Methods for setting cardiac pacing parameters in relatively high efficiency pacing systems

• US 8,626,294 B2
• Filed: 07/29/2011
• Issued: 01/07/2014
• Est. Priority Date: 07/29/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sheldon, Todd J., Demmer, Wade M.
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US13/193,783
• Publication Number:
  US 20130030493A1
• Time in Patent Office: 893 Days
• Field of Search: 607/4, 607/9, 607 27- 28
• US Class Current: 607/28
• CPC Class Codes: A61N 1/3708 for power depletion
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

According to some methods, for example, preprogrammed in a microprocessor element of an implantable cardiac pacing system, at least one of a number of periodic pacing threshold searches includes steps to reduce an evoked response amplitude threshold for evoked response signal detection. The reduction may be to a minimum value measurable above zero, for example, as determined by establishing a ‘noise floor’. Alternately, amplitudes of test pacing pulses and corresponding post pulse signals are collected and reviewed to search for a break, to determine a lower value to which the evoked response threshold may be adjusted without detecting noise. Subsequent to reducing the threshold, if no evoked response signal is detected for a test pulse applied at or above a predetermined maximum desirable pulse energy, an operational pacing pulse energy is set to greater than or equal to the maximum desirable in conjunction with a reduction in pacing rate.

Claims

1. In an implanted cardiac pacing system, a method for setting pacing parameters comprising:

conducting periodic pacing threshold searches, wherein at least one of the periodic pacing threshold searches comprises;

applying a series of test pacing pulses at incremented and/or decremented levels of pulse energy;

adjusting an initial evoked response amplitude threshold for evoked response signal detection to a lower value when, upon applying a test pacing pulse, no evoked response signal is detected at the initial threshold; and

restarting the pacing threshold search with the lower value for the evoked response amplitude threshold;

setting an operational pacing pulse energy greater than or equal to a predetermined maximum desirable pulse energy, when no evoked response signal is detected with the lower evoked response amplitude threshold when another test pulse is applied at or above the predetermined maximum desirable pulse energy during the pacing threshold search; and

reducing a pacing rate following the pacing threshold search of the periodic pacing threshold searches, when the operational pacing pulse energy is set greater than the predetermined maximum desirable pulse energy.

2. The method of claim 1, wherein the applied test pacing pulse that triggers the adjusting of the initial evoked response amplitude threshold has an energy level above the predetermined maximum desirable pulse energy of the levels of pulse energy.

3. The method of claim 1, wherein the lower value for the evoked response amplitude threshold is a minimum value measurable above zero.

4. The method of claim 3, further comprising generating a warning signal in response to adjusting the initial evoked response amplitude threshold to the lower value.

8. The method of claim 1, further comprising generating a warning signal in response to reducing the pacing rate.

9. In an implanted cardiac pacing system, a method for setting pacing parameters comprising:

conducting periodic pacing threshold searches, wherein at least one of the periodic pacing threshold searches comprises;

applying a series of test pacing pulses at incremented and/or decremented levels of pulse energy;

adjusting an initial evoked response amplitude threshold for evoked response signal detection to a lower value when, upon applying a test pacing pulse, no evoked response signal is detected at the initial threshold; and

restarting the pacing threshold search with the lower value for the evoked response amplitude threshold;

setting an operational pacing pulse energy greater than or equal to a predetermined maximum desirable pulse energy, when no evoked response signal is detected with the lower evoked response amplitude threshold when another test pulse is applied at or above the predetermined maximum desirable pulse energy during the pacing threshold search; and

reducing a pacing rate following the pacing threshold search of the periodic pacing threshold searches, when the operational pacing pulse energy is set greater than the predetermined maximum desirable pulse energy; and

wherein, when the pacing rate is reduced following the at least one pacing threshold search, the method further comprises;

conducting successive pacing threshold searches of the periodic pacing threshold searches according to the steps of claim 1; and

generating a warning signal, when the pacing rate is reduced following at least two of the successive pacing threshold searches.

10. The method of claim 1, wherein, when the pacing rate is reduced following the at least one pacing threshold search, then the method further comprises:

conducting a successive pacing threshold search of the periodic pacing threshold searches according to the steps of claim 1; and

setting the operational pacing pulse energy to less than or equal to the maximum desirable pulse energy and increasing the pacing rate, when an evoked response signal is detected at the lower threshold in the successive pacing threshold search.

