Occlusion device having self-expanding struts - Patent application

Abstract

A 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 when deployed at the target location. The occlusion device can retain its increased outer diameter and final shape when it remains exposed to one or more conditions at the target location.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS Priority is hereby claimed to U.S. patent application Ser. No. 17 / 686,359, filed March 3, 2022, entitled "OCCLUSIVE DEVICE WITH SELF-EXPANDING STRUTS" (the "'359" application). The entire disclosure of the '359 application is incorporated herein.

[0002] The present disclosure relates generally to self-expanding devices for occluding cavities and passageways (e.g., arteries, veins, other vessels, chambers, and other similar structures) within a subject's body. More particularly, the present disclosure relates to self-expanding occlusion devices formed from hypotubes. Methods of occluding cavities and passageways within a subject's body are also disclosed, as are methods of manufacture. [Background technology]

[0003] Occlusion devices, including coils and plugs, are used therapeutically and diagnostically to slow or stop blood flow and occlude other cavities in a subject's body. Figures 1A and 1B, which are images of the same vasculature before and after placement of an occlusion device, respectively, show the effect of the occlusion device on the vasculature of a subject. Occlusion devices can be used for a variety of purposes, including the treatment of arteriovenous malformations, hemorrhage, perforation, aneurysms, tumors (e.g., vascular resections, etc.), varicose veins, blood stasis, and other conditions.

[0004] Occlusion devices such as coils are typically self-expanding devices designed to be constrained within a loading device and then pushed through a catheter, sheath, needle, cannula (each a "delivery device") or other similar device to a target location and then exit the tip of the delivery device to self-expand 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 outside of a metal or polymer scaffold, between scaffold features, and / or proximal or distal to the scaffold features.

[0005] 2A and 2B, taken from White, Ken, Cloft, and Kallmes, "Coils in a Nutshell: A Review of Coil Physical Properties," AJNR, August 2008 ("White"), show a particular design of an occlusion device comprising a coil. The coil shown in FIGS. 2A and 2B 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 turn") having a coiled wire diameter D2. The coiled wire 2° is formed into a larger three-dimensional structure 3° (tertiary structure), such as a coiled tube as shown in FIG. 2B, having an expandable diameter D3.

[0006] The coil wire diameter D2, or more specifically the outer diameter (OD) of the coiled wire 2°, defines the catheter delivery size of the coil. As an example, a coil designed for a 0.018 inch (0.46 mm) delivery catheter will have a coil wire diameter D2 or OD of about 0.018 inch OD or about 0.46 mm, and a coil designed for a 0.035 inch (0.89 mm) delivery system will typically have a coil wire diameter D2 or OD of about 0.035 inch or about 0.89 mm. Manufacturers typically list their product offerings under broad headings such as "0.018 coils", "0.035 coils" and other sizes with reference to the coil wire diameter D2 of their coils.

[0007] As an alternative to the coiled wire 2°, a solid wire or a solid composite wire may be used for the coiled tube 3°.

[0008] The coiled tube 3° represents the final expanded, unconstrained OD, or tertiary shape of the coil. As an example, a "035 5mm x 2cm coil" has a coiled wire diameter D2 of 0.035 inches or 0.89mm, an unconstrained expandable diameter D3 of 5mm, and a length of 2cm. In clinical use, there is variation between manufacturers on how to size coils for placement within the target anatomy. For example, the Ruby coil (Penumbra) and Azur CX coil (Terumo) recommend that coils should not be oversized for the anatomy, and that a 5mm internal diameter (ID) vessel should have a 5mm expandable diameter D3 coil. However, Boston Scientific and Medtronic recommend that clinicians oversize their Interlock and Concerto coils by 10-20%, and therefore a 5mm ID vessel should have a 5.5 or 6mm expandable diameter D3 coil. It is recommended that certain coils be oversized by 30-50%.

[0009] Occlusion devices, including coil-shaped occlusion devices, can be manufactured to form any of a number of different tertiary shapes when deployed, such as the coiled tube 3° shape or symmetrical helical shape shown in Figures 2A and 3A, as well as a variety of other shapes, including the asymmetrical helical shape shown in Figure 3B, the funnel shape shown in Figures 3C and 3D, the ball shape shown in Figure 3E, and a variety of other shapes. These and other shapes are referred to in the art as coils.

[0010] The tertiary shape of an occlusion device, such as a coil, may enable the device to perform a specific function, such as primary occlusion, surrounding, filling, packing, or another occlusion function. Packing coils and filling coils may be used inside or adjacent to (e.g., behind) the coil that provides the primary occlusion. Packing coils and filling coils may also be used within a cavity (e.g., an aneurysm sac, etc.) as shown in FIG. 4. A surrounding coil may surround a target, such as the neck of a cavity (e.g., the neck of an aneurysm, etc.), to enclose the packing coil and / or filling coil within the cavity or to enclose embolic material inside the cavity.

[0011] While existing occlusion devices are useful, the occlusion they provide is limited by the extent to which the basic structure and any coatings or ancillary materials on the basic structure can be packed together when the occlusion device assumes its tertiary shape. Occlusion of a blood vessel typically requires the placement of five or more conventional occlusion devices in close proximity to one another within the vessel. Summary of the Invention [Means for solving the problem]

[0012] An occlusion device according to the present disclosure comprises, consists essentially of, or consists of a self-expanding body. The body may be expanded to expand its outer diameter (OD) (i.e., a first degree of expansion) to allow the hypotube to assume a predetermined tertiary shape, or its desired occlusion or final shape (i.e., a second degree of expansion). Such an occlusion device may be referred to as a "plug." As few as one or two plugs may be required to occlude a vessel.

