Surgery – Diagnostic testing – Measuring or detecting nonradioactive constituent of body...
Reexamination Certificate
1998-05-18
2003-12-09
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
Measuring or detecting nonradioactive constituent of body...
C600S310000, C600S322000, C600S473000, C600S476000
Reexamination Certificate
active
06662030
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to devices and methods for measuring the concentration of one or more analytes in a human body part. More specifically, this invention relates to devices and methods for the noninvasive determination of in vivo analyte concentrations under conditions of precise temperature control.
2. Discussion of the Art
Non-invasive optical monitoring of metabolites is an important tool for clinical diagnostics. The ability to determine an analyte, or a disease state, in a human subject without performing an invasive procedure, such as removing a sample of blood or a biopsy specimen, has several advantages. These advantages include ease of performing the test, reduced pain and discomfort, and decreased exposure to potential biohazards. The result will be increased frequency of testing, accurate monitoring and control, and improved patient care. Representative examples of non-invasive measurements include pulse oximetry for oxygen saturation (U.S. Pat. Nos. 3,638,640; 4,223,680; 5,007,423; 5,277,181; 5,297,548), laser Doppler flowmetry for diagnosis of circulation disorder (Toke et al, “Skin microvascular blood flow control in long duration diabetics with and without complication”, Diabetes Research, Vol. 5, Pages 189-192, 1987), determination of tissue oxygenation (WO 92/20273), determination of hemoglobin (U.S. Pat. No. 5,720,284) and of hematocrit (U.S. Pat. Nos. 5,553,615; 5,372,136; 5,499,627; WO 93/13706).).
Measurements in the near-infrared spectral region are commonly proposed, or used, in prior art technologies. The 600-1100 nm region of the spectrum represents a window between the visible hemoglobin and melanin absorption bands and the infrared strong water absorption band. Light can penetrate deep enough in the skin to allow use in a spectral measurement or a therapeutic procedure.
Oximetry measurement is very important for critical patient care, especially after use of anesthesia. Oxygenation measurements of tissue are also important diagnostic tools for measuring oxygen content of the of the brain of the newborn during and after delivery and for sports medicine and tissue healing monitoring. Non-invasive determination of hemoglobin and hematocrit would offer a simple non-biohazardous painless procedure for use in blood donation centers, thereby increasing the number of donations by offering an alternative to the invasive procedure, which is inaccurate and could lead to rejection of a number of qualified donors. Hemoglobin and hematocrit values are useful for the diagnosis of anemia in infants and mothers, without the pain associated with pediatric blood sampling. Non-invasive determination of hemoglobin has been studied in the art as a method for localizing tumors and diagnosis of hematoma and internal bleeding. Non-invasive hematocrit measurements can yield important diagnostic information on patients with kidney failure before and during dialysis. There are more than 50 million dialysis procedures performed in the United Stated and close to 80 million procedures performed world-wide per year.
The most important potential advantage for non-invasive diagnostics possibly will for non-invasive diagnosis of diabetes. Diabetes mellitus is a chronic disorder of carbohydrate, fat, and protein metabolism characterized by an absolute or relative insulin deficiency, hyperglycemia, and glycosuria. At least two major variants of the disease have been identified. “Type I” accounts for about 10% of diabetics and is characterized by a severe insulin deficiency resulting from a loss of insulin-secreting beta cells in the pancreas. The remainder of diabetic patients suffer from “Type II”, which is characterized by an impaired insulin response in the peripheral tissues (Robbins, S. L. et al.,
Pathologic Basis of Disease,
3rd Edition, W. B. Saunders Company, Philadelphia, 1984, p. 972). If uncontrolled, diabetes can result in a variety of adverse clinical manifestations, including retinopathy, atherosclerosis, microangiopathy, nephropathy, and neuropathy. In its advanced stages, diabetes can cause blindness, coma, and ultimately death.
The principal treatment for Type I diabetes is periodic insulin injection. Appropriate insulin administration can prevent, and even reverse, some of the adverse clinical outcomes for Type I diabetics. Frequent adjustments of the blood glucose level can be achieved either by discrete injections or, in severe cases, via an implanted insulin pump or artificial pancreas. The amount and frequency of insulin administration is determined by frequent or, preferably, continuous testing of the level of glucose in blood (i. e., blood glucose level).
Tight control of blood glucose in the “normal range”, 60-120 mg/dL, is necessary for diabetics to avoid or reduce complications resulting from hypoglycemia and hyperglycemia. To achieve this level of control, the American Diabetes Association recommends that diabetics test their blood glucose five times per day. Thus, there is a need for accurate and frequent or, preferably, continuous glucose monitoring to combat the effects of diabetes.
Conventional blood glucose measurements in a hospital or physician's office rely on the withdrawal of a 5-10 mL blood sample from the patient for analysis. This method is slow and painful and cannot be used for continuous glucose monitoring. An additional problem for hospitals and physician offices is the disposal of testing elements that are contaminated by blood.
Implantable biosensors have also been proposed for glucose measurement. (G. S. Wilson, Y. Zhang, G. Reach, D. Moatti-Sirat, V. Poitout, D. R. Thevenot, F. Lemonnier, and J.-C. Klein, Clin. Chem. 38, 1613 (1992)). Biosensors are electrochemical devices having enzymes immobilized at the surface of an electrochemical transducer.
Portable, “minimally-invasive” testing systems are now commercially available. These systems require the patient to stick themselves to obtain a drop of blood which is then applied to a disposable test strip containing coated reagents or an electrochemical test element.
Although the portable instruments that read the strips are relatively inexpensive ($100-$200), the cumulative cost to diabetics for the disposable strips is considerable. Compliance is another major problem for minimally invasive techniques. Finger sticks are painful and can result in infections, scarring, and nerve damage in the finger. Disposal of potentially biohazardous test strips and lancets is yet another problem with these systems.
“Non-invasive” (alternatively referred to herein as “NI”) glucose sensing techniques measure in-vivo glucose concentrations without collecting a blood sample. As defined herein, a “non-invasive” technique is one that can be used without removing a sample from, or without inserting any instrumentation into, the tissues. The concept involves irradiating a vascular region of the body with electromagnetic radiation and measuring the spectral information that results from one of four primary processes: reflection, absorption, scattering, and emission. The extent to which each of these processes occurs is dependent upon a variety of factors, including the wavelength and polarization state of the incident radiation and the glucose concentration in the body part. Glucose concentrations are determined from the spectral information by comparing the measured spectra to a calibration curve or by reference to a physical model of the tissue under examination. Various categories of non-invasive glucose measurement techniques will now be described.
NI techniques that utilize the absorption of infrared radiation can be divided into three distinct wavelength regimes: Near-infrared (NIR), Mid-infrared (MIR) and Far-infrared (FIR). As defined herein, NIR involves the wavelength range from about 600 nm to about 1200 nm, MIR involves the wavelength range from about 1200 nm to about 3000 nm and FIR involves the wavelength range from about 3000 nm to about 25000 nm. As defined herein, “infrared” (or IR) is taken to mean a range of wavelengths from about
Bolt René A.
de Mul Frits F. M.
Hanna Charles F.
Kanger Johannes S.
Khalil Omar S.
Abbott Laboratories
Weinstein David L.
Winakur Eric F.
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