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VEXTEC Reliability Analysis of Above-the-Knee Leg Prosthesis. Group 11 Aashish Bapat, April Boldt, Jason Deaner, Grainger Greene, Dani Shuck. Company Overview. VEXTEC’s reliability analysis capabilities : Unique approach with usage of ‘physics of failure’ and ‘material science libraries’

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vextec reliability analysis of above the knee leg prosthesis

VEXTECReliability Analysis of Above-the-Knee Leg Prosthesis

Group 11

Aashish Bapat, April Boldt, Jason Deaner, Grainger Greene, Dani Shuck

company overview
Company Overview
  • VEXTEC’s reliability analysis capabilities:
    • Unique approach with usage of ‘physics of failure’ and ‘material science libraries’
    • Funded by a Federal government grant
    • Competitors tools are limited as they only use statistical analysis
  • Current Customers: Aerospace & Automotive markets
  • Goal:Break into the Medical Device Sector
reliability analysis technology overview
Reliability Analysis Technology Overview
  • Desktop Computational Reliability Model (DCRM)
    • Predicts fatigue failure
    • Simulates real material degradation models
  • How it works?
    • Grain structure of materials given conditions
    • Monte Carlo Probabilistic methods
    • Modeling of this early crack behavior
    • 3D Component Analysis
project goals
Project Goals
  • Predict reliability of above-the-knee prosthetic leg (Finite element analysis)
    • Material
    • Geometrical
    • Loading
    • Available data on failure
  • Modify the design of Reliability analysis software for the prosthetic leg
project goals contd
Project Goals (contd.)
  • Market Analysis
    • Potential Medical device manufactures
      • Testing cost and time reduction analysis
      • Meetings with the medical device industry to identify specific market needs
      • Aid for FDA approval
    • FDA
      • Potential tool for the FDA to run preliminary design reliability analysis
division of work
Division of Work
  • Dani: Prosthesis model, Team Leader
  • Aashish: Biomechanics
  • Jason: MSC/PATRAN modeling, Finite Element Analysis
  • Grainger: Medical device market research, manufacturing and professional contacts
  • April: Manufacturing and professional contacts
prosthetic leg analysis
Prosthetic Leg analysis
  • Journal of Rehabilitation Research & Development
    • Prosthetic Loading during kneeling
    • Blatchford Manual Lock system for K1 – K2 activities
    • 162 tests in prosthetic knee undertaken
    • Critical Shear Forces and stress measure with sensors
modeling the knee unit
Modeling the knee Unit
  • Fatigue failure often observed at the Knee Unit
  • Knee unit isolated and modeled
  • Reliability analysis on three pins shown in the socket
  • Once set up, similar analysis can be performed on the whole prosthesis to determine reliability

PSP Endo Stabilised Knee with Manual Knee Lock

knee socket model
Knee socket model

3 D model built in Pro/Engineer

PSP Endo Stabilised Knee with Manual Knee Lock

assessing the reliability of the knee unit
Assessing the reliability of the Knee Unit
  • A 2-dimensional projection of the simplified ankle joint will be analyzed in MSC/Patran with MSC/Nastran or ANSYS.
  • The results will be used in VPS-MICRO to analyze the microstructure.
  • The goal is to see what VEXTEC’s software can add to the medical industry’s current analysis techniques.
medical trade shows
Medical Trade Shows
  • Cannon Communications LLC: leader of trade show publications for medical manufacturing
    • MEDTEC Germany (Messe Stuttgart, Germany, Feb 27-March 1, 2007)
    • MD&M East (New York, NY, June 12-14, 2007)
    • MEDTEC China (Shanghai, China August 28-30, 2007)
    • MEDTEC Ireland (Galway, Ireland, September 19-20, 2007)
    • BIOMEDevice (MD&M Event, San Jose, CA, October 3-4, 2007)
    • MD&M Minneapolis (Minneapolis, MN, October 17-18, 2007)
    • MD&M West (Anaheim, CA, January 29-31, 2008)
  • Medical Device and Manufacturing Trade Shows:
    • Sponsored by Medical Device and Diagnositc Industry
medical trade shows1
Medical Trade Shows
  • Medical Design & Manufacturing West
    • January 28-31, 2008
    • Anaheim Convention Center, CA
    • Large-scale tradeshow, 1500 exhibiting companies in the $104 Billion medical device market
    • Suppliers in cardiovascular, orthopedics, prostheses, etc.
  • Medical Design & Manufacturing East
    • June 11-14, 2007
    • Jacob K. Javits Convention Center, New York City
    • Mid-size tradeshow
  • Pharma Med Device
    • April 24-26, 2007
    • Jacob K. Javits Convention Center, New York City
    • Over4,000 pharmaceutical and medical device manufacturers
  • Will look for more advice from Dr. Watson and other contacts
interview with dr fitzsimmons
Interview with Dr. Fitzsimmons
  • Easier to get devices approved in Europe
    • ISO standards less than FDA
    • Perform physical tests with predetermined forces
  • Warranties are mostly guesswork
    • Feet – 36 months
    • Knee – 24 to 36 months
    • Medicare recommends 5 year life for prosthesis
    • Ultimately depends on activity level (0-4)
    • 4 level cannot expect for device to last more than a year
  • Most failures from feet
    • Below-the-knee prostheses more common than above-the-knee, thus more feet likely to fail than knee’s
interview with dr fitzsimmons1
Interview with Dr. Fitzsimmons
  • List of manufacturers
    • Otto Bock
    • Ossur
    • Endolite
    • Ohio Willowood
    • Medi
    • Bulldog Tools
    • Jim Smith Sales
    • Euro International
    • Fillauer
  • Otto Bock has 4-5 large facilities within U.S.
  • Provided contact with Otto Bock
phone call to otto bock
Phone Call to Otto Bock
  • Spoke with Scott Weber, Marketing Manager for Feet Units at Otto Bock Minneapolis office
  • Most prostheses exempt from FDA approval, use ISO standards
    • Microprocessor knee unit is not FDA exempt
  • Physical testing is expensive and time consuming, lots of money wasted on testing incorrect prototypes
  • Exo-skeletal knee prostheses are vanishing from market
  • Feet units are more customized than Knee units, more failures in them also
phone call to otto bock contd
Phone Call to Otto Bock (contd.)
  • They do use Finite Element Analysis to some extent in their reliability analysis
    • Do not use statistical modeling, never heard of Relex or Reliasoft
    • Otto Bock goes above and beyond ISO standards in their testing
    • ISO would be a good resource for specific force loads used on prosthesis units.
  • Gave contact at Salt Lake City office
    • Sarah McCarviell, Head Engineer(?)
    • All physical testing and design engineering done at Salt Lake City office
future work
Future Work:
  • Use VEXTEC’s VPS-MICRO software to perform analysis on knee joint for kneeling forces
  • Perform same analysis on same device for walking forces
  • Speak with design engineers at different prostheses manufacturers about applicability of VEXTEC’s technology
  • Speak with FDA Compliance Consultants about possible FDA usage/acceptance