Device and methods for treating paranasal sinus conditions

• US 20070005094A1
• Filed: 04/04/2006
• Published: 01/04/2007
• Est. Priority Date: 04/04/2005
• Status: Active Grant

• Current Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Original Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Inventors: Brenneman, Rodney, Biggs, Danielle, Arensdorf, Patrick, Eaton, Donald, Downie, David, Tice, Thomas
• Granted Patent: US 8,025,635 B2
• Time in Patent Office: Days
• US Class Current: 606/199
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61F 2/186 Nose parts
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 47/14 Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61K 9/70 Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug hollow drug-filled fibres A61K9/0092
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61P 27/16 Otologicals
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Described here are paranasal sinus devices for treating paranasal sinus conditions. The devices include a cavity member, ostial member, and nasal portion. One or more of the cavity member, ostial member, and nasal portion may deliver an active agent for sustained release to treat the paranasal sinus condition. Exemplary paranasal sinus conditions are sinus inflammation due to functional endoscopic sinus surgery (FESS) and rhinosinusitis.

Claims

1. A device for treating a paranasal sinus condition comprising a cavity member, a nasal portion, and one or more active agent for sustained release.

2. The device of claim 1 wherein the cavity member has a first collapsed configuration that permits the device to pass through a sinus ostium or surgically created fenestration and a second expanded configuration after placement into a sinus cavity.

3. The device of claim 2 wherein the cavity member in the expanded configuration has a surface area to volume ratio that is substantially unchanged from that of the collapsed configuration.

4. The device of claim 2 wherein the cavity member in the expanded configuration substantially contacts the mucosal surface of the sinus cavity.

5. The device of claim 1 wherein the one or more active agents are released from the cavity member.

6. The device of claim 1 wherein the one or more active agents are released from the nasal portion.

7. The device of claim 1 wherein the one or more active agents are released from the cavity member and the nasal portion.

8. The device of claim 1 further comprising an ostial member.

9. The device of claim 8 wherein the ostial member is configured to maintain patency of the sinus ostium.

10. The device of claim 8 wherein the ostial member comprises one or more pliable filaments configured to anchor the cavity member within the sinus cavity.

11. The device of claim 8 wherein the ostial member comprises a sheet-like material configured to anchor the cavity member within the sinus cavity.

12. The device of claim 8 wherein the one or more active agents are released from the ostial member.

13. The device of claim 8 wherein the one or more active agents are released from the ostial member and the cavity member.

14. The device of claim 8 wherein the one or more active agents are released from the ostial member and the nasal portion.

15. The device of claim 1 wherein the nasal portion comprises one or more pliable filaments configured to anchor the cavity member within the sinus cavity.

16. The device of claim 1 wherein the cavity member comprises one or more pliable filaments configured to prevent displacement of the cavity member from the sinus cavity.

17. The device of claim 1 wherein the cavity member comprises one or more pliable filaments configured to anchor the ostial portion.

18. The device of claim 8 wherein the cavity member, nasal portion, and ostial member comprise a biocompatible material.

19. The device of claim 18 wherein the cavity member, nasal portion, and ostial member comprise the same biocompatible material.

20. The device of claim 18 wherein the cavity member, nasal portion, and ostial member comprise different biocompatible materials.

21. The device of claim 18 wherein the biocompatible material comprises a biodegradable polymer, a nonbiodegradable polymer, a metal, or a combination thereof.

22. The device of claim 21 wherein the biocompatible material comprises a biodegradable polymer.

23. The device of claim 22 wherein the biodegradable polymer is selected from the group consisting of 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 or copolymers thereof.

24. The device of claim 23 wherein the biodegradable polymer comprises a lactide/glycolide polymer.

25. The device of claim 18 wherein the biocompatible material comprises a nonbiodegradable polymer.

26. The device of claim 25 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.

27. The device of claim 18 wherein the biocompatible material comprises a metal.

28. The device of claim 27 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.

29. The device of claim 1 or 8 wherein the one or more active agents are 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.

30. The device of claim 29 wherein the one or more active agents comprises an anti-inflammatory agent.

31. The device of claim 30 wherein the anti-inflammatory agent comprises a steroidal anti-inflammatory agent.

32. The device of claim 31 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.

33. The device of claim 32 wherein the anti-inflammatory agent comprises mometasone furoate.

34. The device of claim 29 wherein the active agent comprises an anti-infective agent.

35. The device of claim 34 wherein the anti-infective agent is selected from the group consisting of antibacterial agents, antifungal agents, antiparasitic agents, antiviral agents, antiseptics, and combinations thereof.

