Drug delivery device

• US 7,092,753 B2
• Filed: 12/14/2000
• Issued: 08/15/2006
• Est. Priority Date: 06/04/1999
• Status: Expired due to Term

• Current Assignee: Impulse Dynamics NV
• Original Assignee: Impulse Dynamics NV
• Inventors: Darvish, Nissim, Shemer, Itzhak (Itsik)
• Primary Examiner(s): Kennedy, Sharon
• Application Number:
  US10/048,802
• Publication Number:
  US 20020183686A1
• Time in Patent Office: 2,070 Days
• Field of Search: 604/20, 604/21, 604/51, 604/53, 604/95.05, 607/120, 607/122, 606/35
• US Class Current: 604/21
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation

Abstract

Apparatus (800) for targeted release of a molecule carried in a circulating reservoir, comprising: at least one electrode (804); and a controller (810) adapted to electrify said electrode (804) with at least one electric field, said electric field operative to have at least one desired effect related to said circulating reservoir with said molecule, wherein said electrode and said electrification are adapted such that at least one of said effects is selectively applied to a particular blood vessel that carries blood through tissue and wherein said at least one effect that is selectively applied comprises a release effect, which releases said molecule from said circulating reservoir that circulates in said blood vessel.

Claims

1. Apparatus for targeted release of a molecule carried in a circulating reservoir, comprising:

at least one electrode; and

a controller adapted to electrify said electrodes with at least one electric field, said electric field operative to have at least one desired effect related to said circulating reservoir with said molecule, wherein said electrode and said electrification are adapted such that at least one of said at least one effects is selectively applied to a particular blood vessel that carries blood through tissue and wherein said at least one effect that is selectively applied comprises a release effect, which releases said molecule from said circulating reservoir that circulates in said blood vessel.

2. Apparatus according to claim 1, where said at least one electrode comprises at least two electrodes.

3. Apparatus according to claim 1, where said at least one electrode comprises at least one multi-element electrode, the electrification of which elements is separately controllable by said controller.

4. Apparatus according to claim 1, wherein said circulating reservoir comprises liposomes that encapsulate said molecule.

5. Apparatus according to claim 1, wherein said at least one electrode is adapted to be mounted on an outside of a blood vessel.

6. Apparatus according to claim 1, wherein said at least one electrode is adapted to be mounted on an inside of a blood vessel.

7. Apparatus according to claim 1, comprising a stent-body adapted to be lodged in said blood vessel and on which said electrode is mounted.

8. Apparatus according to claim 7, wherein said at least one electrode comprises a ring electrode.

9. Apparatus according to claim 7, wherein said at least one electrode comprises a plurality of axially spaced apart arc-portion electrodes.

10. Apparatus according to claim 7, wherein said stent body is designed for a particular blood vessel diameter.

11. Apparatus according to claim 7, wherein said stent body is expandable to match a range of different diameters.

12. Apparatus according to claim 1, comprising at least one functional sensor operative to sense an activation state of said tissue.

13. Apparatus according to claim 12, wherein said functional sensor senses a local activation state of said tissue.

14. Apparatus according to claim 12, wherein said functional sensor senses a global activation state of said tissue.

15. Apparatus according to claim 12, wherein said sensor comprises an electrical activity sensor.

16. Apparatus according to claim 12, wherein said sensor comprises a mechanical activity sensor.

17. Apparatus according to claim 12, wherein said controller synchronizes said electrification to said sensed activation state.

18. Apparatus according to claim 1, wherein said controller electrifies said electrode such that said at least one electrical field has a transport effect of transporting said molecule from said blood vessel outside of said blood vessel.

19. Apparatus according to claim 1, wherein said controller electrifies said electrode such that said at least one electrical field has a transport effect of transporting said molecule into cells at or near said blood vessel.

20. Apparatus according to claim 1, wherein said controller electrifies said electrode such that said at least one electrical field has a controlling effect on said tissue.

