Abstract: A method of treating lower leg ischemia includes advancing a wire guide upstream through a vascular access sheath extending into an artery, and increasing a downstream flow of blood at least in part by dilating a constriction in the artery with a treatment mechanism guided into the constriction via the wire guide. The method further includes withdrawing a catheter which is coupled with the treatment mechanism from the patient at the percutaneous entry point via sliding the catheter downstream through the vascular access sheath. A low profile balloon may be used as the treatment mechanism, and is advanced through the artery while the vascular access sheath protects the artery from irritation such that spasm of the artery is less likely to occur. Reduced risk of spasm advantageously enables retrograde access to chronic total occlusions such that multiple entry points into a patient's body are not necessary.

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: Catheter balloon assemblies (10) for delivering a therapeutic agent to a body vessel are provided, as well as related methods of manufacturing and methods of treatment. The catheter balloon assemblies may include a concentrically disposed dual balloon assembly at the distal portion of the catheter having an inner balloon (44), a porous outer balloon (42) concentrically arrayed around the inner balloon and a catheter shaft (30) adapted to deliver a therapeutic agent to the body vessel through the apertures in the outer balloon. Radial outward expansion of the inner balloon may urge the outer balloon into contact with the wall of a body vessel, where the therapeutic agent may be delivered from the catheter shaft through apertures in the outer balloon directly to the wall of the body vessel.

Abstract: A medical balloon catheter including a shaft comprised of a cross-wound coil tube and a sleeve surrounding the cross-wound coil tube. The cross-wound coil tube includes a monofilament inner coil disposed within a monofilament outer coil. The inner and outer coils are wound in opposite pitch directions. In at least one embodiment, at least one of the inner and outer coils includes a tapered distal section having a tapered diameter. In at least another embodiment, the inner coil extends distally beyond the distal end of the outer coil, providing increased flexibility in a distal portion of the shaft. An inflation balloon is attached to the distal end of the shaft. The shaft includes an inflation lumen formed through the inner coil and a wire guide lumen formed through the distal portion of the shaft and extending through the chamber of the balloon.

Abstract: An introducer set includes an introducer and dilator along with an extension in a sealed sterile peal open package. The extension is available for use during procedures where the puncture access site to the patient is close enough to the site to be treated in the patient that the physician's hands and/or head may be positioned in the fluroscopic area while the physician is attempting to maneuver a wire guide to a desired location. When the extension is attached to the introducer, the physician may perform a procedure, such as an antigrade stick in the lower leg of a patient, while maintaining their hands and head outside of the fluroscopic area while direct radiation is being supplied and the wire guide is being maneuvered to a desired treatment location.

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. The shaft includes two lumens, one of which houses a stent deployment shaft configured to deploy a self-expanding stent disposed in a distal extension of the shaft.

Abstract: A reinforced catheter or sheath includes an inner tube manufactured via an extrusion process from a mixture of thermoplastic and hollow glass beads. The resultant tube exhibits an inner goose bump surface that defines a central lumen. A reinforcement, such as a braid and/or coil is attached to at least a segment of the outer surface of the inner tube. A second tube of thermoplastic is extruded over at least a portion of the reinforcement. The inner goose bump surface exhibits a net low coefficient of friction comparable to that of polytetrafluoroethylene (PTFE).

Abstract: A balloon catheter device includes a multifilar tube shaft having a shaft lumen. A shaft lumen coating is provided on a surface of the multifilar tube shaft and extends from a proximal end of the multifilar tube shaft and terminates before a distal end of the multifilar tube shaft. An inflation balloon is disposed at the distal end of the multifilar tube shaft such that the shaft lumen coating and the inflation balloon form a continuously sealed length of the shaft lumen. The shaft lumen defines an inflation lumen that is in fluid communication with an interior space of the inflation balloon.

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: 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. The device includes a wholly external wire guide structure secured to the tubular shaft by a figure-eight polymer sleeve.

