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WO2025178639A1 - Valve hémostatique - Google Patents

Valve hémostatique

Info

Publication number
WO2025178639A1
WO2025178639A1 PCT/US2024/018164 US2024018164W WO2025178639A1 WO 2025178639 A1 WO2025178639 A1 WO 2025178639A1 US 2024018164 W US2024018164 W US 2024018164W WO 2025178639 A1 WO2025178639 A1 WO 2025178639A1
Authority
WO
WIPO (PCT)
Prior art keywords
lever
filament
intermediate portion
loop
tubular sidewall
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/018164
Other languages
English (en)
Inventor
Michael Buck
Julia FOX
James Jacobs
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Imperative Care Inc
Original Assignee
Imperative Care Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Imperative Care Inc filed Critical Imperative Care Inc
Publication of WO2025178639A1 publication Critical patent/WO2025178639A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/79—Filters for solid matter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00685—Archimedes screw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B2017/22034—Gripping instruments, e.g. forceps, for removing or smashing calculi for gripping the obstruction or the tissue part from inside
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22079—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with suction of debris
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/007—Auxiliary appliance with irrigation system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/12—Blood circulatory system

Definitions

  • 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.
  • VTE Venous thromboembolic disease
  • DVT deep vein thrombosis
  • PE pulmonary embolism
  • DVT and PE are part of the same continuum of disease, with over 95% of emboli originating in the lower extremities.
  • PE 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.
  • PA pulmonary artery
  • RV right ventricular
  • PE pulmonary embolism
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • the hemostasis valve can be mounted on a proximal end of a catheter.
  • the present disclosure provides a hemostasis valve including a frame, a first actuator moveably 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 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 hemostasis valve can further include a second actuator moveably coupled to the frame.
  • the portion of the first filament extending away from the first loop is a first intermediate portion
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the first lever can comprise a first fulcrum disposed at a distal end of the first lever
  • the second lever can comprise a second fulcrum disposed at a distal end of the second lever
  • 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.
  • first intermediate portion and the second intermediate portion can extend away from the first loop within substantially a same plane.
  • first pivot axis is the same as the second pivot axis.
  • 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.
  • 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 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.
  • Figure 1 is a schematic view of a fluid management system in accordance with one embodiment.
  • 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.
  • 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.
  • Figure 4 is a schematic view as in Figure 3, with the clot advancing towards a thrombus collection chamber.
  • Figure 5 is a schematic view as in Figure 4, with the clot deposited in a transparent thrombus collection chamber.
  • Figure 6 is a schematic view of a thrombectomy system configured to reinfuse filtered aspirated blood back into a patient.
  • Figure 7 A is a schematic view of an alternate configuration of the fluid management system.
  • Figure 7B is a schematic view of an alternate configuration of the fluid management system.
  • Figure 8 is a schematic view of a grasping catheter configured to apply suction to a clot.
  • Figure 9 is a schematic view of an alternative aspiration system having a first thrombectomy catheter and a second thrombectomy catheter extending therethrough.
  • Figure 11C is a qualitative fluid flow rate diagram at the catheter tip, following opening of the momentary vacuum control valve.
  • Figures 13A-13C illustrate three flow configurations for a three-way valve.
  • Figure 17B is a longitudinal cross-section through the tip of Figure 17A.
  • Figure 24 is a cross section as in Figure 23, with a distal tip formed by the tubular dilator.
  • Figure 31 is a longitudinal cross-section view of the thrombectomy system of Figure 30.
  • 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.
  • 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.
  • 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.
  • a mechanical control such as a lever or rotatable knob
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the secondary catheter is in the form of a second aspiration catheter 42 which has been distally advanced through the access catheter 12 and through 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.
  • 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.
  • 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.
  • 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.
  • 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 blood from 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.
  • 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.
  • the first valve 72 and second valve 76 are one way flapper valves that open or close in response to blood flow direction.
  • 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.
  • 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.
  • the smaller tubular body 152 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.
  • 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.
  • the sidewall of tubular body 108 may include a tubular braid, importing greater stiffness and higher push ability than the helical coil 113.
  • 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.
  • the proximal handle 106 is preferably provided with a hemostasis valve 114 such as a Thuohy-Borst valve.
  • 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.
  • manifold switch 116 can be configured to turn aspiration one and off.
  • 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.
  • 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.
  • 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.
  • 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.
  • the present implementation includes an integrated flow control module in the proximal handle 106.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the catheter handle 106 or 140 contains a filter chamber 128 for example, which is in communication with the vacuum cannister on the pump by 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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]
  • FIG. 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.
  • 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.
  • 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
  • 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.
  • the core wire and tip e.g., thrombus engagement tool 400
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • distal extension of the distal end of the helical tip beyond the distal end of the catheter may 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.
  • 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.
  • 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.
  • Distal advance of the tip 420 may be limited by providing mechanical interference at the desired distal limit of travel.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 the length of the micro lumen shaft and tip 410 so that the thrombus engagement tool can be introduced over the wire.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a first locking component carried by the hub 470 is releasably engageable with a complementary second locking component carried by the hub 457.
  • 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.
  • a proximal dilator 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a blood vessel e.g. the femoral vein
