Re-pass devices and associated systems and methods

Abstract

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

Description

[0001] Cross - reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 375,682, filed on September 14, 2022, the disclosure of which is hereby incorporated by reference in its entirety. Technical field

[0003] The field of the present disclosure generally relates to recanalization devices, and more particularly, to recanalization devices configured to recanalize occluded vascular segments, particularly chronically occluded vascular segments. Background art

[0004] 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 persistent pain, edema, and other symptoms caused by clot material that remains in the patient's vasculature. Additionally, the longer the clot material remains in the patient's vasculature, the more it hardens, making it difficult for treatments and devices to remove the clot material. This hardening can further exacerbate the symptoms of PTS. Thus, current treatments for chronically occluded vasculature include symptom management, endarterectomy, or complete vein excision (invasive procedures).

[0005] 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 referred to as the "‘852 patent") and 11,406,418 (hereinafter referred to as the "‘418 patent") describe current thrombectomy devices. The thrombectomy device includes a self - adjusting cage in which a resistance mechanism is adjusted without any user input other than the user's action of moving the device along the blood vessel. Thus, the diameter of the self - adjusting cage depends on the diameter of the blood vessel.

[0006] Based on the foregoing, there is a need for a recanalization system that provides enhanced control to the user over the expansion and contraction of a recanalization device. Summary of the invention

[0007] In one aspect, a recanalization system is provided that includes: a handle located at a proximal end of the system; a first elongate member; a second elongate member; and a recanalization device located at a distal end of the system. The handle includes an actuator. The first elongate member is movable relative to the second elongate member. The recanalization device includes: a first end portion coupled to the first elongate member; a second end portion coupled to the second elongate member; and at least one strut extending between the first end portion and the second end portion. 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 elongate member and the second elongate member.

[0008] In another aspect, a method for recanalization is provided. The method includes: (i) advancing a plurality of elongate members of a recanalization system into a target location within a patient's body within a blood vessel; (ii) radially expanding a recanalization device of the recanalization system to engage the target location; (iii) axially moving the recanalization device to clear clot material at the target location; and (iv) withdrawing the plurality of elongate members of the recanalization system from the patient's body.

[0009] In yet another aspect, a recanalization device is provided. The recanalization device includes: (i) a first end and a second end, and a center therebetween, 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; (ii) at least one strut member extending away from each of the first end and the second end and terminating at a vertex member; and (iii) a diamond cell strut extending between and integral with the two vertex members. Each diamond cell strut includes: (i) opposing outwardly directed edges; and (ii) a plurality of teeth positioned along each edge.

[0010] There are various improvements to the features noted in the above aspects. Other features may also be incorporated into the above aspects. These improvements and additional features may exist alone or in any combination. For example, the various features discussed below with respect to any illustrative embodiment may be incorporated alone or in any combination into any of the above aspects.

[0011] As used herein, unless the context clearly dictates otherwise, "a / an" and "the" refer to both singular and plural referents.

[0012] As used herein, unless clearly indicated to refer to alternatives only or to mutually exclusive alternatives, the term "or" (including in the claims) is used to mean "and / or".

[0013] As used herein, the term "about" refers to a measurable value, such as a parameter, quantity, duration, etc., and means including variations of + / - 15% or less, preferably + / - 10% or less, more preferably + / - 5% or less, even more preferably + / - 1% or less, and still more preferably + / - 0.1% or less of a particular recited value, so long as such variations are suitable for implementation in the invention described herein. In addition, it should be understood that the value itself to which the modifier "about" refers is specifically disclosed herein.

[0014] As used herein, for ease of description, spatial relative terms, such as "below", "beneath", "lower", "above", "upper", "front", "rear", "side", "left", "right", "back", etc., are used to describe the relationship of one element or feature to another element or feature. It should also be understood that the terms "front", "rear", "left", and "right" are not intended to be limiting and are intended to be interchangeable where appropriate. In addition, it should be noted that the terms "first", "second", etc. in this document do not denote any order, quantity, or relative importance, but are used to distinguish one element from another.

[0015] As used herein, the terms "comprise(s) / comprising", etc. specify the presence of the 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.

[0016] As used herein, the terms "configure(s) / configuring", etc. refer to the capabilities of a part and / or component, but do not preclude the presence or addition of other capabilities, features, parts, elements, operations, and any combination thereof.

[0017] Compounds are described using standard nomenclature. For example, any position not substituted by any designated group is understood to be filled with a bond or hydrogen atom having the valence assigned to it.

[0018] All ranges disclosed herein include the endpoints, and the endpoints can be combined independently of each other. Each range disclosed herein constitutes a disclosure of any point or sub-range located within the disclosed range.

[0019] Unless otherwise stated herein or clearly contradicted by the context, all methods described herein can be performed in any suitable order. Unless otherwise required, the use of any and all examples or exemplary language (e.g., "such as") is merely intended to better illustrate the invention and does not limit the scope of the invention or any embodiment thereof.

[0020] Any combination or arrangement of the features, functions, and / or embodiments disclosed herein is contemplated. Additional advantageous features, functions, and applications of the disclosed systems, methods, and components of the present disclosure will be apparent from the following description, particularly when read in conjunction with the accompanying drawings. All references listed in this disclosure are hereby incorporated by reference in their entirety. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The features and aspects of the embodiments are described below with reference to the drawings, in which the elements are not necessarily drawn to scale. Throughout the several views of the drawings, corresponding reference numerals indicate corresponding parts.

[0022] Exemplary embodiments of the present disclosure are further described with reference to the drawings. It should be noted that the various features, steps, and combinations of features / steps described below and illustrated in the drawings may be arranged and organized differently to produce embodiments that are still within the scope of the present disclosure.

[0023] To assist one of ordinary skill in the art in making and using the disclosed components, systems, and methods, reference is made to the drawings, in which:

[0024] Figure 1A is a side perspective view of a recanalization system according to an embodiment of the present disclosure;

[0025] Figure 1B is a side cross-sectional view of a recanalization system according to an embodiment of the present disclosure Figure 1A of;

[0026] Figure 2A is a side view of a recanalization system according to an embodiment of the present disclosure;

[0027] Figure 2B is a side cross-sectional view of a recanalization system according to an embodiment of the present disclosure Figure 2A of, wherein the recanalization device is in a first position;

[0028] Figure 2C is a side cross-sectional view of a recanalization system according to an embodiment of the present disclosure Figure 2A of, wherein the recanalization device is in a second position;

[0029] Figure 2D is a side cross-sectional view of a recanalization system according to an embodiment of the present disclosure Figure 2B of the trigger of;

[0030] Figure 2E is a side cross-sectional view of a recanalization system according to an embodiment of the present disclosure Figure 2B of the lead screw of;

[0031] Figure 2F is a side cross-sectional view of a recanalization system according to an embodiment of the present disclosure Figure 2B of the biasing member of;

[0032] Figure 3A is a perspective view of a recanalization system according to an embodiment of the present disclosure;

[0033] Figure 3B is according to an embodiment of the present disclosure Figure 3A an enlarged perspective view of the recanalization system;

[0034] Figure 3C is according to an embodiment of the present disclosure Figure 3A a perspective sectional view of the recanalization system;

[0035] Figure 3D is according to an embodiment of the present disclosure Figure 3C a detailed view of a biasing member of the recanalization system;

[0036] Figure 4 is according to an embodiment of the present disclosure Figures 1A to 3D a side perspective view of a recanalization device of the recanalization system;

[0037] Figure 5A is according to an embodiment of the present disclosure Figures 1A to 3D a side perspective view of a recanalization device of the recanalization system;

[0038] Figure 5B is according to an embodiment of the present disclosure Figure 5A a partially enlarged sectional view of the recanalization device;

[0039] Figure 6 is according to an embodiment of the present disclosure Figure 5A a partially enlarged perspective view of the recanalization device;

[0040] Figure 7A is according to an embodiment of the present disclosure Figure 5A a partially enlarged perspective view of the recanalization device;

[0041] Figure 7B is according to an embodiment of the present disclosure Figure 7A a partially enlarged sectional view of the recanalization device;

[0042] Figure 8A is according to an embodiment of the present disclosure Figures 4 to 7B a perspective view of a part of a diamond unit strut of the recanalization device;

[0043] Figure 8B is according to an embodiment of the present disclosure Figures 4 to 7B a perspective view of a part of another diamond unit strut of the recanalization device;

[0044] Figure 9A is according to an embodiment of the present disclosure in a first positionFigures 1A to 3D Side perspective view of a recanalization device of a recanalization system;

[0045] Figure 9B is of a recanalization device of a recanalization system in a second position according to an embodiment of the present disclosure; Figures 1A to 3D Side perspective view of a recanalization device of a recanalization system;

[0046] Figure 10 is a schematic diagram of an exemplary method associated with a recanalization system of Figures 1A to 3D according to an embodiment of the present disclosure;

[0047] Figure 11 is a side perspective view of an embodiment of an elongate member associated with a recanalization system of Figures 1A to 3D according to an embodiment of the present disclosure;

[0048] Figure 12 is a side perspective view of an embodiment of a recanalization device associated with a recanalization system of Figures 1A to 3D according to an embodiment of the present disclosure; Emoji

[0049] Figure 13 is a perspective view of an embodiment of a recanalization device associated with a recanalization system of Figures 1A to 3D according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0050] The present disclosure generally relates to recanalization systems and devices and associated systems and methods for recanalizing venous segments of a patient (such as a patient suffering from post-thrombotic syndrome (PTS)), for example, severely chronically occluded venous segments including iliofemoral venous segments. The recanalization systems and devices can be used by a user (such as a physician, clinician, or other trained provider) to treat an occluded venous segment of the user.

