Patent Description:
This document relates to rotational atherectomy devices and systems for removing or reducing stenotic lesions in blood vessels and/or arteriovenous grafts, for example, by rotating an abrasive element within the vessel to partially or completely remove the stenotic lesion material.

Blood flow through the peripheral arteries (e.g., iliac, femoral, renal etc.), can be affected by the development of atherosclerotic blockages. Peripheral artery disease (PAD) can be serious because without adequate blood flow, the kidneys, legs, arms, and feet may suffer irreversible damage. Left untreated, the tissue can die or harbor infection.

Patients that have kidneys that do not function properly may require hemodialysis to purify the blood of the patient. To gain access to the blood for hemodialysis, an arteriovenous fistula or a graft can be used to connect an artery and a vein. Similar to blood vessels, fistulas and/or grafts can become clogged with plaque.

<CIT> describes rotational atherectomy devices and systems can remove or reduce stenotic lesions in blood vessels by rotating an abrasive element within the vessel.

<CIT> describes a rotational atherectomy device for removing a stenotic tissue from the iliac artery of a patient.

<CIT> describes rotational atherectomy devices and systems for removing or reducing stenotic lesions in blood vessels by rotating an abrasive element within the vessel to partially or completely remove the stenotic lesion material.

<CIT> describes a rotational atherectomy device having, in various embodiments, a flexible, elongated, rotatable drive shaft with a system of eccentric abrading heads attached thereto.

This document relates to rotational atherectomy devices, systems, and methods for removing or reducing stenotic lesions in an implanted graft (e.g., a synthetic arteriovenous (AV) graft) by rotating one or more abrasive elements to abrade and breakdown the lesion. Vascular access stenosis is a common issue found in hemodialysis patients. In various embodiments, a graft can be implanted into a hemodialysis patient to access blood vessels capable of providing rapid extracorporeal blood flow during hemodialysis. The implanted graft may be prone to vascular access stenosis, which forms fibrous plaque-like lesions within the lumen of the graft and extending into the native artery and vein attached to the graft. Stenotic lesions that typically develop in association with the implanted graft can contain non-calcified neointimal hyperplasia and may lead to thrombosis and graft occlusion.

Some embodiments of the systems and devices provided herein can abrade stenotic lesions in the grafts by rotating the abrasive element(s) according to a stable and predictable orbiting profile. In some embodiments, the abrasive element(s) are attached to a distal portion of an elongate flexible drive shaft that extends from a handle assembly. In particular embodiments, a rotational atherectomy device comprises an elongate flexible drive shaft with multiple eccentric abrasive elements that are attached to the drive shaft, and one or more stability elements are attached to the drive shaft such that at least one stability element is distal of the abrasive element. Optionally, the stability elements have a center of mass that are axially aligned with a central longitudinal axis of the drive shaft while the eccentric abrasive element(s) has(have) a center(s) of mass that is(are) axially offset from central longitudinal axis of the drive shaft.

In some embodiments, multiple abrasive elements are coupled to the drive shaft and are offset from each other around the drive shaft such that the centers of the abrasive elements are disposed at differing radial angles from the drive shaft in relation to each other. For example, in some embodiments a path defined by the centers of mass of the abrasive elements defines a spiral around a length of the central longitudinal axis of the drive shaft. A flexible polymer coating may surround at least a portion of the drive shaft, including the stability element(s) in some embodiments. Also, in some optional embodiments, a distal extension portion of the drive shaft may extend distally beyond the distal-most stability element.

Some of the embodiments described herein may provide one or more of the following advantages. First, some embodiments of the rotational atherectomy devices and systems operate with a stable and predictable rotary motion profile for an atherectomy procedure applied to an implanted graft (e.g., synthetic AV graft) for the removal of stenotic plaque-like lesions from within the graft. That is, when the device is being rotated in operation, the eccentric abrasive element(s) follows a predefined, consistent orbital path (offset from an axis of rotation of the device) while the stability element(s) and other portions of the device remain on or near to the axis of rotation for the drive shaft in a stable manner. This predictable orbital motion profile can be attained by the use of design features including, but not limited to, stability element(s) that have centers of mass that are coaxial with the longitudinal axis of the drive shaft, a polymeric coating on at least a portion of the drive shaft, a distal-most drive shaft extension portion, and the like. Some embodiments of the rotational atherectomy devices and systems provided herein may include one or more of such design features.

Second, the rotational atherectomy devices provided herein may include a distal stability element that has an abrasive outer surface that allows a rotational atherectomy device, when being advanced within an implanted graft, to treat plaque-like lesions that occlude or substantially occlude the graft. In such applications, the abrasive outer surface on the distal stability element may help facilitate passage of the distal stability element through plaque-like lesions that occlude or substantially occlude the graft. In some such cases, the drive shaft may be used to rotate the distal stability element to help facilitate boring of the distal stability element through such lesions in a drill-like fashion.

Third, some embodiments of the rotational atherectomy devices and systems provided herein can be used to treat various graft sizes (e.g., large-diameter grafts having an internal diameter that is multiple time greater than the outer diameter of the abrasive element) while, in some embodiments, using a small introducer sheath size for delivery of the devices and systems. In other words, in some embodiments the rotating eccentric abrasive element(s) traces an orbital path that is substantially larger than the outer diameter of the rotational atherectomy device in the non-rotating state. This feature improves the ability of the rotational atherectomy devices provided herein to treat, in some embodiments, very large grafts while still fitting within a small introducer size. In some embodiments, this feature can be at least partially attained by using a helical array of abrasive elements that has a high eccentric mass (e.g., the centers of mass of the abrasive elements are significantly offset from the central longitudinal axis of the drive shaft). Further, in some embodiments this feature can be at least partially attained by using multiple abrasive elements that are radially offset from each other around the drive shaft such that the centers of the abrasive elements are not coaxial with each other.

Fourth, according to the claimed invention, in some embodiments rotational atherectomy systems described herein include user controls that are convenient and straight-forward to operate. In one such example, the user controls can include selectable elements that correspond to the diametric size of the implanted graft(s) to be treated. When the clinician-user selects the particular graft size, the system will determine an appropriate rpm of the drive shaft to obtain the desired orbit of the abrasive element(s) for the particular graft size. Hence, in such a case the clinician-user conveniently does not need to explicitly select or control the rpm of the drive shaft. In another example, the user controls can include selectable elements that correspond to the speed of drive shaft rotations. In some such examples, the user can conveniently select "low," "medium," or "high" speeds.

