Guidewireless transseptal delivery system and method

Inventors

Stack, Richard S • Athas, William L • Johnson, Kevin W

Assignees

Synecor LLC

Abstract

A system and method used to deliver a valve delivery system carrying a valve to a target valve annulus in the heart includes a cable percutaneously introduced into a vasculature of a patient and positioned to run from a femoral vein, transseptally through the heart, to a femoral artery. The valve delivery system device is passed over an end of the cable at the arterial side and is secured to the cable. The valve delivery system device is pushed in a distal direction while the venous end of the cable is pulled in the proximal direction, to advance the valve delivery system to the target valve annulus. A left ventricle redirector positionable on the cable from the venous end has a distal end actively steered during advancement and positioning of the valve delivery device, exerting forces that steer the distal nose of the valve delivery device as it moves towards the valve annulus.

Core Innovation

The invention relates to a method of delivering a therapeutic device to a target treatment site at a valve annulus in a heart of a patient by introducing a cable into vasculature and routing the cable from a femoral vein, through the heart via a transseptal puncture, to a femoral artery. A heart valve delivery device carrying a replacement valve is secured to the cable at the femoral artery, and a left ventricle redirector (LVR) having a tubular lumen is advanced over the cable to the left ventricle.

The method advances the therapeutic device to the target treatment site by pulling the cable at the femoral vein while pushing the therapeutic device at the femoral artery. During this advancement, the distal end of the LVR is actively steered such that steering modifies an orientation of a distal nose of the therapeutic device. The active steering is performed while advancing the device to the valve annulus, after which the replacement valve is deployed at the valve annulus.

In the left ventricle, the LVR is positioned to actively steer and orient the device during advancement, including modifying a distal orientation of the distal nose of the therapeutic device. Dependent refinements specify that the LVR can form a distal curve and that the orientation outcome can be a generally D-shaped arrangement associated with steering the pullwire and the LVR structure. Other refinements further specify LVR positioning into the left ventricle, including seating an edge of the curve in the apex of the left ventricle and applying a distal force to press the curve into the apex during advancement.

Claims Coverage

The document includes one independent claim and dependent claims that refine delivery to a specific valve annulus type and constrain the LVR steering and positioning mechanics. Across the independent claim, the coverage centers on percutaneous cable routing via transseptal puncture, securing and advancing a replacement-valve delivery device using coordinated pulling and pushing, and actively steering the LVR to modify the orientation of a distal nose prior to deployment.

Overall, the claim set is directed to delivering a heart valve replacement valve to a valve annulus using a percutaneous transseptal cable conduit, where a left ventricle redirector is advanced to the left ventricle and actively steered during coordinated pulling and pushing to modify the distal nose orientation before deploying the replacement valve.

Stated Advantages

Documented Applications

No documented applications found