Abstract: A hybrid stent is formed which exhibits both high flexibility and high radial strength. The expandable hybrid stent for implantation in a body lumen, such as a coronary artery, consists of radially expandable cylindrical rings generally aligned on a common longitudinal axis and interconnected by one or more links. In one embodiment, a dip-coated covered stent is formed by encapsulating cylindrical rings within a polymer material. In other embodiments, at least some of the rings and links are formed of a polymer material which provides longitudinal and flexural flexibility to the stent. These polymer rings and links are alternated with metallic rings and links in various configurations to attain sufficient column strength along with the requisite flexibility in holding open the target site within the body lumen. Alternatively, a laminated, linkless hybrid stent is formed by encapsulating cylindrical rings within a polymer tube.

Abstract: An intravascular guide wire having at least two core materials joined together. There is a wire 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 formed into complementary shapes, and then placed into a flexible sleeve in opposing directions. Inside the flexible sleeve, the complementary shaped ends are joined together through bonding, welding, brazing, cementing, or soldering. The flexible sleeve can be either a stretched coil or a polyimide sleeve, each with an outer diameter similar to the outer diameter of the core wire, therefore the guide wire does not require additional grinding to reduce the outer diameter of the joined section.

Abstract: A method of making a catheter balloon or other expandable tubular medical device or component thereof formed of a compacted porous polymeric material, in which a tube of porous polymeric material is axially compacted, preferably without increasing the outer diameter of the tube, by positioning heat shrink material on the porous polymeric tube and heating the heat shrink material to decrease the length and diameter of the heat shrink material.

Abstract: A method of making a catheter balloon, and a balloon formed thereby, in which a polymeric tube is radially expanded in a mold having a wall with an outer surface and an inner surface defining a chamber, and having at least a section with one or more channels in the wall. The channels result in improved transfer of heat to the polymeric tube within the chamber of the mold during blow molding of the tube to form a balloon, so that the tube is heated more quickly and evenly. One aspect of the invention is directed to a balloon having sections with improved thin walls.

Abstract: A catheter having an multilayered shaft section with a first layer formed of a polyimide first material and a second layer formed of a second material. In a presently preferred embodiment, the polyimide material is a thermoset polyimide. However, in alternative embodiments, a thermoplastic polyimide is used. The thermoset polyimide has a very high glass transition temperature (Tg) of approximately 400° C. (as measured by differential scanning calorimetry), and excellent dimensional stability at the processing temperature of polyamides commonly used in catheter components. As a result, during formation and assembly of the catheter, production of a thin polyimide layer with controlled dimensions is facilitated. The polyimide has a high modulus and provides a thin walled yet highly pushable shaft section, while the second layer provides kink resistance. In one embodiment, the second material is selected from the group consisting of a polyamide material and a polyurethane material.

Abstract: The invention is directed to a self-expanding stent for implantation into a body lumen, such as an artery. The stent consists of 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 invention is also directed to a stent delivery system for implantation of a stent in a vessel which includes an outer tubular member having a restraining sheath and an inner tubular member having a distal end which has a compressed stent mounted thereto. The proximal end of the inner tubular member is connected to a housing assembly which prevents the inner tubular member from moving when the outer tubular member is retracted to deploy the stent.

Abstract: Methods of coating an implantable device and a system for performing such methods are disclosed. An embodiment of the method includes applying a coating substance to the surface of an implantable device, and rotating the implantable device in a centrifuge. The method can uniformly coat the implantable device with the coating substance and to remove unwanted accumulations of coating substance entrained between struts or crevices in the implantable device body. This system is applicable to methods for coating intraluminal stents, synthetic grafts, and stent coverings with therapeutic compositions comprising therapeutic agents mixed with a polymeric matrix and a solvent.

Abstract: A catheter device having an elongated tubular member with a proximal end and a distal end, and a needle disposed near the distal end. In one embodiment, the needle has a rigid, penetrating tip coupled to a flexible portion by an overlapping joint. The flexible portion enables the needle to bend to a penetrating angle relative to the distal end of the elongated tubular member and penetrate a body tissue without kinking.

Abstract: A radiopaque nitinol medical device such as a stent for use with or implantation in a body lumen is disclosed. The stent is made from a superelastic alloy such as nickel-titanium or nitinol, and includes a ternary element selected from the group of chemical elements consisting of iridium, platinum, gold, rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium, or hafnium. The added ternary element improves the radiopacity of the nitinol stent comparable to that of a stainless steel stent of the same size and strut pattern coated with a thin layer of gold. The nitinol stent has improved radiopacity yet retains its superelastic and shape memory behavior and further maintains a thin strut/wall thickness for high flexibility.

