Abstract: A cardiac stimulation system and method delivers a left ventricle stimulator from a right ventricle lead system in the right ventricle chamber, into a right side of an interventricular septum at a first location, and transmuscularly from the first location to a second location along the left side of the septum. The left ventricle stimulator is affixed at the second location for transmuscular stimulation of the left ventricle conduction system. A biventricular stimulation system further includes a right ventricle stimulator also delivered by the right ventricle lead system to the first location along the right side of the septum for right ventricular stimulation. An energy source is coupled to the transmuscular stimulation system, i.e., a pacemaker, and/or defibrillator, or to enhance contractility, and may be coupled directly or via “leadless” system(s). Various highly beneficial particular arrangements of stimulators and leads are further described.

Abstract: A lead of the present invention comprises an electrode array adapted to be stably anchored at a selected location within the vena cava of a human patient. The electrode array may take various shapes, including helical, annular and linear. The electrode array is connectable to an electrical stimulation means such as an implantable pulse or signal generator. Electrical stimulation applied to a selected region of the vena cava and across the wall of the vein, that is, transvascularly, to the vagus nerve or branches thereof, depolarizes the nerve to thereby effect control of the heart rate.

Abstract: Disclosed herein is an implantable medical lead. In one embodiment, the lead includes a ring electrode, a tip electrode, first and second helically wound coaxial conductor coils, and a distal coil transition. The coils extend between the proximal and distal ends of the lead. The distal coil transition is proximal to the ring electrode and near the distal end and is where the first coil transitions from being outside the second coil proximal of the distal coil transition to being inside the second coil distal of the distal coil transition.

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: A cardiac rhythm management system for securing a cardiac lead within a patient's heart is provided. According to the present invention, the cardiac rhythm management system includes a fixation helix for securing and stabilizing the lead at a target location in a patient's heart. The fixation helix is adapted to extend from a first position disposed over the electrode to a second position located distally to the distal end of the cardiac lead.

Abstract: An implantable medical lead comprises an elongated body extending between a proximal end and a distal end, and a helical fixation member extending from the distal end of the elongated body. The helical fixation member is configured to fix the implantable medical lead at an implant site and includes a tip comprising a first surface generally facing a center axis of the helical fixation member.

Abstract: Bio-impedance may be used for navigation systems to chronically implant pacing and defibrillation leads in the heart using anon-fluoroscopic position sensing unit (PSU), such as a modified LocaLisa® system from Medtronic Inc., which allows for variable frequency sampling of the position of electrode of a catheter. The PSU injects small AC signals via surface electrodes in three orthogonal axes, each on a slightly different frequency (e.g., near 30 KHz). Indwelling electrodes electrically connected to the PSU resolves the magnitude of induced voltage for each of the three frequencies, thus measuring voltage for each of the three axes. Voltages are divided by induced current to yield impedance in each axis for each electrode. Impedance is proportional to position within the body. Such a system requires that a conductive material, such as a retractable helical tip-electrode, be exposed during implantation.

Abstract: The lead includes a helical fixation member coupled to the distal end of the lead body. The helical fixation member has at least one internal reservoir and a plurality of elution ports in fluid communication with the internal reservoir. A therapeutic agent composition is disposed within the internal reservoir. Additionally, the helical fixation member includes a sealed distal end to prevent coring of the cardiac tissue.

Abstract: A stimulation electrode is produced having a porous film layer and being partially coated with an insulating parylene (polyparaxylylene) film, whose insulating film has a dielectric breakdown voltage of greater than 100 V. Parylene is deposited on the entire surface of a porous film coating and then partially removed again by plasma. After the partial removal of the parylene, this porous film still has a capacitance of greater than 15 mF/cm2 in a physiological NaCl solution at a frequency of 0.1 Hz. For the stimulation electrode, the transition from the insulating film to the porous film is formed so that the film thickness of the parylene film decreases continuously. In this way, a stimulation electrode having a porous film layer and being partially coated with an insulating parylene film is provided, whose electrode on the non-insulating parylene film-coated surface has a capacitance of greater than 15 mF/cm2 in a physiological NaCl solution at a frequency of 0.

