Ocular delivery systems and methods

• US 9,855,167 B2
• Filed: 10/04/2012
• Issued: 01/02/2018
• Est. Priority Date: 03/20/2012
• Status: Active Grant

• Current Assignee: Sight Sciences, Inc.
• Original Assignee: Sight Sciences, Inc.
• Inventors: Badawi, David Y., O'Keeffe, Daniel, Badawi, Paul
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): BUI, ANH T
• Application Number:
  US13/644,769
• Publication Number:
  US 20130253402A1
• Time in Patent Office: 1,916 Days
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery
• CPC Class Codes: A61F 9/00736 Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments A61F9/008 takes precedence
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

Described here are systems and methods for accessing Schlemm'"'"'s canal and for delivering an ocular device or fluid composition therein. The ocular devices may maintain the patency of Schlemm'"'"'s canal without substantially interfering with transmural fluid flow across the canal. The fluid composition may be a viscoelastic fluid that is delivered into the canal to facilitate drainage of aqueous humor by disrupting the canal and surrounding trabeculocanalicular tissues. Tools for disrupting these tissues and minimally invasive methods for treating medical conditions associated with elevated intraocular pressure, including glaucoma, are also described.

Claims

1. An implant-free method for treating conditions of the eye comprising:

advancing a conduit via the anterior chamber into Schlemm'"'"'s canal and along an arc of Schlemm'"'"'s canal by actuating a drive assembly in a first direction; and

delivering viscoelastic fluid through the conduit by actuating the drive assembly in a second direction opposite the first direction, wherein the viscoelastic fluid is delivered along the arc of Schlemm'"'"'s canal at a volume sufficient to disrupt the trabeculocanalicular tissues to reduce intraocular pressure.

2. The implant-free method of claim 1, wherein the volume of delivered viscoelastic fluid is between about 1 μ

l to about 50 μ

l.

3. The implant-free method of claim 2, wherein the volume of delivered viscoelastic fluid is between about 8 μ

l to 16 μ

l.

4. The implant-free method of claim 1, wherein the volume of viscoelastic fluid is delivered while advancing the conduit along the arc of Schlemm'"'"'s canal or while withdrawing the conduit from Schlemm'"'"'s canal.

5. The implant-free method of claim 1, wherein the conduit is advanced in both clockwise and counterclockwise directions in Schlemm'"'"'s canal.

6. The implant-free method of claim 1, wherein the conduit is advanced about a 360 degree arc of Schlemm'"'"'s canal.

7. The implant-free method of claim 1, wherein the conduit is advanced about a 180 degree arc of Schlemm'"'"'s canal.

8. The implant-free method of claim 1, wherein the conduit is advanced from a single access point in Schlemm'"'"'s canal.

9. The implant-free method of claim 5, wherein the conduit is advanced from a single access point in Schlemm'"'"'s canal.

10. The implant-free method of claim 1, wherein the conduit is advanced from a plurality of access points in Schlemm'"'"'s canal.

11. The implant-free method of claim 5, wherein the conduit is advanced from a plurality of access points in Schlemm'"'"'s canal.

12. The implant-free method of claim 1, wherein the volume of delivered viscoelastic fluid dilates Schlemm'"'"'s canal.

13. The implant-free method of claim 1, wherein the trabeculocanalicular tissues comprise at least a portion of the trabecular meshwork or juxtacanalicular tissue.

14. The implant-free method of claim 1, wherein the trabeculocanalicular tissues comprise collector channels.

15. The implant-free method of claim 1, wherein the conduit has an outer diameter between about 50 and about 500 microns.

16. The implant-free method of claim 15, wherein the conduit has a diameter of about 240 microns.

17. The implant-free method of claim 1, wherein the viscoelastic fluid comprises hyaluronic acid, chondroitin sulfate, cellulose, or salts, derivatives, or mixtures thereof.

18. The implant-free method of claim 17, wherein the viscoelastic fluid comprises sodium hyaluronate.

19. The implant-free method of claim 1, wherein the eye conditions are glaucoma, pre-glaucoma, or ocular hypertension.

72. The implant-free method of claim 1, wherein the volume of delivered viscoelastic fluid is at least about 50 μ

l.

74. The implant-free method of claim 1, wherein the viscoelastic fluid includes a drug.

75. The implant-free method of claim 74, wherein the drug comprises a prostaglandin, beta blocker, miotic, alpha adrenergic agonist, or carbonic anhydrase inhibitor.

