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 expandable electrode includes a plurality of electrode zones. The implantable pulse generator is adapted to deliver a baroreflex stimulation signal to a baroreceptor in the pulmonary artery via the electrode.

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 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 medical electrical lead for transvascularly stimulating a nerve, muscle or other tissue from an adjacent vessel is described. The lead includes a bifurcated distal portion including a first elongate member forming a first spiral and a second elongate member forming a second spiral. The spirals can be in parallel or serial alignment with one another.

Abstract: Cardiac monitoring and/or stimulation methods and systems provide monitoring, defibrillation and/or pacing therapies. A signal processor receives a plurality of composite signals associated with a plurality of sources, separates a signal using a source separation algorithm, and identifies a cardiac signal using a selected vector. The signal processor may iteratively separate signals from the plurality of composite signals until the cardiac signal is identified. The selected vector may be updated if desired or necessary. A method of signal separation involves detecting a plurality of composite signals at a plurality of locations, separating a signal using source separation, and selecting a vector that provides a cardiac signal. The separation may include a principal component analysis and/or an independent component analysis.

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: An implantable cardiorenal stimulator delivers cardiorenal stimulation in response to detection of decompensation associated with heart failure. The cardiorenal stimulation includes delivering renal stimulation pulses to promote diuresis and/or natriuresis and delivering cardiac stimulation pulses to enhance the diuretic and/or natriuretic effects of the renal stimulation pulses.

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: An implantable system for ambulatory monitoring of a high-risk heart failure patient includes a first pressure sensor implantable within an abdomen of the patient for sensing and generating an output representative of a baseline intra-abdominal pressure value of the patient and for chronically sensing and generating an output representative of an intra-abdominal pressure value of the patient at periodic intervals. At least one second implantable sensor is provided for sensing and generating an output representative of a second physiological parameter of the patient. Additionally, the system includes a processor for correlating the output of the first pressure sensor and the second physiologic sensor, and for comparing differences between the baseline intra-abdominal pressure value and subsequent intra-abdominal pressure values. The processor can reside in another implantable device or in an external device/system.

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: A medical electrical lead comprises a flexible, elongate lead body extending along a longitudinal axis and having a proximal end and a distal end. A protective distal tip structure is disposed on the distal end of the lead body. The tip structure includes a plurality of compliant projections each extending distally from the distal end of the body in the direction of the longitudinal axis. The projections are configured to contact and bear against cardiac tissue when the lead is implanted, and are deformable under the action of an axially or radially directed force. The projections optionally include a coating over a substrate. The coating can include a hydrogel material and/or a pharmaceutical agent such as a steroid for reducing inflammation at the implantation site.

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: 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 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 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: 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.

Abstract: A myocardial lead attachment system for securing a distal end of a lead within a myocardium of a patient's heart. The system includes a lead body, an anchor mechanism formed of a bioabsorbable or biodegradable polymer for engaging a surface of the patient's heart and a surface feature formed on a portion of the lead body for promoting formation of scar tissue around said portion of the lead body.

Abstract: A medical electrical lead includes a drug eluting coating provided over at least a portion of the lead body. The drug eluting coating can be provided over at least a portion of the lead body and adjacent to at least one electrode located on the lead body. The drug eluting coating can include at least one matrix polymer layer including a polymer admixed with a therapeutic agent. The therapeutic agent, for example, can be an anti-proliferative agent or an anti-inflammatory agent. The matrix polymer can include a medical adhesive. The rate of elution of the drug from the matrix polymer layer is affected by the drug to polymer ratio of the drug in the matrix polymer layer.

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: The present invention is a myocardial lead attachment system for securing a distal end of a cardiac lead within a myocardium of a patient's heart and anchoring against an epicardium of the patient's heart. The system includes an anchor configured to advance in a first orientation and anchor against an epicardial surface in a second orientation and a tether having a proximal end and a distal end. The anchor is coupled to the distal end of the tether. The system includes a cardiac lead having a lead body, a lumen extending through the lead body, a conductive member, a proximal end, a distal end, and an electrode configured for stimulating the myocardium located at the distal end. The lead body and the lumen are configured such that the lead body can be threaded over the proximal end of the tether and slideably advanced over the tether toward the anchor during implantation. The system includes a fixation mechanism at the distal end of the cardiac lead.