Electrotransport device and method of setting output

• US 6,086,572 A
• Filed: 03/09/1998
• Issued: 07/11/2000
• Est. Priority Date: 05/31/1996
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Johnson, Susan A., Lattin, Gary A., McNichols, Larry A.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Sadula, Jennifer R.
• Application Number:
  US08/952,656
• Time in Patent Office: 855 Days
• Field of Search: 604/20, 604/14, 604/30, 604/501, 604/503
• US Class Current: 604/503
• CPC Class Codes: A61N 1/0432 Anode and cathode
• CPC Class Codes: A61N 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428

Abstract

A two-part electrotransport drug delivery device (20) is comprised of a controller (22) which has a plurality of different electronic outputs. The controller (22) is adapted to be mechanically and electrically coupled to a plurality of different drug-containing units (24). Each drug unit (24) includes a means (40, 42, Rx, Cx) for signaling the controller (22). The signal is read by the controller (22) and a predetermined electronic output is thereby selected and applied through the drug unit (24) in order to deliver the drug contained therein by electrotransport. The signal sent by the drug unit (24) to the controller (22) may be an optical signal (e.g., reflected light), a signal sent by an electro-mechanical connector, an electrical signal (e.g., resistance or capacitance), a magnetic signal or a metal detector sensing signal.

Claims

1. An electrotransport delivery device comprising a therapeutic agent-containing unit having a reservoir containing the therapeutic agent to be delivered, a controller for controlling electrotransport delivery of the agent, a coupler for separably coupling the controller and the therapeutic agent-containing unit, the coupler providing electrical connection between the controller and the therapeutic agent-containing unit,

the therapeutic agent-containing unit comprising a predetermined therapeutic agent delivery regimen signaling mechanism which provides a delivery regimen signal to the controller,

said controller capable of generating one of a plurality of predetermined outputs corresponding to a plurality of delivery regimens for said agent and further comprising a receiver for receiving the delivery regimen signal and setting one output selected from said plurality of outputs in response to the delivery regimen signal,

wherein the device is adapted to deliver said agent according to the selected delivery regimen which is determined by selection of a therapeutic agent-containing unit providing the corresponding delivery regimen signal.

2. The device of claim 1, wherein the delivery regimen signal includes an optical signal.

3. The device of claim 2, wherein the optical signal comprises light reflected from a light reflective surface (40, 42).

4. The device of claim 3, wherein the controller (22) includes a light source (46) and the therapeutic agent-containing unit (24) includes the light reflective surface (40, 42), the light source (46) and the light reflective surface (40, 42) being relatively positioned such that light from the light source (46) illuminates the light reflective surface (40, 42) when the controller (22) is coupled to the unit (24).

5. The device of claim 3, wherein the light reflective surface (40, 42) includes one of a plurality of reflectivities.

6. The device of claim 3, wherein the therapeutic agent-containing unit (24) includes the light reflective surface (40, 42).

7. The device of claim 4, wherein the controller (22) includes an optical sensor (48) adapted to sense the reflected light.

8. The device of claim 7, wherein the optical sensor (48) is adapted to provide a sensor signal responsive to the intensity of the reflected light.

9. The device of claim 7, wherein the coupler (26, 30 and 28, 32) is adapted to align the optical sensor (48) with the reflective surface (40, 42).

10. The device of claim 1, wherein the controller (22) includes a capacitance sensor (414) adapted to sense a capacitance signal (440, 441, 430) provided at least partially by the therapeutic agent-containing unit (401).

11. The device of claim 1, wherein the signal includes an electro-mechanical connector (360, 370, 362, 372, etc.) adapted to send a coded signal and adapted to mechanically and electrically couple the unit (358) to the controller (352).

12. The device of claim 1, wherein the signal comprises an electrical resistance signal (Rx), and wherein a portion of the contacts (370, 374) make electrical connection between the controller (314) and the unit (301).

13. The device of claim 1, wherein the signal is a magnetic field signal.

14. The device of claim 13, wherein the signal is produced by a magnet (516, 518) in the drug unit (508).

15. The device of claim 1, wherein the signal is produced by a metal in the drug unit, and wherein the signal is sensed by a metal detector in the controller.

