Occlusion device with self-expanding strut

Abstract

A self-expanding occlusion device includes a hypotube. The outer diameter of the occlusion device automatically expands or increases, and when deployed to a target location, the occlusion device automatically forms a final shape. The increased outer diameter and final shape of the occlusion device may be maintained when exposed to one or more conditions of the target location.

Description

[0001] Cross-references to related patent applications

[0002] Priority is hereby claimed to U.S. Application No. 17 / 686,359, filed on March 3, 2022 (“359 Application”), entitled “OCCLUSIVE DEVICE WITH SELF-EXPANDING STRUTS.” The entire disclosure of the 359 Application is hereby incorporated herein. Technical Field

[0003] The present disclosure generally relates to self-expanding devices that can occlude voids and passages (such as arteries, veins, other blood vessels, chambers, and other similar structures) within a subject's body. More specifically, the present disclosure relates to self-expanding occlusion devices formed from hypotubes. In addition, methods of occluding voids and passages within the human body, as well as methods of manufacturing, are also disclosed. Background Art

[0004] Occlusive devices, including coils and embolic bodies, are used therapeutically and diagnostically to slow or stop blood flow, as well as to occlude other voids within a subject's body. Figure 1A and 1B Images of the same blood vessel before and after placement of an occlusive device, showing the effect of the occlusive device on the subject's blood vessel. Occlusive devices can be used for a variety of purposes, including treatment of arteriovenous malformations, hemorrhages, perforations, aneurysms, tumors (e.g., devascularization), varicose veins, congestion, and other conditions.

[0005] Occlusive devices, such as coils, are typically self-expanding devices that are designed to be constrained in a loading device and then pushed to a target location via a tubular catheter, sheath, needle, cannula (various "delivery devices"), or other similar device, and then withdrawn from the tip of the delivery device and self-expanded to facilitate therapeutic occlusion. Metal-based coils are more common than polymer coils. Certain coils include polymers, fibers, coatings, fabrics, marker bands, and other features on the exterior of a metal or polymer stent, between stent features, and / or proximal or distal to stent features.

[0006] Figure 2A and 2B Excerpted from White, Ken, Cloft, and Kallmes, “Coil in a Nutshell: A Review of Coil Physical Properties,” AJNR, August 2008 (“White”), showing a specific design of an occlusive device comprised of a coil. Figure 2A and 2BThe coil shown in FIG. 1 includes a thin solid wire 1° (primary structure, or "primary wire") having a wire diameter of D1. The thin solid wire 1° is molded into a coiled wire 2° (secondary structure, or "secondary spring" and / or "primary winding") having a coiled wire diameter of D2. Figure 2B As shown, the coiled wire 2° is shaped into a larger three-dimensional structure 3° (tertiary structure), such as a coiled tube, having an expandable diameter D3.

[0007] The diameter D2 of the coiled wire, or more specifically, the coil outer diameter (OD) 2°, determines the delivery size of the catheter for the coil. For example, a coil designed for a 0.018-inch delivery catheter will have a coiled wire diameter D2 or OD of approximately 0.018 inches or 0.46 mm, and a coil designed for a 0.035-inch delivery system will typically have a coiled wire diameter D2 or OD of approximately 0.035 inches or 0.89 mm. Manufacturers will often list their products under broad headings such as "0.018 Coil," "0.035 Coil," and other sizes, and note the coil's wire diameter D2.

[0008] As an alternative to the coiled wire 2°, the coiled tube 3° can use solid wire or solid composite wire.

[0009] Coiled tubing 3° represents the final expanded and unconstrained outer diameter, i.e., the tertiary shape of the coil. For example, a "035 5 mm x 2 cm coil" coiled wire has a diameter D2 of 0.035 inches or 0.89 mm, an unconstrained expandable diameter D3 of 5 mm, and a length of 2 cm. In clinical use, there are differences among manufacturers on how to size coils for placement in the target anatomy. For example, the Ruby (Penumbra) and Azur CX (Terumo) coils should not be oversized relative to the anatomy - a 5 mm expandable diameter D3 coil should be placed in a 5 mm inner diameter (ID) vessel. However, Boston Scientific and Medtronic recommend that clinicians oversize Interlock and Concerto coils by 10-20%, so a coil with an expandable diameter D3 of 5.5 or 6 mm should be placed in a 5 mm ID vessel. Some coils recommend oversizing by 30-50%.

[0010] Occlusive devices (including coil-shaped occlusive devices) can be formed into a variety of different tertiary shapes when deployed, such as Figure 2A and 3A The coiled tube 3° shape shown or symmetrical spiral shape, and various other shapes, including Figure 3B The asymmetric spiral shown, Figure 3C and 3D The funnel shape shown, Figure 3EThe spherical shape shown and various other shapes. These shapes and others are known in the art as coils.

[0011] The tertiary shape of an occlusive device (e.g., coil) can enable it to perform a specific function, such as primary occlusion, shaping, filling, stuffing, or other occlusive functions. Stuffing and stuffing coils can be used inside or immediately after (e.g., behind, etc.) a coil that provides primary occlusion. Figure 4 As shown, packing and filling coils may also be used within a void, such as an aneurysm sac, etc. The shaped coils may frame a target, such as the neck of a void, such as the neck of an aneurysm, etc., to focus packing coils and / or filling coils within the void, or to focus embolic material within the void.

[0012] While existing occlusive devices are useful, the occlusive effect they provide depends on the degree to which the primary structure and any coatings or auxiliary materials thereon can be compacted and combined when formed into a tertiary shape. Occluding a blood vessel typically requires placement of five or more conventional occlusive devices at adjacent locations within the vessel. Summary of the invention

[0013] According to the present disclosure, an occluding device includes, consists essentially of, or consists of a self-expanding body. The body may expand in such a way as to enlarge its outer diameter (OD) (i.e., a first degree of expansion) and cause the hypotube to assume a predetermined third shape, or its desired occluding shape or final shape (i.e., a second degree of expansion). Such an occluding device may be referred to as an "embolic body". Only one or two embolic bodies may be required to occlude a blood vessel.

[0014] In certain embodiments, the body of the occluding device may include a hypotube with an expandable portion. The expandable portion may include a plurality of slits that define struts. The slits may be arranged in a manner that allows the hypotube to expand from an original outer diameter (or unexpanded outer diameter) to an expanded outer diameter. The expanded outer diameter of the occluding device may be two or even three times its original outer diameter. The hypotube may also be formed in a manner that ultimately allows it to expand to its predetermined final shape or desired occlusive shape.

[0015] The hypotube of the occluding device may be made of a substantially rigid material that may be constrained into a shape that facilitates insertion and / or removal from a subject, but expands after the restraining force is removed. The hypotube may be made of, but is not limited to, a metal (e.g., nitinol, stainless steel, etc.) or a polymer (e.g., polyetheretherketone (PEEK)). The hypotube may be made of a shape memory material. In some embodiments, including but not limited to embodiments in which the hypotube is made of a shape memory material, the occluding device may assume a desired shape or its final shape after exposure to the conditions of a predetermined target location (e.g., temperature, humidity, etc.) and removal of any restraining force.

