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: Apparatus, system, and methods for introducing a sharp tip of a transseptal guidewire through a hub of a transseptal needle and into a lumen of a transseptal needle are provided. The apparatus includes a holder that contains the transseptal guidewire and a shield coupled to the holder. The shield has a wall defining a lumen that accommodates the sharp tip of the transseptal guidewire. The cross-sectional shape of the wall is substantially constant along at least a portion of its length and sized to fit within the lumen of the transseptal needle, thereby inhibiting contact between the sharp tip of the transseptal guidewire and the hub of the transseptal needle when the wall of the shield is positioned to extend into the lumen of the transseptal needle. The lumen of the shield has a substantially constant cross-sectional area along at least a portion of its length and an outer surface of the wall of the shield is cylindrical along the same length.

Abstract: A balloon catheter, for use with an introducer, includes an outer catheter, a telescopically disposed resilient inner catheter and a high-aspect, distal, inflatable balloon having one end of the balloon coupled to the inner catheter and an opposing end of the balloon coupled to the outer catheter. The balloon is joined at its corresponding ends to the corresponding inner and outer catheters, so that the balloon, when inflated, buckles and twists the inner catheter inside the outer catheter. This creates forces which automatically return the balloon to the wrapped configuration when deflated. The balloon diameter to length aspect ratio is equal to or greater than 1. The balloon is wrapped around the self adjusting inner catheter extended from the outer catheter when the balloon is deflated so that the outer and inner catheters with the deflated balloon fit and are disposable through the introducer.

Abstract: A method comprises the steps of inserting a microneedle or micropuncture device into a body cavity to achieve a micropuncture into the cavity while reducing tissue trauma at a puncture site. A stepped or tapered guidewire having a reduced diameter distal portion is telescopically disposed through the inner diameter of the microneedle or Micropuncture device. A proximal portion of the guidewire has a diameter larger than the inner diameter of the microneedle or Micropuncture device and extends to a proximal end of the guidewire. The proximal portion is adapted for guiding a larger diameter instrument into and through the vascular system. The microneedle or micropuncture device is withdrawn from the micropuncture while leaving the distal portion of the guidewire extending through the micropuncture. The microneedle or micropuncture device is removed from the guidewire without removing the microneedle or Micropuncture device over the proximal end of the guidewire.

Abstract: Apparatus, system, and methods for introducing a sharp tip of a transseptal guidewire through a hub of a transseptal needle and into a lumen of a transseptal needle are provided. The apparatus includes a holder that contains the transseptal guidewire and a shield coupled to the holder. The shield has a wall defining a lumen that accommodates the sharp tip of the transseptal guidewire. The cross-sectional shape of the wall is substantially constant along at least a portion of its length and sized to fit within the lumen of the transseptal needle, thereby inhibiting contact between the sharp tip of the transseptal guidewire and the hub of the transseptal needle when the wall of the shield is positioned to extend into the lumen of the transseptal needle. The lumen of the shield has a substantially constant cross-sectional area along at least a portion of its length and an outer surface of the wall of the shield is cylindrical along the same length.

Abstract: A transseptal guidewire and methods for perforating the intra-atrial septum of the heart are disclosed. The transseptal guidewire has an elongated body with an end section and a tapered distal section. At least a portion of the end section has a first dimension in a first direction transverse to a longitudinal axis of the elongated body. The first dimension is larger than a second dimension of the portion of the end section in a second direction transverse to the longitudinal axis.

Abstract: A transseptal guidewire and methods for perforating the intra-atrial septum of the heart are disclosed. The transseptal guidewire has an elongated body, an end section biased in a curved configuration to define a proximal curve, and a distal section biased in a curved configuration to define a distal curve, the distal curve being oriented in a direction generally opposite that of the proximal curve.

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: The illustrated embodiment of the invention is directed to a sterile battery operated LED surgical light configured to be operated and manipulated during surgery attached to a surface which enters or is within a sterile field. The surgical light includes a sterile housing with a bottom surface and a front face adjacent to the bottom surface. A battery is disposed in the housing. An LED driver circuit is coupled to the battery and is disposed in the housing. At least one LED is disposed in the housing for transmitting light from the front face and is coupled to the LED circuit. A mechanism for powering the LED is disposed in the housing and is in circuit with the LED. A sterile self-adhesive backing is provided for releasably adhering to the surface within the sterile field. The backing is coupled to the housing.

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 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: The invention is a medical apparatus comprising a separable introducer, sheath, catheter, cannula, or needle, each having a wall and a length; and at least one capillary defined within the wall of a hub or along the length of the introducer, sheath, catheter, cannula, or needle to provide a corresponding zone of separation therein. The invention is also a method of separating the wall of a hub or along the length of the introducer, sheath, catheter, cannula, or needle using a capillary defined tear zone.

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: An apparatus for facilitating implantation of a pacemaker lead into the vasculature of the coronary sinus of a human heart comprises a flexible guidewire for endovascular disposition; a flexible elongate tool having at least one lumen defined therethrough for telescopic disposition of the flexible guidewire therein, the elongate tool being telescopically disposed over the flexible guidewire; and a straightening wire for telescopic disposition into the elongate tool, the straightening wire for urging the elongate tool into a more straightened shape, which is sufficiently straightened to provide increased ease of telescopic disposition of the pacemaker lead over either the first or straightening wire. In one embodiment the elongate tool includes at least two lumens defined therein to allow simultaneous telescopic disposition of the first and straightening wire therein. It is also contemplated that the elongate tool may have only lumen defined therein.

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: An introducer and hemostatic valve for improved torsional guidance and kink resistance includes an entirely circumferentially reinforced introducer connected directly to a valve body formed of a plurality of separable portions and housing a valve element in a central chamber thereof. The plurality of portions may be attached to the introducer during formation of the introducer, the valve body, or both. Alternatively, the plurality of portions may be attached to the introducer by assembly of the portions together in a surrounding relation to the introducer. In use, the plurality of portions are separated from each other and the introducer is cut along its length in order to withdraw the introducer and hemostatic valve over an enlarged proximal end of an access device as the introducer is pulled from the patient's body.

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.

Abstract: A sheath is composed of a biocompatible material which has a stiffness and moldability such that it can easily be deformed by hand by the physician prior to implantation, or by means of a guiding or shaping tool such as the dilator, stylet and or guide wire during placement within the body cavity. Similarly, it has a suppleness such that it may be molded by its disposition within the body cavity without trauma to the tissues. Yet, it has sufficient stiffness and moldability such that it retains a shape which has been imparted to it by a shaping tool when in the body cavity, even when left unsupported or unconfined in a body cavity or subject to normal bodily fluid, blood or air flow. However, once the shaping or forming tool has been removed, the sheath will tend to stay in its molded shape in a body cavity without generating a resilient force or displacement which returns it to its original shape.

Abstract: A separable hemostatic valve comprises a separable valve housing, a separable compressible valve in which an aperture is defined disposed in the valve housing, a means for varying the diameter of the aperture and/or compression of the valve around the aperture, and a means for separating the valve housing and valve into at least two parts. The means for varying the diameter of the aperture and/or compression of the valve comprises means for radially, laterally or longitudinally compressing the valve. The means for separating the valve housing and valve into at least two parts comprising means for slicing, splitting, peeling, tearing, parting or opening the valve housing and/or valve into parts.