Devices, systems, and methods to treat heart failure having an improved flow-control mechanism

Inventors

McNamara, Edward • Celermajer, David • Forcucci, Stephen J. • Sugimoto, Hiroatsu • Finch, Matthew J.

Assignees

Corvia Medical Inc

Abstract

Several unique intra-cardiac pressure vents, placement catheters, methods of placement and methods of treating heart failure are presented. The intra-cardiac pressure vents presented remain partially open under normal intra-cardiac pressures to allow sufficient flow from the left atrium to the right atrium to enable the relief of elevated left atrial pressure and resulting patient symptoms, and also limit the amount of flow from the right atrium to the left atrium by closing when the pressure in the right atrium exceeds the pressure in the left atrium by a predetermined amount.

Core Innovation

The invention relates to an implantable interatrial pressure venting device and delivery system configured to treat a heart condition in a patient by regulating flow between the left atrium and the right atrium. The device is configured to be implanted into the atrial septum and includes a cylindrical core segment defining a passage, a first annular flange adapted to engage a first surface of the atrial septum, and a second annular flange adapted to engage a second surface of the atrial septum opposite the first surface.

A flow control element is provided as part of the device to control interatrial flow in response to a pressure differential between the left atrium and the right atrium. The flow control element is adapted to be partially open when the pressure in the left atrium is equal to the pressure in the right atrium, and to close when the pressure in the right atrium is greater than the pressure in the left atrium by at least 2 mm Hg. The flow control element extends over a radially inner portion of the second annular flange so that it overlaps the radially inner portion of the second annular flange.

The document describes structural variations for the venting device and delivery features, including configurations in which the flow control element is a valve with different valve behavior, such as flappable during the cardiac cycle and resonating with the cardiac cycle. It also describes thrombus or embolus mitigation and delivery/deployment concepts that support stowing and deployment of the flanges, as well as repositioning or retrievability, and optional flow aiming toward selected regions.

Claims Coverage

The partial content includes one independent claim directed to an implantable device for treating a heart condition by regulating interatrial flow using a pressure-responsive, partially open/closed flow control element overlapped with an annular flange. Dependent claims refine the flow control element and the spatial arrangement of the atrial septum surfaces, including specifying the flow control element as a valve and adding cardiac-cycle-related valve behaviors.

Across the independent claim and its dependents, the coverage centers on an atrial septum-implanted device with a cylindrical core passage, dual annular flanges engaging opposite septal surfaces, and a pressure-responsive flow control element that is partially open under equal left/right atrial pressures and closes when the right atrial pressure exceeds the left by at least 2 mm Hg, with the flow control element overlapping a radially inner portion of the second annular flange. Dependent features specify the flow control element as a valve and add flappable and resonating behavior with the cardiac cycle, along with further positioning of the septal surfaces.

Stated Advantages

Documented Applications