Closure device with self-expanding support

Abstract

The self-expanding occlusion device includes a hypotube. The outer diameter of the occlusion device self-expands or increases, and the occlusion device automatically assumes its final shape after deployment to the target location. The occlusion device can maintain its increased outer diameter and final shape while the occlusion device remains exposed to one or more conditions at the target location.

Description

[0001] Cross-references to related applications

[0002] Priority is claimed to U.S. Provisional Patent Application No. 63 / 072,926 (“'926 Provisional Application”), filed August 31, 2020, entitled “OCCLUSIVE DEVICE WITH MULTIPLESELF EXPANDING STRUTS, SHAPES, and METHODS”. The entire disclosure of the '926 Provisional Application is incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to a self-expanding device for sealing voids and channels (e.g., arteries, veins, other blood vessels, cavities, and other similar structures) within a subject's body. More specifically, this disclosure relates to a self-expanding occlusion device formed from a hypotube. Methods for sealing voids and channels within a subject's body, as well as methods of manufacturing, are also disclosed. Background Technology

[0004] Occlusion devices, including coils and plugs, are used for therapeutic and diagnostic purposes to slow or stop blood flow and seal other cavities in the subject's body. FIG. 1A and 1B Images of the same vascular system before and after placement of the occlusion device illustrate the effect of the occlusion device on the subject's vascular system. Occlusion devices can be used for a variety of purposes, including treating arteriovenous malformations, bleeding, perforation, aneurysms, tumors (e.g., vascular occlusion), varicose veins, congestion, and other conditions.

[0005] Occlusion devices, such as coils and plugs, are typically self-expanding devices designed to be confined within a loading device and then propelled through a tubular catheter, sheath, needle, cannula (each a "delivery device"), or other similar device to the target location, then exiting the tip of the delivery device and self-expanding to facilitate therapeutic occlusion. Metal-based coils and plugs are more common than polymer-based ones. Some coils and plugs incorporate polymers, fibers, coatings, fabrics, marking tapes, and other features on the exterior of metal or polymer stents, between stent features, and / or near or away from stent features.

[0006] FIG. 2A and 2B , from White, Ken, Cloft, and Kallmes, "Colis in a Nutshell: A Review of Coil Physical Properties," AJNRAugust 2008 ("White"), describes a specific design for a plug device that includes a coil. The coil shown in FIG. 2 includes a thin solid wire 1° (primary structure, or "primary wire") having a wire diameter D1. The thin solid wire 1° is formed into a coiled wire 2° (secondary structure, or "secondary spring" and / or "primary coil") having a coiled wire diameter D2. The coiled wire 2° is formed into a coiled tube 3° (tertiary structure) having an expandable diameter D3.

[0007] The coiled wire diameter D2, or more specifically, the outer diameter (OD) of the coiled wire 2°, defines the catheter delivery size of the coil. For example, a coil designed for a 0.018 inch delivery catheter has a coiled wire diameter D2 of about 0.018 inch OD; a coil designed for a 0.035 inch delivery system typically has a coiled wire diameter D2 of about 0.035 inch OD. Manufacturers will typically list their products under a general category, noting "0.018 coils," "0.035 coils," and other sizes, referring to the coiled wire diameter D2 of their coils.

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

[0009] The coiled tube 3° represents the final expanded and unconstrained OD, or tertiary shape, of the coil. For example, a "0355 mm x 2 cm coil" has a coiled wire diameter D2 of 0.035 inch, an unconstrained expandable diameter D3 of 5 mm, and a length of 2 cm. In clinical use, there is a difference between manufacturers as to how to size the coil for placement in the target anatomy. For example, the Ruby (Penumbra) and Azur CX (Terumo) coils should not be oversized relative to the anatomy size - a 5 mm expandable diameter D3 coil should be placed in a 5 mm internal diameter (ID) vessel. However, Boston Scientific and Medtronic recommend that clinicians oversize their Interlock and Concerto coils by 10-20%, so a 5.5 or 6 mm expandable diameter D3 coil should be placed in a 5 mm ID vessel. Certain plug sizes are recommended to be oversize by 30-50%.

[0010] Plug devices, including coil-shaped plug devices, can be manufactured to form any of a number of different tertiary shapes upon deployment, such as the coiled tube 3° shape or a symmetric helical shape (as shown in FIG. 2A and 3A ), as well as various other shapes, including the asymmetric helical shape shown in FIG. 3B , FIG. 3C and 3D the funnel shape shown in FIG. 3E , the sphere shown in

[0011] The tertiary shape of the occlusive device (e.g., coil) can enable it to perform a particular function, such as primary occlusion, framing, packing, wrapping, or other occlusive function. Wrapping and packing coils can be used inside or near a coil providing primary occlusion (e.g., behind, etc.). Wrapping and packing coils can also be used within a void (e.g., aneurysm sac, etc.), as shown in FIG. 4 Framing coils can frame a target, such as a void neck (e.g., aneurysm neck, etc.), to enclose a wrapping and / or packing coil within the void or to enclose embolic material within the void.

