Abstract: Introducer sheath (10,30,40) having a flexible kink-resistant distal tip portion (26,32,42). A multilayer sheath structure is used, with an inner tube (12) such as PTFE having a coil (14) of wire wound therearound. A first length of outer tubing (20) such as of nylon is inserted over most of the coil-wound inner tube (12) in a manner exposing a distal length of coil-wound inner tube. A second length of outer tubing (22) with a softer durometer than first outer tubing length (20), is inserted over the exposed coil-wound inner tube and extends for a slight distance beyond the end of the coil. During heat application, the outer tubing lengths (20,22) are melted to bond to each other and to flow between the spacings of the coil turns to bond to the roughened outer surface of the inner tube (12). The distal tip region corresponding to the second tubing length is flexible and is kink-resistant due to the coil (14).

Abstract: A vascular occlusion device for occluding a body vessel is disclosed. The device comprises a hub having proximal and distal ends and a plurality of anchoring struts. Each anchoring strut has a first end and a second end. The first ends are connected together at the hub. Each of the second ends extends freely from the first end to engage the body vessel for anchoring the device therein. The device further comprises a central strut attached to the proximal end of the hub. The device further comprises a proximal and distal members and an extracellular matrix material. The proximal and distal members are slidibly disposed about the central strut. The extracellular matrix material is disposed about the central strut between the proximal and distal members.

Abstract: An infusion mechanism for treating an intraluminal site in a patient includes an infusion catheter having an elongate body with a proximal body end defining at least one fluid supply orifice, and a distal body end. The elongate body defines a high head loss lumen in fluid communication with a first set of side ports defining a proximal infusion zone. The elongate body further defines a low head loss lumen in fluid communication with a second set of side ports defining a distal infusion zone.

Abstract: A sheath and a method for making said sheath are provided. The sheath includes with an inner liner defining a passageway about a longitudinal axis extending longitudinally therethrough. A coil is fitted around at least a part of the inner liner. The coil has a series of windings that are locatable at a continuously smaller distance from the longitudinal axis to form a taper in a distal direction. The tube further includes an outer layer positioned longitudinally over the coil that is adapted to adhere to the inner liner. The coil may be spirally wound such that the windings are disposed at a continuously smaller distance from the longitudinal axis in a longitudinal direction. The sheath can have a tapered passageway or a passageway with a uniform diameter. The sheath preferably has a continuous taper along its outer surface from the proximal end to the distal end.

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 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 coated implantable medical device includes a structure adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer posited on one surface of the structure; and at least one layer of a bioactive material posited on at least a portion of the coating layer. Preferably the structure is a stent graft.

Abstract: A catheter assembly is provided with a flexible tubular body having two lumens. A solid slidable member with a sharp distal end is disposed within one of the lumens. The slidable member is capable of sliding within the lumen of the tubular body between an exposed position in which the sharp distal end of the slidable member protrudes from the distal end of the tubular body and a shielded position in which the distal end of the slidable member is within the tubular body. One advantage is that the sharp distal end of the slidable member may be withdrawn into the tubular body in order to shield a patient from unintentional cutting or irritation from the sharp distal end of the slidable member.

Abstract: The present invention generally relates to a medical surgical device and specifically a wire guide for percutaneous placement within a body lumen. The wire guide includes an elongated mandrel having sufficient flexibility and kink resistance and a cannula having a stiffness greater than the mandrel stiffness for sufficient pushability. The mandrel extends through the cannula and has a portion extending distal thereto to form a distal tip of the wire guide. The wire guide can further include a slotted cannula to improve the flexibility of the wire guide at the proximal portion of the wire guide. The slots can be arranged in various patterns for increased flexibility along the longitudinal length of the cannula, as well as increased circumferential flexibility along the wire guide. The mandrel may also have a proximally tapered portion to improve the flexibility of the wire guide at the proximal portion of the wire guide.

Abstract: An intraluminal occlusion device includes a frame and an attached covering. The frame includes longitudinal struts having concave and convex portions. The intraluminal occlusion devices can be implanted at an opening to a body vessel, such as a blind passage, to block the entry of fluid into the vessel. Methods of blocking the entry of fluid into bodily passages are also described.

Abstract: A rapid exchange catheter includes a stiff proximal tube and a relatively flexible tapered distal tube, a guide wire tube being provided in the distal tube, with an aperture for access to the guide wire lumen being provided at the junction between the distal tube and the proximal tube, the tubes being bonded together at their junction.

Abstract: A cutting or scoring balloon (10) of elongate shape and provided at its periphery with a plurality of scoring elements (12) extending longitudinally along the balloon. The scoring elements (12) are formed integrally with the balloon wall (14) and in the preferred embodiment are of the same material. A raw material form (20) for producing the balloon (10) is provided with a series of zones (26, 28) of greater thickness compared to the remainder of the balloon wall (24). These zones (26, 28) are located adjacent respective ribs (22) and extend longitudinally along the balloon wall for substantially the same distance as the ribs (22). The zones (26, 28) ensure that these will expand (stretch) preferentially compared to the remainder of the raw material form (20) and in particular the ribs (22), with the effect that the ribs (22) will not tend to be stretched. Apparatus for forming a balloon (10), includes a chamber (50) for holding the raw material form (20, 30) on fittings (52).

