Recanalization devices and related systems and methods

Abstract

Provided herein is a recanalization system including (i) a handle located at a proximal end of the system, (ii) a first elongated member, (iii) a second elongated member, the first and second elongated members being movable relative to one another, and (iv) a recanalization device located at a distal end of the system. The recanalization device includes (i) a first end portion coupled to the first elongated member, (ii) a second end portion coupled to the second elongated member, and (iii) at least one strut extending between the first and second end portions. The recanalization device is configured to (i) selectively expand and compress radially and (ii) move axially relative to the first and second elongated members.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 63 / 375,682, filed September 14, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The field of the disclosure relates generally to recanalization devices, and more particularly to recanalization devices configured to recanalize occluded vessel segments, especially chronically occluded vessel segments. [Background technology]

[0003] Post-thrombotic syndrome (PTS) is a serious condition that can occur after a patient has a blood clot (e.g., deep vein thrombosis or DVT) and includes pain, swelling, and other symptoms resulting from the clot material still present in the patient's vasculature. Furthermore, the longer the clot material remains in the patient's vasculature, the more it hardens, making it more difficult for therapeutic agents and devices to remove. This hardening can further worsen the symptoms of PTS. Therefore, treatments for chronically occluded vasculature include symptom management, endophlebectomy, or complete vein removal (invasive procedures).

[0004] Current systems / devices for removing clot material limit the user's control over the removal process. For example, U.S. Patent Nos. 10,779,852 (hereinafter, "the '852 patent") and 11,406,418 (hereinafter, "the '418 patent") describe current thrombus removal devices. The thrombus removal devices include a self-adjusting cage whose resistance mechanism is adjusted without any user input other than the user's movement to move the device along the blood vessel. Thus, the diameter of the self-adjusting cage is dependent on the diameter of the blood vessel.

[0005] In view of the above, there is a need for a recanalization system that allows the user to control the expansion and contraction of the recanalization device. Summary of the Invention [Means for solving the problem]

[0006] In one aspect, a recanalization system is provided that includes a handle located at a proximal end of the system, a first elongated member, a second elongated member, and a recanalization device located at a distal end of the system. The handle includes an actuator. The first elongated member is movable relative to the second elongated member. The recanalization device includes a first end portion coupled to the first elongated member, a second portion coupled to the second elongated member, and at least one strut extending between the first and second end portions. The actuator is configured to move the first end portion toward the second end portion to expand each of the at least one strut, and the recanalization device is configured to move relative to the first and second elongated members.

[0007] In another aspect, a method for recanalization is provided, the method including (i) intravascularly advancing multiple elongate members of a recanalization system to a target location within a patient, (ii) radially expanding a recanalization device of the recanalization system to engage the target location, (iii) axially moving the recanalization device to remove clot material at the target location, and (iv) withdrawing the multiple elongate members of the recanalization system from the patient.

[0008] In yet another aspect, a recanalization device is provided that includes: (i) first and second ends and a center between the first and second ends, the first and second ends spaced apart along an axis and movable toward and away from the center of the recanalization device; (ii) at least one strut member extending away from each of the first and second ends and terminating in an apex member; and (iii) diamond-shaped cell struts extending between and integral with the two apex members. Each diamond-shaped cell strut includes (i) opposing outwardly facing edges and (ii) a number of teeth located along each edge.

[0009] Various refinements of the features described in connection with the above-described aspects exist. Additional features may also be incorporated into the above-described aspects. These refinements and additional features may exist individually or in any combination. For example, the various features discussed below in connection with any of the illustrated embodiments may be incorporated into any of the above-described aspects, alone or in any combination.

[0010] As used herein, unless the context clearly dictates otherwise, "a," "an," and "the" refer to both singular and plural references.

[0011] As used herein, including in the claims, the term "or" is used to mean "and / or," unless expressly indicated to refer to alternatives only or to alternatives that are mutually exclusive.

[0012] As used herein, the term "about" refers to a measurable value such as a parameter, including a quantity, temporal duration, and the like, and is intended to include a variation of ±15% or less, preferably a variation of ±10% or less, more preferably a variation of ±5% or less, even more preferably a variation of ±1% or less, and even more preferably a variation of ±0.1% or less of a particularly recited value, insofar as such variations are appropriate for practicing the invention described herein. It is further understood that the values ​​referred to by the modifier "about" are themselves specifically disclosed herein.

[0013] As used herein, spatially relative terms, such as "beneath," "below," "lower," "above," "upper," "front," "back," "side," "left," "right," "rear," etc., are used for ease of description and to describe the relationship of one element or feature to another. It is further understood that the terms "front," "back," "left," and "right" are not intended to be limiting and are intended to be interchangeable where appropriate. It should further be noted that the terms "first," "second," and the like, used herein, do not denote any order, quantity, or relative importance, but rather are used to distinguish one element from another.

[0014] As used herein, terms such as "comprise", "comprising", and the like specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0015] As used herein, terms such as "configure" and "configuring" refer to a component and / or assembly capability, but do not preclude the presence or addition of other capabilities, features, components, elements, operations, and any combination thereof.

[0016] Chemical compounds are described using standard nomenclature, e.g., any position not substituted by any shown group is understood to have its valency filled by the shown bond or hydrogen atom.

[0017] All ranges disclosed herein are inclusive of the endpoints, and the endpoints are independently combinable with each other. Each range disclosed herein constitutes a disclosure of any point or subrange within the disclosed range.

[0018] All methods described herein can be performed in any suitable order unless otherwise indicated herein or clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., "etc.") is intended merely to better illustrate the invention and does not pose a limitation on the scope of the invention or any embodiment thereof unless otherwise claimed.

[0019] Any combination or permutation of the features, functions, and / or embodiments disclosed herein is contemplated. Additional advantageous features, functions, and applications of the disclosed systems, methods, and assemblies of the present disclosure will become apparent from the following description, particularly when read in conjunction with the accompanying figures. All references cited in this disclosure are incorporated herein by reference in their entirety.

[0020] Features and aspects of the embodiments are described below with reference to the accompanying drawings, in which elements are not necessarily drawn to scale, and in which corresponding reference characters indicate corresponding parts throughout the several views of the drawings.

[0021] Exemplary embodiments of the present disclosure are further described with reference to the accompanying drawings, in which it is noted that the various features, steps, and combinations of features / steps described below and illustrated in the figures can be arranged and configured differently to produce embodiments that are within the scope of the present disclosure.

[0022] To assist those skilled in the art in making and using the disclosed assemblies, systems and methods, reference is made to the accompanying drawings. [Brief explanation of the drawings]

[0023] [Figure 1A] FIG. 1A is a side perspective view of a recanalization system according to an embodiment of the present disclosure. [Figure 1B] FIG. 1B is a side cross-sectional view of the recanalization system of FIG. 1A according to an embodiment of the present disclosure. [Figure 2A] FIG. 2A is a side view of a recanalization system according to an embodiment of the present disclosure. [Figure 2B] 2B is a side cross-sectional view of the recanalization system of FIG. 2A with the recanalization device in a first position according to an embodiment of the present disclosure. [Figure 2C] 2C is a side cross-sectional view of the recanalization system of FIG. 2A with the recanalization device in a second position according to an embodiment of the present disclosure. [Figure 2D] FIG. 2D is an expanded view of the trigger of the recanalization system of FIG. 2B in accordance with an embodiment of the present disclosure. [Figure 2E] FIG. 2E is an enlarged view of a lead screw of the recanalization system of FIG. 2B in accordance with an embodiment of the present disclosure. [Figure 2F] FIG. 2F is a detailed view of a biasing member of the recanalization system of FIG. 2B in accordance with an embodiment of the present disclosure. [Figure 3A] FIG. 3A is a perspective view of a recanalization system according to an embodiment of the present disclosure. [Figure 3B] 3B is an enlarged perspective view of the recanalization system of FIG. 3A in accordance with an embodiment of the present disclosure. [Figure 3C] 3C is a perspective cross-sectional view of the recanalization system of FIG. 3A according to an embodiment of the present disclosure. [Figure 3D] FIG. 3D is a detailed view of a biasing member of the recanalization system of FIG. 3C in accordance with an embodiment of the present disclosure. [Figure 4] FIG. 4 is a side perspective view of a recanalization device of the recanalization system of FIGS. 1A-3D according to an embodiment of the present disclosure. [Figure 5A] FIG. 5A is a side perspective view of a recanalization device of the recanalization system of FIGS. 1A-3D according to an embodiment of the present disclosure. [Figure 5B] 5B is a partial enlarged cross-sectional view of the recanalization device of FIG. 5A according to an embodiment of the present disclosure. [Figure 6] FIG. 6 is a partial enlarged perspective view of the recanalization device of FIG. 5A in accordance with an embodiment of the present disclosure. [Figure 7A] 7A is a partial enlarged perspective view of the recanalization device of FIG. 5A in accordance with an embodiment of the present disclosure. [Figure 7B] 7B is a partial enlarged cross-sectional view of the recanalization device of FIG. 7A in accordance with an embodiment of the present disclosure. [Figure 8A] FIG. 8A is a perspective view of a portion of a diamond-shaped cell strut of the recanalization device of FIGS. 4-7B in accordance with an embodiment of the present disclosure. [Figure 8B] FIG. 8B is a perspective view of a portion of another diamond-shaped cell strut of the recanalization device of FIGS. 4-7B in accordance with an embodiment of the present disclosure. [Figure 9A] FIG. 9A is a side perspective view of a recanalization device of the recanalization system of FIGS. 1A-3D in a first position according to an embodiment of the present disclosure. [Figure 9B] FIG. 9B is a side perspective view of the recanalization device of the recanalization system of FIGS. 1A-3D in a second position according to an embodiment of the present disclosure. [Figure 10] FIG. 10 is an illustration of an exemplary method associated with the recanalization system of FIGS. 1A-3D, according to an embodiment of the present disclosure. [Figure 11] FIG. 11 is a side perspective view of an embodiment of an elongate member associated with the recanalization system of FIGS. 1A-3D, in accordance with an embodiment of the present disclosure. [Figure 12] FIG. 12 is a side perspective view of an embodiment of a recanalization device associated with the recanalization system of FIGS. 1A-3D, according to an embodiment of the present disclosure. [Figure 13] FIG. 13 is a perspective view of an embodiment of a recanalization device associated with the recanalization system of FIGS. 1A-3D, according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0024] The present disclosure is generally directed to recanalization systems and devices, and related systems and methods, for recanalizing venous segments (e.g., severely chronically occluded venous segments, including iliofemoral venous segments) in patients, such as patients suffering from post-thrombotic syndrome (PTS). The recanalization systems and devices may be used by a user (e.g., a physician, clinician, or other trained provider) to treat the user's occluded venous segment.