[0012] While existing occlusive devices are useful, the occlusion they provide is limited to the extent that their basic structure and any coating or adjunct material on their basic structure can be packed together, as the occlusive device assumes its tertiary shape. SUMMARY

[0013] An occlusive device according to the present disclosure includes, consists essentially of, or consists of a self-expanding body. The body is capable of expanding in a manner that enlarges its outer diameter (OD) (i.e., a first degree of expansion) and enables the hypotube to assume a predetermined tertiary shape, or its desired occlusive shape or final shape (i.e., a second degree of expansion).

[0014] In certain embodiments, the body of the occlusive device can include a hypotube having an expandable portion. The expandable portion can include a plurality of slits defining struts. The slits can be arranged in a manner that allows the hypotube to expand from its natural outer diameter to an expanded outer diameter. The hypotube can also be shaped in a manner that ultimately enables it to expand to its predetermined final shape or its desired occlusive shape.

[0015] The hypotube of the occlusive device can be formed of a substantially rigid material that can be constrained into a shape that facilitates its insertion into and / or removal from a subject's body but expands upon removal of the constraining force. Without limitation, the hypotube can be made of a metal (e.g., nitinol, stainless steel, etc.) or a polymer (polyether ether ketone (PEEK), etc.). The hypotube can be made of a shape memory material. In certain embodiments, including but not limited to those in which the hypotube is made of a shape memory material, the occlusive device can assume the desired shape or its final shape upon exposure to conditions (e.g., temperature, humidity, etc.) at the intended target location and removal of any constraining force.

[0016] In certain embodiments, multiple rows of slits can be defined along the length of the expandable portion of the hypotube of the occlusion device. Each row of slits can be positioned along a generator 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, parallel to the axis of the expandable portion). Alternatively, each row of slits can be oriented somewhat helically around the hypotube. The slits of each row can be offset from the slits of adjacent rows. Each slit can overlap approximately half of the slits of an adjacent row (if the slit is located at or near an end of the hypotube or thereabout) or two (if the slit is located in the middle); in other words, the slits of the expandable portion can have a so-called "brick-laid" arrangement, or they can be arranged like bricks in a so-called "running bond pattern." This arrangement of slits and struts defined by the slits of adjacent rows can cause the expandable portion of the hypotube to assume a desired final shape (e.g., a symmetric helix, an asymmetric helix, a funnel, a modified funnel, a sphere, or any other desired shape).

[0017] In certain embodiments, the arrangement of slits of the expandable portion of the hypotube of the occlusion device can enable the struts to twist and / or bend or rotate as the expandable portion or a portion thereof expands. This arrangement can also enable the expanded section of the expandable portion to return to its unexpanded state once an appropriate constraining force is applied to the hypotube (e.g., when an external force constrains the hypotube in the tube, the diameter of the tube will decrease and the rotating struts will rotate back to a flat, non-rotating position, etc.). With such an arrangement, the expandable portion can have a smooth outer surface when it is in a constrained or unexpanded state.

[0018] Manufacture of the occlusion device according to the present disclosure can include cutting slits in the wall of the hypotube at appropriate locations. The hypotube can be loaded onto a mandrel to form the hypotube into a desired shape. The desired shape of the hypotube, and thus of the occlusion device, can be set (e.g., by heating, etc. when the hypotube is formed of nitinol). A constraining force can then be applied to the hypotube or occlusion device to cause it to retract or collapse. The constraining force can collapse the hypotube to a shape and size that facilitates its storage and subsequent insertion into a subject. In certain embodiments, the occlusion device can be constrained within a loading device.

[0019] When a closure device is needed, it can be introduced into the body of a subject. For example, a catheter can be advanced to a desired location in the body of a subject. The closure device can be introduced into the proximal end of the catheter and advanced through the lumen of the catheter to the desired location. When the closure device exits the distal tip of the catheter at the desired location, it can automatically assume its increased outer diameter and intended final shape, and thus at least partially occlude the desired location in the desired manner. Conditions at the target location (e.g., temperature, etc.) can enable the closure device to self-expand and automatically assume its final shape, and / or cause the closure device to maintain its increased outer diameter and final shape while it remains exposed to the condition(s) at the target location.

[0020] Other aspects of the disclosed subject matter will become apparent from consideration of the following description, the accompanying drawings, and the ensuing claims. BRIEF DESCRIPTION OF DRAWINGS

[0021] In the drawings:

[0022] FIG. 1A and 1B are images of the same vasculature before (Fig. 1) and after (Fig. 2) placement of a closure device, and show the effect of the closure device on the vasculature of the subject. FIG. 1A FIG. 1B

[0023] FIG. 2A and 2B depict features of existing closure devices including coils;

[0024] FIG. 3A show embodiments of coiled closure devices including symmetric spirals;

[0025] FIG. 3B show embodiments of coiled closure devices including asymmetric spirals;

[0026] FIG. 3C show embodiments of coiled closure devices including funnels;

[0027] FIG. 3D show embodiments of coiled closure devices including modified funnels;

