PATTERN RECOGNITION SYSTEM FOR QUANTIFYING THE LIKELIHOOD OF THE CONTRIBUTION OF MULTIPLE POSSIBLE FORMS OF CHRONIC DISEASE TO PATIENT REPORTED DYSPNEA

• US 20150032018A1
• Filed: 07/25/2014
• Published: 01/29/2015
• Est. Priority Date: 07/25/2013
• Status: Active Grant

• Current Assignee: Shape Medical Systems, Inc.
• Original Assignee: Shape Medical Systems, Inc.
• Inventors: Anderson, Stephen T., MacCarter, Dean J., Anderson, David M.
• Granted Patent: US 10,010,264 B2
• Time in Patent Office: Days
• US Class Current: 600/531
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/0826 Detecting or evaluating apnoea events A61B5/4818 takes precedence
• CPC Class Codes: A61B 5/0833 Measuring rate of oxygen consumption
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/091 Measuring volume of inspired or expired gases, e.g. to determine lung capacity
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick

Abstract

Systems and methods for quantifying the likelihood of the contribution of multiple possible forms of chronic disease to patient reported dyspnea can include the testing protocol having a flow/volume loop, performed at rest, flowed by the measurement of cardiopulmonary exercise gas exchange variables during rest, exercise and recovery as unique data sets. The data sets are analyzed using feature extraction steps to produce a pictorial image consisting of disease silos displaying the likelihood of the contribution of various chronic diseases to patient reported dyspnea. In some embodiments, the silos are split into subclass silos. In some embodiments, multiple chronic disease indexes are used to differentiate between sub-types of a particular chronic disease (e.g., differentiating WHO 1 PH from WHO 2 or WHO 3 PH). Test results are plotted serially to asses to provide feedback to the physician on the efficacy of therapy provided to the patient.

Claims

1. A system for characterizing contributions of physiological conditions to dyspnea in a patient, the system comprising:

a flow sensor configured to sense a respiratory flow of the patient;

an analyzer configured to determine a composition of at least a portion of the respiratory flow of the patient;

a computing device configured to;

receive gas exchange measurements based on breath-by-breath data captured by the flow sensor and the analyzer during a gas exchange test;

determine a first contribution value associated with a first physiological condition, wherein the first contribution value is based on the gas exchange measurements;

determine a second contribution value associated with a second physiological condition, wherein the second contribution value is based on the gas exchange measurements; and

output the first contribution value and the second contribution value.

2. The system of claim 1, wherein the computing device is further configured to receive spirometric measurements including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and inspiratory capacity (IC).

3. The system of claim 2, wherein the spirometric measurements are received from the flow sensor.

4. The system of claim 2, further comprising a user input device, wherein the spirometric measurements are entered using the user input device.

5. The system of claim 2, wherein the first contribution value is based on the spirometric measurements and the gas exchange measurements.

6. The system of claim 1, wherein the analyzer is configured to determine a concentration of one or more components of the respiratory flow, wherein the components are selected from a group of components comprising:

oxygen; and

carbon dioxide.

7. The system of claim 6, wherein the computing device is further configured to calculate at least one physiological parameter based on the gas exchange measurements, wherein the at least one physiological parameter is selected from a group of physiological parameters comprising:

respiratory rate (RR);

ventilation (VE);

rate of oxygen uptake or consumption (VO₂);

carbon dioxide production (VCO₂);

ventilatory efficiency (ratio, VE/VCO₂);

ventilatory efficiency (slope, VE/VCO₂);

end tidal CO₂;

end tidal CO2/respiratory rate (RR)

oxygen uptake efficiency slope (OUES);

V/Q ratio; and

pulmonary capacitance.

8. The system of claim 1, wherein the first physiological condition and the second physiological condition are selected from a group of physiological conditions consisting of heart failure, pulmonary arterial hypertension, pulmonary venous hypertension, obstructed lung, restricted lung, obesity, general deconditioning, and acute decompensated heart failure.

9. The system of claim 1, wherein the computing device is further configured to transmit data based on the gas exchange measurements to a server computing device over a network.

10. The system of claim 1, wherein the computing device is a mobile computing device.

11. The system of claim 1, wherein the computing device includes a display device and is further configured to generate a user interface that includes a visual indicator, wherein a property of the visual indicator is determined based on the first contribution value.

