Irish medical device helps patients to keep a cool head
16 January 2014
Roughly ten thousand people suffer a stroke in Ireland each year, with this leading to 1,928 deaths in 2012 alone, according to the Central Statistics Office figures. Understandably, research teams are keen to develop new treatment procedures aimed at reducing these figures, with mild therapeutic hypothermia considered one potential method.
Induced hypothermia has long been recognised as having neuroprotective benefits and is regularly used in the treatment of ischaemic stroke, cardiac arrest and traumatic brain injury. Current research suggests that the main reason for its success is promoting anti-inflammatory responses that lower cerebral metabolic rate, which in turn reduces cell death at the site of injury. It is possible that the ability to administer such a treatment, prior to hospital admission, could offer enormous benefits.
Following Formula 1 driver Michael Schumacher’s recent skiing accident, brain trauma has been making headlines recently. An Irish company has developed a medical device that may of significant benefit in cases of brain injury. Eurolec Instrumentation Ltd’s ‘Cool Brain’ was designed to cool the brain at the earliest possible opportunity in the event of a stroke, heart attack or brain trauma to effect the best possible prognosis.
FROM CALIBRATION TO MEDICAL DEVICES
Tom Mears is managing director and owner of Eurolec Instrumentation Ltd. An accidental engineer, he graduated from Trinity College Dublin with a degree in English, History and Geography in 1967. Subsequently, he accepted a job in England with Rolls Royce Aeroengines during the ‘milk round’ – when recruiters visited Irish campuses to hire the best graduates.
“In England, I discovered that I’d an aptitude for engineering that I’d never realised before,” Mears said. “Ever since then, I’ve worked in the field of technology and engineering.”
Mears returned to Ireland in 1971 and worked in engineering companies. Then, in 1978, with the help of IDA Ireland, he set up Eirelec Ltd with a college friend, who was a graduate of physics and electronic engineering. Based in Dundalk, the company designed, manufactured and exported manometers, thermometers, pH and relative humidity instruments, some 90 per cent of which were exported.
The company merged with the AET Group, but when the new UK-based parent company later closed Eirelec Ltd down, Mears set up Eurolec Instrumentation Ltd in 1998 from his front room. The company now designs and manufactures temperature and pressure electronic instrumentation for laboratory/pharmachem, food, environmental and industrial/process engineering sectors. These include infrared thermometers, temperature calibration sources, manometers and multi-meter temperature/pressure probes. It also imports instruments from other well-known companies such as Testo, Ono Sokki, Grant Instruments and T&D that complement its own, e.g. data loggers, tachometers and FFT analysers.
“We’ve always worked hard to innovate and some of the products we’ve developed include infrared, non-contact thermometers, which are especially good for the food industry and HACCP certification because, obviously, they don’t touch any item or surface. We’ve also developed a temperature calibration system that permits in-house checking of accuracy can be done in house, so that companies don’t have to send their temperature instruments to an outside calibration house with all of them inconvenience involved in doing so.”
It was this spirit of enterprise and innovation, along with Mears’ ability to adapt to current markets, that saw the company take the first steps into the medical-device market. “I saw an article in the New Scientist magazine about work being done in Edinburgh into the benefits of induced hypothermia,” said Mears. “They were experimenting with air cooling with what looked like old-fashioned hairdryers. Other projects used air alone to cool the body and I though that this was something that we could investigate. At the moment, methods are generally invasive and can involve whole-body cooling, which can cause problems for some body organs. Existing methods and technology generally require mains power and a hospital environment with medically trained staff. We figured that using an insulated helmet would avoid other critical organs being affected.”
DEVELOPMENT OF THE COOL BRAIN
Utilising years of experience provided by friend and former TCD physics graduate Ian Pointer — as well and Eurolec graduate engineers — a prototype Cool Brain instrument was developed. The challenge was how to evaluate the performance of the invention, as medical ethics does not permit the introduction of a temperature sensor in the brain whilst a volunteer is wearing the cooling helmet. Eurolec personnel decided to carry out a simulation as close as possible to recreating the actual brain being cooled.
A head-sized Tupperware bowl was filled with gel. A heating element was inserted in the centre to create and maintain a heat source similar to blood supply to the head. Four temperature sensors were positioned in the gel approximately 5cm inside the bowl. These recorded and provided a temperature graph whilst the functioning cooling helmet was in place on top of the ‘head’ (Tupperware bowl). The results showed a significant temperature reduction within an hour.
