Patent Publication Number: US-11648029-B2

Title: Devices and methods for removal of material in a vasculature

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of U.S. patent application Ser. No. 17/535,361, filed Nov. 24, 2021, now U.S. Pat. No. 11,376,035, which is a continuation of International Application No. PCT/US2021/016886, filed Feb. 5, 2021, which claims priority to U.S. Provisional Patent No. 62/971,424, filed Feb. 7, 2020 and U.S. Provisional Patent No. 63/036,091, filed Jun. 8, 2020, the contents of each of which are hereby incorporated by reference in their entireties. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates generally to devices and methods for removal of material in a vasculature. More particularly, the present disclosure relates to devices and methods combining suction through a catheter and rotation of a catheter to remove material in a vasculature. 
     BACKGROUND 
     Endoscopic interventions may be performed in the lower extremity due to blockages in the vasculature such as chronic total occlusions, long lesions, and focal lesions. These interventions often occur in the femoral popliteal or infra popliteal vasculature. Physicians will treat these conditions using percutaneous transluminal angioplasty (PTA), stenting, and/or atherectomy devices. Often times the thrombus, clot, and distal emboli involved in these interventional procedures needs to be removed. A need exists for removal of material from a vasculature. 
     BRIEF SUMMARY 
     According to an embodiment, a device for removing material from a vasculature may include a catheter having a lumen, a proximal end, and a distal tip; a proximal rotating element coupled to the proximal end of the catheter, the proximal rotating element configured to rotate the catheter; and a negative pressure element configured to create a controlled suction within a chamber of the device to remove the material from the vasculature, wherein the distal tip of the catheter rotates to assist in removal of the material from the vasculature, and wherein the negative pressure element and the chamber remain stationary during rotation of the proximal rotating element and the catheter. 
     According to an embodiment, the proximal rotating element may include a trigger configured to generate a linear motion; and an actuation system configured to translate the linear motion into a rotational motion, the rotational motion configured to rotate the catheter. 
     According to an embodiment, the trigger may include a lever, a high pivot point trigger, or a low pivot point trigger. 
     According to an embodiment, the actuation system may include a rack, a pinon gear, and a crown gear. 
     According to an embodiment, the actuation system may include a linkage, a half-moon gear, and a crown gear. 
     According to an embodiment, the actuation system may include a linkage, a cam, and a cam follower. 
     According to an embodiment, the actuation system may include a cable, a pulley, a spindle, and a return spring. 
     According to an embodiment, the actuation system may include a gear set, a helix, and a pair of shuttles. 
     According to an embodiment, the actuation system may include a gear set, a constant force spring, and a one-way locking bearing. 
     According to an embodiment, the actuation system is separated from a liquid flow path configured to contain the material being removed from the vasculature. 
     According to an embodiment, the device may include a rotational seal, the rotational seal configured to allow the negative pressure element to remain stationary during rotation of the proximal rotating element and the catheter. 
     According to an embodiment, the proximal rotating element may be configured to alternately rotate the catheter in a clockwise and counter-clockwise direction. 
     According to an embodiment, the proximal rotating element and the catheter may rotate in a first direction upon depression of a trigger and rotate in a second, opposite direction upon release of the trigger. 
     According to an embodiment, the negative pressure element may include a valve configured to control the suction in the chamber; and a locking plunger. 
     According to an embodiment, the negative pressure element may include a bellows; and a spring-biased piston. 
     According to an embodiment, the negative pressure element may include a suction barb. 
     According to an embodiment, the device may include a surface feature on an outer surface of the catheter, the surface feature configured to scrape an interior wall of the vasculature. 
     According to an embodiment, a method for removing material from a vasculature may include applying an external pressure cuff distal to a location for treatment; inserting a catheter into the vasculature and locating a distal tip of the catheter at the location for treatment; creating a suction within a chamber of a device; rotating the distal tip of the catheter; and suctioning material from the vasculature through a lumen of the catheter and into the chamber of the device, wherein rotating the distal tip of the catheter assists in removal of the material from the vasculature, and wherein the chamber remains stationary during rotation of the distal tip of the catheter. 
     According to an embodiment, applying the external pressure cuff distal to the location for treatment may create a dam within the vasculature preventing flow distally from the cuff. 
     According to an embodiment, creating the suction within the chamber of the device may include closing a valve and withdrawing a plunger from the chamber, thus creating a suction force within the chamber and then opening the valve to suction the material from the vasculature, through the lumen of the catheter, and into the chamber. 
     According to an embodiment, the device may allow for creation of a controlled suction. 
     According to an embodiment, rotating the distal tip of the catheter may include repeatedly depressing and releasing a trigger to cause continual rotation of the catheter. 
     According to an embodiment, rotating the distal tip of the catheter may alternate between rotation in a clockwise and counter-clockwise direction. 
     According to an embodiment, the method may include performing an interventional procedure in the vasculature, wherein the material is debris caused by the interventional procedure. 
     According to an embodiment, a device for removing material from a vasculature may include a catheter having a lumen, a proximal end, and a distal tip; an actuation system coupled to the proximal end of the catheter, the actuation system configured to rotate the catheter; and a locking syringe configured to create a controlled suction within a lumen of the device to remove the material from the vasculature, wherein the distal tip of the catheter rotates to assist in removal of the material from the vasculature, and wherein the locking syringe remains stationary during rotation of catheter. 
     According to an embodiment, the actuation system comprises a trigger, a helix gear, a gear/drive, a helix, a drive shuttle a free shuttle and a compression spring. 
     According to an embodiment, the device further comprising a slip ring, the slip ring configured to reduce friction between the compression spring and the drive shuttle. 
     According to an embodiment, the actuation system is configured to translate linear motion of a trigger into rotation motion of gears and the catheter. 
     According to an embodiment, a valve, the valve configured to allow flow from the lumen into the locking syringe and prevent flow from the locking syringe into the lumen. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
       The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate preferred embodiments of the invention and together with the detailed description serve to explain the principles of the invention. In the drawings: 
         FIG.  1    shows an exemplary device, according to an embodiment of the present disclosure. 
         FIG.  2    shows a cross-sectional view of the exemplary device of  FIG.  1   , according to an embodiment of the present disclosure. 
         FIGS.  3 A- 3 C  show an exemplary method employing a device, according to an embodiment of the present disclosure. 
         FIG.  4    shows an exemplary device, according to an embodiment of the present disclosure. 
         FIG.  5    shows a cross-sectional view of the exemplary device of  FIG.  4   , according to an embodiment of the present disclosure. 
         FIG.  6 A  shows an exemplary device, according to embodiments of the present disclosure. 
         FIG.  6 B  shows an exemplary device, according to embodiments of the present disclosure. 
         FIG.  6 C  shows an exemplary device, according to embodiments of the present disclosure. 
         FIG.  7    shows an exemplary device, according to an embodiment of the present disclosure. 
         FIG.  8    shows a cross-sectional view of the exemplary device of  FIG.  7   , according to an embodiment of the present disclosure. 
         FIG.  9    shows an exemplary device, according to an embodiment of the present disclosure. 
         FIG.  10    shows a cross-sectional view of the exemplary device of  FIG.  9   , according to an embodiment of the present disclosure. 
         FIGS.  11 A- 11 F  show exemplary catheter tips for use in a device, according to an embodiment of the present disclosure. 
         FIG.  12    shows a method, according to an embodiment of the present disclosure. 
         FIG.  13    shows an exemplary device, according to an embodiment of the present disclosure. 
         FIG.  14    shows a cross-sectional view of the exemplary device of  FIG.  13   , according to an embodiment of the present disclosure. 
         FIG.  15    shows an exemplary device, according to an embodiment of the present disclosure. 
         FIG.  16    shows a cross-sectional view of the exemplary device of  FIG.  15   , according to an embodiment of the present disclosure. 
         FIG.  17    shows a cross-sectional view of an exemplary device, according to an embodiment of the present disclosure. 
