Suction control valve

Abstract

To provide a system for suction control.SOLUTION: A system comprises a control valve which is in communication with a hemostatic valve. The control valve includes a section of a compressive tube haing an opening which is adjustable between a first dimension which is sized to limit a flow of blood sucked from a catheter to a first flow rate, and a second dimension which is sized to limit the flow of blood sucked from the catheter to a second flow rate. A compressive element is of spring type or is connected to a trigger using spring force. Thus, when the trigger is released, the compressive element moves as a result of the spring force and expands in the opening of the housing part, thereby moving the trigger toward an initial position and narrowing the opening in the compressive tube.SELECTED DRAWING: Figure 6B

Description

[Technical field]

[0001] The present invention relates generally to intravascular medical procedures, and more specifically to regulating the amount of blood flow aspirated during a thrombectomy procedure. [Background technology]

[0002] During endovascular medical procedures, it may be beneficial to slow or reverse blood flow at a treatment site within a patient. For example, during a thrombectomy procedure, a physician may utilize a syringe or vacuum pump to provide reverse blood flow to assist in the dislodging and retrieving of clots or thrombi in combination with a stentriever, or for direct aspiration into an intermediate or access catheter. The syringe or vacuum pump may be connected to the proximal end of the intermediate or guide catheter (e.g., a balloon guide catheter), and a vacuum may communicate with the distal tip of the catheter through the lumen of the catheter. The syringe and vacuum pump are typically connected to the side arm of a "rotating hemostatic valve" that is attached to the proximal end of the intermediate or guide catheter. "Rotating" refers to a luer connection that can be threaded onto the proximal end of the catheter and freely rotated to facilitate attachment, while the hemostatic feature facilitates the introduction of other catheters and accessory devices through the intermediate or guide catheter while minimizing back bleed and blood loss. Hemostatic valves typically contain a gasket that can be fully opened to introduce a device or can be tightened to prevent any blood loss. The gasket can also be tightened to grip a guidewire or microcatheter positioned inside the intermediate or guide catheter. Known hemostatic valves typically include an inlet passage for receiving an accessory device or catheter in a hemostatically sealed state, and a side port that can be used to connect injectables such as saline flush, contrast media, or to which an aspiration syringe or vacuum pump can be attached.

[0003] The known hemostatic value may also include a passageway through which a guidewire, microcatheter, intermediate catheter, device shaft, or such elongate member may pass. The passageway may include a gasket for hemostatically sealing the periphery of the inner elongate member to minimize blood loss and, if necessary, to hold the inner elongate member in position.

[0004] During thrombectomy, a syringe or vacuum pump may provide suction through the lumen of the intermediate or guide catheter to generate backflow at the clot. When a vacuum pump is used, the vacuum pump is typically set to maximum to apply full vacuum / suction when the clot is being retrieved. Similarly, when a vacuum lock syringe is used, full vacuum is typically applied for as long as possible until the syringe is full to provide maximum backflow.

[0005] In some procedures, physicians may wish to vary the suction speed during the procedure to suit the particular aspects of the clinical case. For example, during thrombectomy, physicians may prefer to suction slowly for initial clot release, then increase the suction force as the clot approaches the catheter, and then further increase the suction force to a maximum as the clot is drawn into the catheter. Increasing suction during clot retrieval can reduce the possibility of vessel collapse due to negative pressure in the vasculature, and when performed with a syringe, can more effectively utilize the fixed volume of the syringe compared to a constantly applied vacuum. This technique requires simultaneous manipulation of the syringe or pump, retraction of the clot removal device, and stabilization of the catheter, which can be extremely difficult with conventional systems. Summary of the Invention [Problem to be solved by the invention]

[0006] Thus, there is a need for improved methods, devices, and systems for controlling aspiration during thrombectomy. Similarly, control of aspiration flow rate is potentially beneficial in other intravascular or medical procedures in which aspiration pumps or aspiration syringes are used. [Means for solving the problem]

[0007] It is an object of the present invention to provide a system, device, and method that meets the above-mentioned needs. In general, it is an object of the present invention to provide an aspiration control device having an aspiration control valve controllable by a switch, button, slider, trigger, grip, lever, rotating wheel, rotary valve, handle, or other interface that is conveniently positioned and configured to be operated while simultaneously stabilizing the hemostasis valve and catheter with one hand and / or retracting the elongate member with the other hand. The aspiration control device may be integrated into the hemostasis valve, integrated into the wire grip device, and / or attached to an inlet, outlet, hose, pump, or syringe in series with the aspiration flow path. A system for aspirating blood flow during an intravascular procedure may include a combination of one or more aspiration control devices, one or more hemostasis valves, one or more wire grip devices, and / or one or more vacuum sources to provide and / or regulate vacuum to one or more catheters.

[0008] An exemplary system may include a hemostasis valve, a control valve, and a control interface. The hemostasis valve may have an inlet for receiving the catheter. The control valve may be in communication with the hemostasis valve and may have an opening resizable from a first dimension to a second dimension, the first dimension sized to restrict the flow of aspirated blood from the catheter to a first flow rate and the second dimension sized to restrict the flow of aspirated blood from the catheter to a second flow rate. The control interface may be in communication with the control valve, and the control interface may be movable to move the opening of the control valve from the first dimension to the second dimension.

[0009] The hemostasis valve may further include a side port. The control valve may be positioned proximate to the side port. The control valve may be positioned to provide a flow path for the flow of aspirated blood, the flow path extending from the catheter, through the control valve, to the side port. The control valve and the control interface may be integrated with the hemostasis valve within a common housing.

[0010] The control interface may be positioned to allow a user to select one of the first or second flow rates with one hand while stabilizing the catheter with the same hand. The control interface may be a button configured to select at least one of the first or second flow rates based at least in part on a force applied to the control interface. The opening of the control valve may be movable over a continuum between the first and second dimensions such that the flow of aspirated blood is controllable over a continuum of flow rates between the first and second flow rates. The control interface may be movable through a continuum of positions to move the opening of the control valve over a continuum of dimensions. The control interface may be spring loaded, set to a default open or closed position, or ratcheted to be set to any interim position between fully open and fully closed.

[0011] The hemostatic valve may further include an outlet sized to pass through the inner elongated member, a seal disposed near the outlet, a locking actuator displaceable to open, semi-open, or close the seal, and a hemostatic indicator movable to provide a visual indication of the position of the locking actuator. The inner elongated member may be disposed within a lumen of the catheter. The locking actuator may be displaceable from a first position, a second position, and a third position, each position corresponding to an open, semi-open, or closed state of the seal, respectively. The hemostatic indicator may be movable to indicate which position the locking actuator is currently in. When the locking actuator is in the semi-open position, the inner elongated member may be retracted or moved within the catheter while the seal provides a sufficient seal to prevent air ingress when a vacuum is applied to the side port during aspiration. During a thrombectomy procedure, the inner elongated member may be a microcatheter and the stentriever may be retracted to retrieve the clot within the catheter when the catheter is under full vacuum with no air leakage through the locking actuator seal.

[0012] An exemplary device may include a distal port, a proximal port, a first side port, a first flow path, a control valve, and a control interface. The distal port may be sized to receive a catheter. The proximal port may be sized to allow passage of an inner elongate member, the inner elongate member being disposed within a lumen of the catheter. The first flow path may extend from the lumen of the catheter to the first side port. The control valve may be in communication with the lumen of the catheter and the first side port, the control valve may be movable to control blood flow through the first flow path. The control interface may be in communication with the control valve, the control interface may be movable between at least two positions, the at least two positions corresponding to at least two flow rates of blood flow through the first flow path.

[0013] The control interface may have a sliding button positioned to allow the user to simultaneously select one of two or more positions with one hand while also stabilizing the catheter with the other hand.

[0014] The control interface may have a push button that can be pressed with force to simultaneously stabilize the catheter with one hand while moving the push button between two or more positions.

[0015] The device may further include a second side port and a second flow path. The second flow path may extend from the second side port to the first side port. The control valve may be in communication with the second side port and the first side port, and the control valve may be movable to control blood flow through the second flow path.

[0016] An exemplary method for aspirating blood flow may include some or all of the following steps and variations thereof, the steps being listed in any order: A hemostasis valve may be provided having a distal port and a side port; A suction control device may be provided having a control valve and a control interface; The suction control device may be positioned proximate the side port; The hemostasis valve and the suction control valve may be disposed within a common housing.

[0017] A flow path may be provided from a lumen of the catheter positioned within the distal port to the side port. A control valve of the suction control device may be positioned within the flow path. A flexible tube having an opening may be positioned within the flow path. A housing may be provided having an opening. The flexible tube may be positioned within the housing. A compression element may be provided in communication with the control interface. The compression element may be positioned to engage the flexible tube. The compression element may be positioned within the opening in the housing. The compression element may be moved to resize the opening in the flexible tube by manipulating the control interface.

[0018] A catheter may be provided, and the catheter may be positioned within the distal port. A vacuum source may be provided. A vacuum may be provided to the flow path with the vacuum source. A control interface may be operated to control a flow rate through the flow path. A force may be applied to the control interface to operate the control interface, and the control interface may be moved from an initial position by applying a force to the control interface. The control interface may be simultaneously operated with a first hand while the catheter is stabilized with the other hand. The control interface may be released. The control interface may be returned to the initial position. [Brief description of the drawings]

