Aspiration thrombus removal system and method for removing thrombus with aspiration catheter

Abstract

A thrombus removal system includes a catheter having a distal end and defining a lumen filled with a fluid column having a proximal portion and a distal portion; a vacuum source; discharging the liquid source; and a vacuum and exhaust control system configured to cyclically connect or disconnect the vacuum source and the exhaust liquid source to vary the vacuum level at the distal end and substantially prevent forward flow. A vacuum source and an exhaust source are fluidly connected to the vacuum valve and the exhaust valve, respectively. A manifold connects the proximal portion to a vacuum source and an exhaust gas source through a valve. During each cycle, control of the valve prevents the distal portion from flowing forward from the distal end. Each cycle may have states including vacuum only, a first double-off, exhaust only, and a second double-off. And the time of the double-closing state is not longer than 30ms.

Description

Divisional Application Instructions

[0001] This application is a divisional application of the invention patent application with the application date of July 19, 2019, application number 201980061257.9, and invention name "Suction thrombus removal system and method for removing thrombus using suction catheter". Technical Field

[0002] The system, device and method of the present invention belong to the field of thrombus removal. The present disclosure relates to an aspiration thrombus removal system and a method for removing thrombus using an aspiration catheter. Background Art

[0003] Ischemic strokes are usually caused by a blood clot that blocks or obstructs a blood vessel in the brain. This blockage prevents blood from flowing to the brain. Within minutes, brain cells begin to die, which, if not treated quickly, will lead to brain damage or death. The costs associated with removing the clot are enormous. Most treatments involve thrombectomy: removing the clot by aspiration, mechanical retrieval, or a combination of both.

[0004] Suction removal is performed by placing a vacuum source (e.g., a suction or vacuum catheter) upstream of the clot and pulling the clot into or against the distal end of the catheter. Conceptually, suction is effective, but some major problems arise in practice. The basic construction of the suction catheter includes a hollow catheter of a certain length, the proximal fluid of which is connected to a vacuum pump or a suction pump. In this construction, the operation of the suction pump causes the fluid and particles at the distal end of the catheter to enter the distal opening of the hollow cavity and travel to the proximal end of the cavity close to or entering the suction pump. The conventional suction catheter thread passes through the balloon guide catheter. In an exemplary process, the balloon of the guide catheter is guided into the internal carotid artery of the brain. The balloon expands to block the blood vessel. The suction catheter thread passes through the balloon guide catheter and passes through the balloon to come out of the distal end of the guide catheter. The distal end of the suction catheter advances to the clot that blocks the cerebral blood vessel. The suction connected to the suction catheter is turned on to cause backflow. Ideally, the system would aspirate the clot entirely from the neurovasculature and into the proximal end of the aspiration catheter so that extraction and reestablishment of blood flow could be confirmed. However, in practice, this rarely occurs.

[0005] The diameter of the thrombus is usually larger than the diameter of the catheter used to aspirate the thrombus. In order for the aspiration to be successful, the thrombus must be deformed to conform to the inner diameter of the aspiration catheter. During conventional aspiration, the application of vacuum usually sucks the thrombus partially into the distal opening of the lumen of the aspiration catheter, thereby deforming some of the thrombus to the inner diameter of the catheter. At this point, the thrombus is completely retained, partially retained inside the aspiration catheter, or at the distal opening of the aspiration catheter, which can be called a blockage or plugging. In fact, the distal end becomes a suction cup grabber for the clot. When this happens, the surgeon's only option is to use the aspiration catheter as a fishing line to pull the clot back through the balloon catheter and out of the body. Another option is not feasible, that is, to reverse the aspiration to pressurize the clot and force it to be forcibly and uncontrolledly discharged from the distal opening of the aspiration catheter. This action is dangerous to the patient for many reasons, the main reason being that the forced and uncontrolled discharge of the clot may cause the clot to move further distally in the blood vessel where it was initially retained. This distal migration can not only cause the clot to be further within the vessel (i.e., smaller in diameter than when it was initially lodged), but can also permanently lodge the clot in the vessel, making it impossible to remove, or it can rupture the vessel. Those skilled in the art will appreciate that these situations should be avoided due to the serious potential risks to the patient.

[0006] Even if the surgeon uses a suction catheter to fish the clot out, there is no guarantee that all of the clot has been removed. Fragments of the clot may suddenly stop in their tracks, and when this happens, the fragments can re-embolize in the same vessel or in a different vessel, which can be more difficult to remove.

[0007] When all or most of a clot has been aspirated from a patient, it can be difficult to confirm that the entire thrombus has been removed. A significant disadvantage of current thrombus removal devices is that the surgeon is unable to determine capture / removal of a thrombus without completely withdrawing a given treatment device from the patient's anatomy. Even systems that are capable of completely aspirating a given thrombus are problematic because in an operating room environment, the container in which the aspirated contents are deposited is located outside the sterile field. This location outside the sterile field makes it difficult or impossible for the physician operating the aspiration catheter to easily visualize and assess the aspirated thrombotic material.

[0008] Confirmation of thrombus removal may require the surgeon to attempt aspiration again. The aspiration catheter and balloon guide catheter must be cleaned, distal anatomical access must be reestablished, and any embolic material remaining when the aspiration catheter is finally repositioned at the embolized site may re-create the same problem. The disadvantage of these procedures is that the operating time is significantly increased, which not only significantly increases costs (because every minute in the operating room is expensive), but also increases the surgeon's stress, thereby reducing the success rate of the procedure.

[0009] The first-pass recanalization rate is a metric used to determine the efficacy of a thrombectomy system. Most current systems provide rates between 30% and 60%. Systems that increase the first-pass recanalization rate are valuable and desirable.

[0010] Prior art systems cannot avoid positive pressure at the distal end of the catheter even when attempting to maintain vacuum pressure using manual periodic cycling. Prior art systems cannot react quickly enough to prevent the distal end of the catheter from being subjected to positive pressure. When positive pressure exists at the distal end of the cavity, liquid from inside the cavity flows out of the distal end of the catheter in the distal direction. This is called forward flow. The prior art does not have a fast enough reaction time to inhibit the forward flow. Therefore, the forward flow can and does remove the thrombus from the distal end and has the potential to transport the thrombus further distally in the vascular system. Such a system cannot ensure that all forward flow is removed to eliminate the positive pressure at the distal end of the catheter.

[0011]

[0006] Therefore, there is a need to overcome the system, design and process problems of the prior art as described above. Summary of the invention

[0012] The described systems, devices and methods provide an aspiration thrombectomy system and a method for removing thrombus using an aspiration thrombectomy system, overcoming the above-mentioned shortcomings of the heretofore known devices and methods of this general type, and providing a feature with an increased first-pass recanalization rate by completely pulling out the thrombus, thereby reducing the situation of thrombus clogging / blocking the aspiration catheter.

[0013] The system, apparatus and method provide an aspiration thrombectomy system that completely evacuates the clot so that it is no longer dragged out of the vasculature and hangs halfway out of the catheter tip. The aspiration thrombectomy system moves the vacuumed clot all the way to the proximal end of the vacuum channel and allows the surgeon to confirm the recanalization of the vessel where the clot was previously located (e.g., by injecting contrast media into the catheter left in place after the clot is removed) and provides a structure to indicate to the surgeon that the clot has been removed and blood flow has been restored.

[0014] The system, device and method provide an aspiration thrombectomy system that can be combined with a conventional aspiration catheter to significantly increase the efficacy of such a catheter and pump system. The vacuum level is indicated here in two different ways: 1) As absolute pressure levels, where "high vacuum" approaches zero absolute pressure. This is the "absolute pressure" way of measuring a vacuum. An ideal vacuum would be zero, and atmospheric pressure would be indicated by measuring the height of a column of mercury that could be supported by a standard atmosphere (760 mm Hg). Therefore, lower values ​​indicate an increased vacuum level relative to the surrounding atmospheric pressure. 2) It can indicate pressure relative to atmospheric pressure. This method of measuring pressure relative to standard atmospheric pressure is called "gauge pressure". The most common way to measure pressure in the vacuum range (below atmospheric pressure) is to use a gage that has been calibrated so that one atmosphere reads zero (standard atmospheric pressure) and the highest possible vacuum level is expressed as "29.92 inches of mercury". Ordinary mechanical vacuum gauges work in this way, so this usage has become common.

[0015] Throughout this document, "gauge pressure" is used as a method of indicating vacuum levels; i.e., "zero inches of mercury" refers to atmospheric pressure, with no suction at all. A high number (e.g., 25" Hg) means a high vacuum suction level. (The highest possible vacuum level measured in this manner would be 29.92" Hg). As used herein, "vacuum" is a condition below normal atmospheric pressure. In this application, the units of vacuum pressure are pounds per square inch ("PSI," "psi"), inches of mercury, or mmHg. Depending on the context in which the word vacuum is used, a "high" vacuum is referred to herein as a low pressure below atmospheric pressure. Vacuum also refers to negative pressure, with pressures above atmospheric pressure being referred to as positive pressures. However, in some cases, using the word "high" for pressure may mean a greater negative pressure, or a greater positive pressure, depending on the context. Similarly, using the word "low" or "lower" for pressure may mean a smaller negative pressure, or a smaller positive pressure, depending on the context.

[0016] The diameter of the thrombus is usually larger than the diameter of the catheter used to aspirate the thrombus. In order for aspiration to be successful, the thrombus must be deformed to conform to the inner diameter of the aspiration catheter. During conventional aspiration, the application of a vacuum often draws part of the thrombus into the distal opening of the aspiration catheter lumen. At this point, the thrombus is stuck, with some of the thrombus staying within the inner diameter of the catheter and some of the thrombus protruding distally.

[0017] These systems, devices and methods provide an aspiration thrombectomy system with a patent structure and a technique that can temporarily stop the vacuum at the distal end of the aspiration catheter, push the thrombus distally out of the lumen, and then reapply the vacuum - an occlusion-vacuum-pressure sequence of operations. After the vacuum is reapplied, the thrombus will accelerate back into the catheter and deform to a diameter that allows it to be completely aspirated. Each stop of the vacuum, pushing the thrombus and reapplying the vacuum is controlled by the surgeon.

[0018] The system and method use a mechanism to stop the vacuum to operate the suction / inhalation catheter, and then reversely press the distal fluid column, that is, a positive displacement in the absence of a check valve, referred to herein as column displacement. All functions can be controlled with one handle, including vacuum shutdown and column displacement, while limiting the amount and force of column displacement. When the controller is actuated, a positive outlet flow is generated without the possibility of overshoot. The outflow movement of the fluid is limited to a specific volume and / or pressure and is automatically and accurately controlled. It is the user who controls when column displacement occurs and when the column returns. A trap is provided at the outlet to capture and display thrombi. Ventilation can be opened to the atmosphere to clear the fluid in the trap and display how much thrombus remains.

[0019] In view of the foregoing and other purposes, a vacuum catheter for removing an object from a human blood vessel is provided, the vacuum catheter comprising a vacuum tube defining an internal vacuum channel and a vacuum interruption controller, the vacuum channel comprising a proximal opening for receiving a vacuum application and a distal capture opening fluidly connected to the proximal opening, the distal capture opening being configured to receive an object therein in response to the vacuum application, and the vacuum channel comprising an intermediate portion between the proximal opening and the distal capture opening, and the vacuum interruption controller comprising a main body and an extrusion compressor, a portion of the intermediate portion passing through the main body, the extrusion compressor being movably arranged relative to the main body toward and away from the portion of the intermediate portion, so that in a static state, the extrusion compressor does not block the vacuum channel, and in an actuated state, the extrusion compressor first blocks the vacuum channel and then moves the fluid disposed between the portion of the intermediate portion and the distal capture opening distally toward the distal capture opening a given distance.

[0020] According to another feature, a vacuum pump is provided for selectively applying a vacuum to the proximal opening.

[0021] According to yet another feature, the vacuum tube has a proximal portion and further includes a catheter body surrounding the vacuum tube and configured to guide at least the proximal portion of the vacuum tube.

[0022] According to an additional feature, the vacuum tube has a proximal portion sized to fit within a Circle of Willis in the brain, and the subject is a blood clot adjacent to the Circle of Willis.

[0023] In view of the foregoing and other purposes, a clot removal system is provided, the system comprising: a catheter having a distal end and defining a cavity filled with a liquid column having a proximal portion and a distal portion; a controllable vacuum valve; a vacuum source fluidly connected to the vacuum valve; a controllable exhaust valve having an exhaust liquid inlet; an exhaust fluid source containing exhaust liquid and fluidly connected to the exhaust valve to maintain the exhaust liquid at the exhaust fluid inlet; a manifold connected to the catheter, to the vacuum valve, and to the exhaust valve, the manifold fluidically connecting the proximal portion of the liquid column in the cavity to the vacuum source through the vacuum valve and to the exhaust fluid source through the exhaust valve; a controller connected to the vacuum valve and the exhaust valve and configured to selectively open and close the vacuum valve and the exhaust valve such that in response to opening the vacuum valve, the vacuum source fluid is connected to the liquid column in the cavity, and in response to opening the exhaust valve, the exhaust fluid source is fluidly connected to the liquid column in the cavity, the controller being configured to cyclically open and close the vacuum valve and the exhaust valve to change the vacuum level at the distal end during each cycle and prevent the distal portion from flowing forward from the distal end.

[0024] In view of these objects, there is also provided a clot removal system, the system comprising: a catheter having a distal end and defining a lumen filled with a column of liquid, the column of liquid having a proximal portion and a distal portion; a controllable vacuum valve; a vacuum source fluidly connected to the vacuum valve; a controllable exhaust valve having an exhaust liquid inlet; an exhaust fluid source containing exhaust liquid and fluidly connected to the exhaust valve to maintain the exhaust liquid at the exhaust liquid inlet; a manifold connected to the catheter, to the vacuum valve, and to the exhaust valve, the manifold connecting the proximal portion of the column of liquid in the lumen to the vacuum source through the exhaust valve fluid and to the exhaust fluid through the exhaust valve fluid a source; a controller connected to the vacuum valve and the exhaust valve and configured to selectively open and close the vacuum valve and the exhaust valve, such that in response to opening the vacuum valve, the vacuum source fluid is connected to the liquid column in the cavity, and in response to opening the exhaust valve, the exhaust fluid source is connected to the liquid column in the cavity, the controller being configured to cyclically open and close the vacuum valve and the exhaust valve in a repeating cycle including a double closed state (in which the vacuum valve is closed and the exhaust valve is closed) to change the vacuum level at the distal end during each cycle and prevent the distal portion from flowing forwardly out of the distal end, the double closed state being in a time period of no more than about 30 ms.

[0025] In view of these objectives, a clot removal system is also provided, comprising: a catheter having a distal end and defining a cavity filled with a liquid column having a proximal portion and a distal portion; a vacuum source; a venting liquid source; and a vacuum and venting control system configured to cyclically connect or disconnect the vacuum source and the venting liquid source to change the vacuum level at the distal end and substantially prevent forward flow.

[0026] In view of these objectives, a clot removal system is also provided, comprising: a catheter having a distal end and defining a cavity filled with a liquid column, the liquid column having a proximal portion and a distal portion; a vacuum source; a venting liquid source; and a vacuum and venting control system configured to cyclically fluidically connect vacuum from the vacuum source, venting liquid from the venting liquid source, and at least one of neither vacuum nor venting liquid to the proximal portion, thereby varying the vacuum level at the distal end and substantially preventing forward flow.

[0027] According to another feature, the controller is configured to cyclically open and close the vacuum valve and the exhaust valve in a repeating cycle including a double closed state in which the vacuum valve is closed and the exhaust valve is closed.

[0028] According to yet another feature, the time of the double-off state is no greater than 30 ms.

[0029] According to an added feature, the controller is configured to cyclically open and close the vacuum valve and the exhaust valve in a repeating cycle including an exhaust-only state in which the vacuum valve is closed and the exhaust valve is open.

[0030] According to an additional feature, the exhaust-only state is no longer than 50 ms.

[0031] According to another feature, the controller is configured to selectively open and close the vacuum valve and exhaust valve cycles in a repeating cycle including a vacuum-only state in which the vacuum valve is open and the exhaust valve is closed, a first double closed state in which the vacuum valve is closed and the exhaust valve is closed, an exhaust-only state in which the vacuum valve is closed and the exhaust valve is open, and a second double closed state in which the vacuum valve is closed and the exhaust valve is closed.

[0032] According to yet another feature, the time between opening of the exhaust valve and closing of the exhaust valve is between about 10 ms and about 50 ms.

[0033] According to yet another additional feature, the cycle has a period between about 6 Hz and about 16 Hz.

[0034] According to another additional feature, the period of the cycle is between about 8 Hz and 12 Hz.

[0035] Still according to another feature, the change in vacuum level at the distal end is greater than about 15 inHg in no more than about 50 ms.

[0036] According to yet another feature, the change in vacuum level at the distal end is greater than about 20 inHg and no greater than about 30 ms; and

[0037] Still according to another feature, the change in vacuum level at the distal end is greater than about 25 inHg and no greater than about 20 ms.

[0038] Again according to additional features, the inner diameter of the cavity is between about 0.038" and about 0.106", and the controller is configured to cyclically open and close the vacuum valve and the exhaust valve at a frequency of 2 to 16 Hz.

[0039] Still according to another feature, the inner diameter of the cavity is between about 0.068" and about 0.088", and the controller is configured to cyclically open and close the vacuum valve and the exhaust valve at a frequency between 2 and 16 Hz.

[0040] According to yet another feature, the controller is configured to cyclically open and close the vacuum valve and the exhaust valve in a repeating cycle and to prevent the distal portion from flowing forwardly out of the distal end during each cycle by adjusting the timing of the exhaust valve.

[0041] According to yet another feature, the controller is configured to cyclically open and close the vacuum valve and the exhaust valve to maintain a pressure level at the distal end that is less than a physiological pressure.

[0042] According to an accompanying feature, a shaft is provided on which the vacuum valve and the exhaust valve are mounted together.

[0043] The operation of the ROAR procedure described below is successful in removing clots for two reasons. First, the ROAR effect overcomes the static friction of the clot that is fixed or "stuck" to the end of the catheter under constant suction. The ROAR procedure provides an oscillating / alternating displacement that "shuttles" the clot back and forth to overcome the static friction. Second, there is a comminution of the clot, overcoming different clot morphologies and overcoming the volume and diameter constraints of the small and fixed luminal volume dictated by the microanatomical environment.

[0044] The systems and methods described and illustrated herein react fast enough to prevent the pressure at the distal end from becoming positive. By cycling the vacuum valve and the exhaust valve at a sufficiently fast rate, pressure measurements were taken at the distal end of the catheter lumen at a rate of one thousand samples per section, demonstrating that the distal end of the ROAR catheter did not experience positive pressure and substantially eliminated forward flow. The time between operating the vacuum valve and the exhaust valve can be adjusted so that physical mechanisms that would cause positive pressure at the distal end can be avoided in both the open flow state and the plugged state.

[0045] According to an exemplary embodiment, the distal portion of the liquid column exiting the distal end is limited to no more than about 2 microliters.

[0046] According to an exemplary embodiment, a clot removal system includes: a catheter having a distal end and defining a cavity filled with a liquid column, the liquid column having a proximal portion and a distal portion; a vacuum source; an exhaust fluid source containing an exhaust liquid; and a vacuum and exhaust control system configured to cyclically fluidly connect and disconnect at least one of a vacuum from the vacuum source and an exhaust fluid from the exhaust fluid source to the proximal portion, thereby changing the vacuum level at the distal end and substantially preventing the distal portion of the liquid column from leaving the distal end.

[0047] According to an exemplary embodiment, a clot removal system includes: a catheter having a distal end and defining a cavity filled with a fluid column having a proximal portion; and a vacuum and exhaust control system configured to cyclically connect and disconnect vacuum and exhaust fluids to the proximal portion to generate forward flow pressure pulses therein, thereby generating reverse flow in the fluid column and substantially preventing the forward flow pressure pulses from reaching the distal end.

[0048] According to an exemplary embodiment, a clot removal system includes: a catheter having a distal end and defining a cavity filled with a liquid column, the liquid column having a proximal portion; and a vacuum and exhaust control system configured to cyclically connect and disconnect vacuum and exhaust fluids to the proximal portion to generate a forward flow pressure pulse therein, and to generate a reverse flow in the liquid column before the forward flow pressure pulse reaches the distal end, thereby substantially preventing the forward flow pressure pulse from reaching the distal end.

[0049] According to an exemplary embodiment, a clot removal system includes: a catheter having a distal end and defining a cavity filled with a liquid column, the liquid column having a proximal portion; and a vacuum and exhaust control system configured to cyclically connect and disconnect vacuum and exhaust fluids to the proximal portion, thereby allowing the liquid column to move and stop to generate a forward flow pressure pulse therein, and before the forward flow pressure pulse reaches the distal end, alternately control to generate a reverse flow in the liquid column, thereby controlling the forward flow pressure pulse by substantially preventing the forward flow pressure pulse from reaching the distal end.

