Medical Automation 2007NCC Lansdowne VA28-30 October 2007

NOTES 2007Innovative intersection or deadend?

Michael R. MarohnAssociate Professor / Director of Minimally Invasive Surgery

Johns Hopkins University School of Medicine

and

Whiting School of Engineering

ConsultantDefense Advanced Research Projects Agency (DARPA)

and

Telemedicine & Advanced Technologies Research Center (TATRC)

“The Future is not what it used to be”

….Yogi Berra

Disruptive Visions

Bio-Information Age

• Digital age (i.e.: computer based) harnessing of biologic information– Systems biology

• Interventionalist view of emerging technologies– Surgical Robotics– Integrating Imaging and Intervention– Informatics– NOTES

Perspective

• What is NOTES?– Next ‘Big Thing?’

• Story line about innovation, or not…• Lessons learned, partially from

NOSCAR– Interdisciplinary to transdisciplinary

• Asking the right questions• Roadmap for future innovation

Overview: 4 topics

• Brief NOTES history– Lessons from Minimally Invasive Surgery

• Current status of NOTES• Future challenges?

– NOTES - Current technology limitations

• Future transdisciplinary roadmap– Intersection of endoscopy, laparoscopy,

and robotics• Challenge and opportunity

Revolutions in Surgery

• Anesthesia• Asepsis• Antibiotics• Surgical pathology

–Golden Age of Surgery• 19th/20th centuries

‘Nintendo’ Surgery Revolution

• 1987 – 1st Lap chole - Mouret, Lyons, France

• 1990 – Lap chole expansion in USA• 1992 – Lap chole = ‘standard of care’• 1992 – Lap surgeries for adrenal, anti-

reflux, colon, kidney, thoracic, trauma, …• 2007 – Minimally Invasive Surgery

impacts all surgical specialties

Current surgery technology

• 21st century surgery on 15 th century platform with 19 th century instruments

• Operating rooms – isolated worlds run by feudal lords with patients strapped to slabs

• Instruments – primitive, rigid, inflexible, ergonomically awkward, limited tactile sense

• Visualization – 2-dimensional vision of 3-dimensional space

Laparoscopic instruments:

Modified ‘chop sticks’ with limited degrees of motion, precision, tactile feedback, and poor ergonomics

Laparoscopic visualization

• Two-dimensional vision of three-dimensional space

Laparoscopic Skill levels for most surgeons?

• General surgery – basic skills by all, but 90% of advanced cases are performed by <20%

• Urology – complex cases, yet <2% with advanced skills

• Other surgical specialties?• Future? Wizards, or better

enabling technology…

Next surgery revolution?

• Laparoscopic (MIS) / ‘Nintendo’ Surgery– Technology revolution?

• 3D to 2D vision• ‘Chop sticks’ as instruments

– Transition technology to the 21st century• Industrial revolution to Information Age?

– Is Surgical Robotics the next revolution?(computer assisted surgery)

Design challenges:

What do we need?

‘Smart’Technology

Solutions?

• High tech:-Miniaturization-Articulating hand held instruments-Robotics-3D vision

USUHS/ Surgery

Rocket science at work…

Surgical Robotics: Instruments

Hand instruments that mimic hands, not ‘chop sticks’

–Allows surgeon full 6 degrees of freedom

–Mimics human wrist/ ‘open’surgery

Two side-by-sidecameras create stereoscopicthree-dimensionalimage

True binocular3D vision

Surgical Robotics: Visualization

Still a prototype…

• daVinci S, introduced February 2006

Limitations•No haptics•Multi-quadrant surgery

Improvements•Fast foolproof setup•Rapid instrument exchange •Multi-quadrant access •Interactive video displays

Enabling Milestones

• 1946 Eniac• 1947 Transistor• 1959 Integrated circuit• 1961 Unimate• 1971 Microprocessor• 1994 Aesop• 1996 Sojourner to Mars• 1999 DaVinci & Zeus

March of the Microprocessor CHIP PUBLIC

DEBUT

INITIAL

COST

NUMBER OF

TRANSISTORS

INITIAL

MIPS*

4004 11/71 $ 200 2,300 0.06 8008 4/72 $ 300 3,500 0.06 8080 4/74 $ 300 6,000 0.60 8086 6/78 $ 360 29,000 0.30 8088 6/79 $ 360 29,000 0.30 ¡286 2/82 $ 360 134,000 0.90 ¡386 10/85 $ 299 275,000 5.00 ¡486 4/89 $ 950 1.2 MILLION 20.00 PENTIUM 3/93 $ 878 3.1 MILLION 100.00 PENTIUM PRO 3/95 $ 974 5.5 MILLION 300.00 PROJECTIONSPROJECTIONSPROJECTIONSPROJECTIONS 786 1997 $ 1,000 8 MILLION 500.00 886 2000 $ 1,000 15 MILLION 1,000.00 1286 2011 N/A 1 BILLION 100,000.00 * Millions of instructions per second DATA: INTEL CORP., DATAQUEST INC.

