ShuntTechnologies

Presentedby DrVivekTandon

Introduction
Controversial topic whichshunt isbest? Confusion howit works? Knowingthe principleswillhelp inintelligent selectionofdevice.

HowShuntswork

History

VPshunt=1908

Cerebrospinalfluid shunt hydrodynamics

CSFisformedbythechoroidplexusinthe ventricles CSFisabsorbedbythearachnoidvilli Circulatorysystem
CSFproductionisbalancedbyarachnoidvilli absorption

Compliancedynamics
Thebrainandskullcontain threeprimarycomponents:
BrainTissue Blood Cerebrospinalfluid

Compliance =

P V

Achangeinanyoneofthese componentsresultsin adjustmenttotheothertwo Shuntprovidesalowresistance whichiscalledcompliance pathwayforCSFdiversion

ShuntHydrodynamics
Flowrate=P/R P=Drivingpressure R=Resistancetoflow
Resistancefromshunttubing=Rt Lengthandinnerdiameterof thetubing. ViscosityoftheCSF. Rt=8nL/ r^4(Poiseuilleslaw) n=coefficientofabsoluteviscosity. Resistancefromvalvecomponents=Rv. Itsnotconstantintherangeof physiologicflowrates&acurved flowrelationshipisseen.

ShuntResistancesareAdditive

R1 Ventricular catheter R2 Valve R3 Distal catheter

R1 + R2 + R3 = R
R1isnegligible

Hydrodynamicscontd.

Pressureflowcurve

Pressure

Flowrate

Linearpressureversusflowcurveforvalvelesstubingwith constantresistance.

Hydrodynamicscontd.
Thepressuregradientdrivingtheflowina ventriculoperitonealshuntsystemisdeterminedby P=IVP+gh OPV DCP
=density. OPV=openingpressureofthevalve. DCP=distalcavitypressure.

Appliedimportance

Biomaterials
Biomaterialscurrentlyusedinclude: Siliconeelastomer catheters,valvehousings/ sutureclamps,siphondevices,etc. Polypropylene/Polysufone/Nylon/Polyethersulfone valvehousings/seats,needlestops,connectors, reservoirs. Ruby/Sapphire valvepins,balls,seats Titanium/StainlessSteel valvehousings,needle stops Tantalum radiopaquemarkers. Barium radiopaciofier(homogenousorstripe).

ShuntSystems
Shuntsystemscomeinavarietyofconfigurationsand modelsbuttheyhavesimilarfunctionalcomponents:
ValveMechanisms flowordifferential Fixed,programmable,orvariable settings Catheters Ventricular(proximal) Peritoneal/Atria(distal) Accessories Reservoirs,SiphonDevices Connectors,Filters,PumpingChambers

Shuntvalves
Differentialpressurevalves Flowregulatedvalves Gravityactuatedvalves Programmablevalves

Differentialpressurevalve
Slitvalves Mitervalve Diaphragmv.
Definedbytheiropeningandclosingpressure. AstheIVPclimbsabovethevalveopeningpressure, thevalveopenstoallowegressofCSFataratedetermined bytheresistanceofthesystem,untilthepressurefallsbelow theclosingpressureandflowofCSFceases.

Ballinconevalve

Slitvalves
Proximalslitvalves
HolterHausnervalve

Distal slitvalves
Codmanunishuntvalve Chhabrashunt.

Theyoffertheleastresistancetoflowandinfactno significantdifferenceinresistancecanbemeasured betweenatubewithadistalslitvalveandanequallylong openendedtube.

Diaphragmvalve
Mostcommonlyusedtypeofvalve. Involvethedeflectionofasiliconemembranein responsetopressureinordertoallowflowofCSF
Polypropylene (Plastic)Base

SiliconeMembrane (Diaphragm)

Diaphragmvalve

Ceredrain

Medtronicvalve

Medtronic PS Medical CSF-Flow Control Valve, Contoured

BasicValveFeatures
Valvemechanismofdissimilarmaterials
Differentialpressuremechanism
Whenthesumofinletandoutletpressureexceedathresholdvalue,valve opensanddrains

CentralreservoirforpercutaneousCSFaccess Plasticbaseforrigidityandstability Nonmetallicdesign

Pressure/FlowRanges
95mmH20 ICP 95mmH20 Shuntwilldrain ICP 95mmH2O Shuntwillnotdrain

BurrHoleValves

BurrHole (12mmor16mm twistdrillhole)

Skull

Typeofdiaphragmvalve

UltraSmallValve

NeonatalandInfantUse NoInletOccluder SmallerReservoirSize

ButtonValve
Forneonataluse (prematureinfants) Profile:4mm Requiresuseof separatereservoir Nooccluders

