Catheter systems, devices, and methods

Abstract

Disclosed are embodiments of an aspiration system that include a dilator and an aspiration catheter. The dilator has a shaft with a lumen extending therethrough and a connection feature at a distal end thereof. The aspiration catheter includes a shaft having an aspiration lumen extending therethrough. The aspiration lumen is configured to have the dilator disposed therein and selectively connected to a distal end of the aspiration catheter. Also disclosed is a hemostasis valve (476) including a rotatable shaft (480) for twisting the valve conduit open and closed.

Description

CATHETER SYSTEMS, DEVICES, AND METHODS Inventor: Randolf von Oepen & Michael L. GreenBACKGROUND OF THE INVENTIONTechnical Field

[0001] The present disclosure pertains generally to medical devices and methods of their use. More particularly, the present disclosure pertains to catheter systems, devices, and methods of use thereof.Description of the Related Art

[0002] Several devices and systems already exist to aid in the removal of thrombotic material. These include simple aspiration tube type devices using vacuum syringes to extract thrombus into the syringe, simple flush-and-aspirate devices, more complex devices with rotating components that pull in, macerate, and transport thrombotic material away from a distal tip using a mechanical auger, and systems that use very high pressure fluid sprays to macerate the thrombus and create a venturi effect to flush the macerated material away.

[0003] All of the devices described above have limitations as a result of individual design characteristics. As such, what is needed are systems, methods, and devices, that allow for the placement of larger diameter devices within a body lumen.SUMMARY

[0004] This Summary' is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary' is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

[0005] Implementations of the present disclosure solve one or more problems in the art with thrombectomy systems and devices, and methods for use thereof. In one implementation, an aspiration system includes a dilator and an aspiration catheter. The dilator has a shaft with a lumen extending therethrough and a connection feature at a distal end thereof. The aspiration catheter includes a shaft having an aspiration lumen extending therethrough. The aspiration lumen is configured to have the dilator disposed therein and selectively connected to a distal end of the aspiration catheter.

[0006] In another embodiment, a catheter system includes a catheter and a handle. The catheter has a proximal end. a distal end, and a lumen extending therethrough between the proximal and distal ends. The handle is attached to the proximal end of the catheter andincludes a hemostasis valve. The hemostasis valve includes a shaft having a lumen extending therethrough; a mount having a lumen therethrough; and a valve conduit having a first end attached to the shaft, a second end attached to the lumen, and a lumen extending therethrough. The shaft is rotatable relative to the mount between a first position and a second position, such that the lumen in the valve conduit is open when the shaft is in the first position and closed when the shaft is in the second position.

[0007] In yet another embodiment, a valve includes: a frame; a shaft having a lumen extending therethrough, the shaft being rotatably associated with the frame; a mount having a lumen therethrough, the mount being associated with the frame in a fixed position relative to the frame; and a valve conduit having a first end attached to the shaft, a second end attached to the lumen, and a lumen extending therethrough. The shaft is rotatable relative to the frame and the mount between a first position and a second position such that the lumen in the valve conduit is open when the shaft is in the first position and closed when the shaft is in the second position.

[0008] Additional features and advantages of exemplary implementations of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of such exemplary implementations. The features and advantages of such implementations may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features will become more fully apparent from the following description and appended claims or may be learned by the practice of such exemplary' implementations as set forth hereinafter.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Various objects, features, characteristics, and advantages of the invention will become apparent and more readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings and the appended claims, all of which form a part of this specification. In the Drawings, like reference numerals may be utilized to designate corresponding or similar parts in the various Figures, and the various elements depicted are not necessarily drawn to scale, wherein:

[0010] Figure 1 illustrates a catheter system according to an implementation of the present disclosure.

[0011] Figure 2 illustrates a handle of a catheter of the system of Figure 1 according to an implementation of the present disclosure.

[0012] Figures 3A and 3B illustrate a hemostasis valve of a catheter of the system of Figure 1 according to an implementation of the present disclosure.

[0013] Figure 4 illustrates a hemostasis valve of a catheter of the system of Figure 1 according to an implementation of the present disclosure.

[0014] Figure 5 illustrates a hemostasis valve of a catheter of the system of Figure 1 according to an implementation of the present disclosure.

[0015] Figures 6A-6D illustrate hemostasis valves of a catheter of the system of Figure 1 according to implementations of the present disclosure.

[0016] Figures 7A and 7B illustrate hemostasis valves of a catheter of the system of Figure 1 according to implementations of the present disclosure.

[0017] Figures 8 A and 8B illustrate a hemostasis valve of a catheter of the system of Figure 1 according to an implementation of the present disclosure.

[0018] Figure 9 illustrates a powered vacuum source of the system of Figure 1 according to an implementation of the present disclosure.

[0019] Figure 10 illustrates a cross-sectional view of a catheter of the system of Figure 1 according to an implementation of the present disclosure.

[0020] Figures 11A-11C illustrate example connection features for connecting a dilator and a catheter of the system of Figure 1 according to an implementation of the present disclosure.

[0021] Figure 12 illustrates a cross-sectional view of the distal end of the catheter of the system of Figure 1 according to an implementation of the present disclosure.

[0022] Figure 13 illustrates another cross-sectional view of the distal end of the catheter of Figure 5 with a balloon thereof inflated according to an implementation of the present disclosure.

[0023] Figure 14 illustrates a distal end of the system of Figure 1 within a body lumen and adjacent to a thrombus according to an implementation of the present disclosure.

[0024] Figure 15 illustrates a distal end of the catheter of the system of Figure 1 within a body lumen and with the dilator removed according to an implementation of the present disclosure.

[0025] Figure 16 illustrates the catheter within the body lumen with the balloon deployed and aspirating the thrombus according to an implementation of the present disclosure.

[0026] Figure 17 illustrates a sheath being introduced over the catheter to facilitate removal of catheter from the body lumen according to an implementation of the present disclosure.

[0027] Figure 18 illustrates a handle of a catheter of the system of Figure 1 according to an implementation of the present disclosure.

[0028] Figure 19 through Figure 22B illustrate sectional views of the handle of Figure 18;

[0029] Figures 23A and 23B illustrate a hemostasis valve input according to an implementation of the present disclosure.

[0030] Figure 24A through 25B illustrate a hemostasis valve according to an implementation of the present disclosure.

[0031] Figures 26A and 26B illustrate perspective views of a handle of a catheter of the system of Figure 1 according to an implementation of the present disclosure.

[0032] Figures 26C and 26D illustrate internal aspects of the handle of Figures 26A and 26B.

[0033] Figure 27 illustrates a perspective view of a handle of a catheter of the system of Figure 1 according to an implementation of the present disclosure.

[0034] Figure 28 illustrates a perspective view of a handle of a catheter of the system of Figure 1 according to an implementation of the present disclosure.

[0035] Figures 29A through 29D illustrate various view of a handle of a catheter of the system of Figure 1 according to an implementation of the present disclosure.DETAILED DESCRIPTION

[0036] One or more specific embodiments of the present disclosure will be described below. In an effort to provide a concise description of these embodiments, some features of an actual embodiment may be described in the specification. It should be appreciated that in the development of any such actual embodiment, as in any engineering or design project, numerous embodiment-specific decisions will be made to achieve the developers’ specific goals, such as compliance with system-related and business-related constraints, which may vary from one embodiment to another. It should further be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary' skill having the benefit of this disclosure.

[0037] While the present disclosure will describe particular implementations for aspiration systems, devices, and methods, it should be understood that the devices,systems, and methods described herein may be applicable to other uses. Additionally, any element or elements described in relation to any embodiment depicted and / or described herein may be combinable with any element or elements described in relation to any other embodiment depicted and / or described herein.

[0038] A system 100 for aspirating thrombus is illustrated in the Figures. As broadly shown in Figure 1, the system 100 includes a dilator 102, an aspiration catheter 104, and one or more vacuum sources 106. The dilator 102 may be used to facilitate positioning of the aspiration catheter 104 at a desired location within a body lumen. Once the aspiration catheter 104 is positioned as desired, the dilator 102 may be removed therefrom. The one or more vacuum sources 106 may thereafter be used to aspirate a thrombus out of the body lumen through the aspiration catheter 104.

[0039] As shown in Figure 1, the dilator 102 includes a shaft 108 and a hemostasis valve 110. The shaft 108 includes a lumen extending therethrough. The lumen opens at a distal end of the shaft 108. The hemostasis valve 110 may be disposed at a proximal end of the shaft 108 and may be configured to control or prevent the flow of air into the lumen and blood out of the lumen. In some embodiments, the hemostasis valve 110 is selectively connectable to the proximal end of the shaft 108 (e.g., via a luer lock). In other embodiments, the hemostasis valve 110 may be more permanently connected to the shaft 108.

[0040] The dilator 102 may be introduced into and / or advanced through a body lumen over a guidewire 1 12. For instance, the guidewire 1 12 may be inserted into the body lumen and the shaft 108 may be advanced over the guidewire 112 (e.g., with the guidewire 112 extending through the lumen of the shaft 108.

[0041] In some embodiments, including that of Figure 1, the dilator 102 includes a connection feature 114. The connection feature 114 may be disposed at or adjacent to a distal end of the shaft 108. The connection feature 114 may be configured to selectively to a distal end of the aspiration catheter 104. As discussed in greater detail below, the connection between the dilator 102 and the aspiration catheter 104 may facilitate the positioning of the aspiration catheter 104 within the body lumen. In some embodiments, the connection feature 114 is configured for selective disconnection from the aspiration catheter 104. In such embodiments, once the aspiration catheter 104 is positioned within a body lumen as desired, the connection feature 114 can be selectively disconnected from the aspiration catheter 104 and the dilator 102 can be withdrawn from the aspiration catheter 104 while leaving the aspiration catheter 104 in place within the body lumen.

[0042] As shown in Figure 1, the aspiration catheter 104 includes a handle 116 and a shaft 118. The handle is disposed at or adjacent to a proximal end of the shaft 118. The shaft 1 18 includes one or more lumens extending therethrough, which will be discussed in greater detail below. At least one of the lumens is an aspiration lumen 120 that extends between proximal and distal ends of the aspiration catheter 104. The aspiration lumen 120 opens to the distal end of the aspiration catheter 104.

[0043] The handle 116 includes a hemostasis valve 122 in fluid communication with the aspiration lumen 120. The hemostasis valve 122 is configured to limit or prevent the flow of air into the aspiration lumen 120 and control the flow of blood and thrombotic material out of the aspiration lumen 120.

[0044] The handle 116 may also include other controls or features. In some embodiments, for instance, the handle 116 may include one or more steering controls 124. The one or more steering controls 124 may be configured to steer the distal end of the shaft 108 of the aspiration catheter 104.

[0045] While the handle 116 is described as including both the hemostasis valve 122 and the one or more steering controls 124, it will be appreciated that this is only an example, the hemostasis valve 122 and the one or more steering controls 124 may be incorporated into the same component (e.g., handle) or they may be separate from one another.

[0046] The aspiration catheter 104 may be configured for aspirating thrombus from body lumens, including peripheral vessels, coronary, cerebral, pulmonary or other arteries, or veins. The aspiration catheter 104 may be used in interventional procedures, but may also be used in surgical procedures. As noted, the aspiration catheter 104 includes the shaft 118 configured for placement within a body lumen of a subject, and has the aspiration lumen 120 extending from an open end at the distal end of the aspiration catheter 104 to the proximal end of the aspiration catheter 104.

[0047] The shaft 118 of the aspiration catheter 104 may have a length of about 40 cm, about 50 cm, about 60 cm, about 70 cm, about 80 cm, about 90 cm, about 100 cm, about 110 cm, about 120 cm, about 130 cm. about 140 cm, or about 150 cm. However, the shaft 118 may have a length that is longer or shorter than any of the noted lengths. Similarly, the shaft 118 may have an outer dimension of 8F, 10F, 12F, 14F, 16F, 18F, 20F, 22F, 24F, 26F, 28F, or any outer dimension larger or smaller than any of the noted dimensions.

[0048] In some embodiments, the shaft 118 of the aspiration catheter 104 may include multiple segments that have different properties. For instance, in the embodiment of Figure1, the shaft 118 includes first, second, and third segments 126, 128, 130, although other embodiments may include two segments or more than three segments. The different segments 126, 128, 130 may have different levels of stiffness or flexibility. For instance, the first segment 126 may be relatively stiff or less flexible than the segments 128, 130. Similarly, the second segment 128, while less stiff and more flexible than the first segment 126, may be relatively stiff or less flexible than the third segment 130. In some embodiments, the third segment 130 may be soft and highly flexible. For instance, the third segment 130 may be able to bend to a radius of less than or equal to about 20 mm. Nevertheless, the third segment 130 may be formed so as not to kink or collapse when bent to such a radius. In some embodiments, the first segment 126 has a shore hardness of about 72D. the second segment 128 has a shore hardness of about 55D. and the third segment 130 has a shore hardness of about 25D. The different stiffnesses may be desired for pushability, torqueability, navigation through tortuous body lumens, and the like.

[0049] In another embodiment, the shaft 118 may include fewer or more segments that three. For instance, in one embodiment, the shaft 118 may have four segments with differing levels of stiffness or flexibility. In such an embodiment, the distal most segment may have a shore hardness of about 40A, the second most distal segment may have a shore hardness of about 73A, the third most distal segment may have a shore hardness of about 25D or 35D, and the proximal most segment may have a shore hardness of about 55D. As noted, it will be appreciated that the number of segments and the shore hardness for each segment may vary from one embodiment to another.

