Clot retrieval device having a flexible, collapsible frame - Patent Application 20070122997

Abstract

To provide a clot retrieval device.SOLUTION: The clot retrieval device includes an inner expandable member and an outer expandable member formed from respective strut frameworks so that the outer expandable member has larger cell openings than the inner expandable member. The outer expandable member can have multiple discontinuous body segments spaced in relation to a longitudinal axis of the device. Adjacent discontinuous body segments can be joined by a pair of tapered connecting arms that are able to bend with a small radius of curvature compared to the body segments. Some or all of the body segments can include radiopaque markers positioned to illustrate the circumference of the respective body segments and slightly staggered in relation to the longitudinal axis of the device such that the markers nest when the device is collapsed for delivery.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] The present invention relates to devices and methods for removing acute obstructions from blood vessels. More particularly, the present invention relates to removing obstructions from cerebral arteries in patients with acute ischemic stroke (AIS), from pulmonary arteries in patients with pulmonary embolism (PE), from coronary arteries or coronary graft vessels in patients with myocardial infarction (MI), and from other peripheral arterial and venous vessels occluded by clots or other obstructing material (such as device misplacement, device migration, large emboli, etc.). [Background technology]

[0002] Thromboembolism occurs when part or all of a thrombus breaks off from the blood vessel wall. This clot (referred to herein as an embolus) is then carried in the direction of blood flow. Ischemic stroke can result when a clot lodges in the vasculature of the brain. Pulmonary embolism can result when a clot originates in the venous system or the right side of the heart and lodges in the pulmonary artery or its tributaries. Clots can also develop in the form of emboli without being released, locally blocking a blood vessel; this mechanism is common in the formation of coronary artery blockages.

[0003] Numerous access challenges exist that make it difficult to deliver treatment devices to blood clots or other obstructions. When access involves navigating the aortic arch (such as in coronary or cerebral occlusions), the shape of the aortic arch in some patients makes it difficult to position a guide catheter. These challenging aortic arch configurations are classified as type II or type III aortic arches, with type III aortic arches presenting the greatest obstacles. The tortuosity problem is even more severe in arteries approaching the brain. For example, it is not uncommon at the distal end of the internal carotid artery for a device to navigate several centimeters of vessel through vessel segments with 180°, 90°, and 360° bends. In the case of pulmonary embolism, access can be gained through the venous system and then through the right atrium and right ventricle of the heart. The right ventricular outflow tract and pulmonary artery are delicate vessels that can be easily damaged by inflexible or high-profile devices. For these reasons, it is desirable for obstruction retrieval devices to be compatible with delivery catheters that are low-profile and highly flexible.

[0004] The vasculature in areas where a blood clot may be lodged is often fragile and delicate. For example, neurovascular vessels are more fragile than similarly sized vessels in other parts of the body and reside in soft tissue beds. Excessive tensile force applied to these vessels can result in perforation and bleeding. Pulmonary vessels are larger than those of the cerebral vasculature, but are also inherently delicate, especially the finer vessels.

[0005] Clots can include any of a range of morphologies and consistencies. Long, string-like, softer clot material tends to bifurcate or trifurcate, resulting in simultaneous occlusion of multiple vessels over significant lengths. More mature, organized clot material may be less compressible than softer, new clots and, under the influence of blood pressure, may distend the flexible vessels within which it is lodged.

[0006] Not only do blood clots vary in shape and consistency, but they can also vary greatly in length, even in any one given region of the anatomy. For example, a blood clot occluding the middle cerebral artery in an ischemic stroke patient can range in length from just a few millimeters to several centimeters.

[0007] Stent-like clot retrievers have been used to remove clots or other obstructions from the cerebral blood vessels of patients with acute stroke. These are self-expanding devices similar in appearance to stents mounted on the end of a long shaft that are advanced through a microcatheter and deployed across the clot obstructions to capture and retrieve them. Self-expanding devices rely on a pinning mechanism to grasp the clot by trapping it between a self-expanding stent-like body and the vessel wall.

[0008] A stent-like clot retriever relies on its outward radial force (RF) to maintain its grip on the clot. If the RF is too low, the stent-like clot retriever loses its grip on the clot, but if the RF is too high, the stent-like clot retriever may injure the vessel wall and require excessive force to extract. Because clot morphology varies from patient to patient, the RF required to capture the clot also varies. Because the fragility or geometry of the vessel also varies from patient to patient, the RF required to reduce the risk of vascular trauma also varies.

[0009] In some procedures, some known stent-like clot retriever designs can lose their grip on the clot when retracted proximally around a bend in a tortuous vessel. This occurs because the struts of the stent-like clot retriever are placed under tension when retracted. This tension is due to friction between the device and the vessel and increases when additional loads, such as those caused by the clot, are applied. At the bend, the struts on the outside of the bend are placed under higher tension than the struts on the inside. To achieve the lowest possible energy state, the outer surface of the stent moves toward the inner surface of the bend, reducing the tension in the struts but also reducing the expanded diameter of the stent-like clot retriever.

[0010] Some treatments rely on sandwiching the clot between a stent-like clot retriever and the vessel wall and therefore may not effectively restrain the clot when passing through a branch vessel or when entering a vessel larger than the fully expanded diameter of the stent-like clot retriever. Sandwiching the clot between a stent-like clot retriever and the vessel wall to remove the clot from the vessel can result in high shear forces against the sides of the clot as it is removed, potentially releasing clot fragments. If these fragments are not retained by the device, they can be released and cause further blockage in the distal vasculature.

[0011] In some procedures, the stent-like clot retriever may be shorter than the clot itself. A device that is shorter than the clot may not be able to restore flow through the occluded area upon deployment, and therefore the pressure gradient across the clot remains a significant obstacle to its removal. Simply lengthening such a device would make it difficult to track through tortuous anatomical structures, may cause trauma to the vasculature, require more force to extract, may become stuck, and may require surgery to remove.

[0012] For many reasons, including some or all of the limitations described above, physicians often need to make multiple passes of the clot retrieval device to completely remove an occlusive clot. However, each time the clot retrieval device is withdrawn, access to the target site is lost. The initial access step of placing a large-bore catheter does not need to be repeated because it remains in place after the initial clot retrieval attempt. Only the step of accessing the clot site after the large-bore catheter is placed needs to be repeated. Therefore, it is necessary to re-advance the guidewire and microcatheter to access and re-cross the clot, then remove the guidewire and advance the clot retrieval device through the microcatheter. Navigating the guidewire and microcatheter to the clot can take a significant amount of time, especially if the vessel is tortuous. All of this additional time and device manipulation increases the risk to which the patient is exposed. Summary of the Invention [Means for solving the problem]

[0013] Examples disclosed herein generally include clot retrieval devices having inner and outer expandable members, each formed from a respective strut framework such that the outer expandable member has larger cell openings than the inner expandable member. The outer expandable member can have a plurality of discontinuous body segments spaced apart relative to the longitudinal axis of the device. Adjacent discontinuous body segments can be joined by a pair of tapered connecting arms that can bend at a smaller radius of curvature compared to the body segments. This smaller radius of curvature can have a range of values ​​depending on the tortuosity of the vasculature in which the device is to be expanded, with the value approximately equal to about 0 mm when the device is in a straight vessel and approximately equal to about 0.5 mm when the device is in a vessel with a 180-degree bend. Some or all of the body segments can include radiopaque markers positioned to indicate the circumference of the respective body segment and slightly staggered relative to the longitudinal axis of the device so that the markers nest when the device is collapsed for delivery.