Abstract: A method of performing a percutaneous vascular procedure includes sliding a vascular constriction crossing mechanism in a proximal to distal direction over a wire guide having a wire guide tip positioned at a proximal side of a vascular constriction, and rotating a sheath of the vascular constriction crossing mechanism about an axis of rotation relative to another sheath of the vascular constriction crossing mechanism. The method further includes advancing a constriction crossing tip by way of helically engaging the sheaths during the steps of rotating, and guiding an intraluminal treatment device into or past the vascular constriction for performing a vascular procedure within the patient. The vascular constriction crossing mechanism includes a first sheath and a second sheath, and a constriction crossing tip coupled with a distal segment of the first sheath.

Abstract: A method for occluding a body vessel in a patient to block or reduce blood flow therethrough includes puncturing a blood vessel wall at a proximal vessel entry site with a hollow needle and extending the needle through the proximal entry site into the vessel lumen. The needle is extended through the vessel lumen and extended through the vessel wall at a distal vessel exit site into the extravascular space surrounding the distal vessel exit site. An expandable biocompatible material, such as expandable extracellular matrix (ECM) material, is then ejected though the distal end of the needle into the extravascular space. Then, while continuing to eject the expandable biocompatible plug material, the distal end of the needle is retracted back through the distal vessel exit site into the vessel lumen, such that the plug material continuously extends between the extravascular space surrounding the distal vessel exit site into the vessel lumen.

Abstract: A circumferentially and longitudinally continuous scoring structure having a diameter in an initial unrestrained state that is smaller than a deflated diameter of the balloon is disposed around an outer surface of the balloon in an expanded configuration. The scoring structure continually exerts a radially inward compressive force against the balloon such that when the balloon is expanded from a deflated configuration to an inflated configuration, the scoring structure expands in a radially outward direction and remains in continuous compressive contact with at least a portion of the balloon as the balloon unfolds. The scoring structure may be entirely free of attachment to the balloon and catheter, and may extend substantially a length of a working region of the balloon. The scoring structure may include a plurality of circumferentially compressible members connecting longitudinal members.

Abstract: A surgical cutting device comprises a cannula attached to an actuation mechanism that moves the cannula from a cocked position to a cutting position, a stylet including a distal portion having a sharp distal end, a sample collection region, a vacuum port, and a lumen extending from the vacuum port to the sample collection region such that the sample collection region is in fluid communication with the first vacuum port. When the cannula is in the cocked position, the sample collection region of the stylet is disposed distal of the cannula. The device also includes a fixed volume vacuum source. When cannula is in the cocked position, the vacuum port is not in fluid communication with the fixed volume vacuum source, and when said cannula is in the cutting position, the vacuum port is in fluid communication with the fixed volume vacuum source.

Abstract: An intracranial stent formed from Nitinol has variable flexibility. The stent (10) is formed from a plurality of stent rings (12) connected by tie bars (14). The tie bars (14) in a central soft zone (16) are heat treated so as to confer a higher transition temperature on the Nitinol. As a result, at body temperature, the soft zone (16) has reduced longitudinal stiffness as compared to the stiffer zones (18) found at the ends of the stent (10).

Abstract: An expandable roll sock delivery catheter includes an inner tube, an outer tube having a distal outer tube end, and a medical device, such as a self-expanding stent, collapsibly disposed over the inner tube and concentrically oriented between the inner tube and the outer tube. A hollow tube of expandable balloon material extends from the distal outer tube end, the balloon material being substantially disposed in its entirety within a distal end portion of the outer tube. The balloon material is folded back into the outer tube and over the device as a single layer of balloon material connectively linked to the inner tube proximal to the self-expanding device so as to form an expandable roll sock balloon. The roll sock balloon defines an inflation lumen disposed between the outer tube and inner tube, whereby the inflation lumen is configured for expansion of the roll sock balloon following release of the device.

Abstract: This disclosure relates to implantable medical devices coated with a taxane therapeutic agent, such as paclitaxel, in one or more solid form(s) having varying dissolution rates. Particularly preferred coatings comprise amorphous and/or solvated solid forms of taxane therapeutic agents that provide durable coatings that release the taxane over a desired period of time, which can be varied in the absence of a polymer by selecting the type and amount of solid forms of the taxane therapeutic agent in the coating. Other preferred embodiments relate to methods of coating medical devices and methods of treatment. The coatings can provide a sustained release of the taxane therapeutic agent within a body vessel without containing a polymer to achieve the desired rate of paclitaxel elution.

Abstract: A wound closure device for promoting hemostasis includes a polyhedral body comprising a proximal body end portion and a distal body end portion, including a suture channel horizontally extending through the proximal and distal body end portions, the suture channel containing proximal and distal suture channel openings. An actuator system includes a suture engagement member configured to selectively facilitate axial movement or release of one or more sutures through the channel in an open configuration, and to facilitate securement of suture(s) in the channel in a locked configuration. The proximal body end portion includes a face configured to contact a body surface, anchoring the body to the body surface when suture(s) are secured under tension by the engagement member in the locked position. Once the sutures are secured, the device lends itself to hands-free anchoring until hemostasis is achieved. The device and sutures may then be removed that same day, shortly thereafter.