         FIG.  18    shows a side view of the syringe and actuation device of  FIG.  17   , according to an embodiment of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     The present disclosure relates to devices and methods of suctioning material through a catheter and rotating the catheter to assist in removal of the material. In an example method, the device is used in conjunction with an external cuff placed distal to the location of an interventional procedure to be performed and/or distal to the location of the device in the vasculature. The cuff occludes the vasculature. The distal end of the catheter is placed in the vasculature near the dam caused by the external cuff. Using rotation of the catheter and suction through the catheter, material is removed from the vasculature through the device. The material may be debris caused by an interventional procedure and/or may be other material (e.g., blood clot, occlusion) located in the vasculature. In example devices, actuation systems are provided that convert the linear motion caused by pulling a handle trigger to a rotational motion of the distal tip of the catheter. Such linear motion conversion may be achieved with gears, cams, and/or cables. The device may allow for controlled suction through the catheter. 
     Referring to  FIGS.  1  and  2   , an exemplary device  10  is shown. Device  10  has a configuration to allow for suction and spinning of a catheter  60  and generally includes a handle  14  with a trigger  18 , a plunger  24 , and an actuation system  48 . The device  10  may include a lateral portion  12  and the handle  14 . The lateral portion  12  and handle  14  may have a housing  16 . The housing  16  may be a unitary housing or may comprise more than one housing portion coupled together. The lateral portion  12  and the handle  14  may be formed together as a single, unitary component or may be formed as separate components coupled together. 
     The catheter  60  may be a hollow, cylindrical catheter having a lumen. The catheter  60  may be sized in both diameter and length based on the particular vasculature being treated, the procedure being performed, or both. The catheter  60  may have a proximal end coupled to the actuation system  48  with a coupling  58 . The catheter  60  may have a distal end. The distal end may be placed proximate the location to be treated in the vasculature during use of the device  10 . The distal end may include an opening into the lumen of the catheter  60 . In some examples, the distal end of the catheter  60  may be equipped with a distal tip structure, such as shown and described in  FIGS.  11 A- 11 F . 
     The catheter  60  and/or device  10  may be further configured to contact the vasculature to loosen, scrape or otherwise contact impediments that exist in a targeted area. In an example, the catheter  60  may include a surface feature on the outer surface of the catheter. The surface feature may provide an abrasive outer surface to the catheter  60 . The surface feature may be, for example, but not limited to, a coating, profile, protrusions, texture, roughened surface, etc. The catheter  60  may have a pipe cleaner type of outer characteristic. The catheter  60  may have a roughened outer surface. The outer surface of the catheter  60  may act as an agent that would lightly scrape the walls of the vasculature to loosen any impediments or loose impediments on the wall of the vasculature as the catheter  60  is rotated and/or translated longitudinally through the vasculature. Other parts of the device  10  may also be configured to accomplish this functionality. 
     The handle  14  may include the trigger  18  and a biasing member  20  ( FIG.  2   ). The trigger  18  may be biased outward with respect to the handle  14  by the biasing member  20 . Alternatively, the trigger  18  may be biased inward. The trigger  18  may be biased to a rest or inactive position. The biasing member  20  may be a spring, such as a coil spring, although other biasing devices are contemplated. The biasing member  20  may begin in a neutral state to be compressed by the trigger  18  during actuation of the device  10 . When force is released from the trigger  18 , the compressed biasing member  20  may extend back to the neutral state. 
     Referring to  FIG.  2   , the lateral portion  12  may include a chamber  22  and the plunger  24 . The chamber  22  may be a hollow chamber, such as, for example, a hollow, cylindrical chamber. Other shapes of the chamber  22  are contemplated. The chamber  22  may include a window  26 . The window  26  may allow for viewing, measuring, and/or monitoring of material to be collected in the chamber  22 . The window  26  may be located on a side surface of the device  10 , however alternative locations, such as, for example, the top or alternate side of the device  10  are consider. In an embodiment, the window  26  may extend around several sides of the device in a semi-cylindrical or cylindrical manner. The window  26  may include marks  28 . The chamber  22  may include a lock  30  extending from an inner wall of the chamber  22 . The lock  30  may extend downward from an inner, upper surface of the chamber  22 , although other locations are contemplated. Although depicted as a triangular cross-section or generally trapezoidal or frustoconical shape, the lock  30  may have any shape. The shape of the lock  30  may mate, conform, or correspond to the shape of one or more notches  32  on the plunger  24 . Although depicted and described as a lock and notch arrangement, other devices or arrangements that prevent relative movement of the plunger  24  with respect to the chamber  22  may be contemplated. 
     The plunger  24  may be cylindrical, although other shapes of the plunger  24  are contemplated. The plunger  24  may have a perimeter or shape that corresponds, conforms, or mates with an internal surface or shape of the chamber  22 . For example, the chamber  22  may be a hollow cylinder and the plunger  24  may be a cylinder. In this manner, the plunger  24  may be adapted to move with respect to the chamber  22 . The plunger  24  may include one or more notches  32 . The one or more notches  32  may be located on the plunger  24  such that the one or more notches  32  may be selectively aligned with the lock  30 . For example, where the lock  30  extends downward from an inner, upper surface of the chamber  22 , the one or more notches  32  may extend downward form an outer, upper surface of the plunger  24 . The one or more notches  32  may be openings, grooves, slots, indentations, or other shapes formed within the body of the plunger  24 . The one or more notches  32  may be a single notch or groove that extends along the surface of the plunger  24 . The one or more notches  32  may be a helical groove. The one or more notches  32  may be spaced along the plunger  24  to correspond to a volume or degree of vacuum allowed in the chamber  22 . The plunger  24  may include a forward end  34  and a rear end  35 . The forward end  34  may have an outer diameter that seals with an inner diameter of the chamber  22 . The rear end  35  may allow for a user to push or pull or otherwise move the plunger  24  with respect to the chamber  22 . 
     The lateral portion  12  may include a valve  36  and a valve  38 . The valve  36  may be a manual stop valve. A user may rotate a knob  40  of the valve  36  to open and/or close the valve  36 . The valve  36  may be opened and closed in an incremental fashion such that there exists partially opened or partially closed positions of the valve  36 . Each turn of the knob  40  may open or close the valve  36  a predetermined degree. The valve  36  may be a ball valve. For example, the knob  40  may rotate a shaft  42  that rotates a ball  44 . The ball  44  may have an opening therethrough. Rotation of the knob  40  may align, partially align, and/or misalign the opening of the ball  44  with a lumen, such as, for example, the lumen  46 . The valve  38  may be a one-way valve. The valve  38  may permit fluid to flow from the lumen  46  into the chamber  22  but prohibit or prevent fluid from flowing from the chamber  22  to the lumen  46 . 
     The lateral portion  12  may include the actuation system  48 . The actuation system  48  may allow the trigger  18  to actuate a corresponding effect in a catheter, as will be described in more detail to follow. The actuation system  48  may include a rack  50 , a pinion gear  52 , and a crown gear  54 . An interface  56 , such as, for example, a rotational seal, may be located along the lumen  46  between the actuation system  48  and the valve  36 . The interface  56  may allow the actuation system  48  to rotate without also rotating the valves  36  and  38 . The interface  56  may prevent the chamber  22 , plunger  24 , valve  36 , valve  38 , and trigger  18  from rotating with the pinion gear  52 , crown gear  54 , and catheter  60 . The rack  50  may be operably coupled to the trigger  18 . The rack  50  may be integral or unitarily formed with the trigger  18 . A coupling  58  may couple the actuation system  48  to a catheter  60 . Thus, the actuation system  48  may impart a function, such as, for example, a rotational movement, on the catheter  60 . The lumen  46  may extend from the catheter  60 , through the coupling  58 , crown gear  54 , pinion gear  52 , interface  56 , valve  36 , and valve  38 . In this manner, material (e.g., fluid, debris, solid particles, etc.) may be transmitted from a lumen of the catheter  60  into the chamber  22  via the lumen  46 . 
     The rack  50 , pinion gear  52 , and crown gear  54  may be selected based on the desired degree of rotation based on each depression of the trigger  18 . The crown gear  54  may be a reduction gear. The crown gear  54  may be sized to achieve a desired number of rotations of the catheter  60  per actuation of the trigger  18 . The smaller the crown gear  54 , the more rotations of the catheter  60  may be achieved per actuation of the trigger  18 . The coupling  58  may be a standard luer lock for coupling the catheter  60  to the device  10 . 
