Reagent-less whole-blood glucose meter
First Claim
Patent Images
1. A method for determining the concentration of an analyte in a patient, in no particular sequence, comprising:
- providing an optical detection system which is portable and sized and configured to be small enough to fit in the palm or pocket of the patient, the detection system comprising a housing, at least one source of electromagnetic radiation, at least one detector, an optical path extending between the source and the detector, and a filtering system in the optical path, the filtering system configured to allow passage of at least one of the following wavelengths emitted by the source;
about 4.2 μ
m, about 5.25 μ
m, about 6.12 μ
m, about 7.4 μ
m, about 8.0 μ
m, about 8.45 μ
m, about 9.25 μ
m, about 9.65 μ
m, about 10.4 μ
m, about 12.2 μ
m;
providing a disposable sample element comprising a reagentless sample cell and an opening, the sample cell and the opening being in fluid communication through a sample supply passage, the sample cell being formed at least in part by at least one window constructed from a material selected from the group consisting of polyethylene and polypropylene;
installing the sample element into the housing of the optical detection system;
positioning the sample element such that the sample cell is located at least partially in the optical path and such that the opening of the sample element is exposed outside the housing;
extracting a sample of biological fluid from the patient;
contacting the opening of the sample element with the sample, such that a portion of the sample is drawn into the sample element;
transporting the sample portion from the opening to the sample cell through the supply passage via capillary action;
transmitting a calibration beam of radiation from the source through the sample element, but not through the sample portion, such that a calibration signal is generated by the optical detection system, the sample element having a first window separation where the calibration beam passes through the sample element;
transmitting an analyte beam of radiation from the source through the sample element and through the sample portion, such that an analyte signal is generated by the optical detection system, the sample element having a second window separation where the calibration beam passes through the sample element, the second window separation being different from the first window separation; and
correcting the analyte signal using the calibration signal to substantially eliminate the absorption of the sample element.
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Abstract
A reagentless whole-blood analyte detection system that is capable of being deployed near a patient has a source capable of emitting a beam of radiation that includes a spectral band. The whole-blood system also has a detector in an optical path of the beam. The whole-blood system also has a housing that is configured to house the source and the detector. The whole-blood system also has a sample element that is situated in the optical path of the beam. The sample element has a sample cell and a sample cell wall that does not eliminate transmittance of the beam of radiation in the spectral band.
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Citations
19 Claims
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1. A method for determining the concentration of an analyte in a patient, in no particular sequence, comprising:
-
providing an optical detection system which is portable and sized and configured to be small enough to fit in the palm or pocket of the patient, the detection system comprising a housing, at least one source of electromagnetic radiation, at least one detector, an optical path extending between the source and the detector, and a filtering system in the optical path, the filtering system configured to allow passage of at least one of the following wavelengths emitted by the source;
about 4.2 μ
m, about 5.25 μ
m, about 6.12 μ
m, about 7.4 μ
m, about 8.0 μ
m, about 8.45 μ
m, about 9.25 μ
m, about 9.65 μ
m, about 10.4 μ
m, about 12.2 μ
m;
providing a disposable sample element comprising a reagentless sample cell and an opening, the sample cell and the opening being in fluid communication through a sample supply passage, the sample cell being formed at least in part by at least one window constructed from a material selected from the group consisting of polyethylene and polypropylene;
installing the sample element into the housing of the optical detection system;
positioning the sample element such that the sample cell is located at least partially in the optical path and such that the opening of the sample element is exposed outside the housing;
extracting a sample of biological fluid from the patient;
contacting the opening of the sample element with the sample, such that a portion of the sample is drawn into the sample element;
transporting the sample portion from the opening to the sample cell through the supply passage via capillary action;
transmitting a calibration beam of radiation from the source through the sample element, but not through the sample portion, such that a calibration signal is generated by the optical detection system, the sample element having a first window separation where the calibration beam passes through the sample element;
transmitting an analyte beam of radiation from the source through the sample element and through the sample portion, such that an analyte signal is generated by the optical detection system, the sample element having a second window separation where the calibration beam passes through the sample element, the second window separation being different from the first window separation; and
correcting the analyte signal using the calibration signal to substantially eliminate the absorption of the sample element. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. An apparatus for determining the concentration of an analyte in a biological fluid sample drawn from a patient, to apparatus comprising:
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an optical detection system which is portable and sized and configured to be small enough to fit in the palm or pocket of the patient, the detection system comprising a housing, at least one source of electromagnetic radiation, at least one detector, an optical path extending between the source and the detector, and a filtering system in the optical path, the filtering system configured to allow passage of at least one of the following wavelengths emitted by the source;
about 4.2 μ
m, about 5.25 μ
m, about 6.12 μ
m, about 7.4 μ
m, about 8.0 μ
m, about 8.45 μ
m, about 9.25 μ
m, about 9.65 μ
m, about 10.4 μ
m, about 12.2 μ
m;
a patient-removable sample element comprising an opening and a reagentless sample cell configured to hold the biological fluid sample, the sample cell and the opening being in fluid communication through a capillary transport mechanism, the sample cell being defined at least in part by a pair of windows constructed from a material selected from the group consisting of polyethylene and polypropylene;
the sample element being removably installed in the housing of the optical detection system such that the sample cell is located at least partially in the optical path and such that the opening of the sample element is exposed outside the housing;
a calibration beam of radiation transmitted from the source through the sample element, but not through the biological fluid sample, and a corresponding calibration signal generated by the optical detection system, the sample element having a first window separation where the calibration beam passes through the sample element;
an analyte beam of radiation transmitted from the source through the sample element and through the biological fluid sample, and a corresponding analyte signal generated by the optical detection system, the sample element having a second window separation where the calibration beam passes through the sample element, the second window separation being different from the first window separation; and
a processor for correcting the analyte signal by using the calibration signal to substantially eliminate the absorption of the sample element. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19)
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Specification