Reversing thrombectomy device and method of use

Abstract

To provide apparatuses and methods for mechanical removal of objects from within a body, in particular for mechanical thrombectomy.SOLUTION: Described herein are mechanical inverting tube apparatuses used to remove a clot (e.g., thrombectomy). The apparatuses include an inversion support catheter having an expandable funnel-shaped distal end, and a flexible tube that can be continuously rolled over the funnel-shaped distal end and invert into an inner lumen of the inversion support catheter.SELECTED DRAWING: Figure 24B

Description

[Technical Field]

[0001] The devices and methods described herein relate to the mechanical removal of objects from the body. In particular, mechanical thrombectomy devices and methods are described herein.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims priority to U.S. Provisional Patent Application No. 62 / 729,276, entitled "INVERTING THROMBECTOMY APPARATUSES FOR REMOVAL OF LARGE CLOTS," filed September 10, 2018, which is incorporated herein by reference in its entirety.

[0003] Incorporation by Reference All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. [Background technology]

[0004] Many vascular problems result from insufficient blood flow through blood vessels. One cause of insufficient or irregular blood flow is a blockage in a blood vessel called a thrombus or embolus. Thrombi can form for many reasons, including after trauma, such as surgery, or due to other causes. For example, the majority of over 1.2 million heart attacks in the United States are caused by blood clots (emboli) forming in the coronary arteries. It is often desirable to remove tissue from the body in as minimally invasive a manner as possible to avoid damaging other tissues. For example, removing tissue, such as a thrombus, from a patient's vasculature can improve the patient's disease and quality of life.

[0005] Mechanical thrombectomy devices can be particularly advantageous. There is a clear need for thrombectomy devices, particularly those that can be easily and precisely delivered through the often tortuous anatomy of the peripheral and central vasculature and then reliably deployed to remove thrombotic material. Furthermore, there is a need for devices that are easy and intuitive to operate.

[0006] Finally, there is a clear need for a mechanical thrombectomy device that has a low profile yet can be inserted into relatively large diameter vessels. Described herein are devices (devices, systems and kits) and methods of using them that can address the needs and problems discussed above. Summary of the Invention

[0007] Described herein are mechanical thrombus removal devices (e.g., devices, systems) and methods of using and manufacturing them. These devices may also be referred to as everting mechanical thrombus removal devices and / or everting tube thrombus removal devices. In particular, described herein are everting tube thrombus removal devices that can be deployed within even very large vessels to efficiently capture one or more large thrombi. For example, the devices described herein can be configured to provide high retraction efficiency using flexible tubing (e.g., tractor tubes) to capture and remove even long, large-diameter thrombi, e.g., greater than 10 mm in length and / or greater than 5 mm in diameter, within a catheter with a small or much smaller diameter (e.g., 5 mm, 4 mm, 3 mm, 2 mm, etc.). In some embodiments, the flexible tubing can be longer than five times the length of the thrombus (e.g., alternatively requiring a tractor tube that is six, seven, or eight times longer).

[0008] In particular, described herein is a device that can include an expandable funnel at the end of an everting support catheter around which a flexible tube (e.g., a tractor tube or simply a tractor) is everted. The flexible tube can be a braided or woven material. The flexible tube can generally have a first end coupled to the distal end region of a puller (e.g., an elongated wire, tube, cannula, etc.), and the flexible tube is everted at the distal end of the everting support catheter with the funnel, with the outer portion of the flexible tube extending proximally over the everting support catheter. As the inner (everted) portion of the flexible tube is retracted into the funnel, it compresses a thrombus held (e.g., grasped) by the flexible tube and removes fluid from the thrombus. The everted flexible tube is retracted into the everting support catheter until the entire thrombus is captured, compressed, and retracted into the outer catheter. The device configuration described herein is particularly suited to grasping and removing thrombus, particularly large-diameter thrombus, by using an everting support catheter that includes an expandable funnel at its distal end. The collapsible / expandable funnel can be configured to activate with a compressive force applied by pulling the flexible tube into the everting support catheter, causing the flexible tube to evertate into the everting support catheter and capture the thrombus. The collapsible / expandable funnel can be configured to assume a fully expanded, locked (e.g., "packed") configuration when the flexible tube applies a lateral compressive force to the distal end face of the funnel. Furthermore, the funnel can include openings (described herein as having a porous structure) that allow fluid squeezed out of the thrombus to exit laterally from the funnel as the thrombus moves into the narrower diameter lumen of the everting support catheter and compresses the thrombus. For example, openings through the collapsible / expandable funnel (sometimes referred to herein simply as an expandable funnel) that allow fluid to exit laterally from the funnel wall when the thrombus is compressed can also prevent clogging or clogging of the thrombus.

[0009] Generally, any of the devices (e.g., systems) described herein can include an everting support catheter having an elongate, flexible body with an expandable funnel at the distal end of the elongate, flexible body, with at least a portion of the expandable funnel, e.g., at the proximal end of the expandable funnel adjacent the elongate, flexible body, including an opening for passing fluid from the thrombus laterally through the funnel wall (e.g., the funnel can be porous or partially porous). The device can also include a flexible tube (e.g., a "tractor"). The tractor can be woven or braided. In some embodiments, the device includes a puller within the lumen of the everting support catheter, with a first region of the puller at or near the distal end attached to the flexible tube. A second region of the flexible tube can extend over the exterior surface of the elongate, flexible body. The system is configured such that when the flexible tube is everted over the distal end of the expandable funnel by pulling the flexible tube proximally into the everting support catheter (e.g., by pulling a puller or by pulling a first end of the flexible tube), the funnel can fully expand to a locked (packed) configuration, causing the flexible tube to evert around (roll) over the open distal end (e.g., distal edge) of the expandable funnel. This rolling motion of the flexible tube, similar to the structure of the flexible tube (e.g., a woven structure, a knitted structure, etc.), can capture and draw a thrombus into the lumen of the everting support catheter, compressing the thrombus and removing fluid from the thrombus as it is drawn into the lumen. The first region of the flexible tube can be an end region of the flexible tube. The second end region of the flexible tube can be an end region.

[0010] In any of these devices, a delivery catheter (also referred to herein as an intermediate catheter) can be used to assist in deploying the everting support catheter and flexible tubing assembly in the area of ​​the vasculature containing one or more thrombi to be removed. For example, the system can include an intermediate catheter; an everting support catheter within the intermediate catheter, the everting support catheter having an elongate flexible body, the everting support catheter having an expandable funnel at a distal end of the elongate flexible body, the expandable funnel having a porous region at a proximal end of the expandable funnel adjacent to the elongate flexible body; a puller within the lumen of the everting support catheter; and a woven flexible tube having a first region attached to the puller within the everting support catheter and a second region extending on an outer surface of the elongate flexible body, the flexible tube everting at the distal end of the expandable funnel, and further configured such that the flexible tube can be retracted proximally into the everting support catheter by pulling the puller proximally, and the second region everting around and around the distal end of the expandable funnel as the flexible tube is retracted into the everting support catheter.

[0011] Any of these systems may have an inner diameter of the second region of the flexible tubing extending over the outer diameter of the elongate flexible body that is greater than the maximum outer diameter of the expandable funnel in the expanded configuration. Any of these claimed systems may have a base region of the expandable funnel adjacent the distal end of the elongate flexible body that is porous. For example, the expandable funnel may include a circumferential porous region at the base of the expandable funnel adjacent the distal end of the elongate flexible body.

[0012] In any of these systems, the collapsed configuration can have a maximum outer diameter that is less than about 0.3 times the outer diameter of the elongate flexible body and / or a maximum outer diameter that is less than about 8 mm.

[0013] The expanded configuration can have a minimum outer diameter that is greater than about twice the outer diameter of the elongate flexible body, for example, the expanded configuration can have an outer diameter of from about 2 mm to about 26 mm.

[0014] In any of the systems described herein, the flexible tube can include a braided tube. In some embodiments, the flexible tube can be formed of a woven material or a sheet of material (e.g., laser cut). The tube can be formed from strands or filaments (e.g., monofilament or multifilament). For example, the flexible tube can include a braided tube having more than 10 loops per cross-section of the braided tube along the longitudinal axis of the braided tube.

[0015] In general, the expandable funnel can be formed from a sheet, woven, braided, and / or knitted material and can include one or more supports (arms, struts, etc.). For example, the expandable funnel can be a mesh that inverts upon itself at the distal end of the expandable funnel.

[0016] In some embodiments, the expandable funnel includes a plurality of longitudinal tines contiguous with the elongate flexible body. The expandable funnel may be self-expanding (e.g., biased to at least partially open), or alternatively or additionally, the expandable funnel may be configured to expand when the first region of the flexible tubing is pulled proximally. In some embodiments, the expandable funnel may be configured to self-expand and to achieve a self-expanded configuration in an unconstrained configuration.

[0017] Generally, the expandable funnel is integrated with and forms part of the remainder of the everting support catheter. As such, the interior of the expandable funnel is typically in fluid communication with the lumen of the remainder of the catheter, which may include the interior of the funnel. Similarly, the exterior surface of the catheter body includes and encompasses the exterior surface of the expandable funnel, unless the context dictates otherwise.

[0018] Any of these devices can include a lubricious sleeve covering at least a portion of the expandable funnel. For example, the lubricious sleeve can cover the interior distal end region of the expandable funnel. In some embodiments, the lubricious sleeve extends over the distal end of the funnel. In some embodiments, the lubricious sleeve includes one or more openings, which are located in the proximal portion (e.g., near the base of the expandable funnel).

[0019] Generally, the expandable funnel may be any suitable size in the expanded configuration, e.g., having a maximum outer diameter of 2 to 26 mm. For example, the expandable funnel may have a maximum outer diameter greater than 16 mm (e.g., greater than about 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, 20 mm, etc.) in the expanded configuration. A user may generally select an eversion support catheter having a maximum size within a range of about 60% (e.g., about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, etc.) or more of the inner diameter of the vessel in which the device will be used (e.g., alternatively or additionally, the outer diameter of the thrombus to be removed).

[0020] Any of the devices (e.g., systems) described herein can include an intermediate catheter at least partially surrounding the everting support catheter and / or a puller within the lumen of the everting support catheter. For example, the second end of the flexible tube is coupled to a distal end region of the puller. The first region is coupled to the puller proximal to the distal end region.

[0021] Generally, the expandable funnels described herein can be configured to withstand a tensile force sufficient to evertate a flexible tube around itself, draw a thrombus (even a very large diameter thrombus) into the funnel, compress the thrombus (e.g., remove much of the thrombus's fluid), and draw the compressed thrombus into the everting support catheter body. For example, the expandable funnel can be configured to withstand a compressive force of greater than about 500 g (e.g., greater than about 600 g, greater than about 700 g, greater than about 750 g, greater than about 800 g, greater than about 900 g, greater than about 1000 g, greater than about 1100 g, greater than about 1200 g, greater than about 1300 g, greater than about 1400 g, greater than about 1500 g, etc.) without collapsing when the compressive force is directed axially (e.g., proximally). For example, the expandable funnel can be configured to withstand a compressive force of greater than 1200 g without collapsing. In some embodiments, the compressive force can lock or stack funnels together, particularly when the funnels are made of woven, knitted, or braided material. For example, in the case of woven funnels, the compressive force can axially pack the weave of the funnel material, increasing the braid angle in the distal (wider) regions and increasing the column strength of the funnel.

[0022] For example, a thrombus removal system can include an everting support catheter having an elongated, flexible catheter body, a catheter lumen, and an expandable funnel disposed at the distal end of the catheter body, the distal end of the funnel defining a distal opening communicating with the interior of the funnel and the catheter lumen, respectively; and a flexible tube that is everted at the distal end of the funnel to have a first region disposed at least partially within the interior of the funnel and a second region extending at least partially outside the funnel, the flexible tube configured to be retracted proximally into the catheter lumen by pulling the first region proximally, such that the second region wraps around the distal end of the funnel as the flexible tube is retracted into the catheter lumen.

[0023] In some aspects, a thrombus removal system can include an everting support catheter having an elongate, flexible catheter body, a catheter lumen, and an expandable funnel disposed at a distal end of the catheter body, wherein the distal end of the funnel defines a distal opening communicating with the interior of the funnel and the catheter lumen, respectively, and at least a proximal portion of the funnel adjacent the catheter body includes an opening configured to allow a fluid to pass therethrough; a puller disposed within the catheter lumen; and a flexible tube formed of a braided or woven material, the flexible tube everted at the distal end of the funnel and having a first region coupled to the puller and a second region extending at least partially over an outer surface of the funnel, wherein the flexible tube is configured to be drawn proximally into the catheter lumen by pulling the puller proximally, thereby causing the second region of the flexible tube to pass through the interior of the funnel and into the catheter lumen.

[0024] The thrombus removal system includes an everting support catheter having an elongated flexible catheter body, a catheter lumen, and an expandable funnel disposed at a distal end of the catheter body, the distal end of the funnel defining a distal opening communicating with the interior of the funnel and the catheter lumen, respectively, and at least a proximal portion of the funnel adjacent the catheter body including an opening configured to allow a fluid to pass therethrough; a braided flexible tube having a first region everted at the distal end of the funnel and at least partially disposed within the interior of the funnel, and a second region on an outer surface of the funnel; and a flexible tube having a first region extending partially through the funnel and a second region extending partially through the funnel, the flexible tube configured to be drawn proximally into the catheter lumen by pulling the first region of the flexible tube proximally, the second region of the flexible tube wrapping around the distal end of the funnel as the flexible tube is drawn into the interior of the funnel and into the catheter lumen, respectively, and the funnel configured such that pulling the first region of the flexible tube proximally applies an axial load to the funnel that expands the funnel to a packed configuration.

