Abstract: An implantable cardiac rhythm/function management system integrates cardiac contractility modulation (CCM) and one or more other therapies, such as to preserve device safety, improve efficacy, enhance sensing and detection, or enhance therapy effectiveness and delivery. Examples of the one or more other therapies can include pacing, defibrillation/cardioversion, cardiac resynchronization therapy (CRT), or neurostimulation.

Abstract: Device for adaptive processing of an endocardial acceleration signal. The device continuously collects an endocardial acceleration EA signal and divides it into EA sub-signals, each over the duration of one cardiac cycle. The EA sub-signals are separated into the EA1 and EA2 components. A cross-correlation between the EA sub-signals of each component and a time calibration compared to a reference cycle, and a series of validation criteria is applied. The result is an average overall EA signal for a cycle. A change in the patients condition or an occurrence of a predetermined event in the patient is detected (24) and, as a result there is dynamic adaptation of at least one of said validation criteria and/or at least one of the pre-processing parameters for calculating the EA signal average.

Abstract: An implantable cardiac rhythm/function management system integrates cardiac contractility modulation (CCM) and one or more other therapies, such as to preserve device safety, improve efficacy, enhance sensing and detection, or enhance therapy effectiveness and delivery. Examples of the one or more other therapies can include pacing, defibrillation/cardioversion, cardiac resynchronization therapy (CRT), or neurostimulation.

Abstract: A device includes a signal generator module, a processing module, and a housing. The signal generator module is configured to deliver pacing pulses to an atrium. The processing module is configured to detect a ventricular activation event and determine a length of an interval between the ventricular activation event and a previous atrial event that preceded the ventricular activation event. The processing module is further configured to schedule a time at which to deliver a pacing pulse to the atrium based on the length of the interval and control the signal generator module to deliver the pacing pulse at the scheduled time. The housing is configured for implantation within the atrium. The housing encloses the stimulation generator and the processing module.

Abstract: An implantable cardiac rhythm/function management system integrates cardiac contractility modulation (CCM) and one or more other therapies, such as to preserve device safety, improve efficacy, enhance sensing and detection, or enhance therapy effectiveness and delivery. Examples of the one or more other therapies can include pacing, defibrillation/cardioversion, cardiac resynchronization therapy (CRT), or neurostimulation.

Abstract: The invention relates to methods and systems for determining phase-specific parameters of a physiological variable, and a related computer program and a related machine-readable storage medium, which are usable in particular to determine parameters of physiological variables that are subject to circadian variation. To this end, phase-specific parameters of a physiological variable X(t) are determined by calculating, at least for a portion of values x lying in a specifiable time period, a mean g(x|?) in each case of values X(t+?) for which X(t)=x applies for their predecessors, ? describing a time interval, and determining the phase-specific parameters by evaluating the mean g(x|?).

Abstract: An implantable medical device (IMD) includes a detector for detecting the presence of x-ray radiation, where the presence of x-ray radiation is detected in response to the strength of the x-ray radiation exceeding a first threshold. In one embodiment, the IMD includes a processor for adjusting a cardiac stimulation rate IMD in response to determining that the strength of the detected x-ray radiation exceeds a second threshold. The second pre-selected x-ray radiation threshold is greater than the first pre-selected x-ray radiation threshold. In another embodiment, the implantable device includes a detector for detecting the presence of any amount x-ray radiation and a processor for adjusting a stimulation rate provided by the IMD in response to detected x-ray radiation to reduce the chance of over-sampling artifacts or inappropriate therapy delivery.

Abstract: Various approaches to detecting arousals from sleep involve generating signals modulated by muscle tone, brainwave activity, and/or other nervous system activity associated with a patient's autonomic arousal response. Generating the signals and/or detecting autonomic arousals from sleep may be performed using an implantable device. Arousal information may be useful to identify sleep disorder events associated with arousals from sleep, for diagnostic purposes, and/or for therapy adjustment.