16. The device of claim 1 wherein the signal is related to one or more parameters selected from the consisting of the type of agent in the unit, the amount of agent in the unit, the concentration agent in the unit, the maximum rate of agent delivery, the maximum overall time that the agent may be delivered, the maximum time per hour during which delivery can be made, and the maximum number of delivery periods that can be made.

17. The device of claim 1 wherein the delivery regimen signal comprises at least one set of a magnet and a magnetic sensor wherein one member of each set is attached to the agent-containing unit and the other member of the set is attached to the controller so that when the agent containing unit is coupled to the controller the magnetic sensor is positioned to detect the magnet.

26. The method of claim 16, wherein the signal is an electrical resistance signal (Rx).

27. The method of claim 16, wherein the signal is a coded signal generated from an electromechanical connector (360, 370, 362, 372, etc.) that mechanically and electrically couples the unit (358) to the controller (352).

28. The method of claim 16, wherein the signal is a magnetic field signal.

29. The method of claim 28, wherein the signal is produced by a magnet (516, 518) in the one unit.

30. The method of claim 16, wherein the signal is produced by a metal in the one unit, and wherein the signal is sensed by a metal detector in the controller.

31. The method of claim 16, wherein the signal is a capacitance signal (440, 441, 430).

18. A method of setting one electrical output selected from of a plurality of predetermined electrical outputs of a controller adapted to be coupled to one therapeutic agent-containing unit selected from a plurality of therapeutic agent-containing units each of which corresponds to one of a plurality of predetermined therapeutic agent delivery regimens wherein the selected electrical output will implement the corresponding therapeutic agent delivery regimen corresponding to the selected unit,

coupling the selected therapeutic agent-containing unit to the controller, the selected therapeutic agent-containing unit adapted to provide a delivery regimen signal to the controller wherein said delivery regimen signal indicates to said controller which one of the plurality of predetermined electrical outputs should be used with the selected therapeutic agent-containing unit;

and,

setting the output of the controller to one of the plurality of predetermined outputs which corresponds to the delivery regimen signal from the selected therapeutic agent-containing unit.

19. The method of claim 18, wherein the signal is an optical signal.

20. The method of claim 19, wherein the optical signal is light reflected from a light reflective surface (40, 42).

21. The method of claim 20, wherein the light reflective surface (40, 42) includes one of a plurality of reflectivities.

22. The method of claim 21, further including the step of shining a light source (46) on the reflective surface (40, 42).

23. The method of claim 22, further including the step of sensing light reflected from the reflective surface (40, 42) with an optical sensor (48).

24. The method of claim 23, further including the step of providing a sensor signal responsive to the intensity of the reflected light.

25. The method of claim 21, further including the step of aligning the optical sensor (48) with the reflective surface (40, 42) by coupling the controller (22) to the one unit (24).

32. The method of claim 24, further including the step of sensing the capacitance signal with a capacitance sensor (414).

33. The method of claim 18 wherein the signal is related to one or more parameters selected from the group consisting of the type of agent in the unit, the amount of agent in the unit, the concentration agent in the unit, the maximum rate of agent delivery, the maximum overall time that the agent may be delivered, the maximum time per hour during which delivery can be made, and the maximum number of delivery periods that can be made.

34. The method of claim 18 wherein the delivery regimen signal comprises at least one set of a magnet and a magnetic sensor wherein one member of each set is attached to the agent-containing unit and the other member of the set is attached to the controller so that when the agent containing unit is coupled to the controller the magnetic sensor is positioned to detect the magnet.

35. A kit for electrotransport delivery of an agent comprising:

a plurality of therapeutic agent-containing units, each unit comprising a reservoir containing the therapeutic agent to be delivered according to one delivery regimen selected from a plurality of predetermined delivery regimens;

a controller for controlling electrotransport delivery of the agent;

a coupler for separably coupling the controller and a therapeutic agent-containing unit selected from the plurality of therapeutic agent-containing units, the coupler providing electrical connection between the controller and the selected therapeutic agent-containing unit;

each of said therapeutic agent containing units comprising a therapeutic agent delivery regimen signaling mechanism which provides a delivery regimen signal to the controller, said controller comprising a predetermined set of outputs corresponding to said plurality of delivery regimens for said therapeutic agent and further comprising a receiver for receiving the signal and setting an output in response to the delivery regimen signal;

whereby each agent can be administered according to at least one of the predetermined delivery regimens by appropriate selection of a therapeutic agent containing unit having the corresponding delivery regimen signal.