Auto-Injector

• US 20130324935A1
• Filed: 02/16/2012
• Published: 12/05/2013
• Est. Priority Date: 02/18/2011
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Brereton, Simon Francis, Kemp, Thomas, Burnell, Rosie, Ekman, Matthew
• Granted Patent: US 9,352,090 B2
• Time in Patent Office: Days
• US Class Current: 604/198
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user

Abstract

The invention relates to an auto-injector for administering a dose of a liquid medicament, comprising:

• • a tubular chassis,
  • a carrier subassembly comprising a tubular carrier slidably arranged partially inside the chassis, the carrier adapted to contain a syringe with a hollow injection needle, a drive spring and a plunger for forwarding load of the drive spring to a stopper of the syringe, wherein the syringe is lockable for joint axial translation with the carrier,
  • a control spring arranged around the carrier,
  • a needle insertion control mechanism for coupling a proximal end of the control spring to either the carrier for advancing it for needle insertion or to the chassis for needle retraction depending on the relative axial position of the carrier and the chassis,
    wherein the needle insertion control mechanism comprises a first collar biased by the control spring in a proximal direction, wherein at least one resilient beam is proximally arranged on the first collar, wherein respective recesses are arranged in the carrier and case, wherein a transversal extension of a head of the resilient beam is wider than a gap between the carrier and the chassis causing the head of the resilient beam to abut a distal face on the recess in the chassis while being prevented from deflecting in an inward direction by the carrier or to abut a distal face on the recess in the carrier while being prevented from deflecting in an outward direction by the chassis thereby forwarding load from the control spring to the carrier for needle insertion, wherein the resilient beam is arranged to be switched between the chassis and the carrier by ramped engagement of the head to the distal faces under load of the control spring depending on the relative longitudinal position between the chassis and the carrier.

Claims

1-15. -15. (canceled)

16. Auto-injector for administering a dose of a liquid medicament, comprising:

a tubular chassis,

a carrier subassembly comprising a tubular carrier slidably arranged partially inside the chassis, the carrier adapted to contain a syringe with a hollow injection needle, a drive spring and a plunger for forwarding load of the drive spring (8) to a stopper of the syringe, wherein the syringe is lockable for joint axial translation with the carrier,

a control spring arranged around the carrier,

a needle insertion control mechanism for coupling a proximal end of the control spring to either the carrier for advancing it for needle insertion or to the chassis for needle retraction depending on the relative axial position of the carrier and the chassis,

wherein the needle insertion control mechanism comprises a first collar biased by the control spring in a proximal direction, wherein at least one resilient beam is proximally arranged on the first collar, wherein respective recesses are arranged in the carrier and case, wherein a transversal extension of a head of the resilient beam is wider than a gap between the carrier and the chassis causing the head of the resilient beam to abut a distal face on the recess in the chassis while being prevented from deflecting in an inward direction by the carrier or to abut a distal face on the recess in the carrier while being prevented from deflecting in an outward direction by the chassis thereby forwarding load from the control spring to the carrier for needle insertion, wherein the resilient beam is arranged to be switched between the chassis and the carrier by ramped engagement of the head to the distal faces under load of the control spring depending on the relative longitudinal position between the chassis and the carrier.

17. Auto-injector according to claim 16, characterized in that the resilient beam (20.1) is shaped as an arrowhead having an outward sixth ramp and an inward ninth ramp.

18. Auto-injector according to claim 16, characterized in that the distal face on the recess in the chassis is shaped as a distal seventh ramp and/or that the distal face on the recess in the carrier is shaped as a distal tenth ramp.

19. Auto-injector according to claim 16, characterized in that the gap between the carrier and the chassis is wider than a shaft of the resilient beam between the first collar and the head, wherein an aperture is arranged proximally from the recess in the chassis allowing the head of the resilient beam to disengage from the carrier and to deflect into the aperture when the carrier has been sufficiently translated relative to the chassis in the proximal direction thus switching the proximal end of the control spring to the chassis for allowing needle retraction.

20. Auto-injector according to claim 16, characterized in that the resilient beam is connected to the first collar by a living hinge.

21. Auto-injector according to claim 16, characterized in that the resilient beam is initially coupled to the chassis, wherein the auto-injector is arranged to be actuated by translating the carrier in the proximal direction until the resilient beam switches to the carrier translating it further under load of the control spring.

22. Auto-injector according to claim 21, characterized in that an elongate tubular case is arranged, wherein the chassis and the carrier are telescoped within the case, wherein the case is biased in the distal direction and arranged to translate in the proximal direction against the bias when the chassis is pressed against an injection site, wherein a first rib on the case is arranged to prevent the head of the resilient beam from entering the aperture when the chassis is pressed against the injection site, wherein on removal from the injection site and subsequent translation of the case in the distal direction the first rib is moved so as to allow the head of the resilient beam to disengage from the carrier and deflect into the aperture.

