Rate adjustable drug delivery system

• US 7,016,723 B2
• Filed: 06/03/2002
• Issued: 03/21/2006
• Est. Priority Date: 12/30/1999
• Status: Expired due to Term

• Current Assignee: The Tapemark Company
• Original Assignee: Birch Point Medical, Inc.
• Inventors: Morris, Russell L., Anderson, Carter R.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US10/162,473
• Publication Number:
  US 20020188241A1
• Time in Patent Office: 1,387 Days
• Field of Search: 607/2, 604/20
• 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

Abstract

A transdermal iontophoretic therapeutic agent delivery system which is provided with a plurality of self-contained serially connected galvanic sources.

Claims

1. A method of providing power sources and dosage control systems having reliable capacity ratings for transdermal iontophoresis delivery of therapeutic agents, said power source and dosage control systems comprising a plurality of serially connected galvanic couple power sources, the method comprising steps of:

(a) manufacturing one or more lots of galvanic couple power sources;

(b) determining by sample testing capacity characteristics including an average charge capacity for said galvanic couple power sources of each of said one or more lots to produce tested lots;

(c) serially connecting a plurality of said galvanic couple power sources selected from one or more tested lots into power source and control systems;

(d) incorporating said power source and control systems into transdermal iontophoresis therapeutic agent delivery devices as the sole sources of power and delivery control; and

(e) providing labeling indicating average capacity for said agent delivery devices based on the tested average charge capacities of corresponding tested lots from which said plurality of galvanic power sources are taken.

2. A method as in claim 1 comprising the further step of connecting one or more resistance devices in parallel with one or more of said plurality of galvanic power sources.

3. A method as in claim 1 including the step of providing for one or more of said galvanic power sources expire at a different time.

4. A method as in claim 3 further comprising the step of connecting a resistance device in parallel with one or more of said plurality of galvanic power sources.

5. A method as in claim 3 comprising the step of providing a pair of said galvanic power sources in opposed polar relation and in parallel with a resistor device such that iontophoretic delivery current flows to deliver said therapeutic agent only after one source expires.

6. A method as in claim 3 further comprising the step of connecting a switch device across a galvanic power source designed to expire before at least one other.

7. A method as in claim 1 further comprising the step of connecting a switch device across one or more of said serially connected galvanic power sources.

8. A method as in claim 1 wherein said sample testing comprises the step of reacting galvanic sources or half-cells to exhaustion.

9. A method as in claim 1 wherein said plurality of galvanic couple power sources are selected from the same tested lot.

10. A method as in claim 1 wherein said plurality of galvanic couple power sources are selected from a plurality of tested lots.

11. A method as in claim 1 wherein said delivery device is a wearable skin patch.

12. A method as in claim 11 further comprising the step of packaging said delivery device in a dry state separate from said therapeutic agent.

13. A method as in claim 1 further comprising the step of packaging said delivery device in a dry state separate from said therapeutic agent.

14. A method of providing an accurate average available dosage rating for labeling skin-worn transdermal iontophoresis therapeutic agent delivery devices having self-contained combined power source and dosage control systems including a plurality of galvanic couple sources, including steps of sampling and testing average power capacities of lots from which said plurality of galvanic power sources are taken, using test results to determine an average available dosage and labeling said device in accordance with said average available dosage rating.

15. A transdermal iontophoresis therapeutic agent delivery device comprising:

(a) a plurality of self-contained serially connected galvanic power sources, wherein said plurality of galvanic power sources alone provide the power for the device and the control for the rate and dosage of therapeutic agent delivered;

(b) said plurality of galvanic power sources including provision for one or more of said sources to expire at a different time; and

(c) a resistance device connected in parallel with one or more of said galvanic power sources.

16. A device as in claim 15 in the form of a wearable skin patch.

25. A device as in claim 15 having two galvanic power sources.

26. A device as in claim 25 comprising a pair of said galvanic power sources in opposed polar relation and in parallel with a resistor device such that iontophoretic delivery current flows to deliver said therapeutic agent only after one source expires.

27. A device as in claim 15 further comprising a switch connected across one or more of said serially connected galvanic sources.

28. A device as in claim 27 wherein a switch is connected across a galvanic power source designed to expire before at least one other.

29. A device as in claim 28 including a three-position switch.

30. A device as in claim 27 including a three-position switch.

17. A transdermal iontophoretic therapeutic agent delivery device as in 15 further comprising a label associated with said delivery device identifying the capacity of said delivery system and that said capacity is based on the average tested, capacities of corresponding manufactured lots of said plurality of galvanic power sources.

18. A device as in claim 17 in the form of a wearable skin patch.

19. A device as in claim 17 wherein said device is stored in a therapeutic agent-free state until used.

20. A device as in claim 17 having two galvanic power sources.

21. A device as in claim 20 comprising a pair of said galvanic power sources in opposed polar relation and in parallel with a resistor device such that iontophoretic delivery current flows to deliver said therapeutic agent only after one source expires.

22. A device as in claim 21 further comprising a switch connected across one or more of said serially connected galvanic sources.

23. A device as in claim 17 wherein said plurality of galvanic power sources includes one or more sources selected to have significantly lower charge capacity.

24. A device as in claim 23 wherein said device is stored in a therapeutic agent-free state until used.