Actuation mechanisms for dual chamber mixing syringes

• US 9,539,393 B2
• Filed: 06/04/2014
• Issued: 01/10/2017
• Est. Priority Date: 06/04/2013
• Status: Active Grant

• Current Assignee: UNL Holdings, LLC
• Original Assignee: Unitract Syringe Pty Limited (Unilife Corp.)
• Inventors: Johannesson, Robert E., Dungar, Peter J., Miller, Molly M., Felsovalyi, Flora
• Primary Examiner(s): Hayman, Imani
• Assistant Examiner(s): Ponton, James D
• Application Number:
  US14/296,194
• Publication Number:
  US 20140358091A1
• Time in Patent Office: 951 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/31598 having multiple telescopically sliding coaxial pistons encompassing volumes for components to be mixed
• CPC Class Codes: A61M 2005/3231 Proximal end of needle captured or embedded inside piston head, e.g. by friction or hooks
• CPC Class Codes: A61M 2005/3236 Trigger provided at the distal end, i.e. syringe end for mounting a needle
• CPC Class Codes: A61M 5/2066 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/284 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/31596 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3234 Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user

Abstract

An automatic mixing device, an actuating device having integrated plunger and configured to be removably mounted to the automatic mixing device, and a retractable syringe having the automatic mixing device are provided. The actuating device has an initially compressed spring and a trigger member that is rotatable to initiate spring decompression to drive depression of a mixing plunger seal of the automatic mixing device. Another seal located in an outer chamber of the mixing device is capable of axial movement upon depression of the mixing plunger, from a first position in sealing engagement with one or more apertures in an inner barrel to a second position intermediate the apertures and vents in an outer barrel. This allows depression of the mixing plunger to force a first substance from the outer chamber through the apertures to mix with a second substance in an inner chamber of the inner barrel. The mixed substance in the inner barrel is then delivered by the syringe with subsequent needle retraction.

Claims

1. An actuating device removably mountable to an automatic mixing syringe, said syringe including an inner barrel, an outer barrel, an outer chamber between the inner barrel and the outer barrel, a deliver plunger seal disposed in the inner barrel, and at least one mixing plunger seal, disposed in the outer chamber, the actuating device comprising a housing releasably connectable to the syringe, a rotatable trigger member, a biasing member, a delivery plunger engageable with the delivery plunger seal of the syringe, and a mixing plunger releasably engaged with the trigger member in an initially locked state and engageable with the at least one mixing plunger seal of the syringe, wherein said trigger member is operable to initiate said biasing member to facilitate depression of said mixing plunger when engaged with said at least one mixing plunger seal, wherein the mixing plunger comprises at least one prong, and wherein the trigger member comprises at least one slot member, and wherein in the initially locked state the at least one prong initially engages the at least one slot member and is rotatable out of engagement with the at least one slot member to initiate said biasing member to facilitate depression of said mixing plunger when engaged with said at least one mixing plunger seal to thereby mix a plurality of substances in said syringe.

2. The actuating device of claim 1, wherein the housing comprises at least one abutment and the delivery plunger comprises at least one channel, wherein in the initially locked state, the at least one abutment is not aligned with the at least one channel to thereby prevent axial travel of the delivery plunger.

3. An actuating device removably mountable to an automatic mixing syringe, said syringe including an inner barrel, an outer barrel, an outer chamber between the inner barrel and the outer barrel, a delivery plunger seal disposed in the inner barrel, and at least one mixing plunger seal disposed in the outer chamber, the actuating device comprising a housing releasably connectable to the syringe, a rotatable trigger member, a biasing member, a delivery plunger engageable with the delivery plunger seal of the syringe, and a mixing plunger releasably en aged with the trigger member in an initially locked state and engageable with the at least one mixing plunger seal of the syringe, wherein said trigger member is operable to initiate said biasing member to facilitate depression of said mixing plunger when engaged with said at least one mixing plunger seal, wherein the housing comprises at least one abutment and the delivery plunger comprises at least one channel, wherein in the initially locked state, the at least one abutment is not aligned with the at least one channel to thereby prevent axial travel of the delivery plunger, and wherein rotation of the trigger member can rotate the delivery plunger to align the at least one abutment of the housing with the at least one channel in the delivery plunger to thereby permit axial travel of the delivery plunger.