Referring to <FIG>, in some embodiments a rotational atherectomy system <NUM> for removing or reducing stenotic lesions in implanted grafts <NUM> (e.g., a synthetic AV graft) can include a rotational atherectomy device <NUM> and a controller <NUM>. In some embodiments, the rotational atherectomy device <NUM> can include a guidewire <NUM>, an actuator handle assembly <NUM>, and an elongate flexible drive shaft assembly <NUM>. The drive shaft assembly <NUM> extends distally from the handle assembly <NUM>. The controller <NUM> can be connected to the handle assembly <NUM> via a cable assembly <NUM>. The handle assembly <NUM> and controller <NUM> can be operated by a clinician to perform and control the rotational atherectomy procedure. In some embodiments, the actuator handle assembly <NUM> can be an electric handle that includes an electric motor, and can include speed controls, actuator buttons, and other functions to perform and control the rotational atherectomy procedure.

In the depicted embodiment, the elongate flexible drive shaft assembly <NUM> includes a sheath <NUM> and a flexible drive shaft <NUM>. A proximal end of the sheath <NUM> is fixed to a distal end of the handle assembly <NUM>. The flexible drive shaft <NUM> is slidably and rotatably disposed within a lumen of the sheath <NUM>. The flexible drive shaft <NUM> defines a longitudinal lumen in which the guidewire <NUM> is slidably disposed. As depicted, the flexible drive shaft <NUM> includes a torque-transmitting coil that defines the longitudinal lumen along a central longitudinal axis, and the drive shaft <NUM> is configured to rotate about the longitudinal axis while the sheath <NUM> remains generally stationary. Hence, as described further below, during a rotational atherectomy procedure the flexible drive shaft <NUM> is in motion (e.g., rotating and longitudinally translating) while the sheath <NUM> and the guidewire <NUM> are generally stationary.

The rotational atherectomy device <NUM> can include one or more abrasive elements <NUM> that are eccentrically-fixed to the drive shaft <NUM> proximal of a distal stability element <NUM>. In some embodiments, the distal stability element <NUM> is concentrically-fixed to the drive shaft <NUM> between the one or more abrasive elements <NUM> and a distal drive shaft extension portion. As such, the center of mass of the distal stability element <NUM> is aligned with the central axis of the drive shaft <NUM> while the center of mass of each abrasive element <NUM> is offset from the central axis of the drive shaft <NUM>.

Still referring to <FIG>, the graft <NUM> to be treated is in an arm <NUM> of a patient <NUM>. For example, the graft <NUM> may be located below an elbow of the patient <NUM>. In the depicted example, the graft <NUM> is a loop graft <NUM>. In some embodiments, the distal portion of the rotational atherectomy device <NUM> is introduced into the vasculature by penetrating through a wall of the graft <NUM>. In some embodiments, the graft <NUM> may be connecting a radial artery or a brachial artery <NUM> to a median cubital vein or a basilic vein <NUM>. As shown in the depicted embodiment, the rotational atherectomy device <NUM> is inserted such that a distal portion of the rotational atherectomy device <NUM> is pointed toward a venous vessel, such as a median cubital or basilic vein <NUM>. The abrasive elements <NUM> on the drive shaft <NUM> of the rotational atherectomy device <NUM> can be rotated to remove one or more lesions in the graft <NUM>.

In some embodiments, the graft <NUM> is a self-healing graft, such that punctures in the graft caused by insertion of the rotational atherectomy device <NUM> will close and heal without additional aid. In some embodiments, the graft <NUM> can have an outer diameter of from about <NUM> millimeters (mm) to about <NUM>.

Referring to <FIG>, in another example, the graft <NUM> to be treated is in an arm <NUM> of a patient <NUM>. For example, the graft <NUM> may be located below an elbow of the patient <NUM>. In the depicted example, the graft <NUM> is a straight graft <NUM>. In some embodiments, the graft <NUM> may be connecting a radial artery <NUM> to one of a median cubital vein, a basilic vein, or a cephalic vein <NUM>. In some embodiments, the rotational atherectomy device <NUM> can be inserted such that a distal portion of the rotational atherectomy device <NUM> is pointed toward the median cubital vein, the basilic vein, or the cephalic vein <NUM>. The abrasive elements on the rotational atherectomy device <NUM> can be rotated to remove a lesion in the graft <NUM>.

Referring to <FIG>, in some embodiments, the graft <NUM> to be treated is in an arm <NUM> of a patient <NUM>. For example, the graft <NUM> may be located below an elbow of the patient <NUM>. In some examples, the graft <NUM> is a loop graft <NUM>. In some embodiments, the graft <NUM> may be connecting a radial artery or a brachial artery <NUM> to a median cubital vein or a basilic vein <NUM>. In some embodiments, the rotational atherectomy device <NUM> can be inserted such that a distal portion of the rotational atherectomy device <NUM> is pointed toward the median cubital vein or the basilic vein <NUM>. The abrasive elements on the rotational atherectomy device <NUM> can be rotated to remove a lesion in the graft <NUM>.

Referring to <FIG>, in some examples, the graft <NUM> to be treated is in a torso <NUM> of a patient <NUM>. For example, the graft <NUM> may be located across a chest of the patient <NUM>. In some embodiments, the graft <NUM> may be connecting an axillary artery <NUM> to an axillary vein <NUM>. In the depicted embodiment, the rotational atherectomy device <NUM> can be inserted such that a distal portion of the rotational atherectomy device <NUM> is pointed toward the axillary vein <NUM>. The abrasive elements on the rotational atherectomy device <NUM> can be rotated to remove a lesion in the graft <NUM>.

Referring to <FIG>, in some examples, the graft <NUM> to be treated is in a torso <NUM> of a patient <NUM>. In some embodiments, the graft <NUM> may be connecting an axillary artery <NUM> to a saphenous vein <NUM> of the patient <NUM>. In the depicted embodiment, the rotational atherectomy device <NUM> can be inserted such that a distal portion of the rotational atherectomy device <NUM> is pointed toward the saphenous vein <NUM>. The abrasive elements on the rotational atherectomy device <NUM> can be rotated to remove a lesion in the graft <NUM>.