[0025] In some embodiments described herein, a recanalization system for engaging and removing clot material from a chronically occluded vasculature of a patient includes: (i) a handle; (ii) a recanalization device; and (iii) a plurality of elongate members. The recanalization device is configured to be deployed within the patient's vasculature and includes a first end portion (e.g., a distal portion), a second end portion (e.g., a proximal portion), and at least one strut extending between the first and second end portions.

[0026] Once expanded within the vasculature, the recanalization device, and more specifically, the at least one strut, can (i) translate axially within the vasculature and / or (ii) rotate to engage and remove clot material. In some embodiments, the at least one strut includes teeth and / or edge modifications specifically configured to engage with aged clot material to disrupt the material without the need for a retrieval bag or suction device to remove the material from the patient.

[0027] The devices, systems, and methods described herein include technical advantages over known devices, systems, and methods. Specifically, the devices, systems, and methods described herein include at least the technical advantages of (i) control of the diameter defined by the recanalization device struts to selectively apply radial force and enable gradual treatment, (ii) recanalization device struts with higher radial force and sharp and / or serrated elements for better clot engagement, (iii) at least two independent elongate members (e.g., steerable shafts or catheters) for ease of use and rapid element retraction and expansion, (iv) enabling 360° circumferential treatment for more effective clot removal, and (v) having dual elongate members formed of solid nitinol hypotubing for flexibility, pushability, torqueability, and kink resistance.

[0028] To fully understand the various embodiments of the present technology, a certain level of detail will be provided in the following descriptions of FIGS. 1A - 13. In other instances, well-known structures, materials, operations, and / or systems related to intravascular procedures, stents, blood clots and removal techniques for occluded vein segments, catheters, etc. are not shown in detail or described in the following disclosure to avoid unnecessarily obscuring the description of the various embodiments of the present disclosure. However, those skilled in the art will recognize that the present disclosure can be implemented without one or more of the details described herein and / or with other structures, methods, components, etc.

[0029] The terms used hereinafter should be interpreted in the broadest reasonable manner, even though they are used in conjunction with a detailed description of specific examples of embodiments of the present disclosure. In fact, any term that may be emphasized hereinafter and is intended to be interpreted in any restricted manner is clearly and specifically defined as such in this section.

[0030] The accompanying figures illustrate embodiments of the present disclosure and are not intended to limit its scope unless explicitly stated otherwise. The sizes of the various illustrated elements are not necessarily drawn to scale, and these various elements may be enlarged to improve readability. Details of components may be represented in the figures to exclude details such as the position of components and specific exact connections between such components when the details of the components are not necessary for a complete understanding of how the technology is made and used. Many of the details, dimensions, angles, and other features shown in the figures are merely illustrative of specific embodiments of the present disclosure. Thus, other embodiments may have other details, dimensions, angles, and features without departing from the technology. Furthermore, those skilled in the art will understand that further embodiments of the present disclosure can be implemented without some of the details described below.

[0031] With respect to the terms "distal" and "proximal" herein, unless otherwise specified, the terms may refer to the relative position of portions of the catheter subsystem with reference to an operator and / or location within the vasculature. Also, as used herein, the terms "rear," "forward," "superior," "inferior," and the like are not intended to limit the referenced components to a particular orientation. It should be understood that such designations refer to the orientation of the referenced components as illustrated in the figures, and that the systems of the present disclosure can be used in any orientation suitable for the user.

[0032] 1A-3D , in the illustrated embodiment, system 100 extends from a proximal end 102 to a distal end 104. Proximal end 102 includes a handle 106 operably coupled to a recanalization device 108 located at distal end 104 via an inner elongate member 110 (also referred to herein as a first elongate member) and an intermediate elongate member 112 (also referred to herein as a second elongate member). Inner elongate member 110 may extend through a lumen of intermediate elongate member 112 (collectively “elongate members 110, 112”) such that inner elongate member 110 and intermediate elongate member 112 are coaxial. System 100 further includes an outer elongate member 114 (e.g., a suction catheter, guide catheter, or delivery catheter), with elongate members 110, 112 extending at least partially through outer elongate member 114 such that inner elongate member 110, middle elongate member 112, and outer elongate member 114 (collectively, elongate members 110, 112, 114) are coaxial (or nearly coaxial) with respect to the longitudinal axis (L). In other embodiments, elongate members 110, 112 are not coaxial, but instead can extend side by side and / or through separate lumens in outer elongate member 114.

[0033] In the exemplary embodiment, elongate members 110, 112 comprise hypotubes and are formed of nitinol to improve the responsiveness, flexibility, kink resistance, and pushability of system 100. Additionally, in the exemplary embodiment, outer elongate member 114 comprises a braided / coiled reflow structure with a low crossover profile. In other embodiments, elongate members 110, 112, 114 may comprise catheters, tubing (e.g., hypotubes and laser-cut hypotubes), cables (e.g., helical hollow strand cables), sheaths, shafts (e.g., torque shafts), and / or the like, and elongate members 110, 112, 114 may be formed from metals (e.g., stainless steel, nitinol, cobalt chrome), braided / coiled reflow structures, plastics, fluoropolymers (e.g., polytetrafluoroethylene (PTFE)), polymers, and / or other suitable materials.

[0034] The outer elongated member 114 includes a distal portion 115A and a proximal portion 115B. The proximal portion 115B may be directly or indirectly coupled to a tubing assembly 116 (e.g., including one or more tubing, fluid control devices, and / or the like) via a valve device 118. The valve device may include a disconnect 148 for the outer elongated member 114. Specifically, the disconnect 148 is configured to allow a user to quickly disconnect the outer elongated member 114 from the handle 106. In some embodiments, the tubing assembly 116 can be used to flush the lumen of the outer elongated member 114 through the side port 120. In some embodiments, the handle 106 is movable (translatable, rotatable) relative to the valve device 118 and the outer elongated member 114.

[0035] 1A-3D , the handle 106 is advanced toward the valve device 118 such that the recanalization device 108 extends from the distal portion 115A of the outer elongate member 114. In some embodiments, the handle 106 can be retracted away from the outer elongate member 114, and / or the outer elongate member 114 can be advanced away from the handle 106 such that the recanalization device 108 is captured / positioned within the outer elongate member 114. When the recanalization device 108 is captured within the lumen of the outer elongate member 114, the recanalization device 108 is in a radially compressed state. In some embodiments, the recanalization device 108 can be positioned within the outer elongate member 114 during delivery of the system 100 through the patient's vasculature.

[0036] In the illustrated embodiment, the system 100 includes a tip 122 located at the distal end 104 of the system 100 and may be coupled, directly or indirectly, to the recanalization device 108 and / or the inner elongate member 110. The tip 122 may be removably attached, directly or indirectly, to the recanalization device 108 and / or the inner elongate member 110. In some examples, the tip 122 may be semi-permanently or permanently attached, directly or indirectly, to the recanalization device 108 and / or the inner elongate member 110. The tip 122 may have an atraumatic shape configured to minimize or even prevent damage to the patient's vasculature (e.g., sized and shaped as a nosecone) as the system 100 is advanced therethrough, and the tip 122 may be formed of a polymer. In other embodiments, the tip 122 may be made of a material other than a polymer, may have a shape / configuration other than that described, or may be omitted entirely. In some embodiments, when recanalization device 108 is constrained within outer elongate member 114, tip 122 may engage distal portion 115A of outer elongate member 114 and may be shaped and sized to seal the lumen of outer elongate member 114. In some embodiments, tip 122 and inner elongate member 110 may define a lumen 125 configured (e.g., sized and shaped) to receive a guidewire (not shown) therethrough. System 100 may be advanceable / trackable over a guidewire.

[0037] 5B, tip 122 can include a proximal cavity 123 configured to directly or indirectly engage one or more elongate members 110, 112, 114 and / or recanalization device 108. Tip 122 can be directly or indirectly attached to inner elongate member 110 and / or recanalization device 108 using adhesives, welding, fasteners, crimping, press-fitting, and combinations thereof. Tip 122 can define a lumen 125 configured (e.g., sized and shaped) to receive a guidewire (not shown) therethrough. Lumen 125 can extend longitudinally through at least inner elongate member 110 and tip 122.

[0038] The system 100 may include an extension member 226 that may directly or indirectly engage at least the inner elongate member 110 and / or the tip 122. The extension member 226 may be removably attached to at least one of the inner elongate member 110 and the tip 122. In some instances, the extension member 226 may be semi-permanently (or permanently) attached to at least one of the inner elongate member 110 and the tip 122. The extension member 226 may directly or indirectly contact the recanalization device 108. The extension member 226 may define a sidewall created by a throughbore extending longitudinally from the proximal end to the distal end.

[0039] The extension member 226 may directly or indirectly engage with the recanalization device 108. The extension member 226 may define one or more features configured to engage with the recanalization device 108. For example, the extension member 226 may define one or more openings (not shown). The one or more openings may be positioned circumferentially about the outer surface of the extension member 226. The one or more openings may extend at least partially through the outer surface of the sidewall of the extension member 226. The recanalization device 108 may directly or indirectly engage with the one or more openings of the extension member 226.

