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Accurate Low Cost IV Infusion Control

R E S E A R C H I N F O R M A T I O N

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Market Focus 3The Problem 4The Solution 8The Acuset IV Flow Controller 9The Acuset Disposable IV Set 14The Acuset Self Compensating IV Bag 16

Research Data 19Acuset IV Flow Controller 20Acuset IV Drip Set 22Acuset Self Compensating IV Bag 27

Contents

Market Focus What problem are we solving?

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The ProblemIntravenous Infusion Therapy (IV Therapy) is the most common medical procedure worldwide.

In the developed world electromechanical infusion pumps are used to deliver medicines with a high degree of accuracy and precision. However these pumps typically cost USD$2,500 and must be connected to a stable continuous power supply and routinely calibrated and serviced. Due to their high capital and on-going maintenance costs these devices are not commonly used in developing world hospitals or the developed world homecare market. In the developed world gravity infusion sets are typically used in hospitals or rest homes for all non-critical IV infusion treatments. While in the developing world setting gravity infusion sets are used to administer highly potent medicines using the gravity infusion sets primitive roller clamp mechanism to set and control flow rates. See below photo of typical roller clamp – tubing configuration.

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The traditional roller clamp controller is not intuitive to use and has a highly sensitive and random adjustment mechanism. Even trained medical staff have difficulty in setting and maintaining accurate infusion rates.

Independent clinical trials have shown that nursing staff spend up to 17% of their nursing time conducting regular checks and changing infusion rate settings to maintain prescribed infusion rates.

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Numerous clinical studies have shown that in a typical hospital setting the accuracy of gravity infusion treatment is very poor (ref 1,2,3,4,5).

Typically only 15 - 20% of patients receive flow rates within 10 - 20% of their prescribed rates and some patients may receive up to 160 X their prescribed flow rates.

In the developed world clinical setting the inherent inaccuracy of gravity IV infusion sets may result in the following adverse clinical outcomes, phlebitis, thrombosis and fluid extravasation.

In the developing world setting the inherent inaccuracy of gravity infusion systems results in avoidable under or over administration of potent medicines such as antibiotics, chemotherapy and hypnotic drugs which results in concomitantly high rates of patient morbidity and mortality. The aging population growth in the Asia Pacific Region has placed added strain on hospital and homecare nursing staff who do not have time to constantly monitor and adjust Gravity Infusion Sets.

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Nurses and Hospital Beds

Wes

tern

Eur

ope

East

ern

Euro

pe

Nor

th A

mer

ica

Sout

h Am

eric

a

Asia

Pac

ific

Afric

a

Hospital Beds Nurses

Mill

ions

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Existing Infusion Treatment Technology applications have inherent problems compared to the AIS Technologies application.

PRODUCT CHARACTERISTICS INFUSION PUMP

STD IV ROLLER CLAMP

SAFEGUARD IV SET

Free Flow Possible No Yes No

Over-delivery Possible Yes Yes No

Automatic Shut-off Possible Yes No No

Computer Malfunction Possible Yes No No

Mains Power Failure Possible Yes No No

Accidental Mechanical Force Possible Yes Yes No

EMI Possible Yes No No

Low Cost No Yes Yes

Intuitive to Use No No Yes

In simple terms the current roller clamp IV adjustment system is very crude requiring resistive pressure from the tubing to hold the roller clamp in place. Changes in temperature and or cold flow creep can cause the clamp to open spontaneously resulting in “free flow” whereby all the contents of the IV bag are transfused in a matter of minutes rather than hours. For patients receiving IV infusion treatment this may result in a physical subcutaneous bolus of fluid or life-threatening hyponatremia.

Free flow of potent chemotherapy or hypnotic drugs may result in death. There is therefore a critical need for an improved low cost “set and forget” Gravity Infusion System which is intuitive to use and has a high degree of safety, accuracy and precision.

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The SolutionThe AIS technologies comprises of three complimentary technology solutions which solve the inherent inaccuracy of current proprietary Gravity Infusion Sets. When used in combination the AIS IV infusion system provides similar accuracy to an electromechanical infusion pump.

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The Acuset IV Flow Controller The Acuset IV Flow Controller replaces the current highly inaccurate gravity IV infusion roller clamp.