[0050] According to an exemplary embodiment, the controller is configured to vary the vacuum level at the distal end in a cycle while preventing distal fixation of the distal portion of the liquid column.

[0051] According to an exemplary embodiment, the controller is configured to selectively open and close the vacuum valve and exhaust valve cycle in a repeating cycle, the repeating cycle including: a first state in which the vacuum valve is open and the exhaust valve is closed; a second state in which the vacuum valve is closed and the exhaust valve is closed; a third state in which the vacuum valve is closed and the exhaust valve is open; and a fourth state in which the vacuum valve is closed and the exhaust valve is closed.

[0052] According to an exemplary embodiment, a clot removal system includes: a catheter defining a cavity filled with a liquid column from a proximal portion to a distal end; and a water hammer controller configured to alternately connect a vacuum and / or a fluid at atmospheric pressure, body pressure, or lower pressure to the cavity, thereby causing the liquid column to move and stop to form a water hammer therein, and before the water hammer reaches the distal end, perform alternating control to produce a reverse flow, thereby controlling the water hammer by substantially preventing the water hammer from reaching the distal end.

[0053] According to an exemplary embodiment, a clot removal system includes: a catheter having a lumen, a vacuum source, a controllable vacuum valve, an exhaust fluid source, a controllable exhaust valve, a manifold connected to the catheter, to the vacuum valve, and to the exhaust valve, and a controller that controls the vacuum valve and the exhaust valve.

[0054] According to an exemplary embodiment, the controller is configured to regulate the vacuum valve and the exhaust valve in a cycle such that in response to a vacuum applied to the catheter, the compliance of the catheter causes the volume to decrease so that when the vacuum valve is closed and the exhaust valve is opened, the compliance acts as a spring and the cavity absorbs the exhaust liquid in the distal direction, and before the momentum caused by the absorbed liquid reaches the distal end of the catheter, the controller regulates the valve to reverse the flow direction of the fluid and eliminate the movement of the fluid, and prevent the fluid from flowing out of the distal end of the catheter.

[0055] According to an exemplary embodiment, a clot removal system includes: a catheter having a cavity; a substantially incompressible connecting tube having an internal cavity, the connecting tube having a proximal end and a distal end connected to the cavity fluid; a vacuum source; and a vacuum / exhaust manifold, which includes a manifold chamber having an output port fluidly connected to the proximal end, a vacuum line fluidly connected to the manifold and the vacuum source to provide vacuum from the source to the manifold chamber, and an exhaust line fluidly connected to the manifold and a liquid bath at atmospheric pressure.

[0056] According to one exemplary embodiment, a clot removal system includes a fixed cycle having a plurality of pinch valves and a plurality of cams mechanically coupled to the valves such that the direction of the cams cannot be changed.

[0057] According to an exemplary embodiment, the forward flow pulse is eliminated for a time not greater than about 20 ms.

[0058] According to an exemplary embodiment, a clot removal system includes a pulsating vacuum controller configured to alternately connect a vacuum and / or a fluid at atmospheric pressure / body pressure / slightly below body pressure / slightly above body pressure to a cavity, thereby allowing a liquid column to move and stop to generate a forward flow pressure pulse therein, and to control the forward flow pressure pulse by substantially preventing the forward flow pressure pulse from reaching the distal end (alternately controlled to generate a reverse flow before the forward flow pressure pulse reaches the distal end).

[0059] Although the systems, devices, and methods shown and described herein are embodied in an aspiration thrombectomy system and method for removing thrombi using an aspiration catheter, it is not intended to be limited to the details shown, as various modifications and structural changes may be made without departing from the spirit of the invention and within the purview and scope of equivalents of the claims. In addition, well-known elements of the exemplary embodiments will not be described in detail or will be omitted so as not to obscure the relevant details of the systems, devices, and methods.

[0060] Additional advantages and other features of the systems, devices and methods will be set forth in the following detailed description and may become apparent from the detailed description or may be learned by the practice of the exemplary embodiments. Other advantages of the systems, devices and methods may be achieved by any of the tools, methods or combinations specifically indicated in the claims.

[0061] Other features that are considered to be characteristic of the systems, devices, and methods are set forth in the appended claims. Detailed embodiments of the systems, devices, and methods are disclosed herein as needed, however, it should be understood that the disclosed embodiments are merely examples of systems, devices, and methods that can be presented in various forms. Therefore, the specific structural and functional details disclosed herein should not be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching a person of ordinary skill in the art to adopt the systems, devices, and methods of the present invention differently with almost any appropriate detailed structure. In addition, the terms and phrases used herein are not intended to be limiting; rather, they provide an understandable description of the systems, devices, and methods. Although the specification concludes with claims defining the systems, devices, and methods of the present invention that are considered to be novel, it is believed that the systems, devices, and methods will be better understood by considering the following description in conjunction with the drawings. The same figure numerals continue to be used in the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0062] In the accompanying drawings, the same reference numerals in all individual views refer to the same or functionally similar elements, these individual views are not drawn to scale and are incorporated into and constitute a part of the specification together with the detailed description below, and these drawings are used to further illustrate various embodiments and explain various principles and advantages, all of which are based on systems, devices and methods. The advantages of the embodiments of the systems, devices and methods will be apparent from the following detailed description of exemplary embodiments, which description should be considered in conjunction with the accompanying drawings, in which:

[0063] Figure 1 is a partial perspective view of an exemplary embodiment of a controller for a thrombectomy aspiration catheter in an unactuated state;

[0064] Figure 2 yes Figure 1 A partial perspective longitudinal section view of a controller;

[0065] Figure 3 yes Figure 1 an enlarged schematic side elevation view of a compression cam assembly of a controller;

[0066] Figure 4 yes Figure 1 A partial longitudinal cross-sectional view of a controller with the compression roller removed;

[0067] Figure 5 is in the actuated state Figure 1 A partial longitudinal sectional view of a controller;

[0068] Figure 6 yes Figure 1 A partial enlarged perspective view of a portion of an extrusion compressor of a controller;

[0069] Figure 7 is in the actuated state Figure 1 A partial perspective view of the controller;

[0070] Figure 8 yes Figure 7 A partial perspective view and a partial longitudinal cross-sectional view of a controller;

[0071] Fig. 9 It is in the intermediate actuation state Figure 8 A partial perspective longitudinal cross-sectional view of a controller of wherein a compression roller blocks the suction conduit and partially rolls to cause displacement of the liquid column;

[0072] Fig.10 yes Fig. 9 A partial longitudinal sectional view of a controller;

[0073] Fig.11 is in the actuated state Figure 1A partial perspective longitudinal cross-sectional view of a controller of wherein a compression roller blocks the suction conduit and is fully rolled to cause movement of the liquid column;

[0074] Fig.12 yes Fig.11 A partial longitudinal sectional view of a controller;

[0075] Fig.13 yes Fig. 9 A longitudinal cross-sectional view of a controller with the compression rollers and suction duct removed.

[0076] Fig.14 is in an unactivated state and schematically connected to the distal portion of the aspiration catheter Figure 1 A partial perspective longitudinal cross-sectional view of a controller of the present invention, wherein a thrombus is lodged in a distal opening of a vacuum channel;

[0077] Fig.15 is in the actuated state Fig.12 A partial perspective longitudinal cross-sectional view of a controller of wherein the post is displaced to dislodge a thrombus distally from a distal opening of a vacuum channel;

[0078] Fig.16 yes Figure 1 An enlarged partial perspective longitudinal cross-sectional view of an exemplary embodiment of a distal portion of a controller and a vacuum booster disposed between the controller and a distal extent of an aspiration catheter, wherein the vacuum booster is in an energized state;

[0079] Fig.17 yes Fig.16 A partial enlarged perspective longitudinal cross-sectional view of a controller and a vacuum booster, wherein the vacuum booster is in a relaxed state;

[0080] Fig.18 yes Figure 1 A partially enlarged perspective, partially transparent view of an exemplary embodiment of a proximal portion of a controller and a thrombus trap;

[0081] Fig.19 yes Fig.18 A partial enlarged perspective view of a controller and a thrombus trap, wherein the intermediate housing of the thrombus trap is removed;

[0082] Fig. 20 yes Fig.18 A partial enlarged perspective view of a controller and a thrombus trap;

[0083] Fig.21 yes Fig.16 The controller and Fig.18 A partial perspective longitudinal cross-sectional view of a thrombus trap;

[0084] Fig. 22is a partial longitudinal cross-sectional view of an exemplary embodiment of a volume change controller;

[0085] Fig.23 is a vacuum circuit diagram of an exemplary embodiment of a vacuum booster and a vacuum booster control device;

[0086] Fig.24 is a cyclic flow chart of the operation of an exemplary embodiment of a controller having a vacuum booster and a thrombus trap;

[0087] Fig.25 is a perspective view of an automated aspiration thrombectomy system to be connected distally to an aspiration catheter and proximally to a vacuum and exhaust line, with the cam housing removed;

[0088] Fig.26 yes Fig.25 A partial top view of the aspiration thrombectomy system, wherein the aspiration catheter and the vacuum line and exhaust line are schematically shown;

[0089] Fig. 27 yes Fig.25 A proximal front view of the aspiration thrombectomy system;

[0090] Fig.28 yes Fig.25 A front view of the bearing side of the suction thrombectomy system;

[0091] Fig.29 yes Fig.25 A perspective longitudinal cross-sectional view of the aspiration thrombectomy system, wherein the vacuum valve is in a closed state, the exhaust valve is in an open state, and the mark of the position reset assembly is in a zero reset state;

[0092] Fig.30 yes Fig.29 A longitudinal cross-sectional view of the aspiration thrombectomy system;

[0093] Fig.31 yes Fig.25 An enlarged cross-sectional view of a valve and cam assembly of an aspiration thrombectomy system, wherein the cam is in a rotational position to set an intermediate closure of the valve;

[0094] Fig.32 yes Fig.31 An enlarged cross-sectional view of a valve and cam assembly of the embodiment of the present invention, wherein the cam is in a rotational position to close the valve;

[0095] Fig.33 is along Fig.30 The section line 33-33 is taken Fig.25 A cross-sectional view of the aspiration thrombectomy system with the cam housing removed;

[0096] Fig.34 yes Fig.25 A perspective view of the aspiration thrombectomy system with the motor assembly housing removed;

[0097] Fig.35 yes Fig.26 A top view of the aspiration thrombectomy system with the motor assembly housing removed;

[0098] Fig.36 yes Fig. 27 A front view of the aspiration thrombectomy system with the motor assembly housing removed;

[0099] Fig.37 yes Fig.28 A front view of the bearing side of the aspiration thrombectomy system with the motor assembly housing removed;

[0100] Fig.38 Is a cam housing Fig.25 A perspective view of the aspiration thrombectomy system;

[0101] Fig.39 Is a cam housing Fig.26 A top view of the aspiration thrombectomy system;

[0102] Fig.40 Is a cam housing Fig. 27 Front view of the suction thrombectomy system;

[0103] Fig.41 Is a cam housing Fig.28 A front view of the bearing side of the suction thrombectomy system;

[0104] Fig.42 is a partial perspective view of an exemplary embodiment of a rotational pintle valve to be used with an aspiration thrombectomy system in a first valve state;

[0105] Fig.43 yes Fig.42 A partial cross-sectional view of a valve;

[0106] Fig.44 yes Fig.42 A perspective view of a valve with a partially hidden portion;

[0107] Fig.45 It is in the second valve state Fig.42 A perspective view of a valve with a partially hidden portion;

[0108] Fig.46 yes Fig.45 A partial cross-sectional view of a valve;

[0109] Fig.47is a schematic cross-sectional view of an exemplary embodiment of an aspiration thrombectomy system;

[0110] Fig.48 It is designed to operate using the ROAR process to calm pressure pulses. Fig.47 A diagram of an exemplary embodiment of a waveform of a system;

[0111] Fig.49 It is shown Fig.47 A diagram of an exemplary embodiment of one cycle of waveform operation of the vacuum valve and exhaust valve of the system;

[0112] Fig.50 It is shown that Fig.49 Waveform operation Fig.47 a graph of pressure curves at proximal and distal portions of a lumen of a catheter of a system;

[0113] Fig.51 is to show that they are combined in time Fig.49 and 50 A graph of the waveform of

[0114] Fig.52 It is designed to operate using the ROAR process to calm pressure pulses. Fig.47 A diagram of an exemplary embodiment of a waveform of a system;

[0115] Fig.53 It is shown Fig.47 A diagram of the vacuum valve and exhaust valve positions of the system for tuning the valves to produce the ROAR effect;

[0116] Fig.54 is used for Fig.47 A partial longitudinal cross-sectional view of a proximal manifold connector assembly of the system;

[0117] Fig.55 is a block diagram of an exemplary embodiment of a self-contained aspiration thrombectomy system;

[0118] Fig.56 An exemplary embodiment of a proximal manifold connector assembly having a remote control Fig.55 The block diagram of the system;

[0119] Fig.57 is a perspective view of an exemplary embodiment of a self-contained aspiration thrombectomy system with a collection canister and a vented liquid reservoir schematically indicated;

[0120] Fig.58 yes Fig.57 A partial perspective view of a box connection assembly of the system;

[0121] Fig.59 yes Fig.57 A top view of the system;

[0122] Fig.60 yes Fig.57 Left side view of the system;

[0123] Fig.61 yes Fig.57 Right side view of the system;

[0124] Fig.62 is a perspective view of an exemplary embodiment of a self-contained aspiration thrombectomy system, schematically showing a collection canister and a suspended vented liquid reservoir;

[0125] Fig.63 yes Fig.62 Left side view of the system;

[0126] Fig.64 yes Fig.62 Right side view of the system;

[0127] Fig.65 yes Fig.62 A top view of the system;

[0128] Fig.66 yes Fig.57 A front view of the system;

[0129] Fig.67 yes Fig.57 A partial front perspective view of a cartridge connection assembly and a suspended exhaust liquid reservoir of the system;

[0130] Fig.68 yes Figures 57 to 67 A top view of an exemplary embodiment of a valve cassett of a system of FIG. 1 , wherein a view of fluid chamber tubing is hidden;

[0131] Fig.69 yes Fig.69 A bottom plan view of a valve box;

[0132] Fig.70 yes Fig.69 A bottom perspective view of a valve box;

[0133] Fig.71 yes Fig.69 A bottom perspective view of the valve box; and

[0134] Fig.72 is a schematic diagram of an exemplary embodiment of a self-contained aspiration thrombectomy system. DETAILED DESCRIPTION

[0135] As required, detailed embodiments of systems, devices, and methods are disclosed herein; however, it should be understood that the disclosed embodiments are merely examples of systems, devices, and methods that may be presented in various forms. Therefore, the specific structural and functional details disclosed herein should not be interpreted as limiting, but merely as the basis for the claims, and are a representative basis for teaching those skilled in the art to use the systems, devices, and methods in various ways with almost any appropriately detailed structure. In addition, the terms and phrases used herein are not intended to be limiting; rather, they provide an understandable description of the systems, devices, and methods. Although the specification concludes with claims that define features of systems, devices, and methods that are believed to be novel, it is believed that the systems, devices, and methods can be better understood by considering the following description in conjunction with the accompanying drawings, in which the same reference numerals continue to be used.

[0136] In the following detailed description, reference is made to the accompanying drawings which form a part thereof, and in which embodiments that can be practiced are shown by way of illustration. It should be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope. Therefore, the following detailed description should not be considered restrictive, and the scope of the embodiments is defined by the appended claims and their equivalents.

[0137] Alternate embodiments may be devised without departing from the spirit or scope of the present invention. Additionally, well-known elements of exemplary embodiments of systems, devices, and methods will not be described in detail or will be omitted to avoid obscuring the relevant details of the systems, devices, and methods.

[0138] Before disclosing and describing system, device and method, it should be understood that the term used herein is only for the purpose of describing specific embodiment, rather than restrictive.Term " comprise ", " comprise " or any other variant thereof is intended to cover non-exclusive inclusion, makes the process, method, article or device including a series of elements not only include those elements, but can include other elements that are not clearly listed or inherent to such process, method, article or device.In the absence of more restrictions, the element starting with " comprise ... one / kind " does not exclude the existence of other identical elements in the process, method, article or device including the element.Term " comprise " and / or " have " used herein are defined as including (that is, open language).As used herein, term " one / kind " is defined as one / kind or more than one / kind.Term " multiple / kind " used herein is defined as two / kind or more than two / kind.As used herein, term " another " is defined as at least second or more.This description can use term " one or more embodiments ", it can refer to one or more in the same or different embodiments respectively.

[0139] The terms "coupled" and "connected" and their derivatives may be used. It should be understood that these terms are not intended to be equivalent to each other. Instead, in certain embodiments, "connected" may be used to indicate that two or more elements are in direct physical or electrical contact with each other. "Coupled" may mean that two or more elements are in direct physical or electrical contact (e.g., directly coupled). However, "coupled" may also mean that two or more elements are not in direct contact with each other, but still cooperate or interact with each other (e.g., indirectly coupled).

[0140] For purposes of this description, a phrase in the form "A / B" or in the form "A and / or B" or in the form "at least one of A and B" means (A), (B), or (A and B), where A and B are variables representing specific objects or attributes. When used, the phrase is intended to and is thereby defined as a selection of either A or B or both A and B, similar to the phrase "and / or". In the event that there are more than two variables in this phrase, the phrase is defined herein to include only one variable, any one variable, any combination of any variables, and all variables, e.g., a phrase in the form "at least one of A, B, and C" means (A), (B), (C), (A and B), (A and C), (B and C), or (A, B, and C).

[0141] Relational terms such as first and second, top and bottom, etc. may be used only to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. The description may use perspective-based descriptions, such as up / down, back / front, top / bottom, and proximal / distal. Such descriptions are only used to facilitate discussion and are not intended to limit the application of the disclosed embodiments. Various operations may be described as multiple discrete operations in a manner that facilitates understanding of the embodiments; however, the order of description should not be interpreted as implying that the operations are sequentially related.

[0142] As used herein, the term "about" or "approximately" applies to all numerical values, whether or not explicitly stated. These terms generally refer to a numerical range that a person skilled in the art would consider to be equivalent to the value (i.e., having the same function or result). In many cases, these terms may include numbers rounded to the nearest significant figure. As used herein, the terms "substantially" and "substantially" refer to that when the various parts are compared to each other, the compared parts are equal in size or close enough that a person skilled in the art would consider the same. As used herein, substantially and substantially are not limited to a single size, and specifically include the range of values ​​for those parts compared. The range of values ​​above and below (e.g., "+ / -" or more / or less or larger / smaller) includes changes in reasonable tolerances for the parts that a person skilled in the art would know.

[0143] It will be understood that embodiments of the systems, devices, and methods described herein may consist of one or more conventional processors and unique stored program instructions that control one or more processors to implement some, most, or all of the functions of the systems, devices, and methods described herein in combination with certain non-processor circuits and other elements. Non-processor circuits may include, but are not limited to: signal drivers, clock circuits, power supply circuits, and user input and output elements. Alternatively, some or all of the functions may be implemented by a state machine without stored program instructions, or implemented in one or more application specific integrated circuits (ASICs) or field programmable gate arrays (FPGAs), where each function or a combination of certain functions is implemented as custom logic. Of course, combinations of these methods may also be used. Therefore, methods and devices for these functions have been described herein.

[0144] As used herein, the terms "program", "software", "software application", etc. are defined as a sequence of instructions designed to be executed on a computer system or programmable device. A "program", "software", "application", "computer program", or "software application" may include subroutines, functions, procedures, object methods, object implementations, executable applications, applets, mini-applications, source code, object code, any computer language logic, shared libraries / dynamically loaded libraries, and / or other sequences of instructions designed to be executed on a computer system.

[0145] Various embodiments of systems, devices, and methods are described herein. In many different embodiments, features are similar. Therefore, in order to avoid redundancy, these similar functions may not be described repeatedly in some cases. However, it should be understood that the description of the first appearing feature is applicable to similar features described later, and therefore, each corresponding description will be incorporated therein without such repetition.

[0146] Exemplary embodiments will now be described. Figures 1 to 13 , shows a first exemplary embodiment of a single-hand controller 10 of an aspiration thrombectomy system 1 using a vacuum tube 2. The controller 10 includes a first handle portion 20 and a second handle portion 40. The first handle portion 20 is connected to the vacuum tube 2 and holds the vacuum tube 2, and is therefore also referred to as a handle base. The second handle portion 40 moves relative to the first handle portion 20, and is therefore also referred to as a compressor-actuator 40.

