Upper rate response for implantable pacemaker based on atrial lock interval pacing

• US 5,540,725 A
• Filed: 07/11/1995
• Issued: 07/30/1996
• Est. Priority Date: 07/11/1995
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Bornzin, Gene A., Mann, Brian M.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US08/500,731
• Time in Patent Office: 385 Days
• Field of Search: 607/9, 607/14, 607/24
• US Class Current: 607/9
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence

Abstract

Atrial lock interval pacing increases stroke volume and optimizes cardiac output by providing a modified P-wave tracking mode that tracks P-waves up to a maximum instantaneous tracking rate only for short periods of time, to provide a maximum instantaneous ventricular heart rate, yet limits the maximal mean (or average) ventricular rate over a longer period of time, to provide a safe target maximal average rate. Two main types or embodiments of modified P-wave tracking modes may be used. A first provides a sequence of timed intervals that begins upon sensing each P-wave. Such sequence may include, e.g.: (1) a PV interval; (2) a PVARP; (3) a Wenkebach interval; (4) an atrial lock interval; and (4) a P-track interval. P-waves are not tracked during the PV interval or PVARP. P-waves that occur during the Wenkebach or Atrial lock interval are tracked, but not in a conventional manner. P-waves that occur during the P-track interval are tracked in a conventional manner. A second modified P-wave tracking mode defines a maximum mean rate (MMR) interval. The MMR interval (MMRI) is an asynchronous free-running signal that is not synchronized to any cardiac cycle events. During each MMRI, the number of atrial or ventricular events that occur are noted. Ventricular stimulation pulses (V-pulses) are not generated if the resulting ventricular depolarization would represent the second ventricular depolarization of the current MMRI.

Claims

1. A method of operating a dual-chamber pacemaker in a P-tracking mode that maintains synchrony between atrial and ventricular events for a higher percentage of the time when operating at upper rate limits, the pacemaker including means for sensing P-waves and R-waves, and means for generating V-pulses, the method comprising:

tracking P-waves by generating a V-pulse one PV delay after sensing a P-wave, unless an R-wave is sensed prior to the end of the PV delay, in which case no V-pulse is generated, up to a first maximal tracking rate, whereby an instantaneous ventricular rate is limited by the first maximal tracking rate; and

limiting a maximal mean ventricular rate to a second maximal tracking rate, said second maximal tracking rate being less than the first maximal tracking rate.

2. The method of claim 1, wherein the step of limiting the maximal mean ventricular rate to the second maximal tracking rate comprises:

setting a pacing interval for the pacemaker that is the sum of a PV delay, a post ventricular refractory period (PVARP), a Wenkebach interval (WI), an atrial lock interval (ALI) and a P-track interval;

where the PV delay, PVARP, WI, ALI and P-track intervals are each set to a fixed value for any given cardiac cycle, but where the PV delay may be terminated early by sensing an R-wave prior to its termination, and where the P-track interval may also be terminated early by sensing a P-wave prior to its termination;

starting a pacing interval upon sensing a P-wave by beginning the PV delay;

starting the PVARP at the end of the PV delay;

starting the WI at the end of the PVARP;

starting the ALI at the end of the WI;

sensing whether a P-wave occurs during either the WI or ALI, and if so, tracking the sensed P-wave in a first delayed manner; and

if a P-wave is not sensed during either the WI or ALI, then starting the P-track interval at the end of the ALI;

the first maximal tracking rate comprising 1/(PVD+PVARP+WI), and the second maximal tracking rate comprising 1/(PVD+PVARP+WI+ALI), where PVD is the PV delay.

3. The method of claim 2, wherein tracking the sensed P-wave in a first delayed manner comprises:

if a P-wave is sensed during the WI, starting a new pacing interval at the end of the ALI following the WI during which the P-wave was sensed; and

if a P-wave is sensed during the ALI, immediately starting a second PV delay and generating a V-pulse at the conclusion of the second PV delay.

4. The method of claim 3 further including, if a P-wave is sensed during the ALI, and after immediately starting the second PV delay, continuing to time out the ALI during which the P-wave was sensed, and starting a new pacing interval at the end of the ALI, and inhibiting the generation of a V-pulse at the end of the PV delay of the new pacing interval.

5. The method of claim 2, further including setting the WI to be 0 ms, whereby the ALI is started at the end of the PVARP.

