Pacesetter, Inc.

Packsetter, Inc.

Janice Barstad

Joseph J Florio

Gene A Bornzin

Peter Boileau

Eric Falkenberg

Kerry A Bradley

Kevin L Morgan

Richard M Lu

Sheldon Williams

Harold C Schloss

Gregory C Bevan

An implantable cardiac stimulation device, such as a pacemaker or Implantable Cardioverter Defibrillator, is configured to automatically monitor the effects of antiarrhythmic drugs on cardiac electrical signals within a patient to verify the efficacy of the drugs taken. In one example, an analysis of patient cardiac electrical signals is performed by comparing the cardiac electrical signals with values representative of the effects of different classes of antiarrhythmic drugs. If the implantable device determines that the prescribed antiarrhythmic drugs have not been effective, a warning signal is generated. The warning signal is conveyed directly to the patient via a bedside monitor and to the patient's physician via remote connection to an external programmer device so that both are notified of the drug efficacy problems. Additionally, the implantable device may be configured to automatically adjust pacing and defibrillation control parameters in an attempt to compensate for any lack of efficacy in the drugs. For example, the aggressiveness of overdrive pacing may be increased. Alternatively, a drug pump is controlled to adjust the dosage of antiarrhythmic drugs if an initial dosage is found to be ineffective.

Method and apparatus for monitoring drug effects on cardiac electrical signals using an implantable cardiac stimulation device

An omnidirectionally steerable obturator facilitates the delivery of the distal tip of an introducer sheath into the coronary sinus of a heart. The steerable obturator comprises an obturator body extending longitudinally along a central axis, the obturator body being configured to be received by the introducer sheath. The obturator body further has a flexible, deflectable distal end section terminating in a rounded distal tip. An actuator, controllable from a proximal end of the obturator body, is operatively associated with the flexible distal end section of the obturator body to cause deflection of the flexible distal end section of the obturator body in at least one selected direction to facilitate passage of the distal end section of the obturator body and the distal tip of the introducer sheath into the coronary sinus of the heart. The obturator body is preferably configured to be received in a close fit within at least the tip of the introducer sheath. More preferably, the distal end of the obturator body has an outer surface and the fit between the outer surface of the obturator and at least the tip of the introducer sheath comprises substantially a line-to-line fit.

Steerable obturator

An implantable cardiac stimulation device is described wherein a controller of the cardiac stimulation device controls selected functions of the device based on whether the patient is at rest and further based on whether the patient is prone to vagally-mediated arrhythmias. Functions of the device that may be controlled include, for example, a pacing base rate, an AV/PV delay, and a refractory period as well as overdrive pacing parameters and diagnostic data gathering parameters. In one example, if the patient is not prone to vagally-mediated arrhythmias, the base rate is lowered while the patient is at rest. Also, overdrive pacing parameters are set to be less aggressive. As such, the operation of the cardiac stimulation device is controlled to make it easier for the patient to rest while also reducing power consumption. However, if the patient is prone to vagally-mediated arrhythmias, the base rate is not lowered while the patient is at rest. Overdrive pacing parameters are instead set to be more aggressive, rather than less aggressive. In this manner, the cardiac stimulation device attempts to compensate for any increased risk of arrhythmia that may occur while the patient, who is prone to vagally-mediated arrhythmias, is at rest. Numerous other parameters may be adjusted dependent upon whether the patient is at rest or dependent upon whether the patient is prone to vagally-mediated arrhythmias.

Method and apparatus for using a rest mode indicator to automatically adjust control parameters of an implantable cardiac stimulation device

Systems and methods are provided for collecting enhanced diagnostic information specifically pertaining to overdrive pacing within an implantable cardiac stimulation device and for processing and displaying the enhanced diagnostic information using an external programmer. The enhanced diagnostic information includes one or more of overdrive pacing efficacy, overdrive pacing percentage, overdrive pacing/heart rate histogram data, longest recovery duration, atrial event data, minimum/maximum/average of the overdrive pacing rate, number of paced beats at maximum rate, duration of recovery time from maximum rate, intrinsic rate breakthrough histogram data, and number of rate increases. By tracking and displaying the enhanced diagnostic information, a physician can thereby more effectively and reliably program overdrive pacing control parameters to achieve optimal overdrive pacing performance.

Detecting and displaying diagnostic information pertaining to dynamic atrial overdrive pacing

Dynamic overdrive pacing adjustment techniques are described for use in implantable cardiac stimulation devices. In a first technique, an overdrive pacing unit of a microcontroller of the implantable device operates to optimize various control parameters that affect overdrive pacing so as to achieve a desired degree of overdrive pacing for the particular patient in which the stimulation device is implanted. Parameters to be optimized include the number of overdrive beats paced once overdrive pacing is trigged, the overdrive pacing response function, the recovery rate, and various base rates. The control parameters are adjusted in a hierarchical order of priority until the desired degree of overdrive pacing is achieved. Adjustment of the number of overdrive beats, the recovery rate, and various base rates is iteratively performed by using incremental numerical adjustments. Adjustment of the overdrive pacing response function may be performed by selecting among a set of fixed predetermined linear response functions. In a second technique, the overdrive pacing unit operates to optimize the shape of a single non-linear dynamic overdrive pacing response function so as to achieve the desired degree of overdrive pacing for the patient. The second technique may either be employed alone or in combination with the first, hierarchical optimization technique.

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Eden Prairie, MN, United States of America

Janice Barstad