Floating blood clot recovery device for removing blood clots from blood vessels

Abstract

To provide a clot removal device.SOLUTION: A clot removal device includes: an elongated member including a distal end; and an expandable frame including a proximal end, and one or more frame members including one or more pinching cells operable to be slidably and rotatably placed thereon, each of the pinching cells including a collapsed state within a microcatheter and an expanded state distal to the microcatheter configured to tweeze at least a portion of a clot.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] The present disclosure relates generally to devices and methods for removing blockages from blood vessels during intravascular medical procedures. [Background technology]

[0002] Clot retrieval devices are often used in mechanical thrombectomy for endovascular interventions in cases where patients suffer from conditions such as acute ischemic stroke (AIS), myocardial infarction (MI), and pulmonary embolism (PE). Acute obstructions can include clots, misplaced devices, dislodged devices, large emboli, and the like. Thromboembolism occurs when part or all of a clot detaches from the 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 develops in the venous system or on the right side of the heart and lodges in the pulmonary artery or its branches. Clots can also develop in the form of emboli without being released and locally block a blood vessel, a mechanism that is common in the formation of coronary artery blockages. There are significant problems associated with designing clot removal devices that can provide a high level of performance. First, there are many access problems that make it difficult to deliver the device. When access involves navigating the aortic arch (such as in a coronary or cerebral occlusion), the shape of the aortic arch in some patients makes it difficult to position the guide catheter. These difficult aortic arch configurations are classified as Type II or Type III aortic arches, with Type III aortic arches presenting the greatest obstacle.

[0003] 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 the device to have to navigate vascular segments with 180° bends, 90° bends, and 360° bends over several centimeters of vessel without interruption. In the case of pulmonary embolism, access is 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 a clot retrieval device to be compatible with guide catheters that are as low profile and flexible as possible.

[0004] Second, the vasculature in areas where a clot may be lodged is often fragile and delicate. For example, the vessels of the neurovasculature are more fragile than similarly sized vessels in other parts of the body and lie in soft tissue beds. Excessive pulling forces applied to these vessels can result in perforation and bleeding. Although the pulmonary vessels are larger than those of the cerebral vasculature, they are also inherently delicate, especially the more distal pulmonary vessels.

[0005] Third, clots can include any of a variety of morphologies and consistencies. Long strings of softer clot material tend to clog in bifurcations or trifurcations, which can result in simultaneous occlusion of multiple vessels over significant lengths. More mature and organized clot material may be less compressible than softer new clots and may distend the flexible vessels in which it is clogged under the action of blood pressure. Furthermore, the inventors have discovered that the properties of a clot can be significantly altered by the action of a device interacting with it. Specifically, compression of the clot causes dehydration of the clot, dramatically increasing both its stiffness and its coefficient of friction. Summary of the Invention [Problem to be solved by the invention]

[0006] For any device to provide a high level of success in removing clots and restoring flow, it must overcome the problems discussed above. Existing devices do not adequately address these problems, particularly those related to vascular trauma and clot characteristics. [Means for solving the problem]

[0007] It is the object of the present design to provide a device and method that meets the above needs. Accordingly, a clot retrieval device is desirable for removing clots from the cerebral arteries of patients suffering from AIS, from the coronary arteries or graft vessels of patients suffering from MI, and from the pulmonary arteries of patients suffering from PE, as well as from other peripheral arterial and venous vessels where a clot is causing an obstruction.

[0008] In some embodiments, the device includes a clamping feature configured for placement proximate to the occlusion (e.g., in the middle carotid artery (ICA)). The device may be configured to reperfuse the vessel and / or remove the clot having a fibrin core. In some embodiments, the fibrin core may be at an intermediate or distal location within the clot surrounded by a relatively soft thrombus.

[0009] In some embodiments, the device can be configured to remove a clot within the M1 bifurcation.

[0010] In some embodiments, the device can be configured to remove clots within the M2 bifurcation.

[0011] In some embodiments, the device can include an elongate member including a distal end, an expandable frame having a proximal end and one or more frame members having one or more clamping cells operable to be slidably and rotatably disposed thereon, each of the clamping cells can include a collapsed state within the microcatheter and an expanded state distal to the microcatheter operable to tweeze at least a portion of the clot.

[0012] In some embodiments, one or more clamping cells can include a plurality of strut members operable to actuate and pinch a clot from a blood vessel between the plurality of strut members.

[0013] In some embodiments, multiple strut members can be positioned around one or more central strut members, with each strut member joined at a common respective proximal and distal end.

[0014] In some embodiments, each of the one or more clamping cells may be operable to pinch a clot upon movement from a collapsed state to an expanded clot clamping state until a portion of the clot is compressed between the plurality of strut members.

[0015] In some embodiments, the ratio of the diameter of each of the one or more sandwiched cells between the collapsed state and the expanded state can be between approximately 1.5:1 and 4:1.

[0016] In some embodiments, each of the one or more sandwiching cells can include a radiopaque marker.

[0017] In some embodiments, the one or more clamping cells can include a clamping structure including a plurality of strut members and one or more central strut members, a first collar having a first collar lumen, and a second collar having a second collar lumen.

[0018] In some embodiments, one or more strut members can be a network of struts operable to pick at least a portion of the clot, and the network of struts can be configured such that in the expanded state, at least a portion of the network of struts penetrates the clot.

