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: 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: 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: Systems and methods for steering one or more stimulation fields to a selected nerve target, thereby optimizing one or a combination of low stimulation thresholds, desired therapy outcomes, or a minimization of adverse stimulation side-effects. An array of electrodes disposed, at least in part, on two or more neural stimulation leads are used for steering the stimulation fields to the selected nerve target and are positioned adjacent the selected target. The stimulation may be titrated based on, among other things, a detected physiologic response to the applied stimulation.

Abstract: Miniature implantable medical devices each include a fixation mechanism to prevent the device from migrating in the body of a patient after implantation. The fixation mechanism is activated after the device is positioned in the body. In one embodiment, the miniature implantable medical devices each include a circuit to deliver neurostimulation. In one embodiment, the fixation mechanism includes one or more externally activated anchoring devices each configured to switch from a substantially non-anchoring state to a substantially anchoring state in response to an externally applied energy. In another embodiment, implantable medical devices are magnetically attracted to each other to prevent the devices from migrating in the body after implantation.

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: Medical lead systems utilizing electromagnetic bandstop filters are provide which can be utilized in a magnetic resonance imaging (MRI) environment for patients who have implanted medical devices. Such lead systems may be advantageously used in left ventricle cardiac stimulation systems, neuro-stimulation systems, and deep brain electrodes used for the treatment of Parkinson's disease and other movement disorders. The bandstop filters, which include a tuned parallel capacitor and inductor circuit, are backwards compatible with known implantable deployment systems.

Abstract: A neural stimulation system delivers neural stimulation to the vagus nerve and senses a signal indicative of laryngeal activity resulting from the neural stimulation. The signal indicative of laryngeal activity is used, for example, to guide electrode placement, determine stimulation threshold, detect lead/electrode problems, detect neural injury, and monitor healing processing following the electrode placement inside the body of a patient.

Abstract: Described herein are a method and apparatus for introducing instrumentation into the lymphatic system that can be used for physiological monitoring and/or delivery of therapy. Such instrumentation, for example, may include one or more sensors for measuring physiological variables and/or one or more instruments for delivering therapy that is adapted to be disposed within a lymphatic vessel.

Abstract: An implantable neural stimulation system includes an implantable medical device having a neural stimulation circuit and at least one implantable lead configured to allow one or more stimulation electrodes to be placed in one or more lymphatic vessels of a patient, such as the patient's thoracic duct and/or vessels branching from the thoracic duct. Neural stimulation pulses are delivered from the implantable medical device to one or more target regions adjacent to the thoracic duct or the vessels branching from the thoracic duct through the one or more stimulation electrodes.

Abstract: An apparatus includes a lead body extending from a proximal end to a distal end and having an intermediate portion therebetween. The lead body includes two or more individually insulated conductors, where a first conductor traverses along less than an entire length of the lead body and a second conductor traverses from the proximal end to the distal end of the lead body. Optionally, the first conductor has a different material than the second conductor, for instance having differing electrical properties and/or differing stiffnesses. A method includes varying the stiffness of a coiled conductor assembly including winding a plurality of conductors to form the coiled conductor assembly, and pulling at least one loop of a first conductor away from the coiled conductor assembly.

Abstract: A cardiac rhythm management system includes a lead assembly for intracardiac mapping, pacing, and drug delivery. The lead assembly includes an implantable endocardial lead having a proximal end for connection to an implantable cardiac rhythm management device and a distal end for disposal in an intracardiac region. The lead includes a pacing-sensing electrode and a drug delivery device, both located at or near the distal end. A lumen is within and extends throughout the lead, with an opening at or near the proximal end and another opening at or near the distal end. The lumen provides for access to the intracardiac region by a steerable stylet and a hollow needle, one at a time. The steerable stylet allows for electrophysiological mapping of the intracardiac region. The hollow needle allows for delivery of chemical, biochemical, and/or biological substance to the intracardiac region.