[0025] Also described herein are methods for removing a blood clot from a blood vessel using any of the devices described herein. For example, a method of removing a thrombus from a blood vessel can include advancing an everting tube device through the blood vessel until a distal end of the everting tube device is adjacent to the thrombus, the everting tube device comprising an everting support catheter having an expandable funnel disposed at a distal end of an elongate flexible body, and a flexible tube having a first region within the everting support catheter and a second region extending on an outer surface of the everting support catheter; expanding the expandable funnel from a collapsed configuration to an expanded configuration within the blood vessel; and pulling the first region of the flexible tube proximally to contort the flexible tube over the distal end of the expandable funnel of the everting support catheter, thereby everting the flexible tube over the distal end of the expandable funnel to capture the thrombus and draw the thrombus proximally into the everting support catheter, wherein drawing the thrombus proximally into the everting support catheter includes compressing the thrombus and expelling fluid from the thrombus laterally out of the everting support catheter.

[0026] For example, a method of removing a thrombus from a blood vessel may include advancing an everting tube device through the blood vessel until a distal end of the everting tube device is positioned adjacent to the thrombus, the everting tube device comprising an everting support catheter having an elongated flexible catheter body, an internal catheter lumen, and an expandable funnel disposed at the distal end of the catheter body, the distal end of the funnel defining openings communicating with the interior of the funnel and the catheter lumen, respectively, the everting tube device everting at the distal end of the expandable funnel; and The method can further include the steps of providing a flexible tube having a first region at least partially disposed inside the funnel and a second region extending at least partially on an outer surface of the funnel, expanding the funnel from a collapsed delivery configuration to an expanded configuration within the blood vessel adjacent to the thrombus, and pulling the first region of the flexible tube proximally to contort the second region of the flexible tube at the distal end of the funnel, whereby the flexible tube captures the thrombus and draws the thrombus proximally into the interior of the funnel and into the catheter lumen.

[0027] Any of the methods for removing a blood clot from a blood vessel described herein can include using any of these devices. For example, a method of removing a thrombus from a blood vessel can include advancing an everting tube device through the blood vessel until a distal end of the everting tube device is adjacent to the thrombus, the everting tube device comprising an everting support catheter having an expandable funnel disposed at a distal end of an elongate flexible body, and a flexible tube having a first region within the everting support catheter and a second region extending on an outer surface of the everting support catheter; expanding the expandable funnel from a collapsed delivery configuration to an expanded configuration within the blood vessel; and pulling the first region of the flexible tube proximally to roll the flexible tube over the distal end of the expandable funnel of the everting support catheter, whereby the flexible tube everts over the distal end of the expandable funnel to capture the thrombus and draw the thrombus proximally into the everting support catheter, wherein drawing the thrombus proximally into the everting support catheter includes compressing the thrombus and expelling fluid from the thrombus laterally out of the everting support catheter.

[0028] Any of these methods may include selecting the size of the everting tube device based on the size of the vessel, as described above, so that the user can select from a variety of different sizes of intermediate catheter and / or flexible tube based on the size of the vessel and / or thrombus.

[0029] In any of these methods, expanding can include expanding the expandable funnel to an outer diameter at least one-third greater than the outer diameter of the thrombus (e.g., an outer diameter greater than 33%, greater than 40%, greater than 50%, greater than 60%, greater than 70%, greater than 80%, greater than 90% of the OD of the thrombus and / or ID of the vessel, etc.). For example, expanding can include expanding the expandable funnel to an outer diameter at least 50% greater than the outer diameter of the thrombus.

[0030] In some embodiments, pulling the thrombus proximally can include applying a force of between 500 g and 3000 g.

[0031] In some embodiments, expanding the expandable funnel includes allowing the expandable funnel to self-expand within the blood vessel and / or expanding the expandable funnel can include applying an axial compressive force to the expandable funnel by pulling a first region of the flexible tubing proximally. The self-expandable funnel can be further expanded by pulling the flexible tubing proximally to apply an axial compressive force to the expandable funnel. For example, in some embodiments, the expandable funnel can be configured to self-expand to a self-expanded configuration when unconstrained, e.g., when released from a constrained configuration within a second catheter (e.g., a guide catheter, an intermediate catheter, etc.).

[0032] Any of these methods may include removing the flexible tubing from within the everting support catheter and reloading a new flexible tubing into the everting support catheter.

[0033] For example, systems described herein include thrombus removal systems, any of which may include an everting support catheter having an elongate, flexible body with an expandable funnel at a distal end of the elongate, flexible body, and a flexible tube having a first region within the everting support catheter and a second region extending on an outer surface of the elongate, flexible body, the flexible tube everting at the distal end of the expandable funnel, and further configured such that the flexible tube can be retracted proximally into the everting support catheter by pulling the first region proximally, and the second region everting around the distal end of the expandable funnel as the flexible tube is retracted into the everting support catheter.

[0034] Any of these systems may include an everting support catheter having an elongate, flexible body and an expandable funnel at a distal end of the elongate, flexible body, wherein at least a proximal end of the expandable funnel adjacent to the elongate, flexible body includes an opening configured to allow a fluid to pass therethrough; a puller disposed within the lumen of the everting support catheter; and a flexible tube formed of a braided or woven material, the flexible tube having a first region connected to the puller within the everting support catheter and a second region extending on an outer surface of the elongate, flexible body, wherein the flexible tube everts at the distal end of the expandable funnel and further wherein the flexible tube is configured to be retracted proximally into the everting support catheter by pulling the puller proximally, such that the flexible tube everts around and around the distal end of the expandable funnel as it is retracted into the everting support catheter.

[0035] For example, the system can include an everting support catheter having an elongate, flexible body and an expandable funnel at a distal end of the elongate, flexible body, wherein at least a proximal end of the expandable funnel adjacent the elongate, flexible body includes an opening configured to allow a fluid to pass therethrough; a puller within the lumen of the everting support catheter; and a braided flexible tube having a first region within the everting support catheter connected to the puller and a second region extending on an outer surface of the elongate, flexible body, wherein the flexible tube everts at the distal end of the expandable funnel and is further configured such that the flexible tube can be retracted proximally into the everting support catheter by pulling the puller proximally, and as it is retracted into the everting support catheter, the flexible tube everts around and around the distal end of the expandable funnel, thereby applying an axial load to the funnel and causing it to expand into an expanded configuration.

[0036] In any of these systems, the inner diameter of the second region of the flexible tubing that extends over the outer diameter of the elongate flexible body may be smaller than the maximum outer diameter of the expandable funnel in the expanded configuration. Thus, the flexible tubing may be expanded when pulled over the funnel portion of the everting support catheter from a smaller, relaxed diameter on the more proximal body of the everting support catheter. In any of the devices described herein, the flexible tubing may be biased to have an outer diameter that is 40% or more larger (e.g., 50% or more, 60% or more, 70% or more, 75% or more, or 80% or more larger) than the inner diameter of the elongate body of the everting support catheter so that the everting portion (while in the everting support catheter) is self-expanding (or configured to expand).

[0037] As discussed above, the base region of the expandable funnel adjacent the distal end of the elongate flexible body can include openings (e.g., sometimes referred to as porous) configured to allow fluid to pass therethrough. In some embodiments, the openings or pores can be formed by openings between one or more strands that form the woven funnel body. For example, the expandable funnel can include a circumferential porous region at the base of the expandable funnel adjacent the distal end of the elongate flexible body.

[0038] The collapsed configuration of the expandable funnel can have a maximum outer diameter that is less than 0.3 times (e.g., 30%) the outer diameter of the elongate, flexible body. In some versions, the collapsed configuration may be configured to collapse the distal end of the expandable funnel to 30% or less, 40% or less, 50% or less, 60% or less, 70% or less, 75% or less, 80% or less, etc., of the outer diameter of the elongate, flexible body of the everting support catheter (e.g., the average outer diameter, or the region of the everting support catheter proximal to the funnel). In some embodiments, the collapsed configuration has a maximum outer diameter of less than 8 mm.

[0039] In some embodiments, the expanded configuration can have a minimum outer diameter that is more than twice (e.g., more than 2.5 times, more than 3 times, more than 3.5 times, etc.) the outer diameter of the elongate, flexible body. The maximum outer diameter is typically the diameter of the distal face of the funnel, which may also be referred to as the distal opening or distal edge. For example, the expanded configuration can have an outer diameter of 2 to 26 mm.

[0040] As noted above, the flexible tube generally can include a braided tube, for example, the flexible tube can be configured as a braided tube having more than 10 loops per cross-section of the braided tube along the longitudinal axis of the braided tube.

[0041] As described in more detail below, the expandable funnel can include a plurality of longitudinal tines (e.g., struts) continuous with the elongated flexible body. The tines can extend distally (e.g., longitudinally) and can be covered, for example, by a mesh material (e.g., a woven or knitted material in some embodiments) folded over itself to form an inner surface within the mouth of the funnel and an outer surface outside the funnel. The tines can be inserted between the inner and outer surfaces and can move longitudinally relative to the inner and outer surfaces. For example, the expandable funnel can include a mesh that is inverted over itself at the distal end of the expandable funnel.

[0042] Generally, the expandable funnel may be biased to at least partially self-expand, hi some embodiments, the expandable funnel is configured to fully expand when the first region of the flexible tubing is pulled proximally.

[0043] In any of the devices described herein, the lubricious sleeve can cover at least a portion of the expandable funnel, for example, can cover the inner and / or outer surfaces and / or can cover the everting distal end region.

[0044] The funnel can be configured to open to any suitable diameter, for example, in some embodiments, the expandable funnel can have a maximum outer diameter of greater than 16 mm.

[0045] Any of the devices described herein can include a puller (rod, catheter, wire, etc.) within the lumen of the everting support catheter, with the second end of the flexible tubing coupled to a distal end region of the puller, and in some embodiments, the first region of the flexible tubing attached proximally to the distal end of the puller.

[0046] In some embodiments, the thrombus removal device can include an everting support catheter having an expandable funnel at the distal end of a flexible elongate body, the expandable funnel including a funnel surface formed by a first tube of braided or woven material that everts onto itself to form inner and outer funnel surfaces, a plurality of support tines extending distally between the inner and outer funnel surfaces, the funnel surface configured to slide axially relative to the plurality of support tines, and a second flexible tube of braided or woven material extending distally along the outer surface of the catheter body and everting into the interior of the expandable funnel and into the lumen of the everting support catheter, the expandable funnel configured to expand into a stowed configuration when the second flexible tube is retracted proximally into the everting support catheter. As described above, the funnel surface can include a woven material. In some embodiments, the funnel surface has a braid angle greater than 90 degrees in the stowed configuration.

[0047] That is, in some embodiments of the expandable funnels described herein, the expandable funnel can be configured to assume a packed configuration when an axial compressive force is applied, for example, by pulling a tractor (e.g., a flexible tube) proximally so that the tractor is everted on the funnel from outside the everting support catheter and into the lumen of the everting support catheter. The packed configuration can result in a stiffer, compressed configuration than the unpacked configuration of the expandable funnel. The packed configuration also has greater column strength. In embodiments in which the walls of the expandable funnel are formed from a woven material, the packed configuration is provided by a weave having a maximum braid angle, also referred to as the packed angle.

[0048] As described above, the tines may be formed (e.g., cut, such as by laser cutting) from a flexible, elongated body. The expandable funnel may also include one or more circumferential supports extending radially around the funnel surface and constraining the outer diameter of the expandable funnel. The one or more circumferential supports may include one or more filaments, such as yarn, wire, suture, and thread. For example, the one or more circumferential supports may include suture material. The one or more circumferential supports may connect the inner and outer funnel surfaces. The one or more circumferential supports may extend helically around the expandable funnel as a single filament, or in some cases as multiple filaments.

[0049] In some embodiments, the tines may be folded back on themselves and crimped together. In some embodiments, each tine is connected by a filament, for example, at the distal end region. This filament may be referred to as a tine filament and may distribute force among the different tines. Multiple different tine filaments may be used. In some embodiments, the tine filament may be secured to the tine near the distal end of the tine (e.g., within 1 mm, 2 mm, 3 mm, etc.) from the distal-facing end of the tine. In some embodiments, one or more tine filaments are secured within a cavity formed by the folded back portion of the tine.

[0050] In any of the expandable funnels described herein, the funnel surface may extend a relatively short distance from the distal ends of the tines when the funnel is in a packed, expanded configuration. For example, the mesh forming the outer and inner surfaces may be secured to one another but not to the tines, and the mesh may extend distally from the tines in the expanded configuration more than 5 mm or less (e.g., 4 mm or less, 3 mm or less, 2 mm or less, 1 mm or less, etc.) from the distal ends of the tines when the expandable funnel is expanded to the packed configuration. For example, the funnel surface may extend 1 mm or less from the distal ends of the tines when the expandable funnel is expanded to the packed configuration.

[0051] As described above, the second flexible tube can be formed of a braided material. Additionally, any of the devices described herein can include a puller extending through the everting support catheter and coupled at a distal end to the first end of the second flexible tube. The surface of the funnel can be shaped such that the inner surface has an outer diameter that is smaller than the inner diameter of the outer surface to form a space for the multiple tines between the inner and outer surfaces.

[0052] For example, a thrombus removal device described herein includes an everting support catheter having an expandable funnel at the distal end of a flexible, elongate body, the expandable funnel including a funnel surface formed by a first tube of woven material that everts onto itself to form inner and outer funnel surfaces, a plurality of support tines extending distally between the inner and outer funnel surfaces, the funnel surface configured to slide axially relative to the plurality of support tines, one or more circumferential supports extending radially around the funnel surface to constrain the maximum outer diameter of the expandable funnel, and a second flexible tube made of braided or woven material extending distally along the outer surface of the everting support catheter and everting with the expandable funnel into the interior of the funnel and into the lumen of the everting support catheter when a first end of the second flexible tube is retracted proximally into the everting support catheter.

[0053] The thrombus removal device can include an everting support catheter having an expandable funnel at the distal end of a flexible, elongate body, the expandable funnel including: a funnel surface formed by a first tube made of a woven material that everts onto itself to form inner and outer funnel surfaces; a plurality of support tines extending distally between the inner and outer funnel surfaces, the funnel surface configured to slide axially relative to the plurality of support tines; one or more circumferential supports extending radially around the funnel surface to constrain the maximum outer diameter of the expandable funnel and connect the inner and outer funnel surfaces; and a second flexible tube made of a braided or woven material that extends distally along the outer surface of the everting support catheter and everts with the expandable funnel into the interior of the funnel and into the lumen of the everting support catheter when a first end of the second flexible tube is retracted proximally into the everting support catheter.

