Suction control valve

Abstract

The present invention is entitled "Suction Control Valve". The present invention provides a suction control device that may have a suction control valve and a switch, button, slider, trigger, grip, lever, rotary wheel, rotary valve, handle, or other engagement portion for adjusting the size of the suction control valve. The suction control engagement portion may be conveniently positioned and configured to be operated while simultaneously stabilizing the catheter and / or retracting the elongate member. The suction control device may be integrated with a hemostatic valve, integrated with a wire gripping device, and / or attached to an inlet, outlet, hose, pump, or syringe in series with the suction flow path.

Description

Technical Field

[0001] The present invention generally relates to endovascular medicine and, more particularly, to regulating the blood flow rate of aspirated blood during thrombectomy procedures. Background Art

[0002] During endovascular medicine, it may be advantageous to slow or reverse the blood flow at the treatment site within a patient. For example, during thrombectomy, a physician may utilize a syringe or a vacuum pump to obtain reverse blood flow to facilitate the movement and removal of a stentriever-assisted clot or thrombus or direct aspiration into an intermediate catheter or access catheter. The syringe or vacuum pump may be connected to the proximal end of an intermediate catheter or a guiding catheter (e.g., a balloon guiding catheter), and the vacuum may communicate through the lumen of the catheter to the distal tip of the catheter. The syringe and vacuum pump are typically connected to a side arm of a "rotary hemostatic valve" that is attached to the proximal end of the intermediate catheter or guiding catheter. "Rotary" refers to a luer fitting that can be threaded onto the proximal end of the catheter and freely rotated to disengage the attachment, while the hemostatic feature facilitates the introduction of other catheters and accessory devices through the intermediate catheter or guiding catheter while minimizing back bleeding and blood loss. The hemostatic valve typically includes a washer that can be fully opened for device introduction or tightened to prevent any blood loss. The washer can also be tightened to grip a guide wire or microcatheter positioned within the intermediate catheter or guiding catheter. Known hemostatic valves typically include an inlet passage for receiving an accessory device or catheter in a hemostatic sealed state and a side port that can be used to admit a saline flush, an injectate such as a contrast agent, or attach a suction syringe or vacuum pump.

[0003] Known hemostatic valves may also include a passage through which a guide wire, microcatheter, intermediate catheter, device shaft, or such elongate member can pass. The passage may include a washer for hemostatically sealing the outer perimeter of the internal elongate member to minimize blood loss and grip the internal elongate member in place when needed.

[0004] During thrombectomy procedures, a syringe or vacuum pump may aspirate through the lumen of an intermediate catheter or guiding catheter to create reverse blood flow at the clot. When a vacuum pump is used, it is typically set to its maximum value and full vacuum / aspiration is applied as the clot is removed. Similarly, if a vacuum-lock syringe is used, full vacuum is typically applied to provide the maximum reverse flow rate for as long as possible until the syringe is full.

[0005] In some surgeries, a physician may desire to modify the aspiration rate during the surgery to accommodate specific aspects of the clinical case. For example, during thrombectomy, the physician may prefer to aspirate slowly at the time of initial clot movement, then increase aspiration as the clot approaches the catheter, and then further increase aspiration to a maximum when pulling the clot into the catheter. Increasing aspiration during clot removal reduces the likelihood of vessel collapse due to negative pressure in the vasculature, and when performed with a syringe, increasing aspiration can more effectively utilize the fixed volume of the syringe compared to a steadily applied vacuum. This technique requires simultaneous operation of a syringe or pump, retraction of the thrombectomy device, and stabilization of the catheter, which can be extremely difficult with conventional systems.

[0006] Accordingly, there is a need for improved methods, devices, and systems for controlling aspiration during thrombectomy surgery. Similarly, in other endovascular or medical treatments using an aspiration pump or aspiration syringe, control of the aspiration flow rate may be beneficial. Summary of the Invention

[0007] The object of the present invention is to provide a system, device, and method that meet the above requirements. Generally speaking, the object of the present invention is to provide an aspiration control device having an aspiration control valve that can be controlled by a switch, button, slider, trigger, grip, lever, rotary wheel, rotary valve, handle, or other engagement portion, and the aspiration control device is conveniently positioned and configured to be operated while simultaneously stabilizing a hemostatic valve and a catheter with one hand and / or retracting an elongate member with the other hand. The aspiration control device can be integrated into a hemostatic valve, a wire gripping 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 endovascular surgery can include a combination of one or more aspiration control devices, one or more hemostatic valves, one or more wire gripping devices, and / or one or more vacuum sources to provide and / or regulate vacuum to one or more catheters.

[0008] An exemplary system can include a hemostatic valve, a control valve, and a control interface. The hemostatic valve can have an inlet for receiving a catheter. The control valve can communicate with the hemostatic valve and can have an opening that is adjustable from a first size to a second size, the first size being sized to limit blood flow aspirated from the catheter at a first flow rate, and the second size being sized to limit blood flow aspirated from the catheter at a second flow rate. The control interface can communicate with the control valve, and the control interface can be moved to move the opening of the control valve from the first size to the second size.

[0009] The hemostatic valve may further include a side port. The control valve may be positioned near the side port. The control valve may be positioned to check out the flow path of the blood flow for aspiration, which extends from the catheter through the control valve to the side port. The control valve and the control engagement portion may be integrated with the hemostatic valve into a common housing.

[0010] The control engagement portion may be positioned to allow the user to select one of a first flow rate or a second flow rate with one hand while stabilizing the catheter with the same hand. The control engagement portion may be a button configured to select at least one of the first flow rate or the second flow rate at least partially based on the force applied to the control engagement portion. The opening of the control valve may move through a continuous dimension between the first dimension and the second dimension, such that the aspirated blood flow can be controlled at a continuous flow rate between the first flow rate and the second flow rate. The control engagement portion may be moved through a continuous position to move the opening of the control valve through a continuous dimension. The control engagement portion may be spring-loaded and may be set in a default open position or a default closed position, or a ratchet may be installed to set it in any intermediate position between fully open and fully closed.

[0011] The hemostatic valve may further include an outlet sized to pass an internal elongate member, a seal disposed near the outlet, a locking actuator displaceable to open, semi-open, or close the seal, and a hemostasis indicator movable to provide a visual indication of the position of the locking actuator. The internal elongate member may be disposed within the lumen of the catheter. The locking actuator may be displaced from a first position, a second position, and a third position, each position corresponding respectively to an open, semi-open, or closed state of the seal. The hemostasis indicator may be movable to indicate the position where the locking actuator is currently located. When the locking actuator is in the semi-open position, the internal elongate member may be retracted or moved within the catheter, while the seal provides sufficient sealing to prevent air from entering when a vacuum is applied to the side port during aspiration. During a thrombectomy procedure, the internal elongate member may be a microcatheter, and when the catheter is under full vacuum, the stentriever may be retrieved through the seal of the locking actuator to remove the clot into the catheter without air leakage.

[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 engagement portion. The distal port may be sized to receive a catheter. The proximal port may be sized to allow an internal elongate member to pass through, the internal elongate member being disposed within the 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, and the control valve may be movable to control the blood flow through the first flow path. The control engagement portion may be in communication with the control valve, and the control engagement portion may be movable between at least two positions corresponding to at least two flow rates of the blood flow through the first flow path.

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

[0014] The control junction may have a button that can be pushed forcefully to move between two or more positions while stabilizing the catheter with one hand.

[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. A control valve may be in communication with the first side port and the second side port, and the control valve may be movable to control blood flow through the second flow path.

[0016] Exemplary methods for aspirating blood flow may include some or all of the following steps and variations thereof. The steps are not recited in a specific order. A hemostatic valve having a distal port and a side port may be provided. An aspiration control device having a control valve and a control junction may be provided. The aspiration control device may be positioned near the side port. The hemostatic valve and the aspiration control valve may be disposed in a common housing.

[0017] A flow path may be provided from the lumen of a catheter positioned in the distal port to the side port. The control valve of the aspiration control device may be positioned in the flow path. A flexible tubing having an opening may be positioned in the flow path. A housing having an opening may be provided. The flexible tubing may be positioned in the housing. A compression element in communication with the control junction may be provided. The compression element may be positioned to engage the flexible tubing. The compression element may be positioned in the opening of the housing. The opening size of the flexible tubing may be adjusted by moving the compression element by operating the control junction.

[0018] A catheter may be provided and the catheter may be positioned in the distal port. A vacuum source may be provided. The vacuum source may be used to provide a vacuum to the flow path. The control junction may be operated to control the flow rate through the flow path. To operate the control junction, a force may be applied to the control junction and the control junction may be moved from an initial position by applying the force. The catheter may be stabilized with a first hand while operating the control junction with that single hand. The control junction may be released. The control junction may return to the initial position. Description of the Drawings

[0019] The above and other aspects of the invention will be further discussed with reference to the following description and in conjunction with the drawings.

[0020] In these drawings, like numbers indicate like structural elements and features in the various figures. The drawings are not necessarily to scale; rather, emphasis is placed on illustrating the principles of the invention. The drawings depict one or more specific embodiments of the inventive device by way of example and not by way of limitation.

