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 nitinol stent has improved radiopacity yet retains its superelastic and shape memory behavior and further maintains a thin strut/wall thickness for high flexibility. Another embodiment includes a balloon expandable stent made from a radiopaque and MRI compatible alloy such as 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, hafnium, osmium, zirconium, niobium, or molybdenum.

Abstract: Stent designs for use in peripheral vessels, such as the carotid arteries, are disclosed. The stents consist 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 a longitudinal direction. The cylindrical elements are generally serpentine wave pattern transverse to the longitudinal axis between alternating valley portion and peak portions, the valley portion including alternating double-curved portions and U-shaped portions. The interconnecting members are attached to the double-curved portions to connect a cylindrical element to an adjacent cylindrical element and interconnecting members are attached to the U-shaped portions to connect the cylindrical element to the other adjacent cylindrical element. The designs include an eight crown and six crown stent which exhibit flexibility and sufficient radial strength to support the vessel.

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: The invention is directed to an expandable stent for implantation in a body lumen, such as a coronary artery or peripheral vein. 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 as to limit longitudinal contraction during radial expansion. The individual radially expandable cylindrical elements are formed in a serpentine pattern having bends alternating in peaks and valleys designed to expand evenly under radial stress, and to maximize the overall radial expansion ratio. Each peak and valley includes reinforcing members that extend across and proximate to each bend. Sizing and construction of the struts forming the peaks and valleys can create bimodal deployment wherein the struts bend under increasing stresses to enable the stent to expand to larger diameters.

Abstract: A medical device for treating a defective heart valve. The medical device comprises a delivery sheath and an implantable device moveably disposed within the delivery sheath. The implantable device further comprises a distal expandable basket, a proximal expandable basket, and a connecting member coupling at a first end to the distal expandable basket and at a second end to the proximal expandable basket. Each of the distal expandable basket and proximal expandable basket is in a collapsed state during delivery and an expanded state after deployment. An actuator is releasably coupled to the implantable device. When coupled to the implantable device, the actuator can move the implantable device in a way to allow for positioning of the distal and proximal expandable baskets.

Abstract: A medical device for use within a body lumen that is made from a binary nickel-titanium alloy that remains in its austenitic phase throughout its operational range is disclosed. The medical device, such as an intraluminal stent, is made from superelastic nickel-titanium and may optionally be alloyed with a ternary element. By adding the ternary element and/or through heat treatment, it is possible to lower the phase transformation temperature between the austenitic phase and the martensitic phase of the nickel-titanium alloy. By lowering the phase transformation temperature, the martensite deformation temperature is likewise depressed. It is possible then to depress the martensite deformation temperature below body temperature such that when the device is used in a body lumen for medical treatment, the nickel-titanium device remains completely in the austenitic phase without appearance of stress-induced martensite even if the device is placed under stress.

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 lead assembly and method of forming a lead assembly is provided. Devices and methods of forming the lead assembly include a support coil. The support coil provides enhanced support and protection from lead damage and failure. A lead assembly and method of forming a lead assembly is also provided including at least one electrode. Electrodes may be incorporated into the support coil design. The lead assembly and method of forming a lead assembly may be incorporated with other medical devices such as an implantable defibrillator.

Abstract: An intravascular stent assembly for implantation in a body lumen, such as a coronary artery, is designed to treat a lesion with vulnerable plaque by reducing the fibrous cap stresses. The stent includes distal, proximal, and center sections where the center section is configured to treat the vulnerable plaque. The stent consists of radially expandable cylindrical rings generally aligned on a common longitudinal stent axis and either directly connected or interconnected by one or more interconnecting links placed so that the stent is flexible in the longitudinal direction while providing high degrees of radial strength and vessel scaffolding.

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: A tubular stent formed from a plurality of cylindrical rings and connecting links where selected connecting links are of comparatively high mass in relation to the other links. The high-mass links have sufficient mass to be visible during a fluoroscopy procedure when formed from a moderately radiopaque material such as stainless steel. The high-mass links being arranged in a spiral pattern along the length of the stent to ensure that the stent is fluoroscopically visible regardless of the stents orientation during the implantation procedure.

