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1. (WO2011011373) DEVICES AND METHODS FOR MINIMALLY INVASIVE ACCESS TO SINUSES AND TREATMENT OF SINUSITIS
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CLAIMS

1. A method of treating a congested maxillary sinus comprising:

i. advancing an instrument capable of making a perforation into the ethmoid infundibulum;

ii. positioning the instrument at the anterior and inferior attachment of the uncinate process;

iii. making a perforation in the uncinate process;

iv. inserting a dilator through the perforation;

v. positioning the dilator in the ethmoid infundibulum; and

vi. dilating the ethmoid infundibulum by expanding the dilator.

2. The method of claim 1, further comprising:

vii. advancing the dilator into the natural ostium of the maxillary sinus; and viii. dilating the natural ostium of the maxillary sinus by expanding the dilator.

3. The method of claim 2, further comprising:

ix. advancing the dilator to the site of the perforation; and

x. dilating the perforation.

4. The method of claims 1, 2 or 3, wherein the dilator is a guide-free dilator.

5. The method of claims 1, 2 or 3 wherein the instrument capable of making a perforation is a backbiting hole punch.

6. The method of claims 1, 2 or 3 wherein the skeletal support structure of the uncinate process is maintained after making the perforation.

7. The method of claims 1, 2, 3 or 4 wherein the perforation has a diameter of about 3 mm. 8. The method of claims 1, 2, 3 or 4 wherein the dilator contains a balloon.

9. A method of treating a congested maxillary sinus comprising:

i. retracting the middle turbinate;

ii. advancing an instrument capable of making a perforation into the ethmoid infundibulum;

iii. positioning the instrument at the anterior and inferior attachment of the uncinate process;

iv. making a perforation in the uncinate process;

v. inserting a dilator through the perforation;

vi. positioning the dilator in the ethmoid infundibulum; and

vii. dilating the ethmoid infundibulum by expanding the dilator.

10. A method of treating a congested anterior ethmoid sinus comprising:

i. dilating the hiatus semilunaris superior;

ii. making a perforation in the anterior wall of the ethmoid bulla;

iii. advancing a dilator through the perforation until it reaches the ethmoid bulla ostium; and

iv. dilating the ethmoid bulla ostium.

11. A method of treating a congested anterior ethmoid sinus comprising:

i. dilating the hiatus semilunaris superior;

ii. making a perforation in the anterior wall of the ethmoid bulla;

iii. dilating the perforation;

iv. advancing a dilator through the perforation until it reaches the ethmoid bulla ostium; and

v. dilating the ethmoid bulla ostium.

12. The method of claims 11 or 12, wherein the dilator is a guide-free dilator.

13. The method of claim 11 or 12, further comprising retracting the middle turbinate prior to dilating the hiatus semilunaris superior.

14. A method of treating a congested anterior ethmoid sinus comprising:

i. retracting the middle turbinate;

ii. dilating the hiatus semilunaris superior;

iii. making a perforation in the anterior wall of the ethmoid bulla;

iv. advancing a dilator through the perforation until it reaches the ethmoid bulla ostium; and

v. dilating the ethmoid bulla ostium.

15. The method of claims 10, 11. 12, 13 or 14 wherein the dilator is a guide-free dilator. 16. The method of claim 15, wherein the guide-free dilator contains a balloon.

17. A method of treating a congested anterior ethmoid sinus comprising:

i. advancing an instrument into the antrum of the ethmoid bulla;

ii. engaging the ethmoid bulla ostium with the instrument;

iii. stretching the ethmoid bulla medially and anteriorly;

iv. advancing a dilator into the antrum of the ethmoid bulla; and

v. dilating the ethmoid bulla ostium

18. The method of claim 17, further comprising dilating the hiatus semilunaris superior. 19. The method of claims 17 and 18, further comprising retracting the middle turbinate prior to advancing the instrument into the antrum of the ethmoid bulla.

20. A method of treating a congested frontal sinus comprising:

i. positioning an endoscope into the middle meatus;

ii. advancing a guide-free dilator into the frontal ostium; and

iii. dilating the frontal ostium.

21. A method of treating a congested frontal sinus comprising:

i. retracting the middle turbinate;

ii. positioning an endoscope into the middle meatus;

iii. advancing a guide-free dilator into the frontal ostium; and

iv. dilating the frontal ostium.

22. A method of delivering a drug to a congested maxillary sinus comprising:

i. advancing an instrument capable of making a perforation into the ethmoid infundibulum;

ii. positioning the instrument at the anterior and inferior attachment of the uncinate process;

iii. making a perforation in the uncinate process;

iv. advancing a drug insertion instrument device through the perforation; and v. releasing a drug or drug delivery device in the maxillary sinus.