[0021] Figure 1Illustration of a suction control valve connected to a hemostatic valve according to aspects of the present invention;

[0022] Figure 2 Illustration of a suction control device with a sliding engagement integrated into a hemostatic valve according to aspects of the present invention;

[0023] Figure 3 Illustration of a suction control device with a button engagement integrated into a hemostatic valve according to aspects of the present invention;

[0024] Figure 4 Illustration of a system according to aspects of the present invention, the system including a suction control device connected to regulate suction at two hemostatic valves;

[0025] Figure 5 Illustration of a system according to aspects of the present invention including a suction control device integrated into a wire gripping device;

[0026] Figures 6A to 6C Illustration of a suction control device with a trigger, a locking actuator, and a hemostasis indicator integrated into a hemostatic valve according to aspects of the present invention;

[0027] Figure 7A Illustration of a locking actuator according to aspects of the present invention;

[0028] Figures 7B to 7I Illustration of a hemostasis indicator according to aspects of the present invention;

[0029] Figures 8A to 8D Illustration of a suction control device with a trigger finger gripping engagement integrated into a hemostatic valve according to aspects of the present invention;

[0030] Figures 9A to 9C Illustration of a suction control device with a two-finger gripping engagement integrated into a hemostatic valve according to aspects of the present invention;

[0031] Figures 10A to 10C Illustration of a suction control device with a rod engagement integrated into a hemostatic valve according to aspects of the present invention;

[0032] Figures 11A to 11F Illustration of two variants of a suction control device with a thumb trigger engagement integrated into a hemostatic valve according to aspects of the present invention;

[0033] Figure 12 Illustration of a suction control device with a side gripping engagement integrated into a hemostatic valve according to aspects of the present invention;

[0034] Figures 13A to 13EDiagram of a blood flow indicator for a suction control device according to aspects of the present invention;

[0035] Figures 14A to 14D Diagram of a suction control device with button engagement control integrated into a hemostatic valve according to aspects of the present invention;

[0036] Figure 15 Diagram of a suction control device controlled by a switch engagement according to aspects of the present invention;

[0037] Figure 16 Diagram of a system including two suction control devices according to aspects of the present invention, the two suction control devices being configured to regulate suction at two hemostatic valves having only one vacuum source;

[0038] Figure 17 Diagram of a suction control device having an electro - actuated engagement; and

[0039] Figures 18 to 21 Flowchart of method steps for controlling suction during thrombectomy according to aspects of the present invention. Detailed Description

[0040] The examples disclosed herein generally may include a suction control device or apparatus for use with a hemostatic valve, which, compared to some conventional systems, allows a physician to more easily change the blood flow rate of the suctioned blood during endovascular treatment. The suction control device may include a control valve in the suction blood flow path and an engagement for moving the control valve to regulate the flow rate through the flow path. The flow rate at the control valve may control the reverse blood flow at the treatment site. For example, the flow rate of the reverse blood flow around a blood clot may be changed during a thrombectomy procedure by operating the suction control device.

[0041] The aspiration control device can be positioned in various locations and has control engagement portions of various configurations to enable easier use compared to conventional systems. For example, the aspiration control device can be a separate component connectable to a side port of a hemostatic valve, the aspiration control device and the hemostatic valve can be integrated into a single component, or the aspiration control device can be integrated with an auxiliary device such as a wire gripping device. The engagement portion for moving the control valve can move between two or more discrete positions or in continuous positions. Similarly, the control valve can move between two or more discrete positions or in continuous positions in response to the positioning of the engagement portion. The flow rate regulated by the control valve can be adjusted by the movement of the control valve. For example, the engagement portion can include mechanical engagement portions such as sliders, buttons, switches, wheels, triggers, grips, levers, rotary valves, handles, etc., and the engagement portion can be positioned to allow a physician to adjust the flow rate while stabilizing the catheter or sheath with only one hand, so that the physician's second hand is free to perform other activities such as removing a stentriever and a microcatheter. The engagement portion can be designed to resemble valves known to physicians such as rotary valves to provide a more intuitive engagement portion. In some examples, the aspiration control device can additionally include an electric actuator that can be programmed to provide a specific waveform or aspiration flow pattern.

[0042] Some exemplary systems with purely mechanical aspiration control devices and some exemplary systems that additionally include electric actuators can be used to open or close the vacuum to allow the vacuum to be established, thereby creating a sudden and significant pressure change in the catheter to help improve the engagement and removal of difficult thrombi.

[0043] The control valve can provide various directions to regulate the blood flow through the control valve. The control valve can include a segment of a compressible tube that can be compressed by operating the engagement portion of the aspiration control device. The valve can be in an open non-compressed state when not operated and can be compressed to restrict the flow due to operating the engagement portion, the valve can be in a closed compressed state when not operated and can be extended due to operation to increase the flow, or when not operated and moved to a different maintainable state due to operation, the valve can maintain its last compressed state, which may be a partially compressed state. For example, a spring-loaded control valve can be designed as an open or closed valve, and a rotary valve can be designed as a state-holding valve.

[0044] The aspiration control device can be designed to be used with two hemostatic valves. The first hemostatic valve provides an aspiration channel for the guiding catheter, and the second hemostatic valve provides an aspiration channel for the intermediate catheter. The aspiration control device can simultaneously adjust the vacuum through the guiding catheter and the intermediate catheter by connecting to the first hemostatic valve and the second hemostatic valve. The advantage of this configuration is the ability to provide aspiration at two hemostatic valves with a single vacuum source (e.g., a single pump or a single syringe). A second aspiration control device can be used with the two hemostatic valves and the first aspiration control device, and the second aspiration control device can be connected to the single vacuum source through the first aspiration control device. In such a configuration, the two catheters can simultaneously receive aspiration from a single vacuum with different vacuum pressures.

[0045] As an alternative or in addition, the aspiration control device can be designed to be integrated into an auxiliary device that can be used in combination with the hemostatic valve. For example, the aspiration control device can be integrated into a wire gripping device to allow the physician to control the aspiration rate with one hand while retracting the thrombectomy device and / or the microcatheter, so that the physician's second hand is free to perform other activities such as stabilizing the guiding catheter.

[0046] Figure 1 FIG. is a diagram of an exemplary system 100 including an aspiration control device 120 and a hemostatic valve 160. Figure 1 The aspiration control device 120 is shown as an independent device that can be connected to the side port 166 of the hemostatic valve 160 and can be connected to the tubing 112 of the vacuum system. The advantage of the independent aspiration control device 120 is that it can be configured to cooperate with a conventional hemostatic valve 160. The catheter 102 can be received by the inlet 162 of the hemostatic valve 160, and the aspiration control device 120 can be positioned in the flow path from the catheter 102, through the side port 166 of the hemostatic valve 160, and out of the tubing 112 of the vacuum system. The aspiration control device 120 can have an internal valve that can be adjusted by moving the control junction or actuator 140. The aspiration control device 120 can include a flow rate indicator 152 to provide a visual indication of the blood flow rate through the aspiration control device 120. The aspiration control device 120 can be positioned such that the physician can adjust the flow rate through the flow path having the junction 140 while stabilizing the guiding catheter 102 and removing the pull wire, the shaft of the thrombectomy device, or other internal elongated member 108 from the outlet 164 of the hemostatic valve 160.

[0047] Figure 2FIG. is a diagram of an exemplary system 200 that includes a suction control device 220 integrated with a hemostatic valve 260. The integrated suction control device 220 and the hemostatic valve 260 can be integrated into a common housing. The integrated device can have a luer connector to receive and hemostatically seal an inlet 262 of a catheter 202, sized to allow an inner elongate member 208 to pass through and adjustable to hemostatically seal an outlet 264 of the inner elongate member 208, a side port 266 designed to connect to a vacuum system, a control interface 240 for operating a control valve to regulate the flow of aspirated blood, and a visual indicator 252 for indicating the flow rate of aspirated blood. The control valve can be positioned in a flow path extending from the lumen of the catheter 202 to the side port 266, and the control valve can regulate the flow rate of aspirated blood through the flow path. The control interface 240 can be a slider button movable along a track 241, and the control valve can have an opening that adjusts in size as the slider 240 moves along the track 241, thereby regulating the flow rate of aspirated blood. The slider 240 can be spring-loaded such that it returns to a default position when not being operated. Alternatively, the slider 340 can hold the position it most recently moved to when not being operated.

[0048] Figure 3 FIG. is a diagram of an exemplary system 300 that includes a suction control device 320 integrated with a hemostatic valve 360. The integrated suction control device 320 and the hemostatic valve 360 can be integrated into a common housing. The integrated device can have an inlet 362 sized to receive and hemostatically seal a catheter 302, an outlet 364 sized to allow an inner elongate member 308 to pass through and hemostatically seal the inner elongate member 308, a side port 366 designed to connect to a vacuum system, a suction control valve in communication with the side port 366, and a control interface 340 for operating the control valve to regulate the flow of aspirated blood. The control valve can be positioned in a flow path extending from the lumen of the catheter 302 to the side port 366, and the control valve can regulate the flow rate of aspirated blood through the flow path. The control interface 340 can be a button movable from a fully extended state to a fully compressed state. The button 340 can be held in an intermediate state between the fully extended state and the fully compressed state. The control valve can have an opening sized according to the state of the button, and can regulate the flow rate through the flow path based on the size of the opening. The control valve can be normally open, which means that when the button 340 is fully extended, the opening of the control valve is at a maximum size to allow maximum flow rate, and when the button 340 is compressed, the opening of the control valve contracts to restrict blood flow. Alternatively, the control valve can be normally closed, which means that when the button 340 is fully extended, the opening of the control valve is at a minimum size to allow minimum flow rate, and when the button 340 is compressed, the opening of the control valve expands to allow more blood flow.

