Mechanical thrombectomy apparatus

Abstract

A mechanical thrombectomy apparatus is provided. The mechanical thrombectomy device may comprise a support wire, a thrombectomy device, and a plurality of radiopaque markers. The thrombectomy device connects to the support wire and may comprise an expandable frame. The radiopaque markers can be attached to the expandable frame.

Description

mechanical thrombectomy device

[0001] The present invention relates to a thrombus removal device, and more particularly, but not exclusively, to a mechanical thrombus removal device used for removing thrombi in blood vessels.

[0002] Various methods exist to treat thrombosis in specific blood vessels within the body. Among these, mechanical thrombectomy devices are inserted into blood vessels to break up or remove the clot, restoring perfusion through the occluded vessel. Approved mechanical thrombectomy devices for this purpose include thrombus filters, thrombus aspiration devices, coil retrievers, and, more recently, stent retrievers.

[0003] Stent retriever devices are primarily used to remove acute thrombi in stroke patients. They involve deploying a self-expanding stent, typically made of wire mesh, into a blood vessel to capture the thrombus. The stent retriever then pulls on the supporting wire, allowing the clot to be retrieved from the patient. These devices require fluoroscopic visibility and the ability to capture, confine, or maintain the thrombus without damaging the narrow, tortuous vascular structure. Furthermore, they must not pose a risk during surgery.

[0004] For visibility during fluoroscopic diagnosis, conventional thrombectomy devices provided radiopaque markers on the distal tip and the wire or stent of the thrombectomy device. However, the existing markers tended to reduce the transmission characteristics of the thrombectomy device, and also had the problem of poor visibility of the markers during imaging for fluoroscopic diagnosis.

[0005] In addition, existing radiopaque markers had a problem of adversely affecting the flexibility of the strut of the thrombus removal device by forming a separate support structure on the strut of the thrombus removal device in order to mount the radiopaque marker on the thrombus removal device.

[0006] Conventional stent retriever devices do not provide optimal visibility. Most stent retriever devices today are not sufficiently radiopaque, making them difficult to visualize during fluoroscopy during surgery. Furthermore, conventional stent retriever devices have the disadvantage of compromising their transmission characteristics or flexibility in order to achieve radiopacity.

[0007] One object of the present invention to solve the above-mentioned problem is to provide a mechanical thrombus removal device having optimized visibility of a stent retriever device without deteriorating the transmission characteristics of the stent retriever device by having a plurality of radiopaque markers mounted on an expandable frame.

[0008] Another object of the present invention to solve the above-mentioned problems is to provide a stent retriever device that provides optimal visibility during fluoroscopy while maintaining flexibility of the device during surgery by directly providing a radiopaque marker having sufficiently long and flexible characteristics to an expandable frame.

[0009] However, the problem to be solved by the present invention is not limited to this, and may be expanded in various ways without departing from the spirit and scope of the present invention.

[0010] According to one embodiment of the present invention for achieving the above-described purpose, a thrombectomy device may include a mechanical thrombectomy device, comprising: a support wire; a clot arrestor connected to the support wire and including an expandable frame; and a plurality of radiopaque markers mounted on the expandable frame.

[0011] According to one aspect, the radiopaque marker may include a plurality of distal coil markers wound around a distal end of the expandable frame.

[0012] According to one aspect, the terminal coil marker may be formed of at least one material selected from the group consisting of platinum (Pt), iridium (Ir), stainless steel, gold, and tungsten.

[0013] According to one aspect, the strut forming the distal end portion in the expandable frame has a hook-shaped portion, and the distal end coil marker can be wound to be caught on the hook-shaped portion.

[0014] According to one aspect, the distal coil marker may be such that a coil side of the distal coil marker is at least partially soldered to a strut forming the distal end, both ends of the distal coil marker are attached to the strut by an adhesive, and the hook-shaped portion may be wrapped by the adhesive.

[0015] According to one aspect, the adhesive may be tapered into a dome shape at the hook-shaped portion and tapered into a fillet shape at the other end of the hook-shaped portion.

[0016] According to one aspect, the distal coil marker, the soldering area of ​​the distal portion, and the adhesive area of ​​the distal portion may have an outer diameter less than or equal to a first threshold value required for the transmission characteristics of the thrombus removal device.

[0017] According to one aspect, the radiopaque marker may include a plurality of strut coil markers wound around at least one strut forming each cell of the expandable frame.

[0018] According to one aspect, the strut coil markers can be regularly arranged on struts having the same orientation among the struts forming each of the cells provided in the expandable frame.

[0019] According to one aspect, the strut coil markers may be arranged in two cells, and the two strut coil markers may be arranged to be spaced apart from each other in the longitudinal direction of the expandable frame with respect to the transverse dividing axis of the cell.

[0020] According to one aspect, the strut coil markers may be arranged so as to be spaced apart from each other with a predetermined gap between each cell.

[0021] According to one aspect, the strut coil marker may be arranged obliquely with respect to the longitudinal axis of the thrombectomy device.

[0022] According to one aspect, the strut coil markers may be arranged to be spaced apart from each other in the longitudinal direction of the expandable frame.

[0023] According to one aspect, the plurality of strut coil markers can be arranged at different positions in the radial direction of the expandable frame.

