Abstract: The present invention concerns a novel bifurcated stent apparatus for use in treating lesions at or near a bifurcation point in bifurcated vessel. More particularly, a dedicated bifurcation stent apparatus is fabricated from a single tube structure for use in a bifurcated body vessel having a main lumen and a side lumen. The stent apparatus includes a first stent portion comprised of a first stent pattern that is configured for radial expansion into a generally cylindrical main body. A second stent portion is integrally formed with the first stent portion, and includes a second stent pattern configured to form a first branch leg and a second branch leg. Collectively, the first stent portion, and the branch legs form a crocodile cut shape.

Abstract: Disclosed are stent delivery apparatus and methods for moving a balloon catheter carrying a stent through a body vessel without the stent slipping from the balloon are provided. In general, the stent delivery system includes a stent stopper that impedes the stent from slipping from the balloon. The stent stopper is sized to serve as a barrier to the stent as it is carried on the balloon. In a specific embodiment, the stent stopper is formed from a material that encircles the proximal end of the balloon and abuts the proximal end of the stent. The stent stopper material expands with expansion of the balloon and collapses with deflation of the balloon. In some embodiments, the stent stopper material has a thickness that is about equal to or greater than the thickness of the stent so as to form a barrier against the stent and impede the stent from slipping off the proximal end of the balloon.

Abstract: An endoprosthesis for delivery in a body lumen can be configured to inhibit crack formation and/or crack propagation, and/or fatigue-induced catastrophic failure by the use of holes extending through an endoprosthetic element. As such, the endoprosthesis can include at least one strut element having a strut width and a strut thickness, the strut thickness being defined by a first side opposite a second side. The element can be characterized by having a plurality of holes extending from the first side to the second side. The plurality of holes can be arranged in an amount, distribution, and/or pattern so as to inhibit crack propagation across the strut length or strut width.

Abstract: Disclosed is a method for delivery of at least one therapeutic agent from an angioplasty balloon for treating vascular disease at a bifurcated vessel. The invention also relates to the method of loading the beneficial agents onto the balloon and the device, as well as the method of delivery of the agents from separate surfaces.

Abstract: Catheter including an elongate main body having a proximal section and a distal section. The elongate main body further includes a guidewire lumen along at least a portion of the elongate main body. In accordance with a further aspect of the invention, the catheter includes a first stiffening member and a second stiffening in an overlapping spaced relationship along at least a portion of a length between the distal end and the proximal end of the elongate main body.

Abstract: Disclosed is a method for delivery of at least one therapeutic agent from an angioplasty balloon for treating vascular disease at a bifurcated vessel. The invention also relates to the method of loading the beneficial agents onto the balloon and the device, as well as the method of delivery of the agents from separate surfaces.

Abstract: A guidewire apparatus for a medical device that includes an expandable guidewire section that can be locked in an expanded state. In one use, the expandable section can be temporarily locked to a working element of a medical device to facilitate the transmission of torque from the guidewire to the medical device. Hence, this configuration may be utilized to aid in orientation of the working element with a vessel side branch by providing the user with the ability to apply a rotational force to the distal end of the stent delivery system. Another use includes docking the expandable section near an opening into a guidewire lumen at the catheter tip. This configuration is particularly useful in forming a smooth transition between the guidewire and the catheter tip to reduce the phenomenon of fish-mouthing.

Abstract: The invention includes a catheter having an elongate main body having a proximal section and a distal section. The elongate main body further includes a plurality of stiffening members disposed along the length of the elongate main body. The plurality of stiffening members includes a first stiffening member and a second stiffening member. The catheter can also include a balloon formed from a tubular member having a recess defined in a portion of its surface. A tapered or thinned balloon is formed from a process by which material is removed from a tubular member prior to formation of the balloon.

Abstract: A dilatation balloon is fabricated according to a process that forms cavities and indentations in the balloon and/or catheter sections. A length of tubing is axially elongated and radially expanded in a form to provide the requisite biaxial orientation and strength. Then, an excimer laser or another type of laser or mechanical material removal tool is used to remove the polymeric material, virtually without thermal effects. Cavities in the sleeve sections of the balloon are defined and if desired, indentations in the cone sections are defined. Material removal, particularly near the balloon sleeves enables a thinner, more flexible bonding area between the catheter shaft and the balloon. Further, the indentations along the cone sections enables tighter wrapping of the balloon for a reduced delivery profile. Rigidity near the sleeves is reduced for better maneuverability of the catheter in tortuous passageways.

Abstract: The invention includes a catheter having an elongate main body having a proximal section and a distal section. The elongate main body further includes a plurality of stiffening members disposed along the length of the elongate main body. At least one stiffening member includes a plurality of clusters including helical turns or rotations disposed circumferentially about a tubular member and along the length of the cluster. The clusters can be configured to vary flexibility along the length of the tubular member. The catheter can include a sheath having a stationary section and a retractable section.

Abstract: Disclosed is a medical fastener that can be mounted to a bone of a patient. The medical fastener can include a head portion comprising a recess having a first portion, a second tapered portion extending from the first portion, and a third cylindrical portion extending from the second tapered portion. A threaded body portion can extend from the head portion. The first portion and the second portion can have a Torx geometry or star-shaped configuration. Also disclosed is a driver usable to mount the medical fastener to the bone. The driver can include a tip that is complementary to the recess and an end that enables the driver to mount to a drill or other device that can rotate the driver.