[0050] In some embodiments, the first segment 126 may be formed of a hypotube. The hypotube may be formed of metals, alloys, and combinations or modifications thereof. The second segment 128 may similarly be formed of a hypotube. Alternatively, the second segment 128 may be formed of a variety of polymers and copolymers, plastics, PEBAX, HYTREL, rubber, Nylon, polyolefin, fluorinated polymers like FEP or PTFE, polyurethan, polyamides, and combinations or modifications thereof. The third segment 130 may likewise be formed from of a variety of polymers and copolymers, plastics, PEBAX. HYTREL. rubber. Nylon, polyolefin, fluorinated polymers like FEP or PTFE. polyurethan, polyamides, and combinations or modifications thereof.

[0051] The distal end of the shaft 118 may include an inflatable structure 132. As described in greater detail below, the inflatable structure 132 may be selectively inflated to temporarily secure the distal end of the shaft 118 in place within a body lumen. The inflated inflatable structure 132 may also create a seal with the interior or the body lumensuch that aspiration pressure exerted through the aspiration lumen 120 is focused on a thrombus adjacent to the distal end of the shaft 118. The inflated inflatable structure 132 may also center or otherwise space the open distal end of the shaft 118 away from the wall of the body lumen to prevent the open end of the shaft 118 from suctioning onto the body lumen wall and potentially damaging the body lumen wall. Still further, the inflated inflatable structure 132 may be configured to funnel thrombotic material into the aspiration lumen 120.

[0052] The distal end of the shaft 1 18 may also include one or more radiopaque (RO) markers 133 for identifying the location of aspiration. The radiopaque marker 133 may be a ring that encircles all or a portion of the circumference of shaft 118. In some embodiments, the RO marker 133 may include stripes on or sections of a ring. The RO marker 133 may be disposed between various layers of the shaft 118. The RO marker 133 can be formed of any suitable radiopaque material, such as tantalum, tungsten, platinum / iridium, gold, silver, radiopaque ink, and combinations or modifications thereof.

[0053] The one or more vacuum sources 106 may be in fluid communication with the aspiration lumen 120 and, optionally, the hemostasis valve 122. The one or more vacuum sources 106 may include a manual vacuum source 134. The manual vacuum source 134 may include a syringe having a plunger and a barrel. The manual vacuum source 134 may be attached to the handle 116 or the shaft 118 via a vacuum line 136. In some embodiments, the vacuum line 136 is connected to the handle 116 or the shaft 1 18 via a side arm. The plunger may be a locking variety of plunger that is configured to be locked in the retracted (vacuum) position as desired.

[0054] In addition or as an alternative to the manual vacuum source 134, the one or more vacuum sources 106 may include a powered vacuum source 138. The powered vacuum source 138 may be attached to the aspiration lumen 120 and, optionally, the hemostasis valve 122 via a vacuum line 142. The powered vacuum source 138 include a pump system.

[0055] Attention is now directed to Figure 2, which illustrates an example embodiment of the handle 116. As shown, the handle 116 includes a housing 144. a steering input 146. a vacuum input 148, an inflation input 150, a vacuum port 152, a flush port 154, and a hemostasis valve input 156. Other embodiments of the handle 116 may include less than or more than the noted features.

[0056] The steering input 146 may be connected to the distal end of the shaft 118 of the aspiration catheter 104 (e.g., via one or more steering elements) to enable steering ofthe distal end of the shaft 118. The steering input 146 may be moved in one or more directions to retract the one or more wires that are connected to the distal end of the shaft 118. Alternatively, the steering input 146 may include one or more electrical or electromechanical switches or buttons activate the steering capabilities. The retraction of the one or more wires may cause the distal end of the shaft 118 to bend in a desire direction, thereby enabling the distal end of the shaft 118 to be steered in a desired direction. In some embodiments, the steering input 146 also includes a lock input 158. The lock input may lock the steering input 146 in a desired position so as to hold the distal end of the shaft 118 in a desired orientation (e.g., such as curved in a desired direction).

[0057] The vacuum input 148 may be a lever, switch, button, or other user interface that can activate, deactivate, or adjust the level of vacuum pressure applied to the aspiration lumen 120. The vacuum input 148 may communicate with the manual or powered vacuum source 134, 138 to control the vacuum pressure generated by the manual or powered vacuum source 134, 138. In other embodiments, the vacuum input 148 may be associated with the manual or powered vacuum source 134, 138 and may not be part of the handle 116.

[0058] The inflation input 150 may be a lever, switch, button, or other user interface that can activate, deactivate, or adjust an inflation pressure provided to the inflatable structure 132. For instance, the inflation input 150 may communicate with a pump or other structure configured to generate a positive pressure. Activation of the inflation input 150 may cause the pump or other structure to generate a positive pressure and communicate that pressure through an inflation lumen in the aspiration catheter 104 (via an inflation portion 151 on the handle) to inflate the inflatable structure 132. Similarly, the inflation input 150 may be configured to cause the pump or other structure to vary the inflation pressure to a desire level. Still further, the inflation input may be configured to cause the pump or other structure to create and communicate a negative pressure to the inflatable structure 132 to deflate the inflatable structure 132.

[0059] The vacuum port 152 may be in fluid communication with the aspiration lumen 120. Additionally, the vacuum port 152 may be configured for permanent or selective connection to the vacuum line(s) 136, 142. Thus, when the manual or power vacuum source 134, 138 is activated, the negative pressure generated thereby is communicated to the aspiration lumen 120 via the vacuum port 152.

[0060] The flush port 154 may be in fluid communication with the aspiration lumen 120. The flush port 154 may be selectively connected to a fluid source, such as a salinebag or pump. The fluid source may be pressurized to cause the fluid to flow through the flush port 154 and into the aspiration lumen 120 to clear / deair the aspiration lumen 120.

[0061] The valve input 156 may be configured to control the hemostasis valve 122. For instance, the valve input 156 may be configured to allow for selective opening and closing of the hemostasis valve 122. The valve input 156 comprises one or more buttons. In the illustrated embodiment, the valve input 156 includes two buttons 160, 162 on opposite sides of the handle 1 16. Pressing one or both of the buttons 160, 162 may cause the hemostasis valve 122 to open. In contrast, removing external pressure from the buttons 160, 1 2 may cause the hemostasis valve 122 to close.

[0062] Figures 3A and 3B illustrate an example embodiment of a hemostasis valve 122. As illustrated, the hemostasis valve 122 includes two cam frames 164, 166. In the illustrated embodiment, each of the cam frames 164, 166 is generally circular with an aperture extending therethrough. The cam frames 164, 166 are spaced apart from one another and a flexible tube 168 is connected between the cam frames 164, 166. The flexible tube 168 includes a lumen therethrough and which opens to or extends through the apertures in the cam frames 164, 166. The flexible tube 168 may be formed from a variety of polymers and copolymers, plastics, PEBAX, HYTREL, rubber, Nylon, polyolefin, fluorinated polymers like FEP or PTFE, polyurethan, polyamides, silicone, and combinations or modifications thereof. In some embodiments, the flexible tube can be a silicon valve which is pre-shaped, such as in an hourglass shape. The wall thickness thereof can be variable to allow for easier deformation (sealing) in certain areas For instance, the wall thickness at the waist of the hourglass can be thinner for easier deformation.

[0063] The cam frames 164, 166 are connected to buttons 160, 162. The connection between the cam frames 164, 166 and the buttons 160, 162 may be a direct connection or, as shown in Figures 3 A, 3B, via one or more links 170. The connection points on the cam frames 164, 166 may be rotationally offset from one another as shown in Figures 3A, 3B.

[0064] The buttons 160, 162 may be biased outwardly away from the cam frames 164, 166. The biasing may be achieved with springs mounted between the buttons 160, 162 and the housing 144. When the buttons 160. 162 are moved outwardly as shown in Figures 3A. 3B, the cam frames 164, 166 may be rotated in opposite directions such that the flexible tube 168 is twisted. Twisting the flexible tube 168 may cause the lumen therein to be closed partially or entirely. In contrast, pressing the buttons 160, 162 inwards towards the cam frames 164, 166 may overcome the outward biasing force and cause the cam frames 164, 166 to rotate in opposite directions. When the cam frames 164, 166 rotate in oppositedirection upon pressing the buttons 160, 162, the flexible tube 168 may untwist, thereby partially or entirely opening the lumen therein.

[0065] Figure 4 illustrates another example embodiment of the hemostasis valve 122. Similar to the embodiment of Figures 3A, 3B, the embodiment of Figure 4 includes opposing buttons 172, 174, spaced apart valve frames 176, 178, and a flexible tube 180. The valve frames 176. 178 include apertures extending therethrough and the flexible tube 180 includes a lumen that opens into or extends through the apertures in the valve frames 176, 178. The flexible tube 180 may be similar or identical to the flexible tube 168.

[0066] The buttons 172, 174 and the valve frames 176, 178 are linked together via a rack and pinion configuration. More specifically, each of the valve frames 176, 178 include outwardly facing gear teeth disposed around at least a portion of the circumference thereof, similar to a pinion gear. Each of the buttons 172, 174 includes first and second racks 182, 184 with gear teeth that mate with the gear teeth on the valve frames 176, 178. In the illustrated embodiment, the first rack 182 of the button 172 and the second rack 184 of the button 174 engage the valve frame 176. Similarly, the first rack 182 of the button 174 and the second rack 184 of the button 172 engage the valve frame 178. Pressing the buttons 172, 174 inwardly (e.g., towards one another and towards the valve frames 176, 178 causes the first and second racks 182, 184 of each button 172, 174 to rotate the valve frames 176, 178 in opposite directions. Such rotation of the valve frames 176, 178 may cause the flexible tube 180 to rotate to an open position, where the lumen is open and unobstructed.

[0067] In the illustrated embodiment, the buttons 172, 174 are biased towards a nondepressed position. The biasing of the buttons 172, 174 can be accomplished with abiasing member 186, such as a spring or a compressible elastic element such as a silicon block. The biasing member 186 may be disposed between a surface on the housing 144 and one of the buttons 172, 174 so as to urge the buttons 172, 174 away from one another and away from the valve frames 176, 178. When the buttons 172, 174 are moved away from one another, the rack and pinion configuration causes the valve frames 176, 178 to rotate in opposite directions from one another and opposite to the directions when the buttons 172, 174 are pressed. Such rotation causes the opposing ends of the flexible tube 180 to be twisted in opposite directions from one another, which will twist the lumen therethrough closed.

[0068] While each of the buttons in Figures 3A-4 are connected to two cam or valve frames, this is merely exemplary. In other embodiments, each button may only be connected to a single cam or valve frame. In such cases, pressing one button may causeone of the cam or valve frames to rotate while the other cam or valve frame remains stationary.

[0069] Attention is now direction to Figure 5, which illustrates a portion of another embodiment of the hemostasis valve 122. In the illustrated embodiment, the hemostasis valve 122 includes a flexible tube 188 surrounded by a plurality of valve plates 190. In the illustrated embodiment, each of the valve plates 190 includes a notch 192 that receives the flexible tube 188 therein. Connected to each of the valve plates 190 is a pivot plate 194. One or more of the pivot plates 194 are connected to the one or more buttons (e.g., buttons 160, 162) on the handle 116.

[0070] As with the previous embodiments, the valve plates 190 may be biased to a closed position. In the closed position, the valve plates 190 may be moved towards the flexible tube 188, which may cause the flexible tube to compress and / or twist to close the lumen therethrough. In contrast, pressing the one or more buttons may cause the valve plates 190 to move away from the flexible tube 188, which may cause the flexible tube to expand, thereby opening the lumen therethrough. For instance, pressing the one or more buttons may cause the pivot plates 194 to pivot or rotate. The pivoting or rotating movement of the pivot plates 194 may cause the valve plates 190 to move away from one another and the flexible tube 188, thereby allowing the lumen in the flexible tube 188 to open.

[0071] Attention is now directed to Figures 6A-6D, which illustrate additional example embodiments of the hemostasis valve 122. In each of the embodiments of Figures 6A-6D, the valve includes opposing first and second jaws 196, 198. Each of the jaws 196, 198 includes a notch 200 disposed around a flexible tube 202. The jaws 196, 198 may be biased towards one another with one or more biasing members 204 (e.g., springs). When the jaws 196, 198 are moved closer together, the jaws 196, 198 may compress the flexible tube 202, thereby closing a lumen therein.

[0072] In each embodiment, the jaws 196, 198 may be pivoted away from one another to allow for the flexible tube 202 to expand to open the lumen therein. For instance, in Figure 6A. first ends of the jaws 196, 198 may be pivotally connected to the handle at one or more pivots 206. A button 208 may be disposed adjacent second ends of the jaws 196, 198. The button 208 may engage one or more cam surfaces 210 on the second ends of the jaws 196, 198. As the button 208 is pressed, the button 208 moves along the cam surfaces 210, which caused the jaws 196, 198 to spread apart. As the jaws 196, 198 spread apart, the flexible tube 202 is able to expand and the lumen therein can open.

[0073] The embodiment of Figure 6B is similar to that of Figure 6A. The primary difference between the embodiments of Figures 6A and 6B is that the jaws 196. 198 in Figure 6B are pivotally mounted at pivots 206 at their seconds ends rather than their first ends as in Figure 6A. Thus, in Figure 6B, the pivots 206 and the button 208 are disposed on the same side of the flexible tube 202, rather than on opposite sides as in Figure 6A. Additionally, each of the jaws 196, 198 in mounted on its own pivot 206.

