Device for sealing the capsular bag of an eye and a method for delivering fluid or treatment substances to the lens of an eye

• US 20040010284A1
• Filed: 08/22/2003
• Published: 01/15/2004
• Est. Priority Date: 11/28/2000
• Status: Active Grant

• Current Assignee: Anthony Maloof, Geoffrey Neilson
• Original Assignee: Anthony Maloof, Geoffrey Neilson
• Inventors: Neilson, Geoffrey, Maloof, Anthony
• Granted Patent: US 7,708,723 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• 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

Abstract

Disclosed are devices and methods for the transfer of fluids and potentially toxic chemicals into the lens capsule by creating a closed system preventing the fluids from entering the anterior chamber of the eye and thus causing damage to other ocular structures.

The invention comprises one or more fluid conduits which communicate with a plug which maybe inserted through the corneal incision and placed onto the anterior surface of the capsule around the capsulorhexis. The plug is adapted to seal against the anterior surface of the lens capsule.

In preferred embodiments, the flow of fluids into and out of the plug (and therefore the capsule) are controlled from a separate fluid flow controller.

Claims

1. A device that seals an opening of a capsular bag of an eye comprising:

a. A plug

b. A rim about the periphery of the plug

c. A passage in fluid communication with the rim

wherein the rim is adapted for positioning adjacent to the lens of the eye such that applying a vacuum to the passage substantially seals and affixes the rim relative to the capsular bag of the lens and forms a substantially closed cavity between the interior portion of the device and the capsular bag of the lens.

2. The device of claim 1, comprising

a. a cover assembly which has a flat or domed segment above a rim, the assembly having an external diameter smaller than the diameter of the lens and an internal diameter large enough to seal around an opening in the capsular bag.

b. An inner surface residing with in the cover assembly, and defining a gap between the inner surface and the cover assembly thereby defining the rim for sealing around an opening in the capsular bag;

and

c. A lumen extending from the gap and terminating exterior to the eye whereby fluids or vacuum may be applied to the lumen.

3. The device of claim 1 wherein there are one or more additional lumens through the plug through which a substantially fluid substance may pass through to the capsular bag.

4. The device of claim 3, where the one or more additional lumens enter an interior surface of the plug.

5. The device of claim 3 where there are two or more additional lumens through the plug for fluid irrigation and aspiration to the interior of the capsular bag.

6. The device of claim 3 where there are separate irrigation and aspiration lumens through the plug.

7. The device of claim 3, wherein one or more lumens enter the plug interior tangentially and/or inclined toward the capsule surface to provide a swirling motion to the irrigating fluid.

8. The device of claim 6, where an ID of the aspiration lumen is larger than an ID of the irrigation lumen.

9. The device of either of claims 3 or 6, where an aspiration lumen is located at a highest interior point.

10. The device of claim 3, where an aspiration lumen port is covered by a screen or castellation to prevent the capsule sealing the port and thus blocking fluid flow.

11. The device of claim 1, wherein the device may be folded or rolled or compressed without damage into a generally cylindrical or semicircular form and is sufficiently flexible and resilient such that it returns to its original shape when released.

12. The device of claim 1, being sufficiently resilient such that its shape is retained when positive or negative pressure of up to 760 mmHg is applied to one or more passages.

13. The device of claim 1, adapted to be rolled or folded and then inserted using forceps or other surgical instruments into the interior of the eye though a standard cataract corneal incision.

14. The device of claim 1, adapted to be rolled or folded and inserted into a delivery tube.

15. The device of claim 1, adapted to be deformed to a tapered or cylindrical configuration when pulled back into a delivery tube.

16. The device of claim 15, further comprising regions of weakness such as fold lines to facilitate collapsing.

17. The device of claim 1 further comprising a substantially rigid inner and outer conduits having flush distal ends which are perpendicular to the surface of the capsular bag when angled though the cornea.

18. The device of claim 3 which further comprises an additional controller which provides a specified vacuum to the rim.

19. The device of claim 18 whereby irrigation is halted when a pressure sensor and/or flow meter detects a vacuum leak.

20. The device of claim 18 where irrigation and aspiration are controlled by pumps such as a peristaltic or a syringe pumps such that the fluid volume in the capsule does not exceed the capsule volume.

21. The device of claim 1 wherein the fixation to the capsular bag is by an inflatable seal.

22. The device of claim 1 wherein the fixation is by biocompatible adhesive such as fibrin glue.

23. The device of claim 1, further comprising a generally rigid manipulation handle which my be either integral to the device or removable.

24. A method whereby treatment fluids are passed into the capsular bag of the eye, which has been substantially sealed from remainder of the internal eye by the device of claim 1.

25. The method of claim 24 whereby a testing process is employed by irrigating with a neutral fluid to test the seal of the device of claim 1 prior to using an active chemical.

26. The method of claim 24 whereby an active chemical is used with the device of claim 1 to destroy lens epithelial cells.

27. The method of claim 24 whereby an neutralising chemical is passed through the device of claim 1 to neutralise the active chemical

28. The method of claim 24 whereby irrigation and aspiration proceeds with controlled irrigation and/or vacuum pressure.

29. The method of claim 24 whereby irrigation and aspiration proceeds with controlled irrigation and/or vacuum fluid flow.

30. The method of claim 24 whereby the volume of the capsule is kept constant.

31. The method of claim 24 whereby the capsule is repeatedly inflated and deflated though the repeated irrigation and aspiration of a set fluid volume.

32. A plug for sealing against a capsular bag and providing fluid communication with an interior of the bag, comprising:

an inner tube which terminates in a flange;

the flange adapted to pass through a rhexis;

a second close fitting tube;

the second tube adapted to slide over the first tube so as to clamp the capsular bag between the second tube and the flange.

33. The plug of claim 32, wherein:

the inner tube has a central bore into which one or more lumens may pass directly into the capsular bag.

36. The plug of any one of claims 32 to 35, further comprising:

one or more lumens passing through the plug, which lumen may carry fluid into or out of the capsular bag.

37. The plug of claim 36, wherein:

there are separate irrigation and aspiration lumens.

38. The plug of claim 36, wherein:

an ID of an aspiration lumen is larger than an ID of an irrigation lumen.

34. A plug for sealing against a capsular bag and providing fluid communication with an interior of the bag, comprising:

a tube terminating in a flange;

the flange adapted to pass through a rhexis;

an inflatable seal located above the flange;

a conduit leading from the seal to a means for inflating the seal so as to clamp the capsular bag between the seal and the flange.

35. A plug for sealing against a capsular bag and providing fluid communication with an interior of the bag, comprising:

concentric inner and outer tubes;

the tubes having angled and flush ends;

a gap at the ends defining a rim;

an internal diameter of the inner tube providing access to the interior of the capsular bag.