1. Field of the Invention
The invention relates to cardiac pacemakers and more particularly to a dual chamber pacemaker which varies the pacer V-A escape interval in response to the timing of the patient's atrial activity.
2. Description of the Prior Art
The first pacemakers were asynchronous These VOO mode pacemakers are typified by U.S. Pat. No. 3,057,356 to Greatbatch. Such pacers operate independently of intrinsic heart activity and pace the ventricle at a metronomic rate. Although such pacemakers provide a ventricular pacing rate sufficient to support life, these pacemakers can compete with intrinsic ventricular rhythms which can prove hazardous to the patient.
The VVI mode or ventricular demand pacemaker, as typified by U.S. Pat. No. 3,478,746 to Greatbatch, was introduced to reduce competitive pacing with naturally occurring ventricular rhythms. This ventricular inhibited form of pacemaker provides a ventricular sense amplifer responsive to ventricular depolarizations. The ventricular sense event recycles the V--V timer of the pacemaker. At the conclusion of the V--V time interval, the pacemaker stimulates the ventricle unless inhibited from doing so by a ventricular sense event occuring within the V--V interval.
The VAT mode pacemaker as typified by U.S. Pat. No. 3,254,596 to Keller provides an atrial sense amplifier responsive to atrial depolarizations which starts an A-V timer within the pacemaker. At the conclusion of this A-V time interval, the pacemaker generates a ventricular pacing pulse which is delivered to the ventricle. This stimulus is synchronized with the naturally occurring atrial beat. Therefore, this atrial synchronized form of ventricular pacemaker provides a prosthetic conduction pathway mimicking the natural pathway of the heart by providing a paced ventricular rhythm in response to and synchronized with the detected atrial rate. A defect of this pacing modality is the ability to compete with ectopic ventricular activity. An ectopic ventricular beat will be sensed in the atrium and treated as though it were an atrial event. This will result in the generation of a ventricular pacing stimulus a fixed A-V delay after the atrially detected ventricular event. Although such competitive pacing is considered harmless when the A-V delay of the VAT pacemaker is short, such a pacing regime can result in delivery of a ventricular pacing stimulus into the vulnerable period of the R-waves which is undesirable.
The VDD mode pacemaker, as typified by U.S. Pat. No. 3,648,707 to Greatbatch, overcomes this drawback of the VAT mode pacemaker by providing a ventricular sense amplifier responsive to ventricular depolarizations for inhibiting an otherwise scheduled ventricular pacing event by the pacemaker. In operation, the VDD pacemaker may sense atrial depolarizations through an atrial sense amplifier which starts an A-V timer. The A-V timer schedules the generation of a ventricular pacing pulse one A-V interval after the detected atrial signal. The scheduled stimulation, however, may be interrupted or inhibited by the detection of a naturally occurring ventricular event detected by the ventricular sense amplifier. In the absence of either atrial or ventricular rhythms, the VDD pacemaker will pace the ventricle at a metronomic rate. However, in the presence of a sinus atrial rhythm, the VDD pacemaker will pace the ventricle in synchrony with the detected atrial rhythm.
The DVI mode A-V sequential pacemaker, as typified by U.S. Pat. No. 3,595,242 to Berkovits, provides for stimulation in both the atrium and ventricle while providing for ventricular sensing. In this form of pacemaker, a ventricular sense event initiates a V-A timer as well as a V-V timer. At the expiration of the V-A interval, the pacemaker generates an atrial pace event, and at the expiration of the V--V interval, the pacemaker generates a ventricular pace event. If a ventricular event occurs during the V-A or V--V time, the pacemaker is inhibited and recycled so that the V-A and V--V timer restart. This bifocal form of pacemaker preserves the hemodynamic advantages of sequential atrial and ventricular contractions.
The DDI mode pacer, as typified by U.S. Pat. No. 3,747,604 to Berkovits, includes a V-A and V--V timer and further includes an atrial sense amplifier for inhibiting the generation of an atrial pacing stimulus at the conclusion of the V-A interval if a naturally occurring atrial depolarization occurs within that time interval. This DDI mode of pacemaker, unlike the VAT or VDD pacemaker, does not resynchronize or restart the pacemaker's timer upon the sensing of arial events. Therefore, it does not provide the atrial tracking response exhibited by VAT and VDD devices.
