A novel clip-on device for electromagnetic tracking in endobronchial ultrasound bronchoscopy.

The established method for assessment of mediastinal and hilar lymph nodes is endobronchial ultrasound bronchoscopy (EBUS) with needle aspirations. Previously, we presented an electromagnetic navigation platform for this purpose. There were several issues with the permanent electromagnetic tracking (EMT) sensor attachment on the tip of the experimental EBUS bronchoscope. The purpose was to develop a device for on-site attachment of the EMT sensor.A clip-on EMT sensor attachment device was 3D-printed in Ultem™ and attached to an EBUS bronchoscope. A specially designed ultrasound probe calibration adapter was developed for on-site and quick probe calibration. Navigation accuracy was studied using a wire cross water phantom and clinical feasibility was tested in a healthy volunteer.The device attached to the EBUS bronchoscope increased its diameter from 6.9 mm to 9.5 mm. Average preclinical navigation accuracy was 3.9 mm after adapter calibration. The maneuvering of the bronchoscope examining a healthy volunteer was adequate without harming the respiratory epithelium, and the device stayed firmly attached.Development, calibration and testing of a clip-on EMT sensor attachment device for EBUS bronchoscopy was successfully demonstrated. Acceptable accuracy results were obtained, and the device is ready to be tested in patient studies.