Abstract: An implantable endocardial lead for use with a cardiac stimulation device includes an active fixation helix disposed at the distal end of the lead. The helix is constructed of flat wire having a non-circular cross section. The helix may be fixed or movable between a retracted position fully within the lead and an extended position advanced beyond the distal end of the lead.

Abstract: An introducer system and method for positioning and fixedly engaging a lead at an implantation site that includes a torque transfer sheath, extending from a proximal end to a distal end, receiving the lead, an outer sheath, having a distal end, receiving the lead positioned within the torque transfer sheath, and a handle operable between a first position enabling advancement and retraction of the lead through the handle and a second position fixedly engaging a proximal end of the lead within the handle. The lead is advanced through the outer sheath to extend outward a predetermined distance from the distal end of the outer sheath and the fixation helix is rotated through the predetermined distance to be fixedly engaged at the implantation site in response to simultaneous rotation and advancement of the lead and the torque transfer sheath through rotation and advancement of the handle in the second position.

Abstract: A medical electrical lead includes a first electrode and a second electrode positioned distal to the first electrode; a first portion of a first cable conductor extends through a channel of the first electrode to couple with the second electrode and a second cable conductor, insulated from the first cable conductor and coupled to the first electrode, is wound about a second portion of the first cable which extends proximally from the first portion.

Abstract: An implantable device such as a lead is adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity. The implantable device includes an active fixation assembly for securing the device to tissue. The active fixation assembly includes one or more recessed portions therein.

Abstract: An epicardial lead installation tool having an elongated tool body extending between a tool body proximal and distal ends and encloses a tool body lumen. At least one suction pad supported by a suction pad strut extends distally to a distal end surface of the tool body distal end. A lead implantation tool extending between implantation tool proximal and distal ends is inserted through the tool body lumen to dispose the implantation tool distal end proximate to the tool body distal end. The lead implantation tool distal end is adapted to engage the distal electrode head of an epicardial lead to enable the extension of the assembly of the of the lead installation tool, the lead implantation tool and the epicardial lead through a skin incision and to apply the suction pad against the epicardium. Suction is applied through the suction pad to affix it to the epicardium while the implantation tool proximal end is manipulated to affix the distal fixation mechanism to the myocardium at the implantation site.

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 exceeding 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: An intracardial electrode lead comprises a distal end, a proximal end and an elongate electrode lead body which includes a helical coil having a lumen and a sheath enclosing the helical coil. The distal end of the electrode lead carries a an electrode. The electrode is electrically connected to a connection at the proximal end of the electrode lead for communication with a medical device. The distal end has a sleeve with a proximal end and a distal end, which is enclosed by the distal end of the helical coil at the sleeve proximal end and contacts a lip seal at its distal end. The lip seal elastically closes a distal opening of the lumen. The sleeve is also electrically connected to the electrode, which has an external surface and projects distally beyond the lip seal.

Abstract: An intravascular electrode line is provided with a shaping suitable for fixing in a blood vessel. The shaping is three-dimensional and has line portions enclosing an elongated hollow space, with a pitch direction that is different in relation to the longitudinal direction of the hollow space.

Abstract: A medical system incorporating fluid delivery and lead delivery lumens dispense fluid into a volume of tissue. The fluid comprises or contains a pharmacologic, genetic, or biologic agent. The fluid may be dispensed initially during implantation or later using a minimally invasive medical procedure.

Abstract: A set for installing an intracardiac lead equipped with a screw in a wall of the endocardium, particularly a stimulation or defibrillation lead. This set comprises a removable stylet (50), able to be introduced inside the sheath (12) of the lead-body and mobile in translation and rotation therein. The stylet has at its distal extremity a mechanism (56) for coupling in rotation to allow the rotation (28) of the lead-head (10). The stylet (50) includes: a central core (52, 71) carrying at its distal extremity the aforementioned coupling mechanism, and at its proximal extremity a handling body (32) for handling by the physician and a hollow tube (54) axially placed around the core.

