Device and method for renewing electrodes during iontophoresis

• US 5,320,597 A
• Filed: 02/08/1991
• Issued: 06/14/1994
• Est. Priority Date: 02/08/1991
• Status: Expired due to Term

• Current Assignee: Vyteris, Inc.
• Original Assignee: Becton, Dickinson & Co
• Inventors: Bock, Carl R., Sage, Burton H. Jr.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Rafa, Michael
• Application Number:
  US07/652,855
• Time in Patent Office: 1,222 Days
• Field of Search: 604/20, 604/49, 128/798, 128/802, 128/803
• US Class Current: 604/20
• CPC Class Codes: A61N 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0448 Drug reservoir
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428

Abstract

The present invention provides an iontophoretic drug delivery device having electrode renewing features includes a housing having a first electrode, a second electrode, a circuit for providing electrical communication between the first and second electrodes. The circuit is capable of engaging a source of current. Control means is provided for effecting the amount of current passing between the electrodes. A removable electrolyte reservoir is capable of holding electrolyte and removably engaging the housing so that one of the electrodes can contact electrolyte contained within the reservoir. A removable active agent reservoir is capable of holding an active agent for iontophoretic delivery. The active agent reservoir is capable of removably engaging the housing so that the active agent contacts one of the electrodes.

The present invention also provides a method for renewing electrodes during delivery of an active agent from an iontophoretic system which comprises at least two electrodes and means for containing an active agent, which method comprises:

a) delivering an active agent in connection with a first electrode which completes a circuit with a second electrode in connection with an electrolyte, and

b) delivering an active agent from the second electrode by replacing the electrolyte with an active agent in connection with the second electrode and replacing the active agent with an electrolyte in connection with the first electrode.

Claims

1. An operable iontophoretic delivery device having electrode renewing features comprising:

housing means including a first electrode, a second electrode, insulating means for electrically separating said first and second electrodes, circuit means providing for electrical communication between said first and second electrodes, said circuit means adapted to engage a source of current for providing current between said first and second electrodes, switch means for changing the direction of said current, and control means for affecting the amount of current passing between said electrodes;

a removable electrolyte reservoir capable of holding electrolyte, said electrolyte reservoir capable of removably engaging said housing so that one of said electrodes can contact electrolyte contained in said reservior; and

a removable active agent reservoir capable of holding an active agent for iontophoretic delivery, said active agent reservoir capable of removably engaged said housing so that said active agent can contact one of said electrodes.

2. The operable iontophoretic delivery device of claim 1 wherein said source of current is a battery.

3. The operable iontophoretic delivery device of claim 2 wherein said battery is contained within said housing means.

4. The operable iontophoretic delivery devide of claim 1 wherein said electrodes are selected from the group consisting of silver, silver halides, gold, gold halides, copper, copper halides, molybdenum and molybdenum halides.

5. The operable iontophoretic delivery device of claim 4 wherein one of said electrodes is silver.

6. The operable iontophoretic delivery device of claim 4 wherein one of said electrodes is silver chloride.

7. The operable iontophoretic delivery device of claim 4 wherein said electrodes are silver chloride and silver.

11. The operable iontophoretic delivery device of claim 1 wherein said control means includes means for maintaining a constant current between said first and second electrodes.

12. The operable iontophoretic delivery device of claim 1 wherein said control means includes means for maintaining a constant voltage between said first and second electrodes.

13. The operable iontophoretic delivery device of claim 1 wherein said active agent reservoir contains a therapeutic agent.

14. The operable iontophoretic delivery device of claim 13 wherein said therapeutic agent is selected from the group consisting of insulin, calcitonin, lidocaine, somatostatin, elcatonin, and the ionic forms thereof.

8. The operable iontophoretic delivery device of claim further including holding means for holding said electrolyte reservoir and said active agent reservoir in spaced relationship so that both reservoirs may be simultaneously removably connected to said housing with either reservoir aligned with either electrode.

9. The operable iontophoretic delivery device of claim 8 further including adhesive for holding said reservoirs adjacent to the skin of a patient.

10. The operable iontophoretic delivery device of claim 9 including a removable release sheet for covering said adhesive before the time of use and for covering said reservoirs.

15. An operable iontophoretic drug delivery device having electrode renewing features comprising:

housing means including a first electrode contact means, a second electrode contact means, insulating means for electrically separating said first and said second electrode contact means, circuit means providing for electrical communication between said first and second contact means, said circuit means adapted to engage a source of current for providing current between said first and second electrode contact means, and control means for affecting the amount of current passing between said first and second electrode contact means;

a removable first reservoir including a first electrode, said first reservoir adapted to hold an active agent or an electrolyte in contact with said first electrode, said first reservoir capable of removably engaging said housing so that said first electrode can contact one of said contact means; and

a removable second reservoir including a second electrode, said second reservoir adapted to hold an active agent or an electrolyte in contact with said second electrode, said second reservoir capable of removably engaging said housing so that said second electrode can contact the other of said contact means.

16. The operable iontophoretic delivery device of claim 15 further including adhesive on said first and second reservoirs for holding said reservoirs adjacent to the skin of a patient.

17. The operable iontophoretic device of claim 16 including a removable release sheet for covering said adhesive before time of use and for covering said reservoirs.

18. A method for renewing electrodes during delivery of an active agent from an iontophoretic system which comprises at least two electrodes and means for containing an active agent, which method comprises:

a) delivering an active agent in connection with a first electrode which completes a circuit with a second electrode in connection with an electrolyte, and

b) delivering an active agent from the second electrode by replacing the electrolyte with an active agent in connection with the second electrode and replacing the active agent with an electrolyte in connection with the first electrode.

19. The method of claim 18 in which the delivery of the active agent is from a cathode.

20. The method of claim 18 in which the delivery of the active agent is from an anode.

21. The method of claim 18 in which the electrodes are metals and their salts which have reversible electrochemistries with an interface potential less than that required for electrolysis of water.

22. The method of claim 21 in which the electrodes are selected from the group consisting of silver, silver halides, gold, gold halides, copper, copper halides, molybdenum and molybdenum halides.

23. The method of claim 22 in which the electrodes are silver and silver chloride.

24. The method of claim 18 in which the active agent is selected from the group consisting of insulin, calcitonin, lidocaine, somatostatin, elcatonin, and the ionic forms thereof.

25. The method of claim 23 in which the active agent is lidocaine.

26. The method of claim 18 in which the electrolyte is selected from the group consisting of active agent, saline, and aqueous solutions of halide salts.

27. The method of claim 26 in which the electrolyte is saline.

28. The method of claim 26 in which the electrolyte is an aqueous solution of halide salts.

29. The method of claim 18 in which delivery of active agent from the second electrode is effected by a switching means.

30. The method of claim 18 in which the electrodes are silver and silver chloride and the electrolyte is saline.

31. The method of claim 18 in which the electrodes are silver and silver chloride, the electrolyte is saline, and the active agent is lidocaine hydrochloride.