dr. maarek eis & new technology
DESCRIPTION
Electrointerstitial scanTRANSCRIPT
LDTECHNOLOGYSYMPOSIUMCANCUN2008
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MedicaldevicesPosi.oningDiagnosis/Monitoring
• GENERALINFORMATION’S• ACCURACY
DIAGNOSISDEFINITION*
DiagnosisistheidenEficaEon,by
processofeliminaEon,ofthenatureofanything.
*Wikipedia
Processofelimina.oninmedicaldiagnosis
• Clinicalcontext:signs,symptoms,history,currenttreatments………………..
• SpecificExamina.ons:Medicaldevices
Imaging
InvitroLaboratorytests InvivoPhysiologicalmeasurements
.Physician’sKnowledgeandinterpreta.on
Medicaldevices
• features:ProvideIndicatorsnecessaryfortheprocessofelimina.onfordiagnosis
• Amedicaldevicedonotmakeadiagnosis,onlyaPhysiciancanmakeadiagnosis.
• Accordingtotheinves.ga.onsite,eachmedicaldeviceisprovidingspecificindicatorsinsameordifferentdirec.on.
• Thecrossanalysisofallindicatorsarenecessaryintheprocessofelimina.onfordiagnosisandinterpreta.onandknowledgeofthephysician
AccuracyoftheMedicaldevices
DependoftheSpecificityandSensi.vityoftheIndicatorsprovided.
Specificityandsensi.vity
Diagnosisarehypothesis
• AWertheprocessofelimina.on,thecrossanalysisoftheclinicalcontextandsupplementaryexamina.ons,thephysicianmakeahypothesisofdiagnosis:becausethehumanbodyisacomplexofbalanceandallthedysfunc.onsordiseaseshaveimplica.onsinallthebodysystems
TreatmentchoiceHypothesisofdiagnos.c
AdaptedTreatmentofthediagnoseddiseasesissuesfromtheclinicalinves.ga.ons
Improvementoftheclinicalcontext
Improvementoftheresultsofthesupplementaryexamina.ons
NoImprovementoftheresultsofthesupplementaryexamina.ons
OrImprovementornoimprovementofthe
clinicalcontext
MONITORING
Valida.onofthediagnosishypothesis
Novalida.on,misdiagnosisorno
responsesduestointerindividualdifference
Sideeffectoverthebenefitsofthetreatment
EISSYSTEMTECHNOLOGY
• FEATURES• BACKGROUND
EISMeasurement
EISSYSTEMFeatures:Impedanceplethysmography
1.Measurementoftheconduc.vityinDC*of22segmentsofthehumanbody.
*Theconduc.vityinDC(wayfromanode(+)tocathode(‐))ispropor.onalwiththe:
I.S.Fvolume I.S.FIonicconcentra.onandinpar.culartheNa+concentra.on BloodflowConduc.vitymeasurementaccuracy+/‐3.5%2.Modeling**oftheHumanbodyaccordingtotheconduc.vityofthe
22segmentsbymathema.calapplica.onoftheVenndiagramandthenormalposi.oningextrapola.onofthebodysystems.
**Accuracyofthemodeling(p<0.001)forthecerebralfrontallobes,diges.vesystemProstateandthyroid.
EISFeatures
Sequenceofthemeasurementofthe22bodysegments
ESGgraphic:conduc.vityofthe22segments
ESGnormalrangevalues
EISFeatures(2)
Venndiagramcalcula.on
Maxwellequa.on’scalcula.onModeling
CONDUCTIVITY
Min
Max
Thecurrentiscarrierbytheions.TheCurrentissendingfromtheAnode(+)toCathode(‐),andthereforetheNa+(mostsignificantconcentraEonofposiEveionsintheIF)aremovingtothenegaEvepole.
TheconducEvityisproporEonallyincreasedwiththeNa+concentraEonandthevolumeoftheintersEEalfluid
1.28V
EIS/EFFECTOFTHEDCCURRENTININTERSTITIALFLUID
Na+/K+pumpNa+/H+an.porterNa+/ATPProduc.on
Na+
Na+Na+
Na+Na+
Na+Na+ Na+ Na+H+
ATP
IntersEEalfluidvolumeandOxygendelivery
EffectofintercapillarydistanceonrelaEonbetweenoxygendeliveryBMJ.1998November14;317(7169):1370–1373.