[0013] In some embodiments, the body of the occlusion device may comprise a hypotube having an expandable section. The expandable section may include a plurality of slits that define struts. The slits may be positioned to allow the hypotube to expand from its native OD, or its unexpanded OD, to an expanded OD. The expanded OD of the occlusion device may be about two or even about three times its native OD. The hypotube may also be shaped to ultimately allow it to expand to its predetermined final shape or its desired occlusion shape.

[0014] The hypotube of the occlusion device may be formed from a substantially rigid material that may be constrained to a shape that facilitates insertion and / or removal from a subject's body, but may expand upon removal of the constraining force. Without limitation, the hypotube may be made from a metal (e.g., nitinol, stainless steel, etc.) or a polymer (e.g., polyetheretherketone (PEEK)). The hypotube may be formed from a shape memory material. In some embodiments, including but not limited to when the hypotube is made from a shape memory material, the occlusion device may assume a desired shape or its final shape upon exposure to conditions (e.g., temperature, moisture, etc.) at the intended target location and upon removal of the constraining force.

[0015] In some embodiments, multiple rows of multiple slits may be defined along the length of the expandable section of the hypotube of the occlusion device. Each row of slits may be positioned along a generatrix of the expandable section (e.g., a line parallel to the axis of the expandable section, extending from one end of the expandable section of the hypotube to the other end of the expandable section). Alternatively, each row of slits may be oriented somewhat helically around the hypotube. The slits in each row may be offset from the slits in the adjacent rows. Each slit may overlap approximately half of one slit in the adjacent row (if the slit is located at or near the end of the hypotube) or two slits in the adjacent rows (if the slit is located in the middle). In other words, the slits in the expandable section may have a so-called "bricklay" arrangement, or they may be arranged like bricks in a so-called "longitudinal lay pattern." Such an arrangement of struts defined by multiple slits and adjacent rows of multiple slits can enable the expandable section 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).

[0016] In some embodiments, the slits in the expandable section of the hypotube of the occlusion device may be arranged to allow the struts to provide a rotational force and / or to twist or rotate as the expandable section, or a portion thereof, expands. Such an arrangement may also allow the expanded portion of the expandable section to return to its unexpanded state after an appropriate constraining force is applied to the hypotube (e.g., when an external force constrains the hypotube within a tube, the tube diameter decreases, the rotating struts rotate back to a flat, unrotated position, etc.). In such an arrangement, the expandable section may have a smooth outer surface when in a constrained or unexpanded state that may facilitate its movement through the catheter. As the expandable section expands and its struts rotate, the struts may engage surrounding tissue (e.g., tissue of a vessel), thereby holding the expandable section in place relative to the surrounding tissue.

[0017] Manufacturing an occlusion device according to the present disclosure may include cutting slits into the wall of the hypotube at appropriate locations. The hypotube may be loaded onto a mandrel to form the hypotube into a desired shape. The desired shape of the hypotube, and therefore the desired shape of the occlusion device, may be solidified (e.g., by heating if the hypotube is formed from Nitinol or the like). A restraining force may then be applied to the hypotube or occlusion device to contract or shrink it. The restraining force may shrink the hypotube to a shape and dimensions that facilitate storage of the hypotube and subsequent insertion into the subject's body. In some embodiments, the occlusion device may be restrained within a loading device.

[0018] When it is desired to use the occlusion device, it may be introduced into the subject's body. For example, a catheter may be advanced to a desired location within the subject's body. The occlusion device may be introduced into a proximal end of the catheter and advanced through the lumen of the catheter to the desired location. When the occlusion device exits the distal tip of the catheter at the desired location, it may automatically assume its enlarged (widened) outer diameter and intended final shape, thus at least partially occlude the desired location in a desired manner. The conditions (e.g., temperature, etc.) of the target location may enable the occlusion device to self-expand and automatically assume its final shape, and / or may enable the occlusion device to retain its enlarged outer diameter and final shape as it continues to be exposed to one or more conditions at the target location.

[0019] Other aspects of the disclosed subject matter, as well as features and advantages of various aspects of the disclosed subject matter, will become apparent to those of ordinary skill in the art by consideration of the ensuing description, the accompanying figures, and the appended claims. [Brief description of the drawings]

