US 12,201,734 B2
Method for sterilizing heart valves
Steven M. Claessens, Santa Rosa, CA (US); and Rachel Ann Cooney, Costa Mesa, CA (US)
Assigned to EDWARDS LIFESCIENCES CORPORATION, Irvine, CA (US)
Appl. No. 17/054,505
Filed by Edwards Lifesciences Corporation, Irvine, CA (US)
PCT Filed Oct. 8, 2018, PCT No. PCT/US2018/054845
§ 371(c)(1), (2) Date Nov. 10, 2020,
PCT Pub. No. WO2019/074838, PCT Pub. Date Apr. 18, 2019.
Claims priority of provisional application 62/572,277, filed on Oct. 13, 2017.
Prior Publication US 2021/0187135 A1, Jun. 24, 2021
Int. Cl. A61L 2/00 (2006.01); A61F 2/02 (2006.01); A61L 2/18 (2006.01); A61L 27/36 (2006.01); C08J 3/28 (2006.01)
CPC A61L 2/007 (2013.01) [A61L 2/18 (2013.01); A61L 27/3687 (2013.01); A61L 2202/181 (2013.01); A61L 2202/21 (2013.01)] 20 Claims
OG exemplary drawing
 
1. A method of sterilizing a prosthetic heart valve, the method comprising:
radially compressing a compressible frame of a heart valve from an expanded configuration to an at least partially crimped configuration, the heart valve comprising the frame and a plurality of leaflets coupled to the frame, wherein each of the plurality of leaflets comprises a dry, unfixed, decellularized pericardial tissue, wherein the tissue has not been treated with a cross-linking fixative solution;
packaging the compressed heart valve within a sealed packaging system; and
sterilizing the compressed heart valve packaged within the sealed packaging system with one or more cycles of electron beam radiation.