4. The actuating device of claim 3, wherein the mixing plunger comprises at least one prong.

5. The actuating device of claim 3, wherein the trigger member comprises at least one slot member.

6. The actuating device of claim 3, wherein the trigger member comprises at least one trigger lock member.

7. The actuating device of claim 3, wherein the housing comprises at least one housing lock member.

8. The actuating device of claim 3, wherein the biasing member is initially retained in an energized state between the trigger member and the mixing plunger.

9. The actuating device of claim 8, wherein upon disengagement of the mixing plunger from the trigger member, the biasing member expands from its energized state to translate the mixing plunger axially.

10. The actuating device of claim 9, wherein axial translation of the mixing plunger bears upon and axially translates the at least one mixing plunger seal of the syringe.

11. The actuating device of claim 10, wherein axial translation in the distal direction of the mixing plunger can cause the mixing plunger to bear upon and axially translate said at least one mixing plunger seal of the syringe.

12. The actuating device of claim 3, wherein the biasing member is initially retained within an interior chamber of the trigger member.

13. An actuating device removably mountable to an automatic mixing syringe, said syringe including an inner barrel, an outer barrel, an outer chamber between the inner barrel and the outer barrel, a delivery plunger seal disposed in the inner barrel, and at least one mixing plunger seal disposed in the outer chamber, the actuating device comprising a housing releasably connectable to the syringe, a rotatable trigger member including at least one trigger lock member, a biasing member, a delivery plunger engageable with the delivery plunger seal of the syringe, and a mixing plunger releasably engaged with the trigger member in an initially locked state and engageable with the at least one mixing plunger seal of the syringe, wherein said trigger member is operable to initiate said biasing member to facilitate depression of said mixing plunger when engaged with said at least one mixing plunger seal, wherein the housing comprises at least one housing lock member and wherein following rotation of the trigger member, the at least one trigger lock member can engage the at least one housing lock member to prevent further rotation of the trigger member.

14. An automatic mixing syringe comprising an inner barrel, an outer barrel, an outer chamber between the inner barrel and the outer barrel, a delivery plunger seal disposed in the inner barrel, a needle assembly including a retractable needle engageable by the delivery plunger seal and at least one biasing member operable to retract the retractable needle, at least one mixing plunger seal disposed in the outer chamber, and an actuating device, the outer barrel and the inner barrel being disposed in a substantially coaxial or concentric relationship, the actuating device comprising a housing mounted to the outer barrel, a rotatable trigger member, a biasing member, a delivery plunger engaged or engageable with the delivery plunger seal, and a mixing plunger releasably engaged with the trigger member in an initially locked state and engaged or engageable with the at least one mixing plunger seal wherein said trigger member is operable to initiate said biasing member to facilitate depression of said mixing plunger when engaged with said at least one mixing plunger seal, wherein the needle assembly comprises a push bar which is engageable by the delivery plunger seal to activate retraction of the retractable needle by the at least one biasing member.

15. An automatic mixing syringe comprising an inner barrel, an outer barrel, an outer chamber between the inner barrel and the outer barrel, a needle assembly including a retractable needle and a retractable needle body, a delivery plunger seal disposed in the inner barrel and including a needle-engaging portion configured to engage the retractable needle body, at least one mixing plunger seal disposed in the outer chamber, and an actuating device, the outer barrel and the inner barrel being disposed in a substantially coaxial or concentric relationship, the actuating device comprising a housing mounted to the outer barrel, a rotatable trigger member, a biasing member, a delivery plunger engaged or engageable with the delivery plunger seal, a mixing plunger releasably engaged with the trigger member in an initially locked state and engaged or engageable with the at least one mixing plunger seal, wherein said trigger member is operable to initiate said biasing member to facilitate depression of said mixing plunger when engaged with said at least one mixing plunger seal, wherein the biasing member of the actuating device is operable to activate retraction of the retractable needle body when engaged by the needle-engaging portion of the delivery plunger seal.

