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: The present invention provides a practical, multi-polar, in-line connector system for use in connecting implantable medical devices (IMD) and associated non-standard, low profile medical electrical leads. In addition, the present invention provides a system that uses tool less, frictional, sealed, compressive electrical connections for most or all of the electrical interconnections between an IMD and a low profile lead. A protective sleeve seals the lead connector to the non-standard port to prevent intrusion of body fluids therein. In addition, optional microchip-based circuitry coupled to the sleeve enables wireless communication and remote programming for diverse IMDs. Memory associated with the circuitry can store, update and reprogram a wide variety of information relevant to the IMD, the patient, and the attending physician, among others. For example, the microchip may be used to identify the lead type and characteristics, as well as other useful data.

Abstract: A lead for delivering electrical signals to and/or receive electrical signals from a human heart that includes a solid inner conductor, and a fixation device having a titanium nitride coated surface and electrically coupled to the inner conductor. A steroid is applied to the titanium nitride surface of the fixation device, and at least one layer of insulation is positioned around the inner conductor. A conductive coil is positioned around and is insulated from the inner conductor, an electrode ring electrically coupled to the conductive coil is positioned around and is electrically isolated from the inner conductor, and an insulating spacer is positioned between and electrically isolates the ring electrode and the fixation device.

Abstract: An improved medical lead assembly and method of use is provided. The lead assembly includes a lead body, and a spring member positioned adjacent to the lead body. The spring member may be deployed a selectable amount to maintain the lead body in a fixed location within a patient's body. The spring member may be an expandable coil, a mesh structure that is similar to a stent, or any other similar device that may be positioned in a low-profile state during a lead implant procedure. After the lead is positioned at a target destination, the spring member may be deployed an amount that is selected based on the characteristics of the surrounding tissue, including vessel size. According to one aspect of the invention, the lead assembly may provide means for facilitating chronic lead extraction.

Abstract: A method and apparatus for dynamically fixating and removing a lead in a vasculature of a body. At least one segmenting means such as a collar is disposed at a distal end of the lead forming a deployable actuable segment adapted to dynamically assume an engaging and retracted position. In an engaging position, the actuable segment dynamically and varyingly adapts into a shape or shapes to engage a vessel. In a retracted position the shape or shapes collapse thus maintaining the original geometry of the lead in the vasculature. The actuable segment assumes a deployed or retracted position based on the flexural condition of the segment, respectively.

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 introducer catheter used to deliver an endocardial cardiac electrode has a stylet lumen which collapses upon removal of the stylet to allow for more clearance for the lead and connector to pass when the catheter is removed after lead placement. The collapsible stylet lumen permits the introducer catheter size to be reduced to 8 or 9 French and provide for passage of a 4 French lead.

Abstract: The present invention provides a practical, multi-polar, in-line connector system for use in connecting implantable medical devices (IMD) and associated non-standard, low profile medical electrical leads. In addition, the present invention provides a system that uses tool less, frictional, sealed, compressive electrical connections for most or all of the electrical interconnections between an IMD and a low profile lead. A protective sleeve seals the lead connector to the non-standard port to prevent intrusion of body fluids therein. In addition, optional microchip-based circuitry coupled to the sleeve enables wireless communication and remote programming for diverse IMDs. Memory associated with the circuitry can store, update and reprogram a wide variety of information relevant to the IMD, the patient, and the attending physician, among others. For example, the microchip may be used to identify the lead type and characteristics, as well as other useful data.

Abstract: A medical electrical lead including an inflatable member at a distal tip section, and a system of use, are disclosed. The inflation member is adapted to engage the walls of a cardiac vein or coronary artery to occlude the vessel. According to one aspect of the invention, the inflation member is formed of a bio-absorbable material. In another embodiment, the inflation member is a micro-porous material. The lead of the current invention may include a port located distal to the inflation member to deliver radiopaque dye or any other substance to a vessel when the inflation member is in the inflated state. This allows a fluoroscopic image of a patient's vascular system to be obtained while the lead is in place within a vessel. A perfusion lumen may be provided to allow a partial flow of blood to continue around the inflation member when the inflation member is occluding a vessel. In one embodiment, lead is provided with a lumen for receiving a stiffening member such as a stylet to aid in lead placement.

