Edwards Lifesciences Corporation

Baxter International Inc.

David J Evans

David Mark Taylor

Ronaldo C Cayabyab

Christopher Chia

Robert R Bowes

Robert Milich

Philippe Marchand

David L Swendson

Henry Bourang

Tri D Tran

Thanh Huy Le

Sean Chow

Sam Sok

Robert Royal Bowes

Rajesh A Khanna

Mario M Iobbi

Tamir S Levi

David Zarbatany

Thomas R Findlay, Iii

Wesley M Morris

W Scott Couchman

Robert A Pecor

Donald E Bobo, Jr

Luchy D Roteliuk

Timothy C Mills

Mark A Konno

Rajesh Khanna

James D Fonger

Charles R Mooney

Clifford Currier

Lucien Attal

Mario M Gabriel Iobbi

Howard Taymor-Luria

Clifford E Currier

David M Taylor

Mario Gabriel Iobbi

Christoper Chia

Robert Milich Jr

Assemblies and delivery apparatus for delivering a medical device into a patient's vasculature are disclosed. In some examples, an assembly includes a delivery apparatus and a radially compressible and expandable prosthetic heart valve. The delivery apparatus includes a handle, a first shaft and a second shaft extending from the handle, and a locking mechanism to prevent axial movement of the second shaft relative to first shaft. The second shaft extends coaxially through the first shaft and includes, at a distal end portion thereof, a balloon, one or more radiopaque markers, and the prosthetic valve radially compressed over the balloon. A flared end piece extending from the first shaft covers a proximal portion of the balloon during advancing of the delivery apparatus through a patient's vasculature. The first shaft is retractable relative to the second shaft to expose the balloon from the flared end piece.

Delivery apparatus for prosthetic heart valve

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

Embodiments of the present disclosure provide an introducer device and methods for introducing a medical device into a patient's vasculature. In one embodiment, a method of using an introducer device including a housing, a hemostatic seal mounted within the housing, and a tube extending into the housing and movable longitudinally relative to the hemostatic seal between a proximal position and a distal position, includes moving the tube to the distal position such that the distal end of the tube extends through the hemostatic seal. The method further includes inserting a distal end portion of the medical device through the tube and into the patient's vasculature without contacting the hemostatic seal.

Introducer device for medical procedures

A delivery apparatus for a prosthetic heart valve includes a shaft, an inner balloon, and an outer balloon. The shaft has a lumen extending from a proximal end portion to a distal end portion and a plurality of openings formed in the distal end portion. The shaft is configured such that a fluid can flow through the lumen and the openings. The inner balloon has end portions and a center portion disposed between the end portions. The inner balloon is mounted on the distal end portion of the shaft and is in fluid communication with the openings of the shaft. When the inner balloon is inflated with the fluid, the end portions expand farther radially outwardly than the center portion. The outer balloon is mounted to the shaft and disposed over the inner balloon. The outer balloon is configured to fully expand after the inner balloon at least partially expands.

Delivery systems for prosthetic heart valve

A method for replacing a stenotic native aortic valve of a patient can include inserting a delivery apparatus into a femoral artery of the patient, the delivery apparatus having a first shaft extending from the handle, a second shaft disposed around the first shaft, a third shaft extending through the second shaft, and a valve cover coupled to the first shaft. The valve cover can be in a first state housing an entirety of a prosthetic heart valve and retaining the prosthetic heart valve in a radially compressed state during the act of inserting. The method can further include advancing the delivery apparatus through the aorta of the patient to position the valve cover and the prosthetic heart valve within the native aortic valve, and moving the valve cover longitudinally from the first state to a second state in which the entirety of the prosthetic heart valve is uncovered.

Embodiments of the present disclosure provide a delivery apparatus for a prosthetic heart valve. Disclosed delivery apparatuses can include a handle, a first shaft extending from the handle, a second shaft disposed around the first shaft, and a valve cover. The valve cover can be coupled to a distal end portion of the first shaft and can be configured to house a prosthetic heart valve in a radially compressed state. The valve cover can have an outer diameter greater than an outer diameter of the second shaft, and the first shaft and valve cover can be movable together in an axial direction relative to the second shaft.