[0024] According to one aspect, the strut coil marker may be such that a coil side of the strut coil marker is at least partially soldered to the strut, and both ends of the strut coil marker may be attached to the strut by an adhesive.

[0025] According to one aspect, the strut has flexibility, and the soldering can have a longitudinal length that maintains the flexibility of the strut even when attached to the strut coil marker.

[0026] According to one aspect, the adhesive can be tapered into a fillet shape.

[0027] According to one aspect, the strut coil marker and the soldering area of ​​the strut may have an outer diameter less than or equal to a second threshold value required for the transmission characteristics of the thrombus removal device.

[0028] According to one aspect, the strut coil marker can be formed of at least one material selected from the group consisting of platinum (Pt), iridium (Ir), stainless steel, gold, and tungsten.

[0029] The disclosed technology may have the following effects. However, this does not mean that a particular embodiment must include all or only the following effects, and thus the scope of the disclosed technology should not be construed as being limited thereby.

[0030] According to the mechanical thrombus removal device according to one embodiment of the present invention described above, by mounting a radiopaque marker on the strut of the expandable frame without providing a separate support structure or branch, etc., a mechanical thrombus removal device with optimized visibility of a stent retriever device can be provided without lowering the delivery characteristics of the device when delivering the mechanical thrombus removal device to the surgical site and when retrieving the mechanical thrombus removal device from the surgical site.

[0031] In addition, the mechanical thrombus removal device according to one embodiment of the present invention described above can provide a mechanical thrombus removal device with excellent usability by directly providing a radiopaque marker having sufficiently thin, long, and flexible characteristics to the strut of an expandable frame, thereby providing optimal visibility throughout the entire thrombus removal device during fluoroscopic diagnosis, and maintaining the flexibility of the device during surgery.

[0032] FIG. 1 is a plan view of a mechanical thrombus removal device according to one embodiment of the present invention.

[0033] FIG. 2 is a two-dimensional plan view of an expandable frame illustrating a distal coil marker according to one embodiment of the present invention.

[0034] FIG. 3 is an enlarged view of a distal coil marker according to one embodiment of the present invention.

[0035] FIG. 4 is an enlarged view of a distal end strut of a mechanical thrombus removal device according to one embodiment of the present invention.

[0036] FIG. 5 is a perspective view of a distal coil marker according to one embodiment of the present invention.

[0037] FIG. 6 is a two-dimensional plan view of an expandable frame illustrating a strut coil marker according to one embodiment of the present invention.

[0038] FIG. 7 is an enlarged view of a strut coil marker according to one embodiment of the present invention.

[0039] FIG. 8 is a drawing showing a photograph of a strut coil marker according to one embodiment of the present invention.

[0040] FIG. 9 is a perspective view of a strut coil marker according to one embodiment of the present invention.

[0041] FIG. 10 is a two-dimensional plan view of an expandable frame showing another arrangement of strut coil markers according to one embodiment of the present invention.

[0042] FIG. 11 is a partial two-dimensional plan view of an expandable frame showing another arrangement of strut coil markers according to one embodiment of the present invention.

[0043] FIG. 12 is a partial two-dimensional plan view of an expandable frame showing another arrangement of strut coil markers according to one embodiment of the present invention.

[0044] FIG. 13 is a schematic diagram illustrating another arrangement of strut coil markers according to one embodiment of the present invention.

[0045] FIG. 14 is a two-dimensional plan view of an expandable frame showing another arrangement of strut coil markers according to one embodiment of the present invention.

[0046] FIG. 15 is a schematic diagram showing the arrangement of a strut coil marker at the distal end of a thrombectomy device according to one embodiment of the present invention.

[0047] The present invention can be modified in various ways and has various embodiments, and specific embodiments are illustrated in the drawings and described in detail.

[0048] However, this is not intended to limit the present invention to specific embodiments, but should be understood to include all modifications, equivalents, or substitutes included in the scope of the invention and technology.

[0049] While terms such as "first," "second," etc. may be used to describe various components, these components should not be limited by these terms. These terms are used solely to distinguish one component from another. For example, without departing from the scope of the present invention, a first component could be referred to as a second component, and similarly, a second component could also be referred to as a first component. The term "and / or" includes any combination of multiple related items described herein or any item among multiple related items described herein.

[0050] When a component is referred to as being "connected" or "connected" to another component, it should be understood that it may be directly connected or connected to that other component, but that there may be other components intervening. Conversely, when a component is referred to as being "directly connected" or "connected" to another component, it should be understood that there are no other components intervening.

[0051] The terminology used in this application is only used to describe specific embodiments and is not intended to limit the present invention. The singular expression includes the plural expression unless the context clearly indicates otherwise. In this application, it should be understood that the terms "comprise" or "have" indicate the presence of a feature, number, step, operation, component, part, or combination thereof described in the specification, but do not exclude in advance the possibility of the presence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

[0052] Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Terms defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and will not be interpreted in an idealized or overly formal sense unless explicitly defined herein.

[0053] Hereinafter, preferred embodiments will be described in more detail with reference to the attached drawings. In order to facilitate an overall understanding in describing the present invention, identical reference numerals will be used for identical components in the drawings, and redundant descriptions of identical components will be omitted.

