Ambulatory phrenic nerve stimulation detection

• US 9,421,383 B2
• Filed: 02/26/2014
• Issued: 08/23/2016
• Est. Priority Date: 03/13/2013
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Rockweiler, Holly, Saha, Sunipa, McCabe, Aaron R., Siejko, Krzysztof Z.
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US14/191,193
• Publication Number:
  US 20140277244A1
• Time in Patent Office: 909 Days
• Field of Search: 607/6, 607/9, 607/11, 607/17, 607/18
• US Class Current: 1/1
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

An example of a system includes an implantable medical device (IMD) for implantation in a patient, where the IMD includes a cardiac pace generator, phrenic nerve stimulation (PS) sensor, a memory, and a controller, and where the controller is operably connected to the cardiac pace generator to generate cardiac paces. The controller is configured to provide a trigger for conducting a PS detection procedure and perform the PS detection procedure in response to the trigger. In performing the PS detection procedure the controller is configured to receive a signal from the sensor, detect PS using the signal from the sensor, and record the PS detection in storage within the IMD.

Claims

1. A system, comprising:

an implantable medical device (IMD) for implantation in a patient, the IMD including a cardiac pace generator, a phrenic nerve stimulation (PS) sensor, a memory, and a controller, wherein the PS sensor is configured to provide a signal for use in detecting PS, and the controller is operably connected to the cardiac pace generator to operate in a pacing configuration to generate cardiac paces,

wherein the controller is configured to;

perform a base test when the cardiac pace generator is operating in the pacing configuration, including;

monitor the signal provided from the PS sensor, including detect an amplitude of the monitored signal provided from the PS sensor,

compare the sensed amplitude to a threshold to detect PS, and

provide a trigger when the sensed amplitude is higher than the threshold which indicates a PS detection from the monitored signal provided from the PS sensor;

respond to the trigger from the base test, wherein respond to the trigger includes;

store a portion of the signal from the PS sensor in the memory of the IMD when the cardiac pace generator is operating in the pacing configuration, wherein the stored portion is more than was used by the base test, the stored portion including N beats where a beat is a signal from the PS sensor associated with a cardiac pace; and

analyze the stored portion of the signal including determining that M of N beats indicate PS to confirm the PS detection from the base test, thereby providing a confirmed PS detection having a higher level of confidence than provided by the base test that PS is detected; and

record, based on the confirmed PS detection, that PS is detected in the memory storage within the IMD.

2. The system of claim 1, wherein the controller is further configured to respond to the confirmed PS detection, including further analyze the signal from the PS sensor using a different PS detection test to provide further confirmation of the PS detection and thereby provide an even higher level of confidence that PS is detected than was provided by analyzing more of the signal from the PS sensor.

3. The system of claim 1, wherein the controller is further configured to respond and to the confirmed PS detection, including analyze the signal from the PS sensor for each potential pacing configuration in two or more potential pacing configurations to determine if PS is present in the two or more potential pacing configurations.

4. The system of claim 3, wherein each of the two or more potential pacing configurations have a different cathode, wherein the controller is configured to, in response to the confirmed PS detection, analyze the signal from the PS sensor for each cathode of the potential pacing configurations.

5. The system of claim 3, wherein the two or more potential pacing configurations are a programmed subset of IMD pacing configurations.

6. The system of claim 3, wherein the controller is configured to determine a PS threshold in each of the two or more potential pacing configurations.

7. The system of claim 1, wherein the controller is configured to automatically change a current pacing configuration to another pacing configuration based at least in part on PS detection.

8. The system of claim 1, wherein the controller is configured to communicate an alert to an external device based at least in part on PS detection.

