Abstract: Loading systems for compressing and loading an implantable medical device into a device chamber of a medical device delivery system are described. The loading systems include an elongate holding chamber within which the intraluminal medical device is disposed. A plunger has one or more attached pushers adapted to axially advance the intraluminal medical device through an intermediate portion of the holding chamber that has a tapered surface, which compresses the intraluminal medical device over a dilator of a medical device delivery system that has been introduced through the distal end of the elongate holding chamber. The elongate holding chamber can be placed within an outer storage container with an appropriate seal to for storage of the intraluminal medical device within the loading system. Methods of preparing an intraluminal medical device for implantation in a patient and kits useful in such methods are also described.

Abstract: In at least one embodiment of the present invention, a method for stabilizing a collapsed vertebra of a patient is provided. The method comprises introducing a supercooled liquid into the collapsed vertebra. A solid structure that supports the collapsed vertebra is then form by solidifying the supercooled liquid.

Abstract: An apparatus for compressing a stent includes a flexible sheet having a first portion curved over toward a second portion of the sheet, such that the sheet includes a generally cylindrical opening. A compression wedge and a curved surface of a platen sandwich at least the second portion of the sheet, and the compression wedge is adjacent to the generally cylindrical opening. A size of the generally cylindrical opening is changed by relative curvilinear motion of the compression wedge and the platen.

Abstract: There is disclosed a device for removing chronic total occlusions (CTO) from blood vessels or other body lumens. In one embodiment the device has a loop at a distal end connected by a shaft to a proximal end. The shaft is provided inside a catheter that has an opening at the distal end and a handle at the proximal end. By manipulating the position of the loop relative to the opening, the effective stiffness of the loop may be changed. This allows a physician to vary the loop stiffness so as to be appropriate with regard to the toughness of a CTO (some CTOs have a relatively tough exterior but a relatively soft interior). The loop may have a single turn or may comprise two or more turns.

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: A stent assembly includes a stent, a graft material and a retainer. The graft material is secured between the stent and the retainer by retaining members on the retainer and complimentary receiver regions on the stent. In order to secure the graft material, the retainer is oriented relative to the stent so that the retaining members align with the receiver regions. The orientation of the retainer relative to the stent allows the retaining members to cooperate with the receiver regions. As a result, the graft material is secured against the stent without perforating the graft material.

Abstract: A multi-lumen catheter assembly for use in the extracorporeal treatment of a body fluid of a patient. The catheter assembly includes an elongated catheter body having a pair of lumens extending therethrough, and a septum separating the lumens. The catheter body has an aspiration port in communication with a first lumen for transporting fluid withdrawn from a body vessel to a treatment unit, and an infusion port in communication with a second lumen for return of treated fluid to the vessel. The infusion port is positioned distal of the aspiration port along a length of the catheter body. A flexible member is provided, wherein the flexible member has an end receivable in the first lumen and another end engaged with the catheter body distal of the aspiration port. The flexible member is structured and arranged to maintain a spacing between the aspiration port and a wall of the vessel.

Abstract: A catheter assembly for use in extracorporeal treatment of a body fluid comprises a catheter body having a plurality of lumens extending therein. The catheter body has an aspiration port in communication with a first lumen for transporting fluid withdrawn from a body vessel to a treatment instrument, such as a dialyzer, and an infusion port in communication with a second lumen for return of treated fluid to the vessel. The catheter body includes a wing-like flap portion extending radially from the catheter body and defining the aspiration port. The flap portion is configured and arranged to space the aspiration port from a wall of the body vessel.

Abstract: The invention relates to minimally invasive device for delivering therapeutic or diagnostic agents into a vessel wall. The device includes an introducer tube, a tubular member having a proximal end, a distal end, and a first lumen extending therebetween, the tubular member being slidably disposed within the introducer tube; a plurality of hollow delivery struts, each delivery strut adapted to pierce through inner most layers of the vessel wall and each comprising at least one exit port and at least one stopper to prevent the delivery strut from piercing through the outer most layers of the vessel wall. The delivery struts are disposed on the distal end of the tubular member and are in fluid communication with the first lumen. The invention also relates to methods of delivering the device of this invention and methods of treating conditions or diseases of body lumens.

Abstract: A balloon catheter having wires situated between an outer layer and a surface of a balloon is described. Each wire may be confined within an interior space of a pocket or encapsulated within a sheath. The pocket includes the outer layer and the balloon surface. The outer layer and balloon surface are unattached to allow the wire to slidably fit between therewithin. The pocket is selectively bonded to the balloon. The sheath includes a preformed shape that completely circumscribes the wire along the longitudinal and radial directions of the wire. The confined and encapsulated feature of the wires enable the wires to be atraumatic and remain spaced apart during treatment of calcification of a lesion.

