A blood clot removal device for removing blood clots from blood vessels.

Abstract

To provide a clot removal device.SOLUTION: The clot removal device includes an expandable structure comprising interconnected struts configured to engage with a clot. The interconnected struts are configured in the expanded clot engaging deployed configuration such that at least a portion of the plurality of interconnected struts interpenetrates the clot. The expandable structure includes a distal section, a proximal pinch section proximal to the distal section, and a clot capture mechanism.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] Thrombus retrieval devices are used for mechanical thrombus removal in endovascular interventions, particularly when a patient suffers from acute ischemic stroke (AIS), myocardial infarction (MI), pulmonary embolism (PE), etc. Acute occlusions can include thrombi, misplaced devices, migrated devices, large emboli, etc. Embolism occurs when part or all of a thrombus detaches from the vessel wall. This thrombus (herein referred to as an embolus) is then carried in the direction of blood flow. Ischemic stroke can result when a thrombus occludes the blood vessels in the brain. Pulmonary embolism can result when a thrombus develops in the venous system or on the right side of the heart and occludes in the pulmonary artery or its branches. A thrombus can also develop in the form of an embolus without being released and locally occlude a blood vessel, and this mechanism is common in the formation of obstructions in the coronary arteries. There are significant challenges associated with the design of thrombus removal devices that can provide a high level 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 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 serious in arteries approaching the brain. For example, it is not uncommon for the device to have to advance uninterrupted over several centimeters of vessels with 180° bends, 90° bends, and 360° bends in the distal end of the internal carotid artery. 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 rigid or high-profile devices. For these reasons, it is desirable that blood clot retrieval devices be compatible with guide catheters that are as low-profile and flexible as possible.

[0004] Secondly, vascular structures within areas where blood clots may be present are often fragile and delicate. For example, neurovascular vessels are more fragile than vessels of similar size in other parts of the body and are located in a soft tissue bed. Excessive tensile force applied to these vessels can lead to perforation and bleeding. Pulmonary vessels are larger than those of the cerebrovascular system, but are also inherently more delicate, especially the more distal pulmonary vessels.

[0005] Thirdly, blood clots can encompass a range of morphological and stylistic characteristics. For example, blood clots may be difficult to grasp, and improper grasping can lead to fragmentation that can cause embolism. Longer, string-like, softer blood clots also tend to clog at bifurcations or trifurcations, resulting in the simultaneous occlusion of multiple blood vessels over considerable lengths. More mature and organized blood clots may be less compressible than softer, newer clots, and under the action of blood pressure, they can expand the flexible blood vessels they occupy. Furthermore, the inventors have found that the properties of blood clots can be significantly altered by the action of devices interacting with them. Specifically, compression of a blood clot causes dehydration, resulting in a dramatic increase in both the stiffness and friction coefficient of the clot.

[0006] Any device must overcome the aforementioned challenges to achieve a high level of success in removing blood clots and restoring blood flow. Existing devices do not adequately address these challenges, particularly those associated with vascular trauma and blood clot characteristics. [Overview of the project] [Means for solving the problem]

[0007] The objective of this design is to provide a device and method that meets the above needs. Therefore, it is desirable that the blood clot retrieval device removes blood clots from the cerebral arteries of patients suffering from AIS, from the natural coronary or transplanted vessels of patients suffering from MI, from the pulmonary arteries of patients suffering from pulmonary embolism, and from other peripheral arteries and veins where the blood clot is causing occlusion.

[0008] In some examples, a clot removal device for removing blood clots from blood vessels is disclosed. The device may include an expandable structure that includes interconnected struts configured to engage with a blood clot, and includes a constrained delivery configuration and an extended clot engagement deployment configuration. The interconnected struts may be configured such that, in the clot engagement deployment configuration, at least some of the interconnected struts mutually penetrate with the blood clot. The expandable structure may include a distal portion, and a proximal pinch portion may be included proximal to the distal portion. The proximal pinch portion may be configured to pinch the blood clot during operation from the extended clot engagement deployment configuration to at least a partially constrained clot gripping configuration. The clot capture mechanism may include a proximal end, a distal end, a shaft extending from the proximal end and distally from the proximal end of the proximal pinch portion, and a capture member extending from the distal end of the shaft into the distal portion.

[0009] In some examples, the capturing member may include a proximal opening.

[0010] In some examples, the shaft may include a curve and / or pitch equivalent to that of the pinch section.

[0011] In some examples, the capturing member may terminate at the distal end of the distal portion, or adjacent to that distal end.

[0012] In some examples, the capturing member may terminate at the proximal end of the distal portion, or adjacent to that proximal end.

[0013] In some examples, the extensible structure may include an open distal end.

[0014] In some cases, the proximal pinch portion may be non-cylindrical and have a smaller diameter than the distal portion.

[0015] In some examples, the proximal opening may include a support frame that forms a self-expandable fragment-capturing net coupled to the support frame.

[0016] In some examples, the proximal opening can be formed by a proximal opening structure having a diameter approximately equal to the diameter of the distal portion. The proximal opening structure may include a fragment protection member having closure cells smaller than those of the distal and proximal pinch portions, and the most distal end of the proximal opening structure is positioned at the distal end of the distal portion.

[0017] In some examples, the proximal end of the capturing member can be positioned where the proximal pinch portion contacts the distal portion or in its vicinity.

[0018] In some examples, the proximal end of the capturing member can be positioned distal to the point where the proximal pinch portion contacts the distal portion.

[0019] In some examples, the proximal end of the capturing member can be positioned proximal to the point where the proximal pinch portion contacts the distal portion.

[0020] In some examples, the proximal pinch can be configured such that, when folded with multiple interconnected struts interpenetrating the blood clot, at least a portion of the proximal pinch holds at least a portion of the blood clot.

[0021] In some examples, the capture member can be axially fixed relative to the proximal pinch and / or the distal portion.

[0022] In some examples, the capture member can include a closed-cell fragment protection strut structure having a porosity smaller than the porosity of the proximal pinch and / or the distal portion.

[0023] In some examples, the distal portion can include a distal barrel portion that flares outward to form a barrel shape having an open distal end, and the interconnected struts can include at least a plurality of proximally facing struts and a plurality of distally facing struts. At least some of the lengths of the proximally facing struts can be longer than at least some of the lengths of the distally facing struts, thereby varying the outward radial force of the device in an expanded blood clot engaging deployment configuration.

[0024] In some examples, the shaft and the proximal pinch of the blood clot capture mechanism can have a helical shape including a helical pitch in the range of about 10 - 25 mm.

[0025] In some examples, the longitudinal axis can extend through the distal portion. The shaft and the proximal pinch of the blood clot capture mechanism can extend helically around the longitudinal axis.

[0026] In some examples, the distal barrel portion includes distal radiopaque markers attached to at least two of the most distal ends of the interconnected struts forming the distal barrel portion.

[0027] In some examples, a plurality of radiopaque markers can be disposed at the transition between the proximal pinch and the distal barrel portion.

[0028] In some examples, the proximal pinch portion can include a blood clot engaging element configured to exert an outward radial force when deployed within a blood vessel having an inner diameter smaller than the inner diameter of the expanded deployment configuration. The blood clot engaging element can be configured to exert an outward radial force that varies in a substantially sinusoidal pattern along the length of the blood clot engaging element.

