Abstract: Medical electrical leads adapted to be implanted within the body, and particularly such leads having at least one distal electrode affixed at a site of a body organ, particularly the epicardium of the heart, employing a light-activated adhesive fixation, and methods and systems for accessing the site, applying the distal electrode to the site, and activating the light-activated adhesive. The lead is preferably implanted by performing a thoracoscopy of the thorax of the patient to visualize the site of the epicardium through a thoracoscope and to provide a pathway to the site of the epicardium. While viewing the site of the epicardium through the thoracoscope, the electrode head is inserted through the provided pathway to apply the plate against the site of the epicardium, and the light-activated adhesive is exposed to a predetermined bandwidth of light to adhere the plate to the epicardium.

Abstract: An electrical connector has a compressible portion that expands to accept an inserted lead and then contracts around the lead to provide both an electrical and a spring-like mechanical connection to the lead. The connector may have a fluted pin that collapses around the lead body when a set screw of the connector port is tightened. Alternatively, a middle segment of a pin may have indentations or slots that collapse around an inserted lead body. The connector can be attached to the lead body after the lead body is implanted in the body of the patient. In lead systems in which the lead body is implanted using a guide catheter, attaching the connector to the lead body after implantation makes removal of the guide catheter much less difficult.

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 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/fiber assembly extending within the insulative sheath. The coil/core assembly 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 assembly 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: The present invention discloses use of a “Z-shaped” configuration for a pair of internal windings of a fiber core of a medical electrical lead. As illustrated and described, these Z-shaped braids, or windings, are a primary source of counter-rotation for an electrode coupled to cardiac tissue during extraction of the lead with axial tension, or traction. When fully assembled and implanted within a patient, an electrode, such as a helical electrode, is electrically coupled to a coil conductor and mechanically coupled to a loop formed at an end of the Z-shaped braided fiber. To remove the lead, a traction force is applied to the lead and as the Z-shaped braids begin to unwind rotational force is applied to unscrew the helical electrode. A lead constructed according to the present invention is isodiametric, has an outer diameter of less than about 4 French, and rotates counterclockwise in response to tensile force.

Abstract: A deflectable tip introducer or guide catheter optimized for placement of leads or catheters within the vasculature of the human body is disclosed. The introducer includes inner and outer concentrically located tubular sheaths. The inner and outer sheaths are preferably provided with different curved configurations, allowing the over-all displayed curvature of the introducer over its distal portion to be adjusted by longitudinal movement of the inner and outer sheaths relative to one another. The outer sheath may be fabricated of a thin tube of polyetheretherketone (PEEK) or other material having a relatively large stiffness as compared to the inner sheath. The outer sheath is sized to fit closely around the inner sheath. The inner sheath may be formed of a reinforced polyurethane, and preferably has a thin wall that is of about 0.005 inches in thickness or less.

Abstract: A medical positioning device internal to a catheter or lead for the nonlinear insertion of a catheter or lead into an interior organ. The medical positioning device comprising an outer tubular member, a superelastic inner tubular member having a curvature positioned within the outer tubular member, and an innermost member positioned within the inner tubular member. The superelastic inner tubular member straightens when placed substantially within the outer tubular member and the inner tubular member resumes its original curvature and moves along a curvilinear trajectory when advanced outwardly from the outer tubular member. Insertion of the outer tubular member into the body, advancement of the inner tubular member into an interior organ, and advancement of the innermost member guides and positions a catheter or lead into an interior organ and to a treatment site along a nonlinear insertion path.