[0049] Figure 4FIG. 0 is an illustration of an exemplary system 400 that includes a suction control device 420 that is connected to regulate suction at two hemostatic valves 460, 480. System 400 can provide suction to two catheters 402, 404 from a single vacuum source 414 simultaneously, and the suction control device 420 can regulate the flow rate through both catheters 402, 404 simultaneously.

[0050] System 400 can include a first hemostatic valve 460 integrated with the suction control device 420. The integrated suction control device 420 and hemostatic valve 460 can be integrated into a common housing. The integrated device can have an inlet 462 sized to receive and hermetically seal a guide catheter 402 for hemostasis, an outlet 464 sized to allow an intermediate catheter 404 to pass through and hermetically seal the intermediate catheter 404, a first side port 466 designed to be connected to a vacuum system, a second side port 468 designed to be connected to a second hemostatic valve 480, a suction control valve in communication with the first side port 466 and the second side port 468, a control engagement portion 440 for operating the control valve to regulate the flow of suction blood, and a visual indicator 452 for indicating the flow rate of the suctioned blood through the control valve.

[0051] System 400 can include a second hemostatic valve 480 that has an inlet 482 positioned to receive the intermediate catheter 404 and hermetically seal the intermediate catheter 404, an outlet 484 sized to allow an internal elongate member 408 such as a microcatheter to pass through and hermetically seal the internal elongate member 408, and a side port 486. The side port 486 of the second hemostatic valve 480 can be connected to the second side port 468 of the first hemostatic valve 460 through tubing 416.

[0052] System 400 can include two flow paths to provide suction to each catheter 402, 404 simultaneously. The two flow paths can converge in the control valve of the suction control device 420 and receive vacuum pressure from a syringe 414 or other vacuum source connected to the first side port 466 of the first hemostatic valve 460. The first flow path can extend from the lumen of the guide catheter 402 to the first side port 466 of the first hemostatic valve 460. The second flow path can extend from the lumen of the intermediate catheter 404, through the side port 486 of the second hemostatic valve 480, through the tubing 416, through the second side port 468 of the first hemostatic valve 460, through the control valve of the suction control device 420, and extend to the first side port 466 of the first hemostatic valve 460. Since the first flow path and the second flow path converge in the control valve, the control valve can regulate the first suction blood flow rate through the flow path and the second suction blood flow rate through the flow path. The visual indicator 452 can indicate the flow rate of the suctioned blood 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.

[0053] The control junction 440 can be a slider button movable along a track 441, and the control valve can have an opening whose size is adjusted as the slider 440 moves along the track 441, thereby regulating the first blood suction flow rate and the second blood suction flow rate. The slider 440 can be spring-loaded so that it returns to its default position when not being operated. As an alternative, the slider 440 can hold the position it most recently moved to when not being operated.

[0054] Figure 5 FIG. is an illustration of an exemplary system 500 including a suction control device 520 integrated into a wire gripping device 590. The system 500 can include two hemostatic valves 560, 580. At least one of the hemostatic valves 560 can be connected to the suction control device 520 to receive suction from a vacuum source through the suction control device. The suction control device 520 can be positioned such that a physician can operate the control junction 540 of the wire gripping device 590 and the suction control device 520 simultaneously with one hand, while the physician's second hand is free to perform other tasks, such as stabilizing the guiding catheter 502.

[0055] The system 500 can include a first hemostatic valve 560 and a second hemostatic valve 580, each of the hemostatic valves having a hemostatically sealable inlet 562, 582, a hemostatically sealable outlet 564, 584, and a side port 566, 586. The hemostatic valves 560, 580 can be conventional hemostatic valves known in the art or hemostatic valves incorporating the features described herein. The first hemostatic valve 560 can receive the guiding catheter 502 at the inlet 562, pass through the intermediate catheter 504 through the outlet 564, and be connected to the tubing 516 at the side port 566. The second hemostatic valve 580 can receive the microcatheter 504 at the inlet 582, pass through the stentriever 508 or other such shaft, guide wire, or internal elongate member through the outlet 584, and have a side port 586 that can be connected to a pressure flush system, such as the side port according to a standard thrombectomy procedure.

[0056] The integrated wire gripping device 590 and suction control device 520 can be integrated into a common housing. The integrated device can have an inlet 592 for receiving and gripping the internal elongate member 508, an outlet for passing through the internal elongate member 508, a first side port 596, a second side port 598, a control valve, and a control junction 540 for the control valve.

[0057] System 500 may include a first flow path that extends from a guiding catheter 502, through a side port 566 of a hemostatic valve 560, through tubing 516, through a second side port 598 of an integrated wire / suction control device, through a control valve of a suction control device 520, and to a first side port 596 of the integrated wire / suction control device. The suction control device 520 may control the flow rate through the first flow path to regulate the aspirated blood flow through the guiding catheter 502.

[0058] The control junction 540 may be a slider button movable along a track 541, and the control valve may have an opening that adjusts in size as the slider 540 moves along the track 541, thereby regulating the blood flow rate aspirated through the guiding catheter 502. The slider 540 may be spring-loaded such that it returns to a default position when not being operated. As an alternative, the slider 540 may hold the position it most recently moved to when not being operated.

[0059] In Figure 5 an exemplary embodiment of the system 500 shown in, a physician may control aspiration while removing a microcatheter 504 and a thrombectomy device shaft 508 from the catheter 502 by operating the control junction 540. In the exemplary embodiment, the system is configured such that: the outlet 564 of the first hemostatic valve 560 may be in a semi-open position to allow the microcatheter 504 to slide past the outlet 564 while suppressing air leakage; the microcatheter 504 may be locked in place at the inlet of a second hemostatic valve 580 to restrict movement of the microcatheter 504 relative to the second hemostatic valve 580; the outlet 584 of the second hemostatic valve 580 may be locked around the stentriever shaft 508 to restrict movement of the shaft 508 relative to the second hemostatic valve 580 and the microcatheter 504; and a wire gripping device 590 may be locked to the shaft 508 to restrict movement of the shaft 508 relative to the gripping device 590. So configured, the wire gripping device 590 may move proximally relative to the first hemostatic valve 560, thereby pulling the stentriever shaft 508, the second hemostatic valve 580, and the microcatheter 504 proximally and removing the microcatheter 504 and the device 508 from the guiding catheter 502. The physician may use one hand to steady the first hemostatic valve 560 while using the other hand to simultaneously pull on the wire gripping device 590 and operate the control junction 540 on the wire gripping device 590.

[0060] Figure 6A A diagram of an exemplary system 600 including a suction control device 620 having a trigger control junction 640 integrated into a hemostatic valve 660. Figure 6B and Figure 6C is Figure 6A a cross-sectional view of the suction control device 620 shown in, wherein Figure 6BThe control engagement portion 640 is shown in the initial position. Figure 6C The control engagement portion 640 is shown in the retracted position. Referring jointly Figure 6A and Figure 6C , the integrated suction control device 620 and the hemostatic valve 660 can be integrated into a common housing. The integrated device can have an inlet 662 sized to receive and hermetically seal the catheter 602 for hemostasis, an outlet 664 sized to allow the internal elongate member 608 to pass through and hermetically seal the internal 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 engagement portion 640 for operating the control valve 622 to regulate the suctioned blood flow, a locking brake 670 positioned at the outlet 664, and a hemostasis indicator 672 for indicating the status of the hemostatic seal at the outlet 664.

[0061] The control valve 622 can be positioned in the 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 can regulate the suctioned blood flow rate through the flow path. The control engagement portion 640 can be a trigger movable along a portion 644 of the housing extending toward the side port 666. The portion 644 can define the travel length of the trigger 640 such that the trigger is in the initial or fully extended position when the trigger is closest to the side port 666, and the trigger is in the final position or fully retracted position when the trigger is closest to the body of the hemostatic valve 660. The trigger 640 can be spring-loaded to return to the initial position when the trigger 640 is not operated.

[0062] The integrated suction control / hemostatic valve device can be grasped with one hand, with the thumb positioned on the body of the device near the outlet locking actuator 670, the index finger positioned on the trigger 640, and the remaining fingers positioned on the device and the guide catheter 602 to stabilize the guide catheter 602. The trigger can be moved from the initial position to the retracted position by squeezing the index finger toward the thumb.

[0063] Referring Figure 6B and Figure 6C , the suction control device 620 can include a control valve 622 that includes a compressible tubing 624 having an opening 626 that is movable through a range of sizes in response to being compressed or released by a compression element 642 in communication with the trigger 640. The suction control device 620 can be a normally closed device.

[0064] Figure 6BThe control engagement portion 640 is shown in its initial position. In the initial position, the compression element 642 can extend through the opening 646 of the housing 644 to provide maximum compression to the compressible tubing 624. When the trigger 640 is moved away from the initial position as indicated by the larger arrow, the compression element 642 can engage the edge of the opening 646 of the housing 644 and bend away from the compressible tubing 624 as indicated by the smaller arrow.

[0065] Figure 6C The control engagement portion 640 is shown in its retracted position. As the trigger is squeezed away from the side port 666, the compression element 642 bends to move away from the opening 646 of the housing 644. When the compression element 642 bends away from the compressible tubing 624, the opening 626 of the compressible tubing 624 can expand to allow a greater flow rate through the control valve 622.

[0066] The compression element 642 can be spring-loaded or connected to the trigger 640 with spring force such that when the trigger 640 is released, the compression element 642 moves due to the spring force to extend within the opening 646 of the housing portion 644, thereby moving the trigger 640 towards the initial position (as Figure 6B shown) and restricting the opening 626 of the compressible tubing 624.

