Delivery system for aided replacement valve recapture and repositioning post-deployment

Inventors

Srinimukesh, Harish Manickam • Oba, Travis Zenyo • Landon, David Robert • Rabito, Glen T.

Assignees

Edwards Lifesciences Corp

Abstract

Disclosed herein are embodiments of a delivery system which can be used to recapture and/or reposition a replacement valve, such as a replacement mitral valve, after initial deployment of the valve. Embodiments of the delivery system can involve a torqueing manifold that interacts with multiple tethers that are releasably coupled to eyelets of a replacement heart valve. Engagement pins may be configured to releasably retain one end of the tethers.

Core Innovation

The disclosure describes a delivery system configured for release and recapture of an implant using a plurality of tethers and a torqueing manifold. The torqueing manifold is located on a distal end of a manifold shaft, configured to retain a first end of each of the plurality of tethers, located radially inwards of a self-expanding replacement heart valve, and located within a lumen of a locking shaft. The self-expanding replacement heart valve includes a plurality of eyelets through which the plurality of tethers extend.

The delivery system provides engagement pins configured to move from a locked position to an unlocked position so that translation of the engagement pins releases the second end of each of the plurality of tethers and releases the replacement heart valve from the delivery system. After release, rotating the manifold shaft tightens the plurality of tethers to crimp a distal end of the replacement heart valve to recapture the replacement heart valve following release. An outer elongate hollow member shaft is configured to cover the replacement heart valve when the replacement heart valve is in a collapsed state to facilitate recapture following release.

The disclosure also provides for release and recapture by using rotational directions of the manifold shaft. Rotating the manifold shaft in a first circumferential direction loosens the plurality of tethers to uncrimp a distal end of the replacement heart valve to release the replacement heart valve. Rotating the manifold shaft in a second circumferential direction opposite the first circumferential direction tightens the plurality of tethers to crimp the distal end to recapture the replacement heart valve.

Claims Coverage

Two independent claims are described: one configured for translation of engagement pins with tether release followed by rotating the manifold shaft for recapture, and another configured to release and recapture by rotating the manifold shaft in opposite circumferential directions to uncrimp and crimp a distal end.

Across the independent claims, the core claim coverage centers on using tethers carried through valve eyelets, a torqueing manifold that tightens tethers to crimp and recapture, and a release mechanism that either translates engagement pins to release tether ends and the valve or rotates the manifold shaft in opposite circumferential directions to loosen/uncrimp for release and tighten/crimp for recapture.

Stated Advantages

Documented Applications

No documented applications found