Fiber-reinforced heart valve prosthesis

• US 6,726,715 B2
• Filed: 10/23/2001
• Issued: 04/27/2004
• Est. Priority Date: 10/23/2001
• Status: Expired due to Fees

• Current Assignee: Children's Medical Center Corporation
• Original Assignee: Children's Medical Center Corporation
• Inventors: Sutherland, Fraser W. H.
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Chattopadhyay, Urmi
• Application Number:
  US10/004,317
• Publication Number:
  US 20030078652A1
• Time in Patent Office: 917 Days
• Field of Search: 623/2.1, 623/2-2-, 623/242, 623/900, 623/11.11, 623/66.1, 606/151, 600/37
• US Class Current: 623/2.1
• 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 2/2418 Scaffolds therefor, e.g. support stents

Abstract

A heart valve prosthesis for use as an aortic or pulmonary replacement valve, or as a mitral or tricuspid valve includes leaflets that are reinforced through the use of oriented fiber components in a laminated composite, in which the leaflets of the valve are reinforced with fiber-reinforcing materials oriented along lines of stress in the material, thus to provide a long-lived valve that provides strength at points of maximal stress that have hitherto been foci for material failure. In a preferred embodiment involving a stentless valve, the reinforcing materials are optimized in terms of the density and orientation of the fibers in the composite materials, thus to extend the life of a stentless valve, with the valve requiring no anti-coagulants as is the case with mechanical valves and exhibiting no hemolysis in which red cells are damaged by the action of mechanical valves. Longevity exceeds thirty five years in most cases, making replacement of such a valve a remote possibility. In one embodiment, oriented fiber components of various geometries are provided by laying fibers in specific orientation over a curved mold to which polymer sheets are laminated.

Claims

1. A leaflet for a heart valve having an improved lifetime, comprising:

a sheet of flexible material configured in the form of said leaflet; and

,

a number of stress-relieving highly flexible fine fibrous elements affixed to said sheet and having lengths which are aligned with predetermined stress lines corresponding to lines of stress in said leaflet when said leaflet is deployed in said valve and said valve is operated so as to flex said leaflet.

2. The leaflet of claim 1, wherein the stress relieving elements run from one edge of said leaflet to another.

3. The leaflet of claim 2, and further including a cuff having opposing commisures, wherein opposed portions of said leaf are attached to opposed commisures, and wherein said stress relieving elements run from the portion of one leaflet attached to one commisure to the portion of said leaflet attached to said opposing commisure.

4. The leaflet of claim 3, wherein the density and direction of the stress lines in said leaflet at the point of attachment to a commisure differs in direction and density at other areas of said leaflet such that the direction and density of said stress relieving elements is tailored to the stresses to be experienced by said leaflet in the operation of said valve.

5. In a heart valve, a heart valve leaflet having stress relieving highly flexible fine fibrous elements tailored in density and direction to expected stresses within said leaflet when said heart valve is in operation.

6. The heart valve leaflet of claim 5, wherein said heart valve is an aortic valve.

7. The heart valve leaflet of claim 5, wherein said heart valve is a pulmonary valve.

8. The heart valve leaflet of claim 5, wherein said heart valve is a mitral valve.

9. The heart valve leaflet of claim 5, wherein said heart valve is a tricuspid valve.

10. The heart valve of claim 5, wherein said stress relieving fibrous elements are selected from the group consisting of fibers, strands and filaments.

11. The heart valve of claim 10, wherein said leaflet includes a flexible sheet and wherein said stress relieving fibrous elements are affixed to said sheet in predetermined directions and densities corresponding to the direction and density of local stress lines within said leaflet corresponding to said expected stresses.