[0067] Figure 7A Illustration of an exemplary locking actuator 770 and an exemplary hemostasis indicator 772a that can be positioned at the outlet 764 of a hemostatic valve. The locking actuator 770 can be tightened by operating a rotary thumbwheel or pressing a button. The locking actuator 770 can include a washer or other seal that can be fastened to a catheter, wire, or other elongate member extending through the outlet 764 of the hemostatic valve. The locking actuator 770 can seal the elongate member against air entry during aspiration while allowing the elongate member to be withdrawn from the outlet 764.

[0068] The locking actuator 770 can be shifted to discrete or continuous positions. The locking actuator 770 can be moved from the open, semi-open, and / or closed states of the seal. When the locking actuator 770 is in the semi-open position, the internal elongate member passing through the locking actuator 770 can be retracted or moved through the lumen of a catheter engaged at the inlet of the hemostasis valve, while the gasket of the locking actuator 770 provides sufficient sealing to prevent air from entering when a vacuum is applied to the side port of the hemostasis valve during aspiration. Leakage of air around the internal elongate member can reduce the effectiveness of aspiration and decrease the available volume in the vacuum syringe; however, an overly tight gasket seal around the internal elongate member can prohibit the internal elongate member from being easily and / or properly manipulated during treatment. In an exemplary application of an exemplary hemostasis valve, during a thrombectomy procedure, a microcatheter and stentriever can be retracted to retrieve a clot into a guiding catheter while the guiding catheter is under full vacuum without leakage of air through the gasket of the locking actuator 770.

[0069] The indexable locking actuator can be easily and quickly selected to its position that precisely seals against the elongate member to prevent air entry, while also facilitating the retraction of the elongate member through the hemostasis valve. Specifically, in terms of thrombectomy, the locking actuator can be set to prevent air entry when the elongate member is a microcatheter with an inner diameter of 0.021" or 0.017".

[0070] The hemostasis indicator can be moved to indicate the current position of the locking actuator. The indicator 772a can have colored portions that are coded to represent the seal state. The indicator 772a can have three colored portions, namely a first portion indicating a fully open sealing operation, a second portion indicating that the seal is operable to provide an air seal and allow the elongate member to be retracted, and a third portion indicating a locked closed operation. The indicator 772a can be seen through one or more windows positioned on one side of the hemostasis valve housing, and the indicator can be a strip having three regions, each region having a different pattern and / or color such that the region visible through the window changes as the indicator 772a rotates. As an alternative, the indicator 772a can be seen through two windows positioned on opposite sides of the hemostasis valve housing, and the indicator 772a can be a strip having six regions with the same colored regions positioned opposite each other.

[0071] Figures 7B to 7I Illustrations of hemostasis indicators 772b, 772c, 772d, 772e, which can be used in place of the hemostasis indicator 772a having Figure 7A shown in the locking actuator 770. Figures 7B to 7I The hemostasis indicators 772b, 772c, 772d in can each have three distinguishable patterns and / or distinguishable colored portions to indicate relative toFigure 7A the fully open, hemostatic retraction, and locking operating modes, and each of the indicators 772b, 772c, 772d can be a strip having six regions with the same pattern regions and / or colored regions positioned opposite each other on the strip. As Figure 7B and Figure 7C shown, the hemostatic indicator can have a dark portion, a striped portion, and a light portion. As Figure 7D and Figure 7E shown, the hemostatic indicator 772c can have a dark portion, a diagonal bisect portion with one half diagonal dark and the other half diagonal light, and a light portion. As Figure 7F and Figure 7G shown, the hemostatic indicator 772d can have three solid color portions, each having a different solid color. As Figure 7H and Figure 7I shown, the hemostatic indicator 772e can have three regions, each having a distinguishable solid color.

[0072] Figures 8A to 8D is a diagram of an exemplary system 800 including a suction control device 820 having a trigger control engagement portion 840 integrated with a hemostatic valve 860. Figure 8A and Figure 8B show the suction control device in an initial position, where Figure 8B is a cross-sectional view of the components of the suction control device 820. Figure 8C and Figure 8D show the suction control device in a retracted position, where Figure 8D is a cross-sectional view of the components of the suction control device 820.

[0073] Referring Figures 8A to 8D , the integrated suction control device 820 and the hemostatic valve 860 can be integrated into a common housing. The integrated device can have an inlet 862 sized to receive and hemostatically seal a catheter 802, an outlet 864 sized to allow an inner elongate member 808 to pass through and hemostatically seal the inner elongate member 808, a side port 866 designed to connect to a vacuum system, a suction control valve 822 in communication with the side port 866, a trigger control engagement portion 840 for operating the control valve 822 to regulate the suction blood flow, a locking brake 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.

[0074] The control valve 822 can be positioned in the flow path extending from the lumen 803 of the guide catheter 802 to the side port 866, and the control valve 822 can adjust the blood flow rate of the suction through the flow path. The trigger control engagement 840 can extend between the joint 850 positioned near the outlet locking actuator 870 and the slotted sleeve 854 around the portion 844 of the housing extending towards the side port 866. The trigger 840 can be bent at the joint 850, and the slotted sleeve 854 can slide along the portion 844 of the housing. The housing portion 844 can define the travel length of the trigger 840 such that when the trigger is bent towards the side port 866, the trigger is in the initial or fully extended position, as shown in Figure 8A and Figure 8B and when the trigger is bent towards the body of the hemostatic valve 860, the trigger is in the final or fully retracted position, as shown in Figure 8C and 8D . When the trigger 840 is not operated, the trigger 840 can be spring-loaded to return to the initial position as shown in Figure 8A and Figure 8B .

[0075] The integrated suction control device / hemostatic valve device can be grasped with one hand, with the thumb positioned on the thumb grip 848 near the outlet locking actuator 870, the index finger positioned on the trigger 840, and the remaining fingers positioned on the device and the guide catheter 802 to stabilize the guide catheter 802. The trigger 840 can be moved from the initial position to the final position by squeezing the index finger towards the thumb.

[0076] Referring to Figure 8B and Figure 8D , the suction control device 820 can include a control valve 822 that includes a compressible tubing 824 having an opening 826 that can move through a range of sizes in response to being compressed or released by a compression element 842 in communication with the trigger 840. The suction control device 820 can be a normally closed device. In the initial position as shown in Figure 8B , the compression element 842 can extend through the opening 846 of the housing 844 to provide maximum compression to the compressible tubing 824. When the trigger 840 is moved from the initial position indicated by the arrow, the slotted sleeve 854 can move on the housing portion 844. When the slotted sleeve 854 is moved away from the side port 866, the compression element 842 can move into the groove 855 in the slotted sleeve 854, as shown in Figure 8DAs shown. The compression element 842 can be spring-loaded, or the compression element 842 can freely slide through the opening 846 of the housing 844 and move into the groove 855 due to elastic recovery, stretching the compressible tubing 824 and pressing the compression element 842. As the compression element 842 moves into the groove 855, the compressible tubing 824 can stretch to allow a greater flow rate through the control valve 822.

[0077] The groove 855 can be angled such that as the grooved sleeve 854 moves along the housing portion 844, it moves away from the side port 866 and travels from the initial position as shown Figure 8B to the retracted position as shown Figure 8D in. The compression element 842 can be further gradually moved into the grooved sleeve 854, allowing the opening 826 of the compressible tubing 824 to increase. The size of the opening 826 of the compressible tubing 824 can control the blood flow rate being aspirated. Thus, by holding the trigger 840 at a position between the initial position and the fully retracted position, the user can select a blood flow rate at a continuous blood flow rate. The trigger 840 can be spring-loaded such that it returns to the initial position when not being operated.

[0078] Figures 9A to 9C FIG. is a diagram of an exemplary system 900 including a suction control device 920 having a two-finger gripping engagement 940 integrated with a hemostatic valve 960. Figure 9B and Figure 9C are Figure 9A cross-sectional views of the components of the suction control device 920 as shown in, where Figure 9A and Figure 9B show the suction control device 920 in the initial position, and Figure 9C show the suction control device 920 in the retracted position.

[0079] Referring Figures 9A to 9C , the suction control device 920 and the hemostatic valve 960 can be integrated into a common housing. The integrated device can have an inlet 962 sized to receive and hemostatically seal a catheter 902, an outlet 964 sized to allow an internal elongate member 908 to pass through and hemostatically seal the internal 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 gripping engagement 940 for operating the control valve 922 to regulate the aspirated blood flow, a locking brake 970 positioned at the outlet 964 and having a hemostatic seal, and a hemostatic indicator 972 for indicating the state of the hemostatic seal at the outlet 964.

[0080] The control valve 922 can be positioned in the flow path extending from the lumen 903 of the guide catheter 902 to the side port 966, and the control valve 922 can adjust the blood flow rate of the suction through the flow path. The control junction 940 can have a slotted sleeve 954 around the housing portion 944 of the integrated device near the side port 966. The

[0081] slotted sleeve 954 can slide along the housing portion 944. The housing portion 944 can define the travel length of the trigger 940 such that the trigger is in the initial or fully extended position when the trigger is closest to the side port 966, and the trigger 940 is in the final position or fully retracted position when the trigger is closest to the body of the hemostatic valve 960. The trigger 940 can be spring-loaded to return to the initial position when the trigger 940 is not operated. The trigger 940 can have two arms extending from either side of the slotted sleeve 954.

[0082] The integrated suction control / hemostatic valve device can be grasped with 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 the guide catheter 902 to stabilize the guide catheter 902. The trigger 940 can be moved from the initial position to the final position by squeezing the index finger and the middle finger towards the thumb.

