Flip thrombectomy device and method of using the thrombectomy device

Abstract

The present invention describes a mechanically flipping tube device that can be used to remove a clot (e.g., thrombectomy), which includes a flipping support catheter and a flexible tube, wherein the flipping support catheter has an expandable funnel-shaped distal end and the flexible tube is capable of continuously flipping over the funnel-shaped distal end and flipping into the inner cavity of the flipping support catheter.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] 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 on September 10, 2018, which is incorporated herein by reference in its entirety.

[0003] Incorporated by Reference

[0004] 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.

[0005] field

[0006] The devices and methods described herein relate to mechanical removal of objects from the body. In particular, mechanical thrombectomy devices and methods are described herein.

[0007] background

[0008] Many vascular problems stem from insufficient blood flow through the blood vessels. One reason for insufficient or abnormal blood flow is a blockage within a blood vessel, called a blood clot or thrombus. Thrombosis can occur for a variety of reasons, including after a trauma such as surgery or for other reasons. For example, a large portion of the more than 1.2 million heart attacks in the United States are caused by blood clots (thrombi) that form within the coronary arteries. It is often desirable to remove tissue from the body in the least invasive way possible so as not to damage other tissues. For example, removing tissue, such as a blood clot, from a patient's vasculature can improve the patient's condition and quality of life.

[0009] Mechanical thrombectomy devices may be particularly advantageous. There is a clear need for thrombectomy devices, and in particular mechanical thrombectomy devices that can be easily and accurately delivered (often invasively) through anatomical structures in the peripheral and central vasculature and then reliably deployed to remove clotted material. In addition, there is a need for devices that are simple and intuitive to operate.

[0010] Finally, there is a clear need for a mechanical thrombectomy device that can have a low profile but can be inserted into a relatively large diameter vessel. Therefore, this article describes devices (apparatus, systems, and kits) and methods of use thereof that can address the above needs and problems.

[0011] Overview of the Disclosure

[0012] Mechanical thrombectomy devices (equipment, systems, etc.), as well as methods of using and forming them, are described herein. These devices may also be referred to as flip-over mechanical thrombectomy devices and / or flip-over tube thrombectomy devices. In particular, described herein is a flip-over tube thrombectomy device that can be deployed in even very large blood vessels in order to effectively ingest one or more large clots. For example, the device described herein may be configured to provide high traction efficiency so as to utilize a flexible tube (e.g., a tractor tube) to ingest and remove even longer and large-diameter clots, for example, greater than 10 mm in length and / or greater than 5 mm in diameter, in a catheter having a smaller or much smaller diameter (e.g., 5 mm, 4 mm, 3 mm, 2 mm, etc.). In some variations, the flexible tube may be longer than 5 times the length of the clot (e.g., optionally, a tractor tube longer than 6, 7, or 8 times is required).

[0013] Specifically, the device described herein may include an expandable funnel located at the end of the flip support catheter, and a flexible tube (e.g., a tractor tube or a simple tractor) is flipped over the funnel to flip. The flexible tube may be a knitted or woven material. The flexible tube may generally have a first end, which is connected to the distal region of the retractor (which may be an elongated wire, tube, cannula, etc.), and the flexible tube may be arranged to flip over the distal end of the flip support catheter at the funnel, so that when the inner (flipped) portion of the flexible tube is pulled into the funnel, the outer portion of the flexible tube extends proximally over the flip support catheter, compressing and removing fluid from the clot held (e.g., caught) by the flexible tube, and pulling the flipped flexible tube into the flip support catheter until the entire clot is captured, compressed and pulled into the external catheter. By using a flip support catheter including an expandable funnel at the distal end, the configuration of the device described herein is particularly suitable for grabbing and removing clots, and particularly large diameter clots. The collapsible / expandable funnel can be configured to operate by pulling the flexible tube into the inversion support conduit so that it is flipped into the inversion support conduit to apply a compressive force to capture the clot. The collapsible / expandable funnel can be configured to present a fully expanded, locked (e.g., "stuck") configuration when the flexible tube applies a lateral compressive force on the distal surface of the funnel. In addition, the funnel can include an opening (described herein as having a porous structure), and when the clot moves into the cavity of the narrower diameter of the inversion support conduit and compresses the clot, the fluid squeezed out of the clot can flow out of the funnel laterally through the opening. For example, when the clot is compressed, the opening that allows the fluid to leave the funnel wall laterally through the collapsible / expandable funnel (which can be referred to as an expandable funnel herein) can also prevent clot embolism or jamming.

[0014] In general, any of the devices (e.g., systems) described herein may include: an inverted support catheter having an elongated and flexible body, the inverted support catheter having an expandable funnel at the distal end of the elongated and flexible body, wherein at the proximal end of the expandable funnel (e.g., adjacent to the elongated and flexible body), at least a portion of the expandable funnel includes an opening to allow fluid from the clot to flow laterally out of the funnel wall (e.g., the funnel can be porous or partially porous). The device may also include a flexible tube (e.g., a "tractor"). The tractor can be braided or knitted. In some variations, the device includes a retractor in the cavity of the inverted support catheter; a first region of the retractor located at or near the distal end can be attached to the flexible tube. A second region of the flexible tube can extend over the outer surface of the elongated and flexible body. The system can be configured so that when the flexible tube is flipped over the distal end of the expandable funnel, by pulling the flexible tube proximally into the flip support catheter (e.g., by pulling a retractor or pulling on the first end of the flexible tube), the funnel can be fully extended to a locked (stuck) configuration, allowing the flexible tube to flip and flip over the open distal end (e.g., distal edge) of the expandable funnel. The flipping motion of the flexible tube and the structure of the flexible tube (e.g., braiding, knitting, etc.) can capture the clot and drag the clot into the cavity of the flip support catheter, and when the clot is pulled into the cavity, the clot is compressed and fluid is removed from the clot. 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.

[0015] In any of these devices, a delivery catheter (also referred to herein as an intermediate catheter) can be used to assist in deploying the inverted support catheter and flexible tube assembly to an area of ​​the vascular system that includes a clot or more than one clot to be removed. For example, the system can include: an intermediate catheter; an inverted support catheter within the intermediate catheter, the inverted support catheter having an elongated and flexible body, the inverted support catheter having an expandable funnel at the distal end of the elongated and flexible body, the expandable funnel having a porous region at the proximal end of the elongated and flexible body adjacent to the expandable funnel; a retractor within the inverted support catheter lumen; and a braided flexible tube having a first region and a second region, the first region being attached to the retractor located within the inverted support catheter, the second region extending over the outer surface of the elongated and flexible body, wherein the flexible tube inverts over the distal end of the expandable funnel, further wherein the flexible tube is configured to be pulled proximally into the inverted support catheter by pulling the retractor proximally so that when the flexible tube is pulled into the inverted support catheter, the second region inverts and inverts over the distal end of the expandable funnel.

[0016] Any of these systems can include an inner diameter of a second region of the flexible tube extending above the outer diameter of the elongated and flexible body, the inner diameter being greater than the maximum outer diameter of the expandable funnel in the expanded configuration. Any of these systems can have a base region of the expandable funnel adjacent to the distal end of the elongated and flexible body that is porous. For example, the expandable funnel can include a circumferential porous region at the base of the expandable funnel adjacent to the distal end of the elongated and flexible body.

[0017] 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 elongated and flexible body, and / or a maximum outer diameter that is less than about 8 mm.

[0018] The expanded configuration may have a minimum outer diameter greater than about 2 times the outer diameter of the elongate and flexible body. For example, the expanded configuration may have an outer diameter between about 2 mm and about 26 mm.

[0019] In any of the systems described herein, the flexible tube may include a knitted tube. In some variations, the flexible tube may be formed from a braided material or sheet (e.g., laser cut). The tube may be formed from strands or filaments (e.g., monofilaments or multiple filaments). For example, the flexible tube may include a knitted tube having more than 10 coils for each cross section through the knitted tube along the long axis of the knitted tube.

[0020] Generally speaking, the expandable funnel may be formed from sheet, woven, braided and / or knitted material and may include one or more supports (arms, struts, etc.). For example, the expandable funnel may be a mesh that turns over on itself at the distal end of the expandable funnel.

[0021] In some variations, the expandable funnel includes a plurality of longitudinal tines continuous with the elongated and flexible body. The expandable funnel may be self-expanding (e.g., biased to at least partially open); alternatively or additionally, the expandable funnel may be configured to expand when the first region of the flexible tube is pulled proximally. In some variations, the expandable funnel may be configured to be self-expanding and achieve a self-expanding configuration in an unconstrained configuration.

[0022] Generally, the expandable funnel is integrated into the rest of the inversion support catheter, and they form a part of the catheter. Therefore, the interior of the expandable funnel is generally in fluid communication with the cavity of the rest of the catheter, and the catheter cavity can include the interior of the funnel. Similarly, the outer surface of the catheter body includes and surrounds the outer surface of the funnel, unless the context otherwise dictates.

[0023] Any of these devices may include a lubricated sleeve over at least a portion of the expandable funnel. For example, the lubricated sleeve may be over a distal region of the interior of the expandable funnel. In some variations, the lubricated sleeve extends over the distal end of the funnel. In some variations, the lubricated sleeve includes one or more openings; these openings may be in a proximal portion (e.g., near the base of the expandable funnel).

[0024] Typically, the expandable funnel can be any suitable size in the expanded configuration, such as having a maximum outer diameter between 2-26 mm. For example, the expanded configuration can 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.). The user can typically select the maximum size of the inverted support catheter to be about 60% (e.g., about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, etc.) or greater of the inner diameter of the blood vessel in which the device will be used (e.g., alternatively or additionally, the outer diameter of the clot to be removed).

[0025] Any of the devices (e.g., systems) described herein may include an intermediate catheter at least partially surrounding the inversion support catheter and / or a retractor located in the cavity of the inversion support catheter. For example, the second end of the flexible tube can be coupled to the distal region of the retractor. The first region is attached to the vicinity of the distal end of the retractor.

[0026] In general, the expandable funnel described herein can be configured to withstand sufficient tension to allow the flexible tube to flip, flip and pull the clot (even a very large diameter clot) into the funnel, compress the clot (e.g., remove most of the fluid in the clot) and pull the compressed clot into the flip support catheter body. For example, the expandable funnel can be configured to withstand a compression force greater than about 500g (e.g., greater than about 600g, 700g, 750g, 800g, 900g, 1000g, 1100g, 1200g, 1300g, 1400g, 1500g, etc.), and will not collapse when the compression force is directed axially (e.g., toward the proximal side). For example, the expandable funnel can be configured to withstand a compression force greater than 1200g without collapsing. In some variations, the compression force can cause the funnels to lock together or stack together, particularly when the funnels are made of braided, knitted or braided materials. For example, for a braided funnel, the compressive force can axially jam the braid of the funnel material to increase the braid angle in the distal (wider) region, thereby increasing the column strength of the funnel.

[0027] For example, a thrombectomy system may include: a flip support catheter having an elongated and flexible catheter body, a catheter cavity and an expandable funnel disposed at the distal end of the catheter body, wherein the distal end of the funnel defines a distal opening, which is respectively connected to the interior of the funnel and the catheter cavity; and a flexible tube, which is flipped over the distal end of the funnel so that the flexible tube has a first region and a second region, the first region is at least partially disposed inside the funnel, and the second region extends at least partially over the outside of the funnel, wherein the flexible tube is constructed to be pulled proximally into the catheter cavity by pulling the first region proximally, so that when the flexible tube is pulled into the catheter cavity, the second region flips over the distal end of the funnel.

[0028] In some embodiments, a thrombectomy system may include: a flip support catheter having an elongated and flexible catheter body, a catheter lumen, and an expandable funnel disposed at the distal end of the catheter body, wherein the distal end of the funnel defines a distal opening that is connected to the interior of the funnel and the catheter lumen, respectively, and wherein at least a proximal portion of the funnel adjacent to the catheter body includes an opening configured to allow fluid to pass therethrough; a retractor disposed within the catheter lumen; and a flexible tube formed of a knitted or braided material that flips over the distal end of the funnel and has a first region and a second region, the first region being attached to the retractor and the second region extending at least partially over an outer surface of the funnel, wherein the flexible tube is configured to be pulled proximally into the catheter lumen by pulling the retractor proximally so that the second region of the flexible tube passes through the interior of the funnel and enters the catheter lumen, respectively.

[0029] A thrombectomy system may include: an inverted support catheter having an elongated and 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 that communicates with an interior of the funnel and the catheter lumen, respectively, and wherein at least a proximal end of the funnel adjacent to the catheter body includes an opening configured to allow fluid to pass therethrough; and a knitted flexible tube inverted over the distal end of the funnel and having a first region at least partially disposed within the interior of the funnel and a second region extending at least partially over an exterior of the funnel, wherein the flexible tube is configured to be proximally pulled into the catheter lumen by proximally pulling the first region of the flexible tube so that when the flexible tube is pulled into the interior of the funnel and the catheter lumen, respectively, the second region of the flexible tube inverts over the distal end of the funnel, and wherein the funnel is configured to proximally pull the first region of the flexible tube to apply an axial load on the funnel, the axial load expanding the funnel into an expanded and stuck configuration.

[0030] The present invention also describes a method of removing a clot from a blood vessel using any of the devices described herein. For example, a method of removing a clot from a blood vessel may include: advancing a flip tube device through the blood vessel until the distal end of the flip tube device is close to the clot, wherein the flip tube device includes a flip support catheter having an expandable funnel at the distal end of an elongated and flexible body, and a flexible tube having a first region and a second region, the first region being within the flip support catheter and the second region extending over an outer surface of the flip support catheter; expanding the expandable funnel from a collapsed configuration to an expanded configuration within the blood vessel; and proximally pulling the first region of the flexible tube so that the flexible tube flips over the distal end of the expandable funnel of the flip support catheter so that the flexible tube flips over the distal end of the expandable funnel to capture the clot and pull the clot proximally into the flip support catheter, wherein pulling the clot proximally into the flip support catheter includes compressing the clot and causing fluid in the clot to be ejected laterally out of the flip support catheter.

