Patent Description:
A wide variety of medical devices have been developed for medical use, for example, for use in accessing body cavities and interacting with fluids and structures in body cavities. Some of these devices may include guidewires, catheters, pumps, motors, controllers, filters, grinders, needles, valves, and delivery devices and/or systems used for delivering such devices. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages.

<CIT> relates to devices utilized in removing tissue from body passageways, such as removal of atherosclerotic plaque from arteries, utilizing a rotational atherectomy device. <CIT> relates to systems, system components, and methods for removing material from a lumen of a mammalian subject using an advanceable, rotating cutter assembly. <CIT> relates to devices and methods for removing tissue from body passageways, such as removal of atherosclerotic plaque from arteries, utilizing a rotational atherectomy device.

This disclosure provides, design, material, manufacturing method and use alternatives for medical devices and systems. An advancer assembly for an atherectomy device includes a housing, a drive mechanism positioned within the housing, an actuation mechanism in communication with the drive mechanism and accessible from exterior of the housing, and the actuation mechanism adjusts a setting of a first operation module of the advancer assembly and a setting of a second operation module of the advancer assembly upon a single adjustment of the actuation mechanism. The first operation module of the advancer assembly for the atherectomy device is a speed module configured to adjust a speed setting of the drive mechanism between a first speed setting, a second speed setting, and a zero speed setting in response to the adjustment of the actuation mechanism.

In addition or alternative and in a third aspect, an actuation of the actuation mechanism of the advancer assembly for the atherectomy device may further initiate actuation of the drive mechanism according to the adjusted speed setting.

In addition or alternative and in a fourth aspect, the advancer assembly for an atherectomy device may include a third operation module of the advancer assembly, which may be a lock module configured to activate or deactivate a lock assembly, wherein the adjustment of the actuation mechanism deactivates the lock assembly.

The second operation module of the advancer assembly is a braking module configured to activate or deactivate a braking assembly configured to engage a guidewire extending through the housing in response to the adjustment of the actuation mechanism.

In addition or alternative and in a sixth aspect, the actuation of the actuation mechanism of the advancer assembly for an atherectomy device may adjust a setting of a third operation module of the advancer assembly.

In addition or alternative and in a seventh aspect, the third operation module of the advancer assembly may be a lock module configured to activate or deactivate a lock assembly in response to the adjustment of the actuation mechanism.

In addition or alternative and in an eighth aspect, the actuation mechanism of the atherectomy device may comprise a knob that is axially slidable along the housing.

In addition or alternative and in a ninth aspect, the adjustment of the actuation mechanism may be a first adjustment of the actuation mechanism, and a second adjustment of the actuation mechanism may further adjust the setting of the first operation module of the advancer assembly and the setting of the second operation module of the advancer assembly.

In addition or in alternative and in a tenth aspect, an atherectomy device may comprise an advancer assembly having a knob assembly, a rotation assembly in communication with the advancer assembly, wherein the knob assembly may be longitudinally adjustable to advance and retract the rotation assembly, and wherein adjustment of the knob assembly may be configured to adjust a lock setting for the knob assembly and a speed setting on which a rotation of the rotation assembly is based.

In addition or in alternative and in an eleventh aspect, the adjustment of the knob assembly of the atherectomy device may be further configured to adjust a setting for a brake assembly of the advancer assembly.

In addition or in alternative and in a twelfth aspect, the advancer assembly of the atherectomy device may comprise a housing and a drive mechanism positioned within the housing.

In addition or in alternative and in a thirteenth aspect, the knob assembly of the atherectomy device may be in communication with the drive mechanism and may be accessible from an exterior of the housing.

In addition or in alternative and in a fourteenth aspect, the rotation assembly of the atherectomy device may comprise an elongate member coupled to a rotational device at a distal end of the elongate member.

In addition or in alternative and in a fifteenth aspect, the knob assembly of the atherectomy device may be in communication with the drive mechanism and the drive mechanism may be configured to rotate the elongate member based on the speed setting.

In addition or in alternative and in a sixteenth aspect, the knob assembly of the atherectomy device may be in electrical communication with the drive mechanism.

In addition or in alternative and in a seventeenth aspect, a method of operating an atherectomy device, not forming part of the claimed invention, may comprise adjusting an actuator of an advancer assembly of the atherectomy device a first time to adjust a speed setting of a drive mechanism to a first speed setting of a plurality of speed settings and adjust a brake setting of a brake module between a deactivated state setting and an activated state setting, longitudinally translating the actuator to advance the advancer assembly, and adjusting the actuator of the advancer assembly a second time after longitudinally translating the actuator.

In addition or alternative and in an eighteenth aspect, actuating the actuator may activate or deactivate a lock assembly of the advancer assembly.

In addition or alternative and in a nineteenth aspect, the actuation of the actuator the first time may adjust the setting of the speed of the drive mechanism to an advance speed and may adjust the brake setting to the activated state setting.

In addition or alternative and in a twentieth aspect, the adjusting of the actuator the second time may adjust the setting of the speed of the drive mechanism to a zero speed and may adjust the brake setting to the deactivated state setting.

The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:.

Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used in connection with other embodiments whether or not explicitly described unless clearly stated to the contrary.

Cardiovascular disease and peripheral arterial disease may arise from accumulation of atheromatous material on the inner walls of vascular lumens, resulting in a condition known as atherosclerosis. Atheromatous and other vascular deposits may restrict blood flow and can cause ischemia in a heart of a patient, vasculature of a patient's legs, a patient's carotid artery, etc. Such ischemia may lead to pain, swelling, wounds that will not heal, amputation, stroke, myocardial infarction, and/or other conditions.

Atheromatous deposits may have widely varying properties, with some deposits being relatively soft and others being fibrous and/or calcified. In the latter case, the deposits may be referred to as plaque. Atherosclerosis occurs naturally as a result of aging, but may also be aggravated by factors such as diet, hypertension, heredity, vascular injury, and the like. Atherosclerosis may be treated in a variety of ways, including drugs, bypass surgery, and/or a variety of catheter-based approaches that may rely on intravascular widening or removal of the atheromatous or other material occluding the blood vessel. Atherectomy is a catheter-based intervention that may be used to treat atherosclerosis.

