摘要:
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.
摘要:
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.
摘要:
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 (16) having a first shape or bias along a portion. The first shape on the outer element may be pre-biased or may be initially straight and subsequently biased once deployed in the body chamber. A flexible, elongate, telescopic inner elongate element (14) 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 (14) is telescopically disposed in the outer sheath. The outer and inner elongate elements are rotatable with respect to each other, such that when the inner elongate element (14) is distally extended from the outer sheath (16), there exists an angular orientation between the inner and outer sheaths which is congruent, when there is at least partial alignment between the distal portion of the outer elongate element and the more proximal portion of the inner sheath (14), both having the first shape or bias.
摘要:
Device for performing a transseptal puncture procedure using a device which includes either an untapered or tapered blunt end cannula (39) disposed in an introducer (57) carrying a sharp guidewire (59) disposed longitudinally through the lumen of the blunt cannula, and a blunt end dilator (55) 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.
摘要:
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.
摘要:
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.
摘要:
An introducer system (10) 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 (12), a precurved inner telescoping sheath (14), and an outer telescoping sheath (16), introducer, guide or catheter (10). A core (12) is used it is torsionally stiff. In an embodiment where no core is used, the inner sheath (14) is torsionally stiff. In either case, the member which is torsionally stiff is torqueable. In general, the inner sheath (14) and outer guide (16) will be both laterally and torsionally flexible, while the core (12) will be torsionally stiff. The core (12) and the inner sheath (14), 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 (14).
摘要:
A transseptal guidewire (220) for perforating the intra-atrial septum of the heart are disclosed. The transseptal guidewire has an elongated body (222), an end section biased (226) in a curved configuration to define a proximal curve (226a), and a distal section (228) biased in a curved configuration to define a distal curve (228a), the distal curve being oriented in a direction generally opposite that of the proximal curve and the proximal and distal curves occupy the same plane.
摘要:
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.