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1. Body2. Spring3. Cam Follower4. Adjustment Cam5. Clicker mechanism6. Adjustment dial7. Securing screw8. Back plate9. Label

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Acuset Die SetAIS has manufactured and validated commercial scale production dies to manufacture the Acuset IV Flow Controller”

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Key benefitsThe Acuset controller versus the conventional roller clamp IV controller.

PARAMETER ACUSET CONTROLLER

ROLLER CLAMP CONTROLLER

Intuitive to Use Yes No

Micro Control High Accuracy/Precision Yes No

Reusable Yes No

Reduced Cold Flow Creep Yes No

Has Calibrated Visual Guide to Settings Yes No

Reduced Adjustment Time Yes No

Can be easily used by patients Yes No

Can be adapted for various clinical situations Yes No

Auditory Feedback of Setting Yes No

Patented Technology Yes No

Lower Management Costs Yes No

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Market Segment Applications

The Acuset controller can be easily adapted to a variety of markets and applications with very simple and low cost changes.

COMPONENT VARIABLES MARKET SEGMENT TREATMENT

Cam

sha

pe/c

am fo

llow

er/d

imen

sion

s/co

lour

mat

chin

g

Hospitals Adult high flow rate Rehydration

Hospitals Adult low flow rateChemotherapy/anaesthesia/Cardiac/antibiotic

Hospitals PaediatricChemotherapy/anaesthesia/Cardiac/antibiotic

Homecare Adult low flow rate Palliative care

Veterinary Small animalChemotherapy/anaesthesia/antibiotic

Veterinary Large AnimalChemotherapy/anaesthesia/antibiotic

Veterinary Small and large animal Rehydration

Dial

Gra

phic Hospitals Paediatric

Chemotherapy/anaesthesia/antibiotic

Hospitals AdultChemotherapy/anaesthesia/antibiotic

In addition, the Acuset Flow Controller may be produced as a sterile, single pack, ready to use morphine administration set for acute medical and military use.

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The Acuset Disposable IV SetThe Acuset Drip Set is manufactured from non PVC materials and contains a section of highly flexible silicone tubing which is clamped into the Acuset IV Flow Controller.

The Acuset Disposable Drip set is specifically configured to only fit the Acuset Flow Controller which ensures an ongoing product revenue stream.

The conventional proprietary IV Drip Set tubing is typically manufactured from PVC or an alternative non plastic tubing which is compressed along its length by a roller clamp and this compression exhibits considerable cold flow creep resulting in significant changes in set flow rates over time.

Typically cold flow creep may result in an overall 50% decrease in the set flow rate over a four hour infusion period.

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A. Acuset IV Drip Set flexible silicone tubing

B. Non silicone tubing compressed using a roller clamp exhibits considerable cold flow creep resulting in significant changes in set flow rates over time.

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The Acuset Self Compensating IV BagThe Acuset Self Compensating IV Bag utilises Patent Pending Technology to compensate for the inherent drop in hydrostatic pressure as the IV bag empties.

Irrespective of the accuracy of any Gravity Infusion Control Device is the overriding inaccuracy of conventional gravity IV infusion therapy due to the inevitable reduction in hydrostatic pressure resulting from the emptying of the IV bag contents over time.

The Acuset Self Compensating IV Bag compensates for the change in hydrostatic pressure as the IV bag empties providing a near linear consistent hydrostatic pressure throughout the IV administration time.

The Acuset Self Compensating IV Bag comprises of a conventional non PVC IV bag to which is thermo welded, or mechanically attached, a novel elastomeric pharmaceutical grade polypropylene (PP) and styrene ethylene butadiene styrene (SEBS), ethylene vinyl acetate (EVAM), polypropylene and copolyester ether cord.

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How it WorksEssentially the elastomeric cord acts like a rubber band raising the height of the IV bag as the bag empties thereby compensating for the concomitant drop in hydrostatic pressure.

However, unlike a rubber band the patent pending polymer cord provides a near linear compensation in hydrostatic pressure as the IV bag empties.

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1. Elastomeric cord stretches linearly under the weight of bag

2. As the bag empties the elastomeric cord lifts the bag up

3. Constant hydrostatic pressure maintained (dotted line).

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The cross sectional area of the cord may be adapted to compensate for the hydrostatic drop in pressure in 1000ml and 500 ml IV bags or to compensate for IV solutions of different Specific Gravity (density).