[0051] In some embodiments described herein, a recanalization system for engaging a patient's chronically occluded vasculature and removing clot material from the patient's chronically occluded vasculature 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 (e.g., a proximal portion), and at least one strut extending between the first end portion and the second end portion.

[0052] When expanded within the vasculature, a recanalization device, and more specifically, at least one strut, can translate axially and / or rotate within the vasculature (i) to engage and remove clot material. In some embodiments, at least one strut includes teeth and / or edge modification structures that are specifically configured to engage aged clot material to fragment the material without the need for a collection bag or aspiration device to remove the material from the patient.

[0053] The devices, systems, and methods described herein include technical benefits over known devices, systems, and methods. Specifically, the devices, systems, and methods described herein include at least the following technical benefits: (i) controlling the diameter defined by the struts of the recanalization device to selectively apply radial force and achieve progressive treatment, (ii) the struts of the recanalization device having higher radial force and sharp and / or serrated elements to better engage clots, (iii) at least two independent elongate members (e.g., a movable shaft or catheter) for ease of use and rapid element contraction and expansion, (iv) 360° circumferential treatment to more effectively remove clots, and (v) a dual elongate member formed of solid nitinol tubing to achieve flexibility, pushability, twistability, and kink resistance.

[0054] Certain details are set forth in the following description of Figures 1A to 13 to provide a thorough understanding of the various embodiments of the present technology. In other instances, well-known structures, materials, operations, and / or systems that are typically associated with intravascular procedures, stents, clot and occluded vein segment removal procedures, catheters, etc. are not shown or described in detail in the following disclosure to avoid unnecessarily obscuring the description of the various embodiments of the present disclosure. However, one of ordinary skill in the art will recognize that the present disclosure may be practiced without one or more of the details set forth herein and / or using other structures, methods, components, etc.

[0055] The terms used hereinafter will be interpreted in the broadest reasonable manner even if it is used in conjunction with a detailed description of certain examples of the embodiments of the present disclosure. In fact, certain terms may even be emphasized hereinafter; however, any term that is intended to be interpreted in a limiting manner will be defined explicitly and specifically in this section.

[0056] The accompanying drawings depict embodiments of the present disclosure and are not intended to limit its scope unless explicitly stated. The sizes of the various elements depicted are not necessarily drawn to scale, and these various elements may be enlarged to improve readability. When such details are unnecessary for a complete understanding of how to make and use the technology, component details may be represented in the drawings to exclude details such as component positions and certain precise connections between these components. Many of the details, dimensions, angles, and other features shown in the drawings are merely illustrative of specific embodiments of the present disclosure. Accordingly, other embodiments may have other details, dimensions, angles, and features without departing from the technology. Additionally, those of ordinary skill in the art should understand that further embodiments of the present disclosure may be practiced without several of the details described below.

[0057] Regarding the terms "distal" and "proximal" in this specification, unless otherwise stated, these terms may refer to the relative positions of the various parts of the catheter subsystem with respect to the operator and / or positions within the vasculature. Additionally, as used herein, the directional terms "backward", "forward", "upward", "downward", etc. do not imply restricting the reference component to a particular orientation. It should be understood that such directional terms refer to the orientation of the reference component shown in the accompanying drawings; the systems of the present disclosure may be used in any orientation suitable for the user.

[0058] Referring Figures 1A to 3D , in the exemplary embodiment, the system 100 extends from a proximal end 102 to a distal end 104. The proximal end 102 includes a handle 106 that is operably coupled to a recanalization device 108 located at the distal end 104 via an inner elongate member 110 (also referred to herein as the "first elongate member") and an intermediate elongate member 112 (also referred to herein as the "second elongate member"). The inner elongate member 110 may extend through the lumen of the intermediate elongate member 112 such that the inner elongate member 110 and the intermediate elongate member 112 (collectively referred to as the "elongate members 110, 112") are coaxial. The system 100 also includes an outer elongate member 114 (e.g., a suction catheter, a guiding catheter, or a delivery catheter), and the elongate members 110, 112 at least partially extend through the outer elongate member 114 such that the inner elongate member 110, the intermediate elongate member 112, and the outer elongate member 114 (collectively referred to as the "elongate members 110, 112, 114") are coaxial (or nearly coaxial) with respect to a longitudinal axis (L). In other embodiments, the elongate members 110, 112 are not coaxial and may alternatively extend side by side and / or through separate lumens of the outer elongate member 114.

[0059] In an exemplary embodiment, the elongated members 110, 112 include hypotubes and are formed of nitinol to improve the responsiveness, flexibility, kink resistance, and pushability of the system 100. In addition, in an exemplary embodiment, the outer elongated member 114 includes a braid / coil return structure with a low cross profile. In other embodiments, the elongated members 110, 112, 114 may include a catheter, a tube (e.g., a hypotube and a laser cut hypotube), a cable (e.g., a spiral hollow stranded cable), a sheath, a shaft (e.g., a torque shaft), etc., and the elongated members 110, 112, 114 may be formed of metal (e.g., stainless steel, nitinol, cobalt-chromium alloy), a braid / coil return structure, a plastic, a fluoropolymer (e.g., polytetrafluoroethylene (PTFE)), a polymer, and / or other suitable materials.

[0060] The outer elongated member 114 includes a distal portion 115A and a proximal portion 115B. The proximal portion 115B can be directly or indirectly connected to a conduit assembly 116 (e.g., including one or more tubes, fluid control devices, etc.) via a valve device 118. The valve device may include a disconnect device 148 for the outer elongated member 114. Specifically, the disconnect device 148 is configured to allow a user to quickly disconnect the outer elongated member 114 from the handle 106. In some embodiments, the conduit 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 can be moved (translatable, rotatable) relative to the valve device 118 and the outer elongated member 114.

[0061] exist Figures 1A to 3D In the illustrated embodiment of the present invention, the handle 106 has been advanced toward the valve device 118 such that the recanalization device 108 extends from the distal portion 115A of the outer elongated member 114. In some embodiments, the handle 106 can be retracted away from the outer elongated member 114, and / or the outer elongated member 114 can be advanced away from the handle 106 such that the recanalization device 108 is captured / positioned within the outer elongated member 114. When the recanalization device 108 is captured within the lumen of the outer elongated 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 elongated member 114 during delivery of the system 100 through the vasculature of a patient.

[0062] In an exemplary embodiment, system 100 includes a tip 122 located at the distal end 104 of the system 100 and is directly or indirectly coupled to the recanalization device 108 and / or the inner elongate member 110. The tip 122 can be directly or indirectly removably attached to the recanalization device 108 and / or the inner elongate member 110. In some cases, the tip 122 can be directly or indirectly semi-permanently or permanently attached to the recanalization device 108 and / or the inner elongate member 110. The tip 122 can have an atraumatic shape configured to minimize or even prevent damage to the patient's vasculature when the system 100 is advanced through the patient's vasculature (e.g., sized and shaped to be a nose cone), and the tip 122 can be formed of a polymer. In other embodiments, the tip 122 can be made of a material other than a polymer and can have a shape / configuration other than those described, or can be omitted entirely. In some embodiments, when the recanalization device 108 is constrained within the outer elongate member 114, the tip 122 can engage the distal portion 115A of the outer elongate member 114, and the shape and size can be designed to seal the lumen of the outer elongate member 114. In some embodiments, the tip 122 and the inner elongate member 110 can define a lumen 125 configured (e.g., sized and shaped) to receive a guide wire (not shown) therethrough. The system 100 can be advanced / tracked over a guide wire.

[0063] As Figure 5B shown, the tip 122 can include a proximal lumen 123 configured to directly or indirectly engage one or more of the elongate members 110, 112, 114, and / or the recanalization device 108. The tip 122 can be directly or indirectly mounted relative to the inner elongate member 110 and / or the recanalization device 108 using adhesives, welding, fasteners, crimping, press fitting, and combinations thereof. The tip 122 can define a lumen 125 configured (e.g., sized and shaped) to receive a guide wire (not shown) therethrough. The lumen 125 can longitudinally extend through at least the inner elongate member 110 and the tip 122.

[0064] The system 100 can include an extension member 226 that can be directly or indirectly coupled to at least the inner elongate member 110 and / or the tip 122. The extension member 226 can be removably attached to at least one of the inner elongate member 110 and the tip 122. In some cases, the extension member 226 can be semi-permanently (or permanently) attached to at least one of the inner elongate member 110 and the tip 122. The extension member 226 can be in direct or indirect contact with the recanalization device 108. The extension member 226 can define sidewalls formed by through holes longitudinally extending from a proximal end to a distal end.

