Abstract: A medical device system and method for detecting dislodgement of a ventricular lead determines one or more characteristics of a cardiac signal received via the ventricular lead that are associated with dislodgement of the ventricular lead during atrial fibrillation, and detects dislodgement of the ventricular lead based on the determined characteristics. The medical device and system provides a lead dislodgment alert in response to detecting dislodgement. In some examples, an implantable medical device withholds delivery of a ventricular defibrillation therapy based on detecting dislodgement of the ventricular lead.

Abstract: A system for synchronizing application of treatment signals with a cardiac rhythm is provided. The system includes a memory that receives and stores a synchronization signal indicating that a predetermined phase such as R-wave of a cardiac rhythm of a patient has started. A synchronization module analyzes whether the stored synchronization signal is erroneous and if so, prevents a medical treatment device from applying a treatment energy signal such as an IRE pulse to a patient to take into account an irregular heart beat and noise in the synchronization signal in order to maximize safety of the patient.

Abstract: An implantable medical device (IMD) may include a communication module, a therapy control module, a firmware control module, and a service application. The communication module is configured to wirelessly communicate over an RF link with an external device. The therapy control module is configured to deliver therapy to the patient, and may include a reprogrammable therapy logic circuit configured to operate the therapy control module in a reprogrammable mode of operation, and base-therapy state machine (BTSM) logic circuit configured to operate the therapy control module in a base therapy mode of operation. The firmware control module may include CPU and a memory. The service application may be stored in the memory. The firmware control module is configured to launch the service application, and the BTSM logic circuit provides a base level of sensing and pacing therapy while the communications module in parallel maintains the RF link with the external device.

Abstract: On embodiment pertains to an apparatus including a control loop configured to receive an output voltage sense signal. The control loop includes a compensator; a PWM signal generator coupled to an output of the compensator; a reference circuit configured to receive a tracking signal, and which is configured to low bandwidth low pass filter the tracking signal when the tracking signal amplitude becomes substantially constant and representative of an output voltage that is substantially non-zero; and an error amplifier having a first input coupled to an output of the reference circuit, a second input configured to receive the output voltage sense signal, and an output coupled to the compensator.

Abstract: A nonaqueous electrolyte secondary battery attains both a high capacity and excellent low-temperature characteristics. A nonaqueous electrolyte secondary battery includes a positive electrode, a negative electrode, a separator, a nonaqueous electrolyte and a battery case accommodating the battery constituents, the positive electrode having a positive electrode mixture layer including a lithium transition metal oxide and a conductive auxiliary, the lithium transition metal oxide containing at least Ni. The percentage of Ni in the total moles of metal element(s) except lithium present in the oxide is not less than 88 mol %, the content of the conductive auxiliary being not less than 0.75 parts by mass and not more than 1.25 parts by mass, the ratio of the lithium transition metal oxide being not less than 25 parts by volume in the inside of the battery case.

Abstract: An implantable medical device is provided that comprises a pulse generator circuit that times delivery of ventricular pacing pulses based on a base intracardiac interval (ICI). A processor is provided that has memory storing program instructions and storing atrial and ventricular events over multiple cardiac cycles and that is responsive to execution of the program instructions. The processor adjusts the base ICI by an ICI adjustment, during one or more of the multiple cardiac cycles, to promote intrinsic heart activity. The processor further counts a number of the cardiac cycles in which the ICI adjustments occurred in conjunction with arrhythmias to identify an excessive adjustment count and modifies the ICI adjustment to utilize a new ICI adjustment based on the excessive adjustment count.

Abstract: An implantable leadless cardiac pacing device including a housing having a proximal end and a distal end, an electrode positioned proximate the distal end of the housing configured to be positioned adjacent cardiac tissue, and a tissue anchoring member extending from the distal end of the housing configured to secure the housing to cardiac tissue. The device further includes a tissue engagement verification feature configured to provide feedback upon engagement of the tissue anchoring member in cardiac tissue.