[0147] In one exemplary embodiment, the first handle portion 20 has a distal tube anchor 22 and a proximal tube anchor 24. In this embodiment, the distal tube anchor 22 and the proximal tube anchor 24 are in the form of a hollow tube through which the vacuum tube 2 passes. The distal tube anchor 22 and the proximal tube anchor 24 retain the vacuum tube 2 in the hollow tube without substantially compressing the vacuum tube 2 (and thereby without reducing or closing the vacuum passage 3 inside). The vacuum tube 2 can be made of many materials, including: latex, silicone, Polyurethane, polyvinyl chloride or other synthetic rubber. Exemplary dimensions of the vacuum tube 2 have an inner diameter (ID) of approximately 0.055 to 0.095 inches. One exemplary embodiment for holding the vacuum tube 2 is an adhesive that bonds the material of the vacuum tube 2 to the inner lumen of the tubular tube anchors 22, 24. In this exemplary embodiment, the vacuum tube 2 is secured to the first handle portion 20. In an alternative embodiment, the first handle portion 20 is a flip-top having two first handle portion halves (not shown) that open to receive the cylindrical vacuum tube 2, and when closed, the tube anchors 22, 24 tightly grasp the vacuum tube 2 therein without substantially closing or sealing the vacuum passage 3 of the vacuum tube 2. In an exemplary flip-top embodiment, the first handle portion 20 is Figure 2 The dotted lines in the figure are separated horizontally by hinges, thereby allowing a portion of the vacuum tube 2 to be inserted into or removed from the distal tube anchor 22 and the proximal tube anchor 24. The lock secures the vacuum tube 2 therein until the user wishes to remove it. The hinge can be used to allow the surgeon to reposition the controller 10 along the vacuum tube 2.

[0148] Exemplary embodiments of the distal and proximal tubular anchors 22, 24 are spaced a distance from one another. Between the distal and proximal tubular anchors 22, 24 of the first handle portion 20 is a compression base plate 26. When installed in the first handle portion 20, the vacuum tube 2 is placed against the compression base plate 26 between the distal and proximal tubular anchors 22, 24 without substantially closing or blocking the vacuum channel 3. Fig.13 The compressed base plate 26 of the first handle portion 20 is shown with the vacuum tube 2 removed.

[0149] The first handle portion 20 has a hollow interior that defines a set of parallel side walls 32 on either side of the vacuum tube 2. The first handle portion 20 includes a compression cam assembly 30 that allows the second handle portion 40 to move in two directions relative to the first handle portion 20. More specifically, in the exemplary embodiment, the compression cam assembly 30 includes a set of slots 34 formed in the side walls 32 of the first handle portion 20. Figure 3As shown in the enlarged view of FIG. 3 , these slots 34 have a vertical range 35 and an inclined range 36. The vertical range 35 has a vertical length, and the inclined range 36 has a vector length consisting of a second vertical range 37 and a horizontal range 39. Accordingly, as described below, the slots 34 provide a cam surface for moving the second handle portion 40 in the same shape as the slots 34.

[0150] In an exemplary embodiment, in order to bring the first handle portion 20 and the second handle portion 40 into contact with each other, the second handle portion 40 has a hollow interior into which the first handle portion 20 is inserted and protrudes. (In an alternative embodiment, the first handle portion 20 has a hollow interior into which the second handle portion 40 is inserted and protrudes.) The width between the inwardly facing side surfaces of the hollow compartment of the second handle portion 40 is approximately equal to the width of the outer surface of the side wall 32, so that the second handle portion 40 can move up and down on the first handle portion 20 closely but smoothly with little or substantially no friction. In contrast, the length between the inwardly facing longitudinal surfaces of the hollow compartment of the second handle portion 40 is greater than the length of the outer surface of the longitudinal wall 38. The difference in length is long enough to allow the second handle portion 40 to move along the horizontal range 39 parallel to the longitudinal direction of the vacuum tube 2 throughout the horizontal range 39.

[0151] The movement of the compressor-actuator 40 relative to the handle base 20 follows the slots 34 by providing the compressor-actuator 40 with bosses 42 that protrude from the inside of the hollow compartment of the compressor-actuator 40 facing the side wall 42; one circular boss 42 is associated with each slot 34. In this way, the movement of the compressor-actuator 40 is guided and limited by the shape of the slots 34. Figure 1 , 2 In the non-actuated state of the controller 10 shown in FIGS. 4 and 5 , the boss 42 is located at the end of the vertical range 35. In the exemplary embodiment, the boss 42 is located at the uppermost end of the slot 34. (Note that Figures 1 to 13 The illustrated embodiment provides four slots 34 and four bosses 42. This number is exemplary only. The boss surfaces of the slots 34, the ranges 35, 36 of the slots 34, and the cam followers of the bosses 42 may take any form or shape that enables the controller to operate as described herein. Figure 4 As best seen in FIG. 1 , the distance A between the interior of the proximal longitudinal wall 38 of the compressor-actuator 40 and the exterior of the proximal wall of the first handle portion 20 is longer than the horizontal extent 39 (i.e., |A|>|39|). Figure 5When the compressor-actuator 40 is shown fully actuated, the boss 42 has traveled to the opposite (lowest) end of the slot 34. Thus, the compressor-actuator 40 has traveled a vertical distance equal to the vertical movement of the boss 42 within the vertical range 35 and the tilt range 36, and has traveled a horizontal distance equal to the horizontal range 39. In the exemplary embodiment of the first handle portion 20 and the second handle portion 40, the inner surface of the distal longitudinal wall of the compressor-actuator 40 contacts the outer surface of the distal longitudinal wall of the handle base 20, and the contact is Figure 4 denoted by arrow B in (i.e., |B|=0). Therefore, when the compressor-actuator 40 is fully actuated, the distance between the two distal longitudinal walls is equal to the horizontal range 39. Similarly, the distance between the outer surface of the proximal longitudinal wall of the handle base 20 and the inner surface of the proximal longitudinal wall of the compressor-actuator 40 is shortened from A to a length equal to the horizontal range 39 (i.e., (A-|39|)), as shown in FIG. Figure 5 Alternatively, a four-bar linkage may be provided to connect 20 and 40 to produce the same motion as the cam slot and boss.

[0152] It is apparent from the movement of the compressor-actuator 40 following the slot 34 how the extrusion compressor 50 connected to the compressor-actuator 40 operates during this movement. Figure 1 , 2 In the exemplary embodiment of the extrusion compressor 50 in 4 to 13, the extrusion compressor 50 protrudes downward from the inner surface of the ceiling of the hollow compartment of the compressor-actuator 40 toward the handle base 20. In particular, the extrusion compressor 50 protrudes downward toward the compression floor 26 of the handle base 20. The extrusion compressor 50 has a base 52 attached to the second handle portion 40. A flexible arm 54 protrudes from the base 52 and extends toward the compression floor 26. In the exemplary embodiment, the flexible arm 54 is thinner than the base 52. The material from which the base 52 and the flexible arm 54 are made is not substantially rigid, and therefore, in response to the downward movement causing a portion of the extrusion compressor 50 to contact the compression floor 26 before the entire vertical movement of the compressor-actuator 40 is completed, the flexible arm 54 flexes. Example materials for the base 52 and the flexible arm 54 include: ABS, polycarbonate and Polypropylene, polyurethane or other thermoplastics or thermoplastic elastomers and / or fiber-filled ABS, polycarbonate and At the distal end of the flexible arms 54 is a gear flange 56 shaped to hold therein a compression roller 60. The gear flange 56 has an axial hole in which the shaft 62 of the compression roller 60 is located. When the compression roller 60 is mounted between the inner sides of the gear flanges 56, the compression roller 60 is fixed to the gear flange 56 in all directions except for rotational movement of the compression roller 60 about the axis of rotation 64 of the roller 60; in other words, the roller 60 is allowed to rotate about the axis 64.

[0153] Note that the extrusion compressor 50 shown is an exemplary embodiment. Different mechanical structures that perform the same function may be used. For example, the base 52 and the flexible arm 54 may be replaced by a single beam that is hinged to the ceiling of the interior cavity of the compressor-actuator 40 and biased toward the compression base plate 26 by a biasing device (e.g., a spring) so that the compression base plate 26 is not compressed. Figure 2 The points at which the compression rollers 60 are shown contact the vacuum tube 2 are sufficient to grip the vacuum tube 2 but do not substantially reduce the cross-sectional area of ​​the vacuum passage 3 .

[0154] The rotation of the roller 60 depends on how the roller 60 moves toward and along the vacuum tube 2. In this regard, the compression roller 60 has an outer contact surface 66 that contacts the vacuum tube 2 in various ways when the compressor-actuator 40 moves toward the handle base 20. Figure 6 As shown, the longitudinal cross-section of the outer surface 66 is approximately nautilus-shaped (alternatively, the shape may be cylindrical). The outer surface 66 has a contact point 67, Figure 2 In the unactuated state of the compressor-actuator 40 shown, this contact point 67 is in contact with the outer surface of the vacuum tube 2 (the vacuum channel 3 is not blocked and has a substantially open cross section). As the compressor-actuator 40 is actuated, the compressor-actuator 40 travels along the vertical range 35. This moves the contact point 67 toward the compression floor 26. When the compressor-actuator 40 has traveled along the entire vertical range 35, as shown in FIG. Figure 7 and 8 As shown, the contact point 67 moves against the vacuum tube 2 to completely block the vacuum channel 3. At the stage where the boss 42 is at the transition point from the vertical range 35 to the inclined range 36, the contact point 67 moves as far as possible toward the compression floor 26 as it moves in this direction, because the thickness of the vacuum tube 2 prevents the contact point 67 from moving further toward the compression floor 26.

[0155] In the procedure of thrombus removal using vacuum tube 2, vacuum channel 3 will be filled with fluid, i.e., blood. When vacuum channel 3 is completely blocked, the blood filling vacuum channel 3 from contact point 67 of compression roller 60 to the far side of vacuum channel 3 defines a column of fluid, which is incompressible. Controller 10 is configured to apply extrusion compressor 50 and compression roller 60 to move the fluid column in the distal direction by a displacement distance 70. An exemplary volume of the displacement distance is about 0.001ml to about 1.0ml, in particular about 0.1ml to about 0.5ml. An exemplary length of displacement distance 70 is about 0.5mm to about 30mm, in particular about 0.5mm to about 15mm. In order to achieve this movement, compressor-actuator 40 moves further in the direction toward handle base 20, which means that boss 42 travels along tilt range 36 and passes the end of tilt range 36. Because the contact point 67 is already as far as it can go in that direction (i.e., when the boss 42 is at the transition point from the vertical range 35 to the inclined range 36), the extruder compressor 50 has no other way to move except to bend the flexible arm 54 and / or to roll the compression roller 60. The contact surface 66 of the compression roller 60 is shaped to roll against the upper surface of the vacuum tube 2 (at Figure 2 and Figures 8 to 12 counterclockwise in the . Fig. 9 and Fig.10 The rolling of the compression roller 60 is shown to begin at a point where the boss 42 is within the inclined range 36, approximately halfway from the distal end of the slot 34. (Note that the generated Figures 9 to 12 ) The contact point 67 of the compression roller 60 is offset from the axis of rotation 64 toward the contact surface 66. This creates an over center or toggle so that the initial rolling motion of the compression roller must first force the contact point 67 past the center of the axis of rotation 64. In such a construction, not only does the compression roller 60 roll as the boss 42 of the compressor-actuator 40 begins to travel in the tilt range 37, but there is also tactile feedback transmitted to the compressor-actuator 40 as the shaft 62 moves slightly forward. When the user feels this feedback, the feedback indicates to the user that the contact surface 66 of the compression roller 60 has rolled over a portion of the vacuum tube 2 and as it moves along the vacuum tube 2, it is squeezing that portion to translate the fluid column in the distal direction of the vacuum tube 2. As shown in FIG. Fig.11 and 12As shown, as the compressor-actuator 40 is fully moved toward the handle base 20, the compression roller 60 has completed its limited rotation above the vacuum tube 2, and in doing so, a section of the vacuum channel 3 has been squeezed a certain length from the proximal side to the distal side to displace the liquid column distally to a length equal to the displacement distance 70.

[0156] In order to return the controller 10 to Figure 1 and 2 In the initial, unactuated state shown, for example, the biasing device 12 is inserted between any surface of the interior hollow of the compression-actuator 40 and any surface of the interior hollow of the handle base 20. Figure 2 and 8 In the exemplary embodiment shown, the biasing device 12 is disposed between the surface of the ceiling within the interior hollow of the compression-actuator 40 and the upper surface of the proximal tube anchor 24. This configuration of the biasing device 12 is merely exemplary, and any return spring or similar mechanical device may be placed and used. When the user releases pressure on the compression-actuator 40, the flexible arm 54 and / or the biasing device 12 return the compression-actuator 40 to its initial, unactuated state. This action causes the compression roller 60 to roll in the opposite direction (i.e., from the compression roller 60 to the compression roller 60). Figure 11 to Figure 9 arrive Figure 8 Since the distal end of the vacuum channel 3 is subjected to the positive pressure of the patient and the positive pressure generated by the volume increase of the crushed tube rebound, the fluid column retreats proximally into the vacuum channel 3, and when the compression roller 60 is released from the vacuum tube 2 to stop blocking the vacuum channel 3, the vacuum pump 80 from the proximal side of the controller 10 and the vacuum placed in the vacuum channel 3 are automatically re-established and the fluid column is sucked through the section of the vacuum tube 2 in the controller 10.

[0157] As described herein, the vacuum tube 2 is sized to be placed against the compression floor 26 on one side with the point contact of the compression roller 60 to the outer surface of the vacuum tube 2 just slightly enough to clamp the vacuum tube 2 but not substantially reduce the cross-sectional area of ​​the vacuum passage 3. In embodiments where the vacuum tube 2 is not fixed within the handle base 20, the compression roller 60 is provided with a biasing device, not shown, which rotationally biases the compression roller 60 to Figure 2 This offset is compensated in the case where the vacuum tube 2 is not in contact with the compression roller in the unactuated position of the compressor-actuator 40 .

[0158] With the described construction, the controller 10 is to be used with the vacuum tube 2 as or as part of a thrombus removal aspiration catheter. Fig.14 and 15Such use is described, wherein a vacuum chamber 3 is shown as an aspiration controller, which spirals through the vasculature distally of the controller 10 until a thrombus 4 in the form of a blood clot is lodged in or at the distal opening of the vacuum channel 3. On the proximal side of the controller 10, the vacuum channel 3 is fluidly connected to a vacuum pump 80. As described above, thrombi are often captured at the end of the aspiration catheter, and the entire catheter is removed from the patient when the situation is not ideal. The inventors have discovered that the use of the controller 10 can prevent the removal of the catheter. More specifically, when the distal end of the vacuum tube 2 is blocked by a thrombus, the controller 10 is actuated to block all flow through the vacuum channel 3. This occurs when the compressor-actuator 40 is first moved toward the handle base 20. The controller 10 is actuated to displace the fluid column distally to a displacement distance 70. This imparts a controlled reverse flow to the fluid column within the vacuum channel 3, which causes the thrombus to be slightly translated distally relative to the distal opening of the vacuum channel 3 to a specified displacement distance 70. In the third and final stage, the user releases the actuation of the controller 10 to reset the fluid column within the vacuum channel 3 and allow the fluid to flow freely again. The inventors have discovered that this movement causes the repositioning of the thrombus or the deformation of the thrombus or both, and that this movement allows the thrombus to fully enter and pass through the vacuum channel 3, where such passage was previously impossible.

[0159] about Fig.24 The system cycle diagram illustrates the operation of the controller 10.

[0160] State 1: Normal suction is taking place. The vacuum channel 3 is not blocked. The controller 100 is in a static state, with the vacuum pump 80 connected to the vacuum channel 3.

[0161] Transition A—Occlusion: Thrombus 4 blocks the distal end of vacuum channel 3. Unblock controller 10 actuates to block vacuum channel 3 and stop vacuum flow distal to controller 10.

[0162] State 2: Flow through vacuum channel 3 has stopped.

[0163] • Transition B - Unblocked: Controller 10 continues to actuate to induce reverse flow in vacuum channel 3 for metered volume column displacement.

[0164] State 3: Flow reversal stops.

[0165] • Transition C—Return Column Displacement: By reconnecting the vacuum pump 80 to the vacuum channel 3, the controller 10 reverses to return the column and accelerate the thrombus 4 into the catheter tip.

[0166] Return to state 1 and repeat: normal aspiration occurs.

[0167] The inventor further found that the greater acceleration of the thrombus into the catheter provides a proportionally faster suction. The impact speed of the thrombus and therefore the size of its kinetic energy (when it affects the distal end of the suction catheter) will affect the amount of thrombus that is deformed to fit the diameter of the vacuum channel 3. When the catheter is extended to the thrombus stuck in the blood vessel (e.g., the blood vessel in the brain), the controller 10 is not required until the thrombus 4 is stuck at the distal opening of the vacuum channel 3. Therefore, the thrombus has no distance to move to accelerate towards the opening of the vacuum channel 3. The described thrombus displacement distance maximizes the kinetic energy of the thrombus when the thrombus hits the end of the catheter. The acceleration of the thrombus (and therefore its kinetic energy) is generated by the pressure difference between the intracranial pressure and the effective suction pressure at the end of the catheter. In order to accelerate the thrombus, it and the fluid column in the catheter system must reach a certain speed. After the catheter is blocked, the fluid speed in the catheter is basically zero. In the traditional catheter structure, the pressure that attempts to accelerate the fluid column is provided only by an external vacuum pump. However, it is worth noting that the pressure is reduced by the head loss in the pipeline connecting the vacuum pump to the proximal end of the catheter. Therefore, conventional catheters must be completely withdrawn from the vessel because the thrombus becomes blocked within the distal opening of the vacuum channel.

[0168] This shortcoming is eliminated by the controller 10. After the distal opening of the vacuum channel 3 is blocked by a thrombus, the fluid velocity in the catheter is essentially zero. The controller 10 is used to clear the vacuum channel 3 and expel the thrombus 4 from the distal opening to the distal side. Then, the controller 10 reapplies the vacuum. After the vacuum is reapplied, the fluid column is accelerated, and the thrombus 4 is accelerated back into the vacuum channel 3. Under such acceleration, the thrombus is deformed to a diameter that can be aspirated. With one or only a few applications to displace the thrombus by the controller 10 a displacement distance of 70, the vacuum channel 3 becomes unobstructed, and the thrombus 4 is sufficiently accelerated to pass through and be completely aspirated out of the vacuum tube 2. Using the controller 10, the head loss of the pipeline is minimized, thereby allowing the thrombus to be accelerated to a much greater extent than conventional product structures.

[0169] Recognizing that proximal acceleration of the thrombus is a desired characteristic, acceleration in the proximal direction may be enhanced when the controller 10 deactuates to reestablish the vacuum. In order to maximize the acceleration of the thrombus and fluid column within the vacuum channel 3, the thrombus is accelerated as it collides with the distal end of the vacuum tube 2. Fig.16The vacuum booster 100 shown is fluidly connected to the vacuum channel 3 of the vacuum tube 2. Generally, the vacuum booster 100 applies suction to the fluid column in the area proximal to the suction catheter to maximize the acceleration of the fluid column of the catheter at a time selected by the user. This exemplary embodiment of the vacuum booster 100 includes a booster body 110 defining a plunger hole 112, a plunger 120 accommodated in the hole 112, and a biasing device 130. The plunger hole 112 is formed to define a vacuum chamber 114 and an ambient chamber 116. In an exemplary embodiment, the vacuum chamber 114 is cylindrical and has a first inner diameter, and the ambient chamber 116 is cylindrical and has a second inner diameter greater than the first inner diameter. The volume of the vacuum chamber 114 is smaller than the volume of the ambient chamber 116.

[0170] The plunger 120 has a vacuum piston 122 and an environmental piston 124, and the environmental piston 124 is connected to the vacuum piston 122 by a rod 123. In the exemplary embodiment, the vacuum piston 122 has a diameter substantially equal to the first inner diameter of the vacuum chamber 114 and is movable in the vacuum chamber 114. The environmental piston 124 has a diameter substantially equal to the second inner diameter of the environmental chamber 116 and is movable in the environmental chamber 116. There is a pressure chamber 118 between the vacuum piston 122 and the environmental piston 124, and a rod 123 (e.g., in the shape of an asymmetric dumbbell) connecting the two pistons 122, 124 together is located in the pressure chamber 118. In order to seal the pressure chamber 118 from both the vacuum chamber 114 and the environmental chamber 116, a vacuum seal 126 is provided between the vacuum piston 112 and the wall of the vacuum chamber 114, and an environmental seal 128 is arranged between the environmental piston 124 and the wall of the environmental chamber 116. The booster body 110 defines a pressure chamber 118 and a pressure port 119 that fluidly connects the pressure chamber 118 to a boost control valve or switch 150. This connection Fig.23 Medium picture.