[0014] An exemplary clot retrieval device has a collapsed configuration and an expanded configuration. The clot retrieval device is configured to remove a clot from a blood vessel. The clot retrieval device has an inner expandable member and an outer expandable member. The inner expandable member has a first framework of struts and the outer expandable member has a second framework of struts. The second framework at least partially radially surrounds the inner expandable member.

[0015] The closed cells of the second framework of the outer expandable member can be larger than the closed cells of the first framework of the inner expandable member.

[0016] The outer expandable member can have a first body segment and a second body segment connected by two connecting arms, with the first body segment positioned proximally relative to the second body segment. Each of the two connecting arms can have a tapered shape that is wider when the arm is near the first proximal body segment and narrower when the arm is near the second distal body segment. As shown in FIGS. 1B and 4C, approximate values ​​for the labeled dimensions are as follows: height "H" has a value of 0.075 mm, strut width "W1" has a value of 0.16 mm, strut width "W2" has a value of 0.08 mm, and strut width "W3" has a value of 0.20 mm. Thus, the approximate percentage change in width between "W1" and "W2" is a 50% decrease, and the approximate percentage change in width between "W2" and "W3" is a 60% increase. The outer expandable member can have additional body segments connected to the first and / or second body segments by additional connecting arms.

[0017] The outer expandable member can have at least two inlet openings within the second framework, including a pair of inlet openings between the first body segment and the second body segment, and each of the two inlet openings between the first body segment and the second body segment can have a respective opening bounded by the first body segment, the second body segment, and two connecting arms.

[0018] The first body segment can have at least two pairs of struts, each terminating in a respective distal apex and forming a proximal boundary for a respective one of the two entrance openings.

[0019] The two connecting arms between the first and second body segments of the outer expandable member can extend substantially parallel to the longitudinal axis of the device.

[0020] The two connecting arms between the first and second body segments of the outer expandable member can be positioned approximately 180° from each other around the circumference of the outer expandable member.

[0021] The first body segment and the second body segment can be connected to each other only via the two connecting arms.

[0022] Each of the two connecting arms can be configured to bend with a curvature having a radius that is smaller than the radius of curvature of the majority of the struts of the first body segment and the second body segment when pulled proximally through a tubular vasculature that includes a bend of approximately 180°.

[0023] The outer expandable member can have three or more body segments each shaped substantially similarly to the first and second body segments. The outer expandable member can include pairs of tapered connecting arms such that each respective pair of tapered connecting arms joins a longitudinally adjacent one of the three or more body segments. The tapered connecting arms can be shaped and oriented similarly to the connecting arms between the first and second body segments.

[0024] One or both of the first and second body segments may each include four or more radiopaque markers positioned about the circumference of the respective body segment. When the clot retrieval device is in the collapsed configuration, each of the radiopaque markers may be offset from adjacent radiopaque markers of the four or more radiopaque markers. The markers may be offset from adjacent radiopaque markers with respect to a longitudinal axis of the device. When the clot retrieval device is in the collapsed configuration, alternating radiopaque markers of the four or more radiopaque markers may be aligned in a plane perpendicular to the longitudinal axis.

[0025] The first body segment can include a first set of four or more radiopaque markers. The second body segment can include a second set of four or more radiopaque markers. When the clot retrieval device is in the expanded configuration, the first set of four or more radiopaque markers and the second set of four or more radiopaque markers are spaced apart approximately 8 millimeters, measured along the longitudinal axis. When the clot retrieval device is in the collapsed configuration, the first set of four or more radiopaque markers and the second set of four or more radiopaque markers are spaced apart approximately 10 millimeters, measured along the longitudinal axis.

[0026] Each of the four or more radiopaque markers may include a radiopaque material positioned within the eyelet.

[0027] At least two of the four or more radiopaque markers may be aligned with respective ones of the two connecting arms along the longitudinal axis.

[0028] Another example clot retrieval device can have a collapsed configuration and an expanded configuration. The clot retrieval device is configured to remove a clot from a blood vessel. The structure and functionality of the clot retrieval device of this example can be combined with the structure and features of the clot retrieval device of the previous example.

[0029] An exemplary clot retrieval device includes an inner expandable member having a first framework of struts and an outer expandable member having a second framework of struts. The second framework of struts can form closed cells that are larger than the closed cells of the first framework of the inner expandable member. The second framework can at least partially radially surround the first framework of the inner expandable member.

[0030] An exemplary clot retrieval device can include four or more radiopaque markers attached to the second framework of struts and positioned to indicate the circumference of the outer expandable member. The radiopaque markers can be further positioned such that when the clot retrieval device is in a collapsed configuration, each radiopaque marker is offset relative to its respective circumferentially adjacent radiopaque marker with respect to the longitudinal axis of the device.

[0031] The outer expandable member can include discrete body segments spaced apart along the longitudinal axis, and the radiopaque markers can be positioned to indicate the periphery of the discrete body segments.

[0032] An exemplary clot retrieval device can include a first body segment and a second body segment, where the first body segment is positioned proximally relative to the second body segment. The outer expandable member can include two connecting arms joining the first body segment to the second body segment. Each of the two connecting arms can have a tapered shape that is wider near the proximal first body segment and narrower near the distal second body segment.

[0033] At least two of the four or more radiopaque markers may be aligned with respective ones of the two connecting arms along the longitudinal axis.

[0034] The outer expandable member can include two entry openings within the second framework, each of the two entry openings can include a respective opening bounded by the first body segment, the second body segment, and two connecting arms.

[0035] The first body segment can include four or more radiopaque markers forming a first set of markers, and the second body segment can include a second set of four or more radiopaque markers positioned to indicate the circumference of the second body segment. The radiopaque markers of the second set can be positioned such that when the clot retrieval device is in the collapsed configuration, each radiopaque marker of the second set is offset relative to a respective adjacent radiopaque marker of the second set with respect to the longitudinal axis of the device. Markers within the first set of radiopaque markers can be similarly offset.

[0036] The two connecting arms can be positioned approximately 180° from each other around the circumference of the outer expandable member. [Brief explanation of the drawings]

