Systems and methods for activity level pacing

• US 10,617,874 B2
• Filed: 10/30/2017
• Issued: 04/14/2020
• Est. Priority Date: 10/31/2016
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kane, Michael J., Huelskamp, Paul
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US15/797,797
• Publication Number:
  US 20180117338A1
• Time in Patent Office: 897 Days
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7217 of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker
• CPC Class Codes: A61N 1/36535 controlled by body position or posture
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• 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

Abstract

Systems, devices, and methods for pacing a heart of a patient are disclosed. An illustrative method may include determining a motion level of the patient using a motion sensor of an implantable medical device secured relative to a patient'"'"'s heart, and setting a pacing rate based at least in part on the patient'"'"'s motion level. The patient'"'"'s motion level may be determined by, for example, comparing the motion level sensed by the motion sensor during a current heart beat to a motion level associated with one or more previous heart beats. Noise may occur in the motion level measurements during those heart beats that transition between an intrinsically initiated heart beat and pace initiated heart beat. Various techniques may be applied to the motion level measurements to help reduce the effect of such noise.

Claims

1. An implantable medical device (IMD) implantable within a patient'"'"'s heart, the IMD comprising:

two or more sensors including a motion sensor;

a controller operatively coupled to the two or more sensors, the controller configured to;

identify a plurality of heart beats using one or more of the sensors, each of the plurality of heart beats having a systole phase and diastole phase;

identify each of two or more of the plurality of heart beats as an intrinsically initiated heart beat or a pace initiated heart beat;

identify a calibration time window, and during the calibration time window;

identify a baseline intrinsic motion level by identifying a motion level of the IMD using the motion sensor during N intrinsically initiated heart beats, where N is greater than two;

identify a baseline pace motion level by identifying a motion level of the IMD using the motion sensor during N pace initiated heart beats, where N is greater than two;

determine an offset based at least in part on the baseline intrinsic motion level and the baseline pace motion level;

after the calibration time window;

for an intrinsically initiated heart beat that immediately follows a pace initiated heart beat, identify a motion level of the IMD using the motion sensor and apply the offset, and compare the identified motion level of the IMD with the applied offset to a motion level of the IMD identified for the immediately preceding pace initiated heart beat, and identify a motion level of the patient based at least in part on the comparison; and

set a pacing rate parameter based at least in part on the identified motion level of the patient.

2. The IMD of claim 1, wherein, after the calibration time window, the controller is further configured to:

for a pace initiated heart beat that immediately follows an intrinsic initiated heart beat, identify a motion level of the IMD using the motion sensor and apply the offset, and compare the identified motion level of the IMD with the applied offset to a motion level of the IMD identified for the immediately preceding intrinsically initiated heart beat, and identify a motion level of the patient based at least in part on the comparison.

3. The IMD of claim 2, wherein, after the calibration time window, the controller is further configured to:

for an intrinsically initiated heart beat that immediately follows an intrinsically initiated heart beat, identify a motion level of the IMD using the motion sensor during the systole phase of the intrinsically initiated heart beat, and compare the identified motion level of the IMD to a motion level of the IMD identified for one or more previous intrinsically initiated heart beats, and identify a motion level of the patient based at least in part on the comparison.

4. The IMD of claim 3, wherein, after the calibration time window, the controller is further configured to:

for a pace initiated heart beat that immediately follows a pace initiated heart beat, identify a motion level of the IMD using the motion sensor during the systole phase of the pace initiated heart beat, and compare the identified motion level of the IMD to a motion level of the IMD identified for one or more previous pace initiated heart beats, and identify the motion level of the patient based at least in part on the comparison.

5. The IMD of claim 1, wherein the N intrinsically initiated heart beats are N consecutive intrinsically initiated heart beats.

6. The IMD of claim 1, wherein the N pace initiated heart beats are N consecutive pace initiated heart beats.

7. The IMD of claim 1, wherein the calibration time window is a time window where patient activity is expected to be low.

8. The IMD of claim 1, wherein the calibration time window is initiated after a particular posture of the patient is detected by the IMD.

9. The IMD of claim 8, wherein the IMD is configured to detect each of N different postures, wherein N is greater than two, and wherein the controller is configured to:

identify a calibration time window for each N different postures, and during each calibration time window;

identify a baseline intrinsic motion level for the corresponding posture by identifying a motion level of the IMD using the motion sensor during the systole phase of N intrinsically initiated heart beats, where N is greater than two;

identify a baseline pace motion level for the corresponding posture by identifying a motion level of the IMD using the motion sensor during the systole phase of N pace initiated heart beats, where N is greater than two;

determine an offset for each of the N different postures based at least in part on the baseline intrinsic motion level that corresponds to the corresponding posture and the baseline pace motion level that corresponds to the corresponding posture;

after the calibration time window for each of the N different postures;

identify a current posture of the patient as one of the N different postures;

for an intrinsically initiated heart beat that immediately follows a pace initiated heart beat, identify a motion level of the IMD using the motion sensor during the systole phase of the intrinsically initiated heart beat and apply the offset that corresponds to the current posture, and compare the identified motion level of the IMD with the applied offset that corresponds to the current posture to a motion level of the IMD identified for the immediately preceding pace initiated heart beat, and identify a motion level of the patient based at least in part on the comparison.

10. The IMD of claim 1, wherein the calibration time window is initiated at a particular time of day.

11. The IMD of claim 1, wherein the calibration time window is initiated after the motion level of the patient falls below a threshold for at least a predetermined length of time.