36. The device of claim 35 wherein the anti-infective agent comprises an antibacterial agent.

37. The device of claim 36 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.

38. The device of claim 1 wherein the device is configured to differentially release the one or more active agents.

39. The device of claim 1 wherein the active agent is included in a coating on the device.

40. The device of claim 39 wherein the coating further comprises a polymer.

41. The device of claim 40 wherein the polymer comprises a biodegradable polymer.

42. The device of claim 1 or 8 comprising about 0.01% to about 40% of the one or more active agents by weight.

43. The device of claim 1 or 8 comprising about 0.01% to about 30% of the one or more active agents by weight.

44. The device of claim 1 or 8 comprising about 0.01% to about 20% of the one or more active agents by weight.

45. The device of claim 1 or 8 comprising about 0.01% to about 10% of the one or more active agents by weight.

46. The device of claim 1 or 8 comprising about 0.01% to about 1% of the one or more active agents by weight.

47. The device of claim 1 wherein the paranasal sinus condition is selected from the group consisting of sinus inflammation due to functional endoscopic sinus surgery (FESS);

acute sinusitis;

chronic sinusitis;

allergic rhinitis;

rhinosinusitis;

sinusitis that recurs after FESS;

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.

48. The device of claim 47 wherein the paranasal sinus condition is sinus inflammation due to functional endoscopic sinus surgery (FESS).

49. The device of claim 47 wherein the paranasal sinus condition is rhinosinusitis.

50. The device of claim 1 further comprising a substance that prevents biofilm formation.

51. The device of claim 50 wherein the substance is selected from the group consisting of alcohol, chlorhexidine, iodine, triclosan, hexachlorophene, silver-based agents, and combinations thereof.

52. The device of claim 1 wherein the surface of the device has been treated by a process altering the physical properties of the surface of the device in order to prevent biofilm formation.

67. The device of claim 51 wherein the cavity member has a first collapsed configuration that permits it to pass through a sinus ostium or surgically created fenestration, and a second expanded configuration after placement into a sinus cavity.

68. The device of claim 67 wherein the cavity member at least partially conforms to the shape of the sinus cavity and substantially contacts the mucosal surface of the sinus cavity in the expanded configuration.

69. The device of claim 51 wherein the active agent is released from the cavity member.

53. A device for treating a paranasal sinus condition comprising:

a) an ostial member having a proximal end and a distal end;

b) a cavity member attached to the ostial member distal end;

c) optionally, a nasal portion attached to the ostial member proximal end; and

d) an active agent for sustained release,

wherein the cavity member, the ostial member, and optional nasal portion comprise a biocompatible material and the active agent is released from the cavity member, the ostial member, the nasal portion, or any combination thereof, to treat the paranasal sinus condition.

54. The device of claim 53 wherein the biocompatible material comprises a biodegradable polymer, a nonbiodegradable polymer, a metal, or a combination thereof.

55. The device of claim 54 wherein the biocompatible material comprises a biodegradable polymer.

56. The device of claim 55 wherein the biodegradable polymer is selected from the group consisting of poly(lactide)s;

poly(glycolide)s;

poly(lactide-co-glycolide)s;

poly(lactic acid)s;

poly(glycolic acid)s;

poly(lactic acid-co-glycolic acid)s;

poly(caprolactone)s;

poly(orthoester)s;

poly(phosphazene)s;

poly(hydroxybutyrate)s or copolymers including poly(hydroxybutyrate);

poly(lactide-co-caprolactone)s;

polycarbonates;

polyesteramides;

polyanhidrides;

poly(dioxanone)s;

poly(alkylene alkylate)s;

copolymers of polyethylene glycol and a polyorthoester;

biodegradable polyurethanes;

poly(amino acid)s;

polyetheresters;

polyacetals;

polycyanoacrylates;

poly(oxyethylene)/poly(oxypropylene) copolymers, and blends and copolymers thereof.

57. The device of claim 56 wherein the biodegradable polymer comprises a lactide/glycolide polymer.

58. The device of claim 54 wherein the biocompatible material comprises a nonbiodegradable polymer.

59. The device of claim 58 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.

60. The device of claim 54 wherein the biocompatible material comprises a metal.

61. The device of claim 60 wherein the metal is selected from the group consisting of cobalt, chromium, nickel, platinum, stainless steel, titanium, tantalum, nickel-titanium, and any alloy or combination thereof.

62. The device of claim 53 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.

63. The device of claim 62 wherein the active agent comprises an anti-inflammatory agent.

64. The device of claim 63 wherein the anti-inflammatory agent comprises a steroidal anti-inflammatory agent.

65. The device of claim 64 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.

66. The device of claim 65 wherein the active agent comprises mometasone furoate.

70. The device of claim 53 wherein the cavity member comprises a biodegradable polymer, a nonbiodegradable polymer, a metal, or combinations thereof.

71. The device of claim 70 wherein the cavity member comprises a biodegradable polymer.

72. The device of claim 71 wherein the biodegradable polymer comprises a lactide/glycolide polymer.

73. The device of claim 53 wherein the cavity member comprises one or more pliable filaments.

74. The device of claim 73 wherein the one or more pliable filaments are configured to form a multi-looped structure.

75. The device of claim 74 wherein the multiple loops are concentric to one another.

76. The device of claim 53 wherein the cavity member self-expands.

77. The device of claim 53 wherein the cavity member expands by exertion of an expansive force.

78. The device of claim 77 wherein the expansive force is provided by expansion of a balloon.

79. The device of claim 53 wherein the cavity member is configured to prevent migration of the device out of a sinus.

80. The device of claim 53 wherein the ostial member comprises a biodegradable polymer, a nonbiodegradable polymer, a metal, or combinations thereof.

