FineTech Medical WP10 - Functional Electrical Stimulation (FES) John - - PowerPoint PPT Presentation

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FineTech Medical WP10 - Functional Electrical Stimulation (FES) John - - PowerPoint PPT Presentation

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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

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FineTech Medical

WP10 - Functional Electrical Stimulation (FES) John Spensley

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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

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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

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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

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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

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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

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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

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Salisbury Hospitals – progress report

Clinical trials 2 Channel I m plant. I N PROGRESS Clinical trialling & continued developm ent. COMPLETED Develop em bedded softw are to BS EN 6 0 6 0 1 . COMPLETED Gain Research and Developm ent & Ethics Com m ittee approval for trials. COMPLETED Design patient trials and develop Protocols. COMPLETED Design 2 channel surface stim ulator to BS EN 6 0 6 0 1 .

www.salisburyfes.com

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Salisbury Hospitals – progress report

Application softw are ready for 6 channel dem onstrator. PROTOCOL APPROVED Clinical trialling & continued Developm ent PRELI MI NARY DESI GN Develop User I nterface softw are to BS EN 6 0 6 0 1 PRELI MI NARY DESI GN Develop em bedded Softw are to BS EN 6 0 6 0 1 PRELI MI NARY DESI GN Design 6 channel surface stim ulator to BS EN 6 0 6 0 1

www.salisburyfes.com

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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

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Salisbury Hospitals – trial stim ulator

Mark I

www.salisburyfes.com

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  • 2 Channels.
  • Programmable

sequencing.

  • Motion detection.
  • For use prior to

implant.

  • We will be CE marking

this device as part of

  • ur ISO quality

system.

Salisbury Hospitals – trial stim ulator

www.salisburyfes.com

Mark II

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Salisbury Hospitals – patient video

www.salisburyfes.com

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Upper Limb Implant

2-Channel:

– Epimysial electrode pair

6-Channel:

– Mixed mono-polar electrodes – Common anode – Choose up to 6 from 9 stimulation points

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Initial 2-Channel Implant Design

Cable length = 15cm Electrode Diameter: 3mm Cathode Anode

  • Single Transmitter Coil
  • Crosstalk Exists At All Time During Use
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Improved 2-Channel Implant Design

  • Separate Transmitter Coil For Each Channel
  • Flexible Body
  • No Crosstalk When Correctly Aligned

Suture area Cathode 23mm Receiver 1 Receiver 2 Anode 50mm

HA1234

Suture area

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Epimysial Electrode

mm

6.5mm 3mm exposure 12.5mm 21mm 1mm cable Fabric

backing

  • Design and manufacture by FineTech
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Electrode Testing

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Electrode Test Setup

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Test result

Platinum Electrodes - Impedance

200 400 600 800 1000 1200 1400 20 40 60 80 100 120 140 160 Separation distance (mm) Electrode impedance (Ohms) 5mm Button 4mm Button 3mm Button 2mm Button 1.5mm Button Calculated impedance

  • Separation distance
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2-Channel Implant

mm

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Mis-alignment

mm

X-axis Mis-alignment

2 4 6 8 10 12 14 16 18 20 22 24 26

  • 35
  • 30
  • 25
  • 20
  • 15
  • 10
  • 5

5 10 15 20 25 30 35

X-axis mis-alignment (mm) Receiver current at 470R load (mA)

1MHz 2MHz

Operating Area

X-axis

Receiver 1 Receiver 2

Transmitter 1 (35mm dia) Transmitter 2

  • No Crosstalk
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Mis-alignment

mm

Receiver 1 Receiver 2

Transmitter 1 (35mm dia) Transmitter 2 Y-axis

Y-axis Mis-alignment

2 4 6 8 10 12 14 16 18 20 22 24 26

  • 35
  • 30
  • 25
  • 20
  • 15
  • 10
  • 5

5 10 15 20 25 30 35

Y-axis mis-alignment (mm) Receiver current at 470R load (mA)

1MHz 2MHz 1MHz xtalk 2MHz xtalk

Operating Area Receiver-1 No Crosstalk

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External Controller

mm

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External Control Box

mm

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6-Channel Implant System

433MHz

IMPLANT

402-405MHz Wake-Up 2.45GHz

SENSOR

BASE STATION

ANODE Epimysial

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Battery Charger

mm

  • Initial design testing with positive results
  • Further design input required – Q3 ‘06
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Wireless 3-axis Sensor

  • Programmable 433MHz transmitter
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Wireless 6-Channel Implant Module

25mm 7mm

Female Connector Hermetic enclosure Male connector/cable Implant module Charging Coil

25mm

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FineTech Medical – progress so far

Start OCTOBER 2006 Clinical trials 2 Channel Implant. IN PROGRESS Software development. Surface v1.0 v2.0 Implant v3.0 COMPLETED Sensor Design (FTM in box) COMPLETED Implant Design – 2 Channel COMPLETED External Hardware Design COMPLETED System Specification – 2 & 6 channel

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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