OCULAR DELIVERY SYSTEMS AND METHODS

• US 20160287438A1
• Filed: 03/31/2015
• Published: 10/06/2016
• 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
• Granted Patent: US 10,299,958 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 system for introducing a fluid composition into Schlemm'"'"'s canal, comprising:

a housing;

a cannula attached to the distal end of the housing and comprising a distal tip;

a flexible elongate member comprising a lumen and a distal end, wherein the distal end is slidable within the cannula between a retracted position and an extended position, wherein the distal end is within the cannula in the retracted position and distal to the distal tip of the cannula in the extended position;

a reservoir comprising a fluid composition, wherein the reservoir is fluidly connected to the lumen of the flexible elongate member; and

a drive assembly configured to simultaneously move the flexible elongate member from the extended position to the retracted position and deliver the fluid composition from the reservoir through the lumen of the flexible elongate member.

2. The system of claim 1, further comprising a lock configured to resist movement of the reservoir relative to the housing.

3. The system of claim 1, wherein the drive assembly comprises a linear gear, and wherein translation of the linear gear in a first direction moves the flexible elongate member toward the retracted configuration and delivers the fluid composition from the reservoir through the lumen of the flexible elongate member.

4. The system of claim 3, wherein translation of the linear gear in a second direction moves the flexible polymeric elongate member toward the extended configuration.

5. The system of claim 3, wherein drive assembly further comprises a rotatable component, wherein rotation of the rotatable component causes translations of the linear gear.

6. The system of claim 3, wherein a volume of fluid composition delivered from the reservoir corresponds to a distance of translation of the linear gear in the first direction.

7. The system of claim 4, wherein a volume of fluid composition delivered from the reservoir corresponds to a distance of movement of the flexible elongate member toward the extended configuration.

8. The system of claim 1, wherein the device is configured to prevent movement of the flexible polymeric elongate member toward the extended position after the flexible elongate member has been retracted a fixed cumulative distance.

9. The system of claim 8, wherein the fixed cumulative distance is about 40 mm.

10. A system for introducing a fluid composition into Schlemm'"'"'s canal, comprising:

a housing;

a reservoir holding the fluid composition located within the housing; and

a flexible polymeric elongate member comprising a lumen fluidly connected to the reservoir, and

a drive assembly configured to causing a volume of fluid composition to be delivered from the reservoir to Schlemm'"'"'s canal via the lumen of the flexible polymeric elongate member, and to cause the flexible polymeric elongate member to translate by a distance relative to the housing,

wherein the volume of fluid composition delivered is fixed relative to the distance translated by the flexible polymeric elongate member.

11. The system of claim 10, wherein the drive assembly comprises a rotatable wheel, and wherein the volume of fluid composition delivered and the distance translated by the flexible polymeric elongate member are fixed relative to an amount of rotation of the wheel.

12. A method for treating conditions of the eye, comprising:

advancing an elongate member into Schlemm'"'"'s canal, wherein the elongate member comprises a lumen having a distal opening at a distal tip of the elongate member; and

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

13. The method of claim 12, wherein retracting the elongate member and delivering the fluid composition are both actuated by rotation of a wheel.

14. The method of claim 12, 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.

15. The method of claim 12, wherein the elongate member is advanced about 180 degrees around Schlemm'"'"'s canal in a first direction.

16. The method of claim 15, 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.

17. A method for delivering a fluid composition into Schlemm'"'"'s canal using a device comprising a reservoir, a plunger comprising a lumen and a proximal end, and a flexible elongate member comprising a lumen, wherein the reservoir is fluidly connected to the lumen of the flexible elongate member via the lumen of the plunger, and wherein the proximal end of the plunger is located slidably within the reservoir, comprising:

moving the proximal end of the plunger proximally within the reservoir from an extended position to a depressed position within the reservoir, such that the plunger displaces fluid composition from the reservoir,

wherein the displaced fluid composition travels through the lumen of the plunger to the lumen of the flexible elongate member.

18. A method for treating conditions of the eye using a delivery system comprising a housing, a drive mechanism comprising a first wheel having a portion extending out of a first side of the housing and a second wheel having a portion extending out of a second side of the housing, a cannula extending from a distal end of the housing, and a slidable elongate member located slidably within the cannula, comprising:

piercing trabecular meshwork of the eye with the cannula;

proximally moving the portion of the first wheel extending out of the first side of the housing to extend the slidable elongate member distally from a retracted position within the cannula such that it advances around Schlemm'"'"'s canal in a first direction; and

distally moving the portion of the first wheel extending out of the first side of the housing to retract the slidable elongate member proximally back to the retracted position.

19. The method of claim 18, wherein distally moving the portion of the first wheel extending out of the first side of the housing also causes a fluid composition to be delivered into Schlemm'"'"'s canal.

20. The method of claim 18, further comprising:

proximally moving the portion of the second wheel extending out of the second side of the housing to extend the slidable elongate member distally from the retracted position within the cannula such that it advances around Schlemm'"'"'s canal in a second direction; and

distally moving the portion of the second wheel extending out of the second side of the housing to cause the slidable elongate member to retract proximally back to the retracted position.

21-56. -56. (canceled)