6. The method of claim 1, wherein the step of limiting the maximal mean ventricular rate to the second maximal tracking rate comprises:

setting a pacing interval for the pacemaker that is the sum of a PV delay, a post ventricular refractory period (PVARP), an atrial lock interval (ALI), a Wenkebach interval (WI), and a P-track interval;

where the PV delay, PVARP, ALI, WI, and P-track intervals are each set to a fixed value for any given cardiac cycle, but where the PV delay may be terminated early by sensing an R-wave prior to its termination, and where the P-track interval may also be terminated early by sensing a P-wave prior to its termination;

starting a pacing interval upon sensing a P-wave by beginning the PV delay;

starting the PVARP at the end of the PV delay;

starting the ALI at the end of the PVARP;

starting the WI at the end of the ALI;

sensing whether a P-wave occurs during either the ALI or WI, and if so, tracking the sensed P-wave in a first delayed manner; and

if a P-wave is not sensed during either the ALI or WI, then starting the P-track interval at the end of the WI;

the first maximal tracking rate comprising 1/(PVD+PVARP+ALI), and the second maximal tracking rate comprising 1/(PVD+PVARP+ALI+WI), where PVD is the PV delay.

7. The method of claim 6, wherein tracking the sensed P-wave in a first delayed manner comprises:

if a P-wave is sensed during the ALI, immediately starting an extended PV delay and generating a V-pulse at the conclusion of the extended PV delay; and

if a P-wave is sensed during the WI, starting a new pacing interval at the end of the WI during which the P-wave was sensed.

8. The method of claim 7, wherein the step of starting an extended PV delay comprises starting a new PV delay having a value equal to the prior PV delay plus the WI.

9. The method of claim 7, further including, if a P-wave is sensed during the ALI, and after immediately starting the extended PV delay, continuing to time out the ALI during which the P-wave was sensed, starting a new pacing interval at the end of the ALI that begins with a second extended PV delay, and inhibiting the generation of a V-pulse at the end of the second extended PV delay of the new pacing interval.

10. The method of claim 1, further comprising defining the first maximal tracking rate and the second maximal tracking rate to be respective fixed rates.

11. The method of claim 1, further comprising allowing either the first maximal tracking rate or the second maximal tracking rate to be a pseudorandom rate.

12. A method of limiting the maximal mean ventricular rate of a pacemaker, the pacemaker including sensing means for sensing P-waves, pulse generation means for generating V-pulses, and timing means for defining timed intervals, the method comprising:

generating a recurring cycle of maximum mean rate intervals (MMRI) of x seconds each that runs independent of any sensed events;

tracking only a first sensed P-wave in each MMRI by;

(i) starting a PV delay upon the sensing of the first sensed P-wave in the MMRI, and (ii) generating a V-pulse at the conclusion of the PV interval; and

not tracking any subsequent sensed atrial events that occur during the MMRI.

13. A method of limiting the maximal mean ventricular rate of a pacemaker, the pacemaker including sensing means for sensing P-waves and R-waves;

pulse generation means for generating V-pulses; and

timing means for defining timed intervals; and

wherein an R-wave or a V-pulse comprises a ventricular event;

the method comprising;

generating a recurring cycle of maximum mean rate intervals (MMRI) of x seconds each that runs independent of any sensed events; and

allowing only one ventricular event in each MMRI.

14. A method of operating a dual-chamber pacemaker in a P-tracking mode at upper rate limits, the pacemaker including means for sensing P-waves and R-waves, and means for generating V-pulses, the method comprising:

tracking P-waves by generating a V-pulse one PV delay after sensing a P-wave up to a first upper rate limit, whereby an instantaneous ventricular rate is limited by the first upper rate limit; and

limiting a maximal mean ventricular rate to a second upper rate limit that is less than the first upper rate limit, while allowing an instantaneous ventricular rate to exceed the second upper rate limit and approach the first upper rate limit.

