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Recent Advances in Medical Robotics Applications, systems and legislation
Tamás Haidegger, Ph.D.
Laboratory of Biomedical Engineering Óbuda University, Antal Bejczy Center for Intelligent Robotics;
Austrian Center for Medical Innovation and Technology (ACMIT)
Seoul National University seminar Seoul, Korea 10.25.2012.
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¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
Budapest University of Technology and Economics (BME)
Third biggest university in Hungary (25,000 students)
8 faculties (all branches of engineering, econom., natural sci.)
Dept. of Control Engineering and IT
Laboratory of Biomedical Engineering
Background 2
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Research background
Cre
dit
: ISS
Inc.
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Junior faculty at BME
• Image-guided skull base drilling
• Electromagnetic tracker assessment
• Surgical skill analysis
• Classical and modern control algorithms for telesurgery
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Background
Óbuda University
John von Neumann Faculty of IT
• Establishing an ERC based on applied research
• Focusing on human-centered studies
• Building on international relations
Antal Bejczy Center for Intelligent Robotics
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Background
Research area manager
• Surgical workflow analysis
• Patient immobilization in radiosurgery
• Laparoscopic skill training • Gynecological robotic brachytherapy
Austrian Center for Medical Innovation and Technology
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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• CEO/CTO Clariton Ltd. - Hand-in-Scan solution
Digital camera
Case
w/ UV.
UV-reflective
antiseptic .
Raw and processed image
Image processing Hardware and software solution combined
Background
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Volunteering
National expert, International Organization for Standardization ISO/TC 184/SC 2/JWG 9 • TC 184: Technical Comm. on Automation Systems & Integration • SC 2: Sub-Committee on Robots and Robotic Devices • JWG 9: Joint Work Group on Standard for Medical Robot Safety • Delegate of the Hungarian Standards Institution (MSZT) • Governor: Gurvinder S. Virk (UK) • National POC: Dr. Seungbin Moon <[email protected]>
IEEE RAS standing committee for standardization • Member of the ORA workgroup—Ontologies for Robots
• Leaders: Craig I. Schlenoff (USA), Edson Prestes (BR)
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¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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Rational for standards
• Following the mainstream development • Facilitating interoperation • Clarifying legal issues • Ensuring user safety
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¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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State of the art in service robotics
Hitachi: EMIEW 2 (Excellent Mobility and Interactive Existence as Workmate 2)
Honda: ASIMO Willow Garage: PR2
Credit: Hitachi, HRP-4C
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Medical robotics
• Visiting robots • Patient carriers • Medical delivery • Rehabilitation robotics • Surgical robotics
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iRobot
Credit: TUG, RP-1
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SoA in rehabilitation robotics
• Rehabilitation devices • Assistive robots • Exoskeletons • Prosthetics • Physiology ther.
Credit: REHAROB cons.
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DARPA/DEKA Arm
Credit: CYBERDYNE Hybrid Assistive Limb
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SoA in surgical application 12
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Market for Computer-Integrated Surgery
• $20 B estimated market for IGS and medical imaging • $20 B estimated market for MIS by 2015 • $5 B estimated for robotic surgery Forecasted to grow $14 B by 2014
Credit: Renishaw
Credit: BrainLAB
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Source: Frost & Sullivan, TMD, Piribo Credit: Gy. Wéber
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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Surgical robotic sales
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• Zeus: 50 (2002, discontinued 2003)
• NeuroMate: ~30 (16 by ISS)
• ROBODOC: ~50 (37 before 2000)
• CASPAR: ~93 (discontinued in 2003)
• MAKO RIO: 113 systems sold (12.2011)
• SpineAssist: 3 in the USA (07.2010)
• Renaissance: 2 in the USA (12.2011.)
• CyberKnife: 220 (2010)
• Hansen Sensei: 130 (Q3 2012)
• da Vinci: ~2400 robots (Q2 2012)
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Current trends in robotic surgery
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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Robotic approaches in CIS
• Human-in-the-loop control
– Leave the mapping to the surgeon
• Registration (image) based – Human oversight
Cre
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Inc.
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• Cooperative control
Cre
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master slave
Intuitive’s da Vinci 17
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Penetration of da Vinci Surgery 18
Intuitive Surgical, 2012
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Da Vinci procedures
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IGS development 20
ROBODOC (Curexo Tech. Co.)
