Baseline determination for phrenic nerve stimulation detection

• US 10,413,203 B2
• Filed: 02/28/2013
• Issued: 09/17/2019
• Est. Priority Date: 03/27/2012
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Saha, Sunipa, Dong, Yanting, Rockweiler, Holly
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): Portillo, Jairo H
• Application Number:
  US13/781,133
• Publication Number:
  US 20130261471A1
• Time in Patent Office: 2,392 Days
• Field of Search: 600484, 607 9, 607 28
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• 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 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4052 efferent nerves, i.e. nerves that relay impulses from the central nervous system
• 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: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation

Abstract

Some method examples may include pacing a heart with cardiac paces, sensing a physiological signal for use in detecting pace-induced phrenic nerve stimulation, performing a baseline level determination process to identify a baseline level for the sensed physiological signal, and detecting pace-induced phrenic nerve stimulation using the sensed physiological signal and the calculated baseline level. Detecting pace-induced phrenic nerve stimulation may include sampling the sensed physiological signal during each of a plurality of cardiac cycles to provide sampled signals and calculating the baseline level for the physiological signal using the sampled signals. Sampling the sensed physiological signal may include sampling the signal during a time window defined using a pace time with each of the cardiac cycles to avoid cardiac components and phrenic nerve stimulation components in the sampled signal.

Claims

1. A method, comprising:

detecting pace-induced phrenic nerve stimulation using a sensed physiological signal, wherein the pace-induced phrenic nerve stimulation is phrenic nerve stimulation induced by cardiac paces, wherein the detecting pace-induced phrenic nerve stimulation includes;

sampling the sensed physiological signal that is used to detect pace-induced phrenic nerve stimulation during each of a plurality of cardiac cycles to provide a plurality of sampled signals corresponding to the plurality of cardiac cycles, wherein sampling the sensed physiological signal includes;

identifying a pace time window for each of the cardiac cycles to avoid cardiac components and phrenic nerve stimulation components; and

sampling the sensed physiological signal that is used to detect pace-induced phrenic nerve stimulation during the pace time window to provide sampled signals, wherein the sampled signals during the pace time window do not have cardiac components and phrenic nerve stimulation components;

calculating a baseline level for the sensed physiological signal that is used to detect pace-induced phrenic nerve stimulation using the plurality of sampled signals corresponding to the plurality of cardiac cycles; and

detecting pace-induced phrenic nerve stimulation using the sensed physiological signal and the calculated baseline level; and

changing a pacing configuration for pacing the heart in response to detected pace-induced phrenic nerve stimulation.

2. The method of claim 1, further comprising storing the plurality of sampled signals corresponding to the plurality of cardiac cycles in a queue, wherein calculating the baseline level includes the plurality of sampled signals stored in the queue are used to calculate the baseline level, the method further comprising sampling the sensed physiological signal during subsequent cardiac cycles to provide subsequent sampled signals, and dynamically adjusting the baseline level for the physiological signal using the subsequent sampled signals.

3. The method of claim 1, wherein the sensed physiological signal includes an accelerometer signal.

4. The method of claim 1, wherein the sensed physiological signal includes a signal selected from a group of signals consisting of:

an acoustic sensor, a respiration sensor, impedance sensors, a neural sensor on the phrenic nerve, and electrodes to sense electromyogram signals indicative of diaphragm contraction.

5. The method of claim 1, wherein calculating the baseline level includes determining peak-to-peak amplitudes of the sampled signals.

6. The method of claim 1, wherein sampling the sensed physiological signal during the time window includes sampling the sensed physiological signal during the cardiac cycle for a time period beginning before the pace time and ending after the pace time.

7. The method of claim 6, wherein sampling the sensed physiological signal during the cardiac cycle for the time period includes sampling the sensed physiological signal beginning about 100 ms before a left ventricular (LV) pace time and ending about 10 ms after the LV pace time.

8. The method of claim 1, further comprising identifying noisy sampled signals and removing noisy sampled signals from the plurality of sampled signals that are used to calculate the baseline level.

9. The method of claim 1, further comprising determining if sampled signals are offset outside of an upper bound or a lower bound, and adjusting the sampled signals that are offset to correct for the offset.

10. The method of claim 1, further comprising identifying outlier sampled signals using statistical analysis, and removing the outlier sampled signals from the plurality of sampled signals that are used to calculate the baseline level.