Referring back to <FIG>, in some optional embodiments, an inflatable member (not shown) can surround a distal end portion of the sheath <NUM>. Such an inflatable member can be selectively expandable between a deflated low-profile configuration and an inflated deployed configuration. The sheath <NUM> may define an inflation lumen through which the inflation fluid can pass (to and from the optional inflatable member). The inflatable member can be in the deflated low-profile configuration during the navigation of the drive shaft assembly <NUM> through the patient's graft to a target location. Then, at the target location, the inflatable member can be inflated so that the outer diameter of the inflatable member contacts the wall of the vessel. In that arrangement, the inflatable member advantageously stabilizes the drive shaft assembly <NUM> in the vessel during the rotational atherectomy procedure.

Still referring to <FIG>, the flexible drive shaft <NUM> is slidably and rotatably disposed within a lumen of the sheath <NUM>. A distal end portion of the drive shaft <NUM> extends distally of the distal end of the sheath <NUM> such that the distal end portion of the drive shaft <NUM> is exposed (e.g., not within the sheath <NUM>, at least not during the performance of the actual rotational atherectomy).

In the depicted embodiment, the exposed distal end portion of the drive shaft <NUM> includes one or more abrasive elements <NUM>, a (optional) distal stability element <NUM>, and a distal drive shaft extension portion <NUM>. In the depicted embodiment, the one or more abrasive elements <NUM> are eccentrically-fixed to the drive shaft <NUM> proximal of the distal stability element <NUM>. In this embodiment, the distal stability element <NUM> is concentrically-fixed to the drive shaft <NUM> between the one or more abrasive elements <NUM> and the distal drive shaft extension portion <NUM>. As such, the center of mass of the distal stability element <NUM> is aligned with the central axis of the drive shaft <NUM> while the center of mass of each abrasive element <NUM> is offset from the central axis of the drive shaft <NUM>. The distal drive shaft extension portion <NUM>, which includes the torque-transmitting coil, is configured to rotate about the longitudinal axis extends distally from the distal stability element <NUM> and terminates at a free end of the drive shaft <NUM>.

In some optional embodiments, a proximal stability element (not shown) is included. The proximal stability element can be constructed and configured similarly to the depicted embodiment of the distal stability element <NUM> (e.g., a metallic cylinder directly coupled to the torque-transmitting coil of the drive shaft <NUM> and concentric with the longitudinal axis of the drive shaft <NUM>) while being located proximal to the one or more abrasive elements <NUM>.

In the depicted embodiment, the distal stability element <NUM> has a center of mass that is axially aligned with a central longitudinal axis of the drive shaft <NUM>, while the one or more abrasive elements <NUM> (collectively and/or individually) have a center of mass that is axially offset from central longitudinal axis of the drive shaft <NUM>. Accordingly, as the drive shaft <NUM> is rotated about its longitudinal axis, the principle of centrifugal force will cause the one or more abrasive elements <NUM> (and the portion of the drive shaft <NUM> to which the one or more abrasive elements <NUM> are affixed) to follow a transverse generally circular orbit (e.g., somewhat similar to a "jump rope" orbital movement) relative to the central axis of the drive shaft <NUM> (as described below, for example, in connection with <FIG>). In general, faster speeds (rpm) of rotation of the drive shaft <NUM> will result in larger diameters of the orbit (within the limits of the graft diameter). The orbiting one or more abrasive elements <NUM> will contact the stenotic lesion to ablate or abrade the lesion to a reduced size (i.e., small particles of the lesion will be abraded from the lesion).

The rotating distal stability element <NUM> will remain generally at the longitudinal axis of the drive shaft <NUM> as the drive shaft <NUM> is rotated (as described below, for example, in connection with <FIG>). In some optional embodiments, two or more distal stability elements <NUM> are included. As described further below, contemporaneous with the rotation of the drive shaft <NUM>, the drive shaft <NUM> can be translated back and forth along the longitudinal axis of the drive shaft <NUM>. Hence, lesions can be abraded radially and longitudinally by virtue of the orbital rotation and translation of the one or more abrasive elements <NUM>, respectively.

The flexible drive shaft <NUM> of rotational atherectomy system <NUM> is laterally flexible so that the drive shaft <NUM> can readily conform to the non-linear grafts of the patient, and so that a portion of the drive shaft <NUM> at and adjacent to the one or more abrasive elements <NUM> will laterally deflect when acted on by the centrifugal forces resulting from the rotation of the one or more eccentric abrasive elements <NUM>. In this embodiment, the drive shaft <NUM> comprises one or more helically wound wires (or filars) that provide one or more torque-transmitting coils of the drive shaft <NUM> (as described below, for example, in connection with <FIG>). In some embodiments, the one or more helically wound wires are made of a metallic material such as, but not limited to, stainless steel (e.g., <NUM>, <NUM>, or 316LVM), nitinol, titanium, titanium alloys (e.g., titanium beta <NUM>), carbon steel, or another suitable metal or metal alloy. In some alternative embodiments, the filars are or include graphite, Kevlar, or a polymeric material. In some embodiments, the filars can be woven, rather than wound. In some embodiments, individual filars can comprise multiple strands of material that are twisted, woven, or otherwise coupled together to form a filar. In some embodiments, the filars have different cross-sectional geometries (size or shape) at different portions along the axial length of the drive shaft <NUM>. In some embodiments, the filars have a cross-sectional geometry other than a circle, e.g., an ovular, square, triangular, or another suitable shape.

In this embodiment, the drive shaft <NUM> has a hollow core. That is, the drive shaft <NUM> defines a central longitudinal lumen running therethrough. The lumen can be used to slidably receive the guidewire <NUM> therein, as will be described further below. In some embodiments, the lumen can be used to aspirate particulate or to convey fluids that are beneficial for the atherectomy procedure.

In some embodiments, the drive shaft <NUM> includes an optional coating on one or more portions of the outer diameter of the drive shaft <NUM>. The coating may also be described as a jacket, a sleeve, a covering, a casing, and the like. In some embodiments, the coating adds column strength to the drive shaft <NUM> to facilitate a greater ability to push the drive shaft <NUM> through stenotic lesions. In addition, the coating can enhance the rotational stability of the drive shaft <NUM> during use. In some embodiments, the coating is a flexible polymer coating that surrounds an outer diameter of the coil (but not the abrasive elements <NUM> or the distal stability element <NUM>) along at least a portion of drive shaft <NUM> (e.g., the distal portion of the drive shaft <NUM> exposed outwardly from the sheath <NUM>). In some embodiments, a portion of the drive shaft <NUM> or all of the drive shaft <NUM> is uncoated. In particular embodiments, the coating is a fluid impermeable material such that the lumen of the drive shaft <NUM> provides a fluid impermeable flow path along at least the coated portions of the drive shaft <NUM>.

