Edwards Lifesciences Corporation

Sonny Tran

Tung Thanh Le

Richard D White

Alpana Kiran Gowdar

Pu Zhou

Michael G Valdez

Erik E Bulman

Baigui Bian

David D Williams

Alejandro J Froimovich Rosenberg

Robert R Bowes

Hamid Rafi

Sovanpheap Mak

Kim D Nguyen

Michael C Murad

Thanh Huy Le

Yidong M Zhu

Timothy A Geiser

Yong Gao

Brian C Gray

Uy D Trinh

Maria Lillian Saravia

Andrew Oien

Kevin D Rupp

Jeff Lindstrom

Praveen De Silva

Haley Nicole Whitehead

Neal H Avery

David John Loos

A system for introducing a delivery apparatus into a patient's vasculature. The system may include a sheath having a lumen and configured to be inserted into the patient's vasculature. An introducer has a channel for receiving a guide wire and is configured to be positioned within the lumen of the sheath. A plug is coupled to the introducer and is configured to move from a first position in which the plug has a first diameter to a second position in which the plug has a second diameter that is greater than the first diameter and greater than the interior diameter of the sheath, the plug being configured to slide within the lumen in a direction from the distal end of the sheath towards the proximal end of the sheath to expand the sheath in the direction radially outward from the lumen.

Introducer sheath with expandable introducer

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

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

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.

Delivery system for prosthetic heart valve

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.

An expandable introducer sheath for passage of implant delivery catheters, such as catheters for delivery of prosthetic heart valves. The expandable sheath balances the amounts, shapes and positions of various stiff and elastic structures in the sheath to selectively program the expandability and buckling stiffness of the sheath. The expandable sheath can include, for example, an expandable tubular layer that includes alternating stiff and elastic wall portions of a single radial thickness. The combination of stiff and elastic wall portions allow for torque and push strength to advance the expandable sheath while at the same time accommodating temporary expansion. The expandable sheath can also be reinforced with a tubular layer of braided fibers or a stent structure for additional strength. Other embodiments include selective use of slots or gaps at the distal end of a stiff wall portion to enhance expandability and distribute strain.

Expandable sheath with elastomeric cross sectional portions

Growing community of inventors

Westminster, CA, United States of America

Sonny Tran