1

ALookInsideaDevicethatLooksInsideYou
The3ChipEndoscopicCamera

DanaDrage,AlexHoyle,JakobKillin,AveryMaddox,TaylorOldigesandAustinWanek
UniversityofCincinnati:BME2000
Cincinnati,Ohio
dragedm@mail.uc.edu
,
hoyleaj@mail.uc.edu
,
killinjk@mail.uc.edu
,
maddoxay@mail.uc.edu
oldigetl@mail.uc.edu
,
wanekam@mail.uc.edu

Abstract:Thispaperpresentstheuses,technology,anddevelopmentsbehindthe3Dimensional
EndoscopicCamera,madebyStrykerCorporation.Itaimstodetailthebenefits,aswellas
problems,withthedeviceasseenbyanengineer.

I.

ClinicalNeed
Endoscopyisabroadfieldwithmanydifferentapplications,butcanbemorenarrowly

definedasamedicalprocedurethatexaminestheinteriorofthebodyusinganendoscope.An
endoscopeisamedicaldevicebuiltofalong,thintubewhichhasalightandavideocamera
[10].Inotherwords,endoscopyisaminimallyinvasivetechniquethatallowssurgeonstolook
insideofpeoplewithouttheneedforlargeincisions.Doctorswillcommonlyuseendoscopesto
confirmdiagnoses,performbiopsies,andaidinsurgery.Anendoscopecanbefittedwithother
surgicalinstrumentstoperformmorespecificfunctionsduringsurgeries.Endoscopescanhave
alternativefunctionsdependentuponwhatareaofthebodytheyareusedtoexamine,asthereare
sixdifferentspecializedtypes,someofwhichincludecolonoscopes,gastroscopes,
hysteroscopes,andarthroscopes.Inadditiontothedifferenttypesofendoscopes,thereare
fourteendifferenttypesofendoscopicprocedures,includingbronchoscopy,colonoscopy,and
laparoscopy,amongothers[10].Justasthedifferenttypesofendoscopesarenamedafterthe

areasthattheyinvestigate,thedifferentendoscopiesaredifferentiatedbytheareaofthebody
thatisbeinginvestigated.Thedeviceexaminedinthispaper,the1488HD3ChipEndoscopic
CamerabyStrykerEndoscopy,isusedforlaparoscopy,nasopharyngoscopy,earendoscopyand
someplasticsurgeryendoscopy[17].Thatbeingsaid,themarketforendoscopesisbroadand
becomingmorediverse.
Endoscopyhasbeenarapidlygrowingfieldinrecentyears.In2010,around51.43
millionendoscopieswereperformedintheUnitedStates[3].Inthesameyear,aroundnine
percentofsurgeryroomshadbeendesignatedforendoscopyandtwentysevenpercentof
singlespecialtysurgerycentersweredrivenbygastroenterologyprocedures,whichisonlyone
medicalspecialtythatusesthetechnique[15].Becauseofthis,endoscopicproceduresplayeda
significantroleinthemedicalandsurgicalfieldsandtheamountofendoscopiesandendoscopic
continuestodrasticallyincrease.Inanarticlediscussingthegrowthofendoscopy,theoverall
marketforendoscopesispredictedtogrowatacompoundannualgrowthrateof6.8%from
2013to2019.Extrapolatingthisdatatotheperiodfrom2010tothepresent,thefieldhasgrown
immensely.
Strykerhasrecognizedthesizeofthemarketandhasdevelopedaseriesofendoscopes,
ofwhichthe1488HD3ChipEndoscopicCameraisthenewestmodel.Someofthefeaturesof
the1488HDincludeahighqualityvideodisplayandCMOStechnology,standardizationwith
thedifferenttypesofendoscopies,andplatformintegrationwithdifferentsurgicalsuite
manufacturers[17].Whiledesigningtheproduct,designershadtotakeintoaccountsterilization,
mobilityofthedevice,basicdesignandsizeofthecamera,easeofaccessofthedevice,impact
onthepatient,resolutionversussize,andcostofmaintenance.Inadditiontotheconstraints