[0029] In some examples, the substantially sinusoidal pattern has a wave pattern with an amplitude that decreases along the length of the proximal pinch portion, and this amplitude can be higher at the proximal end of the blood clot engaging element and lower at the distal end.

[0030] In some examples, generally the sinusoidal pattern can include a wave pattern. The elongated member can also include a proximal end and a distal end, and the distal end is connected to the proximal end of the expandable structure. The proximal junction can be disposed between the elongated member and the expandable structure, and the proximal junction includes a step at the distal end of the elongated member.

[0031] In some examples, the distal portion included an inner expandable body having a strut framework. The outer expandable body can be included with a strut framework that forms an outer body that radially surrounds the inner body between the folded delivery configuration and the expanded deployment configuration. The outer expandable body can be expandable in a radial extent to define a blood clot containment space.

[0032] In some embodiments, the strut framework of the outer expandable body can include a plurality of discontinuous expandable members spaced apart from adjacent expandable members, and each expandable strut forms a closed cell having at least some struts that terminate at a radially separated distal tip not connected to an adjacent closed cell.

[0033] In some examples, the inner expandable body can include a porous inner body flow path.

[0034] In some examples, the internally expandable body may include a first scaffold segment containing a plurality of closure cells and a second scaffold segment having a plurality of closure cells and located distal to the first scaffold segment. The internal body may extend inside the first and second scaffold segments. A blood clot inlet may be located between the first and second scaffold segments to receive a blood clot or fragment thereof.

[0035] In some examples, the blood clot inlet can be detached from the scaffold and may include an opening larger than any of the multiple cells of the first and second scaffold segments.

[0036] In some cases, the blood clot inlet is cut between the first scaffolding segment and the second scaffolding segment over a circumferential arc of approximately 180 degrees, or a cut can otherwise be formed.

[0037] In some examples, the device may include an open distal end.

[0038] In some cases, the proximal pinch portion can have a larger diameter than the distal portion.

[0039] In some cases, the proximal pinch may be substantially planar or linear, or it may be elongated.

[0040] In some cases, the proximal pinch portion may be cylindrical.

[0041] In some cases, the proximal strut of the lateral expandable body can pass through one or more cells in the proximal pinch region.

[0042] In some examples, the proximal strut of the lateral expandable body is located both internally and externally to the proximal pinch portion.

[0043] In some examples, the distal portion may include an internally expandable body containing a porous internal body channel.

[0044] In some examples, the capture member may include an outer expandable body comprising a framework of struts that form an outer body radially surrounding the distal portion while in a folded delivery form and an extended unfolded form, the outer expandable body being expandable radially to define a blood clot receiving space between it and the distal portion.

[0045] In some examples, the externally expandable body may include a closed distal end and at least one scaffolding segment proximal to the closed distal end. The at least one scaffolding segment may contain multiple closed cells, and the distal portion may extend inward of the at least one scaffolding segment.

[0046] In some examples, the strut framework of the outer expandable body may consist of multiple discontinuous expandable members that form a closure cell having at least some struts terminating at radially separated distal apex portions that are not connected to adjacent closure cells.

[0047] In some examples, the closed end can be formed by a distal scaffolding zone containing multiple struts that taper distally with smaller closing cells than the proximal cells within the outer expandable body.

[0048] In some examples, multiple closed cells in the distal scaffolding zone can include protective strut structures.

[0049] In some examples, the distal portion comprises an internally expandable body including a porous internal body channel terminated by a plurality of distal struts, each distal strut having a first end coupled to the distal end of the porous internal body channel and a second end coupled to one another to form a connection point.

[0050] In some cases, multiple distal struts are spiral-shaped.

[0051] In some cases, multiple distal struts are composed of a bulging or spreading pattern.

[0052] In some examples, the distal portion includes an internally expandable body containing a porous inner body channel that terminates with one or more distal struts to define a protective strut structure configured to prevent blood clots or blood clot fragments from exiting distally from the device. The protective strut structure may have a diameter larger than the diameter of the porous inner body channel and is positioned at or adjacent to the closed distal end of the capture member.

[0053] In some examples, methods for capturing blood clots are disclosed. These methods include extending an expandable structure of any device of the disclosure until it is in contact with at least a portion of the blood clot, grasping at least a portion of the blood clot with a proximal pinch, and capturing one or more fragments of the blood clot with a blood clot capture mechanism.

[0054] Other aspects and features of this disclosure will become apparent to those skilled in the art by considering the following detailed description in conjunction with the accompanying figures. [Brief explanation of the drawing]

[0055] The above and further aspects of this disclosure will be further considered in conjunction with the following description of the accompanying drawings, where similar figures in various drawings indicate similar structural elements and features. The drawings are not necessarily to scale, and instead, emphasis is placed on illustrating the principles of this disclosure. The figures depict one or more implementations of the device of the present invention, merely as examples and not as limitations. Those skilled in the art will anticipate that elements from multiple drawings can be conceived and combined to better suit the user's needs. [Figure 1] An isometric view of the apparatus according to this disclosure is shown. [Figure 2A] This is an isometric view of the fragment protection member according to this disclosure. [Figure 2B] This is an isometric view of the pinch member according to this disclosure. [Figure 3] An isometric view of the apparatus according to this disclosure is shown. [Figure 4A] This is an isometric view of the fragment protection member according to this disclosure. [Figure 4B] This is an isometric view of the pinch member according to this disclosure. [Figure 5] This is an isometric view of the apparatus according to the present disclosure. [Figure 6A] This is an isometric view of the pinch member according to this disclosure. [Figure 6B] This is an isometric view of the outer member related to this disclosure. [Figure 7A] This is an isometric view of the apparatus according to the present disclosure. [Figure 7B] This is an isometric view of the apparatus according to the present disclosure. [Figure 8A] This disclosure shows one step in the method of using the blood clot removal device. [Figure 8B] This disclosure shows one step in the method of using the blood clot removal device. [Figure 9A] This disclosure shows one step in the method of using the blood clot removal device. [Figure 9B] This disclosure shows one step in the method of using the blood clot removal device. [Figure 10] This disclosure shows one step in the method of using the blood clot removal device. [Figure 11] This flowchart illustrates a method for removing a blood clot from a patient's blood vessel according to the embodiments of this disclosure. [Modes for carrying out the invention]

[0056] Specific embodiments of this disclosure are described in detail herewith reference to the drawings, where the same reference numerals indicate functionally similar or identical elements. The embodiments address many of the shortcomings associated with conventional catheters, such as inefficient blood clot removal and inaccurate deployment of the catheter to the target site.

[0057] Accessing various blood vessels within the vascular system, whether coronary, pulmonary, or cerebral, involves well-known procedures and the use of numerous conventional commercially available accessory products. These products, such as angiographic materials and guidewires, are widely used in diagnostic and medical procedures. Where these products are used in conjunction with the systems and methods of this disclosure in the following description, their functions and exact configurations are not described in detail.

[0058] The following detailed descriptions are illustrative in nature and are not intended to limit the Disclosure or its applications and uses. While the descriptions in the Disclosure are often in connection with procedures on intracranial arteries, the Disclosure may also be used in other body passages as described above.

