Analyte monitoring systems and methods

• US 9,907,504 B2
• Filed: 08/01/2016
• Issued: 03/06/2018
• 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:
  US15/225,079
• Publication Number:
  US 20170172480A1
• Time in Patent Office: 582 Days
• Field of Search: 356 39, 356 40, 356 41
• 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 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 disposable sample element configured to be used more than once before being discarded, the disposable sample element comprising;

a sample cell configured to hold the sample of bodily fluid, the sample cell comprising at least one window transparent to light;

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

a container configured to store discarded biohazardous material, wherein the sample cell is configured to receive at least a portion of the biological fluid sample through the sample supply passage; and

an user interface configured to display the determined level of the at least one analyte.

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 user interface comprises a display device.

7. The system of claim 6, further comprising a display controller configured to control the display device.

8. The system of claim 1, wherein the analyte detection system comprises an electronic signal processor configured to determine the level of the at least one analyte in the biological fluid sample and communicate the determined level to the user interface.

9. The system of claim 1, wherein the user interface is configured to display an estimate of the accuracy of the determined level of the at least one analyte in the biological fluid sample.

10. The system of claim 1, wherein the user interface is configured to receive an input from the user.

11. 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.