Electrokinetic delivery system for self-administration of medicaments and methods therefor

• US 8,352,024 B2
• Filed: 03/13/2006
• Issued: 01/08/2013
• Est. Priority Date: 03/10/2000
• Status: Expired due to Term

• Current Assignee: HG Medical Technologies, LLC (Henley Ion, LLC)
• Original Assignee: Nitric Biotherapeutics, Inc.
• Inventors: Henley, Julian L., Chang, Kuo Wei, Potter, Joseph, Goldberg, Dennis I., Derouin, James
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Anderson, Michael J
• Application Number:
  US11/373,301
• Publication Number:
  US 20060167403A1
• Time in Patent Office: 2,493 Days
• Field of Search: 604/20, 604/19, 604/21, 607/140, 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 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• 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 electrokinetic delivery system for personal use in self-administration of a medicament to a treatment site on an individual includes a device shaped to conform with the shape of a portion of an individual'"'"'s finger from a tip thereof to a location past the first finger joint. A self-contained power source is carried by the device and a first electrode is carried by the device adjacent a distal end portion thereof and the tip of the individual'"'"'s finger. The first electrode is in electrical contact with the power source. A second electrode is carried by the device for contact with the individual'"'"'s finger. The second electrode is in electrical contact with the power source. Upon application of the first electrode over a treatment site with the medicament disposed between the first electrode and the treatment site and completion of an electrical circuit through the individual'"'"'s body and said electrode, the device applies current for electrokinetically driving the medicament into the treatment site.

Claims

1. A method of treatment by electrokinetic self-administration of a medicament into a facial treatment site of a face of an individual comprising:

(a) providing a face mask applicator having a self-contained power supply, a first electrode on one side of the face mask applicator and a ground electrode on said one side of the face mask applicator spaced from the first electrode, said first electrode, said ground electrode and said power supply being electrically coupled to one another, wherein the first electrode is a plurality of first electrodes arranged in an array on the one side of the face mask applicator;

(b) applying the face mask applicator to the facial treatment site with the first electrode overlying the facial treatment site and the ground electrode spaced from the facial treatment site in electrical contact with the individual'"'"'s face;

(c) completing an electrical circuit through a portion of the individual'"'"'s body, medicament or a carrier therefor interposed between the first electrode and the treatment site, the first electrode and the ground electrode, thereby to electrokinetically drive the medicament into the treatment site; and

(d) controlling a level of current applied to a first of the plurality of first electrodes separately from controlling the level of current applied to a second of the plurality of first electrodes, wherein the controlling includes adjusting the level of current when the level of current to the second of the plurality of first electrodes exceeds a threshold current level such that current is applied simultaneously to the first of the plurality of first electrodes is at a higher level than the current applied to the second of the plurality of first electrodes.

2. A method according to claim 1 including releasably adhesively securing the face mask applicator to the individual'"'"'s face at a location adjacent the facial treatment site.

3. A method according to claim 1 including providing a pad on the face mask applicator on said one side thereof containing the medicament and providing an electrical path from the first electrode through the medicament carried by the face mask applicator to the facial treatment site.

4. A method according to claim 3 including providing hydration fluid carried by said pad between the first electrode and the facial treatment site, enabling the hydration fluid to carry the medicament into the facial treatment site upon activation of the electrical circuit.

5. A method according to claim 1 wherein step (a) includes stacking a medicament, said first electrode, said self-contained power supply, said ground electrode and at least one of a tacky substance or an electrically conductive material between opposite sides of the face mask applicator in registration one with the other.

6. A method according to claim 1 including releasably securing the face mask applicator to the individual'"'"'s face at a location adjacent the facial treatment site.

7. A method of treatment by electrokinetic self-administration of a medicament into a facial treatment site for an individual comprising:

a. providing a facemask applicator having a self-contained power supply, a first electrode electrically coupled to the power supply and a second electrode electrically coupled to the power supply, wherein the first and second electrode are arranged on a surface of the facemask applicator to be applied to facial skin including the facial treatment site;

b. applying the surface of the facemask applicator to the facial treatment site, wherein the facemask applicator includes a medicament between the facial treatment site and the first electrode;

c. establishing a second electrical connection between the second electrode and a second site on the facial skin spaced from the facial treatment site, wherein the second site is covered by the surface of the facemask applicator;

d. completing an electrical circuit including the power supply, the first electrode, the medicament, the facial treatment site, the second site, and the second electrical connection to electrokinetically drive the medicament into the facial treatment site, and

e. controlling a level of current applied to one of the plurality of first electrodes separately from controlling the level of current applied to another one of the plurality of first electrodes, wherein the controlling includes reducing the level of current when the level of current to the one of the plurality of first electrodes exceeds a threshold current level while continuing to apply a higher level of current to another one of the plurality of first electrodes wherein the reduced level of current is not an absence of current.

8. A method according to claim 7 wherein the second electrical connection is a ground connection.

9. A method according to claim 7 including releasably adhesively securing the facemask applicator to the individual'"'"'s face at a location adjacent the facial treatment site.

10. A method according to claim 7 including providing a pad on the facemask applicator on said one side thereof containing the medicament and providing an electrical path from the first electrode through the medicament carried by the facemask applicator to the facial treatment site.

11. A method according to claim 10 including providing hydration fluid carried by said pad between the first electrode and the facial treatment site, enabling the hydration fluid to carry the medicament into the facial treatment site upon activation of the electrical circuit.

12. A method according to claim 7 wherein step (a) includes stacking a medicament, said first electrode, said self-contained power supply, said ground electrode and at least one of a tacky substance or an electrically conductive material between opposite sides of the facemask applicator in registration one with the other.

