Hemostasis valve

Abstract

A hemostasis valve may be used with an aspiration and / or thrombectomy catheter. The hemostasis valve can be moved between a first configuration in which the valve lumen is closed and a second configuration in which the valve lumen is open. The hemostasis valve can comprise a frame, a collapsible tubular sidewall, a first filament, a second filament, a first lever, and a second lever. The first and second filaments can be formed into respective first and second loops around the collapsible tubular sidewall. The first and second filaments may be slidably advanceable around the first and second levers. The first and second levers may be depressed to tension the first and second filaments, causing the first and second loops to circumferentially constrict the collapsible tubular sidewall and close the valve lumen. The hemostasis valve may be biased to the first configuration by a biasing device.

Description

HEMOSTASIS VALVECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 557,439, entitled “HEMOSTASIS VALVE” and filed February 23, 2024, which is hereby incorporated by reference in its entirety.BACKGROUND

[0002] Thrombotic restrictions and occlusions within a patient’s blood vessels are a significant medical problem and often require intervention to remove these restrictions and blockages to restore health to patients. While applicable to a wide range of vascular applications in both the arterial and venous systems, including a variety of small vessels, the following background illuminates the problems primarily through the example of patients suffering with Pulmonary Embolisms.

[0003] Venous thromboembolic disease (VTE) is a worldwide crisis. There are over 10 million cases of deep vein thrombosis (DVT) and pulmonary embolism (PE) diagnosed globally per year, with 1 million cases occurring in the United States and over 700,000 in France, Italy, Germany, Spain, Sweden, and the United Kingdom combined each year. There are approximately 60,000 to 100,000 deaths from PE in the United States each year. DVT and PE are part of the same continuum of disease, with over 95% of emboli originating in the lower extremities. When PE occurs, the severity depends on the embolic burden and its effect on the right ventricle as well as underlying cardiopulmonary comorbidities. Death can result from the acute increase in pulmonary artery (PA) pressure with increased right ventricular (RV) afterload and dysfunction.

[0004] Patients with high-risk pulmonary embolism (PE) are treated primarily with thrombolytic therapy delivered systemically or locally through Catheter Directed Thrombolytics. These approaches result in catheterization lab visits, lengthy hospital stays and often lead to bleeding complications. Newer approaches to PE treatment include single session thrombectomy treatments without the use of thrombolytics. These thrombectomy treatments include delivering a catheter into the PA to remove the thrombus or embolus (clot) through aspiration, and secondary tools may also macerate or disrupt the clot prior to or duringaspiration. While thrombectomy results in fewer bleeding complications and reduced hospital stays compared to thrombolytics, there is much to be improved upon given the challenges of the procedure itself, including the ability to capture a broad spectrum of clot types and reduce the total volume of blood loss during the procedure.

[0005] The thrombectomy catheter is introduced through an introducer sheath in a large diameter vein. A flexible guide wire is passed through the introducer into the vein. The flexible guidewire provides a rail for a flexible guide catheter to be advanced through the right atrium into the right ventricle and into the pulmonary artery. The flexible guidewire is removed and replaced with a stiff guidewire. The large diameter thrombectomy catheter with support dilator is then advanced over the stiff guidewire to the pulmonary artery and the dilator is removed. If the large diameter thrombectomy catheter is not successful in accessing or aspirating thrombus in a more distal portion of the vessel, a smaller diameter catheter may be inserted through the large diameter catheter.

[0006] In addition, peripheral arterial occlusive (PAO) disease occurs in more than 4% of individuals over age 40 and markedly increases in incidence after the age of 70. Acute PAO is usually due to thrombosis of the peripheral vasculature and is associated with a significant risk of limb loss. In order to preserve the limb, therapy for acute PAO centers on the rapid restoration of arterial patency and blood flow such as through mechanical thrombectomy in procedures similar to those described above.

[0007] Clot aspiration using certain commercial vacuum-assisted thrombectomy systems may sometimes need to be terminated due to the risk of excessive blood loss by the patient, especially when using large aspiration catheters. During aspiration thrombectomy, when the catheter tip falls out of contact with the thrombus or other occlusive material, the tip is exposed to healthy blood and full flow of blood through the catheter ensues. Under such conditions, the total volume of blood loss is excessive, and in some cases, may result in premature termination of the procedure. For example, during a procedure when the catheter enters healthy blood and full aspiration flow ensues, the blood loss rate can be on the order of 30-40 cc per second with a 24 French size catheter. The catheter cannot run in unrestricted mode for more than approximately 10 to 15 seconds, the aggregate blood loss may reach an unacceptable level before sufficient clot is removed.SUMMARY

[0008] The systems, methods, and devices described herein have innovative aspects, no single one of which is indispensable or solely responsible for their desirable attributes. Without limiting the scope of the claims, some of the advantageous features will now be summarized.

[0009] The present disclosure provides, among other things, a hemostasis valve. In certain aspects, the hemostasis valve can include a frame, a first lever pivotably coupled to the frame, a second lever pivotably coupled to the frame, a collapsible tubular sidewall housed within the frame, a first filament formed into a first loop around the collapsible tubular sidewall, and a second filament formed into a second loop around the collapsible tubular sidewall. The first lever can comprise a first fulcrum and the second lever can comprise a second fulcrum. The collapsible tubular sidewall can define a valve lumen. The first filament can include a first intermediate portion extending away from the first loop and slidably extending around the first fulcrum and a second intermediate portion extending away from the first loop and slidably extending around the second fulcrum. The second filament can include a third intermediate portion extending away from the second loop and slidably extending around the first fulcrum and a fourth intermediate portion extending away from the second loop and slidably extending around the second fulcrum. The first intermediate portion, the second intermediate portion, the third intermediate portion, and the fourth intermediate portion can extend away from the collapsible tubular sidewall within substantially the same plane. The first filament and the second filament can be wrapped inwardly around the collapsible tubular sidewall towards each other such that the second intermediate portion and the fourth intermediate portion are disposed between the first intermediate portion and the third intermediate portion. The first lever and the second lever can be moveable between a first position in which the first filament and the second filament are tensioned to close the valve lumen by circumferentially constricting the first loop and the second loop around the collapsible tubular sidewall and a second position in which the first filament and the second filament are loosened to least partially open the valve lumen.

[0010] In some embodiments, the hemostasis valve can further comprise a biasing device configured to bias the first lever and the second lever to the first position. The first leverand the second lever can be configured to move to the second position in response to being depressed towards the collapsible tubular sidewall.

[0011] In some embodiments, the biasing device can comprise a first spring coupled to the first lever and a second spring coupled to the second lever.

[0012] In some embodiments, the first intermediate portion and the third intermediate portion can extend away from the collapsible tubular sidewall in a first direction, and the second intermediate portion and the fourth intermediate portion extend away from the collapsible tubular sidewall in a second direction.

[0013] In some embodiments, the first direction is opposite to the second direction.

[0014] In some embodiments, the first filament can further comprise a first tail portion extending from the first intermediate portion and connected to the frame and a second tail portion extending from the second intermediate portion and connected to the frame. The second filament can further comprise a third tail portion extending from the third intermediate portion and connected to the frame and a fourth tail portion extending from the fourth intermediate portion and connected to the frame.

[0015] In some embodiments, the first tail portion and the third tail portion can be coupled together at a first attachment point on the frame, and the second tail portion and the fourth tail portion can be coupled together at a second attachment point on the frame.

[0016] In some embodiments, the first fulcrum can be disposed at a distal end of the first lever and the second fulcrum can be disposed at a distal end of the second lever.

[0017] In some embodiments, the hemostasis valve can further comprise a housing, a first button moveably coupled to the housing, and a second button moveably coupled to the housing. The housing can be disposed around the frame, the first lever, and the second lever. The first button can be actuatable to move the first lever and the second button can be actuatable to move the second lever.

[0018] In some embodiments, the first lever and the second lever can be configured to pivot about axes that are parallel to a longitudinal axis of the collapsible tubular sidewall.

[0019] In some embodiments, the hemostasis valve can be mounted on a proximal end of a catheter.

[0020] In other aspects, the present disclosure provides a hemostasis valve including a frame, a first actuator moveably coupled to the frame, a collapsible tubular sidewallhoused within the frame, a first filament formed into a first loop around the collapsible tubular sidewall, and a second filament formed into a second loop around the collapsible tubular sidewall. The first filament can have a portion extending away from the first loop and coupled to the first actuator. The second filament can have a portion extending away from the second loop and coupled to the first actuator. The collapsible tubular sidewall can define a valve lumen. The portions of the first and second filaments extending away from the first and second loops can extend away from the collapsible tubular sidewall within substantially the same plane. The first actuator can be moveable to pull the portions of the first and second filaments away from the collapsible tubular sidewall to reduce a diameter of the valve lumen by circumferentially constricting the first loop and the second loop around the collapsible tubular sidewall.

[0021] In some embodiments, the hemostasis valve can further include a second actuator moveably coupled to the frame.

[0022] In some embodiments, the portion of the first filament extending away from the first loop is a first intermediate portion, and the portion of the second filament extending away from the second loop is a third intermediate portion. The first filament can further comprise a second intermediate portion extending away from the first loop and coupled to the second actuator. The second filament can further comprise a fourth intermediate portion extending away from the second loop and coupled to the second actuator. The second actuator can be moveable to pull the second intermediate portion and the fourth intermediate portion away from the collapsible tubular sidewall to reduce a diameter of the valve lumen by circumferentially constricting the first loop and the second loop around the collapsible tubular sidewall.

[0023] In some embodiments, the second intermediate portion and the fourth intermediate portion can extend from the collapsible tubular sidewall within substantially the same plane as the first intermediate portion and the third intermediate portion.

[0024] In some embodiments, the first filament and the second filament can be wrapped inwardly around the collapsible tubular sidewall towards each other such that the second intermediate portion and the fourth intermediate portion are disposed between the first intermediate portion and the third intermediate portion.

[0025] In some embodiments, the first actuator can comprise a first lever pivotably coupled to the frame.

[0026] In some embodiments, the first lever can comprise a first fulcrum disposed at a distal end of the first lever. The portions of the first and second filaments can slidably extend around the first fulcrum.

[0027] In some embodiments, the first lever can be configured to pivot about a first pivot axis that is parallel to a longitudinal axis of the collapsible tubular sidewall.

[0028] In some embodiments, the hemostasis valve can further comprise a biasing device configured to bias the first actuator in a direction that places the portions of the first and second filaments under tension to close the valve lumen.

[0029] In some embodiments, the hemostasis valve can further comprise a housing disposed around the hemostasis valve, and a first button moveably coupled to the housing. The first button can be actuatable to move the first actuator.

[0030] In yet other aspects, the present disclosure provides a hemostasis valve including a frame, a first lever pivotably coupled to the frame about a first pivot axis, a second lever pivotably coupled to the frame about a second pivot axis, a collapsible tubular sidewall housed within the frame, and a first filament formed into a first loop around the collapsible tubular sidewall, the collapsible tubular sidewall can define a valve lumen extending along a longitudinal axis of the collapsible tubular- sidewall. The first filament can be coupled to the first lever and the second lever. The first pivot axis and the second pivot axis can be substantially parallel to the longitudinal axis of the collapsible tubular sidewall.

[0031] In some embodiments, the first lever can comprise a first fulcrum disposed at a distal end of the first lever, and the second lever can comprise a second fulcrum disposed at a distal end of the second lever.

[0032] In some embodiments, the first filament can comprise a first intermediate portion extending away from the first loop and slidably extending around the first fulcrum and a second intermediate portion extending away from the first loop and slidably extending around the second fulcrum.

[0033] In some embodiments, the first intermediate portion and the second intermediate portion can extend away from the first loop within substantially a same plane.

[0034] In some embodiments, the first pivot axis is the same as the second pivot axis.

[0035] In some embodiments, the first lever and the second lever can be moveable between a first position in which the first filament is tensioned to close the valve lumen by circumferentially constricting the first loop around the collapsible tubular sidewall and a second position in which the first filament is loosened to least partially open the valve lumen.

[0036] In yet other aspects, the present disclosure provides a hemostasis valve including a frame, a first lever pivotably coupled to the frame, a second lever pivotably coupled to the frame, a collapsible tubular sidewall housed within the frame, and a first filament formed into a first loop around the collapsible tubular sidewall, The first lever can include a first fulcrum. The second lever can include second fulcrum, the first filament can have a first intermediate portion extending away from the first loop and slidably extending around the first fulcrum, a second intermediate portion extending away from the first loop and slidably extending around the second fulcrum, a first tail portion extending from the first intermediate portion and connected to the frame, and a second tail portion extending from the second intermediate portion and connected to the frame. The collapsible tubular sidewall defining a valve lumen. The first lever and the second lever can be moveable between a first position in which the first filament and the second filament are tensioned to close the valve lumen by circumferentially constricting the first loop and the around the collapsible tubular sidewall and a second position in which the first filament and the second filament are loosened to least partially open the valve lumen.BRIEF DESCRIPTION OF THE DRAWI GS

[0037] Figure 1 is a schematic view of a fluid management system in accordance with one embodiment.

[0038] Figure 2 is a schematic view as in Figure 1 , with a clot attached to a grasping catheter which extends through a large diameter catheter.

[0039] Figure 3 is a schematic view as in Figure 2, with the clot drawn into a transparent viewing tube on the large diameter access catheter.

[0040] Figure 4 is a schematic view as in Figure 3, with the clot advancing towards a thrombus collection chamber.

[0041] Figure 5 is a schematic view as in Figure 4, with the clot deposited in a transparent thrombus collection chamber.

[0042] Figure 6 is a schematic view of a thrombectomy system configured to reinfuse filtered aspirated blood back into a patient.

[0043] Figure 7 A is a schematic view of an alternate configuration of the fluid management system.

[0044] Figure 7B is a schematic view of an alternate configuration of the fluid management system.

[0045] Figure 8 is a schematic view of a grasping catheter configured to apply suction to a clot.

[0046] Figure 9 is a schematic view of an alternative aspiration system having a first thrombectomy catheter and a second thrombectomy catheter extending therethrough.

[0047] Figure 10A is a schematic view of the hand piece for the first thrombectomy catheter of Figure 9.

[0048] Figures 10B - 10E illustrate interface details between a filter assembly and a handpiece.

[0049] Figure 11A is a schematic view of the handpiece for the second thrombectomy catheter of Figure 9.

[0050] Figure 11B is a simplified flow diagram of the dual vacuum chamber aspiration system.

[0051] Figure 11C is a qualitative fluid flow rate diagram at the catheter tip, following opening of the momentary vacuum control valve.

[0052] Figure 12 is a schematic flow diagram for a three-way valve.

[0053] Figures 13A-13C illustrate three flow configurations for a three-way valve.

[0054] Figures 14A- 14C illustrate operation of a hemostasis valve.

[0055] Figure 14D illustrates an alternative filament configuration of the hemostasis valve.

[0056] Figures 15A-15B are schematic layouts of the components of a proximal handle of an aspiration catheter.

[0057] Figure 16A and 16B are different implementations of thrombus engagement tools.

[0058] Figure 17A is a side elevational view of one thrombus engagement tool tip.

[0059] Figure 17B is a longitudinal cross-section through the tip of Figure 17A.

[0060] Figure 18A is a side elevational view of an alternative thrombus engagement tip.

[0061] Figure 18B is a longitudinal cross-section through the tip of Figure 18 A.

[0062] Figure 19A is a side elevational view of a catheter and split dilator system.

[0063] Figure 19B shows the system of Figure 19 A, with the dilator partially retracted and peeled away from the guide wire with the guide wire progressively escaping from the dilator through an axially extending split.

[0064] Figure 19 C shows the dilator fully retracted from the catheter but still over the guide wire.

[0065] Figure 19D shows the dilator fully removed from the catheter and the guide wire, leaving the catheter and guide wire unmoved from their position within the vasculature.

[0066] Figures 20A - 20C show a proximal handle for a dilator.

[0067] Figure 21 is a side elevational partial cross section of a catheter having a cannulated guide rail extending therethrough over a guidewire.

[0068] Figure 22 is a cross sectional view through a dual dilator system such as that shown in Figure 23.

[0069] Figure 23 is a side elevational cross section of a distal portion of a dual dilator system.

[0070] Figure 24 is a cross section as in Figure 23, with a distal tip formed by the tubular dilator.

[0071] Figure 25 is a side elevational view of a portion of a tubular dilator having a separation line to allow longitudinal splitting of the sidewall during proximal retraction.

[0072] Figure 26A is a perspective view of a hemostasis valve according to a modified configuration.

[0073] Figure 26B is a cutaway view of the hemostasis valve of Figure 26A.

[0074] Figure 27 is an exploded view of the hemostasis valve of Figure 26A.

[0075] Figure 28A is a cross-sectional view of the hemostasis valve of Figure 26A in a closed position.

[0076] Figure 28B is a cross-sectional view of the hemostasis valve of Figure 26A in an open position.

[0077] Figure 29A is a bottom perspective view of a looping pattern of a first filament and a second filament around a collapsible tubular sidewall.

[0078] Figure 29B is top view of the looping pattern depicted in Figure 29A.

[0079] Figure 29C is a front view of the looping pattern depicted in Figure 29A.

[0080] Figure 30 is a perspective view of a thrombectomy system.

[0081] Figure 31 is a longitudinal cross-section view of the thrombectomy system of Figure 30.

[0082] Figure 32A is transverse cross-section view of the thrombectomy system of Figure 30 with the hemostasis valve in a closed position.

[0083] Figure 32B is transverse cross-section view of the thrombectomy system of Figure 30 with the hemostasis valve in an open position.DETAILED DESCRIPTION

[0084] Referring to Figure 1, there is illustrated a fluid management system for large bore aspiration procedures. The system 10 includes a large diameter first thrombectomy catheter 12, having an elongate tubular body 14 extending between the proximal end 16 and a distal end 18. A central lumen 20 extends between a proximal catheter connector 22 and a distal port 24 on the distal end 18.