Copyright©1998,BriEshMedicalJournal
EISMODELINGPARAMETERS
• I.SFvolume
RelatedwiththeOxygendeliveryandosmo.c/hydrosta.cpressure
• I.SF[Na+]Relatedwith[K+](2/3),[H+]andATPproduc.on.
• BloodflowRelatedwiththeBloodviscosityandtheBloodvelocity.
EIS–BFSYSTEM
• CLINICALINVESTIGATIONS
• UPDATEVERSION10
EIS‐BFClinicalInves.ga.ons
AccuracyforMonitoringofthefollowingtreatment(p<0.001):Sp94%Nosensi.vity
• Thyroidsubs.tutetreatment
• Hypotensors(BetablockersandCEI)• An.coagulants• An.depressantsSSRIAccuracyinAdjunctinconven.onaldiagnosisoftheADHDchildren:(p<0.0001):
Sp95%/Se78%
Visit1:NotreatmentVisit2:Dosage100µgVisit3:Dosage120µgVisit4:Dosage150µgVisit5:Dosage100µg
Visit1:‐40Visit2:‐10Visit3:0Visit4:+20Visit5:‐5
Visit1Visit2:6Visit3:3Visit4:0Visit5:2
ThyroidvalueinEISModeling
TSHmeasuredinlabtests
N=52(r=0.79,P<0.001,
andr=0.80,P<0.001,respec.vely).
N=52(r=0.81,P<0.001,
andr=0.73,P<0.001,respec.vely).
N=52(r=0.79,P<0.001,andr=0.80,P<0.001,).
N=52(r=0.79,P<0.001,andr=0.80,P<0.001,).
N=52
(r=0.79,P<0.001,andr=0.80,P<0.001,).
N=52
(r=0.79,P<0.001,andr=0.80,P<0.001,).
N=52
(r=0.79,P<0.001,andr=0.80,P<0.001,).
N=52
(r=0.79,P<0.001,andr=0.80,P<0.001,).
ADHDChildrenProfile
EISBFResultsVersion10
Diges.vesystemIndicators
BrainIndicators
CardiovascularIndicators
HORMONALINDICATORS
RESPIRATORYINDICATORS
Generalmetabolicindicators
Urogenitalandrenalindicators
Followupofalltheindicators
Medica.onsmonitoringindicators
An.depressant(SSRI)Followup
Beforetreatment Response
Noresponse
FollowupoftheCerebralneurotransmirers
Medica.onsmonitoringindicators
Followupofthyroidtreatment
Beforetreatment Monitoringandresults
Overdoses Underdoses
Medica.onsmonitoringindicators
An.agregantsandan.coagulantsfollowup
Beforetreatment Effec.vetreatment
Noeffec.ve
Medica.onsmonitoringindicators
Betablockersfollowup
Beforetreatment Noeffec.vetreatment
Overdosisandsideeffects Goodtreatment
CEIFollowup
Beforetreatment Goodtreatment
Overdoseandsideeffect Noeffec.ve
ADHDChildrenprofileanddiagnosisinadjunctwiththeclinicalcontext
IndicatorofADHDChildren
LackDopamineandSerotoninandsignsandsymptomsfromclinicalcontextchildrenless17y.o
EISPOSITIONING
• QUALITYSYSTEMINMEDECINE
EISSystem:Maybeapossibilityforhelpthequalitysystemrequirementsinmedicine
Posi.oningoftheEISintheQualitySystemRequirements
Riskmanagement/
PaEent'compliance Pa.ent'needs
Consulta.on
Supplementaryexamina.ons
Diagnos.csTreatments
Control
Correc.veac.ons
Control
EISSYSTEM
WhyaqualitysystemwiththeEISSystem
• Noinvasive,quick,usability,Lowcost• Forthepa.ent:Understandingofthetreatmentandgoalofthetreatment
• Fortheprac..onerEarlyvisualiza.onofthetherapiesandearlypossibilityofcorrec.veac.on
• Becauseadiseasetreatmentrequiresdrug,some.mesurgeryandalwayslifestylechange
• Because,themajordiseasescannotbetreatedbylifestylechangeoralterna.vemedicine.
