Abstract: There is provided an implantable system and method for delivering stimulus pulses and/or collecting data from a plurality of sites within a patient's body, having a main controller device with a power source, a stimulator/sensing devices at each of said sites, and circuitry for high frequency transmission of power from the main unit to each of the remote devices. Power is transferred by converting it into a high frequency at the controller unit, and periodically or on request transmitting it to the respective devices. The main controller unit and each respective device also preferably has one or more sensors for collecting data and processor circuitry for analyzing such data. Each remote device has a transmitter for transmitting collected data back to the main controller; the main controller has encoding circuitry for encoding a data component onto the high frequency carrier along with the power component.

Abstract: A body-implantable transvenous endocardial lead for an implantable medical device system. The lead includes inner and outer coiled conductors each surrounded by a flexible elongate sheath such that the inner conductor is rotatable within the outer sheath. An electrode assembly disposed at the distal end of the lead includes a distally-projecting fixation helix. A sliding member in the electrode assembly includes a helix-engaging collar for engaging the coils of the fixation helix, such that when the helix is rotated in a first direction with respect to the sliding member, it is advanced in a screw-like fashion distally forward with respect to the sliding member, and when the helix is rotated in a second direction with respect to the sliding member, it is retracted proximally backward with respect to the sliding member. A tip electrode is disposed on the distal end of the sliding member.

Abstract: A medical electrical lead system having a torque transfer stylet. In a preferred embodiment, the torque transfer stylet comprises an elongated, stylet wire having proximal, intermediate and distal sections. The proximal and distal section of the stylet wire have a first diameter. The intermediate section spans between the proximal and distal sections. The stylet wire in this region, however, has a second diameter, the second diameter smaller than the first diameter of the proximal and distal sections. In addition, the intermediate section further has a length of torque coil wrapped thereabout. The torque coil preferably is wound in a coiled diameter which is the same as the first diameter of the proximal and distal sections of the stylet wire. Through such a configuration the stylet has an overall nearly uniformed diameter through its length.

Abstract: A chronic myocardial pacing lead for the delivery of stimulation energy to and the sensing of electrical signals from the myocardium of a human heart. In one embodiment the lead is bipolar, having a sleeve electrode implanted into the myocardium and a pad electrode positioned on the epicardium. The lead includes a drug for delivery through the sleeve electrode to the myocardium. The disclosed lead is highly flexible to minimize tissue reaction, this permits the lead to offer relatively low pacing thresholds, high impedance, and excellent sensing in a configuration which is relatively easy to implant.

Abstract: An implantable lead for establishing electrical contact between a medical device and body tissue, in which an active fixation mechanism secures the lead in place while allowing a distal electrode on the lead to mechanically "float" with respect to the body tissue. In one embodiment, the active fixation mechanism comprises a curved hook disposed on the lead at a point spaced proximally back from the distal end of the lead. The curved hook defines a helix around at least a portion of the lead's circumference. A hollow introducer needle is slidably disposed on the lead. The hollow needle provided with a longitudinal slit in a distal section of is length, such that the distal section of the needle can be advanced over the distal end of the lead, past the fixation hook, which is received in the longitudinal slit. With the needle slid over the distal end of the lead, the needle is stabbed tangentially into an implant site, bringing the fixation hook proximal to the surface of the body tissue.

Abstract: A lead connection suitable for use in connecting a flexible coiled lead to an implantable device. The implantable device is provided with a threaded projection having an outer diameter sized with respect to the inner diameter of the lead's conductor coil to provide a secure interconnection therewith when attached thereto. The threaded projection is disposed on top and around a feedthrough pin projecting out of the implanted device's hermetic canister. The threaded projection is screwed into the conductor coil establishing sound electrical contact between the projection and the conductor. A strain relief collar surrounds the post and lead, and a twist-and-pull type connecting ring surrounds the base of the strain relief collar. The connecting post is prevented from being unscrewed from the conductor coil, since an unscrewing motion tends to tighten the conductor coil around the threaded post.

Abstract: A medical electrical lead of the type which includes an electrode at a distal end of the lead a connector at a proximal end of the lead and an elongated electrical conductor extending between the electrode and the connector. The conductor is comprised of a wire wound in a coil configuration with the wire comprised of a duplex titanium alloy. Materials of such composition have been found to have suitable conductivity for use with implantable pulse generators and suitable fatigue strength when used in endocardial lead placement. Moreover, such materials have been found to pass tests intended to detect metal ion oxidation (MIO) in susceptible polymeric materials.

