US 12,465,484 B2
Method of treating mitral valve stenosis
Boaz Manash, Givat Ada (IL); Khen Perlmutter, Binyamina (IL); Adi Carmi, Ganei Tikva (IL); Noa Axelrod Manela, Netanya (IL); and Nikolay Gurovich, Hadera (IL)
Assigned to EDWARDS LIFESCIENCES CORPORATION, Irvine, CA (US)
Filed by Edwards Lifesciences Corporation, Irvine, CA (US)
Filed on Aug. 9, 2021, as Appl. No. 17/397,727.
Application 17/397,727 is a continuation of application No. 16/442,165, filed on Jun. 14, 2019, granted, now 11,083,571.
Claims priority of provisional application 62/690,481, filed on Jun. 27, 2018.
Prior Publication US 2021/0361417 A1, Nov. 25, 2021
Int. Cl. A61F 2/24 (2006.01)
CPC A61F 2/2409 (2013.01) [A61F 2/2418 (2013.01); A61F 2/2427 (2013.01); A61F 2230/0093 (2013.01)] 20 Claims
OG exemplary drawing
 
1. A method of treating valve stenosis in a native valve of a human heart of a patient, the method comprising:
advancing a delivery apparatus through a patient's vasculature to a native valve having a calcified annulus, the delivery apparatus including a prosthetic heart valve disposed on a distal end portion of the delivery apparatus in a radially collapsed state, the prosthetic heart valve comprising a metallic, annular inner frame, an outer frame radially outward of the inner frame and sutured to the inner frame, the outer frame comprising an atrial portion and a ventricular portion, the outer frame comprising a plurality of tissue-engaging elements positioned on an exterior surface of the outer frame, the inner frame comprising a leaflet structure for replacing the function of the native valve, the leaflet structure positioned between first and second ends of the metallic inner frame, the prosthetic heart valve comprising an inflow end and an outflow end;
radially expanding the prosthetic heart valve to an expanded state within the calcified annulus of the native valve such that the atrial portion of the outer frame is positioned in an atrium of the heart and extends upwardly beyond an inflow end of the inner frame, wherein at least some of the tissue-engaging elements of the prosthetic heart valve engage the calcified annulus, and wherein a diameter of the outer frame of the prosthetic heart valve increases from a first diameter at the outflow end to a second diameter moving in an upstream direction toward the inflow end; and
removing the delivery apparatus from the patient's vasculature;
wherein, after radial expansion, the prosthetic heart valve is retained within the calcified annulus of the native valve and the leaflet structure replaces the function of the native valve.