[0171] The vacuum chamber 114 is operably connected to the vacuum channel 3 at the connection 140. The plunger 120 and the biasing device 130 are arranged so that when the biasing device 130 is in a relaxed state, the vacuum piston 122 is at a given distance from the connection 140 to the vacuum channel 3; the relaxed state is Fig.17 In the relaxed state, the spring is in a stable state - there is no potential energy stored in the spring. With respect to pressure, in the relaxed state, both the pressure chamber 118 and the environmental chamber 116 are at ambient pressure, i.e., they are substantially equal. When the plunger 120 moves toward the vacuum channel 3 into the energized state (eg, Fig.16As shown in FIG. 1 , the biasing device 130 (e.g., in the form of a stretched spring) thereby stores strain energy that is directed to move the plunger 120 away from the connecting piece 140. When this movement occurs, it generates suction within the vacuum chamber 114 and the vacuum channel 3 communicating with the vacuum chamber 114.

[0172] To actuate the pneumatically actuated vacuum booster 100 embodiment, the pressure chamber 118 is connected to the vacuum pump 80 (vacuum source) via a relatively high impedance conduit 152. The pressure chamber 118 is also connected to a boost control valve 150, which is connected to ambient pressure but is normally open to prevent flow from the pressure chamber 118 to the environment (Patm). When the vacuum booster 100 is in a cocked state ( Fig.16 ), the boost control valve 150 opens (as shown), and thus, the vacuum pump 80 is able to significantly reduce the pressure within the pressure chamber 118. When the boost control valve 150 is actuated (i.e., connecting the pressure chamber 118 to the ambient environment), pressure equalization occurs between the pressure chamber 118 and the ambient chamber 116. The impedance of the connection between the pressure chamber 118 and the boost control valve 150 is designed to be substantially less than the impedance between the pressure chamber 118 and the vacuum pump 80, so that rapid pressure equalization can be achieved when the boost control valve 150 is actuated (i.e., closed).

[0173] about Fig.24 The system cycle diagram illustrates the operation of the vacuum booster 100.

[0174] State 1: Normal suction is occurring. The vacuum channel 3 is not blocked. The controller 100 is in a stationary state with the vacuum pump 80 connected to the vacuum channel 3. The vacuum booster 100 is in an erected state. The thrombus trap 200 is operating without exhaust purge.

[0175] Transition A—Occlusion: Thrombus 4 blocks the distal end of vacuum channel 3. Unblock controller 10 is activated to block vacuum channel 3 and stop vacuum flow distal to controller 10.

[0176] State 2: Flow through vacuum channel 3 has stopped.

[0177] • Transition B - Unblocked: Controller 10 continues to actuate to induce reverse flow in vacuum channel 3 for metered volume column displacement.

[0178] State 3: Flow reversal stops.

[0179] Transition C—Vacuum Assist: The vacuum booster 100 is actuated to restart flow in the nominal direction and accelerate the thrombus 4 into the catheter tip. Shortly before, simultaneously, or shortly after, the controller 10 opens the vacuum channel 3 to restart the vacuum pump 80 to allow fluid flow and draw the thrombus 4 into the thrombus trap 200. At the same time or thereafter, the thrombus trap 200 is purged in a controlled or automated manner to allow inspection of the thrombus 4.

[0180] Return to state 1 and repeat: vacuum booster 100 and self-cleaning trap 200 deactivated. Normal suction occurs.

[0181] During the blocking and column displacement phases in the operation of the controller 10, the plunger 120 remains in an energized state, and the plunger 120 is raised to bring the vacuum piston 122 closer to the connector 140. During the reversing phase or immediately following the end of the reversing phase, the plunger 120 is released, generating suction in the local communication cavity of the vacuum channel 3, thereby accelerating the liquid column proximally in the vacuum direction. The fluid that is initially pulled into or toward the vacuum chamber has an impact on the efficiency of the vacuum booster 100. More specifically, if the fluid arrives only from the downstream of the vacuum booster 100 when the vacuum booster 100 is actuated, the fluid column will not be accelerated proximally as desired. When the controller 10 blocks the vacuum channel 3, the fluid entering and toward the vacuum chamber 114 will arrive substantially from the upstream of the vacuum channel 3, thereby accelerating the fluid column in the desired direction. In the intermediate stage where the fluid arrives from both the upstream and downstream, the downstream portion can be restricted, for example, by placing a non-shown check valve between the thrombus trap 200 and the connector 140, in particular between the connector 140 and the controller 10. The check valve can be external, or the blocking function of the unblocking handle can be used.

[0182] The following description summarizes the forces in a pneumatic embodiment of the vacuum booster 100. In the unerupted state of the plunger 120, the pressure chamber 118 and the ambient chamber 116 are at ambient pressure and the biasing device 130 is essentially in a relaxed state, thereby storing little or no strain energy. In the erected state of the plunger 120, the boost control valve 118 causes the pressure in the pressure chamber 118 to be significantly lower than the pressure in the ambient chamber 116. The geometry of the chambers 114, 116, 118 and the pistons 122, 124 and the characteristics of the biasing device 130 are selected so that in this construction, the force generated by the pressure differential across the ambient (larger) piston is significantly greater than the force required to expand the spring. In this way, when a given pressure is maintained, the piston and spring system transitions upward to the "erupted" position. When the vacuum booster 100 is actuated, the pressure chamber 118 is allowed to quickly equalize to the ambient pressure. With no net force input from the ambient piston 124 (the larger of the two pistons), any movement of the piston and spring system is now caused by the action of the biasing device 130 and the pressure differential across the smaller vacuum piston 122. The geometry of the chambers 114, 116, 118 and pistons 122, 124, and the characteristics of the biasing device 130 are selected so that in the erected configuration the restoring force of the biasing device is much higher than the opposing force caused by the pressure differential across the smaller vacuum piston 122, which is set between ambient pressure and the pressure in the vacuum passage 3. Thus, when the vacuum booster 100 is actuated and the pressure chamber 118 is allowed to equalize with ambient pressure, the piston and spring system drives "downward" as best it can, thereby producing a negative displacement and a significant pressure drop within the vacuum chamber 114, and hence within the vacuum passage 3 of the suction device.

[0183] As shown herein, current thrombus removal devices are unable to inform the surgeon that a thrombus has been removed without completely withdrawing the device from the patient's anatomy. The surgeon is unable to view the reservoir where the aspirated contents are deposited, not only because the reservoir is located outside the sterile field of the operating room environment, but also because the removed thrombus is present within the bulk of the blood contained in the reservoir.

[0184] In order to overcome the inability to visualize the actual retrieval of the thrombus, a visualization-assisted thrombus trap 200 is provided and Figures 18 to 21 . The thrombus catcher 200 is placed in line with the aspiration system, in particular the vacuum channel 3. In an exemplary embodiment, the thrombus catcher 200 is near the catheter operator, between the aspiration catheter and the vacuum source, in particular between the controller 10 and the vacuum pump 80, so that the surgeon can see the thrombus catcher 200 when using the controller 10. In use, all aspirated material flows through the thrombus catcher 200.

[0185] The thrombus trap 200 includes: a container having an inflow portion 210 having an input orifice 212 fluidly connected to the vacuum channel 3; a transparent intermediate trap portion 220 in which thrombi are trapped; and an outflow portion 230 fluidly connected to the vacuum pump 80. In operation, aspirated material and fluid travel from the vacuum channel 3 through the inflow portion 210 and into the trap portion 220 via the controller 10. The trap portion 220 contains a trap filter 222, which in an exemplary embodiment is a screen or filter through which all aspirated flow must pass. The filter 222 is configured to block and capture thrombus material therein, but allow air and fluid to pass with minimal impedance, thereby flowing out of the outflow portion 230 to the vacuum pump 80 and any associated vacuum pump reservoir 82. In Figures 18 to 22 In an exemplary embodiment of the invention, the filter 222 is in the form of a grid or screen having apertures large enough for fluid and air to pass therethrough, but small enough to substantially prevent thrombi from traversing the filter 222 from the inflow or trap chamber 224 of the trap portion 220 to the outflow chamber 226 of the trap portion 220. As used herein, the term "filter" includes any structure capable of separating fluid from particulate matter by allowing fluid to pass through the structure while preventing specific matter from passing therethrough. Other exemplary embodiments of the filter 222 include porous polymers, textiles, or sintered semipermeable polymers. The outflow portion 230 has an output orifice 232 that fluidly connects the outflow chamber 226 to the vacuum pump 80 to directly receive the generated vacuum.

[0186] During the surgical procedure, the container of the thrombus trap 200 is sealed when closed and used. In an exemplary embodiment, the thrombus trap 200 can be disassembled and opened to remove the thrombus from the trap chamber 224 and be inspected by a surgeon or pathologist, and for sterilization when the thrombus trap 200 is reusable.

[0187] It should be noted that when the thrombus 4 is captured in the trap chamber 224, the trap chamber 224 is also filled with blood regardless of whether the vacuum is still being applied. Therefore, even if the entire thrombus trap 200 is transparent for the user to observe the inside, the thrombus 4 cannot be visualized. In order to help visualize the thrombus 4 contained in the trap chamber 224, the thrombus trap 200 is configured to temporarily clear its own fluids, which visually hinder the inspection of the captured thrombus material. Therefore, in an exemplary embodiment, the inflow portion 212 is formed with an intake bleed valve 214 that is fluidly connected to the vacuum channel 3 and the trap chamber 224. The bleed valve 214 is configured to operate in a closed mode and in a bleed mode, in which any flow of air and / or fluid passing through the bleed valve 214 and entering the trap chamber 224 (or the vacuum channel 3) is completely restricted, and in the bleed mode, the bleed valve 214 inhales fluid, especially ambient air. (Alternatively, if desired, the deflate valve 214 can aspirate a clear liquid, such as saline, in the deflate mode.) During the closed mode operation, the outlet of the deflate valve 214 is closed, and the aspirated material flows unimpeded from the input orifice 212 through the thrombus trap 200 and out the output orifice 232 toward the vacuum source, thereby leaving the aspirated thrombus and other solid material in the trap chamber 224. Thus, when a surgeon has captured a thrombus 4 in the trap chamber 224 during a thrombus removal procedure, the surgeon can immediately visualize the thrombus 4 by setting the deflate valve 214 to the deflate mode, due to the relatively large size of the input opening of the deflate valve 214, and due to the reduced resistance to vacuum due to the opening to ambient air, causing the vacuum pump to quickly draw ambient air into the trap chamber 224, thereby expelling all fluid from the trap chamber 224. During the examination, the deflate valve 214 can be configured to block the fluid connection between the trap chamber 224 and the vacuum channel 3. Actuation of the deflate valve 214 may be separate from or mechanically connected to the controller 10, such that when the controller 10 is in an unactuated state where suction is occurring, a deflate switch on the controller may activate the deflate valve 214. The rapid inflow of air into the trap chamber 224 is directed by a decreasing pressure gradient between the external environment and the relatively low pressure present within the volume present between the trap chamber 224 and the vacuum pump 80. Thus, when the deflate valve 214 is open, the air flow displaces liquid from the volume of the thrombus trap 200, causing the volume to be mostly filled with transparent air rather than opaque blood. This temporary transparency allows for easier inspection of the material captured by the filter 222. The surgeon can then see that the thrombus 4 is unobstructed within the trap chamber 224. During this inspection, control of the vent valve 214 (which may be mechanical or a processor-based controller) may cause the vacuum pump 80 to reduce the vacuum or shut down completely, at least until the surgeon is ready to continue the thrombus removal procedure (if necessary).Normal suction is resumed when the purge valve 214 is set back to the closed mode and the trap chamber 224 is reconnected to the vacuum channel 3. Alternatively, the purge valve may be connected to a fluid flush line, such as a saline drip bag.

[0188] Detection of thrombus 4 may be enhanced by providing thrombus trap 200 with optical filters optimized for visual contrast, the transparent trap attachment, built-in magnification or visualization systems, lighting, and / or sensor-based thrombus detection methods.

[0189] In an exemplary configuration, the vacuum booster 100 is disposed upstream of the thrombus trap 200 and is located on a side of the controller 10 opposite to the thrombus trap 200, such as Fig.21 Thus, in order to maintain the efficacy of the thrombus trap 200 as the endpoint for all aspirated thrombi 4, a vacuum booster configuration that may entrap or significantly damage or macerate thrombi is less than ideal. An exemplary embodiment of a gentler vacuum booster 200, not Fig.16 and 17 The piston design couples a portion of the conduit of the vacuum tube 2 having a deformable internal volume to a mechanical actuation mechanism. The mechanism is capable of contracting and expanding the internal cross-section of a certain length of the vacuum channel 3 to increase or decrease the pressure along that length. Another mechanical embodiment of the vacuum booster without pneumatic actuation derives energy for vacuum boosting from energy imparted by actuation of the controller 10 or from a separate energy input. For example, when a user depresses a lever in the controller 10 that blocks flow and temporarily causes a column displacement, the movement of the lever also erects and releases a spring-loaded piston that produces vacuum boosting. Another exemplary embodiment of the vacuum booster is to place a screen between the vacuum chamber 114 of the vacuum booster 100 and the vacuum channel 3 of the suction system. The screen allows fluid communication between the two internal volumes, but blocks particulate matter from entering the piston hole defined by the vacuum chamber 114. Another exemplary embodiment of preventing thrombotic blockage / accidental impregnation changes the connector 140 to be a flexible diaphragm mechanically disposed between the surface of the vacuum piston 122 and the opening into the vacuum channel 3. Fig.16 and 17 The piston configuration of the embodiment of the present invention. For example, a diaphragm can be included in and across the actual opening of the vacuum channel 3. Such a membrane transmits volume displacement while excluding all flow. The membrane can be separate from the vacuum piston 122, fluidically coupled or attached thereto. In each of these configurations, whether the vacuum booster 100 is in an energized state or in a static state, the volume through which the fluid column flows is unimpeded to prevent the thrombus 4 from being trapped or damaged during passage.

[0190] Both vacuum boosters and blood purifying clot traps rely on the timely and controlled application of vacuum or ambient pressure to specific portions of the device, i.e., the deflation valve 214 of the thrombus trap 200 or the plunger 120 of the vacuum booster 100. The self-clearing thrombus removal aspiration catheter described and illustrated herein may be provided with additional features actuated by the same user input as the self-clearing function, e.g., user input at or through the controller 10, but which is used to open or block additional conduits for vacuum or atmospheric pressure air that control device features (e.g., the self-clearing thrombus trap 200 and / or the vacuum booster 100).

[0191] The vacuum channel 3 of the vacuum tube 2 (and any other conduits within the catheter) may be coated with a hydrophobic coating, such as carnauba wax, to reduce head loss during suction.

[0192] Using an appropriate pressure sensor (e.g., a piezoelectric diaphragm sensor, an electromagnetic diaphragm sensor, a strain gauge diaphragm sensor, or a MEMS pressure integrated circuit sensor), the controller 10 can determine when the vacuum channel 3 is blocked by a thrombus and automatically execute the unblocking procedure described herein. In an exemplary embodiment, a computer connected to the sensor can detect pressure drops and insufficient flow associated with thrombus blockage within or at the vacuum channel 3. When a blockage is detected, the sensor triggers a sequence to stop applying vacuum in the vacuum channel 3 and execute a column shifting sequence. With respect to visualization of the thrombus 4 in the device, another exemplary embodiment of the sensor includes an optical sensor that detects the presence of a thrombus in either or both of the distal opening of the vacuum channel 3 and the thrombus trap 200. In the latter configuration, an optical sensor associated with the trap portion 220 detects when a thrombus 4 is present and causes a purge of the fluid by opening the vent valve 214.

[0193] As described herein, the vacuum tube 2 can be made of a variety of materials. Some materials used for the vacuum tube 2 have relatively low compressive strengths, such as latex, silicone, and other synthetic rubbers. Other materials used for the vacuum tube 2 have relatively high compressive strengths, such as Polyurethane and polyvinyl chloride. Because the vacuum tube 2 within the controller 10 will expand when there is positive pressure in the vacuum passage 3 and will contract when there is negative pressure, this flexible property of the material from which the vacuum tube 2 is made may reduce effective column displacement. In order to reduce these effects of pressure (positive and negative pressure) on the vacuum tube 2, the vacuum tube 2 can be reinforced with a braid or coil or other mechanical structure to support the portion of the vacuum tube 2 within the controller 10 from being affected by pressure changes. In the case where the vacuum tube 2 is made of a material with a relatively low compressive strength, the cross-section of the vacuum tube 2 located within the controller 10 is as short as possible to minimize the expansion / contraction effect.

[0194] Fig. 22 Shows Figure 1An alternative embodiment of the controller 10 of , which indirectly operates the vacuum channel 3 via the compression roller 60. Fig. 22 In an exemplary embodiment of the present invention, the extrusion compressor is replaced by a volume change controller 300 that is directly fluidically connected to the vacuum channel 3 of the vacuum tube 3. The volume change controller 300 has a barrel 310, which has an interior 311 and defines an input hole 312 that is fluidically connected to the vacuum channel 3. The barrel 310 also defines a plunger hole 314, a pump hole 316, and a purge hole 318. The plunger 320 is sealably connected to the interior 311 of the barrel 310 and is movable toward and away from the input hole 314. When in Fig. 22 In the position shown, the vacuum applied by the vacuum pump 80 is connected to the distal opening of the vacuum channel 3 for aspiration of material. When the thrombus is blocked at the distal opening, the surgeon presses the plunger 320 inwardly. In the first part of the inward movement, the surface of the plunger 320 seals the pump hole 316 to stop the application of vacuum to the vacuum channel 3. In the second part of the inward movement, the plunger 320 moves all the fluid contained in the interior 311 and the vacuum channel 3 distally to cause the column displacement. Reversal of the plunger reverses the column displacement and reapplies vacuum to the vacuum channel 3.

[0195] The plunger 320 can also be used to control the purge of the thrombus trap 200. The plunger is equipped with a purge conduit 322. When the plunger 320 is placed in the purge position, the plunger 320 closes the vacuum channel 3 from the vacuum pump 80 and connects the pump hole 316 fluid to the purge hole 318 through the purge conduit 322. In this position, the fluid connected to the purge hole (e.g., ambient air) is sucked into the thrombus trap 200 through the purge conduit 322 and the purge hole 318.

[0196] about Fig.24 The system cycle diagram illustrates the operation of the volume change controller 300.

[0197] State 1: Normal suction is taking place. The vacuum channel 3 is not blocked. The volume change controller 300 is in a stationary state with the vacuum pump 80 connected to the vacuum channel 3.

[0198] • Transition A—Occlusion: Thrombus 4 blocks the distal end of vacuum channel 3. Controller 300 actuates (inserts) to block vacuum channel 3 and stops vacuum flow distal to controller 300.

[0199] State 2: Flow through vacuum channel 3 has stopped.

[0200] • Transition B - Unblocked: Controller 300 continues to be inserted to create reverse flow in vacuum channel 3 for metered volume column displacement.

[0201] State 3: Flow reversal stops.

[0202] • Transition C - Return Column Displacement: By reconnecting the vacuum pump 80 to the vacuum channel 3, the controller 300 reverses to return the column and accelerate the thrombus 4 into the catheter tip.

[0203] Return to state 1 and repeat: normal aspiration occurs.

[0204] Figures 25 to 41 An exemplary embodiment of an aspiration thrombectomy system 400 is shown that begins operation with automatic, rapid, and repeated pressure changes. Fig.26 Schematically shown in , it is drawn from the distal orifice of a pair of valves 420, 440 (in this exemplary embodiment, pinch valves 420, 440). One of these valves is a pinch valve 420 for controlling vacuum flow, and is connected between the suction catheter 410 and the suction pump (e.g., vacuum pump 80). Another of these valves is a pinch valve 440 for controlling exhaust flow, and is connected to the supply of exhaust liquid. In an exemplary embodiment, the exhaust liquid can be any one of albumin, d5W water, saline, semi-normal saline, and lactated Ringer's solution. The exhaust liquid can also be any other biocompatible fluid, such as a contrast agent or tissue plasminogen activator (tPa). With this fluid, the catheter 410 can perform different functions. For example, the exhaust liquid is switched to a contrast agent after the clot is considered to have been successfully removed, allowing the surgeon to inject the contrast agent into the blood vessel to confirm that the clot has been removed. This is important because the catheter 410 changes from an aspiration function to a contrast injection function without any noticeable movement within the vasculature. With a standard aspiration catheter with a clot lodged at the distal end, the entire catheter would need to be removed from the patient and reintroduced through the vasculature for visualization if contrast injection at that site is desired. The venting liquid may be at atmospheric pressure or at a pressure above or below atmospheric pressure.

[0205] In one exemplary configuration, the valves 420, 440 are mounted to a base 401. Operably associated with the pinch valves 420, 440 are respective cams, a vacuum cam 430 and an exhaust cam 450. The cams 430, 450 are connected to a camshaft 460. A first axial end 462 of the camshaft 460 is fixedly connected to a shaft bearing 470 in a freely rotatable manner. The shaft bearing 470 has a bearing body 472 mounted to the base 401. A second axial end 464 of the camshaft 460 is connected to a shaft drive assembly 500. The shaft drive assembly 500 includes a motor 510, a transmission or gearbox 520, a coupling 530, and a motor controller assembly 550.

