Syringe pump design

PAUL WADHAM Vickers Medical, Basingstoke

With the evolution of special care baby, intensive care, and coronary care units over the last decade, there has
developed a need for greater accuracy in the control of increasingly potent infusions.
The design of bedside syringe pump infusers that administer the contents of a syringe to a patient at a constant
and predetermined rate will b e considered in terms of their ergonomics, control, and safety.
Syringe pump design has evolved over the past few years from simple mechanised forms of syringe driving to
very sophisticated and precisely-controlled drive systems capable of high volumetric accuracy over a wide range
of clinical conditions and sustained for long time periods. This has led to the development of new and critical
forms of drug therapy.
In addition, important progress has been made in the safety and reliability aspects of syringe pump design.
Modern syringe pumps are expected to have fail-safe electronics to protect the patient in the event of a fault
occurring. With the advent of modern microprocessor techniques, future syringe pumps can be expected to
incorporate further sophisticated operational.and safety enhancements, whilst remaining simple to operate.
Typical safety enhancements could include the incorporation of a variable pressure sensor to protect against
unwanted pressure build up in the IV line, the use of absolute linear encoding techniques for control and
monitoring of the infusion, and the increasing use of self-tests and diagnostics to aid the user.
Operational enhancements could include the ability to support pharmacokinetic techniques, as well as closed
loop drug therapy and remote computer control.
Whilst this suggests that infusion therapy might become too sophisticated for day to day use, comprehensive
interactive instructions and diagnostic aids would contribute greatly to ease of use.
Good user training will be of increasing importance to maximize the benefits of the advances in syringe pump
design.

ERGONOMICS THE EVOLUTION OF THE SYRINGE PUMP DRIVE MECHANISM

The phrase ‘good ergonomics’ although overused, is one
which is particularly relevant to syringe pump design.
Early syringe pumps tended towards engineering exer-
cises in the area of fluid delivery, often with the minimum
of patient safety features and controls. As the designs
improved, so the products were to be found in the
broader context of patient care, from general ward use to
critical care environments.
Syringe pumps have developed to the stage where they
are expected to be used in an increasingly wide range of
clinical conditions by an ever broadening staff spectrum.
To achieve this the pump must be simple to operate,
ideally even for someone without specific training. The
controls should be clear and easy to interpret. Setting the
rate, for example, should be done in ml/hr and not left to
the user to calculate in terms of axial travel.
All the pump controls should, ideally, be in view
during normal use to provide as much information as
possible about the infusion.
Such a user-friendly philosophy, together with inher-
ent simplicity, are important facets for a safe product. A n
example of this is the replacement of mechanical rate
switches with Light Emitting Diode (LED) or Liquid
Crystal Displays (LCDs) linked to a membrane switch
panel providing better-disseminated information. This
has been made possible by advances in electronic design
coupled to cheaply-available microprocessor power.
The layout of pumps has also improved. Early designs
were more compromised to meet the packaging needs of
the transmission and electronics. With the advent of
widely available moulding techniques, and suitable
structural materials, designers may now present the
package in an optimal fashion. ‘Surface mount’ printed
circuit board technology and smaller more powerful
electric motors have combined to allow designs laid out
in such a way that all controls and information are
immediately apparent to the user.
( MEP Ltd 1986 VoI 15. No 4
One of the first claimed designs for a syringe pump was
the ‘rubber band’ driven pump. This worked on the
simple ‘slingshot’ principle and was evidently unsatis-
factory for many reasons, not the least of which was the
arbitrary rate at which the infusion occurred.
The next generation of syringe pump designs was
based around the clockwork mechanism. This type of
pump exhibits the fundamental features of all subsequent
designs, a drive mechanism which can be divided into
two parts, the first being the source of motive power for
the infusion. Initially it was a simple rubber band and
later a clock spring. The second feature is a transmission,
designed to convert the power source into axial move-
ment of the syringe plunger. This combination needs to
be consistent over a wide range of parameters, most of
which are not pump related: syringe size, friction, fluid
viscosity, and infusion pressure.
Whilst clockwork or spring driven pumps were
capable of providing sufficient motive power, early
designs were limited in their ability to control accurately
over the increasingly wide range of clinical conditions.
Designers quickly moved on to exploit small but power-
ful electric motors of which there are two types: the
stepper motor and the d.c. motor. Modern versions when
coupled to a reduction gearbox are more than capable of
providing sufficient motive power whilst affording
precise control.
In the case of the stepper, this control is achieved
through the relationship between one pulse and the angle
the motor subtends equating (via the transmission) to a
specific movement of the syringe plunger. A d.c. motor,
on the other hand, requires some system of encoders to
allow this relationship between motor revolutions (or
fractions of) and plunger movement.
The layout of the drive system is often dictated as
much by the constraints of packaging as those of per-
formance. Two different transmissions have been most
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Early designs utilised conventional circuit boards and