[0016] In some embodiments, rows of slits may be defined along the length of the expandable portion of the hypotube of the occluding device. Each row of slits may be positioned along a generative line of the expandable portion (i.e., a line extending from one end of the expandable portion of the hypotube to the other end of the expandable portion and parallel to the axis of the expandable portion). Alternatively, each row of slits may be arranged in a spiral around the hypotube. Each row of slits may be offset from the slits of an adjacent row. Each slit may overlap approximately half of one slit (if the slit is located at or near one end of the hypotube) or two slits (if the slits are located in the middle) of an adjacent row; in other words, the slits of the expandable portion may be arranged in a so-called "bricklaying" arrangement or may be arranged like bricks in a so-called "staggered pattern". Such an arrangement of slits and the struts defined by adjacent rows of slits may allow the expandable portion of the hypotube to assume a desired final shape (e.g., a symmetrical spiral, an asymmetrical spiral, a funnel, a modified funnel, a sphere, or any other desired shape).

[0017] In some embodiments, the slits of the expandable portion of the hypotube of the occluding device are arranged in a manner that allows the struts to generate torque and / or twist or rotate when the expandable portion or a portion thereof is expanded. This arrangement may also allow the expanded portion of the expandable portion to return to its unexpanded state once an appropriate restraining force acts on the hypotube (for example, when an external force constrains the hypotube within a tube, the diameter of the tube will decrease, the rotating struts will rotate back to a flat, unrotated position, etc.). With this arrangement, when the expandable portion is in a restrained or unexpanded state, it may have a smooth outer surface, thereby facilitating its movement in the catheter. As the expandable portion expands and its struts rotate, the struts may engage with surrounding tissue (such as vascular tissue, etc.), thereby fixing the expandable portion in place relative to the surrounding tissue.

[0018] According to the present disclosure, the manufacture of the occluding device may include cutting slits at appropriate locations in the wall of the hypotube. The hypotube may be loaded onto a mandrel to form the hypotube into a desired shape. The ideal shape of the hypotube may be set, thereby setting the ideal shape of the occluding device (for example, when the hypotube is made of a material such as nitinol, it may be set by heating). Then, a restraining force may be applied to the hypotube or the occluding device to cause it to shrink or contract. The restraining force may shrink the hypotube to a shape and size that is convenient for storage and subsequent insertion into a subject. In some embodiments, the occluding device may be confined within a loading device.

[0019] When the occluding device is required for use, it can be introduced into the subject. For example, a catheter can be advanced to a desired location in the subject. The occluding device can be introduced through the proximal end of the catheter and advanced through the lumen of the catheter to the desired location. When the occluding device is withdrawn from the distal tip of the catheter at the desired location, it can automatically form an increased outer diameter and a desired final shape, thereby at least partially occluding the desired location in a desired manner. The conditions (such as temperature, etc.) at the target location can cause the occluding device to self-expand and automatically form a final shape, and / or can cause the occluding device to maintain its increased outer diameter and final shape when exposed to one or more conditions at the target location.

[0020] Other aspects, features and advantages of the disclosed subject matter will become apparent to those of ordinary skill in the art from a review of the following description, drawings and appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In the attached picture:

[0022] Figure 1A and Figure 1B Before placement of the occlusive device ( Figure 1A ) and after ( Figure 1B ) Image of the same blood vessel, showing the effect of the occlusion device on the subject’s vessel.

[0023] Figure 2A and 2B Features of a prior art occlusive device are described, the occlusive device comprising a coil;

[0024] Figure 3A An embodiment of a coil-type occlusive device composed of a symmetrical helix is ​​shown;

[0025] Figure 3B An embodiment of a coil-type occlusive device composed of an asymmetric helix is ​​shown;

[0026] Figure 3C An embodiment of a coil-type occlusion device including a funnel-shaped device is shown;

[0027] Figure 3D An embodiment of a coil-type occlusion device including a modified funnel shape is shown;

[0028] Figure 3E An embodiment of a coil-type occluding device is shown, the occluding device being approximately spherical or ball-shaped;

[0029] Figure 4 The occlusion device within the aneurysm sac void is demonstrated;

[0030] Figures 5A-5D Embodiments of occlusive devices are described whose body includes an expandable portion having an expandable and contractible outer diameter (OD);

[0031] Figure 6A-1 and 6A-2 are an end view and an isometric view of the final shape of a conventional occluding device, respectively;

[0032] Figure 6B-1 and 6B-2 An end view and an isometric view, respectively, of one embodiment of an occluder device of the present disclosure are provided, the body of which is in an unexpanded state but is presented in a final shape;

[0033] Figure 6C-1 and 6C-2 Provided separately Figure 6B-1 and 6B-2 end and isometric views of an embodiment of the occluding device shown with the body in an expanded state and in its final shape;

[0034] Figure 7B Provided Figure 6B-1 and 6B-2 A detailed end view of an embodiment of the occluding device shown, the main body of which is in Figure 6B-1 and 6B-2 Unexpanded state shown;

[0035] Figure 7C yes Figure 6C-1 and 6C-2 A detailed end view of an embodiment of the occluding device shown, the main body of which is in Figure 6C-1 and 6C-2 The expanded state shown;

[0036] Fig. 8A yes Figure 6C-1 , 6C-2 7C and isometric views of a variant of the occluding device embodiment, the main body of which is in Figure 6C-1 , 6C-2 and the expanded state shown in 7C, with at least one end being tapered;

[0037] Figures 8B-8E yes Figure 6C-1 , 6C-2 7C and isometric views of other variations of the occluding device embodiment, wherein the body of the occluding device is in Figure 6C-1 , 6C-2 and 7C , in an expanded state, wherein at least one end of each occluding device is oriented along a longitudinal axis of the expanded occluding device;

[0038] Figure 8F and Figure 8G Provided is a method for forming a device having a nearly spherical shape (such as Figures 9A-9E A two-dimensional representation of a cutting pattern of an occluding device of FIG.

[0039] Figures 8H-8J yes Figure 8F and 8G Variations of the cutting pattern shown;

[0040] Figures 9A-9C are respectively a side view, a cross-sectional view and an oblique view of another embodiment of an occluding device according to the present disclosure, wherein the shape of the occluding device is approximately spherical;

[0041] Fig.9D and 9E Shows Figures 9A-9C A variation of the occlusive device embodiment shown, wherein at least some of the cells formed as the occlusive device body expands are larger than those formed as the occlusive device body expands. Figures 9A-9C The unit formed by the expansion of the main body of the occluding device shown is smaller;

[0042] Fig.9F and Figure 9G Provided is a method for forming a device having a nearly spherical shape (such as Figures 9A-9E A two-dimensional representation of a cutting pattern of an occluding device of FIG.

