Abstract: A self-sealing vascular graft with kink resistance is described. The vascular graft includes a substrate that can be ePTFE, having a self-sealing region that may include several layers of material. The central section of the vascular graft may be constructed differently from surrounding self-sealing regions, in order to provide kink resistance following the clamping of the graft. Also described is a graft with a flared cuff attached to one or both ends, the attachment or transition region including reinforcement beading.

Abstract: A guidance system for assisting with the insertion of a needle into a patient is disclosed. The guidance system utilizes ultrasound imaging or other suitable imaging technology. In one embodiment, the guidance system comprises an imaging device including a probe for producing an image of an internal body target, such as a vessel. One or more sensors are included with the probe. The sensors sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle. The system includes a processor that uses data relating to the sensed characteristic to determine a 3-D position of the needle. The system includes a display for depicting the position of the needle. A needle assembly including a hub, cannula, and magnetic element is also disclosed, wherein a magnetic axis of the magnetic element is configured to be coaxially or otherwise aligned with the needle cannula.

Abstract: A helical stent having bio-resorbable connecting members connecting sections of the stent. The connecting members provide various spring rates or spring constants to the stent, and permit a change in the flexibility of the stent subsequent to implantation while maintaining the unitary design of the stent.

Abstract: A radially expansible annular stent is disclosed. The stent comprises a plurality of stenting turns around a lumen centred on a longitudinal axis. Adjacent turns of the stent are joined by connector struts. The stent annulus has a wall thickness related to the material from which it is formed. The radial thickness of the connector struts is smaller than that of the stent annulus. A method of making such a stent is also disclosed. The method includes cutting the connector struts from a tubular workpiece with a laser beam. The laser beam is aimed so as to be offset from a longitudinal axis of the workpiece to provide the reduced radial thickness of the connector struts.

Abstract: A drainage catheter including a body, a drainage lumen extending between the body proximal end and the body distal end, the drainage lumen including a distal fluid inflow port and a proximal fluid drain coupling, and an inflation lumen extending between the body proximal end and the body distal end, conveying inflating fluid from a proximal fluid supply element to a distal fluid acceptor balloon, the proximal fluid supply element adjacent the proximal fluid drain coupling. A sleeve may be secured about the proximal fluid supply element and the proximal fluid drain coupling to provide a fluid impervious coating.

Abstract: An assembly for identifying a power injectable vascular access port, including a vascular access port and an identification feature. The port is structured for power injection and includes a housing and a septum together defining a reservoir. A radiographic feature incorporated into the port is perceivable via x-ray following subcutaneous implantation, the radiographic feature identifying the port as suitable for flowing fluid at a fluid flow rate of at least 1 mL/sec therethrough. A structural feature of the port is perceivable via palpation following subcutaneous implantation, the structural feature identifying the port as suitable for accommodating a pressure within the reservoir of at least 35 psi. The identification feature is separated from the port and confirms that the port is both suitable for flowing fluid at a rate of at least 1 mL/sec therethrough and suitable for accommodating a pressure within the reservoir of at least 35 psi.

Abstract: Disclosed herein is a system for transferring brachytherapy elements to a needle, such as seeds, connectors, spacers, and strands. The system comprises a transfer device and, optionally, a stylet and a rack configured to hold one or more transfer devices.

Abstract: An exemplary infusion system for accessing an implanted device is disclosed comprising an insertion assembly, a hub comprising a sealable path configured to receive at least a portion of the insertion assembly, a flexible catheter attached to the hub and configured to receive at least a portion of the insertion assembly, and an extension tube attached to the hub. The hub may comprise a manifold element configured to provide fluid communication between the flexible catheter and the extension tube. The hub may also comprise a septum configured to seal the sealable path upon removal of the insertion assembly from the flexible catheter. The extension tube may also be configured to receive at least a portion of the insertion assembly. Exemplary methods of providing a fluid communication path to an implanted device are also disclosed.

Abstract: An insertion tool for inserting a catheter into a body of a patient is disclosed. The insertion tool unifies needle insertion, guidewire advancement, and catheter insertion in a single device. In one embodiment, the insertion tool comprises a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing with at least a portion of the catheter pre-disposed over the needle, and a guidewire pre-disposed within the needle. A guidewire advancement assembly is also included for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. In one embodiment a catheter advancement assembly is also included for selectively advancing the catheter into the patient. Each advancement assembly can include a slide or other actuator that enables a user to selectively advance the desired component.

Abstract: A graft device comprising a layer of synthetic non-metallic material having a first surface and a second surface spaced apart from the first surface. The device further, includes a radiopaque marker at least partially embedded in the layer.

