LVI TECHNOLOGY • LVI catheter enables real-time, three-dimensional (4D) visualization for intracardiac surgeries • Provides instantaneous, full-volume views at the point of surgery, with greater field-of-view and continuous imaging of the dynamic anatomic environment • Existing intracardiac echo (ICE) catheters produce only two- dimensional images, limiting surgeon’s field-of-view ENVISIONED APPLICATION • Pulmonary vein ablation • Atrial fibrillation affects over 5 million people • 75,000 procedures per year in U.S. • Failure rate >30% due in part to inadequate image guidance, leading to under ablation • LVI can potentially increase efficacy by providing a continuous intracardiac view of the catheter tip • LVI can potentially reduce injury by providing better, continuous views of adjacent anatomy BREAKTHROUGH TRANSDUCER TECHNOLOGY • MEMS-based Matrix Phased Array transducer – 256-512 elements for 4D imaging – Semiconductor processing for manufacturability and miniaturization – No cutting and assembly of piezoceramic plates – Transducer arrays produced in batches of silicon wafers • Novel cable assemblies integrated using semiconductor packaging and interconnection technologies RECENT PROGRESS • Demonstrated real-time 3D imaging from 5 to 12.5 MHz, ideally suited for intracardiac imaging • Fabricated operational 14F intracardiac catheter prototypes and completed initial in vivo animal imaging experiments LVI Performance Meets User Needs Technology LVI ICE Mechanical 4D ICE 1 3D TEE 2 Volume sector 60° x 60° (up to 80° x 80°) 60° x 90° 60° x 60° (up to 90° x 90°) Scan depth 8-10 cm 6 cm >10 cm Frame rate 25-30 vol/s 6 vol/s 7-10 vol/s Resolution 1 mm (40 mm depth) good good Transducer cost $ $$ $$$ 1 Lee et al. (2010) Proc. IEEE IUS: 833 2 Faletra et al. (2012) Circ. J. 76:5 EXPECTED BENEFITS • Fewer complications—Improved visibility of moving anatomy • Efficient imaging—Real-time data capture, full-volume views that can be manipulated to change vantage point • More patients—Reduced procedure/exam time • Better outcomes—Shorter, more accurate procedures ICE CATHETER PROTOTYPE • Real-time, volumetric imaging • Matrix phased array • 14F, side-looking • 5 MHz • Steerable • 35” working length REFERENCES D. E. Dausch, J. B. Castellucci, K. H. Gilchrist, J. R. Carlson, D. R. Chou, and O. T. von Ramm, 2010. “Improved Pulse-Echo Imaging Performance for Flexure- Mode pMUT Arrays,” Proc. IEEE Ultrasonics Symposium: 451-454 D. E. Dausch, J. B. Castellucci, D. R. Chou, and O. T. von Ramm, 2008. “eory and Operation of 2D Array Piezoelectric Micromachined Ultrasound Transducers,” IEEE Transactions on Ultrasonics, Ferroelectrics and Frequency Control 55(11): 2484–2492 U.S. Patent 7,449,821, US2010/0168583, WO2011/094393, WO2011/139602 ACKNOWLEDGMENT e authors thank Professor Olaf von Ramm and Mr. John Castellucci of Duke University for their assistance in device testing and real-time 3D ultrasound imaging. MORE INFORMATION David E. Dausch, PhD Lynn M. Soby, PhD Senior Research Engineer V.P., Commercialization 919.248.1412 919.541.8836 [email protected] [email protected] RTI International 3040 Cornwallis Rd., Research Triangle Park, NC 27709 SEE THE DIFFERENCE. Live Volumetric Imaging (LVI) Catheter for Intracardiac Echo (ICE) David E. Dausch, PhD, Lynn M. Soby, PhD • RTI International, Research Triangle Park, NC Concept for live volumetric image guidance during intracardiac pulmonary vein ablation RTI International is a trade name of Research Triangle Institute. Real-time volume scan of a metal spring and finger tips in a water tank using a 512-element pMUT matrix phased array (60° x 60° volume, 3 mm x 6 mm array, 5.6 MHz) Matrix Phased Array Piezoelectric Micromachined Ultrasound Transducer (pMUT) integrated with catheter cable assembly LVI Prototype ICE Catheter February, 2013 Best Sufficient Poor
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LVI TechnoLogy• LVIcatheterenablesreal-time,three-dimensional(4D)
visualizationforintracardiacsurgeries
• Providesinstantaneous, full-volume viewsatthepointofsurgery,withgreaterfield-of-viewandcontinuousimagingofthedynamicanatomicenvironment
• Existingintracardiacecho(ICE)cathetersproduceonlytwo-dimensionalimages,limitingsurgeon’sfield-of-view
enVIsIoned AppLIcATIon• Pulmonaryveinablation
• Atrialfibrillationaffectsover5millionpeople
• 75,000proceduresperyearinU.S.
