Device for delivery of antifibrotic agents and method

• US 8,337,447 B2
• Filed: 11/24/2008
• Issued: 12/25/2012
• Est. Priority Date: 05/25/2006
• Status: Active Grant

• Current Assignee: Elutimed, LLC
• Original Assignee: Ramesh S. Ayyala
• Inventors: Ayyala, Ramesh S.
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US12/277,139
• Publication Number:
  US 20090124955A1
• Time in Patent Office: 1,492 Days
• Field of Search: 604/8, 604/9, 623/6.16
• US Class Current: 604/9
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts

Abstract

An ophthalmological device comprises an implant member carrying an antifibrotic agent that is released slowly over a prolonged period when inserted into a wound in an eye produced by surgery. The member is placed in the vicinity of a wound created during the surgery to inhibit inflammatory cell proliferation, thereby preventing the growth of fibrous tissue after the eye surgery.

Claims

1. An implantable glaucoma drainage device including

a tube extending from the device that has a terminal end adapted to be placed within an intraocular chamber of an eye, and

a plate having on a surface of the plate, as a separate element, a porous polymeric member comprising P-HEMA hydrogel, said member carrying an antifibrotic agent,

said device configured to be implantable within a surgical incision in a surface of an eye and a sufficient amount of the antifibrotic agent being retained by the porous polymeric member so that, upon implantation of the device, the antifibrotic agent on contact by an aqueous medium from the eye is released into the incision slowly over a prolonged period in excess of 1 week.

2. The glaucoma drainage device of claim 1 where the antifibrotic agent is released at a rate of substantially from 0.03 to 0.09 milligrams per hour.

3. The glaucoma drainage device of claim 2 where the antifibrotic agent is 5-flurouracil.

4. The glaucoma drainage device of claim 2 where the antifibrotic agent is mitomycin-C.

5. The glaucoma drainage device of claim 1 where the P-HEMA hydrogel is made by redox polymerization with impurities removed.

6. The glaucoma drainage device of claim 1 where the porous polymeric member is a disk.

7. The glaucoma drainage device of claim 1 where the porous polymeric member is a sheet.

8. An implantable glaucoma drainage device including

a tube extending from the device that has a terminal end adapted to be placed within an intraocular chamber of an eye, and

a plate having on a surface of the plate, as a separate element, a porous, biodegradable, polymeric member comprising polylactides and glycolic acid copolymers, said member carrying an antifibrotic agent,

said device configured to be implantable within a surgical incision in a surface of an eye and a sufficient amount of the antifibrotic agent being retained by the porous polymeric member so that, upon implantation of the device, the antifibrotic agent on contact by an aqueous medium from the eye is released into the incision slowly over a prolonged period in excess of 1 week.

9. The glaucoma drainage device of claim 8 where the antifibrotic agent is released at a rate of substantially from 0.03 to 0.09 milligrams per hour.

10. The glaucoma drainage device of claim 9 where the antifibrotic agent is 5-flurouracil.

11. The glaucoma drainage device of claim 9 where the antifibrotic agent is mitomycin-C.

12. The glaucoma drainage device of claim 8 where the porous polymeric member is a disk.

13. The glaucoma drainage device of claim 8 where the porous polymeric member is a sheet.

14. An implantable glaucoma drainage device including

a plate for collecting an aqueous medium from an intraocular chamber of an eye,

a tube extending from the device that has a terminal end adapted to be placed within an intraocular chamber of an eye, said aqueous medium flowing at least in part through the tube to the plate,

said plate having a surface to which is attached, as a separate element, a porous polymeric member carrying an antifibrotic agent, said polymeric member positioned on the plate to receive the aqueous medium so that said aqueous medium contacts and the flows over or through the polymeric member to wash the antifibrotic agent from the polymeric member and into the surgical incision,

said device configured to be implantable within a surgical incision in a surface of an eye and a sufficient amount of the antifibrotic agent being retained by the porous polymeric member so that, upon implantation of the device, the antifibrotic agent on contact by the aqueous medium is released into the incision slowly over a prolonged period in excess of 1 week.

15. The glaucoma drainage device of claim 14 where said polymeric member has width substantially from 4 mm to 15 mm, a length substantially from 4 mm to 15 mm, and a thickness substantially from 0.25 mm to 1.00 mm.

16. The glaucoma drainage device of claim 15 where the antifibrotic agent is released at a rate of substantially from 0.03 to 0.09 milligrams per hour.

