132

DESIGNOFCARDIACPACEMAKERS

6
Electrodes,Leads,andBiocompatibility
BrianK.Wagner

Apacemakersystemapplieselectricalstimulitoinducecardiacmusclecontraction.
Pacemaker researchers apply principles of engineering and materials science to
interfacetechnologywithbodysystems.Materialsusedinmanyotherengineering
applications are often not acceptable in the human body. We therefore find or
develop biocompatible materials and shape them into useful pacemaker
components.Wemustunderstandthebodysbiochemicalandpathologicalsystems
tominimizeforeignbodyreactions.Reducinginteractionsbetweenthepacemaker
andbodycontributestolongevityoftherapy.Apatientssafety,livelihood,and
comfort rely upon successful adaptation of technology into his or her body.
Successful pacing therapy depends upon the ability of an electrode to safely,
effectively,andefficientlystimulateexcitablehearttissueandsenseintracardiac
signals.Pacemakerleadsdeliverelectricalsignalstoandreceivesignalsfromthe
heart. Lastly, the reaction of the body to the materials and device, or
biocompatibility,mustbeacceptable.
6.1PACEMAKERELECTRODES
Overallefficiencyandefficacyofapacemakersystemdependuponanelectrodes
ability to interface between the two realms of physiology and electronics. The
utilityofpacingtechnologyisdiminishedorlostentirelyifaneffectiveinterface
cannotbeestablishedbetweenthesetwosystems.Thissectioninvestigatesroles
and applications of pacemaker electrodes and how engineers, physicians, and
scientistsimprovecardiacpacingviaevolvingelectrodetechnology.
6.1.1Electroderolesinpacemakersystems
Themodernpacemakerelectrodeoftenfulfillstwomajorroles.Thefirstisthe
introductionofcathodalstimuli,producedbythepulsegenerator,intoexcitable
myocardial muscle. If implemented, the second role is to optimally sense
intracardiacelectrocardiogramsandconductthembacktothepulsegeneratorfor
signalprocessingandalgorithmcontrol(Sinnaeveetal.,1987).

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DESIGNOFCARDIACPACEMAKERS

Figure6.1showsanexampleofamodernporoussteroidelutingelectrode.
The implementation of porous electrodes began in the late 1970s at Cardiac
Pacemakers,Inc.[CPI,St.Paul,MNU.S.A.](Mugicaetal.,1988).Variousporous
andsteroidelutingelectrodeshaveprovidedsignificantadvancesinthepacemaker
industry. Porosity utilizes the principle that the ratio of the electrode tips
electricallyactivesurfaceareatothetipsoverallsizeshouldbelarge(Mugicaet
al.,1988;Schaldach,1992).Steroidelutiondesignsincreasepacingefficiencyand
sensingsensitivitybyreducingencapsulationoftheelectrodetip.

picfrom(11,2,215).letterwritten.

Figure6.1Amodernpacemakerelectrode.TheMedtronic[Medtronic,Inc.,Minneapolis,MN
U.S.A.]model4003CapSureunipolartinedporouselectrodeisanexampleofaporoussteroid
elution electrode. Behind the porous tip surface is a silicone rubber plug filled with an
inflammationsuppressingsteroid.Thesecretionofthisdrugthroughthetipsurfacedecreases
inflammationandresultingencapsulation.Thisincreasestheelectrodespacingefficiencyand
efficacyandsensingsensitivityFromMond,H.,Stokes,K.B.,Helland,J.,Grigg,L.,Kertes,P.,
Pate,B.,andHunt,D.1988.Theporoustitaniumsteroidelutingelectrode:adoubleblindstudy
assessingthestimulationthresholdeffectsofsteroid.PACE,11:214219.

Theprimarydesigncriterionforelectrodedesignissafecardiacstimulation.A
patientssafetyisofutmostimportance.Minimizingenergylossfromasmallpulse
generator battery source is another important electrode design consideration.
Charge consumption from the battery is reduced to provide extended life.
Electrodesusedwithtodaysdualchamberandrateresponsivepacemakers,which
inherentlydrawincreasedcurrentfromthepowersource,mustespeciallyreduce
currentdrain.Becausetheheartbeatsanaverageexceeding85,000timesaday,the
potentialexiststhatarelativelylargeamountofenergycouldbeinefficientlyused.

ELECTRODES,LEADS,ANDBIOCOMPATIBILITY

134

Duringpacing,thepulsegeneratoractsasapowersourcewhiletheheartactsasan
electricalload.Whenthepacemakeroperatesinsensingmode,theheartbecomes
thesourceofelectricalenergyandthepacemakersensingcircuitbecomestheload.
These differing and alternating roles sometimes require different design
considerations.
Other important electrode design criteria include:biocompatibility,
biostability, electrode size, invasiveness to cardiac and circulatory functions,
fixationintohearttissue,andeaseofclinicalmanipulation(implantationandif
necessaryremoval).Whileoverallsystembiocompatibilityisaddressedspecifically
in section 6.3, electrode tip biocompatibility is of special concern because it
directlycorrelatestoelectrodeefficiency.
6.1.2Electrodemyocardiuminterface
This section explores the electrochemical, ionic, and electrical current
characteristicsexistingattheboundarylayerbetweenanelectrodetipandheart
tissue.
The primary reason a pacing electrode is introduced into the heart is to
electricallystimulateexcitablehearttissueandinducemuscularcontraction.To
accomplish this, adequate electrical stimuli must first be applied to excitable
cardiac cells, or myocardium. An artificial pacemaker supplies an electrical
potential difference to myocardium via an electrode. The electrode and tissue
interface is a complex one. Electrical engineering applications (such as pulse
generator circuits) utilize electronic conduction while biological systems
implement ionic conduction. The interface where these two different charge
carryingsystemscometogetherisknownasanelectrochemicalphaseboundary.
Electrochemicalphaseboundary
Thehumanbodyisoftenmodeledasasalinereservoirconsistingofionssuchas:
H+,Na+,K+,Cl, andothers.Theseionsfulfillrolesthroughoutbodilysystemsin
electrochemicalreactionssustainingcellularlife.Bodilyfluids,consistingprimarily
ofwater,areelectrolytesduetotheirdisassociatedsubstanceionswithinsolution.
Figure6.2showsanelectrodesurfaceandtheresultingphaseboundarywith
hearttissuepriortotipencapsulation.Notethattheendothelialandendocardial
tissuelayersarenotelectricallyactive;theyareprotectivecellularmembranes.An
electricalfieldintroducedbyanelectrodemustpassthroughthesetwothinlayers
toinfluencethenearestmembraneofanexcitablemyocardialtissuecell.

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DESIGNOFCARDIACPACEMAKERS
Endothelium
Electrolyte
Electrode

Endocardium
Excitable myocardial
muscle tissue cell
layers

VT

Figure 6.2 Electrodetissue phase boundary prior to encapsulation. Voltage VT stimulates

myocardialactionpotential.

Figure6.3(a)showsafirstorderapproximationoftheelectronicandionic
interactions occurringat thestimulatingcathodalelectrodeelectrolyteinterface.
Morecomplexmodelscanandhavebeendeveloped.Anelectricalphaseboundary
isdefinedasaninterfacewhereononesideelectricalchargeiscarriedbyelectrons,
whileontheothersidechargeiscarriedbyions.Electronsintheelectrodeare
drawntotheinterfacesurfacebytheirattractiontopositiveionspresentinthe
bodilyelectrolyte(Na+andH+,forexample).Electrolytecationsaredrawntothe
interfacesurfacebytheirattractiontotheelectrodeselectrons.Equalandopposite
chargeconcentrationsariseoneachsideoftheelectrodeelectrolyteinterfaceand
anelectricalfieldisthusestablished(Deconinck,1992).

ELECTRODES,LEADS,ANDBIOCOMPATIBILITY
Primary water
layer

136

Secondary water
layer
Interface particles

Electro lyte

Electro de

(a)

Water molecule
Cation
Electron
M O

M O

Metal oxide
complex

Helmholtz double layer

CH
(b)
RE
RF
Figure6.3(a)Firstorderapproximationofstimulatingcathodalelectrodeelectrolyteinterface.
PrimaryandsecondarywaterlayerscompriseasimpleinterfacemodelknownastheHelmholtz
doublelayer.Notecationelectronmutualattractionstooneanother.Watershellssurrounding
ionsareknowncollectivelyashydratedions.Metaloxidecomplexes(indicatedasMO)are
valuable constituents in sustaining reversible interface reactions. Reversible reactions, as
opposedtoirreversiblereactions,limitcellulardamageandinflammationinnearbyendothelium
and endocardium. Electrode tips implementing metal oxide materials help prevent chemical
reactions and thus limit corrosion. (b)The Helmholtz double layer physically exhibits
characteristics of plate capacitor CH due to surface area of interface, dielectric constant of
primarywaterlayer,anddistancebetweenelectronsandcations.Increasingthecapacitanceof
CH increases reversible charge transfer (RCT) and thus reduces destructive Faradic current.
Resistance attributed to electrolyte is shown by RE. This interface approximation is thus
commonlymodeledasaparallelRCnetworkinserieswithresistiveelementREFromSchaldach,
M.M.1992.Electrotherapyoftheheart.Berlin:SpringerVerlag.

