Cartridge with distributed electronic components

Abstract

A stopper is disclosed herein. The stopper is configured to be disposed within a medical cartridge. The stopper includes a shell defining a cavity, a core arranged within the cavity, and at least one electronic device embedded within the core, wherein the at least one electronic device includes a sensor and wherein the shell is configured to pass a sensing signal therethrough.

1 . A method of manufacturing a medicament container, the method comprising:
 embedding at least one electronic device into a core of a stopper;   coupling the core of the stopper with a shell of the stopper, the shell providing heat resistance to the at least one electronic device embedded in the core;   sterilizing the stopper while the at least one electronic device is embedded in the core of the stopper and the core is coupled to the shell of the stopper; and   inserting the sterilized stopper into the medicament container.   
     
     
         2 . The method of  claim 1 , wherein sterilizing the stopper comprises sterilizing the stopper at a temperature of at least 120 degrees Celsius for a duration of at least 20 minutes. 
     
     
         3 . The method of  claim 2 , wherein the duration is between 20 minutes and 30 minutes. 
     
     
         4 . The method of  claim 2 , wherein sterilizing the stopper comprises sterilizing the entire stopper at the temperature of at least 120 degrees Celsius for the duration of at least 20 minutes. 
     
     
         5 . The method of  claim 4 , further comprising determining, by a processor of the at least one electronic device, a position of the stopper within the medicament container after the entire stopper has been heat sterilized at the temperature of at least 120 degrees Celsius for the duration of at least 20 minutes. 
     
     
         6 . The method of  claim 1 , further comprising disposing the medicament container within a housing of an injection device with the stopper inserted into the medicament container. 
     
     
         7 . The method of  claim 6 , wherein the injection device is an auto-injector. 
     
     
         8 . The method of  claim 6 , further comprising rotating a dosage knob of the injection device to select a quantity of a medicament dose to be administered by the injection device. 
     
     
         9 . The method of  claim 8 , further comprising depressing an injection button of the injection device to eject the selected quantity of the medicament dose from the medicament container. 
     
     
         10 . The method of  claim 6 , further comprising receiving, by a sensor of the at least one electronic device, a reflected portion of a sensing signal through the shell when the medicament container is disposed within the housing of the injection device. 
     
     
         11 . The method of  claim 10 , further comprising determining, by a processor of the at least one electronic device, a position of the stopper within the medicament container based on the received portion of the reflected sensing signal. 
     
     
         12 . The method of  claim 11 , wherein determining the position of the stopper is performed after a quantity of medicament has been dispensed from the medicament container. 
     
     
         13 . The method of  claim 1 , further comprising impacting the stopper while the stopper is inserted into the medicament container to switch the at least one electronic device from a powered-off state to a powered-on state. 
     
     
         14 . The method of  claim 13 , further comprising providing a force on the stopper by a drive mechanism of an injection device to switch the at least one electronic device from the powered-off state to the powered-on state when the medicament container is disposed within a housing of the injection device. 
     
     
         15 . The method of  claim 1 , wherein the shell comprises a first portion and a second portion, the first portion and the second portion comprising different materials. 
     
     
         16 . A method comprising:
 sterilizing a stopper while at least one electronic device is embedded in the stopper;   inserting the sterilized stopper into a medicament container;   positioning the medicament container containing the sterilized stopper within a housing of an injection device such that
 (i) a plunger rod of the injection device is configured to engage the sterilized stopper to dispense a quantity of a medicament from the medicament container when the quantity of the medicament has been set using a dosage knob of the injection device and an injection button of the injection device is depressed; and 
 (ii) a processor of the at least one electronic device is configured to determine a position of the stopper within the medicament container based on a reflected portion of a signal that has passed through the stopper after the quantity of the medicament has been dispensed from the medicament container. 
   
     
     
         17 . The method of  claim 16 , wherein sterilizing the stopper comprises sterilizing the stopper at a temperature of at least 120 degrees Celsius for a duration of at least 20 minutes. 
     
     
         18 . The method of  claim 17 , wherein the duration is between 20 minutes and 30 minutes. 
     
     
         19 . The method of  claim 16 , wherein the injection device is an auto-injector, and the method further comprises transmitting, by a wireless transceiver of the at least one electronic device, the determined position of the stopper to a device external to the auto-injector. 
     
     
         20 . The method of  claim 16 , wherein the stopper comprises two different materials.