[0085] In the illustrated embodiment, the catheter 12 is releasably connectable to a flow control module 28 by way of a complementary module connector 30. Module connector 30 provides a releasable connection to complementary catheter connector 22, and may include an opener (not illustrated) for opening a hemostasis valve in the hub of the large bore catheter (not illustrated).

[0086] The flow control module 28 includes a fluid flow path 32 extending between the module connector 30 and the flow control module 28. The fluid flow path 32 continues to extend between the flow control module 28 and a reservoir 34, which contains a filter for thrombus collection and / or evaluation and a chamber for filtered fluid chamber (not illustrated). In an alternate implementation, the flow control module 28 is integrally formed within the hub of thrombectomy catheter 12 to which the catheter may be non-removably attached. In addition, the flow path between the flow control module 28 and the reservoir 34may be contained within a continuous integral tubing, or may be contained within two or more tubing components rclcasably connectable via complementary Lucr locks or other connectors.

[0087] Flow control module 28 may include a flow regulator for regulating flow through the flow path 32. The flow regulator is configured to provide a reversible restriction in the flow path, such as by an expandable or contractible iris, a ball valve or other rotary core valve, leaf valve, a pinch tubing, or others known in the art.

[0088] In one implementation, the flow regulator comprises a collapsible portion of the tubular wall defining the flow path, such as a section of polymeric tubing. An actuator positioned adjacent the tubing is movable between a first position where it compresses the tubing, thereby restricting flow to the low flow rate, and a second position where it has moved away from the tubing, allowing the tubing to resume its full inside diameter and allow the high flow rate. The actuator may be spring biased or have other default driver in the direction of the first (restricted) position, and only movable into the second position in the presence of an affirmative mechanical force or electrical signal that actuates the high flow override. Upon removal of the momentary override command, the actuator automatically resumes the first, position, producing the low flow mode.

[0089] The actuator may be driven by a mechanical control such as a lever or rotatable knob, or an electrically driven system such as a solenoid, operated by any of a variety of buttons, levers, triggers, foot pedals or other switches known in the ail, depending upon the desired functionality.

[0090] In another implementation, the fluid flow may be selectively directed through a low flow regulator such as a small diameter orifice or tube, and a high flow regulator such as a larger diameter orifice or tube. A mechanically actuated or electromechanically actuated valve can momentarily divert flow from the low flow to the high flow regulator in response to actuating a control.

[0091] Flow control module 28 thus includes one or more controls, for controlling the operation of the system. One control may be provided for toggling the system between a no flow (off) mode and a low flow mode. The same or a different control may be provided for momentarily toggling the flow regulator between the low flow mode and a momentary operator initiated high flow override mode. Release of the momentary override control causes the regulator to revert to off or low flow mode.

[0092] The low flow mode enables the first catheter 12 to approach and engage the clot with a relatively low volume of blood aspiration. Once the clot is engaged, the momentary high flow control may be activated to generate a bolus of high flow vacuum to draw the clot into the catheter 12. High flow may be at least about 10 cc / second, and preferably at least about 15 cc / sec but typically no more than about 25 cc / sec. In one construction the high flow rate is about 20 cc / sec, with all of the foregoing flow rates in an unobstructed aspiration of blood. Low flow as used herein is no more than about 50%, no more than about 35% or no more than about 25% of the high flow rate. Low flow is generally less than about 10 cc / sec or 7 cc / sec, and is often in the range of from about 1 - 5 cc / sec.

[0093] The flow control module 28 may be provided with a second catheter port 40 in communication with central lumen 20 via a hemostasis valve (e.g., Tuohy Borst valve)(not illustrated) within the module 28. This allows introduction of a second aspiration catheter 42 through the access catheter 12 and extending to the treatment site. The second catheter 42 may be a smaller diameter aspiration catheter, with or without clot agitation or mechanical grasping capabilities, drug delivery catheter, a mechanical disrupter or other accessory device that may be useful in the clot retrieval process. In one implementation, the second catheter including its hand piece and controls may be identical in material respects to the first aspiration catheter except the second catheter is smaller diameter and longer than the first catheter.

[0094] If desired, the second catheter 42 may be connected via a proximal connector 44 to a complementary connector 46 which is in communication with the reservoir 34 via aspiration line 48. Alternatively, aspiration line 48 may be connected to a separate aspiration and collection system (not illustrated).

[0095] The clot may be removable through the first catheter 12 under vacuum without additional assistance. However if desired, the secondary clot grasping catheter 42 may be introduced to provide additional attachment and I or mechanical disruption of the clot to facilitate removal. Removal may be assisted by the application of vacuum to the grasping catheter 42 as well as to the first catheter 12 in sequence or simultaneously depending upon the desired clinical performance.

[0096] Aspiration pump 50 may include a vacuum pump, and may also include a vacuum gauge 51, and an optional a pressure adjustment control 53. The vacuum gauge 51 isin fluid communication with the vacuum pump and indicates the vacuum pressure generated by the pump. The pressure adjustment control 53 allows the user to set to a specific vacuum pressure. Any of a variety of controls may be utilized, including switches, buttons, levers, rotatable knobs, and others which will be apparent to those of skill in the art in view of the disclosure herein. Aspiration pump 50 may alternatively be a manually activated pump such as a syringe.

[0097] Reservoir 34 is in fluid communication with the aspiration pump 50 via vacuum line 35 and acts to transfer vacuum from the air filled side of the system to the liquid side of the system, and also to collect aspirated blood and debris. Vacuum line 35 may be used as a flow restriction. Reservoir 34 thus includes a collection canister in fluid communication with flow path 32 and collects aspirated debris. The collection canister may include a filter that collects clot, which may be visually observed or accessed through a window to monitor progress of the procedure and I or used for pathologic diagnosis. The vacuum chamber and collection canister may be separate components that are in fluid communication with each other or merged within a single housing. The flow direction through the system may also be reversed to allow the blood to flow through the filter while the clot is collected outside (now downstream) of the filter, e.g. between the filter and the outer transparent window or container.

[0098] The flow path 32 extends throughout the length of the first catheter 12, through the control module 28 and into the reservoir 34. A transparent window 52 may be provided to enable direct visualization of the contents of the flow path 32. In the illustrated embodiment, the window 52 is in the form of a transparent section of tubing between the proximal end of the access catheter 12 and the flow module 28, and within the sterile field so that the clinician can directly visualize debris as it exits the proximal end of the access catheter 12 and before it reaches the reservoir 34 which may be outside of the sterile field. The actual length of the transparent tubing is preferably at least about two or four or 6 cm long and generally less than about 30 or 20 cm long. In some implementations, the length of the transparent tube is within the range of about 5 cm to about 15 cm. In an alternate implementation, the transparent window may be carried by the proximal hub of the access catheter 12, or may be a proximal portion of the catheter shaft, distally of the hub.

[0099] Referring to Figure 2, the secondary catheter is in the form of a second aspiration catheter 42 which has been distally advanced through the access catheter 12 andthrough the vasculature into proximity with a clot 60. The clot 60 may be grasped by the second catheter 42 in any of a variety of ways such as by mechanical attachment or suction, or both.

[0100] Referring to Figure 3, the second catheter 42 has been partially proximally retracted, drawing the clot 60 into the first catheter 12 such that the clot 60 becomes visible through the window 52. This may be facilitated by applying vacuum through both the grasping catheter 42 and the access catheter 12.

[0101] Continued proximal retraction of the grasping catheter 42 brings an interface 62 between the grasping catheter 42 and the clot 60 into view through the window 52. This enables the clinician to visually confirm that a clot has been captured.

[0102] Referring to Figure 4, further proximal retraction of the grasping catheter 42 allows the clot 60 to be drawn through the flow path 32 in the direction of the reservoir 34. The clot 60 is there after drawn by vacuum into the collection chamber within reservoir 34, where it may be captured by a filter and viewed through a transparent sidewall or window 37 on the collection chamber.

[0103] Another aspect of fluid management during the thrombectomy procedure is illustrated in Figure 6. In this implementation, an aspiration line 64 places the first catheter 12 in communication with a thrombus filter 66. The thrombus filter 66 is further in communication with a pump such as a syringe aspiration pump 50 by way of aspiration line 68. Actuation of the pump 50, such as by proximally retracting the plunger, draws thrombus through the access catheter 12 and into the thrombus filter 66 where thrombus and thrombus particles having a size greater than a predetermined threshold will be entrapped. The thrombus filter 66 may be provided with a transparent window for a visual confirmation, as has been discussed.

[0104] Blood drawn into the syringe 50 will therefore be filtered, with the debris remaining in the thrombus filter 66. Blood in the pump 50 or other reservoir downstream from the filter may be re-infused into the patient. In the illustrated configuration this may be accomplished by reversing the pump (pushing the plunger) and pushing filtered blood via a bypass tube 70 which merges with the flow path 32 on the patient side of the filter 66 and back into the patient. In some cases, the blood in the pump 50 or other reservoir downstream from the filter 66 may be re-infused into the patient via an introducer sheath and / or through a multiport, such as the multiport 618, which is described in relation to Figure 26 and Figures 27A and 27B. A valve assembly 74 is preferably provided to direct thrombus containing bloodfrom the patient into the filter 66 hut ensure that only filtered hlood can be pumped through bypass 70 and back into communication with the flow path 32 and into the patient.

[0105] In the illustrated implementation, the valve assembly 74 comprises a first valve 72 in the bypass tube 70 which permits flow of filtered blood in the direction of the patient but blocks the flow of unfiltered blood through the bypass tube 70 in the direction of the pump 50. The second valve 76 is provided to permit flow of unfiltered blood in the direction of the filter 66 but prevent the flow of blood from the filter back in the direction of the patient. In one execution of the implementation, the first valve 72 and second valve 76 are one way flapper valves that open or close in response to blood flow direction.

[0106] A further configuration of the fluid management system is schematically illustrated in Figure 7A. Aspiration line 64 places the first aspiration catheter 12 in communication with the thrombus filter 66. The thrombus filter 66 is in communication with the aspiration pump 50 by way of aspiration line 68. Aspiration line 68 includes a flow control 76. Flow control 76 includes an off I on control such as a switch 78. Activation of the switch 78 to the ‘on’ configuration places the system in a low flow vacuum mode as has been discussed. Activation of a momentary full flow control such as a button 80 changes the system to the high flow mode.

[0107] In an alternate configuration illustrated in Figure 7B, the flow control 76 is moved from between the aspiration pump 50 and thrombus filter 66 to in between the catheter and the thrombus filter 66. This allows the negative pressure in the chamber of thrombus filter 66 to reach equilibrium with the canister in the aspiration pump 50 when the valve in flow control 76 is closed. When the valve is subsequently opened, the relatively short distance between the thrombus filter and the patient allows a rapid drop in negative pressure at the distal end of the catheter as is discussed in greater detail in connection with Figure 11B. The flow control 76 my additionally be provided with an optional vent to atmosphere, or to no vacuum, or vent to a source of vacuum at a milder vacuum than that experienced in the cannister of the aspiration pump 50.

[0108] Figure 8 illustrates a second, smaller aspiration catheter 42 such as a 16 French catheter, configured for the application of suction to facilitate grasping a clot. In a typical configuration, the second catheter 42 will be extended through a first, larger catheter 12 (not illustrated) as has been discussed. As with any of the second catheters disclosed herein, a mechanical agitator 82 may be axially movably positioned within a central lumen of the grasping catheter 42. Sec also Figures 16A-18B. Additional details of one suitable mechanical agitator 82 are disclosed in US Patent No. 10,653,434 to Yang, et al., entitled Devices and Methods for Removing Obstructive Material from an Intravascular Site, the entirety of which is hereby expressly incorporated herein by reference. Additional details of the mechanical agitator 82 are disclosed in US patent application serial No. 15 / 443,874, filed 2 / 27 / 2017, entitled Telescoping Neurovascular Catheter with Enlargeable Distal Opening, and US patent application serial No. 16 / 398,626, filed 4 / 30 / 2019, entitled Devices for Removing Obstructive Material from an Intravascular Site, the entireties of which are hereby expressly incorporated herein by reference.

[0109] Referring to Figures 9 and 10 A, there is illustrated a further implementation of an aspiration system 100. The system includes a first thrombectomy catheter 102, such as a large bore aspiration catheter, and a second aspiration catheter 104 which is optionally advanceable through the first thrombectomy catheter 102 as has been discussed, or used by itself.

[0110] Thrombectomy catheter 102 comprises a proximal handle 106 having an elongate flexible tubular catheter body 108 extending distally therefrom. The proximal end 110 of the tubular body 108 may be permanently carried by the proximal handle 106 or may be provided with a releasable connector for detachable connection to a complementary connector on the handle 106.

[0111] In one implementation, the tubular body 108 or 152 or both are provided with a flexible neck 109 extending between proximal end 110 and a transition 111. The flexible neck 109 has a greater flexibility than the adjacent portion of the tubular body 108 distal to the transition 111. The flexible neck 109 may have a length of at least about 2 cm and often at least about 4 cm, but generally no more than about 20 cm or 10 cm or less.

[0112] The sidewall of the catheter body 108 within flexible neck 109 includes a helical coil 113 having adjacent filars spaced apart to both improve flexibility, and also allow visualization between adjacent windings of the coil. At least the flexible neck 109 includes a sidewall window such as the spaces between adjacent coil windings which may be in the form of an optically transparent outer tubular layer, such as any of a variety of optically transparent shrink tubing polymers. This allows visualization of clot through the side wall as it passesthrough the neck 109 before it enters the proximal handle. The transparent window on the larger catheter 108 also allows visualization of the distal tip of the inner catheter 152 as it passes the window. This may be facilitated by placing a visual marker on the distal end of the inner catheter 152 such as a colored annular band.

[0113] For example, in an implementation having a 24 French tubular body 108, the smaller tubular body 152 (e.g. 16 French catheter) may be provided with a visual indicium such as a white tip on the distal end, that can be visualized through the sidewall window as it passes through the flexible neck 109. The flexible neck 109 may also be provided on the catheter shaft 152.

[0114] The spring coil 113 may extend distally to a point of termination within about one or 2 cm of the transition 111, and, and one implementation, at the transition 111. Distally of the transition, the sidewall of tubular body 108 may include a tubular braid, importing greater stiffness and higher push ability than the helical coil 113.

[0115] The proximal end of the catheter may be provided with a rotation control such as a rotatable knob 115 which may be rotationally fixed to the catheter and rotatable with respect to the handle housing. This facilitates relative rotation between the catheter and the housing for any of the large or small bore catheters disclosed herein.

[0116] A central lumen extending through the tubular catheter body 108 is in communication with a flow path extending through the proximal handle 106 to a proximal access port 112. The flow path between the tubular catheter body 108 and the proximal access port 112 is preferably linear, to axially movably receive the second catheter 104 which may or may not be utilized in a given procedure. To accommodate the absence of second catheter 104 and seal the port 112, the proximal handle 106 is preferably provided with a hemostasis valve 114 such as a Thuohy-Borst valve.

[0117] A manifold switch 116 controls two way or three way a manifold valve (illustrated in Figure 12) for selectively controlling fluid flow as discussed further below. An aspiration control 117 is provided to turn aspiration on and off. Alternatively, manifold switch 116 can be configured to turn aspiration one and off.

[0118] A filter assembly 120 includes housing 122 with a side wall 124, at least a portion of which includes a transparent window 126. Window 126 permits a viewing of the contents (e.g. aspirated clot) of a filter chamber 128, which contains a filter 130.

[0119] The filter assembly 120 is configured to place the filter 130 in the flow path between the tubular catheter body 108 and the aspiration tubing 118. Preferably the filter chamber can be closed to maintain negative pressure conveyed from a pump via aspiration tubing 118, or opened to permit insertion or removal of the filter 130. In the illustrated implementation, the filter assembly 120 is removably connected to the handle 106. A connector 134 such as a first thread on the housing 122 is releasably engageable with a complementary connector 136 such as a complementary thread on the handle 106. A vent (aperture) to atmosphere may be provided in communication with the filter chamber, to reduce foaming of blood in response to reduced pressure.

[0120] The present implementation includes an integrated flow control module in the proximal handle 106. Thus, an adjustable flow regulator (not illustrated) may be positioned in the flow path, to enable controllable toggling of the aspiration between a low flow mode and a high flow mode. In the illustrated implementation, optional flow regulator is positioned downstream of the filter 130, and contained within the housing 122 of the filter assembly 120. A flow regulator control 132 is provided, to control the flow rate. Preferably, as has been discussed, the flow regulator is configured to regulate fluid flow through the flow path at a default low flow rate. Activation of the flow control 132 adjust the flow to the high flow rate mode. Flow control 132 may be a momentary button, slider switch, trigger, knob or other structure that is preferably defaulted to the low flow mode.

[0121] In any of the catheters disclosed herein, carrying the filter chamber 128 on the catheter or at least spaced apart from the remote vacuum pump and vacuum cannister provides enhanced aspiration performance. The location of a conventional aspiration pump may be far enough away from the patient to require a length of aspiration tubing between the pump and the catheter to be as much as 50 inches or 100 inches or more. The pump typically includes an aspiration canister for blood collection. When aspiration is desired, a valve is opened to place the low pressure cannister in communication with the catheter by way of the aspiration tubing, to aspirate material from the patient. But the length of the aspiration tubing operates as a flow restrictor, causing a delay between the time of activating the vacuum button and actual application of suction to the clot.

[0122] In some embodiments, the catheter handle 106 or 140 contains a filter chamber 128 for example, which is in communication with the vacuum cannister on the pumpby way of elongate aspiration tubing 118. The momentary aspiration control 117 is in between the filter chamber 128 and the catheter, which, in the default off position, allows the entire length of the aspiration tubing 118 and the filter chamber 128 to reach the same low pressure as the aspiration cannister on the pump. The flow restriction between the pump cannister 129 and the filter chamber 128 is greater than the flow restriction between the filter chamber 128 and the patient.

