Method and apparatus for diagnosing respiratory disorders and determining the degree of exacerbations

• US 8,801,620 B2
• Filed: 04/25/2006
• Issued: 08/12/2014
• Est. Priority Date: 04/25/2005
• Status: Active Grant

• 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., Euliano, Neil R.
• Primary Examiner(s): D'Angelo, Michael
• Assistant Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US11/909,004
• Publication Number:
  US 20080190430A1
• Time in Patent Office: 3,031 Days
• Field of Search: 600529-543, 600/484, 600/481, 600/483, 600/500
• US Class Current: 600/484
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/085 Measuring impedance of respiratory organs or lung elasticity
• CPC Class Codes: A61B 5/1073 Measuring volume, e.g. of limbs
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/4884 inducing physiological or psychological stress, e.g. applications for stress testing
• CPC Class Codes: A61M 16/0069 the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• CPC Class Codes: A61M 16/1005 with O2 features or with parameter measurement
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)

Abstract

Disclosed herein are apparatuses and methods to monitor respiration and abnormal respiration events utilizing plethysmography. The apparatuses and methods provide an alternative to conventional respiration monitoring methods while enabling accurate yet minimally interruptive and invasive monitoring of respiration. The methods and apparatuses may be employed in the context of sleep studies to determine respiratory related sleep disorders.

Claims

1. A method of monitoring respiration in a patient, said method comprising:

securing a pulse oximeter probe to a central source site of said patient, wherein said probe is configured to generate a photoplethysmography waveform;

processing said plethysmography waveform from said probe to obtain a separate pulsatile arterial component waveform and a separate venous impedance component waveform; and

quantifying in real time with a computer said pulsatile arterial component waveform, said venous impedance component waveform, or both, to determine respiratory rate, occurrence of an inspiratory event, occurrence of an expiratory event, occurrence of an air restriction event, occurrence of an air obstruction event, or a combination thereof,

wherein quantifying in real time comprises evaluating changes in an amplitude of a waveform, peak or trough counting, peak-peak timing, peak-trough height, area under a curve, shape of curves, or evaluating changes in positions of peaks, troughs or midpoints from heartbeat to heartbeat or breath to breath.

2. The method of claim 1, wherein processing said signal stream comprises

identifying peaks and troughs of a raw plethysmography waveform;

identifying minimum values or midpoints between said peaks and troughs that exist at the expected heart rate, wherein the interpolated line connecting said midpoints or minimum values represents said venous impedance component waveform; and

extracting said venous impedance component waveform from said raw plethysmography waveform thereby obtaining said separate pulsatile arterial component waveform and said separate venous impedance component waveform.

3. The method of claim 1, wherein said central source site is a nasal septum or a nasal alar.

4. The method of claim 1, wherein quantifying comprises analyzing two or more datasets of signal information obtained at separate time periods.

5. The method of claim 1, wherein processing said plethysmography waveform comprises processing plethysmography signal information generated while said patient is asleep.

6. The method of claim 1, wherein said pulsatile arterial component waveform, said venous impedance component waveform, or both, are quantified to determine the respiratory rate of said patient.

7. The method of claim 1, wherein said pulsatile arterial component waveform, said venous impedance component waveform or both, are quantified to determine the occurrence of air restriction and/or the occurrence of air obstruction in said patient.

8. The method of claim 1, wherein said central source site is the nasal alar.

9. The method of claim 1, wherein quantifying in real time comprises evaluating changes in amplitude of waveform.

10. The method of claim 1, wherein quantifying in real time comprises peak or trough counting.

11. The method of claim 1, wherein quantifying in real time comprises evaluating peak-peak timing.

12. The method of claim 1, wherein quantifying in real time comprises evaluating peak-trough height.

13. The method of claim 1, wherein quantifying in real time comprises evaluating the area under the curve.

14. The method of claim 1, wherein quantifying in real time comprises evaluating the shape of the curves.

15. The method of claim 1, wherein quantifying in real time comprises evaluating changes in the positions of peaks, troughs or midpoints from heartbeat to heartbeat or breath to breath.

16. A method of monitoring respiration in a patient, said method comprising:

securing a pulse oximeter probe to a central source site of said patient wherein said probe is configured to generate a plethysmography waveform;

processing said plethysmography waveform from said probe to obtain a venous impedance component waveform; and

quantifying in real time with a computer changes in said venous impedance component waveform to determine respiratory rate, occurrence of an inspiratory event, occurrence of an expiratory event, occurrence of air restriction, occurrence of air obstruction, or a combination thereof, of said patient,

wherein quantifying in real time comprises evaluating changes in an amplitude of a waveform, peak or trough counting, peak-peak timing, peak-trough height, area under a curve, shape of curves, or evaluating changes in positions of peaks, troughs or midpoints from heartbeat to heartbeat or breath to breath.

17. The method of claim 16, wherein said changes in venous impedance component waveform are quantified to determine the respiratory rate of said patient.

