IP Library Granted Patent US 12,090,088
Granted Patent B2
US 12,090,088 · App. 17/523,168 · Granted Sep 17, 2024

Device for ocular access

Inventors: Amy Lee Hammack (Santa Clara, CA); Stanley R. Conston (San Carlos, CA); Ronald Yamamoto (San Francisco, CA)
Assignee: Clearside Biomedical, Inc.
A61F9/0017A61F9/00727A61F9/00736A61M5/46A61M5/486A61M2005/3103A61M2210/0612
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Quick Facts
Patent No.
US 12,090,088
App. No.
17/523,168
Granted
Sep 17, 2024
Kind
B2
Abstract

The present invention provides devices to access the suprachoroidal space or sub-retinal space in an eye via a minimally invasive transconjunctival approach. The devices may also be used after a partial dissection, for example after dissection of the outer scleral layer of the eye, and using the device within the dissection to access the suprachoroidal space or the sub-retinal space.

Claims (49)

1. A method of administering a therapeutic substance to a target region of an eye, the method comprising:

inserting a distal end portion of a puncture member into a first portion of the eye,

with the distal end portion of the puncture member disposed within the first portion, advancing, automatically in response to reduced resistance provided by the target region, an elongate member relative to the first portion of the eye to displace a second portion of the eye relative to the first portion to at least one of create or expand the target region; the target region being disposed between the first portion and the second portion, and the elongate member having a solid shape including a distal end configured to fit slidably within the puncture member;

with the target region created or expanded, withdrawing the elongate member relative to the first portion of the eye; and

conveying, through a lumen of the puncture member, the therapeutic substance into the target region.

2. The method of claim 1 , wherein the conveying occurs after the withdrawing is initiated.

3. The method of claim 1 , further comprising:

contacting an outer surface of the eye with a stopper associated with the puncture member to control a depth of entry of the puncture member during the inserting.

4. The method of claim 1 , wherein the inserting includes inserting the distal end portion of the puncture member tangentially relative to a natural curvature of the eye.

5. The method of claim 1 , wherein the elongate member is a wire.

6. The method of claim 5 , wherein the distal end of the wire is rounded.

7. The method of claim 1 , wherein the puncture member is a hollow needle.

8. The method of claim 1 , further comprising viewing, via an imaging system that is external to the eye, the elongate member extending beyond a terminal end of the puncture member and being in contact with the second portion, and the distal end portion of the puncture member within the target region.

9. The method of claim 1 , wherein the puncture member is associated with a syringe configured to convey the therapeutic substance through the lumen of the puncture member.

10. The method of claim 1 , wherein the elongate member has a blunt tip.

11. The method of claim 1 , wherein the first portion is a sclera of the eye, the second portion is a choroid of the eye, and the target region is a suprachoroidal space of the eye.

12. The method of claim 1 , wherein the target region is a subretinal space of the eye.

13. The method of claim 1 , wherein the advancing the elongate member includes advancing the elongate member through the lumen of the puncture member to displace the second portion of the eye.

14. The method of claim 1 , further comprising, prior to the inserting, dissecting an outer portion of the eye.

15. The method of claim 1 , wherein the first portion is a sclera of the eye, the second portion is a choroid of the eye, and the target region is a suprachoroidal space of the eye (SCS), the advancing the elongate member includes advancing the elongate member through the lumen of the puncture member to displace the choroid of the eye relative to the sclera to at least one of create or expand the SCS.

16. The method of claim 15 , wherein the elongate member has a blunt tip, and further comprising: viewing, via an imaging system that is external to the eye, the elongate member extending beyond a terminal end of the puncture member and being in contact with the choroid, and the distal end portion of the puncture member within the SCS.

17. The method of claim 1 , wherein the elongate member is operably coupled to an energy storage member, and the advancing includes the energy storage member exerting a force on the elongate member that is insufficient to advance the elongate member when the distal end of the elongate member is in the first portion but sufficient to advance the elongate member when the distal end of the elongate member is in the target region.

