Implantable drug delivery device and use thereof

• US 7,563,255 B2
• Filed: 05/02/2002
• Issued: 07/21/2009
• Est. Priority Date: 05/03/2001
• Status: Active Grant

• Current Assignee: Charles Stark Draper Laboratory Incorporated, Massachusetts Eye And Ear Infirmary (Foundation of The Massachusetts Eye and EAR Infirmary Incorporated)
• Original Assignee: Charles Stark Draper Laboratory Incorporated, Massachusetts Eye And Ear Infirmary (Foundation of The Massachusetts Eye and EAR Infirmary Incorporated)
• Inventors: Borenstein, Jeffrey T., Weinstein, Marcie G., Hansberry, Mitchell L., Miller, Raanan A., Mescher, Mark J., Miller, Joan W., Gragoudas, Evangelos S., Adamis, Anthony P., Dube, Christopher E.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Bouchelle; Laura A
• Application Number:
  US10/139,656
• Publication Number:
  US 20030069560A1
• Time in Patent Office: 2,637 Days
• Field of Search: 604/89, 604/132, 604/294, 604/891.1
• US Class Current: 604/294
• 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: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)

Abstract

The invention provides a miniaturized, implantable drug delivery device and a method of delivering over a prolonged period of time one or more drugs using such a device. The drug delivery device can be adapted for attachment to the outer surface of an eye. Once attached to the outer surface of an eye, the device can deliver one or more drugs directly into the eye for preventing or ameliorating the symptoms of a particular ocular disorder.

Claims

1. An implantable drug delivery device, comprising:

(a) a casing defining an inner volume, and comprising an outer surface, the outer surface comprising an eye-contacting surface, wherein the eye-contacting surface comprises a shape complementary to an outer surface of a mammalian eye, and wherein when implanted, the eye-contacting surface substantially conforms to the outer surface of a mammalian eye, the eye-contacting surface defining an aperture port passing therethrough, wherein the inner volume is in fluid flow communication with the outside of the casing;

(b) a reservoir member comprising a drum disposed within the casing, wherein the reservoir member defines a cavity for receiving the drug; and

(c) a seal attached to the reservoir member for sealing drug within the cavity, which when punctured permits drug disposed within the cavity to be released into the inner volume and to exit the casing via the aperture port defined in the eye-contacting surface.

2. The drug delivery device of claim 1 wherein the reservoir member comprises a plurality of cavities.

3. The drug delivery device of claim 1 wherein the cavity is defined by an outer surface of the drum.

4. The drug delivery device of claim 1 wherein the reservoir member is a drum and the cavity is defined by a compliant material radially disposed about the drum.

5. The drug delivery device of claim 1 wherein the reservoir member is a flexible support member and the cavity is defined by one side of the support member.

6. The drug delivery device of claim 1 further comprising a puncturing member for breaking the seal.

7. The drug delivery device of claim 6 wherein the puncturing member comprises a cutting instrument or a puncturing instrument.

8. The drug delivery device of claim 6 wherein the puncturing member is fixed relative to the reservoir member.

9. The drug delivery device of claim 6 wherein the puncturing member rotates relative to the reservoir member.

10. The drug delivery device of claim 6 or 9 wherein the puncturing member translates relative to the reservoir member.

11. The drug delivery device of claim 6 further comprising a drive mechanism for moving the puncturing member.

22. The drug delivery device of claim 1 or 12 further comprising a drug disposed within the cavity.

23. The drug delivery device of claim 22 wherein the drug, when disposed within the cavity, is in solid, liquid, or gel form.

24. The drug delivery device of claim 1 or 12 wherein a plurality of drugs are disposed within the cavity.

42. A method of delivering a drug to a preselected locus in a mammal, the method comprising the steps of:

(a) attaching the implantable drug delivery device of claim 1, 12, or 26 to a preselected tissue surface in the mammal; and

(b) permitting drug disposed within the cavity to be released from the cavity and exit the casing through the aperture port.

43. The method of claim 42 wherein in step (a) the device is sutured to the preselected surface.

44. The method of claim 42 wherein in step (a) the device is attached to an outer surface of an eye.

45. The method of claim 44 wherein in step (b) the drug passes through the sclera and into the eye.

12. An implantable drug delivery device, comprising:

(a) a casing defining an inner volume, and comprising an outer surface, the outer surface comprising an eye-contacting surface, wherein the eye-contacting surface comprises a shape complementary to an outer surface of a mammalian eye, and wherein when implanted, the eye-contacting surface substantially conforms to the outer surface of a mammalian eye, the eye-contacting surface defining an aperture port passing therethrough, wherein the inner volume is in fluid flow communication with the outside of the casing;

(b) a rotatable drum disposed within the casing and having a surface defining a cavity for receiving the drug;

(c) a seal attached to the surface for sealing drug within the cavity; and

(d) a puncturing member for breaking the seal to permit drug disposed within the cavity to be released into the inner volume and exit the casing via the aperture port defined in the eve-contacting surface.

13. The drug delivery device of claim 12 wherein the drum comprises a plurality of cavities.

14. The drug delivery device of claim 12 wherein the puncturing member comprises a cutting instrument or a puncturing instrument.