23. Auto-injector according to claim 16, characterized in:

a trigger button arranged distally or laterally in or on the case,

a plunger release mechanism arranged for releasing the plunger for injection when the carrier has at least almost reached an injection depth during needle insertion,

a detent mechanism arranged for coupling the chassis to the carrier for joint axial translation relative to the case, wherein the detent mechanism is arranged to decouple the chassis from the carrier upon actuation of the trigger button thus allowing the carrier to move relative to the chassis so as to cause the needle insertion control mechanism to switch the proximal end of the control spring to the carrier for needle insertion, and

a syringe retraction control mechanism arranged for coupling a distal end of the control spring to either the carrier for needle retraction or to the case otherwise.

24. Auto-injector according to claim 23, characterized in that the plunger release mechanism comprises at least one resilient arm on the carrier arranged to being a ramped engagement to the plunger so as to disengage them under load of the drive spring, wherein a peg protrudes from a distal end face of the trigger button in the proximal direction in a manner to support the resilient arm preventing disengagement of the carrier from the plunger and thus release of the drive spring when the carrier is in a distal position, wherein the trigger button is arranged to remain in position relative to the case when the carrier is translated for advancing the needle so as to pull the resilient arm away from the peg thus allowing deflection of the resilient arm due to the ramped engagement under load of the drive spring for disengaging the plunger from the carrier and releasing the drive spring for drug delivery when the carrier has reached a predefined position during needle advancement.

25. Auto-injector according to claims 23, characterized in that the detent mechanism comprises a resilient beam on the chassis and a rhomboid ramp member on the carrier, the resilient beam being essentially straight when relaxed and having a first beam head arranged to interact in a ramped engagement with a proximal fourth ramp or a distal fifth ramp on the rhomboid ramp member in such a manner that application of a translative force on the carrier relative to the chassis in the proximal direction with the first beam head engaged to the fourth ramp deflects the resilient beam in one transversal direction when a predetermined value of the translative force, at least depending on the resilience of the resilient beam, is overcome so as to allow the first beam head to travel along one transversal side of the rhomboid ramp member on continued relative translation of the components, wherein the resilient beam is allowed to relax when the first beam head has reached the fifth ramp thereby engaging it in a manner that application of a translative force on the carrier in the distal direction deflects the resilient beam in the other transversal direction when a predetermined value of the translative force, at least depending on the resilience of the resilient beam, is overcome so as to allow the first beam head to travel along the other transversal side of the rhomboid ramp member on continued translation of the carrier).

26. Auto-injector according to claim 23, characterized in that the case is arranged to lock the detent mechanism prior to being translated in the proximal direction relative to the chassis when the chassis is being pressed against an injection site, wherein the case when translated into an advanced position in the proximal direction is arranged to unlock the detent mechanism rendering it operable.

27. Auto-injector according to claim 23, characterized in that the distally arranged trigger button is at least initially coupled to the carrier, wherein the case is arranged to abut the trigger button in the initial state preventing depression of the trigger button, wherein on translation of the case into the advanced position when the chassis is being pressed against the injection site the trigger button remains coupled to the carrier thus emerging from the case so as to allow depression for starting an injection cycle.

28. Auto-injector according to claim 23, characterized in that the syringe retraction control mechanism comprises a second collar bearing against the distal end of the control spring and having a resilient proximal beam with a second beam head having an inward boss, wherein the second beam head is arranged to be in a ramped engagement with a second case detent in the case in a manner ramping the second beam head in the inward direction under load of the control spring in the distal direction, wherein the inward boss is arranged to inwardly abut the carrier for preventing inward deflection of the second beam head and keep the second collar locked to the case, wherein a third recess is arranged in the carrier for allowing the inward boss to be inwardly deflected on translation of the case in the distal direction relative to the carrier on removal of the auto-injector from the injection site.

29. Auto-injector according to claim 23, characterized in that the trigger button is arranged distally, wherein the case is arranged as a wrap-over sleeve trigger having a closed distal end face covering the trigger button, wherein in an initial state a clearance is provided between the distal end face of the sleeve trigger and the trigger button allowing for some travel of the sleeve trigger against the bias of the control spring in the proximal direction in a first phase before abutting the trigger button.

30. Auto-injector according to claim 16, characterized in that a releasable noise component is provided, capable of, upon release, generating an audible and/or tactile feedback to a user, wherein the noise component is arranged to be released when the plunger reaches a position relative to the syringe in which the stopper is located in proximity of a proximal end of the syringe, and wherein the released noise component impacts on a housing component indicating the end of the injection.