Replacement heart valve

• US 20020138137A1
• Filed: 05/21/2002
• Published: 09/26/2002
• Est. Priority Date: 11/01/1993
• Status: Active Grant

• Current Assignee: James L. Cox
• Original Assignee: James L. Cox
• Inventors: Cox, James L.
• Granted Patent: US 6,719,789 B2
• Time in Patent Office: Days
• US Class Current: 623/2.13
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• 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: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3629 Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3645 Connective tissue
• CPC Class Codes: A61L 27/3843 Connective tissue
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: G06Q 40/04 Trading; Exchange, e.g. stocks, commodities, derivatives or currency exchange
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A prosthetic heart valve has leaflets made of a thin and flexible material. The side edges of adjacent leaflets are sewn together so as to form a substantially tubular valve structure having an in-flow end and an out-flow end. Each of the leaflets is adapted to flex inwardly into and out of engagement with another leaflet so as to close and open the valve in response to force by blood pressure. The leaflets are configured so that a portion of the inner face of each leaflet is in a facing relationship with a portion of the inner face of an adjacent leaflet.

Claims

1. A prosthetic heart valve, comprising:

at least two cusps comprised of a thin and flexible material, each cusp having an inner surface and an outer surface and being attached to another cusp along a longitudinal suture line, each of the cusps adapted to flex inwardly into and out of engagement with another cusp so as to close and open the valve in response to force by blood pressure;

wherein a portion of the inner surface of one cusp is in a facing relationship with a portion of the inner surface of another cusp adjacent the longitudinal suture line when the valve is open.

2. The heart valve of claim 1, wherein the valve has an inlet end and an outlet end, and a portion of the inner surface of each cusp is in a facing relationship with a portion of the inner surface of each adjacent cusp adjacent the longitudinal suture line and at the outlet end of the valve.

3. The heart valve of claim 1, wherein the thin and flexible material comprises pericardial tissue.

4. The heart valve of claim 1, wherein at least one suture holds a portion of the inner surfaces of adjacent cusps together.

5. The heart valve of claim 4, wherein the inner surfaces of adjacent cusps are held together toward the out-flow end of the valve so that the cusps are biased partially closed even when the valve is generally open.

6. The heart valve of claim 4 additionally comprising suture reinforcements.

7. A method for making a prosthetic heart valve, comprising:

providing a section of substantially flat, flexible material;

cutting at least two leaflets out of the flat material, each of the leaflets having an inner face, an outer face, an in-flow end, an out-flow end, and side edges;

sewing the side edges of adjacent leaflets together so as to form a substantially tubular valve structure having an in-flow end and an out-flow end; and

configuring each leaflet so that a portion of the inner face of each leaflet is in a facing relationship with a portion of the inner face of an adjacent leaflet.

8. The method of claim 7, wherein a portion of the inner face of each leaflet is in a facing relationship with a portion of the inner face of another leaflet at the out-flow end of the valve so that the adjacent leaflets are partially closed.

9. The method of claim 7 additionally comprising installing a suture stitch through each leaflet to hold a portion of the inner face of the leaflet in a facing relationship with a portion of the inner face of an adjacent leaflet.

10. The method of claim 9 additionally comprising providing reinforcements for the suture stitches.

11. The method of claim 7, comprising pinching adjacent leaflets together so that a portion of the inner faces of the adjacent leaflets are in facing relationship with each other.

12. The method of claim 11, wherein the adjacent leaflets are pinched together at the out-flow end so as to create partial closure of the adjacent leaflets.