US 11,051,925 B2
Method and system for packaging and preparing a prosthetic heart valve and associated delivery system
Vipul P. Rajpara, Lake Forest, CA (US); Darshin S. Patel, San Juan Capistrano, CA (US); Michael R. Bialas, Lake Forest, CA (US); Brian R. Lowry, Fullerton, CA (US); Russ Hunton, Newport Beach, CA (US); and Arvin T. Chang, Yorba Linda, CA (US)
Assigned to Edwards Lifesciences Corporation, Irvine, CA (US)
Filed by Edwards Lifesciences Corporation, Irvine, CA (US)
Filed on Jul. 9, 2019, as Appl. No. 16/506,912.
Application 16/506,912 is a division of application No. 15/250,759, filed on Aug. 29, 2016, granted, now 10,350,047.
Claims priority of provisional application 62/213,536, filed on Sep. 2, 2015.
Prior Publication US 2019/0358018 A1, Nov. 28, 2019
This patent is subject to a terminal disclaimer.
Int. Cl. A61F 2/00 (2006.01); A61F 2/24 (2006.01); A61B 50/33 (2016.01); A61M 5/00 (2006.01); B65D 1/34 (2006.01); A61B 50/00 (2016.01); B65D 77/26 (2006.01); B65D 25/10 (2006.01)
CPC A61F 2/0095 (2013.01) [A61F 2/2427 (2013.01); A61B 50/33 (2016.02); A61B 2050/005 (2016.02); A61B 2050/0082 (2016.02); A61B 2050/0083 (2016.02); A61F 2/2412 (2013.01); A61F 2/2436 (2013.01); A61F 2240/001 (2013.01); A61M 5/002 (2013.01); B65D 1/34 (2013.01); B65D 25/10 (2013.01); B65D 77/26 (2013.01)] 26 Claims
OG exemplary drawing
 
1. A method for preparing a prosthetic valve and its associated delivery system for implantation of the prosthetic valve in a patient, the method comprising:
(a) obtaining a tray, the tray containing a prosthetic valve in a first compressed state and coupled to an elongated delivery system, the tray comprising:
a cavity comprising an open end, a floor, and a peripheral side wall defining a depth of the cavity, the cavity sized and shaped to house the prosthetic valve and at least part of a distal portion of the elongated delivery system;
a mounting surface to substantially immobilize and maintain the prosthetic valve within the cavity; and
an engaging surface peripherally of the cavity, the engaging surface securing at least a part of the elongated delivery system externally of the cavity;
(b) at least partially filing the cavity with a first hydrating fluid to completely immerse the prosthetic valve;
(c) allowing the prosthetic valve to soak in the first hydrating fluid for a period of time;
(d) flushing the elongated delivery system by delivering a second hydrating fluid into a proximal end of the elongated delivery system and causing the second hydrating fluid to pass through a lumen extending through the elongated delivery system and out of the distal portion of the elongated delivery system;
(e) causing the prosthetic valve to be loaded into a lumen of a delivery sheath associated with the elongated delivery system while the prosthetic valve is coupled to the cavity floor via the mounting surface;
wherein the loading is performed by causing the delivery sheath to move axially over the prosthetic valve;
wherein the delivery sheath compresses and contains the prosthetic valve within a lumen of the delivery sheath in a second compressed state; and
wherein a diameter of the prosthetic valve in the first compressed state is larger than a diameter of the prosthetic valve in the second compressed state; and
(f) removing the elongated delivery device with the prosthetic valve loaded into the lumen of the delivery sheath from the tray, including disengaging the prosthetic valve from the mounting surface; and
wherein (a) through (e) are performed while the prosthetic valve is substantially immobilized and maintained within the cavity.