Abstract: A hybrid lateral vein introducer which includes a conventional splittable hemostatic valve, which comprises two symmetrical wing extending from a splittable hub. A conventional splittable proximal sheath portion is coupled to and extends from the hub. The sheath portion is a conventional soft pliable sheath, which has limited torqueability, but adequate flexibility to be maneuvered in the cardiac vascular system. At a predetermined distance from the valve, the sheath is coupled to a reinforced sheath portion. Reinforced sheath portion is reinforced sufficiently to allow for good integrity and crush resistance while maintaining flexibility of the sheath portion. A proximal segment of the sheath portion is reinforced, but still splittable. Alternatively, the entire length of the sheath portion including the proximal segment and distal portions are rendered splittable.

Abstract: An introducer sheath comprising a curved shape that follows the right sided vasculature when introduced through the right side subclavian vein and which stops far short of the coronary ostium in the right atrium. No attempt is made to access the coronary sinus through the sheath. The sheath establishes a fulcrum point on the upper lateral wall of the superior vena cava and comprises the ability to be removed from the implanted pacemaker lead without flipping the distal end of the sheath to cause a pull back of the pacemaker lead. The more proximal portions of the sheath extend through the superior vena cava and provide a force which biases the sheath against the lateral wall of the lower portion of the superior vena cava to establish a fulcrum or pivot point which positions the distal end of sheath at the desired location.

Abstract: A method of inserting a pacing lead having a preformed shape into a coronary sinus to pace the left atrium includes providing a lead having an elongated body and proximal and tip sections. The sections are configured such that a first angle less than 90 degrees is defined between the lead body and proximal section and a second angle is defined between the tip and proximal sections. The method further comprises advancing the pacing wire towards the opening of the coronary sinus and advancing the wire into the coronary sinus, such that the first angle is compressed by the coronary sinus opening and a tip electrode included on the tip section contacts the wall of the coronary sinus near the left atrium operably extending the second angle to assure constant contact between the wall of the coronary sinus and the tip electrode.

Abstract: A pacing lead for implantation in a coronary sinus having an opening and a wall defining an interior and presenting a diameter dimension. The pacing lead includes an elongated lead body, a resilient fixation element, and at least one electrode on either the lead body or the fixation element. The fixation element extends from the pacing portion and defines a loop structure laterally adjacent the pacing portion. The loop structure presents a predetermined width dimension greater than the diameter dimension of the coronary sinus, wherein when the loop structure is inserted into the opening of the coronary sinus, the loop structure is laterally compressed by the wall of the coronary sinus and the electrode is biased against the wall of the coronary sinus.

Abstract: A pacing lead for implantation in the pericardial space includes an elongated lead body, a compression fixation element, and at least one electrode on either the lead body or the fixation element. The fixation element defines a resilient structure, and is positioned and dimensioned so that when the lead is disposed in the pericardial space, the resilient fixation element is compressed between the parietal and visceral pericardium, thereby biasing the electrode against the myocardium and providing positional stabilization to the lead. Further positional stability may be provided mechanically with structures enabling the application of adhesive or with fixation screw or tine elements.

Abstract: A method of inserting a pacing lead having a preformed shape into a coronary sinus to pace the left atrium includes providing a lead having an elongated body and proximal and tip sections. The sections are configured such that a first angle less than 90 degrees is defined between the lead body and proximal section and a second angle is defined between the tip and proximal sections. The method further comprises advancing the pacing wire towards the opening of the coronary sinus and advancing the wire into the coronary sinus, such that the first angle is compressed by the coronary sinus opening and a tip electrode included on the tip section contacts the wall of the coronary sinus near the left atrium operably extending the second angle to assure constant contact between the wall of the coronary sinus and the tip electrode.

Abstract: A pacing lead for implantation in a coronary sinus having an opening and a wall defining an interior and presenting a diameter dimension. The pacing lead includes an elongated lead body, a resilient fixation element, and at least one electrode on either the lead body or the fixation element. The fixation element extends from the pacing portion and defines a loop structure laterally adjacent the pacing portion. The loop structure presents a predetermined width dimension greater than the diameter dimension of the coronary sinus, wherein when the loop structure is inserted into the opening of the coronary sinus, the loop structure is laterally compressed by the wall of the coronary sinus and the electrode is biased against the wall of the coronary sinus.

Abstract: A device and method for slitting a first elongated flexible catheter/sheath used with an elongated flexible component. The device includes a handle, an elongated groove and a cutter member. The cutter member has a sharp distally located cutting edge and a top surface from which a finger projects distally. The cutting edge is located under the finger and is arranged to be located within the annular space between the component and the first catheter/sheath when the first catheter/sheath is within the groove. The cutting edge serves to slice the first catheter/sheath longitudinally when the first catheter/sheath is pulled in a proximal direction. The finger protects the component from injury.

Abstract: A pacing lead for implantation in the pericardial space includes an elongated lead body, a compression fixation element, and at least one electrode on either the lead body or the fixation element. The fixation element defines a resilient structure, and is positioned and dimensioned so that when the lead is disposed in the pericardial space, the resilient fixation element is compressed between the parietal and visceral pericardium, thereby biasing the electrode against the myocardium and providing positional stabilization to the lead. Further positional stability may be provided mechanically with structures enabling the application of adhesive or with fixation screw or tine elements.

