# US 10,441,757 B2 · Drug-coated balloon > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,441,757 B2 - Document ID: US10441757B2 - Status: Granted - Kind: B2 - Application number: 15/004,807 - Filed: 2016-01-22 - Published: 2016-07-28 - Granted: 2019-10-15 - Earliest claimed: 2015-01-22 - Assignees: Intersect ENT, Inc. - Applicants: Intersect ENT, Inc. - Inventors: Richard E. Kaufman; John Joseph Stankus; James Su - Web page: https://patentgrep.com/patent/US10441757B2 ## CPC - A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00}) - A61L 29/085: {Macromolecular materials} - A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)} - A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)} - A61L 2300/222: Steroids, e.g. corticosteroids - A61L 2300/41: Anti-inflammatory agents, e.g. NSAIDs - A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes} - A61M 2210/065: Throat; Pharynx - A61M 2210/0662: Ears - A61M 2210/0668: Middle ear - A61M 2210/0675: Eustachian tube - A61M 2210/0681: Sinus (maxillaris) - A61M 2210/105: Oesophagus - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) ## 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. ## Claims ### Claim 1 A method of treating a nasal, otic, or throat condition, comprising: providing an expandable device comprising a drug coating on an external surface thereof and having a low-profile configuration and an expanded configuration; delivering the expandable device in the low-profile configuration to a target tissue site; transferring the drug coating from the external surface to the target tissue site over multiple expansions of the expandable device, wherein transfer of the drug coating is controlled during each expansion; removing the expandable member from the target tissue site; and maintaining a therapeutic level of local drug delivery at the target tissue site from the transferred drug coating for a time period effective to treat the target tissue site. ### Claim 2 (depends on 1) The method of claim 1, wherein the expandable device is expanded at multiple target tissue sites. ### Claim 3 (depends on 1) The method of claim 1, wherein the nasal condition is selected from the group consisting of post-surgical inflammation, turbinate hypertrophy, rhinosinusitis, and rhinitis. ### Claim 4 (depends on 1) The method of claim 1, wherein the target tissue site is a paranasal sinus, a sinus ostium, an inferior turbinate, a middle turbinate, a superior turbinate, a nasal cavity, the osteomeatal complex, the nasopharynx, adenoid tissue, or a combination thereof. ### Claim 5 (depends on 4) The method of claim 4, wherein the paranasal sinus is a maxillary sinus, a frontal sinus, an ethmoidal sinus, or a sphenoidal sinus. ### Claim 6 (depends on 1) The method of claim 1, wherein the otitis condition is selected from the group consisting of post-surgical inflammation, otitis media, Meniere's disease, Eustachian tube dysfunction, and tinnitus. ### Claim 7 (depends on 6) The method of claim 6, wherein the target tissue site is the Eustachian tube, external ear canal, or middle ear. ### Claim 8 (depends on 1) The method of claim 1, wherein the throat condition is selected from the group consisting of post-surgical pain, esophageal cancer, airway stenosis, chronic laryngitis, tonsillitis, and epiglottitis. ### Claim 9 (depends on 1) The method of claim 1, wherein the expandable device is compliant. ### Claim 10 (depends on 9) The method of claim 9, wherein the expandable device distends upon inflation to the expanded configuration. ### Claim 11 (depends on 1) The method of claim 1, wherein the expandable device is semi-compliant. ### Claim 12 (depends on 1) The method of claim 1, wherein the expandable device is non-compliant. ### Claim 13 (depends on 12) The method of claim 12, wherein the expandable device is folded, pleated, or wrapped in the low-profile configuration. ### Claim 14 (depends on 1) The method of claim 1, wherein the expandable device is an inflatable balloon. ### Claim 15 (depends on 14) The method of claim 14, wherein the inflatable balloon has an inflation pressure between about 2 atm and 16 atm. ### Claim 16 (depends on 15) The method of claim 15, wherein the inflation pressure is between about 10 atm and 12 atm. ### Claim 17 (depends on 15) The method of claim 15, wherein the inflation pressure is between about 4 atm and 16 atm. ### Claim 18 (depends on 1) The method of claim 1, wherein the drug coating comprises a lipophilic drug. ### Claim 19 (depends on 1) The method of claim 1, wherein the drug coating comprises a corticosteroid. ### Claim 20 (depends on 19) The method of claim 19, wherein the corticosteroid comprises mometasone furoate. ### Claim 21 (depends on 1) The method of claim 1, wherein transfer of the drug coating from the expandable device to the