1. 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.

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

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

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 infant’s left foot
Faulks et al. 2005

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

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

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

14. 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)

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

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

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

18. Prototype
Lateral
Anterior
Medial
Posterior

19. 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

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
Start as Slide 16

21. Posture Correction
External Rotation
Dorsiflexion

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

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

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

25. 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 $
US $12

26. 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…”

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

28. Project Milestones
Contacted project 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

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

30. 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?

31. Thank You!