w w w .finetech-m edical.co.uk FineTech Medical WP10 - Functional Electrical Stimulation (FES) John Spensley 01 st December 2005 HA Year 2 Dissemination [FTM] 1
w w w .finetech-m edical.co.uk W ork Package Objectives Neuro-muscular stimulator for restoration of function to paralysed muscles 1. To produce a 2-channel surface stimulator – SDH � Clinical trials to identify suitable patients who can benefit from Implant � Test Sensor algorithms 2. To produce a 2-channel implant system for Clinical trials - FTM � To prove ELECTRODE � To prove SENSOR algorithms 3. Followed by a 6-channel implant demonstrator system - FTM � Demonstrator by end of 2007 � Future plan for implantable system development Applications – Wrist extension, Finger extension and Thumb extension The potential applications will improve the effect from – Stroke, Spinal Cord Injury and Cerebral Palsy 01 st December 2005 HA Year 2 Dissemination [FTM] 2
w w w .finetech-m edical.co.uk FineTech Medical ‘Specialists in active functional implants’ • Background – Commercial implant production started in 1982 after MRC technology transfer – Focussed on specialised SCI long-term implants to control bladder and bowel function – Recent new products include implanted foot and hand controllers following stroke • Quality System – Quality System qualified to BS EN 13485: 2003 to Design, Develop and Manufacture Implanted Devices – Devices are CE marked under of AIMD 90/ 385/ EEC and MDD 93/ 42/ EEC directives 01 st December 2005 HA Year 2 Dissemination [FTM] 3
w w w .finetech-m edical.co.uk Roles of the W P1 0 team W P1 0 core team • – FineTech Medical – Project Leader, Design, development and integration of the 2 Channel Implanted device. 6 Channel demonstrator development – Salisbury Hospital – Clinical trial partner. Design, development and testing of software and control methods Salford & Zarlink – Direct testing and application development – W P1 0 partners • – RF Comms/ BAN – WP1 Zarlink Electrodes – WP2 INEX – Packaging – WP3 TWI – Biomaterials – WP4 QMUL – Battery – WP5 Saft – Sensor – WP7 ETB – 01 st December 2005 HA Year 2 Dissemination [FTM] 4
w w w .finetech-m edical.co.uk Salisbury Hospitals – a unique team ‘Getting FES research into clinical practice’ Clinical • – Expertise of Functional Electrical Stimulation (FES) for restoring movement in upper motor neurone disease. Engineering • – Expertise in design and development of surface FES devises. Devices are designed to BS EN60601 as part of an ISO 13488-1996 (ISO 13485-2003) quality system and CE marked by ourselves as the manufacturer. Scientific • – Established track record of research into FES for both surface and implanted applications. www.salisburyfes.com 01 st December 2005 HA Year 2 Dissemination [FTM] 5
w w w .finetech-m edical.co.uk Salisbury Hospitals – role in W P1 0 2 Channel surface stim ulator • – Development and testing of software and control methods that will go on to be used for the implanted systems. – We will be CE marking this device for use by patients for the 6 months prior to being given an implant. Clinical trials • – Patient testing to develop the control techniques for using the motion sensor and user interface software. – Implanted 2 channel stimulator trials. www.salisburyfes.com 01 st December 2005 HA Year 2 Dissemination [FTM] 6
w w w .finetech-m edical.co.uk Salisbury Hospitals – role in W P1 0 6 Channel surface stim ulator • – Extending the control techniques used for the 2 channel implanted systems. – Development of the more complex software system required for the device. Clinical trials • – Patient testing to develop control techniques and user interface software. www.salisburyfes.com 01 st December 2005 HA Year 2 Dissemination [FTM] 7
w w w .finetech-m edical.co.uk Salisbury Hospitals – progress report Design 2 channel surface stim ulator COMPLETED to BS EN 6 0 6 0 1 . Design patient trials and develop COMPLETED Protocols. Gain Research and Developm ent & COMPLETED Ethics Com m ittee approval for trials. Develop em bedded softw are to BS EN COMPLETED 6 0 6 0 1 . Clinical trialling & continued I N PROGRESS developm ent. Clinical trials 2 Channel I m plant. www.salisburyfes.com 01 st December 2005 HA Year 2 Dissemination [FTM] 8
