Reagent preparation and dispensing device

• US 9,889,442 B2
• Filed: 07/15/2014
• Issued: 02/13/2018
• Est. Priority Date: 11/18/2010
• Status: Active Grant

• Current Assignee: Biolyph, LLC
• Original Assignee: Biolyph, LLC
• Inventors: Pearcy, Timothy, Skakoon, James G.
• Primary Examiner(s): ARNETT, NICOLAS ALLEN
• Application Number:
  US14/331,431
• Publication Number:
  US 20140322102A1
• Time in Patent Office: 1,309 Days
• Field of Search: 141 2, 141 4, 141 21, 141 25- 27, 141392, 422501-514
• CPC Class Codes: A61M 2005/1787 Syringes for sequential delivery of fluids, e.g. first medicament and then flushing liquid
• CPC Class Codes: A61M 2005/3104 Caps for syringes without needle
• CPC Class Codes: A61M 2005/312 comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting
• CPC Class Codes: A61M 2005/3123 having air entrapping or venting means, e.g. purging channels in pistons
• CPC Class Codes: A61M 5/284 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/285 with sealing means to be broken or opened
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: B01L 3/0206 of the plunger pump type
• 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

Abstract

A reagent preparation and dispensing device includes a body having a reaction chamber for a reagent and a solution reservoir for a solution. The solution reservoir is isolated from the reaction chamber. A plunger is movably coupled with the body. Movement of the plunger from a starting position to a seated position pushes the solution into the reaction chamber. A dispensing path extends from the reaction chamber out of the body. The dispensing path is configured to dispense a reagent mixture formed from the solution and the reagent. A vent path extends from the reaction chamber, the vent path vents reaction chamber gas displaced by the addition of the solution to the reaction chamber throughout movement of the plunger from the starting position to the seated position.

Claims

1. An apparatus comprising:

a body including;

a reaction chamber configured to include a reagent, and

a solution reservoir configured to include a solution, the solution reservoir is isolated from the reaction chamber;

a dispensing path extending from the reaction chamber;

an activator movably coupled with the body, the activator includes a mixing configuration and a dispensing configuration, wherein;

in the mixing configuration, the activator is movable to mix the solution with the reagent in the reaction chamber, and

in the dispensing configuration the activator is movable to dispense the solution through the dispensing path; and

a vent path different from the dispensing path extending from a reaction chamber, wherein the vent path vents the reaction chamber gas displaced by the addition of the solution to the reaction chamber throughout movement of the activator from the mixing configuration to the dispensing configuration.

2. The apparatus of claim 1, wherein the dispensing path is configured to be selectably closed.

3. The apparatus of claim 1, wherein the vent path includes a semi-permeable medium that prevents passage of the reagent mixture.

4. The apparatus of claim 1, further comprising a plunger movably coupled with the activator, wherein the plunger is movable to mix the solution with the reagent in the reaction chamber.

5. The apparatus of claim 1, further comprising a barrel movably coupled with the body, and the plunger is movably coupled with the barrel.

6. The apparatus of claim 5, wherein the vent path is isolated from the solution reservoir and in communication with the reaction chamber through a reaction chamber vent.

7. The apparatus of claim 5, wherein the vent path extends through the barrel and along the plunger.

8. The apparatus of claim 7, wherein the vent path extends along a barrel exterior through a first vent portion, and the vent path extends along a barrel interior through a second vent portion.

9. An apparatus comprising:

a body including;

a reaction chamber configured to include a reagent, and

a solution reservoir configured to include a solution, the solution reservoir is isolated from the reaction chamber;

a plunger movably coupled between a starting position and a seated position, wherein;

in the starting position, the solution reservoir and the reaction chamber are isolated, and

in the seated position, the plunger is configured to push the solution into the reaction chamber;

a flushing chamber, different from the reaction chamber, including a flushing fluid in communication with the reaction chamber;

a dispensing path extending from the reaction chamber and out of the body, wherein;

in a closed configuration, the dispensing path is sealed, and

in a dispensing configuration, the dispensing path is configured to deliver a reagent mixture formed from the solution and the reagent; and

a flushing path including the flushing chamber at a first end and the reaction chamber at a second end, wherein the flushing fluid is pushed through the flushing path, and the flushing fluid pushes the reagent mixture from the reaction chamber through the dispensing path.

10. The apparatus of claim 9, further comprising a barrel movably coupled with the body, and the plunger is movably coupled with the barrel.

11. The apparatus of claim 10, wherein the barrel includes a storage configuration and a mixing configuration, including:

in the storage configuration, the solution reservoir is isolated from the reaction chamber and the reaction chamber has a first volume, and

in the mixing configuration, the solution reservoir is in communication with the reaction chamber, the reaction chamber has a second volume smaller than the first volume.

12. The apparatus of claim 11, wherein the barrel translates from the storage configuration to the mixing configuration, and in the mixing configuration, the barrel is received within the reaction chamber.