[0028] FIG. 3E show embodiments of coiled closure devices including slightly spherical or spherical shapes;

[0029] FIG. 4 illustrate a closure device within an aneurysm sac;

[0030] FIG. 5A to 5D ​​An embodiment of a closure device is depicted, having a body comprising an expandable portion having an expandable and contractible outer diameter (OD);

[0031] FIG. 6A-1 and 6A-2 respectively provide an end view and an isometric view of a conventional closure device in its final shape;

[0032] FIG. 6B-1 and 6B-2 respectively provide an end view and an isometric view of an embodiment of a closure device of the present disclosure, in its final shape, its body being in an unexpanded state;

[0033] FIG. 6C-1 and 6C-2 respectively provide FIG. 6B-1 and 6B-2 an end view and an isometric view of an embodiment of a closure device as shown, in its final shape, and its body being in an expanded state;

[0034] FIG. 7B provide FIG. 6B-1 and 6B-2 a detailed end view of an embodiment of a closure device as shown, its body being in FIG. 6B-1 and 6B-2 an unexpanded state;

[0035] FIG. 7C provide FIG. 6C-1 and 6C-2 a detailed end view of an embodiment of a closure device as shown, its body being in FIG. 6C-1 and 6C-2 an expanded state;

[0036] FIG. 8 are isometric views of variants of an embodiment of a closure device as shown in FIG. 6C-1 , 6C-2 and 7C, its body being in FIG. 6C-1 , 6C-2 and 7C, an expanded state, and at least one of its ends being tapered;

[0037] FIG. 9A-9C are respectively a side view, a cross-sectional view and an oblique view of another embodiment of a closure device according to the present disclosure, having a slightly spherical shape;

[0038] FIG. 10 show FIG. 9A to 9C a variant of an embodiment of a closure device as shown, in which the struts of the expandable portion of the body of the closure device have jagged edges;

[0039] FIG. 11 depicts another final shape of a closure device according to the present disclosure;

[0040] FIG. 12 An embodiment of a sealing device having an expandable coating and / or filling material is illustrated;

[0041] FIG. 13 The illustration shows an embodiment of a sealing device including a fabric or film covering; and

[0042] FIG. 14 An embodiment of a method for deploying an occlusion device at a target location within a subject is described. Detailed Implementation

[0043] refer to FIG. 5A to 5D An embodiment of the occlusion device 10 is depicted. The occlusion device 10 is shown in an unexpanded or restrained state, which facilitates its introduction into and / or removal from the subject. FIG. 5A As shown, the sealing device 10 can extend under constrained conditions.

[0044] The sealing device 10 includes a body 12. The body 12 may be formed from any one or a combination of suitable materials. In some embodiments, the entire body 12 may be defined as being formed of or comprising a thiopanole, which may be formed of a substantially rigid material, such as a metal. Examples of suitable metals include, but are not limited to, shape memory alloys (e.g., nitinol, etc.), cobalt-chromium (CoCr), nickel-chromium (NiCr or nickel-chromium alloys) alloys (including, but not limited to, NiCr steel), stainless steel (e.g., 316L stainless steel, 316 stainless steel, etc.). Alternatively, the body 12 may be formed of a polymer. Suitable polymers may have sufficient hardness (e.g., at least 35 Shore hardness, 35 Shore hardness to 55 Shore hardness, 35 Shore hardness to 72 Shore hardness, etc.). Examples of suitable polymers include, but are not limited to, polyetheretherketone (PEEK), polyimide, nylon, polyether block amide (PEBA, e.g., brand name...). Those) and extruded plastics (provided their wall thickness does not exceed the width of their strut 36, as described below).

[0045] The expandable portion 30 of the main body 12 of the sealing device 10 may be able to remain in a non-expanded state (e.g. FIG. 5A The expandable portion 30 expands outward (e.g., radially outward) to an expanded state and final shape. For example, in an embodiment where the body 12 is formed of a shape memory material (such as a shape memory alloy), the expandable portion 30 can expand to its final shape when exposed to appropriate conditions (e.g., human body temperature). 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 when the restraint is removed from the body 12.

[0046] like FIG. 5B to 5DAs shown, the expandable portion 30 can be defined by a series 34a, 34b, 34c, etc. of slits 32 that extend at least partially through the wall of the body 12. In certain embodiments, each slit 32 can extend completely through the wall of the body 12, from an outer surface thereof to an inner surface thereof. In other embodiments, each slit 32 can extend only partially through the wall of the body 12 (e.g., from an outer surface of the wall toward an inner surface of the wall, etc.). The extent to which each slit 32 extends through the wall of the body 12 can depend at least in part on the material from which the body 12 is formed.

[0047] The slits 32 (except for some of the slits 32 located at the ends of the expandable portion 30) can have the same length as one another. Adjacent slits 32 (in the form of series 32a, 32b, 32c, etc.) are separated by solid, uncut regions of the body 12. These solid regions can be referred to as joints 38 or connection points.

