Prosthetic mitral valve with improved atrial and/or annular apposition and paravalvular leakage mitigation

Inventors

Kumar, Saravana B. • Kruse, Steven D. • Stone, Jeffrey R.

Assignees

4C Medical Technologies Inc

Abstract

The present invention provides a prosthetic heart valve device with improved fit and/or apposition between the device frame and left atrial tissue and/or the device base and the annular tissue of the left atrium to improve shifting of the implanted device and/or mitigate paravalvular leakage. The improved fit and/or apposition arises in various embodiments by providing or allowing an asymmetrical frame and/or frame base and/or providing a lower lip to aid in conforming to the asymmetrical shape of the atrium and/or ensure firm positioning therein. An additional benefit of these arrangement(s) is mitigation of paravalvular leakage as a result of improved fit and seal. In certain embodiments, the asymmetry of the frame assists with delivery of the device into the atrium.

Core Innovation

The invention relates to a device for expanded implantation into the left atrium of a patient’s heart. The device includes an expandable stent frame comprising a posterior section and an anterior section, and a base section comprising a posterior section and an anterior section. The valve support is adapted for supporting at least one prosthetic valve, and the stent frame is configured to engage the left atrium when implanted and expanded.

In the described configuration, the posterior section and the anterior section of the expandable stent frame are symmetrically shaped relative to each other. A lip extends at least partially around a portion of the base section, with the lip extending radially outwardly away from the base section. When the device is implanted and expanded, the base section is configured to engage annular tissue of the left atrium, and the lip is configured to engage the annular tissue of the left atrium.

The document further describes PVL mitigation by improving conformance and frictional engagement between the device and asymmetric left atrial anatomy and annulus. This includes constructions featuring an asymmetrical stent frame and/or asymmetrical base, and a lower/radially extending posterior lip or ridge that increases conformance and engagement to reduce device shifting. The document also explains asymmetry as aiding directional delivery and recapture in the atrium.

Additional PVL mitigation is described using hydrophilic sealing skirt or base coverage materials that swell after implantation. Hydrophilic materials are described as being integrated into multi-layer skirt constructions with pocket and subpocket structures, and as being encapsulated in breakable/dissolvable/biodegradable/bioerodable/bioabsorbable nanoparticles for delayed swelling. The document also describes delaying hydrophilic material exposure using thin biodegradable/dissolvable overcoat films that enable subsequent exposure of the hydrophilic material upon liquid exposure.

Claims Coverage

The independent claim covers a left-atrial expandable prosthetic mitral valve device with an expandable stent frame, a base section, and a radially outwardly extending lip that engage the left atrium and annular tissue when implanted and expanded. The independent claim includes the key requirement that the posterior and anterior sections of the stent frame are symmetrically shaped relative to each other, and that both the base section and the lip engage annular tissue.

Overall, the claim coverage focuses on a left atrial expandable prosthetic valve device where a symmetrically shaped anterior/posterior expandable stent frame engages the left atrium, and a radially outwardly extending lip together with a base section engages annular tissue of the left atrium to support PVL mitigation.

Stated Advantages

Documented Applications