Abstract: Some embodiments relate to a method of implanting a cardiac lead. An expansion module is implanted in a target region within vasculature, the target region being defined by a portion of a brachiocephalic vein and a portion of a corresponding subclavian vein. The expansion module is transitioned from a collapsed state to an expanded state within the target region to contact the vasculature. A cardiac lead is implanted through the expansion module, the cardiac lead defining an intermediate section corresponding to the target region. The intermediate section of the cardiac lead includes a surface treatment adapted to reduce at least one of cell proliferation, thrombosis, fibrosis, and inflammation at the target region.

Abstract: Devices, systems, and methods for implanting and testing multi-conductor electrical leads are disclosed. An illustrative implant tool for use with an implantable lead includes a main body, a plurality of spring contact members, and a knob mechanism. The main body of the implant tool includes a distal clamping mechanism with an opening adapted to frictionally receive a terminal boot of the implantable lead. The spring contact members are configured to provide an interface for connecting electrical connectors from a Pacing System Analyzer (PSA) or other testing device to the terminal contacts on the implantable lead. A knob mechanism coupled to the main body can be actuated to engage a terminal pin of the implantable lead, allowing an implanting physician to engage a fixation helix into body tissue by rotating the mechanism.

Abstract: A medical electrical lead configured to be coupled to a pulse generator in a cardiac rhythm management system. The lead comprises a proximal terminal connector configured for coupling the lead to the pulse generator, and a plurality of longitudinally arranged lead segments each configured to exhibit one or more predetermined physical characteristics based on the implantation location for the respective segment. The lead segments may be pre-fabricated as separate modules optimized for the operating environment and/or delivery requirements of the respective segments. The pre-fabricated modules are longitudinally arranged and joined to form the lead.

Abstract: According to embodiments of the present invention, a cardiac lead system adapted for fixation to a vessel including an expandable fixation mechanism adapted to engage an inner surface of the vessel and a lead member comprising an anchor structure at distal end, the anchor structure configured to removably engage with fixation mechanism. Such anchor structure may be helical, and may removably engage fixation mechanism upon rotation or an application of torque, and may be extendable and/or retractable. Fixation mechanism may be polymer coated weave and/or mesh to trap anchor structure. Lead member and/or fixation mechanism may include electrodes and/or sensors, and lead member may include L-shape, S-shape, spiral, and/or sinusoidal shape for positioning of electrodes and/or sensors or for facilitated engagement of anchor structure. A guide wire attached to fixation mechanism during deployment may, prior to detachment, serve to guide lead member to a target site at fixation mechanism.

Abstract: The present invention is directed to a medical electrical lead including an insulative lead body formed, at least in part, from a polyisobutylene urethane, urea or urethane/urea copolymer. In some applications, the lead body can include at least one outer tubular insulator and/or an inner elongated member formed from a polyisobutylene urethane, urea or urethane/urea copolymer. Portions of the lead body formed form the polyisobutylene urethane, urea or urethane/urea copolymer can be either extruded or molded.

Abstract: According to embodiments of the present invention, a cardiac lead system adapted for fixation to a vessel including an expandable fixation mechanism adapted to engage an inner surface of the vessel and a lead member comprising an anchor structure at distal end, the anchor structure configured to removably engage with fixation mechanism. Such anchor structure may be helical, and may removably engage fixation mechanism upon rotation or an application of torque, and may be extendable and/or retractable. Fixation mechanism may be polymer coated weave and/or mesh to trap anchor structure. Lead member and/or fixation mechanism may include electrodes and/or sensors, and lead member may include L-shape, S-shape, spiral, and/or sinusoidal shape for positioning of electrodes and/or sensors or for facilitated engagement of anchor structure. A guide wire attached to fixation mechanism during deployment may, prior to detachment, serve to guide lead member to a target site at fixation mechanism.

Abstract: In accordance with various aspects of the invention, copolymers comprising styrene and isobutylene monomers are used in the construction of implantable and insertable medical devices for electrical stimulation, including, for example, electronic signal generating components and electrical leads for such devices.

Abstract: A system for therapeutically stimulating a His bundle includes an implantable pulse generator and a multi-polar medical electrical lead. The generator is configured for subcutaneous implantation and to generate a pacing stimulus. The lead includes a connector assembly, a flexible tubular body, a distal tip assembly and coil conductors. The body extends intravascularly from the generator to a location proximate the His bundle and includes a proximal end, a distal end, and a longitudinal lumen. The tip assembly includes an electrode, a fixation helix, and a shank portion. The helix extends to a location proximate the His bundle and is operable as an electrically isolated electrode. The shank portion extends within the lumen and includes a receptacle for receiving a stylet tip. The conductors extend longitudinally through the lumen and are coupled to the electrode and the helix. One or both of the conductors defines a stylet lumen.

Abstract: A medical electrical lead includes a flexible, insulative body defining a proximal region, an intermediate region, and a distal region. The proximal region is configured to be implanted at a subcutaneous implantation site, and is dimensioned to extend from an implantation location of the pulse generator to a location distal to a cardiovascular system entry site. The intermediate region is configured to extend distally from the proximal region to a location distal to a superior vena cava of a patient's heart, and the distal region is configured to extend distally from the intermediate region within the patient's heart. The lead further includes an armoring layer disposed on the lead body covering at least the proximal region.

