Natural and Medical Intelligent implants Sciences ... - Stett IMAPS 2012-12-04... · Natural and...
Transcript of Natural and Medical Intelligent implants Sciences ... - Stett IMAPS 2012-12-04... · Natural and...
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
04.12.20122 Intelligent implants
Microsystems and Nanotechniques for Life Science applications
manipulation and analysis of molecules, cells, tissues and interfaces
micro nano bio
04.12.20123 Intelligent implants
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
04.12.20124 Intelligent implants
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.
04.12.20126 Intelligent implants
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
04.12.20127 Intelligent implants
Neurostimulation
04.12.2012 Intelligent implants8
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
http://www.healthcentral.com//common/images/1/19566_20826_5.jpg
metallic housing containing battery and electronic circuitryheaderleads
04.12.201210 Intelligent implants
Telemonitoring
COMPASS – Cardiac Output Monitor with pulmonalarteriel Sensors
04.12.201211 Intelligent implants
BioMonitorTM
subcutaneous implanted deviceautomatically detects arrhythmiasstores and transmitts electrocardiogram (ECG) recordings A B
C
04.12.201212 Intelligent implants
Cochlear implant
04.12.201214 Intelligent implants
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
04.12.201215 Intelligent implants
Subretinal implant system
External Supply Unit
Ceramic housingwith HF power supply
Reference electrode Polyimide multilayer
Silicone cableCMOS Chip
Flexible Substrate
04.12.201217 Intelligent implants
Retina implant
chip for subretinal electrical stimulationchip with 1500 pixels (each 70x70 µm)chip size 3x3 mmexternal power supply,
clinical trials
04.12.201218
(Picture by Retina Implant AG)
18
active circuitrymicroelectrodephotodiode
reading wordsobject and face recognitionmoving without assistance
Intelligent implants
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
22.11.201220 Intelligente Implantate04.12.201220 Intelligent implants
21
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)
21
Responsive Neurostimulator for the treatment of epilepsy
21 http://www.neuropace.com/
22
Flexible electrode arrays for brain recording
252 electrodessize 35 mm x 60 mmleads to external electronics
04.12.201222 Intelligent implants
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
04.12.201225 Intelligent implants
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
04.12.201228 Intelligent implants
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
04.12.201230 Intelligent implants
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
31 04.12.2012 Intelligent implants
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?
04.12.201232 Intelligent implants
33
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
04.12.201233 Intelligent implants
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
04.12.201234 Intelligent implants