76. The implant-free method of claim 74, wherein the drug comprises an anti-inflammatory.

77. The implant-free method of claim 74, wherein the drug comprises an antimetabolite.

78. The implant-free method of claim 74, wherein the drug comprises an anticoagulant or fibrinolytic compound.

20. A method for reducing intraocular pressure comprising:

a) advancing a cannula at least partially through the anterior chamber of the eye, wherein the cannula is connected to a unitary handle having a fluid reservoir located entirely therein;

b) entering Schlemm'"'"'s canal at a single access point using the cannula;

c) advancing a conduit along an arc of Schlemm'"'"'s canal, and

d) operating the handle to deliver a volume of fluid from the fluid reservoir through the conduit along the arc of Schlemm'"'"'s canal,

wherein the conduit is slidable within, and extendable from, the cannula, and wherein the volume of delivered fluid is sufficient to disrupt the structure of Schlemm'"'"'s canal and surrounding tissues to reduce intraocular pressure.

21. The method of claim 20, wherein the volume of delivered fluid is between about 1 μ

l and about 50 μ

l.

22. The method of claim 21, wherein the volume of delivered fluid is between about 8 μ

l and 16 μ

l.

23. The method of claim 20, wherein the conduit is advanced about a 360 degree arc of Schlemm'"'"'s canal from the single access point.

24. The method of claim 23, wherein the fluid is delivered along the 360 degree arc during withdrawal of the conduit from Schlemm'"'"'s canal.

25. The method of claim 20, wherein the conduit is advanced about a 180 degree arc of Schlemm'"'"'s canal from the single access point.

26. The method of claim 25, wherein the fluid is delivered along the 180 degree arc during withdrawal of the conduit from Schlemm'"'"'s canal.

27. The method of claim 20, wherein the conduit is advanced about a 180 degree arc of Schlemm'"'"'s canal in both clockwise and counterclockwise directions from the single access point.

28. The method of claim 27, wherein the fluid is delivered along both 180 degree arcs during withdrawal of the conduit from Schlemm'"'"'s canal.

29. The method of claim 20, wherein the conduit is advanced about a 90 degree arc of Schlemm'"'"'s canal from the single access point.

30. The method of claim 29, wherein the fluid is delivered along the 90 degree arc during withdrawal of the conduit from Schlemm'"'"'s canal.

31. The method of claim 20, wherein the fluid comprises hyaluronic acid, chondroitin sulfate, cellulose, or salts, derivatives, or mixtures thereof.

32. The method of claim 31, wherein the fluid comprises sodium hyaluronate.

33. The method of claim 20, wherein the conduit has an outer diameter of about 50 microns to about 500 microns.

34. The method of claim 33, wherein the conduit has an outer diameter of about 240 microns.

35. The method of claim 20, wherein the volume of delivered fluid is sufficient to increase the porosity or permeability of the trabecular meshwork or stretch the trabecular meshwork using the fluid.

36. The method of claim 20, wherein the volume of delivered fluid is sufficient to form microtears in the juxtacanalicular tissue using the fluid.

37. The method of claim 20, wherein the volume of delivered fluid is sufficient to dilate Schlemm'"'"'s canal using the fluid.

38. The method of claim 20, wherein the volume of delivered fluid is sufficient to remove septae from Schlemm'"'"'s canal using the fluid.

39. The method of claim 20, wherein the volume of delivered fluid is sufficient to dilate collector channels using the fluid.

40. The method of claim 20, wherein the reduction in intraocular pressure treats glaucoma, pre-glaucoma, or ocular hypertension.

41. The method of claim 20, further comprising delivering an implant within Schlemm'"'"'s canal to maintain patency of the canal.

42. The method of claim 41, wherein the implant comprises a helical support.

43. The method of claim 42, wherein the helical support comprises at least one fenestration.

44. The method of claim 20, further comprising delivering energy to modify the structure of Schlemm'"'"'s canal and surrounding tissues.

45. The method of claim 20, wherein the volume of fluid is continuously delivered through the conduit to disrupt the structure of Schlemm'"'"'s canal and surrounding tissues.

46. The method of claim 20, wherein the handle comprises a wheeled drive assembly.

47. The method of claim 46, wherein the wheeled drive assembly comprises a single rotatable component.

48. The method of claim 46, wherein the wheeled drive assembly comprises a plurality of rotatable components.

73. The method of claim 20, wherein the volume of delivered fluid is at least about 50 μ

l.