15. The method, as set forth in claim 14, wherein the step of limiting the maximal mean ventricular rate to the second upper rate limit comprises:

setting a pacing interval for the pacemaker that is the sum of a PV delay, a post ventricular refractory period (PVARP), an atrial lock interval (ALI), a Wenkebach interval (WI), and a P-track interval;

where the PV delay, PVARP, ALI, WI and P-track intervals are each set to a fixed value for any given cardiac cycle, and where the P-track interval may be terminated early by sensing a P-wave or R-wave prior to its termination;

starting a pacing interval upon sensing a P-wave by beginning the PV delay;

starting the PVARP at the end of the PV delay;

starting the ALI and WI intervals in a prescribed ALI/WI sequence at the end of the PVARP;

sensing whether a P-wave occurs during the ALI/WI sequence, and if so, tracking such P-wave in a delayed manner, and if not so, then starting the P-track interval at the end of the ALI/WI sequence;

the first upper rate limit being defined by 1/(PVD+PVARP), and the second upper rate limit being defined by 1/(PVD+PVARP+ALI), where PVD is the PV delay.

16. The method, as set forth in claim 15, wherein starting the ALI and WI intervals in a prescribed sequence comprises starting the ALI at the end of the PVARP and then starting the WI at the end of the ALI.

17. The method, as set forth in claim 15, wherein starting the ALI and WI intervals in a prescribed sequence comprises starting the WI at the end of the PVARP and then starting the ALI at the end of the WI.

18. The method, as set forth in claim 14, wherein the step of limiting the maximal mean ventricular rate to the second upper rate limit comprises:

generating a free-running sequence of a recurring maximum mean rate interval (MMRI), each MMRI of the free-running sequence having a duration of T seconds, the MMRI sequence running asynchronously relative to any sensed P-waves, R-waves, or generated V-pulses;

tracking only a first sensed P-wave in each MMRI and not tracking any subsequent sensed P-waves that occur during the MMRI.

19. The method, as set forth in claim 18, further including setting T to be equal to 300 to 600 milliseconds.

20. The method, as set forth in claim 14, wherein the step of limiting the maximal mean ventricular rate to the second upper rate limit comprises:

generating a free-running sequence of a recurring maximum mean rate interval (MMRI), each MMRI of the free-running sequence having a duration of T seconds, the MMRI sequence running asynchronously relative to any sensed P-waves, R-waves or generated V-pulses; and

allowing only one ventricular event in each MMRI, where a ventricular event comprises either an R-wave or a V-pulse.

21. The method, as set forth in claim 20, further including setting T to be equal to 300 to 600 ms.

22. In a dual-chamber pacemaker, a system for increasing stroke volume at upper pacemaker rates, the pacemaker including means for sensing P-waves and R-waves, and means for generating V-pulses, the system comprising:

P-wave tracking means for providing a ventricular rate that tracks sensed P-waves;

upper rate limiting means for limiting the P-wave tracking means so that P-waves are instantaneously tracked up to a maximal tracking rate, thereby providing an instantaneous ventricular rate that tracks the sensed P-waves up to the maximal tracking rate; and

average-rate limiting means for limiting an average ventricular rate to a value that is less than the maximal tracking rate.

23. The system of claim 22, wherein the upper rate limiting means comprises

timing means for defining a pacing interval for the pacemaker that is the sum of a PV interval (PVI), a post ventricular refractory period (PVARP), an atrial lock interval (ALI) and a P-track interval;

and where the timing means sets the PV delay, PVARP, ALI and P-track interval to a specified value for any given cardiac cycle, but where at least the P-track interval may vary in value from cardiac cycle to cardiac cycle; and

wherein the P-wave tracking means includes blocking means for blocking any P-wave that occurs during the PV delay or PVARP, and V-pulse response means for generating a V-pulse one PV delay after a P-wave that occurs during the ALI or P-track interval; and

further

wherein the means for limiting the average ventricular rate comprises means for generating a second PV interval at the conclusion of any ALI during which a P-wave occurs without generating a V-pulse at the conclusion thereof, and generating a second PVARP following the second PV delay, which second PV interval and second PVARP begin a next pacing interval;

whereby P-waves may be instantaneously tracked up to a maximal tracking rate that comprises 1/(PVI+PVARP), yet the average ventricular rate is limited to a value that approaches 1/(PVI+PVARP+ALI).

24. The system of claim 23, wherein the timing means comprises means for defining the pacing interval to be the sum of the PVI, PVARP, ALI, P-track interval and a Wenkebach interval (WI), and wherein the P-wave tracking means further includes means for tracking a P-wave that occurs during the WI on a delayed basis.

25. The system of claim 24, wherein the timing means includes means for inserting the WI into the pacing interval so that it follows the ALI.

26. The system of claim 24, wherein the timing means includes means for inserting the WI into the pacing interval so that it follows the PVARP, with the ALI following the WI.