Moore’s law, amazingly, continues… predicts doubling of computer power every 6 months

How this relates to NOTES

Hopkins MedicineMagazine,

Spring/Summer 2007

NOTES update 2007

• What is NOTES?– Natural Orifice Trans-Lumenal

Endoscopic Surgery (NOTES) best describes this emerging area

– Extension of minimally invasive surgery (MIS) from laparoscopy to ‘incisionless’ intervention…

Evolution of Abdominal Evolution of Abdominal Evolution of Abdominal Evolution of Abdominal

Surgery?Surgery?Surgery?Surgery?

NOTES CholecystectomyNOTES Cholecystectomy

Endoscopy evolution

Endoscopy evolution

• 1957: Basil Hirschowitz invented fiberoptics specifically for the endoscope- resulting in the beginning of flexible endoscopy

• 2007: 50th anniversary of the flexible endoscope unimpeded by significant progress

Brief NOTES history

• 1996 Apollo group (Tony Kalloo et al)– Group of gastroenterologists exploring

NOTES possibilities

– Funding: Olympus– 1996-2005 progress: Limited, recognition

of need for collaboration with surgeons

Brief NOTES history

• 2002 Reddy and Rau, first clinical NOTES application: transgastric appendectomy – Team: Surgeon and Gastroenterologist

Transgastric appendectomy

Courtesy of N Reddy, Hyperbad India 2005

Reddy & Rau have performed20 trans-gastric append-ectomies in 5 years

So What’s Next ?

Collaborative initiative

• Surgeons* and Gastroenterologists– 2004-2005: ASGE (Apollo group) and

SAGES leadership discussed potential for NOTES and need for collaboration

– 7/22-23/2005: ASGE/ SAGES retreat in New York, including 14 surgeons & gastroenterologists to define a ‘roadmap’for NOTES

*surgical endoscopy heritage: EGD, ERCP, PEG…

NOSCAR July 2005

NOSCAR

• NOSCAR established: Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR)

• ‘White paper’ published jointly by ASGE & SAGES 2/2006 outlining definitions, fundamental challenges, and future directions Rattner D, Kalloo A, et al. Surg Endosc 2006 Feb 20(2):329-333

‘White Paper’: Challenges to safe introduction of NOTES

1. Access to peritoneal cavity

2. Gastric (intestinal) closure3. Prevention of infection4. Development of suturing

& anastomotic devices5. Spatial orientation6. Training

7. Development of multi-tasking platform to accomplish procedures

8. Management of intraperitoneal complications

9. Physiologic untoward events

10. Compression syndromes

Other issues?

2/2006: NOTES roadmap published concurrently by ASGE and SAGES

Scottsdale NOTES conference - March 2006

• Working groups focused on ‘challenge’ topicsidentified in NOSCAR ‘white paper’

• Collaborative vision proposal to ‘herd the cats’…

• Unlike laparoscopy, where cholecystectomy rapidly expanded MIS, there is NO identified NOTES target procedure

• Still, strong interest in potential of NOTES to enable the future - key questions remain

Boston NOTES conferenceJuly 2007

• Working groups focused on ‘challenge’ topicsidentified in NOSCAR ‘white paper’

• Collaborative vision proposal to ‘herd the cats’…

• Unlike laparoscopy, where cholecystectomy rapidly expanded MIS, there is NO identified NOTES target procedure

• Still, strong interest in potential of NOTES to enable the future - key questions remain

NOSCAR, a Joint Partnership of ASGE and SAGES, Rece ives $1 Million for Ethicon Endo-Surgery "NOTES" ResearchResearch Proposals are Due December 1, 2006In an effort to encourage research in the innovative field of Natural Orifice Translumenal Endoscopic Surgery (NOTES), Ethicon Endo-Surgery, Inc. has announced a $1,000,000 pledge in research funds to the Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR), a joint effort of The American Society for Gastrointestinal Endoscopy (ASGE) and The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES).

For more information about NOTES, the NOSCAR partne rship, or to access the Request for Proposals, visi t www.noscar.org . Proposals are due electronically by December 1, 2006.