Abstract: A method of making a fiber-reinforced medical balloon is described herein. The method entails pressurizing a portion of a balloon, and ejecting a fiber precursor fluid from at least one nozzle adjacent to the portion. One or more fibers are formed from the fiber precursor fluid and deposited on an exterior surface of the portion. Preferably, the fibers are polymer nanofibers, and the method is carried out using an electrospinning process.

Abstract: A device for providing access to a treatment site within the body of a patient includes a tubular member having a first, generally elongated configuration for introduction into the body of the patient, and deployable therein to a second configuration. The second configuration includes an axially displaced segment along the distal portion of the tubular member. The tubular member includes a side port oriented along the axially displaced segment, and further includes a lumen communicating with the side port. The lumen and side port are sized for passage therethrough of an interventional device for delivery to the treatment site.

Abstract: The present invention provides apparatus and methods for treating vascular conditions, and in particular, hardened or fibrous material in a stenosis. In a first embodiment, the apparatus comprises a catheter having proximal and distal regions and a plurality of balloons segments disposed on the distal region at intervals about a circumference of the catheter. A first set of opposing balloon segments are configured to be inflated at substantially the same time to apply a first pressure on the vascular condition, and then a second set of opposing balloon segments are configured to be inflated at substantially the same time to apply a second pressure on the vascular condition. The plurality of balloon segments may be formed by taking one length of balloon material and affixing the material to an outer surface of the catheter at a plurality of segment dividing locations to separate adjacent balloon segments, or alternatively, by providing multiple separate balloon materials.

Abstract: A medical device for providing wall apposition of two bodily walls in accordance with the teachings of the present invention. The medical device is used at a previously formed puncture site having perforations formed in the walls. By way of example, the two walls are described herein as the abdominal and gastric walls, although it will be recognized that any two bodily walls may be fastened together utilizing the medical device and the methods described herein. It will also be understood that the procedures described herein may be performed using image guidance such as fluoroscopy, although the device and method may readily be performed without such assistance.

Abstract: A bolster assembly for use in aligning a tubular interventional device along an outer epidermal layer of a patient. A base portion of the assembly has a first surface for contacting the epidermal layer at an exit site of the tubular interventional device from the body of the patient, and has a second surface generally opposite the first surface. An elongated member is engaged with the base portion second surface and extends therefrom at a first angle. The elongated member and the base portion are structured and aligned to define a passageway to enable passage therethrough of the tubular interventional device. The elongated member is capable of flexure relative to the base portion from the first angle to a second angle generally parallel to the epidermal layer. A retaining member is provided for releasably retaining the elongated member at the second angle.

Abstract: The present invention provides apparatus and methods for treating a vascular condition by restoring patency to a vessel while reducing the likelihood that emboli become dislodged into the bloodstream. In a first embodiment, the apparatus comprises a graft having proximal and distal regions, a first support member attached to the distal region of the graft, and a second support member attached to the proximal region of the graft. The first and second support members may comprise first and second stents, respectively. The first stent is deployed distal to a vascular condition, and the second stent is deployed proximal to a vascular condition, such that the graft spans the length of the vascular condition to entrap emboli during treatment of the vascular condition.

Abstract: The present invention provides a gastrostomy or jejunal device for extended insertion into an abdomen of a patient. The device includes a catheter and a coaxial sheath that surrounds the catheter. The sheath includes a plurality of curved or oblique slots through the sheath materials that form a plurality of arms. A rotatable actuation device is provided to twist the sheath along its longitudinal axis which places the arms in compression and causes them to buckle radially outward beyond the circumference of the remainder of the sheath when the actuation device is rotated with respect to the remainder of the device.

Abstract: An elongate medical device configured for navigation through a lumen is provided. The device includes an elongate shaft having a proximal portion and a distal portion. The distal portion includes a first interlocking connector. The device further includes a loop portion operably connected to the distal portion. The loop portion includes a second interlocking connector configured for connecting to the first interlocking connector. A medical system is also provided including a catheter and a wire guide. A method of making a wire guide is provided.

Abstract: Various systems for compressing and loading an expandable medical device into a sheath are disclosed. One system comprises an array of moveable blades radially disposed about a central axis and forming a radially contractible aperture. The blade array includes at least a first plurality of blades and a second plurality of blades. The first plurality of blades is independently moveable with respect to the second plurality of blades. Additional aspects of the invention include methods of using the various compressor systems to compress and load an expandable medical device into a sheath.

Abstract: A balloon catheter assembly comprises an elongate catheter shaft having a proximal portion and a distal portion, and an inflatable balloon secured to the shaft distal portion. A plurality of cutters are arranged along an outer surface of the balloon. The cutters are shielded by folds of the balloon when the balloon is uninflated, and are arranged and configured to facilitate breakdown of a vascular restriction when said balloon is inflated. Preferably, the cutters are arranged in at least three generally parallel longitudinal rows along the balloon outer surface, and there are at least three longitudinally-aligned cutters in each row. Preferably, the cutters are formed of the same or a similar base composition as the balloon, and are bonded to the balloon outer surface.