[0040] In the illustrated embodiment, recanalization device 108 includes distal portion 109A and proximal portion 109B, inner elongate member 110 includes distal portion 111A and proximal portion 111B (see, e.g., FIGS. 1A-2C), and middle elongate member 112 includes distal portion 113A and proximal portion 113B (see, e.g., FIG. 1B). Distal portion 111A of inner elongate member 110 is coupled to distal portion 109A of recanalization device 108. Similarly, distal portion 113A of middle elongate member 112 is coupled to proximal portion 109B of recanalization device 108. 9A and 9B, relative movement of elongated members 110, 112 can longitudinally shorten / extend and radially expand / compress recanalization device 108 via relative movement of respective distal and proximal portions 109A, 109B of the recanalization device. Distal and proximal portions 109A, 109B of recanalization device 108 can be identical and can have a cylindrical or hub-like shape. In some embodiments, distal and proximal portions 109A, 109B are secured to elongated members 110, 112, respectively, via adhesives (e.g., adhesive bonding), welding, fasteners, crimping, and / or the like. For example, in some embodiments, one or both of distal and proximal portions 109A, 109B of recanalization device 108 can be directly welded to elongated members 110, 112.

[0041] As shown in Figures 1A-3D, handle 106 includes a housing 130 having a distal portion 131A and a proximal portion 131B and defining an internal chamber or lumen 132. For clarity, housing 130 is shown partially cut away in Figure 1B and in cross section in Figures 2B-2D. Proximal portions 111B, 113B of elongate members 110, 112, respectively, extend at least partially through housing 130.

[0042] In some embodiments, the handle 106 includes a port housing 134 operably (e.g., fluidly) coupled to a lumen of the inner elongate member 110 and / or the intermediate elongate member 112. The port housing 134 may define a port 135 extending outward from the handle 106 and operably (e.g., fluidly) coupled to a lumen of the inner elongate member 110 and / or the intermediate elongate member 112. The port housing 134 may define a lumen 137 extending between a proximal portion and a distal portion of the port housing 134, including the port 135. The lumen 137 may be configured to directly or indirectly engage the inner elongate member 110. In some examples, the inner elongate member 110 may be axially inserted into the lumen 137 of the port housing 134 relative to the longitudinal axis (L). The inner elongate member 110 may be configured to move (e.g., axially) relative to the port housing 134. During movement, the port housing 134 may remain fluidly connected to the inner elongate member 110 such that the port 135 may receive and / or deliver fluids into and / or from the inner elongate member 110. The axial length of the inner elongate member 110 positioned within the port housing 134 may be greater than the maximum distance of movement of the inner elongate member 110 during expansion / compression of the recanalization device 108.

[0043] The handle 106 includes a trigger mechanism 124 that includes a grip portion 126 and a linkage 128. As shown in FIGS. 1B and 2B-2D , the linkage 128 may be directly or indirectly coupled to the inner elongated member 110. The linkage 128 may be directly or indirectly coupled to an adapter 142, which may be directly or indirectly coupled to the inner elongated member 110. The adapter 142 may define a lumen 132 extending longitudinally between a proximal end and a distal end of the adapter 142. The lumen 132 may directly or indirectly engage with the inner elongated member 110 such that the adapter 142 is coupled to the inner elongated member 110. For example, the inner elongated member 110 may include and / or define a component / feature that engages with a portion of the lumen 132. 2D and 2F , the inner elongate member 110 includes a collar 145 coupled with the lumen 132 such that the inner elongate member 110 and the adapter 142 axially translate together. In one embodiment, the collar 145 may be fixedly attached (e.g., crimped, glued, welded, etc.) to the outer surface of the inner elongate member 110, and the collar 145 may be fixedly attached (e.g., crimped, glued, welded, etc.) to the lumen 132 of the adapter 142. The lumen 132 may define a tapered configuration such that the diameter of the tapered portion is equal to or smaller than the outer diameter of the inner elongate member 110. The tapered portion of the adapter 142 may engage ("grip") the outer surface of the inner elongate member 110.

[0044] The adapter 142 may further define a cavity 133 that may be axially oriented relative to the longitudinal axis (L) and the bore 132. The cavity 133 may extend circumferentially around the bore 132 of the adapter 142. The adapter 142 may be configured to directly or indirectly engage with the biasing member 127. The biasing member 127 may include, but is not limited to, a spring (e.g., a compression spring, a conical spring, a disc spring, an extension spring), a piston, rubber, an elastic band, and combinations thereof. In one example, the cavity 133 may be configured to directly or indirectly engage with the biasing member 127. The biasing member 127 may extend between the cavity 133 of the adapter 142 and an inner surface of the housing 130, the actuator 136, and / or the lead screw 140. For example, biasing member 127 can extend between cavity 133 of adapter 142 toward distal portion 131A of housing 130 .

[0045] The adapter 142 may be directly or indirectly coupled to an outer surface of the inner elongate member 110. The linkage 128 may be configured to translate movement of the gripping portion 126 of the trigger mechanism into axial movement of the adapter 142. For example, the linkage 128 may be configured to translate rotational movement of the gripping portion 126 into axial movement of the adapter 142 along the longitudinal axis (L). Upon actuation by the gripping portion 126 of the trigger mechanism 124, the linkage 128 advances the adapter 142 longitudinally toward the distal end 104 of the system 100. The adapter 142 is coupled to the inner elongate member 110 such that movement of the adapter at least partially translates the inner elongate member 110. In some instances, the inner elongate member 110 may translate relative to the intermediate elongate member 112.

[0046] 9A and 9B. When actuated, movement of the trigger mechanism advances the inner elongated member 110 such that the distal portion 111A of the inner elongated member 110 is displaced from an initial position (e.g., relative to the distal portion 113A of the middle elongated member 112). In one embodiment, the gripping portion 126 of the trigger mechanism 124 moves to actuate the linkage 128. Actuation of the linkage 128 urges the adapter 142 from its resting position, causing the adapter 142 to move axially along the longitudinal axis (L). The axial movement of the adapter 142 advances the distal portion 111A of the inner elongated member 110 from an initial position (e.g., relative to the distal portion 113A of the middle elongated member 112). Because the distal portion 111A of the inner elongate member 110 is coupled to the distal portion 109A of the recanalization device 108, the recanalization device 108 is retracted from the expanded position as the distal portion 111A of the inner elongate member 110 is advanced. That is, the inner elongate member 110 advances while the middle elongate member 112 remains relatively stationary. However, it should be understood that movement of the middle elongate member 112 is possible and does not depart from the spirit / scope of the present disclosure. When the gripping portion 126 is released by the user, the biasing member 127 urges the actuator 142 and linkage 128 back to their unactuated positions, thereby advancing the inner elongate member 110 axially toward the proximal portion 102. The distal portion 111A of the inner elongate member 110 then returns to its initial position, while the recanalization device 108 returns to the same expanded position it was in before the linkage 128 was activated.

[0047] The trigger mechanism 124 allows the recanalization device 108 to be easily adjusted between a first position and a second position (e.g., contracted and returned to its initial position), thereby enabling a user to easily and efficiently navigate a patient's vasculature. Specifically, because the recanalization device 108 can be contracted with the grip of the trigger mechanism 124 and quickly returned to its original position when the grip is released, the recanalization device 108 can be advanced or retracted through a constricted, dimensionally variable region within the patient's vasculature without the user having to manually expand the recanalization device 108 after navigation. Furthermore, the controllability of the recanalization device 108 is superior to recanalization systems that are reactive when moving through a constricted region. In other words, recanalization systems that are not user-adjustable simply rely on the deformability to move through a constricted region. At least one advantage of using a controllable recanalization device 108 is that the recanalization device 108 is less likely to damage the vasculature as the device moves through a stenotic region within a vessel. Additionally, the systems described herein allow a user to control the diameter of the recanalization device 108 and advance / retract the recanalization device 108 in a deflated state. Yet another potential benefit is that the user may not need an angiogram to determine the diameter of the recanalization device 108 after deflation. Yet another potential benefit is that the user may actuate the recanalization device 108 to grab / engage an obstruction on the vessel wall and release the obstruction from the wall.

[0048] Although the trigger mechanism 124 in the illustrated embodiment includes a linkage 128, a gripping portion, and an actuator 142, other mechanisms may be utilized to advance and retract the inner elongated member 110 as described herein. In other embodiments, the trigger mechanism 124 may be a shifter knob, a button, a pull pin, and / or other motion actuation mechanism. Additionally, in other embodiments, the trigger mechanism 126 may be coupled to the proximal portion 113B of the middle elongated member 112 instead of the proximal portion 111B of the inner elongated member 110.

[0049] As shown in FIGS. 2D and 2E , the recanalization system 100 may also allow for diameter adjustment of the recanalization device 108. The handle 106 further includes an actuator 136, an indicator scale 138 that indicates the relative amount of expansion of the recanalization device 108 (as described further herein), and a lead screw 140. The lead screw 140 is coupled to the proximal portion 113B of the intermediate elongate member 112. The lead screw 140 may have a threaded outer surface configured to couple with or mate with a threaded inner surface of the actuator 136. The actuator 136 extends outside the housing 130 from one or more openings 131 therein (e.g., a pair of openings 131 on opposite sides of the housing 130) such that the actuator 136 is accessible outside the housing 130 by a user. The actuator 136 is configured to threadably engage the lead screw 140 through a full range of travel to expand / contract the recanalization device 108. In the illustrated embodiment, the actuator 136 is a rotatable knob.