[0054] In some embodiments, a thrombus removal device can include an everting support catheter having an expandable funnel at the distal end of a flexible, elongated catheter body, the funnel comprising a first flexible tube made of a braided or woven material everted upon itself to form inner and outer funnel surfaces, the inner funnel surface defining an interior of the funnel that communicates with a catheter lumen extending through the catheter body, and a plurality of support ties extending distally from the distal end of the catheter body between the inner and outer funnel surfaces. the funnel includes a plurality of support tines, each of which has an inner funnel surface and an outer funnel surface configured to slide axially relative to the support tines; and a second flexible tube made of a braided or woven material extending distally along at least a portion of the outer surface of the catheter body and the outer funnel surface, respectively, and inverting into the interior of the funnel and into the catheter lumen at the distal end of the funnel, the funnel configured to expand to a packed configuration when the second flexible tube is pulled proximally into the catheter lumen.

[0055] The devices described herein can be configured as kits or systems for performing thrombectomy procedures and can be packaged together, including pre-loaded components, or sold separately. For example, a thrombectomy system described herein can include an everting support catheter having an elongate, flexible body and an expandable funnel at a distal end of the elongate, flexible body, a flexible tube made of a braided or woven material extending distally along the exterior surface of the everting support catheter and configured to evert with the expandable funnel into the interior of the funnel and into the lumen of the everting support catheter to expand the expandable funnel, and a tear-away sleeve extending over the flexible tube and everting support catheter, the tear-away sleeve configured to be removed from over the flexible tube by tearing along the length of the tear-away sleeve when the everting support catheter and flexible tube are loaded into a delivery catheter.

[0056] The thrombus removal system can include an everting support catheter having an elongated flexible body and an expandable funnel at the distal end of the elongated flexible body, a flexible tube made of a braided or woven material extending distally along the outer surface of the everting support catheter and configured to evert with the expandable funnel into the interior of the funnel and into the lumen of the everting support catheter to expand the expandable funnel, and a loading sleeve, wherein the distal end of the everting support catheter is loaded into the loading sleeve such that the funnel is restrained in a collapsed configuration, and further wherein the loading sleeve includes a tear line configured to disassemble the loading sleeve to remove the loading sleeve from the everting support catheter.

[0057] In some aspects, the thrombus removal system can include an everting support catheter having an elongate flexible body and an expandable funnel at a distal end of the elongate flexible body; a flexible tube made of braided material extending distally along an outer surface of the everting support catheter and configured to evert with the expandable funnel into the interior of the funnel and into the lumen of the everting support catheter to expand the expandable funnel; a loading sleeve into which the distal end of the everting support catheter is loaded such that the expandable funnel is restrained in a collapsed configuration, the loading sleeve further comprising a tear line configured to disassemble the loading sleeve to remove the loading sleeve from the everting support catheter; and a tear sleeve extending over the flexible tubing and the everting support catheter, the tear sleeve configured to be removed from over the flexible tubing by tearing along the length of the tear sleeve as the everting support catheter and flexible tubing are loaded into the delivery catheter.

[0058] Thus, any of the systems described herein can include a loading sleeve, and the distal end of the everting support catheter is loaded into the loading sleeve such that the expandable funnel is restrained in a collapsed configuration.

[0059] Any of these systems can include a delivery catheter, with the loading sleeve configured to be inserted into the proximal end of the delivery catheter such that the everting support catheter and flexible tube of braided or woven material are driven distally within the delivery catheter.

[0060] Additionally, any of these systems may include a second flexible tube made of a braided or woven material configured to be inserted into the everting support catheter. Thus, the system may be configured to allow deployment (e.g., with a loading sleeve) of the second flexible tube configured for at least partial insertion into the everting support catheter, for example, by a physician, nurse, medical technician, etc.

[0061] Any of the everting support catheters described herein can include a stopper at the proximal end region of the everting support catheter that is configured to prevent the flexible tubing, which is made of a braided or woven material, from extending proximally beyond the stopper and onto the exterior surface of the everting support catheter. This can be particularly useful when the flexible tubing is loaded (e.g., by a user) onto the everting support catheter and inserted into the delivery catheter, which may include a tear-away sleeve that prevents the flexible tubing (e.g., a braided tubing) from being pushed proximally when the everting support catheter and flexible tubing are pushed distally into the delivery catheter.

[0062] In some embodiments, the flexible tube may include an elastic cuff at the proximal end of the flexible tube, which may be made of a braided or woven material, that interacts with (e.g., engages with) the stopper of the everting support catheter to prevent it from extending beyond the stopper.

[0063] As previously mentioned, the system may include a puller within the everting support catheter to which is coupled the distal end of a flexible tube of braided or woven material.

[0064] In some aspects, the system can include a lock configured to secure the everting support catheter to the delivery catheter, the lock can engage both the delivery catheter and the everting support catheter, allowing them to be moved together, for example, with one hand.

[0065] The thrombus removal system includes an everting support catheter having an elongated flexible catheter body, a catheter lumen, and an expandable funnel disposed at a distal end of the catheter body, the distal end of the funnel defining openings communicating with the interior of the funnel and the catheter lumen, respectively; a first flexible tube made of a braided or woven material extending distally along at least a portion of an outer surface of the catheter body and an outer surface of the funnel, at least a portion of the first flexible tube everting into the interior of the funnel and the catheter lumen at the distal end of the funnel; and a tear-away sleeve extending over at least a distal portion of the first flexible tube and the everting support catheter, the tear-away sleeve configured to be removed from over the first flexible tube by tearing along the length of the tear-away sleeve when the everting support catheter and first flexible tube are loaded into a delivery catheter.

[0066] For example, the thrombus removal system may include an everting support catheter having an elongated, flexible catheter body, a catheter lumen, and an expandable funnel disposed at a distal end of the catheter body, the distal end of the funnel defining openings communicating with the interior of the funnel and the catheter lumen, respectively; a first flexible tube made of a braided or woven material extending distally along at least a portion of an outer surface of the catheter body and an outer surface of the funnel, at least a portion of the first flexible tube everting into the interior of the funnel and the catheter lumen at the distal end of the funnel; and a loading sleeve, wherein a distal portion of the everting support catheter is loaded into the loading sleeve with the funnel restrained in a collapsed configuration, the loading sleeve including a tear line configured to disassemble and remove the loading sleeve from over the everting support catheter.

[0067] While an everting support catheter with an expandable funnel as described herein can be included as part of a device for performing thrombectomy (or in some embodiments atherectomy), any of these everting support catheters can find use by itself, without other components of the system (e.g., flexible tubing). For example, described herein is a support catheter having an expandable funnel at the distal end of a flexible elongate body, the expandable funnel comprising a funnel surface formed by a first tube of braided or woven material that everts onto itself to form inner and outer funnel surfaces, and a plurality of support tines extending distally between the inner and outer funnel surfaces, the funnel surface configured to slide axially relative to the plurality of support tines.

[0068] As noted above, also described herein are methods for performing atherectomy to remove atheroma using any of the devices described herein. Generally, the everting tube device can include or be used in combination with one or more ring cutters, such as a ring stripper or a dual ring cutter (e.g., a MollRing cutter), which are used to cut the core of the atheroma, after which a stent can be inserted.

[0069] For example, a method of atheroma removal described herein includes the steps of: advancing an everting tube device through a blood vessel until a distal end of the everting tube device is proximate to an atheroma, the everting tube device comprising: an everting support catheter having an expandable funnel at the distal end of an elongate, flexible body, the expandable funnel having a collapsed configuration and an expanded configuration; and a flexible tube having a first region within the everting support catheter and a second region extending on an outer surface of the everting support catheter; expanding the expandable funnel from the collapsed configuration to an expanded configuration within the blood vessel proximate to the atheroma; while advancing the everting tube device distally, pulling the first region of the flexible tube proximally to convolve the flexible tube over the distal end of the expandable funnel of the everting support catheter, thereby everting the flexible tube over the distal end of the expandable funnel; and applying an axial shear force from the moving flexible tube to the wall to excise the atheroma from the blood vessel.

[0070] Applying an axial shear force can further include ablating the atheroma with a plurality of protrusions extending from the flexible tube.

[0071] Any of these methods can further include advancing a ring cutter (or dual ring cutter / stripper) over the everting tube device into the atheroma after the everting tube device engages the atheroma, and can further include retracting the second ring cutter proximally to cut the atheroma with the second ring cutter in a direction transverse to the longitudinal axis of the blood vessel.

[0072] For example, the apparatus (e.g., systems, devices, etc.) and methods described herein can also be adapted for removing atheromatous material, including performing atherectomy. A device such as that described herein configured as an atherectomy device can include an everting support catheter having an elongated, flexible body and an expandable funnel (having a collapsed configuration and an expanded configuration) at the distal end of the elongated, flexible body; a flexible tube having a first region within the everting support catheter and a second region extending on the outer surface of the elongated, flexible body; the flexible tube everting at the distal end of the expandable funnel; and the flexible tube being configured to be retracted proximally into the everting support catheter by pulling the first region proximally, such that the second region wraps around and inverts at the distal end of the expandable funnel as the flexible tube is retracted into the everting support catheter. The flexible tube can include atheroma-capturing or cutting protrusions extending from the flexible tube as the flexible tube wraps around the funnel. For example, protrusions can extend from the flexible tube to engage the atheroma as the flexible tube moves along the outer, angled side of the funnel. In some embodiments, the flexible tube can reciprocate in and out of the expandable funnel to cut and / or remove the atheroma. [Brief explanation of the drawings]