[0020] [Figure 1A] 1 is an image of the vasculature prior to placement of an occlusion device, showing the effect of the occlusion device on the vasculature of a subject. [Figure 1B] 11 is an image of the vasculature after deployment of an occlusion device, showing the effect of the occlusion device on the vasculature of a subject. [Figure 2A] 1A-1C illustrate features of existing occlusion devices that include coils. [Figure 2B] FIG. 13 is another diagram illustrating features of an existing occlusion device that includes a coil. [Figure 3A] 1A-1C show an embodiment of a coiled occlusion device comprising a symmetrical helix. [Figure 3B] 1A-1C show an embodiment of a coiled occlusion device comprising an asymmetric helix. [Figure 3C] 1A-1C show an embodiment of a coiled occlusion device comprising a funnel. [Figure 3D] 1A-1C show an embodiment of a coiled occlusion device comprising a modified funnel. [Figure 3E] 1A-1C show an embodiment of a coiled occlusion device that comprises a somewhat spherical, or ball, shape. [Figure 4] FIG. 1 shows an occlusion device within a cavity or sac-type aneurysm. [Figure 5A] 1A-1C show an embodiment of an occlusion device having a body including an expandable section having an expandable and contractible outer diameter (OD). [Figure 5B] FIG. 13 illustrates another embodiment of an occlusion device having a body including an expandable section having an expandable and contractible outer diameter (OD). [Figure 5C] FIG. 13 illustrates another embodiment of an occlusion device having a body including an expandable section having an expandable and contractible outer diameter (OD). [Figure 5D] FIG. 13 illustrates another embodiment of an occlusion device having a body including an expandable section having an expandable and contractible outer diameter (OD). [Figure 6A-1] FIG. 1 is an end view of a conventional occlusion device in its final shape. [Figure 6A-2] FIG. 1 is an isometric view of a conventional occlusion device in its final shape. [Figure 6B-1] FIG. 1 is an end view of an embodiment of an occlusion device of the present disclosure, with the body in an unexpanded state while assuming its final shape. [Figure 6B-2] FIG. 1 is an isometric view of an embodiment of an occlusion device of the present disclosure in an unexpanded state while the body is assuming its final shape. [Figure 6C-1] FIG. 6B-1 is an end view of the embodiment of the occlusion device shown in FIG. 6B-1, with the body in an expanded state and assuming its final shape. [Figure 6C-2] FIG. 6B-3 is an isometric view of the embodiment of the occlusion device shown in FIG. 6B-2 with the body in an expanded state and assuming its final shape. [Figure 7B]6B-1 and 6B-2 are detailed end views of the embodiment of the occlusion device shown in FIGS. 6B-1 and 6B-2, with the body in the unexpanded state shown in FIGS. 6B-1 and 6B-2. [Figure 7C] FIG. 6C-1 and FIG. 6C-2 are detailed end views of the embodiment of the occlusion device shown in FIGS. 6C-1 and 6C-2, with the body in the expanded state shown in FIGS. 6C-1 and 6C-2. [Figure 8A] FIG. 6C-1, 6C-2, and 7C are isometric views of variations of the embodiment of the occlusion device shown in FIGS. 6C-1, 6C-2, and 7C, in which the body is in the expanded state shown in FIGS. 6C-1, 6C-2, and 7C, and at least one of its ends is tapered. [Figure 8B] 6C-1, 6C-2, and 7C are isometric views of other variations of the embodiment of the occlusion device shown in FIG. 6C-1, 6C-2, and 7C, in which the body of the occlusion device is in the expanded state shown in FIG. 6C-1, 6C-2, and 7C, and at least one end of each occlusion device is oriented along the longitudinal axis of the expanded occlusion device. [Figure 8C] 6C-1, 6C-2, and 7C are isometric views of other variations of the embodiment of the occlusion device shown in FIG. 6C-1, 6C-2, and 7C, in which the body of the occlusion device is in the expanded state shown in FIG. 6C-1, 6C-2, and 7C, and at least one end of each occlusion device is oriented along the longitudinal axis of the expanded occlusion device. [Figure 8D] 6C-1, 6C-2, and 7C are isometric views of other variations of the embodiment of the occlusion device shown in FIG. 6C-1, 6C-2, and 7C, in which the body of the occlusion device is in the expanded state shown in FIG. 6C-1, 6C-2, and 7C, and at least one end of each occlusion device is oriented along the longitudinal axis of the expanded occlusion device. [Figure 8E] 6C-1, 6C-2, and 7C are isometric views of other variations of the embodiment of the occlusion device shown in FIG. 6C-1, 6C-2, and 7C, in which the body of the occlusion device is in the expanded state shown in FIG. 6C-1, 6C-2, and 7C, and at least one end of each occlusion device is oriented along the longitudinal axis of the expanded occlusion device. [Figure 8F]FIG. 11 is a two-dimensional view of an embodiment of a cut pattern for forming an occlusion device having a somewhat spherical shape from a hypotube, such as that illustrated by FIGS. 9A-9E. [Figure 8G] FIG. 11 is another two-dimensional view of an embodiment of a cut pattern for forming an occlusion device from a hypotube having a somewhat spherical shape, such as that illustrated by FIGS. 9A-9E. [Figure 8H] FIG. 8C is a diagram of a variation of the cut pattern shown in FIGS. 8F and 8G. [Figure 8I] FIG. 8C is another view of a variation of the cut pattern shown in FIGS. 8F and 8G. [Figure 8J] FIG. 8C is another view of a variation of the cut pattern shown in FIGS. 8F and 8G. [Figure 9A] 1 is a side view of another embodiment of an occlusion device according to the present disclosure having a somewhat spherical shape. [Figure 9B] 1 is a cross-sectional view of another embodiment of an occlusion device in accordance with the present disclosure having a somewhat spherical shape. [Figure 9C] 1 is a perspective view of another embodiment of an occlusion device according to the present disclosure having a somewhat spherical shape. [Figure 9D] A figure showing a variation of the embodiment of the occlusion device shown in Figures 9A-9C, in which at least some of the cells formed when the body of the occlusion device expands are smaller than the cells formed when the body of the occlusion device shown in Figures 9A-9C expands. [Figure 9E] FIG. 9B is another view showing a variation of the embodiment of the occlusion device shown in FIGS. 9A-9C, in which at least some of the cells formed when the body of the occlusion device expands are smaller than the cells formed when the body of the occlusion device shown in FIGS. 9A-9C is expanded. [Figure 9F] FIG. 11 is a two-dimensional view of an embodiment of a cut pattern for forming an occlusion device having a somewhat spherical shape from a hypotube, such as that illustrated by FIGS. 9A-9E. [Figure 9G]FIG. 11 is another two-dimensional view of an embodiment of a cut pattern for forming an occlusion device from a hypotube having a somewhat spherical shape, such as that illustrated by FIGS. 9A-9E. [Figure 10] 9A-9C, in which the struts of the expandable section of the body of the occlusion device have serrated edges. [Figure 11] 13A-13C illustrate alternative final shapes of an occlusion device according to the present disclosure. [Figure 12] 1A-1C illustrate embodiments of occlusion devices having expandable coatings and / or filling materials. [Figure 13] 1A-1C illustrate embodiments of occlusive devices that include a fabric or film covering. [Figure 14] 1A-1C illustrate an embodiment of a method for deploying an occlusion device at a target location within a subject. [Figure 15A] FIG. 1 illustrates an embodiment of a delivery system and its use. [Figure 15B] FIG. 13 is another diagram illustrating an embodiment of a delivery system and its use. [Figure 15C] FIG. 13 is another diagram illustrating an embodiment of a delivery system and its use. [Figure 15D] FIG. 13 is another diagram illustrating an embodiment of a delivery system and its use. [Figure 15E] 15A-15D depict control wire variations of the delivery system embodiment shown in FIG. [Figure 15F] FIG. 18 is another diagram illustrating a variation of the control wire of the delivery system embodiment shown in FIGS. 15A-15D. [Figure 15G] FIG. 18 is another diagram illustrating a variation of the control wire of the delivery system embodiment shown in FIGS. 15A-15D. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] 5A-5D, an embodiment of an occlusion device 10 is shown. The occlusion device 10 is shown in an unexpanded or constrained state that facilitates insertion into and / or removal from a subject's body. As shown in FIG. 5A, the occlusion device 10 may be elongated while in the constrained state.

