Atherectomy catheter with serrated cutter

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.

INCORPORATION BY REFERENCE

BACKGROUND

Peripheral artery disease (PAD) and coronary artery disease (CAD) affect millions of people in the United States alone. PAD and CAD are silent, dangerous diseases that can have catastrophic consequences when left untreated. CAD is the leading cause of death in the United States while PAD is the leading cause of amputation in patients over 50 and is responsible for approximately 160,000 amputations in the United States each year.

Coronary artery disease (CAD) and Peripheral artery disease (PAD) are both caused by the progressive narrowing of the blood vessels most often caused by atherosclerosis, the collection of plaque or a fatty substance along the inner lining of the artery wall. Over time, this substance hardens and thickens, which can cause an occlusion in the artery, completely or partially restricting flow through the artery. Blood circulation to the arms, legs, stomach and kidneys brain and heart may be reduced, increasing the risk for stroke and heart disease.

Interventional treatments for CAD and PAD may include endarterectomy and/or atherectomy. Endarterectomy is surgical removal of plaque from the blocked artery to restore or improve blood flow. Endovascular therapies such as atherectomy are typically minimally invasive techniques that open or widen arteries that have become narrowed or blocked.

In certain instances of CAD and PAD, extensive coronary calcification may occur. An increased risk of coronary heart disease is associated with extensive coronary calcification and is a sign of advanced atherosclerosis. Calcified plaque is more difficult to break apart than non-calcified plaque masses. As such, current atherectomy cutters used may not be as effective for breaking down calcified plaques. Thus, it would be advantageous to have a cutter that is better able to attack calcified plaque deposits during an atherectomy procedure.

Atherectomy catheter devices and the corresponding systems and methods that may address some of these concerns are described and illustrated below.

SUMMARY OF THE DISCLOSURE

Described herein are atherectomy catheters and methods of using them.

In general, in one embodiment, 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.

This and other embodiments can include one or more of the following features. Each of the plurality of grinding segments can be a flat facet configured to break calcified and hard fibrous disease in an artery. The second curvature can be larger than the first curvature, or smaller than the first curvature. The plurality of facets can be flat such that the second curvature is zero. The second curvature can be smaller than the first curvature. Each of the plurality of grinding segments can form a convex portion of the serrated annular cutting edge. Each of the plurality of grinding segments can form a concave portion of the serrated annular cutting edge. The serrated annular cutting edge can be angled radially inward relative an outer diameter of the elongate body. The serrated annular cutting edge can extend radially inward relative an outer diameter of the elongate body by 2 degrees to 12 degrees. The plurality of grinding segments can be disposed symmetrically around a circumference of the recessed bowl. The plurality of grinding segments can be disposed asymmetrically around a circumference of the bowl. The recessed bowl can further include a second recessed cavity off-center within the bowl. The bowl can further include a symmetric helical pattern of depressions that can extend from the serrated cutting edge inward towards the center of the cutter. The serrated annular cutting edge can include V-shaped cutouts extending along an outer wall of the cutter. The serrated annular cutting edge can include a plurality of shallow cutouts.

In general, in one embodiment, 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 driveshaft. The cutter includes a serrated annular cutting edge formed on a distal edge of the cutter, the serrated annular cutting edge angled radially inward relative an outer diameter of the elongate body, and a recessed bowl extending radially inwards from the annular cutting edge to a center of the cutter.

This and other embodiments can include one or more of the following features. The cutter can further include a plurality of grinding segments extending inwardly from the distal edge within the bowl. Each of the plurality of grinding segments can have a second curvature that can be different from the first curvature. The plurality of segments can be configured to break calcified and hard fibrous disease in an artery. Each of the plurality of grinding segments can be a flat facet. The second curvature can be smaller than the first curvature. Each of the plurality of grinding segments can form a convex portion of the serrated annular cutting edge. Each of the plurality of grinding segments can form a concave portion of the serrated annular cutting edge. The serrated annular cutting edge can be angled radially inward relative an outer diameter of the elongate body by 2 degrees to 12 degrees.

In general, in one embodiment, 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 driveshaft. The cutter includes a serrated annular cutting edge formed on a distal edge of the cutter. The serrated annular cutting edge includes a plurality of portions. Each of the plurality of portions have a convex shape and a recessed bowl extending radially inwards from the annular cutting edge to a center of the cutter.

This and other embodiments can include one or more of the following features. The cutter can further include a plurality of grinding segments extending inwardly from the distal edge within the bowl. Each of the plurality of grinding segments can have a second curvature that is different from the first curvature. The plurality of grinding segments can be configured to break calcified and hard fibrous disease in an artery. Each of the plurality of grinding segments can form a convex portion of the serrated annular cutting edge. Each of the plurality of grinding segments can be a flat facet. The second curvature can be smaller than the first curvature. The serrated annular cutting edge can be angled radially inward relative an outer diameter of the elongate body. The annular cutting edge can extend radially inward relative an outer diameter of the elongate body by 2 degrees to 12 degrees. The plurality of grinding segments can be disposed symmetrically around a circumference of the recessed bowl. The plurality of grinding segments can be disposed asymmetrically around a circumference of the recessed bowl.

In general, in one embodiment, an atherectomy catheter device includes an elongate body, a hollow distal tip extending from a distal end of the elongate body, a drive shaft extending proximally to distally within the elongate body, and a cutter attached to the driveshaft. The cutter has a serrated annular cutting edge formed on the distal end of the cutter and a recessed bowl extending radially inwards from the cutting edge to the center of the cutter.

This and other embodiments can include one or more of the following features. The bowl may be symmetric. The bowl may further include a second recessed cavity. The second recessed cavity may be positioned off center within the bowl. The second recessed cavity may cover about a third to about half of an area of the bowl. The secondary recessed cavity may include three regions. In this case, the seams delineating the three regions may be raised and form sharp edges. The recessed bowl may further include protruding features that are configured to contact with and grip onto calcified plaque. The serrated cutting edge may further include a series of half-circle scooped cutouts disposed around the perimeter of the serrated cutting edge. The recessed bowl may further include a plurality of off-axis scooped indentations that extend from the serrated cutting edge inward towards the center of the cutter. Intersections between the serrated cutting edge and the plurality of off-axis scooped indentations may form curved cutouts. The plurality of off-axis scooped indentations may further include seams that are raised relative to the rest of the off-axis scooped indentation surface and where the seams may have a sharp edge. The recessed bowl may further include a symmetric helical pattern of depressions that extends from the serrated cutting edge inward towards the center of the cutter, where seams that define the helical pattern can be raised relative to the rest of the symmetric helical pattern surface, and where the seams may have a sharp edge. The serrated annular cutting edge may include V-shaped cutouts that extend along an outer wall of the cutter. The serrated annular cutting edge can include asymmetric V-shaped cutouts that extend along an outer wall of the cutter. The serrated annular cutting edge may also include shallow cutouts disposed along its perimeter that extends along an outer wall of the cutter.

In general, in one embodiment, an atherectomy catheter device includes an elongate body, a hollow distal tip extending from a distal end of the elongate body, a drive shaft extending proximally to distally within the elongate body, and a cutter attached to the driveshaft. The cutter has a smooth annular cutting edge formed on the distal end of the cutter and a recessed bowl extending radially inwards from the cutting edge to a center of the cutter. The recessed bowl includes a series of pockets disposed along the recessed bowl's interior surface.

In general, in one embodiment, an atherectomy catheter device includes an elongate body, a hollow distal tip extending from a distal end of the elongate body, a drive shaft extending proximally to distally within the elongate body, and a cutter attached to the driveshaft. The cutter has a smooth annular cutting edge formed on the distal end of the cutter, a recessed bowl extending radially inwards from the cutting edge to a center of the cutter, and a cutter outer wall having a series of grooves that extend from just beneath the smooth annular cutting edge to the cutter out wall's bottom edge.

In general, in one embodiment, an atherectomy cutter includes a proximal end configured to couple with an atherectomy catheter, a distal end, a cutting edge disposed on the distal end, and a recessed bowl region disposed between the proximal end and the distal end. The cutting edge is disposed on an outer rim of the bowl region and includes a series of half circle cut outs distributed along a perimeter of the cutting edge.

In general, in one embodiment, an atherectomy cutter includes a proximal end configured to couple with an atherectomy catheter, a distal end, a cutting edge disposed on the distal end, and a bowl region disposed between the proximal end and the distal end. The cutting edge is disposed on an outer rim of the bowl region, and the bowl region includes an off-axis second cavity.

In general, in one embodiment, an atherectomy cutter includes a proximal end configured to couple with an atherectomy catheter, a distal end, a cutting edge disposed on the distal end, and a bowl region disposed between the proximal end and the distal end. The cutting edge is disposed on an outer rim of the bowl region, and the bowl region includes a series of off-axes scooped cuts that extend from the cutting edge towards the center of the bowl. An intersection between the cutting edge and each off-axes scooped cut forms an arced cut out.

In general, in one embodiment, an atherectomy cutter includes a proximal end configured to couple with an atherectomy catheter, a distal end, a cutting edge disposed on the distal end, and a bowl region disposed between the proximal end and the distal end. The cutting edge is disposed on an outer rim of the bowl region, and the bowl region includes a series of helically-patterned depressions that extend from an interior of the bowl region to the cutting edge. The cutting edge includes curved cut outs where the helically-patterned depressions intersect the cutting edge.

In general, in one embodiment, an atherectomy catheter includes an elongate body, a hollow distal tip extending from a distal end of the elongate body, a drive shaft extending proximally to distally within the elongate body, and a cutter attached to the driveshaft. The cutter has a recessed bowl extending radially inwards from the cutting edge to a center of the cutter, a cutter outer wall, and a serrated annular cutting edge formed on a distal end of the cutter. The serrated annular cutting edge includes a series of V-shaped grooves that extend from the serrated annular cutting edge and along the cutter outer wall to a proximal end of the cutter.

