MPMN_Medical Product Manufacturing News

Medical Product Manufacturing News, November/December 2015

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q m e d . c o m / m p m n M e d i c a l P r o d u c t M a n u f a c t u r i n g n e w s n o v e M b e r / d e c e M b e r 2 0 1 5 2 3 "there is another component that was very important," nottingham adds. "when they teach you how to apply electrodes for an eKg, there is particular spacing you have to follow based on the anatomy." because there is wide variability in size and shapes between people, the designers of the cardioinsight device had to accommodate for that in the vest to optimize the placement of all the sensors on the body. tilk says that early prototypes revealed much operational inefficiency. "for instance, the typical industry hydrogel was too sticky and caused patient discomfort. we found a 'miracle' adhesive that allowed the vest to adhere to the patient quickly and effectively while being sweat resistant." the group redesigned vest panels so that all 252 sensors remained connected to the skin as the patient wore the vest. "the original base material of the vest wasn't flexible enough to fit around patient," tilk says. "the 'aha!' moment was creating an s-curve pattern around each sensor that would allow it to wrap around a patient's body and specific curvature, as well as allowing a little bit of stretch for fit." it proved challenging to design the vest so that it would maintain proper sensor connectivity while also fitting a wide range of body types. "each panel of the vest has 63 sensors that all ran to one common connector or plug," tilk says. "this connector had to be small for comfort and wearability, but robust enough to plug into the mapping system. lead engineer and program lead Jeff taggart invented new break walls to prevent arcing between the walls of the connectors, which enabled them to be small and light." the sensors are printed silver/ silver-chloride sensors with a printed trace (wire) that connects them to the ecvue amplifier. these sensors have a hydro gel on them that ensures a good electrical connection to the skin. "our innovation is around how these were oriented, as well as the 's' and 'u' shaped connective pathways that allowed us to use Pe film to match a patient's topology," says nottingham. "we also sourced another gel chemistry as an additional adhesive to surround the sensors. we saw a need for an adhesive to keep the sensors in position that was less aggressive then the current hydro gel they were using. this allowed us to use a hydrogel for a bit of its adhesive quality and more for its conductivity." additionally, because the vest must be worn by the patient for up to eight hours, comfort, weight, and durability were also important. "the fabric had to be comfortable and breathable," tilk says. "the construction had to be durable enough for the patient to be transferred throughout the hospital, and the vest had to survive the use of an external defibrillator, while being invisible on the fluoroscope." another complication was that the company was given an aggressive price target and had to optimize the design of the device so that it could ultimately be reimbursable. the design firm ultimately came up with a disposable product, achieving much of the weight reduction thanks to printed electronics. the design enables it to be mobile, capable of being used for mapping at the patient's bedside or in the electrophysiology lab. Making the product mobile and disposable posed unique design hurdles. "when we were designing it, we were working directly with a flex circuit manufacturer getting the drawings ready," says Jason ertel, engineering program director at nottingham spirk. "the electrodes have hexagonal shapes with limits on spacing between the electrodes. we wanted to make sure the manufacturer could do it up front instead of designing the device first," ertel says. "Just like any design transfer process, you start early with your manufacturing folks to understand what you can accomplish as opposed to doing all of your engineering and throwing it over a wall, which is unfortunately what a lot of companies do." in the end, the design of the product succeeded in helping multiple parties in the healthcare landscape. it won a gold edison award. "the patient wins because it is not invasive; it is not probing into the body. the doctor gets a higher quality result for doing this diagnosis as opposed to electrically probing the heart from the inside. and the hospital gets a reimbursement, and it doesn't take them as long to perform as other diagnostic methods," nottingham says. 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