NeuroMate (Renishaw plc.)
MAKOplasty (MAKO)
Magellan (Hansen Medical)
ROSA (MedTech co.)
Credit: MAKO, Rosa, Curexo, Renishaw
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EU FP6–7 projects 21
• ACTIVE – Awake epilepsy surgery with soft robots and
motion compensation – www.active-fp7.eu
• ROBOCAST – Keyhole neurosurgery with
micro-macro robot – www.robocast.eu
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Cooperative control 22
• “Hands-on” technique – The master and the slave devices are identical – Real-time force/torque measurement – Provides haptic feedback
Application examples • Acrobot (Imperial College, London)
– Total knee replacement [Jakopec 2003]
• PathFinder (Armstrong HealthCare, UK) – IG neurosurgery [Finlay 2006]
• Steady-Hand Robot (JHU, USA) – Sinus surgery [Li 2007]
– Skull base surgery [Matinfar 2007]
– Eye robot: retinal vein cannulation [Balicki 2009]
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Neurosurgery robot system JHU neurosurgery robot system 23
CISST ERC Johns Hopkins University
• Cooperative skull base drilling
• NeuroMate robot (5DOF, FDA cleared)
• StealthStation surgical navigator
• 6DOF force sensor (hands-on surgery)
• Surgical bone drill (classical device)
• Slicer 3D (open source)
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Da Vinci competitors—M7
• SRI International, 1998 • Light weight—15 kg • 7 DOF arms • 1:10 scale down • tremor filtering
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Credit: SRI International
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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Raven 25
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• University of Washington • DARPA, OR of the Future • 22 kg overall mass • Field trials in 2007 • NASA trials in 2009 • 2nd generation: 8 devices
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Titan Medical Inc. (CA) • KUKA’s 7 DOF lightweight arm/ new, custom arms • FDA submission in late 2014 • PI: Dr. Rayman • IPO + grants • 2008–
Amadeus Composer/Maestro
Cre
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: Tit
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al In
c.
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• Advanced Laparoscopy through Force-RefleCT(X)ion • Sofar S.a.P. (Milan, IT) • NES Academy, EU grant support • 2006–
ALF-X
Credit: Sofar S.a.P.
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• Surgica Robotica & University of Verona • 5 years of development , 2 generations • Based on NASA JPL’s RAMS (1994–98) • EU grant support • 6 +3 DOF • euRobotics Technology Transfer Award 2011 • CE mark by end 2011
• First tests (with 2-3 robots) • pancreatic resection (cryoablation at U. Padova ) • aortic aneurism treatment
Surgenius
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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Eye surgery robot prototype • Tremor filtering, 1:10 motion scaling • Haptic feedback, RCM mechanism • Tools of a diameter of 0.5 millimeter • Fast instrument changing SOFIE: Surgeons Operating Force-feedback
Interface Eindhoven
Credit: Tech. University of Eindhoven
Tech. University of Eindhoven
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• Deutsches Zentrum für Luft- und Raumfahrt (DLR) • KineMedic (discontinued) • MIROsurge
• 10 kg weight, 3 kg payload • 3 robot, 1 animal trial
DLR robots
Credit: DLR
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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Huatuo/Vesalius Platform (HVP) 31
ICEMR, IRCAD Taiwan • Began at K.U. Leuven • Modular design • Laparoscopic CO2 laser ablation • PI: Dr. Tang
Cre
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: IC
EMR
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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China 32
Micro Hand A (妙手A) Tianjin University and Nankai University • Tested at the Tianjin Medical University General Hospital
(June 2010–) • And also Southern Medical University
Orthopedic robot Xinqiao hospital in Chongqing • 2010, first trial
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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Japan 33
University of Waseda • Beating heart surgery robot • MRI-compatible robot
NAVIOT (Hitachi Co.) • First commercialized robot in Japan • 5-bar linkage mechanism for safety
design to restrict moving area
Credit: U. Waseda
Credit: Hitachi
Credit: U. Waseda & Hitachi
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Japan II 34
Tokyo Women’s Medical University • Workspace Securing Manipulator • In vivo surgery on porcine
University of Tokyo • MM1 robot for neurosurgery
Credit: U. Tokyo
Credit: U. Tokyo
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South Korea 35
Lapabot National Cancer Center, Goyang • 5 DOF slave arms • 5 mm conventional lapar tools
Credit: National Cancer Center
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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Canada 36
Simris (neuroArm) IMRIS (2010–) • Developed by Univ. Calgary and MD Robotics
• With experience gained at the Space Station SPDM • 1 systems, MR compatibly up to 3 T • First brain tumor patient: 2008 • Looking for FDA clearance in 2012
• Treating up to 120 patients
Credit: Univ. of Calgary, www.neuroarm.org
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Új fejlesztések Bottom line: better clinical outcome
• Augmenting accuracy and/or efficacy
• Increasing the added-value
• Providing smarter tools
Future trends 37
• Task specificity • e.g. prostate biopsy robots
• Reduced size • micro/nanorobot
• Increased safety • MR compatibility
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Similar to NOTES • Nanyang Technological University, Singapore
• CardioArm (Carnagie Melon)
• Suturing machines
Phee et al. (2008)
CardioArm - CMU
Gill et al. (2008)
SRI Tool
