Abstract: The present invention provides for exemplary embodiments of a single-insertion, multiple sampling biopsy device. Exemplary embodiments of a single-insertion, multiple sampling device with integrated marker release.

Abstract: An instrument for delivering a suture transfascially may include a handle, a shaft extending from the handle, and at least one needle that is moveable to an extended position beyond the end of the shaft. A suture may be delivered transfascially with the instrument. The instrument may include a suture catch associated with each needle for retaining and releasing a suture segment. A shield may be provided to shield the sharp end of each needle when it is moved to the extended position. A method of delivering a transfascial suture may include inserting an instrument into an abdominal cavity and deploying, from within the abdominal cavity, each needle through a soft tissue repair patch and then through at least part of the abdominal wall. A suture or suture segment may be advanced across the fascia with the at least one needle.

Abstract: A device to release from an implant bed in the device a self-expanding implant by pulling back proximally, the length of the implant, a rolling membrane with an inner sleeve that extends distally to the distal end of the implant and an outer sleeve that extends proximally, from the distal end of the inner sleeve, the outer sleeve, during said release, pulling the distal end of the inner sleeve back proximally over the abluminal surface of the remainder of the inner sleeve, proximal of its distal end, the device having a slitter, that is caused to move proximally contemporaneously with the outer sleeve, to slit the inner sleeve progressively, starting at a distal point in the inner sleeve, and progressing proximally along the length of the inner sleeve.

Abstract: A method of moving a stent device into an outer sheath of a stent device delivery system is disclosed. The stent device is crimped into a collapsed configuration onto the loading mandrel. The loading mandrel is pushed toward the outer sheath as the engaging surfaces resist relative longitudinal movement between the stent device and the loading mandrel to move the stent device into the outer sheath. Upon entering the outer sheath, the stent device expands radially until radially constrained by the outer sheath.

Abstract: An elongated medical device includes a core element, a polymer member, a closure element, and a permanent magnetic element. The core element may have a distal region including a first region with a diameter greater than a diameter of a second region, the second region distal of the first region and terminating at a core element distal end. The polymer member may be circumferentially disposed about an entire length of the core element and extending distal of the core element distal end. The closure element may be affixed to a distal end of the polymer member. The permanent magnetic element may be disposed along the second region proximal to the core element distal end, and may include a plurality of permanent magnetic elements spaced apart along the second region.

Abstract: Disclosed herein are a method and a medical system for utilizing of an intravascular ECG signal for central venous catheter placement. The medical system is capable of detecting the position of a catheter tip and assessing its location relative to the cavoatrial junction. The detection and assessment are performed by a multiscale analysis of the complexity of the intravascular signal data points.

Abstract: An integrated catheter placement system for accurately placing a catheter within a patient's vasculature is disclosed. In one embodiment, the integrated system comprises a system console, a tip location sensor for temporary placement on the patient's chest, and an ultrasound probe. The tip location sensor senses a magnetic field of a stylet disposed in a lumen of the catheter when the catheter is disposed in the vasculature. The ultrasound probe ultrasonically images a portion of the vasculature prior to intravascular introduction of the catheter. The ultrasound probe includes user input controls for controlling use of the ultrasound probe in an ultrasound mode and use of the tip location sensor in a tip location mode. In another embodiment, ECG signal-based catheter tip guidance is included in the integrated system to enable guidance of the catheter tip to a desired position with respect to a node of the patient's heart.

Abstract: A securement system for anchoring a medical article to a patient includes a pliant holding device. The device has a body and a plurality of tentacles extending from the body. The tentacles compress and may conform around at least a portion of the medical article to form a secure mount. The holding device may also cushion the medical article and protect the site of attachment on the patient while promoting air circulation. The holding device may include a support and a hinge so that the holding device may be swung away from the medical article to provide easy access for a medical provider.

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: The invention relates to a balloon catheter comprising a catheter tube, an inflatable balloon, the ends of which are attached to the catheter tube, and a stent attached around the balloon. The stent extends at least partly along the length of the balloon. In an uninflated state, at least the outside surface of the balloon not covered by the stent is provided with a relief structure which is substantially disappeared in an inflated state of the balloon. The invention also relates to a method for manufacturing such a balloon catheter.

Abstract: An elongate open-bored applicator (EOBP) adapted to deploy a mesh comprising (a) at least one inflatable contour-balloon, (b) at least one inflatable dissection balloon. The inflatable contour-balloon and the inflatable dissection balloon are adjustable and located at the distal portion; and, (c) at least one actuating means located at the proximal portion. The actuating means is in communication with the inflatable contour-balloon and the inflatable dissection balloon. The actuating means is adapted to provide the inflatable contour-balloon and the inflatable dissection balloon with independent activation and/or de-activation.

