Simulation in Healthcare: Transforming Education University of Minnesota Academic Health Center Minneapolis, MN November 28, 2005 The Future of Surgery Paradigm Change in Surgical Simulation Richard M. Satava, MD FACS Professor of Surgery University of Washington Program Manager, Advanced Biomedical Technologies Defense Advanced Research Projects Agency (DARPA) and Special Assistant, Advance Medical Technologies US Army Medical Research and Materiel Command and the

Air Force 1 - refit Unofficial Administration request UNCLASSIFIED

“The Future is not what it used to be” ….Yogi Berra Disruptive Visions

“The Future is here …... it’s the Information Age” Current Visions

New technologies that are emerging from Information Age discoveries are changing our basic approach in all areas of medicine... EXAMPLES Fundamental Concept

Holomer Total body-scan for total diagnosis Satava March, 2004 From visible human to Virtual Soldier Multi-modal total body scan on every trauma patient in 15 seconds

Virtual Autopsy Wound Tract Less than 2% of hospital deaths have autopsy Statistics from autopsy drive national policies

Why robotics, imaging and modeling & simulation Healthcare is the only industry without a computer representation of its “product” A robot is not a machine... it is an information system with arms... A CT scanner is not an imaging system it is an information system with eyes... thus An operating room is an information system with...

Total Integration of Surgical Care Joel Jensen, SRI International, Menlo Park, CA Minimally Invasive Surgery Pre-operative planning Intra-operative navigation Remote Surgery Simulation & Training

Prof. Jacques Marescaux, MD IRCAD, Strasbourg FRANCE Remote telesurgery Dr. Mehran Anvari, MD McMaster Univ, Toronto CANADA “Operation Lindberg” First remote and trans-Atlantic Telesurgery procedure ROUTINE telesurgery from Hamilton to North Bay 300 mile distant

“TriCorder” Point-of-care noninvasive therapy High Intensity Focused Ultrasound for Non-invasive Acoustic hemostasis HIFU Courtesy Larry Crum, Univ Washinton Applied Physics Lab

The LSTAT Courtesy of Integreated Medical Systems, Signal Hill, CA “...is aware of everything (patient)...” Defibrillator Ventilator Suction Monitoring Blood Chemistry Analysis 3-Channel Fluid/Drug Infusion Data Storage and Transmission On-board Battery On-board Oxygen Accepts Off-Board Power and Oxygen Total Patient Awareness

212th MASH Deployed with LSTAT - Combat Support Hospital LSTAT Deployment to Kosovo - March 2000 Courtesy of Integreated Medical Systems, Signal Hill, CA

LSTAT Lite LSTAT for far-forward battlefield – less than 50 lbs LSTAT – Back pack version

Nightingale UAV Goal  Identify “optimum” VTOL UAV design  Create a new VTOL UAV tailored to the operational need LSTAT Or:

Why now? VTOL UAV technology is maturing rapidly enough to minimize risk.

Classic Education and Examination

Laparoscopic Simulator with tactile feedback Courtesy Murielle Launay, Xitact, Lausanne Switzerland Laparoscopic hysterectomy Courtesy Michael vanLent, ICT, Los Angeles, CA LapSim simulator tasks - abstract & texture mapped Courtesy Andres Hytland, Sugical Science, Gothenburg, Sweden, 2000 Surgical Simulators Simulation and Objective Assessment

ENT Sinusoscopy Simulator Lockheed Martin 1999 Haptics Full System

“Blue Dragon” passive recording device Courtesy Blake Hannaford, University of Washington, Seattle

Hand motion tracking patterns Ara Darzi, MD. Imperial College, London, 2000 Novice Intermediate Expert Objective Assessment

Paradigm Change All Surgical Education & Training Adhere to the 6 competencies (ACGME & ABMS) Curriculum, not the simulation Validation of the curriculum (and simulator) Criterion-based (proficiency level) training for