[0019] The above and further aspects of the present invention will be further discussed with reference to the following description in conjunction with the accompanying drawings, in which like numerals indicate like structural elements and features in the various drawings. The drawings are not necessarily to scale, emphasis instead being placed on illustrating the principles of the invention. The figures depict one or more implementations of a device of the present invention, by way of example only and not by way of limitation. [Figure 1] 1 is an illustration of a suction control device connected to a hemostasis valve, according to an aspect of the present invention. [Diagram 2] 1 is an illustration of a suction control device having a sliding interface integrated with a hemostasis valve, according to an aspect of the present invention. [Diagram 3] 1 is an illustration of a suction control device having a push button interface integrated into a hemostasis valve, according to an aspect of the present invention. [Figure 4] 1 is an illustration of a system including a suction control device connected to regulate suction at two hemostasis valves, according to an embodiment of the present invention. [Diagram 5] 1 is an illustration of a system including a suction control device integrated into a wire gripping device, according to an aspect of the present invention. [Figure 6A] 1 is an illustration of an aspiration control device having a trigger, a locking actuator, and a hemostasis indicator integrated into a hemostasis valve, according to an aspect of the present invention. [Figure 6B]1 is an illustration of an aspiration control device having a trigger, a locking actuator, and a hemostasis indicator integrated into a hemostasis valve, according to an aspect of the present invention. [Figure 6C] 1 is an illustration of an aspiration control device having a trigger, a locking actuator, and a hemostasis indicator integrated into a hemostasis valve, according to an aspect of the present invention. [Figure 7A] 1 is an illustration of a locking actuator, according to an aspect of the present invention. [Figure 7B] 1 is an illustration of a hemostasis indicator according to an embodiment of the present invention. [Figure 7C] 1 is an illustration of a hemostasis indicator according to an embodiment of the present invention. [Figure 7D] 1 is an illustration of a hemostasis indicator according to an embodiment of the present invention. [Figure 7E] 1 is an illustration of a hemostasis indicator according to an embodiment of the present invention. [Figure 7F] 1 is an illustration of a hemostasis indicator according to an embodiment of the present invention. [Figure 7G] 1 is an illustration of a hemostasis indicator according to an embodiment of the present invention. [Figure 7H] 1 is an illustration of a hemostasis indicator according to an embodiment of the present invention. [Figure 7I] 1 is an illustration of a hemostasis indicator according to an embodiment of the present invention. [Figure 8A] 1 is an illustration of an aspiration control device having a trigger finger grip interface integrated with a hemostasis valve, according to an aspect of the present invention. [Figure 8B] 1 is an illustration of an aspiration control device having a trigger finger grip interface integrated with a hemostasis valve, according to an aspect of the present invention. [Figure 8C] 1 is an illustration of an aspiration control device having a trigger finger grip interface integrated with a hemostasis valve, according to an aspect of the present invention. [Figure 8D] 1 is an illustration of an aspiration control device having a trigger finger grip interface integrated with a hemostasis valve, according to an aspect of the present invention. [Figure 9A]1 is an illustration of a suction control device having a two-finger grip interface integrated with a hemostasis valve, according to an embodiment of the present invention. [Figure 9B] 1 is an illustration of a suction control device having a two-finger grip interface integrated with a hemostasis valve, according to an embodiment of the present invention. [Figure 9C] 1 is an illustration of a suction control device having a two-finger grip interface integrated with a hemostasis valve, according to an embodiment of the present invention. [Figure 10A] 1 is an illustration of a suction control device having a lever interface integrated with a hemostasis valve, according to an aspect of the present invention. [Figure 10B] 1 is an illustration of a suction control device having a lever interface integrated with a hemostasis valve, according to an aspect of the present invention. [Figure 10C] 1 is an illustration of a suction control device having a lever interface integrated with a hemostasis valve, according to an aspect of the present invention. [Figure 11A] 1A-1C are illustrations of two variations of an aspiration control device having a thumb trigger interface integrated with a hemostasis valve, according to an embodiment of the present invention. [Figure 11B] 1A-1C are illustrations of two variations of an aspiration control device having a thumb trigger interface integrated with a hemostasis valve, according to an embodiment of the present invention. [Figure 11C] 1A-1C are illustrations of two variations of an aspiration control device having a thumb trigger interface integrated with a hemostasis valve, according to an embodiment of the present invention. [Figure 11D] 1A-1C are illustrations of two variations of an aspiration control device having a thumb trigger interface integrated with a hemostasis valve, according to an embodiment of the present invention. [Figure 11E] 1A-1C are illustrations of two variations of an aspiration control device having a thumb trigger interface integrated with a hemostasis valve, according to an embodiment of the present invention. [Figure 11F] 1A-1C are illustrations of two variations of an aspiration control device having a thumb trigger interface integrated with a hemostasis valve, according to an embodiment of the present invention. [Figure 12]1 is an illustration of an aspiration control device having a side grip interface integrated with a hemostasis valve, according to an aspect of the present invention. [Figure 13A] 1 is an illustration of a blood flow indicator for a suction control device, according to an aspect of the present invention. [Figure 13B] 1 is an illustration of a blood flow indicator for a suction control device, according to an aspect of the present invention. [Figure 13C] 1 is an illustration of a blood flow indicator for a suction control device, according to an aspect of the present invention. [Figure 13D] 1 is an illustration of a blood flow indicator for a suction control device, according to an aspect of the present invention. [Figure 13E] 1 is an illustration of a blood flow indicator for a suction control device, according to an aspect of the present invention. [Figure 14A] 1 is an illustration of a suction control device controlled by a push button interface integrated into a hemostasis valve, according to an aspect of the present invention. [Figure 14B] 1 is an illustration of a suction control device controlled by a push button interface integrated into a hemostasis valve, according to an aspect of the present invention. [Figure 14C] 1 is an illustration of a suction control device controlled by a push button interface integrated into a hemostasis valve, according to an aspect of the present invention. [Figure 14D] 1 is an illustration of a suction control device controlled by a push button interface integrated into a hemostasis valve, according to an aspect of the present invention. [Figure 15] 1 is an illustration of a suction control device controlled by a switch interface according to an embodiment of the present invention. [Figure 16] 1 is an illustration of a system including two suction control devices configured to regulate suction at two hemostasis valves using only one vacuum source, according to an embodiment of the present invention. [Figure 17] 1 is an illustration of an aspiration control device having an electrical actuation interface. [Figure 18] 1 is a flow diagram including steps of a method for controlling aspiration during a thrombectomy procedure, according to an embodiment of the present invention. [Figure 19] 1 is a flow diagram including steps of a method for controlling aspiration during a thrombectomy procedure, according to an embodiment of the present invention. [Figure 20] 1 is a flow diagram including steps of a method for controlling aspiration during a thrombectomy procedure, according to an embodiment of the present invention. [Figure 21] 1 is a flow diagram including steps of a method for controlling aspiration during a thrombectomy procedure, according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] Examples disclosed herein may generally include an aspiration control device or device used in conjunction with a hemostasis valve to allow a physician to more easily vary the flow rate of blood aspirated during an endovascular procedure compared to some conventional systems. The aspiration control device may include a control valve in a flow path of the blood to be aspirated and an interface for moving the control valve to adjust the flow rate through the flow path. Controlling the flow rate at the control valve may control the reverse blood flow at the treatment site. For example, the rate of reverse blood flow around a clot may be changed during a thrombectomy procedure by manipulating the aspiration control device.

[0021] The suction control device may be positioned in various locations and have various configurations of the control interface to achieve greater ease of use compared to conventional systems. For example, the suction control device may be a standalone assembly that is connectable to a side port of the hemostasis valve, the suction control device and the hemostasis valve may be integrated as a single assembly, or the suction control device may be integrated with a secondary device such as a wire grip device. The interface for moving the control valve may move between two or more distinct positions or over a continuum of positions. Similarly, the control valve may be movable between two or more distinct positions or over a continuum of positions in response to the positioning of the interface. The regulated flow rate through the control valve may be adjusted by the movement of the control valve. For example, the interface may include a mechanical interface such as a slider, push button, switch, wheel, trigger, grip, lever, rotary valve, handle, etc., which allows the physician to simultaneously stabilize the guide catheter or sheath with only one hand while regulating the flow rate, leaving the physician's second hand free for other activities such as withdrawing the stentriever and microcatheter. The interface may be designed to function similarly to valves already known to physicians, such as rotary valves, to provide a more intuitive interface. In some examples, the aspiration control device may additionally include an electrical actuator that can be programmed to provide a particular waveform or aspiration flow pattern.

[0022] Some exemplary systems having a purely mechanical suction control device, and some that additionally include an electrical actuator, can be used to switch the vacuum on or off, allowing the vacuum to provide a sudden and significant pressure change in the catheter to help result in improved engagement and removal of difficult clots.

[0023] The control valve may have various orientations to regulate blood flow through it. The control valve may include a section of compressible tubing that may be compressed by manipulating the suction control device interface. The valve may be in a normally open, uncompressed state when not manipulated and may compress to restrict flow as a result of manipulation of the interface, the valve may be in a normally closed, compressed state when not manipulated and may expand to increase flow as a result of manipulation, or the valve may retain its final state of compression, possibly a partially compressed state, when not manipulated and when moved to a different retainable state as a result of manipulation. For example, a spring-loaded control valve may be designed as a normally open or normally closed valve, and a rotary valve may be designed as a state-holding valve.

[0024] The suction control device may be designed to be used with two hemostatic valves, where a first hemostatic valve provides an aspiration path for the guide catheter and a second hemostatic valve provides an aspiration path for the intermediate catheter. The suction control device may simultaneously regulate the vacuum through the guide catheter and the intermediate catheter via connection to both the first and second hemostatic valves. The advantage of this configuration is the ability to provide suction at two hemostatic valves with a single vacuum source (e.g., a single pump or syringe). The second suction control device may be used with two hemostatic valves and the first suction control device, where the second suction control device may be connected to a single vacuum source via the first suction control device. So configured, the two catheters may simultaneously receive suction from a single vacuum at different vacuum pressures.

[0025] Alternatively, or in addition, the suction control device may be designed to be integrated into a secondary device that may be used in conjunction with the hemostasis valve. For example, the suction control device may be integrated into a wire grip device, allowing the physician to use one hand to control the suction rate while simultaneously retracting the thrombus removal device and / or microcatheter, leaving the physician's second hand free for other activities such as stabilizing the guide catheter.

[0026] FIG. 1 is an illustration of an exemplary system 100 including an aspiration control device 120 and a hemostasis valve 160. FIG. 1 illustrates the aspiration control device 120 as a stand-alone device that is connectable to a side port 166 of the hemostasis valve 160 and connectable to the tubing 112 of a vacuum system. An advantage of the stand-alone aspiration control device 120 is that it can be configured to mate with a conventional hemostasis valve 160. The catheter 102 can be received by the inlet 162 of the hemostasis valve 160, and the aspiration control device 120 can be positioned in a flow path from the catheter 102, through the side port 166 of the hemostasis valve 160, through the tubing 112 and out to the vacuum system. The aspiration control device 120 can have an internal valve that can be adjusted by moving a control interface or actuator 140. The aspiration control device 120 can include a flow indicator 152 to provide a visual indication of the rate of blood flow through the aspiration control device 120. The suction control device 120 can be positioned so that a physician can adjust the flow rate through the flow path using the interface 140 while simultaneously stabilizing the guide catheter 102 and withdrawing a pull wire, shaft of a clot removal device, or other inner elongated member 108 from the outlet 164 of the hemostasis valve 160.

[0027] 2 is an illustration of an exemplary system 200 including an aspiration control device 220 integrated with a hemostatic valve 260. The integrated aspiration control device 220 and hemostatic valve 260 may be integrated into a common housing. The integrated device may have an inlet 262 with a luer connection to receive and hemostatically seal the catheter 202, an outlet 264 sized to allow passage of the inner elongate member 208 and adjustable to hemostatically seal the inner elongate member 208, a side port 266 designed to connect with a vacuum system, a control interface 240 for operating the control valve to regulate the aspirated blood flow, and a visual indicator 252 that provides an indication of the aspirated blood flow rate. The control valve may be positioned in a flow path extending from the lumen of the catheter 202 to the side port 266, and the control valve may regulate the aspirated blood flow rate through the flow path. The control interface 240 can be a slider button that is movable along a track 241, and the control valve can have an opening that is resized as the slider 240 is moved along the track 241, thereby regulating the amount of blood flow that is aspirated. The slider 240 can be spring loaded to return to a default position when not manipulated. Alternatively, the slider 340 may maintain the position to which it was most recently moved when not manipulated.

