Drug delivery device and method of operation

Abstract

A computerized electro-mechanical drug delivery device configured to deliver at least one dose of two or more medicaments. The device comprises a control unit. An electro-mechanical drive unit is operably coupled to the control unit and a primary reservoir for a first medicament and a secondary reservoir for a fluid agent, e.g. a second medicament. An operator interface is in communication with the control unit. A single dispense assembly is configured for fluid communication with the primary and the secondary reservoir. Activation of the operator panel sets a first dose from the primary reservoir and based on the first dose and a therapeutic dose profile, the control unit is configured to determine a dose or range of the fluid agent. Alternatively, the control unit determines or calculates a dose or range of a third medicament. Further, a dispense interface for use with a drug delivery device is disclosed.

What is claimed is: 
     
         1 . A drug delivery device comprising:
 a cartridge retainer configured to receive a cartridge of medicament, the cartridge retainer moveable between an open position and a closed position;   one or more switches configured to detect or to confirm whether the cartridge retainer has been closed;   a display comprising one or more display icons, the one or more display icons providing a visual indication of a dose dispense status; and   a housing comprising a first window enabling medicament contained within the cartridge of medicament to be viewed through the first window when the cartridge of medicament is retained within the drug delivery device.   
     
     
         2 . A drug delivery device according to  claim 1 , wherein the drug delivery device is configured to communicate via a data link with at least one external computing device. 
     
     
         3 . A drug delivery device according to  claim 2 , wherein the at least one external computing device is a mobile phone. 
     
     
         4 . A drug delivery device according to  claim 2 , wherein the drug delivery device is configured to communicate dose history information via the data link. 
     
     
         5 . A drug delivery device according to  claim 2 , wherein the data link is a wireless data link. 
     
     
         6 . A drug delivery device according to  claim 5 , wherein the data link is provided by an interface employing the Bluetooth SIG short-range wireless technology standard. 
     
     
         7 . A drug delivery device according to  claim 1 , wherein the housing further comprises a second window located on an opposite side of the drug delivery device from the first window. 
     
     
         8 . A drug delivery device according to  claim 1 , the one or more display icons providing a visual indication of a device error. 
     
     
         9 . A drug delivery device according to  claim 1 , the one or more display icons providing a visual indication that an incorrect cartridge has been loaded into the cartridge retainer. 
     
     
         10 . A drug delivery device according to  claim 1 , the one or more display icons providing a visual indication of a battery level. 
     
     
         11 . A drug delivery device according to  claim 1 , the one or more display icons providing a visual warning that the remaining battery charge has reached a predetermined threshold level. 
     
     
         12 . A drug delivery device according to  claim 1 , wherein the drug delivery device is configured to determine whether there is sufficient power available in a battery of the drug delivery device to deliver a next dose. 
     
     
         13 . A drug delivery device according to  claim 12 , wherein when the drug delivery device determines that there is not sufficient power available in the battery of the drug delivery device, the drug delivery device is configured to automatically prevent the next dose from being dispensed. 
     
     
         14 . A drug delivery device according to  claim 13 , wherein the drug delivery device further comprises a monitoring circuit configured to check a voltage of the battery under different load conditions in order to predict a likelihood of the next dose being completed. 
     
     
         15 . A drug delivery device according to  claim 1 , wherein the drug delivery device is configured to go into a sleep mode after a predetermined period of inactivity. 
     
     
         16 . A drug delivery device according to  claim 1 , wherein the drug delivery device comprises a sounder configured to generate a tone when the drug delivery device experiences an operation error. 
     
     
         17 . A drug delivery device according to  claim 1 , wherein the drug delivery device comprises a sounder configured to generate a tone when a cartridge that is not properly coded has been inserted into the cartridge retainer. 
     
     
         18 . A drug delivery device according to  claim 1 , wherein the drug delivery device comprises a sounder configured to generate a tone indicating a completion of a dose delivery. 
     