Atherectomy in an interventional medical procedure performed to restore a flow of blood through a portion of a patient's vasculature that has been blocked by plaque or other material (e.g., blocked by an occlusion). In an atherectomy procedure, a device on an end of a drive shaft that is used to engage and/or remove (e.g., abrade, grind, cut, shave, etc.) plaque or other material from a patient's vessel (e.g., artery or vein). In some cases, the device on an end of the drive shaft may be abrasive and/or may otherwise be configured to remove plaque from a vessel wall or other obstruction in a vessel when the device is rotating and engages the plaque or other obstruction.

<FIG> depicts an atherectomy system <NUM>. The atherectomy system <NUM> may be electrically driven, pneumatically driven and/or driven in one or more other suitable manners. Additional or alternative components to those illustrated and described herein may be utilized in the operation of the atherectomy system <NUM>.

The atherectomy system <NUM> may include a drive assembly <NUM> and a control unit <NUM> (e.g., a controller). The drive assembly <NUM> may include, among other elements, an advancer assembly <NUM> and a rotation assembly <NUM>. Although the control unit <NUM> is depicted as being separate from the drive assembly <NUM> in <FIG>, the functionality of the control unit <NUM> and the drive assembly <NUM> may be incorporated into a single component (e.g., in the advancer assembly <NUM> or other suitable single component).

The rotation assembly <NUM> may include a drive shaft <NUM> (e.g., an elongate member that may be or may include a flexible drive shaft or other suitable drive shaft), a rotational device <NUM> (e.g., a rotational tip or other rotational device), and an elongate member <NUM> having a first end (e.g., a proximal end), a second end (e.g., a distal end), and a lumen extending from the first end to the second end for receiving the drive shaft <NUM>. In some cases, the elongate member <NUM> may be an elongated tubular member. The rotational device <NUM> may have a rough or sharp surface, such that it is configured to grind, abrade, cut, shave, etc. plaque from a vessel wall or other obstruction in a vessel when it is rotated.

The advancer assembly <NUM> includes a knob <NUM>, a housing <NUM>, a drive mechanism (e.g., the drive mechanism <NUM> shown, for example, in <FIG>), and/or one or more other suitable components. The housing <NUM> at least partially houses the drive mechanism and the knob <NUM> is at least partially accessible from an exterior of the housing <NUM>. The drive mechanism may be or may include a motor (e.g., an electric motor, pneumatic motor, or other suitable motor) at least partially housed within the housing <NUM> and in communication with the knob <NUM>, the drive shaft <NUM>, and the control unit <NUM>. The knob <NUM> may be configured to advance along a longitudinal path to longitudinally advance the drive mechanism <NUM> and the rotation assembly <NUM>.

The drive mechanism may be coupled to the drive shaft <NUM> in a suitable manner including, but not limited to, a weld connection, a clamping connection, an adhesive connection, a threaded connection, and/or other suitable connection configured to withstand rotational speeds and forces. As the drive shaft <NUM> may rotate over a wide range of speeds (e.g., at speeds of between zero (<NUM>) RPM and <NUM>,<NUM> RPM or higher), the coupling between the drive mechanism and the drive shaft <NUM> may be configured to withstand such rotational speeds and associated forces.

The drive shaft <NUM> may be formed from one or more of a variety of materials. For example, the drive shaft <NUM> may be formed from one or more of a variety of materials, including steel, stainless steel, other metal, polymer, and/or other suitable materials.

The drive shaft <NUM> may have a suitable diameter and/or length for traversing vasculature of a patient. The diameter and/or the length of the drive shaft <NUM> may depend on the dimension of the lumen of the elongate member <NUM>, the dimensions of vessels of a patient to be traversed, and/or one or more other suitable factors. In some cases, the drive shaft <NUM> may have a diameter in a range from about <NUM> centimeters (cm) or smaller to about <NUM> or larger and a working length in a range from about ten (<NUM>) cm or shorter to about three hundred (<NUM>) cm or longer. In one example, the drive shaft <NUM> may have a diameter of about <NUM> and a length of about fifty (<NUM>) cm. Alternatively, the drive shaft <NUM> may have a different suitable diameter and/or different suitable length.

The rotational device <NUM> may have an outer perimeter which is equal to or larger than a distal diameter of the drive shaft <NUM> and/or the elongate member <NUM>. Alternatively or in addition, the rotational device <NUM> may have an outer perimeter which is smaller than a diameter of the drive shaft <NUM> and/or the elongate member <NUM>. The rotational device <NUM> may have a symmetric design so that it penetrates equally well in both rotational directions, but this is not required and the rotational device <NUM> may be configured to penetrate in only one direction.

The rotational device <NUM> may be coupled to the drive shaft <NUM>. Where the drive shaft <NUM> has a first end portion (e.g., a proximal end portion) and a second end portion (e.g., a distal end portion), the rotational device <NUM> may be coupled to the drive shaft <NUM> at or near the second end portion. In some cases, the rotational device <NUM> may be located at or adjacent a terminal end of the second end portion of the drive shaft <NUM>.

The rotational device <NUM> may be coupled to the drive shaft <NUM> in any manner. For example, the rotational device <NUM> may be coupled to the drive shaft <NUM> with an adhesive connection, a threaded connection, a weld connection, a clamping connection, and/or other suitable connection configured to withstand rotational speeds and forces. Similar to as discussed above with respect to the connection between the drive shaft <NUM> and the drive mechanism, as the drive shaft <NUM> and/or the rotational device <NUM> may rotate at speeds between zero (<NUM>) RPM and <NUM>,<NUM> RPM or higher, the coupling between the drive shaft <NUM> and the rotational device <NUM> may be configured to withstand such rotational speeds and associated forces.

