Suction control valve

Abstract

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

Description

Technical Field

[0001] The present invention generally relates to intravascular medical procedures, and more specifically to regulating the blood flow rate aspirated during thrombectomy.

Background Art

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

[0003] Known hemostatic values ​​may also include a guidewire, microcatheter, intermediate catheter, device shaft, or a passage through which such elongated components can pass. The passage may include a gasket for hemostatic sealing of the outer circumference of the inner elongated component to minimize blood loss and, if necessary, to hold the inner elongated component in position.

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

[0005] In some procedures, physicians may wish to modify the suction rate during the procedure to suit specific aspects of the clinical case. For example, during thrombectomy, a physician may prefer to suction slowly for the initial release of the blood clot, then increase the suction force as the clot approaches the catheter, and then further increase the suction force to its maximum when drawing the clot into the catheter. Increasing suction during clot retrieval can reduce the likelihood of the vessel collapsing due to negative pressure within the vascular structure, and when performed with a syringe, it allows for more effective use of the syringe's fixed volume compared to a continuously applied vacuum. This technique requires simultaneous operation of the syringe or pump, retraction of the thrombectomy device, and stabilization of the catheter, which can be extremely difficult with conventional systems. [Overview of the project] [Problems that the invention aims to solve]

[0006] Therefore, improved methods, devices, and systems are needed to control aspiration during thrombectomy. Similarly, controlling aspiration flow rate is potentially beneficial in other intravascular or medical procedures where aspiration pumps or aspiration syringes are used. [Means for solving the problem]

[0007] An object of the present invention is to provide systems, devices, and methods that satisfy the above-mentioned needs. Generally, an object of the present invention is to provide a suction control device having a suction control valve that is controllable by a switch, button, slider, trigger, grip, lever, rotary wheel, rotary valve, handle, or other interface, which is conveniently positioned and configured to be operated while simultaneously stabilizing the hemostatic valve and catheter with one hand and / or retracting the elongated member with the other hand. The suction control device may be integrated with the hemostatic valve, integrated with a wire grip device, and / or attached in series with the suction flow path to an inlet, outlet, hose, pump, or syringe. A system for aspirating blood flow during intravascular procedures may include a combination of one or more suction control devices, one or more hemostatic valves, one or more wire grip devices, and / or one or more vacuum sources to provide and / or regulate vacuum to one or more catheters.

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

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

[0010] The control interface may be positioned to allow the user to stabilize the catheter with one hand while selecting either a first or second flow rate with the other. The control interface may be a button configured to select at least one of the first or second flow rates based at least partially on the force applied to the control interface. The opening of the control valve may be movable over a continuous dimension between a first and a second dimension so that the flow of aspirated blood is controllable over a continuous flow rate between the first and second flow rates. The control interface may be movable through a continuous position to move the opening of the control valve over a continuous dimension. The control interface may be spring-loaded, set to a default open position or a default closed position, or ratcheted to be set to any provisional position between fully open and fully closed.

[0011] The hemostatic valve may further include an outlet sized to pass through an inner elongated member, a seal disposed near the outlet, a locking actuator displaceable to open, partially open, or close the seal, and a movable hemostatic indicator to provide a visual indication of the position of the locking actuator. The inner elongated member may be disposed within the lumen of the catheter. The locking actuator may be displaceable from a first, second, and third position, each position corresponding to the open, partially open, or closed state of the seal, respectively. The hemostatic indicator may be movable to indicate the current position of the locking actuator. When the locking actuator is in the partially open position, the inner elongated 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 thrombectomy, the inner elongated component may be a microcatheter, and the stent retriever can be retracted to retrieve the blood clot into the catheter when the catheter is under complete vacuum without air leakage through the seal of the locking actuator.

[0012] An exemplary device may include a distal port, a proximal port, a first side port, a first channel, a control valve, and a control interface. The distal port may be sized to receive a catheter. The proximal port may be sized to allow passage of an internal elongated member, which is disposed within the lumen of the catheter. The first channel may extend from the lumen of the catheter to the first side port. A control valve may communicate with the lumen of the catheter and the first side port, and the control valve may be movable to control blood flow through the first channel. A control interface may communicate with the control valve, and the control interface may be movable between at least two positions, the at least two positions corresponding to at least two flow rates of blood flow through the first channel.

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

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

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

[0016] An exemplary method for aspirating blood flow may include some or all of the following steps and variations thereof. The steps are listed in no particular order. A hemostatic valve having a distal port and a side port may be provided. A suction control device having a control valve and a control interface may be provided. The suction control device may be positioned in close proximity to the side port. The hemostatic valve and the suction control valve may be housed in a common housing.