13. A method of treatment by electrokinetic self-administration of a medicament into a facial treatment site of a face of an individual using an applicator device having a self-contained power supply, a plurality of first electrodes on a first side of a face mask and a second electrode, wherein said first electrodes, said second electrode and said power supply being electrically coupled to one another in a circuit including the individual, and said plurality of first electrodes are connected to an array of individually electrically conductive channels, wherein said method comprises:

applying the face mask to the facial treatment site with the plurality of first electrodes overlying the facial treatment site and a medicament between the first electrodes and the facial treatment site;

applying the second electrode to a location on the individual spaced from the facial treatment site and in electrical contact with the individual;

completing an electrical circuit through the portion of the individual'"'"'s body, the medicament or a carrier therefor interposed between the plurality of first electrodes and the treatment site, the plurality first electrode and the second electrode, to electrokinetically drive the medicament into the treatment site, and

controlling electrical current applied to one or more of the individually electrically conductive channels separately from controlling the electrical current applied to another one or more of the individually electrically conductive channels, wherein separately controlling the electrical current includes adjusting the current to the one of the plurality of first electrodes when the current to the one of the plurality of first electrodes exceeds an error level, wherein the adjusted current is a non-zero level of current.

14. The method of claim 13 wherein the plurality of first electrodes are distributed over a wide area of the first side of the face mask.

15. The method of claim 13 wherein each first electrode corresponds to one of the individual electrically conductive channels.

16. The method of claim 13 further comprising separately controlling each of the individually electrically conductive channels.

17. The method of claim 16 further comprising separately controlling the channels to prevent tunneling of current through the first electrodes and into the facial treatment site.

18. The method of claim 13 wherein the channels each include a lead wire electrically coupled to a corresponding first active electrode.

19. The method of claim 13 wherein said face mask includes a substrate including the medicament and said method further comprises applying a first side of said substrate to the facial treatment site and the step of completing the electrical circuit includes applying electrical current to an opposite side of the substrate to deliver the medicament to the facial treatment site.

20. The method of claim 19 wherein the substrate includes honeycomb cells and the step of controlling the application of current includes delivering medicament from the cells to areas of the facial treatment site underlying each cell.

21. A device for electrokinetic self-administration of a medicament into a facial treatment site of an individual, said device comprising:

a power supply;

a facemask having an inside surface including a plurality of first electrodes;

individually electrically conductive channels each connected or connectable to each of the plurality of first electrodes, wherein at least one channel is controlled to apply a current to a corresponding first electrode at current level different than current applied by another channel to a corresponding another first electrode;

a medicament matrix supported by the face mask and to be interposed between the plurality of first electrodes and the facial treatment site;

a counter electrode, and

a control circuit controlling the current applied to electrically conductive channels,

wherein said medicament matrix, first electrodes, electrically conductive channels, said counter electrode and said power supply being electrically coupled to one another in a circuit including the individual, and in said completing the electrical circuit, electrical current flows to one or more of the individually electrically conductive channels separately of current flowing to another one or more of the individually electrically conductive channels, and

wherein the control circuit separately controls the electrical current applied to one of the channels when the current in the channel exceeds a predetermined error level wherein the control circuit applies different levels of current to at least two different first electrodes, wherein the different levels of current are each non-zero current levels.

22. The device of claim 21 wherein the plurality of first electrodes are distributed over a wide area of the first side of the face mask.

23. The device of claim 21 wherein each of said plurality of first electrodes corresponds to one of the individually electrically conductive channels.

24. The device of claim 21 further comprising electronics coupled to the power supply and individually electrically conductive channels, and said electronics separately controlling current applied to the individually electrically conductive channels and corresponding first electrodes.

25. The device of claim 24 wherein the electronics separately controls each of the channels to prevent tunneling of current through the array and into the facial treatment site.

26. The device of claim 21 wherein the individually electrically conductive channels each include a lead wire electrically coupled to a corresponding first electrode.

27. The device of claim 21 wherein said face mask includes a substrate including the medicament.

28. The device of claim 21 wherein the substrate includes honeycomb cells and the step of applying electrical current includes delivering medicament from the cells to areas of the facial treatment site underlying each cell.

29. A method of treatment by electrokinetic self-administration of a medicament into a facial treatment site of a face of an individual comprising:

(a) providing a face mask applicator having a self-contained power supply, a plurality of first electrodes on one side of the face mask applicator and a ground electrode on said one side of the face mask applicator spaced from the first electrode, said first electrode, said ground electrode and said power supply being electrically coupled to one another, wherein the first electrode is a plurality of first electrodes arranged in an array on the one side of the face mask applicator;

(b) applying the face mask applicator to the facial treatment site with a plurality of the first electrode overlying the facial treatment site and the ground electrode spaced from the facial treatment site in electrical contact with the individual'"'"'s face;

(c) establishing an isolated, individual electrical conductive channel to each of the plurality of the first electrodes;

(d) for each of the isolated, individual electrical conductive channels and its corresponding first electrode, forming a current carrying circuit including the power supply, channel, the first electrode, a portion of a body of the individual and the ground electrode;

(e) applying current to the current carrying circuit to electrokinetically drive into the facial treatment site medicament or a carrier for the medicament from a matrix between the plurality of first electrodes and the facial treatment site, and

(d) applying a level of non-zero current applied to one of the isolated, individual electrical conductive channels and applying a different level of nonzero current to a different one of the isolated, individual electrical conductive channels.

30. The method of treatment in claim 29 wherein the applying of the levels of current includes adjusting the current when a level of current to the one of the plurality of first electrodes exceeds a threshold current level.