[0022] The occlusion device 10 comprises a body 12. The body 12 may be formed from any of a variety of suitable materials or combinations of suitable materials. In some embodiments, the entire body 12 may be defined from or comprise a hypotube, which may be formed from a substantially rigid material, such as a metal. Examples of suitable metals include, but are not limited to, memory alloys (e.g., Nitinol, etc.), cobalt chromium (CoCr), nickel chromium (NiCr or Nichrome) alloys (including, but not limited to, NiCr steel), stainless steel (e.g., 316L stainless steel, 316 stainless steel, etc.), and the like. Alternatively, the body 12 may be formed from a polymer. A suitable polymer may have a sufficient hardness (e.g., at least 35 Shore D, 35 Shore D to 55 Shore D, 35 Shore D to 72 Shore D, etc.). Examples of suitable polymers include, but are not limited to, polyetheretherketone (PEEK), polyimide, nylon, polyether block amide (PEBA, such as that trademarked under PEBAX®), and extrusion molded plastics (provided they have a wall thickness that does not exceed the width of the strut 36, as described below).

[0023] The expandable section 30 of the body 12 of the occlusion device 10 may be capable of expanding outwardly (e.g., radially outwardly, etc.) from the unexpanded state shown in FIG. 5A to an expanded state and final shape. For example, in embodiments in which the body 12 is formed from a shape memory material, such as a shape memory alloy, the expandable section 30 may expand to its final shape upon exposure to appropriate conditions (e.g., body temperature, etc.). As another example, in embodiments in which the body 12 is formed from stainless steel or a polymer, the expandable section 30 may expand to its final shape upon removal of a restraining force from the body 12.

[0024] As shown in Figures 5B-5D, the expandable section 30 may 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 some embodiments, each slit 32 may extend completely through the wall of the body 12 from its outer surface to its inner surface. In other embodiments, each slit 32 may extend only partially through the wall of the body 12 (e.g., 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 may depend, at least in part, on the material from which the body 12 is formed.

[0025] The slits 32 may have the same length as one another (except for some slits 32 located at the ends of the expandable section 30). Adjacent slits 32 in a series 32a, 32b, 32c, etc. are separated by solid, uncut regions of the body 12. These solid regions may be referred to as joints 38 or junctions.

[0026] Each 34a series, 34b series, 34c series, etc. may be defined by a linearly aligned slit 32. The slit 32 and each 34a series, 34b series, 34c series, etc. may extend longitudinally along the body 12, with each 34a series, 34b series, 34c series, etc. positioned along a generatrix of the expandable section 30 (i.e., a line extending from one end of the expandable section 30 to the other end of the expandable section 30, parallel to the longitudinal axis of the expandable section 30). Such an orientation may be referred to as a "linear" orientation. Alternatively, each 34a series, 34b series, 34c series, etc. may be oriented helically around the body 12.

[0027] Each 34b series, 34c series, 34d series, etc. slit 32 may be offset with respect to each adjacent 34a series, 34b series, 34c series, 34d series, 34e series, etc. slit 32. Each slit 32 within a 34a series, 34b series, 34c series, etc. may overlap approximately half of one circumferentially adjacent slit 32 (if the slit 32 is located at or near an end of the expandable section 30) or two circumferentially adjacent slits 32 (if the slit 32 is located midway along the length of the expandable section 30) of each adjacent 34a series, 34b series, 34c series, etc. Staggering the slits 32 around the circumference of the expandable section 30 of the body 12 may result in the expandable section 30 having a so-called "bricklaying" appearance, with solid portions of the body 12 between the slits 32 arranged in a so-called "longitudinal laying pattern."

[0028] Circumferentially adjacent series 34a, 34b, 34c, etc. of slits 32 may be equally spaced around the circumference of body 12. Expandable section 30 may include an even number of series 34a, 34b, 34c, etc. of slits 32. In embodiments in which an even number of circumferentially adjacent series 34a, 34b, 34c, etc. of slits 32 are equally spaced around the circumference of body 12, each slit 32 of expandable section 30 may be staggered with respect to its circumferentially adjacent slits 32. Alternatively, the distance between slits 32 in one circumferentially adjacent series 34a may be different from the distance between slits 32 in another circumferentially adjacent series 34c. Thus, the number of slits 32 in one circumferentially adjacent series 34a may be different from the number of slits 32 in another circumferentially adjacent series 34c.

[0029] The solid portions of the body 12 located between each adjacent pair of slits 32, such as series 34a and 34b, series 34b and 34c, series 34c and 34d, comprise the struts 36 of the expandable section 30. More specifically, each strut 36 may comprise a solid portion of the body 12 between adjacent series 34a and 34b, series 34b and 34c, series 34c and 34d, etc. of the slits 32. Stated differently, each slit 32 comprises a gap between circumferentially adjacent pairs of struts 36. In embodiments in which series 34a, series 34b, series 34c, etc. 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 in which series 34a, series 34b, series 34c, etc. are oriented helically around the body 12, the struts 36 may also be oriented helically or as a spiral around the body 12.