[0074] The embodiment of Figure 6C can be a narrower configuration. In the embodiment of Figure 6B, the jaws 196, 198, pivots 206, and button 208 were arranged in a common plane. As a result, the pivots 206 had to be spread apart far enough to allow7for the button 208 to pass therebetween. In the embodiment of Figure 6C, each of the jaw s 196, 198 includes a wing 212 that extends laterally to a side of the button 208. The wings 212 are connected to the pivots 206. As a result, the pivots 206 can be positioned to a single side of the button 208 and in a separate plane therefrom and the jaws 196, 198 do not have to extend tow ards opposing sides of the button 208 as in Figure 6B.

[0075] Figure 6D illustrates an embodiment with tw o additional jaws 214, 216 that are configured to provide additional compression to the flexible tube 202. The jaws 214, 216 may be associated with the jaws 196, 198. For instance, the jaws 196, 198 may include notches formed therein for receiving the jaws 214, 216 therein. The notches may include cam surfaces 218. As the jaws 196, 198 move closer together, the cam surfaces 218 may cause the jaws 214, 216 to likewise move closer together. The jaws 214. 216 may include notches, similar to notches 200, for receiving the flexible tube 202 therein. As the jaws 196, 198, 214, 216 move closer together, the flexible tube 202 may be compressed, thereby closing a lumen therein. In contrast, when a button is pressed, the jaws 196, 198 may spread apart. The spreading of the jaws 196, 198 may pull the jaws 214, 216 apart or the jaws 214, 216 may be biased apart by one or more biasing members (e.g., springs). The spreading apart of the jaws 196, 198, 214, 216 may allow for the flexible tube 20 to expand, thereby allowing for a lumen therein to open.

[0076] Attention is now directed to Figures 7A and 7B, which additional embodiments of the hemostasis valve 122. As shown in Figure 7A, the hemostasis valve 122 may include a plurality of valve plates 220. Each of the valve plates 220 includes a notch 222 configured to at least partially surround a flexible tube 224. Each valve plate 220 also includes a cam follower 226. The hemostasis valve 122 also includes a cam plate 228 with a plurality of cam slots 230. The cam follower 226 from each valve plate 220 extends into one of the cam slots 230. The cam plate 228 is rotatable relative to the valve plates 220. For instance,a buton or nob on the handle 116 may be activated (e.g., pressed or rotated) to rotate the cam plate 228. The cam slots 230 are angled such that rotation of the cam plate 228 causes the cam followers 226 to move through the cam slots 230, which causes the valve plates 220 to move closer together or further apart. In some embodiments, the cam plate 228 and / or the valve plates 220 may be biased towards a closed position in which the valve plate 220 compress the flexible tube 224 so a lumen therein is closed. Activating the buton or nob on the handle 116 to rotate the cam plate 228 may overcome the biasing force, and thereby allow for the flexible tube 224 to expand and the opening of the lumen therein.

[0077] Figure 7B illustrates an embodiment that is similar to that of Figure 7A. However, rather than the valve plates 220 moving linearly to open of close the flexible tube 224, the embodiment of Figure 7B employes a pivoting motion of the valve plate. Specifically, the valve of Figure 7B may include a plurality7of valve plates 232, each with a notch 234 therein configured to surround at least a portion of a flexible tube 236. A first end of each valve plate 232 may be pivotally mounted at a pivot 238. A second end of each valve plate 232 may include a cam follower 240. The cam follower 240 may be configured to move through a cam slot 242 is a cam plate 244. Rotation of the cam plate 244 may cause the cam follower 240 to move through the cam slot 242, which can cause the valve plate 232 to pivot about pivot 238. Pivoting of the valve plates 232 in a first direction may cause the valve plates 232 to compress the flexible tube 236, thereby closing a lumen therein. In contrast, pivoting of the valve plates 232 in a second direction may cause the valve plates 232 to move away from the flexible tube 236, thereby allowing the flexible tube 236 to expand and opening the lumen therein. As with the other embodiments, the valve of Figure 7B may be biased to a closed configuration (e.g., via one or more biasing members) and may be activated via a buton or nob on the handle 116.

[0078] Atention is now directed to Figures 8A-8B, which illustrate yet another example embodiment of the hemostasis valve 122. In the illustrated embodiment, the valve includes a plurality of valve plates 246. Each of the valve plates 246 includes a notch 248 configured to surround at least a portion of a flexible tube 250. Each valve plate 246 is mounted at a pivot 252 and about which the valve plate 246 can pivot. The valve plates 246 are interconnected to adjacent valve plates 246 via links 254. At least one of the valve plates 246 is connected to a buton 256. The buton 256 is biased to an extended position via a biasing member 258 disposed between the buton 256 and the housing 144. Pressing the buton 256 can overcome the biasing force of the biasing member 258. Additionally, pressing the buton 256 can cause one of the valve plates 246 to pivot or rotate about itspivot 252. The rotation or pivoting of one valve plate 246 and the links 254 between the valve plates 246 will cause all of the valve plates 246 to similarly pivot or rotate about their respective pivots 252. As shown in Figure 8B, as the valve plates 246 pivot or rotate in a first direction (e.g., as a result of the biasing force of the biasing member 258), the notches 248 in the valve plates 246 will move closer together, thereby compressing and / or twisting the flexible tube 250 so a lumen therein is closed. In contrast, as shown in Figure 8A, pivoting or rotating the valve plates 246 in a second direction (e.g., as a result of pressing the button 256) will cause the notches 248 in the valve plates 246 to move further apart, thereby allowing the flexible tube 250 to expand and open the lumen therein. Figure 8B shows the profile of the flexible tube 250 in the uncompressed state in order to depict the change in the spacing of the valve plates 246 between the positions in Figures 8A and 8B.

[0079] Attention is now directed to Figure 9, which illustrates an example embodiment of the powered vacuum source 138. In the illustrated embodiment, the powered vacuum source may include a control module 260, a vacuum source 262, and a power system 264. The power system 264 may be a battery or a connection to AC or DC power. The vacuum source 262 may be a pump or other device or system configured to generate a negative pressure.

[0080] The control module 260 may include a user interface 266 configured to enable a user to control the operation of the powered vacuum source 138 and / or monitor the operation thereof. The user interface 266 may include one or more user inputs and / or one or more displays. The one or more user inputs may be buttons, nobs, switches, touchscreens, or the like, that enable a user to activate, deactivate, or vary the operating parameters of the vacuum power source 138. The one or more displays may provide information to a user regarding the operational status of the powered vacuum source 138.

[0081] The control module 260 may also include a valve 268 that can be selectively opened or closed to communicate the negative pressure from the vacuum source 262 to the aspiration catheter 104. Additionally, the control module 260 may include one or more sensors 270. 272 to detect pressure or other characteristics. For instance, the sensors 270. 272 may be disposed on opposing sides of the valve 268 to monitor the pressure on each side of the valve 268. Furthermore, the control module 260 may include a controller 274 that is configured to receive readings from the sensors 270, 272, control the operation of the valve 268. and communicate with the user interface 266 to display current operating parameters and receive input regarding desired changes to the operating parameters.

[0082] Atention is now directed to Figure 10, which illustrates a cross-sectional view of an example embodiment of the aspiration catheter 104. As shown, the aspiration catheter 104 includes a multi-layer construction. The multi-layer construction includes an inner liner 280 with the aspiration lumen 120 extending therethrough. Disposed about the liner 280 is a coil 282. The number of turns and the spacing of the coil may be selected to achieve a desired flexibility in the aspiration catheter 104. Disposed around the coil 282 is a working layer 284. A braid 286 or other structure can be disposed about the working layer 284 to increase strength of the aspiration catheter 104. An outer jacket 288 can be disposed over the braid 286. In some embodiments, instead of a braid, a second coil can be placed over the working layer 284 to increase torqueability but still maintain good flexibility. The flexibility can be influenced by the spacing of the coil with wider spacing resulting in more flexibility. The direction of the coiling can determine torqueability. To provide good torque in both directions, the second coil could have a direction opposite of the first coil.

[0083] The working layer 284 may include one or more lumens 290 extending therethrough. The lumens 290 may be configured to provide one or more functions to the aspiration catheter 104. For instance, one or more of the lumens 290 may house steering elements connected between the distal end of the aspiration catheter 104 and the steering controls 124 discussed above. In some embodiments, the steering elements include wires, cables, or the like. Similarly, one or more of the lumens 290 may be configured to communicate an inflation gas or liquid to the inflatable structure. Still further, one or more of the lumens 290 may be configured to communicate a fluid to a nozzle at a distal end of the aspiration catheter 104. The fluid may exit the nozzle to macerate a thrombus to enable the thrombotic material to be more readily drawn through the aspiration lumen 120.

[0084] While reference is made of a multi-layer construction, it will be understood that one or more layers can be omited or combined together. Additionally, one or more of the layers can be formed by extrusion. The various layers can be formed from polymers, metals, alloys, braided structures, coiled structures, and combinations or modifications thereof. Furthermore, the liner 280, the working layer 284, and the outer jacket 288 can be formed of a variety of polymers and copolymers, plastics, PEBAX, HYTREL, rubber, Nylon, polyolefin, fluorinated polymers like FEP or PTFE, polyurethan, polyamides, and combinations or modifications thereof.

[0085] Atention is now directed to Figures 11A-11B, which illustrate an example embodiment of the connection feature 1 14 for selectively connecting the dilator 102 to thedistal end of the aspiration catheter 104. In the illustrated embodiment, the dilator 102 is formed with a coil 292 and an outer jacket 294. The jacket 294 is disposed around the coil 292 such that the coil is disposed within the jacket 294. The coil 292 and the jacket 294 may cooperate to form a guidewire lumen 296 through the dilator 102. As discussed above, the dilator 102 may be advanced into or through a body lumen over a guidewire with the guidewire extending through the guidewire lumen 296. The guidewire lumen may have an inner dimension of about 0.039 inches or more and may be configured to pass over a guidewire having an outer dimension of up to about 0.037 inches.

[0086] The coil 292 may be formed of a round or flat wire coated with low friction material (e.g., PTFE) to reduce friction between the coil 292 and the guidewire. In cases where the guidewire is coated or jacketed with a low friction material (e.g., PTFE), the coil 292 may be a bare coil without any coatings. The wire may have a dimension of between about 0.05 inches to about 0.3 inches or between about 0.1 inches to about 0.15 inches. Additionally, the stiffness of the wire can vary from one embodiment to another and by varying the dimension of the wire. Still further, the coil 292 may be arranged as a fully slagged coil or a pitched coil. In some embodiments, the pitch of the coil can change along the length of the coil so as to vary the stiffness of the coil. In some such cases, the stiffness of the coil can decrease near the distal end of the dilator 102.

[0087] The coil 292 may be attached to the interior surface of the jacket 294 along all or portions of the lengths thereof. In some embodiments, is may be desirable to attach the proximal and / or distal ends of the coil 292 to the proximal and / or distal ends of the jacket 294. In other embodiments, it may be desirable to attach the coil 292 to the jacket 294 along the entire length thereof. In any event, to facilitate the connection(s) of the coil 292 to the jacket 294, it may be desirable to remove any coatings from the coil 292 where the attachment is to take plate. For instance, any coatings on the outer surface of the coil 292 where the attachment to the jacket 294 is to happen may be removed (e.g., via grinding or sandblasting).

[0088] The jacket includes segments 294a, 294b, 294c. 294d along the length thereof. As noted above, the different segments may have differing stiffness or flexibility characteristics. The segments may have similar outer dimensions relative to one another along all or portions of their lengths. As shown, the outer dimensions of the segments 294a-294d may be smaller than the inner dimension of the aspiration lumen 120 such that there can be a gap therebetween.

[0089] In some embodiments, including as shown, the distal segment 294d may include a sealing region 298 that has a larger outer dimension than the rest of the distal segment 294d and that generally corresponds in size to the inner dimension of the aspiration lumen 120. The sealing region 298 may engage the inner surface of the aspiration lumen 120 to create a seal between the dilator 102 and the aspiration lumen 120. The distal end of the aspiration catheter 104 may include a soft tip that is configured to conform to the shape of the sealing region 298 to create the seal between the dilator 102 and the aspiration catheter 104.

[0090] The distal segment 294d may also include a distal region 300 that has a tapered outer contour. The tapered outer contour may facilitate advancement of the dilator 102 through a body lumen.

[0091] The jacket 294 may be formed of any suitable polymer, include a Pebax material. In some embodiments, the jacket 294 may include a material (e.g., Propel) to reduce the frictional characteristics or increase is lubricious characteristics of the jacket 294. In some embodiments, the jacket 294 may be coated with other materials or lubricants (e.g., HP coating).

[0092] The dilator 102 may also include an inflatable structure 302 disposed around at least a portion of the outer surface of the jacket 294. The inflatable structure 302 may be in communication with an inflation lumen 304 extending through the jacket 294. The inflation lumen may be a lumen extending through wall of the jacket 294 or a lumen disposed between the coil 292 and the jacket 294.

[0093] The inflatable structure 302 may be formed of an elastic balloon material. In some embodiments, the inflatable structure 302 is formed of a material that is relatively sticky or has a high relatively coefficient of friction. For instance, the inflatable structure 302 may be formed from a TPU or silicon material. In other embodiments, the inflatable structure 302 may be coated with a material that is relatively sticky or has a high relatively coefficient of friction.