[0050] In some embodiments, the lead screw 140 defines an indicator (e.g., a tabbed feature) 139 that extends outward and may be positioned relative to the indicator scale 138. The indicator 139 may extend outward from the lead screw 140 in a direction perpendicular to the longitudinal axis (L). In some instances, the indicator 139 may extend outward and circumferentially (or semi-circumferentially) around the lead screw 140. In other instances, the indicator 139 may be directly or indirectly attached to the lead screw 140. During operation, as the lead screw 140 is advanced axially along the longitudinal axis (L) in either the distal or proximal direction, the indicator 139 may move axially in a direction corresponding to the lead screw 140. The indicator 139 may correlate with the indicator scale 138 to indicate the relative amount of expansion of the recanalization device 108. The display scale 138 may include features / elements that depict the expansion of the recanalization device 108 in scale format, for example, using alphanumeric characters, symbols, and combinations thereof. The features / elements may be positioned such that the indicator 139 is located at a point along the display scale 138 that corresponds to the relative expansion of the recanalization device 108.

[0051] Rotation of actuator 136 relative to housing 130 (e.g., by a user) can drive lead screw 140 to translate proximally and / or distally (e.g., between proximal and distal portions 131A, 131B of housing 130), thereby driving coupled middle elongate member 112 to translate relative to inner elongate member 110. This relative movement of elongate members 110, 112 increases / decreases the length of recanalization device 108 to radially contract / expand the length of recanalization device 108, respectively, as described in more detail below. For example, during radial expansion of the recanalization device 108, the proximal end 109B of the recanalization device 108 may be fixed or nearly fixed in position relative to the housing 130 (e.g., so as to allow minimal movement), and the distal end 109A of the recanalization device 108 may move toward the proximal end 109B such that the distance separating the distal end 109A and the proximal end 109B of the recanalization device 108 decreases from X1 to X2, as shown in Figures 9A and 9B, respectively. During radial contraction of the recanalization device 108, the proximal end 109B of the recanalization device 108 is fixed or nearly fixed in position relative to the housing 130 (e.g., allowing minimal movement), and the distal end 109A of the recanalization device 108 may move away from the proximal end 109B such that the distance separating the distal end 109A and the proximal end 109B of the recanalization device 108 increases from X2 to X1, as shown in Figures 9B and 9A, respectively. The extent of collapse and expansion of the recanalization device 108 can be monitored using a display provided by the display scale 138 for viewing by the user (as shown in Figures 1A and 3B).

[0052] In some embodiments, the recanalization system 100 may include a sealing cap 156. The sealing cap 156 may be attached, directly or indirectly, to the indicator 139 of the lead screw 140. Thus, the sealing cap 156 may be distal to the lead screw 140. In some embodiments, the handle 106 may include a flush port, opening, lumen, etc. In the illustrated embodiment, the handle 106 includes a flush port 146 for the middle elongated member 112. The flush port 146 may be in fluid communication with at least the sealing cap 156. The flush port 146 may be in fluid communication with the sealing cap 156 and at least one hole 158 in the middle elongated member 112. The flush port 146 may be configured to remove air from the middle elongated member 112 through the at least one hole 158 and the sealing cap 156.

[0053] The middle elongated member 112 may further define at least one hole 158 extending therethrough (FIGS. 2D and 2E). For example, the at least one hole 158 extends through the outer wall of the middle elongated member 112. In some instances, the middle elongated member 112 may include multiple holes 158. The holes 158 may be located at specific longitudinal positions along the length of the middle elongated member. At each longitudinal position, the holes may be further spaced circumferentially around the middle elongated member 112. For example, the holes 158 may be positioned in groups, with each group spaced about 90 degrees to about 120 degrees apart around the circumference of the middle elongated member 112. Each section may include approximately three holes, although more or fewer are acceptable. The holes 158 may be configured to evacuate air from the middle elongated member 112, for example, prior to introduction into a patient. The hole 158 may vent air into the distal inner cavity 143 of the lead screw 140. The distal inner cavity 143 may be in fluid communication with the sealing cap 156.

[0054] The lead screw 140 may further define a blocking member 152, an elongate member retainer 150, and a sealing device 154, each of which may be positioned within the proximal inner cavity 141 and axially relative to the longitudinal axis (L). The sealing device 154 may restrict fluid from moving between the distal inner cavity 143 and the proximal inner cavity 141. In some examples, the sealing device 154 may be positioned between the blocking member 152 and the elongate member retainer 150. The sealing device 154 may be an O-ring, a gasket, or the like. The sealing device 154 may define a throughbore sized and configured to allow the inner elongate member 110, the middle elongate member 112, or the inner elongate member 110 and the middle elongate member 112 to extend therethrough while still maintaining sealing properties between the distal inner cavity 143 and the proximal inner cavity 141.

[0055] The elongate member retainer 150 may be configured to directly or indirectly mate with one or more of the elongate members 110, 112, 114. The elongate member retainer may include a longitudinal bore for one or more of the elongate members 110, 112, 114 to extend therethrough. In some instances, the inner elongate member 110 may extend through the longitudinal bore. The elongate member retainer 150 is configured to directly / indirectly engage with the blocking member 152 and the sealing device 154. The elongate member retainer 150 may be configured to hold the blocking member 152 and the sealing device 154 in place relative to the adapter 140.

[0056] The blocking member 152 may be included along the length of the intermediate elongated member 112. The blocking member 152 may be configured to limit axial movement, rotational movement, or axial and rotational movement of the intermediate elongated member 112. The blocking member 152 may be made integral with and protrude outwardly from the intermediate elongated member 112. In some instances, the blocking member 152 may be attached to the intermediate elongated member 112. For example, the blocking member 152 may be fixedly attached to the intermediate elongated member 112. The blocking member 152 may be shaped to at least partially engage with the inner cavity 141 to limit movement of the intermediate elongated member 112. The blocking member 152 may be positioned within a corresponding recessed feature of the lead screw 140 such that movement of the blocking member 152 and the intermediate elongated member 112 is limited. Movement of the intermediate elongated member 112 may be limited to an axial movement corresponding to movement of the lead screw 140. Blocking member 152 may include a through hole so that at least inner elongate member 110 may extend therethrough.

[0057] 4 and 5A, the recanalization device 108 includes a center 202 between the distal end 109A and the proximal end 109B of the recanalization device. While the term center 202 is used, it should be appreciated that the center 202 may be located anywhere between the distal and proximal ends that enables the function of the recanalization device 108. The recanalization device 108 includes a plurality of support beams or struts 204 extending from each of the distal and proximal ends 109A, 109B toward the center 202. In the illustrated embodiment, three pairs of support struts 204 extend from the distal end 109A of the recanalization device 108 toward the center 202 of the recanalization device 108, and three pairs of support struts 204 extend from the proximal end 109B of the recanalization device 108 toward the center 202 of the recanalization device 108. More specifically, in the illustrated embodiment, the support struts 204 are generally similar or identical to one another and each extend from a first end 205A proximate either the distal end 109A or the proximal end 109B of the recanalization device 108 to a second end 205B proximate the center 202 of the recanalization device 108. Each pair of struts 204 is integrated with its respective first end 205A or second end 205B by a rib 203. The struts 204A and 204B are most clearly seen in FIGS. 5B and 6. Reference numerals 204A and 204B are used to identify specific struts 204 in FIGS. 4-6 for purposes of describing this illustrative embodiment. It will be appreciated that while the illustrated recanalization device 108 includes support struts 204 that are generally similar or identical to one another, the support struts 204 may be sized differently from one another without departing from the spirit / scope of the present disclosure. It will be understood that other struts 204 not specifically identified by 204A or 204B are similar to the identified struts 204A, 204B. Therefore, unless otherwise indicated, descriptions relating to struts 204A, 204B also apply to the other struts 204 of the recanalization device 108. As a result, reference number 204 will continue to be used to refer to struts 204.

[0058] Each pair of adjacent support struts 204 is connected at a single junction 206 that connects to the apexes 208 of the plurality of diamond-shaped cell struts 210. More specifically, the junction 206 is proximate the second ends 205B of the support struts 204, and the diamond-shaped cell struts 210 extend between (i) the second ends 205B of the support struts 204 extending proximally from the distal end 109A of the recanalization device 108, and (ii) the second ends 205B of the support struts 204 extending distally from the proximal end 109B of the recanalization device 108.

[0059] Adjacent support struts 204, for example, adjacent support struts 204A and 204B, may be positioned in a parallel configuration, such that support strut 204A is parallel to support strut 204B. In another embodiment, and as shown, support struts 204A and 204B may be in a non-parallel configuration. Specifically, support struts 204A and 204B may describe a triangular configuration. In one example, support struts 204A and 204B may be spaced further apart in the triangular configuration at first end 205A and closer together at second end 205B. In another example, support struts 204A and 204B may be spaced further apart in the triangular configuration at second end 205B and closer together at first end 205A. The triangular configuration of support struts 204A and 204B may provide increased stiffness and torque resistance to recanalization device 108.

[0060] In the illustrated embodiment, the pairs of support struts 204 provide more support to the center 202 and diamond cell struts 210 of the recanalization device 108 compared to support from a single support strut configuration because the pairs of support struts 204 are geometrically larger and therefore increase the second moment of inertia more than is possible for a single strut configuration. That is, by pairing the support struts 204, the pairs of support struts 204 provide greater support to the recanalization device 108 than a single strut configuration because the cross-sectional area provided by each pair of struts is increased relative to the cross-sectional area provided by a single strut. The pairs of support struts 204 also increase the torque resistance of the recanalization device 108 compared to a single strut configuration. Although six pairs of support struts 204 and six diamond cell struts 210 are shown in the illustrated embodiment, the recanalization device 108 may include additional or fewer pairs of support and diamond cell struts 204, 210 in other embodiments. Additionally, in other embodiments, the recanalization device 108 can include multiple support struts 204 having single or multiple support struts (e.g., single, double, triple, etc.) and diamond-shaped cell struts 210. Each diamond-shaped cell strut 210 is fabricated integrally with two apex members 208, and each diamond-shaped cell strut 210 has a high point 211 between its associated apex members 208. The high point 211 is located at a greater radial distance from the longitudinal axis L shown in FIG. 4 than the associated apex members 208.

