Systems and methods for removing blood and thrombotic material - Patents.com
Patent Information
- Application Number
- JP2023548847
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-02-14
- Filing Date
- 2022-02-15
- Publication Date
- 2025-01-30
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
Existing thrombectomy devices face limitations such as occlusion, slow operation, and potential vessel wall disruption due to high pressure, leading to increased procedure time and risk of bradycardia events, especially when dealing with complex thrombotic material.
A thrombus aspiration system with a combined hydraulic-electrical control mechanism, utilizing a catheter with separate lumens for fluid injection and suction, controlled by a foot-operable interface that synchronizes fluid injection and suction, ensuring efficient and safe removal of thrombotic material.
The system provides rapid and controlled thrombus aspiration with reduced risk of vessel wall disruption, allowing single-user operation and minimizing procedure time, while maintaining safety by preventing fluid backflow and ensuring consistent aspiration performance.
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Abstract
Description
[Technical field]
[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to medical devices and methods of their use, and more particularly, the present invention relates to an aspiration and thrombus removal device and methods of use thereof. [Background technology]
[0002] Several devices and systems already exist to aid in the removal of thrombotic material. These include simple suction tube type devices that use a vacuum syringe to extract the clot into the syringe, simple evacuation and aspirate devices, more complex devices with rotating components, and systems that use mechanical augers to draw, crush and transport thrombotic material from a distal tip, creating a Venturi effect that uses very high pressure to crush the clot and flush the crushed material away.
[0003] Each of the above-mentioned devices has limitations due to their respective design characteristics. For example, simple aspiration catheters offer ease of use and rapid deployment, but can become occluded or otherwise inoperable when faced with older, more organic thrombotic material. Such devices must be detached and removed outside the body and then reinserted into the vasculature, which increases the time required for the procedure and increases the chance of kinking the catheter shaft. Such kinking can reduce performance by reducing the cross-sectional area of the catheter or can render the device inoperable.
[0004] Mechanical rotation devices use an auger to grab the thrombus and carry it away from the area of interest. Some generate the transport force through a vacuum bottle, while others use an auger that acts as a low pressure pump to generate a pressure differential at the distal tip of the device. These devices typically work slowly and do not provide the physician with feedback as to when to advance the device further into the lesion. Summary of the Invention [Problem to be solved by the invention]
[0005] Evacuation devices include manual flushing devices in which the physician operates a manually driven pump to deliver flowing saline to the tip of the device to break up and aspirate thrombotic material, which may introduce performance variability based on the physician's ability to consistently pump the device over the duration of the procedure. Evacuation devices also include high pressure ejection devices that break up the clot and then use a vortex generated by high pressure fluid to transport the emulsified thrombotic material to a collection bag. While these devices are effective in removing all levels of thrombotic material, the pressure generated by the device is so great that its action on certain vessel walls may interrupt the myocardial stimulation mechanism and cause bradycardia events in certain patients, which may require the placement of a pacing lead in the patient prior to use. Additionally, interacting with thrombotic material on the outside of the catheter may allow the liberated material to escape the capture mechanism. [Means for solving the problem]
[0006] In one embodiment of the present disclosure, a system for thrombus aspiration includes an aspiration catheter including an elongate shaft configured for placement within a blood vessel of a subject, a supply lumen and an aspiration lumen, each extending along the shaft, the supply lumen having a proximal end and a distal end, the aspiration lumen having a proximal end and a distal opening, and an opening at or near the distal end of the supply lumen configured to allow for infusion of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen when the pressurized fluid is pumped through the supply lumen, and a distal end configured to couple to the aspiration lumen of the aspiration catheter and a distal end configured to couple to a negative pressure source. and a passageway extending between the distal and proximal ends of the extension conduit; a composite hydraulic-electrical control device carried on the extension conduit and including a first control interface and a control body, the first control interface configured to be actuated by a user to move the control body between a first position and a second position; an electrical switch configured to be actuated by the control body when the control body is moved to the second position; and a valve having a closed position that blocks flow through the passageway of the extension conduit and an open position that allows flow through the passageway of the extension conduit, the valve configured to be moved from the closed position to the open position by the control body when the control body is moved to the second position.
[0007] In another embodiment of the present disclosure, an extension conduit for use with a thrombus aspiration system includes a passageway extending between a distal end and a proximal end of the extension conduit, and a composite hydraulic-electrical control carried on the extension conduit and configured to be actuated by a user to activate an electrical switch while opening a valve to allow flow through the passageway.
[0008] In yet another embodiment of the present disclosure, an extension conduit for use with a thrombus aspiration system includes a passageway extending between a distal end and a proximal end of the extension conduit, and a composite hydraulic and electrical control carried on the extension conduit and configured to be actuated by a user to deactivate an electrical switch while closing a valve to stop flow through the passageway. [Brief description of the drawings]
[0009] [Figure 1] FIG. 13 is a plan view of disposable components of a system for thrombus aspiration, according to an embodiment of the present disclosure. [Diagram 2] 2 is a cross-sectional view of the distal end of the aspiration catheter of the thrombus aspiration system of FIG. 1. [Diagram 3] FIG. 2 is a detailed view of the y-connector of the aspiration catheter of the thrombus aspiration system of FIG. 1. [Figure 4] 1 is a plan view of disposable components of a system for thrombus aspiration according to an embodiment of the present disclosure. FIG. [Diagram 5] FIG. 5 is a perspective view of the thrombus aspiration system of FIG. 4. [Figure 6] FIG. 1 is a perspective view of a suction tube set having a control device according to an embodiment of the present disclosure. [Figure 7] FIG. 7 is a plan view of the feeding suction tube and control device of FIG. [Figure 8] FIG. 7 is a diagram of intern components of the control device of FIG. 6. [Figure 9] FIG. [Figure 10] FIG. 2 is an exploded view of certain internal components of the control device. [Figure 11] FIG. 13 is a cross-sectional view of a control device in a closed position according to an embodiment of the present disclosure. [Figure 12] FIG. 2 is a cross-sectional view of a control device in an open position according to an embodiment of the present disclosure. [Figure 13] FIG. 13 is a cross-sectional view of a control device in a closed position according to an alternative embodiment of the present disclosure. [Figure 14] FIG. 14 is a cross-sectional view of the control device of FIG. 13 in an open position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0010] A system 2000 for thrombus aspiration is shown in FIG. 1. The system 2000 for thrombus aspiration includes three main components: a pump 200, an aspiration catheter 2018, and a tubing set 2003. The aspiration catheter 2018 and the tubing set 2003 represent disposable components 2001, while the pump 200 and its associated pump base are reusable components. The pump 200 does not need to be sterilized since it may be kept in a non-sterile field or area during use. The aspiration catheter 2018 and the tubing set 2003 may each be supplied sterile after sterilization by ethylene oxide gas, electron beam, gamma radiation, or other sterilization methods. The aspiration catheter 2018 may be packaged and supplied separately from the tubing set 2003, or the aspiration catheter 2018 and the tubing set 2003 may be packaged and supplied together. Alternatively, the suction catheter 2018 and tubing set 2003 may be packaged separately, but may be supplied together (i.e., bundled). The suction catheter 2018 has a distal end 2020 and includes an over-the-wire guidewire lumen / aspiration lumen 2032 extending between an open distal end 2036 and a proximal end 2019 including a y-connector 2010. A catheter shaft 2042 of the suction catheter 2018 is connected to the y-connector 2010 via a protective strain relief 2056. In other embodiments, the catheter shaft 2042 may be attached to the y-connector 2010 using a luer fitting. The y-connector 2010 includes a first female luer 2055 in communication with the catheter supply lumen 2093 (FIG. 2) and a second female luer 2051 in communication with the guidewire lumen / aspiration lumen 2032.
