Blood clot retrieval device for removing foreign blood clots from blood vessels

Abstract

To provide a clot removal device.SOLUTION: A clot removal device can include a caged portion which can include: a distal end; a proximal end; an inner cage having a network structure of inner struts; and an outer cage having a network structure of outer struts. The inner cage and the outer cage can include a delivery configuration within a microcatheter and a deployed configuration distal to the microcatheter operable to retrieve at least a portion of the clot. The device can include a distal pinching portion located proximately to the distal end of the caged portion, and a proximal pinching portion located proximately to the proximal end of the caged portion, where each pinching portion can include at least one pinching cell which can include a collapsed state and an expanded state distal to the microcatheter operable to tweeze at least a portion of the clot.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure generally relates to devices and methods for removing obstructions from blood vessels during endovascular medical procedures.

Background Art

[0002] Thrombectomy devices are used for mechanical clot removal during endovascular intervention, particularly when a patient suffers from acute ischemic stroke (AIS), myocardial infarction (MI), pulmonary embolism (PE), etc. Acute occlusions can include blood clots, mispositioned devices, displaced devices, large emboli, etc. Thromboembolism occurs when part or all of a blood clot detaches from the vessel wall. This blood clot (herein referred to as an embolus) is then carried in the direction of blood flow. Ischemic stroke can result when a blood clot blocks the blood vessels in the brain. Pulmonary embolism can result when a blood clot forms in the venous system or on the right side of the heart and blocks in the pulmonary artery or its branches. Blood clots can also develop in the form of emboli without being released and locally block blood vessels, and this mechanism is common in the formation of coronary artery obstructions. There are significant challenges related to the design of thrombectomy devices that can provide high levels of performance. First, there are many access-related issues that make it difficult to deliver the device. When access involves navigating the aortic arch (such as in coronary artery occlusion or brain 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 problem of tortuosity is even more critical in arteries approaching the brain. For example, it is not uncommon at the distal end of the internal carotid artery for a device to have to continuously progress over several centimeters of blood vessel having 180° bends, 90° bends, and 360° bends. 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 blood vessels that can be easily damaged by inflexible or high-profile devices. For these reasons, it is desirable for clot retrieval devices to be compatible with guide catheters that are as low-profile and flexible as possible.

[0004] Second, the vasculature within regions where clots may be lodged is often fragile and delicate. For example, the blood vessels of the neurovascular bundle are more fragile than similarly sized blood vessels in other parts of the body and are in a soft tissue bed. Excessive tensile forces applied to these blood vessels can result in perforation and bleeding. The pulmonary vessels are larger than those of the cerebrovascular system but are also inherently delicate, particularly the more distal pulmonary vessels.

[0005] Third, clots can include any of a range of shapes and consistencies. Long, stringy, softer clot material tends to clog at bifurcations or trifurcations, such that multiple blood vessels may be occluded simultaneously over a significant length. More mature and organized clot material may be less compressible than softer, fresher clots and, under the action of blood pressure, can expand the soft blood vessels in which it is lodged. Further, 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 a clot causes dehydration of the clot, resulting in a dramatic increase in both the hardness and coefficient of friction of the clot. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION

[0006] In order for any device to achieve a high level of success in removing blood clots and restoring flow, it is necessary to overcome the problems described above. Existing devices do not adequately address these problems, particularly those associated with vascular trauma and blood clot characteristics.

Means for Solving the Problems

[0007] It is an object of the present design to provide a device and method that meet the above needs. Therefore, it is desirable for a blood clot retrieval device to remove blood clots from the major cerebral arteries of patients suffering from AIS, from the native coronary vessels or graft vessels of patients suffering from MI, from the pulmonary arteries of patients suffering from pulmonary embolism, and from other peripheral arteries and veins where blood clots are causing occlusion.

[0008] In some examples, the device includes a clamping mechanism along the site of occlusion (e.g., in the middle of the internal carotid artery (ICA)). The device can be configured to reperfuse the blood vessel and / or remove a blood clot having a fibrin core. In some examples, the fibrin core may be in an intermediate or distal position within a blood clot surrounded by a relatively soft thrombus.

[0009] In some examples, the device can be configured to remove a blood clot within the M1 branch.

[0010] In some examples, the device can be configured to remove a blood clot within the M2 branch.

