Reagent preparation assembly

• US 8,973,749 B2
• Filed: 06/29/2011
• Issued: 03/10/2015
• Est. Priority Date: 06/29/2010
• Status: Active Grant

• Current Assignee: Biolyph, LLC
• Original Assignee: Biolyph, LLC
• Inventors: Pearcy, Timothy, Skakoon, James G.
• Primary Examiner(s): SORKIN, DAVID L
• Application Number:
  US13/805,166
• Publication Number:
  US 20130208558A1
• Time in Patent Office: 1,350 Days
• Field of Search: 206/219, 206/222, 604/88
• US Class Current: 206/222
• CPC Class Codes: B01F 33/50112 of the syringe or cartridge type
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/105 using desiccants
• CPC Class Codes: B01L 2400/0478 pistons
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/52 Containers specially adapted for storing or dispensing a reagent B01L3/02 takes precedence; containers for medical or pharmaceutical purposes A61J1/00; containers in general B65D; storing or dispensing test elements G01N33/4875; automated reagent dispensing G01N35/1002
• CPC Class Codes: B01L 3/523 with means for closing or opening
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A reagent preparation assembly includes a body and a reaction chamber adjacent the body, the reaction chamber includes a reagent therein, such as a lyophilized reagent. An access port extends into the reaction chamber, and the access port is configured to receive an instrument. A seal extends across a portion of the reaction chamber and the access port. A reconstitution assembly is movably coupled with the body. The reconstitution assembly includes a plunger, a syringe and a piston. The plunger is movably coupled with the body. The syringe is selectively engaged with the plunger. The syringe includes a solution reservoir containing a solution, and movement of the syringe pierces the seal. The piston is selectively engaged with the plunger, and the piston is movably coupled within the syringe. Movement of the piston pushes the solution into the reaction chamber.

Claims

1. A reagent preparation assembly comprising:

a body;

a reaction chamber adjacent the body, the reaction chamber including a reagent therein,

an access port extending into the reaction chamber, the access port is configured to receive an instrument;

a seal extending across a portion of the reaction chamber and the access port; and

a reconstitution assembly slidably coupled with the body within a syringe passage of the body, the reconstitution assembly comprises;

a plunger slidably coupled with the body,

a syringe selectively engaged with the plunger, the syringe within the syringe passage of the body, the syringe including a solution reservoir containing a solution, and movement of the plunger with the syringe pierces the seal extending across the portion of the reaction chamber, and

a piston selectively engaged with the plunger, the piston within the syringe passage of the body, the piston is movably coupled within the syringe, and movement of the plunger with the piston pushes the solution into the reaction chamber with the reagent therein.

2. The reagent preparation assembly of claim 1, wherein the reaction chamber includes a well for reception of a reagent mixture including the reagent and the solution.

3. The reagent preparation assembly of claim 2, wherein the well tapers to a trough positioned beneath the access port.

4. The reagent preparation assembly of claim 1, wherein the seal extends across a syringe passage, the syringe passage contains the syringe therein.

5. The reagent preparation assembly of claim 4, wherein the seal includes a syringe seal extending across the syringe passage and an access seal extending across the access port, the syringe seal is separate from the access seal.

6. The reagent preparation assembly of claim 4, wherein a vent path extends out of the syringe passage to the exterior of the reagent preparation assembly.

7. The reagent preparation assembly of claim 1, wherein the plunger includes a deflectable tongue and a plunger post, and the deflectable tongue is movable between two configurations:

in a first syringe engaging configuration, the tongue is engaged with the syringe and movement of the plunger moves the syringe, and

in a second piston engaging configuration, the tongue is disengaged from the syringe and the plunger post is engaged with the piston, and movement of the plunger moves the piston relative to the syringe.

8. The reagent preparation assembly of claim 7, wherein the body includes a camming surface configured to engage with the tongue, and movement of the tongue over the camming surface disengages the tongue from the syringe.

9. The reagent preparation assembly of claim 1 comprising a gasket interposed between the body and the reaction chamber.

10. The reagent preparation assembly of claim 9, wherein the syringe is slidably coupled along the gasket and the gasket seals around the syringe.

