Abstract: A catheter for delivering an agent to an injection site in a wall of a patient's body lumen, with an elongated shaft having a needle-through lumen slidably containing a needle therein, and an expandable member on the distal shaft section which has a collapsed configuration and a radially expanded configuration. In the radially expanded configuration, the expandable member supports the shaft in a position spaced away from the body lumen wall, and the needle slidably exits the needle-through lumen in the extended configuration through the port spaced away from the body lumen wall as a portion of the expandable member maintains the position of the port section of the shaft in the body lumen. The expandable member typically has an open-walled, helical, or lobed configuration providing a perfusion path along the expandable member.

Abstract: A fluid bearing assembly provides support to stent tubing while the stent tubing is undergoing laser cutting to form a stent pattern. The fluid bearing assembly supports the stent tubing and provides a fluid barrier between the bearing and the stent tubing thereby providing nearly frictionless movement between the support bearing and the stent tubing.

Abstract: A laser cutting system including a chamber configured to provide a controlled environment while the laser is being used to cut a pattern into a material to reduce or eliminate heat and oxygen related changes to the mechanical characteristics of the material. A system for providing a gas to the controlled environment within the chamber, as well as a means for exhausting gas and cutting debris from the chamber is also described. A cutting mandrel that provides for flow of a shielding gas and also provides a means for dispersing a laser beam before it can produce unwanted damage to a section of tubing is also described.

Abstract: Devices and methods for treating veins and venous conditions, such as chronic cerebrospinal venous insufficiency, are provided. In one aspect, the disclosed subject matter provides an intraluminal scaffold having a generally tubular body with a lumen defined therethrough, the tubular body having a compressed condition for delivery and an expanded condition for implant within a vessel having a distended portion, at least a length of the tubular body configured to form an enlarged portion in the expanded condition to engage a wall of the distended portion of the vessel. Methods for fabricating and using the scaffold, methods for remodeling a vein, and methods of deploying a medical device in a vessel without negatively impacting the function of a valve of the vessel, are also provided.

Abstract: The present invention provides an intraluminal stent delivery catheter device having improved stent retention. Particularly, the present invention is directed to a catheter having an expandable member and a fibrous matrix positioned over the expandable member and a stent mounted on the outer surface of the fibrous matrix. The fibrous matrix provides mechanical interface for improved stent retention, delivery and deployment.

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.

Abstract: Radiopaque marker for a catheter includes a collar having a ring shape defining a longitudinal center axis therethrough and at least one helical member extending longitudinally from the collar. A second collar can be provided spaced longitudinally from the first collar. Additionally, a second helical member can extend longitudinally from the collar and be coaxially intertwined with the first helical member in a double helical configuration. The helical member can define a compression spring structure having longitudinal, transverse, and torsional flexibility. A catheter having such a marker and a method of making the marker are also provided.

Abstract: Medical device system comprising a catheter including an elongate tubular member having an inner wall surface defining a lumen extending longitudinally through at least a portion of the tubular member. The medical device also includes an inner stop extending inwardly from the inner wall surface of the tubular member at a distal end section of the catheter and a pusher device insertable into the lumen. The pusher device has a contact surface to abut the inner stop of the tubular member.

Abstract: The present invention relates to a medical device or implant made at least in part of a high strength, low modulus metal alloy comprising Niobium, Tantalum, and at least one element selected from the group consisting of Zirconium, Tungsten, and Molybdenum. The medical devices according to the present invention provide superior characteristics with regard to bio-compatibility, radio-opacity and MRI compatibility.

Abstract: A system and method for precision cutting using multiple laser beams is described, The system and method includes a combination of optical components that split the output of a single laser into multiple beams, with the power, polarization status and spot size of each split beam being individually controllable, while providing a circularly polarized beam at the surface of a work piece to be cut by the laser beam. A system and method for tracking manufacture of individual stents is also provided.

Abstract: The present invention relates to a surgical catheter, and more particularly, a balloon catheter having an auxiliary lumen configured to permit the advancement of a functional measurement wire to a treatment site. The auxiliary lumen communicates with a working lumen that is configured to permit the advancement of a guidewire and the functional measurement wire, so that the guidewire and functional measurement wire may selectively be advanced to the treatment site during a surgical procedure.

