Self-test for analgesic product

• US 9,645,179 B2
• Filed: 07/31/2015
• Issued: 05/09/2017
• Est. Priority Date: 05/21/2012
• Status: Expired due to Fees

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson), Incline Therapeutics, Inc. (Novartis Ag)
• Inventors: White, Bradley E., Lemke, John, Hayter, Paul, Chen, Corinna X., Read, Brian W., Dougherty, Jason E.
• Primary Examiner(s): Hall, Deanna K
• Application Number:
  US14/815,676
• Publication Number:
  US 20150338445A1
• Time in Patent Office: 648 Days
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/0416 Anode and cathode
• CPC Class Codes: A61N 1/0432 Anode and cathode
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/18 Applying electric currents by contact electrodes
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428
• 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
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: G01R 19/145 Indicating the presence of current or voltage
• CPC Class Codes: G01R 19/165 Indicating that current or voltage is either above or below a predetermined value or within or outside a predetermined range of values
• CPC Class Codes: G08B 21/182 Level alarms, e.g. alarms responsive to variables exceeding a threshold

Abstract

Electrotransport drug delivery devices, system and methods of using configured to determine if a current is present between the anode and cathode when drug is not intended to be delivered by the device. These devices/systems may include an off-current module to determine that any current (e.g., which may be inferred by measuring potential difference between the anode and cathode of the device) flowing between the anode and cathode is below a threshold value when the device is not supposed to be delivering drug, thereby preventing unintended delivery of drug and/or alerting a user that unintended delivery of drug may occur.

Claims

1. An electrotransport drug delivery device that prevents unwanted delivery of drug while in an off state when the device is powered on, the device comprising:

an anode and a cathode;

an activation circuit configured to apply current between the anode and cathode to deliver a drug by electrotransport when the device is in an on state and not in the off state; and

wherein the device is configured to shut down when there is a current flowing between the anode and cathode that is greater than an Output Current Off threshold when the device is in an off state while powered on;

further wherein the device is configured to automatically and periodically determine if there is a current flowing between the anode and cathode when the activation circuit is in the off state while powered on.

2. The device of claim 1, wherein the device is configured to determine if there is a potential difference between the anode and the cathode when the activation circuit is in the off state while powered on.

3. The device of claim 1, further configured to determine if there is a change in capacitance between the anode and cathode when the activation circuit is in the off state while powered on.

4. The device of claim 1, further configured to determine if there is a change in inductance between the anode and cathode when the activation circuit is in the off state while powered on.

5. The device of claim 1, further comprising a sensing circuit that independently determines an anode voltage and a cathode voltage and compares the potential difference between the anode voltage and cathode voltage to a threshold value.

6. The device of claim 5, further including a switch connected between a reference voltage source and a sense resistor, further comprising an off-current module configured to close the switch periodically to determine the potential difference between the anode voltage and cathode voltage.

7. The device of claim 1, further configured to determine if there is a current flowing between the anode and cathode when the activation circuit is in the off state at least once per minute.

8. The device of claim 1, further configured to determine if there is a current flowing between the anode and cathode when the activation circuit is in the off state between at least once every 10 ms and once every 10 minutes.

9. The device of claim 1, further configured to wait at least 10 ms before determining if there is a current flowing between the anode and cathode when the activation circuit is in the off state.

10. The device of claim 1, wherein the device has a two-part structure comprising:

an electrical module including the activation circuit and an off-current module; and

a reservoir module including the anode and the cathode and a source of drug to be delivered, wherein the drug comprises fentanyl;

wherein the electrical module and reservoir module are configured to be combined prior to application to a patient.

11. The device of claim 1, further configured to indicate that there is a current flowing between the anode and cathode when the activation circuit is in the off state while powered on where the current flowing is above the Output Current Off Threshold.

12. The device of claim 1, wherein the Output Current Off Threshold is about 9 μ

A.

13. The device of claim 1, further comprising an Rsense resistor and an Rsense accuracy module configured to verify the accuracy of an Rsense resistance value.

14. The device of claim 1, further comprising an anode/cathode voltage difference test that measures the anode voltage and the cathode voltage using the ADC and calculates the voltage difference between the two.

15. The device of claim 1, further comprising a reservoir module including the anode and the cathode and a source of the drug to be delivered, wherein the drug comprises fentanyl.

16. A method of automatically and periodically confirming that drug will not be delivered by an electrotransport drug delivery device when the device is in an off state while powered on, the method comprising:

determining if there is a current flowing between an anode and a cathode of the electrotransport drug delivery device when the electrotransport drug delivery device is in an off state while powered on, wherein the electrotransport drug delivery device includes an activation circuit that is configured to apply current between the anode and the cathode to deliver a drug when the device is in an on state and not deliver drug in the off state; and

triggering an indicator to indicate a leak current if there is a current flowing between the anode and cathode that is greater than an Output Current Off Threshold when the electrotransport drug delivery device is in an off state while powered on, wherein triggering an indicator comprises one or more of;

a visible notification, an audible notification, and a vibratory notification; and

performing a device shutdown when the indicator is triggered.

17. The method of claim 16, further comprising repeating the determining step periodically while the activation circuit is in an off state.

18. The method of claim 16, further comprising repeating the determining step at least once every 10 minutes while the activation circuit is in an off state and the device is powered on.

19. The method of claim 16, wherein the Output Current Off Threshold is about 9 μ

A.

20. The method of claim 16, wherein determining if there is a current flowing between the anode and cathode of the electrotransport drug delivery device comprises independently determining an anode voltage and a cathode voltage and comparing the potential difference between the anode voltage and cathode voltage to the threshold value.

21. The method of claim 16, wherein determining if there is a current flowing between the anode and cathode of the electrotransport drug delivery device comprises independently connecting a reference voltage source and a sense resistor with each of the anode and cathode to determine the potential difference between the anode voltage and cathode voltage.

22. The method of claim 16, wherein triggering the indicator comprises illuminating a light and/or sounding an alarm on the device.

23. The method of claim 16, wherein determining comprises determining if there is current flowing between the anode and the cathode of the electrotransport drug delivery device when the electrotransport drug delivery device is in the off state while powered on, wherein the electrotransport drug delivery device includes an activation circuit that is configured to apply current between the anode and the cathode to deliver fentanyl when the device is in the on state and not deliver drug in the off state.