Surgery – Diagnostic testing – Measuring or detecting nonradioactive constituent of body...
Reexamination Certificate
2001-03-16
2003-07-08
Jeffery, John A. (Department: 3742)
Surgery
Diagnostic testing
Measuring or detecting nonradioactive constituent of body...
Reexamination Certificate
active
06591122
ABSTRACT:
BACKGROUND OF THE INVENTION
The maintenance of body fluid balance is of foremost concern in the care and treatment of critically ill patients, yet physicians have access to few diagnostic tools to assist them in this vital task. Patients with congestive heart failure, for example, frequently suffer from chronic systemic edema, which must be controlled within tight limits to ensure adequate tissue perfusion and prevent dangerous electrolyte disturbances. Dehydration of infants and children suffering from diarrhea can be life-threatening if not recognized and treated promptly.
The most common method for judging the severity of edema or dehydration is based on the interpretation of subjective clinical signs (e.g., swelling of limbs, dry mucous membranes), with additional information provided by measurements of the frequency of urination, heart rate, serum urea nitrogen SUN/creatinine ratios, and blood electrolyte levels. None of these variables alone, however, is a direct and quantitative measure of water retention or loss.
The indicator-dilution technique, which provides the most accurate direct measure of water in body tissues, is the present de facto standard for assessment of body fluid distribution. It is, however, an invasive technique that requires blood sampling. Additionally, a number of patents have disclosed designs of electrical impedance monitors for measurement of total body water. The electrical-impedance technique is based on measuring changes in the high-frequency (typically 10 KHz-1 MHz) electrical impedance of a portion of the body. Mixed results have been obtained with the electrical-impedance technique in clinical studies of body fluid disturbances as reported by various investigators. The rather poor accuracy of the technique seen in many studies point to unresolved deficiencies of these designs when applied in a clinical setting.
Therefore, there exists a need for methods and devices for monitoring total body water fractions which do not suffer from problems due to their being invasive, subjective and inaccurate.
SUMMARY OF THE INVENTION
Embodiments of the present invention provide devices and methods that measure body fluid-related metrics using spectrophotometry to facilitate therapeutic interventions aimed at restoring body fluid balance. The specific body fluid-related metrics include the absolute volume fraction of water in the extravascular and intravascular tissue compartments, as well as the shifts of water between these two compartments. The absolute volume fraction of water is determined using algorithms where received radiation measured at two or more wavelengths are combined to form either a single ratio, a sum of ratios or ratio of ratios of the form log [R(&lgr;
1
)/R(&lgr;
2
)] in which the received radiation in the numerator depends primarily on the absorbance of water and the received radiation in the denominator depends primarily on the absorbance of water and the sum of the absorbances of non-heme proteins and lipids in tissue.
The difference between the fraction of water in the intravascular fluid volume (“IFV”) and extravascular fluid volume (“EFV”) compartments are also determined using a differential method that takes advantage of the observation that pulsations caused by expansion of blood vessels in the skin, as the heart beats, produce changes in the received radiation at a particular wavelength that are proportional to the difference between the effective absorption of light in the blood and the surrounding tissue. This difference, integrated over time, provides a measure of the quantity of the fluid that shifts into and out of the capillaries. A mechanism for mechanically inducing a pulse is built into the device to improve the reliability of measurements of IFV-EFV under weak-pulse conditions.
For a fuller understanding of the nature and advantages of the embodiments of the present invention, reference should be made to the following detailed description taken in conjunction with the accompanying drawings.
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Jeffery John A.
Nellcor Puritan Bennett Incorporated
Townsend & Townsend & Crew LLP
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