Two-stage reconstituting injector

• US 8,251,947 B2
• Filed: 05/02/2007
• Issued: 08/28/2012
• Est. Priority Date: 05/03/2006
• Status: Active Grant

• Current Assignee: Antares Pharma Incorporated
• Original Assignee: Antares Pharma Incorporated
• Inventors: KraMer, Thomas E., Sadowski, Peter L.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Flick, Jason
• Application Number:
  US12/299,274
• Publication Number:
  US 20090292240A1
• Time in Patent Office: 1,945 Days
• Field of Search: 604/82
• US Class Current: 604/82
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/2474 with movable piercing means, e.g. ampoule remains fixed or steady
• CPC Class Codes: A61M 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• 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 5/2066 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/2466 by piercing without internal pressure increase A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: A61M 5/31596 comprising means for injection of two or more media, e.g. by mixing
• 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 5/3204 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 injector for injecting a medicament into a patient. The injector includes a container defining a first chamber, which contains a fluid therein, and a second chamber. The injector also includes an injection conduit configured for directing the fluid fired from the container into the patient. A transfer mechanism is operable by a user to transfer the fluid from the first chamber to the second chamber in a first stage of operation, and a firing mechanism is operable by the user for firing the fluid from the second chamber through the injection conduit in a second stage of operation. An energy source is in powering association with the firing mechanism to drive firing mechanism in the first and second stages.

Claims

1. An injector for injecting a medicament into a patient, comprising:

a transfer and firing device associable with a container that defines a first and second chambers, the transfer and firing device being operable to transfer a fluid from the first chamber to the second chamber in a first stage of operation and being operable for firing the fluid from the second chamber through an injection conduit, associated with the container, in a second stage of operation;

a trigger device configured to block operation of the transfer and firing device to end the first stage of operation, the trigger device in blocking association with the transfer and firing device is operable manually in a second triggering stage which causes a firing mechanism to initiate the second stage of operation; and

a transfer control that is manually operable to initiate operation of the transfer and firing device in the first stage of operation,

wherein the injection conduit has a position that is fluidly incommunicated with the second chamber, the transfer and firing device configured to fluidly communicate the injection conduit with the second chamber in the first stage of operation,

wherein the injection conduit comprises a communicating needle portion, the transfer control operable to relatively move the communicating needle portion with respect to the second chamber to pierce the container to fluidly communicate the second chamber with the communicating needle portion in the first stage of operation.

3. The injector of claim 1 or 2, wherein the transfer and firing device comprises a firing ram that is movable over a first throw in the first stage of operation and a second throw in the second stage of operation and causes moves the fluid from the first chamber to the second chamber in the first stage of operation and from the second chamber through the injection conduit in the second stage of operation.

4. The injector of claim 3, wherein the trigger device is configured to block movement of the ram beyond the first throw, the trigger device being actuatable to release the ram to travel over the second throw.

5. The injector of claim 1 or 2, further comprising a retractable guard that is movable between:

a protecting position in which the injection conduit is disposed within the guard; and

an injecting position in which an injection needle portion of the injection conduit is exposed for injection of the fluid in the patient;

wherein the trigger device is configured for operating the transfer and firing device in the second stage after the retractable guard is retracted from the protecting position.

6. The injector of claim 5, wherein the retractable guard is operably associated with the device to cause an injection trigger mechanism to operate the firing mechanism when the guard is retracted to the injecting position.

7. The injector of claim 1 or 2, wherein the injection conduit comprises an injecting needle portion disposed and configured to pierce the skin of the patient for assisting the injection of the fluid in the second stage.

8. The injector of claim 7, wherein the transfer and firing device are configured for delivering the fluid by jet injection to an injection site within the patient tissue remote from the injecting needle.

9. The injector of claim 1, wherein the transfer control comprises a cap associated with the container and disposed to cover the injection conduit prior to the first stage of operation, wherein the cap is configured such that removal of the cap from covering the injection conduit initiates the first stage of operation.

10. The injector of claim 9, further comprising a cap release in locking association with the cap to prevent operation thereof, and being positionable in a release position in which the cap release releases the cap to permit operation thereof in the first stage of operation.

11. The injector of claim 1 or 2, wherein the second chamber comprises a medicament, and the fluid comprises a diluent configured for dissolving or suspending the medicament therein for injection into the patient.

12. The injector of claim 1 or 2, further comprising the injection conduit and the container, which container contains the fluid in the first chamber and is associated with the injection conduit for injecting the fluid therethrough in the second stage of operation.

13. The injector of claim 1 or 2, further comprising an energy source in powering association with the transfer and firing device to drive the transfer and firing device in both the first and second stages.

2. An injector for injecting a medicament into a patient, comprising:

a transfer and firing device associable with a container that defines a first and second chambers, the transfer and firing device being operable to transfer a fluid from the first chamber to the second chamber in a first stage of operation and being operable for firing the fluid from the second chamber through an injection conduit, associated with the container, in a second stage of operation;

a trigger device configured to block operation of the transfer and firing device to end the first stage of operation, the trigger device in blocking association with the transfer and firing device is operable manually in a second triggering stage which causes a firing mechanism to initiate the second stage of operation; and

a transfer control that is manually operable to initiate operation of the transfer and firing device in the first stage of operation

wherein the transfer control comprises a cap disposed for covering the injection conduit and being associated with the transfer and firing device such that removal of the cap from covering the injection conduit initiates the first stage of operation of the transfer mechanism.