Embodiments of the present disclosure provide an introducer device for introducing a medical device into a patient's vasculature. In one embodiment, the introducer device comprises a housing, a distal sheath adapted to be inserted into a patient's vasculature with the housing positioned outside of the patient's vasculature, a hemostatic seal mounted within the housing, and a tube positioned within the housing and movable longitudinally relative to the hemostatic seal between a proximal position and a distal position. In the proximal position, a distal end of the tube is positioned proximal to the hemostatic seal with the hemostatic seal closed. In the distal position, the distal end of the tube extends through the hemostatic seal and permits the medical device to be inserted through the housing and into the patient's vasculature without contacting the hemostatic seal.

Embodiments of the present disclosure provide a delivery apparatus for a prosthetic heart valve. Disclosed steerable catheters can include a handle, a steerable shaft extending from the handle, and a pull wire. The shaft can include a main lumen, an inner polymeric layer surrounding the main lumen, a braided layer surrounding the inner polymeric layer, and an outer polymeric layer surrounding the braided layer, the outer polymeric layer defining a pull wire lumen. The pull wire can extend from the handle and through the pull wire lumen and can have a distal end portion coupled to a distal end portion of the shaft.

Embodiments of the present disclosure provide an introducer device and method for introducing a delivery apparatus into a patient's vasculature. Disclosed methods can include positioning a sleeve of an introducer sheath in a blood vessel of a patient, the sleeve having a lattice layer with a lumen therethrough, inserting a distal end portion of the delivery apparatus and a prosthetic heart valve into the lumen, and advancing the distal end portion of the delivery apparatus through the lumen from the proximal end to the distal end. The method can then include expanding the lumen from a first diameter smaller to a second diameter at least equal to the diameter of the prosthetic heart valve to allow passage of the prosthetic heart valve through the lumen, and returning the lumen of the sleeve to a diameter smaller than the second diameter after advancing the prosthetic heart valve through the lumen.

Embodiments of the present disclosure provide a delivery apparatus for a prosthetic heart valve. Disclosed delivery apparatuses can include a housing, a steerable shaft, a slide nut, and a threaded shaft disposed over the slide nut. The slide nut can have an external threaded surface and an internal surface comprising a slot. The threaded shaft can have an internal threaded surface engaging the external threaded surface of the slide nut. The delivery apparatus can further include an elongated nut guide extending into the slot of the nut to restrain the slide nut against rotation relative to the housing, and a pull wire having a proximal end portion extending into the housing and coupled to the slide nut, and a distal end portion coupled to a distal end portion of the steerable shaft. The threaded shaft can be rotatable relative to the housing to produce axial movement of the slide nut within the threaded shaft.

An assembly for treating a native valve in a human heart includes a prosthetic heart valve having an expandable frame and a valvular structure. The assembly also includes a tubular sleeve and a valve catheter disposed within the sleeve. A plurality of metal extension arms are coupled to the valve catheter for holding the prosthetic heart valve. The extension arms are configured to radially expand with the prosthetic heart valve during expansion of the prosthetic heart valve at a treatment site. A plurality of metal rods extend distally from the valve catheter. The rods are axially movable relative to the extension arms. A plurality of release members are provided for releasing the prosthetic heart valve from the extension arms upon movement of the metal rods.

Heart valve delivery system with valve catheter

An assembly includes a prosthetic heart valve and a delivery apparatus for implanting the prosthetic heart valve within the native aortic valve of a patient. The prosthetic heart valve has a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent. The delivery apparatus has a handle, a first shaft having a proximal end portion and a distal end portion, a second shaft extending co-axially through the first shaft and having a proximal end portion and a distal end portion, the proximal end portions of the first and second shafts extending distally from the handle, a valve cover coupled to the distal end portion of the first shaft, and a nose piece coupled to the distal end portion of the second shaft.

Integrated heart valve delivery system

Embodiments of the present disclosure provide a delivery apparatus for delivering a prosthetic heart valve to a native valve site via the human vasculature without the need for a separate introducer sheath. The delivery apparatus is particularly well-suited for advancing a prosthetic valve through the aorta (i.e., in a retrograde approach) for replacing a stenotic aortic valve.

Growing community of inventors

Irvine, CA, United States of America

David J Evans