Natural tissue heart valve fixation process

• US 4,247,292 A
• Filed: 06/06/1979
• Issued: 01/27/1981
• Est. Priority Date: 06/06/1979
• Status: Expired due to Term

• Current Assignee: William W. Angell
• Original Assignee: William W. Angell
• Inventors: Angell, William W.
• Primary Examiner(s): Schofer, Joseph L.
• Assistant Examiner(s): Lilling, Herbert J.
• Application Number:
  US06/046,100
• Time in Patent Office: 601 Days
• Field of Search: 8/94.11, 3/1, 3/1.5
• US Class Current: 8/94.11
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• 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 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A process for fixing a natural tissue heart valve whereby the valve has improved hydraulic performance is disclosed. The valve is first placed in glutaraldehyde with the valve cusps kept in the closed position by applying hydraulic pressure to the ventricular side of the valve. The valve is then trimmed and fitted to and sutured into a fabric covered plastic stent. An expandable tube is then placed axially within the valve and expanded to force the valve cusps into an open position. The expanded tube-valve-stent assembly is then placed in glutaraldehyde to further fix the valve and predispose the valve cusps to an open position.

Claims

1. Process for fixing a natural tissue heart valve prosthesis comprising:

(a) contacting the valve with a fixing agent with the valve cusps in a closed position so as to partially fix the valve such that the configuration and dimensions of the valve are substantially set; and

(b) thereafter contacting the valve with the fixing agent with the valve cusps in an open position whereby the valve is further fixed and the valve cusps are predisposed to an open position.

2. The process of claim 1 wherein the valve is a porcine valve.

3. The process of claim 2 wherein the fixing agent is an aqueous solution of glutaraldehyde.

4. The process of claim 3 wherein the glutaraldehyde concentration in the solution is 0.5 % by weight.

5. The process of claim 4 wherein in step (a) the valve is contacted with the glutaraldehyde solution for about four hours and in step (b) the valve is contacted with the glutaraldehyde solution for about four hours.

6. The process of claim 1 wherein the valve is packed with a packing material to hold the valve cusps in a closed position in step (a).

7. The process of claim 1 wherein hydraulic pressure is applied to ventricular side of the valve to hold the valve cusps in a closed position in step (a).

8. The process of claim 1 wherein the valve is fitted to and affixed within a stent between steps (a) and (b).

9. The process of claim 1 wherein an expandable member is placed axially within the valve and expanded therein to hold the valve cusps in an open position in step (b).

10. Process for fixing a porcine heart valve prosthesis comprising:

(a) contacting the valve with an aqueous solution of glutaraldehyde with the valve cusps in a closed position for a time sufficient to partially fix the valve and substantially set the configuration and dimensions of the valve;

(b) fitting and affixing the valve within a stent; and

(c) contacting the valve-stent assembly with an aqueous solution of glutaraldehyde with the valve cusps in an open position for a time sufficient to further fix the valve and predispose the valve cusps to an open position.

11. The process of claim 10 wherein hydraulic pressure is applied to the ventricular side of the valve to hold the valve cusps in a closed position in step (a) and an expandable member is placed axially within the valve and expanded therein to hold the valve cusps in an open position in step (c).