DifferentialPressureValve
TheoreticalExample
IntraventricularPressure(IVP) +8cmH20

MediumPressureValve

IVP=10cmH2O IVP(Ventricles) Shunt Drains IVP=8cmH20

DifferentialPressureValve
InReality
+8cmH20
8cmH20(valve)+48cmH20(distal catheter)=40cmH20

MediumValve
IVP(Ventricles) 48cm Shunt Overdrains IVP=40cmH20 Siphoning

Chhabrashunt
Slitvalve

Slitandspringvalve system.
Thesystemsareavailablein2ball,3 ball,4ballrange. Catheterscontainbariumsulfateforx raydetectability. Theventricularcatheterhastantalum tip. Regulatingvalvecontainsastainless steelsleeveandballsandasapphire ball.

FlowRegulatedValves
Contouredsyntheticruby flowcontrolpinthatfits insideamovablerubyring

Asthepressureincreases, therubyringisdeflected downwards,therubyring istaperedtheflowaperture decreaseswhichincreases resistanceandreducesflow.

OrbisSigmaValve

Ifthepressureisfurtherincreasedtherubyringisfurtherdeflecteddown untilresistanceisloweredtoallowrapidincreaseinflowrate.

FlowRegulatedValves
Advantage Flowregulatedvalvesarelesslikelytobe associatedwithsiphoningandoverdrainage

Disadvantages Duetosmallorificehighchancesofobstruction. Highresistancehasapropensitytocausefluid collectionsunderthescalpinyoungchildren unlesstheyarenurseduprightwitha compressivedressing

GravityActuatedValves
Theyattempttoprohibitorreduce siphoningbyincreasingopening pressurewiththeassistanceofgravity. Inletvalve=ballspringvalve anddoesnotchangeresistance withposition

Cordishorizontalverticalvalve

Outletvalvehasasyntheticrubyball thatsitsinaconicalseatandthereare threestainlesssteelballsthatsitontop ofitwhichwieghitdowninuprightpositionandfallawayinrecumbentposition.

Programmablevalves
Theyareexternallyadjustabledifferential pressurevalves. Surgeonhastheoptionofalteringtheopening pressurewithanexternaldeviceandthus alteringtheneedforsurgicalshuntrevision. Theyarealsosusceptibletosiphoning.

Programmablevalves
Theyhaveanadjustableballandspringmechanism.Astepmotorassembly. Radiopaquemarkers. Motorassemblycanbeadjustedwithexternallyappliedmagnets.

Strata Adjustable Delta Valve

Cutaway of Regular Valve

Reservoir
Proxima l O cclude r

Delt a Chamber

Inlet Connector

Valve Me cha nism

Outlet Connector

Basicdesignissameasindiaphragmvalveswithaddition ofamotorassemblyandaspringballmechanism.
IMPLANT THERAPIES
PS Medical

Strata Adjustable Delta Valve

Cutaway of Valve Mechanism

Cassette Ca p Rotor Stop Rotor retention Spring

Cone Ruby Ball Pressure Flow Spring

Magnetic Rotor
Bulleted Feet

Cassette Housing
Performance Level Steps

IMPLANT THERAPIES
PS Medical

Strata Valve Mechanism Exploded View...

Ball & Spring Mechanism

Rotor with Magnet

Five Symmetric Platforms

PlatformStops
Platformstopsinhibitrotor movementfromone platformtothenext Needextrastrongmagnet tolifttherotoroverthe stoptothenewplatform

Platform Stop

Strata Adjustable Delta Valve

Adjustment Tools

Locator Tool

Indicator Tool

Adjustment Tool

IMPLANT T HERAPIES

PS Medical

Strata Adjustable Delta Valve

Preimplantation Adjustment

Position Locator Tool with valve making certain that the flow direction arrows on the valve match the flow on the tool

Position Indicator Tool into the Locator Tool; note that the tools are keyed preventing misplacement. Making sure that the Adjustment Tool is far enough away not to influence readings, record performance level setting

Remove Indicator Tool, and place Adjustment Tool in Locator Tool making sure to align large blue arrow with current performance level setting

Rotate Adjustment Tool so that the arrow points to new desired level. Remove Adjustment Tool

Re-place Indicator Tool and confirm adjustment of new Performance level

IMPLANT T HERAPIES

PS Medical

Programmingtechnique

StrataVarius
Handheldinstrumentdesigned tobeambidextrous Batterypowereddevice(2AA) 100uses Powerdownafter3minutes ofidletime. LCDreadoutscreen Portalforvalvepalpationand magneticadjustment Magnetis2timesstronger

Strata Adjustable Delta Valve

Performance Levels

IMPLANT T HERAPIES

PS Medical

X-Ray Verification
Dot Code

ImageofXRay

Magnet

0.5

1.0

1.5

2.0

2.5

The performance level can be verified by X-ray based on the orientation of the magnet relative to the dot code.

