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

• US 6,989,891 B2
• Filed: 08/14/2002
• Issued: 01/24/2006
• Est. Priority Date: 11/08/2001
• Status: Expired due to Fees

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Braig, James R., Hartstein, Philip C., Rule, Peter
• Primary Examiner(s): Lee, Hwa Andrew
• Assistant Examiner(s): Punnoose, Roy M.
• Application Number:
  US10/219,625
• Publication Number:
  US 20030086074A1
• Time in Patent Office: 1,259 Days
• Field of Search: 356/39, 356/246, 356/40, 356/41, 250/339.1, 250/339.2, 422/82.05, 600/347
• 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
• 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. An apparatus for determining the concentration of an analyte in a biological fluid sample drawn from a patient, the apparatus comprising:

a near-patient optical detection system comprising;

a source of electromagnetic radiation;

a detector;

an optical path extending between the source and the detector; and

a filter in the optical path, the filter configured to allow passage of at least one of the following wavelengths emitted by the source;

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; and

a sample element configured for removable engagement with the optical detection system, the sample element comprising;

a reagentless sample cell configured to hold the biological fluid sample, the sample cell being located in the optical path upon engagement of the sample cell with the optical detection system, the sample cell being defined by at least one window which is transmissive of infrared radiation;

a sample supply passage extending from and in fluid communication with the sample cell;

wherein the optical detection system further comprises a sample extractor configured to draw the biological fluid sample from the patient, and the sample supply passage is configured to conduct the biological fluid sample into the sample cell.

2. The apparatus of claim 1, further comprising a membrane in fluid communication with the sample cell, the membrane configured to filter the biological fluid sample.

3. The apparatus of claim 2, wherein the membrane is positioned within the sample supply passage.

4. The apparatus of claim 1, wherein the sample supply passage is configured to be engaged by the sample extractor upon engagement of the sample element with the optical detection system.

5. The apparatus of claim 1, further comprising a flow device that induces flow of biological fluid through the sample supply passage to the sample cell.

6. The apparatus of claim 5, wherein the flow device comprises a wicking material disposed in at least portion of the sample supply passage.

7. The apparatus of claim 1, further comprising a housing defining a chamber, the chamber 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 chamber.

8. The apparatus of claim 7, further comprising a visual display mounted to the housing, the visual display provides output based on at least one signal produced by the detector.

9. The apparatus of claim 1, wherein the source of electromagnetic radiation is 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 processor in communication with the detector, and a processor is configured to compare signals corresponding to the analyte beam and the calibration beam.

10. The apparatus of claim 1, wherein the sample element has a sample cell wall having a non-negligible absorption of the radiation emitted from the source of electromagnetic radiation.

11. The apparatus of claim 1, wherein the sample supply passage has a length that is greater than a width of the sample cell.