[0028] 3 is an illustration of an exemplary system 300 including an aspiration control device 320 integrated with a hemostatic valve 360. The integrated aspiration control device 320 and hemostatic valve 360 ​​may be integrated into a common housing. The integrated device may have an inlet 362 sized to receive and hemostatically seal the catheter 302, an outlet 364 sized to allow passage of the inner elongated member 308 and hemostatically seal the inner elongated member 308, a side port 366 designed to connect to a vacuum system, an aspiration control valve in communication with the side port 366, and a control interface 340 for operating the control valve to regulate aspirated blood flow. The control valve may be positioned in a flow path extending from the lumen of the catheter 302 to the side port 366, and the control valve may regulate the amount of aspirated blood flow through the flow path. The control interface 340 may be a push button movable from a fully extended state to a fully compressed state. The push button 340 may be held in an intermediate state between fully extended and fully compressed. The control valve may have an opening that is sized depending on the state of the push button, and the flow rate through the flow path may be adjusted based on the size of the opening. The control valve may be normally open, meaning that the control valve opening is a maximum size to allow a maximum flow rate when the push button 340 is fully extended, and the control valve opening contracts to restrict blood flow when the push button 340 is compressed. Alternatively, the control valve may be normally closed, meaning that the control valve opening is a minimum size to allow a minimum flow rate when the push button 340 is fully extended, and the control valve opening expands to allow more blood flow when the push button 340 is compressed.

[0029] 4 is an illustration of an exemplary system 400 including a suction control device 420 connected to regulate suction at two hemostasis valves 460, 480. The system 400 can provide suction to two catheters 402, 404 simultaneously from a single vacuum source 414, and the suction control device 420 can regulate the flow rate through both catheters 402, 404 simultaneously.

[0030] The system 400 may include a first hemostatic valve 460 integrated with the aspiration control device 420. The integrated aspiration control device 420 and hemostatic valve 460 may be integrated into a common housing. The integrated device may have an inlet 462 sized to receive and hemostatically seal the guide catheter 402, an outlet 464 sized to allow passage of and hemostatically seal the intermediate catheter 404, a first side port 466 designed to connect to a vacuum system, a second side port 468 designed to connect to a second hemostatic valve 480, an aspiration control valve in communication with the first side port 466 and the second side port 468, a control interface 440 for operating the control valve to regulate aspirated blood flow, and a visual indicator 452 providing an indication of the amount of aspirated blood flow through the control valve.

[0031] The system 400 may include a second hemostatic valve 480 having an inlet 482 positioned to receive and hemostatically seal the intermediate catheter 404, an outlet 484 sized to allow passage of an inner elongate member 408, such as a microcatheter, and to hemostatically seal the inner elongate member 408, and a side port 486. The side port 486 of the second hemostatic valve 480 may be connected to the second side port 468 of the first hemostatic valve 460 by the tubing 416.

[0032] The system 400 may include two flow paths for simultaneously providing suction to each catheter 402, 404. The two flow paths may meet within a control valve of the suction control device 420 and receive vacuum pressure from a syringe 414 or other vacuum source connected at a first side port 466 of the first hemostatic valve 460. The first flow path may extend from a lumen of the guide catheter 402 to the first side port 466 of the first hemostatic valve 460. The second flow path may extend from a lumen of the intermediate catheter 404, through a side port 486 of the second hemostatic valve 480, through the tube 416, through a second side port 468 of the first hemostatic valve 460, through the control valve of the suction control device 420, to the first side port 466 of the first hemostatic valve 460. Because the first and second flow paths merge within the control valve, the control valve can regulate a first aspirated blood flow rate through the first flow path and a second aspirated blood flow rate through the second flow path. A visual indicator 452 can indicate the aspirated blood flow rate through the control valve. The flow rate through the control valve can be the sum of the first flow rate through the first flow path and the second flow rate through the second flow path.

[0033] The control interface 440 can be a slider button that is movable along a track 441, and the control valve can have an opening that is resized as the slider 440 is moved along the track 441, thereby regulating the first and second aspirated blood flow rates. The slider 440 can be spring loaded to return to a default position when not manipulated. Alternatively, the slider 440 may maintain the position to which it was most recently moved when not manipulated.

[0034] 5 is an illustration of an exemplary system 500 including an aspiration control device 520 integrated with a wire grip device 590. The system 500 may include two hemostasis valves 560, 580. At least one of the hemostasis valves 560 may be connected to the aspiration control device 520 to receive suction from a vacuum source by the aspiration control device. The aspiration control device 520 may be positioned such that a physician may simultaneously operate the wire grip device 590 and the control interface 540 of the aspiration control device 520 with one hand while the physician's second hand may be free to perform other tasks, such as stabilizing the guide catheter 502.

[0035] The system 500 may include a first hemostatic valve 560 and a second hemostatic valve 580, each having a hemostatically sealable inlet 562, 582, a hemostatically sealable outlet 564, 584, and a side port 566, 586. The hemostatic valves 560, 580 may be conventional hemostatic valves known in the art or hemostatic valves incorporating features described herein. The first hemostatic valve 560 may receive the guide catheter 502 at the inlet 562, pass the intermediate catheter 504 through the outlet 564, and connect to the tube 516 at the side port 566. The second hemostatic valve 580 may receive the microcatheter 504 at the inlet 582, pass the stentriever 508 or other such shaft, guidewire, or inner elongate member through the outlet 584, and have a side port 586 that may be connected to a pressure flush system, such as for standard thrombectomy.

[0036] The integrated wire gripping device 590 and suction control device 520 may be integrated into a common housing. The integrated apparatus may have an inlet 592 for receiving and gripping the inner elongated member 508, an outlet for passing the inner elongated member 508, a first side port 596, a second side port 598, a control valve, and a control interface 540 for the control valve.

[0037] System 500 may include a first flow path from guide catheter 502, through a side port 566 of first hemostasis valve 560, through tubing 516, through a second port 598 of the integrated pull wire / suction control, through a control valve of suction control device 520, to a first port 596 of the integrated pull wire / suction control. Suction control device 520 may control flow through the first flow path to regulate the flow of blood aspirated through guide catheter 502.

[0038] The control interface 540 may be a slider button that is movable along a track 541, and the control valve may have an opening that is resized as the slider 540 is moved along the track 541, thereby regulating the amount of blood flow aspirated through the guide catheter 502. The slider 540 may be spring loaded to return to a default position when not manipulated. Alternatively, the slider 540 may maintain the position to which it was most recently moved when not manipulated.

[0039] 5, a physician may simultaneously control suction by manipulating the control interface 540 while withdrawing the microcatheter 504 and the thrombus removal device shaft 508 from the catheter 502. In an exemplary embodiment, the system may be configured such that the outlet 564 of the first hemostatic valve 560 is in a semi-open position allowing the microcatheter 504 to slide through the outlet 564 while preventing air leakage, the microcatheter 504 may be locked in place at the inlet of the second hemostatic valve 580 to prevent the microcatheter 504 from moving relative to the second hemostatic valve 580, the outlet 584 of the second hemostatic valve 580 may be locked around the stentriever device shaft 508 to prevent the shaft 508 from moving relative to the second hemostatic valve 580 and the microcatheter 504, and the wire gripping device 590 may be locked to the shaft 508 to prevent the shaft 508 from moving relative to the gripping device 590. So configured, the wire gripping device 590 can be moved proximally relative to the first hemostasis valve 560, thereby pulling the stentriever shaft 508, the second hemostasis valve 580, and the microcatheter 504 proximally and withdrawing the microcatheter 504 and device 508 from the guide catheter 502. The physician can use one hand to stabilize the first hemostasis valve 560 while simultaneously pulling the wire gripping device 590 and operating the control interface 540 on the wire gripping device 590 with the other hand.

[0040] Figure 6A is an illustration of an exemplary system 600 including an aspiration control device 620 having a trigger control interface 640 integrated with a hemostasis valve 660. Figures 6B and 6C are cross-sectional views of the aspiration control device 620 depicted in Figure 6A, with Figure 6B illustrating the control interface 640 in an initial position and Figure 6C illustrating the control interface 640 in a retracted position. With reference collectively to Figures 6A and 6C, the integrated aspiration control device 620 and hemostasis valve 660 may be integrated into a common housing. The integrated device may have an inlet 662 sized to receive and hemostatically seal the catheter 602, an outlet 664 sized to allow passage of the inner elongate member 608 and to hemostatically seal the inner elongate member 608, a side port 666 designed to connect to a vacuum system, a suction control valve 622 in communication with the side port 666, a trigger control interface 640 for operating the control valve 622 to regulate the flow of aspirated blood, a locking actuator 670 positioned at the outlet 664, and a hemostatic indicator 672 for indicating the status of the hemostatic seal at the outlet 664.

[0041] The control valve 622 may be positioned in a flow path extending from the lumen 603 of the guide catheter 602, through the proximal end 663 of the guide catheter 602, to the side port 666, and the control valve 622 may regulate the amount of aspirated blood flow through the flow path. The control interface 640 may be a trigger movable along a portion 644 of the housing that extends toward the side port 666. The portion 644 may define the length of travel of the trigger 640 such that when the trigger is closest to the side port 666, the trigger is in an initial, or fully extended, position, and when the trigger is closest to the body of the hemostasis valve 660, the trigger is in a final, or fully retracted, position. The trigger 640 may be spring loaded to return to the initial position when the trigger 640 is not being manipulated.

[0042] The integrated suction control / hemostasis valve device may be grasped in one hand with the thumb positioned on the body of the device near the outlet lock actuator 670, the index finger positioned on the trigger 640, and the remaining fingers positioned on the device and guide catheter 602 to stabilize the guide catheter 602. The trigger may be moved from the initial position to the retracted position by squeezing the index finger toward the thumb.

[0043] 6B and 6C, the suction control device 620 may include a control valve 622 that includes a compressible tube 624 having an opening 626 that is movable through a range of dimensions in response to being compressed or released by a compression element 642 in communication with a trigger 640. The suction control device 620 may be a normally closed device.

[0044] 6B illustrates control interface 640 in an initial position, in which compression element 642 may extend through opening 646 in housing 644 to provide maximum compression to compressible tube 624. As trigger 640 is moved from the initial position, as indicated by the larger arrow, compression element 642 may engage an edge of opening 646 in housing 644 and flex away from compressible tube 624, as indicated by the smaller arrow.

