Device and method for in vitro determination of analyte concentrations within body fluids

• US 7,480,032 B2
• Filed: 01/23/2006
• Issued: 01/20/2009
• Est. Priority Date: 11/08/2001
• Status: Expired due to Term

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Sterling, Bernard B., Gable, Jennifer H., Braig, James R., Li, Kenneth I., Hartstein, Philip C., Rule, Peter
• Primary Examiner(s): Punnoose; Roy M
• Application Number:
  US11/337,943
• Publication Number:
  US 20060268258A1
• Time in Patent Office: 1,093 Days
• Field of Search: 356/39, 356/40, 356/41, 356/246
• US Class Current: 356/39
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• 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 5/1411 by percutaneous method, e.g. by lancet
• 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 5/150083 by vibration, e.g. ultrasound
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150717 manually removed
• 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 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15136 by use of radiation, e.g. laser
• CPC Class Codes: A61B 5/1514 : by use of gaseous agents, e.g. using suction aspiration or pressurized gas
• CPC Class Codes: A61B 5/15194 : fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• 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 2021/0389 : Windows
• CPC Class Codes: G01N 21/03 : Cuvette constructions
• CPC Class Codes: G01N 21/0332 : with temperature control control of temperature G05D23/00; cryostats F17C3/08
• CPC Class Codes: G01N 21/35 : using infrared light G01N21/39 takes precedence
• CPC Class Codes: G01N 21/3577 : for analysing liquids, e.g. polluted water
• CPC Class Codes: G01N 21/3581 : using far infrared light; using Terahertz radiation
• CPC Class Codes: G01N 2201/02 : Mechanical
• CPC Class Codes: G01N 2201/068 : Optics, miscellaneous
• CPC Class Codes: G01N 33/49 : Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/66 : involving blood sugars, e.g. galactose

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 method for determining the concentration of an analyte in a biological fluid, the method comprising:

emitting infrared electromagnetic radiation along an optical path;

passing the electromagnetic radiation through a filter, wherein the electromagnetic radiation passing through the filter has at least one of the following wavelengths;

about 5.25 μ

m, about 6.12 μ

m, about 7.4 m, about 8.0 μ

m, about 8.45 μ

m, about 9.25 μ

m, about 10.4 μ

m, about 12.2 μ

m;

drawing a biological fluid into an analyzer with a sample extractor;

separating out a portion from the biological fluid to create a biological fluid sample, wherein separating comprises separating components of the biological fluid that interfere with optical measurement;

passing the biological fluid sample from the sample extractor through a sample supply passage of a sample element into a reagentless sample cell of the sample element;

holding the biological fluid sample in the sample cell such that the sample cell is located in the optical path;

passing the infrared electromagnetic radiation through the sample cell and the biological fluid sample to a detector; and

calculating the concentration of the analyte based on the infrared electromagnetic radiation detected by the detector;

wherein the infrared electromagnetic radiation comprises an analyte beam of radiation comprising a spectral band having a center wavelength.

2. The method of claim 1, wherein the infrared electromagnetic radiation comprises a calibration beam of radiation in communication with the detector.

3. The method of claim 2, further comprising comparing signals corresponding to the analyte beam and the calibration beam.

4. The method of claim 1, further comprising filtering the biological fluid sample before the biological fluid sample is passed into the sample cell.

5. The method of claim 4, wherein the biological fluid sample is filtered as the biological fluid sample flows along the sample supply passage.

6. The method of claim 1, further comprising positioning at least a portion of the sample element in a chamber defined by a housing such that the sample element is in the optical path.

7. The method of claim 1, further comprising absorbing an effective amount of said infrared electromagnetic radiation with a sample cell wall of the sample cell.

8. The method of claim 1, further comprising outputting data on a visual display based on at least one signal from a detector receiving at least a portion of the infrared electromagnetic radiation, after the infrared electromagnetic radiation passes through the biological fluid sample.

9. The method of claim 1, wherein separating out a portion from the biological fluid to create a biological fluid sample further comprises removing components of the biological fluid that might complicate the optical measurement.

10. The method of claim 1, wherein separating out a portion from the biological fluid to create a biological fluid sample further comprises filtering out components of the biological fluid.

11. The method of claim 10, wherein filtering out components of the biological fluid comprises filtering out blood components from whole blood.

12. The method of claim 10, wherein filtering out components of the biological fluid comprises filtering through a membrane.

13. The method of claim 12, wherein filtering through a membrane comprises filtering through a filter positioned in the sample supply passage.

14. The method of claim 1, wherein passing the biological fluid sample from the sample extractor through a sample supply passage of a sample element into a reagentless sample cell of the sample element comprises passing biological fluid through a membrane that moves the biological fluid while at the same time filtering to create a biological fluid sample by separating out, from the biological fluid, components of the biological fluid that might complicate the optical measurement.

15. The method of claim 1, wherein separating out a portion from the biological fluid to create a biological fluid sample further comprises dividing whole blood into plasma and non-plasma portions.

16. A method for determining the concentration of an analyte in a biological fluid sample from a patient, the method comprising:

emitting infrared electromagnetic radiation along an optical path;

passing the electromagnetic radiation through a filter, wherein the electromagnetic radiation passing through the filter has at least one of the following 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 10.4 μ

m, about 12.2 μ

m;

drawing the biological fluid sample from the patient with a sample extractor;

passing the biological fluid sample from the sample extractor through a sample supply passage of a sample element into a reagentless sample cell of the sample element;

separating out at least one interfering component from the biological fluid sample to create a measurement portion and a non-measurement portion, the measurement portion substantially excluding the at least one interfering component;

holding the measurement portion of the biological fluid sample in the sample cell such that the sample cell is located in the optical path;

passing the infrared electromagnetic radiation through the sample cell and the measurement portion of the biological fluid sample;

detecting the infrared electromagnetic radiation passed through the sample cell and the measurement portion; and

calculating the concentration of the analyte based on the infrared electromagnetic radiation detected.

17. The method of claim 16, wherein separating out interfering components from the biological fluid sample to create a measurement portion comprises separating out blood plasma from whole blood.

18. A method for determining the concentration of an analyte in a biological fluid sample from a patient, the method comprising:

emitting infrared electromagnetic radiation along an optical path;

providing the electromagnetic radiation such that it exhibits at least one wavelength indicative of the analyte;

drawing the biological fluid sample from the patient;

passing the biological fluid sample through a sample supply passage of a sample element into a reagentless sample cell of the sample element, wherein passing the biological fluid into a reagentless sample cell comprises separating the biological fluid into at least a first component and a second component;

holding a biological fluid sample in the sample cell such that at least one of said first component and said second component is located in the optical path;

passing the infrared electromagnetic radiation through the sample cell and at least one of said first component and said second component of the biological fluid sample;

detecting the electromagnetic radiation passed through the sample cell and at least one of said first component and said second component; and

calculating the concentration of the analyte based on the electromagnetic radiation detected.

19. The method of claim 18, wherein separating the biological fluid comprises isolating blood plasma.

20. The method of claim 18, wherein separating the biological fluid comprises filtering blood plasma from whole blood.