Degradeable nasal ostial stent
Inventors
Spearman, Michael R. • Burban, John Henry • Shanahan, John William • Roberts, Keith A. • Catalano, Peter Joseph
Assignees
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Publication Number
US-10709585-B2
Publication Date
2020-07-14
Expiration Date
Abstract
A polymeric stent having a length, an outer surface and a cross-section. A lumen passes through the entire length, the lumen having a surface forming an equivalent diameter in the polymeric stent. The polymeric stent includes a first aqueous-swellable, biocompatible and biodegradable composition (e.g., polymer) having a thickness. The aqueous-swellable and biodegradable polymer retaining structural integrity for at least 1 hours up to thirty days when swollen to between 15% and 500% of its dry diameter and kept moist by a moist aqueous environment. Barrier layers of biodegradable polymer(s) may be used to prevent migration of liquids into the lumen.
Core Innovation
A degradable polymeric nasal ostial stent is described as a cylindrical polymeric tube having a through-lumen and an aqueous-swellable, biocompatible and biodegradable polymer layer. The polymeric stent retains structural integrity for at least one hour when swollen and kept moist by a moist aqueous environment, and the first diameter expands by at least 15% up to 500% when water is absorbed, as compared to the dry state.
The disclosed stent uses an aqueous-swellable biodegradable polymeric composition to secure open lumen patency in the ostium by swelling in a moist aqueous environment. Optional biodegradable polymer barrier layers are described as internal and/or external layers that prevent liquid migration into or out of the lumen, and their thickness can be less than 50% of the aqueous-swellable layer.
Degradation is described as occurring in human mucous by immersion, depending on the selected biodegradable polymer types. The aqueous-swellable biodegradable polymer is described as being selected from hydrolysable polymers and aqueous-dispersible or aqueous-soluble polymers, including cellulosic polymers, polyesters, polysaccharides, starch, sugars, and chitosan.
Claims Coverage
The independent claim is directed to a polymeric stent for insertion into nasal ostia with a layered cylindrical tube structure, an aqueous-swellable biodegradable polymer that retains structural integrity when swollen while kept moist, and a defined water-absorption-driven expansion of the first diameter. Multiple dependent claims refine the expansion range, add a degradation-time window in human mucous, constrain layered polymer compositions, and specify a less aqueous-swellable second layer and thickness ratio.
Cylindrical polymeric tube with continuous lumen surface
A polymeric tube having a first continuous outer surface with a first diameter and a continuous lumen passing through the entire length, the lumen having a continuous surface forming a continuous internal diameter of the cylindrical polymeric tube.
Aqueous-swellable, biocompatible and biodegradable polymer retaining integrity when swollen and moist
The polymeric tube comprises a first aqueous-swellable, biocompatible and biodegradable polymer having a thickness, wherein the first aqueous-swellable and biodegradable polymer retains structural integrity for at least one hour when swollen and kept moist by a moist aqueous environment.
Water absorption driven expansion of first diameter
The first diameter expands by at least 15% up to 500% when water is absorbed therein as compared to the first diameter of the polymeric stent in its dry state.
Less aqueous-swellable second biodegradable polymer layer with thickness ratio
A second biodegradable polymeric composition layer is on the internal diameter of the first biodegradable polymeric composition layer and is less aqueous-swellable, with thickness less than 50% of the first layer.
Polymer-type selection for aqueous-swellable biodegradable polymer layers
The first and second aqueous-swellable and biodegradable polymers are each independently selected from hydrolysable polymers, aqueous-dispersible polymers, or aqueous-soluble polymers.
Expansion range refinement for first diameter
The first diameter expands by at least 25% up to 500% when water is absorbed, compared to the dry-state diameter.
Degradation timing in human mucous
The first aqueous-swellable and biodegradable polymer degrades by immersion in human mucous within a period of from 1 to 30 days.
Overall claim coverage centers on a degradable polymeric nasal ostial stent as a cylindrical polymeric tube with a through-lumen and an aqueous-swellable, biocompatible, biodegradable polymer that retains structural integrity when swollen and kept moist, producing a defined water-absorption-driven expansion of the first diameter. Dependent claims further refine the expansion magnitude, add a degradation-time window in human mucous, and cover optional layered compositions with a less aqueous-swellable second layer and specified polymer-type categories.
Stated Advantages
Retains structural integrity for at least one hour when swollen and kept moist by a moist aqueous environment.
Expands by at least 15% up to 500% upon water absorption to secure open lumen patency in the ostium.
Barrier layers can prevent liquid migration into or out of the lumen.
Barrier layers allow tuning of solvent/solute transport and degradation.
Documented Applications
Insertion and use as a degradable polymeric nasal ostial stent to maintain open lumen patency in the ostium.
Degradation by immersion of the stent components in human mucous.
Figure-based stent variants including compressed foam with collapsed and swollen lumens, multi-lumen and blind-hole concepts, and conformal expansion to surrounding anatomy.
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