Figure6.3(a)showsaprimarylayerofwatermoleculesnearesttheelectrode
surface.Morecomplexmodelsmayincorporatemanymoreprimarylayers.These
primarylayerwatermoleculesnearlycompletelycovertheelectrodetipssurface.
Notethatdipoledwatermoleculestendtoalignthemselvesundertheinfluenceof
theinducedelectricfield(Waltonetal.,1987).
Figure6.3(a)alsoshowstheattractionofpositivelychargedcationstothe
electrodetipssurface.Electricfieldsexertedbythesecationsaresufficientenough

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DESIGNOFCARDIACPACEMAKERS

todrawdipoledwatermoleculesaroundthem.Thus,theseionsdevelophydration
shells(Schaldach,1992;Waltonetal.,1987).Theseionwatershellcomplexesare
knownashydratedions.Positivehydratedionsaredrawntowardstheelectrode
electrolyte interface. Together the hydrated ions comprise the secondary water
layer. The primary and secondary water layers comprise the Helmholtz double
layer,asproposedbyHelmholtzin1879(Schaldach,1992;Waltonetal.,1987).
Figure 6.3(b) shows that a simple Helmholtz double layer approximation
correspondstoaplatecapacitorschematicallyrepresentedbyCH.Thevalueofthis
Helmholtz capacitance is determined by three physical factors: the dielectric
constantoftheprimarywaterlayerr;theactivesurfaceareaoftheelectrodetipa;
andthedistancedbetweentheelectrodeschargeandtheelectrolytesions:
CH

0r a
(6.1)
d

where0isthepermittivityoffreespace.
Electrical current from the stimulating cathode into the tissue occurs as
electrons pass from the electrode tip into the electrolyte. This type of current,
known as Faradic current, is undesirable. We prefer instead to minimize
electrochemical reactions as a means of charge transfer to reduce biological
destruction.
Theconcentrationofelectronspresentinthestimulatingelectrodeexceedsby
orders of magnitude the concentration of ions in the electrolyte (Bockris and
Drazic,1972;Schaldach,1992).Resistanceofelectronstoflowfromtheelectrode
intotheelectrolyteisknownasreactioninhibitionandisshowninFigure6.3(b)as
RF, the Faradic resistance. Current flowing through Faradic resistance depends
largely upon the tips stimulating potential. Faradic current induces irreversible
reactionsintheelectrolyteandwouldthusideallybenegligible.
Instead of destructive irreversible reactions induced by Faradic currents,
reversiblereactionsaremuchmoredesirable.Reversiblechargetransfer(RCT)can
beachievedintwoways.
NoteinFigure6.3(a)therelationshipbetweentheparticlesindicatedbythe
M and O. Platinum and iridiumtwo metals commonly implemented as
electrodetipsurfacesarerepresentedcollectivelybytheMindicatingmetal.
O represents oxygen. It is believedthat platinum, iridium, and related metals
absorboxygenatanelectrodeelectrolyteinterface(Waltonetal.,1987).Iftrue,a
metaloxide(MO)complexismostlikelycreatedasdetailedinthefollowing
reductionoxidation reactions. Platinum isusedas the electrode material in the
followingexample(Dymond,1976):
4e+O2+4H+2H2O(6.2)
Pt+2H2O2PtO+4H++4e(6.3)
Thus, the first way to achieve RCT is by successful implementation of
reversible reductionoxidation reactions at the electrodeelectrolyte interface.

ELECTRODES,LEADS,ANDBIOCOMPATIBILITY

138

However, this charge transfer reversibility is limited by implemented electrode

materialswhichmaybecontaminatedbybloodconstituents.
ThesecondmethodtoobtainRCTissimplycharginganddischargingthe
Helmholtz capacitance shown in Figure 6.3(a) as CH. In order to improve the
reversible charge transfer by means of CH, the capacitance must be increased.
AccordingtoEquation6.1,thiscanbeachievedbyincreasingtheactiveelectrical
surfacearea a.Section6.1.4discusseshow a canbemadesubstantiallylargeby
implementingsurfaceporosity.
Overallpacingsystemelectricalmodel
Figure6.4showsasimpleelectricalmodelofatypicalpacemakersystem.
Pulse
generato r

Catho de

Tissue

C HC a
S1

VB

S2

CR

Cc

RC

S3

C HA ai
RA

RFC

RFA

RE

RS

C ma
2

Rt

Ano de

Figure 6.4 Simple pacing system electrical model as correlated with exhibited physical
characteristicsof:device,materials,tissue,andelectrochemicalcomponents.Thismodelisbased
only uponmeasurable system components andexcludes empirical assumptions. Components
include:thepulsegenerator,stimulatingcathode,anode,andtissue.FromBolz,A.,Frhlich,R.,
and Schaldach, M. 1993. Elektrochemische aspekte der elektrostimulationein beitrag zur
senkungdesenergiebedarfs.InM.HubmannandR.Hardt(eds.) Schrittmachertherapieund
hmodynamik.Mnchen:MMVverlag.

FourmajormodelcomponentsareshowninFigure6.4:thepulsegenerator,
cathode,anode,andtissue.VBrepresentsthepulsegeneratorsstimulationvoltage.
CRisthepulsegeneratorsreservoircapacity.Ccisthecouplingcapacitybetween
the pulse generator and the leads. Switches S1 through S3 represent various

139

DESIGNOFCARDIACPACEMAKERS

switching elements designed in many pacemakers to permit charging and

dischargingofvarioussystemcapacitances.
Theleadresistancesforthecathodeandanodeareshownby RC and RA,
respectively. The cathode and anode specific Helmholtz capacitances CHC and
CHA,respectively,multipliedbytheirrespectiveelectrodeareasaandairesultin
each individual electrodes Helmholtz capacitance. TheFaradic resistances RFC
andRFAvarywiththestimulatingvoltage.
In the tissue, RE represents the resistance comprised by electrolytes. RS
designates the shunt capacitance in which current is able to pass through non
excitabletissueandbloodoutsidethedesiredcurrentpath.Thecellularmembrane
specificcapacitance Cm multipliedbythecathodesareadividedbytwosidesis
assumed as being proportional to the number of cells directly surrounding the
cathode. Nonexcitable cells within the current path contribute to the tissue
resistanceRt.
Astimulationpulseisconsideredeffectiveifitchargesamyocardialcells
membrane above its stimulation threshold voltage VT. Using Laplace
transformationanalysisandknowingtypicalvaluesformodelcomponentsshown
inFigure6.5enablescalculationofthisstimulationthreshold.
Parameter,symbol
Reservoircapacity,CR
Couplingcapacity,Cc
SpecificHelmholtzcapacity,
CHC,CHA
Totalleadresistance,RL=RC+RA
Surfaceareaofcathode,a
Surfaceareaofanode,ai
Pulsewidth,T
Cellmembranecapacity,Cm
Tissue/electrolyteresistance,
R=RE+Rt
Shuntresistance,RS
Depolarizationvoltage,VD

Smooth
Porous/
Fractal

Unipolar
Bipolar

Initial
Chronic

Typicalvalue
10F
10F
0.2F/mm2
40F/mm2
50
10mm2
10cm2
50mm2
0.5ms
0.01F/mm2
40k
70k
600
30mV

Figure6.5 TypicalvaluesofpacingsystemelectricalmodelcomponentsshowninFigure6.4.
From Bolz, A., Frhlich, R., and Schaldach, M. 1993. Elektrochemische aspekte der
elektrostimulationeinbeitragzursenkungdesenergiebedarfs.InM.HubmannandR.Hardt
(eds.)Schrittmachertherapieundhmodynamik.Mnchen:MMVverlag.

