Abstract: The present invention relates to a delivery system for delivering a device for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart. The delivery system has an elongate member having a proximal and distal end. A deflectable needle assembly having luminal and abluminal surfaces is slideably engaged within the elongate member. An actuator is slideabley engaged within the elongate member and attached to the needle tip assembly such that translational movement of the actuator causes deflection of the deflectable needle assembly.

Abstract: A device for deploying a mechanical closure device for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart. The deployment device has a first tubular structure having proximal and distal ends. A second tubular structure is substantially coaxial to and slideably engaged within the first tubular structure. The second tubular structure has a first substantially linear shape when constrained within the first tubular structure, and a second curvilinear shape when telescopically extended from the distal end of the first tubular structure. A third tubular structure is substantially coaxial to and slideably engaged within the second tubular structure. The third tubular structure is configured to provide sufficient rigidity to push the mechanical closure device from the distal end of the second tubular structure, and provide sufficient flexibility to assume a curvilinear shape when deflected by the second tubular structure.

Abstract: The present invention is directed to the fabrication of a test apparatus and the test apparatus itself. The test apparatus is designed to be a component used in a durability/fatigue testing unit.

Abstract: A biocompatible material may be configured into any number of implantable medical devices including intraluminal stents. The biocompatible material may comprise metallic and non-metallic materials. These materials may be designed with a microstructure that facilitates or enables the design of devices with a wide range of geometries adaptable to various loading conditions.

Abstract: Systems and methods for fatigue testing one or more stents based on measured electrical resistance levels of each stent. Pairs of lead lines from an ohmmeter are connected to a respective stent. The respective stent is mounted onto an expander having an interior tapered portion into which a correspondingly tapered expansion pin is received. Cyclic loading strains are applied to the respective stent as an expansion pin is inserted into a corresponding one of the expanders. Stent fracture or failure occurs when cyclic loading exceeds the stents architectural and material capacity. Such fracture fatigue or failure is identified by increased electrical resistance levels. Resistance may be continuously monitored to more readily identify the onset of fatigue or failure. The expansion pins extend from a movable plate, and the expanders comprise a part of corresponding stations that extend from a fixed plate.

Abstract: Systems and methods for fatigue testing one or more stents based on measured electrical resistance levels of each stent. Pairs of lead lines from an ohmmeter are connected to a respective stent. The respective stent is mounted onto an expander having an interior tapered portion into which a correspondingly tapered expansion pin is received. Cyclic loading strains are applied to the respective stent as an expansion pin is inserted into a corresponding one of the expanders. Stent fracture or failure occurs when cyclic loading exceeds the stents architectural and material capacity. Such fracture fatigue or failure is identified by increased electrical resistance levels. Resistance may be continuously monitored to more readily identify the onset of fatigue or failure. The expansion pins extend from a movable plate, and the expanders comprise a part of corresponding stations that extend from a fixed plate.

Abstract: The present invention is directed to the fabrication of a test apparatus and the test apparatus itself. The test apparatus is designed to be a component used in a durability/fatigue testing unit. One such test apparatus made in accordance with the present invention is a life-size model of an Abdominal Aortic Aneurysm made with any rapid prototyping process that creates solid freeform parts with flexible material. A preferred rapid prototyping process used to make the AAA model in accordance with the present invention is the process known as selective laser sintering (SLS), while the preferred material used in said process is an elastomeric polymer.

Abstract: A solid-solution alloy may be formed into any number of implantable medical devices such as intraluminal scaffolds. The biocompatible, solid-solution alloy comprises a combination of elements in specific ratios that improve its fatigue resistance while retaining the characteristics required for intraluminal scaffolds. The biocompatible, solid-solution alloy is an essentially carbon free cobalt-chromium-molydenum metallic material.

Abstract: A biocompatible solid-solution alloy may be formed into any number of implantable medical devices. The solid-solution alloy comprises a combination of elements in specific ratios that make it magnetic resonance imaging compatible while retaining the characteristics required for implantable medical devices. The biocompatible solid-solution alloy is a Cobalt-Chromium alloy having substantially reduced Iron, Silicon, Phosphorous and Sulfur content.