Ocular delivery systems and methods

• US 10,179,066 B2
• Filed: 08/03/2015
• Issued: 01/15/2019
• 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): BOUCHELLE, LAURA A
• Application Number:
  US14/816,822
• Publication Number:
  US 20150335481A1
• Time in Patent Office: 1,261 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 a condition in an eye, comprising:

introducing a volume of viscoelastic fluid to Schlemm'"'"'s canal in an amount sufficient to disrupt trabeculocanalicular tissues through a flexible slidable conduit of a device, wherein the flexible slidable conduit comprises an atraumatic distal tip; and

using the flexible slidable conduit to disrupt trabeculocanalicular tissues during removal of the flexible slidable conduit from the eye.

2. The implant-free method of claim 1, wherein the volume of viscoelastic fluid disrupts collector channels.

3. The implant-free method of claim 2, wherein the flexible slidable conduit disrupts trabecular meshwork.

4. The implant-free method of claim 1, further comprising advancing the flexible slidable conduit via the anterior chamber into Schlemm'"'"'s canal along the arc of the canal.

5. The implant-free method of claim 4, wherein the device further comprises a fluid reservoir and a drive assembly, wherein the drive assembly causes advancement of the flexible slidable conduit and delivery of the volume of viscoelastic fluid.

6. The implant-free method of claim 5, wherein the volume of viscoelastic fluid corresponds to the length the flexible slidable conduit has been advanced along the arc.

7. The implant-free method of claim 4, further comprising retracting the flexible slidable conduit.

8. The implant-free method of claim 7, wherein the volume of viscoelastic fluid is delivered while retracting the flexible slidable conduit from Schlemm'"'"'s canal.

9. The implant-free method of claim 4, further comprising retracting the flexible slidable conduit and re-advancing the flexible slidable conduit.

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

11. The implant-free method of claim 4, wherein the flexible slidable conduit is advanced about a 180 degree arc of Schlemm'"'"'s canal.

12. The implant-free method of claim 11, further comprising retracting the flexible slidable conduit and re-advancing the flexible slidable conduit about a 180 degree arc of Schlemm'"'"'s canal.

13. The implant-free method of claim 12, wherein the flexible slidable conduit is advanced and re-advanced from a single access point in Schlemm'"'"'s canal, wherein one of the advancement and re-advancement is in a clockwise direction, and the other is in a counterclockwise direction.

14. The implant-free method of claim 4, wherein the flexible slidable conduit is advanced about a 90 degree arc of Schlemm'"'"'s canal.

15. The implant-free method of claim 4, wherein the flexible slidable conduit is advanced about 360 degrees of Schlemm'"'"'s canal.

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

l and about 20 μ

l.

17. The implant-free method of claim 16, wherein the volume of viscoelastic fluid is about 9 μ

l.

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

19. The implant-free method of claim 1, wherein the viscoelastic fluid comprises sodium hyaluronate.

20. The implant-free method of claim 1, wherein using the flexible slidable conduit to disrupt trabeculocanalicular tissues comprises cutting the trabecular meshwork.

21. The implant-free method of claim 20, wherein the flexible slidable conduit is configured such that it can be advanced into Schlemm'"'"'s canal without tearing the trabecular meshwork.

22. The implant-free method of claim 1, wherein the volume of viscoelastic fluid is about 20 μ

l.

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

24. The implant-free method of claim 1, wherein the volume of viscoelastic fluid disrupts the trabecular meshwork.