[0059] Specific embodiments of this disclosure have been illustrated and described, but it will be apparent from the above description that various modifications can be made without departing from the spirit and scope of this disclosure. For example, while embodiments described herein refer to certain features, this disclosure includes embodiments having different combinations of features. This disclosure also includes embodiments that do not include all of the specific features described. Specific embodiments of this disclosure are described in detail hereafter 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 location or direction relative to the treating physician. “Distal” or “distal” means a location away from the physician or in a direction away from the physician. “Proximal” or “proximal” or “near” means a location close to the physician or in a direction toward the physician.

[0060] Accessing the cerebrum, coronary arteries, and pulmonary veins involves the use of numerous commercially available products and conventional procedure 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 this disclosure and do not necessarily need to be described in detail.

[0061] The following detailed descriptions are illustrative in nature and are not intended to limit the Disclosure or its applications and uses. While the descriptions in the Disclosure are often in connection with procedures on intracranial arteries, the Disclosure may also be used in other body passages as described above.

[0062] A common theme across many of the disclosed designs is a multilayer structure in which, in certain cases, the device may include a proximal pinch member, which may sometimes include a fragment protection member, and / or other elements to facilitate blood clot capture, thereby allowing such members to be directly or indirectly connected to an elongated shaft. Referring to Figure 1, an example device 1000 according to the present disclosure is shown. Member 1020 includes a proximal pinch portion 1021 and a distal barrel portion 1022. The device 1000 may include a fragment protection member 1050, which is located inside the barrel portion 1022, as described in more detail in Figure 2A, and can improve the effectiveness of fragment protection.

[0063] The distal radiopaque marker 1025 can be positioned between the pinch portion 1021 and the barrel portion 1022 and can be included in one or more distal crowns 1024. The crowns 1024 can be separated from the distal apex. In this case, the proximal pinch portion 1021 can be heat-fixed into a helical shape (e.g., a helix centered on axis A1 as shown in Figure 2B). The helix can have a helical pitch of about 14 mm (in the range of about 10 to 25 mm) and an outer diameter of the helix of about 5 mm (in the range of 4.0 to 10 mm) (e.g., diameter D1 in Figure 2B), and the helix can typically form a curve of about 360°, or a curve in the range of about 180 to 720°. The diameter D2 of the barrel portion 1022 can be smaller than the diameter D1 of the pinch portion 1021. However, the apparatus 1000 is not limited in this way, and instead, the diameter D2 may be equal to and / or greater than the diameter D1, as needed or required.

[0064] The pinch portion 1021 may include a ring of cells 1023, which may include circumferential cells. The number of cells in the circumferential ring can vary from 2 to 5, but in a preferred embodiment, there are 3 or 4 cells. The portion 1026 of the device 1000 between cells 1023 (e.g., embedded cells) may have low radial force and low level scaffolding. Low level scaffolding is achieved by minimizing the area in this region 1026 over which surface contact is possible between the struts of the device and the blood clot. In this embodiment, the connecting strut 1027 can be curved toward the centerline at an intermediate position to further reduce the contact force and area of ​​the struts with respect to the blood clot. This small surface contact area and radial force allow the blood clot to protrude into this portion of the device 1000 when it unfolds within an occlusive blood clot. By partially re-covering the device 1000 with a microcatheter or intermediate catheter, the protruding blood clot can be trapped between the tip of the catheter and the proximal strut 1026 of the implantation ring of cell 1023.

[0065] The longitudinal axis A2 of the distal barrel section 1022 may be offset from the helix to help achieve a uniform (low-strain) connection between the sections. In this apparatus 1020, the distal end of the helix can be positioned perpendicular to the proximal surface of the barrel section 1022. In this arrangement, both struts connecting the helix to the barrel section 1022 are of equal length and have equivalent levels of strain regardless of the position of the cutting pattern on the thermoforming mandrel. In other iterations, the helix may be positioned at an angle to the barrel section 1022.

[0066] The pinch portion 1021 may include cells, struts, and various shapes and designs configured to hold fibrin-rich blood clots, including those described in U.S. Patent Nos. 10,292,723, 10,363,054, U.S. Patent Applications Nos. 15 / 359,943, 16 / 021,505, and 16 / 330,703. Compression of a blood clot by member 1020 (e.g., by the pinch portion 1021), as described in International Publication No. 2012 / 120490(A), the entire content of which is incorporated herein by reference, may alter the properties of the blood clot, making it harder and "more sticky," thereby making it more difficult to recover.

[0067] In some, but not limited to, cases in which a microcatheter is advanced distally to a device 1000 that includes a pinch section 1021 (Figure 2c) that enhances the gripping of blood clots and the protection of captured blood clot segments, the blood clot can be compressed between the catheter tip and the strut of the device 1000. The user can sense this gripping as resistance and advance the microcatheter, or alternatively, the user can advance the microcatheter a certain distance relative to the device 1000 (e.g., 30% to 50% of the device's length) and then retract both the device 1000 and the microcatheter together. This process is clearly illustrated in Figures 8A to 10.

[0068] The relative tension between the device 1000 and the microcatheter must be maintained to ensure that the clamping between the device 1000 and the blood clot does not decrease. By retracting both the device 1000 and the microcatheter, the occlusive blood clot can be removed and retracted, entering the access guide catheter or introducer sheath and removed from the patient. This disclosure is particularly well suited to removing blood clots with high fibrin content (typically more than 40% fibrin content) and other blood clots that are difficult to remove and recover with known stent retriever designs and which may currently require multiple passes to remove the blood clot from the vascular structure. This disclosure may also induce clamping of the blood clot by advancing the intermediate catheter in the same manner as described herein with respect to the microcatheter.

[0069] The apparatus 1000 of this disclosure is intended to facilitate the retrieval of a blood clot by engaging with the clot over its entire surface area by expanding between the clot and the vessel wall, and such engagement is achieved with minimal compression of the clot. In some embodiments, gripping can be achieved by advancing a microcatheter or intermediate catheter against the apparatus until a portion of the clot is compressed between the catheter and member 1020. However, the operation of member 1020 is not limited to this and can also be performed by pulling one or more tension members attached thereto, thereby sending an electric current to one or more of the strut members of member 1020 to change it from a folded state to a pinched state. This gripping increases the gripping force of the apparatus 1000 against blood clots, particularly fibrin-rich clots, thus facilitating clot removal. This can also stretch the clot, reducing the force required for movement by pulling the clot away from the vessel wall during the movement process.

[0070] The device 1000 may have an elongated shaft 1006 having a distal end extending into the artery and a proximal end extending outside the artery. The shaft 1006 may be a tapered wire shaft and may be made of stainless steel, MP35N, nitinol, or other materials preferably with high modulus of elasticity and tensile strength. The shaft 1006 may have an indicator band 1007 to indicate that the distal end of the device 1000 is approaching the end of the microcatheter during insertion. The shaft 1006 may have a coil 1004 adjacent to its distal end. The coil 1004 may be metal and may be formed from stainless steel, or from a more radiopaque material such as platinum or gold, or an alloy of such materials. In another embodiment, the coil 1004 may be coated with a low-friction material or may have a polymer jacket disposed on the outer surface of the coil 1004.

[0071] A sleeve 1005 may be positioned on the shaft 1006 adjacent to the coil 1004. The sleeve 1005 may be made of a polymer and may be positioned on the tapered portion of the shaft 1006. The sleeve 1005 can be made radiopaque by adding a filler material such as tungsten or barium sulfate. However, other radiopaque materials can be conceivable, including but not limited to bismuth subcarbonate, barium oxychloride, gold, platinum, iridium, tantalum, or alloys of any of these materials. The sleeve 1005 and shaft 1006 may be coated with a material to reduce friction and thrombosis. The coating may include polymers, low-friction lubricants such as silicon, and hydrophilic or hydrophobic coatings. This coating may also be applied to the apparatus 1000.