[0065] The extension member 226 may be directly or indirectly engaged 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 circumferentially positioned around the outer surface of the extension member 226. The one or more openings may at least partially extend through the outer surface of the sidewall of the extension member 226. The recanalization device 108 may be directly or indirectly engaged with the one or more openings of the extension member 226.

[0066] In an exemplary embodiment, the recanalization device 108 includes a distal portion 109A and a proximal portion 109B, the inner elongate member 110 includes a distal portion 111A and a proximal portion 111B (e.g., see Figures 1A to 2C ), and the intermediate elongate member 112 includes a distal portion 113A and a proximal portion 113B (e.g., see Figure 1B ). The distal portion 111A of the inner elongate member 110 is coupled to the distal portion 109A of the recanalization device 108. Similarly, the distal portion 113A of the intermediate elongate member 112 is coupled to the proximal portion 109B of the recanalization device 108. Thus, as described in further detail below, particularly with respect to Figure 9A and Figure 9B , relative movement of the elongate members 110, 112 may longitudinally shorten / elongate and radially expand / compress the recanalization device 108 via relative movement of the respective distal portion 109A and proximal portion 109B of the recanalization device. The distal portion 109A and the proximal portion 109B of the recanalization device 108 may be the same and may have a cylindrical or hub-like shape. In some embodiments, the distal portion 109A and the proximal portion 109B are fixed to the elongate members 110, 112, respectively, via an adhesive (e.g., cement), welding, fasteners, crimping, etc. For example, in some embodiments, one or both of the distal portion 109A and the proximal portion 109B of the recanalization device 108 may be directly welded to the elongate members 110, 112.

[0067] As Figures 1A to 3D illustrated, the handle 106 includes a housing 130 having a distal portion 131A and a proximal portion 131B and defining an inner lumen or cavity 132. For clarity, the housing 130 is shown in Figure 1B as partially cut away and in Figures 2B to 2D as a cross-section. The proximal portions 111B, 113B of the elongate members 110, 112 extend through at least a portion of the housing 130, respectively.

[0068] In some embodiments, the handle 106 includes a port housing 134 that is operatively (e.g., fluidly) coupled to the lumen of the inner elongate member 110 and / or the intermediate elongate member 112. The port housing 134 may extend outwardly from the handle 106 and define a port 135 that is operatively (e.g., fluidly) coupled to the lumen of the inner elongate member 110 and / or the intermediate elongate member 112. The port housing 134 may define a lumen 137 that extends between a proximal portion and a distal portion of the port housing 134 and includes the port 135. The lumen 137 may be configured to engage the inner elongate member 110 either directly or indirectly. In some instances, 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 fluid into and / or deliver fluid 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 travel distance of the inner elongate member 110 during expansion / compression of the recanalization device 108.

[0069] The handle 106 includes a trigger mechanism 124 that includes a grip portion 126 and a linkage 128. As Figure 1B and Figures 2B to 2D illustrated, the linkage 128 may be directly or indirectly coupled to the inner elongate member 110. The linkage 128 may be directly or indirectly coupled to an adapter 142, and the adapter 142 may be directly or indirectly coupled to the inner elongate member 110. The adapter 142 may define a lumen 132 that extends longitudinally between a proximal end and a distal end of the adapter 142. The lumen 132 may engage the inner elongate member 110 either directly or indirectly such that the adapter 142 is coupled to the inner elongate member 110. For example, the inner elongate member 110 may include and / or define a component / feature that engages a portion of the lumen 132. As Figure 2D and Figure 2F shown, the inner elongate member 110 includes a collar 145 that is coupled to the lumen 132 such that the inner elongate member 110 and the adapter 142 translate axially in unison. In one example, 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 less 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.

[0070] The adapter 142 may also define a cavity 133 that may be axially oriented relative to the longitudinal axis (L) and the lumen 132. The cavity 133 may extend circumferentially around the lumen 132 of the adapter 142. The adapter 142 may be configured to engage the biasing member 127 directly or indirectly. The biasing member 127 may include, but is not limited to, a spring (e.g., a compression spring, a conical spring, a disc spring, a tension spring), a piston, rubber, an elastic band, and combinations thereof. In one example, the cavity 133 may be configured to engage the biasing member 127 directly or indirectly. The biasing member 127 may extend between the cavity 133 of the adapter 142 and the inner surface of the housing 130, the actuator 136, and / or the lead screw 140. For example, the biasing member 127 may extend between the cavity 133 of the adapter 142 in the direction of the distal portion 131A of the housing 130.

[0071] The adapter 142 may be directly or indirectly coupled to the outer surface of the inner elongate member 110. The linkage 128 may be configured to translate movement of the grasping 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 grasping portion 126 into axial movement of the adapter 142 along the longitudinal axis (L). When actuated by the grasping portion 126 of the trigger mechanism 124, the linkage 128 longitudinally advances the adapter 142 in the direction of 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 causes movement of the inner elongate member 110. In some cases, the inner elongate member 110 may move relative to the intermediate elongate member 112.

[0072] Reference will be made below to Figure 9A and Figure 9BThe operation of the recanalization device 108 is discussed in more detail. When actuated, movement of the trigger mechanism causes the inner elongate member 110 to be advanced such that the distal portion 111A of the inner elongate member 110 is displaced from its initial position (e.g., relative to the distal portion 113A of the intermediate elongate member 112). In one embodiment, the gripping portion 126 of the trigger mechanism 124 moves to actuate the link 128. Actuation of the link 128 thereby pushes the adapter 142 away from its fixed position and causes the adapter 142 to move axially along the longitudinal axis (L). The axial movement of the adapter 142 causes the distal portion 111A of the inner elongate member 110 to be advanced from its initial position (e.g., relative to the distal portion 113A of the intermediate elongate member 112). Since the distal portion 111A of the inner elongate member 110 is coupled to the distal portion 109A of the recanalization device 108, when the distal portion 111A of the inner elongate member 110 is advanced, the recanalization device 108 contracts from the expanded position. That is, the inner elongate member 110 is advanced while the intermediate elongate member 112 remains relatively fixed. However, it should be understood that movement of the intermediate elongate member 112 is possible and such movement 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 forces the actuator 142 and the link 128 back to the non-actuated position, thereby causing the inner elongate member 110 to be axially advanced toward the proximal end portion 102. Then, the distal portion 111A of the inner elongate member 110 returns to its initial position and the recanalization device 108 returns to the same expanded position as before the link 128 was actuated.

[0073] The trigger mechanism 124 allows the user to easily and effectively navigate within a patient's vasculature by allowing the recanalization device 108 to be easily adjusted (e.g., collapsed and returned to its initial position) between a first position and a second position. Specifically, since the recanalization device 108 can be collapsed by grasping the trigger mechanism 124 and return to its initial position once the grasp is released, the recanalization device 108 can be advanced or retracted through constricted and variable-sized regions within the patient's vasculature without the user having to manually expand the recanalization device 108 after navigation. Additionally, the controllability of the recanalization device 108 is superior to recanalization systems that are reactive when traveling through constricted regions. In other words, recanalization systems that cannot be adjusted by the user rely solely on their ability to deform to travel through constricted regions. At least one benefit of using the controllable recanalization device 108 is that the recanalization device 108 is less likely to damage the vasculature when the device travels through a constricted region within a blood vessel. Additionally, the systems described herein enable the user to control the diameter of the recanalization device 108 and advance / retract the recanalization device 108 while in a collapsed state. Yet another potential benefit is that after the recanalization device 108 is collapsed, the user may not need angiography to determine its diameter. Yet another potential benefit is that the user can actuate the recanalization device 108 to grasp / engage an obstruction on the blood vessel wall to release the obstruction from the wall.

[0074] Although the trigger mechanism 124 of the illustrated embodiment includes a linkage 128, a grasping portion, and an actuator 142, other mechanisms may be utilized to advance and retract the inner elongate member 110, as described herein. In other embodiments, the trigger mechanism 124 can be a shift knob, a button, a pull pin, and / or other motion-actuating mechanisms. Additionally, in other embodiments, the trigger mechanism 126 can be coupled to the proximal portion 113B of the intermediate elongate member 112 rather than the proximal portion 111B of the inner elongate member 110.

[0075] As Figure 2D and Figure 2E shown, the recanalization system 100 can also effect diameter adjustment of the recanalization device 108. The handle 106 also includes an actuator 136, an indicator scale 138 that indicates the relative amount of expansion of the recanalization device 108 (as further described 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 can have a threaded outer surface that is configured to mate or engage with the threaded inner surface of the actuator 136. The actuator 136 extends out of the housing 130 through one or more openings 131 (e.g., a pair of openings 131 on opposite sides of the housing 130) in the housing 130 such that the actuator 136 can be accessed by the user outside of the housing 130. The actuator 136 is configured to threadedly engage the lead screw 140 throughout its range of movement to expand / contract the recanalization device 108. In the illustrated embodiment, the actuator 136 is a rotatable knob.

