Systems, methods and devices for delivery systems, methods and devices for implanting prosthetic heart valves

Inventors

Chambers, Jeffrey W. • Brucker, Gregory G. • Higgins, Joseph P. • Kumar, Saravana B. • Diedering, Jason S. • Kabarowski, Karl A. • Thatcher, Robert J. • Flaherty, James E. • Stone, Jeffrey R.

Assignees

4C Medical Technologies Inc

Abstract

Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.

Core Innovation

The invention provides a method of delivering a self-expanding prosthetic mitral valve device having prosthetic mitral valve leaflets to an implantation site within a left atrium of a patient's heart. A delivery catheter accesses the left atrium with a proximal end, a distal end, and a lumen therethrough, and the prosthetic mitral valve device is loaded in a collapsed configuration into the lumen at the proximal end. The collapsed prosthetic mitral valve device is delivered out of the distal end of the delivery catheter into the left atrium at a location proximate the implantation site.

After delivery, the self-expanding prosthetic mitral valve device expands within the left atrium at the implantation site. At least a portion of the expanded prosthetic mitral valve device engages at least a portion of an upper annular surface within the left atrium while not engaging a left ventricle of the patient's heart. The collapsed prosthetic mitral valve device includes a proximal portion and a distal portion, wherein the prosthetic mitral valve leaflets are disposed within the distal portion.

The method further includes loading an inner sheath into the delivery catheter lumen such that the inner sheath distal end engages the collapsed self-expanding prosthetic mitral valve device. Translation of the inner sheath through the delivery catheter lumen results in translation of the collapsed self-expanding prosthetic mitral valve device, which includes a one-chamber stented valve, through the delivery catheter lumen. The inner sheath includes a lumen therethrough sized to receive the proximal portion of the collapsed self-expanding prosthetic mitral valve device.

Related subject matter describes staged or inner-sheath translation, diameter relationships among a proximal portion, a central portion, and a distal portion, positioning mechanisms that include an alignment wire engaging an open frame portion of the prosthetic mitral valve device and a left upper pulmonary vein, restraining expansion into a partially expanded configuration using at least one capture wire, curving a distal end of the delivery catheter using a pull wire and a weakened section, and using a plug that engages the left atrial appendage when the device is expanded.

Claims Coverage

The partial content explicitly provides one independent claim. It describes a delivery method with staged sheath interaction, followed by self-expansion such that engagement is limited to an upper annular surface without engaging the left ventricle. Dependent claim features are also partially described in the provided claim list but are not themselves independently presented here.

The provided independent claim centers on delivering a collapsed self-expanding prosthetic mitral valve into the left atrium via a delivery catheter, expanding at an implantation site to engage an upper annular surface without engaging the left ventricle, and translating the collapsed device through the catheter lumen using an inner sheath whose lumen is sized to receive the proximal portion. The provided partial dependent-claim summaries further indicate additional placement or alignment, diameter-relationship constraints, expansion restraint, catheter curving, and plug-based left atrial appendage engagement.

Stated Advantages

Documented Applications