[0019] In some embodiments, the first collar lumen and the second collar lumen can be operable to receive one or more frame members.

[0020] In some embodiments, the distal end of the elongate member can be attached to the proximal end of the expandable frame.

[0021] In some embodiments, one or more sandwiched cells can be selectively aligned in a plurality of orientations on one or more frame members.

[0022] In some embodiments, the expandable frame is generally a wave pattern having an increasing amplitude along its length.

[0023] In some embodiments, a method for removing a blood clot is disclosed. The method can include deploying an expandable frame from a delivery configuration within a blood vessel to a deployed configuration proximate to the blood clot. The expandable frame can include one or more frame members and one or more clamping cells located on the one or more frame members. Each of the clamping cells can include a collapsed state within the microcatheter and an expanded state distal to the microcatheter configured to clamp at least a portion of the blood clot, and the expandable frame is deployed such that the one or more clamping cells can contact the blood clot. The method can include advancing a lumen of the microcatheter over the expandable frame such that a portion of the expandable frame is at least partially collapsed within a lumen of the microcatheter and the one or more clamping cells are at least partially collapsed within the lumen of the microcatheter. The method can include clamping one or more clamping cells in contact with a portion of the clot during movement from a collapsed state to an expanded, clot-clamping state until a portion of the clot can be compressed between at least a pair of strut members of the one or more clamping cells, and withdrawing the microcatheter, the expandable frame, and the clot while clamping the one or more clamping cells.

[0024] In some embodiments, the pair of strut members may be operable to actuate and pick a blood clot from the blood vessel between the pair of strut members.

[0025] In some embodiments, a pair of strut members can be positioned around one or more central strut members, with each strut member joined at a common respective proximal and distal end.

[0026] In some embodiments, a method for manufacturing a clot removal device is disclosed. The method may include forming one or more clamping cells from a shape memory alloy tube. Each of the one or more clamping cells may include a plurality of strut members operable to clamp a clot, the plurality of strut members being positioned around one or more central strut members, each strut member being joined at a common respective proximal and distal end. The method may include forming at least a portion of an expandable frame having a proximal end and one or more frame members. The method may include assembling the one or more clamping cells with at least a portion of the expandable frame.

[0027] In some embodiments, forming one or more clamping cells from a shape memory alloy tube can include cutting the shape memory alloy tube into a plurality of sections, cutting a pattern into a section of the plurality of sections, attaching a radiopaque marker to each of the one or more clamping cells, and shaping the plurality of strut members and the one or more central strut members of the clamping structure to memorize an expanded state of the clamping structure, wherein the ratio of diameters of each of the one or more clamping cells between the collapsed state and the expanded state can be approximately 1.5:1 to 4:1.

[0028] In some embodiments, forming at least a portion of the expandable frame can include constructing one or more frame members over a mandrel, molding the one or more frame members to store a deployed configuration of the expandable frame based at least in part on the mandrel, and connecting the one or more frame members to form a distal end of the expandable frame.

[0029] In some embodiments, assembling one or more clamping cells with at least a portion of the expandable frame can include sliding the one or more clamping cells over one or more frame members and connecting the one or more frame members to form a proximal end of the expandable frame, wherein the one or more clamping cells can be selectively aligned in a plurality of orientations.

[0030] In some embodiments, the one or more clamping cells can include a first collar having a first collar lumen and a second collar including a second collar lumen, the first collar lumen and the second collar lumen can be operable to receive one or more frame members, and the plurality of strut members and the one or more central strut members can be a network of struts operable to engage at least a portion of the clot. The network of struts can be configured such that in the expanded state, at least a portion of the network of struts penetrates the clot.

[0031] Other aspects and features of the present disclosure will become apparent to those of skill in the art from the following detailed description considered in conjunction with the accompanying figures. [Brief description of the drawings]

[0032] The above and further aspects of the present disclosure are further considered in conjunction with the following description of the attached drawings, in which like numerals in various drawings indicate like structural elements and features. The drawings are not necessarily to scale, instead, emphasis is placed on illustrating the principles of the present disclosure. The figures depict one or more implementations of the device of the present invention, merely by way of example and not by way of limitation. It is expected that those skilled in the art can conceive and combine elements from multiple drawings to better meet the needs of users. [Figure 1A] 1 illustrates a close-up view of an exemplary sandwich cell. [Figure 1B] 1 illustrates the movement of an exemplary clamping cell on a wire. [Figure 2A] 1 illustrates an exemplary clot removal device in a deployed configuration. [Figure 2B] 1 illustrates an exemplary clot removal device in a delivery configuration. [Diagram 3] 1 is a flow chart illustrating a method for removing a blood clot. [Figure 4A] 1 shows a close-up view of an exemplary clot removal device penetrating a clot. [Figure 4B] 1 shows a close-up view of an exemplary clot removal device clamping a clot. [Figure 4C] 1 shows a close-up view of an exemplary clot removal device capturing a clot. [Diagram 5] 1 illustrates an exemplary frame pattern for an exemplary clot removal device. [Figure 6] 1 illustrates an exemplary frame pattern for an exemplary clot removal device. [Figure 7A] 1 illustrates an exemplary frame pattern for an exemplary clot removal device. [Figure 7B] 1 illustrates an exemplary frame pattern for an exemplary clot removal device. [Figure 8A] 1 illustrates an exemplary frame pattern for an exemplary clot removal device. [Figure 8B] 1 illustrates an exemplary frame pattern for an exemplary clot removal device. [Figure 9] 1 illustrates an exemplary clot fragment collection section. [Figure 10] 1 is a flow chart illustrating a method of manufacturing a clot removal device. [Figure 11A] 1 illustrates a clamping cell in an expanded clamped state. [Figure 11B] 1 illustrates a sandwiched cell in a folded sandwiched state. [Figure 11C] 1 illustrates a clamping cell in an expanded clamped state. [Figure 12A] 1 illustrates an exemplary sandwich cell according to an aspect of the present disclosure. [Figure 12B] 1 illustrates an exemplary sandwich cell according to an aspect of the present disclosure. [Figure 12C]1 illustrates an exemplary sandwich cell according to an aspect of the present disclosure. [Figure 12D] 1 illustrates an exemplary sandwich cell according to an aspect of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] Specific embodiments of the present disclosure will now be described in detail with reference to the drawings, where like reference numbers indicate functionally similar or identical elements. The embodiments address many of the deficiencies associated with conventional catheters, such as inefficient clot removal and inaccurate deployment of the catheter to the target site.

