Analyte detection systems and methods using multiple measurements

• US 9,913,604 B2
• Filed: 11/30/2015
• Issued: 03/13/2018
• Est. Priority Date: 02/14/2005
• Status: Expired due to Fees

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Braig, James R., Rule, Peter
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US14/954,869
• Publication Number:
  US 20160157768A1
• Time in Patent Office: 834 Days
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2230/20 : Blood composition characteristics
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 5/14212 : Pumping with an aspiration and an expulsion action
• CPC Class Codes: A61M 5/14232 : Roller pumps
• CPC Class Codes: A61M 5/16854 : by monitoring line pressure
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/365 : Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626
• CPC Class Codes: A61M 5/38 : using hydrophilic or hydrophobic filters
• CPC Class Codes: G01N 21/274 : Calibration, base line adjustment, drift correction
• CPC Class Codes: G01N 21/35 : using infrared light G01N21/39 takes precedence
• CPC Class Codes: G01N 2201/1293 : resolving multicomponent spectra
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection

Abstract

In certain embodiments, a sampling assembly is for use with a main analyzer. The main analyzer is configured to sense an analyte in a body fluid obtained from a patient through a first fluid passageway extending from the main analyzer. The sampling assembly includes an instrument portion separate from the main analyzer and including at least one sensor. The instrument portion is removably engaged with the first fluid passageway. The at least one sensor is in sensing engagement with the first fluid passageway such that the at least one sensor can sense a property of a fluid within the first fluid passageway.

Claims

1. An apparatus for analyzing bodily fluid, the apparatus comprising:

a fluid handling network comprising;

a patient connector configured to maintain fluid communication with the bodily fluid in a patient; and

at least one passageway configured to connect between the patient connector and a sample analysis chamber;

at least one pump in operative engagement with the fluid handling network, the at least one pump having a sample draw mode in which the at least one pump is operable to draw a sample of the bodily fluid from the patient through the at least one passageway, wherein the at least one pump is configured to direct an analysis portion of the sample to the sample analysis chamber;

an analyzer configured to obtain at least one mid-infrared spectroscopic characterization of the analysis portion of the sample while the sample is located inside the sample analysis chamber;

a waste chamber configured to receive the analysis portion from the sample analysis chamber after the analysis portion is analyzed by the analyzer; and

a fluid sensor located between the patient connector and a first fluid junction of the fluid handling network and spaced from the sample analysis chamber, the fluid sensor configured to sense a property of the bodily fluid within the at least one passageway while the bodily fluid is located outside of the sample analysis chamber and wherein the analyzer is configured to determine whether the bodily fluid within the at least one passageway contains a minimum threshold of optical density over a minimum amount of time.

2. The apparatus of claim 1, wherein the minimum threshold of optical density comprises a minimum threshold of optical absorption.

3. The apparatus of claim 1, wherein the minimum amount of time comprises an amount of time sufficient to indicate a presence of undiluted blood.

4. The apparatus of claim 1, wherein the fluid sensor is further configured to sense a property of the return portion of the sample.

5. The apparatus of claim 1, further comprising a controller configured to operate the at least one pump in the sample draw mode at intervals.

6. The apparatus of claim 5, wherein the intervals are irregular.

7. The apparatus of claim 1, wherein the fluid sensor is located at or near a patient end of the fluid handling network.

8. The apparatus of claim 1, wherein the fluid sensor comprises a colorimetric sensor, a pressure sensor, a bubble sensor, a dilution sensor, or a combination of sensors.

9. The apparatus of claim 1, wherein the analyzer is configured to use the mid-infrared spectroscopic characterization to estimate a level of at least one analyte.

10. The apparatus of claim 9, wherein the at least one analyte is glucose.

11. The apparatus of claim 1, wherein the analyzer comprises a mid-infrared source configured to emit infrared radiation at wavelengths between about 1.5 μ

m and about 11 μ

m.

12. The apparatus of claim 11, wherein the mid-infrared source is configured to emit infrared wavelengths between 4 μ

m and 11 μ

m.

13. The apparatus of claim 1, wherein the analyzer comprises at least one optical filter.

14. A method for analyzing a bodily fluid, the method comprising:

drawing the bodily fluid from a patient and into a fluid handling apparatus that comprises a sample chamber, wherein the fluid handling apparatus is configured to maintain physical connectivity with the patient through a patient connector;

analyzing at least one portion of the bodily fluid using a fluid sensor that is positioned to analyze the at least one portion while the at least one portion is located inside the fluid handling apparatus but outside of the sample chamber between the patient connector and a first fluid junction of the fluid handing apparatus, wherein the fluid sensor detects a minimum optical threshold over a minimum amount of time;

directing at least an analysis portion of the bodily fluid to the sample chamber; and

analyzing the analysis portion of the bodily fluid inside the sample chamber by obtaining at least one spectroscopic measurement.

15. The method of claim 14, further comprising delivering the analysis portion to a waste receptacle after analyzing the analysis portion of the bodily fluid inside the sample chamber by obtaining at least one spectroscopic measurement.

16. The method of claim 14, wherein the at least one portion of the bodily fluid which is analyzed by the fluid sensor is undiluted.

17. The method of claim 14, wherein obtaining the at least one spectroscopic measurement comprises analyzing the analysis portion with infrared wavelengths.

18. The method of claim 17, wherein obtaining the at least one spectroscopic measurement comprises analyzing the analysis portion with mid-infrared wavelengths.

19. The method of claim 18, wherein the mid-infrared wavelengths have wavelengths between 1.5 μ

m and 11 μ

m.

20. The method of claim 14, wherein drawing the bodily fluid comprises drawing the bodily fluid from the patient at regular or irregular intervals.