Drug delivery devices, kits and methods therefor

• US 8,521,273 B2
• Filed: 01/29/2009
• Issued: 08/27/2013
• Est. Priority Date: 01/29/2008
• Status: Expired due to Fees

• Current Assignee: Microchips Biotech, Inc. (Keratin Biosciences, Inc.)
• Original Assignee: Gilbert H. Kliman
• Inventors: Kliman, Gilbert H.
• Primary Examiner(s): Mehta, Bhisma
• Application Number:
  US12/362,460
• Publication Number:
  US 20090196903A1
• Time in Patent Office: 1,671 Days
• Field of Search: 604/20, 604/21, 604/521, 604/890.1, 604/891.1
• US Class Current: 604/20
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61P 27/02 Ophthalmic agents

Abstract

Implantable drug delivery devices, and kits and methods incorporating them are described. The devices may, for example, be configured for implantation into an ocular region of a subject. The drug delivery devices may comprise multiple, selectively-triggerable drug reservoirs for administration of sequential or concomitant drug regimens. Some variations of devices may comprise one or more reservoirs that may be triggered by an optical stimulus, e.g., light having a wavelength within a certain wavelength range. The devices, methods, and kits may be useful in the treatment chronic ocular conditions, such as age-related macular degeneration.

Claims

1. A kit comprising:

a drug delivery device for implantation into an eye, the device comprising;

a device body comprising an elongated cylindrical structure in its implanted configuration having an annular wall defining a first reservoir configured to be loaded with a first agent; and

a first target region of the annular wall extending circumferentially around the annular wall about the first reservoir, wherein the first target region is visually differentiated from other non-target portions of the annular wall without a target region;

wherein the drug delivery device is configured to release the first agent from the first reservoir through an orifice created in the annular wall at the first target region by application of a first optical stimulus to the first target region, wherein the orifice may be formed at any position around a circumference of the annular wall in the first target region; and

an implantation device configured to implant the drug delivery device into an eye of a patient.

2. The kit of claim 1, further comprising a first optical source configured to deliver the first optical stimulus to the first target region.

3. The kit of claim 2, wherein the first optical source is selected from the group consisting of:

an argon ion laser, a Nd;

YAG laser, a frequency-doubled Nd;

YAG laser, a diode laser, a Nd;

YLF laser, a helium-neon laser, a krypton ion laser, and a dye laser.

4. The kit of claim 2, wherein the first optical stimulus is a pulsed light.

5. The kit of claim 2, further comprising at least one focusing apparatus to adjust a power density of the first optical stimulus emitted from the first optical source.

6. The kit of claim 5, wherein the at least one focusing apparatus comprises a lens.

7. The kit of claim 1, wherein the implantation device comprises a 20 gauge or smaller cannula.

8. A drug delivery device for implantation into an eye, the drug delivery device comprising:

a device body comprising an elongated cylindrical structure in its implanted configuration having an annular wall defining a first reservoir configured to be loaded with a first agent; and

a first target region of the annular wall extending circumferentially around the annular wall about the first reservoir, wherein the first target region is visually differentiated from other non-target portions of the annular wall;

wherein the drug delivery device is configured to release the first agent from the first reservoir through an orifice created in the annular wall at the first target region by application of a first optical stimulus to the first target region, wherein the orifice may be formed at any position around a circumference of the annular wall in the first target region.

9. The drug delivery device of claim 8, wherein the annular wall of the device body further defines:

a second reservoir configured to be loaded with a second agent and further comprises a second target region extending circumferentially around the annular wall about the second reservoir.

10. The drug delivery device of claim 9, wherein the drug delivery device is configured to release the second agent from the second reservoir through an orifice created in the annular wall at the second target region by application of a second optical stimulus to the second target region.

11. The drug delivery device of claim 10, wherein the first optical stimulus has a first wavelength and the second optical stimulus has a second wavelength.

12. The drug delivery device of claim 10, wherein the first optical stimulus has a first power density and the second optical stimulus has a second power density.

13. The drug delivery device of claim 10, wherein the first optical stimulus has an incident beam having a first spot size and the second optical stimulus has an incident beam having a second spot size.

14. The drug delivery device of claim 10, wherein the first optical stimulus has an incident beam having a first spot geometry and the second optical stimulus has an incident beam having a second spot geometry.

15. The drug delivery device of claim 9, wherein the first reservoir is disposed in a first body section of the device body and the second reservoir is disposed in a second body section of the device body, the first body section and the second body section being coupled together.

16. The drug delivery device of claim 9, wherein the device body comprises a unitary body structure and a barrier is disposed between the first and second reservoirs.

17. The drug delivery device of claim 9, wherein the first agent and the second agent are the same agent.

18. The drug delivery device of claim 9, wherein the first agent and the second agent are different agents.

19. The drug delivery device of claim 9, wherein the annular wall of the device body further defines:

a third reservoir configured to be loaded with a third agent and comprises a third target region extending circumferentially around the annular wall about the third reservoir,

wherein the drug delivery device is configured to release the third agent from the third reservoir through an orifice created in the annular wall at the third target region in response to application of an optical stimulus to the third target region.

