Devices and methods for precision dose delivery

Abstract

Disclosed herein are delivery devices for delivering a volume of a drug product, placebo product, or other product including a fluid. The devices may include a barrel having a longitudinal axis, a proximal end region, and a distal end region. The proximal end region may include an opening, and the barrel may be configured to receive a drug therein. A plunger rod may be disposed at least partially inside the barrel and protruding from the opening. The plunger rod may include a rack having a plurality of teeth. The device may further include a pinion having a plurality of teeth configured to engage with the plurality of teeth of the rack, and rotation of the pinion against the rack may move at least a part of the plunger rod along the longitudinal axis of the barrel.

1 - 40 . (canceled) 
     
     
         41 . A drug delivery device having a dose expulsion control mechanism, the drug delivery device comprising:
 a barrel including a proximal end and a distal end;   a plunger rod extending into the barrel through an opening at the proximal end of the barrel, the plunger rod including a depressor and two projections, the projections protruding radially outward from a central longitudinal axis of the drug delivery device; and   a flange capping the proximal end of the barrel, the flange including an opening;   wherein rotating the plunger rod about the central longitudinal axis transitions the drug delivery device from an initial configuration to a dosage delivery configuration, and   wherein, in the initial configuration, the flange blocks distal movement of the projections to limit distal movement of the plunger rod to a priming distance, and in the dosage delivery configuration, the flange allows distal movement of the projections to allow the plunger rod to move a dosage delivery distance.   
     
     
         42 . The drug delivery device of  claim 41 , wherein, when the drug delivery device is in the initial configuration, the projections are spaced from a proximal side of the flange by a priming distance, and wherein transitioning the configuration of the drug delivery device from the initial configuration to a primed configuration includes advancing the plunger rod distally until the projections contact the proximal side of the flange. 
     
     
         43 . The drug delivery device of  claim 41 , wherein transitioning the configuration of the drug delivery device from the initial configuration to the dosage delivery configuration includes rotating the plunger rod 90 degrees about the central longitudinal axis. 
     
     
         44 . The drug delivery device of  claim 41 , wherein the plunger rod includes more than two projections. 
     
     
         45 . The drug delivery device of  claim 41 , wherein the flange is a finger flange. 
     
     
         46 . The drug delivery device of  claim 41 , wherein the projections are of similar shape and size. 
     
     
         47 . The drug delivery device of  claim 41 , further comprising a plunger inside the barrel and in contact with the plunger rod;
 wherein movement of the plunger rod by the dosage delivery distance does not cause the plunger to contact the distal end of the barrel.   
     
     
         48 . A drug delivery device having a dose expulsion control mechanism, the drug delivery device comprising:
 a barrel including a proximal end and a distal end;   a plunger rod extending into an interior of the barrel through an opening at the proximal end of the barrel and along a central longitudinal axis of the drug delivery device, the plunger rod including a depressor and two projections, wherein the projections are symmetrically disposed about the central longitudinal axis and protrude in directions perpendicular to the central longitudinal axis; and   a flange contacting the proximal end of the barrel, the flange including a geometry configured to receive the projections when the drug delivery device is in a dosage delivery configuration.   
     
     
         49 . The drug delivery device of  claim 48 , wherein the flange covers the proximal end of the barrel. 
     
     
         50 . The drug delivery device of  claim 48 , wherein the flange is a finger flange. 
     
     
         51 . The drug delivery device of  claim 48 , wherein the geometry of the flange includes a hole. 
     
     
         52 . The drug delivery device of  claim 48 , wherein the plunger rod is rotatable about the central longitudinal axis relative to the flange. 
     
     
         53 . The drug delivery device of  claim 48 , wherein the drug delivery device is a pre-filled syringe. 
     
     
         54 . A method of preparing the drug delivery device of  claim 48  for delivering a dose of a drug substance, the method comprising:
 advancing the plunger rod distally into the barrel; and 
 rotating the plunger rod about the central longitudinal axis by 90 degrees, relative to the flange. 
 
     
     
         55 . The drug delivery device of  claim 48 , wherein the projections are symmetrical in size and shape. 
     
     
         56 . The drug delivery device of  claim 48 , wherein the geometry of the flange is symmetrical about the central longitudinal axis of the drug delivery device. 
     
     
         57 . A drug delivery device having a dose expulsion control mechanism, the drug delivery device comprising:
 a barrel including a proximal end and a distal end;   a plunger rod extending into an interior of the barrel along a central longitudinal axis of the drug delivery device, wherein the plunger rod includes two projections disposed symmetrically about the central longitudinal axis, and wherein the plunger rod is rotatable about the central longitudinal axis; and   a flange including a geometry configured to receive the projections when the projections are in alignment with the geometry;   wherein, in an initial configuration of the drug delivery device, the projections are longitudinally spaced from the flange and are not in alignment with the geometry, in a primed configuration of the drug delivery device, the projections contact a proximal side of the flange and are not in alignment with the geometry, in a dosage delivery configuration of the drug delivery device, the projections are in alignment with the geometry and are disposed proximally from the geometry, and in a delivered configuration of the drug delivery device, the projections are in alignment with, and are received within, the geometry.   
     
     
         58 . The drug delivery device of  claim 57 , further comprising:
 a plunger disposed inside the barrel and in contact with the plunger rod;   wherein, when the drug delivery device is in the delivered configuration, the plunger is not flush with the distal end of the barrel.   
     
     
         59 . The drug delivery device of  claim 57 , further comprising:
 a plunger disposed inside the barrel and in contact with the plunger rod;   a first volume of drug product disposed in between the plunger and the distal end of the barrel when the drug delivery device is in the initial configuration;   a second volume of drug product disposed in between the plunger and the distal end of the barrel when the drug delivery device is in each of the primed and dosage delivery configurations, wherein the second volume of drug product is smaller than the first volume of drug product; and   a third volume of drug product disposed in between the plunger and the distal end of the barrel when the drug delivery device is in the delivered configuration, wherein the third volume of drug product is smaller than the second volume of drug product and greater than zero.   
     
     
         60 . The drug delivery device of  claim 58 , wherein
 transitioning a configuration of the drug delivery device from the initial configuration to the primed configuration includes pressing a depressor on the plunger rod to advance the plunger rod distally relative to the barrel until advancement of the plunger rod is blocked by the flange,   transitioning a configuration of the drug delivery device from the primed configuration to the dosage delivery configuration includes rotating the plunger rod relative to the flange, and   transitioning a configuration of the drug delivery device from the dosage delivery configuration to the delivered configuration includes pressing the depressor on the plunger rod to advance the plunger rod distally relative to the barrel until advancement of the plunger rod is blocked by the flange again.