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 body, an imaging sensor, a drive motor, a current sensor, a display, and a controller. The catheter body includes a drive shaft. The imaging sensor is fixed relative to the distal end of the driveshaft and is configured to rotate therewith. The drive motor is configured to rotate the drive shaft. The current sensor is configured to measure an amount of current drawn by the drive motor as the drive shaft is rotated. The display is configured to display one or more images obtained by the imaging sensor as the imaging sensor is rotated. The controller is configured to adjust a rotational orientation of the one or more images displayed by the display based upon the measured current.

Abstract: Optical pressure sensor assemblies that can be used with existing catheters and imaging systems. Pressure sensors may be compatible with atherectomy and occlusion-crossing catheters, where intravascular pressure measurements at various vessel locations are needed to determine treatment efficacy. The pressure sensors may employ an optical pressure measurement mechanism using optical interferometry, and may be integrated with existing imaging modalities such as OCT. The pressure sensor assemblies may include a movable membrane that deflects in response to intravascular pressure; an optical fiber that transmits light to the movable membrane and receives light reflected or scattered back from the movable membrane into the fiber; and a processor or controller configured to determine the distance traveled by the light received in the fiber from the movable membrane, where the distance traveled is proportional to the intravascular pressure exerted against the membrane.

Abstract: An atherectomy catheter for use in a vessel includes an elongate catheter body and an annular cutter. The elongate catheter body includes a fixed jog section with a pre-set curvature and a flexible section that has a greater flexibility than a remainder of the elongate catheter body. The fixed jog section and flexible section are formed of a frame including a plurality of circumferential slits therein. Also described herein is an atherectomy catheter for use in a vessel includes an elongate catheter body, an annular cutter, and an s-shaped curved portion in the elongate catheter body. The curved portion includes a frame having a longitudinal proximal spine and a longitudinal distal spine. The longitudinal proximal spine is positioned approximately 180 degrees away from the longitudinal distal spine.

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: 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: 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: 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 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: 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: 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: 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: A catheter system includes a catheter body that includes an outer shaft and a rotatable inner shaft. The inner shaft can include one or more imaging sensors for collecting images outside of the catheter body. The catheter body can include one or more windows for providing imaging access for the imaging sensor(s) outside of the catheter body. A distal portion of the catheter body can include a selective bending feature for bending the distal portion in a defined direction. The catheter body can include one or more markers that the imaging sensor can detect to determine a relative orientation of the catheter body.

Abstract: Optical pressure sensor assemblies that can be used with existing catheters and imaging systems. Pressure sensors may be compatible with atherectomy and occlusion-crossing catheters, where intravascular pressure measurements at various vessel locations are needed to determine treatment efficacy. The pressure sensors may employ an optical pressure measurement mechanism using optical interferometry, and may be integrated with existing imaging modalities such as OCT. The pressure sensor assemblies may include a movable membrane that deflects in response to intravascular pressure; an optical fiber that transmits light to the movable membrane and receives light reflected or scattered back from the movable membrane into the fiber; and a processor or controller configured to determine the distance traveled by the light received in the fiber from the movable membrane, where the distance traveled is proportional to the intravascular pressure exerted against the membrane.

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: 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: 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: 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: 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.