Atrial and ventricular capture detection and threshold-seeking pacemaker

• US 5,601,615 A
• Filed: 08/16/1994
• Issued: 02/11/1997
• Est. Priority Date: 08/16/1994
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Zhou, Ren, Markowitz, H. T., Rueter, John C., Stroebel, John C.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US08/291,304
• Time in Patent Office: 910 Days
• Field of Search: 607/11, 607/25, 607/27, 607/28
• US Class Current: 607/28
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold
• CPC Class Codes: A61N 1/3714 Atrial capture

Abstract

Capture detection and stimulation threshold-measurement methods and apparatus for deriving atrial and ventricular pace pulse (A-pace and V-pace) stimulation energy strength-duration data. In a first atrial and ventricular threshold test regimen for use with patients having intact A-V conduction or first degree AV block, A-pace pulses are delivered at a test escape interval and A-V delay. Atrial loss of capture (ALOC) in response to an A-pace test stimulus is declared by the absence of a detected ventricular depolarization (V-event) in the latter portion of the paced A-V delay interval following the delivery of the A-pace test stimulus. In the ventricular threshold test regimen, a V-pace test stimulus is delivered after a shortened A-V delay. Ventricular loss of capture (VLOC) is declared by the detection of a V-event in the ventricular refractory period of the V-pace test stimulus. In a second algorithm for use in the atrium or ventricle in patients having regular measured sinus rhythm, premature A-pace or V-pace test stimuli are delivered, and the presence of an A-event or V-event at the end of the measured sinus escape interval is declared to be ALOC or VLOC, respectively. A-pace and V-pace test stimuli are repeated to confirm capture declarations at an energy exceeding the LOC test energy. The atrial and ventricular stimulation threshold data derived by varying both pulse amplitude (strength) and width (duration) is stored in memory for telemetry out and analysis and for use in setting the V-pace and A-pace normal pulse width and amplitude used between successive auto-capture tests in order to conserve battery energy.

Claims

1. A dual chamber pacemaker pulse generator for attachment with atrial and ventricular pacing and sensing electrodes said electrodes being for delivering electrical pulses from said generator for pacing and sensing depolarizations of a patient'"'"'s heart in the atrium and the ventricle respectively, said pacing being at adjustable atrial and ventricular pacing pulse energies wherein said generator comprises:

variable escape interval timing means for establishing an atrial normal rate escape interval;

atrial pace pulse generator means for generating an atrial pace pulse through said atrial pacing electrodes at the end of said atrial normal rate escape interval in the absence of an atrial sensed event signal at a normal pace pulse energy;

atrial sensing means adapted to be coupled through said atrial sense electrodes for generating an atrial sensed event signal in response to a natural depolarization of atrial tissue during at least a major portion of said atrial normal rate escape interval;

atrial-ventricular delay timing means for establishing an A-V delay interval commencing in timed relation to an atrial sensed event signal or an atrial pace pulse and where in relation to a pace pulse said A-V delay interval comprises a first and second temporal portion;

ventricular sensing means adapted to be coupled to said ventricular electrodes for generating a ventricular sensed event signal in response to a depolarization of ventricular tissue;

ventricular pace pulse generator means for generating a ventricular pace pulse at said ventricular electrodes at the end of said A-V delay interval in the absence of a ventricular sensed event signal detected within said A-V delay interval;

atrial stimulation threshold test means for operating said escape interval timing means at atrial pace test escape intervals and for initiating the delivery of an atrial pace test stimulus by said atrial pace pulse generator means at the end of an atrial pace test escape interval operated by said atrial test means at an atrial pace test pulse energy varying from said normal atrial pace pulse energy in an atrial pace test cycle;

atrial capture detection means responsive to said ventricular sensing means for declaring atrial capture following the delivery of an atrial pace test stimulus by the detection of a ventricular sensed event signal in said second temporal portion of the A-V delay interval following the delivery of the atrial pace test stimulus; and

atrial loss of capture detection means responsive to said ventricular sensing means for declaring atrial loss of capture following the delivery of an atrial pace test stimulus by the absence of a ventricular sensed event signal detected in the A-V delay interval.

