Abstract: Devices and methods are disclosed for widening a channel in a treatment site, the channel containing a guide-wire. The channel is widened by advancing an elongated dilation device, which is configured to fit tightly over the guide-wire at the distal tip of the dilation device and to provide a distal dilating surface, over the guide-wire and at least partially through the treatment site. The dilation device comprises a tubular metallic shaft, typically a metal inner tube, for providing sufficient stiffness and column strength for the dilator to be advanced at least partially through the channel, and a flexible sleeve providing a tapered distal tip. The distal end of the dilator defines a leading surface that is shaped to force away portions of a lesion surrounding the guide-wire away from the guide-wire as the distal end is advanced over the guide-wire through the lesion, whereby a channel through the lesion is at least partially dilated.

Abstract: Devices and methods are disclosed for widening a channel in a treatment site, the channel containing a guide-wire. The channel is widened by advancing an elongated dilation device, which is configured to fit tightly over the guide-wire at the distal tip of the dilation device and to provide a distal dilating surface, over the guide-wire and at least partially through the treatment site. The dilation device comprises a tubular metallic shaft, typically a metal inner tube, for providing sufficient stiffness and column strength for the dilator to be advanced at least partially through the channel, and a flexible sleeve providing a tapered distal tip. The distal end of the dilator defines a leading surface that is shaped to force away portions of a lesion surrounding the guide-wire away from the guide-wire as the distal end is advanced over the guide-wire through the lesion, whereby a channel through the lesion is at least partially dilated.

Abstract: Flexible sleeve having a leading (distal) edge that can be advanced over a conventional angioplasty guide-wire to facilitate balloon angioplasty catheter and stent catheter crossing complex coronary lesions such as chronic total occlusions or heavily calcified, non-compliant lesions.

Abstract: Flexible sleeve having a leading (distal) edge that can be advanced over a conventional angioplasty guide-wire to facilitate balloon angioplasty catheter and stent catheter crossing complex coronary lesions such as chronic total occlusions or heavily calcified, non-compliant lesions.

Abstract: A fastener system and method of inserting it, that includes a screw or bolt having two interleaved helical threads, which brackets or forms a groove for a helicoil. The helicoil expands and torques by various means to maintain hold and purchase between the screw coil combination and the substrate into which the screw and helicoil are inserted even when the substrate recedes a significant distance from the screw and helicoil combination. The fastener system includes means for latching the tilt of the coil so as to minimize the constraining forces and optimize the motion of the helicoil, that results in the screw or bolt being pushed into the substrate. The fastener may be actuated after it has been partly or completely turned into the substrate.

Abstract: A fastener system and method of inserting it, that includes a screw or bolt having two interleaved helical threads, which brackets or forms a groove for a helicoil. The helicoil expands and torques by various means to maintain hold and purchase between the screw coil combination and the substrate into which the screw and helicoil are inserted even when the substrate recedes a significant distance from the screw and helicoil combination. The fastener system includes means for latching the tilt of the coil so as to minimize the constraining forces and optimize the motion of the helicoil, that results in the screw or bolt being pushed into the substrate. The fastener may be actuated after it has been partly or completely turned into the substrate.

Abstract: An apparatus having a steerable distal end portion for insertion in a body lumen comprises a superlastic shape memory member which adopts a memorized shape in an unloaded austenitic state, and stationary heating means for heating at least a portion of the superlastic shape memory member to a temperature above the temperature inside the body lumen. Heating the superlastic shape memory member inside the body lumen causes it to increase in stiffness and tend toward the memorized shape, and subsequent discontinuation of heating causes the superlastic shape memory member to decrease in stiffness, allowing the distal end portion to be deformed from the memorized shape, thereby resulting in movement of the distal end portion which assists in steering it through the body lumen. Preferably, the elongate shape memory member is tubular, having a lumen extending therethrough, and the heating means comprises electrical heating means.

Abstract: The apparatus includes a flexible, elongated tubular member and is comprised of a tube of superlastic metal which in response to changing temperatures resists to a greater or less degree the bending moment imposed by a biasing element, thereby altering the shape of the tubular member as a function of temperature and producing a broad range of shapes.

Abstract: An apparatus having a steerable distal end portion for insertion in a body lumen comprises a superlastic shape memory member which adopts a memorized shape in an unloaded austenitic state, and stationary heating means for heating at least a portion of the superlastic shape memory member to a temperature above the temperature inside the body lumen. Heating the superlastic shape memory member inside the body lumen causes it to increase in stiffness and tend toward the memorized shape, and subsequent discontinuation of heating causes the superlastic shape memory member to decrease in stiffness, allowing the distal end portion to be deformed from the memorized shape, thereby resulting in movement of the distal end portion which assists in steering it through the body lumen. Preferably, the elongate shape memory member is tubular, having a lumen extending therethrough, and the heating means comprises electrical heating means.

Abstract: A stent radially expandable from a radially contracted introduction state into a radially expanded position state, in which the final shape of the stent can be controlled by varying the amount and places photo-thermal energy is projected onto the interior surfaces of the tubes from which the stent is fabricated.

Abstract: A system for guiding devices or materials into body lumens includes a guidewire made of a shape memory alloy (SMA) or other shape memory material and having a lumen; an energy guide, preferably an optical fiber, received in the lumen; and a catheter or device slidably attached to the guidewire. The guidewire has a memorized shape and is in a martensitic (deformable) state during insertion into the body lumen. During or after insertion of the guidewire into the body lumen, the energy guide produces localized heating of the inner surface of the distal end of the guidewire, to cause the guidewire to at least partially recover its memorized shape, thereby selectively changing the shape, radii of curves, and rigidity of part or all of the guidewire. This selective shaping of the guidewire reduces fouling and facilitates delivery of devices along the guidewire.

Abstract: Tubes made from shape memory alloy (SMA) assume their original shape when heated to their austenite finish temperature by directing photo-thermal or electrical energy inside parts of the tube using an optical fiber or conductors, the remainder of the tube acting as a heat sink. Using this method of photo-thermal heating or joule heating, virtually any predetermined shape can be made from tubes, or objects having tubular passages, in a controlled manner with very little heat being transferred to the material surrounding the outside of the tube. The optical fiber may also be used to detect the transformation of the material at the heated site from martensite to austenite and the temperature of the heated site, and use this information to control deployment of the device and reduce overheating of the tube and the material surrounding the outside of the tube.