[0037] [Figure 1A]1 is an isometric view of an exemplary clot retrieval device, in accordance with aspects of the present invention. [Figure 1B] 1B shows an enlarged view of a portion of the clot retrieval device illustrated in FIG. 1A, the portion including tapered struts according to an embodiment of the present invention. [Figure 2A] 1B shows a plan view of a first side of the clot retrieval device illustrated in FIG. 1A. [Figure 2B] 2B shows a view of the clot retrieval device illustrated in FIG. 2A with the inner expandable member of the clot retrieval device removed from the view. [Figure 2C] 2B shows a view of the clot retrieval device illustrated in FIG. 2A with the outer expandable member of the clot retrieval device removed from the view. [Figure 3A] 2B shows a plan view of a second side of the clot retrieval device illustrated in FIG. 1A, the second side viewed at 90° from the first side view illustrated in FIG. 2A. [Figure 3B] 3B shows a view of the clot retrieval device illustrated in FIG. 3A with the inner expandable member of the clot retrieval device removed from the view. [Figure 3C] 3B shows a view of the clot retrieval device illustrated in FIG. 3A with the outer expandable member of the clot retrieval device removed from the view. [Figure 4A] 3C shows a line view of the outer expandable member of the clot retrieval device cut along the centerline shown in FIGS. 2B and 3B. FIG. [Figure 4B] 4B shows an enlarged view of a portion of the outer expandable member of the clot retrieval device shown in FIG. 4A. [Figure 4C] 4C shows an enlarged view of a portion of the outer expandable member of the clot retrieval device shown in FIG. 4B. [Figure 5A] 1B shows a plan view of the distal end of the clot retrieval device illustrated in FIG. 1A. [Figure 5B] 5B shows a view of the clot retrieval device illustrated in FIG. 5A with the inner expandable member of the clot retrieval device removed from the view. [Figure 5C] 5B shows a view of the clot retrieval device illustrated in FIG. 5A with the outer expandable member of the clot retrieval device removed from the view. [Figure 6A]1 illustrates an isometric view of another exemplary clot retrieval device, in accordance with aspects of the present invention. [Figure 6B] 6B shows an enlarged view of a portion of the clot retrieval device illustrated in FIG. 6A, the portion including tapered struts according to an embodiment of the present invention. [Figure 7A] 6B shows a plan view of a first side of the clot retrieval device illustrated in FIG. 6A. [Figure 7B] 7B shows a view of the clot retrieval device illustrated in FIG. 7A with the inner expandable member of the clot retrieval device removed from the view. [Figure 7C] 7B shows a view of the clot retrieval device illustrated in FIG. 7A with the outer expandable member of the clot retrieval device removed from the view. [Figure 8A] 7A shows a plan view of a second side of the clot retrieval device illustrated in FIG. 6A, the second side viewed at 90 degrees from the first side view illustrated in FIG. 7A. [Figure 8B] 8B shows a view of the clot retrieval device illustrated in FIG. 8A with the inner expandable member of the clot retrieval device removed from the view. [Figure 8C] 8B shows a view of the clot retrieval device illustrated in FIG. 8A with the outer expandable member of the clot retrieval device removed from the view. [Figure 9] 8C shows a line view of the outer expandable member of the clot retrieval device cut along the centerline shown in FIGS. 7B and 8B. [Figure 10A] 6B shows a plan view of the distal end of the clot retrieval device illustrated in FIG. 6A. [Figure 10B] 10B shows a view of the clot retrieval device illustrated in FIG. 10A with the inner expandable member of the clot retrieval device removed from the view. [Figure 10C] 10B shows a view of the clot retrieval device illustrated in FIG. 10A with the outer expandable member of the clot retrieval device removed from the view. [Figure 11A] 10 illustrates an exemplary outer expandable member traversing a lumen having a 360° bend, according to an embodiment of the present invention. [Figure 11B] FIG. 11B shows an enlarged view of a portion of the outer expandable member shown in FIG. 11A. [Figure 12A]1 shows a diagram of a portion of an exemplary expandable member having radiopaque markers in accordance with an aspect of the present invention. [Figure 12B] 12B shows a side view of a portion of the expandable member shown in FIG. 12A. [Figure 13A] 1 is an X-ray image of an exemplary clot retrieval device according to an embodiment of the present invention. [Figure 13B] 1 is an X-ray image of an exemplary clot retrieval device according to an embodiment of the present invention. [Figure 14] 10A-10C show views of an alternative distal portion of an exemplary clot retrieval device, in accordance with aspects of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0038] Specific embodiments of the present invention will now be described in detail with reference to the drawings, where like reference numbers indicate identical or functionally similar elements. The terms "distal" or "proximal" are used in the following description with reference to a location or direction relative to the treating physician. "Distal" or "distally" is a location away from the physician or a direction away from the physician. "Proximal" or "proximally" or "near" is a location closer to the physician or a direction toward the physician.

[0039] Accessing the cerebral, coronary, and pulmonary veins involves the use of numerous commercially available products and conventional procedural steps. Access products such as guidewires, guide catheters, angiographic catheters, and microcatheters are described elsewhere and are routinely used in catheterization procedures. In the following description, it is assumed that these products and methods are used in conjunction with the devices and methods of the present invention, and they need not be described in detail.

[0040] The following detailed description is merely exemplary in nature and is not intended to limit the invention or its application and uses. Although the invention is described mostly in the context of treating intracranial arteries, the invention may also be used in other body passageways as mentioned above.

[0041] 1A shows a distal portion of an exemplary clot retrieval device 100 in an expanded configuration. The clot retrieval device 100 generally extends defining a longitudinal axis AA and has a distal coil 108 at its distal end, an outer expandable member 102 and an inner expandable member 103 extending coaxially proximally from the distal coil 108, and a proximal coil 104 extending proximally from the outer expandable member 102 and the inner expandable member 103. The device 100 may include additional features such as an elongate shaft 106, a sleeve 105, and an indicator band 107. The device 100 may include a distal joint or collar 109 joining the distal coil 108 to the outer expandable member 102 and the inner expandable member 103. The device 100 may include a proximal joint or collar 112 joining the proximal coil 104 to the outer expandable member 102 and the inner expandable member 103. The joints 109, 112 can be constructed to be usable with a clot retrieval device having two expandable layers 102, 103, such as described in U.S. Pat. No. 10,390,850, which is incorporated by reference herein as if fully set forth herein.

[0042] FIG. 1B shows an enlarged view of a portion of the clot retrieval device illustrated in FIG. 1A, the portion including tapered struts according to an embodiment of the present invention.

[0043] FIG. 2A shows a plan view of a first side of the clot retrieval device 100. FIG. 2B shows a view of the clot retrieval device 100 illustrated in FIG. 2A with the inner expandable member 103 removed for illustrative purposes. FIG. 2C shows a view of the clot retrieval device 100 illustrated in FIG. 2A with the outer expandable member 102 removed for illustrative purposes. FIG. 3A shows a plan view of a second side of the clot retrieval device 100, the second side being viewed 90 degrees from the first side view illustrated in FIG. 2A. FIG. 3B shows a view of the clot retrieval device 100 illustrated in FIG. 3A with the inner expandable member 103 removed for illustrative purposes. FIG. 3C shows a view of the clot retrieval device 100 illustrated in FIG. 3A with the outer expandable member 102 removed for illustrative purposes. FIG. 4A shows a line view of the outer expandable member 102 cut and flattened along line BB shown in FIGS. 2B and 3B. Figure 4B shows an enlarged view of a portion of the outer expandable member 102 shown in Figure 4A. Figure 4C shows an enlarged view of a portion of the outer expandable member 102 shown in Figure 4B. Figure 5A shows a plan view of the distal end of the clot retrieval device 100. Figure 5B shows a view of the clot retrieval device 100 illustrated in Figure 5A with the inner expandable member 103 removed for illustrative purposes. Figure 5C shows a view of the clot retrieval device 100 illustrated in Figure 5A with the outer expandable member 102 removed for illustrative purposes.

[0044] 1B and 4C , the outer expandable member 102 can include tapered struts 129, 130 joining the body segments 126, 127, 128. The tapered struts 129, 130 are shaped to impart flexibility to the outer expandable member 102, facilitating withdrawal of the device 100 from a tortuous vessel when an obstruction is at least partially trapped by the outer expandable member 102. Additionally or alternatively, the tapered struts 129, 130 are shaped to promote circumferential apposition of the outer expandable member 102 to the vessel wall as the device 100 is withdrawn through tortuous vasculature when an obstruction is at least partially trapped by the outer expandable member 102.

[0045] As described in more detail with respect to Figures 4A and 4B, the outer expandable member 103 can include staggered radiopaque markers positioned to facilitate visualization of the device 100 during the procedure, while also maintaining the low-profile folded configuration of the outer expandable member 102 to facilitate traversing the folded device 100 across a clot or other obstruction.

[0046] 1A-5C collectively, the outer expandable member 102 and the inner expandable member 103 are collapsible within a constraining sheath (e.g., a microcatheter) sized to cross a clot or other obstruction. The outer expandable member 102 and the inner expandable member 103 are each configured to self-expand upon release from the constraining sheath. In the expanded configuration, the device 100 can facilitate clot retrieval, flow restoration, and / or tear protection.