ThefollowingsimplificationscanbemadefromFigure6.4:

ELECTRODES,LEADS,ANDBIOCOMPATIBILITY

140

R=RE+Rt(6.4)
RL=RC+RA(6.5)
1
1
1
1
C1

C R Cc CHCa CHA ai
C2

(6.6)

Cma
(6.7)
2

Laplacetransformationsimplificationresultsinthefollowingexpressionfor
thestimulationthresholdvoltageVT:
VT

2VD y 2 4 x

C1 RL e p1T e p2T

(6.8)

wherethepolesp1andp2aredefinedas:
y y 2 4x (6.9)
p1
2x
y y 2 4x (6.10)
p2
2x
andvariablesxandyaredeterminedby:
x RL RS RL R RSR C1C2 (6.11)
y RS R C2 R L RS C1 (6.12)
Equation6.13showsthat C1 and C2 aresignificantfactorsinreducingthe
amountofchargerequiredtoraisetheexcitablecellsmembranepaststimulation
threshold.Figure6.5showsthatfractalorotherporoustipsurfacesclearlyprovide
higherspecificHelmholtzcapacitancestomoreefficientlyutilizeavailablecharge
fromthebatterysource.
ThechargerequiredforasinglestimulationpulseQTisthuscalculatedby:

QT

V T C1

2
y 4x

e p1T 1 R R C p 1
e p2 T 1 RL R C2 p2 1

L
2
1

p1
p2

(6.13)

141

DESIGNOFCARDIACPACEMAKERS

Note that this model is based upon a two dimensional representation of a

pacemakersystem.Severaltissuecomponentsrepresentedbytwoleadresistorsand
capacitorsareactuallythreedimensionalbiologicalregions.Whileresistivetissues
showninFigure6.4aremodeledasbeingtwodimensional,currentisphysically
abletodivergethroughthistissueinthreedimensions.Morecomplexmodeling
systemscanbedevelopedusingthreedimensionalfiniteelementtechniques.
Thismodelisbasedonlyuponmeasurablecomponentsandexcludesempirical
assumptions(Bolzetal.,1993).
Inflammation,encapsulation,andstimulationthresholdchange
Theintroductionofaforeignbodyintohumantissueoftentriggersacomplicated
process known as inflammation. During inflammation, the body attempts to
encapsulate and isolate a foreign object. We must comprehend the processes
associated with tissue inflammation and encapsulation to explain electrode
performancechangesduetoforeignbodyreactions.
Asanelectrodeisimplanted,itisoftenplacedagainsttheendocardiumorinto
themyocardium.Proteinsareabsorbedtotheelectrodesurface,wheretheychange
instructure,desorb,andinduceanimmunesystemreaction.Localcapillarydilation
thenoccurs.Phagocyticcells,includingmonocytesandmacrophages,infiltratethe
regionandreleaselysosomalinflammatorymediators(variousoxidants,hydrolytic
enzymes, and chemotactic agents). In a more mature inflammation stage, this
phagocyticactivityoccurs at boththe electrodeelectrolyteinterfaceand inthe
surroundingmyocardium,eventuallyresultinginthedeathofnearbymyocytesand
local necrosis (Henson, 1971; Henson, 1980; Salthouse, 1984; Stokes and
Anderson,1991).Additionally,thelysosomallyreleasedinflammatorymediators
maydissolvethecollagenstructureholdingnearbymyocyticcellsintheirorderly
fashion(Robinsonetal.,1983).Acollagencapsulethenformsaroundtheelectrode
tip(MondandStokes,1991).Betweenthecollagencapsuleandtheelectrodeexist
oneormorelayersofremainingmacrophagesandforeignbodygiantcells,which
become the interface between the electrode and the heart tissue (Stokes and
Anderson,1991).
Inflammation begins immediately upon electrode implantation (Schaldach,
1992;StokesandAnderson,1991).Duringinflammation,therequiredstimulation
voltagerequiredtoinducemyocardiumcontraction can increase.Somemodern
electrodessignificantlysuppressinflammationbyusingsteroidelutiontechniques
or relatively biocompatible materials. Much of the required stimulation voltage
increase, if any, can be attributed to inflammation and the collagen network
developingbetweentheelectrodeandmyocardium.
Figure6.6showsencapsulationofavitreous(orglassy)carbonelectrodetip.
Tosomedegreeoranother,thistypeofgrowthistypicalformanypacemaker
electrodes.

ELECTRODES,LEADS,ANDBIOCOMPATIBILITY

142

picfrom(11,11,1753).letterwritten.

Figure6.6 Resultingencapsulation ofavitreouscarbonelectrodetip(magnification: 250).

Thecapsule,comprisedprimarilyofcollagen,addsaresistiveelementbetweentheelectrodeand
theelectrolyteandincreasestheeffectivesizeoftheelectrodetip(thelighterareaontheleft).
Myocardiumisshownonthefarright.FromBeyersdorf,F.,Schneider,M.,Kreuzer,J.,Falk,S.,
Zegelman, M., and Satter, P. 1988. Studies of the tissue reaction induced by transvenous
pacemakerelectrodes.I.microscopicexaminationoftheextentofconnectivetissuearoundthe
electrodetipinthehumanrightventricle.PACE,11:17531759.

Macrophagesandforeignbodygiantcellsmigrateintothepores,cracks,or
grooves of an electrode tips surface. In addition to the collagen capsule
surroundingthetip,thesecellsincreasetheeffectiveelectricallyactivesizeofthe
electrode.Indeed,anextremelysmalltipcanbepotentiallybiologicallydestructive
due to Faradic current. Yet, too large an electrode size results in a decreased
electric field density at the myocardium. Electric field density decreases as a
function of the square of the distance between the electrodes surface and the
myocardium(Irnich,1973;Irnich,1975).
6.1.3Idealcharacteristicsofelectrodetipforpacingandsensing
Two primary electrode tip criteria are important electrically for pacing and
sensing:thetips polarization characteristics (dynamicinterface impedance) and
maximizing electric field density. Figure 6.7 shows ideal electrode tip design
characteristicsforefficientpacingandoptimalsensing.

143

DESIGNOFCARDIACPACEMAKERS
Pacing

Sensing

Electrode polarization
Microscopic
surface area
Electric field density

Macroscopic
geometric size

Figure6.7 Idealelectricaldesigncriteriaforintracardiacelectrodetips.Forbothpacingand
sensing,energylossassociatedwithelectrodepolarizationisminimizedbyincreasingthetips
microscopicsurfaceareaa.Decreasingthegeometricsizeoftheelectrodetipincreaseselectric
fielddensityrequiredtoinducemyocardialmusclecontractionduringpacing.Thus,ahighratio
ofmicroscopicsurfaceareatomacroscopicgeometricsizeisdesirablefortipimplementations.

Pacingefficacyandefficiency
Thegoalofpacingistosafelyintroduceeffectivecathodalstimulitomyocardial
tissueviatheelectrodetip.Figure6.7showsthattomostefficientlyaccomplish
this, electric field density is increased while polarization loss at the electrode
electrolyteinterfaceisminimized.
Figures6.8(a)and(b)showthatastipencapsulation increases,theresultant
effective size of the tip increases radially. Increasing the geometric tip size
dispersestheelectrodesinducedelectricalfieldandthusdecreasestheefficacyof
theelectrode.Thisreductioninfielddensitydecreaseselectricalinfluenceonany
onemyocardialcell.Morechargemustthereforebesuppliedbythepulsegenerator
toinducethesameeffectpriortoencapsulation.Toreduceradialdispersionofthe
inducedelectricalfield,thetipsgeometricsizeshouldbedecreased.
Section6.1.2describeshowelectrodepolarizationlossescanbedecreased.
One way to decrease charge loss is described as successful implementation of
reversible reactions at the electrodeelectrolyte interface. The second method
describes increasing the reversible charge transfer by increasing the Helmholtz
capacitanceCH.Thissecondmethodrequiresthattheelectrodetipsactivesurface
areaabeincreased.Bothmethodsincreasepacingefficiency.

ELECTRODES,LEADS,ANDBIOCOMPATIBILITY

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144

su
le

(b)

Figure6.8Electricalfieldinducedbyanelectrodetip.(a)Inthisidealcase,noencapsulationof
theelectrodetiphasyetoccurred.(b)Inreality,however,processofencapsulationresultsina
collagenous network surrounding tips surface area. This effective enlargement of the tips
geometricsizeresultsinaradialdispersalofemittedelectricfieldanddecreasedpacingefficacy.

Detectionsensitivity
Thesameelectrodeusedtopacemyocardialtissueiscommonlyalsodesignedto
sense,ordetect,anelectrogramsignalfromwithintheheartanddeliverittothe
pulsegenerator.Somepacemakersutilizethisnaturalcardiacsignalinalgorithm
controlfordemandand/orrateadaptivepacingsystems.
Because pacing and detection applications share the same electrode
electrolyteinterface,electrodepolarizationlossesforsensingarereducedinthe
samemannertheyareforpacing.Methodsavailableforreducingtheseinterface
lossesaredescribedinsection6.1.2.
Chapter8discussesmethodsofenhancingdetectionsensitivitybyutilization
ofsophisticatedamplifierdesigns.Combinedwithhighlyselectivefilters,these
amplifierscommonlyhavebothextremelyhighinputresistancesandgains.They
oftenprovidehighfidelityreproductionsofcardiacsignalstothepulsegenerator.
Amajorcriteriaforelectrodedesignisminimizingchargelossfromasmallbattery
sourcetoincreasedevicelongevity.Muchofapacemakersystemschargelossis
attributedtopacing.Enhanceddetectioncircuitryinternaltothepulsegenerator
providesdesignflexibilityforincreasingpacingefficiencyandextendingdevice
longevity.

