Iontophoretic drug delivery apparatus

• US 6,169,920 B1
• Filed: 10/11/1994
• Issued: 01/02/2001
• Est. Priority Date: 06/02/1992
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Landrau, Felix A., Haak, Ronald P., Meyers, Robert M., Sanders, Harold F., Kleiner, Lothar W., Gyory, J. Richard
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/320,387
• Time in Patent Office: 2,275 Days
• Field of Search: 128/802, 128/803, 128/798, 128/640, 604/20, 606/149-152, 607/152
• US Class Current: 604/20
• CPC Class Codes: A61N 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/0444 Membrane
• CPC Class Codes: A61N 1/0448 Drug reservoir
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428

Abstract

An iontophoretic delivery device (10) is provided. Device (10) has an electronic circuit (32) having electronic components such as batteries (30) mounted thereon. Device (10) also includes a pair of electrode assemblies (18, 19). The electronic circuit (32) is electrically connected to the electrode assemblies (18, 19) using an electrically conductive adhesive (34). The adhesive can also be used to electrically connect two or more electronic components within circuit (32) or to connect an electronic component to the electronic circuit (32). In one practice of the invention, the electrically conductive adhesive (44) functions as an electrode and electrically connects the circuit (32) to an agent-containing reservoir (24, 25). In a further practice of the invention, the electrically conductive adhesive (93) functions as an agent reservoir and contains the agent to be iontophoretically delivered.

Claims

1. An iontophoretic agent delivery device comprising:

a reservoir for containing the agent to be iontophoretically delivered, said reservoir being adapted to be placed in agent transmitting relation with a body surface through which said agent is to be delivered;

an electronic circuit, electrically connected to said reservoir, said circuit having a plurality of electronic components, and including a source of electrical energy, and having a circuit output, said electronic circuit being capable of controlling the level of electric current applied by the device;

a polymeric adhesive means in direct electrical contact with said circuit output, said adhesive means being electronically conductive and comprising at least a portion of the electrical connection of the circuit to the reservoir, said adhesive means being capable of repeated bending, twisting or deforming so as to permit the reservoir to conform to the body surface to which the reservoir is adapted to be placed in agent transmitting relation throughout the normal range of body surface movement and activity without breakage of the electrical connection.

2. The device of claim 1 wherein the adhesive means adheres to, and electrically connects, the circuit output and an electrode, which electrode is in electrical contact with the reservoir.

3. The device of claim 1, wherein the adhesive means adheres to, and electrically connects, the circuit output and the agent reservoir.

4. The device of claim 3, wherein the adhesive means contains an electrochemically reactive species.

5. The device of claim 4, wherein the adhesive means comprises an anodic electrode and the electrochemically reactive species is capable of undergoing electrochemical oxidation.

6. The device of claim 4, wherein the adhesive means comprises a cathodic electrode and the electrochemically reactive species is capable of undergoing electrochemical reduction.

7. The device of claim 1, wherein the adhesive means comprises a conductive web, mat or mesh and an adhesive matrix.

8. The device of claim 1, wherein the adhesive means comprises an adhesive matrix containing a conductive filler.

9. The device of claim 8, wherein the adhesive matrix comprises a hydrophobic polymer and a tackifying resin.

10. The device of claim 8, wherein the adhesive matrix comprises a pressure sensitive adhesive.

11. The device of claim 8, wherein the adhesive matrix comprises low molecular weight polyisobutylene and high molecular weight polyisobutylene in a volume ratio of about 6:

1 to about 2;

1.

12. The device of claim 8, wherein the filler comprises a conductive particulate or fibrous material.

13. The device of claim 12, wherein the conductive filler comprises carbon particles or fibers.

15. The device of claim 1 wherein the electrically conductive adhesive means is formed by laminating at least one layer of an adhesive material to at least one electrically conductive web, mesh or mat.

16. The device of claim 15 wherein the electrically conductive adhesive means is formed by laminating:

a first adhesive layer, overlying;

an electrically conductive web, mat or mesh.

17. The device of claim 16, wherein the electrically conductive web, mat or mesh overlies a second adhesive layer.

18. The device of claim 16 wherein the conductive web, mat or mesh is comprised of carbon fibers.

19. The device of claim 1 wherein the adhesive means has a resistivity of less than about 1000 ohm-cm.

20. The device of claim 1 wherein the conductive adhesive means comprises at least a portion of said reservoir.

21. The device of claim 1 wherein the adhesive means contains a liquid retaining additive.

22. The device of claim 21 wherein the additive comprises a hydrophilic polymer.

14. The device of 12, wherein the conductive filler comprises metal particles or flakes.

23. An iontophoretic agent delivery device comprising:

a reservoir for containing the agent to be iontophoretically delivered, said reservoir being adapted to be placed in agent transmitting relation with a body surface through which said agent is to be delivered;

an electronic circuit electrically connected to said reservoir, said circuit having a plurality of electronic components, and including a source of electrical energy, and two circuit outputs, said circuit being capable of controlling the level of electric current applied by the device, said circuit being capable of conforming to the contours of the body surface to which the reservoir is to be placed in agent transmitting relation;

an anode and a cathode, each of said anode and said cathode being directly electrically connected to one of said circuit outputs by an electrically conductive polymeric adhesive means which adheres to said circuit outputs and said electrodes, in at least a portion thereof, to connect said circuit outputs to said electrodes, said adhesive means being capable of repeated bending, twisting or deforming so as to permit the reservoir to conform to the body surface to which the reservoir is adapted to be placed in agent transmitting relation throughout the normal range of body surface movement and activity without breakage of the electrical connection.