11. The method of claim 1, wherein the operational pacing pulse energy is set equal to the predetermined maximum desirable pulse energy, when no evoked response signal is detected at the lower threshold when the other test pulse is applied above the predetermined maximum desirable pulse energy during the pacing threshold search.

5. In an implanted cardiac pacing system, a method for setting pacing parameters comprising:

conducting periodic pacing threshold searches, wherein at least one of the periodic pacing threshold searches comprises;

applying a series of test pacing pulses at incremented and/or decremented levels of pulse energy;

adjusting an initial evoked response amplitude threshold for evoked response signal detection to a lower value when, upon applying a test pacing pulse, no evoked response signal is detected at the initial threshold; and

restarting the pacing threshold search with the lower value for the evoked response amplitude threshold;

setting an operational pacing pulse energy greater than or equal to a predetermined maximum desirable pulse energy, when no evoked response signal is detected with the lower evoked response amplitude threshold when another test pulse is applied at or above the predetermined maximum desirable pulse energy during the pacing threshold search; and

reducing a pacing rate following the pacing threshold search of the periodic pacing threshold searches, when the operational pacing pulse energy is set greater than the predetermined maximum desirable pulse energy; and

wherein the pacing threshold search further comprises;

collecting an amplitude of each test pacing pulse and corresponding potential evoked response signal, during the applied series of test pacing pulses; and

wherein adjusting the initial evoked response amplitude threshold comprises processing the collected amplitudes to search for a break between a first potential evoked response signal amplitude associated with a first test pacing pulse of the series and a second potential evoked response signal amplitude associated with a second test pacing pulse of the series, the first and second test pacing pulses having pacing energies adjacent one another; and

the lower value of the evoked response amplitude threshold is greater than a value of the lower of the first and second potential evoked response signal amplitudes and less than or equal to a value of the higher of the first and second potential evoked response signal amplitudes.

6. In an implanted cardiac pacing system, a method for setting pacing parameters comprising:

conducting periodic pacing threshold searches, wherein at least one of the periodic pacing threshold searches comprises;

applying a series of test pacing pulses at incremented and/or decremented levels of pulse energy;

adjusting an initial evoked response amplitude threshold for evoked response signal detection to a lower value when, upon applying a test pacing pulse, no evoked response signal is detected at the initial threshold; and

restarting the pacing threshold search with the lower value for the evoked response amplitude threshold;

setting an operational pacing pulse energy greater than or equal to a predetermined maximum desirable pulse energy, when no evoked response signal is detected with the lower evoked response amplitude threshold when another test pulse is applied at or above the predetermined maximum desirable pulse energy during the pacing threshold search; and

reducing a pacing rate following the pacing threshold search of the periodic pacing threshold searches, when the operational pacing pulse energy is set greater than the predetermined maximum desirable pulse energy; and

wherein restarting the pacing threshold search with the lower value for the evoked response amplitude threshold comprises;

collecting an amplitude of each test pacing pulse and corresponding potential evoked response signal, during the applied series of test pacing pulses;

processing the collected amplitudes to search for a break between a first potential evoked response amplitude associated with a first test pacing pulse of the series and a second potential evoked response signal amplitude associated with a second test pacing pulse of the series, the first and second test pacing pulses having pulse energies adjacent one another;

further adjusting the lower value of the evoked response amplitude threshold to an even lower value, when the break is found, the even lower value being greater than a value of the lower of the first and second potential evoked response signal amplitudes; and

restarting the pacing threshold search with the even lower value of the evoked response amplitude threshold, when the lower value is adjusted.

7. The method of claim 6, wherein the pacing threshold search further comprises establishing the even lower value of the evoked response amplitude threshold as the initial value of the evoked response amplitude threshold for a successive pacing threshold search, if the lower value is adjusted.

12. An implantable cardiac pacing system configured to be wholly implanted against an endocardial or epicardial surface, the system including a pulse generator having a microprocessor element being preprogrammed to direct the pulse generator to carry out a method comprising the following steps:

conducting periodic pacing threshold searches, wherein at least one of the periodic pacing threshold search comprises;

applying a series of test pacing pulses at incremented and/or decremented levels of pulse energy;

adjusting an initial evoked response amplitude threshold to a lower value, when, upon applying a test pacing pulse, no evoked response signal is detected at the initial threshold; and

restarting the pacing threshold search with the lower value for the evoked response amplitude threshold, when the initial threshold is adjusted;

generating a first command signal to set an operational pacing pulse energy greater than or equal to the predetermined maximum desirable pulse energy, when no evoked response signal is detected with the lower evoked response amplitude threshold, when another test pulse is applied at or above a predetermined maximum desirable pulse energy during the pacing threshold search; and

generating a second command signal to reduce a pacing rate following a pacing threshold search of the periodic pacing threshold searches, when the operational pacing pulse energy is set greater than the predetermined maximum desirable pulse energy.

