Abstract: The present invention is directed to a cardiac lead for delivery to the left side of a patient's heart including a self-expanding fixation method positioned over the distal portion of the lead. The self-expanding fixation member is capable of automatically expanding from a collapsed state to an expanded state upon deployment at a target site in a cardiac vessel. The fixation member is configured such that in the expanded state it is biased to a side of the lead body.

Abstract: A seal adapted for use with medical devices is provided. The medical device may be a lead having a distal tip adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity. The lead assembly in one embodiment includes an atraumatic tip. A seal is provided within the lead tip assembly, which prevents or limits further entry of fluids through the lead tip. The lead may be a left ventricular lead with a hemostasis mechanism provided therewithin.

Abstract: A cardiac lead system includes a cardiac lead having a lumen, and a guide member displaceable within the lumen. The guide member includes a guide wire extension that extends distal to the elongated body of the guide member. The guide wire extension is dimensioned to pass through an external distal opening of the cardiac lead lumen. Engagement of stop features or a stop mechanism of the cardiac lead system provides a push point for advancing the cardiac lead system through the patient's anatomy.

Abstract: A lead having an atraumatic tip is adapted for implantation on or about the heart within the coronary vasculature and for connection to a signal generator. The lead is constructed and arranged so that when it is implanted, the electrodes are housed in the coronary vasculature and are biased toward a vessel wall by a preformed biased portion. Near the distal end, the lead has an optional tapered portion and a flexible portion, where the flexible portion is more flexible than the biased portion.

Abstract: Methods facilitate inserting a cardiac lead into a patient's vasculature. A cardiac lead system includes a cardiac lead having a lumen, and a guide member displaceable within the lumen. The guide member includes a guide wire extension that extends distal to the elongated body of the guide member. The guide wire extension is dimensioned to pass through an external distal opening of the cardiac lead lumen. Engagement of stop features or a stop mechanism of the cardiac lead system provides a push point for advancing the cardiac lead system through the patient's anatomy.

Abstract: A cardiac lead assembly includes a sheath disposed over a majority of the outer surface of a cardiac lead body including a fixation helix located at its distal end. The sheath protects the fixation member during delivery of the lead assembly to a target location within a patient's heart. The sheath can include one or more means adapted for splitting the sheath such that the sheath can be removed from about the lead body once the lead has been implanted.

Abstract: Implantable cardiac monitoring and stimulation methods and devices with epicardial leads having sensor feedback. A fixed or extendable/retractable sensor may be displaceable within the lead's lumen and configured to sense the presence of an anatomical feature or physiological parameter of cardiac tissue in proximity with the lead body's distal end. The sensor may include an ultrasonic sensing element, a perfusion sensor, a photoplethysmographic sensor, or a blood oximetry sensor. Methods of determining suitability for implanting a lead involve the steps of accessing an epicardial surface of the heart, and moving the cardiac lead to an implant site at the epicardial surface. A transmitted signal is directed at the implant site. A reflected signal is received, indicative of the presence of a blood vessel at the implant site. A determination may be made to determine whether the implant site is suitable or unsuitable based on the reflected signal.

Abstract: A system and method for navigating coronary vasculature involves use of a guide catheter system which includes a guide catheter, a navigator catheter longitudinally displaceable within the guide catheter, and a deflection arrangement provided at a distal end of the navigator catheter. The guide catheter is advanced to at least a patient's coronary sinus ostium, and the navigator catheter is extended from the guide catheter to a location proximate or within an angled vein distal to the coronary sinus ostium. Using the deflection arrangement, a guide wire passing through the navigation catheter is directed into the angled vein. A lead having an open lumen is advanced over the guide wire to direct the lead to an implant site within the angled vein.

Abstract: In one embodiment, the present invention provides a cardiac lead device including a fixation mechanism slidably attached to the lead such that when the fixation mechanism is expanded in to contact with a body lumen, the lead may be moved relative to the fixation mechanism if desired. Such lead movement may be limited by complimentary structure on the lead body and the fixation mechanism that prevents the lead from moving unless sufficient force is applied to the lead.

Abstract: Implantable cardiac monitoring and stimulation methods and devices with epicardial leads having sensor feedback. A fixed or extendable/retractable sensor may be displaceable within the lead's lumen and configured to sense the presence of an anatomical feature or physiological parameter of cardiac tissue in proximity with the lead body's distal end. The sensor may include an ultrasonic sensing element, a perfusion sensor, a photoplethysmographic sensor, or a blood oximetry sensor. Methods of determining suitability for implanting a lead involve the steps of accessing an epicardial surface of the heart, and moving the cardiac lead to an implant site at the epicardial surface. A transmitted signal is directed at the implant site. A reflected signal is received, indicative of the presence of a blood vessel at the implant site. A determination may be made to determine whether the implant site is suitable or unsuitable based on the reflected signal.