In general, in one embodiment, an atherectomy catheter includes an elongate body, a hollow distal tip extending from a distal end of the elongate body, a drive shaft extending proximally to distally within the elongate body, and a cutter attached to the driveshaft. The cutter has a recessed bowl extending radially inwards from the cutting edge to a center of the cutter, a cutter outer wall, and a serrated annular cutting edge formed on a distal end of the cutter. The serrated annular cutting edge includes a series of shallow cutouts that extend from the serrated annular cutting edge and along the cutter outer wall to a proximal end of the cutter.

In general, in one embodiment, an atherectomy catheter device includes an elongate body, a hollow distal tip extending from a distal end of the elongate body, a drive shaft extending proximally to distally within the elongate body, and a cutter attached to the driveshaft. The cutter has a recessed bowl extending radially inwards from the cutting edge to a center of the cutter, a cutter outer wall, and a serrated annular cutting edge formed on a distal end of the cutter. The serrated annular cutting edge includes a series of asymmetric V-shaped grooves that extend from the serrated annular cutting edge and along the cutter outer wall to a proximal end of the cutter.

In general, in one embodiment, an atherectomy catheter device includes an elongate body, a drive shaft, and a cutter. The drive shaft extends proximally to distally within the elongate body. The cutter is attached to the driveshaft and includes a serrated annular cutting edge and a recessed bowl. The serrated annular edge is formed on a distal edge of the cutter and includes a plurality of convex portions and each of the plurality of portions has a convex shape. The recessed bowl extends radially inwards from the annular cutting edge to a center of the cutter. This and other embodiments can include one or more of the following features.

The cutter further can include a plurality of grinding segments within the recessed bowl extending from the distal edge and each of the plurality of grinding segments can extend radially inwards relative to neighboring portions. The plurality of grinding segments can be configured to break calcified and hard fibrous disease tissue in an artery.

Each of the plurality of grinding segments can form a convex portion of the plurality of convex portions of the serrated annular cutting edge. Each of the plurality of grinding segments may be a flat facet. Each of the plurality of grinding segments may be a curved facet. Each of the plurality of grinding segments may be configured to extend at least 70% distally to proximally along the recessed bowl. Each of the plurality of grinding segments may be substantially square, rectangular, or trapezoidal in shape. Each of the plurality of grinding segments may form a convex portion of the serrated annular cutting edge.

The serrated annular cutting edge can be angled radially inward relative an outer diameter of the elongate body. The serrated annular cutting edge can extend radially inward relative an outer diameter of the elongate body by 2 degrees to 12 degrees. The serrated annular cutting edge can include a continuous wavy shape.

The plurality of grinding segments can be disposed symmetrically around a circumference of the recessed bowl. The plurality of grinding segments can be disposed asymmetrically around a circumference of the recessed bowl.

In general, in one embodiment, an atherectomy catheter device includes an elongate body, a drive shaft, and a cutter. The drive shaft extends proximally to distally within the elongate body. The cutter is attached to the driveshaft and includes a serrated annular cutting edge add a recessed bowl. The serrated annular cutting edge is formed on a distal edge of the cutter and is angled radially inward relative an outer diameter of the elongate body. The recessed bowl extends radially inwards from the annular cutting edge to a center of the cutter. This and other embodiments can include one or more of the following features.

The cutter further can include a plurality of grinding segments within the recessed bowl extending from the distal edge and each of the plurality of grinding segments can extend radially inwards relative to neighboring portions. The plurality of grinding segments can be configured to break calcified and hard fibrous disease tissue in an artery.

Each of the plurality of grinding segments can form a convex portion of the plurality of convex portions of the serrated annular cutting edge. Each of the plurality of grinding segments can be a flat facet. Each of the plurality of grinding segments can be a curved facet. Each of the plurality of grinding segments can extend at least 70% distally to proximally along the recessed bowl. Each of the plurality of grinding segments can be substantially square, rectangular, or trapezoidal in shape. Each of the plurality of grinding segments can form a convex portion of the serrated annular cutting edge. Each of the neighboring portions can form a concave portion of the serrated annular cutting edge.

The serrated annular cutting edge can be angled radially inward relative an outer diameter of the elongate body by 2 degrees to 12 degrees. The serrated annular cutting edge can include a continuous wavy shape.

The plurality of grinding segments can be disposed symmetrically around a circumference of the recessed bowl. The plurality of grinding segments can be disposed asymmetrically around a circumference of the recessed bowl.

Also described herein are support systems for maintaining medical components, such as controller components of an atherectomy catheter, at a convenient location with easy maneuverability relative to the treatment site.

In general, in one embodiment, a catheter controller support apparatus includes a rail clamp configured to releaseably attach to a rail, a support arm having at least two segments joined by a swivel joint that is configured to couple with the rail clamp through a coupling post, and a catheter controller mount coupled to the support arm and configured to securely maintain a catheter controller.

This and other embodiments may include one or more of the following features. The rail clamp may include a top surface, a support arm coupler disposed on the top surface, a support arm coupling aperture disposed on the support arm coupler, a top jaw, a bottom jaw hinged with the top jaw, a lever for actuating the up and down movement of the top and the bottom jaw, and a support arm securing aperture for locking the support arm in position. The rail clamp may further include a course adjustment knob for increasing and decreasing the distance between the top jaw and the bottom jaw. The rail clamp may further include at least one sleeve bearing contained within the arm coupling aperture. The support arm may further include a first friction knob configured to maintain the swivel joint in a fixed position once the desired position is obtained. The support arm may further include a second swivel joint and a corresponding second friction knob adjacent to the coupling post configured to provide articulated/segmental adjustment of the support arm. The support arm may further include a catheter mount coupler adapted to couple to the catheter controller mount, wherein the catheter mount coupler may further include a mount positioning lever that configured to adjust the angle at which the catheter controller mount is positioned. The support arm may further include at least one cable retainer. The catheter controller mount may further include a catheter controller coupler, wherein the catheter controller coupler may be a post or other protrusion extending from the base of the catheter controller mount that inserts into a corresponding aperture of the catheter controller. The catheter controller mount may further include a controller mount support latch. The catheter controller mount may include a clip having a jaw wide enough to accommodate the catheter controller. The catheter controller mount may include a mount support base, a mount support coupler configured to couple to a catheter controller unit, and a mount support latch for stabilizing the coupled catheter controller unit.

In general, in one embodiment, a catheter controller support apparatus includes a rail clamp configured to releaseably attach to a rail, a support arm coupler disposed on the top surface, a support arm coupling aperture disposed on the support arm coupler, a top jaw, a bottom jaw hinged with the top jaw, a lever for actuating the up and down movement of the top and the bottom jaw, and a support arm securing aperture for locking the support arm in position. The rail clamp includes a top surface. The support arm has at least two segments joined by a swivel joint that is configured to couple with the rail clamp through a coupling post. The at least two segments are coupled by a swivel joint and at least one friction knob maintains the swivel joint in a fixed position once the desired position is obtained. The catheter controller support apparatus further includes a catheter controller mount coupled to the support arm and configured to securely maintain a catheter controller. The catheter controller mount further includes a catheter controller coupler. The catheter controller coupler includes a post or other protrusion extending from the base of the catheter controller mount that inserts into a corresponding aperture of the catheter controller, a mount support base, a mount support coupler able to couple to a catheter controller unit, and a mount support latch configured to stabilize the coupled catheter controller unit.

This and other embodiments may include one or more of the following features. The rail clamp may further include at least one sleeve bearing contained within the arm coupling aperture. The support arm may further include a catheter mount coupler configured to couple to the catheter controller mount, wherein the catheter mount coupler may further include a mount positioning lever that is configured to adjust the angle at which the catheter controller mount is positioned. The support arm may further include at least one cable retainer.

DETAILED DESCRIPTION

The atherectomy catheters described herein can include a cutter. The cutter, for example, can have 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 can include a plurality of segments therein configured to help break up hard plaque or diseased tissue that enters the recessed bowl during use.

The atherectomy catheters described herein can further include a catheter shaft with a drive chassis on the end. The drive chassis includes a stout torque coil (“imaging torqueing coil”/drive shaft) for rotating an imaging element, a cutter, and an imaging optical fiber in the center of the torque coil. Both the imaging elements and the cutter can be part of a head that rotates with the driveshaft. The head can rotate in a single direction (e.g., clockwise). The head can further slide distally/proximally by pushing or pulling the torque coil/drive shaft. As a result of the movement of the driveshaft, a nosecone configured to hold tissue can be displaced. In some embodiments, the nosecone can open and close using an off-axis hinge. In other embodiments, a cam member and cam slot can be used to open and close the nosecone.

FIGS. 1A-3show an example of an atherectomy catheter100including a nosecone that deflects to expose a cutter. The atherectomy catheter100can include a catheter body101having an outer shaft111, a cutter103at a distal end of the catheter body101, and a nosecone105at a distal end of the catheter body101. The nosecone105can further include a cutting window107through which the cutting edge112of the cutter103can be exposed. The nosecone105can be configured to deflect away from the longitudinal axis of the catheter body101about a hinge point1109, as described further below. This deflection can expose the cutter103through the cutting window107and/or radially push the cutter103into a wall of the vessel in which the atherectomy catheter is inserted.

Referring toFIGS. 1A-2C, the cutter103can be positioned between the catheter body101and the nosecone105via a bushing155. In some embodiments, the cutter103can be an annular cutter with a sharp distal edge112. The cutter103can be attached to a drive shaft113configured to rotate the cutter103.

Further, referring still toFIGS. 2A-2B, the atherectomy catheter100can include an imaging element192, such as an OCT imaging element, within the cutter103and proximal to the cutting edge112of the cutter103. The imaging element192can include an optical fiber197that runs substantially on-axis through the center of the elongate body, such as through the driveshaft113, to transmit the OCT signal. Further, the optical fiber197can run straight throughout the catheter body101without bending. The optical fiber197can be attached at the distal end to the cutter103, such as in a slot177in the cutter103. The slot can have a length that extends at least to the center of the cutter103so as to allow the optical fiber197to remain on-axis without a bend through the length of the catheter body101and the cutter103. Aside from the attachment to the cutter103, the optical fiber197can be otherwise be free to float within the catheter body or drive shaft113. In other embodiments, the optical fiber197can be attached to the drive shaft113along the length thereof.