Pressure Heading Effect Comparison

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Current Practice IV Bag with proposed elastic compensation

Volume of IV administered (ml)

Pres

sure

hea

d co

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Above: Pressure heading effect comparison between a statically hung IV bag and one with elastic pressure heading compensation.

Research Data

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Acuset IV Flow ControllerThe graph below illustrates the significant difference between the Acuset Controller adjustment range and a standard Roller Clamp Controller.

Adjustment Sensitivity of Flow Controllers

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125

Roller Clamp Acuset

Amount of Travel (mm)

Flow

Rat

e (m

ls/H

R)

The typical IV infusion range for adults is 60 to 125ml per hour and as may be seen from the graph the roller clamp adjustment range to achieve these setting is from 6 - 7mm (1mm).

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In comparison the effective adjustment range for the Acuset Controller for 60 - 125 ml per hour infusion rate is 23 - 28 mm (5 mm).

The overall “slope” of the adjustment range is significantly steeper for the Roller Clamp than the Acuset meaning that even very small movements of the roller clamp result in large changes to the overall drip set flow rate.

For neonatal IV infusion rates the limited adjustment range and steep “slope” mean that it is near impossible to accurately administer accurate Neonatal Gravity Infusion using a roller clamp mechanism.

Viz. Typical IV Infusion Rates for neonates are between 6 - 40 mls per hour which equates to roller clamp adjustment rate settings of 1 - 2.5 mm.

In contrast the Acuset cam shape has been specifically designed to accommodate neonatal and adult infusion rates. So to deliver neonatal IV infusion rates of 6 - 40 mls per hour the Acuset settings would range from 6 mm - 20 mm.

The Acuset IV system controller is therefore significantly more accurate with respect to the setting and control of accurate Gravity Infusion Rates.

Note, it is possible to further improve the accuracy of the Acuset controller by changing the shape of the adjustment cam for specific applications. e.g. neonatal care – drug administration.

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Acuset IV Drip SetThe control of IV fluid using a standard IV set is exclusively dependant on compressing the IV tubing and reducing the cross sectional area of the tubing by means of a roller clamp mechanism which is effectively a resistive clamping mechanism.

However, the materials of construction of standard IV drip sets exhibit a high degree of “cold flow” creep resulting in a constant decrease in IV infusion rate over time.

When clamping the IV tubing the roller clamp exerts high levels of energy onto the standard IV drip set tubing. The majority of this energy is stored in the IV set tubing and slowly released as kinetic energy causing the tubing to continue to deform even when the position of the roller clamp remains constant.

This phenomenon is referred to as “cold flow” creep.

Each adjustment of the tubing using the roller clamp exerts more cold flow creep onto the tubing resulting in unpredictable changes in flow rates over time.

Cold Flow Creep may result in a 50% decrease in IV flow rate over 4 hrs.

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The Acuset IV drip set eliminates the effect of cold flow creep through the inclusion of a highly plastic section of silicone tubing which fits into the clamping area of the Acuset controller.

Cold Flow Creep - Standard IV TubingHydrostatic Pressure Constant

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80%

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2 32 62 92 122 152 182 212 242

Drops Per Minute % Variance to Average

Minutes

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The Acuset IV Drip set requires nearly 800% less energy to compress the IV drip set tubing compared with the standard IV drip set tubing which minimises the effect of cold flow creep.

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Force to compress tubing to closedAl

aris

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Alar

is O

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ford

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ec

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ical

Stan

dard

so

ft

Stan

dard

Force (Newton’s)

Tubing

3.92 3.92 3.92 3.92 5.88 27.44 34.3

0% 0% 0% 0% 50% 600% 775%Additional Force %

Silicone tubing versus standard tubing: 18 celsius - 4.5mm bar

In combination the AIS Technologies package provides similar accuracy to an electromechanically microprocessor controlled IV infusion pump which typically costs USD$2500.

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The graphs below show a proprietary Gemini Infusion Pump flow rate compared with the AIS Technologies system incorporating the Acuset IV Controller, Acuset IV Drip set and the Acuset self-compensating IV bag.

