Patent ID: 8361025
Filing Date: 2013-01-29
Classification: A61K,A61M

Abstract:
1. A single-use device for self-delivery of follicle stimulating hormone solution, the device comprising: an elongated main housing with distal and proximal portions arranged along a longitudinal axis; an elongated rotator being connected to the proximal portion of the main housing and rotatable about the longitudinal axis with respect to the main housing; a knob extending from the proximal portion of the housing and being rotatable with respect to the main housing between a lock position and seven or fewer discrete dosing positions for setting variable dose delivery of follicle stimulating hormone (FSH) solution, the knob having longitudinally spaced elements respectively corresponding to the lock position and the seven or fewer discrete dosing positions; a plunger rod rotatably engaged to a portion of the rotator and longitudinally spring biased, the plunger rod being rotatably locked to the knob in the locked position on the element corresponding to the lock position, the plunger rod being incrementally movable along the longitudinal axis between the element corresponding to the lock position and one of the elements of the seven or fewer discrete dosing positions; a permanently encased needle assembly having a permanently attached needle, the needle having an internal end and a working end; a cartridge holder proximately attached to the needle assembly, the cartridge holder holding an elongated drug cartridge containing the FSH solution, the FSH solution being sterile and preservative free to allow only a single use of the device, the drug cartridge being permanently encased within the cartridge retainer and having a penetrable membrane adjacent the internal end of the needle and a movable plunger adjacent to the plunger rod, the drug cartridge being fluidly disconnected from the internal end of the needle when the knob is in the locked position; a needle shield movable with respect to the main housing along the longitudinal axis between a covering position that is distal to the working end of the needle and an injecting position that is proximal to the working end of the needle, the needle shield being spring biased to be normally placed in the covering position and being opaque to substantially block user view of the working end of the needle in the covering position, the needle shield having a cam or follower which rotatably and longitudinally interfaces with a respective follower or cam of the rotator during a compression stroke of the needle shield from the covering position to the injecting position; and a removable cap positioned to cover the working end of the needle, wherein the needle assembly or the drug cartridge is movable along the longitudinal axis to a priming position via engagement with the cap or plunger rod, respectively, to cause the internal end of the needle to penetrate the membrane and fluidly connect with the drug cartridge to prime the needle with the FSH solution, wherein during the compression stroke the needle shield moves to the injecting position and rotates the rotator to rotatably engage the plunger rod and cause the plunger rod to move to one of the elements of the seven or fewer discrete dosing positions and compress the movable plunger to deliver a corresponding discrete dose amount of FSH solution from the working end of the needle, wherein the user steps needed to place the unpackaged device from the lock position to a ready-to-use position are four or fewer.