ORONO, Maine — A Maine medical device manufacturer has been awarded a patent for an invention that will provide doctors with the ability to detect patients at risk of diabetic limb loss more reliably and at earlier stages. O’Brien Medical, LLC, today announced that it has been granted patent #8,684,945 by the U.S. Patent and Trademark Office for its Electronic Tuning Fork, or ETF128. The device offers a significant improvement over current methods used by doctors for detecting diabetic peripheral neuropathy, which is a common precursor to diabetic limb loss.
“The ETF128 provides the medical profession with a notably improved method for diagnosing the degree of peripheral neuropathy in diabetic patients. With earlier detection and quantifiable testing results, this device will enable doctors to more rapidly implement preventive strategies that can reduce the occurrence of foot ulcers, infections and amputations,” said Dr. Todd O’Brien, president and founder of O’Brien Medical, in a company press release.
Neuropathy is a disorder of the peripheral nervous system that can cause pain, loss of sensation, weakness and paralysis of limbs. It is a common symptom of diabetes and often starts in the longest nerves in the body, namely those nerves at the tips of the toes.
For decades medical professions have used the traditional hand-held tuning fork along with other sensation tests to diagnose the onset of neuropathy in diabetic patients. While the tuning fork has proved to be a sensitive indicator of neuropathy, it has limitations in terms reproducibility and quantification of results. The ETF overcomes these shortcomings by transforming the tuning fork into a modern digital instrument calibrated to provide standardized, quantifiable results. The improved accuracy and reproducibility afforded by this approach gives physicians a reliable method of detecting and measuring peripheral neuropathy.
“One of the major downfalls of traditional tuning fork testing is variation in use between doctors. This fact, combined with a lack of standardization between tuning fork manufacturers results in imprecise results. The ETF is designed to overcome these limitations and provide doctors with a superior state-of-the-art diagnostic tool,” O’Brien stated.
Field testing of ETF beta prototypes began in July 2013 at academic medical centers, clinics and private practices across North America. These locations were chosen for their excellent reputations, resident specialists and high volumes of diabetic foot patients. Physicians testing the device generated strong positive feedback and provided insights on how to improve the design prior to commercial launch. A proof-of-concept study, published in the March 2014 edition of theJournal of the American Podiatric Medical Association, the world’s leading peer-reviewed podiatric publication, offers further evidence for the effectiveness of the ETF.
The development of the ETF began more than five years ago when O’Brien, a practicing doctor of podiatric medicine with a 20-year history of medical device invention and development, conceived of the idea. O’Brien first approached the Advanced Manufacturing Center at the University of Maine to develop a proof-of-concept ETF.
“The Electronic Tuning Fork is a great example of the kind of medical device R&D that’s occurring now in Maine,” said John Belding, director of the Advanced Manufacturing Center, in a press release. “It turned out to be a very successful collaborative project for the AMC and University of Maine, and we’re pleased that O’Brien Medical has been awarded a patent for the instrument.”
O’Brien’s next step was to develop the beta and commercial versions of the device. This was accomplished through the combined efforts of Dr. Bruce Segee of UMaine’s Department of Electrical and Computer Engineering and Stephen Abbadessa, a mechanical engineer from the private sector. Segee, an enthusiastic supporter of UMaine’s role in local entrepreneurship, views the project as an illustration of how the University can help grow the Maine economy.
“This is the perfect example of how things should work” said Segee. “We have a physician who has been trained to diagnose neuropathy the same way that previous generations of doctors have done it, who says “I can improve on this”. With entrepreneurial assistance, seed capital, local expertise and assistance from the University of Maine, he’s started a company, field tested working units, and is well on his way to a major launch of a product that can literally make the world a better place.”
The National Institutes of Health reports that nearly 26 million Americans – 8.3 percent of the population – have diabetes. Of these, 7 million do not know that they have the disease. Diabetes is the seventh leading cause of death in the United States. The lack of early detection and awareness leads to a large number of preventable complications, including limb loss and premature death.
“More than half of diabetic patients develop neuropathy and a significant number suffer severe and permanent limb impairment,” O’Brien stated. “With earlier detection of neuropathy, physicians will be able to implement preventive strategies that can reduce the occurrence of ulcers and other consequences of neuropathy, thereby improving the quality of life of diabetic patients.”
The patent issued on the ETF further strengthens O’Brien Medical’s position as it ramps up for its pilot production run. A Maine electronics manufacturer has been selected to produce the device. O’Brien expects the device to be available for purchase in late 2014.
O’Brien Medical, LLC, was founded by Todd O’Brien, DPM in 1999. Dr. O’Brien’s 20-plus years as a surgeon/inventor serves as the foundation for his medical product designs. The company’s products are currently marketed in North America and Europe.