Abstract: An implantable lead adapted to transmit electrical signals between a connector assembly on a proximal end of the lead and at least one electrode carried by a distal end of the lead comprises a helical fixation element extendable and retractable from the distal end of the lead, the header comprising (a) an inner header part comprising an electrically conductive material that is substantially transparent fluoroscopically, the inner header part having a distal end, (b) an outer header part comprising an electrically insulating material, and (c) a collar attached to the distal end of the inner header part. The collar comprises a material that is substantially opaque fluoroscopically. The collar may be electrically conductive, and electrically and mechanically connected, preferably by means of an overlap joint, to the distal end of the inner header part.

Abstract: A helical element for insertion into tissue comprises a helical element having an insertion end, a protruding end and an open central area within the wire, rods, filaments, cables or the like that form the helix. The helical element has at least its insertion end covered by a cap of a water-soluble or water-dispersible composition. The cap is provided with a surface shape in a cross-section in which surface variations are present in the cross-section which create a surface orientation where a line from the center of the cross-section can intersect the surface, and a line perpendicular to said radius at a point of intersection with said surface forms four quadrants, three of said quadrants containing water-soluble or water-dispersible cap material. There is either a hollow area within the composition within the open central area or the material is more porous than the remaining material.

Abstract: An electrical lead includes an elongate body having a proximal end and a fixation member joined to the elongate body and distally disposed from the proximal end of the elongate body, wherein the fixation member is capable of being extended from and retracted toward the elongate body. A method includes advancing an electrical lead into vasculature and extending a fixation member from the body of the electrical lead to fixedly engage the electrical lead within the vasculature. The method may further include retracting the fixation member toward the body of the electrical lead to unengage the electrical lead within the vasculature and retracting the electrical lead from the vasculature.

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 body implantable stimulation lead is provided including tip electrode patterns and configurations producing low noise, clean sensed signals devoid of far field components, such sensed signals being generated irrespective of the direction of the incident depolarization wavefront. The invention also provides high pacing impedances and advantageous anode-to-cathode surface area ratios. Further, implantable leads utilizing the features of the present invention are particularly suitable for left side stimulation therapies.

Abstract: Methods and endocardial screw-in leads for enabling provision of electrical stimulation to the heart, particularly the His Bundle in the intraventricular septal wall. An endocardial screw-in lead having a distal end coupled to a retractable fixation helix wherein a distal portion of the fixation helix extends beyond the lead distal end when the fixation helix is fully retracted or partially extended is positioned in proximity to the His Bundle in the septal wall. The lead body is rotated to attach the distal portion of the fixation helix into the septal wall. The fixation helix is rotated with respect to the lead body to fully extend the fixation helix so that a portion of the fixation helix is in proximity to the His Bundle, enabling provision of electrical stimulation to the His Bundle and/or to sense electrical signals of the heart traversing the His Bundle through the fixation helix.

Abstract: An implantable electrode and electrode system for contacting living biological material that includes an electrode assembly including at least a portion of the electrode, adapted to contact the living biological material at an electrode/tissue interface, exhibiting conduction that is substantially limited to electron or electron vacancy conduction. The implantable electrode is manufactured by coupling an electrode to a distal end of a conductor, and forming at least one surface of the electrode with a material that conducts electricity in a manner that is substantially limited to electron or electron vacancy conduction when the at least one surface is in contact with the living matter.

Abstract: An electrical lead equipped with cathode and anode active succession electrodes for positioning in the vicinity of the His bundle tissue. The lead includes a lead body for carrying conductors coupled between electrodes located at or near the distal lead end and a connector assembly located at the proximal lead end for connecting to an implantable pacemaker. The electrode is shaped, at the distal end, for positioning and attachment in the His bundle and branches thereof, cathode and anode electrodes co-extensive with the lead body. The cathode and anode electrodes may be helical screw-in type or equivalent electrodes adapted for secure fixation deep within the His bundle tissue or the tissue in the vicinity of the His bundle.

Abstract: A helical needle is attached to a surgical probe to aid in the insertion of the probe into a tissue mass. The tip of the helical needle penetrates the tissue mass in advance of the tip of the probe. The probe is rotated to push the helical shaft of the needle into the tissue mass in the direction of rotation. As the helical shaft advances into the tissue mass, the probe advances with it. Rotating the probe in the opposite direction causes the helical needle and probe to withdraw from the tissue mass. Rotation of the probe and needle is more effective in penetrating rubbery and calcified growths than the conventional method of pushing the probe, and it enables the precise placement of the probe. The helical needle also enables insertion of the probe in situations where an inconvenient angle of entry makes it difficult to push the probe along.