[0045] 6C illustrates the control interface 640 in a retracted position, with the compression element 642 bent to move out of an opening 646 in the housing 644 as a result of the trigger being squeezed away from the side port 666. As the compression element 642 bends away from the compressible tube 624, the opening 626 in the compressible tube 624 may widen to allow for a greater flow rate through the control valve 622.

[0046] Compression element 642 may be spring loaded or connected to trigger 640 using a spring force such that when trigger 640 is released, compression element 642 moves as a result of the spring force and expands within opening 646 in housing portion 644, thereby moving trigger 640 toward an initial position (illustrated in FIG. 6B) and narrowing opening 626 in compressible tube 624.

[0047] 7A is an illustration of an exemplary locking actuator 770 and an exemplary hemostasis indicator 772a that may be positioned at the hemostasis valve outlet 764. The locking actuator 770 may be tightened by manipulating a rotating thumb wheel or pressing a push button. The locking actuator 770 may include a gasket or other seal that may be tightened onto a catheter, pull wire, or other elongated member extending through the hemostasis valve outlet 764. The locking actuator 770 may allow retraction of the elongated member from the outlet 764 while sealing the elongated member against air ingress during aspiration.

[0048] The locking actuator 770 may be displaceable to discrete positions or over a continuum of positions. The locking actuator 770 may be movable from open, semi-open, and / or closed states of the seal. When the locking actuator 770 is in the semi-open position, the inner elongated member passing through the locking actuator 770 may be retracted or moved through the lumen of the catheter engaged to the inlet of the hemostasis valve, while the gasket of the locking actuator 770 provides a sufficient seal to prevent air ingress when vacuum is applied to the side port of the hemostasis valve during aspiration. Air leakage around the inner elongated member may reduce the effectiveness of the aspiration and reduce the available volume in the vacuum syringe, while a too-tight gasket seal around the inner elongated member may inhibit the inner elongated member from being easily and / or properly manipulated during the procedure. In one example application of an exemplary hemostatic valve, during a thrombectomy procedure, the microcatheter and stentriever can be retracted to retrieve the clot into the guide catheter while the guide catheter is under full vacuum with no air leakage through the gasket of the locking actuator 770.

[0049] The locking actuator can be indexed to easily and quickly select a position where it precisely seals against the elongate member to prevent air ingress, while still facilitating retraction of the elongate member through the hemostasis valve. Specifically, for thrombus removal applications, the locking actuator can be set to prevent air ingress when the elongate member is a microcatheter having an inner diameter of 0.021" or 0.017".

[0050] The hemostasis indicator may be movable to indicate which position the locking actuator is currently in. The indicator 772a may have colored portions coded to represent the state of the seal. The indicator 772a may be colored in three portions: a first portion indicating a fully open sealing operation, a second portion indicating the sheet is operable to provide an air seal to allow retraction of the elongate member, and a third portion indicating a locked closed operation. The indicator 772a may be visible through one or more windows positioned on the side of the housing of the hemostasis valve, and the indicator may be a band having three regions each of different patterns and / or colored regions, whereby the region visible through the window changes as the indicator 772a rotates. Alternatively, the indicator 772a may be visible through two windows positioned on both sides of the housing of the hemostasis valve, and the indicator 772a may be a band having six regions with the same colored regions positioned opposite each other.

[0051] Figures 7B-7I are illustrations of hemostasis indicators 772b, 772c, 772d, 772e that may be used in place of hemostasis indicator 772a with locking actuator 770 illustrated in Figure 7A. Hemostasis indicators 772b, 772c, 772d of Figures 7B-7I may each have three distinctly patterned and / or distinctly colored portions to indicate the fully open, hemostasis retracted, and locked modes of operation described with respect to Figure 7A, and each indicator 772b, 772c, 772d may be a band having six regions with the same patterned and / or colored regions positioned opposite one another on the band. As illustrated in Figures 7B and 7C, the hemostasis indicators may have dark portions, striped portions, and light portions. As illustrated in Figures 7D and 7E, hemostasis indicator 772c may have a dark portion, a diagonally bisected portion with a dark color on one half of the diagonal and a light color on the other half of the diagonal, and a light portion. As illustrated in Figures 7F and 7G, hemostasis indicator 772d may have three solid color portions, each portion having a different solid color. As illustrated in Figures 7H and 7I, hemostasis indicator 772e may have three regions, each region having a distinct solid color.

[0052] 8A-8D are illustrations of an exemplary system 800 including an aspiration control device 820 having a trigger control interface 840 integrated with a hemostasis valve 860. Figures 8A and 8B illustrate the aspiration control device in an initial position, with Figure 8B being a cross-sectional view of the components of the aspiration control device 820. Figures 8C and 8D illustrate the aspiration control device in a retracted position, with Figure 8D being a cross-sectional view of the components of the aspiration control device 820.

[0053] 8A-8D collectively, an integrated suction control device 820 and hemostatic valve 860 may be integrated into a common housing. The integrated device may have an inlet 862 sized to receive and hemostatically seal the catheter 802, an outlet 864 sized to allow passage of the inner elongate member 808 and to hemostatically seal the inner elongate member 808, a side port 866 designed to connect with a vacuum system, an aspiration control valve 822 in communication with the side port 866, a trigger control interface 840 for operating the control valve 822 to regulate aspirated blood flow, a locking actuator 870 positioned at the outlet 864 and including a hemostatic seal, and a hemostatic indicator 872 for indicating the status of the hemostatic seal at the outlet 864.

[0054] The control valve 822 may be positioned in a flow path extending from the lumen 803 of the guide catheter 802 to the side port 866, and the control valve 822 may regulate the amount of aspirated blood flow through the flow path. The trigger control interface 840 may extend between a joint 850 positioned near the outlet lock actuator 870 and a grooved sleeve 854 positioned around a portion 844 of the housing that extends toward the side port 866. The trigger 840 may bend at the joint 850, and the grooved sleeve 854 may slide along the portion 844 of the housing. The housing portion 844 may define the length of travel of the trigger 840 such that the trigger is in an initial, or fully extended, position when the trigger is bent toward the side port 866 as illustrated in FIGS. 8A and 8B, and is in a final, or fully retracted position when the trigger is bent toward the body of the hemostasis valve 860 as illustrated in FIGS. 8C and 8D. Trigger 840 may be spring loaded to return to an initial position, as illustrated in Figures 8A and 8B, when trigger 840 is not being actuated.

[0055] The integrated suction control device / hemostasis valve apparatus may be grasped in one hand with the thumb positioned on thumb grip 848 near outlet lock actuator 870, the index finger positioned on trigger 840, and the remaining fingers positioned on the apparatus and guide catheter 802 to stabilize guide catheter 802. Trigger 840 may be moved from an initial position to a final position by squeezing the index finger toward the thumb.

[0056] 8B and 8D, the suction control device 820 may include a control valve 822 including a compressible tube 824 having an opening 826 that is movable through a range of dimensions in response to being compressed or released by a compression element 842 in communication with a trigger 840. The suction control device 820 may be a normally closed device. In an initial position as illustrated in FIG. 8B, the compression element 842 may extend through an opening 846 in a housing 844 to provide maximum compression to the compressible tube 824. As the trigger 840 moves from the initial position as shown by the arrow, a grooved sleeve 854 may move over the housing portion 844. As the grooved sleeve 854 moves away from the side port 866, the compression element 842 may move into a groove 855 in the grooved sleeve 854 as illustrated in FIG. 8D. Compression element 842 may be spring loaded, or compression element 842 may be free to slide through opening 846 in housing 844 and is moved into groove 855 as a result of elastic recovery expanding compression tube 824 and pushing against compression element 842. As compression element 842 moves into groove 855, compression tube 824 may expand to allow greater flow through control valve 822.

[0057] The groove 855 may be angled such that as the grooved sleeve 854 is moved along the housing portion 844 and away from the side port 866, progressing from the initial position illustrated in FIG. 8B to the retracted position illustrated in FIG. 8D, the compression element 842 may move progressively further into the grooved sleeve 854, allowing the opening 826 in the compressible tube 824 to increase. The amount of blood flow aspirated may be controlled by the size of the opening 826 in the compressible tube 824. Thus, the blood flow rate may be selected by the user over a continuum of blood flow rates by holding the trigger 840 in a position between the initial position and the fully retracted position. The trigger 840 may be spring loaded to return to the initial position when not actuated.

[0058] 9A-9C are illustrations of an exemplary system 900 including an aspiration control device 920 having a two-finger grip interface 940 integrated with a hemostasis valve 960. Figures 9B and 9C are cross-sectional views of the components of the aspiration control device 920 shown in Figure 9A, where the aspiration control device 920 is illustrated in an initial position in Figures 9A and 9B, and where the aspiration control device 920 is illustrated in a retracted position in Figure 9C.

[0059] 9A-9C collectively, the suction control device 920 and the hemostatic valve 960 may be integrated into a common housing. The integrated device may have an inlet 962 sized to receive and hemostatically seal the catheter 902, an outlet 964 sized to allow passage of the inner elongate member 908 and to hemostatically seal the inner elongate member 908, a side port 966 designed to connect to a vacuum system, a suction control valve 922 in communication with the side port 966, a two-finger grip interface 940 for manipulating the control valve 922 to regulate the flow of aspirated blood, a locking actuator 970 positioned at the outlet 964 and having a hemostatic seal, and a hemostatic indicator 972 for indicating the status of the hemostatic seal at the outlet 964.

[0060] The control valve 922 may be positioned in a flow path extending from the lumen 903 of the guide catheter 902 to the side port 966, and the control valve 922 may regulate the amount of aspirated blood flow through the flow path. The control interface 940 may have a grooved sleeve 954 surrounding a portion 944 of the integrated device housing near the side port 966. The grooved sleeve 954 may slide along the portion 944 of the housing. The housing portion 944 may define the length of travel of the trigger 940 such that the trigger is in an initial, or fully extended, position when the trigger is positioned closest to the side port 966, and the trigger 940 is in a final, or fully retracted position when the trigger is closest to the body of the hemostasis valve 960. The trigger 940 may be spring loaded to return to the initial position when the trigger 940 is not being manipulated. The trigger 940 may have two arms extending from either side of the grooved sleeve 954.

[0061] The integrated suction control / hemostasis valve device may be grasped in one hand with the thumb positioned on the thumb grip 948 near the outlet lock actuator 970, the index finger positioned on one arm of the two-finger trigger 940, the middle finger positioned on the other arm of the two-finger trigger 940, and the remaining fingers positioned on the device and guide catheter 902 to stabilize the guide catheter 902. The trigger 940 may be moved from an initial position to a final position by squeezing the index and middle fingers toward the thumb.

