Re-loadable auto injector

• US 10,357,608 B2
• Filed: 09/10/2012
• Issued: 07/23/2019
• Est. Priority Date: 09/09/2011
• Status: Expired due to Fees

• Current Assignee: Merck Patent GmbH (Merck & Co., Inc.)
• Original Assignee: Merck Patent GmbH (Merck & Co., Inc.)
• Inventors: Bechmann, Soeren, Madsen, Flemming, Johansen, Esben W.
• Primary Examiner(s): Lee, Brandy S
• Application Number:
  US14/343,881
• Publication Number:
  US 20140221974A1
• Time in Patent Office: 2,507 Days
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/202 cocking means, e.g. to bias the main drive spring of an injector
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/3267 Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• 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 5/3157 Means providing feedback signals when administration is completed A61M5/20 takes precedence
• CPC Class Codes: A61M 5/3204 Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
• 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

A reloadable auto injector wherein a syringe assembly is movably positioned between a first position in which the needle is accommodated inside a housing and a second position in which the needle protrudes outside the housing. The assembly comprises a syringe, a plunger rod and a plunger rod driver configured to apply a force to the plunger rod to advance the plunger rod in the syringe for delivering at least one dose of medicament. A syringe driver is configured to apply a force to the assembly thereby moving the assembly from the first position to the second position. A reload handle may be connected to the assembly so that user operation of the reload handle retracts the assembly to the first position and simultaneously reload the syringe driver to thereby ready the auto injector for delivering a further dose of medicament. The plunger rod driver is not re-activated.

Claims

1. A reloadable auto-injector with a housing for accommodation of structures, the structures comprising:

a syringe assembly comprising a syringe with a needle, the syringe assembly being movably positioned in the housing between a first position in which the needle is accommodated inside the housing and a second position in which the needle protrudes outside the housing,

the syringe assembly further comprising

a plunger rod configured to be advanced in the syringe for delivering at least one dose of medicament,

a plunger rod driver being configured to apply a force to the plunger rod to advance the plunger rod in the syringe for delivering at least one dose of medicament,

a syringe driver configured to apply a force to the syringe assembly thereby moving the syringe assembly from the first position to the second position,

the auto injector further comprising a reload handle configured to reload the auto injector for injecting a further dose of medicament,

wherein the reload handle is connected to the syringe assembly so that user operation of the reload handle is configured to retract the syringe assembly to the first position and to simultaneously reload the syringe driver to thereby ready the auto injector for delivering the further dose of medicament,

wherein the syringe driver and the plunger driver are separate driver means,

wherein the syringe driver comprises a resilient device,

the auto injector further comprising a syringe lock configured to lock the syringe assembly in the first position, and a skin sensor configured to release the syringe lock upon engagement with the skin of a user wherein the skin sensor is activated by pressing the skin sensor onto a user'"'"'s skin,

wherein the activation of the skin sensor is configured to cause an upward movement of the skin sensor whereby a skin sensor angled surface is configured to engage with a syringe lock angled surface translating the lateral motion of the skin sensor into angular motion of the syringe lock,

wherein the syringe assembly rests on a ledge in the syringe lock to lock the syringe assembly in the first position and wherein the angular motion of the syringe lock releases the syringe assembly,

wherein the syringe assembly comprises a syringe assembly tab, the syringe assembly tab being configured to move in a syringe lock guide slot from a released position adjacent the ledge to a syringe lock end stop, and

wherein the syringe assembly is moved from the first position to the second position when the syringe assembly tab travels in the syringe lock guide slot from the released position to the syringe lock end stop.

2. An auto injector according to claim 1, wherein forward motion of the syringe assembly in the second position is restricted by the syringe assembly tab engaging the syringe lock end stop.

3. An auto injector according to claim 1, wherein a skin sensor driver upon removal of the auto injector from a user'"'"'s skin is configured to push the skin sensor forward to shield the needle after each injection cycle,

wherein the skin sensor has a locked forward position and an unlocked forward position,

wherein the skin sensor is unlocked in the forward position upon operation of the reload handle.

