System and method for outpatient management of chronic disease

• US 10,136,859 B2
• Filed: 12/21/2015
• Issued: 11/27/2018
• Est. Priority Date: 12/23/2014
• Status: Active Grant

• Current Assignee: Michael Cutaia
• Original Assignee: Michael Cutaia
• Inventors: Cutaia, Michael
• Primary Examiner(s): LUAN, SCOTT
• Application Number:
  US14/976,352
• Publication Number:
  US 20160174903A1
• Time in Patent Office: 1,072 Days
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/7271 Specific aspects of physiological measurement analysis A61B5/316, A61B5/349 and A61B5/374 take precedence
• CPC Class Codes: A61M 16/0051 with alarm devices
• 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 16/1005 with O2 features or with parameter measurement
• CPC Class Codes: A61M 16/101 using an oxygen concentrator
• CPC Class Codes: A61M 16/204 used for inhalation control
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/42 Rate
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

An outpatient ambulatory patient worn apparatus for managing chronic lung disease includes a plurality of sensors configured to be worn by a patient and to measure a plurality of physiological data. The plurality of sensors includes at least an oximeter, a respiratory rate sensor, and at least one activity or motion sensor. A central monitoring unit (CMU) is worn by the patient in an outpatient setting during activities of daily living. The CMU categorizes each recorded measurement of each of the plurality of sensors stored in a set of time stamped primary data by a predominate activity type to generate a set of activity type stamped data, the predominate activity types include rest, exertion, and sleep. A generate report process provides at least one or more reports. An outpatient ambulatory patient worn long-term oxygen therapy (LTOT) apparatus and a method for managing chronic lung disease are also described.

Claims

1. An outpatient ambulatory patient worn apparatus for managing chronic lung disease comprising:

a plurality of sensors configured to be worn by a patient and to measure a plurality of physiological data, said plurality of sensors including at least one oximeter, a respiratory rate sensor, and at least one activity or motion sensor, at least said oximeter, said at least one oximeter, said respiratory rate sensor, and said at least one activity or motion sensor continuously operative to measure said plurality of physiological data in an outpatient setting during activities of daily living comprising rest, exertion, and sleep;

a central monitoring unit (CMU) communicatively coupled to said plurality of sensors and to an interface device, said CMU comprising a computer, and said CMU to be worn by the patient in said outpatient setting during activities of daily living, said CMU programmed to record concurrently a set of time stamped primary data comprising measurement data from each of said plurality of sensors to a non-volatile memory at a predetermined interval for one or more epochs of time, and to categorize at an acquisition rate or some multiple of the acquisition rate each recorded measurement of each of said plurality of sensors stored in said set of time stamped primary data by a predominate activity type to generate a set of activity type stamped data, said predominate activity type selected from a plurality of activity types including rest, exertion, and sleep; and

a generate report process running on said CMU to provide at least one or more reports in real time including at least an indication or determination of whether a chronic lung disease treatment is needed by the patient based on said set of activity type stamped data.

2. The apparatus of claim 1, wherein said generate report process further generates a report or displays a temporal profile of physical activity during rest, exertion, and sleep.

3. The apparatus of claim 2, wherein said generate report process further generates a report or displays a determination of a temporal profile of a duration and magnitude of physical activity during rest, exertion, and sleep, correlated with a temporal profile of oxygenation.

4. The apparatus of claim 1, wherein said generate report process further generates a report or displays a determination of a frequency, a duration, and a magnitude of one or more hypoxemic events experienced by the patient.

5. The apparatus of claim 1, wherein said generate report process further generates a report or displays a summary of statistics for said plurality of sensors.

6. The apparatus of claim 1, wherein said generate report process further generates a report or displays a comparison of one or more variables between two or more segments of a recording made over two or more different epochs of time.

7. The apparatus of claim 1, wherein said generate report process further generates a report or displays a summary of statistics for a long term oxygen therapy (LTOT) comprising an adequacy of a LTOT prescription, or a degree of a patient compliance with an oxygen prescription of the patient during a selected epoch of time.

8. The apparatus of claim 1, wherein said generate report process further generates a report or displays a summary of statistics for an adequacy of a patient'"'"'s LTOT delivery system in the patient, or a report of a summary statistics of a comparison of one or more clinical parameters among different patients.

