Abstract: Methods for forming low profile balloons for use with a catheter by providing a polymeric tube, removing material from the outer surface of the polymeric tube around at least one of its end portions, and inflating a region of the polymeric tube between the two end portions to form the balloon. Low profile balloons having end portions with an outer diameter below 30 mils are also disclosed.

Abstract: A therapeutic intravascular device and method for performing thermal and laser Doppler velocimetry measurements. In one embodiment, the therapeutic intravascular device includes an elongated member having first and second optical fibers longitudinally disposed therethrough, the first optical fiber for performing a laser Doppler velocity measurement of a fluid within a body lumen, the second optical fiber for performing a temperature measurement within the body lumen.

Abstract: A drug eluting medical device is disclosed. The device includes a barrier layer for reducing the rate of release of a drug.

Abstract: A coating for a stent and methods for coating a stent are provided. The coating may be used for the sustained delivery of an active ingredient or a combination of active ingredients.

Abstract: A method of forming a catheter component, such as a balloon, in which the component has a thinned skirt section formed by expanding tubing to a radially enlarged outer diameter and then decreasing the inner diameter and the outer diameter of the radially enlarged skirt section before or during bonding of the skirt section to the catheter shaft. The method generally includes blow molding tubing in a balloon mold having a skirt portion with an inner diameter which is larger than an outer diameter of the thinned skirt section of the balloon, so that the balloon mold produces a balloon having a radially enlarged skirt section with a larger outer diameter than is desired for the finished balloon. By then decreasing the diameter of the radially enlarged skirt section, the resulting skirt section is thinned, to provide a balloon catheter having improved flexibility and low profile.

Abstract: A coating for a prosthesis, for example a stent, and a composition for forming the coating is disclosed. The coating can serve as a primer, allowing substances, such as polymers, to be effectively secured by the prosthesis. Alternatively, the coating can serve as a reservoir, allowing for the local and sustained release of a therapeutic substance to biological tissues. The composition can be formed from an ethylene vinyl alcohol copolymer and a dimethylsulfoxide solvent, with or without a therapeutic substance. Alternatively, the composition can be formed from an ethylene vinyl alcohol copolymer, a dimethylsulfoxide solvent, and a wetting fluid, with or without a therapeutic substance. The composition is applied to a surface of the prosthesis and essentially all of the dimethylsulfoxide solvent or dimethylsulfoxide solvent/wetting fluid is removed or allowed to evaporate to form the coating.

Abstract: An expandable metallic stent has discontinuities of non-conducting material. These eliminate electrically conducting paths in the stent rings and cells. This makes the stent easier to image with magnetic resonance imaging (MRI). The non-conducting material can include adhesives, polymers, ceramics, composites, nitrides, oxides, silicides, and carbides. The discontinuity is preferably shaped so that during expansion the discontinuity is placed in primarily a compressive stress.

Abstract: The invention is directed to a guidewire having a distal section with multiple distally tapered core segments with at least two contiguous distally tapering core segments in which the most distal tapered core segment preferably has a greater degree of taper than the proximally contiguous tapered core segment. The invention is also directed to an elongated intracorporeal device, preferably a guidewire or section thereof, that has a core member or the like with a plurality of contiguous tapered segments having taper angles that are configured to produce a linear change in stiffness over a longitudinal section of the device. The device may also have a core section with a continuously changing taper angle to produce a curvilinear profile that preferably is configured to produce a linear change in stiffness of the core over a longitudinal section of the device.

Abstract: The present invention provides for an improved stent design and stent delivery catheter assembly for repairing a main vessel and a side branch vessel forming a bifurcation. The present invention includes a trap door stent design, a stent delivery catheter assembly, an apparatus for crimping the stent and the method for crimping the stent onto the catheter assembly, and the method for delivering and implanting the stent in a bifurcated vessel. More particularly, the invention relates to a stent having rings aligned along a common longitudinal axis and connected by links, where the stent has a proximal section, a distal section and a central section. The number of rings and the expanded diameter of the sections is varied to create a “trap door” capable of expanding to a slightly larger diameter than the proximal section and distal section of the stent.

Abstract: A self-expanding stent for implantation into a body lumen, such as an artery, includes a plurality of radially expandable cylindrical elements generally aligned on a common longitudinal stent axis and interconnected by a plurality of interconnecting members placed on the stent in a collinear arrangement such as to create at least one continuous spine which extends along the length of the stent. The stent has cylindrical elements at each end of the stent which includes a plurality of double curved portions.

Abstract: A rotary coating apparatus and a method of coating medical devices, such as stents, is disclosed.

Abstract: An increase in agent residence time at a tissue site is provided for by the presence of a barrier. The barrier is a separate entity from the agent when introduced to the tissue. A binding member is included in the barrier for coupling the barrier to the surface of the tissue. In one embodiment, agent is introduced to the tissue prior to attachment of the barrier to the tissue. In another embodiment, agent is presented after the barrier is positioned on the tissue surface. A delivery vehicle may be used to administer the agent and barrier to a patient.