[0034] Accessing various blood vessels in the vasculature, whether coronary, pulmonary, or cerebral, involves well-known procedural steps and the use of numerous conventional, commercially available accessory products. These products, such as angiographic contrast agents and guidewires, are widely used in examination and medical procedures. When these products are used with the systems and methods of the present disclosure in the following description, their functions and exact configurations will not be described in detail.

[0035] The following detailed description is merely exemplary in nature and is not intended to limit the disclosure or the application and uses of the disclosure. Although the disclosure is described often in the context of treating intracranial arteries, the invention may also be used in other body passageways as mentioned above.

[0036] Although specific embodiments of the present disclosure have been illustrated and described above, it will be apparent from the above description that various modifications can be made without departing from the spirit and scope of the present disclosure. For example, while the embodiments described herein refer to certain features, the present disclosure includes embodiments having different combinations of features. The present disclosure also includes embodiments that do not include all of the specific features described. Specific embodiments of the present disclosure are described in detail below with reference to the drawings, in which like reference numbers indicate identical or functionally similar elements. The terms "distal" or "proximal" are used in the following description with reference to a position or direction relative to the treating physician. "Distal" or "distally" refers to a position away from the physician or a direction away from the physician. "Proximal" or "proximal" or "proximal" refers to a position close to the physician or a direction toward the physician.

[0037] Accessing the cerebral, coronary and pulmonary veins involves the use of a number of commercially available products and conventional procedural steps. Access products such as guidewires, guide catheters, angiography catheters and microcatheters are described elsewhere and are routinely used in catheterization procedures. In the following description, these products and methods are assumed to be used in conjunction with the devices and methods of the present disclosure and need not necessarily be described in detail.

[0038] The following detailed description is merely exemplary in nature and is not intended to limit the disclosure or the application and uses of the disclosure. Although the disclosure is described often in the context of treating intracranial arteries, the disclosure may also be used in other body passageways as mentioned above.

[0039] FIG. 1A shows a close-up view of an exemplary clamping cell 100. The clamping cell 100 can be configured to embed into and / or engage and grasp a clot to securely hold it for retraction. It is understood that each of the clamping cells described herein can be used interchangeably with a clot retrieval device, as needed or desired. The clamping cell 100 can include a first collar 102, a first lumen 104, a second collar 106, and a second lumen 108 between which the clamping structure 110 is positioned (e.g., between the first and second collars). The clamping structure 110 can include strut members 112a, 112b, 112c, and 112d. One or more of the strut members 112a, 112b, 112c and 112d may be curved or otherwise configured to include a tensioned bend such that they may be embedded within a clot and then actuated to grip and / or clamp the clot during use. The term "curved" is intended to refer to struts that are generally in the shape of an arc, while "tensioned bent" is intended to refer to struts that have been placed under tension and plastically deformed into a desired shape.

[0040] In some embodiments, the clamping cell 100 can be actuated into the expanded clamping state by being unsheathed from a sheath (e.g., a microcatheter), by being pulled or actuated by one or more tensioning members, or by providing an electrical current to one or more strut members 112a, 112b, 112c, and 112d to change at least a first portion of the one or more strut members 112a, 112b, 112c, and 112d from the expanded state to the clamping state. The clamping cell 100 can be configured to embed and grasp, clamp, and / or "pick" a clot, as more particularly shown and described in FIGS. 11A-11C. As discussed herein, the terms "pick" or "picking" are intended to refer to the clamping or squeezing cell sheathing that causes the respective struts to come together and pinch or grasp at least a portion of the clot. In this regard, the number of struts in each cell need not be limited, but can include at least two strut surfaces to pick up corresponding clot material. One or more of the strut members 112a, 112b, 112c, and 112d can also have one or more radiopaque bands to indicate to a user when the clamping cell 100 is clamped, as the distance between the struts decreases when the clamping cell 100 transitions from the expanded state to the expanded clamped state.

[0041] The diameter of the clamping cell 100 can range from approximately 2 to 10 millimeters, depending on what the design profile allows. One preferred diameter can be approximately 2.25 millimeters. In some embodiments, the clamping cell 100 can be small enough to fit into a 0.021 or 0.018 inch ID microcatheter.

