Implantation Software (Milestone Sample Clauses

Implantation Software (Milestone. 1) A software tool is under development that will break the implantation procedure into the following clearly defined stages : (1) preparation and burrhole localization (2) trajectory guide alignment (3) mandrel insertion and (if necessary) revision (4) completion and report generation. The software tool will be run on an independent workstation with a direct network connection to the MR acquisition console. This approach has the advantage of being independent to the MR system manufacturer and specific MR software release. The objective of the software is to intuitively lead the clinician through the implantation procedure, present optimal visualization of the procedure, and to provide guidance with regard to the required geometric properties of MR acquisitions. Initial software evaluations will be performed with specific SW components, with full evaluation subsequently performed in Section 3.1.4. There are several novel components that must be validated, including automated AC, PC and mid-sagittal plan detection, alignment indicator projection and X-Y stage offset settings. Automated AC, PC and mid-sagittal plan detection will be performed on pre-operative data obtained in 10 DBS patients. Two trained neurosurgeons (PS, PL) will independently identify the spatial coordinates of AC and PC and the angulation of the mid-sagittal plane. Correlation within and between the neurosurgical practitioners and the SW will be established. Next, projection of the alignment indicator will be tested in a saline filled phantom. The trajectory guide will be positioned in the same 25 orientations indicated in Section 3.1.2, MR scans will be acquired and automatic projections created. A rigid ceramic mandrel will then be inserted through the alignment indicator to provide truth, and the difference between the mandrel position and ray prediction 8 cm (~ target depth) below the pivot point quantified. The results will be interrogated for systematic errors and mean relative errors <0.5mm will be sought. Finally, the X-Y stage offset will be tested by deliberately misaligning the trajectory guide to be 1-3 mm from the intended target. The desired offset vector will be specified and the necessary translation of the X-Y stage calculated based on the relative orientation and angulation of the trajectory guide to the scan plane in which the target was identified. The mandrel will then be withdrawn, the X-Y stage translated and the mandrel re-inserted. The magnitude and direction of ...
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