2. The pacemaker pulse generator of claim 1 wherein said atrial stimulation threshold test means further comprises:

means for setting the atrial test escape interval to correspond to an atrial pace test rate exceeding the natural atrial depolarization rate of the patient'"'"'s atrium; and

means for determining a starting atrial pace test pulse energy that consistently results in capture of the patient'"'"'s atrium at said atrial test rate.

3. The pacemaker pulse generator of claim 2 wherein said atrial capture detection means further comprises:

means for defining a time window interval commencing with said A-V delay interval and timing out at a time within said A-V delay interval before a conducted ventricular depolarization resulting from the capture of the atrium would have been expected to appear at the site of the ventricular electrodes said time window thereby defining a portion of said A-V delay interval; and

means for declaring a ventricular sensed event occurring during said time window interval as a natural ventricular depolarization not resulting from capture of the patient'"'"'s atrium by the preceding atrial pace test stimlus and not indicative of atrial capture or loss of capture by the preceding atrial pace test stimulus.

4. The pacemaker pulse generator of claim 3 wherein said atrial stimulation threshold test means further comprises:

means for reducing the atrial pace test pulse energy of the succeeding atrial pace test stimuli and repeating the delivery of atrial pace test stimuli by said atrial pace pulse generator means at the end of successive test escape intervals at successively reduced atrial test pace pulse energies until atrial loss of capture is declared at a reduced atrial test pulse energy; and

means responsive to declaration of atrial loss of capture for repeating the delivery of atrial pace test stimuli by said atrial pace pulse generator means at the end of successive atrial test escape intervals at the atrial pace test pulse energy of a preceding declared atrial capture until such atrial capture is declared at least twice.

5. The pacemaker pulse generator of claim 4 wherein said pulse energy reducing means further comprises means for reducing the atrial pace test stimulus pulse width until atrial loss of capture is declared at a reduced pulse width indicative of the atrial stimulation pulse width threshold and for thereafter reducing the atrial pace test stimulus pulse amplitude until atrial loss of capture is declared at a reduced pulse amplitude indicative of the atrial stimulation pulse amplitude threshold.

6. The pacemaker pulse generator of claim 5 further comprising:

means for storing a value representative of the atrial test stimulus pulse width and pulse amplitude at atrial loss of capture or at atrial capture; and

means operable on command of a remote programmer located outside the patient'"'"'s body for telemetering said stored atrial pulse width and amplitude values to said remote programmer.

7. The pacemaker pulse generator of claim 6 further comprising:

means for setting the normal atrial pace pulse energy at a normal pace pulse width and pulse amplitude exceeding the atrial loss of capture stimulation threshold pulse width and pulse amplitude by a safety margin.

8. The pacemaker pulse generator of claim 7 wherein said atrial pace pulse generator means further comprises:

means responsive to the atrial loss of capture declared by said atrial loss of capture detection means for generating an atrial backup pace pulse for pacing the atrium at the end of the following atrial pace normal rate escape interval.

9. The pacemaker pulse generator of claim 1 wherein said atrial pace pulse generator means further comprises:

means responsive to the atrial loss of capture declared by said atrial loss of capture detection means for generating an atrial backup pace pulse for pacing the atrium at the end of the following atrial pace normal rate escape interval.

10. The pacemaker pulse generator of claim 1 further comprising:

means for storing a value representing the energy of an atrial test pulse that caused said atrial loss of capture detection means to determine loss of capture due to absence of a sensed ventricular event as atrial stimulation threshold data.

11. The pacemaker pulse generator of claim 10 further comprising:

means for setting the normal atrial pace pulse energy at a normal pace pulse energy exceeding an energy value represented by the atrial stimulation threshold data by a safety margin.