[0073] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings. [Figure 1] 1A-1C show an example of a mechanical everting tube device that is particularly well-suited for use in small, tortuous vascular anatomy. In FIG. 1A, the assembled device is shown in a side view, illustrating the everting support catheter and flexible outer tube. FIG. 1B shows the everting tube device of FIG. 1A within a blood vessel adjacent to a thrombus. FIG. 1C shows how the device of FIG. 1A can be used to remove a thrombus from a blood vessel by pulling the flexible tube on the outside of the everting support catheter proximally, causing the flexible tube to wrap around the distal end of the everting support catheter and into the everting support catheter, pulling the thrombus with the flexible tube. The device can be advanced distally. [Figure 2] Figure 2 shows an example of an everting tube device similar to that shown in Figure 1A in a large vessel containing a thrombus with a diameter greater than twice the inner diameter of the everting support catheter. While an everting tube device with a smaller diameter everting support catheter can capture and remove the thrombus, the efficiency of everting is low, requiring, for example, flexible tubing approximately 12 times the length of the everting tube to capture the entire thrombus. [Figure 3A] 3A shows an example of an everting tube device configured to dehydrate (e.g., remove fluid) from a thrombus as it is entrapped, improving the efficiency of eversion. In FIG. 3A, the everting tube device is shown in an undeployed state within an intermediate (e.g., delivery) catheter, where the everting support catheter includes an expandable funnel at the distal end around which the flexible tube everts. The flexible tube is attached to the distal end region of the puller such that the puller extends distally. [Figure 3B]3B shows an example of an everting tube device configured to dehydrate (e.g., remove fluid) from the thrombus as it is entrapped, improving the efficiency of eversion. In FIG. 3B, the everting tube device of FIG. 3A is shown in a deployed configuration with at least the distal end extending from the intermediate catheter, and the expandable funnel at the distal end of the everting support catheter is in an expanded configuration. [Figure 4A] 10 shows another example of an everting tube device including an expandable funnel, where a flexible tube (e.g., a braided tube) is attached to the distal end of a puller. [Figure 4B] Figure 4B shows another example of an everting tube device including an expandable funnel, where a flexible tube (e.g., a braided tube) is attached to the distal end of a puller. Figure 4B shows the everting tube device of Figure 4A in a deployed configuration, with the intermediate (e.g., delivery) catheter retracted proximally, allowing the expandable funnel at the distal end of the everting support catheter to expand and the flexible tube to expand. [Figure 4C] 4A-4C are images of a prototype everted tube device similar to that shown in FIGS. [Figure 5A] FIG. 10 is a top perspective view showing an example of the distal end of an everting tube device that includes a funnel at the distal end of an everting support catheter around which a braided flexible tube is everted. [Figure 5B] FIG. 10 is a side view showing an example of the distal end of an everting tube device that includes a funnel at the distal end of an everting support catheter around which a braided flexible tube is everted. [Figure 6A] Figure 6 shows an example of a prototype everting support catheter that includes an expandable funnel at its distal end, which can be used with an everting tube device. Figure 6A shows the expandable funnel in its collapsed configuration. [Figure 6B]Figure 6B shows an example of a prototype everting support catheter that includes an expandable funnel at its distal end, which can be used with an everting tube device. Figure 6B shows the expandable funnel deployed (e.g., from an intermediate catheter or delivery catheter, not shown). [Figure 6C] Figure 6C shows an example of a prototype everting support catheter that includes an expandable funnel at its distal end, which can be used with an everting tube device. Figure 6C shows the expandable funnel fully deployed by applying a compressive force along the long axis of the everting support tube. [Figure 6D] Figure 6D shows an example of a prototype everting support catheter that includes an expandable funnel at its distal end, which can be used with an everting tube device. Figure 6D shows an example of an everting tube device that includes an everting support catheter with an expandable funnel, as shown in Figures 6A-6C. [Figure 7A] 7A and 7B show an example of an everting tube device configured to dehydrate a clot while capturing the clot. In Fig. 7A, the everting tube device is shown next to a 4 mm clot prior to capturing the clot. [Figure 7B] 10 shows the everting tube device after thrombus has been entrapped, with the flexible tube removed from the everting support catheter with the expandable funnel. [Figure 8A] 1 shows an example of an everting tube device in which the inner diameter of the flexible tube is selected to match the outer diameter of the thrombus before the everting tube device entraps the thrombus. [Figure 8B] 1 shows the thrombus after it has been captured (entrapped) by the flexible tube of the everting tube device. [Figure 9]Figures 9A-9C show the relationship between thrombus efficiency (e.g., the length of flexible tubing required to aspirate and remove a thrombus) and demonstrate that thrombus efficiency improves with larger outer diameter flexible tubing. Figure 9A shows an example of an everting tube device for aspirating a thrombus within a blood vessel. Figure 9B is a graph showing the length of flexible tubing (braided flexible tubing) required to capture a 5 cm thrombus with an outer diameter (OD) of 15 mm into an everting support catheter with an inner diameter (ID) of 8F (e.g., less than 2.67 mm). Figure 9C shows examples of various everting tube devices with different flexible tubing ODs. [Figure 10A] 1 shows an example of an everting support catheter with an expandable funnel at its distal end. [Figure 10B] 1 shows an example of an everting support catheter with an expandable funnel at its distal end. [Figure 10C] 1 shows an example of an everting support catheter with an expandable funnel at its distal end. [Figure 10D] 1 shows an example of an everting support catheter with an expandable funnel at its distal end. [Figure 11] 11A-11D show an example of an everting support catheter having an expandable funnel. FIG. 11A is a schematic diagram of an everting support catheter having a funnel including a support frame formed from the distal end region of an elongated everting support catheter. FIG. 11B shows an example of an everting support catheter cut to form the support shown schematically in FIG. 11A. FIG. 11C shows an example of a distal funnel of an everting support catheter formed by braided material attached to a frame such as the frame shown in FIG. 11B. FIG. 11D is an end view of the funnel shown in FIG. 11C. [Figure 12]12 shows an example of a funnel of an everting support catheter configured with sufficient axial compressive strength to resist collapse when subjected to an axial compressive force of greater than 500 g (e.g., greater than 1 kg, greater than 1.2 kg, greater than 1.5 kg). In this example, an axial compressive force applied by drawing (e.g., pulling) a flexible tube proximally around the distal end of the funnel can also open and deploy the funnel. [Figure 13] 13A-13D show an example of an everting support catheter having an expandable funnel lined with a lubricious (e.g., Teflon) sleeve. FIG. 13A is a schematic diagram of an everting support catheter including a funnel comprising a support frame formed from the distal end region of an elongated everting support catheter and a lubricious sleeve. FIG. 13B shows an example of an everting support catheter as shown schematically in FIG. 13A, including a lubricious sleeve. FIG. 13C shows an example of a distal funnel of an everting support catheter as shown schematically in FIG. 13B, shown in an expanded configuration. FIG. 13D is an end view of the funnel shown in FIG. 13C. [Figure 14] 14A-14C show an example of an expandable funnel of an everting support catheter that can include a lubricious sleeve in the mouth of the funnel to reduce pulling forces. [Figure 15A] An example of a frame cut to form a funnel at the distal end of an everting support catheter. In FIG. 15A, the fingers formed by cutting the distal end of the catheter are covered with a PTFE membrane in the mouth of the funnel. [Figure 15B] FIG. 10 is an example of a frame cut to form a funnel at the distal end of an eversion support catheter, with curved struts (fingers) forming the funnel region. [Figure 16-1] 10 shows an example of a clot removal device having different sizes that a user can select based on the size of the vessel and / or clot. [Figure 16-2] 10 shows an example of a clot removal device having different sizes that a user can select based on the size of the vessel and / or clot. [Figure 17A] 1 shows an example of an everting tube device used to remove atheroma (eg, atherectomy). [Figure 17B] 1 shows an example of an everting tube device used to remove atheroma (eg, atherectomy). [Figure 17C] 1 shows an example of an everting tube device used to remove atheroma (eg, atherectomy). [Figure 18] 18A-18C show an example of a method for removing atheroma using an everting tube device and a pair of cutting rings. [Figure 19] FIG. 19 shows an example of a portion of the distal end of an eversion support catheter that includes multiple tines. [Figure 20A] 1 illustrates an example of multiple tines of an everting support catheter having an expandable funnel with filaments connecting adjacent tines. [Figure 20B] FIG. 20B is a close-up view of the distal end of the tine (filament shown) of FIG. 20A. [Figure 21A] FIG. 1 is an example of a flexible tube made of a woven material that can form the funnel surface of an expandable funnel of an everting support catheter, where the woven material is folded back on itself and shape-set (e.g., heat-set) so that there is space between the outer and inner funnel surfaces for the tines to fit. [Figure 21B] 21B shows an enlarged view of the flexible tube of FIG. 21A. [Figure 22A] 1 is an example of an expandable funnel of an everting support catheter in a relaxed state. [Figure 22B] 22B shows the expandable funnel of FIG. 22A in a fully expanded configuration under compressive stress. [Figure 22C] 22D shows the expandable funnel of FIG. 22C in a collapsed and constrained state within a loading sleeve. [Figure 23] FIG. 23 is another example of an expandable funnel for an eversion support catheter. [Figure 24A]1 shows an example of an expandable funnel for an eversion support catheter having a flexible tube of braided material that extends distally along the exterior of the eversion support catheter and everts into the eversion support catheter. [Figure 24B] FIG. 24A shows the system of FIG. 24A with tension applied to pull the tube of braided or woven material into the everting support catheter, fully expanding and packing the funnel body into the expanded configuration as shown. [Figure 25] FIG. 25 is an example of a system including an everting support catheter having an elongated flexible body and an expandable funnel, a flexible tube of braided material extending distally along the outer surface of the everting support catheter, a loading sleeve and a tear sleeve extending over the flexible tube and the everting support catheter, a pair of locks configured to secure the everting support catheter to a delivery catheter (not shown), and a second flexible tube made of braided or woven material configured to be inserted into the everting support catheter. [Figure 26] FIG. 26 shows an example of a stopper at the proximal end of an everting support catheter and an elastic cuff at the proximal end of a flexible tube of braided or woven material. [Figure 27A] 1 is an example of a lock configured to secure an everting support catheter to a delivery catheter. [Figure 27B] 27B shows the lock of FIG. 27A attached to both the everting support catheter and the delivery catheter. DETAILED DESCRIPTION OF THE INVENTION

[0074] Generally, described herein are everting tube apparatuses (e.g., devices and systems) that are particularly suited for removing larger diameter thrombi and / or atheromas. Each of the everting tube apparatuses can include an everting support catheter having an elongated flexible body with an expandable funnel at the distal end of the body, and a flexible tube that everts around the everting support catheter containing the expandable funnel when the flexible tube is retracted proximally into the everting support catheter. The everting support catheter can be used with or without the flexible tube.

[0075] Previously described mechanical everting tube devices (also referred to as "mechanical thrombectomy devices") have been configured to effectively remove thrombi, as shown in Figures 1A-1C. The devices and methods of using same described herein may be particularly effective for use in the peripheral vasculature, including use with thrombi having relatively large outer diameters (e.g., relative to the maximum inner diameter of the everting support catheter through which the thrombi are retracted).

[0076] For example, FIG. 1A shows an example of an inverted tractor mechanical thrombectomy device 100 (such as those described in U.S. Patent Application Nos. 15 / 496,570 and 15 / 043,996, each of which is incorporated herein by reference in its entirety).

[0077] In FIG. 1B, an inverting tractor mechanical thrombectomy device 100 is shown positioned near a thrombus 109 within a blood vessel. In the deployed configuration, a puller 101 (shown here as a puller microcatheter, although the puller may alternatively be a wire) is held within an elongated everting support catheter 107 such that a flexible tractor tube 103 extends from the end of the puller 101 and expands toward the inner radius of the elongated everting support catheter 107, at a distal end opening 111 of the elongated everting support catheter, where the tractor tube everts over itself and extends proximally over the distal end of the elongated everting support catheter in an everted configuration. As shown in FIG. 1C, pulling the puller proximally causes the tractor tube to evert over the distal end opening of the elongated everting support catheter, rolling (113, 113′) inside out, thereby drawing adjacent thrombus into the elongated everting support catheter as shown.

[0078] The elongated everting support catheter of FIG. 1A is an elongated tube having a distal end with an inner diameter the same size as the proximal length of the everting support catheter. The everting support catheter 107 is shown positioned between a tractor tube (e.g., flexible tubing 103) and a puller 101, which allows the puller to pull the tractor tube proximally by rolling it around (rolling) within the elongated everting support catheter to evert the tractor tube. The portion of the tractor tube that is everted at the distal end of the elongated everting support catheter has an outer diameter larger than the outer diameter of the elongated everting support catheter. The tractor may be biased to have a relaxed, expanded configuration with a diameter larger than the outer diameter (OD) of the elongated everting support catheter. Additionally, the tractor tube may be configured (e.g., by heat setting, etc.) so that when the tractor tube is everted inside out and threaded into the elongate everting support catheter at the distal end opening, the outer diameter of the tractor tube within the elongate everting support catheter is approximately y times the inner diameter of the elongate everting support catheter (e.g., y is greater than 0.1, 0.5, 0.6, 0.7, 0.75, 0.8, 0.9, 1, etc. times the inner diameter, ID, of the elongate everting support catheter). This combination of a non-everting diameter of the tractor tube greater than the diameter of the OD of the elongate everting support catheter and an everting diameter of the tractor tube greater than, for example, 0.7 times the ID of the elongate everting support catheter is surprisingly useful in preventing snagging of the device both during device deployment and when the tractor is rolled over the distal end opening of the elongate everting support catheter to capture a thrombus. The tractor may be expandable and coupled to a puller as shown. In some embodiments, the flexible tractor and puller may comprise the same material, but the tractor may be more flexible and / or expandable, or may be connected to an elongated puller (e.g., a push / pull wire or catheter).

[0079] 1C, the thrombus is drawn into the elongated everting support catheter by pulling the tractor proximally into the distal end of the elongated everting support catheter, as shown by arrows 113, 113', which shows how pulling on the inner portion of the flexible tractor causes the tractor to fold back into the distal end of the catheter at the end opening, everting the expandable distal end region and drawing it into the catheter, as shown by the arrows. The ends of the tractor outside the catheter may be "free" from the outer wall of the catheter.

[0080] FIG. 2 illustrates an example of an everting tube device 201 similar to that shown in FIG. 1A. In this example, the everting tube device is located within a large vessel containing a thrombus with a diameter greater than twice the inner diameter of the everting support catheter. While the thrombus can be captured and removed by an everting tube device 201 with a smaller diameter everting support catheter, the efficiency of everting may be low, requiring, for example, flexible tubing approximately 12 times the length of the everting tube to capture the entire thrombus. This illustration illustrates the problem addressed by the devices described herein, specifically, how long, large-diameter thrombus (e.g., greater than 10 mm) can be efficiently captured within a relatively small-diameter everting tube device. In this example, a thrombus with a diameter of 10 mm or greater can be drawn into the 3 mm diameter (e.g., 8 French) everting support catheter of the everting tube device, but the length of flexible tubing required to capture the entire length of the thrombus is very long, resulting in low efficiency. Specifically, a 10 mm diameter, 1 cm long clot would require 12 cm of flexible tubing to evert and retract into a 3 mm catheter, whereas a 5 cm long clot would require 60 cm of flexible tubing. The everting tube device described herein can address and improve this efficiency in several ways.

[0081] In particular, the methods and everting tube devices described herein can dehydrate a thrombus as it is drawn into the everting tube device. Even if the thrombus is hard and partially calcified, it may contain a significant amount of fluid that is compressed and removed by the everting tube devices described herein. For example, the flexible tube is typically porous and may be, for example, a braided material. Furthermore, in some embodiments, the distal end region of the everting support tube, particularly the distal end region (e.g., distal 5 mm, distal 4 mm, distal 3 mm, distal 2 mm, distal 1 mm, distal 0.9 mm, distal 0.8 mm, distal 0.75 mm, distal 0.7 mm, distal 0.6 mm, distal 0.5 mm, distal 0.4 mm, etc.), may be porous to allow fluid to escape laterally from the thrombus and out of the everting support catheter as the thrombus is drawn into the elongated everting support catheter, thereby more efficiently compressing the thrombus rather than stretching or elongating it. In particular, devices and methods are described herein that include a funnel-shaped distal end on an everting support catheter, which is porous (especially in a region near the base of the funnel) and capable of compressing thrombus material as the thrombus is drawn proximally into the everting support catheter by a flexible tube (e.g., a tractor) threaded around it, and of draining / removing fluid from the thrombus laterally out the side of the everting support catheter. The funnel may be expandable (also referred to herein as collapsible) and may be integral with or attached to the distal end of the everting support catheter. The funnel may be collapsed for introduction through a sheath / guide catheter (e.g., an intermediate catheter) and, in its collapsed state, may fit into 6 French, 8 French, 10 French, 12 French, 14 French, 16 French, 28 French, 20 French, and / or 24 French sheaths. The expandable funnel may be self-expanding.Alternatively or additionally, the expandable funnel at the distal end of the everting support catheter can be expanded by actuation of a flexible tube, e.g., by pulling the flexible tube proximally into the everting support catheter and threading the flexible tube around the distal end of the everting support catheter, thereby applying a proximally directed compressive force and thereby pulling and expanding the expandable funnel. The funnel can have a maximum outer diameter greater than 2 times (e.g., greater than 2.5 times, greater than 3 times, greater than 3.5 times, greater than 4 times, greater than 4.5 times, greater than 5 times) the maximum outer diameter of the collapsed configuration, which is approximately the same as or slightly larger than the maximum outer diameter of the body region of the everting support catheter (e.g., 1 times, 1.01 times, 1.1 times, 1.2 times, etc., the outer diameter of the proximal portion of the everting support catheter). In some embodiments, the funnel has an outer diameter of 2 to 26 mm.

[0082] In any of these embodiments, the flexible tubing can be adapted to better capture and compress large diameter thrombi. For example, the flexible tubing in its non-everted configuration when outside the everting support catheter (e.g., within a blood vessel) can have an outer diameter selected to be about the same as or larger than the maximum outer diameter of the funnel in its expanded configuration.

[0083] The expandable funnel can enable the flexible tube (e.g., woven tractor) to capture the thrombus at the edge of its cross section rather than at its center, thereby allowing for more efficient thrombus capture.

