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Publication Number
US-10668473-B2
Publication Date
2020-06-02
Expiration Date
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.
Core Innovation
The invention relates to an all-in-one reagent preparation assembly for reconstituting and withdrawing a reagent. The assembly includes a sealed body with a reaction chamber configured to contain an unreconstituted reagent, including a lyophilized or dry reagent, and an access port configured to receive an instrument. The access port includes sealing features to limit moisture exposure and maintain seal integrity.
A movable reconstitution assembly includes a plunger, a syringe having a solution reservoir, and a piston. Depressing the plunger moves the syringe seal from a piercing position into a solution moving position, where the syringe seal is pierced so that solution is fluidly communicated from the syringe into the reaction chamber. During this transition, the plunger is automatically disengaged from the syringe and automatically engaged with a piston, so that the piston-driven movement pushes solution into the reaction chamber.
The reaction chamber includes a well structure configured to localize the reconstituted reagent mixture beneath the access port. The solution is mixed with the unreconstituted reagent within the reaction chamber to form a reagent mixture. In an alternative configuration, reagent is coupled to a chamber surface and solution delivery occurs via a solution channel into a trough or well to pool and allow aliquot access.
Claims Coverage
The independent claim covers a method of reconstituting and withdrawing a reagent using a plunger-driven, seal-piercing syringe-to-reaction-chamber transfer, with automatic disengagement and piston engagement for moving the solution, followed by mixing to form a reagent mixture. The inventive features are implemented through one main reconstitution-with-withdrawal sequence and are further refined in dependent claims by specific mechanical engagement/disengagement features, solution-transfer structure, mixing location, and drawing the mixture through an access port.
Plunger seal piercing into a reaction chamber
Depressing a plunger of a reconstitution assembly from an initial position to a piercing position engaged with a syringe, wherein depressing the plunger pierces a syringe seal that closes a reaction chamber.
Syringe port and access port with isolation by syringe seal
A body coupled with the reaction chamber includes a syringe passage extending toward the reaction chamber and a syringe port, wherein the syringe seal isolates the syringe passage from the reaction chamber, and includes an access port extending toward the reaction chamber and configured to receive an instrument.
Automatic plunger disengagement and piston engagement for solution movement
Depressing the plunger from the piercing position to a solution moving position moves a solution from the syringe into the reaction chamber, wherein depressing the plunger from the piercing position to the solution moving position includes automatically disengaging the plunger from the syringe, automatically engaging the plunger with a piston, and moving the solution from the syringe to the reaction chamber according to movement of the plunger engaged with the piston.
Mixing solution with unreconstituted reagent to form a reagent mixture
Mixing the solution with an unreconstituted reagent within the reaction chamber to form a reagent mixture.
Automatic camming disengagement of a deflectable tongue
Automatically disengaging a deflectable tongue that engages a syringe plunger by deflecting the tongue using a camming surface.
Automatic engagement of plunger with a piston after disengagement
Automatically engaging the plunger with a piston by engaging a plunger post with the piston after the plunger has been disengaged from a syringe.
Solution transfer using syringe orifice and solution reservoir across positions
Moving the syringe from a piercing position to a solution moving position such that a syringe orifice connected to a solution reservoir directs the solution into a reaction chamber.
Tapered well mixing beneath the access port
Performing mixing of the solution with an unreconstituted reagent in a tapered well beneath an access port configured to receive an instrument.
Drawing the reagent mixture into an instrument through the access port
Drawing at least a portion of a reagent mixture into an instrument located in the reaction chamber through an access port.
The claim set is centered on piercing a syringe seal that closes a reaction chamber to transfer solution from a syringe into the reaction chamber while automatically disengaging and engaging the plunger with a piston. The transferred solution is mixed with an unreconstituted reagent to form a reagent mixture, and the mixture is withdrawn via the access port, with dependent claims refining mechanical engagement/disengagement, solution-transfer structure, mixing in a tapered well, and withdrawing the mixture into an instrument.
Stated Advantages
Accurate concentration.
Minimized user variability.
Reduced contamination and moisture exposure.
Ability to produce multiple aliquots without retaining large volumes.
Documented Applications
Diagnostic or therapeutic procedures.
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