When a battlefield explosion injures a soldier's face or neck, the critical air passage between the head and lungs often becomes blocked, which can lead to brain damage and death within minutes.
To help treat such injuries, a Johns Hopkins undergraduate team has designed a low-cost, low-tech device dubbed CricSpike that may boost the success rate when combat medics need to create an artificial airway and pump air into the lungs. The goal of this procedure is to keep wounded soldiers alive until more advanced treatment can be administered at a hospital.
Although more tinkering and testing are needed, the students' early prototype design has already earned awards at two recent medical device competitions.
The student invention focuses on the emergency neck-incision tactic called a cricothyrotomy. This procedure is often depicted on TV and in movies as a relatively simple series of steps, such as stabbing a ballpoint pen into the neck, that save the life of a crucial character. But in a real-life combat setting, this tricky treatment must be done very quickly under less than ideal conditions -- and it does not always work.
In their research, the students discovered that combat medics who attempt a cricothyrotomy in the field are unsuccessful about a third of the time. Even physicians and physician assistants failed about 15 percent of the time in hospital settings. Military experts say more soldiers could be saved if the battlefield cricothyrotomy success rate could be improved.
Last fall, retired U.S. Army physician James K. Gilman, who until recently was executive director of the Johns Hopkins Military and Veterans Health Institute, presented this challenge to a group of biomedical engineering undergraduates in the Center for Bioengineering Innovation and Design Teams Program. Gilman, who rose to the rank of major general during his 35 years of Army service, served as the team's sponsor and medical adviser.
The need for better combat cricothyrotomy tools quickly became clear to the students. They learned that in recent American military conflicts in Iraq and Afghanistan, 10 to 15 percent of the preventable battlefield deaths were due to airway obstructions or respiratory failure. Many of these injuries were blamed on the growing use of explosive devices.
Preventing some of these deaths became the group's goal. "We were all excited by the emergency life-saving aspects of this project," said Antonio Spina of Streamwood, Ill., who served as team leader during his senior year.
The students designed their prototype with an eye toward simplifying and speeding up the procedure, and improving the accuracy of the insertion.
One of the main problems, the students discovered, was that the tools typically used in battle zones often do not manage to connect to the patient's trachea, commonly called the windpipe. Instead, these tools become lodged just under the patient's skin or bypass the trachea and instead strike the esophagus, which leads to the stomach, not the lungs.
To remedy this, the students devised an improved intratracheal tip that is carefully crafted to extend beyond the skin layers to the windpipe, but not far enough to reach the esophagus. To insert this tip into the neck, the students devised a two-piece handle that easily breaks away once the tip is connected to the trachea.
For demonstration purposes, the student inventors have packaged the CricSpike tip and its handle as part of a kit that also includes a scalpel to make the neck incision and an endotracheal tube to channel air to the windpipe. The kit also contains a bag valve mask that the medic can attach and squeeze to push air through the tip or tube and into the wounded soldier's lungs.
In demonstrations with a medical mannequin and animal tissue, the students have shown that their prototype components can work.
The main pieces of the students' kit will require much more refinement and testing before they could be used on human patients. But the early prototype impressed the judges at the recent medical device design competitions.
On July 14, the device was awarded second prize in the student project category at the Innovation Lab Research Exhibition, presented at the Central Institute of Healthcare Engineering of Friedrich-Alexander University in Erlangen, Germany.
In May, the CricSpike team also received a third-place prize in the 2016 Johns Hopkins Student Healthcare Design Competition, organized by the university's Center for Bioengineering Innovation and Design. This center is based within the Department of Biomedical Engineering, which is shared by the university's Whiting School of Engineering and its School of Medicine.
In addition, the students have worked with the staff of Johns Hopkins Technology Ventures in obtaining a provisional patent covering the design of their CricSpike components.
"The students did a great job," said military physician Gilman, the project's sponsor. "But the final prototype was still pretty rough. Relying on 3D printing techniques could only get them to a certain level. The next step in the development process would have to involve production of a more professional prototype."
Team member Qiuyin Ren of Westborough, Mass., a rising senior, said she and the other team members who will return to Johns Hopkins in the fall intend to build a more polished prototype during the coming school year. The student inventors hope a healthcare device maker eventually will license their design and incorporate it into an improved cricothyrotomy kit for combat areas.
In addition to Ren and team leader Spina, the students who worked on the CricSpike project were Ryan Walter of Pompano Beach, Fla.; Travis Wallace of Ellington, Conn.; Michael Good of Charlotte, N.C.; Himanshu Dashora of Powell, Ohio; Sondra Rahmeh of Austin, Texas; Jordan Kreger of Tecumseh, Mich.; and Ronak Mehta of Somerset, N.J.
Emergency physician Steven Tropello also provided assistance to the team and is included on the provisional patent. Robert H. Allen, a lecturer in the Department of Biomedical Engineering, served as the team's faculty sponsor.
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