Patent Description:
<CIT> discloses an apparatus for dislodging and macerating an obstruction, such as wall adherent thrombus, in a body lumen and for simultaneously aspirating the effluent created by the dislodging and maceration of the obstruction. The apparatus includes a catheter defining at least two channels individually accommodating inlet and return fluid flow paths, a guidewire longitudinally extending through one of the channels of the catheter, and a system for rotating the guidewire.

<CIT> discloses a motorized mechanism to helicopter a guidewire in continuous clockwise and counter-clockwise rotations.

In an embodiment of the present disclosure, a system for treating a patient having thrombus includes an aspiration catheter having a distal end, a proximal end, and an aspiration lumen extending between the distal end and the proximal end and configured to be coupled to a vacuum source, an elongate member having a distal end and a proximal end, and configured for placement through the aspiration lumen of the aspiration catheter, a manipulation device including a housing configured to be supported by the hand of a user, the housing having a distal end and a proximal end, a drive system disposed within the housing, and configured to rotate a rotation member, an engagement member coupled to the rotation member, and configured to be removably coupled to the elongate member to transfer rotational movement of the rotation member to rotational movement of the elongate member, an activation member carried by the housing such that it can be operated by at least a portion of the hand of the user when the housing is supported by the hand of the user, and wherein the drive system if configured to apply motive force to the engagement member to thereby move the elongate member.

Embodiments of the present disclosure comprise systems and methods for manipulating one or more medical devices. The medical devices may include elongated medical devices including, but not limited to: guidewires (guide wires), maceration devices, for example maceration devices having an expending element (such as a basket), cutting devices, atherectomy devices, and a variety of different catheter shafts, including solid catheter shafts and hollow catheter shafts. Conventional guidewire manual manipulation methods often involve applying torque to the guidewire to aid its passage through tortuous, occluded, or stenosed conduits or vessels. The user may sometimes spin the guidewire within the fingers (e.g., gloved fingers) to create a torque which assists in manipulating the guidewire through the challenging anatomy. This technique is sometimes referred to as "helicoptering," alluding to the spinning blades of a helicopter. This technique can be difficult to achieve because the typically small diameter of guidewires makes them difficult to grip. Additionally, it may be difficult to apply necessary friction to the surface of the guidewire to cause them to rotate, because guidewires are often covered with a lubricious coating. For similar reasons, it may be difficult to place a longitudinal force on the guidewires with manual manipulation, including a back-and-forth longitudinal force intended for placing an oscillatory motion on the guidewire.

<FIG> illustrates an embodiment of a guidewire manipulation device <NUM> which is advanced over a guidewire <NUM>. As seen in this figure, the guidewire <NUM> is introduced into a blood vessel of the patient (e.g., a femoral artery). The manipulation device <NUM> is slid over the guidewire <NUM> and selectively locked on to the guidewire <NUM>. As the guidewire <NUM> is advance into the patient, the user operates the manipulation device <NUM> to rotate or vibrate the guidewire <NUM> as appropriate.

For example, as a distal end of the guidewire <NUM> reaches an angled or curved region of the vessel, the user activates the manipulation device <NUM> to rotate the guidewire <NUM> (i.e., in a counter clockwise direction indicated by arrow <NUM>), thereby causing the distal end of the guidewire <NUM> to more easily advance through the angled or curved region. In another example, the distal end of the guidewire <NUM> reaches an obstruction (e.g., an embolism) but is unable to easily pass. The user then activates the guidewire manipulation device <NUM> to vibrate (e.g., by routing between a clockwise and counter clockwise direction quickly), thereby causing the distal end of the guidewire <NUM> to pass through the obstruction. In another example, the device <NUM> may include a multiple, preprogrammed rotation patterns appropriate for different vessel configurations (e.g., a <NUM> degree clockwise rotation followed by <NUM> degree counter-clockwise rotation, a <NUM> degree clockwise rotation followed by <NUM> degree counter clockwise rotation or a <NUM> degree clockwise rotation followed by <NUM> degree counter clockwise rotation).

<FIG> illustrate external views of the guidewire manipulation device <NUM>. The guidewire manipulation device <NUM> may also include a microprocessor and memory connected to the motor and a button <NUM> for storing and executing the preprogrammed rotation patterns. As seen in these figures, the guidewire <NUM> passes through a passage along the length of the guidewire manipulation device <NUM>. Preferably, the guidewire manipulation device <NUM> includes a locking assembly in the form of a guidewire lock switch <NUM> which allows the user to selectively lock the guidewire manipulation device <NUM> to the guidewire <NUM>. In this respect, the guidewire manipulation device <NUM> can move relative to the guidewire <NUM> in an unlocked state, and can move the guidewire <NUM> (rotationally and/or longitudinally) in a locked state.

The guidewire manipulation device <NUM> also preferably includes a power indicator light <NUM> (e.g., an LED) which indicates if the device <NUM> is powered on and a rotation button <NUM> which causes the guidewire <NUM> to rotate. By pressing the button <NUM>, the user activates the device <NUM>. Optionally, the device <NUM> may include a button, switch or similar mechanism to toggle the device <NUM> between rotating in a clockwise direction or a counter-clockwise direction. Alternately, the button <NUM> may include multiple actuation techniques for determining clockwise or counter-clockwise rotation (e.g., sliding forward or backward, multiple button presses, etc.).

Preferably, an outer container or casing <NUM> is composed of a light-weight material such as plastic and has an ergonomic shape that at least partially fits in the user's hand. In this respect, the user can comfortably operate the guidewire manipulation device <NUM> during a procedure.

Referring to <FIG>, an interior view of the guidewire manipulation device <NUM> within the outer easing <NUM> is illustrated according to an embodiment of the present disclosure. The guidewire <NUM> is engaged by the device <NUM> with elongated rollers <NUM> (also seen in the cross sectional view of <FIG>). Preferably the device <NUM> includes at least three rollers, however, any number of rollers <NUM> are possible (e.g., <NUM>-<NUM> rollers). When; the button <NUM> is pressed, the rollers <NUM> rotate, thereby rotating the guidewire <NUM>. Preferably, the lock switch <NUM> raises or lowers one or more of the rollers <NUM> in relation to the guidewire <NUM>, so as to lock the guidewire <NUM> with the device <NUM> when the rollers <NUM> are pressed against the guidewire <NUM> and unlock the guidewire <NUM> from the device <NUM> when the roller(s) <NUM> are moved away from the guidewire <NUM>.

One or more of the rollers <NUM> are preferably driven by a motor <NUM> which is powered by battery <NUM> (or alternately by A. power such as an outlet). The motor <NUM> connects to the roller(s) <NUM> by a cam <NUM> made up of a first linkage <NUM> connected to the motor <NUM> and a second linkage <NUM> connected to the roller(s) <NUM>. In this respect, activation of the motor <NUM> drives the cam <NUM> and ultimately rotation of one or more of the rollers <NUM>.

<FIG> illustrate another embodiment of a manual manipulation device <NUM> according to the present disclosure. The device <NUM> is generally similar to the previously described device <NUM>, except that the rollers <NUM> and therefore rotation at the guidewire <NUM> is driven by a handle <NUM>. For example, depressing the handle <NUM> rotates the guidewire <NUM> in a clockwise direction (arrow <NUM>) and releasing the handle <NUM> rotates the guidewire <NUM> in a counter clockwise direction (arrow <NUM>). Additionally, a switch <NUM> is included to change a type of rotation caused by the handle <NUM>. For example, the switch <NUM> may change a gear ratio and therefore the amount of rotation cause by depressing the handle. In another example, the switch <NUM> may change directions of rotation caused by depressing the handle <NUM>. By manual activation of the handle <NUM> by the user, the internal drive components drive the rotation of the guidewire <NUM> without the need of a motor <NUM>.

<FIG> illustrate another embodiment of a manual guidewire manipulation device <NUM> which is generally similar to the previously described devices <NUM> and <NUM>. However, the device <NUM> includes a selectively locking thumb roller <NUM> on a distal end of the device <NUM>. The thumb roller <NUM> includes a locked mode, seen in <FIG>, in which the roller <NUM> is engaged with the guidewire <NUM>, thereby allowing the user to roll the roller <NUM> and thus the guidewire <NUM>. The thumb roller <NUM> also includes an unlocked mode, seen in <FIG>, in which the roller <NUM> is pulled distally from the casing <NUM>, exposing space <NUM> and disengaging the roller <NUM> from the guidewire <NUM>. Thus, in the unlocked mode, the device <NUM> can be moved along the length of the guidewire <NUM>.