Abstract: A medical electrical lead configured to be coupled to a pulse generator in a cardiac rhythm management system. The lead comprises a proximal terminal connector configured for coupling the lead to the pulse generator, and a plurality of longitudinally arranged lead segments each configured to exhibit one or more predetermined physical characteristics based on the implantation location for the respective segment. The lead segments may be pre-fabricated as separate modules optimized for the operating environment and/or delivery requirements of the respective segments. The pre-fabricated modules are longitudinally arranged and joined to form the lead.

Abstract: An implantable medical system includes a medical lead including an insulating sheath and a conductor and an anchoring device. The anchoring device defines an inner lumen adapted to coaxially receive the medical lead, where the inner lumen has an effective diameter. The anchoring device includes a sleeve including a substantially elongate body defining an outer surface and an inner bore. The anchoring device also has a compression member including a first end, a second end, and an intermediate portion between the first and second ends. The compression member is at least partially embedded in the sleeve such that compression of the first and second ends of the compression member toward one another causes the effective diameter of at least a portion of the inner lumen of the anchoring device to reversibly increase.

Abstract: A transvenously implantable medical device (TIMD) includes an electrical lead and a control module. The electrical lead includes one or more electrodes and is adapted for transvenous implantation. The electrical lead is also pre-biased to expand from a collapsed state to an expanded state to mechanically engage an internal wall of a blood vessel. The control module is secured to and in electrical communication with the electrical lead. The control module includes a signal management component and a power component disposed in a housing adapted for implantation into the blood vessel. The control module is adapted for at least one of stimulating and sensing a physiologic response using the one or more electrodes of the electrical lead.

Abstract: Some embodiments relate to a method of implanting a cardiac lead. An expansion module is implanted in a target region within vasculature, the target region being defined by a portion of a brachiocephalic vein and a portion of a corresponding subclavian vein. The expansion module is transitioned from a collapsed state to an expanded state within the target region to contact the vasculature. A cardiac lead is implanted through the expansion module, the cardiac lead defining an intermediate section corresponding to the target region. The intermediate section of the cardiac lead includes a surface treatment adapted to reduce at least one of cell proliferation, thrombosis, fibrosis, and inflammation at the target region.

Abstract: According to embodiments of the present invention, a cardiac lead system adapted for fixation to a vessel including an expandable fixation mechanism adapted to engage an inner surface of the vessel and a lead member comprising an anchor structure at distal end, the anchor structure configured to removably engage with fixation mechanism. Such anchor structure may be helical, and may removably engage fixation mechanism upon rotation or an application of torque, and may be extendable and/or retractable. Fixation mechanism may be polymer coated weave and/or mesh to trap anchor structure. Lead member and/or fixation mechanism may include electrodes and/or sensors, and lead member may include L-shape, S-shape, spiral, and/or sinusoidal shape for positioning of electrodes and/or sensors or for facilitated engagement of anchor structure. A guide wire attached to fixation mechanism during deployment may, prior to detachment, serve to guide lead member to a target site at fixation mechanism.

Abstract: An implantable endocardial defibrillation lead having a looped cable conductor for conducting at least high voltage defibrillation shocks. A coil electrode is connected to an elongated, flexible, electrically non-conductive lead body and is supplied with electrical power for delivering electrical shocks to the heart through a looped cable conductor that extends through the lead body and is associated with a power source.

Abstract: An apparatus and method for laser stripping coated cables for endocardial defibrillation leads comprising a jig for holding at least one insulated wire, the jig having a base plate, a linear stripping area on the plate, a first clasp mounted on the plate for holding a first end of the wire, at least two primary pins mounted on the plate on a first side of the linear stripping area, at least one secondary pin mounted on the plate on a second side of the linear stripping area, and a second clasp mounted on the plate for holding a second end of the wire; and a laser effective to remove insulation from the insulated wire, the laser being mounted to effectively remove insulation in the linear stripping area.

Abstract: An apparatus and method for laser stripping coated cables for endocardial defibrillation leads comprising a jig for holding at least one insulated wire, the jig having a base plate, a linear stripping area on the plate, a first clasp mounted on the plate for holding a first end of the wire, at least two primary pins mounted on the plate on a first side of the linear stripping area, at least one secondary pin mounted on the plate on a second side of the linear stripping area, and a second clasp mounted on the plate for holding a second end of the wire; and a laser effective to remove insulation from the insulated wire, the laser being mounted to effectively remove insulation in the linear stripping area.

Abstract: An implantable endocardial defibrillation lead having an elongated lead body with multiple lumens therein. Windows, cut through the lead body, provide access to selected ones of the lumens at selected locations along the lead body. In addition, a method and an apparatus for forming windows in a multilumen lead body are disclosed. A ferromagnetic stylet is inserted into a selected lumen. The lead body is oriented in a jig by application of an electromagnetic field. A grinder or punch cuts a window into the selected lumen.

Abstract: An implantable endocardial defibrillation lead having an elongated lead body with multiple lumens therein. Windows, cut through the lead body, provide access to selected ones of the lumens at selected locations along the lead body. In addition, a method and an apparatus for forming windows in a multilumen lead body are disclosed. A ferromagnetic stylet is inserted into a selected lumen. The lead body is oriented in a jig by application of an electromagnetic field. A grinder or punch cuts a window into the selected lumen.

Abstract: An implantable endocardial defibrillation lead having a looped cable conductor for conducting at least high voltage defibrillation shocks. A coil electrode is connected to an elongated, flexible, electrically non-conductive lead body and is supplied with electrical power for delivering electrical shocks to the heart through a looped cable conductor that extends through the lead body and is associated with a power source.