Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
2002-02-25
2004-05-04
Getzow, Scott M. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
Reexamination Certificate
active
06731983
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to cardiac pacemakers. More particularly, the present invention relates to cardiac pacemakers having improved methods for detecting arrhythmias.
BACKGROUND OF THE INVENTION
An arrhythmia is a heart rhythm disorder which interferes with the life sustaining blood pumping action of the heart. Examples of arrhythmias include ventricular tachycardia and atrial tachycardia. Ventricular tachycardia effects the lower chambers of the heart, the ventricles, and atrial tachycardia effects the upper chambers of the heart, the atria. Ventricular tachycardia is a rapid heart beat initiated within the ventricles, characterized by three or more consecutive premature ventricular beats. Ventricular tachycardia is a potentially lethal arrhythmia, as it may cause the heart to become unable to pump adequate blood through the body. Companies such as Medtronic, Inc., have developed implantable pacemakers which may be used to successfully treat ventricular tachycardia by delivering ventricular pacing pulses to the heart when ventricular tachycardia is detected.
Dual chamber pacing modes have been widely adopted for pacing therapy. Among the dual chamber operating modes is the “DDD” mode, which can pace an atrium and a ventricle, senses both the atrium and the ventricle, and can either inhibit or trigger pacing stimuli for both chambers. This mode has a sensor augmented variant mode called “DDDR”, where the “R” stands for rate-adaptive or rate modulation.
A DDD pacemaker includes an atrial sense amplifier to detect atrial depolarizations of the heart, and a ventricular sense amplifier to detect ventricular depolarizations of the heart. If the atrium of the heart fails to beat within a predefined time interval (atrial escape interval), the pacemaker supplies an atrial stimulus to the atrium through an appropriate lead system. Following an atrial event (either sensed or paced) and an atrioventricular (A-V or A2V) interval, the pacemaker supplies a ventricular pacing stimulus to the ventricle through an appropriate lead system, if the ventricle fails to depolarize on its own. Pacemakers which perform this function have the capability of tracking the patient's natural sinus rhythm and preserving the hemodynamic contribution of the atrial contraction over a wide range of heart rates.
Various types of pacemakers are disclosed in the prior art, and are presently in widespread use. The pacing literature has documented the different types of pacemakers and their characteristics extensively. A summary of the evolution and characteristics of pacemaker types, and specifically different types of dual chamber pacemakers, is set forth in U.S. Pat. No. 4,951,667, which is incorporated herein by reference.
Another and more recent advance in the field of cardiac pacing systems is that of the rate responsive pacemaker which increases cardiac output in response to exercise or other body demands. Such pacemakers may control pacing rate based upon sensing any one or a combination of different body parameters such as body activity, blood pH, respiratory rate, QT interval or historical atrial activity. See, for example, U.S. Pat. No. 4,428,378, (Anderson et al.), disclosing a pacemaker which varies pacing rate in response to sensed patient activity; and U.S. Pat. No. 4,228,308, (Rickards), which discloses controlling pacing rate in response to Q-T interval. Additionally, rate responsive control has been integrated into dual chamber pacing systems, e.g., DDDR and DDIR systems. See “Rate Responsive Dual Chamber Pacing” in PACE, vol. 9, pp. 987-991;U.S. Pat. No. 4,467,807, Bornzin; and the above-noted U.S. Pat. No. 4,951,667.
Background information directly related to the present invention may be discussed in greater detail. The atrium may be paced with an A-pace. The energy from the A-pace may be sensed by the ventricle amplifier as a V-sense event. This is referred to as an over-sense or cross-chamber sensing. It is not really a contraction of the ventricle, but is rather the electrical activity of the atrium being detected by the sensor in the ventricle. In this situation, the ventricle may not have actually contracted. If the V-sense event is too close to the A-pace event, a ventricular safety pace (VSP) stimulation pulse is given to the ventricle, in case the V-sense was actually an indication of a premature ventricular contraction, which might continue as ventricular tachycardia.
In many patients, it would be desirable to wait until closer in time to the expected time of a natural ventricular contraction. However, waiting too long would put the VSP pulse at about the same point in time as the T-wave, which would be undesirable, as pacing in the middle of the T-wave may cause an arrhythmia. The VSP pulse is given because of a premature V-sense, which is believed to not be an indication of an actual ventricular contraction. If the V-sense reflected a real ventricular contraction, there would be nothing seen from the ventricle until the next natural event. Therefore, waiting a long period would gain nothing. If the V-sense was an over-sense, then waiting for the V-sense reflecting an actual ventricular contraction would require waiting too long, putting any required V-pace too close to the T-wave. Thus, in this situation, while it is not known that the V-sense reflected an actual premature ventricular contraction, it is desirable that the ventricle contract. Therefore the VSP pulse will be generated to ensure that the ventricle contracts.
When a pacemaker is operated in DDD mode, the atrium is paced in the absence of a sensed natural event. After the A-pace, there is a time period, a trigger window, within which a V-sense may be detected. If a V-sense is detected during this window, then a VSP pulse will be scheduled, at the end of the VSP timing window or interval.
In one example, where a desired pacing rate of about 120 beats per minute is desired, the VSP, if it is to occur at all, will be scheduled at about 60 milliseconds after the A-pace. In the example where a slower desired pacing rate of about 60 beats per minute is desired, the VSP, if it is to occur at all, is scheduled at about 110 milliseconds after the A-pace. The VSP is normally scheduled no longer than about 80 milliseconds after the V-sense, to avoid being too close to the T-wave. In the absence of any V-sense event within the trigger window after the A-pace, the next scheduled V-pace would not normally occur for a longer period, for example, about 150 milliseconds. This interval from the A-pace to the V-pace can be based on the PAV interval.
In a paced, cardiac cycle, there may be three blanking periods where the pacemaker is unable to sense arrhythmias. The first blanking period follows the A-pace. The second blanking period follows a V-sense, as it is undesirable for the pacing device to double count the V-sense event. The third blanking period follows the V-pace. Thus,, if there is a ventricular arrhythmia occurring at a fast rate, the pacing device may see only every other beat, resembling a normal heart beat.
It would be desirable to provide an algorithm that favors detection over pacing in a stronger way than is proposed in the previous disclosure. It is further desirable to provide a system in which the detection window is long enough contemporaneous with evidence of an arrhythmia. It would also be desirable to provide a long interval between a ventricular event and the next scheduled atrial pace such that the atrial pace does not interfere, with detection.
SUMMARY OF THE INVENTION
The present invention provides improved methods for cardiac pacing that may find particular use in pacing situations having high pacing rates that would otherwise have substantially shortened windows for detecting arrhythmias and/or pacing situations forced to accept slow pacing rates to maintain long windows for detecting arrhythmias.
In accordance with the improved aspect of the invention, in the event there is detection or an evidence of an arrhythmia, a device-implemented software system opens a detec
Betzold Robert A.
Condie Catherine R.
Ericksen James H.
Gillberg Jeffrey M.
Jackson Troy E.
Getzow Scott M.
Medtronic Inc.
Soldner Michael C.
Wolde-Michael Girma
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