Peripheral Artery Disease (P.A.D), a serious condition affects 8 to 12 million people in the U.S and millions more worldwide. The condition results when clogged arteries reduce blood flow to the limbs. However, the condition is rarely on the radar of many Americans.
P.A.D can cause painful cramping or leg numbness and in its most severe form can result in gangrene, leg amputation, and sometimes death. With the right monitoring tools, the disease can be halted or even reversed.
So far, clinicians have lacked a quick and reliable way to monitor P.A.D. However, a device has been developed with funding provided by the National Heart, Lung, and Blood Institute (NHLBI) https://www.nihibi.nih.gov through the Institute’s “Small business Innovation Research” (SBIR) program.
The SBIR program requires eligible governmental agencies to set aside a percentage of their extramural budget to help small businesses to engage in R&D that has a strong potential for technology commercialization.
The biosensor referred to as “The Lumee ™ Oxygen Platform” is an injectable biosensor that can remotely measure tissue oxygen levels in people with P.A.D. The device was developed by Profusa, Inc. https://www.profusa.com a California based company.
P.A.D. is currently diagnosed using a method called the ankle brachial index that compares blood pressure in the ankle to blood pressure in the arm to provide information on how blood is flowing through the limbs.
However, it can’t show which blood vessels are narrowed or blocked, and it can’t directly measure oxygen flow through the surrounding tissues. But the Lumee system is able to provide the measurements.
Doctors place a sensor under the skin of the leg or foot, using a special injection device. A surface reader then shines near–infrared light into the skin to activate the sensor. The reader detects the amount of fluorescence emitted from the sensor, and that information is sent through a cable to a special laptop computer that graphically translates and displays the amount of oxygen present.
Researchers are developing two types of easy to use readers. One is a disk shaped device similar to a smart watch as well as a thin patch like reader which is called a smart bandage. Both types are designed to be applied to the skin and are equipped to wirelessly send signals to a cell phone, opening the door to at home monitoring of P.A.D in the future.
The oxygen sensing system has been available for almost two years in Europe and has been used with promising results. However, in the U.S. the device is still investigational and still undergoing clinical testing with no serious side effects reported as of this date. The company plans to submit the device for FDA approval within the next year.
For more information on the NHLBI SBIR program go to http://www.nhlbi.nih.gov/sbir or email Jennifer C. Shieh, PHD, NHLBI Small Business Coordinator & Program Director at nhlbi_sbir@mail.nih.gov.