As shown inFIGS. 2A-2C, the imaging element192can include a reflective element199, such as a mirror. The reflective element199can be located within the slot177in the cutter103to radially direct light from the optical fiber197into the adjacent tissue (through the cutter window107). The reflective element199can be oriented at an angle relative to the axis of the optical fiber197, such as at a 35-55 degree angle, e.g. 45 degree angle, to reflect light into the tissue. The distal end of the optical fiber197can be located less than 3 mm from the cutting edge, such as less than 1 mm from the cutting edge, such as less than 0.5 mm. By having the imaging element192close to the cutting edge, the resulting image can advantageously align with the portions of the vessel being cut.

In use, the outer shaft111can be configured to be turned, such as turned manually, to position the cutter window107, cutter103, and/or the imaging element192toward the desired location. The driveshaft113can then be rotated to rotate the cutter103and the imaging elements197. Rotation of the cutter can provide cutting due to the rotational motion of the cutting edge and provide the rotation necessary to image the vessel wall via the imaging element. The drive shaft can be rotated at up to 2,000 rpm, such as approximately 1,000 rpm in a single direction, though rotation in both directions or at higher or lower speeds is possible.

Referring toFIGS. 2A-2C, the drive shaft113can further be configured to translate axially in the proximal and/or distal directions. Such axial movement of the drive shaft113can open and/or close the nosecone105about the hinge point1109(e.g., a pin in the bushing155) to expose or conceal and protect the cutting edge112of the cutter103. For example, the bushing155can include an inner flange170that extends radially inwards. The inner flange170can be positioned distal to the hinge point1109. The bushing155can further include sloped outer distal surface143that angles radially inward from the distal end to the proximal end. Finally, the cutter103can include a proximal edge166and a tapered neck168that gets narrower from the driveshaft113to the head of the cutter103. The interaction of these various elements can open and close the nosecone105.

In one embodiment, proximal retraction of the drive shaft113opens the nosecone105to expose the cutter. For example, as the driveshaft113is pulled proximally, the proximal edge166of the cutter103is forced against the sloped distal surface143of the bushing155. Because the sloped distal surface143angles radially inward from the distal end to the proximal end, the cutter103forces the bushing155, and thus the nosecone105, to deflect away from the longitudinal axis of the catheter body101, thereby opening the nosecone105(see the transition fromFIGS. 2A to 2B and 2B to 2C). The cutting window107can have an opening that is larger than the diameter of the cutter103and cutting edge112to allow the cutter103to protrude out of the nosecone105when the nosecone105is deflected.

In one embodiment, distal movement of the drive shaft113closes the nosecone105. For example, as shown inFIGS. 2A-2C, when the drive shaft113is pushed distally, the tapered neck168of the cutter103will correspondingly move distally. The distal movement of the tapered neck168causes the inner flange170of the bushing155to drag along the widening edges of the tapered neck168, thereby lifting the bushing155, and correspondingly, closing the nosecone105(see the transition fromFIGS. 2C to 2B and 2B to 2A). Because the hinge point is proximal to the inner flange170, a mechanical advantage is achieved that allows for complete closing of the nosecone.

FIGS. 7A-7Dshow close-ups of the bushing155. As shown, the bushing155can include two intersecting channels721,723configured to hold the necked portion168of the imaging subassembly therein when the nosecone is in the open configuration (channel723) and the closed configuration (channel721). Channel721extends through a long distal to proximal axis of the bushing155while channel723extends at an angle relative to channel721and overlaps therewith. The bushing155can further include a hinge channel745formed through a top peripheral region of the bushing155so as to provide the pivot point1109. The hinge channel745can be transverse to the channel721.

Other mechanisms of opening and closing the nosecone are possible. For example, as shown inFIGS. 4A-4D, in one embodiment, a catheter200(having similar features to catheter100except the opening and closing mechanisms) can include a cam slot228in the bushing155that angles toward the cutting window107from the proximal end to the distal end. Further, a cam member290can be attached to the cutter103and configured to extend through the cam slot228. Thus, as the driveshaft113, and thus cam member290, are pushed distally, the cam member290will move within the angled cam slot180. The movement of the cam member290within the angled cam slot180causes the bushing155, and thus the nosecone150, to drop down. Conversely, to close the nosecone, the driveshaft113can be pulled proximally, thereby causing the cam member290to ride within the cam slot228and pull the bushing155back into line with the elongate body101.

Another mechanism of opening and closing a nosecone of an atherectomy catheter400a, bis shown inFIGS. 11A-11B and 12A-12B. The catheter400a, bcan have the same features as catheter100except that the outer distal surface443a,bof the bushing455a,bcan be either normal to the longitudinal axis of the device (such that the angle α is 90 degrees), as shown inFIG. 11Bor slanted radially outward from the distal end to the proximal end (such that the angle α is greater than 90 degrees and the angle with the longitudinal axis is less than 90 degrees), as shown inFIG. 12B. In the embodiment ofFIGS. 12A-12B, an angled space is provided between the proximal edge166of the cutter and the distal surface443bsuch that the only point of contact is an inner radial edge444of the bushing455b. The catheter400awill open and close similarly to as described with respect to catheter100. However, the catheter500bwill open slightly differently in that only the inner-most radial edge444will interact with the proximal edge166of the cutter103, as opposed to the entire surface443, when the driveshaft113is pulled proximally. Such a configuration can advantageously reduce friction while opening the nosecone105. In some embodiments, the proximal edge166can be angled with respect to a longitudinal axis of the catheter; in such cases, the opposing surface443of the bushing455can be either parallel to or angled (acute or obtuse) with respect to the proximal edge166.

As shown inFIG. 3, the atherectomy catheter100(or200or400) can further include a mechanism for packing tissue into the nosecone, such as by moving the drive shaft axially. In one embodiment, movement of the drive shaft113distally closes the nosecone105. Moving the drive shaft113further distally will move the cutter103into a passive position (i.e., against a distal edge of the window107) where the cutter103can be protected by the edge of the window107to avoid undesired cutting of the vessel during use. Moving the drive shaft113further distally will move the cutter103into the nosecone105, thus packing tissue with a distal face of the cutter103, as shown inFIG. 3. The cutter103can move more than 0.5 inches, such as more than 1 inch or more than 2 inches into the nosecone105to pack the tissue. In some embodiments, the nosecone105is formed of a material that is OCT translucent (e.g., non-metallic) so that panoramic OCT images can be taken therethrough.

Referring toFIGS. 14A-14B, in some embodiment a bushing1655can include all of the features of the bushings described above, but can additionally include jet channels1785a,bcut into the inner circumference thereof and extending from the proximal end to the distal end. The jet channels1785a,bcan connect a fluid line within the elongate body101to the nosecone105. Fluid flowing through the jet channels1785a, bcan increase speed and thus provide enough force to pack cut material into the nosecone and clear the imaging region within the nosecone. Further, the jet channels can create a venturi effect at the distal end of the bushing1655, which can suck material into the nosecone and/or away from the imaging/cutting head and/or the distal end region of the elongate body.

In one embodiment, the atherectomy catheter100(or200or400) includes a guidewire lumen in the nosecone105, such as a monorail, for use in guiding the catheter. Advantageously, the guidewire lumen can be used as a marker during imaging.

In some embodiments of atherectomy catheters100,200, or400, there can be one or more small imaging windows207,307in the nosecone105opposite to the cutting window107, as shown inFIGS. 1A and 2A-2C. These additional imaging windows207can provide more of a 180 degree view during imaging. Further, one set of windows207can be more proximal and configured to be axially aligned with the cutter103and the imaging element192when the nosecone is opened while the other set of windows307can be more distal and configured to be axially aligned with the cutter103and the imaging element192when the nosecone is closed and the cutter103is in the passive position. In some embodiments, the imaging windows307,207have different shapes from one another to further help identify cutter position in the resulting OCT images.

Referring toFIGS. 8A-11B, the OCT image catheter with the device will vary depending upon the placement of the imaging device in the three different configurations (nosecone open, nosecone closed with cutter in cutting position, nosecone closed with cutter in packing position). Accordingly, a user can identify, simply by looking at the imaging display, whether the nosecone105is displaced and whether the cutter103is in the cutting or packing position.

For example,FIG. 8Ashows a panoramic image800of a surrounding vessel when the cutter103(and, correspondingly, the imaging sensor) is in the cutting position, as shown inFIG. 8B. The wall of the nosecone105is displayed as the circular feature808in the image800. Further, because the nosecone105is made of a clear material, the vessel tissue806can be imaged even through the nosecone105. As can be seen in image800, a 180 degree view of the tissue806can thus be obtained. The circular artifact803in the image (and here, the radial line801) correspond to a guidewire and/or guidewire channel running alongside the nosecone105.

In contrast to image800,FIG. 9Ashows a panoramic image900of a surrounding vessel when the cutter103is in the passive position and the nosecone105is closed, as shown inFIG. 9B. A 180 degree view of the vessel tissue906is shown on the right side of the image (taken through window107) while the closed nosecone909is shown on the left side of the image (the lines909a,bcorrespond to the bushing wall). The space913between the lines909a,bthrough which tissue906can be seen on the left side of the image is taken through the additional window307in the bushing. Further, the distance between the arrows in image900indicates that the distal tip is “closed” (and close therefore close to the midline of the catheter).

Finally, in contrast to image900,FIG. 10Ashows a panoramic image1000of a surrounding vessel when the cutter103is in the cutting position and the nosecone105is open, as shown inFIG. 10B. The vessel tissue1006(taken through window107) is shown on the right side of the image while the closed nosecone1009is shown on the left side of the image (the lines1009a,bcorrespond to the bushing wall). The space1013between the lines1009a,bthrough which tissue1006can be seen is taken through the window207. A comparison of the relative distance between the arrows inFIGS. 9A and 10Ashows an increased distance between the catheter body and the nosecone, thereby suggesting to the operator that the nosecone105is in an open position. Further, in some embodiments, when the nosecone is open or closed, the image resulting from the window207/307will look different due to the angle change between the windows207/307and the imaging element297and/or the different shape of the windows207/307.