The coating may be made of materials including, but not limited to, PEBEX, PICOFLEX, PTFE, ePTFE, FEP, PEEK, silicone, PVC, urethane, polyethylene, polypropylene, and the like, and combinations thereof. In some embodiments, the coating covers the distal stability element <NUM> and the distal extension portion <NUM>, thereby leaving only the one or more abrasive elements <NUM> exposed (non-coated) along the distal portion of the drive shaft <NUM>. In alternative embodiments, the distal stability element <NUM> is not covered with the coating, and thus would be exposed like the abrasive elements <NUM>. In some embodiments, two or more layers of the coating can be included on portions of the drive shaft <NUM>. Further, in some embodiments different coating materials (e.g., with different durometers and/or stiffnesses) can be used at different locations on the drive shaft <NUM>.

In the depicted embodiment, the distal stability element <NUM> is a metallic cylindrical member having an inner diameter that surrounds a portion of the outer diameter of the drive shaft <NUM>. In some embodiments, the distal stability element <NUM> has a longitudinal length that is greater than a maximum exterior diameter of the distal stability element <NUM>. In the depicted embodiment, the distal stability element <NUM> is coaxial with the longitudinal axis of the drive shaft <NUM>. Therefore, the center of mass of the distal stability element <NUM> is axially aligned (non-eccentric) with the longitudinal axis of the drive shaft <NUM>. In alternative rotational atherectomy device embodiments, stability element(s) that have centers of mass that are eccentric in relation to the longitudinal axis may be included in addition to, or as an alternative to, the coaxial stability elements <NUM>. For example, in some alternative embodiments, the stability element(s) can have centers of mass that are eccentric in relation to the longitudinal axis and that are offset <NUM> degrees (or otherwise oriented) in relation to the center of mass of the one or more abrasive elements <NUM>.

The distal stability element <NUM> may be made of a suitable biocompatible material, such as a higher-density biocompatible material. For example, in some embodiments the distal stability element <NUM> may be made of metallic materials such as stainless steel, tungsten, molybdenum, iridium, cobalt, cadmium, and the like, and alloys thereof. The distal stability element <NUM> has a fixed outer diameter. That is, the distal stability element <NUM> is not an expandable member in the depicted embodiment. The distal stability element <NUM> may be mounted to the filars of the drive shaft <NUM> using a biocompatible adhesive, by welding, by press fitting, and the like, and by combinations thereof. The coating may also be used in some embodiments to attach or to supplement the attachment of the distal stability element <NUM> to the filars of the drive shaft <NUM>. Alternatively, the distal stability element <NUM> can be integrally formed as a unitary structure with the filars of the drive shaft <NUM> (e.g., using filars of a different size or density, using filars that are double-wound to provide multiple filar layers, or the like). The maximum outer diameter of the distal stability element <NUM> may be smaller than the maximum outer diameters of the one or more abrasive elements <NUM>.

In some embodiments, the distal stability element <NUM> has an abrasive coating on its exterior surface. For example, in some embodiments a diamond coating (or other suitable type of abrasive coating) is disposed on the outer surface of the distal stability element <NUM>. In some cases, such an abrasive surface on the distal stability element <NUM> can help facilitate the passage of the distal stability element <NUM> through vessel restrictions (such as calcified areas of a blood vessel).

In some embodiments, the distal stability element <NUM> has an exterior cylindrical surface that is smoother and different from an abrasive exterior surface of the one or more abrasive elements <NUM>. That may be the case whether or not the distal stability element <NUM> have an abrasive coating on its exterior surface. In some embodiments, the abrasive coating on the exterior surface of the distal stability element <NUM> is rougher than the abrasive surfaces on the one or more abrasive elements <NUM>.

Still referring to <FIG>, the one or more abrasive elements <NUM> (which may also be referred to as a burr, multiple burrs, or (optionally) a helical array of burrs) can comprise a biocompatible material that is coated with an abrasive media such as diamond grit, diamond particles, silicon carbide, and the like. In the depicted embodiment, the abrasive elements <NUM> includes a total of five discrete abrasive elements that are spaced apart from each other. In some embodiments, one, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, or more than fifteen discrete abrasive elements are included as the one or more abrasive elements <NUM>. Each of the five discrete abrasive elements can include the abrasive media coating, such as a diamond grit coating.

In the depicted embodiment, the two outermost abrasive elements are smaller in maximum diameter than the three inner abrasive elements. In some embodiments, all of the abrasive elements are the same size. In particular embodiments, three or more different sizes of abrasive elements are included. Any and all such possible arrangements of sizes of abrasive elements are envisioned and within the scope of this disclosure.

Also, in the depicted embodiment, the center of mass of each abrasive element <NUM> is offset from the longitudinal axis of the drive shaft <NUM>. Therefore, as the eccentric one or more abrasive elements <NUM> are rotated (along an orbital path), at least a portion of the abrasive surface of the one or more abrasive elements <NUM> can make contact with surrounding stenotic lesion material. As with the distal stability element <NUM>, the eccentric one or more abrasive elements <NUM> may be mounted to the filars of the torque-transmitting coil of the drive shaft <NUM> using a biocompatible adhesive, high temperature solder, welding, press fitting, and the like. In some embodiments, a hypotube is crimped onto the drive shaft and an abrasive element is laser welded to the hypotube. Alternatively, the one or more abrasive elements <NUM> can be integrally formed as a unitary structure with the filars of the drive shaft <NUM> (e.g., using filars that are wound in a different pattern to create an axially offset structure, or the like).

In some embodiments, the spacing of the distal stability element <NUM> relative to the one or more abrasive elements <NUM> and the length of the distal extension portion <NUM> can be selected to advantageously provide a stable and predictable rotary motion profile during high-speed rotation of the drive shaft <NUM>. For example, in embodiments that include the distal drive shaft extension portion <NUM>, the ratio of the length of the distal drive shaft extension <NUM> to the distance between the centers of the one or more abrasive elements <NUM> and the distal stability element <NUM> is about <NUM>:<NUM>, about <NUM>:<NUM>, about <NUM>:<NUM>, about <NUM>:<NUM>, about <NUM>:<NUM>, about <NUM>:<NUM>, about <NUM>:<NUM>, about <NUM>:<NUM>, about <NUM>:<NUM>, or higher than <NUM>:<NUM>.