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

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

[0019] The above and further aspects of the present invention are further discussed below with reference to the accompanying drawings, where similar figures in various drawings indicate similar structural elements and features. The drawings are not necessarily to scale, and instead, emphasis is placed on illustrating the principles of the present invention. The figures depict one or more implementations of the device of the present invention, not as limitations but merely as examples. [Figure 1] This is an example of a suction control device connected to a hemostatic valve according to an aspect of the present invention. [Figure 2] An example of a suction control device having a sliding interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 3] An example of a suction control device having a push-button interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 4] An example of a system according to an aspect of the present invention is a system including a suction control device connected to regulate suction in two hemostatic valves. [Figure 5] An example of a system according to an aspect of the present invention, including a suction control device integrated into a wire grip device. [Figure 6A] An example of a suction control device having a trigger, a locking actuator, and a hemostatic indicator, integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 6B]An illustration of a suction control device integrated with a hemostatic valve and having a trigger, a locking actuator, and a hemostasis indicator, according to an aspect of the present invention. [Figure 6C] An illustration of a suction control device integrated with a hemostatic valve and having a trigger, a locking actuator, and a hemostasis indicator, according to an aspect of the present invention. [Figure 7A] An illustration of a locking actuator, according to an aspect of the present invention. [Figure 7B] An illustration of a hemostasis indicator, according to an aspect of the present invention. [Figure 7C] An illustration of a hemostasis indicator, according to an aspect of the present invention. [Figure 7D] An illustration of a hemostasis indicator, according to an aspect of the present invention. [Figure 7E] An illustration of a hemostasis indicator, according to an aspect of the present invention. [Figure 7F] An illustration of a hemostasis indicator, according to an aspect of the present invention. [Figure 7G] An illustration of a hemostasis indicator, according to an aspect of the present invention. [Figure 7H] An illustration of a hemostasis indicator, according to an aspect of the present invention. [Figure 7I] An illustration of a hemostasis indicator, according to an aspect of the present invention. [Figure 8A] An illustration of a suction control device integrated with a hemostatic valve and having a trigger finger grip interface, according to an aspect of the present invention. [Figure 8B] An illustration of a suction control device integrated with a hemostatic valve and having a trigger finger grip interface, according to an aspect of the present invention. [Figure 8C] An illustration of a suction control device integrated with a hemostatic valve and having a trigger finger grip interface, according to an aspect of the present invention. [Figure 8D] An illustration of a suction control device integrated with a hemostatic valve and having a trigger finger grip interface, according to an aspect of the present invention. [Figure 9A]An example of a suction control device having a two-finger grip interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 9B] An example of a suction control device having a two-finger grip interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 9C] An example of a suction control device having a two-finger grip interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 10A] This is an example of a suction control device having a lever interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 10B] This is an example of a suction control device having a lever interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 10C] This is an example of a suction control device having a lever interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 11A] Two examples of modifications of a suction control device having a thumb trigger interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 11B] Two examples of modifications of a suction control device having a thumb trigger interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 11C] Two examples of modifications of a suction control device having a thumb trigger interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 11D] Two examples of modifications of a suction control device having a thumb trigger interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 11E] Two examples of modifications of a suction control device having a thumb trigger interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 11F] Two examples of modifications of a suction control device having a thumb trigger interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 12]An example of a suction control device having a side grip interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 13A] This is an example of a blood flow indicator for a suction control device according to an aspect of the present invention. [Figure 13B] This is an example of a blood flow indicator for a suction control device according to an aspect of the present invention. [Figure 13C] This is an example of a blood flow indicator for a suction control device according to an aspect of the present invention. [Figure 13D] This is an example of a blood flow indicator for a suction control device according to an aspect of the present invention. [Figure 13E] This is an example of a blood flow indicator for a suction control device according to an aspect of the present invention. [Figure 14A] This is an example of a suction control device controlled by a push-button interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 14B] This is an example of a suction control device controlled by a push-button interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 14C] This is an example of a suction control device controlled by a push-button interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 14D] This is an example of a suction control device controlled by a push-button interface integrated into a hemostatic valve, according to an aspect of the present invention. [Figure 15] This is an example of a suction control device controlled by a switch interface according to an aspect of the present invention. [Figure 16] An example of a system comprising two suction control devices configured to regulate suction in two hemostatic valves using only one vacuum source, according to an aspect of the present invention. [Figure 17] This is an example of a suction control device having an electrically operated interface. [Figure 18] This is a flowchart showing each step of a method for controlling aspiration during thrombectomy according to an aspect of the present invention. [Figure 19] This is a flowchart showing each step of a method for controlling aspiration during thrombectomy according to an aspect of the present invention. [Figure 20] This is a flowchart showing each step of a method for controlling aspiration during thrombectomy according to an aspect of the present invention. [Figure 21] This is a flowchart showing each step of a method for controlling aspiration during thrombectomy according to an aspect of the present invention. [Modes for carrying out the invention]

[0020] Examples disclosed herein may generally include suction control devices or devices used in conjunction with hemostatic valves to allow physicians to more easily alter the flow rate of blood aspirated during endovascular procedures compared to some conventional systems. A suction control device may include a control valve in the flow path of blood being aspirated and an interface for moving the control valve to regulate the flow rate through the flow path. Controlling the flow rate at the control valve can control backflow at the procedure site. For example, the flow rate of backflow around a blood clot can be altered during thrombectomy by manipulating the suction control device.

[0021] The suction control device may be positioned in various locations and may have various configurations of control interfaces to achieve greater ease of use compared to conventional systems. For example, the suction control device may be a standalone assembly connectable to the side port of the hemostatic valve, the suction control device and the hemostatic valve may be integrated as a single assembly, or the suction control device may be integrated with a secondary device such as a wire grip device. The interface for moving the control valve may move between two or more distinct positions or across consecutive positions. Similarly, the control valve may be movable between two or more distinct positions or across consecutive positions in response to the positioning of the interface. The regulated flow rate through the control valve may be adjusted by the movement of the control valve. For example, the interface may include mechanical interfaces such as sliders, push buttons, switches, wheels, triggers, grips, levers, rotary valves, and handles, which allow the physician to stabilize the guide catheter or sheath with only one hand while adjusting the flow rate, leaving the physician's second hand free for other activities such as withdrawing the stent retriever and microcatheter. The interface may be designed to function similarly to valves already known to physicians, such as rotary valves, in order to provide a more intuitive interface. In some examples, the suction control device may additionally include an electrical actuator that can be programmed to provide a specific waveform or suction flow pattern.

[0022] Several exemplary systems having a purely mechanical suction control device, and several exemplary systems additionally including an electrical actuator, may be used to switch the vacuum on or off, allowing the vacuum to provide a sudden and significant pressure change in the catheter, which helps to result in improved engagement and removal of stubborn thrombi.

[0023] A control valve may have various orientations for regulating blood flow through the control valve. A control valve may include a section of compressible tubing that can be compressed by operating a suction control device interface. The valve may be in an normally open, uncompressible state when not operated and can be compressed to restrict flow as a result of operating the interface; or the valve may be in a normally closed, compressed state when not operated and can expand to increase flow as a result of operation; or the valve may maintain its final, possibly partially compressed, compressed state when not operated and when moved to different holdable states as a result of operation. For example, a spring-loaded control valve may be designed as a normally open or normally closed valve, and a rotary valve may be designed as a state-holding valve.

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

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

[0026] Figure 1 illustrates an exemplary system 100 including a suction control device 120 and a hemostatic valve 160. Figure 1 illustrates the suction control device 120 as a standalone device that can be connected to a side port 166 of the hemostatic valve 160 and to a tube 112 of the vacuum system. An advantage of the standalone suction control device 120 is that it can be configured to mate with a conventional hemostatic valve 160. A catheter 102 may be received by the inlet 162 of the hemostatic valve 160, and the suction control device 120 may be positioned in a flow path from the catheter 102, through the side port 166 of the hemostatic valve 160, and through the tube 112 to the vacuum system. The suction control device 120 may have an internal valve that can be adjusted by moving a control interface or actuator 140. The suction control device 120 may include a flow indicator 152 for providing a visual indicator of the velocity of blood flow through the suction control device 120. The suction control device 120 can be positioned so that a physician can adjust the flow rate through the channel using the interface 140, while simultaneously stabilizing the guide catheter 102 and withdrawing a pull wire, the shaft of a thrombectomy device, or other internal elongated member 108 from the outlet 164 of the hemostatic valve 160.

