Natural and Medical Intelligent implants Sciences ... - Stett IMAPS 2012-12-04... · Natural and Medical Sciences Institute at the University of Tübingen, ... drug delivery systems.

Natural and MedicalSciences Institute at the University of Tübingen

Intelligent implants for diagnosis and therapy

Dr. Alfred Stett

04.12.2012IMAPS Workshop Paris

Pharma and biotechnology Biomedical technology Surface and interface technology

Natural and Medical Sciences Institute at the University of Tübingen, Reutlingen

established 1985nonprofit foundation under the civil code180 staff turnover 13.1 million euros @ 2011application-oriented researchservices targetting industry, in particular small and medium-sized enterprisesaccredited quality management system according to ISO 17025

institute affiliated to the university of Tübingenmember of the Innovation Alliance of Baden Württemberg (innBW)premium partner of the Spitzencluster microTEC Südwest

business areas

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Microsystems and Nanotechniques for Life Science applications

manipulation and analysis of molecules, cells, tissues and interfaces

micro nano bio


Microelectrode Arrays (MEA) for electrophysiology and biosensor applications

Flexible MEAbiocompatible thin-film microelectrodes (Au, Pt, TiN, Ir, C) rigid (glass, Si) and flexible (polyimide) substrates

Active MEA boardsflexible boards with integrated electronic circuits and componentsflexible barrier layers for hermetic encapsulation of microimplants

biotechnology and material engineeringmicrosystems technology and nanotechnologythinfilm and interface technology

micro nano bio


Miniaturisation of Medical Technology

Key technologies in medical technology

Computerisation Inormation and Communication technologyMiniaturisation Microsystems technology, Nanotechnology,

Optical technologiesMolecularisation Biotechnology, Tissue Engineering BMBF study, 2005

Medical technology

Progressive lines corresponding key technologies

Personalisation individualized treatment, TheranosticsNetwork connectivity digitalized networks for data exchange

and communication VDE position paper 2011Innovations in medical tech.


Miniaturised medical devicesInstruments for minimally invasive diagnosis and surgery(active) implants

cardiovascular implantsneurostimulatorsdrug delivery systems

Global market for microelectronic medical implants

innovative and dynamically growing segment of medical technology

global market for medical implants, accessories and supplies: US$ 15.4 billion, 20118.9% compound annual growth rate (CAGR)

fastest growing segments (CAGR)ear implants (18.2%). neurostimulators (10.5%) implantable drug pumps (10.5%)cardiac implants (7,4 %)

23,1 b. US$

BCC Research, 2011: http://www.bccresearch.com/report/microelectronic-medical-implants-produts-hlc016d.html


Neurostimulation

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Deep brain stimulation

Brain-Computer-Interfaces

Cochlea ImplantRetina Implant Hyppglossal nerve stimulation

Bladder stimulation

drop foot stimulator

Diaphragm stimulation

Vagus Nerve Stimulation

Stomage stimulationSpinal cord stimulation

Esophageal sphincter stimulation

Cardiac pacemaker and sensors

Cardiac pacemaker

http://www.healthcentral.com//common/images/1/19566_20826_5.jpg

metallic housing containing battery and electronic circuitryheaderleads


Telemonitoring

COMPASS – Cardiac Output Monitor with pulmonalarteriel Sensors


BioMonitorTM

subcutaneous implanted deviceautomatically detects arrhythmiasstores and transmitts electrocardiogram (ECG) recordings A B

C


Implants for restoring lost sensory functions

Cochlear implant


Headpiece

MicrophoneAudio Processor

Implant

Cochlea

AuditoryNerve

ElectrodeSystem

flexible electrode array, wave-shaped wires

Implant- housing- electronics- coil with magnet- electrode array

external audio processorwith microphone,batteries and coil

1978 first implantation at Melbourne University1984 first implantation in Europe> 220.000 implants worldwide

http://www.medel.com

Retina Implant

restoring vision by a subretinal implant

Impl

ant

retina

optic nerve

photoreceptors


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Subretinal implant system

External Supply Unit

Ceramic housingwith HF power supply

Reference electrode Polyimide multilayer

Silicone cableCMOS Chip

Flexible Substrate


Retina implant

chip for subretinal electrical stimulationchip with 1500 pixels (each 70x70 µm)chip size 3x3 mmexternal power supply,

clinical trials

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(Picture by Retina Implant AG)

