Self-expanding heart assist device
Inventors
Criscione, John C. • Bolch, Christina M. • Leschinsky, Boris
Assignees
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Abstract
The present invention includes a device and method for a self-expanding framework device adapted to facilitate the deployment of an extra-cardiac device. The device includes a deployment tube and a self-expanding wire framework having a structure that results in the self-expanding wire framework circumferential flaring motion and bending outwardly to advance around the heart.
Core Innovation
The invention relates to a minimally invasive extra-cardiac/heart-assist delivery system that uses a deployment tube and a self-expanding articulated wire framework covered by a biocompatible polymer film. The framework is deployed from a deployment aperture into a thoracic cavity and is adapted to flare outwardly to encircle a portion of a heart.
A set of adjacent articulated wire loops extend from a hub, and each loop includes a top segment positioned at a lead edge and extending to a left midway bend and a right midway bend. Each loop also includes a left strut extending from the left midway bend to the hub and a right strut extending from the right midway bend to the hub, with a connector linking the left strut to the right strut of the loop.
The top segment, left midway bend, and right midway bend result in a tension that causes each adjacent articulated wire loop to engage in a circumferential flaring motion and bend outwardly as the self-expanding framework is deployed. Variants are described in the geometry and arrangement of the midway bends and wire loops, including rounded midway bends, flattened midway bends, multiple bends, adjacent loops versus partially overlapping wire loops, and configurations for polymer film placement inside, outside, or as a sandwich relative to the framework.
Claims Coverage
The identified independent claims are one device claim and one method claim, both centered on a tension-driven, self-expanding articulated wire framework adapted to circumferentially flare outward to encircle a portion of a heart without guidewires, using a deployment tube/aperture mechanism to enable controlled deployment.
Adjacent articulated wire loops with tension-driven circumferential flaring
A self-expanding wire framework adapted to flare outwardly to encircle a portion of a heart comprising a set of adjacent articulated wire loops extending from a hub, wherein each of the adjacent articulated wire loops includes a top segment positioned at a lead edge and extending to a left midway bend and to a right midway bend, a left strut extending from the left midway bend to the hub, and a right strut extending from the right midway bend to the hub, and a connector linking the left strut to the right strut of each adjacent articulated wire loop, wherein the top segment, the left midway bend and the right midway bend result in a tension that causes each adjacent articulated wire loop to engage in a circumferential flaring motion and bend outwardly as the self-expanding framework is deployed.
Deployment tube insertion and outward flaring deployment about the heart
A method for implanting a self-expanding framework delivery device about a heart comprising providing a deployment tube having an outer surface surrounding an inner passage and a deployment aperture at one end of the inner passage, providing a self-expanding wire framework adapted to flare outwardly to encircle a portion of a heart comprising adjacent articulated wire loops from a hub with a top segment, left midway bend, right midway bend, left strut, right strut, and a connector linking the left strut to the right strut such that the top segment, left midway bend and right midway bend result in a tension that causes each adjacent articulated wire loop to engage in a circumferential flaring motion and bend outwardly as the self-expanding framework is deployed, inserting the deployment tube into the thoracic cavity, deploying the self-expanding wire framework from the deployment aperture, moving the left midway bend and the right midway bend from the deployment aperture to allow a circumferential flaring motion and bend outwardly as the self-expanding framework is deployed, and extending the self-expanding wire framework from the deployment aperture to encircle at least a portion of the heart.
Across the independent claims, the core inventive coverage is the same mechanical concept: a self-expanding articulated wire framework where defined top segments and left/right midway bends create tension to produce circumferential flaring and outward bending, with deployment enabled by a deployment tube/aperture and the controlled movement of the left and right midway bends from the deployment aperture during deployment.
Stated Advantages
Shorter implantation.
Less invasive implantation.
Reduced guidewire entanglement.
Reduced infection risk.
Documented Applications
Congestive heart failure (CHF) support, including passive and active fluid-chamber concepts and fluid ports with pneumatic actuation.
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