Tool for placement of degradeable ostial stent
Inventors
Spearman, Michael J. • Burban, John H. • Catalano, Peter J. • Spearman, Brian M. • Roberts, Keith A. • Shanahan, John W.
Assignees
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Publication Number
US-11963896-B2
Publication Date
2024-04-23
Expiration Date
Abstract
A hand-held device is used to deliver and hydrate a temporary polymeric implant having a length, an outer surface and a cross-section, with a disruptable cover over the implant. A lumen may pass through the entire length, the lumen having a surface forming an equivalent diameter in the polymeric stent. The temporary polymeric implant 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 maintains an open nasal ostium in a mammal by inserting a polymeric medical implant comprising an aqueous swellable and biodegradable polymer into the nasal ostium. The medical implant includes a cylindrical polymeric tube or polymeric cylinder and an aqueous-removable protective cover over the outer surface, the cover comprising an aqueous soluble, aqueous dispersible, or aqueous degradable organic material and maintaining the dimensions of the cylindrical polymeric tube against forces of expansion until the protective cover loses mechanical strength.
Upon hydration, the aqueous-removable protective cover becomes disruptable and loses its mechanical strength, which allows the cylindrical polymeric tube to expand. The cylindrical polymeric tube expands by at least 15% when water is absorbed as compared to the first diameter in a dry state, and the swollen cylindrical polymeric tube remains in the mammalian nasal ostium for at least one hour after insertion while being swollen and kept moist.
After insertion and swelling, the guide shaft is removed without removing the cylindrical polymeric tube, leaving the swollen biodegradable polymeric tube in the nasal ostium. The polymeric tube biodegrades within the mammalian nasal ostium, while maintaining an open nasal ostium by expansion and in situ biodegradation following hydration-triggered disruption of the aqueous-removable protective cover.
Claims Coverage
The independent claims are directed to maintaining an open nasal ostium in a mammal using an aqueous swellable and biodegradable polymer implant with an aqueous-removable protective cover that preserves dimensions until hydration disrupts the cover, with subsequent expansion of the polymeric cylinder or tube by at least 15%. Two independent claims are present, each with multiple inventive features defining the implant structure, cover disruption mechanism, guide shaft support, and post-insertion conditions.
Aqueous-removable protective cover over aqueous swellable and biodegradable cylindrical tube
An aqueous-removable protective cover over the cylindrical polymeric tube, the cover comprising an aqueous soluble, aqueous dispersible, or aqueous degradable organic material, positioned over the outer surface such that when the protective cover loses its mechanical strength, the cylindrical polymeric tube expands.
Hydration-triggered disruption of the protective cover enabling expansion
Hydrating the aqueous-removable protective cover to disrupt the aqueous-removable protective cover and allow the cylindrical polymeric tube to expand, with the cover maintaining the dimensions of the polymeric medical implant against forces of expansion until subsequent to hydration.
Expansion of cylindrical polymeric tube by at least 15% with retention in nasal ostium and biodegradation
Removing the guide shaft without removing the cylindrical polymeric tube, wherein the first diameter expands by at least 15% when water is absorbed as compared to the first diameter of the cylindrical polymeric tube in a dry state, the swollen cylindrical polymeric tube remaining in the mammalian nasal ostium for at least one hour after insertion while swollen and kept moist, and the cylindrical polymeric tube biodegrading within the mammalian nasal ostium.
Guide shaft with distal end, lumen, and bent tip for insertion
Supporting the polymeric medical implant on a guide shaft having a distal end, a lumen and a bent tip; inserting the polymeric medical implant on the guide shaft into the mammalian nasal ostium while the guide shaft has a bent tip.
Guide shaft bent tip bent between 70 and 115 degrees and manual insertion
Supporting the polymeric nasal implant on a guide shaft having a distal end, a lumen, and a bent tip that is bent between 70 and 115 degrees; manually supporting the guide shaft; manually inserting the polymeric nasal implant into the mammalian nasal ostium using the guide shaft.
Hydration disrupts aqueous-removable protective cylinder to allow cylinder expansion
Hydrating the aqueous-removable protective cover in contact with and positioned over the outer surface of the polymeric cylinder to disrupt the aqueous-removable protective cover and allow the polymeric cylinder to expand, and hydrating the aqueous-removable polymeric cylinder implant to swell the cylindrical polymeric core.
Cylinder expansion by at least 15% after guide shaft removal without removing the polymeric cylinder
Removing the guide shaft without removing the polymeric cylinder, the first diameter expanding by at least 15% when water is absorbed in the polymeric cylinder as compared to the first diameter of the polymeric cylinder in a dry state.
Across the independent claims, maintaining an open nasal ostium is achieved by an aqueous swellable and biodegradable polymeric cylinder or tube kept dimensionally controlled by an aqueous-removable protective cover until hydration disrupts the cover. Hydration causes at least 15% diameter expansion, the guide shaft is removed without removing the polymeric implant, and the swollen implant remains in the nasal ostium while biodegrading within the ostium.
Stated Advantages
Maintains an open nasal ostium in a mammal by expanding a polymeric medical implant after hydration disrupts an aqueous-removable protective cover.
Maintains structural dimensions against forces of expansion until hydration disrupts the aqueous-removable protective cover.
Provides diameter expansion of at least 15% when water is absorbed compared to a dry state.
Keeps the swollen cylindrical polymeric tube in the mammalian nasal ostium for at least one hour after insertion while swollen and kept moist.
Allows biodegrading of the cylindrical polymeric tube within the mammalian nasal ostium.
Documented Applications
Maintaining an open nasal ostium in a mammal by inserting an aqueous swellable and biodegradable polymeric nasal implant with an aqueous-removable protective cover and hydrating to disrupt the cover and allow expansion.
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