To successfully simplify the current procedure, the Auto-Injector must be a portable device that eliminates the need for a second person, maintains a similar procedure workflow, and provides some form of haptic feedback to the user that indicates injection pressure. A WOW solution would be a device that meets all the objectives just listed, but also replicates the injection force with 1:1 tactile force feedback and completely maintains the workflow of the current procedure.
The WOW solution was ambitiously pursued and nearly achieved with a hydraulic haptic feedback system mounted to a linear lead screw syringe actuator. The four main components listed in the diagram below form a loop that attempts to replace the second person with an incremental injection approach. A small injection controller houses a shortened 20cc syringe (at just 40mm in length). The shortened syringe is filled with water and connected with tubing up to a 50cc syringe mounted to the linear actuator, thus forming a hydraulic system. The displacement of the controller syringe plunger is translated proportionally to a separate syringe fixed to the front of the linear actuator. The medication line runs from the medication syringe through a pinch valve until it reaches a nerve block needle mounted to the front of the controller syringe, which completes the loop of the system. The concept is that the hydraulics translate the force required for each injection or aspiration stroke to the user in real time. After each injection stroke of the controller plunger, a combination of sensor inputs trigger the engagement of a pinch valve. The simultaneous forward displacement of the drive plate resets the hydraulics to the original position.
Auto-injector System Diagram. Created with BioRender.com
Flowchart of Component Workflow. Created with BioRender.com
Final Hardware Prototype
The controller places the needle 50% closer to the doctor’s point of contact when compared to using a standard 20cc syringe to inject directly in a similar fashion.
In the figure to the right, the human force difference perception threshold is plotted, which is 7% of forces in the 2.5 - 10 N range. The mean difference from 1:1 force replication was 1.2 N.
Force Replication Testing Results
Gravimetric Testing Results
According to gravimetric testing results shown to the left, the system allows for an incremental injection volume of 1.05 +/- 0.03 cc with each full stroke of the injection controller. The finger loop of the controller syringe allows for an aspiration volume of 0.51 +/- 0.02 cc. Both volumes listed have a 95% confidence interval.
The figure to the left shows force data for different syringe combinations. The 20-50cc hydraulic syringe combination was our best commercially available option and is used by the current prototype.
Force Testing Results
Hydraulics Testing Results
The plot to the right shows our final hydraulic syringe combination plotted with the control data obtained with a force sensor mounted to the linear actuator of the machine.
The syringe controller provides a mean of 1.3:1 proportional force feedback with a mean difference from 1:1 force replication of 1.3 N in the opening stages of injection.
The final design iteration was a successful proof-of-concept prototype that reduces the procedure to a one-person operation, maintains a similar workflow, and provides tactile haptic feedback. However, this prototype must be improved in future iterations to inject at least 5 cc of medication per injection stroke. Furthermore, the hydraulics of future iterations must be tuned to provide truly 1:1 tactile haptic feedback during the initial stages of injection. Finally, sterility issues must also be addressed. Our written report provides detailed recommendations for solving these issues and paves the way for future improvements that will hopefully lead to a successful end product.