[0047] Both the inner and outer expandable members 102 and 103 are preferably made from materials that can automatically recover their shape upon release from a contracted delivery configuration. Superelastic or pseudoelastic materials, such as nitinol or alloys with similar properties, are particularly suitable. The material can have a high recoverable strain sufficient to elastically collapse and expand as described herein. The material can be in many forms, such as wire, strip, sheet, or tube. A particularly suitable manufacturing process is to laser cut a nitinol tube, then heat treat and electropolish the resulting structure to create a framework of struts and connecting elements. This framework can be in any of a vast range of shapes, as will be understood by those skilled in the relevant art in light of the teachings disclosed herein. The framework can be visualized under fluoroscopy by the addition of alloying elements or through various other coatings or marker bands. For example, the framework can include materials and / or markers with radiopaque materials, including, but not limited to, barium sulfate, bismuth subcarbonate, barium oxychloride, gold, tungsten, platinum, iridium, tantalum, and alloys thereof. Specifically, in some embodiments, the framework can include radiopaque markers comprising an iridium alloy, more specifically a platinum-iridium alloy.

[0048] The inner expandable member 103 is preferably configured to expand to a diameter D2 that is smaller than the diameter of the smallest blood vessel in which it is intended to be used, which diameter D2 is typically less than 50% of the diameter D1 of the outer expandable member 102 and may be 20% or less of the outer member diameter D1.

[0049] The distal scaffolding zone can incorporate strut elements from the framework of the outer and / or inner expandable member 102, 103, such as the expanded portion 110 of the inner expandable member 103 and the distal portion 128 of the outer expandable member 102. The strut shapes of the distal scaffolding zone can be shaped as illustrated herein or as described in connection with compatible stent-like clot retrievers, such as those disclosed in U.S. Pat. No. 10,390,850. The distal scaffolding zone can further include thin wires or fibers to provide additional scaffolding while minimally impacting the overall device profile or deliverability. Suitable materials, such as polymeric materials such as UHMWPE, aramid, LCP, PET, or PEN, or metals such as tungsten, MP35N, stainless steel, or nitinol, ideally have high tensile strength, thereby allowing for the production of very thin wires or fibers with sufficient integrity for manufacturability and use.

[0050] In each of the expanded and collapsed configurations, the inner expandable member 103 and the outer expandable member define respective tubular bodies. Preferably, the tubular bodies are coaxial about a longitudinal axis AA. The device 100 includes a receiving space 111 within the outer expandable member 102 and outside the inner expandable member 103 when the inner and outer expandable members 102, 103 are in the expanded configuration. The device 100 and the receiving space 111 are sized, shaped, and otherwise configured to allow a clot to be at least partially trapped within the receiving space during a clot removal procedure. The interior of the inner expandable member 103 when expanded is configured to provide a flow path through which blood can flow when the device 100 is expanded through a clot.

[0051] During a clot removal procedure, the length of the outer expandable member 102 can be approximately the same length as or longer than the length of the occluding clot, eliminating many of the degrees of freedom of movement available to the clot. The outer member 102 includes sized and shaped entrance openings 222 and is otherwise configured to provide the primary degrees of freedom of movement available to the clot, such that expansion of the outer member 102 forces the clot into the receiving space 111. The outer member 102 has multiple entrance openings 122 for receiving the clot. In this manner, the entrance openings 122 allow portions of the clot to enter the receiving space 111 of the outer member 102, thereby allowing the clot to be retrieved without being overly compressed. This is advantageous because the inventors have discovered that compressing a clot causes dehydration, which increases the frictional properties of the clot and makes it more rigid, making it more difficult to dislodge and remove from the blood vessel. This compression can be avoided if the clot migrates inward through the scaffolding of the outer member 102 as the scaffolding migrates outward toward the vessel wall.

[0052] The inlet opening 122 can further allow for the application of a force to the clot in a direction substantially parallel to the direction in which the clot is withdrawn from the blood vessel (i.e., substantially parallel to the central axis of the blood vessel) when the outer member 102 is retracted. This means that the outward radial force applied to the vasculature can be kept to a minimum, which in turn means that the action applied to the clot by the clot retrieval 100 does not increase the force required to remove the clot from the vessel, thus protecting the delicate cerebral vessels from harmful radial and tensile forces.

[0053] The outer expandable member 102 includes proximal struts 120 connected at a proximal end to the proximal collar 112 and at a distal end to a proximal body segment 126. The proximal struts 120 may have a tapered profile or be otherwise configured to provide a gradual transition in stiffness from the shaft 106 to the tubular body of the outer expandable member 102.

[0054] Proximal body segment 126 is connected to intermediate body segment 127 by two connecting arms 129 that extend from proximal junction 139 to distal junction 140. Intermediate body segment 127 is connected to distal body segment 128 by two connecting arms 130 that extend from proximal junction 141 to distal junction 142. The region between intermediate body segment 127 and distal body segment 128 includes two inlet openings 122 through which a clot can pass into receiving space 111 defined by the region between inner member 102 and outer member 103.

[0055] 1B and 4C , each of the connecting arms 129 can have a tapered profile, with a width that tapers from a wide dimension W1 at the respective proximal junction 139, 141 to a narrow dimension W2 near the respective distal junction 140, 142. At the distal junctions 140, 142, the connecting arms 129, 130 can expand to a width W3 that is wider than the narrow width W2 to accommodate the diverging distal struts 170. The connecting arms 129, 130 can have a substantially uniform height H (thickness). The height H can correspond to the majority of the strut thickness of the outer expandable member 102.

[0056] 1B and 4C, approximate values ​​for the labeled dimensions are as follows: height H has a value of approximately 0.075 mm, proximal strut width W1 has a value of approximately 0.16 mm, distal strut width W2 has a value of approximately 0.08 mm, and bifurcation strut width W3 has a value of approximately 0.20 mm. Thus, the approximate percentage change in width between proximal width W1 and distal width W2 is a 50% decrease, and the approximate percentage change in width between distal width W2 and bifurcation width W3 is a 60% increase.

[0057] The tapered shape of connecting arms 129, 130 can be configured to bend to reduce pullout forces around a vessel bend compared to a similarly constructed stent-like clot retriever device with non-tapered connecting arms. Arms 129, 130 can be configured to bend at a curvature that has a larger curvature (smaller radius of curvature) compared to the majority of struts within outer expandable member 102. (See radius r shown in FIG. 11B.)

[0058] The connecting arm 129 between the proximal body segment 126 and the intermediate body segment 127 of the outer expandable member 102 can be substantially aligned with the connecting arm 130 between the intermediate body segment 127 and the distal body segment 128 during bending to align the neutral axes of the body segments 126, 127, 128. In another embodiment, the connecting arm 129 between the proximal body segment 126 and the intermediate body segment 127 can be aligned at an angle, such as 90°, relative to the connecting arm 130 between the intermediate body segment 127 and the distal body segment 128.

[0059] 2B and 3B, proximal body segment 126 includes interconnected struts, with certain struts, such as strut 143, terminating at distal apex 133 without a distal connecting element, and other struts, such as 144, terminating at junction points 145, 146. Intermediate body segment 127 includes interconnected struts, with certain struts, such as strut 147, terminating at distal apex 134 without a distal connecting element, and other struts, such as strut 148, terminating at junction point 171.