StrataValve ValveAdjustmentReliability
98% ACCURACY RATE
All initial valve settings were confirmed by X-ray All post-operative adjustments were confirmed by X-ray 238 valve adjustments 4 instances where the x-ray did not match patient chart

The 4 discrepancies

CodmanHakim ProgrammableValve

Precision

Programmable

SpringTension
12x Magnification

Spring

Spiral Cam

ValveFunction
Spring Force Programmable Valve Mechanism @ 30 mmH2O

Precision Valve Mechanism @ 40 mmH2O CSF Force

Programmable Valve Mechanism @ 200 mmH2O

HowDoesItWork?

Proximal

Distal

CSF Pressure Builds ...

HowDoesItWork?

Proximal

Distal

Opening the Valve to Drain CSF

ValveProgramming
Top View

Bottom View

Spiral Cam with Steps

Alternating North-South Magnets

ValveprogrammingSystem
AcousticVerification
Acousticsensorembeddedintheprogrammer. Listensforclicks ofthespringonthecam

ProgrammingSteps

Valve Base plate

Programmer Feet

Valveprogrammingverificationsystem
Acousticcommunicationwiththevalve Highdegreeofaccuracy Simplicityforclinicianandpatient

Tradeoffs:
Codman Cannotconfirm preexistingpressuresetting

Strata/Sophy Inabilitytodetect +/ 10mmH2O Increasedmagneticsusceptibility Techniquesensitive

XrayVerification

Thereisadirectcorrelationbetweenthepositionoftheprogramming unitcontrolpanelpressureselectorbuttonsandthepositionof the pressureindicationonthevalvesasseenwhenxrayed. Whenthevalveisprogrammedto70,120,or170,thepressure indicatoralignswiththeX inthecenterofthevalve. ValveCross

MagneticVs.AcousticVerification
MagneticVerification PROS:
Small Intuitive Nopowercords Immediateindicationofcurrent position Increased susceptibilityto magneticfields Imageartifact Inabilitytodetect+ 10mmH2O

AcousticVerification PROS:
Improvedaccuracy Nochangetovalve backwards compatible

CONS:
Requiresreprogrammingvalve Onlyverifiesnewprogrammedvalve settingnotpriorone

CONS:

PerformanceCharacteristics CODMANHAKIM ProgrammableValve vs.STRATAMedtronicvalve

OperatingPressure(mmH2O)

200 175 150 125 100 75 50 25 0

200 190 180 170 160 150 140 130 120 110 100 90 80 70 60 50 40 30

PL 2.5

PL 2.0 PL 1.5 PL 1.0

PL 0.5

ProgrammableValve*STRATAValve

Truepressuresettings,notperformancelevels Tightoperatingranges Higheroperatingpressuresavailable

OpeningPressureAccuracy
225 200 175
Operating Pressure (mm H2O)
+/ 10mmH2O

150 125

145

+/ 25mmH2O

115

100 75 50
40 80

25 0
CHPVw/SG

20

+/ 15mmH2O

StrataValve

MRIStudies
Safeforuse;MRIConditional
nomovementofvalveintissuepocket noselectiveheating noeffectonvalveperformance

MUSTReprogramaftereachMRI MRIwillchangethepressuresetting

MRIArtifact
CHPV Strata

Artifact can be seen Small Effective radius 2.5cm from scalp

Large artifact can be seen Effective radius 5cm from scalp

Sadahiro Nomura, M.D., Yamaguchi University

proGAV
- Design Adjustable in increments of 1 cmH2O between 0 and 20 cmH2O 10 cmH2O = 100 mmH2O Rotor Spring Ballconevalve Spring

TitaniumHousing

1. 2. 3. 4. 5.

Compass AdjustmentPen VerificationPen Masterdisk LocatorTool

Verify

Adjus t

Ease of Use?

proGAVSummary
Adjustingcanbepainfulandyoumustbeprecisewith thetoolstoavoiderrors. LimitedlocationsforimplantingandshuntwithASD mustbeimplantedvertically. Currentlynopublishedclinicalevidenceonlongterm failureorimprovedoutcomes.