• Failurerate>30%dueinparttoinadequateimageguidance,leadingtounderablation
• LVIcanpotentiallyincrease efficacybyprovidingacontinuousintracardiacviewofthecathetertip
• LVIcanpotentiallyreduce injurybyprovidingbetter,continuousviewsofadjacentanatomy
BreAkThrough TrAnsducer TechnoLogy• MEMS-basedMatrixPhasedArraytransducer
– 256-512elementsfor4Dimaging
– Semiconductorprocessingformanufacturabilityandminiaturization
– Nocuttingandassemblyofpiezoceramicplates
– Transducerarraysproducedinbatchesofsiliconwafers
• Novelcableassembliesintegratedusingsemiconductorpackagingandinterconnectiontechnologies
recenT progress• Demonstratedreal-time3Dimagingfrom5to12.5MHz,ideallysuitedfor
intracardiacimaging
• Fabricatedoperational14Fintracardiaccatheterprototypesandcompletedinitialin vivoanimalimagingexperiments
LVI Performance Meets User Needs
Technology LVI ICE Mechanical 4D ICE1 3D TEE2
Volume sector60° x 60°
(up to 80° x 80°)60° x 90°
60° x 60° (up to 90° x 90°)
Scan depth 8-10 cm 6 cm >10 cm
Frame rate 25-30 vol/s 6 vol/s 7-10 vol/s
Resolution1 mm
(40 mm depth)good good
Transducer cost $ $$ $$$1 Lee et al. (2010) Proc. IEEE IUS: 8332 Faletra et al. (2012) Circ. J. 76:5
expecTed BenefITs• Fewer complications—Improvedvisibilityofmovinganatomy
• Efficient imaging—Real-timedatacapture,full-volumeviewsthatcanbemanipulatedtochangevantagepoint
• More patients—Reducedprocedure/examtime
• Better outcomes—Shorter,moreaccurateprocedures
Ice cATheTer proToType• Real-time,volumetricimaging
• Matrixphasedarray
• 14F,side-looking
• 5MHz
• Steerable
• 35”workinglength
referencesD.E.Dausch,J.B.Castellucci,K.H.Gilchrist,J.R.Carlson,D.R.Chou,
andO.T.vonRamm,2010.“ImprovedPulse-EchoImagingPerformanceforFlexure-ModepMUTArrays,”Proc.IEEE Ultrasonics Symposium:451-454
D.E.Dausch,J.B.Castellucci,D.R.Chou,andO.T.vonRamm,2008.“TheoryandOperationof2DArrayPiezoelectricMicromachinedUltrasoundTransducers,”IEEE Transactions on Ultrasonics, Ferroelectrics and Frequency Control 55(11):2484–2492
U.S.Patent7,449,821,US2010/0168583,WO2011/094393,WO2011/139602
AcknowLedgmenTTheauthorsthankProfessorOlafvonRammandMr.JohnCastellucciofDukeUniversityfortheirassistanceindevicetestingandreal-time3Dultrasoundimaging.
more InformATIonDavidE.Dausch,PhD LynnM.Soby,PhDSeniorResearchEngineer V.P.,Commercialization919.248.1412 [email protected] [email protected]
RTI International3040CornwallisRd.,ResearchTrianglePark,NC27709
See the difference.
Live Volumetric Imaging (LVI) Catheter for Intracardiac Echo (ICE)David E. Dausch, PhD, Lynn M. Soby, PhD • RTI International, Research Triangle Park, NC
Concept for live volumetric image guidance during intracardiac pulmonary vein ablation
RTIInternationalisatradenameofResearchTriangleInstitute.
Real-time volume scan of a metal spring and finger tips in a water tank using a 512-element pMUT matrix phased array (60° x 60° volume, 3 mm x 6 mm array, 5.6 MHz)
Matrix Phased Array Piezoelectric Micromachined Ultrasound Transducer (pMUT) integrated with catheter cable assembly
LVI Prototype ICE Catheter
February,2013
BestSufficientPoor
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