Devices, systems and methods useable for treating frontal sinusitis

• US 20070129751A1
• Filed: 02/16/2006
• Published: 06/07/2007
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Chang, John, Makower, Joshua, Muni, Ketan, Facteau, William, Fernandez, Carlos
• Granted Patent: US 8,894,614 B2
• Time in Patent Office: Days
• US Class Current: 606/196
• 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: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00601 Cutting
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2029/025 characterised by the guiding element
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 31/005 for contrast media

Abstract

Devices, systems and methods wherein a dilator, such as a balloon or other expandable member, is positionable within the frontal sinus ostium and adjacent frontal recess and useable to dilate the frontal sinus ostium and substantially all of the frontal sinus recess without requiring repositioning and repeated re-expansion of the dilator. One balloon catheter device of the invention comprises a catheter body that is less than about 50 cm in length (and in some embodiments less than 25 cm in length and a semi-compliant or non-compliant balloon on the catheter body. The balloon may have a working length of about 12 mm to about 30 mm and a width at its widest point when fully inflated of about 2 mm to about 7 mm. Such balloon may be constructed to withstand inflation pressures of about 12 atmospheres. In some embodiments, the dilator is advanced through or over a guide (e.g., guidewire or guide catheter) that has a preformed shape.

Claims

1. A method for improving outflow through a frontal sinus ostium and adjacent frontal recess in a human or animal subject, said method comprising the steps of:

A) providing a dilator that has a collapsed configuration and an expanded configuration, said dilator being of a length that is approximately as long as or longer than the length of the frontal sinus ostium and frontal recess combined;

B) positioning the dilator such that it occupies the frontal sinus ostium and substantially all of the frontal outflow tract while in its collapsed configuration; and

C) causing the dilator to expand to its expanded configuration, thereby dilating the frontal sinus ostium and substantially all of the frontal outflow tract.

2. A method according to claim 1 wherein the entire frontal recess becomes dilated.

3. A method according to claim 2 wherein a single expansion of the dilator is performed in Step C.

4. A method according to claim 2 wherein more than one expansion of the dilator is performed in Step C without substantially changing the longitudinal position of the dilator.

5. A method according to claim 1 wherein Step C results in at least some breakage or movement of bone adjacent to the ostium.

6. A method according to claim 1 wherein Step C results in at least one effect selected from the group consisting of:

i) breakage, cracking or fracture of bone, ii) movement of bone and iii) compression, reconfiguration or remodeling of at least one air cell located adjacent to the frontal recess.

7. A method according to claim 1 wherein the method is performed without removal, cutting or ablation of tissue.

8. A method according to claim 1 wherein the method is performed in combination with a surgical procedure that results in some removal, cutting or ablation of tissue.

9. A method according to claim 8 wherein the method is performed in combination with a FESS procedure.

10. A method according to claim 1 wherein the dilator provided in Step A has a length of about 12 mm to about 24 mm.

11. A method according to claim 10 wherein the subject is fully grown human and the dilator has a length of about 24 mm.

12. A method according to claim 10 or 11 wherein the subject is a fully grown human and the dilator expands to a diameter of from about 5 mm to about 7 mm.

13. A method according to claim 10 wherein the subject is a human child between the ages of about 14 to about 17 and the dilator has a length of about 24 mm.

14. A method according to claim 10 or 13 wherein the subject is a human child between the ages of about 14 to about 17 and the dilator expands to a diameter of about 4 to about 7 mm.

15. A method according to claim 10 wherein the subject is a human child between the ages of about 10 to about 14 and the dilator has a length of about 21 mm.

16. A method according to claim 10 or 15 wherein the subject is a human child between the ages of about 10 to about 14 and the dilator expands to a diameter of about 3 mm to about 6 mm.

17. A method according to claim 10 wherein the subject is a human child between the ages of about 6 to about 10 and the dilator has a length of about 18 mm.

18. A method according to claim 10 or 17 wherein the subject is a human child between the ages of about 6 to about 10 and the dilator expands to a diameter of about 2 mm to about 5 mm.

19. A method according to claim 10 wherein the subject is a human child under about 6 years of age and the dilator has a length of about 15 mm.

20. A method according to claim 10 or 19 wherein the subject is a human child under about 6 years of age and the dilator expands to a diameter of about 2 mm to about 4 mm.

21. A method according to claim 1 wherein the dilator is trans-nasally positioned.

22. A method according to claim 21 wherein Step B comprises inserting a catheter having the dilator mounted thereon through one of the subject'"'"'s nostrils and advancing the catheter to a position where the dilator occupies substantially all of one of the subject'"'"'s frontal outflow tracts.