[0083] Referring Figure 9B and Figure 9C , the suction control device 920 can include a control valve 922 that includes a compressible tubing 924 having an opening 926 that is movable through a range of sizes in response to being compressed or released by a compression element 942. The compression element 942 can communicate with the trigger 940 through the slotted sleeve 954. The suction control device 920 can be a normally closed device. In the initial position as shown in Figure 9B , the compression element 942 can extend through the opening 946 of the housing 944 to provide maximum compression to the compressible tubing 924. When the trigger 940 is moved from the initial position as indicated by the arrow in Figure 9C , the slotted sleeve 954 can move on a portion of the housing 944 and away from the side port 966. When the slotted sleeve 954 is moved away from the side port 966, the compression element 942 can move into the groove 955 in the slotted sleeve 954.

[0084] The compression element 942 can be spring-loaded, or the compression element 942 can freely slide through the opening 946 of the housing 944 and move into the groove 955 due to elastic recovery, stretching the compressible tubing 924 and pressing the compression element 942. As the compression element 942 moves into the groove 955, the compression tube 924 can stretch to allow a greater flow rate through the control valve 922. The groove 955 can be angled such that as the grooved sleeve 954 moves along the housing portion 944 and moves away from the side port 966 as indicated by the arrow, the compression element 942 can further gradually move into the grooved sleeve 954, thereby allowing the opening 926 of the compressible tubing 924 to increase. The size of the opening 926 of the compressible tubing 924 can control the blood flow rate being aspirated. Thus, by holding the trigger 940 in a position between the initial position and the fully retracted position, the user can select a blood flow rate from a continuous range of blood flow rates. The trigger 940 can be spring-loaded such that it returns to the initial position when not being operated.

[0085] Figures 10A to 10C FIG. is a diagram of an exemplary system 1000 that includes a suction control device 1020 having a rod engagement portion 1040 integrated into a hemostatic valve 1060, Figure 10A showing the rod engagement portion 1040 in an initial position, Figure 10B showing the rod engagement portion 1040 in a retracted position, and Figure 10C showing Figure 10B a cross-sectional view of. Referring Figures 10A to 10C , the suction control device 1020 and the hemostatic valve 1060 can be integrated into a common housing. The integrated device can have an inlet 1062 sized to receive and hemostatically seal a catheter 1002, an outlet 1064 sized to allow an internal elongate member 1008 to pass through and hemostatically seal the internal 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 rotary rod engagement portion 1040 for operating the control valve 1022 to regulate the aspirated blood flow, a locking brake 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.

[0086] The control valve 1022 can include a flexible tubing 1024 that is positioned to extend through a bend joint 1050 in the integrated device housing. The bend joint 1050 can be positioned between the body of the hemostatic valve 1060 and the side port 1066. The housing can be bent at the joint 1050, causing the flexible tubing 1024 to bend. As the flexible tubing 1024 bends, the size of the opening 1026 of the tubing 1024 can be adjusted.

[0087] The control valve 1022 can be positioned in the flow path extending from the lumen 1003 of the guiding catheter 1002 to the side port 1066, and the control valve 1022 can adjust the blood flow rate of the aspiration through the flow path. The rod 1040 portion of the aspiration control device 1020 can be bent at the joint 1050 from the initial position or fully extended position as shown in Figure 10A to the fully retracted position as shown in Figure 10B . The aspiration control device 1020 can include a spring 1032 that is positioned to return the rod 1040 to the initial position when the trigger 1040 is not operated.

[0088] The integrated aspiration control device / haemostatic valve device can be grasped with one hand, with the thumb positioned on the thumb grip 1048 near the outlet locking actuator 1070, the index finger positioned on the rod 1040, and the remaining fingers positioned on the device and the guiding catheter 1002 to stabilize the guiding catheter 1002. The rod 1040 can be moved from the initial position to the final position by squeezing the index finger towards the thumb.

[0089] Referring to Figure 10A and Figure 10C shown in, the flexible tubing 1024 can have an opening 1026 that moves through a dimensional range in response to the bending of the flexible tubing 1024 when the rod 1040 moves. The aspiration control device 1020 can be a normally open device. In the initial position, the flexible tubing 1024 can be substantially straight, as shown in Figure 10A . When the flexible tubing 1024 is substantially straight and the rod is in the initial position 1040, the opening 1026 can be at its maximum size (widest opening). In such a configuration, in the initial position, the aspiration control device 1020 can allow the maximum blood flow. When the rod 1040 moves from the initial position in the direction indicated by the arrow in Figure 10A , the bending of the flexible tubing 1024 can cause the opening 1026 to contract, as shown in Figure 10C , thereby restricting the blood flow. Thus, by holding the rod 1040 at a position between the initial position and the fully retracted position, the user can select the blood flow rate at a continuous blood flow rate. As the rod 1040 is released, the rod 1040 can return to the initial position by the spring 1032.

[0090] Figures 11A to 11F Illustrated is an exemplary system 1100, 1100a, which includes an aspiration control device 1120 having a thumb trigger 1140 integrated into a haemostatic valve 1160. Figure 11A and Figure 11B show a system with a freely sliding thumb trigger 1140, while Figures 11C to 11FA system with a thumb trigger 1140a is shown, which can install a ratchet at one or more predetermined positions and be held in place until the ratchet is released. Figure 11A , 11C and 11D show the thumb triggers 1140, 1140a of each respective exemplary system 1100, 1100a in an initial position, Figure 11B , 11E and 11F show the thumb triggers 1140, 1140a of each respective exemplary system 1100, 1100a in a compressed position. Figure 11D For showing a cross-sectional view of the compression element 1142 and the control valve 1122 positioned as shown in Figure 11C . Figure 11F For showing a cross-sectional view of the compression element 1142 and the control valve 1122 positioned as shown in Figure 11E . Referring to 11A to Figure 11F , each respective integrated suction control device 1120, 1120a and hemostatic valve 1160 can be integrated into a common housing. Each integrated device can have an inlet 1162 sized to receive and hermetically seal a catheter 1102 for hemostasis, an outlet 1164 sized to allow an internal elongate member 1108 to pass through and hermetically seal the internal 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 thumb trigger engagement portion 1140, 1140a for operating the control valve 1122 to regulate the suction blood flow, and a locking actuator 1170 positioned at the outlet 1164.

[0091] In addition to the common features of the exemplary systems 1100, 1100a, Figure 11A and Figure 11B the exemplary system 1100 shown in Figure 11C and 11F also includes a suction blood flow indicator 1152 for indicating the blood flow rate through the control valve 1122 and a hemostasis indicator 1172 for indicating the state of the hemostatic seal at the outlet 1164, and Figure 11C and 11F the exemplary system 1100a shown in

[0092] Referring to Figure 11A and Figure 11B the exemplary system 1100 shown in, the thumb trigger 1140 can move from the initial position shown in Figure 11A to the compressed configuration shown in Figure 11B . The thumb trigger 1140 can be spring-loaded to return to the initial position when the trigger 1140 is not operated. Referring to 11C andFigure 11D In the exemplary system 1100a shown, the thumb trigger 1140a can move from an initial position as shown in Figure 11C to a compressed configuration as shown in Figure 11D . The thumb trigger 1140a can be spring-loaded by a spring 1132. The thumb trigger 1140a can be fitted with a ratchet such that it remains in a fully or partially retracted position. A user can press on the thumb trigger 1140a to further retract the thumb trigger 1140a, as shown by the arrow in Figure 11D , and the user can return the thumb trigger 1140a to the initial position by pressing on the ratchet release lever 1143, as shown by the arrow in Figure 11C , thereby releasing the ratchet engagement 1153 and returning the spring 1132 to the thumb trigger 1140a.

[0093] In either exemplary system 1100, 1100a, the integrated aspiration control / hemostasis valve device can be grasped with one hand, with the thumb positioned on the thumb trigger 1140, 1140a and the fingers positioned on the housing of the integrated device and the guide catheter 1102 to steady the device and the guide catheter 1102 and provide a lever action for compressing the thumb trigger 1140, 1140a. The index finger can be positioned near the side port 1166 and the little finger can be positioned on the guide catheter 1102. By squeezing the thumb towards the fingers, as indicated by the arrow in Figure 11B or 11D, the thumb trigger 1140, 1140a can be moved from the initial position as shown in Figure 11A or 11C to the compressed position as shown in Figure 11B or 11D.

[0094] Referring to 11A to Figure 11F, in any system 1100, 1100a, the control valve 1122 can be positioned in the flow path extending from the lumen 1103 of the guide catheter 1102 to the side port 1166, and the control valve 1022 can adjust the blood flow rate of the aspirated blood through the flow path. The control valve 1122 can include a compressible tubing 1124 that is positioned to extend through the housing portion 1144 of the device, which extends from near the inlet 1162 of the hemostatic valve 160 to near the side port 1166. The housing portion 1144 can have an opening 1146 through which the compression element 1142 can pass to compress the compressible tubing 1124. The compression element 1142 can 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, squeezing the compressible tubing 1124 and compressing the compressible tubing 1124. As the compressible tubing 1124 is compressed, the opening 1126 of the tubing 1124 can be restricted to reduce the blood flow rate through the control valve 1122. The opening 1126 can move through a range of sizes in response to being compressed or released by the compression element 1142.

