Systems and methods for determining physiological parameters using measured analyte values

• US 8,412,293 B2
• Filed: 07/16/2008
• Issued: 04/02/2013
• Est. Priority Date: 07/16/2007
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Rule, Peter
• Primary Examiner(s): VIVLEMORE, TRACY ANN
• Application Number:
  US12/174,501
• Publication Number:
  US 20090043171A1
• Time in Patent Office: 1,721 Days
• Field of Search: None
• US Class Current: 600/310
• 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 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 by irradiating the fluid sample with electromagnetic radiation having a wavelength in the range between approximately 600 nm and 12 μ

m, the analyte detection system further configured to irradiate in the lower near-infrared portion of the range and irradiate separately in the higher, mid-infrared portion of the range;

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.

2. The system of claim 1, wherein the analyte detection system further comprises a fluid handling system configured to draw the fluid sample from the patient.

3. The system of claim 2, wherein the fluid sample comprises blood.

4. The system of claim 1 wherein the medical sensor comprises a pulse oximeter.

5. The system of claim 1 further comprising a user interface configured to allow input of patient data.

6. The system of claim 5 wherein the patient data includes one or more of a patient'"'"'s height, weight, age, and gender.

7. The system of claim 1 further comprising a data storage device configured to store at least one of the first analyte data and the second analyte data.

8. The system of claim 7, wherein the processor is configured to determine the physiological parameter based at least in part on information determined from the stored analyte data.

9. The system of claim 8, 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.

10. The system of claim 1 wherein the medical sensor is physically remote from the analyte detection system.

11. The system of claim 1 wherein the processor is configured to receive at least one of the first analyte value and the second analyte value via wireless techniques.

12. The system of claim 1 wherein the processor is configured to receive at least one of the first analyte value and the second analyte value via a network.

13. The system of claim 12, wherein the network comprises a hospital information system.

14. The system of claim 1 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.

15. The system of claim 14, wherein the cardiovascular parameter comprises cardiac output.

16. The system of claim 15, 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.

17. The system of claim 1, wherein the medical sensor is configured to measure second analyte data in the patient by irradiating the sample with near-infrared radiation.

18. The system of claim 17, wherein the analyte detection system includes the medical sensor, and the system is configured to measure the first analyte in the mid-infrared range and the medical sensor is configured to measure the second analyte in the near-infrared range.

19. The system of claim 1, wherein one of the near-infrared portion or the mid-infrared portion is used for calibration of the analyte detection system and the other of the near-infrared portion or the mid-infrared portion is used to measure the first analyte data.

20. The system of claim 1, wherein one of the near-infrared portion or the mid-infrared portion is used to detect the arrival of the sample in the analyte detection system.

21. The system of claim 1, wherein one of the near-infrared portion or the mid-infrared portion is used to determine interferents present in the sample.

22. 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 by irradiating the fluid sample by an electromagnetic radiation having wavelength in the range between approximately 600 nm and 12 μ

m;

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.

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

an analyte detection system configured to measure a first analyte in a fluid sample received from a patient by irradiating the fluid sample by an electromagnetic radiation having wavelength in the mid-infrared range and a second analyte by irradiating the fluid sample with electromagnetic radiation having wavelength in the near-infrared range; 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.

24. The system of claim 23, wherein the analyte detection system comprises a medical sensor configured to measure the second analyte, the medical sensor located remotely from the analyte detection system.

25. The system of claim 23, wherein the analyte detection system further comprises a fluid handling system configured to draw the fluid sample from the patient.

26. The system of claim 25, wherein the fluid handling system comprises:

a fluid passageway adapted to be connected to the patient;

at least one pump configured to withdraw body fluid from the patient; and

at least one fluid control element configured to isolate the fluid sample from the withdrawn body fluid and direct the sample portion to a sample analysis chamber.

27. The system of claim 25, wherein the fluid handling system is configured to return a portion of the withdrawn body fluid that is not directed toward the sample analysis chamber to the patient.

28. The system of claim 23, wherein the fluid sample includes whole blood or plasma.