[0048] Each series 34a, 34b, 34c, etc. can be defined by linearly aligned slits 32. The slits 32 and each series 34a, 34b, 34c, etc. can extend longitudinally along the body 12, each series 34a, 34b, 34c, etc. being disposed along a generator 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). Such an orientation can be referred to as a "straight" orientation. Alternatively, each series 34a, 34b, 34c, etc. can be oriented helically about the body 12.

[0049] The slits 32 of each series 34b, 34c, 34d, etc. can be offset relative to the slits 32 of each adjacent series 34a, 34b, 34c, 34d, 34e, etc. Each slit 32 in a series 34a, 34b, 34c, etc. can overlap about one-half of the slits 32 of each circumferentially adjacent series 34a, 34b, 34c, etc. if the slit 32 is located at or near an end of the expandable portion 30, or can overlap about one-half of the slits 32 of two circumferentially adjacent series 34a, 34b, 34c, etc. if the slit 32 is located intermediate along the length of the expandable portion 30. The staggered arrangement of the slits 32 about the circumference of the expandable portion 30 of the body 12 can provide the expandable portion 30 with a so-called "brick-laid" appearance, with the solid portions of the body 12 between the slits 32 being arranged in a so-called "running bond" pattern.

[0050] Circumferentially adjacent continuous portions 34a, 34b, 34c, etc. of slits 32 can be equidistantly spaced around the circumference of body 12. Expandable portion 30 can include an even number of circumferentially adjacent continuous portions 34a, 34b, 34c, etc. of slits 32. In embodiments where circumferentially adjacent continuous portions 34a, 34b, 34c, etc. of an even number of slits 32 are equidistantly spaced around the circumference of body 12, each slit 32 of expandable portion 30 can be staggered relative to its circumferentially adjacent slit 32. Alternatively, the distance between slits 32 of one circumferentially adjacent continuous portion 34a can be different than the distance between slits 32 of another circumferentially adjacent continuous portion 34c; thus, the number of slits 32 of one circumferentially adjacent continuous portion 34a can be different than the number of slits 32 of another circumferentially adjacent continuous portion 34c.

[0051] The solid portions of body 12 between each pair of adjacent continuous portions 34a and 34b, 34b and 34c, 34c and 34d, etc. of slits 32 comprise struts 36 of expandable portion 30. More specifically, each strut 36 can comprise the solid portion of body 12 between adjacent continuous portions 34a and 34b, 34b and 34c, 34c and 34d, etc. of slits 32. In other words, each slit 32 comprises a gap between a pair of circumferentially adjacent struts 36. In embodiments where continuous portions 34a, 34b, 34c, etc. are oriented along a longitudinal axis of body 12, struts can also be oriented along the longitudinal axis of the body; in embodiments where continuous portions 34a, 34b, 34c, etc. are oriented helically around body 12, struts 36 can also be oriented helically around body 12 or as a helix.

[0052] Staggering of slits 32 can cause expandable portion 30 to expand. In certain embodiments, struts 36 can rotate as expandable portion 30 expands. This rotation can occur, for example, in embodiments where each ring of circumferentially aligned struts 36 around expandable portion 30 comprises an even number of struts 36. As the slits rotate, they project outwardly (e.g., radially, etc.) from the circumference of expandable portion 30, which can secure occlusive device 10 in place.

[0053] In other embodiments, slits 32 are not staggered and struts 36 do not rotate as expandable portion 30 expands. In such embodiments, the resulting occlusive device 10 can still expand to create multiple points of contact with the walls of the vessel or void in which occlusive device 10 resides, thereby securing occlusive device 10 in place within the vessel or void.

[0054] The expandability provided by the slit 32 and the support 36 of the expandable portion 30 of the body 12 of the sealing device 10 allows 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 take on a predetermined three-stage shape, or a desired sealing shape or final shape, providing a second degree of expansion.

[0055] Figures 6A to 6C compare the final shape of the conventional sealing device 110. FIG. 6A-1 and 6A-2 The sealing provided by a single degree of expansion during the expansion of the sealing device 10 according to this disclosure, and the sealing provided by the single degree of expansion during the expansion and formation of its final shape during the expansion of the sealing device 10 according to this disclosure. FIG. 6B-1 to 6C-2 The blockage provided by two or more degrees of expansion. FIG. 6A-1 An end view of an embodiment of a conventional plugging device 10' (e.g., a coil of 0.355 mm x 2 cm) is provided, which includes a coiled wire 112 already wound into its final shape, which is also a coil of the conventional plugging device 110, such as... FIG. 6A-2 As shown. This conventional coiled occlusion device 110 reduces the area of ​​the lumen it occupies (e.g., a blood vessel, etc.) by approximately 59%. Notably, the outer diameter of the coiled wire 112 does not increase.

