“ Healthy Aims” A successful FP6 project Presented at the European Funding for Life Sciences FP7 event on 20 th February 2007 by: Dr Diana Hodgins Project Co-ordinator Healthy Aims Managing Director European Technology for Business Ltd Email: diana.hodgins@etb.co.uk www.healthyaims.org SIXTH FRAMEWORK PROGRAMME Information Society Technologies
European Technology for Business Ltd � SME in the UK founded in 1997 � Specialist design company, focusing on microsystem (MST) design � Targets the medical sector because there is a need for MST in these applications � Project Co-ordinator for Healthy Aims which started in December 2003 Page 1 of 26
The development and subsequent exploitation of new products requires: � Research groups � Designers � Manufacturers � End users The benefit from ICT research will be realised when it is exploited in new products Page 2 of 26
Where ICT fits in the Supply Chain Ascertain which Agree system Learn solution with requirements technologies are manufacturers and required from end users end users ICT Smart New ICT Based Technology Systems System Integration Development Define Develop system with Work with end building manufacturers and users to exploit blocks services new system Page 3 of 26
How roadmaps can be used � Roadmap defines the systems to be developed. � Development of technologies to achieve the systems are defined with timescales. � The integration of technologies is clearly specified. � All stakeholders, including end users and services are involved in the development of the roadmap, and agree the overall objectives . Example shows the NEXUS roadmap for Medical Implants Page 4 of 26
NEXUS Device Roadmap for Medical Implants 8 Remote controlled External communication (e.g. Blue Tooth) implants + links to hospitals/treatment providers 7 Call for Wireless data/power Treatment/ coupling alarm trigg. 2 MST sensors for int. use monitoring e.g. gyro, acceler., pressure implants Wireless data/power transm. 6 FES with µ-electronics for nerve detection no ex- New MST internal sensor ternal unit Internal signal processing Power syst. for long term impl. 5 Active 3 Active implants: New MST µ-pumps/valves implants new power/data electrodes/ Implant development e.g. coupling meth. sensors pacemaker intern. 4 FES with Systems with µ-trigger external Reduced size power syst. unit Biomaterials for sensors MST sensors for external trigger 1 FES with MST power syst. for ext. trigger external Miniaturized µ-electrodes/ cables systems Biomaterials for coatings Page 5 of 26 2002 2004 2006 2008 2010
Planning a new ‘Integrated Project’ � Core group agree the outline concept, the ‘VISION’ � Agree the project co-ordinator. � Have a call for partners. � Chose a Steering Committee who then chose the consortium. � Detail the project aims, and agree with all partners. � Plan the proposal preparation as a project, and agree how it will be funded. � Agree the plan with all partners, and follow it. Page 6 of 26
The Consortium � Needs to be complementary, avoid overlap. � The complete Supply chain MUST be present, no gaps. � The partners should be world class in their field, and must fit the project. � Whilst it needs EU partners, don’t focus on bringing in particular countries, unless they fit the consortium requirements. Page 7 of 26
The Healthy Aims Consortium � 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 Partners came from the NEXUS Medical Devices USC and include 6 SMEs from across the EU. Page 8 of 26
Healthy Aims partners Page 9 of 26
‘Healthy Aims’ Goals Healthy Aims is an EU FP6 project with the goal to develop a number of intelligent medical implants and diagnostic systems, integrating a range of underpinning micro- and nano- technologies. The medical products undergoing patient trials within the Healthy Aims project provide a benchmark of today’s state- of-the-art worldwide. There are six clinical partners in the project, to help develop the system specifications, guide the development work and carry out clinical trials on prototypes. Page 10 of 26
Products being developed within Healthy Aims Intra-cranial pressure sensor passive gauge Glaucoma telemetry chip sensor antenna active gauge Retina Cochlear implant implant Bladder and bowel Electrical stimulation electrical stimulators (FES) for limb motion Sphincter sensor Activity monitor Page 11 of 26
