Degradeable ostial stent

Inventors

Spearman, Michael R. • Burban, John Henry • Shanahan, John William • Roberts, Keith A. • Catalano, Peter Joseph

Assignees

Hemostasis LLC

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 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

The invention relates to a degradable polymeric stent for maintaining an open nasal ostium. The stent includes a cylindrical polymeric tube having a lumen passing through the entire length, where the lumen has a surface forming a diameter that is an internal diameter of the cylindrical polymeric tube. The cylindrical polymeric tube comprises a first aqueous-swellable, biocompatible and biodegradable polymer having a thickness.

The first aqueous-swellable, biocompatible and biodegradable polymer retains structural integrity for at least one hour when swollen and kept moist by a moist aqueous environment in a nasal passage in the ostium. Swelling of the polymer expands the cylindrical polymeric tube against tissue within the nasal ostium to secure the cylindrical polymeric tube within the nasal ostium. Natural fluids within the nasal ostium may be allowed to swell the polymer, or an artificial aqueous solution may be introduced to swell the polymer.

The described stent and method additionally include barrier layers of biodegradable polymer to prevent liquid or solvent migration into the lumen and to control transport. Barrier layers can be dense or intrinsically porous and can include an elastic and aqueous-swellable barrier layer, with additional layers optionally less aqueous-swellable than the first layer and thinner than the first layer. The disclosed embodiments include polymeric structures configured to expand, including shapes in which distal ends have greater diameters than a middle section and configurations with multiple lumens or blind holes for delivery of aqueous fluid into the lumen region.

Claims Coverage

The partial content provides two independent claims. The inventive features center on a cylindrical polymeric tube with a through-lumen, a first aqueous-swellable, biocompatible and biodegradable polymer that retains structural integrity when swollen in a moist aqueous environment, and swelling by natural fluids or an artificial aqueous solution to maintain an open nasal ostium.

Both independent claims require a polymeric stent having a cylindrical polymeric tube with a lumen through the entire length and a first aqueous-swellable, biocompatible and biodegradable polymer that retains structural integrity for at least one hour when swollen while kept moist by a moist aqueous environment. The swelling is achieved by natural fluids or an artificial aqueous solution to expand against tissue and maintain an open nasal ostium.

Stated Advantages

Documented Applications