AUTO-INJECTOR

• US 20130190721A1
• Filed: 10/06/2011
• Published: 07/25/2013
• Est. Priority Date: 10/08/2010
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Kemp, Thomas Mark, Ekman, Matthew
• Granted Patent: US 9,283,326 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• 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 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3232 Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means
• 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 refers to an auto-injector and to a method for operating it, the auto-injector comprising of a tubular chassis; a carrier subassembly comprising a tubular carrier slidably arranged in the chassis, the carrier containing 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; a wrap-over trigger sleeve arranged over the distal end (D) of the auto-injector; the trigger sleeve extending at least almost over the whole length of the auto-injector; a control spring arranged around the carrier; first interlock means 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; second interlock means arranged for releasing the drive spring for injection; third interlock means arranged for coupling the chassis to the carrier for joint axial translation relative to the trigger sleeve; and fourth interlock means arranged for coupling a distal end of the control spring to either the carrier for needle retraction or to the trigger sleeve otherwise.

Claims

1-15. -15. (canceled)

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

a tubular chassis,

a carrier subassembly comprising a tubular carrier slidably arranged relative to the chassis and partially arranged in the chassis, the carrier containing 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 locked for joint axial translation with the carrier,

a wrap-over trigger sleeve arranged over the distal end (D) of the auto-injector, the trigger sleeve extending at least almost over the whole length of the auto-injector,

a control spring arranged around the carrier,

first interlock means 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 trigger sleeve,

second interlock means arranged for releasing the drive spring for injection when the carrier has at least almost reached an injection depth during needle insertion,

third interlock means arranged for coupling the chassis to the carrier for joint axial translation relative to the trigger sleeve, wherein the third interlock means are arranged to decouple the chassis from the carrier upon translation of the trigger sleeve in proximal direction (P) relative to the chassis thus releasing the control spring for needle insertion,

fourth interlock means arranged for coupling a distal end of the control spring to either the carrier for needle retraction or to the trigger sleeve otherwise.

17. Auto-injector according to claim 16, characterized in that the first interlock means comprises a proximal collar for transmitting load of the proximal end of the control spring, the proximal collar arranged to be engaged on a thread on the carrier in an initial state, the proximal collar having a pin arranged to be splined to a first longitudinal groove in the trigger sleeve in the initial state so as to prevent rotation of the proximal collar and couple it to the carrier, wherein the first longitudinal groove is arranged to release the pin upon translation of the chassis and carrier in proximal direction (P) under load of the control spring when the auto-injector is removed from the injection site thereby allowing rotation and translation of the proximal collar relative to the carrier under load of the control spring and subsequent abutting of the proximal collar against the chassis.

18. Auto-injector according to claim 16, characterized in that the second interlock means comprises two resilient arms arranged distally on the plunger, the resilient arms exhibiting a thrust face for the drive spring, wherein a first boss protrudes from a distal trigger end face of the trigger sleeve in proximal direction (P), wherein the first boss is arrangeable between the two resilient arms thus preventing them from flexing towards each other, wherein protrusions are arranged in the carrier for respectively catching one of the resilient arms in a manner to prevent translation of the plunger in proximal direction (P), wherein the boss is arranged to be removed from between the resilient arms thus allowing them to flex inwards due to their ramped engagement to the protrusions under load of the drive spring and to release the plunger when the carrier has at least almost reached the injection depth during needle insertion.

19. Auto-injector according to claim 16, characterized in that the third interlock means comprises at least one resilient clip on the chassis engageable in a respective aperture in the carrier, wherein at least one second boss is arranged in the trigger sleeve for outwardly supporting the resilient clip so as to prevent the resilient clip from flexing outwards and disengaging the carrier from the chassis, wherein the second boss is arranged to be removed from behind the resilient clip on translation of the trigger sleeve in proximal direction (P) relative to the chassis thereby allowing the resilient clip to flex outwards due to its ramped engagement with the carrier under load of the control spring.