[0027] Figure 2 illustrates an exemplary system 200 including a hemostatic valve 260 and an integrated suction control device 220. The integrated suction control device 220 and the hemostatic valve 260 may be integrated into a common housing. The integrated device may have an inlet 262 having a Luer connection to receive and hemostatically seal a catheter 202, an outlet 264 sized to allow passage of an internal elongated member 208 and adjustable to hemostatically seal the internal elongated member 208, a side port 266 designed to connect to a vacuum system, a control interface 240 for operating the control valve to regulate the aspirated blood flow, and a visual indicator 252 providing an indicator of the aspirated blood flow rate. The control valve may be positioned within a flow path extending from the lumen of the catheter 202 to the side port 266, and the control valve may regulate the aspirated blood flow rate through the flow path. The control interface 240 may be a slider button that is movable along the trajectory 241, and the control valve may have an opening that resizes as the slider 240 moves along the trajectory 241, thereby regulating the flow rate of blood aspirated. The slider 240 may be spring-loaded to return to its default position when not being operated. Alternatively, the slider 340 may maintain its most recently moved position when not being operated.

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

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

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

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

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

[0033] The control interface 440 may be a slider button that is movable along the track 441, and the control valve may have an opening that resizes as the slider 440 moves along the track 441, thereby regulating the first and second aspirated blood flows. The slider 440 may be spring-loaded to return to a default position when not being operated. Alternatively, the slider 440 may maintain its most recently moved position when not being operated.

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

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

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

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

[0038] The control interface 540 may be a slider button movable along the trajectory 541, and the control valve may have an opening that resizes as the slider 540 moves along the trajectory 541, thereby regulating the blood flow rate aspirated through the guide catheter 502. The slider 540 may be spring-loaded to return to a default position when not being operated. Alternatively, the slider 540 may maintain its most recently moved position when not being operated.

[0039] In an exemplary embodiment of the system 500 illustrated in Figure 5, a physician can simultaneously control aspiration by operating a control interface 540 while withdrawing a microcatheter 504 and a thrombectomy device shaft 508 from a catheter 502. In the exemplary embodiment, the system may be configured such that the outlet 564 of a first hemostatic valve 560 is in a semi-open position, allowing the microcatheter 504 to slide through the outlet 564 while preventing air leakage; the microcatheter 504 may be locked in place at the inlet of a second hemostatic valve 580 so as to prevent the microcatheter 504 from moving toward the second hemostatic valve 580; the outlet 584 of the second hemostatic valve 580 may be locked around the stent leaver device shaft 508 so as to prevent the shaft 508 from moving toward the second hemostatic valve 580 and the microcatheter 504; and a wire grip device 590 may be locked to the shaft 508 so as to prevent the shaft 508 from moving toward the grip device 590. With this configuration, the wire grip device 590 is moved proximal to the first hemostatic valve 560, thereby pulling the stent rever shaft 508, the second hemostatic valve 580, and the microcatheter 504 proximal, allowing the microcatheter 504 and the device 508 to be drawn out from the guide catheter 502. The physician can use one hand to stabilize the first hemostatic valve 560 while simultaneously using the other hand to pull the wire grip device 590 and operate the control interface 540 on the wire grip device 590.

[0040] Figure 6A illustrates an exemplary system 600, including a suction control device 620 having a trigger control interface 640 integrated with a hemostatic valve 660. Figures 6B and 6C are cross-sectional views of the suction control device 620 shown in Figure 6A, with Figure 6B illustrating the control interface 640 in its initial position and Figure 6C illustrating the control interface 640 in its retracted position. Referring together to Figures 6A and 6C, the integrated suction control device 620 and the hemostatic valve 660 can be integrated into a common housing. The integrated device may include an inlet 662 sized to receive and hemostatically seal a catheter 602, an outlet 664 sized to allow passage of an internal elongated member 608 and hemostatically seal the internal elongated member 608, a side port 666 designed to connect to a vacuum system, a suction control valve 622 communicating with the side port 666, a trigger control interface 640 for operating the control valve 622 to regulate the aspirated blood flow, a locking actuator 670 positioned at the outlet 664, and a hemostatic indicator 672 for indicating the state of hemostatic sealing at the outlet 664.

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

[0042] 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 its initial position to a retracted position by gripping the index finger toward the thumb.

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

[0044] Figure 6B illustrates the control interface 640 in its initial position. In the initial position, the compression element 642 extends through the opening 646 in the housing 644 to provide maximum compression to the compressible tube 624. As the trigger 640 moves from the initial position, as indicated by the larger arrow, the compression element 642 engages with the edge of the opening 646 in the housing 644 and may bend away from the compressible tube 624, as indicated by the smaller arrow.

[0045] Figure 6C illustrates the control interface 640 in a retracted position, where the compression element 642 is bent so that it moves out of the opening 646 in the housing 644 as a result of the trigger being squeezed away from the side port 666. When the compression element 642 is bent away from the compressible tube 624, the opening 626 in the compressible tube 624 may widen to allow a greater flow through the control valve 622.

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

[0047] Figure 7A illustrates an exemplary locking actuator 770 and an exemplary hemostatic indicator 772a that can be positioned at the outlet 764 of the hemostatic valve. The locking actuator 770 can be tightened by operating a rotary thumb wheel or by pressing a push button. The locking actuator 770 may include a gasket or other seal that can be tightened onto a catheter, pull wire, or other elongated member extending through the outlet 764 of the hemostatic valve. The locking actuator 770 may allow the elongated member to retract from the outlet 764 while sealing the elongated member against air ingress during suction.

[0048] The locking actuator 770 may be displaceable to separate positions or across a series of positions. The locking actuator 770 may be movable from open, partially open, and / or closed positions of the seal. When the locking actuator 770 is in the partially open position, the inner elongated member passing through the locking actuator 770 may be retracted or moved through the lumen of the catheter engaged with the inlet of the hemostatic valve, while the gasket of the locking actuator 770 provides a seal sufficient to prevent air from entering when vacuum is applied to the side port of the hemostatic valve during suction. Air leakage around the inner elongated member may reduce the effectiveness of suction and decrease the available volume in the vacuum syringe, but an overly tight gasket seal around the inner elongated member may hinder the easy and / or proper operation of the inner elongated member during the procedure. In one exemplary application of the hemostatic valve, during thrombectomy, the microcatheter and stent retriever may be retracted to retrieve the blood clot into the guide catheter, while the guide catheter is under complete vacuum without air leakage through the gasket of the locking actuator 770.

[0049] The locking actuator may be indexed to allow for easy and rapid selection of a position that precisely seals against the elongated member, preventing air ingress while still facilitating the retraction of the elongated member through the hemostatic valve. Specifically, with respect to thrombectomy applications, the locking actuator may be configured to prevent air ingress when the elongated member is a microcatheter having an inner diameter of 0.021” or 0.017”.

