iPRECIO SMP-200

The World’s First Totally Implantable, Programmable Micro Infusion Pump for Small Animal Infusion

• Accurate patented Rotary Finger Method
  • Every pump is factory tested and calibrated
    Better than ±5% accuracy
  • 0, 0.2, 0.5 and 1.0µl/hour to 30.0 µl/hour in 0.1µl/hour steps
    294 discreet infusion flow-rates
  • Programmable infusions protocols (simple and complex)
  • Battery life of up to 6 months (continuous 1.0µl/hour)
• Totally implanted in subcutaneous space
• Refillable (reservoir) percutaneously via refill port with re-sealable septum
• With iPRECIO^® catheters, test your drug’s effects nearly anywhere
• Easy to use menu driven software for infusion protocol programming

Benefits of iPRECIO^®

Accurate infusion at programmed time points

• Better than ±5% accuracy of programmed flow-rate

Programmable Infusion Rate

• Recovery Period
• Dose Escalation/De-escalation Studies
• Wash-out periods
• Complex Infusions (daily/weekly repeat dosage, circadian rhythm, ……… )

Complex pharmacokinetic and tolerance studies based infusion protocols including constant continuous dose, circadian rhythm infusion to complex “oral dosage simulations” three times per day. Further, iPRECIO^® enables to test the relevance of dosing time or dosing protocol on the therapeutic index of small and large molecules.

Refillable

• Multiple drugs
• Multiple solvents/vehicles
• Multiple concentrations of drug(s)

Increase study effectiveness by testing multiple drugs/vehicles within one animal. This enhanced flexibility is made possible by using wash-out periods between drug administration when only saline is infused to keep catheter patent.

Combination of Refillable and Programmable makes iPRECIO^® an extremely flexible and versatile infusion pump.

Implantable

• Tetherless free moving animal model.
• No exit wounds. (reduced infection risk)
• No wires or connections to animal to allow stress free infusion.

Combined with Drug Infusion and Telemetry Bio-Signal Measurement

iPRECIO^® implantable micro infusion pumps will provide benefits of syringe pumps and other implantable pumps combined in one unit. In combination with this gold standard of telemetry, sophisticated implantable infusion pumps will lead to ever more sensitive and powerful means of detecting drug induced therapeutic and/or adverse effects.

Implantable

The pump can be completely implanted in small laboratory animals subcutaneously.
Thus, the animal moves freely without any restrain (i.e. tethering) during drug infusion.
Additionally, infection risk is reduced, and the animal is likely to be significantly less stressed than in a tethered infusion model.

Refillable

You can replenish any medical fluid in the pump via percutaneous access to the pump refill septum and reservoir after implantation of the pump.
So, long-term drug infusion can continue until the installed battery life has run out.
The reservoir is elastic and configured in such a geometry as to allow gentle palpation to confirm an approximate level of fluid in the reservoir.

Programmable

Using the easy to use menu driven iPRECIO software, header information along with infusion protocol details are entered and ultimately downloaded to the pump’s flash memory. Start Time, End Time, Flow-rate (1.0µl/hour to 30.0µl/hour), Constant and Variable infusion mode are programmable. Both Constant and Variable infusion options have Instant or Recovery Mode Infusion settings.

In Variable infusion mode, 10 flow-rate steps are user programmable. Further sophistication may be obtained by using iPRECIO’s Repeat Mode where the 10 steps are programmed within one or several repeat cycle loops (5 loops maximum). Each loop may be repeated 2-250 times.*

The programmable feature will make iPRECIO pumps indispensable for applications where accurate flow infusion, recovery/washout periods, constant/variable dose or complex circadian infusion studies are necessary.

*subject to battery life

Infusion Mode

1. Instant Infusion:

Start infusion of the drug instantly by pre-programmed protocol following activation of the pump drive.

2. Post Recovery (Delayed) Infusion :

Start Infusion of the drug after reservoir contents are exchanged percutaneously following recovery period from implantation surgery by pre-programmed protocol. The pump infuse saline or buffer during the recovery period.

When using Post Recovery Mode, user will need to input both RCV Setup (start time, flow-rate, …) and administration protocol (start time, flow-rate, ….) . Total dead volume information will also need to be calculated by the iPRECIO^® Management software.

Total dead volume consists of the fundamental dead volume of the iPRECIO^® pump and the dead volume of the catheter. Catheter dead volume will include the total remaining length of iPRECIO^® catheter and any additional attached catheters. User will need to input this accurately to obtain the accurate results.

Flow Rate Mode

1. Constant Flow Rate:

Configure one constant flow rate for infusion

*The software automatically shows the maximum duration based on the Dose/Flow Rate, Battery Life, Animal Body Weight.

2. Variable Flow Rate:

This window is also used for Repeat Mode Setting.

(1) 3 groups shown.
(2) Set number of times to repeat each group.

Repeat Mode:

Repeat Mode allows the 10 flow steps to be used in a more sophisticated Infusion protocol where up to 2500* steps may be programmed. Therefore infusing protocols taking into account circadian rhythm, oral drug intake (3-4 times per day) or studies for dose response curves may be programmed.
* 10 steps x 250 times repeated (subject to battery life)

Combination of the Infusion Mode & Flow Rate Mode

User can select each combination between the infusion mode and flow rate mode.

Management Software < 4 steps >

	Input General Information of the study Study Name, Number/ ID, Date, Animal Species, Strain, Age, Compound Name/ID, Concentration, Buffer Name, Administration Route, Number of Groups and Animals, etc.
	Animal Groups Settings # User inputs the concentration of solution and estimated maximum/minimum body weight expected of a subjected animal at the end of the study. Then the software automatically calculate the maximum/minimum dose which can be administered during the experiments. # User selects either “Infusion Mode” or “Flow Rate Mode” and inputs the dose or flow rate of solution which will be administered. ** User can select the software types of “20 Groups x 20 Animals” or “50 Groups x 50 Animals”.
	Advanced Settings of the Infusion/Flow Rate Modes User program infusion protocol as infusion mode and flow rate mode for each animal/pump. Also user input Animal ID, Body Weight, Sex at this step.
	Download of the Protocol Settings to the each Pump Check the infusion protocol and schedule set for each animal/pump and download its protocol into the memory installed inside of the pump.

You can confirm the administration schedule and the remaining volume of the pump reservoir, refill date, record the factual refill date, upload the log data of the pump.

Data Communication (IR)

IR communications are used for loading the infusion program and activating the pump. It is made directly without removal from the blister pack. Therefore sterility is maintained until the pump is taken to the sterile surgical suite for filling/activation and implantation.

Unique S/N ID with factory calibration data

Each pump’s unique ID and calibration factor is read from each pump during the programming phase.

GLP Compliance

For GLP compliance, accuracy of flow infusion can be validated.
In addition, the iPRECIO can be user calibrated.

User log-in and password control options are available to the study director to restrict access to iPRECIO Management Software.

Long Battery Life

The battery life is up to 6 months at a flow rate of 1.0μL/hr continuously.
You can confirm the estimated battery life on the PC Screen when you set the infusion protocol with the iPRECIO Management Software.

Research Applications

Tabular highlights gives a high level view of how iPRECIO implantable micro infusion pumps were used/programmed in selected scientific publications