1. Three-Segment Thoraco Lumbar Sacral Orthotic Brace Dave Hower Anjani Ravindra Jessica Schaberl Kimberly Zawrotny Project Mentor: Bob Mawhinney Hanger Orthopedic Group

2. Overview Thoraco Lumbar Sacral Orthotic Braces are used to stabilize the spine following: Spinal injuries such as compression or burst fractures: 11,000 new incidences per year in United States Surgical procedures such as spinal fusions, decompressions, or treatment for ankylosing spondylitis: ~2 million per year in the United States Traditional bi-valve TLSO braces are difficult to put on correctly, leading to improper brace placement procedures which can cause pain or ill-fit.

3. Project Objectives Redesign the TLSO brace so as to improve ease and speed of correct placement without significantly increasing the cost of the brace. Convince potential customers, such as physicians who prescribe TLSO braces for their patients, that the Three-Segment TLSO brace is an improvement over traditional bi-valve designs. Prove that Three-Segment brace is easier to put on by demonstrating faster placement procedure and reduced rolling requirements

4. Customer Requirements The brace should… Immobilize the spine Provide the same level of spinal support as current bi-valve TLSO brace designs Be easy to put on while prostrate, with minimal rolling required for correct placement Fasten securely Be designed to promote patient comfort Be the same size and weight as a bi-valve brace of same prescription Cost the same as prescribed bi-valve brace, in the range of $250.00 (excluding service charges).

5. Competitive Analysis Front Closing Brace with Hip Extension Aspen TLSO Bracing System Cybertech Medical TLSO Brace http://www.aspenmp.com/products/tlso/instructions.html http://www.cybertechmedical.com/TLSO.html http://www.bostonbrace.com/cf_boston_tlso.html

6. Design Alternatives TLSO Brace Placement Assist Device Rejected because did not allow for proper support of spine during placement Consulted with MD in rehabilitation services Shape Memory Material Rejected because of costs and insurmountable technology barriers Consulted with materials science professor Redesign Current TLSO Brace Chosen because most feasible economically and in regards to time constraints Working from established design Consulted with Orthotics Specialist

7. Three-Segment TLSO Description Custom-molded brace composed of three segments: front, left side, right side Hinges join front to side segments Side segments meet in back Connected by three straps Covers torso from pelvis to sternum in front, and hips to shoulder blades in back

8. Comparison to Competition Strengths Much less complex design Can be placed without assistance if needed Ease of manufacture No part of brace needs to be slid under patient Weaknesses Still requires rolling to place Difficult to tighten straps Current model does not include Hip Extension

9. Features and Benefits of the Redesign Split Back Segment Brace does not need to be forced underneath patient Contributes to easy placement procedure Three Connections Faster to fasten than bi-valve design with 6 connections Hinged Design Easier to manipulate brace during placement

10. Features and Benefits of Redesign Non-Velcro Straps Easier to manipulate brace during placement Will not snag or damage clothing or furniture Ease of Production Faster molding process Offsets costs of hinges, so Three- Segment brace does not cost more than bi-valve design

11. Engineering Technology: Producing Prototype Mold and Prototype Development Process Apply multiple layers of wet plaster bandages around patient Allow to dry and then remove, maintaining shape of body Fill cast with molding plaster to obtain positive mold Vacuum fold plastic on the outside Add AliPlast foam on inner side

12. Quality Systems Considerations Risk Analysis Connection, Hinge, or Material Failure Material selection and frequent inspection Improper brace placement Written and verbal instructions Skin Irritations Warning labels

13. Regulatory Considerations Searched FDA Device Classification Panels to determine device classification In accordance with 21 CFR 890.3490, the Three- Segment TLSO brace is a Class 1 Device Searched FDA 510(k) Database for Predicate Devices: Orthomedic Lumbar Flexion Brace Vertebrace Spinal Supports Followed 21 CFR 820.30 standards for medical device quality management systems

14. Project Management: Initial Schedule Presentation Second Prototype First Prototype Project Selection

15. First Prototype Second Prototype Specialist Test Presentation Project Management: Actual Schedule

16. Experimental Design and Results Orthotics Specialist Test Time comparison for Orthotics Specialist to place bi-valve brace and three-segment brace on patient Brace TypeTrialTime (sec) Bi-Valve 1 83 2105 380 Three-Segment 140 245 350

17. Experimental Design and Results Self Placement Test Time comparison for self-placement of bi- valve brace and three- segment brace Quantification of rolling required for self- placement of bi-valve brace and three- segment brace Brace TypeTrialTime (sec)Number Rolls Bi-Valve 11303.5 21112.5 31092.5 Three-Segment 11031.5 2991.5 3951.5

18. Conclusions Three-segment brace offers viable alternative to current brace designs Provides same level of support with easier placement than other TLSO designs Does not significantly increase cost Approved by orthotic and rehabilitation specialists Would prescribe for patients

19. Acknowledgements Thanks to… The generous gift of Drs. Hal Wrigley and Linda Baker Department of Bioengineering Bob Mawhinney and Hanger Orthopedic Group Staff Drs. Boninger and Fulay Andy Holmes