Devices and methods for delivering active agents to the osteomeatal complex

{
  "publication_number": "US2009017090A1",
  "country": "US",
  "kind": "A1",
  "title": "Devices and methods for delivering active agents to the osteomeatal complex",
  "abstract": "Described here are devices, methods, and kits for treating sinusitis and related respiratory conditions by locally delivering active agents to the osteomeatal complex over a sustained period of time. The devices may be passively fixed within the osteomeatal complex and/or include one or more features that actively fix it within the osteomeatal complex. The devices may optionally include a portion that extends into a sinus ostium, sinus cavity, and/or the nasal passage to deliver an active agent.",
  "claims": [
    "1. An implantable sustained drug delivery device for treating sinusitis and related respiratory conditions comprising a therapeutically effective amount of an active agent, wherein the device delivers the active agent for local sustained release to the osteomeatal complex.",
    "2. The device of claim 1 wherein the related respiratory condition is selected from the group consisting of inflammation of the osteomeatal complex, osteomeatal complex or sinus cavity inflammation due to surgery; sinusitis; rhinitis; rhinosinusitis; upper respiratory tract infections; otitis media; bronchitis; bronchiolitis; asthma; tonsillitis and other chronic diseases of the tonsils and adenoids; laryngitis; tracheitis; nasal and sinus polyposis; neoplasms of the large and small airways; and nasal, sinus, or nasopharynx tumors.",
    "3. The device of claim 1 wherein the respiratory condition is inflammation of the osteomeatal complex.",
    "4. The device of claim 1 wherein the related respiratory condition is nasal or sinus polyposis.",
    "5. The device of claim 1 wherein the active agent is selected from the group consisting of anticholinergic agents, antihistamines, anti-infective agents, anti-inflammatory agents, antiscarring or antiproliferative agents, chemotherapeutic or antineoplastic agents, cytokines, decongestants, healing promotion agents and vitamins, hyperosmolar agents, immunomodulator or immunosuppressive agents, leukotriene modifiers, mucolytics, narcotic analgesics, small molecules, tyrosine kinase inhibitors, peptides, proteins, nucleic acids, vasoconstrictors, and combinations thereof.",
    "6. The device of claim 5 wherein the active agent comprises an anti-inflammatory agent.",
    "7. The device of claim 6 wherein the anti-inflammatory agent comprises a steroidal anti-inflammatory agent.",
    "8. The device of claim 7 wherein the steroidal anti-inflammatory agent is selected from the group consisting of 21-acetoxypregnenolone, alclometasone, algestone, amcinonide, beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol, clobetasone, clocortolone, cloprednol, corticosterone, cortisone, cortivazol, deflazacort, desonide, desoximetasone, dexamethasone, diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort, flucloronide, flumethasone, flunisolide, fluocinolone acetonide, fluocinonide, fluocortin butyl, fluocortolone, fluorometholone, fluperolone acetate, fluprednidene acetate, fluprednisolone, flurandrenolide, fluticasone propionate, formocortal, halcinonide, halobetasol propionate, halometasone, halopredone acetate, hydrocortamate, hydrocortisone, loteprednol etabonate, mazipredone, medrysone, meprednisone, methylprednisolone, mometasone furoate, paramethasone, prednicarbate, prednisolone, prednisolone 25-diethylamino-acetate, prednisolone sodium phosphate, prednisone, prednival, prednylidene, rimexolone, tixocortol, triamcinolone, triamcinolone acetonide, triamcinolone benetonide, triamcinolone hexacetonide, and derivatives and combinations thereof.",
    "9. The device of claim 8 wherein the anti-inflammatory agent comprises mometasone furoate.",
    "10. The device of claim 5 wherein the active agent comprises an anti-infective agent.",
    "11. The device of claim 10 wherein the anti-infective agent is selected from the group consisting of antibacterial agents, antifungal agents, antiparasitic agents, antiviral agents, antiseptics, and combinations thereof.",
    "12. The device of claim 11 wherein the anti-infective agent comprises an antibacterial agent.",
    "13. The device of claim 12 wherein the antibacterial agent is selected from the group consisting of aminoglycosides, amphenicols, ansamycins, β-lactams, lincosamides, macrolides, nitrofurans, quinolones, sulfonamides, sulfones, tetracyclines, vancomycin, and any derivatives and combinations thereof.",
    "14. The device of claim 1 wherein the active agent is included in a coating on the device.",
    "15. The device of claim 14 wherein the coating comprises a polymer.",
    "16. The device of claim 15 wherein the polymer comprises a biodegradable polymer.",
    "17. The device of claim 1 further comprising a biocompatible material.",
