Problem / Product Overview
It is estimated that over 80% of hospitalized patients receive Intravenous (IV) Therapy. A major problem associated with this therapy is called IV infiltration which occurs when an IV catheter either backs out of the vein or causes damage to the vein wall. This allows IV fluids or medications to soak into the tissues surrounding the IV site. The longer the infiltration remains undiscovered, the more severe the problem. For this reason, diligent assessment of IV sites is essential. Severity of the resulting infiltration can range from redness and minor tissue damage to burns, blistering, nerve injury, scarring and amputation. (See pictorial views of IV sites) Associated treatment increases hospital costs and inpatient time. In addition to patient harm, infiltration is costly to hospitals in terms of lawsuits and reconstructive surgeries. It is one of the more frequent allegations of malpractice and has resulted in multi-million dollar awards.

Added Complications Caused by Infusion Pump Technology
Most infused medications require levels of accuracy that cannot be achieved via a gravity feed. Consequently, they are regulated by using microprocessor controlled infusion pumps. Pumps exacerbate the problem because they produce pressure which drives the harmful solution deeper into the tissues around the IV site.

Existing Infiltration Detection Products
Attempts to provide early detection have used a variety of technologies including ultrasound, microwave, transducers, and impedance measurement. Most have not been well received due to costs or complexity. Additionally, nurses tend to mistrust them because when devices detect an early infiltration none of the typical manifestations (skin blanching, edema, and coolness to touch) are visibly or palpably obvious. Consequently, nurses tend to assume that devices have generated false alarms.

Description of Proposed Detection Device
The device consists of a large clear rectangular bandage which would be placed over the IV site. A segment of the bandage would be coated with thermochromic crystals that would display a real time thermograph of the IV site. Because the IV solution entering the vein is either cooled or at ambient temperature, any infiltrated flow would be easily visible thermographically. It has the following beneficial characteristics: simplicity of use, minimal user training, and ability to visually validate the infiltration without removing the bandage. It is also disposable, inexpensive to manufacture and requires no special hook up, wires, batteries and etc. Since all IVs are held in place by some type of bandage there would be no additional impact in terms of patient care.

The drawings show a representative view of the design with a hypothetical Thermographic view of a normal IV and a hypothetical view of an infiltrated IV.