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active circuitrymicroelectrodephotodiode

reading wordsobject and face recognitionmoving without assistance

Intelligent implants

Brain implants for diagnosis and therapy

Pacemaker for the brain

Prof. Thomas Schläpfer/ Uni Bonn

Deep Brain StimulationTremor, ParkinsonDepression, obsessive-compulsive disordersMedtronic, 1997 FDA approval> 80.000 patients worldwide400 implantations per year in Germany

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detects abnormal electrical activity in the brain and respond by delivering electrical stimulation to normalize brain activity before the patient experiences seizure symptoms. intracranial implant detects electrocorticogram (ECoG), depth leads for stimulationNeuropace (CA): Multi-center clinical trial Premarket Approval (PMA) application to the U.S. Food and Drug (June 2010)

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Responsive Neurostimulator for the treatment of epilepsy

21 http://www.neuropace.com/

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Flexible electrode arrays for brain recording

252 electrodessize 35 mm x 60 mmleads to external electronics


Intelligent implant projects at NMI

Pre-surgical invasive evaluation of epilepsy

epilepsy surgery is a treatment option for patients with intractable epilepsy,precise localization of the seizure focus by invasive electroencephalography (EEG) monitoring by means of subdural grid or depth electrodes,intensive care monitoring up to 2 weeks with restriction to mobility,risk for complications (infection, bleeding) due to cables,long-term recording is desired for repeated measuring of epileptic activity.

Intracranial implant for invasive evaluation of epileptic activity

safe longterm recording of brain activity without restriction tomobility of patients during pre-surgical evaluationintracranial implantat for continuous recording of EEGwireless transfer of power and data implantation max. 4 weeks


Brainboard: Flexible MEA with integrated electronis

Board with data and power management, telemetry,

thin-film encapsulation multilayer flexPCBSMD/IC

microelectrodes

8x8 mm04.12.201226 Intelligent implants

Integrated assistance system for stroke rehabilitation

restoring of grasp function of handicaped people after strokeParalysis of the forearmmoving assistance to controll grasp function

classificationwithBCI‐ algorithms

FES

EMG

motionimplant

EEG electrodes

motion ‐sensors

::::add.sensors

Intracranial implantat for stroke rehabilitation

Intracranial implantat for continuous recording of EEGwireless transfer of power and data BCI-Algorithm: extraction of intended potentials, generation of control signals for moving assistanceinterfaces to external stimulation devicesmoving assistance: cortical controlled electrical stimulation of the muscle of forearm and handpermanent intracranial implantation


Challenge

Intelligent Implants

microimplants with (a lot of) sensors, actors, electronic circuits, power supplydigital algorithms, telemetry, connectivitysmall sizes and custom designs – high complexity and functionalitycontrolled integration into tissue by bioactive surfaceschallenge: active implants with lifetime > 10 years.

MedtronicRetina Implant

CMOSChip mitElektroden

flexible Leiterbahnen

Aufbau- und Verbindungstechnik

CMOSchip with electrodes

thin-filmcable

packagingand encapsulation


Challenge: safety of active micro implants

Implants are foreign bodiesminimalinvasive, sparing surgical techniques miniaturizationcontrol of foreign body response

electronic components neither are biocompatible nor biostable

encapsulation of electronic circuits and chipslow power IC and optimized heat dissipationsafe operating state following a device failure

life time of implants is limitedreduce the need for replacement surgerybiostable designs and batteries with long life timeelimination of leads

implants may interfere with external devices and conditions

electromagnetic compatibilityMRT-compatibility

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Adhesion of proteins and cells on brain implant

gass bubbles on imperfectly encapsulated

retina chip

Longterm stability of flexible implants

Protection of electronics from ingressing water and ions by flexible encapsulation

lead

thin film electrodes

SMD/IC-devices multilayer flexPCB

Polymer layers are not suitable for longterm stable encapsulations, aren‘t they?


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Flexible and impermeable encapsulation by multi-layer systems

Water vapour barrier coating

Biocompatible polymer layer system

inorganic water vapour barrier coating

H2O-permeation through defects

Reduction of water vapour transmission by use of multilayers

Implant


Improving adhesion of polymer coating on implant

intelligent implants facilitate more specific diagnosis, more effectice therapies and daily-use aids for rehabilitation

prerequisitesadvanced combinations of materials and designsinnovative processing and fabrication methodscombination of microsystems-, nano-, biotechnology and ICTclose interdisciplinar collaboration between basic researcher, developer, health professionals and regulatory authorities.

Vision of micro medical engineering


04.12.201235

Thank you very much.

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Natural and Medical Intelligent implants Sciences ... - Stett IMAPS 2012-12-04... · Natural and Medical Sciences Institute at the University of Tübingen, ... drug delivery systems.

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