Implantable scaffolds for treatment of sinusitis
Inventors
You, Changcheng • Pham, Quynh • Concagh, Danny
Assignees
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Publication Number
US-10864298-B2
Publication Date
2020-12-15
Expiration Date
Abstract
This disclosure describes, inter alia, materials, devices, kits and methods that may be used to treat chronic sinusitis. More specifically, a drug-eluting scaffold is implanted in the middle meatus to treat chronic sinusitis for weeks to months.
Core Innovation
The disclosed invention provides an implantable, self-expanding generally tubular sinus scaffold that is delivered into the middle meatus for treating chronic rhinosinusitis. The scaffold is an expandable multi-filament scaffold that self-expands and is configured to stabilize sinus openings/ostia and enable sustained local therapeutic-agent delivery in the middle meatus and other sinus cavities.
The scaffold is described as often fiber-based and generally braided, including multi-filament and multi-strand braids with variable braid angles and forms such as knitted, spiral-shaped, open-cylinder variants, and related geometries with nodes. The invention further describes conformal elastomeric coatings over the scaffold with patterned coated and uncoated regions and stiffness tuning, together with radiopaque additives.
The disclosed approach further states that delivering the scaffold improves sinus patency. Additional scaffold delivery and manufacturing aspects are described, including delivery systems such as catheters and expandable or balloon delivery, and coated-scaffold manufacturing approaches that include spray-coating and curing with diisocyanate crosslinking such as hexamethylene diisocyanate.
Claims Coverage
The independent claims cover three related treatment methods that share a common scaffold-release characterization. Across the independent claims, there are three inventive-feature groupings: delivery to the middle meatus in a human patient context, specification of mometasone furoate as the therapeutic agent with sinus patency improvement, and a per-unit scaffold area release characterization for the middle-meatus human method.
Middle meatus delivery with expandable multi-filament scaffold self-expansion and weekly quantified release
Delivering an expandable multi-filament scaffold comprising a therapeutic agent into the middle meatus of a human patient, where the expandable multi-filament scaffold self-expands and releases therapeutic agent such that weekly sampling after submersion in pH 7.4 PBS with 2 wt% SDS at 376 under gentle shaking on a rotary shaker, with complete weekly buffer replacement, yields 1% to 10% of the total amount originally in the scaffold from the second week through the twelfth week, or 0.05 to 4 g/mm2/week per unit scaffold area, or both.
Mometasone furoate scaffold delivery improving sinus patency with weekly quantified release
Delivering a self-expanding multi-filament scaffold comprising a therapeutic agent comprising mometasone furoate into the middle meatus of a subject, where the pH 7.4 PBS and 2 wt% SDS submersion test with complete weekly buffer replacement defines a therapeutic agent quantity released in each weekly sample from the second week through the twelfth week that ranges from 1% to 10% of the total originally in the scaffold, and wherein the scaffold delivered to the middle meatus improves sinus patency.
Therapeutic-agent release for at least 12 weeks with mometasone furoate and sinus patency improvement
Delivering a self-expanding multi-filament scaffold comprising a therapeutic agent comprising mometasone furoate into a subject, where the expandable scaffold releases the therapeutic agent for a period of at least 12 weeks, and where the pH 7.4 PBS and 2 wt% SDS submersion test with complete weekly buffer replacement defines a therapeutic agent quantity released in each weekly sample from the second week through the twelfth week that ranges from 1% to 10% of the total originally in the scaffold, and wherein the scaffold improves sinus patency.
Overall, the independent claims require delivery of a self-expanding expandable multi-filament therapeutic-agent scaffold using a defined weekly release quantification profile from week 2 to week 12. In the mometasone furoate variants, the claims expressly require improvement of sinus patency and, in one independent claim, release for at least 12 weeks.
Stated Advantages
Improves sinus patency.
Documented Applications
Treating chronic rhinosinusitis by delivering an implantable self-expanding sinus scaffold into the middle meatus of a human patient or subject.
In vivo characterization and deployment in rabbit sinuses, and deployment in human cadaver and swine nasal cavity contexts to observe scaffold deployment and release or mechanical behavior [procedural detail omitted for safety].
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