[0076] In some embodiments, the lead screw 140 defines an indicator (e.g., a prominent feature) 139 that may extend outwardly and be positioned relative to an indicating scale 138. The indicator 139 may extend outwardly from the lead screw 140 in a direction perpendicular to the longitudinal axis (L). In some cases, the indicator 139 may extend outwardly and circumferentially (or semi - circumferentially) around the lead screw 140. In other cases, the indicator 139 may be mounted directly or indirectly relative to the lead screw 140. In operation, when the lead screw 140 is axially advanced in a distal or proximal direction along the longitudinal axis (L), the indicator 139 may axially move in a direction corresponding to the lead screw 140. The indicator 139 may be associated with the indicating scale 138 to indicate the relative amount of expansion of the recanalization device 108. The indicating scale 138 may include features / elements depicting the expansion of the recanalization device 108 in a scaled format, e.g., using alphanumeric characters, symbols, and combinations thereof. The features / elements may be positioned such that the indicator 139 is positioned at a point along the indicating scale 138 that corresponds to the relative expansion of the recanalization device 108.

[0077] Rotation of the actuator 136 relative to the housing 130 (e.g., by a user) may drive the lead screw 140 to translate proximally and / or distally (e.g., between the distal portion 131A and the proximal portion 131B of the housing 130), thereby driving the coupled intermediate elongate member 112 to translate relative to the inner elongate member 110. This relative movement of the elongate members 110, 112 increases / decreases the length of the recanalization device 108 to radially contract / expand the recanalization device 108, as described in further 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 relative to the housing 130 (e.g., to allow minimal movement) in place, and the distal end 109A of the recanalization device 108 may move in the direction of the proximal end 109B such that the distance between the distal end 109A and the proximal end 109B of the recanalization device 108 decreases from X1 to X2, as shown respectively in Figure 9A and Figure 9B shown. During radial contraction of the recanalization device 108, the proximal end 109B of the recanalization device 108 may be fixed or nearly fixed relative to the housing 130 (e.g., to allow minimal movement) in place, and the distal end 109A of the recanalization device 108 may move in a direction away from the proximal end 109B such that the distance between the distal end 109A and the proximal end 109B of the recanalization device 108 increases from X2 to X1, as shown respectively in Figure 9B and Figure 9A shown. The degree of collapse and expansion of the recanalization device 108 may be monitored using the display provided by the indicating scale 138 for observation by the user (asFigure 1A and Figure 3B as shown).

[0078] In some embodiments, the recanalization system 100 may include a seal cap 156. The seal cap 156 may be mounted directly or indirectly relative to the indicator 139 of the lead screw 140. Thus, the seal cap 156 may be located distally of the lead screw 140. In some embodiments, the handle 106 may include a flush port, an opening, a lumen, etc. In the illustrated embodiment, the handle 106 includes a flush port 146 for the intermediate elongate member 112. The flush port 146 may be in fluid communication with at least the seal cap 156. The flush port 146 may be in fluid communication with at least one aperture 158 of the seal cap 156 and the intermediate elongate member 112. The flush port 146 may be configured to remove air from the intermediate elongate member 112 through at least one aperture 158 and the seal cap 156.

[0079] The intermediate elongate member 112 may further define at least one aperture 158 extending through the intermediate elongate member 112 (as Figure 2D and Figure 2E shown). For example, at least one aperture 158 extends through the outer wall of the intermediate elongate member 112. In some cases, the intermediate elongate member 112 may include a plurality of apertures 158. The apertures 158 may be located at specific longitudinal positions along the length of the intermediate elongate member. At each longitudinal position, the apertures may be further circumferentially spaced around the intermediate elongate member 112. For example, the apertures 158 may be positioned in groups, and each group may be spaced about 90 degrees to about 120 degrees around the circumference of the intermediate elongate member 112. Each section may include about three apertures, but more or fewer are acceptable. The apertures 158 may be configured to expel air from the intermediate elongate member 112. For example, air may be expelled before introducing into a patient. The apertures 158 may expel air into the distal lumen 143 of the lead screw 140. The distal lumen 143 may be in fluid communication with the seal cap 156.

[0080] The lead screw 140 may further define a stop member 152, an elongate member retention device 150, and a seal device 154, each of which may be positioned within the proximal lumen 141 and axially relative to the longitudinal axis (L). The seal device 154 may restrict fluid from traveling between the distal lumen 143 and the proximal lumen 141. In some cases, the seal device 154 may be positioned between the stop member 152 and the elongate member retention device 150. The seal device 154 may be an O-ring, a gasket, etc. The seal device 154 may define a through-hole sized to allow the inner elongate member 110, the intermediate elongate member 112, or both the inner elongate member 110 and the intermediate elongate member 112 to extend therethrough while still maintaining a sealing property between the distal lumen 143 and the proximal lumen 141.

[0081] The elongate member retaining device 150 may be configured to engage directly or indirectly with one or more elongate members 110, 112, 114. The elongate member retaining device may include a longitudinal bore such that one or more elongate members 110, 112, 114 extend through the longitudinal bore. In some cases, the inner elongate member 110 may extend through the longitudinal bore. The elongate member retaining device 150 is configured to engage directly / indirectly with the blocking member 152 and the sealing device 154. The elongate member retaining device 150 may be configured to hold the blocking member 152 and the sealing device 154 in place relative to the adapter 140.

[0082] A blocking member 152 may be included along the length of the intermediate elongate member 112. The blocking member 152 may be configured to restrict axial movement, rotational movement, or both axial and rotational movement of the intermediate elongate member 112. The blocking member 152 may be integrally formed with the intermediate elongate member 112 and project outwardly from the intermediate elongate member. In some cases, the blocking member 152 may be mounted relative to the intermediate elongate member. For example, the blocking member 152 may be fixedly attached to the intermediate elongate member 112. The blocking member 152 may be shaped to at least partially engage with the inner cavity 141 so as to restrict movement of the intermediate elongate 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 elongate member 112 is restricted. Movement of the intermediate elongate member 112 may be restricted to axial movement corresponding to movement of the lead screw 140. The blocking member 152 may include a through hole such that at least the inner elongate member 110 may extend through the through hole.

[0083] Reference Figure 4 and Figure 5A, the recanalization device 108 includes a center 202 between a distal end 109A and a proximal end 109B of the recanalization device. Although the term center 202 is used, it should be appreciated that the center 202 can be located at any position between the distal and proximal ends that enables the functionality of the recanalization device 108. The recanalization device 108 includes a plurality of support beams or struts 204 extending from the respective distal end 109A and proximal end 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 to the center 202 of the recanalization device 108. More specifically, in the illustrated embodiment, the support struts 204 are generally similar or identical to each other, and each support strut extends from a first end 205A near the distal end 109A or proximal end 109B of the recanalization device 108 to a second end 205B near the center 202 of the recanalization device 108. Each pair of struts 204 is integrally formed with the respective first end 205A or second end 205B by ribs 203. In Figure 5B and Figure 6 the struts 204A and 204B are most clearly shown. Reference numerals 204A and 204B are used to identify Figures 4 to 6 the specific struts 204 in, in order to describe this illustrated embodiment. It should be understood that although the depicted recanalization device 108 includes support struts 204 that are generally similar or identical to each other, the support struts 204 can have different sizes from each other without departing from the spirit / scope of the present disclosure. It should also be understood that other struts 204 not specifically identified by 204A or 204B are similar to the identified struts 204A, 204B. Thus, unless otherwise indicated, the description related to the struts 204A, 204B also applies to the other struts 204 of the recanalization device 108. Accordingly, the reference numeral 204 will continue to be used to refer to the struts 204.

[0084] Each pair of adjacent support struts 204 is connected to a single junction 206, which is connected to the vertices 208 of a plurality of diamond cell struts 210. More specifically, the junction 206 is near the second end 205B of the support strut 204, and the diamond cell struts 210 extend between (i) the second end 205B of the support strut 204 extending proximally from the distal end 109A of the recanalization device 108 and (ii) the second end 205B of the support strut 204 extending distally from the proximal end 109B of the recanalization device 108.

[0085] Adjacent support struts 204 (e.g., adjacent support struts 204A, 204B) can be positioned in a parallel configuration such that support strut 204A is parallel to support strut 204B. In another embodiment, as illustrated, support struts 204A and 204B can be in a non-parallel configuration. Specifically, support struts 204A and 204B can depict a triangular configuration. In one example, support struts 204A and 204B can be further apart in a triangular configuration at a first end 205A and can be closer together at a second end 205B. In another example, support struts 204A and 204B can be further apart in a triangular configuration at a second end 205B and can be closer together at a first end 205A. The triangular configuration of support struts 204A and 204B can provide increased rigidity and torque resistance to the recanalization device 108.

[0086] In the illustrated embodiment, compared to the support from a single support strut configuration, multiple pairs of support struts 204 provide more support to the center 202 of the recanalization device 108 and the diamond cell struts 210 because the multiple pairs of support struts 204 are geometrically larger and thus increase the second moment of inertia compared to what could be achieved with a single strut configuration. That is, by pairing the support struts 204, the pair of support struts 204 provides 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. Multiple 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, in other embodiments, the recanalization device 108 can include additional or fewer pairs of support struts 204 and diamond cell struts 210. The recanalization device 108 can include multiple support struts 204 and diamond cell struts 210 having a single or multiple support struts (e.g., single, two, three, etc.). Each diamond cell strut 210 is integrally formed with two vertex members 208, and each diamond cell strut 210 has a high point 211 between the associated vertex members 208. The radial distance of the high point 211 from the longitudinal axis L (as Figure 4 shown) is greater than the radial distance of the associated vertex member 208 from the longitudinal axis.