145

DESIGNOFCARDIACPACEMAKERS

6.1.4Modernelectrodedesign
In addition to conservation of battery charge, there are other electrode design
considerations. Some of these include: (1)tip size, shape, and porosity;
(2)electrodebodyandtipmaterials;(3)steroidelutiontechniques;(4)electrode
implantationandfixation;and(5)costreduction.Generallyacceptedguidelinesfor
electrode design include: small size (although not too small to limit Faradic
currents), high active surface area, biocompatibility, and relatively inert,
noncorrosivematerials.
Tipsize,shape,andporosity
Fortraditionaldesign,theelectrodetipsradiusshouldbelessthanorequaltothe
thicknessofthecollagenouslayerthatwillinevitablyencapsulatethetip(Mond
andStokes,1991).Thiscriteriaistheconsequenceofthephenomenathatelectric
fieldstrengthdecreasesasafunctionofthesquareofthedistancebetweenthe
activetipsurfaceandthemyocardium(Irnich,1973;Irnich,1975).Acorrectly
chosenradiusresultsinatipsizeoptimizedformaximalelectricfielddensityatthe
myocardium.
Thegeometricsizeofahemisphericaltipisdeterminedby:
A 2 r 2 (6.14)
Ifthethicknessoftheexpectedencapsulationlayerisbetween0.80and1.4mm,
thesurfaceareaofthetipiscalculatedtobebetween4.0and12mm 2 asthe
optimal tip radius is assumed to be 0.80 to 1.4 mm, respectively. Effective
traditionalpacingcathodescommonlyexhibitgeometricsizeswithinthisrange.
Note that as an encapsulation layer accumulates on the surface of the tip, the
effectiveradiusandsizeoftheelectricfieldemittingactivesurfaceincreases.This
reducespacingefficiency.
Somemorecontemporarydesignshavetipsizessmallerthan4.0mm2dueto
suppressed inflammation and reduced encapsulation techniques. The next two
sections will discuss how different tip materials and steroid elution techniques
providethecapabilitytodesignsmaller,moreefficientelectrodes.
Inadditiontosize,theevolutionofpacemakerelectrodeshasalsoincluded
severaltypesoftipsnothavingsimpleroundedsurfaces.Duringthepastdecade
electrodedesignershavedevelopedelectrodetipshavingawidevarietyofdifferent
geometricshapes.Sometipsarenearlysphericalorhemispherical.Othertipsare
flat,annular,ringshaped,orbarbed(similartothatofafishhook).Intermedics
[Intermedics, Inc., Angleton, TX U.S.A.] has introduced an IROX model
electrode implementing sharp edges and points for localized concentration of
current.Debatestillcontinuestowhetheranyofthesedesignsalonecontributeto
increasedpacingefficacy(Adleretal.,1990;Djordjevicetal.,1986;Karpawichet
al.,1992;Mugicaetal.,1988;PiogerandRipart,1986).
To reduce electrode polarization losses for pacing and sensing, the active
microscopicsurfaceareaofanelectrodetipcanbeincreasedwithoutnecessarily

ELECTRODES,LEADS,ANDBIOCOMPATIBILITY

146

increasingthetipsgeometricsize.Theactivesurfaceareacanbegreatlyincreased
ifthetipssurfaceisdesignedtobeconduciveforbodilyelectrolytestoflowinto
anysurfacemicrocavities.Collectivelyknownasbeing porous,severalindustrial
processeshavebeendevelopedtoproducehighactivesurfaceareas.Figures6.9(a)
through(e)showelectronmicroscopescansoffivedifferentporoussurfaces.Note
thatinallofthedifferentporoussurfacesshowninFigure6.9thatmicroscopic
grooves, crevices, or pores exist for electrolyte to flow into or between. The
microscopicridgesandedgesgeneratedbythesevarioussurfaceprocessesincrease
thetipsurfacearea.Inmodernporouselectrodes,microscopicsurfaceareashave
beenreportedtoexceedmacroscopicsurfaceareasbyfactorssometimesexceeding
1,000(Schaldach,1992).Othermethodsofcreatingporoussurfacesnotshownin
Figure6.9includesinteringwheremetallicpowderispartiallyweldedtogether
by application of nonmelting heatand chemical vapor deposition (CVD)
(Schaldach,1992).

JP/JP(11,11,1746)(11,11,1746)(Schald,163)(9,6,1224)
t1b

2b

(a)(b)(c)(d)(e)
Figure6.9Scannedelectronmicrographsofvariousporoussurfaces.(a)Fractalcoating(From
Biotronik[Biotronik,Inc.,Berlin,Germany]),(b)MeshedCPImodel4116.FromMugica,J.,
Henry,L.,Atchia,B.,Lazarus,B.,andDuconge,B.1988.Clinicalexperiencewithnewleads.
PACE, 11:17451752,(c)ActivatedcoatingSorinmodelS100.FromMugica,J.,Henry,L.,
Atchia, B.,Lazarus, B.,andDuconge,B.1988.Clinical experience withnew leads. PACE,
11:17451752, (d) Physical vapor deposited (PVD) coating. From Schaldach, M. M. 1992.
Electrotherapy oftheheart.Berlin:SpringerVerlag,and(e)Vitreous(DeadSeaScroll,The
InstituteofPhysicalandChemicalResearch,Saitama,Japan.FromKatsumoto,K.,Niibori,T.,
Takamatsu,T.,andKaibara,M.1986.Developmentofglassycarbonelectrode(deadseascroll)
forlowenergycardiacpacing.PACE,9:12201229.

Figure6.10showshowpacingvoltagelosscanbereducedusingaporous
electrodetipsurfaceasopposedtoarelativelysmoothtipsurface.
Electrodematerials
Therearegenerallytwodifferentcomponentscomprisingastandardelectrode:the
electricallyactivetipandtheelectrodebodyhousing.Bothmustbebloodand
tissuecompatible.

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DESIGNOFCARDIACPACEMAKERS

While general biocompatibility is discussed in section 6.3, electrode tip

biocompatibility is especially important. Well chosen tip materials potentially
reduceinflammation.Inadditiontobeingtissuecompatible,theelectrodetipmust
alsobebloodcompatible.Thismeansthatthematerialmusthavealowaffinityfor
proteinbindingandnotinducethrombosesandembolisms.
Materialscommonlyusedforelectrodetipsinclude:titaniumanditsalloys,
platinumanditsalloys,iridium,carbonandmetallicactivatedglass(commonly
referredtoasbeingvitreous),andElgiloy.Titaniumoritsalloysusedaselectrode
tipsareoftencoatedwithplatinumand/oriridiumtopreventnonconductivelayers
fromdeveloping.

Pacing voltage loss (Vrms, dB)

30
25
Smooth electrode surface

20
15
10
Porous
electrode surface

5
0

10

100
1000
10,000
Frequency of stimulation, f (Hz)

Figure 6.10 Pacing voltage loss at the myocardiumelectrode interface is reduced by

implementingaporousasopposedtorelativelysmoothtippedelectrode.Decreaseinvoltageloss
islargelycontributed tobydecreasedelectrodepolarizationassociated withincreasedactive
surfacearea.FromSchaldach,M.M.1992.Electrotherapyoftheheart.Berlin:SpringerVerlag.

Electrode housings are typically comprised of silicone rubbers or

polyurethanes.Allofthesematerialsarediscussedindetailinsection6.3.
Steroidelutiontechniques
The application of pharmacological antiinflammatory agents at the interface
between myocardium and an electrode can significantly reduce both acute and
chronic increase in stimulation threshold. Acute inflammation can contribute
significantly to energy loss during the first one to four weeks following
implantation.Variousdrugelutingelectrodeshavebeenextremelysuccessfulin
maintaining lowenergy losses for both pacing and sensing by reducing
postimplantation inflammation (Mond et al., 1988; Mond and Stokes, 1991;
Stokes,1988;StokesandChurch,1987).

ELECTRODES,LEADS,ANDBIOCOMPATIBILITY

148

Figure6.11showsasteroidelutingelectrode.Itisacrosssectionalviewof
thesameMedtronicCapSureelectrodeshowninFigure6.1.Notethatwhilethisis
indeedasteroidelutingdesign,italsoexhibitstraditionaldesigncharacteristics
discussedintheprecedingthreesections.Itstipisnearlyhemisphericalandhasa
geometricareaofapproximately8mm2.Inaddition,itusesaporous,platinum
coated titanium surface to increase the active surface area while reducing tip
incompatibility.Whilesteroid elution is animportantadvancementinelectrode
technology, previously discussed design criteria are still important (Mond and
Stokes,1991).
TheelectrodeshowninFigure6.11hasbehinditsporoustipasiliconerubber
plug(knownasthe monolithiccontrolledreleasedevice)filledwithslightlyless
than1mgofdexamethasonesodiumphosphate(DSP)(MondandStokes,1991).
When exposed to tissue, the drug elutes through the porous surface into the
surrounding electrodemyocardial interface. DSP is a member of the potent
antiinflammatory pharmacological family known as glucocorticosteroids. Many
glucocorticosteroidsareknowntosuppressinflammation(Mondetal.,1988;Mond
andStokes,1991).