Abstract: A catheter assembly includes a catheter, a tubular structure affixed to an exterior surface of the catheter, and a stabilizing cuff affixed to, and at least partially embedded within, the tubular structure. The tubular structure may include a tapered surface extending from an end of the tubular structure to an exterior surface of the catheter. A method of manufacturing a catheter assembly may include positioning a tubular structure about a catheter, positioning a stabilizing cuff near the tubular structure, and partially embedding at least a portion of the stabilizing cuff within the tubular structure while shaping the tubular structure to form a tapered surface. A temporary sleeve may be positioned about the tubular structure prior to shaping the tubular structure. The tubular structure may also be preformed to include a tapered end prior to positioning the tubular structure about the catheter.

Abstract: A split-tip catheter for placement within the vasculature of a patient and for use in hemodialysis or other suitable procedures is disclosed. In one embodiment, the split-tip catheter includes a catheter body that defines a first lumen and a second lumen. The catheter body further comprises a split distal region, including a venous segment and an arterial segment. The venous segment includes a recess extending proximally of a nose portion; and a lateral opening in fluid communication with the first lumen. The arterial segment also includes a lateral opening, is separate from the venous segment, and is removably seatable in the recess provided by the venous segment. In one embodiment, the distal region is un-split, but includes symmetrically opposed lateral openings, as well as distal openings, in communication with the first and second lumens for providing a functional stagger for blood flow in both forward and reverse catheter flow directions.

Abstract: Implantable prostheses for reinforcing and repairing defects in a muscular or tissue wall and a method for fabricating the prostheses that minimizes wasted mesh material and reduces the labor and time required for fabrication. The prosthesis may include a plug body formed of surgical mesh material having a closed end, a larger open end, and a cavity extending therebetween, and a filler body formed of the surgical mesh material comprising a plurality of petals extending radially outwardly from and spaced laterally about a common base disposed in the plug body with the common base attached to the closed end of the plug body. The plug bodies are cut as circular pieces, and the filler bodies are cut as hour-glass shaped pieces from the same sheet of material so as to leave virtually no wasted mesh material. The filler pieces may be attached to the plug body piece by welding.

Abstract: An indwelling urinary drainage catheter (12, 110) includes synthetic polyisoprene rubber (SPIR). Advantageously, the SPIR catheter can meet the tensile and resiliency requirements of Foley applications while avoiding the risk of allergic reactions in sensitive patients. The SPIR comprises an accelerator system that uses a carbamate as the only accelerator, a guanidine as the only accelerator, a combination of guanidine and carbamate accelerators, a combination of carbamate and thiazole accelerators, or a combination of guanidine, carbamate and thiazole accelerators.

Abstract: A demonstration mannequin for simulating insertion of a catheter or other medical device into the body of a patient is disclosed. The mannequin is useful for training clinicians in the placement of a catheter into the patient's vasculature and includes the ability to provide a malposition scenario in which the catheter is deviated from an intended path within the vasculature, resulting in a simulated malposition thereof. In one embodiment, the mannequin comprises a torso body portion and a simulated vasculature disposed within the body. The simulated vasculature is accessible by a medical device, such as a catheter, which can be advanced within the simulated vasculature. The mannequin further includes at least one diversion element that selectively obstructs a portion of the simulated vasculature to block advancement of a distal end of the catheter along an intended path and instead causes diversion of the catheter, thus simulating a catheter malposition scenario.

Abstract: A method of treating a patient includes providing an implantable vessel filter including a plurality of legs and a center-post, inserting the filter into a delivery assembly, and deploying the filter at a desired location in a patient's body. One or more of the legs may have a hook at a distal end thereof and the center-post includes a grooved distal section to receive the hooks. The filter legs transition from a compressed configuration to an expanded configuration during deployment.

Abstract: An embolus filter introducer system has a symmetric introducer sheath with a filter inside. The introducer sheath can be attached at either end to a deployment actuator. The deployment actuator can thereby be used to push the filter out of the introducer sheath. Since the sheath can be oriented in a selectable direction, so can the filter, allowing the sheath to be introduced via a jugular or femoral approach to the vena cava.

Abstract: A medical balloon with a variable diameter that is reinforced with continuous fibers woven to form a fabric with a varying number of layers and fiber densities. Portions of the balloon having a relatively smaller diameter are reinforced with a fabric having a reduced fiber density and an increased number of layers to facilitate the placement of the layers. The fabric also includes a braiding pattern that facilitates the transition from a single layer fabric to a multiple layer fabric. Also described is a manufacturing method for the braiding and layering.

Abstract: A catheter connection system and a method of connecting the catheter connection system to a catheter. The catheter connection system includes a hub assembly and a collar. The hub assembly includes a cannula extending from a distal end thereof, and a collet defining an inner surface spaced apart from the cannula to permit passage of a catheter wall between the body and the cannula.