11. The method of claim 1, wherein detecting pace-induced phrenic nerve stimulation using the sensed physiological signal and the calculated baseline level includes:

monitoring a beat signal within the sensed physiological signal, wherein the beat signal is within a defined window of time that is defined using the pace time;

identifying characteristics of the beat signal;

comparing the characteristics of the beat signal to the baseline; and

determining if the beat signal is a PS beat or a NoPS beat based on the comparison, wherein PS beats are determined to include a pace-induced phrenic nerve stimulation response and NoPS beats are determined to not include the pace-induced phrenic nerve stimulation response.

12. The method of claim 1, further comprising:

triggering a baseline level determination process according to a schedule or a sensed context or a patient-initiated or clinician-initiated command, wherein the baseline level determination process includes calculating a baseline level for the physiological signal using the sampled signals.

13. A method, comprising:

pacing a heart with cardiac paces;

sensing a physiological signal for use in detecting pace-induced phrenic nerve stimulation, wherein the pace-induced phrenic nerve stimulation is phrenic nerve stimulation induced by the cardiac paces;

performing a baseline level determination process to identify a baseline level for the sensed physiological signal, including;

sampling the sensed physiological signal during each of a plurality of cardiac cycles to provide a plurality of sampled signals corresponding to the plurality of cardiac cycles, wherein sampling the sensed physiological signal includes identifying a pace time window in each of the cardiac cycles to avoid cardiac components and phrenic nerve stimulation components and sampling the signal during the pace time window to provide sampled signals, wherein the sampled signals during the pace time window do not have cardiac components and phrenic nerve stimulation components; and

calculating the baseline level for the sensed physiological signal that is used to detect pace-induced phrenic nerve stimulation using the plurality of sampled signals corresponding to the plurality of cardiac cycles;

detecting pace-induced phrenic nerve stimulation using the sensed physiological signal and the calculated baseline level; and

changing a pacing configuration for pacing the heart in response to detected pace-induced phrenic nerve stimulation.

14. The method of claim 13, wherein the method is performed using an implantable medical device in an ambulatory patient away from a clinical setting.

15. The method of claim 14, wherein changing the pacing configuration includes changing the pacing configuration in the ambulatory patient away from the clinical setting.

16. The method of claim 13, wherein the method is performed in a clinical setting.

17. The method of claim 13, wherein an external system is used to sense the physiological signal, perform the baseline level determination process, and detect pace-induced phrenic nerve stimulation.

18. A system comprising a phrenic nerve stimulation detector configured to detect a pace-induced phrenic nerve stimulation using a sensed physiological signal, wherein the phrenic nerve stimulation detector is configured to:

identify a pace time window with each of the cardiac cycles to avoid cardiac components and phrenic nerve stimulation components;

sample the sensed physiological signal that is used to detect pace-induced phrenic nerve stimulation during the pace time window to provide a plurality of sampled signals corresponding to the plurality of cardiac cycles, wherein the sampled signals during the pace time window do not have cardiac components and phrenic nerve stimulation components;

calculate a baseline level for the sensed physiological signal that is used to detect pace-induced phrenic nerve stimulation using the plurality of sampled signals corresponding to the plurality of cardiac cycles;

detect pace-induced phrenic nerve stimulation using the sensed physiological signal and the calculated baseline level; and

change a pacing configuration for pacing the heart in response to detected pace-induced phrenic nerve stimulation,

wherein the phrenic nerve stimulation detector includes a memory for storing a queue of sampled signals, the phrenic nerve stimulation detector is configured to store the sampled signals in the queue and calculate the baseline level using the sampled signals stored in the queue, the phrenic nerve stimulation detector is configured to sample the sensed physiological signal during subsequent cardiac cycles to move subsequent sampled signals into the queue, and dynamically adjust the baseline level for the physiological signal using the subsequent sampled signals in the queue.

19. The system of claim 18, further comprising a cardiac pulse generator configured to generate cardiac paces to pace the heart;

and

a sensor configured to sense the physiological signal, wherein the pace-induced phrenic nerve stimulation is phrenic nerve stimulation induced by electrical cardiac pace signals.

20. The system of claim 19, wherein the system includes at least one implantable medical device, including the cardiac pulse generator, the sensor and the phrenic nerve detector.