Abstract: A cardiac lead adapted for fixation at least partially within a cardiac vessel. The lead includes, in one embodiment, an elongate lead body defining a proximal region and a distal region including a distal end region having at least one electrode and a distal tip. The distal end region is configured such that the electrode and the distal tip can be implanted in the cardiac vessel. Stiffening structures in the distal region of the lead are adapted to stiffen selected portions of the lead for fixation of the electrode within the cardiac vessel. In some embodiments, the stiffening structures include an implantable member adapted to be implanted in a lumen of the lead. In other embodiments, the stiffening structures include a sheath adapted to be deployed over the lead body. In still other embodiments, the stiffening structures are integral to the lead and/or the lead body.

Abstract: A cardiac rhythm management system comprises a medical electrical lead, a pressure sensing element, and an implantable pulse generator. The lead is sized to be advanced through the right atrium and coronary sinus into a coronary vein adjacent to the left ventricle. The lead includes an opening intermediate its proximal and distal ends, and a lumen extending longitudinally within the body in communication with the opening. The pressure sensing element is movably disposed in lead lumen and is dimensioned to extend through the opening in the lead, and includes a flexible, elongated conductive member having a distal end, and a pressure transducer coupled to the distal end of the conductive member. The pulse generator is configured to receive cardiac rhythm signals from the electrode and fluid pressure signals from the pressure transducer.

Abstract: A lead assembly for an implantable medical device includes a lead body having a proximal end, a distal end, and a longitudinal axis that extends between the proximal end and distal end. The lead assembly also includes a strain relief tube that surrounds a portion of the lead body. The strain relief tube includes a flexible material configured to include contours such that the portion of the lead body surrounded by the strain relief tube maintains a formed shape that varies from the longitudinal axis of the lead body. The contours vary in response to forces on the lead body to prevent strain at the distal end of the lead body.

Abstract: A device and method for accessing a pericardial space of the heart includes a shaft having a cavity at a distal end, a suction lumen terminating in a distal port within the cavity and a hollow needle having a distal tip extending into the cavity. The cavity may be a recess in the shaft into which the distal tip of the needle fixedly protrudes. In other embodiments, the cavity is formed by an inflatable member positioned at the distal end of the shaft and the needle is slidable relative to the shaft. Suction is applied at the cavity to draw a pericardial bleb. The needle pierces the pericardial bleb for accessing the pericardial space and also facilitates delivery of payloads into the pericardial space.

Abstract: A cardiac rhythm management system comprises a medical electrical lead, a pressure sensing element, and an implantable pulse generator. The lead is sized to be advanced through the right atrium and coronary sinus into a coronary vein adjacent to the left ventricle. The lead includes an opening intermediate its proximal and distal ends, and a lumen extending longitudinally within the body in communication with the opening. The pressure sensing element is movably disposed in lead lumen and is dimensioned to extend through the opening in the lead, and includes a flexible, elongated conductive member having a distal end, and a pressure transducer coupled to the distal end of the conductive member. The pulse generator is configured to receive cardiac rhythm signals from the electrode and fluid pressure signals from the pressure transducer.

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 catheter assembly for cannulating an ostium of a coronary sinus of a heart comprises an outer catheter member and an inner catheter member. The outer catheter member has a distal end portion including a deflectable distal end and a lumen extending through the deflectable distal end, wherein the distal end portion includes regions of varying stiffness and has a pre-formed curvature. The inner catheter member is slidably and rotatably disposed within the lumen of the outer catheter member, and has a distal end portion including a distal end, and a lumen extending through the distal end. The distal end portion of the inner catheter member has regions of varying stiffness and a pre-formed curvature. The outer and inner catheter members are configured such that relative translation and rotation of the outer and inner catheter members causes the distal end of the outer catheter member to assume a plurality of two and three dimensional shapes.

Abstract: An implantable medical device includes an adhesive surface portion provided over or formed on an outer surface thereof. The adhesive surface portion is capable of bonding to body tissue to secure and fixate the implantable medical device at a desired implantation location within the patient's body. The adhesive surface portion can be used in combination with other fixation mechanisms to secure and fixate the implantable medical device at the desired implantation location.