[0056] FIG. 6B-1 and FIG. 7B An end view of an embodiment of the blocking device 10 of this disclosure is provided, with its body 12 in an unexpanded state but exhibiting a final coiled shape, as shown in FIG6B (e.g., a 0.355 mm x 2 cm coil). The original dimensions of the body 12 of the blocking device 10 (e.g., its OD, etc.) may be the same as or substantially the same as the corresponding dimensions of the coiled wire 112 of a conventional blocking device 110 (e.g., an OD of 0.035 inches or 0.89 mm, etc.).

[0057] Although the outer diameter of the coiled wire 112 of the conventional sealing device 110 does not expand, such as FIG. 6C-1 , 6C-2 As shown in 7C, but the outer diameter of the body 12 of the blocking device 10 of this disclosure can be expanded (e.g., doubled, such as by 0.070 inches or 1.8 mm). FIG. 7C As shown, the main body 12 expands as the slit 32 in the main body 12 opens gradually around the circumference of the main body 12. (As indicated...) FIG. 6C-2 As shown, as the body 12 expands, the volume occupied by the body 12 increases, thereby enabling the sealing device 10 to provide improved sealing as it takes on its final shape (e.g., the sealing device 10 can reduce the area of ​​the cavity in which it is located by at least about 75%, at least about 80%, at least about 85%, at least about 90%, about 92%).

[0058] likeFIG. 8 As shown, the outer diameter of one or both end portions 16, 17 of the main body 12 of the occlusion device 10 can be the same as the outer diameter along the remainder (central portion) of the main body 12 when the main body 12 is in its expanded state, and / or one or both end portions 16, 17 can have a constricted outer diameter (e.g., it can taper at its end, at a location adjacent to its end, etc.). In the illustrated embodiment, the outer diameter of the end portion 16 is the same as the outer diameter of the bulk of the main body 12 (e.g., an outer diameter of 0.070 inches or 1.8 mm, etc.), while the end portion 17 tapers to a smaller outer diameter (e.g., an outer diameter of 0.035 inches or 0.89 mm, etc.).

[0059] When expanded to its final shape, the occlusion device 10 can assume any of a variety of different predetermined shapes. Such final shapes include, but are not limited to FIG. 3A to 3E the shape shown. FIG. 11 An embodiment of an occlusion device having a diamond or double funnel shape is depicted.

[0060] FIG. 9A to 9C A view of an embodiment of an occlusion device 10' including a plug is provided, which when placed in its fully expanded state (i.e., the main body 12' of the occlusion device 10' is expanded and allowed to assume its final shape), assumes a final shape that is slightly spherical. As shown, the struts 36' can rotate outward (e.g., up to about 90°, etc.) when the main body 12' is in its expanded state, which can cause the occlusion device 10' to engage the tissue (e.g., the vessel intima, etc.) against which it is positioned and expanded. Without limitation, the diameter of the final shape can be up to about 5 mm. FIG. 10 An occlusion device 10" is shown that is a variation in which the slits 32" define struts 36" having jagged edges.

[0061] A particular embodiment of an occlusion device 10 according to the present disclosure can expand from an outer diameter of, for example, about 0.035 inches (about 0.89 mm) to an outer diameter of about 0.070 inches (about 1.8 mm). Such an occlusion device 10 having a symmetric spiral final shape (dimensions of about 5 mm x 2 cm) can have 50% less metal mass than a conventional occlusion device 10 having an outer diameter of about 0.035 inches (about 0.89 mm) and the same final shape. For example, a standard 0355 mm x 2 cm coil having a 0.005 inch (0.13 mm) wire has a metal volume of 2.387 mm 3 / cm, while a 0355 mm x 2 cm coil occlusion device 10 formed according to the present disclosure as a hypotube with a wall thickness of 0.0018 inches (0.046 mm) has a metal volume of 1.015 mm 3The metal volume is approximately 1 / cm². Therefore, compared to the mass of conventional plugging devices of similar size, the plugging device 10 of this disclosure can reduce the metal volume and mass by approximately 50% to approximately 80%.

[0062] Reducing the metal mass will reduce computed tomography (CT) artifacts after the occlusion device 10 is implanted in the subject. Due to the size or location of CT artifacts produced by such conventional occlusion devices, some subjects using existing conventional occlusion devices cannot be effectively imaged by CT for future follow-up. Therefore, subsequent invasive angiography may be required. By reducing CT artifacts, subjects receiving the metal occlusion device 10 according to this disclosure may be able to undergo CT scans for future follow-up.

[0063] In some embodiments, the sealing devices 10, 10', 10″, 10″′, 10″″, etc. (hereinafter referred to as sealing device 10 for simplicity) according to this 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 filler material). The coating and / or filler can provide further closure. The coating may extend on the outer surface of the body 12, 12', 12″, 12″′, 12″″, etc. (hereinafter referred to as body 12 for simplicity) of the sealing device 10. The filler may be confined by the inner lumen of the tube defining the body 12 of the sealing device 10. In some embodiments, the coating and / or filler may be bonded to the body 12.