[0054]

[0055] As previously discussed, conventional stent retrievers have separate branches mounted on the struts for installing radiopaque markers. This necessitates increasing the number or length of branches to ensure sufficient visibility of the radiopaque markers. While this improves visibility, it also increases the radial profile of the stent retriever, significantly reducing the usability of the device during surgical delivery. Consequently, it has not been possible to realistically provide sufficiently visible radiopaque markers. Furthermore, conventional stent retrievers with separate support structures for radiopaque markers have the problem of reducing the flexibility of the stent retriever's expandable frame when installing the radiopaque marker, which has hindered the device's delivery performance during surgery.

[0056]

[0057] A mechanical thrombectomy device according to one embodiment of the present disclosure addresses the aforementioned issues by providing a plurality of radiopaque markers that are directly mounted on an expandable frame and are sufficiently visible and flexible. Furthermore, the device provides a mechanical thrombectomy device with excellent usability by effectively positioning the plurality of radiopaque markers so as not to affect the radial profile of the mechanical thrombectomy device.

[0058]

[0059] Below, a mechanical thrombus removal device according to one embodiment is described in more detail with reference to the drawings.

[0060]

[0061] Hereinafter, the term 'thrombus remover' in this description may refer to, for example, a part of a general stent retriever that includes a stent, but is not limited to a conventional stent retriever, and should be understood to include all components necessary to remove coagulated blood within a blood vessel and restore perfusion.

[0062] Additionally, the term 'expandable frame' in this description hereinafter shall be understood to mean a frame that is initially maintained in a compressed state and can be expanded after being moved to an appropriate location, and may be applied in any form known in the art.

[0063] Additionally, the use of relative terms throughout the description of the invention herein may indicate relative positions or directions. For example, “distal” may refer to a first direction along the longitudinal axis of the support wire or clot remover. Similarly, “proximal” may refer to a second direction opposite the first direction. For example, the longitudinal direction of the clot remover may refer to a direction along the longitudinal central axis of the clot remover, the transverse direction may refer to a direction transverse to the longitudinal central axis of the clot remover, and the longitudinal axis may refer to the longitudinal central axis of the clot remover. However, these terms are provided to establish relative references and are not intended to limit the use or orientation of the mechanical clot remover to any particular configuration described in the various embodiments below.

[0064]

[0065] FIG. 1 is a plan view of a mechanical thrombus removal device according to one embodiment of the present invention. As illustrated in FIG. 1, the mechanical thrombus removal device (1) according to one embodiment may include, for example, a support wire (10), a thrombus remover (20), and a radiopaque marker (30).

[0066] A mechanical thrombectomy device (1) is an endovascular tool that can be used, for example, to treat acute ischemic stroke. The mechanical thrombectomy device (1) includes a proximal control region that allows an operator to advance, withdraw, and rotate a distal working region of the device. More specifically, the mechanical thrombectomy device (1) includes a support wire (10) that an operator can push to advance the distal working region, pull to withdraw the distal working region, or rotate to rotate the distal working region. In one embodiment, the support wire (10) can be a flexible elongated wire formed of a resilient material, such as stainless steel or a superelastic nickel titanium alloy.

[0067] A mechanical thrombectomy device (1) may include a thrombectomy device (20) that can be advanced through a microcatheter and deployed from the microcatheter into a target tissue. When deployed within the target tissue, the thrombectomy device (20) may capture, entrap, bind, or mechanically integrate with the thrombus. The bound thrombus may be retrieved from the patient by traction on the thrombectomy device (20) and a support wire (10) to retrieve the thrombus from the vascular structure.

[0068] The clot remover (20) can be sized and shaped to provide respective degrees of clot binding, clot capture, flexibility, or any other performance characteristic. The clot remover (20) is connected distally to the support wire (10) and can include an expandable frame (100). The expandable frame (100) is a generally elongated cylindrical frame structure capable of capturing and confining a clot within the interior of the cylindrical shape, and has flexibility, shape memory, and contraction functions and can be made of a shape memory alloy material including a nickel titanium alloy. The size and shape of each cell of the expandable frame (100) can be determined according to the performance characteristics of the clot remover as described above. The thrombus remover (20) can be formed by laser-cutting a cylindrical tube into a three-dimensional expandable structure, or by mechanical processing, chemical processing, electromechanical processing, electrodischarge processing, and various other methods known in the art, and accordingly, the expandable frame (100) of the thrombus remover (20) can have a circular cross-sectional profile as illustrated in FIG. 15, which will be described later.

[0069] The expandable frame (100) may be equipped with a plurality of radiopaque markers (30). The radiopaque markers (30) may include distal coil markers (200) and strut coil markers (300), which will be described in more detail later with reference to FIGS. 2 and 6. The radiopaque markers (30) may enhance the visibility of the device and provide a cue for the operator to locate a clot relative to the clot remover. The radiopaque markers (30) may include radiopaque markers mounted in a variety of ways, including radiopaque bands, wire coils, plating, or welding, coating, etc., which are conventional in the art. Alternatively, the radiopaque material may be plated onto the expandable frame (100). Alternatively, the radiopaque markers (30) may be formed as bands that are crimped onto the expandable frame (100). In one aspect, the radiopaque marker (30) may be wound or wrapped around an expandable frame (100) including a coil formed of radiopaque wire. In one aspect, the radiopaque marker (30) may have an atraumatic surface that does not damage the vessel wall during use.