The next step was an in-house test for Mears to wear the helmet and monitor the temperature of the tympanic membrane in the ear. This is as close as one can have a temperature sensor to the brain without medical support or penetration via nasal passages. Again, the results were positive. It seemed that the next step required external evaluation by academics who could objectively evaluate the medical device.
Enterprise Ireland’s Innovation Voucher Scheme allowed the company the opportunity to commission an independent evaluation of the device. A team from the Institute of Neuroscience in Trinity – comprising Eric Lacey, Prof Shane O’Mara, Dr Paul Dockree and Dr Redmond O’Connell – evaluated the Cool Brain. Their full academic report runs to 17 pages and concluded that the device has considerable potential and could greatly benefit patients.
Using a neurologically healthy group of adults, the team examined both the cooling process itself and the effect it had on the cognitive abilities of the participants. On average, each participant’s core temperature was reduced by .62°C, with water circulating in the specially designed cooling cap at a stable 4°C, during a short cooling session.
Whilst this did not produce any significant cognitive changes in the brain patterns of the participants involved, the fact that a temperature reduction was achieved was quite promising. If the circulating liquid temperature were to be cooled to lower temperatures, using a chemical solution to prevent freezing, one might expect an even greater core temperature reduction and possible neuro-cognitive effects.
The Cool Brain system comprises:
- An instrument to control the temperature of the liquid, which circulates in a closed-loop system;
- A hose and helmet with nape-of-neck collar for enhanced cooling and heating, with a ‘snap fit’ connection;
- A temperature controller – a proportional-integral-derivative control provides accurate temperature regulation of the circulating liquid and includes a ‘ramping’ function, to alternate between heat and cold. The temperature can be set from 3°C to 45°C. A separate display permits continuous monitoring of the patient’s temperature in either Celsius or Fahrenheit;
- A nasal cannula option permits the introduction of chilled or heated air via the nostrils.
It includes optional attachments – easily detachable pads/wraps that can be applied to different body parts to ease discomfort, reduce swelling and encourage soft tissue healing in human or veterinary applications. The Cool Brain device operates from its own rechargeable batteries for approximately one hour, but it can also operate from a 12v paramedic vehicle battery or from mains 110/220v. It is also relatively portable and compact, weighing 4.5kg, so it can be used at the earliest opportunity all the way through to intensive care in hospital.
FURTHER DEVELOPMENT AND COMMERCIALISATION
“We’ve been examining methods of modifying the device to improve the performance and also endeavouring to liaise with medical consultants to explore how new different attachments could be designed for other applications,” explained Mears.
“From speaking with a number of experts in neurology and neuroscience in organisations such as Beaumont Hospital and the Royal College of Surgeons, there are a lot of potential applications for the science behind the Cool Brain,” he continued. “One of these would be the transportation of donor organs within strict temperature limits to optimise their successful implantation. At the moment, organs are packed in crushed ice – the goal is to cool but not freeze the organs. Using a device that provides a consistent, accurately regulated temperature eliminates any element of risk, should there be any unforeseen event.”
Mears explained that the technology could also accelerate soft-tissue healing in sports and veterinary applications, with pads that could heat and cool on a ‘ramped’ basis for the required time and temperatures. “The Cool Brain may also be used to minimise discomfort and hair loss during chemotherapy treatments for some cancers. Also, many of the current techniques used involve liquid coolant being introduced through nasal passages. The Cool Brain can be used for veterinary purposes, too,” he added.
Eurolec Instrumentation (together with its associate company, Oriel Medical Devices Ltd) is keen to realise the full commercial potential of the patented device and is currently pitching to interested parties.
“We’re a small company, dipping our toe into the waters of the medical device sector, and we don’t have medical backgrounds,” said Mears. “However, we’re experts in field of temperature control and instrumentation and we have over 30 years of experience in this area. We’re looking for interested parties to fully explore the medical and commercial potential of the technology.
“I’m interested in hearing from organisations that have experience with medical devices and their route to market and perhaps carry out more extensive live trials to determine all of its benefits,” Mears concluded.
See www.eurolec-instruments.com for more information.http://www.engineersjournal.ie/2014/01/16/irish-medical-device-helps-patients-to-keep-a-cool-head/http://www.engineersjournal.ie/wp-content/uploads/2014/01/160382211-1024x703.jpghttp://www.engineersjournal.ie/wp-content/uploads/2014/01/160382211-300x300.jpgBiomedical devices,research