[0060] One or more of the body segments 126, 127, 128 can include marker bands or radiopaque features, such as gold or platinum markers or coils. In the illustrated embodiment, elliptical markers 121, 125 are shown secured to eyelets on the struts of the proximal, intermediate, and distal body segments 126, 127, 128. The marker 125 on the distal body segment 128 can be positioned to indicate to a user the location of the distal body segment 128, and therefore the location of the distal portion of the device 100, to aid in the accuracy of deployment of the device 100. The distal body segment 128 can include a single marker 125 indicating the location of the distal body segment 128, or multiple markers indicating the circumference of the distal body segment 128. Each of the proximal and intermediate body segments 126, 127 may include a plurality of oval markers 121 positioned circumferentially around the respective body segment 126, 127 to indicate to a user the expanded circumference C1 and / or position of the respective body segment 126, 127 during a procedure (where circumference C1 is diameter D1 multiplied by pi). In the illustrated embodiment, the proximal body segment 126 and intermediate body segment 127 each include four markers 121 positioned approximately equidistantly around the circumference C1 of the outer expandable member 102.

[0061] 4A and 4B show the outer expandable member 102 cut along line BB as shown in FIGS. 2B and 3B, laid flat, and folded to a height C2 corresponding to the circumference of the outer expandable member 102 when the device 100 is constrained by a microcatheter or sheath. As shown in more detail in FIG. 4B , the markers 121 on each of the proximal body segment 126 and the intermediate body segment 127 are staggered and offset along the longitudinal axis AA (i.e., positioned at different distances from the proximal collar 112) to facilitate folding to height C (circumference) of the outer expandable member 102. Each respective marker 121 connects to an elongated segment 172 shaped to nest adjacent markers 121 between a junction (e.g., junction 141) and the respective connecting marker 121. The elongated segments 172 and markers 121 are positioned alternately in the circumferential direction.

[0062] The posts within body segments 126, 127, 128 can be configured so that the crowns or joints (e.g., joints 145 and 150, and other similarly shaped joints) are not aligned the same distance from the proximal collar during insertion. Because it generally requires more force to insert the joints (crowns) into the sheath than the posts during insertion or resheathing, the user may experience increased insertion forces when multiple crowns are inserted simultaneously. By making alternate posts 144 and 151 different lengths and offsetting the crowns, insertion forces may be reduced, providing an improved perception to the user.

[0063] The distal end of the distal body segment 128 includes struts that form a tapered shape that terminates at a distal junction 109, thus defining a closed end distal to the outer member 102. The distal body segment 128 is shown as viewed from the distal end of the device 100 in a plan view in FIG. 5A , with the inner expandable member 103 removed for illustrative purposes in FIG. 5B and the outer expandable member 102 removed for illustrative purposes in FIG. 5C. The distal end of the distal body segment 128 can include a distal framework illustrated herein or an alternative distal framework usable with a stent-like clot retriever device. The tapered portion of the distal body segment 128 can be shaped or otherwise configured to prevent the escape of clots or clot fragments that have entered the receiving space 111 between the inner member 102 and the outer member 103. The extended distal struts 110 of the inner member 103, in combination with the closed distal end of the outer member 102, act as an additional three-dimensional filter to further prevent the escape of clots or clot fragments. In certain embodiments, this distal section may include fiber attachment points, such as eyelets or other fiber attachment mechanisms, and fibers can be connected to the distal section at these attachment points to create a distal net.

[0064] As shown in more detail in FIGS. 2C, 3C, and 5C, the inner expandable member 103 is configured to self-expand upon release from a constraining sheath (e.g., a microcatheter) to a diameter D2 that is larger than the expanded diameter D1 of the outer expandable member 102 and smaller than the diameter of the blood vessel that the device 100 is configured to treat. The inner tubular member 103 comprises a denser scaffold with smaller openings compared to the outer expandable member 102. The inner tubular member 103 is configured to provide a flow lumen through the device 100 to facilitate immediate restoration of blood flow through the clot upon deployment. Additionally or alternatively, the inner tubular member 103 is configured to scaffold the flow lumen through the clot to prevent release of fragments that might otherwise lodge in the distal vasculature. The inner tubular member 103 includes connecting struts 131 that may contact the clot when initially deployed within a target vessel within the clot. The struts 131 of the inner tubular member 103 contact the clot, providing additional gripping force and aiding in the initial removal of the clot from the vessel as the device is retracted.

[0065] The inner expandable member 103 comprises a generally cylindrical section of interconnected struts 131 that is connected at its proximal end by strut 138 (or struts) to a proximal junction 112. The distal end of the inner expandable member 103 includes an expansion section formed from expanded struts 110 that have a diameter greater than the diameter D2 of the body section of the inner tubular member 103. These expanded struts 110 are connected to coil sections 118 that, in this embodiment, are laser cut from a tube during which the inner expandable member 103 is also cut.

[0066] The shaft 106 can include a tapered wire shaft and may be made from stainless steel, MP35N, Nitinol, or other materials with a suitably high modulus and tensile strength. The shaft 106 can have indicator bands 107 on the shaft to indicate to the user when the distal end of the device is approaching the end of the microcatheter during insertion. These bands are positioned to indicate that the distal tip of the device is approaching the end of the microcatheter when approaching the microcatheter hub or hemostasis valve. These indicator bands can be formed by printing, removing, or masking areas of the shaft coating so that they are visually distinct from the rest of the shaft. The indicator bands 107 can also be recessed below the surface of the shaft 106 to provide tactile feedback to the user when approaching the microcatheter.

[0067] The proximal coil 104 can extend from the distal portion of the shaft 106. The coil of the proximal coil 104 can be metallic, such as stainless steel, or a more radiopaque material, such as platinum or gold, or an alloy of such materials. Additionally or alternatively, the coil can be coated with a low-friction material, or a polymer jacket can be positioned on the outer surface of the coil. A sleeve 105 can be positioned on the shaft 106 adjacent to the coil 104. The sleeve 105 can include a polymer material and can be positioned in a tapered section of the shaft. The sleeve 105 can be made radiopaque by adding a filler material, such as tungsten or barium sulfate. The sleeve 105 and shaft 106 can be coated with a material to reduce friction and thrombogenicity. The coating can be composed of a low-friction lubricant, such as a polymer, silicone, hydrophilic, or hydrophobic coating. This coating can also be applied to the outer member 102 and inner tubular member 103.

[0068] The outer member 102 and inner tubular member 103 can be joined at a proximal junction 112 and a distal junction 109 during assembly. To minimize tension within the members 102, 103 during use, the length of the outer member 102 can be substantially the same as the length of the inner member 103 in its freely expanded and collapsed, deployed configurations. The expanded struts 110 of the inner tubular member 103 elongate during deployment, resulting in equal lengths of the inner and outer members when fully deployed within the microcatheter. A length difference between the inner and outer members 103 may still occur when the device is deployed in a small vessel or during the deployment or deployment process. The coil 118 at the distal end of the inner tubular member 103 can accommodate slight length differences by stretching without applying significant tensile or compressive forces to the device. In another embodiment, the coil 118 may be formed separately from the inner tubular member 103 and then assembled to it. The coil 118 can be formed from a stainless steel material, a polymer, or from a more radiopaque metal such as gold or platinum or an alloy of such materials. The coil 118 can also be replaced with a longitudinal length of elastic material such as a low modulus polymer or elastomer.

[0069] In other embodiments, the inner member 103 may not be connected to the distal end of the outer member 102 at all, or may be constrained within the outer member 102 without being fixedly attached. In other embodiments, the inner member 103 may have a non-cylindrical cross-section, may be of non-uniform diameter, or may have a tailored strut pattern to provide regions of different radial forces or flexibility.

