Abstract: In one embodiment, a neurostimulation lead, comprises: a lead body, the lead body comprising an inner insulator, an outer insulator positioned around the inner insulator, wherein the outer insulator and the inner insulator are fused together; at least one conductor that is wound between the inner insulator and the outer insulator; and at least one electrode that is electrically coupled to the at least one conductor.

Abstract: A lead body and method for lead body manufacture are provided having at least one conductor positioned between an inner insulator and an outer insulator wherein the outer insulator is fused to the inner insulator by heating. Further, an insulating spacer may be provided between the conductors that may be fused to either or both of the outer insulator and the inner insulator.

Abstract: The present invention provides a medical lead for implantation within a patient. The medical lead has a seem-less lead body having one or more electrodes secured to the distal end and one or more connector bands attached to the proximal end of the lead.

Abstract: Instruments and methods for insertion of one or more spinal implants into an intervertebral space between opposing vertebral bodies are disclosed. Instruments according to the invention include a guide for preparing a spinal fusion implant site, a guide starter, implant depth gauges, reamers, taps and implant drivers. The instruments and methods disclosed provide improved visualization of the surgical field and enhanced precision of placement of spinal fusion implants between vertebral bodies.

Abstract: Instruments and methods for insertion of one or more spinal implants into an intervertebral space between opposing vertebral bodies are disclosed. Instruments according to the invention include a guide for preparing a spinal fusion implant site, a guide starter, implant depth gauges, reamers, taps and implant drivers. The instruments and methods disclosed provide improved visualization of the surgical field and enhanced precision of placement of spinal fusion implants between vertebral bodies.

Abstract: An apparatus is provided for use in stimulating a body tissue or organ that has a flexible band electrode. The band electrode includes at least one slot configured to provide increased flexibility. A lead having the electrode is also provided as well as a method for manufacturing a band electrode having at least one slot.

Abstract: A lead body and method for lead body manufacture are provided having at least one conductor positioned between an inner insulator and an outer insulator wherein the outer insulator is fused to the inner insulator by heating. Further, an insulating spacer may be provided between the conductors that may be fused to either or both of the outer insulator and the inner insulator.

Abstract: The present invention provides a medical lead for implantation within a patient. The medical lead has a seem-less lead body having one or more electrodes secured to the distal end and one or more connector bands attached to the proximal end of the lead.

Abstract: An introducer system for a lead, catheter, probe or the like, employing a dilator and introducer sheath assembly for dilating a body vessel in preparation for introducing the lead, etc., through the lumen of the introducer sheath that provides for the injection of radiopaque contrast media to observe the cause of an impediment to advancement of the assembly into the vessel lumen. The dilator is formed of an elongated dilator body having a guide wire lumen therein for receiving and being advanced over the guide wire and a hub assembly at the proximal end of the guide wire body. An injection lumen is also formed in the dilator body isolated from the guide wire lumen and in fluid communication with a side port formed in the hub assembly and an injection port formed in the distal end of the dilator body. Preferably, the injection port is formed in a tapered distal end portion of the dilator.

Abstract: An implantable device for affixing to the anterior side of cervical vertebrae for stabilizing the cervical vertebral column. A plate has an anterior surface and a posterior surface and a plurality of through holes open at the anterior surface and at the posterior surface. Each hole has an anterior portion having a first diameter and a posterior portion having a second diameter. The second diameter is smaller than the first diameter, and the anterior portion of the hole is internally threaded. A bone screw has a threaded shank having a major diameter smaller than the second diameter of the through hole of the plate. The bone screw also has a head having a major diameter greater than the second diameter of the through hole of the plate and smaller than the first diameter of the hole of the plate. A locking cap has an exterior thread and is sized to be threadedly received within the anterior portion of the through hole of the plate while the head of the bone screw is disposed within the through hole.

Abstract: A steerable stylet and manipulative handle assembly especially adapted for guiding the introduction of an endocardial pacing or cardioversion/defibrillation lead or a catheter to a desired location in a patient's cardiovascular system. The steerable stylet or catheter designed to be introduced into the lumen of a lead 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 predetermined distance in the distal portion thereof, and a manipulative handle coupled to the proximal ends of the tubular member and wire which may be employed with one hand to both rotate the tubular member and impart a continuously variable curve in the distal portion thereof.

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 suture sleeve for facilitating the ligature of an implanted catheter or lead to a patient's vein or underlying tissue having a longitudinal sleeve throughbore for receiving the lead body extending through a sleeve body and a movable locking member manually actuable between a locked and an unlocked position. The throughbore of the movable locking member is aligned with throughbores of the sleeve body, and the movable locking member and transverse channel are shaped to bias the movable locking member to the unlocked position. The locking member is movable laterally in a locking direction in a transverse channel extending laterally across the sleeve body with respect to the sleeve throughbore to a locked position that diminishes the movable locking member throughbore thereby compressing the lead body and applying a relatively uniform pressure in a band extending around its circumference, thereby minimizing lead body shear stresses.

Abstract: A steerable stylet and manipulative handle assembly especially adapted for guiding the introduction of an endocardial pacing or cardioversion/defibrillation lead or a catheter to a desired location in a patient's cardiovascular system. The steerable stylet or catheter designed to be introduced into the lumen of a lead 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 predetermined distance in the distal portion thereof, and a manipulative handle coupled to the proximal ends of the tubular member and wire which may be employed with one hand to both rotate the tubular member and impart a continuously variable curve in the distal portion thereof.

Abstract: A transvenous lead introducer having an integral mechanical valve assembly which includes opposed comating valve members that are operated by opposed handles. The handles and the valves are joined by rotatable link assemblies and are normally biased in a closed position by integrally formed bias springs.

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: A transvenous lead introducer having a mechanical valve assembly disposed thereon. In a preferred embodiment, a longitudinally splittable introducer sheath is provided with a sliding valve at or near one end. The sliding valve may be spring-biased to a normally closed position. A semicircular notch may be provided in the forward end of the sliding valve, so that the sheath may be effectively sealed even when a guide wire runs through the sheath. In an alternative embodiment, the sliding valve is adapted to have its forward end inserted into a notch in the cylindrical sheath body. The mechanical valve assembly is further configured to permit use with a splittable lead introducer sheath.

Abstract: A steerable stylet and manipulative handle assembly especially adapted for guiding the introduction of an endocardial pacing or cardioversion/defibrillation lead or a catheter to a desired location in a patient's cardiovascular system. The steerable stylet or catheter designed to be introduced into the lumen of a lead 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 predetermined distance in the distal portion thereof, and a manipulative handle coupled to the proximal ends of the tubular member and wire which may be employed with one hand to both rotate the tubular member and impart a continuously variable curve in the distal portion thereof.

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: An implantable lead having a plastic stylet guide therein. A substantially cylindrical channel is provided in a flexible lead body made of silicone rubber, polyurethane, or the like. The cylindrical channel defines a lumen containing a stylet guide into which a stylet can be inserted during an implantation procedure. Texture on the inner wall of the stylet guide minimizes friction between the stylet and the stylet guide, facilitating easy insertion and removal of the stylet. One or more electrical conductors may also be provided.