Drug delivery device

• US 7,190,997 B1
• Filed: 06/04/2000
• Issued: 03/13/2007
• 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 (Itrik)
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US09/980,908
• Time in Patent Office: 2,473 Days
• Field of Search: 604 19- 21, 604/518, 604/519, 604/65, 604/67, 604/200, 607/115, 607/120, 607/122, 607/3, 607/9, 607/39, 607/40, 424/422
• US Class Current: 607/3
• 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

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 apart of a heart, said programming selected to achieve a desired provision of said molecule into at least a portion of a patient'"'"'s heart or associated vasculature.

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 which has a transport effect for transporting a molecule in a desired manner and has a non-excitatory control effect, which does not induce a propagating action potential in the heart, independent of the transport effect, adapted to electrically control an activity of at least a part of a heart,

said programming selected to achieve a desired provision of said molecule into tissue including at least a portion of a patient'"'"'s heart or associated vasculature.

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 said 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 of 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 a molecule source containing said molecule.

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.

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.

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 said 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 cardiac parameter and provides said sensed parameter to said controller.

23. Apparatus according to claim 22, wherein said sensor measures a cardiac parameter relating to the entire heart.

24. Apparatus according to claim 22, wherein said sensor measures a cardiac parameter relating to a portion of the heart.

25. Apparatus according to claim 22, wherein said controller analyses said sensed parameter to detect an effect of said molecule on said heart.

26. Apparatus according to claim 22, wherein said controller is configured to analysze said sensed parameter to detect an activity of the heart and wherein said controller is configured to synchronize 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 heart.

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 said patient.

33. Apparatus according to claim 1, wherein the controller is adapted to apply a single electric field which has both of said transport effect and said control effect.

34. Apparatus according to claim 1, wherein the controller is adapted to apply at least one transport field which has a transport effect but not a control effect and at least one control field which has a non-excitatory control effect.

35. Apparatus according to claim 34, wherein the controller is adapted to apply the transport field and control field simultaneously.

36. Apparatus according to claim 34, wherein the controller is adapted to apply the transport field and control field sequentially.

37. Apparatus according to claim 34, wherein the controller is configured to apply during a single heart treatment session a transport field which is accompanied by the control field only during part of the application of the transport field.

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 said 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 50, wherein said at least one control electrode is spatially displaced from said at least one transport electrode.

52. 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.

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 controller 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 is comprised in 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 the controller is not configured to apply excitatory electrical fields.

71. Apparatus according to claim 1, wherein the transport effect comprises releasing the molecule from a reservoir into tissue.

72. Apparatus according to claim 1, wherein the transport effect comprises transporting the molecule within tissue.

73. Apparatus according to claim 1, wherein the transport effect comprises transporting the molecule into tissue cells.

74. A method of selectively delivering a molecule, comprising:

providing a molecule adjacent a heart; and

applying at least one electric field having a transport effect for transporting a molecule in a desired manner into at least a portion of said heart or a vasculature associated with the heart and having a non-excitatory electrical control effect, which does not induce a propagating action potential in the heart, for controlling the activity of at least a part of said heart.