<FIG> illustrate another embodiment of a guidewire manipulation device <NUM> according to an embodiment of the present disclosure. The device <NUM> is generally similar to the previously described device <NUM>. For example, the device <NUM> includes a hand-held (e.g., configured to be held within a user's hand), ergonomic, outer case <NUM> and a manipulation button <NUM>. As best seen in <FIG>, the device <NUM> also includes a motor <NUM> powered by a battery <NUM> and a guidewire passage <NUM> configured for passing the guidewire <NUM>.

Preferably, the device <NUM> includes a locking assembly in the form of a locking hub <NUM> (similar to the device <NUM>) which allows the user to selectively lock the guidewire <NUM> with the device <NUM>. The locking hub <NUM> allows free movement of the guidewire <NUM> when positioned near the case <NUM> (<FIG>) and locks the guidewire <NUM> when the hub is pulled away from the case <NUM> (<FIG>). The hub <NUM> includes an interior cavity with a top surface angled downward towards the case <NUM>. Within the interior cavity is a locking wedge <NUM> which is located within a window <NUM> of a tube <NUM> that exposes the guidewire <NUM>. In the unlocked position of <FIG>, the hub <NUM> restrains the wedge <NUM> but does not press down on the wedge <NUM>, thereby allowing the guidewire <NUM> to slide underneath the wedge <NUM>. In the locked position of <FIG>, the angled interior surface of the hub <NUM> forces the wedge downward against the guidewire <NUM>, preventing the guidewire from movement relative to the device <NUM>. A perspective view of the wedge <NUM> can also be seen in <FIG>.

As seen in <FIG>, the motor <NUM> includes a worm <NUM> that engages a first gear section 156B of shaft <NUM>. A worm 156A of shaft <NUM> engages gearing 148A on the outer surface of tube <NUM>. In this respect, when the motor <NUM> is activated, it ultimately rotates the roller assembly, or tube <NUM>. Thus, the hub <NUM> must be in a slid-out, locked position to cause the guidewire <NUM> to rotate.

As with all motorized embodiments described in this specification, the device <NUM> may also include a microprocessor and memory for storing and executing different rotation sequences (i.e., rotation directions and rotation speeds).

<FIG> and <FIG> illustrate a guidewire manipulation device <NUM> according to yet another embodiment according to the present disclosure. The device <NUM> is generally similar to previously described embodiments, including an outer case <NUM> having an actuation button <NUM> that is coupled to a battery <NUM> and a motor <NUM>. The gear <NUM> of the motor <NUM> is engaged with a gear <NUM> that is also engaged with a geared section <NUM> on wedge tube <NUM>.

A hub <NUM> includes an interior, angled passage that increases in diameter in a distal direction. The wedge tube <NUM> is partially positioned within the hub <NUM>. In the unlocked position of <FIG>, the angled passage of the hub <NUM> complements a distally expanding shape of the wedge tube <NUM>, thereby preventing the wedge tube <NUM> from clamping or providing force on the guidewire <NUM> and thus allowing the guidewire <NUM> to slide and rotate relative to the device <NUM>. In the looked position of <FIG>, the hub <NUM> is moved distally from the case <NUM>, causing the smaller diameter of the interior passage of the hub <NUM> to wedge or clamp on to the expanded distal end of the wedge tube <NUM>. Thus, the wedge lobe <NUM> (preferably composed of a compressible, semi-compressible or deformable material) closes around the guidewire <NUM>, maintaining the position of the guidewire <NUM> relative to the device <NUM> and further allowing rotation of the guidewire <NUM>.

<FIG> illustrates another embodiment of a device <NUM> according to the present disclosure. The device <NUM> is generally similar to the previously described devices. However, the device <NUM> includes a locking assembly in the form of a guidewire lock activated by depressing a trigger <NUM>. In this respect, the user can rotate hub <NUM>, either clockwise or counter clockwise to respectively rotate the guidewire <NUM>.

The device <NUM> is generally similar to the previously described embodiments, including a motor <NUM> powered by a battery <NUM>, a gear <NUM> coupled to an output gear <NUM> of the motor <NUM> and to a geared portion 200B of a wedge tube <NUM> and a case <NUM> to contain the components. The motor <NUM> is controlled by a rocker switch <NUM> that is connected to a first circuit board <NUM> which sends the position of the rocker switch <NUM> to the second circuit board <NUM>. The second circuit board <NUM> includes a microprocessor and memory for executing a plurality of rotation programs. These rotation programs direct the motor <NUM> to make predetermined rotation movements such as in a single direction, exponentially increasing rotational speed, quick rotation to cause vibration or a predetermined series of rotational movements. Thus, more complicated movements can be performed by the user.

The device <NUM> locks on to the guidewire <NUM> when the user releases trigger <NUM> (see <FIG>) and unlocks the guidewire <NUM> when the user depresses trigger <NUM>. The trigger <NUM> moves an outer tubing <NUM> which is biased in a distal direction by a spring <NUM>. The interior passage of the outer tubing <NUM> increases in diameter in a distal direction forming an inverted cone shape. An inner wedge tube <NUM> is positioned within the passage of the outer tubing <NUM> and includes a wedge 200A that increases in size in a distal direction of the device <NUM>. The guidewire <NUM> is located within a passage of the wedge tube <NUM>.

When the trigger <NUM> is released, as in <FIG>, the outer tubing <NUM> is moved distally by the spring <NUM>, causing the smaller diameter region of the inner passage of the outer tubing <NUM> to press against the wedge 200A of wedge tube <NUM>. The wedge <NUM> then compresses around the guidewire <NUM>, locking the guidewire <NUM> in place relative to the device <NUM>. When the trigger <NUM> is depressed, as in <FIG>, a portion of the trigger <NUM> pushes the outer tubing <NUM> in a proximal direction, against the bias of the spring <NUM>. The angled portions of the inner passage of the outer tubing <NUM> move away from the wedge 200a, allowing the inner passage of the wedge tube <NUM> to release the guidewire <NUM>. Thus, the user can selectively lock on to and rotate the guidewire <NUM> (with the roller assembly, including wedge tube <NUM>) by releasing the trigger <NUM> and pressing the actuation button <NUM>.

<FIG> illustrate another embodiment of a guidewire manipulation device <NUM> according to the present disclosure. The device <NUM> is generally similar to the previously described embodiments. Including a battery <NUM> powering a motor <NUM> which drives a wedge tube <NUM> (via a gear <NUM> connected to geared region 224B and output gear <NUM>) and an actuation button <NUM>.

The device <NUM> further includes a locking mechanism assembly that locks the lateral position of the guidewire <NUM>. As seen in <FIG>, when the user releases the trigger <NUM>, the device remains in a locked position, allowing the user to rotate the guidewire <NUM>. As seen in <FIG>, when the user depresses the trigger <NUM>, the device remains in an unlocked position, allowing the user to slide the device <NUM> along the guidewire <NUM> and preventing guidewire rotation.

In the locked position, the trigger <NUM> maintains an outer tube <NUM> in a proximal position, proximally biased by a spring <NUM>. The outer tube includes an inner passage that generally decreases in diameter in a distal direction. The inner surface of the outer tube <NUM> presses against a wedge portion 224A of a wedge tube <NUM>, causing the wedge tube <NUM> to press against and lock onto the guidewire <NUM>.

In the unlocked position, the trigger <NUM> pushes the outer tube <NUM> distally, against the bias of the spring <NUM>. The surface of the inner passage of the outer tube <NUM> moves away from the wedge 224A, releasing the wedge tube <NUM> from the guidewire <NUM>.

The systems and methods disclosed herein further comprise a guidewire manipulation device for selectively imparting motive force (rotational and/or axial/longitudinal (linear) motion) to a guidewire. In use, such a guidewire manipulation device is selectively locked to a guidewire and is activated to impart motive force to maneuver the guidewire to a desired location during an endovascular procedure. The motive force applied to the guidewire is selectively rotational or axial to facilitate moving the guidewire through a vessel and/or penetrating occlusions.

