System and method for monitoring health using exhaled breath

• US 8,211,035 B2
• Filed: 08/29/2006
• Issued: 07/03/2012
• Est. Priority Date: 01/22/2002
• Status: Expired due to Fees

• 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., Lampotang, Samsun
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US11/512,856
• Publication Number:
  US 20070203448A1
• Time in Patent Office: 2,135 Days
• Field of Search: 600529-543, 600/484, 600/483, 600/481, 128/203.12, 128/203.14, 128/204.23, 128/204.18, 604/512
• 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 5/14532 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 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence
• CPC Class Codes: A61B 5/7267 involving training the classification device
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/01 specially adapted for anaesthetising A61M16/104, A61M16/18 take precedence
• CPC Class Codes: A61M 16/026 specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
• CPC Class Codes: A61M 16/0808 Condensation traps
• CPC Class Codes: A61M 16/0841 for sampling
• CPC Class Codes: A61M 16/1045 Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas
• CPC Class Codes: A61M 16/18 Vaporising devices for anaesthetic preparations
• CPC Class Codes: A61M 16/22 Carbon dioxide-absorbing devices ; Other means for removing carbon dioxidecartridges with absorbing substances for respiratory apparatus A62B19/00
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/1035 the anaesthetic agent concentration
• CPC Class Codes: A61M 2202/0275 Nitric oxide [NO]
• CPC Class Codes: A61M 2202/0486 Glucose
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/80 : voice-operated command
• CPC Class Codes: A61M 2230/43 : Composition of exhalation
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)
• CPC Class Codes: A61M 2230/435 : partial O2 pressure (P-O2)
• CPC Class Codes: A61M 2230/437 : the anaesthetic agent concentration
• CPC Class Codes: G01N 33/497 : of gaseous biological material, e.g. breath
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 : for local operation

Abstract

The present invention includes systems and methods for monitoring endogenous compound concentration in blood by detecting markers, such as odors, upon exhalation by a patient, wherein such markers are the endogenous compound itself or result from the endogenous compound. In the case of olfactory markers, the invention preferably utilizes electronic sensor technology, such as the commercial devices referred to as “artificial” or “electronic” noses or tongues, to non-invasively monitor endogenous compound levels in blood. The invention further includes a reporting system capable of tracking endogenous compound concentrations in blood (remote or proximate locations) and providing the necessary alerts with regard to emergent or harmful conditions in a patient.

Claims

1. An anesthetic agent delivery system or apparatus for intravenously delivering a desired dose of anesthetic agent to a patient comprising:

(a) an intravenous anesthetic supply;

(b) a breath analyzer for analyzing the patient'"'"'s breath for concentration of at least one substance, selected from the group consisting of the active anesthetic agent itself or a metabolite thereof, indicative of the anesthetic agent concentration in the patient'"'"'s bloodstream, and for providing a signal to indicate the anesthetic agent concentration delivered to the patient; and

(c) a system controller connected to the anesthetic supply which receives the signal and controls the amount of anesthetic agent based on the signal.

2. The system or apparatus of claim 1 wherein the breath analyzer comprises a collector for sampling the patient'"'"'s expired breath, a sensor for analyzing the breath for concentration of at least one substance indicative of the anesthetic agent concentration, a processor for calculating the effect of the agent based on the concentration and determining depth of anesthesia.

3. The system or apparatus of claim 2 wherein the sensor is selected from semiconductor gas sensor technology, surface acoustic wave gas sensor technology or conductive polymer gas sensor technology.

4. The system or apparatus of claim 1, further comprising respiratory phase sensor technology for determining a specific phase of the respiratory cycle from which the sample of breath is collected.

5. The system or apparatus of claim 4, wherein said respiratory phase sensor technology is selected from the group consisting of:

viscosity sensors;

flow sensors;

pressure sensors;

humidity sensors;

temperature sensors; and

gas sensors.

6. The system or apparatus of claim 5, wherein said respiratory phase sensor technology is selected from the group consisting of:

CO₂ sensors;

O₂ sensors; and

NO sensors.

7. The system or apparatus of claim 4, wherein the sample of breath is collected from the initial phase or end-tidal phase.

8. The system or apparatus according to claim 1 wherein said anesthetic agent supply comprises an anesthetic gas supply in addition to said intravenous agent supply.

9. The system or apparatus according to claim 8 comprising both an anesthetic gas supply and an intravenous agent supply, and wherein said controller controls the amount of anesthetic gas supply to a breathing circuit including said patient, said controller controls the amount of intravenous agent administered to the patient intravenously, or both, or wherein separate controllers control the amount of said anesthetic gas supply to a breathing circuit including said patient and the amount of intravenous agent administered to the patient intravenously.

10. The system or apparatus according to claim 8 further comprising an inspired gas analyzer for analyzing the concentration of anesthetic gas in the breathing circuit.

11. The system or apparatus according to claim 10 wherein said controller is connected to both an intravenous anesthetic supply and an anesthetic gas supply and which receives signals from both an inspired gas analyzer and an expired gas analyzer and controls the amount of anesthetic agents administered based on the signals or wherein a first controller receives a signal from an inspired gas analyzer and a second controller receives a signal from an expired gas analyzer, and each of said first and second controllers control the amount of anesthetic agent delivered to a patient based on said signals.

12. The system or apparatus of claim 11 wherein the inspired gas analyzer and expired gas analyzer each comprise a sensor for analyzing the gas for concentration of at least one substance indicative of anesthetic agent concentration and a processor for calculating the effect of the agent based on the concentration and determining depth of anesthesia.