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 transvenous implantable medical device adapted for implantation in a body, and which is particularly adapted for use in a vessel such as the coronary sinus or cardiac great vein. The implantable medical device may take the form of a lead or catheter, and includes an extendable distal fixation member such as a helix. In one embodiment, the fixation member is a helix constructed of a shape memory metal or other super-elastic material. Upon deployment, the helix assumes a predetermined helix shape larger than the diameter of the lead body diameter. The helix functions to wedge or fix the lead within the vessel in a manner that does not impede the flow of blood through the vessel. The helix may be retracted for ease of repositioning and/or removal. In one embodiment of the invention, the fixation member may be advanced using a stiffening member such as a stylet. In another embodiment, the helix is coupled to a coiled conductor such that rotation of the conductor extends or retracts the helix.

Abstract: A lead assembly having a push-extendable active fixation mechanism. As the terminal end of the lead is pushed, the active fixation element extends from the lead body to a predetermined extension length. Optionally, a seal is formed at the distal end when the terminal is pushed and the terminal moves axially. A further option includes providing a snap fit connection with the terminal when the terminal end is pushed and the active fixation element is fully extended.

Abstract: A medical electrical lead includes a first low voltage electrode adapted for intimate contact with tissue at an implant site, in order to provide pacing stimulation, and a second low voltage electrode positioned in proximity to the first electrode, isolated from the first electrode and adapted to function in conjunction with the first electrode to provide bipolar sensing of near-field signals. A porous layer is formed over the second electrode; the porous layer allows conduction therethrough while preventing contact between the second electrode and tissue in proximity to the implant site.

Abstract: An implantable endocardial lead for use with a cardiac stimulation device includes an electrically active housing including a tubular end region extending to a terminal rim at the distal end of the lead and an electrical conductor within the lead extending between proximal and distal ends. An active fixation electrode within and spaced from the electrically active housing includes an electrically active helix coaxial with the endocardial lead coupled to the distal end of the electrical conductor and movable between a retracted position fully within the housing and an extended position advanced beyond the terminal rim of the housing for effecting penetration into the myocardial tissue. A guide system located proximally of the active fixation electrode serves to rotate the electrically active helix about the longitudinal axis as the helix is moved between the retracted and extended positions.

Abstract: A medical electrical lead is provided that is readily manufactured using a minimal number of parts, has a reduced size and improved reliability during implantation and extraction. The lead includes a modular electrode head assembly that is joined to a lead body at a butt joint. The butt joint is stabilized in at least four possible ways: insulation tubing that spans the joint is bonded to the electrode head assembly; two cabled conductors extending the length of the lead body are coupled to the electrode head assembly; an electrode head alignment peg interlocks with and is bonded to the lead body; and a coil electrode is positioned across the butt joint on the outer diameter of the assembly and the lead body. The lead size is minimized by using a compact retraction stop mechanism, a low-friction, press-fit drive shaft seal, and a small diameter coiled conductor insulated by a thin-walled insulating tube.

Abstract: A lead assembly that includes a body with a proximal end and a distal end and at least one conductor disposed within the body. A distal electrode is at the distal end of the body and is electrically coupled with at least one of the conductors. A first electrode is also on the body and electrically coupled with at least one of the conductors. The lead assembly further includes a neck that is less stiff than the body. The neck is between the distal end of the body and the first electrode assembly. A fixation mechanism at the distal end of the body is capable of securing the lead assembly to a septum in a heart. A method is provided which includes advancing a lead assembly using a catheter until the lead assembly is near tissue, such as a septum in a heart. The lead assembly includes a body and a neck that is less stiff than the body. The method further includes affixing a distal end of the body to the septum, and removing the catheter to allow at least a portion of the neck to drop against the septum.