[0206] The transmission 520 has an output shaft 522. To connect the transmission 520 to the camshaft 460, a first coupling end 532 of the coupling 530 is connected to the output shaft 522 and a second coupling end 534 of the coupling 530 is connected to the second shaft end 464. In this manner, rotation of the motor 510 corresponds to rotation of the camshaft 460 (at the same or different speeds based on the gears of the transmission 520) and corresponding rotation of the vacuum cam 430 and the exhaust cam 450.

[0207] The control of the motor 510 originates from a motor controller assembly 550, which includes a controller 560, a position encoder 570, and a position reset assembly 580. In an exemplary embodiment, the controller 560 is a microcontroller having a user interface (UI) including user inputs, the user inputs including, for example, control buttons to operate the aspiration thrombectomy system 400 in various states, examples of which are described in further detail below. The controller 560 having the UI is Fig.30 4 is shown diagrammatically in FIG. To isolate the components from the fluid, in this exemplary embodiment, the motor 510, transmission 520, coupling 530 and motor controller assemblies 550, 560, 570, 580 are contained in a motor assembly housing 552. The connection between the motor assembly housing 552 and the camshaft 460 is fluid-tightly sealed with a shaft seal 554. Similarly, the cams 430, 450, the camshaft 460 and the shaft bearing 470 are covered by a cam housing 466. The controller 560 is Fig.30 552, but may also be integrated into or attached to the motor assembly housing 552. In a wireless configuration, the controller 560 may be an application on a computer or smartphone, for example, with all UIs accessible via a touch screen.

[0208] The vacuum cam 430 and the exhaust cam 450 are rotationally fixed to the camshaft 460. These cams 430, 450 have various cam profiles to operate the valves 420, 440. It is desirable to know the precise rotational position of the cams 430, 450 and therefore the camshaft 460 so that the controller 560 can set the valves 420, 440 to any desired state. Because the motor 510 rotates freely and can end its rotation at any rotational position, it is desirable to know the precise rotational position of the camshaft 560 at all given times. Therefore, the motor controller assembly 550 includes a position encoder 570 associated with the motor 510. Through this association, information about the precise rotational state of the camshaft 460 and therefore the cams 430, 450 is provided to the controller. The position encoder 570 includes an encoder disk 572 and an encoder circuit 574. The encoder 570 is capable of detecting and reporting the current relative rotational position of the motor 510 to the controller 560 at any point in time.

[0209] Those skilled in the art will appreciate that the motor 510 and / or position encoder 570 may drift during use. To account for and correct for any drift, the motor controller assembly 550 includes a position reset assembly 580. The position reset assembly 580 designates a single rotational position of the camshaft 460 as a reset point, and each time that position crosses the zero line, the position encoder resets the position of the motor 510 to zero, which in turn allows the system to know the absolute position of the camshaft 460. In an exemplary embodiment, the position reset assembly 580 includes a photodiode 582 and a flag or interrupter 584. As shown in FIG. Fig.30 As shown, the flag 584 is fixed to the coupling 530. The photodiode 582 is placed in the path of the flag 584 so that the flag 584 interrupts the photodiode 582 once every rotation of the camshaft 460. This exemplary embodiment allows any skipped steps of the encoder 570 to be corrected immediately.

[0210] Exemplary embodiments of the pinch valves 420, 440 use an exhaust pinch valve 440 to refer to Figures 31 to 33 444. The cavities of the tubes 426 and 446 are connected to the distal ends of the cavities 424 and 444. The cavities of the tubes 426 and 446 are connected to the distal ends of the cavities 424 and 444. The cavities of the tubes 426 and 446 are connected to the distal ends of the cavities 424 and 444. Fig.31 and 32 The left side) is fluidly connected to the proximal end of the chamber 424, 444 ( Fig.31 and 32 The middle portion of the valve body 422, 442 defines a follower connection in which the cam follower 421 is movably secured. A first end of the cam follower 421 is biased against an outer surface of the cam 430, 450 by a biasing device not shown, or is simply captured in place. An opposite second end of the cam follower 421 abuts against a middle portion of the tube 426, 446. Thus, when moved toward the tube 426, 446 by the cam 430, 450, as shown in FIG. Fig.32 As shown, the cam follower 421 fluidly seals the cavity of the tubes 426, 446, and when the cam follower 421 is allowed to return from the tubes 426, 446, as shown in FIG. Fig.31 As shown, the cam follower 421 opens the cavity of the tubes 426, 446. In this exemplary embodiment, the cam follower 421 is pill-shaped, but it can be formed into any shape that provides the function of closing the tubes 426, 446.

[0211] Both the vacuum line 402 and the vent line 404 are connected to the proximal end of the suction catheter 410 through selectively open valves 420, 440. In operation, the vacuum cam 430 and the exhaust cam 450 push downward on their respective cam followers 421, which squeeze downward on short sections of tubes 426, 446 that are fluidly connected to the vacuum line 402 and the exhaust line 404, respectively. When the vacuum line 402 is open and the vent line 404 is closed, vacuum is drawn into the suction catheter 410. When the distal end of the catheter 410 is blocked by a clot, the closure increases the vacuum level within the catheter 410 to full (the maximum current vacuum produced by the vacuum pump). The closure creates a pressure difference (delta in pressure) between the lumen of the catheter 410 and the external environment of the catheter 410, which radially and longitudinally squeezes the body of the catheter 410 downward (e.g., the diameter and length gradually decrease). This change also draws a small volume of liquid from the lumen of the catheter 410. In an exemplary embodiment, the volume is about 0.2 ml. The net effect is to create a spring-like force within the conduit 410 that wants to expand the conduit 410 back to its stable state, but this cannot happen when the vacuum line 402 is closed. Thus, the vacuum is stored as potential energy until the vent line 404 is opened (e.g., in Fig.26 As can be seen in the figure, the vacuum line 402 and the ventilation line 404 are connected together at the distal side of the valves 420 and 440). When the ventilation line 404 is opened, there is an influx of fluid due to the pressure delta. This influx of fluid balances the radial force of the catheter 410 and draws in fluid to generate a distally directed momentum in the liquid column in the catheter 410 at the distal side of the valves 420 and 440. The momentum causes a small amount of liquid to flow through the distal portion of the catheter 410 and causes a small distal movement of the clot stuck in the distal opening at the end of the catheter 410. Once the clot is no longer stuck at the distal opening, it can move toward the proximal side of the catheter 410 and through the catheter 410 as a vacuum is subsequently applied to the catheter 410. Repeated selective actuation of vacuum and exhaust causes the clot to soak at the distal opening, thereby re-forming it into a state in which the clot can be completely sucked into the lumen of the catheter 410 and out of the blood vessel. In this exemplary embodiment, forward fluid flow is intentional, in contrast to other exemplary embodiments herein where there is substantially no forward flow.

[0212] The system 400 can be operated in various modes to remove clots from a blood vessel. The rotation of the cam is measured in degrees, with a full rotation being a movement of 360°. In a first exemplary embodiment, the vacuum cam 430 is configured to establish a vacuum in the catheter 410 by a rotation of approximately 220°. The exhaust cam 450 is configured to have an exhaust function by a rotation of approximately 80°. The configuration of the cams 430, 450 simultaneously stops exhaust and vacuum between respective applications of vacuum and exhaust, for example, a rotation of 30°. Thus, this configuration results in operating states according to Table 1 below.

[0213] Table 1 state vacuum exhaust Cam Angle close 0 0 0 to +30 vacuum 1 0 +30 to +250 close 0 0 +250 to +280 exhaust 0 1 +280 to 0

[0214] As soon as the vent is opened, there is an influx of fluid to balance the vacuum pressure, then the vent line 404 is closed and the vacuum line 402 is opened, causing a sudden and rapid drop in pressure, which serves to forcefully pull the clot into the catheter. Therefore, before restoring the vacuum, it is advisable to close both the vacuum line and the vent line.

[0215] In another exemplary embodiment, the vacuum cam 430 is configured to establish a vacuum in the conduit 410 by a rotation of approximately 220°. The exhaust cam 450 is configured to open the exhaust by a rotation of approximately 80°. Thus, in an ideal second exemplary configuration, a pause is created between the vacuum aspiration in the conduit and the exhaust of the conduit, and another pause is created between the exhaust of the conduit and the restoration of the vacuum in the conduit. In this exemplary configuration, the pause may be by a rotation of approximately 30°. In order to create a purge state in which vacuum and exhaust occur simultaneously, the exhaust cam 450 has a small inward depression at the location of the exhaust cam 450 that occurs during a prolonged vacuum opening phase (e.g., between +30° and +250°). The degree of venting is configured to not provide a significant change in pressure or change in vacuum energy, but rather is configured to produce a single rotational position of the cams 430, 450 at which the motor control assembly 550 can stop the rotation of the camshaft 460 in that direction where both the vacuum line 402 and the vent line 404 are connected to the conduit 410, which allows the user to purge out any air that may be present in the system (e.g., in the vacuum line 402, the vent line 404, and / or the conduit 410). The degree of depression can be such that it only partially opens the vent to reduce the amount of vent liquid drawn in during this purge state. This purge can be a known position of cam rotation and is placed in that position to ensure that all lines in the system 400 are purged of air. Such a configuration results in an operating state according to Table 2 below.

[0216] Table 2 state vacuum exhaust Cam Angle close 0 0 0 to +30 vacuum 1 0 +30 to +120 Purge 1 1 +120 to +140 vacuum 1 0 +140 to +250 close 0 0 +250 to +280 exhaust 0 1 +280 to 0

[0217] A third alternative configuration for operating system 400 may include full-time vacuum with pulsed exhaust, including operating conditions according to Table 3 below.

[0218] Table 3 state vacuum exhaust Cam Angle vacuum 1 0 0 to +120 Purge 1 1 +120 to +150 vacuum 1 0 +150 to 0

[0219] A configuration opposite to that of Table 3 may include full-time exhaust with vacuum overlap.

[0220] A fourth alternative configuration for operating system 400 may include vacuum during exhaust, which configuration includes operating conditions according to Table 4 below.

[0221] Table 4 state vacuum exhaust Cam Angle Purge 1 1 0 to +30 vacuum 1 0 +30 to +250 close 0 0 +250 to +280 exhaust 0 1 +280 to 0

[0222] A configuration opposite to that of Table 3 may include full-time exhaust with vacuum overlap.

[0223] A fifth alternative configuration for operating system 400 may include exhaust during vacuum, including operating conditions according to Table 5 below.

[0224] Table 5 state vacuum exhaust Cam Angle close 0 0 0 to +30 vacuum 1 0 +30 to +250 Purification 1 1 +250 to +280 exhaust 0 1 +280 to 0

[0225] In further alternative configurations, there may be an overlap of exhaust and vacuum changes that would remove one or more of the shutdown states in any of the above state tables.

[0226] The cam-driven valves 420, 440 allow the position encoder-driven motor to create positions for vacuum, exhaust, closing and purging. The motor controller assembly 550 allows the cams 420, 440 to be controlled by any frequency, for example, they can be set to move through various states at any given speed, such as 4Hz. The frequency at which the motor runs may be more suitable for running at a lower frequency, such as 0.5Hz, 1Hz or 2Hz. Alternatively, running at a higher frequency such as 8Hz, 12Hz or 16Hz may be more effective. The motor control assembly 550 can also dynamically change the rotation rate of the camshaft 460 to sweep the rotation frequency. In an exemplary embodiment, the step size of the speed is in the range of 1Hz to about 4Hz, the change in increment is between about 0.25 seconds to about 5 seconds, and the rotation range is between about 2Hz to about 12Hz. An example of step size, increment and range is, in the following process 2Hz / 4 / 6 / 8 / 10 / 12 / 10 / 8 / 6 / 4 / 2 / …, 2Hz, 1 second increment. Another example is 4 Hz, 0.5 second increments in the following progression 4 Hz / 8 / 12 / 8 / 4 / ... In an exemplary embodiment, the system uses higher frequencies in the 8 Hz to 12 Hz range, and it has been observed that there is less movement of the proximal end of a clot stuck at the distal end of the catheter 410. Alternatively, additional increments may be used to sweep the frequency through complex patterns, such as sinusoidal, sawtooth, stepped, and pulse variations.

[0227] In an exemplary alternative to pinch valves 420, 440, these valves may be solenoid-driven pinch valves or voice coil actuators. In another exemplary alternative, a rotary needle valve may be used, such as Figures 42 to 46 For example, Figures 42 to 44 The first valve state may be a vacuum open / exhaust closed state, as shown in Fig.45 and 46 The second valve state may be a vacuum closed / vent open state.

[0228] It has been determined that the most rapid onset of vacuum and venting is desirable. To achieve this rapid onset, the cams 430, 450 initiate vacuum and venting, respectively, with a cliff 452 on the shape of the cams 430, 450. The sudden creation of vacuum rapidly reduces the pressure within the catheter 410, which will attract the clot actively against the distal end of the catheter 410. As described above, venting creates distal momentum, loosening the clot, and repetition of vacuum and venting results in mechanical maceration of the clot at the distal opening until the clot is completely entered into the lumen of the catheter 410 and removed from the vasculature. Therefore, the present system 400 can be described as a Rapid Onset Aspiration Repeater or ROAR.

[0229] The control performed by the motor controller assembly 550 has a user-actuated button selection. In an exemplary embodiment, one button turns both vacuum and exhaust off, i.e., turns off operation. One button causes vacuum to occur in a continuous manner, i.e., manual control. One button causes exhaust to occur in a continuous manner, i.e., manual control. One button causes the camshaft 460 to rotate the cams 430, 450 to a position where the vacuum line 402 and the ventilation line 404 can be purged, i.e., the purging function. One button causes the system to repeatedly run or pulse according to a desired set of states (e.g., according to any one of Tables 1 to 5) and to any number of groups of steps, increments, and ranges. In this way, if the surgeon wishes to use the system 400 as a simple thrombus removal device, the surgeon can use only the vacuum button. In this case, the encoder 570 helps rotate the camshaft 460 to a position where the vacuum is turned on. The vacuum pump operates under a fully turned vacuum until the surgeon releases the button. For example, if the surgeon wants to purge or inject contrast agent, the surgeon can use the exhaust button to assist the encoder 570 in rotating the camshaft 460 to a position where the exhaust port is open. Likewise, the close button rotates the camshaft 460 to a position where the cams 430, 450 close both the vacuum line 402 and the vent line 404. The purge button rotates the camshaft 460 to a position where the cams 430, 450 allow both vacuum and venting.

[0230] In an exemplary embodiment of the operating or ROAR mode, the rotation of the camshaft 460 is between about 0.5 Hz and about 25 Hz, further, between about 6 Hz and about 16 Hz, and more particularly between about 8 Hz and about 12 Hz. In this exemplary ROAR cycle, the camshaft 460 rotates between about 10 seconds and about 30 seconds, and during this time, the motor controller assembly 550 sweeps the motor 410 through a frequency between about 2 Hz and about 12 Hz.

[0231] As described above, the elastic tubes 426, 446 are connected to the distal and proximal locations of the valve lumens 424, 444. The compliance of the system 400 distal to the vacuum valve (as described above, including the reduction in diameter and / or length of the catheter 410 and the compliance of the tubes 426, 446) determines how much fluid is withdrawn when the system 400 is under full vacuum when vacuum is applied to the catheter 410 and a clot is stuck at the distal end, and conversely, how much fluid is flushed back into the system 400 when that condition is released. In other words, as the compliance of the distal end of the valves 420, 440 increases, the momentum imparted to the stuck clot by the fluid column increases. It is desirable that a minimum amount of momentum be transferred from the fluid column to the stuck clot to sufficiently loosen the clot so that the next vacuum cycle will immerse the clot in the distal end of the catheter 410 and allow it to enter the lumen of the catheter 410 and be removed from the blood vessel. In order to minimize this compliance (which is fixed for a given catheter 410), the tubes 426, 446 are made as short as possible to still allow the cam followers to perform valve operation. Compliance as used herein refers to the mechanical compliance of the catheter 410 and tubes 426, 446; it does not refer to any air that may be in the system 400, which is purged prior to use as provided herein. This desire to reduce compliance is one reason why the valve system is connected directly to the proximal end of the catheter 410. This tight connection minimizes overall compliance. In an exemplary embodiment, the valve system may be located remote from the catheter 410, and in this case, it is desirable to use a substantially non-compliant tube. Such a configuration may have lower performance due to excessive compliance.

[0232] To determine the status of the clot at the distal end of the catheter 410, the system 400 is placed in ROAR mode. Without the sensors associated with the system 400, the surgeon cannot distinguish between situations where the clot is plugged during ROAR. The surgeon must turn off ROAR and observe whether the catheter is plugged (nothing is being drawn into the catheter 410) or unplugged (blood is being drawn into the catheter 410). With different situations based on flow and pulsation stopping the pulse until it is unplugged, it is difficult to know when the clot is plugged.

[0233] The exhaust line 404 is connected to an exhaust liquid reservoir (not shown) which may contain, for example, any of albumin, d5 water, saline, semi-normal saline, and lactated Ringer's solution. As described above, when the system 400 is vented using liquid, all air may be purged out of the system 400. In addition, knowing that a given amount of exhaust liquid is used at various stages of thrombus removal can allow the user to correlate the removal of the clot into the catheter after the clot is stuck at the distal end with the exhaust liquid usage rate. In other words, the amount of exhaust liquid when the clot is blocked is different from the amount of exhaust liquid when the clot is not blocked. Therefore, the user or sensor can view or measure the use of exhaust liquid to determine the shutdown system. If the catheter 410 is aspirated without obstruction (unplugged), a large amount of blood will flow out of the system 400. If the catheter 410 is aspirated when plugged, no blood will appear at the vacuum outlet. During the ROAR operation and the catheter 410 is not plugged, the user / sensor will detect some blood at the vacuum outlet. Finally, during a ROAR operation, when the catheter 410 is plugged, the vacuum outlet will receive some liquid, which is a combination of blood and exhaust liquid, and in this state, the flow rate of the exhaust liquid can indicate whether the catheter is plugged or unplugged.

[0234] If the surgeon observes free flow during the vacuum and sees a captured clot (e.g., in the thrombus trap 200), the surgeon is able to perform a contrast injection using the catheter 410 to confirm revascularization without moving or removing the aspiration catheter 410. This is in stark contrast to current state-of-the-art aspiration catheters, in which the catheter removes clots by keeping the clot stuck at the end, and the surgeon retracts the entire catheter to drag out the blocked clot. By drawing a larger amount of clot into the catheter, a smaller diameter catheter has the enhanced ability to completely ingest or ensure a better grasp of the clot, which is a significant advantage. Many clots are deep within the anatomy, making it difficult to insert a large catheter into the clot site. If a smaller diameter catheter can improve effectiveness through ROAR, more clots can be approached and retrieved.

[0235] Note that one ideal goal achieved using the system 400 is to completely ingest the clot and bring it back to a standard canister (in a typical thrombus removal tip reservoir) or to the thrombus trap 200. When using a standard aspiration canister and thrombus trap 200, the system 400 can use an exhaust liquid instead of air to flush the thrombus trap 200 through the inlet purge valve 214. This maintains the vacuum pressure in the aspiration canister.

[0236] Turning now to the embodiment that produces maceration but no forward flow, Fig.47An exemplary embodiment of an aspiration thrombectomy system 600 operating in ROAR mode is illustrated. The system 600 includes a vacuum source 610 fluidly connected to an input port of a controllable vacuum valve 620. (For clarity, Fig.47 Components of the vacuum source 610, such as a collection canister, are not shown, but are described in detail below. ) The vacuum valve 620 is fluidly connected to the vacuum input port 632 of the manifold 630. The connection can be direct or through a conduit, such as a silicone tube. An exhaust fluid source or reservoir 640 containing an exhaust liquid 642 is fluidly connected to a controllable exhaust valve 650. For example, the exhaust liquid 642 can be any of albumin, d5 water, saline, semi-saline, and lactated Ringer's solution. As used herein, "controllable" means that the device is able to select between various states, including analog and / or digital switching. An exemplary embodiment is to digitally switch between an open position and a closed position using a single command (e.g., a change in bit position 1 / 0). During use, the entire working channel of the aspiration thrombectomy system 600 should be free of air or other bubbles.

[0237] The exhaust fluid source 640 has a sufficient amount of exhaust liquid in the reservoir that does not end up during a given surgical procedure, which prevents any possibility of air entering the system. If the exhaust fluid source 640 is flexible, such as with fluid supplied by a parenteral fluid holding bag or an IV therapy bag, the gas-free container will collapse as the exhaust liquid 642 is used. If the exhaust fluid source 640 is inflexible and has an air pocket or air bag, such as in a replaceable / removable and sterilizable container, the conduit that transfers the exhaust liquid 642 from the exhaust fluid source 640 to the exhaust valve 650 is at a level within the reservoir that keeps the input port of the conduit submerged in the exhaust liquid 642 throughout the given procedure.