[0011] In some examples, the device can include a distal end, a proximal end, an inner cage having a reticulated structure of inner struts, and an outer cage having a reticulated structure of outer struts. The inner and outer cages can include a delivery configuration within the microcatheter and a deployed configuration distal of the microcatheter operable to retrieve at least a portion of a blood clot. The device can include a distal clamping portion positioned proximal to the distal end of the cage portion and a proximal clamping portion positioned proximal to the proximal end of the cage portion, each clamping portion can include at least one clamping cell, and can include a folded state and an expanded state distal of the microcatheter operable to pinch at least a portion of the blood clot.

[0012] In some examples, each clamping cell can include a plurality of strut members configured to actuate to clamp a blood clot between the plurality of strut members.

[0013] In some examples, the plurality of strut members can be positioned around a central strut member of the plurality of strut members, and each strut member is joined at a common respective proximal and distal end.

[0014] In some examples, each clamping cell can be operable to pinch a blood clot upon movement from a folded state to an expanded blood clot clamping state until a portion of the blood clot can be compressed between the plurality of strut members.

[0015] In some examples, each clamping cell can include a ratio where the ratio of the diameter of each clamping cell between the folded state and the expanded state can be approximately 1.5:1 to 4:1.

[0016] In some examples, each clamping cell can include a radiopaque marker disposed on the plurality of strut members.

[0017] In some examples, each clamping cell can include a clamping structure having a plurality of strut members and a central strut member of the plurality of strut members, a first collar having a first collar lumen, and a second collar having a second collar lumen, and the plurality of strut members and the central strut member connect the first collar to the second collar.

[0018] In some examples, the inner cage can be a plurality of clamping cells operable to pick at least a portion of the blood clot.

[0019] In some examples, each cell of the plurality of clamping cells can include a clamping structure having a plurality of strut members and a central strut member of the plurality of strut members, a first collar having a first collar lumen, and a second collar having a second collar lumen, and the plurality of strut members and the central strut member connect the first collar to the second collar.

[0020] In some examples, the plurality of clamping cells can include at least one radiopaque marker disposed on the clamping structure.

[0021] In some examples, each cell of the plurality of clamping cells can include a folded state and an expanded state distal to the microcatheter operable to pick at least a portion of the blood clot.

[0022] In some examples, the device can include an elongate member that can include a distal end connected to the proximal end of the proximal clamping portion, and the elongate member is operable to move the blood clot retrieval device distally or proximally.

[0023] In some examples, the reticulated structure of the struts can be connectable to the reticulated structure of the inner struts.

[0024] In some examples, a method for removing a blood clot is disclosed. The method can include deploying, within a blood vessel and proximate to the blood clot, a clamping portion of a blood clot retrieval device from a folded state to an expanded state. The blood clot retrieval device can include a cage portion that can include a distal end, a delivery configuration within a microcatheter, and a deployed configuration distal to the microcatheter operable to retrieve at least a portion of the blood clot. The clamping portion can be positioned proximate to the distal end of the cage portion and can include a folded state and an expanded state distal to the microcatheter operable to clamp at least a portion of the blood clot. The method can include advancing the lumen of the microcatheter over the clamping portion such that the clamping portion is at least partially folded within the lumen of the microcatheter. The method can include clamping the clamping portion while in contact with a portion of the blood clot during movement from the folded state to the expanded blood clot clamping state until a portion of the blood clot can be compressed between the clamping portion and the microcatheter.

[0025] In some examples, the method can include determining that a portion of the blood clot is clamped and withdrawing the microcatheter, the blood clot retrieval device, and the blood clot from the blood vessel while maintaining the blood clot in the blood clot clamping state of the clamping portion.

[0026] In some examples, the method can include determining that a portion of the blood clot is not clamped and deploying, within the blood clot, the cage portion of the blood clot retrieval device from the delivery configuration to the deployed configuration such that the cage portion can be operable to capture at least a portion of the blood clot and withdrawing the microcatheter, the blood clot retrieval device, and the blood clot from the blood vessel while the blood clot remains embedded within the cage portion.

[0027] In some examples, the clamping portion can include a clamping structure having a plurality of strut members and a central strut member among the plurality of strut members, a first collar having a first collar lumen, and a second collar having a second collar lumen, and the plurality of strut members and the central strut member connect the first collar to the second collar.

