Device and methods for treating paranasal sinus conditions
Inventors
Eaton, Donald J. • Tice, Thomas R. • Downie, David B. • Arensdorf, Patrick A. • Brenneman, Rodney A. • Clay, Danielle L.
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11123091-B2
Publication Date
2021-09-21
Expiration Date
Abstract
Described here are paranasal sinus devices for treating paranasal sinus conditions. The devices include a cavity member, ostial member, and nasal portion. One or more of the cavity member, ostial member, and nasal portion may deliver an active agent for sustained release to treat the paranasal sinus condition. Exemplary paranasal sinus conditions are sinus inflammation due to functional endoscopic sinus surgery (FESS) and rhinosinusitis.
Core Innovation
The invention relates to paranasal sinus drug-delivery devices that include an expandable cavity member configured to be deployed into a sinus ostium or fenestration to provide sustained local release. The devices incorporate an expandable cavity member with a proximal end and a distal end, sized and shaped to fit within a paranasal sinus cavity, and an expandable pronged structure. The expandable cavity member is bioabsorbable and self-expanding, and includes prongs that flex radially outward to contact sinus mucosa.
In one described configuration, the expandable cavity member comprises three or more pliable partially curved filaments, each having a proximal end and a distal end with free distal ends or free distal tips that define the distal end of the cavity member. The described embodiments include self-expanding pronged filament or fringe structures that substantially contact sinus mucosa, including variations with anchoring elements such as hooks, spikes, barbs, or ridges and optionally radiopaque markers. The nasal portion positions and anchors at the ostium and is described as reducing turbinate lateralization and adhesions.
The expandable cavity member and/or associated polymer matrices can be used to incorporate an active agent for sustained local release at the target site. Active agents are described as being incorporated in biodegradable or nonbiodegradable polymer matrices, including polymer examples such as PLGA (poly(lactide-co-glycolide)) and lactide/glycolide polymers, and can be coated or encapsulated. Example active agents explicitly described include steroid agents such as mometasone furoate and fluticasone propionate, with release-kinetics concepts discussed using polymer and mucoadhesive materials.
Claims Coverage
The partial set includes two independent claims (clm-00001 and clm-00009) and their associated dependent refinements. Across the independent claims, the main inventive features are a bioabsorbable, self-expanding expandable cavity member formed by pliable, partially curved prongs/filaments that radially expand to contact sinus mucosa, with filaments having a specified length and distal free ends/tips that define the distal end of the cavity member.
Bioabsorbable self-expanding pronged expandable cavity member sized for paranasal sinus
A bioabsorbable expandable cavity member having a proximal end and a distal end, sized and shaped to fit within a paranasal sinus cavity, wherein the expandable cavity member comprises a pronged structure and is self-expanding.
Pliable partially curved filaments flexing radially outward to contact sinus mucosa
A pronged structure comprising three or more filaments that are pliable and partially curved, wherein the filaments flex radially outwardly to contact sinus mucosa.
Specified filament length and free distal ends/tips defining the distal end
Each filament having a length between about 2 cm and about 5 cm, a proximal end, and a distal end, wherein the distal ends are free distal ends (or free distal tip), and wherein the free distal ends or free distal tips define the distal end of the cavity member.
Both independent claims converge on a bioabsorbable, self-expanding expandable cavity member for a paranasal sinus cavity, where pliable partially curved filaments flex radially outward to contact sinus mucosa. The claims further specify a filament length range (about 2 cm to about 5 cm) and free distal ends or free distal tips that define the distal end of the cavity member.
Stated Advantages
Sustained local release at a target site within a paranasal sinus ostium/fenestration.
Reduces turbinate lateralization and adhesions.
Documented Applications
Drug delivery to a paranasal sinus ostium/fenestration with sustained local release, described in relation to conditions including rhinosinusitis.
Use of sinus insertion and deployment through an inserter/sheath and expansion concepts for placement in the sinus.
Evaluation using in vivo rabbit sinus tissue mometasone quantification and in vitro cumulative release over time.
Interested in licensing this patent?