[0062] 9B and 9C, the suction control device 920 may include a control valve 922 including a compressible tube 924 having an opening 926 that is movable through a range of dimensions in response to being compressed or released by a compression element 942. The compression element 942 may be in communication with a trigger 940 by a grooved sleeve 954. The suction control device 920 may be a normally closed device. In an initial position as illustrated in FIG. 9B, the compression element 942 may extend through an opening 946 in the housing 944 to provide maximum compression to the compressible tube 924. As the trigger 940 moves from the initial position as shown by the arrow in FIG. 9C, the grooved sleeve 954 may move over a portion 944 of the housing and away from the side port 966. As the grooved sleeve 954 moves away from the side port 966, the compression element 942 may move into a groove 955 in the grooved sleeve 954.

[0063] The compression element 942 may be spring loaded or may slide freely through an opening 946 in the housing 944, and is moved into the groove 955 as a result of elastic recovery expanding the compression tube 924 and pushing against the compression element 942. As the compression element 942 moves into the groove 955, the compression tube 924 may expand to allow for a greater flow rate through the control valve 922. The groove 955 may be angled such that as the grooved sleeve 954 is moved along the housing portion 944, as shown by the arrow, and away from the side port 966, the compression element 942 may move progressively further into the grooved sleeve 954, allowing the opening 926 in the compressible tube 924 to increase. The amount of blood flow aspirated may be controlled by the size of the opening 926 in the compressible tube 924. Thus, the blood flow rate may be selected by the user over a continuum of blood flow rates by holding the trigger 940 in a position between an initial position and a fully retracted position. The trigger 940 may be spring loaded to return to an initial position when not actuated.

[0064] 10A-10C are illustrations of an exemplary system 1000 including a suction control device 1020 having a lever interface 1040 integrated with a hemostasis valve 1060, with FIG 10A illustrating the lever interface 1040 in an initial position, FIG 10B illustrating the lever interface 1040 in a retracted position, and FIG 10C illustrating a cutaway view of FIG 10B. Referring collectively to FIG 10A-10C, the suction control device 1020 and the hemostasis valve 1060 may be integrated into a common housing. The integrated device may have an inlet 1062 sized to receive and hemostatically seal the catheter 1002, an outlet 1064 sized to allow passage of the inner elongate member 1008 and to hemostatically seal the inner elongate member 1008, a side port 1066 designed to connect to a vacuum system, a suction control valve 1022 in communication with the side port 1066, a rotating lever interface 1040 for operating the control valve 1022 to regulate the flow of aspirated blood, a locking actuator 1070 positioned at the outlet 1064 and having a hemostatic seal, and a hemostatic indicator 1072 for indicating the status of the hemostatic seal at the outlet 1064.

[0065] The control valve 1022 may include a flexible tube 1024 positioned to extend through a flex joint 1050 in a housing of an integrated device. The flex joint 1050 may be positioned between a body of the hemostasis valve 1060 and a side port 1066. The housing may be bent at the joint 1050 to bend the flexible tube 1024. As the flexible tube 1024 bends, an opening 1026 in the tube 1024 may be resized.

[0066] A control valve 1022 may be positioned in a flow path extending from the lumen 1003 of the guide catheter 1002 to the side port 1066, and the control valve 1022 may regulate the amount of aspirated blood flow through the flow path. A lever 1040 portion of the aspiration control device 1020 may be bent at a joint 1050 from an initial, or fully extended, position illustrated in FIG 10A to a fully retracted position illustrated in FIG 10B. The aspiration control device 1020 may include a spring 1032 positioned to return the lever 1040 to the initial position when the trigger 1040 is not being manipulated.

[0067] The integrated suction control device / hemostasis valve apparatus may be grasped in one hand with the thumb positioned on the thumb grip 1048 near the outlet lock actuator 1070, the index finger positioned on the lever 1040, and the remaining fingers positioned on the apparatus and guide catheter 1002 to stabilize the guide catheter 1002. The lever 1040 may be moved from an initial position to a final position by squeezing the index finger toward the thumb.

[0068] 10A and 10C, the flexible tube 1024 may have an opening 1026 that is movable through a range of dimensions in response to the flexible tube 1024 being bent when the lever 1040 is moved. The suction control device 1020 may be a normally open device. In an initial position, the flexible tube 1024 may be substantially straight as illustrated in FIG. 10A. The opening 1026 may be at its widest opening in its largest dimension when the flexible tube 1024 is substantially narrow and the lever is in the initial position 1040. So configured, in the initial position, the suction control device 1020 may allow maximum blood flow. When the lever 1040 is moved from the initial position in the direction indicated by the arrow in FIG. 10A, the bending of the flexible tube 1024 may cause the opening 1026 to constrict as illustrated in FIG. 10C, thereby restricting blood flow. Thus, the blood flow rate may be selected by the user over a continuum of blood flow rates by holding the lever 1040 in a position between the initial position and the fully retracted position. When the lever 1040 is released, the lever 1040 may be returned to the initial position by the spring 1032.

[0069] 11A-11F are illustrations of exemplary systems 1100, 1100a including an aspiration control device 1120 having a thumb trigger 1140 integrated with a hemostasis valve 1160. FIGS. 11A and 11B illustrate a system having a thumb trigger 1140 that is free-sliding, while FIGS. 11C-11F illustrate a system having a thumb trigger 1140a that can be ratcheted into one or more predetermined positions and held in place until the ratchet is released. FIGS. 11A, 11C, and 11D illustrate the thumb triggers 1140, 1140a of each respective exemplary system 1100, 1100a in an initial position, and FIGS. 11B, 11E, and 11F illustrate the thumb triggers 1140, 1140a of each respective exemplary system 1100, 1100a in a compressed position. Figure 11D is a cutaway view illustrating the compression element 1142 and control valve 1122 positioned as in Figure 11C. Figure 11F is a cutaway view illustrating the compression element 1142 and control valve 1122 positioned as in Figure 11E. With reference collectively to Figures 11A-11F, each respective integrated suction control device 1120, 1120a and hemostasis valve 1160 may be integrated into a common housing. Each integrated device may have an inlet 1162 sized to receive and hemostatically seal the catheter 1102, an outlet 1164 sized to allow passage of the inner elongate member 1108 and to hemostatically seal the inner elongate member 1108, a side port 1166 designed to connect to a vacuum system, a suction control valve 1122 in communication with the side port 1166, a control interface 1140, 1140a for operating the control valve 1122 to regulate the flow of aspirated blood, and a locking actuator 1170 positioned at the outlet 1164.

[0070] In addition to the features common to the exemplary systems 1100, 1100a, the exemplary system 1100 illustrated in FIGS. 11A and 11B also includes a suction blood flow indicator 1152 for indicating the blood flow rate through the control valve 1122 and a hemostatic indicator 1172 for indicating the status of the hemostatic seal at the outlet 1164, and the exemplary system 1100a illustrated in FIGS. 11C and 11F includes a ratchet release lever 1143 and ratchet interface 1153 that can be used to hold the thumb trigger 114 in a retracted position, and a second side port 1168.

[0071] With reference to the exemplary system 1100 illustrated in Figures 11A and 11B, the thumb trigger 1140 can move from an initial position illustrated in Figure 11A to a compressed configuration illustrated in Figure 11B. The thumb trigger 1140 can be spring loaded to return to the initial position when the trigger 1140 is not being manipulated. With reference to the exemplary system 1100a illustrated in Figures 11C and 11D, the thumb trigger 1140a can move from an initial position illustrated in Figure 11C to a compressed configuration illustrated in Figure 11D. The thumb trigger 1140a can be spring loaded by a spring 1132. The thumb trigger 1140a can be ratcheted to hold it in a fully or partially retracted position. The user can press the thumb trigger 1140a to further retract the thumb trigger 1140a as shown by the arrow in FIG. 11D, and the user can return the thumb trigger 1140a to its initial position by pressing the ratchet release lever 1143 as shown by the arrow in FIG. 11C, thereby releasing the ratchet interface 1153 and allowing the spring 1132 to return the thumb trigger 1140a.

[0072] In either exemplary system 1100, 1100a, the integrated suction control / hemostasis valve device may be grasped in one hand with the thumb positioned on the thumb trigger 1140, 1140a and the other fingers positioned on the housing of the integrated device and guide catheter 1102 to stabilize the device and guide catheter 1102 and provide leverage to compress the thumb trigger 1140, 1140a. The index finger may be positioned near the side port 1166 and the little finger may be positioned on the guide catheter 1102. The thumb trigger 1140, 1140a may be moved from an initial position illustrated in FIG. 11A or FIG. 11C to a compressed position illustrated in FIG. 11B or FIG. 11D by squeezing the thumb toward the other fingers as shown by the arrows in FIG. 11B or FIG. 11D.

[0073] 11A-11F collectively, in either system 1100, 1100a, a control valve 1122 may be positioned in a flow path extending from the lumen 1103 of the guide catheter 1102 to the side port 1166, and the control valve 1122 may regulate the amount of aspirated blood flow through the flow path. The control valve 1122 may include a compressible tube 1124 positioned to extend through a portion 1144 of the device's housing extending between near the inlet 1162 of the hemostasis valve 160 to near the side port 1166. The portion of the housing 1144 may have an opening 1146 through which the compression element 1142 may pass to compress the compressible tube 1124. A compression element 1142 may be connected to the thumb trigger 1140, 1140a such that when the thumb trigger is compressed, the compression element 1142 moves into the opening 1146 and pushes against the compressible tube 1124, compressing the compressible tube 1124. When the compressible tube 1124 is compressed, the opening 1126 in the tube 1124 may narrow to reduce blood flow through the control valve 1122. The opening 1126 may move between a range of sizes in response to being compressed or released by the compression element 1142.

[0074] 11A-11F collectively, in either system 1100, 1100a, the suction control device 1120 may be a normally open device. In the initial position, the compression element 1142 may be positioned outside of an opening 1146 in a housing portion 1144, and the compressible tube 1124 may be uncompressed. In the initial position, the opening 1126 in the compressible tube 1124 may have a maximum dimension with a wide opening sized to allow maximum blood flow. The thumb trigger 1140 may be moved in the direction of the arrow shown in FIG. 11B or 11D from the initial position illustrated in FIG. 11A or 11C, and the compression element 1142 may pass through the opening 1146 in a portion 1144 of the housing that holds the compressible tube 1124 and engage the compressible tube 1124. When the compression element 1142 is pressed against the compressible tube 1124, the openings 1126 in the compressible tube 1124 may collapse restricting blood flow through the control valve 1122. When the compression element releases the compressible tubing 1124 or moves toward an initial position, the openings 1126 in the compressible tube 1124 may widen as a result of elastic recovery in the tube pressing against the open tube and / or the elastic properties of the material of the compressible tube 1124.