13. The system of claim 12, wherein the applied test pacing pulse that triggers the adjusting the initial evoked response amplitude threshold has an energy level above a predetermined maximum desirable pulse energy of the levels of pulse energy.

14. The system of claim 12, wherein the lower value for the evoked response amplitude threshold is a minimum value measurable above zero.

15. The system of claim 14, wherein the method further comprises generating a warning signal in response to adjusting the initial evoked response amplitude threshold to the lower value.

19. The system of claim 12, wherein the method further comprises generating a warning signal in response to generating the second command signal to reduce the pacing rate.

21. The system of claim 12, wherein the method further comprises:

conducting a successive pacing threshold search of the periodic pacing threshold searches with the lower value for the evoked response amplitude threshold, when the second command was generated to reduce the pacing rate; and

generating another pair of command signals to set the operational pacing pulse energy less than or equal to the maximum desirable pulse energy and to increase the pacing rate, when an evoked response signal is detected at the lower threshold in the successive pacing threshold search.

22. The system of claim 12, wherein the method further comprises executing the at least one of the periodic pacing threshold searches according to the method of claim 12, only if a prior pacing threshold search results in the operational pacing pulse energy being set at the predetermined maximum desirable pulse energy.

16. An implantable cardiac pacing system configured to be wholly implanted against an endocardial or epicardial surface, the system including a pulse generator having a microprocessor element being preprogrammed to direct the pulse generator to carry out a method comprising the following steps:

conducting periodic pacing threshold searches, wherein at least one of the periodic pacing threshold search comprises;

applying a series of test pacing pulses at incremented and/or decremented levels of pulse energy;

adjusting an initial evoked response amplitude threshold to a lower value, when, upon applying a test pacing pulse, no evoked response signal is detected at the initial threshold; and

restarting the pacing threshold search with the lower value for the evoked response amplitude threshold, when the initial threshold is adjusted;

generating a first command signal to set an operational pacing pulse energy greater than or equal to the predetermined maximum desirable pulse energy, when no evoked response signal is detected with the lower evoked response amplitude threshold, when another test pulse is applied at or above a predetermined maximum desirable pulse energy during the pacing threshold search; and

generating a second command signal to reduce a pacing rate following a pacing threshold search of the periodic pacing threshold searches, when the operational pacing pulse energy is set greater than the predetermined maximum desirable pulse energy; and

wherein the pacing threshold search further comprises;

collecting an amplitude of each test pacing pulse and corresponding potential evoked response signal, during the applied series of test pacing pulses; and

wherein adjusting the initial evoked response amplitude threshold to the lower value comprises processing the collected amplitudes to search for a break between a first potential evoked response signal amplitude associated with a first test pacing pulse of the series and a second potential evoked response signal amplitude associated with a second test pacing pulse of the series, the first and second test pacing pulses having pacing energies adjacent one another; and

the lower value of the evoked response amplitude threshold is greater than a value of the lower of the first and second potential evoked response signal amplitudes and less than or equal to a value of the higher of the first and second potential evoked response signal amplitudes.

17. An implantable cardiac pacing system configured to be wholly implanted against an endocardial or epicardial surface, the system including a pulse generator having a microprocessor element being preprogrammed to direct the pulse generator to carry out a method comprising the following steps:

conducting periodic pacing threshold searches, wherein at least one of the periodic pacing threshold search comprises;

applying a series of test pacing pulses at incremented and/or decremented levels of pulse energy;

adjusting an initial evoked response amplitude threshold to a lower value, when, upon applying a test pacing pulse, no evoked response signal is detected at the initial threshold; and

restarting the pacing threshold search with the lower value for the evoked response amplitude threshold, when the initial threshold is adjusted;

generating a first command signal to set an operational pacing pulse energy greater than or equal to the predetermined maximum desirable pulse energy, when no evoked response signal is detected with the lower evoked response amplitude threshold, when another test pulse is applied at or above a predetermined maximum desirable pulse energy during the pacing threshold search; and