[0087] In the illustrated embodiment, each diamond cell strut in the diamond cell struts 210 includes a plurality of teeth 212 and edge modification structures 214. The teeth 212 and edge modification structures 214 (relative to Figure 8A and Figure 8BAs described in more detail) is configured to engage clot material within a patient's vasculature. The teeth 212 are arranged in an alternating pattern. In another embodiment, the teeth 212 may be arranged in a sequential pattern. In an exemplary embodiment, some of the teeth 212 extend outwardly from a first edge 213A of the diamond-shaped unit strut 210, while other teeth 212 extend outwardly from a second edge 213B of the diamond-shaped unit strut 210. In an exemplary embodiment, the teeth 212 extend along the length of the diamond-shaped unit 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 unit strut 210 and form an uneven surface along the surface 216, such that the recanalization device 108 has more opportunities to engage clot material in the patient's vasculature. Since the teeth 212 and the edge modification structure 214 are features added to the diamond-shaped unit strut 210, the teeth 212 and the edge modification structure 214 do not negatively affect the radial force of the recanalization device 108. In the illustrated embodiment, the size and shape of the teeth 212 are designed to be trapezoidal. In other embodiments, the size and shape of the teeth 212 may be designed to be any other suitable shape, including, for example, triangular, semi-circular, etc.

[0088] The recanalization device 108 may define a collar 220. The collar 220 may be directly or indirectly connected to one or more struts 204 at the distal portion 113A, the proximal portion 113B, or both the distal portion 113A and the proximal portion 113B. The collar 220 may have a cross-sectional shape, which refers to the shape as viewed perpendicular to the longitudinal axis (L), i.e., cylindrical, quadrilateral, triangular, and combinations thereof. The collar 220 may directly or indirectly include and / or define features and / or components that extend outwardly, inwardly, or both 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 an adhesive (e.g., glue), welding, fasteners, crimping, etc.

[0089] 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 some cases, as Figures 5A to 7B shown, the recanalization device 108 may define at least two engagement members 222. The reference numerals 222A and 222B are used to identify Figures 5A to 7Ba particular engagement member 222 therein to describe this illustrative embodiment. However, it should be understood that engagement members 222A and 222B may be collectively referred to as 222. Engagement member 222A may be opposite engagement member 222B on either side of the longitudinal axis (L). Engagement member 222 may be configured to engage directly or indirectly with at least one of the elongate members 110, 112, 114, the distal end 122, the extension member 226, and combinations thereof. In one embodiment, engagement member 222 may be configured to removably engage corresponding features / elements of the extension member 226. In some cases, engagement member 222 may be fixedly attached to the extension member 226 in a permanent or semi-permanent configuration. However, the recanalization device 108 may be configured to expand and contract between a first position and a second position as discussed herein.

[0090] One or more engagement members 222 may each define one or more tabs 224 and one or more tab arms 223. Engagement member 222A may define a tab arm 223A that extends outwardly from the collar 220 toward the distal end 104. The distal portion of tab arm 223A may define a tab 224A. Engagement member 222B may define a tab arm 223B that extends outwardly from the collar 220 toward the distal end 104. The distal portion of tab arm 223B may define a tab 224B. Reference numerals 223A and 223B are used to identify Figures 5A to 7B the particular tab arms 223 therein to describe this illustrative 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 to identify Figures 5A to 7B the particular tabs 224 therein to describe this illustrative embodiment. However, it should be understood that tabs 224A and 224B may be collectively referred to as 224.

[0091] Tab arms 223A and 223B may extend outwardly from the collar 220 in a parallel, semi-parallel, and / or non-parallel configuration relative to the other tab arm and / or the longitudinal axis (L) in the direction of the distal end 104. In some cases, tab arms 223A and 223B may extend outwardly from the collar 220 in a tapered configuration in the direction of the distal end such that when tab arms 223A and 223B extend from the collar 220 in a generally longitudinal direction, the radial distance by which the end portions of tab arms 223A and 223B are separated is less than the radial distance by which tab arms 223A and 223B are separated when integrally formed with the collar 220. Tab arms 223A and 223B may be biased inwardly toward the longitudinal axis (L).

[0092] The tab arms 223A and 223B may each define a tab 224 near the distal end of each tab arm 223. Specifically, the tab arm 223A may define a tab 224A near its distal end, and the tab arm 223B may define a tab 224B near its distal end. The tabs 224A and 224B may be configured to engage directly or indirectly 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 tab 224 may define one or more features that engage directly or indirectly with the extension member 226. In another embodiment, the tab 224 may include one or more elements that engage directly or indirectly with the extension member 226. For example, the extension member 226 may define corresponding openings (not shown) to engage directly or indirectly with the tab 224. The corresponding openings may extend at least partially 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 tab 224 such that each tab 224 fits within the corresponding opening configured to receive the tab 224. In some embodiments, the tab 224 may be removably positioned at least partially within the corresponding opening of the extension member 226. In some cases, the tab 224 may be fixedly attached to the extension member 226 in a permanent or semi-permanent configuration.

[0093] In some cases, the engagement member 222 may define a geometry or include an element that includes a feature having a first portion that is narrower (or smaller) in size (e.g., diameter) than a second portion. For example, the width / diameter of the tab 224 (e.g., laterally with respect to the longitudinal axis) may be greater than the tab arm 223. Thus, the tab 224 may engage with the "keyed" opening to semi-permanently or permanently restrict movement of the recanalization device 108 relative to the extension member 226 (or alternative component).

[0094] In one embodiment, as illustrated in the figure (e.g., Figure 5B ), the tabs 224 may each define a curved surface near the longitudinal axis (L). The curved surfaces of the tabs 224A and 224B may each be positioned at least partially within the corresponding openings of the extension member 226. The corresponding openings of the extension member 226 may prevent (or restrict) longitudinal movement, lateral movement, outward movement, inward movement of the engagement member 222, and combinations thereof.

[0095] In another embodiment, the tabs 224 may each include one or more elements configured to engage at least partially with corresponding openings of the extension member 226. The corresponding openings of the extension member 226 may prevent (or limit) longitudinal movement, lateral movement, outward movement, inward movement, and combinations thereof. The one or more elements may extend in a direction generally perpendicular to the longitudinal axis, parallel to the longitudinal axis, at an angle relative to the longitudinal axis, and combinations thereof.

[0096] However, it should be understood that the tabs 224 may define or include other (or additional) geometries or elements configured to engage corresponding openings of the extension member 226, the elongate members 110, 112, 114, the distal end 122, and combinations thereof. Accordingly, the corresponding openings may be configured to engage with the corresponding tabs 224. For example, the tabs 224 and the corresponding openings may be "keyed", as described above. The "keyed" openings and the corresponding tabs 224 may each define a shape or combination of shapes selected from the group including but not limited to circular, triangular, square, star, cross, T-shaped, oval, rectangular, pentagonal, rhombus, trapezoidal, hexagonal, octagonal, and egg-shaped. The tabs 224 and the "keyed" openings may each define similar or different shapes.

[0097] However, it should also be understood that although some embodiments are discussed with reference to the extension member 226, other components of the system 100 (e.g., the elongate members 110, 112, 114, the distal end 122) may substitute for the extension member 226, unless their use conflicts with the function or design of the system 100. Additionally, it should be understood that although the engagement member 222 is illustrated as being near the distal end 109A of the recanalization device 108, a similar engagement member 222 may also be positioned near the proximal end 109B of the recanalization device 108. In some cases, the engagement member 222 may be positioned on the distal end 109A of the recanalization device 108 and on the proximal end 109B of the recanalization device 108. Moreover, the engagement members 222 positioned on either end 109A, 109B of the recanalization device 108 may have different shapes, sizes, and positions, as described herein.

[0098] The recanalization device 108 may be removed or partially removed from the system 100. The engagement member 222 may be removed or partially removed from the corresponding openings of the extension member 226, the elongate members 110, 112, 114, the distal end 122, and combinations thereof. The recanalization device 108 may be removed or partially removed for cleaning, removing extracted bodily substances, and / or replacing the recanalization device 108 with a similar or different size / shape.

[0099] In another embodiment, system 100 may further include a band 228. The band 228 may be configured to directly or indirectly limit movement of the recanalization device 108 in one or more directions semi - permanently or permanently with the engagement member 222. For example, the band 228 may limit longitudinal movement, lateral movement, outward movement, inward movement of the engagement member 222, and combinations thereof. The band 228 may define and / or include features and / or elements that limit 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 to the engagement member 222 by using adhesives, welding, fasteners, crimping, press - fitting, and combinations thereof.