4. An auto injector according to claim 1, wherein the syringe assembly comprises a syringe tube co-axially encompassing the syringe and a plunger rod tube co-axially encompassing the plunger rod, the syringe tube and the plunger rod tube being interconnected via syringe tube connectors engageable with plunger rod tube connectors,

wherein the plunger rod driver in one end is fixedly connected to a back end of the plunger rod tube.

5. An auto injector according to claim 1, wherein the plunger rod is locked while the syringe assembly is moved from the first position to the second position.

6. An auto injector according to claim 1, wherein the plunger rod is configured to be released when the syringe assembly is in the second position thereby activating the plunger rod driver to move the plunger rod forward.

7. An auto injector according to claim 1, wherein the plunger rod driver is configured to move the plunger a first distance upon a first activation of the plunger rod driver, and a further distance upon a second activation of the plunger rod driver, wherein the second activation of the plunger rod driver follows a reload of the auto injector, and a repeated movement of the syringe assembly from the first position to the second position.

8. An auto injector according to claim 1, having sequential control of needle insertion and dose injection,

wherein the auto injector comprises a plunger rod tube having at least one locking member configured to interact with a plunger rod stop to normally lock the plunger rod to the plunger rod tube,

wherein the housing is configured to unlock the locking member and release the plunger rod from the plunger rod tube when the syringe assembly is advanced to the second position, thereby activating the plunger rod driver to advance the plunger rod in the syringe for delivering of at least one dose of medicament,

wherein the locking member comprises at least one deflectable member and wherein the housing is configured to allow for the at least one deflectable member to enable deflection away from the plunger rod when the syringe and the plunger rod tube is advanced to the second position,

wherein the plunger rod tube and the syringe are interconnected so that the plunger rod tube cannot move with respect to syringe and vice versa,

wherein the housing has an opening configured to be aligned with the at least first deflectable member when the plunger rod tube is advanced to the second position,

wherein the at least first deflectable member is configured to deflect upon being aligned with the window in the housing,

wherein the plunger rod driver comprises a plunger rod spring,

wherein the plunger rod spring in one end is fixedly connected to the plunger rod tube,

wherein the plunger rod driver applies the driving force directly onto the plunger rod.

9. An auto injector according to claim 8, wherein the housing further accommodates a syringe tube for holding the syringe, and wherein the syringe having a syringe flange is locked between the syringe tube and the plunger rod tube,

wherein the plunger rod driver is provided inside the plunger rod tube, and wherein the syringe driver is provided outside the plunger rod tube,

wherein an inner surface of the housing prevents the at least one deflectable locking member from deflecting, wherein, upon release of the plunger rod, the plunger rod driver advances the plunger rod within the syringe in that the plunger rod stop is able to pass the deflected locking member,

wherein plunger rod stop has an angled surface normally pressing against an angular surface of the deflectable locking member, wherein the at least one deflectable locking member is hinged to the plunger rod tube in a downward position with respect to the movement of the plunger rod,

wherein the plunger rod tube comprises at least a first and a second locking member configured to engage with at least a first and a second plunger rod stop,

wherein the housing comprises at least a first and a second opening configured to align with the at least first and second locking member, respectively, when the syringe is the second position.

10. An auto injector according to claim 1, wherein the auto injector is configured to deliver two or more separate doses of medicament.

11. An auto injector according to claim 1, wherein the user operation of the reload handle comprises a rotational movement.

12. An auto injector according to claim 1, wherein the reload handle is configured for a rotational movement, the auto injector further comprising an intermediate component transferring the rotational movement of the reload handle to a translational movement of at least the syringe assembly,

wherein the intermediate component has a tab configured to move along an inclined surface of the reload handle upon operation of the reload handle, wherein a complete operation of the reload handle forces the tab over an inclined surface top and into a second reload handle slot,

wherein the syringe assembly is configured to rest on a syringe lock ledge when the intermediate component tab reaches the second handle slot,

wherein the second reload handle slot has an inclined surface to allow for continuous reloading to the auto injector,

wherein the second reload handle slot allows for longitudinal movement only to thereby prevent further reload of the auto injector.