Abstract: A technique for removing from a body an implanted lead including an active fixation electrode includes the operation of releasably attaching an elongated stylet to the distal end of the implanted lead, specifically, to the electrode at the distal end of the lead. This results in a reasonably unified stylet and implanted lead structure whereby withdrawal of the stylet and of the implanted lead as a unit facilitates the complete removal of the implanted lead from the body. A threaded tip end of the stylet is used for threaded engagement with a tapped bore in the electrode. The threaded tip end of the stylet becomes locked to the electrode by rotating in one direction the threaded portion into the threaded bore and the stylet is removable by counter-rotating the threaded tip end of the stylet relative to the electrode.

Abstract: An implantable lead, being either a fixed or retractable/extendable lead, having a distal tip electrode is adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity. The electrode includes a mechanical fastener such as a fixation helix for securing the electrode to cardiac tissue, which may or may not be electrically active. The implantable electrode with a helical tip includes an electrode which has a distal end and a proximal end. A helix is disposed within the electrode, where the helix is aligned along a radial axis of the electrode. The electrode further includes one or more of the following features: the helix having a coating of an insulating material on a surface of the helix, a porous conductive surface at a base of the helix, or a porous conductive element at the end of the electrode having an insulating coating covering from 5-95% of the surface of the porous conductive element.

Abstract: A multicontact electrode array suitable for implantation in living tissue includes a distal end having multiple spaced-apart ring contacts or a pattern of spaced-apart electrode contacts carried on a flexible carrier. Each electrode contact is resistance welded to a respective wire that is wound helically inside a silicon tube. The center of the helix defines a lumen wherein a positioning stylet, or other suitable positioning tool, may be removably inserted when the electrode array is implanted. The electrode array is made using a method that includes, as an initial step, winding lead wires around a suitable mandrel forming a helix configuration. Next, a non-conductive silicone tube jacket is placed around the wound wires, exposing the distal lead ends of the wires at a distal end of the tube. A welding process is then used to bond each wire tip to a corresponding metal electrode contact which has been preassembled by resistance welding to a metal foil structural carrier.

Abstract: An epicardial screw-in lead is disclosed which includes an elongated lead body, an electrode housing at a distal end of the lead body for stimulating cardiac tissue, and a helical fixation screw within the electrode housing which can be extended to affix the electrode housing to the cardiac tissue. Preferably at least a portion of the helical fixation screw is electrically active. A lead implantation kit is also disclosed that can include the screw-in lead, a screwdriver tipped stylet for activating the screw, and a flexible guiding sheath for directing the tip of the stylet to the electrode housing.

Abstract: A medical lead for tissue stimulation and sensing is provided, the lead having an electrode with an active fixation mechanism. The active fixation mechanism using a conductive spring element or wave washer to maintain electrical contact after extension of the active fixation mechanism. The active fixation mechanism is engaged by rotating a piston within the electrode housing which advances the fixation mechanism distally.

Abstract: An implantable endocardial lead includes an electrical conductor coupled at its distal end to an active fixation electrode movable between a retracted position and an extended position advanced beyond the lead end for penetration into the myocardial tissue. A resilient coupling mechanism maintains electrical continuity between the active fixation electrode and an electrically active housing throughout movement of the electrode. In one instance, a conductive coupling is slidably received on a conductive shaft and is fixed to the electrically active housing. A compression spring is received on the conductive shaft intermediate and engaged with the conductive coupling and with a conductive ring stop member projecting radially from the conductive shaft. In another instance, an annular track member integral with the electrically active housing has an annular recess surrounding the conductive shaft and a metallic coil spring is received in the annular recess and slidably engageable with the conductive shaft.

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.

Abstract: An esophageal stethoscope includes a tubular flexible body having an acoustic input region. A carrier member, which is separate from the tubular flexible body, is selectively engageable with the tubular flexible body either proximally or distally of the acoustic input region. The carrier member carries one or more devices for providing esophageal recording, monitoring or stimulation functions. For transesophageal cardiac pacing, electrodes are mounted to the carrier member such that engagement of the carrier member with the tubular flexible body functions to convert the esophageal stethoscope to a pacing stethoscope. To carry out a sensing, recording or monitoring function, such as esophageal oximetry, one or more oximetry probes are mounted to the carrier member such that engagement of the carrier member with the esophageal stethoscope converts the stethoscope for use in an oximetry sensing application.

