Medical injection device comprising a secondary safety limiter

• US 9,950,118 B2
• Filed: 03/15/2013
• Issued: 04/24/2018
• Est. Priority Date: 04/20/2012
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Kjeldsen, Bastian G., Mouridsen, Brian, Radmer, Jim
• Primary Examiner(s): FARRAR, LAUREN PENG
• Application Number:
  US14/395,716
• Publication Number:
  US 20150105732A1
• Time in Patent Office: 1,866 Days
• CPC Class Codes: A61M 2005/2026 Semi-automatic, e.g. user activated piston is assisted by additional source of energy
• CPC Class Codes: A61M 2005/2407 from the rear
• CPC Class Codes: A61M 2005/2492 via snap connection
• CPC Class Codes: A61M 2005/31518 designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
• CPC Class Codes: A61M 2005/3154 limiting maximum permissible dose
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/31501 Means for blocking or restricting the movement of the rod or piston A61M5/5013 takes precedence
• CPC Class Codes: A61M 5/31535 Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
• CPC Class Codes: A61M 5/31541 Means preventing setting of a dose beyond the amount remaining in the cartridge
• CPC Class Codes: A61M 5/3155 by rotational movement of dose setting member, e.g. during setting or filling of a syringe
• CPC Class Codes: A61M 5/31553 without axial movement of dose setting member
• CPC Class Codes: A61M 5/3157 Means providing feedback signals when administration is completed A61M5/20 takes precedence
• CPC Class Codes: A61M 5/31583 based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
• CPC Class Codes: A61M 5/31585 performed by axially moving actuator, e.g. an injection button
• CPC Class Codes: A61M 5/31593 Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
• CPC Class Codes: F04C 2270/0421 Controlled or regulated

Abstract

The present invention relates to an injection device (1) for setting and injecting set doses from a held drug cartridge (10). The injection device (1) comprises a housing (110,120,130, 140), a piston rod (800), a rotatable driver (500, 700) and a dose setting device (400). The dose setting device (400) comprises a predetermined stop to limit the amount of an expelled dose corresponding to the amount of a set dose. A secondary stop limiter includes first (700) and second (270) components and a secondary stop track follower (950) arranged between the first (700) and second (270) components. If the predetermined stop fails to stop the driver (500, 700) at the end of injection, the secondary stop track follower (950) moves towards a safety stop (708) to prevent the driver (500, 700) from rotating further.

Claims

1. A medical injection device for setting and injecting set doses from a held drug cartridge, comprising:

a housing defining proximal and distal ends,

a dose setting arrangement including a dose setting device that is moved in a first direction away from a predetermined primary stop in accordance with the size of a set dose and that moves back to the predetermined primary stop during injection of the set dose, the predetermined primary stop being configured for being fixedly arranged relative to the housing,

a piston rod adapted to translate relative to the housing in a distal direction in order to expel a set dose,

a driver coupled to the piston rod, the driver being adapted to rotate during dose injection to cause the piston rod to translate relative to the housing, and

a mechanism adapted for coupling rotational movement of the dose setting device with rotational movement of the driver such that the driver exclusively rotates when the dose setting device moves back towards the predetermined stop during injection of the set dose,

wherein the injection device further defines;

a secondary stop comprising;

a first component that rotates around a first axis as the driver rotates during injection but remains rotationally fixed relative to the housing during dose setting, the first component having a first track disposed thereon,

a second component that is arranged coaxially with the first component for rotation around the first axis, wherein the second component rotates as the dose setting device rotates during dose setting and wherein the second component is rotatably fixed relative to the housing during dose injection, the second component having a second track disposed thereon, and

a secondary stop track follower arranged between the first component and the second component, the secondary stop track follower being in engagement with the first track and in engagement with the second track, wherein the first track and the second track are configured to cause the secondary stop track follower to move along the first axis when the first component and the second component rotate relative to each other, and wherein, if the predetermined primary stop fails to stop the driver at the end of injection, the secondary stop track follower moves towards a safety stop to prevent the driver from rotating further.

2. An injection device as defined in claim 1, wherein one of the first track and the second track forms a thread and wherein the other one of the first track and the second track forms an axial track.

3. An injection device as defined in claim 1, wherein both the first track and second track form threads and wherein the lead of the first track is different than the lead of the second track.

4. An injection device as defined in claim 1, wherein at least one of the first track and the second track forms a thread and wherein the safety stop is arranged fixedly relative to the at least one thread.

5. An injection device as defined in claim 1, wherein the secondary stop track follower does not engage the piston rod.

6. An injection device as defined in claim 1, wherein the first component is the driver.

7. An injection device as defined in claim 1, wherein the safety stop forms a rotational stop surface adapted to abut a rotational stop surface provided on the secondary stop track follower to prevent further rotation of the first component beyond the safety stop.

8. An injection device as defined in claim 1, wherein the injection device includes a dosage selector coupled to the dose setting device for operating the dose setting device and an injection activator adapted to be activated to inject the set dose.

9. An injection device as defined in claim 1, wherein the injection device defines a first clutch arrangement arranged between the dose setting device and the second component, wherein the first clutch arrangement is engaged during dose setting so that the second component rotates as the dose setting device rotates, and wherein the first clutch arrangement is disengaged during dose injection to enable the dose setting device to rotate independently of the second component.

10. An injection device as defined in claim 9, wherein the injection device defines a second clutch arrangement arranged between the first component and the housing, wherein the second clutch arrangement is engaged during dose setting so that the first component is prevented from rotating during dose setting, and wherein the second clutch arrangement is disengaged during dose injection to enable the first component to rotate relative to the housing.

11. An injection device as defined in claim 1, wherein the injection device further comprises a stored energy source, the stored energy source being configured to drive rotation of the driver when the injection activator is activated.

12. An injection device as defined in claim 11, wherein the stored energy source comprises energy sufficient to drive the piston rod for expelling the entire useable contents of the cartridge.

13. An injection device as defined in claim 1, wherein at least a piston engaging end of the piston rod extends along the first axis, wherein the driver defines a drive nut that rotates around the first axis and wherein the dose setting device is adapted to rotate around a second axis, the second axis being offset from the first axis by a distance and wherein the driver further defines a drive member rotatable around the second axis, the drive member being coupled to the drive nut so that the drive nut rotates as the drive member rotates.

14. An injection device as defined in claim 1, wherein the piston rod is a flexible piston rod having a first end extending in parallel with the first axis and adapted to engage a piston of a held cartridge and wherein the second end of the piston rod is adapted to be flexed away from the first axis.

15. An injection device as defined in claim 1, wherein the longitudinal axis of a held cartridge defines a second axis, the second axis being offset from the first axis by a distance, wherein the driver defines a drive nut that rotates around the second axis and wherein the driver further defines a drive member rotatable around the first axis, the drive member being coupled to the drive nut so that the drive nut rotates as the drive member rotates wherein the dose setting device is adapted to rotate around the first axis, and wherein said first component is a component that rotates as the drive member rotates.