[0028] In some examples, a method for removing a blood clot is disclosed. The method includes deploying, within a blood vessel and proximate to the blood clot, a clamping portion of a blood clot retrieval device from a collapsed state to an expanded state, the clamping portion being located proximate to a distal end of a cage portion of the blood clot retrieval device, the clamping portion including a collapsed state within a microcatheter and an expanded state distal of the microcatheter operable to clamp at least a portion of the blood clot. The method can include deploying, within a blood vessel and proximate to the blood clot, a cage portion of the blood clot retrieval device from a delivery configuration to a deployed configuration, the cage portion including a delivery configuration within a microcatheter and a deployed configuration distal of the microcatheter operable to retrieve at least a portion of the blood clot. The method can include advancing the lumen of the microcatheter over the clamping portion such that the clamping portion is at least partially collapsed within the lumen of the microcatheter and clamping the clamping portion in contact with a portion of the blood clot during movement from the collapsed state to the expanded blood clot clamping state until a portion of the blood clot can be compressed between the clamping portion and the microcatheter. The method can include retracting the microcatheter, the blood clot retrieval device, and the blood clot from the blood vessel while the blood clot is clamped by the clamping portion.

[0029] In some embodiments, the device can include a proximal clamping portion located proximate to a proximal end of the cage portion. The proximal clamping portion can include a proximal end, and the elongate member can include a distal end connected to the proximal end of the clamping portion. The elongate member can be operable to move the blood clot retrieval device in a distal or proximal direction.

[0030] In some embodiments, the clamping portion can include a clamping structure having a plurality of strut members and a central strut member among the plurality of strut members, and a first collar having a first collar lumen, and the second collar can include a second collar lumen, and the plurality of strut members and the central strut member connect the first collar to the second collar.

[0031] Other aspects and features of the present disclosure will become apparent to those skilled in the art by considering the following detailed description in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0032] The above and further aspects of the present disclosure will be further considered in conjunction with the following description of the accompanying drawings, and in the various drawings, like numerals indicate like structural elements and features. The drawings are not necessarily to scale, and 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 by way of illustration and not limitation. Those skilled in the art are expected to be able to envision and combine elements from the multiple figures to better suit the desires of the user.

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6A

Figure 6B

Figure 6C

Figure 6D

Figure 7A

Figure 7B

Figure 7C

Figure 8

Mode for Carrying Out the Invention

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

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

[0035] The following detailed description is merely exemplary in nature and is not intended to limit the present disclosure or its application and use. The description of the present disclosure is often in the context of treating intracranial arteries, but the present disclosure can also be used in other body conduits as described above.

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

[0037] Accessing the brain, coronary arteries, and pulmonary veins involves the use of a number of commercially available products and conventional treatment procedures. 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 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 present disclosure, or the application or use of the present disclosure. The description of the present disclosure is in many cases in the context of treating intracranial arteries, but the present disclosure can also be used in other body conduits as described above.

[0039] A common theme across many of the disclosed designs is a multi-layer structure, where in some cases the device can include an outer cage, which can sometimes include an inner cage, with both cages being directly or indirectly connected to an elongate member. Referring to FIG. 1, one exemplary device 100 according to the present disclosure is shown. The device 100 can include a cage portion 102 having a distal end 104 and a proximal end 106. The cage portion 102 can include an outer cage 108 made from a reticulated structure of outer struts 110. The cage portion 102 can include an inner cage 112 made from a reticulated structure of inner struts 114. The device 100 can include a distal clamping portion 116a positioned distally of the cage portion 102 and having a distal end 118a and a proximal end 120a. The proximal end 120a of the distal clamping portion 116a can be attached to the distal end 104 of the cage portion 102. The device 100 can include a proximal clamping portion 116b positioned proximally of the cage portion 102 and having a distal end 118b and a proximal end 120b. The distal end 118b of the proximal clamping portion 116b can be attached to the proximal end 106 of the cage portion 102. In some examples, as will be discussed in detail with respect to FIG. 2, one or more of the clamping portions 116a, 116b can be clamping cells operable to clamp, grip, or tweeze a blood clot. As discussed herein, the term "tweeze" or "tweezing" is intended to cover a clamping cell that brings the respective struts together to tweeze or grip at least a portion of a blood clot. In this regard, the number of struts in each cell need not be limited, but at least two strut surfaces must be included to tweeze the corresponding blood clot material.

