Systems and methods for epicardial pacing are provided. For example, this document provides epicardial pacing using a percutaneously delivered bifurcated pacing lead that has multiple electrodes that are directionally insulated to prevent extracardiac stimulation, including prevention of phrenic stimulation. In addition, the devices, systems, and methods provided can be used for ablation, defibrillation, and/or defibrillation in combination with pacing.

A delivery device for installing a medical device in a patient comprising a body portion having a proximal end and a distal end, the distal end having a chisel shaped tip, a receptacle disposed in the distal end of the body portion for receiving a medical device for implanting in the patient, a handle disposed at the proximal end of the body portion for facilitating advancement of the proximal end of the body portion into the patient.

A pericardial implantable cardioverter defibrillator (ICD) may be delivered to the heart through the chest wall using an ultrasound image guided catheter. The ICD may comprise a patch and wire leads which may be secured by a clam shell-like pad at a distal end and comprise a pig-tail shaped securing tail at the other end so that the ICD is firmly attached to the pericardium of a human heart. The ICD may be attached where most needed and serve as either a pacemaker or a defibrillator. In one embodiment, the ICD may emit radio frequency warning signals of heart failure sensed when pacemaker or defibrillator usage is rendered necessary.

A method and device for modulating the autonomic nervous system adjacent a pericardial space to treat cardiac arrhythmia includes a treatment source arranged to supply a treatment medium, a catheter having an end sized for insertion into the pericardial space, a medium delivery assembly having a distal end arranged to be positioned by the catheter into the pericardium, with the distal end of the delivery assembly comprising a delivery tip arranged to extend away from the distal end of the catheter into the pericardial space. A connector operatively couples the delivery tip of the medium delivery assembly to the treatment source, and the delivery tip of the medium delivery assembly including a plurality of delivery points for delivering the treatment medium at a plurality of treatment areas within the pericardial space. The device performs modulation or ablation of the autonomic nervous system at selected treatment areas within the pericardium.

A device comprising a three-dimensional polymeric element and an electronic element integrated with the polymeric element is disclosed. The electronic element is made up of one or more electrode(s) each individually connectable to a measuring device and/or a controller, and each independently having a thin electrically-isolating layer deposited thereon such that the electrode is exposed to an environment surrounding the electrode at one or more pre-determined locations over the electrode. The device can include cells and/or tissue and/or a therapeutically active agent incorporated within the polymeric material. Processes of fabricating the device, systems for operating the device and methods utilizing same are also disclosed.

The present disclosure provides methods and techniques associated with a planar transformer for an apparatus. The planar transformers include a substrate carrying electronic components and a continuous core that is formed by distributing the encapsulant material uniformly around the substrate unit to define a consistent cross-sectional area for the magnetic path. The electronic components include primary windings and secondary windings associated with the transformer. In some embodiments, the encapsulant material is molded to seals air gaps to the substrate unit.

A cardiac defibrillation system that includes a pulse generator to generate therapeutic electrical pulses and at least one lead inserted through an intercostal space in the region of a cardiac notch of the left lung of a patient, the lead having a distal end configured to transmit the therapeutic electrical pulses generated by the pulse generator to defibrillate the heart of the patient.

Systems, methods, and devices for delivering stimulating energy with a lead having a directional defibrillation electrode are disclosed. The lead includes a directional defibrillation electrode configured for implantation on or near the inner surface of a rib or the inner surface of the innermost intercostal muscle and having an electrically active portion configured to emanate stimulating energy from an exposed portion of the directional defibrillation electrode toward the pericardium and the heart. The lead also has an electrically insulating portion around at least part of the circumference of the lead. The electrically insulating portion is configured to insulate surrounding muscle and/or tissue from the stimulating energy when the lead is implanted in the patient.

A steerable catheter comprises a mobile tube and an intermediate tube, coaxial with each other, which extend from a proximal end to a distal end of the catheter and are telescopically mounted into each other with possibility of mutual rotation and axial translation. The mobile tube comprises a central lumen extending from the proximal end to the distal end. The intermediate tube comprises, along its whole length, a longitudinal notch radially offset in a direction of offset with respect to the axis of the steerable catheter and extending axially from the proximal end to the distal end. The longitudinal notch contains a cable adapted to undergo a traction exerted from the proximal end, the traction generating a bending of the steerable catheter directed towards the offset direction. The steerable catheter further comprises around the intermediate tube a sealed external sheath surrounding the intermediate tube over its periphery and covering the longitudinal notch over its length.

Methods and devices are provided for sensing cardiac events from electrodes located proximate to one or more atrial or ventricular sites, over a period of time that includes a detection period followed by an observation period. One or more processors declare a ventricular arrhythmia episode and a corresponding VT/VF therapy based on the cardiac events during at least the detection period. The processors delay delivery of the VT/VF therapy for a self-termination period within the observation period. The self-termination period represents a time period during which the ventricular arrhythmia episode may self-terminate. The processors analyze a stability characteristic of interest (COI) from the cardiac events sensed over at least a portion the observation period and determine an end point for the self-termination period, within the observation period, based on the stability COI. The VT/VF therapy is delivered when the VT/VF arrhythmia episode continues past the end point.