[0050] The hemostatic indicator may be movable to indicate the current position of the locking actuator. Indicator 772a may have a colored portion encoded to represent the state of the seal. Indicator 772a may be colored in three parts: a first part indicating a fully open sealing operation, a second part indicating that the sheet is operable to provide an air seal and allow the elongated member to retract, and a third part indicating a locked closed operation. Indicator 772a may be visible from one or more windows positioned on the side of the housing of the hemostatic valve, and the indicator may be a band having three regions, each with a different pattern and / or color, so that the regions visible through the windows change as indicator 772a rotates. Alternatively, indicator 772a may be visible from two windows positioned on both sides of the housing of the hemostatic valve, and indicator 772a may be a band having six regions with the same colored regions positioned on opposite sides of each other.

[0051] Figures 7B–7I illustrate hemostatic indicators 772b, 772c, 772d, and 772e that may be used in place of hemostatic indicator 772a, which has a locking actuator 770 as illustrated in Figure 7A. The hemostatic indicators 772b, 772c, and 772d in Figures 7B–7I may each have three distinctly patterned and / or distinctly colored portions to indicate the fully open, hemostatic retraction, and locked operating modes as described with respect to Figure 7A, and each indicator 772b, 772c, and 772d may be a band having six regions on the band having the same patterned and / or colored regions positioned opposite each other. As illustrated in Figures 7B and 7C, the hemostatic indicators may have dark portions, striped portions, and light portions. As illustrated in Figures 7D and 7E, the hemostatic indicator 772c may have a dark portion, a diagonally divided portion having one half of the diagonal as dark and the other half as light, and a light portion. As illustrated in Figures 7F and 7G, the hemostatic indicator 772d may have three monochromatic portions, each having a different monochromatic color. As illustrated in Figures 7H and 7I, the hemostatic indicator 772e may have three regions, each having a distinguishable monochromatic color.

[0052] Figures 8A to 8D illustrate an exemplary system 800, which includes a suction control device 820 having a trigger control interface 840 integrated with a hemostatic valve 860. Figures 8A and 8B illustrate the suction control device in its initial position, and Figure 8B is a cross-sectional view of the components of the suction control device 820. Figures 8C and 8D illustrate the suction control device in its retracted position, and Figure 8D is a cross-sectional view of the components of the suction control device 820.

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

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

[0055] 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 guide catheter 802 to stabilize the guide catheter 802. The trigger 840 can be moved from its initial position to its final position by gripping the index finger toward the thumb.

[0056] Referring to Figures 8B and 8D, the suction control device 820 may include a control valve 822 containing a compressible tube 824 having an opening 826 that is movable over a dimensional range in response to being compressed or released by a compression element 842 communicating with a trigger 840. The suction control device 820 may also be a normally closed device. In the initial position, as illustrated in Figure 8B, the compression element 842 may extend through the opening 846 in the housing 844 to provide maximum compression to the compressible tube 824. As the trigger 840 moves from the initial position, as indicated by the arrow, the grooved sleeve 854 may move over the housing portion 844. As the grooved sleeve 854 moves away from the side port 866, the compression element 842 may move into the groove 855 of the grooved sleeve 854, as illustrated in Figure 8D. The compression element 842 may be spring-loaded, or it may slide freely through an opening 846 in the housing 844, and as a result of elastic recovery, the compression tube 824 expands and presses against the compression element 842, causing it to move into the groove 855. When the compression element 842 moves into the groove 855, the compression tube 824 may expand to allow a greater flow rate through the control valve 822.

[0057] The groove 855 may be angled so that, as the grooved sleeve 854 moves along a portion 844 of the housing, away from the side port 866, and progresses from the initial position illustrated in Figure 8B to the retracted position illustrated in Figure 8D, the compression element 842 may move further progressively within the grooved sleeve 854, thereby increasing the opening 826 in the compressible tube 824. The amount of blood aspirated may be controlled by the size of the opening 826 in the compressible tube 824. Thus, the blood flow may be selected by the user over a continuous blood flow by holding the trigger 840 in a position between the initial position and the fully retracted position. The trigger 840 may be spring-loaded to return to the initial position when not being operated.

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

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

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

[0061] 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 locking actuator 970, the index finger positioned on one arm of the two-finger trigger 940, the middle finger positioned on the other arm of the two-finger trigger 940, and the remaining fingers positioned on the device and guide catheter 902 to stabilize the guide catheter 902. The trigger 940 can be moved from its initial position to its final position by gripping the index and middle fingers toward the thumb.

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

[0063] The compression element 942 may be spring-loaded, or it may slide freely through the opening 946 in the housing 944, and as a result of elastic recovery inflating the compression tube 924 and pressing the compression element 942, it moves into the groove 955. When the compression element 942 moves into the groove 955, the compression tube 924 may inflate to allow a greater flow rate through the control valve 922. The groove 955 may be angled so that, as the grooved sleeve 954 is moved away from the side port 966 along a portion of the housing 944 as indicated by the arrow, the compression element 942 may move further progressively into the grooved sleeve 954, allowing the opening 926 in the compressible tube 924 to enlarge. The amount of blood aspirated can be controlled by the size of the opening 926 in the compressible tube 924. Thus, the blood flow rate can be selected by the user over a continuous blood flow rate by holding the trigger 940 in a position between the initial position and the fully retracted position. The trigger 940 can be spring-loaded so that it returns to its initial position when not being operated.

[0064] Figures 10A to 10C illustrate an exemplary system 1000 including a suction control device 1020 having a lever interface 1040 integrated into a hemostatic valve 1060, where Figure 10A illustrates the lever interface 1040 in its initial position, Figure 10B illustrates the lever interface 1040 in its retracted position, and Figure 10C illustrates a broken view of Figure 10B. Referring together to Figures 10A to 10C, the suction control device 1020 and the hemostatic valve 1060 can be integrated into a common housing. The integrated device may include an inlet 1062 sized to receive and hemostatically seal a catheter 1002, an outlet 1064 sized to allow passage of an internal elongated member 1008 and hemostatically seal the internal elongated member 1008, a side port 1066 designed to connect to a vacuum system, a suction control valve 1022 communicating with the side port 1066, a rotary lever interface 1040 for operating the control valve 1022 to regulate the aspirated blood flow, a locking actuator 1070 positioned at the outlet 1064 and having a hemostatic seal, and a hemostatic indicator 1072 for indicating the state of hemostatic sealing at the outlet 1064.

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

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

[0067] The integrated suction control device / hemostatic 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 lever 1040, and the remaining fingers positioned on the device and guide catheter 1002 to stabilize the guide catheter 1002. The lever 1040 can be moved from its initial position to its final position by gripping it with the index finger toward the thumb.