    "18. The device of claim 17 wherein the biocompatible material comprises a biodegradable polymer, a nonbiodegradable polymer, a metal, or a combination thereof.",
    "19. The device of claim 18 wherein the biocompatible material comprises a biodegradable polymer.",
    "20. The device of claim 19 wherein the biodegradable polymer is selected from the group consisting of a poly(lactide); a poly(glycolide); a poly(lactide-co-glycolide); a poly(lactic acid); a poly(glycolic acid); a poly(lactic acid-co-glycolic acid); poly(lactide)/poly(ethylene glycol) copolymers; a poly(glycolide)/poly(ethylene glycol) copolymers; a poly(lactide-co-glycolide)/poly(ethylene glycol) copolymers; a poly(lactic acid)/poly(ethylene glycol) copolymers; a poly(glycolic acid)/poly(ethylene glycol) copolymers; a poly(lactic acid-co-glycolic acid)/poly(ethylene glycol) copolymers; a poly(caprolactone); poly(caprolactone)/poly(ethylene glycol) copolymers; a poly(orthoester); a poly(phosphazene); a poly(hydroxybutyrate) or a copolymer including a poly(hydroxybutyrate); a poly(lactide-co-caprolactone); a polycarbonate; a polyesteramide; a polyanhidride; a poly(dioxanone); a poly(alkylene alkylate); a copolymer of polyethylene glycol and a polyorthoester; a biodegradable polyurethane; a poly(amino acid); a polyetherester; a polyacetal; a polycyanoacrylate; a poly(oxyethylene)/poly(oxypropylene) copolymer; and blends and copolymers thereof.",
    "21. The device of claim 20 wherein the biodegradable polymer comprises a lactide/glycolide polymer.",
    "22. The device of claim 18 wherein the biocompatible material comprises a nonbiodegradable polymer.",
    "23. The device of claim 22 wherein the nonbiodegradable polymer is selected from the group consisting of poly(ethylene vinyl acetate), poly(vinyl acetate), silicone polymers, polyurethanes, polysaccharides such as a cellulosic polymers and cellulose derivatives, acyl substituted cellulose acetates and derivatives thereof, copolymers of poly(ethylene glycol) and poly(butylene terephthalate), polystyrenes, polyvinyl chloride, polyvinyl fluoride, poly(vinyl imidazole), chorosulphonated polyolefins, polyethylene oxide, and copolymers and blends thereof.",
    "24. The device of claim 18 wherein the biocompatible material comprises a metal.",
    "25. The device of claim 24 wherein the metal is selected from the group consisting of cobalt, chromium, nickel, platinum, stainless steel, titanium, tantalum, nickel-titanium, and alloys and combinations thereof.",
    "26. The device of claim 1 optionally comprising an ostial portion, a sinus portion, or a nasal portion.",
    "27. The device of claim 26 comprising an ostial portion, wherein the ostial portion delivers an active agent to a sinus ostium.",
    "28. The device of claim 27 wherein the ostial portion delivers the same active agent to the sinus ostium as is delivered to the osteomeatal complex.",
    "29. The device of claim 27 wherein the ostial portion delivers a different active agent to the sinus ostium than the active agent delivered to the osteomeatal complex.",
    "30. The device of claim 26 comprising a sinus portion, wherein the sinus portion delivers an active agent to a sinus cavity.",
    "31. The device of claim 30 wherein the sinus portion delivers the same active agent to the sinus cavity as is delivered to the osteomeatal complex.",
    "32. The device of claim 31 wherein the sinus portion delivers the same active agent to the sinus cavity as is delivered to the osteometal complex, but with a different dosage or release profile.",
    "33. The device of claim 30 wherein the sinus portion delivers a different active agent to the sinus cavity than the active agent delivered to the osteomeatal complex.",
    "34. The device of claim 1 wherein the device is configured for placement on, within, or between an uncinate process, an ethmoid bulla, a middle turbinate, a nasal wall, or combinations thereof.",
    "35. The device of claim 34 wherein the device is placed on the uncinate process.",
    "36. The device of claim 34 wherein the device is placed between the uncinate process and the ethmoid bulla.",
    "37. The device of claim 34 wherein the device is placed between the uncinate process and the middle turbinate.",
    "38. The device of claim 34 wherein the device is placed between the ethmoid bulla and the middle turbinate.",
    "39. The device of claim 34 wherein the device is placed between the middle turbinate and the nasal wall.",
    "40. The device of claim 34 wherein the device is adapted for filling the space between at least two of the uncinate process, the ethmoid bulla, the middle turbinate, and the nasal wall.",
    "41. The device of claim 40 wherein the device is adapted to fill the space between the uncinate process and middle turbinate.",
    "42. The device of claim 40 wherein the device is adapted to fill the space between the ethmoid bulla and the middle turbinate.",
    "43. The device of claim 40 comprising a gel.",