[0031] For example, a method for removing a clot from a blood vessel may include: advancing a flip tube device through the blood vessel until the distal portion of the flip tube device is located near the clot, wherein the flip tube device includes a flip support catheter having an elongated and flexible catheter body, an internal catheter cavity and an expandable funnel arranged at the distal end of the catheter body, wherein the distal end of the funnel defines an opening, which is respectively connected to the interior of the funnel and the catheter cavity, and the flip tube device also includes a flexible tube, which is flipped over the distal end of the expandable funnel and has a first region and a second region, the first region is at least partially arranged inside the funnel, and the second region extends at least partially above the outer surface of the funnel; expanding the funnel from a collapsed transport configuration to an expanded configuration near the clot in the blood vessel; and pulling the first region of the flexible tube proximally so that the second region of the flexible tube flips over the distal end of the funnel, so that the flexible tube captures the clot and pulls the clot proximally into the interior of the corresponding funnel and the catheter cavity.

[0032] Any of the methods of removing a clot from a blood vessel described herein may include using any of these devices. For example, a method of removing a clot from a blood vessel may include: advancing a flip tube device through the blood vessel until the distal end of the flip tube device is proximate to the clot, wherein the flip tube device includes a flip support catheter having an expandable funnel at the distal end of an elongated and flexible body, and a flexible tube having a first region and a second region, the first region being within the flip support catheter and the second region extending over an outer surface of the flip support catheter; expanding the expandable funnel from a collapsed configuration to an expanded configuration within the blood vessel; and proximally pulling the first region of the flexible tube so that the flexible tube flips over the distal end of the expandable funnel of the flip support catheter so that the flexible tube flips over the distal end of the expandable funnel to capture the clot and pull the clot proximally into the flip support catheter, wherein pulling the clot proximally into the flip support catheter includes compressing the clot and causing fluid in the clot to be ejected laterally out of the flip support catheter.

[0033] As described above, any of these methods can include selecting the size of the inversion tube device based on the size of the blood vessel. Thus, the user can select from a plurality of different sized intermediate conduits and / or flexible tubes based on the size of the blood vessel and / or clot.

[0034] In any of these methods, the expansion can include expanding the outer diameter of the expandable funnel to a diameter that is at least 1 / 3 greater than the outer diameter of the clot (e.g., greater than 33%, greater than 40%, greater than 50%, greater than 60%, greater than 70%, greater than 80%, greater than 90%, etc. of the clot OD and / or vessel ID). For example, the expansion can include expanding the outer diameter of the expandable funnel to a diameter that is at least 50% greater than the outer diameter of the clot.

[0035] In some variations, pulling the clot proximally may comprise applying a force between 500 g and 3000 g.

[0036] In some variations, expanding the expandable funnel may include allowing the expandable funnel to self-expand in the blood vessel, and / or expanding the expandable funnel may include applying an axial compressive force on the expandable funnel by pulling the first region of the flexible tube proximally. By applying an axial compressive force on the expandable funnel by pulling the flexible tube proximally, the self-expanding funnel may further expand. For example, in some variations, the expandable funnel may be configured to self-expand into a self-expanding configuration when unconstrained, such as when released from a constrained configuration within, for example, a second guide catheter, a second intermediate catheter, etc.

[0037] Any of these methods may include removing the flexible tube from the inverted support catheter and reinserting a new flexible tube into the inverted support catheter.

[0038] For example, systems are described herein, including thrombectomy systems. Any of these systems may include: a flip support catheter having an elongated and flexible body, the flip support catheter having an expandable funnel at the distal end of the elongated and flexible body; and a flexible tube having a first region within the flip support catheter and a second region extending over an outer surface of the elongated and flexible body, wherein the flexible tube flips over the distal end of the expandable funnel, further wherein the flexible tube is configured to be pulled proximally into the flip support catheter by pulling the first region proximally, so that when the flexible tube is pulled into the flip support catheter, the second region flips and flips over the distal end of the expandable funnel.

[0039] Any of these systems may include: a flip support catheter having an elongated and flexible body, the flip support catheter having an expandable funnel at the distal end of the elongated and flexible body, wherein at least the proximal end of the expandable funnel adjacent to the elongated flexible body includes an opening configured to allow fluid to pass therethrough; a retractor in the cavity of the flip support catheter; and a flexible tube formed of a knitted or braided material, the flexible tube having a first region and a second region, the first region being attached to the retractor within the flip support catheter and the second region extending over the outer surface of the elongated and flexible body, wherein the flexible tube flips over the distal end of the expandable funnel, and further, wherein the flexible tube is configured to be pulled proximally into the flip support catheter by pulling the retractor proximally so that when the flexible tube is pulled into the flip support catheter, the flexible tube flips and flips over the distal end of the expandable funnel.

[0040] For example, a system may include: a flip support catheter having an elongated and flexible body, the flip support catheter having an expandable funnel at the distal end of the elongated and flexible body, further, wherein at least the proximal end of the elongated and flexible body adjacent to the expandable funnel includes an opening configured to allow fluid to pass therethrough; a retractor in the cavity of the flip support catheter; and a knitted flexible tube having a first region and a second region, the first region being attached to the retractor within the flip support catheter and the second region extending over the outer surface of the elongated and flexible body, wherein the flexible tube is flipped over the distal end of the expandable funnel, further, wherein the flexible tube is configured to be pulled proximally into the flip support catheter by pulling the retractor proximally, so that when the flexible tube is pulled into the flip support catheter, the flexible tube flips and flips over the distal end of the expandable funnel to apply an axial load on the funnel, thereby expanding the funnel into an expanded configuration.

[0041] In any of these systems, the inner diameter of the second region of the flexible tube extending over the outer diameter of the elongated and flexible body can be less than the maximum outer diameter of the expandable funnel in the expanded configuration. Thus, the flexible tube can be expanded when it is pulled from the narrower relaxed diameter over the more proximal body of the inversion support catheter over the funnel portion of the inversion support catheter. In any of the devices described herein, the flexible tube can be biased so that the inversion portion (when in the inversion support catheter) self-expands (or is shaped to expand), for example, having an outer diameter that is 40% or more (e.g., 50% or more, 60% or more, 70% or more, 75% or more, 80% or more, etc.) of the inner diameter of the elongated body of the inversion support catheter.

[0042] As described above, the base region of the expandable funnel adjacent to the distal end of the elongated and flexible body may include an opening (e.g., which may be referred to as porous) that is configured to allow fluid to pass through. In some variations, the opening or hole may be formed by an opening between one or more strands that form the braided funnel body. For example, the expandable funnel may include a circumferential porous region located at the base of the distal end of the elongated and flexible body adjacent to the expandable funnel.

[0043] The collapsed configuration of the expandable funnel may have a maximum outer diameter that is less than 0.3 times (e.g., 30%) of the outer diameter of the elongated and flexible body. In some arrangements, 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 of the outer diameter of the elongated and flexible body of the inversion support catheter (e.g., the average outer diameter of the inversion support catheter adjacent to the funnel or the region thereof), etc. In some variations, the collapsed configuration has a maximum outer diameter that is less than 8 mm.

[0044] In some variations, the expanded configuration may have a minimum outer diameter greater than 2 times (e.g., greater than 2.5 times, greater than 3 times, greater than 3.5 times, etc.) the outer diameter of the elongated and flexible body. The maximum outer diameter is typically the diameter of the distal side of the funnel, which may also be referred to as the distal opening or distal edge. For example, the expanded configuration may have an outer diameter between 2 mm and 26 mm.

[0045] As described above, generally, the flexible tube may include a knitted tube; for example, the flexible tube may be constructed as a knitted tube having more than 10 loops for each cross section through the knitted tube along the long axis of the knitted tube.

[0046] As described in more detail below, the expandable funnel may include a plurality of longitudinal tines (e.g., struts) that are continuous with the elongated and flexible body. These tines may extend in a distal (e.g., longitudinal) direction and may be covered, for example, by a mesh material (e.g., in some variations, a woven or knitted material) that folds itself to form an inner surface within the mouth of the funnel and an outer surface on the outside of the funnel. The tines may be inserted between the inner and outer surfaces and may move longitudinally relative to the inner and outer surfaces. For example, the expandable funnel may include a mesh that flips itself over at the distal end of the expandable funnel.

[0047] Typically, the funnel may be biased to at least partially self-expand.In some variations, the expandable funnel is configured to fully expand when the first region of the flexible tube is pulled proximally.

[0048] In any of the devices described herein, a lubricating sleeve may be included over at least a portion of the expandable funnel; for example, over the inner surface and / or outer surface, and / or over the everted distal region.

[0049] The funnel can be configured to open to any suitable diameter. For example, in some variations, the expandable funnel can have a maximum outer diameter greater than 16 mm.

[0050] Any of the devices described herein may include a retractor (rod, catheter, wire, etc.) in the cavity of the flip support catheter, wherein the second end of the flexible tube is connected to the distal region of the retractor; in some variations, the first region of the flexible tube can be attached near the distal end of the retractor.

[0051] In some variations, a thrombectomy device may include: an inverted support catheter having an expandable funnel at a distal end of a flexible elongated body, the expandable funnel comprising: a funnel surface formed by a first tube of a knitted or braided material that inverts upon itself to form an inner funnel surface and an outer funnel surface, and a plurality of support tines extending distally between the inner funnel surface and the outer funnel surface, wherein the funnel surface is configured to slide axially relative to the plurality of support tines; and a second flexible tube made of a knitted or braided material that extends distally along an outer surface of the inverted support catheter and inverts over the expandable funnel and into a lumen of the inverted support catheter, wherein the expandable funnel is configured to expand to a jammed configuration when the second flexible tube is proximally pulled into the inverted support catheter. As described above, the funnel surface may include a braided material. In some variations, the funnel surface has a braid angle greater than 90 degrees in the jammed configuration.

[0052] Therefore, in some variations of the expandable funnel described herein, the expandable funnel can be configured to present a jammed configuration when an axial compression force is applied, such as by pulling a tractor (e.g., a flexible tube) proximally so that the tractor flips and flips over the funnel from the outside of the inversion support catheter and enters the cavity of the inversion support catheter. The jammed configuration can lead to a compressed configuration in which the expandable funnel is harder than in an unjammed configuration. The jammed configuration can also have a greater column strength. In variations in which the wall of the expandable funnel is formed by a braided material, the jammed configuration can be produced by a braid with a maximum braiding angle, which can be referred to as a jamming angle.

[0053] As described above, a plurality of tines can be formed (e.g., cut, such as laser cutting) by a flexible elongated body. The expandable funnel may also include one or more circumferential supports that extend radially around the funnel surface and limit the outer diameter of the expandable funnel. One or more circumferential supports may include filaments, such as one or more of yarns, silk threads, sutures, and sewing threads. For example, one or more circumferential supports may include suture material. One or more circumferential supports may connect the inner funnel surface to the outer funnel surface. One or more circumferential supports may extend spirally around the expandable funnel as one or more filaments in some cases.

[0054] In some variations, the tine itself is folded back and can be crimped together. In some variations, each tine is connected by a filament, for example, at the distal region. This filament can be referred to as a tine filament and can disperse force between different tines. A variety of different tine filaments can be used. In some variations, the tine filament can be fixed to the tine from the distal end of the tine near the distal end (e.g., within the range of 1mm, 2mm, 3mm, etc.). In some variations, the tine filament is fixed in a cavity formed by the folded body of the tine.

[0055] 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 the stuck and expanded configurations. For example, the meshes forming the outer surface and the inner surface may be fixed to each other but not to the tines, and when the expandable funnel is expanded to the stuck configuration, the mesh may extend 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 plurality of tines to the distal side of the tines in the expanded configuration. For example, when the expandable funnel is expanded to the stuck configuration, the funnel surface may extend 1 mm or less from the distal ends of the plurality of tines.

[0056] As described above, the second flexible tube can be formed of a knitted material. In addition, any of the devices described herein can include a retractor that extends through the inversion support catheter and is coupled to the first end of the second flexible tube at a distal end. The funnel surface is shaped so 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 plurality of tines between the inner surface and the outer surface.

[0057] For example, the thrombectomy device described herein includes: an inverted support catheter having an expandable funnel at the distal end of a flexible elongated body, the expandable funnel including: a funnel surface, the funnel surface being formed by a first tube of a woven material, the first tube itself being inverted to form an inner funnel surface and an outer funnel surface, a plurality of support tines, the support tines extending distally between the inner funnel surface and the outer funnel surface, wherein the funnel surface is constructed to slide axially relative to the plurality of support tines, and one or more circumferential supports extending radially around the funnel surface and limiting the maximum outer diameter of the expandable funnel; and a second flexible tube made of a knitted or woven material, the second flexible tube extending distally along the outer surface of the inverted support catheter, and when the first end of the second flexible tube is pulled proximally into the inverted support catheter, it is inverted over the expandable funnel and enters the expandable funnel and into the cavity of the inverted support catheter.

[0058] A thrombectomy device may include: an inverted support catheter having an expandable funnel at the distal end of a flexible elongated body, the expandable funnel including: a funnel surface, the funnel surface being formed by a first tube made of a woven material, the first tube inverting itself to form an inner funnel surface and an outer funnel surface, a plurality of support tines, the support tines extending distally between the inner funnel surface and the outer funnel surface, wherein the funnel surface is constructed to slide axially relative to the plurality of support tines, and one or more circumferential supports extending radially around the funnel surface and limiting the maximum outer diameter of the expandable funnel and connecting the inner funnel surface to the outer funnel surface; and a second flexible tube made of a knitted or woven material, the second flexible tube extending distally along the outer surface of the inverted support catheter, and inverting over the expandable funnel and entering the expandable funnel and into the cavity of the inverted support catheter when the first end of the second flexible tube is pulled proximally into the inverted support catheter.