  • 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.
  • 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.
  • 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 embedded column 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.
  • 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.
  • 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.
  • 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.
  • a large bore catheter 560 e.g., 24F
  • 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.
  • 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.
  • a dilator is a uniform stiffness and length-matched to its catheter, with only a short atraumatic tip of the dilator extending beyond 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the distal 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).
  • 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.
  • complementary connectors may be provided on hubs on the proximal ends of the system components.
  • 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.
  • 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 lower portion 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.
  • first actuator 1164 and the second actuator 1174 can be moveably coupled to the frame 1252.
  • first actuator 1164 can be a first lever 1264
  • second actuator can be a second lever 1274.
  • first lever 1264 can be pivotably coupled to the frame 1252 at a first pivot point 1266
  • the second lever 1274 can be pivotably coupled to the frame 1252 at a second pivot point 1276.
  • first pivot point 1266 and the second pivot point 1276 can be disposed on the support member 1248 of the frame 1252.
  • 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.
  • 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.
  • the arcuate portions 1364 can be configured to conform to a curved 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.
  • 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.
  • the first tail portion 1270 can be connected to the frame 1252 at a first attachment point 1271 (see Figures 26B and 27)
  • the second tail portion 1278 can be connected to the frame 1252 at a second attachment point 1279 (see Figures 26B and 27).
  • the first filament 1262 extends from its first tail portion 1270 at the first attachment point 1271, through the lateral opening
  • 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 filament
  • 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.
  • 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 a fourth tail portion 1281.
  • 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.
  • 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.
  • the hemostasis valve 1250 can include a biasing device 1400.
  • the biasing device 1400 can bias the hemostasis valve 1250 to a closed position.
  • 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, the second spring 1283, the third spring 1284, and the fourth spring 1285 are torsion springs.
  • 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.
  • 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.
  • 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.
  • 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.
  • the flow of fluids such as blood
  • a device such as a guidewire, catheter, or other medical instrument
  • the collapsible tubular sidewall 1254 collapses around the device, creating a seal around the device to prevent fluid flow around the device.
  • 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.
  • 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 the collapsible 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.
  • 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.
  • 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.
  • a lubricious oil such as silicone oil around the fulcrums at 280 and 272
  • Teflon braided line for the first filament 1262 and/or the second filament 1263 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.
  • FIGS 26A-26B depict an embodiment of the hemostasis valve 1250 having two actuators (first actuator 1164 and second actuator 1174).
  • the hemostasis valve 1250 can operate without a second actuator 1174.
  • the hemostasis valve 1250 can include only the first actuator 1164 for tensioning the one or more filaments.
  • the first and second filaments 1262, 1263 may each have a portion extending away from the collapsible tubular sidewall 1254 and coupled to the first actuator.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 towards the second filament 1263.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • second intermediate portion 1267 and the fourth intermediate portion 1275 extend away from the first loop 1268 and the second loop 1269 in a second direction D2.
  • 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.
  • 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.
  • 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.
  • the first intermediate portion 1265 is laterally offset from the second intermediate portion 1267
  • the third intermediate portion 1273 is laterally offset from the fourth intermediate portion 1275.
  • the lateral offset causes a bending force to be imparted on the collapsible tubular sidewall 1254.
  • the bending force imparted by tensioning one of the filaments can cause undesirable bending of the collapsible tubular sidewall 1254.
  • 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.
  • tensioning of the first filament 1262 can impart a counterclockwise bending moment on the collapsible tubular sidewall 1254
  • 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 1262 and the second filament 1263 extend from the collapsible tubular sidewall 1254 within substantially the same plane (plane Pl as illustrated in FIG.
  • 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.
  • the illustrated filamentary looping arrangement can provide a strong constrictive force while also reducing or eliminating unwanted 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.
  • 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.
  • 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.
  • the first filament 1262 and the second filament 1263 can be formed by a single continuous filament while maintaining the illustrated filamentary looping pattern.
  • 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 1250 to 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.
  • a hemostasis valve in the housing, configured to receive a second catheter and direct the second catheter through the first catheter.
  • 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.
  • 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.
  • a vacuum aspiration system comprising:
  • 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;
  • a flow regulator configured to regulate fluid flow through the flow path
  • 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.
  • 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.
  • 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.
  • a hemostasis valve comprising one or more of the following:
  • 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
  • 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
  • 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
  • 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.
  • a hemostasis valve comprising one or more of the following:
  • 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;
  • 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
  • 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.
  • a hemostasis valve comprising one or more of the following:
  • 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;
  • 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,
  • first pivot axis and the second pivot axis are substantially parallel to the longitudinal axis of the collapsible tubular sidewall.
  • a hemostasis valve comprising one or more of the following:
  • 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;
  • 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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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Molecular Biology (AREA)
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Abstract