[0064] As an example, the coating and / or filler may include an expandable hydrogel that expands after the sealing device 10 is placed to increase the filler volume and packing density. As another example, such as FIG. 12 As shown, the sealing device 10″′ may be equipped with an expandable polymer foam or mesh 40, which may be formed of a shape memory polymer (SMP), such as polyurethane SMP (e.g., N,N,N',N'-tetra(2-hydroxypropyl)ethylenediamine (HPED); 2,2',2″-triethanolamine (TEA); hexane 1,6-diisocyanate (HDI); trimethylhexamethylene diisocyanate (a mixture of 2,2,4- and 2,4,4- positions) (TMHDI), etc.). In another example, the sealing device 10 may be provided with flexible filaments that may be located within the cavity of the body 12 and extend through the slit 36 ​​( FIG. 5B-5D ), and / or disposed on the outer surface of the body 12. As another example, such as FIG. 13 As shown, a fabric (e.g., PTFE, etc.) or a film 50 (e.g., a polymer film, etc.) may cover at least a portion (e.g., its outer and / or inner surfaces, etc.) of the body 12″″ of the sealing device 10′″″ to prevent fluid from flowing through the open slit 36″″ in the body 12″″. FIG. 5B-5D ).

[0065] In addition to, or in lieu of, enhancing the occlusive capabilities of the occlusive device 10, the coating and / or filler can impart additional properties to the occlusive device 10. For example, the coating and / or filler can absorb fluid from the subject's body, which can facilitate embolization.

[0066] In another example, the filler can impart radio-opacity to the occlusive device 10. Such a filler can be incorporated into the body 12 to enable the filler to expand with and / or within the body 12 and to prevent the filler from migrating out of the body 12 in its expanded state. Such a filler can include cotton, nylon, fibers, filaments, and / or another suitable material. The filler can be absorbable. In certain embodiments, the filler can be manufactured with a radio-opaque material (e.g., tungsten, barium, iodine, bismuth trioxide (bismuth (III) oxide and / or Bi2O3), etc.) and / or other materials that facilitate x-ray visualization.

[0067] The filler can carry (e.g., absorb, etc.) a substance to be delivered to a target site within the subject's body. Examples of substances that the filler can carry include, but are not limited to, a contrast agent, a drug, etc., which can be applied to the filler during manufacture or by a clinician during a procedure prior to deployment, during deployment, or after deployment.

[0068] A clinician can inject a substance into a transport and storage tube containing the occlusive device 10 prior to loading the occlusive device 10 into a catheter for delivery into the subject's body. Any filler in the occlusive device 10 can absorb or otherwise carry the substance. In embodiments in which the substance includes a contrast agent, the contrast agent will be radio-opaque under fluorescent x-rays to guide into place as the occlusive device 10 is pushed through the catheter to the target location and as the occlusive device 10 is deployed at the target location. After deployment, the contrast agent can dissipate, elute, and / or wash away from the occlusive device 10. This allows the occlusive device 10 to be seen during placement, but reduces x-ray visualization after placement, which can be beneficial for viewing adjacent anatomy and pathologies. In embodiments in which the substance includes a drug, a therapeutic (e.g., oncolytic, a radioisotope such as yttrium 90 (Y90), etc.), a nutrient, a diagnostic reagent, a marker, a targeting compound, etc., the substance can be eluted once the occlusive device 10 is placed at the target location.

[0069] Optionally, a clinician can deploy the occlusive device 10 (with or without a filler) and inject a substance into a catheter that is delivering the occlusive device 10 prior to or concurrently with the occlusive device advancing along the catheter. This can allow the clinician to inject the substance into the catheter as the occlusive device 10 is pushed through the catheter, but to dissipate the substance after the occlusive device 10 has been placed at its target location.

[0070] Alternatively, the substance can be introduced through a catheter and into the occlusion device 10 or its fill material after the occlusion device 10 is deployed.

[0071] The substance can also be applied directly to the body 12 of the occlusion device 10 (e.g., to one or more of the struts 36 thereof, etc.). The substance can be bonded, painted, adhered, or otherwise applied to the body 12 of the occlusion device 10. Alternatively, a band carrying the substance (e.g., a radiopaque band, etc.) can be crimped onto one or more of the struts 36 and / or one or both of the end portions 16, 17 of the body 12.

[0072] In certain embodiments, the occlusion device 10 can include a sensor. The sensor can include a passive sensor or an active sensor. The sensor can be located in or affixed to the body 12 of the occlusion device 10. In certain embodiments, the sensor can include a radio frequency identification sensor or chip.

[0073] Methods of manufacturing the occlusion device 10 can use a hypotube (e.g., a nitinol hypotube having an outer diameter of 0.035 inches (0.89 mm) and an inner diameter of ~0.030 inches (~0.76 mm), etc.). The slits 32 FIG. 5B-5D ) can be cut into the hypotube by any suitable process (e.g., by laser cutting, mechanically (e.g., by computer numerical control (CNC) machining, etc.), by electrical discharge machining (EDM), by chemical etching, etc.). The slits 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 slits 32 can not extend to locations of the hypotube (e.g., to one or both of its end portions, to one or more intermediate locations, etc.) that are not expected to expand or remain constrained when the occlusion device 10 is deployed. The constrained locations can serve a variety of purposes, such as retaining material inside the occlusion device 10, providing a connection point for a deployment mechanism that facilitates deployment and / or positioning of the occlusion device 10, or connecting the occlusion device 10 to another occlusion device.