frequently used, the rack and pinion (Fig. l(a))and the
leadscrew (Fig. l(b)). The rack and pinion allows the
motor to be perpendicular to the syringe axis, whilst with
the leadscrew layout the motor is arranged parallel to the
syringe axis. Whichever is used. it must be inherently
linear to provide sufficient accuracy for long term infu-
sions. A method of disengaging the drive must also be
included to allow syringes to be loaded and unloaded,
whilst the drive system must offer the user a wide range
of precise flow rates (typically 0.1-99.9 ml/hr in 0.1 ml/hr
increments) to meet the increasingly sophisticated drug
regimes and clinical situations.
CONTROL TECHNIQUES
The control technique for all electrically driven syringe
pumps is exceedingly similar. For a given syringe
mounted on the drive system, i t will require a specific
number of motor revolutions to provide the correct rate
in millilitres per hour. I n the execution of this trans-
lation, there is only one simple calculation.
Once the infusion is underway, this converts into a
simple closed loop system of measurement, comparison,
and correction. Any error in this continuous process will
lead to oscillation, requiring the addition of a n integral
term to d a m p this out.
Whilst motor control is the primary function of the
pump electronics, patient safety parameters such as
pumping pressure and end of travel are also monitored
(Fig. 2).
172
discrete component technology to achieve this. As the
circuit logic became more comprehensive (Fig. 3) so the
layout tended to require complex boards which were
large, difficult to package, and expensive t o produce.
With the advent of the microprocessor, a more sophis-
ticated network of controls could be built into the design
on a more simple layout, with the complexity shifting
towards the software. Here risk is associated with the
way in which software is written, and there is always an
oblique chance that the microprocessor may itself be
fa 11It y .
This then leads to the optimum configuration o f a twin
microprocessor system. in a master and slave configu-
ration. This, as its name suggests. provides a simple
circuit with enormous processing power with one con-
trolling the motor and the second checking for faults.
Microprocessor faults are avoided by each sending the
other test routines. To avoid the unlikely event of both
microprocessors hanging up, a hardware watchdog has
to be regularly reset, or i t shuts down the motor.
In terms of packaging advances, there are several new
technologies which can now be utilised to reduce the
impact that the control board has on the pump design.
The advent of surface mount, where components are
smaller due to their interconnection by pad rather than
leadwire, has dramatically increased the packing density
of board layout. Often a reduction of four times in area
can be achieved. Beyond this lies hybrid technology,
where components are replaced almost entirely by thick
Engineering in Medicine I MEP Ltd 1986

