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: 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 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.

Abstract: 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.

Abstract: 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.

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: 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: A catheter system includes a catheter that includes an outer shaft and a rotatable inner shaft having a drill tip body. A distal portion of the outer shaft may include a collar that is configured to releasably engage with the drill tip body so that the collar can rotate with the drill tip. The drill tip body and the collar may include locking features that allow the drill tip body to advance within and rotationally couple with the collar. 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. The catheter may include a flushing feature to flush a distal region of the catheter to improve visibility for an imaging element of the catheter.

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 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: 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 occlusion crossing device that includes an outer shaft having an inner lumen and an inner shaft including a distal end with a drill tip body. There is a projection extending from the inner shaft, in which the inner shaft is removably coupled to the outer shaft so that, in a first configuration, the inner shaft can move axially, and can rotate clockwise or counter-clockwise relative to the inner lumen of the outer shaft, in which, in a second configuration, the projection is configured to engage one or more engagement sites at a distal region of the outer shaft so that the outer shaft and the inner shaft rotate tighter, and further in which in the second configuration, a pulling force on the inner shaft relative to the outer shaft causes the occlusion crossing device to deflect in a first direction, and a pushing force on the inner shaft relative to the outer shaft causes the occlusion crossing device to deflect in a second direction that is opposite the first direction.

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.

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: 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.