12. The system of claim 11, wherein the user interface includes a second visual indicator, wherein a property of the second visual indicator is based on the second contribution value.

13. The system of claim 12, wherein the properties of the first and second visual indicators are selected from a group of properties comprising:

size;

height;

and color.

14. The system of claim 1, further comprising a computer-readable data storage device and wherein the computing device is configured to display at least one historical visual indicator, wherein a property of the at least one historical visual indicator is determined based on a historical contribution value from a historical gas exchange test of the patient, data related to the historical gas exchange test being stored in the computer-readable data storage device.

15. The system of claim 1, wherein the gas exchange test includes a rest phase, an exercise phase, and a recovery period, wherein the patient performs exercise during the exercise phase.

16. A method for characterizing contributions of physiological conditions to dyspnea in a patient comprising:

receiving results of a spirometry test on the patient, wherein the spirometry test includes a flow-volume loop;

obtaining a plurality of spirometric measurements, including at least one of forced vital capacity (FVC), inspiratory capacity (IC), and forced expiratory volume in one second (FEV1);

performing, using a cardiopulmonary exercise gas exchange analyzer, a gas exchange test on the patient, wherein the gas exchange test includes a rest phase, an exercise phase, and a recovery period, wherein the patient performs exercise during the exercise phase;

obtaining a plurality of gas exchange measurements, including end tidal CO2, on a breath-by-breath basis during the gas exchange test;

determining a first contribution value associated with a first physiological condition, wherein the first contribution value is based on at least one of the plurality of spirometric measurements and at least one of the plurality of gas exchange measurements;

determining a second contribution value associated with a second physiological condition, wherein the second contribution value is based on at least one of the plurality of gas exchange measurements; and

displaying the first contribution value and the second contribution value.

17. The method of claim 16, wherein displaying the first contribution value and the second contribution value comprises generating a user interface that includes a first visual indicator and a second visual indicator, wherein a property of the first visual indicator is determined based on the first contribution value and a property of the second visual indicator is determined based on the second contribution value.

18. The method of claim 17, further comprising:

retrieving historical test data relating to a previous gas exchange test on the patient; and

wherein the user interface includes a first historical visual indicator and a second historical visual indicator, wherein a property of the first historical visual indicator is determined based on a first historical contribution value and a property of the second historical visual indicator is determined based on a second historical contribution value, the first historical contribution value being associated with the first physiological condition and being based on the historical test data, and the second historical contribution value being associated with the second physiological condition and being based on the historical test data.

19. The method of claim 16, wherein the first physiological condition and the second physiological condition are selected from a group of physiological conditions consisting of heart failure, pulmonary arterial hypertension, pulmonary venous hypertension, obstructed lung, restricted lung, obesity, general deconditioning, and acute decompensated heart failure.

20. A method for characterizing contributions of physiological conditions to dyspnea in a patient comprising:

performing a spirometry test on the patient using a flow sensor of a cardiopulmonary exercise gas exchange analyzer, wherein the spirometry test includes a flow-volume loop;

obtaining a plurality of spirometric measurements, including force vital capacity (FVC), inspiratory capacity (IC), and forced expiratory volume in one second (FEV1);

performing, using the cardiopulmonary exercise gas exchange analyzer, a gas exchange test on the patient, wherein the gas exchange test includes a rest phase, an exercise phase, and a recovery period, wherein the patient performs exercise during the exercise phase;

obtaining a plurality of gas exchange measurements, including end tidal CO2, on a breath-by-breath basis during the gas exchange test;

determining a first contribution value associated with a first physiological condition, wherein the first contribution value is based on at least one of the associated with a first weighted combination of at least one of the plurality of spirometric measurements and at least one of the plurality of gas exchange measurements;

determining a second contribution value associated with a second physiological condition, wherein the second contribution value is associated with a second weighted combination of one or more of the plurality of spirometric measurements and at least one or more of the plurality of gas exchange measurements;

retrieving historical test data relating to a previous gas exchange test on the patient;

generating a user interface that includes a first visual indicator, a second visual indicator, a third visual indicator, and a fourth visual indicator, wherein a property of the first visual indicator is determined based on the first contribution value, a property of the second visual indicator is determined based on the second contribution value, a property of the third visual indicator is determined based on a first historical contribution value associated with the first physiological condition and being based on the historical test data, and a property of the fourth visual indicator is determined based on a second historical contribution value associated with the second physiological condition and being based on the historical test data.