target tissue site occurs within about 5 seconds to about 2 hours. ### Claim 22 (depends on 21) The method of claim 21, wherein transfer of the drug coating from the expandable device to the target tissue site occurs within about 10 minutes to about 30 minutes. ### Claim 23 (depends on 21) The method of claim 21, wherein transfer of the drug coating from the expandable device to the target tissue site occurs within about 5 seconds to about 5 minutes. ### Claim 24 (depends on 1) The method of claim 1, wherein the time period effective to treat the target tissue site is between 5 days and 90 days. ### Claim 25 (depends on 1) The method of claim 1, wherein the time period effective to treat the target tissue site is from about 2 months to about 3 months. ### Claim 26 (depends on 1) The method of claim 1, wherein the drug coating comprises a drug and one or more excipients. ### Claim 27 (depends on 26) The method of claim 26, wherein the drug coating comprises a drug to excipient ratio ranging from 3:1 to 1:3. ### Claim 28 (depends on 27) The method of claim 27, wherein the drug coating comprises a drug to excipient ratio of 2:1. ### Claim 29 (depends on 27) The method of claim 27, wherein the drug coating comprises a drug to excipient ratio of 1:1. ### Claim 30 (depends on 27) The method of claim 27, wherein the drug coating comprises a drug to excipient ratio of 1:2. ### Claim 31 (depends on 27) The method of claim 27, wherein the drug coating comprises a drug to excipient ratio of 1:3. ### Claim 32 (depends on 27) The method of claim 27, wherein the drug coating comprises a drug to excipient ratio of 3:1. ### Claim 33 (depends on 26) The method of claim 26, wherein the drug comprises mometasone furoate or pharmaceutically acceptable salts, solvates, hydrates, esters, free base, enantiomers, racemates, polymorphs, amorphous, or crystal forms thereof. ### Claim 34 (depends on 26) The method of claim 26, wherein the excipient comprises poly(vinyl pyrrolidone), a polysorbate, a poly(ethylene glycol), or a combination thereof. ### Claim 35 (depends on 26) The method of claim 26, wherein the drug comprises mometasone furoate and the excipient comprises poly(vinyl pyrrolidone). ### Claim 36 (depends on 26) The method of claim 26, wherein the drug comprises mometasone furoate and the excipient comprises a polysorbate. ### Claim 37 (depends on 26) The method of claim 26, wherein transfer of the drug coating delivers about 0.5 mg to about 3 mg of the drug to the target tissue site. ### Claim 38 (depends on 26) The method of claim 26, wherein transfer of the drug coating delivers about 0.5 mg to about 1.5 mg of the drug to the target tissue site. ### Claim 39 (depends on 26) The method of claim 26, wherein the drug in the drug coating has a dose density ranging from about 100 μg/cm2 to about 600 μg/cm2. ### Claim 40 (depends on 26) The method of claim 26, wherein prior to expanding, less than about 10% of the drug is lost from the drug coating. ### Claim 41 (depends on 26) The method of claim 26, wherein after expanding, greater than about 80% of the drug is transferred from the drug coating to the target tissue site. ### Claim 42 (depends on 1) The method of claim 1, wherein drug coating comprises at least one of a poly(ethylene glycol), poly(vinyl pyrrolidone), phospholipids, fatty acids, sodium dodecyl sulfate, polysorbates, poloxamers, hydroxypropyl-beta-cyclodextrin, and sucrose fatty acid monoester. ### Claim 43 (depends on 1) The method of claim 1, wherein the drug coating comprises at least one of a low molecular weight poly(ethylene glycol), glycerol, polysorbates, fatty acids, sebacates, fatty alcohols, lipids, lecithin, oils, vegetable oils, glycol esters, and propylene glycol. ### Claim 44 (depends on 1) The method of claim 1, wherein the drug coating comprises at least one of a chitosan, collagen, elastin, silk, silk-elastin, alginate, cellulose, dextran, polyalkoanates, hyaluronic acid, gelatin, and gellan, polylactide, poly(lactide-co-glycolide), poly(L- lactide-co-ε-caprolactone), polyglycolide, polyhydroxybutyrate, polyhydroxyvalerate, poly(ethylene glycol), polydioxanone, polyglactin, poly(ε-caprolactone), polyglyconate, poly(glycolide-co-trimethylene carbonate), poly(sebacic acid), poly(ester urethane), poly(ester urethane) urea, cross-linked PEG, polyNIPAAM, PEG-PLA block copolymers, and poloxamers. ### Claim 45 (depends on 1) The method of claim 1, further comprising collapsing the expandable device to the low-profile configuration. ### Claim 46 (depends on 1) The method of claim 1, wherein the throat condition is tracheal stenosis, subglottic stenosis, or esophageal stenosis. ### Claim 47 (depends on 1) The method of claim 1, wherein each expansion of the multiple expansions of the expandable device is less than 30 seconds.