Implantable scaffolds for treatment of sinusitus
Inventors
You, Changcheng • Pham, Quynh • Concagh, Danny
Assignees
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Publication Number
US-10806568-B2
Publication Date
2020-10-20
Expiration Date
Abstract
This disclosure describes various sinus scaffolds having fiber-based and non-fiber based designs, materials, devices, kits and methods that may be used to treat chronic sinusitis. These designs vary in form, dimension, and delivery location (i.e. maxillary, frontal, ethmoidal, sphenoidal sinuses, and middle meatus). In addition therapeutic agent(s) may optionally be included within the scaffolds for local delivery over a brief or extended period of time.
Core Innovation
The invention provides a scaffold for treatment of a human patient with rhinosinusitis, or a subject with a sinus condition, where the scaffold includes a layer comprising mometasone furoate and a biodegradable polymer material. The scaffold further includes a therapeutic-agent-free polymer topcoat layer positioned on the mometasone furoate/biodegradable polymer layer so as to control the release of the mometasone furoate.
The scaffold is delivered to the middle meatus under conditions where the scaffold conforms to the middle turbinate. In that conforming deployment state, the scaffold delivers mometasone furoate from the middle meatus to a sinus cavity of the human patient with chronic rhinosinusitis, or to a sinus cavity of the subject.
The disclosure is directed to chronic rhinosinusitis and sinusitis using implantable, self-expanding generally tubular sinus scaffolds that can include fibrous and non-fibrous scaffold forms and conform to sinus anatomy such as the middle turbinate for delivery to sinus cavities. The disclosure also describes scaffold/coating structures where biodegradable polymers and elastomer conformal coatings can be used.
An optional therapeutic-agent-free topcoat is used to regulate release, with scaffold deployment using radially constrained delivery concepts that support conforming placement and agent delivery into sinus cavities.
Claims Coverage
The independent claims cover three related methods involving a mometasone furoate-containing scaffold delivered to the middle meatus so it conforms to the middle turbinate and delivers to a sinus cavity, with a therapeutic-agent-free polymer topcoat in some claims. Two broader or parallel treatments include subject with a sinus condition language, and dependent refinements specify ethmoid sinus delivery and patient selection after failed medical management.
Therapeutic-agent-free polymer topcoat to control mometasone furoate release
providing a scaffold comprising a layer comprising mometasone furoate and a biodegradable polymer material and a therapeutic-agent-free polymer topcoat layer positioned on said layer so as to control the release of the mometasone furoate
Conforming scaffold delivery from the middle meatus to a sinus cavity
delivering said scaffold to the middle meatus under conditions where the scaffold conforms to the middle turbinate and delivers said mometasone furoate from the middle meatus to a sinus cavity
Mometasone furoate scaffold layer for sinus condition treatment
providing a scaffold comprising a layer comprising mometasone furoate and a polymer material
Ethmoid sinus targeting
delivering said mometasone furoate from the middle meatus to a sinus cavity of the subject, wherein the scaffold delivers said mometasone furoate to the ethmoid sinuses
Failed medical management patient selection after oral steroids
applying the method to a human patient who has failed medical management after receiving oral steroids
Failed medical management patient selection after topical steroids
applying the method to a human patient who has failed medical management after receiving topical steroids
The core inventive concept is a mometasone furoate-containing scaffold delivered to the middle meatus so it conforms to the middle turbinate and delivers mometasone furoate to a sinus cavity. Release control is tied to a therapeutic-agent-free polymer topcoat layer, and dependent refinements specify ethmoid sinus delivery and patient selection based on failure of medical management after oral or topical steroid administration.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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