Devices and methods for the treatment of heart failure

Inventors

Celermajer, David Stephen

Assignees

Corvia Medical Inc

Abstract

A device for treating heart failure in a patient. The device comprising a body, at least one passage through the body, at least one one way valve in the passage and a mounting means adapted for mounting the body in an opening provided in the patient's atrial septum. In use, the device is oriented such that, when the patient's left atrial pressure exceeds the patient's right atrial pressure by a predetermined amount, the one way valve(s) opens to allow blood flow through the passage(s) from the left atrium to the right atrium to thereby reduce the left atrial pressure.

Core Innovation

The invention provides a device for treating a heart condition in a patient using a Nitinol mesh body adapted and configured to self-expand from a radially collapsed configuration to an expanded configuration. In the expanded configuration, the body includes a first flange and a second flange with exterior faces and interior faces, and a central portion extending between the flanges. The interior faces of the first and second flanges define an annular gap surrounding the central portion, and the interior and exterior face diameters change gradually with distance from the central portion and between the interior and exterior faces.

The device further includes a centrally located passage having a diameter of about 4–15 mm extending through the first and second flanges and the central portion. The body is configured to be delivered percutaneously to a patient's heart in the radially collapsed condition in which the exterior faces of the first and second flanges are separated, thereby causing the device to lengthen and reduce in diameter. The device self-expands in an opening in a septum of the heart so that the first flange is disposed in the left atrium, the second flange is disposed in the right atrium, and the central portion is located in the opening.

With the first flange in the left atrium and the second flange in the right atrium, the central portion permits blood to flow from the left atrium to the right atrium. In the described embodiments, treatment of heart failure is achieved by reducing elevated left atrial pressure through a one-way valve arrangement that opens when left atrial pressure exceeds right atrial pressure by a predetermined differential. The disclosure also describes optional thrombi prevention features such as a mesh or grill arrangement with small apertures and optional drug coatings.

The disclosure states multiple embodiment implementations including Nitinol expandable stent/mesh versions and different mounting and delivery schemes, including septal mounts using flanges and venous system versions. The device is delivered percutaneously in a collapsed and expanded configuration and is positioned using the septum opening to permit left-to-right blood flow while optionally excluding thrombosis using mesh/grill structures and drug coatings.

Claims Coverage

The provided independent claim set out a percutaneous, self-expanding Nitinol mesh device that is deployed through a septum opening to enable controlled left-to-right blood flow between the left atrium and right atrium. The inventive features concentrate on a specific Nitinol mesh/flange geometry, a centrally located passage sized to permit blood flow, and placement via flanges in the left and right atria.

Across the independent claim, the core coverage is a self-expanding Nitinol mesh body with first and second flanges configured for percutaneous deployment through a septum opening, a central passage sized about 4–15 mm, and placement such that blood flows from the left atrium to the right atrium.

Stated Advantages

Documented Applications