Programmable control and mounting system for transdermal drug applicator

• US 5,865,786 A
• Filed: 06/07/1995
• Issued: 02/02/1999
• Est. Priority Date: 08/18/1983
• Status: Expired due to Fees

• Current Assignee: Drug Delivery Systems Incorporated
• Original Assignee: Drug Delivery Systems Incorporated
• Inventors: Rosen, Sanford, Sibalis, Dan
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/474,252
• Time in Patent Office: 1,336 Days
• Field of Search: 604/20-21, 604/49
• 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 1/0444 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 delievery of drug through the skin (144).

Claims

1. An electrically powered transdermal drug applicator that is adapted to be adhered to the skin of an animal or human being for the controlled, automatic delivery of at least one drug through the skin or the like, comprising:

applicator means having a skin-contacting surface and including at least one drug reservoir containing at least one drug;

flexible mounting means for removably adhering said applicator means to said skin;

power means electrically connected to said at least one drug reservoir at an electrode for delivery of said at least one drug;

circuit means completing an electrical circuit between said at least one drug reservoir and said power means by return through the skin when said transdermal drug applicator is in use; and

programmable computer means associated with said mounting means for regulating the generation of power so as to provide the controlled, automatic delivery of said at least one drug through said skin.

2. The transdermal drug applicator according to claim 1, wherein said drug reservoir is coextensive with said mounting means.

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

4. The transdermal drug applicator according to claim 3, 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.

5. The transdermal drug applicator according to claim 4, wherein said at least one drug reservoir having a drug loaded solution which is electrically conductive and includes a surface permeable to the passage of said drug.

6. The transdermal drug applicator according to claim 3, further including sensing means associated with said mounting means monitoring chemical and physical changes in said skin, so as to input to 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.

7. The transdermal drug applicator according to claim 1, wherein said mounting means and said applicator means comprise unitary mounting means and applicator means.

8. The transdermal drug applicator according to claim 7, further including detachable connector means for removably securing said unitary means to said computer means.

9. The transdermal drug applicator according to claim 8, wherein said unitary means contains said power source.

10. The transdermal drug applicator according to claim 9, further including detachable electrical connecting means between said unitary means and said computer means for maintaining an electrical contact between said power means and said circuit means.

11. The transdermal drug applicator according to claim 10, wherein said detachable connector means includes said computer means forming a flat recess, a flat mounting element capable of being slidably received in said recess, said mounting element having a pair of opposed biasable ends and forming a pair of external notches, and a pair of opposed protrusions positioned in said recess, said biasable ends being capable of being pressed together by a user into a biased mode during insertion into said recess and of being released to an unbiased mode so that said notches engage said computer means at said protrusion.

12. The transdermal drug applicator according to claim 1, wherein said applicator means is mounted in direct association with said computer means.

13. The transdermal drug applicator according to claim 12, wherein said applicator means includes a filling tube positioned in association with said computer means, said tube having opposed ends, one end being in fluid connection with said at least one drug reservoir and the other end being port means capable of receiving a drug replacement, whereby said at least one reservoir can be refilled by way of said filling tube.

14. The transdermal drug applicator according to claim 13, wherein said at least one drug reservoir is removably connected to said computer means.

15. The transdermal drug applicator according to claim 14, further including computer activating means connected to said removable at least one drug reservoir for operating programmed resources within said computer means.

16. The transdermal drug applicator according to claim 15, wherein said at least one drug reservoir includes an electrically conductive cover means covering the outside surface of said at least one drug reservoir and an electrically conductive flange means in electrical connection with said cover means, said circuit means including said cover means and said flange means.

17. The transdermal drug applicator according to claim 1, further including standby power means connected to said computer means so as to prevent loss of data and memory from said computer means during down time when said applicator means is either being reloaded or not in use.

18. The transdermal drug applicator according to claim 1, including either an audible or mechanical alert device which may be employed as an advance warning in case of malfunction, loss of skin contact or weak power.

19. The transdermal drug applicator according to claim 1, 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.

20. The transdermal drug applicator according to claim 1, wherein said at least one drug reservoir is disposed in a disposable and replaceable cartridge, said cartridge being cooperatively associated with said programmable computer means.

21. The transdermal drug applicator according to claim 20, further including securing elements for attaching said cartridge to said mounting means.

22. The transdermal drug applicator according to claim 21, wherein said mounting means comprises straps for holding the transdermal drug applicator including said cartridge with said at least one drug reservoir to a body part.

23. The transdermal drug applicator according to claim 1, further including computer activating means associated with said at least one programmable computer means.

24. The transdermal drug applicator according to claim 23, wherein said applicator means is removably connected to said mounting means and wherein said computer activating means are associated with said at least one reservoir means in such a manner so as to select a program in said programmable computer means applicable to said at least one drug when said applicator means is connected to said mounting means.

25. The transdermal drug applicator according to claim 24, wherein said computer activating means comprises cams which activate said programmable computer means.

26. The transdermal drug applicator according to claim 25, wherein said cams mate with recesses in the mounting means to activate said programmable computer means according to a predetermined drug regimen.

27. The transdermal drug applicator according to claim 24, wherein said computer activating means comprises a bar code which activates said programmable computer means.