In one embodiment, the atherectomy catheter100(or200or400) includes a flush port close to the cutter103. The flush port can be used to deliver flushing fluid to the region of imaging, thereby improving image quality. In some embodiments, the flushing can be activated through a mechanism on the handle of the device. The fluid can, for example, be flushed in the annular space between the catheter body101and the driveshaft113. Further, in embodiments with jet channels in the bushing, the annular space can connect to the jet channels to provide fluid thereto.

Referring toFIG. 6, in some embodiments, the atherectomy catheters100,200,400can further include two or more balloons configured to help urge the cutter103into the tissue. The first balloon333can be the distal-most balloon. The first balloon333can be positioned proximate to the hinge point1109and opposite to the cutting window1107. The balloon333can urge the cutter103against the tissue by deflecting the cutter103up and into the tissue. A second balloon335, proximal to the distal balloon333, can be on the same side of the catheter100as the cutting window107and can further help drive the cutter103into the tissue by. In some embodiments, the second balloon335can be annular. In some embodiments, the second balloon335can help occlude the vessel. Further, in some embodiments (and as shown inFIG. 6), a third balloon337can be used for occlusion. One or more of the balloons333,335,337can be configured to as to expand with little pressure, such as less than 2 psi. This low pressure advantageously prevents the balloons333,335,337from pushing hard against the vessel wall, but still provides enough pressure to urge the cutter103into the tissue. The balloons333,335,337can further include tapered edges on the proximal and distal edges that allow the balloon to slide along the vessel and/or fit through tortuous regions.

Referring toFIGS. 15 and 16A-16C, in another embodiment, the atherectomy catheters100,200,400can include a single balloon configured to both urge the cutter103into the tissue and occlude blood flow to improve imaging. Referring toFIG. 15, the balloon1733can have a crescent shape, i.e., can be wrapped around the catheter100so as to cover the entire circumference of the catheter100except where the cutter103is exposed. By using a balloon1733with such a shape, the gaps between the catheter100and the vessel1723are substantially reduced, advantageously negating or reducing the localized flushing required to displace blood from the visual field. In one embodiment, to create the crescent shape, the balloon includes wide necks at both ends that are then wrapped around the nosecone105and elongate body101such that they cover at least half of the circumferential surface.FIG. 16Ashows the wrapped balloon edges1735whileFIG. 16Bshows the wide necks1737fused at both ends.FIG. 16Cshows an inflation port1739contained inside the balloon1733as well as a guidewire lumen1741that spans the length of the balloon1733. In some embodiments, the balloon1733can be used to open or close the nosecone without requiring proximal or distal movement of the driveshaft.

Referring toFIG. 5, a handle300can be used to control the rotation or translation of the driveshaft for the catheter100,200, or400. The handle300can advantageously allow the optical fiber to move distally and proximally with the cutter as it is driven without requiring the fiber to move at a proximal location, e.g., without requiring movement of the optical fiber assembly within the drive assembly. Thus, the handle300can be design to completely account for movement of the drive shaft. An exemplary driveshaft management system555is shown inFIG. 5. The driveshaft management system555allows the user to position the driveshaft distally or proximally as the driveshaft is simultaneously spinning at a high speed. In some embodiments, the driveshaft can be configured such that it is fully tensioned before the driveshaft management system555is positioned at its most proximal position. That is, the driveshaft management system555can include a driveshaft tensioning spring556. The spring556can be configured such that, as the user positions the slideable user ring557(or button) proximally, the driveshaft is fully tensioned and the driveshaft management system555is moved proximally, causing the spring556to compress and apply a controlled tensile load on the driveshaft. This fiber management system555advantageously enhances performance of the catheter by tensioning the driveshaft with a pre-determined load to properly position the cutting and imaging component against the bushing at the distal end of the catheter, improving cutting and imaging of the catheter.

The driveshaft management system555can transmit torque originating from a drive assembly, as described further below. Connection to the drive assembly can be made at the optical connector559. Torque can thus be transmitted from the optical connector559, through the fiber cradle551, to the drive key560, through the driveshaft management system555, and then directly to the catheter driveshaft, all of which can rotate in conjunction. The fiber cradle551can include a set of components (i.e., a pair of pieces to make the whole fiber cradle) that houses the proximal end of the optical fiber and transmits torque within the driveshaft system. The fiber cradle components can be thin-walled by design, thereby creating a hollow space inside. Within this hollow space of the fiber cradle551, the optical fiber can be inserted or withdrawn as the device driveshaft is positioned proximally or distally. As the fiber is inserted into the fiber cradle551when the user ring557is positioned proximally, the fiber is able to coil within the internal space of the fiber cradle551while maintaining imaging throughout its length to the distal tip. Conversely, as the fiber is withdrawn from the fiber cradle551when the user ring557is positioned distally, the coiled section of fiber is able to straighten while maintaining imaging throughout its length to the distal tip. This design feature advantageously provides more fiber capacity or “slack” to the overall driveshaft system to increase the range in which the driveshaft system can be translated.

The handle300can further include a balloon inflation chamber552configured to connect to a balloon inflation lumen (e.g., for use with a balloon on the catheter as described above) on one side and to balloon inflation tubing553and/or a port554on the other side. Because the inflation fluid transfers to the balloon through the balloon inflation chamber552, the outer shaft111can advantageously rotate (e.g., by rotating the knob558) independently of the balloon inflation chamber552, allowing the tubing553and/or port554to remain stationary during rotation of the outer shaft111.

Moreover, as shown inFIG. 5, the handle300can further include a catheter flush chamber663and catheter flush tubing664and/or flush port665to provide flushing through the catheter, as described above.

Any of the atherectomy catheters described above can be used with a cutter having a serrated distal edge designed to remove calcified and hard fibrous disease in an artery. The calcified and hard fibrous disease can be difficult to remove due to its increased hardness compared to plaque. While a standard cutter may have no problem debulking the majority of arterial plaque, in certain instances, the plaque encountered by an atherectomy catheter may be harder and/or of a greater volume than what is typically encountered. This may be due to plaque having a larger percentage of calcium, fibrin, and other cellular waste relative to the percentage of fat and cholesterol. A serrated or scalloped cutter with a serrated cutting edge can facilitate cutting and breaking away calcified and fibrous disease. The serrated edge can advantageously initiate the cut into the calcium by utilizing a large force over a small area, thereby providing the greatest cut efficiency to engage and cut the hardened disease.

FIGS. 17A-17Bshow an exemplary atherectomy catheter1700with a serrated cutter1703. The catheter1700includes a catheter body1701and a nosecone1705hinged to the catheter body1701at an off-axis hinge point1709. As in other embodiments, the nosecone1709can be configured to collect tissue therein. In some embodiments, the cutter1703can be moved distally to pack tissue into the nosecone. When the nosecone1705is deflected, the serrated cutting edge1710of the cutter1703can be pushed into the tissue. A balloon1733, when inflated, can also aid in moving the cutting edge1710towards the tissue.

FIGS. 18A-31E and 42A-42Fillustrate various embodiments of serrated cutters that can be used, for example, with atherectomy catheter1700, to break down calcified and hard fibrous disease in the artery. The serrated cutting edge can spin at a high speed with various serrated geometries configured to engage hard calcified and fibrous disease in the diseased arteries.

FIGS. 18A-18Eshow a first variation of a serrated cutter1800designed for removing calcified plaque. AsFIGS. 18A-18Eshow, the serrated cutter1800has a proximal end1802and a distal end1804. The proximal end1802is attachable to drive shaft of an atherectomy catheter. The distal end1804includes a cutting edge1810along the circumference of the serrated cutter1800that includes teeth1812. The teeth1812create saw-like serrations along the edge1810that are configured to cut into calcified tissue. Thus, as the cutter1800is rotated, the teeth1812of the cutting edge1810contribute to better purchase and grabbing of calcified deposits for breakage and/or removal of the deposits.FIG. 18Eshows the cross-sectional side view of the cutter1800attached to a driveshaft1813.

The serrated cutter1800also includes a symmetric and concave or recessed bowl1814extending radially inwards from the cutting edge1810to the central axis of the cutter1800. Further contained within the bowl region is an asymmetric cavity1816(i.e., extending off of a central axis of the cutter1800). The asymmetric cavity1816covers between ⅓ and ½ of the surface area of the bowl region1814of cutter1800. The asymmetric cavity1816, as shown inFIG. 18D, includes three regions that further aid with breaking up of the harder forms of plaque. Further, seams1815delineate the three regions of the asymmetric cavity1816may protrude slightly above the surface of the asymmetric cavity1816walls, where the seams1815may be sharp or may include grabbing features that further aid with gripping onto and breaking apart calcified plaque deposits. It is also conceivable that the asymmetric cavity includes greater or less than three regions. As the cutter1800is rotated, the asymmetric cavity1816advantageously breaks up the calcium plaque within the bowl1814as the off-axis sidewalls and/or seams hit the rigid pieces within the bowl1814, advantageously avoiding having the calcified plaque fold back onto itself (which can cause stalling of the cutter).

Each tooth1812of the cutter1800borders a grinding segment1818. The grinding segments1818are depressions or scoops in the bowl1814that have a greater curvature than the bowl1814. The grinding segments1818have a concave curvature at the distal end1804of the cutter1800(as seen inFIGS. 18C and 18E). The grinding segments1818of the serrated cutter1800are largely semi-circular in shape and disposed equidistantly about the perimeter of cutter1800. The grinding segments1818can have sharp edges or points therearound that are configured to grind, sever, and/or grab onto the calcified plaque by applying more pinpointed force to the calcified plaque encountered while the cutter is rotating. In other variations, the grinding segments1818disposed about the circumference of cutter1800may be otherwise shaped (e.g. square or rectangular cut outs, triangular cut outs, symmetric, asymmetric, and so forth). Further, the grinding segments1818can be either equidistantly disposed about the cutter perimeter or can be more unevenly or non-uniformly disposed about the cutter perimeter.

