Iontophoretic drug delivery device and method of manufacturing the same

• US 5,991,655 A
• Filed: 02/26/1998
• Issued: 11/23/1999
• Est. Priority Date: 03/03/1997
• Status: Expired due to Fees

• Current Assignee: Drug Delivery Systems Incorporated
• Original Assignee: Drug Delivery Systems Incorporated
• Inventors: Lavi, Gilad, Gross, Joseph
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/031,335
• Time in Patent Office: 635 Days
• Field of Search: 604/20, 607/115, 607/145, 607/152, 607/153
• US Class Current: 604/20
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0448 Drug reservoir
• 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

Abstract

An iontophoretic drug delivery device comprising a flexible reservoir sandwiched between a flexible printed circuit board and a pair of flexible electrodes. A rigid top cover is mounted on a spine on the reservoir by means of snap-fit connections. The rigid cover protects the device from damage while the flexible reservoir, circuit board and electrodes can conform to the skin of a subject. The configuration of the flexible elements allows the manufacturing process to be simplified considerably, resulting in a less expensive device with ease of fabrication.

Claims

1. An iontophoretic drug delivery device, comprising:

(a) a flexible reservoir having opposed first and second surfaces and comprising at least one reservoir well adapted to contain a drug to be delivered to a subject in need thereof;

(b) a flexible, substantially flat, delivery electrode disposed on the first surface of the flexible reservoir;

(c) a flexible circuit board disposed on the second surface of the flexible reservoir and comprising means for controlling iontophoretic delivery of the drug; and

(d) a rigid protective cover positioned such that the flexible circuit board is between the flexible reservoir and the rigid protective cover, the rigid protective cover extending laterally sufficiently to cover and thereby protect the flexible circuit board and the at least one reservoir well.

2. The device according to claim 1, wherein the rigid protective cover is attached to the second surface of the flexible reservoir by mounting means, the flexible circuit board being shaped to accommodate the mounting means.

3. The device according to claim 2, wherein the mounting means comprises complementary formations on the rigid protective cover and on the flexible reservoir.

4. The device according to claim 3, wherein the flexible reservoir is provided with a substantially rigid section which carries the complementary formations on the flexible reservoir.

5. The device according to claim 4, wherein the substantially rigid section is disposed along a line separating two or more flexible sections of the flexible reservoir, each of the flexible sections comprising a separate reservoir well of the flexible reservoir.

6. The device according to claim 1, wherein the flexible circuit board and the flexible delivery electrode form part of a single flexible structure shaped to accommodate the flexible reservoir between the flexible circuit board and the flexible delivery electrode.

7. The device according to claim 1, further comprising a flexible counter-electrode disposed on the first surface of the flexible reservoir adjacent to the flexible delivery electrode.

8. The device according to claim 7, wherein each electrode is in the form of a polymeric film coated with electrically-conductive material.

9. The device according to claim 1, wherein the means for controlling iontophoretic delivery of the drug comprises means for detecting application of the device to the skin of the subject and means for commencing delivery of the drug from the at least one reservoir well upon or at a predetermined time period after said detection of application to the skin.

10. The device according to claim 9, wherein the means for detecting application of the device to the skin comprises a skin contact sensor in electrical communication with a power source, and wherein the means for commencing delivery of the drug comprises a switch which is activated upon or at a predetermined time period after detection of skin contact by the skin contact sensor.

11. The device according to claim 1, wherein the means for controlling iontophoretic delivery of the drug comprises means for increasing a current from an initial value of zero before commencement of delivery of the drug to a first value which is higher than a steady-state value, maintaining the current at the first value for a predetermined amount of time, decreasing the current to the steady-state value, and maintaining the current at the steady-state value.

12. The device according to claim 11, wherein the time taken to increase the current from zero to the first value is from 2 minutes to 30 minutes, and the current is maintained at the first value for between 10 minutes and 3 hours.

13. The device according to claim 12, wherein the time taken to increase the current from zero to the first value is from 5 minutes to 15 minutes, and the current is maintained at the first value for between 30 minutes and 2 hours.

14. The device according to claim 11, wherein the first value is between 1.5 times and 10 times the steady-state value.

15. The device according to claim 14, wherein the first value is between 1.5 times and 4 times the steady-state value.

16. The device according to claim 11, wherein the first value is 0.75 to 1.0 mA, the steady-state value is 0.25 to 0.50 mA, the time taken to increase the current from zero to the first value is 8 to 12 minutes, and the current is maintained at the first value for 45 to 60 minutes before being decreased to the steady-state value.

17. The device according to claim 1, wherein the means for controlling iontophoretic delivery of the drug comprises means for controlling a current through a programmed routine, means for detecting application and removal of the device from the skin of the subject, and means for interrupting programmed routine upon detection of removal of the defice from the skin of the subject and for recommencing the programmed routine at the point of interruption upon detection of application of the device to the skin.

