Method and apparatus for phrenic stimulation detection

• US 8,649,866 B2
• Filed: 02/10/2009
• Issued: 02/11/2014
• Est. Priority Date: 02/14/2008
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Brooke, M. Jason
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US12/368,828
• Publication Number:
  US 20090210024A1
• Time in Patent Office: 1,827 Days
• Field of Search: 607/9, 607/17, 607/19, 607/20, 600/595, 600/484
• US Class Current: 607/28
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• 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 5/283 Invasive
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4029 for evaluating the peripheral nervous systems A61B5/24 takes precedence
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators

Abstract

Approaches for characterizing a phrenic stimulation threshold, a cardiac capture threshold, a maximum device parameter, and a minimum device parameter are described. A plurality of cardiac pacing pulses can be delivered by using a cardiac pacing device, a pacing parameter of the plurality of cardiac pacing pulses being changed between delivery of at least some of the pulses. One or more sensor signals can be evaluated to detect stimulation of the phrenic nerve by one or more of the plurality of cardiac pacing pluses. The evaluation of the one or more sensor signals and the pacing parameter can be compared to determine if a phrenic stimulation threshold is at least one of higher than a maximum device parameter and lower than a minimum device parameter.

Claims

1. A cardiac rhythm management system, comprising:

an implantable cardiac pacing device having a plurality of electrodes;

circuitry configured to output a plurality of cardiac pacing pulses through the electrodes, the plurality of cardiac pacing pulses being dependent on one or more pacing parameters;

and

a controller configured to determine a phrenic stimulation threshold based, at least in part, on the one or more signals indicative of sensed phrenic stimulation, and store information based on the determination, wherein when determining the phrenic stimulation threshold, the controller increasing a pacing parameter for one or more of the plurality of cardiac pacing pulses between delivery of at least some of the plurality of pacing pulses until the phrenic stimulation threshold is detected or a cardiac pacing pulse is delivered at a maximum amplitude and/or width that the cardiac pacing device is programmed to deliver.

2. The cardiac rhythm management system of claim 1, wherein the controller is further configured to execute stored program instructions to cause the system to deliver an initial pacing pulse through the electrodes having an amplitude and/or width at or above a cardiac capture threshold and increase the pacing pulse amplitude and/or width for one or more of the plurality of cardiac pacing pulses between delivery of at least some of the plurality of pulses until at least one of the phrenic stimulation threshold is detected and a cardiac pacing pulse is delivered at maximum amplitude and/or width that the cardiac pacing device is programmed to deliver.

3. The cardiac rhythm management system of claim 1, wherein the controller is further configured to execute stored program instructions to cause the system to deliver an initial pacing pulse having an amplitude and/or width at a programmed minimum level and increase the pacing pulse amplitude and/or width for one or more of the plurality of cardiac pacing pulses between delivery of at least some of the plurality of pulses until at least one of the phrenic stimulation threshold is detected and a cardiac pacing pulse is delivered at maximum amplitude and/or width that the cardiac pacing device is programmed to deliver.

4. The cardiac rhythm management system of claim 1, wherein the controller is further configured to execute stored program instructions to cause the system to decrease a pacing pulse amplitude and/or width parameter for one or more of the plurality of cardiac pacing pulses between delivery of at least some of the plurality of pulses until the pacing pulse amplitude and/or width parameter is decreased to at least one of a the cardiac capture threshold and a minimum cardiac pacing amplitude and/or width parameter that the cardiac pacing device is programmed to deliver.

5. The cardiac rhythm management system of claim 1, wherein the controller is further configured to execute stored program instructions to cause the system to identify relative relationships between each of the phrenic stimulation threshold, a maximum cardiac pacing parameter, a minimum cardiac pacing parameter, and a cardiac capture threshold.

6. The cardiac rhythm management system of claim 5, wherein the controller is further configured to execute stored program instructions to cause the system to select a pulse amplitude and/or width parameter range for delivering cardiac pacing pulses associated with a therapy, the pulse amplitude and/or width parameter range selection based on the identified relationships between the phrenic stimulation threshold, the maximum cardiac pacing parameter, the minimum cardiac pacing parameter, and the cardiac capture threshold.

7. The cardiac rhythm management system of claim 1, wherein the controller is further configured to execute stored program instructions to cause the system to reprogram one or both of a maximum cardiac pacing parameter and a minimum cardiac pacing parameter based on a determination that the phrenic stimulation threshold is at least one of higher than the maximum cardiac pacing parameter and lower than the minimum cardiac pacing parameter.

8. The cardiac rhythm management system of claim 1, wherein the controller is further configured to execute stored program instructions to cause the system to select a parameter range limit comprising a maximum cardiac pacing parameter and a minimum cardiac pacing parameter, and deliver at least one of the plurality of cardiac pacing pulses with a pacing parameter that is outside of the parameter range limit.

9. The cardiac rhythm management system of claim 8, wherein the controller is further configured to execute stored program instructions to cause the system to change the parameter range limit based, at least in part, on the one or more signals indicative of sensed phrenic stimulation and the pacing parameter of the at least one of the plurality of cardiac pacing pulses with the pacing parameter that is outside of the parameter range limit.

10. The cardiac rhythm management system of claim 1, wherein the controller is further configured to execute stored program instructions to cause the system to change one or both of an increment value and a decrement value for a pacing parameter that is changed between delivery of at least some of the plurality of pacing pulses.

