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.

A growth stent and valve and methods for making and using the same. The growth stent and valve may be delivered to treat early stage congenital lesions, while expanding to adult vessel diameters. In selected embodiments, the growth stent and valve can comprise a frame and may have a covering on some portion to prevent blood flow through a wall of the frame. The growth stent and valve advantageously can maintain radial strength across an entire range of diameters necessary to treat a narrowed lesion from birth and childhood through adulthood as the vessels grow over the lifetime of a patient.

A prosthetic valve has a radially expandable and compressible frame including a plurality of interconnected struts and a valvular structure including a plurality of leaflets configured to regulate the flow of blood through the prosthetic valve. The leaflets can have undulating cusp edge portions. The prosthetic valve further includes at least one connecting skirt having a shape that corresponds to the cusp edge portion of at least one leaflet. The connecting skirt can connect the cusp edge portion of the leaflet to at least one of the struts of the frame. The connecting skirt can include a first set of yarns intersecting with a second set of yarns. The first and second sets of yarns can extend at oblique angles relative to a longitudinal axis of the at least one strut.

A crimper includes atop iris shell defining atop iris channel. The crimper also includes abase iris shell coupled to the top iris shell at a pivot connection, the base iris shell defining a base iris channel. The top iris shell is configured to rotate about the pivot connection relative to the base shell from an open state to a closed state. When in the open state, the base iris channel is exposed for loading the expandable medical device. When in the closed state, the top iris channel and the base iris channel define a crimper chamber. The crimper also includes a handle configured to operate the clamshell crimper. The actuation of the handle decreases a volume of the crimper chamber to transition the expandable medical device from the uncompressed state to the compressed state.

A delivery system for an expandable prosthetic heart valve is provided. The delivery system includes an elongate inner member, a distal stop and a proximal stop both disposed on the elongate inner member. At least one of the proximal and distal stops is fixed to the elongate inner member. The delivery system also includes a flexible member disposed around the elongate inner member and having a distal end, a central region, and a proximal end, and an inflatable balloon disposed over the flexible member. The flexible member is configured such that when a heart valve is crimped onto the central region, the central region compresses and proximal and distal regions of the flexible member expand radially to prevent axial movement of the valve.

A delivery system is provided for delivering an expandable medical device. The delivery system includes a catheter shaft, a proximal stop coupled to the catheter shaft, an inner tube coupled to the proximal stop and extending distally therefrom, a distal stop coupled to the inner tube, and a balloon disposed over the distal stop, the inner tube, and the proximal stop. The inner tube defines an inflation lumen and has a plurality of openings extending through a sidewall of the inner tube into the inflation lumen. The distal stop includes at least one channel extending through a sidewall of the distal stop into the lumen. The distal stop is configured to allow inflation fluid to flow through the inner tube and the at least one channel into a distal region of the balloon.

A quick-connect heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The heart valve includes a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable frame, thereby enabling attachment to the annulus without sutures. A small number of guide sutures may be provided for aortic valve orientation. The prosthetic valve may be a commercially available valve with a sewing ring with the frame attached thereto. The frame may expand from a conical deployment shape to a conical expanded shape, and may include web-like struts connected between axially-extending posts. A system and method for deployment includes an integrated handle shaft and balloon catheter. A valve holder is stored with the heart valve and the handle shaft easily attaches thereto to improve valve preparation steps.

An inflatable balloon includes a base balloon having a cylindrical section and a conical section and at least one circumferential fiber extending circumferentially around the conical section. The inflatable balloon includes a plurality of reinforcing strips in the conical section over the at least one circumferential fiber. Each reinforcing strip includes a plurality of fibers extending at an angle relative to the at least one fiber. Each reinforcing strip is positioned a set circumferential distance away from a neighboring reinforcing strip.

A valved endoprosthesis releasing device and a valved endoprosthesis pertaining to the medicine area, more particularly a device for releasing valved endoprosthesis specifically developed for the combined endovascular treatment of aortic valve disease and ascending aorta segment, said device allowing the assembly to travel endovascularly until the valved endoprosthesis is specifically coupled to repair injured segments of the ascending aorta and replace the calcified aortic valve, besides restoring the anatomy and assuring the consolidation of a suitable blood flow in the region to be treated. The invention comprises a valved endoprosthesis releasing device consisting of several overlapped tubular segments, wherein the movement of the sheath tube releases the valved endoprosthesis coupled to the proximal region for endovascular implantation by expanding the balloon or self-expanding a valved endoprosthesis provided with a tubular body coupled to an aortic valve.

Prosthetic heart valves are described. Prosthetic heart valves can include radially expandable and compressible inner and outer metal frames. The inner frame can be disposed within a lumen of the outer frame and can be coupled to the outer frame. An outflow end of the inner frame can be coupled to and/or located at an outflow end of the outer frame. An end portion of the inner frame can be spaced radially inwardly from an inner surface of the outer frame, such that a radial gap exists between the inner surface of the outer frame and an outer surface of the inner frame. Prosthetic heart valves can further include a plurality of leaflets disposed within and supported by the inner frame, such as by commissure posts of the inner frame.