Abstract: A vascular access device, for implantation at least partially below the skin of a patient to provide an arteriovenous fistula, includes a graft portion coupled to a catheter portion. The graft portion is sutured to an opening in an artery while the catheter portion is inserted into a vein so that its end lies within the vein downstream from the point of entry into the vein. The device may be comprised of ePTFE with an outer polyurethane coating or the graft portion may comprise ePTFE with an outer polyurethane coating and the catheter portion may comprise polyurethane. There may also be an inner polyurethane coating. Alternatively, the device may be comprised entirely of polyurethane.

Abstract: A vascular access device, for implantation at least partially below the skin of a patient to provide an arteriovenous fistula, includes a graft portion coupled to a catheter portion. The graft portion is sutured to an opening in an artery while the catheter portion is inserted into a vein so that its end lies within the vein downstream from the point of entry into the vein. The device may be comprised of ePTFE with an outer polyurethane coating or the graft portion may comprise ePTFE with an outer polyurethane coating and the catheter portion may comprise polyurethane. There may also be an inner polyurethane coating. Alternatively, the device may be comprised entirely of polyurethane.

Abstract: A catheter tip designed to reduce the outflow velocity and/or directional momentum of fluid being infused by a catheter having such a tip. In one variation, a plurality of channels is provided at the distal portion of the catheter to increase the outflow cross-sectional area. In another variation, the diameter of the catheter at its distal portion where the fluid exits is increased. In yet another variation, a bullet-shaped nose is implemented which may decrease turbulence at the distal end of catheter tip. The low velocity outflow catheter tip may also be implemented on a dual lumen catheter, such as a hemodialysis catheter, to reduce recirculation rate. Various device configurations and methods for such implementations are also disclosed.

Abstract: A system and method for measuring recirculation of blood in a catheter designed for implantation in a human is described. In one variation, the system comprises an artificial circulatory system and an ultrasonic detection device for measuring and comparing the density of a circulated blood simulant with a later introduced bolus saline. The system may be configured to simulate a human heart by providing the flow, pressure and dimensions of a typical human heart. In addition to simulating the circulatory system of a normal human heart, the system may also be configured to simulate particular negative conditions of a patient, such as stenotic condition, which would affect the recirculation measurement.

Abstract: A catheter tip designed to reduce the outflow velocity and/or directional momentum of fluid being infused by a catheter having such a tip. In one variation, a plurality of channels is provided at the distal portion of the catheter to increase the outflow cross-sectional area. In another variation, the diameter of the catheter at its distal portion where the fluid exits is increased. In yet another variation, a bullet-shaped nose is implemented which may decrease turbulence at the distal end of catheter tip. The low velocity outflow catheter tip may also be implemented on a dual lumen catheter, such as a hemodialysis catheter, to reduce recirculation rate. Various device configurations and methods for such implementations are also disclosed.

Abstract: A method of making a multi-lumen catheter includes forming a catheter body including a first lumen and a second lumen, and forming a catheter tip having a first channel terminating distally in a first opening on a first side of the catheter tip, and a second channel terminating distally in a second opening on a second side of the catheter tip opposite of the first side. The first and second openings of the catheter tip extend through an outer wall of the catheter tip to a dividing section. The catheter tip is affixed to the catheter body such that the first channel is aligned with the first lumen and the second channel is aligned with the second lumen.

Abstract: A system and method for measuring recirculation of blood in a catheter designed for implantation in a human is described. In one variation, the system comprises an artificial circulatory system and an ultrasonic detection device for measuring and comparing the density of a circulated blood simulant with a later introduced bolus saline. The system may be configured to simulate a human heart by providing the flow, pressure and dimensions of a typical human heart. In addition to simulating the circulatory system of a normal human heart, the system may also be configured to simulate particular negative conditions of a patient, such as stenotic condition, which would affect the recirculation measurement.

Abstract: A system and method for measuring recirculation of blood in a catheter designed for implantation in a human is described. In one variation, the system comprises an artificial circulatory system and an ultrasonic detection device for measuring and comparing the density of a circulated blood simulant with a later introduced bolus saline. The system may be configured to simulate a human heart by providing the flow, pressure and dimensions of a typical human heart. In addition to simulating the circulatory system of a normal human heart, the system may also be configured to simulate particular negative conditions of a patient, such as stenotic condition, which would affect the recirculation measurement.

Abstract: A catheter apparatus for delivery of fluids to and/or withdrawal of fluids from a blood vessel in a body includes a catheter having at least two lumens and a sheath attached to the proximal end of the catheter. The sheath is positionable over an entire length of the catheter while the catheter is within the blood vessel and is adapted for direct attachment to the body. The sheath may provide protective and/or sterilization functions for the multi-lumen catheter.

