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the grip, a vascular graft, at least part of which is disposed coaxially about the mandrel, a sheath configured to be withdrawn proximally that constrains the vascular graft against the mandrel in an insertion diameter and an actuator that is moveable relative to the grip and engages the sheath assembly. A first operation of the actuator causing withdrawal of the sheath to free at least a distal portion of the vascular graft and a repeated operation of the actuator causing further withdrawal of the sheath to free a proximal portion of the vascular graft.

Core Innovation

The invention provides a method for implanting a vascular graft in a blood vessel of a patient using a vascular graft deployment tool. The tool includes a longitudinal axis, a grip, an elongated mandrel positioned distal of the grip, and a vascular graft with a distal portion and a proximal portion disposed coaxially about the mandrel. The graft is constrained against the mandrel in an insertion diameter by a sheath that is withdrawn proximally, and an actuator moveable relative to the grip engages the sheath assembly along a predetermined longitudinal range of motion.

The method positions at least a distal portion of the vascular graft within a lumen of the blood vessel and operates the actuator from an initial position to withdraw the sheath over a first range of motion to free only the distal portion. This allows expansion of the distal portion of the vascular graft from its constrained position by expanding from the insertion diameter. After the actuator returns to its initial position, the actuator is operated over the predetermined range again to further withdraw the sheath to free the proximal portion, allowing expansion of the proximal portion to secure the vascular graft to a branch graft.

A deployment architecture is disclosed in which the actuator performs first and second operations that correspond to freeing and expanding the distal portion and then the proximal portion. The deployment tool and related structures include a dilator tip on the mandrel, a needle with a lumen, and needle bleedback port structures that form a fluid flow path through the needle lumen and through a bleedback port in the dilator tip when the needle is in a distally extended position beyond the dilator tip. The tool may also include mechanisms for holding and retracting the needle so it does not protrude beyond the dilator tip, and may include a dilatation balloon disposed around the mandrel under the vascular graft, with vacuum deflation as an identified feature.

Claims Coverage

The document includes two independent claims, each centered on a two-stage release/expansion sequence implemented via a longitudinally movable actuator withdrawing a sheath. Across both independent claims, the core coverage is distributed across inventive features that constrain the graft against an elongated mandrel in an insertion diameter, free and expand the distal portion first, then free and expand the proximal portion to secure the graft to a branch graft.

Overall, the independent claims cover a vascular graft implantation approach and a corresponding deployment tool in which a sheath constrains a graft coaxially about an elongated mandrel, and a longitudinally movable actuator withdraws the sheath in two operations to sequentially free and expand the distal portion and then the proximal portion, including securing the vascular graft to a branch graft.

Stated Advantages

Documented Applications