21. Apparatus according to claim 20, wherein said controller electrifies said electrode such that said controlling effect interacts with said molecule to have a desired therapeutic effect caused by said controlling effect and said molecule.

22. Apparatus according to claim 20, wherein said controller electrifies said electrode such that said controlling effect interacts with said molecule to have a desired molecule delivery effect.

23. Apparatus according to claim 20, wherein said controller electrifies said electrode such that said controlling effect counteracts a negative effect of at least one of said molecule and said at least one electric field.

24. Apparatus according to claim 20, wherein said controller electrifies said electrode such that said controlling effect prevents a negative effect of at least one of said molecule and said at least one electric field.

25. Apparatus according to claim 18, wherein said controller electrifies said electrode such that said at least one electric field is an excitatory field for said tissue.

26. Apparatus according to claim 18, wherein said controller electrifies said electrode such that said at least one electric field is a non-excitatory field for said tissue.

27. Apparatus according to claim 18, wherein said controller electrifies said electrode such that at least said desired effect and said transport effect are provided using separate electric fields.

28. Apparatus according to claim 27, wherein said controller electrifies said electrode such that at least said desired effect and said transport effect are provided using different field directions.

29. Apparatus according to claim 18, wherein said controller electrifies said electrode such that at least said desired effect and said transport effects are achieved by a single electric field.

30. Apparatus according to claim 1, comprising at least one reservoir containing a second molecule.

31. Apparatus according to claim 30, wherein said reservoir is adapted to release said second molecule towards a wall of said blood vessel.

32. Apparatus according to claim 30, wherein said reservoir is adapted to release said second molecule towards a lumen of said blood vessel.

33. Apparatus according to claim 30, wherein said controller electrifies said at least one electrode to transport said second molecule out of said reservoir.

34. Apparatus according to claim 30, wherein said apparatus releases said second molecule at a dosage suitable to inhibit an activity of said molecule.

35. Apparatus according to claim 30, wherein said apparatus releases said second molecule at a dosage suitable to enhance an activity of said molecule.

36. Apparatus according to claim 30, wherein said apparatus releases said second molecule at a dosage suitable to have its activity enhanced by said molecule.

37. Apparatus according to claim 30, wherein said apparatus releases said second molecule at a dosage suitable to have its activity inhibited by said molecule.

38. Apparatus according to claim 30, wherein said apparatus releases said second molecule at a dosage suitable to assist in releasing said molecule from said circulating reservoir.

39. Apparatus according to claim 1, wherein said apparatus is adapted to be implanted at a vascular entrance to said tissue.

40. Apparatus according to claim 1, wherein said device is adapted to be implanted at a vascular exit from said tissue.

41. Apparatus according to claim 1, wherein said controller is programmed to operate with tissue that is not electrically excitable.

42. Apparatus according to claim 1, wherein said controller is programmed to operate with tissue that is electrically excitable.

43. Apparatus according to claim 42, wherein said tissue comprises cardiac tissue.

44. Apparatus according to claim 42, wherein said tissue comprises non-cardiac tissue.

45. Apparatus according to claim 44, wherein said tissue comprises smooth muscle tissue.

46. Apparatus according to claim 45, wherein said tissue comprises a bladder.

47. Apparatus according to claim 45, wherein said tissue comprises a uterus.

48. Apparatus according to claim 45, wherein said tissue comprises a digestive tract.

49. Apparatus according to claim 44, wherein said tissue comprises striated muscle tissue.

50. Apparatus according to claim 1, contains a separate portion including:

a second portion electrode; and

an associated reservoir containing an associated molecule,

wherein said apparatus is adapted to release said associated molecule to inhibit an activity of said molecule.

