Edwards Lifesciences Corporation

Christopher J Olson

Alexander J Siegel

Lauren R Freschauf

Emil Karapetian

Alison S Curtis

Cristobal R Hernandez

Glen Thomas Rabito

Dustin P Armer

Netanel Benichou

Asher L Metchik

Matthew T Winston

William Charles Brunnett

Gregory I Bak-Boychuk

David Mark Taylor

Stanton J Rowe

Kevin M Stewart

Devin H Marr

Minh T Ma

Hiroshi Okabe

Philip P Corso, Jr

Maria Charles Vija Stanislaus

Cheng-Tung Huang

Eric Robert Dixon

Sergio Delgado

Mark Chau

Alexander H Cooper

Tri D Tran

Bao Khuu

David Leigh Hauser

Thomas V Doherty

Yoon Hee Kwon

Carl A Swindle

Charles Stanislaus

Ian Shakil

Pooja Sharma

Alex Siegel

Mark Huang

Chris Janovsky

Hsingching Crystal Hsu

Erin Glines

Maria Charles Stanislaus

Philip P Corso

This application relates to methods, systems, and apparatus for replacing native heart valves with prosthetic heart valves and treating valvular insufficiency. In a representative embodiment, a support frame configured to be implanted in a heart valve comprises a main body formed by formed by a plurality of inner members forming an inner clover and a plurality of outer members forming an outer clover. The support frame can include gaps located between inner members of the plurality of inner members and outer members of the plurality of outer members. The inner clover can be radially inside the outer clover, and the outer clover can have larger dimensions than the inner clover. The support frames herein can be radially expandable and collapsible.

Valvular insufficiency repair device and method

Prosthetic heart valve assemblies and methods, apparatus, and systems used to deliver a prosthetic heart valve assembly. A prosthetic heart valve assembly includes an inner frame, a prosthetic leaflet section disposed within the inner frame extending between in inflow row of cells and an outflow row of cells of the inner frame, and an outer support stent. The inner frame is disposed within the outer support stent, and the outer support stent is coupled and/or fastened to the inner frame. The outer support stent includes a plurality leaflet capturing arms for capturing native leaflets between the leaflet capturing arms and a portion of the prosthetic heart valve assembly when the prosthetic heart valve assembly is implanted in a native valve. For example, the native leaflets can be frictionally secured between the leaflet capturing arms of the support stent and the inner frame.

Retaining mechanisms for prosthetic valves

A delivery apparatus includes a steerable guide sheath. The steerable guide sheath has a steerable portion, a pull ring located in the distal portion, and a pull wire coupled at one end to the pull ring and coupled at the opposite end to a control handle. The pull wire extends longitudinally through a pull-wire conduit. The steerable guide sheath further includes a compression-resistance portion made of metal and located in the distal portion.

Apparatus for the introduction and manipulation of multiple telescoping catheters

This application relates to methods, systems, and apparatus for replacing native heart valves with prosthetic heart valves and treating valvular insufficiency. In some implementations, a heart valve leaflet clipping mechanism includes a delivery apparatus and clipping arms. The clipping arms are coupled to the delivery apparatus. The clipping arms are movable between an open position and a closed position. The two clipping arms are biased to the closed position. The delivery apparatus is configured to hold the clipping arms in the open position. The delivery apparatus is configured to allow the clipping arms to move to the closed position to engage native heart valve leaflet tissue.

In one representative embodiment, an implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion. The prosthetic device can be movable between multiple configurations. The spacer body can be configured to extend radially outwardly as the spacer body extends away from the distal end toward the proximal end. A delivery apparatus can have a first shaft and a second shaft, wherein movement of the first shaft relative to the second shaft moves the anchor portion relative to the spacer body.

Heart valve sealing devices and delivery devices therefor

Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support structure and an expandable prosthetic valve are advanced through the aortic arch of a patient using a delivery system. The support structure is delivered to a position on or adjacent to the surface of the outflow side of the aortic valve (the support structure defining a support-structure interior). The expandable prosthetic valve is delivered into the aortic valve and into the support-structure interior. The expandable prosthetic heart valve is expanded while the expandable prosthetic heart valve is in the support-structure interior and while the support structure is at the position on or adjacent to the surface of the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the support structure and the expanded prosthetic heart valve.

In one representative embodiment, an implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion. The prosthetic device can be movable between multiple configurations. The spacer body can be made from braided, self-expandable metallic thread. A delivery apparatus can have a first shaft and a second shaft, wherein movement of the first shaft relative to the second shaft moves the anchor portion relative to the spacer body.

Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve assembly. In embodiments, a prosthetic heart valve assembly, including a self-expandable support structure and a self-expanding heart valve, are advanced through the aortic arch of a patient using a delivery system. The support structure, which includes a plurality leaflet retaining arms, is at least partially expanded and positioned on or adjacent to the outflow side of the aortic valve. The prosthetic heart valve is positioned in the aortic valve. The prosthetic heart valve is expanded while it is within an interior of the support structure and while the support structure is positioned on or adjacent to the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the arms of the support structure and the expanded prosthetic heart valve.

In a representative embodiment, a method comprises implanting first and second inflatable bodies within an annulus of a native heart valve by securing the inflatable bodies to tissue of the native heart valve with sutures, and implanting a prosthetic heart valve between the inflatable bodies such that the prosthetic heart valve is retained within the annulus by the inflatable bodies.

Prosthetic heart valve docking assembly

A delivery apparatus includes a steerable shaft having a pull-wire conduit. A pull wire extends through the pull-wire conduit. The steerable shaft includes one or more layers. A compression-resistance portion is incorporated into at least one of the one or more layers. A cross-section of the compression-resistance portion has an arcuate shape that extends along a portion of a cross-section of the steerable shaft. The compression-resistance portion has a hardness that is greater than a hardness of the one or more layers that the compression-resistance portion is incorporated into.

In a representative embodiment, an implantable assembly for a native heart valve comprises a prosthetic heart valve and first and second inflatable bodies. The prosthetic heart valve can comprise a frame and prosthetic leaflets. The first inflatable body can comprise first and second end portions, wherein the first end portion is configured to be secured to tissue of the native heart valve at a first location, and the second end portion is configured to engage an outer surface of the prosthetic valve. The second inflatable body can comprise third and fourth end portions, wherein the third end portion is configured to be secured to tissue of the native heart valve at a second location, and the fourth end portion is configured to engage the outer surface of the prosthetic valve. The first and second inflatable bodies anchor the prosthetic valve within the annulus of the native heart valve.

A delivery apparatus includes a steerable shaft having a proximal portion, a distal portion, and a pull-wire conduit that extends through the proximal and distal portions. A pull wire extends through the conduit and has a distal portion that is fixed to the shaft. An adjustment mechanism is connected to the proximal end portion of the pull wire and configured to increase and decrease tension in the pull wire to adjust the curvature of the shaft. The distal portion of the shaft has a steerable portion including one or more layers. A compression-resistance portion is incorporated into a layer of the steerable portion, and extends angularly along a portion of a cross-section of the layer. The layer of the steerable portion into which the compression-resistance portion is incorporated has a first hardness, and the compression-resistance portion has a second hardness that is greater than the first hardness.

In one representative embodiment, an implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion, wherein the prosthetic device is movable between a compressed configuration, in which the spacer body portion is radially compressed and is axially spaced relative to the anchor portion, and an expanded configuration, in which the spacer body portion expands radially outwardly relative to the compressed configuration and overlaps at least a portion of the anchor portion.

Growing community of inventors

Aliso Viejo, CA, United States of America

Christopher J Olson