9. The system of claim 1, wherein the PS sensor includes an accelerometer.

10. A system, comprising:

an implantable medical device (IMD) for implantation in a patient, the IMD including a cardiac pace generator, a memory, a controller and a phrenic nerve stimulation (PS) sensor including an accelerometer, wherein the PS sensor is configured to provide a signal for use in detecting PS, and the controller is operably connected to the cardiac pace generator to operate in a pacing configuration to generate cardiac paces, wherein the controller is configured to;

perform a base test when the cardiac pace generator is operating in the pacing configuration, including;

monitor the signal provided from the PS sensor, including detect an amplitude of the monitored signal provided from the PS sensor,

compare the sensed amplitude to a threshold to detect PS, and provide a trigger when the sensed amplitude is higher than the threshold which indicates a PS detection from the monitored signal provided from the PS sensor;

respond to the trigger from the base test, wherein respond to the trigger includes;

store a portion of the signal from the PS sensor in the memory of the IMD when the cardiac pace generator is operating in the pacing configuration, wherein the stored portion that is more than was used by the base test , the stored portion including N beats where a beat is a signal from the PS sensor associated with a cardiac pace; and

analyze the stored portion of the signal including determining that M of N beats indicate PS, thereby providing a confirmed PS detection, having a higher level of confidence than provided by the base test that PS is detected;

respond to the confirmed PS detection, including further analyze the signal from the PS sensor using a different PS detection test to provide greater confidence that PS is detected; and

record, based on the confirmed PS detection, PS detection in the memory storage within the IMD and;

automatically change a current pacing configuration to another pacing configuration based at least in part on the confirmed PS detection;

or

communicate an alert to an external device based at least in part on the confirmed PS detection.

11. The system of claim 10, wherein the controller is configured to respond to a user input to selectively skip the further analysis of the signal from the PS sensor or to selectively skip both the analysis and the further analysis of the signal from the PS sensor.

12. A system, comprising:

an implantable medical device (IMD) for implantation in a patient, the IMD including a cardiac pace generator, phrenic nerve stimulation (PS) sensor, a memory, and a controller, wherein the PS sensor is configured to provide a signal for use in detecting PS, and the controller is operably connected to the cardiac pace generator to operate in a pacing configuration to generate cardiac paces,

wherein the controller is configured to;

perform a base test when the cardiac pace generator is operating in the pacing configuration, including;

monitor the signal provided from the PS sensor, including detect an amplitude of the monitored signal provided from the PS sensor,

compare the sensed amplitude to a threshold to detect PS, and

provide a trigger when the sensed amplitude is higher than the threshold which indicates a PS detection from the monitored signal provided from the PS sensor;

respond to the trigger from the base test, wherein respond to the trigger includes;

store a portion of the signal from the PS sensor in the memory of the IMD when the cardiac pacing generator is operating in the pacing configuration, wherein the stored portion is more than was used by the base test, the stored portion including N beats where a beat is a signal from the PS sensor associated with a cardiac pace; and

analyze the stored portion of the signal including determining that M of N beats are consistent with PS to confirm the PS detection from the base test, thereby providing a confirmed PS detection having a higher level of confidence than provided by the base test that PS is detected; and

record, based on the confirmed PS detection, that PS is detected in the memory storage within the IMD and

automatically change a current pacing configuration to another pacing configuration based at least in part on the confirmed PS detection.

13. The system of claim 12, wherein the controller is further configured to respond to the confirmed PS detection, including further analyze the signal from the PS sensor to provide further confirmation of the PS detection and thereby provide an even higher level of confidence that PS is detected than was provided by analyzing more of the signal from the PS sensor.

14. The system of claim 13, wherein the controller is configured to determine a PS threshold in each of the two or more potential pacing configurations.

15. The system of claim 12, wherein the controller is further configured to respond to the confirmed PS detection, including analyze the signal from the PS sensor for each potential pacing configuration in two or more potential pacing configurations to determine if PS is present in the two or more potential pacing configurations.

16. The system of claim 15, wherein each of the two or more potential pacing configurations have a different cathode, wherein the controller is configured to respond to the confirmed PS detection, including analyze the signal from the PS sensor for each cathode of the potential pacing configurations.

17. The system of claim 15, wherein the two or more potential pacing configurations are a programmed subset of IMD pacing configurations.

18. The system of claim 12, wherein the controller is configured to communicate an alert to an external device based at least in part on PS detection.