Stryker Instrument's Interventional Pain Division approached Design Concepts to design a disposable, sterile, digital discography tool – a minimally invasive diagnostic device to assess the extent of intervertebral disc damage and determine the source of back pain.
Design Concept's team of electrical and mechanical engineers created solutions for the development of the Discmonitor™, which is used to inject fluid into the disc during discography procedures. The device is able to accurately measure the pressure of the fluid injected into the disc up to 120 psi. In addition to measuring pressure, this device is the first in its field to also measure the volume injected. The screw driven syringe of the Discmonitor™ provides the physician with tactile feedback and fine control. The device allows physicians the ability to test multiple discs in one procedure.
All of the information gathered during a procedure is automatically displayed on an LCD screen and stored, giving the physician immediate feedback of essential information. Data for each disc (up to 6 discs) can be recalled on the LCD screen by the physician during the procedure. The physician may print a comprehensive report using a wireless infrared communication system between the unit and the printer. The tool gives extensive, objective information that improves the accuracy of the diagnosis and helps the physician choose the most effective treatment. Extensive FMEA documentation and tolerance stack-ups conducted by Design Concepts' engineers provided essential information for the FDA application process.
The Stryker DiscmonitorTM Discography device received FDA approval and is on the market today.