Abstract: Two-way, three-position and one-way, two-position slit valves in cardiovascular access catheters with closed distal ends have slit geometries configured to overcome adhesion between opposed abutting slit faces, when pressure differentials are applied between the interior and the exterior of the catheter. Portions of the slit are oriented at a non-zero angle relative to the longitudinal axis of the catheter causing shear forces to be generated in abutting slit faces. Shear forces arise from tangential, radial, or longitudinal stresses generated in the catheter body. Slit geometries are planar or curved or include multiple end-to-end connected slit subsections. If a slit partially circumscribes a portion of the adjacent outer wall of the catheter body, restraint to outward and inward movement on that portion is reduced. Slit valves are configured to open inwardly to aspirate fluids, to open outwardly to infuse fluids, or both.

Abstract: A method of making a multi-lumen catheter includes forming a catheter body including a first lumen and a second lumen, and forming a catheter tip having a first channel terminating distally in a first opening on a first side of the catheter tip, and a second channel terminating distally in a second opening on a second side of the catheter tip opposite of the first side. The first and second openings of the catheter tip extend through an outer wall of the catheter tip to a dividing section. The catheter tip is affixed to the catheter body such that the first channel is aligned with the first lumen and the second channel is aligned with the second lumen.

Abstract: Two-way, three-position and one-way, two-position slit valves in cardiovascular access catheters with closed distal ends have slit geometries configured to overcome adhesion between opposed abutting slit faces, when pressure differentials are applied between the interior and the exterior of the catheter. Portions of the slit are oriented at a non-zero angle relative to the longitudinal axis of the catheter causing shear forces to be generated in abutting slit faces. Shear forces arise from tangential, radial, or longitudinal stresses generated in the catheter body. Slit geometries are planar or curved or include multiple end-to-end connected slit subsections. If a slit partially circumscribes a portion of the adjacent outer wall of the catheter body, restraint to outward and inward movement on that portion is reduced. Slit valves are configured to open inwardly to aspirate fluids, to open outwardly to infuse fluids, or both.

Abstract: A bolus tip for a multi-lumen catheter includes a first channel terminating distally in a first opening, and a second channel terminating distally in a second opening. The first opening may be positioned proximal the second opening along a longitudinal axis of the bolus tip and may be positioned on a side of the bolus tip opposite that of the second opening. The first and second openings may extend through an outer wall of the bolus tip to a dividing section. The bolus tip may also include a third channel sized for accommodating a guidewire.

Abstract: A fully integrated, independently accurately performing, active transdermal medicament patch includes a flexible substrate with an adhesive-coated therapeutic face carrying a medicament reservoir. A circuit non-removably carried on the substrate and driven by a light-weight power source causes a substantially constant current to flow for a predetermined therapy period through the reservoir and the skin against which the therapeutic face is disposed. Net electrical polarity of the medicament determines the interconnection of circuit and power source to skin. The circuit includes a field effect transistor or an operational amplifier with a zener diode or a voltage regulator. A timer non-removably carried on the substrate disables the circuit following functioning the therapy period. An active transdermal medicament delivery system employs a single patch or pair of patches physically and electrically connected by a distensible tether.

Abstract: Catheter valve assemblies and methods for connecting catheters and/or providing fluid access to catheters. In one variation, a device comprises a catheter valve assembly and an extension leg unit. The extension leg unit includes lumen inserts for engaging valves positioned within the catheter valve assembly. In another variation, the valve assembly comprises a depressable plunger which may be engaged by an access cannula. Various connectors with integrated valve assemblies are also disclosed.

Abstract: A bolus tip for a multi-lumen catheter includes a first channel terminating distally in a first opening, and a second channel terminating distally in a second opening. The first opening may be positioned proximal the second opening along a longitudinal axis of the bolus tip and may be positioned on a side of the bolus tip opposite that of the second opening. The first and second openings may extend through an outer wall of the bolus tip to a dividing section. The bolus tip may also include a third channel sized for accommodating a guidewire.

Abstract: An improved bolus tip design for use in a multi-lumen catheter for the simultaneous injection and withdrawal of fluids to and from a patient. The improved bolus tip has a rounded elongate body consisting of an interfacing section and a nose section. A first channel opens to a first bolus cavity, which is formed into the bolus tip, and a second channel either extends through the nose section of the bolus tip, forming an outlet therefrom, or terminates at a second bolus cavity similar to the first bolus cavity. In the latter configuration, the second bolus cavity is located longitudinally between the fist bolus cavity and a tip of the nose section on a side directly opposite the first bolus cavity. The second bolus cavity is in fluid communication with the second channel.