Implantable cardiac stimulation device having autocapture/autothreshold capability

• US 6,430,441 B1
• Filed: 01/18/2000
• Issued: 08/06/2002
• Est. Priority Date: 01/18/2000
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Levine, Paul A.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US09/483,908
• Time in Patent Office: 931 Days
• Field of Search: 607/28, 607/9, 607/11, 607/14, 607/27
• US Class Current: 607/28
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold

Abstract

An improved system and method for performing autocapture/autothreshold detection in an implantable cardiac stimulation device or any device capable of stimulating some organ or tissue in the body. In some existing systems, loss-of-capture and capture decisions are based upon two consecutive cardiac events. However, such systems may be subject to subthreshold stimulation pulses that capture and lose capture on alternating pulses, trigeminy PVC sequences, or the like that require a higher stimulation pulse amplitude but cannot make this determination due to the two consecutive event requirement. Accordingly, in the present invention, the determination of whether there is a loss-of-capture is determined only according to paced events, i.e., ignoring intrinsic and PVC beats. Furthermore, the loss-of-capture determination is based upon X out of the last Y beats, where Y is greater than 2 and X is less than Y. Accordingly, consecutive loss-of-capture events are no longer required in determining the threshold level. In a further aspect, a preferred embodiment monitors cardiac events to detect a sequence of patterns that could indicate a trigeminy pattern and, if detected, the pacing rate is increased to attempt to break the pattern and thus permit the threshold level to be detected.

Claims

1. An implantable cardiac stimulation device for stimulating a patient'"'"'s heart during a cardiac cycle through at least one electrode adapted for electrical contact with selected cardiac tissue, the stimulation device comprising:

a pulse generator electrically coupled to the electrode and configured to generate stimulation pulses at a controlled amplitude and rate to thereby stimulate the patient'"'"'s heart;

a detection circuit electrically coupled to the electrode and configured to receive cardiac signals for determining the presence or absence of an evoked response to each of the stimulation pulses, wherein the detection circuit is further configured to determine the status, for each cardiac cycle, of the presence of an evoked response to each stimulation pulse, the absence of an evoked response to each stimulation pulse, or the presence of an intrinsic cardiac signal without a stimulation pulse; and

a controller coupled to the pulse generator for increasing the stimulation pulse amplitude when a first specified criteria has been met, wherein the first specified criteria is the absence of evoked responses from X out of the last Y stimulation pulses where Y is a value greater than 2 and X is a value less than Y, wherein the controller determines the presence of a predetermined sequence of status determinations from M consecutive cardiac cycles, and further determines the presence of N contiguous occurrences of the specified sequence of M status determinations, wherein the controller is configured to increase the controlled rate in response thereto.

2. The cardiac stimulation device of claim 1 wherein:

the detection circuit detects the presence of an evoked response during a detection time period following each stimulation pulse; and

wherein

the controller causes the pulse generator to generate a backup pulse at the end of each detection time period when an evoked response is not detected.

3. The cardiac stimulation device of claim 2 wherein the backup pulse is set to a predetermined maximum amplitude.

4. An implantable cardiac stimulation device for stimulating a patient'"'"'s heart during a cardiac cycle through at least one electrode adapted for electrical contact with selected cardiac tissue, the stimulation device comprising:

a pulse generator electrically coupled to the electrode and configured to generate stimulation pulses at a controlled amplitude and rate to thereby stimulate the patient'"'"'s heart;

a detection circuit electrically coupled to the electrode and configured to receive cardiac signals for determining the presence or absence of an evoked response to each of the stimulation pulses;

a controller coupled to the pulse generator for increasing the stimulation pulse amplitude when a first specified criteria has been met, wherein the first specified criteria is the absence of evoked responses from X out of the last Y stimulation pulses where Y is a value greater than 2 and X is a value less than Y; and

wherein the controller is configured to periodically adjust the stimulation pulse amplitude by performing a threshold search to determine a stimulation pulse amplitude capable of causing an evoked response, the threshold search including detecting a non-capture pulse amplitude level according to a second specified criteria and a capture pulse amplitude level according to a third specified criteria.