FIGS. 19A-19Eshows drawing of a second variation of a serrated cutter1900designed for removing calcified plaque deposits. The serrated cutter1900shown inFIGS. 19A-19Epossess many of the same features as the cutter1800shown inFIGS. 18A-18D, such as a serrated cutting edge1910having teeth1912and half-circular grinding segment1918sdisposed evenly along the circumference of the cutting edge1910. Similar to the design shown inFIGS. 18A-18E, the grinding segments1918can be depressions within the bowl1914that are disposed along the perimeter of the cutter1910. The grinding segments1918can aid with grabbing and grinding into calcified plaque as the cutter rotates and are able to impart targeted force on the calcified plaque encountered and more easily break off the harder plaque formations. The bowl1914is symmetric and recessed in essentially in the shape of a half sphere for accommodating larger plaque formations. In some variations, the bowl region1914may also include additional features that can further aid with grabbing and breaking apart calcified plaque as the cutter rotates. Additional features may include protrusions, or cavities about its sidewalls that are either symmetrically or asymmetrically distributed along the wall. The protrusions may have a sharp edge or point while the cavity may have a sharp edge, where these features aid with gaining purchase of the calcified plaque during the procedure. There may also be features at the base of the bowl that aid with gripping and purchase while the serrated cutter is rotating.

Another variation of a serrated cutter2000for easier debulking of calcified plaque is shown inFIGS. 20A-20E. The serrated cutter2000includes a bowl region2014having a serrated cutting edge2010disposed along its perimeter. The cutting edge2010includes a plurality of teeth2012extending therearound with a plurality of grinding segments2018therebetween. The grinding segments2018can form a deeper scooped portion along the serrated edge2010. The grinding segments1218can extend radially inwards towards and past the center of the bowl2014in an off-axis or spiraled manner. While the scooped grinding segments2018are shown inFIG. 20Din a symmetric pattern, as the cutter2000rotates, the scooped regions2018creates rotational asymmetry within the bowl region2014that allows the walls of the grinding segments2018to grab onto the plaque and scoop the plaque out and break the plaque up. The combination of the teeth2012and the off-axis scoop cuts of the grinding segments2018provide enhanced cutting and grinding of calcified plaque as the cutter2000rotates. The teeth2012and/or grinding segments2018may further include edges or seams2016that are raised with respect to the surface of the scooped regions2018to further aid with gripping the calcified plaque during use. Furthermore, the bowl2014and/or the off-axis scooped regions may also include other gripping texture or features that are able to further enhance the purchase of the cutter on plaque deposits encountered during use of the cutter.

FIGS. 21A-21Eshow another variation of a serrated cutter2100that is well-suited for debulking calcified plaque. Serrated cutter2100also includes a serrated cutting edge2110along the circumference of cutter2100. Serrated cutter2100also includes a bowl region2114. Cutter2100further includes a series of teeth2112and a series of scooped out grinding regions2118that each begin at the cutting edge2114and extend inward towards the center of the bowl region2114. The edge of the scooped out region2118correspond to concave portions along the perimeter of the cutting edge2110. As the cutter rotates, the teeth2112and the scooped grinding segments2118aid greatly with gaining purchase of the calcified regions and providing targeted force onto the calcified plaque. In this example, the series of scooped grinding segments2118are arranged in a helical patter within bowl region2114. The helical cutting pattern2118can advantageous help grab onto plaque and cut the plaque when the cutter is rotating. Cutter2100may also include additional features2116within the bowl2114that increase the cutter's gripping ability while in use.

FIGS. 22A and 22Bshow a cutter2200having no serration along the outer circumference. The cutter2200, similar to the other cutters already described, includes a bowl region2214. The cutter2200has a cutting edge2210along its outer perimeter. The cutting edge2210is smooth and continuous. Rather than having serrations, cutter2200has a series of breaker pockets or grinding segments2218distributed along an inner circumference of the bowl region2214. Each grinding segment2218includes a cavity (having a greater curvature than the bowl2214) for aiding in gripping onto hardened plaque and serve to break up and debulk calcified plaque encountered. The grinding segments2218can be in the shape of a circle or an oval. The intersection between the grinding segments2218and the areas of the bowl regions2214may possess sharpened edges that further aid with gripping and breaking up of hardened plaque. As the cutter2200rotates, the grinding segments2218can aid with further crushing of the plaque formations and sending these broken down plaque into the nosecone region. While the grinding segments shown inFIGS. 22A and 22Bare symmetric and evenly distributed within the bowl region, in some embodiments, the breaker pockets may be asymmetric in shape and may not all be of the same size.

In some instances, hydraulic pressure may be present due to the tight fit between the major, outer diameter of the cutter and the inner diameter of the catheter's nosecone. Turning toFIGS. 23A and 23B, cutter2300includes features that may be able to alleviate some or all of the hydraulic pressure. Like many of the cutters previously discussed, the cutter2300includes a bowl region2314and a serrated cutting edge2310disposed therearound. Here, the teeth2312are separated by V-shaped grooves2323distributed around the perimeter of the bowl region2314. Further, the V-shaped grooves2323of cutter2300may extend along an outer wall2320of cutter2300such that where the V-shaped grooves2318occur, corresponding V-shaped channels2319extend from the V-shaped groove2323along the entire length of cutter2300's outer wall. The V-shaped channels2319spaced around the outer wall of cutter2300serve to relieve any hydraulic pressure that may be generated in the nose cone when the cutter is slid forward deeper into the nosecone and subsequently when the cutter is drawn back during rotation of the cutter.

Turning toFIGS. 24A and 24B, a cutter2400is shown. The cutter2400includes a bowl region2414and a serrated cutting edge2410disposed along the perimeter of the bowl region2414. The serrated cutting edge2410includes a plurality of teeth2412separated by shallow cutouts2423in the cutting edge2410. In this variation of the cutter, the shallow cutouts2423extend along an outer wall2420of the cutter2400to form a rounded channels2419that are disposed on the outer wall2420of the cutter2400. The rounded channels2419, similar to the V-shaped channels2319described earlier, can serve to relieve hydraulic pressure that may build up while the rotating cutter is pushed into the nosecone of the catheter.

FIGS. 25A and 25Bshows a cutter2500, another variation of cutter designs that include grooves along the outer wall of the cutter. Here, the cutter2500includes a bowl region2514and a serrated cutting edge2510disposed along the perimeter of the bowl region2514. The cutting edge2510is formed by teeth2510separated by v-shaped recesses2512. The v-shaped recesses2523are asymmetric such that the channels2519that are formed from the asymmetric recessed regions2512and that extend along an outer wall2520of the cutter2500are also asymmetric in nature. An advantage of having asymmetric grooves disposed along the outer wall of the cutter is that there is less likelihood that the groove edges from catching on the inner diameter of the nosecone as the cutter is rotating.

Another variation of a cutter2600is shown inFIGS. 26A and 26B. The cutter2600includes a bowl region2614and a cutting edge2610disposed along the perimeter of the bowl region2614. Here, the cutting edge2610has a smooth cutting surface about the outer perimeter of the bowl region2614. The cutter2600further includes angled channels2619disposed around the outer wall2620of the cutter2600. The angled channels2619preserves the smooth cutting edge2610by originating on the outer wall2620of the cutter2600just below the cutting edge2610and extending away from the smooth cutting edge2610. The cutter2600may be used in scenarios where the plaque encountered are not of the hardened and calcified variety and where a smooth cutting edge can successfully debulk the plaque encountered. The grooves arranged around the outer wall2620are able to minimize the buildup of hydraulic pressure when the cutter is pushed and subsequently pulled back from the catheter nosecone.

FIGS. 27A-27Eillustrate another exemplary embodiment of a serrated cutter2700having a serrated annular cutting edge2710, a recessed bowl2714, and a plurality of grinding segments2718. The cutter2700can include the recessed bowl2714extending radially inwards from the annular cutting edge2710to a center of the cutter2700. The recessed bowl2714can extend radially inwards from the cutting edge2710with a converge angle. For example, the converge angle of the recessed bowl can be 90 degrees, as shown inFIG. 27E.

The cutter2700can further include a plurality of grinding segments2718or dimples within the bowl2714and extending radially inwardly from the cutting edge2710. The plurality of segments2718can each have a substantially circular or ovoid shape. In some other embodiments, the plurality of segments2718may be otherwise shaped. Further, each of the plurality of segments2718can have a curvature that less than the curvature of the bowl2714. As shown inFIGS. 27A-27D, each of the plurality of grinding segments2718can be a flat facet (i.e., such that the curvature is zero and the radius of curvature is infinite). The plurality of grinding segments2718can advantageously break the uniformity of the recessed bowl2714, thus facilitating breaking hard substances such as calcium. The number of segments can be 2, 3, 4, 5, 6, 8, 12 or any number therebetween. For example, the cutter2700can have six grinding segments2718as shown inFIGS. 27A-27E. Further, the plurality of grinding segments2718can be either equidistantly disposed about the cutter perimeter or can be more unevenly or non-uniformly disposed about the cutter perimeter. The plurality of segments2718can be disposed symmetrically or unsymmetrically around the circumference of the cutting edge2710.

As shown inFIGS. 27A-27E, each of the plurality of segments2718can form a convex tooth2712of the serrated annular cutting edge2710. The convex teeth2712can be a portion of a circular shape or elliptical shape or other convex shape. The convex shaped teeth2712can be advantageous because there no sharp points are formed along a distal-most circumference of the cutting edge2710. Since there is a constant force being applied along the arc from cutting tissues, the convex shaped portions are gentle in contact with tissue and have a long cutting length, thus engaging again tissue for a long time. The plurality of convex teeth2712can be configured to grind and grab onto the calcified plaque by applying pinpointed force to the calcified plaque encountered while the cutter is rotating.