[0074] Cutting the slits 32 of the hypotube can result in the struts 36 having a blunt edge or the struts 36 having a sharp edge. Additionally, the cutting of the slits can include a defined feature along the edge of the struts 36, such as a tooth, a serration, an edge roughness, etc. Such features can enable the resulting occlusion device 10 to be fixed in place at a target location in the body of a subject, which can facilitate an endothelial and / or thrombogenic response and / or otherwise prevent migration of the occlusion device 10 after it has been positioned at the target location.

[0075] The edges of the struts 36 defined by the slits 32 can be modified after the slits 32 are cut. In certain embodiments, the edges can be polished. In other embodiments, the edges can be sharpened.

[0076] Other features can also be cut into the hypotube. For example, slots, holes, channels, or other features can be cut into one or both of the ends 16, 17 of the hypotube and / or one or more of the struts 36. These features can be related to a deployment mechanism (e.g., a detachable pusher, etc.). In particular embodiments, one or more circular (e.g., 0.003 inch or 0.076 mm diameter, etc.) notches or channels can be formed in the end 16 of the hypotube; these notches or channels can accommodate extendable / retractable, circular (e.g., 0.003 inch (0.076 mm) or smaller diameter) male features of a deployment mechanism. This connection can be robust enough for a user to push or pull the occlusion device 10 through a delivery device 200 (e.g., a catheter, sheath, sleeve, needle, etc.). FIG. 14

[0077] The cut hypotube can then be loaded onto a mandrel (e.g., a hard steel mandrel) having a desired shape (e.g., a tapered straight, a helical, a funnel, etc.). The hypotube can expand when loaded onto the mandrel, thereby increasing its inner and outer diameters (e.g., to about 0.075 inches or about 1.9 mm). The expansion of the cut hypotube can cause the slits 32 of the hypotube to open and the struts 36 of the hypotube to be exposed. FIG. 5B-5D The expanded, cut hypotube can then be heated to a sufficient temperature (e.g., about 400 °C to about 600 °C, etc.) for a sufficient duration of time (e.g., up to 1 hour, etc.) to solidify the nitinol in its expanded state. The hypotube can then be cooled; it can remain on the mandrel or it can be removed from the mandrel. The cooled hypotube can then be constrained back to its original outer diameter by physically squeezing the outer diameter and / or pushing the expanded hypotube into a funnel-like hypotube fixture that tapers down from an inner diameter of about 0.080 inches (about 2.0 mm) to about 0.035 inches (about 0.89 mm) or less. The constrained hypotube can then be loaded (e.g., pushed into, etc.) into a shipping 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) outer diameter, 0.018 inch (0.46 mm) outer diameter, 0.025 inch (0.64 mm) outer diameter, 0.027 inch (0.69 mm) outer diameter, and other outer diameters, inner diameters, and lengths.

[0078] Reference is now made to FIG. 14 ​The method of using the occlusion device 10 includes advancing a distal tip 202 of a delivery device 200 (e.g., a catheter, sheath, cannula, needle, etc. as described) to a target location T within a subject. The occlusion device 10 can be transferred from a loading device (not shown) to a proximal end 204 of the delivery device 200. The occlusion device 10 can be advanced along the length of the delivery device 200 until it reaches the distal tip 202. As the occlusion device 10 emerges or is deployed from the distal tip 202, the occlusion device 10 can at least partially expand and can be positioned against a surface of the target location T (e.g., against an endovascular intima, etc.). The position of the occlusion device 10 can be maintained within the subject (e.g., at the target location T, etc.) by pushing the constrained occlusion device 10 distally out of the distal tip 202 and / or pulling the delivery device 200 proximally, e.g., using a deployment mechanism 210, etc.

[0079] Once the occlusion device 10 has fully deployed from the distal tip 202, it can assume its final shape.

[0080] Once the occlusion device 10 is clear of the delivery device 200, the deployment mechanism 210 can remain connected to the occlusion device 10. This can allow the clinician to confirm placement accuracy. Alternatively, the clinician can be able to push, pull, drag, or otherwise move the at least partially expanded occlusion device 10 (e.g., with the deployment mechanism 210, etc.) in a manner that positions the occlusion device 10 at the target location T. Such movement can also denude, agitate, or mechanically stimulate the intima at the target location T to induce an inflammatory response (with or without injection of any sclerosing agent), which can promote temporary or permanent fixation of the occlusion device 10 at the target location T, and thus temporary or permanent occlusion.

[0081] If placement accuracy is acceptable, the deployment mechanism 210 can be detached from the occlusion device 10 (e.g., by retracting the extendable / retractable circular male feature of the deployment mechanism 210 to separate the deployment mechanism 210 from the occlusion device 10.

