Isys Medical Technology

It has been recently projected that one in every three children born in the United States will develop diabetes during their lifetime. Diabetes is a disabling disease primarily because it leads to disease of the blood vessels in a variety of organs including the heart, retina, kidney and nerves. It is vital that complications of diabetes be diagnosed early and treated appropriately in order to minimize human suffering and costs incurred from the disease. Involvement of nerves, referred to as neuropathy, is often the earliest manifestation of diabetic complication. About one third of diabetics that have normal urinary excretion of albumin and therefore normal kidneys, already have neuropathy. In its early stages, neuropathy is a silent disease, and when advanced is often painful and disabling. Diabetic neuropathy is best detected as an impairment of vibration sensation by the examining physician. Other common conditions associated with neuropathy are kidney failure, alcoholism, vitamin deficiencies, and carpal tunnel syndrome.

Perception of vibration is tested using a tuning fork that is applied to a bony prominence on patients’ hand, ankle or foot. A patient suffering from neuropathy would stop feeling the sensation while the examining physician can still feel it vibrating. Even though considered the standard method to test vibration sensation, physicians seldom perform the test because tuning forks are cumbersome, difficult to carry around and most physicians are not used to carrying gadgets other than a stethoscope and a pager or a cell phone. Furthermore, testing vibration by a tuning fork is non-quantitative, inaccurate and operator-dependent. More sophisticated devices for testing vibration are available, but have been beset with drawbacks, such as being heavy and cumbersome, inconvenient and expensive - they are being used as research tools but have not yet made it to widespread usage in the primary care setting. In fact, a majority of physicians, including the inventor of this invention have never seen these devices, let alone use it.

In view of the drawbacks associated with conventional tools and techniques, there is a need for a better and improved clinical tool for the detection of neuropathy that is portable, can be easily carried by a physician or other health care professional on their person, and is more sensitive and specific compared to the tuning fork. Isys Medical’s technology accomplishes this objective by modifying the commonly available vibratory mode in pagers, cell phones (and later a plethora of synergistic devices) such that it can be used to detect neuropathy in a quantitative manner. This modification of existing pagers and cell phones, in view of its dual functionality, is easy and inexpensive to manufacture, and is further easy to carry by health care professionals who routinely carry beepers/pagers or cellular phones. The vibrating device itself, or a probe extending from the device, is applied to the patient's extremity (finger, toe, tibia, wrist, face, etc.) and vibrates at a magnitude (or amplitude) and/or frequency which determines a specific level or threshold for the patient's ability to detect vibration. The magnitude can be selected to be low (for minimal detection of threshold impairment), medium (to detect moderate neuropathy) or high (to detect severe neuropathy). If the patient can feel the vibration, set at a pre-selected level, the patient's threshold is lower than the level set.

Conversely, if the patient cannot feel the vibration, the patient's threshold is higher than the level set. Quantitative measure of vibration threshold allows monitoring the progression of neuropathy over time. The apparatus is further provided with a display to indicate the selected magnitude and/or frequency of the vibration and may include a suitable memory chip and a microprocessor, or the like components for storing and/or processing the data. This would be particularly useful in monitoring the progress of treatment for neuropathy over time and/or to perform serial evaluation. In addition, this would assist a person in detecting (or monitoring) neuropathy for self-diagnostic or self-evaluation purposes.

Although vibratory testing devices have been available for some time, the present invention represents the first time that a medical device has been proposed that tests for vibration utilizing an electronic communication and medical diagnostic apparatus. The usefulness of the invention is apparent considering that billions of dollars are spent each year on diabetic foot problems related to diabetic neuropathy. However, if this simple, inexpensive device were available to nurses, physicians, and other health care professionals, neuropathy could be detected early and many ulcers, infections, and amputations might be avoided by instituting proper foot care early. In addition, once detected, the treatment of neuropathy could be easily monitored by using this invention.