1. Neckbrace Design for Patients with Amyotrophic Lateral Sclerosis (ALS) Sarah Calano Maneesha Kumar Amy McNeal Brooke Odle April 18, 2006 University of Pittsburgh Senior Design – BioE 1160-1161

2. Overview Individuals with neuromuscular degenerative diseases (e.g. amyotrophic lateral sclerosis, ALS) often suffer from neck muscle weakness While these patients require vertical head support, they remain able to rotate their head Current neck braces are designed to immobilize the head and do not allow lateral mobility

3. Project Objectives Our goal is to design a neck brace device that is able to: Provide adequate support for the weight of the head Allow lateral rotation of the head Customers: Orthotics companies (reimbursed by insurance companies) Physicians (recommendations)

4. Quality systems considerations Hazard analysis: Non collapsible material Open design Non abrasive, non allergenic materials Human factors: Girth adjustability to allow proper fitting Range of motion appropriate for daily activities Washable or replaceable pieces Durable, only padding to be replaced every 6 mo.

5. Regulatory considerations FDA Class I device (“cervical orthotic”) Other similar devices exist within this classification Specifically those with open wire frame designs (Headmaster) Patents There are no other neck braces that have been customized for ALS or designed with lateral mobility that have been patented to date

6. Constraints Overall, our device design, material composition, and testing was limited by: Cost ($500 budget) Material choices Prototyping method Personnel (Learning curve) Time Manufacturer: Hanger Orthotics Regulations (Limited clinical testing)

7. Design Iteration 1 Lateral mobility provided through pivot joints at base of neck Issues: Design not feasible since pivot joints did not provide adequate support

8. Design Iteration 2 Motion tracking data indicated constant arc, so pivot joint was designed for lateral rotation Issues: Needed larger radius (3.25 inches) than possible under the chin, not a feasible design

9. Design Iteration 3 Moved lateral motion to chin piece along track Issues: Height adjustability feature not functional

10. Design Iteration 4 Lateral translation of chin piece along track Height adjustability through varying chin piece sizes Issues: Painful pressure applied to sternum, Velcro straps pull upward at an angle (destabilizing)

11. Design Iteration 5: FINAL Front support bars moved back and positioned vertically Additional padding along sternum

12. Design Iteration 5: FINAL Posterior neck support lined with plastic Chin piece lined with open cell foam (memory foam)

13. Materials Actual materials: Wire frame: Stainless steel Track: WaterShed 11120 Resin Padding: open cell foam, closed cell foam, surgical tubing Ideal materials: Wire frame: Aluminum wire or HD-polyethylene Track: Any low coefficient of friction material that can be cast Padding: No changes

14. Engineering Tools SolidWorks 3D Design software VICON Motion tracking system Stereolithography (SLA) rapid prototyping

15. Features & Benefits Non collapsible Material Lowers chances of suffocation Open design Overheating less likely to occur No interference or pressure exertion to inhibit swallowing Adjustability Proper positioning removes interference with swallowing Alleviates soreness resulting from improper positioning Non-abrasive, breathable, hypoallergenic material Skin breakdown less likely to occur Overheating less likely

16. Competitive Analysis Competitors: 1.Philadelphia C-breeze Collar 2.Headmaster Cervical Collar 3.Executive Collar 4.Aspen Cervical Collar 1 2 3 4

17. Competitive Analysis II Our Strengths: Lateral head rotation possible through track device Discrete and open design Fully supports the weight of the head Adjustable to ensure proper positioning Durable (only soft goods need to be replaced) Easily replaceable parts Our Weaknesses: Not inherently height adjustable Depending on wearer ability, may require assistance in securing

18. Design Evaluation Methods Doctors recommend these devices to patients Prototypes were evaluated through surveys and personal interviews of ALS clinicians After trying the neck brace on, physicians and nurses ranked the device on: Functionality Comfort Appearance Overall design

19. Design Evaluation Results According to our survey results, our brace was well received by both patients and clinicians: Clinicians (n=2) Clinicians (n=3) Patient (n=1) 19/2019.7/2020/20 17/2019.7/2020/20 9.5/10 7/10 10/10 Functionality Comfort Appearance Overall design Design 4 Design 5

20. Project Summary Goal summary Design – developed a functional device according to specifications through 5 iterations Testing – patient and clinician interviews, clinician surveys completed Group responsibilities SarahManeeshaAmyBrooke ClinicalManufacturingDesignDocumentation ALS clinic meetings Problem analysis & design development Clinical & patient interviews and surveys Contact with Hanger Orthotics Materials research Market research SolidWorks modeling and design Contact with Swanson Center for prototyping Journal article Patent searches Initial business plan for design competition

21. Project Schedule Design 1: December 17 Design 2: February 17 Design 3: February 24 Design 4: March 3 Design 5: March 27

22. Acknowledgements Mentors: Dr. Sandeep Rana (AGH) Dr. Barbara Swan (AGH) Linda Talmon, LPN (ALS Association) Robert Mawhinney (Hanger Orthotics and Prosthetics) J. Andrew Holmes (Swanson Center) Human Movement & Balance Laboratory (VICON system) Beverly Welte, Pittsburgh Life Sciences Greenhouse Mark Gartner Funding: The generous gift of Dr. Hal Wrigley & Dr. Linda Baker Department of Bioengineering

23. Thank You! Questions?