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Research Papers

Design, Development, and Validation of an Intra-Osseous Needle Placement Guide

[+] Author and Article Information
Alexander H. Slocum, Jr.

Mem. ASME
Department of Surgery,
Brigham and Women's Hospital,
75 Francis Street,
Boston, MA 02115;
Department of Plastic and
Reconstructive Surgery,
Medical College of Wisconsin,
1155 N. Mayfair Road,
Wauwatosa, WI 53226
e-mail: ahslocum@gmail.com

Steven D. Reinitz

Thayer School of Engineering,
Dartmouth College,
14 Engineering Drive,
Hanover, NH 03755

Shailly H. Jariwala

Thayer School of Engineering,
Dartmouth College,
14 Engineering Drive,
Hanover, NH 03755
e-mail: shailly.jariwala@gmail.com

Douglas W. Van Citters

Mem. ASME
Thayer School of Engineering,
Dartmouth College,
14 Engineering Drive,
Hanover, NH 03755

Manuscript received February 3, 2017; final manuscript received June 20, 2017; published online October 19, 2017. Assoc. Editor: Rita M. Patterson.

J. Med. Devices 11(4), 041009 (Oct 19, 2017) (8 pages) Paper No: MED-17-1025; doi: 10.1115/1.4037442 History: Received February 03, 2017; Revised June 20, 2017

Intra-osseous (IO) needles are an easy and reliable alternative to intravenous (IV) access in the prehospital and emergency settings for treating patients in shock. The advantage of utilizing an IO is that secure, noncollapsible peripheral venous access can be obtained rapidly in critically ill patients. Placement of IO needles in the proximal tibia, humerus, or sternum, however, requires knowledge of human anatomy and the requisite skill to position, align, and place the device. In the developing world, this is not always available, and in the chaos of an in-hospital code, prehospital trauma, or a mass-casualty incident, even trained providers can have trouble correctly placing IV or IO needles. The Tib-Finder is an intuitive drill guide that significantly improves efficiency with which IO can be placed in the proximal tibia. Here, we present the conceptualization, design, and creation of an alpha-prototype Tib-Finder drill guide in less than 90 days; initial validation was achieved through analysis of anthropometric measurements of human skeletons, and usability studies were performed using untrained volunteers and mannequins. The Tib-Finder is intended to provide first responders and medical personnel, in the first world and the developing world, a way to accurately and repeatably locate the proximal tibia and achieve safe, rapid intravascular access in critically ill patients. Further, it eliminates the need for direct contact between patients and caregivers and improves the ease-of-use of IO devices by first responders and healthcare providers.

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Figures

Grahic Jump Location
Fig. 1

Placement of an IV (a) versus placement of an IO (b)

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Fig. 2

Sites for placement of IO catheters: (a) tibia, (b) humerus, and (c) sternum

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Fig. 3

(a) Tib-Finder initial prototype, (b) iterations of Tib-Finder during the design process, and (c) design-frozen Tib-Finder

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Fig. 4

Schematic of measurements taken on skeletal collection tibias to define the safe zone for IO placement

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Fig. 5

Tib-Finder pictographic user manual

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Fig. 6

Anthropometric measurements showing the location of the safe zone

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Fig. 7

Three-dimensional illustration using Mimics software showing the Tib-Finder in place on a model leg as well as a “bone-only” view highlighting localization of the medial surface. The trajectory of a needle is also illustrated on the isometric model.

Grahic Jump Location
Fig. 8

Human factors testing demonstrating volunteer's ability to (a) align a drill with respect to the plane and (b) centering a drill on a hole

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Fig. 9

Design-frozen Tib-Finder with labeling of important features

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