[0040] Device 100 can also include an elongate member 122 having a distal end 124. The distal end 124 of the elongate member 122 can be attached to the proximal end 120b of the proximal clamping portion 116b. Additionally or alternatively, the distal end 124 of the elongate member 122 can be attached to the cage portion 102. Device 100 can include a delivery configuration within the lumen of a microcatheter, and a deployment configuration distal to the microcatheter as considered in FIG. 3 and as shown.

[0041] The elongate member 122 can be a tapered wire shaft and may be made of stainless steel, MP35N, nitinol, or other materials preferably having a high modulus of elasticity and tensile strength. The cage portion 102 and the clamping portions 116a, 116b are preferably made of a material that can automatically recover its shape when released from a strongly deformed delivery configuration. Superelastic materials such as nitinol or alloys having similar properties are particularly suitable. 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 and then heat treat and electropolish the resulting structure to create a framework of struts and connection elements. This framework can be of any of a wide variety of shapes as disclosed herein and may be visualized under fluoroscopy through the addition of alloying elements (e.g., platinum, etc.) or through various other coatings or marker bands.

[0042] FIG. 2 illustrates an enlarged view of an exemplary clamping cell 200. The clamping cell 200 can be configured to be embedded in and / or engage a blood clot and to grip the blood clot to securely hold the blood clot for retraction. It is understood that each of the clamping cells described herein can be used interchangeably with a blood clot retrieval device, as needed or desired. The clamping cell 200 includes a first collar 202, a first lumen 204, a second collar 206, and a second lumen 208, between which a clamping structure 210 can be positioned (e.g., between the first collar and the second collar). The clamping structure 210 can include strut members 212a, 212b, and 212c. One or more of the strut members 212a, 212b, and 212c can be formed or otherwise configured to include a bend that is tensioned such that it can be embedded in a blood clot and then actuated to grip and / or clamp the blood clot during use. The term "formed" is generally intended to refer to a strut that is bow-shaped, and "tension bend" is intended to refer to a strut that is placed in a tensioned state and plastically deformed into a desired shape. The clamping cell 200 can include radiopaque markers 214 disposed on one or more of the strut members.

[0043] In some examples, the clamping cell 200 can be actuated into the clamping state by being pulled by one or more tensile members, or being actuated, by being withdrawn from a sheath (e.g., a microcatheter), to deliver current to one or more of the strut members 212a, 212b, and 212c to change at least a first portion of one or more of the strut members 212a, 212b, and 212c from a folded state to a clamping state. The clamping cell 200 can be configured to embed, grip, clamp, and / or "pluck" blood clots, as shown and described more specifically in FIGS. 7A-7C. One or more of the strut members 212a, 212b, and 212c can also have one or more radiopaque bands to indicate to the user when the clamping cell 200 is clamped, since the distance between the struts decreases when the clamping cell 200 is in the expanded clamping state.

[0044] The diameter of the clamping cell 200 can range from approximately 2 to 10 millimeters, depending on need or requirement. One preferred diameter can be approximately 2.25 millimeters. In some examples, the clamping cell 200 can be small enough to fit within a 0.021 or 0.018 inch ID microcatheter. The clamping cell 200 can be constructed from a superelastic material such as nitinol, or an alloy with 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 and then heat treat and electropolish the resulting structure to create the strut framework. This framework can be made into any of a wide variety of shapes as disclosed herein and can be visualized under fluoroscopy through the addition of alloying elements (e.g., platinum, etc.) or through various other coatings or marker bands.

[0045] Referring to FIG. 3, the device 100 is shown in a delivery configuration folded within the delivery system 300. Specifically, the device 100 is in a delivery configuration within the lumen 306 of the microcatheter 302. The microcatheter 302 can have a distal end 304. Further, the clamping cell 200 can be in a folded state as will be discussed in detail in FIGS. 7A - 7C.

[0046] FIG. 4 is a flow diagram showing a method of removing a blood clot from a patient's blood vessel according to an aspect of the present disclosure. The method steps of FIG. 4 can be implemented by any of the exemplary means described herein or by similar means as will be understood. Referring to the method 400 outlined in FIG. 4, in step 402 of deploying the clamping portion of the blood clot retrieval device from a folded state to an expanded state within the blood vessel in proximity to the blood clot, the blood clot retrieval device can include a cage portion. The cage portion has a distal end, a delivery configuration within the microcatheter, and a deployed configuration distal of the microcatheter operable to retrieve at least a portion of the blood clot. The clamping portion can be positioned proximate to the distal end of the cage portion and can include a folded state and an expanded state distal of the microcatheter operable to clamp at least a portion of the blood clot. Additionally or alternatively, step 402 can include deploying the cage portion of the blood clot retrieval device from a delivery configuration to a deployed configuration within the blood clot such that the cage portion is operable to capture at least a portion of the blood clot. In step 404, it can include advancing the lumen of the microcatheter over the clamping portion such that the clamping portion is at least partially folded within the lumen of the microcatheter.

