Transdermal drug applicator

• US 6,129,696 A
• Filed: 05/22/1995
• Issued: 10/10/2000
• Est. Priority Date: 08/18/1983
• Status: Expired due to Fees

• Current Assignee: Drug Delivery Systems Incorporated
• Original Assignee: Drug Delivery Systems Incorporated
• Inventors: Sibalis, Dan
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/445,577
• Time in Patent Office: 1,968 Days
• Field of Search: 604/20, 607/149, 607/151
• 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 comprising at least two flexible drug reservoir units each having ends and being of a predetermined depth, and at least one medicament in at least one of the at least two reservoir units. Peripheral means are disposed entirely about the ends of the reservoir units for separating and insulating the reservoir units from each other along their predetermined depth to thereby preclude shorting out between the at least two reservoir units. Circuit means including battery means for electrically connecting the battery means to the at least two reservoir units, and means for covering the applicator including the at least two reservoir units leaving sides of the at least two reservoir units exposed for contacting the skin. The means for covering being flexible and having lip means including an underside for making contact with the skin when mounted on the skin with the at least two reservoir units substantially fully enclosed, so that when the applicator is mounted and retained on the skin, it deforms and conforms to the body in a complete electrical circuit through the skin is formed via the circuit means, and whereby the at least one medicament in at least one of the at least two drug reservoir units migrates out of the reservoir units through the skin into the blood stream of the patient by means of a mass transfer activity attributed to at least one mass transfer phenomenon selected from the group consisting of electrophoresis and electroosmosis.

Claims

1. A conformable, pliable and relatively thin transdermal drug applicator for electrophoresis or electroosmosis of at least one medicament through the skin and into the blood stream of a patient comprising:

(a) a plurality of juxtaposed flexible drug reservoir units formed with at least one medicament therein;

(b) a conformable power source coupled to said plurality of juxtaposed flexible drug reservoir units, said power source having a battery and an electrical circuit formed to provide an electrical potential to said juxtaposed drug reservoir units;

(c) a flexible, insulative and hydrophobic material surrounding said plurality of flexible drug reservoir units and said power source while leaving common sides of said plurality of flexible drug reservoir units adapted for contacting the skin, said flexible, insulative and hydrophobic material precluding shorting of said plurality of flexible reservoir units while aiding in providing flexibility to the applicator; and

(d) a flexible cover surrounding said plurality of flexible reservoir units, said power source, and said flexible insulative and hydrophobic material while leaving common sides of said plurality of flexible reservoir units adapted for contacting the skin, said flexible cover being provided with a peripheral lip formed to releaseably cooperate with the patient'"'"'s tissue such that said flexible cover is capable of compensating for movement of the skin during transdermal drug delivery, said flexible cover in combination with said plurality of flexible reservoir units, and said flexible insulative and hydrophobic material allowing said transdermal drug applicator to conform to the surface of a patient'"'"'s tissue, the conformability of the transdermal drug applicator increasing with the number of said plurality of juxtaposed flexible reservoir units and amount of said insulative and hydrophobic material provided within the transdermal drug applicator.

2. The transdermal drug applicator of claim 1, wherein at least one of said at least two drug reservoir units including a plurality of drug reservoir units.

3. The transdermal drug applicator according to claim 2, wherein at least said one of said at least two drug reservoir units is positioned on one electrical pole side of said battery means and another of said at least two drug reservoir units is positioned on the other electrical pole side of said battery means.

4. The transdermal drug applicator according to claim 2, wherein said plurality of drug reservoir units form an overall grid pattern forming at least one applicator section, (whereby said applicator may be conformable to the contours of the body).

5. The transdermal drug applicator according claim 4, wherein said at least one applicator section is configured as a rectangle.

6. The transdermal drug applicator according to claim 5, wherein said rectangle is a square.

7. The transdermal drug applicator according to claim 4, wherein said at least one applicator section is a plurality of applicator sections.

8. The transdermal drug applicator according to claim 7, wherein said plurality of applicator sections is a pair of applicator sections forming a unitary applicator.

9. The transdermal drug applicator according to claim 8, wherein said pair of applicator sections are configured as a pair of rectangles.

10. The transdermal drug applicator according to claim 8, wherein said plurality of applicator sections are configured as a pair of separate semi-ovals forming a single unitary applicator.

11. The transdermal drug applicator according to claim 4, wherein said plurality of applicator sections are configured as a plurality of petals emanating from a central area.