[0011] A spike 2002 for coupling to a fluid source 20 (e.g., saline bag, saline bottle) allows fluid to enter through an extension tube 2022 and flow into a supply tube 2030. An optional injection port 2028 allows for injection of a substance or removal of air as described in connection with previous embodiments. A cassette 2016 having a moveable piston 2015 is used in conjunction with a mechanical actuator 2017 of the pump 200. Fluid is pumped into the injection tube 2052 from the action of the cassette 2016 applied by the actuator 2017 of the pump 200. A male luer 2054 in hydraulic communication with the catheter supply lumen 2093 through the injection tube 2052 is configured to attach to a female luer 2055 of the y-connector 2010.
[0012] An attachment 2057 is shown intended to apply a vacuum source, such as a syringe 2049 having a plunger 2067 and a barrel 2099, to the suction lumen 2032 of the catheter 2018. The syringe 2049 is attached to a vacuum line 2008 via a luer 2065 of the syringe 2049. A stop cock 2047 may be used on the luer 2065 to maintain the vacuum, or the plunger 2067 may be a locking style plunger configured to be locked in a retracted (vacuum) position. A male luer 2053 on the end of the vacuum line 2008 may be removably secured to a female luer 2051 of a y-connector 2010 of the suction catheter 2018. As shown in more detail in FIG. 3, a pressure sensor or pressure transducer 2006 is secured inside the internal cavity 2097 of the y-connector 2010 adjacent to the female luer 2055 and the female luer 2051. A valve 2095, such as a Touhy-Borst, at the proximal end of the y-connector 2010 allows the guidewire lumen / aspiration lumen 2032 around the guidewire 2091 to be hemostasis. In other embodiments, the valve 2095 may comprise a longitudinal spring-loaded seal. The guidewire 2091 may be fully inserted through the guidewire lumen / aspiration lumen 2032. The signal output from the pressure sensor 2006 is transmitted via cable 2012 to the connector 2014. The connector 2014 plugs into a socket 308 of the pump 200. The pressure related signal may be processed by the circuit board 304 of the pump 200. The pressure transducer 2006 may be powered from the pump 200 via the cable 2012. Accessories 2057 may also be supplied to the user in a sterile condition.
[0013] The foot pedal 2021 is configured to operate a pinch valve 2023 to occlude or open the vacuum line 2008. The foot pedal 2021 includes a base 2025 and a pedal 2027 and is configured to be placed on a non-sterile area, such as a floor, beneath a procedure table / bed. When a user presses the pedal 2027, a signal is sent along a cable 2029 connected to an input jack 2037 of the pump 200 via a plug 2041. The vacuum line 2008 extends through a portion of the pump 200. The pump's circuit board 304 may include a controller 303 configured to receive one or more signals from the foot pedal 2021 indicating on or off. The controller of the circuit board 304 may be configured to longitudinally move an actuator 2031 carried by the pump 200 to compress and occlude the vacuum line 2008 between an actuator head 2033 attached to the actuator 2031 and an anvil 2035 also carried by the pump 200. By stepping on the pedal 2027, the user can occlude the vacuum line 2008 and therefore stop applying negative pressure. By stepping on the pedal 2027, the user can also cause a reverse action, in which the actuator head 2033 opens the vacuum line 2008 by moving away from the anvil 2035. The anvil 2035 can have a flat (planar) shape, or a U-shape (e.g., semi-cylindrical), or a V-shape (e.g., V-block), and contacts the tube of the vacuum line 2008. Furthermore, the actuator head 2033 can have a flat (planar) shape, or a U-shape (e.g., semi-cylindrical), or a V-shape (e.g., V-block), and contacts the vacuum line 2008. The foot pedal 2021 can be operated by alternately impacting the pedal 2027 to alternately move the actuator 2031 in a first direction and an opposite second direction, respectively. In one embodiment, when the pedal 2027 of the foot pedal 2021 is depressed, the controller may be configured to open the pinch valve 2023.
[0014] Thus, the pressure transducer 2006 senses the negative pressure and sends a signal to the controller to start the motor 302 of the pump 200. Because the effect via the electronics is substantially immediate, the motor 302 begins pumping almost immediately after the pedal 2027 is depressed. When the pedal 2027 of the foot pedal 2021 is released, the controller then causes the pinch valve 2023 to close. In this way, the pressure transducer 2006 senses that there is no negative pressure and the controller 303 stops the motor 302 of the pump 200. Again, the effect via the electronics is substantially immediate, so the motor 302 stops pumping almost immediately after the pedal 2027 is depressed. During the sterilization procedure, the primary interventionist is typically "scrubbed" so that their hands only touch items in the sterile field. However, the feet / shoes / shoe covers are not in the sterile field. Thus, again, one user can operate the switch (via the pedal 2027) while also operating the catheter 2018 and the guidewire 2091. However, it is the hands in the sterile area and the feet in the non-sterile area that are used. Alternatively, the foot pedal 2021 may include two pedals, one for occlusion and the other for opening. In an alternative foot pedal embodiment, the pedal 2027 may operate a pneumatic line to cause a pressure-activated valve or cuff to occlude and open the vacuum line 2008, for example by moving the actuator head 2033. In another alternative embodiment, the pedal 2027 may rotate, slide, or move a mechanical element, such as a flexible pull cable or push rod coupled to the actuator 2031, to move the actuator head 2033. The cable 2029 may be supplied sterilized and connected to the base 2025 prior to the procedure. Thus, occlusion and opening of the vacuum line 2008 acts as an on and off switch for the pump 200 (via the pressure sensor 2006). Thus, the on / off function can be performed by the user, whose hands can be focused on manipulating sterile catheters, guidewires, and accessories, while their feet can turn the pump on and off in a non-sterile environment.This allows a single user to control the entire or majority of the operation of the system for thrombus aspiration 2000. This can be an advantage in terms of both rapid and synchronized procedures, but also useful in laboratories where additional assistants are not available. The actuator 2031 and anvil 2035 can be controlled to compress the vacuum line 2008 with a particular force, and the actuator 2031 can be controlled to move at a particular speed, either when compressing or when removing compression. Control of speed and force allows for appropriate response times, but can also add durability to the vacuum line 2008, for example, by not overcompressing.
