Sextant
A Clinical Guidance Tool
Product Development
Neomedix Systems (NMS), had prior to
1997, been associated through the supply of
equipment, with an Australian tertiary hospital
Intensive Care Unit which has been developing a
numeric control approach to the management of
the patients circulation.
Stabilising the
newly admitted ICU patient and the subsequent
circulatory volume management is frequently a
complex activity and absorbs 40% of the
intensive care staffs attention. There is
currently no unified or universally accepted
method of managing the circulation although many
attempts have been made to provide this.
The
ICU involved uses a servo control technique,
which utilises volume as the control target to
successfully manage the difficult task of
circulation control in these critically ill
patients. Of particular difficulty is the
control of the volume state when patients are
undergoing bedside renal dialysis. This unique
management process was initially applied where
the patients clinical status called for an
alternative to the conventional approaches to
circulatory management. It has however now
become the routinely adopted method of managing
the circulation. Clinical papers utilising this
process have been published including that of a
critically ill patient group of ICU patients
also undergoing bedside CVVHD haemofiltration.
The increasing shortages of trained clinical
ICU staff, is causing the bedside monitoring
manufacturer to consider provision of devices
which not only monitor, but also provide
advisory guidance to the clinician with respect
to the undertaking of related interventional
therapy.
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With this background, the decision was made by
Neomedix Systems in 1998 to undertake
R&D with respect to the equipment required to
facilitate numeric control of the blood volume
and to then commercialise the product
(Sextant). Commencing in 1999 as a
$2.0 million AUD R&D project, with support from
an Australian Federal Government R&D Start
grant, the R&D Project was undertaken and
successfully concluded with two series of pig
trials during late 2002. These animal trials
were carried out by Amtec (a Biomedical
Research unit) located in the dept of
Medicine at Sydney University, managed by
Prof. Colin Sullivan (the inventor of the
commercially successful CPAP product now
produced by Resmed Inc). These 'proof of
concept' experiments using Sextant
prototypes proved the ability of the
technique to provide predictable numerically
controlled management of the circulation in the
face of deliberate gross alterations to the
animals blood volume. Sextant will
provide unique bedside information pertaining to
the circulation via an innovative process
utilising four commonly recorded vital sign
parameters derived from an existing bedside
monitor and also the output from three
additional (unique) Sextant measurement
devices, for which no commercial product is
currently available. The clinician is then
provided with two currently 'missing'
physiological parameters, crucial to predictable
numeric control of the circulatory volume. The
initial release product will be a circulation
specific status display used by the physician as
an advisory/guidance tool. It is intended to
later provide a version for closed loop
circulation control, which is anticipated to by
then be viewed in much the same way that an
autopilot is expected for the complex control
requirements on modern aircraft.
Partnering Opportunities NMS is a
privately owned Biotechnology SME and is
interested in forming on-going, strategic
relationships complementary to the opportunities
presented by development of these products for
the Intensive (or Critical) Care Unit and,
perhaps separately, for its activity in the pre
and post operative Urogynaecology markets.
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