28. The transdermal drug applicator according to claim 27, wherein said bar code activates said programmable computer means according to a predetermined drug regimen.

29. The transdermal drug applicator according to claim 1, including another drug reservoir disposed in said skin-contacting surface of said applicator means and spaced from said at least one drug reservoir, wherein said another reservoir is in electrical communication with said circuit means.

30. The transdermal drug applicator according to claim 29, wherein said another reservoir is a return reservoir.

31. The transdermal drug applicator according to claim 30, wherein said return reservoir comprises a conductive adhesive layer.

32. The transdermal drug applicator according to claim 30, wherein said at least one drug reservoir and said return reservoir are concentrically disposed in said skin-contacting surface.

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

34. The transdermal drug applicator according to claim 33, wherein said means is a conductive adhesive.

35. The transdermal drug applicator according to claim 1, wherein said programmable computer means includes computer components and display means positioned in a case attachably associated with said mounting means, the computer components being in electrical connection with said applicator means.

36. The transdermal drug applicator according to claim 35, wherein said display means is an LCD.

37. The transdermal drug applicator according to claim 36, wherein said computer components are disposed in a housing that further includes elements for monitoring time, said time being displayed at said LCD.

38. The transdermal drug applicator according to claim 37, wherein said computer components further include the elements for transmitting data to said LCD relative to the rate of drug delivery, said LCD being capable of displaying said data as a function of current generated by said power means.

39. The transdermal drug applicator according to claim 38, further including an electrical connection between said computer components and said power means, said computer components being capable of controlling the power delivered by said power means.

40. The transdermal drug applicator according to claim 1, including sensing means associated with said mounting means for monitoring chemical and physical changes in said skin and transmitting signals relative to said changes to said programmable computer means, said programmable computer means being in electrical connection with said sensing means.

41. 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.

42. The transdermal drug applicator according to claim 41, wherein said independent sensing means includes a heart-monitoring device, said heart-monitoring device including a light tube means in contact with said skin and an LED positioned over said light tube means, and said LED being in electrical connection with said programmable computer means, wherein light reflected from said skin is measured by a photocell and the variations of the reflected light are used to compute a pulse rate.

43. The transdermal drug applicator according to claim 1, wherein said applicator means is removably connected to said programmable computer means.

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

45. The transdermal drug applicator according to claim 1, wherein said mounting means is a bracelet.

46. The transdermal drug applicator according to claim 1, wherein said applicator means is disposed between said mounting means and said skin.

47. The transdermal drug applicator according to claim 46, wherein said mounting means generally covers said applicator means upon being wrapped about a limb or other portion of the body.

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

49. The transdermal drug applicator according to claim 1, wherein at least said at least one drug reservoir is disposable or of the throwaway type.

50. The transdermal drug applicator according to claim 49, wherein said at least one drug reservoir is a cartridge-like housing which is disposable or of the throwaway type.

51. The transdermal drug applicator according to claim 1, wherein said applicator means includes a filling tube positioned in association with said computer means, said tube having opposed ends, one end being in fluid connection with said at least one drug reservoir and the other end being port means capable of receiving a drug replacement, whereby said at least one drug reservoir can be refilled by way of said filling tube.

52. The transdermal drug applicator according to claim 51, wherein said filling tube is capable of being refilled by a syringe.

53. The transdermal drug applicator according to claim 1, wherein said applicator means is disposable and replaceable.

54. The transdermal drug applicator according to claim 1, wherein said at least one drug reservoir is disposable and replaceable.

55. The transdermal drug applicator according to claim 1, further comprising computer power means associated with said programmable computer means for maintaining power to said programmable computer means.

56. The transdermal drug applicator of claim 1, wherein said at least one drug reservoir comprises a porous material in which said at least one drug is impregnated.

57. The transdermal drug applicator of claim 56, wherein said porous material is a pad.

58. The transdermal drug applicator of claim 56, wherein said porous material is a gel.

59. The transdermal drug applicator of claim 1, further including means for delivering said at least one drug on demand.

60. The transdermal drug applicator of claim 1, wherein said programmable computer means provides said controlled, automatic delivery of said at least one drug at a variable controlled rate at preset or preprogrammed time intervals.

61. A method for the controlled, automatic transdermal delivery of at least one drug through the skin or the like, comprising the steps of:

a) adhering the transdermal drug applicator according to claim 53 to the skin of a human being or animal; and

b) activating said computer activating means.

62. An electrically powered transdermal drug applicator that is adapted to be adhered to a mucous membrane of an animal or human being for the controlled, automatic delivery of at least one drug through the mucous membrane, comprising:

applicator means having a mucous membrane-contacting surface

and including at least one drug reservoir containing at least one drug;

flexible mounting means for removably adhering said applicator means to said mucous membrane;

power means electrically connected to said at least one drug reservoir at an electrode for delivery of said at least one drug;

circuit means completing an electrical circuit between said

at least one drug reservoir and said power means by return through the mucous membrane when said transdermal drug applicator is in use; and

programmable computer means associated with said mounting means for regulating the generation of power so as to provide the controlled, automatic delivery of said at least one drug through said mucous membrane.

63. The transdermal drug applicator according to claim 62, wherein said applicator means is disposed about a centrally disposed mounting means for contacting said mucous membrane.