16. The automatic mixing syringe of claim 15, wherein the at least one mixing plunger seal is axially moveable within the outer chamber.

17. The automatic mixing syringe of claim 15, wherein the at least one mixing plunger seal includes a proximal seal and a distal seal that are moveable within the outer chamber.

18. The automatic mixing syringe of claim 15, wherein the inner barrel comprises at least one fluid path through which a first mixing substance in the outer chamber can enter an inner chamber in the inner barrel to thereby form a mixture with a second mixing substance.

19. The automatic mixing syringe of claim 15, which comprises a sealing membrane that maintains sterility of the automatic mixing syringe prior to operation.

20. The automatic mixing syringe of claim 19, wherein the sealing membrane is manually removable, removable automatically by axial translation of the mixing plunger and/or pierceable by axial translation of the delivery plunger.

21. An automatic mixing syringe comprising an inner barrel, an outer barrel, an outer chamber between the inner barrel and the outer barrel, a delivery plunger seal disposed in the inner barrel, at least one mixing plunger seal disposed in the outer chamber, a needle assembly, and an actuating device, the outer barrel and the inner barrel being disposed in a substantially coaxial or concentric relationship, the actuating device comprising a housing mounted to the outer barrel, a rotatable trigger member, a biasing member, a removable proximal cover, a delivery plunger engaged or engageable with the delivery plunger seal, and a mixing plunger releasably engaged with the trigger member in an initially locked state and engaged or engageable with the at least one mixing plunger seal, said trigger member being operable to initiate said biasing member to facilitate depression of said mixing plunger when engaged with said at least one mixing plunger seal, wherein the removable proximal cover is operable to rotate the trigger member to initiate said biasing member to facilitate depression of said mixing plunger when engaged with said at least one mixing plunger seal.

22. An automatic mixing syringe comprising an inner barrel, an outer barrel, an outer chamber between the inner barrel and the outer barrel, a delivery plunger seal disposed in the inner barrel, at least one mixing plunger seal disposed in the outer chamber, a needle assembly, a removable distal cover, the outer barrel and the inner barrel being disposed in substantially coaxial or concentric relationship, the actuating device comprising a housing mounted to the outer barrel, a rotatable trigger member, a biasing member, a delivery plunger engaged or engageable with the delivery plunger seal, and a mixing plunger releasably engaged with the trigger member in an initially locked state and engaged or engageable with the at least one mixing plunger seal, said trigger member being operable to initiate said biasing member to facilitate depression of said mixing plunger when engaged with said at least one mixing plunger seal, wherein the removable distal cover is operable to remove a needle shield covering a needle.

23. An automatic mixing syringe comprising:

a needle assembly comprising a retractable needle with a retractable needle body;

a delivery plunger seal having a needle-engaging portion configured to engage the retractable needle body of the retractable needle;

at least one mixing plunger seal; and

an actuating device comprising a housing releasably connectable to a barrel of the automatic mixing syringe, a rotatable trigger member, a biasing member, a delivery plunger, and a mixing plunger releasably engaged with the trigger member in an initially locked state and engageable with the at least one mixing plunger seal of the automatic mixing syringe, wherein said trigger member is operable to initiate said biasing member to facilitate depression of said mixing plunger when engaged with said at least one mixing plunger seal;

wherein the biasing member of the actuating device is operable to activate retraction of the retractable needle body when engaged by the needle-engaging portion of the delivery plunger seal.