Speculation on Future Simulation will become part of surgical procedures (eg surgical rehearsal/assessment) Training will be continuously assessed (Black box – Ara Darzi) Training will be embedded in robotic surgery Surgical rehearsal will join robotic surgery

The next steps Intelligent tutors Complex procedures Digital libraries Surgical Rehearsal

Education Train & Assess Certification Research Simulators Robotics Virtual reality Clinical Practice Patient care Procedural skills Professionalism Training Center Clinical Trials and Outcome studies Clinical Knowledge Base Curriculum Research Validation Studies Assessment Efficacy Pillars of Healthcare Education

Training Competency Criterion-based Faculty commitment Research Curricula Simulators Administration Resources (Personnel) Space & simulators Audit & Results reporting Fiscal responsibility Comprehensive Training Center Grants Contracting Graduate study RRC review Scheduling Protected time Curricula Assessment tools Validation studies American College of Surgeons Requirements for Endorsement* American College of Surgeons Requirements for Endorsement* *Comprehensive Training Center

Superhuman Robots! The Touch Lab, MIT Movie: Alien

“Penelope” – robotic scrub nurse Michael Treat MD, Columbia Univ, NYC. 2003

Integrating Surgical Systems for Autonomy The Operating Room (personnel) of the Future Satava March, 2000 Surgeon Assistant Scrub Nurse Circulating nurse 100,000

The Operating Room of the Future

SATAVA 7 July, 1999 DARPA Fighter Pilots – until 2002 Fighter Pilots – Beyond 2003 Predator 2003

Robotic Medical Assistant SATAVA 7 July, 1999 DARPA Nursing shortage crisis Applicable at all levels Hospitals Clinics Nursing Home Assisted living Courtesy Yulun Wang, InTouch Technologies, Inc, Goleta, CA

“The Future is not what it used to be” ….Yogi Berra Disruptive Visions

Scientific Method A Paradigm Change? Hypothesis Study DesignExperimentResults Reporting Hypothesis Study Design Modeling & Results Experiment Results Reporting Simulation (Preliminary) Modeling & Simulation

The Information Age is NOT the Future The Information Age is the Present... There is something else out there SATAVA 7 July, 1999 DARPA

Clayton M Christensen

BIO INTELLIGENCE AGE TECHNOLOGY DEVELOPMENT CONSUMER ACCEPTANCE AGRICULTURAL AGE INDUSTRIAL AGE BIOINTELLIGENCE AGE INFORMATION AGE TIME (year) 2000 BC02000 AD Satava 29 July 99

BIOLOGIC PHYSICAL INFORMATION FUTURE Robotics HPCC/WWW MEMS/Nano Genomics Bioinformatics Biocomputation Biosensors Biomaterials Biomimetic Satava 2 Feb 1999 The BioIntelligence Age

The key to the future is multi-disciplinary teams

University of Montana, 1999

University of Wisconson, 1999

Biomimetic Micro-robot Courtesy Sandia National Labs

Capsule camera for gastrointestinal endoscopy Courtesy Paul Swain, London, England

Greg Kovacs. Stanford University, 1990 “BrainGate” John Donohue, Brown University, 2001 Richard Andersen, CalTech, 2003

Recorded activity for intended movement to a briefly flashed target. TARGETMOVEMENT Time PLAN Courtesy Richard Andersen, Cal Tech, Pasadena, CA Brain Machine Interface – Controlling motion with thoughts

Thoughts into Action Miguel Nicholai, Duke University, 2002 Satava March, 2000 Direct brain implant control of robot arm

Rheo Bionic knee Ossur, Reyknavik, Iceland C-leg Otto Bock, Minneapolis, MN Intelligent Prostheses

Artificial Retina Multi-disciplinary team from USC Doheny Retinal Institute, Oak Ridge National Labs, North Carolina State University and Johns Hopkins University Courtesy Jim Weiland, USC Doheny Retina Institute, Los Angeles, CA

Tissue Engineering Liver Scaffolding Artificial Blood Vessel J. Vacanti, MD MGH March, 2000 Artificial Ear