Gemini PC-1 Infusion Pump

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1 6 12 17 23 28 34 39 45 50 56 61 67 72 78 83 89 94 100 105 111 116 122 127

Drops Per Minute % Variance to Average

Minutes

Sigma = 1.26%

AIS Technologies Flow Rate Technology over time

Ipotec + IVF #31

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1 15 28 55 69 82 109 123 136 163 177 190 204 231 244 255 285 298 312 339 352

Minutes

Sigma = 0.36%

Drops Per Minute % Variance to Average

Drops Per Minute % Variance to Average

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Extremely Low Flow Rates Possible:

• Using the AIS Technologiesvv IV system extremely accurate low IV infusion rates are possible.

• The graph below shows a near constant infusion rate of 0.15 mls per minute over 4.5 days’ timeframe.

NOTE: Typical infusion rates for neonates are between 0.15 - 0.6 mls per minute, making the AIS system suitable for neonatal IV administration.

Safeguard IV System + IV Flow HP Controller

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Low Flow Rate over time - Variable Temperature - Start time: 15h30

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Acuset Self Compensating IV BagThe principle of gravity infusion treatment is that the gravity of the IV fluid in the IV bag “pushes” the IV fluid down though the IV tubing and into the patient’s vein via a cannula.

The higher the IV bag is hung above the patient’s heart the greater the pressure exerted and the greater the potential IV flow rate.

To overcome the patient’s normal venous pressure and to allow fluid to pass into the bloodstream the IV bag will be located a minimum of 900 mm above the patient’s heart.

One of the overriding factors which effects the accuracy of all Gravity Infusion treatments is that as the IV bag empties during the IV Infusion procedure the pressure applied to IV system decreases.

Pressure components for an IV bag with elastic pressure heading compensation

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Pressure drop due to bag emptying

Pressure rise due to elastic

IV Bag with proposed elastic compensation

Volume of IV administered (ml)

Pres

sure

hea

d co

mpa

red

to in

itial

(mm

)

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This causes a decrease in the set drop rate which has to be compensated by constantly readjusting the roller clamp mechanism to maintain a constant drop rate setting.

Hydrostatic Pressure Effect

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% Variance to Average

Minutes

10-20% decline in flow rate

This is further complicated by changes in the patient’s position.If the patient is lying down when the IV drip rate is set up and then the patient sits up the infusion rate will slow down because of the increase in venous pressure, “backpressure”, applied to the gravity IV drip set system.

In combination the decrease in hydrostatic pressure due to the emptying of the IV bag contents and the changes in venous back pressure applied to the IV system via patient movements can cause significant changes in the prescribed IV infusion rate over time.

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Utilising the Patent Pending linear stretching elastomeric cord, which is an integral part of the Acuset SC IV Bag, the height of the bag is raised in a near linear fashion to compensate for the drop in hydrostatic pressure.

1

2

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1. Elastomeric cord stretches linearly under the weight of bag

2. As the bag empties the elastomeric cord lifts bag up

3. Constant hydrostatic pressure maintained (dotted line).

Therefore In the AIS Technologies system the Acuset Self Compensating IV Bag compensates for the drop in hydrostatic pressure caused by the emptying of the bag contents.

With respect to changes in hydrostatic pressure cause by patients’ movements this may be mitigated through IV infusion treatment Standard Operating Procedures.

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For neonatal patients changes in hydrostatic pressure are insignificant as the patients are confined in the supine position.

For outpatient IV infusions, which are common in China, patients are treated in a sitting position so changes in hydrostatic pressure due to patient movements are also insignificant.

For hospital and rest home patients a Gravity Infusion Treatments Standard Operating Procedure should be in place to minimise the effects of changes in venous pressure due to patients moving from the supine position to sitting or standing up.

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References

1. Bivins BA, Rapp RP, Powers p, et al. Electronic flow control and roller clamp control in intravenous therapy: a clinical comparison. Arch Surg. 1980;115 (1) : 70-2.

2. Crass RE, Vance JR, In vivo accuracy of gravity-flow i.v. infusion systems. Am J Hosp Pharm. 1985;Feb:42:328-31.

3. Flack FC, Whyte TD. Behaviour of standard gravity-fed administration sets used for intravenous infusion. Br Med J. 1974;3:439-43.

4. Rithalia SV, Rozkovec A. Evaluation of a simple device for regulating intravenous infusions. Intensive Care Med. 1979;5:41-3.

5. Bissett IP, Brandt TP, Windsor JA. Survey of Intravenous Fluid Therapies and Accuracy of Gravity-Fed Infusions in a Teaching Hospital. Samoa Medical Journal (Online). 2010;vol2 (2):25-28.