23. A method according to claim 22 wherein Step B further comprises inserting the catheter through the other of the subject'"'"'s nostrils and advancing the catheter to a position where the dilator occupies substantially all of the other of the subject'"'"'s frontal outflow tracts.

24. A method according to claim 1 wherein the dilator has a guidewire lumen and wherein Step B comprises inserting a guidewire to a position within or near the frontal sinus, frontal sinus ostium or frontal recess and advancing the dilator over the guidewire.

25. A method according to claim 1 or 24 wherein the dilator is advanceable through a tubular guide and wherein Step B comprises inserting a tubular guide to a position within or near the frontal sinus, frontal sinus ostium or frontal recess and advancing the dilator through the tubular guide.

26. A method according to claim 25 wherein the dilator is additionally advanceable over a guidewire and wherein Step B comprises positioning the tubular guide such that its distal end is near or within the frontal recess, inserting a guidewire into or through the frontal recess and thereafter advancing the dilator over the guidewire and through the tubular guide to the position where the dilator is within the frontal sinus ostium and at least substantially all of the frontal recess.

27. A method according to claim 26 wherein the distal end of the tubular guide is initially inserted within the frontal recess and wherein the method further comprises the step of pulling the tubular guide back prior to expansion of the dilator.

28. A method according to claim 1 further comprising the step of inserting an endoscope into the nose and using the endoscope to view at least a portion of the method.

29. A method according to claim 28 wherein an endoscopically visible marker is associated with a location on the dilator and wherein the endoscope is used to view that marker thereby facilitating correct positioning of the dilator prior to expansion of the dilator.

30. A method according to claim 29 further comprising the step of placing a therapeutic or diagnostic substance delivering implant within the frontal sinus, frontal sinus ostium or frontal recess.

31. A system useable for dilating a frontal sinus ostium and at least substantially all of an adjacent frontal recess in a human or animal subject, said device comprising:

a dilator having a length that is at least long enough to extend through the frontal sinus ostium and substantially all of the frontal recess; and

a guide having a distal end and a substantially fixed shape, said guide being insertable through one of the subject'"'"'s nostrils and advanceable to a position where the distal end of the guide is adjacent to or within the frontal recess;

the dilator being advanceable over or through the guide to a position where the dilator is positioned within the frontal sinus ostium and frontal recess such that subsequent expansion of the dilator will result in dilation of the frontal sinus ostium and substantially all of the adjacent frontal recess.

32. A system according to claim 31 wherein the guide comprises a tubular guide of substantially fixed shape having a lumen and a distal end, the lumen of said tubular guide being sized to allow the dilator to pass therethough.

33. A system according to claim 31 wherein the guide comprises a guidewire having at least one region of substantially fixed shape and wherein the dilator has a guidewire lumen sized to receive said guidewire such that the dilator may be advanced over the guidewire.

34. A system according to claim 31 wherein the substantially fixed shape of the guide comprises a curve located within 2 mm of its distal end.

35. A system according to claim 34 wherein the curve is between 30 degrees and 110 degrees.

36. A system according to claim 34 wherein the curve is approximately 70 degrees.

37. A system according to claim 31 wherein the dilator comprises a balloon.

38. A system according to claim 37 wherein the balloon is non-compliant.

39. A system according to claim 37 wherein the balloon is semi-compliant.

40. A system according to claim 37 wherein the balloon is formed substantially of polyethylene terephthalate having a calculated radial tensile strength of greater than about 25,000 psi.

41. A system according to any of claims 37, 38 or 39 wherein the balloon is at least partially coated with a protective coating.

42. A system according to claim 41 wherein the coating comprises a matrix polymer and a reinforcing agent.

43. A system according to claim 42 wherein the matrix polymer is selected from the group consisting of urethanes, acrylics, and epoxies.

44. A system according to claim 42 wherein the reinforcing agent is lamellar, platelet, or fiber-like in structure and has a higher surface hardness than the surface hardness of the material of which the balloon is formed.

45. A system according to claim 41 wherein the coating has a thickness in the range of about 0.1 mil to about 3 mil.

46. A system according to claim 41 wherein the coating has a thickness in the range of about 0.5 mil to about 2 mil.

47. A system according to claim 41 wherein the coating further comprises a crosslinking agent.

48. A system according to claim 47 wherein the crosslinking agent is selected from the group consisting of aziridine, carbodiimides, urea formaldehyde, melamine formaldehyde condensates, epoxies, isocyanates, titanates, zircoaluminates, zinc crosslinkers, and silanes.