[0059] In some variations, a thrombectomy device may include: an inverted 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 knitted or braided material that inverts 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 extending through the catheter body, and 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, wherein the respective inner funnel surface and the outer funnel surface are configured to slide axially relative to the support tines; and a second flexible tube made of a knitted or braided material that extends distally along at least a portion of the outer surface of the catheter body and the outer funnel surface, respectively, and inverts over the distal end of the funnel into the interior of the funnel and the catheter lumen, respectively, wherein the funnel shape is configured to expand into a jammed configuration when the second flexible tube is pulled proximally into the catheter lumen.

[0060] The devices described herein can be configured as a kit or system for performing thrombectomy and can be packaged together, including pre-loaded component parts, or sold separately. For example, a thrombectomy system is described herein that can include: a flip support catheter having an elongated and flexible body and an expandable funnel at the distal end of the elongated and flexible body; a flexible tube made of a knitted or braided material extending distally along the outer surface of the flip support catheter and configured to flip over and enter the expandable funnel and enter the cavity of the flip support catheter to expand the expandable funnel; and a tear sleeve extending over the flexible tube and the flip support catheter and configured to be removed from the flexible tube by tearing along the length of the tear sleeve when the flip support catheter and the flexible tube are loaded into a delivery catheter.

[0061] A thrombectomy system may include: a flip support catheter having an elongated and flexible body and an expandable funnel located at the distal end of the elongated and flexible body; a flexible tube made of a knitted or braided material, which extends distally along the outer surface of the flip support catheter and is constructed to flip over the expandable funnel and enter the expandable funnel, and enter the cavity of the flip support catheter to expand the expandable funnel; and a loading sleeve, wherein the distal end of the flip support catheter is loaded into the loading sleeve so that the expandable funnel is constrained in a collapsed configuration, and further, wherein the loading sleeve includes a tear line, which is constructed to separate the loading sleeve for removing the loading sleeve from the flip support catheter.

[0062] In some embodiments, a thrombectomy system may include: a flip support catheter having an elongated and flexible body and an expandable funnel at the distal end of the elongated and flexible body; a flexible tube made of a knitted material extending distally along the outer surface of the flip support catheter and configured to flip over and enter the expandable funnel and enter the cavity of the flip support catheter to expand the expandable funnel; a loading sleeve, wherein the distal end of the flip support catheter is loaded into the loading sleeve so that the expandable funnel is constrained in a collapsed configuration, further wherein the loading sleeve includes a tear line configured to separate the loading sleeve for removing the loading sleeve from the flip support catheter; and a tear sleeve extending over the flexible tube and the flip support catheter and configured to be removed from the flexible tube by tearing along the length of the tear sleeve when the flip support catheter and the flexible tube are loaded into a delivery catheter.

[0063] Thus, any of the systems described herein may include a loading sheath, wherein the distal end of the eversion support catheter is loaded into the loading sheath such that the expandable funnel is constrained in a collapsed configuration.

[0064] Any of these systems may include a delivery catheter, wherein the loading sheath is configured to be inserted into the proximal end of the delivery catheter so that the flip support catheter and the flexible tube made of the knitted or braided material can be driven distally into the delivery catheter.

[0065] Additionally, any of these systems can include a second flexible tube made of a knitted or braided material that is configured to be inserted into the inversion support catheter. Thus, the system can be configured to allow deployment of a second flexible tube that can be configured (e.g., with a loading cannula) for insertion (e.g., by a physician, nurse, medical technician, etc.) and at least partially into the inversion support catheter.

[0066] Any of the invertible support catheters described herein may include a stopper located at a proximal region of the invertible support catheter, the stopper being configured to prevent a flexible tube made of a knitted or woven material from extending proximally over the outer surface of the invertible support catheter beyond the stopper. This may be particularly useful when a flexible tube is installed (e.g., by a user) over the invertible support catheter and inserted into a delivery catheter; even with a tear sleeve, the tear sleeve prevents the flexible tube (e.g., which may be a knitted tube) from being pushed proximally when the invertible support catheter and the flexible tube are pushed distally into the delivery catheter.

[0067] In some variations, the flexible tube may include an elastic cuff on the proximal end of the flexible tube made of a knitted or braided material; the elastic cuff may interact (e.g., engage) with a stop of the rollover support catheter and may prevent it from extending beyond the stop.

[0068] As already described above, the system may include a retractor positioned within the inversion support catheter, wherein the distal end of a flexible tube made of a knitted or braided material is coupled to the retractor.

[0069] In some variations, the system may include a lock configured to lock the inversion support catheter to the delivery catheter. The lock may engage both the delivery catheter and the inversion support catheter so that the two may be moved together (eg, with one hand).

[0070] A thrombectomy system may include: a flip support catheter having an elongated and flexible catheter body, a catheter cavity and an expandable funnel located at the distal end of the catheter body, wherein the distal end of the funnel defines an opening that is respectively connected to the interior of the funnel and the catheter cavity; a first flexible tube made of a knitted or braided material, which extends distally along at least a portion of the outer surface of the catheter body and the outer surface of the funnel, respectively, wherein at least a portion of the first flexible tube flips over the distal end of the funnel and enters the interior of the corresponding funnel and the catheter cavity, respectively; and a tear sleeve that extends over the first flexible tube and at least the distal portion of the flip support catheter, the tear sleeve being constructed to be removed from the first flexible tube by tearing along the length of the tear sleeve when the flip support catheter and the first flexible tube are loaded into a delivery catheter.

[0071] For example, a thrombectomy system may include: a flip support catheter having an elongated and flexible catheter body, a catheter cavity, and an expandable funnel located at the distal end of the catheter body, wherein the distal end of the funnel defines an opening that is connected to the interior of the funnel and the catheter cavity, respectively; a first flexible tube made of a knitted or braided material, which extends distally along at least a portion of the outer surface of the catheter body and the outer surface of the funnel, respectively, wherein at least a portion of the first flexible tube is flipped over the distal end of the funnel and enters the interior of the corresponding funnel and the catheter cavity, respectively; and a loading sleeve, wherein the distal portion of the flip support catheter can be loaded into the loading sleeve, wherein the funnel is confined in a collapsed configuration, and wherein the loading sleeve includes a tear line that is constructed to separate the loading sleeve and remove the loading sleeve from the flip support catheter.

[0072] Although the inverted support catheters with expandable funnels as described herein may be included as part of a device for performing thrombectomy (or atherectomy in some variations), any of these inverted support catheters may be used alone without other components of the system (e.g., a flexible tube). For example, described herein is a support catheter having an expandable funnel at the distal end of a flexible elongated body, the expandable funnel comprising: a funnel surface formed by a first tube of knitted or braided material that inverts upon itself to form an inner funnel surface and an outer funnel surface; and a plurality of support tines extending distally between the inner funnel surface and the outer funnel surface, wherein the funnel surface is configured to slide axially relative to the plurality of support tines.

[0073] As described above, methods of performing atherectomy using any of the devices described herein to remove atheromatous plaques are also described herein. Generally, the flip tube device may include or be used in conjunction with one or more annular cutters, such as an annular stripper or a double ring cutter that can be used to transect atheromatous plaques. (e.g., a MollRing cutter); a stent may then be inserted.

[0074] For example, described herein is a method for atherectomy, comprising: advancing a flip tube device through a blood vessel until the distal end of the flip tube device approaches the atheroma, wherein the flip tube device comprises a flip support catheter having an expandable funnel at the distal end of an elongated and flexible body, the expandable funnel having a collapsed configuration and an expanded configuration, and a flexible tube having a first region and a second region, the first region being within the flip support catheter and the second region extending over the outer surface of the flip support catheter; expanding the expandable funnel from a collapsed configuration to an expanded configuration near the atheroma in the blood vessel; and pulling the first region of the flexible tube proximally to cause the flexible tube to flip over the distal end of the expandable funnel of the flip support catheter, so that the flexible tube flips over the distal end of the expandable funnel, while pushing the flip tube device distally; applying axial shear force to the wall from the moving flexible tube to remove the atheroma from the blood vessel.

[0075] Applying the axial shear force may also include rasp-forming the atheroma with a plurality of protrusions extending from the flexible tube.

[0076] Any of these methods may further include, after the inverted tube device is engaged with the atheroma, advancing the annular cutter (or double annular cutter / stripper) over the inverted tube device and into the atheroma. The method may also include, by withdrawing the second annular cutter proximally, cutting the atheroma with the second annular cutter transverse to the long axis of the blood vessel.

[0077] For example, the devices (e.g., systems, apparatus, etc.) and methods described herein may also be suitable for removing atheromatous plaque material, including performing atherectomy. A device configured as an atherectomy device as described herein may include: a flip support catheter having an elongated and flexible body, the flip support catheter having an expandable funnel (e.g., having a collapsed configuration and an expanded configuration) at the distal end of the elongated and flexible body; and a flexible tube having a first region and a second region, the first region being within the flip support catheter, the second region extending over the outer surface of the elongated and flexible body, wherein the flexible tube flips over the distal end of the expandable funnel, further wherein the flexible tube is configured to be pulled proximally into the flip support catheter by pulling the first region proximally, so that when the flexible tube is pulled into the flip support catheter, the second region flips and flips over the distal end of the expandable funnel. The flexible tube may include atheromatous plaque capture, or a cutting protrusion that may extend from the flexible tube when the flexible tube flips over and enters the funnel. For example, when the flexible tube moves along the outer ramped side of the funnel, the protrusion can extend from the flexible tube to engage the atheroma. In some variations, the flexible tube can reciprocate in the expandable funnel to cut and / or remove the atheroma. BRIEF DESCRIPTION OF THE DRAWINGS

[0079] In particular, the novel features of the present invention are set forth in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by referring to the following detailed description and the accompanying drawings, which set forth illustrative embodiments utilizing the principles of the present invention, wherein:

[0080] Figure 1A-Figure 1C An example of a mechanical tube inversion device that is particularly suitable for small and tortuous vascular anatomy is shown. Figure 1A , the assembled device is shown in a side view, showing the flip support catheter and the flexible outer tube. Figure 1B shows the presence of a clot in a blood vessel Figure 1A The flip tube device. Figure 1C Shows the use of Figure 1A The device removes a clot from a blood vessel by proximally pulling a flexible tube on the outside of a flip support catheter so that the flexible tube flips over the distal end of the flip support catheter and enters the flip support catheter, and the clot is pulled by the flexible tube; the device can be advanced distally.

[0081] Figure 2 is in a large vessel (with a clot diameter greater than 2 times the inner diameter of the inverted support catheter) similar to Figure 1A An example of an inversion tube device is shown. Although a clot can be ingested and removed by an inversion tube device having an inversion support catheter of a narrower diameter, the efficiency of inversion may be low, for example, requiring a flexible tube having approximately 12 times the length of the clot tube to capture the entire clot.

[0082] Figure 3A-3B An example of an inversion tube device is shown, which is suitable for dehydrating the clot (e.g., removing liquid) as the clot is ingested, thereby improving the efficiency of inversion. Figure 3A , the inversion tube device is shown in an undeployed state, within an intermediate (e.g., delivery) catheter; the inversion support catheter includes an expandable funnel at the distal end, over which the flexible tube is inverted. The flexible tube is attached to the distal region of the retractor so that the retractor can be extended distally. Figure 3B middle, Figure 3A The eversion tube device is shown in a deployed configuration, with at least the distal end extending from the intermediate catheter; the expandable funnel at the distal end of the eversion support catheter is in an expanded configuration.

[0083] Figure 4A-4B Another example of an eversion tube device including an expandable funnel is shown, wherein a flexible tube (eg, a knitted tube) is attached to the distal end of a retractor. Figure 4B Shown in deployed configuration Figure 4A An eversion tube device in which an intermediate (eg, delivery) catheter is proximally withdrawn, allowing an expandable funnel at the distal end of the eversion support catheter to expand and the flexible tube to expand.

[0084] Figure 4C is similar to Figure 4A-4C Prototype image of the flip tube device shown.

[0085] Figure 5A-Figure 5B An example of a distal end of an inversion tube device is shown, which includes a funnel at the distal end of an inversion support catheter over which a knitted flexible tube is flipped and inverted. Figure 5A is a top-down perspective view, and Figure 5B It is a side view.

[0086] Figure 6A-6D One example of a prototype inversion support catheter is shown that includes an expandable funnel at the distal end that can be used with an inversion tube device. Fig. 6A The expandable funnel is shown in a collapsed form. Figure 6B An expandable funnel is shown deployed (eg, emerging from an intermediate catheter or a delivery catheter (not shown)). Figure 6C The expandable funnel is shown fully deployed by applying a compressive force along the long axis of the everted support tube. Fig.6D An example of an inversion tube device including an inversion support catheter having a Figure 6A-6C Expandable funnel shown.

[0087] Fig. 7AAn example of an inversion tube device is shown that is configured to dehydrate the clot as the inversion tube device engulfs the clot. Fig. 7A , the inverted tube device is shown next to a 4 mm clot prior to ingestion of the clot. Figure 7B The inversion tube device is shown after the inversion tube device has engulfed a clot, wherein the flexible tube is removed from the inversion support catheter with the expandable funnel.

[0088] Fig. 8A An example of an everting tube device is shown where the inner diameter of the flexible tube has been selected to match the outer diameter of the clot before the everting tube device ingests the clot. Figure 8B A clot is shown after being captured (ingested) by the flexible tube of the eversion tube device.

[0089] Figure 9A-9C The relationship between clot removal efficiency (eg, the length of flexible tubing required to engulf and remove a clot) is shown, showing that clot removal efficiency is improved by a larger outer diameter flexible tubing. Fig.9A An example of an inverted tube device engulfing a clot within a blood vessel is shown. Fig. 9B is a graph showing the length of flexible tubing (knitted flexible tubing) required to ingest a 5 cm clot having an outer diameter (OD) of 15 mm into an eversion support catheter having an inner diameter (ID) of 8 F (eg, less than 2.67 mm). Fig. 9C Examples of various inversion tube devices with different flexible tube ODs are shown.