     In operation, an interventional procedure may be performed within a vasculature of patient, such as, for example, an artery of a lower extremity of the patient as depicted in  FIGS.  3 A- 3 C . Other uses are contemplated, including, for example, arms or any appendage. For example, the user may remove, destroy or otherwise break-up a blockage or obstruction in the vasculature during a previously or concurrently performed interventional procedure. For example, the interventional procedure may include, but is not limited to, thrombectomy, atherectomy, stenting, balloon angioplasty, and other processes to recannulate a vessel. Although described in conjunction with an interventional device, in an exemplary use, the device may be used alone, not in conjunction with a separate interventional procedure/device. That is, for example, the device may perform the interventional procedure. For example, the device may remove material, such as, for example, but not limited, to a clot, within the vasculature. 
     Referring to  FIGS.  3 A- 3 C , an external cuff  62  may be placed distal to the location  64  of the material to be removed (e.g., distal to the location of an interventional procedure and/or distal to the location within the vasculature where the device is employed). The external cuff  62  may create a dam, blockage, or occlusion within the vasculature  66  such that material disturbed during use of the device (and/or during the interventional procedure, if applicable) may not flow in the vasculature  66  past the location of the external cuff  62 . The external cuff  62  may be a cuff placed around the external surface of the patient. In the example where the device is employed in a lower extremity of the patient, the external cuff may be placed around the external surface of the lower extremity distal to the location where the distal end of the catheter of the device is placed and/or distal of the interventional procedure (e.g., around the outside of the leg as shown in  FIG.  3 A ). 
     The external cuff  62  may operate as a tourniquet or cuff to restrict flow within the vasculature  66 . The external cuff  62  may restrict flow in the vasculature  66  distal to the location of the cuff  62 . The restriction of flow due to the cuff  62  may create a dam within the vasculature  66 . The external cuff  62  may allow for monitoring and/or adjustment during the procedure (e.g., during use of the device of the present disclosure). The external cuff  62  may allow for adjustment of the pressure and/or flow within the vasculature. That is, after placement of the external cuff  62  on the patient, a medical professional may monitor the blood pressure within the vasculature being treated and adjust the pressure applied by the cuff  62  as necessary throughout the duration of the procedure (and/or use of the device  10 ). This may allow for the medical professional to control the restriction of flow distal to the cuff  62 . If pressure within the vasculature increases, for example, the medical professional may adjust the cuff  62  accordingly to ensure the restriction of flow distal to the cuff is maintained. 
     The interventional procedure may occur prior to use of the device  10  or concurrently therewith. The interventional procedure may occur prior to insertion of the catheter  60 , after insertion of the catheter  60 , or concurrently therewith. In some examples, no interventional procedure may be performed and the device  10  may be employed to perform the interventional procedure with no other devices or systems. For example, in  FIG.  3 B , the interventional procedure may be performed after installation of the cuff  62 , but before use of the device  10 . In the case of  FIG.  3 B , the interventional procedure may be an atherectomy. Although, as discussed, other procedures are contemplated and the device  10  may be used alone, not in conjunction with an interventional procedure/device. In  FIG.  3 B , the interventional procedure may use an interventional device  68  that breaks up or disturbs an obstruction  70 . Such a break up or destruction of the obstruction  70  may cause debris  72 . 
     In use of the device  10  (or any of the devices described herein), a user may insert the catheter  60  in the vasculature  66  of the patient, as shown in  FIG.  3 C . A distal end  74  of the catheter  60  may be located near the location  64  of and upstream of the dam created by the external cuff (This may also be a location near the location of an interventional procedure, if applicable). The device  10  may suction or vacuum material (e.g., debris  72 ) from the location  64  of the distal end  74  of the catheter  60  through the distal end  74  of the catheter  60 , up through a lumen of the catheter  60 , and into the chamber  22  of the device  10 . If an interventional procedure is also performed, the suctioning may occur simultaneously with the interventional procedure, after completion of the interventional procedure, or a combination thereof. The catheter  60  may rotate before, after, or simultaneously with the suctioning of material. Rotation of the catheter  60  may create turbulent flow which may facilitate entry of the material and fluid (e.g., blood) into the lumen of the catheter  60 . Rotation of the catheter  60  may create a vortex at the distal top of the catheter  60  to upend the material. Rotation of the catheter  60  may agitate material, prevent or prohibit material from settling in any one location with the vasculature, and/or suspend the material within the fluid in the vasculature. This may enhance or promote the removal of material from the vasculature. 
     Referring to  FIGS.  1 ,  2 , and  3 C , during use, the device  10  begins with the valve  36  in a closed position. The user inserts the catheter  60  into the vasculature being treated. Once at the desired location within the vasculature (e.g., a location near or within the dam created by the external cuff), the user may move the plunger  24  rearward (e.g., to the left in  FIG.  2   ) with respect to a front end of the device  10 . The user may rotate the plunger  24  such that a notch  32  aligned with the lock  30  is moved out of alignment. The user may then slide or pull the plunger  24  rearward. The lock  30  may not interfere with the outer surface of the plunger  24  during movement. When the desired position of the plunger  24  is achieved, the user may rotate the plunger  24  such that one of the notches  32  is in alignment with the lock  30 . This may prevent the plunger  24  from moving with respect to the chamber  22  during use of the device  10 . The lock  30 , when engaged, may prevent the vacuum within the chamber  22  from pulling the plunger  24  into the chamber  22 . 
     The user may select the appropriate notch  32  to align with the lock  30  based on the desired vacuum, based on a desired amount of material to be collected in the chamber  22 , or a combination thereof. Each notch  32  may align with a predetermined vacuum force or chamber volume, or both, that the user may select from. For example, if the user desires a small amount of material to be collected or small vacuum force, the user may select a notch  32  closer to the rear end  35  such that the chamber  22  is reduced as compared to the total available volume of the chamber  22 . If the user desires a large amount of material to be collected or large vacuum force, the user may select a notch  32  closer to the forward end  34  such that the chamber  22  is enlarged to the total volume or closer to the total available volume. Selecting the desired volume and vacuum of the chamber  22  may allow for the device to perform a controlled suction at the distal end of the catheter  60  within the vasculature. 
     Once the plunger  24  is in the desired location and locked in place, the user may turn the knob  40  to open the valve  36 . Since the plunger  24  is moved with the valve  36  in a closed position a vacuum or negative pressure is created within the chamber  22 . The plunger  24  and the valve  36  may form a negative pressure element. When the valve  36  is opened, material or fluid may be pulled by the negative pressure or vacuum in the chamber  22 . That is, fluid and material in the vasculature at the distal end of the catheter  60  may flow through the lumen of the catheter  60 , through the lumen  46  of the device  10 , and into the chamber  22 . A user may watch the amount of fluid and/or material collecting in the chamber  22  through the view window  26 . The graduated marks  28  may allow the user to monitor and record the amount of material and/or fluid collected. The valve  38  may prevent any of the collected materials from traveling back out of the chamber  22 , through the lumen  46  and back into the vasculature of the patient. 
     The suction effect of the device  10  may be operated independently of the rotation of the catheter  60  of the device  10  and vice versa. A user may elect to operate the suction before, after, or concurrently with rotation of the catheter  60 . To rotate the catheter  60 , the user may depress the trigger  18  against the force of the biasing member  20 . As the trigger  18  is operatively coupled to the rack  50 , depression of the trigger  18  may cause the rack  50  to move rearward (e.g., to the left in  FIG.  2   ). The rack  50  may have teeth or other members which engage or interact with teeth or other members on the pinion gear  52 . The teeth or members on the pinion gear  52  may also interact with teeth or other members on crown gear  54 . Movement of the rack  50  may thus cause rotation of the pinion gear  52  which may further cause rotation of the crown gear  54 . A coupling  58  couples the crown gear  54  to the catheter  60 . Thus, rotation of the crown gear  54  causes rotation of the catheter  60 . Although the actuation system  48  is described as a series of gears, any actuation system which converts the linear motion of the trigger  18  to rotational movement of the catheter  60  is contemplated. 