[0015] The foot pedal 2021 may communicate with the pinch valve 2023 via a wired connection through the pump 200 or may communicate with the pinch valve 2023 wirelessly.
[0016] Returning to FIG. 1 , the plug 2041 includes an identification component 2043 that can be read by a circuit (e.g., circuit board 304) coupled to the input jack 2037 of the pump 200. In one embodiment, the identification component 2043 comprises a resistor having a particular value. When the plug 2041 is connected to the input jack 2037, the circuit of the input jack 2037 sends a current through the resistor, so that the pump 200 is electronically placed in a "foot pedal" mode, and the foot pedal 2021 can be used to control the operation of the pinch valve 2023. Alternatively, when the plug 2041 is removed from the input jack 2037 and the circuit cannot identify the resistor, the pump 200 is placed in a "manual" mode, and the pump can be controlled only by the button 232. In other embodiments, instead of a resistor, the identification component 2043 may comprise an RFID (radio frequency identification) chip that is read by a circuit when the plug 2041 is connected to the input jack 2037. In other embodiments, a proximity sensor, such as a Hall Effect device, may be utilized to determine whether or not the plug 2041 is connected to the input jack 2037 .
[0017] It should be noted that in certain embodiments, the pinch valve 2023 and foot pedal 2021 may be incorporated for on / off operation of the pinch valve 2023 on the vacuum line 2008 without utilizing the pressure sensor 2006. Indeed, in some embodiments, the pressure sensor 2006 may not be present in the system for thrombus aspiration 2000, and the foot pedal 2021 is used as the primary means of control.
[0018] 2, a supply tube 2087 including a catheter supply lumen 2093 extends freely and coaxially within the over-the-wire guidewire lumen / aspiration lumen 2032. At least a distal end 2089 of the supply tube 2087 is secured to an inner wall 2085 of the guidewire lumen / aspiration lumen 2032 of the catheter shaft 2042 by adhesive, epoxy, hot melt, thermal bonding, or other fastening manner. A plug 2083 is secured within the catheter supply lumen 2093 at the distal end 2089 of the supply tube 2087. The plug 2083 blocks the egress of the pressurized fluid, thus forcing the pressurized fluid to exit through an orifice 2081 in the wall 2079 of the supply tube 2087. The orifice 2081 may comprise a number of different shapes including, but not limited to, a circular hole, an oval hole, an elliptical hole, a longitudinally extending slit, a circumferentially extending slit, or combinations and modifications thereof. The freely coaxial relationship between the supply tube 2087 and the catheter shaft 2042 along their respective lengths allows for improved flexibility. In certain embodiments where it is desired that the proximal end of the aspiration catheter 2018 be stiffer (e.g., to make it pushable or even torqueable), the supply tube 2087 may be fixed to the inner wall 2085 of the guidewire lumen / aspiration lumen 2032 of the catheter shaft 2042 along the proximal portion of the aspiration catheter 2018, but not along the distal portion. This may be appropriate, for example, when the proximal portion of the aspiration catheter 2018 does not need to track through tortuous vasculature, but the distal portion does.The free, substantially unconnected coaxial relationship between the supply tube 2087 and the catheter shaft 2042 along their respective lengths can also be utilized to optimize flow through the guidewire lumen / aspiration lumen 2032, as the supply tube 2087 can move out of the way due to the force of the flow (e.g., clot / saline) on its outer surface, such that the remaining luminal space of the guidewire lumen / aspiration lumen 2032 is automatically optimized and moves towards a state of lowest energy (minimum fluid resistance) or towards a state of maximum cross-sectional space (e.g., to accommodate and pass clot particles).
[0019] A system 400 for thrombus aspiration is shown in Figures 4-5. The aspiration catheter 406 is similar to the aspiration catheter 2018 of Figures 1-3. The aspiration catheter 406 can also be configured to aspirate thrombus from peripheral blood vessels, as well as sized to treat coronary, cerebral, pulmonary or other arteries or veins. The aspiration catheter 406 / system 400 may be used in interventional procedures, but may also be used in surgical procedures. The aspiration catheter 406 / system 400 may be used in vascular or non-vascular procedures (other body cavities, ducts, or cavities). The catheter 406 comprises an elongate shaft 423 configured to be disposed within a blood vessel of a subject, a catheter supply lumen 2093 ( FIG. 2 ) and a guidewire / aspiration lumen 2032, each extending along the shaft, the supply lumen 2093 having a proximal end 2011 and a distal end 2009, and the aspiration lumen 2032 having a proximal end 2005 ( FIG. 3 ) and an open distal end 2036 ( FIG. 2 ), and an orifice or opening 2081 at or near the distal end 2009 of the supply lumen 2093, the opening configured to allow injection of pressurized fluid into the aspiration lumen 2032 at or near the distal end 2036 of the aspiration lumen 2032 when the pressurized fluid is pumped through the supply lumen 2093. In some embodiments, the orifice or opening 2081 may be located near the distal end 2009 of the supply lumen 2093. In one embodiment, the distal end 2009 of the supply lumen 2093 may include a plug 2083. A pump set 404 (e.g., a tubing set) is configured to hydraulically connect the supply lumen 2093 to a pump within a saline drive unit (SDU) 411 for injecting pressurized fluid (e.g., saline, heparinized saline) through the supply lumen 2093. A suction tube 408, including a sterile suction tube 419 and a non-sterile suction tube 420, is configured to hydraulically connect the vacuum canister 407 to the suction lumen 2032.Filter 418 may be carried in-line with suction tube 408, for example between sterile suction tube 419 and non-sterile suction tube 420, or connected to non-sterile suction tube 420. Filter 418 is configured to capture larger elements, such as large pieces of thrombus or emboli.
[0020] The pump set 404 includes a saline spike 402 for connecting to a port 602 on the saline bag 401 and an in-line drip chamber 403 for visually assessing saline movement and keeping air out of the infused fluid. The saline bag 401 may be hung from an IV pole 405 on one or more hooks 608. A pressure sensor 604, such as a vacuum sensor, may be used within any lumen of the pump set 404, the suction tube 408, the supply lumen 2093 or the suction lumen 2032 of the catheter 406, or any other component where fluid flow can be seen. The pressure sensor 604 is within the lumen of the junction between the first suction tube 606 and the control device 409, as shown in FIG. 4. A cable 412 carries the signal output from the pressure sensor 604 to the controller 493 of the SDU 411. A connector 439 electrically connected to the cable 412 is configured to be removably coupled to a mating receptacle 492 (e.g., an input jack) of the SDU 411. The SDU 411 may also have a display 413 including an LCD screen or alternative screen or monitor for visually monitoring parameters and treatment status. In alternative embodiments, the pressure sensor 604 may be replaced with another type of sensor configured to characterize fluid flow. In one embodiment, the sensor is a flow sensor, such as a Doppler flow rate sensor.
