Abstract: A splint assembly includes an elongate body. An active fixation fastener is coupled substantially adjacent to a distal end of the elongate body. The splint assembly includes at least one flange coupled to the elongate body proximal the active fixation fastener. In one option, a stop of the at least one flange projects outside of an outer perimeter of the elongate body. In another option, the active fixation fastener is spaced from the at least one flange where the active fixation fastener and the at least one flange pull at least one heart chamber toward a substantially unexpanded shape when in an implanted condition within the heart an artery or a vein. In yet another option, the elongate body includes a predetermined curvature along at least a portion of the elongate body between the active fixation fastener and the at least one flange.

Abstract: An apparatus includes an implantable device, such as a chronically implantable device that has a device body. One or more chemical sensors are coupled with the device body. A drug eluting substance is disposed at a location including at least one of on, directly adjacent, or near the one or more chemical sensors, where the drug eluting substance prevents fibrotic growth on the one or more chemical sensors.

Abstract: Housings for implantable medical devices are configured so as to engage with surrounding tissues inside of a body and resist both rotation in place and movement through the body. Device housings include shapes, surface features, and/or standard surfaces and may include attached implements that engage the surrounding tissue. Shapes include elongated members, flared ends, and so forth. Surface features include pores, grooves, through-holes, and so forth. Attached implements include needles, barbs, tension springs, and so forth. Also provided are methods for engaging an implantable medical device with surrounding tissues.

Abstract: A method includes mounting an anchor member to a surface of a heart, the anchor member having a tension member coupled to the anchor member, advancing a lead body along the tension member, the lead body including a plurality of electrodes disposed along the lead body, identifying an MI region of the heart, positioning the plurality of electrodes at or near the MI region, affixing the tension member to the lead body to hold the electrodes in position, and delivering pulses through the plurality of electrodes to the heart.

Abstract: A lead for monitoring or stimulating cardiac activity is provided. The lead is adapted for implantation on or about the heart within the coronary vasculature and for connection to a signal generator. The lead body has one or more electrodes associated therewith. The lead is constructed and arranged so that when it is implanted, the electrodes are housed in the coronary vasculature and urged into intimate contact a vessel wall.

Abstract: A medical lead including a lead body extending from a first end portion to a second end portion and a coating disposed along a portion of the lead, wherein the coating includes at least one matrix polymer layer, at least one anti-inflammatory agent and at least one anti-proliferative agent.

Abstract: A system and device are provided which include a gene regulatory system controlling expression of one or more expression cassettes present in or released by the device, by emitting one or more stimulations. An expression cassette includes a regulatable transcription control element that is responsive to the emitted stimulations linked to an open reading frame of interest. The system optionally includes a sensor to sense a parameter indicative of a need, a telemetry module to receive an external command, or a programmable device, for regulating gene expression of the open reading frame.

Abstract: A system and device are provided which include a gene regulatory system controlling expression of one or more expression cassettes present in or released by the device, by emitting one or more stimulations. An expression cassette includes a regulatable transcription control element that is responsive to the emitted stimulations linked to an open reading frame of interest. The system optionally includes a sensor to sense a parameter indicative of a need, a telemetry module to receive an external command, or a programmable device, for regulating gene expression of the open reading frame.

Abstract: This document discusses, among other things a method including inserting an electrode into an umbilical vein, and advancing the electrode through the umbilical vein to a location near or in a heart. In an example, the electrode is inserted into an umbilical vein in utero. In another example, the electrode is inserted into an umbilical vein in a child soon after the child is born. In an example, the electrode is connected to a lead. In an example, a lead is inserted through a catheterized umbilicus.

Abstract: A cardiac pacing lead for electrically communicating with a human heart is attached to the heart using an adhesive. The lead includes a flexible, elongated lead body having a proximal end and a distal end, a pad having an interface surface coupled to the lead body at the distal end. An electrode is coupled to the pad. The lead further includes an adhesive for bonding the pad to the heart such that the electrode is electrically coupled to the heart. The adhesive is delivered to the interface surface after the lead has been inserted into a subject. In one embodiment, the lead system includes an anchor having an interface surface adapted for adhesive coupling to the heart. In this embodiment, the anchor is coupled to a tether and the lead includes a lumen adapted to accept the tether and to allow advancement of the lead over the tether.

Abstract: A technique for accessing a pericardial space of a heart includes attaching a grip to a pericardium with adhesive, grasping the grip, drawing the pericardium away from the heart, and perforating the pericardium. The grip may consist solely of an adhesive. In other embodiments, other structures for the grip are used, including anchors, suture loops, and gripping tubes.