79. The method of claim 20, wherein the fluid comprises a drug.

80. The method of claim 79, wherein the drug comprises a prostaglandin, beta blocker, miotic, alpha adrenergic agonist, or carbonic anhydrase inhibitor.

81. The method of claim 79, wherein the drug comprises an anti-inflammatory.

82. The method of claim 79, wherein the drug comprises an antimetabolite.

83. The implant-free method of claim 79, wherein the drug comprises an anticoagulant or fibrinolytic compound.

84. The method of claim 79, wherein the drug is configured for sustained release.

49. A method for treating conditions of the eye comprising:

a) entering Schlemm'"'"'s canal via the anterior chamber using a conduit extendable from a unitary handle having a fluid reservoir located entirely therein;

b) advancing the conduit along an arc of Schlemm'"'"'s canal; and

c) delivering a volume of a viscoelastic fluid from the fluid reservoir through the conduit by decreasing the volume of the fluid reservoir,

wherein the volume of delivered viscoelastic fluid is sufficient to disrupt the structure of Schlemm'"'"'s canal and surrounding tissues to reduce intraocular pressure.

50. The method of claim 49, wherein the viscoelastic fluid is delivered about at least a 360 degree arc of Schlemm'"'"'s canal.

51. The method of claim 49, wherein the viscoelastic fluid is delivered about at least a 180 degree arc of Schlemm'"'"'s canal.

52. The method of claim 49, wherein the viscoelastic fluid is delivered about at least a 90 degree arc of Schlemm'"'"'s canal.

53. The method of claim 49, wherein the step of delivering occurs by advancing the conduit in both the clockwise and counterclockwise directions with the same handle.

54. The method of claim 49, wherein the viscoelastic fluid comprises hyaluronic acid, chondroitin sulfate, cellulose, or salts, derivatives, or mixtures thereof.

55. The method of claim 54, wherein the viscoelastic fluid comprises sodium hyaluronate.

56. The method of claim 49, wherein the conduit has an outer diameter between about 50 microns and about 500 microns.

57. The method of claim 56, wherein the conduit has an outer diameter of about 240 microns.

58. The method of claim 49, wherein the volume is sufficient to increase the porosity of the trabecular meshwork or stretch the trabecular meshwork using the viscoelastic fluid.

59. The method of claim 49, wherein the volume is sufficient to form microtears in the juxtacanalicular tissue using the viscoelastic fluid.

60. The method of claim 49, wherein the volume is sufficient to dilate Schlemm'"'"'s canal using the viscoelastic fluid.

61. The method of claim 49, wherein the volume is sufficient to remove septae from Schlemm'"'"'s canal using the viscoelastic fluid.

62. The method of claim 49, wherein the volume is sufficient to dilate collector channels using the viscoelastic fluid.

63. The method of claim 49, wherein the reduction in intraocular pressure treats glaucoma, pre-glaucoma, or ocular hypertension.

64. The method of claim 49, further comprising delivering an implant within Schlemm'"'"'s canal to maintain patency of the canal.

65. The method of claim 64, wherein the implant comprises a helical support.

66. The method of claim 65, wherein the helical support comprises at least one fenestration.

67. The method of claim 49, further comprising delivering energy to modify the structure of Schlemm'"'"'s canal and surrounding tissues.

68. The method of claim 49, wherein the volume of viscoelastic fluid is continuously delivered through the conduit to disrupt the structure of Schlemm'"'"'s canal and surrounding tissues.

69. The method of claim 49, wherein the handle comprises a wheeled drive assembly.

70. The method of claim 69, wherein the wheeled drive assembly comprises a single rotatable component.

71. The method of claim 69, wherein the wheeled drive assembly comprises a plurality of rotatable components.

85. The method of claim 49, wherein the viscoelastic fluid includes a drug.

86. The method of claim 85, wherein the drug comprises a prostaglandin, beta blocker, miotic, alpha adrenergic agonist, or carbonic anhydrase inhibitor.

87. The method of claim 85, wherein the drug comprises an anti-inflammatory.

88. The method of claim 85, wherein the drug comprises an antimetabolite.

89. The method of claim 85, wherein the drug comprises an anticoagulant or fibrinolytic compound.