27. The system of claim 22, wherein the average rate limiting means comprises:

timing means for defining a maximum mean rate interval (MMRI);

free-running means for repeating the MMRI over and over without synchronization to any other events; and

means for preventing more than one V-pulse from being generated during each MMRI;

whereby the average ventricular rate is limited to a value that is equal to 1/MMRI.

28. The system of claim 22, wherein the average rate limiting means comprises:

timing means for defining a maximum mean rate interval (MMRI);

free-running means for repeating the MMRI over and over without synchronization to any other events; and

means for tracking one and only one P-wave during each MMRI;

whereby the average ventricular rate, which is set by the rate of the tracked P-waves, is limited to a value that is equal to 1/MMRI.

29. A dual-chamber implantable pacemaker operable in a P-tracking mode, the pacemaker including means for sensing P-waves, and means for generating V-pulses, comprising:

P-wave tracking means for providing a ventricular rate that tracks sensed P-waves;

upper rate limiting means for limiting the P-wave tracking means so that P-waves are tracked only up to a maximal tracking rate; and

means for limiting a maximal mean ventricular rate to a value that is less than the maximal tracking rate.

30. A method of maintaining synchrony between atrial events and ventricular stimulation in an implantable pacemaker, the pacemaker having means for sensing atrial events, and means for generating a ventricular stimulation pulse (V-pulse), comprising:

(a) generating a recurring cycle of tracking periods of T seconds each that runs independent of any sensed events;

(b) tracking only a first sensed atrial event in each tracking period by;

(i) starting a PV interval upon the sensing of the first sensed atrial event in the tracking period, and (ii) generating a V-pulse at the conclusion of the PV interval; and

(c) not tracking any subsequent sensed atrial events that occur during a tracking period wherein a first sensed atrial event has already been tracked;

whereby the average rate of generating V-pulses in synchrony with sensed atrial events is 1/T pulses per second.

31. The method of claim 30, wherein T comprises a period of time ranging from 300 to 600 milliseconds.

32. The method of claim 30, wherein the pacemaker includes means for determining a pacing interval, and further including using the method set forth in claim 30 only when the pacing interval is less than a programmable threshold of y seconds, where the programmable threshold of y seconds is selected to define an upper rate limit above which the method is used, and below which the method is not used.

33. A method of maintaining synchrony between atrial events and ventricular stimulation in a dual-chamber implantable pacemaker, the pacemaker having means for sensing atrial events and ventricular events, and means for generating a ventricular stimulation pulse (V-pulse), said method comprising:

(a) generating a recurring cycle of tracking periods of T seconds each that runs independent of any sensed events;

(b) tracking a sensed atrial event in each tracking period by;

(i) starting a PV interval upon the sensing of the sensed atrial event in the tracking period,

(ii) generating a V-pulse at the conclusion of the PV interval when ventricular activity has not already occurred during the tracking period, and

(iii) inhibiting the generation of a V-pulse at the conclusion of the PV interval when ventricular activity has already occurred during the tracking period;

whereby the average rate of generating V-pulses in synchrony with sensed atrial events is 1/T pulses per second.

34. The method of claim 33, wherein T comprises a period of time ranging from 300 to 600 msec.

35. A method of operating an implantable pacemaker to synchronize atrial depolarization with a paced ventricular depolarization, said pacemaker including means for sensing atrial and ventricular depolarizations, and means for generating a ventricular stimulation pulse (V-pulse) at a set time following the atrial depolarization, the V-pulse being adapted to force a ventricular depolarization, the method comprising the steps of:

(a) defining a maximum mean rate interval (MMRI) that sets the fastest average rate at which the pacemaker is to pace a patient'"'"'s heart;

(b) starting a recurring cycle of MMRI intervals by starting a first MMRI interval at any time, starting a second MMRI interval at the conclusion of the first MMRI interval, starting a third MMRI interval at the conclusion of the second MMRI interval, and so on, with an (n+1)th MMRI interval being started at the conclusion of an nth MMRI interval, where n is an integer, with the cycle of MMRI intervals thus established running independent of other timed or sensed events within the pacemaker; and

(c) generating a V-pulse at the set time following the atrial depolarization no more than once during each MMRI interval.