Single-port devices 38
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Lenyelhető robotok Prior only for imaging • PillCAM
Now with actuators • Scuola Sup. St. Anna:
– Capsule robot
SSSA
Swallow-able devices 39
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• ARAKNES project
– EU FP7 consortium
– Scuola Superior Sant’ Anna, Pisa (coordinator)
– www.araknes.org
Tethered robots 40
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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Small-scale MIS robotics
University of Nebraska D. Oleynikov et al.
41
Un
iv. N
ebra
ska
[McCormick, 2011]
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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• MR compability
– JHU/Queens brachy robots
– WPI AIM lab robots
– Harvard/AIST open bore MR robot
Credit: CISST ERC, Harvard Medical School, WPI
In-vivo imaging
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Deployment of telemedicine 43
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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Surgery in space
On board & in simulated environments
NASA zero G experiments • On board of a DC-9 hyperbolic aircraft • Simulated surgery (2007) • Suturing with M7 robot • Human control / automated task execution NASA NEEMO program • 14 missions in an underwater habitat in Florida • Robotic surgery mission objectives
• Telesurgery with AESOP (2004) • Simulated procedures with the M7 (2006) • Telesurgery with Raven and M7 (2007)
Zero G surgeries • First surgery in weightlessness on a rat (2003) • Removal of a cyst from the arm of a human (2006) • Parabolic flights: 20-25 s of microgravity • ESA Zero-G plane (modified Airbus A-300)
Cre
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: ESA
, NA
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44
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Need for standards et al.
To ensure patient safety • Minimize risk
• Resolve liability
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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Regulatory approach 46
“Robots for medical intended use” EC Machinery Directive: • Non-medical personal care robots -> machines for performing “aiding
actions, and actions contributing directly towards improvement in the quality of life of humans, except medical application”
EC Medical Device Directive: • Medical robots are classified and will be regulated as medical electrical
equipment and systems which are to be used to diagnose, treat or rehabilitate patients from medical conditions
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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Current standards
• risk analysis (system definition, hazard identification and risk estimation) • risk evaluation (determine risk tolerance levels) • risk control (implementing the right action for maximum safety)
Risk management (from industrial robotics)
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• IEC 60812 International Standard on Fault Mode and Effects Analysis (1985)
• IEC 1508 Functional Safety: Safety-Related Systems (1995)
• European Norm (EN) 1441 on risk management (1997)
• American National Standards Institute (ANSI) R15.06 standard for industrial robot safety (1999)
• GHTF/SG3/N99-10:2004 Quality Management Systems—Process Validation Guidance (2004)
• IEC 62304 on Medical Device Software—Software Life Cycle Processes (2006)
• IEC 61025 Fault Tree Analysis (Ed. 2.0, 2006)
• ISO 14971 Application of Risk Management to Medical Devices (2007)
• IEC 60601 international standard on Medical Electrical Equipment (Ed. 3.0, 2010)
• IEC 1508 draft standard on Functional Safety for software developers
Standards and regulations
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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Regulatory bodies
Food and Drug Administration (USA) • Pre-Market Approval (PMA): long, thorough, expensive • Premarket notification, 510(k): doctrine of “substantially equivalency” • FDA Quality System Regulations (QSR) • All surgical robots went down 510(k)
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European Economic Community (EU) • CE mark (Conformité Européenne) managed by independent Notified Bodies • ISO 9000 Quality Standards family (ISO 9001:2000) – possibility of self-certification • New: 2007/47/EC extension to 1993/42/EEC Medical Device Directive
more clinical data required
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New standardization efforts
ANSI/AAMI ES60601-1:2005 Medical electrical equipment New amendment for medical robots (due August 2013)
• defining technical requirements • streamlining the application of risk management • clarifying the definition of essential performance • identifying essential performance and mitigating the risk
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IEC 60601-1 updates • supportive medical data as evidence for the safety and performance • risk assessment and analysis even for OEMs • from June 2012 in the EU, planned from 2013 in the USA
510(k) is under fire • 510(k) Working Group • Task Force on the Utilization of Science in Regulatory Decision Making
Joint ISO–IEC workgroup on Medical Robot standards • ISO/TC 184/SC 2 (Robots and Robotic Devices) • IEC/SC 62A (Common Aspects of Electrical Eq. used in Medical Practice)
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Building from scratch
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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Robotic systems in accordance with ISO 8373, based on application
Categorization of robots
Gu
rvin
der
et
al. 2
01
2
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Personal service robots
Gu
rvin
der
et
al. 2
01
2
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Ambiguous issues
Cre
dit
: DA
RPA
,RIB
A
VS.