[0070]

[0071] FIG. 2 is a two-dimensional plan view of an expandable frame (100) illustrating a distal coil marker (200) according to one embodiment of the present invention, and FIG. 3 is an enlarged view of the distal coil marker illustrated in FIG. 2. Referring to FIG. 2, the expandable frame (100) will first be described. The expandable frame (100) may be formed by a plurality of struts (131) forming each cell (130). While each cell (130) is illustrated as having a generally sinusoidal pattern, the pattern of the cells (130) is not limited thereto, and may have any shape depending on the performance characteristics of the thrombectomy device.

[0072] Referring to FIGS. 2 and 3, a plurality of distal coil markers (200) may be mounted on the distal end (110) of the expandable frame (100). More specifically, the distal coil markers (200) may be wound on a strut forming the distal end (110) of the expandable frame (100). The cells (130) of the expandable frame (100) forming the distal end (110) have different shapes, and the ends of each cell on which the distal coil markers (200) are wound are offset from each other in the longitudinal direction of the expandable frame (100). Accordingly, a plurality of distal coil markers (200-1, 200-2, 200-3) may also be wound on the expandable frame (100) while being offset from each other in the longitudinal direction of the expandable frame (100).

[0073] These distal coil markers (200) can be formed of at least one radiopaque material selected from the group consisting of platinum (Pt), iridium (Ir), stainless steel, gold, and tungsten. Accordingly, the distal coil markers (200) can provide visibility of the distal end (110) of the thrombectomy device (1).

[0074]

[0075] To explain the structure of the distal coil marker (200) in more detail, reference is made to FIGS. 4 and 5. FIG. 4 is an enlarged view of a strut (120) of a distal end (110) of a mechanical thrombus removal device (1) according to one embodiment of the present invention, and FIG. 5 is a perspective view of the distal coil marker (200) according to one embodiment of the present invention.

[0076] Referring to FIGS. 3 to 5, a straight strut (120) may extend longitudinally from the most distal cell of the expandable frame (100) at the distal end (110) of the expandable frame. The strut (120) forming the distal end (110) of the expandable frame (100) may have a hook-shaped portion (121) at the distal end, and the hook-shaped portion (121) may extend transversely of the expandable frame (100) so that a distal coil marker (200) may be caught thereon, as illustrated in FIG. 5.

[0077] More specifically, referring to FIG. 5, the distal coil marker (200) may include a coil (210), a soldering (220) region, and an adhesive (230) region. The coil (210) side of the distal coil marker (200) may be wound around a strut (120) forming a distal end (110), and the coil (210) side may be fixed to the strut (120) at least partially by soldering (220). In addition, both ends of the distal coil marker (200) may be attached to the strut (120) by an adhesive (230). At this time, the adhesive (230) may be applied in a form that wraps the hook-shaped portion (121).

[0078] The adhesive (230) can be tapered after being attached to both ends of the coil (210), and the adhesive (230) formed to wrap the hook-shaped portion (121) is tapered into a dome shape so as to sufficiently wrap the hook-shaped portion (121) and form a smooth curve. In addition, the adhesive (230) applied to the other end of the hook-shaped portion (121) can be tapered into a fillet shape. Due to this tapering, the edges or steps of the strut (120) and the hook-shaped portion (121) to which the distal coil marker (200) is attached can be smoothly wrapped, and an atraumatic surface can be provided that reduces frictional force when the mechanical thrombus removal device (1) moves within the blood vessel and prevents damage to the blood vessel wall.

[0079] The coil (210), soldering (220) region, and adhesive (230) region of the aforementioned distal coil marker (200) must have an outer diameter less than a first threshold value required for the transmission characteristics of the mechanical thrombus removal device (1) of the present invention. The mechanical thrombus removal device (1) of the present invention can have transmission characteristics required for details such as flexibility, compressibility, transmission system, and accuracy when delivering the device along the curve of a blood vessel to capture and retrieve a clogged thrombus in the blood vessel and improve the flow of blood flow. These transmission characteristics can be determined according to the details required during surgery.

[0080] As described above, when a plurality of distal coil markers (200) are arranged offset from each other at the distal end (110) of the expandable frame (100), the coil (210), the soldering (220) region, and the adhesive (230) region of the coil markers (200) can have an outer diameter less than a first threshold value that matches the respective transmission characteristics required for the mechanical thrombus removal device (1) of the present invention in this arrangement relationship, so that the mechanical thrombus removal device (1) can be used safely and accurately during surgery.

[0081] The range of the outer diameters below this first threshold value of the coil (210) side of the coil marker (200), the soldering (220) area, and the adhesive (230) area may be, for example, 0.5 to 0.3 mm, preferably 0.33 ± 0.02 mm. In addition, the length of the soldering may have a specific soldering length required so as not to exceed the required amount of soldering. The range of this soldering length may be, for example, 0.5 to 0.4 mm, preferably 0.40 ± 0.05 mm. In addition, the length of the adhesive may have a length required to create a dome shape or fillet, and may have a range of less than 0.2 mm.

