Steven S RothenbergClinical Professor of SurgeryColumbia University College of Physicians and SurgeonsChief of Pediatric SurgeryThe Rocky Mountain Hospital For Children
Steven S. Rothenberg, MD-Ownership interest in Just Right Surgical; Consultant for Storz
1.Idea Stage: Won’t work. Been Tried Before.2.Successful Experiments In Animals: Won’t Work In Man. 3.After One Successful Clinical Patient: Very Lucky!4.After 4 or 5 Clinical Successes: Highly Experimental, Too Risky, Immoral Unethical. I Understand They’ve Had A Number Of Deaths They’re Not Reporting.5.After 10-15 Patients: May succeed Occasionally In Carefully Selected Cases, But Most Patients Don’t Need The Operation Anyway.
6.After A Large Series Of Success: So-and So In Shangri-La Has Been Unable To Duplicate Their Results. Not Practical. Only Experts Can Do It. I Hear That A Number Of Patients Are Now Dying Late Deaths.7.Final Stage: You Know, This Is A Very Fine Contribution! A Straightforward Solution To A Difficult Problem. In Fact, In 1929 I Had The Same Idea. Of Course We Did Not Publish Anything, Nor Did We Have Penicillin, Cortisone, And Fine Anesthesia In Those Days…
¨SAGES : Nashville Tn. : Pediatric panel¨Laparoscopic Nissen Fundoplication and G-tubesINDUSTRY EXPOSUREMET CURRENT THOUGHT LEADERS:Keith, Thom, Whit
3.5 mm, insulated, rotating Jarit
¨TENSILE STRENGTH¨DURABILITY¨INSULATED¨ROTICULATING¨WORKING HEADS¨TROCARS¨COST / PRACTICAL (No instrument can be bigger then the patient!)
¨Ist IPEG meeting in US¨First IPEG meeting for me¨First IPEG hands on lab¨First time to ask for industry support ¨First time to help coordinate an exhibit hall and Hands On Lab¨KEY TO UNDERSTANDING THE UNIQUE RELATIONSHIP BETWEEN IPEG AND INDUSTRY
¨Ethicon Endo-institute¨USSC training center¨Pediatric surgery courses : Memphis and then Miami (Lobe and Thompson) Forced to use large animals and 5 and 10mm instruments¨Yearly Fellows Course¨APSA/IPEG hands on courses¨UCSF MIS courses (Mike Harrison & Craig Albanese)
¨Ethicon Endo-institue¨USSC training center¨Pediatric surgery courses : Memphis and then Miami (Lobe and Thompson)¨IPEG hands on courses¨UCSF MIS courses
Intense 3 day courseIndustry engineers often presentOccurred every 4-6 monthsOccurred during a time of evolving techniques and proceduresWas fostered in the environment that developed fetal surgeryAccess to Engineers and marketing people
¨Short- 70mm¨3 mm reducer¨Non-slip
¨Short- 70mm¨3 mm reducer¨Non-slip
¨It was found that the sharp trocar control series was four (4.1) times more likely than the STEP ™ series to have a major device-related complication Rothenberg SS, Georgeson K, DeCou J et al: Clinical Evaluation of the Case of Radially Expandable Laparoscopic Access Devices in the Pediatric Population. Ped Endosurg Innovative Tech. (4); 7-11, 2000.
¨Scopes - 4mm and 3mm short (18-20cm) 0 & 30 degree¨Instruments: 3mm short¨Trocars: short 50-75mm
5mm Endoclip
IPEG Berlin April 1999
¨Expose pediatric surgeons to SAGES model: ideas, techniques¨Expose General surgeons to pediatric MIS¨To expose pediatric surgeons to industry and industry to pediatric surgery¨To keep me from going bankrupt¨SAGES key note lecture: Mini laparoscopy
STEVEN S ROTHENBERGTHE HOSPITAL FOR INFANTS AND CHILDREN AT P/SLDENVER, COLORADO
Rothenberg SS.: Thoracoscopic Closure of Patent Ductus Arteriosus in Infants and Children. Ped Endosurg Innovative Tech. (5); 109-112, 2001.
