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 .- 30 . (canceled) 
     
     
         31 . A method of dispensing a substance from a drug delivery device having a plunger rod and a barrel, the method comprising:
 advancing the plunger rod by a predetermined distance into the barrel until advancement of the plunger rod is resisted by a stop;   deactivating the stop; and   actuating the plunger rod to deliver the substance.   
     
     
         32 . The method of  claim 31 , wherein advancing the plunger rod comprises rotating a pinion against a rack disposed on the plunger rod. 
     
     
         33 . The method of  claim 32 , wherein the stop comprises a shaft removably affixed to the pinion, and wherein deactivating the stop comprises removing the shaft from the pinion. 
     
     
         34 . The method of  claim 31 , wherein deactivating the stop comprises rotating the plunger rod. 
     
     
         35 . The method of  claim 31 , wherein the plunger rod comprises a flange, and wherein the stop comprises a lock that prevents the flange from entering the barrel. 
     
     
         36 . The method of  claim 35 , wherein deactivating the stop comprises removing the lock. 
     
     
         37 . The method of  claim 35 , wherein deactivating the stop comprises breaking the lock. 
     
     
         38 .- 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 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 a plunger, wherein the plunger and the plunger rod are together formed in a one-piece construction;   a stop movable between a first configuration and a second configuration, wherein the stop is configured to prevent distal movement of the plunger rod after the plunger rod moves a priming distance while the stop is in the first configuration, and is configured to allow the plunger rod to move further distally through the barrel after being transitioned from the first configuration to the second configuration; and   a flange contacting the proximal end of the barrel, the flange including a body and a hole that receives the plunger rod.   
     
     
         42 . The drug delivery device of  claim 41 , wherein the stop (i) includes one projection on the plunger rod, (ii) includes two projections on the plunger rod, (iii) includes a lock or pin, (iv) includes threads or teeth, or (v) is disposed within an interior of the barrel. 
     
     
         43 . The drug delivery device of  claim 42 , wherein the lock is configured to be removed or broken to allow actuation of the plunger rod relative to the barrel. 
     
     
         44 . The drug delivery device of  claim 41 , wherein the plunger rod is rotatable about the central longitudinal axis relative to the flange. 
     
     
         45 . The drug delivery device of  claim 41 , wherein the drug delivery device is a pre-filled syringe. 
     
     
         46 . A method of preparing the drug delivery device of  claim 41  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. 
 
     
     
         47 . The drug delivery device of  claim 41 , wherein the stop includes two projections on the plunger rod that are symmetrically disposed about the central longitudinal axis, and protrude in directions perpendicular to the central longitudinal axis. 
     
     
         48 . The drug delivery device of  claim 47 , wherein the hole has a geometry configured to receive the projections when the drug delivery device is in a dosage delivery configuration, wherein the body has a one-piece construction, and the hole has a circumference that is fully enclosed by the body. 
     
     
         49 . 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;   a plunger affixed to the plunger rod, wherein the plunger and the plunger rod are defined together in a one-piece construction where the plunger and the plunger rod are formed in a single mold; and   a stop movable between a first configuration and a second configuration, wherein in the first configuration, the stop is configured to prevent distal movement of the plunger rod after the plunger rod moves a priming distance, and after being transitioned from the first configuration to the second configuration, the stop is configured to allow the plunger rod to move further distally through the barrel.   
     
     
         50 . The drug delivery device of  claim 49 , wherein the stop is transitioned from the first configuration to the second configuration by removing or breaking a lock to allow actuation of the plunger rod relative to the barrel. 
     
     
         51 . The drug delivery device of  claim 49 , wherein the stop is transitioned from the first configuration to the second configuration by rotating the plunger rod about the central longitudinal axis of the drug delivery device. 
     
     
         52 . The drug delivery device of  claim 49 , wherein the stop is transitioned from the first configuration to the second configuration by rotating a sleeve coupled to the plunger rod about the central longitudinal axis of the drug delivery device. 
     
     
         53 . The drug delivery device of  claim 49 , wherein the stop is transitioned from the first configuration to the second configuration by translating the plunger rod relative to the barrel along the central longitudinal axis of the drug delivery device.