     The rack  50  may allow for 360° rotation of the pinion gear  52 . Alternatively, the rack  50  may allow for a fraction of 360° rotation, such as, for example, 180° rotation, 90° rotation, 270° rotation, or anywhere between 0° rotation and 360° rotation. For example, the rack may be sized such that actuation of the rack  50  along the pinion gear  52  may allow for only partial rotation of the pinion gear  52 . The rack  50  and trigger  18  may not allow for continuous spinning of the catheter  60 . For example, the trigger  18  and rack  50  may be sized and arranged such that a single pull of the trigger  18  moves the rack  50  a discrete distance along the pinion gear  52 . Additional pulls of the trigger  18  may thus be required to continue movement of the rack  50  and thus rotation of the pinion gear  52 . Thus, to continue to rotate the catheter  60 , the trigger  18  may be depressed and released continuously to effectuate multiple actuations of the actuation system  48 . Alternatively, continuous rotation of the catheter  60  with a single pull of the trigger  18  may be provided. 
     The device  10  may be arranged such that depressing the trigger  18  effectuates rotation in one direction (e.g., clockwise or counter-clockwise) and release of the trigger  18  and the biasing member  20  pushing the trigger  18  into the normal, rest position may effectuate rotation in the opposite direction (e.g., the opposite of clockwise or counter-clockwise). This effect may be caused by the rack  50  moving backward, causing rotation of the pinion gear  52  in a first direction when the trigger  18  is depressed and the rack  50  moving forward when the biasing member  20  pushes the trigger  18  and thus the rack  50 , causing rotation of the pinion gear  52  in a second direction, opposite to the first direction. The alternation of the direction of rotation of the catheter  60  caused by the alternating rotation of the actuation system  48  may assist in kicking-up or dislodging material near the catheter tip. Alternatively, the device  10  may cause rotation in a single direction, continuous non-stopping rotation in a single direction (e.g., rotation until cessation by a stopping device), and/or continuous non-stopping rotation in multiple directions. 
     Rotation of the catheter  60  before, after, or during suction of the device  10  may assist in dislodging or kicking-up the material near the distal tip of the catheter  60 . This may assist in removing the material from the vasculature. The dam caused by the external cuff may prevent or prohibit material from traveling distal to the location of the distal tip of the catheter  60 . This may assist in ensuring all material is evacuated with the device  10 . Although the above is described with respect to a vasculature (e.g., an artery) of a lower extremity (e.g., a leg) of a patient, the method and device of the present disclosure may be employed in other locations and/or other vessels, such as for example, other limbs or locations of the patient that material may be desired to be removed and/or interventional procedures may be performed. 
     Although the device  10  is described in conjunction with an occluded vasculature, the device  10  may be employed in a vasculature that is not occluded. In an example, the device may be used in a purely thrombectomy procedure. The device  10  may be used in any procedure, whether or not the vasculature is occluded, that may benefit from the rotational and suction capabilities of the device  10 . Additionally, although described in conjunction with an external cuff, the device  10  may be employed in a procedure where no cuff and/or no restriction to the flow in the vasculature is provided. In some examples, restriction to the flow may be provided in other manners than with an external cuff. In some examples, no restriction of flow may be desired. 
     The operational procedure and variations thereof described within the present disclosure may be achieved with any of the devices or any combination of features of the devices described herein. 
       FIGS.  4  and  5    show an exemplary device  100 . The exemplary device  100  may be the same or similar as the device  10  and similar numerals are relied upon to describe like components. Components not described in  FIGS.  4  and  5    may be the same or similar as to like illustrated components in device  10 . The device  100  may be used in the aforementioned method. The device  100  may include a handle  114  and a trigger  118 . The trigger  118  may operate in a scissors action with respect to the handle  114 . The trigger  118  may include a pivot  119 . The pivot  119  may be a pin or other fastener or device which allows for a pivoting action of the trigger  118 . The pivot  119  may be a high pivot point. The pivot  119  may be located within the housing  16 . The pivot  119  may separate or define the trigger  118  into a handle portion  121  and a moment arm  123 . 
     The device  100  may include an actuation system  148 . The actuation system  148  may include a linkage  150 , a half-moon gear  152 , and a crown gear  54 . The linkage  150 , half-moon gear  152 , and crown gear  54  may be selected based on the desired degree of rotation based on each depression of the trigger  118 . The crown gear  54  may be a reduction gear. The crown gear  54  may be sized to achieve a desired number of rotations of the catheter  60  per actuation of the trigger  118 . The smaller the crown gear  54 , the more rotations of the catheter  60  may be achieved per actuation of the trigger  118 . 
     To rotate the catheter  60 , the user may depress the trigger  118 . Biasing member  20  may be in a neutral state when the device  100  is not actuated. Depression of the trigger  118  may extend the biasing member  20 . As the trigger  118  is operatively coupled to the linkage  150 , depression of the trigger  118  may cause the linkage  150  to move forward (e.g., to the right in  FIG.  5   ). The linkage  150  may be coupled at a first end  151  to the trigger  118  and at a second end  153  to the half moon gear  152 . As the linkage  150  moves forward, the half moon gear  152  may rotate. In the example of  FIG.  5   , the rotation of the half moon gear  152  may be counterclockwise. The half-moon gear  152  may have teeth or other members which engage or interact with teeth or other members on the crown gear  54 . Movement of the linkage  150  may thus cause rotation of the half-moon gear  152  which may further cause rotation of the crown gear  54 . A coupling  58  couples the crown gear  54  to the catheter  60 . Thus, rotation of the crown gear  54  causes rotation of the catheter  60 . Although the actuation system  148  is described as a linkage and a series of gears, any actuation system which converts the linear motion of the trigger  118  to rotational movement of the catheter  60  is contemplated. 
     The linkage  150  may allow for full rotation of the half-moon gear  152  (e.g., 180° rotation). Alternatively, the linkage  150  may allow for a fraction of 180° rotation, such as, for example, 90° rotation, 45° rotation, or anywhere between 0° rotation and 180° rotation. The linkage  150  may not allow for continuous spinning of the catheter  60 . Thus, to continue to rotate the catheter  60 , the trigger  118  may be depressed and released continuously to effectuate multiple actuations of the actuation system  148 . The device  100  may be arranged such that depressing the trigger  118  effectuates rotation in one direction (e.g., counter-clockwise as shown in  FIG.  5   ) and release of the trigger  118 , and the biasing member  20  moving from the extended, actuated state to the neutral, rest state pulling the trigger  118  into the normal, rest position may effectuate rotation in the opposite direction (e.g., clockwise). This effect may be caused by the linkage  150  moving forward, causing rotation of the half-moon gear  152  in a first direction when the trigger  118  is depressed and the linkage  150  moving backward when the biasing member  20  pulls the linkage  150 , causing rotation of the half-moon gear  152  in a second direction, opposite to the first direction. The alternation of the direction of rotation of the catheter  60  caused by the alternating rotation of the actuation system  148  may assist in kicking-up or dislodging material near the catheter tip. Alternatively, the device  100  may cause rotation in a single direction, continuous non-stopping rotation in a single direction (e.g., rotation until cessation by a stopping device), and/or continuous non-stopping rotation in multiple directions. 
       FIGS.  6 A- 6 C  show exemplary devices  200   a ,  200   b , and  200   c , respectively. The device  200   a  of  FIG.  6 A  may include a handle  214   a  and a trigger  218   a . The handle  214   a  may be a main handle that is cored out. The trigger  218   a  may be a lever handle that fits inside the cored-out portion of the handle  214   a . This may allow for maximized travel of the trigger, resulting in a greater or maximized degree of rotation of the gears and, in turn, a greater rotation of the catheter (not shown) per actuation of the trigger  218   a . The device  200   b  of  FIG.  6 B  may include a handle  214   b  and a trigger  218   b . The handle  214   a  may be a paddle handle. The trigger  218   b  may be a blade-type trigger that recesses into the handle  214   b . The device  200   b  may include a window  226   b  that is open on a top surface of the device  200   b . The device  200   c  of  FIG.  6 C  may include a handle  214   c  and a trigger  218   c . The trigger  218   c  may be a full loop handle. In each of the devices  200   a ,  200   b , and  200   c , the triggers may include high pivot points to enable actuation of the actuating system, such as actuation system  148  of  FIG.  5   . Thus, any of the example devices of  FIGS.  6 A- 6 C  may be used with the features of the device  100  or any of the devices described herein. 
       FIGS.  7  and  8    show an exemplary device  300 . The exemplary device  300  may be the same or similar as the device  10  and similar numerals are relied upon to describe like components. Components not described in  FIGS.  7  and  8    may be the same or similar as to like illustrated components in device  10 . The device  300  may be used in the aforementioned method. The device  300  may include a handle  314  and a trigger  318 . The trigger may include a pivot  319 . The pivot  319  may be a pin or other fastener or device which allows for a pivoting action of the trigger  318 . The pivot  319  may be a low pivot point. The pivot  319  may be located within the handle  314 . 
