It is often necessary or desirable to infuse a flowable material or fluid, which may be liquid, a gas or a combination thereof, into a patient. One example is the administration of parenteral fluids to a patient.
A typical infusion system includes an infusion device for delivering the fluid and conduit means for conducting the flowing material from the infusion device to the patient. The conduit means typically comprises flexible tubing leading from the infusion device and a cannula, such as a needle or catheter, for insertion into the vascular system of the patient. In normal operation, the infusion device delivers the fluid through the tubing and the needle to the vascular system of the patient.
One problem with infusion systems of this type is a condition known as infiltration. Infiltration is a condition in which infused fluid finds its way into extravascular tissues rather than simply being released into the blood stream. Such a situation occurs when the needle is not in communication with the interior of the vessel into which the fluid is to be infused. When this occurs, fluid is infused into the interstitial spaces between layers of tissues. Thus, the patient is deprived of proper intravenous drug administration and is further subjected to possible toxic or caustic effects associated with infused fluids being in direct contact with body tissues. Infiltration is not the only possible type of anomaly associated with intravenous therapy which can cause the fluid to be improperly supplied to the patient. Other conditions which can cause abnormal infusion, i.e., the fluid to be improperly supplied to the patient, include venous inflamation and swelling at the infusion site (phlebitis), clotting and a wide variety of obstructions of the conduit means, such as kinking of the tubing which supplies the fluid to the patient. Many of these affect fluid flow characteristics in a manner similar to infiltration and can, therefore, be detected by infiltration detection devices.
The goal of an infiltration detection system is to identify an abnormal infusion as early as possible without generating an excessive number of false alarms. Early detection allows the attending medical staff to rectify the problem before significant damage has been done by the infiltration and before the patient has been deprived of a significant amount of the intravenous therapy. On the other hand, if the detection system is too sensitive, false alarms will result. This is very undesirable since, from a clinical perspective, establishing a new intravenous site can be difficult and time consuming. During the time necessary to start the new IV, which can be hours in some cases, the patient is not receiving the desired treatment.
Bobo U.S. Pat. No. 4,648,869 discloses a significant advance in the field of infiltration detection systems and methods. According to the Bobo patent, an infusion system infuses a test pulse of fluid to a patient. The test pulse creates a pressure wave response which can be monitored and used to detect if abnormal infusion has occurred.
Butterfield U.S. Pat. No. 4,710,163 discloses an infiltration detection system which uses the test pulse-pressure wave response concept of the Bobo patent. However, the Butterfield system compares the pressure wave response with a reference pressure wave response which represents the normal response when there is no infiltration. Specifically, the area between two curves representing these responses is used to attempt to detect infiltration. Thus, the Butterfield approach has the disadvantage of requiring that a normal pressure wave response be first determined and then stored for later comparison.