Surgery – Diagnostic testing
Reexamination Certificate
2001-06-21
2002-12-17
Hindenburg, Max (Department: 2736)
Surgery
Diagnostic testing
C273S459000, C434S235000, C600S365000, C178S038000
Reexamination Certificate
active
06494830
ABSTRACT:
BACKGROUND OF THE INVENTION
Juvenile Diabetes strikes about 15,000 children every year under the age of 20. Currently, the United States has over 200,000 of these children that daily struggle with this disease. Contraction of diabetes requires the afflicted to frequently monitor blood glucose in order to avert long-term damage to their kidneys, eyes, and feet. However, there is no blood glucose testing devices currently available that provide or incorporate any motivation or reward mechanisms to encourage the individual to continue this testing regimen. Because the majority of the diabetic population is adults, most commercially available glucose testing meters are designed in such a fashion that is not user-friendly or socially acceptable to children. This causes children to shy away from blood glucose testing in a social setting. This anti-social aspect could expose them to episodes of hypoglycemia, hyperglycemia, and/or insulin shock.
Abstinence from regular blood glucose testing, for any reason, can have a devastating impact on the long-term wellness of the diabetic adolescent and contribute to significant increases of future health care costs. There have been many articles written and scientific studies conducted about incorporating motivational stimuli into medical testing procedures yet no significant improvements have been made to these devices. Many positive outcomes have been realized and the increased testing compliance has been achieved. (Lieberman, Debra—Health Education Video Games for Children and Adolescents: Theory, Design, and Research Findings)
Researchers in the field of diabetes are exploring technologies and methodologies to perform non-invasive glucose blood-level monitoring in Type I and Type II diabetics. Currently, there are two popular types of technology used in determining blood glucose levels that are found in the majority of home glucose monitoring devices. First, is the reagent type and the second is an enzyme/current differential device. The reagent strip or chemically reactant strip method requires placement of a small blood sample on a chemically treated test strip. A amount of glucose in the blood changes the color of the chemically treated test strip. A differential measurement is then taken from the test strip without a blood sample and compared to the color of the test strip once the blood has been placed on the strip and a finite testing period has been allowed to elapse. The enzyme/current differential method determines proper blood glucose by determining the amount current change that takes place when a glucose blood sample is placed on the test strip. An enzyme coating of the test strip directly affects the electrical resistance of the test strip. With both technologies proper glucose level is determined by comparison of either the color properties or the electrical current change in the test strip.
One of the most difficult challenges in the glucose testing device market has been to develop a glucose-testing device that does not require a small capillary blood sample. The “non-invasive” approach would become a huge commercial success because it would eliminate the element of pain associated with extracting a blood sample and increase the frequency of blood glucose testing.
It is public knowledge that one of the non-invasive approaches that could become commercially available is using a series of EKG/EEG readings, associated with a host of complex algorithms to determine blood glucose levels. It is not believed, however, that there are not any commercially available products incorporating such technologies and/or methodologies, although a commercially viable EKG/EEG glucose-monitoring device may soon become available. It is also believed that due to this research, other new products, incorporating other sensors might become available to detect epileptic seizures and asthma attacks.
SUMMARY OF THE INVENTION
The Invention presents a system and method of combining a medical device, a medical testing procedure, in a combination of hardware and software that provide motivation and digital rewards through a hand held video game controller or other hand held computing device.
In view of the potential commercial availability of these types of devices, the embodiments of the invention miniaturize and consolidate medical diagnostic electronic circuitry with additional software and hardware circuits that provide motivational elements before, during and after the diagnostic testing procedure. Such medical diagnostic electronic circuits are those that perform tests for blood glucose, high blood pressure, lipids, peak and flow, and oxygen saturation. All of the aforementioned circuits would be redesigned into a physical form that allows said medical circuits to be physically inserted into a socially acceptable hand-held microprocessor driven controller, such as a GAMEBOY® or HANDSPRING® Personal Desk Assistant.
After glucose data is converted and proper readings are displayed via the LCD on the invention and/or stored, a user of the device can select from a menu of different commands generated by the motivational hardware/software structure of the invention. Such games would be intended to educate and encourage more frequent participation in testing and maintaining proper glucose levels. The determined medical test results serve as a root motivation for the player to advance within, regress, complete, and/or be eliminated from the game or other form of entertainment provided by the device. The entertainment portion according to an embodiment of the invention may contain multiple games within a single cartridge or adapter module. Provisions are also being made to change games via the Internet. Daily, weekly, monthly, and yearly selection of historical values or other data can be user-defined and implemented through different hardware or software switches in the device. According to another aspect of the invention, the hardware/software stores these glucose values to an EEPROM that can be retrieved at a later date,
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Astorino Michael C
Guidance Interactive Technologies, Inc.
Hindenburg Max
LandOfFree
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