11. A cardiac rhythm management system, comprising:

an implantable cardiac pacing device having a plurality of electrodes;

means for delivering a plurality of cardiac pacing pulses through the plurality of electrodes, the plurality of cardiac pacing pulses being dependent on one or more pacing parameters;

signal processing means in communication with means for sensing stimulation of the phrenic nerve by one or more of the plurality of pacing pulses and for providing one or more signals indicative of sensed phrenic stimulation; and

means for determining a phrenic stimulation threshold based, at least in part, on the one or more signals indicative of the sensed phrenic stimulation, the means for determining the phrenic stimulation threshold increasing a pacing parameter for one or more of the plurality of cardiac pacing pulses between delivery of at least some of the plurality of pacing pulses until the phrenic stimulation threshold is detected or a cardiac pacing pulse is delivered at a maximum amplitude and/or width that the cardiac pacing device is set to deliver.

12. A cardiac rhythm management system, comprising:

an implantable cardiac pacing device having a plurality of electrodes;

circuitry configured to output a plurality of cardiac pacing pulses through the electrodes, the plurality of cardiac pacing pulses being dependent on one or more pacing parameters;

a signal processor in communication with one or more sensors configured to sense for stimulation of the phrenic nerve by one or more of the plurality of pacing pulses and to produce one or more signals indicative of phrenic stimulation; and

a controller configured to receive the one or more signals indicative of phrenic stimulation and to execute program instructions stored in memory to cause the system to compare the one or more signals indicative of phrenic stimulation and the one or more pacing parameters to identify relative relationships between each of a phrenic stimulation threshold, a maximum cardiac pacing parameter that the cardiac device is set to deliver, and a minimum cardiac pacing parameter that the cardiac device is set to deliver.

13. The cardiac rhythm management system of claim 12, wherein the maximum cardiac pacing parameter is a maximum pacing pulse amplitude and/or width that the cardiac pacing device is programmed to deliver and the minimum cardiac pacing parameter is a minimum pacing pulse amplitude and/or width that the cardiac pacing device is programmed to deliver.

14. The cardiac rhythm management system of claim 12, wherein the controller is further configured to execute stored program instructions to cause the system to increase a pacing pulse amplitude and/or width parameter for one or more of the plurality of cardiac pacing pulses between delivery of at least some of the plurality of pulses until at least one of the phrenic stimulation threshold is detected and a cardiac pacing pulse is delivered at maximum amplitude and/or width that the cardiac pacing device is programmed to deliver.

15. The cardiac rhythm management system of claim 12, wherein the controller is further configured to execute stored program instructions to cause the system to deliver an initial pacing pulse through the electrodes having an amplitude and/or width at or above a cardiac capture threshold and increase the pacing pulse amplitude and/or width for one or more of the plurality of cardiac pacing pulses between delivery of at least some of the plurality of pulses until at least one of the phrenic stimulation threshold is detected and a cardiac pacing pulse is delivered at maximum amplitude and/or width that the cardiac pacing device is programmed to deliver.

16. The cardiac rhythm management system of claim 12, wherein the controller is further configured to execute stored program instructions to cause the system to deliver an initial pacing pulse having an amplitude and/or width at a programmed minimum level and increase the pacing pulse amplitude and/or width for one or more of the plurality of cardiac pacing pulses between delivery of at least some of the plurality of pulses until at least one of the phrenic stimulation threshold is detected and a cardiac pacing pulse is delivered at maximum amplitude and/or width that the cardiac pacing device is programmed to deliver.

17. The cardiac rhythm management system of claim 12, wherein the controller is further configured to execute stored program instructions to cause the system to decrease a pacing pulse amplitude and/or width parameter for one or more of the plurality of cardiac pacing pulses between delivery of at least some of the plurality of pulses until the pacing pulse amplitude and/or width parameter is decreased to at least one of a cardiac capture threshold and the minimum cardiac pacing amplitude and/or width parameter that the cardiac pacing device is programmed to deliver.

18. The cardiac rhythm management system of claim 12, wherein the controller is further configured to execute stored program instructions to cause the system to further identify relative relationships between each of the phrenic stimulation threshold, the maximum cardiac pacing parameter, the minimum cardiac pacing parameter, and a cardiac capture threshold.

19. The cardiac rhythm management system of claim 18, wherein the controller is further configured to execute stored program instructions to cause the system to select a pulse amplitude and/or width parameter range for delivering cardiac pacing pulses associated with a therapy, the pulse amplitude and/or width parameter range selection based on the identified relationships between the phrenic stimulation threshold, the maximum cardiac pacing parameter, the minimum cardiac pacing parameter, and the cardiac capture threshold.

20. The cardiac rhythm management system of claim 12, wherein the controller is further configured to execute stored program instructions to cause the system to reprogram one or both of the maximum cardiac pacing parameter and the minimum cardiac pacing parameter based on a determination that the phrenic stimulation threshold is at least one of higher than the maximum cardiac pacing parameter and lower than the minimum cardiac pacing parameter.

21. The cardiac rhythm management system of claim 12, wherein the controller is further configured to execute stored program instructions to cause the system to select a parameter range limit comprising the maximum cardiac pacing parameter and the minimum cardiac pacing parameter and deliver at least one of the plurality of cardiac pacing pulses with a pacing parameter that is outside of the parameter range limit.

22. The cardiac rhythm management system of claim 21, wherein the controller is further configured to execute stored program instructions to cause the system to change the parameter range limit based on the comparison of the one or more sensor signals and the pacing parameter of the at least one cardiac pacing pulses with the pacing parameter that is outside of the parameter range limit.

23. The cardiac rhythm management system of claim 12, wherein the controller is further configured to execute stored program instructions to cause the system to change one or both of an increment value and a decrement value for the pacing parameter of the plurality of cardiac pacing pulses that is changed between delivery of at least some of the pulses based on the comparison of the one or more sensor signals and the pacing parameter of one or more of the plurality of cardiac pacing pulses.