listedbefore,thebasicissuessurroundingendoscopymustbecovered,suchasgainingsufficient
lighting,compatibilitywithothersurgicaldevicesandmonitoringequipment,andeaseofusefor
thesurgeon.
Inrecentyears,therehasbeenapushtoinnovatelessinvasivesurgeries,spearheadedby
theendoscope.Forthesurgeontobeabletovisualizetissuesinsidethebody,theremustbea
videofeedforthedoctortoview.Tobeabletousethevideofeed,theaforementionedlightmust
beincludedsothatthevideofeedcanbeseen,astheinsideofapersonisunlit.Thecross
compatibilityoftheendoscopealsoallowsthedevicetobeusedinmanydifferentapplications
andenvironments.Allthingsconsidered,the1488HDCamerastrivestocreatea
crosscompatibleplatformfordoctorstouseinendoscopiesthatfulfillthehighstandardsofthe
medicalfield,allwhileworkingtominimizepatientpain.

II.

Constraints
Severalconstraintsexistinthedesignofanendoscopiccamera.Theoveralleffectof

theseconstraintsisthatthedevicemustbepracticaltousefortheclinicianandsafeforthe
patient.Someofthemajorconstraintstowardsthisendarethesterilizability,size,heat
production,mobility,andeaseofuse.

Sterilizabilityisanimportantconstraintofendoscopiccameradesign.Anendoscopic
camerawillnotbesafeforthepatientifitpresentsasignificantriskofcausinganinfection.The
possibilityofinfectionisstilloneofthemainsafetyrisksforthepatientwhenconsideringan
endoscopicprocedure[19].Inordertoreducethisrisk,anendoscopiccameramustbedesigned

insuchawaythatitcanbesterilizedorhighlydisinfectedwithoutdamagingthedevice[8].Both
sterilizationandhighleveldisinfectioneliminatebacteria,fungi,viruses,andparasites.
However,onlysterilizationreliablyeliminatesbacterialendospores.Itisbecauseofthisthatthe
deviceshouldbedesignedtowithstandthesterilizationprocedures,whichincludesteam,
ethyleneoxide,orperaceticacid.Tomeetthisconstraint,thedeviceshouldalsobeabletobe
dismantledsothataccumulatedbioburdencanberemovedfromthedevice[8].
Anotherconstraintisthemobilityofthedevice.Thisreferstotheabilitytoinsert,
remove,andmaneuverthedevicewithinthepatientwithoutcausingharm.Thisisimportant
becauseoneofthemainrisksassociatedwithendoscopicproceduresistheperforationofthe
liningsoftheorificewherethecameraispresent[19].Tomeetthisconstraint,thedevicemust
bedesignedwithoutsharpedges.Also,thedeviceshouldbecontrollabletosuchadegreethatit
isnotmadetocomeintoforcefulcontactwithorificelinings.Tomeetthisconstraint,ahandheld
controllerprovidesup/downorleft/rightcontrolofthetipoftheendoscopeshaftasitis
maneuveredinthepatient[18].
Sizeisyetanotherconstraintinthedesignoftheendoscopiccamera.Theendoscopic
cameraisusedtoanalyzesmallpassagewayssuchasthemouth,throat,nasalcavity,andcolon.
Othersurgicaltoolscanalsobepresentintheorificealongwiththeendoscopiccamera,thus
furtherlimitingtheavailablespace.Theendoscopiccamerashaftmustbedesignedtobeasize
thatwillnotsignificantlyinterferewiththeabilitytomaneuverothertoolsorthecameraitself.
Sizeisalsoaconstrainttopreventexcessivediscomforttothepatientastheendoscopeis
inserted.Tomeetthisneed,themainshaftofendoscopes,includingthe1488HD,aretypically
about10millimetersindiameter.