[0072] Figure 2A is an isometric view of the fragment protection member 1050 without the member 1020 of the present disclosure. Similarly, Figure 2B is an isometric view of the member 1050 of the present disclosure without the member 1020. The member 1050 may include a wire 1056 connecting the fragment protection member 1050 to the proximal joint 1058. The leading edge 1057 of the fragment protection structure 1055 may be positioned inside the barrel portion 1022, aligned with and / or substantially adjacent to the distal crown 1024, as shown in Figure 1. In one example, the distal end 1059 of the member 1050 may have the same spread as the crown 1024. The member 1050 may also be fixedly positioned within the barrel portion 1022, or it may be movable between one or more predetermined positions, as needed or required. The member 1050, positioned as illustrated and described, is particularly advantageous for capturing blood clot fragments by the smaller mesh size cells of the structure 1055 without affecting the pinching capability of the pinch section 1021. The structure 1055 and corresponding elements shown in Figure 2A can be attached to a wire 1056, which may be a shaft having the same or similar helical curvature and pitch as the pinch section 1021. As illustrated, the member 1050 includes various net or basket designs for catching any fragments that may be released from the body of the blood clot. The anti-fragmentation function of the member 1050, located at the distal end of the device 1000, which minimizes the risk of distal embolism during the declotting procedure, is also disclosed.

[0073] Referring to Figure 3, another apparatus 2000 according to the present disclosure is shown. Similar to apparatus 1000, apparatus 2000 can be mounted on a shaft 1006 and may include a pinch member 2020, a distal portion 2022 extending distally from the member 2020, and a fragment protection member 2050 positioned inside the distal portion 2022. The distal portion 2022 can be understood to incorporate some or all features of the blood clot removal devices described in U.S. Patents No. 8,777,976, No. 8,852,205, No. 9,402,707, No. 9,445,829, No. 9,642,639, No. 10,292,722, No. 10,299,811, No. 10,588,649 and No. 10,610,246, which are incorporated herein as if they were described in their entirety. The pinch member 2020 may include a proximal pinch portion 2021 which is substantially the same as the pinch portion 1021. The fragment protection member 2050 is clearly shown in Figure 4A, while member 2020 is clearly shown in Figure 4B.

[0074] In Figure 4A, member 2050 may include a wire 2056, similar to wire 1056, that connects the fragment protection member 2050 to the proximal joint 2058. The leading edge 2057 of the fragment protection structure 2055 may be positioned inside the distal portion 2022 (e.g., member 2102) shown in Figure 3, aligned with and / or substantially adjacent to the distal crown of the distal portion 2022. In one example, the distal end 2059 of member 2050 may have the same spread as the crown 2134 of the distal portion 2022. Member 2050 may also be fixedly positioned within the distal portion 2022, or may be movable between one or more predetermined positions, as needed or required. Member 2050, positioned as illustrated and described, is particularly advantageous for capturing fragments of blood clots by the smaller mesh size cells of the structure 2055 without affecting the pinching ability of the pinch portion 2021 and / or the blood clot capture by the distal portion 2022. The structure 2055 and its corresponding elements shown in Figure 4A can be attached to wire 2056, which may be a shaft having the same or similar helical curvature and pitch as the pinch portion 2021, as can be wire 1056.

[0075] The distal portion 2022 may extend distally from the connecting strut 2027 and may include an outer expandable member 2102 and an inner expandable member 2103 to facilitate the recovery of blood flow through the blood clot immediately after the device 2100 is deployed at the occlusion site. Member 2103 is configured to self-expand to a diameter greater than the diameter of member 2102 upon release from the restraining sheath (e.g., a microcatheter). Members 2102 and 2103 may specifically have a folded form for delivery and an expanded form for blood flow recovery and fragmentation protection. Members 2102 and 2103 may be joined at their proximal and distal ends while assembled to minimize tension within members 2102 and 2103 during use. In other embodiments, member 2103 may not be connected at all to the distal end of member 2103, or may be restrained within member 2102 without being fixedly attached.

[0076] The expansion of member 2102 can cause compression and / or movement of the blood clot during expansion. When the expandable body provides a high level of support, the blood clot is compressed. When the expandable body provides an escape route or opening, the expanding body biases the blood clot toward the opening. However, if the expandable body provides only a moderate level of support, the blood clot is moved, but because the blood clot has multiple degrees of freedom, it can move in various different directions and is therefore uncontrollable. By providing a tubular expandable body whose length is substantially longer than the length of the occlusive blood clot, many of the available degrees of freedom of movement for the blood clot are eliminated.

[0077] As shown in the figure, member 2102 may include two expandable members of member 2102. However, any number of expandable members may be used with the distal portion 2022. Members 2102 and 2103 have a folded form for delivery and an expanded form associated with member 2050 for clot retrieval, blood flow restoration, and fragmentation protection. In some examples, member 2103 may have a substantially tubular body portion. In other embodiments, member 2103 may have a non-cylindrical cross-section, which may have a non-uniform diameter and may have a strut pattern adjusted to provide different radial force or flexibility regions. Member 2103 may be configured to provide a flow lumen or channel (e.g., a substantially cylindrical cross-section) through the distal portion 2022 to facilitate the restoration of blood flow through the clot upon deployment. In one embodiment, member 2103 is configured to provide a scaffold in the channel through the clot to prevent the release of fragments that might otherwise become lodged in the distal vascular structure. The length of member 2102 may be substantially the same as the length of member 2103 in both the freely extended and loaded and folded configurations. Members 2102 and 2103 are preferably made of a superelastic or pseudoelastic material, such as nitinol or another alloy having high recoverable strain.

[0078] An inlet opening 2122 is provided in member 2102, so that the inlet 2122 can provide a primary degree of freedom of movement available to the blood clot, and as member 2102 expands, the blood clot is driven toward the receiving space 2111. Member 2102 may have multiple inlet openings 2122 for receiving the blood clot. The inlet openings 2122 can be configured to allow a portion of the blood clot to enter the receiving space 2111, and thereby allow the blood clot to be recovered without excessive compression. This is advantageous because the inventors have found that compressing a blood clot causes dehydration, which in turn increases the frictional properties and rigidity of the blood clot, making it difficult to detach and remove the blood clot from the blood vessel. This compression can be avoided because, as the blood clot moves inward through the wall of member 2102, the porous structure moves outward toward the blood vessel wall.

[0079] The inlet opening 2122 can also provide an additional benefit by allowing member 2102 to apply a force to the blood clot in a direction substantially parallel to the direction in which the blood clot is pulled from the vessel (i.e., substantially parallel to the central axis of the vessel) when it retracts. This means that outward radial forces applied to the vascular structure (e.g., as indicated by the arrows in Figures 9A and 9B) can be kept to a minimum, and consequently, the action that the distal clot retrieval portion 2022 applies to the blood clot does not increase the force required to remove the blood clot from the vessel, thus protecting the delicate cerebral blood vessels from harmful radial and tensile forces.

