Abstract: Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism's reaction to the introduction of the medical device to the organism. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

Abstract: An implantable microporous ePTFE tubular vascular graft exhibits long term patency, superior radial tensile strength and suture hole elongation resistance. The graft includes a first ePTFE tube and a second ePTFE tube circumferentially disposed over the first tube. The first ePTFE tube exhibits a porosity sufficient to promote cell endothelization, tissue ingrowth and healing. The second ePTFE tube exhibits enhanced radial strength in excess of the radial tensile strength of the first tube.

Abstract: A seat restraint configured to be secured to an anchoring tube includes at least one anchoring tube engaging member, and at least one fastening member integrally formed with the at least one anchoring tube engaging member.

Abstract: An embolic protection device includes a basket defined by a section of a set of wires arranged as a plurality of struts. These struts are coupled together at their distal ends as well as to the distal end of a core wire or mandrel. Another section of the wires spirals around the core wire to define a hollow channel in which the core wire can reciprocate. Thus, pulling or pushing a proximal end of the core wire relative to the struts expands or contracts the basket. A filter bag is attached to the basket for capturing clots when the basket is in an expanded configuration.

Abstract: An embolic protection device includes a basket defined by a section of a set of wires arranged as a plurality of struts. These struts are coupled together at the distal end of the basket in a manner to define an opening at the distal end through which a core wire can reciprocate. Another section of the wires spirals around the core wire to define a hollow channel in which the core wire can reciprocate. A filter bag is attached to the distal end of the core wire such that pulling a proximal end of the core wire relative to the spiraled section engages the filter bag with the distal end of the basket to expand the basket and filter bag for capturing clots, and pushing the core wire disengages the filter bag from the distal end of the basket to collapse the basket and filter bag.

Abstract: The medical device includes a secondary wire guide and an advancement device. The advancement device has a tubular portion with a distal opening and a proximal opening. An edge region of the tubular portion forms the distal opening. A primary wire guide extends through the tubular portion. The secondary wire guide also extends into the tubular portion and has a distal portion configured to engage the edge region of the tubular portion. Accordingly, the secondary wire guide is advanced as the advancement device is translated into the blood vessel.

Abstract: Delivery systems for self-expanding devices are provided having a system proximal portion with a handle, an elongate middle section delivery device with an outer sheath and inner compression member, and a system distal portion including an outer guide channel member with first and second end portions defining a guide channel that slidably receives an inner guide channel member having a guide channel, the guide channels being substantially aligned. A mounting region for self-expanding devices is disposed radially between the inner and outer guide channel members. The outer guide channel member has a stepped profile from a first outer diameter to a second smaller outer diameter located near a transition region having a breech position opening for passage of a wire guide, catheter, or other medical instrument. The outer member is axially slideable relative to the inner member to deploy a self-expanding device. Methods of using and manufacturing are also provided.

Abstract: Local drug delivery medical devices are utilized to deliver therapeutic dosages of drugs, agents or compounds directly to the site where needed. The local drug delivery medical devices utilize various materials and coating methodologies to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

Abstract: Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism's reaction to the introduction of the medical device to the organism. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

Abstract: A catheter device including an elongate tubular shaft having a consistent material composition for a substantial proportion of its length. The device includes a proximal shaft portion having a first flexibility and a distal shaft portion having a second flexibility, wherein the second flexibility is greater than the first flexibility and wherein at least the distal shaft portion comprises at least one score in a surface thereof.

Abstract: An implantable intraluminal device includes a multilayer composite tubular device supporting one or more stents between the layer thereof. A first porous elongate tube includes an exterior surface and an interior luminal surface. A radially expandable member is disposed about the exterior surface of the first tube. A second porous elongate tube is disposed concentrically over the first tube and is secured thereto so that the radially expandable member is longitudinally immobilized therebetween.

Abstract: A method for effectively cryoablating tissue cells includes a regimen of selected cooling and warming rates. Specifically, cells are typically ablated by first cooling the cells at a relatively fast cooling rate (e.g. greater than 200° C. per minute) to reduce the cell temperature to below a minimum temperature (e.g. minus 10-15° C.) required to cause the cells to freeze. Next, the cells are thawed using a controlled, relatively slow warming rate (e.g. less than 100° C. per minute). The relatively fast cooling rate can cause intracellular and extra-cellular freezing of the tissue cells and the formation of relatively small ice crystals. Subsequently, during warming at a relatively slow warming rate, the small ice crystals can recrystallize and grow, causing a relatively high rate of cell destruction.

