Pulse oximetry has gained widespread clinical acceptance as a standard patient vital sign measurement because it can give clinicians an early warning of low arterial blood oxygen saturation levels, or hypoxemia. Conventional pulse oximetry is subject to technological limitations that reduce its effectiveness and the quality of patient care. To mitigate the limitations of current technologies, the U.S. Department of Veterans Affairs (VA) has developed a novel device that provides reliable pulse oximetry measurements of oxygen saturation and heart rate in patients with low body temperature due to vasoconstriction and low blood perfusion.
With conventional pulse oximetry, arterial blood signal recognition can be distorted by motion artifact, or patient movement, and low perfusion, or low arterial blood flow. Low perfusion can also cause conventional pulse oximeters to report inaccurate measurements, or in some cases, no measurement at all. The inability of obtaining accurate oxygen saturation measurements can lead to misdiagnosis, incorrect treatment, and the increase of patient risk during medical procedures.
The device consists of a pulse oximeter probe integrated into a bandage- like harness and contains a chemical energy heating source. The device is adapted to reversibly secure the heating source and the pulse oximeter probe to the body region at which the pulse oximeter measurement will be made. The pulse oximeter probe may be configured for transmission mode, reflectance mode, or for both modes. The chemical energy source is a mixture that includes a metal powder that generates heat energy at a predetermined rate via oxidation when exposed to atmospheric air. The pulse oximeter probe could either be designed as a single use probe or reusable upon replacement of the chemical energy-heating source.
Pulse oximetry has emerged as an established standard for measuring vital signs. As a result, the global market for pulse oximeters is expected to increase to $575 million by 2015 with an estimated annual growth rate of six to eight percent. Growth in the pulse oximetry market is driven by ongoing adoption of low perfusion, motion-tolerant technology; rising patient acuity, or severity of illnesses, which increases the need for patient monitoring; and greater efficiencies for the health care worker through increased reliability, improved detection algorithms, and the ability to reject false alarms.
The Department of Veterans Affairs is looking for a partner to further develop and commercialize this technology through a license and the VA inventors are available to collaborate with interested companies through a Cooperative Research and Development Agreement (CRADA). Reference project number 11-099.