[0090] Figures 10A-10D An example of an inverted support catheter is shown with an expandable funnel at its distal end.

[0091] Figures 11A-11D An example of an inverted support catheter with an expandable funnel is shown. Fig.11A is a schematic diagram of an inversion support catheter including a funnel including a support frame formed by a distal end region of an elongated inversion support catheter. Fig. 11B is shown cut to form Fig.11A An example of a flip support catheter of a support member is schematically shown in FIG. Fig. 11C is formed by attaching to Fig. 11B An example of a distal funnel of an inversion support catheter formed of a braided material of a frame is shown. Fig.11D yes Fig. 11C An end view of the funnel is shown in FIG.

[0092] Fig.12is an example of a funnel of an inverted support catheter, which is configured to have an axial compressive strength sufficient to resist collapse when an axial compressive force greater than 500 g (e.g., greater than 1 kg, greater than 1.2 kg, greater than 1.5 kg, etc.) is applied. In this example, the axial compressive force can also open the funnel to deploy the funnel, and the axial compressive force can be applied by a flexible tube that is pulled proximally (e.g., pulled) to invert over the distal end of the funnel.

[0093] Figures 13A-13D An example of an inverted support catheter having an expandable funnel lined with a lubricated (eg, Teflon) sleeve is shown. Fig.13A is a schematic diagram of an inversion support catheter including a funnel including a support frame formed by a distal end region of an elongated inversion support catheter and a lubricated sleeve. Fig. 13B For example, Fig.13A An example of a flip support catheter schematically shown in FIG. 1 includes a lubricated sleeve. Fig. 13C Is the inverted support catheter (eg Fig. 13B An example of a distal funnel of an inverted support catheter shown in an expanded configuration. Fig.13D yes Fig. 13C An end view of the funnel is shown in FIG.

[0094] Figure 14A-Figure 14C An example of an expandable funnel of an inversion support catheter is shown, which may include a lubricated sleeve within the mouth of the funnel to reduce pulling forces.

[0095] Fig.15A is an example of a frame cut to form a funnel at the distal end of an inversion support catheter; Fig.15A In the embodiment, the finger formed by cutting the distal end of the catheter is covered by a PTFE membrane in the mouth of the funnel.

[0096] Fig. 15B is an example of a frame cut to form a funnel at the distal end of an inversion support catheter, with curved struts (fingers) forming the funnel area.

[0097] Figures 16A-16D Examples of thrombectomy devices having different sizes are shown, which may be selected by the user based on vessel and / or clot size.

[0098] Figure 17A-17C An example of an inverted tube device that may be used to remove atheroma (eg, atherectomy) is shown.

[0099] Figures 18A-18C A method of removing atheroma using an inverted tube device and a pair of cutting rings is shown.

[0100] Fig.19An example of a portion of a distal end of an inversion support catheter including a plurality of tines is shown.

[0101] Fig. 20A is an example of a plurality of tines of an inverted support catheter having an expandable funnel comprising filaments connecting adjacent tines.

[0102] Fig. 20B yes Fig. 20A Magnified view of the distal end of the tine (filament shown).

[0103] Fig.21A An example of a flexible tube made of a braided material that can form the funnel surface of an expandable funnel of an inverted support catheter; the braided material is inverted on itself and the shape is set (e.g., heat set) so that there is space between the outer funnel surface and the inner funnel surface into which the tines can fit.

[0104] Fig.21B Shows Fig.21A Magnified view of the flexible tube.

[0105] Fig.22A is an example of the expandable funnel of an inverted support catheter in its relaxed state.

[0106] Fig. 22B Shows Fig.22A The expandable funnel is in a fully expanded configuration with compressive stress applied.

[0107] Fig. 22C Shown collapsed and restrained in loading sleeve Fig. 22C Expandable funnel.

[0108] Fig.23 is another example of an expandable funnel that inverts the support catheter.

[0109] Fig.24A One example of an expandable funnel of an eversion support catheter is shown, wherein a flexible tube made of a knitted material extends distally along the outer surface of the eversion support catheter and everts into the eversion support catheter.

[0110] Fig. 24B The fully expanded and jammed funnel body in the expanded configuration is shown when tension is applied to pull the tube made of a knitted or braided material into the inverted support catheter. Fig.24A system.

[0111] Fig.25is an example of a system that includes a flip support catheter having an elongated and flexible body and an expandable funnel, wherein a flexible tube made of a knitted material extends distally along an outer surface of the flip support catheter; a loading sleeve and a tear sleeve extending over the flexible tube and the flip support catheter; and a pair of locking members that are constructed to lock the flip support catheter to a delivery catheter (not shown), and a second flexible tube made of a knitted or braided material that is constructed to be inserted into the flip support catheter.

[0112] Fig.26 Examples of a stop on the proximal end of a rollover support catheter and an elastic cuff on the proximal end of a flexible tube made of a knitted or braided material are shown.

[0113] Fig.27A is an example of a lock configured to lock the flip support catheter to the delivery catheter.

[0114] Fig.27B Attached to both the inversion support catheter and the delivery catheter Fig.27A locking piece.

[0115] Detailed Description

[0116] In general, described herein are flip tube devices (e.g., apparatus and systems) that are particularly suitable for removing larger diameter clots and / or atheromas. Any flip tube device can include a flip support catheter having an elongated and flexible body and an expandable funnel at the distal end of the body, and also includes a flexible tube that flips and flips over the flip support catheter including the expandable funnel when the flexible tube is pulled proximally into the flip support catheter. The flip support catheter can be used with or without the flexible tube.

[0117] like Figure 1A-Figure 1C As shown, the previously described mechanical inversion tube devices (also referred to as "mechanical thrombectomy devices") are configured to effectively remove clots. The devices described herein and methods of using them can be particularly effective for use in peripheral vasculature, including for clots of relatively large outer diameter (e.g., relative to the maximum inner diameter of the inversion support catheter into which the clot is drawn).

[0118] For example, Figure 1A An example of a flip retractor mechanical thrombectomy device 100 is shown (eg, as described in US Patent Application 15 / 496,570 and US Patent Application 15 / 043,996, both of which are incorporated herein by reference in their entirety).

[0119] exist Figure 1B, the flip retractor mechanical thrombectomy device 100 is shown deployed near a clot 109. In the deployed configuration, the retractor 101 (shown here as a retractor microcatheter, optionally the retractor can be a wire) is held within an elongated flip support catheter 107, such that a flexible retractor tube 103 extends from the end of the retractor 101 and expands toward the inner radius of the elongated flip support catheter 107; at the distal opening 111 of the elongated flip support catheter, the retractor tube flips itself and extends proximally in a flip configuration over the distal end of the elongated flip support catheter. Figure 1C As shown, by pulling the retractor proximally, the retractor tube flips 113, 113' over the distal opening of the elongated inverted support catheter and flips over, pulling the adjacent clot into the elongated inverted support catheter as shown.

[0120] Figure 1A The elongated inverted support catheter is an elongated tube having a distal end having the same inner diameter size as the proximal length section of the inverted support catheter. The inverted support catheter 107 is shown located between the retractor tube (e.g., flexible tube 103) and the retractor 101, so that the retractor tube can be pulled proximally by pulling the retractor and flipping the retractor tube into the elongated inverted support catheter to flip it. The portion of the retractor tube that flips over the distal end of the elongated inverted support catheter has an outer diameter that is greater than the outer diameter of the elongated inverted support catheter. The retractor can be biased so that it has a relaxed, expanded configuration with a diameter that is larger than the outer diameter (OD) of the elongated inverted support catheter; further, the retractor tube can also be constructed (e.g., by heat setting, etc.) so that when the retractor tube is inverted and flipped over the distal opening into the elongated inverted support catheter, the outer diameter of the retractor tube within the elongated inverted support catheter has an outer diameter that is approximately y times the inner diameter of the elongated inverted support catheter (e.g., where y is greater than 0.1, 0.5, 0.6, 0.7, 0.75, 0.8, 0.9, 1 times the inner diameter (ID) of the elongated inverted support catheter, etc.). This combination of the retractor tube's un-inverted diameter being larger than the diameter of the elongated inverted support catheter's OD and the retractor tube's inverted diameter being larger than, for example, 0.7 times the ID of the elongated inverted support catheter surprisingly helps prevent device jamming, both when deploying the device and when flipping the retractor over the distal opening of the elongated inverted support catheter to grasp a clot. The tractor can be expandable and can be coupled to the retractor as shown. In some variations, the flexible tractor and the retractor can include the same material, but the tractor can be more flexible and / or expandable, or can be connected to the elongated retractor (e.g., a push / pull wire or catheter).

[0121] exist Figure 1CIn the embodiment of the present invention, the clot can be pulled into the elongated inverted support catheter by pulling the retractor proximally into the distal end of the elongated inverted support catheter, as shown by arrows 113, 113', showing the pulling of the inner portion of the flexible retractor, causing the retractor to flip over the end opening of the catheter and into the distal end of the catheter and flip the expandable distal region, thereby pulling it into the catheter, as shown by the arrows. The end of the retractor outside the catheter may be "loose" relative to the outer wall of the catheter.

[0122] Similar to Figure 1A As shown, Figure 2 An example of a flip tube device 201 is shown. In this example, the flip tube device is located in a large blood vessel having a clot with a diameter greater than 2 times the inner diameter of the flip support catheter. Although the clot can be taken and removed by the flip tube device 201 with a flip support catheter of a narrower diameter, the efficiency of the flip may be low, for example, a flexible tube having a length of about 12 times that of the clot tube is required to capture the entire clot. The figure shows the problem solved by the device described herein; specifically, how to effectively take a long and large diameter clot (e.g., greater than 10 mm) into a relatively small diameter flip tube device. In this example, although a clot of 10 mm or more in diameter can be pulled into a 3 mm diameter (e.g., 8F (French)) flip support catheter of the flip tube device, the efficiency is very low because the length of the flexible tube that must be used to capture the entire length of the clot is very large. Specifically, a 1 cm long clot (which has a diameter of 10 mm) requires a 12 cm flexible tube when flipped and pulled into a 3 mm catheter; therefore, a 5 cm long clot requires a 60 cm flexible tube. The inversion tube device described herein can address and improve this efficiency in a number of ways.

[0123] In particular, the methods and inversion tube devices described herein can dehydrate the clot when the clot is pulled into the inversion tube device. The clot, even including hard or partially calcified clots, may include a large amount of fluid that can be compressed and removed by the inversion tube device described herein. For example, the flexible tube is usually porous and can be, for example, a knitted material. In addition, in some variations, the distal region of the inversion support tube can be constructed, particularly in the distal region (e.g., distal 5mm, distal 4mm, distal 3mm, distal 2mm, distal 1mm, distal 0.9mm, distal 0.8mm, distal 0.75mm, distal 0.7mm, distal 0.6mm, distal 0.5mm, distal 0.4mm, etc.), which can be porous to allow the fluid from the clot to escape the inversion support catheter laterally when the clot is pulled into the elongated inversion support catheter, so that the clot can be more effectively compressed, rather than elongated or stretched. Specifically, the devices and methods described herein include a funnel-shaped distal end on a flip support catheter that can be porous (particularly in an area near the base of the funnel) to allow the clot material to be compressed and the fluid from the clot to be laterally discharged from the side of the flip support catheter when the clot is pulled proximally into the flip support catheter by the flipping of a flexible tube (e.g., a tractor). The funnel can be expandable (also referred to herein as collapsible) and can be integral with or attached to the distal end of the flip support catheter. The funnel can collapse and be guided through a sheath / guide catheter (e.g., an intermediate catheter) so that it can be assembled to a 6F, 8F, 10F, 12F, 14F, 16F, 28F, 20F, and / or 24F sheath in a collapsed state. The expandable funnel can be self-expanding. Alternatively or additionally, the expandable funnel at the distal end of the inverted support catheter can be expanded by actuating the flexible tube; for example, the flexible tube is pulled proximally into the inverted support catheter to flip the flexible tube over the distal end of the inverted support catheter, which can apply a compressive force directed proximally, which pulls and expands the expandable funnel. The maximum outer diameter of the funnel can be greater than 2 times the maximum outer diameter of the collapsed configuration (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, etc.); the maximum outer diameter of the funnel in the collapsed configuration can be approximately equal to or slightly greater than the maximum outer diameter of the main body region of the inverted support catheter (e.g., 1 times, 1.01 times, 1.1 times, 1.2 times, etc., of the outer diameter of the proximal portion of the inverted support catheter). In some variations, the funnel has an outer diameter between 2-26 mm.

[0124] In any of these variations, the flexible tube can also be adapted to better engulf and compress large diameter clots. For example, when outside of an inverted support catheter (e.g., in a blood vessel), the flexible tube in a non-inverted configuration can have an outer diameter selected to be approximately equal to or greater than the maximum outer diameter of the expanded configuration of the funnel.

[0125] The expandable funnel can allow the flexible tube (eg, a braided retractor) to grasp the clot at the edge of the clot's cross-section rather than the center of the clot, which can result in more efficient clot uptake.

[0126] In the flexible tube variations described herein (e.g., the retractor variations), it may be beneficial to heat set the expanded non-inverted outer diameter of the flexible tube (e.g., the portion of the flexible tube on the outside of the inverted support catheter before being pulled into the catheter and inverted) to a diameter (OD) that is larger than the maximum outer diameter of the expanded funnel, and preferably as large as possible relative to the clot OD. A flexible tube with a larger OD may have a higher efficiency in grabbing and squeezing the clot. This may be independent of whether there is a funnel on the distal end of the inverted support catheter. For example, for a flexible tube (e.g., a retractor) formed of a braided material, the OD of the non-inverted flexible tube may be selected to be at least 1 / 3 of the clot OD (or vessel ID), for example, the expanded non-inverted flexible tube may have an OD greater than or equal to about 50%, 60%, 70%, 80%, 90%, 100%, or 110% of the clot OD (or vessel ID).