     
         19 . A drug delivery device according to  claim 1 , wherein the one or more switches are configured to detect or to confirm whether the cartridge retainer has been properly closed. 
     
     
         20 . A drug delivery device according to  claim 1 , wherein the one or more switches are configured to detect whether the cartridge retainer has been closed and configured to confirm whether the cartridge retainer has been closed. 
     
     
         21 . A drug delivery device according to  claim 1 , the drug delivery device further comprising:
 a motor configured to advance a stopper in the cartridge of medicament;   a controller; and   a motion detection system configured to provide positional feedback to the controller based on rotation of the motor.   
     
     
         22 . A drug delivery device according to  claim 21 , wherein the cartridge retainer comprises a hinged door rotatable about a pivot point between the open position and the closed position, the hinged door including an internal cavity configured to receive the cartridge of medicament. 
     
     
         23 . A drug delivery device according to  claim 22 , wherein the motor is configured to advance the stopper in the cartridge of medicament via a piston rod mechanically linked to the motor, the piston rod being moveable between a first fully withdrawn position and a second fully extended position, and wherein the hinged door can only be opened when the piston rod is in the first fully withdrawn position. 
     
     
         24 . A drug delivery device according to  claim 1 , the drug delivery device comprising an electronic cartridge detection system configured to determine if the cartridge of medicament has been inserted into the cartridge retainer, wherein the electronic cartridge detection system is provided along an internal surface wall of the drug delivery device and is operable to determine if the cartridge of medicament has been inserted into the cartridge retainer when the cartridge retainer is in the closed position. 
     
     
         25 . A system comprising:
 a cartridge of medicament; and   a drug delivery device comprising:
 a cartridge retainer configured to receive the cartridge of medicament, the cartridge retainer moveable between an open position and a closed position; 
 one or more sensors configured to detect or to confirm whether the cartridge retainer has been closed; 
 a display comprising one or more display icons, the one or more display icons providing a visual indication of a dose dispense status; and 
 a housing comprising a first window enabling medicament contained within the cartridge of medicament to be viewed through the first window when the cartridge of medicament is retained within the drug delivery device. 
   
     
     
         26 . A drug delivery device comprising:
 a hinged cartridge retainer configured to receive a cartridge of medicament in an internal cavity of the hinged cartridge retainer, the hinged cartridge retainer rotatable between an open position and a closed position;   a display comprising one or more display icons, the one or more display icons providing a visual indication of a device operation including one or more of a dose dispense status, a device error, a battery level and a battery threshold level, the display configured to display a confirmation of the contents of the medicament cartridge; and   a housing comprising a first window enabling medicament contained within the cartridge of medicament to be viewed through the first window when the cartridge of medicament is retained within the drug delivery device.   
     
     
         27 . A drug delivery device comprising:
 a cartridge retainer configured to receive a cartridge of medicament, the cartridge retainer moveable between an open position and a closed position;   one or more switches configured to detect or to confirm whether the cartridge retainer has been closed;   a display comprising one or more display icons, the one or more display icons providing a visual indication of device status; and   a wireless data link provided by an interface employing the Bluetooth SIG short-range wireless technology standard, wherein the drug delivery device is configured to communicate dose history information with a mobile phone via the wireless data link.   
     
     
         28 . A drug delivery device according to  claim 27  further comprising a housing comprising a first window enabling medicament contained within the cartridge of medicament to be viewed through the first window when the cartridge of medicament is retained within the drug delivery device. 
     
     
         29 . A drug delivery device according to  claim 27 , the one or more display icons also providing a visual indication that an incorrect cartridge has been loaded into the cartridge retainer. 
     
     
         30 . A drug delivery device according to  claim 27  further comprising:
 a motor configured to advance a stopper in the cartridge of medicament; 
 a controller; and 
 a motion detection system configured to provide positional feedback to the controller based on rotation of the motor.