Portable drug mixing and delivery device and associated methods
Inventors
Buchine, Brent • Standley, Adam R. • Stepanian, Christopher J. • Nellaiappan, Kaliappanadar • Constantineau, Cole • Bruehwiler, Michel • Chagnon, Jeffrey Thomas • Brik, Robert
Assignees
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Abstract
A portable dual chamber auto-injector configured to store a dry opioid antagonist medicament separately from a liquid component, wherein a user actuated mixing system comprising a movable component to create a fluidic pathway between the first and second chambers and release a portion of energy from a pre-stored energy to drive a displacement mechanism into the first chamber and displace the liquid component into the second chamber and solubilize the opioid antagonist. A needle assembly in fluid communication with the second chamber can be used to transfer the solubilized opioid antagonist.
Core Innovation
The invention relates to a dual chamber drug mixing system and a dual chamber medication mixing device in which a first chamber and a second chamber are disposed within a housing, with the first chamber axially aligned with the second chamber. The first chamber and the second chamber are not in communication during a closed state, and the first chamber has an outlet offset from a central longitudinal axis while the second chamber has an inlet. First and second medicament components are provided in the first and second chambers, respectively, and the second medicament component includes an opioid antagonist compound.
A user operable mixing system and a valve are used so that, when activated, fluidic communication occurs between the outlet of the first chamber and the inlet of the second chamber, and a first displacement mechanism drives the first medicament component into the second chamber. This mixing causes the first medicament component and the second medicament component to mix, resulting in a mixed medicament compound. The valve is configured to open or close a fluidic pathway between the first chamber and the second chamber.
The device architecture further enables independent motion of the first chamber and the second chamber within the housing, with the first chamber having a first sidewall and the second chamber having a second sidewall separate and distinct from the first sidewall. In the medication mixing device, the user operable mixing system includes a fluidic channel that rotates about the central longitudinal axis to selectively align with the valve assembly. The opioid antagonist compound is provided in an amount of 1 mg/kg to 25 mg/kg based on a recipient's weight, and the opioid antagonist compound is naltrexone, with a bump switch activating a second actuation mechanism to drive the mixed medicament compound through a delivery assembly.
Claims Coverage
Independent inventive coverage is provided by two independent claims. The main inventive features relate to a dual chamber mixing arrangement with a valve and user operable mixing system to create fluid communication from a closed state, dose-defined naltrexone in the second chamber, and displacement-driven mixing followed by bump switch-actuated delivery.
Dual chamber mixing system with selectively opened fluidic pathway
A dual chamber drug mixing system with a housing; a first chamber and a second chamber disposed within the housing, not communicating during a closed state; a valve disposed between the outlet of the first chamber and the inlet of the second chamber configured to open or close a fluidic pathway; and a user operable mixing system that, when activated, causes fluidic communication between the outlet of the first chamber and the inlet of the second chamber.
Displacement-driven mixing of separate medicament components
A user operable mixing system having a first displacement mechanism, wherein activation causes the first displacement mechanism within the first chamber to drive the first medicament component into the second chamber so that fluid communication occurs between the first chamber outlet and the second chamber inlet.
Naltrexone-containing second medicament with recipient-weight amount
The second medicament component includes an opioid antagonist compound in an amount of 1 mg/kg to 25 mg/kg based on a recipient's weight, with the opioid antagonist compound specified as naltrexone.
Independent chamber movement with separate sidewalls
The first chamber and the second chamber are configured to move within the housing independently with respect to each other, wherein the first chamber has a first sidewall and the second chamber has a second sidewall separate and distinct from the first sidewall.
Rotating fluidic channel aligned with valve assembly
A dual chamber medication mixing device where the user operable mixing system having a fluidic channel is configured to rotate about the central longitudinal axis to selectively align the fluidic channel with the valve assembly.
Bump switch-actuated delivery of mixed medicament compound
A bump switch configured to activate a second actuation mechanism to drive the mixed medicament compound through a delivery assembly.
Across the independent claims, the inventive coverage centers on a dual chamber arrangement in a housing with a selectively opened valve to establish fluid communication from a closed state, a user operable mixing system with a displacement mechanism to drive the first medicament component into a second chamber, and a dose-defined naltrexone-containing second medicament component, followed by bump switch-actuated delivery through a delivery assembly. The independent claims further specify independent chamber motion and, in the device claim, a rotating fluidic channel aligned with the valve assembly.
Stated Advantages
Increased stability/shelf life and retention of potency/chiral purity after temperature exposure.
Documented Applications
Autoinjector context with a dual-chamber drug mixing and delivery arrangement for an opioid-antagonist-containing mixed medicament compound.
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