Abstract: Lead assemblies and methods for sensing or stimulating a first myocardial contact area and a second myocardial contact area when implanted are discussed. A lead assembly includes a lead body having at least one preformed biased portion at an intermediate portion thereof and an unbiased portion disposed between the biased portion and the distal end thereof. A first electrode is located at the preformed biased portion and is arranged to provide sensing or stimulation to the first myocardial contact area. A second electrode is located on the lead body distal to, and spaced apart from, the first electrode and is arranged to provide sensing or stimulation to a distinct second myocardial contact area spaced apart from the first myocardial contact area. In an example, the lead assembly includes a second preformed biased portion at the distal end of the lead body. In another example, the lead assembly includes additional electrodes.

Abstract: Methods for medical lead fixation in coronary veins according to embodiments of the present invention include advancing a lead body into a branch vessel of a coronary vein, inserting a fixation line and expandable anchor structure through the lead body, past a distal end of the lead body, and into the branch vessel, engaging a wall of the branch vessel with the expandable anchor structure, and coupling the fixation line with the lead body. Apparatus for medical lead fixation in a coronary vein according to embodiments of the present invention include a lead body having one or more electrodes, a fixation line, an expandable anchor structure coupled to the fixation line, the fixation line and anchor structure deployable through the lead body into the branch vessel, and a means for coupling the lead body to the fixation line.

Abstract: Approaches for selecting an electrode combination of multi-electrode pacing devices are described. Electrode combination parameters that support cardiac function consistent with a prescribed therapy are evaluated for each of a plurality of electrode combinations. Electrode combination parameters that do not support cardiac function are evaluated for each of the plurality of electrode combinations. An order is determined for the electrode combinations based on the parameter evaluations. An electrode combination is selected based on the order, and therapy is delivered using the selected electrode combination.

Abstract: A lead assembly includes a lead body and a tether coupled thereto. The tether includes at least one sensor, such as a pressure sensor.

Abstract: In one embodiment, the present invention provides a cardiac lead device including a fixation mechanism slidably attached to the lead such that when the fixation mechanism is expanded into contact with a body lumen, the lead may be moved relative to the fixation mechanism if desired. Such lead movement may be limited by complimentary structure on the lead body and the fixation mechanism that prevents the lead from moving unless sufficient force is applied to the lead.

Abstract: A seal adapted for use with medical devices is provided with a lead having a distal tip electrode. The distal tip of the lead is adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity. The lead can include a fixation helix for securing the electrode to cardiac tissue. The lead assembly can alternatively include an open lumen lead tip. A seal is provided within the lead tip assembly such that the seal is expanded to prevent or limit further entry of fluids through the lead tip. The seal includes an expandable matrix, such as a hydrogel. The seal is formed on or within the lead when the lead and the seal comes into contact with a fluid and expands. The seal is also formed as a plug which is deployed through the medical device, and expands as the plug absorbs fluid. A housing incorporating the seal can also be attached to a portion of the medical device to provide the seal.

Abstract: The present invention is directed to a cardiac lead for delivery to the left side of a patient's heart including a self-expanding fixation method positioned over the distal portion of the lead. The self-expanding fixation member is capable of automatically expanding from a collapsed state to an expanded state upon deployment at a target site in a cardiac vessel. the fixation member is configured such that in the expanded state it is biased to a side of the lead body.

Abstract: A medical electrical lead configured for use in stimulating the left side of the heart (i.e., the left ventricle). In one embodiment, the lead includes an elongate lead body including an inner surface. An inflatable member is disposed on the outer surface of the body between its proximal and distal ends, the inflatable member being adapted when inflated to impart a radial force on and frictionally engage a surface of the coronary sinus or coronary vein for fixation of the distal end of the lead therein. The lead further includes a conductive member extending from the proximal end toward the distal end, and an inner insulating layer positioned between the conductive member and the inner surface of the body. Separation between the inner insulating layer and the inner surface of the body defines an inflation lumen in fluid communication with the inflatable member.

Abstract: Medical electrical leads are provided including fixation features for acute and chronic fixation of a portion of the respective leads within the cardiac venous system. The medical electrical lead includes an elongate body having proximal and distal regions. Tissue contacting portions are selectively located in the distal region to contact an inner surface of the cardiac vessel when the lead is in an implanted position. The tissue contacting portion(s) include fixation features adapted to frictionally engage the inner surface of the cardiac vessel and promote tissue in-growth for chronic fixation. In some embodiments, the fixation features are detachable from the lead such that the lead can be extracted from its implanted position after tissue in-growth occurs.

Abstract: A left ventricular lead is provided for placement in a branch vessel of the coronary sinus, the vessel having a vessel wall and an adjacent myocardium. The lead includes a lead body having a central lumen extending therethrough, at least a first electrode on the lead body and at least a first orientation feature protruding from the lead body for orienting one or more of the electrodes into contact with the myocardium. The lead may also include a pre-shaped curvature. The orientation feature may also aid in steering the lead into a selected branch vessel of the coronary sinus and in fixing the lead within the branch vessel.