[0123] In an alternate configurations, 117 may be a vent to atmosphere which allows the clot canister to be evacuated. Element 142 can alternatively be an injection port such as for injecting contrast media, saline, or drugs.

[0124] Thus, the only remaining flow restrictor between a source of vacuum (filter chamber 128) and the patient is the relatively short aspiration pathway between the valve in the handpiece and the distal end of the catheter. When the momentary aspiration control 117 is activated, the flow restriction and enclosed volume on the patient side of the filter chamber is low relative to the flow restriction and enclosed volume through aspiration tubing 118 on the pump side of the filter chamber 128.

[0125] This dual chamber configuration produces a rapid spike in negative pressure experienced at the distal end of the catheter upon activation of the aspiration control 117. The response time between activating the aspiration control 117 and realizing suction actually experienced at the clot is significantly faster and allows significantly higher initial flow than the response time realized in a conventional system having only a vacuum chamber located at the pump.

[0126] The spike of negative pressure experienced at the distal end of the catheter will fade as pressure equilibrium is reached between the filter chamber and canister. When the momentary aspiration control 117 is closed, the vacuum pump will gradually bring the pressure in the filter chamber 128 back down to the level in the vacuum cannister at the pump.

[0127] A simplified fluid flow diagram is illustrated in Figure 11B, and a qualitative flow rate diagram is illustrated in Figure 11C. The flow restriction between chamber 128 and the distal and 107 of catheter 108 is small relative to the flow restriction between the vacuum canister 129 and the vacuum chamber 128. This allows a negative pressure peak experienced at distal end 107 almost instantaneously upon activation of vacuum switch 117. The flow rate of material into the catheter 108 rapidly reaches a peak and subsides as vacuumchamber 1 8 fills with aspirated material. The vacuum in chamber 128 declines to a minimum, and slowly recharges by the large vacuum chamber 129 and associated pump through tubing 118. In use, a clinician may choose to allow the momentary vacuum switch 117 to close at or shortly following the maximum flow rate, just giving a short burst or spike of vacuum to facilitate spiration of thrombus into the catheter 108.

[0128] Additional details of the filter assembly and related structures are illustrated in Figures 10B to 10E. Referring to Figure 10B, the filter assembly 120 includes a tubular sidewall 124 having a transparent window 126. In some implementations the entire tubular sidewall 124 can be a transparent window. The side wall 124 encloses a filter 130 as has been discussed. The filter 130 includes a tubular filter side wall 320 defining an interior chamber 321 for filtered blood. Filtered blood is drawn in the direction of vacuum line 210 through a first vacuum aperture 322 and into a flow path 324 having a vertical offset 326 in the flow path 324. The vertical offset 326 allows removal of blood from the bottom of the chamber, through a flow path and out through a second vacuum aperture more centralized with respect to a central axis of the tubular sidewall 124 and in communication with vacuum line 210.

[0129] The filter 130 is displaced downward with respect to a central longitudinal axis of the tubular sidewall 124, leaving the filter chamber 128 having a chamber height 129 at least as great as the inside diameter of a filter line aperture 330 leading to filter line 208. This allows clot to move from filter line 208 into the filter chamber 128 without restriction, and optimizes the volume of filter chamber 128 on top of the filter 130 for viewing through the window 126.

[0130] A connector 134 maybe carried by the filter assembly 120, such as in the form of a bayonet mount, or other releasable attachment to the handpiece housing. A first seal 332 such as an annular elastomeric ring may be provided between the tubular sidewall 124 and the complementary surface on the handpiece housing.

[0131] A second vacuum aperture 328 is in communication with the first vacuum aperture 322 by way of the flow path 324. Second vacuum aperture 328 may be carried on an axially extending tubular projection 336 which may be removably received within a complementary recess on the hand piece housing.

[0132] A second seal 340 such as an elastomeric ring maybe provided surrounding the flow path 324, for providing a seal between the filter assembly and the handpiece. In theillustrated implementation, the second seal 340 surrounds the tubular projection 336 and is configured to seal against an adjacent complementary surface on the handpiece in the as mounted orientation.

[0133] Referring to Figure 10D, the filter assembly 120 additionally includes a filter base 342 through which filter line aperture 330 extends. The flow path 324 additionally extends through the filter base 342, and, in the illustrated implementation, exits the tubular projection 336 carrying the second vacuum aperture 328.

[0134] A complementary docking platform 350 is carried by the handpiece, having complementary connector to connector 134 for rapid attachment and detachment of the filter assembly 120 from the handpiece. In the illustrated embodiment, at least a first flange 352 maty be received through an opening 354 on the filter assembly 120. Rotation of the filter assembly 120 moves the first flange into interference fit with a second flange 356 to secure the filter assembly 120 to the docking platform 350 on the handpiece. Two or three or four or more similar flange and complementary opening pairs may be provided around the periphery of the components. In the illustrated implementation, the circumferential arc length of the flange and corresponding opening on one of the three pairs is greater than the other two pairs to function as a key, so that the filter assembly can only be secured to the docking platform in a single rotational orientation.

[0135] The docking platform 350 includes a filter line aperture 360 for communicating with filter line 208, and a vacuum line aperture 362 for placing the filter 130 in communication with a source of vacuum. The docking platform 350 may be connected to a two way valve 362 or a three way valve as is discussed elsewhere herein depending upon the desired functionality. The valve may carry a rotatable drive gear 304 to rotate the interior rotatable valve gate as is discussed in additional detail below. Alternatively, a lever or other control on the housing may be configured to rotate a shaft directly coupled to the rotatable part of the valve.

[0136] A valved flow path may also be provided for venting the filter chamber 128 directly to atmosphere. The valve may be opened such as by depressing a momentary button, which is biased in the closed direction. This can create an abrupt change in pressure at the distal end of the catheter, which may facilitate clot aspiration. This can also be used to discharge vacuum

[0137] Referring to Figure 1 1 A, additional details of the handle 140 of the second catheter 104 arc disclosed. The handle 140 extends between a proximal end and a distal end. An elongate flexible tubular body 152 extends distally from the distal end of the handle 140 and is configured to advance distally through the proximal handle 106 and the tubular body 108 of thrombectomy catheter 102.

[0138] A steering dial 144 may be provided to place one or more steering wires under tension, to deflect a deflection zone near the distal end of the tubular body 152. A manifold switch 116 may be provided to control the flow of fluid as will be discussed below. The handle additionally comprises an aspiration control 117 such as a slider switch, for turning aspiration on or off. A max button 132 may be provided for delivering a momentary pulse of high aspiration rate as has been discussed.

[0139] Fluid flow through the thrombectomy system is controlled by manifold switch 116 (see, e.g., Figure 9), which may control a two way or three-way valve. Referring to Figure 12, a schematic flow diagram for three-way valve 200 is provided. Patient line 202 can be placed in fluid communication with the patient, via a catheter such as a large diameter thrombectomy catheter 12 or second catheter 42.

[0140] Patient line 202 may be placed in communication with a manifold line 204 by advancing the three-way valve 200 to a first position, such as to allow delivery of medications, contrast media or saline to the patient.

[0141] Adjustment of the three-way valve 200 to a second position can isolate patient line 202 and place the manifold in communication with the filter 206 via filter line 208. Activation of a vacuum pump will draw blood from the patient and through the filter 206 via vacuum line 210.

[0142] Further adjustment of the three-way valve 200 to a third position will place the manifold in communication with the vacuum line 210, such as to permit a saline flush of the filter 206. This third position may be eliminated depending upon the desired functionality.

[0143] One implementation of a suitable three-way valve 200 is illustrated in Figures 13A through 13C. Referring to Figure 13A, the valve 200 may comprise a housing 220 such as a cylindrical housing having a central cavity 221. A rotatable cylindrical gate 222 may be positioned in the central cavity 221, as illustrated in the exploded view of Figure 13 A. Rotatable gate 222 is provided with a flow path 224 extending between a first end 226 and asecond end 228. In the illustrated implementation, the first end 226 and a second end 228 of the flow path arc spaced apart around the circumference of the rotatable gate by approximately 120 degrees.

[0144] In the rotational orientation of the rotatable gate 222 illustrated in Figure 13 A, the first end 226 of the flow path 224 is in communication with a first port 232, and the second end 228 of the flow path 224 is in communication with a second port 234. This corresponds to the first position discussed previously, in which the patient is in fluid communication with the manifold.

[0145] Figure 13B illustrates rotatable gate 222 in the second position where the flow path 224 places the first port 232 in communication with the third port 230 to place the filter 206 in communication with the manifold. The rotatable gate 222 may be toleranced within the cavity 221 such that the rotatable gate 222 seals the second port 234 thus isolating the patient from the flow path in this orientation. Similarly, in each of the other two orientations, two of the ports are placed in communication with the flow path, while the third port is isolated from the flow path.

[0146] The third position is illustrated in Figure 13C, in which the flow path places the second port 234 in communication with the third port 230, placing the filter 206 in communication with the patient, and isolating the manifold from the flow circuit.

[0147] The foregoing selectivity may be achieved by spacing the three ports approximately 120 degrees apart around the circumference of the housing, to cooperate with the flow channel 224 end ports which are about 120 degrees apart around the circumference of the cylindrical gate 222. The gate 222 may be rotated within the housing 220 by a connector 236 extending through the housing 220 such as along the axis of rotation, and connected to a control 116 such as a rotatable knob, lever or slider switch with a rack and pinion drive assembly.

[0148] Each of the catheters disclose herein may be provided with a hemostasis valve on the proximal end, to allow selective closing of the central lumen to completely closed without any devices extending therethrough, from a sealed fit around devices of differing diameters such as a guide wire or a secondary catheter extending therethrough. One example of a suitable hemostasis valve is schematically illustrated in Figures 14A through 14C.

[0149] Referring to Figure 14A, hemostasis valve 250 includes a frame 252 for supporting a flow path defined within a tubular sidewall 254. The frame 252 may be integrally formed with or mounted to the catheter handle or hub.

[0150] The flow path and tubular sidewall 254 extend between a first end 256 and a second end 258. First end 256 may be a port 112 (see, e.g., Figure 9) on the proximal end of any of the catheters disclosed herein. Second end 258 may be in communication with the central lumen of the corresponding aspiration catheter, such that devices entering the first end 256 and advanced axially through the flow path can advance all the way to the distal end of the aspiration catheter and beyond.

[0151] At least a portion 260 of the sidewall 254 is collapsible in response to external pressure. That portion 260 and optionally the full length of the tubular sidewall within valve 250 may be comprise a collapsible elastic tube such as silicone tubing, which is biased into an open lumen tubular configuration when unconstrained. A compression element such as filament 262 is configured to apply compressive force against the sidewall 254 to reduce the inside diameter of the flow path to provide a seal against itself (when completely closed with no devices extending therethrough) or against a device such as a guidewire or catheter extending therethrough. In the illustrated implementation, the filament 262 forms a loop 268 around the collapsible portion 260 of tubular sidewall 254. Retraction of a first tail portion 270 of the filament 262 away from the sidewall 254 constricts the diameter of the loop 268 thereby collapsing the portion 260 of the tubular sidewall as illustrated in Figure 14 A.

[0152] In the illustrated implementation, the first tail portion 270 of the filament 262 may be retracted by at least a first lever 264. Lever 264 may be connected to the frame 252 by a first pivot 266 and is attached to the tail portion 270 at an attachment point 272. Advance of the lever in a first direction places the filament under tension and reduces the inside diameter of the valve. Releasing the lever removes the tension and the collapsible portion 260 of the sidewall rebounds to its unconstrained, open lumen configuration.

[0153] In the illustrated implementation, a second lever 274 is attached to the frame 252 at a second pivot 276, and is attached to a second tail portion 278 of the filament 262. Each of the first and second tail portions may comprise a single filament or two or three or more parallel filaments. In the two filament configuration as illustrated, the filaments may be immovably secured to the lever, or may be a continuous filament, looped around a fulcrum280. The loop 268 may comprise one or two or three or more revolutions around the tubular sidewall, depending upon the desired performance.

[0154] At least one lever 264 is provided with a spring 282 to bias the lever away from the tubular sidewall, constricting the inside diameter of the collapsible portion 260 into sealing engagement with a device extending therethrough, or to a completely closed configuration in the absence of a device. As illustrated, a second lever 274 may also be biased using the same spring or a second spring.

[0155] As illustrated in Figure 14C, compression of the levers in a medial direction towards the axis of the tubular sidewall 254 releases tension on the tail portions of the filament and allows the valve to open, such as to permit advance of a catheter through the valve. Releasing the levers allows the spring bias to retract the tail portions, reducing the diameter of the loop 268 and collapsing the collapsible portion 260 into sealing engagement with the outside surface of the secondary catheter, at an intermediate valve diameter as seen in Figure 14B.

[0156] Retraction of the tail portion 270 of filament 262 may alternatively be accomplished by winding the tail portion 270 around a rotatable spool such as a shaft or drum. Rotation of a knob or advance of a lever causes the spool to take up filament and collapse the sidewall.

[0157] An alternate configuration for the filament 262 is illustrated in Figure 14 D. In this implementation, the first tail portion 270 slidably extends around a first fulcrum at 272 and returns to attach to the housing at an attachment point 271. First tail portion 270 extends from the fulcrum to form a loop 268 around the collapsible tube. The filament 262 may make a single revolution or two or more revolutions around the collapsible tube before continuing on around a second fulcrum at 280, to a second point of attachment 279 to the housing.

[0158] Compression of the first lever 264 and second lever 274 loosens the loop 268, allowing the lumen to resume patency. Releasing the levers allows the spring bias to reduce the diameter of the loop 268 as the first tail portion 270 and second tail portion 278 slide away from each other around the left and right fulcrums. Preferably, friction between the filament 262 and fulcrums are minimized, as by providing a lubricious oil such as silicone oil around the fulcrums at 280 and 272, as well as using Teflon braided line for the filament 262.

[0159] Various components of the aspiration system handle are schematically represented in context in Figure 15A. The proximal handle 140 on a second catheter 104 includes a filter 206, a tubular body 152 and other features previously described. Two-way or three-way valve 200 selectively controls flow among the filter line 208, patient line 202 and manifold line 204. In this implementation, the three-way valve control 116 is in the form of the slider switch. The slider switch axially movably displaces a first linear rack gear 300. Rack gear 300 engages a pinion gear 302, which may either directly rotate the gate in the valve 200, or, as illustrated, drive a third gear 304 which rotates the rotatable gate within 200. An alternative valve control system is schematically illustrated in Figure 15 B. In this implementation, the slider switch, linear rack gear 300 and pinion gear 302 omitted. A valve control 116 in the form of a lever 117 is attached directly to a shaft which controls rotation of the valve gate. The lever may be advanced proximally or distally, to adjust the flow path through the valve as has been discussed.

[0160] A steering mechanism 306 is provided to permit steering of the second catheter 152. Manually rotatable knob 148 allows manual rotation of a core wire and distal helical tip as has been discussed. The core wire axially movably extends across hemostasis valve 146. Alternatively, the core wire and tip (e.g., thrombus engagement tool 400) may be coupled to a motorized drive unit at the proximal end of the catheter system.

[0161] In certain implementations, an aspiration catheter such as a 16 French catheter is advanced transvascularly over a wire and / or through a larger diameter (e.g., 24 French aspiration catheter) to the treatment site. If the application of vacuum is not able to aspirate the clot into the 16 French catheter, an elongate flexible thrombus engagement tool may be advanced through the 16 French aspiration catheter, to facilitate retrieval of the clot.

[0162] Referring to Figures 16A and 16B, the thrombus engagement tool 400 may comprise an elongate flexible shaft 402 having a proximal end 404 and a distal end 406. A proximal hand piece such as a handle 408 may be configured to be rotated by hand. Distal end 406 carries a clot engagement tip 410 which may include one or more radially outwardly extending structures such as a helical thread 412. The handle 408 may have an indicium of rotational direction such as a printed or molded arrow 109 which indicates the direction to rotate the handle 408 in order for the helical thread 412 to engage clot.

[0163] In one implementation illustrated in Figure 16B, the thrombus engagement tool 400 carries a clot engagement tip 410 of the type illustrated in Figures 18A and 18B. The proximal end of the tip 410 is glued to the distal end of a braid-reinforced polyimide tube. The proximal end of the Microlumen has a cannulated torquing handle 408, and the whole assembly is cannulated so it can be delivered and function over a wire 468 such as an 0.035” wire. The 0.035” wire helps maintain space between the tip and the vessel wall, and the wire can be pulled back inside the working length of the flexible shaft 402 during rotation and engagement with the clot as needed.

[0164] Referring to Figure 17A, the distal tip 410 includes a helical thread 412 extending from a distal end 414 to a proximal end 416 and supported by flexible shaft 402. The axial length of the distal tip 410 is at least about 2 mm or 5 mm or 10 mm and in some embodiments no more than about 30 mm or 20 mm measured along the flexible shaft 402. The helical thread 412 wraps around the axis at least about 1 or 2 or 4 or more full revolutions, but in some embodiments no more than about 10 or 6 revolutions. In some embodiments the axial length along the threaded portion of the tip is within the range of from about 1 to about 8 revolutions.

[0165] The helical thread 412 on this implementation may have a constant pitch throughout its length. The pitch may be within the range of from about 10 to about 20 threads per inch, or about 5 to about 10 threads per inch depending upon desired performance. Alternatively, the thread may have multiple pitches designed to engage, transport and grasp thrombus within the catheter lumen. A distal pitch may be less than a proximal pitch. The pitch may vary continuously along the length of the thread, or may step from a first, constant pitch in a proximal zone to a second, different pitch in a distal zone of the thread. The thread 412 may comprise a continuous single helical flange, or may have a plurality of discontinuities to produce a plurality of teeth or serrations, arranged helically around the core wire.