[0030] Staggering the slits 32 may allow the expandable section 30 to expand. In some embodiments, the struts 36 may rotate as the expandable section 30 expands. Such rotation may occur, for example, in embodiments where each ring of circumferentially aligned struts 36 about the expandable section 30 includes an even number of struts 36. As the slits rotate, they may protrude outward (e.g., radially) from the circumference of the expandable section 30, thereby securing the occlusion device 10 in place.

[0031] In other embodiments, the slits 32 are not staggered and the struts 36 do not rotate when the expandable section 30 is expanded. In such embodiments, the resulting occlusion device 10 may still expand to create multiple points of contact with the wall of the vessel or cavity in which it resides to secure the occlusion device 10 in place within the vessel or cavity.

[0032] The expandability provided by the slits 32 and struts 36 of the expandable section 30 of the body 12 of the occlusion device 10 allows the outer diameter (OD) of the body 12 to expand to provide a first degree of expansion. Additionally, as the OD of the body 12 expands, the body 12 may assume a predetermined tertiary shape or a desired occlusion or final shape to provide a second degree of expansion.

[0033] 6A-6C contrast occlusion provided by a single degree of expansion, as occurs when a conventional occlusion device 110 assumes its final shape (FIGS. 6A-1 and 6A-2), with occlusion provided by two or more degrees of expansion, as occurs when an occlusion device 10 according to the present disclosure expands and assumes its final shape (FIGS. 6B-1 through 6C-2). FIG. 6A-1 provides an end view of an embodiment of a conventional occlusion device 10' (e.g., 035 5 mm x 2 cm coil) including the final shape of the conventional occlusion device 110 as seen in FIG. 6A-2, as well as a coiled wire 112 that has been coiled into a coil. Such a conventional coiled occlusion device 110 reduces the area across the lumen (e.g., vessel, etc.) in which it is placed (e.g., by about 59%). Notably, the OD of the coiled wire 112 does not expand.

[0034] 6B-1 and 7B provide end views of an embodiment of the presently disclosed occlusion device 10 in which its body 12 is in an unexpanded state but in its final coiled shape as seen in FIG. 6B-2 (e.g., a 0.035 5 mm x 2 cm coil). The original dimensions of the body 12 of the occlusion device 10 (e.g., its OD) may be the same as or substantially the same as the corresponding dimensions of the coiled wire 112 of the conventional occlusion device 110 (e.g., an OD of 0.035 inches or 0.89 mm).

[0035] While the OD of the coiled wire 112 of a conventional occlusion device 110 does not expand, as FIGS. 6C-1, 6C-2, and 7C show, the OD of the body 12 of the occlusion device 10 of the present disclosure can expand (e.g., twice the OD of 0.070 inches or 1.8 mm). As FIG. 7C shows, the body 12 expands as the slits 32 therein open around the circumference of the body 12. As shown in FIG. 6C-2, as the body 12 expands, the volume it occupies increases, allowing the occlusion device 10 to provide improved occlusion when it assumes its final shape (e.g., the occlusion device 10 can reduce the area across the lumen in which it is placed by at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 92%).

[0036] 8A, when the body 12 of the occlusion device 10 is in its expanded state, the OD of one or both ends 16, 17 of the body 12 may be the same as the OD along the remainder (central portion) of the body 12, and / or one or both ends 16, 17 may have a reduced OD (e.g., it may be tapered at that end, adjacent to that end, etc.). In the illustrated embodiment, the end 16 has an OD that is the same as the OD of the majority of the body 12 (e.g., an OD of 0.070 inches or 1.8 mm, etc.), while the end 17 tapers to a smaller OD (e.g., an OD of 0.035 inches or 0.89 mm, etc.).

[0037] 6A-8A show coiled occlusion device 10 with ends 16 and 17 oriented along the coil, the ends 16 and 17 of such occlusion device 10 may be oriented in any of a variety of suitable directions. As an example, FIG. 8B shows one or both ends 16 and 17 of body 12 oriented along the longitudinal axis A of coiled expanded body 12. L 1 shows a variation of the occlusion device 10 positioned along the occlusion end 16. Such an orientation of one of the ends 16, 17 (such as the forward or distal end 16) can facilitate smooth deployment of the occlusion device 10.

[0038] The ends 16 and 17 of the variation of the occlusion device 10 shown in Figures 8A and 8B have substantially the same OD as the remainder of the unexpanded body 12, while the ends 16 and 17 of the variation of the occlusion device 10 shown in Figures 8C and 8D taper to an OD that is smaller than the OD of the unexpanded body 12. The ends 16, 17 tapered in this manner may be referred to as "reduced ends."

[0039] In addition to tapering or being foreshortened to an OD smaller than the OD of the unexpanded body 12, one or both ends 16, 17 of the occlusion device 10 may also be flared outwardly, as shown in FIG. 8E. The flared ends 16, 17 may be expanded to the same OD as the OD of the expanded body 12, or the expanded OD of the flared ends 16, 17 may be smaller or larger than the OD of the expanded body of the occlusion device 10. The flared ends 16, 17 may be useful for blocking blood flow, promoting clotting, anchoring the occlusion device 10 (e.g., the flared ends 16, 17 may expand into the intima when the occlusion device 10 is moved in the direction in which the flared ends 16, 17 face), promoting endothelial tissue growth, or any of a variety of other purposes.