[0043] Fig.10 Shows Figures 9A-9C Another variation of the illustrated occlusive device embodiment wherein struts of the expandable portion of the body of the occlusive device have serrated edges;

[0044] Fig.11 Another final shape of an occluder device according to the present disclosure is described;

[0045] Fig.12 Embodiments of occlusive devices with expandable coatings and / or filler materials are presented;

[0046] Fig.13 Embodiments of occlusive devices including a fabric or film cover are presented;

[0047] Fig.14 Embodiments of methods for deploying an occlusive device at a target location within a subject are described;

[0048] Figures 15A-15D Examples of delivery systems and their use are shown; and

[0049] Figures 15E-15G Shows Figures 15A-15D Variations of the control lines of the depicted delivery system embodiments. DETAILED DESCRIPTION

[0050] Figures 5A-5D One embodiment of an occlusive device 10 is depicted. The occlusive device 10 is shown in an unexpanded or constrained state, which facilitates its introduction into and / or removal from a subject. Figure 5A As shown, the occlusive device 10 can assume an elongated state in the constrained state.

[0051] The occlusive device 10 includes a body 12. The body 12 can be made of various suitable materials or a combination of suitable materials. In some embodiments, the entire body 12 can be defined by or include a hypotube, which can be formed of a substantially rigid material such as a metal. Suitable metals include, but are not limited to, memory alloys (such as Nitinol, etc.), cobalt-chromium (CoCr), nickel-chromium (NiCr or nickel-chromium alloy (Nichrome)) alloys (including but not limited to nickel-chromium steel), stainless steel (such as 316L stainless steel, 316 stainless steel, etc.), etc. Alternatively, the body 12 can be made of a polymer. Suitable polymers can have sufficient hardness (for example, at least 35 Shore hardness, 35 to 55 Shore hardness, 35 to 72 Shore hardness, etc.). Suitable polymers include, but are not limited to, polyetheretherketone (PEEK), polyimide, nylon, polyether block amide (PEBA, such as the brand ) and extruded plastics (provided their wall thickness does not exceed the width of their struts 36, as described below).

[0052] like Figure 5A As shown, the expandable portion 30 of the body 12 of the occluding device 10 can expand outwardly (e.g., radially outwardly, etc.) from an unexpanded state to an expanded state and a final shape. For example, in an embodiment where the body 12 is formed of a shape memory material (e.g., a shape memory alloy), the expandable portion 30 can expand to its final shape when exposed to appropriate conditions (e.g., body temperature, etc.). As another example, in an embodiment where the body 12 is formed of stainless steel or a polymer, the expandable portion 30 can expand to its final shape after the restraining force acting on the body 12 is removed.

[0053] like Figures 5B-5D As shown, the expandable portion 30 can be defined by a series of slits 34a, 34b, 34c, etc. of slits 32 that extend at least partially through the wall of the body 12. In some embodiments, each slit 32 can extend completely through the wall of the body 12 from its outer surface to its inner surface. In other embodiments, each slit 32 can only partially extend through the wall of the body 12 (e.g., extending from the outer surface of the wall to the inner surface of the wall, etc.). The extent to which each slit 32 extends through the wall of the body 12 depends at least in part on the material of the body 12.

[0054] The slits 32 (except for some slits 32 at both ends of the expandable portion 30) can have the same length as each other. Adjacent slits 32 (slit series 32a, 32b, 32c, etc.) are separated by solid uncut areas of the body 12. These solid areas can be called seams 38 or interfaces.

[0055] Each series of slits 34a, 34b, 34c, etc. can be determined by a linear arrangement of slits 32. The slits 32 and each series of slits 34a, 34b, 34c, etc. can extend longitudinally along the body 12, and each series of slits 34a, 34b, 34c, etc. can be positioned along the generating line of the expandable portion 30 (i.e., a line extending from one end of the expandable portion 30 to the other end of the expandable portion 30, parallel to the longitudinal axis of the expandable portion 30). This direction can be referred to as a "straight" direction. Alternatively, each series of slits 34a, 34b, 34c, etc. can be arranged in a spiral around the body 12.

[0056] The slits 32 of each series of slits 34b, 34c, 34d, etc. may be offset relative to the slits 32 of each adjacent series of slits 34a, 34b, 34c, 34d, 34e, etc. Each slit 32 of each series of slits 34a, 34b, 34c, etc. may overlap approximately half of one (if the slits 32 are located at or near one end of the expandable portion 30) or two (if the slits 32 are located midway along the length of the expandable portion 30) circumferentially adjacent slits 32 of each adjacent series of slits 34a, 34b, 34c, etc. The staggered arrangement of the slits 32 about the circumference of the expandable portion 30 of the body 12 may give the expandable portion 30 a so-called "brickwork" appearance, with the solid portions of the body 12 between the slits 32 arranged in a so-called "staggered pattern."

[0057] The series of circumferentially adjacent slits 32 34a, 34b, 34c, etc. may be equally spaced about the circumference of the body 12. The expandable portion 30 may include a series of slits 34a, 34b, 34c, etc. having an even number of slits 32. In embodiments where an even number of series of circumferentially adjacent slits 32 34a, 34b, 34c, etc. are equally spaced about the circumference of the body 12, each slit 32 of the expandable portion 30 may be staggered relative to its circumferentially adjacent slits 32. Alternatively, the distance between slits 32 of a series of circumferentially adjacent slits 34a may be different from the distance between slits 32 of another series of circumferentially adjacent slits 34c; thus, the number of slits 32 of one series of circumferentially adjacent slits 34a may be different from the number of slits 32 of another series of circumferentially adjacent slits 34c.

[0058] The solid portion of the body 12 located between each pair of adjacent series 34a and 34b, 34b and 34c, 34c and 34d, etc. of the slots 32 comprises the struts 36 of the expandable portion 30. More specifically, each strut 36 may comprise a solid portion of the body 12 located between adjacent series 34a and 34b, 34b and 34c, 34c and 34d, etc. of the slots 32. In other words, each slot 32 comprises a gap between pairs of circumferentially adjacent struts 36. In embodiments where the series 34a, 34b, 34c, etc. of slots are oriented along the longitudinal axis of the body 12, the struts may also be oriented along the longitudinal axis of the body; in embodiments where the series 34a, 34b, 34c, etc. of slots are oriented helically around the body 12, the struts 36 may also be oriented helically around the body 12, or in a spiral shape.

[0059] The staggered arrangement of the slits 32 allows the expandable portion 30 to expand. In some embodiments, the struts 36 can rotate when the expandable portion 30 expands. For example, such rotation may occur in embodiments where each strut 36 that is circumferentially aligned around the expandable portion 30 includes an even number of struts 36. As the slits rotate, they protrude outward (e.g., radially, etc.) from the circumference of the expandable portion 30, thereby securing the occluder device 10 in place.

[0060] In other embodiments, the slits 32 are not staggered, and the struts 36 do not rotate when the expandable portion 30 expands. In this case, the resulting occlusive device 10 can still expand to form multiple contact points with the vessel wall or gap in which the occlusive device 10 is located to fix the occlusive device 10 in the vessel or gap.

[0061] The expandability provided by the slits 32 and struts 36 of the expandable portion 30 of the body 12 of the occluding device 10 enables the outer diameter (OD) of the body 12 to expand, thereby providing a first degree of expansion. In addition, as the outer diameter of the body 12 expands, the body 12 can assume a predetermined tertiary shape, or a desired occlusive shape or final shape, thereby providing a second degree of expansion.

