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1Healthy Aims IST-2002-1-001837
Wireless Pressure Sensor System for Intracranial Pressure Monitoring
Campus Micro TechnologiesMatthias Wenzel
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Healthy Aims Partner
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Hydrocephalus
Hydrocephalus describes state of excessive accumulation of CSF within the fluid system of the head causing high intracranial pressure Therapy: draining CSF from the CNS by shuntsNPH market: 375,000 cases each year in the U.S., $500 Mio market sizeApprox 40 per 100,000 Individuals have shunts in placeShunt failure
40% shunts fail in 1st year, 50% by 2nd yearShunts are revised about two times in the first ten years of use per patient!
There is currently no practical way to measure shunt performance in vivo!
www.motiv-medtech.comCSF – Cerebro Spinal FluidCNS – Central Nervous SystemNPH – Normal Pressure Hydrocephalus
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Neuromonitoring
ICP monitoring in the management of severe head injuryToday‘s techniques use strain gauge tip transducers and intraventricular cathetersMain pitfalls of today’s techniques
http://connection.lww.com
High risk of infectionCatheter occlusionNeeds reposting of transducer level with change in head position
Intraventricularcatheter
Increasing drift over timeHigh risk of infectionReduction of patient mobility
Tip transducer
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Neurosurgical Applications
1. ICP monitoring in the clinical management of severe head injury and other conditions causing high ICP
Alternative approach to conventional tip transducers2. Continuous monitoring of ICP in hydrocephalus patients
Monitor shunt performance in-vivoTherapy optimization
3. Closed-loop hydrocephalus shuntsFeedback-controllingEvent-driven therapy
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Requirements
Miniaturized and flexible for minimal invasive deliveryWireless communicationNo battery or internal power sourceHighly biocompatibleWave form analysis Minimal drift and temperature stable Easy measurement at home
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System Overview
Inter
face
Modulation
Voltageregulator
AC
DC
Power
RF-tr
ansm
itter
Demodulator
Interface
Interface
Signal processing
Pressuresensor
ReferenceBase station
Inter
face
Wireless power and datatransmission
Pressure sensing tipInternal telemetry unitExternal telemetry unit
Skin Pressure
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System Overview (Cont.)
Inductive coupling
RF communication
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Prototypes
Flexible substrate
Encapsulation into polymer
Electronics FC/SMD on flex
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Device Characteristics
Telemetric powering and data read-outIntraventricular or parenchymal measurement‘Drift-free’ capacitive pressure sensorTemperature stable readingsDynamic measurement possibleEasy to insert and position; flexible
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Device Benefits
Scalp barrier reduces risk of infectionMinimal drift of sensorProlonged monitoring possibleNo replacement required
Independent from shunt therapyHome monitoring Therapy control and optimization
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Development Roadmap
2007200620052004
P8P7P6P5P4P3P2P1
Clinical trials and regulatory approval process
Frenchay Hospital, UK
2nd prototypeSystem optimization and
Design validation
Functional demonstratorComplete assembly:
SMT & FC on flex circuit
EU Market launch
Spin-off applications
Bench testingSystem design verification, in bench tests and animal model
1st prototypeSMT & FC on flex circuit;Polymer encapsulation &
Biocompatible barrier coating
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Spin-Off Applications
Monitoring endoluminal stent-grafts in abdominal aortic aneurysm repairHome monitoring of patients suffering from congestive heart failureWireless monitoring of urinary bladder pressure
…
Feed-back systems for gentle control and therapy-optimization
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Conclusion
Implantable telemetric sensor systems will be of significant value for cost-effective continuous monitoring of therapeutic procedures even under everyday life conditions.Close collaboration with clinical end-users guarantees development closely along the market needs and medical requirements.High integration of technology partners during development enables the introduction of new add reliable products.First prototypes have raised high expectations and are currentlybeing validated in bench tests.Opportunity for new commercial partner
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Universitätsallee 29D-28359 Bremen
Germany
T: +49 421 20 20 783F: +49 421 20 20 900