13. The system or apparatus of claim 12 wherein the sensor is selected from semiconductor gas sensor technology, surface acoustic wave gas sensor technology or conductive polymer gas sensor technology and further, optionally comprising:

respiratory phase sensor technology for determining a specific phase of the respiratory cycle from which the sample of breath is collected, and the sample of breath is collected from the initial phase or end-tidal phase.

14. The system or apparatus according to claim 1 for intravenously delivering a desired dose of anesthetic agent to a patient comprising:

an intravenous anesthetic supply having a controller for controlling the amount of anesthetic agent provided intravenously by the supply;

a breath analyzer for analyzing the patient'"'"'s breath for concentration of at least one substance indicative of the free anesthetic agent concentration in the patient'"'"'s bloodstream that provides a signal to indicate the free anesthetic agent concentration produced by the anesthetic agent intravenously delivered to the patient; and

a system controller connected to the anesthetic supply which receives the signal and controls the amount of anesthetic agent delivered intravenously based on the signal.

15. The system or apparatus of claim 14 wherein the breath analyzer comprises a collector for sampling the patient'"'"'s expired breath, a sensor for analyzing the breath for concentration of at least one substance indicative of the free anesthetic agent concentration in the patient'"'"'s blood, a processor for calculating the effect of the agent based on the concentration and determining depth of anesthesia.

16. The system or apparatus of claim 15 wherein the sensor is selected from semiconductor gas sensor technology, conductive polymer gas sensor technology, or surface acoustic wave gas sensor technology.

17. The system or apparatus according to claim 14 wherein said anesthetic agent is selected from the group comprising Remifentanil and Propofol.

18. The system or apparatus of claim 14 wherein the breath analyzer comprises a collector for sampling the patient'"'"'s expired breath, and a sensor for analyzing the breath for concentration of at least one substance indicative of the free anesthetic agent concentration in the patient'"'"'s blood.

19. The system or apparatus according to claim 1 for measuring the free concentration in blood of a patient of an intravenously administered anesthetic comprising:

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.

20. The system or apparatus according to claim 19 wherein said anesthetic is selected from the group comprising Remifentanil and Propofol.

21. The apparatus according to claim 19 further comprising a means for determining the fraction of the breath collected for analysis such that any particular breath fraction may be collected, including the only the end tidal breath fraction.

22. An anesthetic agent delivery system or apparatus for delivering a desired dose of anesthetic agent to a patient comprising:

(a) an anesthetic supply;

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

(c) a system controller connected to the anesthetic supply which receives the signal and controls the amount of anesthetic agent based on the signal;

wherein the breath analyzer comprises a collector for sampling the patient'"'"'s expired breath, a sensor for analyzing the breath for concentration of at least one substance indicative of the anesthetic agent concentration, a processor for calculating the effect of the agent based on the concentration and determining depth of anesthesia.

23. The system or apparatus of claim 22 wherein the sensor is selected from semiconductor gas sensor technology, surface acoustic wave gas sensor technology or conductive polymer gas sensor technology.

24. An anesthetic agent delivery system or apparatus for delivering a desired dose of anesthetic agent to a patient comprising:

(a) an anesthetic supply;

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

(c) a system controller connected to the anesthetic supply which receives the signal and controls the amount of anesthetic agent based on the signal;

wherein said anesthetic agent supply comprises an anesthetic gas supply, an intravenous agent supply;

further comprising an inspired gas analyzer for analyzing the concentration of anesthetic gas in the breathing circuit;

wherein said controller is connected to both an intravenous anesthetic supply and an anesthetic gas supply and which receives signals from both an inspired gas analyzer and an expired gas analyzer and controls the amount of anesthetic agents administered based on the signals or wherein a first controller receives a signal from an inspired gas analyzer and a second controller receives a signal from an expired gas analyzer, and each of said first and second controllers control the amount of anesthetic agent delivered to a patient based on said signals;

wherein the inspired gas analyzer and expired gas analyzer each comprise a sensor for analyzing the gas for concentration of at least one substance indicative of anesthetic agent concentration and a processor for calculating the effect of the agent based on the concentration and determining depth of anesthesia.

25. The system or apparatus of claim 24 wherein the sensor is selected from semiconductor gas sensor technology, surface acoustic wave gas sensor technology or conductive polymer gas sensor technology and further, optionally comprising:

respiratory phase sensor technology for determining a specific phase of the respiratory cycle from which the sample of breath is collected, and the sample of breath is collected from the initial phase or end-tidal phase.

27. The system or apparatus of claim 25 wherein the sensor is selected from semiconductor gas sensor technology, conductive polymer gas sensor technology, or surface acoustic wave gas sensor technology.

26. An anesthetic agent delivery system or apparatus for delivering a desired dose of anesthetic agent to a patient comprising:

(a) an anesthetic supply;

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

(c) a system controller connected to the anesthetic supply which receives the signal and controls the amount of anesthetic agent based on the signal;

said system for intravenously delivering a desired dose of anesthetic agent to a patient comprising;

an intravenous anesthetic supply having a controller for controlling the amount of anesthetic agent provided intravenously by the supply;

a breath analyzer for analyzing the patient'"'"'s breath for concentration of at least one substance indicative of the free anesthetic agent concentration in the patient'"'"'s bloodstream that provides a signal to indicate the free anesthetic agent concentration produced by the anesthetic agent intravenously delivered to the patient; and

a system controller connected to the anesthetic supply which receives the signal and controls the amount of anesthetic agent delivered intravenously based on the signal;

wherein the breath analyzer comprises a collector for sampling the patient'"'"'s expired breath, a sensor for analyzing the breath for concentration of at least one substance indicative of the free anesthetic agent concentration in the patient'"'"'s blood, a processor for calculating the effect of the agent based on the concentration and determining depth of anesthesia.