A "Smart" Force-Limiting Instrument for Microsurgery: Laboratory and In Vivo Validation.

Residents are required to learn a multitude of skills during their microsurgical training. One such skill is the judicious application of force when handling delicate tissue. An instrument has been developed that indicates to the surgeon when a force threshold has been exceeded by providing vibrotactile feedback. The objective of this study was to validate the use of this "smart" force-limiting instrument for microsurgery. A laboratory and an in vivo experiment were performed to evaluate the force-limiting instrument. In the laboratory experiment, twelve novice surgeons were randomly allocated to use either the force-limiting instrument or a standard instrument. Surgeons were then asked to perform microsurgical dissection in a model. In the in vivo experiment, an intermediate surgeon performed microsurgical dissection in a stepwise fashion, alternating every 30 seconds between use of the force-limiting instrument and a standard instrument. The primary outcomes were the forces exerted and the OSATS scores. In the laboratory experiment, the maximal forces exerted by novices using the force-limiting instrument were significantly less than using a standard instrument, and were comparable to intermediate and expert surgeons (0.637N versus 4.576N; p = 0.007). In the in vivo experiment, the maximal forces exerted with the force-limiting instrument were also significantly less than with a standard instrument (0.441N versus 0.742N; p <0.001). Notably, use of the force-limiting instrument did not significantly impede the surgical workflow as measured by the OSATS score (p >0.1). In conclusion, the development and use of this force-limiting instrument in a clinical setting may improve patient safety.