[0047] In operation 406, as the blood clot moves from the folded state to the expanded blood clot clamping state until a portion of the blood clot is compressed between the clamping portion and the microcatheter, it can include clamping the clamping portion that is in contact with a portion of the blood clot. The method can further include determining whether the blood clot is clamped. Having determined that the blood clot is clamped, the method can include withdrawing the microcatheter, the blood clot retrieval device, and the blood clot from the blood vessel while maintaining the blood clot in the blood clot clamping state of the clamping portion. Having determined that the blood clot is not clamped, the method can include deploying the cage portion of the blood clot retrieval device from the delivery configuration to the deployed configuration within the blood clot such that the cage portion is operable to capture at least a portion of the blood clot, and withdrawing the microcatheter, the blood clot retrieval device, and the blood clot from the blood vessel while the blood clot remains caught within the cage portion. Method 400 can end after operation 406. In other embodiments, additional operations according to the above-described examples can be performed.

[0048] FIG. 5 shows an exemplary blood clot removal device. Device 500 can include an inner cage 112 of a cage portion 102 consisting of one or more clamping cells 200. The cells 200 can be arranged continuously end-to-end along a common axis of the shaft 502. The cells 200 can contact each other (e.g., the distal end of the first cell 200 contacts the proximal end of the second cell 200, etc.). In other examples, the cells 200 can each be separated by a predetermined distance and / or positioned in a one-to-one ratio with the cage portion of the device 500. In some examples, more than two cells 200 can be included for each cage portion. The inner cage 112 can be within the outer cage 108. The proximal end 106 of the cage portion 102 can be operable to attach to the elongate member 122 as detailed above.

[0049] FIG. 6A illustrates an enlarged view of another exemplary clamping cell 600a having strut members 602a, 604a, and 606a shown here with undulating edges. These undulations can be formed by heat setting, crimping, or otherwise formed as needed or desired. FIG. 6B illustrates an enlarged view of another exemplary clamping cell 600b having strut members 602b, 604b, and 606b each including one or more beads. FIG. 6C illustrates an enlarged view of another exemplary clamping cell 600c having strut members 602c, 604c, and 606c shown here with relatively straight, non-curved strut members. FIG. 6D illustrates an enlarged view of another exemplary clamping cell 600d having strut members 602d, 604d, and 606d each including one or more notches or press fits. These notches or press fits can be formed by heat setting, crimping, or otherwise formed as needed or desired.

[0050] FIGS. 7A-7C show the state of the clamping cell. An exemplary expanded state of the clamping cell 200 is shown in FIG. 7A. The clamping structure 210 has an expanded diameter D1 that can be achieved distal to the distal end 304 of the microcatheter 302. An exemplary folded state of the clamping cell 200 is shown in FIG. 7B. The clamping structure 210 has a folded diameter D2 that can be achieved within the lumen 306 of the microcatheter 302. An exemplary clamped state of the expanded state of the clamping cell 200 is shown in FIG. 7C. The clamping structure 210 has a diameter that is less than the expanded diameter D1 but greater than the folded diameter D2. The ratio of the diameters can be calculated by dividing the expanded diameter D1 by the folded diameter D2. Alternatively, the ratio can be calculated by dividing the folded diameter D2 by the expanded diameter D1.

[0051] FIG. 8 shows an exemplary blood clot removal device. The device 800 can include an elongate member 122 having a cage portion 102 and a distal end 124, and the distal end 124 of the elongate member 122 can be connected to the proximal end 106 of the cage portion 102. The elongate member 122 is operable to move at least the cage portion 102 distally or proximally when the elongate member 122 is moved, and such features of the device 800 are understood to include the features, features, and designs described in U.S. Patent Nos. 8,777,976, 8,852,205, 9,402,707, 9,445,829, and 9,642,639, each of which is incorporated by reference as if set forth herein in its entirety in literal detail.