Abstract: Implantable cardiac monitoring and stimulation devices and methods using cardiac leads employ coated fixation arrangements. The coating, such as an expanded polytetrafluoroethylene, reduces exit block by reducing the tissue response to the fixation arrangement, decreasing the amount of fibrotic tissue, and reducing exit block. An epicardial lead may include a lead body with one or more electrical conductors with associated insulators and an electrode assembly situated at the distal end. The electrode assembly includes an electrode having an active fixation arrangement such as a helical fixation element. The fixation arrangement is completely or partially coated with a fluoropolymer or has a sleeve on some or all of the active fixation arrangement. The coating or sleeve may include a steroid or other pharmacological eluting arrangement disposed on the active fixation arrangement.

Abstract: A cardiac rhythm management system includes a lead assembly for intracardiac mapping, pacing, and drug delivery. The lead assembly includes an implantable endocardial lead having a proximal end for connection to an implantable cardiac rhythm management device and a distal end for disposal in an intracardiac region. The lead includes a pacing-sensing electrode and a drug delivery device, both located at or near the distal end. A lumen is within and extends throughout the lead, with an opening at or near the proximal end and another opening at or near the distal end. The lumen provides for access to the intracardiac region by a steerable stylet and a hollow needle, one at a time. The steerable stylet allows for electrophysiological mapping of the intracardiac region. The hollow needle allows for delivery of chemical, biochemical, and/or biological substance to the intracardiac region.

Abstract: An apparatus includes a lead body extending from a proximal end to a distal end and having an intermediate portion therebetween. The lead body includes two or more individually insulated conductors, where a first conductor traverses along less than an entire length of the lead body and a second conductor traverses from the proximal end to the distal end of the lead body. Optionally, the first conductor has a different material than the second conductor, for instance having differing electrical properties and/or differing stiffnesses. A method includes varying the stiffness of a coiled conductor assembly including winding a plurality of conductors to form the coiled conductor assembly, and pulling at least one loop of a first conductor away from the coiled conductor assembly.

Abstract: A connector for connecting to an energy source such as a pulse generator for a cardiac stimulator system. The connector assembly includes a pin, at least one ring and a sleeve composed of an insulative hard polymer molded between the pin and ring such that the sleeve provides electrical insulation between the pin and ring and mechanically couples the pin and ring.

Abstract: A medical electrical lead employs a load bearing sleeve arrangement. A medical electrical lead includes an outer sleeve, having proximal and distal ends, and is formed of a first material. At least one electrical conductor is situated within the outer sleeve and extends between the proximal and distal ends of the outer sleeve. At least one electrode is electrically coupled to the electrical conductor. A load bearing sleeve extends between the proximal and distal ends of the outer sleeve. The load bearing sleeve is formed of a second material different from the first material. The load bearing sleeve offers resistance to axial loading forces applied to the lead. The load bearing sleeve can be coextensive with the outer sleeve or extend along at least the majority of the length of the outer sleeve.

Abstract: A cardiac rhythm management system provides an endocardial cardiac rhythm management lead with an at least partially dissolvable coating at least partially on insulating portions of the lead body at or near its distal end. Upon dissolution, the coating promotes tissue ingrowth to secure the lead in place within fragile vascular structures or elsewhere. Dissolution of one such coating releases a therapeutic agent, such as a steroid that modifies the fibrotic scar tissue content of tissue ingrowth, such that the resulting bond between the tissue and the lead is weak, so that the lead can be easily extracted if desired. One such lead includes an insulating elongate body carrying at least. The lead also includes an at least partially dissolvable coating on an insulating portion of the peripheral distal lead surface. The coating provides one or more of a rough surface, a porous surface, or a swollen surface after being exposed to an aqueous substance.

Abstract: An injectable cardiac lead for stimulating a heart includes an anchor and a tether. The anchor has first and second electrically active areas spaced apart and electrically isolated from one another. The tether has a distal end mechanically coupled to the anchor and a proximal end adapted for coupling to a cardiac rhythm management device. The tether comprises first and second electrically conductive cables electrically isolated from one another and electrically coupled to the first and second electrically active areas, respectively.