Abstract: A steerable stylet and manipulative handle assembly for guiding a lead or a catheter to a desired location in a patient. The steerable stylet comprises an outer, elongated tubular member of a length sufficient to extend through the length of the lead or catheter from its proximal opening to the distal end thereof, a traction element or pull wire extending generally through the length of the tubular member and within its lumen except for a span in the distal portion thereof, and a manipulative handle coupled to the proximal ends of the tubular member and wire. Traction applied with one hand to the pull wire via the handle causes the distal portion of the tubular member to bend. Distal portion of the tubular member is provided with openings to allow the wire to exit and re-enter the lumen and facilitate bending of the tubular member. Distal portion of the tubular member which bends is preferably deformed, such as cut out or flattened or indented, to avoid kinking.

Abstract: A lead connection suitable for use in connecting a flexible coiled lead to an implantable device. The implantable device is provided with a threaded projection having an outer diameter sized with respect to the inner diameter of the lead's conductor coil to provide a secure interconnection therewith when attached thereto. The threaded projection is disposed on top and around a feedthrough pin projecting out of the implanted device's hermetic canister. The threaded projection is screwed into the conductor coil establishing sound electrical contact between the projection and the conductor. A strain relief collar surrounds the post and lead, and a twist-and-pull type connecting ring surrounds the base of the strain relief collar. The connecting post is prevented from being unscrewed from the conductor coil, since an unscrewing motion tends to tighten the conductor coil around the threaded post.

Abstract: A myocardial pacing lead includes two sets of at least two tines placed to oppose each other. The lead is pressed against the epicardium and is rotated until a rough porous tip abrades the epicardium and allows the tip and the first row of tines to penetrate the myocardium. Excessive penetration and lead migration is prevented by the second row of tines which is mounted backward and just proximal from the first row of tines. The first row of tines anchor on the inside surface of the epicardium which prevents dislodgment. Dacron pads on the second row of tines assures chronic fixation by adhering to the outer surface of the patient's epicardium.

Abstract: A small diameter, unipolar or bipolar, atrial or ventricular transvenous or epimyocardial pacing lead with a porous, platinized, steroid eluting cathode electrode exhibiting an effective surface area in the range of 0.1 to 4.0 mm.sup.2, preferably 0.6 to 3.0 mm.sup.2, provides low stimulation thresholds in the range of 0.5 volts, 0.5 milliseconds, very high pacing impedance (800 to 2,000 .OMEGA.), relatively low polarization, good to excellent sensing, and adequately low source impedance. The high pacing impedance prolongs the longevity of pacing pulse generators and allows for the miniaturization of their components. The low thresholds allow large safety factors at low applied voltages, which also contribute to increased battery longevity.

Abstract: A cardiac pacing lead or other stimulation lead carrying a drug compounded into a matrix, located within the distal portion of the lead. The drug is delivered to the tissue adjacent the distal end of the lead. In connection with the polymer matrix, the lead is provided with a penetrating electrode, which takes the form of a sharpened helix. The electrode is provided with a groove, running the length of the electrode and exposed to the matrix. In use, the drug elutes out of the matrix, through the groove in the electrode, and into the tissue to be stimulated. The drug may be an antiinflammatory agent, such as a glucocorticosteroid, to minimize the effects of implantation of the electrode into the tissue to be stimulated.

Abstract: A cardiac pacing lead or other stimulation lead carrying a steroid compounded within a polymer matrix. The steroid is dispersed in thermoplastic or thermoset polyurethane or polyurea forming monomers or prepolymers. The mixture is then chain extended by addition of the appropriate difunctional or multifunctional isocyanate, hydroxyl or amine curing agent to form a solid polymer. The resulting formulation is molded or cast into a desired shape, and incorporated in the distal end of a medical electrical lead, adjacent to or within the electrode. In a preferred embodiment, the medical lead employs an extendable helix which is screwed into body tissue, and the polymer containing the drug takes the form of a generally dimensionally stable annular member mounted to the lead, encircling the helix.

