Electrotransport drug delivery device

Abstract

A switch operated therapeutic agent delivery device is described. The device comprises two parts, which are assembled by a user prior to use. A first part contains a power supply and circuitry for the device; and a second part comprises electrodes and reservoirs containing the therapeutic agent to be delivered. The action of combining the two parts of the device causes the two parts to be irreversibly coupled together, completes an electrical connection between the two parts, and closes one or more switches, thereby connecting a power source, such as a battery, into the device's circuitry, thereby powering the device on so that it is ready for use. The device can then be attached to a patient, who can operate the device by pressing a button in a proper sequence.

What is claimed is: 
     
         1 . An electrotransport drug delivery system comprising an electrical module and a reservoir module that are combined to form a unitary, activated drug delivery system prior to use, wherein:
 the electrical module comprises:   control circuitry;   an electrical output connected to the control circuitry;   two or more power-on contacts between the control circuitry and a battery; and   the battery, which is isolated from the control circuitry by the two or more power-on contacts while at least one of the two or more power-on contacts remains open, and which is connected into the control circuitry when all of the two or more power-on contacts are closed by a battery contact actuator on the reservoir module when the electrical module and the reservoir module are combined; and   the reservoir module comprises:
 a pair of electrodes; 
 an electrical input that is separate from the electrical output until the electrical module and reservoir module are combined, wherein the electrical input connects the control circuitry to the pair of electrodes when the electrical module is combined with the reservoir module; and 
 two or more battery contact actuators each configured to close a corresponding power-on contacts of the two or more power-on contacts when the electrical module is combined with the reservoir module, such that the battery is connected into the control circuitry, powering the system. 
   
     
     
         2 . The system of  claim 1 , wherein the reservoir module includes a reservoir comprising fentanyl. 
     
     
         3 . The system of  claim 1 , further comprising a flexible polymeric cover over each of the two or more power-on contacts. 
     
     
         4 . The system of  claim 1  further comprising a flexible polymeric cover over each of the two or more power-on contacts, wherein the seal is configured to be deformed by the two or more battery contact actuators when the electrical module is combined with the reservoir module. 
     
     
         5 . The system of  claim 1 , further comprising a water-tight seal sealing the electrical output. 
     
     
         6 . The system of  claim 1 , wherein the electrical output is configured to flex while continuously applying a force on the electrical input of the reservoir module to ensure good electrical connection between the two. 
     
     
         7 . The system of  claim 1 , wherein the electrical input comprises a flat electrically conductive metal. 
     
     
         8 . The system of  claim 1 , wherein the electrical output comprises a protrusion or pin. 
     
     
         9 . The system of  claim 1 , further comprising a coupler on the reservoir module or the electrical module which couples with a corresponding coupler receptor on the electrical module or reservoir module, respectively, to prevent the unitary, activated drug delivery system from being separated. 
     
     
         10 . The system of  claim 9 , wherein the coupler comprises a snap mechanically biased to snap into a corresponding snap receptor. 
     
     
         11 . The system of  claim 1 , further comprising a pair of couplers on the reservoir module or the electrical module which couple with a pair of corresponding coupler receptors on the electrical module or reservoir module, respectively, to prevent the unitary, activated drug delivery system from being separated. 
     
     
         12 . The system of  claim 11 , wherein the couplers are of different sizes, whereby each coupler can be inserted only into its correspondingly sized coupler receptor, thereby ensuring that the system can be assembled in only one configuration. 
     
     
         13 . The system of  claim 11 , wherein the coupler is biased so that once the coupler is engaged with its corresponding receptor, the system cannot be disassembled without breaking the coupler. 
     
     
         14 . The system of one of  claim 1 , wherein the two or more battery contact actuators protrude from the reservoir module. 
     
     
         15 . The system of one of  claim 1 , wherein the two or more battery contact actuators protrude from the reservoir module and are each adapted to depress a receptacle on the electrical module when the electrical module is combined with the reservoir module, the receptacles being in mechanical communication with the two or more power-on contacts such that the battery is connected into the circuit when the battery contact actuators depresses the receptacle. 
     
     
         16 . The system of  claim 1 , wherein the control circuitry is configured to execute a power-on check when the battery is connected into the circuitry. 
     
     
         17 . The system of  claim 1 , wherein the control circuitry is configured to increment a logic flag when the electrical module is combined with the reservoir module, and wherein the control circuitry is configured such that, if the logic flag has met or exceeded a predetermined value, the system will either not power on or will power off if it has already powered on. 
     
     
         18 . The system of  claim 17 , wherein the control circuitry is configured to record an error code if the logic flag has met or exceeded a predetermined value. 
     
     
         19 . The system of  claim 1 , wherein the battery contact actuators are separated from each other by at least 0.5 cm. 
     
     
         20 . An electrotransport drug delivery system comprising an electrical module and a reservoir module that are combined to form a unitary, activated drug delivery system prior to use, wherein:
 the electrical module comprises:   control circuitry;   a power-on counter comprising a logic flag configured to increment when the control circuitry is powered on, wherein the circuitry powers the system off, or will not power the system on, if the number of counts in the power-on counter exceeds a predetermined value;   an electrical output connected to the control circuitry;   two or more power-on contacts between the control circuitry and a battery; and   the battery, which is isolated from the control circuitry by the two or more power-on contacts while at least one of the two or more power-on contacts remains open, and which is connected into the control circuitry when all of the two or more power-on contacts are closed by a battery contact actuator on the reservoir module when the electrical module and the reservoir module are combined; and   the reservoir module comprises:
 a pair of electrodes; 
 an electrical input that is separate from the electrical output until the electrical module and reservoir module are combined, wherein the electrical input connects the control circuitry to the pair of electrodes when the electrical module is combined with the reservoir module; and 
 two or more battery contact actuators each configured to close a corresponding power-on contacts of the two or more power-on contacts when the electrical module is combined with the reservoir module, such that the battery is connected into the control circuitry, powering the system.