Abstract: The present invention provides diverse methods and apparatus for in vivo monitoring, detecting and/or predicting potential failure modes or deleterious trends of chronically implanted medical electrical leads prior to actual failure of said leads. Certain embodiments of the invention involve applying a relatively increased data sampling rate at various time intervals (e.g., periodically, randomly, and/or manually-triggered and the like) prior to actual detection of a deleterious trend, to thereby increase the probability of detecting one or more parameters indicative of a potential lead performance issue. At least some of the parameters are utilized because they are not typically reliably detected at relatively lower data sampling rates.

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: 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: An implantable electrical medical device and method for manufacturing the same are provided. The method includes forming a conductive substrate, placing the conductive substrate in a deposition chamber; and forming a conformal coating over the conductive substrate using atomic layer deposition. In various embodiments, the conformal coating is a conductive coating and in other embodiments the conformal coating is a dielectric coating.

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: An implantable medical device, perhaps a pacemaker lead, has a medical unit and a casing at least partially enclosing the medical unit. The casing is formed of a base polymer having surface modifying pendant groups formed of an acrylamide polymer or an acrylamide copolymer, perhaps polyisopropyl acrylamide. The base polymer may be a polyurethane, polyimide, fluoropolymer or polyolefin, for example.

Abstract: A system for monitoring trends in lead impedance includes collecting data from various sources in an implantable medical device system. Lead impedance, non-physiologic sensed events percentage of time in mode switch, results of capture management operation, sensed events, adversion pace counts, refractory sense counts and similar data are used to determine the status of a lead. A set of weighted sum rules are implemented by a software system to process the data and provide displayable information to health care professionals via a programmer. The lead monitoring system includes a patient alert system for patients to seek help in the event a serious lead condition is identified.

Abstract: A system for monitoring trends in lead impedance includes collecting data from various sources in an implantable medical device system. Lead impedance, non-physiologic sensed events percentage of time in mode switch, results of capture management operation, sensed events, adversion pace counts, refractory sense counts and similar data are used to determine the status of a lead. A set of weighted sum rules are implemented by a software system to process the data and provide displayable information to health care professionals via a programmer. The lead monitoring system includes a patient alert system for patients to seek help in the event a serious lead condition is identified.

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 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: An implantable medical device, perhaps a pacemaker lead, has a medical unit and a casing at least partially enclosing the medical unit. The casing is formed of a base polymer having surface modifying pendant groups formed of an acrylamide polymer or an acrylamide copolymer, perhaps polyisopropyl acrylamide. The base polymer may be a polyurethane, polyimide, fluoropolymer or polyolefin, for example.

Abstract: A system for monitoring trends in lead impedance includes collecting data from various sources in an implantable medical device system. Lead impedance, non-physiologic sensed events percentage of time in mode switch, results of capture management operation, sensed events, adversion pace counts, refractory sense counts and similar data are used to determine the status of a lead. A set of weighted sum rules are implemented by a software system to process the data and provide displayable information to health care professionals via a programmer. The lead monitoring system includes a patient alert system for patients to seek help in the event a serious lead condition is identified.

Abstract: An implantable medical device (IMD) coupled with leads extending to body tissue providing storage of lead related data, monitoring of lead functional status, and indication of lead integrity to the clinician. A lead status monitor (LSM) processes lead related data in a system self test mode and provides a lead status report that identifies and declares conductor/connector issues, insulation issues, and electrode/tissue interface issues indicative of suspected lead related condition mechanisms for each lead employed in the IMD. The LSM operates employing a set of LSM rules that process measured lead impedance values and loss of capture (LOC) values. In a pacing system, particular LSM rules are defined that process periodically determined, pacing pulse characteristic at LOC and bipolar and unipolar lead impedance values that are measured periodically. The lead impedance values are compared to upper and lower limits or trip points of a normal impedance range.

Abstract: A cardiac pacing lead for use in the coronary sinus and coronary veins. The lead is provided with a lead body configured to exhibit a curved configuration along a distal portion thereof, induced to maintain a portion of the curved configuration solely by means of a portion of a polyurethane lead body formed to display the curved configuration and wherein the lead conductor is freely mounted within the segment. The curved configuration includes first and second arcuate segments together providing a single-plane curvature of approximately 180 degrees, separated by a generally straight segment, the first segment having a greater length and greater arc of curvature than the second segment.

Abstract: A cardiac pacing lead for use in the coronary sinus and coronary veins. The lead is provided with a lead body configured to exhibit a curved configuration along a distal portion thereof, induced to maintain a portion of the curved configuration solely by a portion of a polyurethane lead body formed to display the curved configuration and wherein the lead conductor is freely mounted within the segment The curved configuration includes first and second arcuate segments together providing a single-plane curvature of approximately 180 degrees, separated by a generally straight segment, the first segment having a greater length and greater arc of curvature than the second segment.

Abstract: A cardiac pacing lead and a method of its use. The lead has an elongated insulative lead body having a distal section formed into a curved configuration appropriate for use in a coronary sinus/cardiac vein of a patient's heart. An active fixation device is located proximal to the distal, curved section of the lead body, which carries an electrode, located along the distal portion of the lead body, spaced from the active fixation device a distance appropriate to locate the electrode adjacent the left atrium or left ventricle of a human heart when the fixation device is located adjacent the ostium of the coronary sinus. The lead is used by advancing the distal portion of the lead through the coronary ostium of the patient's heart and into the coronary sinus/cardiac vein and therefter employing the active fixation device to affix the lead to the patients heart outside of the coronary sinus/cardiac vein.

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 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.