5. The cardiac stimulation device of claim 4 wherein the second specified criteria is A out of the last B stimulation pulses not generating evoked responses, wherein B is greater than 2 and A is less than B.

6. The cardiac stimulation device of claim 4 wherein the third specified criteria is C out of the last D stimulation pulses generating evoked responses, wherein D is greater than 2 and C is less than D.

7. The cardiac stimulation device of claim 4 wherein the stimulation pulse amplitude is set following the threshold search to a predetermined value above the capture pulse amplitude level.

8. The cardiac stimulation device of claim 4 wherein the controller causes the threshold search to be performed following the increase of the stimulation pulse amplitude performed in response to the absence of evoked responses to X out of the last Y stimulation pulses.

9. A method for determining the threshold value for a stimulation pulse for stimulating a patient'"'"'s heart during a cardiac cycle through at least one electrode adapted for electrical contact with selected cardiac tissue, the method comprising:

periodically stimulating the patient'"'"'s heart with a stimulation pulse, the stimulation pulse having a controlled amplitude and rate;

detecting the presence or absence of an evoked response generated by the patient'"'"'s heart in response to the stimulation pulse during a detection window;

increasing the amplitude of the stimulation pulse in response to a first specified evoked response criteria, wherein the first specified criteria is the absence of evoked responses from X out of the last Y stimulation pulses where Y is a value greater than 2 and X is a value less than Y; and

determining for a sequence of cardiac cycles, status responses indicating;

C, the number of pulses having evoked responses, I, the number of detected intrinsic signals that were not in response to a stimulation pulse, B, the number of cardiac cycles that included backup pulses, and Y, the number of cardiac cycles having stimulation pulses, wherein Y equals B+C.

10. A method for determining the threshold value for a stimulation pulse for stimulating a patient'"'"'s heart during a cardiac cycle through at least one electrode adapted for electrical contact with selected cardiac tissue, the method comprising:

periodically stimulating the patient'"'"'s heart with a stimulation pulse, the stimulation pulse having a controlled amplitude and rate;

detecting the presence or absence of an evoked response generated by the patient'"'"'s heart in response to the stimulation pulse during a detection window;

increasing the amplitude of the stimulation pulse in response to a first specified evoked response criteria, wherein the first specified criteria is the absence of evoked responses from X out of the last Y stimulation pulses where Y is a value greater than 2 and X is a value less than Y;

detecting a status response for each cardiac cycle, wherein the status response indicates whether the stimulation pulse had an evoked response, the stimulation pulse did not have an evoked response, or an intrinsic signal was detected without a stimulation pulse;

determining the presence of a predetermined sequence of status responses from M consecutive cardiac cycles;

determining the presence of N contiguous occurrences of the specified sequence of M status responses; and

increasing the controlled stimulation rate in response to the presence of the N contiguous occurrences of the predetermined sequence of M status responses.

11. The method of claim 10 additionally comprising the step of generating a backup pulse following the detection window if no evoked response is detected.

12. The method of claim 11 wherein the backup pulse is set to a predetermined maximum amplitude.

13. The method of claim 10 further comprising the step of periodically adjusting the stimulation pulse amplitude by performing a threshold search to determine a stimulation pulse amplitude capable of causing an evoked response, the threshold search including detecting a non-capture pulse amplitude level according to a second specified criteria and a capture pulse amplitude level according to a third specified criteria.

14. The method of claim 13 wherein the second specified criteria is A out of the last B stimulation pulses not generating evoked responses, wherein B is greater than 2 and A is less than B.

15. The method of claim 13 wherein the third specified criteria is C out of the last D stimulation pulses generating evoked responses, wherein D is greater than 2 and C is less than D.

16. The method of claim 13 wherein the step of periodically performing a threshold search occurs is performed following the step of increasing the amplitude of the stimulation pulse in response to the first specified criteria.