[0075] 11A and 11B, the thumb trigger 1140 and the compression element 1142 may be integrated into a single molded component 1156 that may be attached to a common housing of the integrated suction control device and hemostasis valve. The compression element 1142 may be fixed relative to the thumb trigger 1140, meaning that when the physician engages the thumb trigger 1140, the compression element 1142 is translated through the same distance as the thumb trigger 1140. The component 1156 may pass through a second portion 1158 of the housing. The second portion 1158 may be sized to stabilize the component 1156 relative to the entire device.

[0076] With reference to the system 1100a illustrated in Figures 11C-11F, the thumb trigger 1140a, the ratchet release lever 1143, the notch forming part of the ratchet interface 1153, and the compression element 1142 may be integrated into a single molded component 1156a, which may be attached to a common housing of the integrated suction control device and hemostasis valve. As in Figures 11A and 11B, the compression element 1142 of the system 1100a may be fixed relative to the thumb trigger 1140a, meaning that the compression element 1142 is translated through the same distance as the thumb trigger 1140a. The component 1156a may surround a second portion 1158a of the housing. The second portion 1158a may be sized to stabilize the component 1156a relative to the entire device.

[0077] While the systems 1100 and 1100a have similar designs in many respects, the use of each design can be significantly different. For the system 1100 illustrated in Figures 11A and 11B, the user can control the position of the thumb trigger 1140 and thereby the flow rate through the suction control device 1120 by squeezing and holding the thumb trigger. To select a flow rate with the system 1100 illustrated in Figures 11A and 11B, the user must apply force to the thumb trigger 1140a (except for maximum flow rate when the valve opening 1126 is fully open). For the system 1100a illustrated in Figures 11C-11F, the user can control the flow rate either by depressing the thumb trigger 1140a or by depressing the ratchet release lever 1143. Once the user has selected a flow rate with the system 1100a illustrated in Figures 11C-11F, the user can release the trigger 1140a and the lever 1143 until the user desires to adjust the flow rate. The position of the trigger 1140a may be maintained by the ratchet interface 1153, and the user does not have to apply any force to maintain the position of the trigger 1140a.

[0078] 12 is an illustration of an exemplary system 1200 including an aspiration control device 1220 having a side grip interface 1240 integrated with a hemostasis valve 1260. The side grip interface 1240 may include a button that is compressible to vary the flow rate of aspirated blood through the aspiration control device 1220. The catheter 1202 may be received by an inlet 1262 of the hemostasis valve 1260, and the aspiration control device 1220 may be positioned in a flow path from the catheter 1202 to a side port 1266 of the hemostasis valve 1260. The side port 1266 may be sized to be connected to a vacuum system, such as a vacuum pump or syringe. The aspiration control device 1220 may have an internal valve with an opening that may be adjusted by depressing the side grip 1240. The suction control device 1220 can be positioned so that the physician can adjust the flow rate through the flow path using the side grips 1240 while simultaneously stabilizing the guide catheter 1202 and withdrawing a pull wire or other internal elongated member from the outlet 1264 of the hemostasis valve 1260.

[0079] The side grip 1240 may be compressed as a binary switch that toggles between maximum and minimum blood flow rates. Alternatively, the side grip 1240 may be clicked at a series of flow rates, with each click selecting a progressively greater or lesser flow rate, terminating with a reset click that returns the flow rate to the starting flow rate. Alternatively, the side grip 1240 may adjust the flow rate over a series of flow rates in response to a force applied to the side grip, where the flow rate may be directly or inversely proportional to the force. In either configuration, the suction control device 1220 may be a normally open or normally closed device.

[0080] 13A-13E are illustrative examples of blood flow indicators that may be used to indicate blood flow through the aspiration control device. The blood flow indicators illustrated in FIGS. 13A-13E may be disposed within a flow path including a control valve of the aspiration control device. Some specific exemplary aspiration control devices 120, 420, 1120 disclosed herein include blood flow indicators 152, 452, 1152 (see FIGS. 1, 4, 11A, and 11B), which may be designed as illustrated in FIGS. 13A-13E or other designs having similar functionality. It is contemplated that other examples disclosed herein may also include blood flow indicators, such as those illustrated in FIGS. 13A-13E or other designs having similar functionality.

[0081] It is contemplated that a visual indication of blood flow may be achieved by providing a transparent material along the blood flow path so that blood in the flow path may be seen by a physician or user. FIG. 13A illustrates a pinwheel flow indicator that may be positioned in the flow path and housed by a transparent material. In addition to allowing the physician to see the presence of blood in the flow path, a pinwheel may be visible through the transparent material along the blood flow path. The pinwheel may spin faster as blood flow increases, and the physician may be provided with a visual indication of blood flow by the spin rate of the pinwheel. Alternatively, blood does not need to be visible as long as at least a portion of the pinwheel is visible and that portion moves as a visual indication of blood flow.

[0082] 13B and 13C illustrate a rotating flanged barrel flow indicator that may be positioned within the flow path and housed by a transparent material. The flange tips of the flow indicator may be visible through the transparent material along the blood flow path. The barrel may rotate faster as blood flow increases, providing the physician with a visual indication of blood flow by the velocity of the flange tips. Alternatively, the blood does not need to be visible as long as at least a portion of the flow indicator is visible and it moves as a visual indication of blood flow.

[0083] 13D and 13E illustrate a rotating striped band with angled blades extending from the inner circumference of the band to a central node. The blades may be positioned along the blood flow path, and as blood flows over the angled blades, the indicator may rotate circumferentially with a spin rate determined by the blood flow rate. The striped circumference of the band may be visible by a physician, and the spin rate of the band may provide a visual indication of the flow rate. The band may be made visible by being positioned within a transparent housing or by being positioned such that it is visible through an opening in an opaque housing.

[0084] 14A is an illustration of an exemplary system 1400 including an aspiration control device 1420 controlled by a push button interface 1440, the aspiration control device 1420 being integrated with a hemostasis valve 1460 within a common housing. FIGs. 14B-14D are illustrations of various aspects and configurations of the aspiration control device 1420.

[0085] The push button interface 1440 may include a button that is compressible to vary the flow rate of aspirated blood through the aspiration control device 1420. The catheter 1402 may be received by an inlet 1462 of the hemostasis valve 1460, and the aspiration control device 1420 may be positioned in a flow path from the catheter 1402 to a side port 1466 of the hemostasis valve 1460. The side port 1466 may be sized to be connected to a vacuum system, such as a vacuum pump or syringe. The aspiration control device 1420 may have an internal valve that may be adjusted by pressing the side grip 1440. The push button interface 1420 may be positioned such that a physician may simultaneously stabilize the guide catheter 1402 and withdraw a pull wire or other internal elongated member from an outlet 1464 of the hemostasis valve 1460 while using the push button 1440 to adjust the flow rate through the flow path.

[0086] As illustrated in FIG. 14B, the suction control device 1420 may include a compressible tube 1424, a housing 1444, a button 1440, and a spring 1432. The compressible tube 1424 may act as a valve 1422 having an opening 1426 that may be resized across a continuum of dimensions in response to a force applied to depress the button 1440. The housing 1444 may house the compressible tube 1424. The button 1440 may be mounted within the opening 1446 of the housing 1444 and may be attached to the housing 1444 by one or more springs 1432. The suction control device 1420 may be a normally open device, and FIG. 14B may illustrate the suction control device 1420 in an initial open position. In the initial position, the compressible tube 1424 may have the opening 1426 open to allow maximum blood flow. The button 1440 can be pressed to compress the compressible tube 1424. The suction control device 1420 can include a compression element 1442 positioned to compress the compressible tube 1424 to resize the opening 1426 when the button 1440 is pressed. The spring 1432 can provide a spring force to return the suction control device 1420 to an initial position when the button 1440 is not actuated. For the normally open configuration, the flow rate can be inversely proportional to the force applied to the button.

[0087] FIG. 14C illustrates a variation of the configuration of the spring 1432 of the suction control device 1420 described in connection with FIG. 14B.

[0088] 14D, the suction control device 1420 can be a normally closed device. One or more springs 1432 can be positioned to provide a spring force to compress the compressible tube 1424 when the push button 1440 is not actuated. Force applied to the button 1440 can move the compression element 1442, allowing the opening 1426 in the compressible tube 1424 to widen, increasing blood flow. With a normally closed configuration, the flow rate can be directly proportional to the force applied to the button 1440.

[0089] FIG. 15 is an illustration of an exemplary system 1500 including an aspiration control device 1520 integrated with a hemostatic valve 1560. The integrated aspiration control device 1520 and hemostatic valve 1560 may be integrated into a common housing. The integrated device may have an inlet 1562 sized to receive and hemostatically seal the catheter 1502, an outlet 1564 sized to allow passage of the inner elongate member and hemostatically seal the inner elongate member, a side port 1566 designed to connect to a vacuum system, an aspiration control valve in communication with the side port 1566, and a switch interface 1540 for operating the control valve to regulate the aspirated blood flow. The control valve may be positioned in a flow path extending from the lumen of the catheter 1502 to the side port 1566, and the control valve may regulate the amount of aspirated blood flow through the flow path. The switch interface 1540 may include a lever rotatable about a joint 1550 connected to the housing of the device. The control valve may have an opening that resizes as the lever of the switch interface 1540 rotates about joint 1550, thereby regulating the amount of blood flow that is aspirated. The lever of the switch interface 1540 may be spring loaded to return to a default position when not being manipulated. Alternatively, the switch interface 1540 may maintain the position to which it was most recently moved when not being manipulated.

[0090] 16 is an illustration of an exemplary system 1600 including two suction control devices 1620, 1621 configured to regulate suction through two catheters 1602, 1604 with two hemostasis valves 1660, 1680 having a single vacuum source. The system 1600 can provide suction to the two catheters 1602, 1604 simultaneously from a single vacuum source. The suction control devices 1620, 1621 can provide control such that the simultaneous suction provided to each of the catheters 1602, 1604 is different from the other.

[0091] The system 1600 may include a first hemostatic valve 1660 having an inlet 1662 sized to receive and hemostatically seal the guide catheter 1602, an outlet 1664 sized to allow passage of the intermediate catheter 1604 and hemostatically seal the intermediate catheter 1604, a first side port 1666, and a second side port 1668. The system may include a first suction control device 1620 positioned to regulate blood flow through a flow path from a lumen of the guide catheter 1602 to the first side port 1666 of the first hemostatic valve 1660. The first suction control device 1620 may be integrated into a common housing with the first hemostatic valve 1660. The first side port 1666 may be connected to a vacuum source. The second side port 1668 may be connected to the tube 1616. The first hemostasis valve 1660 may include an outlet lock actuator 1670 for engaging and sealing the intermediate catheter 1604 .

