Abstract: A catheter device for crossing occlusions includes an elongate body, a central lumen extending within the elongate body from the proximal end to the distal end, a rotatable tip at the distal end of the elongate body, and an OCT imaging sensor. The rotatable tip is configured to rotate relative to the elongate body. The OCT imaging sensor includes an optical fiber coupled with the rotatable tip and configured to rotate therewith. A distal end of the elongate body includes one or more markers configured to occlude the OCT imaging sensor as it rotates. A fixed jog in the elongate body proximal to the distal end of the catheter positions the distal end of the catheter at an angle relative to the region of the catheter proximal to the fixed jog and is aligned with the one or more markers on the elongate body.

Abstract: A system for optical coherence tomography includes a source of optical radiation, an optical fiber, and a graded index fiber attached to a distal end of the optical fiber. The optical fiber and the graded index fiber are together configured to provide a common path for optical radiation reflected from a reference interface at a distal end of the graded index fiber and from a target.

Abstract: Described herein are atherectomy catheters, systems and methods that include a distal tip region that may be moved laterally so that its long axis is parallel with the long axis of the main catheter body axis. Displacing the distal tip region laterally out of the main catheter body axis exposes an annular blade and opens a passageway for cut tissue to enter a storage region within the catheter. The annular blade may be internally coupled to a drive shaft that rotates the blade, and thus the exposed blade edge may have the same crossing profile (OD) as the rest of the distal end region of the catheter. Also described herein are gear-driven atherectomy devices that may use a cable drive shaft to actuate the annular blade. Both push-to-cut and pull-to-cut variations are described, as are methods for cutting tissue and systems including these atherectomy catheters.

Abstract: Atherectomy catheter devices having a C-shaped balloon opposite a cutting window out of which a rotating cutter may extend and a proximal annular balloon. The C-shaped first balloon may be used to drive the cutter against a vessel and to deploy the cutter by assisting in deflecting a nosecone (distal tip) to expose the distal-facing cutting edge of the cutter. The proximal annular balloon may be used to occlude blood flow. The device may pulled, pushed or rotated in a vessel with the balloons inflated or deflated.

Abstract: Described herein are methods for producing and identifying characteristic (“crescent shaped”) regions indicative of an atherectomy plaque within a vessel, and systems and devices adapted to take advantage of this characteristic region.

Abstract: A drive assembly for driving an imaging catheter has a rotatable fiber and a rotatable drive shaft. The drive assembly includes a fiber optic rotating junction and a motor configured to rotate the rotatable portion of the fiber optic rotating junction. In some embodiments, the drive assembly includes a sensor configured to detect a rotational position of the fiber optic rotating junction and a processor configured to obtain the detected rotational position and stop the motor only when the fiber optic rotating junction is in a predetermined rotational position. In some embodiments, the motor includes a hollow shaft through which at least a portion of the fiber optic rotating junction extends.

Abstract: Described herein are atherectomy catheters, systems and methods that include longitudinally displaceable drive shafts that drive actuation of one or more cutters at the distal end of the catheter. The catheters described herein may include one or more imaging sensors for imaging before, during or after cutting tissue. In some variations the imaging sensor may be rotated around the perimeter of the catheter independently of the rotation of the cutter. Also describe herein are imaging catheters that may be used without cutters.

Abstract: A catheter device for crossing occlusions includes an elongate catheter shaft, a rotatable tip configured to rotate relative to the elongate catheter shaft, a drive shaft, and an OCT imaging sensor. The rotatable tip includes a housing coupled with the elongate catheter shaft and cutting wedges extendable from the housing. The drive shaft has a central lumen extending therethrough and extends within the elongate catheter shaft. The drive shaft is coupled with the wedges and is configured to rotate the rotatable tip. The OCT sensor includes an optical fiber coupled with the rotatable tip and configured to rotate therewith. The elongate catheter shaft is configured to move axially over the drive shaft to extend and retract the wedges from the housing while maintaining a fixed position of the imaging sensor relative to the cutting wedges.