[0127] As already discussed, the distal end of the invert support catheter, and in particular the expandable funnel on the distal end, can be porous. The ability to allow fluid from the compressed clot to flow out of the side walls of the inner diameter of the funnel (e.g., transverse to the walls of the invert support catheter, rather than just from the distal and proximal ends) can provide a place for fluid removed from the clot to go and can improve the efficiency of the device, allowing a considerable length of clot to be removed with a shorter flexible tube. If the clot is not allowed to escape laterally (e.g., when a non-porous funnel is used), the removed fluid may accumulate at the base of the funnel and may reduce clot removal efficiency. Therefore, in some variations, the funnel is porous or at least partially porous, for example, near the base of the funnel, where the compression ratio of the clot is highest.

[0128] In any of the variations described herein, the everted support catheter can be relatively large so that the clot does not have to be compressed as much. For example, in the peripheral vasculature, the everted 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, 5 mm, etc.

[0129] In general, any of the devices described herein can also improve the efficiency of the device for removing clots by reducing the force required to remove the clot. For example, the methods and devices described herein can include a lubricating material on the distal end (e.g., funnel) of the inversion support catheter. For example, in any of these devices, the funnel can be lined with a smooth material (e.g., a PTFE liner (polytetrafluoroethylene liner)), which may cause a lower intake pull force and / or may reduce the intake efficiency. The smooth funnel may allow the clot mass to be dragged into the mouth of the funnel instead of pulling it into the catheter.

[0130] In some variations, the funnel can be configured to have a specific shape (e.g., a cone), which can also help improve the efficiency of compression and / or dehydration of the clot, and can help reduce the size of the required force. For example, in some variations, a longer funnel can have a lower uptake force and better clot uptake efficiency than a shorter funnel with the same maximum OD / minimum ID. The example of the funnel can have a maximum OD of, for example, 3mm, 5mm, 6mm, 8mm, 10mm, 12mm, 15mm, 20mm, 25mm, etc. Exemplary funnel lengths can be, for example, 5cm, 10cm, 15cm, 20cm, 25cm, 30cm, 40cm, 50cm, 50cm, 100cm, etc. The main body of the elongated flexible inverted catheter can be, for example, a 3F, 4F, 5F, 6F, 7F, 8F, 9F, 10F, 11F, 12F, 14F, 16F, 18F, 20F, 25F catheter, etc.

[0131] For variations where the flexible tube includes a braided material, coarser waves may have enhanced efficiency. For example, a greater number of braided "fingers" (e.g., coils) in the transverse direction of the tube may have a higher clot uptake efficiency (per circumference of the braid). For example, the number of gripping fingers per circumference of the tubular braid may be at least 10, 20, 20, 40, 50, 60, 100, etc.

[0132] Typically, both before actuation and during operation, the inversion tube device described herein can be highly flexible. For example, a flexible tube (e.g., a tractor) may not significantly increase the stiffness / flexibility of the catheter of the elongated inversion support, especially the distal region of the catheter, to avoid affecting operability. Described herein is a flexible tractor tube portion that increases the stiffness of the last y cm of the catheter (e.g., the most distal 20cm, 18cm, 15cm, 12cm, 10cm, 9cm, 8cm, 7cm, 6cm, 5cm, 4cm, 3cm, 2cm, 1cm, etc.) by less than a predetermined percentage (e.g., less than 10%, 12%, 15%, 18%, 20%, 25%, 30%, etc.). For example, described herein is a flexible tractor tube portion that passes through the catheter and folds back over the distal end of the catheter, but increases the stiffness of the distal 5cm of the catheter by less than 15% of the stiffness of the distal 5cm of the catheter (the flexible tube does not extend through the catheter and folds back over the distal end of the catheter).

[0133] The flexible tube (e.g., a retractor) can be of a braided, woven, and / or knitted material. For braided and woven materials, which can include multiple fibers that are woven or woven to form a flip tube, these structures can be adjusted to prevent jamming and / or reduce the force required to pull the retractor and flip over the catheter tip. For example, a mechanical atherectomy device can include a knitted or woven flexible tube that can flip freely around the tip of the catheter even in curved anatomical structures and when a clot is grasped by adjusting one or more braiding structures; minimize the braiding angle; include a hydrophilic coating on the distal portion of the outer diameter (OD) of the catheter or the inner diameter (ID) of the braid (e.g., a retractor); include a curved wall on the catheter; and / or increase the stiffness of the distal tip region relative to the adjacent side region. Optionally, it may be advantageous to have a hydrophilic coating at 1, 3, 5, 10, or 15 cm of the distal ID or the entire catheter ID.

[0134] As described above, the flexible tube (e.g., a retractor) can be braided, woven, knitted, etc., and can be constructed to collapse as little as possible to enter the inner diameter (ID) of the catheter. For example, the retractor can collapse to an ID greater than, equal to, or within 90%, 85%, 75%, 70%, 65%, 60%, or 50% of the inner diameter (ID) of the catheter / catheter tip OD, because at this ID based on the elongated body region of the flip-support catheter, when the retractor is pulled around the catheter tip, it can create axial tension on the retractor (e.g., braid, knit, etc.), which may otherwise inadvertently and undesirably cause the retractor to get stuck on the catheter tip. When the retractor is pulled around the catheter tip, the retractor can be pulled in an axial direction, creating axial tension on the retractor structure when the retractor is pulled through the catheter ID. By having the retractor element stuck at an ID greater than or equal to 90%, 85%, 75%, 70%, 65%, 60%, or 50% of the catheter ID (or in some variations, OD), the retractor is less likely to catch / snap onto the catheter tip when axially tensioned to help the braid flip around the catheter tip by the smaller axial force applied by the user. If the user requires less axial force to pull the retractor structure around the tip, the catheter tip is less likely to bend or deflect when the retractor is retracted. Minimizing the likelihood of bending the catheter tip may be advantageous. The retractor can be adjusted to "stuck" at a specific inner diameter by controlling any and any combination of the following variables: selecting a specific number of braid ends, selecting the size / diameter of the braid ends; selecting a braid material (e.g., multifilament or monofilament); heat setting the deviation on the braid (e.g., braid diameter); and selecting a braid pattern, such as 1×2, 1×1, or any other pattern.

[0135] The braid angle can be minimized to prevent the locking retractor from flipping over the catheter end opening. Generally, the smaller the 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.), the less likely it is that the braid intersection will get stuck on the catheter tip.

[0136] In any of the variations described herein, the surfaces of the catheter and / or retractor may be coated to enhance flapping over the distal region of the catheter. It may be helpful to have a hydrophilic coating on the distal portion of the catheter OD or retractor ID so that the retractor can more easily slide over the distal end of the catheter and around the catheter tip as the retractor is pulled through the interior of the catheter.

[0137] The stiffness of the distal end of the elongated inverted support catheter can be hard enough to prevent collapse when the retractor is pulled; it can also be smooth (e.g., by coating or material properties). The distal-most portion of the tip of the elongated inverted support catheter (e.g., the last 5 mm) can be made of a material that is hard enough and smooth enough so that when the braided structure is flipped around the catheter tip, the distal tip of the catheter does not collapse or bend inward. Therefore, the distal tip can have greater stiffness than the more proximal region at the distal end of the catheter.

[0138] Figure 3A-3B and Figure 4A-4B Examples of inversion tube devices are shown, each of which includes a funnel region at the distal end of an inversion support catheter. Figure 3A A first variation of an inversion tube device 300 is shown, which includes an elongated flexible inversion support catheter 307 having an expandable funnel 308 at the distal end. Figure 3A 309 and after being released from the intermediate catheter. Figure 3B The funnel can be formed of a woven material and can be porous, particularly at the base region 313, where the funnel extends from the body of the elongated body of the inversion support catheter. The flexible tube 305 extends over the distal end of the inversion support catheter (including the funnel) and is inverted over the distal opening of the funnel. The flexible tube can be, for example, a knitted material and can be biased to expand to an outer diameter (OD) that is larger than the OD of the funnel 308 in the expanded configuration. The flexible tube is attached to the distal region of the retractor 303. At Figure 3A-3B In the example shown, the retractor extends distally 315, extending further than the distal end of the funnel, as shown. Although a flexible tube (e.g., a retractor) is attached to the distal region of the retractor, in this example, the end of the flexible tube is attached near the distal end of the device.

[0139] exist Figure 4A-4B In the example of the eversion tube device 400 shown, the flexible tube 405 is attached at a distal region of the retractor 403 closer to or at the distal end of the retractor. Figure 3A An inversion tube device 400 is shown within an intermediate catheter (e.g., a delivery catheter) 409 with a funnel 408 at the distal end of an inversion support catheter 407 in a collapsed configuration within the intermediate catheter. The funnel may include one or more (e.g., multiple circumferentially arranged) openings or holes at a base 413 region to allow fluid from the clot to exit the inversion support catheter when the clot is pulled into the inversion support catheter (e.g., a retractor region) due to the inverted flexible tube 405. Figure 4B The device is shown at least partially deployed outside of the intermediate conduit 409 with the expandable funnel 408 expanded.

[0140] Figure 4C is a picture of a prototype device 400' in which an inverted support catheter 407' includes an expandable funnel 408' (shown expanded) and a flexible tube 405' can be flipped and inverted over the funnel 408' to capture clotted material when used as a thrombectomy device. Figure 4C In the embodiment of the present invention, the flexible tube is shown as a knitted tube, forming a plurality (e.g., >15) of coils or fingers at the distal-facing end of the device, which can help capture clotted material. Figure 5A and Figure 5B is shown in more detail in .

[0141] exist Figure 5A and Figure 5B , a porous funnel 508 is shown forming the distal end of an inverted support catheter 507, and the knitted flexible tube 505 is shown inverted over and into the funnel as the flexible tube is pulled proximally into the funnel.

[0142] In some variations, the expandable funnel may be formed from a woven and / or braided material, such as Figure 6A-6D For example, in Fig. 6A In the apparatus, the funnel is constructed to withstand relatively large compressive loads, which may be necessary to compress and / or dehydrate a large diameter clot as it is drawn into the apparatus. Fig. 6A In FIG. 6 , funnel 608 is shown collapsed; the funnel may be collapsed to a smaller OD to enable guidance through a small ID sheath, such as by elongating the funnel shape, as shown. Figure 6B As shown, the funnel can self-expand to a fully or partially expanded configuration, for example, when released from a delivery catheter within a blood vessel. Figure 6C As shown, when the clot is pressed into or against the body 609, the funnel may expand further (more fully), causing a compressive force 611 to be applied in the proximal direction on the funnel, jamming it into a higher strength configuration, as will be described below. Fig.12 As shown in more detail in . Fig.6D Shown is a distal perspective view of the funnel end of the inverted support catheter with a knitted retractor (knitted flexible tube) 603 inverted into the funnel. In this example, the funnel flares outward from 5 mm ID to 8 mm ID in the expanded configuration.

[0143] Fig. 7A and Figure 7B An example of an inversion tube device is shown having a flexible tube (eg, a knitted retractor tube 703 ) and an inversion support tube 705 that includes an expandable funnel 708 that ingests a clot 711 . Fig. 7A The clot and device before ingestion are shown. Figure 7BThe clot is shown located within the flexible tube after it has been removed from within the inversion support tube, after ingestion into the inversion support catheter (the braided flexible tube is shown attached to the retractor 709). Figure 8A-8B Another example of an inversion tube device 800 is shown, showing that a non-funnel tip inversion support catheter 807 has been heat set so that the braided flexible tube (retractor tube) has an outer diameter approximately equal to the OD of the clot 811, resulting in relatively high clot removal efficiency, as shown in FIG. Figure 8B , the captured clot 811 ' is shown after being removed from the device.

[0144] like Figure 9A-9C As shown, generally, clot removal efficiency can be increased by the size of the outer diameter of the flexible tube. Fig.9A An example of an eversion tube device (thrombectomy device) 900 is shown, which includes an eversion support catheter 907 and a braided flexible tube 905. Fig. 9B is a graph showing the length (in cm) of the knitted flexible tube (retractor tube) required by the device in order to completely capture a 5 cm long clot having an outer diameter of 15 mm. As shown, in the non-inverted, expanded configuration, such as on the outside of an inverted support catheter, the larger the outer diameter of the flexible tube, the smaller the length of the braided flexible tube required. Fig. 9C Examples of various inverted tube devices are shown, with exemplary dimensions shown.

[0145] Any suitable expandable funnel-shaped distal end may be used. For example, Figure 10A-10C Different variations of the funnel-shaped distal end are shown. Figure 3A In FIG, a funnel 1013 is shown, and may be rigid, or may include openings that allow fluid to pass therethrough (e.g., may be porous), including being porous across its entire surface. Fig. 10B In the example shown, only a portion of the expandable funnel is porous. Fig. 10B , the base region 1023 is porous and includes a plurality of openings arranged circumferentially around the periphery of the base region of the funnel 1013 .

[0146] Fig. 10C The illustrated variation of expandable funnel 1013 is porous throughout its length and is shown as being formed from a braided material (eg, metal or polymer fibers) that can be folded back upon itself to form the funnel shape. Fig. 10D Shown by Fig. 10C1007, and a second end 1025 of a portion of the funnel within the mouth of the funnel. Any of these variations may include a lubricious sleeve (e.g., a Teflon sleeve).

[0147] Figures 11A-11D An example of a distal end of an inversion support catheter including a funnel is shown. In this example, the funnel is integrally formed with the body of the inversion support catheter. Fig.11A As shown in the schematic diagram in FIG. 1 , the funnel shape includes a frame formed by a plurality of fingers or struts 1111 formed by cutting (e.g., laser cutting) the distal end of the body of the inverted support catheter 1107. Fig.11A , a braided or woven funnel body 1118 is attached to a strut; the braided body is attached 1105 on one end to the body of the inversion support catheter and is locked in place on the strut at the other end 1109. Fig. 11B An example of a body of an elongated support conduit that has been cut into a plurality of struts or fingers on which the funnel body may be supported is shown. Fig. 11C The distal end of the funnel 1131 is open and can extend beyond the struts and can snap to form a locked open configuration with high compressive strength (even in the absence of underlying struts or fingers). Fig.11D An example of the open distal end of the funnel of the device is shown.

