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SASH

Automated ambulatory care infusion pump

The present situation:

The common practice today:

It is now common for intravenous medications such as antibiotics, antiviral, antiemetics, chemotherapy and biotechnology drugs to be administered intermittently with a frequency as often as multiple times per day. Depending on the frequency of administration, the patient is either repeatedly connected to and disconnected from an intravenous (I.V.) line or is continuously connected to an I.V. line between administrations.

In either case, the intermittent medications are generally administered by trained personnel using predefined procedures that often include a series of manual steps and a large number of disposable supplies. Each manual step in these procedures increases the risks associated with multiple manipulations and entry of I.V. sites.

The predefined procedures attempt to ensure the proper administration and the proper dosing of medication, while preventing incompatibilities between different drugs and preventing I.V. lines from clotting off between doses.

The problems of the existing practice:

Unfortunately, because of the manual steps included in these procedures, they have not been entirely successful in guaranteeing that medications are administered in the correct sequence, at the correct infusion rates, and in the correct volumes. Further, if the appropriate procedural steps are not performed within the required time frames, clots may form in the I.V. lines. Also, the manual steps included in these administration procedures are the principle source of infection and other complications that may arise during intermittent infusion therapy.

Such problems and complications result in a longer hospital stay for the affected patient. Recent trends which have the patient trained to administer their own medications at home only exacerbate the problems and risks associated with intermittent infusion therapy. Further, elaborate or complicated infusion procedures are more likely to give rise to patient non-compliance by an untrained and less sophisticated home infusion patient.

A clinical example:

One prevalent example of home health care therapy is the delivery of antibiotics and other medications utilizing the SASH protocol. SASH is an acronym that stands for Saline-Antibiotic-Saline-Heparin. The patient is trained to follow the SASH protocol by first attaching a saline filled syringe to the catheter to flush and clear the line. The patient then attaches a second syringe filled with the desired medicine or the patient attaches an IV set connected to a mini bag, or other container, to the catheter and the medicine is delivered to the patient. A third syringe filled with saline is then attached to the catheter and the saline is injected to clear the line of all medication. Finally, a last syringe is attached to the catheter line and a heparinized solution is injected into the line to keep the line open and maintain the patency of the line for the next time a medication needs to be delivered.

The SASH system is currently delivered to the patient in two ways. In the first way the patient is given syringes, needles and vials of saline, medication, and heparin and the patient is instructed how to use the tools. In the second way, pre-filled syringes are supplied to the patient and instruction is provided.

The normal SASH procedure is to clear the line with a small injection of saline, administer the desired medication, clear the line again with another small injection of saline and then to inject heparin in the line to maintain patency of the IV site. The final injection of heparin into the IV site prevents coagulation in the line until the next administration of medication. Each of the fluids in the sequence is injected with a separate syringe with the only possible exception being the medication which may be delivered through an IV set.

Some medications require a relatively long period of time to inject because they will cause vein irritation or other complications if they are injected too quickly. To avoid this, the medication is diluted into a volume of solution, typically normal saline or DSW, up to 250 cc's. The infusion time can take in excess of 60 minutes.

The above procedures involve the use of multiple syringes and needles, vials of saline and heparin and an IV drip set for medications that must be administered over a relatively long period of time. In this instance, the patient is connected to an IV drip after the initial line clearing injection of saline. When the IV drip is finished, the line is again cleared with saline from a syringe and the heparin is injected to maintain the potency of the line. The patient, nurse or pharmacist must fill the syringes from the vials for each of the injections and the needles used in the procedure must then be disposed of in a safe manner.

In common practice is the use of low cost disposable infusion pumps that administer the antibiotics without tying the patient to the bed.  These pumps enable the administration of the drug in the patient's home or other non-hospital sites. The problem limiting this practice is the need to go through the SASH procedure requiring valuable medical personnel time.

Up until now, there is only one automated SHASH infusion pump in the market. The device made by Tandem Medical can administer the SASH protocol automatically. The major drawback of the system is the fact that it has a complex, expensive single use bag and a multi-use non disposable $800 hardware. This complicates the ability of alternate care sites use. In 2001 the company got a 13 million $US investment.

 

Automated ambulatory care infusion pump:

Therefore it would be of great advantage to have a delivery system for multiple medications that does not involve the use of multiple syringes and needles. It would also be an advantage to have a medication delivery system that could be pre-filled with the correct volume of medication or multiple separate medications and which could be administered by the patient automatically in the correct sequence and/or concurrently over the desired time period. A desirable medication delivery system would be extremely simple to use, low in cost and could then be discarded without the usual concerns over the disposal of medical waste.
Accordingly, there exists a definite need for simplifying the administration of intermittent medical infusion therapy.

The proposed system has several advantages:

  • It is custom designed for the market requirement for low cost, easy service Alternate site therapy IV infusion pump, in order to meet the needs of patients treated in the community.

  • The worldwide market, for the device is constantly increasing due to the shift in transporting various types of treatments to alternate care sites in order to decrease expenses and free hospital beds. The estimated market size is more than 1billion US$ a year.

  • The system is based on a technological basis of collapsible cells that are divided by pressure sensitive valves, allowing the safe injection of one drug after the other.

  • The system has the further advantages of low cost, standard infusion procedure that requires no external pressure or elevated position, intended to replace various types of IV pumps.

  • The system is completely disposable. There are no multi-use components.

Summary:

The system is intended for the intravenous infusion of medication and, more particularly, to the automatic administration of intermittent medications in accordance with a predetermined medical therapy. An infusion pump is manufactured with an ability to contain several collapsible chambers pre filled with medicaments and intravenous fluids, intended for implementing a prescribed infusion therapy. This type of device simplifies the administration of a complex medical infusion therapy.