The drive assembly <NUM> and the control unit <NUM> may be in communication and may be located in or may have a same housing and/or located in or have separate housings (e.g., the advancer assembly housing <NUM> and a control unit housing <NUM> or other housings). Whether in the same housing or in separate housings, the drive assembly <NUM> and the control unit <NUM> may be in communication through a wired connection (e.g., via one or more wires in an electrical connector <NUM> or other suitable electrical connector) and/or a wireless connection. Wireless connections may be made via one or more communication protocols including, but not limited to, cellular communication, ZigBee, Bluetooth, Wi-Fi, Infrared Data Association (IrDA), dedicated short range communication (DSRC), EnOcean, and/or any other suitable common or proprietary wireless protocol, as desired.

Although not necessarily shown in <FIG>, the drive assembly <NUM> may include and/or enclose one or more operational features. For example, among other features, the drive assembly <NUM> may include a motor (e.g., as discussed above and/or other suitable motor), rubber feet, control electronics, drive circuitry, etc..

The control unit <NUM>, which may be separate from the drive assembly <NUM> (e.g., as shown in <FIG>) or may be included in the drive assembly <NUM>, may include several features. For example, as shown in <FIG>, the control unit <NUM> may include a display <NUM> and a control knob <NUM> (e.g., a motor speed (e.g., RPM or other speed) adjustment knob or other control knob). Additionally or alternatively, the control unit <NUM> may include one or more other features for controlling the drive mechanism and/or other features of the drive assembly <NUM> (e.g., one or more drive mechanism states of the drive mechanism) including, but not limited to, a processor, memory, input/output devices, a speaker, volume control buttons, on/off power supply switch, motor activation switch, a timer, a clock, and/or one or more other features.

In some cases, the control unit <NUM> may include one or more drive mechanism load output control mechanisms for controlling an operation of the atherectomy system <NUM>. In one example of a drive mechanism load output control mechanism that may be included in the control unit <NUM>, the control unit <NUM> may include a mechanism configured to set and/or adjust an advancing load output (e.g., a rotational speed) and/or a retracting load output from the drive mechanism <NUM>. Additionally or alternatively, the control unit <NUM> may include other control and/or safety mechanism for controlling the operation of the atherectomy system <NUM> and mitigating risks to patients.

<FIG> depicts a box diagram of the drive assembly <NUM> including the rotation assembly <NUM> and the advancer assembly <NUM>. As discussed above, the rotation assembly <NUM> may include, among other components, the drive shaft <NUM>, the rotational device <NUM>, and the elongate member <NUM>. The advancer assembly <NUM> may include (e.g., at least partially within the housing <NUM> depicted in <FIG>), among other components, a knob assembly <NUM>, a speed module <NUM>, a braking module <NUM>, and a lock module <NUM>.

The components of the advancer assembly <NUM> may be configured to communicate directly with one or more other components of the advancer assembly <NUM>. Additionally or alternatively, the components of the advancer assembly <NUM> may communication with one or more other components of the advancer assembly <NUM> through electrical connections with a central controller having one or more processors, memory, and/or one or more other components of the advancer assembly <NUM>.

The knob assembly <NUM> may be or may include the knob <NUM> (e.g., an actuator or actuation mechanism of the knob assembly <NUM>) that is at least partially accessible for adjustment and/or actuation from exterior of the housing <NUM> of the advancer assembly <NUM>. Additionally or alternatively, the knob assembly <NUM> may include electrical connections, one or more processors, and/or memory to facilitate receiving input at the knob <NUM> and transferring signals to other components of the advancer assembly <NUM>. The knob assembly <NUM> is in direct or indirect (e.g., indirectly via the central controller and/or other components, if desired) communication with one or more of the speed module <NUM>, the braking module <NUM>, the lock module <NUM> and/or other components of drive assembly <NUM> through an electrical connection, a mechanical connection, and/or other suitable connections. In accordance with the present invention, a single adjustment or actuation of the knob assembly <NUM> is configured to change two or more settings of the modules of the advancer assembly <NUM>.

The knob <NUM> may be adjusted and/or actuated in one or more directions. For example, the knob <NUM> may be longitudinally adjustable to longitudinally adjust and/or position the knob assembly <NUM>, the knob <NUM> may be configured to rotate in a clockwise direction and/or a counter-clockwise direction, the knob <NUM> may be configured to be actuated in an axial direction along an axis about which the knob <NUM> may rotate, and/or the knob <NUM> may be adjusted and/or actuated in one or more other suitable manners. In some cases, adjustment and/or actuation of the knob <NUM> may adjust one or more settings of one or more other components of the advancer assembly <NUM>, as discussed in further detail below.

Although the FIGs. depict the knob <NUM> as being an actuator or actuation mechanism of the knob assembly <NUM>, it is contemplated that the actuator or actuation mechanism of the knob assembly <NUM> may take on one or more other forms. For example, the knob assembly <NUM> may include an actuator or actuation mechanism being and/or having one or more of a physical button, a virtual button, a virtual knob, a physical knob, a touch sensitive surface, a shape other than what is depicted in the FIGs. , one or more colors and/or color combinations, and/or other suitable feature configured for actuation or adjustment.

The speed module <NUM> may include or may be in communication with the drive mechanism <NUM> via an electrical connection, a mechanical connection, and/or other suitable connections, to adjust a desired speed setting of the drive mechanism <NUM>. Additionally or alternatively, the knob assembly <NUM> may include electrical connections, one or more processors, and/or memory to facilitate receiving input signals initiated from the knob assembly <NUM> and using the received signals to directly or indirectly (e.g., indirectly via the central controller, if desired) control settings and/or operation of the drive mechanism <NUM>.