About NOSCARNatural Orifice Translumenal Endoscopic Surgery (NOTES) might represent the next major advancement in minimally invasive therapy. To address this emerging technology, a working group consisting of expert laparoscopic surgeons from SAGES and a group of expert interventional endoscopists representing ASGE have joined together as the Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR) Working Group on NOTES. For more information, visit www.noscar.org.

In past 12 months …

•80 grant submissions- 13 grants awarded December 31, 2006www.noscar.com•January 2007: Additional $500K for NOSCAR researchfrom Olympus-awarded in July 2007•October 2007: Additional $250K from Storz for NOSCAR

In past 12 months …

• Total of $2.25 million committed from vendors for NOTES research– Good news

• Restricted to basic science, not technology development

• Collaborative GI & Surgery teams

– Bad news• Restricted to basic science, not technology

development• Collaborative GI & Surgery only teams- no

engineers!

Current research

• Basic science? SAGES, DDW, EAES…• Physiology of NOTES

– Intraabdominal hypertension• Meireles O, Kantsevoy SV, Kalloo AN, Jagannath SB, Giday SA,

Magno P, Shih SP, Hanly EJ, Ko CW, Beitler DM, Marohn MR. “Comparison of intraabdominal pressures using the gastroscopeand laparoscope for transgastric surgery.” Surgical Endoscopy 2007

– Infection issues• Giday SA, Kantsevoy SV, Kalloo AN, Jaganath SB, Magno P,

Marohn MR. “Infection prevention in NOTES: Randomized controlled trial in aporcine model.” 2nd NOTES Conference 2007

– Immunology of NOTES– Spatial (dis-)orientation

Current applications

• Clinical applications? SAGES, DDW, EAES…– Animal

• Transgastric cholecystectomy, oophorectomy, splenectomy, BTL, GJ (bariatric implications), adrenalectomy…

• Transrectal cholecystectomy

– Human• 1st Transgastric appendectomy in India, 2002, now 20

cases• Transvaginal cholecystectomy (hybrid), New York,

Marc Bressler, 4/2007

Current applications

• Clinical applications? SAGES, DDW, EAES…– Animal

• Transgastric splenectomy, BTL, GJ (bariatric implications), adrenalectomy…

• Transrectal cholecystectomy– Human

• 1st Transgastric appendectomy in India, 2002, now 20 cases

• Transvaginal cholecystectomy (hybrid), New York, Marc Bressler, 4/2007

• 1st Transgastric cholecystectomy (NOTES), Oregon, Lee Swanstrom, 5/2007

Is NOTES the next ‘big thing’?

• Natural• Orifice• Translumenal• Endoscopic• Surgery

Lessons learned from MIS

• Laparoscopic (MIS) / ‘Nintendo’ Surgery– Technology revolution? Probably not…

• 3D to 2D vision• ‘Chop sticks’ as instruments

– Transition technology to the 21st century• Industrial revolution to Information Age?

– What about surgical robotics?(computer assisted surgery)

Future challenges• NOTES is not just about the size of the incision… or

having NOSCAR

• NOTES represents the intersection of laparoscopy and endoscopy

– Laparoscopy at 20 years still using chopsticks and 2D vision

– Endoscopy at 50 years still using the original endoscope

• Even wizards are quickly stymied in the NOTES environment

NOTES needs

Development of modified accessories and endoscopes- for endolumenal and

translumenal intervention

Courtesy of N Reddy, Hyperbad India 20005

Trans Oral Intra-peritoneal Surgery –Future

Courtesy of N Reddy, Hyperbad India 20005

Suture Devices

Eagle ClawApollo ProjectOlympus, Tokyo.

Courtesy of N Reddy, Hyperbad India 20005

Modified Endoscope for Transgastric Surgery

Need fortriangulation

EndoVia- Robotic EMR

Development and testing of a new platform for retroflexed flexible transgastric surgery: cholecystectomy, fundoplication, and

diaphragmatic repair

P. Swain; C. Rothe; M. Bergstrom; P. Park; L. SwanstromUSGI San Clemente, California, Portland, St Mary’s Hospital

and Imperial College, London, Sahlgrenska University Hospital-Östra, Gothenburg Sweden

Courtesy Paul Swain

Transport (TP): platform for translumenal surgery

The USGI MedicalThe USGI Medical®® TransPortTransPort™™

• TP utilizes Shapelock® technology, allowing device to be locked into desired configurations

• Device is introduced in a flexible state, and becomes rigidwhen the physician squeezes the locking handle

Features

The device has 4 channels for instruments of different sizes, one of which will usually be used with a small diameter (5.2 mm) gastroscope