Electrode body

Porous, platinum
coated titanium tip

Silicon rubber
plug (impregnated
with DSP steroid)
Figure 6.11 Crosssectional view of a steroideluting intracardiac electrode (Medtronic
CapSureelectrode,model4003).Notesiliconerubberplugwithimpregnated steroidDSP.
Steroidelutesthroughtheporoustipintosurroundingtissue,thusreducinginflammation.From
Mond, H., and Stokes, K. B. 1991. The electrodetissue interface:the revolutionary role of
steroidelution.PACE,15:95107.

While glucocorticosteroid chemical mechanisms are not yet completely

understood,theirsuccessistheorizedtobetheresultofsuppressionofearlyand
latestagesofinflammation(StokesandBornzin,1985).Recallfromsection6.1.2
thatphagocyticcellactivityaroundtheelectrodetipcausesreleaseoflysosomal
inflammatorymediators.DSPisbelievedtostabilizethemembranesofphagocytes
byalteringtheirpermeability,thusdecreasingtheirtendencytoreleaselysosomal

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DESIGNOFCARDIACPACEMAKERS

inflammatorymediators(Henson,1971;Henson,1980;PrestonandJudge,1969).
Reductionofinflammatorymediatorreleasecanthereforereduceinflammation.
Other implementations of steroideluting intracardiac electrodes have also
beendeveloped.SeveralcompaniessuchasMedtronicandTelectronicsandCordis
PacingSystems[TelectronicsandCordisPacingSystems,Sydney,Australia]have
implementedexternaldrugreleasingceramiccollarsaroundsomeelectrodetips.
Asdiscussedinthenextsection,atrialpacemakerelectrodesarecommonlyactively
fixedtotheheartssurface.Modernactivefixationmethodsoftenusemethods
whereahelicalcorkscrewtipistwistedintotheatrialwall.Byplacingapermeable,
drugreleasingcollararoundthehelicalscrew,steroidisabletoflowintothetissue
directlysurroundingthescrewtip.Decreaseinstimulationthresholdsexhibitedby
collarsteroidelutingelectrodeswhichalsocommonlyimplementtheDSPsteroid
concurstronglywiththosefoundinotherdrugelutingdesigns(Breweretal.,
1988).
Steroidelutingdesignsimplementedinseveralmodernpacemakerelectrodes
provide an effective method of maintaining low acute and chronic stimulation
thresholds. While technology is relatively new, glucocorticosteroid elution into
tissuesurroundingtheelectrodetiphasalreadyproventobesuccessful.
Electrodeimplantationandfixation
Reliable electrode fixation near or into myocardium is critical to effectively
interfacethepulsegeneratorandtheheart.Implantationofapermanentpacing
electrodeisgenerallydesiredtoendurethelifetimeofthepatient.Inrarecases,
cardiologistsconsiderwithdrawaloftheelectrodeduetoinfection,thrombosis,or
cardiacdysfunction.Whilefixationshouldwithstandthenaturalmechanicaland
chemicalconditionswithintheheart,reasonableeaseofremovalisdesirableifthe
electrodeinducesmorecomplicationsthanitresolves.
There are three general categories of electrode fixation. The first group
consistsoffloatingleads.Electrodesontheseleadsarenotactuallyattachedto
hearttissueatall.Instead,theyfloatinsidetheheartschambers.Complications
attributedtoleadmovementandstrayingstimulationcurrentmakefloatinglead
implementationslesschronicallydesirablethanelectrodeshavingdirectornear
contact with myocardium. Floating leads are therefore most often utilized in
temporarypacingsystems.
A more reliable method of attaching pacemaker electrodes is via active
fixation.Therearecurrentlythreetypesofactivefixation:sutured,barbed,and
helical. Sutured fixation commonly requires openheart surgery. An epicardial
electrodesuturepadoftenhavinganactiveelectrodeatitscenterisactually
sewndirectlyontotheepicardialtissue.Thisprocedure,althoughnotcommon,is
prescribed most typically for children, whose physical growth increases lead
tensionandtugsatimplantedelectrodes(Gilletteetal.,1985;Karpawichetal.,
1992;Williamsetal.,1986).Barbedfixationisanalogoustoa fishhook andalso
requiresanopenheartprocedureforimplantation.Abarbed,metalelectrodetip

ELECTRODES,LEADS,ANDBIOCOMPATIBILITY

150

initiallyplacedagainsttheendocardiumispulledorpushedintothetissue,thus
renderingitimmobile.Itmayormaynotbesurgicallysuturedfurtherinplace.
Helicalactivefixationelectrodesincorporateoneormorehelicalscrewsatthe
tipthatarerotatedintothemyocardialtissue.Electrodesusinghelicalfixationcan
beimplantedtransvenouslyandhavethereforebecomeclinicallypopularforactive
fixation(Charlesetal.,1977;Gilletteetal.,1985;StokesandStephenson,1982).In
addition, if the lead must be clinically removed, a physician is able to simply
unscrewtheleadfromthemyocardiumandwithdrawit.Thescrewmayormaynot
be implemented as the electrodes pacing/sensing region. Helical fixation
electrodesarecommonlyusedforatrialimplantationprocedurestoaccommodate
theleadbendingrequiredforintroductionintotherightatrialwall.Suchfixation
intomyocardiumdecreasestheopportunityforlateralforceexertedbytheleadto
dislodgetheimplant.
However, transvenously passing sharp helical tips during implantation
proceduressometimescausesinherentclinicalimplicationssuchasslicingveinsor
excessively puncturing heart tissue. Problems associated with fixed helical tip
implantationhaveledtothedevelopmentofbothretractableandcoatedhelical
fixationelectrodes(Charlesetal.,1977;Gilletteetal.,1985;Ormerodetal.,1988).
Retractable helical tips have rotational mechanisms within the lead to permit
rotationofapinexternaltotheincisionsitetoretractthefixationscrew.Theleadis
thenabletobesafelypassedtransvenouslyintotheheart.Onceintheheartand
readytobeimplanted,aphysicianisabletoreextendthescrewandtwistitinto
place.
Therearetwodisadvantagesassociatedwithmanyretractabletipdesigns.The
firstistheincreasedleaddiameterrequiredtoaccommodaterotationalapparatus
andprotectionofleadfilamentcoils.Inaddition,leadflexibilityisalsodecreased
(Cameron et al., 1990; Ormerod et al., 1988). Section 6.2 discusses the
physiologicalimplicationsofbothofthesedesigndisadvantages.Coatedhelical
tips,however,permitlesshazardoustransvenouspassagewithouthavingrotational
apparatus incorporated into the lead (Ormerod et al., 1988). A nonretractable
helical screw is encapsulated with a biocompatible gel that dissolves after
implantation,thusmakinginsertionandhandlingmuchsimplerandlessdangerous
thanothernonretractablemodels(Ormerodetal.,1988).
Allthreeactivefixationmethodsresultinextremelylowdislodgementrates
(oftenlowerthan1%ofthetotalnumberofimplantations).However,invasively
puncturing heart tissue via active fixation is theorized to induce increased
inflammation.Ithasalreadybeendeterminedthatsuchanincreasereducespacing
efficiency.
Athirdmethodofimplantingpacemakerelectrodeshasalsobeendeveloped:
passivefixation.Passivelyfixatedelectrodesutilizenaturaltissueencapsulationof
theirphysiologicallyforeignmaterialstoanchorthedevicesinplace.Theydonot
puncturethemyocardiumtheygentlylieagainsttheendocardiumverynearthe
myocardium.Thisreducesinflammation.Severalmechanismshavebeendeveloped
to promote tissue passive fixation, including:wings, crowns, flanges, bristles,
projectingwires,andtines.Oftenthesefixationdevicesarecomprisedofpolymers
duetotheirrelativebiocompatibilityandflexibility.Whileactivefixationmethods

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DESIGNOFCARDIACPACEMAKERS

still exhibit lower dislodgment rates, improving technology contributes

significantlytoincreasingpassivefixationreliability(MondandSloman,1980).
Varioustinedfixationimplementationscurrentlyexhibitthemostpassivefixation
clinical success, exhibiting dislodgement rates averaging between 34%. These
designstypicallyincludethreeormoretinesinavarietyofconfigurationssuchas
helicallywoundaroundtheelectrodebody,symmetricallyspacedinoneormore
rowsspanningthelengthoftheelectrodebody,andothers.
Figure6.12showsvariousexamplesofactiveandpassivefixationelectrodes.

(a)

(b)

(c)

(d)

Figure6.12Examplesofactiveandpassivefixationelectrodes.(a)Epicardialsuturepadactive
fixationwithdiskshaped,steroidelutingplatinizedporousplatinumelectrodeincenter(From
Medtronic, Inc.); (b) Barbed epicardial polished platinum fishhook electrode (Medtronic
model6917A,FromMedtronic,Inc.);(c)Helicalactivefixationelectrode;(d)Tinedpassive
fixationelectrode(BIOTRONIC,Inc.modelDJP/JP,FromBIOTRONIC,Inc.).