[0061] In the illustrated embodiment, each diamond-shaped cell strut 210 includes a plurality of teeth 212 and edge modifications 214. The teeth 212 and edge modifications 214 (described in more detail with respect to FIGS. 8A and 8B ) are configured to engage clot material within the patient's vasculature. The teeth 212 are arranged in an alternating pattern. In another embodiment, the teeth 212 may be arranged in a continuous pattern. In the exemplary embodiment, some teeth 212 extend outward from a first edge 213A of the diamond-shaped cell strut 210, and other teeth 212 extend outward from a second edge 213B of the diamond-shaped cell strut 210. In the exemplary embodiment, the teeth 212 extend along the length of the diamond-shaped cell strut 210. The teeth 212 along each edge 213A, 213B are spaced apart. The teeth 212 along the second edge 213B are laterally aligned with the spaces separating adjacent teeth 212 along the first edge 213A. The teeth 212 are configured to add more surface area to the surface 216 of the diamond-shaped cell strut 210 and create an uneven surface along the surface 216, so that the recanalization device 108 has more opportunities to engage clot material in the patient's vasculature. Because the teeth 212 and edge modifications 214 are features added to the diamond-shaped cell strut 210, the teeth 212 and edge modifications 214 do not adversely affect the radial force of the recanalization device 108. In the illustrated embodiment, the teeth 212 are sized and shaped as trapezoids. In other embodiments, the teeth 212 may be sized and shaped as any other suitable shape, including, for example, triangles, semicircles, etc.

[0062] The recanalization device 108 may define a collar 220. The collar 220 may be connected, directly or indirectly, to one or more struts 204 at the distal portion 113A, the proximal portion 113B, or at the distal portion 113A and the proximal portion 113B. The collar 220 may have a cross-sectional shape, when viewed perpendicular to the longitudinal axis (L), that refers to a cylindrical, quadrilateral, triangular, and combinations thereof. The collar 220 may include and / or define features and / or components that extend, directly or indirectly, outwardly, inwardly, or outwardly and inwardly from and / or along the longitudinal axis (L). The collar 220 may be semi-permanently or permanently attached to one or more of the elongate members 110, 112, 114, the tip 122, the extension member 226, and combinations thereof. The collar 220 may be attached via adhesive (eg, adhesive bonding), welding, fasteners, crimping, and / or the like.

[0063] The recanalization device 108 may define one or more engagement members 222. Specifically, the collar 220 of the recanalization device 108 may define one or more engagement members 222. The engagement members 222 may extend laterally from the collar 220 toward the distal end 104. In certain embodiments, and as shown in FIGS. 5A-7B, the recanalization device 108 may define at least two engagement members 222. Reference numerals 222A and 222B are used in FIGS. 5A-7B to identify particular engagement members 222 for purposes of describing this illustrated embodiment. However, it should be understood that the engagement members 222A and 222B may be collectively referred to as 222. The engagement member 222A may oppose the engagement member 222B on either side of the longitudinal axis (L). The engaging member 222 can be configured to directly or indirectly engage with at least one of the elongate members 110, 112, 114, the tip 122, the extension member 226, and combinations thereof. In one embodiment, the engaging member 222 can be configured to removably engage with a corresponding feature / element of the extension member 226. In some instances, the engaging member 222 can be fixedly attached to the extension member 226 in a permanent or semi-permanent configuration. However, as discussed herein, the recanalization device 108 can be configured to expand and contract between a first position and a second position.

[0064] Each of the one or more engagement members 222 may define one or more tabs 224 and one or more tab arms 223. Engagement member 222A may define tab arm 223A extending outward from collar 220 toward distal end 104. A distal portion of tab arm 223A may define tab 224A. Engagement member 222B may define tab arm 223B extending outward from collar 220 toward distal end 104. A distal portion of tab arm 223B may define tab 224B. Reference numerals 223A and 223B are used in FIGS. 5A-7B to identify particular tab arms 223 for purposes of describing the illustrated embodiment. However, it should be understood that tab arms 223A and 223B may be collectively referred to as 223. Similarly, reference numerals 224A and 224B are used in Figures 5A-7B to identify particular tabs 224 for purposes of describing the illustrated embodiment. However, it should be understood that tabs 224A and 224B may be referred to collectively as 224.

[0065] The tab arms 223A and 223B can extend outward from the collar 220 toward the distal end 104 in a parallel, semi-parallel, and / or non-parallel configuration relative to the other tab arms and / or the longitudinal axis (L). In some instances, the tab arms 223A and 223B can extend outward from the collar 220 toward the distal end in a tapered configuration such that the tab arms 223A and 223B extend generally longitudinally from the collar 220, with the ends of the tab arms 223A and 223B separated by a radial distance that is less than the radial distance that separates the tab arms 223A and 223B that are integral with the collar 220. The tab arms 223A and 223B can be biased inward toward the longitudinal axis (L).

[0066] Tab arms 223A and 223B may each define a tab 224 near a distal end of each tab arm 223. Specifically, tab arm 223A may define tab 224A near its distal end, and tab arm 223B may define tab 224B near its distal end. Tabs 224A and 224B may be configured to directly or indirectly engage with at least one of elongate members 110, 112, 114, tip 122, extension member 226, and combinations thereof. In one embodiment, tab 224 may define one or more features that directly or indirectly engage extension member 226. In another embodiment, tab 224 may include one or more elements that directly or indirectly engage extension member 226. For example, extension member 226 may define a corresponding opening (not shown) for directly or indirectly engaging tab 224. The corresponding openings may at least partially extend through a portion of the sidewall of the extension member 226. The corresponding openings may also extend at least partially through the sidewall of the extension member 226. The corresponding openings may be "keyed" to the tabs 224 such that the tabs 224 each fit within a corresponding opening configured to receive the tabs 224. In some embodiments, the tabs 224 may be at least partially removably positioned within the corresponding openings of the extension member 226. In some instances, the tabs 224 may be fixedly attached to the extension member 226 in a permanent or semi-permanent configuration.

[0067] In some instances, engagement member 222 may define a geometric shape or may include an element including a feature having a first portion that is narrower (or smaller) in size (e.g., diameter) than a second portion. For example, tab 224 may be larger in width / diameter (e.g., transverse to the longitudinal axis) than tab arm 223. Thus, tab 224 may engage with a "keyed" opening to semi-permanently or permanently limit movement of recanalization device 108 relative to extension member 226 (or an alternative component).

[0068] In one embodiment, as illustrated in the figures (e.g., FIG. 5B), each of the tabs 224 can define a curved surface proximate the longitudinal axis (L). The curved surfaces of the tabs 224A and 224B can each be positioned at least partially within a corresponding opening in the extension member 226. The corresponding opening in the extension member 226 can prevent (or limit) longitudinal movement, lateral movement, outward movement of the engagement member 222, inward movement of the engagement member 222, and combinations thereof.

[0069] In another embodiment, each of the tabs 224 can include one or more elements configured to at least partially engage with a corresponding opening in the extension member 226. The corresponding opening in the extension member 226 can prevent (or limit) longitudinal movement, lateral movement, outward movement, inward movement, and combinations thereof. The one or more elements can extend generally perpendicular to the direction of the longitudinal axis, parallel to the longitudinal axis, angled relative to the longitudinal axis, and combinations thereof.

[0070] However, it should be understood that tab 224 may define or include other (or additional) geometric shapes or elements configured to engage with corresponding openings in extension member 226, elongate members 110, 112, 114, tip 122, and combinations thereof. Accordingly, corresponding openings may be configured to engage with corresponding tabs 224. For example, tabs 224 and corresponding openings may be "keyed," as described above. The "keyed" openings and corresponding tabs 224 may each define a shape or combination of shapes selected from a group including, but not limited to, a circle, a triangle, a square, a star, a cross, a T-shape, an oval, a rectangle, a pentagon, a diamond, a trapezoid, a hexagon, an octagon, and an ellipse. Tabs 224 and "keyed" openings may each define similar or different shapes.

[0071] However, although some embodiments are discussed with reference to extension member 226, it should also be understood that other components of system 100 (e.g., elongate members 110, 112, 114, tip 122) may be substituted for extension member 226 so long as their use does not conflict with the function or design of system 100. Additionally, while engagement member 222 is illustrated near the distal end 109A of recanalization device 108, it should be understood that a similar engagement member 222 may also be positioned near the proximal end 109B of recanalization device 108. In some examples, engagement member 222 may be positioned on the distal end 109A of recanalization device 108 and on the proximal end 109B of recanalization device 108. Additionally, engagement members 222 located on either end 109A, 109B of recanalization device 108 may be of different shapes, sizes, and locations, as described herein.

[0072] The recanalization device 108 may be removable or partially removable from the system 100. The engagement member 222 may be removable or partially removable from corresponding openings in the extension member 226, the elongate members 110, 112, 114, the tip 122, and combinations thereof. The recanalization device 108 may be removed or partially removed for cleaning, removal of extracted bodily material, and / or replacement with a recanalization device 108 of a similar or different size / shape.

[0073] In another embodiment, the system 100 may further include a band 228. The band 228 may be configured to semi-permanently or permanently restrict movement of the recanalization device 108 in one or more directions, directly or indirectly with the engaging member 222. For example, the band 228 may restrict longitudinal movement, lateral movement, outward movement of the engaging member 222, inward movement of the engaging member 222, and combinations thereof. The band 228 may define and / or include features and / or elements that restrict movement of the recanalization device 108 in one or more directions. In a non-exhaustive list, the band 228 may be directly or indirectly constrained with the engaging member 222 through the use of adhesives, welding, fasteners, crimping, a press fit, and combinations thereof.