First decade's experience with3 thoracoscopic lobectomy in infants and children4 Steven S. Rothenberg⁎5 The Rocky Mountain Hospital for Children, Denver, CO 80111, USA J Ped Surg 20076 Received 28 August 2007; accepted 2 September 2007
¨USSC/Tyco/Covidien/Medtronic¨Ethicon¨Intuitive¨Storz¨Stryker¨Make it smaller, make it ergonomic¨Safely deal with vessels¨How to do an anastomosis without sewing¨Smaller versions of tissue staplers, clips, vessel sealing devices
The need to miniaturize was born!Single Site Surgery became a priority!
Rothenberg SS, Shipman K, Yoder S. Experience with modified single-port laparoscopic procedures in children. J Laparoendosc Adv Surg Tech A. 2009 Oct;19(5):695-8
M-PED
Inventor Support for Pediatric Innovation Biofilm destruction Eg. catheters & implantables Minimally Invasive NeurosurgicalTools Big Data AnalyticsEg. renal failure prevention Thrombus preventionEg. HD shunts, catheters, LVAD, Regional AnesthesiologyEg. nerve block catheters A multidisciplinary collaborative program to transform innovative pediatric medical device CONCEPTS into marketable PRODUCTS. Sanjeev Dutta, MD, Medical DirectorPablo Garcia, Technical Director
! "! #! A! B! C! D! E! FGHGI-KLMNO! P!4RSTUSVUV! ! ! ! ! ! ! ! ! WIF;L;44! KF;44YF;! 4;N4GF! ! ! ! ! ! ! ! ! -M=NM-G4I4! ! ! ! ! ! ! ! ! -M=NMK! ! ! ! ! ! ! ! ! >MOM!!LG==;F ! ! ! ! ! ! ! ! -M=N;OI?! -INI @-GA;F! B ACD!bcdeI! ! ! ! ! ! ! ! ! >gNM-I?! ?G-KF;44IGN! 4g4O;-! ! ! ! ! ! ! ! ! -M=NM=FM4K! !-M=N;OI?! F;OFM?OGF ! ! ! ! ! ! ! ! FGHGI-KLMNO! P!LUh i! TcdbMNcdUdb ! ! ! ! ! ! ! ! K;>IMOFI?! MFOIlI?IML! mI>N;g! ! ! ! ! ! ! ! ! WIF;L;44! Kng4I?ML! M?OIAIOg! -GNIOGF! !! ! ! ! ! ! ! N;GNMOML! ;?-G!>;AI?; ! ! ! ! ! ! ! ! MFOIlI?IML! KMN?F;M4 ! ! ! ! ! ! ! ! M-NIG4;ML ! ! ! ! ! ! ! ! 4-MFO! >;F -! ! ! ! ! ! ! ! WIF;L;44! KGW;F! OFMN4l;F ! ! ! ! ! ! ! ! ! Stages of Device Development:1 – Concept 2 – Prototype3 – Preclinical4 – Clinical5 – Manufacturing6 – Marketing7 – Commercial Use Progress of UCSF PDC Projects,2009 –2013
Magnetic Compression Anastomosis: Better, Faster, Cheaper&MAGIC Michael R. Harrison, MD
Novel device based on two ring-shaped rare earth magnets A-B. Magnets placed in structures to be joinedC. Magnets self-align D. Compression anastomosis produced by tissue remodeling
SZI Device Development Ecosystem(www.innovate4kids.org) SZI UMD-Clark Peter Kim MDMedical Director
¨Dear Dr. Rothenberg, We worked together several years ago on the LigaSure product when I was at Valleylab in Boulder. As I recall you were using the LigaSure Lap device because of the fine tips¨The group I am working for hasan interest in creating products specifically designed with the pediatric patient in mind. They would also like to take advantage of the NIH grants available for pediatric medial device development (#04-HD-102¨We are very committed to helping this venture group create products to meet your surgical needs. We would love to sit down and discuss your product needs to get our project off the ground.
