Detection, diagnosis, and monitoring of a medical condition or disease with artificial olfactometry

• US 20040006257A1
• Filed: 03/04/2003
• Published: 01/08/2004
• Est. Priority Date: 03/04/2002
• Status: Active Grant

• Current Assignee: Smiths Detection (Smiths Group International Holdings Ltd.), Trustees Of The University Of Pennsylvania (University of Pennsylvania)
• Original Assignee: Cyrano Sciences, Inc. (Smiths Detection-Watford Ltd.)
• Inventors: Thaler, Erica R., Burch, Timothy E., Hanson, C. William III
• Granted Patent: US 7,255,677 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/4547 Evaluating teeth
• CPC Class Codes: G01N 33/0036 Specially adapted to detect a particular component all the other sub-groups of G01N33/0004 take precedence
• CPC Class Codes: G01N 33/497 of gaseous biological material, e.g. breath

Abstract

Methods and devices for rapid diagnosis and monitoring a patient for disease or effectiveness of treatment in real time. In preferred embodiments, the methods and devices comprise contacting an array of sensors with a sample from a mammal suspected of having a disease to generate a sensor array profile, measuring a clinical diagnostic marker for the suspected disease, and then developing a diagnosis using the sensor array profile in combination with the clinical diagnostic marker.

Claims

1. A method for detecting a physiological condition in a mammal, said method comprising:

(a) contacting an array of sensors with a sample from a mammal suspected of having a physiological condition to generate a sensor array response profile;

(b) measuring a clinical diagnostic marker for said physiological condition; and

(c) developing a diagnosis using said sensor array response profile in combination with a clinical diagnostic marker, thereby detecting said physiological condition in a mammal.

2. The method of claim 1, wherein said sensor array response profile is generated prior to measuring said clinical diagnostic marker.

3. The method of claim 1, wherein said sensor array response profile is generated concurrently with measuring said clinical diagnostic marker.

4. The method of claim 1, wherein said sensor array response profile is generated subsequently to measuring said clinical diagnostic marker.

5. The method of claim 1, further comprising analyzing said sensor array response profile to identify a marker gas in said sample.

6. The method of claim 5, wherein said marker gas is a member selected from the group consisting of alkanes, alkenes, alkynes, dienes, cyclic hydrocarbons, aliphatic hydrocarbons, acyclic hydrocarbons, arenes, alcohols, amines, ethers, ketones, aldehydes, carbonyls, carbanions, polynuclear aromatics, biomolecules, sugars, isoprenes, isoprenoids, VOC, VOA, indoles, skatoles, diamines, pyridines, picolines, sulfur compounds, halogenated compounds, fatty acids, organic acids, organic bases, fixed gases, CO, CO₂, NO, NO₂, NH₃, H₂S, and COS.

7. The method of claim 6, wherein said marker gas is an off-gas of a microorganism selected from the group consisting of a virus, a fungus, and a bacterium.

8. The method of claim 6, wherein said marker gas is an off gas or a gas resulting from a chemical change produced by the physiological condition, the immune system response to the physiological condition, or the response to therapeutic treatment.

9. The method of claim 7, wherein said marker gas is an off gas of a member selected from the group consisting of Streptococcus pneumoniae, Streptococcus pyogenes, Staphylococcus aureus, Moraxella catarrhalis, and Haemophilus influenzae.

10. The method of claim 7, wherein said marker gas is an off gas of a member selected from the group consisting of Prevotella intermedia, Fusobacterium nucleatum, Porphyromonas gingivalis, Porphyromonas endodontalis, Prevotella loescheii, Hemophilus parainfluenzae, Stomatococcus muci, Treponema denticola, Veillonella species, Peptostreptococcus anaerobius, Micros prevotii, Eubacterium limosum, Centipeda periodontii, Selemonad aremidis, Eubacterium species, Bacteriodes species, Fusobacterium periodonticum, Prevotella melaninogenica, Klebsiella pneumoniae, Enterobacter cloacae, Citrobacter species, Stomatococcus mucilaginus, and Pseudomonas aeruginosa.

11. The method of claim 1, wherein said clinical diagnostic marker is a member selected from the group consisting of Clinical Pulmonary Infection Score (CPIS), temperature, serology, erthyrocyte count, leukocyte count, secretion amount and character, radiography, respiratory function, and microbiological culture.

12. The method of claim 1, wherein said sample is selected from the group consisting of the breath of a mammal, the breath condensate of a mammal, the saliva of a mammal, the blood of a mammal, the mucous of a mammal, the swabbings obtained from a mammal, an off gas of a secretion, and the urine of a mammal.

13. The method of claim 12, wherein said sample is the breath of a mammal.

14. The method of claim 13, wherein said breath of a mammal is taken directly from a ventilator.

15. The method of claim 1, wherein said physiological condition is a disease, wherein said disease is a viral infection, a bacterial infection, or a fungal infection.

16. The method of claim 15, wherein said disease is a bacterial infection.

17. The method of claim 16, wherein said disease is a lower respiratory tract infection.

18. The method of claim 17, wherein said lower respiratory tract infection is pneumonia or bronchitis.

19. The method of claim 18, wherein said pneumonia is ventilator-associated pneumonia (VAP).

20. The method of claim 16, wherein said disease is an upper respiratory tract infection.

21. The method of claim 20, wherein said disease is sinusitis, pharyngitis, or otitis media.

22. The method of claim 1, wherein said array of sensors is in a separate unit, embedded in ventilator tubing, embedded in the ventilator filter, or located in the fluid stream between the patient lungs and the pump.

23. The method of claim 1, wherein said array of sensors is contained in a handheld device.

24. A method for determining whether a mammal has a disease, said method comprising:

(a) contacting an array of sensors with a sample from a mammal suspected of having a disease to generate a first sensor array response profile; and

(b) comparing said first sensor array response profile with a sensor array profile from a healthy mammal, thereby detennining whether a mammal has said disease.

25. A method for determining the severity of a disease in a mammal, said method comprising:

(a) contacting an array of sensors with a sample from a mammal suspected of having a disease to generate a first sensor array response profile;

(b) contacting an array of sensors with a sample from a mammal suspected of having a disease to generate a second sensor array response profile; and

(c) evaluating the difference between the first and second sensor array profiles, thereby determining the severity of said disease.

26. A method for monitoring physiological condition in a mammal, said method comprising:

(a) contacting an array of sensors with a sample from a mammal having a physiological condition to generate a baseline sensor array response profile;

(b) measuring a clinical diagnostic marker for said physiological condition;

(c) determining the severity of the physiological condition using said sensor array response profile in combination with said clinical diagnostic marker;

(d) contacting an array of sensors with a sample from a mammal having a disease for a second time to generate a second sensor array response profile;

(e) measuring said clinical diagnostic marker for said disease for a second time;

(f) determining the severity of the disease using said first and second sensor array response profiles in combination with the first and second measurement of said clinical diagnostic marker, thereby monitoring said disease in a mammal.