<FIG> illustrates a view of a guidewire manipulation device <NUM> being used on a patient <NUM> according to one embodiment of the present disclosure. In one embodiment, the guidewire manipulation device <NUM> is a handheld device capable of fitting in the palm of a user's hand and being operated using one hand. In one embodiment, the guidewire manipulation device <NUM> is advanced over a guidewire <NUM>, i.e., the guidewire <NUM> passes through a longitudinally oriented passage in the device <NUM>. During an endovascular procedure, the guidewire <NUM> is introduced into a vessel <NUM> (e.g., a femoral artery) of the patient <NUM>. The guidewire manipulation device <NUM> is selectively locked to the guidewire <NUM>. As the guidewire is advanced into the patient, the user operates the manipulation device <NUM> to impart motive force (rotational and/or axial motion) to the guidewire <NUM>, as appropriate.

For example, as a distal end <NUM> of the guidewire <NUM> reaches an angled, curved, stenosed, or occluded region of the vessel <NUM>, the user locks the manipulation device <NUM> to the guidewire and imparts rotational motive force to the guidewire <NUM> (e.g., in a counter-clockwise direction indicated by arrow <NUM>), thereby causing the distal end <NUM> of the guidewire <NUM> to more easily advance through the angled, curved, stenosed, or occluded region of the vessel <NUM>. Once advanced past the region, the device <NUM> is unlocked from the guidewire and the guidewire can be further advanced through the vessel. In another example, the distal end <NUM> of the guidewire <NUM> reaches an obstruction (e.g., an embolism, including, but not limited to a thromboembolism) but is unable to pass the obstruction. The user then locks the guidewire manipulation device <NUM> to the guidewire <NUM> and imparts a vibratory motion (e.g., rapidly oscillating between clockwise and counter-clockwise rotation). Such motion causes the distal end <NUM> of the guidewire <NUM> to pass through the obstruction. In another example, when the distal end <NUM> of the guidewire <NUM> reaches an obstruction, the user locks the guidewire manipulation device <NUM> to the guidewire <NUM> and imparts an axial motion (e.g., a linear movement of the guidewire <NUM>) to create a jackhammer effect. In another embodiment, the user may lock the device <NUM> to the guidewire <NUM> and simultaneously impart both rotational and axial motion to the guidewire <NUM>. In another embodiment of the present disclosure, a sequence of predefined guidewire manipulations (i.e., a pattern) may be produced using a computer program for controlling the motion as described in detail below. Various motive patterns to be selectively used in various surgical situations can be selected from memory and applied to the guidewire.

<FIG> depicts a schematic block diagram of one embodiment of a guidewire manipulation device <NUM>. The guidewire manipulation device <NUM> defines an axially longitudinal passage <NUM> through which the guidewire <NUM> is threaded during use. The guidewire manipulation device <NUM> comprises a housing <NUM>, an actuator <NUM>, and a chuck <NUM>. The chuck <NUM> comprises a guidewire locking mechanism <NUM>. During use, the chuck <NUM> is locked to the guidewire <NUM> using the looking mechanism <NUM>. Once locked, the actuator selectively imparts motive force (rotational motion and/or axial motion) to the guidewire <NUM>.

<FIG> depicts a vertical cross-sectional view of one embodiment of a guidewire manipulation device <NUM>. In this embodiment, the actuator <NUM> of <FIG> is divided into a rotary actuator 2206A and an axial actuator 2206B such that the device may selectively apply to the guidewire: no motive force, rotary motive force or rotary and axial motive force.

Device <NUM> comprises a housing <NUM> typically formed into halves that are glued, bonded, screwed, or otherwise affixed to each other to form an enclosure. Within the housing <NUM> are defined slots <NUM> wherein are retained bushings 302A and 302B. The bushings 302A and 302B support an axle <NUM> on its outer surface <NUM>. The axle <NUM> defines the passage <NUM> extending axially through the axle <NUM>. When in use, the guidewire <NUM> is threaded through the passage <NUM>.

The rotary actuator 2206A comprises the axle <NUM>, a motor <NUM>, a drive assembly <NUM>, a controller <NUM>, and a control switch <NUM>. The drive assembly <NUM> couples rotational motion of the motor <NUM> to the axle <NUM> using a plurality of gears, further described with respect to <FIG> below. In one embodiment of the present disclosure, the controller <NUM> is simply one or more batteries that are coupled to the motor <NUM> via the control switch <NUM>. In such an embodiment, the control switch <NUM> may simply apply a voltage from the one or more batteries to the motor <NUM> to cause the motor <NUM> to rotate. In its simplest form, the control switch <NUM> is a simple single-pole, single-throw (SPST), momentary contact switch. In other embodiments, the controller <NUM> comprises a programmable microcontroller as described with respect to <FIG> below. In other embodiments, the switch <NUM> may apply voltage to cause the motor <NUM> to selectively rotate clockwise or counter-clockwise. The control switch <NUM> is generally mounted to be exposed to the exterior of the housing <NUM> and facilitate manipulation by one hand of a user (e.g., a thumb activated push-button or slide switch.

The axle <NUM> is coupled to a chuck <NUM>. In one embodiment, the chuck <NUM> comprises a coupler <NUM>, a hub <NUM> and a wedge <NUM>. The coupler <NUM> and the axle <NUM> have splined mating surfaces <NUM> for coupling the rotational motion of the axle <NUM> to the chuck <NUM>, while allowing the coupler <NUM> to move in an axial direction. The hub <NUM> is threaded onto the coupler <NUM> at surface <NUM>. The wedge <NUM> is located in a window <NUM> defined by the coupler <NUM>. The hub <NUM> retains the wedge <NUM> within the window <NUM>. In a disengaged (unlocked) position, the hub <NUM> does not impart pressure to the wedge <NUM> thereby allowing the guidewire <NUM> to slide freely beneath the wedge <NUM> and through the passage <NUM>. To lock (engage) the guidewire into the lock mechanism <NUM>, the hub <NUM> is rotated relative to the coupler <NUM> such that the angled surface <NUM> of the hub <NUM> interacts with the top surface <NUM> of the wedge <NUM>. As the hub <NUM> is moved relative to the coupler <NUM> via the mating threaded surfaces <NUM>, the wedge <NUM> is forced against the guidewire <NUM>. Consequently, the guidewire <NUM> is captured between the wedge <NUM> and the coupler <NUM> and thereby locked into the chuck <NUM>. Once locked, any motion of the chuck <NUM> (e.g., rotational and/or longitudinal) is imparted as motive force to the guidewire <NUM>.

Other embodiments of the present disclosure utilize other forms of chucks. In a broad sense, any mechanism that can be used to selectively lock the guidewire to a source of motive force may be used. Other forms of chucks having multiple jaws or compressive slotted cylinders are applicable.

The coupler <NUM> comprises a spring seat <NUM> supporting a first end of a spring <NUM>. The second end of spring <NUM> rests against a flange <NUM> that extends from the inner surface of the housing <NUM>. The spring <NUM> is one embodiment of a resilient member that biases the coupler <NUM> inwardly toward the axle <NUM>. The coupler <NUM> further comprises a flange <NUM> that extends radially from the outer surface of the coupler <NUM>. The flange <NUM> is positioned along the coupler <NUM> to limit the amount of axial movement that can be imparted to the chuck <NUM>. The flange <NUM> abuts the housing flange <NUM>. As such, the spring <NUM> biases the coupler <NUM> to maintain contact between the flange <NUM> and the flange <NUM>.

To impart axial (longitudinal) motion to the chuck <NUM>, the bottom surface <NUM> of the hub <NUM> is dimpled. The surface <NUM> interacts with a protrusion <NUM> extending from the exterior surface of the housing <NUM> proximate the surface <NUM> of the hub <NUM>. Depending on the position of the hub <NUM> relative to the coupler <NUM>, the spring <NUM> insures that the protrusion <NUM> interacts with the dimpled surface <NUM>. Upon locking the chuck <NUM> to the guidewire <NUM> and imparting rotation to the chuck <NUM>, the guidewire <NUM> moves in an axial direction as indicated by arrow <NUM>. To disengage the axial motive force, the hub <NUM> is rotated relative to the coupler <NUM> along the threads <NUM> to decouple the protrusion <NUM> from the surface <NUM>. In this manner, the locking mechanism <NUM> retains the guidewire <NUM> such that rotational motion of the axle <NUM> is imparted to the guidewire <NUM> without imparting axial motion. In this embodiment, the axial motion actuator 2206B comprises the hub <NUM>, spring <NUM>, coupler <NUM> and the housing <NUM>.