[0092] The system 1600 may include a second hemostatic valve 1680 having an inlet 1682 positioned to receive and hemostatically seal the intermediate catheter 1604, an outlet 1684 sized to allow passage of and hemostatically seal an inner elongate member 1608, such as a pull wire or shaft of a clot removal device, and a third side port 1686. The system may include a second suction control device 1621 positioned to regulate blood flow through a flow path from a lumen of the intermediate catheter 1604 to the third side port 1686. The second suction control device 1621 may be a stand-alone component connectable to the third side port 1686. Alternatively, the second suction control device 1621 may be integrated with the second hemostatic valve 1680. The third side port 1686 may be sized to be connected to a second suction control device 1621 , which may be connected to the tube 1616 .

[0093] The system 1600 may include two flow paths for simultaneously providing suction to each catheter 1602, 1604. The two flow paths may meet within a control valve of the first suction control device 1620 and receive vacuum pressure from a vacuum source connected at a first side port 1666 of the first hemostatic valve 1660. The first flow path may extend from a lumen of the guide catheter 1602 to the first side port 1666 of the first hemostatic valve 1660. The second flow path may extend from the lumen of the intermediate catheter 1604, through the side port 1686 (third side port) of the second hemostatic valve 1680, through the second control valve of the second suction control device 1621, through the tube 1616, through the second side port 1668 of the first hemostatic valve 1660, through the control valve of the first suction control device 1620, to the first side port 1666 of the first hemostatic valve 1660. Because the first and second flow paths merge in the first control valve of the first suction control device 1620, the control valve may regulate a first aspirated blood flow rate through the first flow path and a second aspirated blood flow rate through the second flow path. The second suction control device 1621 may be operated to reduce the suction force in the second flow path compared to the first flow path such that the vacuum pressure applied to each flow path is different.

[0094] This setup may be particularly advantageous in thrombectomy procedures when the intermediate catheter 1604 is used with the guide catheter or sheath 1602. A second hemostasis valve 1660 with suction control 1621 may be connected to the intermediate catheter 1604, and an extension tube 1616 may connect suction flow to the first hemostasis valve 1660 connected to the guide catheter or sheath 1602. A single vacuum source connected to the suction control valve 1666 may facilitate backflow through the guide catheter 1602 and the intermediate catheter 1604 when the suction control valve is retracted, which is particularly beneficial for preventing clot embolism as the tip of the intermediate catheter 1604 enters the tip of the guide catheter 1602. This may also be highly beneficial when a stentriever is used with the intermediate catheter 1604 and guide catheter 1602, especially when the stentriever is partially withdrawn into the intermediate catheter 1604 and the stentriever and intermediate catheter 1604 are withdrawn as a single unit, such as during an EPIC technique. To facilitate this, the vacuum extension tube 1616 may have a longer length than the intermediate catheter and may be coiled or stretchable for ease of handling. In some thrombectomy procedures, the first hemostatic valve 1660 may be a standard hemostatic valve and need not include an additional suction control 1620.

[0095] The first suction control device 1620 and the second suction device 1621 may be designed according to the examples and principles disclosed herein and need not be specially designed as illustrated in FIG.

[0096] 17 is an illustration of an exemplary system 1700 including an aspiration control device 1720 that includes an electrical actuator. As illustrated, the aspiration control device 1720 may be integrated with a hemostatic valve 1760. The integrated aspiration control device 1720 and hemostatic valve 1760 may be integrated into a common housing. The integrated device may have an inlet 1762 sized to receive and hemostatically seal the catheter 1702, an outlet 1764 sized to allow passage of the inner elongate member 1708 and hemostatically seal the inner elongate member 1708, a side port 1766 designed to connect with a vacuum system, an aspiration control valve in communication with the side port 1766, and a control interface 1740 for operating the control valve to regulate the flow of aspirated blood. The control valve may be positioned in a flow path extending from a lumen of the catheter 1702 to the side port 1766, and the control valve may regulate the amount of aspirated blood flow through the flow path. Although not illustrated, it is contemplated that an external suction control device 120, such as that illustrated in FIG. 1, may include an electrical interface.

[0097] The control valve may have an opening that is sized in response to an electrically actuated mechanism, such as a motor. The electrical actuator may be programmed to have a predefined sequence of a set of flow rates and / or valve opening positions that the physician may select via the interface 1740. When the electrical actuator is actuated, the opening of the control valve may be sized based on the selected program.

[0098] In some instances, the program may include a particular waveform or flow pattern. In some applications, it may be advantageous to pulse or vary the vacuum to increase the likelihood that the catheter can fully aspirate the clot, or if the clot has a high fibrin content and cannot be fully aspirated, and the pulsating vacuum may allow the catheter to get an improved grip on the clot. This may be beneficial when the aspiration control valve is used with balloon guide catheters, guide sheaths, intermediate or other catheters used in thrombectomy.

[0099] The control interface 1740 may include mechanisms for selecting a program for the electric actuator and activating the electric actuator to execute the program. The interface 1740 includes mechanical inputs that may be manipulated by the physician to activate the electric actuator, such as sliders, push buttons, switches, wheels, triggers, grips, levers, rotary valves, handles, and / or other mechanisms, such as those described in connection with the mechanically controlled aspiration control valve. Additionally or alternatively, the interface 1740 may include a touch screen, a touch pad, multiple push buttons, a text and / or video display, or other type of electronic device user interface.

[0100] Figures 18-20 are flow diagrams each including method steps for controlling suction during thrombectomy. Figure 21 is a flow diagram including method steps for a clot retrieval procedure. The method steps may be performed by any of the exemplary systems, devices, and / or apparatus described herein or by means known to one of skill in the art. Method steps from one or more of methods 1800, 1900, 2000, 2100 may be combined.

[0101] With reference to method 1800 outlined in FIG. 18, at step 1808, a hemostasis valve having a distal port and a side port may be provided. At step 1816, an aspiration control device having a control valve and a control interface may be provided. At step 1824, the aspiration control device may be positioned proximate to the side port. At step 1832, the hemostasis valve and the control valve may be disposed within a common housing. At step 1840, a catheter may be provided. At step 1848, the catheter may be positioned within the distal port of the hemostasis valve. At step 1856, a vacuum source may be provided. At step 1864, the vacuum source may be attached to the side port. At step 1872, a flow path may be provided extending from a lumen of the catheter to the side port. At step 1880, the control interface may be operated to control a flow rate through the flow path. At step 1888, the catheter may be stabilized and the control interface may be operated simultaneously with one hand.

[0102] Referring to method 1900 outlined in FIG. 19, at step 1910, a control valve of a suction control device may be positioned within the flow path. At step 1920, a flexible tube having an opening may be positioned within the flow path. At step 1930, a housing may be provided having an opening. At step 1940, the flexible tube may be positioned within the housing. At step 1950, a compression element may be provided in communication with a control interface. At step 1960, the compression element may be positioned to engage the flexible tube. At step 1970, the compression element may be positioned within the opening in the housing. At step 1980, the compression element may be moved to resize the opening of the flexible tube by manipulating the control interface.

[0103] 20, in step 2010, the control interface may be moved from an initial position by applying a force to the control interface. In step 2020, the control interface may be released. In step 2030, the control interface may be returned to the initial position.

[0104] With reference to method 2100 outlined in FIG. 21, some or all of the steps may be performed by a physician using the exemplary systems 100, 200, 300, 400, 500, 600, 800, 900, 1000, 1100, 1100a, 1200, 1400, 1500, 1600, 1700 illustrated herein, variations thereof, and systems having equivalent functionality with balloon guide catheters, microcatheters, and clot retrieval devices for removing clots from the neurovasculature.

[0105] In step 2102, a balloon guide catheter may be positioned within the patient. The balloon guide catheter may be positioned through known procedures, for example, by first positioning a guidewire within the patient, pushing the balloon guide catheter into the patient over the guidewire and a dilator or access catheter as appropriate, and removing the guidewire and access catheter. The balloon guide catheter may have an inflatable balloon near its distal end that may be inflated during thrombectomy to block proximal blood flow. The balloon guide catheter may have a lumen for receiving one or more catheters and / or other devices as required. The distal end of the balloon guide catheter may be positioned near the internal carotid artery or the clot proximal to the clot.

[0106] In step 2104, a balloon guide catheter can be attached to the inlet of a hemostasis valve. The hemostasis valve can be one of the exemplary hemostasis valves described and illustrated herein, a variation thereof, or a functionally equivalent hemostasis valve.

[0107] In step 2106, a microcatheter and a clot retriever device may be positioned for the procedure. The microcatheter may be positioned such that a distal portion of the microcatheter passes through the clot, a majority of the length of the microcatheter passes through the balloon guide catheter, the microcatheter passes through an inlet of the hemostasis valve, and a proximal end of the microcatheter is positioned within the hemostasis valve. A valve at the inlet of the hemostasis valve may be fully opened while the microcatheter is positioned. The clot retrieval device may be introduced through the microcatheter after the microcatheter is positioned across the clot using standard interventional techniques. A portion of the clot retriever configured to extend within the clot may be positioned within a portion of the microcatheter positioned within the clot. A valve at the inlet of the hemostasis valve may be locked to the microcatheter while the clot retrieval device is delivered into the microcatheter.

[0108] At step 2108, the clot retriever may be deployed. To deploy the clot retriever, the microcatheter may be retracted such that the clot retriever maintains its position within the clot while the distal end of the microcatheter is proximal to the clot. In this manner, the clot retriever may be unshrouded and, once unshrouded, may expand within the clot. While the microcatheter is being retracted, the inlet valve of the hemostatic valve may be locked in an intermediate position around the microcatheter to minimize blood loss.

[0109] In step 2110, a suction control valve can be closed at a side port of the hemostasis valve. The suction control valve can be integrated into the hemostasis valve or can be attached to the side port as described and illustrated in the examples herein, variations thereof, or a suction control valve with equivalent functionality.

[0110] In step 2112, a vacuum may be created at the side port. The vacuum may be created by attaching a luer lock syringe to the side port and retracting its plunger by connecting a vacuum pump or other means. A closed suction control valve may prevent flow through the side port.

[0111] In some procedures, it may be advantageous to close the suction control valve and generate a vacuum as described in steps 2110 and 2112 before or after any of steps 2102, 2104, 2106, or 2108. The physician can choose the order that makes it easier to handle the system based on their own preferences. In either case, the suction control valve is preferably closed before the vacuum is applied to the side port to prevent premature suction.

[0112] In step 2114, the aspiration control valve may be opened to a low flow position. The aspiration control valve may be opened by manipulating the aspiration control valve with a control interface, actuator, trigger, slider, lever, or other interface, variations thereof, and equivalent functionality as described and illustrated in the examples herein. Before the aspiration valve is opened, a balloon on the balloon guide catheter may be inflated to occlude blood flow in the patient's blood vessel.

