OCULAR IMPLANT DELIVERY SYSTEMS AND METHODS

• US 20100280317A1
• Filed: 04/02/2010
• Published: 11/04/2010
• Est. Priority Date: 04/03/2009
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Transcend Medical Incorporated (Alcon Incorporated)
• Inventors: Silvestrini, Thomas A., Lilly, Richard S.
• Granted Patent: US 8,337,393 B2
• Time in Patent Office: Days
• US Class Current: 600/109
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 1/044 for absorption imaging
• CPC Class Codes: A61B 1/051 Details of CCD assembly
• CPC Class Codes: A61B 1/06 with illuminating arrangements
• CPC Class Codes: A61B 1/0646 with illumination filters
• CPC Class Codes: A61B 1/07 using light-conductive means, e.g. optical fibres
• CPC Class Codes: A61B 2090/309 using white LEDs
• CPC Class Codes: A61B 5/0086 using infrared radiation
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• 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
• CPC Class Codes: A61F 9/008 using laser

Abstract

Described herein are delivery devices and methods of using the devices for delivering an ocular implant into a suprachoroidal space without use of a goniolens. The delivery device includes a handle including a channel extending from a proximal end of the handle to a distal end of the handle, an applier coupled to the handle, the applier including a blunt distal tip and an elongate, flexible wire insertable through a fluid channel of an ocular implant, and a fiber optic image bundle reversibly inserted through the channel such that the fiber optic image bundle extends to a region proximal to the blunt distal tip of the applier.

Claims

1. A system for delivering an ocular implant having a fluid channel, the system comprising:

a delivery device comprising;

a handle component having a proximal end, a distal end, and a channel extending therethrough; and

an applier coupled to the handle comprising an elongate, flexible wire insertable through the fluid channel of the ocular implant; and

a fiber optic image bundle reversibly insertable through the channel such that the fiber optic image bundle extends to a region proximal to a distal tip of the applier.

2. The system of claim 1, further comprising an illumination source that emits infrared light selected from the group comprising an infrared LED and an infrared flood lamp.

3. The system of claim 2, wherein the illumination source is external to the fiber optic image bundle.

4. The system of claim 2, further comprising a second illumination source.

5. The system of claim 4, wherein the second illumination source emits visible light selected from the group comprising white incandescent light, white LED and fiberoptic white light.

6. The system of claim 4, further comprising a first mechanism configured to control the first illumination source and a second mechanism configured to control the second illumination source, wherein the second illumination source control mechanism adjusts the second illumination source independent of the first illumination source control mechanism and the first illumination source.

7. The system of claim 2, further comprising a narrow band pass filter.

8. The system of claim 2, further comprising an imaging device configured to capture image data in the form of video images, still images or both.

9. The system of claim 8, wherein the imaging device is selected from the group comprising a hand-held digital microscope, a digital camera;

a CCD video camera, a low mass camera, and a CMOS chip.

10. The system of claim 8, wherein the imaging device communicates the image data to a digital projector configured to project images in real-time to a small projector screen displayed near a patient'"'"'s eye.

11. The system of claim 1, wherein the region proximal to the distal tip of the applier is between about 3 and 20 millimeters proximal to the distal tip of the applier.

12. The system of claim 1, wherein the fiber optic image bundle further comprises one or more lenses.

13. The system of claim 1, wherein the fiber optic image bundle provides an objective angle view of at least about 65 degrees.

14. The system of claim 1, further comprising an elongate member having a flow pathway, at least one inflow port communicating with the flow pathway, and an outflow port communicating with the flow pathway, wherein the elongate member is adapted to be positioned in an eye such that the inflow port communicates with an anterior chamber and the outflow port communicates with a suprachoroidal space.

15. The system of claim 14, wherein the elongate member is positioned into a suprachoroidal space without use of a goniolens.

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

loading an implant having a fluid passageway onto a delivery device, the delivery device comprising an applier and a handle component comprising a channel;

feeding a fiber optic image bundle through the channel, wherein a distal end of the fiber optic image bundle is positioned proximal to a distal end of the applier;

forming an incision in a cornea of the eye;

inserting the implant loaded on the applier through the incision into an anterior chamber of the eye;

passing the implant along a pathway from the anterior chamber into a suprachoroidal space;

positioning at least a portion of the implant into the suprachoroidal space 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; and

removing the implant from the applier.

17. The method of claim 16, wherein feeding the fiber optic image bundle comprises reversibly inserting the distal end of the fiber optic image bundle through the channel of the handle component to a position proximal to the distal end of the applier.

18. The method of claim 16, wherein feeding the fiber optic image bundle comprises reversibly inserting the distal end of the fiber optic image bundle through the channel of the handle component to a position between about 3-20 millimeters proximal to the distal end of the applier.

19. The method of claim 16, wherein feeding the fiber optic image bundle comprises reversibly inserting the distal end of the fiber optic image bundle through the channel of the handle component to about 6 millimeters proximal to the distal end of the applier.

20. The method of claim 16, wherein the fiber optic image bundle is less than about 0.5 millimeters in diameter.

21. The method of claim 16, wherein inserting the implant loaded on the applier through the incision into the anterior chamber of the eye comprises inserting the implant loaded on the applier and the fiber optic image bundle through a single incision in the cornea into the anterior chamber of the eye.

22. The method of claim 16, wherein forming an incision comprises forming an incision that is a self-sealing incision.

23. The method of claim 16, wherein passing the implant along a pathway from the anterior chamber into the suprachoroidal space comprises bluntly dissecting between a tissue boundary of a region of the sclera and a tissue boundary of a region of a ciliary body.

24. The method of claim 16, wherein the applier further comprises a retention layer surrounding an outer surface of the applier comprised of a compliant polymer providing a reversible interference fit between the applier and the implant.

25. The method of claim 16, further comprising providing an illumination source to illuminate the eye during implantation, wherein the illumination source is external to the fiber optic image bundle.

26. The method of claim 25, wherein the illumination source emits infrared light.

27. The method of claim 25, further comprising providing a second illumination source to illuminate the eye during implantation, wherein the second illumination source emits white light.

28. The method of claim 27, wherein the second illumination source is adjusted independently of the first illumination source.