Limitedheatproductionisanotherconstraintinthedesignofanendoscopiccamera.The
lightinginendoscopiccamerasproducesconsiderableheatandasthewattageofthelightingin
thecameraincreasessodoesthepotentialforthecameratoburnthepatient[7].Drapesand
towelsonlyprovidelimitedprotectionagainstthesedrapeburns,soitisstillimportantthatthe
cameradoesnotproduceenoughheatforthistobeaconcern.TheL9000LEDlightsourceused
inthe1488HD3chipcameraisdesignedtoproducelessheatduringproceduresand
automaticallyenterstandbymodeifthelightcablebecomesdetachedandexposestheheated
lightsource[18].
Finally,thedesignofanendoscopiccameraisalsolimitedbyitseaseofuse.Theeaseof
usecanbemeasuredusingthetimeittakestocompleteataskwiththeendoscope.Another
measurementforeaseofuseincludesthenumberoftimethetipcollideswithanorificesurface
[9].Theparticipantsintestingtheprocesscanalsogivetheirgeneralimpressionasaninitial
measurementofeaseofuse[9].The1488HD3chipcameraincludesfeaturestomeetthis
constraintincludingfourprogrammablebuttonstopersonalizecontroloftheendoscopeandan
optionalpneumaticstabilizertoholdthecontrollermorestable[18].

III.

HowitWorks
The1488HD3chipendoscopiccamerautilizesmultipleinnovativetechnologiesto

performitsfunction,includinginfraredtechnologyandanadvancedCMOS(complementary
metaloxidesemiconductor)chip.Inadditiontoitstechnologicalfeatures,thisdevicealsois
compatiblewithotherStrykerproducts,includingtheWingmanPneumaticScopeHolderand
L9000LEDLightSource[17].

Inorderforanendoscopetowork,theendoscope,thecamera,andtheimagingdevice
mustallhavetheappropriateparameters,whichdependonthesectionofthebodybeingviewed.
forexample,anarthroscopy,ortheendoscopyofajoint,theendoscopemustberigidwhereasin
avascularendoscopy,theendoscopemustbeflexibletonavigatethroughabloodvessel.
Theoverallgoalofthesnakecableistotransferlighttothebodyandthentothecamera.
Thiscanbedonewithfiberoptics,whichtakesadvantageofthefactthatiflightistransferred
throughatubeananglenearparallelwiththetube,thenallofthelightisreflectedandnoneis
lost.Oncethelighttravelstotheendofthecable,itthentravelsthroughthelenstoviewthe
scopeofthebody,andthenthelighttravelsbacktotroughthecableandintothecamerafora
digitaldisplay.
Oneofthekeyfeaturesofthiscameraisitsinfravisioncapabilities.Thismechanism
utilizesthephenomenonofblackbodyradiation:thatallmatterabove0Kemitsinfrared
radiation.Insteadofthedopedsilicon,amicrobolometerisused.Amicrobolometermeasuresthe
resistanceonaninfraredabsorbingmaterialandisabletocalculatethetemperaturebasedonthe
changeinresistance.
Asanendoscopiccamera,themainobjectiveistolookintotheinteriorofthehuman
body.Whetherthefieldistheinteriorofabloodvesselorpartofthegastrointestinaltract,the
mainissueisthelackofvisiblelighttoviewtheinteriorwithareasonableresolution.Tocounter
thisproblem,thisdeviceusesalgorithmstogenerateimagesfromotherparametersfromthe
field.Inordertoprocessthesealgorithmsinareasonableamountoftime,thisdeviceneeds
advancedsoftware.

Oneofthecamerasfeaturesisitscomplementarymetaloxidesemiconductor,orCMOS
forshort.Theoldertechnologyforimagesensing,CCD,isbulkyandconsumesabout1,000
timesmorepower.TheCMOS,initiallynotproducingverygoodresolutionimages,hasseen
numerousimprovementswhichnowmakeitcomparabletoCCDimages[18].
Inorderforthecameratodisplayandgenerateanimage,itmusthaveamechanismfor
sensingthelight.Thismechanismisthemostcommonlyusedsemiconductorintechnology
dopedsilicon.Beforelightstrikesthesemiconductorhowever,thelightmustbefilteredsothat
theimagecanbeproperlycolored.Thereare3filtersthatmakeonlyred,blue,andgreenlight
passthroughtoindividualsemiconductors.Withalgorithmsforblendingthedifferentiated
colors,andimagecanbeprocessedanddisplayedonascreenaswellassavedforfurther
analysis.
Toprocessthisinput,thepowerproducedbythesemiconductorfromthelightmustbe
digitizedandstoredinbinarysoanimagingsystemcanreadanddisplaytheimage.By
quantizingtheintensityofthecolorwithan8bitbinarynumber,animagecanbeprocessedsoit
canbedisplayedonamonitor.

