Surgery – Diagnostic testing – Measuring or detecting nonradioactive constituent of body...
Reexamination Certificate
1999-01-27
2001-04-24
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
Measuring or detecting nonradioactive constituent of body...
C600S335000
Reexamination Certificate
active
06223063
ABSTRACT:
Throughout this application various publications are referenced. The disclosures of these publications in their entireties are hereby incorporated by reference into this application in order to more fully describe the state of the art to which this invention pertains.
TECHNICAL FIELD OF INVENTION
The invention relates to a method and device for modulating blood flow in tissue. Mechanical pressure is applied to a region of tissue in order to affect the flow and presence of blood in the associated capillary bed. The method facilitates the noninvasive measurement of blood analytes.
BACKGROUND OF THE INVENTION
There has long been considerable interest in the noninvasive monitoring of body chemistry. There are 16 million Americans with diabetes, all of whom would benefit from a method for noninvasive measurement of blood glucose levels. Using currently accepted methods for measuring blood glucose levels, many diabetics must give blood five to seven times per day to adequately monitor their health status. With a noninvasive blood glucose measurement, closer control could be imposed and the continuing damage, impairment and costs caused by diabetes could be minimized.
Blood oximetry is an example of an application of electronic absorption spectroscopy to noninvasive monitoring of the equilibrium between oxygenated and deoxygenated blood (U.S. Pat. No. 5,615,673, issued Apr. 1, 1997). Similarly, vibrational spectroscopy is a reliable mode of quantitative and qualitative ex vivo analysis for complex mixtures, and there are reports of in vitro applications of this method to metabolically interesting analytes (S. Y. Wang et al, 1993, Analysis of metabolites in aqueous solution by using laser Raman spectroscopy, Applied Optics 32(6):925-929; A. J. Berger et al., 1996, Rapid, noninvasive concentration measurements of aqueous biological analytes by near infrared Raman spectroscopy, Applied Optics 35(1):209-212). Infrared measures, such as vibrational absorption spectroscopy, have been applied to skin tissue, but with success limited by unavailability of suitable light sources and detectors at crucial wavelengths, and by heating of the tissue due to the absorption of incident radiation (U.S. Pat. No. 5,551,422, see also R. R. Anderson and J. A. Parrish, 1981, The Optics of Human Skin, J. Investigative Dermatology 77(1):13-19). Previous attempts to provide methods for noninvasive blood glucose monitoring are summarued in U.S. Pat. No. 5,553,616, issued on Sep. 10, 1996.
Optimal application of noninvasive techniques for blood analysis will require improved methods for isolating signals attributable to blood versus surrounding tissues.
SUMMARY OF THE INVENTION
The invention provides a device and methods to meet this need for obtaining signals related to blood analytes. The invention provides a tissue modulation device comprising an upper surface and a lower surface, wherein the upper surface comprises a recessed region adjacent to a raised region, wherein the device is optically transparent in at least one of the recessed region or the raised region, wherein application of a first portion of a tissue to the raised region depresses the first portion of the tissue relative to a second portion of the tissue that is in apposition to the recessed region, and wherein the optically transparent region of the device is curved at the lower surface to substantially reduce backscattered light in a light path traveling through the optically transparent region to a light collection system. In one embodiment, the raised region is opaque. In another embodiment, the raised region is optically transparent. In one embodiment, the recessed region is optically transparent. The recessed region can optionally be recessed relative to an adjacent portion of the upper surface of the device.
In one embodiment, the device further comprises a series of alternating recessed and raised regions coupled so as to form a continuous loop, and at least one rotatable sprocket engaged with the loop such that rotation of the sprocket effects rotation of the loop. The raised region can comprise a substantially cylindrical roller. The recessed region can comprise a length having a first end and a second end, and the recessed region can further comprise a substantially rectangular cross-section, adjoined at an end by a portion having a substantially circular cross-section.
The invention additionally provides a method of noninvasive spectroscopic measurement of an analyte in a subject. The method comprises applying tissue of the subject to a tissue modulation device comprising a recessed region adjacent to a raised region so that the raised region depresses a first portion of tissue relative to a second portion of tissue in apposition to the recessed region. The method further comprises irradiating the tissue in a blood-replete state with electromagnetic radiation having an excitation wavelength, and collecting the spectra emitted by the tissue in the blood-replete state. The method further comprises irradiating the tissue in a blood-depleted state with electromagnetic radiation having an excitation wavelength, and collecting the spectra emitted by the tissue in the blood-depleted state. The collected spectra are then analyzed to determine a concentration of analyte present in the tissue. The analyzing comprises determining the difference between the spectra collected in the blood-replete and blood-depleted states. The spectra are preferably Raman spectra. Examples of other spectra include, but are not limited to, NMR, ESR, UV visible absorption, IR absorption, fluorescence and phosphorescence spectra.
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Chaiken Joseph
Peterson Charles M.
Gates & Cooper LLP
LighTouch Medical, Inc.
Winakur Eric F.
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