Abstract: One embodiment provides a system for cardiac stimulation optimization utilizing cardiac asynchrony and pulse pressure data. The system includes: an analysis circuitry to receive cardiac signals collected at two locations of a patient's heart during an application to the heart of stimulation in accordance with multiple (VV) delay intervals, calculate an asynchrony index for the VV delay intervals, and determine one of the VV intervals as optimal based on the asynchrony index for that VV interval; an implantable stimulation device to cycle through the VV intervals while applying the stimulation, and further configured to cycle through atrioventricular (AV) delay intervals while applying additional stimulation in accordance with the optimal VV delay interval; and an arterial pulse pressure sensor to measure arterial pulse pressure during the application of the additional stimulation, wherein the analysis circuitry determines one of the AV delay intervals as optimal based on the arterial pulse pressure measured.

Abstract: A medical device performs a method for detecting an atrial tachyarrhythmia by determining RR intervals between successive R-waves of a cardiac electrical signal and determining classification factors from the R-waves identified over a predetermined time period by determining at least a first classification factor correlated to variability of the RR intervals and a second classification factor indicating a presence of a ventricular tachyarrhythmia. The device classifies the cardiac electrical signal of the predetermined time period as unclassified, atrial tachyarrhythmia or non-atrial tachyarrhythmia by comparing the determined classification factors to classification criteria. The predetermined time period is classified as unclassified when the second classification factor indicates the presence of a ventricular tachyarrhythmia.

Abstract: In some embodiments, a cardiac monitoring system includes multiple sensors configured for implantation in a cardiovascular system of a user. Each sensor includes a sensing unit configured to be disposed in sensory communication with the location for measuring a biological parameter in the at least one heart chamber. The sensing unit is also configured to generate a sensory signal associated with the biological parameter. Each sensor also includes a wireless transceiver configured to receive the sensory signal from the sensing unit. The wireless transceiver is further configured to wirelessly transmit the sensory signal to an external processing device disposed outside a body of the user. The external processing device monitors, based on the sensory signal received from at least two sensors from the plurality of sensors, cardiac health associated with at least one of an implanted device or a surgery.

Abstract: A medical device and medical device system for controlling delivery of therapeutic stimulation pulses that includes a sensing device to sense a cardiac signal and emit a trigger signal in response to the sensed cardiac signal, a therapy delivery device to receive the trigger signal and deliver therapy to the patient in response to the emitted trigger signal, and a processor positioned within the sensing device, the processor configured to determine whether the sensed cardiac signal exceeds a possible P-wave threshold, compare a portion of the sensed cardiac signal to a P-wave template having a sensing window having a length less than a width of the P-wave, confirm an occurrence of a P-wave signal in response to the comparing, emit the trigger signal in response to the occurrence of a P-wave signal being confirmed, and inhibit delivery of the emitting signal in response to the occurrence of a P-wave signal not being confirmed.

Abstract: A medical device system is configured to sense a physiological signal by a first device and generate a control signal by the first device in response to the physiological signal. An optical transducer is controlled by the first device to emit an optical trigger signal in response to the control signal. A second device receives the optical trigger signal and delivers an automatic therapy to a patient in response to detecting the optical trigger signal.

Abstract: Systems and methods for monitoring and performing tissue modulation are disclosed. An example system may include an elongate shaft having a distal end region and a proximal end and having at least one modulation element and one sensing electrode disposed adjacent to the distal end region. The sensing electrode may be used to determine and monitor changes in tissue adjacent to the modulation element.

Abstract: Techniques for automatically identifying medical devices, e.g., implantable medical device, using wireless communications in order to communicate with the medical devices are described. For instance, a programming system securely discovers a set of medical devices which have the capacity to communicate using wireless communication links. The programming system may then apply one or more search heuristics to identify a set of discovered medical devices that are likely to be a medical device with which a user desires to interact. When the user selects the desired one of the identified medical devices, the programming system launches a device interaction application associated with the desired medical device. The user may use the device interaction application to interact with the desired medical device.

Abstract: Systems, methods, and interfaces are described herein for assisting a user in noninvasive evaluation of patients for cardiac therapy and noninvasive evaluation of cardiac therapy being delivered. The systems, methods, and interfaces may provide graphical representations of cardiac electrical activation times about one or more portions of human anatomy and one or more cardiac health metrics.

Abstract: Systems, methods, and interfaces are described herein for assisting a user in noninvasive evaluation of patients for cardiac therapy and noninvasive evaluation of cardiac therapy being delivered. The systems, methods, and interfaces may provide graphical representations of cardiac electrical activation times about one or more portions of human anatomy and one or more cardiac health metrics.

