Abstract: A cardiac electro-stimulatory device and method for operating same in which stimulation pulses are distributed among a plurality of electrodes fixed at different sites of the myocardium in order to reduce myocardial hypertrophy brought about by repeated pacing at a single site and/or increase myocardial contractility. In order to spatially and temporally distribute the stimulation, the pulses are delivered through a switchable pulse output configuration during a single cardiac cycle, with each configuration comprising one or more electrodes fixed to different sites in the myocardium.

Abstract: A method for monitoring a biological cardiac pacemaker is provided. The method may include stimulating a heart at a region selected for implantation of a biological pacemaker and sensing at least one electrical signal indicative of a cardiac depolarization originating in the region selected for implantation of the biological pacemaker. The method may further include sensing at least one subsequent electrical signal produced by the heart and determining if the subsequent electrical signal originated in the region selected for the biological pacemaker or another region of the heart. In an alternative embodiment, the method may include determining a template time difference between two points on cardiac complexes sensed in two or more different cardiac locations during normal sinus rhythm. The method may further include determining a time difference between two points on a subsequent cardiac complex sensed in two or more different cardiac locations.

Abstract: An implantable device for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with leadless heart rate monitoring is provided. A stimulation therapy lead includes helical electrodes configured to conform to an outer diameter of a cervical vagus nerve sheath, and a set of connector pins electrically connected to the helical electrodes. A neurostimulator includes an electrical receptacle into which the connector pins are securely and electrically coupled. The neurostimulator also includes a pulse generator configured to therapeutically stimulate the vagus nerve through the helical electrodes in alternating cycles of stimuli application and stimuli inhibition that are tuned to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes by triggering bi-directional action potentials.

Abstract: A vagus nerve neurostimulator system with multiple patient-selectable modes for treating chronic cardiac dysfunction is provided. An implantable neurostimulator includes a pulse generator coupled to a therapy lead terminated by a pair of helical electrodes positioned over a cervical vagus nerve. The pulse generator is configured to deliver through the helical electrodes continuously-cycling, intermittent and periodic electrical stimulation that is parametrically defined to bi-directionally propagate through nerve fibers in the cervical vagus nerve. The implantable neurostimulator includes a magnetic switch configured to switch the pulse generator between a plurality of operating modes that are each separately selectable in response to a unique and remotely-applied magnetic signal. An external controller includes patient-actuatable controls configured to enable selection of one of the operating modes of the pulse generator.

Abstract: A method and device for delivering ventricular resynchronization pacing therapy in conjunction with electrical stimulation of nerves which alter the activity of the autonomic nervous system is disclosed. Such therapies may be delivered by an implantable device and are useful in preventing the deleterious ventricular remodeling which occurs as a result of a heart attack or heart failure. The device may perform an assessment of cardiac function in order to individually modulate the delivery of the two types of therapy.

Abstract: An implantable device for facilitating control of electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction is provided. A stimulation therapy lead includes helical electrodes configured to conform to an outer diameter of a cervical vagus nerve sheath, and a set of connector pins electrically connected to the helical electrodes. A neurostimulator includes an electrical receptacle into which the connector pins are securely and electrically coupled. The neurostimulator also includes a pulse generator configured to therapeutically stimulate the vagus nerve through the helical electrodes in alternating cycles of stimuli application and stimuli inhibition that are tuned to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes by triggering bi-directional action potentials.

Abstract: An implantable device for evaluating autonomic cardiovascular drive in a patient suffering from chronic cardiac dysfunction is provided. A stimulation therapy lead includes helical electrodes configured to conform to an outer diameter of a cervical vagus nerve sheath, and a set of connector pins electrically connected to the helical electrodes. A neurostimulator includes an electrical receptacle into which the connector pins are securely and electrically coupled. The neurostimulator also includes a pulse generator configured to therapeutically stimulate the vagus nerve through the helical electrodes in alternating cycles of stimuli application and stimuli inhibition that are tuned to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes by triggering bi-directional action potentials. The neurostimulator includes a recordable memory storing a baseline heart rate.

Abstract: A computer-implemented system and method for selecting therapy profiles of electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction is provided. An external programmer includes a plurality of therapy profiles stored in memory. The therapy profiles include different sets of stimulation parameters that cooperatively define alternating cycles of stimuli application and stimuli inhibition for a neurostimulator that are tuned to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes. A programming wand is configured to provide the set of stimulation parameters chosen by the user to the neurostimulator through wireless telemetry. Finally, an implantable neurostimulator device includes a stimulation therapy lead terminated by helical electrodes and electrically coupled to the neurostimulator.

Abstract: An implantable device for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with bounded titration is provided. A stimulation therapy lead includes helical electrodes configured to conform to an outer diameter of a cervical vagus nerve sheath, and a set of connector pins electrically connected to the helical electrodes. A neurostimulator includes an electrical receptacle into which the connector pins are securely and electrically coupled. The neurostimulator includes a pulse generator configured to therapeutically stimulate the vagus nerve through the helical electrodes in alternating cycles of stimuli application and stimuli inhibition that are tuned to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes by triggering bi-directional action potentials.