[0100] As Figures 5A to 7B Illustrated, the band 228 may directly or indirectly engage the tab 224 of the engagement member 222 to semi - permanently or permanently limit 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 to 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 limit movement of the recanalization device 108 in one or more directions. The band 228 may be a continuous piece that may slide over (in the longitudinal direction) the tab 224. The band 228 may be a discontinuous single piece that may at least partially clamp (close) 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.

[0101] 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 differently configured, as further described herein, particularly with respect to Figures 12 to 13 .

[0102] Figure 8A Illustrated is an edge modification structure 214 of the diamond - cell strut 210 relative to a first edge 301A of the diamond - cell strut 210, and Figure 8B Illustrated is an edge modification structure 214 relative to a second edge 301B of the diamond - cell strut 210. The edge modification structure 214 may reduce the thickness of a portion of the diamond - cell strut 210 (e.g., the sharp edge 306), which may make the diamond - cell strut 210 more effective in grasping and / or cutting clot material included in a patient's vasculature. In some embodiments, the edge modification structure 214 is positioned along the inner diameter 301A of the denticle 212, the outer diameter 301B of the denticle 212, or both the inner diameter 301A and the outer diameter 301B of the denticle 212 (see Figure 4 andFigure 5A )。In some embodiments, the denticle 212 may have an edge modification structure 214 added to the first edge 301A of the denticle 212, and adjacent denticles 212 may have an edge modification structure 214 added to the second edge 301B. In other embodiments, all of the denticles 212 may have the same edge modification structure 214, or the denticles 212 may have any other configuration of the edge modification structure 214.

[0103] Figure 8A and Figure 8B the edge modification structures 214 are substantially similar, except that, in Figure 8A , the sharp edge 306 of the edge modification structure 214 abuts the first edge 301A. In contrast, in Figure 8B , the sharp edge 306 of the edge modification structure 214 abuts the second edge 301B. This depends on the position of the edge modification structure 214 (e.g., whether it abuts the first edge 301A or the second edge 301B). The sharp edge 306 is close to the first edge 301A or the second edge 301B of the diamond cell strut 210, or, in some embodiments, the sharp edge 306 may be within the thickness of the diamond cell strut 210. The edge modification structure 214 may be formed via off-axis laser cutting or post-processing. Additionally, multiple types of edge modification structures 214 (e.g., at the inner diameter 301A, at the second edge 301B, or over the entire thickness of the diamond cell strut) may be included in the same diamond cell strut 210 and / or the same recanalization device 108 (as Figures 4 to 6 illustrated).

[0104] Figure 9A and Figure 9B respectively illustrate a first position 402 of the recanalization device 108 (e.g., the recanalization device 108 shown in a radially expanded position relative to the longitudinal axis (L) as Figures 1A to 3D illustrated) and a second position 404 (e.g., Figures 1A to 3DThe recanalization device 108 shown is in a radially compressed position relative to the longitudinal axis L), and comparison with 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 less than the first diameter D1 and a second length X2 that is greater than the first length X1. The diameters D1, D2 are measured from i) the outermost first portion 406 of the diamond cell struts 210 of the recanalization device 108 that is radially farthest from the inner elongate member 110 to ii) the outermost second portion 408 of the diamond cell struts 210 of the recanalization device 108 that is radially farthest from the inner elongate member 110 in the direction opposite the outermost first portion 406. The lengths X1, X2 are measured from the distal portion 109A to the proximal portion 109B of the recanalization device 108. In the first position 402 and the second position 404, the recanalization device 108 has been distally advanced out of the outer elongate member 114, as Figure 1A shown (e.g., through the distal portion 115A of the outer elongate member 114, as Figure 1A shown).

[0105] To move the recanalization device 108 into the first position 402, the user can rotate the actuator 136 (as Figures 1A to 3D shown) to drive the lead screw 140 distally or proximally to the desired size (e.g., the ratio of diameter to length) of the recanalization device 108, as depicted by the indicator scale 138. For example, movement of the lead screw 140 in the distal direction drives the intermediate elongate member 112 distally past the inner elongate member 110, thereby driving the proximal portion 109B of the recanalization device 108 distally toward the distal portion 109A to radially expand the recanalization device 108 while shortening the recanalization device 108. Movement of the lead screw 140 in the proximal direction drives the intermediate elongate member 112 proximally past the inner elongate member 110 (which remains fixed or mostly fixed), thereby driving the proximal portion 109B of the recanalization device 108 proximally away from the distal portion 109A to radially compress the recanalization device 108 while increasing the length of the recanalization device 108.

[0106] Refer to Figures 1A to 3D, the indicating scale 138 of the handle portion 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 indicating 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 indicating scale 138 includes an opening for viewing the indicator 139 of the lead screw 140. The indicating scale 138 may include a scale showing the relative size of the recanalization device 108. In other embodiments, the indicating 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.

[0107] To move the recanalization device 108 to the second position 404, the user may compress the trigger mechanism 124 to extend the inner elongate member 110 in the distal direction until the recanalization device 108 reaches a desired size (e.g., the ratio of diameter to length). Specifically, the user may compress the gripping portion 126 of the trigger mechanism 124, which translates the adapter 142 via the linkage 128. During the compression of the gripping portion 126, the user compresses the biasing member 127 to longitudinally translate the adapter 142, and the biasing member 127 is mounted relative to the distal portion of the adapter 142. As described above, the inner elongate member 110 is constrained by the adapter 142, and thus, as the adapter 142 moves distally, the inner elongate member 110 also moves distally, thereby driving the distal portion 109A of the recanalization device 108 away from the proximal portion 109B in the distal direction to radially compress the recanalization device 108, which elongates the recanalization device 108. Since the distal movement of the adapter 142 (and the inner elongate member 110) must overcome the biasing member 127, the user may compress the recanalization device 108 by any amount, and the recanalization device 108 will maintain that size, which is referred to as the second position 404. Completely releasing the gripping portion 126 will cause the recanalization device 108 to return to the first position 402. In some embodiments, the proximal portion of the lead screw 140 may act as a stop for the adapter 142 to ensure that the recanalization device 108 is not compressed to the extent that it damages the device 108.

[0108] The relative movement of the elongate members 110, 112 lengthens (as shown in the second position 404) and / or shortens (as shown in the first position 402) the distance between the distal end 109A and the proximal end 109B of the recanalization device 108 to radially expand (as shown in the first position 402) and / or compress (as shown in the second position 404) the recanalization device 108. Although in Figure 9A and Figure 9BTwo discrete positions 402, 404 are shown, but the recanalization device can expand to any number of continuous positions therebetween, expand to a position that is radially expanded more than the first position 402, and / or expand to a position that is radially expanded less than the second position 404.

[0109] In some embodiments, when the recanalization device 108 is positioned within the outer elongate member 114, the recanalization device 108 can be in a compressed position. In some cases, in a fully compressed or near fully compressed position. As the recanalization device 108 moves distally from the outer elongate member 114, the recanalization device 108 can remain in the compressed position. Then, the user can adjust the actuator 136 to a desired first position 402, as described herein. Thus, the user has full control over the size of the recanalization device 108 and the positions 402, 404 of the recanalization device 108.

[0110] In operation, the inner elongate member 110 can move relative to the port housing 134, but can maintain fluid connection with the port 135. At the first position 402 of the recanalization device 108, the inner elongate member 110 can be positioned within the port housing 134 having a first length. At the second position 404 of the recanalization device 108, the inner elongate member 110 can be positioned within the port housing 134 having a second length. Although the second length of the inner elongate member 110 can be shorter than the first length, the second length can be sufficient to maintain fluid connection with the port 135.

[0111] The recanalization device 108 can be configured to deform when engaged with an obstruction (e.g., a vein segment, clot material within the 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 when engaged with an obstruction (e.g., a vein segment, clot material within the 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 so as to locally deform in the region where it is engaged with the obstruction, but if desired, the recanalization device can be rigid to clear the obstruction. 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.

[0112] Figure 10 is used by a user (e.g., a physician, a clinician, etc.) using the system 100 (relative to Figures 1A to 3DFlowchart of method 500 performed as shown and described. In step 510, the elongate members 110, 112, 114 are advanced within a blood vessel to a target location within a patient (e.g., a venous segment including chronic clotting material). In some cases, the target location can be a location before and / or after a venous segment including chronic clotting material. Once in the target location, in step 520, the recanalization device 108 is withdrawn from the sheath and then radially expanded to engage the vasculature at the target location. Then, in step 530, the recanalization device 108 is axially moved (e.g., in a scraping or rotational motion) to remove chronic clot material from the target location. Once the chronic clot material is removed from the target location, if desired, in step 540, the trigger mechanism 124 can be engaged to advance and / or retract the elongate members 110, 112, 114 to a second position. At the second position, the recanalization device 108 can treat the diseased blood vessel in step 550, as described above. During use, if the user engages resistance by external compression or the like, the trigger mechanism 124 can be engaged to temporarily reduce the diameter of the recanalization device 108 (e.g., reducing the diameter to less than a first diameter D1). Method 500 ends at step 560 with the withdrawal of the elongate members from the patient's body.

[0113] Figure 11 The recanalization system 600 is shown. The recanalization system 600 is substantially similar to the recanalization system 100 as shown and described with respect to Figures 1A to 3D except that the recanalization system 600 includes an outer elongate member 602 that functions differently from the outer elongate member 114 of the recanalization system 100.

