Abstract: An intravascular catheter system for the treatment of occluded blood vessels that includes tissue displacement or hinged expansion members that are movable from a closed to an open position. An actuating assembly may be provided for moving the tissue expansion members between an open and closed position to exert a substantially lateral distal end force upon the region surrounding an occluded blood vessel. The tissue expansion members may stretch apart, tear or otherwise disrupt a vascular occlusion sufficiently to create a pathway that may support the passage or placement of a guidewire or an interventional vascular device across the occlusion or obstruction. Methods of crossing or displacing a vascular occlusion are further provided that include the positioning of a vascular catheter having at least one hinged spreading member positioned at the distal region of the catheter that is responsive to directed force along the longitudinal axis of the catheter.

Abstract: Methods and apparatus for crossing totally to substantially occluded blood vessels by passing a redirectable wire such as a guidewire from a relatively proximal point past the occlusion within a subintimal space formed between the intimal layer and the adventitial layer of a blood vessel wall. The wire may be advanced to a point distal to the occlusion, and thereafter deflected back into the blood vessel lumen, typically using a deflecting catheter which is advanced over the guidewire after it has been positioned within the subintimal space. The deflecting catheter may include a flapper valve assembly or preformed actuator wire for redirecting the guidewire. After the guidewire is returned to the blood vessel lumen, the deflecting catheter may be withdrawn, and the guidewire may be available for introduction of other interventional and diagnostic catheters for performing procedures such as stenting.

Abstract: A guidewire or a catheter for crossing vascular occlusions comprises a shaft having a proximal end and a distal end, and a drive member having a proximal and a distal end, the drive member being rotatably disposed within and along a longitudinal axis of the guidewire shaft. An actuator is connected to the proximal end of the drive member, the actuator imparting a rotation to the drive member. An asymmetrical rotating tip is attached to the distal end of the drive member and driven in rotation about the longitudinal axis of the shaft by the drive member. The rotating tip may include a protruding portion that projects from a plane defined by an outer surface of the guidewire shaft to render the rotating tip asymmetrical with respect to the longitudinal axis of the shaft. The protruding portion creates a volume of revolution as the asymmetrical tip rotates, which facilitates crossing a vascular occlusion by displacing and exerting pressure on stenotic material causing the occlusion.

Abstract: An apparatus is described for treating arterial occlusions combining an intraluminally operable catheter, having an occlusion-crossing working element, with a micro-invasive extraluminally operable locator for imaging the progress of the working element through the occlusion. Conical, abrasive, blunt-dissecting, and sharp-pointed, and steering and non-steering working elements including guide wires are described. Acoustic transducers and a flexible imaging tube are described for the locator. A suction cup is described for removably anchoring the imaging tube to a surface. A signal-emitting working element and cooperating signal-receiving locator are described. A method for treating arterial occlusions is described.

Abstract: Disclosed herein is an intravascular catheter system for crossing a severe or total arterial occlusion; particularly, a steerable intravascular catheter providing a working element and the optical guidance thereof in crossing an occlusion. Also disclosed is a method of crossing a severe or total arterial occlusion with a steerable catheter working element under optical guidance.

Abstract: Described herein is a catheter method and apparatus for the guided intraluminal bypass of a coronary occlusion. A method is described employing an intraluminally operable catheter shaft including an optionally steerable working element, combined with an extraluminally operable locator including an imaging device, to selectively direct the working element to create a fluid path from the artery proximal to the occlusion into the vein and further from the vein back into the artery distal to the occlusion, to perfuse myocardium distal to the occlusion. Methods are described for creating a fluid path from the artery proximal to the occlusion into an adjacent vein and thereafter either stent grafting the fluid path to the vein, directing arterial blood distally within the vein, or stenting the fluid path and occluding the vein proximal thereto, in either case arterializing the venous system distal to the stent or stent graft. A catheter shaft is described for creating and perfusing the fluid path.

Abstract: An intravascular catheter system for crossing a severe or total arterial occlusion includes a steerable intravascular catheter providing a working element and an optical guidance system. The optical guidance system is realized by an optical member with may include an imaging shaft that is rotated and measured by a motor/encoder assembly or which may include an optical switching device connected to a plurality of optical fibers. The working element may include a plurality of opening members that are actuated by an external plunger.

Abstract: Disclosed herein is a blunt end assembly including a catheter and a blunt end member. The blunt end member includes jaw sections which have a first closed position for locating the blunt end member at the site of the occlusion within the native lumen of the blood vessel and a second open position wherein the jaw sections are able to press against the interior walls of the lumen adjacent the occlusion. The assembly includes an actuation member for moving the jaw sections from the closed to the open positions repeatedly resulting in a fracturing of the occlusion. A guide wire may be thread through an internal opening in the catheter and the blunt end member and after fracturing, across the occlusion.

Abstract: Disclosed herein is manual actuator for retracting and advancing a therapeutic working element of an intravascular catheter system via an actuation shaft or one or more pulling wires. The manual actuator includes a hollow cylindrical bracing member having an open proximal end and a distal end, and a hollow cylindrical retracting member, the retracting member being slidable, in a telescoping fashion, into the open proximal end of the bracing member. An actuation shaft is secured near to the proximal end of the retracting member and the distal end of the actuation shaft is secured to the therapeutic working element. Alternatively, at least one pulling wire is secured proximal to the proximal end of the retracting member. The distal end of the pulling wire is secured to the therapeutic working element. At least one resilient connecting member has a proximal end attached proximate the proximal end of the retracting member, and a distal end attached proximate the distal end of the bracing member.