Tool for placement of degradable ostial stent
Inventors
Spearman, Michael J. • Burban, John H. • Catalano, Peter J. • Spearman, Brian M. • Roberts, Keith A. • Shanahan, John W.
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11752020-B2
Publication Date
2023-09-12
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 sinus ostium in a mammal using a temporary nasal ostial implant comprising an aqueous swellable and biodegradable polymer. The temporary medical implant includes an aqueous-removable protective cover and a cylindrical polymeric tube with a first diameter, where the protective cover is in contact with and positioned over the outer surface of the cylindrical polymeric tube.
The aqueous-removable protective cover maintains the dimensions of the nasal ostial implant against forces of expansion, while being biocompatible and disruptable by hydration. Hydrating the implant disrupts the protective cover and allows the nasal ostial implant to expand, and the first diameter expands by at least 15% when water is absorbed therein compared to the first diameter of the polymeric tube in a dry state.
After swelling, the aqueous-swellable and biodegradable polymer remains in the mammalian ostium for at least one hour after insertion, after being swollen and kept moist by a moist aqueous environment within the mammalian ostium. The method maintains the open sinus ostium through biodegrading the nasal ostial implant after insertion.
The nasal ostial implant is attached to a tool comprising a guide shaft having a lumen and a bent tip, where the guide shaft supports the nasal ostial implant extending from, adjacent to or along the distal end of the guide shaft. Using the guide shaft, the method inserts the nasal ostial implant into the mammalian ostium, hydrates to disrupt the aqueous-removable protective cover, and then removes the guide shaft without removing the implant.
Claims Coverage
The partial content contains four independent claims, all directed to methods of maintaining an open sinus ostium using an aqueous-swellable and biodegradable polymer nasal ostial implant with an aqueous-removable protective cover and guided insertion followed by hydration-triggered expansion, retention, and biodegradation. The inventive features are centered on the constrained-to-expand implant structure, hydration-triggered disruption and expansion performance, and guide-shaft delivery including a bent tip and lumen support.
Hydration-disruptable protective cover over cylindrical polymeric tube
Using a nasal ostial implant comprising an aqueous-removable protective cover in contact with and positioned over an outer surface of a cylindrical polymeric tube, where the aqueous-removable protective cover maintains dimensions against forces of expansion and is biocompatible and disruptable by hydration.
Hydration-triggered diameter expansion by at least 15%
Hydrating the aqueous-removable protective cover to disrupt it and allow the nasal ostial implant to expand, and hydrating the implant to swell such that the first diameter expands by at least 15% when water is absorbed therein compared to a first diameter of the polymeric tube in a dry state.
Retention at least one hour while swollen and kept moist, followed by biodegradation
Leaving the aqueous-swellable and biodegradable polymer remaining in the mammalian ostium for at least one hour after insertion after being swollen and kept moist by a moist aqueous environment within the mammalian ostium, and allowing the nasal ostial implant to biodegrade.
Guide shaft with lumen and bent tip supports nasal ostial implant for insertion and removal
Attaching the nasal ostial implant to a tool comprising a guide shaft having a lumen and a bent tip, where the guide shaft supports the nasal ostial implant extending from, adjacent to or along the distal end of the guide shaft, using the guide shaft to insert into the mammalian ostium, hydrating to disrupt the aqueous-removable protective cover, and removing the guide shaft without removing the implant.
Across the independent claims, the core inventive coverage is the nasal ostial implant that is constrained by an aqueous-removable protective cover over a cylindrical aqueous-swellable and biodegradable polymer tube, which is disrupted by hydration to enable expansion, while the swollen polymer remains for at least one hour when kept moist and then biodegrades, delivered via a lumen-bearing guide shaft with a bent tip that supports the implant for insertion and guide-shaft removal without removing the implant.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Maintaining an open sinus ostium in a mammal using a temporary nasal ostial implant.
Maintaining an open sinus ostium in a mammal using a polymeric medical implant in a method comprising insertion into a mammalian ostium followed by hydration, retention, and biodegradation.
Interested in licensing this patent?