Abstract: A method utilizing computer processing for detecting, within a cardiac cycle, the earliest onset of global, Q-onset, ventricular depolarization in the presence of an operating pacemaker. The method, in general terms, features (a) gathering a plurality of ECG-obtained QRS heart-cycles waveforms, (b) identifying and categorizing of evidences and specific timings therein of intrinsic Q-onset and pacemaker spike events, (c) looking in a single, selected QRS waveform, between specific, defined first and second time marks, for the most significant slope change appearing in that waveform, and (d) designating to be the correct Q-onset that event which immediately precedes that slope change.

Abstract: An implementation provides a system that includes: a control module including a first antenna, the control module configured to generate a first radio frequency (RF) signal and transmit the first RF signal using the first antenna; an implantable lead module including a second antenna and at least one electrode configured to stimulate excitable tissue of a subject; and a relay module configured to receive the first RF signal; generate a second RF signal based on the first RF signal, the second RF signal encoding a stimulus waveform to be applied by the at least one electrodes of the implantable lead module to stimulate the excitable tissue of the subject; and transmit the second RF signal to the implantable lead module.

Abstract: Electrode structures for transvascular nerve stimulation combine electrodes with an electrically-insulating backing layer. The backing layer increases the electrical impedance of electrical paths through blood in a lumen of a blood vessel and consequently increases the flow of electrical current through surrounding tissues. The electrode structures may be applied to stimulate nerves such as the phrenic, vagus, trigeminal, obturator or other nerves.

Abstract: A method for analysis of cardiac rhythms, based on calculations of entropy and moments of interbeat intervals. An optimal determination of segments of data is provided that demonstrate statistical homogeneity, specifically with regard to moments and entropy. The invention also involves calculating moments and entropy on each segment with the goal of diagnosis of cardiac rhythm. More specifically, an absolute entropy measurement is calculated and provided as a continuous variable, providing dynamical information of fundamental importance in diagnosis and analysis. Through the present invention, standard histograms, thresholds, and categories can be avoided.

Abstract: An implantable medical device (IMD) configures one or more operating parameters of the IMD based on a type of source of a disruptive energy field to which the IMD is exposed. The disruptive energy field may, in one example, include magnetic and/or radio frequency (RF) fields generated by an MRI scanner. In one aspect, the IMD may distinguish between different types of MRI scanners and select an exposure operating mode tailored to reduce the effects of the particular type of MRI scanner. In another aspect, the IMD may adjust one or more operating parameters that will be used when the IMD returns to a normal operating mode after exposure to the MRI scanner based on the type of MRI scanner to which the IMD is exposed.

Abstract: Methods and/or devices may be configured to track effectiveness of pacing therapy by monitoring activation times over time, e.g., between pacing stimulus and electrical activity resulting from the pacing stimulus. Generally, the methods and/or devices may determine whether the delivered pacing therapy was effective based on the measured activation times.

Abstract: The present application discloses systems and methods for distributed processing of electrophysiological signals. The system may include a processor, a remote device, and an implant comprising an array of electrodes. The method may comprise the processor receiving an electrophysiological signal request from the remote device that specifies at least one electrode at the implant from which to receive an electrophysiological signal, transmitting to the implant instructions to apply a plurality of stimuli via the specified at least one electrode and, for individual stimuli in the plurality of stimuli, recording an electrophysiological signal component resulting from the stimulus. The method may also comprise the processor combining the recorded individual electrophysiological signal components to produce the electrophysiological signal and transmitting the electrophysiological signal to the remote device for further processing.

Abstract: Methods and/or devices may be configured to monitor ventricular activation times and modify an atrioventricular delay (AV delay) based on the monitored ventricular activation times. Further, the methods and/or devices may determine whether the AV delay should be modified based on the measured activation times before modifying the AV delay.

Abstract: A medical device for stimulating the heart using biventricular stimulation. The device includes a sensor for detecting an endocardial acceleration parameter and a processing circuit configured to receive the endocardial acceleration parameter. The device further includes stimulation electronics coupled to the processing circuit. The processing circuit is configured to use the EA parameter to evaluate the biventricular stimulation. The evaluation includes comparing the value of the EA parameter in biventricular mode to the value of the EA parameter in left only mode or right only mode, and using the comparison and an assessment of the variability of the EA parameter as a function of the AVD in the left or right mode to distinguish between cases comprising: (a) normal operation, (b) a loss of RV or LV capture, (c) possible anodal stimulation. The processing circuit is further configured to conduct at least one update to operational parameters of the device based on the determined case.