     The device  300  may include a valve  336 . The valve  336  may be a push release valve. The valve  336  may include a button  340 , a shaft  341 , a biasing member  343 , and a valve member  345 . The valve  336  may be biased to a normally closed position. That is, the valve member  345  may be biased by the biasing member  343  to obstruct the lumen  46  of the device  300 . To open the valve  336 , a user may depress the button  340  against the force of the biasing member  343  such that the shaft  341  moves the valve member  345  into a space  347  located adjacent to the lumen  46 , thus permitting flow from the lumen  46  through the one-way valve  38  and into the chamber  22 . To close the valve  336 , the user may depress the button  340 . A latch or lock may hold the button  340  and thus the valve  336  in the open and/or closed position. 
     The device  300  may include a bellows  324 . The bellows  324  may be coupled to a shaft  325  and piston  327 . A biasing member  329  may also be included. The shaft  325 , piston  327 , and biasing member  329  may be located within the chamber  22 . To remove air from the chamber  22  to create the vacuum or negative pressure in the chamber, a user may pump or repeatedly press the bellows  324  to evacuate the air from the chamber  22  out of an opening in a distal end of the bellows (not visible). The opening may be a one-way opening that permits removal of air from the chamber  22  but does not allow air to travel through the bellows  324  and into the chamber  22 . Pressing the bellows  324  inward (e.g., to the right in  FIG.  8   ), extends the shaft  325 , piston  327 , and biasing member  329  into the chamber  22 . When the bellows  324  is released, the biasing member  329  may move from the extended position to the neutral position. This action may cause the piston  327  to pull air out of the chamber  22  through the opening in the bellows  324 . Repeated actuation of the bellows operates the system as a pump to remove air from the chamber  22  and create a vacuum therein. As in prior examples, the valve  336  is closed during the creation of the vacuum in the chamber  22 . 
     The device  300  may include an actuation system  348 . The actuation system  348  may include a linkage  350 , a cam  352 , and a cam follower  354 . The linkage  350 , cam  352 , and cam follower  354  may be selected based on the desired degree of rotation based on each depression of the trigger  318 . The cam  352  and cam follower  354  may be sized to achieve a desired number of rotations of the catheter  60  per actuation of the trigger  318 . 
     To rotate the catheter  60 , the user may depress the trigger  318 . Biasing member  20  may be in a neutral state when the device  300  is not actuated. Depression of the trigger  318  may extend the biasing member  20 . As the trigger  318  is operatively coupled to the linkage  350 , depression of the trigger  318  may cause the linkage  350  to move forward (e.g., to the right in  FIG.  8   ) The linkage  350  may be coupled at a first end  351  to the trigger  318  and at a second end  353  to the cam  352 . As the linkage  350  moves forward, the cam  352  may rotate. In the example of  FIG.  8   , the rotation of the cam  352  may be counterclockwise. The cam  352  may have a profile or shape which mates, engages or interacts with a profile or shape of the cam follower  354 . Movement of the linkage  350  may thus cause rotation of the cam  352  which may further cause rotation of the cam follower  354 . A coupling  58  couples the cam follower  354  to the catheter  60 . Thus, rotation of the cam follower  354  causes rotation of the catheter  60 . Although the actuation system  348  is described as a linkage and cam arrangement, any actuation system which converts the linear motion of the trigger  318  to rotational movement of the catheter  60  is contemplated. 
     The linkage  350  may allow for full rotation of the cam  352  (e.g., 360° rotation). Alternatively, the linkage  350  may allow for a fraction of 360° rotation, such as, for example, 180° rotation, 270° rotation, 90° rotation, 45° rotation, or anywhere between 0° rotation and 360° rotation. The linkage  350  may not allow for continuous spinning of the catheter  60 . Thus, to continue to rotate the catheter  60 , the trigger  318  may be depressed and released continuously to effectuate multiple actuations of the actuation system  348 . The device  300  may be arranged such that depressing the trigger  318  effectuates rotation in one direction (e.g., counter-clockwise as shown in  FIG.  8   ) and release of the trigger  318 , and the biasing member  20  moving from the extended, actuated state to the neutral, rest state pulling the trigger  318  into the normal, rest position may effectuate rotation in the opposite direction (e.g., clockwise). This effect may be caused by the linkage  350  moving forward, causing rotation of the cam  352  in a first direction when the trigger  318  is depressed and the linkage  350  moving backward when the biasing member  20  pulls the linkage  350 , causing rotation of the cam  352  in a second direction, opposite to the first direction. The alternation of the direction of rotation of the catheter  60  caused by the alternating rotation of the actuation system  348  may assist in kicking-up or dislodging material near the catheter tip. Alternatively, the device  300  may cause rotation in a single direction, continuous non-stopping rotation in a single direction (e.g., rotation until cessation by a stopping device), and/or continuous non-stopping rotation in multiple directions. 
       FIGS.  9  and  10    show an exemplary device  400 . The exemplary device  400  may be the same or similar as the device  10  and similar numerals are relied upon to describe like components. Components not described in  FIGS.  9  and  10    may be the same or similar as to like illustrated components in device  10 . The device  400  may be used in the aforementioned method. The device  400  may include a handle  414  and a trigger  418 . The trigger may include a pivot  419 . The pivot  419  may be a pin or other fastener or device which allows for a pivoting action of the trigger  418 . The pivot  419  may be a low pivot point. The pivot  419  may be located within the handle  414 . 
     The device  400  may include a pressure release  436 . The pressure release  436  may be a thumb actuated pressure release. The pressure release  436  may be a single hand actuation. The pressure release  436  may be biased to a closed position. The pressure release  436  may be a normally closed valve. In an embodiment, the pressure release  436  may be the same or similar as the valve  336  of  FIG.  8   . The pressure release  436  may be a wheel or other rotating member. The pressure release  436  may include an opening in a portion thereof that extends through the pressure release  436 . When the opening is aligned with the lumen  46 , fluid may be allowed to flow through the catheter  60 , lumen  46  and out of the device  400  via a barb  424 . When the opening is misaligned with the lumen  46 , that is, when a solid portion of the pressure release  436  is aligned in the lumen  46  blocking the pathway, no fluid may be allowed to flow through the lumen  46 . 
     The device  400  may include a barb  424 . The barb  424  may be a suction barb, such as a wall suction barb. The barb  424  may allow for coupling the device  400  to a supplied suction (not shown). Thus, barb  424  may allow for suction when the supplied suction (e.g., via a vacuum device) is applied to barb  424 . In some examples, the on-demand suction may occur whenever the device is turned on and off as suction is needed and the pressure release  436  may be held in the open position. In some examples, the on-demand suction may occur when the device is held in an on position and the pressure release  436  is opened and closed when suction is desired. 
     The device  400  may include an actuation system  448 . The actuation system  448  may include a cable drive system. The actuation system  448  may include a cable  450 , a post  451 , a spindle  452 , and a return spring  453 . A cable assist  455  may optionally be provided. The post  451  may be a pully or device that allows for force to be transferred from the pull of the trigger  418  to the spindle  452 . The spindle  452  may be a wheel. The spindle  452  and/or the cable  450  may be selected based on the desired degree of rotation based on each depression of the trigger  418 . The spindle  452  may be sized to achieve a desired number of rotations of the catheter  60  per actuation of the trigger  418 . The number of rotations per pull of the trigger  418  may be directly correlated to the diameter of the spindle  452 . The cable  450  may be wrapped around a groove or depression in the outer diameter of the spindle  452 . In an example, the cable  450  may be wrapped multiple times around the outer diameter of the spindle  452  to allow for multiple rotations of the catheter  60  per pull of the trigger  418 . 