In some cases, the speed module <NUM> may be configured to adjust a speed setting of the drive mechanism <NUM> between a zero (<NUM>) speed setting and one or more additional speed settings and/or actuate a mode of the drive mechanism <NUM> in response to input or communications received from the knob assembly <NUM> or the central controller. In accordance with the present invention, in response to a received input that is initiated by adjustment of the knob <NUM>, the speed module <NUM> is configured to adjust a speed setting between one of a zero (<NUM>) speed setting, a first speed setting (e.g., an advance speed setting), and a second speed setting (e.g., a withdraw or retract speed setting) and another one of the zero (<NUM>) speed setting, the first speed setting, and the second speed setting. The first speed setting is associated with a rotational speed for the rotational device <NUM> that facilitates advancement of the rotational device <NUM> through an obstruction or occlusion in a vessel of the patient and the second speed setting is associated with a rotational speed for the rotational device <NUM> that facilitates withdrawal (e.g., retraction) of the rotational device <NUM> within the vessel while mitigating risks of injury to the patient. The second speed setting may be lower than the first speed setting in the above example, but this is not required. In another example, in response to a received input that is initiated by actuation or adjustment of the knob <NUM>, the speed module <NUM> may actuate the drive mechanism <NUM> between an off mode and an on mode to initiate rotation of the drive mechanism <NUM> at a desired or set speed setting and accordingly rotate the rotational device <NUM>.

The braking module <NUM> may include a braking assembly <NUM> configured to engage a guidewire extending through the advancer assembly <NUM> and prevent rotation of the guidewire when the drive shaft <NUM> and/or the rotational device <NUM> rotate. Additionally or alternatively, the braking module <NUM> may include electrical connections, a processor, and/or memory configured to directly or indirectly (e.g., indirectly via the central controller, if desired) receive communications and/or other suitable inputs initiated by adjustment of the knob assembly <NUM> and adjust a brake setting (e.g., between an activated setting and a deactivated setting and/or between other suitable settings) of the braking assembly <NUM> in response to the communications and/or other inputs received. In one example, when the braking module <NUM> has set the braking assembly <NUM> to a deactivated setting, adjustment of the knob assembly <NUM> may result in initiating a signal to the braking module <NUM> for the braking assembly <NUM> to enter an activated setting and engage a guidewire extending through the advancer assembly <NUM>. Then, further adjustment of the knob assembly <NUM> may result in initiating a signal to the braking module <NUM> for the braking assembly <NUM> to enter a deactivated setting and disengage the guidewire to allow the rotation assembly <NUM> to be withdrawn over the guidewire.

The braking assembly <NUM> may engage the guidewire extending through the advancer assembly <NUM> via a friction fit, a pinch fit, a pressure fit, and/or one or more other suitable types of engagement when in an activated setting. In one example braking assembly <NUM> may be an electromechanical brake system configured to receive an electrical signal and in response to the electrical signal, either grasp the guidewire extending through the advancer assembly <NUM> or let go of the guidewire extending through the advancer assembly <NUM>. Alternatively, the braking assembly <NUM> may be mechanical in nature and may be initiated through mechanical initiation. In an example of a mechanical braking assembly <NUM>, the braking assembly <NUM> may adjust and grasp or otherwise engage the guidewire extending through the housing <NUM> of the advancer assembly <NUM> as the knob <NUM> rotates. Other mechanical and/or electromechanical braking configurations are contemplated.

The lock module <NUM> may include a locking assembly <NUM> to lock the knob assembly <NUM> at a longitudinal location along the housing <NUM> of the advancer assembly <NUM> in response to communications and/or other suitable inputs initiated by the knob assembly <NUM>. Additionally or alternatively, the locking assembly <NUM> may include electrical connections, a processor, and/or memory configured to directly or indirectly (e.g., indirectly via the central controller or other suitable components, if desired) receive the communications and/or other suitable inputs initiated by adjustment of the knob assembly <NUM> and adjust a lock setting (e.g., between and activated setting and a deactivated setting and/or between other suitable settings) of the locking assembly <NUM> in response to the communications and/or other inputs received. In one example, when the lock module <NUM> has set the locking assembly <NUM> to a deactivated setting, adjustment of the knob assembly <NUM> may result in initiating a signal to the lock module <NUM> for the locking assembly <NUM> to enter an activated setting and prevent the knob assembly <NUM> from adjusting longitudinally with respect to the housing <NUM> of the advancer assembly <NUM>. Then, further adjustment of the knob assembly <NUM> may result in initiating a signal to the lock module <NUM> for the locking assembly <NUM> to enter a deactivated setting and allow the knob assembly <NUM> to adjust longitudinally with respect to the housing <NUM> of the advancer assembly <NUM>.

The locking assembly <NUM> may be configured to lock the knob assembly <NUM> at a longitudinal location along the housing <NUM> of the advancer assembly <NUM> in one or more suitable manners. In one example, the locking assembly <NUM> may be configured to engage the housing <NUM> or a feature extending from the housing <NUM> via a friction fit, a pinch fit, a pressure fit, and/or one or more other suitable types of engagement when in an activated setting. In one example, the locking assembly may be an electromechanical lock system configured to receive an electrical signal and in response to receiving the electrical signal, either engage the housing <NUM> and/or other component of the advancer assembly <NUM> or disengage the housing <NUM> and/or other component of the advancer assembly <NUM>. Alternatively, the locking assembly <NUM> may be mechanical in nature and may be initiated through mechanical initiation. In an example of a mechanical locking assembly <NUM>, the locking assembly <NUM> may rotate and engage the housing <NUM> of the advancer assembly <NUM> as the knob <NUM> is rotating. In another example, the locking assembly <NUM> may be biased in a lock position and move to an unlocked position in response to actuation. Other mechanical and/or electromechanical locking configurations are contemplated.

<FIG> depict the example advancer assembly <NUM> showing the knob assembly <NUM> in various modes based on position configurations of the knob <NUM>, where each mode of the knob assembly <NUM> is configured to set settings of various modules to predetermined settings. The described modes of the knob assembly <NUM> and associated settings for modules of the advancer assembly <NUM> are illustrative and it is contemplated other modes of the knob assembly <NUM> and/or settings of the modules may be utilized, as desired. Although the knob <NUM> is depicted and described as being associated with modes of the knob assembly <NUM> at quarter (<NUM>/<NUM>) turn positions in <FIG> (e.g., where a full turn is <NUM> degrees), it is contemplated that the knob <NUM> may be positioned and/or associated with one or modes of the knob assembly <NUM> at any suitable rotatable position relative to a full turn of the knob <NUM> (e.g., half (<NUM>/<NUM>) turns, eighth (<NUM>/<NUM>) turns, three quarter (<NUM>/<NUM>) turns, other suitable partial or full turns, and the like).

