Re-re-reflection Peak (#5)

Re-reflection Peak (#4)

Renal Reflection Peak (#2)

Iliac Reflection Peak (#3)

115 ms

0.2 Seconds

121 ms193 ms

172 ms

168 ms

Primary Systolic Peak (#1)

CareTaker™

CareTaker is a new Monitoring Device for the Detection and Warning of Nocturnal Hypoglycemia, Nocturnal Dip, Sleep Disorders, and Adherence and Efficacy of Treatments.

CareTaker is a comfortable physiological monitor that can be worn all night without disturbing sleep. It tracks blood pressure beat by beat, heart rate, heart rate variability, breathing rate, blood pressure variability, hand temperature, and other parameters. The device is

the size of a bar of soap, fits in the palm of the hand, and records physiological parameters for ten hours.

Bluetooth enabled, CareTaker has an embedded ARM processor that can diagnose dangerous trends in physiological parameters, specifically nocturnal hypoglycemia, and, if enabled, call for alarms when appropriate. CareTaker can communicate with cell phones, computers, and PDAs.

CareTaker can detect dehydration and was recently used to detect and approximately locate six aortic aneurisms that were later surgically repaired. After repair, CareTaker did not detect any of the aneurisms. All this and more is coming from just a finger cuff. The amazing abilities of CareTaker are due to a completely new way of detecting and analyzing the pulse pressure wave form. CareTaker works by detecting the arterial pulse at the finger using a comfortable, low pressure cuff. First the pressure wave form is detected at the finger. The pulse is known to consist of five individual pulses that superpose to produce the wave form. The first pulse is the ejection pulse from the heart. The next is a reflection or echo from the region of the aorta where the renal arteries leave. The third pulse is a reflection from where the iliac arteries bifurcate. The fourth and fifth pulses are interesting, but not presently used in any calculations. By using the amplitudes and arrival times relative to the primary pulse, CareTaker detects many physiological parameters in real time for a long time.

In its present form, CareTaker is the result of over a million dollars invested by the Office of Naval Research for a simple device to monitor battlefield casualties. CareTaker was

Arterial Pulse as detected by CareTaker

shown to detect hemorrhaging, a major cause of death if untreated. Further funding has been received from the National Heart Lung and Blood Institute of NIH. Current funding is provided from the Office of the Secretary of Defense through ONR. Prototypes were constructed through funding from OTTC/CCAT, California State University at San Bernardino. Current prototypes have been sold to several countries and organizations in the US. Empirical is presently engaged in a clinical trial at the University of Virginia, which will establish, for FDA purposes, that CareTaker accurately tracks central blood pressure beat by beat. Other tests are ongoing at the University of Texas Medical Branch, Mayo Clinic, Winona University, University of British Columbia, University of Texas Veteran’s Hospital in San Antonio, and California Institute of Technology. However, no tests or interest has been associated with the protection of diabetics.

CareTaker can help people with diabetes because most type I and many type II diabetics suffer from nocturnal hypoglycemia and CareTaker can detect physiological changes well before the hypoglycemia becomes dangerous. Children often have no activation of the sympathetic nervous system during nocturnal hypoglycemia meaning that they don’t

wake up. In type I adults, warning signs such as headaches, weakness, fatigue, confusion, amnesia, blurred vision, focal neurological deficits, seizures, and coma are attenuated to the point where patients become unaware. Nocturnal hypoglycemia decreases declarative memory in type I patients. After nocturnal hypoglycemia, there is often a deterioration of mood, an increase in hypoglycemia associated autonomic failure leading to increased risk of severe and prolonged hypoglycemia, and an increase in the QT interval leading to polymorphic ventricular

tachycardia that can degenerate to fatal arrhythmias such as ventricular fibrillation. These are only the direct problems of nocturnal hypoglycemia. Diabetics are known to be at higher risk for heart and kidney disease. Poor sleep or absence of a nocturnal dip in blood pressure is known to aggravate or cause hypertension, kidney failure, and obesity. Yet, there are no physiological monitoring devices that can measure blood pressure without waking the patient. It is perhaps an understatement to say that the largest unsolved problem of diabetics is sleep management and monitoring. It is also an understatement to say that the final frontier of health may well be the understanding and management of sleep in general.

Beyond simple detection and warning of nocturnal hypoglycemia, CareTaker can manage blood pressure during the day. Because diabetics are at increased risk due to

CareTaker is small, light, and Bluetooth enabled. It works from a low pressure finger cuff that can be worn all night. A newer design will fit inside the palm.

hypertension, frequent measurements are vital to its management. Anyone who is at risk for nocturnal hypoglycemia should have a CareTaker especially those who sleep alone.

About Empirical Technologies Corporation

Empirical Technologies Corporation (ETC) is privately held Virginia Corporation founded in 1995 for the purpose of developing new tools for monitoring of blood pressure and the early detection of hemorrhaging. Beginning primarily as a research lab, the company has developed a break through product, CareTaker, a multi-parameter physiological monitor that allows for heartbeat by heartbeat monitoring of blood pressure, heart rate and respiration rate, with trending and variability analysis. The data produced can be stored, transmitted to other medical equipment or telemetered to remote physicians for diagnostic or first responder support.

CareTaker technology has been clinically verified to be an accurate non-invasive beat by beat vital signs monitor in a variety of tests conducted under approved protocols. The CareTaker System requires no electrodes or wires and is Bluetooth enabled. It provides real time information on physiological changes including occult hemorrhaging and the rate of hemorrhaging.

CareTaker represents a major improvement in vital sign monitoring in that it most directly represents the real time state of a patient. It is non-invasive and the finger cuff required is much more comfortable than similar products. The company believes that it will become the gold standard in monitoring equipment with potential buyers including trauma and ambulance services for field monitoring, hospitals for ward and post-procedure work, clinics, physician groups and private practitioners. The noninvasive CareTaker could replace 70% to 90% of arterial catheters used during surgery or for hemodynamic monitoring.

For more information contact:

David W. Gerdt, Ph.D.PresidentEmpirical Technologies CorporationPhone: 434-296-7000davidetc@firstva.com

The Palm Sized CareTaker for Sleep Applications (now available in prototype form).