Abstract: Catheter balloon assemblies (10) for delivering a therapeutic agent to a body vessel are provided, as well as related methods of manufacturing and methods of treatment. The catheter balloon assemblies may include a concentrically disposed dual balloon assembly at the distal portion of the catheter having an inner balloon (44), a porous outer balloon (42) concentrically arrayed around the inner balloon and a catheter shaft (30) adapted to deliver a therapeutic agent to the body vessel through the apertures in the outer balloon. Radial outward expansion of the inner balloon may urge the outer balloon into contact with the wall of a body vessel, where the therapeutic agent may be delivered from the catheter shaft through apertures in the outer balloon directly to the wall of the body vessel.

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: A method for embolic protection during treatment of a stenotic lesion in a body vessel is provided. The method comprises disposing an embolic protection device in an undeployed state in the body vessel. The device comprises a basket with a set of struts extending from a distal end to a proximal end of the basket, the struts being arranged to define an opening at the distal end, the basket having an expanded state and a collapsed state. A core wire with a distal end and a proximal end is able to reciprocate through the opening at the distal end of the basket. A filter bag is attached only at the distal end of the core wire, the filter bag being located distally to the distal end of the basket when in the collapsed state. The method further comprises moving the core wire relative to the basket to expand the basket and the filter bag in a deployed state downstream from the stenotic lesion to capture emboli during treatment of the stenotic lesion.

Abstract: A method of forming an introducer sheath having a crease-free tapered distal tip portion. A mandrel is provided having an outer configuration comprising an elongated body and a tapered distal tip portion. A generally tubular inner liner comprising heat shrinkable PTFE, is positioned over the mandrel. The inner liner is heat shrunk to the outer configuration of the mandrel, in a manner that avoids the formation of creases along the inner diameter of the liner. A reinforcing member is positioned over a length of the inner liner, and an outer jacket is positioned over the reinforcing member and the inner liner. The liner, reinforcing member, and outer jacket are heated in a heat shrink enclosure, whereby the outer jacket melts and bonds to an outer surface of the inner liner.

Abstract: A method for embolic protection during treatment of a stenotic lesion in a body vessel is provided. The method comprises disposing an embolic protection device in an undeployed state in the body vessel. The device comprises a basket with a set of struts extending from a distal end to a proximal end of the basket, the struts being arranged to define an opening at the distal end, the basket having an expanded state and a collapsed state. A core wire with a distal end and a proximal end is able to reciprocate through the opening at the distal end of the basket. A filter bag is attached only at the distal end of the core wire, the filter bag being located distally to the distal end of the basket when in the collapsed state. The method further comprises moving the core wire relative to the basket to expand the basket and the filter bag in a deployed state downstream from the stenotic lesion to capture emboli during treatment of the stenotic lesion.

Abstract: A balloon catheter device (300) of the present invention includes an elongate catheter shaft (301) comprising a helically-cut hypotube having a proximal portion and a distal portion. The proximal portion includes a coating that allows the shaft to provide a patent fluid passage, and a part of the distal portion inside a balloon (304) may be uncoated or otherwise open to the balloon lumen, allowing for passage of fluid through the shaft into the balloon lumen.

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: 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 introducer sheath and a method for making the sheath. The sheath includes a fluoropolymer liner having a passageway extending longitudinally therethrough. An inner jacket is positioned longitudinally over the liner, and the inner surface of the inner jacket is bonded to the outer surface of the liner. An outer jacket is positioned longitudinally over the inner jacket, and the inner surface of the outer jacket is bonded to the outer surface of the inner jacket. A reinforcing coil is encapsulated within the inner jacket and the outer jacket.

Abstract: A method of forming an introducer sheath having a crease-free tapered distal tip portion. A mandrel is provided having an outer configuration comprising an elongated body and a tapered distal tip portion. A generally tubular inner liner comprising heat shrinkable PTFE, is positioned over the mandrel. The inner liner is heat shrunk to the outer configuration of the mandrel, in a manner that avoids the formation of creases along the inner diameter of the liner. A reinforcing member is positioned over a length of the inner liner, and an outer jacket is positioned over the reinforcing member and the inner liner. The liner, reinforcing member, and outer jacket are heated in a heat shrink enclosure, whereby the outer jacket melts and bonds to an outer surface of the inner liner.