[0021] Aspirant (e.g., clots, thrombus, blood) exiting the patient through the aspiration lumen 2032 is collected in a vacuum canister 407. The canister is held in a canister mount 421 supported by an IV pole 405 or any other part of the system 400. The vacuum canister 407 includes a receptacle 610 and a lid 612 configured to tightly cover a portion of the receptacle 610 to close an interior 676 of the receptacle 610. Alternatively, the lid 612 can be screwed, clipped, friction fit, or otherwise coupled to the receptacle 610. The SDU 411 is held to the mount 614 by four locking knobs 414. The mount 614 is secured to a telescoping rod 422 that is adjustable from the cart base 410 via a cart height adjustment knob or other element 417. The mount 614 and handle 415 are secured to the rod 422 via an inner post 616 that is insertable and securable within an interior cavity of the rod 422. The IV pole 405 is secured to the mount 614 via a connector 618. The base 410 includes legs 424 having wheels 425 (e.g., three or more wheels or four or more wheels) and is movable, for example, via the handle 415. The system 400 can also carry a basket 416 for placing components, products, manuals, or other items.
[0022] In use, a user connects a first connector 620 of a first end 624 of the suction tube 420 to a port 622 in the lid 612 of the canister 407 and a second connector 441 of a second end 626 of the suction tube 420 to a vacuum pump input 628 of the SDU 411. A vacuum pump 630 may be carried inside the SDU 411 to maintain a vacuum / negative pressure inside the canister 407. Alternatively, the vacuum inside the canister 407 may be maintained manually, without a vacuum pump, by evacuating the canister 407 through one or more additional ports 632. A user connects a first connector 440 of the sterile suction tube 419 to a suction luer 634 (similar to luer 2051) of the suction catheter 406 and a second connector 441 of the sterile suction tube 419 to a port 636 in the lid 612 of the canister 407. The connector 439 is then coupled to a mating receptacle of the SDU 411 for communicating with the controller 409 and / or the pressure sensor 604. For example, the connector 439 can be snapped into a mating receptacle 492 of the SDU 411 for communicating with elements of the controller 409 and / or with the pressure sensor 604 via the cable 412 and / or additional cables or wires. The controller 409 is configured to control the operation of the system and is described in more detail herein. Alternatively, the connector 439 may be coupled to the mating receptacle 492 by clipping, friction fitting, vacuum fitting, or other methods.
[0023] The user allows saline to be purged through the supply tube 638, cassette 642, and infusion tube 640 of the pump set 404, and then connects the luer connector 644 of the pump set 404 to the luer 646 of the suction catheter 406 (similar to luer 2055). The cassette 642 (similar to cassette 2016) is then attached to the saddle 648 of the SDU 411. The saddle 648 is configured to reciprocate a piston to infuse saline at high pressure from the IV bag 401 while keeping the contents (e.g., saline) sterile after the cassette 2016 is snapped into place. A system configured to perform this type of sterile injection of high pressure saline is described in U.S. Patent No. 9,883,877, entitled "Systems and Methods for Removal of Blood and Thrombotic Material," issued February 6, 2018, and incorporated by reference in its entirety for all purposes. The SDU 411 is housed inside the case 650 and case lid 652. The controller 493 may be on a circuit board 654. Noise from the motor 656 and vacuum pump 630 that control the saddle 648 is dampened by internal foam sections 658, 660. The saddle 648 may be moved directly by the motor 656 or may be moved pneumatically using cyclic pressurization. An interface panel 662 provides one or more switches 664 and a display 413. Alternatively, the cassette 2016 may be coupled to the saddle 648 by clip-on, friction fit, vacuum fit, or other methods.
[0024] 6-12 show a suction tube set 444 including a sterile suction tube 419 and a control device 409. The housing 443 includes a first housing half 426 and a second housing half 427, each configured to house multiple components and to close and attach to one another. The halves 426, 427 may be bonded together with adhesive, epoxy, or fused together with ultrasonic or solvent welding, or may be secured together with screws or other connecting elements. As shown in FIG. 6, the suction passage from the suction lumen 2032 of the suction catheter 406 extends from left to right. The first connector 440 may be a luer fitting configured to sealingly attach to the luer 2051. However, alternatively, the luer 2051 may be replaced by a barb and the first connector 440 may be a suction connector, for example a 22 French silicone suction connector. The first connector 440 is sealingly secured to a first end 445 of a first sterile suction tube 419a that extends at its second end 447 into an inlet 446 of the control device 409. The inlet 446 comprises a hole within an end cover 429 that is attached to the ends of the halves 426, 427. The second end 447 frictionally slides over a barb 599 of an elbow fitting 434 that includes an inner passageway 448 having a 90° bend 449. In some embodiments, the bend 449 may comprise an acute angle, such as an angle of about 10° to about 80°, or about 20° to about 70°, or about 30° to about 60°. The inner passageway 448 of the elbow fitting 434 has an inlet 450 and an outlet 451 (see FIG. 10). Surrounding the outlet 451 is a concave rounded surface 452 configured to sealingly join to a convex cylindrical surface 453 on a custom syringe barrel (piston cylinder) 437. An inlet orifice 454 originates at the surface 453 and passes through a wall 478 of the cylinder 437. In an embodiment, the elbow fitting 434 and the cylinder 437 may be monolithic. For example, they may comprise a single injection molded or 3D printed component (or using other additive manufacturing methods). A first end 457 of the second sterile suction tube 419b is friction fitted onto an outer cylindrical surface 455 of a hub 456 of the cylinder 437.In some embodiments, adhesive, epoxy, or welding can be used to seal the inner wall surface of tube 419b to the outer cylindrical surface 455, although a friction fit is sufficient to withstand a -1 vacuum atmosphere. In an alternative embodiment, hub 456 includes barbs. In a further alternative embodiment shown in Figures 11-12, first end 457 may be flared, glued, and / or wedged between halves 426, 427.
[0025] At the second end 458 of the tube 419b, a second connector 441 is sealingly joined. The second connector 441 may be a suction connector, for example a 30 French silicone suction connector. The second connector 441 may be configured to sealingly connect to a port of the canister 407, or to an intermediate tube that is then attached to the canister 407, or to a filter 418. Thus, a continuous contained suction passage 459 is formed from the first connector 440 to the second connector 441. As shown by the S-shaped arrow in FIG. 12, the passage 459 comprises an S-duct 460, which is formed by the combination of the suction tube 419a, the elbow fitting 434, the cylinder 437, and the suction tube 419b. The passage 459 is configured for transport of thrombus and blood from the suction lumen 2032 of the suction catheter 406 to the canister 407.
