Abstract: A medical electrical lead includes a conductive component coupling a coil to a wire or cable; the conductive component includes a first side, a second side, a first groove formed in the first side and a second groove formed in the second side. The first groove holds a portion of the cable and the second groove holds a portion of the coil.

Abstract: A method for making an elongate medical device includes coupling a conductive fitting to an elongate conductor and providing an opening through an insulative layer in proximity to the fitting in order to expose the fitting.

Abstract: A cardiac transvenous defibrillation lead has a continuous coil conductor within a layer of insulation. A portion of the coil conductor is exposed as a defibrillation electrode. In order to enhance fluoroscopic visualization of the exposed electrode during implant, the end of the exposed electrode is marked with a radiopaque element. The element may be in the form of an adhesive filled with radiopaque material that is used to backfill under the layer of insulation. Alternatively, a tube made of radiopaque material may be installed between the layer of insulation and the coil conductor.

Abstract: A heart model provides a simulative environment for lead implantation and affixation. In one embodiment, removable silicone plugs are provided at appropriate locations so that an inserted lead can be affixed to the plugs with a helical tip. A simulative venous structure is provided that has increased lubricity to facilitate the insertion and manipulation of the lead.

Abstract: A system including an implantable defibrillation electrode includes a first layer of porous Polytetrafluoroethylene (PTFE) adjacent to at least one surface of the defibrillation electrode, the first layer of porous PTFE having a fibril length adapted to bleed gas away from the at least one surface of the defibrillation electrode, and a second layer of porous PTFE formed over the first layer, the second layer of porous PTFE having a fibril length adapted to prevent substantially all tissue in-growth.

Abstract: A method for making an elongate medical device includes coupling a conductive fitting to an elongate conductor and providing an opening through an insulative layer in proximity to the fitting in order to expose the fitting.

Abstract: A heart model provides a simulative environment for lead implantation and affixation. In one embodiment, removable silicone plugs are provided at appropriate locations so that an inserted lead can be affixed to the plugs with a helical tip. A simulative venous structure is provided that has increased lubricity to facilitate the insertion and manipulation of the lead.

Abstract: A medical electrical lead includes a conductive component coupling a coil to a wire or cable; the conductive component includes a first side, a second side, a first groove formed in the first side and a second groove formed in the second side. The first groove holds a portion of the cable and the second groove holds a portion of the coil.

Abstract: An implantable medical device lead having an integral biostable in-sutu grown oxide insulation and process for forming that includes a lead body extending from a proximal end to a distal end, and a plurality of conductor wires electrically coupling the proximal end and the distal end of the lead body, with one or more of the plurality of conductor wires being formed of a material having a chemically modifiable surface for producing an insulating oxide layer thereon. An insulation layer corresponding to the native oxide layer is formed about the one or more of the plurality of conductor wires.

Abstract: Disclosed is an improved system and method to selectively promote tissue ingrowth on, or adjacent to, an implantable medical device. In one embodiment, at least one surface of the housing of a medical device is in contact with a first portion of a porous PTFE having a pore size adapted to prevent substantially all tissue in-growth. This first portion, or layer, of porous PTFE material is further in contact at predetermined locations with an additional porous PTFE layer having a pore size adapted to selectively promote tissue in-growth only at the predetermined locations. Each of the PTFE layers may be formed of porous PTFE tubing or tape. Alternatively, the two layers may comprise a single composite structure that has a more porous material exposed on a first surface, and a less porous, more dense, material on a second surface. Another embodiment of the invention involves forming the layers of PTFE into a removable member that is adjacent to at least one surface of the implantable medical device.

Abstract: Disclosed is an improved system and method to selectively promote tissue in-growth on, or adjacent to, an implantable medical device. In one embodiment, at least one surface of the housing of a medical device is in contact with a first portion of a porous PTFE having a pore size adapted to prevent substantially all tissue in-growth. This first portion, or layer, of porous PTFE material is further in contact at predetermined locations with an additional porous PTFE layer having a pore size adapted to selectively promote tissue in-growth only at the predetermined locations. Each of the PTFE layers may be formed of porous PTFE tubing or tape. Alternatively, the two layers may comprise a single composite structure that has a more porous material exposed on a first surface, and a less porous, more dense, material on a second surface. Another embodiment of the invention involves forming the layers of PTFE into a removable member that is adjacent to at least one surface of the implantable medical device.

