Analyte monitoring systems and methods

• US 8,786,838 B2
• Filed: 03/16/2012
• Issued: 07/22/2014
• 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., Rule, Peter, Hartstein, Philip C., Sterling, Bernhard B., Gable, Jennifer H., Li, Kenneth I.
• Primary Examiner(s): Punnoose, Roy M
• Application Number:
  US13/423,029
• Publication Number:
  US 20120330115A1
• Time in Patent Office: 858 Days
• Field of Search: 356/39
• 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 system for determining the level of an analyte in a biological fluid sample from a patient, the system comprising:

an analyte detector 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; and

a multi-use disposable sample element comprising;

a sample cell configured to receive at least a portion of the biological fluid sample and to hold that portion while the analyte detector analyzes the portion of the biological fluid sample;

a sample supply passage in fluid communication with the sample cell and configured to facilitate entry of the at least a portion into the sample cell; and

a container configured to store discarded biological material.

2. The system of claim 1, wherein the sample cell is configured to hold the portion 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.

3. The system of claim 1, wherein the apparatus comprises a fluid separator configured to separate a first component of the biological fluid sample from other components thereof.

4. The system of claim 1, wherein the sample cell comprises a reagentless sample cell.

5. The system of claim 1, further comprising a blood acquisition system configured to draw the biological fluid sample from the patient, wherein the sample supply passage is configured to conduct the biological fluid sample into the sample cell.

6. The system of claim 1, wherein the multi-use disposable sample element comprises multiple sample cells, and the container includes a housing configured to store multiple used sample elements, each of which retains biological material from previous measurements.

7. The system of claim 1, wherein the multi-use disposable sample element is insertable into a housing of the analyte detector.

8. The system of claim 7, wherein the multi-use disposable sample element comprises a calibration portion configured to be positioned in the optical path of a calibration beam when the multi-use disposable sample element is inserted into the housing of the analyte detector.

9. The system of claim 8, wherein the multi-use disposable sample element comprises an analysis portion configured to be positioned in the optical path of an analyte transmission beam when the multi-use disposable sample element is inserted into the housing of the analyte detector.

10. The system of claim 9, further comprising a filter configured to split a radiation beam into a split beam comprising the calibration beam and the analyte transmission beam.

11. An apparatus comprising:

a multi-use disposable sample element for use with a system configured to perform multiple analyses on biological fluid samples from a patient, wherein the multi-use disposable sample element comprises;

a sample cell configured to receive at least a portion of a biological fluid sample and to hold that portion while an analyte detector analyzes the portion of the biological fluid sample;

a sample supply passage in fluid communication with the sample cell and configured to facilitate entry of the at least a portion into the sample cell; and

a container configured to receive and store discarded biological material after each of the multiple analyses.

12. The apparatus of claim 11, wherein the container is further configured to collect discarded material from multiple.

13. The apparatus of claim 11, further comprising a second sample cell for a second analysis.

14. The apparatus of claim 11, wherein the biological material is a biohazardous material.

15. A method of using a multi-use disposable sample element comprising a sample cell and a container for discarded biological material with an analyte detection system configured to perform multiple analyses on biological fluid samples from a patient, the method comprising:

a. extracting a sample of biological fluid from the patient;

b. directing at least a portion of the sample of biological fluid through a sample supply passage that is in fluid communication with the sample cell and that is configured to facilitate entry of the at least a portion of the sample into a sample cell;

c. directing the at least a portion of the sample into the sample cell;

d. holding the at least a portion of the sample in the sample cell while an analyte detector analyzes the at least a portion of the sample;

e. after the at least a portion of the sample is analyzed, directing the at least a portion of the sample into the container, wherein the container is configured to receive and store discarded biological material; and

repeating at least a-e multiple times before disposing of the multi-use disposable sample element.

16. The method of claim 15, further comprising inserting the multi-use disposable sample element into a housing of the analyte detection system.

17. The method of claim 16, further comprising positioning a calibration portion of the multi-use disposable sample element comprises in the optical path of a calibration beam when the multi-use disposable sample element is inserted into the housing of the analyte detection system.

18. The method of claim 17, further comprising positioning an analysis portion of the multi-use disposable sample element in the optical path of an analyte transmission beam when the multi-use disposable sample element is inserted into the housing of the analyte detection system.

19. The method of claim 18, further comprising splitting a radiation beam into a split beam comprising the calibration beam and the analyte transmission beam.

20. The method of claim 15, further comprising separating the at least a portion of the sample of biological fluid into biological fluid components.