Pacesetter, Inc.

Kenneth Valikai

Jason A Sholder

Paul A Levine

Gene A Bornzin

Joseph J Florio

Gregory C Bevan

Gabriel A Mouchawar

Brian M Mann

Jeffery D Snell

James D Causey, Iii

Lisa P Weinberg

Allan R Schwartz

Leslie S Miller

J Kelly Fox

Azita M Rahbari

An implantable dual chamber stimulation device provides a novel detection scheme for automatically detecting atrial capture and performing an atrial pacing threshold assessment. The stimulation device preferably waits until the patient is at or near rest and monitors the patient's P-wave activity to determine a detection window where a next P-wave is expected to occur. The stimulation device then delivers an atrial pulse prior to the next detection window, and monitors the window to determine whether a P-wave occurs therein. If a P-wave does not occur, then atrial capture is present, while occurrence of a P-wave indicates absence of atrial capture. If atrial capture is absent, the stimulation device automatically determines an appropriate atrial pacing threshold by monitoring the detection window while adjusting the stimulation pulse energy level. Advantageously, the present invention further employs a 'bottom-up' adjusting scheme which starts at a low energy level, below the expected atrial pacing threshold, and increases the energy level until atrial capture is detected, thus saving energy and further avoiding corruption by large polarization signals. The latter feature is compatible with the present detection scheme and conventional evoked response detection schemes. The new atrial pacing threshold is then set at the atrial pulse level at which atrial capture was effectuated plus a predetermined safety margin.

System and method for automatic atrial capture detection and atrial pacing threshold determination

An implantable dual chamber stimulation device provides a novel detection scheme that automatically detecting atrial capture and performing an atrial pacing threshold assessment. The stimulation device preferably waits until the patient is at or near rest and monitors the patient's P-wave activity to determine a detection window where a next P-wave is expected to occur. The stimulation device then delivers an atrial pulse prior to the next detection window, and monitors the window to determine whether a P-wave occurs therein. If a P-wave does not occur, then atrial capture is present, while occurrence of a P-wave indicates absence of atrial capture. If atrial capture is absent, the stimulation device automatically determines an appropriate atrial pacing threshold by monitoring the detection window while adjusting the stimulation pulse energy level. Advantageously, the present invention further employs a &ldquo;bottom-up&rdquo; adjusting scheme which starts at a low energy level, below the expected atrial pacing threshold, and increases the energy level until atrial capture is detected, thus saving energy and further avoiding corruption by large polarization signals. The latter feature is compatible with the present detection scheme and conventional evoked response detection schemes. The new atrial pacing threshold is then set at the atrial pulse level at which atrial capture was effectuated plus a predetermined safety margin.

An implantable dual chamber stimulation device provides a novel detection scheme for automatically detecting atrial capture and performing an atrial pacing threshold assessment. The stimulation device preferably waits until the patient is at or near rest and monitors the patient's P-wave activity to determine an detection window where a next P-wave is expected to occur. The stimulation device then delivers an atrial pulse prior to the next detection window, and monitors the window to determine whether a P-wave occurs therein. If a P-wave does not occur, then atrial capture is present, while occurrence of a P-wave indicates absence of atrial capture. If atrial capture is absent, the stimulation device automatically determines an appropriate atrial pacing threshold by monitoring the detection window while adjusting the stimulation pulse energy level. Advantageously, the present invention further employs a &ldquo;bottom-up&rdquo; adjusting scheme which starts at a low energy level, below the expected atrial pacing threshold, and increases the energy level until atrial capture is detected, thus saving energy and further avoiding corruption by large polarization signals. The latter feature is compatible with the present detection scheme and conventional evoked response detection schemes. The new atrial pacing threshold is then set at the atrial pulse level at which atrial capture was effectuated plus a predetermined safety margin.

A single-pass pacing and/or shocking lead system is capable of sensing cardiac signal in the atrium and the ventricle in a &ldquo;bipolar fashion&rdquo; using a three-electrode structure: a first electrode in the atruim, a second electrode in the ventricle just below the tricuspid valve, and a third in the ventricle.

Implantable stimulation system for providing dual bipolar sensing using an electrode positioned in proximity to the tricuspid valve and programmable polarity

A dual-chamber implantable pacemaker is configured to operate in the DDD or DDDR mode with its AV (or PV) interval automatically set to be a small time interval less than the natural conduction time of a patient. The pacemaker shortens the AV (or PV) interval in response to a verified R-wave occurring within the AV (PV) interval, which it discriminates from an ectopic R-wave by requiring the occurrence of at least three consecutive R-waves or, alternatively, the occurrence of an R-wave having a morphology that matches the morphology of a reference R-wave stored in the pacemaker's memory. When the AV (or PV) interval is set to a value that is less than the natural conduction time, preemptive ventricular pacing.