Abstract: A system for detecting myocardial ischemia includes an implantable device having one or more leads connected thereto, at least one electrode on a lead of the device, and a microprocessor in the implantable device. The electrode is configured to stimulate the heart. The at least one sensor is configured to measure a characteristic of blood in a coronary vessel. The microprocessor is programmed to: run a stress test on the heart by stimulating the heart with the electrode; record data obtained from the at least one sensor during the stress test; and determine whether there is myocardial ischemia based upon the recorded data.

Abstract: Systolic timing intervals are measured in response to delivering pacing energy to a pacing site of a patient's heart. An estimate of a patient's acute response to cardiac resynchronization therapy (CRT) for the pacing site is determined using the measured systolic timing intervals. The estimate is compared to a threshold. The threshold preferably distinguishes between acute responsiveness and non-responsiveness to CRT for a patient population. An indication of acute responsiveness to CRT for the pacing site may be produced in response to the comparison.

Abstract: Methods of cardiac rhythm analysis in an implantable cardiac stimulus device, and devices configured for such methods. In an illustrative embodiment, certain data relating to cardiac event rate or amplitude is modified following delivery of a cardiac stimulus. In another embodiment, cardiac rhythm analysis is performed using one of plural states, with the plural states using different criteria, such as a detection threshold, to detect cardiac events in a sensed signal. Following delivery of a cardiac stimulus, data is manipulated to force the analysis into one of the states, where stimulus is delivered, in the illustrative embodiment, only after a different state is invoked. Implantable devices incorporating operational circuitry for performing such methods are also included in other illustrative embodiments.

Abstract: Generally, the disclosure is directed one or more methods or systems of cardiac pacing employing a right ventricular electrode and a plurality of left ventricular electrodes. Pacing using the right ventricular electrode and a first one of the left ventricular electrodes and measuring activation times at other ones of the left ventricular electrodes. Pacing using the right ventricular electrode and a second one of the ventricular electrodes and measuring activation times at other ones of the left ventricular electrodes. Employing sums of the measured activation times to select one of the left ventricular electrodes for delivery of subsequent pacing pulses.

Abstract: A neurostimulation device includes an external neurostimulator worn by a patient using a bracing element that braces a portion of the patient's body. The external neurostimulator delivers neurostimulation to modulate a cardiovascular function of the patient. In one embodiment, the external stimulator delivers neurostimulation percutaneously to a stimulation target in the patient's body using at least one percutaneous stimulation electrode having a distal end lodged on or near the stimulation target.

Abstract: A system comprising implantable device, the implantable medical device including an intrinsic cardiac signal sensor, an impedance measurement circuit configured to apply a specified current to a transthoracic region of a subject and to sample a transthoracic voltage resulting from the specified current, and a processor coupled to the intrinsic cardiac signal sensor and the impedance measurement circuit. The processor is configured to initiate sampling of a transthoracic voltage signal in a specified time relation to a fiducial marker in a sensed intrinsic cardiac signal, wherein the sampling attenuates or removes variation with cardiac stroke volume from the transthoracic voltage signal, and determine lung respiration using the sampled transthoracic voltage signal.

Abstract: A method for managing bradycardia through vagus nerve stimulation is provided. An implantable neurostimulator configured to deliver electrical therapeutic stimulation in both afferent and efferent directions of a patient's cervical vagus nerve is provided. An operating mode is stored, which includes parametrically defining a maintenance dose of the electrical therapeutic stimulation tuned to restore cardiac autonomic balance through continuously-cycling, intermittent and periodic electrical pulses. The maintenance dose is delivered via a pulse generator through a pair of helical electrodes via an electrically coupled nerve stimulation therapy lead independent of cardiac cycle. The patient's physiology is monitored, and upon sensing a condition indicative of bradycardia, the delivery of the maintenance dose is suspended.

Abstract: A system level scheme for networking of implantable devices, electronic patch devices/sensors coupled to the body, and wearable sensors/devices with cellular telephone/mobile devices, peripheral devices and remote servers is described.