6.2LEADS
Leads are an important component of a pacemaker system. While commonly
addressedsimultaneouslywithelectrodes,manyleaddesigncriteriadifferfrom
thoseofelectrodes.Permanentpacemakerelectrodesaredesignedtoremainina
fixedpositiononceimplanted.Thelead,however,mustbeabletoflexandpossibly
growwiththepatient.
Leadsareoftenthreadedthroughvesselsoftheuppervenoussystemintothe
hearttoavoidopenheartprocedures.Theymustthereforehavediametersthatdo
notoccludeandbecomprisedofmaterialsbiocompatiblewiththecardiovascular
system.Similartoelectrodes,leadsareusuallyintendedtolasttheremainderofa
patientslife.Devicelongevityrequiresdurabledesignwhichmaycompromise
invasivenessandbiocompatibilitycriteria.Recentadvancementsinleadtechnology

ELECTRODES,LEADS,ANDBIOCOMPATIBILITY

152

have incorporated many effective compromises between flexibility,

biocompatibility,anddurability.
6.2.1Leadrolesinpacingsystem
Thepacemakerleadoftenfulfillstworoles:(1)deliveringstimulationpulsesfrom
thepulsegeneratortotheelectrodeand,ifimplemented,(2)deliveringelectrogram
signalssensedbytheelectrodetothepulsegenerator.
Figure6.13showstwogeneraltypesofmodernpacemakerleads:unipolarand
bipolar.Unipolardesignsonlyrequireoneleadconductor(knownasacoil).The
stimulatingcathodeisattachedtothedistalendofthelead.Thepacemakercasing
isoftenutilizedastheanode.Anadvantageofunipolarimplementationsincludes
simple,singlecoiltechnologylesspronetoclinicalandmanufacturingdifficulties.
Inaddition,unipolarleadsaretypicallythinnerthanbipolardesigns(becausethey
haveonlyonecoilasopposedtobipolarstwocoils).Unipolarleadssometimes
appeartoinducelessinflammationthanbipolarmodelsbecausebipolarleadsare
stifferandresultinincreasedpressureoncardiactissue(Cameronetal.,1990;
Jacobset al.,1993).Inaddition,leadcompressiondamageattributedtomedial
subclavian caudal traction is commonly reduced in unipolar leads because of
increased flexibility (Cameron et al., 1990; Jacobs et al., 1993; Magney et al.,
1993).

Atrial J-shaped

Atrial J-shaped

Ventricular

Ventricular

Unipo lar

Bipo lar

Figure6.13 UnipolarandbipolarimplementationsofbothJshapedandnonpreshapedleads.
Allmodelshavedistalcathode.Bipolardesignstypicallyhavearinganodeproximal1015mm
onthelead.

Bipolar leads also have distal cathodal electrodes. In addition, each also
typicallyhasaringanodethatfloatsintheheartcavityproximalonthelead.The
distancebetweenthesetwoelectrodesvariesbyleadmodelfromapproximately
1015mm.Bipolarleadsofferseveralpotentialadvantagescomparedtounipolar
designs,including:reductionoffarfieldpotentialamplitudes(Aubertetal.,1986;
DeCaprioetal.,1977;Griffin,1983),relativeimmunitytoexternalinterferenceand
myopotentials (Antoniucci et al., 1981; Breivik et al., 1983; Daley and White,
1982;Levineetal.,1982;LevineandKlein,1983;Secemskyetal.,1982),signal

153

DESIGNOFCARDIACPACEMAKERS

tonoiseratioimprovement(Aubertetal.,1986;DeCaprioetal.,1977;Griffin,
1983),anddecreasedskeletalmusclestimulation(Cameronetal.,1990).
Aphysiciantypicallydecideswhichtypeofleadisinthebestclinicalinterest
of his or her patient (Hayes, 1992). Due to lifestyle variances, different lead
configurations are implanted in different people. Clinical advantages of bipolar
leads commonly outweigh the advantages offered by unipolar designs (Hayes,
1992). Bipolar leads have been made even more clinically desirable as
technologicaladvancementshavemadethemthinnerandmoreflexible.In1989,
76% of nonsurgeons and 60% of surgeons preferred bipolar configurations
(BernsteinandParsonnet,1989).However,pacingandsensingdifferencesbetween
thetwodonotdramaticallydiffer.
6.2.2Leadimplementationcharacteristics
There are several characteristics important to successful implementation of
pacemakerleads.Fromanelectricalperspective,leadconductancedirectlyaffects
both the systems pacing efficiency and ability to accurately sense electrogram
signals. The material, thickness, and the length of lead conduit contribute to
resistanceinducedlosses.Inaddition,durabilityoftheleadsisimportanttooverall
device reliability. Stiffness of a lead is important for two reasons: ease of
implantation and electrode efficiency. Stiffness is generally determined by the
insulationmaterial,coilmaterials,andcoilconfiguration(unipolarversusbipolar).
Leadinsulationmustbebiocompatibletoreducepathologicaleffectsthatcould
possiblyinducethrombi,emboli,orinfectionofthecardiovascularsystem.Lastly,
toavoidincreaseinleadresistanceduetocorrosion,insulationmaterialmustbe
bothdurableandflexible;itcannotwearawayinthebloodstreamorcrackunder
repeatedflexion.
Reducingleadvoltageloss
Voltagelossinaleadisreducedbydecreasingcoilresistance.Coilresistanceis
determinedbytheexpression:
RL

L
(6.15)
ac

whereisthecoilmaterialsresistivity,Lthecoilfilamentstotallength,andac
thecoilfilamentscrosssectionalarea.Onewayleadresistancecanbeloweredis
by shortening its length. However, lead length is determined primarily by the
physicalcharacteristicsofthepatient.Especiallyinchildren,extraleadlengthmust
becoiledsomewheretoaccommodatebothbodilyflexionandphysicalgrowth.In
child implantation cases, researchers are now able to determine within 95%
accuracyhowtallachildpatientwillbecome.Thus,excessleadallocationcanbe
made(OSullivanetal.,1993).Forbothchildrenandadults,patientsarecommonly
requestedtomaximallyinhale,exhale,andexertbodilymovementstypicaltotheir
lifestyles. From both expected height information and allowance required for

ELECTRODES,LEADS,ANDBIOCOMPATIBILITY

154

physicalmovement,requiredleadlengthcanbedetermined.Whileextralengthcan
becoiledbehindthepulsegeneratoritself,considerablebulkaddedtotheimplant
resultingindecreasedcosmeticdesirabilityandincreasedriskofleadextrusion
makethisalessattractiveoption(OSullivanetal.,1993).Excessleadlengthis
nowcommonlyloopedintherightatrium(OSullivanetal.,1993).
Another method of lowering lead resistance is by choosing coil material
havinglowresistivity. Leadcoilsarecommonlymanufacturedfromcobaltbased
alloyssuchasMP35N(35%Co,35%Ni,20%Cr,10%Mo)havingsilverfilled
coresduetotheirextremeflexibilitiesandlowresistivities.Inaddition,theyarenot
difficulttomanufactureorconsistentlycoil(Cameronetal.,1990).
Leadreliability
Leads must beable tostretch andbendwith thepatient.Toenable elongation
capabilityanddurableflexibility,thefilamentsofaleadaretypicallycoiled.Axial
elongationsandflexionsof15%havebeenreportedtowithstandupto200million
cycle durability tests with no decrease in lead performance (Adleretal.,1992).
Thisiscriticaliftheleadistoreliablyenduretheremainderofapatientstherapy
term.
Leadimplantationapparatus
Inadditiontoprovidingflexibilityandelongationcapabilities,variousleadcoil
configurationsalsoprovidealumenforinsertionandextractionofdevicesknown
asastylets.Firmstyletsareusedinimplantingandremovingpacemakerleads.In
some designs, the lead is already preshaped to accommodate the location into
which it will be introduced (often Jshaped for upsidedown introduction of
electrodeintorightatrium).Insuchapreshapedlead,astraightstyletmustbe
insertedthroughthecoillumentoallowvenoustransversalduringtheimplantation
procedure. In other leads, the lead itself is not preshaped and passed directly
throughaveinintotheheart.Ifrequired,apreshapedstyletmaythenbeinsertedto
permitandmaintainthedesiredleadshapeforeffectiveelectrodeenlodgmentuntil
itisremoved,ifever.
Leadtesting
Common measurements of lead durability include: general lead reliability, flex
fatigue,styletinsertionandextraction,vibrationtesting,andleaktesting.General
leadreliabilityisusuallydeterminedbytheabilityoftheleadtotoleratenormal
stressesinducedbyhandlingandimplantation.Flexuraltestingdetermineshow
wellaleadperformsbothelectricallyandphysicallyafterrepeatedflexingand
elongation.Styletinsertionandextractiontestsdetermineifaleadisphysicallyor
electrically damaged by multiple stylet insertions and removals. Vibrations
attributedtomanufacturing,shipping,andhandlingprocessesmayalsocontribute
toleaddeficiencies.Variousvibrationtestsareoftenperformedonmultipleaxesto

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DESIGNOFCARDIACPACEMAKERS

determineif aleadcanwithstandsuchconditions.Leaktestingisimportantto
determineifleadinsulationandjointscanwithstandchemicalconditionssimilarto
thosefoundinthebody.
Aftermostleadtestshavebeenperformed,electronmicroscopescans(EMS)
are routinely performed to determine coil integrity. Figure 6.14 shows two
examplesofcoildeformationcommonlyattributedtocompressioninducedbythe
scissoringeffectbetweenapatientsclavicleandfirstribuponanimplantedlead
(Brinker et al., 1991; Stokes and McVenes, 1988; Stokes et al., 1987). The
procedureusedtoimplantleadsexperiencingsuchdeformationsisknownasthe
percutaneoussubclavianveinapproach.Thisprocedurehasrecentlyaccountedfor
between7595%ofpacemakerleadimplantations(BernsteinandParsonnet,1989).
Whileclinicaleaseandspeedofimplantationhaveaccountedforthepopularityof
thisprocedure(Hesset al.,1982;Jacobsetal.,1993),increaseincoilfracture
occurrenceattributedtorepeatedscissoringcompressionhaverequiredevaluation
ofboththeimplantationprocedureandleaddesign(Altetal.,1987;LuckandPae,
1991).