Abstract: Catheter-based Optical Coherence Tomography (OCT) systems utilizing an optical fiber that is positioned off-axis of the central longitudinal axis of the catheter have many advantage over catheter-based OCT systems, particularly those having centrally-positioned optical fibers or fibers that rotate independently of the elongate body of the catheter. An OCT system having an off-axis optical fiber for visualizing the inside of a body lumen may be rotated with the body of the elongate catheter, relative to a handle portion. The handle may include a fiber management pathway for the optical fiber that permits the off-axis optical fiber to rotate with the catheter body relative to the handle. The system may also include optical processing elements adapted to prepare and process the OCT image collected by the off-axis catheter systems described herein.

Abstract: An atherectomy catheter includes an elongate flexible catheter body, an elongate deflectable distal tip coupled to the catheter body at a hinge point, a rotatable cutter near the distal end of the catheter body, and a drive shaft extending within the catheter body and configured to rotate the cutter. The atherectomy catheter further includes an optical fiber extending through the drive shaft substantially on-axis with the catheter body and attached to the cutter. The optical fiber is configured to rotate with the drive shaft. The atherectomy catheter further includes a wedge configured to deflect the distal tip away from the catheter body at the hinge point upon axial movement of the drive shaft.

Abstract: A system for optical coherence tomography includes a source of optical radiation, an optical fiber, and a graded index fiber attached to a distal end of the optical fiber. The optical fiber and the graded index fiber are together configured to provide a common path for optical radiation reflected from a reference interface at a distal end of the graded index fiber and from a target.

Abstract: Described herein are guidewire positioning and support devices, method for using them, method of treating a subject using them, and systems including such guidewire positioning and support devices. These devices typically include a rotatable distal tip region that may include one or more wedges. The wedges may be extendable from the rotatable distal tip. The distal end of the device may be steerable, and may be steered while still rotating the distal end of the device. The wedges (which may include sharp forward-cutting blades and blunt lateral portions) can be extended from the distal housing and locked in any position (extended, partially extended or retracted) and rotated clockwise and/or counterclockwise while locked in a retracted, extended or partially extended position. The distal region of the device may also be controllable steered from the proximal end of the device.

Abstract: The present invention relates to: (1) guidewire support/placement catheters; (2) support/placement catheters with imaging; (3) atherectomy catheters, (4) atherectomy catheters with imaging, (5) occlusion crossing catheters, and (6) occlusion crossing catheters with imaging as well as methods for using them to treat disorders (and particularly peripheral artery disease) and systems including them.

Abstract: The present invention relates to methods and devices for predicting restenosis, and for treating atherosclerosis to prevent or reduce the incidence of restenosis. Methods of predicting restenosis in a stenosed peripheral artery may include quantitative histology of the vessel. For example, a method of treating a stenosed artery (and particularly a peripheral artery) may include the steps of determining a level of hypercellularity and one or more of the lipid-richness and extent of inflammatory cell inclusion in the tissue. An index of restenosis based on the hypercellularity and lipid richness and/or extent of inflammatory cell inclusion in the tissue may be determined. Systems for treating or preventing restenosis may include one or more imaging modalities for imaging tissue regions and determining the level of hypercellularity and one or more of the degree of lipid-richness and the extent of inflammatory cell inclusion in the tissue region.

Abstract: A rotating cutting head catheter for passage through chronic total occlusions or other refractory atherosclerotic plaque from diseased arteries is disclosed. The catheter's rotating cutting head is designed to reside safely within an outer protective sheath when not in use. The outer protective sheath contains one or more helical grooves or slots, and the cutting head contains protruding blades or projections that fit into these helical grooves or slots. Application of torque to an inner catheter or wire attached to the cutting head applies spin to the cutting head, and the force of the sheath's helical grooves or slots against the cutting head's protruding blades or projections advances the cutting head outward from the protective sheath. Once extended, the cutting head may now rotate freely. The device may use a guidewire to direct the cutting head to the desired position.

Abstract: A rotating cutting head catheter for passage through chronic total occlusions or other refractory atherosclerotic plaque from diseased arteries is disclosed. The catheter's rotating cutting head is designed to reside safely within an outer protective sheath when not in use. The outer protective sheath contains one or more helical grooves or slots, and the cutting head contains protruding blades or projections that fit into these helical grooves or slots. Application of torque to an inner catheter or wire attached to the cutting head applies spin to the cutting head, and the force of the sheath's helical grooves or slots against the cutting head's protruding blades or projections advances the cutting head outward from the protective sheath. Once extended, the cutting head may now rotate freely. The device may use a guidewire to direct the cutting head to the desired position.