[0082]

[0083] FIG. 6 is a two-dimensional plan view of an expandable frame illustrating a strut coil marker according to an embodiment of the present invention, FIG. 7 is an enlarged view of a strut coil marker according to an embodiment of the present invention, FIG. 8 is a drawing showing a photograph of a strut coil marker according to an embodiment of the present invention, and FIG. 9 is a perspective view of a strut coil marker according to an embodiment of the present invention. Hereinafter, a strut coil marker (300) according to an aspect of the present invention will be described in more detail with reference to FIGS. 6 to 9.

[0084] As illustrated in FIGS. 6 to 9, a radiopaque strut coil marker (300) according to one embodiment is a plurality of coil markers individually wound around at least one strut (131) forming each cell (130) of an expandable frame (100), which can provide radiopacity without impeding the delivery profile of a mechanical thrombectomy device (1). The strut coil marker (300) can be formed of at least one radiopaque material selected from the group consisting of platinum (Pt), iridium (Ir), stainless steel, gold, and tungsten. Therefore, the strut coil marker (300) can provide visibility of the operating area of ​​the expandable frame (100) of the thrombectomy device (1).

[0085] In one embodiment of the present invention, such a strut coil marker (300) may include a coil (310), a soldering (320) region, and an adhesive (330) region, as detailed in FIG. 9. The coil (310) side of the strut coil marker (300) may be at least partially soldered (320) to and secured to a strut (131) forming each cell (130).

[0086] The strut (131) on which the strut coil marker (300) is mounted has flexibility, and the soldering (320) can be formed to have a length that maintains flexibility without affecting the flexibility of the strut (131) even when the strut coil marker (300) is attached to the strut (131) by the soldering (320).

[0087] Alternatively, the material of the soldering (320) may be selected as a flexible alloy material to maintain flexibility, or the soldering (320) may be formed into a short length so as not to affect the flexibility of the coil (310) and the strut (131).

[0088] Alternatively, the strut (131) may also be tapered or ground at the portion that mounts the strut coil marker (300), so that the diameter of the strut coil marker (300) can be kept small even when the strut coil marker (300) is mounted, thereby benefiting the packing ratio of the mechanical thrombectomy device (1) (smaller, unexpanded profile) and assisting in improved delivery of the device through the microcatheter.

[0089] Additionally, both ends of the strut coil marker (300) can be attached to the strut (131) by an adhesive (330). The adhesive (330) can be tapered into a fillet shape after being attached to the ends of the coil (310). Due to this tapering, the edge of the strut (131) to which the strut coil marker (300) is attached or the step portion of the strut coil marker (300) can be smoothly wrapped, and an atraumatic surface can be provided that reduces frictional force when the mechanical thrombus removal device (1) moves within the blood vessel and prevents damage to the blood vessel wall during use.

[0090] Meanwhile, the coil (310) side and soldering (320) area of ​​the strut coil marker (300) described above may have an outer diameter less than or equal to a second threshold value required for the transmission characteristics of the mechanical thrombus removal device (1) of the present invention. The mechanical thrombus removal device (1) of the present invention may have transmission characteristics required for each detail such as flexibility, compressibility, transmission system, and accuracy when delivering the device along the curve of a blood vessel to capture and retrieve a clogged blood clot in the blood vessel and improve the flow of blood flow, and these transmission characteristics may be determined by the details required during surgery.

[0091] As described above, when the plurality of strut coil markers (300) are directly wound and arranged on each strut (131) of the expandable frame (100), they have an outer diameter less than or equal to a second threshold value that matches the respective transmission characteristics required for the mechanical thrombus removal device (1) of the present invention, so that the mechanical thrombus removal device (1) can be used safely and accurately during surgery. The range of the outer diameter less than or equal to the second threshold value that may not affect the transmission profile of the coil (210) and soldering (320) of the strut coil marker (300) may be, for example, 0.2 to 0.15 mm, and preferably, 0.18 ± 0.01 mm.

[0092] In addition, the soldering (320) should not be excessive compared to the required amount of soldering and should have a soldering length formed in a length that does not affect the flexibility of the coil (310) and the strut (131). The length of this soldering can range from 0.5 to 0.15 mm, for example, and can be preferably 0.30 ± 0.10 mm. The length of the coil (310) should also range from 1.5 to 0.5 mm, for example, and can be preferably 1.0 ± 0.1 mm, so as not to negatively affect the transmission profile. The length of this coil can range from 1.5 to 0.5 mm, for example, and can be preferably 1.0 ± 0.1 mm. In addition, the length of the adhesive (330) forming the fillet at both ends of the coil (310) can range from less than 0.2 mm, similar to the end coil marker (200).

[0093] Alternatively, for example, the aspect ratio of the coil (310) length to the coil (310) diameter of the strut coil marker (300) can range from 5 to 6. Preferably, for example, the aspect ratio of the coil (310) length to the coil (310) diameter of the strut coil marker (300) can range from 5.2 to 5.8. Since the strut coil marker (300) having such an aspect ratio is relatively more than 5 times longer in length compared to diameter, the strut coil marker (300) can contain more radiopaque material, thereby providing better visibility in the operating area when the mechanical thrombectomy device (1) is used.

