Transdermal drug applicator

• US 4,708,716 A
• Filed: 09/16/1985
• Issued: 11/24/1987
• Est. Priority Date: 08/18/1983
• Status: Expired due to Term

• Current Assignee: Drug Delivery Systems Incorporated
• Original Assignee: Drug Delivery Systems Incorporated
• Inventors: Sibalis, Dan
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Citrin, Randy
• Application Number:
  US06/778,183
• Time in Patent Office: 799 Days
• Field of Search: 128/635, 128/639, 128/640, 128/783, 128/798, 128/799, 604/20, 604/891, 604/892, 604/896, 204/299 R, 204/301
• US Class Current: 604/20
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0448 Drug reservoir

Abstract

A transdermal drug applicator for application to a body for the migration of medicament through the skin into the blood stream of a patient embodies a plurality of reservoirs for containing the medicament. A battery which supplies a charge for the medicament in the applicator is disposed adjacent one side of the reservoirs with a side of the battery facing the reservoir for charging/driving the medicament. Also, a cover comprising an electrically conductive material partially encloses the battery and one side of the reservoir opposite that of the battery is exposed for contacting the skin. An electrical circuit is further provided for electrically connecting the battery to the cover, and the cover having a lip defining the periphery of the applicator for making contact with the skin when mounted on the skin leaving the battery and reservoir generally fully enclosed. An electrically conductive adhesive material coating is disposed on the underside of the lip, said reservoir renders the applicator conformable to the body contours of the patient, and when the applicator is adhered to and mounted on the skin a complete electrical circuit through the skin is formed and the medicament in the reservoir migrates out of the reservoir and through the skin into the patient'"'"'s blood stream.

Claims

1. A transdermal drug applicator for application to the body for migration of medicament through the skin to the blood stream of a patient comprising:

reservoir means containing at least one medicament, battery means for supplying a current to said applicator and being close to said reservoir means for charging/driving the medicament, means for covering comprising an electrically conductive material for partially enclosing at least said reservoir means leaving the side of said reservoir means opposite that of said battery means exposed for contacting said skin, means for electrically connecting the battery means to the cover means, said cover means having lip means for making contact with said skin when mounted on said skin leaving at least said reservoir means substantially fully enclosed, an electrically conductive adhesive material coating disposed on a side of said lip means in contact with the skin when in use, and a sensing electrode and circuit means in a feedback loop mounted on said skin when in use and connected with said electrical circuit for sensing a predetermined chemical in said body and providing a control signal for regulating drug dosage at a desired level, said applicator being generally conformable to the body contour of said patient, whereby when said applicator is adhered to and mounted on said skin a complete electrical circuit through said skin is formed and a medicament in said reservoir means migrates out of said reservoir means and through said skin into the blood stream of said patient, due to the mass transfer activity attributed to at least one phenomena selected from the group consisting of electrophoresis and electro-osmosis.

2. The transdermal drug applicator of claim 1, in which said reservoir means is made from a microporous material whereby said medicament provides an electrical path therethrough.

3. The transdermal drug applicator of claim 2, said circuit having means to maintain constant current flow during the period said medicament is being delivered.

4. The transdermal drug applicator of claim 3, wherein said circuit having means to terminate deposition of said medicament after a predetermined quantity of medicament is delivered.

5. The transdermal drug applicator of claim 1, including a plurality of reservoir means forming separate cell-like reservoirs for said medicament, and each said reservoir cell embodies the same structural layered elements so as to individually charge said medicament by said battery means for causing the migration of said medicament in said reservoir cells through said skin and into the patient'"'"'s blood stream.

6. The transdermal drug applicator of claim 5, wherein said applicator is divided into a plurality of sections, each with battery means, and said sections being connected together at least at one point, whereby said applicator may be conformable to said body contours.

7. The transdermal drug applicator of claim 6, including parallel electrical circuit paths for the electrical circuit of said applicator.

8. The transdermal drug applicator of claim 6, wherein said sections are generally all equal in size and shape.

9. The transdermal drug applicator of claim 8, wherein each said section is provided with at least one reservoir cell.

10. The transdermal drug applicator of claim 9, wherein a plurality of reservoir cells form each said section and the number of reservoir cells of said sections are the same.

11. The transdermal drug applicator of claim 10, wherein the shape of each reservoir cell is the same.

12. The transdermal drug applicator of claim 10, wherein the shapes of said reservoir cells are not all the same.

13. The transdermal drug applicator of claim 1, wherein said extra electrode is enclosed by said cover means and is disposed at said lip means.

14. The transdermal drug applicator of claim 13, wherein said extra electrode comprising a probe having a predetermined ion specific electrode or enzyme coating on the surface of said electrode portion which is in contact with the skin of said patient.

15. The transdermal drug applicator of claim 14, wherein said extra electrode is disposed in said lip means so as not to electrically interfere with the electrical circuitry of said applicator.

16. The transdermal drug applicator of claim 15, wherein said distance is such that said lip means extends outwardly and protrudes beyond the basic shape and configuration of said applicator.

17. The transdermal drug applicator of claim 1, including one or more buffers in said medicament for maintaining the pH value of the medicament at an optimal level.

18. The transdermal drug applicator of claim 17, wherein the pH of said medicament prior to application of said applicator to one'"'"'s skin is predetermined at a value which maximizes the shelf life of said drug contained in said applicator, and whereby upon application of said applicator to one'"'"'s skin the current induced pH change brings the pH within the range of said one or more buffers, thus optimizing drug mobility.

19. The transdermal drug applicator of claim 1, including a plurality of reservoir means.

20. The transdermal drug applicator of claim 19, wherein said applicator transdermally delivers a plurality of drugs and said plurality of reservoir means contain different medicaments, and the delivery of each of said medicaments, is independently controlled by at least one means selected from the group consisting of a current regulating means and a chemical regulating means.

21. The transdermal drug applicator of claim 19, wherein said controlling means is a solid state device pre-programmed for current and time.

22. The transdermal drug applicator of claim 19, further including means for releasing said different medicaments transdermally in a predetermined sequence,

23. The applicator according to claim 1, wherein said feedback loop includes an amplifier, and said feedback loop controls the duration of the on and off periods of the oscillations of said amplifier.

24. The applicator according to claim 23, wherein the duration of the on and off periods of the oscillating amplifier are independently adjustable.