[0166] The side elevational profile or envelope scribed by the distal tip as it rotates may have a linear or nonlinear taper on one or both ends (e.g., football shaped) which provide varying diameter and thus clearance along its length from the generally cylindrical ID of the catheter lumen.

[0167] The maximum OD of the thread 412 is preferably smaller than the diameter of a sliding fit within the catheter lumen, and may generally be at least about 0.015 inches or 0.010 inches smaller than the catheter lumen ID. In some implementations, the Max OD of the tip may be significantly less than the inside diameter of the catheter lumen to allow more space for the thrombus, but still create significant grasping force via engagement of the helical threads with the thrombus. In one implementation, the maximum helical thread diameter is about 0.110 inches and the catheter lumen ID is about 0.275 inches (24F) (a 0.165 inch gap between the helical threads and catheter wall.

[0168] In certain applications, the Max OD of the tip is no more than about 35% or no more than about 40% or no more than about 60 % of the ID of the catheter, to leave a substantial tip bypass flow path. Since this implementation does not have any centering structures for the tip 410 or shaft 402, the tip will normally be pushed to one side of the aspiration lumen. When a clot becomes lodged between the tip and the opposing wall of the catheter, manual rotation of the tip can engage the clot like a worm gear and either grasp the clot (e.g., by pinning it against the opposing catheter sidewall) for retraction or facilitate freeing the blockage and aid in ingestion of the clot into the catheter.

[0169] The profile of the tip 410 viewed along the axis of rotation may be circular, or may vary to create a non circular pattern around the axis of rotation. The tip as seen in an end elevational view thus exhibits a major diameter and a minor diameter. The minor diameter may be no more than about 95% or 90% or 80% or 70% of the major diameter, depending upon desired performance.

[0170] Referring to Figures 17A and 17B, the illustrated tip 410 includes a distal advance segment 418 extending between an atraumatic distal tip at 420 and a transition to the distal end 416 of the thread 412. Helical thread 412 extends proximally from the transition to a proximal end 414 of the helical thread 412. A trailing segment 422 extends between the proximal end 414 of the thread and the proximal end 424 of the tip.

[0171] The axial length of the advance segment 418 may be at least about 1 cm or 2 cm and in some implementations is within the range of from about 2 cm to about 4 cm. The axial length of the helical thread 412 along the longitudinal axis is typically within the range of from about 1 cm to about 5 cm and in certain implementations between about 2 cm and 3 cm.

[0172] The outside diameter of the advance segment 418 at distal tip 420 is generally less than about 0.024 inches, or less than about 0.020 inches and, in one implementation, is about 0.018 inches. The maximum outside diameter of the advance segment 418 and helical thread 412 may be within the range from about 0.020 to about 0.045 inches, and, in one implementation, is less than about 0.040 inches, such as about 0.035 inches. The advance segment, helical thread and trailing segment of the tip 410 may be molded over the flexible shaft 402 using any of a variety of polymers known in the catheter arts.

[0173] Referring to Figure 17B, a first radiopaque marker 430 may be carried on the flexible shaft 402 beneath the advance segment 418. A second radiopaque marker 432 may be carried on the flexible shaft 402 within the trailing segment 422. Each radiopaque marker may comprise a radiopaque tube or a coil of radiopaque wire such as a platinum iridium alloy wire having a diameter about 0.002 inches, and wrapped around the flexible shaft 402 and soldered to the flexible shaft 402 to produce an RO coil having an outside coil diameter of less than about 0.020 inches, such as about 0.012 inches. The radiopaque markers may also function as an axial interference fit between the flexible shaft 402 and the molded advance segment 418 and trailing segment 422 to resist core wire pull out from the tip 410.

[0174] In one implementation, the maximum OD of the thread 412 exceeds the maximum OD of the advance segment 418 by at least about 15% or 25% or 30% or more of the OD of the advance segment 418, to facilitate crossing the clot with the advance segment 418 and engaging the clot with the thread 412. The thread pitch may be within the range of from about 0.75 to about 0.30, or within the range of from about 0.10 and about 0.20, such as about 0.14 inches.

[0175] Preferably, the maximum OD of the tip 410 is less than about 60% or less than about 40% of the aspiration catheter ID at the distal end of the catheter, and may be within the range of from about 35% to about 55% of the catheter ID. In certain implementations, the maximum OD of the tip 410 may be within the range of from about 0.044 inches to about 0.041 inches within a catheter having a distal end ID within the range from about 0.068 inches to about 0.073 inches.

[0176] Depending upon the clinical application, it may be desirable to control the extent to which, if any, the distal tip 410 can extend beyond the distal end of the catheter. For example, distal extension of the distal end of the helical tip beyond the distal end of the cathetermay be limited in some implementations to no more than about 5 mm or 3 mm or 1 .5 mm or 1.0 mm or less. In other clinical environments the distal tip 420 may be permitted to extend at least about 2 cm or 3 cm and preferably as much as 4 to 8 cm beyond the catheter, but generally will be limited to extend no more than a preset distance such as 12 cm or 8 cm or 5 cm beyond the catheter depending upon desired performance. In one implementation, distal advance of the tip 410 is limited so that the distal end is within 2 cm or within 1 cm or no more than 0.5 cm in either the distal or proximal direction from the distal end of the aspiration catheter.

[0177] Distal advance of the tip 420 may be limited by providing mechanical interference at the desired distal limit of travel. In one implementation, a distal stop surface 440 on the handle 408 provides an interference engagement with a complementary proximal surface carried by the aspiration catheter through which the thrombus engagement tool 400 is advanced. Alternatively, a distal engagement surface can be carried anywhere along the length of the thrombus engagement tool 400, for sliding engagement with a complementary proximally facing stop surface carried by the catheter. Additional details may be found in US patent application serial No. 17 / 036,258 filed September 29, 2020 and entitled Embolic Retrieval Catheter, which is hereby expressly incorporated in its entirety herein by reference.

[0178] The limit on distal advance of the helical tip may include a first configuration in which distal advance is limited to a first position proximate the distal end of the evacuation catheter to prevent injury to the vascular wall. Upon a user initiated adjustment, the helical tip may be advanced to a second position farther out of the distal end of the catheter such as for inspection and cleaning purposes. This adjustment of the limiting mechanism may be locked out following cleaning or inspection, to limit distal travel to the first position to prevent an undesired degree of exposure of the helical tip element when the system is within the patient’s vasculature. Any of a variety of movable interference levers of pins may be engaged to limit travel to the first position, or disengaged to allow travel to the second position.

[0179] Referring to Figures 18A and 18B, a tip 410 includes a tubular sidewall 440 defining a hub having a connector such as a cavity 442 for coaxially receiving the distal end of a support shaft such as a braid reinforced polyamide tube. The inside diameter of the cavity 442 steps down at a distal end of the hub at a step 444 to a smaller diameter lumen 446 in communication with a distal opening 448. This provides a continuous lumen throughout thelength of the micro lumen shaft and tip 410 so that the thrombus engagement tool can be introduced over the wire.

[0180] In general, the pitch of thread 412 may be within the range of from about 0.07 to about 0.11, and in one embodiment, is about 0.09. The width of the thread 412 measured along an axis that is perpendicular to a face of the thread may be within the range of from about 0.009 to about 0.04, and, in one embodiment, is about 0.02. The greatest major diameter of the thread 412 may be at least about 10%, or at least about 15%, or at least about 20% greater than the diameter of the proximal hub end of the tip 410 surro unding the cavity 442. In one implementation, the outside diameter of the proximal hub is about 0.090 inches and the outside diameter of the thread 412 is about 0.110 inches. The actual length of the tip 410 including the proximal hub may be within the range of from about 0.2 inches to about 0.8 inches and in some implementations within the range of from about 0.4 inches to about 0.6 inches.

[0181] The tip 410 may be manufactured in accordance with any of a variety of techniques known in the art, such as machining, etching, additive and / or subtractive processes. In one implementation, the tip 410 is molded from a polymer such as PEBAX, which may be a 55 D hardness. The PEBAX may include a radiopaque agent, such as bismuth sub carbonate, present in the range of from about 50% to about 70% by weight.

[0182] Any of the tip dimensions and configurations disclosed herein may be recombined with any of the other tip dimensions, configurations, drive shafts and associated structures depending upon the desired clinical performance.

[0183] Referring to Figures 19A - 19D, there is illustrated a split dilator system 450 which may be utilized with any of the catheters disclosed herein. The system includes a catheter 452 having an elongated tubular body 454 extending between a proximal end 456 and a distal end 458. Proximal end 456 is provided with a proximal hub or manifold 457 as has been discussed in connection with other catheters disclosed herein.

[0184] An elongate flexible dilator 460 has a length sufficient to extend throughout the entire length of the catheter 452. Dilator 460 extends between a proximal end 462 and a distal end 464 having a tapered distal tip 466. The dilator 460 is provided with a central lumen (not illustrated) so that it may be advanced over a guide wire 468. Proximal end 462 of the dilator is provided with a proximal hub 470.

[0185] A split 472 extends the length of the hub 470 and along the sidewall of the tubular dilator 460. The split may be in the form of a slot extending through the entire wall thickness of the dilator, a perforation line, a groove, or other weakening to allow the formation of a slit through the dilator side wall, and through which the guide wire 468 may be laterally removed as discussed further below. The longitudinal split 472 may extend the entire length of the dilator 460, or extend from the proximal end in a distal direction to an endpoint 473 within the range of from at least about 2 cm or 5 cm to no more than about 40 cm or 30 cm from the tapered tip 466.

[0186] Preferably, a first locking component carried by the hub 470 is releasably engageable with a complementary second locking component carried by the hub 457.

[0187] Referring to Figure 19 B, following trans vascular advance of the catheter and dilator assembly to the desired intravascular location, the dilator 460 may be proximally removed leaving the catheter 452 in place. Desirably, the guide wire 468 may remain unmoved in position at the target vascular site while removing the dilator 460, preferably without the need for a proximal guide wire extension. For this purpose, the guide wire 460 may be laterally progressively removed from the dilator at a parting point 473 that advances axially along the split 472, as the dilator 460 is proximally retracted from the catheter 452 and guidewire 468.

[0188] Once the tapered tip 466 has been proximally retracted from the catheter, the guide wire 468 may be grasped between the dilator 460 and the catheter 462, and the dilator 460 may be proximally removed from the catheter 452 and from the guide wire 468. This allows removal of the dilator without disturbing the position of the catheter or the guide wire, which are thereafter available for a subsequent intravascular procedure.

[0189] Referring to Figures 20 A and 20 B, there is illustrated a proximal dilator handle 480. The handle 480 comprises a body 482 having a proximal end 484 a distal end 486 and a longitudinal axis. At least a first proximal gripping surface 488 is canned by the body. In the illustrated implementation, a first gripping surface 488 is provided on at least one side of a paddle shaped grip 490, configured to be held between a thumb and forefinger. A second gripping surface 492 may be provided on an opposing side of the handle. Gripping surfaces may be provided with a friction enhancing surface structures such as a plurality of ridges oriented transverse to the longitudinal axis of the dilator handle 480.

[0190] A proximal exit port 494 in communication with the dilator guidewire lumen is oriented along the longitudinal axis of the dilator handle 480, such that a guide wire extending out of the exit port 494 lies along the first gripping surface 488. This allows a clinician to pin the guide wire to the gripping surface 488 using a finger such as a thumb, thereby enabling the dilator and the guide wire to be moved as a unit using one hand.

[0191] The dilator may be removably secured to the catheter such as by a retention clip 496 carried by the proximal end of the handle. A release such as a button or deformable interference snap fit may be provided to unlock the dilator handle from the housing, enabling the dilator to be proximally withdrawn from the catheter. In the illustrated implementation, a retention surface such as a proximal surface of a retention ring 497 carried by proximal end 486 of the body 482 provides an interference fit with the retention clip 496. This combines the dilator and handle / catheter into a single system. The paddle may be released from the retention clip by depressing at least a first button 506 and as illustrated also a second button 508 carried on the upper and lower sides of the retention clip housing, and proximally withdrawing the paddle.

[0192] This is the same connection and release dock for use with a thrombus engagement tool such as engagement tool 400 discussed in connection with Figures 16A and 16B. A distal limit safety feature on the thrombus engagement tool 400 fits into the retention clip 496, ensuring that the distal tip of the tool 400 can not be advanced forward beyond the distal tip of the catheter without both aligning a projection on the tool 400 with the rotational key 502 and intentionally advancing the tool 400 through the retention clip while depressing at least the first button 506 or other unlock control.

[0193] Once the distal limit has been released, the tip 410 may be distally advanced no more than about 4 cm and generally about 1 cm to 2 cm beyond the distal end of the catheter. This is intended to be accomplished once the thrombus engagement tool has been withdrawn from the patient, to allow visual inspection of the tip 410.

[0194] The engagement tool 400 may also be proximally retracted within the catheter, typically for less than about 3 cm or less than about 2 cm, and may be provided with a spring bias to return to approximate axial alignment between the distal end of the tip 410 and the distal end of the catheter.

[0195] A hemostasis clamp 500 may be provided, to hold the hemostasis valve open such as during shipping, or during the advance or withdrawal of devices therethrough. The hemostasis valve is opened by depressing at least a first control button, and in the illustrated implementation first and second control buttons positioned on opposing sides of the handle. The hemostasis clamp comprises a generally U shaped body 502 having a first arm 504configured to depress a first button, and a second opposing arm (not illustrated) configured to depress a second button on an opposite side of the handle. The hemostasis clamp 500 may be removably retained on the handle by a friction fit, or an interference fit between the handle and the body which can be overcome by plastic deformation as the body is pulled away from the handle to release the hemostasis control buttons.

[0196] Referring to Figure 21, an elongate flexible cannulated rail or dilator 561 is shown extending over the guidewire 570 and occupying the space between the guidewire 570 and the large inside diameter of the central lumen 558 of the large diameter catheter 560 to provide support to the catheter and / or an atraumatic tip during delivery.

[0197] This catheter-cannulated rail-guidewire assembly is intended to easily track through anatomical challenges more easily than the catheter. The catheter-rail-guidewire assembly then acts as a first stage of the catheter delivery system and enables the large diameter catheter or catheter system to be inserted and independently advanced over this first stage into a blood vessel (e.g. the femoral vein) percutaneously over a guidewire and advanced through potentially tortuous vasculature to the remote target location of interest without requiring advanced skills or causing kinking of the catheter.

[0198] The cannulated rail 561 may comprise a soft flexible cylindrical body having a guide wire lumen with a diameter of no more than about 0.040” and an outside diameter no less than about 0.025” or about 0.010” smaller than the inner diameter of the large diameter catheter. Thus the wall thickness of the cannulated rail 561 is typically at least about 0.010” less than the radius of the large diameter catheter and in some implementations at least about 0.120” or more, depending upon the size of the annular' space between the inside diameter of the catheter and the outside diameter of the guidewire.

[0199] The cannulated rail 561 may have an elongated tapered distal tip 562 that may project beyond the distal end 554 of the catheter 560. The thick sidewall of the cannulated rail 561 may comprise one or more flexible polymers, and may have one or more embeddedcolumn strength enhancing features such as axially extending wires, metal or polymeric woven or braided sleeve or a metal tube, depending upon the desired pushability and tracking performance along the length of the dilator.

[0200] Optionally, the proximal segment of the rail or dilator which is not intended to extend out of the distal end of the catheter may be a structure which is not coaxial with the guidewire, but a control wire which extends alongside the guidewire in the catheter and allows the distal tubular telescoping segment of the rail or dilator to be retracted or extended, (analogous to rapid exchange catheters) without the entire length of the rail structure being over the wire. This allows removal or insertion of the rail or dilator over a shorter guidewire because of the shorter coaxial segment tracking over the guidewire.

[0201] Catheter 560 may be provided with a proximal hub 520, having a port for axially movably receiving the rail 561 therethrough. The hub 520 may be provided with an engagement structure such as a first connector 522 for releasably engaging a second complementary connector 524 on a hub 526 on the proximal end of the rail 561. First connector 522 may comprise an interference structure such as at least one radially moveable projection 530, for releasably engaging a complementary engagement structure such as a recess 532 (e.g., an annular ridge or groove) on the hub 526. Distal advance of the rail 561 into the catheter 560 causes the projection 530 to snap fit into the recess 532, axially locking the catheter 560 and rail 561 together so that they may be manipulated as a unit.

[0202] The dilator is inserted through the hemostasis valve in the hub 520 of a large bore (e.g., 24F) catheter 560 and advanced through the catheter until the retention clip on the dilator hub 526 or catheter hub 520 snaps into the complementary recess on the other hub. In this engaged configuration, an advance segment along the flexible distal end of the 24F rail dilator 561 will extend at least about 5 cm or 10 cm, and in some implementations at least about 15 cm or 20 cm beyond the distal end 554 of the 24F catheter 560. The rail dilator and 24F catheter system are thereafter distally advanced over a previously placed guidewire and into the introducer sheath.

[0203] The dilator and catheter combination in some embodiments differentiate over prior systems both because of the flexibility of a distal zone of the dilator and greater length of the dilator than the corresponding catheter. Typically, a dilator is a uniform stiffness and length-matched to its catheter, with only a short atraumatic tip of the dilator extendingbeyond the distal end of the catheter. The dilator in some embodiments has a supportive proximal end and a flexible distal end, with a total dilator length much longer than the catheter 60 to enable, as an example, the following procedure.

[0204] In use, a guidewire 570 such as an 0.035” guidewire is advanced under fluoroscopy using conventional techniques into a selected vessel. The cannulated rail 561, optionally with the catheter 560 mounted thereon, is loaded over the proximal end of the guidewire 570 and advanced distally over the wire until the distal end of the rail is in position at the target site.