[0114] Specifically, the outer elongate member 602 has a larger diameter than the outer elongate member 114 and is equipped with a system (not shown) that can be configured to allow removal of the removed clot material by suction. For example, when the recanalization device 108 removes material, the removed clot material can be captured within the lumen of the outer elongate member 602. That is, the outer elongate member 602 can define an internal path within the lumen for the removed clot material to flow out from the recanalization device 108. When the elongate members 110, 112, 602 are withdrawn and / or removed from the patient's body, a suction device can be attached to the side port 120, as Figures 1A to 3D shown, to remove the removed clot material from the lumen of the outer elongate member 602. In other embodiments, suction of the removed clot material can occur while the elongate members 110, 112, 602 and the recanalization device 108 are still within the patient's vasculature and operating therein.

[0115] Figure 12 and Figure 13 illustrates the recanalization device 108 of the recanalization system 100 (as shown and described with respect to Figures 1A to 3D shown and described)Figures 1A to 9B the different embodiments shown and described)

[0116] Now referring to Figure 12 , a recanalization device 700 is shown. The recanalization device 700 is substantially similar to the recanalization device 108 shown and described with respect to Figures 1A to 9B , except that the recanalization device 700 has a different configuration 702 of struts 704, as described below.

[0117] The recanalization device 700 extends from a proximal end 701B to a distal end 701A. The distal end 701A includes a non-invasive shape. At the center of the recanalization device 700 (e.g., the area between the distal end 701A and the proximal end 701B), diamond cell struts 706 are configured to allow a collection bag (not shown) to be attached to the plurality of diamond cell struts 706. In some embodiments, when the recanalization device 700 operates within a patient's vasculature to reduce the risk of a thromboembolic event in the patient, the collection bag may collect the removed clot material. The recanalization device 700 includes a floating shaft 708 that is configured to transmit force from an intermediate elongate member 112 (e.g., as Figure 1A shown) to the center of the recanalization device 700 and a weld ring 710. The floating shaft 708 allows the weld ring 710 to move relative to the intermediate elongate member 112, which allows the recanalization device 700 to be crimped. In other embodiments, the floating shaft 708 may be coupled to a distal portion 113A of the intermediate elongate member 112 or the weld ring 710. Additionally, in some embodiments, a full ring (not shown) 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 intermediate elongate member 112 to the distal end 701A of the recanalization device 700.

[0118] Figure 13is a perspective view of a recanalization device 1600 including a harpoon-shaped strut 1602. The harpoon-shaped strut 1602 includes a metallic structure having arms 1604 with free ends positioned distally of the harpoon-shaped strut 1602 and fixed 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-shaped strut 1602 is positioned within clot material and rotated about axis A to apply tension to the clot. At the same time, a second device (not shown) including wall apposition may be advanced or retracted over the harpoon-shaped strut 1602 to remove clot material from the vessel wall. This usage may mimic endovenectomy and how tension is applied to clot material prior to cutting the clot material. Similarly, the harpoon-shaped strut 1602 is configured to apply tension prior to radially cutting the clot from the vessel wall using another device. Additionally, the recanalization device 1600 and the harpoon-shaped strut 1602 may be used to cut through adherent clot similar to an inverted valvulotome. That is, the recanalization device 1600 may be deployed through the clot and retracted through the lesion site. The shape of the free end of the recanalization device 1600 may be configured to prevent vessel wall trauma and limit engagement of side branches. When 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.

[0119] The following clauses further define specific aspects and embodiments of the present disclosure.

[0120] Clause 1. A recanalization system, comprising: a handle located at a proximal end of the system; a first elongate member; and a second elongate member. The first elongate member and the second elongate member are movable relative to one another; and a recanalization device located at a distal end of the system. The recanalization device comprises: a first end portion coupled to the first elongate member; a second end portion coupled to the second elongate member; and at least one strut extending between the first end portion and the second end portion. The recanalization device is configured to (i) selectively expand and compress radially, and (ii) move axially relative to the first elongate member and the second elongate member.

[0121] Clause 2. The recanalization system according to clause 1, wherein the axial movement of the recanalization device is at least one of (i) axial back-and-forth translation or scraping and (ii) rotation.

[0122] Clause 3. The recanalization system according to any of the preceding clauses, wherein the first elongate member and the second elongate member are catheters, wherein the catheters are hypotubes, and wherein the hypotubes are formed of nitinol.

[0123] Clause 4. A recanalization system as described in any of the preceding Clause 1, wherein the recanalization device further comprises a third elongated member, wherein the first elongated member and the second elongated member are included within the lumen of the third elongated member, and wherein the first elongated member and the second elongated member are capable of moving relative to the third elongated member.

[0124] Clause 5. The recanalization system according to Clause 4, wherein the third elongated member is a suction catheter, a delivery catheter, or a guiding catheter, and wherein the third elongated member comprises a braid or a coil reflux configuration.

[0125] Clause 6. A recanalization system as described in any of the preceding clauses, wherein the handle comprises an actuator, an indicating scale, and a lead screw rotatably coupled to the actuator, and wherein the actuator and the lead screw are configured to move the second elongated member relative to the first elongated member.

[0126] Clause 7. A recanalization system as described in any of the preceding clauses, wherein the proximal end of the second elongated member is coupled to the lead screw, and wherein the lead screw is actuated by the actuator.

[0127] Clause 8. A recanalization system as described in any of the preceding clauses, wherein the lead screw defines an indicator configured to move relative to the indicating scale of the handle to visually display the degree of radial expansion of the at least one strut of the recanalization device.

[0128] Clause 9. A recanalization system as described in any of the preceding clauses, wherein the handle further comprises a trigger mechanism coupled to the first elongated member, wherein when actuated, the trigger mechanism is configured to advance the recanalization device from a first position to a second position, thereby radially contracting the recanalization device from an expanded configuration.

[0129] Clause 10. The recanalization system according to Clause 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.

[0130] Clause 11. A recanalization system as described in any of the preceding clauses, wherein the recanalization device is a stent.

[0131] Clause 12. A recanalization system as described in any of the preceding clauses, wherein the recanalization device further comprises a third portion extending between the first end portion and the second end portion.

[0132] Clause 13. The recanalization system as described in Clause 12, wherein at least one strut of the recanalization device includes multiple pairs of support struts, wherein a first subset of the multiple pairs of support struts extends from the first end portion towards the third portion, and wherein a second subset of the multiple pairs of support struts extends from the second end portion towards the third portion.

[0133] Clause 14. The recanalization system as described in Clause 13, wherein the multiple pairs of support struts include six pairs of support struts, and wherein the first subset includes three pairs of support struts, and wherein the second subset includes three pairs of support struts.

[0134] Clause 15. The recanalization system as described in any one of Clauses 12 to 14, wherein the at least one strut of the recanalization device further includes a plurality of diamond unit struts extending between the support struts at the third portion of the recanalization device.

[0135] Clause 16. The recanalization system as described in Clause 15, wherein the plurality of diamond unit struts includes six diamond unit struts.

[0136] Clause 17. The recanalization system as described in any one of Clauses 15 to 16, wherein each pair of support struts is connected to a single joint, and the single joint is connected to the vertices of each diamond unit strut.

[0137] Clause 18. The recanalization system as described in any one of Clauses 15 to 17, wherein each diamond unit strut of the diamond unit struts includes a plurality of denticles along the length of the diamond unit strut, and wherein each diamond unit strut of the diamond unit struts includes two edges.

[0138] Clause 19. The recanalization system as described in Clause 18, wherein the size and shape of the denticles are designed as at least one of trapezoidal, triangular, and semi-circular.

[0139] Clause 20. The recanalization system as described in any one of Clauses 18 to 19, wherein the edge of each diamond unit strut at least partially includes an edge modification structure, and the edge modification structure includes a thickness reduction portion of the edge, and the thickness reduction portion terminates at a sharp edge.

[0140] Clause 21. The recanalization system as described in any of the foregoing clauses, wherein the collection bag is included within the recanalization device and extends from the first end portion to the second end portion.

[0141] Clause 22. The recanalization system as described in any of the foregoing clauses, wherein the first elongated member and the second elongated member are included within the suction device and are movable relative to the suction device.

[0142] Clause 23. A recanalization system as described in any of the preceding clauses, wherein the recanalization device further comprises two opposing tabs extending outwardly from the first end portion or the second end portion of the recanalization device, the two opposing tabs being configured to bias inwardly towards each other, and wherein the two opposing tabs are configured to engage directly or indirectly with at least one of the first elongate member or the second elongate member.

[0143] Clause 24. The recanalization system as described in Clause 23, further comprising a band configured to engage the two opposing tabs of the recanalization device, wherein the band is configured to restrict movement of the two opposing tabs of the recanalization device.

[0144] Clause 25. A method for recanalization, comprising: (i) advancing a plurality of elongate members of a recanalization system within a blood vessel 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 a coagulated substance at the target location; and (iv) withdrawing the plurality of elongate members of the recanalization system from the patient's body.

