Abstract: A transseptal catheter delivery system includes an elongate first tubular member and an elongate second tubular member receivable within the first tubular member. The first tubular member includes an adjustable portion adjacent a distal end. The second tubular member is adapted to receive an instrument to be placed in the left ventricle, and includes a curved portion adjacent its distal end in a relaxed state. The adjustable portion is deflectable toward the atrial septum to guide a puncturing tool and/or guide insertion of the second tubular member through a septal puncture into the left atrium. Within the left atrium, the curved portion is oriented toward the left ventricle to guide insertion of a guide wire, and subsequently the second tubular member, into the left ventricle. Methods of transvenously accessing a left ventricle are also provided.

Abstract: A transseptal catheter delivery system includes an elongate first tubular member and an elongate second tubular member receivable within the first tubular member. The first tubular member includes an adjustable portion adjacent a distal end. The second tubular member is adapted to receive an instrument to be placed in the left ventricle, and includes a curved portion adjacent its distal end in a relaxed state. The adjustable portion is deflectable toward the atrial septum to guide a puncturing tool and/or guide insertion of the second tubular member through a septal puncture into the left atrium. Within the left atrium, the curved portion is oriented toward the left ventricle to guide insertion of a guide wire, and subsequently the second tubular member, into the left ventricle. Methods of transvenously accessing a left ventricle are also provided.

Abstract: A transseptal catheter delivery system includes an elongate first tubular member and an elongate second tubular member receivable within the first tubular member. The first tubular member includes an adjustable portion adjacent a distal end. The second tubular member is adapted to receive an instrument to be placed in the left ventricle, and includes a curved portion adjacent its distal end in a relaxed state. The adjustable portion is deflectable toward the atrial septum to guide a puncturing tool and/or guide insertion of the second tubular member through a septal puncture into the left atrium. Within the left atrium, the curved portion is oriented toward the left ventricle to guide insertion of a guide wire, and subsequently the second tubular member, into the left ventricle. Methods of transvenously accessing a left ventricle are also provided.

Abstract: A transseptal catheter delivery system includes an elongate first tubular member and an elongate second tubular member receivable within the first tubular member. The first tubular member includes an adjustable portion adjacent a distal end. The second tubular member is adapted to receive an instrument to be placed in the left ventricle, and includes a curved portion adjacent its distal end in a relaxed state. The adjustable portion is deflectable toward the atrial septum to guide a puncturing tool and/or guide insertion of the second tubular member through a septal puncture into the left atrium. Within the left atrium, the curved portion is oriented toward the left ventricle to guide insertion of a guide wire, and subsequently the second tubular member, into the left ventricle. Methods of transvenously accessing a left ventricle are also provided.

Abstract: A transseptal catheter delivery system includes an elongate first tubular member and an elongate second tubular member receivable within the first tubular member. The first tubular member includes an adjustable portion adjacent a distal end. The second tubular member is adapted to receive an instrument to be placed in the left ventricle, and includes a curved portion adjacent its distal end in a relaxed state. The adjustable portion is deflectable toward the atrial septum to guide a puncturing tool and/or guide insertion of the second tubular member through a septal puncture into the left atrium. Within the left atrium, the curved portion is oriented toward the left ventricle to guide insertion of a guide wire, and subsequently the second tubular member, into the left ventricle. Methods of transvenously accessing a left ventricle are also provided.

Abstract: An apparatus for guiding the placement of a subcutaneous device that includes a strap having an indentation configured for a fold of skin and fat layer to be positioned within the indentation as the subcutaneous device is advanced to a desired implantation site.

Abstract: An apparatus for guiding the placement of a subcutaneous device that includes a strap having an indentation configured for a fold of skin and fat layer to be positioned within the indentation as the subcutaneous device is advanced to a desired implantation site.

Abstract: An introducer system and method for positioning and fixedly engaging a lead at an implantation site that includes a torque transfer sheath, extending from a proximal end to a distal end, receiving the lead, an outer sheath, having a distal end, receiving the lead positioned within the torque transfer sheath, and a handle operable between a first position enabling advancement and retraction of the lead through the handle and a second position fixedly engaging a proximal end of the lead within the handle. The lead is advanced through the outer sheath to extend outward a predetermined distance from the distal end of the outer sheath and the fixation helix is rotated through the predetermined distance to be fixedly engaged at the implantation site in response to simultaneous rotation and advancement of the lead and the torque transfer sheath through rotation and advancement of the handle in the second position.

