Abstract: A catheter for mapping and/or ablating a region of the heart includes an intermediate section that is connected to a tip assembly at a preset angle by a flexible preshaped section that is more flexible than the intermediate section. The flexible section may absorb displacement force applied to the tip assembly, such as when the tip assembly encounters uneven tissue surface, without displacing the intermediate section. The flexible section prevents excessive force from being applied to the tip assembly, reducing the risk of any of the following: a) mechanical perforation, b) steam pop, c) burying the tip assembly in the myocardium resulting in high temperatures, low energy delivery, thrombus formation and char formation.

Abstract: A catheter for mapping and/or ablating a region of the heart includes an intermediate section that is connected to a tip assembly at a preset angle by a flexible preshaped section that is more flexible than the intermediate section. The flexible section may absorb displacement force applied to the tip assembly, such as when the tip assembly encounters uneven tissue surface, without displacing the intermediate section. The flexible section prevents excessive force from being applied to the tip assembly, reducing the risk of any of the following: a) mechanical perforation, b) steam pop, c) burying the tip assembly in the myocardium resulting in high temperatures, low energy delivery, thrombus formation and char formation.

Abstract: A catheter for mapping and/or ablating continuous linear or circumferential lesions at the intersection of a generally flat structure, such as the left atrium, and the ostium of generally cavernous regions of the heart, including pulmonary vein and the pulmonary venous antrum, comprises a catheter body with an intermediate section that is connected to a tip assembly by a highly flexible section. The intermediate section has at its distal end a preformed section, e.g., a curve, the intermediate section being deflectable in a direction opposite to the curve. The highly flexible section presets the tip assembly at an off-axis and/or off-plane angles from the preformed section. Accordingly, the preformed section is adapted to sit in the region and the preset angles of the ablation assembly enable contact with surrounding tissue.

Abstract: An introducer system for implantation of pacemaker leads into the venous system of the human heart through the coronary sinus is comprised of a flexible, elongate, outer elongate element having a first shape or bias along a portion. The first shape on the outer element may be prebiased or may be initially straight and subsequently biased once deployed in the body chamber. A flexible, elongate, telescopic inner elongate element has a second shape or bias on its distal portion and has the first shape or bias on a more proximal portion. The inner elongate element is telescopically disposed in the outer sheath.

Abstract: A catheter for mapping and/or ablating continuous linear or circumferential lesions at the intersection of a generally flat structure, such as the left atrium, and the ostium of generally cavernous regions of the heart, including pulmonary vein and the pulmonary venous antrum, comprises a catheter body with an intermediate section that is connected to a tip assembly by a highly flexible section. The intermediate section has at its distal end a preformed section, e.g., a curve, the intermediate section being deflectable in a direction opposite to the curve. The highly flexible section presets the tip assembly at an off-axis and/or off-plane angles from the preformed section. Accordingly, the preformed section is adapted to sit in the region and the preset angles of the ablation assembly enable contact with surrounding tissue.

Abstract: A catheter for mapping and/or ablating continuous linear or circumferential lesions at the intersection of a generally flat structure, such as the left atrium, and the ostium of generally cavernous regions of the heart, including pulmonary vein and the pulmonary venous antrum, comprises a catheter body with an intermediate section that is connected to a tip assembly by a highly flexible section. The intermediate section has at its distal end a preformed section, e.g., a curve, the intermediate section being deflectable in a direction opposite to the curve. The highly flexible section presets the tip assembly at an off-axis and/or off-plane angles from the preformed section. Accordingly, the preformed section is adapted to sit in the region and the preset angles of the ablation assembly enable contact with surrounding tissue.

Abstract: The invention is defined as a precurved coronary sinus guiding introducer for use in a cardiomyopathic heart comprising a flexible elongated member with a proximal and distal end. The elongated member comprises a generally straight, proximal portion and a precurved distal portion. In one embodiment the proximal portion and distal portion are formed to lie is a common plane. In another embodiment the portions are angulated with respect to each other in different planes. The precurved distal portion comprises at least one curved subportion and at least one curved or straight subportion. The precurved distal subportion curves through a generally circular arc away and is defined by a chord of predetermined length. The precurved distal subportion has a predetermined height above the chord. The curved or straight subportion is the distal section of the precurved distal portion.