Abstract: A catheter for mapping and/or ablating a region of the heart, comprises a catheter body with an intermediate section that is connected to a tip assembly by a highly flexible preshaped section. The highly flexible section presets the tip assembly at an off-axis and/or off-plane angles from the intermediate section, to provide the following: a) The intermediate section when deflected approximates the generally convex region of the cavo-tricuspid isthmus and the preset angle of the flexible section is off axis in the same plane and same direction as deflection of the intermediate section to enable the tip assembly to contact the cavo-tricuspid isthmus for ablation and/or mapping. b) The intermediate section when deflected approximates the generally concave region of the VA/RV/LA/LV and the preset angle in the same plane and opposite direction of deflection enables the tip assembly to contact the walls of the cavity for ablation and/or mapping.

Abstract: In accordance with the present invention, a cardiac device is provided comprising a first electrode for sensing an electrical pulse in an atrium, a second electrode for sensing an electrical pulse in an atrium, a microcontroller coupled to the first electrode and the second electrode for determining time between the first and second pulses, and an electrode for stimulating a chamber of a heart wherein the stimulation is based on the first and second pulses.

Abstract: A pacemaker lead (18) is implanted by using a two anchor system. One anchor (916) to first secure the position of an introducer (14) through which the pacemaker lead will be implanted, and a second anchor (20) used for implanting the distal tip of the pacemaker lead (18). Examples of the anchors included various types of mechanical anchors or mechanical anchor combinations such as a suction anchor, a barbed needle, or a needle and balloon combination. The anchors can be used in the pericardial space in the heart by disposing an elongate instrument into the venous system of the heart; puncturing the venous system at a predetermined position; disposing the elongate instrument into the pericardial space at a predetermined location in the pericardial space; and implanting a pacemaker lead at the predetermined position.

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 method of inserting a pacing lead having a preformed shape into a coronary sinus to pace the left atrium includes providing a lead having an elongated body and proximal and tip sections. The sections are configured such that a first angle less than 90 degrees is defined between the lead body and proximal section and a second angle is defined between the tip and proximal sections. The method further comprises advancing the pacing wire towards the opening of the coronary sinus and advancing the wire into the coronary sinus, such that the first angle is compressed by the coronary sinus opening and a tip electrode included on the tip section contacts the wall of the coronary sinus near the left atrium operably extending the second angle to assure constant contact between the wall of the coronary sinus and the tip electrode.

Abstract: A pacing lead for implantation in a coronary sinus having an opening and a wall defining an interior and presenting a diameter dimension. The pacing lead includes an elongated lead body, a resilient fixation element, and at least one electrode on either the lead body or the fixation element. The fixation element extends from the pacing portion and defines a loop structure laterally adjacent the pacing portion. The loop structure presents a predetermined width dimension greater than the diameter dimension of the coronary sinus, wherein when the loop structure is inserted into the opening of the coronary sinus, the loop structure is laterally compressed by the wall of the coronary sinus and the electrode is biased against the wall of the coronary sinus.

Abstract: A device and method for slitting a first elongated flexible catheter/sheath used with an elongated flexible component. The device includes a handle, an elongated groove and a cutter member. The cutter member has a sharp distally located cutting edge and a top surface from which a finger projects distally. The cutting edge is located under the finger and is arranged to be located within the annular space between the component and the first catheter/sheath when the first catheter/sheath is within the groove. The cutting edge serves to slice the first catheter/sheath longitudinally when the first catheter/sheath is pulled in a proximal direction. The finger protects the component from injury.

Abstract: An introducer used for access to the coronary sinus from the right subclavian vein has a body and a distal tip, a hemostatic valve, a side arm and a side arm valve coupled to the hemostatic valve. The body is coupled to valve. The introducer comprises at least one straight proximal section; and at least two curved sections with opposite curvature. The straight and curved sections collectively have a length and shape to dispose the distal tip at or near the coronary sinus when accessed from the right subclavian vein. The introducer may further comprise a straight section between the two curved sections. In another set of embodiments the proximal straight and curved sections lie in a common plane. In still another set of embodiments the curved sections lie in planes which are angularly oriented with respect to each other so that the introducer is three-dimensional.

Abstract: A pacemaker lead (18) is implanted by using a two anchor system. One anchor (916) to first secure the position of an introducer (14) through which the pacemaker lead will be implanted, and a second anchor (20) used for implanting the distal tip of the pacemaker lead (18). Examples of the anchors include various types of mechanical anchors or mechanical anchor combinations such as a suction anchor, a barbed needle, or a needle and balloon combination. The anchors can be used in the pericardial space in the heart by disposing an elongate instrument into the venous system of the heart; puncturing the venous system at a predetermined position; disposing the elongate instrument into the pericardial space at a predetermined location in the pericardial space; and implanting a pacemaker lead at the predetermined position.

Abstract: A method of exchanging vascular introducers comprises the steps of telescopically disposing a guide into a first introducer having a first inner diameter, removing the first introducer from the guide, telescopically disposing a second introducer having a second inner diameter different than the first inner diameter over the guide, and removing the guide. A kit for exchanging cardiac introducers through which a pacemaker lead has been introduced comprises a removable first introducer which is endovascularly implanted into a heart, a guide telescopically disposable into the first introducer, and a second introducer telescopically disposable over the guide to assume the position of the first introducer in the heart.