Analyte monitoring systems and methods

• US 10,499,841 B2
• Filed: 03/01/2018
• Issued: 12/10/2019
• 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:
  US15/909,572
• Publication Number:
  US 20180317828A1
• Time in Patent Office: 649 Days
• Field of Search: 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 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 from a patient and into the analyte detection system; and

a sample element forming part of the analyte detection system, the sample element comprising;

a sample cell configured to hold at least one component of the biological fluid sample;

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

a filter disposed in the sample supply passage configured to filter out the at least one component of the sample of bodily fluid;

wherein the sample cell is configured to receive at least a portion of the biological fluid sample through the sample supply passage.

2. The system of claim 1, wherein the filter comprises a membrane.

3. The system of claim 2, wherein the membrane is configured to facilitate a flow of the analyte therethrough.

4. The system of claim 3, wherein the sample element is configured to facilitate a flow of the biological fluid sample substantially transverse to a direction of the diffusion of the analyte through the at least one membrane.

5. The system of claim 4 wherein the system is configured to drive a flow of the biological fluid sample from a first opening to a second opening of the sample element.

6. The system of claim 1, wherein the at least one component of the sample of bodily fluid comprises hemoglobin.

7. The system of claim 1, wherein the biological fluid sample comprises whole blood.

8. The system of claim 1, wherein the sample element is disposable after use.

9. The system of claim 1, wherein the analyte detection system is configured to use a transmission of energy in or through the sample cell and a measurement thereof to determine the level of the analyte present in the at least one component of the biological fluid sample.

10. The system of claim 9, wherein an optical source provides the transmission of energy into the sample cell and an optical sensor measures at least one of the resulting reflection, transmission, or refraction of the energy after it has interacted with a sample in the sample cell, such that information gathered by the optical sensors contains data relating to the level of the analyte present in the at least one component of the biological fluid sample.

11. The system of claim 9, wherein an electrochemical source provides a transmission of energy in the sample cell and an electrical sensor measures at least one of the resulting voltage, current, or resistance of the electrical energy associated with the sample, such that information gathered by the electrical sensor contains data relating to the level of the analyte present in the at least one component of the biological fluid sample.

12. The system of claim 1, wherein the filter uses either wicking or capillary action, or both, to transport the biological fluid sample through the sample supply passage to the sample cell.

13. The system of claim 1, wherein the sample element further comprises an air vent passage configured to improve capillary action within the sample supply passage.

14. The system of claim 13, wherein the sample cell is positioned between the sample supply passage and the air vent passage.

15. The system of claim 1, wherein the sample element further comprises an opening at the end of the sample supply passage opposite the sample cell, and wherein the biological fluid sample flows into the sample supply passage via the opening.

16. The system of claim 1, wherein a thickness of the sample supply passage is between about 1 μ

m and about 1.22 mm.

17. The system of claim 1, wherein the sample supply passage comprises one or more ridges formed on an inner surface of the sample supply passage, and wherein shape of the ridges enhances flow of the biological fluid sample into the sample supply passage.

18. The system of claim 1, wherein the sample supply passage comprises a pierceable portion, and wherein the sample extractor pierces the pierceable portion of the sample supply passage to provide an inlet for the biological fluid sample to enter the sample supply passage.

19. The system of claim 1, wherein the sample cell is configured to facilitate a plurality of determinations of analyte level in one or more portions of the biological fluid sample by the analyte detection system.

20. The system of claim 1, wherein the sample element further comprises a flow portion comprising one or more pores dimensioned to draw the biological fluid sample therein and a filter portion configured to reduce flow of the biological fluid sample for determination of the level of analyte therein.