platform technology for multiple igt applications robert l. galloway jr., phd professor of...
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Platform Technology for Multiple IGT applications
Robert L. Galloway Jr., PhDProfessor of Biomedical Engineering
Professor of Neurosurgery Professor of Surgery
Director, Center for Technology-Guided TherapyVanderbilt University
Disclosure
Bob Galloway is the founder of , and retains an equity position in, Pathfinder Therapeutics Inc, of
Nashville, TN
Surgical Resection
Preoperative Images
Image-Guided Surgery
Image-Guided Procedures
Neuroprosthesis
Orthopedics
External Beam
Radiation
Image-Guided Interventions
AblationTechniques
Radiation Therapy
Mechanical Data Thermal Data Optical Data
Tissue Models Gene Therapy
Intra-OperativeImaging
Technology-Guided Therapy
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...
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
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
Software Design
• Fundamental concepts• Basic requirements• Task list• Methodology• Workflow assessment
– Information and data flow– Task Organization
• Software Organization
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
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
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
New Software Design
Video
Tomogram
Rotational
2-D Images
DisplayOptotrak 3020
Polaris
Polhemus Aurora
Localizer
Render
Biopsy
Preop Plan
Transparency
Graphic
A-Mode US
LRS
Biomechanical
Optical Biopsy
IO
Quaternion
SVD
HTM ICP
RegistrationDeformation
Functional
Correction
ORION
Optotrak Certus
Polaris Vicra
Claron da Vinci
Salient Feature
Patch
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
Applications of TGT• Kidney Surgery• Lung Therapy
– Tumor resection/ablation/brachytherapy
• Prostate Therapy– Open or robotic surgery– Brachytherapy
• Direct injection Chemotherapy/ Gene Therapy
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
Cochlear Implantation• Cochlear Implants
RoundWindow
FACIAL NERVE
CochlearPromontory
MiddleEar
Bones
#1#2
#3
HorizontalSemicircular
Canal
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
Orion Code Base drives: (1)
• Intracranial Neurosurgery– Tumor resection– Implantation of Neuroprostheses– Functionally Guided Neurosurgery
• Spinal Surgery• Liver Surgery• Direct injection Chemotherapy
Orion Code Base drives: (2)
• Colorectal Cancer Staging and Surgery
• Ophthalmologic Surgery• Cochlear Implants • Robotic Image-Guided Surgery• Direct Injection Gene Therapy
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
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