Abstract: An implantable rate responsive pacemaker includes a sensor module configured to produce an activity signal correlated to a metabolic demand of a patient and a posture signal correlated to patient posture. The pacemaker further includes a pulse generator configured to generate and deliver pacing pulses to a patient's heart via a pair of electrodes coupled to the pacemaker. A control module is coupled to the pulse generator and the sensor module and is configured to determine a sensor indicated pacing rate from the activity signal, compare the posture signal to verification criteria for confirming an exercising posture of the patient, and withhold an adjustment of a pacing rate to the sensor indicated pacing rate responsive to the verification criteria not being met.

Abstract: An implantable medical device (IMD) determines an effect of the disruptive energy field and adjusts one or more operating parameters of the IMD based on at least the determined effect. In some instances, the IMD may determine an actual effect of the disruptive energy field, such as a temperature change, impedance change, pacing or sensing threshold change, MRI-induced interference one pacing or sensing, or other actual effect. In other instances, the IMD may determine a predicted effect of the disruptive energy field based on one or more characteristics of the exposure. In any case, the IMD adjusts one or more parameters based on at least the determined effect.

Abstract: A medical electrical lead having an elongated lead body and a fixation helix extending along a generally helical axis, mounted around the outer circumference of the lead body. The fixation helix has a free end spaced from and extending from the lead body for less than the circumference of the lead body. The lead body includes an additional component which provides a rotation stop extending from the outer circumference of the lead body and provides stop surface generally perpendicular to the axis of the helix.

Abstract: The invention provides a method of monitoring a subject's neurological condition. In some embodiments, the method includes the steps of analyzing a physiological signal (such as an EEG) from a subject to determine if the subject is in a contra-ictal condition; and if the subject is in a contra-ictal condition, providing an indication (e.g., to the subject and/or to a caregiver) that the subject is in the contra-ictal condition, such as by activating a green light or other visible output. In some embodiments, if the subject is in a pro-ictal condition, the method includes the step of providing an indication (such as a red light) that the subject is in the pro-ictal condition. The invention also provides neurological system monitors.

Abstract: Systems and methods for monitoring and performing tissue modulation are disclosed. An example system may include an elongate shaft having a distal end region and a proximal end and having at least one modulation element and one sensing electrode disposed adjacent to the distal end region. The sensing electrode may be used to determine and monitor changes in tissue adjacent to the modulation element.

Abstract: An electronic device and a method for determining a shield state in an electronic device are provided. The method includes at a detecting pad, detecting an electrical signal corresponding to a contact state of a shielding that contacts a ground or the detecting pad, and determining a shield state by the shielding based on the detected electrical signal.

Abstract: Systems and methods can be used to provide an indication of heart function, such as an indication of mechanical function or hemodynamics of the heart, based on electrical data. For example, a method for assessing a function of the heart can include determining a time-based electrical characteristic for a plurality of points distributed across a spatial region of the heart. The plurality of points can be grouped into at least two subsets of points based on at least one of a spatial location for the plurality of points or the time-based electrical characteristics for the plurality of points. An indication of synchrony for the heart can be quantified based on relative analysis of the determined time-based electrical characteristic for each of the at least two subsets of points.

Abstract: Systems and methods are provided for delivering neurostimulation therapies to patients for treating chronic heart failure. A neural fulcrum zone is identified and ongoing neurostimulation therapy is delivered within the neural fulcrum zone. The implanted stimulation device includes a physiological sensor for monitoring the patient's response to the neurostimulation therapy on an ambulatory basis over extended periods of time and a control system for adjusting stimulation parameters to maintain stimulation in the neural fulcrum zone based on detected changes in the physiological response to stimulation.

Abstract: An implantable medical device (IMD) may be configured into a sensing only mode in which the IMD does not delivery therapy. For example, the IMD may be configured to operate in a sensing only mode to reduce the undesirable effects that may be caused by external fields, such as those generated by an MRI device. However, there may be instances, such as a change in the patient's condition, in which it may be desirable to transition from the sensing only mode to a pacing mode to provide therapy. In accordance with the techniques described herein, the IMD monitors signals on one or more leads coupled to the medical device while operating in the sensing only mode and transitions to a pacing mode in response to not detecting a minimum number of signals on the one or more leads.