Abstract: An atrial lead system and a method of employing it to provide single electrode bi-atrial pacing. The system includes an atrial pacing lead having electrode located on a distal portion thereof and a guide catheter having a longitudinal lumen and a lateral aperture open to the longitudinal lumen of the catheter proximal to a distal end of the catheter through which the distal portion of the lead may be advanced. The electrode is preferably an active fixation electrode or is associated with an active fixation device. The system is employed by first advancing the guide catheter to the ostium of a patient's coronary sinus and inserting the distal end of the guide catheter into the coronary sinus such that the lateral aperture of the catheter is located in the patient's right atrium. The atrial pacing lead is then advanced through the lumen of the guide catheter such that the electrode exits the lateral aperture of the guide catheter and the electrode is affixed to the tissue of the atrial septum.

Abstract: A medical positioning device internal to a catheter or lead for the nonlinear insertion of a catheter or lead into an interior organ. The medical positioning device comprising an outer tubular member, a superelastic inner tubular member having a curvature positioned within the outer tubular member, and an innermost member positioned within the inner tubular member. The superelastic inner tubular member straightens when placed substantially within the outer tubular member and the inner tubular member resumes its original curvature and moves along a curvilinear trajectory when advanced outwardly from the outer tubular member. Insertion of the outer tubular member into the body, advancement of the inner tubular member into an interior organ, and advancement of the innermost member guides and positions a catheter or lead into an interior organ and to a treatment site along a nonlinear insertion path.

Abstract: A lead and a lead system for dispersion of a cardioversion/defibrillation electrode formed of one or more small diameter defibrillation electrodes in a heart chamber and for attaching a pace/sense electrode in contact with the heart. The small diameter defibrillation electrode or electrodes extend distally from the distal end of the lead body. If multiple electrodes are employed, they are preferably biased to spread apart when unrestrained and have a cross-section size small enough to be inserted into interstices of trabeculae in the ventricular chamber. The distal ends of the defibrillation electrodes may be free of attachment to the lead body or may be attached by a weak bond to the distal portion of the lead.

Abstract: A lead and a lead system for dispersion of a cardioversion/defibrillation electrode formed of one or more small diameter defibrillation electrodes in a heart chamber and for attaching a pace/sense electrode in contact with the heart. The small diameter defibrillation electrode or electrodes extend distally from the distal end of the lead body. If multiple electrodes are employed, they are preferably biased to spread apart when unrestrained and have a cross-section size small enough to be inserted into interstices of trabeculae in the ventricular chamber. The distal ends of the defibrillation electrodes may be free of attachment to the lead body or may be attached by a weak bond to the distal portion of the lead.

Abstract: An atrial lead system and a method of employing it to provide a single electrode bi-atrial pacing. The system includes an atrial pacing lead having an electrode located on a distal portion thereof and a guide catheter having a longitudinal lumen and a lateral aperture open to the longitudinal lumen of the catheter proximal to a distal end of the catheter through which the distal portion of the lead may be advanced. The electrode is preferably an active fixation electrode or is associated with an active fixation device. The system is employed by first advancing the guide catheter to the ostium of a patient's coronary sinus and inserting the distal end of the guide catheter into the coronary sinus such that the lateral aperture of the catheter is located in the patient's right atrium. The atrial pacing lead is then advanced through the lumen of the guide catheter such that the electrode exits the lateral aperture of the guide catheter and the electrode is affixed to the tissue of the atrial septum.

Abstract: A medical electrical lead having a drug which is no more than sparingly soluble in water applied to the electrode surface. In the preferred embodiment the lead of the present invention possesses an electrode treated with a very slightly soluble in water steroid, such as beclomethasone dipropionate anhydrous. Preferably the steroid is applied to the surface of the electrode which contacts tissue when implanted. A method of manufacturing such a lead is also disclosed. Through such a design, a high impedance, low threshold lead which is simple and easy to manufacture is disclosed.

Abstract: An implantable electrical lead having a lead body fabricated of a first, inner tube and a second, outer tube, the first, inner tube, mounted slideably within the outer tube, the outer tube overlapping the inner tube along at least a portion of its length; and having a conductor extendible along a portion of its length, mounted within and extending along the first and second tubes with the extendible portion of the conductor extending within a region in which the outer tube overlaps the inner tube and having an electrode mounted to a distal portion of the lead body, coupled to the conductor. The inner and outer tubes are preferably approximately the same length, and the extendible portion of the conductor preferably extends along a majority of its length. The extendible conductor may be a coiled conductor provided with an insulative coating.

