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Research Papers

Preliminary Development and Engineering Evaluation of a Novel Cricothyrotomy Device

[+] Author and Article Information
Jason P. Carey1

Department of Mechanical Engineering, University of Alberta, Edmonton, AL, T6G 2G8, Canadajason.carey@ualberta.ca

Morgan Gwin, Andrew Kan, Roger Toogood

Department of Mechanical Engineering, University of Alberta, Edmonton, AL, T6G 2G8, Canada

Barry Finegan

Department of Anesthesiology and Pain Medicine, University of Alberta, 8-120 Clinical Sciences Building, Edmonton, AB, Canada, T6G 2G3

1

1Corresponding author.

J. Med. Devices 4(3), 031009 (Sep 09, 2010) (10 pages) doi:10.1115/1.4002237 History: Received February 24, 2010; Revised July 14, 2010; Published September 09, 2010; Online September 09, 2010

Cricothyrotomy is one of the procedures used to ventilate patients with upper airway blockage. This paper examines the most regularly used and preferred cricothyrotomy devices on the market, suggests critical design specifications for improving cricothyrotomy devices, introduces a new cricothyrotomy device, and performs an engineering evaluation of the device’s critical components. Through a review of literature, manufacturer products, and patents, four principal cricothyrotomy devices currently in clinical use were identified. From the review, the Cook™ Melker device is the preferred method of clinicians but the device has acknowledged problems. A new emergency needle cricothyrotomy device (ENCD) was developed to address all design specifications identified in literature. Engineering, theoretical, and experimental assessments were performed. In situ evaluations of a prototype of the new device using porcine specimens to assess insertion, extraction, and cyclic force capabilities were performed. The device was very successful in its evaluation. Further discussion focuses on these aspects and a comparison of the new device with established devices. The proposed emergency needle cricothyrotomy device performed very well. Further work will be pursued in the future with in-vitro and in-vivo with canine models demonstrates the capabilities of the ENCD.

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Copyright © 2010 by American Society of Mechanical Engineers
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References

Figures

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Figure 10

Gauge pressure required at inflation bag for different gauge needles. Steps drops in the data show transition from turbulent to laminar flow. Tabulated results for ten gauges are provided in Table A-1 as sample data.

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Figure 11

Measured forces during insertion and removal with and without expanded cuff

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Figure 12

Components of the lung model

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Figure 13

(a) Membrane assembly front view and (b) membrane assembly side view

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Figure 1

(Top) ENCD with dimensions and (bottom) ENCD over insertion needle and component list (A: nozzle, B: sock, C: external bracer restraint, D: outer catheter, E: inner catheter, and F: Luer lock-nose indicator

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Figure 2

(a) Inner sock restraint system expansion system exploded view of components, (b) system assembled sock closed, (c) system assembled sock open, restraint system engaged, and (d) part F direction indicator

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Figure 3

Modeled nozzle configurations: (a) 20 mm radius curve nozzle with constant inner diameter, (b) expanding outlet nozzle, (c) 90 deg curved nozzle, and ((d)–(f)) Tango plus nozzle configurations

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Figure 4

Model lung design

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Figure 5

General sock geometry (dimensions in mm). Wall thickness: 0.5 mm, no. of slits=0, 2, or 4

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Figure 6

Experimental procedure of inserting ENCD using force measurement device. (a) Initial puncture, (b) securing of sock (not seen), and (c) removal of needle and force measurement system

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Figure 7

Tango plus expanding outlet nozzle jet ventilation inside model trachea. (a) No air and (b) 400 KPa jet—Nozzle deforms up but exit mainly pointed downwards with an angle of 24 deg from the vertical. Arrows point in the direction of air flow.

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Figure 8

Expanding four slit restraint sock: (a) restraint off; (b) restraint on, and (c) FEA of expanded sock

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Figure 9

Sock expansion and pull test jig: (a) empty, (b) sock with no slit, (c) sock without slit fold over failure, and (d) four slits open

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