[0095] Reference 11A to Figure 11F , in any system 1100, 1100a, the aspiration control device 1120 can be a normally open device. In the initial position, the compression element 1142 can be positioned outside the opening 1146 of the housing portion 1144, and the compressible tubing 1124 can be uncompressed. In the initial position, the opening 1126 of the compressible tubing 1124 can have a maximum size, which has a wide opening sized to allow a maximum blood flow rate. When the thumb trigger 1140 moves from the initial position shown in 11B or Figure 11D in the direction indicated by the arrow in Figure 11A or Figure 11C as shown in the middle, the compression element 1142 can pass through the opening 1146 of the housing portion 1144 that houses the compressible tubing 1124 and engage the compressible tubing 1124. When the compression element 1142 squeezes the compressible tubing 1124, the opening 1126 of the compressible tubing 1124 can collapse to restrict blood flow through the control valve 1122. When the compression element releases the compressible tubing 1124 or moves towards the initial position, the opening 1126 of the compressible tubing 1124 can expand due to the elastic recovery within the tubing squeezing the tubing open and / or the elastic quality of the material of the compressible tubing 1124.

[0096] Refer to 11A and Figure 11BIn the system 1100 shown, the thumb trigger 1140 and the compression element 1142 can be integrated into a specially molded component 1156, and the component 1156 can be attached to a common housing integrating a suction control device and a hemostatic valve. The compression element 1142 can be fixed relative to the thumb trigger 1140, which means that when the physician engages the thumb trigger 1140, the compression element 1142 is translated by the same distance as the thumb trigger 1140. The component 1156 can pass through a second part 1158 of the housing. The size of the second part 1158 can be set to stabilize the component 1156 relative to the entire device.

[0097] Referring Figures 11C to 11F In the system 1100a shown, the thumb trigger 1140a, the ratchet release lever 1143, a notch forming part of the ratchet engagement 1153, and the compression element 1142 can be integrated into a single molded component 1156a, and the component 1156a can be attached to a common housing integrating a suction control device and a hemostatic valve. Similar to Figure 11A and Figure 11B that shown, the compression element 1142 of the system 1100a can be fixed relative to the thumb trigger 1140a, which means that the compression element 1142 is translated by the same distance as the thumb trigger 1140a. The component 1156a can be around a second part 1158a of the housing. The size of the second part 1158a can be set to stabilize the component 1156a relative to the entire device.

[0098] Although the systems 1100 and 1100a have similar designs in many respects, the use of each design can be significantly different. For Figure 11A and Figure 11B the system 1100 shown, the user can control the position of the thumb trigger 1140 by squeezing and holding the thumb trigger, thereby controlling the flow rate through the suction control device 1120. To utilize Figure 11A and Figure 11B the system 1100 shown to select the flow rate, the user must apply a force to the thumb trigger 1140a (except for the maximum flow rate when the valve opening 1126 is fully open). For Figures 11C to 11F the system 1100a shown, the user can control the flow rate by pressing the thumb trigger 1140a or by pressing the ratchet release lever 1143. Once the user has selected the flow rate using Figures 11C to 11F the system 1100a shown, 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 can be held by the ratchet engagement 1153, and the user does not need to apply any force to hold the position of the trigger 1140a.

[0099] Figure 12FIG. 1200 is a diagram of an exemplary system 1200 that includes a suction control device 1220 having a side grip engagement portion 1240 integrated into a hemostatic valve 1260. The side grip engagement portion 1240 may include a button that can be depressed to vary the flow rate of aspirated blood through the suction control device 1220. A catheter 1202 may be received by an inlet 1262 of the hemostatic valve 1260, and the suction control device 1220 may be positioned in the flow path from the catheter 1202 to a side port 1266 of the hemostatic valve 1260. The side port 1266 may be sized to connect to a vacuum system such as a vacuum pump or syringe. The suction control device 1220 may have an internal valve having an opening that can be adjusted by depressing the side grip 1240. The suction control device 1220 may be positioned such that a physician can adjust the flow rate through the flow path having the side grip 1240 while stabilizing the guide catheter 1202 and withdrawing a pull wire or other internal elongate member from an outlet 1264 of the hemostatic valve 1260.

[0100] The side grip 1240 may be compressible as a binary switch to toggle between a maximum blood flow rate and a minimum blood flow rate. As an alternative, the side grip 1240 may be clicked through a flow rate sequence, with each click selecting a progressively larger or smaller flow rate, resetting the clicks to end and then returning the flow rate to the starting flow rate. As an alternative, the side grip 1240 may adjust the flow rate at continuous flow rates in response to a force applied to the side grip, where the flow rate may be directly or negatively correlated with the force. In either configuration, the suction control device 1220 may be a normally open or normally closed device.

[0101] Figures 13A to 13E FIG. 1201 is a diagram of a blood flow indicator that may be used to indicate blood flow through a suction control device. Figures 13A to 13E The blood flow indicator shown in FIG. 1201 may be placed in the flow path of a control valve that includes the suction control device. Some specific exemplary suction control devices 120, 420, 1120 disclosed herein include blood flow indicators 152, 452, 1152 (see FIGS. 11A and 11B), and these blood flow indicators 152, 452, 1152 may be designed as shown in FIG. 1201 or other designs having a similar function. It is contemplated that other examples disclosed herein may also include blood flow indicators such as the blood flow indicator shown in FIG. 1202 or other designs having a similar function. Figure 1 、 4 、11A and 11B), and these blood flow indicators 152, 452, 1152 may be designed as shown in FIG. 1201 or other designs having a similar function. It is contemplated that other examples disclosed herein may also include blood flow indicators such as the blood flow indicator shown in FIG. 1202 or other designs having a similar function. Figures 13A to 13E FIG. 1201 or other designs having a similar function. It is contemplated that visual indication of blood flow may be achieved by providing a transparent material along the blood flow path such that a physician or user can see the blood in the channel. Figures 13A to 13E FIG. 1202 or other designs having a similar function.

[0102] It is contemplated that visual indication of blood flow may be achieved by providing a transparent material along the blood flow path such that a physician or user can see the blood in the channel. Figure 13AA pinwheel flow rate indicator is shown that can be positioned within a flow path and encapsulated by a transparent material. In addition to a physician seeing the presence of blood in the flow path, the pinwheel can be seen through the transparent material along the blood flow path. The pinwheel can rotate faster as the blood flow rate increases, and the rotational speed of the pinwheel can provide a visual indication of the blood flow rate to the physician. As an alternative, the blood does not have to be visible as long as at least a portion of the pinwheel is visible, and that portion moves as a visual indication of the blood flow rate.

[0103] Figure 13B and Figure 13C A rotating flange cylinder flow rate indicator is shown that can be positioned within a flow path and encapsulated by a transparent material. The top of the flange of the flow rate indicator can be seen through the transparent material along the blood flow path. As the blood flow rate increases, the cylinder can rotate faster, and the speed of the top of the flange can provide a visual indication of the blood flow rate to the physician. As an alternative, the blood does not have to be visible as long as at least a portion of the flow rate indicator is visible, and that portion moves as a visual indication of the blood flow rate.

[0104] Figure 13D and Figure 13E A rotating stripe band is shown having inclined vanes extending from the inner circumference of the band to a central node. The vanes can be positioned along the blood flow path, and as blood flows over the angled vanes, the indicator can circumferentially rotate at a rotational speed determined by the blood flow rate. The striped perimeter of the band can be seen by the physician, and the rotational speed of the band can provide a visual indication of the flow rate. The band can be visible by being positioned within a transparent housing or by being positioned to be visible through an opening in an opaque housing.

[0105] Figure 14A A diagram of an exemplary system 1400 including a suction control device 1420 controlled by a button engagement portion 1440, the suction control device 1420 being integrated with a hemostatic valve 1460 in a common housing. Figures 14B to 14D A diagram of various aspects and configurations of the suction control device 1420.

[0106] The button engagement portion 1440 may include a button that can be compressed to vary the flow rate of aspirated blood through the aspiration control device 1420. The catheter 1402 may be received by the inlet 1462 of the hemostatic valve 1460, and the aspiration control device 1420 may be positioned in the flow path from the catheter 1402 to the side port 1466 of the hemostatic valve 1460. The size of the side port 1466 may be sized to connect to a vacuum system such as a vacuum pump or syringe. The aspiration control device 1420 may have an internal valve that can be adjusted by pressing the side grip 1440. The button engagement portion 1420 may be positioned such that a physician can use the button 1440 to adjust the flow rate through the flow path while stabilizing the guide catheter 1402 and removing a pull wire or other internal elongate member from the outlet 1464 of the hemostatic valve 1460.

[0107] As Figure 14B shown, the aspiration control device 1420 may include compressible tubing 1424, a housing 1444, a button 1440, and a spring 1432. The compressible tubing 1424 may act as a valve 1422 having an opening 1426 that varies in size in response to a force applied to press the button 1440 by continuous sizing. The housing 1444 may accommodate the compressible tubing 1424. The button 1440 may be mounted in an opening 1446 of the housing 1444 and attached to the housing 1432 by one or more springs 1444. The aspiration control device 1420 may be a normally open device, and Figure 14B the aspiration control device 1420 may be shown in an initial open position. In the initial position, the compressible tubing 1424 may have an opening 1426 that is open to allow maximum blood flow. The button 1440 may be pressed to compress the compressible tubing 1424. The aspiration control device 1420 may include a compression element 1442 that is positioned to squeeze the compressible tubing 1424 when the button 1440 is pressed to adjust the size of the opening 1426. When the button 1440 is not operated, the spring 1432 may provide a spring force to return the aspiration control device 1420 to the initial position. For a normally open configuration, the flow rate may be inversely proportional to the force applied to the button.

