Rigid sensor stopper for use in drug delivery devices

Abstract

The present disclosure relates to a stopper adapted for use in a drug delivery device. In one implementation, the stopper includes a rigid casing having a shape adapted to fit within a barrel of the drug delivery device; electronics disposed and sealed within the rigid casing; and an elastomeric seal disposed around at least a dispensing end of the rigid casing and a side of the rigid casing. The electronics include a power source and at least one of a transducer or a sensor coupled to the power source. The elastomeric seal comprises a single continuous material.

What is claimed is: 
     
         1 . A stopper, comprising:
 a rigid casing having a shape adapted to fit within a barrel of a drug delivery device;   electronics disposed and sealed within the rigid casing, wherein the electronics include a power source and at least one of a transducer or a sensor coupled to the power source; and   an elastomeric seal adapted to form a seal with the barrel when the stopper is inserted into the barrel of the drug delivery device, the elastomeric seal disposed around at least a dispensing end of the rigid casing and a side of the rigid casing and wherein the elastomeric seal comprises a single continuous material.   
     
     
         2 . The stopper of  claim 1 , further comprising:
 a cap disposed over an end of the rigid casing opposite the dispensing end, wherein the cap seals the electronics within the rigid casing.   
     
     
         3 . The stopper of  claim 2 , wherein the cap is secured to the rigid casing via an interference fit, one or more fasteners, a weld joint, or an adhesive. 
     
     
         4 . The stopper of  claim 1 , wherein the elastomeric seal extends around and fully encases the rigid casing. 
     
     
         5 . The stopper of  claim 4 , wherein the elastomeric seal comprises an overmold. 
     
     
         6 . The stopper of  claim 1 , wherein the elastomeric seal includes a ridge that encircles the side of the rigid casing and is adapted to seal against the barrel of the drug delivery device when the stopper is inserted into the drug delivery device. 
     
     
         7 . The stopper of  claim 6 , wherein the elastomeric seal includes a pair of ridges including the ridge that encircle the side of the rigid casing and are adapted to seal against the barrel of the drug delivery device when the stopper is inserted into the drug delivery device. 
     
     
         8 . The stopper of  claim 7 , wherein the pair of ridges are part of the single continuous material of the elastomeric seal. 
     
     
         9 . The stopper of  claim 1 , wherein the elastomeric seal comprises a coating of the single continuous material on outer surfaces of the rigid casing. 
     
     
         10 . The stopper of  claim 1 , further comprising:
 a phase-change material disposed within the rigid casing, the phase-change material having a chemical structure that changes phase at a temperature lower than a degradation temperature of the power source.   
     
     
         11 . The stopper of  claim 10 , wherein the degradation temperature is a temperature at which the power source is at least one of physically damaged, has a permanent reduction in specific energy, or has a permanent reduction in specific power. 
     
     
         12 . The stopper of  claim 10 , wherein the chemical structure of the phase-change material undergoes a solid-to-liquid transition or a solid-to-gas transition at the temperature lower than the degradation temperature of the power source. 
     
     
         13 . The stopper of  claim 10 , wherein the phase change material is disposed in physical contact with the power source. 
     
     
         14 . The stopper of  claim 10 , wherein the phase change material surrounds at least the power source. 
     
     
         15 . The stopper of  claim 10 , wherein the phase-change material includes at least one of a polymer or a hydrocarbon. 
     
     
         16 . The stopper of  claim 10 , wherein the phase change material includes a plurality of materials, and wherein each material in the plurality of materials has a different phase transition temperature. 
     
     
         17 . The stopper of  claim 1 , wherein the power source includes at least one of a battery including silver oxide, alkaline zinc, Li, CF x , or SOCl 2 . 
     
     
         18 . The stopper of  claim 1 , wherein the electronics further comprise at least one of: a microcontroller, an amplifier, an analog-to-digital converter, a radio transmitter, or an antenna. 
     
     
         19 . The stopper of  claim 1 , wherein the electronics further include a controller coupled to the transducer and the power source, wherein the controller includes logic that when executed by the controller causes the stopper to perform operations including:
 calculating a time of flight for ultrasonic signals to travel from the transducer, reflect off of a dispensing end of the barrel and return to the stopper.   
     
     
         20 . The stopper of  claim 1 , wherein the rigid casing comprises an overmold of the electronics and the electronics are embedded within rigid casing.