17. An implantable cardiac stimulation device for stimulating a patient'"'"'s heart during a cardiac cycle through at least one electrode implanted in electrical contact with selected cardiac tissue, the stimulation device comprising:

a pulse generator electrically coupled to the electrode and configured to generate stimulation pulses at a controlled amplitude and rate to thereby stimulate the patient'"'"'s heart;

a detection circuit electrically coupled to the electrode and configured to receive cardiac signals for determining the presence or absence of an evoked response in response to each of the stimulation pulses;

storing means for storing a status response for a sequence of cardiac cycles, the status response comprising whether an evoked response (C) was detected, whether a backup pulse (B) was generated, or whether an intrinsic signal (I) was detected without a stimulation pulse;

evaluation means for determining whether a criteria is satisfied based upon the stored status responses;

a controller for causing the pulse generator to increase the amplitude of the stimulation pulses in response to a first specified criteria, wherein the first specified criteria is the absence of evoked responses from X out of the last Y stimulation pulses where Y is a value greater than 2 and X is a value less than Y.

18. The cardiac stimulation device of claim 17 wherein the storing means is a First-In First-Out (FIFO) buffer formed from a shift register.

19. The cardiac stimulation device of claim 17 wherein the storing means is a First-In First-Out (FIFO) buffer formed from a sequence of software instructions executed by the controller.

20. The cardiac stimulation device of claim 17 wherein:

the detection circuit detects the presence of evoked responses during a detection window following each stimulation pulse; and

wherein

the controller causes the pulse generator to generate a backup pulse at the end of each detection window when an evoked response is not detected.

21. The cardiac stimulation device of claim 20 wherein the backup pulse is set to a predetermined maximum amplitude.

22. The cardiac stimulation device of claim 17 wherein the storing means further comprises means to detect a predetermined sequence of status responses from M consecutive cardiac cycles and means for determining the presence of N contiguous occurrences of the predetermined sequence of M status responses, wherein the controller is configured to increase the controlled stimulation rate in response thereto.

23. The cardiac stimulation device of claim 17 wherein the controller is configured to periodically adjust the stimulation pulse amplitude by performing a threshold search to determine a stimulation pulse amplitude capable of causing an evoked response, the threshold search including detecting a non-capture pulse amplitude level according to a second specified criteria and a capture pulse amplitude level according to a third specified criteria.

24. The cardiac stimulation device of claim 23 wherein the second specified criteria is A out of the last B stimulation pulses not generating evoked responses, wherein B is greater than 2 and A is less than B.

25. The cardiac stimulation device of claim 23 wherein the third specified criteria is C out of the last D stimulation pulses generating evoked responses, wherein D is greater than 2 and C is less than D.

26. The cardiac stimulation device of claim 23 wherein the controlled amplitude is set following the threshold search to a predetermined value above the capture pulse amplitude level.

27. The cardiac stimulation device of claim 23 wherein the controller causes the threshold search to be performed following the increase of the stimulation pulse amplitude performed in response to the absence of evoked responses to X out of the last Y stimulation pulses.

28. An implantable cardiac stimulation device for stimulating a patient'"'"'s heart during a cardiac cycle through at least one electrode implanted in electrical contact with selected cardiac tissue, the stimulation device comprising:

a pulse generator electrically coupled to the electrode and configured to generate stimulation pulses at a controlled amplitude and rate to thereby stimulate the patient'"'"'s heart;

a detection circuit electrically coupled to the electrode and configured to receive cardiac signals for determining the presence or absence of an evoked response in response to each of the stimulation pulses;

storing means for storing a status response for a sequence of cardiac cycles, the status response comprising whether an evoked response (C) was detected, whether a backup pulse (B) was generated, or whether an intrinsic signal (I) was detected without a stimulation pulse;

evaluation means for determining whether a predetermined criteria is satisfied based upon the stored status responses, wherein the criteria is the detection of a predetermined sequence of status responses from M consecutive cardiac cycles and the detection of N contiguous occurrences of the predetermined sequence of M status responses; and

a controller for causing the pulse generator to increase the amplitude of the stimulation pulses in response to the predetermined criteria.