[0094] The inflatable structure 302 may be selectively moved between an uninflated or undeployed configuration, as shown in Figure HA, and an inflated or deployed configuration, as shown in Figure 1 IB. When in the uninflated configuration, the inflatable structure 302 may be recessed within a groove or channel 306 in the outer surface of the jacket 294. In contrast, when the inflatable structure 302 is in the inflated configuration, the inflatable structure 302 may extend out of the channel 306 and engage the inner surface of the aspiration lumen 120. When so engaged, the friction between the inflatable structure302 and the aspiration lumen 120 may secure the dilator 102 and the aspiration catheter 104 together. As a result, pushing the dilator 102 through a body lumen can pull the aspiration catheter 104 along with the dilator 102. This can be particularly useful when the aspiration catheter 104 (or the distal end thereof) is highly flexible and would otherwise tend to bend or curl when being pushed through a body lumen.

[0095] A fluid (gas or liquid) may be introduced from the inflation lumen 304 into the inflatable structure 302 to cause the inflatable structure 302 to inflate from the undeployed configuration in Figure 11 A to the deployed configuration in Figure 1 IB. In contrast, the fluid may be withdrawn from the inflatable structure 302 through the inflation lumen 304 to cause the inflatable structure 302 to return to the undeployed configuration of Figure 11A.

[0096] Figure 11C illustrates another embodiment of the connection feature 114 for selectively connecting the dilator 102 to the distal end of the aspiration catheter. The embodiment of Figure 11C is substantially the same as that of Figures 11A and 11B. Accordingly, the following discussion of Figure 11C will focus on the aspects that are different from Figures 1 1 A and 1 IB.

[0097] As shown, the jacket 294 may also include one or more ridges, ribs, or protrusions 310 on an outer surface thereof. The protrusions 310 may extend around all or a portion of the circumference of the jacket 294. Additionally, when multiple protrusions 310 are included, the protrusions 310 may be spaced apart from one another along all or along one or more portions of the length of the jacket 294. The one or more protrusions 310 may be integrally formed with the jacket 294 or may be formed separately and attached thereto. The protrusions 310 may help to center the dilator 102 within the aspiration lumen 120. As a result, the friction between the dilator 102 and the interior of the aspiration lumen 120 can be reduced.

[0098] The dilator 102 of Figure 11C also includes the coil 292 disposed within the wall of the jacket 294. In some cases, the jacket 294 includes a channel therein for receiving the coil 292 therein. In other embodiments, the jacket 294 may be a multi-layer construction. For instance, the jacket 294 may include an inner layer and an outer layer and the coil 292 may be disposed between the inner and outer layers thereof.

[0099] Attention is now directed to Figures 12 and 13, which illustrate a cross- sectional view of the distal end of an example embodiment of the aspiration catheter 104. The illustrated embodiment may be a simplified version that does not illustrate all of the various features and layers that could be included.

[0100] The aspiration catheter 104 includes a wall 350 with one or more inflation lumens 290 extending therethrough. The RO marker 133 is disposed at the distal end of the aspiration catheter 104. In the illustrated implementation, the aspiration catheter 104 includes an inflatable structure 132. The inflatable structure 132 may comprise a balloon (also referred to as balloon 132) mounted on the outer surface of the aspiration catheter 104. The balloon 132 can extend around all or a substantial portion of the outer circumference of the distal end of the aspiration catheter 104. The balloon 132 may be formed of any suitable material, including polyethylene (PE), polyurethane (PU), thermoplastic polyurethan (TPU) polyethylene terephthalate (PET), polyether block amide (PEBAX), nylon, silicon, rubber, and the like.

[0101] The balloon 132 may me selectively moved from an undeployed or deflated configuration to a deployed or inflated configuration. Figure 12 illustrates the balloon 132 in the undeployed or deflated configuration and Figure 13 illustrates the balloon 132 in the deployed or inflated configuration. In the undeployed or deflated configuration, the balloon 132 may generally conform to the shape of the outer surface of the aspiration catheter 104, such that the balloon 132 lays generally flat on the aspiration catheter 104. In other implementations, the balloon 132 may be folded or rolled on the outer surface of the aspiration catheter 104 when the balloon 132 is in the undeployed or deflated configuration.

[0102] In the illustrated embodiment, an outer surface of a distal end 352 of the balloon 132 is attached to the aspiration catheter 104. Thereafter, the balloon 132 may be rolled or folded back over the distal end 352 and an inner surface at the proximal end 358 thereof may be attached to the aspiration catheter 104. In the illustrated implementation, the distal end 352 is attached to the outer surface of the aspiration catheter 104. In other implementations, the distal end 352 of the balloon 132 may be rolled or folded into the open end 354 and attached to an interior surface of the aspiration catheter 104. In either case, rolling or folding the distal end 352 under can create a rounded distal region 356 of the balloon 132 when the balloon 132 is inflated as shown in Figure 13. In the illustrated implementation, the rounded distal region 356 may extend from or beyond the terminal end of the aspiration catheter 104. Furthermore, the distal region 356, when inflated, may form a funnel or conical shape that is configured to direct thrombotic material into the aspiration lumen 120.

[0103] When the balloon 132 is in the deployed or inflated configuration, as shown in Figure 13, the proximal end 358 of the balloon 132 may taper in the proximal direction,creating a ramp. The distal and proximal ends 352, 358 of the balloon 132 may be attached to the aspiration catheter 104 through any suitable modality, including heat bonding, laser or ultrasonic welding, adhesive, or the like. In some implementations, such as when the balloon 132 is formed of silicon, a suture, wire, or other string may be secured around the distal and / or proximal ends 358, 352 of the balloon 132 to help create a fluid tight seal between the balloon 132 and the aspiration catheter 104. Silicon can be difficult to bond to other materials in a way that creates a fluid tight seal, so using a suture or other string in addition to or as an alternative to heat bonding, laser or ultrasonic welding, or adhesives may create the desired fluid tight seal.

[0104] The interior of the balloon 132 may be in fluid communication with the inflation lumen(s) 290 via one or more inflation ports 360. While the inflation lumen(s) 290 are illustrated as extending through the catheter wall 350, the inflation lumen(s) 290 may alternatively extend along the outer surface of the aspiration catheter 104 between an inflation device and the balloon 132. In any event, the inflation lumen(s) 290 may communicate air, CO2, or other fluids between the inflation device and the balloon 132 to inflate or deflate the balloon 132.

[0105] The balloon 132 may have various coatings applied thereto. Such coatings may include lubricants to facilitate movement of the balloon through the vessel lumen. When the balloon 132 is formed of a soft material, such as PU, Pebax, or silicon, it can be particularly useful to coat the balloon 132 with a lubricant, whether hydrophilic or hydrophobic, to enable the balloon 132 to move more easily through a body lumen. Such soft balloon materials can be sticky when not coated with a lubricant. Other coatings may improve the biocompatibility of the balloon 132, provide drug delivery', or have antimicrobial properties.

[0106] Figures 14-17 illustrate an example method of using the system 100. As show n in Figure 14, for instance, the aspiration catheter 104 may be inserted into a lumen of a vessel 362 (or other body) and advanced until the distal end thereof is positioned adjacent to or against a thrombus. The insertion of the aspiration catheter 104 may be accomplished with the dilator 102. More specifically, the dilator 102 may be inserted into the aspiration lumen 120 and secured to the distal end of the aspiration catheter 104 via the connection feature 114.

[0107] Because the distal region of the aspiration catheter 104 is very soft and flexible, pushing the aspiration catheter 104 into position may be quite challenging as the distal region will tend to bend and curl. With the dilator 102 disposed within the aspirationcatheter 104, the dilator 102 will prevent the distal region of the aspiration catheter 104 from undesirably bending or curling. Also, because the dilator 102 is connected to the distal end of the aspiration catheter 104, as the dilator 102 is pushed through the body lumen, the dilator 102 will pull the aspiration catheter 104 along therewith.

[0108] Once the aspiration catheter 104 is positioned as desired with the body lumen, the dilator 102 may be disconnected from the aspiration catheter 104. For instance, a user input on the handle 116 may be used to cause the connection feature 114 on the dilator 102 to disconnect from the aspiration catheter 104. By way of example, activating the user input on the handle 116 may cause an inflatable structure (see Figures 11A-11C) of the connection feature 114 to deflate, thereby disconnecting the dilator 102 from the aspiration catheter 104. With the dilator 102 disconnected from the aspiration catheter 104, the dilator 102 may be withdrawn from the aspiration catheter 104, as shown in Figure 15.

[0109] As shown in Figure 16, the balloon 132 may be inflated to cause the balloon 132 to engage the wall of the body lumen and hold the distal end of the aspiration catheter 104 in place within the body lumen. The balloon 132 may be inflated before or after the dilator 102 is disconnected from the aspiration catheter 104 and removed therefrom.

[0110] With the aspiration catheter 104 so positioned and the balloon 132 inflated, aspiration may be commenced, as shown in Figure 16. Aspiration may include evacuating (via vacuum) the thrombus through the aspiration lumen 120.

[0111] Once the aspiration procedure is completed, the balloon 132 may be deflated by evacuating the inflation fluid therefrom through the one or more inflation lumens 290. As shown in Figure 17, a sheath 364 may optionally be advanced over the aspiration catheter 104. The sheath 364 may be advanced over the balloon 132 to help deflate the balloon 132 and contain the balloon 132 while the aspiration catheter 104 is withdrawn from the body lumen.

[0112] Attention is now directed to Figures 18-25B, which illustrate various view of an example embodiment of a handle 116’ that may be used with the system 100 of Figure 1. As shown in Figure 18. the handle 116’ includes a housing 400, a steering input 402, a vacuum port 404. a vacuum port valve input 406, a hemostasis valve port 408, and a hemostasis valve input 410. Other embodiments of the handle 116’ may include less than or more than the noted features.

[0113] The steering input 402 may be connected to the distal end of the shaft 118 of the aspiration catheter 104 (e.g., via one or more steering elements) to enable steering of the distal end of the shaft 118. The steering input 402 may be rotated relative to the housing400 in one or more directions to engage the one or more steering elements and cause the distal end of the shaft 118 to bend in a desire direction, thereby enabling the distal end of the shaft 1 18 to be steered in a desired direction. In some embodiments, the steering input 402 may rotate about a longitudinal axis of the handle 116’.

[0114] The vacuum port 404 may be configured for fluid communication with the aspiration lumen 120 in the aspiration catheter 104. The vacuum port valve input 406 may be a lever, switch, button, or other user interface that can activate, deactivate, or adjust the level of vacuum pressure applied to the aspiration lumen 120 via the vacuum port 404. In some embodiments, for instance, the vacuum port valve input 406 may be operatively associated with a vacuum port valve within the handle 116’. The vacuum port valve input 406 may be used to selectively open and close, partially or entirely, the vacuum port valve to control the vacuum pressure communicated to the aspiration lumen 120 by the manual or powered vacuum source 134, 138.

[0115] The hemostasis valve input 410 may be configured to control the hemostasis valve 122. For instance, the hemostasis valve input 410 may be configured to allow for selective opening and closing of the hemostasis valve 122. In the illustrated embodiment, the hemostasis valve input 410 comprises a button 412 that is positioned on a side of the housing 400. Pressing the button 412 may cause the hemostasis valve 122 to open. In contrast, removing external pressure from the button 412 may cause the hemostasis valve 122 to close.

[0116] As can be seen in Figure 18, the housing 400 may include a projection 414. The projection 414 may extend from a side of the housing 400 opposite to the button 412. As discussed in greater detail below, the projection 414 may have a cavity therein that is configured to receive a portion of the button 412 therein when the button 412 is pressed.

[0117] Attention is now directed to Figures 19-23, which illustrate additional details regarding the hemostasis valve 122 and the hemostasis valve input 410 and the operation for opening and closing the hemostasis valve 122. Figures 19-21 illustrate a perspective view of the handle 116’ with a portion of a handle housing or cover being removed to reveal internal components of the handle 116’.

[0118] As shown in Figure 19, the hemostasis valve 122 includes a frame 416 that is mounted in the handle 116’ in a stationary position. The hemostasis valve 122 also includes a shaft 418. The shaft 418 includes a lumen extending therethrough. The lumen through the shaft 418 is in fluid communication with the hemostasis valve port 408. The shaft 418 also includes a plurality of gear teeth 420 disposed on an outer surface thereof. As show nin Figure 19, the gear teeth 420 mate with recesses 421 on the button 412. Movement of the button 412 causes the gear teeth 420 and the recesses 421 to engage in a manner that causes the shaft 418 to rotate about its longitudinal axis. As will be discussed in more detail below, the shaft 418 can rotate relative to the frame 416 and the rotation of the shaft 418 opens and closes the hemostasis valve 122.

[0119] Figures 20 and 21 illustrate similar views as those of Figure 19. However, the frame 416 is removed in Figures 20 and 21 to show additional aspects of the hemostasis valve 122. As can be seen, the hemostasis valve 122 also includes a mount 422 and a valve conduit 424. As described in greater detail below, the mount 422 may be selectively or permanently connected to the frame 416 in a stationary configuration relative thereto. The mount 422 includes a lumen therethrough that is in fluid communication with the aspiration lumen 120 in the aspiration catheter 104.

[0120] The valve conduit 424 may be connected between the shaft 418 and the mount 422. The valve conduit 424 includes a lumen extending therethrough. The lumen through the valve conduit 424 may be selectively opened and closed to provide or close off fluid communication between the lumens in the shaft 418 and the mount 422. Briefly, the lumen through the valve conduit 424 may be opened by rotating the shaft 418 in a first direction and closed by rotating the shaft 418 in a second direction. Because one end of the valve conduit 424 is connected to the fixed mount 422 and a second end is connected to the movable shaft 418, the rotation of the shaft 418 will cause the second end of the valve conduit 424 to rotate relative to the first end of the valve conduit 424. The relative rotation between the first and second ends of the valve conduit 424 cause the valve conduit 424 to twist open or closed depending on the direction of rotation.