Abstract: The present invention is directed to an expandable hybrid stent for implantation in a body lumen, such as a coronary artery. The stent generally consists of metallic cylindrical rings used in connection with polymeric links, polymeric wire or a polymeric coil. The metallic cylindrical rings can include series of radially expandable cylindrical rings longitudinally aligned on a common axis of the stent. The rings can be interconnected by one or more polymeric links or can be disposed over an inner member consisting of a polymeric coil or a series of polymeric wires. Adjacent cylindrical rings can also be connected and arranged in a coil-like spiraling form without interconnecting links. The polymeric material forming the polymeric links, polymeric wire or the polymeric coil can provide longitudinal and flexural flexibility to the stent while maintaining sufficient column strength to space the cylindrical rings along the longitudinal axis.

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: A medical device for use within a body lumen that is made from a binary nickel-titanium alloy that remains in its austenitic phase throughout its operational range is disclosed. The medical device, such as an intraluminal stent, is made from superelastic nickel-titanium and may optionally be alloyed with a ternary element. By adding the ternary element and/or through heat treatment, it is possible to lower the phase transformation temperature between the austenitic phase and the martensitic phase of the nickel-titanium alloy. By lowering the phase transformation temperature, the martensite deformation temperature is likewise depressed. It is possible then to depress the martensite deformation temperature below body temperature such that when the device is used in a body lumen for medical treatment, the nickel-titanium device remains completely in the austenitic phase without appearance of stress-induced martensite even if the device is placed under stress.

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: A compliant membrane is positioned between the interior of an expandable balloon and the inner member of a catheter. The membrane provides a compliant substrate onto which a stent is crimped onto the balloon over the area of the membrane. The compliant membrane effectively retains the stent on the catheter while the stent is being delivered through the vasculature. The retaining force from using a compliant membrane can be obtained by partially filling apertures as described. However, an enhanced retaining force is obtained without this effect. The membrane allows a higher normal force between the stent and balloon because of its compliance. A stent cannot be tightly crimped onto a rigid surface or tube because the elastic recoil of the stent prevents this. The compliant membrane has enough give to compensate for this small but significant elastic recoil. Essentially, the stent is squeezed onto the balloon/membrane slightly more than the final result to obtain a good gripping force.

Abstract: Stent designs for use in peripheral vessels, such as the carotid arteries, are disclosed. The stents consist 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 a longitudinal direction. The cylindrical elements are generally serpentine wave pattern transverse to the longitudinal axis between alternating valley portion and peak portions, the valley portion including alternating double-curved portions and U-shaped portions. The interconnecting members are attached to the double-curved portions to connect a cylindrical element to an adjacent cylindrical element and interconnecting members are attached to the U-shaped portions to connect the cylindrical element to the other adjacent cylindrical element. The designs include an eight crown and six crown stent which exhibit flexibility and sufficient radial strength to support the vessel.

Abstract: An intravascular stent having struts which overlap, at least partially, when the stent is compressed. The overlapping struts allow the stent to be crimped to a smaller initial delivery diameter than may be achieved with non-overlapping designs for given metal density. The stent has a reduced delivery diameter which allows for the construction of reduced profile stent-delivery systems, which thereby allow for the stenting of smaller vessels than has heretofore been possible.

Abstract: A self-expanding, tapered profile stent for implantation in a body lumen, such as an artery, is disclosed. The stent is constructed 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 lengths of the cylindrical elements increase from one end of the stent to the opposite end by increasing the lengths of the struts and the lengths of the interconnecting members. Each cylindrical element is formed from repeating patterns of upright V's and inverted V's connected by straight strut arms with shoulders to create an overall serpentine wave pattern around the circumference. A step, continuous, parabolic, or curved taper in the stent can be imparted by using an expansion mandrel and applying deforming forces to the stent. The stent is made from pseudoelastic and shape memory alloys.

Abstract: An expandable stent having end rings with enhanced strength and radiopacity 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 expandable cylindrical elements have regions which are subject to high stresses and regions subject to low stresses when the cylindrical elements are radially expanded. In order to increase the radiopacity of the stent, the width of the strut in the low stress region of the stent is designed to be wider than the width of the strut in the high stress regions. If a high radiopaque material is utilized and reduced radiopacity is desired, the width of the strut in the low stress region of the stent can be designed to be narrower than the strut width in the high stress regions.