OCULAR IMPLANT APPLIER AND METHODS OF USE

• US 20110112546A1
• Filed: 07/29/2010
• Published: 05/12/2011
• Est. Priority Date: 07/29/2009
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Transcend Medical Incorporated (Alcon Incorporated)
• Inventors: Garcia, Jose, John, Steven, Lilly, Richard S., Juan, Eugene de JR., Silvestrini, Thomas A.
• Granted Patent: US 8,535,333 B2
• Time in Patent Office: Days
• US Class Current: 606/108
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/0026 Ophthalmic product dispenser attachments to facilitate positioning near the eye
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

Described herein is a delivery device and methods for delivering an ocular implant into an eye. The delivery device includes a proximal handle portion; a distal delivery portion coupled to a distal end of the handle portion and configured to releasably hold an ocular implant and includes a sheath positioned axially over a guidewire; and a metering system configured to provide visual guidance regarding depth of advancement of an implant positioned on the guidewire into an anatomic region of the eye. Also disclosed is a device and method for loading an implant onto the delivery device.

Claims

1. A delivery device for delivering an ocular implant into an eye, the delivery device comprising:

a proximal handle portion;

a distal delivery portion coupled to a distal end of the handle portion and configured to releasably hold an ocular implant, the delivery portion comprising a sheath positioned axially over a guidewire; and

a metering system configured to provide visual guidance regarding depth of advancement of an implant positioned on the guidewire into an anatomic region of the eye.

2. A delivery device as in claim 1, wherein the anatomic region of the eye is the suprachoroidal space.

3. A delivery device as in claim 1, wherein the metering system comprises a first series of graduated markings on the guidewire.

4. A delivery system as in claim 3, wherein the metering system further comprises a second series of graduated markings on the sheath.

5. A delivery system as in claim 4, wherein the first series of graduated markings correlate to the second series of graduated markings.

6. A delivery system as in claim 1, wherein the metering system comprises one or more graduated markings on a surface of the distal delivery portion.

7. A delivery system as in claim 6, further comprising an additional blank band distal to the one or more graduated markings.

8. A delivery system as in claim 1, wherein the metering system comprises two or more unique bands of color.

9. A delivery device as in claim 1, wherein the sheath is in a fixed position relative to the handle portion.

10. A delivery device as in claim 1, further comprising an elongate plate positioned adjacent the guidewire.

11. A delivery system as in claim 10, wherein the elongate plate is adapted to move, protect, or deflect tissue during delivery of the implant into the eye.

12. A delivery system as in claim 11, wherein the elongate plate further comprises one or more graduated markings.

13. A method of using a delivery system for implantation of a device into an eye, the method comprising:

mounting an implant on a delivery device comprising a guidewire having a sheath coupled to the guidewire, wherein the guidewire comprises a first metering system at a distal end of the guidewire and the sheath comprises a second metering system at a distal end of the sheath, the first and second metering systems having corresponding graduated markings;

inserting the implant on the delivery device into an anterior chamber through an incision in a cornea;

advancing the implant on the delivery device through a transparent zone of the anterior chamber toward an opaque zone of the anterior chamber;

seating a distal end of the guidewire at eye tissue where resistance is felt;

reading through the transparent zone a first graduated marking of the first metering system, wherein the first graduated marking is aligned with an edge between the transparent zone and the opaque zone;

advancing the implant on the guidewire into the eye tissue beyond where resistance is felt; and

reading through the transparent zone a second graduated marking on the second metering system, wherein the second graduated marking is aligned with the edge between the transparent zone and the opaque zone.

14. The method of claim 13, further comprising releasing the implant from the guidewire.

15. The method of claim 14, wherein the implant provides a flow passageway between the anterior chamber and the suprachoroidal space.

16. The method of claim 13, wherein inserting the implant comprises inserting the entire implant into the anterior chamber.

17. The method of claim 13, wherein the first metering system further comprising a blank band at the distal end region of the guidewire having a width.

18. The method of claim 17, wherein the width of the blank band corresponds to a width of the implant remaining within the anterior chamber once the implant is inserted into the eye tissue.

19. The method of claim 13, further comprising retaining the implant on the guidewire using a polymeric retention coating.

20. The method of claim 13, wherein seating a distal end of the guidewire at eye tissue where resistance is felt comprises seating the guidewire with a portion of the ciliary body having a tissue border with the scleral spur.

21. A method of implanting an ocular device into an eye, comprising:

loading onto a delivery device a shunt having a proximal end, a distal end and a fluid passageway extending between the proximal end and the distal end;

inserting the shunt loaded on the delivery device through an incision in a cornea and into an anterior chamber of the eye;

passing the shunt from the anterior chamber past the scleral spur near the ciliary body of the eye into the suprachoroidal space; and

positioning the shunt in a first position such that a first portion of the fluid passageway communicates with the anterior chamber and a second portion of the fluid passageway communicates with the suprachoroidal space to provide a fluid passageway between the suprachoroidal space and the anterior chamber.

22. The method of claim 21, wherein inserting the shunt through the incision comprises passing the distal end of the shunt through the incision followed by the proximal end of the shunt.

23. The method of claim 21, wherein passing the shunt from the anterior chamber past the scleral spur near the ciliary body of the eye into the suprachoroidal space comprises dissecting a portion of the ciliary body away from a portion of scleral tissue.

24. The method of claim 23, wherein the distal end of the shunt has a shape that is sufficiently blunt so as not to substantially penetrate the scleral spur or the portion of scleral tissue.

25. The method of claim 21, wherein passing the shunt from the anterior chamber past the scleral spur near the ciliary body of the eye into the suprachoroidal space comprises creating a puncture in the ciliary body and inserting the shunt through the puncture.

26. The method of claim 25, wherein inserting the shunt through the puncture further comprises passing the shunt through the puncture until a decrease in resistance to passage is sensed.

27. The method of claim 21, wherein positioning the shunt in the first position comprises substantially surrounding the shunt by eye tissue between the anterior chamber and the suprachoroidal space.

28. The method of claim 21, wherein loading the shunt onto the delivery device comprises inserting a distal end of the delivery device into a loading device, the loading device having an atraumatic funnel that tapers into a cavity sized and configured to hold the shunt and a relief distal to the cavity sized and configured to accommodate the distal end of the delivery device and not the shunt.

29. The method of claim 28, wherein the distal end of the delivery device comprises a metering system.

30. The method of claim 29, wherein the metering system is configured to provide visual guidance regarding depth of advancement of the shunt positioned on the delivery device into an anatomic region of the eye.