[0148] Fig.12 yes Fig. 11C A magnified view of the distal end of the funnel is shown illustrating the application of axial compression which may cause the distal end of the device to "jam" and form a greater braid angle at the distal end compared to the more proximal end which is not jammed. This compressive force can help open (and keep open) the expandable funnel.

[0149] Figures 13A-13D Another variation of the funnel portion of the inversion support catheter is shown, including a lubricated sleeve (e.g., a Teflon sleeve). Fig.13A , a schematic diagram of the funnel shows that it can be formed by a plurality of arms 1303, and a braided funnel body 1305 can be bonded to the arms formed by the body of an inverted support conduit 1307 (similar to Figures 11A-11D ). The braided body can be bonded to the catheter body 1316. In addition, as shown, a Teflon sleeve 1309 can be attached at one or more locations along the outer diameter of the braided body region. Fig.13AIn the embodiment, the Teflon sleeve does not cover the base area, allowing the fluid to flow laterally out of the funnel near the base of the funnel.

[0150] Fig. 13B yes Fig.13A Side view of a prototype of a flip-stent catheter, shown in a side perspective view in a collapsed (non-expanded) configuration. Fig. 13C The funnel is shown in an expanded configuration. A Teflon sleeve 1309 is shown partially along the length of the funnel, attached on the outside of the expanded funnel. Fig.13D Shows Figure 13B-Figure 13C End view of the distal end of the funnel of the flip support catheter.

[0151] Figure 14A-Figure 14C Various examples of lubricating sleeves are shown, which may be included in any of the devices shown. Fig.14A In the invention, a Teflon sleeve (PTFE tube) is attached inside the mouth of the funnel and may be attached at the distal end but allowed to float at the proximal end. Fig. 14B In the , a lubricated sleeve (PTFE sleeve) is attached below the braided body that forms the funnel shape and can be bonded at the proximal end or allowed to float. Fig. 14C In the , a lubricating sleeve is attached on the outside and flipped over the distal end of the funnel shape and allowed to float proximally (or can be attached proximally).

[0152] Fig.15A and Fig. 15B Other variations of inverted support catheters including funnels are shown. Fig.15A In the funnel, a set of laser cut fingers are formed and form the funnel; as described above, the funnel body material can be attached to the inside of the funnel shape and / or to these shapes. Fig. 15B In the embodiment, the end of the catheter body can be laser cut into a plurality of curved arms that can form a funnel shape.

[0153] As described above, a variety of different configurations and sizes may be used, and the user may select between configurations and sizes based on the size of the blood vessel in which the device is to be used. Figures 16A-16D Four variations of inverted tube devices that can be used are shown. Fig.16A , a 5F device is shown that does not include a funnel on the distal end of the inversion support catheter. Fig. 16B The example shown (sized for a 6F system) includes an inverted support catheter with an expandable funnel. Fig. 16C and Fig.16D 8F and 10F devices are shown respectively.

[0154] Figure 17A-17CVariations are shown in which the flexible tube is configured to have an expanded (eg, non-compressed) configuration that is narrow ( Fig.17A ), such as being smaller than the maximum OD of the dilated funnel, or being wide ( Fig. 17B and Fig. 17C ), for example, greater than the maximum OD of the expansion funnel. Fig. 17C In the embodiment, the delivery catheter 1705 can be used to drive the flexible tube distally (e.g., to prevent tension) when the flexible tube is flipped over a funnel at the distal end of the flip support catheter by pulling the first end of the flexible tube proximally within the flip support catheter.

[0155] Also described herein is a flip tube device configured for atherectomy. In some variations, the flip tube device includes a flexible tube and a flip support catheter (e.g., with an expandable funnel at the distal end), and may also include one or more annular cutters for cutting into and / or around atherosclerotic plaques within a blood vessel. For example, Fig.18A An example of a flip tube device including a pair of annular cutters (e.g., MollRing cutters) is shown, which can be used to cut atheromatous plaques laterally. The annular cutter can pass through the outside of the flip support catheter. In some variations, the flipping, flipping flexible tube can be formed by sharp or cutting materials, such as laser cutting material sheets (e.g., metals, polymers, etc.) to cut at an angle relative to the vertical line, thereby having a sharp edge that can engage and cut calcified materials and / or tissues. The cutting ring can further allow cutting into and through dense plaque materials.

[0156] Any of the inverted support catheters described herein (including an expandable / collapsible funnel at its distal end) can be configured to collapse to a small diameter to facilitate easy insertion of a catheter and / or sheath, including when a flexible tube (e.g., a retractor) is preloaded around the funnel. In use, a tool, such as an introducer sheath, can be used to keep the distal end (e.g., funnel) of the inverted support catheter, with or without a flexible tube attached, in a collapsed form so that it can be easily inserted into the cavity of a delivery catheter, which may already be positioned in the body, or can be loaded into the body with the inverted support catheter and flexible tube assembly inserted. Collapsing the funnel at the distal end into a smaller diameter can help the "loaded" inverted support catheter pass through the delivery catheter and thus enter the body. If a tool such as an introducer sheath is used, it can be removed during or after loading; the introducer sheath can be a polymer (e.g., plastic) tapered tube having a slit, perforation, or tear region extending along the length. The funnel can be collapsed and inserted into the wider end of the introducer sheath, and the inversion support catheter can be pushed to slide distally within the introducer sheath toward the narrower end. The narrow end can then be loaded into the delivery catheter, and the inversion support catheter can be pushed distally out of the introducer sheath and into the delivery catheter; the introducer sheath can then be torn along its length (e.g., along a preformed tear line) to remove it from around the inversion support catheter. Fig.25 One example of an introducer sheath is shown and described in more detail below.

[0157] The funnel portion of the inverted support catheter can be configured to collapse to a diameter smaller than the rest of the inverted support catheter, such as the diameter of the region near the funnel, at least in the distal region. For example, the funnel can be configured to collapse to fit over a sheath or guide catheter (also referred to herein as a delivery catheter) of 3F, 4F, 5F, 6F, 7F, 8F, 9F, 10F, 12F, 14F, 16F, 18F, 20F, 24F, 30F, etc.

[0158] The funnel portion of the flip support conduit can be suitable for this purpose in many ways, including but not limited to the features of the parts forming the funnel portion. For example, in some variations, the outer surface and inner surface of the funnel portion can be formed by a mesh material, such as a braid. A specific mesh or braided structure can contribute to the amount that the funnel can collapse, such as the number of filaments (e.g., the number of ends) forming the braid, the size of the filaments (e.g., the size of the ends), the braiding angle, etc. In some variations, the funnel includes a plurality of longitudinal tines between the inner surface and the outer surface formed by a mesh or other material, and the ability of the funnel portion to collapse can be determined in part by the ability of the tines to move in the inner and outer surfaces (e.g., the mesh or braided material forming the wall of the funnel). For example, the braided tube forming the wall of the funnel can slide relative to the tines to allow the funnel to collapse to a small diameter for introduction.

[0159] Fig.19 A portion of one example of an inverted support catheter having a funnel at the distal end is shown. The funnel can be formed in part by a plurality of tines 1905 extending from the distal end of the inverted support catheter. For example, the distal region of the inverted support catheter can be formed from a metal hypotube that is cut, such as by laser transverse cutting, to form the tines. Fig.19 In FIG. 6 , six tines are shown. The tines may be flared outwardly from each other (e.g., on a mandrel) (e.g., Fig. 20A In some variations, the tines may be formed by folding the cutting "arm" back upon itself so that the distal end 1909 is blunt or rounded, as shown. Fig.19 In this example, the folded portions of the tines 1907 can be folded inwardly and crimped together as shown. In some variations, a filament can be included to radially connect the individual tines in the plurality of tines. This Fig. 20A and Fig. 20B . In this example, filament 2007 is a suture threaded through the distal end of the tines 2005 (where they fold back on themselves). Typically, the filament is attached at or near the distal end of the tines (e.g., within 1mm, 2mm, 3mm, 4mm, etc. from the distal end). Each tine 2005 shown is connected to a radially adjacent tine by a filament 2007. Connecting the tines to each other along their length (including at their distal ends) can help disperse forces that might otherwise cause the tines to collapse and / or bend, impairing the function of the inversion support catheter.

[0160] Fig.21A and Fig.21B An example of a mesh material that can be used to form the outer and inner surfaces (e.g., walls) of the funnel is shown. A tube 2100 of mesh (e.g., woven) material is provided in Fig.21A 2104. In the embodiment of the present invention, the inner layer 2103 and the outer layer 2104 are shown in the figure, which have been turned over by themselves as shown in the figure, forming an inner surface 2103 and an outer surface 2104. In order to form a funnel, the tines can be inserted between these inner and outer surfaces, and the outer end can be attached to the outside of the proximal region of the flip support catheter. The material (e.g., braid) forming the wall can be shaped (e.g., heat-set) into the double layer. Specifically, the material can be shaped so that in the jamming configuration, the inner layer has an outer diameter (OD) that is smaller than the inner diameter (ID) of the outer layer, which can create space for the tines to slide.

[0161] Fig.21B Shows Fig.21A An enlarged view of a portion of the braided wall material. Fig.21BIn the embodiment, the braided material is shown as a braid of flat wires; wires of round and / or flat cross-sections can be used to form the braided material. As described above, the braid angle can be selected to allow compression of the funnel and to set a jammed configuration in which the funnel is maximally expanded.

[0162] Figure 22A-22C A funnel 2200 is shown, which is formed by Fig.21A The braided wall material shown is applied to the tines at the distal end of the inversion support catheter (eg Fig.19 In the example shown in FIG. Fig.22A In the embodiment of the present invention, the inner and outer walls of the braided material forming the funnel are sutured together by sutures 2221, which are arranged radially around the funnel and can limit its 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 can extend distally further than the distal ends of the tines. Fig.22A In the relaxed configuration shown, the length of the braid distal to the distal ends of the tines 2214 is shown as a distance X1 centimeter. Fig. 22B Shown is a funnel with a stuck braid 2213, just as a tractor (e.g., flexible tube) is loaded onto the funnel and pulled proximally into the inversion support catheter. In this configuration, the axial length of the braided wall extending beyond the tip of the tines is X2 cm. Fig. 22C The braided wall is shown collapsed (and loaded into introducer sheath 2217) so that the axial length of the braided wall extending beyond the tips of the tines is X3 centimeters.

[0163] In some variations, it may be beneficial to limit the axial length of the braided wall extending beyond the tips of the tines in the fully expanded (e.g., jammed) configuration. This may prevent instabilities, particularly lateral instabilities. For example, it may be beneficial to limit the axial length of the braided wall extending beyond the tips of the tines in the fully expanded (e.g., jammed) 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, such as between 1 mm and 10 mm, between 1 mm and 8 mm, between 1 mm and 7 mm, between 1 mm and 6 mm, between 1 mm and 5 mm, between 1 mm and 4 mm, etc.). In particular, limiting it to 5 mm or less may be beneficial.

[0164] Fig.23Another example of an inverted catheter including a funnel as described above is shown. In this example, the funnel 2300 includes a suture 2413 (e.g., a restraining filament) integrated between the inner and outer layers (e.g., inner and outer walls) of the funnel to prevent relative sliding of the inner and outer braided layers, so that the braid is stuck at the tip while allowing the tines 2318 to slide between the inner and outer braided material walls. As shown, the suture limits the diameter 2305, 2307 of the funnel in the expanded configuration.

[0165] In some variations, the outer diameter of the funnel at different positions along the length of the funnel can be limited or set by using a constraining filament (e.g., suture, silk thread, etc.). The constraining filament (one or more than one) may be referred to herein as a circumferential support member that extends radially around the funnel surface and constrains the maximum outer diameter of the expandable funnel. The constraining filament can be maintained in place by suturing it to a mesh (e.g., braided) material that forms a funnel wall (one wall or more than one wall). Therefore, the filament can limit the OD of the funnel to a desired diameter / profile.

[0166] As described above, each of these funnels includes a porous structure that allows the clot or tissue to be partially dried when it is pulled in through the base of the funnel by allowing the fluid to seep out through the sides of the funnel. The funnel described herein can smoothly transition from the funnel ID to the catheter ID. This can be achieved by laser cutting the tines at the distal end of the catheter, as shown. In these examples, the porous structure and / or smooth transition can also be provided by a porous metal mesh (e.g., braided) structure that forms the wall.

[0167] The flip support catheter described and shown herein can be adapted to prevent collapse, even in the absence of clot material or in the presence of a force applied by the flexible tube. In any of these variations, the funnel needs to be able to withstand an axial load (e.g., a load applied along the axis of the axial length of the catheter) that may exceed 1, 2, 3, 4, 5, 10, 15 and / or 20 kg without collapsing, for example, when there is resistance to ingesting clots, while still allowing the flexible tube (e.g., a tractor) to flip around the top of the funnel and enter the flip support catheter. Axial stiffness can be achieved at least in part by configuring the braided wall of the funnel to have a jamming configuration at the top as described above. Axial stiffness can also be improved by limiting the length of the braided wall extending beyond the distal tip of the tines in the jamming configuration (e.g., limited 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 load applied to the funnel tip from the retractor so that the funnel tip remains rounded and no one finger becomes isolated and collapsed.

[0168] In general, these same factors can also improve radial stiffness. The end of the funnel can also preferably be hard enough to prevent the funnel from radially collapsing when the tractor is flipped around the tip. The radial stiffness of the funnel can be achieved at least in part by configuring the braided wall of the funnel to have a jamming configuration at the top as described above. The radial stiffness can also be improved by limiting the length of the braided wall extending beyond the distal end of the tines in the jamming configuration (e.g., limited to 5 mm or less). In some configurations, the radial stiffness can also be improved by including a circumferential support (e.g., a filament) between the tines, which, as described above, can disperse the load applied to the tip of the funnel from the tractor so that the tip of the funnel remains round and no finger is isolated and collapsed.