Abstract: Defibrillator lead designs and methods for manufacturing a lead having a fibrosis-limiting material covering, a shocking coil electrode, and an implantable lead body are disclosed herein. The shocking coil electrode includes at least one laser welded portion.

Abstract: Medical electrical leads equipped with spacer elements and configured for use during medical procedures such as magnetic resonance imaging (MRI) are disclosed. An illustrative medical electrical lead includes a proximal connector, an insulated lead body including at least one electrode, a helically coiled conductor wire, and a helically coiled spacer element interstitially disposed between adjacent turns of the conductor wire.

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: A screw-in electrode probe for cardiological application comprises an oblong electrode body (1), a supply line (10) running therein, and an electrode head (3) on the distal end (2). The latter is provided with housing (5), a shaft (6) mounted therein so it is rotatable and axially displaceable, and a corkscrew-like screw-in electrode (4) on the shaft (6). A contact spring in the form of an essentially planar spiral spring (11) is situated between these components, whose leg ends (12, 13) are in sliding contact with the housing (5) or the shaft (6), respectively, while exerting a radially directed spring force (F).

Abstract: The disclosure describes medical tools such as implantable leads that have internal drive shafts for deploying an extendable member and associated clinician tools for engaging the drive shaft.

Abstract: An implantable electrode device, particularly a cardiological electrode device, comprises an oblong, hose-like electrode body and a helical screw-in electrode, which is displaceable on the distal end of the electrode body between a retracted passive position inside the electrode body and an extended, active fixing position outside the electrode body, which is displaceable by a rotational movement of its electrode line, with the aid of a spindle-type cam controller, between the retracted passive position and the extended fixing position. The cam controller is formed by a separate cam coil, which is fixedly mounted in the electrode body and coaxially to the electrode supply line and, in addition, by a cam body, which is mounted on the electrode supply line rotationally fixed thereto and engages in the cam coil.

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: Implantable medical leads with magnetic shielding and methods of shielding implantable leads from magnetic fields during medical procedures such as magnetic resonance imaging (MRI) are disclosed. An exemplary implantable medical lead includes a helically coiled inner electrode conductor wire, a helically coiled outer electrode conductor wire disposed radially about the inner electrode conductor wire, and at least one layer of insulation that electrically isolates the inner and outer electrode conductor wires. The inner electrode conductor wire can have a hollowed, multifilar configuration including six or more co-radially wound wire filars. The outer electrode conductor wire is electrically isolated from the inner electrode conductor wire, and may have either a single or double filar configuration.

Abstract: An implantable medical device that includes an elongated body having a proximal end and a distal end, a helical fixation member extending from the distal end of the elongated body, the helical fixation member including a distal tip for affixing the distal end of the elongated body at an implant site, and a tracking member extending from the distal end of the elongated body, through the helical fixation member and outward from the distal tip of the helical fixation member for tracking along an implant pathway during implantation of the implantable medical device.

Abstract: An intravascular medical electrical lead includes a conformal coating including at least one layer formed from a poly-p-xylylene polymer. The coating is lubricious and provides an effective barrier against moisture and gases preventing degradation of the lead body material preventing corrosion of the conductor.

Abstract: A medically implantable lead configured for insertion into a human or animal body to be attached in the body with its distal end to tissue inside the body, as a rotatable helix at a distal end thereof that can be screwed into the tissue. The helix serves as an attachment of the lead to the tissue as well as a conductor for conducting electrical signals to the tissue through electrically conducting surfaces on the helix. The surfaces of the helix are partly insulated so as to restrict the conducting of signals between the helix and the tissue to desirable regions. The surfaces of the helix facing inwardly, toward an inner bore of the helix, are electrically insulated. In a method for manufacturing such a lead, the wire forming the helix has protrusions in desired areas and the wire including the protrusions is coated with an electrically insulating layer. The protrusions are uncovered from the insulating layer in desired regions.

Abstract: A cardiac rhythm management device that includes a lead and a pulse generator. The lead can comprise a lead body, a helical composite electrode, a composite conductor and a proximal connector. The helical composite electrode can have first and second electrodes in a co-axial configuration. The composite connector can electrically connect the first and second electrodes to the proximal connector. The proximal connector can be configured to couple to the pulse generator.

