Reagent-less whole-blood glucose meter

• US 7,050,157 B2
• Filed: 07/19/2002
• Issued: 05/23/2006
• Est. Priority Date: 11/08/2001
• Status: Expired due to Term

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Braig, James R., Zheng, Peng, Li, Kenneth I., Sterling, Bernhard B., Hartstein, Philip C., Rule, Peter, Goldberger, Daniel S., Hall, W. Dale, Witte, Kenneth G., Gaffney, Robert D., Cortella, Julian M., Agostino, Mark D.
• Primary Examiner(s): Nguyen, Tu T.
• Application Number:
  US10/200,384
• Publication Number:
  US 20030086073A1
• Time in Patent Office: 1,404 Days
• Field of Search: 356 36- 42, 356432-444, 604 19- 27, 600573-578, 600/345, 600/365
• US Class Current: 356/39
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150061 Means for enhancing collection
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150458 Specific blade design, e.g. for improved cutting and penetration characteristics
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips
• CPC Class Codes: G01N 21/35 using infrared light G01N21/39 takes precedence

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.

Claims

1. A reagentless glucose detection system sized and configured to be portably carried by a patient, comprising:

a modulated source capable of emitting a beam of radiation;

a detector in an optical path of the beam;

a synchronous demodulator in communication with the detector;

a housing sized and configured to be portable and used by the patient, and to house the source and the detector;

a receptacle formed in said housing for manually receiving a sample element, the receptacle being sized and configured such that at least a portion of the sample element is situated in the optical path when the sample element is situated in the receptacle; and

a disposable sample element removably situated in the receptacle of the housing and constructed at least in part from a material through which the radiation can pass, the sample element comprising;

a sample cell wall having a non-negligible absorption of the radiation in a spectral band; and

a sample cell configured to be at least partially filled by the patient with a sample from the patient;

further comprising a filtering system in the optical path of the beam, the filtering system configured to transmit the spectral band of radiation;

wherein the filtering system is configured to transmit radiation at at least one of the following center wavelengths;

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.

2. The detection system of claim 1, wherein the filtering system is configured to transmit one selected from a group consisting of a plurality of spectral bands and a plurality of wavelengths.

3. The detection system of claim 1, wherein the filtering system is rotatable about an axis.

4. The detection system of claim 1, wherein the sample element further comprises an opening and a sample supply passage, the sample supply passage extending between the opening and the sample cell.

5. The detection system of claim 1, wherein the housing is sized and configured to be small enough to fit in the palm or pocket of the patient.

6. The detection system of claim 1, wherein the material through which radiation can pass is selected from a group consisting of polyethylene and polypropylene.

7. The detection system of claim 1, wherein at least a portion of the sample element extends from the housing when the sample cell is positioned in the optical path of a beam of radiation emitted from the modulated source.

8. The detection system of claim 1, wherein the modulated source is capable of emitting a first and a second of beam of radiation, the sample cell positioned in the optical path of the first beam and a second portion of the sample element positioned in the optical path of the second beam.

9. The detection system of claim 8, wherein the second portion of the sample element is a calibration portion constructed from material selected from the group consisting of polyethylene and polypropylene.

10. A reagentless analyte detection system capable of being deployed near a patient comprising:

a modulated source capable of emitting (i) an analyte beam of radiation comprising a spectral band having a center wavelength, and (ii) a calibration beam of radiation;

a detector in an optical path of the analyte beam;

a synchronous demodulator in communication with the detector;

a processor in communication with the detector, the processor configured to compare signals corresponding to the analyte beam and the calibration beam;

a housing configured to house the source and the detector;

a disposable sample element situated in the optical path of the analyte beam and in an optical path of the calibration beam, the sample element configured to be filled with a sample, the sample element comprising;

a sample cell wall having a non-negligible absorption of the radiation in a spectral band; and

a sample cell; and

a filtering system in the optical path of the analyte beam, the filtering system configured to transmit radiation at at least one of the following center wavelengths;

about 5.25 μ

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.

11. The reagentless analyte detection system of claim 10, wherein the filtering system is configured to transmit one selected from a group consisting of a plurality of spectral bands and a plurality of wavelengths.

12. The reagentless analyte detection system of claim 10, wherein the optical path of the analyte beam of radiation is spaced from the optical path of the calibration beam of radiation.

13. The reagentless analyte detection system of claim 10, wherein the sample cell comprises a calibration portion, the sample cell is sized and configured such that the sample cell is situated along the optical path of the analyte beam when the calibration portion is situated along the optical path of the calibration beam.

14. The reagentless analyte detection system of claim 13, wherein the calibration portion comprises a calibration portion wall formed of a first material and the sample cell wall is formed of a second material.

15. The reagentless analyte detection system of claim 14, wherein the thickness of the calibration portion wall and the thickness of the sample cell wall are about same, the first material and second material have transmissive properties that are about the same.

16. The reagentless analyte detection system of claim 14, wherein the calibration portion comprises a calibration window and the sample cell wall comprises a plurality of sample windows.

17. The reagentless analyte detection system of claim 10, wherein the sample element further comprises a passage that extends from the sample cell, the passage adapted to deliver fluid to the sample cell.