Abstract: A body implantable lead for the delivery of stimulation energy to a desired body site including a drug dispenser carried by the lead which retains a drug to be dispensed while allowing a dispensing of that drug at least adjacent the desired body stimulation site. The drug may be one which is intended to counter thrombus formation, fibrosis, inflammation or arrhythmias, or any combination thereof, or to accomplish any other localized purpose. The drug may be in liquid form retained in a reservoir carried by the lead with an agency controlling dispensing of the drug. The controlling agency may be a semi-permeable membrane. Alternatively, the reservoir may be formed as an osmotic pump. As a further alternative, the drug may be retained as a coating on a large surface area portion of the lead, or an electrode carried by the lead.

Abstract: A single-pass body implantable lead for transvenous insertion through a single vein to simultaneously sense and/or stimulate the tissue of both the right atrium and right ventricle. The lead employs a single bifurcated connector at the proximal end. Insulated conductors for the ventricle and atrium are branched from a single outer sheath. The ventricular and atrial branches are established in fixed relation to one another. The ventricular branch is of sufficient length that it has excess length for the largest heart. The electrode of the ventricular branch is held within the right ventricular apex by tines. The atrial branch has a "J" shape imparted to the conductor coil. The atrial electrode is maintained in position within the right atrial appendage by tines. The ventricular branch is sufficiently flexible such that any excess length is merely coiled in some convenient position.

Abstract: A body implantable lead for the delivery of stimulation energy to a desired body site including a drug dispenser carried by the lead which retains a drug to be dispensed while allowing the dispensing of that drug at least adjacent the desired body stimulation site. The drug is retained in a cavity within the lead, in the form of a solid plug or a powder wherein the drug is compounded with an appropriate molecular sieve material. The drug is released only after the molecular sieves are activated by exposure to water. In those embodiments in which the molecular sieves take the form of a powder, the molecular sieves and drug may be conveniently loaded into the electrode, after manufacture and prior to implant.

Abstract: A body implantable lead for the delivery of stimulation energy to a desired body site including a drug dispenser carried by the lead which retains a drug to be dispensed while allowing the dispensing of that drug at least adjacent the desired body stimulation site. The drug may be one which is intended to counter thrombus formation, fibrosis, inflammation or arrhythmias, or any combination thereof, or to accomplish any other localized purpose. The drug is retained in a cavity within the lead, with an agency controlling dispensing of the drug. In a preferred embodiment, the drug is compounded into a solid material which is retained within a tip electrode while being exposed to body fluids through a porous elution path. The drug may also be retained on and diffused from a porous surface of the electrode, adjacent to the elution path. Preferably, the drug is compounded within a polymer carrier, mounted within the cavity in the electrode.

Abstract: A dual chamber pacing lead requiring but a single transvenous pass for implantation. The ventricular electrode has tines for sustaining acute and chronic fixation. The ventricular electrode is coupled to a first conductor which is space wound having an insulation sheath. The proximal end of the first space wound coil protrudes slideably from a first connector pin of a bifurcated connector assembly. An optional stylet may be inserted into the first space wound coil to assist in ventricular placement. A second space wound coil is slideably located over the first space wound coil. The second space wound coil serves as a support means rather than a conductor. The proximal end of the second space wound coil is fixedly attached to the connector assembly. The first space wound coil protrudes near the distal end of the second space wound coil.

Abstract: An epicardial pacing lead for the delivery of stimulation energy to and the sensing of electrical signals from the myocardium of a human heart. The lead includes an electrode which penetrates the myocardium and serves to anchor the lead to the heart. The lead contains a drug for delivery through the electrode, to the myocardium. The electrode is provided with a bore for passage of the drug to the stimulation and fixation site.

Abstract: A sleeve or collar for preventing the migration of infection along the length of an implanted lead. The sleeve or collar is given anti-microbial properties, as by embedding therein or coating with anti-microbial substance. At the time that a changeable portion of an implantable device is changed-out, e.g., when the pulse generator in a pacemaker system must be replaced due to battery depletion, the collar or sleeve in accordance with the present invention is affixed to the lead and slid as far distal along the lead as possible, in order to ensure that a barrier is established to prevent the migration of infection to the extreme distal end of the lead. In one embodiment of the invention, the collar or sleeve can serve the dual purposes of establishing an infection barrier and of facilitating the anchoring of the lead in place.