Vascular and aortic grafts and deployment tools

Inventors

Palermo, Thomas J. • Lee, Pin-Hsuan • Jen, Jimmy

Assignees

Aquedeon Medical Inc

Abstract

A vascular graft deployment tool may include a grip, an elongated mandrel positioned distal of the grip, a vascular graft, at least part of which is disposed coaxially about the mandrel, a sheath assembly including a distal sheath portion and a proximal sheath potion, wherein the distal sheath portion and the proximal sheath portion are configured to constrain the vascular graft against the mandrel in an insertion diameter and a actuator that is moveable relative to the grip and engages the sheath assembly, wherein operation of the actuator causes at least one of the distal sheath portion and the proximal sheath portion to separate longitudinally to free at least a portion of the vascular graft. Further, a vascular graft is expandable from an insertion state to a deployed state and at least two suture cuffs are located between opposed ends of the vascular graft.

Core Innovation

The invention relates to a vascular graft deployment tool for deploying a vascular graft, including an aortic graft, using an elongated mandrel and a sheath assembly that constrains the vascular graft to an insertion diameter. The tool includes a grip with the elongated mandrel positioned distal of the grip, and at least part of the vascular graft disposed coaxially about the mandrel. A distal sheath portion and a proximal sheath portion are connected by a center section comprising at least two ribbons, so the sheath assembly constrains the vascular graft against the mandrel within the insertion diameter.

An actuator is moveable relative to the grip and engages the at least two ribbons of the sheath assembly. Operation of the actuator causes at least one of the distal sheath portion and the proximal sheath portion to separate longitudinally to free at least a portion of the vascular graft from the constrained state. The document describes additional embodiments in which the sheath splitting and release are implemented via specific actuator interfaces and interactions, including rollers/pegs or tabs/ribs, to engage and separate the ribbons along the longitudinal direction.

The deployment system is further described with subsystems supporting graft delivery and monitoring, including a dilator tip with a slidable needle and a guidewire, a needle retraction assembly, and bleedback ports for visual blood-flow indication. The document also describes optional use of a dilatation balloon associated with the mandrel, including inflation followed by vacuum deflation. For vascular graft construction, the described grafts include expandable hoop/stent anchors and self-expanding expandable mesh ends, and at least two suture cuffs, and the document further describes aortic graft configurations such as a central section with jumper grafts/manifold and an access port with a hemostasis valve.

Claims Coverage

The patent includes two independent claims: a vascular graft deployment tool claim and a method of implanting a vascular graft claim. Across these independent claims, the main inventive structure centers on an elongated mandrel with a coaxial graft, a ribbon-connected sheath assembly that constrains the graft to an insertion diameter, and an actuator that separates sheath portions longitudinally by engaging the ribbons, followed by securing by expansion.

In summary, the tool claim is directed to a grip/elongated mandrel coaxial vascular graft arrangement combined with a ribbon-connected sheath assembly that constrains the graft in an insertion diameter and an actuator that engages the ribbons to cause longitudinal sheath separation to free the graft. The method claim tracks the same structural tool elements for implanting in a patient's blood vessel, with graft release by actuator-driven longitudinal sheath separation and securing by expansion from the insertion diameter.

Stated Advantages

Documented Applications

No documented applications found