[0169] In any of the funnels described herein, the funnel can be configured to fully expand only when an axial load is applied, such as when a flexible tube (e.g., a retractor) is pulled proximally to flip into the flip support catheter. This can allow the funnel to be advanced in smaller vessels before being actuated.

[0170] For example, Fig.24A An example of an assembly is shown that includes an inverted support catheter having a funnel as described above, wherein a flexible tube is loaded onto and into the inverted support catheter such that the flexible tube (retractor) extends along the outside of the inverted support catheter and over the funnel before being inverted into the interior of the funnel as shown. Fig.24A In FIG. 2 , the funnel 2405 is not fully expanded and the braided flexible tube 2403 is not pulled into the inversion support catheter. Fig. 24B In the embodiment of the present invention, the flexible tube 2403 is pulled into the inversion support catheter, causing it to flip into the catheter; in doing so, the flexible tube / retractor applies an axial load and fully extends the funnel 2405 to the stuck configuration. Fig.24A The portion of the funnel wall extending beyond the tines 2407 in the relaxed configuration shown is greater than the portion of the funnel wall extending beyond the tines 2407 in the relaxed configuration shown. Fig. 24B The jammed configuration shown extends beyond the length of the tines 2409.

[0171] As described above, any of the devices described herein can be packaged or otherwise included together to form a kit, for example, for use in removing thrombi. Fig.25 A diagram of a system packaged together for performing a thrombectomy procedure is shown. Fig.25In the system 2500, the system 2500 includes pre-loaded components, such as a flip support catheter 2512 that has been pre-loaded with a retractor (flexible tube); the assembly of the flexible tube and the flip support catheter is shown as being encapsulated in a loading sheath 2503 (a spare loading sheath 2522 is also shown) for loading into a delivery catheter (not shown). The assembly of the flexible tube and the flip support catheter is also covered proximally in a tear sleeve 2511, which extends over the flexible tube and the flip support catheter and is constructed to be removed from the flexible tube by tearing along the length of the tear sleeve when the flip support catheter and the flexible tube are loaded into the delivery catheter. A pair of locking members 2514 are also provided. Fig.25 Shown as part of the suite. Fig.25 In the embodiment of the present invention, a pair of additional retractors 2520 (flexible tubes) connected to the retractor are also included. These additional flexible tubes can be loaded into the flip support catheter after completely removing the pre-loaded retractors.

[0172] For example, after the original inverted support catheter has been pulled through the lumen of the inverted support catheter, such as when removing a clot, an additional flexible tube can be loaded onto the inverted support catheter. In some variations, the additional flexible tube can be attached to a retractor, and the retractor and a portion of the additional flexible tube (e.g., a first portion) can be pulled through the distal end (funnel end) of the inverted support catheter, while the second portion can be pulled over the exterior of the inverted support catheter.

[0173] like Fig.26 As shown, any of the inversion support catheters 2601 described herein may include a stopper 2607. For example, as described above, when the assembly of the flexible tube and the inversion support catheter is loaded into the delivery catheter, and / or when the flexible tube is loaded onto the inversion support catheter, the stopper can prevent the proximal end of the retractor (flexible tube) 2603 from being pushed proximally past the stopper. For example, the stopper can engage with a cuff (e.g., an elastic cuff) 2609 on the end of the retractor. The tear sleeve also helps to reduce or prevent this situation.

[0174] Fig.27A and Fig.27B An example of a locking member 2701 is shown that can be used to secure the inversion support catheter 2711 to the delivery catheter 2713 so that the two parts can move together. Fig.27A As shown, the locking member may include an annular clamp 2703 for connecting to the outside of the inversion support catheter, and an L-shaped or J-shaped locking member 2705 for coupling to the end of the delivery catheter. By loosening or tightening the annular clamp, the inversion support catheter may be allowed to slide alone or coupled with the delivery catheter.

[0175] Any method described herein (including user interface) 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 that can be executed by a processor (e.g., a computer, tablet, smartphone, etc.), which, when executed by the processor, causes the processor to control any of the steps in the execution process, including but not limited to: display, communication with the user, analysis, modification of parameters (including timing, frequency, intensity, etc.), confirmation, alarm, etc.

[0176] When a feature or element is described as "on another feature or element" in this article, it can be directly on other features or elements, or there may also be intermediate features or elements. On the contrary, when a feature or element is described as "directly on another feature or element", there is no intermediate feature or element. It should be understood that when a feature or element is described as "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to other features or elements, or there may be intermediate features or elements. On the contrary, when a feature or element is referred to as "directly connected", "directly attached" or "directly coupled" to another feature or element, there is no intermediate feature or element. Although described or shown with respect to one embodiment, the features and elements described or shown in this way can be applied to other embodiments. It should be understood by those skilled in the art that the structure or feature mentioned as "adjacent" another feature setting may have a portion overlapping with an adjacent feature or below an adjacent feature.

[0177] The terms used herein are only used for the purpose of describing specific embodiments and are not intended to limit the present invention. For example, unless the context clearly indicates otherwise, as used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well. It should be further understood that the terms "comprises" and / or "comprising" when used in this specification specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, 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 related listed items and may be abbreviated as " / ".

[0178] Spatially related terms, such as "under", "below", "lower", "over", "upper", etc., may be used herein to facilitate description of the relationship of one element or feature to another one or more elements or features as shown in the accompanying drawings. It will be understood that spatially related terms are intended to include different orientations of the device in use or operation other than the orientation depicted in the accompanying drawings. For example, if the device in the accompanying drawings is reversed, such as an element is described as "under" or "beneath" other elements or features, the element will be oriented "over" other elements or features. Thus, the exemplary term "under" may cover both orientations of "over" and "under". The device may be otherwise oriented (rotated 90 degrees or in other orientations), and the spatially related descriptors used herein are interpreted accordingly. Similarly, unless otherwise specifically stated, the terms "upwardly", "downwardly", "vertical", "horizontal", etc. are used herein for illustrative purposes only.

[0179] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Therefore, without departing from the teachings of the present invention, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element.

[0180] Throughout this specification and the appended claims, unless the context requires otherwise, the term "comprise" and variations thereof such as "comprises" and "comprising" mean that various components (e.g., compositions and apparatus including devices and methods) can be used together in methods and articles. For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0181] In general, any of the devices and methods described herein should be understood to be inclusive, but all or a subset of components and / or steps may optionally be exclusive and may be expressed as "consisting of" or optionally "consisting essentially of" the various components, steps, sub-components or sub-steps.

[0182] As used herein in the specification and claims, including in the examples, and unless otherwise expressly stated, all numbers may be read as if beginning with the word "about" or "approximately", even if the term does not appear explicitly. The phrase "about" or "approximately" may be used when describing amplitude and / or position to indicate that the value and / or position described are within the reasonable expected range of the value and / or position. 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. Any numerical value given herein should also be understood to include about or approximately that value, unless the context otherwise indicates. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical range listed herein is intended to include all subranges contained therein. It should also be understood that when a value is disclosed, "less than or equal to" the value, "greater than or equal to the value," and possible ranges between values ​​are also disclosed, as appropriately understood by those skilled in the art. For example, if the value "x" is disclosed, then "less than or equal to x" and "greater than or equal to x" (e.g., where x is a numerical value) are also disclosed. It should also be understood that throughout the application, data is provided in a variety of different formats, and that the 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, it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15, and between 10 and 15 are considered disclosed. It should also be understood that each unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0183] Although various illustrative embodiments are described above, any of several changes may be made to the various embodiments without departing from the scope of the invention as described in the claims. For example, in alternative embodiments, the order in which the various described method steps are performed may generally be changed, and in other alternative embodiments, one or more method steps may be skipped together. Optional features of the various device and system embodiments may be included in some embodiments and not included in other embodiments. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0184] The examples and descriptions included herein show specific embodiments in which the subject matter can be practiced by way of illustration and not limitation. As mentioned, other embodiments can be utilized and derived therefrom so that structural and logical replacements and changes can be made without departing from the scope of the present disclosure. For convenience only, such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term "invention", and it is not intended that the scope of the present application is actively limited to any single invention or inventive concept, if in fact more than one is disclosed. Therefore, although specific embodiments have been illustrated and described herein, any arrangement that is considered to achieve the same purpose may replace the specific embodiments shown. The present disclosure is intended to cover any and all modifications or variations of various embodiments. After reading the above description, those skilled in the art will understand the combination of the above embodiments and other embodiments not specifically described herein.

[0185] This article also provides the following items:

[0186] 1. A thrombectomy system, comprising:

[0187] an inversion support catheter having an elongated and 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 that communicates with an interior of the funnel and, in turn, with the catheter lumen; and

[0188] a flexible tube that is flipped over the distal end of the funnel so that the flexible tube has a first region that is at least partially disposed within the interior of the funnel and a second region that extends at least partially over the exterior of the funnel, wherein the flexible tube is configured to be pulled proximally into the catheter lumen by pulling the first region proximally so that the second region flips over the distal end of the funnel when the flexible tube is pulled into the catheter lumen.

[0189] 2. A system according to item 1, wherein a portion of the second region of the flexible tube extends at least partially above the outer surface of the catheter body proximal to the funnel, and wherein the inner diameter of the portion of the second region extending above the outer surface of the catheter body is smaller than the maximum outer diameter of the funnel when the funnel is in an expanded configuration.

[0190] 3. A system according to item 1 or 2, wherein a base region of the funnel adjacent to the distal end of the catheter body includes an opening configured to allow fluid to pass therethrough.

[0191] 4. A system according to item 1 or 2, wherein the funnel includes a circumferential porous area at the base of the funnel adjacent to the distal end of the catheter body, the porous area being configured to allow fluid to pass therethrough.

[0192] 5. A system according to any one of items 1-4, wherein the funnel has a collapsed configuration, and the collapsed configuration has a maximum outer diameter that is less than 0.3 times the outer diameter of the catheter body proximal to the funnel.

[0193] 6. A system according to any one of items 1-5, wherein the funnel has an expanded configuration in which the funnel has a minimum outer diameter that is greater than 2 times the outer diameter of the catheter body proximal to the funnel.

[0194] 7. A system according to item 6, wherein the funnel has an outer diameter of between 2 mm and 26 mm in the expanded configuration.

[0195] 8. A system according to any one of items 1-7, wherein the flexible tube comprises a knitted tube.

[0196] 9. A system according to item 8, wherein the knitted tube has more than 10 loops for each cross-section through the knitted tube along the length of the knitted tube.

[0197] 10. A system according to any one of items 1-9, wherein the funnel is constructed to assume a jammed configuration when the first region of the flexible tube is pulled proximally and an axial compressive force is applied to the distal end of the funnel.

[0198] 11. The system of item 10, wherein the funnel has a greater column strength in the stuck configuration than when the funnel is not in the stuck configuration.

[0199] 12. The system of item 10, wherein in the jammed configuration, the funnel is constructed to withstand a compressive force greater than 1200 g without collapsing.

[0200] 13. A system according to any one of items 1-12, wherein the funnel includes a plurality of longitudinal tines that are continuous with the catheter body proximal to the funnel.

[0201] 14. A system according to item 13, wherein the funnel also includes a mesh, which flips over itself at the distal end of the funnel so that a first portion of the mesh forms an inner funnel surface and a second portion of the mesh forms an outer funnel surface, and wherein the plurality of longitudinal tines are located between the inner funnel surface and the outer funnel surface.

[0202] 15. The system of any one of items 1-14, further comprising a lubrication sleeve disposed over at least a portion of the funnel.

[0203] 16. The system according to any one of items 1-15 further includes an intermediate catheter, wherein the flip support catheter is at least partially slidably disposed in a cavity of the intermediate catheter.

[0204] 17. The system according to any one of items 1-16, further comprising a retractor disposed within the catheter lumen, wherein the first region of the flexible tube is coupled to a distal region of the retractor.

[0205] 18. A thrombectomy system comprising:

[0206] a flip support catheter having an elongated and 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 that communicates with an interior of the funnel and the catheter lumen, respectively, and wherein at least a proximal portion of the funnel adjacent the catheter body includes an opening configured to allow passage of a fluid;

[0207] a retractor disposed in the catheter lumen; and

[0208] a flexible tube formed of a knitted or braided material, the flexible tube being turned over the distal end of the funnel and having a first region attached to the retractor and a second region extending at least partially over the outer surface of the funnel, wherein the flexible tube is configured to be pulled proximally into the catheter lumen by pulling the retractor proximally so that the second region of the flexible tube passes through the interior of the funnel and accordingly enters the catheter lumen.

[0209] 19. A thrombectomy system comprising:

[0210] A flip support catheter having an elongated and 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 that communicates with an interior of the funnel and, in turn, with the catheter lumen, and wherein at least a proximal end of the funnel adjacent the catheter body includes an opening configured to allow passage of a fluid; and

[0211] a flexible tube that is knitted, the flexible tube flipped over the distal end of the funnel and having a first region and a second region, the first region being at least partially disposed within the interior of the funnel and the second region extending at least partially over the exterior of the funnel, wherein the flexible tube is configured to be pulled proximally into the catheter lumen by pulling the first region of the flexible tube proximally such that the second region of the flexible tube flips over the distal end of the funnel when the flexible tube is pulled into the interior of the funnel and, respectively, the catheter lumen, and wherein the funnel is configured such that pulling the first region of the flexible tube proximally applies an axial load on the funnel that expands the funnel into an expanded and jammed configuration.

