FineTech Medical. WP10 - Functional Electrical Stimulation (FES) John Spensley. 01 st December 2005 HA Year 2 Dissemination [FTM] 1

Transcription

1 FineTech Medical WP10 - Functional Electrical Stimulation (FES) John Spensley 01 st December 2005 HA Year 2 Dissemination [FTM] 1

2 Work 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

3 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

4 Roles of the WP10 team WP10 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 WP10 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

5 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 (ISO ) quality system and CE marked by ourselves as the manufacturer. Scientific Established track record of research into FES for both surface and implanted applications. 01st December 2005 HA Year 2 Dissemination [FTM] 5

6 Salisbury Hospitals role in WP10 2 Channel surface stimulator 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. 01st December 2005 HA Year 2 Dissemination [FTM] 6

7 Salisbury Hospitals role in WP10 6 Channel surface stimulator 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. 01st December 2005 HA Year 2 Dissemination [FTM] 7

8 Salisbury Hospitals progress report Design 2 channel surface stimulator to BS EN COMPLETED Design patient trials and develop Protocols. COMPLETED Gain Research and Development & Ethics Committee approval for trials. COMPLETED Develop embedded software to BS EN COMPLETED Clinical trialling & continued development. IN PROGRESS Clinical trials 2 Channel Implant. 01st December 2005 HA Year 2 Dissemination [FTM] 8

9 Salisbury Hospitals progress report Design 6 channel surface stimulator to BS EN PRELIMINARY DESIGN Develop embedded Software to BS EN PRELIMINARY DESIGN Develop User Interface software to BS EN PRELIMINARY DESIGN Clinical trialling & continued Development PROTOCOL APPROVED Application software ready for 6 channel demonstrator. 01st December 2005 HA Year 2 Dissemination [FTM] 9

10 Salisbury Hospitals first trial 2 channel surface stimulator trials 10 patients seen 4 times at 2 week intervals. Complexity of control methods increased at each visit. Selection criteria & Outcome measures 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). 01st December 2005 HA Year 2 Dissemination [FTM] 10

11 Salisbury Hospitals trial stimulator Mark I 01st December 2005 HA Year 2 Dissemination [FTM] 11

12 Salisbury Hospitals trial stimulator 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 01st December 2005 HA Year 2 Dissemination [FTM] 12

13 Salisbury Hospitals patient video 01st December 2005 HA Year 2 Dissemination [FTM] 13

14 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

15 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

16 Improved 2-Channel Implant Design 50mm Suture area 23mm Receiver 1 Receiver 2 Anode 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

17 Epimysial Electrode 21mm 12.5mm Fabric backing 6.5mm 3mm exposure 1mm cable Design and manufacture by FineTech mm 01 st December 2005 HA Year 2 Dissemination [FTM] 17

18 Electrode Testing 01 st December 2005 HA Year 2 Dissemination [FTM] 18

19 Electrode Test Setup 01 st December 2005 HA Year 2 Dissemination [FTM] 19

20 Test result Platinum Electrodes - Impedance Calculated impedance 1400 Electrode impedance (Ohms) mm Button 4mm Button 3mm Button 2mm Button 1.5mm Button Separation distance (mm) Separation distance 01 st December 2005 HA Year 2 Dissemination [FTM] 20

21 2-Channel Implant mm 01 st December 2005 HA Year 2 Dissemination [FTM] 21

22 Mis-alignment X-axis Mis-alignment Operating Area Receiver current at 470R load (ma) MHz 22 2MHz X-axis mis-alignment (mm) Receiver 1 Receiver 2 mm Transmitter 1 (35mm dia) X-axis Transmitter 2 No Crosstalk 01 st December 2005 HA Year 2 Dissemination [FTM] 22

23 Mis-alignment Receiver current at 470R load (ma) Y-axis Mis-alignment Operating Area MHz 22 2MHz 20 1MHz xtalk 18 2MHz xtalk Y-axis mis-alignment (mm) Receiver-1 No Crosstalk Receiver 1 Receiver 2 Y-axis mm Transmitter 1 (35mm dia) Transmitter 2 01 st December 2005 HA Year 2 Dissemination [FTM] 23

24 External Controller mm 01 st December 2005 HA Year 2 Dissemination [FTM] 24

25 External Control Box mm 01 st December 2005 HA Year 2 Dissemination [FTM] 25

26 6-Channel Implant System IMPLANT MHz BASE STATION Epimysial ANODE SENSOR 433MHz Wake-Up 2.45GHz 01 st December 2005 HA Year 2 Dissemination [FTM] 26

27 Battery Charger Initial design testing with positive results Further design input required Q3 06 mm 01 st December 2005 HA Year 2 Dissemination [FTM] 27

28 Wireless 3-axis Sensor Programmable 433MHz transmitter 01 st December 2005 HA Year 2 Dissemination [FTM] 28

29 Wireless 6-Channel Implant Module 25mm Charging Coil 25mm 7mm Female Connector Hermetic enclosure Implant module Male connector/cable 01 st December 2005 HA Year 2 Dissemination [FTM] 29

30 FineTech Medical progress so far System Specification 2 & 6 channel COMPLETED External Hardware Design COMPLETED Implant Design 2 Channel COMPLETED Sensor Design (FTM in box) COMPLETED Software development. Surface v1.0 v2.0 Implant v3.0 Clinical trials 2 Channel Implant. IN PROGRESS Start OCTOBER st December 2005 HA Year 2 Dissemination [FTM] 30

31 Summary Design Completed. Clinical Applications defined. Technology requirements completed. NEXT STEPS Test Surface Stimulator and review results Implant validation plan and MHRA approval Implant Clinical Trial - start October 2006 Design work on 6-channel implant system 01 st December 2005 HA Year 2 Dissemination [FTM] 31