Abstract: Various aspects of the present subject matter provide an implantable medical device. In various embodiments, the device comprises a pulse generator, a first monitor and a controller. The pulse generator is adapted to generate a neural stimulation signal for a neural stimulation therapy. The neural stimulation signal has at least one adjustable parameter. The first monitor is adapted to detect an undesired effect. In some embodiments, the undesired effect is myocardial infarction. The controller is adapted to respond to the first monitor and automatically adjust the at least one adjustable parameter of the neural stimulation signal to avoid the undesired effect of the neural stimulation therapy. Other aspects are provided herein.

Abstract: An implantable device and associated method for delivering a multi-site pacing therapy includes electrodes for sensing cardiac signals and delivering cardiac pacing pulses. Electrodes positioned at first and second selected pacing sites are used to deliver pacing pulses to a first heart chamber using a bipole comprising the first electrode and the second electrode. A controller is configured to determine if anodal and cathodal capture can be achieved during pacing using the bipole. Responsive to anodal and cathodal capture being achieved, the controller selects a multi-site pacing configuration comprising the bipole for singly pacing the first and second pacing sites.

Abstract: A method for operating an implantable medical device to obtain substantially synchronized closure of the mitral and tricuspid valves based on sensed heart sounds includes sensing an acoustic energy; producing signals indicative of heart sounds of the heart of the patient over predetermined periods of a cardiac cycle during successive cardiac cycles; calculating a pulse width of such a signal; and iteratively controlling a delivery of the ventricular pacing pulses based on calculated pulse widths of successive heart sound signals to identify an RV interval or VV interval that causes a substantially synchronized closure of the mitral and tricuspid valve. A medical device for optimizing an RV interval or VV interval based on sensed heart sounds implements such a method and a computer readable medium encoded with instructions causes a computer to perform such a method.

Abstract: Provided is a cardiac-event processor (1) including a storing unit (11) that stores a time history of cardiac events, including heartbeats, in association with the presence/absence of nerve stimulation; a heart rate calculator (12) that calculates a heart rate for when each heartbeat is detected, on the basis of the time history of the cardiac events stored in the storing unit (11); and a frequency data generator (13) that separately adds up frequencies of the heart rates calculated by the heart rate calculator (12) for the cases with and without the nerve stimulation.

Abstract: The present disclosure describes methods, devices, and systems for generating, adjusting, and using cardiac waveform morphology templates. The morphology templates include target regions associated with features of cardiac waveforms. The target regions may be adjusted based on relationships between the target regions and features of detected cardiac waveforms associated with the target regions. The templates may be used to analyze cardiac waveforms to classify or monitor various waveform morphologies. Templates may be created or eliminated, for instance, based on a frequency of use. According to one approach, template creation involves providing target regions defined by one or more characteristics. The target regions are adjusted based on detected cardiac waveform features having similar characteristics. A template may be created using the target regions adjusted by this process.

Abstract: Exemplary methods are described for providing responsive vascular control with or without cardiac pacing. An implantable device with responsive vascular and cardiac controllers interprets physiological conditions and responds with an appropriate degree of vascular therapy applied as electrical pulses to a sympathetic nerve. In one implementation, an implantable device is programmed to deliver the vascular therapy in response to low blood pressure or orthostatic hypotension. The device may stimulate the greater splanchnic nerve, to effect therapeutic vasoconstriction. The vascular therapy is dynamically adjusted as the condition improves. In one implementation to benefit impaired physical mobility, vascular therapy comprises vasoconstriction and is timed to coincide with a recurring segment of the cardiac cycle. The vasoconstriction assists circulation and venous return in the lower limbs of inactive and bedridden individuals.

Abstract: A system in combination with a stimulator system and an electrophysiology recorder system in delivering a stimulator signal to a subject's heart is provided. The electrophysiology recorder system can be generally operable to acquire an electrocardiogram from the subject's heart. The system can include an electrical couple in electrical connection between the simulator system and the electrophysiology recorder. The electrical couple can be configured to communicate the stimulator signal without loading an impedance of the electrophysiology recorder system on the stimulator system.