Abstract: An implantable medical device that includes an elongated body having a proximal end and a distal end, a helical fixation member extending from the distal end of the elongated body, the helical fixation member including a distal tip for affixing the distal end of the elongated body at an implant site, and a tracking member extending from the distal end of the elongated body, through the helical fixation member and outward from the distal tip of the helical fixation member for tracking along an implant pathway during implantation of the implantable medical device.

Abstract: A cardiac pacemaker—electrode (1) provided at its distal end with a helical screw (2), connected to an electrically conductive supply helix (5), which in turn can be coupled to a cardiac pacemaker via a connector (5) and a connector pin (6) and in turn can be rotated for rotating and axially adjusting the helical screw (2). A stylet (8) can be inserted through an interior longitudinal cavity of the supply helix (4), and includes a distal end (9) that can be directly or indirectly connected or coupled to the rotational helical screw (2), with the stylet (8) additionally being directly or indirectly coupled in a rotationally fixed fashion to the proximal end of the supply helix (4) so that when the stylet (8) is rotated both the supply helix (4) as well as the helical screw (2) are rotated without any considerably different rotation of the supply helix (4) occurring.

Abstract: A pacemaker electrode (1) with a helical coil (3) arranged in a metal housing (7) is provided. So that no undesired electrical voltage pulse can occur if there is mutual contact between the helical coil (3) and metal housing (7), a permanent electrical connection of the metal housing (7) is provided with the helical coil (3). This electrical connection is realized by an electrical conductor (8), which is advantageously constructed as an additional coil and which is connected directly or indirectly to a part, which is permanently connected in an electrically conductive way to the rotating plug pin (4) and the feed line coil (4) connected to this plug pin and leading to the helical coil (3) by a wiping contact (12).

Abstract: A device terminating a distal end of a cardiac stimulator lead for transmitting electrical signals from a pacemaker to a location within a heart for stimulating cardiac tissue of the heart said device comprising an electrically conductive helix configured to interact with said cardiac tissue by attachment to said cardiac tissue with a rotating screw motion, said helix having a plurality of helical flights respectively oriented at a screw pitch a tube containing said helix and allowing rotation of said helix in an interior of said tube said tube having an interior post that protrudes between adjacent flights of said helix a rotatable shaft on which said helix is mounted, rotation of said shaft in respective directions causing outward and inward screwing motion of said helix relative to said tube by engagement of said post with said flights of said helix, and said shaft having a stop surface thereon that, when said stop surface reaches said post, interrupts said screw rotation of said helix by abutment of the s

Abstract: A medical electrical lead, which may be useful in coupling an implantable medical device, is comprised of a first and second lead. The first lead has a first electrode coupled adjacent a distal end portion thereof. The distal end portion of the first lead is anchorable in the coronary sinus of a patient. The second lead is coupled with and moveable along the first lead. The second lead has a second electrode located thereon wherein the position of the first and second electrodes may be varied relative to one another by movement of the second lead along the first lead. A rubber tip holds the relative position of each electrode.

Abstract: The invention provides for an electrical lead, a steerable sheath and steerable catheter, a sheath and catheter that attach to cardiac tissue via an anchor screw, and a method of pacing, particularly via the atrioventricular septum.

Abstract: An implantable lead for delivering electrical stimuli to a human heart has a stimulating electrode for transmitting electrical stimuli to the myocardium after implantation, and a mapping electrode for use during implantation. The mapping electrode is configured to deliver electrical stimuli to the heart and to sense intrinsic cardiac activity, for the purpose of finding a suitable fixation position in the myocardium. During the implantation procedure, the mapping electrode is electrically connected to the conductor. The lead is configured to electrically disconnect the mapping electrode from the conductor after a suitable fixation position has been determined.

Abstract: A lead having an extendable and retractable fixation mechanism has a rotating terminal pin at the terminal end which rotates the fixation mechanism at the distal end. As the terminal pin is rotated, the fixation mechanism is extended or retracted from the distal end of the lead. A threaded collar allows for the fixation mechanism to smoothly extend and retract from the lead, and allows for a 1:1 turn ratio between the terminal pin and the fixation mechanism. A fluoroscopic ring disposed at the distal end of the lead provides information during the implantation process.