17. The glaucoma drainage device of claim 16 where the antifibrotic agent is 5-flurouracil.

18. The glaucoma drainage device of claim 16 where the antifibrotic agent is mitomycin-C.

19. The glaucoma drainage device of claim 14 porous, biodegradable, polymeric member comprising polylactides and glycolic acid copolymers.

20. The glaucoma drainage device of claim 14 where the porous polymeric member is a disk.

21. The glaucoma drainage device of claim 14 where the porous polymeric member is a sheet.

22. An implantable glaucoma drainage device including

a plate for collecting an aqueous medium from an intraocular chamber of an eye,

a tube extending from the device that has a terminal end adapted to be placed within an intraocular chamber of an eye, said aqueous medium flowing at least in part through the tube to the plate,

said plate having a surface to which is attached a porous polymeric member carrying an antifibrotic agent, said polymeric member positioned on the plate to receive the aqueous medium so that said aqueous medium contacts and the flows over or through the polymeric member to wash the antifibrotic agent from the polymeric member and into the surgical incision,

said device configured to be implantable within a surgical incision in a surface of an eye and a sufficient amount of the antifibrotic agent being retained by the porous polymeric member so that, upon implantation of the device, the antifibrotic agent on contact by the aqueous medium is released into the incision slowly over a prolonged period in excess of 1 week,

where the porous polymeric member comprises P-HEMA hydrogel and a silicone rivet attaches the polymeric member to the plate.

23. A method of treating glaucoma comprising

(a) implanting a device into a surgical incision in a surface of an eye under the eye'"'"'s conjunctival/Tenons'"'"' pocket approximately 7-10 millimeters from the eye'"'"'s limbus,

said device including

a tube extending from the device that has a terminal end adapted to be placed within an intraocular chamber of an eye, and

a plate having on a surface of the plate, as a separate element, a porous polymeric member comprising P-HEMA hydrogel, said member carrying an antifibrotic agent,

said device configured to be implantable within a surgical incision in a surface of an eye and a sufficient amount of the antifibrotic agent being retained by the porous polymeric member so that, upon implantation of the device, the antifibrotic agent on contact by an aqueous medium from the eye is released into the incision slowly over a prolonged period in excess of 1 week,

(b) suturing in position,

(c) inserting the tube terminal end into an intraocular chamber the eye.

24. A method of treating glaucoma comprising

(a) implanting a device into a surgical incision in a surface of an eye under the eye'"'"'s conjunctival/Tenons'"'"' pocket approximately 7-10 millimeters from the eye'"'"'s limbus,

said device including

a tube extending from the device that has a terminal end adapted to be placed within an intraocular chamber of an eye, and

a plate having on a surface of the plate, as a separate element, a porous, biodegradable, polymeric member comprising polylactides and glycolic acid copolymers, said member carrying an antifibrotic agent,

said device configured to be implantable within a surgical incision in a surface of an eye and a sufficient amount of the antifibrotic agent being retained by the porous polymeric member so that, upon implantation of the device, the antifibrotic agent on contact by an aqueous medium from the eye is released into the incision slowly over a prolonged period in excess of 1 week,

(b) suturing in position,

(c) inserting the tube terminal end into an intraocular chamber the eye.

25. A method of treating glaucoma comprising

(a) implanting a device into a surgical incision in a surface of an eye under the eye'"'"'s conjunctival/Tenons'"'"' pocket approximately 7-10 millimeters from the eye'"'"'s limbus,

said device including

a plate for collecting an aqueous medium from an intraocular chamber of an eye,

a tube extending from the device that has a terminal end adapted to be placed within an intraocular chamber of an eye, said aqueous medium flowing at least in part through the tube to the plate,

said plate having a surface to which is attached, as a separate element, a porous polymeric member carrying an antifibrotic agent, said polymeric member positioned on the plate to receive the aqueous medium so that said aqueous medium contacts and the flows over or through the polymeric member to wash the antifibrotic agent from the polymeric member and into the surgical incision,

said device configured to be implantable within a surgical incision in a surface of an eye and a sufficient amount of the antifibrotic agent being retained by the porous polymeric member so that, upon implantation of the device, the antifibrotic agent on contact by the aqueous medium is released into the incision slowly over a prolonged period in excess of 1 week,

(b) suturing in position,

(c) inserting the tube terminal end into an intraocular chamber the eye.