Over one million patients receive some type of infusion each day, and 90% of hospitalized patients receive an intravenous infusion at some point during their hospital stay. In an example of technologic overkill, nearly all inpatient infusions, including routine ones, are delivered by complex and expensive electric pumps instead of simple gravity. An increasing number of patients are also receiving infusions outside of the hospital in ambulatory facilities and in the home. Disposable infusion pumps have many attractive features that favor their use in these settings over outpatient electric pumps, and are used to deliver medications, including antibiotics, local anesthesia, and opioids. Inpatient infusion sets and disposable infusion pumps account for nearly 20% and 10%, respectively, of the estimated $5 billion annual global infusion market.
Infusion pump errors are a serious ongoing problem and represent a large share of the overall human and economic burden of medical errors. Electronic infusion pumps have become expensive and high maintenance devices, which have been plagued in recent years by recalls due to serious software and hardware problems. These pumps are designed for fine adjustments of infusions in complex patients, such as those in a critical care setting, and their use for routine infusions is technologic overkill. In terms of outpatient infusions, disposable infusion pumps can be highly inaccurate and are therefore unsuitable for use with medications where flow accuracy is critical, such as chemotherapeutics. The FDA’s MAUDE database includes numerous reports of complications and even deaths resulting from disposable infusion pump flow inaccuracies.
We are developing highly-accurate infusion systems using variable flow resistors, building on principles underlying two issued patents, which we have acquired. Our variable flow resistors adjusts its resistance to match the input pressure, maintaining a constant predetermined flow rate. The device’s design ensures that it can only flow at the designated flow rate, preventing complications associated with infusions running too slow or too fast. The variable flow resistor device will be incorporated into intravenous infusion sets and disposable infusion pumps for routine inpatient and outpatients infusions respectively. We believe our infusion sets will permit hospitals to return to gravity and eliminate expensive electric infusion pumps for most inpatient infusions. We also believe the accuracy of our device incorporated into disposable infusion pumps will allow outpatient administration of a broader range of drugs, thereby significantly expanding the addressable market.