[0042] The pinching cell 100 can be constructed from a superelastic material such as Nitinol, or an alloy of similar properties. The material can be in many forms such as wire or strip or 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. This framework can be in any of a very wide range of shapes as disclosed herein, and can be visualized under fluoroscopy through the addition of alloying elements (e.g., platinum) or through various other coatings or marker bands. The pinching cell 100 can include a collapsed state for delivery and an expanded state distal to the microcatheter for clot retrieval, flow restoration, and / or tear protection. To move between the collapsed and expanded states, the pinching cell 100 can be configured to self-expand to an expanded diameter upon delivery from the microcatheter (e.g., release from the microcatheter), as discussed in detail in FIGS. 11A-11C.

[0043] 1B, an exemplary clamping cell 100 is shown disposed on a wire 114 that can pass through first lumen 104 and second lumen 108. Passing the wire 114 in this regard can enable the clamping cell 100 to slide along an A-axis, as indicated by arrow S, and rotate about the A-axis, as indicated by arrow R. The A-axis can be defined, for example, in alignment with the wire 114 or a similar device.

[0044] 2A illustrates an exemplary clot removal device 200 in a deployed configuration. The exemplary device 200 can include a microcatheter 202 having a lumen 204, a distal end 206, and a proximal end 208. The device 200 can include an expandable frame 210 having a distal end 212, a proximal end 214, and one or more frame members 216a, 216b, and 216c. The one or more frame members 216a, 216b, and 216c can have one or more clamping cells 100 slidably and / or rotatably arranged therein, as discussed in FIG. 1B. The device 200 can include an elongated member 218 having a distal end 219. The distal end 219 of the elongated member 218 can be connected to the proximal end 214 of the expandable frame 210. The expandable frame 210 may be constructed from a superelastic material such as Nitinol, or an alloy with similar properties.

[0045] 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, followed by heat treating and electropolishing the resulting structure to create a framework of frame members. This framework can be in any of a very wide range of shapes as disclosed herein, and can be visualized under fluoroscopy through the addition of alloying elements (e.g., platinum) or through various other coatings or marker bands. The elongated member 218 can be a tapered wire shaft and can be made from stainless steel, MP35N, Nitinol, or other materials of suitably high elastic modulus and tensile strength. As described above, the device 200 can include a delivery configuration for delivery, as well as a deployed configuration for clot retrieval, flow restoration, and / or tear protection. To move between the delivery and deployed configurations, the expandable frame 210 can be configured to self-expand to a diameter greater than the diameter of the lumen 204 of the microcatheter 202 upon delivery from the microcatheter 202 (e.g., release from the microcatheter). In the deployed configuration, the expandable frame 210 can be distal to the distal end 206 of the microcatheter 202. The clamping cell 100 can be in an expanded state and a folded state, as discussed in more detail in FIGS. 11A-11C. In the delivery configuration, the expandable frame 210 can be within the lumen 204 of the microcatheter 202. Turning to FIG. 2B, the device 200 is shown in a folded delivery configuration within the lumen 204 of the microcatheter 202. Additionally, the clamping cell 100 can be in a folded state, as discussed in more detail in FIGS. 11A-11C.

[0046] FIG. 3 is a flow diagram illustrating a method of removing a clot according to an embodiment of the present disclosure. The method steps of FIG. 3 can be performed by any of the exemplary means described herein or by similar means, as will be appreciated. With reference to the method 300 outlined in FIG. 3, in step 302, an expandable frame is deployed from a delivery configuration to a deployed configuration in a blood vessel to be proximate to the clot, the expandable frame can include one or more frame members and one or more clamping cells located on the one or more frame members. Each of the clamping cells can include a folded state within the microcatheter and an expanded state distal to the microcatheter configured to clamp at least a portion of the clot, and the expandable frame can be deployed such that the one or more clamping cells are in contact with the clot. In step 304, the lumen of the microcatheter is advanced over the expandable frame such that a portion of the expandable frame is at least partially folded within the lumen of the microcatheter and the one or more clamping cells are at least partially folded within the lumen of the microcatheter. At step 306, one or more clamping cells contacting a portion of the clot during the transition from the collapsed state to the expanded clot clamping state are clamped until a portion of the clot is compressed between at least a pair of struts of the one or more clamping cells. Additionally or alternatively, the pair of strut members may be operable to actuate and pick the clot from the vessel between the strut members. Additionally or alternatively, the pair of strut members are positioned around a central strut member, each of the strut members being joined at a common respective proximal and distal end. At step 308, the microcatheter, the expandable frame, and the clot are withdrawn while the one or more clamping cells withdrawing the microcatheter are clamped. The method 300 may end after step 308. In other embodiments, additional steps according to the above examples may be performed.

