Ab externo intraocular shunt placement

• US 10,463,537 B2
• Filed: 06/02/2016
• Issued: 11/05/2019
• Est. Priority Date: 06/03/2015
• Status: Active Grant

• Current Assignee: AqueSys, Inc. (Abbvie Incorporated)
• Original Assignee: AqueSys, Inc. (Abbvie Incorporated)
• Inventors: Horvath, Christopher, Romoda, Laszlo O.
• Primary Examiner(s): Hollm, Jonathan A
• Application Number:
  US15/172,091
• Publication Number:
  US 20160354245A1
• Time in Patent Office: 1,251 Days
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61F 2009/0052 the instrument being supported on the patient's eye
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• 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

Placing an intraocular shunt ab externo into an eye can include inserting the shunt into the eye and either before and/or after insertion, ballooning a target outflow region of the eye to permit an outflow end of the shunt to be enveloped within the ballooned target outflow region. An injector docking device can optionally be used to guide insertion of the needle and shunt into the eye.

Claims

1. An ab externo method of placing an intraocular shunt into an eye, the method comprising the steps of:

determining an entry area below a corneal limbus of an eye and a target outflow region;

ballooning the target outflow region of the eye to form a bleb in the target outflow region;

inserting a hollow shaft into the eye at the entry area toward an anterior chamber of the eye, the shaft carrying an intraocular shunt therein;

positioning an inflow end of the shunt within the anterior chamber of the eye;

while maintaining the shunt inflow end in the anterior chamber, removing the shaft from the eye to release the shunt;

massaging the bleb in a direction away from the corneal limbus to reposition an outflow end of the shunt within the target outflow region; and

verifying placement of the outflow end of the shunt within the target outflow region.

2. The method of claim 1, wherein the ballooning comprises injecting a solution into the target outflow region of the eye.

3. The method of claim 1, wherein the ballooning is performed prior to inserting the hollow shaft into the eye.

4. The method of claim 3, further comprising ballooning the target outflow region after the shunt is released to reinflate the target outflow region.

5. The method of claim 1, wherein the ballooning is performed after removing the shaft from the eye.

6. The method of claim 1, further comprising:

positioning an injector docking device on the eye, the injector docking device comprising a needle port having a longitudinal axis; and

orienting the needle port longitudinal axis to intersect with the entry area and extend toward the anterior chamber.

7. The method of claim 6, wherein the injector docking device comprises a vacuum pocket on an eye-contacting surface thereof, the method further comprising applying suction between the injector docking device and the eye via the vacuum pocket to removably couple the injector docking device to the eye.

8. The method of claim 6, wherein the inserting the hollow shaft comprises inserting the hollow shaft into the needle port and advancing the shaft through the needle port into the eye via the entry area toward the anterior chamber.

9. The method of claim 6, wherein the injector docking device comprises a bleb pocket adjacent to the needle port, the method further comprising positioning the bleb pocket over the target outflow region.

10. The method of claim 6, wherein the injector docking device comprises an eye-contacting portion having a half-ring component, wherein the positioning comprises positioning the half-ring component against the eye.

11. The method of claim 10, wherein the positioning comprises positioning the half-ring component adjacent to the corneal limbus.

12. The method of claim 10, wherein the positioning comprises positioning the half-ring component in a location opposite the target outflow region along the corneal limbus.

13. The method of claim 10, wherein the eye-contacting portion further comprises an abutment portion, spaced apart from the half-ring component, the method further comprising positioning the abutment portion against the eye.

14. The method of claim 6, wherein the injector docking device comprises a ring-shaped structure having an eye-contacting surface configured to contact the eye, the method further comprising positioning the ring-shaped structure to place the eye-contacting surface against the eye.

15. The method of claim 6, wherein positioning the injector docking device comprises positioning prong tip portions of the injector docking device against the corneal limbus of the eye.

16. The method of claim 1, wherein the ballooning is performed using a syringe.

17. The method of claim 1, wherein the method is performed without using an injector docking device.

18. An ab externo method of placing an intraocular shunt into an eye, the method comprising the steps of:

ballooning a target outflow region within an eye to form a bleb in the target outflow region;

positioning an injector docking device, having a needle port, against the eye, the needle port being aligned with the target outflow region;

advancing a hollow shaft through the needle port with the hollow shaft aligned with the target outflow region, the hollow shaft housing an intraocular shunt therein;

advancing the hollow shaft into the eye toward an anterior chamber of the eye;

positioning an inflow end of the shunt within the anterior chamber of the eye;

verifying placement of an outflow end of the shunt within the target outflow region;

while maintaining a longitudinal position of the shunt relative to the eye, removing the shaft from the eye to release the shunt; and

massaging the bleb in a direction away from a corneal limbus of eye to reposition the outflow end of the shunt within the target outflow region.

19. The method of claim 18, wherein the positioning the injector docking device comprises aligning a longitudinal axis of the needle port with the target outflow region.

20. The method of claim 18, wherein the ballooning comprises injecting a solution into the target outflow region.

21. The method of claim 18, wherein the ballooning is performed prior to inserting the hollow shaft into the eye.

22. The method of claim 18, wherein the ballooning is performed after removing the shaft from the eye.

23. The method of claim 18, wherein the ballooning is performed using a syringe.

24. The method of claim 18, wherein the advancing the hollow shaft comprises advancing a sleeve of an inserter, separate from the injector docking device and including the hollow shaft, into the needle port to introduce the hollow shaft into the needle port in a direction toward the target outflow region.

25. The method of claim 18, wherein the injector docking device extends from an end portion of an inserter, the injector docking device and the inserter being formed from a single, continuous housing, the hollow shaft extending from the inserter through the needle port.