51. Apparatus according to claim 1, wherein said controller is implantable.

52. Apparatus according to claim 1, wherein said controller is adapted to remain outside the body.

53. Apparatus according to claim 51, wherein said controller communicates with said electrode by wired means.

54. Apparatus according to claim 51, wherein said controller communicates with said electrode by wireless means.

55. Apparatus according to claim 1, comprising a power source for providing energy for electrifying said electrode.

56. Apparatus according to claim 55, wherein said power source is adapted to be inside a body.

57. Apparatus according to claim 55, wherein said power source is adapted to be outside a body.

58. Apparatus according to claim 55, wherein said power source provides said energy by wired means.

59. Apparatus according to claim 55, wherein said power source provides said energy by wireless means.

60. Apparatus according to claim 1, comprising a sensor for measuring a physiological parameter.

61. Apparatus according to claim 60, wherein said sensor measures a concentration of said molecule.

62. Apparatus according to claim 60, wherein said controller uses said measurement for determining said electrification.

63. Apparatus according to claim 1, wherein said controller is programmable.

64. Apparatus according to claim 63, wherein said controller is programmable to match different types of circulating reservoirs.

65. Apparatus according to claim 63, wherein said controller is programmable to match different types of molecules.

66. Apparatus according to claim 63, wherein said controller is programmable to provide different treatment protocols.

67. Apparatus according to claim 63, wherein said controller is programmable to be used with different tissue types.

68. Apparatus according to claim 63, wherein said controller is programmable to be used with different tissue sites.

69. A kit including:

apparatus according to claim 1; and

instructions for use.

70. A kit including:

apparatus according to claim 1; and

a quantity of said circulating reservoir.

71. A kit including:

apparatus according to claim 1; and

a quantity of said molecule.

72. A method of targeted release, comprising:

providing a circulating reservoir in a blood stream, said reservoir including a molecule; and

applying an electric field, by a controller and through at least one electrode, the electric field having at least one desired effect on a particular blood vessel containing said circulating reservoir, said field being sufficient to cause release of said molecule from said reservoir.

73. A method according to claim 72, where said at least one electrode comprises at least two electrodes.

74. A method according to claim 72, wherein said circulating reservoir comprises liposomes that encapsulate said molecule.

75. A method according to claim 72, wherein said at least one electrode is mounted on an outside of a blood vessel.

76. A method according to claim 72, wherein said at least one electrode is mounted on an inside of a blood vessel.

77. A method according to claim 72, comprising at least one functional sensor operative to sense an activation state of tissue associated with said blood vessel.

78. A method according to claim 72, wherein said controller electrifies said electrode such that said electric field has a transport effect of transporting said molecule from said blood vessel outside of said blood vessel.

79. A method according to claim 72, wherein said controller electrifies said electrode such that said electric field has a transport effect of transporting said molecule into cells at or near said blood vessel.

80. A method according to claim 72, wherein said controller electrifies said electrode such that said electric field has a controlling effect on tissue associated with with said blood vessel.

81. A method according to claim 80, wherein said controller electrifies said electrode such that said controlling effect interacts with said molecule to have a desired therapeutic effect caused by said controlling effect and said molecule.

82. A method according to claim 80, wherein said controller electrifies said electrode such that said controlling effect interacts with said molecule to have a desired molecule delivery effect.

83. A method according to claim 72, wherein said controller electrifies said electrode such that at least two of said at least one effects are provided using separate electric fields.

84. A method according to claim 72, wherein said controller electrifies said electrode such that at least two of said at least one effects are achieved by a single electric field.

85. A method according to claim 72, wherein the controller operates with tissue not excited by the electric field.

86. A method according to claim 72, wherein the controller operates with cardiac tissue.

87. A method according to claim 72, wherein the controller operates with non-cardiac tissue.

88. A method according to claim 72, wherein the controller operates with smooth muscle tissue.

89. A method according to claim 72, wherein the controller operates with a bladder.

90. A method according to claim 72, wherein the controller operates with a digestive tract.

91. A method according to claim 72, wherein the controller operates with striated muscle tissue.

92. A method according to claim 72, wherein said controller is implanted in a body.

93. A method according to claim 72, wherein said controller remains outside the body.

94. A method according to claim 72, wherein said controller communicates with said electrode by wired means.

95. A method according to claim 72, wherein said controller communicates with said electrode by wireless means.