[0113] When the suction control valve is open, blood can flow from within the patient's blood vessel into the balloon guide catheter and is free to draw the clot into the catheter. Alternatively, or in addition, the balloon guide catheter can be configured to occlude the vessel to provide reverse blood flow to improve the effectiveness of the clot retrieval device to completely remove and retrieve the clot at step 2116.

[0114] In step 2118, after the clot retrieval device has been partially retracted (e.g., past the internal carotid artery terminus), the suction control device can be operated to increase the flow rate to a moderate flow rate into the syringe, pump, or other vacuum source.

[0115] In step 2021, after the clot retrieval device is further retracted (e.g., when the clot retrieval device is near the distal end of the balloon guide catheter), the suction control device can be operated to allow a high flow rate.

[0116] In step 2122, the clot retrieval device may be retracted into the balloon guide catheter while the suction control device is set to allow for a maximum flow rate. In steps 2118-2122, the microcatheter may be retracted along with the clot retrieval device.

[0117] In procedures where an intermediate or distal access catheter is used to aspirate the clot without the use of an additional clot retrieval device, such as a Direct Aspiration First Pass Technique (ADAPT), the exemplary valve system described herein may be used to control or regulate the vacuum applied to the catheter via a vacuum pump or syringe. The aspiration control valve may be used to give the physician an ergonomic and simple means of control over the aspiration flow rate while maintaining control of the catheter and without having to leave the patient's side to change pump settings.

[0118] The descriptions contained herein are examples of embodiments of the present invention and are not intended to limit the scope of the present invention in any way. As described herein, the present invention contemplates many variations and modifications of systems and devices for aspirating blood flow, including integrating the suction control device with another other treatment device, attaching the suction control device to another conventional treatment device, utilizing one or more suction control devices to control flow through one or more flow paths, using various configurations of control valves, using various configurations of control interfaces, utilizing various combinations of components to achieve the described functions, utilizing alternative materials to achieve the described functions, combining components from various examples, combining components from various examples with known components, and the like. The present invention contemplates the substitution of component parts illustrated herein with known component parts, including known control valves, control interfaces, indicators, and the like. These modifications would be apparent to one skilled in the art to which the present invention pertains, and are intended to be within the scope of the following claims.

[0119] [Embodiment] (1) A system comprising: a hemostasis valve including an inlet for receiving a catheter; a control valve in communication with the hemostasis valve, the control valve including an opening movable between a first dimension sized to restrict the flow of aspirated blood from the catheter to a first flow rate and a second dimension sized to restrict the flow of aspirated blood from the catheter to a second flow rate; a control interface in communication with the control valve, the control interface being movable to move the opening of the control valve from the first dimension to the second dimension. (2) The system described in embodiment 1, wherein the hemostasis valve further comprises a side port, and the control valve is disposed adjacent to the side port. (3) The system of embodiment 2, wherein the control valve is positioned to provide a flow path for the flow of the aspirated blood, the flow path extending from the catheter, through the control valve, to the side port. (4) The system of embodiment 1, wherein the control valve, the control interface, and the hemostasis valve are fixed to a common housing. (5) The system of embodiment 1, wherein the control interface is positioned to enable a user to select one of the first flow rate or the second flow rate with one hand while stabilizing the catheter with the other hand.

[0120] (6) The system of embodiment 1, wherein the control interface is movable to select at least one of the first flow rate or the second flow rate based at least in part on a force applied to the control interface. (7) The system of embodiment 1, wherein the opening is movable over a continuum between the first dimension and the second dimension such that the flow of the aspirated blood is controllable over a continuum between the first flow rate and the second flow rate. (8) The hemostasis valve is an outlet sized to pass an inner elongate member disposed within a lumen of the catheter; a seal disposed proximate the outlet; and a locking actuator displaceable to open the seal in a first position, to partially open the seal in a second position, and to close the seal in a third position; 2. The system of claim 1, further comprising a hemostasis indicator movable to provide a visual indication of the position of the locking actuator. (9) The hemostasis indicator comprises an indexed indicator corresponding to a predetermined half-open position of the locking actuator; in the predetermined semi-open position, the locking actuator is sized to permit the inner elongated member, including an inner diameter of about 0.017 inches to about 0.021 inches, to slidably translate through the locking actuator; 9. The system of claim 8, wherein in the predetermined semi-open position, the locking actuator is sized to prevent air from entering the hemostasis valve from around the inner elongated member. (10) An apparatus comprising: a distal port sized to receive a catheter; a proximal port sized to permit passage of an inner elongate member therethrough, the inner elongate member being disposed within a lumen of the catheter; A first side port; a first flow path extending from the lumen of the catheter to the first side port; a control valve in communication with the lumen of the catheter and the first side port, the control valve being movable to control blood flow through the first flow path; a control interface in communication with the control valve, the control interface including at least two positions, the at least two positions corresponding to at least two flow rates of the blood flow through the first flow path.

[0121] (11) The device of embodiment 10, wherein the control interface includes a sliding button positioned to enable a user to simultaneously select one of the at least two positions with one hand while stabilizing the catheter with the other hand. (12) The device of embodiment 10, wherein the control interface includes a push button that is movable between the at least two positions as a result of a force applied to the push button, and the push button is positioned to enable a user to simultaneously select one of the at least two positions with one hand while stabilizing the catheter with the other hand. (13) a second side port; a second flow passage extending from the second side port to the first side port, the control valve is in communication with the second side port and the first side port; 11. The device of embodiment 10, wherein the control valve is movable to control the blood flow through the second flow path. (14) A method for aspirating a blood flow, comprising: providing a hemostasis valve having a distal port and a side port; providing a suction control device comprising a control valve and a control interface; positioning the suction control device adjacent to the side port; Providing a catheter; Positioning the catheter within the distal port of the hemostasis valve; providing a vacuum source; providing a flow path from a lumen of the catheter to the side port; positioning the control valve of the suction control device within the flow path; providing a vacuum to the flow path using the vacuum source; and manipulating the control interface to control a flow rate through the flow path. (15) The method of embodiment 14, further comprising simultaneously operating the control interface with one hand while stabilizing the catheter with a first hand.

[0122] (16) The method of embodiment 14, further comprising disposing the hemostasis valve and the suction control device within a common housing. (17) Positioning a flexible tube within the flow path, the flexible tube including an opening; providing a compression element in communication with the control interface; positioning the compression element into engagement with the flexible tube; 15. The method of claim 14, further comprising: moving the compression element to resize the opening in the flexible tube by manipulating the control interface. (18) Providing a housing including an opening; Positioning the flexible tube within the housing; 18. The method of claim 17, further comprising positioning the compression element within the opening in the housing. (19) Operating the control interface to control a flow rate through the flow path, 15. The method of claim 14, comprising moving the control interface from an initial position by applying a force to the control interface. (20) releasing the control interface; and 20. The method of claim 19, further comprising returning the control interface to the initial position.

Claims

1. 1. A system comprising: a hemostasis valve including an inlet for receiving a catheter; a control valve in communication with the hemostasis valve, the control valve comprising a section of compressible tubing including an opening movable between a first dimension sized to restrict the flow of aspirated blood from the catheter to a first flow rate and a second dimension sized to restrict the flow of aspirated blood from the catheter to a second flow rate; a control interface in communication with the control valve, and a compression element in communication with the control interface, the compression element movable to move the opening of the control valve from the first dimension to the second dimension; the compression element is spring loaded or connected to a trigger with a spring force such that when the trigger is released, the compression element is configured to move as a result of the spring force and expand within an opening in a housing portion, thereby moving the trigger toward an initial position and narrowing the opening in the compressible tube.

2. The system of claim 1 , wherein in the initial position, the compression element is configured to extend through the opening in the housing to provide maximum compression to the compressible tube.

3. The system of claim 2 , wherein the compression element is configured to engage an edge of the opening in the housing and bend away from the compressible tube when the trigger is moved from the initial position.

4. 4. The system of claim 3, wherein the compression element is configured to transition from the initial position to a retracted position as a result of the trigger being squeezed away from the side port, wherein in the retracted position the compression element is bent to move out of the opening in the housing.

5. 5. The system of claim 4, wherein in the retracted position, when the compression element flexes away from the compressible tube, the opening in the compressible tube is configured to widen to allow for a greater flow rate through the control valve.

6. The system of claim 1 , wherein the hemostasis valve further comprises a first side port, and the control valve is disposed proximate to the first side port.

7. 7. The system of claim 6, wherein the control valve is positioned to provide a flow path for the flow of aspirated blood, the flow path extending from the catheter, through the control valve, to the first side port.

8. The system of any one of claims 1 to 7, wherein the control valve, the control interface, and the hemostasis valve are fixed to a common housing.

9. The system of any one of claims 1 to 8, wherein the control interface is positioned to enable a user to select one of the first flow rate or the second flow rate with one hand while stabilizing the catheter with the other hand.

10. 10. The system of claim 1, wherein the control interface is movable to select at least one of the first flow rate or the second flow rate based at least in part on a force applied to the control interface.

11. 11. The system of claim 1, wherein the opening is movable over a continuum between the first dimension and the second dimension such that the flow of the aspirated blood is controllable over a continuum between the first flow rate and the second flow rate.

12. The hemostasis valve is an outlet sized to pass an inner elongate member disposed within a lumen of the catheter; a seal disposed proximate the outlet; and a locking actuator displaceable to open the seal in a first position, to partially open the seal in a second position, and to close the seal in a third position; The system of any one of claims 1 to 11, further comprising a hemostasis indicator movable to provide a visual indication of the position of the locking actuator.

13. the hemostasis indicator comprises an indexed indicator corresponding to a predetermined semi-open position of the locking actuator; in the predetermined semi-open position, the locking actuator is sized to permit the inner elongated member, including an inner diameter of about 0.017 inches to 0.021 inches, to slidably translate through the locking actuator; The system of claim 12 , wherein in the predetermined semi-open position, the locking actuator is sized to prevent air ingress around the inner elongate member and into the hemostasis valve.

14. The system of any one of claims 1 to 13, wherein the control interface includes a sliding button positioned to enable a user to simultaneously select one of the at least two positions with one hand while stabilizing the catheter with the other hand.

15. 14. The system of any one of claims 1 to 13, wherein the control interface includes a push button movable between the at least two positions as a result of a force applied to the push button, the push button positioned to enable a user to simultaneously select one of the at least two positions with one hand while stabilizing the catheter with the other hand.

16. A second side port; and a second flow passage extending from the second side port to the first side port, the control valve is in communication with the second side port and the first side port; The system of claim 6 or 7, wherein the control valve is movable to control blood flow through the second flow path.

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