US 11,730,597 B2
Prosthetic heart valve and delivery apparatus
David Alon, Zichron Yaacov (IL); Netanel Benichou, D.n. Hof Hacarmel (IL); and Oded Meiri, Ram-On (IL)
Assigned to EDWARDS LIFESCIENCES CORPORATION, Irvine, CA (US)
Filed by Edwards Lifesciences Corporation, Irvine, CA (US)
Filed on Jan. 26, 2023, as Appl. No. 18/102,024.
Application 18/102,024 is a continuation of application No. 17/158,458, filed on Jan. 26, 2021.
Application 17/158,458 is a continuation of application No. 16/997,890, filed on Aug. 19, 2020, granted, now 10,932,906, issued on Mar. 2, 2021.
Application 16/997,890 is a continuation of application No. 16/743,316, filed on Jan. 15, 2020, granted, now 10,806,575, issued on Oct. 20, 2020.
Application 16/743,316 is a continuation of application No. 15/953,991, filed on Apr. 16, 2018, granted, now 10,952,848, issued on Mar. 23, 2021.
Application 15/953,991 is a continuation of application No. 15/181,243, filed on Jun. 13, 2016, granted, now 10,238,487, issued on Mar. 26, 2019.
Application 15/181,243 is a continuation of application No. 14/182,169, filed on Feb. 17, 2014, granted, now 9,364,325, issued on Jun. 14, 2016.
Application 14/182,169 is a continuation of application No. 12/429,040, filed on Apr. 23, 2009, granted, now 8,652,202, issued on Feb. 18, 2014.
Claims priority of provisional application 61/091,293, filed on Aug. 22, 2008.
Prior Publication US 2023/0172714 A1, Jun. 8, 2023
Int. Cl. A61F 2/24 (2006.01); A61F 2/95 (2013.01)
CPC A61F 2/2436 (2013.01) [A61F 2/2418 (2013.01); A61F 2/2439 (2013.01); A61F 2/9517 (2020.05); A61F 2/9522 (2020.05); A61F 2002/9528 (2013.01); A61F 2002/9534 (2013.01); A61F 2210/0076 (2013.01); A61F 2220/005 (2013.01); A61F 2220/0075 (2013.01); A61F 2230/001 (2013.01); A61F 2230/0054 (2013.01); A61F 2230/0076 (2013.01); A61F 2250/0039 (2013.01)] 20 Claims
OG exemplary drawing
 
1. An assembly for transvascular replacement of a native aortic heart valve, the assembly comprising:
a radially collapsible and self-expandable prosthetic heart valve comprising:
an annular frame made of a shape-memory material, the frame comprising a plurality of posts extending from a proximal end portion of the frame, wherein each of the posts comprises an axial post portion extending from the proximal end portion of the frame and a terminal post portion at the proximal end of the axial post portion, wherein the terminal post portion has a greater circumferential dimension than the axial post portion; and
a valve structure disposed within an interior of the frame; and
a delivery apparatus comprising:
an inner shaft comprising a valve connection portion that is releasably coupled to the posts of the prosthetic heart valve, wherein the valve connection portion comprises a plurality of discrete radially facing recesses, wherein each of the posts is positioned in a respective one of the recesses, wherein each of the recesses comprises an axial recess portion that receives the axial post portion of the respective post and an enlarged recess portion that receives the terminal post portion of the respective post, wherein each of the enlarged recess portions is defined by a curved wall formed in the valve connection portion, the curved wall extending partially around the corresponding terminal post portion, wherein for each of the recesses the enlarged recess portion has a circumferential dimension that is greater than the axial recess portion, and wherein the circumferential dimension of the terminal post portions is greater than the axial recess portions such that the posts cannot move axially out of the recesses;
an outer shaft positioned around the inner shaft, the outer shaft comprising a valve sheath at a distal end, the valve sheath being positioned around the prosthetic heart valve and the valve connection portion of the inner shaft, wherein the valve sheath maintains the prosthetic heart valve in a radially compressed state and maintains the posts within the recesses for delivery to a native aortic heart valve region; and
a handle comprising a housing, a screw shaft, a control knob that is rotatable relative to the housing and the screw shaft, and a screw engagement latch that is adjustable between an engaged position and a disengaged position, wherein in the engaged position the latch couples the control knob to the screw shaft such that rotation of the control knob relative to the housing causes the outer shaft to move axially relative to the housing, and in the disengaged position the latch decouples the control knob from the screw shaft such that the outer shaft can move axially relative to the housing without rotation of the control knob;
wherein when the latch is in the engaged position, rotation of the control knob in a first direction relative to the housing causes the valve sheath to move proximally relative to the prosthetic heart valve;
wherein rotation of the control knob in the first direction to a first position causes the valve sheath to uncover a distal majority of the prosthetic heart valve, while still covering the posts and maintaining the posts within the recesses, which allows the prosthetic heart valve to radially self-expand from the radially compressed state to a partially radially expanded state where the posts remain connected to the valve connection portion of the inner shaft; and
wherein further rotation of the control knob in the first direction from the first position to a second position causes the valve sheath to uncover the posts, which allows the prosthetic heart valve to radially self-expand from the partially radially expanded state to a fully radially expanded state, such that expansion of the prosthetic heart valve moves the posts radially out of the recesses, which releases the prosthetic heart valve from the delivery apparatus.