12. The pacemaker pulse generator of claim 1 wherein said atrial capture detection means further comprises:

means for defining a time window interval commencing with said A-V delay interval and timing out at a time within said A-V delay interval before the conducted ventricular depolarization resulting from the capture of the atrium would be expected to appear at the site of the ventricular electrodes; and

means for declaring a ventricular sensed event occurring during said time window interval as a natural ventricular depolarization not resulting from capture of the patient'"'"'s atrium by the preceding atrial pace test stimulus and not indicative of atrial capture or loss of capture by the preceding atrial test stimulus.

13. The pacemaker pulse generator of claim 12 wherein said atrial stimulation threshold test means further comprises:

means for reducing the atrial test pulse energy of the succeeding atrial pace test stimuli and repeating the delivery of atrial pace test stimuli by said atrial pace pulse generator means at the end of successive test escape intervals at successively reduced atrial test pace pulse energies until atrial loss of capture is declared at a reduced atrial test pulse energy; and

means responsive to declaration of atrial loss of capture for repeating the delivery of atrial pace test stimuli by said atrial pace pulse generator means at the end of successive atrial test escape intervals at the atrial pace test pulse energy of a preceding declared atrial capture until such atrial capture is declared at least twice.

14. A dual chamber pacemaker pulse generator for attachment with atrial and ventricular pacing and sensing electrodes said electrodes being for delivering electrical pulses from said generator for pacing and sensing depolarizations of a patient'"'"'s heart in the atrium and the ventricle, respectively, aid pacing being at adjustable atrial and ventricular pacing pulse energies and wherein said generator comprises:

variable escape interval timing means for establishing an atrial normal rate escape interval and an atrial test escape interval;

atrial pace pulse generator means for generating an atrial pace pulse through said atrial pacing electrodes at the end of said atrial normal rate escape interval in the absence of an atrial sensed event signal at a normal pace pulse energy;

atrial sensing means adapted to be coupled through said atrial sense electrodes for generating an atrial sensed event signal in response to a natural depolarization of atrial tissue during at least a major portion of said atrial normal rate escape interval;

atrial-ventricular delay timing means for establishing an A-V delay interval commencing in timed relation to an atrial sensed event signal or an atrial pace pulse;

ventricular sensing means adapted to be coupled through said ventricular sense electrodes for generating a ventricular sensed event signal ventricular pace pulse generator means for generating a ventricular pace pulse through said ventricular pacing electrodes at the end of said A-V delay interval in the absence of a ventricular sensed event signal detected within said A-V delay interval;

means for establishing a ventricular refractory period time interval following delivery of a ventricular pace pulse;

ventricular stimulation threshold test means periodically operable for initiating a ventricular stimulation threshold test further comprising;

means for operating said escape interval timing means at atrial pace test escape intervals and said atrial-ventricular delay timing means at a test A-V delay interval commencing in timed relation to the delivery of an atrial pace pulse;

means for operating said atrial pace pulse generator means to generate an atrial pace pulse at the end of the atrial pace test escape interval at an atrial pace pulse energy sufficient to ensure that atrial capture is achieved and that a conducted ventricular depolarization follows outside said test A-V delay interval; and

means for initiating the delivery of a ventricular pace test stimulus by said ventricular pace pulse generator means at the end of said test A-V delay interval which is timed to render the patient'"'"'s ventricle refractory to potential subsequent intrinsically conducted depolarization stimulus captures and depolarizes the ventricle; and

ventricular capture detection means responsive to said ventricular sensing means for declaring ventricular capture by the absence of a ventricular sensed event signal in the ventricular refractory period following delivery of the ventricular pace test stimulus.

15. The pacemaker pulse generator of claim 14 wherein said ventricular stimulation threshold test means further comprises:

means for setting the atrial test escape interval to correspond to an atrial test rate exceeding the natural atrial depolarization rate of the patient'"'"'s atrium; and

means for determining a starting atrial pace and ventricular pace test pulse energy that consistently results in capture of the patient'"'"'s atrium and ventricle, respectively, at said atrial test rate.