[0205] The 24F catheter 560 is thereafter unlocked from the rail 561 and advanced over the rail 561 to the desired site, supported by the rail 561 and guidewire 570 combination. Because the uncovered advance section of the rail has already traversed the challenging tortuosity through the heart, the catheter 561 now just slides over the advance section of the rail for easy passage to the final target location. The supportive proximal zone and flexible distal advance section of the rail enables ease of delivery through the most challenging anatomy in, for example, a PE procedure going from the vena cava through the tricuspid and pulmonary valves of the heart into the central pulmonary artery without concern about damaging the tissue (atraumatic, flexible tip) or damaging the dilator (high kink resistance due to flexible, high wall thickness “solid” dilator construction.

[0206] The cannulated rail 561, or the cannulated rail 561 and the guidewire 570 combination, may thereafter be proximally withdrawn, leaving the large bore catheter 560 in position to direct a procedure catheter such as any of the aspiration catheters disclosed elsewhere herein to the target site.

[0207] Referring to Figure 22, the large diameter (LD) catheter 560 may in some situations have a smaller diameter (SD) catheter though its central lumen for the purposes of introducing an additional functionality (e.g., clot grabber catheter 562, imaging catheter 10, or mechanical thrombectomy tool 66) and / or telescoping the SD catheter to more distal locations in the anatomy. In order to enable delivery of the LD catheter 560 and SD catheter as a single system, the SD catheter may have a core dilator 568 for support, and the gap between the outer diameter of the SD catheter and inner diameter of the LD catheter 560 may be maintained or supported by a second, tubular dilator 571. The tubular dilator 571 may have a shaped distal tip 572 for a smooth tapered transition from the SD catheter 541 to the LD catheter 540. Thedistal end 534 of the core dilator may be provided with a complementary taper to the distal taper of the thin wall SD dilator (Figure 23) or may end at the distal end of the LD catheter (Figure 24).

[0208] The core dilator 568 inside the SD catheter 541 and tubular dilator 570 between the two catheters may have an interlocking feature to create a single (SD + LD) catheter + (core + tubular) dilator system. For example, complementary connectors may be provided on hubs on the proximal ends of the system components.

[0209] Referring to Figure 24, the tip of the tubular dilator 570 may be configured to taper to the guidewire lumen 576, thus covering and extending distally beyond the small diameter catheter 541 if it is in place. The tip of the tubular dilator 570 may be provided with a longitudinally extending slit 578, scored or perforated one or more times to allow the tip to split longitudinally and be pulled back into the space between the LD and SD catheters and fully expose the distal end of the small diameter catheter 541. See Figure 25.

[0210] The single (SD + LD) catheter + (core + tubular) dilator system may be preassembled and detachably interlocked at the proximal hub. Additional tubular dilators having a series of outside diameters and wall thicknesses may be provided such that the SD catheter may be used in combination with different diameter LD catheters. A LD catheter may be used with different SD catheters by providing tubular dilators having the same OD but a series of different inside diameters. The core + tubular dilators may simply be pulled proximally to withdraw both dilators as a single system, or the tubular dilator may be configured with a tab or handle at the proximal end and a slit, scoring, perforation or other mechanism so as to split, peel, or tear it along the longitudinal axis during withdrawal to allow the tubular dilator to peel from the SD catheter as it slides proximally out of the space between the LD and SD catheters. (Figure 25).

[0211] Figures 26A through 29B illustrate another example of a hemostasis valve 1250 that can be used with arrangements of the catheters disclosed herein. In some cases, the hemostasis valve 1250 may incorporate some or all of the features from the hemostasis valve 250 described above. With initial reference to Figures 26A-27, Figure 26A depicts a perspective view of the hemostasis valve 1250. Figure 26B depicts the hemostasis valve 1250 of Figure 26A with a cutaway into the frame 1252. Figure 27 depicts an exploded view of the hemostasis valve 1250 shown in Figure 26A. Referring to Figures 26A-27, the hemostasisvalve 1250, as will be explained in more detail below, can include a combination of one or more of a frame 1252, a collapsible tubular sidewall 1254, a first actuator 1164, a second actuator 1174, a compression member 1259, and a biasing device 1400.

[0212] As seen in Figure 26A and 26B, the frame 1252 (which is shown in transparency in Figures 26A and 26B and in more detail in the exploded view of Figure 27) can provide a support structure whereby the collapsible tubular sidewall 1254, the first actuator 1164, the second actuator 1174, the compression member 1259, and the biasing device 1400 can be coupled to or attached to the frame 1252.The frame 1252 can include a housing member 1253, a support member 1248, and / or a lower portion 1249.

[0213] The frame 1252 can define a housing member 1253 which can have a generally cylindrical shape that is configured for housing the collapsible tubular sidewall 1254. The housing member 1253 can form a channel dimensioned to receive the collapsible tubular sidewall 1254. As seen in Figure 26A, the frame 1252 can include a support member 1248 extending from a top surface of the housing member 1253. In some embodiments, the support member 1248 can include a first pivot point 1266 and a second pivot point 1276 for movably coupling the first actuator 1164 and the second actuator 1174 to the support member 1248, as described below.

[0214] The frame 1252 can additionally include a lower portion 1249 extending from a bottom surface of the housing member 1253. As shown in Figures 26A-27, the lower portion 1249 can form a generally planar shape. The lower portion 1249 can include a first attachment point 1271 and a second attachment point 1279 for securing the compression member 1259 to the frame 1252. The first attachment point 1271 can be disposed on a first side 1390 of the frame 1252. The first attachment point 1271 can be disposed offset from the transverse midline of the housing member 1253 towards the first end 1256 of the hemostasis valve 1250. The second attachment point 1279 can be disposed on a second side 1392 of the frame 1252. The second side 1392 can be opposite to the first side 139. The second attachment point 1279 can be disposed offset from the transverse midline of the housing member towards the second end 1258 of the hemostasis valve 1250. In other embodiments, the first attachment point 1271 and the second attachment point 1279 can be disposed at any other location on the frame 1252. Additionally, in some embodiments, the first attachment point 1271 and the second attachment point 1279 may be the same point. The support member 1248 and the lowerportion 1249 can both extend from the housing member 1253 along substantially the same plane that extends through a longitudinal midiinc of the housing member 1253.

[0215] As shown in Figure 27, the frame 1252 can include a lateral opening 1261 configured to receive and allow movement of the first filament 1262 and the second filament 1263 through the frame 1252. The lateral opening 1261 can extend through the first and second sides 1390, 1392 of the housing member 1253. The lateral opening 1261 can be disposed at a transverse midline of the housing member 1253. As shown in Figure 27, the frame 1252 can be formed in two halves which can be coupled to each other. In other embodiments, the frame 1252 can be formed as a single integral component or formed by more than two components. In some cases, the frame 1252 may be integrally formed with or mounted to a housing 1106 or hub of a thrombectomy catheter 1102.

[0216] With continued reference to Figures 26A-27, the collapsible tubular sidewall 1254 can define a valve lumen 1255 extending between a first end 1256 and a second end 1258. As shown in Figure 26B, at least a portion 1260 of the collapsible tubular sidewall 1254 can collapse in response to external pressure. A portion 1260 and optionally the full length of the collapsible tubular sidewall 1254 within the hemostasis valve 1250 may comprise a collapsible elastic tube such as silicone tubing, which is biased into an open lumen tubular configuration when unconstrained. The collapsible tubular sidewall 1254 can be housed within or supported by the frame 1252 and can extend through the housing member 1253 as noted above. In some cases, the collapsible tubular sidewall 1254 can be configured to receive a device such as a guidewire, catheter, or other medical instrument that is inserted through the valve lumen 1255. The flow path and collapsible tubular sidewall 1254 can extend between the first end 1256 and the second end 1258. The first end 1256 may define or be in communication with a port 112, 1112 (see, e.g., Figure 9 and Figure 30) on the proximal end of any of the catheters disclosed herein. The second end 1258 may be in communication with the central lumen of the corresponding catheter, such that devices entering the first end 1256 and advanced axially through the flow path can advance all the way to the distal end of the catheter and beyond. For instance, the first end 1256 can be in communication with the port 1112 of a thrombectomy catheter 1102. The second end 1258 can be in communication with the central lumen 1294 extending to an elongate flexible tubular catheter body 1108.Additionally, devices inserted into the flow path can be removed by axially retracting the device and removing the device via the proximal end of the catheter.

[0217] The hemostasis valve 1250 can include a compression member 1259 configured to apply compressive force against the collapsible tubular sidewall 1254. When applying a compressive force on the collapsible tubular sidewall 1254, the compression member 1259 can reduce the inside diameter of the valve lumen 1255 to limit or stop fluid flow therethrough. When no devices are inserted through the hemostasis valve 1250, the compression member 1259 can completely close the valve lumen 1255 by sealing the collapsible tubular sidewall 1254 against itself. If a device such as a guidewire, catheter, or other medical instrument is inserted through the hemostasis valve 1250, the compression member 1259 can seal the collapsible tubular sidewall 1254 around the device. As shown in Figures 26B-27, the compression member 1259 can include a first filament 1262 and in certain implements also a second filament 1263. In the illustrated implementation, the first filament1262 can form a first loop 1268 around the collapsible portion 1260 of the collapsible tubular sidewall 1254, and the second filament 1263 can form a second loop 1269 around the collapsible portion 1260 of the collapsible tubular sidewall 1254. The first filament 1262 and the second filament 1263 can be tensioned at their opposing ends to reduce the diameters of the first loop 1268 and the second loop 1269. As the first filament 1262 and the second filament1263 are tensioned, the first loop 1268 and the second loop 1269 can circumferentially constrict the collapsible sidewall to close the valve lumen 1255 at least partially. Loosening of the first filament 1262 and the second filament 1263 can reduce the compressive force on the collapsible tubular sidewall 1254 to open the valve lumen 1255. Additional details on the tensioning and / or loosening of the first filament 1262 and / or the second filament 1263 are described below.

[0218] Tensioning of the first filament 1262 and the second filament 1263 may be facilitated by a first actuator 1164 and optionally a second actuator 1174. The first actuator 1164 and the second actuator 1174 can be moveably coupled to the frame 1252. As shown in FIG. 26 A, the first actuator 1164 can be a first lever 1264, and the second actuator can be a second lever 1274. With reference to Figures 28A and 28B, the first lever 1264 can be pivotably coupled to the frame 1252 at a first pivot point 1266, and the second lever 1274 can be pivotably coupled to the frame 1252 at a second pivot point 1276. As shown in Figure 27,the first pivot point 1266 and the second pivot point 1276 can be disposed on the support member 1248 of the frame 1252. In other embodiments, the first pivot point 1266 and the second pivot point 1276 can be disposed at other locations on the frame or be detached from the frame. The first pivot point 1266 and the second pivot point 1276 can each include a rod 1380 coupled to the support member 1248. In some cases, the first lever 1264 can include a first fulcrum 1272. The first fulcrum 1272 can be disposed at the distal end of the first lever 1264. The second lever 1274 can include a second fulcrum 1280. The second fulcrum 1280 can be disposed at the distal end of the second lever 1274. The distal ends of the first lever 1264 and the second lever 1274 can include the portions of the first lever 1264 and the second lever 1274 that are disposed distal to the pivot points. The distal ends of the first lever 1264 and the second lever 1274 can include portions of the first lever 1264 and the second lever 1274 that comprise equal to or less than 40% of the length of each of the first lever 1264 and the second lever 1274. Positioning the first fulcrum 1272 and the second fulcrum 1280 at the distal ends of the first lever 1264 and the second lever 1274 can provide a greater mechanical advantage relative to fulcrums positions midway along the lengths of first lever 1264 and the second lever 1274. In the illustrated configuration, the first fulcrum 1272 and the second fulcrum 1280 can each be formed by a pin 1372 that extends between opposing prongs 1374 at the distal ends of the first lever 1264 and the second lever 1274. The distal ends of the first lever 1264 and the second lever 1274 can include an opening 1376 (best seen in Figure 27) configured to allow the first filament 1262 and the second filament 1263 to slidably extend around the first fulcrum 1272 and the second fulcrum 1280. The first lever 1264 and the second lever 1274 can be configured to pivot about axes that are substantially parallel to a longitudinal axis Al of the collapsible tubular sidewall 1254. As shown in Figure 26 A, the first lever 1264 can pivot about a first pivot axis Bl and the second lever 1274 can pivot a second pivot axis B2. In the illustrated embodiment, the first pivot axis Bl and the second pivot axis B2 are spatially separated axes. In other embodiments, the first pivot axis B 1 and the second pivot axis B2 may be the same axis. Substantially parallel can refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 20 degrees and in certain embodiments departs from exactly parallel less than or equal to 10 degrees. As shown in Figures 28A and 28B, the distal ends of the first lever 1264 and the second lever 1274 can include arcuate portions 1364. The arcuate portions 1364 can be configured to conform to acurved outer surface of the housing member 1253 or the collapsible tubular sidewall 1254. It is to be understood that the first actuator 1164 and the second actuator 1174 arc not limited to being levers. In other embodiments, the first actuator 1164 and second actuator 1174 can be any type of actuator capable of tensioning one or more filaments, such as a rotatable actuator, linear actuator, slidable actuator, or the like. Additionally, other embodiments of the first actuator 1164 and / or the second actuator 1174 may include some or all of the features of the first lever 1264 and / or the second lever 1274.

[0219] Referring to Figures 26B-29C, the first filament 1262 can form the first loop 1268, a first intermediate portion 1265, a second intermediate portion 1267, a first tail portion 1270, and a second tail portion 1278. In the illustrated configuration, the first tail portion 1270 can be connected to the frame 1252 at a first attachment point 1271 (see Figures 26B and 27), and the second tail portion 1278 can be connected to the frame 1252 at a second attachment point 1279 (see Figures 26B and 27). As shown in Figure 26B, the first filament 1262 extends from its first tail portion 1270 at the first attachment point 1271, through the lateral opening1261 in the frame 1252, around the first fulcrum 1272 of the first lever 1264, around the collapsible tubular sidewall 1254 making a first loop 1268, around the second fulcrum 1280 of the second lever 1274, back through the lateral opening 1261 in the frame 1252, and then to the second attachment point 1279 at its second tail portion 1278. The first loop 1268 can include the portion of the first filament 1262 that circumferentially extends around the collapsible tubular sidewall 1254 to form a loop. The first intermediate portion 1265 can include the portion of the first filament 1262 that extends from the first loop 1268 towards the first lever 1264 and then slidably extends around the first fulcrum 1272. The first tail portion 1270 can include the portion of the first filament 1262 that extends from the first intermediate portion 1265 towards the frame 1252 and is connected to the frame 1252 at the first attachment point 1271. The second intermediate portion 1267 can include the portion of the first filament1262 that extends from the first loop 1268 towards the second lever 1274 and then slidably extends around the second fulcrum 1280. The second tail portion 1278 can include the portion of the first filament 1262 that extends from the second intermediate portion 1267 towards the frame 1252 and is connected to the frame 1252 at the second attachment point 1279.

[0220] The second filament 1263 can include the second loop 1269, a third intermediate portion 1273, a fourth intermediate portion 1275, a third tail portion 1277, and afourth tail portion 1281. In the illustrated configuration, the third tail portion 1277 can be connected to the frame 1252 at the first attachment point 1271 and the fourth tail portion 1278 can be connected to the frame 1252 at the second attachment point 1279. As shown in Figure 26B, the second filament 1263 extends from its third tail portion 1277 at the first attachment point 1271, through the lateral opening 1261 in the frame 1252, around the first fulcrum 1272 of the first lever 1264, around the collapsible tubular sidewall 1254 making a second loop 1269, around the second fulcrum 1280 of the second lever 1274, back through the lateral opening 1261 in the frame 1252, and to the second attachment point 1279 at its fourth tail portion 1281. The second loop 1269 can include the portion of the second filament 1263 that circumferentially extends around the collapsible tubular sidewall 1254 to form a loop. The third intermediate portion 1273 can include the portion of the second filament 1263 that extends from the second loop 1269 towards the first lever 1264 and then slidably extends around the first fulcrum 1272. The third tail portion 1277 can include the portion of the second filament 1263 that extends from the third intermediate portion 1273 towards the frame 1252 and is connected to the frame 1252 at the first attachment point 1271. The fourth intermediate portion 1275 can include the portion of the second filament 1263 that extends away from the second loop 1269 towards the second lever 1274 and then slidably extends around the second fulcrum 1280. The fourth tail portion 1281 can include the portion of the second filament 1263 that extends from the fourth intermediate portion 1275 towards the frame 1252 and is connected to the frame 1252 at the second attachment point 1279.

[0221] As illustrated in Figures 26-28B, the hemostasis valve 1250 can include a biasing device 1400. The biasing device 1400 can bias the hemostasis valve 1250 to a closed position. In the illustrated embodiment, the biasing device 1400 includes four springs attached to the frame 1252 and coupled to one of the first actuator 1164 or the second actuator 1174. A first spring 1282 can be coupled to the first lever 1264. The first spring 1282 can be configured to bias the first lever 1264 away from the collapsible tubular sidewall 1254. A second spring 1283 can be coupled to the second lever 1274. The second spring 1283 can be configured to bias the second lever 1274 away from the collapsible tubular sidewall 1254. The first spring 1282 and the second spring 1283 can be configured to move the first lever 1264 and the second lever 1274 in opposite directions away from the collapsible tubular sidewall 1254. A third spring 1284 can optionally be coupled to the first lever 1264. The first spring 1282 and thethird spring 1284 can be disposed on opposing sides of the first lever 1264. A fourth spring 1285 can optionally be coupled to the second lever 1274. The second spring 1283 and the fourth spring 1285 can be disposed on opposing sides of the second lever 1274. Biasing the first lever 1264 and the second lever 1274 away from the collapsible tubular sidewall 1254, causes the first filament 1262 and the second filament 1263 to constrict the collapsible tubular sidewall and maintain the valve lumen in a closed position without external user input. In other embodiments, the springs can be configured to bias the hemostasis valve 1250 to an open position. In the illustrated implementation, the biasing device 1400 includes springs. In other implementations, the biasing device 1400 can include any structure or mechanism for providing a resistive or biasing force on one or more actuators. For instance, the biasing device can include any of a spring, elastic band, shock absorber, or the like. In the illustrated implementation, the first spring 1282, the second spring 1283, the third spring 1284, and the fourth spring 1285 are torsion springs. In other implementations, the first spring 1282, the second spring 1283, the third spring 1284, and the fourth spring 1285 can comprise compression springs, coil springs, or any other spring type. In the illustrated embodiment, the torsion springs have a first end 1350 coupled to one of the levers and a second end 1352 that can be coupled to the frame.