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film ‘inks’ of material. This yields greater area savings,
but its financial justification requires high volume pro-
duction. Finally, ‘custom chip’ offers the ability to place a
major part of the circuit ‘into silicon’ offering enormous
space savings but at very high initial cost, coupled to a
circuit design which must remain fixed.
SAFETY AND RELIABILITY
Syringe pump design has been considered above in terms
of ergonomics, the drive system and control techniques,
but none of this is useful unless the pump is reliable and
safe.
These two facets of the design are closely linked in
terms of component failure which may not only cause the
pump to stop working, but could cause undesirable
behaviour. Here, experience guides the designer to avoid
components which are known to be unreliable, but the
tendency to build fault-tolerant circuits must be meted in
terms of the software being able to detect and act upon
such faults.
Early syringe pumps featured minimal safety systems
to protect the patient in the case of a malfunction. As
devices have been used in increasingly sophisticated
environments, so better and more comprehensive safety
systems have been developed.
The pump should be ‘tamper-proof’ to avoid acciden-
tal interruption or corruption of the patient’s treatment.
This suggests that the drive system should not be capable
of being disengaged during infusion without alarm. I t
should also not be possible to change the rate during
infusion.
A n obvious point is that the pump should not be
capable of being run with a zero rate selected. The
control circuitry should also self monitor to check
against internal malfunctions. Some early designs could,
under certain conditions, be induced to operate without
proper control of the infusion rate.
Other safety systems should minimize the time spent
attendant at the pump. An example of this is ‘end of
infusion’, where early designs had an alarm to warn the
user only that the infusion had ended. New designs
feature a ‘keep vein open’ rate where, a few millilitres
from the end, the pump alarms and automatically goes
onto a low rate. This both provides time for the next dose
preparation and keeps the site patent.
Probably the most important system in a pump design
is its capability of detecting the occlusion at the IV site,
caused by say, positional IV where the cannula becomes
misplaced and tissue infiltration occurs, a kinked or
twisted extension line, or clotting.
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F i g . 4 . Open-loop systemfor programmed injiisions
( MEP Ltd 1986 Vol 15, No 4
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All these interrupt the normal course of the infusion
and could be potentially harmful. Modern pump designs
feature pressure monitoring methods to detect the high
pumping pressure in the syringe and line under such
conditions.
Finally the pump should warn if the power source is
removed or fails. This is particularly relevant to modern
a.c. powered designs which feature automatic battery
back up. Here it is imperative that, in the case of a.c.
power failure, the user is warned that the pump is contin-
uing to infuse on battery power.
FUTURE ENHANCEMENTS
The benefits of the technological advances outlined
above are likely to manifest themselves in terms of oper-
ational and safety enhancements.
To achieve a high degree of volumetric accuracy users
have generally been limited to an infusion pump which
will accept only one manufacturer’s type and size of
syringe, a factor which is limiting both in terms of
medical and financial constraints. New designs will be
capable of providing this whilst accepting a wide range of
syringe makes and sizes with perhaps automatic recogni-
tion. Similarly, a preset occlusion alarm level is almost
an ‘industry standard’. Again the next generation should
have the facility to set the alarm level to suit the clinical
situation; a feature particularly relevant in the field of
intensive and neonatal care where long term site patency
and closer control of pumping pressures are sought.
All these advantages could be lost as unwanted com-
plications unless the ergonomics of new designs do not
keep pace. Multiple character alphanumeric LCDs are
already in use to provide prompts for assistance in
setting the infusion up. This usage will expand to providc
full assistance, both in setting up, identification of alarm
conditions, and in diagnostic help for fault finding.
Clinical regimens are advancing in line with infusion
pump technology. Current practice revolves around
constant-rate open-loop infusions (Fig. 4), a concept
which fails to account for varying efficacies of drugs and,
of course, differing patient conditions. Pharmacokinetics
are developing into non-constant rate infusions coupled
to closed-loop control (Fig. 5). Current technology will
limit new designs to interfaceable solutions, where a
syringe pump is linked to a computer and monitoring
equipment to close this loop. Inevitably miniaturisation
will allow an infusion pump to offer all this within the
confines of one single piece of equipment.
Safety enhancements are likely to be less immediately
apparent to the user. Control circuitry is already
designed to catch single fault failure at component level,
t
Fiy. 5 . Integrated closed-loop injiision system
173
and, as previously discussed, the advent of cheap micro-
processor power has produced powerful and capable
control circuits. The associated software, whilst signifi-
cantly more important, is already heavily scrutinized for
most internationally recognized standards approvals.
Future work is likely to concentrate in the areas
associated with pump safety and control circuitry. Par-
ticular emphasis will be placed on the rate and syringe
travel monitoring, coupled to more sophisticated alarm
protection.

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