     To rotate the catheter  60 , the user may depress the trigger  418 . As the trigger  418  is operatively coupled to the cable  450 , depression of the trigger  418  may cause the cable  450  to move rearward (e.g., to the left in  FIG.  10   ). The cable  450  may be coupled at a first end  439  to the trigger  418  and at a second end  457  to the spindle  452 . The cable  450  may extend around the post  451  at a position between the first end  439  and the second end  457 . As the cable moves rearward, the spindle  452  may rotate until the cable  450  is no longer wrapped around the outer diameter of the spindle  452 . Movement of the cable  450  may thus cause rotation of the spindle  452 . A coupling  58  couples the spindle  452  to the catheter  60 . Thus, rotation of the spindle  452  causes rotation of the catheter  60 . Although the actuation system  448  is described as cable arrangement, any actuation system which converts the linear motion of the trigger  418  to rotational movement of the catheter  60  is contemplated. When the trigger  418  is no longer depressed, the return spring  453  may rotate the spindle  452  back to a rest or neutral position. This may cause the cable  450  to wrap around the outer diameter of the spindle  452 , pulling the trigger  418  back into the neutral position. The cable assist  455  may be a biasing member that may assist in returning the cable to the neutral position. The return spring  453  may cause the spindle  452  to rotate in an opposite direction as compared to the direction of rotation during actuation of the trigger  418 . 
     The cable  450  may allow for full rotation of the spindle  452  (e.g., 360° rotation). Alternatively, the cable  450  may allow for a fraction of 360° rotation, such as, for example, 180° rotation, 270° rotation, 90° rotation, 45° rotation, or anywhere between 0° rotation and 360° rotation and/or for multiples of rotation of the spindle  452  (e.g., 540° rotation). The cable  450  may not allow for continuous spinning of the catheter  60 . Thus, to continue to rotate the catheter  60 , the trigger  418  may be depressed and released continuously to effectuate multiple actuations of the actuation system  448 . The device  400  may be arranged such that depressing the trigger  418  effectuates rotation in one direction (e.g., clockwise as shown in  FIG.  10   ) and release of the trigger  418 , and the motion of the return spring  453 , may effectuate rotation in the opposite direction (e.g., counter-clockwise). This effect may be caused by the cable  450  moving backward, causing rotation of the spindle  452  in a first direction when the trigger  418  is depressed and the cable  450  moving backward when the return spring  453  pulls the cable  450  back onto the spindle  452 , causing rotation of the spindle  452  in a second direction, opposite to the first direction. The alternation of the direction of rotation of the catheter  60  caused by the alternating rotation of the actuation system  448  may assist in kicking-up or dislodging material near the catheter tip. Alternatively, the device  400  may cause rotation in a single direction, continuous non-stopping rotation in a single direction (e.g., rotation until cessation by a stopping device), and/or continuous non-stopping rotation in multiple directions. 
     FIGS. 11A-11F show various catheter tips for the catheter  60 . The tips  500   a ,  500   b ,  500   c ,  500   d ,  500   e , and  500   f  may be selected based on the desired function of the tip, the particular environment in which the catheter is deployed, the interventional procedure, if any, performed, and the amount of force needed at the distal tip to dislodge the material. The tip  500   a  may be a chiseled tip. The tip  500   b  may be a castle tip. The tip  500   c  may be a wave tip. The tip  500   d  may be a saw tip. The tip  500   e  may be a scallop tip. The tip  500   f  may be a knife tip. One or more of the tips may assist in removal of material from the vasculature. 
     An exemplary actuation system that may be employed to allow for continuous rotation of the catheter may be a barrel cam. A barrel cam may be a device having a cam path extending around a circumference of a barrel and a cam follower pin configured to engage the cam path. The linear movement caused by actuation of the trigger may engage a cam follower pin that is spring loaded to engage the cam path on the face of the barrel. The cam path of the barrel may be a recessed path that translates the linear movement of the cam follower pin to rotational movement around the catheter axis. The cam path may be stepped to provide only one continuous path for the spring-loaded cam follower pin to follow and thus may provide continuous rotation in a single direction to the barrel. Connecting the catheter directly to the cannulated barrel may in turn rotate the catheter continuously. Other linear to rotational conversion devices may be employed to allow for continuous rotation of the catheter and/or intermittent rotation of the catheter as described previously. 
     Any of the features of the devices described herein may exchange or replace any of the other features in the devices without departing from the disclosure. For example, the trigger of device  100  may be used in device  10 ,  200 ,  300 ,  400 ,  700 , and  800  and vice-versa. Likewise, the actuation system of device  100  may be used in any of devices  10 ,  200 ,  300 ,  400 ,  700 , and  800  and vice-versa. 
       FIG.  12    shows an exemplary process  600  for using any of the devices described herein. In step  602 , the device (e.g., device  10 ) may be readied for use. Step  602  may further include any or all of sub-steps  602   a , including, but not limited to, unpacking the device, assembling the catheter to the handle, priming the device with saline, closing the valve (e.g., valve  36 ), and/or creating the vacuum (e.g., pulling and locking the plunger). After readying of the device, the user (e.g., a physician), at step  604 , may obtain access to the vasculature to be treated. The user may create a restriction in blood flow at step  606 . Alternatively, the restriction in blood flow at step  606  may be performed prior to gaining access in step  604 . The restriction in blood flow created at step  606  may include any or all of sub-steps  606   a , including, but not limited to, placing a pressure cuff, applying pressure to the vasculature, monitoring blood pressure, monitoring cuff pressure, adjusting pressure in the vasculature based on the blood pressure measured and/or based on the cuff pressure monitored. For example, if the blood pressure is not less than the cuff pressure, then the pressure in vasculature may be adjusted. 
     With continued reference to  FIG.  12   , the user may perform an interventional procedure at step  608 . As discussed previously, this step may be optional and the user may instead use the device  10  without an interventional device such as used in step  608 . 
     The user, at step  610 , may deliver the catheter (e.g., catheter  60 ) of the device over a guidewire and through a sheath and at step  612 , may remove the guidewire. Step  612  may be optional and the guidewire may remain during use of the device. With the device in the proper location, the user may begin operation of the device. This may include opening the valve to initiate the suction to remove material at step  614   a , actuating the trigger to initiate rotation of the catheter at step  614   b , and/or moving the device longitudinally to and fro (e.g., proximal and distal movement) at step  614   c . Any or all of steps  614   a ,  614   b , and  614   c  may be performed, in any order, sequentially, simultaneously, or may be omitted. 
     At step  616 , the chamber (by way of the view window) may be monitored for collection of materials. When the desired amount of material is removed, the user may remove the system from the sheath at step  618 . The procedure may be repeated as necessary at the same or different locations. When completed, the cuff may be removed. If, in step  616 , the chamber is completely filled, the chamber may be emptied and a suction re-established to continue removal of material as necessary. 
       FIGS.  13  and  14    show another exemplary device  700 . According to this embodiment, a helical screw pattern is utilized to transmit linear motion of the trigger  718  into rotational motion of a gear/driver  752 , as described in further detail below. One of the advantages of this embodiment, is that the liquid flow path or lumen  746  is separated from the actuation system  748  or rotational drive mechanism that includes a helix  755  and shuttles  750 ,  751  by a gear set  752 ,  754 . This reduces the complexity of the rotating components and ensures that the rotational components do not pass bodily fluids and are, therefore, not required to meet the same biocompatibility requirements as the liquid path. 
     The exemplary device  700  of  FIGS.  13  and  14    may be the same or similar as the device  10  and similar numerals are relied upon to describe like components. Components not described in  FIGS.  13  and  14    may be the same or similar as to like illustrated components in device  10 . The device  700  may be used in the aforementioned method. The device  700  may include a handle  714  and a trigger  718 . The trigger  718  may include a pivot  719 . The pivot  719  may be a pin or other fastener or device which allows for a pivoting action of the trigger  718 . The pivot  719  may be a low pivot point. The pivot  719  may be located within the handle  714 . 
     In this embodiment, the handle  714  includes the trigger  718  and a biasing member  720 , in the form of a spring, such as a coil spring, although other biasing devices are contemplated. The biasing member  720  may begin in a neutral state to be compressed by the trigger  718  during actuation of the device  700 . When force is released from the trigger  718 , the compressed biasing member  720  may extend back to the neutral state. 
     The rotating component of the liquid flow path or lumen  746  of this embodiment is the gear/driver  752 , which is separated from the valve  736  (e.g., a manual stop valve or non-rotating stopcock) and the plunger  724  (e.g., locking syringe) by a rotating seal  756 . This rotating seal  756  is configured to provide a leak-free flow path along the lumen  746 , while allowing free rotation between the ends of the device  700 . The housing  716  supports and locates the components of the actuation system  748  or rotational drive mechanism and bearings/bushings may be added to reduce friction and ease rotation. 