16. The pacemaker pulse generator of claim 14 further comprising:

ventricular loss of capture detection means responsive to said ventricular sensing means for declaring ventricular loss of capture following the delivery of a ventricular pace test stimulus by the presence of a ventricular sensed event signal detected within the ventricular refractory period.

17. The pacemaker pulse generator of claim 16 wherein said ventricular loss of capture detection means further comprises:

means operable in response to a declaration of ventricular loss of capture for repeating the delivery of ventricular pace test stimuli by said ventricular pace pulse generator means during a next test pacing cycle at the ventricular test pace pulse energy previously declared as ventricular capture to confirm the threshold capture energy over at least two test pacing cycles.

18. The pacemaker pulse generator of claim 17 further comprising a test pacing cycle repeating means

for reducing the ventricular pace test stimulus pulse width through a series of test pacing cycles until ventricular loss of capture is declared at a reduced pulse width indicative of the ventricular stimulation pulse width threshold and for thereafter reducing the ventricular pace test stimulus pulse amplitude through a series of test pacing cycles until ventricular loss of capture is declared at a reduced pulse amplitude indicative of the ventricular stimulation pulse amplitude threshold.

19. The pacemaker pulse generator of claim 18 further comprising:

means for storing values representing the ventricular test pulse width and pulse amplitude at ventricular loss of capture and/or ventricular capture as ventricular threshold test data; and

means operable on command of a remote programmer located outside the patient'"'"'s body for telemetering said stored ventricular threshold test data to said remote programmer.

20. The pacemaker pulse generator of claim 19 further comprising:

means for setting a normal ventricular pace pulse energy value at a normal pace pulse width and pulse amplitude exceeding at least one of the ventricular loss of capture stimulation threshold pulse width and pulse amplitude values by a safety margin.

21. The pacemaker pulse generator of claim 20 wherein said ventricular loss of capture detection means further comprises:

means responsive to the ventricular loss of capture declared by said ventricular loss of capture detection means for providing a backup pacing pulse to capture the ventricle at the end of the following normal escape interval.

22. The pacemaker pulse generator of claim 16 wherein said ventricular loss of capture detection means further comprises:

means responsive to the ventricular loss of capture declared by said ventricular loss of capture detection means for providing a backup pacing pulse to capture the ventricle at the end of the following normal escape interval.

23. The pacemaker pulse generator of claim 16 further comprising:

means for storing the ventricular test pulse width and pulse amplitude values at ventricular loss of capture and/or ventricular capture as ventricular threshold test data; and

means operable on command of a remote programmer located outside the patient'"'"'s body for telemetering said stored ventricular threshold test data to said remote programmer.

24. The pacemaker pulse generator of claim 16 further comprising:

means for setting a normal ventricular pace pulse energy at a normal pace pulse energy exceeding the ventricular loss of capture stimulation threshold pulse energy by a safety margin.

25. The pacemaker pulse generator of claim 14 further comprising a test pacing cycle repeating means

for reducing the ventricular pace test stimulus pulse energy through a series of test pacing cycles until ventricular loss of capture is declared at a reduced pulse energy level indicative of the ventricular stimulation pulse energy threshold.

26. A dual chamber pacemaker implantable pulse generator for attachment with atrial and ventricular pacing and sensing electrodes said electrodes being for delivering electrical pulses from said generator for pacing and sensing depolarization of a patient'"'"'s heart in the atrium and the ventricle respectively, said being at adjustable atrial and ventricular pacing pulse energies, said generator comprising:

variable escape interval timing means for establishing a normal atrial rate escape interval;

atrial pace pulse generator means for generating an atrial pace pulse through said atrial pacing electrodes at the end of said normal atrial rate escape interval in the absence of an atrial sensed event signal at a normal pace pulse energy;

atrial sensing means adapted to be coupled through said atrial sense electrodes for generating an atrial sensed event signal in response to a natural depolarization of atrial tissue during at least a major portion of said normal atrial rate escape interval;

atrial-ventricular delay timing means for establishing an A-V delay interval commencing in timed relation to an atrial sensed event signal or an atrial pace pulse and where in relation to a pace pulse said A-V delay interval comprises a first and second temporal portion;