18. The method of claim 16, wherein said changes in the venous impedance component waveform are quantified to determine the occurrence of air obstruction and/or the occurrence of air restriction in said patient.

19. A system for monitoring respiration of a patient comprising

at least one pulse oximeter probe configured for securing to a central source site of said patient and effective to generate a plethysmography waveform;

and

a computer communicatingly connected to said at least one pulse oximeter probe, said computer comprising

at least one processing module,

a first computer-readable program code module configured to cause said computer to process said plethysmography waveform of said at least one pulse oximeter probe to obtain an arterial component waveform, a venous impedance component waveform, or both, and

a second computer-readable program code module configured to cause said computer to quantify in real time said pulsatile arterial component waveform, venous impedance component waveform, or both, to determine occurrence of an inspiratory event, occurrence of an expiratory event, occurrence of an air restriction event, occurrence of an air obstruction event, or a combination thereof, wherein quantifying in real time comprises evaluating changes in an amplitude of a waveform, peak or trough counting, peak-peak timing, peak-trough height, area under a curve, shape of curves, or evaluating changes in positions of peaks, troughs or midpoints from heartbeat to heartbeat or breath to breath.

20. The system of claim 19, wherein said computer further comprises a display screen.

21. A computer program product embodied on a non-transient computer-usable storage medium comprising

a computer-usable medium comprising computer readable program code modules embodied in said computer-usable medium, wherein said computer readable program code modules comprise:

a computer readable first program code module configured to cause said computer to process a plethysmography waveform obtained from a pulse oximeter probe by separating out a pulsatile arterial component waveform and a venous impedance component waveform; and

a computer-readable second program code module configured to cause said computer to quantify in real time said pulsatile arterial component waveform, said venous impedance waveform, or both, to determine an occurrence of an abnormal respiration event, wherein quantifying in real time comprises evaluating changes in an amplitude of a waveform, peak or trough counting, peak-peak timing, peak-trough height, area under a curve, shape of curves, or evaluating changes in positions of peaks, troughs or midpoints from heartbeat to heartbeat or breath to breath.

22. A device useful for diagnosing a respiratory condition, said device comprising

a computer configured to communicate with at least one pulse oximeter probe, said computer comprising at least one processing module;

a first computer-readable program code module configured to cause said computer to process a plethysmography waveform from said at least one pulse oximeter probe to obtain a pulsatile arterial component waveform, a venous impedance component waveform, or both, and

a second computer-readable program code module configured to cause said computer to quantify in real time said pulsatile arterial component waveform, venous impedance component waveform, or both, to identify a respiratory condition, wherein quantifying in real time comprises evaluating changes in an amplitude of a waveform, peak or trough counting, peak-peak timing, peak-trough height, area under a curve, shape of curves, or evaluating changes in positions of peaks, troughs or midpoints from heartbeat to heartbeat or breath to breath.

23. The device of claim 22, further comprising a display screen effective to display information to a user of said device.

24. The device of claim 22, wherein said device is configured to operate in a calibrating mode and in an operational mode.

25. The device of claim 24, wherein in said calibrating mode, the device receives a first dataset of photoplethysmography signal information of a patient generated during respiration at a predetermined resistance, whereby said device is calibrated for said patient.

26. The device of claim 25, wherein in said operational mode, said device is configured to receive a second dataset of photoplethysmography signal information from said patient and said device compares said second dataset with said first dataset.

27. The device of claim 22, wherein said respiratory condition is

a restriction or obstruction of the nasopharynx caused by an allergy, bacterial infection or viral infection;

sleep apnea which results in a temporary partial or complete obstruction of the posterior pharynx during phases of the sleep cycle;

restriction or obstruction of the trachea or bronchi caused by tracheomalacia, tracheal polyps and warts, or bronchitis;

or

restriction or obstruction of the lower airways, caused by asthma, viral infection, bacterial infection, cystic fibrosis or chronic obstructive pulmonary disease.

28. The device of claim 22, wherein said device weighs less than 10 kilograms.

29. The device of claim 22, wherein said device is battery powered.

30. A method of diagnosing a respiration-related sleep disorder in a patient, said method comprising:

securing a pulse oximeter probe to a central source site of said patient wherein said probe is configured to generate a plethysmography waveform from said central source site;

processing said plethysmography waveform from said probe to obtain a separate pulsatile arterial component waveform and a separate venous impedance component waveform, wherein processing said plethysmography waveform comprises processing plethysmography signal information generated while said patient is asleep; and

quantifying in real time with a computer said arterial component waveform, said venous impedance component waveform, or both, to determine occurrence of an inspiratory event, occurrence of an expiratory event, occurrence of an air restriction event, occurrence of an air obstruction event, or a combination thereof, wherein quantifying in real time comprises evaluating changes in an amplitude of a waveform, peak or trough counting, peak-peak timing, peak-trough height, area under a curve, shape of curves, or evaluating changes in positions of peaks, troughs or midpoints from heartbeat to heartbeat or breath to breath.