[0052] The device 800 of FIG. 8 can also include a clamping portion 802 positioned adjacent the distal end 104 of the cage portion 102. In some embodiments, the clamping portion 802, which may be elongate, has a distal end 804 and a proximal end 806. The distal end 806 of the elongate clamping portion 802 is connected to the distal end 104 of the cage portion 802. The elongate clamping portion 802 is a reticulated structure of tubular-shaped struts and can be operable to grip a blood clot. Similar to the clamping cells 200, the clamping portion 802 can have an expanded state, a folded state, and a blood clot clamping state in the expanded state, whereby the cage portion 802 can include various shapes and designs configured to clamp fibrin-rich blood clots, including those described in U.S. Patent Nos. 10,292,723, 10,363,054, U.S. Application No. 15 / 359,943, U.S. Application No. 16 / 021,505, and 16 / 330,703, each of which is incorporated by reference as if set forth herein in its entirety in literal detail.

[0053] The present disclosure is not limited to the described embodiments, which may vary in configuration and detail. The terms "distal" and "proximal" are used throughout the foregoing description and are meant to refer to a position and direction relative to the treating physician. Thus, "distal" or "distally" refers to a position away from or a direction away from the physician. Similarly, "proximal" or "proximally" refers to a position near or a direction toward the physician.

[0054] In the description of the embodiments, technical terms are used for the sake of 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 act in a similar manner to achieve a similar purpose. It should also be understood that a reference to one or more steps of a method does not exclude the presence of additional method steps or method steps intervening between those explicitly identified. Each step of a method can be performed in an order different from that described herein without departing from the scope of the disclosed technology. Similarly, a reference to one or more components of a device or system should not be understood to exclude the presence of additional components or components intervening between those explicitly identified.

[0055] As considered herein, a "patient" or "subject" can be a human or any animal. It should be understood that the animal can be of any and all applicable types, including but not limited to mammals, veterinary animals, livestock animals, or pet animals. By way of example, the animal can be an experimental animal (e.g., a rat, dog, pig, monkey, etc.) specifically selected to have certain properties similar to those of a human.

[0056] As used herein, the terms "about" or "approximately" with respect to any numerical value or range of numerical values indicate a tolerance of dimensions suitable to enable a component part or collection of components to function in accordance with its intended purpose as described herein. More specifically, "about" or "approximately" can refer to a range of values of ±20% of the recited value; for example, "about 90%" can refer to a range of values from 71% to 99%. A range can be expressed herein as from one particular value of "about" or "approximately" to another particular value of "about" or "approximately". When expressing such a range, other exemplary embodiments also include from one particular value to another particular value.

[0057] "Comprising", "containing", "including", or "having" means that at least the specified compound, element, particle, or method step is present in a composition, article, or method, but does not exclude the presence of other compounds, materials, particles, method steps, even if they have the same function as the specified ones.

[0058] It should also be noted that, as used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

[0059] The descriptions contained in this specification are examples of the present disclosure and are not intended to limit the scope of the present disclosure in any way. Although specific embodiments of the present disclosure are described, various modifications can be made to the devices and methods without departing from the scope and spirit of the present disclosure. For example, the embodiments described herein refer to specific components, but the present disclosure utilizes various combinations of components to achieve the described functionality, utilizes alternative materials to achieve the described functionality, includes other embodiments such as combining components from various embodiments and combining components from various embodiments with known components. The present disclosure contemplates replacing the component parts illustrated herein with other well-known commercially available products. For those skilled in the art related to the present disclosure, these modifications are often obvious and are intended to be within the scope of the following claims.

[0060] 〔Embodiment〕 (1) A thrombus retrieval device for retrieving a thrombus from a blood vessel, comprising: a cage portion, comprising: a distal end; a proximal end; an inner cage having a reticular structure of inner struts; an outer cage having a reticular structure of struts; wherein the inner cage and the outer cage include a delivery configuration within a microcatheter and a deployment configuration distal of the microcatheter operable to retrieve at least a portion of the thrombus, the cage portion; a distal clamping portion positioned proximate to the distal end of the cage portion; a proximal clamping portion positioned proximate to the proximal end of the cage portion; wherein each clamping portion comprises at least one clamping cell including a folded state and an expanded state distal of the microcatheter operable to pick at least a portion of the thrombus, the thrombus retrieval device. (2) The blood clot retrieval device according to Embodiment 1, wherein each clamping cell further includes a plurality of strut members, and the plurality of strut members are configured to operate to clamp the blood clot from the blood vessel between the plurality of strut members. (3) The blood clot retrieval device according to Embodiment 2, wherein the plurality of strut members are positioned around a central strut member of the plurality of strut members, and each strut member is joined at a common respective proximal end and distal end. (4) The blood clot retrieval device according to Embodiment 2, wherein each clamping cell is operable to pick up the blood clot when moving from the folded state to the expanded blood clot clamping state until a portion of the blood clot is compressed between the plurality of strut members. (5) The blood clot retrieval device according to Embodiment 2, including a ratio of the diameter of each clamping cell between the folded state and the expanded state, which is approximately 1.5:1 to 4:1.