(a)

(b)

Figure6.14Examplesofcompressedleads.(a)Compressiondamagetosoftwirecoilaftera
single application of compression in medial subclavian implantation. (b) Coil fracture
morphologyassociatedwithrepetitiveandcompressivescissoringbetweenapatientsclavicle
andfirstrib.FromJacobs,D.M.,Fink,A.S.,Miller,R.P.,Anderson,W.R.,McVenes,R.D.,
Lessar,J.F.,Cobian,K.E.,Staffanson,D.B.,Upton,J.E.,andBubrick,M.P.1993.Anatomical
andmorphologicalevaluationofpacemakerleadcompression.PACE,16:434444.

Leadstiffness
Lead stiffness is important to both ease of clinical insertion and electrode
efficiency.Ifaleadistoostiff,transversalofitslengthismadedifficultasthe
physicianattemptstorunitthroughoneofseveraluppervenoussystemveins.
Althoughrare,clinicalcaseshavebeenreportedofelectrodespiercingvesselwalls
due to overly stiff leads. Additionally, once an electrode has been implanted
(whetheractivelyorpassively),minimalpressureshouldbeexertedagainstthe
endoandmyocardium.Thisminimizesmechanicallyinducedinflammation.Ifa
bent lead excessively pushes its electrode against the heart tissue, increased

ELECTRODES,LEADS,ANDBIOCOMPATIBILITY

156

inflammationresultsinreducedpacingefficiency.Ifaleadisextremelystiffor
improperlyimplantedinapatientwithdeficientmyocardialtissue,thepatientmay
experiencemoresevereconditionssuchashighthresholdexitblock,myocardial
ischemia,orventricularperforation(Cameronetal.,1990).
Bipolar leads are traditionally known to be stiffer than unipolar
implementations(Cameronetal.,1990).Whilethedistallengthbetweentheanode
andcathodeisstructurallythesameaswithaunipolarlead,abipolarleadoftenhas
a pair of coaxial coils comprising the remainder of its proximal length. This
increasedbulkcansignificantlyincreaseleadstiffness.Intermedicshasintroduced
athinbipolarleadhavinggreaterflexibilitythanobservedinmanyotherbipolar
designs (Adler et al., 1992). Figure 6.15 shows both traditional coaxial and
IntermedicsThinLineleadmodels.

PICfrom(15,11,1987).

Figure6.15ComparisonoftraditionalcoaxialbipolarcoilconfigurationwithIntermedics,Inc.
ThinLinedesign.NotethattheThinLineleadissignificantlythinnerthanastandardbipolarlead.
Thisresultsinincreasedleadflexibilityandlessinvasiveness.FromAdler,S.C.,Foster,A.J.,
Sanders,R.S.,andWuu,E.1992.Thinbipolarleads:asolutiontoproblemswithcoaxialbipolar
designs.PACE,15:19861990.

Leadinsulation
Another leadconsiderationisinsulationmaterial.Importantcriteriatoselecting
thesematerialsinclude: electricalinsulation properties,stiffness,durability,and
biocompatibility.Twoclassesofmodernmaterialshavebeenfoundtosatisfactorily
exhibitmostofthesecharacteristics:polyurethanesandsiliconerubbers.Bothare
excellentelectricalinsulators,verydurable,andarerelativelybiocompatible.Many
polyurethanesusedasleadinsulationarelessflexiblethansiliconerubbersandthus
can contribute to the overall stiffness of the lead (Cameron et al., 1990). In
addition,studiesinrecentyearsdemonstratehigherratesofinsulationcrackingfor
leads using polyurethanes than those implementing silicone rubbers. However,

157

DESIGNOFCARDIACPACEMAKERS

polyurethanes have lower friction coefficients than silicone rubbers and are
thereforeeasiertoimplant.Theadvantagesanddisadvantagesofpolyurethanesand
siliconrubberasleadinsulationhavebeenasourceofdebateforyears.

6.3BIOCOMPATIBILITY

Itisimportantthatanythingimplantedinthepatientnotcompromiseotherwise
previoushealthybodysystems.Protectingthepatientfromadversematerialside
effectsistheprimarygoalofbiocompatibility.
Asecondarygoalisprotectingpacemakeroperationfromthebodyshostile
environment. This is known as biostability. The human body exerts multiple
processestoeitherdestroyorisolateforeignmaterialsfromitsotherwisenormal
physiologicoperation.Ifmaterialsarechosenpoorlyornotmanufacturedproperly,
foreignbodyprocessesmayenterandpossiblycorrupttheintegrityofanyorall
pacemaker components. To maintain effective pacing therapy, therefore, body
fluidsmustbekeptfromenteringanycomponent,joint,orsealintheentiresystem.
6.3.1Characteristicsofpacemakerbiomaterials
There are no known entirely biocompatible materials. When implanted, all
materialsundergovarioustypesanddegreesofchemicalinteractionswithbodily
solutions.Itisimportant,therefore,tofindsuitablematerialsforspecificbiological
applications.Suchmaterialsaredefinedbythefollowing:
Amaterialofoptimalbiocompatibilityisonethatdoesnotleadtoanacute
or chronic inflammatory response and that does not prevent a proper
differentiationofimplantsurroundingtissues(Williams,1987).
The tissues affected by the three pacemaker componentsthe pacemaker,
lead,andelectrodealldiffer.Thepacemakeritselfisusuallypocketedbetweena
patientsskinandpectoralmuscle.Aleadtypicallytransversesthesubclavianor
cephalicveinintothesuperiorvenacava.Theelectrodeisimplantedintotheright
atriumorventricle.Itisimportanttoselectordevelopmaterialscompatiblewith
therespectiveimplantlocationscharacteristics.
From these three locations (skin/muscle, venous, and inner heart), two
different pacemaker material groups are distinguishable: soft tissue and blood
compatiblematerials.Foreach,severalcharacteristicsneedtobeconsideredfor
implantation: physical, mechanical, chemical, electrochemical, physiological,
pathological,andbiological.Manufacturability,qualitycontrol,andcostreduction
are also criteria important for mass production. Compromises made between
physicalandproductioncriteriadetermineapacemakersystemsbiocompatibility
success.

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158

Physical andmechanical materialcharacteristics include:density, hardness,

flexibility,tensilestrength,gaspermeability,shearmodulus,electricalandthermal
conductivity,thermalcoefficientofexpansion,andsurfaceroughness(Billmeyer,
1984; Brown, 1988; Fraker and Griffin, 1985; Mohtashemi and Hines, 1983;
RembaumandShen,1971;SchaldachandBolz,1991;Shalaby,1988;Szycher,
1983; Williams, 1987). Pacemaker materials must be able to withstand various
physical,mechanical,andchemicalelementsfordecades.
Generally,thebodyischemicallymodeledasasalinereservoircomprisedof
manydifferentions.Itisalsocomprisedofelectrolytes.Thesecharacteristicsmake
the pacemaker system vulnerable to a variety of chemical and electrochemical
interactions.Reducingopportunityforpacemakersystemmaterialstonegatively
affectthebodyandviceversarequiresseveralchemicalparameterconsiderations.
These include: corrosion resistance, chemical stability, resistance to chemical
solvents, sterilizability, water absorption, and surface tension characteristics
(Billmeyer, 1984; Mohtashemi and Hines, 1983; Rembaum and Shen, 1971;
SchaldachandBolz,1991;Szycher,1983;Williams,1987).
Chemicalandelectrochemicalreactionsoccurringatmaterialtissueinterfaces
ofteninducephysiologic,pathologic,andbiologicchanges.Clinicalconsequences
oftheseinteractionsrequirethatpacemakerdesignersalsoconsidermaterialcriteria
directly relevant to patient health. These clinical considerations include:
carcinogenicity,toxicity,thrombogenicity,immunalresponses,infectionaffinity,
andallergicandinflammatoryreactions(MohtashemiandHines,1983;Schaldach,
1992;SchaldachandBolz,1991).
Commoncomplicationsattributedtopacemakermaterialsandimprovements
requiredtoforcomplicationreductionareshowninFigure6.16.
Complications
Thrombosis
Blood traumatization
Tissue reaction

Future development
action items
Antithrombogenic surface
Blood compatible materials
Improved construction

Fibrosis
Corrosion and degradation
Products of abrasion
Infection

Inert, noncorrosive
materials
Atoxic materials

Metabolic changes
Figure 6.16 Common complications attributed to pacemaker materials and goals for future
development. From Schaldach, M. M. 1992. Electrotherapy of the heart. Berlin:Springer
Verlag.

