Implantable sensor and system for measurement and control of blo

Surgery – Diagnostic testing – Measuring or detecting nonradioactive constituent of body...

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600341, 600317, 600322, 6048911, 607 22, A61B 500, A61M 5142

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061225363

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BRIEF SUMMARY
FIELD OF THE INVENTION

The present invention relates to medical devices for sensing the level of a constituent in a body fluid such as blood, including but not limited to blood glucose, oxygen, antibiotics, enzymes, hormones, tumor markers, fatty acids, and amino acid levels. The present invention also relates to a system for control, monitoring and reporting blood constituent levels in response to sensed levels and to provide continuous monitoring and control of blood constituent levels to permit aggressive therapy and concomitant clinical benefit of such therapy.


BACKGROUND OF THE INVENTION

Metabolic processes in living organisms proceed according to an exact administration of chemical compounds that are manufactured and released throughout the organism. These chemical compounds control the function as well as the condition of vital organs, tissues and processes that sustain or exist within the organism. In many instances these chemical compounds can be found in the organisms fluids including blood as in the case of mammals. These chemical compounds in the blood are generically referred to as blood constituents.


Blood Constituents

Glucose
A blood constituent such as Glucose is an important nutrient and indicator for human organisms. During periods of moderate to heavy exercise, the muscles utilize large amounts of glucose to release energy. In addition, large amounts of glucose are taken up by muscle cells in the few hours after a meal. This glucose is stored in the form of muscle glycogen, and can later be used by the muscles for short periods of extreme use and to provide spurts of energy for a few minutes at a time. Moreover, glucose is an essential nutrient for brain and spinal cord function. Glucose is the only nutrient that can normally be utilized by the brain, retina, and germinal epithelium of the gonads in sufficient quantity to supply those organs with their required energy. Brain tissue has an obligate requirement for a steady supply of blood glucose. When blood glucose levels fall below 50 mg/dl, memory loss, agitation, confusion, irritability, sweating, tachycardia, and hypertension commonly occur. Brain failure occurs when blood glucose levels fall below 30 mg/dl, and is associated with coma, hypoventilation, and vascular instability. Death may occur. Therefore, it is important to maintain the blood glucose concentration at a high enough level to provide this necessary nutrition.
At the same time, however, it is also important that the blood glucose concentration not rise too high. Glucose exerts a large osmotic pressure in the extracellular fluid. If glucose concentration rises to excessive levels, this can draw water out of the cells and cause considerable cellular dehydration. Blood sugars above 200 mg/dl often exceed renal threshold producing an osmotic diuresis by the kidneys, which can deplete the body of fluids and electrolytes.
The steady supply of blood glucose is tightly controlled by the pancreas and the liver. Following a meal, gastric digestion and intestinal absorption provide an increasing amount of carbohydrates, free fatty acids, and amino acids into the portal venous blood. Sixty percent of the glucose absorbed after a meal is immediately stored in the liver in the form of glycogen. Between meals, when the glucose concentration begins to fall, liver glycogen is dephosphorolated, allowing large quantities of glucose to diffuse out of the liver cells and into the blood stream. The liver, a large organ, can store six percent of its mass as glycogen. In contrast, muscle tissue can store only two percent of its mass as glycogen, barely enough to be used by the muscle as its own energy reserve.
Normally, blood glucose concentration is regulated by two hormones, insulin and glucagon, secreted by the pancreas. Insulin is released in a bimodal fashion from the pancreas in direct response to a rise in blood glucose level and, to a lesser extent, to a rise in the blood level of free fatty acids and amino acids. Insulin promotes transport of these nutrients into the cells to b

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