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01.12.2005 www.campus-micro-technologies.de 1 Healthy Aims IST-2002-1-001837 Wireless Pressure Sensor System for Intracranial Pressure Monitoring Campus Micro Technologies Matthias Wenzel [email protected]

Wireless Pressure Sensor System for Intracranial Pressure … CMT Telemetric... · 2005. 12. 9. · Intracranial Pressure Monitoring Campus Micro Technologies Matthias Wenzel

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    1Healthy Aims IST-2002-1-001837

    Wireless Pressure Sensor System for Intracranial Pressure Monitoring

    Campus Micro TechnologiesMatthias Wenzel

    [email protected]

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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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    e Thank youCampus Micro Technologies GmbH

    Universitätsallee 29D-28359 Bremen

    Germany

    T: +49 421 20 20 783F: +49 421 20 20 900

    [email protected]