[0084] In embodiments of the flexible tubes described herein (e.g., tractor embodiments), it may be beneficial to heat-set the expanded, non-everting outer diameter of the flexible tube (e.g., the portion of the flexible tube outside the everting support catheter before being drawn into the catheter and everted) to a diameter (OD) larger than the maximum outer diameter of the expanded funnel, preferably as large as possible relative to the OD of the thrombus. A larger OD of flexible tube may be more effective at capturing and compressing the thrombus. This may be independent of whether or not there is a funnel at the distal end of the everting support catheter. For example, in the case of flexible tubes (e.g., tractor) formed of a woven material, the OD of the non-everting flexible tube may be selected to be at least 1 / 3 the OD (or vessel ID) of the thrombus. For example, the non-everting, expanded flexible tube may have an OD that is about 50%, 60%, 70%, 80%, 90%, 100%, or 110% or more of the OD (or vessel ID) of the thrombus.

[0085] As mentioned above, the distal end of the everting support catheter, particularly the expandable funnel at the distal end, may be porous. The ability to allow fluid from the compressed thrombus to exit the sidewalls of the funnel inner diameter (e.g., laterally relative to the wall of the everting support catheter, rather than just from the distal and proximal ends) can provide a place for fluid removed from the thrombus and improve the efficiency of the device, allowing for the use of a much shorter flexible tube to remove a comparable length of thrombus. If the thrombus cannot escape laterally (e.g., when using a non-porous funnel), the removed fluid may pool at the base of the funnel, reducing the efficiency of the thrombus removal. For this reason, in some embodiments, the funnel is porous or at least partially porous, for example, near the base of the funnel, where the thrombus compression ratio is highest.

[0086] In any of the embodiments described herein, the everting support catheter can be relatively large, so that it does not need to compress the thrombus as much. In the peripheral vasculature, for example, the everting support catheter can have an outer diameter greater than 1 mm, e.g., greater than 1 mm, 1.2 mm, 1.4 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, or 5 mm.

[0087] Generally, any of the devices described herein can also improve the effectiveness of the device for removing a thrombus by reducing the force required to remove the thrombus. For example, the methods and devices described herein can include a lubricious material on the distal end (e.g., funnel) of the everting support catheter. For example, in any of these devices, the funnel can be lined with a slippery material (e.g., a PTFE liner), which can result in lower entrapment force and / or lower entrapment efficiency. A slippery funnel can allow thrombus material to be entrapped at the mouth of the funnel rather than being pulled into the catheter.

[0088] In some embodiments, the funnel can be configured with a particular shape (e.g., a taper) that helps increase the efficiency of compressing and / or dehydrating the clot and helps reduce the amount of force required. For example, in some embodiments, a longer funnel can have a lower capture force and better clot capture efficiency compared to a shorter funnel with the same maximum OD / minimum ID. Exemplary funnels can have maximum ODs of, for example, 3 mm, 5 mm, 6 mm, 8 mm, 10 mm, 12 mm, 15 mm, 20 mm, 25 mm, etc. Exemplary funnel lengths can be, for example, 5 cm, 10 cm, 15 cm, 20 cm, 25 cm, 30 cm, 40 cm, 50 cm, 100 cm, etc. The body portion of the elongated flexible everting catheter may be, for example, a 3 French (F), 4F, 5F, 6F, 7F, 8F, 9F, 10F, 11F, 12F, 14F, 16F, 18F, 20F, 25F, etc. catheter.

[0089] In embodiments where the flexible tube is made of a woven material, a looser weave may be more efficient. For example, the greater the number of fabric "fingers" (e.g., loops) across the tube (per fabric circumference), the greater the efficiency of thrombus capture. For example, the number of capturing fingers may be at least 10, 20, 20, 40, 50, 60, 100, etc. per tubular fabric circumference.

[0090] Typically, the everting tube devices described herein may be highly flexible, both before and during actuation. For example, the flexible tube (e.g., tractor) may not significantly increase the stiffness / flexibility of the elongated everting support catheter, particularly the distal end region of the catheter, so as not to affect maneuverability. Described herein are flexible tractor tube sections that increase in stiffness by less than a predetermined percentage (e.g., less than 10%, 12%, 15%, 18%, 20%, 25%, 30%, etc.) over the last y cm of the catheter (e.g., the most distal 20 cm, 18 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, etc.). For example, the present specification describes a flexible tractor tube section that passes through the catheter and is doubled over at the distal end of the catheter, but the increase in stiffness of the distal 5 cm of the catheter is less than 15% of the stiffness of the distal 5 cm of the catheter without the flexible tubing that passes through the catheter and is doubled over at the distal end of the catheter.

[0091] The flexible tube (e.g., tractor) may be woven, braided, and / or braided. For woven and braided materials, which may include multiple fibers woven or braided to form an everting tube, their structure can be tailored to prevent snagging and / or reduce the force required to pull the tractor and evert the catheter tip. For example, a mechanical atherectomy device may include a braided or woven flexible tube that can freely fold around the catheter tip when capturing a thrombus, even in tortuous anatomy, by tailoring one or more of the braid structures, minimizing the braid angle, including a hydrophilic coating on the distal side of the catheter's outer diameter (OD) or inner diameter (ID) of the braid (e.g., tractor), including a radiused wall on the catheter, and / or increasing the stiffness of the distal tip region relative to the adjacent proximal region. Alternatively, it may be advantageous to apply a hydrophilic coating to 1, 3, 5, 10, or 15 cm of the distal ID or the entire catheter ID.

[0092] As previously mentioned, the flexible tubing (e.g., tractor) can be braided, woven, knitted, etc., and can be configured to fold as small as possible within the catheter's inner diameter (ID). For example, the tractor can be folded to an ID greater than or less than 90%, 85%, 75%, 70%, 65%, 60%, or 50% of the catheter ID / catheter tip OD. This is because, if this ID were based on the elongated body region of an everted support catheter, pulling the tractor around the catheter tip would create axial tension in the tractor (e.g., braided, knitted, etc.), potentially causing the tractor to inadvertently and undesirably snag on the catheter tip. When the tractor is pulled around the catheter tip, the tractor is pulled axially as it is pulled through the catheter ID, creating axial tension in the tractor structure. Packing the tractor elements at 90%, 85%, 75%, 70%, 65%, 60%, or 50% or more of the catheter ID (or in some embodiments, OD) reduces the likelihood of the tractors catching / synchronizing with the catheter tip when axial tension is applied, allowing less axial force applied by the user to help the braid fold back around the catheter tip. When less axial force is required by the user to pull the tractor structures around the tip, the catheter tip is less likely to buckle or deflect when retracting the tractors. Minimizing the likelihood of the catheter tip buckling can be advantageous. The tractor can be tuned to "pack" at a specific ID by controlling any of the following variables in any combination: selecting a specific number of braid ends, selecting the braid end size / diameter, selecting the braid material (e.g., multifilament or monofilament), heat setting the bias on the braid (e.g., braid diameter), selecting the braid pattern, e.g., 1x2, 1x1, or any other pattern.

[0093] The braid angle is minimized to prevent lock-up of the tractor rolling at the catheter end opening. Typically, a lower braid angle (e.g., 45 degrees or less, 40 degrees or less, 35 degrees or less, 30 degrees or less, 25 degrees or less, 20 degrees or less, etc.) reduces the likelihood of the braid intersections getting caught on the catheter tip.

[0094] In any of the embodiments described herein, the surface of the catheter and / or tractor can be coated to facilitate rolling at the distal end region of the catheter. It may be useful to have a hydrophilic coating on the distal side of the catheter OD or tractor ID so that the tractor can more easily slide around the tip of the catheter at the distal end of the catheter as it is pulled through the interior of the catheter.

[0095] The stiffness of the distal portion of the elongate eversion support catheter is sufficient to prevent collapse when the tractor is pulled, and the distal portion of the catheter can also be made smooth (e.g., by a coating or material property). The most distal portion of the elongate eversion support catheter tip (e.g., the last 5 mm) can be made of a material that is sufficiently stiff and smooth to prevent the distal tip of the catheter from collapsing or buckling inward as the braided structure rolls around the catheter tip. For this reason, the distal tip can have a greater stiffness than more proximal regions at the distal end of the catheter.

[0096] Figures 3A and 3B and 4A and 4B each show examples of everting tube devices including a funnel region at the distal end of an everting support catheter. For example, Figure 3A shows a first embodiment of an everting tube device 300 including an elongated, flexible everting support catheter 307 with an expandable funnel 308 at its distal end, which is shown in the collapsed configuration of Figure 3A within an intermediate (e.g., delivery) catheter 309 and in the expanded configuration of Figure 3B after being released from the intermediate catheter. The funnel can be formed of a woven material and can be porous, particularly in the base region 313 where the funnel extends from the elongated body of the everting support catheter. A flexible tube 305 extends beyond the distal end of the everting support catheter (including the funnel) and everts at the distal opening of the funnel. The flexible tube may be, for example, a braided material and may be biased to expand to an outer diameter (OD) in the expanded configuration that is larger than the OD of the funnel 308. The flexible tube is attached to a distal end region of the puller 303. In the example shown in Figures 3A and 3B, the puller extends distally 315 beyond the distal end of the funnel as shown. A flexible tube (e.g., a tractor) is attached to the distal end region of the puller, but in this example, the end of the flexible tube is attached proximal to the distal end of the device.

[0097] In the example of the everting tube device 400 shown in Figures 4A and 4B, a flexible tube 405 is attached to the distal end region of the puller 403 near the distal end of the puller or at the distal end of the puller. Figure 3A shows the everting tube device 400 within an intermediate catheter (e.g., a delivery catheter) 409, with a funnel 408 attached in a collapsed configuration to the distal end of an everting support catheter 407 within the intermediate catheter. The funnel can include one or more (e.g., multiple circumferentially arranged) openings or holes in the region of the base 413, allowing fluid from the thrombus to exit the everting support catheter as it is drawn into the everting support catheter by the surrounding flexible tube 405 (e.g., tractor region). Figure 4B shows the device at least partially deployed out of the intermediate catheter 409, with the expandable funnel 408 expanded.

[0098] Figure 4C is a photograph of a prototype device 400' in which an everting support catheter 407' includes an expandable funnel 408' (shown in an expanded state) that, when used as a clot removal device, allows the flexible tube 405' to evert around and capture thrombus material. In Figure 4C, the flexible tube is shown as a braided tube that forms multiple (e.g., greater than 15) loops or fingers at the distal-facing end of the device that aid in capturing thrombus material. This is shown in more detail in Figures 5A and 5B.

[0099] 5A and 5B show porous funnel 508 forming the distal end of everting support catheter 507, and show that braided flexible tubing 505 everts into the funnel when the flexible tubing is pulled proximally into the funnel.

[0100] In some embodiments, the expandable funnel can be formed of a woven and / or braided material, as shown in FIGS. 6A-6D. For example, in FIG. 6A, the funnel is configured to handle the relatively large compressive loads required to compress and / or dehydrate a large-diameter thrombus as it is drawn into the device. While funnel 608 is shown in a collapsed configuration in FIG. 6A, the funnel can be collapsed to a smaller OD and introduced through a small ID sheath, e.g., by elongating the funnel shape, as shown. The funnel may self-expand, e.g., to a fully or partially expanded configuration upon release from a delivery catheter within a vessel, as shown in FIG. 6B. In some embodiments, the funnel can expand further (more fully) when pressed into the thrombus or against a body 609, as shown in FIG. 6C, so that a compressive force 611 can be applied proximally to the funnel to compact it into a stronger configuration, as shown in more detail in FIG. 12, described below. 6D is a distal perspective view of the funnel end of the everting support catheter, showing the braided tractor (braided flexible tubing) 603 everted into the funnel. In this example, the funnel flares outward from 5 mm ID to 8 mm ID in the expanded configuration.

[0101] 7A and 7B show an example of an everting tube device having a flexible tube (e.g., a braided tractor tube 703) and an everting support tube 705 including an expandable funnel 708 that captures a thrombus 711. FIG. 7A shows the thrombus and device prior to capture. FIG. 7B shows the thrombus within the flexible tube captured in the everting support catheter after the flexible tube has been removed from within the everting support catheter (the braided flexible tube is shown attached to a puller 709). Similarly, FIGS. 8A and 8B show another example of an everting tube device 800 in which an everting support catheter 807 without a funnel at its tip is heat-set so that the woven flexible tube (tractor tube) has an outer diameter approximately equal to the OD of the thrombus 811, resulting in relatively high thrombus efficiency, as shown in FIG. 8B, which shows the captured thrombus 811′ after removal from the device.

[0102] As shown in Figures 9A-9C, thrombus removal efficiency generally increases with the outer diameter of the flexible tubing. Figure 9A shows an example of an everting tube device (thrombus removal device) 900, including an everting support catheter 907 and a woven flexible tube 905. Figure 9B is a graph showing the length (in centimeters) of the device's braided flexible tubing (tractor tube) required to completely capture a thrombus measuring 15 mm in outer diameter and 5 cm in length. As shown, the larger the outer diameter of the flexible tubing in its un-everted, expanded configuration, e.g., outside the everting support catheter, the smaller the required length of braided flexible tubing. Figure 9C shows various everting tube devices and their exemplary dimensions.

[0103] Any suitable expandable funnel-shaped distal end can be used. For example, Figures 10A-10C show various embodiments of funnel-shaped distal ends. Figure 3A shows a funnel 1013, which can be solid or include openings (e.g., porous) that allow fluid to pass through, and the entire surface can be porous. Figure 10B shows an example in which only a portion of the expandable funnel is porous. In Figure 10B, the base region 1023 is porous and includes multiple openings circumferentially arranged around the periphery of the base region of the funnel 1013.

[0104] The embodiment of the expandable funnel 1013 shown in Figure 10C is shown to be porous along its entire length and formed of a woven material (e.g., metal or polymer fabric) doubled over on itself to form a funnel shape. Figure 10D is a cross-sectional view of the embodiment of Figure 10C, showing the attachment 1021 of the tubular fabric forming the funnel to the outside of the body region of the elongated flexible everting support catheter 1007, and the second end 1025 of the funnel portion within the mouth of the funnel. Either of these embodiments can include a lubricious sleeve (e.g., a Teflon sleeve).

