Abstract: Certain aspects of the disclosure pertain to methods and apparatus for providing positive fixation of medical components to a portion of incised pericardial tissue. Accordingly, a resilient member protrudes through an incision in the pericardium and produces a positive biasing force to adjacent pericardial tissue against a side surface of an attached body structure. The resilient member can optionally be compressed during implantation and then relaxed to thereafter provide the positive biasing force. Diverse medical components can thus be safely and reliably chronically deployed into the pericardial space, including without limitation, cardiac sensing/pacing, defibrillation and/or cardioversion electrodes, mechanical and/or metabolic sensors and the like. More than one body structure can be linked to a single medical electrical lead and the medical components can couple within and/or upon a portion of the body structure, the resilient member, and the lead in myriad configurations.

Abstract: An implantable medical device that includes an elongated body having a proximal end and a distal end, a helical fixation member extending from the distal end of the elongated body, the helical fixation member including a distal tip for affixing the distal end of the elongated body at an implant site, and a tracking member extending from the distal end of the elongated body, through the helical fixation member and outward from the distal tip of the helical fixation member for tracking along an implant pathway during implantation of the implantable medical device.

Abstract: A lead delivery apparatus includes an electrically conductive lead for an implantable medical device, a delivery shaft for delivering the lead to a target site, a fixator and a pulley structure. A flexible member is coupled to the delivery shaft and the lead and engages the pulley structure such that pulling a first portion of the flexible member moves the lead to the target site.

Abstract: In an implantable medical device that provides atrial and ventricular pacing in an atrial-based pacing mode, longer periods of time are permitted for intrinsic AV conduction to occur. By monitoring the patient's AV delay under these circumstances, useful information is obtained that can be correlated to other patient conditions or symptoms.

Abstract: A system, comprising a sterilizable package; an implantable medical device placed inside the sterilizable package; and an electrical interface electrically coupled to the implantable medical device and extending from inside the sterilizable package to outside the sterilizable package. In various embodiments, the interface may include package contacts electrically coupled to electrode terminals on the implantable medical device, patient terminals and conductors extending between the package contacts and the patient terminals.

Abstract: A medical electrical lead includes a canted lead body distal portion extending from an approximately straight lead body proximal portion; the canted distal portion includes an approximately straight segment and a hump-like segment extending from a first end, in proximity to the approximately straight segment, to a second end. The lead further includes a first electrode coupled to the approximately straight segment of the distal portion and a second electrode coupled to the distal portion in proximity to a second end of the hump-like segment.

Abstract: An implantable medical lead configured for active fixation in the vasculature of a patient includes an elongated lead body having a central lumen and a distal tip. Disposed within the central lumen are a fixation helix and an elongated member, such as a lead coil, coupled to the fixation helix. The elongated member is adapted to rotate the fixation helix, thereby causing it to advance or retract within the central lumen of the lead body. The lead body includes a window along a portion of its length through which the fixation helix may be affixed to a blood vessel of the patient's vasculature.

Abstract: A system, comprising a sterilizable package; an implantable medical device placed inside the sterilizable package; and an electrical interface electrically coupled to the implantable medical device and extending from inside the sterilizable package to outside the sterilizable package. In various embodiments, the interface may include package contacts electrically coupled to electrode terminals on the implantable medical device, patient terminals and conductors extending between the package contacts and the patient terminals.

Abstract: A lead implant system includes a lead coupling device, which is configured to couple a lead during an implant procedure, in communication with a medical device and an implantable medical device, which is contained within a package that includes an electrical interface for electrical coupling with an electrical contact of the implantable medical device. The electrical interface facilitates coupling of the packaged medical device to an electrical contact of another medical device, which is located outside the package. If the electrical contact of the packaged device is mounted within a bore of the device, then the connector structure allows for passage of a sterilizing gas into the connector bore, and past the connector contact, within the bore.

Abstract: This document provides a simple and automatic method for determining an optimal AV interval and/or range of AV intervals for, in an exemplary embodiment, LV-only pacing. Such a method provides significant advantages for patients while reducing burdens related to post-implant follow-up by clinicians in that it greatly reduces the need for doing echocardiographic-based AV interval optimization procedures as well as providing a way to dynamically optimize AV intervals as the patient moves about their activities of daily living (ADL).

Abstract: A system and method of determining hemodynamic parameters uses sensed ventricular blood pressure during a portion of ventricular pressure waveform following peak pressure. An estimated arterial diastolic pressure is based upon an amplitude of the sensed ventricular pressure corresponding to a time at which a first derivative of ventricular pressure as a function of time is at a minimum (dP/dtmin). Fill parameters such as isovolumetric relaxation constant, ventricular suction pressure, atrial kick pressure, and transvalve pressure gradient are derived from measured pressures representing minimum ventricular pressure, ventricular diastolic pressure, and diastasis pressure.

Abstract: An implantable medical device provides ventricular pacing capabilities and optimizes AV intervals for multiple purposes. In general, intrinsic conduction is promoted by determining when electromechanical systole (EMS) ends and setting an AV interval accordingly. EMS is determined utilizing various data including QT interval, sensor input, and algorithmic calculations.