IV.

Patents
StrykerCorporationpatentedtheirfirstendoscopiccamerasysteminJanuaryof1999,

underthepatentnumberUS6224542B1.InventedbyMarkusYap,SalmaanHameed,Richard
A.Beutter,andWilliamH.Chang,thepatentwaspublishedabouttwoyearslateronMay1,
2001.Thedevicepatentedessentiallyincludedascope(location2),acamerahead(location3),

andacontroller(location14)(cameracontrollerunit/CCU)usedtobetterviewendoscopic
procedures,whichcanbeseeninthefiguretotheleft.
Thepatentalsoclaimedthevoicecommandcapabilities,
aswellasrealtimeviewing,ofthedeviceasitsown
intellectualproperty.Thisdevicewasuniqueand
requiredpatentingmostlybecausezoomingforthefirst
timebecamedigital,sothattheendoscopebeingused
didnotneedtomoveasmuch.Thisnotonlylessened
surgeryandproceduretiming,italsoassistsphysiciansintargetingareasbetter.Notonlythat,
thedigitalnatureofthedeviceallowedformultipleviewstobeseenatonceonacomputer
screen.Inotherwords,thephysiciansusingthedevicewouldbeabletoseemultipleanglesat
once,asopposedtojustviewingoneaspectoftheprocedurebeingperformed,withouthavingto
fiddlewiththedevice.Beingonthevergeoftheageofpersonalcomputers,thiswasaleapin
innovation,aspriortothis,suchimageswouldhaverequiredprintingandseparateanalyzation.
Additionally,theoperatorofthedevicemayusethevoicecommandstonotonlyzoominand
out,butalsouseadverbstodetailexactlyhowmuchtheydliketoperformthisaction,aswellas
gotoacertainviewofthebody,giventhepriorstorageofacommand[4].Whilethevoice
commandsanddigitalnatureofthispatentwereradical,greatertechnologywasneededtospeed
upprocedures,specificallyinthefocusingofthecamera.
ThispatentwasfollowedquitequicklybyasecondinventionbyBeutterandChang,this
timefeaturinganautomaticnonmechanicalfocus,asopposedtothecomparativelyelementary
manualfocusofthefirstpatent.Patent
US6533721B1
camefromaneedtobetterfocusimages

duringendoscopicprocedures,asthepersonoperatingthescopeoftencannotholditentirely
still,especiallyafteraperiodoftimehaspassedandtheoperatorbecomesweary.Thepatentalso
citedthefactthatdevicesthataccountedforthisproblematthetimeofpatentingrequiredthe
changingofthesizeofthedeviceduringtheproceduretorefocus,whichnotonlyaltersthe
continuumoftheprocedure,butalsohasthepotentialtoharmthepatient.Finally,theinventors
discussedatroublewiththemechanicsofpreviouslyinventeddevicesofthelike.Suchdevices
oftenbrokedownduetoalargenumberofsmallparts,whichagain,couldcauseharmtothe
patient.Inotherwords,theinventorspatentedthelesserpartstoaccomplishtheautomaticfocus
ofthedevice.
Thispatentedtechnologyaccountsfortheseproblemsinanumberofways.Firstand
foremost,thecameraselfadjuststomakeproceduresfaster.Thiswasdonebyadjustingthe
enhancementlevelsofthecameraused,whichessentiallyallows
morepowertobeprovidedtothecamerawithoutinjurytothe
patienttocreateamorehighdefinitionimagetobeused.Thiscan
beseeninthefigureontheright,whichisablock
diagramofthecamerasystem,minustheviewing
mechanismsandotheroptionalattachments.Lookingatthebottomrightofthefigure,thesimilar
camera,onlydifferinginitslevelofsimplicityinthediagram,canbeseen.Notonlydoesthe
camerainthisdevicecreateabetterimagewithinthepresetpowertolerancelevels,italsouses
significantlylesspartsthanthepreviouslymentionednonautomaticmodel,whichcutsbothcost
andrisk.Finally,thisdevicealsodoesnotrequireanysortofsizealterationinordertofocus
whichalsoreducesrisks[2].


