificial heart valve comprising:

a support structure comprising a generally annular base portion which defines an aperture for blood flow and at least one post portion extending from the base portion, the least one post portion defining a through hole which extends therethrough; and

a leaflet material integrally formed around the support structure so as to define a flexible leaflet which is movable relative to the support stricture between an open configuration in which the leaflet permits blood flow through the aperture in a blood flow direction and a closed configuration in which the leaflet restricts blood flow through the aperture in a direction opposite to the blood flow direction,

wherein, when viewed on a lateral cross-section which is generally lateral to an axis defined by the aperture and which passes through the through hole, the leaflet material completely envelops the at least one post portion, the leaflet material extends through the through hole, and the flexible leaflet extends from the through hole.

38. An artificial heart valve according to claim 37, wherein, when viewed on the lateral cross-section, curvature of a side region of the flexible leaflet adjacent to the through hole is continuous with curvature of the portion of the leaflet polymer material extending through the through hole.

39. An artificial heart valve according to claim 37, wherein the through hole is elongated or comprises a slit.

40. An artificial heart valve according to claim 37, wherein, when viewed on the lateral cross-section, the through hole extends in a direction which is angled with respect to a radially inward direction.

41. An artificial heart valve according to claim 37, wherein the at least one post portion defines a plurality of through holes extending therethrough, the leaflet material extends through two or more of the through holes, and the flexible leaflet extends from two or more of the through holes.

42. An artificial heart valve according to claim 37, wherein the base portion of the support structure defines a through hole extending through a wall thickness of the base portion and, when viewed on a longitudinal cross-section which is generally parallel to the axis and which passes through the through hole defined by the base portion, the leaflet material completely envelops the base portion, the leaflet material extends through the through hole defined by the base portion, and the flexible leaflet extends from the through hole defined by the base portion.

43. An artificial heart valve according to claim 37, wherein the leaflet material comprises at least one of a synthetic material, a polymer material, and polyurethane.

44. An artificial heart valve, comprising:

a support structure comprising a generally annular base portion which defines an aperture for blood flow and which further defines a through hole extending through a wall thickness of the base portion; and

a leaflet material integrally formed around the support structure so as to define 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 in a direction of blood flow and a closed configuration in which the leaflet restricts blood flow through the aperture in a direction opposite to the direction of blood flow,

wherein, when viewed on a longitudinal cross-section which is generally parallel to an axis defined by the aperture and which passes through the through hole, the through hole extends in a direction which is angled between a radially inward direction and the direction of blood flow, the leaflet material completely envelops the base portion, and the leaflet material extends through the through hole.

45. An artificial heart valve, comprising:

a support structure comprising a generally annular base portion which defines an aperture for blood flow and which further defines a through hole extending through a wall thickness of the base portion; and

a leaflet material integrally formed around the support structure so as to define 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 in a direction of blood flow and a closed configuration in which the leaflet restricts blood flow through the aperture in a direction opposite to the direction of blood flow,

wherein, when viewed on a longitudinal cross-section which is generally parallel to an axis defined by the aperture and which passes through the through hole, the leaflet material completely envelops the base portion, the leaflet material extends through the through hole, and a curvature of a base region of the flexible leaflet adjacent to the through hole is continuous with a curvature of the portion of the leaflet material extending through the through hole.

46. An artificial heart valve, comprising:

a support structure comprising a generally annular base portion which defines an aperture for blood flow and at least one post portion extending from the base portion, the at least one post portion defining a through hole which extends therethrough; and

a leaflet material integrally formed around the support structure so as to define 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 in a direction of blood and a closed configuration in which the leaflet restricts blood flow through the aperture in a direction opposite to the direction of blood flow,

wherein, when viewed on a lateral cross-section which is generally lateral to an axis defined by the aperture and which passes through the through hole, the through hole extends in a direction which is angled relative to a radially inward direction, the leaflet material completely envelops the at least one post portion, and the leaflet material extends through the through hole.

47. An artificial heart valve comprising,

a support structure comprising a generally annular base portion which defines an aperture for blood flow and at least one post portion extending from the base portion, the at least one post portion defining a through hole which extends therethrough;

and

a leaflet material integrally formed around the support structure so as to define 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 in a direction of blood flow and a closed configuration in which the leaflet restricts blood flow through the aperture in a direction opposite to the direction of blood flow,

wherein, when viewed on a lateral cross-section which is generally lateral to an axis defined by the aperture and which passes through the through hole, the leaflet material completely envelops the at least one post portion, the leaflet material extends through the through hole, and a curvature of a side region of the flexible leaflet adjacent to the through hole is continuous with a curvature of the portion of the leaflet material extending through the through hole.