Scaffold loading and delivery systems
Inventors
Merlo, Jon • Core, Lee • Prahl, Garrett • White, Travis • Goh, Bryan • Beyreis, Randy
Assignees
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Abstract
This disclosure pertains, inter alia, to scaffold loading and delivery devices, assemblies, systems and methods of using the same.
Core Innovation
The document describes scaffold delivery for a self-expanding tubular implant with a delivery catheter and a tapered loading member. The tapered loading member includes a loading lumen and is configured with a funnel assembly and a slotted wall. A scaffold is disposed within the loading lumen around an elongate inner member, and the tapered loading member defines a tapered region configured to reduce scaffold diameter as the scaffold is advanced toward the delivery lumen.
A loading aid assembly is described that includes at least one loading pin engaged with the scaffold and configured to move longitudinally so that the scaffold also moves longitudinally toward the delivery sheath. The loading pins extend through the scaffold and into the elongate inner member, and longitudinal movement of the loading pins also moves the elongate member toward the delivery lumen. In some embodiments, the tapered loading member includes longitudinal slots that guide pin movement through the loading lumen.
The document further describes optional loading pin engagement features and component interactions, including a receptacle and pin springs biasing pins toward a receptacle axis, as well as a loading stop limiting pin travel. A pin lift can radially retract the pins to release them from the scaffold and from slots. In some embodiments, further longitudinal movement closes funnel slots and draws the scaffold into an outer sheath, and a scaffold lock retains the scaffold for proximal-to-distal controlled deployment and crimping just prior to implantation to avoid stress relaxation during shipping or storage.
Claims Coverage
The document provides coverage for two independent claims: a scaffold delivery method and a delivery assembly. Across the independent claims, the key inventive features are the tapered loading member with a loading lumen, the use of loading pins that extend through the scaffold into an elongate inner member, and the communication between the loading lumen and a delivery lumen in the delivery sheath.
Tapered loading member with loading lumen and delivery lumen communication
A delivery system includes an elongate member and a tapered loading member comprising a loading lumen, wherein a delivery sheath comprises a delivery lumen in communication with the loading lumen.
Longitudinally moving loading pins extending through scaffold into elongate inner member
At least one loading pin engaged with the scaffold extends through the scaffold and into the elongate inner member, and moving the at least one loading pin longitudinally towards the delivery sheath moves the scaffold longitudinally and also moves the elongate member towards the delivery lumen.
Self-expanding scaffold disposed around elongate inner member within loading lumen
The delivery assembly includes a self-expanding scaffold disposed around the elongate inner member within the loading lumen of the tapered loading member.
Optional slot-guided pin movement within tapered loading member
The tapered loading member includes slots, and movement of the at least one loading pin occurs within those slots.
Loading pin engagement member and optional ring-shaped configuration
The delivery system includes a loading pin engagement member for engagement with one or more loading pins, wherein in some embodiments the loading pin engagement member is a ring-shaped member.
Overall, the claims cover delivery using a tapered loading member with a loading lumen that communicates with a delivery sheath lumen, together with loading pins that move longitudinally to drive both the scaffold and an elongate inner member toward the delivery lumen. Dependent features further specify slot-constrained pin movement and add a loading pin engagement member, optionally ring-shaped.
Stated Advantages
Supports proximal-to-distal controlled deployment.
Crimping just prior to implantation to avoid stress relaxation during shipping/storage.
Documented Applications
Delivery of a self-expanding tubular implant (scaffold/stent) using a delivery catheter for controlled deployment and crimping just prior to implantation.
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