Operational status for active transdermal medicament patch

• US 20090186072A1
• Filed: 01/18/2008
• Published: 07/23/2009
• 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.
• Granted Patent: US 8,862,223 B2
• Time in Patent Office: Days
• US Class Current: 424/449
• 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 a therapeutic face configured for releasable retention against the skin of a patient;

(b) a planar medicament matrix secured to said therapeutic face of said substrate interior the periphery thereof, said medicament matrix being susceptible to permeation by medicament, and said medicament matrix effecting electrically conductive engagement with the skin of the patient when said substrate is retained thereupon;

(c) a return electrode on the same side of said substrate as said medicament matrix interior said periphery of said therapeutic face, said return electrode effecting electrically conductive engagement with the skin of the patient when said substrate is retained thereupon;

(c) a power source carried on said substrate and being so electrically coupled between said medicament matrix and said return electrode as to cause iontophoretic migration of medicament from said medicament matrix into the skin of the patient; and

(d) dosage control means carried non-removably on said substrate for limiting to a predetermined medicament quantity the total medicament migrated iontophoretically from said medicament matrix into the skin of the patient during a plurality of temporally non-contiguous therapy subsessions.

2. A medicament patch as recited in claim 1, wherein said dosage control means comprises a medicament migration detector, said medicament migration detector monitoring iontophoretic medicament migration from said medicament matrix into the skin of the patient and producing as an output a continuous measure of the actual rate of said iontophoretic medicament migration.

3. A medicament patch as recited in claim 2, wherein said dosage control means further comprises:

(a) a dosage integrator operating on said output of said medicament migration detector and producing as an output a running cumulative total of the amount of medicament delivered by said iontophoretic migration; and

(b) a circuit breaker disabling of said power source, when said output of said dosage integrator equals said predetermined medicament quantity.

4. A medicament patch as recited in claim 2, wherein:

(a) said power source is so electrically coupled between said medicament matrix and said return electrode as to cause iontophoretic medicament migration from said medicament matrix into the skin of the patient to occur at a substantially constant rate; and

(b) said dosage control means further comprises;

(i) a timer active only when the output of said medicament migration detector exceeds a predetermined minimum rate of medicament migration; and

(ii) a circuit breaker disabling of said power source, when the duration of the activity of said timer equals the ratio of said predetermined medicament quantity divided by said substantially constant rate of iontophoretic medicament migration.

5. A medicament patch as recited in claim 2, wherein said medicament migration detector comprises an electrical current monitor coupled to said return electrode matrix and productive of an output only when electrical current through said return electrode exceeds a predetermined minimum electrical skin current.

6. A medicament patch as recited in claim 5, wherein said electrical current monitor comprises a sensing resistor electrically coupled between said return electrode and said power source.

7. A medicament patch as recited in claim 1, wherein said dosage control means comprises an open circuit detector so electrically coupled between said medicament matrix and said power source as to monitor the circuit created between said medicament matrix and said return electrode through the skin of a patient, when said substrate is retained thereupon

8. A medicament patch as recited in claim 7, wherein said open circuit detector monitors electrical current flow resistance through the skin of the patient between said medicament matrix and said return electrode, said monitor being productive of an output only when electrical current flow resistance between said medicament matrix and said return electrode is less than a predetermined maximum electrical current flow resistance.

9. A medicament patch as recited in claim 1, further comprising a switch carried on substrate, said switch permitting a user to initiate operation of said power source.

10. A medicament patch as recited in claim 1, further comprising dosing verification means carried non-removably on said substrate for confirming to a user that medicament from said medicament matrix is being delivered iontophoretically into the skin of the patient.

11. A medicament patch as recited in claim 10, further comprising a driver for said dosing verification means, said driver operating said dosing verification means in a distinct delivery confirmation mode during each of said therapy subsessions, respectively.

12. A transdermal medicament patch comprising:

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

(b) a medicament matrix secured to said therapeutic face of said substrate interior the periphery thereof, said medicament matrix effecting electrically conductive engagement with the skin of the patient when said substrate is retained thereupon;

(c) a return electrode on the same side of said substrate as said medicament matrix interior said periphery of said therapeutic face, said return electrode effecting electrically conductive engagement with the skin of the patient when said substrate is retained thereupon;

(d) a power source carried on said substrate and electrically coupled between said medicament matrix and said return electrode; and

(d) therapy status advisement means non-removably carried on said substrate and driven by said power source for communicating to a user the extent of completion of a predetermined therapy period wherein medicament is to be iontophoretically delivered from said medicament matrix into the skin of the patient.