[0070] FIG. 6A shows an isometric view of another example clot retrieval device 200. Compared to the device 100 shown in FIGS. 1A-5D, the outer expandable member 202 of the clot retrieval device 200 illustrated in FIG. 6A includes multiple intermediate body segments 227 rather than a single intermediate body segment 127. At least the proximal body segment 226 and the intermediate body segment 227 each include interconnected struts, with certain struts terminating at distal apexes 233 lacking distal connecting elements and other struts terminating at junctions. The device 200 shown in FIG. 6A includes three intermediate body segments 227. In accordance with the present invention, clot retrieval devices incorporating the features described and illustrated herein can include one, two, three, four, five, or more intermediate body segments. The device 200 includes an elongated inner expandable member 203 to accommodate the additional intermediate body segments 227 of the outer expandable member 202.

[0071] The device 200 can include a receiving space 211 between the outer expandable member 202 and the inner expandable member 203 configured similarly to the receiving space 111 of the device 100 shown in FIGS. 1A-5C.

[0072] Device 200 may further include a proximal coil 204, a distal coil 208, a distal junction 209, and a proximal junction 212 constructed similarly to corresponding components 104, 208, 209, 212 shown in Figures 1A-5D. Device 200 may further include a sleeve, a shaft, and an indicator band constructed similarly to corresponding components 105, 106, 107 shown in Figure 1A.

[0073] Figure 6B shows an enlarged view of a portion of the clot retrieval device 200 illustrated in Figure 6A, including a tapered connecting arm 230. The connecting arm 230 may be shaped as shown and described in connection with the tapered connecting arms 129, 130 of the device 100 shown in Figures 1A-5C. The connecting arm 230 may join the proximal, intermediate, and distal body segments 226, 227, 228 and may otherwise be configured in a manner similar to the connecting arms 129, 130 of the device 100 shown in Figures 1A-5C.

[0074] Figure 7A shows a plan view of a first side of clot retrieval device 200. Figure 7B shows a view of clot retrieval device 200 shown in Figure 7A with inner expandable member 203 removed for illustrative purposes. Figure 7C shows a view of clot retrieval device 200 shown in Figure 7A with outer expandable member 202 removed for illustrative purposes.

[0075] The outer expandable member 202 of the device 200 can include proximal struts 220 and a proximal body segment 226 constructed similarly to the proximal struts 120 and proximal body segment 126 of the device 100 shown in Figures 1A-5C. The outer expandable member 202 can include a distal body segment 228 constructed similarly to the distal body segment 128 of the device 100 shown in Figures 1A-5C. The outer expandable member 202 can include otherwise configured radiopaque markers 216, 221, 225 located at corresponding markers 116, 121, 125 of the device 100 shown in Figures 1A-5C. The outer expandable member 202 can include an inlet opening 222 configured similarly to the inlet opening 122 of the device 100 shown in Figures 1A-5C.

[0076] The inner expandable member 203 can include distal crown struts 210 interconnecting the struts 231 of the tubular body portion and proximal connecting struts 234 similar to the corresponding struts 110, 131, 138 of the device 100 shown in Figures 1A-5C. The inner expandable member 203 can be connected to an inner coil 218 configured similarly to the inner coil 118 of the device 100 shown in Figures 1A-5C.

[0077] Figure 8A shows a plan view of a second side of the clot retrieval device illustrated in Figure 6A, the second side being viewed at 90 degrees from the first side view illustrated in Figure 7A. Figure 8B shows a view of clot retrieval device 200 shown in Figure 8A with inner expandable member 203 removed for illustrative purposes. Figure 8C shows a view of clot retrieval device 200 shown in Figure 8A with inner expandable member 202 removed for illustrative purposes.

[0078] Figure 9 shows a line view of the outer expandable member 202 cut along the centerline BB shown in Figures 7B and 8B. The portion of the outer expandable member 202 shown in Figure 9 can be configured as shown in Figure 4B and further shown in Figure 4C. For example, the radiopaque markers 221 can be staggered, as shown in more detail in Figure 4B. The connecting arms 230 can be tapered or otherwise configured as the arms 129 illustrated in more detail in Figures 4B and 4C. The struts and joints of the outer expandable member 202 can be shaped or otherwise configured to correspond to the joints and struts 144, 145, 146, 147, 150, 151 shown in Figures 4B and 4C.

[0079] Figure 10A shows a plan view of the distal end of clot retrieval device 200. Figure 10B shows a view of clot retrieval device 200 illustrated in Figure 10A with inner expandable member 203 removed for illustrative purposes. Figure 10C shows a view of clot retrieval device 200 illustrated in Figure 10A with outer expandable member 202 removed for illustrative purposes.

[0080] FIG. 11A shows an exemplary outer expandable member 302 traversing a lumen having a 360° bend with a radius of curvature rB at the apex of the bend. Because the outer expandable member 302 closely follows the bend of the lumen, the outer expandable member has a radius of curvature approximately equal to the radius of curvature rB of the lumen. FIG. 11B shows an enlarged view of a portion of the outer expandable member 302 shown in FIG. 11A. The outer expandable member 302 includes tapered connecting arms 330 between body segments 327 configured similarly to the connecting arms 129, 130, 230 of the devices 100, 200 shown in FIGS. 1A-10C. As shown in more detail in FIG. 11B, the outer expandable member 302 has a curvature with a radius rA in a narrow area of ​​the connecting arms 330, which curvature is smaller than the radius of curvature rB of the outer expandable member 302 around the bend of the lumen. In other words, the connecting arms 330 provide a bending point for the outer expandable member 302. The flexibility of the connecting arms 330 allows the body segment 327 to extend in apposition to a lumen (e.g., the illustrated lumen and / or the vascular lumen) to a greater extent than a similarly constructed outer expandable member having less flexible connecting arms. In one example, the outer expandable member 302 can be configured to bend with a curvature having a radius rA at the narrow area of ​​the connecting arms 330 of approximately 0.5 millimeters (mm) or greater, including 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, and 1.0 mm.

[0081] Figure 12A shows a diagram of a portion of an exemplary expandable member having radiopaque markers. Figure 12B shows a side view of the portion of the expandable member shown in Figure 12A. Some or all of the markers 116, 121, 125, 216, 221, 225 of the devices shown and described herein can be shaped similarly to the markers shown in Figures 12A and 12B.

[0082] 13A and 13B are x-ray images of an exemplary clot retrieval device according to an embodiment of the present invention. The radiopaque material in the distal coil, the proximal coil, and the markers appear dark in the x-ray image.

[0083] The clot retrieval devices according to the teachings herein can be sized to accommodate various procedural needs. Dimensions such as the overall length L1 of the outer expandable member, the working length L2 of the device, the diameter D1 of the outer expandable member D1, and the diameter D2 of the inner expandable member can be measured, as shown in Figures 2A-2C and 7A-7C.

[0084] In one exemplary device, when freely expanded, the outer expandable member can have a total length L1 of about 34 mm, a working length L2 of about 22 mm, and a diameter D1 of about 5 mm. The inner expandable member tubular body diameter D2 is less than the outer expandable member diameter, preferably about 1 mm, and more preferably about 1.22 mm. An exemplary device so configured may be suitable for treating blood vessels having diameters from about 1.5 mm to about 5 mm. The outer expandable member of the exemplary device preferably includes a proximal body segment, exactly one intermediate body segment, and a distal body segment, similar to the proximal body segment 126, intermediate body segment 127, and distal body segment 128 of device 100 shown in FIGS. 1A-5C.