18. The method of claim 1 , wherein the elongate member is operably coupled to a spring, and the advancing includes the spring exerting a force on the elongate member that is insufficient to advance the elongate member when the distal end of the elongate member is in the first portion but sufficient to advance the elongate member when the distal end of the elongate member is in the target region.

19. The method of claim 1 , wherein the elongate member is substantially linear.

20. The method of claim 1 , wherein the elongate member has a substantially constant cross-sectional area.

21. A method of administering a therapeutic substance to a target region of an eye, the method comprising:

inserting a distal end portion of a puncture member into a first portion of the eye;

with the distal end portion of the puncture member disposed in the first portion of the eye, advancing an elongate member relative to the first portion of the eye to displace a second portion of the eye relative to the first portion to at least one of create or expand the target region; the elongate member being solid and having a distal end, the distal end of the elongate member configured to fit slidably within the puncture member, and the target region being disposed between the first portion and the second portion;

with the target region created or expanded, withdrawing the elongate member relative to the first portion of the eye; and

conveying the therapeutic substance into the target region.

22. The method of claim 21 , wherein the conveying includes conveying the therapeutic substance through a lumen defined by the puncture member.

23. The method of claim 22 , wherein the elongate member is flexible.

24. The method of claim 22 , wherein the first portion is a sclera of the eye, the second portion is a choroid of the eye, and the target region is a suprachoroidal space of the eye.

25. The method of claim 22 , wherein the advancing the elongate member includes advancing the elongate member through a lumen of the puncture member to displace the second portion of the eye.

26. The method of claim 21 , wherein the elongate member is slidably disposed within a lumen defined by the puncture member.

27. The method of claim 21 , further comprising:

contacting an outer surface of the eye with a stopper associated with the puncture member to control a depth of entry of the puncture member during the inserting.

28. The method of claim 21 , wherein the inserting includes inserting the distal end portion of the puncture member tangentially relative to a natural curvature of the eye.

29. The method of claim 21 , wherein the elongate member has an atraumatic distal end.

30. A method of administering a therapeutic substance to a target region of an eye, the method comprising:

inserting a distal end portion of a puncture member through a first portion of the eye and towards the target region;

as the distal end portion of the puncture member reaches the target region, advancing, with a force provided by a compressive element, an elongate member distally relative to and through a lumen defined by the puncture member to displace a second portion of the eye relative to the first portion to at least one of create or expand the target region; the target region being disposed between the first portion and the second portion, and the elongate member being solid and configured to slidably fit fully within the lumen; and

with the target region created or expanded, completely removing the elongate member from the first portion of the eye; and

conveying the therapeutic substance into the target region.

31. The method of claim 30 , wherein the inserting includes inserting the distal end portion of the puncture member tangentially relative to a natural curvature of the eye.

32. The method of claim 30 , wherein the elongate member has an atraumatic distal end.

33. The method of claim 30 , wherein the elongate member is flexible.

34. The method of claim 30 , wherein the first portion is a sclera of the eye, the second portion is a choroid of the eye, and the target region is a suprachoroidal space of the eye.

35. The method of claim 30 , wherein the conveying includes conveying the therapeutic substance through the lumen of the puncture member.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 16, 2022
From: ISCIENCE INTERVENTIONAL CORPORATION
To: CLEARSIDE BIOMEDICAL, INC.
Reel/Frame 059278/0626 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 16, 2022
From: HAMMACK, AMY LEE; CONSTON, STANLEY R.; YAMAMOTO, RONALD
To: ISCIENCE INTERVENTIONAL CORPORATION
Reel/Frame 059281/0099 →
CHANGE OF NAME Recorded Mar 16, 2022
From: ISCIENCE INTERVENTIONAL CORPORATION
To: ISCI HOLDINGS INC.
Reel/Frame 059369/0440 →
Continuity (6)
Continuation 17208235 · Mar 22, 2021
Continuation 15872206 · Jan 16, 2018
Continuation 14821310 · Aug 7, 2015
Continuation 13273775 · Oct 14, 2011
Provisional Application 61393741 · Oct 15, 2010
Related Publication 20220062041A1 · Mar 3, 2022