Edwards Lifesciences Corporation

Thanh Huy Le

Tung Thanh Le

Sonny Tran

Richard D White

Alpana Kiran Gowdar

Pu Zhou

Michael G Valdez

Erik E Bulman

Yidong M Zhu

Baigui Bian

Timothy A Geiser

David Mark Taylor

David D Williams

Yong Gao

Sam Sok

Robert R Bowes

Tri D Tran

Brian C Gray

Henry Bourang

David J Evans

Ronaldo C Cayabyab

Mario M Iobbi

Matthew T Winston

Kim D Nguyen

Gilbert Madrid

Kevin D Rupp

Michael D Franklin

Rajesh A Khanna

Eric Robert Dixon

Gregory Scott Tyler, Ii

Michael C Murad

Alejandro J Froimovich Rosenberg

Antonio O Vidal

Jeff Lindstrom

Hamid Rafi

Uy D Trinh

Neal H Avery

Maria Lillian Saravia

Sovanpheap Mak

Kim Le

Andrew Oien

David M Taylor

Rajesh Khanna

Maria L Saravia

Sean Chow

Michael R Bialas

Grant Matthew Stearns

Gil Senesh

Praveen De Silva

Tung T Le

Robert Bowes

Mario Iobbi

Mario M Gabriel Iobbi

Tam Van Nguyen

Kristen Hicks

Dave J Evans

Daniel James Montoya

Haley Nicole Whitehead

Nicholas Brandon Aders

Mario Gabriel Iobbi

Gregory Scott Tyler

Bobert Bowes

David Taylor

David John Loos

A delivery apparatus for implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart includes a handle portion and a balloon catheter assembly comprising an elongated balloon catheter shaft extending from the handle portion. The balloon catheter shaft includes a proximal end portion coupled to the handle portion and a distal end portion. The balloon catheter assembly further includes a balloon coupled to the distal end portion and configured to mount a prosthetic heart valve in a radially compressed state. A protective cover encapsulates the balloon, the cover defining a cavity shaped to accommodate the balloon.

Delivery system for prosthetic heart valve

Catheterization methods and apparatuses allow sensing of pressures inside the heart and for removing air from catheters. A delivery system can use the same components that are used to deliver a valve repair or replacement device to measure the pressure in the atrium or other heart chamber. A pressure sensor can be included in one of the catheters of the delivery system or pressure can be sensed through the same port that is used to flush a catheter. The delivery system can be inserted into the heart, delivering the valve repair or replacement device to the native valve, such as the mitral valve, the tricuspid valve, the aortic valve, or the pulmonary valve.

Catheterization method and apparatus

A method of implanting a prosthetic heart valve includes advancing a distal end portion of a catheter shaft through a patient's vasculature. The distal end portion of the catheter shaft includes an expansion device. A prosthetic heart valve is mounted on the expansion device with the expansion device and the prosthetic heart valve in a compressed configuration. The method further includes positioning the distal end portion of the catheter shaft and the prosthetic heart valve to an implantation location and expanding the prosthetic heart valve and the expansion device to an expanded configuration. The expansion device includes a main body and a plurality of projections extending radially from the main body. The projections are spaced apart relative to each such that there are grooves extending between adjacent projections providing perfusion passageways between the expansion device and the prosthetic heart valve when the expansion device is in the expanded configuration.

Stability device for use with percutaneous delivery systems

Disclosed herein are expandable introducer sheaths and methods of making and using the same. The sheaths minimize trauma to a patient's vasculature by allowing for temporary expansion of a portion of the sheath to accommodate passage of a delivery system for an implant, then return to a non-expanded state after the passage of the device. The sheath includes a foldable inner member having a detached flap structure at its distal tip that facilitates expansion of the sheath lumen to increased diameters, and an elastomeric distal end that reduces push and retrieval forces therethrough. The sheath can include a hemostasis seal on its proximal end to prevent the leakage of blood out of the sheath and prevent ballooning of outer layer of the sheath.

Expandable sheath and methods of using the same

A delivery sheath includes an outer tubular layer and an initially folded inner tubular layer. When an implant passes therethrough, the outer tubular layer expands and the inner tubular layer unfolds into an expanded lumen diameter. The sheath may also include selectively placed longitudinal support rods that mediate friction between the inner and outer tubular layers to facilitate easy expansion, thereby reducing the push force needed to advance the implant through the sheath's lumen.