Still referring to <FIG>, the rotational atherectomy system <NUM> also includes the actuator handle assembly <NUM>. The actuator handle assembly <NUM> includes a housing and a carriage assembly. The carriage assembly is slidably translatable along the longitudinal axis of the handle assembly <NUM> as indicated by the arrow <NUM>. For example, in some embodiments the carriage assembly can be translated, without limitation, about <NUM> to about <NUM>, or about <NUM> to about <NUM>, or about <NUM> to about <NUM>, or about <NUM> to about <NUM>. As the carriage assembly is translated in relation to the housing, the drive shaft <NUM> translates in relation to the sheath <NUM> in a corresponding manner.

In the depicted embodiment, the carriage assembly includes a valve actuator. In some embodiments, an electric motor for driving rotations of the drive shaft <NUM> is coupled to the carriage assembly such that the valve actuator is an electrical switch instead. In the depicted embodiment, the valve actuator is a button that can be depressed to actuate a compressed gas control valve (on/off; defaulting to off) mounted to the carriage assembly. While the valve actuator is depressed, a compressed gas (e.g., air, nitrogen, etc.) is supplied through the valve to a turbine member that is rotatably coupled to the carriage assembly and fixedly coupled to the drive shaft <NUM>. Hence, an activation of the valve actuator will result in a rotation of the turbine member and, in turn, the drive shaft <NUM> (as depicted by arrow <NUM>). In some embodiments, the rotational atherectomy system <NUM> is configured to rotate the drive shaft <NUM> at a high speed of rotation (e.g., <NUM>,<NUM>-<NUM>,<NUM> rpm) such that the eccentric one or more abrasive elements <NUM> revolve in an orbital path to thereby contact and remove portions of a target lesion (even those portions of the lesion that are spaced farther from the axis of the drive shaft <NUM> than the maximum radius of the one or more abrasive elements <NUM>).

To operate the handle assembly <NUM> during a rotational atherectomy procedure, a clinician can grasp the carriage assembly and depress the valve actuator with the same hand. The clinician can move (translate) the carriage assembly distally and proximally by hand (e.g., back and forth in relation to the housing), while maintaining the valve actuator in the depressed state. In that manner, a target lesion(s) can be ablated radially and longitudinally by virtue of the resulting orbital rotation and translation of the one or more abrasive elements <NUM>, respectively.

During an atherectomy treatment, in some cases the guidewire <NUM> is left in position in relation to the drive shaft <NUM> generally as shown. For example, in some cases the portion of the guidewire <NUM> that is extending beyond the distal end of the drive shaft <NUM> (or extension portion <NUM>) is about <NUM> inches to about <NUM> inches (about <NUM> to about <NUM>), about <NUM> inches to about <NUM> inches (about <NUM> to about <NUM>), about <NUM> inches to about <NUM> inches (about <NUM> to about <NUM>), or about <NUM> inches to about <NUM> inches (about <NUM> to about <NUM>). In some cases, the guidewire <NUM> is pulled back to be within (while not extending distally from) the drive shaft <NUM> during an atherectomy treatment. The distal end of the guidewire <NUM> may be positioned anywhere within the drive shaft <NUM> during an atherectomy treatment. In some cases, the guidewire <NUM> may be completely removed from within the drive shaft during an atherectomy treatment. The extent to which the guidewire <NUM> is engaged with the drive shaft <NUM> during an atherectomy treatment may affect the size of the orbital path of the one or more abrasive elements <NUM>.

In the depicted embodiment, the handle assembly <NUM> also includes a guidewire detention mechanism <NUM>. The guidewire detention mechanism <NUM> can be selectively actuated (e.g., rotated) to releasably clamp and maintain the guidewire <NUM> in a stationary position relative to the handle assembly <NUM> (and, in turn, stationary in relation to rotations of the drive shaft <NUM> during an atherectomy treatment). While the drive shaft <NUM> and handle assembly <NUM> are being advanced over the guidewire <NUM> to put the one or more abrasive elements <NUM> into a targeted position within a patient's graft <NUM>, the guidewire detention mechanism <NUM> will be unactuated so that the handle assembly <NUM> is free to slide in relation to the guidewire <NUM>. Then, when the clinician is ready to begin the atherectomy treatment, the guidewire detention mechanism <NUM> can be actuated to releasably detain/lock the guidewire <NUM> in relation to the handle assembly <NUM>. That way the guidewire <NUM> will not rotate while the drive shaft <NUM> is rotating, and the guidewire <NUM> will not translate while the carriage assembly is being manually translated.

Still referring to <FIG>, the rotational atherectomy system <NUM> also includes the controller <NUM>. In the depicted embodiment, the controller <NUM> includes a user interface that includes a plurality of selectable inputs that correspond to a plurality of vessel sizes (diameters). To operate the rotational atherectomy system <NUM>, the user can select a particular one of the selectable inputs that corresponds to the diameter of the vessel being treated. In response, the controller <NUM> will determine the appropriate gas pressure for rotating the drive shaft <NUM> in a vessel of the selected diameter (faster rpm for larger vessels and slower rpm for smaller vessel), and supply the gas at the appropriate pressure to the handle assembly <NUM>.

In some embodiments, the controller <NUM> is pole-mounted. The controller <NUM> can be used to control particular operations of the handle assembly <NUM> and the drive shaft assembly <NUM>. For example, the controller <NUM> can be used to compute, display, and adjust the rotational speed of the drive shaft <NUM>.

In some embodiments, the controller <NUM> can include electronic controls that are in electrical communication with a turbine RPM sensor located on the carriage assembly. The controller <NUM> can convert the signal(s) from the sensor into a corresponding RPM quantity and display the RPM on the user interface. If a speed adjustment is desired, the clinician can increase or decrease the rotational speed of the drive shaft <NUM>. In result, a flow or pressure of compressed gas supplied from the controller <NUM> to the handle assembly <NUM> (via the cable assembly <NUM>) will be modulated. The modulation of the flow or pressure of the compressed gas will result in a corresponding modulation of the RPM of the turbine member and of the drive shaft <NUM>.

