ivWatch, a medical device manufacturer focused on improving the safety and effectiveness of intravenous therapy (often referred to as an "IV") through early detection of infiltrations, today announced that the U.S. Patent and Trademark Office has issued to ivWatch a key patent regarding the use of light to detect if fluids are leaking from an IV.
U.S. Patent No. 9,326,686, titled "System and Method for Mitigating the Effects of Tissue Blood Volume Changes to Aid in Diagnosing Infiltration or Extravasation in Animalia Tissue," includes claims for detecting such leaks while dealing with the physics associated with patient movement.
The technology behind this patent directly relates to the ability of the ivWatch Model 400 to reduce the number of "false" alarms for our product and not contribute to the ongoing issue and syndrome known as "alarm fatigue". This serious issue garnished the attention of the Joint Commission back in June 2013, when alarm safety was set as a national patient goal. A recent WSJ article stated that as many as 90% of alarms are false or don't require any immediate attention. But when clinicians become desensitized to the alarms, they can overlook the 10% of the notifications that are critical, and lead to fatal mistakes. A common cause of false alarms from devices is due to patient movement.
The ivWatch Model 400 includes a noninvasive sensor that uses near-infrared light to detect changes in the optical properties of tissue seen during an infiltration. Changes in the tissue blood volume associated with patient movement affect the signal primarily by changing the amount of hemoglobin, a dominant absorber, in the underlying tissue. The reading from the sensor is analyzed by the highly intuitive pole-mounted patient monitor. The ivWatch technology is able to analyze and detect infiltrations in common IV therapy settings, allowing the patient to move freely while still being continuously monitored. The device will notify clinicians if conditions suggest an infiltration, allowing them to address the issue early to help reduce patient harm.
"This latest patent demonstrates the depth of the science behind the ivWatch technology. You can't expect a patient to remain still while they are receiving care. Our breakthrough technology has allowed the ivWatch Model 400 to accurately detect infiltrations without impacting patient mobility," states Gary P. Warren, CEO of ivWatch. "We expect the hard work and dedication of the inventors of this patent to have a meaningful contribution to the improvement of patient safety. Our product provides a new option for medical professionals – a continuously monitored peripheral IV – that can reduce costs, risk, patient harm and medication dosing errors".
The technology is a core component of the ivWatch Model 400, a FDA cleared device that continuously monitors a patient's peripheral IV for the early detection of infiltrations, when medication or fluid leaks outside the vein into the surrounding tissue. Peripheral IVs are one of the most common invasive medical procedures performed with over 300 million IV catheters sold in the U.S. annually. Yet, current medical reports peg the failure rate of IVs in excess of 20% due to infiltrations which can cause drug delivery errors and patient harm.
The ivWatch announced U.S. commercial availability of the ivWatch Model 400 in April. To learn more, visit www.ivWatch.com.