[0047] 4A-4C show close-up views of an exemplary clot removal device 200 penetrating, clamping, and capturing a clot 1. In FIG. 4A, the device 200 is shown in a deployed configuration with the expandable frame 210 positioned proximate to (e.g., embedding or otherwise contacting) the clot 1. The clamping cells 100 are capable of penetrating the clot 1. In FIG. 4B, a microcatheter 202 is armored over the expandable frame 210 and the clamping cells 100, causing the clamping cells 100 to clamp a portion of the clot 1. Each clamping cell 100 provides an enhanced grip on the clot 1 and any fragments thereof. Each of the clamping cells 100 may be particularly advantageous for capturing clots that may have a fibrin core at a central, distal, or proximal location within the clot 1. Furthermore, during use, if a portion of the clot 1 is missed by one clamping cell 100, one or more clamping cells 100 distal thereto can engage and / or grasp the clot 1. In an embodiment, a portion of the clot 1 can be clamped between the distal end 206 of the microcatheter 202 and the expandable frame 210. In FIG. 4C, the clot 1 is captured by the device 200. At least a portion of the clot 1 can be secured by the clamping cells 100 within the lumen 204 of the microcatheter 202, where it is sheathed over the expandable frame 210 and the clamping cells 100. The device 200 can be in a delivery configuration. Additionally or alternatively, the device 200 can be in a fixed configuration in a deployed configuration. Additionally or alternatively, the device 200 can be in a clamping configuration in a deployed configuration. Each clamping cell 100 provides an enhanced grip on the clot 1 and any fragments thereof. Each of the clamping cells 100 may be particularly advantageous for capturing a clot, which may have a fibrin core at a central, distal, or proximal location within the clot 1. Furthermore, during use, if a portion of the clot 1 is missed by one clamping cell 100, the distal one or more clamping cells 100 may engage and / or grasp the clot 1.

[0048] 5 illustrates an exemplary pattern of an exemplary expandable frame. The exemplary expandable frame 500 may be a helix and includes a frame member 502, a distal end 504, and a proximal end 506. The proximal end 506 may be configured to connect to the distal end 219 of the elongate member 218. One or more clamping cells 100 may be slidably and / or rotatably disposed on the frame member 502. The expandable frame 500 may be constructed from Nitinol or other suitable material.

[0049] 6 illustrates an exemplary pattern of an exemplary expandable frame. The exemplary expandable frame 600 may be a double helix and includes a first frame member 602, a second frame member 604, a distal end 606, and a proximal end 608. The first and second frame members 602, 604 may be connected to one another at the distal end 606 and the proximal end 608. The proximal end 608 may be configured to connect to the distal end 219 of the elongate member 218. One or more clamping cells 100 may be slidably and / or rotatably disposed on the first and second frame members 602, 604. The expandable frame 600 may be constructed of Nitinol or other suitable material.

[0050] 7A-7B show an exemplary expandable non-tubular curved atraumatic frame pattern that can be actuated to grip and / or pinch, such as between one or more peaks of the frame pattern and a blood clot or fragments thereof. FIG. 7A illustrates an exemplary expandable frame 700 having a frame member 702, a distal end 704, and a proximal end 706. The wave pattern can be defined by a wavelength L1 and a generally consistent amplitude H1 between the proximal and distal ends. The proximal end 706 can be configured to connect to the distal end 219 of the elongate member 218. One or more pinching cells 100 can be slidably and rotatably disposed on the frame member 702. FIG. 7B illustrates an exemplary expandable frame 750 having a frame member 752, a distal end 754, and a proximal end 756. The wave pattern can be defined by a wavelength L2 and a first amplitude H2 that can transition to a second amplitude H3 that is generally greater than the first amplitude H2. The proximal end 756 can be configured to connect to the distal end 219 of the elongate member 218. One or more clamping cells 100 can be slidably and rotatably disposed on the frame member 752. The exemplary expandable frames 700, 750 can be constructed from Nitinol or other suitable materials.

[0051] 8A-8B also show an exemplary expandable non-tubular frame pattern that can be actuated to grip and / or pinch, such as between one or more peaks of the frame pattern and a blood clot or fragments thereof. FIG. 8A illustrates an exemplary expandable frame 800 having a frame member 802, a distal end 804, and a proximal end 806. The relatively sharp non-curved pattern can be defined by a wavelength L3 and a generally consistent amplitude H4 between the proximal and distal ends. The proximal end 806 can be configured to connect to the distal end 219 of the elongate member 218. One or more pinching cells 100 can be slidably and rotatably disposed on the frame member 802. FIG. 8B illustrates an exemplary expandable frame 850 having a frame member 852, a distal end 854, and a proximal end 856. The pattern can be defined by a wavelength L4 and a first amplitude H5 that can transition to a second amplitude H6 that is generally greater than the first amplitude H5. The proximal end 756 can be configured to connect to the distal end 219 of the elongate member 218. One or more clamping cells 100 can be slidably and rotatably disposed on the frame member 852. The exemplary expandable frames 800, 850 can be constructed from Nitinol or other suitable material.

[0052] 9 illustrates an exemplary clot removal device 900. The device 900 can include a clot fragment collecting section 902 located at the distal end 212 of the expandable frame 210. The clot fragment collecting section 902 (e.g., a distal net, mesh, etc.) can be configured to entangle clot fragments disrupting the clot 1.

