Method and Apparatus for Remote Detection and Monitoring of Functional Chronotropic Incompetence

• US 20110270049A1
• Filed: 10/22/2010
• Published: 11/03/2011
• Est. Priority Date: 10/22/2009
• Status: Active Grant

• Current Assignee: Medtronic Monitoring, Inc. (Medtronic Plc)
• Original Assignee: Corventis
• Inventors: Libbus, Imad, Katra, Rodolphe, Chakravarthy, Niranjan
• Granted Patent: US 8,790,259 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• 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 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

Abstract

Methods and apparatus to determine the presence of and track functional chronotropic incompetence (hereinafter “CI”) in an in-home setting under conditions of daily living. The functional CI of the patient may be determined with one or more of a profile of measured patient heart rates, a measured maximum patient heart rate, or a peak of the heart rate profile, such as the peak of a heart rate distribution profile. The functional CI of the patient may be determined with the measured heart rate profile, in which the measured heart rate profile may correspond to heart rates substantially less than the maximum heart rate of the patient, such that the heart rate can be safely measured when the patient is remote from a health care provider. The functional CI of the patient may be determined based a peak of the remotely measured heart rate profile, for example a peak corresponding to the mode of the heart rate distribution profile. For example, the relative amounts of the profile of heart rates above the peak and heart rates below the peak can be compared to determine the CI. The peak of the heart rate profile of the remote heart rate data may be used to determine the heart rate reserve and functional CI of the patient. The changes in HR can be measured and correlated to one or more sensor parameters such as activity to determine CI of the patient.

Claims

1. An apparatus to monitor a patient, the apparatus comprising,

a processor system comprising at least one processor having a tangible medium with instructions of a computer program embodied thereon, the processor system configured to receive heart rate data of the patient and determine a profile of the heart rates and wherein the processor is configured to identify chronotropic incompetence of the patient based on the profile of the heart rates.

2. The apparatus of claim 1 wherein the computer program comprises instructions to identify the functional CI with one or more measurement of location of the heart rate data, measures of dispersion and variability of the heart rate data, skewness and kurtosis of the heart rate data, or comparison of portions around a mode of a single modal mounded distribution.

3. The apparatus of claim 1 wherein the computer program comprises instructions to determine a peak of the profile and a first portion of the profile and a second portion of the profile, the first portion corresponding to a first amount of occurrences of first heart rates less than the peak and the second portion corresponding to a second amount of occurrences of second heart rates greater than the peak and wherein the chronotropic incompetence is identified based on the second amount smaller than the first amount.

4. An apparatus to monitor a remote patient, the apparatus comprising:

a processor system comprising at least one processor having a tangible medium with instructions of a computer program embodied thereon, the processor system configured to receive heart rate data of the remote patient and determine a distribution of the heart rates and wherein the processor is configured to identify a chronotropic incompetence of the patient based on the distribution of heart rates.

5. The apparatus of claim 4 wherein the computer program comprises instructions to receive respiration data of the patient and activity data of the patient and instructions to combine the heart rate data with the respiration data and activity data to identify the chronotropic incompetence.

6. The apparatus of claim 4 wherein the computer program comprises instructions to determine a peak of the distribution and a first portion of the distribution and a second portion of the distribution, the first portion corresponding to a first amount of occurrences of first heart rates less than the peak and the second portion of the distribution corresponding to a second amount of occurrences of second heart rates greater than the peak and wherein the chronotropic incompetence is identified based on the second amount smaller than the first amount.

7. A method of monitoring a patient, the method comprising,

providing a processor system comprising at least one processor having a tangible medium with instructions of a computer program embodied thereon, the processor system configured to receive heart rate data of the patient and determine a profile of the heart rates;

wherein the chronotropic incompetence of the patient is identified based on the profile of the heart rates.

8. An apparatus to monitor a remote patient, the apparatus comprising,

a processor system comprising at least one processor having a tangible medium with instructions of a computer program embodied thereon, the processor system configured to receive data of the remote patient comprising heart rate data of the patient and activity data of the patient, wherein the processor system comprises instructions to determine activity of the patient to a threshold activity amount, and wherein the processor system comprises instructions to identify a chronotropic incompetence of the patient based on the heart rate data corresponding to activity of the patient above the threshold.

9. The apparatus of claim 8 wherein the processor system comprises instructions to determine a maximum heart rate of the heart rate data corresponding to the activity of the patient above the threshold.

10. The apparatus of claim 9 wherein the processor system comprises instructions to determine a correlation of the maximum heart rate with one or more of the patient activity, patient body posture, patient breath rate or patient respiration rate and wherein the processor system is configured to identify CI based on the correlation.

11. The apparatus of claim 10 wherein the data of the patient comprises drug data of the patient and wherein the processor system comprises instructions to identify CI based on the drug data and the correlation.

12. The apparatus of claim 8 wherein patient data comprises data from an adherent device measured remotely and wherein the processor system comprises instructions to determine the threshold amount from a plurality of remote patients and corresponds to a percentile of patient activity of the plurality of remote patients.