Sophysa POLARIS view Safety Bottom

Stops Inlet Connector

Locking Notches Outlet Connector

Bottom view Stop Runn ers Spring

Rotor

Suture Holes Ruby Axis Stop

Radiopaque Press. I.D. points

BODY

Programming Procedure
Magnet Compass Pressureselector Thepressureselector enablesthecompassandthemagnettobe positionedinrelationtothevalve.Theinternalgraduateddial allowsa precisereadingofthe8positionsaswellastheassociatedvaluesof operatingpressure(inmmH2O).Theouterdialoftheselectorshows theprogrammingrangeofthemagnet. Themagnet (1Tesla)providesforadjustmentoftherotor Throughthecompass thereisasimplifiedreadingprocedure:the compasshastobeplacedontheselectortoreadthevalueofthe selectedpressure,inthedirectionoftheredneedle

Sophysadrawbacks
Arigidvalvesystemdoublesinsizewhen Antisiphondeviceisadded LargeSizes,RigidProfilesmaynotbeoptimal forpediatricHydrocephaluspopulation LargeMRIartifactduetoradiopaque markers.

IndicationsforProgrammablevalve

Warnings/Precautions
Valveissuppliedwithoutapresetpressureandmustbe programmedpriortoimplantation Asepticsurgicaltechnique Dontflush,fillorpumpvalvewith lintcontainingfluid Takecaretopreventshuntfromtouchingsurface Donttiesuturestightly Dontmovethetransmitterduringprogramming

Siphoning

Effectsofsiphoning

Topreventsiphoning

Useantsiphondevice

Willonlydelayventricularcollapse Butwillnotpreventit.

MoreResistance

Relationshipis1:1 Foreverycentimeterofchangeoff thereferencepointtheshunt resistancewillbealteredby +/ 1cmH2O

LessResistance

Antsiphondevice

Hasasmalldiaphragmthatreducesthe flowofCSFwhenthepressureinsidethe shuntfallsbelowtheatmosphericpressure

Integra(HeyerSchulte)
AntiSiphonDevice Circa1975

Siphoningcloses diaphragm

Integra(HeyerSchulte) AntiSiphonDevice(ASD)
Afternumerouspublications,theproductis coinedthenameantifunctiondevice by clinicians Allsiliconeconstructionwassubjecttodistortion fromoverlyingtissue. Single,exposed,diaphragmwassubjectto compressionfromoverlyingtissue 8:1HydrodynamicLeverageRatioresultedin increasedshuntresistance

Antsiphondevice

Antisiphondevice

DeltaChamber
TheDeltaChamberusesahydrodynamicleverageratioof20:1to reducetheeffectofnegativehydrostaticpressure,andallowthe valvetooperateinitsspecifiedPerformanceLevel,regardlessofbody posture.
Inletareaaffectedby PositiveIVP

Outletaffectedby distalsiphoning

DeltaValveMessage
TheDeltachambersensesbothpositiveinlet pressure,andnegativeoutletpressure,andmanages both. TheDeltachambermanagesnegativeoutlet pressurewithoutaddingsignificantresistancetothe shunt. Thedissimilarmaterialandrecesseddesignofthe Deltachamberdiaphragmshelptominimizetherisk ofcompressionfromoverlyingtissue.

Siphon/FlowControl
SiphonGuard isauniquedevicedesignedtoreduce theriskofCSFoverdrainagecomplications.
Rugged
Noencapsulationorexternalpressure influence flownottotallyblocked Avoidsdamageduetoerrantneedle

Unaffectedbyimplantlocation Availableasanintegratedorstand alonedevice. Deviceisalwaysopenunlikeother onandoffdevices.

Siphon/FlowControl

NeonatalShuntRequirements
Ventriculostomy Rickham style reservoir Usedinconjunction withavalve Lowprofile Twopieceassembly 6mmburrhole

SnapShuntReservoir
Ventriculostomy Rickham style reservoir Twopieceassembly thatsnaps together

Snap ShuntTool
Availableseparately Reusable Avirginsnapreservoir canbestiffanda platformisneededso pressureisnotapplied totheinfantsskull

ButtonSnapShuntAssembly
AllowsforCSFaccess SnapReservoirsare availableonallvalves styles

Advancementsinbiomaterials
Antibioticimpregnatedshunttubings. Coatedsiliconetubingsforconvertingthem intohydrophilicandmorelubriciousmaterial.

Antibioticimpregnatedshunts

BacteriaInShunting Mostcommonbacteriainshuntinfections? Accountfor Causative organisms of shunt infections approx.77% S.epidermidis ofshunt 5% 3% 5% S.aureus infections.

Coryneforms Streptococci Enterococci

7%

10%

70%

Staph. epidermidis
Staph. aureus
Enterococci & other Gram pos.

