QAT Splint (Quick Action Traction Splint)

1. University of Pittsburgh Senior Design – BioE 1160/1161 QAT Splint (Quick Action Traction Splint) Azita Elyaderani A.J. Malkiewicz Stephen Smigel David Weiser April 18, 2006 Mentor: Thomas Platt, M.Ed. (Department of Emergency Medicine, University of Pittsburgh)

2. Background • Femur: The femur bone runs from the hip to the knee and is the longest and strongest bone in the body. • Femur fractures cause the quadriceps muscles to become very constricted. • As with many orthopedic injuries, loosing a large amount of blood and pain management are the most significant issues. A Devgan, et al: Critical Evaluation of Management of Fracture Shaft Femur by Brooker Willis Nail. The Internet Journal of Orthopedic Surgery. 2002. Volume 1 Number 2.

3. Background • Percent of total fracture population hospitalized by anatomy in 2000 • Femoral Shaft = 4.9 • Percent of femur fractures treated inpatient versus outpatient 2000 Inpatient outpatient 99 1 From: “Trauma Fixation,22 may 2003, frost and sullivan report”

4. Traction Splint Sager Traction Splint • Function: This device is used for stabilizing femur fractures. Hare traction splint http://www.eo.com.sg/image/Consumable/Sager-splint.jpg Quick Action Traction http://www.splints.com/pages_products/pivot_trac_splint.html

5. FDA Regulation TITLE 21--FOOD AND DRUGS CHAPTER I—FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 888-- ORTHOPEDIC DEVICES • Subpart E– Surgical Devices • Sec. 888.5890 Noninvasive traction component • (a) Identification. A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does not penetrate the skin and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic pulling force may be applied to the patient’s body. • (b) Classification. Class I (performance standards). US Food and Drug Administration:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=888.5890

6. Problem Statement • Problem: Traction splints are simply not utilized • Difficult and awkward to use • Do not fit in smaller ambulances • Usually require more than one EMS provider to put it on • Time consuming to apply

7. Initial Survey of EMT Student Total people surveyed: 29 • What is disliked about traction splints: • Extend past patient’s foot too far • Takes too long to apply • Takes more than one person to apply • Difficult to use • Bulky and awkward • Needs a better way to be braced against the pelvis

8. Design Requirements • Customer: • Trained EMS providers in pre-hospital settings • Ultimate Goals: • Minimize length traction splint extends beyond the patient’s feet • Allow single EMS provider to apply traction splint • More ergonomic mechanism for applying traction • Does not interfere with spinal immobilization devices

9. Proposed Solution • Redesign of Ischial Pad in Y configuration to sit on outlet of pelvis and conform to increase patient comfort and not impinge on male or female anatomy • Ergonomic release handle allows single EMS provider to extend splint to apply traction • Caribiner-like clip at distal end of splint allows quick attachment of ankle harness strap

10. Design Iterations of Ischial Pad Refined design to get manufacturing estimate Ischial Pad Design Redesigned for prototyping

11. Tensioning mechanism borrowed from a Quick-Grip bar clamp http://www.irwin.com/ Ischial pad, prototyped from aluminum stock Extention bar, prototyped from aluminum stock (allows collapsibility) Prototype Development

12. Conceptualized final prototype Prototype Development

13. Tensioning Mechanism Leg Straps Ankle Straps Ischial Pad Extention Bar Final Prototype

14. Final Prototype

15. Final Prototype

16. Quality System Considerations Manufacturability • Redesign Ischial Pad for rapid injection molding • Nylon Leg and Ankle straps with Velcro • Tensioning mechanism made of rapid injection molded parts and simple hardware Human factors • Ensure biocompatibility of all straps and padding • Intuitive use • Only for use by trained professionals

17. Experimental Methods • Randomly assigned groups to either the Sager or the Hare traction splint • Randomly assigned order of using the QAT splint or the competitors • Recorded time to properly apply traction • Subjects complete an anonymous survey after completing the trials

18. Results

19. Results

20. Competitive Analysis • QAT Splint • Advantages • Does not extend beyond foot • Can splint bilateral femur fractures • Tensioning mechanism • Faster • Disadvantages • Strap placement • Materials

21. Competitive Analysis • Hare Traction Splint • Cost • $225 - 275 • Advantages • Provides effective traction • Low cost • Disadvantages • Bulky and extends past foot • Can not be used for bilateral femur fractures • Requires a minimum of two EMS providers to apply http://www.spservices.co.uk/images/sp025.jpg

22. Competitive Analysis • Sager Traction Splint • Cost • $225 - 450 • Advantages • Quantifiable dynamic Traction • Does not extend beyond foot • Can splint bilateral femur fractures • Disadvantages • Expensive http://www.progressivemed.com/emsproducts/Immobilization/splints.html

23. Task Distribution

24. Future Considerations • Redesign Ischial pad to better rest against the ischial tuberosity • Replace leg straps with elastic straps • Add a leg strap positioned closer to the patient’s hip • Add a tension gauge

25. Acknowledgements • Tom Platt • Ronald Roth, MD • Pittsburgh Center for Emergency Medicine • Andy Holmes and The Swanson Institute • Mark Gartner • Generous Contribution from Dr. Linda Baker and Dr. Hal Wrigley

26. Questions???