[0222] In operation, the hemostasis valve 1250 can be transitioned between at least a first configuration in which the valve lumen 1255 is closed and a second configuration in which the valve lumen 1255 is at least partially open. The hemostasis valve 1250 can be transitioned between the first configuration and the second configuration by moving the first actuator 1164 and / or the second actuator 1174 between a first position and a second position. In the illustrated embodiment shown in Figures 28 A and 28B, the hemostasis valve 1250 can be transitioned between the first configuration and the second configuration by pivoting the first lever 1264 and / or the second lever 1274 between a first position and a second position. Figure 28A depicts the hemostasis valve 1250 in the first configuration in which the valve lumen 1255 is closed. When the hemostasis valve 1250 is in the first configuration, the flow of fluids, such as blood, is prevented through the valve lumen 1255. If a device such as a guidewire, catheter, or other medical instrument has been inserted through the valve lumen 1255, the collapsible tubular sidewall 1254 collapses around the device, creating a seal around the device to prevent fluid flow around the device. As shown in Figure 28A, when thehemostasis valve 1250 is in the first configuration, the resistive forces of the first spring 1282 and the second spring 1283 cause the first lever 1264 and the second lever 1274 to be held in the first position. In the first position, the first lever 1264 and the second lever 1274 are held in a position distal to the collapsible tubular sidewall 1254. When in this position, the first fulcrum 1272 and the second fulcrum 1280 contact and pull the first filament 1262 and the second filament 1263 away from the collapsible tubular sidewall 1254, causing the first filament 1262 and the second filament 1263 to be tensioned. Tensioning of the first filament 1262 and the second filament 1263 causes the first loop 1268 and the second loop 1269 to circumferentially constrict around the collapsible tubular sidewall 1254, resulting in the valve lumen 1255 partially or completely closing. If a device extends through the valve lumen 1255 when the hemostasis valve 1250 is in the first configuration, the device may still be advanced or retracted by application of a minimum threshold force to overcome the seal between the inner surface of the collapsible tubular sidewall 1254 and the device.

[0223] Figure 28B depicts the hemostasis valve 1250 in the second configuration in which the valve lumen 1255 is partially or completely open. When the hemostasis valve 1250 is in the second configuration, fluids, such as blood, can flow through the valve lumen 1255. The hemostasis valve 1250 may be moved to second configuration to permit a device such as a guidewire, catheter, or other medical instrument to be inserted through the valve lumen 1255. The hemostasis valve 1250 can be moved from the first configuration to the second configuration by depressing the first lever 1264 and the second lever 1274 towards the collapsible tubular sidewall 1254 to a second position. Depressing the first lever 1264 and the second lever 1274 requires the application of a force sufficient to overcome the resistive forces of the springs coupled to the first lever 1264 and the second lever 1274. Depressing the first lever 1264 and the second lever 1274 towards the collapsible tubular sidewall 1254 causes the first filament 1262 and the second filament 1263 to be loosened. As the first filament 1262 and the second filament 1263 are loosened, the first loop 1268 and the second loop 1269 increase in diameter, thereby releasing constrictive pressure on the collapsible tubular sidewall 1254 and opening the valve lumen 1255. The first lever 1264 and the second lever 1274 can be continuously depressed towards the collapsible tubular sidewall 1254 to cause the valve lumen 1255 to have any configuration between completely closed and completely open. Accordingly, the first lever 1264 and the second lever 1274 can be held at a specific distance from thecollapsible tubular sidewall 1254 to maintain a specific diameter of valve lumen 1255, allowing for variable control of the fluid flow rate through the valve lumen 1255. The first lever 1264 and the second lever 1274 can be fully depressed towards the collapsible tubular sidewall 1254 to completely open the valve lumen 1255. In this state, the first filament 1262 and the second filament 1263 may not exert a compressive force on the collapsible tubular sidewall 1254. Releasing the depressive forces on the first lever 1264 and the second lever 1274 causes the hemostasis valve 1250 to return to the first configuration in which the valve lumen 1255 is closed.

[0224] As explained below, one or more buttons, such as a first button 1290 and a second button 1292 (see Figures 32A and 32B), can be included to facilitate actuation of the first lever 1264 and the second lever 1274. The first lever 1264 and the second lever 1274 can pull the first intermediate portion 1265, the second intermediate portion 1267, the third intermediate portion 1273, and / or the fourth intermediate portion 1275 away from the tubular sidewall to reduce a diameter of the valve lumen 1255 by circumferentially constricting the first loop 1268 and the second loop 1269 around the tubular sidewall. As the first filament 1262 and the second filament 1263 are loosened or tensioned, the first filament 1262 and the second filament 1263 can slidably move around the first fulcrum 1272 and the second fulcrum 1280. The first fulcrum 1272 and the second fulcrum 1280 may contact different points along the first intermediate portion 1265, the second intermediate portion 1267, the third intermediate portion 1273, and the fourth intermediate portion 1275 as the hemostasis valve 1250 is moved between the first configuration and the second configuration. Friction between the first filament 1262 and / or the second filament 1263 around the first fulcrum 1272 and the second fulcrum 1280 can be minimized, such as by providing a lubricious oil such as silicone oil around the fulcrums at 280 and 272, and / or by using Teflon braided line for the first filament 1262 and / or the second filament 1263.

[0225] Figures 26A-26B depict an embodiment of the hemostasis valve 1250 having two actuators (first actuator 1164 and second actuator 1174). In other embodiments, the hemostasis valve 1250 can operate without a second actuator 1174. For instance, the hemostasis valve 1250 can include only the first actuator 1164 for tensioning the one or more filaments. In this configuration, the first and second filaments 1262, 1263 may each have a portion extending away from the collapsible tubular sidewall 1254 and coupled to the firstactuator. The first actuator 1164 may be moveable to pull the portions of the first and second filaments 1262, 1263 away from the collapsible tubular sidewall 1254 to reduce a diameter of the valve lumen 1255 by circumferentially constricting the first loop 1268 and the second loop 1269 around the collapsible tubular sidewall 1254. These portions of the first and second filaments, 1262, 1263 may correspond to the first intermediate portion 1265 and the third intermediate portion 1273 discussed above. Instead of being coupled to a second actuator 1174, the opposing portions (second or fourth intermediate portions 1267, 1275 and / or second or fourth tail portions 1278, 1281) of the first and second filaments 1262, 1263 may be fixedly coupled to the frame 1252 or other external object such that the opposing portions do not directly interact with an actuator.

[0226] Figures 29A-29C depict the looping pattern of the first filament 1262 and the second filament 1263 around the collapsible tubular sidewall 1254. Figure 29A depicts a bottom perspective view of the filamentary looping pattern. Figure 29B depicts a top view of the filamentary looping pattern. Figure 29C depicts a front view of the filamentary looping pattern. When looped around the collapsible tubular sidewall 1254, the first filament 1262 and the second filament 1263 can be disposed around the collapsible tubular sidewall 1254 such that the first loop 1268 and the second loop 1269 are adjacent to one another., i.e. side-by-side. The first loop 1268 and the second loop 1269 can be disposed around a transverse midline of the collapsible tubular sidewall 1254. The first loop 1268 can be disposed adjacent to the second loop 1269 such that the first loop 1268 is proximal to the second end 1256 of the hemostasis valve 1250 and the second loop 1269 is proximal to the first end 1256 of the hemostasis valve 1250. With reference to Figure 29A and following the path of the first filament 1262 from the first intermediate portion 1265 to the second intermediate portion 1267, the first filament 1262 extends at its first intermediate portion 1265 along a tangent line to a point of tangency on the underside of the collapsible tubular sidewall 1254. From the point of tangency, the first filament 1262 extends one full revolution around the collapsible tubular sidewall 1254 forming a first loop 1268. The first filament 1262 then extends at its second intermediate portion away from the collapsible tubular sidewall 1254 in a substantially opposite direction to the first intermediate portion 1265. With reference to the illustrated configuration, the first filament 1262 is wrapped inwardly around the collapsible tubular sidewall 1254 towards the first end 1256 of the collapsible tubular sidewall 1254 and towardsthe second filament 1263. At the point of tangency, the second intermediate portion 1267 is disposed to the side of the first intermediate portion 1265 and laterally displaced by the thickness of the first intermediate portion 1265. As a result, the second intermediate portion 1267 is laterally offset from the first intermediate portion 1265 and disposed relatively closer to the second loop 1269. Accordingly, the size of lateral offset can vary depending on the thickness of the first filament 1262.The first intermediate portion 1265 and the second intermediate portion 1267 extend away from the collapsible tubular sidewall 1254 in substantially opposite directions and within substantially the same plane. In other implementations, the first filament 1262 can be wrapped over itself such that the first intermediate portion 1265 and the second intermediate portion 1267 are not laterally offset.

[0227] Still with reference to Figure 29A and following the second filament 1263 from the third intermediate portion 1273 to the fourth intermediate portion 1275, the second filament 1263 extends at its third intermediate portion 1273 along a tangent line to a point of tangency on the underside of the collapsible tubular sidewall 1254. From the point of tangency, the second filament 1263 extends one full revolution around the collapsible tubular sidewall 1254 forming a second loop 1269. The second filament 1263 then extends at its fourth intermediate portion 1275 away from the collapsible tubular sidewall 1254 in a substantially opposite direction to the third intermediate portion 1273. With reference to the illustrated configuration, the second filament 1263 is wrapped inwardly around the collapsible tubular sidewall 1254 towards the second end 1258 of the collapsible tubular sidewall 1254 and towards the first filament 1262. At the point of tangency, the fourth intermediate portion 1275 is disposed to the side of the third intermediate portion 1273 and laterally displaced by the thickness of the third intermediate portion 1273. As a result, the fourth intermediate portion 1275 is laterally offset from the third intermediate portion 1273 and disposed relatively closer to the first loop 1269. Accordingly, the size of lateral offset can vary depending on the thickness of the second filament 1263. The third intermediate portion 1273 and the fourth intermediate portion 1275 extend away from the collapsible tubular sidewall 1254 in substantially opposite directions and within substantially the same plane. In other implementations, the second filament 1263 can be wrapped over itself such that the third intermediate portion 1273 and the fourth intermediate portion 1275 are not laterally offset.

[0228] As shown in Figures 29A-29C, the first filament 1262 and the second filament 1263 can be wrapped inwardly around the collapsible tubular sidewall 1254 such that the second intermediate portion 1267 and the fourth intermediate portion 1275 are disposed between the first intermediate portion 1265 and the third intermediate portion 1273. The second intermediate portion 1267 and the fourth intermediate portion 1275 can be disposed adjacent to one another in a closely spaced or touching relationship. The spacing between the first intermediate portion 1265 and the third intermediate portion 1273 can be greater than the spacing between the second intermediate portion 1267 and the fourth intermediate portion 1275. Additionally, the first intermediate portion 1265, the second intermediate portion 1267, the third intermediate portion 1273, and the fourth intermediate portion 1275 can all extend away from the collapsible tubular sidewall 1254 from one or more points of tangency disposed on substantially the same side of the collapsible tubular sidewall 1254 (underside of the collapsible tubular sidewall 1254 as depicted in Figures 29A-29C). In other words, the first intermediate portion 1265, the second intermediate portion 1267, the third intermediate portion 1273, and the fourth intermediate portion 1275 can all extend away from the collapsible tubular sidewall 1254 within substantially the same plane (illustrated as plane Pl in Figure 29A). The plane Pl can be tangent to an outer surface of the collapsible tubular sidewall 1254. Substantially the same plane can include lines or planes that depart from the tangent plane by less than or equal to 20 degrees and in certain embodiments less than or equal to 10 degrees. As shown in Figure 29C, the cross-sectional area of the collapsible tubular sidewall 1254 can be divided into four quadrants: a first quadrant QI, a second quadrant Q2, a third quadrant Q3, and a fourth quadrant Q4. In the illustrated embodiment, the first intermediate portion 1265, the second intermediate portion 1267, the third intermediate portion 1273, and the fourth intermediate portion 1275 all extend away from the collapsible tubular sidewall 1254 along tangent lines extending from points of tangency located within the first quadrant QI. Any of the first intermediate portion 1265, the second intermediate portion 1267, the third intermediate portion 1273, and the fourth intermediate portion 1275 can extend away from the collapsible tubular sidewall 1254 from points within the first quadrant QI and still be within substantially the same plane. In the illustrated configuration, the first intermediate portion 1265 and the third intermediate portion 1273 extend away from the first loop 1268 and the second loop 1269 in a first direction DI, and the second intermediate portion 1267 and the fourth intermediate portion1275 extend away from the first loop 1268 and the second loop 1269 in a second direction D2. In the illustrated configuration, the first direction DI is substantially opposite and parallel to the second direction D2. In other configurations, the first direction DI and second direction D2 may not be parallel. In the illustrated configuration, the first direction DI and the second direction are substantially orthogonal to the longitudinal axis Al of the collapsible tubular sidewall 1254. The first loop 1268 and the second loop 1269 may comprise one, two, three, or more revolutions around the collapsible tubular sidewall 1254, depending upon the desired performance.

[0229] As discussed above, opposing intermediate portions of each of the first filament 1262 and the second filament 1263 extend away from the collapsible tubular sidewall 1254 at lateral offsets. Specifically, the first intermediate portion 1265 is laterally offset from the second intermediate portion 1267, and the third intermediate portion 1273 is laterally offset from the fourth intermediate portion 1275. When two opposing intermediate portions are pulled in opposite directions to tighten the loop, the lateral offset causes a bending force to be imparted on the collapsible tubular sidewall 1254. In isolation, the bending force imparted by tensioning one of the filaments can cause undesirable bending of the collapsible tubular sidewall 1254. With reference to Figures 29A-29C, utilization of the illustrated filamentary looping arrangement can permit constriction of the collapsible tubular sidewall 1254 without bending of the collapsible tubular sidewall 1254. Specifically, in the illustrated embodiment, the first filament 1262 and the second filament 1263 are wrapped around the collapsible tubular sidewall 1254 in opposite directions towards each other (inwardly). Additionally, the first filament 1262 and the second filament 1263 are wrapped around the collapsible tubular sidewall 1254 such that the first filament 1262 and the second filament 1263 extend away from the collapsible tubular sidewall 1254 within substantially the same plane. With reference to Figure 29B, tensioning of the first filament 1262 can impart a counterclockwise bending moment on the collapsible tubular sidewall 1254, and tensioning of the second filament 1263 can impart a clockwise bending moment on the collapsible tubular sidewall. Accordingly, when wrapped around the collapsible tubular sidewall 1254 in the illustrated filamentary looping pattern, any bending moments imparted by the first filament 1262 are substantially counteracted or cancelled by the bending moments imparted by the second filament 1263 to produce a zero or near zero net bending moment. Additionally, since the first filament 1262and the second filament 1263 extend from the collapsible tubular sidewall 1254 within substantially the same plane (plane Pl as illustrated in FIG. 29 A), tensioning of the filaments does not produce other imbalances of bending forces that may occur if the first filament 1262 and the second filament 1263 extended from multiple or opposing sides or planes of the collapsible tubular sidewall 1254. Thus, the illustrated filamentary looping arrangement can provide a strong constrictive force while also reducing or eliminating unwanted bending of the collapsible tubular sidewall 1254.

[0230] In addition to preventing bending of the collapsible tubular sidewall 1254, the filamentary looping arrangement depicted in Figures 29A-29C, can also prevent cutting or shearing of the collapsible tubular sidewall by the filament. In some instances, use of only a single loop to constrict the collapsible tubular side wall 1254 may result in the filament cutting through or damaging the collapsible tubular sidewall. Use of multiple loops, such as a first loop 1268 and a second loop 1269, can reduce pressure on the collapsible tubular sidewall 1254 by increasing the surface area onto which constrictive forces are applied.

[0231] The first filament 1262 and the second filament 1263 can be joined together at their tail portions by a crimp. Specifically, the first tail portion 1270 and the third tail portion 1277 can be joined together by a first crimp 1288, and the second tail portion 1278 and the fourth tail portion 1281 can be joined together by a second crimp 1289. The first crimp 1288 can be attached to the frame 1252 at the first attachment point 1271 and the second crimp 1289 can be attached to the frame 1252 at the second attachment point 1279. In some implementations, the first filament 1262 and the second filament 1263 can be formed by a single continuous filament while maintaining the illustrated filamentary looping pattern.

[0232] As discussed above, the hemostasis valve 1250 can be configured to include one or more filaments including an intermediate portion extending around a fulcrum of a lever and a tail portion attached to a fixed attachment point such as the frame 1252. Arranging the one or more filaments to extend around a moveable fulcrum and fixedly attach to the frame can provide the lever and filament with greater mechanical advantage to constrict the collapsible tubular sidewall 1254. This arrangement can amplify forces by providing a 2:1 mechanical advantage. As discussed above, the mechanical advantage can also be increased by positioning the fulcrum at the distal end of the lever. Providing a hemostasis valve 1250 with these features to increase the mechanical advantage can enable the hemostasis valve 1250to comprise a small-form factor or smaller relative size while maintaining the ability to apply strong constrictive forces on the collapsible tubular sidewall 1254. A hemostasis valve 1250 with a small-form factor is advantageous at least because it is less bulky and more easily maneuverable during surgical operations.