Abstract: A method of classifying arrhythmias using scatter plot analysis to define a measure of variability of a cardiac rhythm parameter such as for example, without limitation, R-R interval, A-A interval, and the slope of a portion of a cardiac signal, is disclosed. The variability measurement is derived from a scatter plot of a cardiac rhythm parameter, employing a region counting technique that quantifies the variability of the cardiac rhythm parameter while minimizing the computational complexity. The method may be employed by an implantable medical device or system, such as an implantable pacemaker or cardioverter defibrillator, or by an external device or system, such as a programmer or computer. The variability measurement may be correlated with other device or system information to differentiate between atrial flutter and atrial fibrillation, for example. The variability information may also be used by the device or system to select an appropriate therapy for a patient.

Abstract: An improved system for measuring changes in blood flow, particularly in the context of an automatic arrhythmia treatment device. The system includes a heater, exposable to a bloodstream, a driver providing power to the heater, a temperature sensor, isolated from the blood stream and thermally coupled to the temperature of the heater and a measurement circuit coupled to the temperature sensor, providing signals indicative of blood flow. The system may include an intravascular lead having a lead body wherein the heater is mounted to the lead body so as to dissipate its generated heat into the blood. The heater and temperature sensor may be thermally insulated from the lead body and the heater and the temperature sensor may be on substantially a single isotherm during operation.

Abstract: A method and system for detecting T-wave alternans for use in an implanted medical device uses wave transformation of QT intervals to obtain a reliable measure of TWA. In one embodiment, an array provides alternating sign multiplication factors which are applied respectively to n consecutive QT values. Each successive QT value is high pass filtered and moved sequentially through a queue so that each cycle each of the n QT values is multiplied by one of the factors; the products are summed and made absolute to provide an alternans match value. The alternans match is compared with a noise threshold signal, and alternans is declared when the match exceeds the threshold by a predetermined amount. The array is programmable and can be varied, providing a high degree of flexibility to optimize the test for the patient.

Abstract: This disclosure relates to fault tolerant instantiations of a cardiac therapy delivery device such as an implantable cardiac stimulator (e.g., an implantable pulse generator, IPG, and/or an implantable cardioverter-defibrillator, ICD) coupled to an implantable physiologic sensor (IPS). According to the disclosure delivery of cardiac pacing and/or cardioversion-defibrillator therapy delivery can cause errors in output signals from an IPS. Resolution of such errors involves selectively energizing (or disconnecting the output signal from) the IPS during pacing and/or defibrillation therapy delivery. Programmable signal “blanking” in lieu of or in addition to the foregoing also improves the integrity of the output signal (i.e., continuously energize the IPS and ignore parts of the output signal). An ICD having a transient weakness in an insulated conductor used for the IPS signal can likewise have the IPS de-energized and/or blank the IPS output signal during high voltage therapy delivery.

Abstract: A medical device and method for determining baroreflex sensitivity (BRS) based on one or more respiration cycles. The BRS determination may be performed continuously based on measurements of heart rate, blood pressure, and respiration cycles.

Abstract: An interface adapter for an implantable medical electrical lead facilitates temporary electrical connection between an external medical device and a connector terminal of the lead. A sidewall of the adapter surrounds a receptacle of the adapter and includes a contact opening formed therethrough, to the receptacle; the sidewall further includes at least one external feature that holds a connector member of the external medical device in a tilted orientation. The tilted orientation biases a contact surface of the connector member through the contact opening and into electrical contact with an exposed connector contact of the lead connector terminal, when the terminal is inserted within the receptacle of the adapter.

Abstract: A system and method for monitoring left ventricular (LV) lateral wall motion and for optimizing cardiac pacing intervals based on left ventricular lateral wall motion is provided. The system includes an implantable or external cardiac stimulation device in association with a set of leads including a left ventricular epicardial or coronary sinus lead equipped with a motion sensor electromechanically coupled to the lateral wall of the left ventricle. The device receives and processes wall motion sensor signals to determine a signal characteristic indicative of systolic LV lateral wall motion or acceleration. An automatic pacing interval optimization method evaluates the LV lateral wall motion during varying pacing interval settings, including atrial-ventricular intervals and inter-ventricular intervals and selects the pacing interval setting(s) that correspond to LV lateral wall motion associated with improved cardiac synchrony and hemodynamic performance.

Abstract: A medical device and method for determining a parameter for delivery of a predetermined pacing therapy that includes a plurality of electrodes to deliver a pacing therapy, including the predetermined pacing therapy, and a control unit to control the timing of the delivery of the pacing therapy, including the predetermined pacing therapy, by the electrodes. A processor generates a first template in response to the pacing therapy being delivered to only one of a right ventricle and a left ventricle, and a second template in response to the pacing therapy being delivered to only the other of the right ventricle and the left ventricle, and determines the parameter in response to a comparing of subsequently delivered pacing therapy to the first template and the second template.