Drug delivery device

• US 7,171,263 B2
• Filed: 12/13/2000
• Issued: 01/30/2007
• 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): Manuel; George
• Application Number:
  US10/048,803
• Publication Number:
  US 20020183682A1
• Time in Patent Office: 2,239 Days
• Field of Search: 604/20, 604/21, 604/65, 604/67, 424/422, 607/3, 607/9, 607/39, 607/40
• US Class Current: 604/20
• 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
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

Electrical treatment apparatus (100) for use with an associated molecule source, comprising: at least one electrode (106); a power source (120) for electrifying said at least one electrode; and a controller, which is programmed to activate the power source (120) to selectively electrify said at least one electrode (106) to apply at least one electric field including a transport effect for transporting a molecule in a desired manner and a non-excitatory control effect for controlling the activity of at least a part of a non-cardiac excitable tissue, said programming selected to achieve a desired provision of said molecule into said at least a part of an excitable tissue or associated vasculature, said desired provision being at least assisted by an interaction between the transport effect and the control effect.

Claims

1. Electrical treatment apparatus for use with an associated molecule source, comprising:

at least one electrode;

a power source for electrifying said at least one electrode; and

a controller, which is programmed to activate the power source to selectively electrify said at least one electrode to apply at least one electric field, said at least one electric field having a transport effect for transporting a molecule in a desired manner and a non-excitatory control effect, which does not induce an additional propagating action potential, for controlling the activity of at least a part of a non-cardiac excitable tissue, said programming selected to achieve a desired provision of said molecule into said at least a part of an excitable tissue or associated vasculature, said desired provision being at least assisted by an interaction between the transport effect and the control effect.

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

3. Apparatus according to claim 2, comprising a wireless programming input.

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

5. Apparatus according to claim 1, wherein said programming comprises programming adapted for a patient.

6. Apparatus according to claim 1, wherein said programming comprises a setting of at least one operational parameter of said apparatus.

7. Apparatus according to claim 1, wherein said programming comprises a selection or at least one operational protocol from a set of available protocols in said apparatus.

8. Apparatus according to claim 1, wherein said controller is operable in a testing mode, in which mode a test treatment of a molecule is provided to the patient and the response of the patient to the test is monitored by said controller.

9. Apparatus according to claim 1, comprising a synchronization connection to said molecule source.

10. Apparatus according to claim 9, wherein said synchronization connection comprises an informative connection that provides at least one informative signal to said controller, informing of a state of molecule release.

11. Apparatus according to claim 9, wherein said synchronization connection comprises a control connection that provides at least one control signal from said controller, to control a state of molecule release.

12. Apparatus according to claim 11, wherein said molecule source is an electric-field mediated molecule source and wherein said control signal generates an electric field that releases said molecule from said source.

13. Apparatus according to claim 12, wherein said synchronization connection is comprised in said at least one electrode used for applying a transport effect.

14. Apparatus according to claim 13, wherein said molecule source is integral with said electrode.

15. Apparatus according to claim 13, wherein said molecule source comprises blood dispersed molecules.

16. Apparatus according to claim 1, wherein said molecule source is integral with said at least one electrode used for applying a transport effect.

17. Apparatus according to claim 1, wherein said molecule source is integral with said apparatus.

18. Apparatus according to claim 1, wherein said molecule source is external to said apparatus.

19. Apparatus according to claim 1, wherein said molecule source comprises a catheter, coupled to said apparatus outside a patient.

20. Apparatus according to claim 1, wherein said molecule source comprises a source of a plurality of molecule types.

21. Apparatus according to claim 20, wherein said controller controls said molecule source to selectively release at least a particular one of said plurality of molecule types.

22. Apparatus according to claim 1, comprising at least one sensor that senses a functional tissue parameter and provides said sensed parameter to said controller.

23. Apparatus according to claim 22, wherein said sensor measures a functional tissue parameter relating to the entire excitable tissue.

24. Apparatus according to claim 22, wherein said sensor measures a functional tissue parameter relating to a portion of the excitable tissue.

25. Apparatus according to claim 22, wherein said controller is configured to analyze said sensed parameter to detect an effect of said molecule on said excitable tissue.

26. Apparatus according to claim 22, wherein said controller is configured to analyze said sensed parameter to detect an activity of the excitable tissue and wherein said controller synchronizes said provision to said sensed activity.

27. Apparatus according to claim 22, wherein said controller is configured to analyze said sensed parameter to detect an effect of said field on said excitable tissue.

28. Apparatus according to claim 22, wherein said controller modifies said at least one electric field to modify said transport effect responsive to said sensed parameter.

29. Apparatus according to claim 22, wherein said controller modifies said at least one electric field to modify said control effect responsive to said sensed parameter.

30. Apparatus according to claim 22, comprising a watchdog that detects an abnormal effect of said applied fields.

31. Apparatus according to claim 22, comprising a watchdog that detects an abnormal effect of said molecule.

32. Apparatus according to claim 1, comprising a user input for receiving an indication of an effect of said apparatus from a patient.

33. Apparatus according to claim 1, wherein a single electric field applies both of said transport effect and said control effect.