13. An auto injector according to claim 1, wherein the reload operation is configured to reverse the operation of the auto injector,

wherein the reload operation is configured to reverse syringe driver, syringe lock and skin sensor.

14. An auto injector according to claim 1, wherein the auto injector housing further comprises an inspection window for indicating a “

ready”

state and a “

done”

state, wherein the “

ready”

state indicates a first rotational position of the syringe lock in which position the syringe assembly is locked in the first position.

15. An auto injector according to claim 1, wherein the skin sensor extends over the length of the needle when the syringe assembly is in the first position to hide the needle from a user'"'"'s view.

16. An auto injector according to claim 1, wherein the skin sensor is configured to extend over the length of the needle immediately after a dose has been delivered.

17. An auto injector according to claim 1, wherein the auto injector further comprises a sound generator configured to emit a sound while dosing,

wherein the sound generator comprises a ratchet mechanism,

wherein the ratchet mechanism comprises flexible arms positioned with the syringe assembly for engaging sloped teeth on the plunger rod,

wherein the ratchet mechanism allows for forward movement only of the plunger rod.

18. An auto injector according to claim 1, wherein the syringe assembly further comprises an anti-tamper component, wherein the anti-tamper component comprises a protection mechanism to ensure that backward movement of the plunger rod is prevented.

19. An auto injector according to claim 1, wherein the auto injector is re-usable, and wherein the syringe assembly is replaceable.

20. An auto injector according to claim 1, wherein the at least one dose of medicament comprises adrenaline.

21. A reloadable auto-injector with a housing for accommodation structure, the structures comprising:

a syringe assembly comprising a syringe with a needle, the syringe assembly being movably positioned in the housing between a first position in which position the needle is accommodated inside the housing and a second position in which position the needle protrudes outside the housing,

the syringe assembly further comprising

a plunger rod driver being configured to apply a force to the plunger rod to advance the plunger rod in the syringe for delivering at least one dose of medicament,

a syringe driver configured to apply a force to the syringe assembly thereby moving the syringe from the first position to the second position,

a reload handle configured to reload the auto injector for injecting a further dose of medicament,

wherein the reload handle is connected to the syringe assembly so that user operation of the reload handle is configured to retract the syringe assembly over a top edge of the reload handle to the first position and to simultaneously reload the syringe driver.

22. An auto injector according to claim 21, wherein the at least one dose of medicament comprises adrenaline.

23. A method of operating a reloadable auto injector, the auto injector comprising a housing for accommodation of

a syringe assembly comprising a syringe with a needle, the syringe assembly being movably positioned in the housing between a first position in which position the needle is accommodated inside the housing and a second position in which position the needle protrudes outside the housing, the syringe assembly further comprising a plunger rod driver being configured apply a force to a plunger rod to advance the plunger rod in the syringe for delivering at least one dose of medicament, the housing further accommodating a syringe driver configured to apply a force to the syringe assembly thereby moving the syringe from the first position to the second position, a skin sensor for activation of the auto injector, syringe lock for locking the syringe assembly in the first position, and a reload handle,

wherein the method comprises the steps of:

activating the skin sensor, wherein the syringe lock is rotated, the syringe assembly is released, the syringe assembly is moved from the first position to the second position, and the plunger rod driver is released to deliver a dose of medicament,

moving the skin sensor to a forward position to cover the needle, wherein the skin sensor is locked in the forward position,

reloading the auto injector by operation of the reload handle, wherein the syringe assembly is moved from the second position to the first position, the syringe driver is reloaded, the syringe assembly is locked in the first position and the skin sensor is unlocked,

whereby the auto injector is ready to deliver a further dose of medicament.

24. The method according to claim 23, wherein the at least one dose of medicament comprises adrenaline.