[0061] (6) The blood clot retrieval device according to Embodiment 2, wherein each clamping cell includes a radiopaque marker disposed on the plurality of strut members. (7) Each clamping cell a clamping structure including a plurality of strut members and a central strut member of the plurality of strut members; a first collar having a first collar lumen; and a second collar having a second collar lumen, and further includes The blood clot retrieval device according to Embodiment 1, wherein the plurality of strut members and the central strut member connect the first collar to the second collar. (8) The blood clot retrieval device according to Embodiment 1, wherein the inner cage is a plurality of clamping cells operable to pick up at least a portion of the blood clot. (9) Each cell of the plurality of clamping cells a clamping structure including a plurality of strut members and a central strut member of the plurality of strut members; a first collar having a first collar lumen; and a second collar having a second collar lumen, and further includes The blood clot retrieval device according to embodiment 8, wherein the plurality of strut members and the central strut member connect the first collar to the second collar. (10) The blood clot retrieval device according to embodiment 9, wherein the plurality of clamping cells comprise at least one radiopaque marker disposed on the clamping structure.

[0062] (11) The blood clot retrieval device according to embodiment 8, wherein each cell of the plurality of clamping cells further includes the folded state and the expanded state at the distal end of the microcatheter operable to pick at least a portion of the blood clot. (12) The blood clot retrieval device according to embodiment 1, further comprising an elongated member having a distal end connected to the proximal end of the proximal clamping portion, the elongated member being operable to move the blood clot retrieval device in a distal or proximal direction. (13) The blood clot retrieval device according to embodiment 1, wherein the reticulated structure of the struts is connected to the reticulated structure of the inner struts. (14) A method for retrieving a blood clot, comprising: deploying, within a blood vessel, a clamping portion of a blood clot retrieval device from a folded state to an expanded state in proximity to the blood clot, the blood clot retrieval device comprising a cage portion, the cage portion comprising a distal end, a delivery configuration within a microcatheter, and a deployment configuration at the distal end of the microcatheter operable to retrieve at least a portion of the blood clot, the clamping portion being positioned proximate to the distal end of the cage portion and including the folded state and the expanded state at the distal end of the microcatheter operable to clamp at least a portion of the blood clot, a step of deploying; advancing the lumen of the microcatheter over the clamping portion such that the clamping portion is at least partially folded within the lumen of the microcatheter; clamping the clamping portion in contact with the portion of the blood clot as it moves from the folded state to the expanded blood clot clamping state until a portion of the blood clot is compressed between the clamping portion and the microcatheter. (15) The method further includes determining that a portion of the blood clot is clamped, while maintaining the blood clot in the blood clot clamping state of the clamping portion, pulling out the micro catheter, the blood clot recovery device, and the blood clot from the blood vessel, the method according to embodiment 14.

