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 919.541.8836dausch@rti.org lsoby@rti.org

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