[0085] In another exemplary device, when freely expanded, the outer expandable member can have a total length L1 of about 49 mm, a working length L2 of about 37 mm, and a diameter D1 of about 5 mm. The inner expandable member tubular body diameter D2 is less than the outer expandable member diameter, preferably about 1 mm, and more preferably about 1.22 mm. The exemplary device can be suitable for treating blood vessels having diameters from about 1.5 mm to about 5 mm. The outer expandable member of the exemplary device preferably includes a proximal body segment, exactly three intermediate body segments, and a distal body segment similar to the proximal body segment 226, intermediate body segment 227, and distal body segment 228 of device 200 shown in FIGS. 6A-10C.

[0086] In another exemplary device, when freely expanded, the outer expandable member can have a total length L1 of about 57 mm, a working length L2 of about 45 mm, and a diameter D1 of about 6.5 mm. The inner expandable member tubular body diameter D2 is less than the outer expandable member diameter, preferably about 1 mm, and more preferably about 1.22 mm. The exemplary device can be suitable for treating blood vessels having diameters from about 1.5 mm to about 6.5 mm. The outer expandable member of the exemplary device preferably includes a proximal body segment, exactly three intermediate body segments, and a distal body segment similar to the proximal body segment 226, intermediate body segment 227, and distal body segment 228 of device 200 shown in FIGS. 6A-10C.

[0087] In some examples, a clot retrieval device according to the teachings herein can be dimensioned such that the markers on the body segments illustrated herein (e.g., markers 121, 221 on body segments 126, 127, 128, 226, 227, 228 illustrated herein) can be spaced longitudinally (along the longitudinal axis AA) about 10 mm from one or more markers on an adjacent body segment when the clot retrieval device is collapsed for delivery across a clot, and can be spaced longitudinally about 8 mm when the clot retrieval device is freely expanded.

[0088] FIG. 14 shows an alternative distal portion of an exemplary clot retrieval device, which is described in more detail in U.S. non-provisional patent application entitled "A CLOT RETRIEVAL DEVICE FOR REMOVING CLOT FROM A BLOOD VESSEL," filed concurrently herewith and incorporated by reference as if set forth in its entirety herein.

[0089] In some examples, a clot retrieval device according to the teachings herein can have alternative geometries suitable for the clot retrieval device. For example, the clot retrieval device can include a distal portion configured as shown in FIG. 14. The outer expandable member can include a distal body portion configured similar to distal body portion 328 shown in FIG. 14. Alternatively, the distal portion of the clot retrieval device need not be configured to capture clot fragments and may, for example, have large cell openings or be completely open. Furthermore, in some examples, the clot retrieval device need not include an inner body.

[0090] As discussed herein, a "patient" or "subject" can be a human or any animal. It should be understood that the animal can be of any of a variety of applicable types, including, but not limited to, mammals, veterinary animals, livestock animals, or pet animals. As an example, the animal can be a laboratory animal (e.g., rats, dogs, pigs, monkeys, etc.) specifically selected to have certain characteristics similar to humans.

[0091] The terms "about" or "approximately," as used herein in connection with any numerical value or range of values, indicate a suitable dimensional tolerance that enables a portion of a component or a collection of components to function according to its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of values ​​of ±20% of the recited value; for example, "about 90%" may refer to a range of values ​​of 71% to 99%. Ranges may be expressed herein as "about" or "approximately" one particular value to "about" or "approximately" another particular value. When such a range is expressed, other exemplary embodiments also include from one particular value to the other particular value.

[0092] "Comprising" or "containing" or "including" means that at least the specified compounds, elements, particles, or method steps are present in a composition or article or method, but does not exclude the presence of other such compounds, elements, particles, or method steps, even if they have the same function as the specified ones.

[0093] It should also be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0094] In describing the embodiments, technical terms are used for clarity. Each term is intended to have its broadest meaning as understood by one of ordinary skill in the art and is intended to include all technical equivalents that operate in a similar manner to accomplish a similar purpose. It should also be understood that a reference to one or more steps of a method does not preclude the presence of additional or intervening method steps between those explicitly identified steps. It should also be understood that the method steps may be performed in a different order than described herein without departing from the scope of the disclosed technology. Similarly, it should also be understood that a reference to one or more components in a device or system does not preclude the presence of additional or intervening components between those explicitly identified components.

[0095] The descriptions contained herein are examples of the present disclosure and are not intended to limit the scope of the present disclosure in any way. While specific embodiments of the present disclosure have been described, various modifications to the devices and methods can be made without departing from the scope and spirit of the present disclosure. For example, while the embodiments described herein refer to specific components, the present disclosure includes other embodiments that utilize combinations of various components to achieve the described functionality, utilize alternative materials to achieve the described functionality, combine components from various embodiments, combine components from various embodiments with known components, and the like. The present disclosure contemplates the substitution of other known, commercially available products for the component parts illustrated herein. The following claims are intended to include modifications that would be apparent to those skilled in the art as understood in accordance with the teachings herein.

[0096] [Embodiment] (1) A clot retrieval device configured to remove a blood clot from a blood vessel, the device having a collapsed configuration and an expanded configuration, the device comprising: an inner expandable member comprising a first framework of struts; an outer expandable member forming closed cells that are larger than the closed cells of the inner expandable member and comprising a second framework of struts that at least partially radially surrounds the inner expandable member; the outer expandable member comprises a first body segment and a second body segment connected by two connecting arms; the first body segment is positioned proximally relative to the second body segment; each of the two connecting arms having a tapered shape that is wider adjacent the first body segment and narrower adjacent the second body segment, Clot retrieval device. (2) A clot retrieval device as described in embodiment 1, wherein the outer expandable member has two entrance openings within the second framework, each of the two entrance openings having a respective opening bounded by the first body segment, the second body segment, and the two connecting arms. (3) A clot retrieval device as described in embodiment 2, wherein the first body segment has two pairs of struts, each strut terminating at a respective distal apex and forming a proximal boundary of each of the two entrance openings. (4) A clot retrieval device as described in embodiment 1, wherein the two connecting arms extend substantially parallel to the longitudinal axis of the device. (5) A clot retrieval device as described in embodiment 1, wherein the two connecting arms are positioned approximately 180° from each other around the circumference of the outer expandable member.

[0097] (6) A blood clot retrieval device as described in embodiment 1, wherein the first body segment and the second body segment are connected to each other only via the two connecting arms. (7) The clot retrieval device of claim 1, wherein each of the two connecting arms is configured to bend at a curvature having a radius smaller than the radius of curvature of a majority of the struts of the first and second body segments when the clot retrieval device is pulled proximally through a tubular vasculature having an approximately 180° bend. This smaller radius of curvature can have a range of values ​​depending on the tortuosity of the vasculature in which the device is expanded, with a value approximately equal to 0 mm when the device is in a straight vessel and approximately equal to 0.5 mm when the device is in a vessel having a 180° bend. (8) the outer expandable member comprises three or more body segments, each shaped substantially similarly to the first body segment and the second body segment; A clot retrieval device as described in embodiment 1, wherein the outer expandable member has a pair of tapered connecting arms, whereby each respective pair of tapered connecting arms joins longitudinally adjacent body segments of the three or more body segments. (9) at least one of the first body segment and the second body segment comprises four or more radiopaque markers positioned around the circumference of the respective body segment; A clot retrieval device as described in embodiment 1, wherein when the clot retrieval device is in the folded configuration, each of the radiopaque markers is offset relative to each adjacent radiopaque marker among the four or more radiopaque markers with respect to the longitudinal axis of the device. (10) A clot retrieval device as described in embodiment 9, wherein, when the clot retrieval device is in the folded configuration, alternating radiopaque markers among the four or more radiopaque markers are aligned in a plane perpendicular to the longitudinal axis.