[0040] 8D and 8E show that the body 12 of the coiled occlusion device 10 can be relatively short (e.g., it can have fewer than four turns, but at least one full turn, etc.) as compared to the longer body 12 of the occlusion device 10 shown in FIGS. 8A-8C (which is shown having four turns, but can have more than four turns).

[0041] 8F and 8G provide two-dimensional views of an embodiment of a cut pattern for forming an occlusion device 10 from a hypotube 11 having a coil shape as shown by FIG. 8B. The entire circumference of the hypotube 11 is shown in FIGS. 8F and 8G as if the hypotube had been separated, spread and flattened. The cut patterns shown in FIGS. 8F and 8G may be used to define struts 36 having widths of about 0.001 inches (about 0.025 mm) to about 0.009 inches (about 0.23 mm) and slits 32 between adjacent struts 36 having widths of about 0.001 inches (about 0.025 mm) to about 0.009 inches (about 0.23 mm) and lengths of about 0.005 inches (about 0.13 mm) to about 0.035 inches (about 0.89 mm). In some embodiments, the slits 32 may be about 0.125 inches (about 3.2 mm) long. In embodiments in which the resulting occlusion device 10 has a length of about 1.633 inches (about 41.5 mm) and an outer diameter of about 0.035 inches (about 0.89 mm), or a length of about 1.905 inches (about 48.4 mm) and an outer diameter of about 0.038 inches (about 1 mm), the occlusion device may include as few as about 50 slits 32, or as many as about 500 or more slits 32.

[0042] Although the slits 32 shown in Figures 8F and 8G are linear or straight, the slits 32, and therefore the struts 36, may have any of a variety of different shapes. As non-limiting examples, Figure 8H shows a cut pattern having linear slits 32l and bowtie shaped slits 32b, Figure 8I shows a cut pattern having linear slits 32l and elliptical slits 32o, and Figure 8J shows a cut pattern having linear slits 32l and diamond shaped slits 32d. The shape of the slits 32 may impart different properties to the occlusion device 10. For example, the shape of the slits 32 and struts 36 may affect the flexibility of the struts 36 (e.g., bowtie shaped slits 32b may make the resulting struts 36b more flexible, etc.), the smoothness of the occlusion device 10, the expandability of the occlusion device 10, etc.

[0043] Such an occlusion device 10, having a final shape of a symmetrical helix with dimensions of about 5 mm by 2 cm, and an OD of about 0.035 inches (about 0.89 mm), may have 50% less metal mass than a conventional occlusion device having the same final shape and dimensions. For example, a standard 035 5 mm by 2 cm coil with 0.005 inch (0.13 mm) wire has a mass of 2.387 mm. 3 035 5 mm x 2 cm coil occlusion device 10 according to the present disclosure formed from hypotube having a wall thickness of 0.0018 inches (0.046 mm) while having a metal volume of 1.015 mm / cm. 3 / cm metal volume. Thus, the presently disclosed occlusive device 10' may reduce metal volume and mass by about 50% to about 80% relative to the mass of a similarly sized conventional occlusive device.

[0044] By reducing the metallic mass, artifacts in a computed axial tomography (CT) scan of the occlusion device 10 after it is implanted in a subject's body will be reduced. Certain subject patients with existing conventional occlusion devices cannot be effectively imaged by CT for future follow-up due to the size or location of the CT artifacts produced by such conventional occlusion devices. As a result, follow-up may require an invasive angiogram. By reducing the CT artifacts, subjects who receive a metallic occlusion device 10 according to the present disclosure may be able to undergo CT scans for future follow-up.

[0045] When expanded to its final shape, the occlusion device 10 may assume the coil shape illustrated by Figures 6A-8E or any of a variety of different predetermined shapes. Such final shapes include, but are not limited to, the shapes illustrated in Figures 3A-3E. Figure 11 illustrates an embodiment of an occlusion device having a diamond or double funnel shape.

[0046] 9A-9C provide illustrations of an embodiment of an occlusion device 10' comprising a plug having a somewhat spherical (e.g., spherical, ovoid, etc.) final shape when placed in a fully expanded state (i.e., with the body 12' of the occlusion device 10' expanded and allowed to assume its final shape). As shown, when the body 12' is in its expanded state, the struts 36' may rotate outward (e.g., up to about 90°, etc.), thereby allowing the occlusion device 10' to engage the tissue (e.g., the intima of a blood vessel, etc.) against which it is positioned and expanded. Without being limiting, the final shape may have a diameter of up to about 5 mm. FIG. 10 shows a variation of an occlusion device 10'' in which the slits 32'' define struts 36'' having serrated edges.

[0047] A particular embodiment of an occlusion device 10' according to the present disclosure may have an unexpanded OD of about 0.035 inches, six to eight struts 36' having a width of about 0.009 inches around its circumference, spacing of about 0.010 inches separating adjacent pairs of struts 36' from each other, and slits 32' having a length of about 0.035 inches. When the body 12' of such an occlusion device 10' expands, the struts 36' may rotate and the slits 32' may open to define cells 33' between adjacent struts 36'. Such an occlusion device 10' may expand, for example, from an OD of about 0.035 inches to an OD of about 0.105 inches or more.

[0048] A variation of such an occlusion device 10' is shown in Figure 9D, which includes narrower struts 36' and narrower slits 32'. When the body 12' of the occlusion device 10' is expanded, the dimensions of the struts 36' and slits 32' may limit the distance adjacent struts 36' may be separated from one another and therefore the size of the cells 33' that form during expansion. The struts 36' may have a width of about 0.001 inch (about 0.025 mm) to about 0.009 inch (about 0.23 mm) and the slits 32' may have a width of about 0.001 inch (about 0.025 mm) to about 0.009 inch (about 0.23 mm) and a length of about 0.005 inch (about 0.13 mm) to about 0.030 inch (about 0.76 mm).