[0068] Referring to Figures 10A and 10C, the flexible tube 1024 may have an opening 1026 that is movable over a dimensional range in response to the flexible tube 1024 bending when the lever 1040 is moved. The suction control device 1020 may be a normally open device. In the initial position, the flexible tube 1024 may be substantially straight, as illustrated in Figure 10A. The opening 1026 may be the widest opening of its maximum dimension when the flexible tube 1024 is substantially narrow and the lever is in the initial position 1040. By being configured in this way, in the initial position, the suction control device 1020 may allow maximum blood flow. When the lever 1040 is moved from the initial position in the direction indicated by the arrow in Figure 10A, the bending of the flexible tube 1024 may constrict the opening 1026, as illustrated in Figure 10C, thereby restricting blood flow. Therefore, the blood flow can be selected by the user over a continuous range by holding the lever 1040 in a position between the initial position and the fully retracted position. When the lever 1040 is released, it can be returned to the initial position by the spring 1032.

[0069] Figures 11A to 11F illustrate exemplary systems 1100, 1100a, including a suction control device 1120 having a thumb trigger 1140 integrated with a hemostatic valve 1160. Figures 11A and 11B illustrate systems having a freely sliding thumb trigger 1140, while Figures 11C to 11F illustrate systems having a thumb trigger 1140a that is ratchet-engaged in one or more predetermined positions and can be held in place until the ratchet is released. Figures 11A, 11C, and 11D illustrate the thumb triggers 1140, 1140a of each exemplary system 1100, 1100a in its initial position, while Figures 11B, 11E, and 11F illustrate the thumb triggers 1140, 1140a of each exemplary system 1100, 1100a in its compressed position. Figure 11D is a broken view illustrating the compression element 1142 and control valve 1122 positioned as shown in Figure 11C. Figure 11F is a broken view illustrating the compression element 1142 and control valve 1122 positioned as shown in Figure 11E. Referring together to Figures 11A to 11F, each of the integrated suction control devices 1120, 1120a and hemostatic valve 1160 can be integrated into a common housing. Each integrated device may include an inlet 1162 sized to receive and hemostatically seal a catheter 1102, an outlet 1164 sized to allow passage of an internal elongated member 1108 and hemostatically seal the internal elongated member 1108, a side port 1166 designed to connect to a vacuum system, a suction control valve 1122 communicating with the side port 1166, control interfaces 1140, 1140a for operating the control valve 1122 to regulate the aspirated blood flow, and a locking actuator 1170 positioned at the outlet 1164.

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

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

[0072] In either of the exemplary systems 1100, 1100a, the integrated suction control / hemostatic valve device may be grasped in one hand by the thumb positioned on the thumb trigger 1140, 1140a and the other fingers positioned on the housing of the integrated device and guide catheter 1102, thereby stabilizing the device and guide catheter 1102 and providing leverage for compressing the thumb trigger 1140, 1140a. The index finger may be positioned near the side port 1166, and the little finger may be positioned on the guide catheter 1102. The thumb trigger 1140, 1140a may be moved from the initial position illustrated in Figure 11A or Figure 11C to the compressed position illustrated in Figure 11B or Figure 11D by gripping the thumb toward the other fingers, as indicated by the arrows in Figure 11B or Figure 11D.

[0073] Referring together to Figures 11A to 11F, in any of the systems 1100, 1100a, the control valve 1122 may be positioned within a flow path extending from the lumen 1103 of the guide catheter 1102 to the side port 1166, and the control valve 1022 may regulate the flow rate of aspirated blood through the flow path. The control valve 1122 may include a compressible tube 1124 positioned to extend through a portion 1144 of the housing of the device, which extends from near the inlet 1162 of the hemostatic valve 160 to near the side port 1166. The portion of the housing 1144 may have an opening 1146 through which a compression element 1142 can pass to compress the compressible tube 1124. The compression element 1142 may be connected to thumb triggers 1140, 1140a such that when the thumb trigger is compressed, the compression element 1142 moves into the opening 1146, pressing against the compressible tube 1124 and compressing the compressible tube 1124. When the compressible tube 1124 is compressed, the opening 1126 in the tube 1124 may be narrowed to reduce blood flow through the control valve 1122. The opening 1126 may move between a range of dimensions in response to being compressed or released by the compression element 1142.

[0074] Referring together to Figures 11A to 11F, in any system 1100, 1100a, the suction control device 1120 may be a normally open device. In the initial position, the compression element 1142 may be positioned outside the opening 1146 in the housing portion 1144, and the compressible tube 1124 may be uncompressible. In the initial position, the opening 1126 in the compressible tube 1124 may have its maximum dimensions with a wide opening sized to allow maximum blood flow. The thumb trigger 1140 is moved from the initial position illustrated in Figure 11A or Figure 11C in the direction of the arrow shown in Figure 11B or Figure 11D, and the compression element 1142 may pass through the opening 1146 in the portion 1144 of the housing that holds the compressible tube 1124 and engage with the compressible tube 1124. When the compression element 1142 is pressed against the compressible tube 1124, the opening 1126 in the compressible tube 1124 may be crushed, restricting blood flow through the control valve 1122. When the compression element releases the compressible tube 1124 or moves toward its initial position, the opening 1126 in the compressible tube 1124 may expand as a result of the elastic recovery within the tube that presses against the open tube and / or the elastic properties of the material of the compressible tube 1124.

[0075] Referring to the system 1100 illustrated in Figures 11A and 11B, the thumb trigger 1140 and compression element 1142 may be integrated into a single molded component 1156, which may be mounted in a common housing for the integrated suction control device and hemostatic valve. The compression element 1142 may be fixed to the thumb trigger 1140, meaning that when the physician engages the thumb trigger 1140, the compression element 1142 is translated through the same distance as the thumb trigger 1140. Component 1156 may pass through a second portion 1158 of the housing. The second portion 1158 may be sized to stabilize component 1156 relative to the entire device.

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

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

[0078] Figure 12 illustrates an exemplary system 1200, which includes a suction control device 1220 having a side grip interface 1240 integrated into a hemostatic valve 1260. The side grip interface 1240 may include a compressible button to change 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 within a 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 with an opening that can be adjusted by pressing the side grip 1240. The suction control device 1220 can be positioned so that a physician can adjust the flow rate through the channel using the side grip 1240, while simultaneously stabilizing the guide catheter 1202 and withdrawing a pull wire or other internal elongated member from the outlet 1264 of the hemostatic valve 1260.

[0079] The side grip 1240 can be compressed as a binary switch that switches between maximum and minimum blood flow rates. Alternatively, the side grip 1240 can be clicked at continuous flow rates, with each click progressively selecting a higher or lower flow rate, ending with a reset click that returns the flow rate to the starting rate. Alternatively, the side grip 1240 can adjust the flow rate over continuous flow rates in response to the force applied to the side grip, with the flow rate being directly or inversely proportional to the force. In either configuration, the suction control device 1220 can be a normally open or normally closed device.