Abstract: In one embodiment, the present invention provides a cardiac lead including a fixation member extending from a distal end of the lead. The fixation member includes a coated portion and an uncoated portion. The coating that forms the coated portion includes a biocompatible polymer material and a therapeutic agent. The coating may provide for the delivery of the therapeutic agent directly at the sight of fixation for an extended period of time.

Abstract: A spring fixation mechanism is adapted for fixing the distal end of an epicardial lead in a myocardium of the heart. The spring fixation mechanism is positioned at a distal end of the lead and includes a spring member and a stop. The spring member is formed about the lead and extends from a proximal end slidable relative to the lead to a distal end fixed to the lead. The stop is coupled to the proximal end of the spring member and is sized to be retained outside of an epicardium of the heart. The distal end of the lead, including the spring fixation mechanism, is inserted into the myocardium with a stylet and/or a pusher tube. The spring member is loaded and released, grasping tissue between adjacent coils of the spring member, fixing the lead within the myocardium.

Abstract: An epicardial patch includes an extracellular matrix (ECM) and a plurality of electrodes. The isolated ECM is configured for epicardial attachment over a myocardial region including an injured area to control post-injury remodeling of the myocardial region. The plurality of electrodes is configured for delivering electrical stimulation to enhance the effect of the isolated ECM in remodeling control by altering workload and stress on the myocardial region.

Abstract: A method includes sandblasting an electrode surface, applying a conductive oxide precursor solution to the electrode surface, and heating the electrode for at least 5 minutes at a temperature between 350 degrees C. and 550 degrees C. to convert the precursor solution into an oxide coating. One method includes applying a composite material including a conductive component and a non-conductive component to an electrode and curing the composite material to form a coating on the electrode. One method includes providing a metallic oxide coating on an electrode surface and applying a galvanostatic treatment to the electrode to increase the effective surface area of the metallic oxide coating.

Abstract: A splint assembly includes an elongate body. An active fixation fastener is coupled substantially adjacent to a distal end of the elongate body. The splint assembly includes at least one flange coupled to the elongate body proximal the active fixation fastener. In one option, a stop of the at least one flange projects outside of an outer perimeter of the elongate body. In another option, the active fixation fastener is spaced from the at least one flange where the active fixation fastener and the at least one flange pull at least one heart chamber toward a substantially unexpanded shape when in an implanted condition within the heart an artery or a vein. In yet another option, the elongate body includes a predetermined curvature along at least a portion of the elongate body between the active fixation fastener and the at least one flange.

Abstract: Various aspects of the present subject matter provide an implantable medical device. In various embodiments, the device comprises a pulse generator, a lead, a sensor, and a controller. The pulse generator generates a baroreflex stimulation signal as part of a baroreflex therapy. The lead is adapted to be electrically connected to the pulse generator and to be intravascularly fed into a heart. The lead includes an electrode to be positioned in or proximate to the heart to deliver the baroreflex signal to a baroreceptor region in or proximate to the heart. The sensor senses a physiological parameter regarding an efficacy of the baroreflex therapy and provides a signal indicative of the efficacy. The controller is connected to the pulse generator to control the baroreflex stimulation signal and to the sensor to receive the signal indicative of the efficacy of the baroreflex therapy. Other aspects are provided herein.

Abstract: An apparatus includes a flexible lead body extending from a proximal end to a distal end, the distal end having a biased portion having an outer diameter dimensioned to abut a wall of a pulmonary artery, an electrode coupled proximate the distal end, and an implantable pulse generator electrically coupled to the electrode. The implantable pulse generator is adapted to deliver a baroreflex stimulation signal to a baroreceptor in the pulmonary artery via the electrode.

Abstract: An apparatus includes a flexible lead body extending from a proximal end to a distal end, an expandable electrode coupled proximate the distal end, the expandable electrode having an expanded diameter dimensioned to abut a wall of a pulmonary artery, and an implantable pulse generator electrically coupled to the expandable electrode. The implantable pulse generator is adapted to deliver a baroreflex stimulation signal to a baroreceptor in the pulmonary artery via the electrode.

Abstract: The present invention is a myocardial lead attachment system for securing a lead within the myocardium. The attachment system includes an anchor configured to engage the heart, a tether coupled to the anchor and a lead body. The lead body has a proximal end, a distal end, a lumen for accepting the tether and a lock housing in the lumen. A lock structure is on the tether and mates with the lock housing and restrains motion of the lead with respect to the tether in either of a proximal or a distal direction.