Abstract: A catheter for insertion in a physiological lumen is provided which includes two balloons, wherein the distance between the balloons can be adjusted. The catheter can be used for the delivery of a therapeutic substance for the treatment of conditions such as restenosis.

Abstract: An embolic protection device that employs a superelastic alloy self-expanding strut assembly with a small profile delivery system for use with interventional procedures is disclosed. The expandable strut assembly is covered with a filter element and both are compressed into a restraining sheath for delivery to a deployment site downstream and distal to the interventional procedure. Once at the desired site, the restraining sheath is retracted to deploy the embolic protection device, which captures flowing emboli generated during the interventional procedure. The expandable strut assembly is made from a superelastic alloy such as nickel-titanium or nitinol, and includes a ternary element in order to minimize the stress hysteresis of the superelastic material. The stress hysteresis is defined by the difference between the loading plateau stress and the unloading plateau stress of the superelastic material. The resulting delivery system including the restraining sheath has a small profile and has a thin wall.

Abstract: An embolic protection device for use in a blood vessel when an interventional procedure is being performed in a stenosed or occluded region to capture any embolic material which may be created and released into the bloodstream during the procedure. The device includes a filtering assembly having a self-expanding strut assembly and a filter element attached thereto. In one embodiment, the filtering assembly is attached to the distal end of a guide wire and is deployed within the patient's vasculature as the guide wire is manipulated into the area of treatment. A restraining sheath placed over the filtering assembly in a coaxial arrangement maintains the filtering assembly in its collapsed position until it is ready to be deployed by the physician. Thereafter, the sheath can be retracted to expose the filtering assembly which will then self-expand within the patient's vasculature.

Abstract: Porous vascular grafts and stent covers are formed of open-celled microcellular polymeric foams having a porosity that can be modified to be adapted for carrying and delivering different types of therapeutic drugs. A stent cover is formed of a tubular member including at least one layer of a porous, microcellular foam formed from a polymeric material capable of absorbing and releasing therapeutic drugs at predictable rates for delivery of the therapeutic drugs in localized drug therapy in a blood vessel. A composite metal and polymer vascular graft is formed of an interior structural stent member, and an outer layer or coating of the porous, microcellular foam.

Abstract: A method including positioning a catheter at a location in a blood vessel; imaging a thickness of a portion of a wall of the blood vessel at the location; identifying a treatment site; advancing a needle a distance into the wall of the blood vessel to the treatment site; and introducing a treatment agent through the needle to the treatment site. A composition including an inflammation-inducing agent and a carrier in the form of microspheres having a particle size suitable for transvascular delivery. A composition including a therapeutic angiogenesis promoter in a carrier and an opsonin-inhibitor coupled to the carrier. An apparatus for delivery of a therapeutic angiogenesis promoter.

Abstract: An intravascular guide wire having at least two core materials joined together without the use of a hypotube. There is a core having a proximal core section with a proximal end and a distal end and a distal core section with a proximal end and a distal end. The distal end of the proximal core section and the proximal end of the distal core section are ground into complementary shapes, and then placed into a fixture in opposing directions with a small gap in-between the ends to receive a mass of hardened material to wick therein. Once the proximal and distal core sections are bonded, welded, brazed, cemented, or soldered together, the guide wire is then ground to a required outer diameter, depending on the design needs of the specific guide wire.

Abstract: A balloon catheter system generally having an elongated catheter shaft with enhanced flexibility to facilitate more distal advancement within a patient's body lumen. The catheter shaft has a relatively stiff proximal shaft section, a relatively flexible distal shaft section and an intermediate shaft section which provides a smooth, flexible transition between the proximal and distal shaft sections. The intermediate shaft section has an improved construction with a tubular reinforcing member secured by its proximal end to the distal extremity of the proximal shaft section and a distal end secured within the proximal end of the distal shaft section. The tubular reinforcing member preferably has an inner tubular support member which has a proximal end secured to the distal end of the proximal shaft section. Preferably, the proximal shaft section has an outer jacket which extends over the tubular reinforcing member of the intermediate shaft section.

Abstract: A dilatation catheter assembly which has a dilatation catheter with a sheath mounted on the catheter shaft having an inner lumen extending in the distal portion of the sheath which is configured to slidably receive at least a portion of the dilatation balloon on the distal end of the catheter. The position of the sheath is fixed with respect to the catheter, e.g. a friction fit or bonded in some manner, before the assembly is inserted into the patient's vasculature with the distal portion of the sheath covering a portion of the balloon but leaving a portion of the balloon uncovered with a length equal to the stenotic region to be dilated so that the entire stenosis can be dilated at the same time. The distal portion of the sheath is preferably formed of a flexible polymeric tube with inelastic reinforcement to prevent substantial expansion thereof when the balloon is inflated.