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“Drop foot frame”
MEDICAL NEEDS
• The pa'ent presents drop foot, which is the reduced dorsiflexion of the ankle during the swing phase of gait, poten'ally leading to trips or falls. • Causes include: neurodegenera've disorders, spinal muscular atrophy and local compression or demage to the peroneal nerve.
Device requirements: -‐ prevents dragging of the toes in the
swing phase -‐ support to the user foot -‐ it is easy to wear and remove -‐ no risks for the pa'ent
STATE OF ART
• Func'onal electrical s'mula'on (FES)
• Ankle foot orthoses (AFO)
Measurements • Most common shoe size(males) –
size 9 • Sole length; 25-‐26cm • Sole width; 8.4 – 9.4cm
PARTS
SOLE
BRACELET
STRAPS
PROTOTYPE
v Material Carbon Fiber – for support Neoprene – for user comfort
SIMULATION OF MATERIALS AND FORCES
Rigidity
Tensile Strength
Final design
• Held into the user’s shoe • The orthosis consists on a sole, which is connected to an anklet embracing the user’s leg
• One single piece
Manufacture
TEMPERATURE CYCLE
• Heat at 1-‐3ºC/min to 110ºC ± 5ºC. • Hold at 110ºC ± 5ºC for 60 minutes ± 5
minutes. • Heat at 1-‐3ºC/min to 180ºC ± 5ºC. • Hold at 180ºC ± 5ºC for 120 minutes ±
5 minutes. • Cool at 2-‐5ºC/min.
PRESSURE CYCLE
• Apply full vacuum (1 bar). • Apply 7 bar gauge
autoclave pressure. • Reduce the vacuum to a
safety value of 0.2 bar when the autoclave pressure reaches approximately 1 bar gauge.
PREVIOUS STEP
• Superimposing the swaths alterna'ng the direc'on between 0º and 90º
MECHANICAL TESTS
Literature researches to understand the mechanical problem
Crea'on of the specimens and mechanical characteriza'on
Mathema'cal simula'on to define the becer design and dimensions
Prototype crea'on to evaluate: -‐ Fa'gue stress; -‐ Prof strength -‐ Ul'mate strength
Comparison of parameters obtained with devices already on the market and daily needs of the pa'ent
Quality control
ISO STANDARDS
• ISO 22523_2006: this standard is specific for the device; • EN ISO 14971:2012: risk management; • MEDDEV 2.7.1 rev 4 CLINICAL EVALUATION: informa'on on methods used to assess the clinical performance and the clinical benefit of a medical device; • IEC 62366-‐1: This standard provides guidance on how to manage the human factors while designing a medical device (usability engineering); • EN ISO 15223-‐1:2016: This standard lists a series of symbols that may be applicable in labels of medical devices; • ISO 10993-‐1: biocompa'bility.
CHALLENGES • Limited 'me • Lack of materials • 3D printer breakdown
RECCOMENDATIONS • More hands on 'me • Post summer-‐school
Future Prospects • Mechanical tests • Sensoriza'on • Monitoring • actua'on
This project has received funding from the European Union’s Horizon 2020 research and innova<on programme under grant agreement No 731053
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