Benefitsofthequalitysysteminmedicine
• Forthepa.ent:Visualiza.on/mo.va.on/compliance• Fortheprac..oner: Organiza.on,save.me Bererunderstandingoftheintendeduseandsideeffectsofthetreatmentsused
Correc.veac.onsthatthepa.entcanunderstand Referrals Incomeincreased
NEWPRODUCTS
• WHY?
Newproducts
• EIS• BWS:Wellnessandlifestyle
• ESTeck:Es.matedoftheANSac.vityandofcardiovascularindicators.510kinprogress
NrK083229
• ESTeckComplex:Combina.onEIS/ESTeck
EISNewapplica.on:BSW(BodyScanWellness)
• WhyBSW?Because
Thereisnotgoodorbaddietforeverypeople,thereisgoodorbaddietforeachperson
Thechangeofnutri.onneedtobemonitoringandthegoodnutri.onforeachpersonisnotavailableallhislife.
BasedontheEISandBCdevicemeasurement
WhytheESTeck
• BecauseHRV(ANSac.vityes.ma.on)
PhotoelectricalPlethysmograph(Vasculares.ma.on)
bodycomposi.onandthephaseAnglemeasurement
Cangivenewindicatorsintheprocessofelimina.onofthephysician’sdiagnosis
WhytheESTeckComplex
Combina.onoftheEISandtheESTeck:Because:
Thecrossanalysisoftheindicatorsissuefrom4differenttechnologieswillincreasethesensi.vityandthereforetheaccuracyofamedicaldevice
BODYSCANWELLNESS
• Newapplica.onoftheEISTechnology
BWSMeasurement
BSWResults
BodyComposi.on
NutriEonalandmicronutrionalprogramAnalysis
Bodycomposi.on
BMI
AcidbaseConduc.vity
Nutri3onalAnalysisReport
Allresultsshouldbeconsideredintheclinicalcontextofthepa3ent'scasehistory,symptoms,knowndiagnosis,currentmedica3ons,treatmentplanandtherapies.Thisdietanalysisdoesnotreplacetheadviceofyourprac33oner.
Thees3matedbodycomposi3onismadeaccordingtotheJamesequa3onandtheformulasfromthepeerreviews.
Nutri.onalAnalysisReport(2)
BodyComposi.onFollowup
ESTECKSYSTEM
• GENERALINFORMATION’S
ESTeckSystem(Cardiology)
• HRVPhotoelectricalPlethysmograph
HRV(short.me)
HRVReference:
TaskForceofTheEuropeanSocietyofCardiologyandTheNorthAmericanSocietyofPacingandElectrophysiology(1996)
SpO2andPhotoelectricalPlethysmograph
References:• NicholsWW,O’RourkeMF.McDonald’s:BloodFlowinArteries:Theore.cal,
ExperimentalandClinicalPrinciples.London:Arnold,1998.• Takazawa,Kenji;Tanaka,Nobuhiro;Fujita,Masami;Matsuoka,Osamu;Saiki,
Tokuyu;Aikawa,Masaru;Tamura,Sinobu;Ibukiyama,Chiharu:AssessmentofVasoac.veAgentsandVascularAgingbytheSecondDeriva.veofPhotoplethysmogramWaveformHypertension:Volume32(2)August1998pp365‐370
• IToshiakiOTSUKA,TomoyukiKAWADA,MasaoKATSUMATA,ChikaoIBUKI,andYoshikiKUSAMAndependentDeterminantsofSecondDeriva.veoftheFingerPhotoplethysmogramamongVariousCardiovascularRiskFactorsinMiddle‐AgedMenHypertensResVol.30,No.12(2007)
• ToshiakiOtsuka,,TomoyukiKawada,MasaoKatsumata,ChikaoIbuki,:U.lityofSecondDeriva.veoftheFingerPhotoplethysmogramfortheEs.ma.onoftheRiskofCoronaryHeartDiseaseintheGeneralPopula.onCircJ2006;70:304–310
• AlbertoAvolio:Thefingervolumepulseandassessmentofarterialproper.es.JournalofHypertension2002,20:2341–2343
• OximeterGuidelines1998
ESTeckMeasurements
HeartRateandsinusnodedepolarizaEon
AutonomicNervousSystemandHeartratevariability
SpO2ANDPhotoelectricalPlethysmography
SpO2Probe
Infrared/Red 660/905nm
Photodiode
SpO2%
PR
Vascularwaves
SpO2ANALYSIS
Oxygen‐hemoglobinAffinityChanges.
