Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1999-04-21
2001-09-18
Lateef, Marvin M. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S473000, C600S310000, C600S121000
Reexamination Certificate
active
06292686
ABSTRACT:
TECHNICAL FIELD OF INVENTION
The invention relates to an apparatus and method for modulating temperature to alter tissue properties as well as blood and fluid content and flow in a tissue of a subject. The method facilitates the noninvasive measurement of analytes by modulating the temperature of the tissue being analyzed.
BACKGROUND OF THE INVENTION
There has long been considerable interest in the non-invasive monitoring of body chemistry. There are 16 million Americans with diabetes, all of whom would benefit from a method for non-invasive 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 non-invasive 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 non-invasive 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(l):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, interference from water, 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(l):13-19; K. Robinsen, 1998, Biophotonics Intematl 5(3):48-52). Previous attempts to provide methods for non-Invasive blood glucose monitoring are sunned 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
To overcome the limitations of the prior art, the invention provides a device and method for thermal tissue modulation. The device and method can be used with noninvasive spectroscopy, such as Raman spectroscopy, for the analysis of various features of tissue and blood in a subject.
The invention provides a tissue modulation device for use during spectroscopy of tissue of a subject. In one embodiment, the device comprises an inner sheath, an outer sheath and a window disposed through the inner and outer sheaths, wherein the inner and outer sheaths comprise a sufficiently flexible material that the device can be secured to a region of tissue to be spectroscopicaly probed, wherein the inner and outer sheaths are joined to one another so that at least one temperature regulating element can be disposed between the inner and outer sheaths, and wherein the window is sufficiently transparent that electromagnetic radiation can be delivered to and collected from an underlying tissue through the inner and outer sheaths.
In another embodiment, the device comprises means for altering the temperature of a region of tissue in a subject; means for securing the device to the tissue; and a window, wherein the window is sufficiently transparent that electromagnetic radiation can be delivered to and collected from an underlying tissue through the device. In one embodiment, the means for securing the device to tissue comprises a sheath, a fingerstall, a cuff, a strap, a molded sample holder or an adhesive.
In a preferred embodiment, the device further comprises a temperature regulating element disposed between the inner and outer sheaths. The device can further comprise a temperature sensing element disposed between the inner and outer sheaths. Preferably, the temperature regulating element comprises wire, such as, for example, teflon-coated nichrome. The temperature regulating element can include a heating element, or a cooling element, or both a heating and cooling element. Preferably, the device further comprises a heat transfer fluid within the space between the inner and outer sheaths. Examples of heat transfer fluid include, but are not limited to, glycerol, silicone and oil, such as olive oil. The heat transfer fluid can comprise a deuterated molecule.
In one embodiment of the device, the window comprises a substantially annular opening in the inner and outer sheaths. In another embodiment, the window comprises a lens. The window is preferably about 1 mm to about 10 mm in diameter.
The inner and outer sheaths of the device can be substantially cylindrical in shape, comprise a fingerstall, and/or comprise a cuff. Preferably, the flexible material comprises latex.
The invention additionally provides a method of modulating temperature of tissue in a subject to be spectroscopically probed. In a preferred embodiment, the method comprises applying a tissue modulation device of the invention to the tissue, passing current through the temperature regulating element so as to elevate or lower the temperature of the tissue, and passing electromagnetic radiation through the window of the device. Preferably, spectroscopic probing is performed when the temperature of the tissue has been elevated or lowered and when the temperature of the tissue is not elevated or lowered. The method can further comprise collecting Raman spectra emitted by the tissue.
The invention also provides a method for monitoring phase transitions, and thereby a method for determining lipid content and identity and protein content in a tissue of a subject. In a preferred embodiment, the method comprises applying a tissue modulation device of the invention to the tissue, passing current through the temperature regulating element so as to elevate or lower the temperature of the tissue, and passing electromagnetic radiation through the window of the device. Preferably, spectroscopic probing is performed when the temperature of the tissue has been elevated or lowered and when the temperature of the tissue is not elevated or lowered. The method can further comprise collecting Raman spectra emitted by the tissue. The collected spectra are then analyzed to determine the lipid content, lipid identity and/or protein content and identity of the tissue. Preferably, the analysis comprises determining the difference in number of Raman shifted photons emitted by the tissue at different temperatures.
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Chaiken Joseph
Peterson Charles M.
Gates & Cooper LLP
Lateef Marvin M.
LighTouch Medical, Inc.
Shaw Shawna J
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