[0105] 11A-11D show an example of the distal end of an everting support catheter including a funnel. In this example, the funnel is integrally formed with the body of the everting support catheter. As shown in the schematic diagram of FIG. 11A, the funnel shape includes a framework formed by multiple fingers or struts 1111 formed by cutting (e.g., laser cutting) the distal end of the body of the everting support catheter 1107. In FIG. 11A, a braided or woven funnel body 1118 is attached to the struts, with one end of the woven body attached to the body of the everting support catheter (1105) and the other end 1109 fixed in place on the struts. FIG. 11B shows an example of an elongated support catheter body cut into multiple struts or fingers on which the funnel body is supported, as shown in FIG. 11C. The distal end of the funnel 1131 is open, allowing it to extend beyond the struts, and can be filled to form a fixed, open configuration with high compressive strength even in the absence of underlying struts or fingers. FIG. 11D shows an example of the open distal end of the funnel of the device.

[0106] FIG. 12 is a close-up of the distal end of the funnel shown in FIG. 11C, showing that application of an axial compressive force "clogging" the distal end of the device, resulting in a larger braid angle compared to the more proximal end that is not clogged. JPEG0007781191000001.jpg7170 at the distal end. This compressive force may help open (and hold open) the expandable funnel.

[0107] 13A-13D show another embodiment of a funnel portion of an everting support catheter, including a lubricious sleeve (e.g., a Teflon sleeve). FIG. 13A shows a schematic diagram in which the funnel is formed from multiple arms 1303, with a braided funnel body 1305 bonded onto arms formed from the body of an everting support catheter 1307 (similar to the embodiment shown in FIGS. 11A-11D). The braided body may be bonded to a catheter body 1316. Additionally, a Teflon sleeve 1309 may be attached at one or more locations along the OD of the braided body region, as shown. In FIG. 13A, the base region is not covered by the Teflon sleeve, allowing fluid to exit the funnel laterally near the base of the funnel.

[0108] Figure 13B is a side view of the prototype eversion support catheter of Figure 13A, shown in a side perspective view in a collapsed (unexpanded) configuration. Figure 13C shows the funnel in an expanded configuration. A Teflon sleeve 1309 is partially attached to the outside of the expanded funnel along its length. Figure 13D shows an end view of the distal end of the funnel of the eversion support catheter of Figures 13B and 13C.

[0109] 14A-14C show different examples of lubricious sleeves that can be included in any of the illustrated devices. In FIG. 14A, a Teflon sleeve (PTFE tubing) is attached inside the mouth of the funnel, with the mat attached at the distal end but allowed to float at the proximal end. Alternatively, in FIG. 14B, a lubricious sleeve (PTFE sleeve) is attached underneath a woven body forming a funnel shape and is either bonded or allowed to float at the proximal end. In FIG. 14C, the lubricious sleeve is attached to the outside and inverted at the distal end of the funnel shape, allowing it to float proximally (or be attached proximally).

[0110] Figures 15A and 15B show another embodiment of an inverted support catheter that includes a funnel. In Figure 15A, the funnel is formed from a set of laser-cut fingers to form a funnel shape, and funnel body material is attached inside and / or over the funnel shapes, as described above. In Figure 15B, the end of the catheter body is laser-cut into multiple curved arms that form the funnel shape.

[0111] As previously mentioned, a variety of different configurations and sizes are available, and the user can choose from them based on the size of the vessel in which the device will be used. For example, Figures 16A-16D show four variations of everting tube devices that may be used. In Figure 16A, a 5 French device is shown that does not include a funnel at the distal end of the everting support catheter. Figure 16B shows an example (sized for a 6F system) that includes an everting support catheter with an expandable funnel. Figures 16C and 16D show 8F and 10F devices, respectively.

[0112] 17A-17C show embodiments in which the flexible tube is configured to have an expanded (e.g., uncompressed) configuration that is narrow (FIG. 17A), e.g., smaller than the maximum OD of the expanded funnel, or wide (FIGS. 17B and 17C), e.g., larger than the maximum OD of the expanded funnel. In FIG. 17C, a delivery catheter 1705 can be used to drive the flexible tube distally (e.g., to prevent tension) as the flexible tube is threaded through the funnel at the distal end of the everting support catheter by pulling a first end of the flexible tube proximally within the everting support catheter.

[0113] Also described herein are everting tube devices configured for atherectomy. In some embodiments, the everting tube device includes a flexible tube and an everting support catheter (e.g., one having an expandable funnel at its distal end) and can further include one or more ring cutters for cutting through and / or around an atheroma within a blood vessel. For example, FIG. 18A shows an example of an everting tube device including a pair of ring cutters (e.g., Moll Ring cutters) used to transversely cut an atheroma. The ring cutters can pass outside the everting support catheter. The everting flexible tube in some embodiments can be formed of a sharp or cutting material, such as a sheet of laser-cut material (e.g., metal, polymer, etc.) cut at an angle to the vertical to provide a sharp edge capable of engaging and cutting calcified material and / or tissue. The cutting rings may further enable cutting into and through dense plaque material.

[0114] Any of the everting support catheters described herein that include an expandable / collapsible funnel at its distal end can be configured to collapse to a smaller diameter to facilitate insertion into a catheter and / or sheath, including when a flexible tube (e.g., a tractor) is pre-loaded around the funnel. In use, a tool such as an introducer sheath can be used to hold the distal end (e.g., funnel) of the everting support catheter in a collapsed configuration, regardless of whether a flexible tube is attached, allowing for easy insertion into the lumen of a delivery catheter already in place within the body or a delivery catheter that will be inserted into the body along with the everting support catheter and flexible tube assembly. Collapsing the distal end funnel to a smaller diameter can aid in threading the "loaded" everting support catheter into the delivery catheter and, ultimately, the body. When a tool such as an introducer sheath is used, it can be removed during or after loading; the introducer sheath may be a tapered tube made of a polymer (e.g., plastic) with a slit, perforation, or tear region extending along its length. The funnel can be collapsed and inserted into the wider end of the introducer sheath, and the everting support catheter can be pushed to slide distally into the narrower end of the introducer sheath. The narrower end can then be loaded into the delivery catheter, the everting support catheter can be pushed distally from the introducer sheath into the delivery catheter, and the introducer sheath can then be collapsed (e.g., along a pre-formed tear line) along its length for removal from around the everting support catheter. An example introducer sheath is shown in FIG. 25 and is described in more detail below.

[0115] The funnel portion of the everting support catheter may be configured to collapse at least its distal end region to a diameter smaller than the diameter of the remainder of the everting support catheter, e.g., the region proximal to the funnel. For example, the funnel may be configured to collapse to fit within a 3F, 4F, 5F, 6F, 7F, 8F, 9F, 10F, 12F, 14F, 16F, 18F, 20F, 24F, 30F, etc. sheath or guide catheter (also referred to herein as a delivery catheter).

[0116] The funnel portion of the everting support catheter can be adapted for this purpose in a variety of ways, including, but not limited to, features of the components forming the funnel portion. For example, in some embodiments, the outer and inner surfaces of the funnel portion can be formed of a mesh material, such as a braid. The particular mesh or braid structure can contribute to the amount by which the funnel can be folded, including the number of filaments (e.g., number of ends) forming the braid, the size of the filaments (e.g., end size), and the braid angle. In some embodiments, where the funnel includes multiple longitudinal tines between the inner and outer surfaces formed by the mesh or other material, the ability to fold the funnel portion is determined in part by the ability of the tines to move within the inner and outer surfaces (e.g., of the mesh or woven material forming the funnel walls). For example, the braided tube forming the funnel walls can slide relative to the tines to allow the funnel to be folded to a smaller diameter for introduction.

[0117] FIG. 19 shows a portion of an example everting support catheter having a funnel at its distal end. The funnel can be formed in part by a plurality of tines 1905 extending from the distal end of the everting support catheter. For example, the distal end region of the everting support catheter can be formed from a metal hypotube that is transversely cut, e.g., by laser cutting, to form the tines. Six tines are shown in FIG. 19. The tines can be flared outward from one another, e.g., on a mandrel (as shown in FIG. 20A). In some embodiments, as shown in FIG. 19, the tines can be formed by folding a cut arm back on itself to form a blunt or rounded distal end 1909. In this example, the folded portion of the tine 1907 is folded inward and crimped together as shown. In some embodiments, a filament can be included to radially connect each tine of the plurality of tines. This is shown in FIGS. 20A and 20B. In this example, the filament 2007 is a suture threaded through the distal end (the portion that is folded back on itself) of the tine 2005. Typically, the filament is attached at or near the distal end of the tine (e.g., within 1 mm, 2 mm, 3 mm, 4 mm, etc. from the distal end). Each tine 2005 shown is connected to radially adjacent tines by filament 2007. Connecting the tines (including their distal ends) to one another along their length can help distribute forces that could collapse and / or bend the tines and impair the function of the eversion support catheter.

[0118] 21A and 21B show an example of a mesh material used to form the outer and inner surfaces (e.g., walls) of a funnel. FIG. 21A shows a tube 2100 of mesh (e.g., woven) material, which is folded back on itself as shown to form inner surface 2103 and outer surface 2104. To form the funnel, tines are inserted between the inner and outer surfaces, with their outer ends attached to the outside of the proximal region of the everting support catheter. The material (e.g., braid) forming the wall is shape-set (e.g., heat-set) into this double layer. Specifically, in a packed configuration, the material can be shape-set so that the inner layer has an outer diameter (OD) that is smaller than the inner diameter (ID) of the outer layer, thereby creating space for the tines to slide through.

[0119] Figure 21B is an enlarged view of a portion of the braided wall material of Figure 21A. In Figure 21B, the braided material is shown as a braid of flat wires, with round and / or flat cross-section wires being used to form the braided material. As noted above, the braid angle can be selected to allow for compression of the funnel and to set a packed configuration when the funnel is most expanded.

[0120] FIGS. 22A-22C show a funnel 2200 formed by applying a braided wall material, such as that shown in FIG. 21A, to the tines at the distal end of an eversion support catheter, such as that shown in the example of FIG. 19. In FIG. 22A, the inner and outer walls of the woven material forming the funnel are sewn together by sutures 2221, which are radially disposed around the funnel and restrain it from further expansion, as described above. The tines can slide axially relative to the inner and outer walls. In any of the funnels described herein, the mesh material forming the inner and outer walls may extend distally beyond the distal ends of the tines. In the relaxed configuration shown in FIG. 22A, the length of the braid distal to the distal ends of the tines 2214 is shown as distance X 1 mm. FIG. 22B shows a funnel 2213 filled with braid, as it would appear if a tractor (e.g., flexible tubing) were mounted over the funnel and pulled proximally into the eversion support catheter. In this configuration, the axial length of the braided wall extending beyond the tips of the tines is X2 mm. Figure 22C shows the collapsed state (and loaded into the introducer sheath 2217), in which the axial length of the braided wall extending beyond the tips of the tines is X3 mm.

[0121] In some embodiments, it may be beneficial to limit the axial length of the braided wall that extends beyond the tips of the tines in the fully expanded (e.g., packed) configuration. This can prevent instability, particularly lateral instability. For example, it may be beneficial to limit the axial length of the braided wall that extends beyond the tips of the tines in the fully deployed (e.g., packed) configuration to 10 mm or less (e.g., 8 mm or less, 7 mm or less, 6 mm or less, 5 mm or less, 4 mm or less, 3 mm or less, 2 mm or less, e.g., 1 mm to 10 mm, 1 mm to 8 mm, 1 mm to 7 mm, 1 mm to 6 mm, 1 mm to 5 mm, 1 mm to 4 mm, etc.). In particular, it may be beneficial to limit it to 5 mm or less.

[0122] 23 shows another example of an everting catheter including a funnel as described above. In this example, the funnel 2300 includes sutures 2413 (e.g., restraining filaments) integrated between the inner and outer layers (e.g., walls) of the funnel to prevent relative sliding of the inner and outer braided layers while allowing sliding of tines 2318 between the inner and outer braided material walls, resulting in a clogged braid at the tip. The sutures limit the diameters 2305, 2307 of the funnel in the expanded configuration, as shown.

[0123] In some embodiments, the outer diameter of the funnel at various locations along its length can be limited or set by the use of constraining filaments, such as sutures, wires, etc. Constraining filaments are sometimes referred to herein as circumferential supports that extend radially around the surface of the funnel and constrain the maximum outer diameter of the expandable funnel. The constraining filaments may be held in place by suturing them to a mesh (e.g., woven) material that forms the funnel wall. That is, the filaments can constrain the OD of the funnel to a desired diameter / profile.

[0124] As described above, each of these funnels includes a porous structure that allows fluid to seep through the sides of the funnel, thereby partially dehydrating the clot or tissue when drawn through the base of the funnel. The funnels described herein can have a smooth transition from the funnel ID to the catheter ID. This can be achieved by laser cutting tines at the distal portion of the catheter, as shown. The porous structure and / or smooth transition can also be provided in these examples by a porous metal mesh (e.g., braided) structure forming the wall.

[0125] The everting support catheters described and illustrated herein can be adapted to resist collapse even when subjected to force from a flexible tube, with or without thrombus material. In any of these embodiments, the funnel should be able to handle axial loads (e.g., loads applied along the longitudinal axis of the catheter shaft) of, for example, more than 1, 2, 3, 4, 5, 10, 15, and / or 20 kg without collapsing, for example, when resistance is encountered due to thrombus entrapment, while still allowing a flexible tube (e.g., a tractor) to pass around the tip of the funnel and into the everting support catheter. Axial stiffness can be achieved, at least in part, by configuring the braided wall of the funnel to have a packed configuration at the tip, as described above. Axial stiffness can also be improved by limiting the length of the braided wall that extends beyond the distal tips of the tines in the packed configuration (e.g., by limiting it to 5 mm or less). In some configurations, axial stiffness can also be improved by including circumferential supports (e.g., filaments) between the tines, as described above, which can distribute the loads exerted by the tractor on the funnel tip, keeping the funnel tip round and preventing isolated finger collapse.