As shown inFIG. 27CandFIG. 27E, the serrated annular cutting edge2710can angled radially inward relative an outer-most circumference of the cutter2710(and/or relative to the elongate body of the catheter to which it is attached). The outer side wall of the cutter edge2710on the distal tip2704can an angle α relative to a sidewall of the outermost circumference of the cutter2700(or of the attached catheter body) along a longitudinal direction. The angle α is advantageous such that the cutting edge2710does not cut through the nosecone itself. The angle α can be between 2 to 12 degrees in some embodiments. For example, the angle α can be 5 degrees. The distal tip2704of the serrated annular cutting edge2710can extend radially inward relative an outer diameter of the elongate body by 2 degrees to 12 degrees. The serrated annular cutting edge2710can angled radially and converged to a center axis of the cutter2700with a converge angle between 4 degrees and 20 degrees. For example, the converge angle can be 10 degrees in some embodiments as shown inFIG. 27E.

FIGS. 42A-42Fshow another exemplary embodiment of a serrated cutter82700designed for removing calcified plaque. Similar to the cutter2700, serrated cutter82700has a proximal end82702configured to attach to a drive shaft of an atherectomy catheter and a distal end82704, a serrated annular cutting edge82710along the circumference of the distal end82704, a recessed bowl82714, and a plurality of grinding segments82718.

The cutter recessed bowl82714can extend radially inwards from the annular cutting edge82710to a center of the cutter82700at a converge angle α (seeFIG. 42E). For example, the converge angle α of the recessed bowl can be between 80 and 100 degrees, such as 90 degrees.

The grinding segments82718can be positioned within the bowl82714and extend radially inwardly from the cutting edge82710. The grinding segments82718can extend radially inwards relative to neighboring portions82719so as to form segments that break apart rigid pieces of tissue or plaque as the cutter82700spins. The segments82718can each have a least one inner edge82728that extends substantially straight from the cutting edge82710to the center of the cutter82700. Thus, the segments82718can be squared, rectangular, or trapezoidal. The portions82719between the segments82718and radially outwards thereof can be, for example, triangular in shape. The plurality of segments82718can have the same shape as one another or can have different shapes (e.g., some rectangular and others trapezoidal). Further, the plurality of segments82718can extend distally to proximally part or all of the way along the recessed bowl82714. For example, the plurality of segments can extend at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, or substantially 100% distally to proximally along the bowl82714between annular cutting edge82710and the recessed flat section82727. Each of the plurality of grinding segments82718can be a flat facet (i.e., such that the curvature is zero and the radius of curvature is infinite) or can have a curvature (have a “scooped out” configuration). Further, each of the plurality of segments82718can have a curvature that is less than the curvature of the bowl82714. The plurality of grinding segments82718can advantageously break the uniformity of the recessed bowl82714, thus facilitating breaking hard substances such as calcium. The bowl82714can have 2-16 grinding segments82718therein, such as 2, 3, 4, 5, 6, 8, or 12 grinding segments82718. For example, the cutter82700can have six grinding segments82718as shown inFIG. 42D. Having fewer grinding segments may, for example, make the recessed bowl easier to manufacture while having more may better distribute the load as the cutter rotates and cuts material. Further, the plurality of grinding segments82718can be either equidistantly disposed about the cutter perimeter or can be more unevenly or non-uniformly disposed about the cutter perimeter. The plurality of segments82718can be disposed symmetrically or unsymmetrically around the circumference of the cutting edge82710.

As shown inFIGS. 42A-42F, each of the plurality of segments82718can form a convex tooth82712of the serrated annular cutting edge82710while the neighboring portions82719therebetween can form a concave section82721therebetween. The convex teeth82712can be a portion of a circular shape or elliptical shape or other convex shape. The convex teeth82712and concave section82721can form an undulated or wavy cutting edge82710(e.g., by a continuous wave of scallops). The undulating cutting edge82710can be advantageous because there are no sharp points along a distal-most circumference of the cutting edge82710, thereby allowing the edge82710to last longer without wearing down. Additionally, the entire undulating cutting edge82710can contact tissue as the cutter82700is rotated, thereby providing sharper cutting through the tissue or plaque. The proximal edge82723formed by the segments82718and neighboring portions can have a similar undulating shape.

The plurality of convex teeth82712and grinding segments82718can be configured to grind and grab onto the calcified plaque by applying pinpointed force to the calcified plaque encountered while the cutter is rotating.

As shown inFIG. 42F, the serrated annular cutting edge82710can be angled radially inward relative an outer-most circumference of the cutter82710(and/or relative to the elongate body of the catheter to which it is attached). The outer side wall of the cutter edge82710on the distal tip82704can extend inwards at an angle β relative to a sidewall of the outermost circumference of the cutter82700(or of the attached catheter body) along a longitudinal direction. The angle β is advantageous such that the cutting edge82710does not cut through the distal end of the catheter (e.g., the nosecone). The angle β can be between 2 to 12 degrees in some embodiments. For example, the angle β can be 5 degrees.

The recessed bowl82714can further including a flat (i.e., not curved) circular section82727at the proximal end of the recessed bowl thereof that is recessed relative to the proximal undulating edge82723formed by the grinding segments82718and neighboring portions2719.

FIG. 28A-28Eillustrate another embodiment of a serrated cutter2800having a serrated annular cutting edge2810, a recessed bowl2814, and a plurality of grinding segments2818. The serrated annular cutting edge2810can have a plurality of teeth2812. As shown inFIGS. 28A-28E, each of the plurality of segments2818can form concave edges between the teeth2812of the serrated annular cutting edge2810. The curvature of the grinding segments1818can be greater than the curvature of the bowl2814, thereby forming depressions or cavities in the bowl2814. The number of segments can be 2, 3, 4, 5, 6, 8, 12 or any numbers therebetween. For example, the cutter2800can have seven recessed grinding segments2818as shown inFIGS. 28A-28E. Further, the plurality of grinding segments2818can be either equidistantly disposed about the cutter perimeter, as shown, or can be more unevenly or non-uniformly disposed about the cutter perimeter. The plurality of segments2818can be disposed symmetrically, as shown, or unsymmetrically around the circumference of the cutting edge2810.

As shown inFIG. 28C, the serrated annular cutting edge2810can be angled radially inward relative an outer diameter of the cutter2800(and/or the elongate body of the catheter). The outer side wall of the cutter edge2810forms an angle β relative to a sidewall of the elongate body of the catheter2800along a longitudinal direction. The angle β can be between 2 to 12 degrees in some embodiments. For example, the angle β can be 5 degrees. The distal tip of the serrated annular cutting edge2810can extend radially inward relative an outer diameter of the elongate body by 2 degrees to 12 degrees. The angle β advantageously ensures that the cutting edge2810does not cut through the distal tip or nosecone of the catheter. The serrated annular cutting edge2810can be angled radially and converged to a center axis of the cutter2800with a converge angle between 4 degrees and 20 degrees. For example, the converge angle can be 10 degrees in some embodiments as shown inFIG. 28E.

FIGS. 29A-29Eillustrate a cutter2900including a serrated annular cutting edge2910with teeth2912and a recessed bowl2914. The atherectomy cutter2900can be similar to the cutter2800except that the cutter can include five grinding segments2918rather than seven. Further, each of the segments2918can be longer, e.g., extend a greater distance along the circumference of the cutting edge2910, than in cutter2800.

FIGS. 30A-30Eillustrate a cutter3000including a serrated annular cutting edge3010with teeth3012and a recessed bowl3014. The cutter3000can be similar to cutters2800and2900except that the cutter can include ten grinding segments3018. The grinding segments3018can form a substantially half-circle shape.

FIGS. 31A-31Eillustrate a cutter3100. The cutter3100can be similar to cutter3000except that the grinding segments3118can be further closer to one another, thereby making the teeth3112shorter. For example, the cutting edge of each tooth3112of cutter3100can be approximately 0.1-0.3, such as approximately 0.25, of the length of cutting edge of each grinding segment3118. In contrast, the cutting edge of each tooth3012can be approximately 0.4-0.6, such as 0.5 of the length of the cutting edge of each grinding segment3018. In some embodiments, the cutter3100can also be smaller in size overall (e.g., be configured to sit within a 7 French catheter) than the cutter3000(which can be configured, for example, to sit within an 8 French catheter).

The cutters described herein can be used, for example, for above the knee atherectomy procedures. In such embodiments, the cutter can be designed to fit in an 8 French catheter and thus can have a diameter, for example, of between 0.07 inches and 0.9 inches, such as approximately 0.077 inches. The cutters described herein can also be used, for example, for below the knee atherectomy procedures. In such embodiments, the cutter can be designed to fit in a 7 French catheter and can have a diameter, for example, of between 0.05 inches and 0.07 inches, such as approximately 0.065 inches. The recessed bowl in the cutters described herein can advantageously help collect and push cut tissue or plaque into the collection chamber in the nosecone of the atherectomy device.

The cutters described can be useful for gripping on to and breaking apart calcified plaque deposits found within the arteries as well as softer forms of plaque that may be encountered. Because calcified plaque is much harder than its softer plaque counterparts, repeated use of the cutter for breakoff and clearing calcified plaque can easily lead to dull cutting edges that are less proficient at grabbing onto and breaking off calcified plaque during subsequent use. Thus, in some examples of the serrated cutter, the cutting edge or even the entire cutter region, including the cutting edge and the bowl, may be coated with or dipped in a hardening material. Suitable hardening coatings may include carbon composites such as tungsten carbide, graphene, and so forth. While the cutters described herein are shown with specific features, it is conceivable that different features from the different cutters described may be combined to form cutters having feature combinations that have not been specifically described herein.

In some embodiments, the cutters serrated cutters described herein can be configured to be interchangeable with one another and/or with non-serrated cutter so as to allow the operator to vary the aggressiveness of the cutter during use.

It should be understood that any feature of one embodiment of a cutter described herein can be added, removed, and/or combined with other embodiments.

