Ocular delivery systems and methods

• US 9,095,412 B2
• Filed: 10/04/2012
• Issued: 08/04/2015
• 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:
  US13/644,748
• Publication Number:
  US 20130253437A1
• Time in Patent Office: 1,034 Days
• Field of Search: 604/521, 623/6.12, 623/6.13
• US Class Current: 1/1
• 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. A single-handed, single-operator, ab-interno method for introducing viscoelastic fluid into Schlemm'"'"'s canal comprising:

advancing a cannula at least partially through the anterior chamber of the eye and into Schlemm'"'"'s canal, wherein the cannula is coupled to a handle of a single-handed, single-operator controlled device, a portion of the handle defining a fluid reservoir and comprising a drive assembly configured to advance a flexible slidable conduit from the cannula and to deliver a volume of viscoelastic fluid;

advancing the flexible slidable conduit from the cannula into Schlemm'"'"'s canal along an arc of the canal; and

delivering the volume of viscoelastic fluid from the reservoir into Schlemm'"'"'s canal through the flexible slidable conduit, wherein the volume of viscoelastic fluid delivered corresponds to the length the flexible conduit has been advanced along the arc.

2. The single-handed, single-operator, ab-interno method of claim 1, wherein the volume of delivered viscoelastic fluid is between about 2 μ

l and about 20 μ

l.

3. The single-handed, single-operator, ab-interno method of claim 2, wherein the volume of delivered viscoelastic fluid is about 9 μ

l.

4. The single-handed, single-operator, ab-interno method of claim 1, wherein the volume of viscoelastic fluid is delivered while withdrawing the flexible slidable conduit from Schlemm'"'"'s canal.

5. The single-handed, single-operator, ab-interno method of claim 1, wherein the reservoir is loaded with the viscoelastic fluid immediately prior to advancing the flexible slidable conduit into Schlemm'"'"'s canal.

6. The single-handed, single-operator, ab-interno method of claim 1, wherein the flexible slidable conduit is advanced in both clockwise and counterclockwise directions in Schlemm'"'"'s canal.

7. The single-handed, single-operator, ab-intero method of claim 6, wherein the flexible slidable conduit is advanced from a single access point in Schlemm'"'"'s canal.

8. The single-handed, single-operator, ab-interno method of claim 6, wherein the flexible slidable conduit is advanced from a plurality of access points in Schlemm'"'"'s canal.

9. The single-handed, single-operator, ab-interno method of claim 1, wherein the flexible slidable conduit is advanced about a 360 degree arc of Schlemm'"'"' s canal.

10. The single-handed, single-operator, ab-interno method of claim 1, wherein the flexible slidable conduit is advanced about a 180 degree arc of Schlemm'"'"' s canal.

11. The single-handed, single-operator, ab-interno method of claim 1, wherein the flexible slidable conduit is advanced from a single access point in Schlemm'"'"'s canal.

12. The single-handed, single-operator, ab-interno method of claim 1, wherein the flexible slidable conduit is advanced from a plurality of access points in Schlemm'"'"'s canal.

13. The single-handed, single-operator, ab-interno method of claim 1, wherein the delivery of the volume of viscoelastic fluid dilates Schlemm'"'"'s canal.

14. The single-handed, single-operator, ab-interno method of claim 1, wherein the delivery of the volume of viscoelastic fluid disrupts trabeculocanalicular tissues.

15. The single-handed, single-operator, ab-interno method of claim 1, wherein the delivery of the volume of viscoelastic fluid dilates collector channels.

16. The single-handed, single-operator, ab-interno method of claim 1, wherein the flexible slidable conduit has an outer diameter between about 50 and about 500 microns.

17. The single-handed, single-operator, ab-interno method of claim 16, wherein the flexible slidable conduit has a diameter of about 240 microns.

18. The single-handed, single-operator ab-interno method of claim 1, wherein the drive assembly comprises a wheeled drive assembly.

19. The single-handed, single-operator, ab-interno method of claim 18, wherein wheeled drive assembly comprises a single rotatable component.

20. The single-handed, single-operator, ab-interno method of claim 18, wherein the wheeled drive assembly comprises a plurality of rotatable components.

21. The single-handed, single-operator, ab-interno method of claim 1, wherein the viscoelastic fluid comprises hyaluronic acid, chondroitin sulfate, cellulose, or salts, derivatives, or mixtures thereof.

22. The single-handed, single-operator, ab-interno method of claim 21, wherein the viscoelastic fluid comprises sodium hyaluronate.

23. The single-handed, single-operator, ab-interno method of claim 1, wherein the delivered viscoelastic fluid is used to treat an eye condition.

24. The single-handed, single-operator, ab-interno method of claim 23, wherein the eye condition is glaucoma, pre-glaucoma, or ocular hypertension.