Multi-parameter prediction of acute cardiac episodes and attacks

• US 10,463,295 B2
• Filed: 06/12/2017
• Issued: 11/05/2019
• Est. Priority Date: 06/13/2016
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Zhou, Xiaohong
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Lau, Michael J
• Application Number:
  US15/620,346
• Publication Number:
  US 20170354365A1
• Time in Patent Office: 876 Days
• Field of Search: 600301, 600509
• CPC Class Codes: A61B 2562/0204 Acoustic sensors
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/0261 Strain gauges
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7225 Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation A61B5/30, A61B5/316 take precedence; transformers for specific applications H01F38/00; amplifiers H03F
• 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 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/7435 Displaying user selection data, e.g. icons in a graphical user interface
• 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
• CPC Class Codes: A61N 1/0563 : specially adapted for defibrillation or cardioversion
• CPC Class Codes: A61N 1/37229 : Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37235 : Aspects of the external programmer
• CPC Class Codes: A61N 1/37288 : Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/37512 : Pacemakers
• CPC Class Codes: A61N 1/3756 : Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/395 : for treating atrial fibrillation
• CPC Class Codes: A61N 1/3962 : in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 : Pacing therapy
• CPC Class Codes: A61N 1/3987 : characterised by the timing or triggering of the shock
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment

Abstract

In some examples, processing circuitry of a medical device system determines, for each of a plurality of patient parameters, a difference metric for a current period based on a value of a patient parameter determined for the current period and a value of the patient parameter determined for an immediately preceding period, and determines a score for the current period based on a sum of the difference metrics for at least some of the plurality of patient parameters. The processing circuitry determines a threshold for the current period based on scores determined for N periods that precede the current period, compares the score for the current period to the threshold, and determines whether to generate an alert indicating that an acute cardiac event of the patient, e.g., ventricular tachyarrhythmia, is predicted, and/or deliver a therapy configured to prevent the acute cardiac event, based on the comparison.

Claims

1. A medical device system comprising:

sensing circuitry configured to generate one or more physiological signals of a patient; and

processing circuitry that, for each of a plurality of periods, is configured to;

determine a respective value for each of a plurality of patient parameters, wherein, for one or more of the plurality of patient parameters, the respective values are determined based on the one or more physiological signals generated during the period;

for each of the plurality of patient parameters, determine a difference metric for a current period for each of the plurality of periods based on a value of the patient parameter determined for the current period and a value of the patient parameter determined for an immediately preceding period of the plurality periods;

determine a score for the current period based on a sum of the difference metrics for the current period for the one or more of the plurality of patient parameters;

determine a threshold for the current period based on scores determined for N periods of the plurality of periods that precede the current period, wherein N is an integer constant;

compare the score for the current period to the threshold for the current period; and

determine whether to generate an alert indicating that an acute cardiac event of the patient is predicted based on the comparison.

2. The system of claim 1, wherein the processing circuitry is configured to determine a difference between the value of the patient parameter determined for the current period and the value of the patient parameter determined for the immediately preceding period as the difference metric for the current period.

3. The system of claim 1, wherein the processing circuitry is configured to determine the difference metric for the current period as a ratio between:

a difference between the value of the patient parameter determined for the current period and the value of the patient parameter determined for the immediately preceding period; and

a measure of variation of values of the patient parameter determined for the N periods of the plurality of periods that precede the current period.

4. The system of claim 3, wherein the measure of variation comprises a standard deviation of the values of the patient parameter determined for the N periods of the plurality of periods that precede the current period.

5. The system of claim 1, wherein the processing circuitry is configured to determine the score for the current period at least by determining a sum of squares of the difference metrics for the current period.

6. The system of claim 1, wherein the processing circuitry is configured to determine the threshold based on a median of the scores determined for the N periods preceding the current period.

7. The system of claim 1, wherein the processing circuitry is configured to:

compare one or more of the difference metrics for the current period to a patient parameter specific criterion; and

determine whether to include the one or more of the difference metrics in the sum based on the comparison.