[0080] As shown in the figure, members 2102 may include proximal struts (e.g., struts 22144, 2155) that are connected to the pinch portion 2021 at their proximal ends and to the first expandable member 2126 at struts 2027 positioned adjacent to or tangent to the distal end of the pinch portion 2021. As shown in the figure, struts 22144, 2155 may have a tapered contour to ensure a gradual change in stiffness from the pinch portion 2021 toward the blood clot engagement portion of the distal portion 2022. Member 2126 may be connected to the second expandable member 2127 by a plurality of connecting arms 2129 that can extend from the proximal joint 2139 toward the distal joint 2140. The arms 2129 may include generally linear struts that extend parallel to the central axis of the device. In other embodiments, these connecting arms may comprise multiple struts configured in one or more cells, or they may comprise curved or helical arms. The region between the first expandable member and the second expandable member has two inlet openings 2122 through which blood clots can pass and enter a receptive space 2111 defined by the region between the inner and outer members. The segmentation and hinge design of the struts between member 2126 and member 2127 are also specifically adjusted so that they are juxtaposed in the bends within the vascular structure. The sole connecting member between members 2126 and 2127 may be an arm 2129 that functions as a hinge element configured to self-align with the neutral axis and allow the device to articulate easily in the bends.

[0081] Similarly, member 2127 can be connected to a third expandable member, or any number of expandable members distal to it. In some examples, member 2126 may include interconnected struts without distal connecting elements, such as those terminating at crowns 2133, 2134, and other struts such as 2144 terminating at joints, such as crown 2145. The struts within the expandable member may be configured so that multiple crowns (e.g., crowns 2145, 2150) are not aligned at the same distance during loading. During loading or resheathing, generally, greater force may be required to load the crowns into the sheath than the struts. Therefore, if multiple crowns are loaded simultaneously, the user may notice an increase in loading force. Similarly, the second expandable member 2127 may include interconnected struts terminating at crown 2134 and without distal connecting elements, and other struts terminating at joints.

[0082] In some embodiments, the expandable member of member 2102 may include one or more markers 2125 having radiopaque material, such as, but not limited to, gold, tungsten, tantalum, platinum, or alloys containing these or other elements with high atomic numbers. Polymer materials (e.g., polyurethane, Pebax, nylon, polyethylene, etc.) containing radiopaque fillers, such as barium sulfate, bismuth subcarbonate, barium oxychloride, gold, tungsten, platinum, iridium, tantalum, alloys of these materials, and / or adhesives filled with radiopaque fillers, may also be used. In this regard, the markers 2125 may be included as small holes on struts throughout member 2102. The markers 2125 may be positioned to indicate the distal end of member 2102 to the user to aid in the accuracy of deployment.

[0083] Referring to Figure 5, another apparatus 3000 according to the present disclosure is shown. Similar to apparatuses 1000 and 2000, apparatus 3000 can be mounted on a shaft 1006 and may include a pinch member 3020 and a distal inner member 3103 extending distally from member 3020. Member 3020 may be formed with a relatively cylindrical pinch portion 3021. However, member 3020 is not limited in this way and may instead be non-planar, similar to member 2020, but not helical or curved, and member 3020 may instead be formed with a relatively straight pinch portion 3021. In some embodiments, member 3020 may have a decreasing diameter starting from, for example, a joint 3027, as it extends distally from the pinch portion 3021 to member 3103. The pinch portion 3021 may include a plurality of rhombic closure cells larger than the closure cells of member 3103. The device 3000 may include an expandable member 3140 that extends from shaft 1006 through shaft 3056 into and / or along member 3020, as will be described more specifically in Figures 6A and 6B.

[0084] As clearly shown in Figure 6A, member 3020 may include a proximal pinch portion 3021 that can transition from member 3020 to an inner member 3103 which includes a series of interconnected struts that taper to a narrower width in member 3103. Member 3103 may have a non-planar shape, such as flat or helical. For example, 3103 may include a flat or single-cell waveform. In another example, member 3103 may form a tubular inner channel, similar to member 2103. The distal end of member 3103 may include an expansion portion formed from an expanded strut 3010 having a larger diameter than the portion of member 3103 that proximal to it. The strut 3010 may be connected to a coil portion 3108, thereby allowing the strut 3010 to significantly restrict the path of blood clot fragments through it. In some examples, the coil portion 3108 may include a fortress shape that is joined to the distal collar of the outer member 3140 while assembled.

[0085] Referring to Figure 6B, an isometric view of member 3140 is shown. Member 3140 may include a proximal shaft 3056 that extends distally to a joint 3057, as shown. The joint 3057 may be a joint offset from the inner channel 3103 (e.g., at joint 3027) so that the outer struts of member 3140 do not interfere with the embedding of blood clots in the pinch portion 3021 and maintain pinching ability. Extending from there may be one or more proximal struts 3120 connected to an expandable member 3126 at their proximal and distal ends, which can be seen and described more clearly in U.S. Patent Application No. 16 / 946,467, which is incorporated herein by reference as if it were described in its entirety word for word. As shown, the struts 3120 may have a tapered contour to ensure a gradual change in stiffness from the shaft 3156 toward the blood clot engagement portion of member 3140. Although not shown in the diagram, member 3126 can be connected to a second expandable member up to the distal end of member 3140.

[0086] Member 3126 can be connected to the distal portion of member 3140 by a plurality of connecting arms 3129 that can extend from the proximal junction 3139 to the distal junction 3141. The arms 3129 may include generally straight struts that extend parallel to the central axis of member 3140. In other embodiments, the connecting arms 3129 may comprise a plurality of struts configured in one or more cells, or they may comprise curved arms or helical arms. The region between member 3126 and the distal end 3109 may include at least two inlets 3122 through which a blood clot can pass and enter a receptive space defined by the region between member 3140 and member 3103, as shown in member 3020 in Figure 6A. In some examples, member 3126 may include interconnected struts without a distal connecting element terminating at the crown 3133 and other struts such as struts 3122 terminating at the junction 3123. Similar to members 2126 and 2127, the segmented hinge design of the strut between member 3126 and its distal scaffolding portion is also specifically adjusted to be juxtaposed in the bend within the vascular structure, thereby allowing arm 3129 to self-align with the neutral axis and function as a hinge element configured to allow the device to easily articulate in the bend.

[0087] The blood clot inlet opening 3122 can provide the blood clot with a primary degree of freedom of movement, so that the expansion of member 3140 drives the blood clot toward the receiving space. Member 3140 can be configured to allow a portion of the blood clot to enter the receiving space, and thereby enable the blood clot to be retrieved without excessive compression. This is advantageous because the inventors have found that compressing a blood clot causes dehydration, which in turn increases the frictional properties and rigidity of the blood clot, making it difficult to detach and remove the blood clot from the blood vessel. This compression can be avoided because, as the blood clot moves inward through the wall of member 3140, the porous structure moves outward toward the blood vessel wall.