[0080] Figures 13A to 13E illustrate examples of blood flow indicators that may be used to show blood flow through a suction control device. The blood flow indicators illustrated in Figures 13A to 13E may be placed within the flow path, including the control valve of the suction control device. Several specific exemplary suction control devices 120, 420, and 1120 disclosed herein include blood flow indicators 152, 452, and 1152 (see Figures 1, 4, 11A, and 11B), which may be designed as illustrated in Figures 13A to 13E or as other designs having a similar function. Other examples disclosed herein are also intended to include blood flow indicators, such as those illustrated in Figures 13A to 13E or as other designs having a similar function.

[0081] A visual indicator of blood flow is intended to be achieved by providing a transparent material along the blood flow path so that the blood in the path can be observed by a physician or user. Figure 13A illustrates a pinwheel flow indicator that is positioned within a flow path and can be contained by a transparent material. In addition to allowing a physician to confirm the presence of blood in the flow path, the pinwheel may be visible through the transparent material along the blood flow path. The pinwheel may spin faster as the blood flow increases, and the physician may be provided with a visual indicator of blood flow by the spinning speed of the pinwheel. Alternatively, the blood does not need to be visible, as long as at least a portion of the pinwheel is visible and that portion is moving as a visual indicator of blood flow.

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

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

[0084] Figure 14A illustrates an exemplary system 1400 including a suction control device 1420 controlled by a push-button interface 1440, the suction control device 1420 being integrated with a hemostatic valve 1460 in a common housing. Figures 14B to 14D illustrate various embodiments and configurations of the suction control device 1420.

[0085] The push-button interface 1440 may include a compressible button to change the flow rate of aspirated blood through the suction control device 1420. The catheter 1402 may be received by the inlet 1462 of the hemostatic valve 1460, and the suction control device 1420 may be positioned within the flow path from the catheter 1402 to the side port 1466 of the hemostatic valve 1460. The side port 1466 may be sized to connect to a vacuum system such as a vacuum pump or syringe. The suction control device 1420 may have an internal valve that can be adjusted by pressing the side grip 1440. The push-button interface 1420 may be positioned so that a physician can adjust the flow rate through the flow path using the push-button 1440, while simultaneously stabilizing the guide catheter 1402 and withdrawing a pull wire or other internal elongated member from the outlet 1464 of the hemostatic valve 1460.

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

[0087] Figure 14C illustrates a modified configuration of the spring 1432 of the suction control device 1420 described in relation to Figure 14B.

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

[0089] Figure 15 illustrates an exemplary system 1500 including a hemostatic valve 1560 and an integrated suction control device 1520. The integrated suction control device 1520 and the hemostatic valve 1560 may be integrated into a common housing. The integrated device may have an inlet 1562 sized to receive and hemostatically seal a catheter 1502, an outlet 1564 sized to allow passage of an internal elongated member and to hemostatically seal the internal elongated member, a side port 1566 designed to connect to a vacuum system, a suction control valve communicating with the side port 1566, and a switch interface 1540 for operating the control valve to regulate the aspirated blood flow. The control valve may be positioned in a flow path extending from the lumen of the catheter 1502 to the side port 1566, and the control valve may regulate the aspirated blood flow through the flow path. The switch interface 1540 may include a lever rotatable around a joint 1550 connected to the housing of the device. The control valve may have an opening that resizes as the lever of the switch interface 1540 rotates around the joint 1550, thereby regulating the flow rate of blood aspirated. The lever of the switch interface 1540 may be spring-loaded to return to its default position when not being operated. Alternatively, the switch interface 1540 may maintain its most recently moved position when not being operated.

[0090] Figure 16 illustrates an exemplary system 1600, which includes two suction control devices 1620, 1621 configured to regulate suction through two catheters 1602, 1604 with two hemostatic valves 1660, 1680 having a single vacuum source. System 1600 can simultaneously provide suction force to the two catheters 1602, 1604 from a single vacuum source. The suction control devices 1620, 1621 can provide control so that the simultaneous suction force provided to each of the catheters 1602, 1604 is different from that of the other.

[0091] 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 allow 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 suction control device 1620 positioned to regulate blood flow through a channel from the lumen of the guide catheter 1602 to the first side port 1666 of the first hemostatic valve 1660. The first suction control device 1620 may be integrated with the first hemostatic valve 1660 into 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 tube 1616. The first hemostatic valve 1660 may include an outlet locking actuator 1670 for engaging and sealing the intermediate catheter 1604.

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

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

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

[0095] The first suction control device 1620 and the second suction device 1621 may be designed according to the examples and principles disclosed herein and do not need to be specially designed as illustrated in Figure 16.

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

[0097] The control valve may have an opening that is sized according to an electrically actuated mechanism such as a motor. The electric actuator may be programmed to have a set of flow rates and / or a predetermined sequence of valve opening positions, which can be selected by a physician via interface 1740. When the electric actuator is actuated, the opening of the control valve may be sized according to the selected program.

[0098] In some cases, the program may include specific waveforms or flow patterns. In some applications, it may be advantageous to pulsate or vary the vacuum to increase the likelihood that the catheter can completely aspirate the blood clot, or if the blood clot has a high fibrin content and cannot be completely aspirated, a pulsating vacuum may allow the catheter to obtain an improved grip on the blood clot. This may be beneficial when the suction control valve is used with balloon-guided catheters, guide sheaths, or intermediate or other catheters used in thrombectomy.

[0099] The control interface 1740 may include a mechanism for selecting a program for an electric actuator and for operating the electric actuator to execute the program. Interface 1740 may include mechanical inputs that can be operated by a physician to operate the electric actuator, such as sliders, push buttons, switches, wheels, triggers, grips, levers, rotary valves, handles, and / or other mechanisms, as described in relation to a mechanically controlled suction control valve. Additionally or alternatively, interface 1740 may include a touchscreen, touchpad, multiple push buttons, text and / or video display, or other types of electric device user interfaces.

[0100] Figures 18 to 20 are flowcharts, each including steps of a method for controlling aspiration during thrombectomy. Figure 21 is a flowchart including steps of a method for blood clot recovery. The steps of the method may be carried out by any of the exemplary systems, devices, and / or apparatus described herein, or by means known to those skilled in the art. Steps of one or more methods from methods 1800, 1900, 2000, and 2100 may be combined.

