QAT Splint (Quick Action Traction Splint)

University of PittsburghSenior Design – BioE 1160/1161

Azita ElyaderaniA.J. MalkiewiczStephen Smigel

David Weiser

April 18, 2006

Mentor: Thomas Platt, M.Ed. (Department of Emergency

Medicine, University of Pittsburgh)

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.

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”

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

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

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

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

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

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

Design Iterations of Ischial Pad

Ischial Pad Design

Redesigned forprototyping

Refined design to get manufacturing estimate

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)

Prototype Development

Conceptualized final prototype

Final Prototype

Ischial Pad

Leg StrapsAnkle Straps

TensioningMechanism

Extention Bar

Final Prototype

Final Prototype

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

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

Results

     Time (sec)  

Competing Splint Order Hare Sager QAT

Hare Traction Splint First 141   65

Hare Traction Splint First 175   81

Hare Traction Splint Last 171   75

Hare Traction Splint Last 100   70

Hare Traction Splint Last 170   68

Sager Traction Splint First   114 82

Sager Traction Splint First   228 67

ResultsApplying traction with the QAT Splint was _ _ _ _ _

than applying traction with other traction splints I have used.

0

1

2

3

4

5

6

7

Much Easier SomewhatEasier

About theSame

SomewhatHarder

Much Harder

The size of the QAT Splint is _ _ _ _ _ compared to other traction splints I have used.

0

1

2

3

4

5

6

7

8

9

Much moreconvenient

Somewhatmore

convenient

About thesame

Somewhatless

convenient

Much lessconvenient

Given a choice between the following traction splints, which would you most prefer to use?

0

1

2

3

4

5

6

7

8

Hare Traction Splint Sager Traction Splint QAT Splint

The method of applying traction by squeezing a handle was _ _ _ _ _ than other traction splints I

have used.

0

1

2

3

4

5

6

Much moreconvenient

Somewhatmore

convenient

About thesame

Somewhatless

convenient

Much lessconvenient

Competitive Analysis

• QAT Splint• Advantages

• Does not extend beyond foot• Can splint bilateral femur fractures• Tensioning mechanism• Faster

• Disadvantages• Strap placement• Materials

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

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

Task Distribution

Azita Elyaderani

A.J. Malkiewicz

Stephen Smigel

David Weiser

Design X X

Fabrication X

Business Plan X X X X

Market Research X X

Document Control X

Experimental Protocol X X

Product Testing X X

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

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

Questions???