[0074] As shown in FIGS. 5A-7B, the band 228 may directly or indirectly engage the tab 224 of the engagement member 222 to semi-permanently or permanently restrict movement of the recanalization device 108 in one or more directions. In a non-exhaustive list, the band 228 may be directly or indirectly constrained at the tab 224 by using adhesives, welding, fasteners, crimping, press-fitting, and combinations thereof. The band 228 may be at least semi-rigid to semi-permanently or permanently restrict movement of the recanalization device 108 in one or more directions. The band 228 may be one continuous piece that may slide (longitudinally) over the tab 224. The band 228 may be a non-continuous single piece that may be at least partially clamped (closed) around the tab 224. The band 228 may be two or more pieces that may at least partially engage around the tab 224 (e.g., in a clamshell configuration). The band 228 may be coaxial with the elongate members 110 , 112 , 114 and / or the extension member 226 .

[0075] In the illustrated embodiment, the recanalization device 108 is configured as a diamond cell stent pattern. In other embodiments, the recanalization device 108 may be configured differently, as further described herein, particularly with respect to Figures 12-13.

[0076] 8A shows the edge modification 214 of the diamond-shaped cell strut 210 relative to the first edge 301A of the diamond-shaped cell strut 210, and FIG. 8B shows the edge modification 214 relative to the second edge 301B of the diamond-shaped cell strut 210. The edge modification 214 allows for a reduction in the thickness of a portion of the diamond-shaped cell strut 210 (e.g., the sharp edge 306), which may make the diamond-shaped cell strut 210 more effective at grasping and / or cutting clot material contained in a patient's vasculature. In some embodiments, the edge modification 214 is located along the inner diameter 301A of the tooth 212, the outer diameter 301B of the tooth 212, or both the inner diameter 301A and the outer diameter 301B of the tooth 212 (see FIGS. 4 and 5A). In some embodiments, a tooth 212 may have an edge modification 214 added to a first edge 301A of the tooth 212, and an adjacent tooth 212 may have an edge modification 214 added to a second edge 301B. In other embodiments, the teeth 212 may all have the same edge modification 214, or the teeth 212 may have any other configuration of edge modifications 214.

[0077] The edge modification 214 in FIGS. 8A and 8B are substantially similar, except that in FIG. 8A , the sharp edge 306 of the edge modification 214 abuts the first edge 301A. Conversely, in FIG. 8B , the sharp edge 306 of the edge modification 214 abuts the second edge 301B. Depending on the location of the edge modification 214 (e.g., whether it abuts the first edge 301A or the second edge 301B), the sharp edge 306 may be proximate the first edge 301A or the second edge 301B of the diamond-shaped cell strut 210, or in some embodiments, the sharp edge 306 may be within the thickness of the diamond-shaped cell strut 210. The edge modification 214 may be formed via off-axis laser cutting or post-processing. Additionally, multiple types of edge modifications 214 (e.g., inner diameter 301A, second edge 301B, or the entire thickness of the diamond-shaped cell strut) may be included in the same diamond-shaped cell strut 210 and / or the same recanalization device 108 (shown in Figures 4-6).

[0078] 9A and 9B respectively illustrate a first position 402 (e.g., a radially expanded position relative to the longitudinal axis (L) of the recanalization device 108 shown in FIGS. 1A-3D ) and a second position 404 (e.g., a radially compressed position relative to the longitudinal axis L of the recanalization device 108 shown in FIGS. 1A-3D ) of the recanalization device 108, compared to the first position. In the first position 402, the recanalization device 108 has a first diameter D1 and a first length X1. In the second position 404, the recanalization device 108 has a second diameter D2 that is smaller than the first diameter D1 and a second length X2 that is larger than the first length X1. Diameters D1, D2 are measured i) from the outermost first portion 406 of the diamond-shaped cell struts 210, which is radially farthest from the inner elongate member 110 of the recanalization device 108, to ii) the outermost second portion 408 of the diamond-shaped cell struts 210, which is radially farthest from the inner elongate member 110, in the opposite direction from the outermost first portion 406 of the recanalization device 108. Lengths X1, X2 are measured from the distal portion 109A to the proximal portion 109B of the recanalization device 108. In both the first and second positions 402, 404, the recanalization device 108 has advanced distally from the outer elongate member 114 shown in FIG. 1A (e.g., beyond the distal end portion 115A, shown in FIG. 1A , of the outer elongate member 114).

[0079] To move the recanalization device 108 to the first position 402, the user can rotate the actuator 136 (as shown in FIGS. 1A-3D ) to drive the lead screw 140 either distally or proximally to a desired size (e.g., diameter to length ratio) of the recanalization device 108, as illustrated by the indicator scale 138. For example, moving the lead screw 140 distally drives the middle elongate member 112 distally on the inner elongate member 110, thereby driving the proximal portion 109B of the recanalization device 108 distally toward the distal portion 109A, radially expanding the recanalization device 108 while shortening the recanalization device 108. Proximal movement of the lead screw 140 drives the intermediate elongated member 112 proximally past the inner elongated member 110 (which remains stationary or nearly stationary), thereby driving the proximal portion 109B of the recanalization device 108 proximally away from the distal portion 109A, radially compressing the recanalization device 108 while increasing the length of the recanalization device 108.

[0080] 1A-3D , the indicator scale 138 of the handle 106 is configured to provide a visual indication of the degree of radial expansion of the recanalization device 108 in the first position 402. However, the indicator scale 138 may also indicate when the recanalization device 108 is in the second position 404, or any other position. In the illustrated embodiment, the indicator scale 138 includes an opening for viewing an indicator 139 of the lead screw 140. The indicator scale 138 may include a scale indicating the relative size of the recanalization device 108. In other embodiments, the indicator scale 138 may be any suitable indicator. Additionally, although the actuator 136 and the lead screw 140 are described herein as moving the recanalization device 108 to the first position 402, it should be understood that any suitable mechanism may be used to adjust the position of the recanalization device 108.

[0081] To move recanalization device 108 to second position 404, a user can compress trigger mechanism 124, extending inner elongate member 110 distally until recanalization device 108 achieves a desired size (e.g., diameter to length ratio). Specifically, a user can compress gripping portion 126 of trigger mechanism 124, which translates adapter 142 via linkage 128. During compression of gripping portion 126, a user compresses biasing member 127, which is attached to a distal portion of adapter 142, to longitudinally translate adapter 142. As described above, the inner elongate member 110 is constrained by the adapter 142, so that when the adapter 142 moves distally, the inner elongate member 110 also moves distally, thereby driving the distal portion 109A of the recanalization device 108 distally away from the proximal portion 109B, radially compressing the recanalization device 108 and extending the recanalization device 108. Because distal movement of the adapter 142 (and inner elongate member 110) must overcome the biasing member 127, the user can compress the recanalization device 108 any amount, and the recanalization device 108 will maintain its size, referred to as the second position 404. Fully releasing the gripping portion 126 returns the recanalization device 108 to the first position 402. In some embodiments, the proximal portion of the lead screw 140 can act as a stop for the adapter 142, ensuring that the recanalization device 108 is not compressed to the point of damaging the device 108.

[0082] Relative movement of elongate members 110, 112 lengthens and / or shortens (as shown in first position 402) the distance between distal end 109A and proximal end 109B (as shown in second position 404) of recanalization device 108, radially expanding (as shown in first position 402) and / or compressing (as shown in second position 404) recanalization device 108. Although two discrete positions 402, 404 are shown in Figures 9A and 9B, the recanalization device may be expanded to any number of consecutive positions therebetween, to positions more radially expanded than first position 402, and / or less radially expanded than second position 404.

[0083] In some embodiments, when the recanalization device 108 is positioned within the outer elongate member 114, the recanalization device 108 may be in a compressed position, in some cases a fully compressed position or a nearly fully compressed position. Upon distal movement of the recanalization device 108 from the outer elongate member 114, the recanalization device 108 may remain in the compressed position. The user may then adjust the actuator 136 to the desired first position 402, as described herein. Thus, the user has complete control over the size of the recanalization device 108 and the positions 402, 404 of the recanalization device 108.

[0084] During operation, the inner elongate member 110 may move relative to the port housing 134 but may maintain a fluid connection with the port 135. In a first position 402 of the recanalization device 108, the inner elongate member 110 may be positioned within the port housing 134 having a first length. In a second position 404 of the recanalization device 108, the inner elongate member 110 may be positioned within the port housing 134 having a second length. The second length of the inner elongate member 110 may be shorter than the first length, but the second length may be sufficient to maintain a fluid connection with the port 135.

[0085] The recanalization device 108 can be configured to deform upon engagement with an obstruction (e.g., a vein segment, clot material within a vein wall) without lengthening and / or shortening the inner elongate member 110 and / or the intermediate elongate member 112. For example, the recanalization device 108 can be configured to deform one or more struts 204 and / or diamond cell struts 210 upon engagement with an obstruction (e.g., a vein segment, clot material within a vein wall) without lengthening and / or shortening the inner elongate member 110 and / or the intermediate elongate member 112. In other words, the recanalization device 108 can be flexible to deform locally in the region that engages the obstruction, but can be rigid to remove the obstruction as needed. The flexibility of the recanalization device 108 is not sufficient to overcome the biasing member 127 and move the inner elongate member 110 relative to the intermediate elongate member 112.

[0086] FIG. 10 is a flowchart of a method 500 that a user (e.g., a physician, clinician, etc.) may implement using system 100 (shown and described with respect to FIGS. 1A-3D ). In step 510, elongate members 110, 112, 114 are advanced intravascularly to a patient's target location (e.g., a vein segment containing chronic clot material). In some instances, the target location may be a location before and / or after the vein segment containing chronic clot material. Once at the target location, in step 520, recanalization device 108 is unsheathed and then radially expanded to engage the vasculature at the target location. Next, in step 530, recanalization device 108 is moved axially (e.g., in a scrubbing or rotational motion) to debulk the chronic clot material from the target location. Once the chronic clot material has been removed from the target location, trigger mechanism 124 may be engaged to advance and / or retract elongate members 110, 112, 114 to a second position, as needed, in step 540. In the second position, the recanalization device 108 may treat the diseased vessel at step 550, as described above. In use, when a user engages resistance through external compression or the like, the trigger mechanism 124 may be engaged to temporarily reduce the diameter of the recanalization device 108 (e.g., reduce the diameter to less than the first diameter D1). The method 500 ends at step 560 with the elongate member being withdrawn from the patient.