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 having a pre-formed biased portion is adapted for implantation with a body vessel and for connection to a signal generator. The lead is constructed and arranged so that when it is implanted, the electrodes are biased toward a vessel wall by the preformed biased portion, which operates to fixate the lead against the vessel wall.

Abstract: A peel-away lead implant tool is described. The peel away lead implant tool is adapted to be disposed over the terminal connector of a lead during an implantation procedure to protect the terminal connector. The peel-away lead implant tool includes a flexible polymer sheath including electrical contacts formed in a contact region of the sheath. The electrical contacts can be either metal foil contacts or conductive polymer contacts and extend from an outer surface to an inner surface of the sheath such that when the testing apparatus is coupled to the lead implant tool, the electrical contacts are pressed into electrical contact with the ring electrodes located on the terminal connector. The lead implant tool also includes various removal means facilitating the easy removal of the implant tool from the terminal connector when the implantation procedure is complete.

Abstract: Cardiac lead implantation systems, devices, and methods for lead implantation are disclosed. An illustrative cardiac lead implantation system comprises a mapping guidewire including one or more electrodes configured for sensing cardiac electrical activity, a signal analyzer including an analysis module configured for analyzing an electrocardiogram signal sensed by the mapping guidewire, and a user interface configured for monitoring one or more hemodynamic parameters within the body. The sensed electrical activity signal can be used by the analysis module to compute a timing interval associated with ventricular depolarization.

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: A two-part system for securing and stabilizing a lead at a location within a patient's internal jugular vein adjacent a region of the vagus nerve to be stimulated is described. The two-part system includes a lead and a stent-like fixation member that is provided separate from the lead. The stent-like fixation member is used to secure an electrode region of the lead at a location within the internal jugular vein adjacent the vagus nerve. The stent-like fixation member urges the electrode region of the lead against the vessel walls of the internal jugular vein such that at least one electrode is oriented in a direction towards the vagus nerve. In one example, the stent-like fixation member includes a channel sized to receive and retain a portion of the lead therein.

Abstract: A system including two neurostimulation leads can be used for stimulating a select region of a nerve within a nerve bundle. For example, two leads can be used to stimulate a select region of the vagus nerve located within a patient's carotid sheath. The first neurostimulation is positioned within the carotid sheath and the second neurostimulation lead is positioned external to the carotid sheath. Each of the first and second neurostimulation leads includes at least one electrode defining an electrode array about the select region of the nerve. The electrode array, and more particularly, the different possible electrode vector combinations provided by the first and second neurostimulation leads facilitate steering of stimulation current density fields as needed or desired between the electrodes to effectively and efficiently treat a particular medical, psychiatric, or neurological disorder.

Abstract: A multipolar lead evaluation device may be configured to easily permit electrical contact to be made between a pacing system analyzer and the terminal pin and each of the terminal contacts of an implantable lead without damaging the implantable lead. Alligator clips may be used to secure electrical conductors from the pacing system analyzer to spring contact clips disposed within the lead evaluation device.

Abstract: A medical electrical lead adapted to be at least partially implanted in a cardiac vessel includes a fixation feature operable to change from an undeployed configuration to a deployed configuration in which the fixation feature is adapted to engage an inner surface of the cardiac vessel. A tendon is disposed within a lumen of the lead and is operatively connected to the fixation feature and adapted to cause the fixation feature to change from the undeployed configuration to the deployed configuration for acute and/or chronic fixation of the lead. In one embodiment, the fixation feature includes a deflectable region of the lead which in the deployed configuration causes a surface of the lead body to engage the inner surface of the cardiac vessel. In another embodiment, the fixation feature includes a radially expandable structure for engaging the inner surface of the vessel in the deployed configuration.

Abstract: A lead having pre-formed biased portion 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 the preformed biased portion, which operates to fixate the lead against the vessel wall.

Abstract: The present invention is device for delivering an electrode into a lateral vein of the coronary sinus. The device includes a support structure, a stent, a tether coupled to the stent and a removable sheath disposed about the stent. The stent is carried on the support structure and is deployable from a first collapsed configuration to a second expanded configuration for engaging the inner walls of the selected vessel. The sheath is sized to retain the stent in the first collapsed configuration. The electrode is carried on the stent or on a lead threaded over the tether.