APPARATUS AND METHOD FOR THE DETERMINATION OF SEPSIS RISK USING COMPONENTS OF EXHALED BREATH

• US 20190317074A1
• Filed: 04/11/2019
• Published: 10/17/2019
• Est. Priority Date: 04/13/2018
• Status: Abandoned Application

• Current Assignee: Vail Scientific, LLC
• Original Assignee: Vail Scientific, LLC
• Inventors: Anderson, Carter R., Morris, Russell L., Burke, Thomas W., Anderson, Clayton J.
• Application Number:
  US16/381,960
• Publication Number:
  US 20190317074A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: G01N 33/0037 NOx
• CPC Class Codes: G01N 33/497 of gaseous biological material, e.g. breath
• CPC Class Codes: G01N 33/4975 other than oxygen, carbon dioxide or alcohol, e.g. organic vapours
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: Y02A 50/20 Air quality improvement or preservation, e.g. vehicle emission control or emission reduction by using catalytic converters

Abstract

Disclosed herein are methods and devices for measurement of carbon dioxide and nitric oxide in exhaled breath of patients at risk for or suffering from sepsis. Carbon dioxide and nitric oxide levels may be measured in controlled rate breath and/or end tidal breath, and a risk score for the patient developing or having sepsis may be determined. In many embodiments, carbon dioxide and nitric oxide measurements are determined simultaneously in a single breath, and by a single measurement apparatus, while other embodiments measure nitric oxide and carbon dioxide levels using separate measure apparatuses and/or in different breaths of the patient.

Claims

1. A sepsis assessment device comprising:

a fluid input in fluid communication with a respiratory tract of a patient, wherein the fluid input receives an exhaled breath from the patient;

a NO measurement device that determines a NO concentration in the exhaled breath;

a CO₂ measurement device that determines a CO₂ concentration in the exhaled breath;

an input/output interface;

a processing element in electrical communication with the CO₂ and NO measurement devices and the input/output interface, wherein the processing element receives a first signal corresponding to the NO concentration;

receives a second signal corresponding to the CO₂ concentration;

determines a sepsis risk score based on the first signal and the second signal; and

transmits the sepsis risk score to the input/output interface.

2. The device of claim 1, wherein the NO measurement device measures one of controlled rate NO and end-tidal NO.

3. The device of claim 1, wherein the CO₂ measurement device measures one of controlled rate CO₂ and end-tidal CO₂.

4. The device of claim 1, wherein the NO measurement device and the CO₂ measurement device are the same device that can measure both NO and CO₂.

5. The device of claim 1, wherein the determination of the sepsis risk score includes comparing the NO concentration and the CO₂ concentration against a database of information for previous patients having similar nitric oxide and carbon dioxide levels.

6. The device of claim 5, wherein the processing element uses information from the database to improve accuracy of the sepsis risk score.

7. A method for determining the risk of sepsis in a patient comprising:

collecting an exhaled breath sample;

regulating the flow rate of the exhaled breath sample;

determining a CO₂ concentration in the exhaled breath sample;

determining a NO concentration in the exhaled breath sample;

correlating the NO concentration and the CO₂ concentration to a sepsis risk score;

developing a treatment regime for the patient that is based on the sepsis risk score.

8. The method of claim 7, wherein the CO₂ concentration is obtained by a controlled rate measurement and the NO concentration is obtained by a controlled rate measurement.

9. The method of claim 7, wherein the CO₂ concentration is obtained by an end tidal measurement and the NO concentration is obtained by an end tidal measurement.

10. The method of claim 7, wherein the CO₂ concentration is obtained by a controlled rate measurement and the NO concentration is obtained by an end tidal measurement.

11. The method of claim 7, wherein the CO₂ concentration is obtained by an end tidal measurement and the NO concentration is obtained by a controlled rate measurement.

12. The method of claim 7, wherein the sepsis risk score is used to diagnose sepsis in the patient.

13. The method of claim 7, wherein exhaled breath concentrations of CO₂ below 25 mmHg and exhaled breath concentrations of NO above 25 ppb are indicative of sepsis risk greater than about 10%.

14. The method of claim 7, wherein exhaled breath concentrations of CO₂ below 25 mmHg, and exhaled breath concentrations of NO above 40 ppb are indicative of sepsis risk greater than about 10%.

15. The method of claim 7, wherein the sepsis risk score is based on a comparison of NO and CO₂ readings against a database of NO and CO₂ readings and scores for previous patients having similar NO and CO₂ levels.

16. The method of claim 15, wherein the previous patient is the same patient, and the readings include a trend over time.

17. The method of claim 15, wherein a processing element uses information from the database to improve accuracy of the sepsis risk score.

18. The method of claim 15, wherein the database is contained within a sepsis assessment device.

19. The method of claim 15, wherein the database is remotely accessed from a sepsis assessment device.