Electrotransport delivery device having improved safety and reduced abuse potential

• US 20060116662A1
• Filed: 01/18/2006
• Published: 06/01/2006
• Est. Priority Date: 09/26/1994
• Status: Active Grant

• Current Assignee: Gary A. Lattin, John D. Badzinski, Joseph B. Phipps, Larry A. Mcnichols, Ronald P. Haak, William N. Reining
• Original Assignee: Gary A. Lattin, John D. Badzinski, Joseph B. Phipps, Larry A. Mcnichols, Ronald P. Haak, William N. Reining
• Inventors: Phipps, Joseph B., Badzinski, John D., Lattin, Gary A., Reining, William N., Haak, Ronald P., McNichols, Larry A.
• Granted Patent: US 7,660,627 B2
• Time in Patent Office: Days
• US Class Current: 604/890.100
• 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 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/0448 Drug reservoir
• 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 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428

Abstract

An electrotransport device for delivering one or more therapeutic agents through the skin includes electrodes for contacting the skin, at least one electrode containing the agent, a power source for generating electrical current (I_L) for delivering the agent, a current generating and controlling means and a disabling means for permanently and irreversibly disabling the current. The disabling means may include a timer means, a counter means, or a body parameter sensor and limit comparator to effect permanent disabling. The disabling means may be a permanent transition to a disabled logic state, a permanent discharge of a power supply source, or a permanent diversion of electrotransport current from the electrodes, or a combination of the above. The permanent disabling means may include a circuit connection means having a frangible conducting member which permanently fractures and causes an irreversible open circuit in the connection to the electrodes upon removing a disposable/single use electrode assembly from a reusable portion of an electrotransport device.

Claims

1. An electrotransport device for delivering a therapeutic agent comprising:

a power source;

first and second electrodes and reservoirs, at least one of the reservoirs containing the therapeutic agent;

a current generating and controlling circuit configured to output no current flow when a current signal to the current controlling circuit is low and to generate current flow when the control signal to the current controlling circuit is high;

a current disabling circuit in communication with the current generating and controlling circuit, the current disabling circuit configured to output only a high signal or a low signal to respectively enable or disable the current generating and controlling circuit from supplying current to the electrodes, the current disabling circuit further including a circuit disabling element configured to provide an automatic, permanent and irreversible function to change the output from a high signal to a low signal and to permanently and irreversibly disable the current generating and controlling circuit from supplying current to the electrodes.

2. The electrotransport device of claim 1, further comprising a current sensing circuit in communication with the current generating and controlling circuit, the current sensing circuit configured to prevent inadvertent disabling of the current generating and controlling circuit.

3. The electrotransport device of claim 1, wherein the circuit disabling element comprises a counter configured to count the number of doses delivered by the electrotransport device.

4. The electrotransport device of claim 1, wherein the circuit disabling element comprises a long-range timer configured to disable the current generating and controlling circuit after at least a portion of the electrotransport device has exceeded a useful shelf life.

5. The electrotransport device of claim 1, wherein the circuit disabling element measures the cumulative amount of applied current and automatically and irreversibly disables the current generating and controlling circuit when the cumulative amount of applied current reaches a predetermined level.

6. The electrotransport device of claim 1, wherein the circuit disabling element includes a sensing circuit which senses when at least one of the electrodes is removed from body tissue and activates said circuit disabling element in response thereto.

7. The electrotransport device of claim 1, further comprising a sensor to sense a body parameter of a patient to which the device is applied, said sensor providing a disabling signal to said circuit disabling element when said sensed body parameter reaches some predetermined level.

9. The electrotransport device of claim 1, wherein the circuit disabling element measures the cumulative amount of applied current and automatically and irreversibly disables the current generating and controlling circuit when the cumulative amount of applied current reaches a predetermined level.

10. The electrotransport device of claim 1, further including a manually activated switch for activating the current generating and controlling circuit to generate said electric current for delivering the agent by electrotransport for a predetermined time;

a counter for counting the activations of said switch, the counter generating a disabling signal upon counting a predetermined number of activations of said switch;

the circuit disabling element being responsive to the disabling signal for automatically and irreversibly disabling the electrotransport current generating and controlling circuit upon receiving said disabling signal.

11. The electrotransport device of claim 1, wherein the agent comprises an abusable drug.

12. The electrotransport device of claim 10, wherein the abusable drug is a narcotic analgesic.

13. The electrotransport device of claim 10, wherein the abusable drug is selected from the group consisting of fentanyl, sufentanil, carfentanil, lofentanil, alfentanil, hydromorphone, oxycodone, propoxyphene, pentazocine, methadone, tilidine, butorphanol, buprenorphine, levorphanol, codeine, oxymorphone, meperidine, dihydrocodeinone and cocaine.

14. The electrotransport device of claim 1, including:

a first part adapted to be used and discarded after use, the first part containing the electrodes and a portion of the current generating and controlling circuit; and

a second reusable part adapted to be used with multiple first parts, the second part containing a portion of the current generating and controlling circuit;

a connector for mechanically and electrically connecting the first part to the second part, wherein disconnecting the first and second parts automatically and irreversibly disables the current generating and controlling circuit.

15. The device of claim 14, including a frangible electrical connection which is broken by disconnecting the first and second parts.

17. The electrotransport device of claim 1, further comprising current sensing means in communication with the first circuit means, the current sensing means configured to prevent inadvertent disabling of the current generating and controlling circuit.

8. The electrotransport device of claim 8, wherein the sensed body parameter is selected from the group consisting of body temperature, heart rate, breathing rate, blood or tissue oxygen content, blood or tissue carbon dioxide content, blood pressure, blood glucose content, composition of sweat, and body motion.

16. An electrotransport device for delivering a therapeutic agent comprising:

a power source;

first and second electrodes and reservoirs, at least one of the reservoirs containing the therapeutic agent;

a first circuit means to output no current flow when a current signal to the first circuit means is low and to generate current flow when the control signal to the first circuit means is high;

current disabling means in communication with the first circuit means, the current disabling means configured to output only a high signal or a low signal to respectively enable or disable the first circuit means from supplying current to the electrodes, the current disabling means further including circuit disabling means configured to provide an automatic, permanent and irreversible function to change the output from a high signal to a low signal and to permanently and irreversibly disable the first circuit means from supplying current to the electrodes.

18. A method of delivering an agent by electrotransport comprising:

applying an electrotransport device including a pair of electrodes, at least one of the electrodes containing the agent to be delivered, a source of electrical power adapted to be electrically connected to the pair of electrodes, a current generating and controlling circuit connected to a source of electrical power for generating an electric current output for delivering the agent by electrotransport, and a current disabling circuit in communication with the current generating and controlling circuit adapted to send only high and low signals; and

automatically and irreversibly changing the signal from the current disabling circuit from a high signal to a low signal after a predetermined event.

19. The method of claim 18, wherein the event is selected from the group consisting of:

elapse of a predetermined period of time;

application of a predetermined cumulative amount of current by the device;

removal of at least one of the electrodes from a body surface of a patient;

sensing a predetermined level of a patient body parameter by a sensor;

counting a predetermined number of activations of a manually activated switch for temporarily setting the current output at a predetermined level; and

breaking a frangible electrical connection within the device.