[0212] 20. A method of removing a clot from a blood vessel, the method comprising:

[0213] Advancing a flip tube device through a blood vessel until a distal end portion of the flip tube device is positioned proximate to a clot, wherein the flip tube device comprises a flip support catheter having an elongated and flexible catheter body, an interior catheter lumen, and an expandable funnel disposed at a distal end of the catheter body, wherein the distal end of the funnel defines an opening communicating with an interior of the funnel and correspondingly with the catheter lumen, the flip tube device further comprising a flexible tube flipped over the distal end of the expandable funnel, and the flexible tube having a first region and a second region, the first region being at least partially disposed within the interior of the funnel and the second region extending at least partially over an outer surface of the funnel;

[0214] expanding the funnel from a collapsed delivery configuration to an expanded configuration in the vicinity of a clot within a blood vessel; and

[0215] The first region of the flexible tube is pulled proximally, thereby flipping the second region of the flexible tube over the distal end of the funnel, causing the flexible tube to capture clot and pull the clot proximally into the interior of the respective funnel and the catheter lumen.

[0216] 21. The method of item 20, wherein capturing the clot and pulling the clot proximally into the interior of the respective funnel and the catheter lumen comprises compressing the clot and releasing fluid from the clot laterally out of a fluid outlet opening in a proximal portion of the funnel.

[0217] 22. The method of item 20 further comprises selecting a size of the inversion tube device based on a size of the blood vessel.

[0218] 23. The method of clause 20, wherein pulling the first region of the flexible tube proximally to cause the second region of the flexible tube to flip over the distal end of the funnel causes the funnel to assume a stuck configuration.

[0219] 24. The method of item 20, wherein in the expanded configuration, the expandable funnel has an outer diameter that is greater than at least 1 / 3 of the width of the clot.

[0220] 25. The method of clause 20, wherein in the expanded configuration, the expandable funnel has an outer diameter that is at least 50% greater than the width of the clot.

[0221] 26. The method of item 20, wherein pulling the first region of the flexible tube proximally to cause the second region of the flexible tube to flip over the distal end of the funnel comprises applying a compressive force of between 500 g and 3000 g on the funnel.

[0222] 27. The method of item 20, wherein expanding the funnel comprises extending the expandable funnel distally out of the intermediate catheter.

[0223] 28. The method according to item 20 further includes removing the flexible tube from the catheter cavity and loading a new flexible tube onto the flip support catheter.

[0224] 29. The method of item 20, wherein expanding the funnel comprises allowing the funnel to self-expand.

[0225] 30. The method of clause 20, wherein expanding the funnel comprises pulling the first region of the flexible tube proximally to expand the funnel.

[0226] 31. A thrombectomy device comprising:

[0227] A flip support catheter having an expandable funnel at the distal end of a flexible elongated catheter body, the funnel comprising:

[0228] a first flexible tube made of a knitted or braided material, the first flexible tube everted upon itself to form an inner funnel surface and an outer funnel surface, the inner funnel surface defining an interior of the funnel, the interior of the funnel communicating with a lumen of the catheter extending through the catheter body, and

[0229] a plurality of support tines extending distally from a distal end of the catheter body between the inner funnel surface and the outer funnel surface, wherein the respective inner funnel surface and the outer funnel surface are configured to slide axially relative to the support tines;

[0230] as well as

[0231] a second flexible tube made of a knitted or braided material, the second flexible tube extending distally along at least a portion of the outer surface of the catheter body and the outer funnel surface, respectively, and turning over the distal end of the funnel into the interior of the funnel and the catheter lumen, respectively,

[0232] Wherein the funnel is configured to expand to a stuck configuration when the second flexible tube is pulled proximally into the catheter lumen.

[0233] 32. The device of item 31, wherein the first flexible tube comprises a braided material.

[0234] 33. The device according to item 31 or 32, wherein when the funnel is in the jammed configuration, the first flexible tube has a braid angle greater than 90 degrees.

[0235] 34. A device according to any one of items 31-33, wherein the plurality of tines are formed by a distal portion of the catheter body.

[0236] 35. A device according to any one of items 31-34, wherein the funnel further comprises one or more circumferential supports extending circumferentially around one or both of the inner funnel surface and the outer funnel surface to constrain the outer periphery of the funnel.

[0237] 36. A device according to item 35, wherein the one or more circumferential supports include one or more of yarns, threads, sutures and sewing threads.

[0238] 37. A device according to item 35, wherein the one or more circumferential supports comprise suture material.

[0239] 38. The device of any one of items 35-37, wherein the one or more circumferential supports connect the inner funnel surface to the outer funnel surface.

[0240] 39. A device according to any of items 35-38, wherein the one or more circumferential supports extend helically around the funnel.

[0241] 40. The device of any one of items 31-39, wherein each tine of the plurality of tines folds back upon itself.

[0242] 41. A device according to any one of items 31-40, wherein each tine of the plurality of tines is connected to a respective circumferentially adjacent tine.

[0243] 42. A device according to any one of items 31-41, wherein when the funnel is expanded to the blocking configuration, the distal end of the funnel extends no more than 5 mm from the distal ends of the plurality of tines.

[0244] 43. A device according to item 42, wherein when the funnel is expanded to the jammed configuration, the distal end of the funnel extends no more than 1 mm from the distal ends of the plurality of tines.

[0245] 44. A device according to any one of items 31-43, wherein the second flexible tube comprises a knitted material.

[0246] 45. The device according to any one of items 31-44, further comprising a retractor extending through the catheter lumen, and the retractor has a distal end coupled to the first end of the second flexible tube.

[0247] 46. ​​A device according to any one of items 31-45, wherein the shape of the funnel is configured so that the outer diameter of the inner funnel surface is smaller than the inner diameter of the outer funnel surface to form a space between the inner funnel surface and the outer funnel surface, and the multiple pointed teeth are arranged in the space.

[0248] 47. A thrombectomy device comprising:

[0249] A flip support catheter having an expandable funnel at the distal end of a flexible elongated catheter body, the funnel comprising:

[0250] a first flexible tube made of a knitted or braided material, the first flexible tube inverted upon itself to form an inner funnel surface and an outer funnel surface, the inner funnel surface defining an interior of the funnel, the interior of the funnel communicating with a lumen of the catheter extending through the catheter body,

[0251] a plurality of support tines extending distally from a distal end of the catheter body between the inner funnel surface and the outer funnel surface, wherein the respective inner funnel surface and the outer funnel surface are configured to slide axially relative to the support tines, and

[0252] one or more circumferential supports extending circumferentially around one or both of the inner funnel surface and the outer funnel surface, constraining an outer periphery of the funnel;

[0253] as well as

[0254] A second flexible tube is made of a knitted or braided material, the second flexible tube extends distally along at least a portion of the outer surface of the catheter body and the outer funnel surface, respectively, and turns over at the distal end of the funnel to enter the interior of the funnel and the catheter cavity accordingly.

[0255] 48. The device of clause 47, wherein the one or more circumferential supports connect the inner funnel surface to the outer funnel surface.

[0256] 49. A thrombectomy system comprising:

[0257] an inverted support catheter having an elongated and flexible catheter body, a catheter lumen, and an expandable funnel at a distal end of the catheter body, wherein the distal end of the funnel defines an opening that communicates with an interior of the funnel and, in turn, with the catheter lumen;

[0258] a first flexible tube made of a knitted or braided material, the first flexible tube extending distally along at least a portion of an outer surface of the catheter body and an outer surface of the funnel, respectively, wherein at least a portion of the first flexible tube is turned over the distal end of the funnel and enters the interior of the respective funnel and the catheter lumen, respectively; and

[0259] A tear sleeve extends over the first flexible tube and over at least a distal portion of the inversion support catheter, the tear sleeve being configured to be removed from the first flexible tube by tearing along a length of the tear sleeve when the inversion support catheter and the first flexible tube are loaded into a delivery catheter.

[0260] 50. The system of item 49, further comprising a loading sleeve and configured such that the distal portion of the flip support catheter can be loaded into the loading sleeve, wherein the funnel is constrained in a collapsed configuration.

[0261] 51. The system according to item 50 further includes a delivery catheter, wherein the loading sleeve is constructed to be inserted into the proximal end of the delivery catheter so that the flip support catheter and the first flexible tube can extend distally into the delivery catheter.

[0262] 52. The system of any one of items 49-51, further comprising a second flexible tube made of a knitted or braided material, the second flexible tube being configured to be inserted onto the flip support catheter.

[0263] 53. The system according to any one of items 49-52, further comprising a retractor disposed within the catheter lumen, wherein an end of the first flexible tube is coupled to the retractor.

[0264] 54. The system according to any one of items 49-53 further includes a stopper disposed on a proximal region of the outer surface of the catheter body, wherein the stopper is constructed to prevent the first flexible tube from extending above the outer surface of the catheter body proximal to the stopper.

[0265] 55. The system of any of items 49-54, further comprising an elastic cuff disposed on the proximal end of the first flexible tube.

[0266] 56. The system of any one of items 49-55, further comprising a locking member configured to lock the flip support catheter to the delivery catheter.

[0267] 57. A thrombectomy system comprising:

[0268] an inverted support catheter having an elongated and flexible catheter body, a catheter lumen, and an expandable funnel at a distal end of the catheter body, wherein the distal end of the funnel defines an opening that communicates with an interior of the funnel and, in turn, with the catheter lumen;

[0269] a first flexible tube made of a knitted or braided material, the first flexible tube extending distally along at least a portion of an outer surface of the catheter body and an outer surface of the funnel, respectively, wherein at least a portion of the first flexible tube is turned over the distal end of the funnel and enters the interior of the respective funnel and the catheter lumen, respectively; and

[0270] A loading sleeve, wherein the distal portion of the inverted support catheter is capable of being loaded into the loading sleeve, wherein the funnel is constrained in a collapsed configuration, and wherein the loading sleeve includes a tear line configured to separate the loading sleeve and remove the loading sleeve from over the inverted support catheter.

[0271] 58. The system according to item 57 also includes a tear sleeve extending over the first flexible tube and over at least a distal portion of the flip support catheter, and the tear sleeve is constructed to be removed from the first flexible tube by tearing along the length of the tear sleeve when the flip support catheter and the first flexible tube are loaded into the delivery catheter.

[0272] 59. A system according to item 58, wherein the loading sleeve is constructed to be inserted into the proximal end of the delivery catheter so that the flip support catheter and the first flexible tube can extend distally into the delivery catheter.

[0273] 60. The system of any one of items 57-59, further comprising a second flexible tube made of a knitted or braided material, the second flexible tube being configured to be inserted onto the flip support catheter.

[0274] 61. The system according to any one of items 57-60, further comprising a retractor disposed within the catheter lumen, wherein an end of the first flexible tube is coupled to the retractor.

[0275] 62. The system according to any one of items 57-61 further includes a stopper disposed on a proximal region of the outer surface of the catheter body, wherein the stopper is constructed to prevent the first flexible tube from extending above the outer surface of the catheter body proximal to the stopper.

[0276] 63. The system of any of items 57-62, further comprising an elastic cuff disposed on the proximal end of the first flexible tube.

[0277] 64. The system of any one of items 57-63, further comprising a locking member configured to lock the flip support catheter to the delivery catheter.

Claims

1. A thrombectomy system, comprising: A flip support catheter having an elongated and flexible catheter body, a catheter lumen, and an expandable funnel disposed at a distal end of the catheter body, wherein the funnel comprises a filament and a plurality of longitudinal struts extending from the distal end of the catheter body, each longitudinal strut having a distal end, each longitudinal strut folded back so that the distal end of each strut is blunt, the filaments being attached at or near the distal ends of the plurality of longitudinal struts where the struts are folded back to radially connect the plurality of longitudinal struts, wherein the distal end of the funnel defines a distal opening, the distal opening being in communication with an interior of the funnel and correspondingly with the catheter lumen; a flexible tube that is flipped over the distal end of the funnel such that the flexible tube has a first region at least partially disposed within the interior of the funnel and a second region that extends at least partially over the exterior of the funnel, wherein the flexible tube is configured to be pulled proximally into the catheter lumen by pulling the first region proximally such that the second region flips over the distal end of the funnel when the flexible tube is pulled into the catheter lumen, and A retractor is disposed within the catheter lumen, wherein the first region of the flexible tube is coupled to a distal region of the retractor.

2. A system according to claim 1, wherein a portion of the second region of the flexible tube extends at least partially above the outer surface of the catheter body proximal to the funnel, and wherein the inner diameter of the portion of the second region extending above the outer surface of the catheter body is less than the maximum outer diameter of the funnel when the funnel is in an expanded configuration.

3. The system of claim 1, wherein the funnel has a collapsed configuration having a maximum outer diameter that is less than 0.3 times the outer diameter of the catheter body proximal to the funnel.

4. The system of claim 1, wherein the funnel has an expanded configuration in which the funnel has a minimum outer diameter that is greater than 2 times the outer diameter of the catheter body proximal to the funnel.

5. The system of claim 4, wherein the funnel has an outer diameter of between 2 mm and 26 mm in the expanded configuration.

6. The system of claim 1, wherein the flexible tube comprises a knitted tube.

7. The system of claim 6, wherein the knitted tube has more than 10 loops for each cross section through the knitted tube along its length.

8. The system of claim 1, wherein the plurality of longitudinal struts are continuous with the catheter body proximal to the funnel.

9. A system according to claim 8, wherein the funnel also includes a mesh, which is flipped over on itself at the distal end of the funnel so that a first portion of the mesh forms an inner funnel surface and a second portion of the mesh forms an outer funnel surface, and wherein the plurality of longitudinal struts are located between the inner funnel surface and the outer funnel surface.

10. The system of claim 1, further comprising a lubrication sleeve disposed over at least a portion of the funnel.

11. The system of claim 1, further comprising an intermediate catheter, wherein the flip support catheter is at least partially slidably disposed within a lumen of the intermediate catheter.

12. The system of claim 1, wherein a base region of the funnel adjacent the distal end of the catheter body includes an opening configured to allow fluid to pass therethrough.

13. The system of claim 12, wherein the opening forms a plurality of circumferentially arranged holes at the base region of the funnel adjacent the distal end of the catheter body.

14. The system of claim 1, wherein the funnel is configured such that pulling the first region of the flexible tube proximally exerts an axial compressive force on the funnel that expands the funnel into an expanded configuration.

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