[0088] In some embodiments, member 3140 may include one or more markers 3125 having a radiopaque material, such as, but not limited to, gold, tungsten, tantalum, platinum, or alloys containing these or other elements with high atomic numbers. Polymer materials (e.g., polyurethane, Pebax, nylon, polyethylene, etc.) containing radiopaque fillers, such as barium sulfate, bismuth subcarbonate, barium oxychloride, gold, tungsten, platinum, iridium, tantalum, alloys of these materials, and / or adhesives filled with radiopaque fillers, may also be used. In this regard, the markers 3125 may be included as small holes on the struts throughout member 3140. The markers 3125 may be positioned to indicate the distal end of member 3140 to aid in deployment accuracy. The distal end of member 3140 may include a circumferential ring of struts connected to a series of struts 3124, which may terminate at a distal joint 3109 that may include a collar. The strut 3124 can form multiple closed cells for capturing blood clot fragments. In some embodiments, member 3140 can terminate at a closed distal end, and in other embodiments, the distal end of member 102 may be open or not necessarily closed. In some embodiments, the strut 3124 may have a generally conical shape as shown. In some embodiments, the strut 3124 may be configured to be generally planar, and this planar may be inclined or perpendicular to the longitudinal axis of the device 3000. The struts 3124 and 3149 can be tapered to a width narrower than the width of the more proximal struts, including the body of the expandable member 3126, thereby allowing for a gradual change in the stiffness of the device in both the expanded and folded states.

[0089] Referring to Figure 7A, another apparatus 4000 according to the present disclosure is shown. Similar to apparatuses 1000, 2000, and 3000, apparatus 4000 can be mounted on shaft 4006 and may include a pinch member 4020 structurally similar to pinch member 1020. Apparatus 4000 may include a fragment protection member 4050 having a wire 4056 similar to wire 1056, which connects the fragment protection member 4050 to a proximal joint 4058. The wire 4056 may be distally transferred to an inner member 4103 which may include a tubular inner flow path, similar to member 2103. The distal end of member 4103 may include an expansion formed from an expanded strut 4010 having a larger diameter than the proximal portion of member 4103. The strut 4010 may be connected to a coil portion 4108, thereby allowing the strut 4010 to significantly restrict the path of blood clot fragments through it. In some examples, the coil portion 4108 may include a fortress shape that is joined to the distal collar of the outer member 4140 while assembled.

[0090] Referring to Figure 7B, another apparatus 5000 according to the present disclosure is shown, similar to apparatus 4000. However, the fragment protection member 5050 does not have an inner tubular member (e.g., member 4103 of apparatus 4000). Instead, the wire 5056 of member 5050 can be directly transferred distally to the extended strut 4010.

[0091] Figures 8A to 10 illustrate the use of the apparatus of this disclosure. Figure 8A shows the guidewire 702 and microcatheter 703 being inserted into a vascular structure 700 and advanced across the occlusive blood clot 701 using conventionally known techniques. Once the microcatheter 703 is positioned distal to the occlusive blood clot 701, the guidewire 702 is withdrawn from the vascular structure 700 so that the declotting device 710 can advance through the microcatheter 703. The device 710 may be any of the declotting devices disclosed herein, and it is understood that the devices shown herein relate strictly to the device 1000 for illustrative purposes. The device 710 advances in a folded form until its distal tip reaches the distal end of the microcatheter 703. The microcatheter is retracted such that the distal end of the device is preferably positioned distal to the blood clot 701, while maintaining the orientation of the device 710 so that the declotting device can unfold across the blood clot 701 (Figure 8B). The device 710 may include a blood clot engagement portion 712 relating to the pinch portion of this disclosure, such as a pinch portion 1021 connected to an elongated proximal shaft portion 711.

[0092] The device 710 expands to engage with the occlusive blood clot at its proximal end or along its length. The device has segments that have a low-level scaffold and do not compress the clot, but allow the clot to protrude into these low radial force areas. As shown in Figure 9A, the device 710 may be incubated within the blood clot 701 for a period of time if necessary. As also shown in Figure 9A, the device 710 can apply outward radial force as indicated by the exemplary force arrows in both Figures 9A and 9B. Before retracting the device 710, as shown in Figure 9B, the microcatheter 7103 can be advanced distally to grasp a portion of the blood clot between the tip of the microcatheter and the strut and crown of the device adjacent to the low radial force area. This grasp allows for further grasping and control of the proximal end of the blood clot while it is moved and re-held into the access guide catheter 7004 or introducer sheath, as shown in Figure 10. The relative tension between the device 710 and the microcatheter 703 is maintained by the user during movement and retraction to ensure that gripping of the blood clot is reliably maintained. While using a microcatheter or intermediate catheter to grip the blood clot is described as providing additional advantages when used in the present invention, all embodiments described herein may also be used to move and retrieve the blood clot without using catheter gripping, if necessary.

[0093] Intravascular cessation of blood flow may be achieved by inflating a balloon (not shown) on the guide catheter 7004 using standard techniques. Figure 10 shows a blood clot engaged with the device during retrieval into the guide catheter 7004. Blood flow occlusion, aspiration, and other standard techniques may be used during the blood clot retrieval process. The device 710 may be rinsed and gently washed in saline before being reloaded into the insertion device. The device 710 may, if necessary, be reintroduced into the microcatheter 703 and redeployed into another segment of the occlusive blood clot.

[0094] As described throughout this document, a design scope is assumed for each of these elements, and any of these elements is intended to be used with any other element; however, to avoid repetition, these elements are not shown in all possible combinations.

[0095] It is desirable that all conventional blood clot removal devices and corresponding mechanisms be made from materials that can automatically restore their shape when released from a highly distorted delivery form. Superelastic materials such as nitinol or alloys with similar properties are particularly suitable. The material can be in many forms, such as wires, strips, sheets, or tubes. 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 connecting elements. This framework can be in any of the wide variety of shapes disclosed herein and may be visualized under fluorescence fluoroscopy through the addition of alloying elements (e.g., platinum) or through various other coatings or marker bands.

[0096] Figure 11 is a flowchart illustrating a method for removing a blood clot from a patient's blood vessel according to an aspect of the present disclosure. The steps of the method in Figure 11 can be carried out by any of the exemplary means described herein, or by similar means, as can be understood. Referring to method 8000 outlined in Figure 11, step 1010 involves unfolding the expandable structure of the device described herein until it is in contact with at least a portion of the blood clot. Step 8020 includes method 8000 grasping at least a portion of the blood clot with a proximal pinch portion. Step 8030 includes method 8000 capturing one or more fragments of the blood clot by a blood clot capture mechanism.

[0097] This disclosure is not limited to the embodiments described, which may vary in configuration and detail. The terms “distal” and “proximal” are used throughout the foregoing description and are intended to refer to location and direction relative to the treating physician. Thus, “distal” or “distal” refers to a location away from the physician or a direction away from the physician. Similarly, “proximal” or “proximal” refers to a location close to the physician or a direction toward the physician.

[0098] In the description of 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 similarly to achieve similar purposes. It should also be understood that reference to one or more steps of a method does not preclude the existence of additional method steps or method steps intervening between those explicitly identified steps. Each step of a method can be performed in an order different from that described herein without departing from the scope of the disclosed art. Similarly, reference to one or more components in a device or system should also be understood that does not preclude the existence of additional components or components intervening between those explicitly identified components.

[0099] In the context of this specification, “patient” or “subject” may be a human or any animal. It should be understood that the animal may be any applicable type, but is not limited to mammals, veterinary animals, domestic animals, or pet animals. For example, the animal may be a laboratory animal specifically selected to possess certain characteristics similar to those of a human (e.g., rats, dogs, pigs, monkeys, etc.).

[0100] As used herein, the terms “about” or “approximately” for any number or range of numbers indicate a suitable dimensional tolerance that enables a part or set of components to function in accordance with its intended purpose as described herein. More specifically, “about” or “approximately” may refer to a range of values ​​within ±20% of the listed values, for example, “about 90%” may refer to a range of values ​​between 71% and 99%.