generating a second command signal to reduce a pacing rate following a pacing threshold search of the periodic pacing threshold searches, when the operational pacing pulse energy is set greater than the predetermined maximum desirable pulse energy; and

wherein restarting the pacing threshold search with the lower value for the evoked response amplitude threshold comprises;

collecting an amplitude of each test pacing pulse and corresponding potential detected evoked response signal, during the applied series of test pacing pulses;

processing the collected amplitudes to search for a break between a first potential evoked response amplitude associated with a first test pacing pulse of the series and a second potential evoked response signal amplitude associated with a second test pacing pulse of the series, the first and second test pacing pulses having pacing energies adjacent one another;

further adjusting the lower value of the evoked response amplitude threshold to an even lower value, when the break is found, the even lower value being greater than a value of the evoked response amplitude of the lower of the first and second potential evoked response signal amplitudes; and

restarting the pacing threshold search with the even lower value of the evoked response amplitude threshold, when the lower value is adjusted.

18. The system of claim 17, wherein the pacing threshold search further comprises establishing the even lower value for the evoked response amplitude threshold as the initial value of the evoked response amplitude threshold for a subsequent pacing threshold search, when the lower value is adjusted.

20. An implantable cardiac pacing system configured to be wholly implanted against an endocardial or epicardial surface, the system including a pulse generator having a microprocessor element being preprogrammed to direct the pulse generator to carry out a method comprising the following steps:

conducting periodic pacing threshold searches, wherein at least one of the periodic pacing threshold search comprises;

applying a series of test pacing pulses at incremented and/or decremented levels of pulse energy;

adjusting an initial evoked response amplitude threshold to a lower value, when, upon applying a test pacing pulse, no evoked response signal is detected at the initial threshold; and

restarting the pacing threshold search with the lower value for the evoked response amplitude threshold, when the initial threshold is adjusted;

generating a first command signal to set an operational pacing pulse energy greater than or equal to the predetermined maximum desirable pulse energy, when no evoked response signal is detected with the lower evoked response amplitude threshold, when another test pulse is applied at or above a predetermined maximum desirable pulse energy during the pacing threshold search; and

generating a second command signal to reduce a pacing rate following a pacing threshold search of the periodic pacing threshold searches, when the operational pacing pulse energy is set greater than the predetermined maximum desirable pulse energy; and

wherein the method further comprises;

conducting successive pacing threshold searches of the periodic pacing threshold searches with the lower value for the evoked response amplitude threshold, when the second command was generated to reduce the pacing rate; and

generating a warning signal, when the command signals are successively generated such that the pacing rate remains reduced following each of at least two successive pacing threshold searches.

23. An implantable cardiac pacing system configured to be wholly implanted against an endocardial or epicardial surface, the system including a pulse generator having a microprocessor element being preprogrammed to direct the pulse generator to carry out a method comprising the following steps:

conducting periodic pacing threshold searches, wherein at least one of the periodic pacing threshold search comprises;

applying a series of test pacing pulses at incremented and/or decremented levels of pulse energy;

adjusting an initial evoked response amplitude threshold to a lower value, when, upon applying a test pacing pulse, no evoked response signal is detected at the initial threshold; and

restarting the pacing threshold search with the lower value for the evoked response amplitude threshold, when the initial threshold is adjusted;

generating a first command signal to set an operational pacing pulse energy greater than or equal to the predetermined maximum desirable pulse energy, when no evoked response signal is detected with the lower evoked response amplitude threshold, when another test pulse is applied at or above a predetermined maximum desirable pulse energy during the pacing threshold search; and

generating a second command signal to reduce a pacing rate following a pacing threshold search of the periodic pacing threshold searches, when the operational pacing pulse energy is set greater than the predetermined maximum desirable pulse energy; and

wherein the at least one of the periodic pacing threshold searches comprises no more than three per day.