[0049] FIG. 9E shows another variation of such an occlusion device 10' including struts 36s' and slits 32s' that define smaller cells 33s' on one side 12s' of the body 12', and struts 36l' and slits 32l' that define larger cells 33l' on another side 12l' of the body 12'.

[0050] As shown in Figures 9A-9C and 9E, one or both ends 16', 17' of the body 12' of the expanded occlusion device 10' may protrude or flare out somewhat. Alternatively, as shown in Figure 9D, one or both ends 16', 17' of the expanded occlusion device 10' may be flush or substantially flush with the remainder of the body 12' of the expanded occlusion device 10'. As yet another alternative, and also shown in Figures 9D and 9E, one or both ends 16', 17' of the expanded occlusion device 10' may extend into the body 12' of the expanded occlusion device 10', or one or both ends 16' and 17' may be indented within the body 12'.

[0051] Figures 9F and 9G provide two-dimensional views of an embodiment of a cut pattern for forming an occlusion device 10' from a hypotube 11' having a somewhat spherical shape, such as that shown by Figures 9A-9E. The entire circumference of the hypotube 11' is shown in Figures 9F and 9G as if the hypotube had been separated, spread and flattened. Although the slits 32' shown in Figures 9F and 9G are linear or straight, the slits 32', and therefore the struts 36', may have any of a variety of different shapes that may impart different properties (e.g., flexibility, smoothness, expandability, etc.) to the occlusion device 10' and / or features thereof, as described with reference to Figures 8H-8J.

[0052] As some non-limiting examples, a somewhat spherical occlusion device 10' for occluding a vessel having an inner diameter of about 3 mm to about 5 mm may have a length of about 6 mm to about 8 mm and an expanded outer diameter of about 6 mm. Such an occlusion device 10' may have an unexpanded outer diameter of about 0.020 inches (about 0.5 mm) and may include as few as 8 struts 36' and as many as 20 struts 36' (e.g., 10 struts 36', etc.) around its circumference. A somewhat spherical occlusion device 10' for occluding a vessel having an inner diameter of about 5 mm to about 7 mm may have a length of about 8 mm to about 10 mm and an expanded outer diameter of about 8 mm. Such an occlusion device 10' may have an unexpanded outer diameter of about 0.035 inches (about 0.89 mm) and may 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.) around its circumference. A somewhat spherical occlusion device 10' for occluding a vessel having an inner diameter of about 7 mm to about 10 mm may have a length of about 12 mm to about 14 mm and an expanded outer diameter of about 12 mm. Such an occlusion device 10' may have an unexpanded outer diameter of about 0.035 inches (about 0.89 mm) and may include as few as 20 struts 36' and as many as 80 struts 36' around its circumference.

[0053] In some embodiments, an occlusion device 10, 10', 10", 10''', 10'''', etc., according to the present disclosure (hereinafter referred to as occlusion device 10 for simplicity) may include a coating (e.g., an expandable coating, a resiliently expandable / compressible coating, etc.) and / or a filler material (e.g., an expandable coating, a resiliently expandable / compressible filler material). The coating and / or filler material may also provide additional occlusion. The coating may extend on an exterior surface of the body 12, 12', 12", 12''', 12'''', etc., of the occlusion device 10 (hereinafter referred to as body 12 for simplicity). The filler material may be trapped in the lumen of the hypotube that defines the body 12 of the occlusion device 10. The filler material may absorb blood, thereby enhancing the ability of the occlusion device 10 to stop or occlude the flow of blood and blood-borne substances through an occluded vessel. In some embodiments, the coating and / or filler material may be bonded to the body 12.

[0054] As one example, the coating and / or filler material may include an expandable hydrogel that may swell to improve loading and packing density after the occlusion device 10 is placed. As another example, illustrated by FIG. 12, the occlusion device 10''' may be provided with an expandable polymer foam or mesh 40 that may 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"-nitrilotriethanol (TEA), 1,6-diisocyanatohexane (HDI), trimethylhexamethylene diisocyanate (mixture of 2,2,4- and 2,4,4-) (TMHDI), etc.). In another example, the occlusion device 10 may include a tubular member 32 (FIGS. 5B-5D) that is disposed within the lumen of the body 12 and extends through the slits 32. Flexible filaments or fibers may be provided that may extend through and / or be provided on the exterior surface of body 12. As yet another example illustrated by FIG. 13, a fabric (e.g., PTFE, etc.) or film 50 (e.g., a polymeric film, etc.) may cover at least a portion of body 12'''' of occlusion device 10'''' (e.g., its exterior and / or interior surface, etc.) in a manner that prevents fluid from flowing through open slits 32'''' in body 12'''' (FIGS. 5B-5D). Other embodiments of filler materials include, but are not limited to, other polymers, calcium alginate, starch, and other solid or semi-solid materials.

[0055] The filler material may be introduced into the occlusion device during manufacture of the occlusion device 10. In embodiments in which the occlusion device 10 includes tapered or reduced ends 16' and 17' (see, e.g., FIGS. 8C, 8D, and 8E) and / or smaller cells 33' (see, e.g., FIG. 9D), the ends 16', 17' and / or smaller cells 33' may enable the occlusion device 10' to receive and at least temporarily retain the filler material.

[0056] In addition to, or as an alternative to, enhancing the ability of occlusion device 10 to occlude, the coating and / or filler material may impart further properties to occlusion device 10. For example, the coating and / or filler material may absorb fluids from the subject's body, thereby facilitating embolization.

[0057] In another example, the filler may provide radiopacity to the occlusion device 10. Such filler may 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 migrating out of the body 12 when the body 12 is in an expanded state. Such filler may include cotton, nylon, fiber, filament, and / or another suitable material. The filler may be absorbable. In some embodiments, the filler may be made of a radiopaque material (e.g., tungsten, barium, iodine, bismuth trioxide (bismuth(III) oxide and / or Bi2O3), etc.) and / or another material that facilitates x-ray visualization.

