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: 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: 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 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 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: A device for closing an opening in tissue includes a shaft having a proximal end, a distal end, and a channel disposed between the proximal and distal ends. A pair of pins are disposed within the channel and cooperate with a slidable and axially movable foot. The foot extends distally from the channel with a flexible guidebody extending from a distal foot end of the foot.

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 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 device for closing an opening in tissue includes a shaft having a proximal end, a distal end, and a channel disposed between the proximal and distal ends. A pair of pins are disposed within the channel and cooperate with a slidable and axially movable foot. The foot extends distally from the channel with a flexible guidebody extending from a distal foot end of the foot.

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, a cutter near the distal end of the catheter body, a drive shaft connected to the cutter and extending within the catheter body, an imaging element near the distal end of the catheter body and an imaging shaft connected to the imaging element and extending within the catheter body. The cutter and the imaging element are mechanically isolated, and the drive shaft is configured to be axially translated relative to the imaging shaft and the catheter body.

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 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: 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 device for closing an opening in tissue includes a shaft having a proximal end, a distal end, and a channel disposed between the proximal and distal ends. A pair of pins are disposed within the channel and cooperate with a slidable and axially movable foot. The foot extends distally from the channel with a flexible guidebody extending from a distal foot end of the foot.

Abstract: A device for closing an opening in tissue includes a shaft having a proximal end, a distal end, and at least one pin associated with a distal end the shaft. A flexible guidebody extends from the distal end of the shaft, while a foot associated with the device is movable with respect to the shaft through the pin connected to at least one slot of the foot. Another device for closing an opening in tissue includes a shaft having a proximal end and a distal end. A plurality of feet are disposed proximate the distal end of the shaft, the plurality of feet being movable with respect to the shaft. The device further includes a flexible guidebody extending from the distal end of the shaft.

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: A system for imaging a body lumen includes a controller and a display. The controller is configured to connect to a proximal end of a catheter having an optical fiber extending along the length of an elongate catheter body. The controller is further configured to rotate a distal end of the optical fiber from a location near a proximal end of the elongate catheter body, acquire optical coherence tomography (OCT) images using the optical fiber as the distal end of the optical fiber rotates, and determine a rotational lag of the distal end of the optical fiber. The display is configured to display one or more OCT images corrected for the rotational lag.

Abstract: Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot near a distal end of a shaft is inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot carries suturing attachment cuffs, and needles are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cross-section of the shaft within the tissue tract can be minimized by laterally deflecting the needles as they leave the shaft, while tapered depressions within the foot can guide the advancing needles into engagement with the cuffs. The cuffs lockingly engage the needles and can be withdrawn proximally along the needle paths and through the tissue tract so as to form a loop of suture across the puncture.