ventricular sensing means adapted to be coupled to said ventricular electrodes for generating a ventricular sensed event signal in response to a depolarization of ventricular tissue;

ventricular pace pulse generator means for generating a ventricular pace pulse at said ventricular electrodes at the end of said A-V delay interval in the absence of a ventricular sensed event signal detected within said A-V delay interval;

means for establishing a ventricular refractory period time interval following delivery of a ventricular pace pulse;

pace test stimulus by the presence of a ventricular sensed event signal detected within the ventricular refractory period; and

ventricular capture detection means responsive to said ventricular sensing means for declaring ventricular capture by the absence of a ventricular sensed event signal in the ventricular refractory period following delivery of the ventricular pace test stimulus; and

means for periodically triggering the operation of said atrial and ventricular stimulation threshold test means in a predetermined sequence of successive test pacing cycles to derive atrial and ventricular stimulation threshold test data related to the declarations of atrial and ventricular capture and loss of capture.

27. The pacemaker pulse generator of claim 26 further comprising:

means for storing said atrial and ventricular stimulation threshold test data;

means for retriving and transmitting said stored atrial and ventricular stimulation threshold test data on command to a remote receiver for review and analysis.

28. The pacemaker pulse generator of claim 26 further comprising:

means for storing said atrial and ventricular stimulation threshold test data; and

means for adjusting the atrial and ventricular pace pulse energies of the atrial and ventricular pace pulses generated by said atrial and ventricular pace pulse generator means to energy values in excess of said stored atrial and ventricular stimulation threshold test data.

29. The pacemaker pulse generator of claim 26 wherein said atrial capture detection means further comprises:

means for defining a time window interval commencing with said A-V delay interval and timing out at a time within said A-V delay interval before the conducted ventricular depolarization resulting from the capture of the atrium would be expected to appear at the site of the ventricular electrodes; and

means for declaring a ventricular sensed event occurring during said time window interval as a natural ventricular depolarization not resulting from capture of the patient'"'"'s atrium by the preceding atrial pace test stimulus and not indicative of atrial capture or loss of capture by the preceding atrial pace test stimulus.

30. The pacemaker pulse generator of claim 26 wherein said ventricular loss of capture detection means further comprises:

means responsive to the ventricular loss of capture declared by said ventricular loss of capture detection means for providing a backup pacing cycle employing backup atrial and ventricular pace pulse energies at the end of the following normal escape interval.

31. The pacemaker pulse generator of claim 26 wherein said test pacing cycle repeating means further comprises:

means for reducing the ventricular pace test stimulus pulse width through a series of test pacing cycles until ventricular loss of capture is declared at a reduced pulse width indicative of the ventricular stimulation pulse width threshold and for thereafter reducing the ventricular pace test stimulus pulse amplitude through a series of test pacing cycles until ventricular loss of capture is declared at a reduced pulse amplitude indicative of the ventricular stimulation pulse amplitude threshold.

32. The pacemaker pulse generator of claim 26 wherein said test pacing cycle repeating means further comprises:

means for reducing the atrial test pulse energy of the succeeding atrial pace test pulse and repeating delivery of atrial pace test pulse by said atrial pace pulse generator means at the end of successive test escape intervals at successively reduced atrial test pace pulse energies until atrial loss of capture is declared at a reduced atrial test pulse energy; and

means responsive to declaration of atrial loss of capture for repeating the delivery of atrial pace test stimuli by said atrial pace pulse generator means at the end of successive atrial test escape intervals at the atrial pace test pulse energy of a preceding declared atrial capture until such atrial capture is declared at least twice.

33. The pacemaker pulse generator of claim 32 wherein said test pacing cycle repeating means further comprises:

means for reducing a ventricular pace test pulse width through a series of test pacing cycles until ventricular loss of capture is declared at a reduced pulse width indicative of the ventricular stimulation pulse width threshold and for thereafter reducing the ventricular pace test stimulus pulse amplitude through a series of test pacing cycles until ventricular loss of capture is declared at a reduced pulse amplitude indicative of the ventricular stimulation pulse amplitude threshold.