24. The device of claim 23 wherein the source of electrical energy comprises a battery.

25. The device of claim 23 wherein the electrically conductive adhesive is formed by laminating at least one layer of an adhesive material to at least one electrically conductive web, mat or mesh.

26. The device of claim 25 wherein the electrically conductive adhesive is formed by laminating:

a first adhesive layer, overlying;

an electrically conductive web, mat or mesh.

27. The device of claim 26, wherein the electrically conductive web, mat or mesh overlies a second layer of adhesive.

28. The device of claim 27 wherein the additive is hydrophilic.

29. In an iontophoretic delivery device including a reservoir for containing the agent to be delivered and an electronic circuit having a plurality of electronic components, including a source of electrical energy, and having a circuit output, a method of coupling the circuit output to an electrode comprising the steps of:

providing an electrode in electrical contact with the reservoir; and

electrically connecting the circuit output to the electrode by applying a sheet of an electrically conductive, polymeric adhesive to the circuit output and to the electrode the sheet being capable of repeated bending, twisting or deforming so as to permit the electrode to remain in contact with the reservoir.

30. The method of claim 29, wherein the sheet is flexible.

31. The method of claim 29, wherein the electrically conductive adhesive comprises an adhesive matrix and an electrically conductive filler.

32. The method of claim 31, wherein the adhesive matrix comprises a hydrophobic polymer and a tackifying resin.

33. The method of claim 31, wherein the adhesive matrix comprises a pressure sensitive adhesive.

34. The method of claim 31, wherein the adhesive matrix comprises low molecular weight polyisobutylene and high molecular weight polyisobutylene in a volume ratio of about 6:

1 to about 2;

1.

35. The method of claim 31, wherein the filler comprises a conductive particulate or fibrous material.

36. The method of claim 31, wherein the conductive filler comprises carbon particles or fibers.

37. The method of claim 31, wherein the conductive filler comprises metal particles or flakes.

38. The method of claims 29, wherein the adhesive comprises a conductive web, mat or mesh and an adhesive matrix.

39. The method of claim 29 wherein the electrically conductive adhesive comprises a laminate of an adhesive material and at least one electrically conductive web, mesh or mat.

40. The method of claim 39 wherein the electrically conductive adhesive is formed by laminating:

a first adhesive layer, overlying;

an electrically conductive web, mat or mesh.

41. The method of claim 40, wherein the electrically conductive web, mat or mesh overlies a second adhesive layer.

42. The method of claim 40 wherein the conductive web, mat or mesh is comprised of carbon fibers.

43. The method of claim 29 wherein the electrically conductive adhesive has a resistivity of less than about 1000 ohm-cm.

44. An iontophoretic agent delivery device comprising:

a reservoir for containing the agent to be iontophoretically delivered, said reservoir being adapted to be placed in agent transmitting relation with a body surface through which said agent is to be delivered;

an electronic circuit having a plurality of electronic components including a source of electrical energy, and having a circuit output electrically connected to the reservoir, said electronic circuit being capable of controlling the level of electronic current applied by the device;

an electrically conductive polymeric adhesive, in the form of a sheet, adhering to and electrically connecting at least two of said electronic components said sheet being capable of repeated bending, twisting or deforming so as to permit the sheet to remain in contact with said electronic components.

45. The device of claim 44, wherein the adhesive comprises a conductive web, mat or mesh and an adhesive matrix.

46. The device of claim 44, wherein the adhesive comprises an adhesive matrix containing a conductive filler.

47. The device of claim 46, wherein the adhesive matrix comprises a hydrophobic polymer and a tackifying resin.

48. The device of claim 46, wherein the adhesive matrix comprises a pressure sensitive adhesive.

49. The device of claim 46, wherein the adhesive matrix comprises low molecular weight polyisobutylene and high molecular weight polyisobutylene in a volume ratio of about 6:

1 to about 2;

1.

50. The device of claim 46, wherein the filler comprises a conductive particulate or fibrous material.

51. The device of claim 50, wherein the conductive filler comprises carbon particles or fibers.

53. The device of claim 44 wherein the electrically conductive adhesive comprises a laminate of an adhesive material and at least one electrically conductive web, mesh or mat.

54. The device of claim 53 wherein the electrically conductive adhesive is formed by laminating:

a first adhesive layer, overlying;

an electrically conductive web, mat or mesh.

55. The device of claim 54, wherein the electrically conductive web, mat or mesh overlies a second adhesive layer.

56. The device of claim 54 wherein the conductive web, mat or mesh is comprised of carbon fibers.

57. The device of claim 44 wherein the electrically conductive adhesive has a resistivity of less than about 1000 ohm-cm.

52. The device of 50, wherein the conductive filler comprises metal particles or flakes.

58. In an iontophoretic delivery device for delivery of an agent through a body surface, the device being adapted to be placed in agent transmitting relation with a body surface, said device also being capable of conforming to the contours of the body surface to which said device is to transmit agent throughout the normal range of body surface movement and activity, the device including a reservoir for containing the agent to be delivered and an electronic circuit having a plurality of electronic components, including a source of electrical energy, and having a circuit output, a method of coupling the circuit output to an electrode comprising the steps of:

providing an electrode in electrical contact with the reservoir; and

electrically connecting the circuit output to the electrode by applying a sheet of an electrically conductive, polymeric adhesive to the circuit output and to the electrode, the sheet being capable of repeated bending, twisting or deforming so as to permit the device to conform to the body surface to which the device is adapted to be placed in agent transmitting relation throughout the normal range of body surface movement and activity without breakage of the electrical connection.