Claims for Patent: 7,241,278

Summary for Patent: 7,241,278

Title:	Injection device
Abstract:	An injection device for injection of set doses of medicine from a cartridge, in which syringe a dose is set by screwing a nut up along a threaded piston rod, whereby a dose setting drum, which carries on its cylindrical surface along a helix a scale of which a number corresponding to the set dose is shown in a window in the housing of the syringe, and an injection button, which is elevated over the end of the syringe, are moved axially a distance which is larger than the axial movement of the nut. A gear wheel gear transmission is established between the nut and the injection button.
Inventor(s):	Moller; Claus Schmidt (Fredensborg, DK)
Assignee:	Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:	10/667,040
Patent Claims:	1. A drug delivery device comprising: a piston rod having at least one threaded portion (4); a dose dial sleeve (17) threadedly engaged with a portion of the device and having a scale indicative of dose sizes and wherein the dose dial sleeve is rotatable during a dose setting operation so that it can be rotated to a position where a predetermined dose is indicated on the scale; a drive sleeve (20) for driving the piston rod; and a clutch (21), which is comprised of one or more components (33, 32), that releasably couples the dose dial sleeve (17) and the drive sleeve (20); and wherein: (i) during the dose setting operation the dose dial sleeve (17) and the drive sleeve (20) are coupled by the clutch so that they rotate together; and (ii) during injecting of medication from the device, the dose dial sleeve (17) is decoupled from the drive sleeve (20) and so that it rotates back to an original pre-dose setting position upon completion of the injection but the drive sleeve (20) does not rotate during injecting of medication but instead moves in a longitudinal direction toward an injecting end of the device. 2. The device of claim 1, wherein the drive sleeve is coupled to a gear box that is in turn coupled to the threaded piston rod so that a portion of the longitudinal force exerted by the user that is transmitted to the piston rod is transmitted thru both the drive sleeve and the gear box and wherein the gear box multiples the force. 3. The device of claim 1, wherein a longitudinal force exerted by a user in a direction toward the injecting end of the device is transmitted thru the drive sleeve to the piston rod; and wherein the longitudinal force also acts upon the dose dial sleeve and, as a result of this longitudinal force and longitudinal movement of the drive sleeve, the dose dial sleeve rotates during injecting of medication from the device even though the dose dial sleeve is rotationally decoupled from the drive sleeve during injecting. 4. The apparatus of claim 1, wherein a gear box directly drives the piston rod and wherein the gear box is driven by the drive sleeve, which receives a force from a user pressing on an injection button component that is coupled to or integral with the drive sleeve, thereby making the chive sleeve an indirect but necessary driver of the piston rod. 5. The apparatus of claim 1, wherein the piston rod has the same pitch has pitch of the dose dial sleeve. 6. The apparatus of claim 1, wherein the piston rod has a different thread configuration from that of the dose dial sleeve. 7. The apparatus of claim 1, wherein the pitch of the dose dial sleeve differs from that of the piston rod. 8. A drug delivery device and drive mechanism comprising: a housing (1); a dose dial sleeve (17) threadedly engaged with a threaded portion of the device, the threaded portion being located between a first end of the device and a second end of the device, a drive sleeve (20), and a clutch releasably coupling the dose dial sleeve and the drive sleeve (20), wherein, when the dose dial sleeve (17) and the drive sleeve (20) are coupled during dose setting, both are allowed to rotate with respect to the housing (1), and when the dose dial sleeve (17) and the drive sleeve (20) are de-coupled during dose administration, rotation of the dose dial sleeve (17) with respect to the housing (1) is allowed, while rotation of the drive sleeve (20) with respect to the housing (1) is not allowed, whereby axial movement of the drive sleeve is allowed so that a force is transferred in the longitudinal direction to the first end of the drug delivery device. 9. The apparatus of claim 8, wherein the threaded portion is fixed to the housing so that it cannot rotate with respect to the housing. 10. The apparatus of claim 9, wherein the threaded portion is integral with the housing and wherein the drive further comprises a piston rod having at least a threaded section and wherein the piston rod reacts to a force on the drive sleeve and moves axially to expel drug from the device. 11. The apparatus of claim 9, wherein the device further comprises a piston rod comprising a first portion that is a threaded portion and wherein the piston rod receives a force that is transmitted from one end of the device thru the drive sleeve and as a result of the force the piston rod moves axially to expel drug from the device thru a needle. 12. A drug delivery device and drive mechanism comprising: a housing; a dose dial sleeve threadedly engaged with a portion of the device, the portion being located in between a needle end of the device on which a needle is mountable and an opposite end of the device, a drive sleeve, and wherein the dose dial sleeve and the drive sleeve are releasably coupled together so that: during dosing setting, the dose dial sleeve and the drive sleeve are coupled and both the dose dial sleeve and the drive sleeve rotate together with respect to the housing& and during dose administration: the dose dial sleeve and the drive sleeve are de-coupled and the dose dial sleeve rotates with respect to the housing and the drive sleeve moves axially toward the needle end without rotating with respect to the housing. 