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

Task List

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

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

Software Organization

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

Image-Guided Neurosurgery

Image-Guided Liver Surgery (IGLS)

Spinal SurgeryImage Guide Confirm

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

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

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