[0062] 6A-6C illustrate a conventional occluder device 110 at a single expansion level while maintaining a final shape ( Figure 6A-1 and 6A-2 ) and the occlusion device 10 according to the present disclosure when expanded and maintained in its final shape at two or more levels of expansion ( Figures 6B-1 to 6C-2 ) were compared. Figure 6A-1 An end view of one embodiment of a conventional occlusive device 10' (eg, a 035 5 mm x 2 cm coil) is provided, the embodiment comprising a coiled wire 112, such as Figure 6A-2As shown, the coiled wire 112 has been coiled into the final shape of a conventional occluding device 110, that is, a coil shape. This conventional coiled occluding device 110 can reduce the area of ​​the lumen (such as a blood vessel, etc.) in which it is located (such as by about 59%). It is worth noting that the outer diameter of the coiled wire 112 will not expand.

[0063] Figure 6B-1 and 7B An end view of an embodiment of the occlusive device 10 of the present disclosure is provided, with the body 12 in an unexpanded state but exhibiting a coiled final shape, such as Figure 6B-2 The body 12 of the occlusive device 10 may have body dimensions (eg, outer diameter, etc.) that are the same or substantially the same as the corresponding dimensions of the coiled wire 112 of the conventional occlusive device 110 (eg, outer diameter 0.035 inches or 0.89 mm).

[0064] Although the outer diameter of the coiled wire 112 of the conventional occluding device 110 does not expand, Figure 6C-1 , 6C-2 As shown in FIGS. 7C and 7C , the outer diameter of the body 12 of the occlusive device 10 of the present disclosure can be expanded (e.g., expanded to twice the outer diameter, such as 0.070 inches or 1.8 mm). Figure 7C As shown, as the slits 32 open along the circumference of the body 12, the body 12 expands. Figure 6C-2 As shown, as the body 12 expands, the volume occupied by the body 12 increases, thereby enabling the occlusion device 10 to provide a better occlusion effect when forming its final shape (for example, the occlusion device 10 can reduce the area of ​​the tubular cavity in which it is located by at least about 75%, at least about 80%, at least about 85%, at least about 90%, or about 92%).

[0065] like Fig. 8A As shown, when the body 12 of the occluding device 10 is in an expanded state, the outer diameter of one or both ends 16, 17 of the body 12 can be the same as the outer diameter of the rest (central portion) of the body 12, and / or the outer diameter of one or both ends 16, 17 can be contracted (e.g., can be tapered at its end, a position adjacent to the end, etc.). In the described embodiment, the outer diameter of the end 16 is the same as the outer diameter of most of the body 12 (e.g., an outer diameter of 0.070 inches or 1.8 mm, etc.), while the outer diameter of the end 17 gradually tapers (e.g., an outer diameter of 0.035 inches or 0.89 mm, etc.).

[0066] Although FIGS. 6A-8A show a coil-type occlusive device 10 having ends 16 and 17 oriented in the direction of the coil, the ends 16 and 17 of the occlusive device 10 may be oriented in any of a variety of suitable directions. As an example, Figure 8BA variation of the occlusive device 10 is shown in which one or both of the ends 16 and 17 of the body 12 are arranged along the longitudinal axis A of the coiled, expanded body 12. L Such orientation of one of the ends 16 , 17 (eg, the leading or distal end 16 , etc.) may facilitate smooth deployment of the occluding device 10 .

[0067] Although Fig. 8A and 8B The outer diameter of the ends 16 and 17 of the occluder device 10 variant shown in FIG. 1 is substantially the same as the outer diameter of the remainder of the unexpanded body 12, but Figure 8C and 8D The occluder device 10 variant shown in FIG. 1 has ends 16 and 17 with a smaller outer diameter than the outer diameter of the unexpanded body 12. Ends 16, 17 that taper in this manner may be referred to as "tucked ends."

[0068] like Fig. 8E As shown, one or both of the ends 16, 17 of the occluding device 10 may be expanded outwardly in addition to tapering to an outer diameter that is smaller than the outer diameter of its unexpanded body 12 or being gathered. The expanded ends 16, 17 may expand to an outer diameter that is the same as the outer diameter of the expanded body 12, or the expanded outer diameter of the expanded ends 16, 17 may be smaller or larger than the outer diameter of the expanded body of the occluding device 10. The expanded ends 16, 17 may be used to block blood flow, promote clotting, secure the occluding device 10 (e.g., if the occluding device 10 is moved in the direction toward which the expanded ends 16, 17 are directed, the expanded ends 16, 17 may expand into the intima, etc.), promote endothelial tissue growth, or for any of a variety of other uses.

[0069] Fig.8D and 8E Display, with Figures 8A-8C Compared to the body 12 of the longer occluding device 10 shown in ( Figures 8A-8C The body 12 of the longer occlusive device 10 shown in FIG. 1 has four turns, but may have more than four turns), and the body 12 of the coil-type occlusive device 10 may be relatively short (e.g., it may have fewer than four turns, but at least one complete turn).

[0070] Figure 8F and Figure 8G A two-dimensional schematic diagram of a cutting pattern is provided for forming a curved shape (such as Figure 8B Occluding device 10 as shown). Figure 8F and Figure 8G The entire circumference of the hypotube 11 is depicted as it is split, expanded, and flattened. Figure 8F and Figure 8GThe cutting pattern shown in can be used to define struts 36 having a width of about 0.001 inches (about 0.025 millimeters) to about 0.009 inches (about 0.23 millimeters), and slits 32 having a width of about 0.001 inches (about 0.025 millimeters) to about 0.009 inches (about 0.23 millimeters) and a length of about 0.005 inches (about 0.13 millimeters) to about 0.035 inches (about 0.89 millimeters) between adjacent struts 36. In some embodiments, the slits 32 can be as long as about 0.125 inches (about 3.2 millimeters). In embodiments where the resulting occlusive device 10 has a length of about 1.633 inches (about 41.5 millimeters) and an outer diameter of about 0.035 inches (about 0.89 millimeters), or a length of about 1.905 inches (about 48.4 millimeters) and an outer diameter of about 0.038 inches (about 1 millimeter), it can include as few as about 50 slits 32 and as many as about 500 slits 32 or more.

[0071] Although Figure 8F and Figure 8G The slots 32 shown in the figure are linear or straight, but the slots 32 and the pillars 36 can have a variety of different shapes. As a non-limiting example, Figure 8H A cutting pattern with linear slits 321 and bow-tie shaped slits 32b is shown, Fig.8I A cutting pattern with linear gaps 321 and elliptical gaps 32o is shown, Figure 8J A cutting pattern with linear slits 321 and diamond-shaped slits 32d is shown. The shape of the slits 32 can impart different properties to the occluding device 10; for example, the shape of the slits 32 and struts 36 can affect the flexibility of the struts 36 (e.g., bow tie-shaped slits 32b can make struts 36b more flexible, etc.), the smoothness of the occluding device 10, the expandability of the occluding device 10, etc.

