Abstract: A needle or stylet has a tip contour with a reverse back bevel curved toward the longitudinal axis of the needle or stylet. The needle has a flexible intermediate portion and/or a two-part construction in which a distal portion of the needle to crimped onto a proximal portion of the needle. The needle or a stylet is combined with a spring mechanism in the hub of the needle or stylet assembly. The spring mechanism positions the tip of the needle or stylet in a middle position extending from the distal end of the assembly, allows the needle or stylet to be moved into a spring loaded fully retracted configuration within the assembly as the septal wall is tented, and then releasing the spring loaded needle or stylet as the needle or stylet penetrates the septal wall. A method of using a needle or stylet with a spring mechanism is included.

Abstract: A needle or stylet has a tip contour with a reverse back bevel curved toward the longitudinal axis of the needle or stylet. The needle has a flexible intermediate portion and/or a two-part construction in which a distal portion of the needle to crimped onto a proximal portion of the needle. The needle or a stylet is combined with a spring mechanism in the hub of the needle or stylet assembly. The spring mechanism positions the tip of the needle or stylet in a middle position extending from the distal end of the assembly, allows the needle or stylet to be moved into a spring loaded fully retracted configuration within the assembly as the septal wall is tented, and then releasing the spring loaded needle or stylet as the needle or stylet penetrates the septal wall. A method of using a needle or stylet with a spring mechanism is included.

Abstract: A needle or stylet has a tip contour with a reverse back bevel curved toward the longitudinal axis of the needle or stylet. The needle has a flexible intermediate portion and/or a two-part construction in which a distal portion of the needle to crimped onto a proximal portion of the needle. The needle or a stylet is combined with a spring mechanism in the hub of the needle or stylet assembly. The spring mechanism positions the tip of the needle or stylet in a middle position extending from the distal end of the assembly, allows the needle or stylet to be moved into a spring loaded fully retracted configuration within the assembly as the septal wall is tented, and then releasing the spring loaded needle or stylet as the needle or stylet penetrates the septal wall. A method of using a needle or stylet with a spring mechanism is included.

Abstract: Devices and methods for performing a transseptal puncture procedure using a device which includes either an untapered or tapered blunt end cannula disposed in an introducer carrying a sharp guidewire disposed longitudinally through the lumen of the blunt cannula, and a blunt end dilator wherein the guidewire is flexible and has an atraumatic shape at its tip. The cannula gives the more flexible introducer a defined shape and steerabilty allowing an ordinarily skilled physician to easily access a selected location on the septal wall of the heart for transseptal puncture and introducer placement thereacross without employing an exposed sharp end needle during the procedure.

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: 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: Devices and methods for performing a transeptal puncture procedure are described. In certain embodiments, the device includes a blunt outer needle, and a second inner needle disposed longitudinally through the lumen of the outer needle, wherein the inner needle is flexible, e.g., has a flexible portion and/or a bend or other non-traumatic conformation at its tip.

Abstract: The invention includes a universal transvalvular insertion tool for providing a passage through a multiplicity of differently designed hemostatically valved introducers, each having a valve within a valved body coupled to a cardiac introducer. The tool includes a longitudinally rigid sheath having a lumen and for insertion through the valve of any one of the multiplicity of differently designed hemostatically valved introducers to provide a substantially obstruction free path for delivery of a lead or vascular device through the valve and valved body to the introducer, the sheath having a length selected to extend through the valve without substantial deformation of the lumen of the sheath. A mechanism is provided for separating the rigid sheath to allow removal from the lead or device without removal of the transvalvular insertion tool over either end of the lead or vascular device.

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: Apparatus, systems, and methods for forming a hole in biological material, such as tissue walls, adjacent vessels or adjacent regions of an organ such that access to opposing surfaces of the biological material can be achieved. In general overview the system may include an elongate member for positioning and deploying a flexible member in the heart. In one embodiment apparatus and methods are provided for aligning and fixing the position of the tip of a cutting member for cutting a hole in the septal wall of a heart. In another embodiment, subsequent to cutting a tissue wall an apparatus for obstructing holes in the septal wall is inserted to limit the flow of blood through a plurality of holes in a tissue wall.

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: Devices and methods for performing a transeptal puncture procedure are described. In certain embodiments, the device includes a blunt outer needle, and a second inner needle disposed longitudinally through the lumen of the outer needle, wherein the inner needle is flexible, e.g., has a flexible portion and/or a bend or other non-traumatic conformation at its tip.

Abstract: Devices and methods for performing a transeptal puncture procedure are described. In certain embodiments, the device includes a blunt outer needle, and a second inner needle disposed longitudinally through the lumen of the outer needle, wherein the inner needle is flexible, e.g., has a flexible portion and/or a bend or other non-traumatic conformation at its tip.

Abstract: Devices and methods for performing a transeptal puncture procedure are described. In certain embodiments, the device includes a blunt outer needle, and a second inner needle disposed longitudinally through the lumen of the outer needle, wherein the inner needle is flexible, e.g., has a flexible portion and/or a bend or other non-traumatic conformation at its tip.

Abstract: An adapter for an introducer comprises a medical device having a tubular port on a proximal end such as a splittable hemostatic valve. A tubular fitting is provided on a proximal end of the introducer. An elastomeric member is disposed between the port of the medical device and the tubular fitting of the introducer for providing a fluid tight and mechanically secure connection therebetween. The introducer and valve are manually connectable and reconnectable with each other while maintaining the fluid tight connection between them. A side port may communicate with the hemostatic valve, the side port having a controllable valve ending. In the preferred embodiment the introducer comprises a splittable introducer. In the illustrated embodiment the elastomeric member provides a slip fit between the medical device and the tubular fitting of the introducer. A tab extends from the tubular fitting of the introducer to facilitate manual manipulation of the tubular fitting.

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.