Other species of CoNS

Coryneforms
Gram negatives and others

InternalorExternal?

Internal Majority S.epidermidis orCoryneforms

External Minority Woundinfectioncomplicated byforeignbody S.aureus

Contd..
InternalShuntInfection Theorganismsstartto multiply Andtheyproduce extracellularslime Thiscan,intime, completelyblocktheshunt

Howareantibioticimpregnatedshuntsmade?
CHCl3 Normal silicone molecule matrix Matrix contracts trapping drugs inside

In chloroform the matrix expands

The antibiotics fill the gaps

Squeezed in under pressure

Contd.. HowDoTheyWork?

CSF

Duetotheconcentrationdifference betweenthecatheterandthe externalenvironment,thereisa positivediffusiongradient whichcausesthedrugstoslowly diffuseoutofthesilicone.

CSF

Theconcentrationofdrugsat thesurfaceofthecatheteris highenoughtoinhibit colonization.

CSF

Precaution
PreImplantTechnique SurgeonshouldnotpresoakBactisealinsalineor antibioticsolutionspriortoimplantationbecause thediffusionprocesswillbeactivated.

Reductionininfection
Significantreductioninshuntinfectionratewith antibioticimpregnatedshunt.(from6.5%to 1.2%). Pvalue 0.0015. ChrisXetal,deptofNS,Vic.Australia. J.OfclinicalneurosciencesJUNE2007.

Infectionrates

BioGlide
BioGlide is a covelently-bonded hydrogel that aids with ease of insertion, reduces bacterial adhesion, and absorbs water-soluable antibiotic solutions Created to address the issue of infection

BioGlide

BioGlide
Saline Radius of Motion Hydrogel Tail Covalent Bond

Polymer Substrate (Silicone)

BioGlide

BioGlide
We can say:
Hydrophilic, lubricious surface facilitates insertion Smoother surface than non BioGlide treated surface

We should be cautious saying:

Biocompatability Reduced Bacterial Adhesion Absorption of Antibiotics

Specificrequirements
Posthemorrhagichydrocephalusofthe prematurenewborn/Pressuredifferentialvalve ofballincupordiaphragmdesign,becauseof theforgivenessofhighproteinandcellular debris. Highbrainturgorpatients(achondroplasia, Crouzons,others)=Highestpressurevalve tolerated.Mayevenneedvalvesinseries. Lowbrainturgorpatients(NormalPressure Hydrocephalus)/Lowpressurevalvewitha mechanismthatpreventsorretardssiphoning.

Specificrequirements
Posthemorrhagichydrocephalus Highbrainturgor patients(achondroplasia ofthepremature
,Crouzons,others) Lowbrainturgor patients(NPH)

Pressuredifferentialvalveof ballincupordiaphragmdesign

Highpressureshunts Mayevenneedvalves inseries.

LPshuntwithASD

Costofvariousshuntsystems
No. 1 2 3. 4. 5. 6. 7. Name Codmanprogrammable Medtronicprogrammable Diamond(vygon) Bactiseal Phoenix(vygon) Ceredrain Chhabra Rupees 45,000 39,000 17,000 12,000 5,000 1,300 1,240

IndianScenario
Theinexpensive Chhabrashuntin comparisonto Codmanshunthadno statisticallysignificant diffinoutcome(J
Neurosurgery{peds4}102:358 362,2005)

Valvedesigntrials
MulticentrerandomizedtrialsofCSFshunt valvedesignhavefailedtodemonstrateany differenceamongthevalvesincasesofshunt failure.
1. DRAKEJmetalRCTofCSFvalvedesigninpediatricpts. Neurosurgery43:294305.1999 2. Pollacketal RCTofaprogrammablevalveversusa conventionalvalveforpatientswithHCP.Neurosurgery 45:13991408,1999. Exception=Antibioticimpregnatedshunt.

UnmetMedicalNeeds Shunting
SmartShunting
IntracranialPressureSensing CSFShuntFlowSensing InternalFeedbackControl

ReductionofShuntInfectionRates Selfhealingpropertiesandtheabilityto elongatewithpatientgrowth,maybe characteristicoffuturebiomaterials.

NextGenerationValve
StagedDevelopmentPlan
Phase A Phase B Phase C New Engine Open

ICP Sensor Location

IntegratedInto CHPVReservoir

Ventricular CatheterBased? Parenchymal? ExistingConfig

Ventricular CatheterBased? Parenchymal? NonMagnetic/Onoff IncPRange/VPLP FlowControl

Key Valve Specs

ExistingConfig ModifiedReservoir

NotFDAapproved productindevelopment

Apply Medical technology in order to alleviate pain, restore health and extend life.