[0145] Clause 26. The method as described in Clause 25, further comprising: (i) engaging a trigger mechanism of the recanalization system to advance or retract the plurality of elongate members to a second position; and (ii) removing a coagulated substance from the second position.

[0146] Clause 27. A recanalization device, comprising: a first end and a second end, and a center therebetween, the first end and the second end being spaced apart along an axis, the first end and the second end being movable towards and away from the center of the recanalization device; at least one strut member extending away from each of the first end and the second end and terminating at a vertex member; a diamond unit strut extending between two vertex members and integral with the two vertex members, each diamond unit strut comprising: opposing outwardly directed edges; and a plurality of tooth-like structures positioned along each edge.

[0147] Clause 28. The recanalization device as described in Clause 27, wherein the diamond unit strut member comprises a plurality of tooth-like structures along each of the opposing edges.

[0148] Clause 29. The recanalization device as described in Clause 28, wherein the plurality of tooth-like structures along one edge are spaced apart, and wherein each of the tooth-like structures along a second edge is laterally aligned with a space separating adjacent tooth-like structures along the one edge.

[0149] Clause 30. A recanalization device as described in any one of Clauses 27 to 29, wherein the diamond unit strut member includes three denticles along one edge and two denticles along the opposite edge.

[0150] Clause 31. A recanalization device as described in any one of Clauses 27 to 30, wherein the recanalization device includes a plurality of strut members extending away from each of the first end and the second end.

[0151] Clause 32. The recanalization device as described in Clause 31, wherein the recanalization device includes six strut members extending away from each of the first end and the second end.

[0152] Clause 33. A recanalization device as described in any one of Clauses 27 to 32, wherein the recanalization device includes three pairs of strut members extending from each of the first end and the second end, and wherein each pair of struts terminates at a vertex member.

[0153] Clause 34. A recanalization device as described in any one of Clauses 27 to 33, wherein the denticles terminate at cutting edges.

[0154] Clause 35. A recanalization device as described in any one of Clauses 27 to 34, wherein each of the denticles has an adjustment surface in a trapezoidal shape.

[0155] Clause 36. A recanalization device as described in any one of Clauses 27 to 35, wherein each of the diamond unit strut members has a high point, and the distance of the high point from the axis of the recanalization device is greater than the distance of the diamond unit strut end integrated with the vertex member from the axis of the recanalization device.

[0156] Clause 37. The recanalization device as described in any one of Clauses 27 to 36, further including two opposite tabs extending outward from the first end portion or the second end portion, and the two opposite tabs are configured to bias inwardly towards each other.

[0157] The above detailed description of embodiments of the present disclosure is not intended to be exhaustive or to limit the present disclosure to the precise forms disclosed above. Although specific embodiments and examples of the present disclosure are described above for illustrative purposes, various equivalent modifications within the scope of the present disclosure are possible as would be recognized by those skilled in the relevant art. For example, although steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0158] As described above, it should be understood that specific embodiments of the present disclosure have been described herein for illustrative purposes, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present disclosure. Where context permits, singular or plural terms may also respectively include plural or singular terms.

[0159] In addition, unless the word "or" is explicitly limited to mean only a single item that is mutually exclusive from other items when referring to a list of two or more items, the use of "or" in such a list shall be construed to include (i) any single item in the list, (ii) all items in the list, or (iii) any combination of items in the list. Additionally, the terms "comprising" and "including" are used throughout to mean including at least the recited feature, such that any greater number of the same feature and / or additional types of other features are not excluded. It should also be understood that specific embodiments have been described herein for illustrative purposes, but various modifications can be made without departing from the present disclosure. Moreover, although 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 must exhibit such advantages to fall within the scope of the present disclosure. Accordingly, the present disclosure may cover other embodiments not explicitly shown or described herein.

Claims

1. A recanalization system, comprising: A handle located at the proximal end of the system; A first elongate member; A second elongate member, the first elongate member and the second elongate member being movable relative to each other as elongate members; And A recanalization device located at the distal end of the system and comprising: A first end portion coupled to the first elongate member; A second end portion coupled to the second elongate member; and At least one strut extending between the first end portion and the second end portion; Wherein the recanalization device is configured to (i) selectively expand and compress radially, and (ii) move axially relative to the first elongate member and the second elongate member.

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

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

4. The recanalization system according to claim 1, wherein the recanalization device further comprises a third elongate member, wherein the first elongate member and the second elongate member are included within the lumen of the third elongate member, and wherein the first elongate member and the second elongate member are movable relative to the third elongate member.

5. The recanalization system according to claim 4, wherein the third elongate member is an aspiration catheter, a delivery catheter, or a guiding catheter, and wherein the third elongate member comprises a braid or a coil return configuration.

6. The recanalization system according to claim 1, wherein the handle comprises an actuator, an indicating scale, and a lead screw rotatably coupled to the actuator, and wherein the actuator and the lead screw are configured to move the second elongate member relative to the first elongate member.

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

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

9. The recanalization system according to claim 1, wherein the handle further comprises a trigger mechanism coupled to the first elongate member, wherein when actuated, the trigger mechanism is configured to 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 according to claim 9, wherein when released, a biasing member coupled to the trigger mechanism is configured to return the first elongate member to the first position, thereby expanding the recanalization device to the expanded configuration.

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

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

13. The recanalization system according to claim 12, wherein the at least one strut of the recanalization device includes multiple pairs of support struts, wherein a first subset of the multiple pairs of support struts extends from the first end portion towards the third portion, and wherein a second subset of the multiple pairs of support struts extends from the second end portion towards the third portion.

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

15. The recanalization system according to claim 14, wherein the at least one strut of the recanalization device further includes multiple diamond unit struts extending between the support struts at the third portion of the recanalization device.

16. The recanalization system according to claim 15, wherein the multiple diamond unit struts include six diamond unit struts.

17. The recanalization system according to claim 16, wherein each pair of support struts is connected to a single joint, and the single joint is connected to the vertices of each diamond unit strut.

18. The recanalization system according to claim 15, wherein each diamond unit strut of the diamond unit struts includes multiple denticles along the length of the diamond unit strut, and wherein each diamond unit strut of the diamond unit struts includes two edges.

19. The recanalization system according to claim 18, wherein the size and shape of the denticles are designed as at least one of a trapezoid, a triangle, and a semi - circle.

20. The recanalization system according to claim 18, wherein the edge of each diamond unit strut at least partially includes an edge modification structure, and the edge modification structure includes a thickness reduction portion of the edge, and the thickness reduction portion terminates at a sharp edge.

21. The recanalization system according to claim 1, wherein the collection bag is included within the recanalization device and extends from the first end portion to the second end portion.

22. The recanalization system according to claim 1, wherein the first elongated member and the second elongated member are included within a suction device and are movable relative to the suction device.

23. The recanalization system according to claim 1, wherein the recanalization device further includes two opposite tabs extending outwardly from the first end portion or the second end portion of the recanalization device, the two opposite tabs being configured to bias inwardly towards each other, and the two opposite tabs being configured to directly or indirectly engage at least one of the first elongated member or the second elongated member.

24. The recanalization system according to claim 23, further including a band configured to engage the two opposite tabs of the recanalization device, and the band is configured to limit the movement of the two opposite tabs of the recanalization device.

25. A method for recanalization, comprising: Advance a plurality of elongate members of a recanalization system into a patient's body to a target location within a blood vessel; Radially expand a recanalization device of the recanalization system to engage with the target location; Axially move the recanalization device to remove coagulated material at the target location; And Withdraw the plurality of elongate members of the recanalization system from the patient's body.

26. The method according to claim 25, further comprising: Engage a trigger mechanism of the recanalization system to advance or retract the plurality of elongate members to a second position; And Remove coagulated material from the second position.

27. A recanalization device, comprising: 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, the at least one strut member extending away from each of the first end and the second end and terminating at a vertex member; A rhombic unit strut, the rhombic unit strut extending between two vertex members and being integral with the two vertex members, each rhombic unit strut comprising: Opposite outwardly directed edges; And A plurality of teeth, the plurality of teeth being positioned along each edge.

28. The recanalization device according to claim 27, wherein the rhombic unit strut member comprises a plurality of teeth along each of the opposite edges.

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

30. The recanalization device according to claim 29, wherein the rhombic unit strut member comprises three teeth along one edge and two teeth along the opposite edge.

31. The recanalization device according to claim 27, wherein the recanalization device comprises a plurality of strut members extending away from each of the first end and the second end.

32. The recanalization device according to claim 31, wherein the recanalization device comprises six strut members extending away from each of the first end and the second end.

33. The recanalization device according to claim 30, wherein the recanalization device comprises three pairs of strut members extending from each of the first end and the second end, and wherein each pair of struts terminates at a vertex member.

34. The recanalization device according to claim 30, wherein the teeth terminate at a cutting edge.

35. The recanalization device according to claim 34, wherein each of the teeth has an adjustment surface in a trapezoidal shape.

36. The recanalization device according to claim 27, wherein each rhombic unit strut member of the rhombic unit strut members has a high point, the distance of the high point from the axis of the recanalization device being greater than the distance of the end of the rhombic unit strut integral with the vertex member from the axis of the recanalization device.

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

Images