<FIG> depicts the advancer assembly <NUM> with the knob <NUM> in a distal or forward configuration and setting the knob assembly <NUM> to an advance mode. <FIG> depicts the advancer assembly <NUM> with the knob <NUM> in an upward configuration and setting the knob assembly <NUM> to a lock mode. <FIG> depicts the advancer assembly <NUM> with the knob <NUM> in a proximal or backward configuration and setting the knob assembly <NUM> to a withdraw mode. <FIG> depicts the advancer assembly <NUM> with the knob <NUM> in a downward configuration and setting the knob assembly <NUM> to the lock mode. Although <FIG> depict the knob <NUM> sequentially adjusted in a clockwise direction, it is contemplated that the knob <NUM> may be rotated in a counter-clockwise direction.

In some cases, the knob <NUM> or the knob assembly <NUM> may include a knob indicator that indicates or points to a configuration of the knob <NUM> and a mode of the knob assembly <NUM>. In the example of <FIG>, the knob <NUM> may include a knob indicator <NUM>. The knob indicator <NUM> may be a dot on, an arrow-shaped portion of, the inherent shape of the knob <NUM>, color of the knob <NUM>, or other suitable configuration on or of the knob <NUM>, as desired.

The advancer assembly <NUM> may include, as discussed above, the knob assembly <NUM>, the speed module <NUM>, the braking module <NUM>, and the lock module <NUM>, and one or more settings of the speed module <NUM>, the braking module <NUM>, and/or the lock module <NUM> may be adjusted in response to adjustment and/or actuation of the of the knob <NUM> between the example configurations depicted in <FIG> and/or other suitable configurations. Such a configured advancer assembly <NUM> of an atherectomy system <NUM> may facilitate limiting a number of steps required to prepare settings for different modules or components of the atherectomy system <NUM> prior to and/or during use of the atherectomy system <NUM> in a procedure. For example, adjusting the knob <NUM> to point distally or forward, as depicted in <FIG> and discussed in greater detail below, or other single adjustment of an actuator or actuation mechanism may adjust settings of the speed module <NUM>, the braking module <NUM>, and/or the lock module <NUM> for advancement of a rotational device (e.g., the rotational device <NUM> or other suitable rotational device) within a vessel of a patient, whereas in previous atherectomy systems it was necessary to separately adjust a speed setting (e.g., with a foot pedal), adjust a brake setting (e.g., on an advancer assembly), and adjust a lock mechanism (e.g., at a knob) to prepare the atherectomy system for advancement of the rotational device within a vessel of a patient. The single adjustment of an actuator or actuator mechanism to adjust settings of multiple components of the atherectomy system <NUM> mitigates human error by requiring fewer steps when changing how the atherectomy system is being used (e.g., between advancement and retraction, etc.).

To further facilitate ease of use of the atherectomy system <NUM> and as depicted in <FIG>, the housing <NUM> of the advancer assembly <NUM> may include indicia on an outer surface <NUM>. When included, the indicia on the housing <NUM> may include, but is not limited to, descriptive indicia indicating a mode in which the knob assembly <NUM> is positioned. This indicia may be graphical representations of the modes in which the knob assembly <NUM> is positioned (e.g., a lock icon representing a lock mode, a retract icon representing a retract mode, etc.). Additionally or alternatively, indicia may be provided at predetermined and/or consistent locations along an opening <NUM> to provide a user (e.g., a physician or other user) with a measurement or other indication of an axial position of the drive mechanism <NUM>, the drive shaft <NUM>, and/or the rotational device <NUM>. Such indicia may be tick marks, measurements (e.g., millimeters, centimeters, inches, etc.), and/or other suitable indicia that facilitate providing an understanding of a relative position of the knob assembly <NUM> and/or the drive mechanism <NUM> along the opening <NUM>. Additionally or alternatively, the shape and/or color of the knob <NUM> may indicate a mode in which the knob assembly <NUM> is positioned (e.g., the knob <NUM> may include one or more colors, where the color of the knob <NUM> at a predetermined position (e.g., a forward position, a backward position, a side position, a position aligned with indicia on the housing <NUM>, and/or other suitable predetermined position) indicates a current mode of the knob assembly <NUM>). Further, in some cases, a brake indicator <NUM> may be included on and/or adjacent the outer surface <NUM> of the housing <NUM> to indicate (e.g., by luminescence, LED, digital display, and/or other suitable types of indicia) to a user that the braking assembly <NUM> is in one of an activated mode and a deactivated mode.

<FIG> depicts an example of the advancer assembly <NUM> showing the knob assembly <NUM> in the advance mode. When the knob assembly <NUM> is set to the advance mode, the knob indicator <NUM> of or in communication with the knob <NUM> may be directed toward a distal end of the advancer assembly <NUM>. Although various modes of the knob assembly <NUM> and/or setting of modules of the advancer assembly <NUM> may be described as being associated with a position of the knob <NUM> or direction of the knob indicator <NUM>, the modes and/or settings of modules may be associated with any suitable position of the knob <NUM> or direction of the knob indicator <NUM>.

When the knob assembly <NUM> is set to the advance mode, a signal may be initiated such that the braking module <NUM> may receive a signal to adjust a brake setting to an activated setting. When the braking module <NUM> is in the activated brake setting, the braking assembly <NUM> may engage a guidewire <NUM>, as discussed above with respect to <FIG>, and may restrict movement (e.g., rotational and/or longitudinal movement) of the guidewire <NUM> relative to the rotation assembly <NUM> and/or the advancer assembly <NUM>. Further, when the braking module <NUM> is in the activated setting, the brake indicator <NUM> may be illuminated, as shown for example in <FIG>, or turned off to indicate the braking module <NUM> is in the activated setting.