Abstract: A cardiac transvenous defibrillation lead has a continuous coil conductor within a layer of insulation. A portion of the coil conductor is exposed as a defibrillation electrode. In order to enhance fluoroscopic visualization of the exposed electrode during implant, the end of the exposed electrode is marked with a radiopaque element. The element may be in the form of an adhesive filled with radiopaque material that is used to backfill under the layer of insulation. Alternatively, a tube made of radiopaque material may be installed between the layer of insulation and the coil conductor.

Abstract: A cardiac transvenous defibrillation lead has a continuous coil conductor within a layer of insulation. A portion of the coil conductor is exposed as a defibrillation electrode. In order to enhance fluoroscopic visualization of the exposed electrode during implant, the end of the exposed electrode is marked with a radiopaque element. The element may be in the form of an adhesive filled with radiopaque material that is used to backfill under the layer of insulation. Alternatively, a tube made of radiopaque material may be installed between the layer of insulation and the coil conductor.

Abstract: Disclosed is an improved system and method to selectively promote tissue in-growth on, or adjacent to, an implantable medical device. In one embodiment, at least one surface of the housing of a medical device is in contact with a first portion of a porous PTFE having a pore size adapted to prevent substantially all tissue in-growth. This first portion, or layer, of porous PTFE material is further in contact at predetermined locations with an additional porous PTFE layer having a pore size adapted to selectively promote tissue in-growth only at the predetermined locations. Each of the PTFE layers may be formed of porous PTFE tubing or tape. Alternatively, the two layers may comprise a single composite structure that has a more porous material exposed on a first surface, and a less porous, more dense, material on a second surface. Another embodiment of the invention involves forming the layers of PTFE into a removable member that is adjacent to at least one surface of the implantable medical device.

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 implantable electrical lead having a lead body with a longitudinal lumen therein and a stranded electrical conductor located in the lumen and which exits the lumen at a distal portion of the lead body, the distal end of the conductor being curved to form a loop and reentering the lumen, terminating within the lumen alongside a more proximal portion of the conductor. The portion of the conductor exterior to the lumen is wound around the lead body to form a coiled electrode. In some embodiments the distal end of the conductor is coupled to a more proximal portion of the conductor to form a loop and the loop is wound around the lead body to form a bifilar coil. In other embodiments the conductor is wound around the lead body to form a mono-filar coil. The distal end of the conductor is mechanically and electrically coupled to a more proximal portion of the conductor, within the lumen.

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: In an endocardial, active fixation, screw-in lead of the type having a fixation helix adapted to be rotated in a first, advancement direction out of an electrode head chamber and into cardiac tissue by rotation of a lead connector end and attached lead conductor with respect to an insulating sheath in the first direction and retracted into the chamber by rotation of the lead connector in the opposite, retraction direction, a retraction stop mechanism for preventing over rotation of the helix in the retraction direction. The rotational motion of the lead conductor is transmitted to the helix by a connecting assembly and is translated into axial advancement and retraction of the helix by a guide cooperating with the helix turns. A retraction stop mechanism stops rotation of the helix in the retraction direction upon full retraction of the helix into the chamber and allows rotation of helix in the advancement direction.

Abstract: A medical electrical lead having an elongated lead body provided with an internal longitudinally extending lumen carrying an elongated stranded or cabled conductor and an electrode coil, located on said lead body. The coil is coupled to the conductor by a conductive sleeve having a tubular portion which has an internal lumen through which the conductor passes and a groove or bore which engages only a portion of a turn or turns of the electrode coil, such that the coil is oriented generally perpendicular to the internal lumen of said sleeve and to the conductor.