Abstract: A bioresorbable sealant composition useful for impregnating implantable soft-tissue prostheses includes at least two polysaccharides in combination to form a hydrogel or sol-gel. The sealant compositions may optionally include a bioactive agent and/or be cross-linked subsequent to application of these compositions to the substrate surface.

Abstract: A catheter device including an elongate catheter shaft comprising a multifilar cable tubing having a proximal portion and a distal portion. At least a part of the distal portion is more flexible than the proximal portion.

Abstract: An articulating segment for a catheter includes a tube shaped member that is formed with a helical cut around the tube's axis. The cut extends through the member, between its outer and inner surfaces, and defines a pitch angle with the axis that can be varied according to the desired flexibility of the segment. A flexible coating is positioned on the outer surface of the tube to cover the helical cut and to provide a fluid-tight condition during articulation of the segment.

Abstract: A bi-directional system for actively deflecting the distal tip of a catheter includes a reconfigurable tube that is positioned proximal to the catheter's distal tip. The tube is formed with slits that are arranged to allow the tube to be transformed from a relaxed, cylindrical configuration to a plurality of deflected configurations. First and second pull wires are provided, with each wire having a respective distal end that is attached to the distal end of the tube. Each wire extends to a catheter handle where it is attached to a respective reel. The reels can be rotated, back and forth, to selectively deflect or relax the tube. To ensure a smooth recovery after a relatively large deflection, a mechanism is disclosed for delaying an application of tension on one of the pull wires until at least a portion of any tension on the other pull wire is released.

Abstract: An active system for deflecting a distal portion of a catheter into a hoop configuration includes an elongated catheter body having a proximal portion and a distal portion that is formed with a lumen. A thin-walled tube, which is typically made of a metallic material, is positioned in the lumen. The tube includes a cylindrical wall and includes a plurality of lateral slits that are typically formed in the tube wall and arranged such that the tube can be transformed between a relaxed, cylindrical configuration and a deflected configuration wherein the tube is substantially hoop shaped. One end of a deflection wire is attached to the tube and the other wire end is attached to a reel that is rotationally mounted onto a catheter handle housing. In use, the reel is rotated to axially retract the wire and transform the tube into a hoop configuration.

Abstract: A cryoablation device having a pressure monitoring system includes an elongated catheter tube that has a central lumen and is formed with a closed distal end. The distal end of a refrigerant supply line is positioned in the central lumen and distanced from the catheter tube's distal end to establish an expansion chamber therebetween. A return line, which can be established between the supply line and the catheter tube or can include a return tube, is provided to exhaust expanded refrigerant from the chamber. First and second pressure sensors are respectively positioned in the supply line upstream from the expansion chamber and in the return line. Typically, both sensors are positioned to remain at extracorporeal locations throughout a cryoablation procedure. Measured pressures are used together with the supply and return line dimensions to analytically estimate the chamber pressure and allow the expansion of refrigerant in the chamber to be monitored.

Abstract: An introducer sheath includes an elongated hollow hypotube that is formed with a spiral cut that extends between the ends of the hypotube and extends through the hypotube from its outer surface to its inner surface. During manufacture, the spiral cut is made with a pitch angle (?) that can be varied along the length of the hypotube to provide different sections of the hypotube with different degrees of flexibility. A polymer coating is positioned on the outer surface of the hypotube to establish a lubricious coating for the introducer sheath.

Abstract: A system and method for cryoablating tissue at a target site in a patient includes a cryotip attached to the distal end of a catheter tube. The cryotip is made of a shape memory material that assumes a straight configuration at a first temperature and a coiled configuration at a second temperature. With the cryotip in the straight configuration, the cryotip is guided through the vasculature of a patient to the target site. A refrigerant fluid is introduced into the expansion chamber of the cryotip to cool the cryotip to the second temperature. At the second temperature, the cryotip transforms into the coiled configuration and is placed in contact with circumferential tissue around the target site. The circumferential tissue is then cryoablated in a single-step operation.