<FIG> depicts a cross sectional view of the drive assembly <NUM> of the rotary actuator 2206A taken along line <NUM>-<NUM> of <FIG> in accordance with one embodiment of the present disclosure. The drive assembly <NUM> comprises a motor gear <NUM>, an intermediary gear <NUM> and an axle gear <NUM>. The motor <NUM> of <FIG> is coupled to the motor gear <NUM> to impart rotational motion to the motor gear <NUM>. In one embodiment, the axle gear <NUM> is formed as an integral part of this surface of the axle <NUM> of <FIG>. The intermediary gear <NUM> is designed to provide a gear ratio between the motor gear <NUM> and axle gear <NUM>. The diameters and the number of teeth of each gear is considered to be a design choice that will define the speed of rotational motion of the guidewire <NUM> as well as the oscillatory speed of the axial motion.

In other embodiments, the motor <NUM> of <FIG> may be coupled to the axle via other forms of drive assemblies, e.g., direct drive, worm gear, and/or the like. The specific motor and drive assembly characteristics are considered a design choice to develop specific guidewire rotation speed and torque. In some embodiments, the drive assembly may be adjustable to facilitate creating specific speed and torque profiles or adjustments. One form of adjustments may be facilitated by the use of a stepper motor that can be controlled with a pulse width modulated signal produced by the controller, as discussed below.

An alternative embodiment for imparting rotary motive force in selectable directions uses a gear train comprising two larger diameter spur gears mounted on a common shaft that is driven constantly in one direction by an electric motor. Each of the two spur gears has a section of its teeth, something over <NUM>/<NUM> its total number, removed. The removed sections of teeth are positioned such that only one or the other of two additional smaller spur gears, each located to be driven by one of these common shaft gears, will be driven at a time. The two smaller spur gears are then used one at a time to drive the gear on the axle, but the positioning of one additional gear between just one of these driving gears and the axle gear results in the rotational direction of the axle being reversed when that set is driving the axle gear.

Another embodiment, if only forward and reverse is required without a near constant rotational speed in either direction, has the spur gear on the axle driven by a pivoted <NUM>/<NUM> pie-shaped plate. The toothed curved section opposite the pivot near the tip would be configured to have the correct pitch radius to mesh with the axle spur gear. This pivoted gear section plate would have, running upwards from its pivot, a slot in its face in which a pin, mounted off-center and a disc, could slide up and down freely. As an electric motor turns this disc in a constant direction, it would cause the pivoted plate to wobble back and forth so that its gear section drives the axle spur gear in one direction and then in the reverse direction.

<FIG> depicts a perspective view of the hub <NUM> in accordance with one embodiment of the present disclosure. The hub <NUM> comprises a surface <NUM> having a plurality of dimples <NUM> and spaces <NUM> between the dimples <NUM>. The hub <NUM> further comprises a threaded interior surface <NUM>. The threaded interior surface <NUM> is adapted to interact with a threaded exterior surface of the coupler <NUM> to adjust the position of the hub relative to the coupler <NUM> and the wedge <NUM>. The dimples <NUM> and the spaces <NUM> between the dimples <NUM> are adapted to interact with the protrusion <NUM> to impart axial motion to the chuck <NUM>. The spacing of the dimples and the speed of the motor control the oscillation rate of the axial motion. Furthermore, the depth of the dimples <NUM> relative to the spaces <NUM> on the surface <NUM> controls the travel distance of the axial motion.

<FIG> depicts a block diagram of the controller <NUM> in accordance with one embodiment of the present disclosure. The controller <NUM> comprises a microcontroller <NUM>, support circuits <NUM>, memory <NUM> and a power supply <NUM>. The microcontroller <NUM> may be one or more of many commercially available microcontrollers, microprocessors, application specific integrated circuits (ASIC), and the like. The support circuits <NUM> comprise well known circuits that facilitate the operation of the microcontroller <NUM> including, but not limited to, clock circuits, cache, power supplies, input/output circuits, indicators, sensors, and/or the like. In one embodiment, the power supply <NUM> comprises one or more batteries. In other embodiments, the power supply <NUM> may comprise an AC to DC converter to allow the guidewire manipulation device to be plugged into a wall socket. In further embodiments, the power supply <NUM> may comprise one or more batteries and a charging circuit for the batteries may be inductively coupled to a base charger.

The memory <NUM> may be any form of memory device used to store digital instructions for the microcontroller <NUM> as well as data. In one embodiment, the memory <NUM> is random access memory or read only memory comprising control code <NUM> (e.g., computer readable instructions) that are used to control the actuator <NUM> to impart motion to the guidewire <NUM>. The programs utilized by the microcontroller <NUM> to control the actuator <NUM> are generally controlled by the control switch <NUM> and/or another input device.

In one embodiment of the present disclosure, the motor <NUM> is a stepper motor that is controlled using, for example, a pulse width modulated signal produced by the controller <NUM> to impart specific torque and/or speed profiles to the motor <NUM>. In some embodiments, predefined programs can be generated and selected through manipulation of the switch <NUM> to enable a user to overcome specific types of obstructions within the path of the guidewire. For example, if a surgeon encounters a specific type of embolism, a specific program defining the motion of the guidewire to overcome the obstruction can be selected and implemented. Various programs can be generated through empirical study of guidewire utilization in endovascular procedures. To select a particular motion pattern, the switch may be a slide switch having a plurality of selectable positions, where each position corresponds to a different motion pattern.

<FIG> depicts a vertical cross-sectional view of a guidewire manipulation device <NUM> according to an alternative embodiment of the present disclosure. In this embodiment, the use of axial motion is selected through manipulation of a mechanical switch <NUM>. As with the prior embodiment, this embodiment selectively imparts to a guidewire: no motive force, rotary motive force, or rotary and axial motive force. The device <NUM> comprises a rotational actuator 2206A as described above with respect to <FIG>. In this embodiment, a coupler <NUM> comprises a spring seat <NUM>, a dimpled flange <NUM> and a switch stop <NUM>. A slidable switch <NUM> comprises an extension <NUM> that interacts with a switch seat <NUM>. The switch seat <NUM> and the spring seat <NUM> define a space <NUM> that captures the switch extension <NUM>. Manipulation of the switch <NUM> causes the coupler <NUM> to move axially along the surface that mates with the axle <NUM>. A spring <NUM> is positioned between the spring seat <NUM> and the housing flange <NUM>. The spring <NUM> biases the coupler <NUM> inwardly toward the axle <NUM>. The dimpled flange <NUM> radially extends from the coupler <NUM>. One surface of the dimpled flange <NUM> abuts the housing flange <NUM> to limit the distance the coupler <NUM> moves in an axial direction. The dimpled flange <NUM> has a surface aligned with a dimpled surface <NUM> of the housing <NUM>. When the guidewire <NUM> is locked to the chuck <NUM> and the rotational actuator 2206A is activated, the guidewire <NUM> rotates without any axial movement. As described further with respect to <FIG> below, when the switch <NUM> is moved forward to cause the dimpled surface of flange <NUM> to engage the dimpled surface <NUM>, the guidewire <NUM> axial motive force is imparted to the guidewire <NUM>.

<FIG> depicts a partial perspective view of the coupler <NUM> in accordance with one embodiment of the present disclosure. The coupler <NUM> has an aperture <NUM> through which the guidewire <NUM> is threaded. The dimpled flange <NUM> comprises a radially extending flange <NUM> having a plurality of dimples <NUM> formed in the surface <NUM>. In one embodiment, the dimples <NUM> are formed as a sequence of wedges. In other embodiments, to cause axial motion of the chuck when the coupler <NUM> is rotated, the surface <NUM> of the flange <NUM> is varied such that interaction with a corresponding surface causes axial movement of the coupler <NUM>.

<FIG> depicts a cross-sectional view of the housing <NUM> taken along line <NUM>-<NUM> in <FIG>. In one embodiment, the surface <NUM> comprises corresponding protrusions shaped to interact with the dimples <NUM> in the surface <NUM> of the coupler <NUM>. In another embodiment, the surface <NUM> may comprise complementary wedges <NUM> to the surface <NUM> of the coupler <NUM>. The shape of the wedges <NUM> defines, in part, the distance travelled, the rate of acceleration of the guidewire <NUM>, and the speed of the oscillation of the guidewire <NUM>.

<FIG> depicts an embodiment of the guidewire manipulation device <NUM> of <FIG> where the dimpled flange <NUM> has been engaged the protrusion surface <NUM>. In this manner, the switch <NUM> has moved the coupler <NUM> forward to facilitate engagement of the surfaces <NUM> and <NUM>. When the chuck <NUM> locks to the guidewire <NUM> and the rotary actuator is activated, the guidewire <NUM> rotates as shown in arrow <NUM> and axially oscillates as represented by arrow <NUM>.

