US 11,944,537 B2
Systems, methods and devices for two-step delivery and implantation of prosthetic heart valve
Jeffrey W. Chambers, Maple Grove, MN (US)
Assigned to 4C Medical Technologies, Inc., Maple Grove, MN (US)
Filed by 4C Medical Technologies, Inc., Maple Grove, MN (US)
Filed on Feb. 17, 2020, as Appl. No. 16/792,389.
Application 16/792,389 is a continuation of application No. 15/876,664, filed on Jan. 22, 2018, granted, now 10,561,495.
Claims priority of provisional application 62/449,713, filed on Jan. 24, 2017.
Prior Publication US 2020/0179115 A1, Jun. 11, 2020
This patent is subject to a terminal disclaimer.
Int. Cl. A61F 2/24 (2006.01); A61F 2/958 (2013.01)
CPC A61F 2/2427 (2013.01) [A61F 2/2418 (2013.01); A61F 2/2412 (2013.01); A61F 2/958 (2013.01); A61F 2220/0008 (2013.01); A61F 2250/006 (2013.01)] 13 Claims
OG exemplary drawing
 
1. A two-step method of delivering a prosthetic mitral valve device comprising a self-expanding prosthetic mitral valve frame and a prosthetic mitral valve comprising prosthetic mitral valve leaflets to an implantation site within a left atrium of a patient's heart for supplementing and/or replacing native mitral valve leaflet functionality, comprising:
accessing the left atrium by transseptal access with a delivery catheter having a proximal end, a distal end and a lumen therethrough;
loading the self-expanding prosthetic mitral valve frame in a collapsed configuration into the lumen of the delivery catheter at the proximal end thereof;
delivering the collapsed self-expanding prosthetic mitral valve frame out of the distal end of the delivery catheter and into the left atrium at a location proximate the implantation site;
allowing the delivered self-expanding prosthetic mitral valve frame to expand within the left atrium at the implantation site, wherein at least a portion of the expanded self-expanding prosthetic mitral valve frame engages at least a portion of an upper annular surface within the left atrium, a surface defined by walls within the left atrium and a surface of a roof within the left atrium;
loading the prosthetic mitral valve comprising prosthetic mitral valve leaflets into the lumen of the delivery catheter and delivering the prosthetic mitral valve out of the distal end of the delivery catheter and into the expanded self-expanding prosthetic mitral valve frame; and
positioning and connecting the prosthetic mitral valve to the prosthetic mitral valve connection region of the expanded prosthetic mitral valve frame; wherein:
the left ventricle and the native mitral valve leaflets are not touched at any point by the prosthetic mitral valve device or the delivery catheter; and
the connected prosthetic valve is positioned above the native mitral valve leaflets such that the native mitral valve leaflet functionality is not interfered with by the connected prosthetic valve and is at least partially supplemented by the prosthetic mitral valve leaflets.