[0094] The ranges of the outer diameters of the coil (310) and soldering (320) of the strut coil marker (300) described above and the lengths of the coil (310), soldering (320), and adhesive (330) are within a range that does not affect the transmission characteristics when the mechanical thrombus removal device (1) is used, thereby enabling the provision of a mechanical thrombus removal device (1) with excellent usability. In addition, since the length of the coil (310) is relatively long compared to radiopaque markers of competitive products, the visibility of the marker can be greatly improved when used, and accordingly, the accuracy when the mechanical thrombus removal device (1) is also improved. In addition, by directly winding the strut coil marker (300) on the strut (131) and partially applying soldering (320) to the side of the coil (320) as shown in FIGS. 7 to 9, it is possible to provide a mechanical thrombus removal device (1) having excellent transmission characteristics during use while maintaining the flexibility of the coil (320) and the strut (131).

[0095]

[0096] Referring again to FIG. 6, the arrangement of strut coil markers (300) according to one embodiment of the present invention will be described. A plurality of strut coil markers (300) can be regularly arranged on struts (131) having the same orientation among the struts (131) forming each cell (130) in a two-dimensional plan view of the expandable frame (100) as illustrated in FIG. 6. In the embodiment of FIG. 6, each strut coil marker (300) can be arranged without overlapping each other in the longitudinal direction of the expandable frame (100) as illustrated by the arrow. In addition, each strut coil marker (300) can also be arranged without overlapping each other in the transverse direction of the expandable frame (100). This arrangement provides a smaller, non-expanded profile of the thrombectomy device, which may facilitate improved delivery of the thrombectomy device via a microcatheter, thereby providing a thrombectomy device with superior usability and accuracy. Accordingly, the rules for arranging the strut coil markers (300) can be applied in any possible combination within the range where the strut coil markers (300) do not overlap each other in the longitudinal and transverse directions of the expandable frame (100).

[0097]

[0098] FIG. 10 is a two-dimensional plan view of an expandable frame showing another arrangement of strut coil markers according to one embodiment of the present invention. In the embodiment of FIG. 10, each strut coil marker (300) is regularly arranged on a strut (131) of the same orientation among the struts (131) forming each cell (130) provided in the expandable frame (100), similarly to FIG. 6. However, the orientation of the struts (131) is different from that illustrated in FIG. 6. Since the same effect as that of the arrangement of the strut coil markers (300) illustrated in FIG. 6 can be applied to the arrangement of the strut coil markers (300) illustrated in FIG. 10, a description corresponding to FIG. 6 will be omitted.

[0099] In the embodiments illustrated in FIGS. 6 and 10, the strut coil markers (300) can all be arranged obliquely with respect to the longitudinal axis of the thrombectomy device in the longitudinal direction of the expandable frame (100) indicated by the arrows. This oblique arrangement allows the strut coil markers (300) to be fully visualized in the longitudinal direction of the device without increasing the radial profile of the device when compressed, compared to if the strut coil markers (300) were arranged longitudinally straight when the thrombectomy device (1) is compressed longitudinally.

[0100] Additionally, in the embodiments illustrated in FIGS. 6 and 10, the strut coil markers (300) can be arranged to be spaced apart from each other with a predetermined spacing between each cell (130). Referring to FIGS. 6 and 10, when viewed diagonally with respect to the longitudinal direction of the expandable frame (100), each strut coil marker (300) has cells (130) in which no strut coil marker (300) is arranged between cells (130). The number or arrangement of the cells (130) in which no strut coil marker (300) is arranged can be determined depending on the performance characteristics of the device. This arrangement can provide uniform visibility across the longitudinal length of the expandable frame (100) since the strut coil markers (300) are spaced apart from each other at a uniform spacing.

[0101]

[0102] FIG. 11 is a partial two-dimensional plan view of an expandable frame (100) illustrating another arrangement of strut coil markers (300) according to one embodiment of the present invention. In the embodiment illustrated in FIG. 11, the strut coil markers (300) may be arranged on struts (131) of the same orientation forming each cell (130) in a diagonal direction with respect to the longitudinal axis of the expandable frame (100). In this case, the strut coil markers (300) may be arranged sequentially in each cell (130) without there being a cell (130) between each cell (130) where no strut coil markers (300) are arranged. This arrangement may have the advantage that the radiopaque strut coil markers (300) may be visualized as being longer in the longitudinal direction of the expandable frame (100) compared to the arrangement of the strut coil markers (300) illustrated in FIGS. 6 and 10.

[0103]

[0104] FIG. 12 is a partial two-dimensional plan view of an expandable frame (100) illustrating another arrangement of strut coil markers (300) according to one embodiment of the present invention, FIG. 13 is a schematic diagram illustrating another arrangement of strut coil markers (300) according to one embodiment of the present invention, and FIG. 14 is a two-dimensional plan view of an expandable frame illustrating another arrangement of strut coil markers (300) according to one embodiment of the present invention.

[0105] In the embodiment of FIG. 12, two strut coil markers (300) can be placed in one cell (130) of the expandable frame (100). When two strut coil markers (300) are placed in one cell (130), the strut coil markers (300) can be placed opposite each other on the struts (131) of the same orientation, and can be placed spaced apart from each other with a predetermined interval between each cell (130) according to a certain rule.

