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Having proven itself again and again in medical research systems, the time has come for ItoM Medical’s amplification and signal processing technology to be cast into an integrated design. The move will improve cost and performance but also open up new possibilities.
Eyes wide open, forehead beading with sweat and chest heaving violently – as anyone working in an intensive care unit will confirm, patients on mechanical ventilation aren’t always as still as you might think. Even when unconscious, a (perceived) lack of oxygen triggers a violent reaction of panic in a patient, who instinctively starts fighting for his life. It’s a very distressing experience, for both the patient and the medical staff.
‘Fighting the ventilator’ has many possible causes. A patient’s condition can change, the ventilator settings can be wrong or a tube can get clogged by secretions in the lungs. But frequently, no such obvious causes can be found. In that case, asynchrony between the patient’s own breathing rhythm and that of the ventilator may have provoked the potentially life-threatening condition.
“For years, people have tried to come up with a solution for this quite common problem, but it’s very difficult to solve. Typically, a pressure or airflow sensor in the nose is used to predict the breathing pattern, but since there’s a significant delay between the patient’s starting to inhale and detecting it in the nose, it can still go wrong,” says Jurryt Vellinga, co-founder and CEO of ItoM Medical, a Dutch electronics design house that has developed breathing monitoring solutions that have proven to be much more effective at preventing respiratory distress on the ventilator.
Now, ItoM Medical is gearing up to take the technology that underlies the breathing monitoring systems to the next level: a fully integrated application-specific standard product (ASSP) that will power a whole range of clinical monitoring systems as well as applications beyond the medical domain.
ItoM Medical’s main specialty is electrophysiology, ie performing electrical measurements on the human body. Building on technology that has had about 40 years to mature, the Dutch company supplies high-performance biometric sensing technology. “Through a combination of sophisticated amplification technology and clever signal processing, we can perform electrical activity measurements with unprecedented accuracy,” explains Vellinga.
The breathing monitoring platform aptly illustrates how good ItoM Medical’s technology really is, since measuring breathing patterns is a lot harder than most other electrophysiological measurements, such as the well-known electrocardiograms (ECG) and electroencephalograms (EEG). This is due to the fact that electrical signals from the ‘key breathing muscle’ – the diaphragm – are almost completely drowned out by the heart.
One possible work-around is to bring a sensor in close proximity to the diaphragm by inserting a probe into the esophagus, but according to Vellinga, that’s not a good solution. “While it may seem like just another tube down the patient’s throat, mechanical ventilation is increasingly performed using a mask. It would be a contradiction to move away from intubation yet introduce another invasive probe.”
Thanks to its amplification technology, ItoM Medical can pick up the diaphragm’s signal in the cacophony by using nothing more than a sensor-fitted band-aid that’s attached comfortably to the chest. After amplification and digitization, that signal is transmitted wirelessly for the ventilation equipment to process and take advantage of.
“Our customers develop their own unique products based on our generic platform and signal processing algorithms. We supply a customized design based on their specific requirements and use cases, and stay involved during subsequent phases of product development. Every detail, like choosing a cover material or a connector, can be of crucial importance,” states Vellinga. This applies not only to breathing monitoring but to other electrophysiological applications as well.
“One of our biggest strengths is our strict quality management system, which allows our customers to painlessly have their devices certified. This is particularly important now that European medical device regulations have come into force and the transition period has expired. Our goal is that devices based on our technology will be FDA and CE pre-approved. Not many companies can offer that.”
Having built an extensive track record in the business, it made sense for ItoM Medical to move to integrated electronics at some point – to design a chip that does everything the discrete platform does, and even a bit more. “Integrated designs are associated with a number of well-known advantages, such as reduced cost and energy consumption and less worry about components being discontinued. In our situation, it also offers the opportunity to add functionality. In case of breathing monitoring, for example, we can measure the electrical resistance of the electrode-skin connection, which indicates whether or not the electrode is attached properly. This simply isn’t possible using discrete electronics.”
The ASSP currently being developed packs 8 input channels for electrodes, 4 auxiliary inputs, 24-bit ADC and battery management in an 8 by 8-millimeter package that requires very little power and a minimum of external components. If all that doesn’t cut it, multiple ICs can be daisy chained to expand functionality. ItoM Medical expects engineering samples to arrive early next year, and mass production is scheduled to commence in 2021.
Technically, adopting the ASSP would transform ItoM Medical from a design house into a semiconductor supply company, but in practice, it will be a little of both. “The design services that design houses offer are rarely based on ICs they supply themselves. Conversely, semiconductor suppliers do not commonly offer electronics design services along with their ICs,” says Vellinga. “Still, it won’t make a big difference for us: we’ll still be spending most of our time working with customers to realize their products based on our technology.”
Even for just the electrophysiological applications ItoM Medical is targeting, Vellinga expects volumes to be high enough for the ASSP to be cost effective. But in the future, he intends to leverage the IC to expand the scope of his company. Wearables, for example, are increasingly equipped with biometric measurement options. Surely there would be a demand for high-quality, medically certified features that ItoM Medical’s chip would enable. Indeed, professional and amateur athletes that want to quantify their training results may soon join doctors in reaping the rewards of the company’s amplification expertise.