Baby Bootie: Clubfoot Orthotic Device University of Pittsburgh Senior Design –...

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Transcript of Baby Bootie: Clubfoot Orthotic Device University of Pittsburgh Senior Design –...

  • Slide 1
  • Baby Bootie: Clubfoot Orthotic Device University of Pittsburgh Senior Design BioE 1160/1161 Erika J. Franzen William L. Porter Alexis C. Wickwire April 13, 2004 Mentor: Morey S. Moreland, MD
  • Slide 2
  • Overall Goal To create an improved device design as a means of treatment of corrective therapy for clubfoot deformity
  • Slide 3
  • Overview Background Prevalence Treatments and Methods Specific Objectives Design Considerations Development Results Milestones Future
  • Slide 4
  • Background: Clubfoot Congenital, idiopathic foot deformity Affects bones, joints, muscles, and blood vessels Ankle equinus, heel varus, midfoot cavus, and forefoot adduction Foot position is pointing downwards and twisted inwards Anterior view of infants left foot http://www.drfoot.co.uk/pictures/clubfootrepair.jpg Faulks et al. 2005
  • Slide 5
  • Prevalence ~1/1,000 births in the US 100,000 cases annually 5-7 times greater in developing countries 80% of all cases Up to 50% bilateral cases Family history in 24% patients (familial) Twice as prevalent in males than females 3-Day Infant w/ bilateral clubfoot http://www.drfoot.co.uk/pictures/clubfootrepair.jpg Faulks et al. 2005
  • Slide 6
  • Current Treatment Surgical Soft-tissue Bone Combination Non-surgical Soft-tissue manipulation Cont. passive motion Strapping Casting Normal Clubfoot http://www.mgh.harvard.edu/ortho/ClubFoot.htm
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  • Non-Surgical Methods Plaster Casts Achieve proper position of foot Dorsiflexion, ER, eversion Normal quality of life can be achieved with correction Most popularly use a combo. of casts, braces US $200 - $300 / brace US $3,000 for 12 months Ponseti Method Corrective Braces http://www.orthoseek.com/articles/img/club2.gif http://www.mgh.harvard.edu/ortho/ClubFoot.htm
  • Slide 8
  • Ponseti Method 1.Brief manual manipulation 2.Casting @ maximum correction 3.Percutaneous heel cord release 4.Final cast (3 weeks) 5.Maintain correction with brace Full time: 3 months 14-16 hours/nightwear: up to 4 y/o ~5 times (1 week each)
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  • Need for Improvement Costly Complexity Production Knee immobility Foot-to-foot constraint Parental misuse Placement Removal
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  • Objective 3 Primary Design Requirements: 1.Low production cost 2.Improve comfort and effectiveness during wear/use Improve foot-brace interface Unilateral 3.Adaptable Simplistic design Economic considerations
  • Slide 11
  • Economic Considerations Significantly lower price wrt US competitive standards Materials Labor Simple design Available resources
  • Slide 12
  • Unilateral Hazard Risk Resilience/Wearability Material cost, availability No mechanical parts No plastic molded components Initial Design Considerations
  • Slide 13
  • Prototype Development V 1.0 (Lateral View) V 2.0 (Anterior View)
  • Slide 14
  • V 1.0 Concerns V 1.0 (Lateral View) Knee constraint Comfort Muscle, tendon atrophy and shortening How to maintain position of thigh unit?
  • Slide 15
  • Prototype Version 2 V 2.1V 2.2V 2.3 V 2.0 (Anterior View) (Lateral View)
  • Slide 16
  • Proposed Solution V 2.4 Longer gauntlet Removed sole Removed ankle strap Material buckling Strap attachment points (Lateral View)
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  • Fabrication Limitations Inaccessibility to patients Mold adult foot Non-representative casting size Reduced ankle flexibility, rotation Healthy foot (no clubfoot)
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  • Prototype Anterior Posterior Lateral Medial
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  • Materials: Gauntlet Outside - Calfskin (light weight) tanned black Inside - Horsehide (lightweight) pearl tanned Padding polyethylene foam closed cell Moisture barrier Nylon laces through brass eyelets Polyethylene stay Stainless steel bone
  • Slide 20
  • Materials: Strapping 1 Velcro straps backed with light polyester Dacron webbing Z69 bonded nylon thread AA eyelets Big double headed rapid rivet nickel plated brass
  • Slide 21
  • Posture Correction DorsiflexionExternal Rotation
  • Slide 22
  • Validation: Independent Evaluation Feedback Pediatric Orthopedic Surgeons O&P manufacturer Initial Reaction: FAVORABLE Wearability Ease of use Positioning Concern: scalability
  • Slide 23
  • Cost Analysis Custom to patient: US $160 Mass produced: US $80
  • Slide 24
  • Wearability Unilateral Knee mobility Open heel, toe Growth and development Verify correct wear/placement Ankle lace-up Provides intimate fit
  • Slide 25
  • Adaptability US $200-300 US $12 http://www.mgh.harvard.edu/ortho/ClubFoot.htm
  • Slide 26
  • Competitive Analysis Denis-Browne Bar Bilateral US $200-$300 Adaptable Wheaton Brace Unilateral Knee constraint US $200-$300 Not adaptable http://www.mgh.harvard.edu/ortho/ClubFoot.htmhttp://www.orthoseek.com/articles/img/club2.gif
  • Slide 27
  • Competitive Analysis DBBWheatonOur Design Low Cost X Unilateral XX Adaptable XX Ease of Use XX Mobility X
  • Slide 28
  • Project Milestones Contacted project mentor @ Childrens Hospital (Dr. Moreland) Prototype designs Contacted potential manufacturer at Hanger Prosthetics and Orthotics, Inc. (Bob Mawhinney) Fabricated 2 prototypes Evaluation/Validation Submitted business proposal to the Enterprize Business Competition Compiled Design History File
  • Slide 29
  • Future Fabricate properly scaled brace Establish standardized sizes Adapt parallel design for in developing countries Further evaluation Patients Clinicians
  • Slide 30
  • Acknowledgements Generous gift of Drs. Hal Wrigley and Linda Baker Dr. Moreland Dr. Mendelson Bob Mawhinney Department of Bioengineering, University of Pittsburgh
  • Slide 31
  • Thank You!