Abstract: Techniques and systems for monitoring cardiac arrhythmias and delivering electrical stimulation therapy using a subcutaneous device (e.g. subcutaneous implantable (SD)) and a leadless pacing device (LPD) are described. In one or more embodiments, a computer-implemented method includes sensing a first electrical signal from a heart of a patient through a SD. The first signal is stored into memory and serves as a baseline rhythm for a patient. Subsequently, a second signal is sensed from the heart through the SD. A cardiac condition can be detected within the sensed second electrical signal through the SD. A determination is made as to whether cardiac resynchronization therapy (CRT) is appropriate to treat the detected cardiac condition. A determination can then be made as to the timing of pacing pulse delivery to cardiac tissue through a leadless pacing device (LPD). The LPD receives communication from the SD requesting the LPD to deliver CRT to the heart.

Abstract: An implantable pacemaker is configured to sense a cardiac electrical signal received by a pair of electrodes coupled to the pacemaker, start a pacing escape interval to control a time that a pacing pulse is delivered in a heart chamber, and detecting if the sensed cardiac electrical signal is a crosstalk event that is an electrical pulse delivered to the patient by a different device than the implantable pacemaker. The implantable pacemaker withholds restarting the pacing escape interval in response to sensing the cardiac electrical signal based on detecting the sensed cardiac electrical signal as the crosstalk event.

Abstract: Apparatus for facilitating ablation of nerve tissue of a subject is provided, comprising (1) an ablation unit, configured to be percutaneously advanced to a site adjacent to a first portion of the nerve tissue; (2) at least one electrode unit, coupled to the ablation unit, and configured to be percutaneously advanced to a site adjacent to a second portion of the nerve tissue, and to initiate unidirectional action potentials in the nerve tissue, such that the unidirectional action potentials propagate toward the first portion of the nerve tissue; and (3) a control unit, configured: (a) to drive the ablation unit to ablate, at least in part, the first portion of the nerve tissue of the subject, and (b) to drive the at least one electrode unit to initiate the unidirectional action potentials by applying an excitatory current to the second portion of the nerve tissue.

Abstract: Bootstrap circuit includes: a first transistor of first conductivity type having a first main electrode, a second main electrode and a control electrode connected to a first power supply terminal, a first node, and a second node, respectively; a second transistor of the first conductivity type having a first main electrode, a second main electrode, and a control electrode connected to the first power supply terminal, the second node and the first node, respectively; a first capacitor having a first end connected to the first node and a second end where a first boost pulse is applied; a second capacitor having a first end connected to the second node and a second end where a second boost pulse having opposite polarity to the first boost pulse is applied; and a boost output terminal which outputs boost voltage higher than first power supply voltage supplied to the first power supply terminal.

Abstract: Apparatus and methods are described, including apparatus for pacing a heart of a subject. The apparatus includes an implantable pulse generator (IPG) and a coiled lead connected to the IPG. The coiled lead includes a smaller-diameter coiled portion, a lumen of which having a first coil-lumen-diameter, and a larger-diameter coiled portion electrically in series with the smaller-diameter coiled portion, a lumen of the larger-diameter coiled portion having a second coil-lumen-diameter that is larger than the first coil-lumen-diameter. A perpendicular distance from a central longitudinal axis of the smaller-diameter coiled portion to the lumen of the larger-diameter coiled portion is greater than an outer radius of the smaller-diameter coiled portion, when the central longitudinal axis of the smaller-diameter coiled portion is parallel to a central longitudinal axis of the larger-diameter coiled portion. Other applications are also described.

Abstract: Methods and/or devices may be configured to monitor ventricular activation times and modify an atrioventricular delay (AV delay) based on the monitored ventricular activation times. Further, the methods and/or devices may determine whether the AV delay should be modified based on the measured activation times before modifying the AV delay.