8. The system of claim 1, wherein the alert indicates that a ventricular tachyarrhythmia is predicted.

9. The system of claim 1, wherein the processing circuitry is configured to:

detect the acute cardiac event during one of the plurality of periods; and

exclude the period during which the acute cardiac event was detected from N periods that precede the current period.

10. The system of claim 1, further comprising therapy delivery circuitry configured to deliver a therapy to the patient to prevent the predicted acute cardiac event, wherein the processing circuitry is configured to determine whether to control the therapy delivery circuitry to deliver the therapy based on the comparison of the score for the current period to the threshold for the current period.

11. The system of claim 10, wherein the therapy delivery circuitry is configured to deliver a plurality of therapies to the patient to prevent the predicted acute cardiac event, and wherein the processing circuitry is configured to:

for each of the plurality of patient parameters, compare the difference metric determined for the current period to difference metrics determined for the N periods preceding the current period;

identify one of the plurality of patient parameters having a most significant change in the difference metric from the N periods to the current period;

select one of the plurality of therapies associated with the identified one of the plurality of patient parameters; and

control the therapy delivery circuitry to deliver the selected one of the plurality of therapies.

12. The system of claim 1, further comprising an implantable medical device that comprises the sensing circuitry and the processing circuitry.

13. The system of claim 12, wherein the implantable medical device comprises an implantable cardioverter defibrillator further comprising therapy delivery circuitry configured to deliver anti-tachyarrhythmia shocks.

14. The system of claim 12, wherein the implantable medical device comprises a leadless monitor comprising a housing configured for subcutaneous implantation that houses the sensing circuitry and the processing circuitry, wherein the housing includes a plurality of electrodes coupled to the sensing circuitry, and wherein the sensing circuitry is configured to generate a subcutaneous cardiac electrogram based on cardiac signals sensed via the electrodes.

15. The system of claim 1, wherein the processing circuitry is further configured to:

identify one or more of the plurality of patient parameters that contributed to the score being greater than the threshold, wherein the processing circuitry identifies the one or more of the plurality of patient parameters having most significant changes in the difference metric from the N periods to the current period as the one or more of the plurality of patient parameters that contributed to the score being greater than the threshold; and

to at least one of;

exclude a patient parameter from the score for a subsequent period, include a patient parameter for a subsequent period, or modify one or more weights applied to one or more of the difference metrics when determining the score based on the identified one or more patient parameters.

16. The system of claim 15, wherein the processing circuitry is configured to select one or more preventative measures to deliver to the patient based on the one or more identified patient parameters that contributed to the score being greater than the threshold.

17. A method comprising:

generating, by sensing circuitry of a medical device system, one or more physiological signals of a patient; and

for each of a plurality of periods, by processing circuitry of the medical device system;

determining a respective value for each of a plurality of patient parameters, wherein, for one or more of the plurality of patient parameters, the respective values are determined based on the one or more physiological signals generated during the period;

for each of the plurality of patient parameters, determining a difference metric for a current period for each of the plurality of periods based on a value of the patient parameter determined for the current period and a value of the patient parameter determined for an immediately preceding period of the plurality periods;

determining a score for the current period based on a sum of the difference metrics for the current period for the one or more of the plurality of patient parameters;

determining a threshold for the current period based on scores determined for N periods of the plurality of periods that precede the current period, wherein N is an integer constant;

comparing the score for the current period to the threshold for the current period; and

determining whether to generate an alert indicating that an acute cardiac event of the patient is predicted based on the comparison.

18. The method of claim 17, wherein determining the difference metric for the current period comprises determining a difference between the value of the patient parameter determined for the current period and the value of the patient parameter determined for the immediately preceding period.

19. The method of claim 17, wherein determining the difference metric for the current period comprises determining a ratio between:

a difference between the value of the patient parameter determined for the current period and the value of the patient parameter determined for the immediately preceding period; and

a measure of variation of values of the patient parameter determined for the N periods of the plurality of periods that precede the current period.

20. The method of claim 19, wherein the measure of variation comprises a standard deviation of the values of the patient parameter determined for the N periods of the plurality of periods that precede the current period.