23. The method of claim 22, wherein the drug delivery device provides for controlled release of the drug.

24. A method of delivering a drug to a congested ethmoid sinus comprising:

i. advancing an instrument into the antrum of the ethmoid bulla;

ii. engaging the ethmoid bulla ostium with the instrument;

iii. stretching the ethmoid bulla medially and anteriorly;

iv. introducing a drug insertion instrument between the middle turbinate and the ethmoid bulla;

v. advancing the drug delivery instrument through the ethmoid bulla ostium; and vi. releasing a drug or drug delivery device into the ethmoid bulla.

25. The method of claim 24, wherein the drug delivery device provides for controlled release of the drug.

26. A method of treating a congested anterior ethmoid sinus comprising:

i. making a perforation in the anterior wall of the ethmoid bulla;

ii. advancing a drug insertion instrument through the perforation;

iii. releasing a drug or drug delivery device into the ethmoid bulla.

27. The method of claim 26, wherein the drug delivery device provides for controlled release of the drug.

28. A method of retracting the middle turbinate prior to a sinus procedure comprising: i. advancing a middle turbinate retractor in a compressed state into the axilla of the middle meatus between the middle turbinate and the lateral wall of the nose; and ii. expanding the middle turbinate retractor to reveal the relevant anatomy around an obstructed sinus cavity.

29. A method of retracting the middle turbinate prior to a sinus procedure comprising: i. advancing a middle turbinate retractor in a compressed state to a position between the lateral wall of the nose and the middle turbinate and inferior to the ethmoid bulla; and

ii. expanding the middle turbinate retractor to reveal the relevant anatomy around an obstructed sinus cavity.

30. A middle turbinate retractor comprising:

i. an expandable frame having two parallel sides and a rounded portion between the two sides, said expandable frame approximating a V-shape or a U-shape;

ii. an intervening pliable metal or plastic frame between the two sides of the expandable frame which enables expansion and compression of the frame; and iii. a pair of forceps on the inner portion of both sides of the expandable frame, wherein squeezing of the forceps results in expansion of the frame.

31. The middle turbinate retractor of claim 30, further comprising compressible pads on the outer surface of both sides of the expandable frame.

32. The middle turbinate retractor of claims 30 or 31, wherein the expandable frame expands to a width of greater than 3 mm and less than 10 mm.

33. A middle turbinate retractor comprising:

i. two rigid parallel platforms comprised of metal or plastic;

ii. a metal or plastic spring situated between the rigid platforms; and

iii. a pair of forceps on the outer surfaces of the parallel platform that allow for expansion and compression of the spring.

34. The middle turbinate retractor of claim 33, further comprising a pair of pads attached to the outer sides of the parallel platforms.

35. A middle turbinate retractor comprising:

i. two parallel arms that are capable of being expanded or compressed with respect to each other, said arms crossing each other, thereby forming an upper portion and a lower portion;

ii. a pair of expansion receptacles at the lower portion of each arm, whereby squeezing of said expansion receptacles results in expansion of the parallel arms iii. a ratchet arm connected at the upper portion of each parallel arm capable of holding the parallel arms in place.

36. A hole punch capable of making a perforation in the uncinate process comprising:

i. a shaft;

ii. a stationary platform mounted on said shaft;

iii. a blade attached to one end of the stationary platform;

iv. a mobile tapered flange containing a receptacle pivo tally connected to the stationary platform; and

v. a means of bringing the blade of the stationary platform and the receptacle of the mobile tapered flange together, thereby generating a perforation in the uncinate process.

37. The hole punch of claim 36, wherein the means of bringing the blade of the stationary platform and the receptacle of the mobile tapered flange together is a pair of handles on the proximal end of the shaft.

38. The hole punch of clam 36, wherein the shaft and the stationary platform are angled between 0 degrees and about 20 degrees with respect to each other.

39. The hole punch of claim 36, wherein the shaft and the stationary platform are angled at about 20 degrees with respect to each other.

40. The hole punch of claims 36, 37, 38 or 39 wherein the length of the mobile flange is in the range of from about 1.0 cm to about 2.0 cm.