Abstract: A class of introducers is comprised of a plurality of straight sections and at least two curved sections with a pre-determined sense of curvature preceded, separated and followed by the straight sections, which introducer is adapted by its shape to access the septal wall or apex of a heart. One of the plurality of straight sections is a distal-most straight section. The straight and curved sections define a predetermined three dimensional shape by means of the distal straight section lying out of plane with respect to the remaining curved and straight sections.

Abstract: An introducer system is used for implantation of pacemaker leads into the venous system of the human heart through the coronary sinus. The system is comprised of three telescopic components, an inner telescoping core, a precurved inner telescoping sheath, and an outer telescoping sheath, introducer, guide or catheter. In an embodiment where a core is used it is torsionally stiff. In an embodiment where no core is used, the inner sheath is torsionally stiff. In either case, the member which is torsionally stiff is torqueable. In general, the inner sheath and outer guide will be both laterally and torsionally flexible, while the core will be torsionally stiff. The core and inner sheath, when curved together in the venous system and proximally coupled, will be sufficiently bound to each other that proximal rotation of the core will be coupled to and cause distal rotation of the inner sheath.

Abstract: A conductive guidewire having at least an exposed distal tip is endovascularly steered into an epicardial surface of a heart via the venous tributaries of the coronary sinus. A selected site is contacted by the tip of the guidewire and tested by means of the guidewire to determine suitability for permanent lead implantation. Implantation of the lead at the contacted site is contingent on the determination of the adequacy of all electrophysiological parameters. Testing includes the steps of determining the amplitude and slew rate of the local electrogram, generating an electrical stimulus, communicating the stimulus to the contacted site by means of the guidewire, sensing an electrophysiological response to the stimulus through the guidewire and determining that the pacing threshold parameters are appropriate. A permanent pacing lead is then chosen and guided by means of the guidewire to the contacted site and implanted.

Abstract: An introducer system for implantation of pacemaker leads into the venous system of the human heart through the coronary sinus is comprised of a flexible, elongate, outer elongate element having a first shape or bias along a portion. The first shape on the outer element may be prebiased or may be initially straight and subsequently biased once deployed in the body chamber. A flexible, elongate, telescopic inner elongate element has a second shape or bias on its distal portion and has the first shape or bias on a more proximal portion. The inner elongate element is telescopically disposed in the outer sheath.

Abstract: The invention is defined as a precurved coronary sinus guiding introducer for use in a cardiomyopathic heart comprising a flexible elongated member with a proximal and distal end. The elongated member comprises a generally straight, proximal portion and a precurved distal portion. In one embodiment the proximal portion and distal portion are formed to lie is a common plane. In another embodiment the portions are angulated with respect to each other in different planes. The precurved distal portion comprises at least one curved subportion and at least one curved or straight subportion. The precurved distal subportion curves through a generally circular arc away and is defined by a chord of predetermined length. The precurved distal subportion has a predetermined height above the chord. The curved or straight subportion is the distal section of the precurved distal portion.

Abstract: An introducer system is used for implantation of pacemaker leads into the venous system of the human heart through the coronary sinus. The system is comprised of three telescopic components, an inner telescoping core, a precurved inner telescoping sheath, and an outer telescoping sheath, introducer, guide or catheter. In an embodiment where a core is used it is torsionally stiff. In an embodiment where no core is used, the inner sheath is torsionally stiff. In either case, the member which is torsionally stiff is torqueable. In general, the inner sheath and outer guide will be both laterally and torsionally flexible, while the core will be torsionally stiff. The core and inner sheath, when curved together in the venous system and proximally coupled, will be sufficiently bound to each other that proximal rotation of the core will be coupled to and cause distal rotation of the inner sheath.