w w w .finetech-m edical.co.uk Salisbury Hospitals – progress report Design 6 channel surface PRELI MI NARY DESI GN stim ulator to BS EN 6 0 6 0 1 Develop em bedded PRELI MI NARY DESI GN Softw are to BS EN 6 0 6 0 1 Develop User I nterface softw are PRELI MI NARY DESI GN to BS EN 6 0 6 0 1 Clinical trialling & continued PROTOCOL APPROVED Developm ent Application softw are ready for 6 channel dem onstrator. www.salisburyfes.com 01 st December 2005 HA Year 2 Dissemination [FTM] 9
w w w .finetech-m edical.co.uk Salisbury Hospitals – first trial 2 channel surface stim ulator trials • – 10 patients seen 4 times at 2 week intervals. – Complexity of control methods increased at each visit. Selection criteria & Outcom e m easures • – Mini Mental Test– Cognitive ability. – Star Cancellation – Sensory Neglect. – Modified Ashworth Scale – assess changes in spasticity. – Disabilities of Arm, Shoulder and Hand (DASH). – Action Research Hand Test (ARAT). – Canadian Outcome Performance Measure (COPM). – Psychosocial Impact of Assistive Devices Scale (PIADS). – Use of Device Questionnaire (UDQ). www.salisburyfes.com 01 st December 2005 HA Year 2 Dissemination [FTM] 10
w w w .finetech-m edical.co.uk [FTM] 11 www.salisburyfes.com Salisbury Hospitals – trial stim ulator Mark I HA Year 2 Dissemination 01 st December 2005
w w w .finetech-m edical.co.uk Salisbury Hospitals – trial stim ulator 2 Channels. • Programmable • sequencing. Motion detection. • For use prior to • implant. We will be CE marking • this device as part of our ISO quality system. Mark II www.salisburyfes.com 01 st December 2005 HA Year 2 Dissemination [FTM] 12
w w w .finetech-m edical.co.uk www.salisburyfes.com [FTM] 13 Salisbury Hospitals – patient video HA Year 2 Dissemination 01 st December 2005
w w w .finetech-m edical.co.uk Upper Limb Implant 2-Channel: – Epimysial electrode pair 6-Channel : – Mixed mono-polar electrodes – Common anode – Choose up to 6 from 9 stimulation points 01 st December 2005 HA Year 2 Dissemination [FTM] 14
w w w .finetech-m edical.co.uk Initial 2-Channel Implant Design Anode Cathode Cable length = 15cm Electrode Diameter: 3mm • Single Transmitter Coil • Crosstalk Exists At All Time During Use 01 st December 2005 HA Year 2 Dissemination [FTM] 15
w w w .finetech-m edical.co.uk Improved 2-Channel Implant Design Suture area 50mm Anode Receiver 1 Receiver 2 23mm HA1234 Suture area Cathode • Separate Transmitter Coil For Each Channel • Flexible Body • No Crosstalk When Correctly Aligned 01 st December 2005 HA Year 2 Dissemination [FTM] 16
w w w .finetech-m edical.co.uk Epimysial Electrode 21mm 12.5mm 6.5mm 1mm cable Fabric 3mm exposure backing • Design and manufacture by FineTech mm 01 st December 2005 HA Year 2 Dissemination [FTM] 17
w w w .finetech-m edical.co.uk [FTM] 18 HA Year 2 Dissemination Electrode Testing 01 st December 2005
w w w .finetech-m edical.co.uk [FTM] 19 HA Year 2 Dissemination Electrode Test Setup 01 st December 2005
w w w .finetech-m edical.co.uk Test result Platinum Electrodes - Impedance Calculated impedance 1400 Electrode impedance (Ohms) 1200 1000 800 5mm Button 600 4mm Button 3mm Button 400 2mm Button 200 1.5mm Button 0 20 40 60 80 100 120 140 160 Separation distance (mm) • Separation distance 01 st December 2005 HA Year 2 Dissemination [FTM] 20
w w w .finetech-m edical.co.uk [FTM] 21 mm HA Year 2 Dissemination 2-Channel Implant 01 st December 2005
w w w .finetech-m edical.co.uk Mis-alignment X-axis Mis-alignment Operating Area 26 24 1MHz Transmitter 1 Receiver current at 470R load (mA) 22 (35mm dia) 2MHz 20 Receiver 1 18 16 14 X-axis 12 10 Receiver 2 8 6 4 Transmitter 2 2 mm 0 -35 -30 -25 -20 -15 -10 -5 0 5 10 15 20 25 30 35 X-axis mis-alignment (mm) • No Crosstalk 01 st December 2005 HA Year 2 Dissemination [FTM] 22
w w w .finetech-m edical.co.uk Mis-alignment Y-axis Mis-alignment Operating Area Y-axis 26 Transmitter 1 24 1MHz (35mm dia) 22 Receiver current at 470R load (mA) 2MHz 20 Receiver 1 1MHz xtalk 18 2MHz xtalk 16 14 12 10 Receiver 2 8 6 4 Transmitter 2 2 mm 0 -35 -30 -25 -20 -15 -10 -5 0 5 10 15 20 25 30 35 Y-axis mis-alignment (mm) Receiver-1 No Crosstalk 01 st December 2005 HA Year 2 Dissemination [FTM] 23
w w w .finetech-m edical.co.uk [FTM] 24 mm HA Year 2 Dissemination External Controller 01 st December 2005
w w w .finetech-m edical.co.uk [FTM] 25 mm HA Year 2 Dissemination External Control Box 01 st December 2005
w w w .finetech-m edical.co.uk 6-Channel Implant System IMPLANT 402-405MHz BASE STATION 433MHz Wake-Up 2.45GHz ANODE Epimysial SENSOR 01 st December 2005 HA Year 2 Dissemination [FTM] 26
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