Platform Technology for Multiple IGT applications

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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

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Disclosure
Bob Galloway is the founder of , and retains an
equity position in, Pathfinder Therapeutics Inc,
of Nashville, TN
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Technology-Guided Therapy
Mechanical Data
Thermal Data
Optical Data
Neuroprosthesis
Radiation Therapy
Surgical Resection
Ablation Tech niques
Ortho pedics
External Beam Radiation
Intra- Operative Imaging
Image-Guided Surgery
Preoperative Images
Image-Guided Procedures
Image-Guided Interventions
Tissue Models
Gene Therapy
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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.
• 1940s1950s Leksell, Riechert-Mundinger,
  Talairach, Cooper...

TGT
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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

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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

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Software Design

• Fundamental concepts
• Basic requirements
• Task list
• Methodology
• Workflow assessment
• Information and data flow
• Task Organization
• Software Organization

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Fundamental Concepts for TGT Software

• In designing image-guided therapeutic devices, we
  accept responsibility for the patients 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
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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
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Task List

• Localizer
• Display
• Graphics
• I/O
• Registration
• Correction

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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

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Software Organization
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New Software Design
Display
Localizer
IO
Video
Optotrak 3020
A-Mode US
Optotrak Certus
Tomogram
Polaris
LRS
Polaris Vicra
Rotational
Polhemus
Aurora
Biomechanical
2-D Images
Optical Biopsy
Claron
da Vinci
ORION
Graphic
Registration
Correction
Render
Deformation
Quaternion
Salient Feature
Biopsy
Functional
SVD
Patch
Preop Plan
HTM
ICP
Transparency
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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

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Applications of TGT

• Kidney Surgery
• Lung Therapy
• Tumor resection/ablation/brachytherapy
• Prostate Therapy
• Open or robotic surgery
• Brachytherapy
• Direct injection Chemotherapy/ Gene Therapy

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Image-Guided Neurosurgery
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Image-Guided Liver Surgery (IGLS)
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Spinal Surgery
Image
Guide
Confirm
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Applications of TGT
Colorectal Cancer Staging and Surgery

• One of the most prevalent cancers in the US
• Visualization of the layered structure of the
  rectum is important for staging and therapy

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Cochlear Implantation

• Cochlear Implants

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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 lt 10 ms
• Surface based registration (liver, 20,000 points)
  35 seconds

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Orion Code Base drives (1)

• Intracranial Neurosurgery
• Tumor resection
• Implantation of Neuroprostheses
• Functionally Guided Neurosurgery
• Spinal Surgery
• Liver Surgery
• Direct injection Chemotherapy

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Orion Code Base drives (2)

• Colorectal Cancer Staging and Surgery
• Ophthalmologic Surgery
• Cochlear Implants
• Robotic Image-Guided Surgery
• Direct Injection Gene Therapy

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Orion Licensing

• Base program DLLs available for research
  license from Vanderbilt University
• Custom DLL development is available by contract
  to Vanderbilt
• ORION with FDA VV process available from
  Pathfinder Therapeutics Inc

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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

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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