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DESIGNOFCARDIACPACEMAKERS

6.3.2Summaryofpacemakerbiomaterials
There are four general classes of biomaterials: metals, polymers, glasses, and
ceramics.Therearealsocompositesofthesematerials.Allareknownasbeing
alloplastic,meaning not biological inorigin. Thechemicalbondsholding each
materialtogethergenerallydetermineimplantationutility.
Metals
Metalstypicallyexhibitbondscharacterizedbyfreeelectronsinalatticeofpositive
atomic cores. These bonds and their free electrons contribute to the electrical
conductivityofmanymetals(Brown,1988;FrakerandGriffin,1985;Schaldach,
1992;Szycher,1983;Williams,1987).Inaddition,metallatticescontributetotheir
relativestrength,flexibility,andhardnesscomparedtoothermaterials.Titanium
andtwoofitsalloys,niobiumandtantalum,areespeciallybiocompatiblebecause
they spontaneously form nonconducting oxide layers at their surface (such as
TiO2).Thisprovidesaprotectivesurfacepreventingexchangeofchargecarriers
acrossthephaseboundary(Frakeretal.,1980;ZitterandPlenk,1987).Platinum
and/or iridium coated electrode tips have exhibited low chronic stimulation
thresholds duetoreducedlocalinflammation (Mondet al.,1988;Rubinetal.,
1991;Schaldachetal.,1990).Titaniumanditsalloysalsoexhibitphysicaland
mechanical properties equivalent or superior to many other metals (Schaldach,
1992).Themodulusofelasticityoftitaniumanditsalloysrangebetween100
120GPa. Extreme resistance to corrosion and durability make titanium and its
alloys ideal materials for hermetically sealed pulse generator cases (Schaldach,
1992; Tarjan and Gold, 1988). These cases are now commonly laser welded
together.
Othermetalsimplementedinpacemakercomponentshaveincludedvarious
stainless steels(suchastype316L),cobaltandchromiumalloys,platinumand
someofitsalloys,nonferrousalloyssuchasMP35N[StandardPressedSteel],
Elgiloy [American Gage and Machine], and Tinel/Nitinol [Raychem], and
iridium(Bittence,1983;BoretosandEden,1984).Inadditiontotitaniumandits
alloys,variousstainlesssteelshavealsobeenusedforbothpacemakercasesand
lead coils. Cobalt, chromium, silver, and nonferrous alloys are also commonly
implementedasleadcoilconduitduetoelectricalandflexuralproperties.Platinum,
iridium, and Elgiloy are commonly used for electrode tips due to high
biocompatibility. While these materials are generally not as biocompatible as
titanium and its alloys, they suitably fulfill requirements of their respective
biologicalimplantationsites.
Polymers
Polymers,orplastics,arecommonlyusedasleadinsulation,electrodehousings,
electrodecasesealants,andforbondingleadcomponents.Inaddition,theyarealso
usedforelectrodefixationapparatusandformingtheconnectorblockbetweenthe
pulsegeneratorandthelead.Polymersarecharacterizedbyelongatedmolecular

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160

structurescontaininglargequantitiesofcovalentlybondedcarbongroups.Dueto
bondingcovalency,manypolymersexhibitverylittlechemicalinteractionwiththe
body.However,becauseofthelengthofsomeoftheirmolecularchainsandthe
bondsthatholdthemtogether,polymermechanicalpropertiesareoftendependent
upontemperature(Billmeyer,1984;RembaumandShen,1971;Schaldach,1992;
Szycher, 1983). Thus, properties such as: hardness, flexibility, and thermal
coefficient of expansion are specifically of concern. Additionally, due to
petroleumbased manufacturing processing, polymer materials often have
carcinogenicityandtoxicityconsiderations.Despitethesepossibledisadvantages,
polymer materials are generally cheaper and available in forms more easily
manufacturablethanmostbiocompatiblemetals.Polymersarecommonlyavailable
in granules, pellets, or films. These forms are easily adapted to manufacturing
processessuchasextrusion,injectionmolding,orvacuumcasting.Metalprocesses
suchascutting,grinding,andpolishingarelesscostandtimeeffective.
Common polymers used in pacemaker applications include various
polyurethanes and silicone rubbers. Polydimethyls, siloxanes, and various
polyurethanesareflexible,nonconductive,andabrasionresistant.Theyarealso
easilymanufactured byinjection moldingandextrusion processes.Allof these
characteristics contribute to successful implementation as lead insulation and
electrode housing materials (Llewellyn et al., 1988). Epoxy resins and silicone
rubbers exhibit five advantageous pacemaker material characteristics, including
being chemically resistant, exhibiting low shrinkage in warm, aqueous
environments, strong adherence to metals, extremely flexible, and easily
manufacturable in molding processes. Such resins are thus commonly used in
pacemakersystemjointsandconnectors,especiallythepulsegeneratorconnector
block (Billmeyer, 1984; Rembaum and Shen, 1971; Schaldach, 1992;
Szycher,1983).
Glassesandceramics
Glassesandceramicsareextremelyhardandexhibitdesirablepropertiesrelevant
tothermal coefficientsofexpansion,specificheats,insulation,andsmoothness.
There are several pacemaker uses for glasses and ceramics. One use includes
ceramicencapsulationofthepulsegeneratorforprotection.Thissealantlayeris
extremelysmoothandverysofttissuebiocompatible.Ceramicsorglassesarealso
sometimesactivatedwithmetalsorvitreouscarbontoproducehighactivesurface
areas desirable for electrode tips (Katsumoto et al., 1986; Mund et al., 1986;
Schaldach,1992).Duetoabsorptioncharacteristics,ceramiccollarssurrounding
electrode tips have been used for containment and elution of steroids into
surrounding tissue to minimize inflammation and collagenous accumulation
(Anderson et al., 1990; Anderson et al., 1991; Mathivanar et al., 1990;
Skalskyetal.,1990;Wilsonetal.,1991).Lastly,glassiscommonlyusedtoboth
seal pulse generator can entry and comprise the connector block where lead
connectionoccurs.

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6.5INSTRUCTIONALOBJECTIVES
6.1

Statethetwomostcommon electrical roles ofapacemaker electrode. Explainbriefly

whichismostimportanttoextendingpacemakerdurationofserviceandwhy.
6.2 ExcludingelectricalrolesrequestedinInstructionalObjective6.1,listsixconsiderations
importanttoelectrodedesignphysically.Explainbrieflywhyeachisimportant.
6.3 SketchthefirstorderapproximationoftheHelmholtzdoublelayerformedbymetalbeing
submersed in electrolyte. Include electrical schematic model correlated to exhibited
physicalcharacteristicsofthisdoublelayer.Whyismetaloxideformationdesirable?
6.4 Explainwhyreversiblereactionsarepreferabletoirreversiblereactionsattheelectrode
electrolyte interface. Explain briefly two possible ways that reversible charge transfer
(RCT)isobtainedatthisinterface.
6.5 DiscusstheoriginofFaradiccurrent.WhyisFaradiccurrentundesirable?
6.6 Explainwhythesuppressionofelectrodeinducedinflammationisimportanttodecreasing
bothacuteandchronicstimulationthresholdchange.Explainbrieflyhowsteroideluting
designsaretheorizedtoaccomplishthis.
6.7 Describethedifferencebetweenelectrodetip macroscopic sizeand microscopic surface
area.Explainwhythedifferenceisimportanttoelectrodetipdesign.
6.8 Explainwhyporosityisimportanttoelectrodetipdesign.Discussthetheorybehindits
success.
6.9 Listtwogeneraladvantages toactivehelicalfixationmethods.Withrespecttopacing
efficiency,stateadisadvantageassociatedwithgeneralactivefixationmethods.
6.10 Forageneralventricularelectrodeimplantation,explainwhyapassivetinedelectrode
maybepreferabletoanactivehelicaltipimplantation.
6.11 Sketchbothunipolarandbipolartypesofleads.Listtwoadvantagesforeach.
6.12 Whatisthedifferencebetweenbiocompatibilityandbiostability?Whyiseachimportant?

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6.13 Listfourusesformetalsinpacemakertechnology.Explainwhytitaniumanditsalloysare
soeffectiveintheirrespectiveapplications.
6.14 Discusstwoprimaryconcernsassociatedwithimplantingpolymersinthebody.Listthe
advantagespolymershaveoverotherbiomaterials.Listtwopolymerscommonlyusedin
pacemakertechnologyandtheirrespectiveuses.