[0082] Without limitation, occlusion devices 10 according to the present disclosure can be used to promote luminal filling, reduce flow, improve thrombosis, improve hyperplasia, reduce x-ray density, or otherwise promote occlusion. Such occlusion devices 10 can be used in conjunction with a variety of conditions, including but not limited to arteriovenous malformations, hemorrhage, perforation, aneurysm, myoma, varix, hyperemia, distal embolization, and other conditions. Occlusion devices 10 can be used to treat COVID-19 patients who present with elevated D-dimer levels (a fragment of fibrinogen found in blood tests that indicates a blood clotting disorder) and life-threatening thrombi in the heart, lungs, brain, and peripheral thrombi. Hemorrhage is a complication of thrombi that can be treated using an embolization device. See, e.g.,

[0083] https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC7203058 /

[0084] https: / / www.medicalnewstoday.com / articles / covid-19-ive-never-seen-such-sticky-blood-says-thrombosis-expert

[0085] https: / / www.sciencedaily.com / releases / 2020 / 06 / 200630125129.htm

[0086] https: / / pubmed.ncbi.nlm.nih.gov / 32339221 /

[0087] https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC7146714 /

[0088] https: / / pubmed.ncbi.nlm.nih.gov / 32316063 /

[0089] https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC7225095 /

[0090] https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC7229939 /

[0091] https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC7255402 /

[0092] https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC7177070 / ,

[0093] The disclosures of which are incorporated herein by reference.

[0094] While the foregoing disclosure provides many details of the application, it should be understood that the language is intended to be illustrative only and not limiting since additional embodiments of the disclosed application will become apparent to the skilled artisan in light of the disclosure. The true scope of the application will be determined only by the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

1. An occlusion device comprising a hypotube that self-expands to an increased outer diameter and a final shape upon deployment to a target location within a subject's body, the hypotube comprising a plurality of rows of slits arranged in parallel along an axis of the hypotube, the slits in one row of the plurality of rows of slits being offset relative to an adjacent slit in an adjacent row of the plurality of rows of slits, thereby enabling the hypotube to self-expand to the increased outer diameter and the final shape, the slit and the adjacent slit defining a strut that rotates about a longitudinal axis of the strut during expansion of the hypotube to the increased outer diameter, the increased outer diameter and the final shape being capable of at least partially occluding a passageway through a portion of the subject's body.

2. An occlusion device comprising a hypotube that self-expands to an increased outer diameter and a final shape upon deployment to a target location within a subject's body, the hypotube comprising a plurality of rows of slits arranged in a spiral around the hypotube, the slits in one row of the plurality of rows of slits being offset relative to an adjacent slit in an adjacent row of the plurality of rows of slits, thereby enabling the hypotube to self-expand to the increased outer diameter and the final shape, the slit and the adjacent slit defining a strut that rotates about a longitudinal axis of the strut during expansion of the hypotube to the increased outer diameter, the increased outer diameter and the final shape being capable of at least partially occluding a passageway through a portion of the subject's body.

3. The occlusion device of claim 1 or 2, wherein the hypotube self-expands to the increased outer diameter and the final shape upon exposure to conditions within the subject's body.

4. The occlusion device of claim 3, wherein the hypotube self-expands to the increased outer diameter and the final shape upon exposure to body temperature.

5. The occlusion device of claim 1 or 2, wherein the hypotube comprises a shape memory material.

6. The occlusion device of claim 5, wherein the shape memory material comprises nitinol.

7. The occlusion device of claim 1 or 2, wherein the increased outer diameter of the hypotube is at least 100% of a constrained outer diameter of the hypotube.

8. The occlusion device of claim 1 or 2, wherein the final shape comprises a coil.

9. The occlusion device of claim 1 or 2, wherein the hypotube in the final shape occludes at least 75% of a cross-sectional area of the passageway through the portion of the subject's body, at least 80% of a cross-sectional area of the passageway through the portion of the subject's body, at least 85% of a cross-sectional area of the passageway through the portion of the subject's body, or at least 90% of a cross-sectional area of the passageway through the portion of the subject's body.

10. The occlusion device of claim 1 or 2, further comprising: a filler material within a lumen of the hypotube.

11. The occlusion device of claim 10, wherein the filler material comprises an absorbable material.

12. The occlusion device of claim 10, wherein the filler material comprises a radiopaque material.

13. A system for occluding a passageway or void within a subject's body with the occlusion device of any one of claims 1-12, comprising: a device for introducing the occlusive device in a constrained state into a target location in the subject; and a device for expanding the outer diameter of the hypotube of the occlusive device; and a device for allowing the occlusive device to assume a final shape.

14. The system of claim 13, wherein the device for introducing the occlusive device into the target location comprises a device for exposing the occlusive device to at least one condition that causes the outer diameter of the occlusive device to self-expand and the occlusive device to automatically assume a final shape.

15. The system of claim 13 or 14, wherein the device for introducing comprises: an insertion device; a device for advancing the occlusive device through the insertion device to the target location; and a device for separating the occlusive device from the device for advancing at the target location.

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