The distal section of the TransPort can be steered freely, allowing the user to see and deliver therapy with efficiency and precision

Buckling and retraction

Forwards force causes flexible instruments to buckle and push gastroscope away from target tissue

Shape-locked transport allow effective retraction of the cystic duct and artery

Retraction forces with a standard flexible scope would result in scope being pulled toward wall

You cannot push rope…

“Reliable gastric closure after NOTES using a novel per-oral flexible stapling device.” Society of American Gastrointestinal and Endoscopic

Surgeons (SAGES) Annual Meeting, Las Vegas, NV, 18-22 April 2007. Meireles O, Kantsevoy SV, Assumpcao LR, Hanly EJ,

Kalloo AN, Marohn MR.

PowerMedical device

Magnetically Anchored Steerable Instruments

• Cadeddu, et al. J of Urology 2002;167:4.– Multiple instruments deployed via a

single trocar– Coupling using permanent magnets– Porcine nephrectomy model– Patent filed

Courtesy Dan Scott

Gallbladder Retractor

• Fundus retraction

• Fixation

– Sutured (transabdominal)

– Clips (transgastric)

Enabling technologies for 21st

century surgery

• Endolumenal/ endovascular access• Digital technology

– Computer assisted surgery & imaging– Machine vision– Image integration with interventional

platforms• Novel energy delivery systems• Molecular level sensors• ‘Smart instruments’

NOTES vision

• 21st century emerging technologies and intersecting disciplines (laparoscopy, endoscopy, and robotics) offer a fertile environment for interventional breakthroughs– Endolumenal– Translumenal– Laparoscopic– Open

Evolving 21st century interventions

Roboticsandadvanced imaging

and guidance

Interventionalendoscopy

Laparoscopicsurgery

NOTES

Recognizing enabling elements

• Central role of the computer as the core enabler of the digital age

• Digital potential…– Human genome– Imaging

– Informatics– Intervention?– Integration?

N. Simaan, R. Taylor, A. Kapoor, P. Kazanzides, P. Flint, MD

Scalable robot for dexterous surgery in small spaces

Remember the 5.2 mm diameterTransport device working lumen?

Snake robot is 4.2 mm diameter

Figure 3. Micro-robotic endoscopy. Physician controlling micro-robot (which has been inserted into the rectum) from endoscope workstation

Figure 2. Translational endoscopy workstation. Physician advancing insertion tube of colonoscope by hand while controlling the tip and valves from endoscopic workstation.

Figure 1. Conventional colonoscopy

Satava RM Future of endoscopy. GI Clin NA, Oct, 1983

Future?Remote GuidedSmartPillcams?

Future?WorkstationFor Snake

Robot?

3D Reconstructions

Virtual surgery?

• 3D image reconstruction• 3D instrument positioning• Simulate surgery before operation• Collaborate, plan ‘best’ surgery• Direct robot to perform ‘best’

surgery

Medical automation?

The Touch Lab, MITMovie: Alien

Smart Endoscope• White paper vision – it is time for a new

endoscope, or vision of GI imaging & intervening– Endolumenal, translumenal, …

• Portfolios of projects– Pill cam potential/ scenario– Computer based work station– Robotic capability/ snake example– Image integration, enhancement– Sensing capability– Confocal microscopy– Intelligent endoscopy…

• Collaborative teams, resources, funding

Transdisciplinary InitiativesDARPA BioFocus 2000

NASA BioAstronautics/Astrobiology

NSBRI Human Systems Integration

NCI Unconventional Projects

NSF National Nanotechnology Initiative

NIH Roadmap, U-54, Quantum…

DoE Virtual Human Project

Consortium CIMITJohns Hopkins’ I4M

Trans-disciplinary initiatives

7 July, 1999DARPA

Programs require . . . . . . inter-disciplinary research teams

Programs are too complex for single support or institution

. . . to be performed on thousands of dollars

Of the previous programs most at >$250 million . . .

Even when DoD funded . . .

. . . they are ideally Dual Use

Success (figure of merit) is in milestones/deliverables . . . . . . not only publications

Importance of the “culture of collaboration”Rand

True revolution

• Bioinformatics/ digital age: integrating informatics, imaging, and intervention

• Evolution from surgery, GI, radiology to transdisciplinary intervention

• ORF to IRF• It isn’t about NOSCAR- NOTES chole v. lap

chole…• Remember the 50 year old endoscope and

20 years of ‘high tech’ laparoscopy• We need to evolve…

Do Robots Dream ?

“Chance favors the prepared mind.”

- Louis Pasteur