Abstract: A cardiac rhythm management system selects one of multiple electrodes associated with a particular heart chamber based on a relative timing between detection of a depolarization fiducial point at the multiple electrodes, or based on a delay between detection of a depolarization fiducial point at the multiple electrodes and detection of a reference depolarization fiducial point at another electrode associated with the same or a different heart chamber. Subsequent contraction evoking stimulation therapy is delivered from the selected electrode.

Abstract: Approaches for selecting an electrode combination of multi-electrode pacing devices are described. Electrode combination parameters that support cardiac function consistent with a prescribed therapy are evaluated for each of a plurality of electrode combinations. Electrode combination parameters that do not support cardiac function are evaluated for each of the plurality of electrode combinations. An order is determined for the electrode combinations based on the parameter evaluations. An electrode combination is selected based on the order, and therapy is delivered using the selected electrode combination.

Abstract: Devices and methods of use for treating atrial arrhythmias. A single-pass lead includes a body portion having at least two electrodes configured to be positioned within or adjacent a right atrium of a heart of a patient, and a distal portion having at least two electrodes configured to be positioned within a blood vessel proximate the left atrium. The lead is configured to operated by an implantable therapy generator programmed to deliver a multi-stage therapy by activating various combinations of at least one electrode of the body portion of the lead and at least one electrode of the distal portion of the lead.

Abstract: Biventricular-triggered pacing is a pacing mode that can employ in cardiac resynchronization pacing at elevated heart rates. Described herein are methods and devices for implementing biventricular pacing in the context of multi-site left ventricular pacing.

Abstract: Methods, systems, and devices for signal analysis in an implanted cardiac monitoring and treatment device such as an implantable cardioverter defibrillator. In some examples, captured data including detected events is analyzed to identify likely overdetection of cardiac events. In some illustrative examples, when overdetection is identified, data may be modified to correct for overdetection, to reduce the impact of overdetection, or to ignore overdetected data. Several examples emphasize the use of morphology analysis using correlation to static templates and/or inter-event correlation analysis.

Abstract: A single-pass pacing lead capable of sensing and pacing both the atria and the ventricles is described. In some examples, the single-pass pacing lead is connected to a DDD pacemaker. In some examples, the single-pass pacing lead comprises four electrodes. In some examples, the lead includes three electrodes configured to be positioned in or near an atrium, e.g., the right atrium, and one electrode configured to be positioned in or near a ventricle, e.g., the left ventricle, when the lead is implanted. In other examples, the lead includes two electrodes configured to be positioned in each of the atrium and ventricle when the lead is implanted. In some examples, one of the electrodes, which is configured to be positioned proximate the coronary sinus ostium when the lead is implanted, comprises a helical element for fixation of the lead to tissue.

Abstract: Methods, systems, and apparatus for quantifying the quality of a fiducial time marker for a candidate heart beat, quantifying the quality of a candidate heart beat, or determining a time of beat sequence of the patient's heart. A fiducial time marker is obtained for a candidate heart beat. A quality index of said candidate heart beat is set to a first value. The candidate heart beat is tested with at least one beat validity test. At least a second value is added to said quality index of said candidate heart beat if said candidate heart beat passes said at least one beat validity test. The candidate heart beat is tested with at least a second heart beat validity test. At least a third value is added to said quality index of said candidate heart beat if said candidate heart beat passes said at least second heart beat validity test.

Abstract: Time delays between a feature of a signal indicative of electrical activity of a patient's heart and a feature of a plethysmograph signal indicative of changes in arterial blood volume are used to arrange the operation of an implantable device, such as a pacemaker. Shorter time delays between the feature of the signal indicative of electrical activity of a patient's heart and the feature of the plethysmograph signal indicative of changes in arterial blood volume are indicative of larger cardiac stroke volumes. The time delay can be used to select a pacing site or combination of pacing sites and/or to select a pacing interval set.

Abstract: Monitoring physiological parameter using an implantable physiological monitor in order to detect a condition predictive of a possible future pathological episode and collecting additional physiological data associated with the condition predictive of a possible future pathological episode. Monitoring another physiological parameter in order to detect a condition indicative of the beginning of a present pathological episode and collecting additional pathological data in response to the condition. Determining that the condition predictive of a future episode and the condition indicative of a present episode are associated and, in response thereto, storing all the collected physiological data.