Dual-chamber implantable pacemaker having negative AV/PV hysteresis and

Preemptive tachyarrhythmia pacing is provided in an implantable cardiac-stimulation device, such as an implantable pacemaker or defibrillator, by modifying the operation of the implantable device in a way that minimizes the likelihood of occurrence of a tachyarrhythmia. The behavior modification is achieved through the use of an appropriate preemptive tachyarrhythmia pacing control routine stored within the memory of the device. Depending upon the needs of the patient, preemptive tachyarrhythmia pacing is invoked continuously or on demand. If invoked on demand, Preemptive tachyarrhythmia pacing is triggered only upon the sensing of one or more conditions suggest that the onset of a tachyarrhythmia is imminent. When thus invoked, preemptive tachyarrhythmia pacing remains invoked only for as long as the onset-of-a-tachyarrhythmia-is-imminent conditions persist. Various preemptive tachyarrhythmia pacing control routines are contemplated, including those based on overdrive pacing, pacing with randomicity, and mode switching. Overdrive pacing, when used, is based on an automatically-determined diurnal rate, an automatic stepped increase over the average atrial rate, or a rate set by a cycle-to-cycle negative hysteresis. Conditions which suggest the imminency of the onset of a tachyarrhythmia include, but are not limited to, a sudden change in the patient's cardiac cycle from a previously-determined normal cardiac cycle.

Implantable stimulation device having means for operating in a

A single-pass tripolar pacing/lead system for pacing and sensing electrical activity in the heart of a patient in one of a VDD or VDDR fashion. The lead system is capable of bipolar sensing of the atrium and the ventricle using a three electrode structure: a first electrode in the atrium, a second in the ventricle just below the tricuspid valve, and a third in the ventricle. The lead system also is capable of providing bipolar stimulation of the ventricle.

Implantable stimulation system having a single-pass, tripolar lead and

Event/rate data gathered by an implantable pacemaker is displayed in a histogram format as a function of heart rate and event type, with multiple events being included in the display of each rate bin of the histogram. Event types include a paced event, a sensed event, or a premature ventricular event (PVE). Two types of histograms are provided: (1) a heart rate histogram that shows the occurrence of each event type in each heart rate bin as a function of the percent of total events in all heart rate bins; and (2) a histogram that shows event type distribution by rate bin.

Multi-event bin heart rate histogram for use with and implantable

A system and method for pulse modulating a cardiac pacing signal provides a way to have the pulse modulation characteristics be descriptive of critical information relating to the operational performance of an implanted pacemaker. The patient's ECG/EKG signal is modulated by varying the pulse-intervals of a prescribed plurality of ventricular stimulation pulses in a manner descriptive of important pacer/patient information, such as Pacemaker Battery Status, Pacemaker Sensor Function, Impedance of the Atrial Lead, Impedance of the Ventricular Lead, Existence of Specified Rhythmic Conditions, Indicated Extrsystoles Rates, and other related parameters. The resulting pulse-modulated signal is suitable for transtelephonic transmission to remote locations for subsequent demodulation and analysis. The preferred method comprises the steps of determining or measuring parametric information for selected pacemaker parameters of the implanted pacemaker, varying the pulse characteristics (i.e. timing intervals) of the ventricular stimulation pulses generated by the implanted pacemaker to be descriptive of the parametric information for the selected pacemaker parameters, and triggering the generation of a prescribed plurality of ventricular stimulation pulses having such descriptive pulse characteristics.

Descriptive transtelephonic pacing intervals for use by an emplantable

An implantable device programmer includes a variety of features for allowing a clinician to perform an automated and customized follow-up examination of a patient having an implanted cardiac implantable device, the implantable device being of the type which captures and stores various types of diagnostic data for subsequent retrieval and evaluation. A custom protocol feature of the programmer allows the clinician pre-specify and then semi-automatically follow an ordered sequence of protocol steps, each protocol step involving the interrogation of the implantable device and the display by the programmer of associated implantable device data (such as a heart rate histogram, or the results of a ventricular capture test). When the clinician initiates a custom protocol, the programmer automatically retrieves all of the diagnostic data records of the protocol in the protocol order. This automatic retrieval is performed in the background, allowing the clinician to begin viewing the initial diagnostic data records of the protocol while the other items are being retrieved. Via a user interface of the programmer, the clinician can rapidly and efficiently sequence through the data display screens associated with the protocol, to thereby view the various diagnostic data records and/or perform the various diagnostic tests of the protocol.

Growing community of inventors

Palos Verdes Pen., CA, United States of America

Kenneth Valikai