18. The defice according to claim 17, wherein the means for interrupting and recommencing the programmed routine is inoperative for an initial period of up to 10 minutes after detection of application to the skin.

19. The device according to claim 18, wherein the initial period is 5 minutes or less.

20. The device according to claim 19, wherein the initial period is 3 minutes or less.

21. A method of manufacturing an iontophoretic drug delivery device, comprising the steps of:

(a) interposing a flexible circuit board between a rigid protective cover and a flexible reservoir having at least one reservoir well, the rigid protective cover and the flexible reservoir being provided with complementary formations for attachment together and said flexible circuit board being shaped to allow said complementary formations to attach together;

(b) joining the complementary formations together such that the flexible circuit board is held in place between the rigid protective cover and the flexible reservoir, and the rigid protective cover extends laterally sufficiently to cover and thereby protect the flexible circuit board and the at least one reservoir well; and

(c) providing a flexible, substantially flat delivery electrode on a surface of the flexible reservoir distal from the flexible circuit board.

22. The method according to claim 21, wherein step (c) comprises adhering the flexible delivery electrode to the flexible reservoir with an electrically conductive adhesive.

23. The method according to claim 21, wherein the flexible circuit board and the flexible delivery electrode are provided as a single flexible structure shaped to accommodate the flexible reservoir between the flexible circuit board and the flexible delivery electrode.

24. The method according to claim 21, further comprising the step of covering an exposed surface of the flexible reservoir distal from the circuit board, an exposed surface of the delivery electrode distal from the circuit board, or both, with an adhesive layer.

25. The method according to claim 24, further comprising the step of covering said adhesive layer with a release liner which is adapted to be peeled away before use of the device, so as to expose said delivery electrode and said adhesive layer.

26. The method according to claim 21, further comprising the step of filling the reservoir well with a drug to be delivered.

27. The method according to claim 26, wherein the flexible reservoir comprises a plurality of reservoir wells and the filling step involves filling different reservoir wells with different drugs.

28. An iontophoretic drug delivery device comprising:

(a) flexible reservoir means having opposed first and second surfaces;

(b) a flexible substantially flat delivery electrode carried on the first surface of the flexible reservoir means;

(c) control means comprising an electrical circuit carried on a flexible circuit board mounted on the flexible reservoir means adjacent the second surface thereof; and

(d) a rigid protective cover mounted such that the circuit board is positioned between the reservoir means and the protective cover the rigid protective cover being mounted on the reservoir means by mounting means, said mounting means being effective to hold the circuit board in position between the reservoir means and the cover and comprising complementary formations carried on the rioid cover and on the flexible reservoir means, respectively. said circuit board being shaped to accommodate the mounting means,

wherein the flexible reservoir means is provided with a substantially rigid section which engages the formations forming part of the mounting means and wherein the substantially rigid section is disposed along a central line separating two or more flexible sections, each of the flexible sections being a separate reservoir forming part of the flexible reservoir means.

29. The device according to claim 28, wherein the flexible circuit board and the flexible delivery electrode form part of a single flexible structure shaped to accommodate the flexible reservoir means between the flexible circuit board and the flexible delivery electrode.

30. The device according to claim 28, further comprising a flexible counter-electrode disposed on the first surface of the flexible reservoir means adjacent to the flexible delivery electrode.

31. The device according to claim 28, wherein each electrode is in the form of a polymeric film coated with electrically-conductive material.

32. The device according to claim 28, wherein the control means comprises means for detecting application of the device to the skin of a subject and means for commencing delivery of a drug from the reservoir means well upon detection of application of the device to the skin.

33. The device according to claim 32, wherein the means for detecting application of the device to the skin comprises a skin contact sensor connected to a power source, and wherein the means for commencing delivery of the drug comprises a switch which is activated upon detection of skin contact by the skin contact sensor.

34. The device according to claim 28, wherein the control means comprises means for increasing a current from an initial value of zero before commencement of delivery of a drug to a first value which is higher than a steady-state value, maintaining the current at the first value for a predetermined amount of time, decreasing the current to the steady-state value, and maintaining the current at the steady-state value.

35. The device according to claim 28, wherein the control means comprises means for controlling a current through a programmed routine, means for detecting application and removal of the device from the skin of a subject, and means for interrupting the programmed routine upon detection of removal of the device from the skin of the subject and for recommencing the programmed routine at the point of interruption upon detection of application of the device to the skin.

36. The device according to claim 35, wherein the means for interrupting and recommencing the program routine is inoperative for an initial period of up to 10 minutes after detection of application the skin.