Programmable control and mounting system for transdermal drug applicator

• US 5,135,479 A
• Filed: 06/06/1991
• Issued: 08/04/1992
• 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, Rosen, Sanford
• Primary Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US07/711,589
• Time in Patent Office: 425 Days
• Field of Search: 128/419 R, 128/635, 128/666, 128/690, 128/798, 128/802, 128/803, 604/20
• US Class Current: 604/20
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• 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 1/0444 Membrane
• CPC Class Codes: A61N 1/0448 Drug reservoir

Abstract

A transdermal drug applicator (100) for application to a living body for the delivery of at least one drug through the skin (144) into the bloodstream comprising an applicator (100) including at least one drug reservoir (182A, 182B) containing the drug for delivering same through the skin (144) by physico/chemical mass transfer. A mounting structure (138, 140) is removably mounted to the body for holding the applicator (100) to the skin (144), with the applicator (100) removably connected to the mounting structure (138, 140). A power supply (166) for the applicator (100) and a circuit transmitting electrical power from the power supply (166) to the applicator (100) is disclosed, wherein an electric circuit is created between the applicator (100) and the skin (144). The device includes a computer (158) with the mounting structure (138,140) for receiving programmed instructions relative to the drug, and transmitting signals relative to the drug and the programmed instructions to the power supply (166) for regulating the generation of power and delivery of drug through the skin (144).

Claims

1. A transdermal drug applicator for application to a living body for the delivery of at least one drug through the skin or the like into a body comprising:

at least one drug reservoir containing at least one drug for delivering the at least one drug through the skin by a physico/chemical mass transfer of the at least one drug;

flexible mounting means in the form of a strap removably holding said at least one drug reservoir to the skin when in use and forming together with said at least one drug reservoir a conformal assembly adapted to be conformed to that part of said body to which said transdermal drug applicator is attached;

power means for supplying power to and associated with said at least one drug reservoir;

circuit means for transmitting electrical power received from said power means to said at least one drug reservoir wherein an electric circuit is created between said applicator and said power means through the skin; and

computer means associated with said mounting means for receiving programmed instructions relative to the at least one drug and for transmitting signals regarding the at least one drug and said programmed instructions to said power means for regulating the generation of power delivery of the at least one drug through the skin;

whereby said strap facilitates the secure attachment of said transdermal drug applicator to said body and provides support means for the at least one drug reservoir.

2. The transdermal drug applicator according to claim 1, further including sensing means for measuring body changes and directly inputting said body changes to said computer means, so that said power means can be regulated by said computer means according to said body changes.

3. The transdermal drug applicator according to claim 2, wherein said sensing means includes means capable of detecting at least one body parameter, either directly or indirectly, at a skin interface with said applicator, taken from the group comprising skin temperature, skin conductivity, pulse rate and capillary dialation.

4. The transdermal drug applicator according to claim 1, further including elongated first and second spaced flexible electrodes positioned in said circuit means, said first electrode being positioned within said at least one drug reservoir, with said second electrode and said skin being in electrical communication when the drug applicator is in use.

5. The transdermal drug applicator according to claim 4, including a first electrical connection means between said first electrode and said computer means;

and a second electrical connection means between said computer means and said second electrode.

6. The transdermal drug applicator according to claim 5, wherein said at least one drug is in the form of a drug loaded solution which is electrically conductive, said at least one drug reservoir being porous so as to permit migration of said drug loaded solution.

7. The transdermal drug applicator according to claim 4, further including sensing means associated with said mounting means monitoring chemical and physical changes in said skin, so as to input said changes to said computer means;

and also further including adhesive means for removably securing and holding said applicator and said sensing means to said mounting means, whereby electrical connections are directly maintained between said first and second electrodes and said computer means and said sensing means and said computer means.

8. The transdermal drug applicator according to claim 1, including means for maintaining proper electrical contact between said skin and said applicator.

9. The transdermal drug applicator according to claim 8, wherein said means for maintaining proper electrical contact is a conductive adhesive.

10. The transdermal drug applicator according to claim 8, wherein said means for maintaining proper electrical contact is a biasing element in said mounting means capable of maintaining proper electrical control between said skin and said applicator means.

11. The transdermal drug applicator according to claim 1, wherein said computer means includes a case attached to said mounting means, a memory, display means and a computer power source positioned in said case.

12. The transdermal drug applicator according to claim 11, including sensing means associated with said mounting means for monitoring chemical and physical changes in said skin so as to input said changes to said computer means, said computer means being in electrical connection with said sensing means.

13. The transdermal drug applicator according to claim 11, wherein said display means is an LCD.

14. The transdermal drug applicator according to claim 13, wherein said computer means includes elements for monitoring time.

15. The transdermal drug applicator according to claim 11, wherein said computer means further includes elements for displaying data relative to drug delivery.

16. The transdermal drug applicator according to claim 15, further including an electrical connection between said computer means and said power source, said computer means being capable of controlling the power delivered by said power source.

17. The transdermal drug applicator according to claim 1, further including independent sensing means for sensing physical and chemical changes at said skin, and being in electrical connection with said computer means.

18. The transdermal drug applicator according to claim 17, wherein said independent sensing means includes a heart-monitoring device, said heart-monitoring device including a light tube means and an LED positioned over said light tube means, and said LED being in electrical connection with said computer means wherein light reflected from said skin via said tube means to said LED is sensed by a photocell and the variations of the reflected light are used to compute a pulse rate.

19. The transdermal drug applicator according to claim 1, wherein said mounting means is a strap adapted to support a watch.

20. The transdermal drug applicator according to claim 1, wherein said applicator is disposed between said mounting means and said skin when in use.

21. The transdermal drug applicator according to claim 20, wherein said applicator is disposed about a centrally disposed mounting means for contacting a mucous membrane.

22. The transdermal drug applicator according to claim 1, wherein said mounting means is external with respect to said applicator so as to generally cover said applicator upon being wrapped about a limb or other portion of a body.

23. The transdermal drug applicator according to claim 1, further including current conditioning means connected serially to said power means to provide a constant current.

24. The transdermal drug applicator according to claim 1, wherein said computer means includes timing means for controlling the frequency, duration and number of times in which delivery and cessation of delivery of a drug by the applicator is at a controlled rate.

25. An electrokinetic transdermal drug applicator having a plurality of drug reservoirs adapted to be adhered to the skin of a subject at an interface between said skin and said plurality of drug reservoirs comprising:

a plurality of electrodes and a power source for providing the movement of a drug through the skin of said subject by means of electrokinetic phenomena; and

a plurality of buffering means with a predetermined amount of each said buffering means in said drug reservoirs, and each said buffering means having a different pH range for controlling the drug delivery rates for predetermined time intervals;

whereby the exhaustion of said predetermined amount of said at least one buffering means in said drug reservoirs changes the rate of drug delivery, so that said buffering means performs the function of sequential timing.