Sinus Tube

• US 20080294255A1
• Filed: 05/04/2007
• Published: 11/27/2008
• Est. Priority Date: 05/23/2006
• Status: Abandoned Application

• Current Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Original Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Inventors: Gonzales, Donald Albert
• Application Number:
  US11/744,566
• Publication Number:
  US 20080294255A1
• Time in Patent Office: Days
• US Class Current: 623/10
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

The inventive sinus tube provide a non-surgical approach to sinus disease. The tube once inserted in the ostia of a paranasal sinus provides the proper aeration and drainage of the sinus cavity. The tube stops the cycle of inflammation, stasis, infection, and continued inflammation associated with sinus disease. The tubes are inserted into the natural ostia of a patient or are inserted after a surgical procedure to enlarge the ostia. The invention also provides an instrument for inserting the inventive tube, methods of using the tube, and kits including the tubes.

Claims

1. An implantable tube for insertion into the wall of a nasal cavity for venting a sinus comprising:

a tubular structure having first and second open ends and a lumen of a diameter of 0.5 mm to 5 mm extending there between and of a length of 0.5 mm to 3 mm;

a first flange integrally formed on first said opening; and

a second flange integrally formed on second said opening.

2. The tube of claim 1, wherein the tube is one piece.

3. The tube of claim 1, wherein the tube is molded.

4. The tube of claim 1, wherein the tube is extruded.

5. The tube of claim 1, wherein the tube is flexible.

6. The tube of claim 1, wherein the tube is rigid.

7. The tube of claim 1, wherein the tube is made of a biodegradable material.

8. The tube of claim 7, wherein the biodegradable material is absorbed in approximately 3-4 months.

9. The tube of claim 7, wherein the biodegradable material is absorbed in approximately 6 months.

10. The tube of claim 7, wherein the biodegradable material is absorbed in approximately 12 months.

11. The tube of claim 1, wherein the tube is made of a non-biodegradable material.

12. The tube of claim 1, wherein the tube is made of silicone.

13. The tube of claim 1, wherein the tube is made of a metal or alloy.

14. The tube of claim 1, wherein the tube is made of a polymer.

15. The tube of claim 1, wherein the tube is made of a biodegradable, biocompatible polymer.

16. The tube of claim 1, wherein the tube is made of a polymer selected from the group consisting of polyesters, polyurethanes, polyvinyl chloride, polyalkylenes, polyolefins, polyanhydrides, polyamides, polycarbonates, polycarbamates, polyacrylates, polymethacrylates, polystyrenes, polyureas, polyethers, polyphosphazenes, poly(ortho esters), polycarbonates, polyfumarates, polyarylates, polystyrenes, or polyamines.

17. The sent of claim 1, wherein the tube is made of PLGA.

18. The tube of claim 1, wherein the tube is made of a polyester.

19. The tube of claim 1, wherein the tube is silastic.

20. The tube of claim 1, wherein the sinus being vented is the maxillary sinus.

21. The tube of claim 1, wherein the sinus being vented is the sphenoid sinus.

22. The tube of claim 1, wherein the sinus being vented is the frontal sinus.

23. The tube of claim 1, wherein the tube is capable of being inserted without destruction of tissue around the natural ostia of the sinus.

24. The tube of claim 1, wherein the diameter of the first flange is 1.2 times the diameter of the lumen.

25. The tube of claim 1, wherein the diameter of the second flange is 1.2 times the diameter of the lumen.

26. The tube of claim 1, wherein the diameter of the second flange is 1.5 times the diameter of the lumen.

27. The tube of claim 1, wherein the diameter of the second flange is 2 times the diameter of the lumen.

28. The tube of claim 1, wherein the first flange is circular shaped, linear shaped, X-shaped, triangular shaped, rectangular shaped, pentagonal shaped, or hexagonal shaped.

29. The tube of claim 1, wherein the second flange is circular shaped, linear shaped, X-shaped, triangular shaped, rectangular shaped, pentagonal shaped, or hexagonal shaped.

30. The tube of claim 1, wherein the tube is coated.

31. The tube of claim 30, wherein the tube is coated with Teflon.

32. The tube of claim 30, wherein the tube is coated with hyaluronidate.

33. The tube of claim 30, wherein the coating is collagen.

34. The tube of claim 30, wherein the coating is a polymer.

35. The tube of claim 30, wherein the coating comprises a pharmaceutical agent.

36. The tube of claim 30, wherein the tube comprises a pharmaceutical agent.

37. The tube of claim 35 or 36, wherein the pharmaceutical agent is selected from the group consisting of decongestants, anti-histamines, corticosteroids, anti-inflammatory agents, and antibiotics.

39. A device for introducing the tube of claim 1 into a an ostia of a sinus comprising:

a handle; and

an elongated tip for engaging the tube to be inserted and then disengaging the tube once the tube has been place in an ostia.

40. A system comprising a tube of claim 1 and a device of claim 39.

41. A method of introducing a tube of claim 1 into a subject, the method comprising steps of:

visualizing the ostia into which the tube is to be inserted;

introducing the tube into the ostia using the device of claim 39; and

disengaging the tube from the device.

42. The method of claim 41, wherein the step of introducing comprising introducing the tube to a natural ostia, wherein no tissue has been removed from around the ostia.

43. The method of claim 41 further comprising the step of performing a uncinectomy.

44. A kit comprising a sinus tube of claim 1.

45. The kit of claim 44 further comprising an instrument for inserting the tube in an ostia of a paranasal sinus.

46. The kit of claim 44 further comprising instructions for using the sinus tube.

38. An threaded, implantable tube for insertion into the wall of a nasal cavity for venting a sinus comprising a tubular structure having first and second open ends and a lumen of a diameter of 0.5 mm to 5 mm extending there between and of a length of 0.5 mm to 3 mm, wherein the tubular structure include a screw-like thread running along the long axis of the structure on the outside of the structure.