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

• US 7,738,085 B2
• Filed: 12/23/2008
• Issued: 06/15/2010
• Est. Priority Date: 11/08/2001
• Status: Expired due to Fees

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Gable, Jennifer H., Braig, James R., Li, Kenneth I., Sterling, Bernhard B., Hartstein, Philip C., Rule, Peter
• Primary Examiner(s): Punnoose; Roy
• Application Number:
  US12/343,218
• Publication Number:
  US 20090213360A1
• Time in Patent Office: 539 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
• 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 centrifuged blood from a patient, the apparatus comprising:

a near-patient analyte detection system comprising;

a re-usable disposable element configured for removable engagement with the optical detection system, the re-usable disposable element comprising;

a reagentless sample cell configured to hold the centrifuged blood, the sample cell being adapted to engage with the analyte detection system to measure the concentration of an analyte in the biological fluid sample, 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 and a fluid source; and

an in-line device for moving the fluid from the fluid source while at the same time separating at least one component of the fluid from other components thereof, the in-line device being disposed between the fluid source and the reagentless sample cell.

2. The apparatus of claim 1, wherein the reagentless sample cell comprises a control system to route the sample through a first selectable supply passage or through a second selectable supply passage in fluid communication with the sample cell and a fluid source.

3. The apparatus of claim 1, further comprising a blood acquisition system 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.

4. The apparatus of claim 3, wherein the blood acquisition system comprises an external vacuum source.

5. The apparatus of claim 3, wherein the blood acquisition system comprises a pump.

6. The apparatus of claim 3, wherein the blood acquisition system comprises a plunger.

7. The apparatus of claim 1, wherein the reagentless sample cell comprises a first sample cell wall and a second sample cell wall, wherein said sample cell configured to hold the biological fluid sample between the first and second sample cell walls.

8. The apparatus of claim 1, wherein the analyte detection system further comprises:

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,

wherein the sample cell is located in the optical path upon engagement of the sample cell with the optical detection system.

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

[a] providing an analyte detection system configured to determine the concentration of at least one analyte in the biological fluid sample;

[b] withdrawing the biological fluid sample via a sample extractor through the skin of the patient;

[c] passing the biological fluid sample through a sample supply passage of a disposable sample element holder, said sample element holder comprising a sample cell;

[d] separating the biological fluid sample into at least a first component and a second component;

[e] causing at least a portion of said first component of the biological fluid sample to flow into a sample cell;

[f] holding the portion of said first component of the biological fluid sample between a first sample cell wall and a second sample cell wall of the sample cell;

[g] analyzing the portion of said first component of the biological fluid sample in the sample cell such by the analyte detection system to determine the concentration of the analyte in the biological fluid sample; and

[h] repeating at least steps [b]-[g] prior to removing and replacing the disposable sample element holder.

10. The method of claim 9, wherein at least one of said first component comprises centrifuged blood.