81. The device of claim 80 wherein the ostial member comprises a biodegradable polymer.

82. The device of claim 81 wherein the biodegradable polymer comprises a lactide/glycolide polymer.

83. The device of claim 53 wherein the ostial member is configured to form a tubular structure.

84. The device of claim 53 wherein the ostial member is configured to prevent migration of the device out of a sinus.

85. The device of claim 53 wherein the ostial member is configured to maintain patency of a sinus ostium.

86. The device of claim 53 wherein the active agent is released from the nasal portion.

87. The device of claim 53 wherein the nasal portion comprises a biodegradable polymer, a nonbiodegradable polymer, a metal, or combinations thereof.

88. The device of claim 87 wherein the nasal portion comprises a biodegradable polymer.

89. The device of claim 88 wherein the nasal portion comprises a lactide/glycolide polymer.

90. The device of claim 53 wherein the nasal portion is configured as a plurality of spokes.

91. The device of claim 53 wherein the nasal portion is configured to prevent migration of the device out of a sinus.

92. A system for treating a paranasal sinus condition comprising:

a) a sinus inserter comprising a conduit having a lumen and a distal portion;

b) a paranasal sinus device within the lumen or releasably secured to the distal portion of the sinus inserter, the paranasal sinus device comprising a cavity member, a ostial member, and optionally a nasal portion,

wherein the cavity member has a first collapsed configuration that permits the device to pass through a sinus ostium or surgically created fenestration and a second expanded configuration after placement into a sinus cavity.

93. The system of claim 92 wherein the paranasal sinus device is delivered into the sinus cavity by advancing a pusher through the conduit lumen.

94. The system of claim 92 further comprising a sheath.

95. The system of claim 94 wherein the paranasal sinus device is delivered into the sinus cavity by retracting the sheath to deploy the nasal portion and ostial member and expand the cavity member.

96. The system of claim 92 wherein the sinus inserter is preloaded with the paranasal sinus device.

97. The system of claim 92 wherein the paranasal sinus condition is sinus inflammation due to functional endoscopic sinus surgery (FESS).

98. A method for treating a paranasal sinus condition comprising:

a) providing a paranasal sinus device comprising a cavity member, a ostial member, and optionally a nasal portion within or on a sinus inserter;

b) accessing a paranasal sinus with the sinus inserter;

c) deploying the paranasal sinus device so that the cavity member substantially contacts the mucosal surface of the paranasal sinus after expansion.

99. The method of claim 98 wherein the paranasal sinus device releases an active agent to treat the paranasal sinus condition for about one week.

100. The method of claim 98 wherein the paranasal sinus device releases an active agent to treat the paranasal sinus condition for about two weeks.

101. The method of claim 98 wherein the paranasal sinus device releases an active agent to treat the paranasal sinus condition for about three weeks.

102. The method of claim 98 wherein the paranasal sinus device releases an active agent to treat the paranasal sinus condition for about one month.

103. A device configured to deliver an active agent and to prevent lateralization of the middle turbinate.

104. The device of claim 103 wherein the device is configured to deliver an active agent in a sustained release fashion.

105. A device configured to deliver an active agent and to prevent tissue adhesions in the area proximate a sinus cavity or proximate an area or an excised sinus cavity.

106. The device of claim 105 wherein the device is configured to deliver an active agent in a sustained release fashion.

107. A device for treating a paranasal sinus condition comprising an active agent dispersed within a biodegradable polymer matrix, wherein the device comprises a cavity member, an ostial member, and optionally a nasal portion, and exhibits an in vivo cumulative release profile in which a therapeutically effective amount of said active agent is maintained in a sinus tissue for at least about 35 days after implantation of the device.

108. The device of claim 107 in which a therapeutically effective amount of the active agent is maintained in the sinus tissue for at least about 25 days after implantation of the device.

109. The device of claim 107 in which a therapeutically effective amount of the active agent is maintained in the sinus tissue for at least about 14 days after implantation the device.

110. The device of claim 107 in which a therapeutically effective amount of the active agent is maintained in the sinus tissue for at least about four days after implantation the device.

111. The device of claim 107 with a drug release kinetic profile which achieves at least a therapeutically effective level of the active agent in the sinus tissue within 4 days after implantation.

112. The device of claim 107 with a drug release kinetic profile which sustains at least a therapeutically effective level of the active agent in the sinus tissue from day 4 through day 35 after implantation.

113. The device of claim 107 with a drug release kinetic profile which is substantially proportional and contemporaneous with the biodegradation and mass clearance of the device from the sinus cavity and sustains a therapeutically effective level of the active agent in the sinus tissue up until clearance of the device.

114. The device of claim 107 wherein the active agent is released with a drug release kinetic profile combining two or more of the profiles of claims 111, 112, and 113.