Recently, dual sense-dual pace or DDD mode pacemakers, as typified by U.S. Pat. No. 4,312,355 to Funke, have been introduced to compensate for many of the disadvantages of the preceding forms of pacemakers and for providing more efficacious therapy in the event of an intermittent block during atrial pacing. The DDD pacemaker provides an atrial sense amplifier to generate an atrial sense signal that synchronizes the pacemaker by initiating an A-V timer. The A-V delay schedules the delivery of a ventriculr pace event unless a ventricular sense event occurs within the A-V interval to inhibit or cancel the scheduled ventricular pace event. This form of pacemaker also provides a ventricular sense amplifier for initiating a V-A timer in response to a ventricular sense signal which schedules the generation of an atrial stimulus at the conclusion of the V-A interval unless an atrial sense event occurs to cancel the ventricular pace event within the A-V interval.
This prior art DDD form of pacemaker is represented by the state diagram of FIG. 2. Assuming that the machine is in the atrial observation state 24 (AOT), then an atrial sense event (AS) causes state transition 11 which causes the machine to enter the A-V delay state 12 where the A-V delay timer starts to time out an atrial-ventricular escape interval. If the A-V delay timer (AVD) times out (AVTO), then state transition 14 takes place moving the machine to the ventricular pacing state (VP)16. In this state, the machine delivers a pacing stimulus to the ventricle of the heart. At the conclusion of the pacing pulse, the machine moves via transition 18 to the refractory state 20 during which time the post ventricular-atrial refractory period (PVARP) is timed out. At the conclusion of the post ventricular-atrial refractory period (PVARP), the machine moves via transition 22 to the atrial observation state (AOT). In this state, the pacer is responsive to the atrial sense amplifier as previously described. If atrial activity is not sensed, then the machine will leave the atrial observation state as indicated by state transition 26 whereupon entering the atrial pacing state 28, the machine generates an atrial pacing stimulus. At the conclusion of the pacing pulse reflected by transition 30, the machine re-enters the A-V delay state 12. If a ventricular sense event occurs during this state as indicated by state transition 32, the machine re-enters the refractory state 20.
This state machine description depicts the interaction of the pacer with the heart in response to the various cardiac events which may occur during the various timing cycles of the pacer.
Each of the previously discussed pacing modalities incorporates escape intervals defined as the time period extending from a sense event to the scheduled generation of a succeeding paced event, which are fixed at a discrete value during the operation of the pacer. Modern versions of each of these prior art pacemakers provide for the remote programming of such escape interval under the direction of a physician. However, once programmed, the intervals are not altered by pacemaker events.
Pacemakers have been proposed and built which alter the escape interval of the pacemaker in response to pacemaker detected cardiac events. An example of one such pacemaker is U.S. Pat. No. 4,052,991 to Zacouto as well as U.S. Pat. No. 28,341 to Gobeli. The Zacouto machine is a ventricular pacemaker with ventricular sensing which alters the V--V escape interval of the pacemaker depending upon the timing of naturally occurring ventricular events. This pacemaker measures the time interval from a ventricular pace event to a subsequent ventricular sense event and sets the escape interval of the pacemaker to that value. In operation, a Zacouto orthorhythmic pacemaker has a nomimal V--V escape interval which results in the metronomic pacing of the ventricle at that rate in the absence of detected atrial ventricular activity. When a ventricular sense event occurs, the orthorhythmic pacemaker may provide an escape interval longer than the nominal escape interval which Zacouto refers to as negative hysteresis. Alternatively the pacer may provide for a shorter escape interval than the nominal value, which Zacouto refers to as positive hysteresis. Consequently, the orthorhythmic pacemaker represents a pacemaker in which the escape interval of the pacemaker is altered on a beat-to-beat basis in response to the detection of ventricular cardiac activity.
The Gobeli pacemaker is a VVI device that exhibits positive hysteresis under the nomenclature of Zacouto since the escape interval of the pacemaker is lengthened in response to a detected ventricular sense event.
More recently, pacers have been proposed which alter the stimulation escape interval based on the evoked QT time interval. See, for example, U.S. Pat. No. 4,228,803 to Rickards and 4,305,396 to Wittkampf et al.