[0233] In the implementation illustrated in Figures 26A-29C, the hemostasis valve 1250 includes a first filament 1262 and a second filament 1263. In some implementations, the hemostasis valve 1250 can include, one, two, three, or more filaments. Additionally, the one or more filaments can be arranged in various looping patterns. For instance, the one or more filaments can be arranged to extend from the collapsible tubular sidewall 1254 at various angles and from various sides of the collapsible tubular sidewall 1254. While the illustrated implementations show each of the first filament 1262 and the second filament 1263 as a single continuous member, in other implementations the first filament 1262 and the second filament 1263 can be formed from multiple members coupled together. For instance, one or more of the first loop 1269, first tail portion 1270, first intermediate portion 1265, second loop 1269, second tail portion 1278, second intermediate portion 1273, third tail portion 1277, third intermediate portion 1273, fourth tail portion 1281, and fourth intermediate portion 1275 can be separate members that are coupled together. The first filament 1262 and the second filament 1263 can be any type of tensile structure, such as a wire, cable, string, rope, band, thread, or the like. The first filament 1262 and the second filament 1263 can be formed from any type of material such as braided materials, wound materials, biocompatible materials, flexible materials, metals, steel, steel alloys, titanium, nickel alloys, polymers, polyester, nylon, fabrics, plastics, rubbers, organic materials, or the like.

[0234] Figures 30-32B depict a thrombectomy catheter 1102 according to an alternative implementation of the catheter shown in Figures 9-10A. The thrombectomy catheter 1102 can include some or all of the features or components of the other catheters, such as catheter 102, disclosed herein. The thrombectomy catheter 1102 can include the hemostasis valve 1250 depicted in Figures 26A-29C. The hemostasis valve 1250 can be coupled to a proximal end of the thrombectomy catheter 1102, or other catheter. Thrombectomy catheter 1102 can include a housing 1106 having an elongate flexible tubular catheter body 1108 extending distally therefrom. In some cases, the elongate flexible tubular catheter body 1108 can be permanently fixed to the housing 1106 and / or be removably secured to the housing1106. The housing 1106 is also referred herein to as a catheter handle or a proximal handle. The housing 1106 can be disposed around the hemostasis valve 1250, such that the hemostasis valve 1250 is contained within the housing 1106. A central lumen 1294 extending through the tubular catheter body 1108 can be in communication with a flow path extending through the housing 1106 to an access port 1112 at the proximal end of the thrombectomy catheter 1102. The flow path between the tubular catheter body 1108 and the access port 1112 can receive a second catheter which may or may not be utilized in a given procedure. To accommodate the absence of a second catheter and seal the port 1112, the housing 1106 can be provided with a hemostasis valve 1250. The hemostasis valve 1250 can be housed within the housing 1106 at a location proximal to the access port 1112. The first button 1290 and the second button 1292 can be moveably coupled to the housing 1106 to allow for manual actuation of the hemostasis valve 1250. A junction, such as a Y-junction 1300, can be disposed between the elongate flexible tubular catheter body 1108 and the hemostasis valve 1250. The Y-junction 1300 can comprise a portion of the flow path extending between the elongate flexible tubular catheter body 1108 and the hemostasis valve 1250.

[0235] Figure 31 depicts a longitudinal cross-sectional view of the thrombectomy catheter 1102 including a hemostasis valve 1250. The valve lumen 1255 can comprise a portion of the flow path extending between the Y-junction 1300 and the access port 1112. When the hemostasis valve 1250 is in the first configuration in which the valve lumen 1255 is closed, fluid flow can be prevented from flowing out of the valve lumen 1255 via the access port 1112. The hemostasis valve 1250 can be moved to the second configuration (shown in Figures 31 and 32B), in which the valve lumen 1255 is open, to allow for insertion of a second catheter, or other medical instrument, into the access port 1112 and through the tubular catheter body. Once a second catheter or other instrument has been inserted through the thrombectomy catheter 1102, the hemostasis valve 1250 can be returned to its first configuration to provide a seal around the interested medical instrument.

[0236] Figures 32A and 32B depict a transverse cross-sectional view of the thrombectomy catheter 1102 including a hemostasis valve 1250. Figure 32A depicts the hemostasis valve 1250 in the first configuration in which the valve lumen 1255 is closed. Figure 32B depicts the hemostasis valve 1250 in the second configuration in which the valve lumen 1255 is open. The first button 1290 and the second button 1292 can be manually actuatedto move the hemostasis valve 1250 between the first configuration and the second configuration. The first button 1290 can be disposed on the housing 1106 such that the first button 1290 contacts the first actuator 1164. Specifically, the first button 1290 can contact the distal end of the first lever 1264. The second button 1292 can be similarly disposed on the opposite side of the housing 1106 such that the second button 1292 contacts second actuator 1174. Specifically, the second button 1292 can contact the distal end of the second lever 1274. The first button 1290 and the second button 1292 can be simultaneously depressed inwards in a medial direction to cause the first lever 1264 and the second lever 1274 to pivot inwards towards the collapsible tubular sidewall 1254. As shown in Figure 32B, the first button 1290 and the second button 1292 can be depressed a minimum threshold distance to cause the valve lumen 1255 to open completely. Releasing the first button 1290 and the second button 1292 can return the hemostasis valve 1250 to the first configuration in which the valve lumen 1255 is closed.

[0237] Although these inventions have been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present inventions extend beyond the specifically disclosed embodiments to other alternative embodiments and / or uses of the inventions and obvious modifications and equivalents thereof. In addition, while several variations of the inventions have been shown and described in detail, other modifications, which are within the scope of these inventions, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combination or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the inventions. It should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed inventions. Further, the actions of the disclosed processes and methods may be modified in any manner, including by reordering actions and / or inserting additional actions and / or deleting actions. Thus, it is intended that the scope of at least some of the present inventions herein disclosed should not be limited by the particular disclosed embodiments described above. The limitations in the claims are to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive.

[0238] For purposes of this disclosure, certain aspects, advantages, and novel features arc described herein. Not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the ail will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0239] Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than 20% of, within less than 10% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 20 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degree, or otherwise.

[0240] Example Embodiments

[0241] An aspiration system with accelerated response, comprising one or more of the following:

[0242] an aspiration pump in communication with a first chamber;

[0243] an aspiration catheter configured for placement into fluid communication with the first chamber by way of an aspiration tube;

[0244] a second chamber in between the aspiration tube and the catheter; and

[0245] a valve between the second chamber and the aspiration catheter;

[0246] wherein upon opening of the valve with negative pressure in the first and second chambers, resistance to fluid flow between the second chamber and the distal end of the catheter is less than the resistance to fluid flow between the second chamber and the first chamber, causing a rapid aspiration into the second chamber.

[0247] An aspiration system as described in any embodiment herein, further comprising a handle on the aspiration catheter, and the second chamber is carried by the handle.

[0248] An aspiration system as described in any embodiment herein, further comprising a first control on the handle for opening the valve.

[0249] An aspiration system as described in any embodiment herein, wherein the valve is normally closed and actuation of the control momentarily opens the valve.

[0250] An aspiration system as described in any embodiment herein, further comprising a second control for activating the pump.

[0251] An aspiration system as described in any embodiment herein, further comprising a hemostasis valve earned by the handle.

[0252] An aspiration system as described in any embodiment herein, wherein the hemostasis valve comprises a collapsible tubular sidewall defining a valve lumen, and a filament formed into a loop around the tubular sidewall and configured to collapse the valve lumen.

[0253] An aspiration system as described in any embodiment herein, wherein the hemostasis valve further comprises a frame and a lever, and the filament has at least a first tail portion extending away from the loop, around a first fulcrum on the lever and is secured against axial movement with respect to the frame.

[0254] An aspiration system as described in any embodiment herein, wherein the first tail portion is connected to the frame.

[0255] An aspiration system as described in any embodiment herein, further comprising a second lever, and the filament further comprises a second tail portion extending from the loop, around a second fulcrum on the second lever and is connected to the frame.

[0256] An aspiration system as described in any embodiment herein, wherein the aspiration tube is at least about 50 inches long.

[0257] An aspiration system as described in any embodiment herein, wherein the second chamber is configured to capture clot aspirated by the catheter.

[0258] An aspiration system as described in any embodiment herein, wherein at least a portion of the second chamber is removably carried by the handle.

[0259] An aspiration system as described in any embodiment herein, wherein the second chamber comprises a filter membrane spaced apart from a transparent wall.

[0260] An aspiration system as described in any embodiment herein, comprising a tubular filter membrane, spaced radially inwardly apart from a transparent outer tubular wall.

[0261] An aspiration system as described in any embodiment herein, further comprising an operator actuated control, configured to toggle a flow regulator between a default low flow mode, and a momentary, operator initiated high flow override mode.

[0262] An aspiration system as described in any embodiment herein, wherein the second chamber is configured for location within a sterile field, and the first chamber is configured for location outside of the sterile field.

[0263] An aspiration system as described in any embodiment herein, further comprising a handle on the aspiration catheter, a tube between the handle and the second chamber, and the tube is no more than about 20 inches long.

[0264] A split dilator aspiration system, comprising one or more of the following:

[0265] a catheter, having an elongate, flexible tubular body with a proximal end , a distal end, a side wall defining a central lumen, and a handle on the proximal end; and

[0266] a dilator, advanceable through the central lumen, the dilator having an elongate body, cannulated to receive a guidewire, and an axially extending split along at least a portion of the elongate body, configured to allow removal of a portion of the dilator laterally from the guidewire.

[0267] A split dilator aspiration system as described in any embodiment herein, wherein the handle comprises a first engagement surface, and the dilator has a proximal hub with a second engagement surface configured to engage the first engagement surface to releasably secure the dilator within the catheter.

[0268] A split dilator aspiration system as described in any embodiment herein, comprising a retention clip carried by the proximal end of the catheter handle.

[0269] A split dilator aspiration system as described in any embodiment herein, further comprising a retention surface carried by the grip body.

[0270] A split dilator aspiration system as described in any embodiment herein, wherein the retention surface is on a retention ring configured to engage the retention clip.

[0271] A split dilator aspiration system as described in any embodiment herein, further comprising a release control, for disengaging the grip body from the catheter handle.

[0272] A split dilator aspiration system as described in any embodiment herein, wherein the release control comprises at least one push button.

[0273] A split dilator aspiration system as described in any embodiment herein, further comprising a clot container on the handle.

[0274] A split dilator aspiration system as described in any embodiment herein, further comprising a hemostasis valve on the handle.

[0275] A split dilator aspiration system as described in any embodiment herein, wherein the split comprises a weakening in the wall to permit the progressive formation of a slit through the wall to allow lateral escape of the guidewire.

[0276] A split dilator aspiration system as described in any embodiment herein, wherein the split comprises a pre formed slit completely through the wall.

[0277] A split dilator aspiration system as described in any embodiment herein, wherein the split extends to a distal endpoint spaced proximally apart from the distal end of the catheter.

[0278] A split dilator aspiration system as described in any embodiment herein, wherein the distal endpoint is spaced proximally apart within the range of from about 5 cm to about 40 cm from the distal end of the catheter.

[0279] A split dilator aspiration system as described in any embodiment herein, further comprising a proximal handle on the dilator.

[0280] A split dilator aspiration system as described in any embodiment herein, wherein the handle comprises a grip body having a first gripping surface and a guidewire exit port configured to direct a guidewire along the first gripping surface.

[0281] A split dilator aspiration system as described in any embodiment herein, wherein the body comprises a paddle shape with the first gripping surface on a first side and configured to be held between a thumb and forefinger such that a guidewire can be pinned between the thumb and the first gripping surface.

[0282] A split dilator aspiration system as described in any embodiment herein, further comprising friction enhancing surface structures on the first gripping surface.

[0283] A split dilator aspiration system as described in any embodiment herein, wherein the friction enhancing surface structures comprise a plurality of ridges.

[0284] A hemostasis valve, comprising one or more of the following:

[0285] a support;

[0286] at least a first lever, pivotably carried with respect to the support;

[0287] a collapsible tubular sidewall defining a valve lumen carried by the support;

[0288] a filament formed into a loop around the tubular sidewall, the filament having at least a first tail portion extending away from the loop to the first lever; and

[0289] a first spring configured to move the first lever in a direction that pulls the first tail portion away from the tubular sidewall, reducing the diameter of the valve lumen in response to reducing the diameter of the loop.

[0290] A hemostasis valve as described in any embodiment herein, further comprising a second lever pivotably carried with respect to the support.

[0291] A hemostasis valve as described in any embodiment herein, further comprising a second tail portion extending away from the loop and to the second lever.

[0292] A hemostasis valve as described in any embodiment herein, wherein the first tail portion, second tail portion and loop are one continuous filament.

[0293] A hemostasis valve as described in any embodiment herein, further comprising a lubricious coating on the filament.

[0294] A hemostasis valve as described in any embodiment herein, wherein the lubricious coating comprises silicone oil.

[0295] A hemostasis valve as described in any embodiment herein, wherein the first and second levers are biased in a direction that places the first and second tail portions under sufficient tension to reduce the diameter of the valve lumen and provide a seal around a device extending through the valve.

[0296] A hemostasis valve as described in any embodiment herein, wherein the first and second levers are biased in a direction that places the first and second tail portions under sufficient tension to close the valve.

[0297] A hemostasis valve as described in any embodiment herein, wherein the first tail portion is attached to the first lever.

[0298] A hemostasis valve as described in any embodiment herein, wherein the first tail portion slidably extends around a first fulcrum on the first lever, and is attached to the frame.

[0299] A hemostasis valve as described in any embodiment herein, wherein the second tail portion slidably extends around a second fulcrum on the second lever, and is attached to the frame.

[0300] A hemostasis valve as described in any embodiment herein, wherein the first and second fulcrums comprise pins.

[0301] A hemostasis valve as described in any embodiment herein, mounted on the proximal end of a catheter.

[0302] A hemostasis valve as described in any embodiment herein, further comprising a connector in communication with the valve lumen, configured for connection to a source of vacuum.

[0303] A vacuum aspiration system, comprising:

[0304] a housing;

[0305] a fluid flow path extending through the housing;

[0306] a first catheter in fluid communication with the flow path and a connector configured to place a source of aspiration in communication with the flow path;

[0307] a clot container carried by the housing; and

[0308] a hemostasis valve in the housing, configured to receive a second catheter and direct the second catheter through the first catheter.

[0309] A vacuum aspiration system as described in any embodiment herein, further comprising a flow regulator, configured to regulate fluid flow through the flow path.

[0310] A vacuum aspiration system as described in any embodiment herein, wherein at least a portion of the clot container is removably earned by the housing.

[0311] A vacuum aspiration system as described in any embodiment herein, wherein the clot container comprises a filter membrane spaced apart from a transparent wall.

[0312] A vacuum aspiration system as described in any embodiment herein, comprising a tubular filter membrane, spaced radially inwardly apart from a transparent outer tubular wall.

[0313] A vacuum aspiration system as described in any embodiment herein, further comprising an operator actuated control, configured to toggle the flow regulator between a default low flow mode, and a momentary, operator initiated high flow override mode.

[0314] A vacuum aspiration system as described in any embodiment herein, wherein the operator actuated control comprises a momentary control that places the system into the high flow override mode only when actuated by the operator.

[0315] A vacuum aspiration system as described in any embodiment herein, further comprising an on - off control which toggles between an off mode and the low flow mode.

[0316] A vacuum aspiration system as described in any embodiment herein, further comprising a side wall containing the flow path, and an optically transparent window in the side wall.

[0317] A vacuum aspiration system as described in any embodiment herein, wherein the flow regulator comprises a variable constriction in the flow path.

[0318] A vacuum aspiration system as described in any embodiment herein, wherein the flow regulator comprises a flexible flow path side wall and an actuator configured to compress the flexible side wall.

[0319] A vacuum aspiration system as described in any embodiment herein, comprising a flexible filament surrounding the side wall and at least one lever configured to place the filament under tension and close the valve by reducing the diameter of the side wall.

[0320] A vacuum aspiration system as described in any embodiment herein, further comprising at least one spring, biasing the lever in a direction that closes the valve.

[0321] A vacuum aspiration system as described in any embodiment herein, wherein the flow regulator comprises a tubing having an inside diameter and length to provide a desired flow rate.

[0322] A vacuum aspiration system as described in any embodiment herein, wherein the low flow mode aspirates fluid at a rate of no more than about lOcc / second and the high flow mode aspirates fluid at a rate of at least about 15 cc / second in an unobstructed aspiration.

[0323] A vacuum aspiration system, comprising:

[0324] a housing;

[0325] a fluid flow path extending through the housing;

[0326] a first catheter in fluid communication with the flow path and a connector configured to place a source of aspiration in communication with the flow path;

[0327] a flow regulator, configured to regulate fluid flow through the flow path;

[0328] a first operator actuated control, configured to toggle the flow regulator between a default, low flow mode, and a momentary, operator initiated high flow override mode; and

[0329] a second operator actuated control, configured to turn the fluid flow off.

[0330] A vacuum aspiration system as described in any embodiment herein, further comprising a port on the housing, in communication with the first connector and configured to guide a second catheter through the housing and into and through the first catheter.

[0331] A vacuum aspiration system as described in any embodiment herein, further comprising a hemostasis valve carried by the housing, in communication with the port.

[0332] A vacuum aspiration system as described in any embodiment herein, further comprising a reservoir carried by the housing, for receiving thrombus and blood retrieved through the first catheter.

[0333] A vacuum aspiration system as described in any embodiment herein, wherein the reservoir comprises a transparent tubular wall releasably caried by the housing.