[0101] "Comprising," "containing," or "including" means that at least the specified compound, element, particle, or process step is present in the composition, article, or method, but does not exclude the presence of other such compounds, substances, particles, or process steps, even if those other compounds, substances, particles, or process steps have the same function as the specified one.

[0102] It should also be noted that in this specification and the appended claims, the singular forms “a,” “an,” and “the” also include plural references unless otherwise clearly indicated by the context. A range may be expressed herein as a range from one specific value and / or another specific value of “about” or “approximately.” Other exemplary embodiments, when expressing such a range, also include a range from one specific value and / or another specific value.

[0103] The descriptions contained herein are embodiments of the Disclosure and are not intended to limit the scope of the Disclosure in any way. While specific embodiments of the Disclosure are described, various modifications to the devices and methods can be made without departing from the scope and spirit of the Disclosure. For example, while the embodiments described herein refer to specific components, the Disclosure includes other embodiments that utilize various combinations of components to achieve the described functionality, utilize alternative materials to achieve the described functionality, combine components from various embodiments, and combine components from various embodiments with known components. The Disclosure intends to replace the component parts illustrated herein with other well-known commercial products. These modifications will often be obvious to those skilled in the art and are intended to fall within the scope of the following claims.

[0104] [Implementation Method] (1) A blood clot removal device for removing blood clots from blood vessels, An expandable structure comprising a plurality of interconnected struts configured to engage with a blood clot, having a constrained delivery form and an extended blood clot engagement deployment form, wherein the interconnected struts are configured such that at least a portion of the plurality of interconnected struts mutually penetrates the blood clot in the extended blood clot engagement deployment form, and the expandable structure is The distal part and, An expandable structure including a proximal pinch portion located proximal to the distal portion, configured to hold a blood clot during movement from the expanded blood clot engagement deployment form to at least partially constrained blood clot holding form, A blood clot capture mechanism, The proximal end and The distal end and A shaft extending from the proximal end and distally from the proximal end of the proximal pinch portion, A blood clot removal device comprising a blood clot capture mechanism, which includes a capture member extending from the distal end of the shaft into the distal portion. (2) The apparatus according to Embodiment 1, wherein the shaft includes a curve and / or pitch equivalent to that of the pinch portion. (3) The apparatus according to Embodiment 1, wherein the expandable structure includes an open distal end. (4) The apparatus according to Embodiment 1, wherein the capturing member further comprises a proximal opening structure having a diameter substantially equal to the diameter of the distal portion of the expandable structure, the proximal opening structure comprises a fragment protection member having closure cells smaller than the closure cells of the distal portion and the proximal pinch portion, and the most distal end of the proximal opening structure is positioned at the distal end of the distal portion. (5) The apparatus according to Embodiment 1, wherein the proximal end of the capturing member is positioned at or near the location where the proximal pinch portion contacts the distal portion.

[0105] (6) The distal portion of the expandable structure further comprises a distal barrel portion that widens outward to form a barrel shape having an open distal end, and the interconnected struts comprise at least a plurality of proximal struts and a plurality of distal struts, The apparatus according to Embodiment 1, wherein at least some lengths of the proximal-facing struts are longer than at least some lengths of the distal-facing struts, thereby changing the outward radial force of the apparatus in the expanded blood clot engagement deployment configuration. (7) The apparatus according to Embodiment 1, wherein the shaft and the proximal pinch portion of the blood clot capture mechanism have a helical shape with a helical pitch in the range of approximately 10 to 25 mm. (8) The apparatus according to Embodiment 1, further comprising a longitudinal axis extending through the distal portion, wherein the shaft and the proximal pinch portion of the blood clot capture mechanism extend spirally around the longitudinal axis. (9) The apparatus according to Embodiment 1, further comprising a blood clot engaging element configured to exert an outward radial force when the proximal pinch portion is deployed into the blood vessel having an inner diameter smaller than the inner diameter of the expanded deployed form, wherein the blood clot engaging element is configured to exert an outward radial force that changes in a substantially sinusoidal pattern along the length of the blood clot engaging element. (10) The distal portion is An internally expandable body with a strut framework, The apparatus according to Embodiment 1, comprising an outer expandable body including a framework of struts that form an outer body radially surrounding the inner body while in the constrained delivery form and the extended unfolded form, wherein the outer expandable body is expandable in a radial range to define a blood clot containment space.

[0106] (11) The apparatus according to embodiment 10, wherein the framework of the struts of the outer expandable body comprises a plurality of discontinuous expandable members spaced apart from adjacent expandable members, and the struts of each expandable member form a closed cell having at least a number of struts terminating at radially separated distal apex not connected to an adjacent closed cell. (12) The apparatus according to Embodiment 1, wherein the proximal pinch portion has a diameter larger than the diameter of the distal portion, and the proximal strut of the expandable structure passes through one or more cells of the proximal pinch portion. (13) The apparatus according to Embodiment 1, wherein the proximal pinch portion has a diameter larger than the diameter of the distal portion, and the proximal strut of the expandable structure is located both inside and outside the proximal pinch portion. (14) The apparatus according to Embodiment 1, wherein the proximal pinch portion has a diameter larger than the diameter of the distal portion, and the distal portion comprises an internally expandable body including a porous internal body channel. (15) The capturing member The apparatus according to Embodiment 14, comprising an outer expandable body including a framework of struts that form an outer body radially surrounding the distal portion while in the constrained delivery form and the extended unfolded form, wherein the outer expandable body is expandable in a radial range such that it defines a blood clot containing space between the outer expandable body and the distal portion.

[0107] (16) The apparatus according to embodiment 15, wherein the outer expandable body comprises a closed distal end and at least one scaffolding segment proximal to the closed distal end, the at least one scaffolding segment comprising a plurality of closed cells, and the distal portion extending inward of the at least one scaffolding segment. (17) The apparatus according to embodiment 16, wherein the closed end formed by the distal scaffolding zone includes a plurality of struts that taper distally by a closed cell smaller than the proximal cell in the outer expandable body. (18) The apparatus according to embodiment 17, comprising an internally expandable body including a porous internal body channel whose distal portion is terminated by a plurality of distal struts, wherein each distal strut has a first end connected to the distal end of the porous internal body channel and a second end connected to one another to form a connection point. (19) The apparatus according to embodiment 18, wherein the plurality of distal struts are spirally shaped. (20) The apparatus according to embodiment 18, wherein the plurality of distal struts are configured in a bulging or spreading pattern.

Claims

1. A blood clot removal device for removing blood clots from blood vessels, An expandable structure comprising a plurality of interconnected struts configured to engage with a blood clot, having a constrained delivery form and an extended blood clot engagement deployment form, wherein at least a portion of the plurality of interconnected struts is configured to mutually penetrate the blood clot in the extended blood clot engagement deployment form, and the expandable structure is, The distal part and, An expandable structure including a proximal pinch portion located proximal to the distal portion, configured to hold a blood clot during movement from the expanded blood clot engagement deployment form to at least partially constrained blood clot holding form, A blood clot capture mechanism, The proximal end and The distal end and A shaft extending from the proximal end and distally from the proximal end of the proximal pinch portion, The blood clot capture mechanism includes a capture member extending from the distal end of the shaft into the distal portion, A blood clot removal device wherein the shaft includes a curve and / or pitch equivalent to that of the proximal pinch portion.

