Abstract: 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.

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 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: 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.

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: Occlusion crossing devices and systems. An inner shaft may be configured to rotate and extend within an outer shaft. The inner and outer shafts may include engagement regions to limit distal movement of the inner shaft within the outer shaft. The outer shaft may include a distal opening that is angled to form a tapered distal end. The inner shaft may include a distal end having a fluted tip with cutting edges that are configured to extend through the distal opening of the outer shaft. The inner shaft may include an imaging window. When the cutting edges are fully extended distally through the distal opening of the outer shaft, the tapered distal end of the outer shaft may be configured 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.

Abstract: An atherectomy catheter for use in a vessel includes a catheter body, a nosecone and an annular cutter. The catheter body has a curved portion with a fixed jog section and an adjacent flexible section having a greater flexibility than a remainder of the catheter body. The fixed jog section and the flexible section include a frame having circumferential slits arranged in rows and in a circumferentially offset pattern. The circumferential slits of the flexible section are configured to allow the flexible section to passively bend in multiple directions during positioning of the catheter body within the vessel. The fixed jog section further includes a longitudinal spline having a pre-set curvature. The nosecone is attached to a distal end of the catheter body and includes a cutting window. The annular cutter configured to rotate with respect to the catheter body and positioned within the cutting window.

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 central guidewire lumen, a distal grinding surface, and a fluted portion. The distal grinding surface can be substantially perpendicular to the guidewire lumen and include divots and sharp points that form pyramidal features, where the sharp points extend distally from the distal grinding surface. The fluted portion can have flutes extending around a circumference of the rotatable tip proximal to the distal grinding surface. The fluted portion may not include the divots and sharp points that form the pyramidal features of the distal grinding surface.

Abstract: Methods of performing an atherectomy using an atherectomy catheter. The atherectomy catheter may include a catheter body, a driveshaft, and a distal tip assembly. The driveshaft may include an annular cutting ring with a distal cutting edge. A long axis of the annular cutting ring can be configured to be parallel to a longitudinal axis of the distal tip assembly when the distal tip assembly is deflected with respect to the catheter body. The methods may include advancing the atherectomy catheter within a vessel lumen; axially moving the driveshaft relative to the catheter body to deflect the distal tip assembly with respect to the catheter body and radially extend the distal cutting edge of the annular cutting ring relative to the distal end of the catheter body; driving the distal cutting edge against a wall of the vessel lumen to remove tissue.

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: A catheter for positioning a guidewire across an occluded portion of a vessel includes an elongate catheter body, an integrated rotatable distal tip, a proximal handle region, and a catheter lumen extending through the elongate catheter body. The elongate body has a distal region configured to be bent to a set angle. The integrated rotatable distal tip includes one or more channeled flutes extending around the distal tip that are configured to be rotated in a first direction to dissect tissue and a second direction for bluntly contacting tissue. A proximal handle region includes a control for rotating the distal tip in either the first or second directions. The catheter lumen is configured to pass a guidewire.

Abstract: Versatile tissue collection devices that can provide reduced crossing profiles, fluid pressure release, and/or easy cleaning or removal. In particular, devices having tissue collection devices with multiple configurations to facilitate navigation through narrow vessel cross-sections while also providing adequate tissue storage capacity. Additionally, the devices may include detachable components that allow easy removal, cleaning, and replacement during a procedure. Furthermore, venting elements and sections may be included to relieve fluid buildup in storage reservoirs.

Abstract: A catheter system for optical coherence tomography includes an elongate catheter body, an optical fiber in the elongate catheter body, and an anamorphic lens assembly coupled with a distal end of the optical fiber. The optical fiber and the lens assembly are together configured to provide a common path for optical radiation reflected from a target and from a reference interface between the distal end of the optical fiber and the lens assembly.

Abstract: An atherectomy catheter device includes an elongate body, a drive shaft extending proximally to distally within the elongate body, and a cutter attached to the drive shaft. The cutter includes a serrated annular cutting edge formed on a distal edge of the cutter and a recessed bowl extending radially inwards from the annular cutting edge to a center of the cutter. The recessed bowl has a first curvature. The cutter further includes a plurality of grinding segments extending inwardly from the distal edge within the bowl. Each of the plurality of segments has a second curvature that is different from the first curvature.

Abstract: Described herein is a system and method for identifying elastic lamina during interventional procedures, such as atherectomy. Such identification can be used to avoid trauma to the external elastic lamina during the procedure.

Abstract: An occlusion crossing device includes an outer shaft, an inner shaft, an optical fiber, and a handle attached to the inner shaft and the outer shaft. The inner shaft extends within the outer shaft. The inner shaft includes a drill tip at a distal end thereof. The optical fiber extends within the inner shaft substantially along a central axis of the inner shaft. The distal tip of the optical fiber is attached to the drill tip. The handle is configured to rotate the inner shaft and drill tip at speeds of greater than 500 rpm.

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: An imaging device includes a hollow flexible shaft having a central longitudinal axis and an imaging window therein. An optical fiber extends within the hollow flexible shaft substantially along the central axis. A distal tip of the optical fiber is attached to the hollow flexible shaft and aligned with the imaging window so as to transfer an optical coherence tomography signal through the imaging window. A handle is attached to the hollow flexible shaft configured rotate the hollow flexible shaft at speeds of greater than 1,000 rpm.

Abstract: Described herein are catheters for use with Optical Coherence Tomography (OCT) that include an optical fiber core having a first refractive index and an interface medium having a second refractive index, where the first and second refractive indexes are mismatched such that receiving electronics configured to receive optical radiation reflected from the reference interface and the target operate in a total noise range that is within 5 dB of the shot noise limit. These OCT catheters may include a silicon die mirror having a reflective coating that is embedded in the interface medium. The optical fiber can be fixed at just the distal end of the catheter, and may be managed within a handle that is attached to the proximal end of the catheter body, and is configured to allow rotation of the both catheter body and the optical fiber relative to the handle.

Abstract: A catheter system includes a catheter that includes an outer shaft and a rotatable inner shaft having a drill tip. The catheter can be configured to bend laterally when the inner shaft is rotating within the other shaft for maneuvering within a blood vessel, for example, as the drill tip crosses an occlusion. Catheter bending can be activated by translating the inner shaft relative to the outer shaft in a distal direction, proximal direction, or both. The outer shaft may include a locking feature to rotatably lock the inner shaft with the outer shaft and allowing bidirectional lateral bending of the catheter. The inner shaft can include one or more imaging sensors for collecting images outside of the catheter. The inner shaft may be removable from the outer shaft, for example after an occlusion is crossed, to allow insertion of a guidewire or other device within the outer shaft.