[0098] (11) The first body segment comprises a first set of four or more radiopaque markers; the second body segment comprises a second set of four or more radiopaque markers; when the clot retrieval device is in the expanded configuration, the first set of four or more radiopaque markers and the second set of four or more radiopaque markers are spaced apart approximately 8 millimeters as measured along the longitudinal axis; A clot retrieval device as described in embodiment 9, wherein when the clot retrieval device is in the folded configuration, the first set of four or more radiopaque markers and the second set of four or more radiopaque markers are spaced approximately 10 millimeters apart measured in the direction of the longitudinal axis. (12) A clot retrieval device as described in embodiment 9, wherein each of the four or more radiopaque markers comprises a radiopaque material positioned within an eyelet. (13) A clot retrieval device as described in embodiment 9, wherein at least two of the four or more radiopaque markers are aligned with respective connecting arms of the two connecting arms in the direction of the longitudinal axis. (14) A clot retrieval device configured to remove a blood clot from a blood vessel, the clot retrieval device having a collapsed configuration and an expanded configuration, the clot retrieval device comprising: an inner expandable member comprising a first framework of struts; an outer expandable member, a second framework of struts forming closed cells larger than the closed cells of the inner expandable member and at least partially radially surrounding the inner expandable member; a clot retrieval device comprising an outer expandable member comprising four or more radiopaque markers attached to a second framework of the struts and positioned to indicate the circumference of the outer expandable member, and further positioned such that when the clot retrieval device is in the folded configuration, each of the radiopaque markers is offset relative to a respective circumferentially adjacent radiopaque marker of the four or more radiopaque markers with respect to the longitudinal axis of the device. (15) The outer expandable member comprises discontinuous body segments spaced apart along the longitudinal axis; A clot retrieval device as described in embodiment 14, wherein the four or more radiopaque markers are positioned to indicate the outer periphery of a body segment among the discontinuous body segments.

[0099] (16) The body segments include a first body segment and a second body segment, the first body segment being positioned proximally relative to the second body segment; the outer expandable member comprises two connecting arms joining the first body segment to the second body segment; A clot retrieval device as described in embodiment 15, wherein each of the two connecting arms has a tapered shape that becomes wider adjacent to the first body segment and narrower adjacent to the second body segment. (17) A clot retrieval device as described in embodiment 16, wherein at least two of the four or more radiopaque markers are aligned with respective connecting arms of the two connecting arms in the direction of the longitudinal axis. (18) The clot retrieval device of embodiment 16, wherein the outer expandable member has two entrance openings within the second framework, each of the two entrance openings having a respective opening bounded by the first body segment, the second body segment, and the two connecting arms. (19) The first body segment includes the four or more radiopaque markers forming a first set of markers; A clot retrieval device as described in embodiment 16, wherein the second body segment comprises a second set of four or more radiopaque markers, the second set of four or more radiopaque markers being positioned to indicate the outer periphery of the second body segment, and further wherein when the clot retrieval device is in the folded configuration, each of the radiopaque markers of the second set is positioned offset relative to each adjacent radiopaque marker of the second set with respect to the longitudinal axis of the device. (20) The clot retrieval device of embodiment 16, wherein the two connecting arms are positioned approximately 180° from each other around the circumference of the outer expandable member.

Claims

1. 1. A clot retrieval device configured to remove a blood clot from a blood vessel, the device having a collapsed configuration and an expanded configuration, the device comprising: an inner expandable member comprising a first framework of struts; an outer expandable member forming closed cells that are larger than the closed cells of the inner expandable member and comprising a second framework of struts that at least partially radially surrounds the inner expandable member; the outer expandable member comprises a first body segment and a second body segment connected by two connecting arms; the first body segment is positioned proximally relative to the second body segment; each of the two connecting arms has a tapered shape that is wider adjacent the first body segment and narrower adjacent the second body segment, a proximal end of the inner expandable member and a proximal end of the outer expandable member joined at a proximal junction, and a distal end of the inner expandable member and a distal end of the outer expandable member joined at a distal junction; a distal portion of the outer expandable member forms a tapered shape terminating at the distal junction, the inner expandable member having an expansion section located distal to the first framework of the struts, the expansion section having a diameter greater than a diameter of the first framework of the struts in an expanded configuration of the inner expandable member; the second body segment comprising four or more radiopaque markers positioned about a circumference of the second body segment; when the clot retrieval device is in the collapsed configuration, each of the four or more radiopaque markers is offset in a direction extending along a longitudinal axis of the clot retrieval device relative to a circumferentially adjacent radiopaque marker of the second body segment; an elongated segment is connected to a proximal end of a second radiopaque marker that is adjacent to a first radiopaque marker of the four or more radiopaque markers in the circumferential direction of the second body segment, and the first radiopaque marker and the elongated segment are located at the same position in the direction in which the longitudinal axis extends; A blood clot retrieval device, wherein a width of each of the four or more radiopaque markers in the circumferential direction of the second body segment is greater than a width of the elongated segment in the circumferential direction of the second body segment.

2. 2. The clot retrieval device of claim 1, wherein the outer expandable member comprises two entrance openings within the second framework of the struts, each of the two entrance openings comprising a respective opening bounded by the first body segment, the second body segment, and the two connecting arms.

3. The clot retrieval device of claim 2 , wherein the first body segment comprises two pairs of struts, each strut terminating at a respective distal apex and forming a proximal boundary of a respective one of the two entrance openings.

4. The clot retrieval device of claim 1 , wherein the two connecting arms extend substantially parallel to the longitudinal axis of the clot retrieval device.

5. The clot retrieval device of claim 1 , wherein the two connecting arms are positioned approximately 180° from each other around the circumference of the outer expandable member.

6. The clot retrieval device of claim 1 , wherein the first body segment and the second body segment are connected to each other only via the two connecting arms.

7. 2. The clot retrieval device of claim 1, wherein each of the two connecting arms is configured to bend at a curvature having a radius smaller than the radius of curvature of the majority of struts of the first body segment and the second body segment when the clot retrieval device is pulled proximally through a tubular vasculature comprising a bend of approximately 180 degrees.

8. the outer expandable member comprises three or more body segments, each shaped substantially similarly to the first body segment and the second body segment; 2. The clot retrieval device of claim 1, wherein the outer expandable member comprises a pair of tapered connecting arms, whereby each respective pair of tapered connecting arms joins adjacent body segments of the three or more body segments in the direction in which the longitudinal axis extends.

9. The clot retrieval device of claim 1 , wherein alternating radiopaque markers of the four or more radiopaque markers are aligned in a plane perpendicular to the longitudinal axis when the clot retrieval device is in the folded configuration.

10. The clot retrieval device of claim 1 , wherein each of the four or more radiopaque markers comprises a radiopaque material positioned within an eyelet.

11. The clot retrieval device of claim 1 , wherein at least two of the four or more radiopaque markers are aligned with respective ones of the two connecting arms in the direction in which the longitudinal axis extends.

12. the inner expandable member includes a coil section located distal to the expansion section and expandable in the direction in which the longitudinal axis extends; 2. The blood clot retrieval device of claim 1, wherein when the inner expandable member changes from the collapsed configuration to the expanded configuration, the expansion section contracts in the direction in which the longitudinal axis extends, the diameter of the expansion section increases, and the coil section stretches in the direction in which the longitudinal axis extends.

Images