Surgery – Miscellaneous – Methods
Patent
1997-01-17
1998-11-17
Yu, Mickey
Surgery
Miscellaneous
Methods
600322, 600316, A61B 1900
Patent
active
058363173
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to a process for transcutaneous and non-bloody in vivo determination of an analyte in blood.
2. Discussion of the Background
The number of persons suffering from diabetes, for example, particularly in highly industrialized countries, is extraordinarily high and is on the rise. The most recent estimates assume that there are 4 million people with this disease in the Federal Republic of Germany.
The treatment of this metabolic disease requires constant control and measurement of blood sugar content. Deviations from the norm lead to known latent injuries, whose result is, for example, blindness or amputation.
The currently available measurement methods are invasive, i.e., they require the withdrawal of blood and hence, injury to the patient. In comparison, a non-invasive, i.e., injury-free blood sugar measurement has a number of advantages which cannot be achieved with the known processes and methods.
A non-invasive procedure comparatively reduces the strain upon the diabetic patient, improves the adjustment precision of the blood sugar level for the prevention of latent injuries, in particular through the possibility of continuous registering of the blood sugar concentration, permits the testing of dynamic metabolic processes and the development of an artificial pancreas by designing a governing circuit for a blood sugar-insulin pump.
Until now, various methods have been considered which utilize chemical, biological, and physical processes or principles.
U.S. Pat. No. 5,137,023 discloses an embodiment in which an at first undetermined glucose quantity is measured by determining the absorption difference at a particular wavelength. The association of this measurement value with a corresponding glucose concentration in the blood, though, must still be carried out with a standard measurement for each patient, wherein the standard test sample naturally has to be withdrawn in a bloody manner. In this connection, it is assumed that the conditions at the measurement location or in the measurement area do not change. Temperature changes and changes in the sample thickness (e.g., fingertip or earlobe) can lead to deviations from the standard and thus can increase measurement error.
Changes in the measurement area, which likewise lead to increased measurement error, can be attributed to external physiological influences on the patient, such as stress, anger, and athletic activity. This is partially combated with correction values that take these influences (sample thickness, temperature measurement) into account.
With the known process, the total glucose content in the measurement area (blood, skin, tissue, bone) of a region of the body is additionally measured. Dynamic changes of the concentration in the blood can only be determined in terms of their direction.
U.S. Pat. No. 5,101,825 describes a process in which a quantity of a substance of interest is measured in parallel to the measurement of a reference volume.
Having the disadvantages mentioned, the precision of the known process leads to the fact that despite considerable uses in the research field, no possibility has been produced for completely non-invasive, in vivo measurement of blood sugar. Thus, for example, a regulation of the insulin that can be supplied with a pump as a function of the measured glucose concentration cannot be carried out precisely enough.
SUMMARY OF THE INVENTION
It is therefore the object of the invention to produce a possibility for in vivo measurement of the concentration of substances such as glucose, lactate, blood sugar, cholesterol, alcohol, drugs, or the like in the patient's blood in a completely non-bloody manner and with increased precision.
According to the invention, this object is attained by spectroscopically generating at least one first signal corresponding to at least one analyte quantity in a region of a body and at least one second signal corresponding to at least one water quantity in the region of the body; determining the at least one
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O'Hara Kelly
Yu Mickey
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