Two-Stage Reconstituting Injector for Particulate Medicament Delivery
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Solution Overview
Problem
Existing injection devices face challenges with insoluble or particulate drug constituents in liquid medicament preparations that can clog needles, especially when self-administered by non-professional caregivers, as these particles separate during storage and require adequate resuspension for proper drug delivery.
Innovation Solution
An injector design that includes a container with two chambers, a transfer mechanism to combine injectable components before injection, and a firing mechanism to deliver the medicament as a jet through a needle or nozzle, ensuring reliable reconstitution and delivery of the medicament just prior to injection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If liquid medicament preparations containing insoluble particles are stored, then the particles separate and settle, but this increases the risk of needle clogging during injection
Solution Approach 1:
The injection device divides the medicament preparation into two separate chambers: a first chamber containing the liquid vehicle and a second chamber containing the particulate drug constituents. This segmentation prevents the particles from settling and clogging the needle during storage, while allowing reconstitution to occur just before injection through the transfer mechanism.
Solution Approach 2:
The device performs preliminary reconstitution by transferring the liquid vehicle from the first chamber to the second chamber containing the particles, creating a reconstituted medicament solution in the second chamber before injection. This ensures the particles are properly suspended and the needle is cleared of any settled material prior to delivery.
2Ease of operation
If non-professional caregivers self-administer injections with settled particulate material, then handling becomes inadequate, but professional handling ensures proper delivery
Solution Approach 1:
The injection device is designed as a self-contained system that automatically performs the reconstitution process when the user activates the transfer mechanism. Non-professional caregivers simply need to operate the pre-programmed device, which automatically transfers the liquid to the particulate chamber and prepares the injection, eliminating the need for manual resuspension or needle clearing techniques.
Solution Approach 2:
The device incorporates a control system that monitors and controls the transfer mechanism and firing sequence. The control mechanism ensures that the liquid is transferred to the second chamber, the mixture is properly prepared, and only then is the injection fired, providing automated feedback control that ensures proper drug delivery even when used by non-professionals.
3Reliability
If a two-stage reconstitution process is implemented, then needle clogging is reduced, but device complexity increases
Solution Approach 1:
The device merges multiple functions into integrated components: the container houses both chambers, the transfer mechanism combines mixing and reconstitution functions, and the firing mechanism integrates the injection delivery system. This consolidation reduces the number of separate components and simplifies the overall device structure despite the two-stage process.
Solution Approach 2:
The transfer mechanism serves multiple functions: it transfers the liquid vehicle from the first chamber to the second chamber, simultaneously mixes the particulate material with the liquid, and prepares the reconstituted medicament for injection. This multi-functionality reduces the need for separate mechanisms for each step, thereby reducing overall device complexity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Facilitates easy and effective delivery of medicaments by ensuring the reconstitution of particulate drug constituents, reducing the risk of clogged needles and improving handling reliability for self-administration by non-professional caregivers.
Implementation Method 1
a firing mechanism operable by the user for firing the fluid from the second chamber through the injection conduit in a second stage of operation
Data Source
AI summary
An injector (10) for injecting a medicament into a patient. The injector includes a container (18) defining a first chamber (22), which contains a fluid therein, and a second chamber (23). The injector also includes an injection conduit (126) configured for directing the fluid fired from the container into the patient. A transfer mechanism is operable by a user to transfer the fluid from the first chamber to the second chamber in a first stage of operation, and a firing mechanism is operable by the user for firing the fluid from the second chamber through the injection conduit in a second stage of operation. An energy source (62) is in powering association with the firing mechanism to drive firing mechanism in the first and second stages.