13. A medicament patch as recited in claim 12, wherein said therapy status advisement means comprises a visual indicator.

14. A medicament patch as recited in claim 12, wherein said therapy status advisement means comprises:

(a) a light-emitting diode;

(b) a timer active during said therapy period; and

(c) a driver for said light-emitting diode, said driver causing said light-emitting diode to operate when said timer is active.

15. A medicament patch as recited in claim 14, wherein said driver causes said light-emitting diode to operate intermittently.

16. A medicament patch as recited in claim 14, wherein said therapy period comprises a sequence of non-overlapping predetermined therapy subsessions, and said driver causes said light-emitting diode to operate in a distinct delivery confirmation mode during each of said therapy subsessions, respectively.

17. A medicament patch as recited in claim 16, wherein said therapy subsessions comprise time intervals of substantially equal duration within said therapy period.

18. A medicament patch as recited in claim 16, wherein said driver causes said light-emitting diode to operate in a transition mode at the end of selected of said therapy subsessions.

19. A medicament patch as recited in claim 18 wherein said selected of said therapy subsessions comprises the final of said therapy stages.

20. A medicament patch as recited in claim 14, wherein said therapy status advisement means further comprises a medicament migration detector, said medicament migration detector monitoring actual iontophoretic migration of medicament from said medicament matrix into the skin of the patient and deactivating said timer when said iontophoretic migration is absent.

21. A medicament patch as recited in claim 20, wherein said medicament migration detector comprises an electrical current monitor coupled to said medicament matrix and productive of an output only when electrical current through said medicament matrix exceeds a predetermined minimum electrical skin current.

22. A medicament patch as recited in claim 21, wherein said electrical current monitor comprises a sensing resistor electrically coupled between said medicament matrix and said power source.

23. A medicament patch as recited in claim 20, wherein said driver causes said light-emitting diode to operate in an alarm mode when said timer is deactivated prior to the end of said therapy period.

24. 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 circuit board;

(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 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) electrode flexion means 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, in said compact state of said circuit board a portion of said attachment face in an electrode region of said circuit board located on the same side of said electrode flexion means as said electrode engages a portion of said attachment face in a power source region of said circuit board located on the same side of said electrode flexion means as said power source

25. A transdermal medicament patch as recited in claim 24, said attachment face of said circuit board is free of electrical circuit elements.

26. A transdermal medicament patch as recited in claim 24, wherein said electrode flexion means comprises an electrode hinge in said circuit board disposed along a separation axis between said electrode region of said circuit board and said power source region of said circuit board.

27. A transdermal medicament patch as recited in claim 26, wherein said electrode hinge comprises a fold in said circuit board.

28. A transdermal medicament patch as recited in claim 24, 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.

29. A transdermal medicament patch as recited in claim 28, 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.

30. A transdermal medicament patch as recited in claim 24, 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.

31. A transdermal medicament patch as recited in claim 24, wherein said circuit board is comprised of a flexible polyester film.

32. A transdermal medicament patch as recited in claim 24, wherein said electrode comprises an active electrode.

33. A transdermal medicament patch as recited in claim 24, wherein said electrode comprises a return electrode.

34. 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 configured in part for non-removable securement to said upper face of said circuit board, 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;

(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;

(f) a power source carried 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; and

(g) an adhesive between said upper face of said substrate and a portion of said attachment face in said third region of said circuit board free of said first region of said circuit board and free of said second region of said circuit board in said folded state of said circuit board.

35. A transdermal medicament patch as recited in claim 34, wherein said adhesive secures said circuit board to said upper face of said substrate in said folded state of said circuit board with said active electrode accessible from said therapeutic face of said substrate through said first electrode aperture and with said return electrode accessible from said therapeutic face of said substrate through said second electrode aperture.

36. A transdermal medicament patch as recited in claim 34, 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.

37. A transdermal medicament patch as recited in claim 34, wherein said circuit board is comprised of a flexible polyester film.

38. A transdermal medicament patch as recited in claim 34, said attachment face of said circuit board is free of electrical circuit elements.