1. QAT Splint (Quick Action Traction Splint) University of Pittsburgh Senior Design – BioE 1160/1161 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 Inpatientoutpatient 991 From: “Trauma Fixation,22 may 2003, frost and sullivan report”

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

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 Ischial Pad Design Redesigned for prototyping Refined design to get manufacturing estimate

11. Prototype Development 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)

12. Prototype Development Conceptualized final prototype

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

14. 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 Time (sec) Competing SplintOrderHareSagerQAT Hare Traction SplintFirst141 65 Hare Traction SplintFirst175 81 Hare Traction SplintLast171 75 Hare Traction SplintLast100 70 Hare Traction SplintLast170 68 Sager Traction SplintFirst 11482 Sager Traction SplintFirst 22867

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 Azita Elyaderani A.J. Malkiewicz Stephen Smigel David Weiser DesignXX FabricationX Business Plan XXXX Market Research XX Document Control X Experimental Protocol XX Product Testing XX

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???