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: 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 supportive balloon catheter which may be used to assist a wire guide in advancing across a lesion which partially or totally occludes an intraluminal passage. The supportive balloon catheter is advanced over the wire guide, close to the location of the lesion. The supportive balloon catheter is then inflated, securing the position of the wire guide in the intraluminal passage. A braid on the catheter may provide additional structural support. The secured catheter restricts the movement of the wire guide advancing across the lesion, preventing kinking or deflection off the surface of the lesion. Once the wire guide has advanced across the lesion, the supportive balloon catheter or a different angioplasty may be used to clear the lesion from the intraluminal passage.

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 method of treating lower leg ischemia in a patient includes advancing a wire guide upstream through a vascular access sheath extending into an artery of the patient at a percutaneous entry point in the lower leg, and increasing a downstream flow of blood through the artery at least in part by dilating a constriction in the artery with a treatment mechanism guided into the constriction via the wire guide. 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: 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: 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 method of treating lower leg ischemia in a patient includes advancing a wire guide upstream through a vascular access sheath extending into an artery of the patient at a percutaneous entry point in the lower leg, and increasing a downstream flow of blood through the artery 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: A lumen re-entry system includes a catheter having an elongate tubular body defining a wire lumen extending from an open proximal end of the elongate tubular body to a distal opening through the elongate tubular body. An abrasion resistant tubular liner is positioned within the wire lumen and has a fixed position relative to the elongate tubular body. The abrasion resistant tubular liner defines a reduced wire lumen extending from an open proximal end of the abrasion resistant tubular liner to an open distal end of the abrasion resistant tubular liner. A puncture wire is configured for axial movement through the reduced wire lumen and has an angled distal segment terminating in a puncture tip. The angled distal segment is oriented at an angle between about 10 degrees to about 90 degrees relative to a central longitudinal axis of the puncture wire.

Abstract: A supportive balloon catheter which may be used to assist a wire guide in advancing across a lesion which partially or totally occludes an intraluminal passage. The supportive balloon catheter is advanced over the wire guide, close to the location of the lesion. The supportive balloon catheter is then inflated, securing the position of the wire guide in the intraluminal passage. A braid on the catheter may provide additional structural support. The secured catheter restricts the movement of the wire guide advancing across the lesion, preventing kinking or deflection off the surface of the lesion. Once the wire guide has advanced across the lesion, the supportive balloon catheter or a different angioplasty may be used to clear the lesion from the intraluminal passage.

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 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 system for bypassing a vascular occlusion includes a catheter, and a puncturing mechanism within the catheter having a sleeve and a puncture wire positioned within the sleeve. The puncture wire is elastically deformable between an access configuration, and a deployed configuration. The puncture wire has a shape memory bias and is retracted within the sleeve and held by the sleeve in opposition to the bias in the access configuration.

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: A lumen re-entry system includes a catheter having an elongate tubular body defining a wire lumen extending from an open proximal end of the elongate tubular body to a distal opening through the elongate tubular body. An abrasion resistant tubular liner is positioned within the wire lumen and has a fixed position relative to the elongate tubular body. The abrasion resistant tubular liner defines a reduced wire lumen extending from an open proximal end of the abrasion resistant tubular liner to an open distal end of the abrasion resistant tubular liner. A puncture wire is configured for axial movement through the reduced wire lumen and has an angled distal segment terminating in a puncture tip. The angled distal segment is oriented at an angle between about 10 degrees to about 90 degrees relative to a central longitudinal axis of the puncture wire.

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 balloon catheter device of the present invention includes an elongate catheter shaft comprising multifilar cable tubing 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 may be uncoated or otherwise open to the balloon lumen, allowing for passage of fluid through the shaft into the balloon lumen.

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: 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.