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issue: December 2006 APPLIANCE Magazine

Medical Appliances
Quick Scan


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by Erin Biesen, Associate Editor

InfraScan worked with Bresslergroup to design a hand-held device that can detect a hematoma in the brain.

External View

With any type of head injury time is of the essence, and the quicker any form of trauma is tended the better chance of reducing risk of serious problems. A new technology from InfraScan uses infrared light to detect bleeding easily and quickly.
The unit uses a light source that shines safe, infrared light into the brain, and a detector analyzes the light that has penetrated. The process is performed at eight set points on the head, and in a brain with no hematomas there should be symmetrical light absorption. An analysis that shows absorption is not symmetrical is a sign of bleeding. The readings are sent to PDA via a Bluetooth chip.
“The technology itself was developed in the 1990s, and a clinical study showed in 305 patients that the method was 100-percent successful with superficial bleeds, and 98-percent of the deeper bleeds,” says Baruch Ben Dor, president and CEO of InfraScan (Philadelphia, Pennsylvania, U.S.). “Only one patient with a deep bleed was missed and there were no false alarms.”
In the past test, use of the product required that the patient’s head be shaved in order to get an accurate reading. InfraScan wanted to create a product that would generate an accurate reading through the hair. The company turned to Bresslergroup to help with the design process.
“They came to us literally with a black box. We started by watching them use it on patients, interviewing practitioners and basically trying to understand when it would be used and how it would be used,” explains Seth GaleWyrick, mechanical engineer with Bresslergroup (Philadelphia). “We did a lot of role playing and created mock-ups to determine size and shape as well as configuration details such as trigger and power switch position. Once the form was nailed down using both models and sketches we did the mechanical design of the actual parts.”
There was much to be learned about this complicated device prior to the development work. There were aspects of the device that InfraScan had not quantified going into the design stage, such as how much the pressure applied against the skull impacted the reading, as well as the different methods of grasping the device. Since there was a disposable probe, Bresslergroup needed to develop a way that the probe would align and attach to the device in a way that was both precise and easy to detach. The development team felt it was important, as with all handheld products, to try to accommodate left and right handed users. And they knew that the primary users would be nurses and that the unit would need to fit smaller hands.

Internal View

“Meetings in the concept development process helped us narrow the focus on the finer details, such as where the parts break up, how the icons look and where they go,” says GaleWyrick. “Development and refinement happened in 2 phases lasting approximately 2 months, and then there was a hiatus for us while InfraScan fine-tuned the electronics.”
 “Once they had the final concept we developed the final hardware, and then Bresslergroup developed the actual engineering drawings of the final mechanical parts and used them to create the final model,” Ben Dor relates.
The company also designed the disposable probe, which could be contaminated by blood from each patient. The product only has two light guides, positioned inside the legs. Bresslergroup created a third leg to keep the product stable. 
The Infrascanner has been in use in India since December 2005, and InfraScan is currently seeking U.S. FDA approval. The U.S. Navy has turned out to be a major advocate of the product, because it feels the portable unit would be quite beneficial in the battlefield. Currently there are no portable devices that can be used in the battlefield to detect hematomas. If soldiers suffer any form of head trauma this device would allow for early detection and quick treatment by drilling a hole in the skull of the patient to let the blood drain. “With a brain injury you have this first golden hour after the injury that you really have to start the treatment. If you delay it the damage will be irreversible,” Ben Dor explains.
“Recent statistics from Iraq show that 30 percent of soldiers wounded on the battlefield have brain injury, and out of them 40 percent have brain bleeding,” adds Ben Dor. “That would amount to hundreds of soldiers that could have been saved with a product such as this.”
Meanwhile, InfraScan and Bresslergroup have joined forces again to develop the next generation of the Infrascanner. It is still in the design process, but the main goal is to combine the PDA display and detector in one unit.

 

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