[0106] In one aspect, as illustrated in FIG. 12, two strut coil markers (300) arranged in one cell (130) on the upper side of the expandable frame (100) and one strut coil marker (300) arranged on the lower side of the expandable frame (100) may have different lengths. This arrangement of strut coil markers (300) having different lengths may be utilized to highlight and display a specific portion of the thrombectomy device (1). That is, this arrangement may be utilized to more easily visualize a desired location by arranging strut coil markers (300) having relatively longer lengths at a specific location of the thrombectomy device (20) so as to more clearly identify the target action point of the thrombectomy device (20) as needed.

[0107]

[0108] More specifically, referring to FIG. 13, two or more strut coil markers (300) may be arranged in one cell (130), for example, two strut coil markers (300) may be arranged on opposing struts (131) spaced apart from each other in the longitudinal direction of the expandable frame (100) with respect to the transverse dividing axis (illustrated by a dotted line) of the cell (130).

[0109] In the embodiment illustrated in FIG. 13, two strut coil markers (300) arranged in one cell (130) may be arranged at non-overlapping positions in the longitudinal direction of the expandable frame (100). The two strut coil markers (300) may be arranged spaced apart from each other by the same distance in the longitudinal direction of the expandable frame (100) as indicated by arrows, with respect to the transverse dividing axis of the expandable frame (100). This spacing distance may vary depending on the length of the strut coil markers (300).

[0110]

[0111] FIG. 14 is a two-dimensional plan view of an expandable frame (100) showing another arrangement of strut coil markers (300) according to one embodiment of the present invention. In the embodiment of FIG. 14, the strut coil markers (300) can be regularly arranged on the struts (131) of the same orientation among the struts (131) forming each cell (130) about the transverse dividing axis of the expandable frame (100). The strut coil markers (300) illustrated in FIG. 14 can have an arrangement in which the strut coil markers (300) are spaced apart from each other in the longitudinal direction of the expandable frame (100) similarly to the embodiments of FIGS. 6 and 10, but have a difference in that the strut coil markers (300) are arranged in the cells (130) on the same line about the transverse direction of the expandable frame (100), indicated by the dotted line, at a transverse distance from each other.

[0112] When strut coil markers (300) are respectively arranged on the struts (131) of the same orientation in the cells (130) that are laterally on the same line, the strut coil markers (300) can be arranged to be spaced apart from each other in the longitudinal direction of the expandable frame (100) at a distance on both sides of the transverse dividing axes shown in dotted lines in FIG. 14. Accordingly, the strut coil markers (300) can be arranged closer in the longitudinal direction of the expandable frame (100) than when two strut coil markers (300) are respectively arranged on opposing struts (131) in one cell (130) as shown in FIG. 13. However, even in this arrangement, the strut coil markers (300) can be spaced apart from each other in the longitudinal direction of the expandable frame (100) without overlapping each other.

[0113] The strut coil markers (300) arranged as shown in FIG. 14 may appear longer when viewed longitudinally in the expandable frame (100) than two strut coil markers (300) arranged in cells (130) on the same line in the transverse direction, when combined as one strut coil marker (300), which may also have the effect of increasing the visibility of the radiopaque marker.

[0114]

[0115] FIG. 15 is a schematic diagram illustrating the arrangement of strut coil markers (300) at the distal end of a thrombectomy device (20), according to one embodiment of the present invention. Referring to FIG. 15, the radial arrangement of strut coil markers (300) according to one embodiment of the present invention will be described. Although a plurality of strut coil markers (300) are illustrated in two-dimensional plan views in FIGS. 6 to 14 for illustration purposes, in actual use, they may be distributed radially spaced apart from each other around the circumference of a generally cylindrical expandable frame (100). The strut coil markers (300) may be arranged at different positions in the radial direction of the expandable frame (100), for example, as illustrated in FIG. 15. Preferably, the strut coil markers (300) may be arranged at substantially equal intervals in the radial direction when viewed from the ends of each expandable frame (100) as illustrated in FIG. 15, but such intervals may not necessarily be equal, and may be arranged in an arrangement suitable for the transmission characteristics of the mechanical thrombectomy device (1) without increasing the radial profile of the mechanical thrombectomy device (1).

[0116] Since the strut coil markers (300) of the present invention are arranged to be spaced apart in the longitudinal and transverse directions of the expandable frame (100) as described above, the strut coil markers (300) may not overlap each other and the radial profile of the mechanical thrombus removal device (1) may not increase. In addition, the mechanical thrombus removal device (1) according to one embodiment of the present invention has the configuration and arrangement of the radiopaque markers (30) as described above, so that the visibility of the radiopaque markers (30) can be significantly improved compared to the stent retriever device of the prior art, and a smaller, non-expanded profile of the mechanical thrombus removal device (1) can be provided, thereby providing improved delivery performance of the mechanical thrombus removal device (1) via a microcatheter.

[0117] In addition, for example, as illustrated in FIG. 6, the strut coil marker (300) can be arranged diagonally with respect to the longitudinal axis of the thrombus remover (20) and spirally in the radial direction, thereby expanding the radial arrangement area. Accordingly, fluoroscopic diagnosis is possible regardless of the radial orientation of the thrombus remover (20) with respect to the fluoroscopic diagnosis device.