Thefunc.onsofhemoglobinareoxygenpickupanddelivery.Thehemoglobinhasanaffinity(thestrengthofbondbetweenoxygenandhemoglobin)thatcanbeincreasedordecreasedduetovarioussitua.ons.Ifhemoglobinhasanincreasedaffinity,itishighlysaturated;butoxygenislessavailableforreleasetothe.ssuesduetothestrongbond.Thereverseisalsotrue.
VascularWaveAnalysis
AnalysisbyAccelera.onandSecondderiva.ve
AnalysisoftheSecondderiva.vewithage
Analysisofthesecondderiva.veanddiseases:b/a
Analysisofthesecondderiva.veanddiseases:d/a
Specificityandsensi.vityoftheb/aandd/aindicators
Specificityandsensi.vityoftheb/aandd/aindicators
Ref.ToshiakiOTSUKA,TomoyukiKAWADA,MasaoKATSUMATA,ChikaoIBUKI,andYoshikiKUSAMAIndependentDeterminantsofSecondDeriva.veoftheFingerPhotoplethysmogramamongVariousCardiovascularRiskFactorsinMiddle‐AgedMenHypertensResVol.30,No.12(2007)
ResultsofESTeck
HRVSTATISTICALRESULTS
SpO2andPhotoelectricalPlethysmographresults
E.STECKCOMPLEX
• GENERALINFORMATION’S
ESTECKCOMPLEXTHENATURALEISUPDATE
ESTeckComplexMeasurements
CROSSANALYSIS
Cross
Analysis
EIS
HRV
SpO2/PP
BIA
• HRVmodule:ToanalyzethebasicrhythmsoftheNNorRRintervalsinelectrocardiograms,bothinthe.medomainandinthefrequencydomain(short.me5minutes)
• Itonlyprovidesnumericalanalysesoftheinputelectrocardiogram.• EsEmateoftheparasympatheEcandsympatheEcsystem
sEmulaEon.• PPmodule:Analyzethepulsewaveformbyphotoelectric
plethysmographyandPulserate.• EvaluaEonofLargeandsmallartery
• EISmodule:• Monitoringofdiseases,funcEonalandlifestyle‘treatments
• AdjuncttoconvenEonaldiagnosisofADHDchildren• BIAmodule:• CalculaEonandHistoricalTrackingofbodycomposiEon
E.STECKCOMPLEXINTENDEDUSES
BodyImpedanceAnalysis(BIA)MeasurementoftheResistanceandReactanceinTetrapolarmodewithafrequencyof50
KHz
ResistanceandReactancemeasurements
• Resistanceisameasureofhowdifficultitisforelectricitytoflowthroughanobject.
• ReactanceMostobjectshavesomecapacitance,whichisameasureofabilitytostoreanelectricalcharge.Themorecapacitancetheobjecthas,orthefasterthecurrentchangesdirec.on,thelesstheobjectwill“react”tothecurrent.
EISBIA
Peerreviewsformula• TotalBodyWater:TWB5‐19y.oDaviesetal198820‐80y.oLukaskiandBolonchuk1988Adultobesesubjects:Segaletal1988• Fatfreefatmass:7‐15y.oDeurenbergetal199116‐83y.oDeurenbergetal1991• Extracellularwatervolume:EWCSergiG,etal1994
PhaseAngle
ImpedanceComponents
Phase Angle
Xc = 1 / (2 * PI * F * C), C – Capacity [Farad]
Phase Angle = Arctan (Xc / R)
Clinicalapplica.oninsurvivalincolorectalcancer
Thesurvivalcurvesforthe2categoriesofphaseangleareshown.Pa.entswithaphaseangle<5.57
hadamediansurvivalof8.6mo(95%CI:4.8,12.4;n=26),andthosewith
aphaseangle>5.57hadamediansurvivalof40.4mo(95%CI:21.9,58.8;n=26);thisdifferencewas
significant(P=0.0001).