[0126] Generally, these same factors can also improve radial stiffness. Preferably, the ends of the funnel are also sufficiently stiff to prevent radial collapse of the funnel when a tractor is routed around the tip. Radial stiffness of the funnel can be achieved, at least in part, by configuring the braided walls of the funnel to have a packed configuration at the tip, as described above. Radial stiffness can also be improved by limiting the length of the braided walls that extend beyond the distal tips of the packed tines (e.g., to 5 mm or less). In some configurations, radial stiffness can also be improved by including circumferential support (e.g., filaments) between the tines, as described above, which can distribute the load exerted by the tractor on the funnel tip, keeping the funnel tip round and preventing any isolated finger collapse.

[0127] In any of the funnels described herein, the funnel may be configured to fully expand only when an axial load is applied, for example, by pulling a flexible tube (e.g., a tractor) proximally around the everting support catheter, thereby allowing the funnel to be advanced into smaller vessels before it is actuated.

[0128] For example, FIG. 24A shows an example of an assembly including an everting support catheter with a funnel as described above, where a flexible tube (tractor) is loaded onto and into the everting support catheter so that the flexible tube extends over the funnel along the outside of the everting support catheter before everting it into the funnel. In FIG. 24A, the funnel 2405 is not fully expanded, and the braided flexible tube 2403 is not retracted into the everting support catheter. In FIG. 24B, the flexible tube 2403 is retracted into the everting support catheter so that it wraps around the catheter, and the flexible tube / tractor applies an axial load, fully expanding the funnel 2405 into its packed configuration. The portion 2407 of the funnel wall that extends beyond the tines in the relaxed configuration shown in FIG. 24A is greater than the length 2409 of the funnel wall that extends beyond the tines in the packed configuration shown in FIG. 24B.

[0129] As mentioned above, any of the devices described herein may be packaged or otherwise included together to form, for example, a kit for removing a thrombus. For example, FIG. 25 shows an example of a system for performing a thrombectomy procedure packaged together. In FIG. 25, the system 2500 includes pre-loaded components, such as an everting support catheter 2512 pre-loaded with a tractor (flexible tubing), and the flexible tubing and everting support catheter assembly is enclosed in a loading sheath 2503 (a spare loading sheath 2522 is also shown) for loading into a delivery catheter (not shown). The flexible tubing and everting support catheter assembly is also proximally covered by a tear-away sleeve 2511 that extends over the flexible tubing and everting support catheter and is configured to be removed from over the flexible tubing by tearing along the length of the tear-away sleeve when the everting support catheter and flexible tubing are loaded into the delivery catheter. A pair of locks 2514 are also shown as part of the kit in Figure 25. Also included in Figure 25 are a pair of additional tractors 2520 (flexible tubing) connected to the puller, which can be loaded onto the everting support catheter after the pre-loaded tractors are completely removed.

[0130] For example, the additional flexible tubing can be loaded onto the everting support catheter after the original everting support catheter is pulled through the lumen of the everting support catheter, such as when removing a thrombus. In some embodiments, the additional flexible tubing is attached to a puller, and a portion (e.g., a first portion) of the puller and additional flexible tubing is pulled through the distal end (funnel end) of the everting support catheter, while a second portion is pulled outside of the everting support catheter.

[0131] Any of the everting support catheters 2601 described herein can include a stopper 2607, as shown in FIG. 26. The stopper can prevent the proximal end 2603 of the tractor (flexible tubing) from being pushed proximally beyond the stopper, for example, when loading the assembly of flexible tubing and everting support catheter into a delivery catheter and / or when loading the flexible tubing into the everting support catheter, as described above. For example, the stopper can engage with a cuff (e.g., an elastic cuff) 2609 on the end of the tractor. A tear-away sleeve may also help reduce or prevent this.

[0132] 27A and 27B show one example of a lock 2701 that can be used to secure an everting support catheter 2711 to a delivery catheter 2713 so that the two can move together. As shown in FIG. 27A, the lock can include a circular clamp 2703 for connecting to the outside of the everting support catheter and an L- or J-shaped lock 2705 for coupling to the end of the delivery catheter. By loosening or tightening the circular clamp, the everting support catheter can be slid independently or coupled to the delivery catheter.

[0133] Any of the methods described herein (including those related to user interfaces) may be implemented as software, hardware, or firmware and may be described as a non-transitory computer-readable storage medium storing a set of instructions executable by a processor (e.g., a processor of a computer, tablet, smartphone, etc.) which, when executed by the processor, causes the processor to control the performance of any steps including, but not limited to, displaying, interacting with a user, analyzing, changing parameters (including timing, frequency, intensity, etc.), making decisions, alerting, etc.

[0134] When a structure or element is referred to as being "on" another structure or element, it may be directly on the other structure or element, or intervening structures and / or elements may be present. In contrast, when a structure or element is referred to as being "directly on" another structure or element, there are no intervening structures or elements present. When a structure or element is referred to as being "connected," "attached," or "coupled" to another structure or element, it may be directly connected, attached, or coupled to the other structure or element, or intervening structures or elements may be present. In contrast, when a structure or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another structure or element, there are no intervening structures or elements present. Although described or illustrated with respect to one embodiment, the described or illustrated structures and elements may also be applicable to other embodiments. Those skilled in the art will also understand that a reference to a structure or element being disposed "adjacent" to another structure may have portions overlapping or underlying the adjacent structure.

[0135] The terms used herein are for the purpose of describing particular embodiments only and are not intended to limit the present invention. For example, as used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly dictates otherwise. As used herein, the terms "comprises" and / or "comprising" specify the presence of stated structures, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more of other structures, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ."

[0136] Spatially relative terms such as "under," "below," "lower," "over," "upper," and the like are used herein to facilitate the description of one element or feature's relationship to other elements or features, as illustrated. It will be understood that these spatially relative terms are intended to encompass various orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, an element described as "under" or "beneath" another element or feature would be positioned "above" that other element or feature. Thus, the exemplary term "under" can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein will be interpreted accordingly. Similarly, unless otherwise noted, terms such as "upward," "downward," "vertical," "horizontal," and the like are used for descriptive purposes only.

[0137] The terms "first" and "second" are used herein to describe various components / elements (including steps), but these components / elements should not be limited by these terms unless the context dictates otherwise. These terms are used to distinguish one component / element from another. Thus, a first component / element described below can also be referred to as a second component / element, and similarly, a second component / element described below can be named the first component / element without departing from the teachings of the present invention.

[0138] Throughout this specification and claims, unless the context requires otherwise, the word "comprise" and variations such as "comprises," "comprising," etc., mean that various components may be used together in methods and articles (elements and apparatuses, including devices and methods). For example, the term "comprising" is understood to mean the inclusion of all listed elements or steps, but not the exclusion of other elements or steps.

[0139] In general, any apparatus and methods described herein should be understood to be inclusive, although all or a subset of the components and / or steps may alternatively be exclusive, or alternatively may be expressed as "consisting of" or "consisting essentially of" various components, steps, subcomponents, or substeps.

[0140] As used in this specification and claims, including those used in the examples, unless otherwise specified, all numbers are to be construed as preceded by "about" or "approximately." The words "about" or "approximately" may be used when describing a magnitude and / or location to indicate that the stated value and / or location is within a reasonably expected range of values ​​and / or locations. For example, a numerical value may have a value of + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Various values ​​described herein should also be understood to include about or approximately the value unless the context indicates otherwise. For example, if a value of "10" is disclosed, "about 10" is also disclosed. Any numerical ranges recited herein are intended to include all subranges subsumed therein. Where a value is disclosed, "less than or equal to," "greater than or equal to," and ranges of possible values ​​are also disclosed, as would be appropriately understood by one of ordinary skill in the art. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., X is a number) are also disclosed. It is also understood that throughout the application, data is provided in several different formats, and this data represents endpoints and starting points, and ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, values ​​between 10 and 15 are considered to be disclosed, as are values ​​greater than, greater than, less than, and less than 10. It is also understood that each unit between two specified units is disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0141] While various exemplary embodiments have been described, any number of modifications to the various embodiments are possible without departing from the scope of the invention, as defined by the claims. For example, in alternative embodiments, the order in which the various method steps described are performed may often be changed, and in other alternative embodiments, one or more method steps may be skipped entirely. Any configuration of the various apparatus and system embodiments may be included in some embodiments and not in others. Therefore, the above description has been provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention, as defined in the claims.

