Electrotransport device with separable controller and drug unit and method of setting controller output

• US 5,978,701 A
• Filed: 06/02/1995
• Issued: 11/02/1999
• Est. Priority Date: 06/02/1995
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Lattin, Gary A., McNichols, Larry A., Johnson, Susan A.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/459,384
• Time in Patent Office: 1,614 Days
• Field of Search: 604/20-21, 607/115, 235/449, 235/454, 235/451
• US Class Current: 604/20
• CPC Class Codes: A61N 1/0412 Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• CPC Class Codes: A61N 1/0428 Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
• 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

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 (eg, reflected light), a signal sent by an electro-mechanical connector, an electrical signal (eg, resistance or capacitance), a magnetic signal or a metal detector sensing signal.

Claims

1. An electrotransport device comprising:

a therapeutic agent-containing unit having a reservoir containing the therapeutic agent to be delivered;

a controller for providing one of a plurality of electrotransport current outputs to the therapeutic agent-containing unit;

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 signaling mechanism which provides a signal to the controller, said controller comprising a predetermined set of outputs corresponding to a plurality of dosing regimens for said agent and further comprising a receiver for receiving the signal and setting an output in response to the signal, wherein the controller is adapted to deliver said agent at multiple rates, which rate is determined by selection of a therapeutic agent-containing unit.

2. The device of claim 1 wherein the signal comprises light reflected from a light reflective surface.

3. The device of claim 2, wherein the light reflective surface is on the therapeutic agent-containing unit.

4. The device of claim 3, wherein the controller includes an optical sensor which senses the reflected light.

5. The device of claim 4, wherein the optical sensor provides a sensor signal responsive to the intensity of the reflected light.

6. The device of claim 4, wherein the coupling means also aligns the optical sensor with the light reflective surface.

7. The device of claim 2, wherein the light reflective surface has one of a plurality of reflectivities.

8. The device of claim 2, wherein the controller has a light source and the therapeutic agent-containing unit has the light reflective surface, the light source and the light reflective surface being relatively positioned such that light from the light source illuminates the light reflective surface when the controller is coupled to the unit.

9. The device of claim 1, wherein the signal is related to a parameter selected from the group consisting of type of therapeutic agent in the unit, amount of therapeutic agent in the unit, concentration of therapeutic agent in the unit and combinations thereof.

10. The device of claim 1 wherein said plurality of dosing regimens comprises a low dosage rate and a high dosage rate for said agent.

11. The device of claim 1 wherein the agent comprises a narcotic analgesic.

12. A method of setting an electrical output of an electrotransport controller which is adapted to be coupled to one of a plurality of different therapeutic agent-containing units so that the output matches a predetermined output suitable for the particular unit, comprising:

selecting one of the plurality of different therapeutic agent-containing units;

coupling the selected unit to the controller;

providing a signal from the selected unit to the controller, said signal being related to a parameter selected from the group consisting of the amount of therapeutic agent in the unit, the concentration of the therapeutic agent in the unit, and combinations thereof;

receiving the signal by the controller; and

setting the output of the controller to the predetermined output in response to the received signal, whereby a single agent can be delivered at multiple rates by selection of an appropriate therapeutic agent-containing unit.

13. The method of claim 12, wherein the signal is an optical signal comprising light reflected from a light reflective surface.

14. The method of claim 13, wherein the light reflective surface has one of a plurality of reflectivities.

15. The method of claim 13, including shining a light from a light source on the reflective surface.

16. The method of claim 15, including sensing light reflected from the reflective surface using an optical sensor.

17. The method of claim 16, including providing a sensor signal responsive to the intensity of the reflected light.

18. The method of claim 16, including aligning the optical sensor and the reflective surface by coupling the controller and the selected unit.

19. The method of claim 12 wherein the agent comprises a narcotic analgesic.

20. An electrotransport device comprising:

a therapeutic agent-containing unit having a reservoir containing the therapeutic agent to be delivered;

a controller for providing one of a plurality of electrotransport current outputs to the therapeutic agent-containing unit;

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 first circuit portion, said first circuit portion including a resistance or capacitance portion of a predetermined magnitude;

the controller comprising a second circuit portion for coupling to said first circuit portion wherein said second circuit portion provides at least one logic input, said logic input determined by comparing said predetermined magnitude of the resistance or capacitance to at least one reference parameter, said reference parameter having a range of values associated therewith;

wherein the controller sets the controller output from among said plurality of electrotransport current outputs in accordance with said logic input.

21. The device of claim 20 wherein said at least one reference parameter comprises a reference voltage.

22. The device of claim 21 wherein the first circuit portion comprises a resistance portion and the logic input is determined by comparing the voltage drop across said resistance portion of said first circuit portion with said at least one reference voltage.

23. The device of claim 20 wherein the controller further comprises a third circuit portion for decoding said at least one logic input and providing an amplifier for controlling said electrotransport current output.

24. The device of claim 20 wherein the first circuit portion comprises a capacitance portion and said controller includes a capacitance sensor which senses a capacitance signal provided, at least in part, by the first circuit portion.

25. A kit for electrotransport agent delivery comprising:

a first set of therapeutic agent-containing units comprising a reservoir containing the therapeutic agent to be delivered at a first predetermined dosage rate;

a second set of therapeutic agent-containing units comprising a reservoir containing the therapeutic agent to be delivered at a second predetermined dosage rate;

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;

each of said therapeutic agent-containing units comprising a signaling mechanism which provides a signal to the controller, said controller comprising a predetermined set of outputs corresponding to said first and second dosage rates for said therapeutic agent and further comprising a receiver for receiving the signal and setting an output in response to the signal;

whereby said agent can be administered at multiple rates by appropriate selection of a therapeutic agent-containing unit.