Courtesy of J. Vacanti, MD MGH March, 2000

Cold Spring Harbor Laboratory, Long Island, NY Femtosecond Laser (1 x 10 –15 sec) Time of Flight Spectroscopy Cellular opto-poration Los Alamos National Labs, Los Alamos NM

BioSurgery Satava September 2003

Spider silk protein as biomaterial -BioSteel Nexia Biotechnologies, Montreal Canada Cross section of synthetic fiber Spinnerette of spider Orb spider - web

Cold Spring Harbor Laboratory, Long Island, NY Femtosecond Laser (1 x 10 –15 sec) Time of Flight Spectroscopy Cellular opto-poration Los Alamos National Labs, Los Alamos NM

BioSurgery Satava September 2003

Relative size of subjects Alaska Black Bear Artic Ground Squirrel Research in hibernation suspended animation hypometabolic states resuscitation reperfusion

Brian M. Barnes, Institute of Arctic Biology, University of Alaska Fairbanks 11/02 Institute of Arctic Biology’s Toolik Field Station, Alaska's North Slope Suspended Animation

metabolic rate (2%) active hibernating body temp. 37 o C -2 o C gene ongoing transcription function and translation suppressed heart rate resp. rate 150 <1 (breaths/min) (beats/min) (mlO 2 /g/h)

Confidential

When this be accomplished

The rate of new discovery is accelerating exponentially The changes raise profound fundamental issues Moral and ethical solutions will take decades to resolve Technologies will change the Future Differing responses to scientific discovery by various sectors TIME Rate of Change Society Business Sector Technology Healthcare

Moral and Ethical Issues Raised by Technological Success Summary Should we do research in areas we may not be able to control? (eg, genetics, cloning, nanobots, intelligent machines?) Will prolonging life through technology result in more disease in the overall population Can we change medicine from treatment to prevention of disease In defeating diseases, will technology change a human into a combination of man and machine - what does it mean to be “human” How will we decide who gets the technology, especially in 3rd World SATAVA 7 July, 1999 DARPA 6

And just what are these profound moral and ethical issues?

“The practice is contrary to human dignity and is criminal” French President Jacques Chirac Clonaid scientist Brigitte Boisselier said a baby girl - nicknamed Eve - was born in the US after the genetic material from a woman's skin cell was fused with one of her eggs. Dr Boisselier said four other women were due to give birth to baby clones in the coming weeks - one in Europe, another in North America and two in Asia. Demands grow for human clone ban Advocates argue cloning can help infertile couples There are growing demands for a ban on human cloning after claims that a girl born on Thursday is an exact genetic replica of her mother. Clonaid scientist Brigitte Boisselier said four more clones will be born soon. French President Chirac has called on all countries to rally behind a Franco-German proposal for a global ban on human cloning which has been submitted to the United Nations. US President George W Bush says the process is "deeply troubling". Scientists remain sceptical of the success claimed by the Clonaid company, which is linked to a sect that believes aliens created humans by cloning 25,000 years ago. But legislators in Britain and elsewhere say there has to be discussion and introduction of rules for the practice of scientific methods which could produce a cloned baby, even if Clonaid's claims are untrue. “These technologies... are raising new moral and ethical morasses for us.” Dr Ian Gibson British legislator Saturday, 28 December, 2002, 14:28 GMT.

February 12, 2004 South Korean team demonstrates cloning efficiency for humans similar to pigs, cattle | Thersa Tamkins After outlandish claims, a few media circuses, and some near misses by legitimate researchers, a team of South Korean researchers reports the production of cloned human embryos. The findings, were released Wednesday (Science, DOI: /science , February 12, 2004).Wook Suk Hwang and Shin Yong Moon of Seoul National University used somatic cell nuclear transfer to produce 30 human blastocysts and a single embryonic stem cell line; SCNT-hES- 1. Using 242 oocytes and cumulus cells from 16 unpaid donors, the group achieved a cloning efficiency of 19 to 29%, on par with that seen in cattle (25%) and pigs (26%). Human embryos cloned Chinese Cloning Control Required Tuesday 16 April, 2002, 10:41 GMT 11:41 UK Strict ethical guidelines are needed in China to calm public fears about new cell technologies such as cloning, the country's leading scientist said. Professor Ching-Li Hu, the former deputy director of the World Health Organization, was speaking at the Seventh Human Genome Meeting in Shanghai. His call follows recent reports that Chinese scientists are making fast progress in these research fields. One group in the Central South University in Changsa is said to be producing human embryo clones, while another team from the Sun Yat-sen University of Medical Sciences in Guangzhou is reported to have fused human and rabbit cells to make tissues for research.