    "44. The device of claim 40 comprising a foam.",
    "45. The device of claim 40 wherein the active agent is encapsulated in a microsphere.",
    "46. The device of claim 44 wherein the microsphere is a hydrocolloid microsphere.",
    "47. The device of claim 34 wherein the device is adapted for passive fixation.",
    "48. The device of claim 47 wherein the device is adapted for passive fixation between the uncinate process and the middle turbinate.",
    "49. The device of claim 47 wherein the device is adapted for passive fixation between the uncinate process and the ethmoid bulla.",
    "50. The device of claim 47 wherein the device is adapted for passive fixation between the ethmoid bulla and the middle turbinate.",
    "51. The device of claim 47 wherein the device is adapted for passive fixation between the middle turbinate and the nasal wall.",
    "52. The device of claim 47 wherein the device comprises a coil configured to self-adjust its diameter to remain passively fixed within the osteomeatal complex.",
    "53. The device of claim 47 wherein the device comprises a mucoadhesive material.",
    "54. The device of claim 34 wherein the device is adapted for active fixation.",
    "55. The device of claim 54 wherein the device is adapted for active fixation on or within the uncinate process.",
    "56. The device of claim 54 wherein the device is adapted for active fixation between the uncinate process and the middle turbinate.",
    "57. The device of claim 54 wherein the device is adapted for active fixation between the uncinate process and the ethmoid bulla.",
    "58. The device of claim 54 wherein the device is adapted for active fixation between the ethmoid bulla and the middle turbinate.",
    "59. The device of claim 54 wherein the device is adapted for active fixation between the middle turbinate and the nasal wall.",
    "60. The device of claim 54 wherein the device comprises one or more anchoring elements for actively fixing the device.",
    "61. The device of claim 54 wherein the device is configured to pierce and secure itself within one or more structures of the osteomeatal complex.",
    "62. The device of claim 61 wherein the device has a first collapsed configuration prior to deployment, and a second expanded configuration after deployment.",
    "63. The device of claim 54 wherein the device is configured to pierce and secure itself within the uncinate process.",
    "64. The device of claim 54 wherein the device is configured to pierce and secure itself within the ethmoid bulla.",
    "65. The device of claim 1 wherein the device cannulates a sinus cavity.",
    "66. The device of claim 1 wherein the device is configured to maintain patency of a sinus ostia.",
    "67. The device of claim 1 wherein the device is configured to stabilize the middle turbinate.",
    "68. The device of claim 1 wherein the device self-assembles while resident within the body.",
    "69. A method for treating sinusitis or a related respiratory condition affecting the osteomeatal complex comprising placing a device having an active agent to treat the condition within the osteomeatal complex and delivering a therapeutically effective amount of the active agent locally to the osteomeatal complex over a sustained period of time.",
    "70. The method of claim 69 wherein the related respiratory condition is selected from the group consisting of inflammation of the osteomeatal complex, osteometal complex or sinus cavity inflammation due to surgery; sinusitis; rhinitis; rhinosinusitis; upper respiratory tract infections; otitis media; bronchitis; bronchiolitis; asthma; tonsillitis and other chronic diseases of the tonsils and adenoids; laryngitis; tracheitis; nasal and sinus polyposis; neoplasms of the large and small airways; and nasal, sinus, and nasopharynx tumors.",
    "71. The method of claim 70 wherein the condition is inflammation of the osteomeatal complex.",
    "72. The method of claim 70 wherein the condition is nasal or sinus polyposis.",
    "73. The method of claim 69 wherein the active agent is delivered to the uncinate process.",
    "74. The method of claim 69 wherein the active agent is delivered to the ethmoid bulla.",
    "75. The method of claim 69 wherein the device is placed within the osteomeatal complex using a conduit having a lumen.",
    "76. The method of claim 75 wherein the conduit is configured to pierce one or more structures of the osteomeatal complex.",
    "77. The method of claim 69 further comprising use of a tool to aid visualization.",
    "78. The method of claim 77 wherein the tool is an endoscope.",
    "79. The method of claim 69 wherein the active agent is selected from the group consisting of anticholinergic agents, antihistamines, anti-infective agents, anti-inflammatory agents, antiscarring or antiproliferative agents, chemotherapeutic or antineoplastic agents, cytokines, decongestants, healing promotion agents and vitamins, hyperosmolar agents, immunomodulator or immunosuppressive agents, leukotriene modifiers, mucolytics, narcotic analgesics, small molecules, tyrosine kinase inhibitors, peptides, proteins, nucleic acids, biological macromolecules, vasoconstrictors, and combinations thereof.",