¨Weekly design meetings¨Need survey with other surgeons (IPEG 2010)¨Animal test labs
Seed Money 2010 Sealer Feasibility BeginsStapler Feasibility Begins Round 1Funding 201120122013Round 2 FundingRound 3Funding Sealer FDA SubmissionSealer Development BeginsStapler Development Begins Sealer FDA Clearance Sealer 1st Human Use Stapler FDA Submission 3mm sealer system FDA 510K clearance May 20135mm stapler FDA 510K clearance February 2014 2014 Stapler 1st Human Use U.S. Launch @ APSA
¨Small, streamlined development team ¡operating with speed and efficiency.¨Strong leadership ¡2 past presidents of the world’s second largest surgical device company.¨Marketing success¡launched cutting edge technology resulting in incremental sales of $600 million annually.¨Engineering expertise¡Team are original inventors of revolutionary LigaSure™ sealing technology¨Patentable Intellectual Property¡3 unique patents¨Collaboration with surgeons
Wanted: Specialty Designed Tools for Pediatric Surgery"So we sort of struggle with instruments that were never designed for the type of patient that we're operating on, and we adapt… Really, I have to stand a foot-and-a-half away from the patient in order to just do the operation, because the instrument is so big,”Dr. Sanjeev Dutta– pediatric surgeon, Lucile Packard Children’s Hospital, Palo Alto, CA
Wanted: Specialty Designed Tools for Pediatric Surgery"So we sort of struggle with instruments that were never designed for the type of patient that we're operating on, and we adapt… Really, I have to stand a foot-and-a-half away from the patient in order to just do the operation, because the instrument is so big,”Dr. Sanjeev Dutta– pediatric surgeon, Lucile Packard Children’s Hospital, Palo Alto, CA
¨5.8 mm stapler ¨Ethicon 8mm stapler
¨Alternate energy sources¨3 mm clips¨Anastomotic device: U clips/stapler/ tissue fusion¨Neonatal Trainers
¨Alternate energy sources¨3 mm clips¨Anastomotic device: U clips/stapler/ tissue fusion (magnets)¨Neonatal Trainers
¨Surgeons¨Defined need¨New procedures¨Industry¨Business plan¨New technology IPEG Strength in Numbers/Worldwide Surgical Community
1.Idea Stage :No one needs it, Can’t be built. Materials don’t exist2.Successful Laboratory Design Tests: Can’t be duplicated in a production model, won’t work in humans3.After Successful Animal Trial: Very Lucky!, Can’t get funding, Can’t mass produce4.After 4 or 5 Clinical Successes: Highly Experimental, Too Expensive, Too many Failures. I Understand They’ve Had A Number Of Deaths They’re Not Reporting.5.After 10-15 Patients: May succeed Occasionally But unreliable, Hospitals won’t buy it, And Surgeons Don’t Really Need it,
6.After A Large Series Of Success: So-and So In Shangri-La Has Been Unable To Duplicate Their Results. Not Practical. Too Expensive, Only Experts Can USE It. 7.Final Stage: You Know, This Is A Very Fine Contribution! A Straightforward Solution To A Difficult Problem. We Had the Same Idea 20 Years Ago But The Market Just Didn’t Exist. There were no pediatric MIS surgeons at that time. Pediatric Instrumentation is a Great Advance not Only For Infants And Children, But For Adult Patients As Well
ThanksWilliam PokornyRaymond DonnellyJack ChangKarl Storz FamilyDave TemchulaJohn DavisDevon BreamEugene LucasRob EvansMy PartnersNeonatologists and Administration RMHCColumbia UniversityIPEG LeadershipBSC ManagementJust Right Surgical TeamMy Family
MAGNAMOSIS III: Delivery of a Magnetic Compression Anastomosis Device Using Minimally Invasive Endoscopic TechniquesKelly D. Gonzales MD, Geoffrey Douglas, MD, Kullada O. Pichakron, MD, Dillon A. Kwiat, BS, Salvador Guevara Gallardo, MD, Jose Luis Encinas, MD, Shinjiro Hirose MD, and Michael R. Harrison MD •Redesigned device to accommodate standard endoscopic snare•Endoscopic / Laparoscopic Delivery technique tested in 8 pigs•Duodeno-colic anastomosis well-healed at 1-6 weeks