Abstract: A system and method for identifying whether local tissue latency is present. The system and method comprises an implanted lead having a first electrode for cardiac pacing and sensing. A sensing module for sensing heart activity with the first electrode to produce an electrogram (EGM) waveform. A processor is configured to receive the EGM waveform and extract two or more features from the EGM waveform representative of heart activity in response to monoventricular or biventricular pacing stimulus at the electrode and identify local tissue latency at a site of the first electrode based upon at least two of the extracted features indicating local tissue latency.

Abstract: Designs and methods of construction for an implantable medical device employ an internal support structure. The single-piece support structure holds various electronic components such as a communication coil and a circuit board, and further is affixed to a battery, thus providing a subassembly that is mechanically robust. The support structure further provides electrical isolation between these and other components. A method of construction allows for the subassembly to be adhered to a case of the implantable medical device at the battery, and possibly also at the support structure. The battery includes an insulating cover having holes. An adhesive is used consistent with the location of the holes to affix the battery to the case without electrically shorting the battery to the case.

Abstract: A method and apparatus for treatment of hypertension and heart failure by increasing secretion of endogenous atrial hormones by pacing of the heart. Pacing is done during the ventricular refractory period resulting in premature atrial contraction that does not result in ventricular contraction. Pacing results in the atrial wall stress, peripheral vasodilation, ANP secretion. Concomitant reduction of the heart rate is monitored and controlled as needed with backup pacing.

Abstract: A wireless cardiac stimulation device is disclosed comprising a controller-transmitter, a receiver, and a stimulating electrode, wherein the stimulating electrode and the receiver are separately implantable at cardiac tissue locations of the heart and are connected by a local lead. Having separately implantable receiver and stimulating electrodes improves the efficiency of ultrasound mediated wireless stimulation by allowing the receiver to be placed optimally for reception efficiency, thereby resulting in longer battery life, and by allowing the stimulating electrode to be placed optimally for stimulus delivery. Another advantage is a reduced risk of embolization, since the receiver and stimulating electrode ensemble is attached at two locations of the heart wall, with the connecting local leads serving as a safety tether should either the receiver or the stimulating electrode become dislodged.

Abstract: Systems and methods are provided for delivering neurostimulation therapies to patients for treating chronic heart failure. A neural fulcrum zone is identified and ongoing neurostimulation therapy is delivered within the neural fulcrum zone. This neural fulcrum zone may be identified by monitoring a patient's response to incrementally increased intensity settings at a first frequency. If the incremental intensity increases do not result in the identification of the neural fulcrum zone, the frequency may be changed to provide finer resolution identification of the neural fulcrum zone.

Abstract: Embodiments include an implantable electronic device with at least one electromagnetic field detection unit and at least one antenna, wherein the at least one electromagnetic field detection unit is connected to the at least one antenna. The at least one electromagnetic field detection unit responds to electromagnetic fields that occur or are present in an environment surrounding a patient outside an environment of an MRI device and electromagnetic fields that are shielded in the environment of the MRI device. The at least one electromagnetic field detection unit indicates an absence of the electromagnetic fields that typically occur in the environment surrounding a patient outside an MRI device and that are shielded in the environment of an MRI device.

Abstract: A method and apparatus for treatment of heart failure by increasing secretion of endogenous naturetic hormones ANP and BNP such as by stimulation of the heart atria. Heart pacing is done at an atrial contraction rate that is increased and can be higher than the ventricular contraction rate. Pacing may include mechanical distension of the right atrial appendage. An implantable device is used to periodically cyclically stretch the walls of the appendage with an implanted balloon.

Abstract: A medical device is configured to deliver a shock to a patient's heart via electrodes coupled to the medical device and set an escape interval timer to start running an escape interval after delivering the electrical shock. A sensing module of the medical device is configured to sense a cardiac event in response to a cardiac electrical signal received by the medical device crossing a sensing threshold. The medical device determines if the cardiac event meets reset criteria and allows the escape interval timer to continue running the escape interval if the cardiac event does not meet the reset criteria.

Abstract: A method for mapping an anatomical structure includes sensing activation signals of intrinsic physiological activity with a plurality of electrodes disposed in or near the anatomical structure, identifying at least one of the electrodes not in direct contact with the anatomical structure, and adjusting the activation signals sensed by each of the plurality of electrodes based on the activation signals sensed by the identified at least one of the electrodes not in direct contact with the anatomical structure.

Abstract: The present invention provides a switched-mode power converter with regulation demand pulses sent across a galvanic isolation barrier.