13. The apparatus of claim 9, further comprising a vent path extending from the reaction chamber, the vent path includes open and closed configurations:

in the open configuration, the vent path extend outside of the body, and the vent path vents reaction chamber gas displaced by the addition of the solution to the reaction chamber, and

in the closed configuration, the vent path is closed, and flushing fluid delivered from the flushing chamber dispenses the reagent mixture through the dispensing path.

14. The apparatus of claim 9, wherein the volume of the flushing chamber is greater than the volume of the reaction chamber.

15. A method of making a vented reconstitution assembly comprising:

coupling a solution reservoir with a body, the solution reservoir configured to store a solution;

coupling a reaction chamber with the body, the reaction chamber configured to store a reagent;

forming a dispensing path from the reaction chamber;

forming a vent path from the reaction chamber, the vent path different from the dispensing path; and

movably coupling an activator with the body, the activator movable in mixing and dispensing configurations, wherein;

in the mixing configuration the activator is movable to mix the solution with the reagent in the reaction chamber, and gas within the reaction chamber displaced by the mixing is vented through the vent path, and;

in the dispensing configuration the activator is movable to dispense the solution through the dispensing path.

16. The method of claim 15, wherein movably coupling the activator with the body includes movably coupling a plunger with the body.

17. The method of claim 15, further comprising movably coupling a barrel with the body.

18. The method of claim 17, wherein movably coupling the barrel includes forming the barrel with a storage configuration and a mixing configuration, including:

in the storage configuration, isolating the solution reservoir from the reaction chamber and the reaction chamber to has a first volume, and

in the mixing configuration, forming the solution reservoir to be in communication with the reaction chamber, wherein the reaction chamber has a second volume smaller than the first volume.

19. The method of claim 17, wherein forming the vent path includes forming the vent path between the barrel and the body.

20. The method of claim 17, wherein forming the vent path includes locating the vent path along a barrel exterior through a first vent portion, and locating the vent path along a barrel interior through a second vent portion.

21. The method of claim 15, further comprising forming a closed dispensing tip along the dispensing path, the dispensing tip including a frangible dispensing tip.

22. The method of claim 21, wherein forming the closed dispensing tip includes forming the closed dispensing tip from a first portion of the reaction chamber, and forming the vent path includes extending the vent path from a second portion of the reaction chamber opposed to the first portion.

23. The method of claim 15, further comprising movably coupling a second plunger with the body, and the second plunger is operable to close the vent path and push a flushing fluid through the vent path into the reaction chamber.

24. The method of claim 15, further comprising forming the volume of the flushing chamber, wherein the volume of the flushing chamber is greater volume than the volume of the reaction chamber.

25. A method of reagent preparation and dispensing comprising:

maintaining the orientation of a body;

opening a sealed reaction chamber to a solution reservoir within the body, the reaction chamber containing a reagent;

reconstituting the reagent with a solution retained within the solution reservoir to form a reagent mixture while maintaining the orientation of the body, reconstituting including adding the solution to the reaction chamber;

venting displaced gas from the reaction chamber while maintaining the orientation of the body, the gas is displaced by addition of the solution, the vented gas passing through a vent path extending through the body away from a dispensing tip; and

dispensing a specified amount of the reagent mixture, dispensing including closing the vent path and pushing a flushing fluid through the vent path into the reaction chamber.

26. The method of claim 25, wherein venting displaced gas includes preventing pressurization within the reaction chamber during reconstitution.

27. The method of claim 25, wherein dispensing the specified amount of the reagent mixture includes pressurizing the reaction chamber.

28. The method of claim 25, wherein venting displaced gas includes venting gas through the body in a direction opposed to a direction of dispensing the specified amount of the reagent mixture.

29. The method of claim 25, wherein reconstituting of the reagent is adjacent to the dispensing tip in a first portion of the reaction chamber, and the gas is vented from a second portion of the reaction chamber remote from the first portion.

30. The method of claim 25, wherein dispensing the specified amount of the reagent mixture includes moving a plunger relative to the body, and closing the vent path includes engaging the plunger with a vent wall to seal a flushing chamber formed by the plunger and the vent wall, and pushing the flushing fluid through the vent path includes moving the plunger through the flushing chamber.

31. The method of claim 25, further comprising maintaining the orientation of the body that includes positioning the dispensing tip in a downward direction.

32. The method of claim 25, further comprising flushing the reagent mixture from the reaction chamber, wherein a flushing fluid is pushed from a flushing chamber through a flushing path to flush the reagent mixture from the reaction chamber through the dispensing path.

33. The method of claim 32, further comprising pushing the flushing fluid from the flushing chamber through the flushing path, wherein the volume of the flushing fluid is greater than the volume of the reaction chamber.

34. The method of claim 25, further comprising translating a barrel from a storage configuration to a mixing configuration, wherein:

in the storage configuration, the solution reservoir is isolated from the reaction chamber and the reaction chamber has a first volume, and

in the mixing configuration, the solution reservoir is in communication with the reaction chamber, the reaction chamber has a second volume smaller than the first volume.