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Sincethesetwopatents,therehavenotbeenanyregardingtheHDEndoscopicCamera
devicefromStrykerCorporation.Thatbeingsaid,significantdevelopmentsinthedevicehave
undoubtedlyoccurred,astokeeppacewithtechnologychangesinthemedicalworld.

V.

FDAApproval
ThedevicewasapprovedbytheFDAusingthe510(k)pathway.The510(k)pathwayis

aroutethroughwhichadevicecangetapprovedthroughtheFDAbydemonstratingthatthenew
deviceisatleastassafeandeffective(substantiallyequivalent)asanalreadylegallymarketed
device.Inordertoprovethatadeviceissubstantiallyequivalenttoapredicatedevice,itmust
havethesameintendeduse,similartechnologicalcomparisonsorintendeduse,andhavenew
technologicalinformationandaspects,butwithoutnewdangers,risks,orsafetyconcerns(FDA
PremarketNotification510(k).Inordertodothis,Strykeruseditsoriginalendoscopesystem,
theModel8883chipendoscopiccamera,asthepredicatedeviceforthe1488HD3chipcamera
andapproval[5].
Withtheendoscopebeingsuchawidelyuseddevice,theFDAhaspredeterminedthe
classificationofeachpartoftheendoscopeanditsaccessoriesundertheCodeofFederal
RegulationsTitle21,Sec.876.1500EndoscopesandAccessories.Thisregulationdefinesan
endoscopeandaccessoriesasadeviceusedtoprovideaccess,illumination,andallow
observationormanipulationofbodycavities,holloworgans,andcanals.Alldevicesthatfallin
thiscategoryhavetheclassificationofClassII[1].Theproductcodeusedonthe510(k)
applicationsummarywasGCJ,whichmeansthedevicecategoryusedwasLaparoscope,
General&PlasticSurgery.The510(k)summarystatesthatsincetherewasnoguidance


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documentthatperfectlycoverstheStryker1488HDVideoCamera,thisdocumentwaschosen
astheclosestmatch,andoutlinedthestandardsthatwerefollowedfortheapprovalprocess[5].
Inordertobeapproved,multipletestshadtobeperformedtoproveequivalencetothe
predicatedevice,andthatthedeviceoperatesproperly.TheguidancedocumentforFDA
approvalofExtendedLaparoscopyDevicesoutlinesthegeneralperformanceteststhatmustbe
performedforsuchdevices.Benchtestinghadtobecompletedtoshowabilitytowithstand
pressuresassociatedwithlaparoscopicsurgery.Animaltestingwasconductedtoconfirm
compatibilityofthedevicewithlivingtissue,andtoensurecurrenttechniquescouldbe
performedwiththedevice.Finally,clinicaltrialshadtobeperformedtoconfirmtheresultsof
thefirsttwotestingphasesinhumans.
ToprovethattheStryker1488HDVideoCamerawithInfraredCapability,was
significantlyequivalenttoitspredicatedevice,theStrykerModel888VideoCamera,Stryker
statedthatthe1488hasthesametechnologicalcharacteristicsasthepredicatedeviceinthe
followingareas:andthenwentontolistOperatingprinciple,Softwarearchitecture,Electrical
characteristics,Mechanicalcharacteristics,Performancecharacteristics,andEnergysource.
Thetwodevicesalsohavethesameintendeduse,identicalindicationsforuse,andthesame
technologicalcharacteristics.Eachofthesesimilaritycategorieshelpedtoprovesignificant
equivalencetothepredicatedevice.
AccordingtotheFDAapprovalandthe510(k),thedevicewassubmittedforFDA
approvalonNovember18,2013andwasapprovedonDecember16,2013.Thisshort
turnaround(onlyaboutonemonth)intheFDAwaslikelyduetothefactthattheysaidthatit


12

wassignificantlyequivalenttotheirpreviouslyapproveddevice,andtheonlychangemadewas
theinclusionoftheinfraredcapabilities.

VI.

