Baby Bootie: Clubfoot Orthotic Device University of Pittsburgh Senior Design – BioE 1160/1161 Baby Bootie: Clubfoot Orthotic Device Erika J. Franzen William L. Porter Alexis C. Wickwire April 13, 2004 Mentor: Morey S. Moreland, MD Group Project Updates Pt 1 a lite version of your BioE 1160 final presentation (remind everyone of the problem, show the original schedule and goals) that now include an update of your progress including successes and problems. 15 minutes max.

Overall Goal To create an improved device design as a means of treatment of corrective therapy for clubfoot deformity

Overview Background Specific Objectives Design Results Milestones Prevalence Treatments and Methods Specific Objectives Design Considerations Development Results Milestones Future

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 infant’s left foot Faulks et al. 2005 http://www.drfoot.co.uk/pictures/clubfootrepair.jpg

3-Day Infant w/ bilateral clubfoot Prevalence 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 Faulks et al. 2005 http://www.drfoot.co.uk/pictures/clubfootrepair.jpg

Current Treatment Surgical Non-surgical Soft-tissue Bone Combination Soft-tissue manipulation Cont. passive motion Strapping Casting ii. Clearly state the customer and the customer requirements; clearly state the proposed solution to the problem (10%) All relevant information is obtained and used to support design recommendations. Briefly describe the product or service, the user problems it solves, and the audience for which it is intended. Explicitly address what you designed or redesigned Normal Clubfoot http://www.mgh.harvard.edu/ortho/ClubFoot.htm

Non-Surgical Methods 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 Plaster Casts ii. Clearly state the customer and the customer requirements; clearly state the proposed solution to the problem (10%) All relevant information is obtained and used to support design recommendations. Briefly describe the product or service, the user problems it solves, and the audience for which it is intended. Explicitly address what you designed or redesigned Corrective Braces http://www.mgh.harvard.edu/ortho/ClubFoot.htm http://www.orthoseek.com/articles/img/club2.gif

Ponseti Method Brief manual manipulation Casting @ maximum correction Percutaneous heel cord release Final cast (3 weeks) Maintain correction with brace Full time: 3 months 14-16 hours/nightwear: up to 4 y/o ~5 times (1 week each) ii. Clearly state the customer and the customer requirements; clearly state the proposed solution to the problem (10%) All relevant information is obtained and used to support design recommendations. Briefly describe the product or service, the user problems it solves, and the audience for which it is intended. Explicitly address what you designed or redesigned

Need for Improvement Costly Knee immobility Foot-to-foot constraint Complexity Production Knee immobility Foot-to-foot constraint Parental misuse Placement Removal ii. Clearly state the customer and the customer requirements; clearly state the proposed solution to the problem (10%) All relevant information is obtained and used to support design recommendations. Briefly describe the product or service, the user problems it solves, and the audience for which it is intended. Explicitly address what you designed or redesigned

Objective 3 Primary Design Requirements: Low production cost Improve comfort and effectiveness during wear/use Improve foot-brace interface Unilateral Adaptable Simplistic design Economic considerations ii. Clearly state the customer and the customer requirements; clearly state the proposed solution to the problem (10%) All relevant information is obtained and used to support design recommendations. Briefly describe the product or service, the user problems it solves, and the audience for which it is intended. Explicitly address what you designed or redesigned

Economic Considerations Significantly lower price wrt US competitive standards Materials Labor Simple design Available resources Labor and simple design can be correlated to our design not including any highly mechanical parts and no plastic molded components

Initial Design Considerations Unilateral Hazard Risk Resilience/Wearability Material cost, availability No mechanical parts No plastic molded components

Prototype Development (Lateral View) V 2.0 (Anterior View)

V 1.0 Concerns Knee constraint How to maintain position of thigh unit? Comfort Muscle, tendon atrophy and shortening How to maintain position of thigh unit? V 1.0 (Lateral View)

Prototype Version 2 V 2.0 V 2.1 V 2.2 V 2.3 (Anterior View) (Lateral View)

Proposed Solution Longer gauntlet Removed sole Removed ankle strap Material buckling Strap attachment points V 2.4 (Lateral View)

Fabrication Limitations Inaccessibility to patients Mold adult foot Non-representative casting size Reduced ankle flexibility, rotation Healthy foot (no clubfoot)

Prototype Lateral Anterior Medial Posterior

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

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 Start as Slide 16

Posture Correction External Rotation Dorsiflexion

Validation: Independent Evaluation Feedback Pediatric Orthopedic Surgeons O&P manufacturer Initial Reaction: FAVORABLE Wearability Ease of use Positioning Concern: scalability

Cost Analysis Custom to patient: US $160 Mass produced: US $80 Satisfies objective 1

Wearability Unilateral Knee mobility Open heel, toe Ankle lace-up Growth and development Verify correct wear/placement Ankle lace-up Provides intimate fit

Adaptability Need another slide on OUR adaptability…just using this one as a guideline of “look….they could do it with the DBB….we can do it with ours, blah blah blah) US $200-300 US $12 http://www.mgh.harvard.edu/ortho/ClubFoot.htm

Competitive Analysis Denis-Browne Bar Wheaton Brace Bilateral US $200-$300 Adaptable Wheaton Brace Unilateral Knee constraint US $200-$300 Not adaptable Check about registered products/trademarks (not) adaptable wrt to developing countries based on their capabilities and resources “by satisfying all three of our objectives we can perform a competitive analysis…” http://www.mgh.harvard.edu/ortho/ClubFoot.htm http://www.orthoseek.com/articles/img/club2.gif

Competitive Analysis X Low Cost Unilateral Adaptable Ease of Use DBB Wheaton Our Design Low Cost X Unilateral Adaptable Ease of Use Mobility

Project Milestones Contacted project mentor @ Children’s 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

Future Fabricate properly scaled brace Establish standardized sizes Adapt parallel design for in developing countries Further evaluation Patients Clinicians

Acknowledgements Generous gift of Drs. Hal Wrigley and Linda Baker Dr. Moreland Dr. Mendelson Bob Mawhinney Department of Bioengineering, University of Pittsburgh “…Bob Mawhinney and the rest of the Hanger Prosthetics and Orthotics, Inc. team for being so helpful and wonderful to work with!” Acknowledge Mark for his help on the Enterprize competition?

Thank You!