Scaffold loading and delivery systems
Inventors
Helmick, Marc • Merlo, Jonathan • Core, Lee • Pham, Quyhn • Prostrollo, Anthony • Paulson, Ross • Peterson, Danielle • Prahl, Garrett • Beyreis, Randall • Chouinard, Michele
Assignees
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Publication Number
US-10857013-B2
Publication Date
2020-12-08
Expiration Date
Abstract
This disclosure describes, inter alia, materials, devices, kits and methods that may be used for loading scaffolds into delivery devices and delivery of scaffolds into the body of a patient, including delivery of scaffolds to the sinuses for the treatment of chronic sinusitis, among other purposes.
Core Innovation
The invention describes a delivery system for a self-expanding scaffold that is configured to be inserted into a proximal loading lumen end of a loading member and advanced through the loading lumen in a proximal-to-distal direction. The loading member includes a tapered loading lumen having a first diameter at the proximal loading lumen end and a second diameter smaller than the first diameter at the distal loading lumen end, and a delivery sheath having a delivery sheath lumen connected to the loading lumen.
The delivery system includes a second assembly having the self-expanding scaffold with a scaffold wall and a scaffold lumen, a proximal scaffold end and a distal scaffold end, an inner luminal surface, and an outer abluminal surface. The second assembly also includes an elongate advancement member with a proximal end and a distal end, at least one filament linking an end of the elongate advancement member to the scaffold, and an elongate inner member with a proximal end and a distal end.
From the background, the invention addresses chronic rhinosinusitis and the need for localized drug/stent delivery in sinonasal anatomy such as sinus ostia and during functional endoscopic sinus surgery (FESS). The document further describes scaffold loading and delivery mechanisms for self-expanding braided/spiral scaffolds into a delivery catheter or delivery sheath, including distal deployment/navigation via curved or shape-memorized sheaths and deployment strategies using balloon-assisted release and anchoring balloons.
Claims Coverage
The independent claim set covers a delivery system including a first assembly with a tapered loading lumen and delivery sheath connected thereto, and a second assembly with a self-expanding scaffold, an elongate advancement member, at least one filament linking the advancement member to the scaffold, and an elongate inner member configured for insertion and proximal-to-distal advancement through the first assembly. Dependent claims refine the inventive mechanical features of loading-member form, force application to the advancement member, filament routing/attachment patterns, and advancement-member structures for filament retention and severing.
Tapered loading lumen delivery interface
A loading member comprises a tapered loading lumen having a proximal loading lumen end and a distal loading lumen end, wherein the proximal loading lumen end has a first diameter and the distal loading lumen end has a second diameter smaller than the first diameter, and a delivery sheath having a delivery sheath lumen is connected to the loading lumen.
Self-expanding scaffold assembly for lumen advancement
A self-expanding scaffold has a scaffold wall and a scaffold lumen, a proximal scaffold end and a distal scaffold end, an inner luminal surface, and an outer abluminal surface, and is configured to move through the loading lumen in a proximal-to-distal direction.
Elongate advancement member linked to the scaffold by filaments
An elongate advancement member has a proximal end and a distal end, and at least one filament links an end of the elongate advancement member to the scaffold, wherein the second assembly is configured to be inserted into the proximal loading lumen end of the loading member and advanced at least partially through the first assembly.
Elongate inner member to support insertion and advancement
An elongate inner member has a proximal end and a distal end, wherein the second assembly includes the elongate inner member in addition to the elongate advancement member and filament linkage, and the second assembly is configured to be advanced through the first assembly such that the scaffold is moved through the loading lumen.
Detachable or integrated funnel-style loading member
The loading member is formed as a detachable funnel or as an integrated funnel-and-handle single article.
Force application to advance the advancement member
The second assembly is advanced at least partially through the first assembly by applying force to either end of the elongate advancement member.
Filament loop routing through a scaffold wall aperture
At least one filament is looped from the elongate advancement member through an aperture in a scaffold wall and back to the elongate advancement member.
Groove-based filament retention and cut-and-sever
The elongate advancement member includes a groove that holds one end of the at least one filament so the end can be cut and severed from the member.
Two-portion advancement member trapping a filament end
At least one filament has one end attached to one of two portions and its opposite end trapped between the two portions.
Overall, the claims define a scaffold delivery system in which a self-expanding scaffold is coupled to an elongate advancement member via filaments and inserted into a tapered loading lumen connected to a delivery sheath, with an elongate inner member supporting advancement in a proximal-to-distal direction. Dependent claim features specify particular loading-member configurations, how force is applied, filament routing/attachment patterns, and advancement-member structures that support retention, looping, and severing of filament ends.
Stated Advantages
Controlled, uniform crimping.
Precise placement of the scaffold.
Combined pull/push deployment.
Documented Applications
Localized drug/stent delivery in sinus spaces during functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis.
Deployment and conformance testing of multiple scaffold prototypes with multiple catheter sizes in a cadaver study showing deployability and conformance in sinus spaces.
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