[0072] The metal mass of the occluder device 10 having a symmetrical spiral final shape and dimensions of approximately 5 mm x 2 cm can be reduced by 50% compared to a conventional occluder device having an outer diameter of approximately 0.035 inches (approximately 0.89 mm) and the same final shape and size. For example, a standard 035 5 mm x 2 cm coil with 0.005 inch (0.13 mm) wire has a metal volume of 2.387 cubic mm / cm, while a 035 5 mm x 2 cm coil occluder device 10 formed with a hypotube having a wall thickness of 0.0018 inches (0.046 mm) according to the present disclosure has a metal volume of 1.015 cubic mm / cm. Thus, the occluder device 10' of the present disclosure can reduce metal volume and mass by approximately 50% to approximately 80% compared to conventional occluders of the same size.

[0073] Reducing the metal mass can reduce computer axial tomography (CT) artifacts after the occlusion device 10 is implanted in the human body. Due to the size or location of the CT artifacts produced by conventional occlusion devices, some subject patients using existing conventional occlusion devices cannot effectively use CT imaging in future follow-up. Therefore, follow-up may require invasive angiography. By reducing CT artifacts, subjects using the metal occlusion device 10 of the present disclosure can receive CT scans in future follow-up.

[0074] When expanded to its final shape, the occlusive device 10 may assume the coiled shape described in FIGS. 6A-8E or a variety of different predetermined shapes. These final shapes include, but are not limited to, Figures 3A-3E Shape shown. Fig.11 Embodiments of diamond-shaped or double-funnel-shaped occluding devices are described.

[0075] Figures 9A-9C A view of an embodiment of an occlusive device 10' is provided, which includes an embolic body that assumes a near-spherical (e.g., spherical, elliptical, etc.) final shape in a fully expanded state (i.e., the body 12' of the occlusive device 10' is expanded and assumes its final shape). As shown, when the body 12' is in the expanded state, the struts 36' can be rotated outward (e.g., rotated up to about 90°, etc.), which can allow the occlusive device 10' to engage the tissue (e.g., the endothelium of a blood vessel, etc.) in which it is positioned and expanded. Without limitation, the diameter of the final shape can be up to about 5 mm. Fig.10 One variation of an occlusive device 10" is shown in which the slots 32" define struts 36" having serrated edges.

[0076] According to one specific embodiment of the present disclosure, the occlusive device 10' may have an unexpanded outer diameter of about 0.035 inches (about 0.89 mm), with 6 to 8 struts 36' on its circumference, the struts 36' having a width of about 0.009 inches (about 0.23 mm), and each pair of adjacent struts 36' being separated by a gap 32' having a width of about 0.010 inches (about 0.25 mm) and a length of about 0.035 inches (about 0.89 mm). When the body 12' of such an occlusive device 10' is expanded, the struts 36' may rotate and the gaps 32' may open to form cells 33' between adjacent struts 36'. Such an occlusive device 10' may expand from, for example, an outer diameter of about 0.035 inches (about 0.89 mm) to an outer diameter of about 0.105 inches (about 2.7 mm) or greater.

[0077] Variations of this occluding device 10' include Fig.9DAs shown, this variation includes narrower struts 36' and narrower slits 32'. When the body 12' of the occlusive device 10' is expanded, the size of the struts 36' and the slits 32' may limit the spacing between adjacent struts 36', thereby limiting the size of the cells 33' formed during the expansion process. The struts 36' may have a width of about 0.001 inches (about 0.025 mm) to about 0.009 inches (about 0.23 mm), the slits 32' may have a width of about 0.001 inches (about 0.025 mm) to about 0.009 inches (about 0.23 mm), and the length may be about 0.005 inches (about 0.13 mm) to about 0.030 inches (about 0.76 mm).

[0078] Fig.9E Another variation of the occlusive device 10′ is shown, which includes struts 36s′ and gaps 32s′, struts 36l′ and gaps 32l′, wherein the struts 36s′ and gaps 32s′ define smaller cells 33s′ on one side 12s′ of the body 12′, and struts 36l′ and gaps 32l′ define larger cells 33l′ on the other side 12l′ of the body 12′.

[0079] like Figures 9A-9C As shown in FIGS. 9E and 9E , one or both ends 16 ′, 17 ′ of the body 12 ′ of the expandable occlusive device 10 ′ may be slightly protruding or flared. Fig.9D As shown, one or both ends 16', 17' of the expanded occlusive device 10' may be flush or substantially flush with the remainder of the body 12' of the expanded occlusive device 10'. Fig.9D and 9E As shown, one or both ends 16', 17' of the expandable occlusive device 10' may extend into the body 12' of the expandable occlusive device 10', or one or both ends 16' and 17' may be recessed into the body 12'.

[0080] Fig.9F and 9G A method for forming a hypotube 11' having a substantially spherical shape (such as Figures 9A-9E A two-dimensional representation of one embodiment of a cutting pattern for an occluding device 10' (see those described herein). Fig.9F and 9G The entire circumference of the hypotube 11' is depicted as it is split, expanded, and flattened. Fig.9F and 9G The slots 32' shown in FIG. 3 are linear or straight, but the slots 32' and the struts 36' may have any of a variety of different shapes, see FIG. Figures 8H-8J , these shapes can impart different properties (eg, flexibility, smoothness, expandability, etc.) to the occlusive device 10' and / or its features.

[0081] As some non-limiting examples, a spherical occlusive device 10' can occlude a blood vessel having an inner diameter of about 3 mm to about 5 mm, has a length of about 6 mm to about 8 mm, and has an expanded outer diameter of about 6 mm. Such an occlusive device 10' can have an unexpanded outer diameter of about 0.020 inches (about 0.5 mm), and can include as few as 8 struts 36' and as many as 20 struts 36' (e.g., 10 struts 36', etc.) on its circumference. A spherical occlusive device 10' can occlude a blood vessel having an inner diameter of about 5 mm to about 7 mm, has a length of about 8 mm to about 10 mm, and has an expanded outer diameter of about 8 mm. Such an occlusive device 10' can have an unexpanded outer diameter of about 0.035 inches (about 0.89 mm), and can include as few as 10 struts 36' and as many as 40 struts 36' (e.g., 20 struts 36', 30 struts 36', 40 struts 36', etc.) on its circumference. The approximately spherical occluding device 10' can occlude a blood vessel having an inner diameter of about 7 mm to about 10 mm, has a length of about 12 mm to about 14 mm, and has an outer diameter of about 12 mm after expansion. The unexpanded outer diameter of the occluding device 10' can be about 0.035 inches (about 0.89 mm) and include as few as 20 struts 36' and as many as 80 struts 36' around its circumference.

[0082] In some embodiments, the occluding device 10, 10′, 10″, 10″′, 10″″, etc. (hereinafter referred to as the occluding device 10 for simplicity) according to the present disclosure may include a coating (e.g., an expandable coating, an elastic expandable / compressible coating, etc.) and / or a filler (e.g., an expandable coating, an elastic expandable / compressible filling material, etc.). The coating and / or the filler may provide a further occlusive effect. The coating may extend to the outer surface of the main body 12, 12′, 12″, 12″′, 12″″, etc. (hereinafter referred to as the main body 12 for simplicity) of the occluding device 10. The filler may be confined to the lumen of the hypotube that defines the main body 12 of the occluding device 10. The filler may absorb blood, thereby enhancing the ability of the occluding device 10 to prevent or occlude the flow of blood and blood-borne substances through the occluded blood vessel. In some embodiments, the coating and / or the filler may be bonded to the main body 12.