Further, the signal initiated when the knob assembly <NUM> is set to the advance mode may result in the lock module <NUM> receiving a signal to adjust a lock setting to a deactivated setting. When the lock module <NUM> is in the deactivated lock setting, the locking assembly <NUM> may unlock the knob assembly <NUM> relative to the housing <NUM> of the advancer assembly <NUM>. Unlocking the knob assembly <NUM> relative to the housing <NUM> may allow for movement of the knob <NUM> along the longitudinal slot or opening <NUM> to advance and/or withdraw the rotational device <NUM> (not shown in <FIG>) in communication with knob assembly <NUM> with respect to the advancer assembly <NUM>. In some cases, tick marks or other indicia along the longitudinal slot or opening <NUM> may indicate to a user how far the rotational device has been advanced as the knob <NUM> adjusts longitudinally.

Further, the signal initiated when the knob assembly <NUM> is set to the advance mode may result in the speed module <NUM> receiving a signal to adjust a speed setting to a first speed setting (e.g., an advance speed setting). When the speed module <NUM> is in the first speed setting, the drive mechanism <NUM> may be set to operate at an advance speed. The advance speed may be a predetermined speed and/or adjustable speed at which the drive mechanism is to operate to rotate the rotational device <NUM> to facilitate passing an obstruction in a patient's vessel.

In some cases, when the speed module <NUM> adjusts the speed setting to a first speed setting, the speed module may automatically initiate movement of the drive mechanism <NUM> at the advance speed to rotate the rotational device <NUM>. Alternatively, an actuation of the knob <NUM> or other actuator in addition to adjustment of the knob <NUM> to a distal or forward configuration may be required to initiate movement of the drive mechanism <NUM>, as discussed for example with respect to <FIG>. Requiring such actuation of the knob <NUM> or other actuator in addition to adjustment of the knob <NUM> to a distal or forward configuration to initiate movement of the drive mechanism <NUM> may allow for a user of the atherectomy system <NUM> to have the knob assembly <NUM> in the advance mode without rotation of the rotational device <NUM>.

<FIG> depicts an example of the advancer assembly <NUM> showing the knob assembly <NUM> in the lock mode. When the knob assembly <NUM> is set to the lock mode from the advance mode, the knob indicator <NUM> of or in communication with the knob <NUM> may have been adjusted in a clockwise direction such that the knob indicator <NUM> is directed upward and/or substantially perpendicular to a longitudinal axis of the advancer assembly <NUM>.

When the knob assembly <NUM> is set to the lock mode, a signal may be initiated such that the braking module <NUM> may receive a signal to adjust a brake setting to a deactivated setting. When the braking module <NUM> is in the deactivated brake setting, the braking assembly <NUM> may disengage the guidewire <NUM> to allow and/or facilitate movement (e.g., rotational and/or longitudinal movement) of the guidewire <NUM> relative to the rotation assembly <NUM> and/or the advancer assembly <NUM>. Further, when the braking module <NUM> is in the deactivated setting, the brake indicator <NUM> may be turned off or otherwise not illuminated, as shown for example in <FIG>, or turned on to indicate the braking module <NUM> is in the deactivated setting.

Further, the signal initiated when the knob assembly <NUM> is set to the lock mode may result in the lock module <NUM> receiving a signal to adjust a lock setting to an activated setting. When the lock module <NUM> is in the activated lock setting, the locking assembly <NUM> may lock the knob assembly <NUM> relative to the housing <NUM> of the advancer assembly <NUM>. Locking the knob assembly <NUM> relative to the housing <NUM> may restrict or prevent movement of the knob <NUM> along the longitudinal slot or opening <NUM> to restrict or prevent longitudinal movement (e.g., advancing or withdrawing) of a rotational device in communication with knob assembly <NUM> with respect to the advancer assembly <NUM>.

Further, the signal initiated when the knob assembly <NUM> is set to the lock mode may result in the speed module <NUM> receiving a signal to adjust a speed setting to a zero (<NUM>) speed setting (e.g., a stop speed setting). When the speed module <NUM> is in the zero (<NUM>) speed setting, the drive mechanism <NUM> may be set to prevent operation of the drive mechanism <NUM> and thus, rotation of the rotational device <NUM>. Accordingly, when the speed module is in the zero (<NUM>) speed setting, the drive mechanism <NUM> may not operate or cause rotation of the rotational device <NUM> even in response to the knob <NUM> or other actuator being actuated to initiate operation of the drive mechanism <NUM> because the drive mechanism <NUM> is set to operate at a zero (o) speed.

<FIG> depicts an example of the advancer assembly <NUM> showing the knob assembly <NUM> in the withdraw mode. When the knob assembly <NUM> is set to the withdraw mode, the knob indicator <NUM> of or in communication with the knob <NUM> may be adjusted in a clockwise direction such that the knob indicator <NUM> is directed toward a proximal end of the advancer assembly <NUM>.

When the knob assembly <NUM> is set to the withdraw mode, a signal may be initiated such that the braking module <NUM> may receive a signal to adjust or maintain a brake setting to or in a deactivated setting. When the braking module <NUM> is in the deactivated brake setting, the braking assembly <NUM> may disengage or be disengaged from the guidewire <NUM> to allow or facilitate movement (e.g., rotational and/or longitudinal movement) of the guidewire <NUM> relative to the rotation assembly <NUM> and/or the advancer assembly <NUM>. Further, when the braking module <NUM> is in the deactivated setting, the brake indicator <NUM> may be turned off or otherwise not illuminated, as shown for example in <FIG>, or turned on to indicate the braking module <NUM> is in the deactivated setting.

Further, the signal initiated when the knob assembly <NUM> is set to the withdraw mode may result in the lock module <NUM> receiving a signal to adjust a lock setting to a deactivated setting. When the lock module <NUM> is in the deactivated lock setting, the locking assembly <NUM> may unlock the knob assembly <NUM> relative to the housing <NUM> of the advancer assembly <NUM>. Unlocking the knob assembly <NUM> relative to the housing <NUM> may allow for movement of the knob <NUM> along the longitudinal slot or opening <NUM> to advance and/or withdraw the rotational device <NUM> in communication with knob assembly <NUM> with respect to the advancer assembly <NUM>. In some cases, tick marks or other indicia along the longitudinal slot or opening <NUM> may indicate to a user how far the rotational device has traveled as the knob <NUM> adjusts longitudinally.

