Systems And Methods For Determining Physiological Parameters Using Measured Analyte Values

• US 20090043171A1
• Filed: 07/16/2008
• Published: 02/12/2009
• Est. Priority Date: 07/16/2007
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Rule, Peter
• Granted Patent: US 8,412,293 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• 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 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• 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 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61M 2005/1404 Keep vein-open rate [KVO], i.e. low flow rate
• CPC Class Codes: G01N 21/359 using near infrared light

Abstract

Systems and methods for determining a physiological parameter in a patient are provided. In certain embodiments, a system can include an analyte detection system configured to measure first analyte data in a fluid sample received from a patient, a medical sensor configured to measure second analyte data in the patient, and a processor configured to receive the first analyte data and the second analyte data and to determine a physiological parameter based at least in part on the first analyte data and the second analyte data. In certain such embodiments, the medical sensor may be a pulse oximeter, and the physiological parameter may include a cardiovascular parameter including, for example, cardiac output.

Claims

1. A method for determining a physiological parameter in a patient, the method comprising:

receiving, in a first analyte detection system, a fluid sample from a patient;

measuring, by the first analyte detection system, one or more analyte values in the fluid sample;

measuring, by a second analyte detection system, one or more analyte values in the patient;

determining a physiological parameter in the patient based at least in part on the one or more analyte values measured by the first analyte detection system and the one or more analyte values measured by the second analyte detection system.

2. The method of claim 1, wherein the first analyte detection system comprises a fluid handling system configured to transport the received fluid sample.

3. The method of claim 2, further comprising drawing the fluid sample from the patient with the fluid handling system.

4. The method of claim 1, wherein the fluid sample comprises blood.

5. The method of claim 1 wherein measuring, by the first analyte detection system, comprises measuring at least one of an oxygen saturation in the fluid sample and a hemoglobin concentration in the fluid sample.

6. The method of claim 1 wherein the second analyte detection system is physically remote from the first analyte detection system.

7. The method of claim 1, wherein the second analyte detection system comprises a pulse oximeter.

8. The method of claim 7, wherein measuring, by the second analyte detection system, comprises measuring at least one of an oxygen saturation and a pulse rate.

9. The method of claim 1 where the physiological parameter comprises a cardiovascular parameter.

10. The method of claim 9, wherein the cardiovascular parameter comprises cardiac output.

11. The method of claim 1 further comprising receiving patient data and wherein the determining is based at least in part on the patient data.

12. The method of claim 11, wherein the patient data comprises data related to one or more of the patient'"'"'s height, weight, age, and gender.

13. The method of claim 12, wherein determining comprises using a computer system to calculate the patient'"'"'s cardiac output Q based at least in part on the formula:

Q=VO2/(K*Hb *(SaO2−

SvO2)),

where

VO2 is the patient'"'"'s consumption rate of oxygen determined at least in part on the patient data;

K is a Hufner number relating amount of oxygen carried by saturated hemoglobin;

Hb is the patient'"'"'s hemoglobin concentration in a venous fluid sample;

SvO2 is the patient'"'"'s oxygen saturation in a venous fluid sample; and

SaO2 is the patient'"'"'s arterial oxygen saturation measured by the second analyte detection system.

14. A system for determining a physiological parameter in a patient, the system comprising:

an analyte detection system configured to measure first analyte data in a fluid sample received from a patient;

a medical sensor configured to measure second analyte data in the patient; and

a processor configured to receive the first analyte data and the second analyte data and to determine a physiological parameter based at least in part on the first analyte data and the second analyte data.

15. The system of claim 14, wherein the analyte detection system further comprises a fluid handling system configured to draw the fluid sample from the patient.

16. The system of claim 15, wherein the fluid sample comprises blood.

17. The system of claim 14 wherein the medical sensor comprises a pulse oximeter.

18. The system of claim 14 further comprising a user interface configured to allow input of patient data.

19. The system of claim 18 wherein the patient data includes one or more of a patient'"'"'s height, weight, age, and gender.

20. The system of claim 14 further comprising a data storage device configured to store at least one of the first analyte data and the second analyte data.

21. The system of claim 20, wherein the processor is configured to determine the physiological parameter based at least in part on information determined from the stored analyte data.

22. The system of claim 21, wherein the processor is configured to use the stored analyte data to provide an estimated analyte value, where the estimation comprises at least one of interpolation, extrapolation, averaging, filtering, and correlation.

23. The system of claim 14 wherein the medical sensor is physically remote from the analyte detection system.

24. The system of claim 14 wherein the processor is configured to receive at least one of the first analyte value and the second analyte value via wireless techniques.

25. The system of claim 14 wherein the processor is configured to receive at least one of the first analyte value and the second analyte value via a network.

26. The system of claim 25, wherein the network comprises a hospital information system.

27. The system of claim 14 wherein the first analyte data comprise a value for venous oxygen saturation and a value for venous hemoglobin concentration, the second analyte data comprise a value for arterial oxygen saturation, and the physiological parameter comprises a cardiovascular parameter.

28. The system of claim 27, wherein the cardiovascular parameter comprises cardiac output.

29. The system of claim 28, wherein the processor is configured to determine the cardiac output based at least in part on the formula:

Q=VO2/(K*Hb *(SaO2−

SvO2)),

where

Q is the cardiac output;

VO2 is a consumption rate of oxygen determined at least in part on patient data received by the processor;

K is a Hufner number relating amount of oxygen carried by saturated hemoglobin;

Hb is the venous hemoglobin concentration;

SvO2 is the venous oxygen saturation; and

SaO2 is the arterial oxygen saturation.