     When the trigger  718  is actuated, it moves a free shuttle  751 . The free shuttle  751  engages with and drives a drive shuttle  750 , which features an internal helical pattern matching that of the helix  755 . When the drive shuttle  750  passes over the helix  755 , it causes the helix  755  to rotate around a drive shaft  766 . This rotation spins the gear  754 , which drives the gear/driver  752 , to which a catheter is connected (see, e.g., catheter  60  of  FIGS.  2  and  5   ) via a coupling  758 . The biasing member  720  (e.g., compression spring) returns the shuttles  750 ,  751  and the trigger  718  to their starting positions at the front of the device  700  (i.e., the right side of the device  700  in  FIG.  14   ) after each trigger actuation. The teeth by which the drive shuttle  750  and the free shuttle  751  engage can be configured such that only rotation in one direction is allowed. According to one embodiment, it is advantageous to the function of the actuation system  748  or rotational drive mechanism that the catheter (e.g., catheter  60 ) rotate unidirectionally, so as the biasing member  720  (e.g., compression spring) returns the shuttles  750 ,  751  and the trigger  718  to their starting positions, the drive shuttle  750  will rotate freely around the helix  755  without engaging the free shuttle  751  or causing the helix  755  or gear/driver  752  to rotate. This motion may be repeated throughout the duration of the aspiration. 
     According to this embodiment, the aspiration process is simplified by the integration of a plunger  724  (e.g., locking syringe) and a valve  736  (e.g., stopcock). To create vacuum pressure, the valve  736  (e.g., stopcock) is set to a “closed” position, by depressing knob  740 , and plunger  724  (e.g., locking syringe) is drawn. Rotation of the plunger  724  (e.g., locking syringe) allows it to lock in place, resisting the closing force created by the vacuum. The user may then proceed with other aspects of the procedure. For example, to remove emboli, the user will begin rotation with one hand via the trigger  718  and subsequently open the valve  736  (e.g., stopcock) with the other hand, using the knob  740 , to release suction and begin aspiration of emboli. The aforementioned features of the embodiment of the device illustrated in  FIGS.  13  and  14    allow for separation of the mechanisms of suction and rotation, while allowing for simultaneous suction and rotation, with the ability to begin rotation prior to suction, in order to agitate/disperse emboli prior to aspiration. 
       FIGS.  15  and  16    show another exemplary device  800 . According to this embodiment, a bevel gear set  852 ,  854  is utilized, along with a constant force spring  855  and a one-way locking bearing  880  to transmit linear motion of the trigger  818  into rotational motion of a coupling  858  (e.g., luer adapter), which is generally attached to a catheter (see, e.g., catheter  60  of  FIGS.  2  and  5   ). One of the advantages of this embodiment, is that the liquid flow path or lumen  846  is separated from the actuation system  848  or rotational drive mechanism that includes the constant-force spring  855  and one-way locking bearing  880 . According to this embodiment, the complexity of the rotating components is reduced, while ensuring that the rotational components do not pass bodily fluids and are, therefore, not required to meet the same biocompatibility requirements as the liquid path. 
     The exemplary device  800  of  FIGS.  15  and  16    may be the same or similar as the device  10  and similar numerals are relied upon to describe like components. Components not described in  FIGS.  15  and  16    may be the same or similar as to like illustrated components in device  10 . The device  800  may be used in the aforementioned method. The device  800  may include a handle  814  and a trigger  818 . The trigger  818  may include a pivot  819 . The pivot  819  may be a pin or other fastener or device which allows for a pivoting action of the trigger  818 . The pivot  819  may be a low pivot point. The pivot  819  may be located within the handle  814 . 
     In this embodiment, the handle  814  includes the trigger  818  and a biasing member  820 , in the form of a pin, although other biasing devices are contemplated. The biasing member  820  (e.g., pin) may start at an initial position to be biased by the trigger  818  during actuation of the device  800 . When force is released from the trigger  818 , the biasing member  820  (e.g., pin) may return to its initial position. 
     The rotating component of the liquid flow path or lumen  846  of this embodiment is the coupling  858  (e.g., luer adapter). The coupling  858  is separated from the valve  836  (e.g., a manual stop valve or non-rotating stopcock) and the plunger  824  (e.g., locking syringe) by a rotating seal  856 . The rotating seal  856  is configured to provide a leak-free flow path along the lumen  846 , while allowing free rotation between the ends of the device  800 . A small bevel gear  852  is fixed axially to the outside of one end of the rotating seal  856 , which allows the gear  852  to drive rotation, while remaining separated from bodily fluids. The housing  816  supports/locates the components of the actuation system  848  or rotational drive mechanism and bearings/bushings may be added to reduce friction and ease rotation. 
     When the trigger  818  is actuated, it pulls/uncoils the constant-force spring  855 , via the biasing member  820  (e.g., pin). The constant-force spring  855  is coiled around a one-way locking bearing  880 . According to one embodiment, the one-way locking bearing  880  allows free rotation in one direction, but locks to prevent rotation in the other direction. The one-way bearing  880  is generally oriented such that it will lock in the direction of uncoiling of the constant-force spring  855 . This locking of the one-way bearing  880  turns the drive shaft  866  and large bevel gear  854 , which engages with and rotates the small bevel gear  852  to drive the coupling  858  (e.g., luer adapter) and any catheter (see, e.g., catheter  60  of  FIGS.  2  and  5   ) to which the coupling  858  may be connected. According to one embodiment, it is advantageous to the function of the actuation system  848  or rotational drive mechanism that the catheter (e.g., catheter  60 ), via coupling  858  (e.g., luer adapter), rotates unidirectionally, so as the trigger  818  is returned to its starting position by the coiling force of the constant-force spring  855 , the one-way locking bearing  880  will freely rotate about the drive shaft  866  and allow the constant-force spring  855  to coil without rotating the drive shaft  866  or any other rotating components. This motion may be repeated throughout the duration of the aspiration. 
     According to this embodiment, the aspiration process is simplified by the integration of a plunger  824  (e.g., locking syringe) and a valve  836  (e.g., stopcock). To create vacuum pressure, the valve  836  (e.g., stopcock) is set to a “closed” position, by depressing knob  840 , and plunger  824  (e.g., locking syringe) is drawn. Rotation of the plunger  824  (e.g., locking syringe) allows it to lock in place, resisting the closing force created by the vacuum. The user may then proceed with other aspects of the procedure. For example, to remove emboli, the user will begin rotation with one hand via the trigger  818  and subsequently open the valve  836  (e.g., stopcock) with the other hand, using the knob  840 , to release suction and begin aspiration of emboli. The aforementioned features of the embodiment of the device illustrated in  FIGS.  15  and  16    allow for separation of the mechanisms of suction and rotation, while allowing for simultaneous suction and rotation, with the ability to begin rotation prior to suction, in order to agitate/disperse emboli prior to aspiration. 
       FIGS.  17  and  18    show another exemplary device  900 . According to this embodiment, a helical screw pattern is utilized to transmit linear motion of the trigger  918  into rotational motion of a gear/driver  952 , as described in further detail below. One of the advantages of this embodiment, is that the liquid flow path or lumen  946  is separated from the actuation system  948 , also referred to as a rotational drive mechanism, that includes a gear set  952 ,  954  free shuttle  951 , drive shuttle  950 , slip ring  953 , helix  955 , and biasing member  920  by the gear set  952 ,  954 . This reduces the complexity of the rotating components and ensures that the rotational components do not pass bodily fluids and are therefore not required to meet the same biocompatibility requirements as the liquid path. 
     The exemplary device  900  of  FIGS.  17  and  18    may be the same or similar as the device  10  and similar numerals are relied upon to describe like components. Components not described in  FIGS.  17  and  18    may be the same or similar as to like illustrated components in device  10 . The device  900  may be used in the aforementioned method. The device  900  may include a handle  914  and a trigger  918 . The trigger  918  may include a pivot  919 . The pivot  919  may be a pin or other fastener or device which allows for a pivoting action of the trigger  918 . The pivot  919  may be a low pivot point. The pivot  919  may be located within the handle  914 . 
