Ocular delivery systems and methods

• US 9,216,109 B2
• Filed: 10/04/2012
• Issued: 12/22/2015
• 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): VU, QUYNH-NHU HOANG
• Application Number:
  US13/644,758
• Publication Number:
  US 20130253438A1
• Time in Patent Office: 1,174 Days
• Field of Search: 604/19, 604/21, 604/95.01, 604/131, 604154-156
• 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 controlled device for delivering fluids comprising:

a cannula;

a flexible polymeric conduit slidably disposed within, and advanceable distally from, the cannula; and

a handle coupled to the cannula, wherein a portion of the handle defines a fluid reservoir, and wherein the flexible polymeric conduit comprises a lumen in fluid communication with the reservoir, and wherein the device is configured to deliver a fluid through the lumen of the flexible polymeric conduit upon movement of the flexible polymeric conduit.

2. The single-handed, single-operator controlled device of claim 1, wherein the flexible polymeric conduit has a diameter between about 100 microns and about 500 microns.

3. The single-handed, single-operator controlled device of claim 2, wherein the flexible polymeric conduit has a diameter of about 240 microns.

4. The single-handed, single-operator controlled device of claim 1, wherein the conduit comprises a plurality of openings spaced along at least a portion of its axial length.

5. The single-handed, single-operator controlled device of claim 1, wherein a distal end of the conduit comprises a cut out configured as a half tube.

6. The single-handed, single-operator controlled device of claim 1, wherein the handle comprises a drive assembly capable of pressurizing the fluid to deliver the fluid from the fluid reservoir through the lumen of the flexible polymeric conduit.

7. The single-handed, single-operator controlled device of claim 6, wherein the drive assembly comprises a wheeled drive assembly.

8. The single-handed, single-operator controlled device of claim 7, wherein the wheeled drive assembly comprises a single rotatable component.

9. The single-handed, single-operator controlled device of claim 7, wherein the wheeled drive assembly comprises a plurality of rotatable components.

10. The single-handed, single-operator controlled device of claim 1, wherein the handle comprises a preloaded reservoir, the preloaded reservoir comprising a viscoelastic fluid.

11. The single-handed, single-operator controlled device of claim 10, wherein the viscoelastic fluid comprises hyaluronic acid, chondroitin sulfate, cellulose, or salts, derivatives, or mixtures thereof.

12. The single-handed, single-operator controlled device of claim 11, wherein the viscoelastic fluid comprises sodium hyaluronate.

13. The single-handed, single-operator controlled device of claim 1, wherein the fluid reservoir comprises a viscoelastic fluid.

14. The single-handed, single-operator controlled device of claim 13, wherein the viscoelastic fluid comprises hyaluronic acid, chondroitin sulfate, cellulose, or salts, derivatives, or mixtures thereof.

15. The single-handed, single-operator controlled device of claim 14, wherein the viscoelastic fluid comprises sodium hyaluronate.

16. The single-handed, single-operator controlled device of claim 2, wherein the flexible polymeric conduit has a diameter between about 100 microns and about 200 microns.

17. The single-handed, single-operator controlled device of claim 1, wherein movement of the flexible polymeric conduit comprises advancement of the flexible polymeric conduit.

18. The single-handed, single-operator controlled device of claim 1, wherein movement of the flexible polymeric conduit comprises retraction of the flexible polymeric conduit.

19. The single-handed, single-operator controlled device of claim 1, wherein the fluid comprises a drug.

20. The single-handed, single-operator controlled device of claim 1, wherein the fluid comprises a drug combined with a viscoelastic fluid.