Method and apparatus for monitoring intravenous (IV) drug concentration using exhaled breath

• US 7,104,963 B2
• Filed: 01/22/2002
• Issued: 09/12/2006
• Est. Priority Date: 01/22/2002
• Status: Expired due to Term

• Current Assignee: University of Florida Research Foundation, Incorporated (State University System of Florida)
• Original Assignee: University of Florida Research Foundation, Incorporated (State University System of Florida)
• Inventors: Melker, Richard J., Bjoraker, David G.
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US10/054,619
• Publication Number:
  US 20030139681A1
• Time in Patent Office: 1,694 Days
• Field of Search: 600/529, 600/531, 600/532, 600/533, 600/538, 73/233, 128/203.12, 128/203.13
• US Class Current: 600/532
• 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 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00

Abstract

A method and system is provided for detecting the depth of anesthesia wherein at least one anesthetic agent is absorbed in a patient'"'"'s bloodstream during the administration of anesthesia, which includes sampling a patient'"'"'s expired breath; analyzing the breath for concentration of at least one substance indicative of the anesthetic agent using sensor technology such as free (unmetabolized) anesthetic agent or its metabolites; determining the effect of the agent based on that concentration; and determining depth of anesthesia based thereon. The method also detects endogenous compounds such as ketones and ammonia in exhaled breath as well as other pathologic organisms.

Claims

1. A method for determining the blood level concentration of at least one agent selected from the group consisting of anesthetics, analgesics, muscle relaxants, sedatives, and anxiolytics, wherein the agent is administered into a patient'"'"'s bloodstream, comprising:

sampling a patient'"'"'s expired breath;

analyzing the breath for concentration of at least one substance indicative of the agent using sensor technology;

determining at least one blood level concentration based on the concentration of at least one substrance indicative of the at least one agent; and

using a flow sensor to detect starting and completion of exhalation during said sampling step.

2. The method of claim 1 wherein the breath is analyzed after a predetermined period of time.

3. The method of claim 1 further comprising the step of controlling an infusion pump for delivering the agent intravenously based on the determined blood level concentration.

4. The method of claim 1 wherein the agent is delivered by a delivery method selected from the group comprising:

intravenous continuous delivery, parenteral delivery, sublingual delivery, transdermal delivery, and intravenous bolus delivery.

5. The method of claim 1 wherein the agent is delivered by continuous infusion.

6. The method of claim 1 wherein the agent is delivered by an infusion pump.

7. The method of claim 1 wherein the agent is selected from the group comprising Remifentanil and Propofol.

8. The method of claim 1 wherein the steps are repeated periodically to monitor trending over time.

9. The method of claim 1 wherein the agent is for amnesia.

10. The method of claim 1 wherein the agent is for analgesia.

11. The method of claim 1 wherein the agent is for muscle relaxation.

12. The method of claim 1 wherein the agent is for sedation.

13. The method of claim 1 wherein a combination of agents is administered.

14. The method of claim 1 wherein the determined blood level concentration is measured to determine anesthetic blood concentration.

15. The method of claim 1 wherein the determined blood level concentration is measured to determine analgesic blood concentration.

16. The method of claim 1 wherein the determined blood level concentration is measured for alevel indicative of recovery.

17. The method of claim 1 wherein the sampling is continuous.

18. The method of claim 1 wherein the sampling is periodic.

19. The method of claim 1 wherein the patient'"'"'s breath is analyzed by sensor technology selected from semiconductor gas sensor technology, conductive polymer gas sensor technology, or surface acoustic wave gas sensor technology.

20. The method of claim 19 wherein the sensor technology produces a unique electronic fingerprint to characterize the concentration of said at least one substance.

21. The method of claim 1 further comprising the step of recording data resulting from analysis of the patient'"'"'s breath.

22. The method of claim 1 further comprising the step of transmitting data resulting from analysis of the patient'"'"'s breath.

23. The method of claim 1 wherein the analysis of the patient'"'"'s breath includes comparing the substance sensed in the patient'"'"'s breath with a predetermined signature profile.

24. The method of claim 1 further comprising the step of capturing the patient'"'"'s breath in a vessel prior to analysis.

25. The method of claim 1 further comprising the step of dehumidifying the patient'"'"'s breath prior to analyzing.

26. The method of claim 1 wherein said analysis further includes detecting exhalation of the patient'"'"'s breath with a sensor.

27. The method of claim 1 wherein said substance indicative of the agent is free agent.

28. The method of claim 1 wherein said substance indicative of the agent is metabolites of the agent.

29. The method of claim 1 wherein said substance indicative of the agent is free agent and metabolites of the agent.

30. The method of claim 1 further comprising the step of assigning a numerical value to the concentration of at least one substance indicative of the agent as analyzed upon reaching a level of pharmacological effect in said patient and, thereafter, assigning higher or lower values to the concentration based on its relative changes.

31. The method of claim 30 further comprising monitoring the concentration of at least one substance indicative of the agent by monitoring changes in said value and adjusting administration of said agent to maintain a desired pharmacological effect.

32. An apparatus for administering intravenous anesthesia to a patient comprising:

at least one supply of at least one intravenous anesthesia agent;

intravenous delivery means for controllably intravenously delivering said at least one intravenous anesthesia agent to the patent;

a breath analyzer for analyzing the patient'"'"'s breath for concentration of at least one substance indicative of the anesthetic agent in the patient'"'"'s bloodstream and providing a signal to indicate the anesthetic agent concentration delivered to the patient; and

a system controller connected to the intravenous delivery means which receives the signal and controls the amount of anesthetic agent based on the signal.

33. A method for monitoring perflubron levels in an anemic patient, comprising:

(i) sampling a patient'"'"'s breath;

(ii) analyzing the breath for concentration of perflubron using sensor technology; and

(iii) calculating the blood concentration of perflubron based on the concentration.