Abstract: A vena cava filter is described, having one or more frame members or an elongated member arranged in helical fashion. A plurality of filaments connect frame members or portions of the elongated member. The filaments may be made of suture material. Hooks may be placed on a free end of the filaments, along the length thereof, or on one or more frame members to engage the blood vessel wall and anchor the filter. A retrieval member may be positioned on the filter to facilitate withdrawal of the filter from the blood vessel.

Abstract: A cannula arrangement includes an inner tube disposed within an outer tube. A flexible sealing element is connected to a proximal portion of the outer tube. The flexible sealing element has a longitudinal axis coaxial with the outer tube. The flexible sealing element has a cantilevered portion that longitudinally extends a longitudinal distance parallel to the longitudinal axis in a proximal direction from the proximal end of the outer tube. The cantilevered portion has a projecting portion that projects diagonally toward the inner tube to define an interior edge to contact an outer surface of the inner tube.

Abstract: A needle guide assembly for inserting a needle into the body of a patient in order to access a subcutaneous target, such as a vessel, is disclosed. In one embodiment, the needle guide assembly comprises a needle guide body that is configured to at least indirectly and removably attach to an image producing device, such as an ultrasound probe. The needle guide body defines at least first and second elongate guide channels. Each guide channel defines a unique insertion angle with respect to a longitudinal axis of the ultrasound probe. Further, each guide channel is configured to accept needles of differing gauges.

Abstract: A biopsy device includes a cutting cannula mechanism having a cutting cannula and an inner stylet mechanism having an inner stylet coaxial with the cutting cannula. A cocking mechanism is configured to cock the cutting cannula mechanism and the inner stylet mechanism by retracting each of the cutting cannula and the inner stylet in a proximal direction to a cocked position. A trigger device is configured to fire at least one of the inner stylet mechanism and the cutting cannula mechanism to advance a respective at least one of the inner stylet and the cutting cannula from the cocked position in a distal direction. A selector assembly includes a selector switch having an exterior tab accessible by a user. The selector assembly is configured to select between at least two user selectable operating modes and at least two user selectable firing distances.

Abstract: A guidance system for assisting with the insertion of a needle into a patient body 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 portion 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 the cannula is substantially non-magnetic so as to not distort the magnetic field of the magnetic element.

Abstract: A tubular prosthesis having a succession of turns around a longitudinal axis includes connectors between adjacent turns distributed around the circumference of the prosthesis. Each turn includes struts interspersed by inflection zones located at the axial ends of each turn such that, when the prosthesis expands radially, gaps open up between adjacent struts of each of the turn. The inflection zones are distributed regularly around the circumference so that the gaps are substantially the same size as each other around the circumference of the turn. The prosthesis may include a turn that exhibits a stagger zone within which the gap between adjacent struts is of an individual size different from that common to the other gaps of that turn. The inflection zones in that turn that lie circumferentially next to the stagger zone are displaced out of facing relationship with corresponding zones of inflection in the adjacent turn.

Abstract: Systems and methods for assisting the placement of a catheter within the body of a patient through the use of an ultrasound imaging system are disclosed. In particular, the systems and methods described herein enable a clinician to determine, prior to insertion of the medical device, how much of the device will be disposed within the vessel, thus enabling the clinician to choose a catheter with suitable length. In one embodiment, an ultrasound imaging system for assisting with placement of the medical device comprises a console, a probe for producing an image of a target location, and a processor. The processor provides to a user proximity information relating to the anticipated proximity of the medical device to the target location prior to insertion of the medical device. A display is included for depicting the image, target location depth, and the proximity information of the medical device to the target location.

Abstract: A sacrificial catheter assembly and method of use for placing a functional catheter within the body of a patient, such as into the patient's vasculature, is disclosed. In one embodiment, the sacrificial catheter assembly comprises a sacrificial catheter including an elongate body that defines a longitudinally extending lumen. A stylet is removably received within the lumen of the sacrificial catheter such that the catheter and stylet can be advanced together to a target destination within the body of the patient. The sacrificial catheter is configured so as to then be proximally slid over the stylet to remove the sacrificial catheter from the body while the stylet remains in place at the target destination. A functional catheter can then be distally slid over the stylet to place the functional catheter at the target destination. The stylet can then be removed from the body of the patient.