14. The injector of claim 2, wherein the injection conduit has a position that is fluidly incommunicated with the second chamber, the transfer and firing device configured and to fluidly communicate the injection conduit with the second chamber in the first stage of operation.

15. The injector of claim 14, further comprising a transfer control that is manually operable to initiate operation of the transfer and firing device in the first stage of operation, wherein the injection conduit comprises a communicating needle portion, the transfer control operable to relatively move the communicating needle portion with respect to the second chamber to pierce the container to fluidly communicate the second chamber with the communicating needle portion in the first stage of operation.

16. The injector of claim 15, wherein the injection conduit comprises an injecting needle portion disposed and configured to pierce the skin of the patient for assisting the injection of the fluid in the second stage.

17. The injector of claim 16, wherein the transfer and firing device are configured for delivering the fluid by jet injection to an injection site within the patient tissue remote from the injecting needle.

18. The injector of claim 15, further comprising a cap release in locking association with the cap to prevent operation thereof, and being positionable in a release position in which the cap release releases the cap to permit operation thereof in the first stage of operation.

19. An injector for injecting a medicament into a patient, comprising:

a transfer mechanism associable with a container that defines a first and second chambers, the transfer mechanism operable by a user to transfer a fluid from the first chamber to the second chamber in a first stage of operation;

a cap disposed for covering an injection conduit that is associated with the container, the cap being associated with the transfer mechanism such that a movement of the cap initiates the first stage of operation of the transfer mechanism; and

a firing mechanism operable by the user for firing the fluid from the second chamber through the injection conduit in a second stage of operation;

wherein the firing mechanism includes a needle guard that has a protective position disposed for covering a needle of the injection conduit, and an injecting position exposing the needle, and the cap covering the injection conduit covers the needle and needle guard;

wherein the needle guard is configured for causing the firing mechanism to fire the fluid when moved to the retracted position.

21. The injector of claim 19 or 20, wherein:

the cap is retained covering the injection conduit until the transfer mechanism is operated in the first stage of operation, and the cap is separable from the injection conduit once the transfer mechanism is operated in the first stage of operation.

22. The injector of claim 21, wherein the injection conduit comprises a communicating needle portion, a transfer control being operable to relatively move the communicating needle portion with respect to the fluid chamber to pierce the container adjacent a needle hub to fluidly communicate the fluid chamber with the communicating needle portion.

23. The injector of claim 19, further comprising the injection conduit, which includes the needle.

24. The injector of claim 19 or 20, further comprising the container, which contains the fluid in the first chamber.

25. The injector of claim 24, wherein:

the injection conduit comprises a needle;

firing mechanism includes a needle guard that has a protective position covering the needle, and an injecting position exposing the needle; and

the cap covering the injection conduit covers the needle and needle guard.

26. The injector of claim 19, wherein the cap is configured such that proximal movement of the cap, opposite a direction of the firing of the fluid, initiates the first stage of operation.

27. The injector of claim 19, further comprising a housing associated with the cap such that rotation of the cap with respect to the housing causes proximal movement of the cap with respect thereto, the cap being configured such that the proximal movement thereof initiates the first stage of operation.

28. The injector of claim 19 or 20, wherein said movement of the cap comprises a removal of the cap from covering the injection conduit.

29. The injector of claim 19 or 20, further comprising an energy source in powering association with the transfer and firing mechanisms to drive transfer and firing mechanisms in both the first and second stages.

30. The injector of claim 19 or 20, further comprising an injection trigger mechanism operably associated with the firing mechanism to operate the firing mechanism to initiate the second stage.

20. An injector for injecting a medicament into a patient, comprising:

a transfer mechanism associable with a container that defines a first and second chambers, the transfer mechanism operable by a user to transfer a fluid from the first chamber to the second chamber in a first stage of operation;

a cap disposed for covering an injection conduit that is associated with the container, the cap being associated with the transfer mechanism such that a movement of the cap initiates the first stage of operation of the transfer mechanism;

a firing mechanism operable by the user for firing the fluid from the second chamber through the injection conduit in a second stage of operation; and

a housing associated with the cap such that rotation of the cap with respect to the housing causes proximal movement of the cap with respect thereto, the cap being configured such that the proximal movement thereof initiates the first stage of operation;

wherein at least the housing or the cap has a partial thread in threaded engagement with the other such that a partial rotation of the cap with respect to the housing causes said proximal movement of the cap that initiates the first stage of operation, and further rotation of the cap releases the threaded engagement for releasing the cap from the housing.

31. The injector of claim 20, wherein:

the firing mechanism includes a needle guard that has a protective position disposed for covering a needle of the injection conduit, and an injecting position exposing the needle; and

the cap covering the injection conduit covers the needle and needle guard.

32. The injector of claim 31, further comprising the injection conduit, which includes the needle.

33. The injector of claim 31, wherein the needle guard is configured for causing the firing mechanism to fire of the fluid when moved to the refracted position.