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 disclosed invention relates to a minimally invasive heart-assist delivery concept using a self-expanding wire framework adapted to flare outwardly to encircle a portion of a heart. A polymer film is in contact with the self-expanding wire framework for deployment around the heart while the wire framework is deployed from a deployment tube. The self-expanding wire framework comprises a set of adjacent articulated wire loops that extend from a lead edge to a hub.
Each articulated wire loop includes a top segment positioned at the lead edge and extending to a left midway bend and a right midway bend. A left strut extends from the left midway bend to the hub, and a right strut extends from the right midway bend to the hub, with a fixed strut attachment point on the hub to fix the position of the left strut and the right strut. Adjacent articulated wire loops interlace the right strut of a first loop with the left strut of an adjacent loop.
The left midway bend and the right midway bend result in a tension that causes the set of articulated wire loops to engage in a circumferential flaring motion and to bend outwardly as the framework and polymer film are deployed from the deployment tube. The staged flaring is described as occurring during tube egress and continues as the framework extends to encircle the portion of the heart. The polymer film can be positioned on the inside, outside, or both inside and outside of the self-expanding wire framework.
Claims Coverage
The independent claims cover a polymer-covered self-expanding wire framework with adjacent articulated wire loops and left/right midway bends that generate tension and circumferential outward flaring during deployment, a deployment-tube configuration for extension from a deployment aperture, and a method of implantation in which the framework is inserted into the thoracic cavity and bent outwardly to flare about the apex and encircle a heart portion. Three inventive features are set out across the independent claims.
Circumferential outward flaring self-expanding wire framework with polymer film
A self-expanding wire framework adapted to flare outwardly to encircle a portion of a heart, with a polymer film in contact with the self-expanding wire framework for deployment around the heart.
Adjacent articulated wire loops from lead edge to hub with fixed strut attachment point
A set of adjacent articulated wire loops extending from a lead edge to a hub, where each articulated wire loop comprises a top segment positioned at the 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, a right strut extending from the right midway bend to the hub, and a fixed strut attachment point on the hub to fix the position of the left strut and the right strut.
Interlaced adjacent loops via strut interlacing and tension-driven flaring during tube deployment
Each articulated wire loop interlaces the right strut of a first articulated wire loop with the left strut of an adjacent articulated wire loop, and the left midway bend and right midway bend result in a tension that causes the set of articulated wire loops to engage in a circumferential flaring motion and bend outwardly as the self-expanding framework is deployed from a deployment tube and the polymer film is deployed.
Deployment tube with inner passage and deployment aperture for slidably extending the polymer-covered framework
A deployment tube having an outer surface surrounding an inner passage and a deployment aperture at one end of the inner passage, and a self-expanding wire framework adapted to flare outwardly to encircle a portion of a heart, covered with a polymer film and slidably positioned in the inner passage to slidably extend from the deployment aperture.
Thoracic cavity implantation method with outward bending at midway bends to flare about heart apex
A method for implanting a self-expanding framework delivery device about a heart, comprising inserting the deployment tube into the thoracic cavity; deploying the self-expanding wire framework covered with a polymer film from the deployment aperture; bending outwardly of the self-expanding framework at the left midway bend and right midway to circumferential flare the lead edge of the articulated wire loops about the apex of the heart; and extending the self-expanding wire framework from the deployment aperture to encircle a portion of the heart.
Across the independent claims, the core inventive aspect is a polymer-covered self-expanding wire framework built from adjacent articulated wire loops with left and right midway bends, left/right struts to a hub with a fixed strut attachment point, and interlacing between adjacent loops, where the resulting tension produces circumferential outward flaring as deployment occurs from a deployment tube aperture.
Stated Advantages
Faster implantation.
Reduced guidewire entanglement and infection risk.
Shorter hospital stay.
Documented Applications
A minimally invasive extra-cardiac heart assist/cardiac compression device (DCCD) for heart failure support and/or diastolic support/compression and decompression, including embodiments with passive fluid chambers and active inflation chambers.
Implanting the device about a heart by inserting the deployment tube into the thoracic cavity and circumferentially flaring the lead edge about the apex of the heart, using the deployment aperture to extend the framework to encircle a portion of the heart.
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