Abstract: A lead assembly includes an elongate body having a conductor electrically coupled with an electrode coupled to the elongate body. The lead assembly includes a push tube extending along at least a portion of the elongate body. A distal tip is coupled to the elongate body substantially adjacent to the distal end of the elongate body. The distal tip is sized and shaped to couple with a push tube distal end. In one option, the distal tip includes a seat to receive the push tube distal end. In another option, the seat is a side rail seat and a guide wire extends along the elongate body and is slidably coupled with the side rail seat. The lead assembly includes, optionally, an active fixation device slidably coupled with a portion of the elongate body, and the active fixation device is sized and shaped to couple with the push tube.

Abstract: A bipolar pacing and sensing lead incorporates a range of active surface areas for each of the anode and cathode electrodes, and a range of inter-electrode spacings between the anode and cathode electrodes which, in combination, provide acceptable near-field signal amplitudes and attenuate the amplitudes of unwanted signals, such as far-field R-waves, far-field P-waves, and T-waves.

Abstract: An implantable medical lead is provided, which includes an elongated lead body having a distal end portion and a pull cable lumen. A pull extends within the pull cable lumen and is fixedly coupled to the distal end portion. The pull cable is configured to be moved axially relative to the elongated lead body to form a fixation loop.

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 lead having an extendable and retractable fixation mechanism has a rotating terminal pin at the terminal end which rotates the fixation mechanism at the distal end. As the terminal pin is rotated, the fixation mechanism is extended or retracted from the distal end of the lead. A threaded collar allows for the fixation mechanism to smoothly extend and retract from the lead, and allows for a 1:1 turn ratio between the terminal pin and the fixation mechanism. A fluoroscopic ring disposed at the distal end of the lead provides information during the implantation process.

Abstract: A bipolar pacing and sensing lead incorporates a range of active surface areas for each of the anode and cathode electrodes, and a range of inter-electrode spacings between the anode and cathode electrodes which, in combination, provide acceptable near-field signal amplitudes and attenuate the amplitudes of unwanted signals, such as far-field R-waves, far-field P-waves, and T-waves.

Abstract: Various configurations of systems that employ leadless electrodes to provide pacing therapy are provided. In one example, a system that provides multiple sites for pacing of myocardium of a heart includes wireless pacing electrode assemblies that are implantable at sites proximate the myocardium using a percutaneous, transluminal, catheter delivery system. Also disclosed are various configurations of such systems, wireless electrode assemblies, and delivery catheters for delivering and implanting the electrode assemblies.

Abstract: A cardiac rhythm management system for securing a cardiac lead within a patient's heart is provided. According to the present invention, the cardiac rhythm management system includes a fixation helix for securing and stabilizing the lead at a target location in a patient's heart. The fixation helix is adapted to extend from a first position disposed over the electrode to a second position located distally to the distal end of the cardiac lead.

Abstract: An implantable myocardial stimulation lead comprises a lead body having a distal end and a proximal end, and an electrical connector carried by the proximal end of the lead body. An electrode header carried by the distal end of the lead body has an axis and includes a helical fixation element extending along the axis, the electrode header having a surface configured to receive a driver for rotating the electrode header to screw the helical fixation element into the tissue of the heart. The lead body carries along its length a strain relief member resisting excessive bending of the lead body.

Abstract: An implantable medical lead is provided with a distal guidewire extension. A flexible distal guidewire extension, which may take the form of a helically wound wire around a tapered core, extends from the distal end of a lead body. The extension may exit a tip electrode, which may be a generally rounded electrode or an active fixation electrode. The distal guidewire extension is preferably insulated, but may be provided with an uninsulated segment for serving as an electrode.