36. The method of claim 35, wherein the step of generating the V-pulse no more than once during each MMRI comprises:

(1) monitoring the number of atrial depolarizations that occur during each MMRI,

(2) starting a PV interval upon the occurrence of the first atrial depolarization of each MMRI, but not starting the PV interval upon the occurrence of any subsequent atrial depolarization within such MMRI, and

(3) generating the V-pulse at the conclusion of the PV interval.

37. The method of claim 35, wherein the step of generating the V-pulse no more than once during each MMRI comprises:

(1) monitoring each MMRI for the occurrence of a ventricular depolarization, and

(2) inhibiting the generation of any V-pulse that would cause a second ventricular depolarization to occur within an MMRI during which a prior V-pulse was generated.

38. The method of claim 37, wherein the MMRI has a value of between 300 and 600 milliseconds.

39. A dual-chamber implantable pacemaker comprising:

sensing means for sensing an atrial depolarization (P-wave) and a ventricular depolarization (R-wave) within a patient'"'"'s cardiac cycle;

pulse generating means for generating a ventricular stimulation pulse (V-pulse);

control means for controlling the sensing means and pulse generating means so as to maximize the number of cardiac cycles during which the generation of a V-pulse is synchronized with atrial activity, said control means including;

means for generating a PV interval that defines the time between a sensed P-wave and a V-pulse,

means for inhibiting the generating of a V-pulse at the conclusion of the PV interval in the event an R-wave is sensed before the timing out of the PV interval,

means for generating a cycle of maximum mean rate intervals (MMRI'"'"'s) that runs asynchronously relative to the sensing means and pulse generating means, with a new MMRI commencing at the conclusion of a prior MMRI, and

means for preventing the generation of a V-pulse within a given MMRI of the cycle of MMRI'"'"'s if either an R-wave or V-pulse has already occurred within the given MMRI,

whereby at most only one ventricular depolarization is caused by said pacemaker during each MMRI.

40. The dual-chamber implantable pacemaker, as set forth in claim 39, wherein the means for preventing the generation of a V-pulse within a given MMRI comprises means for starting a PV interval following only a first P-wave of a given MMRI, and not starting the PV interval following a subsequent P-wave of the given MMRI, whereby the subsequent P-wave of the given MMRI is ignored and does not result in the generation of a V-pulse.

41. The dual-chamber implantable pacemaker, as set forth in claim 39, wherein the means for preventing the generation of a V-pulse within a given MMRI comprises means for counting the number of ventricular depolarizations that occur within a given MMRI, and means for inhibiting the generation of any V-pulse which would result in the generation of a second V-pulse within the given MMRI.

42. The dual-chamber implantable pacemaker, as set forth in claim 39, wherein said MMRI comprises a programmable interval that is set to a value of between 300 to 600 milliseconds.

43. The dual-chamber implantable pacemaker, as set forth in claim 39, wherein the pacemaker further includes means for sensing a physiological parameter, and wherein said MMRI comprises a variable interval that varies between 300 to 600 milliseconds as a function of the physiological parameter.

44. The dual-chamber implantable pacemaker, as set forth in claim 39, wherein said control means further includes:

means for determining an atrial rate, the atrial rate being determined as a function of the average time interval between atrial depolarizations,

means for adjusting the PV interval as a function of the atrial rate, with PV interval being made shorter as the atrial rate increases.

45. A dual-chamber pacemaker for stimulating the heart of a patient, said pacemaker comprising:

an atrial channel that includes means for sensing P-waves;

a ventricular channel that includes means for sensing R-waves and means for generating and delivering ventricular stimulation pulses (V-pulses);

control means for controlling the atrial channel and the ventricular channel to operate in a dual-chamber mode of operation, said control means comprising;

timing means for defining a pacing cycle made up of a plurality of timed periods, said timed periods including a post ventricular atrial refractory period (PVARP) that begins with a ventricular event, said ventricular event comprising either a sensed R-wave or a generated V-pulse, and

upper rate limiting means for limiting the maximum mean rate of the pacing cycle, the maximum rate being defined by a maximum mean rate interval (MTR), said upper rate limiting means comprising;

means for generating a continuous MMRI sequence with one MMRI beginning immediately after the conclusion of a preceding MMRI, said MMRI sequence being asynchronous relative to said timing means, and

means for limiting the number of V-pulses that may occur during each MMRI of the sequence to no more than one,

whereby V-pulses may not be generated by the ventricular channel at a rate that is, on average, any faster than the maximum rate defined by the MMRI.