[0053] 10 is a flow diagram illustrating a method of manufacturing a clot removal device according to an embodiment of the present disclosure. The method steps of FIG. 10 can be performed by any of the exemplary means described herein or by similar means, as will be appreciated. Referring to method 1000 as generally shown in FIG. 10, in step 1002, one or more clamping cells are formed from a shape memory alloy tube, each of the one or more clamping cells including a plurality of strut members operable to clamp a clot, the plurality of strut members being positioned around one or more central strut members, each strut member being joined at a common respective proximal and distal end. Forming the one or more clamping cells may further include cutting the shape memory alloy tube into a plurality of sections, cutting a pattern into a section of the plurality of sections, attaching a radiopaque marker to each of the one or more clamping cells, and shaping the plurality of strut members and the one or more central strut members of the clamping structure to memorize an expanded state of the clamping structure, wherein a ratio of diameters of each of the one or more clamping cells between a collapsed state and an expanded state is approximately 1.5:1 to 4:1. In step 1004, at least a portion of an expandable frame is formed, including a proximal end and one or more frame members.

[0054] Forming at least a portion of the expandable frame may further include constructing one or more frame members on a mandrel, molding the one or more frame members to store the deployed configuration of the expandable frame based at least in part on the mandrel, and connecting the one or more frame members to form a distal end of the expandable frame. In step 1006, one or more clamping cells are assembled with at least a portion of the expandable frame. Assembling the one or more clamping cells with at least a portion of the expandable frame may further include sliding the one or more clamping cells over the one or more frame members, and connecting the one or more frame members to form a proximal end of the expandable frame. The one or more clamping cells may be selectively aligned in a plurality of orientations. The method 1000 may end after step 1006. In other embodiments, additional steps according to the above examples may be performed.

[0055] 11A-11C illustrate exemplary pinching cell states. An exemplary expanded state of the pinching cell 100 is shown in FIG. 11A. The pinching structure 110 has an expanded diameter D1 that may be realized distal to the distal end 206 of the microcatheter 202. An exemplary folded state of the pinching cell 100 is shown in FIG. 11B. The pinching structure 110 has a folded diameter D2 that may be realized within the lumen 204 of the microcatheter 202. An exemplary pinching state of the expanded state of the pinching cell 100 is shown in FIG. 11C. The pinching structure 110 has a diameter smaller than the expanded diameter D1 but larger than the folded diameter D2. Additionally or alternatively, the diameter ratio can be calculated, for example, by dividing the expanded diameter D1 by the folded diameter D2. Additionally or alternatively, the diameter ratio can be calculated by dividing the folded diameter D2 by the expanded diameter D1.

[0056] FIG. 12A shows a close-up view of another exemplary sandwiched cell 1200a having strut members 1202a, 1204a, and 1206a, here shown with undulating edges. These undulations can be formed by heat setting, crimping, or otherwise forming as needed or desired. FIG. 12B shows a close-up view of another exemplary sandwiched cell 1200b having strut members 1202b, 1204b, and 1206b, each including one or more eyelets. FIG. 12C shows a close-up view of another exemplary sandwiched cell 1200c having strut members 1202c, 1204c, and 1206c, here shown with relatively straight, non-curved strut members. 12D shows a close-up view of another example sandwiching cell 1200d having strut members 1202d, 1204d, and 1206d each including one or more notches or indentations that can be formed by heat setting, crimping, or otherwise formed as needed or desired.

[0057] The present disclosure is not limited to the described examples, which may vary in configuration and details. The terms "distal" and "proximal" are used throughout the foregoing description and are meant to refer to a location and direction relative to the treating physician. Thus, "distal" or "distally" refers to a location away from the physician or a direction away from the physician. Similarly, "proximal" or "proximally" refers to a location closer to the physician or a direction toward the physician.

[0058] In describing the embodiments, technical terms are used for clarity. Each term is intended to have its broadest meaning as understood by those skilled in the art, and is intended to include all technical equivalents that operate in a similar manner to achieve a similar purpose. It should also be understood that the reference to one or more steps of a method does not exclude the presence of additional method steps or intervening method steps between those steps that are explicitly identified. Each step of the method can 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 the reference to one or more components in a device or system does not exclude the presence of additional components or intervening components between those components that are explicitly identified.

[0059] As discussed herein, a "patient" or "subject" may be a human or any animal. It should be understood that the animal may be of any of a variety of relevant types, including, but not limited to, mammals, veterinary animals, livestock animals, or pet animals. As an example, the animal may be a laboratory animal (e.g., rats, dogs, pigs, monkeys, etc.) that has been specifically selected to have certain characteristics similar to humans.

[0060] The term "about" or "approximately" as used herein with respect to any numerical value or range of numerical values ​​indicates 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%.

[0061] "Comprising" or "containing" or "including" or "having" 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, substances, particles, or method steps, even if those other compounds, substances, particles, or method steps have the same function as the one specified.

[0062] 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. Ranges can be expressed herein as from "about" or "approximately" one particular value and / or to "about" or "approximately" another particular value. When such a range is expressed, other exemplary embodiments include from the one particular value and / or to the other particular value.

[0063] 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. Although specific examples of the present disclosure are described, various modifications to the devices and methods can be made without departing from the scope and spirit of the present disclosure. For example, the examples described herein refer to specific components, but 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 examples, combine components from various examples with known components, and the like. The present disclosure contemplates the replacement of component parts illustrated herein with other well-known commercially available products. These modifications will be apparent in many cases to those skilled in the art to which the present disclosure pertains, and are intended to be within the scope of the following claims.

