Auto injector with separate needle injection

• US 9,775,948 B2
• Filed: 09/10/2012
• Issued: 10/03/2017
• Est. Priority Date: 09/09/2011
• Status: Active Grant

• 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): Bosworth, Kami A
• Application Number:
  US14/343,920
• Publication Number:
  US 20140207106A1
• Time in Patent Office: 1,849 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

An auto injector having sequential control of needle insertion and dose injection is disclosed. A syringe with a needle is movably positioned in a 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. A plunger rod tube has at least one locking member configured to normally lock a plunger rod to the plunger rod tube. A syringe driver applies a force to the syringe to move the syringe together with plunger rod tube, plunger rod and plunger rod driver from the first position to the second position. In the second position, the locking member is unlocked and releases the plunger rod to thereby activate the plunger rod driver to advance the plunger rod in the syringe for delivering of at least one dose of medicament.

Claims

1. An auto injector having sequential control of needle insertion and dose injection, the auto injector having a housing and comprising structures accommodated in the housing, the structures including:

a syringe with a needle, the syringe 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,

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

a plunger rod tube having at least a first deflectable locking member and a second deflectable locking member configured to interact with a plunger rod stop to normally lock the plunger rod to the plunger rod tube,

a syringe driver configured to apply a force to the syringe thereby moving the syringe from the first position to the second position, the syringe driver being further configured to advance the plunger rod tube with the plunger rod to the second position,

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

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

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

wherein the plunger rod tube further comprises the at least first and second deflectable locking members configured to sequentially engage with the plunger rod stop,

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

wherein the at least first and second deflectable locking members are arranged with respect to each other at different distances along a movement direction of the plunger rod tube, and

wherein the structures are accommodated in the housing before and during needle insertion and during dose injection.

2. An auto injector according to claim 1, wherein the plunger rod tube and the syringe are interconnected so that the plunger rod tube cannot move in a longitudinal direction with respect to the syringe and vice versa.

3. An auto injector according to claim 2, wherein the at least first and second deflectable locking members are configured to deflect upon being aligned with the first and second openings in the housing.

4. An auto injector according to claim 1, wherein the plunger rod driver comprises a plunger rod spring,

wherein the plunger rod spring at one end is fixedly connected to the plunger rod tube.

5. An auto injector according to claim 1, wherein the plunger rod driver applies its force directly onto the plunger rod.

6. An auto injector according to claim 1, wherein the housing further accommodates a syringe tube for holding the syringe, and wherein the syringe is locked between the syringe tube and the plunger rod tube.

7. An auto injector according to claim 1, wherein the plunger rod driver is provided inside the plunger rod tube, and wherein the syringe driver is provided outside the plunger rod tube.

8. An auto injector according to claim 1, wherein an inner surface of the housing prevents the at least first and second deflectable locking members from deflecting,

wherein, upon release of the plunger rod, the plunger rod driver advances the plunger rod within the syringe such that the plunger rod stop is able to pass the at least first and second deflectable locking members.

9. An auto injector according claim 1, wherein the plunger rod stop has an angled surface pressing against an angular surface of the at least first and second deflectable locking members when in a locked position, wherein the at least first and second deflectable locking members are hinged to the plunger rod tube in a downward position with respect to the movement of the plunger rod.

10. An auto injector according to claim 1, wherein the auto injector is reloadable.

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

12. An auto injector according to claim 10, 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 further activation of the plunger rod driver.

13. An auto injector according to claim 12, wherein a second activation of the plunger rod driver follows a reload of the auto injector, and a repeated movement of the syringe with the needle from the first position to the second position.

14. An auto injector according to claim 10, wherein a reload operation is configured to reverse operation of the auto injector.

15. An auto injector according to claim 1, further comprising a syringe lock configured to lock the syringe in the first position, and a skin sensor configured to release the syringe lock upon engagement with skin of a user wherein the skin sensor is activated by pressing the skin sensor onto the skin of the user,

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 a lateral motion of the skin sensor into angular motion of the syringe lock.

16. An auto injector according to claim 15, wherein the syringe with the needle rests on a ledge in the syringe lock to lock the syringe in the first position and wherein the angular motion of the syringe lock releases the syringe with the needle.

17. An auto injector according to claim 1, wherein the plunger rod tube comprises a plunger rod tab, the plunger rod tab being configured to move in a syringe lock guide slot of a syringe lock from a released position adjacent a ledge to a syringe lock end stop,

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

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

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

19. An auto injector according to claim 1, wherein the syringe with the needle comprises a syringe tube co-axially encompassing the syringe and the 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 syringe with the needle is configured to rest on a syringe lock ledge when an intermediate component tab is provided in a first or second handle slot,

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

20. An according to claim 1, wherein the auto injector housing further comprises an indicator for indicating a “

ready”

state and a “

not ready”

state,

wherein the “

ready”

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

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

wherein the skin sensor is configured to extend over the length of the needle as the needle is withdrawn after a dose has been delivered,

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

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

22. 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 with the needle for engaging sloped teeth on the plunger rod,

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

23. An auto injector according to claim 1, wherein the syringe with the needle 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.

24. An auto injector according to claim 1, wherein the auto injector is re-usable,

wherein the syringe with the needle is replaceable.

25. An auto injector having sequential control of needle insertion and dose injection, the auto injector having a housing and comprising structures accommodated in the housing, the structures including:

a syringe with a needle, the syringe 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,

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

a plunger rod tube having at least a first deflectable locking member and a second deflectable locking member configured to interact with a plunger rod stop to normally lock the plunger rod to the plunger rod tube,

a first spring configured to apply a force to the syringe thereby moving the syringe from the first position to the second position, the first spring being further configured to advance the plunger rod tube with the plunger rod to the second position,

a second spring 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,

wherein the at least first and second locking members are configured to be unlocked upon advancing the plunger rod tube with the plunger rod to the second position thereby unlocking the plunger rod from the plunger rod tube and allowing the second spring to advance the plunger rod in the syringe,

wherein the plunger rod tube further comprises the at least first and second deflectable members configured to sequentially engage with the plunger rod stop,

wherein the housing comprises a first opening and a second opening configured to align with the at least first and second deflectable members, respectively, when the syringe is in the second position,

wherein the at least first and second deflectable locking members are arranged with respect to each other at different distances along a movement direction of the plunger rod tube, and

wherein the structures are accommodated in the housing before and during needle insertion and during dose injection.

26. A method of delivering a dose of medicament using an auto injector, wherein the auto injector has a housing for accommodation of a syringe assembly, the syringe assembly comprising a syringe with a needle, the syringe 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, a plunger rod configured to be advanced in the syringe for delivering the dose of medicament, a plunger rod tube having at least a first deflectable locking member and a second deflectable locking member configured to interact with a plunger rod stop to lock the plunger rod to the plunger rod tube when not delivering medicament,

the method comprising the steps of:

activating a syringe driver to apply a force to the syringe thereby moving the syringe from the first position to the second position, and further advancing the plunger rod tube with the plunger rod to the second position,

in the second position, unlocking the at least first and second deflectable locking members and activating a plunger rod driver to apply a force to the plunger rod to thereby advance the plunger rod in the syringe for delivering at least one dose of medicament,

wherein the syringe driver is a first spring and the plunger rod driver is a second spring,

wherein the at least first and second deflectable locking members are configured to sequentially engage with the plunger rod stop,

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

wherein the at least first and second deflectable locking members are arranged with respect to each other at different distances along a movement direction of the plunger rod tube, and

wherein the syringe assembly, the plunger rod, and the plunger rod tube are accommodated in the housing before and during needle insertion and during dose injection.