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BioEng 1161 Dept of Bioengineering University of Pittsburgh April 18, 2005. Stump Cone. Marissa Ammer Jonisha Pollard Alison Saulsbery Mentor: Bob Maguire DeLatorre Orthotics and Prosthetics, Inc. Amputation Procedure. www.wheelessonline.com.
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BioEng 1161 Dept of Bioengineering University of Pittsburgh April 18, 2005 Stump Cone Marissa Ammer Jonisha Pollard Alison Saulsbery Mentor: Bob Maguire DeLatorre Orthotics and Prosthetics, Inc.
Amputation Procedure www.wheelessonline.com Sugarbaker, Bickels, Malawer; “Above-knee Amputation” www. Sarcoma.org
Background • Post-amputation dressings are applied to stump to: • Reduce edema (fluid collection) • Prevent Thrombo (clotting) and embolic (occlusion of blood vessels) complications • Stabilize stump shape • Protect the stump from injury • Three types of dressings: soft, semi-rigid, rigid • Soft dressings become a hassle, rigid dressings do not allow for wound cleaning or expansion • Our device is semi-rigid
Types of Dressings Soft Rigid Semi Rigid Ace bandage Cast “Crash Helmet”
Competitive Analysis • Soft dressings, Ace Bandages • Rigid dressings, such as casts • Weight bearing devices, such as FloTech • Semi-rigid removable dressings, such as PSRRD, “Crash Helmet”
Design Criteria • The Stump Cone will use surgical spacer socks that can easily accommodate shape change throughout the day • As the residual limb becomes smaller, the device will be able to fit around it maintaining compression • The shell will be a harder plastic to protect the limb against bumps and falls
Economic Consideration • Hopefully covered by health insurance, but if not completely, still relatively inexpensive. • Market Size – $360 million in North America • 3 million patients • $1200 allowable charge for insurance (Anthem Blue Cross Blue Shield) • Product will be distributed through hospitals and medical centers
SolidWorks Modeling • First designs in the planning stage
Advantages of the New Design • Shock protection • Via Comcore – patented composite material with excellent impact strength and fatigue life
Advantages • Fluid Drainage through drainage holes
Advantages • Adjustable • “clam shell” • Velcro strapping
Advantages • Pressure Relief • Thermo plastic material • Bottom opening
Advantages • Antibacterial Protection • Charcoal padding- activated charcoal absorbs bacterial toxins and odor.
Advantages • Non-weight bearing • Less bulk • No buttock support • More comfortable for user
Advantages • Best of both worlds • Integrating features from soft and rigid dressings
Methods to Test the Stump Cone • Run an FEA in COSMOSWorks • Survey prosthetists on what they think of the device
Results of FEA Testing 50 lbs Normal Force Factor of Safety = 4.2 (Design Check)
Results from Testing • Survey Results from Prosthetists: • Comfort Level: 8 • Pressure: 8 • Ease of Use: 8.75 • Adjustability: 7.25 • Protection: 9.25 • On Scale of 1 to 10, where 10 is the best
FDA Regulations • Class I Device • Permanent Device (greater than 30 days of use) • Contact with the skin
Acknowledgements • Funding Contributions • Drs. Hal Wrigley and Linda Baker • The Bioengineering Department • Donation of Materials from DeLatorre O&P • DeLatorre O&P of Pittsburgh Personnel • Brian – the technician that made our prototype • Drew Buffat, CP - Director of Prosthetics • Bob Maguire, CP • Jason, Head Prosthetic Technician • Department of Bioengineering, University of Pittsburgh
"...devices like those are the best for treatment." " Absolutely! It would shape the limb wonderfully."