Abstract: An apparatus for reversing ventricular remodeling with electro-stimulatory therapy. A ventricle is paced by delivering one or more stimulatory pulses in a manner such that a stressed region of the myocardium is pre-excited relative to other regions in order to subject the stressed region to a lessened preload and afterload during systole. The unloading of the stressed myocardium over time effects reversal of undesirable ventricular remodeling.

Abstract: A cardiac rhythm management system for providing a plurality of therapy modalities. For example, the system may include a cardiac resynchronization therapy module for providing cardiac resynchronization therapy and a pacemaker module for providing bradycardia therapy, as well as a selector module coupled to the cardiac resynchronization therapy module and the bradycardia module. The selector module may select an operating mode from among a plurality of operating modes including the cardiac resynchronization therapy module and the pacemaker module. Various manual and automatic methods may be used to select the operating mode. In addition, a reversion management system may be included to assist the cardiac rhythm management system to recover in case of a disruption to the system.

Abstract: An apparatus and method for adjusting the performance of an implanted device based on data including contextual information. Contextual information, including operational and performance data concerning the implanted device as well as the patient with the implanted device, is stored by a portable electronic device. In one embodiment, the portable electronic device is adapted for battery operation and includes a personal digital assistant (PDA). The portable electronic device is adapted for use as an interface to conduct wireless communications with the implanted device. In one embodiment, the portable electronic device interfaces with a clinical programmer for use by a physician.

Abstract: Systems and methods for sleep state classification involve detecting conditions related to sleep, including at least one condition associated with rapid eye movement (REM) sleep. Additionally, a condition modulated by the sleep-wake status of the patient may be detected. A medical system that is partially or fully implantable incorporates sensors and circuitry for detecting and processing the sleep-related signals. A sleep state processor classifies the patient's sleep state based on the sleep-related signals. Sleep state classification may be used in connection with the delivery of sleep state appropriate therapy, diagnostic testing, or patient monitoring.

Abstract: Systems and methods for sleep state classification involve detecting conditions related to sleep, including at least one condition associated with rapid eye movement (REM) sleep. Additionally, a condition modulated by the sleep-wake status of the patient may be detected. A medical system that is partially or fully implantable incorporates sensors and circuitry for detecting and processing the sleep-related signals. A sleep state processor classifies the patient's sleep state based on the sleep-related signals. Sleep state classification may be used in connection with the delivery of sleep state appropriate therapy, diagnostic testing, or patient monitoring.

Abstract: An apparatus and method for adjusting the performance of an implanted device based on data including contextual information. Contextual information, including operational and performance data concerning the implanted device as well as the patient with the implanted device, is stored by a portable electronic device. In one embodiment, the portable electronic device is adapted for battery operation and includes a personal digital assistant (PDA). The portable electronic device is adapted for use as an interface to conduct wireless communications with the implanted device. In one embodiment, the portable electronic device interfaces with a clinical programmer for use by a physician.

Abstract: Methods and devices for delivering cardiac therapy to a patient are provided. Various implantable device embodiments comprise a plurality of leads and a controller. The leads include at least one lead to be positioned within a lead path to deliver ventricular pacing pulses and to deliver neural stimulation at a site proximate to the heart to inhibit sympathetic nerve activity. The controller controls delivery of the ventricular pacing pulses in accordance with a programmed pacing mode and controls delivery of the neural stimulation. The controller is programmed to deliver remodeling control therapy (RCT) by delivering ventricular pacing to pre-excite a ventricular myocardium region to mechanically unload that region during systole, and further is programmed to deliver anti-remodeling therapy (ART) by delivering neural stimulation to inhibit sympathetic nerve activity in conjunction with RCT. Other embodiments are provided herein.

Abstract: Systems and methods for correlating biometric trends with a related temporal event are disclosed. A preferred embodiment utilizes an implantable medical device comprising at least one sensor in electronic communication with a patient management system adapted to temporally analyze and correlate biometric data. Some embodiments of a system disclosed herein also can be configured as an Advanced Patient Management system that helps better monitor, predict and manage chronic diseases.

Abstract: An apparatus for reversing ventricular remodeling with electro-stimulatory therapy. A ventricle is paced by delivering one or more stimulatory pulses in a manner such that a stressed region of the myocardium is pre-excited relative to other regions in order to subject the stressed region to a lessened preload and afterload during systole. The unloading of the stressed myocardium over time effects reversal of undesirable ventricular remodeling.

Abstract: A cardiac electro-stimulatory device and method for operating same in which stimulation pulses are distributed among a plurality of electrodes fixed at different sites of the myocardium in order to reduce myocardial hypertrophy brought about by repeated pacing at a single site and/or increase myocardial contractility. In order to spatially and temporally distribute the stimulation, the pulses are delivered through a switchable pulse output configuration during a single cardiac cycle, with each configuration comprising one or more electrodes fixed to different sites in the myocardium.

Abstract: A sleep quality assessment approach involves collecting data based on detected physiological or non-physiological patient conditions. At least one of detecting patient conditions and collecting data is performed using an implantable device. Sleep quality may be evaluated using the collected data by an implantable or patient-external sleep quality processor. One approach to sleep quality evaluation involves computing one or more summary metrics based on occurrences of movement disorders or breathing disorders during sleep.