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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Ambiguous issues
Cre
dit
: DA
RPA
,HA
L
VS.
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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Ambiguous issues
Cre
dit
: TU
G, A
maz
on
—K
iwa
VS.
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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Ambiguous issues
Cre
dit
: AIB
O, P
aro
VS.
¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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Accuracy metrics
Originating from the industry
Inherent accuracy of system components
Accuracy vs. repeatability
Problems with measurements
[Simon et al. 1995]
Use of phantoms (artifacts) for testing Trying to replicate clinical conditions as much as possible
Accuracy of treatment delivery is important Difficult to measure routinely Single numbers are not meaningful
Ultimate goal is task specific measurement of uncertainty
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Accuracy numbers
All
val
ues
are
in
mm
Robot Company Intrinsic accuracy
Repeat. Application
accuracy
Puma 200 Memorial Medical Center 0.05 2
ROBODOC Int. Surgical Systems Inc.
Curexo Tech. Corporation 0.5–1.0 1.0–2.0
NeuroMate Inn. Medical Machines Int.
Int. Surgical Systems Inc.
Renishaw plc
0.75 / 0.6
0.36 ± 0.17 0.15
0.86 ± 0.32
1.95 ± 0.44
da Vinci Intuitive Surgical Inc. 1.35
1.02 ± 0.58
da Vinci S Intuitive Surgical Inc. 1.05 ± 0.24
CyberKnife Accuray Inc. 0.42 ± 0.4
0.93 ± 0.29
B-Rob I ARC GmbH, Seibersdorf 1.48 ± 0.62
B-Rob II ACMIT (ARC GmbH) 0.66 ± 0.27
1.1 ± 0.8
SpineAssist Mazor Surgical Technologies 0.87 ± 0.63
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Standardization efforts
ASTM working group F04.05 (2004–) • “Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems (CAOS)“
Need of objective, comparable assessment
• Standards for procedures cutting, drilling, milling, reaming
• Distinct applications joint replacement, implant nailing, osteotomy, etc.
• Certain imaging modalities fluoroscopy, CT, MRI, ultrasound
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NIST Phantom (2007) • Computer-Assisted Orthopaedic Hip
Surgery (CAOHS) Artifact
• Designed to mimic hip joint
Courtesy of N.Dagalakis, NIST, U. Nebraska
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Degree of Autonomy
DoA: the only missing piece
• Risks and hazards originating from DoA In current and future medical electronic equipment
• ALFUS approach IEEE workgroup for Autonomy Levels for Unmanned Systems
• DoA levels identified D.B. Kaber, M.R. Endsley, The effects of level of automation and adaptive automation on human performance, situation awareness and workload in a dynamic control task; Theor. Issues in Ergon. Sci., 5(2), pp. 113-153, 2004
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¤ Seoul National University seminar ¤ Korea , 10.25.2012. ¤
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SurgRob a blog on CIS and medical robotics
http://surgrob.blogspot.com
Post script
For more information:
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Takeaway
“Get smarter people than you are, and make them excited about your problem!”
/R.H. Taylor/
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”If you enjoy your job, you will never have to work for your entire life.”
/ Teik Seng Tan/