[0238] The ROAR catheter 660 defines a working lumen 662 having a distal end 664 fluidly connected to a proximal manifold connector assembly 670 at the proximal end of the ROAR catheter 660, which assembly 670 will be described in more detail below. The ROAR catheter 660 is configured to operate in relatively small blood vessels. Therefore, in an exemplary embodiment, the inner diameter of the lumen is between about 0.038" and about 0.106", and in particular, the inner diameter is between about 0.068" and about 0.088". The proximal manifold connector assembly 670 fluidly connects the lumen 662 to the interior of the manifold 630, and thus, the manifold 630 fluidly connects the lumen 662 to the vacuum source 610 through the vacuum valve 620, and fluidly connects the lumen 662 to the exhaust fluid source 640 through the exhaust valve 650. When used within a blood vessel, the lumen 662 is filled with a liquid column having a proximal portion and a distal portion. Depending on the circumstances surrounding the use of catheter 660, the proximal and distal portions of the liquid column can be given amounts (e.g., less than 20 microliters or less than 5 microliters), can be given lengths (e.g., several millimeters or several centimeters), or can be instances of columns approximated using statistical flow analysis. For example, when discussing whether the distal portion of the liquid column leaves the distal end of cavity 662, the distal portion is an instance of the measurable distance at the distal end of the liquid column, equal to the liquid present at the plane of the distal outlet of the cavity. In the field of statistical analysis in this example, the distal portion is the last distal finite element in the finite element analysis (FEA) of the liquid column. Here, system 600 is used to substantially prevent forward flow. The term "forward flow" is used herein to define the amount of liquid in cavity 662 that leaves distal end 664 in the distal direction. Forward flow is defined as greater than 6 microliters of fluid (ID is 0.071", catheter length is approximately 1 mm = 5.7 μL). Lesser forward flow is also included in this definition. For example, the amount of forward flow can be limited to no more than 2 microliters, or in particularly beneficial embodiments, the forward flow can be approximately 0 microliters. In each case, no forward flow means that essentially no fluid leaves the distal end 664 in the distal direction.

[0239] Operation of the aspiration thrombectomy system 600 occurs via a controller 700, which may be an analog controller or a digital controller. An example of an analog controller is shown in Figures 25 to 46. An example of a digital controller will be described in more detail below. One exemplary construction of a digital controller is a microcontroller manufactured by Microchip Technology, Inc. The controller 700 is operably connected to each of the vacuum valve 620 and the exhaust valve 650 (as well as to the vacuum motor described below). The controller 700 selectively opens and closes the vacuum valve 620 and the exhaust valve 650 so that when the vacuum valve 620 is open, the vacuum source 610 is fluidly connected to the liquid column in the chamber 662, and when the exhaust valve 650 is open, the exhaust liquid 642 is fluidly connected to the liquid column in the chamber 662. The timing of these valves is important so that the controller 700 can change the vacuum level at the distal end 664 and prevent the distal portion of the liquid column in the chamber 662 from leaving the distal end 664 - essentially without forward flow. When operating the valves 620, 650, there are two important actions that contribute to forward flow: compliance of the catheter system and the water hammer effect. Each will be discussed in turn. Exemplary constructions of vacuum and exhaust valves are described in Figures 25 to 36 and Figures 42 to 46 The configurations of these valves include spool valves, pinch valves, rotary valves, and rotary valves with a pintel design.

[0240] To explain the timing of the valve to eliminate forward flow, first refer to Fig.47 It should be noted that the ROAR catheter 660 is a flexible body, and therefore, it is compliant in both the radial and longitudinal directions. Fig.47As shown in FIG. 6A , a vacuum is applied to the cavity 662. Thus, the compliance of the catheter 660 results in a reduction in the diameter of the catheter and a reduction in the length of the catheter. When the catheter 660 is plugged, no flow occurs in the cavity. By making the pressure within the cavity 662 lower than atmospheric pressure, the catheter 660 contracts and decreases (shortening radially and longitudinally). This contraction is like a spring pressing down on the cavity of the catheter, in other words, it is a storage of potential energy. If the vacuum source is subsequently cut off (e.g., the vacuum valve 620 is closed) and the exhaust valve 650 is opened to the exhaust fluid source 640, the catheter 660 stretches and acts as a piston pulling toward the exhaust liquid 642. In addition, the exhaust liquid 642 is at a higher pressure (e.g., atmospheric pressure or slightly elevated by having a higher physical position than the patient) than the fluid in the cavity 662. Therefore, a certain amount of exhaust liquid 642 enters the manifold 630 through the exhaust valve 640 and then enters the cavity 662 through the proximal manifold connector assembly 670. When the exhaust liquid 642 flows in and the catheter 660 expands to its normal or free stable state, a momentum directed toward the distal end is generated in the fluid column, which is referred to as a pressure pulse or pressure wave. In other words, a "pressure pulse" or "pressure wave" is a momentum within the fluid column that can be used to move the distal portion of the fluid column in the catheter lumen distally out of the distal end of the catheter. The term relates to a given cycle of the vacuum valve 620 and the exhaust valve 650, and is not limited to a single pressure transmission with the cycle. Therefore, the pressure pulse can include multiple pressure differences for a given cycle with the vacuum valve 620 and the exhaust valve 650. Therefore, by adjusting the timing of the vacuum valve and the exhaust valve to match the compliance and length of a specific catheter system (which may include a catheter, and also include a manifold and valves and other cavities consistent with the catheter), the ROAR effect of the catheter can be achieved. Specifically, one method of achieving the ROAR effect and preventing the distal portion from flowing forward from the distal end during each cycle is by adjusting the timing of the exhaust valve 650.

[0241] The suction thrombus removal system of the prior art periodically opens and closes the vacuum valve. While the vacuum valve is open and vacuum is applied to the fluid column, the fluid rushes into the distal end of the catheter. When the vacuum valve is closed, the liquid surging through the cavity proximally stops by hitting the closed vacuum valve. This causes pressure to be generated at the vacuum valve and generates a rebound wave, which carries momentum toward the distal end and ejects a certain amount of fluid distally from the distal end of the catheter. This effect is called the water hammer effect. The prior art repeatedly opens and closes the vacuum valve. Therefore, a certain amount of liquid is periodically ejected from the distal opening of these devices. This forward flow phenomenon is undesirable in the thrombus removal area because when the liquid is allowed to eject from the distal end and the doctor brings the distal end close to the thrombus, the liquid may or will cause the thrombus to move further distally, or it can rupture the thrombus, causing the arterial blood pressure to push the ruptured fragments further downstream, for example, into smaller cerebral arterial vessels. Therefore, in the thrombus suction removal system, it is best to completely prevent any distally directed pressure pulses from reaching the distal end of the suction catheter. As described herein, the system 600 has a response to the water hammer effect that is tuned to achieve maximum water hammer effect without inducing forward flow, which achieves the most effective engagement and disruption of the thrombus.

[0242] The proximal pressure measuring device 690 and the distal pressure measuring device 692 are as shown in FIG. Fig.47 In this exemplary embodiment, the proximal pressure measuring device 690 is adjacent to or within the proximal manifold connector assembly 670 and / or within the proximal portion of the fluid column, and the distal pressure measuring device 692 is adjacent to or within the distal end 664 or within the distal portion of the fluid column. Exemplary embodiments of the measuring devices 690, 692 include pressure sensors manufactured by TransducersDirect.com.

[0243] Measurements in the fluid column of the catheter 660 at or near the manifold 630 and near the distal end 664 reveal a time delay in the travel of the pressure pulse - the pressure first increases at the manifold 630, and then the pressure increases at the distal end 664. By knowing the time delay and the distance between the sensors, the speed of the wave can be calculated. By knowing the distance from the most distal sensor to the end of the catheter 660, the time required for the wave to travel to the distal end can be calculated. The controller can use this information to appropriately time the valve to stop the pressure pulse. If the pressure pulse is allowed to travel all the way to the distal end 664, the distal portion of the fluid column in the cavity 662 will leave the distal end 664, e.g., flow forward. If during this period, the distal end 664 is blocked by a thrombus 4, the pressure pulse can or will eject the thrombus 4 distally. Alternatively, if the distal end 664 is approaching a thrombus 4, any pressure pulse leaving the distal end 664 can or will cause the thrombus 4 to move further distally. Movement of the thrombus 4 in the distal direction before or after it is captured and blocked at the distal end 664 of the catheter 660 should be avoided. Therefore, the pressure pulse needs to be reversed or stopped before the pressure pulse reaches a point where the thrombus 4 can move further downstream or away from the distal end 664 in the distal direction. This reversal is referred to herein as "quelling" the pressure pulse.

[0244] Operation of the aspiration thrombectomy system 600 with the ROAR effect does not produce the same results as prior art catheters. When operating with the distal end 664 open, the vacuum valve 620 and the exhaust valve 650 are periodically opened and closed. While the vacuum valve 620 is open and vacuum is applied to the fluid column, fluid rushes into the distal end 664 of the catheter 660 and the tank of the vacuum source 610. When the vacuum valve 620 is closed, the sudden cessation of flow creates a pressure wave caused by the water hammer effect of the closure of the vacuum valve 620 as described above. The controller 700 is timed to control the vacuum valve 620 and the exhaust valve 650 to produce the ROAR effect even when the distal end 664 is open to the vasculature, so that any distally directed pressure pulses in the aspiration thrombectomy system 600 are quenched, resulting in essentially no forward flow during the thrombus removal process. Through experiments, the net flow of liquid at the distal end 664 remains positive in the proximal direction - in other words, when operating in the ROAR effect in either the blocked or unblocked state, the liquid either moves through the distal end 664 toward the vacuum source (when unblocked) or does not flow at all (when blocked). In both cases, substantially no liquid leaves the distal tip 610.

[0245] To achieve the ROAR effect, the change in the vacuum level at the distal end is at least about 15 inHg, further at least about 20 inHg, and in particular at least about 25 inHg. The change time of the vacuum level at the distal end from low to high or from high to low is no more than about 50 ms, further no more than about 30 ms, and in particular no more than about 20 ms. This change can be referred to as the maximum pressure difference. Various combinations of these variables include a change in the vacuum level of about 15 inHg and a change time of no more than 50 ms, or a change in the vacuum level of about 20 inHg and a change time of no more than 30 ms, or a change in the vacuum level of about 25 inHg and a change time of no more than 20 ms.

[0246] In accordance with Fig.48 In the exemplary embodiment of the graph of FIG. 6 , the ROAR catheter 660 is operated to calm all pressure pulses. The state of the vacuum valve 620 is shown in the waveform at the top of the graph, and the state of the exhaust valve 650 is shown in the waveform at the bottom of the graph. In this exemplary embodiment, the repeating cycle begins at time 0 as the valves begin to open. At time 1, the vacuum valve 620 is fully open and the exhaust valve 650 is closed. The vacuum continues until time 2, when the vacuum valve 620 begins to close. The closing of the vacuum valve 620 is not instantaneous, and therefore, the vacuum valve waveform decreases at an acute angle and is fully closed at time 3. After the vacuum valve 620 is closed, at time 4, the exhaust valve 650 begins to open. This closing of the vacuum valve 620 initiates the water hammer, and the closing of the vacuum valve 620 and the subsequent opening of the exhaust valve 650 cause the exhaust liquid 642 to enter the manifold 630 (and possibly into the proximal end of the cavity 662). The potential energy stored in the compliant conduit 660 is also allowed to release due to the change in pressure from the negative pressure created by the vacuum source 610 to the relatively greater pressure (e.g., arterial) present in the exhaust fluid source 640. This combination of events initiates a pressure pulse at time 2 that travels distally through lumen 662 toward the distal end. If there are no further changes to valves 620, 650, the liquid in the column will be ejected from the distal end 664, i.e., flow forward. However, if Fig.48 As shown, after a relatively short exhaust opening time compared to the vacuum opening time, the exhaust valve 650 closes (at time 7), and shortly thereafter, the vacuum valve 620 opens. This means that while the pressure wave travels distally along the length of the lumen 662 of the catheter 660, when the exhaust valve 650 closes to shut off the exhaust liquid 642 and the vacuum valve 620 opens to reopen the vacuum (time 0 of the repeating waveform), the switching of these valves 620, 650 stops the exhaust liquid 642 from entering the manifold 630 and moves the fluid in the manifold 630 and lumen 662 proximally into the collection tank 612 of the vacuum source 610 (see, e.g., Fig.55). Thus, a reverse momentum is generated within the fluid column. This reverse momentum is large enough to prevent the pressure pulse from reaching the point where the distal portion of the fluid in cavity 662 leaves the distal end 664, thereby calming the pressure pulse and preventing forward flow. Thus, the ROAR effect can maintain the pressure level at the distal end at a level less than or equal to the physiological pressure. Fig.48 The region 690 of the two waveforms shown includes the time when the pressure pulse has subsided. The waveform repeats in a periodic manner to continue the distal-then-proximal momentum pulse without ever allowing the distal portion to leave the distal end 664 of the catheter 660. The rapid change in pressure at the end of the catheter from near full vacuum to near zero vacuum is the ROAR effect. Under the ROAR effect, the pressure at the distal end 664 can rise to just less than the arterial pressure and then begin to reverse the rise due to the re-establishment of the vacuum. This enables the aspiration thrombectomy system 600 to approach the thrombus 4 without distal movement of the thrombus 4, and retain the blocked thrombus 4 at the distal end 664 without any distal movement of the thrombus 4 due to pressure changes within the fluid column.

[0247] Fig.49 Another exemplary embodiment of using a conduit 660 to produce a ROAR effect using a vacuum valve 620 and an exhaust valve 650 is shown in the waveforms of , which are repeated at an exemplary rate between about 1 Hz to about 250 Hz, further between about 2 Hz to about 20 Hz, further between about 4 Hz to about 12 Hz, and particularly between about 6 Hz to about 8 Hz. At time 1, the vacuum valve 620 is in the open / on position and the exhaust valve 650 is in the closed / off position. At about time 2, the vacuum valve 620 begins to transition to the closed / off position. At about time 3, the vacuum valve 620 is closed / off. At time 4, the exhaust valve 650 begins to open, and at about time 5, the exhaust valve 650 is fully open. The exhaust valve 650 remains open while the vacuum valve 620 is closed until time 6 when the exhaust valve 650 begins to close. The exhaust valve 650 is closed at about time 7. The vacuum valve 620 begins to open at time 8 and is partially open at about time 9. When near the bottom range in the graph, the vacuum valve 620 is fully open. This process is repeated periodically, in this example at 10 Hz.

[0248] In what is referred to herein as static suction, the distal end 664 of the catheter 660 is pushed toward the thrombus 4 while suction is applied to the catheter 660. The lower pressure in the catheter 660 creates a force on the clot 4 that is equal to the pressure difference on both sides of the clot 4 multiplied by the area of ​​the inner diameter of the catheter 660. It is this force that "sticks" the clot 4 to the distal end 664 of the catheter 660 in an attempt to retrieve the clot 4 completely.

[0249] In the ROAR cycle, suction is applied to the blood clot by rapidly opening the valve, causing the vacuum pressure to rise rapidly. The suction source is then turned off and the exhaust liquid source is rapidly turned on. This eliminates the vacuum present in the conduit 660, again rapidly changing the pressure applied to the clot. The exhaust valve 650 is then rapidly closed and the vacuum valve 620 is rapidly opened. This cycle is repeated multiple times per second. For example, the repetition period is between about 2 Hz and about 16 Hz, in particular between about 8 Hz and about 12 Hz. When the vacuum valve 620 is opened, the rapid drop in pressure on both sides of the clot 4 causes the clot 4 to accelerate into the cavity 662 of the conduit 660. The release of the vacuum pressure when the exhaust valve 650 is opened causes the clot 4 to rebound from the conduit 660. When the vacuum is applied again, the clot 4 is accelerated toward the conduit 660 again. These accelerations and rebounds cause the distributed mass of the clot 4 to oscillate. The large internal acceleration of the distributed mass generated by the oscillations generates sufficiently high internal forces in the clot 4 that are high enough to exceed the tensile strength of the clot 4 and cause it to fail. Fragments of the clot 4 are then drawn all the way through the catheter 660 and into the vacuum collection canister 612. In order to maximize the force in the clot, the pressure differential across the clot and the rate at which that pressure differential is applied are maximized. The higher the rate at which force is applied to the clot, the higher the internal acceleration of the distributed mass of the clot, and therefore the higher the internal forces within the clot, and therefore the higher the likelihood of the clot tearing apart. The time for the pressure change in both the up and down directions is about 20ms. For example, at 8Hz, each cycle is 125ms, and at 12Hz, each cycle is 83ms. The higher the frequency of the cycles, the greater the number of these shocks that are created by the interaction of the catheter with the clot. Therefore, it is better to use a higher frequency, but only to the point where there is not enough time to create a sufficiently effective pressure increment within each cycle.

[0250] During operation of the catheter 660 with the ROAR effect, the proximal pressure measurement device 690 and the distal pressure measurement device 692 may be used to make measurements of pressure pulses. Fig.50 The graph shows the Fig.49 The pressure sensed by these devices 690, 692 during the exemplary 10 Hz pulse shown ( Fig.51 Shows Fig.49 and 50Graphs superimposed on each other). The pressure sensed by the proximal pressure measuring device 690 starts at a lower pressure value (about -13psi) and the pressure sensed by the distal pressure measuring device 692 starts at a higher pressure value (about -11psi). This represents a partially blocked system in which the incomplete seal of the thrombus simulant to the catheter allows some flow by producing a slightly lower pressure when measured distally. At time 4, the vacuum is closed and the exhaust valve 650 begins to open. Therefore, the vacuum in the cavity 662 begins to release. This means that the pressure at the proximal pressure measuring device 690 begins to increase, which is evidenced by the upward curve starting at about 4'. Soon after, as the pressure change propagates distally downward to the catheter 660, the pressure at the distal pressure measuring device 692 begins to increase, which is evidenced by the upward curve starting at about 4'. At time 6, the exhaust valve 650 begins to close, and therefore, no more exhaust liquid 642 enters the manifold 630 to increase or increase the fluid column in the cavity 662. Nevertheless, as the vacuum (negative pressure) is completely removed or compensated by the pressure of the exhaust liquid 642, the pressure at the proximal pressure measuring device 690 continues to rise. The pressure at the proximal pressure measuring device 690 reaches a peak, and as shown in FIG. Fig.50 As shown, the pressure at the peak is at a positive pressure of approximately 2 psi – this occurs even though the aspiration thrombectomy system 600 is not actively applying any positive pressure to the fluid or chamber 662. Rather, this pressure level >0.0 psi is due to the momentum of the fluid traveling within the chamber 662. Therefore, the positive pressure within the chamber 662 is acceptable, but needs to be suppressed before it reaches the distal end. At time 8, the exhaust valve 650 has closed and the vacuum valve 620 begins to open at approximately the time of the peak pressure at the proximal pressure measuring device 690. The opening of the vacuum valve 620 reduces the pressure within the chamber 662 and prevents any increase in pressure at the proximal pressure measuring device 690 (if not prevented at this level, the pressure at the distal pressure measuring device 692 would likely be >0.0 psi, meaning that distal forward flow would flow out of the distal end). The subsidence of the pressure pulse is demonstrated by reviewing the pressure trace of the distal pressure measuring device 692. As shown in Fig.50As can be seen in the graph of , the increase in pressure at the distal pressure measuring device 692 follows the increase in pressure at the proximal pressure measuring device 690. At time 8, the pressure recorded at the distal pressure measuring device 692 is still negative (approximately -5 psi), but is rising. As the vacuum continues to operate and exceeds time 9 (when the vacuum valve 620 is fully opened), the peak pressure measured by the distal pressure measuring device 692 at the distal end 664 is less than 0.0 psi (horizontal dashed line), which means that the pressure pulse is subsided and the liquid from the distal portion does not leave the distal end 664, in other words, there is essentially no forward flow. The ROAR effect allows the thrombus simulant to maintain a seal against the catheter, and the system 600 is able to achieve a full vacuum of -13 psi at both measurements. Since the distal pressure is almost released to zero, but a vacuum of -13 psi is quickly achieved, the pressure difference shown is approximately 13 psi.

[0251] As described herein, flow can be forced from the distal end 664 of the conduit 660 while cycling between vacuum and exhaust. The rapid switching between vacuum and exhaust creates forward flow pressure pulses in the fluid column which, if not controlled, will force the fluid column away from the distal end 664 of the conduit 660. Waves travel through the fluid column at very high speeds in the medium. The speed is primarily a function of the fluid density, system compliance (bulk modulus), and the length of the fluid column. To prevent these waves from forcing the fluid column away from the conduit, the system is considered as a whole and the parameters of the valve switching cycle are set so as to control the force that causes the fluid column to flow. To ensure that the fluid column does not leave the distal end 664 of the conduit 660, it is important to tune the conduit 660, any extension tube connected to the conduit 660, the controller 700, and the valve sequence as a system.