[0026] 11-12, the S-duct 460 provides an interior space for the valve 461 by sliding the plunger 433 supported by the piston body 432, thereby forming a piston 462 structure. The piston body 432 may comprise a rigid polymer, such as polyamide. FIG. 11 shows the valve 461 in a closed position, stopping flow through the passage 459, and FIG. 12 shows the valve 461 in an open position, allowing flow through the passage 459. The plunger 433 is snapped onto a barb 463 at a first end 464 of the piston body 432 and configured to move integrally with the piston body 432 within a cylindrical cavity 465 (FIG. 10) within the cylinder 437, the cylindrical cavity 465 (FIG. 10) having an interior volume. Alternatively, the plunger 433 may be coupled to the piston body 432 by threading, clipping, friction fitting, or other methods. The slider 430 includes a recess 466 for engaging a user's finger and includes a hole 467 (FIGS. 11-12) into which a first end 468 of the spring pin 436 frictionally engages. Alternatively, the spring pin 436 may be bonded into the hole 467. The spring pin 436 is configured to be slidable back and forth within an elongated slot 470 in the cylinder 437. A second end 469 of the spring pin 436 frictionally engages a hole 471 in the piston body 432. The housing 443 includes a handle 472 extending laterally therefrom and configured to be held or grasped (e.g., by a user's hand or one or more fingers) opposite the recess 466 of the slider 430. Thus, by moving the slider 430 relative to the housing 443 toward the handle 472, in the direction of arrow 666 molded or otherwise marked on face 669 of the first half 426, the piston body 432 is retracted, carrying the plunger 433 with it, thus changing the valve 461 from the closed position of FIG. 11 to the open position of FIG. 12.
[0027] The piston body 432 further includes a cantilever beam 473 extending longitudinally from a second end 474 of the piston body 432 and terminating in a free beam end 475 having a locking tab 476. When the valve 461 is in its open position, the locking tab 476 is configured to extend through a locking hole 477 in a wall 478 of the cylinder 437. With the valve 461 open, the negative pressure within the passage 459 attracts, and thus pulls, the plunger 433 (and thus the piston body 432) in a direction opposite to the arrow 666 on the first half 426 of the housing 443. Thus, in a feature best seen in FIG. 9, an endmost edge 479 of the locking tab 476 rests against a distal ledge 480 of the locking hole 477, maintaining and locking the valve 461 in the open position. The unlocking assembly 481, comprising the casing 482 and the button 431, is slidable within the cavity 668 of the handle 472 in a direction generally transverse to the longitudinal axis L of the cylinder 437 / piston body 432 (FIG. 8). A user can voluntarily unlock the piston body 432 from the cylinder 437 by pressing the button 431 in a direction D, causing the engagement pin 483 of the unlocking assembly 481 to press the locking tab 476 laterally inward (generally also in the direction D) while bending or deflecting the cantilever beam 473, thus moving the entirety of the locking tab 476 into the cylinder 437, fully releasing the locking bore 477 and no longer engaging the distal ledge 480. Thus, negative pressure within the passage 459 can now move the plunger 433 (and thus the piston body 432) in the direction opposite to the arrow 666, such that the valve 461 is forced closed. The plunger 433 sealingly presses against the inner annular edge 670 at the end of the cylinder 437. In this closed position, the locking tab 476 moves to a position adjacent the rest hole 484 (FIG. 9) and the spring memory of the cantilever beam 473 urges the locking tab 476 laterally (generally in the opposite direction D) through the rest hole 484. The negative pressure inside the passage 459 urges the plunger 433 / piston body 432 together with some compression of the material of the resilient plunger 433, which stops the extreme edge 479 of the locking tab 476 against the rest ledge 485, thus resting the piston body 432 in a single position with the valve 461 closed. Thus, flow through the passage 459 is blocked.A compression spring 496 may be carried on a shaft 497 below the button 431 to return the button 431 and unlocking assembly 481 to their original positions after the button 431 is depressed and then released.
[0028] The electrical switch 438 is carried within a groove 486 in the end cover 429 and includes a spring-loaded displaceable switch button 487. When the valve 461 is opened, the piston body 432 is slid toward the switch 438 such that an annular rim 488 of the second end 474 of the piston body 432 engages and moves against the switch button 487, thereby actuating the electrical switch 438. In some embodiments, actuation of the electrical switch 438 causes the pump of the SDU 411 to begin injecting pressurized fluid through the supply lumen 2093 of the catheter 406. In some embodiments, deactivation of the electrical switch 438 causes the pump of the SDU 411 to stop. Movement of the piston body in a direction in which the valve 461 is closed moves the annular rim 488 away from the switch button 487 to disengage, thereby shutting off the switch. In some embodiments, the electrical switch 438 may comprise a SPST-NO switch. Thus, the opening and closing of valve 461 and the on and off of the pump of SDU 411 are synchronized together by a combination of electrical and hydraulic switches provided by control device 409. In manual operation, a user opens valve 461 and turns on the pump of SDU 411 by moving slider 430. The user then closes valve 461 and turns off the pump of SDU 411 by pressing button 431. Controller 493 is configured to receive a signal from switch 438 and start (or stop) the pump of SDU 411 immediately or with a particular delay time.
[0029] Emergency shutoff is provided by a solenoid 435 inside the unlocking assembly 481 and a pressure sensor 428 configured to measure pressure inside the passageway 459. Turning to FIG. 10, the pressure sensor 428 includes a sensing portion 489 that is inserted through a hole 490 in the elbow fitting 434. The pressure sensor 428 and surrounding portions of the elbow fitting 434 are then sealed with epoxy, adhesive, or other means. The pressure sensor 428 can thus measure pressure inside the inner passageway 448 of the elbow fitting 434 and output a signal related to the measured parameter. Alternatively, the pressure sensor 428 (or another pressure sensor) can be configured to measure pressure at another location along the passageway 459, or even at the aspiration lumen 2032 of the catheter 406. The wire conduit 442 carries more or two or more conductors 491 that run parallel along the aspiration tube 419b. The conductors 491 may each comprise an insulated copper wire. Conductors 491 are configured to provide power and / or carry signals to and from pressure sensor 428, switch 438, and solenoid 435, as well as additional pressure sensor 604, if used. As mentioned above, at the second end 458 of tube 419b, conductors 491 terminate via an electrical connection to a modular plug connector 439 configured to snap-fit into a mating receptacle 492 of SDU 411 (FIG. 4). Connector 439 may be an eight-position eight-contact (8p8c) connector in one embodiment.