49. A system according to claim 42 wherein the reinforcing agent comprises a micaceous pigment.

50. A system according to claim 42 wherein the reinforcing agent comprises glass fiber.

51. A system according to claim 42 wherein the reinforcing agent is selected from the group consisting of lamellar platelet, flake pigments, tungsten powder, and fibers.

52. A system according to claim 42 wherein the coating further comprises an additive selected from the group consisting of radio pacifiers, anti-slip additives, anti-mar additives, and antimicrobial agents, and therapeutic agents.

53. A system according to claim 42 wherein the reinforcing agent is aligned in a direction parallel to the underlying surface of the balloon.

54. A system according to claim 42 wherein the reinforcing agent is present in the coating in an amount in the range of about 10% to about 50% by weight of solids.

55. A system according to claim 42 wherein the coating further comprises a therapeutic substance.

56. A system according to claim 41 wherein the balloon further comprises a primer layer disposed between the balloon surface and the protective coating.

57. A system according to claim 31 wherein the guide has a distal portion and a proximal portion, the distal portion being more flexible than the proximal portion.

58. A system according to claim 31 wherein at least a portion of the guide is malleable such that it may be bent to said substantially fixed shape prior to insertion into the subject'"'"'s body.

59. A system according to claim 31 wherein at least a portion of the guide is formed to said substantially fixed shape at the time of manufacture and is sufficiently rigid to maintain said substantially fixed shape until and during use.

60. A balloon catheter device comprising:

a catheter body having a proximal end, a distal end and a length of less than about 50 cm;

a semi-compliant or non-compliant balloon mounted on the catheter body, said balloon having a working length of about 12 mm to about 30 mm and a width at its widest point when fully inflated of about 2 mm to about 7 mm;

said balloon being constructed to withstand inflation pressures of about 12 atmospheres.

61. A device according to claim 60 wherein the balloon is non-compliant.

62. A device according to claim 60 wherein the balloon is semi-compliant.

63. A device according to claim 60 wherein the balloon is formed substantially of polyethylene terephthalate having a calculated radial tensile strength of greater than about 25,000 psi.

64. A device according to any of claims 60 wherein the balloon is at least partially coated with a protective coating.

65. A device according to claim 64 wherein the coating comprises a matrix polymer and a reinforcing agent.

66. A device according to claim 65 wherein the matrix polymer is selected from the group consisting of urethanes, acrylics, and epoxies.

67. A device according to claim 65 wherein the reinforcing agent is lamellar, platelet, or fiber-like in structure and has a higher surface hardness than the surface hardness of the material of which the balloon is formed.

68. A device according to claim 64 wherein the coating has a thickness in the range of about 0.1 mil to about 3 mil.

69. A device according to claim 64 wherein the coating has a thickness in the range of about 0.5 mil to about 2 mil.

70. A device according to claim 65 wherein the coating further comprises a crosslinking agent.

71. A device according to claim 70 wherein the crosslinking agent is selected from the group consisting of aziridine, carbodiimides, urea formaldehyde, melamine formaldehyde condensates, epoxies, isocyanates, titanates, zircoaluminates, zinc crosslinkers, and silanes.

72. A device according to claim 65 wherein the reinforcing agent comprises a micaceous pigment.

73. A device according to claim 65 wherein the reinforcing agent comprises glass fiber.

74. A device according to claim 65 wherein the reinforcing agent is selected from the group consisting of lamellar platelet, flake pigments, tungsten powder, and fibers.

75. A device according to claim 65 wherein the coating further comprises an additive selected from the group consisting of radio pacifiers, anti-slip additives, anti-mar additives, and antimicrobial agents, and therapeutic agents.

76. A device according to claim 65 wherein the reinforcing agent is aligned in a direction parallel to the underlying surface of the balloon.

77. A device according to claim 65 wherein the reinforcing agent is present in the coating in an amount in the range of about 10% to about 50% by weight of solids.

78. A device according to claim 65 wherein the coating further comprises a therapeutic substance.

79. A device according to claim 64 wherein the balloon further comprises a primer layer disposed between the balloon surface and the protective coating.

80. A device according to claim 60 further comprising a guidewire lumen extending though at least a portion of the catheter body.

81. A device according to claim 80 wherein the guidewire lumen extends through the entire length of the catheter body.

82. A device according to claim 80 wherein a guidewire port is formed in the catheter body at a location between its proximal end and its distal end and the guidewire lumen extends from that guidewire port through the distal end of the catheter body.

83. A device according to claim 60 further comprising a fixed guidewire extending from the distal end of the catheter body.

84. A device according to claim 60 wherein the catheter body has a length of less than about 25 cm.