[0087] 11 illustrates recanalization system 600. Recanalization system 600 is substantially similar to recanalization system 100, as shown and described with respect to FIGS. 1A-3D, except that recanalization system 600 includes outer elongate member 602, which has a different function than outer elongate member 114 of recanalization system 100.

[0088] Specifically, the outer elongate member 602 has a larger diameter than the outer elongate member 114 and is fitted with a system (not shown) that may be configured to enable removal of debulked clot material via suction. For example, debulked clot material may be trapped within the lumen of the outer elongate member 602 as the recanalization device 108 debulks the material. That is, the outer elongate member 602 may define an internal passageway within the lumen for debulked clot material to flow from the recanalization device 108. When the elongate members 110, 112, 602 are withdrawn and / or removed from the patient, a suction device may be attached to the side port 120 shown in FIGS. 1A-3D to remove the debulked clot from the lumen of the outer elongate member 602. In other embodiments, aspiration of the depleted clot material may occur while the elongate members 110, 112, 602 and recanalization device 108 are still within and functioning within the patient's vasculature.

[0089] 12 and 13 illustrate different embodiments of the recanalization device 108 of the recanalization system 100 as shown and described with respect to FIGS. 1A-9B and as shown and described with respect to FIGS. 1A-3D.

[0090] 12, there is shown a recanalization device 700. The recanalization device 700 is substantially similar to the recanalization device 108 shown and described with respect to FIGS. 1A-9B, except that the recanalization device 700 has a different configuration 702 of struts 704, as described below.

[0091] The recanalization device 700 extends from a proximal end 701B to a distal end 701A. The distal end 701A includes an atraumatic shape. In a central portion of the recanalization device 700 (e.g., the region between the distal end 701A and the proximal end 701B), the diamond-shaped cell struts 706 are configured to allow a retrieval bag (not shown) to be attached to the plurality of diamond-shaped cell struts 706. In some embodiments, the retrieval bag may retrieve debulked clot material as the recanalization device 700 functions within the patient's vasculature, reducing the patient's risk of a thrombotic event. The recanalization device 700 includes a floating shaft 708 configured to transmit force from the middle elongated member 112 (e.g., shown in FIG. 1A ) to the center of the recanalization device 700 and to a weld ring 710. The floating shaft 708 allows the weld ring 710 to move relative to the middle elongated member 112, which allows the recanalization device 700 to be crimped. In other embodiments, the floating shaft 708 may be coupled to either the distal portion 113A of the middle elongated member 112 or the weld ring 710. Additionally, in some embodiments, a complete ring (as shown here) may be coupled to the distal end 701A of the recanalization device 700. These features may increase the pushability of the recanalization device 700 within the patient's vasculature by transmitting force from the middle elongated member 112 to the distal end 701A of the recanalization device 700.

[0092] FIG. 13 is a perspective view of a recanalization device 1600 including a harpoon strut 1602. The harpoon strut 1602 includes a metal structure having arms 1604 with free ends positioned away from the end of the harpoon strut 1602 secured to the distal end of the recanalization device 1600. The free ends are positioned proximal to the proximal end of the recanalization device 1600. In use, the harpoon strut 1602 is positioned within the clot material and rotates about axis A to apply tension to the clot. Meanwhile, a second device (not shown) including a wall-mounted device may be advanced or retracted over the harpoon strut 1602 to remove the clot material from the vessel wall. This use may mimic endarterectomy, where tension is applied to clot material prior to severing it. Similarly, the harpoon strut 1602 is configured to apply tension prior to radially severing the clot from the vessel wall using another device. Additionally, the recanalization device 1600 and harpoon struts 1602 may be used to sever adherent clots similar to an inverted bulboroid. That is, the recanalization device 1600 may be deployed through the clot and retracted through the lesion. The free end of the recanalization device 1600 may be shaped to be atraumatic to the vessel wall and to limit engagement attachment. As the device 1600 is retracted, the arms 1604 may engage the clot, and as the clot moves toward the distal end of the recanalization device 1600, the arms 1604 may engage a sharp edge at the base of the arms 1604.

[0093] The following sections further define certain aspects and embodiments of the present disclosure.

[0094] Item 1. A recanalization system including a handle located at a proximal end of the system, a first elongated member, and a second elongated member. The first and second elongated members are movable relative to each other, and a recanalization device is located at a distal end of the system. The recanalization device includes a first end portion coupled to the first elongated member, a second end portion coupled to the second elongated member, and at least one strut extending between the first and second end portions. The recanalization device is configured to (i) selectively expand and compress radially and (ii) move axially relative to the first and second elongated members.

[0095] Item 2. The recanalization system described in Item 1, wherein the axial movement of the recanalization device is at least one of (i) axial back and forth movement or scrubbing, and (ii) rotation.

[0096] Item 3. The recanalization system of any preceding item, wherein the first and second elongate members are catheters, the catheters are hypotubes, and the hypotubes are formed of nitinol.

[0097] Item 4. The recanalization system of any preceding item 1, wherein the recanalization device further comprises a third elongated member, the first and second elongated members being contained within an inner lumen of the third elongated member, and the first and second elongated members being movable relative to the third elongated member.

[0098] Item 5. The recanalization system of item 4, wherein the third elongate member is an aspiration catheter, a delivery catheter, or a guide catheter, and the third elongate member comprises a braided or coil reflow structure.

[0099] Item 6. The recanalization system of any preceding item, wherein the handle includes an actuator, an indicator scale, and a lead screw rotatably coupled to the actuator, the actuator and lead screw configured to move the second elongated member relative to the first elongated member.

[0100] Item 7. The recanalization system of any preceding item, wherein the proximal end of the second elongated member is coupled to a lead screw, and the lead screw is actuated by an actuator.

[0101] Item 8. The recanalization system of any preceding item, wherein the lead screw defines an indicator configured to move relative to an indicator scale on the handle to visually indicate the degree of radial expansion of the at least one strut of the recanalization device.

[0102] Item 9. The recanalization system of any preceding item, wherein the handle further includes a trigger mechanism coupled to the first elongate member, the trigger mechanism configured to, upon actuation, advance the recanalization device from the first position to the second position, thereby radially contracting the recanalization device from the expanded configuration.

[0103] Item 10. The recanalization system of item 9, wherein, when released, a biasing member coupled to the trigger mechanism is configured to return the first elongated member to the first position, thereby expanding the recanalization device to the expanded configuration.

[0104] Item 11. The recanalization system of any of the preceding items, wherein the recanalization device is a stent.

[0105] Item 12. The recanalization system of any preceding item, wherein the recanalization device further includes a third portion extending between the first end portion and the second end portion.

[0106] Item 13. The recanalization system described in Item 12, wherein at least one strut of the recanalization device includes a plurality of pairs of support struts, a first subset of a plurality extending from the first end portion toward the third portion, and a second subset of a plurality extending from the second end portion toward the third portion.

[0107] Item 14. The recanalization system of item 13, wherein the plurality of pairs of support struts includes six pairs of support struts, a first subset includes three pairs of support struts, and a second subset includes three pairs of support struts.

[0108] Item 15. The recanalization system according to any one of items 12 to 14, wherein at least one strut of the recanalization device further comprises a plurality of diamond-shaped cell struts extending between the support struts in a third portion of the recanalization device.

[0109] Item 16. The recanalization system according to Item 15, wherein the plurality of diamond-shaped cell struts includes six diamond-shaped cell struts.

[0110] Item 17. The recanalization system according to any one of items 15 to 16, wherein each pair of support struts is connected to a single joint that connects to the apex of each diamond-shaped cell strut.

[0111] Item 18. The recanalization system according to any one of items 15 to 17, wherein each of the diamond-shaped cell struts includes a plurality of teeth along the length of the diamond-shaped cell strut, and each of the diamond-shaped cell struts includes two edges.

[0112] Item 19. The recanalization system according to item 18, wherein the teeth are sized and shaped as at least one of a trapezoid, a triangle, and a semicircle.

[0113] Item 20. The recanalization system according to any one of items 18 to 19, wherein the edge of each diamond-shaped cell strut at least partially includes an edge modification, the edge modification including a reduction in edge thickness terminating in a sharp edge.

[0114] Item 21. The recanalization system of any preceding item, wherein a retrieval bag is contained within the recanalization device and extends from the first end portion to the second end portion.

[0115] Item 22. The recanalization system of any preceding item, wherein the first and second elongate members are contained within the suction device and are movable relative to the suction device.

[0116] Item 23. The recanalization system of any preceding item, wherein the recanalization device further includes two opposing tabs extending outward from the first end portion or the second end portion of the recanalization device, the two opposing tabs configured to be biased inward toward each other, and the two opposing tabs configured to directly or indirectly engage at least one of the first elongate member or the second elongate member.

[0117] Item 24. The recanalization system according to Item 23, further comprising a band configured to engage with the two opposing tabs of the recanalization device, the band configured to limit movement of the two opposing tabs of the recanalization device.

[0118] Item 25. A method for recanalization, comprising: (i) advancing multiple elongated members of a recanalization system within a blood vessel to a target location in a patient; (ii) radially expanding a recanalization device of the recanalization system to engage the target location; (iii) axially moving the recanalization device to debulk clot material at the target location; and (iv) withdrawing the multiple elongated members of the recanalization system from the patient.

[0119] Item 26. The method of item 25, further comprising: (i) engaging a trigger mechanism of the recanalization system to advance or retract the plurality of elongated members to a second position; and (ii) debulking the clot material from the second position.

