Implantable scaffolds for treatment of sinusitis
Inventors
You, Changcheng • Pham, Quynh • Concagh, Danny
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12564659-B2
Publication Date
2026-03-03
Expiration Date
Abstract
This disclosure describes, inter alia, materials, devices, kits and methods that may be used to treat chronic sinusitis. An implant is configured to fit inside of the middle meatus of a human nasal cavity. The implant includes a therapeutic-agent formulation containing a layer of over 2000 micrograms of mometasone furoate. The implant releases the mometasone furoate for more than 12 weeks. A second implant can also be provided configured to fit inside the middle meatus. The second implant also includes a therapeutic-agent formulation containing a layer of over 2000 micrograms of mometasone furoate, and releases the mometasone furoate for more than 12 weeks.
Core Innovation
The claimed method treats a sinus condition, such as chronic sinusitis, by implanting first and second implants into the middle meatuses of a patient. Each implant comprises at least one coating containing over 2000 micrograms of mometasone furoate configured on a self-expanding scaffold. The treated patient has no prior sinus surgery, has failed medical management based on oral or topical steroids, and is a candidate for sinus surgery based on a SNOT score.
The method measures symptom reduction and, after 24 weeks, determines that the patient is no longer a candidate for sinus surgery based on a SNOT score. The implants are subsequently removed, and further symptom reduction is evaluated one week post-removal. The disclosure demonstrates local, controlled, sustained delivery, including substantially linear or zero-order release from weeks 1 to 12, along with implant deployment and loading assemblies [procedural detail omitted for safety].
Claims Coverage
The claims identify one independent claim and several dependent claims covering five inventive features.
Bilateral middle meatus implant placement
Implanting first and second implants into the middle meatuses of a patient who has a sinus condition, no prior sinus surgery, has failed medical management based on oral and/or topical steroids, and is a candidate for sinus surgery based on a SNOT score. [procedural detail omitted for safety]
Mometasone furoate coating
Each implant comprises at least one coating containing over 2000 micrograms of mometasone furoate.
Symptom assessment and surgical candidacy determination
Measuring a reduction in one or more symptoms and determining after 24 weeks that the patient is no longer a candidate for sinus surgery based on a SNOT score. [procedural detail omitted for safety]
Implant removal and post-removal assessment
Removing the first and second implants and measuring a further reduction in symptoms one week post-removal based on a SNOT score.
Refined release profile and implantation timing
Dependent claims specify that the implants release 20 to 80% of the mometasone furoate during the first 12 weeks, exhibit zero-order release between 1 and 12 weeks after implantation, and are implanted prior to surgery.
The claims cover a sinus-condition treatment method utilizing bilateral mometasone-furoate-coated implants, symptom and surgical candidacy assessments, and implant removal with post-removal evaluation, with dependent claims defining drug release parameters and surgical timing.
Stated Advantages
The claimed method measures symptom reduction and determines that, after 24 weeks, the patient is no longer a candidate for sinus surgery based on a SNOT score, with reports that approximately 70% of patients are no longer candidates for surgery by three months.
The method measures a further reduction in symptoms one week after implant removal based on a SNOT score.
The scaffold provides local, controlled, sustained mometasone furoate delivery, with substantially linear release reported from weeks 1 to 12.
Documented Applications
Treatment of a sinus condition, including chronic sinusitis or chronic rhinosinusitis, in patients without prior sinus surgery who have failed medical management based on oral and/or topical steroids and are candidates for sinus surgery based on a SNOT score, using bilateral implants in the middle meatuses.
Sinus implant or scaffold configurations, endoscopic placement in the sinus, and implant deployment and loading assemblies.
Interested in licensing this patent?