29. An implantable cardiac stimulation device for stimulating a patient'"'"'s heart during a cardiac cycle through at least one electrode implanted in electrical contact with selected cardiac tissue, the stimulation device comprising:

a pulse generator electrically coupled to the electrode and configured to generate stimulation pulses at a controlled amplitude and rate to thereby stimulate the patient'"'"'s heart;

a detection circuit electrically coupled to the electrode and configured to receive cardiac signals for determining the presence or absence of an evoked response to each of the stimulation pulses; and

a controller coupled to the pulse generator for increasing the stimulation pulse amplitude when a first specified criteria has been met, wherein the first specified criteria is the absence of evoked responses from X out of the last Y stimulation pulses where Y is a value greater than 2 and X is a value equal to Y.

30. An implantable stimulation device for stimulating a patient'"'"'s body tissue through at least one electrode implanted in electrical contact with selected body tissue, the stimulation device comprising:

a pulse generator electrically coupled to the electrode and configured to generate stimulation pulses at a controlled amplitude and rate to thereby stimulate the patient'"'"'s body tissue;

a detection circuit electrically coupled to the electrode and configured to receive signals for determining the presence or absence of an evoked response to each of the stimulation pulses, wherein the detection circuit is further configured to determine the status, for each cardiac cycle, of the presence of an evoked response to each stimulation pulse, the absence of an evoked response to each stimulation pulse, or the presence of an intrinsic cardiac signal without a stimulation pulse; and

a controller coupled to the pulse generator for increasing the stimulation pulse amplitude when a first specified criteria has been met, wherein the first specified criteria is a repetitive pattern of the absence of evoked responses from X out of the last Y stimulation pulses where Y is a value greater than 2 and X is a value less than Y, wherein the controller determines the presence of a predetermined sequence of status determinations from M consecutive cardiac cycles, and further determines the presence of N contiguous occurrences of the specified sequence of M status determinations, wherein the controller is configured to increase the controlled rate in response thereto.

31. A method for determining the threshold value for a stimulation pulse for stimulating a patient'"'"'s body tissue through at least one electrode implanted in electrical contact with selected body tissue, the method comprising the steps of:

periodically stimulating the patient'"'"'s body tissue with a stimulation pulse, the stimulation pulse having a controlled amplitude and rate;

detecting the presence or absence of an evoked response generated by the patient'"'"'s body tissue in response to the stimulation pulse during a detection window;

increasing the amplitude of the stimulation pulse in response to a first specified evoked response criteria, wherein the first specified criteria is the absence of evoked responses from X out of the last Y stimulation pulses where Y is a value greater than 2 and X is a value less than Y;

detecting a status response for each cardiac cycle, wherein the status response indicates whether the stimulation pulse had an evoked response, the stimulation pulse did not have an invoked response, or an intrinsic signal was detected without a stimulation pulse;

determining the presence of a predetermined sequence of status responses from M consecutive cardiac cycles;

determining the presence of N contiguous occurrences of the specified sequence of M status responses; and

increasing the controlled stimulation rate in response to the presence of the N contiguous occurrences of the predetermined sequence of M status responses.

32. An implantable stimulation device for stimulating a patient'"'"'s body tissue through at least one electrode implanted in electrical contact with selected body tissue, the stimulation device comprising:

a pulse generator electrically coupled to the electrode and configured to generate stimulation pulses at a controlled amplitude and rate to thereby stimulate the patient'"'"'s body tissue;

a detection circuit electrically coupled to the electrode and configured to receive signals for determining the presence or absence of an evoked response in response to each of the stimulation pulses;

storing means for storing a status response for a sequence of stimulation cycles, the status response comprising whether an evoked response (C) was detected, whether a backup pulse (B) was generated, or whether an intrinsic signal (I) was detected without a stimulation pulse;

evaluation means for determining whether a criteria is satisfied based upon the stored status responses;

a controller for causing the pulse generator to increase the amplitude of the stimulation pulses in response to a first specified criteria, wherein the first specified criteria is the absence of evoked responses from X out of the last Y stimulation pulses where Y is a value greater than 2 and X is a value less than Y.