20. Auto-injector according to claim 16, characterized in that the fourth interlock means comprise a distal collar for transmitting load of the distal end of the control spring, the distal collar and the trigger sleeve having a bayonet fitting restricting translation of the distal collar relative to the trigger sleeve in distal direction (D) in at least one locked angular position of the distal collar and allowing translation of the distal collar relative to the trigger sleeve in distal direction (D) in at least one unlocked angular position of the distal collar, wherein the respective angular position is determined by a splined engagement of the distal collar with the carrier, wherein the distal collar is arranged to be rotated into the unlocked angular position upon translation of the chassis and carrier in proximal direction (P) under load of the control spring when the auto-injector is removed from the injection site thereby allowing translation of the distal collar relative to the trigger sleeve under load of the control spring in distal direction (D) and subsequent abutting of the distal collar against an external shoulder on the carrier for retraction.

21. Auto-injector according to claim 20, characterized in that the bayonet fitting comprises at least one circumferentially arranged third boss on the inner surface of the trigger sleeve and a corresponding number of circumferentially arranged fourth bosses on the outer surface of the distal collar, wherein in the locked angular position corresponding pairs of third bosses and fourth bosses are essentially aligned in a manner to abut against each other thus preventing translation of the distal collar in distal direction (D), wherein in the unlocked angular position corresponding pairs of third bosses and fourth bosses become misaligned in a manner to allow translation of the distal collar in distal direction (D).

22. Auto-injector according to claim 20, characterized in that the splined engagement comprises at least one longitudinal spline on the carrier engaged with a respective second longitudinal groove on the inner surface of the distal collar, wherein the spline is essentially parallel for maintaining the distal collar in the locked angular position but ends with a lead screw thread near its distal end for rotating the distal collar into the unlocked angular position.

23. Auto-injector according to claim 16, characterized in that a detent mechanism is provided for opposing translation of the chassis relative to the trigger sleeve for triggering needle insertion.

24. Method for operating an auto-injector, the auto-injector comprising:

a tubular chassis,

a carrier subassembly comprising a tubular carrier slidably arranged relative to the chassis and partially arranged in the chassis, the carrier containing 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 locked for joint axial translation with the carrier,

a wrap-over trigger sleeve arranged over the distal end (D) of the auto-injector, the trigger sleeve extending at least almost over the whole length of the auto-injector,

a control spring arranged around the carrier,

first interlock means for coupling a proximal end of the control spring to either the carrier or to the chassis,

second interlock means arranged for locking the drive spring,

third interlock means arranged for coupling the chassis to the carrier,

fourth interlock means arranged for coupling a distal end of the control spring to either the carrier or to the trigger sleeve,

the method comprising the steps of;

coupling the proximal end of the control spring to the carrier by the first interlock means, preventing release of the drive spring by the second interlock means, preventing decoupling of the chassis from the carrier by the third interlock means and coupling the distal end of the control spring to the trigger sleeve in an initial state,

translating the trigger sleeve in proximal direction (P) relative to the chassis against the force of the control spring when the proximal end (P) of the auto-injector is being pushed against an injection site,

disengaging the third interlock means when the trigger sleeve is at least almost fully translated thereby releasing the control spring for advancing the carrier subassembly for needle insertion,

releasing the drive spring by the second interlock means when the needle at least almost reaches an injection depth during needle insertion, thereby allowing the drive spring to advance the plunger and the stopper for at least partially delivering the medicament (M),

translating the trigger sleeve in distal direction (D) under load of the control spring relative to the carrier subassembly on removal of the auto-injector from the injection site,

decoupling the proximal end of the control spring from the carrier and coupling it to the chassis by the first interlock means and decoupling the distal end of the control spring from the trigger sleeve and coupling it to the carrier by the fourth interlock means when the trigger sleeve reaches a defined position relative to the carrier,

retracting the carrier subassembly into the chassis into a needle safe position under load of the control spring.