[0063] (16) The method further includes determining that a portion of the blood clot is not clamped, deploying the cage portion of the blood clot recovery device from the delivery configuration to the deployed configuration within the blood clot such that the cage portion is operable to capture at least a portion of the blood clot, while the blood clot remains caught within the cage portion, withdrawing the micro catheter, the blood clot recovery device, and the blood clot from the blood vessel, the method according to embodiment 14. (17) The clamping portion includes a clamping structure including a plurality of strut members and a central strut member of the plurality of strut members, a first collar having a first collar lumen, a second collar having a second collar lumen, and further includes the plurality of strut members and the central strut member connecting the first collar to the second collar, the method according to embodiment 14. (18) A method for recovering a blood clot, comprising deploying, within a blood vessel and proximate to the blood clot, a clamping portion of a blood clot recovery device from a folded state to an expanded state, the clamping portion being located proximate to a distal end of a cage portion of the blood clot recovery device, the clamping portion including the folded state within the micro catheter and the expanded state at the distal end of the micro catheter operable to clamp at least a portion of the blood clot, the deploying step Deploying the cage portion of the blood clot retrieval device within the blood vessel, adjacent to the blood clot, from a delivery configuration to a deployed configuration, the cage portion including the deployed configuration distal to the microcatheter and being operable to recover at least a portion of the delivery configuration within the microcatheter and the blood clot. Advancing the lumen of the microcatheter over the clamping portion such that the clamping portion is at least partially folded within the lumen of the microcatheter. Clamping the clamping portion in contact with the portion of the blood clot as it moves from the folded state to the expanded blood clot clamping state until a portion of the blood clot is compressed between the clamping portion and the microcatheter. Retracting the microcatheter, the blood clot retrieval device, and the blood clot from the blood vessel while the blood clot is clamped by the clamping portion. A method comprising. (19) The blood clot retrieval device is A proximal clamping portion positioned adjacent to the proximal end of the cage portion, the proximal clamping portion including a proximal clamping portion having a proximal end. An elongated member having a distal end connected to the proximal end of the clamping portion, the elongated member being operable to move the blood clot retrieval device in a distal or proximal direction. The method according to embodiment 18, further comprising. (20) The clamping portion is A clamping structure including a plurality of strut members and a central strut member of the plurality of strut members. A first collar having a first collar lumen. A second collar having a second collar lumen. Further comprising The plurality of strut members and the central strut member connecting the first collar to the second collar. The method according to embodiment 18.

Claims

1. A blood clot retrieval device for retrieving a blood clot from a blood vessel, comprising: a cage portion, a distal end, a proximal end, an inner cage having a reticular structure of inner struts, an outer cage having a reticular structure of struts, the inner cage and the outer cage including a delivery configuration within a microcatheter and a deployment configuration distal of the microcatheter operable to retrieve at least a portion of the blood clot; a distal clamping portion positioned proximate the distal end of the cage portion; a proximal clamping portion positioned proximate the proximal end of the cage portion; each of the distal clamping portion and the proximal clamping portion comprising at least one clamping cell including a folded state and an expanded state distal of the microcatheter operable to pinch at least a portion of the blood clot; each clamping cell further comprising at least three plural strut members configured to actuate to clamp the blood clot from the blood vessel between the plural strut members; the plural strut members being positioned around a central strut member of the plural strut members, each strut member being joined only at respective common proximal and distal ends, a blood clot retrieval device.

2. The blood clot retrieval device according to claim 1, wherein each clamping cell is operable to pinch the blood clot upon movement from the folded state to the expanded blood clot clamping state until a portion of the blood clot is compressed between the plural strut members.

3. The blood clot retrieval device according to claim 1, wherein each clamping cell includes a ratio of diameters of each clamping cell between the folded state and the expanded state of approximately 1.5:1 to 4:

1.

4. The blood clot retrieval device according to claim 1, wherein each clamping cell comprises a radiopaque marker disposed on the plural strut members.

5. Each clamping cell further comprises: a first collar having a first collar lumen; a second collar having a second collar lumen; the plural strut members and the central strut member connecting the first collar to the second collar, the blood clot retrieval device according to claim 1.

6. The blood clot retrieval device according to claim 1, wherein the inner cage is a plurality of clamping cells operable to pinch at least a portion of the blood clot.

7. Each cell of the plurality of clamping cells, A clamping structure including a plurality of strut members and a central strut member among the plurality of strut members, A first collar having a first collar lumen, A second collar having a second collar lumen, and further comprising: The blood clot retrieval device according to claim 6, wherein the plurality of strut members and the central strut member connect the first collar to the second collar.

8. The blood clot retrieval device according to claim 7, wherein the plurality of clamping cells include at least one radiopaque marker disposed on the clamping structure.

9. The blood clot retrieval device according to claim 6, wherein each cell of the plurality of clamping cells further includes the folded state and the expanded state at the distal end of the microcatheter operable to pick at least a portion of the blood clot.

10. The blood clot retrieval device according to claim 1, further comprising an elongated member having a distal end connected to the proximal end of the proximal clamping portion, the elongated member being operable to move the blood clot retrieval device in a distal or proximal direction.

11. The blood clot retrieval device according to claim 1, wherein the reticulated structure of the struts is connected to the reticulated structure of the inner struts.

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