Healthy Aims Overview

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1 Healthy Aims Overview

2 The Healthy Aims IST Project 25 EU partners will develop a range of medical implants including: Retina implant Cochlear implant FES system for lower and upper limbs Sphincter sensor Glaucoma sensor Pressure sensor for brain cavity and aorta

3 Intracranial Pressure Sensor Glaucoma Sensor Gyro Retina Implant IMU for Human Body Motion Cochlear Implant Accelerometer Sphincter sensor Functional Electrical Stimulation

4 The medical devices will utilise these technologies Implantable energy source (conventional and fuel cell). Body Area Network to communicate from in or on the body to base station up to 3m away. Micro-electrodes on non Silicon substrates. Micro-assembly methods for true 3D systems. Biomaterials suitable for interfacing devices in the body.

5 RF Comms Biomaterials Biofuel Cells Sensor or control with MICS & antenna Application Chip Battery RF Chip Wake-Up MAC MICS RF Wake-Up Link RF Data Link 403 MHz Base station RF PCB Wake-Up RF Circuit MICS RF MAC Base Station Data Interface 3 meters max. Fouling on electrode surface blocking conductivity to nerves Neurite growth on surfaces Micro-electrodes and nanoelectronics Micro-connectors Encrustation forming on foreign bodies

6 The exploitation requires Medical devices manufacturers Medical Systems suppliers Medical Approvals bodies Surgeons and clinical teams from hospitals Medical Service providers e.g Social Services Local medical practices Purchasing teams, e.g NHS in the UK Medical Insurance groups

7 The Healthy Aims Team Research Groups in micro and nano technology Biomaterials experts RF communications experts Power sources experts Design teams Medical Device manufacturers Surgeons and clinical teams, including ethics These all came from the NEXUS Medical Devices USC and includes 6 SMEs from across the EU.

8 Wireless communications Specifically to meet the following specification MICS compatible ( MHz / 433MHz) Downlink 250 Kbit/s, Uplink 500Kbit/s Power output limited to 25µW EIRP Range metres Housekeeping software

9 System Overview

10 Micro scale electrodes Processes can provide both high density electrodes and first level interconnections. Electrode tips can be formed in 3D. Interaction with the biomaterials work package will define electrode shapes for improved electrode tissue interaction

11 Packaging & Assembly Materials Micromachining Interconnect Encapsulation and Protection Assembly and Verification

12 Cochlear implant, CTC Overall connector design microtec dummy connector attached to electrode by CTC

13 Biomolecular surface modification can be used to organise cell growth. Micro contact printing of collagen on glass substrate. PDMS Silicon Cells Scale bar 100 µm

14 Battery Cell Design R.Gardette/CEA

15 WHAT IS A BIOFUEL CELL

16 IMIT 3-axis Gyro Progress Evaluation of the ASIC for high integration level Evaluation board Detail of the MEMS structure Single axis sensor In cooperation with Melexis (B) and XFab (D)

17 Accelerometer Progress

18 Human body motion - Salford

19 Application of IMU in the project The primary application area in HA is in Advanced Functional Stimulation All current systems are controlled using basic switches or FSRs, which severely limit their usability HA will demonstrate the use of the IMU as the sensor system in the control of an advanced implantable Functional Stimulation System.

20 Cochlear Implant Present commercial product

21 Glaucoma Sensor - Wired sensor

22 Glaucoma sensor - Trials with first version Trials with first version of wired lens: Trials at Fribourg Cantonal Hospital Only sane patients tested Protocol did not allow to modify the IOP during trials Protocol: Lens traceability & patient information Anesthesia with oxybuprocain IOP measurement on both eyes with Goldman and TonoPen, Biometry of the eye. Placing the lens on the eye done by MD 1) Open eye : 3 positions (sitting / lying / standing) & Valsalva maneuver 2) Closed eye: 3 positions & Valsalva maneuver Measurements with TonoPen on second eye at every step in the protocol. Feedback from patient at the end of session

23 Our Approach The Learning Retina Implant Glasses + Camera Chip (integrated) Pocket Processor Retina Implant Visual Cortex

24 Mixed monopolar electrodes Common anode Choose up to 6 from 9 stimulation points Upper Limb Implant

25 Sphincter sensor Progress

26 Intracranial Pressure Sensor Prototype Telemetry unit Conducting lead Measuring head External reader/writer device

27 Intracranial Pressure Sensor Application: ICP 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 shunts Shunt failure Approx 40 per 100,000 Individuals have shunts in place 125,000 p.a. in USA

28 Applications: EVAR (2) Endoleak development can lead to pressurization and increased risk of rupture Continuous surveillance required Standards of clinical surveillance Contrast media enhanced CT scanning MRI Pressure measurement via percutaneous puncture L. A. Sanchez et al. in J Vasc Surg, 26,2; 1997

29 Summary at 18 months in Healthy Aims Technology development driven by medical applications. Number of technical and commercial issues. Call for new partners started in Month 17 for: Commercial partner for intra-cranial pressure sensor system FES applications Mobile communications. Copies available on