Active transdermal medicament patch and circuit board for same

• US 8,862,223 B2
• Filed: 01/18/2008
• Issued: 10/14/2014
• Est. Priority Date: 01/18/2008
• Status: Active Grant

• Current Assignee: ActivaTek Inc. (North Coast Medical, Inc.)
• Original Assignee: ActivaTek Inc. (North Coast Medical, Inc.)
• Inventors: Yanaki, Jamal S.
• Primary Examiner(s): Berdichevsky, Aarti B
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US12/009,443
• Publication Number:
  US 20090186072A1
• Time in Patent Office: 2,461 Days
• Field of Search: 604/20, 604/890.1, 604/891.1, 604/892.1, 424/449
• US Class Current: 604/20
• CPC Class Codes: A61K 9/7023 Transdermal patches and similar drug-containing composite devices, e.g. cataplasms galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006
• 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
• 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 active transdermal medicament patch includes a planar substrate with a therapeutic face releasably retainable against the skin of a patient. A return electrode and a medicament matrix susceptible to permeation by medicament are secured at separated locations on the therapeutic face and electrically conductively engage the skin. A detector monitors iontophoretic medicament migration into the skin. An integrator operating on the output of the detector produces a running cumulative total of the amount of medicament delivered during a plurality of temporally non-contiguous therapy subsessions. A circuit breaker terminates medicament migration, when the output of the integrator equals a predetermined medicament quantity. A timer active during medicament migration stimulates a driver to operate a light-emitting diode in a distinct delivery confirmation mode during each a sequence of non-overlapping predetermined therapy subsessions, respectively. A circuit board on the substrate in a compact, folded state bears interconnected electrical circuit components.

Claims

1. A transdermal medicament patch comprising:

(a) a flexible, planar biocompatible substrate having on one side thereof an upper face and on the other side thereof a therapeutic face configured for releasable retention against the skin of a patient;

(b) a circuit board carried on said upper face of said substrate, said circuit board having on one side thereof a support face and on the other side thereof an attachment face, a portion of said attachment face of said circuit board being non-removably secured to said upper face of said substrate;

(c) a printed circuit on said support face of said circuit board;

(d) a power source mounted directly on said support face of said circuit board;

(e) an electrode carried on said support face of said circuit board, said electrode being electrically coupled to said power source by said printed circuit; and

(f) an electrode hinge traversing said circuit board intermediate said electrode and said power source for permitting bending of said circuit board between;

(i) a planar state of said circuit board; and

(ii) a compact state of said circuit board, wherein a portion of said circuit board is folded over such that two portions of said circuit board are in planar contact with each other, wherein in said compact state of said circuit board, the periphery of said circuit board assumes the shape of a barbell, said barbell having enlarged ends interconnected by an intermediate portion narrower in extent than the ends.

2. A transdermal medicament patch as recited in claim 1, said attachment face of said circuit board is free of electrical circuit elements.

3. A transdermal medicament patch as recited in claim 1, wherein said electrode hinge comprises a fold in said circuit board.

4. A transdermal medicament patch as recited in claim 1, wherein said circuit board is secured to said upper face of said substrate by an adhesive between said upper face of said substrate and a portion of said attachment face of said circuit board free of said electrode region of said circuit board in said compact state of said circuit board.

5. A transdermal medicament patch as recited in claim 4, wherein an electrode aperture is formed through said substrate;

and said adhesive secures said circuit board to said upper face of said substrate in said compact state of said circuit board with said electrode accessible from said therapeutic face of said substrate through said electrode aperture.

6. A transdermal medicament patch as recited in claim 1, wherein an electrical circuit element is carried on said support face of said power source region of said circuit board, and said electrical circuit element is electrically coupled to said power source by said printed circuit.

7. A transdermal medicament patch as recited in claim 1, wherein said circuit board is comprised of a flexible polyester film.

8. A transdermal medicament patch as recited in claim 1, wherein said electrode comprises an active electrode.

9. A transdermal medicament patch as recited in claim 1, wherein said electrode comprises a return electrode.

10. A transdermal medicament patch comprising:

(a) a flexible, planar biocompatible substrate having on one side thereof an upper face and on the other side thereof a therapeutic face configured for releasable retention against the skin of a patient;

(b) a circuit board carried on said upper face of said substrate, said circuit board having on one side thereof a support face and on the other side thereof an attachment face, a portion of said attachment face of said circuit board being non-removably secured to said upper face of said substrate;

(c) a printed circuit on said support face of said circuit board;

(d) a power source carried on said support face of said circuit board;

(e) an active electrode carried on said support face in a first region of said circuit board, said active electrode being electrically coupled to said power source by said printed circuit;

(f) a return electrode carried on said support face in a second region of said circuit board nonadjacent to said first region thereof, said active electrode being electrically coupled to said power source by said printed circuit; and

(g) an electrode flexion network traversing said circuit board intermediate said active electrode and said power source and between said return electrode and said power source, said electrode flexion network permitting said circuit board to assume a planar state and a folded state, in said folded state of said circuit board portions of said attachment face in each of said first region and said second region of said circuit board engaging corresponding portions of said attachment face in a third region of said circuit board intermediate said first and second regions, and wherein in said folded state of said circuit board, the periphery of said circuit board assumes the shape of a barbell, said barbell having enlarged ends interconnected by an intermediate portion narrower in extent than the ends.