Abstract: A stent delivery system is disclosed for delivering and deploying a radially expandable stent at a strategic orientation and location in a body vessel. The delivery system includes an elongated flexible tubular shaft sized suitably for insertion into the body vessel. A stent deployment assembly includes a distal transition portion supporting a dilator device adapted for radial expansion about a longitudinal axis of the deployment assembly from a non-expanded condition to a radially expanded condition. The dilator device is configured to support the stent thereon in the non-expanded condition and in predetermined orientation relative the deployment assembly. A rotational clutch assembly rotatably mounts the transition portion to a distal portion of the tubular shaft such that the deployment assembly is substantially torsionally isolated from the tubular shaft, about a longitudinal axis of the clutch assembly.

Abstract: A stent delivery system is disclosed for delivering and deploying a radially expandable stent at a strategic orientation and location in a body vessel. The delivery system includes an elongated flexible tubular shaft sized suitably for insertion into the body vessel. A stent deployment assembly includes a distal transition portion supporting a dilator device adapted for radial expansion about a longitudinal axis of the deployment assembly from a non-expanded condition to a radially expanded condition. The dilator device is configured to support the stent thereon in the non-expanded condition and in predetermined orientation relative the deployment assembly. A rotational clutch assembly rotatably mounts the transition portion to a distal portion of the tubular shaft such that the deployment assembly is substantially torsionally isolated from the tubular shaft, about a longitudinal axis of the clutch assembly.

Abstract: A crack-resistant endoprosthesis for delivery in a body lumen can be comprised of a multilayered material. The multilayered material can include at least two layers having a boundary layer therebetween. The boundary layer is configured to inhibit cracks from propagating from a first layer-to a second layer. The different layers can be comprised of the same materials or different materials. It can be preferred that the multilayered material have layers that are comprised of resiliently-flexible materials, shape memory materials, and/or radiopaque materials.

Abstract: The present invention provides a stent comprising a tubular flexible body having a wall with a web structure that is expandable from a contracted delivery configuration to deployed configuration. The web structure comprises a plurality of neighboring, interconnected, web patterns, each web pattern composed of adjoining webs. Each adjoining web comprises a central section interposed between two lateral sections, forming concave or convex configurations. Embodiments of the present invention comprising curvature for tracking tortuous anatomy and reducing localized restoring forces are provided. Methods of using stents in accordance with the present invention are also provided.

Abstract: A device for treatment of mitral annulus dilation is disclosed, wherein the device comprises two states. In a first of these states the device is insertable into the coronary sinus and has a shape of the coronary sinus. When positioned in the coronary sinus, the device is transferable to the second state assuming a reduced radius of curvature, whereby the radius of curvature of the coronary sinus and the radius of curvature as well as the circumference of the mitral annulus is reduced.

Abstract: Disclosed is a fastener that can be mounted to a bone of a patient and can foreshorten and swell of a desired period of time. The fastener can include a head portion and a body portion extending from the head portion. At least one of the head portion and the body portion has a first width that changes to a second width greater than the first width and collectively the head portion and the body portion have a first length that changes to a second length shorter than the first length upon the head portion and the body portion being exposed to a temperature below a glass transition temperature of a polymeric material forming the head portion and the body portion.

Abstract: An implantable plate for providing support to a bone of a subject when affixed thereto includes a polymeric body comprised of a biocompatible polymer having a desired amount of polymer molecule orientation in a first direction so that the plate can be bent to conform with a contour of the bone of the subject. The polymeric body includes a top surface, a bottom surface, and at least one fastener portion. The fastener portion includes a recess and a fastener hold that is configured for receiving a fastener when affixed to the bone of the subject. A method of manufacturing the implantable plate includes: (1) injection molding a biocompatible polymeric composition into a polymeric body within an injection mold; (2) removing the polymeric body from the injection mold; and (3) forming at least one fastener hole within polymeric body.

Abstract: The invention includes a catheter having an elongate main body having a proximal section and a distal section. The elongate main body further includes a first guidewire lumen and a second guidewire lumen. Each guide wire lumen including a proximal port and a distal port in communication with an external environment. The proximal port of the first guidewire lumen spaced by a gap from the distal port of the second guidewire lumen. In accordance with a further aspect of the invention, the catheter includes a plurality of overlapping stiffening members defined along at least a portion of a length between the distal end and the proximal end of the elongate main body.

Abstract: Disclosed is an interventional device for delivery of therapeutic agents from an angioplasty balloon and from a prosthesis such as an intraluminal stent. The invention also relates to the method of loading the beneficial agents onto the balloon and the device, as well as the method of delivery of the agents from separate surfaces. The invention also relates to an interventional device having a prosthesis surface that is loaded with a first beneficial agent, and a balloon surface loaded with a second beneficial agent. The invention also relates to a method of loading multiple beneficial agents onto the prosthesis surfaces and the balloon surfaces, and to a method of manufacturing an interventional device for the delivery of a first beneficial agent and a second beneficial agent from separate surfaces.