1. Platform Technology for Multiple IGT applications Robert L. Galloway Jr., PhD Professor of Biomedical Engineering Professor of Neurosurgery Professor of Surgery Director, Center for Technology-Guided Therapy Vanderbilt University

2. Disclosure Bob Galloway is the founder of, and retains an equity position in, Pathfinder Therapeutics Inc, of Nashville, TN

3. Surgical Resection Preoperative Images Image-Guided Surgery Image-Guided Procedures Neuroprosthesis Ortho pedics External Beam Radiation Image-Guided Interventions Ablation Tech niques Radiation Therapy Mechanical DataThermal DataOptical Data Tissue ModelsGene Therapy Intra- Operative Imaging Technology-Guided Therapy

4. TGT History of Image-Guided Therapy 1896 J.H. Clayton. X-Ray use in surgery 1904 Horsley and Clarke. Stereotactic frame 1946 Spiegel and Wycis. Stereotactic frame using xrays. 1940’s~1950s: Leksell, Riechert- Mundinger, Talairach, Cooper...

5. Technology-Guided Therapy Timeline 1986 –Roberts et al. A frameless stereotaxic integration of computerized tomographic imaging and the operating microscope, J. Neurosurg, 65, 545, 1986. 1987 – “A three dimensional guidance system for stereotactic neurosurgery”. Proposal to the Whitaker Foundation RL Galloway PI –Watanabe et al. “Three ‑ dimensional digitizer (neuronavigator): new equipment for computed tomography ‑ guided stereotaxic surgery” Surg ‑ Neurol, 27, 1987

6. Technology-Guided Therapy Timeline 1997 (Vanderbilt) –Discussions begin about applying IIGS techniques to other organs –Discussions begin about software redesign (Orion) Abstract the TGT process Software Architecture –Speed of Performance –Avoidance of software bloat –Minimize the effect of the Law of Unintended Consequences

7. Software Design Fundamental concepts Basic requirements Task list Methodology Workflow assessment –Information and data flow –Task Organization Software Organization

8. Fundamental Concepts for TGT Software In designing image-guided therapeutic devices, we accept responsibility for the patient’s care. –The responsibility must be ours. Mission critical engineering is evaluated not on its average performance but on its worst case performance. –Nobody dies in image space TGT

9. Basic Requirements Need images and knowledge of both the information they convey and their spatial characteristics. Need a three (or six) dimensional tracking system. Need a methodology for the visualization of path, structures and target. Need a method of registration from physical space to image spaces Correction for perioperative and intraoperative changes TGT

10. Task List Localizer Display Graphics I/O Registration Correction

11. Methodology Open Architecture with defined interfaces DLL design for run time selection of function –Reduces software bloat –Allows rapid debug and leak detection No communication between functions with different DLLs –Allows data encapsulization

12. Software Organization

13. New Software Design Video Tomogram Rotational 2-D Images Display Optotrak 3020 Polaris PolhemusAurora Localizer Render Biopsy Preop Plan Transparency Graphic A-Mode US LRS Biomechanical Optical Biopsy IO Quaternion SVD HTMICP Registration Deformation Functional Correction ORION Optotrak Certus Polaris Vicra Claronda Vinci Salient Feature Patch

14. Applications of TGT Intracranial Neurosurgery –Tumor resection –Implantation of Neuroprostheses –Functionally Guided Neurosurgery Spinal Surgery Liver Surgery Colorectal Cancer Staging and Surgery Ophthalmologic Surgery Cochlear Implants

15. Applications of TGT Kidney Surgery Lung Therapy –Tumor resection/ablation/brachytherapy Prostate Therapy –Open or robotic surgery –Brachytherapy Direct injection Chemotherapy/ Gene Therapy

16. Image-Guided Neurosurgery

17. Image-Guided Liver Surgery (IGLS)

18. Spinal Surgery ImageGuideConfirm

19. Applications of TGT One of the most prevalent cancers in the US Visualization of the layered structure of the rectum is important for staging and therapy Colorectal Cancer Staging and Surgery

20. Cochlear Implantation Cochlear Implants Round Window FACIAL NERVE Cochlear Promontory Middle Ear Bones #1 #2 #3 Horizontal Semicircular Canal

21. ORION Performance System boot time in the OR: 15 seconds Number of image types: Simultaneous display: 4 Number of image types: OR selectable: 64 Image update (unsynched) 4 512x512 images at 63 Hz. Point based registration: < 10 ms Surface based registration (liver, 20,000 points) 35 seconds

22. Orion Code Base drives: (1) Intracranial Neurosurgery –Tumor resection –Implantation of Neuroprostheses –Functionally Guided Neurosurgery Spinal Surgery Liver Surgery Direct injection Chemotherapy

23. Orion Code Base drives: (2) Colorectal Cancer Staging and Surgery Ophthalmologic Surgery Cochlear Implants Robotic Image-Guided Surgery Direct Injection Gene Therapy

24. Orion Licensing Base program + DLL’s available for research license from Vanderbilt University Custom DLL development is available by contract to Vanderbilt ORION with FDA V&V process available from Pathfinder Therapeutics Inc

25. Three important challenges for the engineering of IGT systems Validation –Agreed upon accuracy metrics –Phantom design –Human use Robustness –Sensitivity to variability Vertical Integration –Will the solution work for all patients

26. Help address these challenges Image-Guidance is the modifier, not the driving force. Involve the people doing the therapy at every step: –Writing proposals –Reviewing proposals –Planning the protocols –Using the systems and providing feedback IGS/IGT/IGP/TGT needs its own study section