Electrotransport Delivery Device Having Improved Safety and Reduced Abuse Potential

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.

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.   a manually activated switch for activating the current generating and controlling circuit to generate said electric current for delivering the agent by electrotransport;   a sensor to sense a body parameter of a patient to which the device is applied, the sensor providing a disabling signal when the sensed body parameter reaches some predetermined level;   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.   
   
   
       2 . The electrotransport device of  claim 1 , further comprising a sense circuit which compares the sensed body parameter to a predetermined limit. 
   
   
       3 . The electrotransport device of  claim 1 , 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. 
   
   
       4 . 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. 
   
   
       5 . The electrotransport device of  claim 4 , wherein the circuit disabling element comprises a timer configured to disable the current generating and controlling circuit if the current sensing circuit outputs a low level for a period of time exceeding a predetermined value. 
   
   
       6 . 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. 
   
   
       7 . The electrotransport device of  claim 1 , wherein the agent comprises an abusable drug. 
   
   
       8 . The electrotransport device of  claim 7 , wherein the abusable drug is a narcotic analgesic. 
   
   
       9 . The electrotransport device of  claim 8 , 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. 
   
   
       10 . The electrotransport device of  claim 1 , wherein the body parameter sensor is a component of the delivery device. 
   
   
       11 . The electrotransport device of  claim 1 , wherein the body parameter sensor is a separate self-contained unit remote of the delivery device. 
   
   
       12 . A method of operating an electrotransport device, comprising:
 applying to a patient the electrotransport device of  claim 1 , and   automatically and irreversibly changing the signal from the current disabling circuit from a high signal to a low signal after the body parameter of the patient is sensed.   
   
   
       13 . The method of  claim 11 , 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.