<FIG> depicts a vertical cross-sectional view of a portion of a guidewire manipulation device <NUM>. Device <NUM> comprises an axial actuator 2206B that can be selectively utilized without imparting rotational motion of the guidewire. As such, with this embodiment, the device <NUM> selectively imparts to the guide wire: no motive force, rotary motive force, axial motive force, or axial and rotary motive force.

In one embodiment, the device <NUM> comprises a linear actuator <NUM> coupled to a shaft <NUM> that interacts with a fulcrum <NUM>. The linear actuator <NUM> imparts linear motion to one portion of the fulcrum <NUM>. The fulcrum is mounted upon a pivot point <NUM> such that the fulcrum <NUM> rotates about the pivot point <NUM> as a linear motive force is applied to the fulcrum <NUM>. A second end of the fulcrum <NUM> interacts with a coupler <NUM>. The coupler <NUM>, as with prior embodiments, has a splined surface that interacts with the axle <NUM> to impart rotational motion to the coupler <NUM>, as needed. The coupler <NUM> comprises a spring seat <NUM>. A spring <NUM> is positioned between the housing <NUM> and the spring seat <NUM> to bias the coupler <NUM> toward the axle <NUM>. The fulcrum <NUM> couples to the spring seat <NUM> such that motion of the fulcrum <NUM> axially moves the coupler <NUM>. In this manner, without any rotational motion the linear actuator <NUM> imparts axial motion to the coupler <NUM> and to guidewire <NUM> locked in the chuck <NUM>.

In one embodiment, the linear actuator <NUM> may be a solenoid, piezoelectric actuator, linear motor, rotary motor and ball screw or rack/pinion, and/or the like. In another embodiment, a hammer-drill type assembly may be used to impart axial force to the guidewire.

The controller <NUM> in a manner similar to that described for controlling the motor <NUM> of <FIG> may control the linear actuator <NUM>.

<FIG> shows an open distal end <NUM> of an aspiration lumen <NUM> of an aspiration catheter <NUM> for aspirating thrombus within a blood vessel <NUM>. A skive <NUM> may be formed in a polymer jacket <NUM> of the aspiration catheter <NUM>, to aid entry of a thrombus <NUM> that is aspirated into the aspiration lumen <NUM> (in the direction of arrow <NUM>) by the combination of the vacuum created by a vacuum source (e.g., VacLok® Syringe, vacuum bottle) and the injection of fluid into the distal end of the aspiration lumen <NUM>, as described below. The skive <NUM> also minimizes the chances of the open distal end <NUM> being sucked against a blood vessel wall <NUM>. A distal supply tube <NUM> of the aspiration catheter <NUM> has a closed distal end <NUM>. For example, it may be occluded during manufacture using adhesive, epoxy, hot melt adhesive or an interference member, such as a metallic or polymeric plug. However, in some embodiments, the aspiration catheter <NUM> may have a blunt or non-angled tip, instead of the skive <NUM>. Alternatively, the distal supply tube <NUM> may be closed off by melting a portion of it. The distal supply tube <NUM> has a lumen <NUM> extending its length and an orifice <NUM> formed through its wall <NUM> at a location adjacent and proximal to the closed distal end <NUM>. The orifice <NUM> may have a diameter between about <NUM> (<NUM> inches) and about <NUM> (<NUM> inches), or about <NUM> (<NUM> inches). The inner diameter of the distal supply tube <NUM> may be between about <NUM> (<NUM> inches) and about <NUM> (<NUM> inches), or between about <NUM> (<NUM> inches and about <NUM> (<NUM> inches) or about <NUM> (<NUM> inches). The lumen <NUM> of the distal supply tube <NUM> is a continuation of an overall flow path emanating from a fluid source (e.g., saline bag, saline bottle) including an extension tubing (not shown). In some embodiments, the lumen <NUM> of the distal supply tube <NUM> may taper, for example, from an inner diameter of about <NUM> (<NUM> inches) at a proximal portion to an inner diameter of about <NUM> (<NUM> inches) at a distal portion. In some embodiments, the equivalent of a taper may be achieved by bonding different diameter tubing to each other, resulting in a stepped-down tubing inner diameter. In some embodiments, different diameter tapered tubing may be bonded to each other, for a combination of tapering and step-down of diameter. An output pressure wave (for example, of saline injected via a pump) causes a liquid injectate to flow through the flow path, including a distal supply tube <NUM> (arrow <NUM>), and causes a fluid jet <NUM> to exit the orifice <NUM> at a high velocity. The fluid jet <NUM> serves to macerate thrombus <NUM> that is sucked into the aspiration lumen <NUM>, and also can serve to dilute the thrombus. This maceration and dilution assures that there is continuous flow through the aspiration lumen <NUM> so that it will not clog. The fluid jet <NUM> is configured to be contained within the aspiration lumen <NUM>, and to not exit into a blood vessel or other body lumen. A guidewire tube <NUM> having a distal end <NUM> and a proximal end <NUM> and having a distal port <NUM> and a proximal port <NUM> is secured to the aspiration catheter <NUM> with attachment materials <NUM>. Though the guidewire tube <NUM> of <FIG> is shown having a length that is shorter than the length of the aspiration catheter <NUM> (sometimes referred to as a rapid exchange catheter), in other embodiments, the guidewire tube <NUM> may extend substantially the entire length of the aspiration catheter <NUM>. In some embodiments, the aspiration catheter <NUM> may have a length of between <NUM> and <NUM>, and the guidewire tube <NUM> may have a length of <NUM> or less. In some embodiments, the guidewire tube <NUM> may be a length of <NUM> or less. In some embodiments, the guidewire tube may have a length of <NUM> or less. In some embodiments the guidewire tube may have a length of <NUM> or less. In some embodiments, the guidewire tube may have a length of between about <NUM> and about <NUM>. The guidewire tube <NUM> may be located adjacent (i.e., lateral) to the aspiration lumen <NUM>, or may be located co-axially within the aspiration lumen <NUM>. An additional guidewire <NUM> may be used along with any aspiration catheter (including, for example, the aspiration catheter <NUM>) to facilitate the movement of aspirated or macerated thrombus through a catheter lumen, for example, through the aspiration lumen <NUM> of the aspiration catheter <NUM>. The guidewire <NUM> is secured at its proximal end <NUM> (<FIG>) to any of the embodiments of the guidewire manipulation device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. A distal end <NUM> includes a straight portion <NUM>. In embodiments not claimed, the distal end may include a curved portion <NUM>, or a combination of a straight portion <NUM> and a curved portion <NUM>. The guidewire <NUM> may include a curved portion <NUM> which is not located at the very distal end <NUM>. The curved portion <NUM>, <NUM> may comprise a single arc or multiple arcs, but may generally comprise any non-straight pattern. The one or more arcs may be contained within a plane, or they may be three-dimensional. The curved portion <NUM>, <NUM> may comprise a helix, such as a single diameter helix or a tapering diameter helix. The tapering diameter helix may taper such that the diameter increases as it extends distally, or such that the diameter decreases as it extends distally. In some cases, a fully straight guidewire <NUM> may be used.

