System and method for detecting tamponade

• US 10,589,101 B2
• Filed: 11/15/2018
• Issued: 03/17/2020
• Est. Priority Date: 08/28/2015
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kane, Michael J., Shuros, Allan Charles, Schmidt, Brian L., Maile, Keith R., Haasl, Benjamin J.
• Primary Examiner(s): Lee, Erica S
• Application Number:
  US16/192,420
• Publication Number:
  US 20190083791A1
• Time in Patent Office: 488 Days
• Field of Search: None
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• 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 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/3704 Circuits specially adapted therefor, e.g. for sensitivity control
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

Systems, methods, and devices for determining occurrences of a tamponade condition are disclosed. One exemplary method includes monitoring an accelerometer signal of a leadless cardiac pacemaker attached to a heart wall, determining if a tamponade condition of the patient'"'"'s heart is indicated based at least in part on the monitored accelerometer signal, and in response to determining that the tamponade condition is indicated, providing a notification of the tamponade condition for use by a physician to take corrective action.

Claims

1. A method for detecting a tamponade condition of a patient'"'"'s heart after attachment of a leadless cardiac pacemaker to the patient'"'"'s heart, the leadless cardiac pacemaker having a motion sensor that produces a motion signal, the method comprising:

monitoring two or more electrodes of the leadless cardiac pacemaker to detect a cardiac electrical signal of the patient'"'"'s heart;

monitoring the motion signal of the leadless cardiac pacemaker;

identifying a characteristic of the motion signal;

determining when the tamponade condition is indicated based at least in part on whether the identified characteristic of the motion signal changes over time in a predetermined way during a sensing window that is defined at least in part by one or more characteristics of the cardiac electrical signal; and

in response to determining that the tamponade condition is indicated, providing a notification of the tamponade condition for use by a physician to take corrective action.

2. The method of claim 1, wherein the motion sensor comprises an accelerometer, and the motion signal comprises an accelerometer signal.

3. The method of claim 2, wherein the accelerometer comprises a multi-axis accelerometer, and the accelerometer signal is a multi-axis accelerometer signal.

4. The method of claim 2, wherein the identified characteristic of the motion signal is indicative of a displacement of a wall of the patient'"'"'s heart.

5. The method of claim 2, wherein the identified characteristic of the motion signal is indicative of a filling volume of the patient'"'"'s heart.

6. The method of claim 2, wherein the identified characteristic of the motion signal is indicative of a heart sound of the patient'"'"'s heart.

7. The method of claim 2, wherein the leadless cardiac pacemaker further comprises a pressure sensor that produces a pressure signal, the method further comprising:

determining when the tamponade condition is indicated based at least in part on whether the identified characteristic of the motion signal changes over time in a predetermined way and based on the pressure signal.

8. The method of claim 1, wherein the motion sensor comprises a gyroscope and the motion signal comprises a gyroscope signal.

9. The method of claim 8, wherein the gyroscope comprises a multi-axis gyroscope, and the gyroscope signal is a multi-axis gyroscope signal.

10. The method of claim 8, further comprising:

monitoring two or more electrodes of the leadless cardiac pacemaker to detect a cardiac electrical signal of the patient'"'"'s heart; and

determining when the tamponade condition is indicated based at least in part on whether a synchrony between the identified characteristic of the gyroscope signal changes over time relative to the cardiac electrical signal.

11. The method of claim 1, wherein the leadless cardiac pacemaker performs the monitoring, determining and providing steps.

12. The method of claim 1, wherein the leadless cardiac pacemaker performs the monitoring step.

13. The method of claim 1, wherein an external device programmer performs one or more of the monitoring, determining and providing steps.

14. The method of claim 1, wherein providing the notification comprises communicating a message from the leadless cardiac pacemaker for reception by an external device programmer.

16. The leadless cardiac pacemaker of claim 11, wherein the motion sensor comprises an accelerometer and/or a gyroscope.

15. A leadless cardiac pacemaker for use in pacing a patient'"'"'s heart, comprising:

a plurality of electrodes;

a motion sensor for providing an motion signal;

a controller operatively coupled to the plurality of electrodes and the motion sensor, the controller configured to;

monitor two or more of the plurality of electrodes to detect a cardiac electrical signal of the patient'"'"'s heart;

monitor the motion signal of the motion sensor over time;

identifying a characteristic of the motion signal;

determining when a tamponade condition is indicated based at least in part on whether the identified characteristic of the motion signal changes over time in a predetermined way during a sensing window that is defined at least in part by one or more characteristics of the cardiac electrical signal; and

in response to determining that the tamponade condition is indicated, communicate a notification of the tamponade condition for use by a physician to take corrective action.

17. A leadless cardiac pacemaker, comprising:

a plurality of electrodes;

a motion sensor for providing a motion signal;

a controller operatively coupled to the plurality of electrodes and the motion sensor, the controller configured to;

monitor two or more of the plurality of electrodes to detect a cardiac electrical signal of the patient'"'"'s heart;

monitor an indication of physical motion of a patient'"'"'s heart over time using the motion sensor;

determine when the indication of the physical motion of the patient'"'"'s heart changes over time in a predetermined way during a sensing window that is defined at least in part by one or more characteristics of the cardiac electrical signal; and

when it is determined that the indication of the physical motion of the patient'"'"'s heart has changed over time in the predetermined way, communicate a notification of a possible tamponade condition for reception by a remote device that is remote from the leadless cardiac pacemaker.

18. The leadless cardiac pacemaker of claim 17, wherein the controller is further configured to monitor a heart rate of the patient'"'"'s heart over time and to determine if the heart rate increases over time by at least a predetermined heart rate amount.

19. The leadless cardiac pacemaker of claim 18, wherein the controller communicates a notification of the possible tamponade condition when it is determined that the indication of the physical motion of the patient'"'"'s heart has changed over time in the predetermined way and the heart rate of the patient'"'"'s heart has increased over time by at least the predetermined heart rate amount.