Genetically “designed” child 1997 Gregory Stock Jeffery Steinberg, MD Fertility Institutes of Los Angeles Five "designer babies" created for stem cells Five healthy babies have been born to provide stem cells for siblings with serious non-heritable conditions. This is the first time "savoir siblings" have been created to treat children whose condition is not genetic, says the medical team.The five babies were born after a technique called preimplantation genetic diagnosis (PGD) was used to test embryos for a tissue type match to the ailing siblings, reports the team, led by Anver Kuliev at the Reproductive Genetics Institute in Chicago, US.The aim in these cases was to provide stem cells for transplantation to children who are suffering from leukaemia and a rare condition called Diamond-Blackfan anaemia (DBA)."It's a big step, because it gives people another option," says Mohammed Taranissi, at the Assisted Reproduction and Gynaecology Centre, London, UK, one of the team. "Before that the only option was to look in the siblings and immediate family to see if you had a match or alternatively to just keep trying [to have a baby which matches]."He told New Scientist that people trying to conceive a child naturally as a tissue match for a sick sibling had only a one in five chance. This method can also lead to terminations where the foetus is not a tissue match for the sibling."If you do it this way, the chance of finding a match is 98 per cent." 'Unlawful and unethical' However, the use of this technology to provide a "designer baby" to treat an ill sibling is highly controversial.A UK couple involved in this study travelled to the US for treatment after the UK's Human Fertilisation and Embryology Authority (HFEA) ruled that they could not create a tissue-matched sibling as a stem cell donor to their son.In-vitro fertilisation (IVF) and tissue-typing was used in the US to give the Whitakers a perfectly matched baby boy to help their son 1.Verlinsky Y, Rechitsky S, Sharapova T, Morris R, Taranissi M and Kuliev A. Preimplantation HLA Testing. JAMA (2004) 29: 2079

RENO, Nev. - On a farm about six miles outside this gambling town, Jason Chamberlain looks over a flock of about 50 smelly sheep, many of them possessing partially human livers, hearts, brains and other organs. The University of Nevada-Reno researcher talks matter-of-factly about his plans to euthanize one of the pregnant sheep in a nearby lab. He can’t wait to examine the effects of the human cells he had injected into the fetus’ brain about two months ago. “It’s mice on a large scale,” Chamberlain says. As strange as his work may sound, it falls firmly within the new ethics guidelines the influential National Academies issued this past week for stem cell research. In fact, the Academies’ report endorses research that co- mingles human and animal tissue as vital to ensuring that experimental drugs and new tissue replacement therapies are safe for people. Doctors have transplanted pig valves into human hearts for years, and scientists have injected human cells into lab animals for even longer. Biological mixing of species But the biological co-mingling of animal and human is now evolving into even more exotic and unsettling mixes of species, evoking the Greek myth of the monstrous chimera, which was part lion, part goat and part serpent. In the past two years, scientists have created pigs with human blood, fused rabbit eggs with human DNA and injected human stem cells to make paralyzed mice walk. Particularly worrisome to some scientists are the nightmare scenarios that could arise from the mixing of brain cells: What if a human mind somehow got trapped inside a sheep’s head? The “idea that human neuronal cells might participate in 'higher order' brain functions in a nonhuman animal, however unlikely that may be, raises concerns that need to be considered”. Mice with human brains In January, an informal ethics committee at Stanford University endorsed a proposal to create mice with brains nearly completely made of human brain cells. Stem cell scientist Irving Weissman said his experiment could provide unparalleled insight into how the human brain develops and how degenerative brain diseases like Parkinson’s progress. Stanford law professor Hank Greely, who chaired the ethics committee, said the board was satisfied that the size and shape of the mouse brain would prevent the human cells from creating any traits of humanity. Just in case, the committee recommended closely monitoring the mice’s behavior and immediately killing any that display human-like behavior. Weissman, who has already created mice with 1 percent human brain cells, said he has no immediate plans to make mostly human mouse brains, but wanted to get ethical clearance in any case. A formal Stanford committee that oversees research at the university would also need to authorize the experiment. Sheep that have partially human livers, hearts, brains and other organs are shown here at the University of Nevada, in Sparks, Nev., on April 27. The Associated Press April 29,2005 Scientists create animals that are part-human Stem cell experiments leading to genetic mixing of species