In some embodiments, the controller <NUM> includes one or more interlock features that can enhance the functionality of the rotational atherectomy system <NUM>. In one such example, if the controller <NUM> does not detect any electrical signal (or a proper signal) from the turbine RPM sensor, the controller <NUM> can discontinue the supply of compressed gas. In another example, if a pressure of a flush liquid supplied to the sheath <NUM> is below a threshold pressure value, the controller <NUM> can discontinue the supply of compressed gas.

Still referring to <FIG>, the rotational atherectomy system <NUM> can include an electric handle with an electric motor. In some embodiments, the electric handle can include a user interface that includes a plurality of selectable inputs that correspond to a plurality of vessel sizes (diameters). To operate the rotational atherectomy system <NUM>, the user can select a particular one of the selectable inputs that corresponds to the diameter of the vessel being treated. In response, the electric handle will determine the appropriate rpm for rotating the drive shaft <NUM> in a vessel of the selected diameter (faster rpm for larger vessels and slower rpm for smaller vessel), and operate the electric motor accordingly.

Referring to <FIG>, the rotational atherectomy system <NUM> also includes the controller <NUM>. In the depicted embodiment according to the invention, the controller <NUM> includes a user interface that includes a plurality of selectable inputs that correspond to a plurality of graft sizes (diameters). Other types of user interfaces are also envisioned. To operate the rotational atherectomy system <NUM>, the user can select a particular one of the selectable inputs that corresponds to the diameter of the graft being treated. In response, the controller <NUM> will determine the appropriate gas pressure for rotating the one or more abrasive elements <NUM> in a graft of the selected diameter (faster RPM for larger grafts and slower RPM for smaller grafts), and supply the gas at the appropriate pressure to the handle assembly <NUM>. In some embodiments, the driver for rotation of the one or more abrasive elements <NUM> is an electrical motor rather than the pneumatic motor included in the depicted example. In the depicted example, the graft <NUM> to be treated is in a leg <NUM> of a patient. In particular, the graft <NUM> is above a knee (e.g., between a femoral artery and a saphenous vein, without limitation).

In some embodiments, the user interface is configured such that the user can simply select either "LOW," "MED," or "HIGH" speed via the selectable inputs. Based on the user's selection of either "LOW," "MED," or "HIGH," the controller <NUM> will provide a corresponding output for rotating the drive shaft at a corresponding rotational speed. It should be understood that the user interfaces are merely exemplary and nonlimiting. That is, other types of user interface controls can also be suitably used, and are envisioned within the scope of this disclosure.

Referring to <FIG>, the rotational atherectomy system <NUM> can be used to treat a graft <NUM> having a stenotic lesion <NUM> along an inner wall <NUM> of the graft <NUM>. The rotational atherectomy system <NUM> is used to fully or partially remove the stenotic lesion <NUM>, thereby removing or reducing the blockage within the graft <NUM> caused by the stenotic lesion <NUM>. By performing such a treatment, the blood flow through the graft <NUM> may be thereafter increased or otherwise improved. The graft <NUM> and lesion <NUM> are shown in longitudinal cross-sectional views to enable visualization of the rotational atherectomy system <NUM>.

Briefly, in some implementations the following activities may occur to achieve the deployed arrangement shown in <FIG>. In some embodiments, an introducer sheath (not shown) can be percutaneously advanced into the vasculature of the patient. The guidewire <NUM> can then be inserted through a lumen of the introducer sheath and navigated within the patient's graft <NUM> to a target location (e.g., the location of the lesion <NUM>). Techniques such as x-ray fluoroscopy or ultrasonic imaging may be used to provide visualization of the guidewire <NUM> and other atherectomy system components during placement. In some embodiments, no introducer sheath is used and the guidewire <NUM> is inserted without assistance from a sheath.

Next, portions of the rotational atherectomy system <NUM> can be inserted over the guidewire <NUM>. For example, an opening to the lumen of the drive shaft <NUM> at the distal free end of the drive shaft <NUM> (e.g., at the distal end of the optional distal drive shaft extension portion <NUM>) can be placed onto the guidewire <NUM>, and then the drive shaft assembly <NUM> and handle assembly <NUM> can be gradually advanced over the guidewire <NUM> to the position in relation to the lesion <NUM>. In some cases, the drive shaft <NUM> is disposed fully within the lumen of the sheath <NUM> during the advancing. In some cases, a distal end portion of the drive shaft <NUM> extends from the distal end opening <NUM> of the sheath <NUM> during the advancing. Eventually, after enough advancing, the proximal end of the guidewire <NUM> will extend proximally from the handle assembly <NUM> (via the access port <NUM> defined by the handle housing).

In some cases (such as in the depicted example), the lesion <NUM> may be so large (i.e., so extensively occluding the vessel <NUM>) that it is difficult or impossible to push the distal stability element <NUM> through the lesion <NUM>. In some such cases, an abrasive outer surface on the distal stability element <NUM> can be used to help facilitate passage of the distal stability element <NUM> into or through the lesion <NUM>. In some such cases, the drive shaft <NUM> can be rotated to further help facilitate the distal stability element <NUM> to bore into/through the lesion <NUM>.

Next, as depicted by <FIG>, the rotation and translational motions of the drive shaft <NUM> (and the one or more abrasive elements <NUM>) can be commenced to perform ablation of the lesion <NUM>.

In some implementations, prior to the ablation of the lesion <NUM> by the one or more abrasive elements <NUM>, an inflatable member can be used as an angioplasty balloon to treat the lesion <NUM>. That is, an inflatable member (on the sheath <NUM>, for example) can be positioned within the lesion <NUM> and then inflated to compress the lesion <NUM> against the inner wall <NUM> of the graft <NUM>. Thereafter, the rotational atherectomy procedure can be performed. In some implementations, such an inflatable member can be used as an angioplasty balloon after the rotational atherectomy procedure is performed. In some implementations, additionally or alternatively, a stent can be placed at lesion <NUM> using an inflatable member on the sheath <NUM> (or another balloon member associated with the drive shaft assembly <NUM>) after the rotational atherectomy procedure is performed.