[0030] While the valve 461 is in the open position and the pump of the SDU 411 is operating (e.g., via the saddle 648), a malfunction can occur that causes a loss of negative pressure inside the passage 459. The user may not be aware that this has occurred, thus creating a potentially dangerous situation of injecting pressurized fluid without any suction. The pressure sensor 428 inputs to a controller 493 that is configured to recognize when an unacceptable pressure is being read (e.g., an insufficient level of vacuum). The controller 493 is configured to momentarily energize the solenoid 435, which causes the engagement pin 483 of the unlocking assembly 481 to telescopically extend from the solenoid 435, thus electromagnetically energizing the solenoid 435 to move the locking tabs 476 laterally inward (direction D), while deflecting the cantilever beam 473 and forcing the entire locking tabs 476 into the cylinder 437 and releasing the locking hole 477. This allows valve 461 to close and immediately shut off the pump of SDU 411, avoiding a potentially dangerous situation. A spring 494 and retaining ring 495 are shown in FIG. 9 and are configured to return engagement pin 483 to its non-extended position after controller 493 de-energizes solenoid 435. Other safety features relating to system shutdown or other automatic system responses may be utilized, such as those described in U.S. Pat. No. 10,716,583, entitled "Systems and Methods for Removal of Blood and Thrombotic Material," issued on July 21, 2020, U.S. Pat. No. 10,492,805, entitled "Systems and Methods for Thrombosis and Delivery of an Agent," issued on December 3, 2019, or U.S. Patent Application Publication No. 2018 / 0207397, entitled "Systems and Methods for Removal of Blood and Thrombotic Material," published on July 26, 2018, each of which is incorporated by reference in its entirety for all purposes.
[0031] Returning to FIG. 5, the solenoid 672 is carried inside the SDU 411 and configured to interface with the interior 676 of the canister 407 via the suction tube 408 or via any additional tube. The solenoid 672 is configured to vent the negative pressure inside the canister 407 by opening a valve 674 coupled (mechanically or electromagnetically) to the solenoid, which opens the interior 676 of the canister 407 to ambient pressure. Venting allows to reduce any foaming of blood or fluids, such as any aspirated liquid, inside the canister 407. If bubbles are formed, foaming may occur during the thrombolysis procedure due to cavitation. The solenoid 672 is then configured to close the valve 674, allowing the negative pressure to build up again in the interior 676 of the canister 407. The controller 493 is configured to automatically energize the solenoid 672 to allow degassing / defoaming. For example, the controller 493 may send a signal to energize the solenoid 672 based on a measurement of a target negative pressure and / or a target aspiration cycle time. In other cases, the controller 493 may send a signal to energize the solenoid 672 every minute, every five minutes, every ten minutes, etc. Additionally, a user may operate the controller 493, or more generally the controller 303, of the system 400 via the interface panel 662 to initiate degassing / defoaming of the interior 676. Venting may also remove air bubbles inside other lumens of the catheter and tubing set.
[0032] In one embodiment, the controller 493 outputs or sends a signal to energize the solenoid 672 and open the valve 674 to stop any suction, while still allowing the SDU 411 to deliver saline, a drug, or saline in combination with a drug (e.g., a thrombolytic drug) so that fluid can be pumped out the open distal end 2036 (instead of being aspirated through the suction lumen 2032).
[0033] 13-14 show an alternative control device 509, which generally includes the same components as control device 409, except for certain alternative or additional parts, including a modified piston body 532 and a modified cylinder 537. A cantilever beam 573 extends away from plunger 433, rather than toward it. Cantilever beam 573 is also on the opposite (e.g., lower) side 531 of cylinder 537 from slider 430, which is on top surface 533. Cantilever beam 573 is attached to cylinder 537 at its proximal end 535. Rest hole 584 and rest ledge 585, as well as locking hole 577 and distal ledge 580, are on the opposite side 531 of cylinder 537 from elongated slot 570, which is on top surface 533. Note: "upper" and "lower" are used in this case to indicate opposites and should not be considered as limiting the manner in which control device 509 is intended to be held. It may be held in multiple orientations depending on the user's preference. Meanwhile, in controller 409, annular edge 488 of second end 474 of piston body 432 engages and moves switch button 487 to activate electrical switch 438, and in controller 509, tip 598 of locking tab 576 moves switch button 487 when piston body 432 is moved towards switch 438. It should be noted that in either controller 409 or controller 509, any other structure or structures that allow for locking and unlocking may be used in place of cantilever beam 473, 573 with locking tabs 476, 576.
[0034] In a further alternative embodiment, controller 409 or controller 509 may be configured to be foot operated rather than manually. An exemplary foot pedal to accomplish this may also utilize features as described in U.S. Patent Application Publication No. 2018 / 0207397, published July 26, 2018, entitled "Systems and Methods for Removal of Blood and Thrombotic Material."
[0035] While the systems for thrombus aspiration described herein focus primarily on aspiration, the systems may also, or alternatively, be configured to introduce or inject fluids, with or without drugs, and may incorporate relevant features described in U.S. Pat. No. 10,716,583, issued July 21, 2020, and entitled "Systems and Methods for Removal of Blood and Thrombotic Material," and U.S. Pat. No. 10,492,805, issued December 3, 2019, and entitled "Systems and Methods for Thrombosis and Delivery of an Agent."
[0036] It is contemplated that various combinations or subcombinations of the specific features and aspects of the disclosed embodiments listed above may be made and still be included in one or more of the embodiments. Furthermore, any particular feature, aspect, method, property, attribute, quality, attribute, element, etc. disclosed herein in relation to an embodiment may be used in all other embodiments described herein. It is therefore understood that various features and aspects of the disclosed embodiments may be combined with or substituted for one another to form various modes of the disclosed embodiments. It is therefore intended that the scope of the disclosure disclosed herein should not be limited by the specific disclosed embodiments described above. Also, the disclosure is susceptible to various modifications and alternative forms, specific examples of which have been shown in the drawings and have been described in detail herein. However, it is to be understood that the disclosure is not limited to the particular forms or methods disclosed, but rather, the disclosure encompasses all modifications, equivalents, and alternatives falling within the spirit and scope of the various described embodiments and the appended claims. Any method disclosed herein does not have to be performed in the order recited. The methods disclosed herein include specific actions performed by the practitioner. However, they may also include, explicitly or implicitly, any third party direction of their operation.
[0037] The following clauses contain examples of devices of the present disclosure.
[0038] Clause 1: A system for thrombus aspiration, comprising an aspiration catheter including an elongate shaft configured for placement within a blood vessel of a subject, a supply lumen and an aspiration lumen each extending along the shaft, the supply lumen having a proximal end and a distal end, the aspiration lumen having a proximal end and a distal opening, and an opening at or near the distal end of the supply lumen configured to allow for infusion of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen when the pressurized fluid is pumped through the supply lumen, an extension conduit, a distal end configured to couple to the aspiration lumen of the aspiration catheter, and a negative conduit, 1. A system for thrombus aspiration comprising: an extension conduit including a proximal end configured to connect to a pressure source and a passage extending between a distal end and a proximal end of the extension conduit; a composite hydraulic-electrical control device carried on the extension conduit and including a first control interface and a control body, the first control interface configured to be actuated by a user to move the control body between a first position and a second position; an electrical switch configured to be actuated by the control body when the control body is moved to the second position; and a valve having a closed position that blocks flow through the passage of the extension conduit and an open position that allows flow through the passage of the extension conduit, the valve configured to be moved from the closed position to the open position by the control body when the control body is moved to the second position.
