OCULAR DELIVERY SYSTEMS AND METHODS

• US 20130253437A1
• Filed: 10/04/2012
• Published: 09/26/2013
• 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
• Granted Patent: US 9,095,412 B2
• Time in Patent Office: Days
• US Class Current: 604/239
• 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 method for introducing viscoelastic fluid into Schlemm'"'"'s canal comprising:

advancing a conduit into Schlemm'"'"'s canal, wherein the conduit has been loaded with a volume of viscoelastic fluid; and

delivering the viscoelastic fluid into Schlemm'"'"'s canal, wherein delivering the volume of viscoelastic fluid is accomplished by a single-handed device used by a single operator.

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

l and about 8 μ

l.

3. The single-handed, single-operator method of claim 2, wherein the volume of delivered viscoelastic fluid is about 4 μ

l.

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

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

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

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

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

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

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

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

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

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

14. The single-handed, single-operator method of claim 1, wherein the trabeculocanalicular tissues comprise at least a portion of the trabecular meshwork.

15. The single-handed, single-operator method of claim 1, wherein the trabeculocanalicular tissues comprise collector channels.

16. The single-handed, single-operator method of claim 1, wherein the conduit has an outer diameter between about 150 and about 500 microns.

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

18. The single-handed, single-operator method of claim 1, wherein the single-handed device comprises a drive assembly for advancing for advancing the conduit.

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

20. The single-handed, single-operator method of claim 19, wherein the wheeled drive assembly comprises a single rotatable component.

21. The single-handed, single-operator method of claim 19, wherein the wheeled drive assembly comprises a plurality of rotatable components.

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

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

24. The single-handed, single-operator method of claim 1, wherein the eye conditions are glaucoma, pre-glaucoma, or ocular hypertension.