The guidewire <NUM> may remain extending from the distal end of the drive shaft <NUM> during the atherectomy procedure as shown. For example, as depicted by <FIG>, the guidewire <NUM> extends through the lumen of the drive shaft <NUM> and further extends distally of the distal end of the distal extension portion <NUM> during the rotation and translational motions of the drive shaft <NUM> (refer, for example, to <FIG>). In some alternative implementations, the guidewire <NUM> is withdrawn completely out of the lumen of the drive shaft <NUM> prior to during the rotation and translational motions of the drive shaft <NUM> for abrading the lesion <NUM>. In other implementations, the guidewire <NUM> is withdrawn only partially. That is, in some implementations a portion of the guidewire <NUM> remains within the lumen of the drive shaft <NUM> during rotation of the drive shaft <NUM>, but remains only in a proximal portion that is not subject to the significant orbital path in the area of the one or more abrasive elements <NUM> (e.g., remains within the portion of the drive shaft <NUM> that remains in the sheath <NUM>).

To perform the atherectomy procedure, the drive shaft <NUM> is rotated at a high rate of rotation (e.g., <NUM>,<NUM>-<NUM>,<NUM> rpm) such that the eccentric one or more abrasive elements <NUM> revolve in an orbital path about an axis of rotation and thereby contacts and removes portions of the lesion <NUM>.

Still referring to <FIG>, the rotational atherectomy system <NUM> is depicted during the high-speed rotation of the drive shaft <NUM>. The centrifugal force acting on the eccentrically weighted one or more abrasive elements <NUM> causes the one or more abrasive elements <NUM> to orbit in an orbital path around the axis of rotation <NUM>. In some implementations, the orbital path can be somewhat similar to the orbital motion of a "jump rope. " As shown, some portions of the drive shaft <NUM> (e.g., a portion that is just distal of the sheath <NUM> and another portion that is distal of the distal stability element <NUM>) can remain in general alignment with the axis of rotation <NUM>, but the particular portion of the drive shaft <NUM> adjacent to the one or more abrasive elements <NUM> is not aligned with the axis of rotation <NUM> (and instead orbits around the axis <NUM>). As such, in some implementations, the axis of rotation <NUM> may be aligned with the longitudinal axis of a proximal part of the drive shaft <NUM> (e.g., a part within the distal end of the sheath <NUM>) and with the longitudinal axis of the distal extension portion <NUM> of the drive shaft <NUM>.

In some implementations, as the one or more abrasive elements <NUM> rotates, the clinician operator slowly advances the carriage assembly distally (and, optionally, reciprocates both distally and proximally) in a longitudinal translation direction so that the abrasive surface of the one or more abrasive elements <NUM> scrapes against additional portions of the occluding lesion <NUM> to reduce the size of the occlusion, and to thereby improve the blood flow through the graft <NUM>. This combination of rotational and translational motion of the one or more abrasive elements <NUM> is depicted by the sequence of <FIG>.

In some embodiments, the sheath <NUM> may define one or more lumens (e.g., the same lumen as, or another lumen than, the lumen in which the drive shaft <NUM> is located) that can be used for aspiration (e.g., of abraded particles of the lesion <NUM>). In some cases, such lumens can be additionally or alternatively used to deliver perfusion and/or therapeutic substances to the location of the lesion <NUM>, or to prevent backflow of blood from graft <NUM> into sheath <NUM>.

Referring to <FIG>, a distal end portion of the drive shaft <NUM> is shown in a longitudinal cross-sectional view. The distal end portion of the drive shaft <NUM> includes the one or more abrasive elements <NUM> that are eccentrically-fixed to the drive shaft <NUM>, the distal stability element <NUM> with an abrasive outer surface, and the distal drive shaft extension portion <NUM>.

In the depicted embodiment, the one or more abrasive elements <NUM> includes a total of five discrete abrasive elements that are spaced apart from each other. In some embodiments, one, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, or more than fifteen discrete abrasive elements are included as the one or more abrasive elements <NUM>. Each of the five discrete abrasive elements can include the abrasive media coating.

In the depicted embodiment, the two outermost abrasive elements of the abrasive elements <NUM> are smaller in maximum diameter than the three inner abrasive elements of the abrasive elements <NUM>. In some embodiments, all of the abrasive elements are the same size. In particular embodiments, three or more different sizes of abrasive elements <NUM> are included. Any and all such possible arrangements of sizes of abrasive elements <NUM> are envisioned and within the scope of this disclosure.

The one or more abrasive elements <NUM> can be made to any suitable size. For clarity, the size of the one or more abrasive elements <NUM> will refer herein to the maximum outer diameter of individual abrasive elements of the one or more abrasive elements <NUM>. In some embodiments, the one or more abrasive elements <NUM> are about <NUM> in size (maximum outer diameter). In some embodiments, the size of the one or more abrasive elements <NUM> is in a range of about <NUM> to about <NUM>, or about <NUM> to about <NUM>, or about <NUM> to about <NUM>, without limitation. Again, in a single embodiment, one or more of the abrasive elements <NUM> can have a different size in comparison to the other abrasive elements <NUM>. In some embodiments, the two outermost abrasive elements are about <NUM> in diameter and the inner abrasive elements are about <NUM> in diameter.

In the depicted embodiment, the one or more abrasive elements <NUM>, individually, are oblong in shape. A variety of different shapes can be used for the one or more abrasive elements <NUM>. For example, in some embodiments the one or more abrasive elements <NUM> are individually shaped as spheres, discs, rods, cylinders, polyhedrons, cubes, prisms, and the like. In some embodiments, such as the depicted embodiment, all of the one or more abrasive elements <NUM> are the same shape. In particular embodiments, one or more of the abrasive elements <NUM> has a different shape than one or more of the other abrasive elements <NUM>. That is, two, three, or more differing shapes of individual abrasive elements <NUM> can be combined on the same drive shaft <NUM>.

In the depicted embodiment, adjacent abrasive elements of the one or more abrasive elements <NUM> are spaced apart from each other. For example, in the depicted embodiment the two distal-most individual abrasive elements are spaced apart from each other by a distance 'X'. In some embodiments, the spacing between adjacent abrasive elements is consistent between all of the one or more abrasive elements <NUM>. Alternatively, in some embodiments the spacing between some adjacent pairs of abrasive elements differs from the spacing between other adjacent pairs of abrasive elements.

