Ocular delivery systems and methods

• US 10,299,958 B2
• Filed: 03/31/2015
• Issued: 05/28/2019
• Est. Priority Date: 03/31/2015
• 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): Gray, Phillip A
• Application Number:
  US14/675,580
• Publication Number:
  US 20160287438A1
• Time in Patent Office: 1,519 Days
• Field of Search: 604521
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 33/14 Alkali metal chlorides; Alkaline earth metal chlorides
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants

Abstract

Described here are systems and methods for accessing Schlemm'"'"'s canal and for delivering an ocular device, tool, 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. Some systems described here may be configured to cut or tear the trabecular meshwork with the body of an elongate member located within Schlemm'"'"'s canal. Other 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 method for treating conditions of the eye using a device comprising a fluid assembly coupled to a linear gear via a linkage, a housing, a plunger, and an elongate member comprising a lumen, wherein the fluid assembly comprises a reservoir, and wherein the plunger comprises a lumen that fluidly connects the reservoir to the lumen of the elongate member, a proximal end that is located slidably within the reservoir, and a distal end that is fixedly attached to the linear gear, comprising:

advancing the elongate member into Schlemm'"'"'s canal by moving the linear gear and the fluid assembly together relative to the housing, wherein the linkage maintains a fixed distance between the fluid assembly and linear gear during advancement of the elongate member; and

retracting the elongate member and simultaneously delivering a fluid composition out of a distal opening of the lumen by moving the linear gear relative to the linkage, the fluid assembly, and the housing to decrease a distance between the fluid assembly and the linear gear, such that the plunger moves proximally within the reservoir to increase the length of the plunger within the reservoir and displace fluid composition within the reservoir.

2. The method of claim 1, wherein retracting the elongate member and delivering the fluid composition are both actuated by rotation of a wheel.

3. The method of claim 1, wherein the elongate member is advanced a first length around Schlemm'"'"'s canal, and wherein the fluid composition is delivered the same first length around Schlemm'"'"'s canal.

4. The method of claim 1, wherein the elongate member is advanced about 180 degrees around Schlemm'"'"'s canal in a first direction.

5. The method of claim 4, further comprising:

advancing the elongate member about 180 degrees around Schlemm'"'"'s canal in a second direction; and

retracting the elongate member and simultaneously delivering a fluid composition out of the distal opening of the lumen.

6. The method of claim 1, wherein the linear gear is coupled to a wheel, and wherein rotation of the wheel in a first direction moves the linear gear and the fluid assembly relative to the housing.

7. The method of claim 6, wherein rotation of the wheel in a second, opposite direction moves the linear gear relative to the linkage and the fluid assembly.

8. The method of claim 1, wherein the device further comprises a lock configured to restrict movement of the fluid assembly relative to the housing prior to use.

9. The method of claim 8, further comprising disengaging the lock to allow movement of the fluid assembly relative to the housing.

10. The method of claim 1, wherein the fluid assembly moves distally, but not proximally, relative to the housing.

11. The method of claim 1, wherein the fluid assembly moves distally relative to the housing during advancement of the elongate member and is fixed relative to the housing during retraction of the elongate member.

12. The method claim 11, wherein the housing comprises teeth that allow the fluid assembly to move distally relative to the housing during advancement of the elongate member and fix the fluid reservoir relative to the housing during retraction of the elongate member.

13. The method of claim 1, further comprising:

advancing the elongate member into Schlemm'"'"'s canal by moving the linear gear and the fluid assembly together relative to the housing a second time; and

retracting the elongate member and simultaneously delivering additional fluid composition out of the distal opening of the lumen by moving the linear gear relative to the linkage, the fluid assembly, and the housing a second time.

14. The method of claim 13, wherein advancing the elongate member into Schlemm'"'"'s canal moves the fluid assembly distally to a first position, and wherein re-advancing the elongate member into Schlemm'"'"'s canal moves the fluid assembly from the first position distally to a second position.

15. The method of claim 14, wherein advancing the elongate member into Schlemm'"'"'s canal moves the fluid assembly distally from an initial position to the first position, and the second position is a distal-most position of the fluid assembly, wherein the distance between the initial position and the second position determines a fixed cumulative amount of extension and retraction of the elongate member.

16. The method of claim 14, wherein the distance between the initial position and the second position determines a fixed cumulative volume of fluid composition for delivery.

17. The method of claim 14, wherein the fluid assembly remains in the first position during reaction of the elongate member.

18. The method of claim 14, wherein the fluid assembly has a maximum travel distance, and wherein moving the fluid assembly distally to the first position moves the fluid assembly half of its maximum travel distance.

19. The method of claim 4, wherein between about 2 microliters and about 9 microliters of the fluid composition are delivered to Schlemm'"'"'s canal.

20. The method of claim 19, wherein about 4.5 microliters of the fluid composition are delivered to Schlemm'"'"'s canal.

21. The method of claim 1, wherein the elongate member is advanced about 360 degrees around Schlemm'"'"'s canal.

22. The method of claim 4, wherein about 10 microliters of the fluid composition are delivered to Schlemm'"'"'s canal.

23. The method of claim 5, wherein about 20 microliters of the fluid composition are delivered to Schlemm'"'"'s canal in total.

24. The method of claim 1, further comprising tearing or cutting the trabecular meshwork.

25. The method of claim 24, wherein the trabecular meshwork is torn by the elongate member.

26. The method of claim 25, wherein the trabecular meshwork is torn by the body of the elongate member.