41. The hole punch of claim 36, said blade being rounded so as to remove a circle of tissue in the uncinate process.

42. A guide-free dilator comprising:

i. a rigid shaft with a bottom portion and a top portion;

ii. a rigid handle mounted at the bottom portion of the rigid shaft; and

iii. a dilator segment mounted at the top portion of the rigid shaft, said dilator segment comprising a semiridgid shaft and a mounting balloon, wherein the top portion of the rigid shaft is angled in the range of from about 30 degrees to about 60 degrees. 43. The guide-free dilator of claim 42, wherein the top portion of the rigid shaft is angled at about 45 degrees.

44. The guide-free-dilator of claim 42, wherein the semirigid shaft is comprised of an external sheath of a plastic or fiber compound.

45. The guide-free dilator of claim 42, wherein the balloon has an ellipsoid or figure-8 configuration.

46. The guide-free dilator of claim 42, further comprising an inflation conduit emanating from the bottom of the rigid handle and terminating at the mounting balloon.

47. The guide-free dilator of claim 42, wherein the length of the mounting balloon is between about 1.0 cm and about 2.0 cm.

48. A medial ethmoid probe comprising:

i. a handle having a top portion and a bottom portion; and

ii. a shaft having a proximal segment and a distal segment, said proximal segment comprising a rigid material mounted on the top portion and the bottom portion of the handle and said distal segment comprising a semirigid material with a curved tip to engage an ostium in the ethmoid bulla, wherein the distal segment of the shaft curves to an angle ranging from about 30 degrees to about 60 degrees.

49. The medial ethmoid probe of claim 48, wherein the distal segment is wedge-shaped. 50. The medial ethmoid probe of claim 48, wherein the length of the distal segment ranges from about 0.7 cm to about 1.5 cm.

51. The medial ethmoid probe of claim 48, wherein the length of the distal segment is about 1.2 cm.

52. The medial ethmoid probe of claim 48, wherein the angle at the distal segment of the shaft at the bottom portion of the handle and at the top portion of the handle are identical.

53. The medial ethmoid probe of claim 48, wherein the angle at the distal segment of the shaft at the bottom portion of the handle and at the top portion of the handle are different. 54. The medial ethmoid probe of claim 48, wherein the angle at the distal segment of the shaft at the bottom portion is about 30 degrees and the angle of the distal segment of the shaft at the top portion of the handle is about 60 degrees.

55. The medial ethmoid probe of claims 48-54, wherein the distal segment is comprised of a material selected from the group consisting of silicone rubber, polyurethane, polyethylene terephthalate, polyethylene, polypropylene, polyvinyl chloride, polymethyl methacrylate, and polytetrafluoroethylene.

56. A probe capable of making a perforation in the wall of the ethmoid bulla comprising: i. a handle having a top portion and a bottom portion;

ii. an upper shaft mounted on the top portion of said handle;

iii. a lower shaft mounted on the bottom portion of said handle; and

iv. a perforator tip with a stop collar, said perforator tip mounted on the upper shaft, wherein the perforator tip has a sharp end for making a perforation in the wall of the ethmoid bulla.

57. The probe of claim 56, further comprising a dilator tip mounted at the on the lower shaft for dilating the perforation made in the wall of the ethmoid bulla.

58. The probe of claim 56, wherein the dilator tip is bluntly tapered at its distal end and rounded at its proximal end.

59. A drug insertion device comprising:

i. a rigid shaft containing a lumen, said rigid shaft angled distally at an angle between about 55 degrees and about 60 degrees;

ii. a piston slidedly connected to said lumen of said rigid shaft;

iii. a receptacle for holding a drug or drug delivery device, said receptacle mounted at the distal end of the rigid shaft; and

iv. a means for moving the piston through the lumen of the rigid shaft to the receptacle, causing release of the drug or drug delivery device.

60. The drug insertion device of claim 59, wherein the length of the receptacle is between about 1.0 cm and 2.0 cm.

61. The drug insertion device of claim 59, wherein the receptacle comprises flexible flanges which grip the drug or drug delivery device.

62. The drug insertion device of claim 59, wherein the receptacle comprises a sleeve which wholly encompasses the drug or drug delivery device.

63. A device for controlled delivery of a drug into a sinus comprising:

i. a drug containing matrix; and

ii. a degradable framework having a spine and a series of coplanar ribs protruding radially from the spine, the tips of the ribs protruding past the outer surface of the drug containing matrix, wherein the drug containing matrix degrades at a rate faster than the degradable framework.

64. A device for controlled delivery of a drug into a sinus comprising:

i. a drug containing matrix; and

ii. a degradable framework having a spine and an umbrella of ribs attached to the spine, said umbrella on the outside surface of the drug containing matrix; wherein the umbrella expands upon insertion into the sinus and wherein the drug containing matrix degrades at a rate faster than the degradable framework.