[0121] Figure 20 shows the valve conduit 424 in a closed configuration. This can be seen by the twist in the valve conduit 424. In contrast, Figure 21 shows the valve conduit 424 in an open configuration. This can be seen by the straight configuration of the valve conduit 424. The button 412 may be used to move the valve conduit 424 between the open and closed configurations. For instance, moving the button 412 from the extended position shown in Figure 20 to the pressed position shown in Figure 21 will cause the shaft 418 to rotate and cause the valve conduit 424 to untwist and move to the open configuration. In contrast, moving the button 412 from the pressed position shown in Figure 21 to the extended position shown in Figure 20 will cause the shaft 418 to rotate in the opposite direction and cause the valve conduit 424 to twist and move to the closed configuration.

[0122] Figures 22A and 22B illustrate a cross-sectional view of the handle 116’ to illustrate additional details regarding the hemostasis valve input 410. Figure 22A illustrates the hemostasis valve input 410 with the button 412 in the extended position similar to Figure 20, and Figure 22B illustrates the hemostasis valve input 410 with the button 412 in the pressed position similar to Figure 21. As can be seen, the projection 414 has an open interior chamber 426 that is configured to receive at least a portion of the button 412 there, particularly, when the button 412 is moved to the pressed position shown in Figure 23B.

[0123] The hemostasis valve input 410 also includes a biasing mechanism that is configured to bias the button 412 towards the extended position. In the illustrated embodiment, the biasing mechanism includes a spring 428 and a spring pre-load shaft 430. The button 412 includes an interior chamber 432. The spring pre-load shaft 430 is mounted within the interior chamber 426 of the projection 414. The spring pre-load shaft 430 may extend into the interior chamber 432 of the button 412, particularly as the button 412 is moved from the extended position to the pressed position. The spring pre-load shaft 430 includes a shoulder 434. The spring 428 is positioned within the interior chamber 432 of the button 412. The spring 428 is disposed between the shoulder 434 and a surface in the interior chamber 432 of the button 412. The spring 428 is thereby configured to bias the button 412 to the extended position.

[0124] As noted above, movement of the button 412 results in the rotation of the shaft 418 and, in turn, the opening or closing of the valve conduit 424. The noted biasing mechanism may be arranged so as to bias the valve conduit 424 to the closed configuration. For instance, biasing the button 412 to the extended position may cause the shaft 418 to rotate in a direction that will cause the valve conduit 424 to rotate to the closed position. In other embodiments, however, biasing the button 412 to the extended position may cause the shaft 418 to rotate in a direction that will cause the valve conduit 424 to rotate to the open position.

[0125] Figures 23A and 23B illustrate an alternative embodiment of a hemostasis valve input 410'. Figure 23A illustrates the hemostasis valve input 410’ with the button 412’ in the extended position similar to Figure 20, and Figure 23B illustrates the hemostasis valve input 410’ with the button 412’ in the pressed position similar to Figure 21. As with the hemostasis valve input 410, the hemostasis valve input 410’ may also include a biasing mechanism that is configured to bias the button 412' towards the extended position. The biasing mechanism may be the same as or similar to the springbased biasing mechanism shown in Figures 22A and 22B.

[0126] In contrast to the gear teeth 420 and recesses 421 of the hemostasis valve input 410, the hemostasis valve input 410’ uses a cable-based mechanism to translate linear movement of the button 412’ to rotational movement of the shaft 418’. More specifically, the hemostasis valve input 410’ may include a cable 435 connected between the button 412’ and the shaft 418’. A first end of the cable 435 may be connected to the button 412’ adjacent to an end of the button 412’ opposite to the end of the button 412' that is engaged by a user. A second end of the cable 435 may be connected to the shaft 418’. When the button 412’ is in the extended position as shown in Figure 23A, the cable 435 may be wrapped around at least a portion of the circumference of the shaft 418’. As the button 412’ is moved to the pressed position shown in Figure 23B, at least a portion of the cable 435 may be unwrapped from around the shaft 418’. The movement of the button 412’ from the extended position to the pressed position will cause the button 412’ to pull on the cable 435, which will result in the rotation of the shaft 418’. As discussed above, rotation of the shaft 418’ will result in the opening or closing of the valve conduit 424.

[0127] Figures 24A and 24B illustrate partially exploded views of the hemostasis valve 122 apart from the rest of the handle 116’. Specifically, Figures 24A and 24B illustrate opposing perspective views with the frame 416 removed from the rest of the hemostasis valve 122. As can be seen in Figure 24A, a first end of the frame 416 includes a recess 436 configured to receive a portion of the shaft 418 therein. Similarly, as can be seen in Figure 24B. a second end of the frame 416 includes a recess 438 configured to receive a portion of the mount 422 therein. The shaft 418 and mount 422 may include bushings 440, 442, respectively. The bushings 440, 442 may be used to secure the opposing ends of the valve conduit 424 to the shaft 418 and mount 422. The bushings 440, 442 may also engage with the recesses 436. 438, respectively.

[0128] In the illustrated embodiment, the recesses 436, 438 and bushings 440, 442 may have generally circular shapes. However, the recesses 436, 438 may not form complete circles. For instance, the recesses 436, 438 may also extend between about 190° and about 320°. Additionally, the frame 416 may include a slot 444 therein. The slot 444 may be configured to allow for the valve conduit 424 to be inserted into the frame. The tension between the shaft 418 and the mount 422 provided by the valve conduit 424 may selectively hold the shaft 418 and the mount 422 with the recesses 436, 438. Additionally, the recesses 436, 438 being over 180° can limit or prevent the shaft 418 and mount 422 from inadvertently moving laterally out of the recesses 436, 438.

[0129] The frame 416, shaft 418, and mount 422 may include stop features that limit or prevent relative rotation therebetween. For instance, the first end of the frame 416 includes a stop 446 and the shaft 418 includes a corresponding stop 448. The stops 446, 448 may interact with one another to limit the degree to which the shaft 418 can rotate relative to the frame. Similarly, the second end of the frame 416 includes stops 450, 452 and the mount 422 includes corresponding stops 454, 456. The stops 450, 454 and stops 452. 456 interact with one another to substantially prevent the mount 422 from rotating relative to the frame 416.

[0130] Figures 25A and 25B illustrate the valve conduit 424 in the opened and closes positions, respectively. Figure 25A illustrates end and plan views of the hemostasis valve 122 (without the frame 416) in the open configuration. More specifically, the shaft 418 is rotated relative to the mount 422 so that the valve conduit 424 is in a straight configuration so that the lumen extending therethrough is open. In contrast, Figure 25B illustrates end and plan views of the hemostasis valve 122 (without the frame 416) in the closed configuration. More specifically, the shaft 418 is rotated relative to the mount 422 so that the valve conduit 424 is in a twisted configuration so that the lumen extending therethrough is closed.

[0131] Attention is now directed to Figures 26A-26D, which illustrate various view of an example embodiment of a handle 116” that may be used with the system 100 of Figure 1. As shown, the handle 116” includes a housing 470, a hemostasis valve port 472, and a hemostasis valve input 474. Figures 26A and 26B illustrate the handle 1 16” with a portion of the housing 470 removed to show a hemostasis valve 476 and a gear system 478 that connects the hemostasis valve input 474 to the hemostasis valve 476. Other embodiments of the handle 116” may include additional or alternative features.

[0132] The hemostasis valve input 474 may be configured to control the hemostasis valve 476. For instance, the hemostasis valve input 474 may be configured to allow for selective opening and closing of the hemostasis valve 476. In the illustrated embodiment, the hemostasis valve input 410 comprises a button that extend proximally from an end of the housing 470. Moving the button from an extended position (Figure 26A) to a pressed position (Figure 26B) may cause the hemostasis valve 476 to open. In contrast, moving the button from the pressed position to the extended position (e.g., by removing external pressure on the button) may cause the hemostasis valve 476 to close.

[0133] The hemostasis valve 476 may be substantially similar to the hemostasis valve 122 discussed above. For instance, the hemostasis valve 476 may include a shaft 480, amount 482 and a valve conduit (disposed inside of the housing 484) extending therebetween. Similar to the hemostasis valve 122, the mount 482 may be mounted in a fixed position within the housing 470. In contrast, the shaft 480 may rotate about a longitudinal axis and relative to the mount 482. Rotation of the shaft 480 twist the valve conduit open and closed.

[0134] As best seen in Figures 26C and 26D, the hemostasis valve 476 and the hemostasis valve input 474 are oriented relative to one another such that they form an acute angle therebetween. The gear system 478 interconnects the hemostasis valve 476 and the hemostasis valve input 474 such that movement of the hemostasis valve input 474 causes the hemostasis valve 476 to open and close.

[0135] In the illustrated embodiment, gear system 478 includes a beveled gear 486 disposed around the shaft 480. The gear system 478 also includes a compound gear 488 that includes a beveled gear 490 at a first end thereof and a pinion gear 492 at a second end thereof. Teeth of the pinion gear 492 are configured to engage with recesses 494 on the hemostasis valve input 474. Thus, movement of the hemostasis valve input 474 will cause the pinion gear 492 to rotate. Rotation of the pinion gear 492 likewise causes the beveled gear 490 to rotate. Teeth of the beveled gear 490 mate with teeth of the beveled gear 486. Therefore, rotation of the beveled gear 490 causes the beveled gear 486 to rotate, which results in the opening or closing of the hemostasis valve 476.

[0136] The hemostasis valve input 474 also includes a biasing mechanism that is configured to bias the button towards the extended position. In the illustrated embodiment, the biasing mechanism includes a spring 496 disposed within an interior chamber of the button. When the button is moved to the pressed position, the spring 496 may be compressed. When the external force is removed from the button, the spring 496 may expand and move the button to the expanded position.

[0137] Attention is now directed to Figure 27, which illustrates an example embodiment of a handle 116”’ that may be used with the system 100 of Figure 1. The handle 116’” may be substantially similar to the handle 116”. Accordingly, the following discussion will focus on those aspects that are unique to the handle 116’”. In the following discussion, elements of the handle 11 ’” that are similar to those of the handle 116’” will be designated with similar reference numbers with the addition of an apostrophe.

[0138] As shown, the handle 116” includes a housing 470’, a hemostasis valve port 472’, a hemostasis valve input 474’, a hemostasis valve 476’, and a gear system 478’ thatconnects the hemostasis valve input 474’ to the hemostasis valve 476'. Other embodiments of the handle 116” may include additional or alternative features.

[0139] Two differences between the handle 1 16’” and the handle 116” are the orientation of the hemostasis valve input 474’ relative to the hemostasis valve 476’ and the components of the gear system 478’. As shown, the hemostasis valve input 474’ is oriented generally parallel to the hemostasis valve 476’ rather than at an acute angle. Similar to the gear system 478, the gear system 478’ includes a beveled gear 486’ mounted on the shaft 480’ and a pinion gear 492’ that is configured to engage with the hemostasis valve input 474’.

[0140] The gear system 478 also includes intermediate gears between the beveled gear 486’ and the pinion gear 492’. In the illustrated embodiment, the intermediate gears include another beveled gear 490’ and a reduction gear 498. The reduction gear 498 and the pinion gear 492’ are mounted on a common shaft or are otherwise linked together such that they rotate together. The another beveled gear 490’ engages with the beveled gear 486’ and the reduction gear 498. Thus, movement of the hemostasis valve input 484’ causes the pinion gear 492’ to rotate, which causes the reduction gear 498 to rotate, which causes the another beveled gear 490’ to rotate, which causes the beveled gear 486’ and the shaft 480’ to rotated, which causes the hemostasis valve 176’ to open or close.

[0141] Attention is now directed to Figure 28, which illustrates another handle 116”” that may be used with the system 100 of Figure 1. As shown, the handle 116”” includes a housing 470”, a hemostasis valve port 472”, a hemostasis valve input 474”, a hemostasis valve 476”, and a pulley system 500 that connects the hemostasis valve input 474” to the hemostasis valve 476”. Other embodiments of the handle 116”” may include additional or alternative features.

[0142] In the illustrated embodiment, the hemostasis valve input 474” is a slider that is configured to slide along a portion of the length of the housing 470”. The hemostasis valve input 474” is connected to the shaft 502 of the hemostasis valve 476” by a cable 504. The cable 504 is trained around a plurality of pulleys from the pulley system 500.

[0143] In the illustrated embodiment, the cable 504 is connected to and extends distally from the hemostasis valve input 474”, w raps around a first pulley 506, and extends proximally from the first pulley 506. The cable 504 then wraps around a second pulley 508 and engages with the shaft 502. The cable 504 may wrap around the shaft 502 less than a full circumference thereof or one or more full or partial times therearound. At leasta portion of the cable 504 may be fixedly connected to the shaft 502, such that movement of the cable 504 causes the shaft 502 to rotate.

[0144] After warping around the shaft 502, the cable extends to and wraps around a third pulley 510 and then connects to the hemostasis valve input 474”. Movement of the hemostasis valve input 474” relative to the housing causes the cable 504 to move over the pulley system 500. In some embodiments, the pulleys 506. 508, 510 are configured to rotate to facilitate movement of the cable 504. In other embodiments, the pulleys 506, 508. 510 are formed of low friction materials that allow the cable 504 to slide therearound with minimal resistance and without the pulleys 506, 508, 510 rotating. In cases where the pulleys 506, 508, 510 rotate, the first pulley 506 may be configured to rotate about a first axis and the second and third pulleys 58. 510 may be configured to rotated about one or more other axes. In some embodiments, the one or more other axes are perpendicular to the first axis.