[0083] For example, the coating and / or filler may include a swellable hydrogel that expands once the occlusive device 10 is placed, thereby increasing the fill volume and packing density. Fig.12As shown, the occluding device 10'' can be equipped with an expandable polymer foam or mesh 40, which can be formed from a shape memory polymer (SMP), such as a polyurethane SMP (e.g., N,N,N',N'-tetrakis(2-hydroxypropyl)ethylenediamine (HPED); 2,2',2"-triethanolamine (TEA); 1,6-hexane diisocyanate (HDI); trimethylhexanediyl diisocyanate (2,2,4- and 2,4,4-mixed isomers) (TMHDI), etc.). In another example, the occluding device 10 can be equipped with flexible filaments or fibers that can be located within the cavity of the body 12 and extend through the slits 32 ( Figures 5B-5D ), and / or provided on the outer surface of the main body 12. Fig.13 In another example, a fabric (e.g., polytetrafluoroethylene, etc.) or a film 50 (e.g., a polymer film, etc.) may cover at least a portion (e.g., an outer surface and / or an inner surface, etc.) of the body 12"" of the occlusive device 10"" to prevent fluid from flowing through the open gap 32"" in the body 12"" ( Figures 5B-5D ). Other embodiments of fillers include, but are not limited to, other polymers, calcium alginate, starch, and other solid or semi-solid materials.

[0084] During the manufacturing process of the occlusive device 10, a filler may be introduced therein. In the case where the occlusive device 10 includes tapered or converging ends 16' and 17' (e.g. Figure 8C , 8D and 8E) and / or smaller units 33' (see, for example, Fig.9D ), the ends 16', 17' and / or the cells 33' enable the occluding device 10' to receive and at least temporarily retain a fill.

[0085] In addition to enhancing the occlusive ability of the occlusive device 10, the coating and / or filler may also serve as an alternative to imparting additional properties to the occlusive device 10. For example, the coating and / or filler may absorb fluids in the subject's body, thereby promoting embolization.

[0086] As another example, a filler can render the occlusive device 10 radiopaque. The filler can be bonded to the body 12 in a manner that allows the filler to expand with and / or within the body 12 and prevents the filler from moving out of the body 12 when in an expanded state. The filler can be cotton, nylon, fiber, filament, and / or other suitable material. The filler can be absorbent. In some embodiments, the filler can be made of a radiopaque material (e.g., tungsten, barium, iodine, bismuth trioxide (bismuth (III) oxide and / or Bi2O3), etc.) and / or other material that facilitates X-ray visualization.

[0087] Fillers can carry (e.g., absorb, etc.) substances to be delivered to a target site in a subject's body. Fillers can carry substances including, but not limited to, contrast agents, drugs, therapeutic agents (e.g., radioactive substances used for radiation therapy, etc.), etc. These substances can be applied to the filler during the manufacturing process, or applied by the clinician before, during, or after deployment during surgery.

[0088] Before the occluding device 10 is loaded into a catheter and delivered into a subject, the clinician may inject a substance into the transport and storage tube containing the occluding device 10. Any filler in the occluding device 10 may absorb or otherwise carry the substance. Alternatively, the substance may be applied to and absorbed by the filler during the manufacturing process of the occluding device 10.

[0089] In embodiments where the substance includes a contrast agent, the contrast agent will appear radiopaque under fluoroscopic X-rays to guide placement as the occluding device 10 is pushed through a catheter to the target location and the occluding device 10 expands at the target location. After deployment, the contrast agent may dissipate, elute, and / or flush out of the occluding device 10. This allows the occluding device 10 to be visible during placement, but after placement, the X-ray visibility will be reduced, which is beneficial for observing adjacent anatomical structures and pathological conditions. In embodiments where the substance includes a drug, a therapeutic agent (e.g., an anticancer drug or a radioisotope such as yttrium-90 (Y90) used in a radioembolization procedure), a nutrient, a diagnostic agent, a marker, a targeting compound, or the like, the substance will be eluted once the occluding device 10 is placed at the target location in the subject. The rate at which the substance is eluted from the filler over time, and therefore the rate at which the occluding device 10 is eluted, depends at least in part on any of a variety of factors that should be apparent to those of ordinary skill in the relevant art, including but not limited to the composition, density, and / or volume of the filler. The elution process may last for minutes, hours, days or even longer.

[0090] Alternatively, the clinician may deploy the occluding device 10 (with or without a filler) prior to or during advancement of the occluding device along the catheter and inject a substance into the catheter to deliver the occluding device 10. This allows the clinician to inject a substance into the catheter while advancing the constrained occluding device 10 through the catheter, but once the occluding device 10 is placed at the target location, the substance will diffuse.

[0091] Another method is to introduce the substance into the occluding device 10 or its filling material through a catheter after the occluding device 10 is deployed.

[0092] The substance may also be applied directly to the body 12 of the occluding device 10 (e.g., painted on one or more struts 36, etc.). Such a substance may be bonded, painted on, attached to, or otherwise applied to the body 12 of the occluding device 10. Alternatively, a band (e.g., a radiopaque band, etc.) carrying the substance may be crimped onto one or more struts 36 and / or one or both ends 16, 17 of the body 12.

[0093] In certain embodiments, the occluding device 10 may include a sensor. The sensor may include a passive sensor or an active sensor. The sensor may be located within or affixed to the body 12 of the occluding device 10. In certain embodiments, the sensor may include a radio frequency identification sensor or chip.

[0094] The method of manufacturing the occluding device 10 may use a hypotube (e.g., a Nitinol hypotube having an outer diameter of 0.035 inches (0.89 mm) and an inner diameter of about 0.030 inches (about 0.76 mm). Figures 5B-5D ) can be cut into a hypotube by any suitable process (such as laser cutting, mechanical processing (such as computer numerical control (CNC) processing, etc.), electrical discharge machining (EDM), chemical etching, etc.). The slit 32 can be cut from end to end of the hypotube so that the outer diameter of the hypotube expands uniformly along the entire length of the hypotube. Alternatively, the slit 32 may not extend to a location on the hypotube (e.g., one or both ends, one or more intermediate locations, etc.) that will not expand or remain constrained when the occluding device 10 expands. The constrained location can be used for a variety of purposes, such as retaining material within the interior of the occluding device 10, providing a connection point for a deployment mechanism that facilitates deployment and / or positioning of the occluding device 10, or connecting the occluding device 10 to another occluding device.

[0095] Cutting the slits 32 of the hypotube may result in the struts 36 having blunt edges or the struts 36 having sharp edges. In addition, the cutting of the slits may include feature definitions along the edges of the struts 36, such as teeth, serrations, edge roughness, etc. These features may secure the occluding device 10 at a target location within the subject, thereby promoting an endothelial and / or thrombotic response and / or preventing displacement of the occluding device 10 after it is positioned at the target location.