[0120] Item 27. A recanalization device including: first and second ends and a center between the first and second ends, the first and second ends spaced apart along an axis, the first and second ends movable toward and away from the center of the recanalization device; at least one strut member extending away from each of the first and second ends and terminating in an apex member; a diamond-shaped cell strut extending between and integral with the two apex members, the strut including opposed outwardly facing edges; and a number of teeth located along each edge.

[0121] Item 28. The recanalization device of item 27, wherein the diamond-shaped cell strut members include a plurality of teeth along each of the opposing edges.

[0122] Item 29. The recanalization device according to item 28, wherein the plurality of teeth along one edge are spaced apart and each tooth along a second edge is laterally aligned with a space separating adjacent teeth along one edge.

[0123] Item 30. The recanalization device of any of items 27-29, wherein the diamond-shaped cell strut member includes three teeth along one edge and two teeth along the opposite edge.

[0124] Item 31. The recanalization device according to any one of items 27 to 30, wherein the recanalization device includes a plurality of strut members extending away from each of the first and second ends.

[0125] Item 32. The recanalization device of item 31, wherein the recanalization device includes six strut members extending away from each of the first and second ends.

[0126] Item 33. The recanalization device according to any one of items 27 to 32, wherein the recanalization device includes three pairs of strut members extending from each of the first and second ends, each pair of struts terminating in an apex member.

[0127] Item 34. The recanalization device according to any one of items 27 to 33, wherein the teeth terminate in cutting edges.

[0128] Item 35. The recanalization device according to any one of Items 27 to 34, wherein each of the teeth has a trapezoidal adjustment surface.

[0129] Item 36. The recanalization device described in any one of items 27 to 35, wherein each of the diamond-shaped cell strut members has a high point located at a greater distance from the recanalization device axis where the diamond-shaped cell strut terminates integrally with the apex member.

[0130] Item 37. The recanalization device according to any one of Items 27 to 36, further comprising two opposing tabs extending outward from the first end portion or the second end portion, the two opposing tabs being configured to be biased inward toward each other.

[0131] The above detailed description of embodiments of the present disclosure is not intended to be exhaustive or to limit the disclosure to the precise form disclosed above. Specific embodiments and examples of the present disclosure have been described above for illustrative purposes, but various equivalent modifications are possible within the scope of the present disclosure, as those skilled in the relevant art will recognize. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0132] From the foregoing, it will be understood that, although specific embodiments of the present disclosure have been described herein for illustrative purposes, well-known structures and functions have not been shown or described in detail in order to avoid unnecessarily obscuring the description of the embodiments of the present disclosure. Where the context allows, singular or plural terms may also include plural or singular terms, respectively.

[0133] Furthermore, unless the term "or" in connection with a list of two or more items is limited to referring to only a single item exclusively from the other items, the use of "or" in such a list should be interpreted to include (i) any single item in the list, (ii) all items in the list, or (iii) any combination of items in the list. Furthermore, the terms "comprise" and "comprising" are used throughout to mean the inclusion of at least the recited features, and thereby not the exclusion of any greater number of the same and / or other features. While specific embodiments have been described herein for illustrative purposes, it will be understood that various modifications can be made without departing from the disclosure. Furthermore, while advantages associated with some embodiments of the present disclosure have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily exhibit such advantages, to fall within the scope of the present disclosure. Thus, the present disclosure may encompass other embodiments not expressly shown or described herein.

Claims

1. A recanalization system, a handle located at a proximal end of the system; a first elongated member; a second elongated member, wherein the first and second elongated members are movable relative to each other; and a recanalization device located at a distal end of the system, a first end portion connected to the first elongate member; a second end portion connected to the second elongate member; at least one strut extending between the first end portion and the second end portion; The recanalization device is configured to (i) be selectively radially expanded and compressed, and (ii) be axially moved relative to the first and second elongate members.

2. The recanalization system of claim 1 , wherein the axial movement of the recanalization device is at least one of (i) an axial back-and-forth movement or scrubbing, and (ii) a rotation.

3. The recanalization system of claim 1 , wherein the first and second elongate members are catheters, the catheters are hypotubes, and the hypotubes are formed of nitinol.

4. 2. The recanalization system of claim 1, wherein the recanalization device further comprises a third elongated member, the first and second elongated members being contained within a lumen within the third elongated member, and the first and second elongated members being movable relative to the third elongated member.

5. The recanalization system of claim 4 , wherein the third elongate member is an aspiration catheter, a delivery catheter, or a guide catheter, and the third elongate member comprises a braided or coiled reflow structure.

6. 2. The recanalization system of claim 1, wherein the handle includes an actuator, an indicator scale, and a lead screw rotatably coupled to the actuator, the actuator and the lead screw configured to move the second elongated member relative to the first elongated member.

7. The recanalization system of claim 6 , wherein a proximal end of the second elongate member is coupled to the lead screw, the lead screw being actuated by the actuator.

8. The recanalization system of claim 7 , wherein the lead screw defines an indicator configured to move relative to the display scale to visually indicate the degree of radial expansion of the at least one strut of the recanalization device.

9. 2. The recanalization system of claim 1, wherein the handle further comprises a trigger mechanism coupled to the first elongate member, the trigger mechanism configured to, when actuated, advance the recanalization device from a first position to a second position, thereby radially contracting the recanalization device from an expanded configuration.

10. The recanalization system of claim 9 , wherein, when released, a biasing member coupled to the trigger mechanism is configured to return the first elongated member to the first position, thereby expanding the recanalization device to the expanded configuration.

11. The recanalization system of claim 1 , wherein the recanalization device is a stent.

12. The recanalization system of claim 1 , wherein the recanalization device further comprises a third portion extending between the first end portion and the second end portion.

13. 13. The recanalization system of claim 12, wherein the at least one strut of the recanalization device comprises a plurality of pairs of support struts, a first subset of the plurality extending from the first end portion toward the third portion, and a second subset of the plurality extending from the second end portion toward the third portion.

14. The recanalization system of claim 13 , wherein the plurality of pairs of support struts includes six pairs of support struts, the first subset includes three pairs of support struts, and the second subset includes three pairs of support struts.

15. The recanalization system of claim 14 , wherein the at least one strut of the recanalization device further comprises a plurality of diamond-shaped cell struts extending between the support struts at the third portion of the recanalization device.

16. The recanalization system of claim 15 , wherein the plurality of diamond-shaped cell struts comprises six diamond-shaped cell struts.

17. 17. The recanalization system of claim 16, wherein each pair of support struts is connected to a single joint that connects to the apex of each diamond-shaped cell strut.

18. The recanalization system of claim 15, wherein each of the diamond-shaped cell struts includes a plurality of teeth along the length of the diamond-shaped cell strut, and each of the diamond-shaped cell struts includes two edges.

19. The recanalization system of claim 18 , wherein the teeth are sized and shaped as at least one of a trapezoid, a triangle, and a semicircle.

20. 20. The recanalization system of claim 18, wherein the edge of each diamond-shaped cell strut at least partially includes an edge modification, the edge modification including a reduction in thickness of the edge terminating in a sharp edge.

21. The recanalization system of claim 1 , wherein a retrieval bag is contained within the recanalization device and extends from the first end portion to the second end portion.

22. The recanalization system of claim 1 , wherein the first and second elongate members are contained within a suction device and are movable relative to the suction device.

23. 2. The recanalization system of claim 1, wherein the recanalization device further comprises two opposing tabs extending outward from the first end portion or the second end portion of the recanalization device, the two opposing tabs configured to be biased inward toward each other, and the two opposing tabs configured to directly or indirectly engage with at least one of the first elongated member or the second elongated member.

24. 24. The recanalization system of claim 23, further comprising a band configured to engage the two opposing tabs of the recanalization device, the band configured to limit movement of the two opposing tabs of the recanalization device.

25. 1. A method for recanalization, comprising: advancing a plurality of elongate members of the recanalization system intravascularly to a target location within the patient; radially expanding a recanalization device of the recanalization system to engage the target location; axially moving the recanalization device to debulk clot material at the target location; and withdrawing the plurality of elongate members of the recanalization system from the patient.

26. engaging a trigger mechanism of the recanalization system to advance or retract the plurality of elongated members to a second position; and debulking the clot material from the second location.

27. A recanalization device, a first end and a second end, and a center between the first end and the second end, the first end and the second end being spaced apart along an axis, the first end and the second end being movable toward and away from the center of the recanalization device; at least one strut member extending away from each of the first and second ends and terminating in an apex member; diamond-shaped cell struts extending between and integral with the two vertex members, each diamond-shaped cell strut comprising: With opposing outward edges, and a number of teeth located along each edge.

28. 28. The recanalization device of claim 27, wherein the diamond-shaped cell strut member includes a plurality of teeth along each of the opposing edges.

29. 29. The recanalization device of claim 28, wherein the tines along the one edge are spaced apart and each tine along the second edge is laterally aligned with a space separating adjacent tines along the one edge.

30. 30. The recanalization device of claim 29, wherein the diamond-shaped cell strut member includes three tines along one edge and two tines along an opposing edge.

31. 28. The recanalization device of claim 27, wherein the recanalization device includes a plurality of strut members extending away from each of the first and second ends.

32. 32. The recanalization device of claim 31, wherein the recanalization device includes six strut members extending away from each of the first and second ends.

33. 31. The recanalization device of claim 30, wherein the recanalization device includes three pairs of strut members extending from each of the first and second ends, each pair of struts terminating in an apex member.

34. The recanalization device of claim 30, wherein the teeth terminate in cutting edges.

35. 35. The recanalization device of claim 34, wherein each of the teeth has a trapezoidal shaped alignment surface.

36. 28. The recanalization device of claim 27, wherein each of the diamond-shaped cell strut members has a high point located a greater distance from the recanalization device axis where the diamond-shaped cell strut terminates integrally with the apex member.

37. 28. The recanalization device of claim 27, further comprising two opposing tabs extending outwardly from the first end portion or the second end portion, the two opposing tabs configured to be biased inwardly toward each other.

Images