Abstract: A tissue closure device includes a main body, a sheath, and a biasing member. The main body has a plurality of resilient arms that each extend from a proximal end to a distal tip. The resilient arms are movable between an open configuration in which the distal tips are radially spaced apart from the longitudinal axis of the main body and from each other and a closed configuration in which the distal tips abut one another at or near the longitudinal axis. The sheath is longitudinally slideable on the main body to move the arms between the open and closed configurations. The biasing member causes the sheath to bias the arms toward the closed configuration.

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.

Abstract: Devices, systems and methods are described which control blood pressure and nervous system activity by stimulating baroreceptors. By selectively and controllably activating baroreceptors and/or nerves, the present invention reduces blood pressure and alters the sympathetic nervous system; thereby minimizing deleterious effects on the heart, vasculature and other organs and tissues. A baroreceptor activation device or other sensory activation device is positioned near a dermal bone to provide the treatment.

Abstract: A stent and method for manufacturing a stent that achieves both strength as well as ductility. In the manufacturing process, the material used to form the stent is only partially annealed to lower the grain size across the thickness of the stent. The material is partially annealed either prior to or after the cutting a stent pattern into a tube.

Abstract: The present disclosure is directed to tantalum-alloy products, implantable medical devices that incorporate tantalum-alloy products such as stents or other implantable medical devices, methods of making and/or processing the tantalum-alloy products and implantable medical devices, and methods of using the implantable medical devices. In an embodiment, a stent includes a stent body having a plurality of struts. At least a portion of the stent body is made from a tantalum alloy. The tantalum alloy includes a tantalum content of about 77 weight % (“wt %”) to about 92 wt %, a niobium content of about 7 wt % to about 13 wt %, and a tungsten content of about 1 wt % to about 10 wt %. The tantalum alloy exhibits at least one mechanical property modified by heat treatment thereof, such as yield strength, ultimate tensile strength, or ductility.

Abstract: The present disclosure is directed to a drug-eluting implantable medical devices that includes a tantalum-alloy body having a drug-eluting coating thereon for delivering a drug to treat, for example, restenosis. In an embodiment, an implantable medical device includes a body sized and configured to be implanted in a living subject. At least a portion of the body may comprise a tantalum alloy. The tantalum alloy includes a tantalum content of about 77 weight % (“wt %”) to about 92 wt %, a niobium content of about 7 wt % to about 13 wt %, and a tungsten content of about 1 wt % to about 10 wt %. The tantalum alloy exhibits at least one mechanical property modified by heat treatment thereof. The body has a drug-eluting coating thereon.

Abstract: Embodiments of methods for vacuum heat treating refractory metal articles (e.g., implantable medical devices), and heat treating apparatuses for use in such methods are disclosed. Heat treating refractory metal articles under high vacuum (e.g., 10?6 Torr) may improve strength and ductility and remove material contaminants (e.g., oxygen or hydrogen) that may be absorbed during manufacturing processes. Heat treating methods include disposing a refractory metal article in a heat treating apparatus, drawing a vacuum therein, and moving the article to a heated zone in the furnace using a drive system that permits movement of the article while the vacuum is maintained in the apparatus. A heat treating apparatus may include an elongate furnace tube that may be sealed and placed under vacuum, a heating element disposed around at least a portion of the tube, and a drive system configured for moving articles disposed inside the furnace tube while under vacuum.

Abstract: The present invention relates to a medical device or implant made at least in part of a high strength, low modulus metal alloy comprising Niobium, Tantalum, and at least one element selected from the group consisting of Zirconium, Tungsten, and Molybdenum. The medical devices according to the present invention provide superior characteristics with regard to bio-compatibility, radio-opacity and MRI compatibility.

Abstract: A reinforcement region is formed within the myocardium by introducing a delivery device through a vessel wall to a treatment site within a myocardium. A biomaterial is then delivered to the treatment site as the delivery device is withdrawn from the treatment site to form the reinforcement regions. Formation of the reinforcement region may further include introducing a delivery device through a vessel wall to a region within a myocardium such that the delivery device is positioned within the myocardium substantially parallel to a wall of the myocardium. A biomaterial may be delivered into a space formed within the region by the delivery device. The reinforcement region may be formed around an infarct tissue region of a myocardium to reinforce the damaged tissue.