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In
1999, researchers in the Electronic Engineering Department of
Bolton Institute (home of the Electronics Design North Support
Centre), working with the Department of Emergency Medicine at
the University of Manchester, published results of experimental
work on pyroelectric polymers (PEP), which demonstrated the
feasibility of measuring breathing rate using a small piece
of PEP film incorporated into a face mask. The film was shown
to generate an open circuit output voltage, typically around
250mV, related to the temperature differential between the inhaled
and exhaled breath. This voltage, after amplification, sampling
and processing was able to drive a numerical display of the
breathing rate. Preliminary trials of an experimental breathing
monitor using this approach and designed by the Support Centre
were conducted at Hope Hospital A&E Department and these
were so encouraging that the Institute resolved to seek ways
of exploiting the discovery commercially.
An
approach was made to really Smart ideas ltd (rSi), a local company
specialising in the translation of innovative healthcare ideas
into saleable products. rSi was impressed with the combination
of experimental results and clinical trials and, with the help
of the Support Centre and discussions with medical advisers,
was able to confirm the feasibility of developing a practical
breathing monitor based on the PEP sensor. Within 12 months,
rSi and the Institute had set up a joint venture company, c-Lect
Medical ltd, to develop prototypes and a marketable product.
Meanwhile, the Support Centre produced initial prototypes of
the equipment for additional clinical trials at Rochdale Infirmary.
These served to confirm the potential of the proposed product
and results were reported at a major conference of anaesthetists
in July 2002.
In
Jan 2002 c-Lect medical ltd was awarded a SMART Development
Grant to take the project further and, with ongoing help from
Support Centre engineers, has now developed the first basic
model of a practical, low cost, safe, accurate and easy to use
monitoring system. This is based on a standard oxygen mask fitted
with a PEP pyroelectric device. The electronics are based on
the original experimental equipment developed by the Support
Centre, with the addition of high and low level alarm triggering
to summon emergency help. Facilities are provided to add other
functions at a later date should customers require them. Manufacture
of the prototypes has been subcontracted to a local company.
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Plans
to market this novel sensor are now at an advanced stage and
a distribution agreement has been signed with Viamed Ltd,
a leading medical devices specialist, as a result of which
prototypes of the equipment (now called the Pippa Breathing
Monitor), were exhibited at Medica, Düsseldorf, in November,
2002 and at Arab Health, Dubai, in January, 2003. They attracted
a great deal of interest. Battery powered and with an acoustic
alarm, which sounds if breathing rate falls below 8 or rises
above 30 breaths per minute, Pippa provides either an instantaneous
reading, or an average reading based on four consecutive breaths.
c-Lect
medical ltd expects certification testing to CE standards
to be completed during April 2003, so that this innovative
medical instrument could be on the open market. Applications
envisaged include patient monitoring in A&E Units, paramedic
ambulances, medical wards and obstetric units. The North Support
Centre continues to provide expert electronics support, helping
c-Lect medical ltd to exploit what could well become
the most successful medical instrument of its kind worldwide.
Images
(Click on images to enlarge)
The
Pippa breathing monitor shown with two examples of patient
mask
George
Steele, Technical Director and Dick Badami, Research Director
of c-Lect medical receive their Smart Award 'statue' at a
formal presentation in November 2002.
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