In <FIG>, either the straight portion <NUM> of the distal end <NUM> or the curved portion <NUM> of the distal end <NUM> (or both in combination) may be placed adjacent or within the thrombus <NUM> by inserting the guidewire <NUM> through the aspiration lumen <NUM> of the aspiration catheter <NUM>, and then operating the guidewire manipulation device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> to rotate, longitudinally cycle, or otherwise move the guidewire <NUM>. The movement caused at the distal end <NUM> of the guidewire <NUM> serves to help to break up or macerate the thrombus <NUM>, and also help to move the partially or completely macerated thrombus <NUM> (or a portion thereof) towards the aspiration catheter <NUM> and particularly towards the open distal end <NUM> of the aspiration lumen <NUM> of the aspiration catheter <NUM>. The curved portion <NUM> within the aspiration lumen <NUM> of the aspiration catheter <NUM> also serves to facilitate the movement of the partially or completely macerated thrombus <NUM> (or a portion thereof) through the aspiration lumen <NUM> of the aspiration catheter <NUM>, towards a proximal end of the aspiration lumen <NUM>. The curved portion <NUM> may also serve to help center the guidewire <NUM> within the aspiration lumen <NUM> or to stabilize the guidewire <NUM> as it is rotated or longitudinally moved by the guidewire manipulation device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. In some cases, the guidewire <NUM> may be slowly pulled proximally during the aspiration of the thrombus <NUM>, so that the curved portion <NUM> helps to translate portions of thrombus. In some embodiments, the curved portion <NUM> may be replaced by a straight portion. For example, a guidewire may comprise an outer coil extending along its longitudinal axis, which comprise external contours that will serve to macerate or translate a portion of thrombus. The guidewire manipulation device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be operated such that the guidewire <NUM> is rotated in a direction such that the curved portion <NUM> (or the straight portion of helical coil) rotates in a direction that preferentially moves the portion of thrombus proximally in the aspiration lumen, in a similar action to an impeller or Archimedes screw. If the aspiration lumen <NUM> of the aspiration catheter <NUM> becomes clogged with thrombus or other embolus, the guidewire manipulation device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be attached to a guidewire <NUM> that is already in place (i.e., through a guidewire lumen) to guide the catheter, and then the guidewire manipulation device may be activated to move (rotate, longitudinally translate, etc.) the guidewire <NUM> to help dislodge the thrombus or other embolus so that it can be fully aspirated/evacuated and removed from the aspiration lumen <NUM>, thus eliminating the clog. The guidewire <NUM> or other elongate medical devices may be fabricated from a number of different biocompatible materials, including, but not limited to stainless steels or shape-memory alloys such as nickel-titanium alloys (Nitinol).

In <FIG>, both the aspiration catheter <NUM> and the guidewire <NUM> may be inserted (separately or together) through a delivery catheter, such as a coronary guiding catheter. <FIG> illustrates the aspiration catheter <NUM> and a guidewire <NUM> inserted through a delivery catheter <NUM>, such as a coronary guiding catheter, but in this case, the guidewire <NUM> is radially adjacent the aspiration catheter, within an annulus between the interior of the delivery catheter <NUM> and the exterior of the aspiration catheter <NUM>. Thus, the guidewire <NUM> may be moved or manipulated by the guidewire manipulation device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> such that the distal end <NUM> aids the maceration or movement of the thrombus <NUM> not only into the aspiration lumen <NUM> of the aspiration catheter <NUM>, but also into the lumen <NUM> of the delivery catheter <NUM>. The curved portion <NUM> (or a straight portion) is configured to aid the movement of the thrombus <NUM> (or a portion thereof) through the lumen <NUM> of the delivery catheter <NUM>. In some cases, the guidewire <NUM> may be slowly pulled proximally during the aspiration of the thrombus <NUM>, so that the curved portion <NUM> helps to translate portions of thrombus <NUM>. In other embodiments, two guidewires <NUM> and two guidewire manipulation devices <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be used, in a combination of the methods of <FIG>. The aspiration catheters described herein may include any standard aspiration catheter having one or more aspiration lumens. Aspiration catheters used herein may include the ACE™ or INDIGO® catheters produced by Penumbra, Inc. of Alameda, CA, USA.

Aspiration catheters and aspiration systems may include those described in <CIT>.

<FIG> illustrates a system for treating thrombus <NUM>. The system for treating thrombus <NUM> includes a delivery catheter <NUM> having a lumen <NUM> through which an aspiration catheter <NUM> is placed. A guidewire <NUM> may be inserted either through the lumen <NUM> of the delivery catheter <NUM>, or (as shown in <FIG>) through a lumen of the aspiration catheter <NUM>, for example, through the aspiration lumen <NUM> of the aspiration catheter <NUM>. The guidewire <NUM> is configured to be manipulated (rotationally and/or longitudinally) by a guidewire manipulation device <NUM> having a housing <NUM> and a handle <NUM>. The guidewire manipulation device <NUM> may include any of the embodiments described herein, or may include embodiments of guidewire manipulation devices such as those disclosed in co-pending <CIT> and entitled "System and Method for Manipulating an Elongate Medical Device. " The delivery catheter <NUM> has a proximal end <NUM> and a distal end <NUM>, with the proximal end <NUM> coupled to a y-connector <NUM> by a luer connection <NUM>. The luer connection <NUM> may include in some embodiments a female luer attached to the proximal end <NUM> of the delivery catheter <NUM> and a male luer at the distal end of the y-connector <NUM>. A hemostasis valve <NUM> at the proximal end of the y-connector <NUM> is configured to seal around a shaft <NUM> of the aspiration catheter <NUM>, and may include a Touhy-Borst, a spring-loaded seal, a duckbill seal, or other seals. A connector <NUM> is attached to the proximal end <NUM> of the aspiration catheter <NUM>. The connector <NUM> includes a central bore <NUM> which is in fluid communication with the aspiration lumen <NUM>, and which terminates in a connector <NUM> (for example, a female luer connector). In embodiments wherein the aspiration catheter <NUM> comprises a forced aspiration catheter, a port <NUM> is in fluid communication with the lumen <NUM> of the distal supply tube <NUM> (<FIG>). Thus the port <NUM> may be configured to be coupled to a source of pressurized fluid <NUM> (e.g., normal saline). The connector <NUM> is configured to be coupled to a connector <NUM> at the distal end of a y-connector <NUM>. The connector <NUM> may comprise a male luer. The y-connector <NUM> includes a hemostasis valve <NUM> (Touhy-Borst, spring-loaded seal, etc.) and a sideport <NUM>. The hemostasis valve <NUM> is configured to seal around the guidewire <NUM>. The sideport <NUM> of the y-connector <NUM> is configured to be coupled to a vacuum source <NUM>. The sideport <NUM> of y-connector <NUM> may additionally be configured to be coupled to a vacuum source <NUM>, and/or may be used for injections of fluids, such as contrast media.

The aspiration catheter <NUM> includes an open distal end <NUM>, which may include a skive <NUM>. The guidewire <NUM> is shown in <FIG> having a distal end <NUM> which includes a curved portion <NUM> and a straight portion <NUM>, though other distal configurations are also contemplated, including curved only or straight only. The guidewire <NUM> is shown extending through the aspiration lumen <NUM> of the aspiration catheter <NUM> and proximally through the connector <NUM> and through the y-connector <NUM>. The guidewire <NUM> may be secured at its proximal end <NUM> to a rotatable chuck <NUM>, which is rotatably carried by the guidewire manipulation device <NUM>. The chuck <NUM> may be manipulated to selectively grip and ungrip (engage and unengage, lock and unlock, etc.) the guidewire <NUM> via a collet, or any equivalent means. The guidewire manipulation device <NUM> is configured to be supported by the hand of a user, and includes the handle <NUM> which has one or more controls <NUM>. The handle <NUM> may extend in a generally perpendicular direction from the axis of the guidewire <NUM> as it extends through the housing <NUM>, and may angle towards a distal end <NUM> of the housing <NUM> (as shown in <FIG>) in a reverse gun handle grip. Alternatively, the handle <NUM> may have a standard gun handle grip (see <FIG>), and thus may angle towards a proximal end <NUM> of the housing <NUM>. The controls <NUM> are shown in <FIG> carried on a distally-facing surface <NUM> of the handle <NUM>, and may be configured in this embodiment to be operated by one or more finger of the hand of the user, which may include non-thumb fingers. The controls <NUM> may include an activation button <NUM> which is configured to turn power on an off, for example, to power a motor (not shown) which is configured to rotate and/or longitudinally move the guidewire <NUM>. A control knob <NUM> may be configured to increase or decrease a rotation speed (e.g., of the motor) or to select a plurality of different manipulation routines. The manipulation routines may be stored within memory that is carried within the guidewire manipulation device <NUM>, for example, on a circuit board. The circuit board may include a controller, as described in relation to the other embodiments herein. An exemplary manipulation routine may include rotating the guidewire <NUM> in a first rotational direction eight rotations, and then rotating the guidewire <NUM> in a second, opposite, rotational direction eight rotations. Another manipulation routine may include rotating continuously in a single direction. Another manipulation routine may include rotating continuously in one direction while repeatedly translating the guidewire <NUM> distally and proximally (longitudinal cycling). Alternatively, the controls <NUM> may be carried on a proximally-facing surface <NUM> of the handle <NUM>, and may be configured to be operated primarily by the thumb of the hand of the user. The motor may be connected to the chuck <NUM> directly, or by other drive elements, including gearing, which may be used to change speeds, torques, or rotational directions. The drive elements may include those described in relation to any of the embodiments disclosed herein. In use, the vacuum source <NUM> may be coupled to the sideport <NUM> of the y-connector <NUM>, and thrombus may thus be aspirated through the aspiration lumen <NUM> of the aspiration catheter <NUM>. The vacuum source <NUM> may comprise a syringe, a vacuum chamber, or a vacuum pump. Syringes with lockable plungers, for example syringes having volumes of between about <NUM> and about <NUM>, may be used as the vacuum source. While performing an aspiration procedure, the user may simultaneously or sequentially operate the guidewire manipulation device <NUM> to rotate and/or longitudinally move the guidewire <NUM>, in order to aid the maceration of the thrombus and/or the movement of the thrombus or pieces of the thrombus through the aspiration lumen <NUM>.

