Device and methods for treating paranasal sinus conditions

• US 8,858,974 B2
• Filed: 11/13/2008
• Issued: 10/14/2014
• Est. Priority Date: 04/04/2005
• Status: Active Grant

• Current Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Original Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Inventors: Eaton, Donald J., Tice, Thomas R., Downie, David B., Arensdorf, Patrick A., Brenneman, Rodney, Biggs, Danielle L.
• Primary Examiner(s): Sasan, Aradhana
• Application Number:
  US12/270,695
• Publication Number:
  US 20090156980A1
• Time in Patent Office: 2,161 Days
• Field of Search: 424/422, 604/19, 606/151
• US Class Current: 424/422
• 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. An implantable device for treating a paranasal sinus condition comprising:

a cavity member at a distal end of the device;

a nasal portion at a proximal end of the device, the nasal portion comprising a first plate member;

a tubular ostial member connecting the cavity member and the nasal portion; and

one or more active agents for sustained release,

wherein the tubular ostial member comprises a drainage lumen extending therethrough and that passes through at least one opening in the first plate member.

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 wherein the ostial member is configured to maintain patency of the sinus ostium.

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

10. The device of claim 1 wherein the ostial member comprises a sheet-like material configured to anchor the cavity member within the sinus cavity.

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

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

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

14. 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.

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

16. The device of claim 1 wherein the cavity member, nasal portion, and ostial member comprise a biocompatible material.

17. The device of claim 16 wherein the cavity member, nasal portion, and ostial member comprise the same biocompatible material.

18. The device of claim 16 wherein the cavity member, nasal portion, and ostial member comprise different biocompatible materials.

19. The device of claim 16 wherein the biocompatible material comprises a biodegradable polymer, a nonbiodegradable polymer, a metal, or a combination thereof.

20. The device of claim 19 wherein the biocompatible material comprises a biodegradable polymer.

21. The device of claim 20 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.

22. The device of claim 21 wherein the biodegradable polymer comprises a lactide/glycolide polymer.

23. The device of claim 16 wherein the biocompatible material comprises a nonbiodegradable polymer.

24. The device of claim 23 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.

25. The device of claim 16 wherein the biocompatible material comprises a metal.

26. The device of claim 25 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.

27. The device of claim 1 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.

28. The device of claim 27 wherein the one or more active agents comprises an anti-inflammatory agent.

29. The device of claim 28 wherein the anti-inflammatory agent comprises a steroidal anti-inflammatory agent.

30. The device of claim 29 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.

31. The device of claim 30 wherein the anti-inflammatory agent comprises mometasone furoate.

32. The device of claim 27 wherein the active agent comprises an anti-infective agent.

33. The device of claim 32 wherein the anti-infective agent is selected from the group consisting of antibacterial agents, antifungal agents, antiparasitic agents, antiviral agents, antiseptics, and combinations thereof.

34. The device of claim 33 wherein the anti-infective agent comprises an antibacterial agent.

35. The device of claim 34 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.

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

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

38. The device of claim 37 wherein the coating further comprises a polymer.

39. The device of claim 38 wherein the polymer comprises a biodegradable polymer.

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

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

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

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

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

45. 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.

46. The device of claim 45 wherein the paranasal sinus condition is sinus inflammation due to functional endoscopic sinus surgery (FESS).

47. The device of claim 45 wherein the paranasal sinus condition is rhinosinusitis.

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

49. The device of claim 48 wherein the substance is selected from the group consisting of alcohol, chlorhexidine, iodine, triclosan, hexachlorophene, silver-based agents, and combinations thereof.