[0108] Figure 14C A variation in the configuration of the spring 1432 relative to Figure 14B the aspiration control device 1420 described above is shown.

[0109] As Figure 14DAs shown, the aspiration 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 tubing 1424 when the button 1440 is not operated. A force applied to the button 1440 can move the compression element 1442 to allow the opening 1426 of the compressible tubing 1424 to expand to increase blood flow rate. For a normally closed configuration, the flow rate can be directly related to the force applied to the button 1440.

[0110] Figure 15 FIG. is an illustration of an exemplary system 1500 that includes an aspiration control device 1520 integrated with a hemostatic valve 1560. The integrated aspiration control device 1520 and hemostatic valve 1560 can be integrated into a common housing. The integrated device can have an inlet 1562 sized to receive and hemostatically seal a catheter 1502, an outlet 1564 sized to allow an internal elongate member to pass through and hemostatically seal the internal 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 control engagement 1540 for operating the control valve to regulate the blood flow of the aspiration. The control valve can be positioned in the flow path extending from the lumen of the catheter 1502 to the side port 1566, and the control valve can regulate the blood flow rate of the aspiration through the flow path. The switch engagement 1540 can include a lever that can rotate about a joint 1550 connected to the device housing. The control valve can have an opening that adjusts in size as the lever of the switch engagement 1540 rotates about the joint 1550, thereby regulating the blood flow rate of the aspiration. The lever of the switch engagement 1540 can be spring-loaded such that it returns to a default position when not operated. Alternatively, the switch engagement 1540 can hold the position it most recently moved to when not operated.

[0111] Figure 16 FIG. is an illustration of an exemplary system 1600 that includes two aspiration control devices 1620, 1621 configured to regulate aspiration at two hemostatic valves 1660, 1680 having a single vacuum source through two catheters 1602, 1604. The system 1600 can provide aspiration to the two catheters 1602, 1604 simultaneously from a single vacuum source. The aspiration control devices 1620, 1621 can provide control such that the aspiration provided to each of the catheters 1602, 1604 simultaneously is different from each other.

[0112] The system 1600 may include a first hemostatic valve 1660 having an inlet 1662 sized to receive and hemostatically seal a guide catheter 1602, an outlet 1664 sized to permit passage of an 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 aspiration control device 1620 positioned to regulate blood flow through a flow path from the lumen of the guide catheter 1602 to the first side port 1666 of the hemostatic valve 1660. The first aspiration control device 1620 may be integrated with the first hemostatic valve 1660 in a common housing. The first side port 1666 may be connected to a vacuum source. The second side port 1668 may be connected to a tubing 1616. The first hemostatic valve 1660 may include an outlet locking actuator 1670 for engaging and sealing the intermediate catheter 1604.

[0113] The system 1600 may include a second hemostatic valve 1680 having an inlet 1682 positioned to receive the intermediate catheter 1604 and hemostatically seal the intermediate catheter 1604, an outlet 1684 sized to permit passage of an internal elongate member 1608 such as a pull wire or shaft of a thrombectomy device and hemostatically seal the internal elongate member 1608, and a third side port 1686. The system may include a second aspiration control device 1621 positioned to regulate blood flow through a flow path from the lumen of the intermediate catheter 1604 to the third side port 1686. The second aspiration control device 1621 may be a separate component connectable to the third side port 1686. Alternatively, the second aspiration control device 1621 may be integrated with the second hemostatic valve 1680. The third side port 1686 may be sized to connect to the second aspiration control device 1621, and the second aspiration control device 1621 may be connected to the tubing 1616.

[0114] System 1600 may include two flow paths to provide aspiration to each catheter 1602, 1604 simultaneously. The two flow paths may converge in a control valve of a first aspiration control device 1620 and receive vacuum pressure from a vacuum source connected to a first side port 1666 of a first hemostatic valve 1660. The first flow path may extend from the 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 a side port 1686 (third side port) of the second hemostatic valve 1680, through a second control valve of a second aspiration control device 1621, through tubing 1616, through a second side port 1668 of the first hemostatic valve 1660, through the control valve of the first aspiration control device 1620, and extend to the second side port 1666 of the first hemostatic valve 1660. Since the first and second flow paths converge in the control valve of the aspiration 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 aspiration control device 1621 may be operable 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.

[0115] This arrangement may be particularly advantageous in thrombectomy procedures when the intermediate catheter 1604 is used in combination with a guide catheter or sheath 1602. The second hemostatic valve 1660 with the aspiration control device 1621 may be connected to the intermediate catheter 1604, and the extension tubing 1616 may connect the aspiration flow to the first hemostatic valve 1660 connected to the guide catheter or sheath 1602. A single vacuum source connected to the aspiration control valve 1666 may urge reverse flow through the guide catheter 1602 and the intermediate catheter 1604 as the extension tubing is retracted, and the vacuum source is particularly important for preventing clot embolism as the tip of the intermediate catheter 1604 enters the tip of the guide catheter 1602. This may also be very advantageous if a stentriever is used in combination with the intermediate catheter 1604 and the guide catheter 1602, especially when the stentriever is partially withdrawn into the intermediate catheter 1604 and the stentriever and the intermediate catheter 1604 are withdrawn as a single unit such as during the EPIC technique as a single unit. For ease of this operation, the vacuum extension tubing 1616 may have a greater length than the intermediate catheter and may be coiled or extensible for ease of handling. In some thrombectomy procedures, the first hemostatic valve 1660 may be a standard hemostatic valve and may not need to include an additional aspiration control device 1620.

[0116] The first aspiration control device 1620 and the second aspiration control device 1621 may be designed in accordance with the examples and principles disclosed herein and need not be specifically designed as shown in Figure 16 as shown.

[0117] Figure 17 FIG. is a diagram of an exemplary system 1700 that includes a suction control device 1720 having an electric actuator. As shown, the suction control device 1720 can be integrated into a hemostatic valve 1760. The integrated suction control device 1720 and the hemostatic valve 1760 can be integrated into a common housing. The integrated device can have an inlet 1762 sized to receive and hermetically seal a catheter 1702 for hemostasis, an outlet 1764 sized to allow an inner elongate member 1708 to pass through and hermetically seal the inner elongate member 1708, a side port 1766 designed to connect to a vacuum system, a suction control valve in communication with the side port 1766, and a control interface 1740 for operating the control valve to regulate the suction blood flow. The control valve can be positioned in a flow path extending from the lumen of the catheter 1702 to the side port 1766, and the control valve can regulate the blood flow rate of the suction through the flow path. Although not shown, it is contemplated that an external suction control device 120 as shown in FIG. may include an electrical interface. Figure 1 The control valve can have an opening sized depending on an electric mechanism such as a motor. The electric actuator can be programmed to have a predetermined sequence of a set of flow rates and / or valve open positions that a physician can select via the interface 1740. When the electric actuator is activated, the opening of the control valve can be sized based on the selected program.

[0118] In some examples, the program can include a specific waveform or flow pattern. In some applications, it is advantageous to increase the likelihood that the catheter can fully aspirate a clot by a pulsating or varying vacuum rate, or if the clot has a high fibrin content and cannot be fully aspirated, the pulsating vacuum can give the catheter an improved grip on the clot. This can be beneficial when using the suction control valve with a balloon guide catheter, a guiding sheath, an intermediate catheter, or other catheters for thrombectomy procedures.

[0119] The control interface 1740 can include mechanisms for selecting a program for the electric actuator and activating the electric actuator to execute the program. The interface 1740 includes a mechanical input that can be operated by a physician to activate the electric actuator such as a slider, a button, a switch, a wheel, a trigger, a grip, a lever, a rotary valve, a handle, and / or other mechanisms such as those described for a mechanically controlled suction control valve. Additionally or alternatively, the interface 1740 can include a touch screen, a touch pad, a plurality of buttons, a text and / or video display, or other types of electronic device user interfaces.

[0120]

[0121] Figures 18 to 20 Figure 21 FIGS. are flowcharts each including method steps for controlling suction during endovascular treatment. Figure 21A flowchart including method steps for clot retrieval treatment. The method steps can be implemented by any of the exemplary systems, devices, and / or equipment described herein or by means known to those of ordinary skill in the art. The method steps of one or more of methods 1800, 1900, 2000, 2100 can be combined.

[0122] Refer to Figure 18 In method 1800 shown in, at step 1808, a hemostatic valve having a distal port and a side port can be provided. At step 1816, a suction control device having a control valve and a control engagement portion can be provided. At step 1824, the suction control device can be positioned near the side port. At step 1832, the hemostatic valve and the control valve can be disposed in a common housing. At step 1840, a catheter can be provided. At step 1848, the catheter can be positioned in the distal port of the hemostatic valve. At step 1856, a vacuum source can be provided. At step 1864, the vacuum source can be attached to the side port. At step 1872, a flow path extending from the lumen of the catheter to the side port can be provided. At step 1880, the control engagement portion can be operated to control the flow rate through the flow path. At step 1888, the catheter can be stabilized, and the control engagement portion can be operated with one hand simultaneously.

[0123] Refer to Figure 19 In method 1900 shown in, at step 1910, the control valve of the suction control device can be positioned in the flow path. At step 1920, a flexible tubing having an opening can be positioned in the flow path. At step 1930, a housing having an opening can be provided. At step 1940, the flexible tubing can be positioned in the housing. At step 1950, a compression element in communication with the control engagement portion can be provided. At step 1960, the compression element can be positioned to engage the flexible tubing. At step 1970, the compression element can be positioned in the opening of the housing. At step 1980, by operating the control engagement portion, the compression element can be moved to adjust the size of the opening of the flexible tubing.