Abstract: A set for installing an intracardiac lead equipped with a screw in a wall of the endocardium, particularly a stimulation or defibrillation lead. This set comprises a removable stylet (50), able to be introduced inside the sheath (12) of the lead-body and mobile in translation and rotation therein. The stylet has at its distal extremity a mechanism (56) for coupling in rotation to allow the rotation (28) of the lead-head (10). The stylet (50) includes: a central core (52, 71) carrying at its distal extremity the aforementioned coupling mechanism, and at its proximal extremity a handling body (32) for handling by the physician and a hollow tube (54) axially placed around the core.

Abstract: A lead assembly includes a flexible lead body which extends from a proximal end to a distal end, the lead body includes one or more conductors therein. The lead assembly further includes a braided torque transmission member, and optionally at least one coating of insulative material coated directly on the torque transmission member.

Abstract: A medical lead for tissue stimulation and sensing is provided, the lead having an electrode with an active fixation mechanism. The active fixation mechanism using a conductive spring element or wave washer to maintain electrical contact after extension of the active fixation mechanism. The active fixation mechanism is engaged by rotating a piston within the electrode housing which advances the fixation mechanism distally.

Abstract: A medical electrical lead that includes an indicator member that acts as a visual aid in implanting an electrode into a body tissue while using a fluoroscope. In an example embodiment, a medical electrical lead assembly includes an electrode head member, an electrode and a shaft member, the shaft member being retractable and extendible within the electrode head member. Each of the electrode, electrode head member and shaft member have, respectively, a distal end and a proximal end, and the electrode head member has an outer surface. The medical lead assembly includes an indicator coil member disposed on the outer surface of the electrode head member that is spaced laterally away from the shaft member in a first retracted position. The shaft member moves in alignment with the indicator coil member in a second extended position to indicate that the electrode extends out from the electrode head member.

Abstract: A medical electrical lead, having an elongated lead body which includes an elongated insulative sheath having proximal and distal ends and which carries spaced first and second electrical components. The first and second electrical components are mechanically and electrically coupled to one another by a coil/core structure extending within the insulative sheath. The coil/core structure is made of lengths of fiber cord twisted around one another, with a metal coiled conductor wound around the lengths of twisted fiber cord. The coil/core structure may include two lengths of a single fiber cord, folded back upon itself to define a loop at one end thereof. The first electrical component may be provided with a longitudinal lumen extending therethrough and the fiber core may be tied into a knot located within the lumen of the first electrical component and the coil wound around the first electrical component.

Abstract: A cardioversion arrangement having an electrode arrangement for the intracardial discharge of electrical pulses in the atrium of a heart, having an electrode line and in the region of its distal end a plurality of electrodes which can be electrically connected by way of the electrode line to an electrical pulse-discharging device and a defibrillator, wherein the electrode-bearing region at the distal end of the electrode line is split into two branches of which one is in the form of a septal branch and the other is in the form of a lateral branch for assuming a septal position and a lateral position in the atrium of a heart, wherein the branches are respectively provided with electrodes in such a way that each electrode of a branch is associated in pair-wise manner with an electrode of the other branch, for the discharge of bipolar pulses, and the cardioversion arrangement is designed to record intra-atrial electrograms by means of the electrodes by receiving electrical signals between a respective two of the

Abstract: A technique for removing an implanted lead from a body includes the steps of releasably attaching a stylet to both the distal end of the implanted lead and to the proximal end of the implanted lead. This results in a substantially unified stylet and implanted lead structure whereby withdrawal of the stylet and of the implanted lead as a unit facilitates the complete removal of the implanted lead from the body. A threaded tip end may be used for threaded engagement with a tapped bore at the distal end of the implanted lead and at the proximal end, attachment being provided by a threaded region on the stylet distant from the threaded tip end for threaded engagement with a tapped bore of a connector pin integral with the implanted lead. In this instance, the diameter of the proximal threaded region on the stylet is greater than that of the threaded tip end.

Abstract: An implantable lead, being either a fixed or retractable/extendable lead, having a distal tip electrode is adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity. The electrode includes a mechanical fastener such as a fixation helix for securing the electrode to cardiac tissue, which may or may not be electrically active. The implantable electrode with a helical tip includes an electrode which has a distal end and a proximal end. A helix is disposed within the electrode, where the helix is aligned along a radial axis of the electrode. The electrode further includes one or more of the following features: the helix having a coating of an insulating material on a surface of the helix, a porous conductive surface at a base of the helix, a porous conductive element at the end of the electrode having an insulating coating covering from 5-95% of the surface of the porous conductive element.