Advantageously, the atherectomy catheters described herein can be used to remove strips of tissue and/or to remove hard or calcified tissue.FIG. 13Ashows the removal of a single, long strip of material cut from the tissue by an atherectomy catheter as described herein.FIGS. 13B and 13Cshow the length of tissue (weighting 70.4 mg) removed.

The atherectomy catheters described herein may additionally include any of the features described in the following co-pending applications: PCT Application No. PCT/US2013/031901, entitled “ATHERECTOMY CATHERES WITH IMAGING,” and filed Mar. 15, 2013, and PCT Application No. PCT/US2013/032494, entitled “BALLOON ATHERECTOMY CATHERS WITH IMAGING” and filed Mar. 15, 2013, and PCT Application No. PCT/US17/22780, entitled “ATHERECTOMY CATHETERS AND OCCLUSION CROSSING DEVICES” and filed Mar. 16, 2017, all of which are incorporated by reference herein in their entireties.

The catheters described herein can be driven using a drive assembly. Exemplary drive assemblies are described in co-pending patent applications: PCT Application No. PCT/US13/32089, entitled “ATHERECTOMY CATHETER DRIVE ASSEMBLIES,” filed Mar. 15, 2013, and U.S. patent application Ser. No. 13/654,357, titled “ATHERECTOMY CATHETERS AND NON-CONTACT ACTUATION MECHANISM FOR CATHETERS,” filed Oct. 17, 2012, both of which are incorporated by reference in their entireties.

Also described herein are support arms for maintaining and positioning a medical device component, such as a controller or drive assembly of an atherectomy catheter, during related medical procedures. In particular, the support arm is able to attach easily to any rail in close proximity to the procedure table and to take multiple positions for providing convenient access to a catheter (e.g., atherectomy catheter) control unit.

An exemplary support arm assembly9100is shown inFIGS. 32A-32C. In general, the support arm assembly9100can include a clamp9110, a support arm9130and a device mount9150. In some embodiments, the assembly9100can also include a cable retainer9170. The support arm9130has two ends. The clamp9110couples to one end of the support arm9130, and the device mount9150couples to the other end.

The support arm9130may be releaseably attached to clamp9110. Support arm9130may swivel up to 9360 degrees with respect to clamp9110. This allows the support arm9130to be easily positioned anywhere along the length of an operating or procedure table. The support arm9130may also be adjusted so that it can reach the width of any operating or procedure table. In use, the free end of the support arm9130is coupled to the device mount9150. The free end of the support arm9130can allow for rotational freedom of the coupled device mount9150such that the device component being held by the device mount9150may be arranged in the most optimal position during a procedure.

As shown inFIG. 32B, the support arm9130can include two segments9134and9139joined by a segment joint9135. WhileFIG. 32Bshows segments9134and9139as being cuboid in shape, the segments can be any reasonable geometric shape, such as hexagonal or triangular prism, a cylindrical rod, and so forth. As shown inFIGS. 32A-32C, the segment joint9135provides a hinged connection between segment9134and segment9139. The segment joint9135, as shown, provides freedom to move along one axis. In other examples, the segment joint may be a joint that provides greater degrees of freedom such that one segment is able to rotate out of axis relative to the second segment.

Each segment9134and9139can include segment free ends9137and9138. At segment free end9137is a clamp arm joint9132. A clamp arm joint9132couples with the segment free end9137of segment9134. Disposed on the clamp arm joint9132is a clamp coupling post9131for coupling to clamp9110. In the figures, the clamp arm joint9132that joins clamp coupling post9131with segment9134is a hinged connection that allows for movement of the segment9134relative to the clamp coupling post9131in a fixed axis of rotation. In other examples, the coupling joint that connects one segment to the clamp coupling post may be a rotatable joint that is able to have multiple degrees of rotational freedom.

Disposed at the segment free end9138can be a device mount coupler9142that couples the segment9139to the device mount9150. The device mount coupler9142shown inFIG. 32Bis configured to rotate along one axis, but in other examples, the device mount coupler9142may rotate along multiple axes. The device mount coupler9142also includes a device mount adjustor9143. The device mount adjustor9143is able to loosen or tighten the device mount coupler9142for positioning the device mount9150and maintaining the device mount9150once a desired position has been found.

The support arm9130can also include friction adjustors9133and9136. In some embodiments, the friction adjustors9133and9136can be identical. An exemplary embodiment of a friction adjustor9233(which can be used as a friction adjustor9133and/or9136) is shown inFIGS. 33A-33B. The friction adjustor9233can each include an adjustment knob screw9140and an adjustment knob handle9141. The adjustment knob handle9141is shown as having a rod-like structure of approximately 3.5 inches in length, but in other examples, the adjustment knob handle may be of either shorter or longer length and may be of other suitable shape such as a flat piece of material or a rod having various cross-sectional dimensions. The adjustment knob screw9140includes a screw portion9144at one end and a handle coupler9145at its opposing end joined by an adjustment knob screw stem9146. The handle coupler9145as shown further includes a handle coupling aperture9148into which the adjustment knob handle9141may be inserted. While the figures show the adjustment knob handle9141as having a circular cross-section and the handle coupler aperture9148having a corresponding circular opening, it is possible for the adjustment knob handle to have any cross-sectional dimension and for the handle coupling aperture to have a corresponding aperture opening shape to accommodate the adjustment knob handle. In use, once the operator has positioned the support arm9130into a desired position, the operator may turn the adjustment knob handle9141such that the screw portion9144bears down on either the segment joint9135or the clamp arm joint9132, locking the segments into a fixed position. The adjustment knob handle9141may be turned to loosen and reduce the amount of force that the screw portion9144of the adjustment knob screw9140applies to either the segment joint9135or the clamp arm joint9132.

WhileFIGS. 32A-32Cshow the support arm segments as having approximately equal length, the segments may of differing length. In other examples, the support arm may include more than two segments or include many segments such that the medical device component may be more easily maneuvered or maneuvered with greater precision. In yet other examples, the support arm segments may have telescoping qualities such that each segment may be lengthened or shortened depending on the position desired.

Moreover, whileFIGS. 32A-32Cshow a knob type adjustment for adjusting and maintaining the support arm segments, other types of adjustment units may also be used. These may include a flip type locking mechanism, a ratchetting system, or other type locking mechanism known in the art that is integrated into the body of the coupled segments.

Referring still toFIGS. 32A-32C, the clamp9110can be configured to couple the assembly9100to a bed rail or other solid support. The clamp9110can thus be configured to provide enough support and stability to hold both the support arm9130and a medical component coupled to the device mount9150steady during a procedure. As such, the clamp9110can be designed so as to withstand the weight of the support arm9130, the device mount9150, and the medical device within the mount9150even as the arm9130is maneuvered around. In some embodiments, the clamp9110securely attaches to a rail or other solid support when the medical device within the mount9150is greater than 5 pounds, greater than 10 pounds, or greater than 15 pounds, such as up to approximately 20 pounds. The clamp9110can be easy to adjust such that, with a single motion, a user is able to attach or release the clamp9110from a rail or a solid surface or support. In some embodiments, the clamp9110has an adjustable diameter of between 0.5 inch and 3 inches.

As shown inFIGS. 32A and 32B, the clamp9110can be coupled to the support arm9130through the clamp coupling post9131. An exemplary embodiment of a clamp9310(which can be used as claim9110) is shown inFIGS. 34A-34E. The clamp9310includes a clamp top jaw9114, a clamp top cover9111, a clamp bottom jaw9120, and a clamp lever9116. The jaws9114,9120can be configured to move towards one another to clamp a device therebetween. The clamp top cover9111can include a support arm coupler9112and a cutout region9117, both of which are disposed on the top surface of the clamp top cover9111. The support arm coupler9112can further include a support arm coupling aperture9113that may be mated with the clamp coupling post9131. The support arm coupler9112may also include sleeve bearings9119to provide better rotational movement by reducing friction between the clamp coupling post9131and the support arm coupler9112. There may also be screws9333for retaining the sleeve bearings9119in place. The cutout region9117can be positioned opposite the support arm coupler9112. The top piece cutout region9117can function to retain a course adjustment knob9118.

In use, the distance between the clamp upper jaw9114and the clamp lower jaw9120may be adjusted to retain various sizes of rail or surface. Distances between the upper jaw9114and the lower jaw9120may range from 0.5-3 inches. In some embodiments, the operator may turn the course adjustment knob9118when it is coupled to the clamp9110to adjust the initial distance between the top jaw9114and the bottom jaw9120.

In some embodiments, a lever9116can be configured to allow for vertical movement of the clamp lower jaw9120. The lever9116includes a lever handle9123and a lever stem9124. By toggling the lever handle9123from one side to another and back, the operator may adjust the distance between the clamp upper jaw9114and the clamp lower jaw9120. The lever9116is in a shape that allows easy adjustment of the distance between the upper and lower jaws9114,9120of the clamp9110. The lever9116includes a lever stem9124that mates with a side cam lever adjustor9122. The lever9116also includes a lever stem cutout9125that may be used to retain a post or dowel9127that allows for coupling to the side cam lever adjustor9122. The side cam lever adjustor9122includes a side cam lever adjustor aperture9126that couples to lever stem9124. Furthermore the side cam lever adjustor aperture9126may further include a side cam lever adjustor aperture cutout9128that serves to more precisely mate with the lever stem cutout9125of lever9116through the dowel9127such that when the lever handle9123of lever9116is moved from one side to the other, the dowel9127is moved within the side cam lever adjustor aperture cutout9128and through the clamp bottom piece aperture9121to move the bottom jaw piece9115up and down. The side cam lever adjustor9122may also include side cam lever adjustor coupling apertures9129for coupling to the upper jaw9114and the lower jaw9120pieces. The joining of the lever9116with the bottom jaw piece9115through the side cam lever adjustor9122may also include washers for cushioning the movement of the lever with respect to the side cam lever adjustor. The claim9310may also include a spring9331to provide a more even force distribution against the bottom jaw piece9115when actuated by the side cam lever adjustor9122. The lever9116, side cam lever adjustor9122, and clamp lower jaw9120ensemble may further include other dowels, screws, and pins to provide smooth actuation of the clamp lower jaw9120when the lever9116is adjusted.