[0124] Refer to Figure 20 In method 2000 shown in, at step 2010, the control engagement portion can be moved from an initial position by applying a force to the control engagement portion. At step 2020, the control engagement portion can be released. At step 2030, the control engagement portion can be returned to the initial position.

[0125] Refer to Figure 21For the method 2100 shown, some or all of these 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 and their variants and systems with equivalent functions, together with a balloon guiding catheter, a microcatheter, and a clot retrieval device, to remove a clot from the neurovascular system.

[0126] In step 2102, the balloon guiding catheter may be positioned within the patient. The balloon guiding catheter may be positioned through known procedures, such as first positioning a guide wire within the patient and then advancing the balloon guiding catheter through a suitable guide wire and dilator or access catheter into the patient, followed by removal of the guide wire and access catheter. The balloon guiding catheter may have an inflatable balloon near its distal end, which may be inflated during thrombectomy to inhibit proximal blood flow. The balloon guiding catheter may have a lumen for receiving one or more catheters and / or other devices as needed. The distal end of the balloon guiding catheter may be positioned within the internal carotid artery or near the clot proximal to the clot.

[0127] In step 2104, the balloon guiding catheter may be attached to the inlet of a hemostatic valve. The hemostatic valve may be one of the exemplary hemostatic valves described and shown herein, its variants, or a hemostatic valve with equivalent function.

[0128] In step 2106, the microcatheter and the clot retrieval device may be positioned for treatment. The microcatheter may be positioned such that the distal portion of the microcatheter passes through the clot, most of the length of the microcatheter passes through the balloon guiding catheter, the microcatheter passes through the inlet of the hemostatic valve, and the proximal end of the microcatheter is positioned within the hemostatic valve. While positioning the microcatheter, the valve at the inlet of the hemostatic valve may be fully opened. After positioning the microcatheter on the clot using standard interventional techniques, the clot retrieval device may be introduced through the microcatheter. The clot retrieval device may be configured such that an enlarged portion within the clot is positioned within the portion of the microcatheter located within the clot. When the clot retrieval device is placed into the microcatheter, the valve at the inlet of the hemostatic valve may be locked to the microcatheter.

[0129] In step 2108, the clot retrieval device may be deployed. To deploy the clot retrieval device, the microcatheter may be retracted such that the distal end of the microcatheter is proximal to the clot while maintaining the clot retrieval device in its position within the clot. In this way, the clot retrieval device may not be covered and may expand within the clot once it is detached from the sheath. When retracting the microcatheter, the valve at the inlet of the hemostatic valve may be locked to an intermediate position around the microcatheter to minimize blood loss.

[0130] In step 2110, the suction control valve at the side port of the hemostatic valve can be closed. The suction control valve can be integral with the hemostatic valve or can be attached to the side port as described and shown in the examples herein, its variations, or a suction control valve with equivalent functionality.

[0131] In step 2112, a vacuum can be created at the side port. The vacuum can be created by attaching a screw-on syringe to the side port and retracting its plunger, or by connecting a vacuum pump or other device. The closed suction control valve can prevent blood flow through the side port.

[0132] In some procedures, closing the suction control valve and creating a vacuum as described in steps 2110 and 2112, either before any of steps 2102, 2104, 2106, or 2108 or after step 2108, may be advantageous. Physicians can choose the order that makes the system easier to handle according to their own preferences. In any case, it is preferred to close the suction control valve before applying a vacuum at the side port to prevent premature suction.

[0133] In step 2114, the suction control valve can be opened to a low flow position. The suction control valve can be opened by operating a control engagement, actuator, trigger, slider, lever, or other engagement as described and shown in the examples herein, its variations, and a suction control valve with equivalent functionality. Before opening the suction valve, the balloon on the balloon guide catheter can be inflated to block blood flow in the patient's blood vessel.

[0134] When the suction control valve is opened, blood can flow out of the patient's blood vessel and into the balloon guide catheter, thereby pulling the free thrombus into the catheter. As an alternative or in addition, the balloon guide catheter can be configured to occlude the blood vessel to provide reverse blood flow, thereby improving the efficacy of the clot retrieval device in completely separating and retrieving the thrombus in step 2116.

[0135] In step 2118, after the clot retrieval device has been partially retracted (e.g., past the end of the internal carotid artery), the suction control device can be operated to increase the flow rate to a medium flow rate into the syringe, pump, or other vacuum source.

[0136] In step 2021, after the clot retrieval device has been 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.

[0137] In step 2122, when the suction control device is set to allow the highest flow rate, the clot retrieval device can be retracted into the balloon guide catheter. In steps 2118 to 2122, the microcatheter can be retracted together with the clot retrieval device.

[0138] In procedures where an intermediate catheter or distal access catheter is used to aspirate clots without using an additional clot retrieval device, such as in the aspiration thrombectomy with direct aspiration of the clot and immediate removal technique (ADAPT), the exemplary valve systems described herein can be used to control or regulate the vacuum applied to the catheter via a vacuum pump or syringe. The aspiration control valve can be used to provide the physician with an ergonomically simple way to control the aspiration flow while maintaining control of the catheter and without leaving the patient's side to modify the pump settings.

[0139] The description contained herein is an example of an embodiment of the invention and is not intended to limit the scope of the invention in any way. As described herein, the invention contemplates various variations and modifications to systems and devices for aspirating blood flow, including integrating an aspiration control device with other additional therapeutic devices, attaching an aspiration control device to other conventional therapeutic devices, controlling the flow rate through one or more flow paths using one or more aspiration control devices, using control valves of various configurations, using control junctions of various configurations, using various combinations of components to achieve the functions described, using alternative materials to achieve the functions described, combining components of various examples, combining components in various examples that employ known components, and so on. The invention contemplates alternatives to the component parts described herein that have known component parts, including known control valves, control junctions, indicators, and the like. These modifications will be apparent to those skilled in the art to which the invention pertains and are intended to be encompassed within the scope of the following claims.

Claims

1. A system comprising: A hemostatic valve, the hemostatic valve including a side port and an inlet for receiving a catheter; A control valve in communication with the hemostatic valve, the control valve being disposed near the side port and including a compressible tubing, the compressible tubing including an opening that is movable between a first size and a second size, the first size being sized to restrict blood flow aspirated from the catheter at a first flow rate, and the second size being sized to restrict blood flow aspirated from the catheter at a second flow rate; And A control engagement portion in communication with the control valve, the control engagement portion being movable to change the compression of the compressible tubing to thereby move the opening of the compressible tubing from the first size to the second size; Wherein the control valve, the control engagement portion, and the hemostatic valve are attached to a common housing; and Wherein the control engagement portion is configured to be movable along a portion of the housing extending toward the side port to define a travel length of the control engagement portion such that the control engagement portion is in an initial or fully extended position when the control engagement portion is closest to the side port, and the control engagement portion is in a final position or fully retracted position when the control engagement portion is closest to the body of the hemostatic valve.

2. The system according to claim 1, wherein The control valve is positioned to provide a flow path for the aspirated blood, the flow path extending from the catheter through the control valve and to the side port.

3. The system according to claim 1, wherein The control engagement portion is positioned to allow a user to select one of the first flow rate or the second flow rate with one hand while stabilizing the catheter with the same hand.

4. The system according to claim 1, characterized in that, The control engagement portion 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 engagement portion.

5. The system according to claim 1, wherein The opening is movable through sizes that are continuous between the first size and the second size such that the aspirated blood flow can be controlled at continuous flow rates between the first flow rate and the second flow rate.

6. The system according to claim 1, wherein The hemostatic valve further includes: An outlet sized to allow an internal elongate member disposed within the lumen of the catheter to pass through; A seal disposed near the outlet; A locking actuator that is displaceable to open the seal in a first position, semi-open the seal in a second position, and close the seal in a third position; and A hemostasis indicator that is movable to provide a visual indication of the position of the locking actuator.

7. The system according to claim 6, wherein The hemostasis indicator includes a graduated indicator corresponding to a predetermined semi-open position of the locking actuator, wherein in the predetermined semi-open position, the locking actuator is sized to allow the internal elongate member having an inner diameter between 0.017 inches and 0.021 inches to slidably translate through the locking actuator, and wherein in the predetermined semi-open position, the locking actuator is sized to inhibit air from entering the hemostatic valve around the internal elongate member.

8. The system according to any one of claims 1-7, the system further comprising: a distal port sized to receive the catheter; a proximal port sized to allow an inner elongate member to pass therethrough, the inner elongate member being disposed within the lumen of the catheter; a first side port; and a first flow path extending from the lumen of the catheter to the side port; wherein the control valve is 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; and wherein the control engagement portion includes at least two positions corresponding to at least two flow rates of the blood flow through the first flow path.

9. The system according to claim 8, wherein The control engagement portion includes a slide button positioned to allow a user to simultaneously select one of the at least two positions with one hand while stabilizing the catheter with the same hand.

10. The system according to claim 8, wherein, The control engagement portion includes a button movable between the at least two positions due to a force applied to the button, and wherein the button is positioned to allow a user to simultaneously select one of the at least two positions with one hand while stabilizing the catheter with the same hand.

11. The system according to claim 8, wherein Further comprising: a second side port; and a second flow path extending from the second side port to the first side port, wherein the control valve is in communication with the second side port and the first side port, and wherein the control valve is movable to control the blood flow through the second flow path.

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