2. The blood clot removal device according to claim 1, wherein the expandable structure includes an open distal end.

3. A blood clot removal device for removing blood clots from blood vessels, An expandable structure comprising a plurality of interconnected struts configured to engage with a blood clot, having a constrained delivery form and an extended blood clot engagement deployment form, wherein at least a portion of the plurality of interconnected struts is configured to mutually penetrate the blood clot in the extended blood clot engagement deployment form, and the expandable structure is, The distal part and, An expandable structure including a proximal pinch portion located proximal to the distal portion, configured to hold a blood clot during movement from the expanded blood clot engagement deployment form to at least partially constrained blood clot holding form, A blood clot capture mechanism, The proximal end and The distal end and A shaft extending from the proximal end and distally from the proximal end of the proximal pinch portion, The blood clot capture mechanism includes a capture member extending from the distal end of the shaft into the distal portion, A blood clot removal device wherein the capturing member further comprises a proximal opening structure having a diameter substantially equal to the diameter of the distal portion of the expandable structure, the proximal opening structure comprises a fragment protection member having closure cells smaller than the closure cells of the distal portion and the proximal pinch portion, and the most distal end of the proximal opening structure is positioned at the distal end of the distal portion.

4. The blood clot removal device according to claim 1, wherein the proximal end of the capturing member is positioned at or near the location where the proximal pinch portion contacts the distal portion.

5. The expandable structure further comprises a distal barrel portion that widens outward to form a barrel shape having an open distal end, and the plurality of interconnected struts comprises at least a plurality of proximal-facing struts and a plurality of distal-facing struts, The blood clot removal device according to claim 1, wherein at least some of the lengths of the plurality of proximal-facing struts are longer than at least some of the lengths of the plurality of distal-facing struts, thereby changing the outward radial force of the blood clot removal device in the expanded blood clot engagement deployment configuration.

6. The blood clot removal device according to claim 1, wherein the shaft and the proximal pinch portion of the blood clot capture mechanism have a spiral shape with a spiral pitch in the range of approximately 10 to 25 mm.

7. The blood clot removal device according to claim 1, further comprising a longitudinal axis extending through the distal portion, wherein the shaft and proximal pinch portion of the blood clot capture mechanism extend spirally around the longitudinal axis.

8. The blood clot removal device according to claim 1, further comprising a blood clot engaging element configured to exert an outward radial force when the proximal pinch portion is deployed into the blood vessel having an inner diameter smaller than the inner diameter of the expanded deployed form, wherein the blood clot engaging element is configured to exert an outward radial force that changes in a substantially sinusoidal pattern along the length of the blood clot engaging element.

9. The distal portion is, An internally expandable body with a strut framework, A blood clot removal device according to claim 1, comprising: an outer expandable body including a framework of struts that form an outer body radially surrounding the inner expandable body while in the constrained delivery form and the extended unfolded form, wherein the outer expandable body is expandable in a radial range to define a blood clot containment space.

10. The blood clot removal device according to claim 9, wherein the framework of the struts of the outer expandable body comprises a plurality of discontinuous expandable members spaced apart from adjacent expandable members, and the struts of each expandable member form an occlusion cell having at least a number of struts terminating at radially separated distal apex portions not connected to adjacent occlusion cells.

11. A blood clot removal device for removing blood clots from blood vessels, An expandable structure comprising a plurality of interconnected struts configured to engage with a blood clot, having a constrained delivery form and an extended blood clot engagement deployment form, wherein at least a portion of the plurality of interconnected struts is configured to mutually penetrate the blood clot in the extended blood clot engagement deployment form, and the expandable structure is, The distal part and, An expandable structure including a proximal pinch portion located proximal to the distal portion, configured to hold a blood clot during movement from the expanded blood clot engagement deployment form to at least partially constrained blood clot holding form, A blood clot capture mechanism, The proximal end and The distal end and A shaft extending from the proximal end and distally from the proximal end of the proximal pinch portion, The blood clot capture mechanism includes a capture member extending from the distal end of the shaft into the distal portion, A blood clot removal device wherein the proximal pinch portion has a diameter larger than the diameter of the distal portion, and the proximal strut of the expandable structure passes through one or more cells of the proximal pinch portion.

12. A blood clot removal device for removing blood clots from blood vessels, An expandable structure comprising a plurality of interconnected struts configured to engage with a blood clot, having a constrained delivery form and an extended blood clot engagement deployment form, wherein at least a portion of the plurality of interconnected struts is configured to mutually penetrate the blood clot in the extended blood clot engagement deployment form, and the expandable structure is, The distal part and, An expandable structure including a proximal pinch portion located proximal to the distal portion, configured to hold a blood clot during movement from the expanded blood clot engagement deployment form to at least partially constrained blood clot holding form, A blood clot capture mechanism, The proximal end and The distal end and A shaft extending from the proximal end and distally from the proximal end of the proximal pinch portion, The blood clot capture mechanism includes a capture member extending from the distal end of the shaft into the distal portion, A blood clot removal device wherein the proximal pinch portion has a diameter larger than the diameter of the distal portion, and the proximal struts of the expandable structure are located both inside and outside the proximal pinch portion.

13. A blood clot removal device for removing blood clots from blood vessels, An expandable structure comprising a plurality of interconnected struts configured to engage with a blood clot, having a constrained delivery form and an extended blood clot engagement deployment form, wherein at least a portion of the plurality of interconnected struts is configured to mutually penetrate the blood clot in the extended blood clot engagement deployment form, and the expandable structure is, The distal part and, An expandable structure including a proximal pinch portion located proximal to the distal portion, configured to hold a blood clot during movement from the expanded blood clot engagement deployment form to at least partially constrained blood clot holding form, A blood clot capture mechanism, The proximal end and The distal end and A shaft extending from the proximal end and distally from the proximal end of the proximal pinch portion, The blood clot capture mechanism includes a capture member extending from the distal end of the shaft into the distal portion, A blood clot removal device wherein the proximal pinch portion has a diameter larger than the diameter of the distal portion, and the distal portion comprises an internally expandable body including a porous internal body channel.

14. The aforementioned capturing member, A blood clot removal device according to claim 13, comprising an outer expandable body including a framework of struts that form an outer body radially surrounding the distal portion while in the constrained delivery form and the extended unfolded form, wherein the outer expandable body is expandable in a radial range such that it defines a blood clot containing space between the outer expandable body and the distal portion.

15. The blood clot removal device according to claim 14, wherein the outer expandable body comprises a closed distal end and at least one scaffold segment proximal to the closed distal end, the at least one scaffold segment includes a plurality of closed cells, and the distal portion extends inward of the at least one scaffold segment.

16. The blood clot removal device according to claim 15, wherein the closed end formed by the distal scaffold zone includes a plurality of struts that taper distally by a closed cell smaller than the proximal cell in the outer expandable body.

17. The blood clot removal device according to claim 16, comprising an inner expandable body including a porous inner body channel whose distal portion is terminated by a plurality of distal struts, wherein each distal strut has a first end connected to the distal end of the porous inner body channel and a second end connected to one another to form a connection point.

18. The blood clot removal device according to claim 17, wherein the plurality of distal struts are spirally shaped.

19. The blood clot removal device according to claim 17, wherein the plurality of distal struts are configured in an inflated or spread-out pattern.

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