Abstract: A proximal end of a lead body carries a connector assembly. A first electrical conductor within the lead body electrically connects a tip electrode to a first electrical contact on the connector assembly. A collar electrode is carried by a distal end portion of the lead body. A second electrical conductor within the lead body electrically connects the collar electrode to a second electrical contact on the connector assembly. A ring electrode, carried by the distal end portion of the lead body, is disposed proximally of the collar electrode in spaced-apart relationship thereto and is connected through a switching device to a node point along the first conductor. The switching device has a first state permitting an electrical current to be conducted between the ring electrode and the node point and a second state in which the ring electrode is electrically isolated from the node point. Preferably, the switching device comprises a diode.

Abstract: An implantable lead includes a defibrillation electrode and a sensor coupled thereto. The electrode and sensor are positioned along a body of the lead such that, when a fixation element couples the lead to an endocardial surface of a right ventricle, the sensor is located in a high flow region and a portion of the defibrillation electrode is located in proximity to a right ventricular apex.

Abstract: A distal tip coupled to a body of an implantable medical device includes a canted passageway extending distally from a lumen of the body and an opening terminating the passageway and positioned in proximity to a distal end of the distal tip; a helical fixation element coupled to an elongated member extending within the lumen of the body is adapted to deflect along the canted passageway of the distal tip. The elongated member is adapted to move the helical member through the passageway of the distal tip and out from the opening and to rotate the helical element thereby affixing the helical element into an implant site.

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: A catheter system includes a mapping catheter having an open lumen and a mapping arrangement provided at a distal end of the mapping catheter. A balloon catheter is movably disposed within the open lumen of the mapping catheter. The balloon catheter has an open lumen dimensioned to receive a lead. A balloon arrangement is provided at a distal end of the balloon catheter and inflatable with an inflation mechanism provided at a proximal end of the balloon catheter. The balloon arrangement is dimensioned to prevent movement of the lead upon inflation of the balloon arrangement, and to permit movement of the lead within the open lumen of the balloon catheter upon deflation of the balloon arrangement.

Abstract: An implantable lead for use with an implantable medical device includes a lead body with first and second electrical conductors extending between its proximal and distal ends. An electrical connector at the proximal end of the lead body includes terminals electrically connected to the first and second conductors. First and second coaxial active fixation helices are coupled to the lead body's distal end, one being an anode, the other an electrically isolated cathode. Each helix has an outer peripheral surface with alternating insulated and un-insulated portions along its length with about a half of the surface area being insulated. The un-insulated portions of the helices may be formed as a plurality of islands in the insulated portions, or as rings spaced by insulative rings, or as longitudinally extending strips spaced by longitudinally extending insulative strips.

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 lead for delivering electrical signals to and/or receive electrical signals from a human heart that includes a solid inner conductor, and a fixation device having a titanium nitride coated surface and electrically coupled to the inner conductor. A steroid is applied to the titanium nitride surface of the fixation device, and at least one layer of insulation is positioned around the inner conductor. A conductive coil is positioned around and is insulated from the inner conductor, an electrode ring electrically coupled to the conductive coil is positioned around and is electrically isolated from the inner conductor, and an insulating spacer is positioned between and electrically isolates the ring electrode and the fixation device.

Abstract: Improved pacing thresholds for capturing the heart are achieved by forming a discontinuity in the cardiac tissue of the heart chamber, disposing a pacing electrode at a distance less than a space constant of the cardiac tissue from the discontinuity in the cardiac tissue, and applying a stimulus of a first polarity at an energy insufficient to cause the directly stimulated tissue adjacent to the pacing electrode to propagate a depolarization wave through the cardiac tissue mass of the heart chamber but sufficient to induce a transmembrane potential change at the tissue adjacent to the discontinuity that results in a propagated wave front. Thus, pacing energy is advantageously reduced.

Abstract: The present invention provides for a method and apparatus providing pacing to improve the hemodynamics of the heart for patients with AV nodal block, right/left bundle branch block, and heart failure. A lead body having at least one conductor with an insulative sleeve is introduced into the right atrium of a heart. A partially masked helical electrode connected to the conductor is then secured preferably into the atrial aspect of the atrioventricular septum. The electrical conductor is then rotated such that an unmasked portion of the electrode is moved to a depth within the heart tissue substantially near the heart's intrinsic conduction system. This method and apparatus allow pacing in a natural manner via low power stimulation of the heart's intrinsic conduction system.