Abstract: The present invention includes a “Z shaped” configuration for a pair of internal windings of a fiber core of a medical electrical lead which can be configured as or windings to provide counter-rotation an implanted cardiac lead. When fully assembled and implanted within a patient, a screw-type active fixation electrode, such as a helical electrode, electrically couples to a coil conductor and mechanically couples to a loop formed at an end of the Z-shaped braided fiber. To remove the lead, an axial traction force is applied and as the Z-shaped braids begin to unwind rotational forces operate to unscrew the helical electrode. A lead constructed according to the present invention rotates counterclockwise and thus essentially unscrews the active fixation electrode.

Abstract: Apparatus and methods are disclosed for reducing the potentially harmful effects of electromagnetic waves on an implantable medical device. In one embodiment of the present invention, an implantable medical system comprising a dual threshold magnetic sensor capable of detecting an elevated magnetic field is disclosed. The sensor can comprise a solid-state sensor capable of detecting a static magnetic field in excess of about 1500 Gauss. The magnetic sensor can be operatively coupled to electronics that are capable of altering the operation of the system upon detection of an elevated magnetic field by the magnetic sensor.

Abstract: An electrical lead end cap includes a body defining a bore therein capable of receiving and retaining an end of an electrical lead and a connector capable of electrically coupling conductors leading to at least two electrodes. A method includes routing an electrical current induced in an electrical lead conductor disposed within body tissue to a plurality of electrodes, electrically coupled with the body tissue, via a circuit within an end cap attached to the electrical lead.

Abstract: An electrical lead includes an elongate body having a proximal end portion and a distal end portion, a first electrode disposed adjacent and joined to the distal end portion of the elongate body. Current flow within the first electrode is limited when a predetermined condition occurs, such as the generation of an electromagnetic field having a predetermined frequency range. The medical electrical lead may further comprise one or more second electrodes disposed adjacent the first electrode and joined to the elongate body to shunt current to body tissue when the predetermined condition occurs.

Abstract: An introducer system and method for positioning and fixedly engaging a lead at an implantation site that includes a torque transfer sheath, extending from a proximal end to a distal end, receiving the lead, an outer sheath, having a distal end, receiving the lead positioned within the torque transfer sheath, and a handle operable between a first position enabling advancement and retraction of the lead through the handle and a second position fixedly engaging a proximal end of the lead within the handle. The lead is advanced through the outer sheath to extend outward a predetermined distance from the distal end of the outer sheath and the fixation helix is rotated through the predetermined distance to be fixedly engaged at the implantation site in response to simultaneous rotation and advancement of the lead and the torque transfer sheath through rotation and advancement of the handle in the second position.

Abstract: An electrical lead end cap includes a body defining a bore therein capable of receiving and retaining an end of an electrical lead and a connector capable of electrically coupling conductors leading to at least two electrodes. A method includes routing an electrical current induced in an electrical lead conductor disposed within body tissue to a plurality of electrodes, electrically coupled with the body tissue, via a circuit within an end cap attached to the electrical lead.

Abstract: Apparatus and methods are disclosed for reducing the potentially harmful effects of electromagnetic waves on an implantable medical device. In one embodiment of the present invention, an implantable medical system comprising a dual threshold magnetic sensor capable of detecting an elevated magnetic field is disclosed. The sensor can comprise a solid-state sensor capable of detecting a static magnetic field in excess of about 1500 Gauss. The magnetic sensor can be operatively coupled to electronics that are capable of altering the operation of the system upon detection of an elevated magnetic field by the magnetic sensor.

Abstract: An electrical lead includes an elongate body having a proximal end portion and a distal end portion, a first electrode disposed adjacent and joined to the distal end portion of the elongate body. Current flow within the first electrode is limited when a predetermined condition occurs, such as the generation of an electromagnetic field having a predetermined frequency range. The medical electrical lead may further comprise one or more second electrodes disposed adjacent the first electrode and joined to the elongate body to shunt current to body tissue when the predetermined condition occurs.

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.