[0064] [Embodiment] (1) A blood clot removal device, comprising: an elongate member having a distal end; 1. An expandable frame, comprising: A proximal end; a clot removal device comprising: an expandable frame comprising one or more frame members having one or more clamping cells operable to be slidably and rotatably disposed thereon, each of the clamping cells including a collapsed state within the microcatheter and an expanded state distal to the microcatheter operable to pick at least a portion of a clot; (2) The clot removal device of embodiment 1, wherein the one or more clamping cells comprise a plurality of strut members, the plurality of strut members operable to actuate and pick the clot from the blood vessel between the plurality of strut members. (3) The clot removal device of embodiment 2, wherein the plurality of strut members are positioned around one or more central strut members, and each of the strut members is joined at a common respective proximal and distal end. (4) A clot removal device as described in embodiment 2, wherein each of the one or more clamping cells is operable to pinch the clot upon movement from the collapsed state to the expanded clot clamping state until a portion of the clot is compressed between the plurality of strut members. (5) A blood clot removal device as described in embodiment 2, wherein the ratio of the diameter of each of the one or more clamping cells between the folded state and the expanded state is approximately 1.5:1 to 4:1.

[0065] (6) A blood clot removal device as described in embodiment 2, wherein each of the one or more clamping cells includes a radiopaque marker. (7) The one or more sandwiching cells are a clamping structure comprising a plurality of strut members and one or more central strut members; a first collar having a first collar lumen; 2. The clot removal device of embodiment 1, further comprising: a second collar having a second collar lumen. (8) One or more clamping cells as described in embodiment 7, wherein the one or more strut members are a network of struts operable to pick at least a portion of the blood clot, the network of struts being configured such that in an expanded state, at least a portion of the network of struts penetrates the blood clot. (9) The one or more clamping cells described in embodiment 7, wherein the first collar lumen and the second collar lumen are operable to receive one or more frame members. (10) The clot removal device of embodiment 1, further comprising an elongated member having a distal end, the distal end of the elongated member being attached to the proximal end of the expandable frame.

[0066] (11) A blood clot removal device as described in embodiment 1, wherein the one or more clamping cells are selectively aligned in multiple orientations on one or more frame members. (12) The clot removal device of embodiment 1, wherein the expandable frame is generally a wave pattern having an increasing amplitude along its length. (13) A method for retrieving a blood clot, comprising: deploying an expandable frame within a blood vessel from a delivery configuration to a deployed configuration adjacent to a clot, the expandable frame comprising one or more frame members and one or more clamping cells located on the one or more frame members, each of the clamping cells including a collapsed state within a microcatheter and an expanded state distal to the microcatheter configured to clamp at least a portion of the clot, the expandable frame being deployed such that the one or more clamping cells are in contact with the clot; advancing a lumen of the microcatheter over the expandable frame such that a portion of the expandable frame is at least partially folded within the lumen of the microcatheter and one or more clamping cells are at least partially folded within the lumen of the microcatheter; clamping the one or more clamping cells in contact with the portion of the clot during movement from the collapsed state to the expanded, clot-clamping state until the portion of the clot is compressed between at least one pair of strut members of the one or more clamping cells; and withdrawing the microcatheter, the expandable frame, and the clot while clamping the one or more clamping cells. (14) The method of claim 13, wherein the pair of strut members are operable to actuate and pick the clot from the blood vessel between the pair of strut members. (15) The method of embodiment 14, wherein the pair of strut members are positioned around one or more central strut members, each strut member being joined at a common respective proximal and distal end.

[0067] (16) A method for manufacturing a blood clot removal device, comprising: forming one or more clamping cells from a shape memory alloy tube, each of the one or more clamping cells comprising a plurality of strut members operable to clamp a blood clot, the plurality of strut members positioned around one or more central strut members, each of the strut members being joined at a common respective proximal and distal end; forming at least a portion of an expandable frame comprising a proximal end and one or more frame members; and assembling the one or more sandwiching cells with at least a portion of the expandable frame. (17) The step of forming one or more sandwiched cells from a shape memory alloy tube comprises: cutting the shape memory alloy tube into a plurality of sections; cutting the pattern into a section of the plurality of sections; attaching a radiopaque marker to each of the one or more clamping cells; The method of embodiment 16, further comprising a step of shaping the plurality of strut members and one or more central strut members of the clamping structure to memorize an expanded state of the clamping structure, wherein the ratio of the diameter of each of the one or more clamping cells between the collapsed state and the expanded state is approximately 1.5:1 to 4:1. (18) The step of forming at least a portion of the expandable frame comprises: building one or more frame members over a mandrel; molding one or more frame members to store a deployed configuration of the expandable frame based at least in part on the mandrel; 17. The method of embodiment 16, further comprising the step of connecting one or more frame members to form a distal end of the expandable frame. (19) The step of assembling the one or more sandwiching cells with at least a portion of the expandable frame comprises: sliding one or more clamping cells over one or more frame members; and connecting one or more frame members to form a proximal end of the expandable frame. 17. The method of embodiment 16, wherein one or more sandwiched cells are selectively aligned in multiple orientations. (20) The one or more sandwiching cells are a first collar having a first collar lumen; a second collar having a second collar lumen; the first collar lumen and the second collar lumen are operable to receive one or more frame members; The method of embodiment 16, wherein the plurality of strut members and the one or more central strut members are a network of struts operable to engage at least a portion of a blood clot, the network of struts being configured such that in an expanded state, at least a portion of the network of struts penetrates the blood clot.