[0101] Referring to method 1800 outlined in Figure 18, step 1808 may provide a hemostatic valve having a distal port and a side port. Step 1816 may provide a suction control device having a control valve and a control interface. Step 1824 may position the suction control device in close proximity to the side port. Step 1832 may arrange the hemostatic valve and control valve within a common housing. Step 1840 may provide a catheter. Step 1848 may position the catheter within the distal port of the hemostatic valve. Step 1856 may provide a vacuum source. Step 1864 may attach the vacuum source to the side port. Step 1872 may provide a flow path extending from the lumen of the catheter to the side port. Step 1880 may operate the control interface to control the flow rate through the flow path. Step 1888 may stabilize the catheter and operate the control interface with one hand simultaneously.

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

[0103] Referring to method 2000 outlined in Figure 20, in step 2010, the control interface may be moved from its initial position by applying force to the control interface. In step 2020, the control interface may be released. In step 2030, the control interface may be returned to its initial position.

[0104] Referring to Method 2100 outlined in Figure 21, some or all of the steps may be performed by a physician using exemplary systems 100, 200, 300, 400, 500, 600, 800, 900, 1000, 1100, 1100a, 1200, 1400, 1500, 1600, 1700, variations thereof, and equivalent systems with balloon-guided catheters, microcatheters, and blood clot recovery devices for removing blood clots from the neurovascular system.

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

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

[0107] In step 2106, the microcatheter and the blood clot recovery device may be positioned for the procedure. The microcatheter may be positioned such that the distal portion of the microcatheter passes through the blood clot, the majority of the length of the microcatheter passes through the balloon guide 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 the microcatheter is being positioned, the valve at the inlet of the hemostatic valve may be fully opened. The blood clot recovery device may be introduced through the microcatheter after the microcatheter has been positioned across the blood clot using standard intervention techniques. A portion of the blood clot recovery device, configured to spread within the blood clot, may be positioned within the portion of the microcatheter positioned within the blood clot. The valve at the inlet of the hemostatic valve may be locked to the microcatheter while the blood clot recovery device is being supplied into the microcatheter.

[0108] In step 2108, the blood clot retrieval device may be deployed. To deploy the blood clot retrieval device, the microcatheter may be retracted so that the blood clot retrieval device maintains its position within the blood clot while the distal end of the microcatheter is proximal to the blood clot. In this way, the blood clot retrieval device may have its sheath removed, and once the sheath is removed, it may expand within the blood clot. While the microcatheter is retracted, the valve at the inlet of the hemostatic valve may be locked in an intermediate position around the microcatheter to minimize blood loss.

[0109] In step 2110, a suction control valve may be closed at the side port of the hemostatic valve. The suction control valve may be integrated into the hemostatic valve or attached to a suction control valve having a side port, a variation thereof, or an equivalent function as described and illustrated in the examples herein.

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

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

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

[0113] When the suction control valve is open, blood can flow from the patient's blood vessel into the balloon-guided catheter, allowing the thrombus to be freely drawn into the catheter. Alternatively, or additionally, the balloon-guided catheter may be configured to occlude the blood vessel to provide reverse blood flow, improving the effectiveness of the thrombus retrieval device for complete removal and retrieval of the thrombus in step 2116.

[0114] In step 2118, after the blood clot recovery device has partially retracted (for example, past the terminal of the internal carotid artery), the aspiration control device may be operated to increase the flow rate to a moderate flow rate into the syringe, pump, or other vacuum source.

[0115] In step 2021, after the blood clot recovery device has been further retracted (for example, when the blood clot recovery device is near the distal end of the balloon guide catheter), the aspiration control device may be operated to allow for a high flow rate.

[0116] In step 2122, the blood clot recovery device may be retracted into the balloon-guided catheter while the suction control device is set to allow the maximum flow rate. In steps 2118-2122, the microcatheter may be retracted together with the blood clot recovery device.

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

[0118] The descriptions contained herein are examples of embodiments of the present invention and do not limit the scope of the invention in any way. As described herein, the present invention intends many variations and modifications of systems and devices for aspirating blood flow, including integrating a suction control device with another treatment device, attaching a suction control device to another conventional treatment device, using one or more suction control devices to control the flow rate through one or more channels, using various configurations of control valves, using various configurations of control interfaces, using various combinations of components to achieve the described functions, using alternative materials to achieve the described functions, combining components from various examples, and combining components from various examples with known components. The present invention intends to replace the component components exemplified herein with known component components, including known control valves, control interfaces, indicators, etc. These modifications will be obvious to those skilled in the art to whom the present invention relates and are intended to be within the scope of the following claims.

[0119] [Implementation Method] (1) A system, A hemostatic valve including an entrance for receiving a catheter, A control valve communicating with the hemostatic valve, wherein the control valve includes an opening movable between a first dimension sized to restrict the flow of blood aspirated from the catheter to a first flow rate and a second dimension sized to restrict the flow of blood aspirated from the catheter to a second flow rate, A system comprising: a control interface communicating with the control valve, wherein the control interface is movable such that it moves the opening of the control valve from a first dimension to a second dimension. (2) The system according to Embodiment 1, wherein the hemostatic valve further comprises a side port, and the control valve is disposed adjacent to the side port. (3) The system according to Embodiment 2, wherein the control valve is positioned to provide a flow path for the flow of the blood to be aspirated, and the flow path extends from the catheter through the control valve to the side port. (4) The system according to Embodiment 1, wherein the control valve, the control interface, and the hemostatic valve are fixed to a common housing. (5) The system according to Embodiment 1, wherein the control interface is positioned to allow the user to select either the first flow rate or the second flow rate with one hand while stabilizing the catheter with the other hand.

[0120] (6) The system according to Embodiment 1, wherein the control interface is movable to select at least one of the first flow rate or the second flow rate, at least in part based on a force applied to the control interface. (7) The system according to Embodiment 1, wherein the opening is movable over a continuous dimension between the first dimension and the second dimension so that the flow of the aspirated blood can be controlled over a continuous flow between the first flow rate and the second flow rate. (8) The hemostatic valve, An outlet sized to allow passage through an inner, elongated member disposed within the lumen of the catheter, A seal is provided adjacent to the aforementioned outlet, A locking actuator that is displaceable to open the seal in a first position, partially open the seal in a second position, and close the seal in a third position, The system according to embodiment 1 further comprises a hemostatic indicator that is movable to provide a visual indicator of the position of the locking actuator. (9) The hemostatic indicator includes an indicator with a mark corresponding to a predetermined semi-open position of the locking actuator, In the predetermined semi-open position, the locking actuator is sized to allow the inner elongated member, which has an inner diameter of approximately 0.432 mm to 0.533 mm (approximately 0.017 inches to 0.021 inches), to slide and translate through the locking actuator. The system according to embodiment 8, wherein in the predetermined semi-open position, the locking actuator is sized to prevent air from entering the hemostatic valve from around the inner elongated member. (10) A device, A distal port sized to receive a catheter, A proximal port sized to allow passage of an inner elongated member, wherein the inner elongated member is disposed within the lumen of the catheter, The first side port, A first flow path extending from the lumen of the catheter to the first side port, A control valve communicating with the lumen and the first side port of the catheter, wherein the control valve is movable to control blood flow through the first passage, A device comprising a control interface communicating with the control valve, wherein the control interface includes at least two positions, the at least two positions corresponding to at least two flow rates of the blood flow through the first passage.