9. The apparatus of claim 1, wherein said CMU is communicatively coupled to an oxygen source or an oxygen delivery unit or to a separate flow meter or adapter flow valve to measure an oxygen flow to the patient.

10. The apparatus of claim 9, wherein said CMU regulates an oxygen flow to the patient based on an adequacy of oxygen delivery to the patient.

11. An outpatient ambulatory patient worn apparatus for regulation of long-term oxygen therapy (LTOT) delivery comprising:

a plurality of sensors configured to be worn by a patient and to measure a plurality of physiological data, said plurality of sensors including at least one oximeter, a respiratory rate sensor, and at least one activity or motion sensor, said at least one oximeter, said respiratory rate sensor, and said at least one activity or motion sensor continuously operative to measure said plurality of physiological data in an outpatient setting during activities of daily living comprising rest, exertion, and sleep;

a central monitoring unit (CMU) communicatively coupled to said plurality of sensors and to an interface device, said CMU comprising a computer, and said CMU to be worn by the patient in said outpatient setting during activities of daily living, said CMU programmed to record concurrently a set of time stamped primary data comprising measurement data from each of said plurality of sensors to a non-volatile memory at a predetermined interval for one or more epochs of time, and to categorize at an acquisition rate or some multiple of the acquisition rate each recorded measurement of each of said plurality of sensors stored in said set of time stamped primary data by a predominate activity type to generate a set of activity type stamped data; and

generate report process running on said CMU to provide at least one or more reports in real time at least a selected one of;

an indication or determination of whether a LTOT treatment is needed by the patient, and

an indication or determination of a LTOT adequacy of oxygen delivery to the patient, based on said set of activity type stamped data.

12. The LTOT apparatus of claim 11, wherein said predominate activity type comprises one of a plurality of activity types including rest, exertion, and sleep.

13. The LTOT apparatus of claim 11, wherein said CMU is communicatively coupled to an oxygen source or an oxygen delivery unit or to a separate flow meter or adapter flow valve to measure an oxygen flow to the patient.

14. The LTOT apparatus of claim 11, wherein said CMU regulates an oxygen flow to the patient based on said indication or determination of a LTOT adequacy of oxygen delivery to the patient.

15. The LTOT apparatus of claim 11, further comprising a flow valve or an adapter flow valve, and said CMU regulates an oxygen flow to the patient by control of said flow valve or said adapter flow valve in response to a physical activity of the patient as measured by at least one or more of said plurality of sensors or by a chest wall EMG measurement.

16. A method for managing chronic lung disease comprising the steps of:

providing a monitor system comprising;

a plurality of sensors configured to be worn by a patient and to measure a plurality of physiological data, said plurality of sensors including at least one oximeter, a respiratory rate sensor, and at least one activity or motion sensor, said at least one oximeter, said respiratory rate sensor, and said at least one activity or motion sensor continuously operative to measure said plurality of physiological data in an outpatient setting during activities of daily living comprising rest, exertion, and sleep;

a central monitoring unit (CMU) communicatively coupled to said plurality of sensors, said CMU comprising a computer, and said CMU worn by said patient in said outpatient setting during activities of daily living;

recording by said computer concurrently a set of time stamped primary data comprising measurement data from each of said plurality of sensors to a non-volatile memory at a predetermined interval for one or more epochs of time;

categorizing at an acquisition rate or some multiple of the acquisition rate each recorded measurement of each of said plurality of sensors stored in said set of time stamped primary data by a predominate activity type to generate a set of activity type stamped data;

generating and saving to a non-volatile computer memory one or more reports in one or more graphic or tabular clinical-user defined report formats based on said set of activity type stamped data; and

recording or displaying said one or more reports to manage a chronic lung disease.

17. The method of claim 16 where said step of providing comprises providing a physical activity sensor.

18. The method of claim 16 where said step of providing comprises providing a movement sensor.

19. The method of claim 16 where said step of providing comprises providing an energy expenditure sensor.

20. The method of claim 16 where said step of providing comprises providing a chest wall muscle EMG sensor.