<FIG> illustrates a system for treating thrombus <NUM>. The system for treating thrombus <NUM> includes a sheath <NUM> having a lumen <NUM> passing therethrough through which a microcatheter <NUM> is placed. A guidewire <NUM> may be inserted a lumen <NUM> of the microcatheter <NUM>. The guidewire <NUM> is configured to be manipulated (rotationally and/or longitudinally) by a guidewire manipulation device <NUM> having a housing <NUM> and a handle <NUM>. The guidewire manipulation device <NUM> may include any of the embodiments described herein, or may include embodiments of guidewire manipulation devices such as those disclosed in co-pending <CIT> and entitled "System and Method for Manipulating an Elongate Medical Device. " The housing <NUM> has a proximal end <NUM> and a distal end <NUM> and the handle <NUM> extends in a substantially radial direction from the guidewire axis of the housing <NUM>. Controls <NUM> are carried by a proximally-facing surface <NUM>, and include an activation button <NUM> and a control knob <NUM>, which may be configured similar to the activation button <NUM> and the control knob <NUM> of the guidewire manipulation device <NUM> of the embodiment of <FIG>. The user's hand is configured to grip the standard gun handle grip of the handle <NUM> by wrapping around the distally-facing surface <NUM>. The handle <NUM> is depicted in <FIG> angling toward the proximal end <NUM> of the housing <NUM>. The user may operate the controls <NUM> using the user's thumb, or a combination of the user's thumb and one of the non-thumb fingers of the user's hand. A chuck <NUM> is carried by the guidewire manipulation device <NUM> adjacent the proximal end <NUM> of the housing <NUM> and is configured to rotate and/or longitudinally move the guidewire <NUM> in a similar manner to the chuck <NUM> of <FIG>. However, the guidewire <NUM> is configured to pass through the housing <NUM> and a proximal end <NUM> of the guidewire <NUM> is configured to be secured to the chuck <NUM>. The guidewire manipulation device <NUM> includes a locking element <NUM> carried adjacent the distal end <NUM> of the housing <NUM> which is connectable to a connector <NUM> which is coupled to a proximal end <NUM> of the microcatheter <NUM>. The locking element <NUM> and the connector <NUM> comprise male and female luer locks, or may comprise other types of locking connections which secure the connector <NUM> with respect to the guidewire manipulation device <NUM>. When the locking element <NUM> and the connector <NUM> are secured to each other, relative rotational and/or longitudinal motion between the guidewire manipulation device <NUM> and the connector <NUM> are inhibited. The sheath <NUM> includes a proximal end <NUM> and a distal end <NUM>, and may include a proximal internal seal <NUM>, and a sideport <NUM> having a luer <NUM>. In use, the user may operate the guidewire manipulation device <NUM> (for example, by holding the handle <NUM> and pressing the activation button <NUM>) while also moving pushing or pulling the microcatheter <NUM> within the lumen <NUM> of the sheath <NUM>. Thrombus may be macerated by the distal end <NUM> of the guidewire <NUM>. If desired, the thrombus may be aspirated through the lumen <NUM> of the sheath <NUM>, by applying a vacuum (e.g., attaching a vacuum source, not shown) to the sideport <NUM> of the sheath <NUM>. The sheath <NUM> may also be moved proximally or distally so that the distal end <NUM> of the sheath approaches the thrombus or portions of thrombus or blood to be aspirated. If desired, the locking element <NUM> of the guidewire manipulation device <NUM> may be detached from the connector <NUM> of the microcatheter <NUM>, and a vacuum source (not shown) may be attached to the connector <NUM> in order to aspirate thrombus or blood through the lumen <NUM> of the microcatheter <NUM>.

<FIG> illustrates an aspiration catheter <NUM> within a blood vessel <NUM> having a blood vessel wall <NUM>. The aspiration catheter <NUM> has an aspiration lumen <NUM> which is configured for aspirating thrombus <NUM> and also for placement of a guidewire <NUM> which is configured to track the aspiration catheter <NUM> through the vasculature of a patient. A distal supply tube <NUM> having a lumen <NUM> is configured for injecting pressurized fluid, such as saline. The pressurized fluid is injected through the lumen <NUM> and out an orifice <NUM> into the aspiration lumen <NUM>. The orifice is located at the extreme distal end of the distal supply tube <NUM>. The output of the pressurized fluid through the orifice <NUM> may comprise a jet <NUM>. Thrombus <NUM> is aspirated into the aspiration lumen <NUM>. In some embodiments, the jet <NUM> macerates the thrombus <NUM> as it passes by the jet <NUM>. The guidewire <NUM> may be attached to the guidewire manipulation device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and moved by the guidewire manipulation device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> in one or more patterns including rotation motion <NUM> and/or longitudinal motion <NUM>. Either or both of these motions may be imparted on the guidewire <NUM> to conjunctively aid the maceration of the thrombus <NUM>, and/or to aid in the transport of the thrombus <NUM> from distal to proximal through the aspiration lumen <NUM>. The rotational motion <NUM> may include clockwise only, counter-clockwise only, or a combination of clockwise and counter-clockwise, for example back and forth rotational oscillation as described herein. The longitudinal motion <NUM> may be movement imparted directly on the guidewire <NUM> by the operation of the guidewire manipulation device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or may be manually applied by the user by moving the guidewire manipulation device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> back and forth (distally and proximally). In some cases, the guidewire manipulation device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be gradually pulled while the guidewire <NUM> is rotated by the guidewire manipulation device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. In some cases, the handle of the guidewire manipulation device can be cyclically moved distally and proximally while generally pulling the guidewire manipulation device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> proximally. For example, one cm distally, two cm proximally, one cm distally, two cm proximally, etc. In some embodiments, the aspiration catheter <NUM> may consist only of a single lumen for aspiration and guidewire placement, without any forced injection (i.e., no distal supply tube <NUM>). In some embodiments, the manipulation of the guidewire <NUM> by the guidewire manipulation device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> performs a similar function to a "separator device" as is used with the ACE™ or INDIGO® aspiration catheters produced by Penumbra, Inc. of Alameda, CA, USA. The "separator device" is a guidewire type device with a ball or football-shaped portion at its tip that extends from an aspiration lumen and is pulled against the distal port of the aspiration lumen to help disrupt or macerate the thrombus/clot.

A variety of different elongate medical devices may be rotated, longitudinally moved, or otherwise manipulated by the embodiments of the guidewire manipulation device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> described herein, including embodiments of the elongated medical instrument and the macerator which are disclosed in <CIT>.

In one embodiment a manipulation device includes a housing configured to be supported by the hand of a user, the housing having a distal end and a proximal end, a drive system disposed within the housing and configured to rotate a rotation member, an engagement member coupled to the rotation member and configured to be remotely coupled to an elongate medical device to transfer rotational movement of the rotation member to rotational movement of an elongate medical device, an activation member carried by the housing such that the activation member can be operated by at least a portion of the hand of the user when the housing is supported by the hand of the user, and wherein the drive system is configured to apply a combination of motive force components to the engagement member. In accordance with the present invention, the combination of motive force components includes an alternating clockwise motion and counter-clockwise motion. In some embodiments, the combination of motive force components comprises a rotational motion and a cyclic longitudinal motion. In some embodiments, the activation member comprises a handle coupled to the housing and configured to be operable by the hand of the user. In some embodiments, the handle is configured to couple to the drive system mechanically. In some embodiments, the rotation member includes a tube having a window. In some embodiments, the manipulation device further includes a motor operatively coupled to the drive system, wherein the activation member is configured to initiate operation of the motor. In some embodiments, the manipulation device further includes gearing coupled to the motor. In some embodiments, the activation member includes a switch. In some embodiments, the elongate medical device consists of at least one of a guidewire, a basket, an expandable device, a catheter shaft, a macerator, or a cutting device. In some embodiments, the combination of motive force components comprises a helical motion. In some embodiments, the combination of motive force components comprises a jackhammer motion.