Extending Longevity A strain of mice that have lived more than three normal lifespans Should humans live 200 years? Life extension Life extension consists of attempts to extend human life beyond the natural lifespan. So far none has been proven successful in humans. Several aging mechanisms are known, and anti- aging therapies aim to correct one or more of these: Dr. Leonard Hayflick discovered that mammalian cells divide only a fixed number of times. This "Hayflick limit" was later proven to be caused by telomeres on the ends of chromosomes that shorten with each cell-division. When the telomeres are gone, the DNA can no longer be copied, and cell division ceases. In 2001, experimenters at Geron Corp. lengthened the telomeres of senescent mammalian cells by introducing telomerase to them. They then became youthful cells. Sex and some stem cells regenerate the telomeres by two mechanisms: Telomerase, and ALT (alternative lengthening of telomeres). At least one form of progeria (atypical accelerated aging) is caused by premature telomeric shortening. In 2001, research showed that naturally occurring stem cells must sometimes extend their telomeres, because some stem cells in middle-aged humans had anomalously long telomeres. April 14, 2004

Gaak Courtesy Professor Noel Sharkey, Sheffield Unversity, London "Thinking" robot in escape bid Scientists running a pioneering experiment with robots which think for themselves have caught one trying to flee the centre where it "lives". The small unit, called Gaak, is one of 12 taking part in a "survival of the fittest" test at the Magna science centre in Rotherham, South Yorkshire, which has been running since March. Gaak made its bid for freedom after it had been taken out of the arena where hundreds of visitors watch the machines learning how to repair themselves after doing daily battle. Professor Noel Sharkey said he turned his back on the drone, but when he returned 15 minutes later he found it had forced its way out of the small make-shift paddock it was being kept in. He later found it had travelled down an access slope, through the front door of the centre and was discovered at the main entrance to the car park when a visitor nearly flattened it with his car. TECHNOLOGY NEWS Intelligent “Living Robot” Uses genetic algorithms to “learn” Kismet Courtesy Rosalind Picard, MIT Affective Computing Lab, Boston, MA ESCAPED

Will Machines become “smarter than humans? ROBOT Hans Moravec Ray Kurzweil Humans vs Machine Humans 4.0 X cps Red Storm 3.5 X cps Moore’ s Law “computer power doubles every 18 months” Do the Math !! Who is smarter now?? The Age of Spiritual Machines WHEN COMPUTERS EXCEED HUMAN INTELLIGENCE

CAN I REPLACE MY B O D Y ? If I replace 95% of my body Am I still “human”? Artificial organs Smart Prostheses Genetic engineering Regeneration What does it mean to be human ?

Future interface for anthropomorhpic mobile robots David Hanson, Hanson Robotics Inc, Dallas, TX

For the first time in history, there walks upon this planet, a species so powerful, that it can CONTROL ITS OWN EVOLUTION, at its own time and choosing … … homo sapiens. Who will be the next “created” species? The Ultimate Ethical Question?

Do Robots Dream ?