[0252] The tuning process has at least two goals: to prevent the pressure waves generated during the ROAR operation from causing forward flow, and to optimize the ROAR effect. The length of the fluid column is critical to the tuning of the system. The pressure wave moves rapidly within the fluid column. The time it takes for the wave to reach the distal end of the catheter is a function of the velocity and the length of the fluid column. The velocity is a function of the density of the fluid within the column and the bulk modulus of the catheter and extension tube. The bulk modulus refers to the compliance of the system: the radial and longitudinal flexibility of the catheter and extension tube. The density of the fluid column is not as important as the bulk modulus unless it varies greatly, such as when there are gaseous (air) bubbles in the fluid column. Therefore, it is very important to clear all the air in the system before implementing the ROAR operation. For a given catheter and extension tube configuration, the bulk modulus and length of the system are fixed. Compliance can be added to the system to change the velocity and thus tune the timing of the pressure wave. For example, a flexible length of tube can be added in line on a relatively rigid catheter and extension tube. When a pressure pulse occurs during a ROAR operation, the flexible length of tube will expand. This reduces the bulk modulus of the system and reduces velocity, thereby slowing the pressure wave and increasing its transit time to the distal end of the catheter. Compliance can also be increased in other ways, such as by including a spring-supported piston in a hole that communicates with the catheter lumen so that the pressure wave displaces the piston, increasing the compliance of the system. By manipulating compliance and valve timing, the system can be tuned for many different combinations of catheters and extension tubes. Careful tuning can result in a resonant state. If the suction and release pulses in the catheter are tuned to match the natural frequency of the clot, an enhanced ROAR effect can be achieved.

[0253] Tuning can be done statically or dynamically. A statically tuned system is tuned so that the conduit 660 (and any extension tubing connected to the conduit 660) is tuned in a fixed valve sequence (e.g. Fig.29 and 30) cooperates with the controller 700. The controller 700 senses the presence of the catheter 660 when it is attached and verifies that the catheter is the correct one for the tuning sequence of the controller 700. If the correct catheter is not sensed, the tuning sequence will not be initiated. In contrast, the dynamically tuned system is tuned during operation. Prior to operation, a valve sequence is initiated that produces a series of pressure pulses in the catheter 660. Sensors on the catheter 660 and / or the extension tube, such as strain gauges, detect these pulses and are used to adjust the parameters of the controller 700 operation to produce the ROAR effect. The catheter 660 contains key data, such as its length, and transmits it to the controller 700. Using this tuning, any catheter within the limits can be used without causing a fluid column to flow out of the distal end 664 during the ROAR operation. Alternatively, the catheter 660 and extension tube can be tuned at the manufacturer, and the details of the valve timing can be transmitted to the controller 700 via the catheter 660.

[0254] In an exemplary embodiment, the valve sequence is as follows: The vacuum valve 620 is closed; After a period of time, the exhaust valve 650 opens; After a period of time, the exhaust valve 650 is closed; After a period of time, vacuum valve 620 opens; and After a while, the sequence is repeated.

[0255] When the exhaust valve 650 is opened, a small amount of exhaust liquid 642 enters the system and creates a pressure pulse. If the exhaust valve 650 is not closed and the vacuum valve 620 is not opened before the pulse reaches the distal end 664 of the conduit 660, the fluid column will flow forward away from the distal end 664 of the conduit 660. In order to prevent the fluid column from flowing out of the conduit 660, the system must be tuned for the time it takes for the pressure pulse to traverse the conduit. In addition, the pressure pulse generated by closing the vacuum valve 620 under flow conditions will cause a pressure increase that must be quenched by opening the exhaust valve 650 before it causes forward flow.

[0256] Tuning is accomplished by selecting appropriate times for the vacuum cycle and the exhaust cycle. In this regard, the vacuum cycle includes the Vacon time 622, the Vacon duration 624, the Vacoff time 626, and the Vacoff duration 628, and the exhaust cycle includes the Vnton time 652, the Vnton duration 654, the Vntoff time 656, and the Vntoff duration 658. Thus, referring to Fig.52Tuning is described. The cycle time is the duration of the entire cycle repetition. At 8 Hz, the cycle time is 125 ms, and at 12 Hz, the cycle time is 83.33 ms. The cycle time is determined by adding the first and second times in the Vacon duration 624, the Vnton duration 654, and the cycle in which both the vacuum valve 620 and the exhaust valve 650 are closed (called the "double shut-off" or "double closed" time or state). The cycle time is optimized by the dynamics or resonance of the specific catheter 660. The Vacon duration 624 must be long enough to enable the system to be evacuated to full vacuum, and the longer the vacuum duration in a specific cycle, the better the suction of the thrombus 4. In this embodiment, only opening the vacuum valve is called the "vacuum only" state. The first double closed time, that is, the time after the vacuum is shut off (the vacuum valve 620 is closed) until the exhaust begins (the exhaust valve 650 is opened), has an impact on the extent to which forward flow occurs. Since this is a short time, this forward flow is called flow burping. Through experimentation, an exemplary embodiment of a 0.071" inner diameter catheter 660 experienced a flow pause when the first double off time was greater than approximately 30 ms; the longer the double off time, the greater the flow pause. During ROAR operation, the first double off time was approximately 10 ms; therefore, this was significantly less than the flow pause threshold, meaning that essentially all forward flow was quenched. The Vnton duration 654 is determined by the maximum time that occurs before the blocked clot 4 drops from the forward flow. The ratio between the Vnton duration 654 and the second double off time is a compromise between the maximum Vnton time 654 and the minimum of the first double off time. In this embodiment, only opening the exhaust valve is referred to as an "exhaust only" state. Finally, with respect to the second double off time, the exhaust valve 650 is closed (fully closed) before the vacuum valve 620 opens and the vacuum resumes.

[0257] about Fig.53The valve position graph in further illustrates the calculation. Starting from the left side of the graph, at the Vacon time 622 the exhaust valve 650 is closed and the vacuum valve 620 is opened. The Vacon duration 624 is long enough to evacuate the system 600 to a full vacuum (at about 10 ms to about 50 ms, particularly about 30 ms). The longer the Vacon duration 624, the better the performance of the catheter 660 because the flow rate in the proximal direction increases. There is a tradeoff based on obtaining a higher frequency on the clot 4 to achieve more hits / second. In an exemplary embodiment, the Vacon duration 624 calculated from the Vacon time 622 to the Vacoff time 626 is about 40% to about 60% of the cycle time 629. As described above, the cycle time 629 is the minimum value determined by the sum of the Vacon duration 624 plus the first double closing time 625 and the second double closing time 627 plus the Vnton duration 654. The Vnton duration 654 is short enough to fill the cavity with exhaust liquid without causing forward flow (between about 10 ms and about 50 ms, especially about 30 ms). The first double closing time 625 is set based on when the opening dynamic flow interval occurs. The maximum value of the first double closing time 625 is applicable to any shorter period from the Vacoff time 626 to the Vnton time 652 or from the Vacoff time 626 to the Vacon time 622 '. Each of these values ​​is optimized by the dynamics / resonance / compliance / length of the specific conduit 660 and the extension device.

[0258] From this, some observations can be made. When the exhaust is opened, a pressure pulse is generated. It is important to stop the pressure pulse before it reaches the distal end. If the pressure pulse is not stopped before it reaches the distal end, the catheter 660 will experience forward flow. The way to stop the pressure pulse is to turn off the exhaust and / or reopen the vacuum if the vacuum is turned off before the exhaust. If the vacuum remains on, the exhaust needs to be turned off. Alternatively, if the vacuum does not remain on, the exhaust needs to be turned off and the vacuum turned back on before the pressure pulse reaches the distal end 664. In other words, the exhaust needs to be turned off before the pressure pulse reaches the distal end 664, and the vacuum must be turned on. Therefore, the condition of simply opening the vacuum valve 620 when the exhaust valve 650 is open may not be sufficient to quell the pressure pulse because the resistance between the exhaust and the vacuum is low; the exhaust will overwhelm the vacuum, so the vacuum will not have an effect throughout the length of the catheter. The time required for the pressure pulse to propagate to the end of the catheter 660 and then cause forward flow is used to define the time that the exhaust valve 650 remains open. The time that the exhaust remains open is selected to be shorter than the time required for the pressure pulse to propagate to the distal end 664.

[0259] exist Fig.55In the exemplary embodiment illustrated in FIG. 6 , all parts of the aspiration thrombectomy system 600, except for the ROAR catheter 660, are incorporated into the body 601 of the vacuum source 610. In particular, the vacuum source 610 includes the body 601, the collection canister 612, and the vacuum motor 614. The vacuum motor 614 is fluidly connected to the outlet of the collection canister 612, and the input port of the collection canister 612 is fluidly connected to the vacuum side of the manifold 630. Therefore, the vacuum generated by the vacuum motor 614 imparts a vacuum to the collection canister 612 to draw fluid from the manifold 630 into the collection canister 612, but not into the vacuum motor 614. The vacuum valve 620 present at the manifold 630 prevents the input fluid received at the manifold 630 from entering the collection canister 612 and isolates the vacuum generated by the manifold 630 and the vacuum motor 614. The exhaust liquid reservoir 640 containing the exhaust liquid 642 is fluidly connected to the exhaust side of the manifold 630. The presence of the exhaust valve 650 at the manifold 630 isolates the manifold 630 from the exhaust liquid 642 and prevents the liquid in the manifold 630 from entering the exhaust fluid reservoir 640 (since the pressure in the manifold 630 is generally lower than the pressure in the reservoir 640, the liquid from the manifold 630 will generally not enter the reservoir 640). In summary, the conduit input port 631 of the manifold 630 is fluidly connected to the collection tank 612 through the vacuum valve 620 and is fluidly connected to the exhaust liquid 642 in the reservoir 640 through the exhaust valve 650. The conduit input port 631 is fluidly connected to the downstream end of the proximal manifold connector assembly 670. The upstream end of the proximal manifold connector assembly 670 is fluidly connected to the proximal end of the conduit 660.

[0260] about Fig.54 and 55 660 is shown directly connected to the aspiration thrombectomy system 600. The proximal manifold connector assembly 670 connects the proximal end 666 of the ROAR catheter 660 to the manifold 630. Fig.54 In the exemplary embodiment shown, the proximal manifold connector assembly 670 includes a male luer lock fitting 672 that is removably or integrally connected to the manifold 630 (shown in phantom). The assembly 670 includes a ROAR identification (ID) subassembly 680. Fig.54The exemplary embodiment of the ID subassembly 680 shown includes an inductive sensing device or sensor 682 connected to the manifold 630. The inductive sensor 682 detects the presence of an inductive sensing portion 684 present in or integrated with the proximal manifold connector assembly 670. In an exemplary embodiment, the manifold 630 can be used with a variety of different ROAR catheters 660, each type of ROAR catheter having a unique inductive sensing portion 684, and the inductive sensor 682 of the manifold 630 is able to determine the type of ROAR catheter 660 attached. Therefore, by appropriately communicating the type of ROAR catheter 660 to the controller 700, the controller 700 is able to operate the ROAR catheter 660 according to its own unique configuration, thereby producing a ROAR effect for each different ROAR catheter 660 used. Nevertheless, when the sensor 682 does not detect the sensing portion 684 and the aspiration thrombectomy system 600 is operated, the controller 700 will automatically prevent the ROAR operation of the aspiration thrombectomy system 600, and the connected catheter will only operate as a standard vacuum catheter.

[0261] about Fig.56 The indirect connection of the catheter 660 to the aspiration thrombectomy system 600 is illustrated. The proximal manifold connector assembly 670 may simply be Fig.54 The accessory 672 shown in the figure, or it can be or can include a separate extension line 674 between the catheter input port 631 and any catheter 660 (standard or ROAR) to be used with the aspiration thrombectomy system 600. In an exemplary embodiment of the extension line 674, the extension line 674 not only includes a lumen extension for aspiration through the catheter 600, but the extension line 674 also includes system controls for operating the aspiration thrombectomy system 600. These controls include, for example, turning the vacuum motor 614 on and off and turning on ROAR operation (e.g., each of these has a button, or an on / off switch for vacuum and a push-to-start button for ROAR). As shown in FIG. Fig.56 As shown, the extension line 674 has a distal end that can be connected to both a standard catheter and a ROAR catheter 600, as both can be used with the aspiration thrombectomy system 600. When a standard catheter is connected to the extension line 674, the aspiration thrombectomy system 660 functions only as a standard vacuum pump, and the ROAR is disabled. When a ROAR catheter 660 is connected to the extension line 674, the identification subassemblies in the ROAR catheter 660 and the extension line 674 inform the system 600 which ROAR catheter 660 and which extension line 674 are connected.

[0262] In an exemplary embodiment with digital control of the vacuum valve 620 and the exhaust valve 650, the processor and memory in the controller 700 store identification data, and upon identifying a specific ROAR catheter (e.g., different length, different outer diameter, different material), the controller 700 loads a valve sequence and operates the vacuum valve 620 and the exhaust valve 650 according to the characteristics of the specific catheter connected to the vacuum source 610. In an exemplary embodiment, the identification data can be pre-programmed at the manufacturer for all currently existing ROAR catheters 660. Thus, by connecting the ROAR catheter 660 directly to the system 600, the controller 700 can operate without receiving any information other than the identity of the catheter 660. If a ROAR extension line 674 is used between the ROAR catheter 660 and the controller 700 (in other words, the extension line is ROAR compatible and is able to inform the system 600 of its enhanced characteristics compared to the enhanced characteristics of the connected ROAR catheter 660), the controller 700 can operate without receiving any information other than the identity of the catheter 660 and the identity of the intermediate extension line 674, because the connection to the ROAR extension line 674 allows the system 600 to detect which specific one of the different ROAR catheters 660 has been connected to the distal end of the ROAR extension line 674 and then use the ROAR extension line 674 to operate the ROAR in a predetermined manner appropriate for that specific ROAR catheter 660. In the case of RFID or near field communication (NFC), a chip embedded in the ROAR catheter 660 is programmed with the specific valve timing required for that catheter 660. The controller 700 reads these values ​​and functions appropriately for that catheter 660. This ensures future compatibility with new generation catheters that require different tuning that was unknown when the controller 700 was programmed at the manufacturer. If the catheter to be used is not a ROAR catheter 660, ROAR should not be used with that catheter because of the high likelihood of forward flow at the distal end. Therefore, when a non-ROAR catheter is connected to the distal end of a ROAR extension line 674 or directly connected to the system 600 or connected to the distal end of a non-ROAR extension line 674, the system 600 automatically prevents the use of the ROAR effect.

[0263] The identification subassembly includes various measures present at least at the proximal end of the ROAR catheter 660 (e.g., an inductive sensing system 682, 684 or a 1-wire detection system such as a DALLAS semiconductor encryption chip, RFID, Bluetooth Low Energy (BLE), a metal touch pad, a simple passive design based on a resistor (in series for catheters and extensions, to name a few)). In the subassembly, there may be two or more electrical contacts. For example, there may be three contacts including power, ground, and signal using a Hall sensor. In a two-contact configuration, there may be a 2-wire configuration using a resistor and a mechanical switch. The resistance between the two contacts may be measured, and the state of the switch may be detected based on the resistance. For example, using the above-mentioned DALLAS chip, power and signal may be combined on one line (plus an additional ground line) to establish a "one-wire" connection. The identification subassembly may also be present at a distal connection (e.g., a Luer fitting) of the extension tubing 674 (to contact the identification subassembly at the proximal end of the ROAR catheter 660) and extend back through the extension tubing 674 to a communication connection with the vacuum source 610, e.g., the proximal manifold connector assembly 670. Thus, the aspiration thrombectomy system 600 has the ability to sense / detect when the connection of the ROAR catheter 660 is different from a standard catheter (i.e., non-ROAR). The connection of the ROAR catheter 660 enables the use of the ROAR function; the connection of a non-ROAR catheter (or, for example, to a side port of a rotary hemostasis valve (RHV)) does not enable the use of the ROAR function, and only normal aspiration is available. In the case where the identification subassembly includes electrical contacts in the ROAR catheter 660, the conductive connection to the vacuum motor 614 can utilize one or more coils of the ROAR catheter 660 as one of these conductors. Alternatively, two or more conductors can be encased within the ROAR catheter 660. Alternatively or additionally, the conductor may be incorporated on the exterior of the ROAR catheter 660 .

[0264] In addition to the exemplary embodiment in which the system 600 has stored the operating parameters for performing aspiration and automatically uses these parameters when the ROAR catheter 660 and / or extension line 674 is connected or provides the operating parameters for performing aspiration at the ROAR catheter 660 or extension line 674, optional programs can be provided to the user in the controller. In an exemplary embodiment, these optional programs can be programmed at the place where the controller 700 is manufactured. The user has an instruction manual that associates the specific ROAR catheter 660 and / or extension line 674 being used with a code that loads the operating parameters (such as pressure, delay, timing). Instead of the instruction manual, these operating parameters can be manually entered by the user, rather than through the optional program, for example, by reading the instructions for use (IFU) or information on the packaging of the system 600, ROAR catheter 660 or extension line 674. In addition, if the user has a desired operating method (e.g., adding a specific timing), the user can directly enter the parameters through the user interface on the system 600. In other exemplary embodiments, the code provider (e.g., a QR code, a barcode, or an RFID chip) can be on the packaging of one or more components, and the user presents the code provider to the controller for reading. In this regard, the system 600 includes a barcode reader and / or a QR code reader and / or an RFID communication device. In another exemplary embodiment, using a display on the system 600, the screen presents the parameters to the user, and these parameters can be fixed or changed by the user. In other words, the user can accept or change the parameters shown. In a particularly inexpensive embodiment, the parameters can be "stored" on a punch card provided by the ROAR catheter 660 or extension tubing 674, and the system 600 has a punch card reader. In this embodiment, the user inserts an inexpensive card (e.g., provided with a cover to protect it from the liquids present in the operating room) into the card reader, and the controller 700 uses the parameters on the card or uses a code on the card that is associated with a set of stored parameters.

[0265] All of these embodiments can present the operator with a selection of alternative programs or parameters, or the system 600 can list the parameters to be used separately on a display screen, and then allow the operator to select those parameters or change the parameters provided. Similarly, the operator can store parameters / programs in an empty memory in the controller 700. The stored information provided by the catheter, extension line, card, code, etc. can be ROAR parameters, or alternatively, the information can be the characteristics of the catheter and extension line, so that the controller 700 can compensate to provide a predetermined ROAR waveform at the end of the catheter. In other words, the catheter and extension line do not provide a stored ROAR program, but can simply provide information to the controller 700, so that the timing and pressure of each catheter / extension line combination can be modified to achieve a predetermined ROAR pressure / time profile. By storing compensation parameters or actual time / pressure parameters, the controller 700 can allow future catheters and extensions that are not yet available. Additionally, the chip, resistor, RFID or BLE is used to prevent system 600 from being used with catheters not provided by the manufacturer of system 600, and / or to present a warning or alarm condition to the operator to let them know that the catheter and / or extension is not supported by system 600.

[0266] An exemplary embodiment of a proximal manifold connector assembly 670 includes an extension tube 674 having a system control board 676 having Fig.56 Remote control 678 shown. An exemplary embodiment of remote control 678 is a mechanical slide switch that turns vacuum on or off based on longitudinal position. This can be a two-position switch with a button for ROAR operation. Alternatively, a three-position switch can be provided. In the forward position, the vacuum is off; in the middle or intermediate position, the vacuum is on; in the rearward position, ROAR operation occurs. When the remote switch is connected, any control buttons on the pump are disconnected, but the "emergency off" switch on the pump allows the user to turn off the pump when needed, regardless of the operation of the remote control. LEDs can be set on the remote control 678 and / or the body 601. For example, these LEDs can be: red = off, green = vacuum on, flashing green = ROAR, flashing red = error, blue = exhaust / purge. In an exemplary embodiment, a mechanical redundant clamping valve abuts against the catheter, and when actuated, the mechanical redundant clamping valve clamps the lumen of the catheter. In this exemplary embodiment, the distal end of the proximal manifold connector assembly 670 connected to the ROAR catheter 660 includes a Luer lock component that is connected to another Luer lock component on the ROAR catheter 660. In various exemplary embodiments, the switch is a passive switch (e.g., a simple mechanical switch) or an active switch (e.g., capacitive, pressure, magnetic). In this case, the switch is powered by a wire through the extension line 674. In an alternative embodiment, the switch is a separate module attached to the extension line 674, for example, powered by a battery.