Abstract: An implantable medical device that continuously measures the patient's intracardiac ventricular impedance. Extracts cardiac performance information based on the intracardiac impedance, including amplitude, timing and variability of cardiac contraction function. The device records and analysis trends in the performance information. The device identifies changes, which exceed the selected threshold limits. In the event of an incipient crisis, the device transmits an alert message.

Abstract: Techniques are disclosed for pacing site selection. In one example, a method includes using a sensing element such as an ultrasonic transducer, an optical pressure sensor, a MEMS pressure sensor, a SAW pressure sensor, an accelerometer, a gyroscope, or any other suitable sensing element to sense a measure related to a cardiac strain in a heart resulting from contraction and relaxation of myocardium during a cardiac cycle. Based on the sensed strain, an output may be provided for use by a user of the system to select a segment of the heart for lead placement.

Abstract: Techniques are provided for use with an implantable cardiac rhythm management (CRMD) system equipped to deliver neurostimulation to acupuncture sites within anterior regions of the neck, thorax or abdomen of the patient. Parameters associated with the health of the patient are detected, such as parameters indicative of arrhythmia, heart failure and hypertension.

Abstract: Intermittent delivery of ventricular pacing pulses synchronized to occur during an atrial diastole time period can be used to provide atrial stretch therapy and augment the production and release of atrial natriuretic hormone.

Abstract: An implantable medical device operates to promote intrinsic ventricular depolarization according to a pacing protocol. When a cardiac rate exceeds a predetermined threshold, the implantable medical device modifies the pacing protocol parameters to promote AV synchrony.

Abstract: Methods and/or devices are disclosed herein for monitoring cardiac impedance signal and delivering therapy to a patient's heart based upon the monitored cardiac impedance.

Abstract: A method and device for delivering therapy that includes an electrode to sense cardiac signals and to deliver a therapy, a therapy delivery module coupled to the electrode to deliver a therapy via the electrode in response to the sensed cardiac signals, a sensor emitting light and detecting emitted light scattered by a tissue volume adjacent the optical sensor to generate a corresponding detected light intensity output signal, a control module coupled to the sensor to control light emission of the sensor in response to delivering the therapy, and a controller coupled to the therapy delivery module and the sensor, the controller configured to determine tissue oxygenation measurements in response to the output signal, determine a tissue oxygenation trend in response to the tissue oxygenation measurements, and determine whether the delivered therapy restored cardiac hemodynamic function in response to the determined tissue oxygenation trend.

Abstract: A method for managing bradycardia through vagus nerve stimulation is provided. An implantable neurostimulator configured to deliver electrical therapeutic stimulation in both afferent and efferent directions of a patient's cervical vagus nerve is provided. An operating mode is stored, which includes parametrically defining a maintenance dose of the electrical therapeutic stimulation tuned to restore cardiac autonomic balance through continuously-cycling, intermittent and periodic electrical pulses. The maintenance dose is delivered via a pulse generator through a pair of helical electrodes via an electrically coupled nerve stimulation therapy lead independent of cardiac cycle. The patient's physiology is monitored, and upon sensing a condition indicative of bradycardia, the delivery of the maintenance dose is suspended.

Abstract: An implantable cardiac rhythm/function management system integrates cardiac contractility modulation (CCM) and one or more other therapies, such as to preserve device safety, improve efficacy, enhance sensing and detection, or enhance therapy effectiveness and delivery. Examples of the one or more other therapies can include pacing, defibrillation/cardioversion, cardiac resynchronization therapy (CRT), or neurostimulation.

Abstract: An implantable device and method for monitoring S1 heart sounds with a remotely located accelerometer. The device includes a transducer that converts heart sounds into an electrical signal. A control circuit is coupled to the transducer. The control circuit is configured to receive the electrical signal, identify an S1 heart sound, and to convert the S1 heart sound into electrical information. The control circuit also generates morphological data from the electrical information. The morphological data relates to a hemodynamic metric, such as left ventricular contractility. A housing may enclose the control circuit. The housing defines a volume coextensive with an outer surface of the housing. The transducer is in or on the volume defined by the housing.

