DRUG DELIVERY DEVICES AND METHODS

• US 20110238075A1
• Filed: 12/20/2010
• Published: 09/29/2011
• Est. Priority Date: 12/23/2009
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Transcend Medical Incorporated (Alcon Incorporated)
• Inventors: Iandhulev, Tsonteho, Silvestrini, Thomas A., John, Steven, Clauson, Luke
• Granted Patent: US 8,529,492 B2
• Time in Patent Office: Days
• US Class Current: 606/107
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• 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: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 47/30 Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61M 2210/0606 Face
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

This disclosure relates generally to methods and devices for use in treating eye conditions with implantable drug delivery devices. One method includes introducing an implant into the suprachoroidal space, wherein the interior volume of the implant is plugged with a drug-release material comprising at least one active agent that elutes through at least one opening in the implant, wherein the drug-release material degrades from the interior volume of the implant over a period time.

Claims

1. A method of treating an ocular disorder of an eye, comprising:

forming a self-sealing incision in the cornea of the eye into the anterior chamber;

introducing through the incision an implant comprising a proximal end, a distal end, and an interior volume in fluid communication with at least one opening, wherein the interior volume is plugged with a drug-release material comprising at least one active agent;

passing the distal end and the proximal end of the implant through the anterior chamber;

positioning the distal end of the implant into the suprachoroidal space; and

eluting the at least one active agent from the drug-release material through the at least one opening to treat the eye, wherein the drug-release material degrades from the interior volume of the implant over a period of at least 12 hours.

2. The method of claim 1, wherein the drug-release material comprises poly(lactic-co-glycolic) acid.

3. The method of claim 1, wherein the at least one active agent is released over a period of 12 days.

4. The method of claim 1, wherein the at least one active agent comprises taxol.

5. The method of claim 1, wherein the at least one opening further comprises an inflow port at the proximal end and an outflow port at the distal end wherein the interior volume extends through the implant between the inflow port and the outflow port.

6. The method of claim 5, wherein the drug-release material prevents substantial flow of fluid through the implant from the inflow port to the outflow port over the period of at least 12 hours.

7. The method of claim 6, wherein the drug-release material does not prevent substantial flow of fluid through the implant from the inflow port to the outflow port after the period of at least 12 hours.

8. The method of claim 1, wherein the drug-release material comprises nanostructures facilitating zero order kinetic release.

9. A method of treating an ocular disorder of an eye, comprising:

forming a self-sealing incision in the cornea into the anterior chamber of the eye;

introducing through the incision an implant comprising a proximal end with at least one inflow port, a distal end with at least one outflow port, and an interior volume extending through the implant between the at least one inflow port and at least one outflow port, wherein the implant is mounted on a delivery wire of an implantation instrument extending through the interior volume of the implant;

passing the distal end and the proximal end of the implant through the anterior chamber;

positioning the distal end of the implant into the suprachoroidal space using the implantation instrument; and

flowing a drug-release material comprising at least one active agent through the delivery wire of the implantation instrument and the interior volume of the implant.

10. The method of claim 9, further comprising eluting the at least one active agent from the drug-release material to treat the eye.

11. The method of claim 9, wherein flowing the drug-release material comprises depositing a bolus of the drug-release material to a location distal to the implant into the suprachoroidal space.

12. The method of claim 9, further comprising withdrawing the delivery wire from the interior volume of the implant leaving the implant within the eye.

13. The method of claim 12, wherein flowing the drug-release material comprises flowing the drug-release material into the interior volume of the implant upon withdrawal of the delivery wire from the interior volume.

14. The method of claim 13, wherein the drug-release material prevents substantial flow of fluid through the implant over a period of at least 12 hours.

15. The method of claim 14, wherein the drug-release material does not prevent substantial flow of fluid through the implant after the period of at least 12 hours.

16. A method of delivering to the eye a therapeutic agent to treat an eye condition, comprising:

loading an implantation device with one or more bodies of drug delivery polymer impregnated with the therapeutic agent and adapted to elute the therapeutic agent over time;

forming an incision in the cornea of the eye;

passing the implantation device through the incision into the eye along a pathway through the anterior chamber and into at least a portion of the supraciliary space;

implanting the one or more bodies with the implantation device into a location in the eye; and

eluting the therapeutic agent from the one or more bodies.

17. The method of claim 16, wherein the one or more bodies are selected from the group comprising pellets, beads, particles, gels, nanotubes, and fibers.

18. The method of claim 16, wherein the one or more bodies are implanted in a single location within the eye using the implantation device.

19. The method of claim 16, wherein at least one of the one or more bodies is formulated to include at least two drug delivery zones each adapted to elute the therapeutic agent over time.

20. The method of claim 19, wherein the at least two drug delivery zones elute at least one therapeutic agent.

21. The method of claim 16, wherein the two or more bodies are implanted in at least one location within the eye during a single application using the implantation device.

22. The method of claim 21, wherein the two or more bodies are impregnated with a single therapeutic agent.

23. The method of claim 21, wherein the two or more bodies are impregnated with more than one therapeutic agent.

24. The method of claim 16, wherein the location comprises the supraciliary space, the suprachoroidal space or a location near the back of the eye.

25. A method of delivering to the eye a therapeutic agent to treat an eye condition, comprising:

loading an implantation device with a filamentous body comprising a shape memory material and a drug delivery polymer impregnated with the therapeutic agent adapted to elute the therapeutic agent over time;

forming an incision in the cornea of the eye;

passing the implantation device through the incision into the eye along a pathway through the anterior chamber and into at least a portion of the supraciliary space;

implanting the filamentous body with the implantation device into a location in the eye such that the filamentous body changes from a first shape to a second shape upon release from the implantation device into the eye, wherein the first shape is relatively straight and the second shape is coiled; and

eluting the therapeutic agent from the filamentous body into the eye.

26. The method of claim 25, wherein the location comprises a supraciliary space location, a suprachoroidal space location or a location near the back of the eye.

27. The method of claim 25, wherein the coiled second shape is cupped to hug a curve of the eye.

28. A device to deliver to a location in the eye a therapeutic agent to treat an eye condition, the device comprising:

a filamentous body comprising a shape memory material and a drug delivery polymer impregnated with the therapeutic agent adapted to elute the therapeutic agent over time, wherein the filamentous body changes from a first shape that is relatively straight to a second shape that is coiled upon release from an implantation device into the eye.

29. The device of claim 28, wherein the location comprises a supraciliary space location, a suprachoroidal space location or a location near the back of the eye.

30. The device of claim 28, wherein the coiled second shape is cupped to hug a curve of the eye.

31. The device of claim 28, wherein the shape memory material is selected from the group comprising a polymer and a shape memory metal alloy.

32. A device for delivering to an eye a therapeutic agent to treat an eye condition, comprising:

an elongate, filamentous body having a proximal end and a distal end and comprising a polymer matrix impregnated with the therapeutic agent that is adapted to elute the therapeutic agent into the eye over time, wherein the proximal end is adapted for at least partial placement in a first location of the eye, and wherein the distal end is adapted to extend to a second location within the eye.

33. The device of claim 32, wherein the first location comprises a supraciliary space location or a suprachoroidal space location.

34. The device of claim 33, wherein the second location comprises a location near the back of the eye.

35. The device of claim 32, wherein the elongate, filamentous body further comprises an anchor coupled near the proximal end, the anchor adapted to anchor the filamentous body within the eye.

36. The device of claim 32, wherein the elongate, filamentous body further comprises a grasping element coupled near the proximal end and extending into a region of the anterior chamber.