[0118]

[0119] Although the invention has been described with reference to the drawings and embodiments, it is not intended that the scope of protection be limited by the drawings or embodiments, and it will be understood that those skilled in the art can make various modifications and changes to the invention without departing from the spirit and scope of the claims set forth below.

[0120] The present invention described above is not limited to the above-described embodiments and the attached drawings, and it will be apparent to a person skilled in the art to which the present invention pertains that various substitutions, modifications, and changes can be made within a scope that does not depart from the technical spirit thereof.

[0121] The combination of the above-described embodiments is not limited to the above-described embodiments, and various combinations may be provided in addition to the above-described embodiments depending on implementation and / or needs.

[0122] The above-described embodiments include examples of various aspects. While not all possible combinations to illustrate the various aspects can be described, those skilled in the art will recognize that other combinations are possible. Accordingly, the present invention is intended to encompass all other alterations, modifications, and variations within the scope of the following claims.

[0123] [Explanation of symbols]

[0124] 1: Mechanical thrombectomy device

[0125] 10: Support wire

[0126] 20: Thrombolytic Device

[0127] 30: Radiopaque marker

[0128] 100: Expandable frame

[0129] 110: Distal end

[0130] 120: Strut (forming the distal end)

[0131] 121: Hook shape

[0132] 130: Cell

[0133] 131: Strut

[0134] 200: Terminal coil marker

[0135] 210: Coil side

[0136] 220: Soldering

[0137] 230: Adhesive

[0138] 300: Strut Coil Marker

[0139] 310: Coil side

[0140] 320: Soldering

[0141] 330: Adhesive

Claims

1. As a mechanical thrombectomy device, support wire; A clot arrestor connected to the support wire and including an expandable frame; and a plurality of radiopaque markers mounted on the expandable frame; Mechanical thrombectomy device.

2. In paragraph 1, The above radiopaque marker is, comprising a plurality of distal coil markers wound on the distal end of the expandable frame; Mechanical thrombectomy device.

3. In paragraph 2, The above terminal coil marker is, Formed of at least one material selected from the group consisting of platinum (Pt), iridium (Ir), stainless steel, gold, and tungsten. Mechanical thrombectomy device.

4. In paragraph 2, In the above expandable frame, the strut forming the distal end has a hook-shaped portion, The above terminal coil marker is wound to be caught on the hook-shaped part, Mechanical thrombectomy device.

5. In paragraph 4, The above terminal coil marker is, wherein the coil side of the distal coil marker is at least partially soldered to the strut forming the distal end, Both ends of the above terminal coil marker are attached to the strut by adhesive, The above hook-shaped portion is wrapped by the adhesive, Mechanical thrombectomy device.

6. In paragraph 5, The above adhesive, The hook-shaped portion is tapered into a dome shape, and the other end of the hook-shaped portion is tapered into a fillet shape. Mechanical thrombectomy device.

7. In paragraph 6, The above distal coil marker, the soldering area of the distal portion, and the adhesive area of the distal portion have an outer diameter less than or equal to a first threshold value required for the transmission characteristics of the thrombus removal device. Mechanical thrombectomy device.

8. In paragraph 1, The above radiopaque marker is, A plurality of strut coil markers wound around at least one strut forming each cell of the expandable frame, Mechanical thrombectomy device.

9. In paragraph 8, The above strut coil marker is, Among the struts forming each of the cells provided in the above expandable frame, struts having the same orientation are regularly arranged, Mechanical thrombectomy device.

10. In paragraph 9, The above strut coil marker is, Two are arranged in one cell, and the two strut coil markers are arranged to be spaced apart from each other in the longitudinal direction of the expandable frame with the transverse dividing axis of the cell as the center. mechanical thrombectomy device 11. In paragraph 9, The above strut coil marker is, Each of the above cells is arranged so as to be spaced apart from each other with a predetermined gap between them, Mechanical thrombectomy device.

12. In paragraph 9, The above strut coil marker is, Positioned diagonally with respect to the longitudinal axis of the above thrombus remover, Mechanical thrombectomy device.

13. In paragraph 12, The above strut coil marker is, are arranged so as to be spaced apart from each other in the longitudinal direction of the above expandable frame, Mechanical thrombectomy device.

14. In paragraph 12, The above plurality of strut coil markers are, are arranged at different positions in the radial direction of the above expandable frame, Mechanical thrombectomy device.

15. In paragraph 8, The above strut coil marker is, The coil side of the above strut coil marker is at least partially soldered to the strut, Both ends of the above strut coil marker are attached to the strut by an adhesive, Mechanical thrombectomy device.

16. In paragraph 15, The above strut has flexibility, The above soldering has a longitudinal length that maintains the flexibility of the strut even when attached to the strut coil marker. Mechanical thrombectomy device.

17. In paragraph 15, The above adhesive is tapered into a fillet shape, Mechanical thrombectomy device.

18. In paragraph 17, The above strut coil marker and the soldering area of the strut have an outer diameter less than or equal to a second threshold value required for the transmission characteristics of the thrombus removal device. Mechanical thrombectomy device.

19. In paragraph 8, The above strut coil marker is formed of at least one material selected from the group consisting of platinum (Pt), iridium (Ir), stainless steel, gold, and tungsten. Mechanical thrombectomy device.

Images