[0334] A hemostasis valve, comprising one or more of the following:

[0335] a frame;

[0336] a first lever pivotably coupled to the frame, the first lever comprising a first fulcrum;

[0337] a second lever pivotably coupled to the frame, the second lever comprising a second fulcrum;

[0338] a collapsible tubular sidewall housed within the frame, the collapsible tubular sidewall defining a valve lumen;

[0339] a first filament formed into a first loop around the collapsible tubular sidewall, the first filament having: a first intermediate portion extending away from the first loop and slidably extending around the first fulcrum; and a second intermediate portion extending away from the first loop and slidably extending around the second fulcrum; and

[0340] a second filament formed into a second loop around the collapsible tubular sidewall, the second filament having: a third intermediate portion extending away from the second loop and slidably extending around the first fulcrum; and a fourth intermediate portion extending away from the second loop and slidably extending around the second fulcrum,

[0341] wherein the first intermediate portion, the second intermediate portion, the third intermediate portion, and the fourth intermediate portion extend away from the collapsible tubular sidewall within substantially a same plane,

[0342] wherein the first filament and the second filament are wrapped inwardly around the collapsible tubular sidewall towards each other such that the second intermediate portion and the fourth intermediate portion are disposed between the first intermediate portion and the third intermediate portion,

[0343] wherein the first lever and the second lever are moveable between a first position in which the first filament and the second filament are tensioned to close the valve lumen by circumferentially constricting the first loop and the second loop around the collapsible tubular sidewall and a second position in which the first filament and the second filament are loosened to least partially open the valve lumen.

[0344] A hemostasis valve as described in any embodiment herein, further comprising a biasing device configured to bias the first lever and the second lever to the first position, wherein the first lever and the second lever are configured to move to the second position in response to being depressed towards the collapsible tubular sidewall.

[0345] A hemostasis valve as described in any embodiment herein, wherein the biasing device comprises a first spring coupled to the first lever and a second spring coupled to the second lever.

[0346] A hemostasis valve as described in any embodiment herein, wherein the first intermediate portion and the third intermediate portion extend away from the collapsible tubular sidewall in a first direction, and wherein the second intermediate portion and the fourth intermediate portion extend away from the collapsible tubular sidewall in a second direction.

[0347] A hemostasis valve as described in any embodiment herein, wherein the first direction is opposite to the second direction.

[0348] A hemostasis valve as described in any embodiment herein, wherein: the first filament further comprises: a first tail portion extending from the first intermediate portion and connected to the frame; and a second tail portion extending from the second intermediate portion and connected to the frame; and the second filament further comprises: a third tail portion extending from the third intermediate portion and connected to the frame; and a fourth tail portion extending from the fourth intermediate portion and connected to the frame.

[0349] A hemostasis valve as described in any embodiment herein, wherein the first tail portion and the third tail portion are coupled together at a first attachment point on theframe, and wherein the second tail portion and the fourth tail portion are coupled together at a second attachment point on the frame.

[0350] A hemostasis valve as described in any embodiment herein, wherein the first fulcrum is disposed at a distal end of the first lever and the second fulcrum is disposed at a distal end of the second lever.

[0351] A hemostasis valve as described in any embodiment herein, further comprising: a housing disposed around the frame, the first lever, and the second lever; a first button moveably coupled to the housing, wherein the first button is actuatable to move the first lever; and a second button moveably coupled to the housing, wherein the second button is actuatable to move the second lever.

[0352] A hemostasis valve as described in any embodiment herein, wherein the first lever and the second lever are configured to pivot about axes that are parallel to a longitudinal axis of the collapsible tubular sidewall.

[0353] A hemostasis valve as described in any embodiment herein, wherein the hemostasis valve is coupled to a proximal end of a catheter.

[0354] A hemostasis valve, comprising one or more of the following:

[0355] a frame;

[0356] a first actuator moveably coupled to the frame;

[0357] a collapsible tubular sidewall housed within the frame, the collapsible tubular sidewall defining a valve lumen;

[0358] a first filament formed into a first loop around the collapsible tubular sidewall, the first filament having a portion extending away from the first loop and coupled to the first actuator; and

[0359] a second filament formed into a second loop around the collapsible tubular sidewall, the second filament having a portion extending away from the second loop and coupled to the first actuator,

[0360] wherein the portions of the first and second filaments extending away from the first and second loops, extend from the collapsible tubular sidewall within substantially a same plane, wherein the first actuator is moveable to pull the portions of the first and second filaments away from the collapsible tubular sidewall to reduce a diameter of the valve lumenby circumferentially constricting the first loop and the second loop around the collapsible tubular sidewall.

[0361] A hemostasis valve as described in any embodiment herein, further comprising a second actuator moveably coupled to the frame.

[0362] A hemostasis valve as described in any embodiment herein, wherein the portion of the first filament extending away from the first loop is a first intermediate portion, wherein the portion of the second filament extending away from the second loop is a third intermediate portion, wherein the first filament further comprises a second intermediate portion extending away from the first loop and coupled to the second actuator, wherein the second filament further comprises a fourth intermediate portion extending away from the second loop and coupled to the second actuator, and wherein the second actuator is moveable to pull the second intermediate portion and the fourth intermediate portion away from the collapsible tubular sidewall to reduce a diameter of the valve lumen by circumferentially constricting the first loop and the second loop around the collapsible tubular sidewall.

[0363] A hemostasis valve as described in any embodiment herein, wherein the second intermediate portion and the fourth intermediate portion extend from the collapsible tubular sidewall within substantially the same plane as the first intermediate portion and the third intermediate portion extend away from the collapsible tubular sidewall.

[0364] A hemostasis valve as described in any embodiment herein, wherein the first filament and the second filament are wrapped inwardly around the collapsible tubular sidewall towards each other such that the second intermediate portion and the fourth intermediate portion arc disposed between the first intermediate portion and the third intermediate portion.

[0365] A hemostasis valve as described in any embodiment herein, wherein the first actuator comprises a first lever pivotably coupled to the frame.

[0366] A hemostasis valve as described in any embodiment herein, wherein the first lever comprises a first fulcrum disposed at a distal end of the first lever, and wherein the portions of the first and second filaments slidably extend around the first fulcrum.

[0367] A hemostasis valve as described in any embodiment herein, wherein the first lever is configured to pivot about a first pivot axis that is parallel to a longitudinal axis of the collapsible tubular sidewall.

[0368] A hemostasis valve as described in any embodiment herein, further comprising a biasing device configured to bias the first actuator in a direction that places the portions of the first and second filaments under tension to close the valve lumen.

[0369] A hemostasis valve as described in any embodiment herein, further comprising: a housing disposed around the hemostasis valve; and a first button moveably coupled to the housing, wherein the first button is actuatable to move the first actuator.

[0370] A hemostasis valve, comprising one or more of the following:

[0371] a frame;

[0372] a first lever pivotably coupled to the frame about a first pivot axis;

[0373] a second lever pivotably coupled to the frame about a second pivot axis;

[0374] a collapsible tubular sidewall housed within the frame, the collapsible tubular sidewall defining a valve lumen extending along a longitudinal axis of the collapsible tubular sidewall; and

[0375] a first filament formed into a first loop around the collapsible tubular sidewall, wherein the first filament is coupled to the first lever and the second lever,

[0376] wherein the first pivot axis and the second pivot axis are substantially parallel to the longitudinal axis of the collapsible tubular sidewall.

[0377] A hemostasis valve as described in any embodiment herein, wherein the first lever comprises a first fulcrum disposed at a distal end of the first lever, and the second lever comprises a second fulcrum disposed at a distal end of the second lever.

[0378] A hemostasis valve as described in any embodiment herein, wherein the first filament comprises: a first intermediate portion extending away from the first loop and slidably extending around the first fulcrum; and a second intermediate portion extending away from the first loop and slidably extending around the second fulcrum.

[0379] A hemostasis valve as described in any embodiment herein, wherein the first intermediate portion and the second intermediate portion extend away from the first loop within substantially a same plane.

[0380] A hemostasis valve as described in any embodiment herein, wherein the first pivot axis is the same as the second pivot axis.

[0381] A hemostasis valve as described in any embodiment herein, wherein the first lever and the second lever are moveable between a first position in which the first filamentis tensioned to close the valve lumen by circumferentially constricting the first loop around the collapsible tubular sidewall and a second position in which the first filament is loosened to least partially open the valve lumen.

[0382] A hemostasis valve, comprising one or more of the following:

[0383] a frame;

[0384] a first lever pivotably coupled to the frame, the first lever comprising a first fulcrum;

[0385] a second lever pivotably coupled to the frame, the second lever comprising a second fulcrum;

[0386] a collapsible tubular sidewall housed within the frame, the collapsible tubular sidewall defining a valve lumen;

[0387] a first filament formed into a first loop around the collapsible tubular sidewall, the first filament having: a first intermediate portion extending away from the first loop and slidably extending around the first fulcrum; a second intermediate portion extending away from the first loop and slidably extending around the second fulcrum; a first tail portion extending from the first intermediate portion and connected to the frame; and a second tail portion extending from the second intermediate portion and connected to the frame;

[0388] wherein the first lever and the second lever are moveable between a first position in which the first filament and the second filament are tensioned to close the valve lumen by circumferentially constricting the first loop and the around the collapsible tubular sidewall and a second position in which the first filament and the second filament are loosened to least partially open the valve lumen.

Claims

WHAT TS CLAIMED TS:

1. A hemostasis valve, comprising: a frame; a first lever pivotably coupled to the frame, the first lever comprising a first fulcrum; a second lever pivotably coupled to the frame, the second lever comprising a second fulcrum; a collapsible tubular sidewall housed within the frame, the collapsible tubular sidewall defining a valve lumen; a first filament formed into a first loop around the collapsible tubular sidewall, the first filament having: a first intermediate portion extending away from the first loop and slidably extending around the first fulcrum; and a second intermediate portion extending away from the first loop and slidably extending around the second fulcrum; and a second filament formed into a second loop around the collapsible tubular sidewall, the second filament having: a third intermediate portion extending away from the second loop and slidably extending around the first fulcrum; and a fourth intermediate portion extending away from the second loop and slidably extending around the second fulcrum, wherein the first intermediate portion, the second intermediate portion, the third intermediate portion, and the fourth intermediate portion extend away from the collapsible tubular sidewall within substantially a same plane, wherein the first filament and the second filament are wrapped inwardly around the collapsible tubular sidewall towards each other such that the second intermediate portion and the fourth intermediate portion are disposed between the first intermediate portion and the third intermediate portion, wherein the first lever and the second lever are moveable between a first position in which the first filament and the second filament are tensioned to close the valve lumen by circumferentially constricting the first loop and the second loop around the collapsible tubular sidewall and a second position in which the first filament and the second filament are loosened to least partially open the valve lumen.

2. A hemostasis valve as in Claim 1 , further comprising a biasing device configured to bias the first lever and the second lever to the first position, wherein the first lever and the second lever are configured to move to the second position in response to being depressed towards the collapsible tubular sidewall.

3. A hemostasis valve as in Claim 2, wherein the biasing device comprises a first spring coupled to the first lever and a second spring coupled to the second lever.

4. A hemostasis valve as in Claim 1, wherein the first intermediate portion and the third intermediate portion extend away from the collapsible tubular sidewall in a first direction, and wherein the second intermediate portion and the fourth intermediate portion extend away from the collapsible tubular sidewall in a second direction.

5. A hemostasis valve as in Claim 4, wherein the first direction is opposite to the second direction.

6. A hemostasis valve as in Claim 1, wherein: the first filament further comprises: a first tail portion extending from the first intermediate portion and connected to the frame; and a second tail portion extending from the second intermediate portion and connected to the frame; and the second filament further comprises: a third tail portion extending from the third intermediate portion and connected to the frame; and a fourth tail portion extending from the fourth intermediate portion and connected to the frame.

7. A hemostasis valve as in Claim 6, wherein the first tail portion and the third tail portion are coupled together at a first attachment point on the frame, and wherein the second tail portion and the fourth tail portion are coupled together at a second attachment point on the frame.

8. A hemostasis valve as in Claim 1, wherein the first fulcrum is disposed at a distal end of the first lever and the second fulcrum is disposed at a distal end of the second lever.

9. A hemostasis valve as in Claim 1, further comprising: a housing disposed around the frame, the first lever, and the second lever;a first button moveably coupled to the housing, wherein the first button is actuatablc to move the first lever; and a second button moveably coupled to the housing, wherein the second button is actuatable to move the second lever.

10. A hemostasis valve as in Claim 1, wherein the first lever and the second lever are configured to pivot about axes that are parallel to a longitudinal axis of the collapsible tubular sidewall.

11. A hemostasis valve as in Claim 1, wherein the hemostasis valve is coupled to a proximal end of a catheter.

12. A hemostasis valve, comprising: a frame; a first actuator moveably coupled to the frame; a collapsible tubular sidewall housed within the frame, the collapsible tubular sidewall defining a valve lumen; a first filament formed into a first loop around the collapsible tubular sidewall, the first filament having a portion extending away from the first loop and coupled to the first actuator; and a second filament formed into a second loop around the collapsible tubular sidewall, the second filament having a portion extending away from the second loop and coupled to the first actuator, wherein the portions of the first and second filaments extending away from the first and second loops, extend from the collapsible tubular sidewall within substantially a same plane, wherein the first actuator is moveable to pull the portions of the first and second filaments away from the collapsible tubular sidewall to reduce a diameter of the valve lumen by circumferentially constricting the first loop and the second loop around the collapsible tubular sidewall.

13. A hemostasis valve as in Claim 12, further comprising a second actuator moveably coupled to the frame.

14. A hemostasis valve as in Claim 13, wherein the portion of the first filament extending away from the first loop is a first intermediate portion, wherein the portion of the second filament extending away from the second loop is a third intermediate portion, whereinthe first filament further comprises a second intermediate portion extending away from the first loop and coupled to the second actuator, wherein the second filament further comprises a fourth intermediate portion extending away from the second loop and coupled to the second actuator, and wherein the second actuator is moveable to pull the second intermediate portion and the fourth intermediate portion away from the collapsible tubular sidewall to reduce a diameter of the valve lumen by circumferentially constricting the first loop and the second loop around the collapsible tubular sidewall.

15. A hemostasis valve as in Claim 14, wherein the second intermediate portion and the fourth intermediate portion extend from the collapsible tubular’ sidewall within substantially the same plane as the first intermediate portion and the third intermediate portion extend away from the collapsible tubular sidewall.

16. A hemostasis valve as in Claim 15, wherein the first filament and the second filament are wrapped inwardly around the collapsible tubular sidewall towards each other such that the second intermediate portion and the fourth intermediate portion are disposed between the first intermediate portion and the third intermediate portion.

17. A hemostasis valve as in Claim 12, wherein the first actuator comprises a first lever pivotably coupled to the frame.

18. A hemostasis valve as in Claim 17, wherein the first lever comprises a first fulcrum disposed at a distal end of the first lever, and wherein the portions of the first and second filaments slidably extend around the first fulcrum.

19. A hemostasis valve as in Claim 17, wherein the first lever is configured to pivot about a first pivot axis that is parallel to a longitudinal axis of the collapsible tubular sidewall.

20. A hemostasis valve as in claim 12, further comprising a biasing device configured to bias the first actuator in a direction that places the portions of the first and second filaments under tension to close the valve lumen.

21. A hemostasis valve as in Claim 12, further comprising: a housing disposed around the hemostasis valve; and a first button moveably coupled to the housing, wherein the first button is actuatable to move the first actuator.

22. A hemostasis valve, comprising: a frame;a first lever pivotably coupled to the frame about a first pivot axis; a second lever pivotably coupled to the frame about a second pivot axis; a collapsible tubular- sidewall housed within the frame, the collapsible tubular sidewall defining a valve lumen extending along a longitudinal axis of the collapsible tubular sidewall; and a first filament formed into a first loop around the collapsible tubular sidewall, wherein the first filament is coupled to the first lever and the second lever, wherein the first pivot axis and the second pivot axis are substantially parallel to the longitudinal axis of the collapsible tubular sidewall.

23. A hemostasis valve as in claim 22, wherein the first lever comprises a first fulcrum disposed at a distal end of the first lever, and the second lever comprises a second fulcrum disposed at a distal end of the second lever.

24. A hemostasis valve as in claim 23, wherein the first filament comprises: a first intermediate portion extending away from the first loop and slidably extending around the first fulcrum; and a second intermediate portion extending away from the first loop and slidably extending around the second fulcrum.

25. A hemostasis valve as in Claim 24, wherein the first intermediate portion and the second intermediate portion extend away from the first loop within substantially a same plane.

26. A hemostasis valve as in Claim 22, wherein the first pivot axis is the same as the second pivot axis.

27. A hemostasis valve as in Claim 22, wherein the first lever and the second lever are moveable between a first position in which the first filament is tensioned to close the valve lumen by circumferentially constricting the first loop around the collapsible tubular sidewall and a second position in which the first filament is loosened to least partially open the valve lumen.

28. A hemostasis valve, comprising: a frame; a first lever pivotably coupled to the frame, the first lever comprising a first fulcrum;a second lever pivotably coupled to the frame, the second lever comprising a second fulcrum; a collapsible tubular- sidewall housed within the frame, the collapsible tubular sidewall defining a valve lumen; a first filament formed into a first loop around the collapsible tubular sidewall, the first filament having: a first intermediate portion extending away from the first loop and slidably extending around the first fulcrum; a second intermediate portion extending away from the first loop and slidably extending around the second fulcrum; a first tail portion extending from the first intermediate portion and connected to the frame; and a second tail portion extending from the second intermediate portion and connected to the frame; wherein the first lever and the second lever are moveable between a first position in which the first filament and the second filament are tensioned to close the valve lumen by circumferentially constricting the first loop and the around the collapsible tubular sidewall and a second position in which the first filament and the second filament are loosened to least partially open the valve lumen.

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