[0142] The examples and drawings contained herein are illustrative of specific embodiments in which the present invention may be practiced, not limiting. As noted above, other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. Such embodiments of the inventive subject matter, if more than one is actually disclosed, may be individually or collectively referred to solely by the term "invention," without any intention of spontaneously limiting the scope of this application to any single invention or inventive concept. Thus, while specific embodiments have been illustrated and described herein, any configuration calculated to achieve the same purpose may be substituted for the specific embodiments shown. The present disclosure is intended to cover any and all adaptations or modifications of the various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those skilled in the art upon reviewing the foregoing description. The technical ideas included in the present disclosure are described below. (Appendix 1) 1. A thrombus removal system comprising: an eversion support catheter having an elongated flexible catheter body, a catheter lumen, and an expandable funnel disposed at a distal end of the catheter body, the distal end of the funnel defining a distal opening communicating with the interior of the funnel and the catheter lumen, respectively; a flexible tube that is inverted at a distal end of the funnel to have a first region disposed at least partially within the funnel and a second region extending at least partially outside the funnel; the flexible tube is configured to be retracted proximally into the catheter lumen by pulling the first region proximally, and the second region is configured to wrap around the distal end of the funnel as the flexible tube is retracted into the catheter lumen. (Appendix 2) 10. The system of claim 1, a portion of the second region of the flexible tubing extending at least partially onto an outer surface of the catheter body proximal to the funnel, and an inner diameter of the portion of the second region extending onto the outer surface of the catheter body is smaller than a maximum outer diameter of the funnel when the funnel is in an expanded configuration. (Appendix 3) In the system according to claim 1 or 2, A system, wherein a base region of the funnel adjacent a distal end of the catheter body includes an opening configured to allow a fluid to pass therethrough. (Appendix 4) In the system according to claim 1 or 2, 10. The system of claim 9, wherein the funnel includes a circumferential porous region at a base of the funnel adjacent the distal end of the catheter body, the porous region configured to allow fluid to pass therethrough. (Appendix 5) 5. The system according to claim 1, wherein: The system, wherein the funnel has a collapsed configuration with a maximum outer diameter less than 0.3 times the outer diameter of the catheter body proximal to the funnel. (Appendix 6) 6. The system of claim 1, wherein: The system, wherein the funnel has an expanded configuration with a minimum outer diameter greater than two times the outer diameter of the catheter body proximal to the funnel. (Appendix 7) 7. The system of claim 6, The system, wherein the funnel has an outer diameter of 2 to 26 mm in the expanded configuration. (Appendix 8) 8. The system of claim 1, wherein: The system, wherein the flexible tubing comprises a braided tubing. (Appendix 9) 9. The system of claim 8, The system, wherein the knitted tube has more than 10 loops per cross-section of the knitted tube along the length of the knitted tube. (Appendix 10) 10. The system of claim 1, wherein: The system is configured such that the funnel assumes a blocked configuration when a first region of the flexible tube is pulled proximally, exerting an axial compressive force on the distal end of the funnel. (Appendix 11) 11. The system of claim 10, In the clogged configuration, the funnel has a greater column strength than when not in the clogged configuration. (Appendix 12) 11. The system of claim 10, In the packed configuration, the funnel is configured to withstand a compressive force of greater than 1200 g without collapsing. (Appendix 13) 13. The system of claim 1, wherein: The system, wherein the funnel includes a plurality of longitudinal tines continuous with the catheter body proximal to the funnel. (Appendix 14) 14. The system of claim 13, the funnel further includes a mesh that inverts upon itself at a distal end of the funnel, a first portion of the mesh forming an inner funnel surface and a second portion of the mesh forming an outer funnel surface, the plurality of longitudinal tines being disposed between the inner and outer funnel surfaces. (Appendix 15) 15. The system of claim 1, wherein: The system further comprising a lubricating sleeve disposed over at least a portion of the funnel. (Appendix 16) 16. The system of claim 1, The system further comprising an intermediate catheter, the everting support catheter being slidably disposed at least partially within a lumen of the intermediate catheter. (Appendix 17) 17. The system of claim 1, The system further includes a puller disposed within the catheter lumen, the first region of the flexible tube being coupled to a distal end region of the puller. (Appendix 18) 1. A thrombus removal system comprising: an eversion support catheter having an elongated flexible catheter body, a catheter lumen, and an expandable funnel disposed at a distal end of the catheter body, the distal end of the funnel defining a distal opening communicating with an interior of the funnel and the catheter lumen, respectively, and at least a proximal portion of the funnel adjacent the catheter body including an opening configured to allow a fluid to pass therethrough; a puller disposed within the catheter lumen; a flexible tube formed of a braided or woven material, the flexible tube everting at a distal end of the funnel and having a first region coupled to the puller and a second region extending at least partially over an outer surface of the funnel; The system is configured such that the flexible tubing is drawn proximally into the catheter lumen by pulling the puller proximally, thereby causing a second region of the flexible tubing to pass through the interior of the funnel and into the catheter lumen. (Appendix 19) 1. A thrombus removal system comprising: an eversion support catheter having an elongated flexible catheter body, a catheter lumen, and an expandable funnel disposed at a distal end of the catheter body, the distal end of the funnel defining a distal opening communicating with an interior of the funnel and the catheter lumen, respectively, and at least a proximal end of the funnel adjacent the catheter body including an opening configured to allow a fluid to pass therethrough; a braided flexible tube that is inverted at a distal end of the funnel and has a first region that is at least partially disposed within the funnel and a second region that extends at least partially over an exterior surface of the funnel; the flexible tube is configured to be drawn proximally into the catheter lumen by pulling a first region of the flexible tube proximally, and a second region of the flexible tube is configured to wrap around a distal end of the funnel as the flexible tube is drawn into the funnel and into the catheter lumen, respectively; and the funnel is configured such that pulling the first region of the flexible tube proximally applies an axial load to the funnel, causing the funnel to expand into an expanded, packed configuration. (Appendix 20) 1. A method for removing a blood clot from a blood vessel, comprising: advancing the everting tube device through the blood vessel until a distal end of the everting tube device is located adjacent to the thrombus, the everting tube device comprising an everting support catheter having an elongated flexible catheter body, an internal catheter lumen, and an expandable funnel disposed at a distal end of the catheter body, the distal end of the funnel defining openings communicating with the interior of the funnel and the catheter lumen, respectively; the everting tube device further comprising a flexible tube that everts at the distal end of the expandable funnel and has a first region at least partially disposed within the interior of the funnel and a second region extending at least partially over an outer surface of the funnel; expanding the funnel from a collapsed delivery configuration to an expanded configuration within a blood vessel adjacent to a thrombus; and pulling the first region of the flexible tubing proximally to contort the second region of the flexible tubing at the distal end of the funnel, whereby the flexible tubing captures the thrombus and draws it proximally into the interior of the funnel and into the catheter lumen. (Appendix 21) 21. The method according to claim 20, The method, wherein the step of capturing the thrombus and drawing the thrombus proximally into the interior of the funnel and into the catheter lumen includes compressing the thrombus and expelling fluid from the thrombus laterally through a fluid discharge opening in a proximal portion of the funnel. (Appendix 22) 21. The method according to claim 20, The method further comprising selecting a size of the everting tube device based on a size of a blood vessel. (Appendix 23) 21. The method according to claim 20, a first region of the flexible tubing is pulled proximally to constrict a second region of the flexible tubing over a distal end of the funnel, thereby placing the funnel in a plugged configuration. (Appendix 24) 21. The method according to claim 20, The method, wherein the expandable funnel has an outer diameter in the expanded configuration that is at least 1 / 3 greater than the width of the thrombus. (Appendix 25) 21. The method according to claim 20, The method, wherein the expandable funnel has an outer diameter in the expanded configuration that is at least 50% greater than the width of the thrombus. (Appendix 26) 21. The method according to claim 20, The method of claim 1, wherein pulling the first region of the flexible tubing proximally and turning the second region of the flexible tubing at the distal end of the funnel comprises applying a compressive force of 500 g to 3000 g to the funnel. (Appendix 27) 21. The method according to claim 20, The method, wherein expanding the funnel comprises extending the expandable funnel distally out of an intermediate catheter. (Appendix 28) 21. The method according to claim 20, The method further comprising the steps of removing the flexible tubing from the catheter lumen and loading a new flexible tubing into the everting support catheter. (Appendix 29) 21. The method according to claim 20, The method, wherein expanding the funnel comprises allowing the funnel to self-expand. (Appendix 30) 21. The method according to claim 20, The method, wherein expanding the funnel comprises pulling a first region of the flexible tube proximally to expand the funnel. (Appendix 31) 1. A thrombus removal device, comprising: an everting support catheter having an expandable funnel at a distal end of a flexible elongate catheter body, the funnel comprising: a first flexible tube made of a braided or woven material that is everted upon itself to form an inner funnel surface and an outer funnel surface, the inner funnel surface defining an interior of the funnel that communicates with a lumen of the catheter that extends through the catheter body; a plurality of support tines extending distally from the distal end of the catheter body between the inner funnel surface and the outer funnel surface, the inner funnel surface and the outer funnel surface each configured to slide axially relative to the support tines; a second flexible tube made of a braided or woven material extending distally along at least a portion of the outer surface of the catheter body and along the outer funnel surface, and turning back into the interior of the funnel and into the catheter lumen at the distal end of the funnel; The thrombus removal device, wherein the funnel is configured to expand to a stowed configuration when the second flexible tube is pulled proximally into the catheter lumen. (Appendix 32) 32. The apparatus of claim 31, The device, wherein the first flexible tube comprises a woven material. (Appendix 33) 33. The apparatus of claim 31 or 32, The apparatus, wherein the first flexible tube has a braid angle greater than 90 degrees when the funnel is in a plugged configuration. (Appendix 34) 34. The apparatus of claim 31, further comprising: The device, wherein the plurality of tines are formed from a distal portion of the catheter body. (Appendix 35) 35. The apparatus of any one of claims 31 to 34, the funnel further comprising one or more circumferential supports extending circumferentially around one or both of the inner and outer funnel surfaces to restrain the outer periphery of the funnel. (Appendix 36) 36. The apparatus of claim 35, The device, wherein the one or more circumferential supports comprise one or more of a yarn, a wire, a suture, and a thread. (Appendix 37) 36. The apparatus of claim 35, The device, wherein the one or more circumferential supports comprise a suture material. (Appendix 38) 38. The apparatus of any one of claims 35 to 37, the one or more circumferential supports connecting the inner funnel surface to the outer funnel surface. (Appendix 39) 39. The apparatus of any one of claims 35 to 38, The apparatus, wherein the one or more circumferential supports extend helically around the funnel. (Appendix 40) 40. The apparatus of any one of claims 31 to 39, 10. The apparatus of claim 9, wherein each tine of the plurality of tines is folded back upon itself. (Appendix 41) 41. The apparatus of any one of claims 31 to 40, The device, wherein each of the plurality of tines is connected to a circumferentially adjacent tine. (Appendix 42) 42. The apparatus of any one of claims 31 to 41, 10. The device of claim 9, wherein when the funnel is expanded to the packed configuration, the distal end of the funnel extends no more than 5 mm from the distal ends of the plurality of tines. (Appendix 43) 43. The apparatus of claim 42, 10. The device of claim 9, wherein a distal end of the funnel extends no more than 1 mm beyond the distal ends of the plurality of tines when the funnel is expanded to the packed configuration. (Appendix 44) 44. The apparatus of any one of claims 31 to 43, The device, wherein the second flexible tube comprises a braided material. (Appendix 45) 45. The apparatus of any one of claims 31 to 44, The apparatus further comprises a puller extending through the catheter lumen and having a distal end coupled to the first end of the second flexible tube. (Appendix 46) 46. ​​The apparatus of any one of claims 31 to 45, the funnel is shaped so that the inner funnel surface has an outer diameter that is smaller than the inner diameter of the outer funnel surface, thereby forming a space between the inner and outer funnel surfaces, and the plurality of tines are disposed in the space. (Appendix 47) 1. A thrombus removal device, comprising: an everting support catheter having an expandable funnel at a distal end of a flexible elongate catheter body, the funnel comprising: a first flexible tube made of a braided or woven material that is everted upon itself to form an inner funnel surface and an outer funnel surface, the inner funnel surface defining an interior of the funnel that communicates with a lumen of the catheter that extends through the catheter body; a plurality of support tines extending distally from the distal end of the catheter body between the inner funnel surface and the outer funnel surface, the inner funnel surface and the outer funnel surface each configured to slide axially relative to the support tines; one or more circumferential supports extending circumferentially around one or both of the inner and outer funnel surfaces to restrain the outer periphery of the funnel; a second flexible tube made of a braided or woven material extending distally along at least a portion of the outer surface of the catheter body and along the outer funnel surface, and turning back into the interior of the funnel and into the catheter lumen at the distal end of the funnel. (Appendix 48) 48. The apparatus of claim 47, the one or more circumferential supports connecting the inner funnel surface to the outer funnel surface. (Appendix 49) 1. A thrombus removal system comprising: an eversion support catheter having an elongated flexible catheter body, a catheter lumen, and an expandable funnel at a distal end of the catheter body, the distal end of the funnel defining an opening communicating with the interior of the funnel and the catheter lumen, respectively; a first flexible tube made of a braided or woven material extending distally along at least a portion of the outer surface of the catheter body and the outer surface of the funnel, at least a portion of the first flexible tube everting into the interior of the funnel and into the catheter lumen at a distal end of the funnel; a tear-away sleeve extending over the first flexible tube and at least a distal portion of the everting support catheter, the tear-away sleeve configured to be removed from over the first flexible tube by tearing along the length of the tear-away sleeve when the everting support catheter and the first flexible tube are loaded into a delivery catheter. (Appendix 50) 49. The system of claim 49, The system further includes a loading sleeve, wherein a distal portion of the eversion support catheter is configured to be loaded into the loading sleeve with the funnel restrained in the collapsed configuration. (Appendix 51) 51. The system of claim 50, The system further comprises a delivery catheter, wherein the loading sleeve is configured to be inserted into a proximal end of the delivery catheter, and the everting support catheter and the first flexible tube extend distally within the delivery catheter. (Appendix 52) 52. The system of claim 49, further comprising: The system further includes a second flexible tube made of a braided or woven material configured to be attached to the everting support catheter. (Appendix 53) 53. The system of any one of claims 49 to 52, The system further comprises a puller disposed within the catheter lumen, one end of the first flexible tube being coupled to the puller. (Appendix 54) 54. The system of claim 49, further comprising: and a stopper disposed on a proximal end region of an outer surface of the catheter body, the stopper configured to prevent the first flexible tube from extending beyond an outer surface of the catheter body proximal to the stopper. (Appendix 55) 55. The system of any one of claims 49 to 54, The system further includes an elastic cuff disposed on the proximal end of the first flexible tube. (Appendix 56) 56. The system of any one of claims 49 to 55, The system further comprising a lock configured to secure the everting support catheter to the delivery catheter. (Appendix 57) 1. A thrombus removal system comprising: an eversion support catheter having an elongated flexible catheter body, a catheter lumen, and an expandable funnel at a distal end of the catheter body, the distal end of the funnel defining an opening communicating with the interior of the funnel and the catheter lumen, respectively; a first flexible tube made of a braided or woven material extending distally along at least a portion of the outer surface of the catheter body and the outer surface of the funnel, at least a portion of the first flexible tube everting into the interior of the funnel and into the catheter lumen at a distal end of the funnel; a loading sleeve into which a distal portion of the everting support catheter is loaded with the funnel restrained in a collapsed configuration, the loading sleeve including a tear line configured to disassemble and remove the loading sleeve from over the everting support catheter. (Appendix 58) 58. The system of claim 57, the system further comprising a tear sleeve extending over the first flexible tube and at least a distal portion of the everting support catheter, the tear sleeve configured to be removed from over the first flexible tube by tearing along the length of the tear sleeve when the everting support catheter and the first flexible tube are loaded into a delivery catheter. (Appendix 59) 59. The system of claim 58, The system, wherein the loading sleeve is configured to be inserted into the proximal end of the delivery catheter, and the everting support catheter and the first flexible tube extend distally within the delivery catheter. (Appendix 60) 60. The system of any one of claims 57 to 59, The system further includes a second flexible tube made of a braided or woven material configured to be attached to the everting support catheter. (Appendix 61) 61. The system of any one of claims 57 to 60, The system further comprises a puller disposed within the catheter lumen, one end of the first flexible tube being coupled to the puller. (Appendix 62) 62. The system of claim 57, further comprising: and a stopper disposed on a proximal end region of an outer surface of the catheter body, the stopper configured to prevent the first flexible tube from extending beyond an outer surface of the catheter body proximal to the stopper. (Appendix 63) 63. The system of any one of claims 57 to 62, The system further includes an elastic cuff disposed on the proximal end of the first flexible tube. (Appendix 64) 64. The system of any one of claims 57 to 63, The system further comprising a lock configured to secure the everting support catheter to the delivery catheter.

Claims

1. 1. A thrombus removal device, comprising:

1. An eversion support catheter having an expandable funnel at a distal end of a flexible elongate catheter body, the funnel comprising: a first flexible tube made of a braided or woven material that is inverted to form an inner funnel surface and an outer funnel surface, the inner funnel surface defining an interior of the funnel that communicates with a lumen extending through the flexible elongate catheter body; an eversion support catheter comprising: a plurality of longitudinal struts extending distally from the distal end of the flexible elongate catheter body between the inner funnel surface and the outer funnel surface, the inner funnel surface and the outer funnel surface each configured to slide axially relative to the longitudinal struts; a second flexible tube made of a braided or woven material that extends along at least a portion of the exterior surface of the flexible elongate catheter body and along the surface of the outer funnel, and that turns into the interior of the funnel and into the lumen at the distal end of the funnel.

2. 10. The apparatus of claim 1, the funnel further comprising one or more circumferential supports extending circumferentially around one or both of the inner and outer funnel surfaces to restrain the outer periphery of the funnel.

3. 3. The apparatus of claim 2, The device, wherein the one or more circumferential supports comprise one or more of threads, wires, sutures, and yarns.

4. 3. The apparatus of claim 2, The device, wherein the one or more circumferential supports comprise suture material.

5. 3. The apparatus of claim 2, The apparatus, wherein the one or more circumferential supports extend helically around the funnel.

6. 3. The apparatus of claim 2, 10. The device, wherein each of the plurality of longitudinal struts has a distal end, and wherein one of the one or more circumferential supports is positioned at or near the distal end of the longitudinal strut.

7. 7. The device according to any one of claims 2 to 6, the one or more circumferential supports connecting the inner funnel surface to the outer funnel surface.

8. 7. The device according to any one of claims 1 to 6, The apparatus, wherein the first flexible tube comprises a woven material.

9. 7. The device according to any one of claims 1 to 6, The device, wherein the plurality of longitudinal struts are formed from a distal portion of the flexible elongate catheter body.

10. 7. The device according to any one of claims 1 to 6, The device, wherein each longitudinal strut of the plurality of longitudinal struts is folded back upon itself to form a blunt or rounded distal end.

11. 11. The apparatus of claim 10, The device further comprising a filament threaded through a distal end of the plurality of longitudinal struts, the distal end of the plurality of longitudinal struts being folded back.

12. 7. The device according to any one of claims 1 to 6, 10. The apparatus of claim 9, wherein each longitudinal strut of the plurality of longitudinal struts is connected to a circumferentially adjacent longitudinal strut.

13. 7. The device according to any one of claims 1 to 6, The device, wherein the second flexible tube comprises a braided material.

14. 7. The device according to any one of claims 1 to 6, The apparatus further comprising a puller extending through the lumen and having a distal end coupled to the first end of the second flexible tube.

15. 7. The device according to any one of claims 1 to 6, the funnel is shaped so that the inner funnel surface has an outer diameter that is smaller than the inner diameter of the outer funnel surface, thereby forming a space between the inner and outer funnel surfaces in which the plurality of longitudinal struts are disposed.

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