33. An implantable stimulation device for stimulating a patient'"'"'s body tissue through at least one electrode implanted in electrical contact with selected body tissue, the stimulation device comprising:

a pulse generator electrically coupled to the electrode and configured to generate stimulation pulses at a controlled amplitude and rate to thereby stimulate the patient'"'"'s body tissue;

a detection circuit electrically coupled to the electrode and configured to receive signals for determining the presence or absence of an evoked response in response to each of the stimulation pulses;

storing means for storing a status response for a sequence of stimulation cycles, the status response comprising whether an evoked response (C) was detected, whether a backup pulse (B) was generated, or whether an intrinsic signal (I) was detected without a stimulation pulse;

evaluation means for determining whether a predetermined criteria is satisfied based upon the stored status responses, wherein the criteria is the detection of a predetermined sequence of status responses from M consecutive stimulation cycles and the detection of N contiguous occurrences of the predetermined sequence of M status responses; and

a controller for causing the pulse generator to increase the amplitude of the stimulation pulses in response to the predetermined criteria.

34. An implantable cardiac stimulation device for stimulating a patient'"'"'s heart during a cardiac cycle through at least one electrode adapted for electrical contact with selected cardiac tissue, the stimulation device comprising:

a pulse generator, electrically coupled to the electrode, configured to generate stimulation pulses at a controlled amplitude and rate to thereby stimulate the patient'"'"'s heart;

a detection circuit, electrically coupled to the electrode and configured to receive cardiac signals, that detects capture events or loss-of-capture events in response to each'"'"'of the stimulation pulses; and

a controller, coupled to the pulse generator, for adjusting one of the stimulation pulse amplitude or the rate when a first specified criteria has been met, the first specified criteria being a repetitive pattern of “

X”

captured events followed by “

Y”

loss-of-capture events.

35. The implantable cardiac stimulation of claim 34, wherein:

the repetitive pattern is a bigeminy-type repetitive pattern having one captured event followed by one loss-of-capture event out of two consecutive cardiac cycles.

36. The implantable cardiac stimulation of claim 34, wherein:

the repetitive pattern is a trigeminy-type repetitive pattern having at least one captured event followed by at least one loss-of-capture event out of three consecutive cardiac cycles.

37. The implantable cardiac stimulation of claim 34, wherein:

the repetitive pattern is a pattern having “

N”

contiguous occurrences of at least one captured event followed by at least one loss-of-capture event out of each “

M”

consecutive cardiac cycles.

38. The implantable cardiac stimulation of claim 34, wherein:

the controller selectively ignores intrinsic events as part of the repetitive pattern.

39. The implantable cardiac stimulation of claim 34, wherein:

the controller selectively ignores premature ectopic events as part of the repetitive pattern.

40. A method for determining the threshold value for a stimulation pulse for stimulating a patient'"'"'s body tissue through at least one electrode implanted in electrical contact with selected body tissue, the method comprising the steps of:

periodically stimulating the patient'"'"'s body tissue with a stimulation pulse, the stimulation pulse having a controlled amplitude and rate;

detecting captured events and loss-of-capture events in response to the stimulation pulse during a detection window;

increasing the amplitude of the stimulation pulses when a repetitive pattern of “

X”

captured events followed by “

Y”

loss-of-capture events occurs.

41. A method for determining the threshold value for a stimulation pulse for stimulating a patient'"'"'s body tissue through at least one electrode implanted in electrical contact with selected body tissue, the method comprising the steps of:

periodically stimulating the patient'"'"'s body tissue with a stimulation pulse, the stimulation pulse having a controlled amplitude and rate;

detecting captured events and loss-of-capture events in response to the stimulation pulse during a detection window;

increasing the rate of the stimulation pulses when a repetitive pattern of “

X”

captured events followed by “

Y”

loss-of-capture events occurs.