Further, the signal initiated when the knob assembly <NUM> is set to the withdraw mode may result in the speed module <NUM> receiving a signal to adjust a speed setting to a second speed setting (e.g., a withdraw speed setting). When the speed module <NUM> is in the second speed setting, the drive mechanism <NUM> may be set to operate at a withdraw speed. The withdraw speed may be a predetermined speed and/or adjustable speed at which the drive mechanism is to operate to rotate the rotational device <NUM> to withdraw the rotational device <NUM> within the vessel of the patient. In some cases, the second speed setting or withdraw speed setting may be a lower speed than the first speed setting or advance speed setting. The withdraw speed setting may be configured to facilitate removal of the rotational device <NUM> from the patient's vessel and can be lower than the advance speed setting, as the rotational device <NUM> is not typically trying to burr through an obstruction in the patient's vessel when the knob assembly <NUM> is in the withdraw mode. In some cases, the withdraw speed setting may be configured to break up friction of the rotation assembly <NUM> with the guidewire <NUM> and/or other friction inhibiting withdrawal of the rotation assembly <NUM>.

Similar to as discussed above with respect to <FIG>, when the speed module <NUM> adjusts the speed setting to a second speed setting, the speed module may automatically initiate movement of the drive mechanism <NUM> at the withdraw speed to rotate the rotational device <NUM>. Alternatively, an actuation of the knob <NUM> or other actuator in addition to adjustment of the knob <NUM> to a proximal or backward configuration may be required to initiate movement of the drive mechanism <NUM>, as discussed for example with respect to <FIG>. Requiring such actuation of the knob <NUM> or other actuator in addition to adjustment of the knob <NUM> to a proximal or backward configuration to initiate movement of the drive mechanism <NUM> may allow for a user of the atherectomy system <NUM> to have the knob assembly <NUM> in the withdraw mode without rotation of the rotational device <NUM>.

<FIG> depicts an example of the advancer assembly <NUM> showing the knob assembly <NUM> in the lock mode. When the knob assembly <NUM> is set to the lock mode from the withdraw mode, the knob indicator <NUM> of or in communication with the knob <NUM> may have been adjusted in a clockwise direction such that the knob indicator <NUM> is directed downward or substantially perpendicular to a longitudinal axis of the advancer assembly <NUM>. Such adjustment of the knob <NUM> to place the knob assembly <NUM> in the lock mode may result in initiating a signal such that the braking module <NUM>, the lock module <NUM>, and/or the speed module <NUM> receive signals to set settings similar to as discussed above with respect to <FIG>. Alternatively or in addition, one or more of the braking module <NUM>, the lock module <NUM>, and/or the speed module <NUM> may receive signals to adjust one or more setting in a manner different than discussed above with respect to <FIG>.

<FIG> depict side views of the drive assembly <NUM> of the atherectomy system <NUM> showing schematic views of an example method of using the atherectomy system <NUM> to advance through a vessel <NUM> of a patient and pass an occlusion <NUM> within the vessel <NUM>, where the vessel <NUM> and the occlusion <NUM> are depicted in cross-section. <FIG> depicts the atherectomy system <NUM> inserted into a patient's vessel <NUM> over the guidewire <NUM>, with the rotational device <NUM> not rotating and proximal of the occlusion <NUM>. <FIG> depicts the atherectomy system <NUM> inserted into the patient's vessel <NUM> over the guidewire <NUM>, with the rotational device <NUM> rotating and being advanced toward the occlusion <NUM>. <FIG> depicts the atherectomy system <NUM> inserted into the patient's vessel <NUM> over the guidewire <NUM>, with the rotational device <NUM> not rotating and advanced through the occlusion <NUM>. <FIG> depicts the atherectomy system <NUM> inserted into the patient's vessel <NUM> over the guidewire <NUM>, with the rotational device <NUM> rotating and being withdrawn from the occlusion <NUM>. <FIG> depicts the atherectomy system <NUM> withdrawn from the patient's vessel <NUM> over the guidewire <NUM>, with the rotational device <NUM> not rotating.

As shown in <FIG>, the drive shaft <NUM>, the rotational device <NUM>, and the elongate member <NUM> of the drive assembly <NUM> have been inserted over the guidewire <NUM> into a vessel <NUM> of a patient to a location proximal of the occlusion <NUM>. Typically, the drive assembly <NUM> may be inserted into the vessel <NUM> while the knob assembly <NUM> is in the lock mode, and when the rotational device <NUM> is located at a target location proximal of the occlusion <NUM>, the knob <NUM> may be rotated such that the knob assembly <NUM> is in an advance mode, as shown in <FIG>. As the knob assembly <NUM> is in the advance mode, the braking module <NUM> may be set to an activated setting, the lock module <NUM> may be set to a deactivated setting, and the speed module <NUM> may be set to an advance speed setting.

As can be seen in <FIG>, the rotational device <NUM> is not rotating even though the knob assembly <NUM> is in the advance mode. As such, actuation of the knob <NUM> may be required to initiate rotation of the rotational device <NUM> based on the advance setting for the drive mechanism <NUM> (not shown in <FIG>) within the housing <NUM> of the advancer assembly <NUM>.

As depicted in <FIG>, the knob <NUM> may be actuated by pressing on or applying a force to a top of the knob <NUM>. Thus, when the knob <NUM> has not been actuated, there may be a distance D1 between an outer surface <NUM> of the housing <NUM> and the top of the knob <NUM>. The knob <NUM> may be biased (e.g., via a spring or other suitable biasing mechanism) to the unactuated state, but this is not required. Although the <FIG> depict actuating the knob <NUM> by applying a force to a top of the knob <NUM>, the knob <NUM> and/or other suitable actuator may be actuated in one or more different suitable manners (e.g., an actuator located elsewhere on the advancer assembly <NUM>) to initiate movement of the drive mechanism <NUM>.

