Devices and methods for retrievable intra-atrial implants

Inventors

Sugimoto, Hiroatsu • Forcucci, Stephen J. • McNamara, Edward I. • Finch, Matthew J. • Magnin, Christopher J.

Assignees

Corvia Medical Inc

Abstract

Devices and methods to enhance the implantation, retrievability, or repositionability are provided. Embodiments of devices include pivotable sections providing the ability to maintain the device's engagement with a delivery system during implantation where the deliver system approaches an opening of the septum at an angle. Embodiments of devices also include configurations that allow for improved retrieval into a delivery system in the event that a malfunction or a problem with the patients physiology is detected.

Core Innovation

The invention provides a percutaneously deliverable device for treating a heart condition in an atrial septum of a patient. The device includes a first flange section and a second flange section, each comprising a plurality of flange segments spaced about a longitudinal axis of the device and configured to be positioned on opposing sides of the atrial septum. The first flange section includes a proximal portion of each flange segment with a pivotable section joined to form a proximal hub.

The pivotable sections allow the proximal hub to be curved, bent, turned, or twisted relative to the first flange section as the first and second flange sections are deployed across and conform to the atrial septum. The pivotable sections and a pivotable end connecting the proximal end of the first flange are adapted to provide non-zero angle rotational displacement relative to the longitudinal axis of the device, including non-zero angle up to 180 degree rotational displacement angle. The proximal hub is configured to be curved while the device is conforming to the atrial septum geometry during deployment.

The disclosure further describes releasably engaging the device with a delivery catheter, advancing the device to a septal wall, positioning the flanges on opposing sides, and deploying the device while conforming to the septal wall. It also describes repositionable/retrievable use with clinician-directed determination and conditional release during deployment, as well as coronary sinus pressure relief concepts involving coronary sinus stents, a left atrium-coronary sinus opening, and one-way/check valve configurations.

Claims Coverage

The independent claims cover three distinct aspects: structural configuration with pivotable hub-based flange segments, a delivery and deployment method with catheter engagement and pivoting away from the device longitudinal axis, and a pivotable end with non-zero rotational displacement up to 180 degrees. The inventive features emphasize percutaneously deliverable opposing-side flange positioning and pivoting or rotational displacement to conform to the atrial septum.

Collectively, the claims define percutaneously deliverable atrial-septum treatment devices and a corresponding deployment method in which opposing-side flange sections and a pivotable structure enable curvature, bending, turning, twisting, or rotational displacement relative to the longitudinal axis during deployment and conforming to the atrial septum.

Stated Advantages

Documented Applications