     In this embodiment, the handle  914  includes the trigger  918  and a biasing member  920 , in the form of a compression spring, such as a coil spring, although other biasing devices are contemplated. The biasing member  920  may begin in a neutral state to be compressed by the trigger  918  during actuation of the device  900 . When force is released from the trigger  918 , the compressed biasing member  920  may extend back to the neutral state. 
     The rotating component of the liquid flow path or lumen  946  of this embodiment is the gear/driver  952 , which is separated from the valve  936  (e.g., a manual stop valve or non-rotating stopcock) and the plunger  924  (e.g., locking syringe) by a rotating seal  956 . This rotating seal  956  is configured to provide a leak-free flow path along the lumen  946 , while allowing free rotation between the ends of the device  900 . The housing  916  supports and locates the components of the actuation system  948  or rotational drive mechanism and bearings/bushings may be added to reduce friction and ease rotation. The plunger  924 , also referred to as a locking syringe  924 , is non-rotating. The seal  956  allows the proximal end of the valve  936 , containing the valve, to remain stationary. 
     When the trigger  918  is actuated, it moves a free shuttle  951 . The free shuttle  951  engages with and drives a drive shuttle  950 , which features an internal helical pattern matching that of the helix  955 . When the drive shuttle  950  passes over the helix  955 , it causes the helix  955  to rotate. This rotation spins the gear  954 , which may be a helix gear  954 , which drives the gear/driver  952 , to which a catheter is connected (see, e.g., catheter  60  of  FIGS.  2  and  5   ) via a coupling  958 . The biasing member  920  (e.g., compression spring) returns the shuttles  950 ,  951  and the trigger  918  to their starting positions at the front of the device  900  (i.e., the right side of the device  900  in  FIG.  17   ) after each trigger actuation. The slip ring  953  may reduce friction between the biasing member  920  and the drive shuttle  950 . The teeth by which the drive shuttle  950  and the free shuttle  951  engage can be configured such that only rotation in one direction is allowed. According to one embodiment, it is advantageous to the function of the actuation system  948  or rotational drive mechanism that the catheter (e.g., catheter  60 ) rotate unidirectionally, so as the biasing member  920  (e.g., compression spring) returns the shuttles  950 ,  951  and the trigger  918  to their starting positions, the drive shuttle  950  will rotate freely around the helix  955  without engaging the free shuttle  951  or causing the helix  955  or gear/driver  952  to rotate. This motion may be repeated throughout the duration of the aspiration. 
     According to this embodiment, the aspiration process is simplified by the integration of a plunger  924  (e.g., locking syringe) and a valve  936  (e.g., stopcock). To create vacuum pressure, the valve  936  (e.g., stopcock) is set to a “closed” position, by depressing knob  940 , and plunger  924  (e.g., locking syringe) is drawn. Rotation of the plunger  924  (e.g., locking syringe) allows it to lock in place, resisting the closing force created by the vacuum. The user may then proceed with other aspects of the procedure. For example, to remove emboli, the user will begin rotation with one hand via the trigger  918  and subsequently open the valve  936  (e.g., stopcock) with the other hand, using the knob  940 , to release suction and begin aspiration of emboli. The aforementioned features of the embodiment of the device illustrated in  FIGS.  17  and  18    allow for separation of the mechanisms of suction and rotation, while allowing for simultaneous suction and rotation, with the ability to begin rotation prior to suction, in order to agitate/disperse emboli prior to aspiration. Accordingly, as shown and described with respect to  FIGS.  17  and  18   , the device  900  includes a drive path configured to translate linear movement to rotational movement, a suction path configured to create a controlled suction to remove the material from the vasculature, and a catheter coupled to the drive path and the suction path. The suction path is parallel to and offset from the drive path. 
     The device of the present disclosure may allow for the removal of material from a remote location in the vasculature. The combination of the suction and rotation of the device may enhance the ability to remove material resulting in clearer vasculatures as compared to prior art devices. In an example of such a remote location, the device may be used in the artery of a lower extremity (e.g., a leg) in combination with an external cuff. The external cuff may create a dam preventing material from flowing throughout the body. With the external cuff in place, the device of the present disclosure may be utilized to fully clear any material from the vasculature at the location of the distal tip of the catheter of the device and/or at the location of an interventional procedure. 
     The device of the present disclosure may be used in conjunction with a blood pressure cuff placed distal to the vasculature being treated to stop the blood flow from going distal in the vasculature. A clot, thrombus, and distal emboli that can flow distally can cause additional problems if left in the vasculature. By placing the cuff distally, such additional problems may be avoided. The device may remove the material (e.g., clot, thrombus, emboli, or debris) therefrom. 
     As described herein, the device may remove material from within a vasculature. The material may be, but is not limited to, a clot, thrombus, emboli, obstruction, particles, fluid, plaque, debris, debris from an interventional procedure, or other material located in a vasculature. Although described in conjunction with an interventional procedure, the device itself may be used to perform the interventional procedure. That is, in one example, an interventional procedure may dislodge or destroy an obstruction in the vasculature and the device of the present disclosure may be employed to remove the debris caused by the interventional procedure. In another example, the device itself may dislodge or destroy the obstruction in the vasculature and may be subsequently, or simultaneously, remove debris caused by the dislodging or destruction. 
     The device of the present disclosure may comprise three core elements: a catheter, a proximal rotating element, and a negative pressure element. The catheter may be a braided, over-the-wire catheter with about a 4 French inner diameter and a 5 French outer diameter. The catheter may include a PTFE lined core and a tapered tip. The catheter may be 6 French guiding sheath compatible. The catheter may be sterile. The proximal rotating element may be secured to the catheter via a catheter hub. The proximal rotating element may be a mechanical tool which imparts rotational energy to the catheter. The proximal rotating element may include a central lumen to connect to the catheter distally and the negative pressure element proximally. The proximal rotating element may be sterile. The negative pressure element may be a simple, large capacity locking syringe with a two-way stop-cock or one of the devices described herein. The negative pressure element may be securely attached to the proximal rotating element. The negative pressure element may be sterile. 
     In an example method, upon removing from the sterile pouch and assembling the catheter and proximal rotating element, the device may be primed with heparinized saline. The device may be introduced over a compatible guidewire (for example, 0.014″, 0.018″ or 0.035″) into the peripheral vasculature through a 6 F sheath. The catheter may be delivered over the guidewire to the distal portion of the treated area. The delivery guidewire may be removed. The negative pressure element may be prepared by attaching the stopcock in the closed position. The plunger may be pulled back fully and locked to generate the full capacity of negative pressure. The negative pressure element may be attached to a proximal end of the proximal rotating element. The proximal rotating element may be engaged to impart rotational energy to the catheter and the stopcock may be opened to impart suction at the distal tip of the catheter to loosen and remove material, such as, for example, a thrombus and/or distal emboli. Upon reaching full capacity of the negative pressure element, the syringe (e.g., the device of the present disclosure) may be removed from the treatment zone and the contents may be emptied into a 30-50 μm filter. The process may be repeated prior as necessary prior to removing the system from the guiding sheath. 
     The cuff may be put on the patient any time prior to the intervention (e.g., work on the diseased artery is started). The cuff may be put on the patient when the patient is first prepared for the procedure. The cuff may be inflated prior to the intervention to stop blood flow prior to and during the intervention to keep thrombus, clot, or debris from flowing past the diseased area/cuff and removed by the device of the present disclosure. The cuff may then be deflated after the procedure and/or after an angiogram that confirms the positive results of the intervention and removal of the material via the device. If more interventional work is needed the cuff may be re-inflated to repeat the procedure as needed to fully remove the material from the vasculature. 
     Use of language such as “at least one of X, Y, and Z,” “at least one of X, Y, or Z,” “at least one or more of X, Y, and Z,” “at least one or more of X, Y, or Z,” “at least one or more of X, Y, and/or Z,” or “at least one of X, Y, and/or Z,” are intended to be inclusive of both a single item (just X, or just Y, or just Z) and multiple items (i.e., {X and Y}, {X and Z}, {Y and Z}, or {X, Y, and Z}). “At least one of” is not intended to convey a requirement that each possible item must be present. 
     Although the foregoing description is directed to the preferred embodiments of the invention, it is noted that other variations and modifications will be apparent to those skilled in the art, and may be made without departing from the spirit or scope of the invention. Moreover, features described in connection with one embodiment of the invention may be used in conjunction with other embodiments, even if not explicitly stated above.