Impactofphaseangleinlivercirrhosis
NEWINTERFACE
E.STECKRESULTS
EISANALYSIS
HRVSTATISTICALRESULTS
HRVRECORDS
HRVGEOMETRICALANALYSIS
SpO2RESULTSANDMANAGEMENTOFTHEPHOTOELECTRICALWAVE
PHOTOELECTRICALPLETHYSMOGRAPHANALYSISANDRESULTS
VascularIndicators
• PH:Rela.onwithbloodflowofsmallartery• EEI:Rela.onwithLVejec.onandelas.cityoflargeartery‐LVEjec.onInsufficiency
• DDI:Rela.onwithcontrac.onandtensionofsmallartery‐Hypertension&Arteriosclerosis
• DEI:Rela.onwithbloodflowtoveinsystem.
• Etc(Es.matedCardiacEjec.on.me):260~380Func.onofleWventricle
BODYCOMPOSITIONRESULTS
BodyComposi.onfollowup
E.STECKCOMPLEX
• CROSSANALYSIS• MODELINGANDBODYSYSTEMS’INDICATORS
DIGESTIVESYSTEMINDICATORS
BRAININDICATORS
CARDIOVASCULARINDICATORS
HORMONALINDICATORS
RESPIRATORYSYSTEMINDICATORS
GENERALMETABOLICINDICATORS
UROGENITALANDRENALINDICATORS
Followupofalltheindicators
FollowupoftheCerebralneurotransmirers
Medica.onsmonitoringindicators
Medica.onsmonitoringindicators
Medica.onsmonitoringindicators
Medica.onsmonitoringindicators
ADHDChildrenprofileanddiagnosisinadjunctwiththeclinicalcontext
ChiropractorIndicatorsandmonitoringtreatment
AdvicesforLifestyleandexercisesandmonitoring
AdvicesforLifestyleandexercisesandmonitoring
AdvicesforLifestyleandexercisesandmonitoring
Exercises
Sportmencondi.onEvalua.onandimprovement
Sta.s.calriskanalysis
• Noaccessbefore5measurements.Theaccuracyincreasedwiththenumberofmeasurements.
• Sta.s.calanalysisoftheindicatorsofeachbodysystemsandmetabolicgeneralindicators
• Itisnotadiagnosis,buthelpforthephysicianintheprocessofelimina.on
TECHNICALSUPPORT
RemoteTechnicalSupportAssistance
RemoteTechnicalSupportAssistance
Installa.onproblems
N DescripEonormessage SoluEon
1 Windowscan’tfindUSBdeviceDriver
ReadUser’smanualandinstalldriver’saccordingtoinstruc.onstepbystep,CallTechnicalSupportAssistance
SoWwareproblems
N DescripEonormessage SoluEon1 GDIError ReinstallEISsoWware2 VisualC++Run.meerror…on
3DimageInstallnewGraphicDriver
3 VersionOpenGLlessthen1.2 InstallnewGraphicDriver4 EISSoWwareworksveryslowly Switchcomputer’sPower
Op.ontoHighPerformance5 LoginorPasswordisincorrect CallTechnicalSupport
Assistance6 SoWwarerequiresanewPIN
codeCallTechnicalSupportAssistance
7 RightorLeWElectrodeisnotconnectedduringscanprocess..
SeeHardwareProblems
HardwareproblemsN DescripEonormessage SoluEon1 Deviceisdisconnected… CheckDriver’sinstalla.oninDevice
Manager,ReconnectUSBcable,restartthecomputer
2 ChannelsTestorPowerTestisnotOK 1.Disconnectthecablesforelectrodesfromdevice,makethetestagain
3 ChannelsTestorPowerTestisnotOK 2.CheckthedeviceisconnecteddirectlytoUSBportandtherearenotanyUSBHUBs
4 ChannelsTestorPowerTestisnotOK 3.CallTechnicalSupportAssistance5 RightorLeWElectrodeisdisconnectedduring
scanandsomevolumesareverylow(‐100)1.Checkandremovefilmprotec.onfromelectrode’ssurface
6 RightorLeWElectrodeisdisconnectedduringscanandsomevolumesareverylow(‐100)
2.Makecable’stest,Connec.onWizardTest,Disconnectallcablesandconnectagain
7 RightorLeWElectrodeisdisconnectedduringscanandsomevolumesareverylow(‐100)
3.CallTechnicalSupportAssistance
ContractofMaintenanceFreethefirstyear
AndthenUS$500/YearIfnomaintenancecontract:
Updateprice:US$400Eachtechnicalsupportinterven.on:US$80