An alternative clamp design9610(that could be used as clamp9110) is shown inFIGS. 37A-37B. The clamp9610functions in essentially the same manner as clamp9210for grabbing onto a rail or a surface. The primary difference between the clamps9610and9210is that in clamp9610, a lever9616that actuates a lower jaw9620(to bring it closer to the upper jaw9614) can be flipped from an up and down direction, while clamp9210actuates the clamp with a side to side motion of its lever.

Referring back toFIGS. 32A-32C, cable retainers9170(or clasps) can be used to maintain cables used for powering the medical device such that the cables do not become entangled. The cable retainers9170can also keep the cables away from the patient and/or prevent the cables from needlessly obstructing the medical personnel's view of the patient or treatment site during a procedure. As can be seen fromFIGS. 32A and 32B, the series of cable management retainers9170may be disposed along the length of segments9134and9139. The cable management retainers9170can be constructed to comfortably retain cables associated with the use of the medical device (e.g. power cables, signal cables, wires, and so forth). The cable management retainers9170can keep necessary cables associated with the medical device component clear of where healthcare professionals may be working.

An exemplary cable management retainers9470(which can be used as retainer9170) is shown inFIGS. 35A-35C. The cable management retainer9470includes a cable management top cover9171coupled with a cable management bottom piece9175. The cable management top cover9171includes a cable management top coupling channel9172that is capable of accepting a pin9179. The cable management top cover9171also includes a cable management torsion spring groove9173that is able to mate with a torsion spring9180. When in place, the torsion spring9180allows the cable management top cover9171to automatically snap back to a closed position after the cable management top cover9171has been flipped to an open position. This prevents cables or wires from inadvertently slipping out of the cable management retainer9470during the medical procedure and interfering with the medical procedure at hand.

The cable management bottom piece9175includes at least two cable management bottom channels9176such that when the cable management top coupling channel is seated between the two cable management bottom channels9176and a pin9179is inserted through the each of the channels, the cable management top cover9171mates with the cable management bottom piece9175and is able to pivot at with respect to the cable management bottom piece9175. The cable management bottom piece9175further includes a cable management bottom lip9177. The cable management bottom lip9177has a slanted outer edge such that when the cable management top cover9171is in contact with the cable management bottom piece9175, the slanted outer edge comes into contact with the shorter side of the tapered edge of the cable management top cover9171. The cable management top cover9171can also be slightly tapered underneath. The advantage of this configuration is that a user can easily catch the longer side of the tapered edge of the cable management top cover9171with his finger and easily insert or remove cables of choice, even if wearing gloves. The cable management bottom piece9175also includes at least one cable management bottom screw aperture9178, which allows the cable management clasp9170to be coupled to the support arm9130or other portion of the support arm assembly9100.

Referring back toFIGS. 32A-32C, the device mount9150can be configured to couple with, and hold steady, a medical device component that is greater than 5 pounds, greater than 10 pounds, or greater than 15 pounds, such as up to 20 pounds. For example, the device mount9150can be configured to maintain a catheter drive controller during use of the catheter (e.g., an atherectomy catheter).

An exemplary device mount9550(which can be used as device mount9150) is shown inFIGS. 36A-36B. The device mount9550includes a device mount stem9151. At one end of the device mount stem9151, a device mount base9152is attached. The device mount base9152extends perpendicularly away from the device mount stem9151. Disposed on the end of the device mount base9152opposite where it couples to the device mount stem9151, is a device mount post9154that extends in the direction of the device mount stem9151. The device mount stem9151may include coupling pin apertures9164for coupling to the device mount base9152and the device mount latch9153.

In the embodiment of the device mount9550, the device mount base9152also includes a device mount base stem aperture9160for coupling to the device mount stem9151and a device mount base post aperture9161that couples to the device mount post9154. The device mount post9154is configured to couple with the device component being supported so as to prevent the device component from detaching form the device mount9550during use and inadvertently injuring the patient. The device mount base9152may also include coupling pin apertures9164that may be tightened or loosened for either coupling to the device mount stem9151or the device mount post9154.

The device mount9550also includes a device mount latch9153at an intermediate position along the device mount stem9151. The device mount latch includes a device mount latch stem aperture9162for coupling to the device mount stem9151. The device mount latch9153may be adjusted along the device mount stem9151such that when a device has been coupled to the device mount post9154, the device mount latch9153may be lowered to contact the top surface of the device component, where then the device mount post9154may be tightened locking its position along the length of device mount stem9151for steadying the device component within device mount9550. In some instances, the device component having a corresponding cavity for accepting the device mount post9154may be swiveled to obtain the best viewing angle. Once the desired orientation of the device component has been obtained, the device mount latch may be used to maintain the orientation of the device component during use. While not shown the device mount latch may include a cushioning layer on its surfaces that come into contact with the device component.

The end of the device mount stem9151that is configured to couple to the device mount adjustor9143of the support arm9130includes a device mount stem notch9155. The device mount stem notch9155encompasses the entire circumference of the device mount stem9151. The device mount stem notch9155allows the device mount9150to be snapped into, and held within, the device mount coupler9142. The device mount coupler9142may have include internal mechanisms (not shown) that allow it to grip onto the device mount stem notch9155of the device mount9150. The device mount9550, when coupled to the support arm9130, can rotate along at least one axis of rotation. The device mount9150is able to rotate about the long axis of the device mount stem9151. In other examples, the device mount stem9151may be coupled to the device mount coupler9142by any suitable means known in the art including but not limited to hooks, clasps, clips, and so forth.

FIG. 36Cshows the device mount9550attached to a controller9666, e.g., a controller for an atherectomy catheter. The device mount9154can mate with a slot in the controller9666, and the controller9666can rest on the base9152. The device mount latch9153can help maintain the controller9666within the device mount9550. The device mount post9154height may range anywhere from approximately 1 cm to 3 cm. The device mount post9154advantageously does not interfere with the circuitry, layout, or function of the device component. The device mount9550is designed such that their weight when coupled to the device component provides reasonable counter weight to the support arm9130and thus does not over-stress the coupling between the clamp9110and its supporting element (e.g. bed rail). In some other examples, the device mount may include some other type of coupling mechanism. For example, the device mount base may include one or more protrusions or locking mechanism that are able to mate with features on the device component. The device mount base may include adjustable appendages that can grasp onto the device component or snap onto the device component. The device mount may include female couplers that are able to make with corresponding male couplers on the device component or vice versa.

FIG. 38shows another embodiment of a device mount9750. Instead of a device mount latch as that of device mount9550, the device mount9750is in a “C” configuration, where the top portion includes a device mount flap9253and the bottom portion has a device mount support base9252that is able to support the dimensions of the device component instead of coupling to the device component through a single attachment point. The device mount flap9253may be adjustable in distance with respect to the device mount support base9252. The device mount flap9253may be hingedly attached to the device mount support base9252such that it is able to hold the device component securely during use. It may also be possible for the device mount flap9253and the device mount support base9252to rotate about the longitudinal axis of a device mount post9254.

Further,FIGS. 39A-39Bshow another embodiment of a device mount9850. The device mount9850includes a base against which the controller9866sits. A device mount post9854can be configured to be rotated or screwed into a mating hole in the controller9866to hold it thereto.

FIGS. 40A-40Cshow yet another embodiment of a device mount9950.FIGS. 40A-40Bshows a device mount9350that is unattached, andFIG. 40Cshows the device mount9250securely attached to a controller9966. Similar to the device mount9750, device mount9950has a “C”-shaped configuration with a device mount post9354for coupling to the support arm. The device mount9350has an outer C holder9357and an inner C clasp9358. The inner C clasp9358may hingedly hold onto the device component during use. The distance between the two ends of the C clasp9358may also be adjusted to accommodate different device component heights.

Another exemplary device mount91050is shown inFIGS. 41A-41B. The device mount91050can be attached to a pivotable portion91092of a support arm91000. Further, the device mount91050can include a base91052configured to sit horizontal such that the controller91066can rest thereon. Device mount posts91054a,bcan be configured to mate with corresponding apertures on the controller91066to hold it in place.

The device mounts, support arm assemblies, and clamping mechanisms described herein can all be designed to be able to balance the weight of the device component being held such that the clamp is able to maintain secure contact with the rail or surface onto which it is clamped.

The devices described herein may include additional features not shown in the figures. For example, the device mount flap and/or the device mount support base may include cushioning material on the surfaces that would contact the device component. In other instances, the device mount portions that would contact the device component may include materials having greater friction so that the device component would not easily slip from the device mount while being maneuvered. Device mounts described herein may also include springs known in the art of clips and clamps that aid with maintaining pressure on the device component during use.

As noted above, the devices and techniques described herein can be used with OCT imaging. Exemplary imaging systems are described in co-pending applications: U.S. patent application Ser. No. 12/790,703, titled “OPTICAL COHERENCE TOMOGRAPHY FOR BIOLOGICAL IMAGING,” filed May 28, 2010, Publication No. US-2010-0305452-A1; U.S. patent application Ser. No. 12/829,267, titled “CATHETER-BASED OFF-AXIS OPTICAL COHERENCE TOMOGRAPHY IMAGING SYSTEM,” filed Jul. 1, 2010, Publication No. US-2010-0021926-A1; International Patent Application titled “OPTICAL COHERENCE TOMOGRAPHY WITH GRADED INDEX FIBER FOR BIOLOGICAL IMAGING,” filed Mar. 15, 2013, Publication No. WO-2013-172972, all of which are incorporated by reference in their entireties.

Additional details pertinent to the present invention, including materials and manufacturing techniques, may be employed as within the level of those with skill in the relevant art. The same may hold true with respect to method-based aspects of the invention in terms of additional acts commonly or logically employed. Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein. Likewise, reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a,” “and,” “said,” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. Unless defined otherwise herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The breadth of the present invention is not to be limited by the examples described herein, but only by the plain meaning of the claim terms employed.