Shape accuracy of fiber optic sensing for medical devices characterized in bench experiments.

Purpose: Fiber Optic RealShape (FORS) is a new technology that visualizes the full three-dimensional shape of medical devices, such as catheters and guidewires, using an optical fiber embedded in the device. This three-dimensional shape provides guidance to clinicians during minimally invasive procedures, and enables intuitive navigation. The objective of this paper is to assess the accuracy of the FORS technology, as implemented in the current state-of-the-art Philips FORS system. The FORS system provides the shape of the entire device, including tip location and orientation. We consider all three aspects.

Methods: In bench experiments, we determined the accuracy of the location and orientation of the tip by displacing and rotating the fiber end, while allowing the rest of the fiber to change shape freely. To test the accuracy of the full shape, we have placed the fiber in a groove, which was accurately machined in a thick, stiff metal "path plate." We then compared the reconstructed shape with the known shape of the groove.

Results: The tip location is found with submillimeter accuracy, and the orientation is sensed with milliradian accuracy. The shape of a fiber in the path plate faithfully follows the known shape of the groove, with typical deviation less than 0.5 mm in the plane of the plate. Out of plane accuracy, perhaps slightly less relevant clinically, is more challenging, due to the influence of twist; yet even out of the plane, the deviation is only submillimeter.

Conclusion: The technology achieves submillimeter precision and provides full three-dimensional shape, surpassing the reported precision of other navigation and tracking technologies, and therefore may potentially alleviate the need for fluoroscopy.