[0096] The edges of the pillars 36 are defined by the slits 32, which edges can be modified after the slits 32 are cut. In some embodiments, the edges can be ground. In other embodiments, the edges can be sharpened.

[0097] Other features may also be cut into the hypotube. For example, grooves, holes, slots or other features may be cut into one or both ends 16, 17 of the hypotube and / or one or more struts 36. These features may be engaged with a deployment mechanism (such as a detachable pusher, etc.). In a specific embodiment, the end 16 of the hypotube may form one or more circular internal thread indentations or channels (e.g., with a diameter of 0.003 inches or 0.076 mm, etc.); these internal thread indentations or channels may receive extendable / retractable circular external thread features (e.g., with a diameter of 0.003 inches (0.076 mm) or less) of the deployment mechanism. The connection may be strong enough for the user to deliver the device 200 (such as a catheter, sheath, cannula, needle, etc.) Fig.14 ) Push or pull the blocking device 10.

[0098] The cut hypotube can then be loaded onto a mandrel (e.g., a hardened steel mandrel) of a desired shape (e.g., a tapered straight tube, a spiral tube, a funnel tube, etc.). When the cut hypotube is loaded onto the mandrel, the hypotube may expand, increasing its inner and outer diameters (e.g., to about 0.075 inches or about 1.9 mm). The expansion of the cut hypotube may cause the slits 32 of the hypotube to open, exposing the struts 36 of the hypotube ( Figures 5B-5D ). The expanded, cut hypotube may then be heated to a sufficient temperature (e.g., about 400°C to about 600°C, etc.) for a sufficient time (e.g., up to 1 hour, etc.) to keep the nitinol in an expanded state. The hypotube is then cooled; the hypotube may remain on the mandrel or be removed from the mandrel. The cooled hypotube may then be constrained back to its original outer diameter by physically squeezing the outer diameter and / or pushing the cooled hypotube into a funnel-shaped hypotube fixture having an inner diameter ranging from about 0.080 inches (about 2.0 mm) to about 0.035 inches (about 0.89 mm) or less. The constrained hypotube may then be loaded (e.g., pushed into, etc.) into a transport and storage tube to keep the hypotube constrained until deployment. This manufacturing method is applicable to all sizes of hypotubes, including but not limited to 0.014 inch (0.36 mm) OD, 0.018 inch (0.46 mm) OD, 0.025 inch (0.64 mm) OD, 0.027 inch (0.69 mm) OD, and hypotubes of other OD, ID, and lengths.

[0099] Reference now Fig.14, a method of using the occluding device 10 includes advancing the distal tip 202 of a delivery device 200 (e.g., a catheter, sheath, hypotube, cannula, needle, etc. as described in the figure) to a target location T in a subject. The occluding device 10 can be transferred from a loading device (not shown) to the proximal end 204 of the delivery device 200. The occluding device 10 can be advanced along the length of the delivery device 200 until the distal tip 202 is reached. When the occluding device 10 is exposed or deployed from the distal end 202, the occluding device 10 can at least partially expand and can abut against a surface of the target location T (e.g., against the endothelium of a blood vessel, etc.). The deployment process can be achieved by pushing the constrained occluding device 10 distally (e.g., using a deployment mechanism 210, etc.) out of the distal tip 202, and / or by maintaining the position of the occluding device 10 in the subject (e.g., at the target location T) while pulling the delivery device 200 proximally.

[0100] Once the occluder device 10 is fully deployed from the distal tip 202, it may assume its final shape.

[0101] Once the occluding device 10 leaves the delivery device 200, the deployment mechanism 210 can remain connected to the occluding device 10. This allows the clinician to confirm the accuracy of the position. The clinician can push, pull, drag or otherwise move the at least partially expanded occluding device 10 to position the occluding device 10 at the target location T (e.g., using the deployment mechanism 210, etc.). The above movement may also denature, agitate or mechanically stimulate the intima at the target location T, thereby causing an inflammatory response (regardless of whether a sclerosing agent is injected), which may promote temporary or permanent fixation of the occluding device 10 at the target location T, thereby promoting temporary or permanent embolism.

[0102] If the accuracy of placement is acceptable, the deployment mechanism 210 may be separated from the occluding device 10 (eg, by retracting an expandable / retractable circular external thread feature of the deployment mechanism 210 to separate the deployment mechanism 210 from the occluding device 10 ).

[0103] Fig.15A 15H to 15H describe methods for delivering the occluding device 10 to a target location T ( Fig.14 ) is an embodiment of a conveying system 2. Fig.15AAs shown, the delivery system 2 includes a delivery device 200 (e.g., a catheter, sheath, hypotube, cannula, needle, etc.), a control wire 210, and an optional slider 220, which is used to control the movement of the control wire 210 through the distal and / or proximal end of the lumen of the delivery device 200. In some embodiments, the delivery device 200 may include a hypotube formed of any suitable material (e.g., stainless steel, nitrocellulose, polyester, PEEK, etc.), having an outer diameter of about 0.015 inches (about 0.38 mm) to about 0.035 inches (about 0.89 mm) or more, and an inner diameter large enough to accommodate the occlusion device 10 and the control wire 210. The control wire 210 may include a wire formed of any suitable material (e.g., stainless steel, nitinol, polyester, PEEK, etc.), and having an outer diameter of about 0.006 inches (about 0.15 mm) to about 0.020 inches (about 0.51 mm). The slider 220 (if present) may include a handheld slider that can be grasped by a clinician and includes a switch 222 that can be moved with the thumb or finger of the hand grasping the slider 220 to control the movement of the control wire 210 through the delivery device 200.

[0104] The control wire 210 may include a distal end 212 for carrying the occluding device 10 until the occluding device 10 is delivered to the target location T. Fig.15A As shown, when the occluding device 10 is located in the lumen of the delivery device 200 and the distal end 212 of the control wire 210 is located inside the occluding device, the delivery device 200 constrains the occluding device 10, and the occluding device 10 constrains the distal end 212 of the control wire 210. Therefore, the distal end 212 of the control wire 210 abuts against the inner surface of the occluding device 10, thereby engaging with the occluding device 10. When the distal end 212 of the control wire 210 is constrained inside the occluding device 10, it can remain relatively straight or curved. The occluding device 10 is also constrained in the lumen of the delivery device 200. As shown in FIG. Fig. 15B As shown, when the distal end 212 of the control wire 210 and the occluding device 10 carried by the distal end 212 are advanced beyond the distal end 202 of the delivery device 200, the distal end 212 of the control wire 210 may expand (eg, to twice its original outer diameter, etc.).

[0105] like Fig. 15B As shown, once the occluding device 10 and the distal end 212 of the control line 210 are advanced beyond the distal tip 202 of the delivery device 10, the distal end 212 of the control line 210 will expand along with the occluding device 10 it carries and expand within the occluding device 10, so that the control line 210 can continue to engage with the occluding device 10, thereby being used to reposition the occluding device 10 after the occluding device 10 exits the delivery device 200.