12. A conformable, pliable, and relatively thin transdermal drug applicator for electrophoresis or electroosmosis of at least one medicament through the skin and into the blood stream of a patient comprising:

(a) a plurality of juxtaposed flexible drug reservoir units forming a conformable network, at least one of said plurality of juxtaposed flexible drug reservoir units being configured with;

(i) at least one medicament;

(ii) a flexible circuit board having an electrical circuit and a battery, said flexible circuit board configured for electrically connecting said battery to said at least one medicament; and

(iii) a flexible, insulative and hydrophobic material surrounding said at least one medicament and said flexible circuit board while leaving a side of said medicament and said flexible drug reservoir units adapted for contacting the skin, said flexible, insulative and hydrophobic material precluding shorting of said plurality of flexible reservoir units while aiding in providing flexibility to the applicator; and

(b) a flexible cover substantially enclosing the applicator including said plurality of juxtaposed flexible reservoir units, said flexible circuit board, and said flexible insulative and hydrophobic material while leaving common sides of said plurality of juxtaposed flexible drug reservoir units adapted for contacting the skin, said flexible cover being provided with a peripheral lip formed to releaseably cooperate with the patient'"'"'s tissue while allowing the applicator to be mounted and retained on the skin, said flexible cover in combination with said plurality of flexible reservoir units and said insulative and hydrophobic material allowing said applicator to easily compensate for movement of the skin, the conformability of the transdermal drug applicator increasing with the number of said plurality of juxtaposed flexible reservoir units and amount of said insulative and hydrophobic material provided within the transdermal drug applicator, while said applicator deforming and flexing to thereby conform to the contours of the patient'"'"'s tissue and complete an electrical circuit through the skin via said flexible circuit board.

13. The transdermal drug applicator according to claim 12, wherein said reservoir units all have substantially the same structure.

14. The transdermal drug applicator according to claim 12, wherein one of said at least two reservoir units is positioned on one electrical pole side of said battery means and at least one of the other reservoir units is positioned on the other electrical post side of said battery means.

15. The transdermal drug applicator required to claim 12, wherein said lift means extends outwardly opposite applicator.

16. The transdermal drug applicator according to claim 15, said lip means extending in a plane generally paralleling a plane passing through the sides of said reservoir units exposed for contacting the skin of said patient.

17. The transdermal drug applicator according to claim 15, said lip means forming an uninterrupted peripheral zone circumscribing said applicator boundary.

18. The transdermal drug applicator according to claim 17, wherein said lip means is integrally formed with said means for covering and extends outwardly thereof forming a lateral annular flange about said applicator.

19. The transdermal drug applicator according to claim 12, wherein the shape of said reservoir units is selected from the group comprising rectangular, squarish, oval, half-oval and triangular shape.

20. A conformable, pliable, and relatively thin transdermal drug applicator for electrophoresis or electroosmosis of at least one medicament through the skin and into the blood stream of a patient comprising:

(a) a plurality of juxtaposed flexible drug reservoir units forming a cell-like network, said plurality of juxtaposed flexible drug reservoir units having at least one medicament in at least one of said plurality of juxtaposed flexible drug reservoir units;

(b) a power source coupled to said plurality of juxtaposed flexible drug reservoir units, said power source having a circuit including a battery, said circuit configured to electrically connect said battery to said at least one medicament in at least one of said plurality of juxtaposed flexible drug reservoir units;

(c) a flexible, insulative and hydrophobic material surrounding said plurality of flexible drug reservoir units and said power source while leaving common sides of said plurality of flexible drug reservoir units being adapted for contacting the skin, said flexible, insulative and hydrophobic material precluding shorting of said plurality of flexible reservoir units while aiding in providing flexibility to the applicator; and

(d) a flexible cover substantially surrounding said plurality of juxtaposed flexible drug reservoir units, said power source, and said flexible insulative and hydrophobic material while leaving common sides of said plurality of juxtaposed flexible drug reservoir units adapted for contacting the skin, said flexible cover being provided with a peripheral lip formed to releaseably cooperate with the patient'"'"'s tissue while allowing the transdermal drug applicator to be mounted and retained on the skin, said flexible cover in combination with said plurality of flexible reservoir units and said insulative and hydrophobic material allowing said applicator to easily compensate for movement of the skin, the conformability of the transdermal drug applicator increasing with the number of said plurality of juxtaposed flexible reservoir units and amount of said insulative and hydrophobic material provided within the transdermal drug applicator, while said applicator deforming and flexing to thereby conform to the contours of the patient'"'"'s body and complete an electrical circuit through the skin via said circuit to allow migration of said at least one medicament from said plurality of juxtaposed reservoir units through said skin and into the blood stream of the patient.

21. The transdermal drug applicator of claim 20, in which said plurality of reservoir means are made from a microporous material whereby said at least one medicament provides an electrical path therethrough.

22. The transdermal drug applicator of claim 21;

further including in said electrical circuit means to maintain constant current flowing during the period said at least one medicament is being delivered.

23. The transdermal drug applicator of claim 20, wherein said plurality of reservoirs are adjacently disposed.

24. The transdermal drug applicator of claim 20, wherein said plurality of reservoirs are spaced apart from each other.

25. The transdermal drug applicator of claim 20, wherein said means for separating said plurality of reservoir units from each other comprises a non-conductive hydrophobic gel.

26. The transdermal drug applicator of claim 20, wherein said plurality of reservoirs means are two.

27. The transdermal drug applicator of claim 20, wherein said overall grid pattern is configured as a rectangle.

28. The transdermal drug applicator of claim 20, wherein said overall grid pattern is configured a pair of halves.

29. The transdermal drug applicator according to claim 28, wherein each of said pair of halves is configured as a rectangle.

30. The transdermal drug applicator according to claim 28, wherein each of said pair of halves is configured as a semi-oval.

31. The transdermal drug applicator of claim 20, wherein said overall grid pattern is in the shape of a plurality of petals.