Avinger, Inc.

An atherectomy catheter includes an elongate catheter body, a cutter at a distal end of the catheter body, and a nosecone attached to a distal end of the catheter body. The cutter is configured to excise tissue from the body. The nosecone is configured to hold tissue excised from the cutter. The nosecone includes a distal section, a proximal section, and a connection mechanism that is configured to allow the distal section to attach and detach from the proximal section during use. The distal section includes a plug configured to sit within an inner diameter of the proximal section when the proximal section is connected to the distal section.

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.

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.

System and methods for optical coherence tomography. The systems may include a source of optical radiation, an optical fiber, a detector, an interface medium, a mirror in the embedding medium, and a processor. The optical fiber may provide a common path for optical radiation reflected from a reference and a target. The detector may receive the optical radiation reflected from the reference and the target. The interface medium may be at the reference interface and in optical contact with the distal end of the optical fiber. The mirror may include a silicon die having a reflective coating. The processor may generate an image of the target based upon the optical radiation received by the detector.

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.

An atherectomy device including a catheter body, a nosecone and a driveshaft. The catheter body may include a fixed jog section having a fixed curvature, and a flexible section having a greater lateral flexibility than the fixed jog section. The flexible section may include circumferential slits that are configured to allow the flexible section to passively bend in multiple directions. The nosecone may be attached to a distal end of the catheter body. The driveshaft may be configured to rotate within the catheter body and to move distally and proximally within the catheter body. A distal end of the driveshaft may include an annular cutter.

Occlusion crossing devices. An outer shaft can include a distal opening that is angled relative to a central axis of the outer shaft to form a tapered distal end. An inner shaft can be configured to translate within the outer shaft and to rotate with respect to the outer shaft. The inner shaft can include a distal end having cutting edges. The inner shaft can include an imaging window on a lateral side of the inner shaft proximal to the cutting edges. When at last a portion of the cutting edges are fully extended distally through the distal opening of the outer shaft, the tapered distal end of the outer shaft can be arranged to occlude the imaging window at a defined rotational position as the inner shaft is rotated relative to the outer shaft to provide a registration mark for imaging.

An atherectomy catheter for use in a vessel includes a catheter and a rotatable cutter. The rotatable cutter can be translatable within the catheter to extend the cutter through a window of the catheter or retracted the cutter within the catheter. The catheter can have a fixed bend and/or have a shapeable portion configured to facilitate positioning and movement of the cutter. The shapeable portion may take on a pre-defined shape. The shapeable portion may be positioned against an inner wall of a blood vessel to provide leverage for the rotatable cutter. In some cases, a rotation limiter may limit the number of rotations that the catheter can rotate with respect to a guidewire to prevent twisting of the guidewire.

Systems and methods of optical coherence tomography. The systems may include a source of optical radiation, an elongate catheter body, an optical fiber, a handle, a detector and a processor. The optical fiber may extend from a proximal end to a distal end of the elongate catheter body, and be fixed to the distal end of the elongate catheter body. The optical fiber may provide a common path for radiation reflected from a reference and a target. The handle may be attached to the proximal end of the elongate catheter body and be configured to allow rotation of the elongate catheter body and the optical fiber relative to the handle about a longitudinal axis. The detector may be configured to receive the radiation reflected from the reference and the target. The processor may be configured to generate an image of the target based upon the radiation received by the detector.

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.