In some embodiments, the spacing distance X in ratio to the maximum diameter of the abrasive elements <NUM> is about <NUM>:<NUM>. That is, the spacing distance X is about equal to the maximum diameter. The spacing distance X can be selected to provide a desired degree of flexibility of the portion of the drive shaft <NUM> to which the one or more abrasive elements <NUM> are attached. In some embodiments, the ratio is about <NUM>:<NUM> (i.e., X is about <NUM> times longer than the maximum diameter). In some embodiments, the ratio is in a range of about <NUM>:<NUM> to about <NUM>:<NUM>, or about <NUM>:<NUM> to about <NUM>:<NUM>, or about <NUM>:<NUM> to about <NUM>:<NUM>, or about <NUM>:<NUM> to about <NUM>:<NUM>, or about <NUM>:<NUM> to about <NUM>:<NUM>, or about <NUM>:<NUM> to about <NUM>:<NUM>, or about <NUM>:<NUM> to about <NUM>:<NUM>, or about <NUM>:<NUM> to about <NUM>:<NUM>, or about <NUM>:<NUM> to about <NUM>:<NUM>, or about <NUM>:<NUM> to about <NUM>:<NUM>, or about <NUM>:<NUM> to about <NUM>:<NUM>, or about <NUM>:<NUM> to about <NUM>:<NUM>, or about <NUM>:<NUM> to about <NUM>:<NUM>, and anywhere between or beyond those ranges.

In the depicted embodiment, the center of mass of each one of the one or more abrasive elements <NUM> is offset from the longitudinal axis of the drive shaft <NUM> along a same radial angle. Said another way, the centers of mass of all of the one or more abrasive elements <NUM> are coplanar with the longitudinal axis of the drive shaft <NUM>. If the size of each of the one or more abrasive elements <NUM> is equal, the centers of mass of the one or more abrasive elements <NUM> would be collinear on a line that is parallel to the longitudinal axis of the drive shaft <NUM>.

Referring to <FIG>, according to some embodiments of the rotational atherectomy devices provided herein, one or more abrasive elements <NUM> are arranged at differing radial angles in relation to the drive shaft <NUM>. In such a case, a path defined by the centers of mass of the one or more abrasive elements <NUM> spirals along the drive shaft <NUM>. In some cases (e.g., when the diameters of the one or more abrasive elements <NUM> are equal and the adjacent abrasive elements are all equally spaced), the centers of mass of the one or more abrasive elements <NUM> define a helical path along/around the drive shaft <NUM>. It has been found that such arrangements can provide a desirably-shaped orbital rotation of the one or more abrasive elements <NUM>.

It should be understood that any of the structural features described in the context of one embodiment of the rotational atherectomy devices provided herein can be combined with any of the structural features described in the context of one or more other embodiments of the rotational atherectomy devices provided herein. For example, the size and/or shape features of the one or more abrasive elements <NUM> can be incorporated in any desired combination with the spiral arrangement of the one or more abrasive elements <NUM>.

Referring also to <FIG>, the differing radial angles of the individual abrasive elements 144a, 144b, 144c, 144d, and 144e can be further visualized. To avoid confusion, each figure of FIGS. <NUM>-<NUM> illustrates only the closest one of the individual abrasive elements 144a, 144b, 144c, 144d, and 144e (i.e., closest in terms of the corresponding cutting-plane as shown in <FIG>). For example, in <FIG>, abrasive element 144b is shown, but abrasive element 144a is not shown (so that the radial orientation of the abrasive element 144b is clearly depicted).

It can be seen in <FIG> that the centers of mass of abrasive elements 144a, 144b, 144c, 144d, and 144e are at differing radial angles in relation to the drive shaft <NUM>. Hence, it can be said that the abrasive elements 144a, 144b, 144c, 144d, and 144e are disposed at differing radial angles in relation to the drive shaft <NUM>.

In the depicted embodiment, the radial angles of the abrasive elements 144a, 144b, 144c, 144d, and 144e differ from each other by a consistent <NUM> degrees (approximately) in comparison to the adjacent abrasive element(s). For example, the center of mass of abrasive element 144b is disposed at a radial angle B that is about <NUM> degrees different than the angle at which the center of mass of abrasive element 144a is disposed, and about <NUM> degrees different than the angle C at which the center of mass of abrasive element 144c is disposed. Similarly, the center of mass of abrasive element 144c is disposed at a radial angle C that is about <NUM> degrees different than the angle B at which the center of mass of abrasive element 144b is disposed, and about <NUM> degrees different than the angle D at which the center of mass of abrasive element 144d is disposed. The same type of relative relationships can be said about abrasive element 144d.

While the depicted embodiment has a relative radial offset of <NUM> degrees (approximately) in comparison to the adjacent abrasive element(s), a variety of other relative radial offsets are envisioned. For example, in some embodiments the relative radial offsets of the adjacent abrasive elements is in a range of about <NUM> degrees to about <NUM> degrees, or about <NUM> degrees to about <NUM> degrees, or about <NUM> degrees to about <NUM> degrees, or about <NUM> degrees to about <NUM> degrees, or about <NUM> degrees to about <NUM> degrees, or about <NUM> degrees to about <NUM> degrees, or about <NUM> degrees to about <NUM> degrees, or about <NUM> degrees to about <NUM> degrees, or about <NUM> degrees to about <NUM> degrees, or about <NUM> degrees to about <NUM> degrees.

While in the depicted embodiment, the relative radial offsets of the abrasive elements 144a, 144b, 144c, 144d, and 144e in comparison to the adjacent abrasive element(s) are consistent, in some embodiments some abrasive elements are radially offset to a greater or lesser extent than others. For example, while angles B, C, D, and E are all multiples of <NUM> degrees, in some embodiments one or more of the angles B, C, D, and/or E is not a multiple of the same angle as the others.

The direction of the spiral defined by the centers of mass of the abrasive elements 144a, 144b, 144c, 144d, and 144e can be in either direction around the drive shaft <NUM>, and in either the same direction as the wind of the filars or in the opposing direction as the wind of the filars.

Claim 1:
A device (<NUM>) for performing rotational atherectomy to remove stenotic lesion material from an arteriovenous graft (<NUM>) of a patient, wherein the rotational atherectomy device comprises:
an elongate flexible drive shaft (<NUM>) comprising a torque-transmitting coil and defining a longitudinal axis, the drive shaft being configured to rotate about the longitudinal axis; and
first and second abrasive elements (<NUM>) attached to a distal end portion of the drive shaft and each having a center of mass offset from the longitudinal axis, the center of mass of the first abrasive element being offset from the longitudinal axis at a first radial angle, the center of mass of the second abrasive element being offset from the longitudinal axis at a second radial angle that differs from the first radial angle; and
a controller (<NUM>) or a handle that includes a user interface that includes a plurality of selectable inputs that correspond to diametric sizes of a plurality of grafts.