Analyte monitoring systems and methods

• US 9,404,852 B2
• Filed: 07/18/2014
• Issued: 08/02/2016
• 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., Rule, Peter, Hartstein, Philip C., Sterling, Bernhard B., Gable, Jennifer H., Li, Kenneth I.
• Primary Examiner(s): Punnoose, Roy M
• Application Number:
  US14/335,491
• Publication Number:
  US 20150168294A1
• Time in Patent Office: 746 Days
• Field of Search: 356/39
• US Class Current: 1/1
• 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 cuvette for use with an optical measurement system, the cuvette comprising:

a first plate comprising a first window that is transparent to light emitted by the optical measurement system;

a second plate comprising a second window that is transparent to the light emitted by the optical measurement system;

a first spacer disposed between the first and the second plates; and

a second spacer disposed between the first and the second plates, the first and the second spacers disposed to provide a sample supply passageway between the first and the second plates, the sample supply passageway having an opening disposed between the first and the second plates.

2. The cuvette of claim 1, wherein the first spacer or the second spacer is an adhesive that secures the first plate to the second plate.

3. The cuvette of claim 1, wherein the first and the second window comprise at least one of polyethylene, polypropylene or silicon.

4. The cuvette of claim 1, wherein the cuvette forms a sample chamber between the first window, the second window and the first and second spacers the sample chamber configured to receive a sample of fluid for measurement through the sample supply passageway.

5. A fluid analysis system comprising:

the cuvette of claim 1; and

an optical measurement system comprising an optical source and an optical detector, and wherein the cuvette is configured to be disposed in an optical path between the optical source and the optical detectors such that light emitted from the optical source passes through the first and second windows towards the detector.

6. The cuvette of claim 1, wherein the first and the second window are transparent to mid-infrared light.

7. A fluid analysis system comprising:

a fluid handling system that includes a sample extractor configured to draw a sample of bodily fluid from a patient;

a fluid measurement system configured to measure the concentration of an analyte in the portion of the sample of bodily fluid; and

a sample analysis chamber configured to hold the sample of bodily fluid, the sample analysis chamber comprising;

a first window that is transparent to light emitted by the fluid measurement system;

a second window that is transparent to light emitted by the fluid measurement system; and

a first spacer and a second spacer positioned between the first window and the second piece to provide a gap between the first window and the second window, the first and the second spacers disposed to provide a sample supply passageway between the first and the second windows, the sample supply passageway having an opening disposed between the first and the second windows.

8. The fluid analysis system of claim 7, wherein the bodily fluid comprises whole blood.

9. The fluid analysis system of claim 7, wherein the sample of bodily fluid comprises centrifuged blood.

10. The fluid analysis system of claim 7, wherein the sample of bodily fluid comprises hemolysed blood.

11. The fluid analysis system of claim 7, further comprising a membrane configured to filter out components from the sample of bodily fluid.

12. The fluid analysis system of claim 7, wherein the first window and the second window are transparent to mid-infrared light.