[0267] The first benefit of the aspiration thrombectomy system 600 is that with this configuration, the same vacuum source 610 can be used with all catheters that could previously be connected to any surgical suction device / vacuum pump. The second benefit relates to the safety of achieving the ROAR effect. In such a configuration, the user is persuaded to connect the proximal end of the ROAR catheter 660 to the distal end of the proprietary extension line 674. This is beneficial for a variety of reasons. First, ROAR will not function unless the two unique ROAR components are directly connected and a positive ROAR ID is established. Second, if a standard rotary hemostatic valve is connected between the ROAR catheter 660 and the extension line 674 (for any reason the surgeon / nurse may have), the identification will be negative and ROAR will be disabled. There is a risk that the fluid contained within the lumen of such a rotary hemostatic valve may enter the fluid column of the ROAR catheter and thereby introduce air bubbles that need to be completely purged from the system for use. The RHV 609 increases the likelihood of air being trapped in the lumen or entering the fluid system. See Fig.72 . Thus, one particularly desirable configuration for the ROAR catheter 660 is a direct connection between the proximal end of the ROAR catheter 660 and the distal end of the proprietary extension tubing 674. There is also the safety issue of ensuring that the ROAR effect is only used with a ROAR catheter 660. As described above, each ROAR catheter 660 has a specific set of properties related to compliance, and therefore, the operation of the vacuum valve 620 and the exhaust valve 650 are set for that set of properties. The system 600 is set to react to a specific ROAR configuration based on the physical properties of the connected ROAR catheter 600, such as length and lumen size. Thus, the system 660 is tuned / programmed to store a given ROAR setting for each ROAR catheter 660.

[0268] However, it is possible that a new ROAR conduit 660 and a new ROAR extension line 674 may be created after the system 600 or controller 700 is placed into the field. Therefore, providing the identity of the ROAR conduit 660 or the ROAR extension line 674 will not be sufficient to allow those components to operate properly. Therefore, in an additional or alternative embodiment, each of the ROAR conduit 660 and the ROAR extension line 674 is equipped with a memory device (e.g., a DS28E07 EEPROM memory chip) that, when connected to the system 600, provides the controller 700 with the variables required for that ROAR conduit 660 and / or that ROAR extension line 674 to operate under the ROAR effect. Example variables stored in the memory of each ROAR conduit 660 and ROAR extension line 674 include, but are not limited to, the frequency of the waveform cycle, the time in the cycle when the vacuum is on (Vacon time 622), the duration of the vacuum (Vacon duration 624), the time in the cycle when the vacuum is off (Vacoff time 626), the duration of vacuum off (Vacoff duration 628), the time in the cycle when the exhaust is on (Vnton time 652), the duration of the exhaust (Vnton duration 654), the time in the cycle when the exhaust is off (Vntoff time 656), and / or the duration of the exhaust off (Vntoff duration 658). By being able to provide such information to the controller 700, the system 600 can take advantage of any future ROAR conduits 660 and / or ROAR extension lines 674 that may be created for the system 600.

[0269] An exemplary embodiment of a self-contained aspiration thrombectomy system 600 is shown in Figures 57 to 71 The system 600 has an outer body 601 including a vacuum motor 614, a controller 700, and control means for a vacuum valve 620 and an exhaust valve 650 (an exemplary embodiment of a control means for the valves is shown in FIG. Fig.29 and Figures 42 to 46 614). The vacuum motor 614 is fluidly connected to the collection tank 612 (illustrated in dashed lines). The body 601 houses a set of system controls 676 (in alternative embodiments, the controls 676 may be located on / also on the extension tubing 674). In the exemplary embodiment, there are three buttons: "Off", "Purge", and "ROAR / Vac". (The purge function will be described in further detail below.) On the opposite side of the collection tank 612 is the exhaust fluid reservoir 640 (illustrated in dashed lines) which contains exhaust fluid 642. As described above, the fluid path of the catheter 660 is always free of bubbles / air during the procedure.

[0270] The body 601 has a cartridge connection assembly 602 on its front surface. The cartridge connection assembly 602 protrudes from the front surface and has an outer shape substantially the same as the cartridge 710 to be attached thereto. The vacuum valve 620 and the exhaust valve 650 protrude from the front surface 608 of the cartridge connection assembly 602 and, in an exemplary embodiment, are centered in the corresponding recesses of the cartridge connection assembly 602. In this embodiment, the vacuum valve 620 and the exhaust valve 650 are pistons with a clamping structure at their farthest ends. In this exemplary embodiment, the clamping structure is generally in the shape of a standard slot screwdriver. When the vacuum piston and the exhaust piston extend a given distance (e.g., 8 mm) from the recess, the groove presses against the tube (in the cartridge 710) to close the cavity in the corresponding vacuum or exhaust hose. The effect of closing the hose is to close the corresponding valve, and the effect of loosening the hose is to open the vacuum or exhaust, respectively. Therefore, if the hose for each vacuum line and exhaust line is placed directly in front of the piston, the valves 620, 650 will control the vacuum and exhaust according to the ROAR process described herein. (As described below, the cassette 710 positions the hoses in this manner.) Between the valves 620, 650 is a boss 604 that protrudes from the front surface 608 of the cassette connector assembly 602. The boss 604 has an outer surface with a given shape, such as a raceway, and directional wings 605. At the end of the boss 604 is a swivel lock 606 that is semicircular or semi-elliptical in shape. The swivel lock 606 has a central pivot to allow it to be moved from the Figures 57 to 67 604. The position shown in FIG. 604 is rotated 90 degrees. Therefore, in the rotation direction, the rotation lock 606 defines a lower surface (relative to the front surface 608 of the box connection component 602) perpendicular to the protruding range of the boss 604. These lower surfaces are arranged at a certain distance to define the gap between the lower surface of the rotation lock 606 and the front surface 608 of the box connection component 602. There is also a conductive connector 618 on the front surface 608 of the box connection component 602. The conductive connector 618 is used to detect when the box 710 exists and is locked on the box connection component 602. The detection of the box 710 can be carried out by mechanical measures (such as spring pins) or a combination of mechanical and optical and electrical measures.

[0271] The cartridge 710 is removably connected to the cartridge connection assembly 602, and an exemplary embodiment of the cartridge 710 is shown in FIG. Figures 68 to 71 In. Fig.68 As shown, the box 710 has an internal aperture 712, the shape of which corresponds to the given shape of the boss 604. The shapes of the boss 604 and the internal aperture match so that the box 710 can be assembled on the boss 604 and slid downward thereon until the rear surface of the box 710 is aligned with and / or in contact with the front surface 608 of the box connection component 602. Fig.69 The rear surface of the box 710 is depicted in FIG. Fig.69In the view of FIG. 7 , there are pockets 714 in the inner surface of the box 710 at the inner orifice 712 that correspond to the shape of the directional wings 605. In this regard, when the box 710 is slid down from the boss 604, there is only one orientation in which the box 710 can approach the front surface 608 in the lowest position (e.g., in a key in a keyhole). This placement ensures that the distal effectors of the vacuum valve 620 and the exhaust valve 650 are always aligned with the vacuum valve area 720 and the exhaust valve area 750 within the box 710.

[0272] When the "T" shape of the boss 604 and wing 605 matches the internal T-shape of the orifice 712, three connections become possible. First, as described above, the distal effectors of the vacuum valve 620 and exhaust valve 650 are aligned with the vacuum valve area 720 and exhaust valve area 750 within the box 710. Second, the conductive connectors 718 on the back of the box 710 are aligned and contacted with the corresponding conductive connectors 618 adjacent to the boss 604. These connectors 718, 618 can be, for example, corresponding pads and spring pins to ensure that a positive electrical connection is achieved when the box 610 is locked to the box body 611 using the rotation lock 606. With appropriate electrical connections, these connectors 718, 618 can inform the controller 700 that the box 710 is installed and ready for use, and if it is associated with a specific ROAR catheter 660 and identification is required, then which box 710 is installed. Finally, the rotary lock 606 is positioned above the front face 608 of the cartridge connection assembly 602, and the bottom surface of the rotary lock 606 is positioned above the outer front surface 716 of the cartridge 710. The protruding distance of the boss 604 is configured to place the bottom surface of the rotary lock 606 (the surface facing the front surface 608) at a distance approximately equal to the thickness of the cartridge 710, so that as the lock 606 is rotated, the bottom surface of the rotary lock 606 engages the outer front surface 716 of the cartridge 710, thereby pressing the cartridge 710 firmly into place against the front surface 608, bringing the connectors 718, 618 into contact, and locking the cartridge 710 to the body 601. The quarter-turn rotary lock 606 secures the cartridge 710 to the body 601 and also provides a cam force that holds the cartridge 710 thereon, particularly when the valves 620, 650 are actuated against the vacuum and exhaust lines present within the cartridge 710. In an exemplary embodiment, a switch, not shown, is integrated into the rotation lock 606 that detects a quarter turn and, along with the electrical connectors 718 , 618 , verifies that the system 600 is armed and ready for use.

[0273] In a particularly effective configuration, the box 710 is provided as a Figures 68 to 71The complete set of junction boxes and tubing sets shown can be removable, replaceable and disposable. Box 710 has a set of relatively short whips of tubing and extension whips, the whips include a first whip 722 fluidly connected to the collection tank 612 of the vacuum source 610 and a second whip 752 fluidly connected to the inlet of the exhaust valve 650, the extension whip can be an extension line 674 or can be a short tube directly connected to the conduit 660. Once connected, this efficient configuration allows the system of chambers to automatically purge air / bubbles. By positioning the exhaust liquid in all chambers (e.g., with Fig.67 Bag 640 in), conduit 660 and collection tank, opening the output port of exhaust fluid reservoir 640 will fill all internal cavities and clear any air / bubbles from the system before use. If necessary, the cam lock can be mechanically connected to the vacuum motor 614 (temporary or fixed), and the motor 614 can be operated to actively draw all air into the collection tank, thereby purging the system 600. As an alternative to the front loading configuration of the box 710, the box 710 can be connected or molded as part of the bottom of the disposable collection tank 612. In this configuration, the two disposable components can be provided together in a sterile package and disposed of in one piece. Use can be either a hard container ( Figure 57 to Figure 61 ) can also be a bag( Figure 62 to Figure 67 ), the exhaust liquid 642 can be part of the cassette 700 with all chambers pre-filled with saline, and part of a single disposable package. One or both of the exhaust liquid reservoir 640 and the collection tank 612 can be part of the disposable cassette 700 system. All disposable components used in the catheterization process can be integrated together in one disposable package.

[0274] As mentioned above, it is important to purge the air in the system to achieve the ROAR effect. Purification can be achieved in several ways. The two main methods used to purge the system are forced purge and dribble purge. The forced purge method includes immersing the end of the extension line 674 in a sterile fluid such as saline and activating the "purge" function while immersing. Then, the controller 700 will alternately open one or two control valves for a predetermined time and sequence to pull the sterile fluid through the extension line 674 and the valve and replace all the air that may be present in the system. Once this purge process is completed, the two valves are closed, and the extension line 674 with a full fluid column can be connected to a catheter that has also been vented and ROAR has been applied. In contrast, the dribble method relies on a small positive pressure (generated by gravity, a squeezed fluid bag, a pressurized exhaust liquid tank, or a peristaltic pump or any similar measure) to dribble the exhaust fluid through the cavity, thereby causing it to overflow. In the exemplary case of the dribble purge system, the exhaust fluid source 640 is higher than the outlet of the extension line 674, and the exhaust liquid path does not contain any air trap.

[0275] For the trickle method, the purge cycle is initiated by pressing the purge button and, in an exemplary embodiment, is performed by the controller 700. With the vacuum valve 620 closed, the vacuum source 610 is turned on and the vacuum container is evacuated to the desired vacuum level. The exhaust valve 650 is opened and the exhaust liquid 642 is allowed to fill the exhaust line and extension line 674. To ensure that all air is exhausted from the manifold 630, the vacuum valve 620 is opened momentarily while the exhaust valve 650 is also opened. This allows the exhaust liquid 642 to be drawn from the exhaust fluid source 640 and the extension line 674 and pass through the vacuum manifold channel, thereby clearing their air. After the vacuum valve 620 is closed, the vent valve 650 remains open for a period of time to ensure that the amount of fluid removed from the extension line 674 by the vacuum cycle is replenished. This cycle of exhaust liquid flow and momentary vacuum can be repeated multiple times to ensure complete purification. The purge pump can be a peristaltic pump, a pressurized cuff around a flexible exhaust liquid container (e.g., an IV bag), and / or an exhaust fluid filter canister that is pressurized using exhaust from the vacuum source 610.

[0276] The presence of bubbles in the fluid system can adversely affect the water hammer effect. Therefore, the system 600 promotes or automatically removes air from the fluid cavity. In an exemplary embodiment, a bubble sensor (based on optical, ultrasonic or fluid pressure curve) is incorporated into the system 600 to promote this removal or automatically implement the removal function (for example, under the control of the operator to prevent removal when the catheter 660 is present in the blood flow). There are many measures for bubble detection. For example, an optical sensor can be placed in the box 710 to sense the presence of bubbles. Using a sensor coupled to the vacuum source 610, a slow increase in pressure can be detected to prevent the use of an incorrect catheter or extension. The specific compliance of the catheter 660 or the extension line 674 is one of the parameters used to program or compensate the system 600. The user feedback indication informs the user when the system has been fully purged. In an exemplary embodiment, the compliance of the catheter 660 and the extension line 674 is controlled to be below a certain optimal range. Similarly, the pressure rise information is used to modify the ROAR settings, for example, to detect blockages and provide an optimal pressure curve for the condition.

[0277] The exemplary configuration of the aspiration thrombectomy system 600 described and shown provides various significant benefits. Before describing these additional benefits, reference is made to Fig.72 , Fig.72An exemplary embodiment of an aspiration thrombectomy system 600 and a catheter 660 with an extension line 674 is shown. The aspiration thrombectomy system 600 includes a vacuum source 610 with a collection canister 612, an exhaust liquid reservoir 640 with an exhaust liquid 642, a manifold 630, and a proximal manifold connector assembly 670. Removably connected to the proximal manifold connector assembly 670 is a ROAR extension line 674. Immediately adjacent to the ROAR extension line 674 is an off-the-shelf extension line 674' that can be used with the system and can be used with a conventional surgical vacuum source by connecting via the proximal manifold connector assembly 670. The ROAR extension line 674 includes system controls 676, which are also shown on the top surface of the frame of the system 600. A ROAR catheter 660 and an off-the-shelf aspiration catheter 660' are also shown. Both catheters 660, 660' may be used with either extension line 674, 674' via the proximal Luer connector.

[0278] There are several topologies of disposable, reusable, and limited reuse components of the aspiration thrombectomy system 600 as described and illustrated herein. The vacuum source 610 may be a limited reuse component that is inserted into a reusable electronic / power system, such as Fig.72 Frame in. Valve element box 710 includes a clamp tube, so it is a disposable component. Alternatively, the valve assembly can be reusable, for example, in the case where the valve actuator is separate, or in a separate semi-reusable module, or in a part of a pump / control system. Different types of valves (e.g., rotary valves, trumpet valves) have different ways of separating the disposable / reusable parts of system 600. The valve actuator can be part of the reusable part, or part of the limited reuse part (e.g., together with the pump module). Alternatively, or, the valve actuator can be a second limited reuse module. The box 710 with valve elements may include a diaphragm or piston actuated by a mechanical actuator in the reusable part of system 600. Through this modularization, the architecture of system 600 becomes suitable for use with any vacuum source, even a household vacuum system (which may include a vacuum pressure regulator to ensure the uniformity of system 600). The power supply of system 600 can be a rechargeable battery or a replaceable module attached to system 600, in which case the latter does not need to be sterile. Alternatively, the power source is a primary battery included as part of a disposable component, which may include a disposable pumping element.

[0279] The various configurations allow for multiple product topologies that are tailored to different use cases. For example, one topology is a system with minimal recurring costs where only the tubing set is disposable. Alternatively, another topology is a system that requires minimal capital costs and incorporates modules whose costs are easily amortized for each surgical case.

[0280] Various additional safety measures may be added to the system 600. For example, a level detector may be provided at or with the exhaust fluid reservoir 640 to confirm that the exhaust liquid 642 is in the tank or bag to indicate a warning to the user when the exhaust liquid level is low, and to prevent operation of the system 600 if the exhaust liquid is running low or is empty. In a configuration with a cartridge 710, the system 600 will not start unless the cartridge 710 is in place and properly installed. The system 600 may have a purge function for filling the various cavities of the conduit 660, extension line 674, and any tubes connecting the exhaust fluid reservoir 640 and the collection tank 612 before use. Note that the system 600 should not be operated if there is air anywhere in the cavity. Therefore, the controller 700 may set a stage before use to operate the system to aspirate the exhaust liquid 642 and fill the various cavities. This may include operating the vacuum motor 614 in reverse to apply positive pressure for purging the various cavities. Alternatively, the controller 700 can actuate a peristaltic pump to purge exhaust fluid through the chambers. The controller 700 can be programmed during operation of the system 600 to detect peaks in usage during ROAR. If these peaks are not significant, a conclusion that air is present in the system can be determined. Bubble detectors (i.e., ultrasonic) can be added to the system so that they straddle the tubing in the box and provide feedback to the controller to ensure that the tubing has been properly purged. Using such a conclusion, the controller 700 can be programmed to stop operation and initiate an automatic purge procedure to flush the various chambers using an external liquid source or from the exhaust fluid reservoir 640.

[0281] Note that various individual features of the process and system of the present invention may be described in only one exemplary embodiment herein. The specific description selection of a single exemplary embodiment herein should not be regarded as a limitation that a specific feature applies only to the described embodiment. All features described herein are equally applicable to any or all other exemplary embodiments described herein in any combination or grouping or arrangement, are additions to these exemplary embodiments or are interchangeable therewith. In particular, the use of a single reference numeral to illustrate, define or describe a particular feature herein does not mean that the feature cannot be associated or equivalent with another feature in another figure or description. In addition, where two or more reference numerals are used in a figure or figure, this should not be interpreted as being limited to only those embodiments or features, and they are equally applicable to similar features or not using a reference numeral or omitting another reference numeral.

[0282] The foregoing description and accompanying drawings illustrate the principles, exemplary embodiments, and modes of operation of the systems, devices, and methods. However, the systems, devices, and methods should not be construed as being limited to the specific embodiments discussed above. Other variations of the embodiments discussed above will be appreciated by those skilled in the art, and the above embodiments should be considered illustrative rather than restrictive. Therefore, it should be understood that those skilled in the art may make variations to those embodiments without departing from the scope of the systems, devices, and methods defined by the appended claims.

Claims

1. A suction thrombus removal system, comprising: an aspiration catheter having a proximal portion, a distal end, and a lumen extending through the catheter; a vacuum source fluidly coupled to the conduit; a vacuum valve connected between the vacuum source and the proximal portion of the catheter to control vacuum flow within the lumen of the catheter; an exhaust valve fluidly coupled to the proximal portion of the catheter, the exhaust valve configured to control exhaust fluid flow within the lumen of the catheter; as well as A controller is configured to open and close the vacuum valve and the exhaust valve in a cycle to vary the vacuum level at the distal end of the catheter and cyclically cause flow into and out of the distal end of the catheter.

2. The system of claim 1 , further comprising a source of exhaust fluid, and wherein: The exhaust fluid source is configured to provide exhaust fluid at a pressure greater than atmospheric pressure; as well as The controller is configured to cyclically open and close the vacuum valve and the exhaust valve to vary negative and positive pressure levels at the distal end of the catheter during each cycle.

3. A system according to claim 2, wherein the controller is constructed to cyclically open and close the vacuum valve and the exhaust valve so that the movement of the fluid column at the distal end of the catheter is limited to an outlet flow range of about 0.001 ml to about 1.0 ml before the fluid is drawn back into the cavity of the catheter.

4. A system according to claim 2, wherein the controller is constructed to cyclically open and close the vacuum valve and the exhaust valve so that the movement of the fluid column at the distal end of the catheter is limited to an outlet flow rate of about 0.1 ml to about 0.5 ml before the fluid is drawn back into the cavity of the catheter.

5. The system of claim 1 , wherein the controller is configured to cyclically open and close the vacuum valve and the exhaust valve in a repeating cycle including a double closed state in which the vacuum valve is closed while the exhaust valve is closed.

6. The system of claim 1, wherein: The controller is configured to cyclically open and close the vacuum valve and the exhaust valve in a cycle including: (a) a first double closed state in which the vacuum valve is closed and the exhaust valve is closed; (b) a vacuum-only state following the first double closed state in which the vacuum valve is open and the exhaust valve is closed; (c) a second double closed state following the vacuum-only state in which the vacuum valve is closed and the exhaust valve is closed; and (d) an exhaust-only state following the second double closed state in which the vacuum valve is closed and the exhaust valve is open; and The cycle is repeated.

7. The system of claim 6, wherein the cycle is repeated at a frequency of 2 Hz to 12 Hz.

8. The system of claim 6, wherein the second double closed state lasts for a predetermined time that is less than a time for a pressure pulse to propagate to the distal end of the catheter after closing the vacuum valve.

9. The system of claim 1, wherein the vacuum valve and the exhaust valve are solenoid-actuated pinch valves.

10. The system of claim 1, wherein the vacuum valve and the exhaust valve are cam pinch valves.

11. The system of claim 1 , wherein the controller is configured to cyclically open and close the vacuum valve and the exhaust valve such that momentum transfer of the fluid column within the lumen of the catheter is sufficient to loosen thromboembolic material at the distal end of the catheter.

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