Une valve hémostatique peut être utilisée avec un cathéter d'aspiration et/ou de thrombectomie. La valve hémostatique peut être déplacée entre une première configuration dans laquelle la lumière de valve est fermée et une deuxième configuration dans laquelle la lumière de valve est ouverte. La valve hémostatique peut comprendre un cadre, une paroi latérale tubulaire pliable, un premier filament, un deuxième filament, un premier levier et un deuxième levier. Les premier et deuxième filaments peuvent être formés en des première et deuxième boucles respectives autour de la paroi latérale tubulaire pliable. Les premier et deuxième filaments peuvent être avancés de manière coulissante autour des premier et deuxième leviers. Les premier et deuxième leviers peuvent être enfoncés pour tendre les premier et deuxième filaments, entraînant les première et deuxième boucles à resserrer de manière circonférentielle la paroi latérale tubulaire pliable et à fermer la lumière de valve. La valve hémostatique peut être sollicitée vers la première configuration par un dispositif de sollicitation.
PCT/US2024/018164 2024-02-23 2024-03-01 Valve hémostatique Pending WO2025178639A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463557439P 2024-02-23 2024-02-23
US63/557,439 2024-02-23

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WO2025178639A1 true WO2025178639A1 (fr) 2025-08-28

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4634421A (en) * 1985-07-26 1987-01-06 Johnson & Johnson Products Inc. Valve for incontinent patients
US20030116731A1 (en) * 2001-12-04 2003-06-26 William A. Cook Australia Pty Ltd. Access valve
US20210316121A1 (en) * 2019-12-18 2021-10-14 Imperative Care, Inc. Split dilator aspiration system
US11697012B2 (en) * 2017-09-06 2023-07-11 Inari Medical, Inc. Hemostasis valves and methods of use

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4634421A (en) * 1985-07-26 1987-01-06 Johnson & Johnson Products Inc. Valve for incontinent patients
US20030116731A1 (en) * 2001-12-04 2003-06-26 William A. Cook Australia Pty Ltd. Access valve
US11697012B2 (en) * 2017-09-06 2023-07-11 Inari Medical, Inc. Hemostasis valves and methods of use
US20210316121A1 (en) * 2019-12-18 2021-10-14 Imperative Care, Inc. Split dilator aspiration system

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