[0039] Clause 2: The system of clause 1, wherein the electrical switch is configured to be deactivated by the control body when the control body is moved away from the second position.
[0040] Clause 3: The system of clause 1, wherein the electrical switch is configured to, when actuated, cause the pump to pump pressurized fluid through the supply lumen.
[0041] Clause 4: The system of clause 3, wherein the electrical switch is configured to shut off the pump when deactivated.
[0042] Clause 5: The system of clause 3, further comprising a pump.
[0043] Clause 6: The system of clause 1, when the control body is configured to be locked in a second position.
[0044] Clause 7: The system of clause 6, further comprising a release control configured to unlock the control body so that it can be moved away from the second position.
[0045] Clause 8: The system of clause 7, wherein the release control device includes a solenoid.
[0046] Clause 9: The system of clause 7, further comprising a locking tab associated with the control body and displaceable in a direction generally transverse to the longitudinal axis of the control body.
[0047] Clause 10: The system of clause 9, wherein the locking tab is coupled to the control body via a deflectable beam.
[0048] Clause 11: The system of clause 10, wherein the deflectable beam extends in a direction substantially parallel to a longitudinal axis of the control body.
[0049] Clause 12: The system of clause 11, wherein the deflectable beam extends generally in a direction toward the valve.
[0050] Clause 13: The system of clause 11, wherein the deflectable beam extends generally in a direction away from the valve.
[0051] Clause 14: The system described in clause 7, wherein the release control device includes an operator touch-operated interface and a solenoid, the operator touch-operated interface configured to enable voluntary unlocking of the control body and the solenoid configured to effect automatic unlocking of the control body.
[0052] Clause 15: The system of clause 1, wherein the valve is configured to be pulled to a closed position by negative pressure within the passageway.
[0053] Clause 16: The system described in clause 1, wherein the control body includes a piston having a first end and a second end, the piston configured to sealingly slide within a cylinder having an internal volume.
[0054] Clause 17: The system of clause 16, wherein the valve includes a plunger carried on a first end of the piston.
[0055] Clause 18: The system of clause 17, wherein the valve is configured to be pulled to a closed position when a first pressure within the passage is lower than a second pressure within the cylinder adjacent the second end of the piston.
[0056] Clause 19: The system of clause 1, further comprising a sensor configured to measure a parameter related to fluid flow in the passageway and output a signal related to the measured parameter.
[0057] Clause 20: The system of clause 19, further comprising a controller configured to receive a signal from the sensor.
[0058] Clause 21: A system described in any one of clauses 1 or 2, wherein the electrical switch is configured to, when actuated, cause the pump to pump pressurized fluid through the supply lumen.
[0059] Clause 22: The system of clause 21, wherein the electrical switch is configured to shut off the pump when deactivated.
[0060] Clause 23: A system described in any one of clauses 21 or 22, further comprising a pump.
[0061] Clause 24: A system described in any one of clauses 1-2, or 21-23, wherein the control body includes a piston having a first end and a second end, the piston being configured to sealably slide within a cylinder having an internal volume.
[0062] Clause 25: The system of clause 24, wherein the valve includes a plunger carried on a first end of the piston.
[0063] Clause 26: A system described in any one of clauses 1 to 2, or 21 to 25, when the control body is configured to be locked in the second position.
[0064] Clause 27: A system described in any one of clauses 1-2, or 21-26, wherein the valve is configured to be pulled to a closed position by negative pressure within the passage.
[0065] Clause 28: The system of clause 24, wherein the valve is configured to be pulled to a closed position when a first pressure within the passage is lower than a second pressure within the cylinder adjacent the second end of the piston.
[0066] Clause 29: The system of clause 26, further comprising a release control device configured to unlock the control body so that it can be moved away from the second position.
[0067] Clause 30: The system described in clause 29, wherein the valve is configured such that when the control body is unlocked, the valve is pulled to a closed position if a first pressure within the passage is lower than a second pressure within the cylinder adjacent the second end of the piston.
[0068] Clause 31: A system as described in any one of clauses 29 or 30, wherein the release control device includes a manually operated interface.
[0069] Clause 32: A system as described in any one of clauses 29 or 30, wherein the release control device includes a foot operable interface.
[0070] Clause 33: A system as described in any one of clauses 29 or 30, wherein the release control device includes a solenoid.
[0071] Clause 34: A system as described in any one of clauses 29 or 30, wherein the release control device includes an operator touch operated interface and a solenoid.
[0072] Clause 35: A system as described in any one of clauses 29 to 34, further comprising a locking tab associated with the control body and displaceable in a direction generally transverse to the longitudinal axis of the control body.
[0073] Clause 36: The system described in clause 35, wherein the locking tab is coupled to the control body via a deflectable beam.
[0074] Clause 37: A system as described in clause 36, wherein the deflectable beam extends in a direction substantially parallel to a longitudinal axis of the control body.
[0075] Clause 38: The system of clause 37, wherein the deflectable beam extends generally in a direction toward the valve.
[0076] Clause 39: The system of clause 37, wherein the deflectable beam extends generally away from the valve.
[0077] Clause 40: A system described in any one of clauses 1-2, or 21-39, further comprising a pressure sensor configured to measure pressure in the passage and output a signal related to the measured pressure.
[0078] Clause 41: The system of clause 40, further comprising a controller configured to receive a signal from the pressure sensor.
[0079] Clause 42: A system described in any one of clauses 1-2, or 21-41, further comprising a flow sensor configured to measure a parameter related to the flow of fluid in the passage and output a signal related to the measured parameter.
[0080] Clause 43: The system described in clause 42, further comprising an operator touch operated interface and a solenoid, the operator touch operated interface and the solenoid being combined and configured such that the operator touch operated interface is configured for voluntary unlocking of the control body and the solenoid is configured for automatic unlocking of the control body.
[0081] Clause 44: The system described in clause 43, wherein the solenoid is configured for emergency shutdown of the system.
[0082] Clause 45: A system described in any one of clauses 1 to 44, wherein the extension conduit is configured to be supplied in a sterile state.
[0083] Clause 46: The system described in clause 1, further comprising a solenoid, the solenoid configured to open the vent valve to allow at least a portion of the aspirated liquid in fluid communication with the negative pressure source to be coupled to ambient air.
[0084] Clause 47: The system of clause 46, further comprising a controller configured to operate the solenoid.
[0085] Clause 48: An extension conduit for use with a thrombus aspiration system, comprising: a passage extending between a distal end and a proximal end of the extension conduit; and a composite hydraulic and electrical control device carried on the extension conduit and configured to be actuated by a user to activate an electrical switch while opening a valve to allow flow through the passage.