Abstract: An expandable stent for implantation in a body lumen, such as an artery, is disclosed. The stent consists of a plurality of radially expandable cylindrical elements generally aligned on a common longitudinal stent axis and interconnected by one or more interconnecting members placed so that the stent is flexible in the longitudinal direction. The strength of the stent at a center section or at either end can be varied by increasing the mass of the struts forming each cylindrical element in that center section or end section relative to the lower mass struts in the remaining sections of the stent. Increasing the mass of the struts can be accomplished by, for a given strut thickness, increasing the width of the strut, or increasing the length of a cylindrical element.

Abstract: An intravascular stent assembly for implantation in a body vessel, such as a coronary artery, includes undulating circumferential rings having peaks on the proximal end and valleys on the distal end. Adjacent rings are coupled together by links. The rings and links are arranged so that the stent has good conformability as it traverses through, or is deployed in, a tortuous body lumen. The stent is also configured such that the likelihood of peaks and valleys on adjacent rings which point directly at each other to overlap in tortuous body vessels is reduced.

Abstract: An improved intracorporeal device such as a guide wire or other guiding member for use within a patient's body that is at least in part visible under magnetic resonance imaging (MRI) but is not detrimentally affected by the imaging is disclosed. The intercorporeal device has a non-conductive proximal core section, an essentially non-magnetic metallic distal core section that is preferably more flexible than the proximal core section, and that has an MRI visible member or coil in the distal section.

Abstract: An assembly is provided which can crimp or compress an intraluminal device or measure the radial strength of an intraluminal device. The device includes a first disk and a second disk for imparting movement to a number of spaced apart moving elements attached to linear sliders on the first disk. In one configuration, rotational movement is imparted to the second disk which causes the tips of the moving elements to move is a linear direction toward the center of the opening formed by the elements thereby closing in on the device. In another configuration, rotational movement is imparted to the first disk and the tips move along an arcuate path from the perimeter of the opening toward the center of the opening.

Abstract: A balloon catheter and a method of making the balloon catheter, having a balloon which is bonded to an elongated shaft, and which has a first layer and a second layer and an improved bond between the balloon and the shaft. One aspect of the invention is directed to a balloon in which the balloon first layer includes eUHMWPE and has at least a section that has been oxidized with a chromic acid solution to provide improved bondability.

Abstract: An intraluminal catheter comprising an elongated catheter shaft having proximal and distal ends and at least one lumen, and a tip member on a distal end of the catheter having a proximal end spaced distally apart from the distal end of the catheter shaft.

Abstract: An intraluminal catheter, such as a guiding catheter, employed for intravascular procedures and having an inner liner formed of expanded Ultra High Molecular Weight Polyethylene (UHMWPE) is disclosed. The expanded UHMWPE is microporous and has an oriented microstructure structure characterized by nodes interconnected by fibrils. The inner liner formed of expanded UHMWPE is very thin to maximize the inner lumen diameter and has excellent mechanical properties.

Abstract: A catheter having an elongated shaft having at least a section which is multilayered with a first layer and a second layer secured to the first layer, and a mandrel having at least a section between the first and second layers. In one presently preferred embodiment, the mandrel is in contact with an outer surface of the first layer and with an inner surface of the second layer.

Abstract: A system for delivery of an intraluminal treatment device is provided. A guide wire having a recessed portion is combined with an intraluminal treatment device having a mechanism for securing the intraluminal treatment device to the recessed portion. This system permits an intraluminal treatment device to be secured to the guide way prior to or after the intraluminal delivery of the guide wire.

Abstract: The invention is directed to adjustable length mold assemblies for forming inflatable members and methods for using adjustable length mold assemblies for forming inflatable members, such as, for example, balloons for use with balloon catheters and stent delivery systems. The adjustable length mold assemblies comprise at least two mold pieces adapted to fit together, one mold piece having a surface configured to be slidably received by a bore of the other mold piece, the placement of one piece within the other defining a chamber of variable length which forms the mold. Each adjustable length mold assembly of the present invention is effective to form balloons, where if desired different balloons formed by a single mold may have different lengths. The adjustable length mold assemblies may also comprise a positioner to put a mold piece in a desired position relative to the other, and a locking mechanism to secure a mold piece in a desired position.

Abstract: A deformable sheath is attached to a catheter and introduced intravascularly to be expanded against an arterial wall and entrap plaque therebetween. A stent is subsequently deployed within the expanded sheath and the sheath is then withdrawn from within the vasculature to leave the stent expanded against the arterial wall with the plaque entrapped therebetween.