13. The device of claim 12, further comprising a piston rod that moves in a direction toward the needle end during dose administration and wherein the piston rod has two different shapes as it is traversed along its length and wherein a clutch is functionally disposed between the dose dial and the drive sleeve to allow for the coupling and uncoupling of the dose dial from the drive sleeve. 14. The device of claim 13, wherein the device further comprises a dose limiter that prevents a dose from being set that is larger than the contents remaining in the device and wherein the drive sleeve is operably coupled to a piston rod and wherein motion of the drive sleeve toward the needle end results in the piston rod moving toward the needle end. 15. The device of claim 13, wherein during dose administration the drive sleeve moves a distance that is greater than the distance the rod moves. 16. A medication delivery device for expelling settable doses of medication, the device comprising: an injection end, a housing, a dose setting drum comprising a scale indicating various dose sizes, and a tubular element that is reversibly rotationally coupled to the dose setting drum so that during dose setting the tubular element and the drum rotate together but during dose administration the tubular element is rotationally decoupled from the drum so that the drum rotates back to a zero position while the tubular element moves longitudinally toward the injection end, the device further comprising a rod that comprises a first threaded portion that extends thru a portion of the housing, the rod coupled to the tubular element so that when the tubular element moves toward the injection end of the device, the rod also moves toward the injection end but wherein the rod travels a different distance than the tubular element, and wherein the tubular element and drum move away from the injection end during dose setting and move axially toward the injection end when a force is applied to either one or applied to both during dose administration. 17. The device of claim 16, wherein the distance the rod travels is less than the distance the tubular element travels. 18. The device of claims 16 or 17, wherein it further comprises a dose setting limiter that prevents a dose that is larger than that remaining in the device from being set and wherein the tubular element is positively precluded from rotating during dose administration. 19. The device of claim 18, wherein the drum is threadedly engaged with the housing. 20. The device of claim 19, wherein the housing has an internal thread. 21. The device of claim 18, wherein the housing has an internal thread and the drum is threadedly engaged with the internal housing thread. 22. A drug delivery device comprising: a piston rod (4); a dose dial sleeve (17) threadedly engaged with a portion of the device and having a scale indicative of dose sizes and wherein the dose dial sleeve is rotatable during a dose setting operation so that it can be rotated to a position where a predetermined dose is indicated on the scale; a drive sleeve (20) for driving the piston rod; and a clutch that releasably couples the dose dial sleeve (17) and the drive sleeve (20); and wherein: (i) during the dose setting operation the dose dial sleeve (17) and the drive sleeve (20) are coupled by the clutch so that they rotate together; and (ii) during injecting of medication from the device, the dose dial sleeve (17) is decoupled from the drive sleeve (20) and so that it rotates back to art original pre-dose setting position upon completion of the injection but the drive sleeve (20) does not rotate during injecting of medication but instead moves in a longitudinal direction toward an injecting end of the device. 23. The device of claim 22, wherein the drive sleeve is operably coupled to the piston rod and transmits a force to the piston rod. 24. The device of claim 23, wherein the piston rod comprises a threaded portion. 25. A drug delivery device comprising: a piston rod; a dose dial threadedly engaged with a portion of the device and having a scale indicative of dose sizes and wherein the dose dial sleeve is rotatable during a dose setting operation so that it can be rotated to a position where a predetermined dose is indicated on the scale; a drive sleeve for transmitting a force that is received at one end of the device to drive the piston rod; and wherein the dose dial and the drive sleeve are releasably coupled so that when the device is in a dose setting mode, the dose dial and drive sleeve rotate together and allow a predetermined dose to be set, and during the injection of the predetermined dose the dose dial and the drive sleeve are decoupled and the dose dial rotates with respect to the drive sleeve and rotates to a zero position upon completion of the injection and the drive sleeve moves axially toward an injecting end of the device and wherein the drive sleeve moves a distance that is greater than a distance that is moved by the piston rod during the injecting of the predetermined dose. 26. The device of claim 25, wherein the piston rod comprises a first section that is threaded. 27. The device of claim 26, wherein a middle portion (112) of the piston rod is unthreaded. 28. The device of claim 27, wherein the device is a medication injection pen.

Details for Patent 7,241,278

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Novo Nordisk Inc.	NOVOLIN R	insulin human	Injection	019938	June 25, 1991		2023-09-22
Novo Nordisk Inc.	NOVOLIN R	insulin human	Injection	019938	June 01, 2018		2023-09-22
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	June 07, 2000		2023-09-22
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	January 19, 2001		2023-09-22

International Patent Family for US Patent 7,241,278

Country	Patent Number	Estimated Expiration
South Africa	200209998
World Intellectual Property Organization (WIPO)	0195959
United States of America	9022991
United States of America	8333739