Data processing: measuring – calibrating – or testing – Measurement system in a specific environment – Biological or biochemical
Reexamination Certificate
2001-08-28
2004-02-10
Barlow, John (Department: 2863)
Data processing: measuring, calibrating, or testing
Measurement system in a specific environment
Biological or biochemical
C600S300000, C600S316000, C600S365000, C604S067000, C702S023000
Reexamination Certificate
active
06691043
ABSTRACT:
BACKGROUND OF THE INVENTION
For human beings, normal amounts of glucose concentration in the bloodstream are considered between 70 and 126 mg/dl—higher concentration of glucose are prone to cause clogged arteries, urinary infections, retina and kidney damage, etc. Diabetes is a chronic disease related with high amounts of glucose in the bloodstream. American Diabetes Association research shows that there are 135 million diabetic people in the world, and 10% have type-I diabetes (13.5 million people). In the USA nearly 16 million people have diabetes, as follows:
2 million people have type-1 diabetes (1 million diagnosed and 1 million undiagnosed).
14 million people have type-2 diabetes (7 million diagnosed and 7 million undiagnosed),
Every day 2,000 cases of diabetes are diagnosed. Per year, $92 billion dollars are spent by the US government on diabetes—$47 billion dollars only for diabetes-related health problems, such as heart and kidney diseases, amputations, blindness, etc. Diabetes is the US sixth leading cause of death. Tight control of blood sugar level reduces complications by 75%. Currently the most advanced treatment for diabetes is the Insulin Pump, however, most users do not have a practical way to determine the correct amount of insulin that should be injected by the pump.
The insulin pump mimics the human pancreas by constantly injecting, in a paced way, small amounts of insulin throughout the day through a plastic tube inserted in the user's abdomen. This paced activity is called basal rate and its intention is to supply the necessary amount of insulin to the human body cells in order to burn glucose, which keeps the whole organism working. When food is ingested, a larger amount of insulin (bolus) is required for the glucose digestion inside the cells—insulin allows glucose to go inside the cells to be digested. This activity is how energy is produced in the body. The main point of this invention is to disclose an innovative way to determine the right amount of insulin for a bolus. This invention requires an insulin user to determine his/her basal rate. The basal rate is not determined by this invention. The user is required to add the total amount of insulin used for his/her basal rate with the total used for his/her bolus, throughout the day, to use the invention. In 2001, the Insulin Pump market is 125,000 units in the US; 100,000 units in Europe; and 250,000 units worldwide. Type-2 diabetes could also be treated with a pump in the near future, which could make the potential market for this invention increase seven (7) times. This invention provides a way to calculate the correct amount of insulin needed by someone who is a diabetic and/or insulin/insulin-pump user.
BRIEF SUMMARY OF THE INVENTION
Function of this invention performed by the prior work: not applicable. The users did not have a practical way to determine their bolus with exactness, as well as they did not have a practical way to set up carbohydrate ratio profiles on a monthly, weekly or even a daily basis.
Disadvantages of the prior work:
Unstable blood sugar. A small amount of insulin, such as 1/10 of an unit, is very important, and manual calculations do not provide the required exactness such as decimal precision in a day-by-day calculation. A person's carbohydrate absorption changes throughout the day, and the daily pattern can change weekly, or monthly, but for simplicity physicians assume it constant throughout the day and long periods.
Complexity. People who are unable to focus and/or perform complex calculations (such as older and younger people) guess, instead of determine the correct amount of insulin (bolus).
Advantages of this invention over the prior work:
Easy to use. The user is required to enter three data (the blood sugar test reading, the amount of carbohydrates eaten and the amount of insulin he/she forecasts for that day) in order to know the precise amount of insulin required for that meal. If the user's pump can distribute 1/100 of an unit of insulin, the invention can be set up for that precision, as shown by
FIG. 9
, box
169
—whenever a value is shown at the screen or whatever method, the precision of the output can be set at box
169
. For example, if the invention is programmed in BASIC, the user must change the number of units of the character # used with instruction PRINTUSING, in order to set up how the result (bolus) will be displayed. The number of units of the character # determines how many units will be shown: one character # before the period mean up to 9 units of insulin displayed; two characters # mean up to 99 units of insulin displayed; one character # after the period mean up to 9 tenths of unit of insulin displayed (0.9 units); two characters # after the period mean up to 0.9 tenths of units of insulin displayed (0.09) units.
Practical Results. People who are unable to focus and/or perform complex calculations (such as older and younger people), will not need to go through manual calculations to determine the correct amount of insulin required for a meal. The invention calculates the precise amount of insulin needed by someone who is diabetic and/or insulin/insulin-pump user and provides a practical method to make the necessary changes (weekly, monthly, every other month, etc) in the personal carbohydrate ratio profile.
REFERENCES:
patent: 5019974 (1991-05-01), Beckers
patent: 5822715 (1998-10-01), Worthington et al.
patent: 5997475 (1999-12-01), Bortz
patent: 6269314 (2001-07-01), Iitawaki et al.
patent: 6425863 (2002-07-01), Werner et al.
Mann et al., “External infusion device with remote programming, bolus estimator and/or vibration alrm capabilities”, Pub. No.: US2002/0107476, Pub. Date: Aug. 8, 2002.*
Robinton, “How to measure Blood Sugar to Insulin ratio”, v1.04, Feb. 6, 1998. Retrieved from Internet electronic mail:<Michael@bzs.org>.*
Pecoraro, “Carbohydrate Counting and Insulin Ajustment”, Novo Nordisk Pharmaceuticals, Inc., Jul. 2001.*
Nowizky, “Insulin Bolus Calculation Form”, Aug. 10, 1997, NowizKonsult Co.
Barlow John
Le John
Maxi-Med, LLC
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