34. In a pacemaker pulse generator having atrial and ventricular pulse generators for generating and applying atrial and ventricular pacing pulses to the atrium and ventricle of the heart separated by an A-V delay interval to evoke stimulated atrial and ventricular depolarizations and capture the atrium and ventricle and a ventricular sense amplifier for sensing natural depolarizations of the ventricle, a method of testing for the stimulation threshold energy of the ventricle comprising the steps of:

determining the patient'"'"'s atrial escape interval;

operating said atrial pulse generator to deliver an atrial pace pulse at an energy sufficient to capture the atrium when said atrial escape interval times out;

setting a test pace A-V delay interval;

operating said ventricular pulse generator to deliver a ventricular test stimulus at the end of said test pace A-V delay interval;

setting a ventricular sense time window;

operating said ventricular sense amplifier during said ventricular sense time window to sense a depolarization of the ventricle;

declaring capture of the ventricle by the ventricular test stimulus if a depolarization of the ventricle is not sensed in the ventricular sense time window; and

declaring loss of capture of the ventricle by the ventricular test stimulus if a depolarization of the ventricle is sensed in the ventricular sense time window.

35. In a pacemaker pulse generator having an atrial pulse generator for generating and applying atrial pacing pulses to the atrium of the heart to evoke a stimulated depolarization and capture the atrium and a ventricular sense amplifier for sensing natural depolarizations of the ventricle, apparatus for testing for the stimulation threshold energy of the atrium comprising:

means for determining the patient'"'"'s atrial escape interval;

means for operating said atrial pulse generator to deliver an atrial test pulse at a test energy to the atrium in the atrial escape interval timed to capture the atrium if the test energy is sufficient to capture the atrium after said atrial escape interval times out;

means for setting a paced A-V delay interval beginning after a PVC blanking period following said atrial test pulse;

means for operating the ventricular sense amplifier during at least the paced A-V delay interval to sense a depolarization of the ventricle;

means for declaring capture of the atrium by the atrial test pacing pulse if a depolarization of the ventricle is sensed in the paced A-V delay interval; and

means for declaring loss of capture of the atrium by the atrial test pacing pulse if a depolarization of the ventricle is not sensed in the paced A-V delay interval.

36. In a pacemaker pulse generator having atrial and ventricular pulse generators for generating and applying atrial and ventricular pacing pulses to the atrium and ventricle of the heart separated by an A-V delay interval to evoke stimulated atrial and ventricular depolarizations and capture the atrium and ventricle and a ventricular sense amplifier for sensing natural depolarizations of the ventricle, apparatus for testing for the stimulation threshold energy of the ventricle comprising:

means for determining the patient'"'"'s atrial escape interval;

means for operating said atrial pulse generator to deliver an atrial pace pulse at an energy sufficient to capture the atrium after said atrial escape interval times out;

means for setting a test pace A-V delay interval;

means for operating said ventricular pulse generator to deliver a ventricular test stimulus at the end of said test pace A-V delay interval;

means for setting a ventricular sense time window;

means for operating said ventricular sense amplifier during said ventricular sense time window to sense a depolarization of the ventricle;

means for declaring capture of the ventricle by the ventricular test stimulus if a depolarization of the ventricle is not sensed in the ventricular sense time window; and

means for declaring loss of capture of the ventricle by the ventricular test stimulus if a depolarization of the ventricle is sensed in the ventricular sense time window.

37. An apparatus comprising a dual chamber pacemaker pulse generator for attachment with atrial and ventricular sensing and pacing electrodes to an atrial and ventricular chamber of a patient'"'"'s heart, respectively and having means for detecting capture during that refractory period which follows the delivery of a pacing pulse in one of said chambers by sensing depolarizations of tissue in the other of said chambers and having timing means for excluding sensed depolarizations too close in time to the delivery of a pacing pulse in said one chamber.