12. The IMD of claim 1, wherein the controller is further configured to:

during the calibration time window;

pace the patient'"'"'s heart at a pacing rate that is above a current intrinsic heart rate of the patient; and

while pacing the patient'"'"'s heart at the pacing rate that is above the current intrinsic heart rate of the patient, identify the baseline pace motion level by identifying the motion level of the IMD using the motion sensor during the systole phase of N pace initiated heart beats, where N is greater than two.

13. A method for identifying an activity level of a patient using a motion sensor implanted within the patient'"'"'s heart, the method comprising:

identifying a plurality of heart beats using the motion sensor, each of the plurality of heart beats having a systole phase and diastole phase;

identifying each of two or more of the plurality of heart beats as an intrinsically initiated heart beat or a pace initiated heart beat;

identifying a calibration time window, and during the calibration time window;

identifying a baseline intrinsic motion level by identifying a motion level of the IMD using the motion sensor during N intrinsically initiated heart beats, where N is greater than two;

identifying a baseline pace motion level by identifying a motion level of the IMD using the motion sensor during N pace initiated heart beats, where N is greater than two;

determining an offset based at least in part on the baseline intrinsic motion level and the baseline pace motion level; and

after the calibration time window;

for an intrinsically initiated heart beat that immediately follows a pace initiated heart beat, identifying a motion level of the IMD using the motion sensor and apply the offset, and comparing the identified motion level of the IMD with the applied offset to a motion level of the IMD identified for the immediately preceding pace initiated heart beat, and identifying a motion level of the patient based at least in part on the comparison.

14. The method of claim 13 further comprising setting a pacing rate parameter based at least in part on the identified motion level of the patient.

15. The method of claim 13, wherein, after the calibration time window, the method further comprises:

for a pace initiated heart beat that immediately follows an intrinsic initiated heart beat, identifying a motion level of the IMD using the motion sensor and apply the offset, and comparing the identified motion level of the IMD with the applied offset to a motion level of the IMD identified for the immediately preceding intrinsically initiated heart beat, and identifying a motion level of the patient based at least in part on the comparison.

16. The method of claim 13, wherein, after the calibration time window, the method further comprises:

for an intrinsically initiated heart beat that immediately follows an intrinsically initiated heart beat, identifying a motion level of the IMD using the motion sensor during the systole phase of the intrinsically initiated heart beat, and comparing the identified motion level of the IMD to a motion level of the IMD identified for one or more previous intrinsically initiated heart beats, and identifying a motion level of the patient based at least in part on the comparison; and

for a pace initiated heart beat that immediately follows a pace initiated heart beat, identifying a motion level of the IMD using the motion sensor during the systole phase of the pace initiated heart beat, and comparing the identified motion level of the IMD to a motion level of the IMD identified for one or more previous pace initiated heart beats, and identifying the motion level of the patient based at least in part on the comparison.

17. The method of claim 13, wherein the N intrinsically initiated heart beats are N consecutive intrinsically initiated heart beats, and wherein the N pace initiated heart beats are N consecutive pace initiated heart beats.

18. A leadless cardiac pacemaker (LCP) implantable within a patient'"'"'s heart, the LCP comprising:

a housing;

two or more electrodes secured relative to the housing, the two or more electrodes are configured to sense electrical signals of the patient'"'"'s heart;

an accelerometer situated inside of the housing;

circuitry situated inside of the housing and operatively coupled to the two or more electrodes and the accelerometer, the circuitry is configured to;

identify a plurality of heart beats using two or more of the electrodes, each of the plurality of heart beats having a systole phase and diastole phase;

identify each of two or more of the plurality of heart beats as an intrinsically initiated heart beat or a pace initiated heart beat;

identify a calibration time window, and during the calibration time window;

identify a baseline intrinsic motion level by identifying a motion level of the LCP using the accelerometer during the systole phase of N intrinsically initiated heart beats, where N is greater than two;

identify a baseline pace motion level by identifying a motion level of the LCP using the accelerometer during the systole phase of N pace initiated heart beats, where N is greater than two;

identify an offset based at least in part on the baseline intrinsic motion level and the baseline pace motion level;

after the calibration time window;

for an intrinsically initiated heart beat that immediately follows a pace initiated heart beat, identify a motion level of the LCP using the accelerometer during the systole phase of the intrinsically initiated heart beat and apply the offset, and compare the identified motion level of the LCP with the applied offset to a motion level of the LCP identified for the immediately preceding pace initiated heart beat, and identify a motion level of the patient based at least in part on the comparison;

for a pace initiated heart beat that immediately follows an intrinsic initiated heart beat, identify a motion level of the LCP using the accelerometer during the systole phase of the pace initiated heart beat and apply the offset, and compare the identified motion level of the LCP with the applied offset to a motion level of the LCP identified for the immediately preceding intrinsically initiated heart beat, and identify a motion level of the patient based at least in part on the comparison;

for an intrinsically initiated heart beat that immediately follows an intrinsically initiated heart beat, identify a motion level of the LCP using the accelerometer during the systole phase of the intrinsically initiated heart beat, and compare the identified motion level of the LCP to a motion level of the LCP identified for one or more previous intrinsically initiated heart beats, and identify a motion level of the patient based at least in part on the comparison;

for a pace initiated heart beat that immediately follows a pace initiated heart beat, identify a motion level of the LCP using the accelerometer during the systole phase of the pace initiated heart beat, and compare the identified motion level of the LCP to a motion level of the LCP identified for one or more previous pace initiated heart beats, and identify the motion level of the patient based at least in part on the comparison; and

set a pacing rate parameter based at least in part on the identified motion level of the patient.

19. The LCP of claim 18, wherein the N intrinsically initiated heart beats are N consecutive intrinsically initiated heart beats, and wherein the N pace initiated heart beats are N consecutive pace initiated heart beats.

20. The LCP of claim 18, wherein the calibration time window is a time window where patient activity is expected to be low.