11. A transdermal medicament patch as recited in claim 10, further comprising:

(a) a first electrode aperture formed through said substrate; and

(b) a second electrode aperture formed through said substrate at a location separated from the location of said first electrode aperture.

12. A transdermal medicament patch as recited in claim 11, wherein said circuit board is non-removably secured to said upper face of said circuit board in said folded state of said circuit board.

13. A transdermal medicament patch as recited in claim 12, when said circuit board is non-removably secured to said upper face of said circuit board in said folded state of said circuit board, said active electrode is accessible from said therapeutic face of said substrate through said first electrode aperture and said return electrode is accessible from said therapeutic face of said substrate through said second electrode aperture.

14. A transdermal medicament patch as recited in claim 11, wherein said enlarged ends of said barbell are smaller than said first electrode aperture.

15. A transdermal medicament patch as recited in claim 11, wherein said enlarged ends of said barbell are smaller than said second electrode aperture.

16. A transdermal medicament patch as recited in claim 11, wherein said intermediate portion of said barbell has peripheral sides defined by linear segments.

17. A transdermal medicament patch as recited in claim 11, wherein said intermediate portion of said barbell extends between said first electrode aperture and said second electrode aperture when said circuit board is non-removably secured to said upper face of said circuit board in said folded state of said circuit board.

18. A transdermal medicament patch as recited in claim 10, wherein an electrical circuit element is carried on said support face of said third region of said circuit board, and said electrical circuit element is electrically coupled to said power source by said printed circuit.

19. A transdermal medicament patch as recited in claim 10, wherein said circuit board is comprised of a flexible polyester film.

20. A transdermal medicament patch as recited in claim 10, wherein said attachment face of said circuit board is free of electrical circuit elements.

21. A transdermal medicament patch as recited in claim 10, wherein said electrode flexion network comprises:

(a) an active electrode hinge in said circuit board disposed along an active electrode separation axis between said first region of said circuit board and said power source; and

(b) a return electrode hinge in said circuit board disposed along a return electrode separation axis between said second region of said circuit board and said power source.

22. A transdermal medicament patch as recited in claim 21, wherein:

(a) said active electrode hinge comprises a first fold in said circuit board; and

(b) said return electrode hinge comprises a second fold in said circuit board.

23. A transdermal medicament patch as recited in claim 21, wherein said active electrode separation axis is parallel to said return electrode separation axis.

24. A transdermal medicament patch as recited in claim 21, wherein said active electrode separation axis is oriented generally transversely to the longitudinal extent of said circuit board.

25. A transdermal medicament patch as recited in claim 24, wherein said return electrode separation axis is oriented generally transversely to the longitudinal extent of said circuit board.

26. A transdermal medicament patch as recited in claim 24, wherein said return electrode separation axis is oriented generally transversely to the longitudinal extent of said circuit board.

27. A transdermal medicament patch comprising:

(a) a flexible, planar biocompatible substrate having on one side thereof an upper face and on the other side thereof a therapeutic face configured for releasable retention against the skin of a patient, said substrate having formed therethrough a first electrode aperture and a second electrode aperture separated therefrom;

(b) a circuit board carried on said upper face of said substrate, said circuit board having on one side thereof a support face and on the other side thereof an attachment face in part non-removably secured to said upper face of said substrate, said circuit board being capable of assuming a planar state and a folded state, in said folded state of said circuit board portions of said attachment face in each of a first region and a nonadjacent second region of said circuit board engage corresponding portions of said attachment face in a third region of said circuit board intermediate said first and second regions and wherein in said folded state of said circuit board, the periphery of said circuit board assumes the shape of a barbell, said barbell having enlarged ends interconnected by an intermediate portion narrower in extent than the ends;

(c) a printed circuit on said support face of said circuit board;

(d) an active electrode carried on said support face in said first region of said circuit board;

(e) a return electrode carried on said support face in said second region of said circuit board; and

(f) a power source mounted directly on said support face of said circuit board, said power source being electrically coupled to said active electrode and to said return electrode by said printed circuit.

28. A transdermal medicament patch as recited in claim 27, wherein in said folded state of said circuit board said active electrode is accessible from said therapeutic face of said substrate through said first electrode aperture and said return electrode is accessible from said therapeutic face of said substrate through said second electrode aperture.

29. A transdermal medicament patch as recited in claim 27, wherein an electrical circuit element is carried on said support face of said third region of said circuit board, and said electrical circuit element is electrically coupled to said power source by said printed circuit.

30. A transdermal medicament patch as recited in claim 27, wherein said circuit board is comprised of a flexible polyester film.

31. A transdermal medicament patch as recited in claim 27, said attachment face of said circuit board is free of electrical circuit elements.