20. The drug delivery device of claim 9, wherein the first target region and the second target region of the annular wall is are visually differentiated from other non-target portions of the annular wall.

21. The drug delivery device of claim 20, wherein the first target region of the annular wall is visually differentiated from the second target region of the annular wall.

22. The drug delivery device of claim 9, wherein the first target region comprises a first chromophore that absorbs a first wavelength emitted from the first optical stimulus, and the second target region comprises a second chromophore that absorbs a second wavelength emitted from a second optical stimulus.

23. The drug delivery device of claim 9, wherein at least one of the first and second agents is selected from the group consisting of:

anti-inflammatories, anti-infectives, anti-allergens, cholinergic agonists and antagonists, adrenergic agonists and antagonists, anti-glaucoma agents, agents for cataract prevention or treatment, neuroprotection agents, anti-oxidants, antihistamines, anti-platelet agents, anti-coagulants, anti-thrombic agents, anti-scarring agents, antiproliferatives, anti-tumor agents, complement inhibitors, decongestants, vitamins, growth factors, anti-growth factor agents, gene therapy vectors, chemotherapy agents, protein kinase inhibitors, small interfering RNAs, limus family compounds, and combinations thereof.

24. The drug delivery device of claim 23, wherein at least one of the first and second agents comprises an anti-growth factor agent.

25. The drug delivery device of claim 24, wherein the anti-growth factor agent comprises an anti-VEGF agent.

26. The drug delivery device of claim 25, wherein the anti-VEGF agent comprises aflibercept.

27. The drug delivery device of claim 25, wherein the anti-VEGF agent comprises ranibizumab.

28. The drug delivery device of claim 25, wherein the anti-VEGF agent comprises bevacizumab.

29. The drug delivery device of claim 23, wherein at least one of the first and second agents comprises an anti-inflammatory agent.

30. The drug delivery device of claim 29, wherein the anti-inflammatory agent comprises a steroidal agent.

31. The drug delivery device of claim 30, wherein the steroidal agent comprises dexamethasone.

32. The drug delivery device of claim 30, wherein the steroidal agent comprises triamcinolone.

33. The drug delivery device of claim 30, wherein the steroidal agent comprises fluocinolone.

34. The drug delivery device of claim 23, wherein at least one of the first and second agents comprises a limus family compound.

35. The drug delivery device of claim 34, wherein the limus family compound comprises rapamycin.

36. The drug delivery device of claim 23, wherein at least one of the first and second agents comprises a complement inhibitor.

37. The drug delivery device of claim 9, wherein the first and second agents are selected to be part of a concomitant combination drug regimen.

38. The drug delivery device of claim 9, wherein the first and second agents are selected to be part of a sequential drug regimen.

39. The drug delivery device of claim 8, wherein the drug delivery device is configured to be free-floating in the eye.

40. The drug delivery device of claim 8, wherein the annular wall of the device body defines a plurality of reservoirs, each of the plurality of reservoirs configured to be loaded with a respective agent.

41. The drug delivery device of claim 40, wherein the plurality of reservoirs is at least five reservoirs.

42. The drug delivery device of claim 40, wherein the plurality of reservoirs is at least ten reservoirs.

43. The drug delivery device of claim 8, wherein the first optical stimulus comprises a first optical radiation having a first wavelength from about 500 nm to about 1500 nm.

44. The drug delivery device of claim 43, wherein the first wavelength is from about 500 nm to about 700 nm.

45. The drug delivery device of claim 44, wherein the first wavelength is from about 500 nm to about 600 nm.

46. The drug delivery device of claim 8, wherein the first optical stimulus is selected from the group consisting of an argon ion laser, a Nd:

YAG laser, a frequency-doubled Nd;

YAG laser, a diode laser, a Nd;

YLF laser, a krypton laser, a dye laser, and a helium-neon laser.

47. The drug delivery device of claim 8, wherein the first target region of the annular wall comprises a chromophore capable of absorbing a first wavelength emitted from the first optical stimulus.

48. The drug delivery device of claim 8, wherein the first reservoir is configured to release the first agent through the orifice created in the annular wall at the first target region via diffusion into the eye.

49. The drug delivery device of claim 8, wherein the first reservoir is configured to release the first agent in a sustained manner after the formation of the first orifice in the annular wall at the first target region.

50. The drug delivery device of claim 8, wherein the device is configured for the treatment of age-related macular degeneration.

51. The drug delivery device of claim 8, wherein the device is configured to be implanted in a vitreous cavity, a retina, a sclera, a cornea, or a conjunctiva of the eye of a patient.

52. The drug delivery device of claim 8, wherein the device is configured for the treatment of diabetic retinopathy.

53. The drug delivery device of claim 8, wherein the device is configured for treatment of macular degeneration.

54. The drug delivery device of claim 8, wherein the device is configured for treatment of glaucoma.

55. The drug delivery device of claim 8, wherein the first target region of the annular wall extends about 360 degrees circumferentially around the annular wall about the first reservoir.