[0145] Regardless of the specific configuration of the pulley system 500. the pulley system 500 and the cable 504 may be configured to translate movement of the hemostasis valve input 474” into rotational movement of the shaft 502. As with previous embodiments, rotational movement of the shaft 502 is configured to open or close the hemostasis valve 476”.

[0146] Attention is now directed to Figures 29A-29D, which illustrate another handle 116””” that may be used with the system 100 of Figure 1. As shown, the handle 116’”” generally includes a housing 470’”, a hemostasis valve port 472’”, a hemostasis valve input 474’”, and a hemostasis valve 476’”. Other embodiments of the handle 116’”” may include additional or alternative features.

[0147] As shown in Figures 29B-29D, the hemostasis valve 476’” includes a shaft 520. The shaft 520 is mounted within the housing 47 O’” such that the shaft 520 is able to rotate about a longitudinal axis of the shaft 520. As with the shafts of the other hemostasis valves described herein, rotation of the shaft 520 is configured to open or close the hemostasis valve 476”’.

[0148] A second shaft 522 is also mounted in the housing 470’” . The second shaft 522 may be similar to the shaft 520. The shaft 522 may rotate within the housing 470’” around a longitudinal axis of the shaft 522. The axes about which the shafts 520, 522 rotate may be parallel to one another. Unlike the shaft 520 is may be is fluid communication with the hemostasis valve port 472’”, the shaft 522 may not be in fluid communication with the hemostasis valve port 472’”.

[0149] In the illustrated embodiment, the hemostasis valve input 474'” may take the form of a zipper button. In particular, the hemostasis valve input 474"’ may include an engagement portion 524 that is configured to be engaged and pressed by a user. As best illustrated in the cross-sectional views of Figures 29C and 29D, the hemostasis valve input 474’'’ may also include first and second zipper columns 526, 528. The first and second zipper columns 526, 528 may each have an upper end thereof that is connected or otherwise associated with the engagement portion 524. A lower end of the first zipper column 526 may be connected to the shaft 520 and a lower end of the second zipper column 528 may be connected to the shaft 522.

[0150] The first and second zipper columns 526, 528 may each include teeth that are configured to mate with each other. The first and second zipper columns 526, 528 may be made of flexible materials to enable the first and second zipper columns 526, 528 to wrap around the shafts 520, 522, respectively. For instance, as shown in Figure 29D, when external pressure is applied to the engagement portion 524, the shafts 520, 522 may rotate within the housing 470’”. Because the lower ends of the first and second zipper columns 526, 528 are connected to the shafts 520, 522 respectively, rotation of the shafts 520, 522 will cause the first and second zipper columns 526, 528 to wrap around the shafts 520, 522 respectively. The rotation of the shaft 520, via movement of the first zipper column 526, will cause the hemostasis valve 476”' to open or close.

[0151] The present embodiment allows for the hemostasis valve input 474’” to move from an extended position (Figures 29A-29C) to a pressed position (Figure 29D) without the hemostasis valve input 474’” extending through or out of the housing 470’” on an opposite side. That is. the hemostasis valve input 474'” may only extend from or out of one side of the housing 470’”. Furthermore, the housing does not require a projection (similar to projection 414).

[0152] While some of the embodiments herein have been described in the context of aspiration thrombectomy, it will be appreciated that aspiration thrombectomy is only referenced as an example. The embodiments herein may be used during a variety’ of other procedures. For instance, the disclosed hemostasis valves and related components that allow for selective opening and closing of the hemostasis valves may be used with other types of procedures. In some embodiments, the disclosed hemostasis valves and related opening / closing mechanisms may be well suited to use in connection with introducing relatively large devices into a catheter and providing a seal at the entry point into the catheter. Merely by way of example, such large devices may include, but are not limitedto, large balloon valvuloplasty devices, structural heart devices, intravenous lithotripsy devices, heart valve repair / replacement devices, pacemakers, percutaneous heart pumps, implantable devices, left ventricular assist devices, and the like.

[0153] It is contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments disclosed above may be made and still fall within one or more of the embodiments. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with an embodiment can be used in all other embodiments set forth herein. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed embodiments. Thus, it is intended that the scope of the present disclosure herein disclosed should not be limited by the particular disclosed embodiments described above. Moreover, while the present disclosure is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the present disclosure is not to be limited to the particular forms or methods disclosed, but to the contrary, the present disclosure is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication.

[0154] The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as "up to.” "at least,” “greater than.” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “approximately”, “about”, and “substantially” as used herein include the recited numbers (e.g., about 10%=l 0%), and also represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount.

[0155] For purposes of the present disclosure and appended claims, the conjunction “or” is to be construed inclusively (e.g., “an apple or an orange” would be interpreted as “an apple, or an orange, or both”; e.g., “an apple, an orange, or an avocado” would beinterpreted as "an apple, or an orange, or an avocado, or any two, or all three”), unless: (i) it is explicitly stated otherwise, e.g.. by use of “either... or,” “only one of,” or similar language; or (ii) two or more of the listed alternatives are mutually exclusive within the particular context, in which case “or” would encompass only those combinations involving non-mutually-exclusive alternatives. For purposes of the present disclosure and appended claims, the words “comprising,” “including.” “having,” and variants thereof, wherever they appear, shall be construed as open-ended terminology, with the same meaning as if the phrase “at least” were appended after each instance thereof.

[0156] Following are some further example embodiments of the invention. These are presented only by way of example and are not intended to limit the scope of the invention in any way. Further, any example embodiment can be combined with one or more of the example embodiments.

[0157] Embodiment 1. A catheter system comprising: a catheter having a proximal end, a distal end, and a lumen extending therethrough between the proximal and distal ends; and a handle attached to the proximal end of the catheter, the handle comprising a hemostasis valve, the hemostasis valve comprising: a shaft having a lumen extending therethrough; a mount having a lumen therethrough; and a valve conduit having a first end attached to the shaft, a second end attached to the lumen, and a lumen extending therethrough, wherein the shaft is rotatable relative to the mount between a first position and a second position, wherein the lumen in the valve conduit is open when the shaft is in the first position and closed when the shaft is in the second position.

[0158] Embodiment 2. The catheter system of embodiment 1, wherein the mount is disposed in a fixed position within the handle.

[0159] Embodiment 3. The catheter system of any of embodiments 1-2. wherein rotation of the shaft to the second position causes the first end of the valve conduit to rotate relative to the second end of the valve conduit, thereby twisting the valve conduit and closing the lumen extending therethrough.

[0160] Embodiment 4. The catheter system of any of embodiments 1-3, further comprising a hemostasis valve input that is configured to move the hemostasis valve between opened and closed configurations.

[0161] Embodiment 5. The catheter system of embodiment 4, wherein the hemostasis valve input comprises a button that is selectively movable between an extended position and a pressed position.

[0162] Embodiment 6. The catheter system of embodiment 5, wherein the button is operationally connected to the shaft such that movement of the button and the shaft are linked together.

[0163] Embodiment 7. The catheter system of embodiment 6, wherein the button comprises a plurality of recesses and the shaft comprises a plurality of gear teeth that are configured to engage the plurality of recesses.

[0164] Embodiment 8. The catheter system of embodiment 6, wherein the button and the shaft are connected together by a cable, wherein the cable extends around at least a first portion of a circumference of the shaft when the button is in the extended position, and wherein the cable extends around at least a second, smaller portion of the circumference of the shaft when the button is in the pressed position.

[0165] Embodiment 9. The catheter system of any of embodiments 1-8, wherein the hemostasis valve further comprises a frame.

[0166] Embodiment 10. The catheter system of embodiment 9, wherein the frame comprises a first recess configured to receive the shaft at least partially therein, and a second recess configured to receive the mount at least partially therein.

[0167] Embodiment 11. The catheter system of embodiment 10, wherein the frame further comprises a slot therein, the slot being configured to have the valve conduit inserted therethrough during assembly of the hemostasis valve.

[0168] Embodiment 12. The catheter system of any of embodiments 9-11, wherein the frame comprises one or more stops configured to limit rotation of the shaft and prevent rotation of the mount.

[0169] Embodiment 13. A valve comprising: a frame; a shaft having a lumen extending therethrough, the shaft being rotatably associated with the frame; a mount having a lumen therethrough, the mount being associated with the frame in a fixed position relative to the frame; and a valve conduit having a first end attached to the shaft, a second end attached to the lumen, and a lumen extending therethrough, wherein the shaft is rotatable relative to the frame and the mount between a first position and a second position, wherein the lumen in the valve conduit is open when the shaft is in the first position and closed when the shaft is in the second position.

[0170] Embodiment 14. The valve of embodiment 13, further comprising a valve input that is configured to cause the shaft to rotate in order to open and close the valve conduit.

[0171] Embodiment 15. The valve of embodiment 14, wherein the valve input comprises a button that is configured to move linearly and cause the shaft to rotate about a longitudinal axis.

[0172] Embodiment 16. An aspiration system comprising: a dilator having a shaft with a guidewire lumen extending therethrough and a connection feature at a distal end thereof; and an aspiration catheter comprising a shaft having an aspiration lumen extending therethrough, the aspiration lumen being configured to have the dilator disposed therein and selectively connected to a distal end of the aspiration catheter.

[0173] Embodiment 17. The aspiration system of embodiment 16, wherein the dilator comprises or is configured to have a hemostasis valve connected at a proximal end thereof, the hemostasis valve being configured to control a flow of fluid into or out of the guidewire lumen in the dilator.

[0174] Embodiment 18. The aspiration system of embodiment 16 or 17, wherein the shaft of the aspiration catheter comprises a plurality of segments.

[0175] Embodiment 19. The aspiration system of embodiment 18, wherein the plurality of segments comprises a first segment, a second segment, and a third segment.

[0176] Embodiment 20. The aspiration system of embodiment 19, wherein the first segment has a first shore hardness, the second segment has a second shore hardness, and the third segment has a third shore hardness.

[0177] Embodiment 21. The aspiration system of embodiment 20, wherein the first shore hardness is harder than the second shore hardness, and the second shore hardness is harder than the third shore hardness.

[0178] Embodiment 22. The aspiration system of embodiment 20 or 21, wherein the first shore hardness is about 72D, the second shore hardness is about 55D, and the third shore hardness is about 25D.

[0179] Embodiment 23. The aspiration system of any of embodiments 19-22, wherein the third segment is configured to bend to a radius of about 20 mm without a kink.

[0180] Embodiment 24. The aspiration system of embodiment 18, wherein the plurality of segments comprises a first segment, a second segment, a third segment, and a fourth segment.

[0181] Embodiment 25. The aspiration system of embodiment 24, wherein the first segment has a first shore hardness, the second segment has a second shore hardness, the third segment has a third shore hardness: and the fourth segment has a fourth shore hardness.

[0182] Embodiment 26. The aspiration system of embodiment 25, wherein the first shore hardness is about 55D, the second shore hardness is about 25D or 35D, the third shore hardness is about 73A, and the fourth shore hardness is about 40A.

[0183] Embodiment 27. The aspiration system of embodiment 16, wherein the aspiration catheter comprises a handle at a proximal end of the shaft.

[0184] Embodiment 28. The aspiration system of embodiment 27, wherein the handle comprises a hemostasis valve.

[0185] Embodiment 29. The aspiration system of embodiment 28, wherein the hemostasis valve comprises first and second cam frames.

[0186] Embodiment 30. The aspiration system of embodiment 29, wherein the hemostasis valve further comprises a flexible tube extending between the first and second cam frames, the flexible tube having a lumen extending therethrough.

[0187] Embodiment 31. The aspiration system of embodiment 30, wherein the first and second cam frames are connected to first and second buttons on the handle, wherein pressing the first and second buttons is configured to cause the first and second cam frames to rotate in opposite directions relative to one another.

[0188] Embodiment 32. The aspiration system of embodiment 31, wherein pressing the first and second buttons to rotate the first and second cam frames is configured to untwist the flexible tube, thereby opening the lumen therein.

[0189] Embodiment 33. The aspiration system of embodiment 32, wherein at least one of the first and second buttons is biased to an unpressed position.

[0190] Embodiment 34. The aspiration system of embodiment 33, wherein movement of the first and second buttons to the unpressed positions is configured to cause the first and second cam frames to rotate to twist the flexible tube in opposite directions to close the lumen therein.

[0191] Embodiment 35. The aspiration system of embodiment 28, wherein the hemostasis valve comprises first and second valve frames, each with an outwardly facing set of gear teeth.

[0192] Embodiment 36. The aspiration system of embodiment 35, wherein the hemostasis valve further comprises a flexible tube extending between the first and second valve frames, the flexible tube have a lumen extending therethrough.

[0193] Embodiment 37. The aspiration system of embodiment 36, wherein the first and second valve frames are connected to first and second buttons on the handle via one or more racks with linear gear teeth thereon, wherein pressing the first and second buttonsis configured to cause the first and second valve frames to rotate in opposite directions relative to one another.

[0194] Embodiment 38. The aspiration system of embodiment 37, wherein pressing the first and second buttons to rotate the first and second valve frames is configured to untwist the flexible tube, thereby opening the lumen therein.

[0195] Embodiment 39. The aspiration system of embodiment 38, wherein at least one of the first and second buttons is biased to an unpressed position.