34. Apparatus according to claim 1, wherein said at least one electric field comprises at least one transport field and at least one control field.

35. Apparatus according to claim 1, wherein said transport effect and said control effect are provided simultaneously.

36. Apparatus according to claim 1, wherein said transport effect and said control effect arc applied sequentially.

37. Apparatus according to claim 1, wherein said control effect is selectively applied in association with only some of said transport effects.

38. Apparatus according to claim 1, comprising at least one pacing electrode that is controlled by said controller to apply a pacing pulse.

39. Apparatus according to claim 38, wherein said at least one pacing electrode is comprised in said at least one electrode.

40. Apparatus according to claim 1, wherein said transport effect is provided by an excitatory field.

41. Apparatus according to claim 1, wherein said transport effect is provided by a non-excitatory field.

42. Apparatus according to claim 1, comprising an output port for generating an output to a patient.

43. Apparatus according to claim 1, wherein said control effect is selected to prevent an adverse effect of said pulse.

44. Apparatus according to claim 1, wherein said control effect is selected to prevent an adverse effect of said molecule.

45. Apparatus according to claim 1, wherein said molecule is selected to counteract an adverse effect of said control effect.

46. Apparatus according to claim 1, wherein said control effect is selected to counteract an adverse effect of said molecule.

47. Apparatus according to claim 1, wherein said control effect is selected to prepare said tissue for said transport.

48. Apparatus according to claim 1, wherein said control effect is selected to extend a period of time suitable for provision of said molecule.

49. Apparatus according to claim 1, wherein said control effect and said molecule are selected to cooperate and effect a desired treatment of said tissue.

50. Apparatus according to claim 1, wherein said at least one electrode comprises at least one transport electrode for applying a transport effect of said at least one field and at least one control electrode for applying said control effect of said at least one field.

51. Apparatus according to claim 1, wherein said transport effect and said control effect of said at least one electric field are applied using at least one common electrode of said at least one electrode.

52. Apparatus according to claim 50, wherein said at least one control electrode is spatially displaced from said at least one transport electrode.

53. Apparatus according to claim 1, wherein said at least one electrode comprises a point electrode.

54. Apparatus according to claim 1, wherein said at least one electrode comprises a spiral electrode.

55. Apparatus according to claim 1, wherein said at least one electrode comprises a linear electrode.

56. Apparatus according to claim 55, wherein said electrode comprises a plurality of independently electrifiable contacts.

57. Apparatus according to claim 56, wherein said controllers selectively electrifies said independent contacts to achieve a desired, non-uniform, volumetric dispersion of said molecule, relative to said electrode.

58. Apparatus according to claim 1, wherein said at least one electrode comprises a mesh electrode.

59. Apparatus according to claim 1, wherein said at least one electrode comprises a plate electrode.

60. Apparatus according to claim 1, wherein said at least one electrode is connected by wire to said controller.

61. Apparatus according to claim 1, wherein said at least one electrode is a wireless electrode.

62. Apparatus according to claim 1, wherein said at least one electrode is implantable.

63. Apparatus according to claim 1, wherein said at least one electrode is mounted on a catheter.

64. Apparatus according to claim 1, wherein said at least one electrode is an external electrode.

65. Apparatus according to claim 1, wherein said apparatus is implantable.

66. Apparatus according to claim 1, wherein said apparatus comprises a cylindrical body adapted for implantation inside a blood vessel.

67. Apparatus according to claim 1, wherein said apparatus is wholly external to the patient.

68. Apparatus according to claim 1, wherein said transport effect comprises iontophoresis.

69. Apparatus according to claim 1, wherein said transport effect comprises electroporation.

70. Apparatus according to claim 1, wherein said non-cardiac excitable tissue comprises uterine tissue.

71. Apparatus according to claim 1, wherein said non-cardiac excitable tissue comprises bladder tissue.

72. Apparatus according to claim 1, wherein said non-cardiac excitable tissue comprises digestive tissue.

73. Apparatus according to claim 1, wherein said transport effect comprises releasing a molecule from a circulating reservoir.

74. Apparatus according to claim 73, wherein said circulating reservoir comprises liposomes in a blood stream.

75. Apparatus according to claim 1, wherein said controller coordinates the interaction of a systemic molecule and locally available molecule, to have a synergistic effect.

76. Apparatus according to claim 75, wherein said local molecule blocks an effect of said systemic molecule.

77. Apparatus according to claim 75, wherein said local molecule enhances an effect of said systemic molecule.

78. Apparatus according to claim 75, wherein said systemic molecule blocks an effect of said local molecule away from said a locality where said local molecule is provided.

79. Apparatus according to claim 75, wherein said systemic molecule enhances an effect of said local molecule.

80. Electrical treatment apparatus for use with an associated molecule source, comprising:

at least one electrode;

a sensor for sensing a functional state of a non-cardiac tissue;

a power source for electrifying said at least one electrode; and

a controller, which is programmed to activate the power source to selectively electrify said at

least one electrode to apply at least one non-excitatory electric field;

said electric field having a transport effect, which does not induce an additional propagating action potential, for transporting a molecule in a desired manner, synchronized to said sensed functional state.