ProductDevelopment

StrykerHDmodelcamerashavebeeninproductionsincethelate1990s.Theoriginal

machine,theModel888VideoCamera,waspatentedandapprovedforretailin2001.This
systemincludedthecameracontrolunit(CCU)andacablethatconnectedthecameraheadtothe
CCU.Therewerefourprogrammedfunctionsonthecameraheadthatallowedtosurgeonto
makeslightadjustmentstotheimage.TheModel8883ChipCamerahaditsdownfallsinterms
ofconvenience,however.Itneededtobeconnectedtoabulkyinterfacewithmultiplecable
attachments,whichcausedclutterintheoperatingroom.Thecameraandallitscableshadtobe
sterilizedinbetweeneachuse,whichdetractedfromitsoperatingroomefficiency.Thecamera
alsoneededtobecappedandhandsterilized.Anotherproblemwiththiscamerawasthatit
producedlowresolutionimagesduetotheconstraintsofpatientsafetyandburnprevention.The
Model8883ChipCameraoperatedona30wattlightsourceandofferedsurgeonsimageswith
a768x494presolution[11].
Strykerimprovedupontheirlaparoscopicvideotechnologywiththereleaseoftheir
secondgenerationModel1188HD3Chipcamera.Themostnotableimprovementto
accompanythereleaseofthisnewmodelwasitsabilitytobesteamsterilized,whichimproved
theturnaroundtimeandefficiencyofthecamerawithintheoperatingroom.Duetoitsquick
sterilizationcapability,thissecondgenerationcamerawasabletobemadeavailabletomore
patientsthaneverbefore.Model1188HDfeatured1280x1024poutputforhighresolution


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videos,aswellas10bitdigitalprocessingforhigherresolutionimagesandincreased
intraoperativebrightness.Also,thesecondgenerationmodelcameequippedwithfour
programmablebuttonssothatsurgeonscouldeasilymakelightingandimageadjustments
directlyfromthecamerahead[17].

BuildingupontheinitialimprovementsofferedbyModel1188HD,Strykerreleasedthe

thirdgenerationinthe3chiplaparoscopiccamerafamily:theModel1288HD.The
thirdgenerationlaparoscopiccamerahadanevenhigherresolutionat1920x1080pwhich
offeredsurgeonsimagesofimprovedclarity,
sharpness,andfocus.Themostimprovedfeatureof
Model1288HD3Chipcamerawasitswireless
transmissioncapabilitieswhenusedwithaStryker
WiSeflatpaneledmonitoringsystem.Thewireless
capabilityallowedfortheremoval
of30ftlongDVIcablesfromthe
operatingroom,whichinturnreducestheclutterandhazardousrisksassociatedwithsaidcables.
Thethirdgenerationmodelalsoincludedfourfullyprogrammablebuttonsonthecamerahead,
ascanbenotedinFigure3ontheleft[16].
ThemostrecentmodelofStrykersHDlaparoscopiccameraswasputonthemarketin
2013.The1488HD3ChipCameraisafourthgenerationmodelthatoffersadvancedCMOS
technologytoprovidetheclearestimagesyet,asmentionedpreviously.Thisfourthgeneration
modelisdesignedprimarilyforincreasedpatientsafety,withitsnotableabilitytooperatea
300wattlightsourcethatprovidesqualityresolutionimageswithminimalrisktothepatient.


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The1488HD3ChipCameraalsofeaturesninesurgicalspecialtysettings,whichallowthe
surgeontoadjustthelightandcolortailoredtothespecifictypeofendoscopicprocedurebeing
performed.Finally,Strykersfourthgenerationlaparoscopiccameraboastsitsinfravision
compatibilitywhichallowscriticalanatomytobeeasilyidentified[14].Byandlarge,Strykers
HDcameralinehaschangedslowly,butdramatically,overthecourseofthepastfifteenyears,
enablingthemtoofferpatientsandsurgeonsasaferandmoreefficientlaparoscopiccamera,and
ultimately,improvedprocedures.


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VII.References
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EwjW19aJ2LnJAhWBVD4KHa1FBd0Q6AEIHTAA.
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]CenterforDiseaseControl,'NumberofAllListedProceduresforDischargesfrom
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16

[8]Laparoscopyhospital,'SterilizationandUpkeepofLaparoscopicInstruments&Equipment',
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17

[15]R.Fields,'35StatisticsAboutGI/Endoscopy',
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