Work/Projects/StrykerDiscmonitorTM
Work/Description
Abstract/ Create a minimally invasive diagnostic device to assess the extent of intervertebral disc damage and determine the source of back pain. Challenge/ Stryker Instrument's Interventional Pain Division approached Design Concepts to design a disposable, sterile, digital discography tool. The tool needed to be able to measure pressure, and volume of the diagnostic fluid injected into the patient's discs and allow the physician the ability to test multiple discs in one procedure. Solution/ Design Concept's team of electrical and mechanical engineers developed a device able to accurately measure pressure of the injected fluid up to 120 psi. The screw driven syringe provides the physician with tactile feedback and fine control. In addition to pressure, this device is the first in its field to also measure the volume injected. 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. Extensive FMEA documentation and tolerance stack-ups conducted by Design Concepts engineers provided essential information for the FDA application process. Results/ The tool gives extensive, objective information that improves the accuracy of the diagnosis. The Stryker DiscmonitorTM Discography Device received FDA approval and is on the market today.