25. Method according to claim 24, characterized in that the first interlock means comprises a proximal collar for transmitting load of the proximal end of the control spring, wherein the proximal collar is engaged on a thread on the carrier in the initial state, wherein a pin on the proximal collar is splined to a first longitudinal groove in the trigger sleeve in the initial state so as to prevent rotation of the proximal collar and couple it to the carrier, wherein upon translation of the chassis and carrier in proximal direction (P) during removal of the auto-injector from the injection site the pin travels beyond a proximal end of the first longitudinal groove, thereby the control spring to rotate and translate the proximal collar relative to the carrier into a position where proximal collar abuts against the chassis.

26. Method according to claim 24, characterized in that the second interlock means comprises two resilient arms arranged distally on the plunger, the resilient arms exhibiting a thrust face for the drive spring, wherein a first boss protrudes from a distal trigger end face of the trigger sleeve in proximal direction (P), wherein the first boss is arranged between the two resilient arms in the initial state thus preventing them from flexing towards each other, wherein protrusions are arranged in the carrier for respectively catching one of the resilient arms in a manner to prevent translation of the plunger in proximal direction (P), wherein the boss is removed from between the resilient arms when the carrier has at least almost reached the injection depth during needle insertion thus allowing the resilient arms to flex inwards due to their ramped engagement to the protrusions under load of the drive spring and to release the plunger.

27. Method according to claim 24, characterized in that the third interlock means comprises at least one resilient clip on the chassis engaged in a respective aperture in the carrier in the initial state, wherein at least one second boss is arranged in the trigger sleeve for outwardly supporting the resilient clip so as to prevent the resilient clip from flexing outwards and disengaging the carrier from the chassis in the initial state, wherein the second boss is removed from behind the resilient clip on translation of the trigger sleeve in proximal direction (P) relative to the chassis, wherein the resilient clip is subsequently flexed outwards due to its ramped engagement with the carrier under load of the control spring.

28. Method according to claim 24, characterized in that the fourth interlock means comprise a distal collar for transmitting load of the distal end of the control spring, the distal collar and the trigger sleeve having a bayonet fitting restricting translation of the distal collar relative to the trigger sleeve in distal direction (D) in at least one locked angular position of the distal collar and allowing translation of the distal collar relative to the trigger sleeve in distal direction (D) in at least one unlocked angular position of the distal collar, wherein the respective angular position is determined by a splined engagement of the distal collar with the carrier, wherein the distal collar is in the locked angular position in the initial state, wherein the distal collar is rotated into the unlocked angular position by the splined engagement upon translation of the chassis and carrier in proximal direction (P) when the auto-injector is removed from the injection site wherein the distal collar is subsequently translated in distal direction (D) relative to the trigger sleeve under load of the control spring into a position where it abuts against an external shoulder on the carrier which is then translated in distal direction (D) for retraction.

29. Method according to claim 28, characterized in that the bayonet fitting comprises at least one circumferentially arranged third boss on the inner surface of the trigger sleeve and a corresponding number of circumferentially arranged fourth bosses on the outer surface of the distal collar, wherein in the initial state the bayonet fitting is set in the locked angular position by essentially aligning corresponding pairs of third bosses and fourth bosses in a manner to abut against each other thus preventing translation of the distal collar in distal direction (D), wherein upon translation of the chassis and carrier in proximal direction (P) when the auto-injector is removed from the injection site the distal collar is rotated by the splined engagement into the unlocked angular position, thereby misaligning corresponding pairs of third bosses and fourth bosses in a manner to allow translation of the distal collar in distal direction (D).

30. Method according to claim 28, characterized in that the splined engagement comprises at least one longitudinal spline on the carrier engaged with a respective second longitudinal groove on the inner surface of the distal collar, wherein the second longitudinal groove is guided on an essentially parallel part of the spline in the initial state for maintaining the distal collar in the locked angular position wherein the second longitudinal groove is moved along the spline upon translation of the chassis and carrier in proximal direction (P) when the auto-injector is removed from the injection site and enters a lead screw thread near a distal end of the spline for rotating the distal collar into the unlocked angular position.