A one-time use device to deliver preservative-free follicle stimulating hormone (FSH) solution is disclosed. The device includes a needle covered by a sliding needle shield, which covers the needle in all modes of the device. The device can be placed into a ready-to-use position in four or fewer use
A one-time use device to deliver preservative-free follicle stimulating hormone (FSH) solution is disclosed. The device includes a needle covered by a sliding needle shield, which covers the needle in all modes of the device. The device can be placed into a ready-to-use position in four or fewer user steps. The device has a knob for setting a desired dose of FSH. The knob includes longitudinally spaced elements respectively corresponding to the lock position and the seven or fewer discrete dosing positions. The device locks after one use and cannot be reused thereafter.
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1. A method for using a single-use device for self-delivery of follicle stimulating hormone solution, the method comprising: using a single-use device for self-delivery of follicle stimulating hormone (FSH) solution, the single use device comprising:an elongated main housing with distal and proximal
1. A method for using a single-use device for self-delivery of follicle stimulating hormone solution, the method comprising: using a single-use device for self-delivery of follicle stimulating hormone (FSH) solution, the single use 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 the 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 holder 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; anda 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. 2. The method of claim 1, wherein the knob is rotatable with respect to the main housing between the lock position and a prime position. 3. The method of claim 2, wherein the knob includes a longitudinally spaced priming element corresponding to the prime position, the priming element being located between the lock position and the seven or fewer discrete dosing positions. 4. The method of claim 3, wherein rotating the knob to or past the prime position rotates the plunger rod from the lock position and incrementally moves the plunger rod along the longitudinal axis between the element corresponding to the lock position and the priming element. 5. The method of claim 4, wherein the plunger rod is incrementally moved along the longitudinal axis to move the drug cartridge into the needle assembly and cause the membrane to be punctured by the internal end of the needle and prime the needle with the FSH solution. 6. The method of claim 5, wherein the user steps needed to place the unpackaged device from the lock position to the ready-to-use position consist of: priming the needle with the FSH solution by rotating the knob from the lock position, past the priming position, to one of the seven or fewer discrete dosing positions; andremoving the needle cap. 7. The method of claim 6, wherein the knob is visually marked with discrete positions indicating the seven or fewer discrete dosing positions. 8. The method of claim 7, wherein the priming position is not marked on the knob. 9. The method of claim 6, wherein distal movement of the main housing with respect to the needle shield held against relatively immobile tissue causes the compression stroke. 10. The method of claim 1, wherein the needle assembly includes a hub attached to the needle, the hub being threadably engaged with a retainer member of the needle assembly. 11. The method of claim 10 wherein the removable cap is rotatably engaged with the retainer member, and wherein rotation of the removable cap disengages the removable cap from the device and also moves the hub in a proximate direction with respect to the retainer member and accordingly causes the membrane to be punctured by the internal end of the needle and prime the needle with the FSH solution. 12. The method of claim 11, wherein the user steps needed to place the unpackaged device from the lock position to the ready-to-use position consist of: priming the needle with the FSH solution by removing the needle cap; androtating the knob from the lock position to one of the seven or fewer discrete dosing positions. 13. The method of claim 12, wherein distal movement of the main housing with respect to the needle shield held against relatively immobile tissue causes the compression stroke. 14. The method of claim 1, wherein the drug cartridge is 1.5 ml in volume. 15. The method of claim 14, wherein the plunger rod is configured to deliver a maximum dose of the FSH solution within five seconds after the needle shield is placed in the injecting position. 16. The method of claim 1, wherein the needle shield includes a locking element which locks to the rotator or main housing during a decompression stroke of the needle shield from the injecting position to a recovering position to recover the working end of the needle, and wherein the needle shield is immovable with respect to the main housing after moving to the recovering position. 17. The method of claim 1, wherein the plunger rod contacts one of the elements of the seven or fewer discrete dosing positions with enough force to cause an audible click to be heard by the user. 18. The method of claim 1, wherein the FSH solution does not contain benzyl alcohol or m-cresol. 19. The method of claim 1, wherein the needle shield completely blocks the user's view of the working end of the needle in the covering position when the distal end of the needle shield is held against the user's tissue before and after the compression stroke occurs.
Bendek Antonio A. ; Burbank ; III John E. ; Bush ; Jr. Charles L. ; Gabel Jonathan B. ; Giambattista Lucio ; Hoeck Roger W. ; Taylor Malcolm E., Medication delivery pen having an improved clutch assembly.
Morrison, Jr., William Harold; Atterbury, William Godwin; Bowes, William Anton; Dennis, Jr., Joseph Daniel; Madland, Steven Michael, Automatic injection device.
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