Heart valve prosthesis and method for the production thereof

• US 4,218,782 A
• Filed: 05/19/1978
• Issued: 08/26/1980
• Est. Priority Date: 05/25/1977
• Status: Expired due to Term

• Current Assignee: Biocoating Anpartsselskab
• Original Assignee: Biocoating Anpartsselskab
• Inventors: Rygg, Inge H.
• Primary Examiner(s): Frinks, Ronald L.
• Application Number:
  US05/907,580
• Time in Patent Office: 830 Days
• Field of Search: 3/1.5, 3/1.4, 3/1
• US Class Current: 623/2.15
• CPC Class Codes: A61F 2/2415 Manufacturing methods

Abstract

A flexible non-stented heart valve prosthesis made from a flat piece of a stabilized biological membrane. The membrane is folded along one or more folding lines and attached to a flat flexible non-biological base material so that one or more leaflets are formed. Preferably the membrane is pericardium and is attached by machine stitching to a woven polymeric base material. Different valve types including ventricular outflow patches and three-leaflet valves such as aortic valves and methods for their production are described.

The aortic valve is preferably made from three separate leaflets provided with narrow base materials serving as attachment margins which are stitched together in a manner to form a three-leaflet valve.

Claims

1. A heart valve prosthesis made from a flat strip piece of a stabilized biological membrane which is folded along at least one folding line to form opposed layers and attached to a flat flexible non-biological base material to form at least one leaflet.

2. The heart valve prosthesis according to claim 1, wherein the strip is attached by stitching.

3. A heart valve prosthesis according to claim 2, wherein the strip is attached by machine stitching.

4. The heart valve prosthesis according to claim 1, wherein a biological membrane having on one side a mesothelial layer, is attached so that the non-mesothelial side faces the base material.

5. The heart valve prosthesis according to claim 1, wherein the non-biological base material is a flexible polymeric material.

6. The heart valve prosthesis according to claim 5, wherein the polymeric material is a woven material.

7. The heart valve prosthesis according to claim 1, wherein the biological membrane is porcine pericardium.

8. The heart valve prosthesis according to claim 1, wherein the biological membrane is provided with a reinforcement at least in the region forming the leaflet or leaflets.

9. The heart valve prosthesis according to claim 8, wherein said reinforcement is provided by impregnating the biological membrane with a physiologically compatible polymeric material.

10. The heart valve prosthesis according to claim 4, wherein the biological membrane is reinforced by impregnating from the non-mesothelial side.

11. The heart valve prosthesis according to claim 8, wherein said reinforcement is provided by inserting a polymeric material, between the two layers of biological membrane forming the leaflet or leaflets.

12. The heart valve prosthesis according to claim 11, wherein said reinforcing polymeric material is in the form of filaments.

13. The heart valve prosthesis according to claim 1, wherein at least in the region forming the leaflets the strip is stretched in the folding direction prior to the placing on the base material.

14. The heart valve prosthesis according to claim 1, wherein the strip of biological membrane after the folding and the formation of at least one leaflet is shaped to a tube, the longitudinal axis of which is disposed substantially perpendicularly to the folding lines.

15. A heart valve prosthesis according to claim 1 for use as an aortic valve prosthesis comprising three tongue-shaped leaflets each of which being formed by folding a strip of a biological membrane along a folding line, attaching on either side a narrow tape-shaped base material of a flexible nonbiological material serving as attachment margins, removing the portion of the membrane located outside the attachment margins and stitching together said leaflets in pairs along a section of the attachment margins to form a three-leaflet valve.

19. The heart valve prosthesis according to claim 5, wherein the polymeric material is a crocheted material.

20. The heart valve prosthesis according to claim 1, wherein the biological membrane is calf pericardium.

16. A method of producing a heart valve prosthesis comprising the steps of folding a flat strip piece of biological membrane along at least one folding line to form opposed layers and stitching the strip on a flat flexible non-biological base material to form at least one leaflet.

17. The method according to claim 16 comprising the steps of folding the strip along two parallel folding lines, stitching the strip on the base material, forming three leaflets and further stitching the marginal regions together in order to form a tube the longitudinal axis of which is disposed substantially perpendicularly to the folding lines.

18. A method of producing an aortic valve prosthesis comprising the steps of folding a strip of a biological membrane along a folding line, stitching a tongue-shaped attachment margin of a tape-shaped flexible non-biological material to either side of the membrane, removing the excess portion of the membrane, stitching the obtained tongue-shaped leaflet together with two leaflets produced in the same manner along a section of the respective attachment margins to form a three-leaflet valve.