Non-invasive system for the determination of analytes in body fluids
First Claim
1. A system for determining the concentration of an analyte in at least one body fluid in body tissue, the system comprising:
- an infrared light source;
a body tissue interface adapted to contact body tissue and to deliver light from the infrared light source to the contacted body tissue;
a detector adapted to receive spectral information corresponding to infrared light transmitted through the portion of body tissue being analyzed and to convert the received spectral information into an electrical signal indicative of the received spectral information; and
a central processing unit adapted to compare the electrical signal to an algorithm built upon correlation with the analyte in body fluid, the algorithm adapted to convert the received spectral information into the concentration of the analyte in at least one body fluid.
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Accused Products
Abstract
A system for determining the concentration of an analyte in at least one body fluid in body tissue, the system comprising an infrared light source, a body tissue interface, a detector, and a central processing unit. The body tissue interface is adapted to contact body tissue and to deliver light from the infrared light source to the contacted body tissue. The detector is adapted to receive spectral information corresponding to infrared light transmitted through the portion of body tissue being analyzed and to convert the received spectral information into an electrical signal indicative of the received spectral information. The central processing unit is adapted to compare the electrical signal to an algorithm built upon correlation with the analyte in body fluid, the algorithm adapted to convert the received spectral information into the concentration of the analyte in at least one body fluid.
60 Citations
112 Claims
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1. A system for determining the concentration of an analyte in at least one body fluid in body tissue, the system comprising:
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an infrared light source;
a body tissue interface adapted to contact body tissue and to deliver light from the infrared light source to the contacted body tissue;
a detector adapted to receive spectral information corresponding to infrared light transmitted through the portion of body tissue being analyzed and to convert the received spectral information into an electrical signal indicative of the received spectral information; and
a central processing unit adapted to compare the electrical signal to an algorithm built upon correlation with the analyte in body fluid, the algorithm adapted to convert the received spectral information into the concentration of the analyte in at least one body fluid. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. A method for determining the concentration of an analyte in at least one body fluid in body tissue, the method comprising:
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contacting body tissue to be analyzed;
compressing the contacted body tissue;
controlling the temperature of the body tissue such that the body tissue is maintained at substantially uniform temperature;
directing infrared light into the body tissue;
detecting infrared light transmitted through the body tissue;
analyzing the detected transmitted light using an algorithm built upon correlation with the analyte in the body fluid, the algorithm being adapted to convert the detected transmitted light into the concentration of the analyte in at least one body fluid; and
determining the concentration of the analyte in at least one body fluid. - View Dependent Claims (31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70)
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49. A system for determining the concentration of an analyte in at least one body fluid in body tissue, the system comprising:
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an infrared light source;
a body tissue interface adapted to contact body tissue and to deliver light from the infrared light source to contacted body tissue;
an index matching medium disposed between the body tissue interface and the received body tissue, wherein the infrared light delivered to the body tissue and reflected by the body tissue passes through the index matching medium;
a detector adapted to receive light reflected from the body fluid and to convert the received reflected light into an electrical signal indicative of the received reflected light; and
a central processing unit adapted to compare the electrical signal to an algorithm built upon correlation with the analyte in body fluids, the algorithm converting the received spectral information into the concentration of the analyte in at least one body fluid. - View Dependent Claims (50, 51, 52, 53, 54, 55, 71, 72, 73, 74, 75, 76)
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77. A method for determining the concentration of an analyte in at least one body fluid in body tissue, the method comprising:
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disposing an index matching medium on a surface of a body tissue interface;
contacting body tissue with the body tissue interface;
controlling the temperature of a contacted the body tissue to a substantially uniform temperature;
directing a beam of infrared light onto the body tissue;
detecting infrared light reflected from the body tissue;
comparing the detected reflected light to an algorithm built upon correlation with the analyte in body fluid, the algorithm adapted to convert the detected reflected light into the concentration of the analyte in at least one body fluid; and
determining the concentration of the analyte in at least one body fluid. - View Dependent Claims (78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 93, 94, 95, 96, 97)
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91. The method of 77 further comprising delivering the reflected light to a detector with a sapphire rod.
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92. The method of 77 wherein directing further comprises directing the infrared light through a plurality of fiber optic cables.
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98. A method for building an algorithm for converting spectral information obtained from body tissue into the concentration of glucose in at least one body fluid in the body tissue, the method comprising:
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modulating the concentration of glucose in at least one body fluid in the body tissue to a plurality of predetermined levels within a range of predetermined glucose concentration levels;
directing infrared light onto the body tissue of at least one test subject being analyzed during a glucose clamping test;
collecting spectral information from the body tissue;
collecting data other than spectral information from body tissue of the at least one test subject during the modulating of the concentration of glucose in at least one body fluid in the body tissue, modeling spectral information corresponding to glucose concentration levels outside the range of glucose concentration levels; and
filtering the collected and modeled spectral information to remove non-analyte spectral information using one or more established chemometric techniques selected from the group consisting of wavelets analysis, orthogonal signal correction, partial least squares regression, principal components analysis, and genetic algorithms. - View Dependent Claims (99, 100, 101, 102, 103, 104, 105, 106)
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107. A method for building an algorithm for converting spectral information obtained from body tissue into the concentration of glucose in at least one body fluid in the body tissue, wherein the glucose concentration level of the at least one body fluid in body tissue of a plurality of test subjects including a first test subject and a second test subject is modulated to a plurality of predetermined glucose concentration levels within a range of glucose concentration levels, the method comprising:
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invasively determining the glucose concentration levels of the at least one body fluid of each of the test subjects during the modulating of glucose concentration levels of the at least one body fluid in body tissue;
directing infrared light onto the body tissue the test subjects being analyzed during the glucose clamping test;
collecting spectral information from the body tissue of the test subjects;
normalizing the information collected from the body tissue of the test subjects;
combining a portion of the normalized spectral information collected from the first test subject with a portion of the normalized spectral information collected from the second test subject to create a combined spectral data set;
mean centering the combined spectral data set;
creating a partial least squares regression model having at least one orthogonal signal correction component from the combined spectral data set, the partial least squares regression model being adapted to filter out non-glucose related spectral information form the spectral data set;
applying an orthogonal signal correction analysis to the normalized spectral information collected from the first test subject to form a first corrected data set and to the normalized spectral information collected from the second test subject from a second corrected data set; and
applying the partial least squares regression model to first corrected data set and the invasively determined glucose concentration levels collected from the first test subject to form the algorithm for converting spectral information obtained from body tissue into the concentration of glucose in at least one body fluid in the body tissue. - View Dependent Claims (108, 109, 110, 111, 112)
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Specification