Abstract: A medical lead having a rotatable helical tip electrode helix and a retraction stop mechanism for preventing over-retraction of the helical tip electrode during lead repositioning. The retraction stop mechanism includes an engaging member positioned along a drive shaft of the lead and having a front surface, a flange portion extending along the front surface of the engaging member, and a retraction flange. Rotation of the drive shaft causes the flange portion to engage the retraction flange so that rotation of the drive shaft is absorbed by the conductor.

Abstract: A lead adapted to be located within the cardiac vasculature is disclosed. The lead may be readily steered to a desired location within the cardiac vasculature to thereafter be securely located at a desired pacing site. The lead is provided with an improved electrode assembly located at its distal tip. The electrode assembly includes a fixation helix and a guidewire-like projection, both extending from the distal end of the lead body. The fixation helix, which may serve as all or part of the active electrode surrounds a structure corresponding to the distal end of a conventional guidewire. The fixation helix is mounted around the guidewire tip so that the sharpened tip of the helix lies closely adjacent to the guidewire tip, in a region of the guidewire tip which is sufficiently flexible to allow it to be moved away from the sharpened tip of the helix.

Abstract: Catheter systems and methods for implanting helical or dart-like implants into the myocardium or other body tissue. The catheter system includes a helix for fixing the distal end of the catheter to the myocardium, an implant held by the helix, mechanisms for driving the fixation helix into the myocardium, and mechanisms for driving the implant into the myocardium, removing the fixation helix and leaving the implant behind. The implant may be coated, filled, or made of a drug or drug eluting compound, or drug delivery matrix of any composition.

Abstract: A transvenous implantable medical device adapted for implantation in a body, and which is particularly adapted for use in a vessel such as the coronary sinus or cardiac great vein. The implantable medical device may take the form of a lead or catheter, and includes an extendable distal fixation member such as a helix. In one embodiment, the fixation member is a helix constructed of a shape memory metal or other super-elastic material. Upon deployment, the helix assumes a predetermined helix shape larger than the diameter of the lead body diameter. The helix functions to wedge or fix the lead within the vessel in a manner that does not impede the flow of blood through the vessel. The helix may be retracted for ease of repositioning and/or removal. In one embodiment of the invention, the fixation member may be advanced using a stiffening member such as a stylet. In another embodiment, the helix is coupled to a coiled conductor such that rotation of the conductor extends or retracts the helix.

Abstract: A helical element for insertion into tissue comprises a helical element having an insertion end, a protruding end and an open central area within the wire, rods, filaments, cables or the like that form the helix. The helical element has at least its insertion end covered by a cap of a water-soluble or water-dispersible composition. The cap is provided with a surface shape in a cross-section in which surface variations are present in the cross-section which create a surface orientation where a line from the center of the cross-section can intersect the surface, and a line perpendicular to said radius at a point of intersection with said surface forms four quadrants, three of said quadrants containing water-soluble or water-dispersible cap material. There is either a hollow area within the composition within the open central area or the material is more porous than the remaining material.

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: The present invention provides an ablation lead for treating atrial flutter wherein the tip of the lead is fixed in the patient's heart by screwing and wherein the electrodes are arranged on the lead so as to overlie the area between the tricuspid annulus and the inferior vena cava. Radiofrequency energy is applied through the electrodes to cause ablation of the tissue. With the tips screwed in position, the lead can then be manipulated so that the RF energy can be applied to the area between the coronary sinus the tricuspid annulus to cause ablation of the tissue in that area also.

Abstract: A cardiac stimulator lead is provided that includes a two-stage extendable/retractable fixation. A cardiac stimulator lead comprises a connector for connecting to a cardiac stimulator, a tubular insulating sleeve having a first end coupled to the connector and a second end, and an electrode coupled to the second end and having a longitudinal bore. An extendable/retractable corkscrew is positioned in the bore. In one aspect, the bore is configured so that the corkscrew will not extend fully unless tissue is present to engage the corkscrew.