[0121] (11) The apparatus according to Embodiment 10, wherein the control interface includes a sliding button positioned to allow the user to simultaneously select one of the at least two positions with one hand while stabilizing the catheter with the other hand. (12) The apparatus according to Embodiment 10, wherein the control interface includes a push button, the push button is movable between the at least two positions as a result of a force applied to the push button, and the push button is positioned to allow a user to simultaneously select one of the at least two positions with one hand while stabilizing the catheter with the other hand. (13) The second side port, The present invention further comprises a second flow path extending from the second side port to the first side port, The control valve is in communication with the second side port and the first side port, The apparatus according to embodiment 10, wherein the control valve is movable to control the blood flow through the second passage. (14) A method for aspirating blood flow, To provide a hemostatic valve equipped with a distal port and a side port, To provide a suction control device equipped with a control valve and a control interface, Positioning the suction control device in close proximity to the side port, To provide a catheter, Positioning the catheter within the distal port of the hemostatic valve, To provide a vacuum source, To provide a flow path from the lumen of the catheter to the side port, Positioning the control valve of the suction control device within the flow path, To provide a vacuum in the flow path using the vacuum source, A method comprising controlling the flow rate through the flow path by operating the control interface. (15) The method according to embodiment 14, further comprising stabilizing the catheter with a first hand while simultaneously operating the control interface with one hand.

[0122] (16) The method according to embodiment 14, further comprising arranging the hemostatic valve and the suction control device within a common housing. (17) Positioning a flexible tube within the flow path, wherein the flexible tube includes an opening, To provide a compression element that communicates with the aforementioned control interface, Positioning the compression element so as to engage with the flexible tube, The method of embodiment 14, further comprising moving the compression element by operating the control interface to resize the opening of the flexible tube. (18) To provide a housing including an opening, Positioning the flexible tube within the housing, The method according to embodiment 17, further comprising positioning the compression element within the opening in the housing. (19) Controlling the flow rate through the flow path by operating the control interface, The method according to Embodiment 14, comprising moving the control interface from its initial position by applying force to the control interface. (20) Releasing the control interface, The method according to embodiment 19, further comprising returning the control interface to the initial position.

Claims

1. It is a system, A hemostatic valve including an entrance for receiving a catheter, A control valve communicating with the hemostatic valve, the control valve includes a compressible tube having a longitudinal central axis, the control valve having an open lumen portion that can move between a first dimension sized to limit the flow of blood aspirated from the catheter to a first flow rate and a second dimension sized to limit the flow of blood aspirated from the catheter to a second flow rate; The control interface and the compression element are connected to the control valve and the compression element, wherein the compression element is movable such that it moves the open lumen portion of the compressible tube from the first dimension to the second dimension. The compression element is connected to the control interface in a spring-loaded manner so as to return to its initial position when the control interface is not being operated, and is configured such that when the control interface is released, the compression element moves as a result of the spring mechanism, moving radially inward relative to the longitudinal axis within a lateral opening in the housing that extends along the longitudinal axis and houses the compressible tube, thereby moving the control interface toward its initial position and narrowing the open lumen portion within the compressible tube. In the initial position, the compression element is configured to extend radially inward with respect to the longitudinal central axis through the lateral opening within the housing, thereby providing maximum compression to the compressible tube. As the control interface moves distally along the longitudinal central axis from its initial position, the compression element is configured to contact the distal edge of the lateral opening within the housing, and as the contact point moves from the distal to the proximal end of the compression element, it bends radially outward so as to move away from the longitudinal central axis of the compressible tube. The compression element is configured to move from the initial position to a retracted position as a result of the control interface being gripped and moving distally, and in the retracted position, the compression element is bent so as to retract outward from the lateral opening in the housing, the system.

2. The system according to claim 1, wherein, in the retracted position, when the compression element bends away from the compressible tube, the open lumen portion within the compressible tube is configured to widen to allow a greater flow rate through the control valve.

3. The system according to claim 1 or 2, wherein the open lumen of the compressible tube is movable over a continuous dimension between the first dimension and the second dimension, such that the flow of the aspirated blood can be controlled over a continuous flow between the first flow rate and the second flow rate.

4. A system, A hemostatic valve including an entrance for receiving a catheter, A control valve communicating with the hemostatic valve, the control valve includes a compressible tube having a longitudinal central axis, the control valve having an open lumen portion that can move between a first dimension sized to limit the flow of blood aspirated from the catheter to a first flow rate and a second dimension sized to limit the flow of blood aspirated from the catheter to a second flow rate; The control interface and the compression element are connected to the control valve and the compression element, wherein the compression element is movable such that it moves the open lumen portion of the compressible tube from the first dimension to the second dimension. The compression element is connected to the control interface in a spring-loaded manner so as to return to its initial position when the control interface is not being operated, and is configured such that when the control interface is released, the compression element moves as a result of the spring mechanism, moving radially inward relative to the longitudinal axis within a lateral opening in the housing that extends along the longitudinal axis and houses the compressible tube, thereby moving the control interface toward its initial position and narrowing the open lumen portion within the compressible tube. The hemostatic valve, An outlet sized to allow passage through an inner, elongated member disposed within the lumen of the catheter, A seal is provided adjacent to the aforementioned outlet, A locking actuator that is displaceable to open the seal in a first position, partially open the seal in a second position, and close the seal in a third position, The system further comprises a movable hemostatic indicator to provide a visual indicator of the position of the locking actuator.

5. The hemostatic indicator includes an indicator with a mark corresponding to a predetermined semi-open position of the locking actuator, In the predetermined semi-open position, the locking actuator is sized to allow the inner elongated member, which has an inner diameter of 0.432 mm to 0.533 mm (0.017 inches to 0.021 inches), to slide and translate through the locking actuator. The system according to claim 4, wherein in the predetermined semi-open position, the locking actuator is sized to prevent air from entering the hemostatic valve from around the inner elongated member.

6. The system according to any one of claims 1 to 3, wherein the control interface includes a sliding button positioned to allow the user to simultaneously select one of the initial position and the retracted position with one hand while stabilizing the catheter with the other hand.

7. The system according to any one of claims 1 to 3, wherein the control interface includes a push button, the push button is movable between an initial position and a retracted position as a result of a force applied to the push button, and the push 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 other hand.

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