<FIG> depicts the knob assembly <NUM> in the advance mode and the knob <NUM> in an actuated state, with a force (not shown) pressed on or otherwise applied to the top of the knob <NUM> to cause movement of the drive mechanism <NUM> and rotation of the rotational device <NUM> in the direction of rotational arrow <NUM>. When the knob <NUM> is actuated, there may be a distance D2 between the outer surface <NUM> of the housing <NUM> and the top of the knob <NUM>. This distance D2 may be less than the distance D1, but this is not required in all instances.

While the knob <NUM> is actuated and the rotational device <NUM> is rotating based on the advance mode of the drive mechanism <NUM>, the knob <NUM> may be longitudinally advanced along the housing <NUM> in the direction of arrow <NUM>. Advancing the knob <NUM> in the direction of the arrow <NUM> may cause the drive shaft <NUM> and the rotational device <NUM> to advance toward and/or into the occlusion <NUM> in the direction of arrow <NUM> while the rotational device <NUM> is rotating to burr through the occlusion <NUM>.

Once the rotational device <NUM> has crossed the occlusion <NUM>, as depicted in <FIG>, the force pressed on or otherwise applied to the top of the knob <NUM> may be removed and the knob <NUM> may return to unactuated state, where a distance between the outer surface <NUM> of the housing <NUM> and the top of the knob <NUM> is the distance D1.

After crossing the occlusion or at one or more other times, the knob <NUM> may be adjusted such that the knob assembly <NUM> is in the withdraw mode, as depicted in <FIG>. As the knob assembly <NUM> is in the withdraw mode, the braking module <NUM> may be set to the deactivated setting, the lock module <NUM> may be set to the deactivated setting, and the speed module <NUM> may be set to a withdraw speed setting. Further, the knob <NUM> in <FIG> is in an actuated state, with a force pressed on or otherwise applied to the top of the knob <NUM> to cause movement of the drive mechanism <NUM> and rotation of the rotational device <NUM> in the direction of the rotational arrow <NUM> and at a speed associated with the withdraw speed setting of the drive mechanism <NUM>. Alternatively, actuation of the knob <NUM> while the knob assembly <NUM> is in the withdraw mode may cause rotation of the rotational device <NUM> in a direction opposite of the direction of the rotational arrow <NUM>. When the knob <NUM> has been actuated and the rotational device <NUM> is rotating based on the withdraw setting of the drive mechanism <NUM>, the knob <NUM> may be longitudinally withdrawn along the housing in the direction of arrow <NUM>. Axially translating the knob <NUM> in the direction of the arrow <NUM> may cause the drive shaft <NUM> and the rotational device <NUM> to withdraw within the vessel <NUM> in the direction of arrow <NUM> while the rotational device <NUM> is rotating.

The steps of advancing the rotational device <NUM> across the occlusion <NUM> and withdrawing the rotational device <NUM> may be repeated until the occlusion <NUM> has been sufficiently addressed (e.g., partially or fully removed or broken apart). Once, the occlusion <NUM> has been sufficiently addressed, the knob <NUM> may be fully withdrawn along the housing <NUM> and adjusted such that the knob assembly <NUM> is in the lock mode, as depicted in <FIG>. As the knob assembly <NUM> is in the lock mode, the braking module <NUM> may be set to the deactivated setting, the lock module <NUM> may be set to the activated setting, and the speed module <NUM> may be set to a zero (<NUM>) speed setting. Once the knob assembly <NUM> is in the lock mode, the advancer assembly <NUM> may be moved in the direction of arrow <NUM> relative to the vessel <NUM> to withdraw the drive shaft <NUM>, the rotational device <NUM>, and/or the elongate member <NUM> from the vessel <NUM>.

Although not necessarily depicted in the FIGs. , the methods and system described herein may include one or more steps other than those steps described herein and/or the described steps may be performed in one or more other orders, as desired unless expressly indicated otherwise. Moreover, the methods described herein may be repeated during operation of the atherectomy system <NUM> upon request or initiation, continuously, continuously at predetermined intervals, and/or at other times. Additionally, one or more additional medical devices including, but not limited to, a guide catheter, sheath, introducer, a filter, and/or other suitable medical devices not necessarily described or discussed herein may be utilized with the atherectomy system <NUM> to facilitate use of the atherectomy system <NUM> in vasculature of a patient.

Those skilled in the art will recognize that the present disclosure may be manifested in a variety of forms other than the specific embodiments described and contemplated herein. For instance, as described herein, various embodiments include one or more modules described as performing various functions. However, other embodiments may include additional modules that split the described functions up over more modules than that described herein. Additionally, other embodiments may consolidate the described functions into fewer modules.

Claim 1:
An advancer assembly (<NUM>) for an atherectomy device, comprising:
a housing (<NUM>);
a drive mechanism (<NUM>) positioned within the housing (<NUM>);
an actuation mechanism (<NUM>) in communication with the drive mechanism (<NUM>) and accessible from exterior of the housing (<NUM>);
a first operation module;
a second operation module; and
wherein a single adjustment of the actuation mechanism (<NUM>) adjusts a setting of the first operation module of the advancer assembly (<NUM>) and a setting of the second operation module of the advancer assembly (<NUM>),
wherein the first operation module of the advancer assembly (<NUM>) is a speed module (<NUM>) configured to adjust a speed setting of the drive mechanism (<NUM>) between a first non-zero speed setting, a second non-zero speed setting, and a zero speed setting in response to the adjustment of the actuation mechanism (<NUM>), wherein the first non-zero speed setting is associated with a rotational speed for a rotational device (<NUM>) that facilitates advancement of the rotational device (<NUM>) through an obstruction or occlusion in a vessel of a patient and the second non-zero speed setting is associated with a rotational speed for the rotational device (<NUM>) that facilitates withdrawal of the rotational device (<NUM>) within the vessel while mitigating risks of injury to the patient, and
wherein the second operation module of the advancer assembly (<NUM>) is a braking module (<NUM>) configured to activate or deactivate a braking assembly (<NUM>) configured to engage a guidewire (<NUM>) extending through the housing (<NUM>) in response to the adjustment of the actuation mechanism (<NUM>).