Drug delivery device

• US 6,317,630 B1
• Filed: 01/29/1999
• Issued: 11/13/2001
• Est. Priority Date: 01/29/1999
• Status: Expired due to Fees

• Current Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Original Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Inventors: Gross, Yossi, Nitzan, Zvika
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/239,934
• Time in Patent Office: 1,019 Days
• Field of Search: 604/20, 604/19, 604/502, 128/898, 607/3, 607/50, 607/115, 607/152, 607/153, 607/154, 606/32
• US Class Current: 604/20
• 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 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

The present invention relates to a drug delivery device incorporating current and electromagnetic field sources to provide a controlled drug delivery system. The system can include a membrane with an RF antenna, a plurality of electrodes and contacts to provide an interface to a controller housing.

Claims

1. A drug delivery device comprising:

a membrane;

an antenna mounted to the membrane that emits an electromagnetic field onto a treatment site, the electromagnetic field having a frequency and intensity that alters a condition at the treatment site;

an electrode mounted to the membrane that provides a current through the membrane; and

a circuit that connects a control signal source to the antenna and the electrode, the signal source activating emission of the electromagnetic field and the electrode current.

2. The drug delivery device of claim 1 wherein the device further comprises an iontophorectic preparation.

3. The drug delivery device of claim 2 wherein the iontophoretic preparation comprises a preparation layer attached to the membrane.

4. The drug delivery device of claim 2 wherein the iontophoretic preparation comprises a reservior attached to the membrane.

5. The drug delivery device of claim 1 wherein the membrane comprises a flexible material.

6. The drug delivery device of claim 5 wherein the flexible material comprises paper.

7. The drug delivery device of claim 1 wherein the membrane comprises a material having a thickness in the range of 0.1 mm and 0.5 mm.

8. The drug delivery device of claim 1 wherein the membrane has a surface area in the range of 5 cm² to 200 cm².

9. The drug delivery device of claim 1 wherein the membrane further comprises a surface attachment device.

10. The drug delivery device of claim 9 wherein the surface attachment device comprises an adhesive layer on a bottom surface of the membrane.

11. The drug delivery device of claim 1 wherein the membrane further comprises a plurality of electronically conductive adhesive areas on the top surface for electrical and mechanical contact with the control signal source.

12. The drug delivery device of claim 1 wherein the antenna is printed onto the membrane.

13. The drug delivery device of claim 12 wherein the antenna is printed onto a top surface of the membrane.

14. The drug delivery device of claim 1 wherein the electromagnetic field comprises a radio frequency signal.

15. The drug delivery device of claim 13 wherein the radio frequency signal is in the range of 10 MHZ to 3 GHz.

16. The drug delivery device of claim 14 wherein the radio frequency signal is pulsed with a duty cycle.

17. The drug delivery device of claim 14 wherein the radio frequency (RF) signal has an RF power in the range of 10 mW and 1 W.

18. The drug delivery device of claim 10 wherein the antenna is less than 1 mm from the bottom surface.

19. The drug delivery device of claim 1 wherein the electrode comprises a plurality of electrodes printed onto the membrane.

20. The drug delivery device of claim 19 wherein the plurality of electrodes have been printed onto the membrane.

21. The drug delivery device of claim 1 wherein the current comprises a current in the range of 50 uA and 4 mA.

22. The drug delivery device of claim 1 wherein the current is pulsed by the control signal source in synchrony with electromagnetic pulses from the antenna.

23. The drug delivery device of claim 1 wherein the control signal source further comprises a battery.

24. The drug delivery device of claim 1 wherein the control signal source simultaneously transmits the electromagnetic field with the current.

25. The drug delivery device of claim 1 wherein the control signal source alternately actuates transmission of the electromagnetic field or the current.

26. The drug delivery device of claim 1 wherein the control signal source selectively transmits either the electromagnetic field or the current.

27. The drug delivery device of claim 1 wherein the control signal source further comprises a current switch.

28. The drug delivery device of claim 27 wherein the current switch stops the current when the drug delivery device is removed from a surface.

29. The drug delivery device of claim 1 wherein the control signal source further comprises a microprocessor.

30. The drug delivery device of claim 29 wherein the control signal source further comprises an input port for connection between the microprocessor and an external programming source.

31. The drug delivery device of claim 29 wherein the control signal source further comprises a wireless receiver for wireless connection between the microprocessor and an external programming source.

32. The drug delivery device of claim 29 wherein the control signal source further comprises plurality of switches to access programs in the microprocessor.

33. The drug delivery device of claim 1 further comprising a display that is connected to the control signal source.

34. A method of delivering a preparation to a patient comprising:

attaching a membrane to a skin surface of a patient in a region of interest, the membrane comprising an antenna for transmitting an electromagnetic field and an of electrode that transmits a current;

connecting the antenna and electrode to a control signal source;

activating the control signal source;

applying the electromagnetic field to the region of interest and applying the current to a preparation; and

delivering the preparation to the region of interest.

35. The method of claim 34 further comprising providing the preparation to an area of skin of the patient prior to attaching the membrane.

36. The method of claim 34 wherein the step of applying the electromagnetic field comprises generating a sequence of radio frequency (RF) pulses.

37. The method of claim 34 further comprising attaching the patch to the area of skin with an adhesive.

38. A method of delivering a preparation to a patient comprising:

attaching a membrane comprising an antenna for transmitting an electromagnitic field, an electrode that conducts a current, and a preparation on and area of skin of a patient;

connecting the antenna and electrodes to a control signal source;

activating the control signal source;

applying the electromagnetic field to the area and the current to the preparation; and

moving the preparation through the skin of the patient.

39. The method of claim 38 wherein the applying step comprises generating a radio frequency (RF) signal with the antenna and simultaneously delivering current across the plurality of electrodes.

40. The method of claim 38 further comprising alternating application of the electromagnetic field and the current.

41. The method of claim 38 further comprising providing a phase shift between radio frequency (RF) pulses and current pulses.

42. The method of claim 38 further comprising providing a working electrode and a counterelectrode.

43. The method of claim 38 further comprising varying a duty cycle of a radio frequency (RF) signal transmitted by the antenna.

44. The method of claim 38 further comprising attaching the membrane to the skin with an adhesive layer.

45. The method of claim 44 further comprising a second adhesive layer that attaches the membrane to a controller housing.

46. A method of enhancing the delivery of and agent across skin comprising the steps of:

attaching a membrane to a patient'"'"'s skin surface, the membrane having an antenna and an electrode in electrical communication with an agent to be delivered through the skin surface; and

concurrently applying an electromagnetic field at the skin surface and a an electrical current to the skin surface.

47. The method of claim 46 further comprising attaching a circuit housing to the membrane, the membrane having electrical contacts that electrically connect the antenna and the electrode to the circuit housing.

48. The method of claim 47 wherein the circuit housing has a control panel, a processor and a battery.