[0196] Embodiment 40. The aspiration system of embodiment 39, wherein movement of the first and second buttons to the unpressed positions is configured to cause the first and second valve frames to rotate to twist the flexible tube in opposite directions to close the lumen therein.

[0197] Embodiment 41. The aspiration system of any of embodiments 38-40, wherein the hemostasis valve comprises a plurality of valve plates and a flexible tube, each of the valve plates having a notch therein configured to extend at least partially around the flexible tube.

[0198] Embodiment 42. The aspiration system of embodiment 41, wherein the hemostasis valve further comprises a plurality of pivot plates.

[0199] Embodiment 43. The aspiration system of embodiment 42, wherein the plurality of pivot plates are configured to rotate or pivot, wherein rotation of the plurality of pivot plates is configured to move the plurality of valve plates closer together or further apart.

[0200] Embodiment 44. The aspiration system of embodiment 43, wherein movement of the plurality of valve plates closer together is configured to close a lumen in the flexible tube and movement of the plurality of valve plates further apart is configured to open the lumen in the flexible tube.

[0201] Embodiment 45. The aspiration system of embodiment 28, wherein the hemostasis valve comprises first and second jaws and a flexible tube, each of the first and second jaws having a notch therein that is configured to extend at least partially around the flexible tube.

[0202] Embodiment 46. The aspiration system of embodiment 45, wherein each of the first and second jaws is pivotally connected at an end thereof, such that the first and second jaws are configured to pivot closer to and further away from the flexible tube.

[0203] Embodiment 47. The aspiration system of embodiment 46, wherein each of the first and second jaws comprises a cam surface.

[0204] Embodiment 48. The aspiration system of embodiment 47, wherein the cam surfaces on the first and second jaws engage with a button on the handle, wherein movement of the button in and out of the handle is configured to cause the first and second jaws to spread apart from one another or move closer together.

[0205] Embodiment 49. The aspiration system of embodiment 48, wherein the button and the pivots are disposed on opposite sides of the flexible tube.

[0206] Embodiment 50. The aspiration system of embodiment 48, wherein the button and the pivots are disposed on a same side of the flexible tube.

[0207] Embodiment 51. The aspiration system of any of embodiments 48-50, wherein the button, first and second jaws, and pivots are arranged in a common plane.

[0208] Embodiment 52. The aspiration system of any of embodiments 48-51, where the button and cam surfaces are arranged in a common plane and the first and second jaws each having a wing, the wings and the pivots being arranged is a common plane that is different from that of the cam surfaces and button.

[0209] Embodiment 53. The aspiration system of embodiment 28, wherein the hemostasis valve comprises a plurality of valve plates and a flexible tube, each of the valve plates having a notch that extends at least partially around the flexible tube.

[0210] Embodiment 54. The aspiration system of embodiment 53, wherein the hemostasis valve further comprises a cam plate that is configured to be rotated.

[0211] Embodiment 55. The aspiration system of embodiment 54, wherein the cam plate comprises a plurality of cam slots and the plurality of valve plates comprise a plurality of cam followers that are configured to move through the plurality of cam slots.

[0212] Embodiment 56. The aspiration system of embodiment 55, wherein the rotation of the cam plate is configured to cause the cam followers to move through the cam slots, which in turn is configured to cause the plurality of valve plates to move closer together or further apart to close or open a lumen in the flexible tube.

[0213] Embodiment 57. The aspiration system of embodiment 56, wherein each of the plurality of valve plates is configured to move substantially linearly.

[0214] Embodiment 58. The aspiration system of embodiment 57, wherein each of the plurality of valve plates is configured to rotate about a pivot.

[0215] Embodiment 59. The aspiration system of embodiment 58, wherein each of the valve plates in connected to adjacent valve plates with links.

[0216] Embodiment 60. The aspiration system of embodiment 59, wherein each of the valve plates in rotatable about a pivot to move the notches closer together or further apart to close or open a lumen in the flexible tube.

[0217] Embodiment 6E The aspiration system of embodiment 59 or 60, wherein at least one of the valve plates is connected to a button on a housing of the handle, wherein pressing the button is configured to cause the valve plates to rotate to open the lumen.

[0218] Embodiment 62. The aspiration system of embodiments 16-61. wherein the aspiration catheter comprises an inflatable structure at a distal end thereof.

[0219] Embodiment 63. The aspiration system of embodiment 62, wherein the inflatable structure comprises a balloon.

[0220] Embodiment 64. The aspiration system of embodiment 63, wherein the balloon is configured to be inflated via one or more inflation lumens within the aspiration catheter.

[0221] Embodiment 65. The aspiration system of embodiment 63 or 64, wherein, when inflated, the balloon is configured to extend distally beyond a distal end of the aspiration catheter.

[0222] Embodiment 66. The aspiration system of embodiment 65, wherein, when inflated, the balloon comprises a rounded distal region.

[0223] Embodiment 67. The aspiration system of embodiment 66, wherein the rounded distal region of the balloon forms a funnel or conical shape that tapered towards an open end of the aspiration catheter.

[0224] Embodiment 68. The aspiration system of any of embodiments 16-67, wherein the connection feature of the dilator comprises an inflatable structure.

[0225] Embodiment 69. The aspiration system of embodiment 68, wherein the inflatable structure is disposed on our outer surface of the dilator shaft.

[0226] Embodiment 70. The aspiration system of embodiment 69, wherein the inflatable structure is disposed adjacent to a distal end of the dilator shaft.

[0227] Embodiment 71. The aspiration system of any of embodiments 68-70, wherein the dilator further comprises an inflation lumen in communication with the inflatable structure.

[0228] Embodiment 72. The aspiration system of embodiment 71, wherein the inflation lumen extends through a jacket of the dilator.

[0229] Embodiment 73. The aspiration system of embodiment 71 or 72, wherein the inflation lumen is disposed within the guidewire lumen.

[0230] Embodiment 74. The aspiration system of any of embodiments 68-73, wherein the inflatable structure comprises a balloon.

[0231] Embodiment 75. The aspiration system of any of embodiments 68-74, wherein the dilator shaft comprises a recess in an outer surface thereof.

[0232] Embodiment 76. The aspiration system of embodiment 75, wherein the inflatable structure is disposed within the recess when in an uninflated configuration and extends from the recess in an inflated configuration.

[0233] Embodiment 77. A catheter system comprising: a catheter having a proximal end, a distal end, and a lumen extending therethrough between the proximal and distal ends; and a handle attached to the proximal end of the catheter, the handle comprising: a hemostasis valve, the hemostasis valve comprising: a shaft having a lumen extending therethrough; a mount having a lumen therethrough; and a valve conduit having a first end attached to the shaft, a second end attached to the lumen, and a lumen extending therethrough; a hemostasis valve input configured to move between an extended position and a pressed position; and a gear system connecting the hemostasis valve input to the hemostasis valve such that movement of the hemostasis valve input between the extended position and the pressed position causes the shaft to rotate to open or close the hemostasis valve.

[0234] Embodiment 78. The catheter system of embodiment 77, wherein the gear system comprises a pinion gear with teeth configured to engage recesses on the hemostasis valve input.

[0235] Embodiment 79. The catheter system of embodiment 78, wherein the gear system comprises a beveled gear associated with the shaft.

[0236] Embodiment 80. The catheter system of embodiment 79, wherein the gear system comprises another beveled gear having teeth that are configured to engage with teeth of the beveled gear.

[0237] Embodiment 81. The catheter system of embodiment 80, wherein the another beveled gear and the pinion gear are part of a compound gear.

[0238] Embodiment 82. The catheter system of embodiment 80 or 81. wherein the gear system comprises a reduction gear, the reduction gear and the pinion gear being linked together such that they rotate together.

[0239] Embodiment 83. The catheter system of embodiment 82. wherein the another beveled gear is configured to engage the beveled gear and the reduction gear.

[0240] Embodiment 84. The catheter system of any of embodiments 77-83, wherein the hemostasis valve input comprises a button that extend proximally from the handle.

[0241] Embodiment 85. The catheter system of embodiment 84, wherein the hemostasis valve input and the hemostasis valve form an acute angle therebetween.

[0242] Embodiment 86. The catheter system of embodiment 84, wherein the hemostasis valve input and the hemostasis valve are generally parallel to one another.

[0243] Embodiment 87. A catheter system comprising: a catheter having a proximal end, a distal end, and a lumen extending therethrough between the proximal and distal ends; and a handle attached to the proximal end of the catheter, the handle comprising: a hemostasis valve, the hemostasis valve comprising: a shaft having a lumen extending therethrough; a mount having a lumen therethrough; and a valve conduit having a first end attached to the shaft, a second end attached to the lumen, and a lumen extending therethrough; a hemostasis valve input configured to move along a portion of a length of the handle; a pulley system disposed within the handle and comprising a plurality of pulleys; and a cable connected to the hemostasis valve input, extending over the plurality of pulleys, and being connected to the shaft, wherein the cable and pulley system are configured to convert linear movement of the hemostasis valve input into rotational movement of the shaft to open and close the hemostasis valve.

[0244] Embodiment 88. The catheter system of embodiment 87, wherein the plurality of pulleys comprises a first pulley, a second pulley, and a third pulley.

[0245] Embodiment 89. The catheter system of embodiment 88, wherein the first pulley is rotatable about a first axis and the second and third pulleys are rotatable about one or more other axes.

[0246] Embodiment 90. The catheter system of embodiment 89, wherein the one or more other axes are perpendicular to the first axis.

[0247] Embodiment 91. A catheter system comprising: a catheter having a proximal end, a distal end, and a lumen extending therethrough between the proximal and distal ends; and a handle attached to the proximal end of the catheter, the handle comprising: a hemostasis valve, the hemostasis valve comprising: a shaft having a lumen extending therethrough, the shaft being mounted in the handle such that the shaft can rotate about a longitudinal axis of the shaft; a mount having a lumen therethrough; and a valve conduit having a first end attached to the shaft, a second end attached to the lumen, and a lumen extending therethrough, wherein rotation of the shaft is configured to open or close the lumen in the valve conduit; a second shaft mounted in the handle such that the second shaftcan rotate about a longitudinal axis of the second shaft; a hemostasis valve input comprising an engagement portion and first and second zipper columns, the first zipper column being connected between the engagement portion and the shaft, the second zipper column being connected between the engagement portion and the second shaft, the first and second zipper columns being configured to w rap around the shaft and the second shaft, respectively, when an external force is applied to the engagement portion.

[0248] Embodiment 92. The catheter system of embodiment 91, wherein the shaft and the second shaft are configured to rotate when an external force is applied to the engagement portion.

[0249] Embodiment 93. The catheter system of embodiment 91 or 92, wherein the first zipper columns comprises teeth.

[0250] Embodiment 94. The catheter system of embodiment 93, wherein the second zipper column comprises teeth that are configured to mate with the teeth of the first zipper column.

[0251] Embodiment 95. The catheter system of any of embodiments 91-94, wherein first zipper column is configured to convert linear movement of the engagement portion into rotational movement of the shaft to open and close the hemostasis valve.

[0252] The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

CLAIMS1. A catheter system comprising: a catheter having a proximal end, a distal end, and a lumen extending therethrough between the proximal and distal ends; and a handle attached to the proximal end of the catheter, the handle comprising a hemostasis valve, the hemostasis valve comprising: a shaft having a lumen extending therethrough; a mount having a lumen therethrough; and a valve conduit having a first end attached to the shaft, a second end attached to the lumen, and a lumen extending therethrough. wherein the shaft is rotatable relative to the mount between a first position and a second position, wherein the lumen in the valve conduit is open when the shaft is in the first position and closed when the shaft is in the second position.

2. The catheter system of claim 1, wherein the mount is disposed in a fixed position within the handle.

3. The catheter system of any of claims 1 -2, wherein rotation of the shaft to the second position causes the first end of the valve conduit to rotate relative to the second end of the valve conduit, thereby twisting the valve conduit and closing the lumen extending therethrough.

4. The catheter system of any of claims 1 -3, further comprising a hemostasis valve input that is configured to move the hemostasis valve between opened and closed configurations.

5. The catheter system of claim 4, wherein the hemostasis valve input comprises a button that is selectively movable between an extended position and a pressed position.

6. The catheter system of claim 5, wherein the button is operationally connected to the shaft such that movement of the button and the shaft are linked together.

7. The catheter system of claim 6, wherein the button comprises a plurality of recesses and the shaft comprises a plurality of gear teeth that are configured to engage the plurality of recesses.

8. The catheter system of claim 6, wherein the button and the shaft are connected together by a cable, wherein the cable extends around at least a first portion of a circumference of the shaft when the button is in the extended position, and wherein thecable extends around at least a second, smaller portion of the circumference of the shaft when the button is in the pressed position.

9. The catheter system of any of claims 1-8, wherein the hemostasis valve further comprises a frame.

10. The catheter system of claim 9, wherein the frame comprises a first recess configured to receive the shaft at least partially therein, and a second recess configured to receive the mount at least partially therein.

11. The catheter system of claim 10, wherein the frame further comprises a slot therein, the slot being configured to have the valve conduit inserted therethrough during assembly of the hemostasis valve.

12. The catheter system of any of claims 9-11, wherein the frame comprises one or more stops configured to limit rotation of the shaft and prevent rotation of the mount.

13. A valve comprising: a frame; a shaft having a lumen extending therethrough, the shaft being rotatably associated with the frame; a mount having a lumen therethrough, the mount being associated with the frame in a fixed position relative to the frame; and a valve conduit having a first end attached to the shaft, a second end attached to the lumen, and a lumen extending therethrough, wherein the shaft is rotatable relative to the frame and the mount between a first position and a second position, wherein the lumen in the valve conduit is open when the shaft is in the first position and closed when the shaft is in the second position.

