In vitro determination of analyte levels within body fluids

• US 7,872,734 B2
• Filed: 06/14/2010
• Issued: 01/18/2011
• Est. Priority Date: 11/08/2001
• Status: Expired due to Fees

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Hartstein, Phillip C., Rule, Peter, Gable, Jennifer H., Braig, James R., Li, Kenneth I., Sterling, Bernhard B.
• Primary Examiner(s): PUNNOOSE, ROY M
• Application Number:
  US12/815,372
• Publication Number:
  US 20100249547A1
• Time in Patent Office: 218 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. An apparatus for determining the level of an analyte in a biological fluid sample from a patient, the apparatus comprising:

an analyte detection system configured to determine the level of at least one analyte in the biological fluid sample;

a sample extractor configured to withdraw the biological fluid sample through the skin of the patient;

a fluid separator configured to separate a first component of the biological fluid sample from other components thereof, wherein at least one of the other components would interfere with the measurement performed by the analyte detection system;

a disposable sample element comprising a sample cell and a sample supply passage in fluid communication with the sample cell, the sample cell configured to;

receive at least a portion of the first component of the biological fluid sample through the sample supply passage; and

hold the portion of the first component of the biological fluid sample between a first sample cell wall and a second sample cell wall of the sample cell while the analyte detection system analyzes the portion of the first component of the biological fluid sample to determine the level of the at least one analyte in the biological fluid sample;

wherein the disposable sample element is configured to be used more than once before being discarded.

2. The apparatus of claim 1, wherein the first component of the biological fluid sample comprises centrifuged blood.

3. The apparatus of claim 1, wherein the sample cell comprises a reagentless sample cell.

4. The apparatus of claim 1, wherein the fluid separator is operatively connected to the sample supply passage.

5. The apparatus of claim 1, wherein the fluid separator comprises a membrane.

6. 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.

7. The apparatus of claim 6, wherein the blood acquisition system comprises an external vacuum source.

8. The apparatus of claim 6, wherein the blood acquisition system comprises a pump.

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

10. The apparatus of claim 1, wherein the fluid separator comprises an in-line device for moving the fluid from the patient while at the same time separating the first component from the other components of the biological fluid sample.

11. The apparatus of claim 10, wherein the fluid separator is disposed between the sample extractor and the sample cell.

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

providing an analyte detection system configured to determine the level of at least one analyte in the biological fluid sample;

providing a disposable sample element configured to receive a portion of the biological fluid sample, the disposable sample element comprising a sample cell and a sample supply passage extending from and in fluid communication with the sample cell;

analyzing a first biological fluid sample by;

withdrawing the biological fluid sample from the patient;

moving at least a portion of the biological fluid sample through an in-line device configured to move the biological fluid sample while at the same time separating a first component of the biological fluid sample from other components thereof, wherein at least one of the other components would interfere with the measurement performed by the analyte detection system;

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

holding the at least a portion of the first component of the biological fluid sample in the sample cell while the analyte detection system analyzes the at least a portion of the first component of the biological fluid sample to determine the level of the at least one analyte in the biological fluid sample;

analyzing at least a second biological fluid sample using the disposable sample element by performing the same steps used to analyze the first biological fluid sample prior to removing and replacing the disposable sample element.

13. The method of claim 12, wherein the sample cell is at least partially defined by at least one window that is transmissive of infrared radiation.

14. The method of claim 12, wherein the sample cell comprising a reagentless sample cell.

15. The method of claim 12, wherein moving the at least a portion of the biological fluid sample through an in-line device comprises routing the biological fluid sample through a first selectable supply passage or through a second selectable supply passage in fluid communication with the sample cell.