24. An implantable cardiac pacing system configured to be wholly implanted against an endocardial or epicardial surface, the system including a pulse generator having a microprocessor element being preprogrammed to direct the pulse generator to carry out a method comprising the following steps:

conducting periodic pacing threshold searches, wherein at least one of the periodic pacing threshold search comprises;

applying a series of test pacing pulses at incremented and/or decremented levels of pulse energy;

adjusting an initial evoked response amplitude threshold to a lower value, when, upon applying a test pacing pulse, no evoked response signal is detected at the initial threshold; and

restarting the pacing threshold search with the lower value for the evoked response amplitude threshold, when the initial threshold is adjusted;

generating a first command signal to set an operational pacing pulse energy greater than or equal to the predetermined maximum desirable pulse energy, when no evoked response signal is detected with the lower evoked response amplitude threshold, when another test pulse is applied at or above a predetermined maximum desirable pulse energy during the pacing threshold search; and

generating a second command signal to reduce a pacing rate following a pacing threshold search of the periodic pacing threshold searches, when the operational pacing pulse energy is set greater than the predetermined maximum desirable pulse energy; and

wherein when the at least one of the periodic pacing threshold searches comprises more than one pacing threshold search in one day and, when the initial evoked response amplitude threshold in each of the searches is adjusted to the lower value, the method further comprises generating a warning signal.

25. An implantable cardiac pacing system configured to be wholly implanted against an endocardial or epicardial surface, the system including a pulse generator having a microprocessor element being preprogrammed to direct the pulse generator to carry out a method comprising the following steps:

conducting periodic pacing threshold searches, wherein at least one of the periodic pacing threshold search comprises;

applying a series of test pacing pulses at incremented and/or decremented levels of pulse energy;

adjusting an initial evoked response amplitude threshold to a lower value, when, upon applying a test pacing pulse, no evoked response signal is detected at the initial threshold; and

restarting the pacing threshold search with the lower value for the evoked response amplitude threshold, when the initial threshold is adjusted;

generating a first command signal to set an operational pacing pulse energy greater than or equal to the predetermined maximum desirable pulse energy, when no evoked response signal is detected with the lower evoked response amplitude threshold, when another test pulse is applied at or above a predetermined maximum desirable pulse energy during the pacing threshold search; and

generating a second command signal to reduce a pacing rate following a pacing threshold search of the periodic pacing threshold searches, when the operational pacing pulse energy is set greater than the predetermined maximum desirable pulse energy; and

wherein the first command signal sets the operational pacing pulse energy equal to the predetermined maximum desirable pulse energy, if no evoked response signal is detected at the lower threshold, when the other test pulse is applied above the predetermined maximum desirable pulse energy during the pacing threshold search.

26. In an implanted cardiac pacing system, a method for setting pacing parameters comprising:

conducting periodic pacing threshold searches, wherein at least one of the periodic pacing threshold searches comprises;

applying a series of test pacing pulses at incremented and/or decremented levels of pulse energy;

adjusting an initial evoked response amplitude threshold for evoked response signal detection to a lower value when, upon applying a test pacing pulse, no evoked response signal is detected at the initial threshold; and

restarting the pacing threshold search with the lower value for the evoked response amplitude threshold;

setting an operational pacing pulse energy greater than or equal to a predetermined maximum desirable pulse energy, responsive to no evoked response signal being detected with the lower evoked response amplitude threshold when another test pulse is applied at or above the predetermined maximum desirable pulse energy during the pacing threshold search; and

reducing a pacing rate following the pacing threshold search of the periodic pacing threshold searches, responsive to the operational pacing pulse energy being set greater than the predetermined maximum desirable pulse energy.

27. An implantable cardiac pacing system configured to be wholly implanted against an endocardial or epicardial surface, the system including a pulse generator having a microprocessor element being preprogrammed to direct the pulse generator to carry out a method comprising the following steps:

conducting periodic pacing threshold searches, wherein at least one of the periodic pacing threshold search comprises;

applying a series of test pacing pulses at incremented and/or decremented levels of pulse energy;

adjusting an initial evoked response amplitude threshold to a lower value, when, upon applying a test pacing pulse, no evoked response signal is detected at the initial threshold; and

restarting the pacing threshold search with the lower value for the evoked response amplitude threshold, responsive to the initial threshold being adjusted;

generating a first command signal to set an operational pacing pulse energy greater than or equal to the predetermined maximum desirable pulse energy, responsive to no evoked response signal being detected with the lower evoked response amplitude threshold, when another test pulse is applied at or above a predetermined maximum desirable pulse energy during the pacing threshold search; and

generating a second command signal to reduce a pacing rate following a pacing threshold search of the periodic pacing threshold searches, responsive to the operational pacing pulse energy being set greater than the predetermined maximum desirable pulse energy.