In another embodiment not forming part of the claimed invention, a method for treating a patient having thrombus comprises providing a manipulation device comprising a housing configured to be supported by the hand of a user, the housing having a distal end and a proximal end, a drive system disposed within the housing and configured to rotate a rotation member, an engagement member coupled to the rotation member, and configured to be removably coupled to an elongate medical device, an activation member carried by the housing such that it can be operated by at least a portion of the hand of the user when the housing is supported by the hand of the user, and wherein the drive system is configured to apply motive force to the engagement member, securing an elongate member to the engagement member, the elongate member having a distal end configured for introduction into a patient's vasculature, introducing at least the distal end of the elongate member into a blood vessel adjacent a thrombus, operating the activation member to cause at least some rotation of the rotation member, which in turn causes at least some rotation of the distal end of the elongate member at or near the thrombus, and aspirating at least some thrombus with an aspiration catheter. In accordance with the present invention, the motive force comprises a combination of motive force components including an alternating clockwise motion and counter-clockwise motion. In some embodiments, the combination of motive force components comprises a rotational motion and a cyclic longitudinal motion. In some embodiments, the activation member comprises a handle coupled to the housing and configured to be operable by the hand of the user. In some embodiments, the handle is configured to couple to the drive system mechanically. In some embodiments, the rotation member comprises a tube including a window. In some embodiments, the manipulation device further comprises a motor operatively coupled to the drive system, wherein the activation member is configured to initiate operation of the motor. In some embodiments, the manipulation device further comprises gearing coupled to the motor. In some embodiments, the activation member comprises a switch. In some embodiments, the elongate medical device consists of at least one of a guidewire, a basket, an expandable device, a catheter shaft, a macerator, and a cutting device. In some embodiments, the combination of motive force components comprises a helical motion. In some embodiments, the combination of motive force components comprises a jackhammer motion. In some embodiments, the elongate member comprises a guidewire. In accordance with the present invention, the distal end of the elongate member is substantially straight. In some embodiments, the distal end of the elongate member is curved. In some embodiments, at least a portion of the aspiration catheter extends alongside at least a portion of the elongate member within a delivery lumen of a delivery catheter. In some embodiments, the at least some rotation of the distal end of the elongate member facilitates movement of the thrombus through the delivery lumen of the delivery catheter. In some embodiments, the delivery catheter is a coronary guiding catheter. In some embodiments, the elongate member extends within a lumen of the aspiration catheter. In some embodiments, the elongate member extends within an aspiration lumen of the aspiration catheter. In some embodiments, the elongate member is rotatable within the lumen of the aspiration catheter. In some embodiments, the at least some rotation of the distal end of the elongate member facilitates movement of the thrombus through the lumen of the aspiration catheter. In some embodiments, the aspiration catheter comprises a supply lumen and an aspiration lumen, the supply lumen having a wall and a closed distal end, the aspiration lumen configured to couple to a vacuum source and having an interior wall surface and an open distal end, the wall of the supply lumen having an orifice in fluid communication with the interior of the aspiration lumen, the orifice located proximally of the open end of the aspiration lumen and adjacent the closed distal end of the supply lumen. In some embodiments, the method further comprises providing a tubing set having a first conduit configured to couple the supply lumen of the aspiration catheter to a fluid source, and a pump component associated with the first conduit and configured to detachably couple to a drive unit, such that the motion from the drive unit is transferred to the pump component such that resultant motion of the pump component causes fluid from the fluid source to be injected through the supply lumen of the aspiration catheter, and through the orifice into the aspiration lumen. In some embodiments, the pump comprises a piston. In some embodiments, the orifice is configured to create a spray pattern when pressurized fluid is pumped through the supply lumen such that the spray pattern impinges on the interior wall surface of the aspiration lumen. In some embodiments, the aspiration catheter comprises a tubular aspiration member having a proximal end, a distal end, and a lumen, and configured to at least partially extend out of the lumen of a delivery catheter having a lumen, and into the vasculature of a subject, an elongate support member coupled to the tubular aspiration member and extending between a proximal end of the aspiration catheter and the proximal end of the tubular aspiration member, and an annular seal comprising at least one annular sealing member coupled to the tubular aspiration member.

In another embodiment, a method for breaking up a thrombus or embolus comprises providing a manually-operated guidewire manipulation device comprising a housing having a proximal end, an elongate body, and a distal end, a rotation member disposed within the housing and configured to rotate with respect to the housing, a locking assembly operably coupled to a distal end of the rotation member, the locking assembly having a locked mode wherein the rotation member is engaged with the guidewire, and an unlocked mode wherein the rotation member is disengaged from the guidewire, a handle coupled to the housing and configured to be operable by one hand of a user, and a drive system operably coupled to the handle, the drive system configured to rotate the rotation member upon actuation of the handle by the one hand of the user in a first direction with respect to the housing, thereby causing the guidewire to rotate in a first rotational direction when the locking assembly is in the locked mode, wherein the handle is configured to be releasable by the user such that the handle when released moves in a second direction with respect to the housing, the second direction opposite from the first direction, wherein the handle is configured to cause rotation of the rotation member in a second rotational direction opposite the first rotational direction when the handle moves in the second direction, thereby causing the guidewire to rotate in the second rotational direction, securing a guidewire to the rotation member via the locking assembly, the guidewire having a distal end extending through the lumen of a catheter and into a patient's vasculature, operating the manually-operated guidewire manipulation device to cause at least some rotation of the rotation member, which in turn causes at least some rotation of the guidewire, and aspirating at least some thrombus or embolus through the lumen of the catheter. In some embodiments, the catheter is an aspiration catheter. In some embodiments, the lumen is an aspiration lumen. In some embodiments, the aspiration lumen is also a guidewire lumen. In some embodiments, the catheter is a guiding catheter.

In some embodiments described herein, instead of a chuck being rotated, luer lock connector may instead be rotated. For example, a rotatable male luer lock connector may be coupled to a medical device (such as an elongated medical device, which may include a catheter), in order to rotated the medical device.

Claim 1:
A system for treating a patient having thrombus, comprising:
an aspiration catheter (<NUM>, <NUM>) having a distal end for placement into a blood vessel, a proximal end, and an aspiration lumen (<NUM>, <NUM>) having an open distal end (<NUM>) and extending between the distal end and the proximal end of the aspiration catheter (<NUM>, <NUM>), the aspiration lumen (<NUM>, <NUM>) configured to be coupled to a vacuum source (<NUM>);
an elongate member (<NUM>, <NUM>) having a distal end (<NUM>) and a proximal end (<NUM>), the distal end (<NUM>) having a straight distal portion (<NUM>) such that the elongate member (<NUM>, <NUM>) is configured to be inserted through the aspiration lumen (<NUM>, <NUM>) of the aspiration catheter (<NUM>, <NUM>), such that the distal end (<NUM>) extends from the aspiration lumen (<NUM>, <NUM>) into a thrombus within the blood vessel, wherein the elongate member (<NUM>, <NUM>) includes a first portion configured to reside within the aspiration lumen (<NUM>, <NUM>) and to facilitate the movement of partially or completely macerated thrombus through the aspiration lumen (<NUM>, <NUM>) while the elongate member (<NUM>, <NUM>) is moved in relation to the aspiration catheter (<NUM>, <NUM>);
a manipulation device (<NUM>, <NUM>) comprising:
a housing (<NUM>, <NUM>) configured to be supported by the hand of a user, the housing (<NUM>, <NUM>) having a distal end (<NUM>, <NUM>) and a proximal end (<NUM>, <NUM>);
a drive system disposed within the housing (<NUM>, <NUM>), and configured to rotate a rotation member (<NUM>, <NUM>);
an engagement member coupled to the rotation member (<NUM>, <NUM>), and configured to be removably coupled to the elongate member (<NUM>, <NUM>) to transfer rotational movement of the rotation member (<NUM>, <NUM>) to rotational movement of the elongate member (<NUM>, <NUM>); and
an activation member (<NUM>, <NUM>) carried by the housing (<NUM>, <NUM>) such that it can be operated by at least a portion of the hand of the user when the housing (<NUM>, <NUM>) is supported by the hand of the user; and
wherein the drive system is configured to apply motive force to the engagement member to thereby move the elongate member (<NUM>, <NUM>), wherein the motive force comprises a combination of motive force components comprising an alternating clockwise motion and counter-clockwise motion.