Abstract: Various systems, methods, devices and arrangements are implemented for use in pacing of the heart. One implementation is directed to methods and systems for determining a pacing location in the right ventricle of a heart and near the His bundle. A pacing signal is delivered to the location in the right ventricle. The pacing signal produces a capture of a left ventricle. Properties of the capture are monitored. Results of the monitored capture are used to assess the effectiveness of the delivered pacing signal as a function of heart function. The heart function can be, for example, at least one of a QRS width, fractionation and a timing of electrical stimulation of a late activation site of a left ventricle relative to the QRS.

Abstract: Cardiac pacing methods for an implantable single chamber pacing system, establish an offset rate for pacing at a predetermined decrement from either a baseline rate (i.e. dictated by a rate response sensor), or an intrinsic rate. Pacing maintains the offset rate until x of y successive events are paced events, at which time the offset rate is switched to the baseline rate for pacing over a predetermined period of time. Following the period, if an intrinsic event is not immediately detected, within the interval of the offset rate, the rate is switched back to baseline for pacing over an increased period of time. Some methods establish a preference rate, between the offset and baseline rates, wherein an additional criterion, for switching from the offset rate to the baseline rate, is established with respect to the preference rate.

Abstract: A medical device system and method for detecting cardiac lead dislodgement measures intervals between sensed cardiac events for detecting an event interval pattern including at least one short event interval consecutively followed by a long event interval. Responsive to detecting the event interval pattern, a cardiac signal amplitude associated with a detected short event interval is measured. Dislodgement of the cardiac lead is detected in response to the measured amplitude.

Abstract: Systems and methods for determining pacing timing intervals based on the temporal relationship between the timing of local and non-local cardiac signal features are described. A device includes a plurality of implantable electrodes electrically coupled to the heart and configured to sense local and non-local cardiac signals. Sense circuitry coupled to first and second electrode pairs senses a local cardiac signal via a first electrode pair and a non-local cardiac signal via a second electrode pair. Detection circuitry is used to detect a feature of the local signal associated with activation of a heart chamber and to detect a feature of the non-local signal associated with activation of the heart chamber. A control processor times delivery of one or more pacing pulses based on a temporal relationship between timing of the local signal feature and timing of the non-local signal feature.

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: A method and device for delivering therapy that includes an electrode to sense cardiac signals and to deliver a therapy, a therapy delivery module coupled to the electrode to deliver a therapy via the electrode in response to the sensed cardiac signals, a sensor emitting light and detecting emitted light scattered by a tissue volume adjacent the sensor to generate a corresponding detected light intensity output signal, a control module coupled to the sensor to control light emission of the sensor in response to delivering the therapy; and a controller coupled to the therapy delivery module and the sensor, the controller configured to determine a tissue oxygenation measurement in response to the output signal, and determine whether the delivered therapy was successful in restoring cardiac hemodynamic function in response to the tissue oxygenation measurement.

Abstract: The current technology is relevant to a system having a programming device capable of communication with an implantable medical device, where the a programming device is configured to identify a patient condition comprising the patient's inability to exercise to a desired capacity, configured to notify a clinical user of the identified condition and configured to identify a therapy appropriate for the identified condition.

Abstract: Various configurations of systems that employ leadless electrodes to provide pacing therapy are provided. In one example, a system that provides multiple sites for pacing of myocardium of a heart includes wireless pacing electrodes that are implantable at sites proximate the myocardium using a percutaneous, transluminal, catheter delivery system. Each of the electrodes contains a source of electrical energy for pacing the myocardium and is adapted to receive electromagnetic energy from a source outside the myocardium. The system also includes a source adapted for placement outside the myocardium and that uses locally measured electrocardiograms to synchronize pacing of the heart by sending electromagnetic commands to the electrodes to pace the myocardium surrounding the electrodes. Also disclosed is various configurations of such systems, wireless electrode assemblies, and delivery catheters for delivering and implanting the electrode assemblies.