Abstract: Embodiments of the disclosure include apparatuses, systems, and methods for a catheter with a single element for both imaging and interventions. The catheter may have a distal tip which is positionable in a patient (e.g., in a lumen of a vessel). The distal tip may have an optical component which includes both a reflecting surface and a tapered distal end. The reflecting surface may redirect light (e.g., light received along an optical fiber of the catheter) into an imaging beam, which may be directed to a wall of the vessel. The tapered distal end may be a crossing tool used to cross an occluded or partially-occluded section of the vessel. In some embodiments, the reflecting surface and tapered distal end may be the same surface of the optical component. A low refractive index optical filler may be provided to reduce image artifacts at the imaging interface with the patient's fluid and tissue.

Abstract: Described herein are atherectomy catheters, systems and methods of use. The atherectomy catheters may include a driveshaft within an elongate body. An optical fiber may run through the driveshaft and have a distal end that is attached to an opening of a cutter at distal end of the driveshaft. The cutter and the optical fiber may be rotated respect to the elongate body by rotating the driveshaft with respect to the elongate body. The driveshaft may be longitudinally displaced to expose a distal cutting edge of the cutter for cutting tissue or plaque from a vessel lumen. Images of the vessel lumen collected through the opening of the cutter may be captured in real time with the optical fiber.

Abstract: Imaging apparatus, atherectomy devices, systems, and methods of operation thereof are disclosed. The imaging apparatus further comprises one or more light transmittable windows defined along the dividing layer and a catheter outlet port defined along a ventral side of the catheter body. The catheter outlet port allows the guidewire to advance out of the second catheter lumen and the catheter outlet port is aligned with at least one of the light transmittable windows such that the guidewire is within a field of view of the imaging component when the guidewire extends partially though the catheter outlet port. The atherectomy device can comprise a tubular housing and an inflatable balloon coupled to an exterior side of the tubular housing. The tubular housing includes a cutting window and a rotatable cutter configured to debulk the atherosclerotic material extending into the cutting window.

Abstract: An exemplary catheter includes a housing having the distal catheter region configured to be at least partially disposed in a body and the proximal catheter region configured to remain at least partially outside of the body. The catheter may define an imaging lumen configured to receive an imaging device, a guidewire lumen, an off-ramp, and an indicator lumen configured to receive an indicator that is detectable by the imaging device. The guidewire lumen is configured to receive a guidewire and includes a distal region and a proximal region. The off-ramp extends from the guidewire lumen at or near an intersection of the distal and proximal regions of the guidewire lumen. The catheter may also include one or more guidewire feeders configured to cause the guidewire to move from the proximal section to the off-ramp.

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: 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.

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: Described herein are systems and methods 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. Systems and methods may use a catheter having on-board imaging and may be configured to gather optical coherence tomography (OCT) images.

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: Imaging apparatus, atherectomy devices, systems, and methods of operation thereof are disclosed. The imaging apparatus further comprises one or more light transmittable windows defined along the dividing layer and a catheter outlet port defined along a ventral side of the catheter body. The catheter outlet port allows the guidewire to advance out of the second catheter lumen and the catheter outlet port is aligned with at least one of the light transmittable windows such that the guidewire is within a field of view of the imaging component when the guidewire extends partially though the catheter outlet port. The atherectomy device can comprise a tubular housing and an inflatable balloon coupled to an exterior side of the tubular housing. The tubular housing includes a cutting window and a rotatable cutter configured to debulk the atherosclerotic material extending into the cutting window.

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 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 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 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: 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 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.