Claims

1. A blood clot removal device, an elongated member having a distal end, an expandable frame, a proximal end, a distal end, two or more frame members coupled at the proximal end and the distal end of the expandable frame, each of the two or more frame members comprising one or more clamping cells operable to be slidably and rotatably disposed thereon, each of the one or more clamping cells including a folded state within a microcatheter and an expanded state distal to the microcatheter operable to pick at least a portion of a blood clot, and an expandable frame comprising two or more frame members.

2. The blood clot removal device according to claim 1, wherein the one or more clamping cells comprise a plurality of strut members, and the plurality of strut members are operable to actuate to pick the blood clot from a blood vessel between the plurality of strut members.

3. The blood clot removal device according to claim 2, wherein the plurality of strut members are positioned around one or more central strut members, and each of the strut members is joined at a common respective proximal end and distal end.

4. The blood clot removal device according to claim 2, wherein each of the one or more clamping cells is operable to pick the blood clot during movement from the folded state to an expanded blood clot clamping state until a portion of the blood clot is compressed between the plurality of strut members.

5. The blood clot removal device according to claim 2, wherein a ratio of diameters of each of the one or more clamping cells between the folded state and the expanded state is approximately 1.5:1 to 4:

1.

6. The blood clot removal device according to claim 2, wherein each of the one or more clamping cells includes a radiopaque marker.

7. The one or more clamping cells, a clamping structure comprising a plurality of strut members and one or more central strut members, a first collar having a first collar lumen, and a second collar having a second collar lumen. **Claim 8**: One or more of the plurality of strut members and one or more of the one or two or more central strut members are a network structure of struts operable to pick at least a part of the blood clot, and in the expanded state, at least a part of the network structure of the struts is configured to penetrate the blood clot. The blood clot removal device according to claim 7. **Claim 9** The blood clot removal device according to claim 7, wherein the first collar lumen and the second collar lumen are operable to receive the two or more frame members. **Claim 10** The blood clot removal device according to claim 1, further comprising an elongated member having a distal end, and the distal end of the elongated member is attached to the proximal end of the expandable frame. **Claim 11** The blood clot removal device according to claim 1, wherein the one or more clamping cells are selectively aligned in a plurality of orientations on the two or more frame members. **Claim 12** The blood clot removal device according to claim 1, wherein the expandable frame is generally a waveform pattern having an amplitude increasing along its length. **Claim 13** A method for manufacturing a blood clot removal device, a step of forming one or more clamping cells from a shape memory alloy tube, each of the one or more clamping cells comprising a plurality of strut members operable to clamp a blood clot, the plurality of strut members being positioned around one or two or more central strut members, and each of the plurality of strut members and the one or two or more central strut members being joined at a common respective proximal end and distal end; the forming step; a step of forming at least a part of an expandable frame comprising a proximal end, a distal end, and two or more frame members, the forming step including connecting the two or more frame members to form the distal end of the expandable frame; a method comprising: an assembling step of assembling the one or more clamping cells together with at least a part of each of the two or more frame members, the assembling step including connecting the two or more frame members to form the proximal end of the expandable frame. **Claim 14**: The step of forming one or more clamping cells from the shape memory alloy tube comprises a step of cutting the shape memory alloy tube into a plurality of sections; a step of cutting the pattern into a certain section among the plurality of sections; a step of attaching a radiopaque marker to each of the one or more clamping cells; a step of shaping a plurality of strut members and one or two or more central strut members of the clamping structure so as to memorize an expanded state of the clamping structure, wherein a ratio of diameters of each of the one or two or more clamping cells between a folded state and the expanded state is approximately 1.5:1 to 4:1, the step of shaping; The method according to claim 13, further comprising.

15. The step of forming at least a part of the expandable frame, a step of constructing the two or more frame members on a mandrel; a step of shaping the two or more frame members so as to memorize a deployed configuration of the expandable frame, at least partially based on the mandrel; The method according to claim 13, further comprising.

16. The step of assembling the one or two or more clamping cells together with at least a part of each of the two or more frame members, a step of sliding the one or two or more clamping cells on the two or more frame members, further comprising, The method according to claim 13, wherein the one or two or more clamping cells are selectively aligned in a plurality of orientations.

17. The one or two or more clamping cells, a first collar having a first color lumen; a second collar having a second color lumen, further comprising, the first color lumen and the second color lumen are operable to receive the two or more frame members; the plurality of strut members and the one or two or more central strut members are a network structure of struts operable to engage at least a part of a blood clot, and at least a part of the network structure of struts in an expanded state is configured to penetrate the blood clot. The method according to claim 13.

18. Each of the two or more frame members includes two or more of the clamping cells, and each of the two or more clamping cells, a clamping structure including a plurality of strut members and one or two or more central strut members; a first collar having a first color lumen; a second collar having a second color lumen; The blood clot removal device according to claim 1.

19. The step of assembling the one or two or more clamping cells together with at least a part of each of the two or more frame members, further comprising sliding two or more of the clamping cells on each of the two or more frame members, each of the two or more clamping cells, a clamping structure comprising the plurality of strut members and the one or more central strut members, a first collar having a first collar lumen, The method according to claim 13, comprising a second collar having a second collar lumen.

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