Abstract: Disclosed are methods for crimping a medical device, such as a stent, wherein the medical device is formed of a superelastic alloy. A method for crimping a medical device includes cooling the stent until the alloy becomes martensitic, allowing the stent to warm after cooling, crimping the stent with a crimping apparatus.

Abstract: An apparatus and method are provided for simultaneously electropolishing a plurality of metallic stents. A plurality of elongated members on the apparatus are movably engaged with a plate such that movement of the plate relative to the elongated members causes each of the elongated members to rotate on its respective longitudinal axis when immersed in an electrolytic solution. A continuous cathode is located in close proximity to each of the elongated members when they are immersed in the electrolytic solution.

Abstract: A generally spherical vascular remodeling device is permanently positionable at a junction of afferent and efferent vessels of a bifurcation having an aneurysm. After positioning the device at the junction to substantially conform the device to the shape of the junction, the device acts as a scaffolding to inhibit herniation of objects out of the aneurysm and the device permits perfusion to the efferent vessels. Positioning the device may include deployment and mechanical or electrolytic release from a catheter. Embolic material may be inserted in the aneurysm before or after positioning the device. The device may have a first end, a second end substantially opposite to the first end, and a plurality of filaments extending between and coupled at the first end and the second end. Such devices may be football shaped, pumpkin shaped, or twisted. The device may include a plurality of loops forming a generally spherical shape.

Abstract: A stent having a body capable of visualization under X-ray fluoroscopic techniques. The stent body includes radiopaque strut members. The stent body can also have a radiopacity gradient along the length of the stent body.

Abstract: An endoprostheses for implanting in a body lumen, such as a coronary artery, peripheral artery, or other body lumen includes a plurality of elongate strut members spaced apart and extending along a longitudinal axis, each elongate strut member having a plurality of alternating peaks and valley. At least one flexible connecting link connects each elongate strut member to an adjacent elongate strut member. The elongate strut members and connecting links forming a generally tubular stent body having a first delivery diameter and a second implanted diameter. The positioning of the connecting links along the stent body produces desired stent performance characteristics.

Abstract: A modular endoprosthesis is configured to have improved flexibility during and after deployment by having separate endoprosthetic modules that are interconnected by flexible interconnectors. The modular endoprosthesis includes a plurality of separate endoprosthetic modules positioned adjacently so that a first end of a first endoprosthetic module is adjacent to an end of a second endoprosthetic module and a second end of the first endoprosthetic module is adjacent to an end of a third endoprosthetic module. Additionally, the modular endoprosthesis includes a plurality of flexible interconnectors coupled to the plurality of separate endoprosthetic modules so as to interconnect the first end of the first endoprosthetic module with the end of the second endoprosthetic module with a first flexible interconnector, and interconnect the second end of the first endoprosthetic module with the end of the third endoprosthetic module with a second flexible interconnector.

Abstract: Disclosed are methods for crimping a medical device, such as a stent, wherein the medical device is formed of a superelastic alloy. A method for crimping a medical device includes cooling the stent until the alloy becomes martensitic, allowing the stent to warm after cooling, crimping the stent with a crimping apparatus.

Abstract: Methods for forming a support frame for flexible leaflet heart valves from a starting blank include converting a two-dimensional starting blank into the three-dimensional support frame. The material may be superelastic, such as NITINOL, and the method may include bending the 2-D blank into the 3-D form and shape setting it. A merely elastic material such as ELGILOY may be used and plastically deformed in stages, possibly accompanied by annealing, to obtain the 3-D shape. Alternatively, a tubular blank could be formed to define a non-tubular shape, typically conical. A method for calculating the precise 2-D blank shape is also disclosed. A mandrel assembly includes a mandrel and ring elements for pressing the blank against the external surface of the mandrel prior to shape setting.

Abstract: A superelastic endoprosthesis can have improved fatigue resistance, and improved resistance to crack formation by being configuring to have an austenitic finish temperature from about 5 degrees Celsius to about 35 degrees Celsius, a stress-strain curve having an upper plateau stress from about 40 ksi to about 80 ksi, and a lower plateau stress from about 5 ksi to about 50 ksi. Such an endoprosthesis may be fabricated by heating at least a portion of the endoprosthetic body in a fluid, such as air, salt bath, or fluidized sand, having a temperature from about 400 degrees Celsius to about 600 degrees Celsius for at least about 30 seconds. Additionally, only portions of an endoprosthesis may selectively be subjected to the heating parameters of the present invention such that the endoprosthesis exhibits an increased radial stiffness and an increased flexibility in the longitudinal direction.

Abstract: An apparatus and method are provided for simultaneously electropolishing a plurality of metallic stents. A plurality of elongated members on the apparatus are movably engaged with a plate such that movement of the plate relative to the elongated members causes each of the elongated members to rotate on its respective longitudinal axis when immersed in an electrolytic solution. A continuous cathode is located in close proximity to each of the elongated members when they are immersed in the electrolytic solution.

Abstract: Methods are provided for descaling metallic components devices such as stents. The devices or components are cleaned under ultrasound in a cleaning solution of ammonium hydrogen fluoride at a temperature within a range of about 60° to 80° C., then rinsed at that temperature with an aqueous rinse containing a nonionic surfactant and rinsed again with purified water.

Abstract: A method of making a medical device which is at least partially bio-erodible and which exhibits controlled elution of therapeutic agent.

Abstract: A medical device which is at least partially bio-erodible and which exhibits controlled elution of therapeutic agent.

Abstract: Methods for forming a support frame for flexible leaflet heart valves from a starting blank include converting a two-dimensional starting blank into the three-dimensional support frame. The material may be superelastic, such as NITINOL, and the method may include bending the 2-D blank into the 3-D form and shape setting it. A merely elastic material such as ELGILOY may be used and plastically deformed in stages, possibly accompanied by annealing, to obtain the 3-D shape. Alternatively, a tubular blank could be formed to define a non-tubular shape, typically conical. A method for calculating the precise 2-D blank shape is also disclosed. A mandrel assembly includes a mandrel and ring elements for pressing the blank against the external surface of the mandrel prior to shape setting.

Abstract: Methods and apparatuses for testing the compliance of stents and stented grafts, including pre-testing them in a pre-tester tube prior to accelerated fatigue testing. The pre-tester tube is a simulated human vessel that may be made of animal tissue having approximately the same size as the human target vessel. The pre-test involves pressurizing the pre-tester tube at various normal and abnormal physiologic pulsed pressures with the stent or stented graft in place. By measuring the expansion of the pre-tester tube, the proper expansion rate of the stent or stented graft is determined. Those data are then used in a feedback loop to control the amount of expansion of a synthetic tester tube in the accelerated fatigue tests. The tester regulates the pressure in the tester tube to attain the proper expansion magnitude during the test. The animal tissue may be porcine tissue, in particular a porcine aorta to simulate the human abdominal aorta. Any side branches of the porcine aorta are tied off.