Solution and Prototype

The solution to this clinical issue is the CricSpikeTM, a hand-held cricothyrotomy assist device developed specifically for combat medics. The device is simple and low-tech in design, consisting of only three plastic pieces. The design rationale were based on the problems identified with the current kits on the market. Our goals were to:

1. Reduce the number of steps needed, and make it easier to train 68Ws in the  procedure.

2. Improve success rate with:

   1. A blunt-tipped device that cannot puncture the posterior tracheal wall.

   2. A device with specific geometry that takes into account orientation and depth of the airway, thus preventing subcutaneous breathing tube insertion and ensuring correct tracheal placement.

3. Maintain the aspects of the procedure that are useful to combat medics, such as the multi-use scalpel.

The device itself consists of two components: a specially shaped inter-tracheal tip and a break-apart handle (which splits into two pieces).

The inter-tracheal tip is a cylindrical plastic piece which has a hollow channel in the center. The channel has an entrance port and an exit port. The entrance port on top points directly upwards, and is designed to be attached directly to a BVM to intubate the trachea directly or facilitate the insertion of a plastic breathing tube. The channel curves 90 degrees so that the exit port faces directly horizontally. This design ensures a flexible breathing tube can be passed through into the trachea. The bottom of the tip is a flat surface such that it will rest on the posterior tracheal wall. The geometry and dimensions ensure that the breathing will enter the trachea with the proper orientation.

A long break-apart handle is attached to the top of the inter-tracheal tip via simple male-female connectors. The handle length and diameter ensures that it can be firmly grasped with the entire hand. This is an ergonomic improvement over existing devices, which are all held finely with the finger-tips, usually involving two or three fingers in a claw- or pencil-like grip. The break-apart handle itself has two symmetrical parts which are also connected by male-female connectors, and indentations on the top. Once the inter-tracheal tip is inserted fully into the tracheal stoma, the handle is split down the middle and the two halves may be discarded. Thus the only purpose of the handle is to provide complete control over the process of inserting the tip into the trachea.

To elaborate on this point, the device is designed to facilitate easy tracheal insertion. The insertion is accomplished in a single unidirectional motion. This motion involves only the use of the elbow without any wrist or finger

flexion necessary. As a result, the device insertion exhibits only two degrees of freedom: the height of the device and its rotation. This is in contrast to the other cricothyrotomy devices on the market which involves many degrees of rotational and translational freedom. The procedures for the other devices involve threading the device through the cricothyroid membrane and down into the trachea. This leaves open many directions of possible failure. Our device, with its simple insertion procedure, eliminates these potential failure points and allows for easier tracheal insertion.

The device is labelled for proper directional orientation in two ways, and has a small hole at the bottom to transfer air into the trachea. The bottom of the device is flat, which helps to prevent puncture of the posterior tracheal wall. The length of the tapered portion of the CricSpikeTM is based on minimum and maximum possible depths of the human trachea.

The device also features fins on the lower portion of the inter-tracheal tip. Once the first vertical incision is made to reveal the cricothyroid membrane is made and the horizontal incision is made to open the membrane the fins on the tip are then used to further dilate the opening allowing the device to pass through into the trachea. The fins are then later utilized to keep the device held in place within the trachea to limit the possibility of the device jostling free from the neck during patient transport. A strap is fastened around the patient’s neck to further minimize movement.

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Most importantly, the CricSpikeTM does not necessarily require a breathing tube, as the airway is made open by the device itself. The handle breaks away, leaving the tapered funnel secure in the victim’s trachea, maintaining the flow of air. It is inexpensive and can be left on the battlefield.