[0086] Clause 49: An extension conduit for use with a thrombus aspiration system, comprising: a passage extending between a distal end and a proximal end of the extension conduit; and a composite hydraulic and electrical control carried by the extension conduit and configured to be actuated by a user to deactivate an electrical switch while closing a valve to stop flow through the passage.
[0087] The ranges disclosed herein also encompass any and all overlaps, partial ranges, and combinations thereof. Expressions such as "up to," "at least," "greater than," "less than," "between," and the like include the recited numbers. As used herein, numbers preceded by terms such as "approximately," "about," and "substantially" include the recited numbers (e.g., about 10%=10%) and also represent amounts close to the recited amount that still perform the desired function or achieve the desired result. For example, the terms "approximately," "about," and "substantially" can refer to amounts within 10%, within 5%, within 1%, within 0.1%, and within 0.01% of the recited amount.
[0088] For purposes of this disclosure and the appended claims, the conjunction "or" is to be interpreted inclusively (e.g., "apples or oranges" is to be interpreted as "apples, or oranges, or both"; e.g., "apples, oranges, or avocados" is to be interpreted as "apples, oranges, avocados, or any two, or all three"); except (i) unless otherwise noted, e.g., by use of "either or," "only one of," or similar language, or (ii) where two or more of the listed alternatives are mutually exclusive in a particular context, in which case "or" encompasses only combinations that include the non-mutually exclusive alternatives. For purposes of this disclosure and the appended claims, the words "comprising," "including," "having," and variations thereof, whenever they occur, are to be interpreted as open-ended terms having the same meaning as if the phrase "at least" was attached after each instance thereof.
Claims
1. A system for thrombus aspiration, comprising:
1. A suction catheter comprising: an elongate shaft configured for placement within a blood vessel of a subject; a supply lumen and an aspiration lumen, each extending along the shaft, the supply lumen having a proximal end and a distal end, and the aspiration lumen having a proximal end and a distal opening; an opening at or near a distal end of the supply lumen configured to allow for injecting pressurized fluid into the aspiration lumen at or near a distal end of the aspiration lumen when pressurized fluid is pumped through the supply lumen; a suction catheter comprising: an extension conduit comprising: a distal end configured to couple to an aspiration lumen of the aspiration catheter; a proximal end configured to couple to a negative pressure source; and a passageway extending between the distal and proximal ends of the extension conduit; a combined hydraulic and electrical control device carried on the extension conduit and including a first control interface and a control body, the first control interface configured to be actuated by a user to move the control body between a first position and a second position, the control body configured to be locked in the second position; an electrical switch configured to be actuated by the control body when the control body is moved to the second position; a valve having a closed position blocking flow through the passage of the extension conduit and an open position allowing flow through the passage of the extension conduit, the valve being configured to be moved from the closed position to the open position by the control body when the control body is moved to the second position; A system for thrombus aspiration comprising:
2. The system of claim 1 , wherein the electrical switch is configured to be deactivated by the control body when the control body is moved away from the second position.
3. The system of claim 1 , further comprising a sensor configured to measure a parameter related to fluid flow in the passageway and to output a signal related to the measured parameter.
4. The system of claim 3 , further comprising a controller configured to receive a signal from the sensor.
5. A system according to any preceding claim, wherein the electrical switch is configured, when actuated, to cause the pump to pump pressurised fluid through the supply lumen.
6. The system of claim 6 , wherein the electrical switch is configured to shut off the pump when deactivated.
7. 7. The system of claim 5 or 6, further comprising a pump.
8. 5. The system of claim 1, wherein the control body comprises a piston having a first end and a second end, the piston configured to sealingly slide within a cylinder having an interior volume.
9. The system of claim 8 , wherein the valve comprises a plunger carried on a first end of the piston.
10. 9. The system of claim 8, wherein the valve is configured to be pulled to a closed position when a first pressure within the passage is less than a second pressure within the cylinder adjacent the second end of the piston.
11. A system according to any preceding claim, wherein the valve is configured to be pulled into a closed position by negative pressure within the passageway.
12. The system of claim 1 , further comprising a release control configured to unlock the control body so that it can be moved away from the second position.
13. 13. The system of claim 12, wherein the release control device comprises an operator touch-operated interface and a solenoid, the release control device being configured such that the operator touch-operated interface enables voluntary unlocking of the control body and the solenoid provides automatic unlocking of the control body.
14. 14. The system of claim 13, wherein the valve is configured such that when the control body is unlocked, the valve is pulled to a closed position if a first pressure within the passage is less than a second pressure within the cylinder adjacent the second end of the piston.
15. 15. A system as claimed in claim 13 or 14, wherein the release control comprises a manually operated interface.
16. 15. A system as claimed in any one of claims 13 or 14, wherein the release control comprises a foot operable interface.
17. 15. A system as claimed in any one of claims 13 or 14, wherein the release control device comprises a solenoid.
18. 15. A system as claimed in claim 13 or 14, wherein the release control comprises an operator touch operated interface and a solenoid.
19. The system of claim 1 further comprising a locking tab associated with the control body and displaceable in a direction generally transverse to the longitudinal axis of the control body.
20. The system of claim 19 , wherein the locking tab is coupled to the control body via a deflectable beam.
21. The system of claim 20 , wherein the deflectable beam extends in a direction generally parallel to a longitudinal axis of the control body.
22. The system of claim 21 , wherein the deflectable beam extends generally in a direction toward the valve.
23. The system of claim 22 , wherein the deflectable beam extends generally away from the valve.
24. The system of claim 1 , further comprising a pressure sensor configured to measure a pressure in the passageway and output a signal related to the measured pressure.
25. 25. The system of claim 24, further comprising a controller configured to receive a signal from the pressure sensor.
26. The system of any one of claims 1 to 4, further comprising a flow sensor configured to measure a parameter related to the flow of fluid in the passageway and to output a signal related to the measured parameter.
27. The system of claim 13 , wherein the solenoid is configured for emergency shutdown of the system.
28. A system according to any preceding claim, wherein the extension conduit is adapted to be supplied in a sterile condition.
29. 4. The system of claim 1, further comprising a solenoid, the solenoid configured to open a vent valve to allow at least a portion of the aspirated liquid in fluid communication with the negative pressure source to be coupled to ambient air.
30. 30. The system of claim 29, further comprising a controller configured to operate the solenoid.
31. 1. An extension conduit for use with a thrombus aspiration system, comprising: a passageway extending between the distal and proximal ends of the extension conduit; a combined hydraulic and electrical control carried on the extension conduit and configured to be actuated by a user to actuate an electrical switch while opening a valve to permit flow through the passageway; The extension conduit comprises:
32. 1. An extension conduit for use with a thrombus aspiration system, comprising: a passageway extending between the distal and proximal ends of the extension conduit; a combined hydraulic and electrical control carried on the extension conduit and configured to be actuated by a user to deactivate the electrical switch while closing the valve to stop flow through the passageway; The extension conduit comprises: