Detecting Cross-contamination in Blood Measurements with a Multilumen Catheter

• US 20090048535A1
• Filed: 09/25/2007
• Published: 02/19/2009
• Est. Priority Date: 08/13/2007
• Status: Abandoned Application

• Current Assignee: Luminous Medical, Inc.
• Original Assignee: Luminous Medical, Inc.
• Inventors: Borrello, Mike, Robinson, Mark Ries, Thompson, Richard, O'Mahony, John, Grafe, V. Gerald
• Application Number:
  US11/860,545
• Publication Number:
  US 20090048535A1
• Time in Patent Office: Days
• US Class Current: 600/581
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/150961 Means for the detection of the presence or absence of a module, a component or an abnormal condition; detection of leaks
• 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

Abstract

The present invention comprises methods and apparatuses that can provide accurate measurement of glucose or other analytes from a multilumen catheter in the presence of infusion of substances, including glucose. Examples of “multilumen catheters” include central venous catheters having multiple lumens, midline catheters having multiple lumens, multiple catheters configured or emplaced such that their lumens are in proximity to each other, and, in the case of indwelling analyte sensors, a catheter with a lumen for infusion and an indwelling sensor spaced apart from the infusion lumen. For blood withdrawal, anti-cross contamination controls can prevent the entrainment of blood which might be contaminated with feeding fluids or medications that are administered through other lumens within the catheter and in proximity of the blood sampling port. Cross contamination can occur under various situations, and is known to occur when the patient is connected to a ventilator. The ventilator cyclically raises the intra-thoracic pressure and diminishes blood flow rate in the central veins returning to the heart. The diminished flow can increase the chances for cross-contamination when additional lumens are introducing fluids during a draw sample.

Claims

1. A method for determining whether a measured value of a target analyte in blood measured at a first location is likely to be contaminated with an infusate infused at a second location, comprising comparing an indicator characteristic of the blood determined at a first time with the indicator characteristic of the blood determined at a second time, and evaluating the comparison against a metric.

2. A method as in claim 1, wherein the first and second times are during patient conditions similar to the patient conditions under which the target analyte is measured.

3. A method as in claim 1, wherein the metric reflects expected change in the indicator characteristic due only to physiological changes.

4. A method as in claim 1, wherein the indicator characteristic does not substantially change due to physiological processes but does change substantially in the presence of the infusate.

9. A method as in claim 1, wherein the indicator characteristic comprises measurement of the target analyte.

10. A method as in claim 9, wherein the target analyte is glucose.

13. A method as in claim 1, wherein the indicator characteristic comprises measurement of a substance present in the infusate at a different concentration than in the blood.

15. A method as in claim 1, wherein the indicator characteristic comprises measurement of a substance not present in the infusate.

17. A method as in claim 13, wherein the substance is chosen from the group consisting of potassium, hemoglobin, albumin, triglycerides, serum proteins, or a combination thereof.

19. A method as in claim 1, wherein the indicator characteristic is chosen from the group consisting of optical scatter, electrical conductivity, absorbance spectrum, or a combination thereof.

21. A method as in claim 1, wherein the patient is subject to mechanical ventilation, and the metric comprises a determination of whether the indicator characteristic changes in a manner correlated with the mechanical ventilation.

23. A method for measuring a target analyte in blood of a patient, comprising determining whether a measured value is likely to be contaminated according to the method of claim 1, and, if not, then measuring the target analyte in the blood and reporting the value.

25. A method as in claim 23, wherein measuring the value of the target analyte comprises measuring the target analyte concentration in blood from the response of the blood to incident light.

27. A method for measuring a target analyte in blood of a patient, comprising determining whether a measured value is likely to be contaminated according to the method of claim 1, and measuring the target analyte in the blood wherein the measurement is adjusted based on the indicator characteristic.

5. A method of determining whether patient conditions are likely to lead to contamination of a target blood analyte with an infusate, comprising comparing an indicator characteristic of the blood determined at a first time with the indicator characteristic of the blood determined at a second time, and evaluating the comparison against a metric.

6. A method as in claim 5, wherein the first and second times are during patient conditions similar to the patient conditions under which the target analyte is measured.

7. A method as in claim 5, wherein the metric reflects expected change in the indicator characteristic due only to physiological changes.

8. A method as in claim 5, wherein the indicator characteristic does not substantially change due to physiological processes but does change substantially in the presence of the infusate.

11. A method as in claim 5, wherein the indicator characteristic comprises measurement of the target analyte.

12. A method as in claim 11, wherein the target analyte is glucose.

14. A method as in claim 5, wherein the indicator characteristic comprises measurement of a substance present in the infusate at a different concentration than in the blood.

16. A method as in claim 5, wherein the indicator characteristic comprises measurement of a substance not present in the infusate.

18. A method as in claim 14, wherein the substance is chosen from the group consisting of potassium, hemoglobin, albumin, triglycerides, serum proteins, or a combination thereof.

20. A method as in claim 5, wherein the indicator characteristic is chosen from the group consisting of optical scatter, electrical conductivity, absorbance spectrum, or a combination thereof.

22. A method as in claim 5, wherein the patient is subject to mechanical ventilation, and the metric comprises a determination of whether the indicator characteristic changes in a manner correlated with the mechanical ventilation.

24. A method for measuring a target analyte in a blood sample withdrawn from a patient, comprising withdrawing the blood sample, evaluating the blood sample for likely contamination according to the method of claim 5, and measuring and reporting the value of the target analyte if the evaluation indicates that contamination is unlikely.

26. A method as in claim 24, wherein measuring the value of the target analyte comprises creating a portion of the blood sample having substantially no red blood cells, and measuring the target analyte concentration in the portion created.