Functional Electrical Stimulation (FES) � Sensor system used to determine when the implant should be triggered Motion Sensor � Wireless communication sends signal to trigger the implant Controller � Implanted, encapsulated electronics generate the electric pulse � Electric pulse passed into the Implant electrodes which excites the nerve Motion � Nerve causes muscle movement in Sensor the arm Electrode pair placed Electromagnetic Evoked Action close to the nerve field Potentials 1mm Epineurium Page 12 of 26
MNT developments within Healthy Aims � Examples of electrode developments within Healthy Aims that have been applied to the different implants: Glaucoma Sensor Strain gauge 3-axis gyro Retina Implant - 3D electrodes Cochlear Implant – Sphincter Sensor Modiolus electrode Page 13 of 26
Micro-packaging developments � 3D flexible packaging including ASIC thinning down to 50 µ m and flip chip bonding is one of the successes from the project so far, which is applicable to a range of products: • Glaucoma Sensor Ref sensor • Retina Implant • Cochlear Implant IC • ICP sensor Antenna active gauge Active sensor Glaucoma sensor Page 14 of 26
Communications from in the body The implant transmitters must have a wireless method for transmitting data to external receivers. The data transfer method is defined by the specific application and in some applications includes power transmission. Product Carrier freq for data Glaucoma sensor 27.3 MHz Retina implant IR Electrical Stimulation 403 MHz (MICS) Cochlear implant 5 MHz ICP sensor 13.56 MHz On the body communication use Bluetooth or Zigbee Page 15 of 26
MICS - Communicating data through the body Losses through the body are an important consideration when designing a new system. The diagram shows the energy loss for the MICS system. The antenna design is critical to the performance. Page 16 of 26
Encapsulating Biomaterials and functional interface between electrodes and nerves • Means of improving the connection between the electrode and the nerve cells to optimise charge transfer. Aligning electrically active Preventing adhesion of neurons to the electrode non electrically active surface cells. • Biocompatible encapsulating materials to stop water ingress into the implant and prevent leeching of materials from the implant into the body. Silicone rubber coated Silicone rubber with diamond-like carbon (DLC) Page 17 of 26
Implantable Rechargeable Battery � Implantable power source for the Cochlear & FES systems � First prototypes available Parameter Parameter Specification Specification No. of charges No. of charges 4000 4000 Life time Life time 10 years 5 x 10 x 22 mm Dimensions Dimensions Minimum voltage Minimum voltage 3V 5mA Average current Average current Page 18 of 26
Biofuel cell to meet future implant challenges � A biofuel cell requires no charging - hence ideal for implant applications. � Suitable for low power implants, like a pacemaker. Page 19 of 26
Some Examples of results at end Year 3 Retina implant Activity monitor Electrical stimulator for hand and wrist control Sphincter ICP Sensor and 3D packaging sensor Page 20 of 26
FP7 – The way forward � Many Healthy Aims partners are keen to pursue their work in FP7. � Some of the examples provided indicate where nanotechnology could be applied to enhance the existing state-of-the-art. � Health is a key topic in FP7 and so the potential for a project integrating nanotechnology into medical applications is high. Page 21 of 26
Examples of EU citizens we could help Elderly at risk Stroke patients Babies at risk Healthy athletes Northern Neonatal Network Page 22 of 26
Future FP7 Integrated Projects in MNT � Integrated Projects (IPs) enable complete systems to be realised effectively. � The complete Supply chain needs to be present in any system development, and SMEs are an integral and essential part of these. � Other technologies need to be integrated with MNT, e.g Biomaterials, wireless comms, in order to produce complete systems. � The goals must be agreed from the outset, and this can be achieved using Roadmaps. Page 23 of 26
Challenges still facing the clinical research community � The focus of future clinical research activities could aim for: – the performance of implantable prostheses to be closer to that of the human, – implantable in babies, – Lifetime means from 75+ years. � Medical manufacturers and clinical experts are an essential part of these new development projects to ensure that they meet the clinical need, can be implanted by surgeons and can be manufactured. Page 24 of 26
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