15. The drug delivery device of claim 12 wherein the puncturing member is fixed relative to the drum.

16. The drug delivery device of claim 12 wherein the puncturing member moves relative to the drum.

17. The drug delivery device of claim 16 wherein the puncturing member rotates relative to the drum.

18. The drug delivery device of claim 16 or 17 wherein the puncturing member translates relative to the drum.

19. The drug delivery device of claim 16 further comprising a drive mechanism for moving the puncturing member relative to the drum.

20. The drug delivery device of claim 12 further comprising a drive mechanism for rotating the drum.

21. The drug delivery device of claim 12 wherein the cavity is defined by a compliant material radially disposed about the drum.

25. The drug delivery device of claim 2 or 13 wherein a first drug is disposed within a first cavity and a second, different drug is disposed within a second cavity.

26. An implantable drug delivery device, comprising:

(a) a casing defining an inner volume, and comprising an outer surface, the outer surface comprising an eye-contacting surface, wherein the eye-contacting surface comprises a shape complementary to an outer surface of a mammalian eye, and wherein when implanted, the eye-contacting surface substantially conforms to the outer surface of a mammalian eye, the eye-contacting surface defining an aperture port passing therethrough;

(b) a rotatable drum disposed within the casing and having a surface defining a plurality of cavities for receiving the drug radially disposed about the drum, wherein all the cavities do not lie in a single diametral plane; and

(c) a seal attached to the drum for sealing drug within at least one cavity, which when punctured permits drug disposed within a cavity to exit the casing via the aperture port defined in the eye-contacting surface.

27. The drug delivery device of claim 26 wherein the cavities are helically disposed about the surface of the drum.

28. The drug delivery device of claim 26 wherein the cavities are disposed as an array about the surface of the drum.

29. The drug delivery device of claim 26 further comprising a puncturing member for breaking the seal.

30. The drug delivery device of claim 29 wherein the puncturing member comprises a cutting instrument or a puncturing instrument.

31. The drug delivery device of claim 30 wherein the puncturing member is fixed relative to the drum.

32. The drug delivery device of claim 26 wherein the puncturing member moves relative to the drum.

33. The drug delivery device of claim 32 wherein the puncturing member rotates relative to the drum.

34. The drug delivery device of claim 32 or 33 wherein the puncturing member translates relative to the drum.

35. The drug delivery device of claim 26 wherein the seal is degradable.

36. The drug delivery device of claim 32 further comprising a drive mechanism for moving the puncturing member.

37. The drug delivery device of claim 26 further comprising a drive mechanism for rotating the drum.

38. The drug delivery device of claim 26 wherein the drum rotates about an axis from a first position in which the sealed cavity is in spaced apart relation relative to the aperture port to a second position in which the cavity is adjacent the aperture port.

39. The drug delivery device of claim 26 wherein the cavities are defined by a compliant material radially disposed about the drum.

40. The drug delivery device of claim 26 further comprising a drug disposed within the sealed cavity.

41. The drug delivery device of claim 40 wherein the drug, when disposed within the cavity, is in solid, liquid or gel form.

46. An implantable drug delivery device, comprising:

(a) a casing defining an inner volume, and comprising an outer surface, the outer surface comprising an eye-contacting surface, wherein the eye-contacting surface comprises a shape complementary to an outer surface of a mammalian eye, and wherein when implanted, the eye-contacting surface substantially conforms to the outer surface of a mammalian eye, the eye-contacting surface defining an aperture port passing therethrough;

(b) a reservoir member disposed within the casing, wherein the reservoir member defines a plurality of cavities for receiving the drug; and

(c) a seal attached to the reservoir member for sealing the cavity, which when punctured permits drug disposed within the cavity to exit the casing through the aperture port defined in the eye-contacting surface.

47. The drug delivery device of claim 46 wherein the reservoir member is a drum and the cavity is defined by an outer surface of the drum.

48. The drug delivery device of claim 46 wherein the reservoir member is a drum and the cavity is defined by a compliant material disposed about the drum.

49. The drug delivery device of claim 47 or 48 wherein the drum is rotatable.

50. The drug delivery device of claim 49 further comprising a drive mechanism coupled to the drum.

51. The drug delivery device of claim 46 further comprising a puncturing member.

52. The drug delivery device of claim 51 wherein the puncturing member comprises a cutting instrument or a puncturing instrument.

53. The drug delivery device of claim 51 wherein the puncturing member is fixed relative to the reservoir member.

54. The drug delivery device of claim 51 wherein the puncturing member moves relative to the reservoir member.

55. The drug delivery device of claim 54 wherein the puncturing member rotates relative to the reservoir member.

56. The drug delivery device of claim 54 or 55 wherein the puncturing member translates relative to the reservoir member.

57. The drug delivery device of claim 54 further comprising a drive mechanism coupled to the puncturing member.

58. The drug delivery device of claim 46 wherein the seal is degradable.

59. The drug delivery device of claim 46 further comprising a drug disposed within the cavity.

60. The drug delivery device of claim 59 wherein the drug, when disposed within the cavity, is in solid, liquid or gel form.

61. A method of delivering a drug to the interior of a mammalian eye, the method comprising the steps of:

(a) attaching the implantable drug delivery device of claim 46 to an outer surface of the eye; and

(b) permitting drug disposed within the cavity to be released from the cavity and exit the casing through the aperture port.

62. The method of claim 61 wherein in step (a) the implantable drug delivery device is sutured to the outer surface of the eye.

63. The method of claim 61 wherein in step (a) the implantable drug delivery device is attached to the outer surface of the eye so that the aperture port is positioned adjacent to the outer surface of the eye.