Abstract: An implantable electrical lead having a tip electrode and a ring electrode located proximal to the tip electrode. A flexible spacer is located between the electrodes and includes a tubular plastic member having a thickness gradually increasing proximally and distally of a point intermediate the electrodes. Optionally the spacer includes an inner member of a lower durometer plastic, gradually decreasing in thickness proximally and distally from the intermediate point.

Abstract: An introducer catheter used to deliver an endocardial cardiac electrode has a stylet lumen which collapses upon removal of the stylet to allow for more clearance for the lead and connector to pass when the catheter is removed after lead placement. The collapsible stylet lumen permits the introducer catheter size to be reduced to 8 or 9 French and provide for passage of a 4 French lead.

Abstract: A medical electrical lead including an inflatable member at a distal tip section, and a system of use, are disclosed. The inflation member is adapted to engage the walls of a cardiac vein or coronary artery to occlude the vessel. According to one aspect of the invention, the inflation member is formed of a bio-absorbable material. In another embodiment, the inflation member is a micro-porous material. The lead of the current invention may include a port located distal to the inflation member to deliver radiopaque dye or any other substance to a vessel when the inflation member is in the inflated state. This allows a fluoroscopic image of a patient's vascular system to be obtained while the lead is in place within a vessel. A perfusion lumen may be provided to allow a partial flow of blood to continue around the inflation member when the inflation member is occluding a vessel. In one embodiment, lead is provided with a lumen for receiving a stiffening member such as a stylet to aid in lead placement.

Abstract: Endocardial implantable cardiac leads are disclosed for applying electrical stimulation to and/or sensing electrical activity of the heart at one or more distal electrode positioned at a cardiac implantation site within a cardiac vessel adjacent to and at a desired orientation to the left ventricle or atrium of the heart. The distal electrode(s) is supported by a tubular electrode support having a diameter large enough to bear against the blood vessel wall and a support lumen that allows blood to flow through it. A retention stent extends proximally from a distal stent end fixed to the tubular electrode support to a proximal stent end. After advancement to the cardiac implantation site employing a lead delivery mechanism, the retention stent is expandable from a collapsed stent state in which the outer diameter of the retention stent is less than the inner diameter of the vessel to an expanded stent state.

Abstract: A medical electrical lead having an elongated lead body carrying a conductor therein, the lead body being formed of an inner sleeve of a first, relatively more rigid plastic and an outer sheath of a second, relatively less rigid plastic, the inner sleeve having a tubular portion and having outwardly extending helical ridges extending along its length, the ridges having lateral wall surfaces extending radially from the tubular portion and an outer sheath over the inner sleeve and in contact with the lateral wall surfaces of the inner sleeve. A fixation helix may be mounted at the distal end of the lead body and a conductor, which is also rotatable relative to the lead body may be located within the inner, tubular sleeve. Conductors may also be located between the ridges of the inner sleeve, embedded in the outer sheath.

Abstract: A medical electrical lead having an electrode head with an internal lumen mounted to a proximal portion of the lead body and a rotatable fixation helix advanceable from the internal lumen. The helix is mounted to a rotatable shaft which is provided with a central shaft portion and circumferential shoulders proximal and distal to the central shaft portion. A seal is mounted in the lumen of the electrode head, encircling the shaft and C-shaped seal retainers are mounted in the lumen of the electrode head member proximal and distal to the seal.

Abstract: A cardiac pacing lead having a plurality of individually insulated conductors arranged as a multifilar coil. The lead includes a connector assembly and a ring electrode assembly, each of which are optimized for use in conjunction with conductors arranged in the form of a multifilar coil. The connector assembly takes the form of an in-line connector having a plurality of linearly arranged connecting surfaces, each coupled to one of the conductors in the multifilar coil. The ring electrode assembly is constructed such that it displays the same outer diameter as the pacing lead. In both assemblies, conductors are coupled by means of welds, rather than by crimping or swaging.

Abstract: An in-line connector assembly for use with electrode leads employing plural, coaxial, coiled conductors. The connector assembly includes a connector ring, a connector pin, and an insulating sleeve separating the connector ring and connector pin. The insulating sleeve is molded to the connector ring and connector pin, prior to attachment to the proximal end of a multiconductor lead.