13. A method of monitoring a remote patient, the method comprising,

providing a processor system comprising at least one processor having a tangible medium with instructions of a computer program embodied thereon, the processor system configured to receive data of the remote patient comprising heart rate data of the patient and activity data of the patient, wherein the processor system comprises instructions to determine activity of the patient to a threshold activity amount;

and

wherein a chronotropic incompetence of the patient is identified based on the heart rate data corresponding to activity of the patient above the threshold.

14. An apparatus to monitor a remote patient, the apparatus comprising,

a processor system comprising at least one processor having a tangible medium with instructions of a computer program embodied thereon, the processor system comprising instructions to receive heart rate data of the remote patient and to determine a peak of heart rates of the remote patient and wherein the processor system comprises instructions identify a chronotropic incompetence of the patient based on the peak.

15. The apparatus of claim 14 wherein the heart rates comprise a profile of heart rates and wherein the peak comprises a peak of the profile.

16. The apparatus of claim 14 wherein the heart rates comprise a distribution of heart rates and wherein the peak comprises a mode of the distribution.

17. The apparatus of claim 14 wherein the processor system comprises instructions to determine a heart rate reserve based on a difference of a maximum age predicted maximum heart rate and the peak and wherein the processor system is configured to determine the CI based on the heart rate reserve determined with the peak.

18. A method of monitoring a remote patient, the method comprising,

providing a processor system comprising at least one processor having a tangible medium with instructions of a computer program embodied thereon, the processor system comprising instructions to receive heart rate data of the remote patient and to determine a peak of heart rates of the remote patient;

wherein a chronotropic incompetence of the patient is identified based on the peak.

19. An apparatus to monitor a patient having a skin, the apparatus comprising,

an adherent device to measure patient data comprising wireless communication circuitry and measurement circuitry, the measurement circuitry coupled to at least two electrodes, a respiration sensor and an activity sensor, the adherent device comprising a support with an adhesive to adhere the at least two electrodes to the skin and support the wireless communication circuitry, the processor circuitry and the measurement circuitry with the skin;

a server located remote from the patient to receive the patient data; and

a gateway coupled to each of the adherent device and the server with wireless communication to transmit the patient data;

wherein one or more of the adherent device, the server or the gateway comprises at least one processor having a tangible memory medium with instructions of a computer program embodied thereon to determine a chronotropic incompetence of the patient based on the patient data measured with the at least two electrodes, the respiration sensor and the activity sensor.

20. The apparatus of claim 19 wherein the at least one processor comprises instructions to determine a distribution of heart rates of the patient and wherein the at least one processor is configured to determine the chronotropic incompetence based on the distribution heart rates.

21. The apparatus of claim 20 wherein the distribution of heart rates of the patient corresponds to a plurality of heart levels and an occurrence of each level.

22. The apparatus of claim 20 wherein the computer program comprises instructions to determine a peak of the distribution and a first portion of the distribution and a second portion of the distribution, the first portion corresponding to a first amount of occurrences of first heart rates less than the peak and the second portion of the distribution corresponding to a second amount of occurrences of second heart rates greater than the peak and wherein the chronotropic incompetence is determined based on the second amount smaller than the first amount.

23. The apparatus of claim 20 wherein the at least one processor comprises instructions to fit the distribution to a Gaussian distribution and determine a skew of the distribution and wherein the chronotropic incompetence is determined based on the skew.

24. The apparatus of claim 19 wherein the at least one processor comprises instructions to determine a distribution of heart rates of the patient, the distribution corresponding heart rates less than a maximum heart rate of the patient and wherein the at least one processor is configured to determine the chronotropic incompetence based on the distribution heart rate intervals corresponding to less than the maximum heart rate of the patient.

25. The apparatus of claim 19 wherein the at least one processor comprises instructions to determine a distribution of heart rates of the patient, the distribution corresponding to heart rates less than a maximum heart rate of the patient and wherein the at least one processor comprises instructions to determine the maximum heart rate of the patient based on the distribution heart rate intervals corresponding to less than the maximum heart rate of the patient.

26. The apparatus of claim 25 wherein the at least one processor comprises instructions to determine the chronotropic incompetence of the patient based on the maximum heart rate of the patient.

27. The apparatus of claim 19 wherein the at least one processor comprises instructions to determine the maximum heart rate of the patient based on the distribution of heart rates corresponding to less than the maximum heart rate of the patient.

28. A method of monitoring a patient, the method comprising:

measuring heart rate data of the patient;

providing a processor system comprising at least one processor having a tangible medium with instructions of a computer program embodied thereon, wherein the processor system receives heart rate data of the patient and determines a distribution of the heart rates and wherein the processor determines a chronotropic incompetence of the patient based on the distribution of heart rates.

29. The method of claim 28 the heart rate data comprise data measured from a patch adhered to the patient for at least about one week and wherein the heart rate data is transmitted with wireless communication.

30. An apparatus to monitor a patient, the apparatus comprising,

an adherent device means for measuring patient data;

and

processor means for determining a chronotropic incompetence of the patient.