[0106] The configuration of the distal end 212 of the control wire 210 allows it to be more easily re-constrained than the occluding device 10. Thus, once the occluding device 10 is properly positioned at its target location T ( Fig.14 ),like Fig. 15C and Fig.15D As shown, the distal end 212 of the control wire 210 and the occluding device 10 can be pulled proximally against the distal tip 202 of the delivery device 200, and the distal end 212 of the control wire 210 can be withdrawn from the occluding device 10 and into the distal tip 202 of the delivery device 200. The delivery device 200 and the control wire 210 can then be withdrawn from the subject.

[0107] Although Figures 15A-15D The distal end 212 of the control wire 210 is shown having a curled shape when unconstrained and therefore expanded, but distal ends 212 having different expanded sizes and distal ends 212 having different shapes are also within the scope of the present disclosure. Figures 15E-15G Several different configurations of the expanded distal end 212 are described.

[0108] Without limitation, the occlusive device 10 according to the present disclosure may be used to promote lumen filling, reduce flow, improve thrombosis, improve hyperplasia, reduce X-ray density, or otherwise promote occlusion. Such an occlusive device 10 may be used in a variety of situations, including but not limited to arteriovenous malformations, hemorrhages, perforations, aneurysms, fibroids, varicose veins, congestion, distal embolism, and other situations. The occlusive device 10 may be used to treat COVID-19 patients who may exhibit elevated D-dimer levels (fibrin antigen fragments found in blood tests indicating a coagulopathy) and life-threatening blood clots in the heart, lungs, brain, and peripheral vessels. Bleeding is a complication of blood clots, and embolic devices may be used to treat bleeding. For example, refer to:

[0109] https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC7203058 /

[0110] https: / / www.medicalnewstoday.com / articles / covid-19-ive-never-seen-such-sticky-blood-says-thrombosis-expert

[0111] https: / / www.sciencedaily.com / releases / 2020 / 06 / 200630125129.htm

[0112] https: / / pubmed.ncbi.nlm.nih.gov / 32339221 /

[0113] https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC7146714 /

[0114] https: / / pubmed.ncbi.nlm.nih.gov / 32316063 /

[0115] https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC7225095 /

[0116] https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC7229939 /

[0117] https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC7255402 /

[0118] https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC7177070 / ,

[0119] The above-mentioned disclosure is hereby incorporated into this document.

[0120] Although the above disclosure provides many specific details, these details should not be understood as limiting the scope of any of the following claims, but merely providing some examples of the elements and features of the disclosed subject matter. Other embodiments of the disclosed subject matter and its elements and features can also be designed without departing from the spirit or scope of any claim. Features of different embodiments can be used in combination. Therefore, the scope of each claim is limited only by its express provisions and its legal equivalents.

Claims

1. An occluding device, comprising: A hypotube having struts which, when deployed to a target location within a subject, rotate and move apart from one another as the hypotube expands to an increased outer diameter and a final shape capable of at least partially blocking a passage through a portion of the subject's body.

2. The occlusive device of claim 1, wherein the ends of the hypotube are oriented along the longitudinal axis of the final shape of the hypotube.

3. An occlusive device according to claim 1 or 2, wherein, in the final shape of the sea wave tube, the end of the sea wave tube tapers from the enlarged outer diameter of the sea wave tube to a terminal outer diameter that is smaller than the enlarged outer diameter.

4. The occluding device according to claim 1 or 2, wherein: In the final shape of the hypotube, a portion of the hypotube adjacent the end tapers from an expanded outer diameter of the hypotube to a contracted outer diameter less than the expanded outer diameter, and the end of the hypotube includes a flared portion having a terminal outer diameter exceeding the contracted outer diameter.

5. The occlusive device of claim 4, wherein the outer diameter of the expanded portion is at least as large as the enlarged outer diameter.

6. The occlusive device according to claim 1, further comprising: Filling inside the hypotube.

7. An occlusive device according to claim 6, wherein the filler comprises an absorbent material.

8. The occlusive device according to claim 7, wherein the filler further comprises another substance.

9. The occlusive device of claim 8, wherein the other substance is eluted from the absorbent material over time when the other substance is present in the subject.

10. The occlusive device of claim 8, wherein the another substance comprises at least one of a contrast agent, a drug, and a therapeutic agent.

11. An occlusive device according to claim 1, wherein the first part of the sea wave tube includes a first pillar, and when the sea wave tube expands, the first pillars move a first distance relative to each other, and the second part of the sea wave tube includes a second pillar, and when the sea wave tube expands, the second pillars move a second distance relative to each other, and the first distance is greater than the second distance.

12. The occlusive device of claim 1, wherein the final shape is a coil-like shape.

13. The occlusive device of claim 1, wherein the final shape is approximately spherical.

14. The occlusive device of claim 1, wherein the final shape has a length of at least 6 mm and an outer diameter of at least 6 mm.

15. A delivery system for an occluding device according to any one of claims 1 to 14, the delivery device comprising: a delivery device having a lumen; as well as A control wire positionable within a lumen of a delivery device and comprising a distal end having: a constrained state in which the distal end is constrained within the lumen of the delivery device and engaged with the occluding device to facilitate movement of the occluding device along at least a portion of the length of the lumen; as well as An expanded state, in which it is expanded outside the lumen of the delivery device and engages with the occluding device.

16. The delivery system according to claim 15, further comprising: A slider is associated with the delivery device and the control wire, the slider being designed to facilitate movement of the control wire within the distal and proximal ends of the lumen of the delivery device.

17. A method for blocking a passage or space in a subject, comprising: Introducing the occluding device according to any one of claims 1 to 14 into a target location in a subject in a restrained state, comprising: introducing a delivery device into a subject, the delivery device comprising an occlusion device and a portion of a control line; advancing the distal tip of the delivery device to the target location; advancing the control wire distally through the delivery device, the distal end of the control wire advancing the occluding device distally until the occluding device exits from the distal tip of the delivery device; When the occluding device is introduced into the target site: the outer diameter of the hypotube that expands the occlusive device so that the occlusive device is in an expanded state; and forming the occlusive device into a final shape; and Once the occlusive device is inflated and positioned at the target location: withdrawing the control wire from the proximal end of the delivery device, including withdrawing the distal end of the control wire from within the occluding device; and The delivery device is withdrawn from the subject.

18. The method of claim 17, wherein introducing the occluding device into the target location comprises: providing an occluding device in the lumen of the delivery device; as well as A control wire is arranged in the lumen of the delivery device, and the distal end of the control wire is located inside the occluding device.

19. The method of claim 17, further comprising, when introducing the occluding device into the target location: When the portion of the occlusion device in which the distal end of the control wire is located is moved away from the distal tip of the delivery device, the distal end of the control wire is expanded.

20. The method of any one of claims 17 to 19, wherein withdrawing the control line through the proximal end of the delivery device comprises: Pulling the expanded occluding device toward the distal tip of the delivery device and withdrawing the distal end of the control wire from the interior of the occluding device includes continuing to pull the control wire proximally from the interior of the occluding device back to the lumen of the delivery device.

Images