21. The method of claim 17, wherein determining the score for the current period comprises determining a sum of squares of the difference metrics for the current period.

22. The method of claim 17, wherein determining the threshold for the current period comprises determining a median of the scores determined for the N periods preceding the current period.

23. The method of claim 17, further comprising, by the processing circuitry:

comparing one or more of the difference metrics for the current period to a patient parameter specific criterion; and

determining whether to include the one or more of the difference metrics in the sum based on the comparison.

24. The method of claim 17, wherein the alert indicates that a ventricular tachyarrhythmia is predicted.

25. The method of claim 17, further comprising, by the processing circuitry:

detecting the acute cardiac event during one of the plurality of periods; and

excluding the period during which the acute cardiac event was detected from N periods that precede the current period.

26. The method of claim 17, further comprising, by the processing circuitry of the medical device system, determining whether to control therapy delivery circuitry of the medical device system to deliver a therapy to the patient to prevent the predicted acute cardiac event based on the comparison of the score for the current period to the threshold for the current period.

27. The method of claim 26, wherein the therapy delivery circuitry is configured to deliver a plurality of therapies to the patient to prevent the predicted acute cardiac event, the method further comprising, by the processing circuitry:

for each of the plurality of patient parameters, comparing the difference metric determined for the current period to difference metrics determined for the N periods preceding the current period;

identifying one of the plurality of patient parameters having a most significant change in the difference metric from the N periods to the current period;

selecting one of the plurality of therapies associated with the identified one of the plurality of patient parameters; and

controlling the therapy delivery circuitry to deliver the selected one of the plurality of therapies.

28. The method of claim 17, further comprising:

identifying one or more of the plurality of patient parameters that contributed to the score being greater than the threshold;

identifying the one or more of the plurality of patient parameters that contributed to the score being greater than the threshold comprises identifying one or more of the plurality of patient parameters having most significant changes in the difference metric from the N periods to the current period; and

at least one of;

excluding a patient parameter from the score for a subsequent period, including a patient parameter for a subsequent period, or modifying one or more weights applied to one or more of the difference metrics when determining the score based on the identified one or more patient parameters.

29. The method of claim 28, further comprising selecting one or more preventative measures to deliver to the patient based on the one or more identified patient parameters that contributed to the score being greater than the threshold.

30. A medical device system comprising:

means for generating one or more physiological signals of a patient; and

for each of a plurality of periods;

means for determining a respective value for each of a plurality of patient parameters, wherein, for one or more of the plurality of patient parameters, the respective values are determined based on the one or more physiological signals generated during the period;

for each of the plurality of patient parameters, means for determining a difference metric for a current period for each of the plurality of periods based on a value of the patient parameter determined for the current period and a value of the patient parameter determined for an immediately preceding period of the plurality periods;

means for determining a score for the current period based on a sum of the difference metrics for the current period for the one or more of the plurality of patient parameters;

means for determining a threshold for the current period based on scores determined for N periods of the plurality of periods that precede the current period, wherein N is an integer constant;

means for comparing the score for the current period to the threshold for the current period; and

means for determining whether to generate an alert indicating that an acute cardiac event of the patient is predicted based on the comparison.

31. A non-transitory computer-readable storage medium comprising instructions, that when executed by processing circuitry of a medical device system, cause the medical device system to:

receive one or more physiological signals of a patient; and

for each of a plurality of periods;

determine a respective value for each of a plurality of patient parameters, wherein, for one or more of the plurality of patient parameters, the respective values are determined based on the one or more physiological signals generated during the period;

for each of the plurality of patient parameters, determine a difference metric for a current period for each of the plurality of periods based on a value of the patient parameter determined for the current period and a value of the patient parameter determined for an immediately preceding period of the plurality periods;

determine a score for the current period based on a sum of the difference metrics for the current period for the one or more of the plurality of patient parameters;

determine a threshold for the current period based on scores determined for N periods of the plurality of periods that precede the current period, wherein N is an integer constant;

compare the score for the current period to the threshold for the current period; and

determine whether to generate an alert indicating that an acute cardiac event of the patient is predicted based on the comparison.