Expandable sheath

A valve catheter is advanced through a patient's vasculature while a prosthetic heart valve is attached to flexible extensions along a distal end thereof. The valve catheter is advanced through a tubular sleeve for exposing the prosthetic heart valve and allowing the prosthetic heart valve to self-expand while the extensions remain attached to the prosthetic heart valve. A release mechanism on a handle portion is actuated for releasing the prosthetic heart valve from the extensions, thereby implanting the prosthetic heart in a native heart valve. If the operator is not satisfied with the initial expansion, the prosthetic heart valve may be reoriented before release from the extensions by retracting the prosthetic heart valve back into the tubular sleeve, adjusting the orientation of the prosthetic heart valve and then re-advancing the valve catheter from the tubular sleeve for allowing the prosthetic heart valve to re-self-expand at a more desirable location.

Method of implanting a heart valve

Disclosed embodiments of introducer devices provide hemostatic sealing and allow a delivery catheter to be inserted through the introducer seals without the use of a separate loader device that covers a medical device that is mounted on the catheter. Some disclosed introducers comprise a housing, a distal sheath extending distally from the housing and adapted to be inserted into a patient's vasculature, a distal hemostatic seal mounted within the housing and a proximal hemostatic seal mounted within the housing, and a slidable tube positioned within the housing that is movable longitudinally relative to the distal hemostatic seal between a proximal position and a distal position, wherein in the proximal position a distal end of the tube is positioned proximal to the distal hemostatic seal with the distal hemostatic seal closed, and wherein in the distal position the distal end of the tube extends through the distal hemostatic seal.

Intravascular introducer devices

Devices and methods for crimping a prosthetic heart valve onto a delivery device are described. In some embodiments, valves are crimped over an inflatable balloon and between proximal and distal shoulders mounted on a shaft inside the balloon. Crimping methods can include multiple compression steps with the valve located in different axial positions relative to the crimping jaws at each different step. In some methods, the valve may extend partially outside of the crimping jaws during certain crimping steps, such that the crimping force is only applied to the part of the valve that is inside the jaws. Exemplary crimping devices can include two or more adjacent sets of jaws that close down to different inner diameters, such that different parts of a valve get compressed to different outer diameters at the same time during a single crimping step.

Crimping devices and methods

A method of implanting a prosthetic heart valve includes advancing a distal end portion of a catheter shaft through a patient's vasculature. The distal end portion of the catheter shaft includes an expansion device. A prosthetic heart valve is mounted on the expansion device with the expansion device and the prosthetic heart valve in a compressed configuration. The method further includes positioning the distal end portion of the catheter shaft and the prosthetic heart valve to an implantation location, and expanding the prosthetic heart valve and the expansion device from the compressed configuration to an expanded configuration. The expansion device includes an inner expandable member and a plurality of outer expandable members. The outer expandable members are distributed such that there are gaps providing perfusion passageways between the expansion device and the prosthetic heart valve when the expansion device is in the expanded configuration.

A delivery apparatus for implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart includes a handle portion and an elongated shaft extending from and movable relative to the handle portion. The shaft includes a proximal end portion coupled to the handle portion and a distal end portion configured to mount a prosthetic heart valve in a radially compressed state. The handle portion includes a control member movable longitudinally with respect to the handle portion, the control member engaging a gear assembly operable to convert longitudinal motion of the control member to rotational motion of the gear assembly. The gear assembly engages the elongated shaft such that rotational motion of the gear assembly causes corresponding longitudinal motion of the elongated shaft relative to the handle portion.

A delivery sheath includes an elastic outer tubular layer and an inner tubular layer having a thick wall portion integrally connected to a thin wall portion. The inner tubular layer can have a compressed or folded condition wherein the thin wall portion folds onto an outer surface of the thick wall portion under urging of the elastic outer tubular layer. When an implant passes therethrough, the outer tubular layer stretches and the inner tubular layer unfolds into an expanded lumen diameter. Once the implant passes, the outer tubular layer again urges the inner tubular layer into the compressed condition with the sheath reassuming its smaller profile. The sheath may also include selectively placed longitudinal rods that mediate friction between the inner and outer tubular layers to facilitate easy expansion and collapse, thereby reducing the push force needed to advance the implant through the sheath's lumen.

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Oceanside, CA, United States of America

Thanh Huy Le