11. The reagent preparation assembly of claim 1, wherein the syringe includes a piercing surface configured to pierce the seal.

12. A method of making a reagent preparation assembly comprising:

coupling a reaction chamber adjacent to a body, the reaction chamber includes a reagent therein, and an access port extends into the reaction chamber;

coupling a seal across a portion of the reaction chamber, the seal extends across the access port;

slidably coupling a reconstitution assembly with the body within a syringe passage of the body, slidably coupling including;

slidably coupling a plunger with the body,

selectively engaging a syringe with the plunger, the syringe within the syringe passage of the body, the syringe includes a solution reservoir containing a solution, the syringe is configured to pierce a portion of the seal extending across the portion of the reaction chamber with movement of the plunger, and

selectively engaging a piston with the plunger, the piston is within the syringe passage of the body, and the piston is movably coupled within the syringe, movement of the plunger with the piston pushes the solution into the reaction chamber with the reagent therein.

13. The method of claim 12 comprising selectively engaging the plunger with the piston.

14. The method of claim 12 comprising forming a well in the reaction chamber for reception of a reagent mixture including the reagent and the solution.

15. The method of claim 14, wherein forming the well includes forming a trough positioned beneath the access port.

16. The method of claim 12, wherein coupling the seal across the reaction chamber includes coupling a syringe seal across a syringe passage, the syringe passage contains the syringe.

17. The method of claim 16, wherein coupling the seal across the reaction chamber includes coupling an access seal across the access port separate from the syringe seal.

18. The method of claim 12 comprising forming a vent path from a syringe passage containing the syringe, the vent path extends out of the reagent preparation assembly.

19. The method of claim 12 comprising forming a deflectable tongue on the plunger, the deflectable tongue is movable between two configurations:

in a first syringe engaging configuration, the tongue is engaged with the syringe and movement of the plunger moves the syringe, and

in a second piston engaging configuration, the tongue is disengaged from the syringe and movement of the plunger moves the piston relative to the syringe.

20. The method of claim 19 comprising forming a camming surface on the body, the camming surface is configured to deflect the tongue and disengage the tongue from the syringe.

21. The method of claim 12 comprising interposing a gasket between the body and the reaction chamber.

22. The method of claim 21 comprising forming a syringe passage in the gasket configured to slidably seal around the syringe.

23. The method of claim 12 comprising forming a piercing surface on the syringe configured to pierce the seal.

24. A method for using a reagent preparation assembly comprising:

depressing a plunger engaged with a syringe, the syringe within a syringe passage of a body, movement of the syringe piercing a syringe seal in a reaction chamber, the reaction chamber including a reagent therein;

disengaging the plunger from the syringe;

depressing a piston movably coupled within the syringe with further depressing of the plunger, the piston within the syringe passage of the body, depressing the piston moves solution from within the syringe into the reaction chamber with the reagent therein;

mixing the solution with the reagent in the reaction chamber and forming at least one aliquot of a reagent mixture;

piercing an access seal in the reaction chamber; and

drawing at least a portion of the reagent mixture into an instrument positioned in the reaction chamber.

25. The method of claim 24, wherein mixing the solution includes forming multiple aliquots of the reagent mixture.

26. The method of claim 24, wherein disengaging the plunger from the syringe includes deflecting a tongue on the plunger with a camming surface on a body, the plunger is movably coupled with the body, and deflection of the tongue disengages the tongue and the plunger from the syringe.

27. The method of claim 24 comprising seating the syringe along a surface of the reaction chamber.

28. The method of claim 24 wherein mixing the solution with the reagent occurs in a well having a trough in the reaction chamber, the trough is positioned beneath the access seal.

29. The method of claim 24, wherein depressing the plunger engaged with the syringe includes:

opening the reaction chamber to a vent path extending from the reaction chamber to the exterior of the reagent preparation assembly, and

moving fluid within the reaction chamber through the vent path while maintaining the solution and reagent within the reaction chamber.

30. The method of claim 29, wherein depressing the piston includes moving fluid within the reaction chamber through the vent path as solution moves into the reaction chamber.