    "80. The device of claim 79 wherein the active agent comprises an anti-inflammatory agent.",
    "81. The device of claim 80 wherein the anti-inflammatory agent comprises a steroidal anti-inflammatory agent.",
    "82. The device of claim 81 wherein the steroidal anti-inflammatory agent is selected from the group consisting of 21-acetoxypregnenolone, alclometasone, algestone, amcinonide, beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol, clobetasone, clocortolone, cloprednol, corticosterone, cortisone, cortivazol, deflazacort, desonide, desoximetasone, dexamethasone, diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort, flucloronide, flumethasone, flunisolide, fluocinolone acetonide, fluocinonide, fluocortin butyl, fluocortolone, fluorometholone, fluperolone acetate, fluprednidene acetate, fluprednisolone, flurandrenolide, fluticasone propionate, formocortal, halcinonide, halobetasol propionate, halometasone, halopredone acetate, hydrocortamate, hydrocortisone, loteprednol etabonate, mazipredone, medrysone, meprednisone, methylprednisolone, mometasone furoate, paramethasone, prednicarbate, prednisolone, prednisolone 25-diethylamino-acetate, prednisolone sodium phosphate, prednisone, prednival, prednylidene, rimexolone, tixocortol, triamcinolone, triamcinolone acetonide, triamcinolone benetonide, triamcinolone hexacetonide, and derivatives and combinations thereof.",
    "83. The device of claim 82 wherein the anti-inflammatory agent comprises mometasone furoate.",
    "84. The device of claim 79 wherein the active agent comprises an anti-infective agent.",
    "85. The device of claim 84 wherein the anti-infective agent is selected from the group consisting of antibacterial agents, antifungal agents, antiparasitic agents, antiviral agents, antiseptics, and combinations thereof.",
    "86. The device of claim 85 wherein the anti-infective agent comprises an antibacterial agent.",
    "87. The device of claim 86 wherein the antibacterial agent is selected from the group consisting of aminoglycosides, amphenicols, ansamycins, β-lactams, lincosamides, macrolides, nitrofurans, quinolones, sulfonamides, sulfones, tetracyclines, vancomycin, and any derivatives and combinations thereof.",
    "88. A method for treating a condition affecting the osteomeatal complex comprising delivering a therapeutically effective amount of an active agent for sustained release to an uncinate process to treat the condition.",
    "89. A method for treating a condition affecting the osteomeatal complex comprising delivering a therapeutically effective amount of an active agent for sustained release to an ethmoid bulla to treat the condition."
  ],
  "description_excerpt": "The devices, methods, and kits described here are in the field of medical devices and local drug delivery to treat sinusitis and its related respiratory conditions. Specifically, the treatment of osteomeatal complex inflammation is described.\n\nThe osteomeatal complex (OMC) is a key area in the pathogenesis of sinusitis. The OMC includes the middle meatus and the narrow channels that provide the pathway for mucociliary clearance and ventilation of the anterior ethmoid, maxillary, and frontal sinuses. Thus, relatively minor swelling in this area, such as that associated with upper respiratory tract infections or allergic rhinitis, may lead to obstruction of any one or combination of these sinus cavities. As a result of blockage in the OMC, sinusitis may develop due to the accumulation of mucus, inflammatory cells, and bacteria, presence of low oxygen tension, and impaired immune responses in the OMC and surrounding tissues.\n\nMedical treatment regimens used for sinusitis may be used to treat OMC inflammation. Typical medical treatment regimes may include a combination of oral antibiotics, topical or oral decongestants, topical steroid nasal sprays or solutions, or injectable oral steroids such as prednisone. Systemic methods (e.g., oral and injectables) commonly have significant disadvantages relating to side effects from the exposure of the entire body to the effects of the active agent.",
  "cpc": [
    "A61M 31/00",
    "A61K 9/0043",
    "A61L 31/08",
    "A61L 31/148",
    "A61L 31/16",
    "A61P 43/00"
  ],
  "ipc": [
    "A61F 2/18",
    "A61P 43/00",
    "A61K 47/00",
    "A01N 25/00",
    "A61F 13/00"
  ],
  "inventors": [
    "Patrick A. Arensdorf",
    "Danielle L. Biggs",
    "Rodney Brenneman",
    "David B. Downie",
    "Donald J. Eaton",
    "Thomas R. Tice"
  ],
  "filing_date": "2007-07-09",
  "publication_date": "2009-01-15",
  "priority_date": "2006-07-10",
  "application_number": "US-77515707-A",
  "family_id": "40253341",
  "cited_by_count": 167,
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