Transcatheter prosthetic heart valve delivery system and method with expandable stability tube

摘要

A device for percutaneously delivering a stented prosthetic heart valve. The device includes an inner shaft assembly, a delivery sheath assembly, an outer stability tube, and a handle. The sheath assembly is slidably disposed over the inner shaft, and includes a capsule and a shaft. The capsule compressively contains the prosthesis over the inner shaft. The stability tube is slidably disposed over the delivery sheath, and includes a distal region configured to be radially expandable from a first shape having a first diameter to a second shape having a larger, second diameter. In a first delivery state, the distal region assumes the first shape, providing a low profile appropriate for traversing a patient's vasculature. In a second delivery state, the distal region has the expanded diameter second shape, sized to receive the capsule, such as when retracting the capsule to implant the prosthesis.

主权项

1. A delivery device for percutaneously delivering a stented prosthetic heart valve, the prosthetic heart valve being radially self-expandable from a compressed arrangement to a normal, expanded arrangement, the delivery device comprising:
an inner shaft assembly including a coupling structure configured to selectively engage a stented prosthetic heart valve; a delivery sheath assembly slidably disposed over the inner shaft assembly and including a distal capsule and a proximal shaft, wherein the capsule is circumferentially rigid and is configured to compressively contain a stented prosthetic heart valve in a compressed arrangement; an outer stability tube slidably disposed over the delivery sheath assembly, the stability tube including a proximal region and a distal region, the distal region including a tubular wall configured to be radially expandable from a first shape having a first diameter to a second shape having a second diameter, the second diameter being greater than the first diameter; and a handle including a housing maintaining the inner shaft assembly, the delivery sheath assembly and the stability tube, the handle being operable to selectively move the delivery sheath assembly relative to the inner shaft assembly and the stability tube; wherein the delivery device is configured to provide a first delivery state in which the coupling structure is positioned within the capsule and the distal region is proximal the capsule and in the first shape, and a deployed state in which the capsule is at least partially withdrawn into the distal region and the distal region is in the second shape; and further wherein the delivery device is configured such that from the first delivery state, the distal region is caused to radially expand from the first shape to the second shape solely in response to locating the capsule within the distal region.