Abstract: A lead and a lead system for dispersion of a cardioversion/defibrillation electrode formed of one or more small diameter defibrillation electrodes in a heart chamber and for attaching a pace/sense electrode in contact with the heart. The small diameter defibrillation electrode or electrodes extend distally from the distal end of the lead body. If multiple electrodes are employed, they are preferably biased to spread apart when unrestrained and have a cross-section size small enough to be inserted into interstices of trabeculae in the ventricular chamber. The distal ends of the defibrillation electrodes may be free of attachment to the lead body or may be attached by a weak bond to the distal portion of the lead.

Abstract: A novel low cost, temporary pacing lead that provides superior torque transfer characteristics and positive affixation to the endocardial wall. The lead system of the present invention provides up to ten times more torque transmission between its proximal and distal ends than may be attained using prior art temporary leads. Additionally, the lead body of the present invention has a ratio of ring electrode surface area to tip electrode surface area that exceeds about 2, and a tip electrode surface area less than or equal to 10 millimeters squared.

Abstract: A physiologic rate responsive pacer which alters the pacer's escape interval in response to the patient's respiratory minute ventilation derived from the electromyogram of selected respiratory muscle groups. The directly detected electromyogram (EMG) signal is amplified and band passed filtered, processed to remove any electrocardiogram (ECG) or pacing impulse signal, full-wave rectified, processed to develop a moving time average signal from which the peak, the maximal slope, and the average slope of the EMG moving time average may be calculated and processed in conjunction with the inspiratory and expiratory times between successive slope detections of the moving time average EMG to develop a rate control signal representative of minute ventilation.

Abstract: A medical electrical lead having a fixation helix which is surface treated along at least a portion to have a relatively high microscopic area along with a relatively low macroscopic area. In the preferred embodiment, such a surface treated portion is accomplished with a porous platinized construction. The surface treated portion further has a bioabsorbable coating in order to permit the helix to be inserted into the heart tissue without causing damage to the heart tissue through the engagement of the surface treated portion with heart tissue during insertion. In the preferred embodiment the bioabsorbable material is mannitol, although other bioabsorbable materials may also be used, such as a material which is no more than sparingly soluble in water, for example, the steroid beclomethasone dipropionate anhydrous. Through such a construction the helix may be inserted into tissue while the coating of absorbable materials provides a smooth surface between the surface treated portion of the helix and the tissue.

Abstract: A lead extraction device synchronized to the cardiac cycle which utilizes laser light to separate an implanted object, such as a pacemaker lead, from fibrous scar tissue and thereby permit the implanted object to be extracted from a body. The extraction device features a catheter having a central lumen dimensioned so a pacemaker lead will fit within. The catheter is thereby guided by the lead. The catheter has at least one optical fiber to emit laser light from the distal end and thereby separate the lead from fibrous scar tissue. A means for generating a control pulse in response to a sensed ECG signal permits the catheter to by synchronized to the cardiac cycle. In such a manner laser light may be controlled so as to avoid striking the heart at a vulnerable period in the cardiac cycle.

Abstract: A physiologic rate responsive pacer which alters the pacer's escape interval in response to the patient's respiratory minute ventilation derived from the electromyogram of selected respiratory muscle groups. The directly detected electromyogram (EMG) signal is amplified and band passed filtered, processed to remove any electrocardiogram (ECG) or pacing impulse signal, full-wave rectified, processed to develop a moving time average signal from which the peak, the maximal slope, and the average slope of the EMG moving time average may be calculated and processed in conjunction with the inspiratory and expiratory times between successive slope detections of the moving time average EMG to develop a rate control signal representative of minute ventilation.