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Publication Number
US-12064577-B2
Publication Date
2024-08-20
Expiration Date
Abstract
Described here are devices, systems, and methods for treating conditions or diseases of the nose, ear, or throat with an expandable device having a drug coating. The expandable devices may be delivered to a body cavity in a low-profile configuration and expanded to contact surrounding tissue. The expandable devices may deliver or release the drug coating to the tissue. Multiple expansions of a single device may be employed during treatment. Various coating excipients and manufacturing parameters for the expandable devices may also be adjusted to enhance or slow transfer of the drug coating and/or release of the drug to the target tissue site. The drug transferred to the tissue may act as an in situ depot that enables maintenance of a therapeutic level of locally delivered drug for a desired time period after removal of the expandable devices.
Core Innovation
The invention relates to an expandable device having a low-profile configuration and an expanded configuration, with an external surface that is brought into contact with tissue after expansion. A drug coating is applied to the external surface so that the drug coating is transferred in connection with the expansion and contact with the tissue, and the drug coating comprises a mixture of crystalline and amorphous forms of a drug.
The external surface of the expandable device is primed prior to applying the drug coating, using a hydrophilic excipient, a hydrophobic excipient, an amphiphilic excipient, a lipophilic excipient, or a combination thereof. The drug coating comprises at least one pharmacologically active agent selected from a list that includes local anesthetic, painkiller, vasoconstrictor, antiseptic, antioxidant, anti-inflammatory agent, anti-allergen agent, antibacterial agent, anti-cholinergic agent, antihistamine, anti-infective agent, anti-platelet agent, anti-coagulant, anti-thrombotic agent, anti-scarring agent, anti-proliferative agent, chemotherapeutic agent, anti-neoplastic agent, decongestant, healing promoting agent, vitamin, hypersomolar agent, immunomodulator, immunosuppressive agent, and adjunct agents including penetration enhancer, mucoadhesive, mucolytic, or combinations thereof.
The device is described in connection with directional expansion into nasal, otic, and throat tissue sites, including sinuses and the Eustachian tube, as well as the ear canal and throat regions. In expanded use, the directional expansion contacts a portion of the expanded device surface area with the tissue site, and the transferred drug coating can act as an in situ sustained-release depot after removal of the expandable device.
Claims Coverage
The partial content includes two independent claims. Both independent claims cover an expandable device in a low-profile configuration and an expanded configuration with an external surface, where the external surface is primed with excipients and coated with a drug coating containing a mixture of crystalline and amorphous drug forms. Across the independent claims, the inventive coverage differs mainly by whether the claim requires the drug coating to include a specified set of pharmacologic agent categories.
Low-profile expandable device with external surface drug coating of crystalline/amorphous mixture
A method providing an expandable device having a low-profile configuration, an expanded configuration, and an external surface; priming the external surface with a hydrophilic excipient, a hydrophobic excipient, an amphiphilic excipient, a lipophilic excipient, or a combination thereof; and applying a drug coating to the external surface, where the drug coating comprises a mixture of crystalline and amorphous forms of a drug.
Primed external surface and crystalline/amorphous drug coating
A method providing an expandable device having a low-profile configuration, an expanded configuration, and an external surface; priming the external surface of the expandable device with an excipient comprising a hydrophilic excipient, a hydrophobic excipient, an amphiphilic excipient, a lipophilic excipient, or a combination thereof; and applying a drug coating to the external surface, where the drug coating comprises a mixture of crystalline and amorphous forms of a drug.
Overall claim coverage in the partial content centers on priming the external surface of a low-profile expandable device with defined excipient classes and applying a drug coating that includes both crystalline and amorphous drug forms. One independent claim additionally limits the drug coating to include at least one drug selected from a broad list of pharmacologic agent categories and adjunct agents including penetration enhancers and mucoadhesives/mucolytics.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treating nasal conditions including rhinosinusitis, rhinitis, and allergic rhinitis.
Treatment involving sinus ostium and tissue contact regions including inferior turbinate and the Eustachian tube.
Treating otic conditions including otitis media.
Treating throat conditions.
The drug coating can act as an in situ sustained-release depot after removal of the expandable device.
Supporting directional expansion such that the expanded device surface contacts a tissue site and transfers a drug coating to the tissue site.
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