14. The valve of claim 13. further comprising a valve input that is configured to cause the shaft to rotate in order to open and close the valve conduit.

15. The valve of claim 14, wherein the valve input comprises a button that is configured to move linearly and cause the shaft to rotate about a longitudinal axis.

16. An aspiration system comprising: a dilator having a shaft with a guidewire lumen extending therethrough and a connection feature at a distal end thereof; and an aspiration catheter comprising a shaft having an aspiration lumen extending therethrough, the aspiration lumen being configured to have the dilator disposed therein and selectively connected to a distal end of the aspiration catheter.

17. The aspiration system of claim 16, wherein the dilator comprises or is configured to have a hemostasis valve connected at a proximal end thereof, the hemostasis valve being configured to control a flow of fluid into or out of the guidewire lumen in the dilator.

18. The aspiration system of claim 16 or 17, wherein the shaft of the aspiration catheter comprises a plurality' of segments.

19. The aspiration system of claim 18, wherein the plurality of segments comprises a first segment, a second segment, and a third segment.

20. The aspiration system of claim 19, wherein the first segment has a first shore hardness, the second segment has a second shore hardness, and the third segment has a third shore hardness.

21. The aspiration system of claim 20, wherein the first shore hardness is harder than the second shore hardness, and the second shore hardness is harder than the third shore hardness.

22. The aspiration system of claim 20 or 21, wherein the first shore hardness is about 72D. the second shore hardness is about 55D. and the third shore hardness is about 25D.

23. The aspiration system of any of claims 19-22, wherein the third segment is configured to bend to a radius of about 20 mm without a kink.

24. The aspiration system of claim 18, wherein the plurality' of segments comprises a first segment, a second segment, a third segment, and a fourth segment.

25. The aspiration system of claim 24, wherein the first segment has a first shore hardness, the second segment has a second shore hardness, the third segment has a third shore hardness; and the fourth segment has a fourth shore hardness.

26. The aspiration system of claim 25, wherein the first shore hardness is about 55D, the second shore hardness is about 25D or 35D. the third shore hardness is about 73A, and the fourth shore hardness is about 40A.

27. The aspiration system of claim 16, wherein the aspiration catheter comprises a handle at a proximal end of the shaft.

28. The aspiration system of claim 27, yvherein the handle comprises a hemostasis valve.

29. The aspiration system of claim 28, wherein the hemostasis valve comprises first and second cam frames.

30. The aspiration system of claim 29. wherein the hemostasis valve further comprises a flexible tube extending between the first and second cam frames, the flexible tube having a lumen extending therethrough.

31. The aspiration system of claim 30, wherein the first and second cam frames are connected to first and second buttons on the handle, wherein pressing the first and second buttons is configured to cause the first and second cam frames to rotate in opposite directions relative to one another.

32. The aspiration system of claim 31, wherein pressing the first and second buttons to rotate the first and second cam frames is configured to untwist the flexible tube, thereby opening the lumen therein.

33. The aspiration system of claim 32, wherein at least one of the first and second buttons is biased to an unpressed position.

34. The aspiration system of claim 33, wherein movement of the first and second buttons to the impressed positions is configured to cause the first and second cam frames to rotate to twist the flexible tube in opposite directions to close the lumen therein.

35. The aspiration system of claim 28, wherein the hemostasis valve comprises first and second valve frames, each with an outwardly facing set of gear teeth.

36. The aspiration system of claim 35. wherein the hemostasis valve further comprises a flexible tube extending between the first and second valve frames, the flexible tube have a lumen extending therethrough.

37. The aspiration system of claim 36, wherein the first and second valve frames are connected to first and second buttons on the handle via one or more racks with linear gear teeth thereon, wherein pressing the first and second buttons is configured to cause the first and second valve frames to rotate in opposite directions relative to one another.

38. The aspiration system of claim 37, wherein pressing the first and second buttons to rotate the first and second valve frames is configured to untwist the flexible tube, thereby opening the lumen therein.

39. The aspiration system of claim 38, wherein at least one of the first and second buttons is biased to an impressed position.

40. The aspiration system of claim 39, wherein movement of the first and second buttons to the impressed positions is configured to cause the first and second valve frames to rotate to twist the flexible tube in opposite directions to close the lumen therein.

41. The aspiration system of any of claims 38-40, wherein the hemostasis valve comprises a plurality of valve plates and a flexible tube, each of the valve plates having a notch therein configured to extend at least partially around the flexible tube.

42. The aspiration system of claim 41. wherein the hemostasis valve further comprises a plurality of pivot plates.

43. The aspiration system of claim 42, wherein the plurality of pivot plates are configured to rotate or pivot, wherein rotation of the plurality of pivot plates is configured to move the plurality of valve plates closer together or further apart.

44. The aspiration system of claim 43, wherein movement of the plurality of valve plates closer together is configured to close a lumen in the flexible tube and movement of the plurality of valve plates further apart is configured to open the lumen in the flexible tube.

45. The aspiration system of claim 28, wherein the hemostasis valve comprises first and second jaws and a flexible tube, each of the first and second jaws having a notch therein that is configured to extend at least partially around the flexible tube.

46. The aspiration system of claim 45. wherein each of the first and second jaws is pivotally connected at an end thereof, such that the first and second jaws are configured to pivot closer to and further away from the flexible tube.

47. The aspiration system of claim 46, wherein each of the first and second jaws comprises a cam surface.

48. The aspiration system of claim 47, wherein the cam surfaces on the first and second jaws engage with a button on the handle, wherein movement of the button in and out of the handle is configured to cause the first and second jaws to spread apart from one another or move closer together.

49. The aspiration system of claim 48, wherein the button and the pivots are disposed on opposite sides of the flexible tube.

50. The aspiration system of claim 48, wherein the button and the pivots are disposed on a same side of the flexible tube.

51. The aspiration system of any of claims 48-50. wherein the button, first and second jaws, and pivots are arranged in a common plane.

52. The aspiration system of any of claims 48-51, where the button and cam surfaces are arranged in a common plane and the first and second jaws each having a wing, the wings and the pivots being arranged is a common plane that is different from that of the cam surfaces and button.

53. The aspiration system of claim 28, wherein the hemostasis valve comprises a plurality of valve plates and a flexible tube, each of the valve plates having a notch that extends at least partially around the flexible tube.

54. The aspiration system of claim 53. wherein the hemostasis valve further comprises a cam plate that is configured to be rotated.

55. The aspiration system of claim 54, wherein the cam plate comprises a plurality' of cam slots and the plurality of valve plates comprise a plurality’ of cam followers that are configured to move through the plurality of cam slots.

56. The aspiration system of claim 55, yvherein the rotation of the cam plate is configured to cause the cam followers to move through the cam slots, which in turn is configured to cause the plurality of valve plates to move closer together or further apart to close or open a lumen in the flexible tube.

57. The aspiration system of claim 56, wherein each of the plurality of valve plates is configured to move substantially linearly.

58. The aspiration system of claim 57, yvherein each of the plurality of valve plates is configured to rotate about a pivot.

59. The aspiration system of claim 58, wherein each of the valve plates in connected to adjacent valve plates yvith links.

60. The aspiration system of claim 59, wherein each of the valve plates in rotatable about a pivot to move the notches closer together or further apart to close or open a lumen in the flexible tube.

61. The aspiration system of claim 59 or 60, yvherein at least one of the valve plates is connected to a button on a housing of the handle, yvherein pressing the button is configured to cause the valve plates to rotate to open the lumen.

62. The aspiration system of claims 16-61, wherein the aspiration catheter comprises an inflatable structure at a distal end thereof.

63. The aspiration system of claim 62, yvherein the inflatable structure comprises a balloon.

64. The aspiration system of claim 63, wherein the balloon is configured to be inflated via one or more inflation lumens within the aspiration catheter.

65. The aspiration system of claim 63 or 64, wherein, when inflated, the balloon is configured to extend distally beyond a distal end of the aspiration catheter.

66. The aspiration system of claim 65, wherein, yvhen inflated, the balloon comprises a rounded distal region.

67. The aspiration system of claim 66, wherein the rounded distal region of the balloon forms a funnel or conical shape that tapered towards an open end of the aspiration catheter.

68. The aspiration system of any of claims 16-67, wherein the connection feature of the dilator comprises an inflatable structure.

69. The aspiration system of claim 68, wherein the inflatable structure is disposed on our outer surface of the dilator shaft.

70. The aspiration system of claim 69, wherein the inflatable structure is disposed adjacent to a distal end of the dilator shaft.

71. The aspiration system of any of claims 68-70, wherein the dilator further comprises an inflation lumen in communication with the inflatable structure.

72. The aspiration system of claim 71, wherein the inflation lumen extends through a jacket of the dilator.

73. The aspiration system of claim 71 or 72, wherein the inflation lumen is disposed within the guidewire lumen.

74. The aspiration system of any of claims 68-73, wherein the inflatable structure comprises a balloon.

75. The aspiration system of any of claims 68-74, wherein the dilator shaft comprises a recess in an outer surface thereof.

76. The aspiration system of claim 75, wherein the inflatable structure is disposed within the recess when in an unmflated configuration and extends from the recess in an inflated configuration.

77. A catheter system comprising: a catheter having a proximal end, a distal end, and a lumen extending therethrough between the proximal and distal ends: and a handle attached to the proximal end of the catheter, the handle comprising: a hemostasis valve, the hemostasis valve comprising: a shaft having a lumen extending therethrough; a mount having a lumen therethrough; and a valve conduit having a first end attached to the shaft, a second end attached to the lumen, and a lumen extending therethrough; a hemostasis valve input configured to move between an extended position and a pressed position; and a gear system connecting the hemostasis valve input to the hemostasis valve such that movement of the hemostasis valve input between the extended position and the pressed position causes the shaft to rotate to open or close the hemostasis valve.

78. The catheter system of claim 77, wherein the gear system comprises a pinion gear with teeth configured to engage recesses on the hemostasis valve input.

79. The catheter system of claim 78, wherein the gear system comprises a beveled gear associated with the shaft.

80. The catheter system of claim 79, wherein the gear system comprises another beveled gear having teeth that are configured to engage with teeth of the beveled gear.

81. The catheter system of claim 80, wherein the another beveled gear and the pinion gear are part of a compound gear.

82. The catheter system of claim 80, wherein the gear system comprises a reduction gear, the reduction gear and the pinion gear being linked together such that they rotate together.

83. The catheter system of claim 82, wherein the another beveled gear is configured to engage the beveled gear and the reduction gear.

84. The catheter system of any of claims 77-83, wherein the hemostasis valve input comprises a button that extend proximally from the handle.

85. The catheter system of claim 84, wherein the hemostasis valve input and the hemostasis valve form an acute angle therebetween.

86. The catheter system of claim 84, wherein the hemostasis valve input and the hemostasis valve are generally parallel to one another.

87. A catheter system comprising: a catheter having a proximal end, a distal end, and a lumen extending therethrough between the proximal and distal ends: and a handle attached to the proximal end of the catheter, the handle comprising: a hemostasis valve, the hemostasis valve comprising: a shaft having a lumen extending therethrough; a mount having a lumen therethrough; and a valve conduit having a first end attached to the shaft, a second end attached to the lumen, and a lumen extending therethrough; a hemostasis valve input configured to move along a portion of a length of the handle; a pulley system disposed within the handle and comprising a plurality of pulleys; and a cable connected to the hemostasis valve input, extending over the plurality of pulleys, and being connected to the shaft,wherein the cable and pulley system are configured to convert linear movement of the hemostasis valve input into rotational movement of the shaft to open and close the hemostasis valve.

88. The catheter system of claim 87, wherein the plurality of pulleys comprises a first pulley, a second pulley, and a third pulley.

89. The catheter system of claim 88, wherein the first pulley is rotatable about a first axis and the second and third pulleys are rotatable about one or more other axes.

90. The catheter system of claim 89, wherein the one or more other axes are perpendicular to the first axis.

91. A catheter system comprising: a catheter having a proximal end, a distal end. and a lumen extending therethrough between the proximal and distal ends; and a handle attached to the proximal end of the catheter, the handle comprising: a hemostasis valve, the hemostasis valve comprising: a shaft having a lumen extending therethrough, the shaft being mounted in the handle such that the shaft can rotate about a longitudinal axis of the shaft; a mount having a lumen therethrough; and a valve conduit having a first end attached to the shaft, a second end attached to the lumen, and a lumen extending therethrough, wherein rotation of the shaft is configured to open or close the lumen in the valve conduit; a second shaft mounted in the handle such that the second shaft can rotate about a longitudinal axis of the second shaft; a hemostasis valve input comprising an engagement portion and first and second zipper columns, the first zipper column being connected between the engagement portion and the shaft, the second zipper column being connected between the engagement portion and the second shaft, the first and second zipper columns being configured to wrap around the shaft and the second shaft, respectively, when an external force is applied to the engagement portion.

92. The catheter system of claim 91, wherein the shaft and the second shaft are configured to rotate when an external force is applied to the engagement portion.

93. The catheter system of claim 91 or 92, wherein the first zipper columns comprises teeth.

94. The catheter system of claim 93, wherein the second zipper column comprises teeth that are configured to mate with the teeth of the first zipper column.

95. The catheter system of any of claims 91-94, wherein first zipper column is configured to convert linear movement of the engagement portion into rotational movement of the shaft to open and close the hemostasis valve.

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