[0058] The filler material may carry (e.g., absorb, etc.) a substance to be delivered to a target site within the subject's body. Examples of substances that may be carried by the filler material include, but are not limited to, contrast agents, drugs, therapeutic agents (e.g., radioactive materials for radiation therapy), etc. that may be applied to the filler during manufacturing or at tableside by a clinician during a pre-, during, or post-deployment procedure.

[0059] A clinician may inject a substance into the shipping and storage tube containing the occlusion device 10 prior to loading the occlusion device 10 into a catheter for delivery into the subject's body. The filler material within the occlusion device 10 may absorb or otherwise carry the substance. Alternatively, such a substance may be applied to and absorbed by the filler material during manufacture of the occlusion device 10.

[0060] In embodiments in which the substance includes a contrast agent, the contrast agent is radiopaque under fluoroscopic x-rays to guide placement of the occlusion device 10 as it is pushed through the catheter to the target location, as well as while the occlusion device 10 is deployed at the target location. After deployment, the contrast agent may dissipate, elute, and / or wash out of the occlusion device 10. This allows the occlusion device 10 to be seen during placement, but after placement, x-ray visualization is attenuated, which may be advantageous for viewing adjacent anatomical structures and pathology. In embodiments in which the substance includes a drug, therapeutic agent (e.g., oncolytic, radioisotope, such as yttrium 90 (Y90), during a radioembolization procedure), nutrient, diagnostic agent, marker, targeting compound, etc., the substance may be eluted after the occlusion device 10 is placed at a target location within the subject's body. The rate at which the substance elutes from the filler material, and thus from the occlusion device 10, over time may depend, at least in part, on any of a variety of factors that should be apparent to one of ordinary skill in the relevant art, including, but not limited to, the composition, density, and / or amount of the filler material. Elution may occur over a duration of minutes, hours, days, or even longer periods of time.

[0061] Optionally, the clinician may inject a substance into the catheter that delivers the occlusion device 10 before or while the occlusion device is deployed (with or without a filler material) and the occlusion device is advanced along the catheter. This allows the clinician to inject a substance into the catheter while the constrained occlusion device 10 is being pushed through the catheter, but may allow the substance to dissipate after the occlusion device 10 is positioned at its target location.

[0062] Alternatively, the substance may be introduced into the occlusion device 10 or its filling material through a catheter after the occlusion device 10 has been deployed.

[0063] The substance may also be applied directly to the body 12 of the occlusion device 10 (e.g., one or more struts 36 thereof, etc.). The substance may be bonded, painted, adhered, or otherwise applied to the body 12 of the occlusion device 10. As another option, a band carrying the substance (e.g., a radiopaque band, etc.) may be crimped onto one or more struts 36 and / or one or both ends 16, 17 of the body 12.

[0064] In some embodiments, the occlusion 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 occlusion device 10. In some embodiments, the sensor may include a radio frequency identification sensor or chip.

[0065] The method of manufacturing the occlusion device 10 may use a hypotube (e.g., a nitinol hypotube having a 0.035 inch (0.89 mm) OD and about 0.030 inch (about 0.76 mm) ID, etc.). Slits 32 (FIGS. 5B-5D) may 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 may be cut from end to end of the hypotube, so that the outer diameter of the hypotube expands consistently along the entire length of the hypotube. Alternatively, the slits 32 may not extend to locations of the hypotube that are not intended to expand or remain constrained when the occlusion device 10 is deployed (e.g., one or both ends thereof, one or more intermediate locations, etc.). The restrained locations may be useful for a variety of purposes, such as retaining material inside the occlusion device 10, providing a connection point for a deployment mechanism to facilitate deployment and / or positioning of the occlusion device 10, or connecting the occlusion device 10 to another occlusion device.

[0066] Cutting slits 32 into the hypotube may result in struts 36 with blunt edges or with sharp edges. Additionally, cutting the slits may include the definition of features along the edges of the struts 36, such as teeth, serrations, edge roughness, etc. Such features may allow the resulting occlusion device 10 to be anchored in place within a target location within a subject's body, thereby promoting an endothelial and / or thrombotic response, and / or otherwise preventing migration of the occlusion device 10 after it is positioned within the target location.

[0067] The edges of the struts 36 defined by the slits 32 may be modified after the slits 32 are cut. In some embodiments, the edges may be polished. In other embodiments, the edges may be sharpened.

[0068] Other features may also be cut into the hypotube. For example, slots, holes, channels, 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 engage with a deployment mechanism (e.g., a removable pusher, etc.). In a specific embodiment, one or more round (e.g., 0.003 inch or 0.076 mm diameter, etc.) female recesses or channels may be formed in the end 16 of the hypotube. These female recesses or channels may receive extendable / retractable round (e.g., 0.003 inch (0.076 mm) or smaller diameter) male features of the deployment mechanism. The connection may be secure enough for a user to push and pull the occlusion device 10 through a delivery device 200 (FIG. 14), such as a catheter, sheath, cannula, needle, etc.

[0069] The slit hypotube may then be loaded onto a mandrel (e.g., a hard steel mandrel) of the desired shape (e.g., tapered straight, spiral, funnel, etc.). As the slit hypotube is loaded onto the mandrel, it may expand to increase its ID and OD (e.g., to about 0.075 inches or about 1.9 mm). The expansion of the slit hypotube may cause the slits 32 in the hypotube to open, exposing the struts 36 (FIGS. 5B-5D) of the hypotube. The expanded, slit hypotube may then be heated to a temperature (e.g., about 400° C. to about 600° C., etc.) sufficient for a sufficient duration (e.g., up to 1 hour, etc.) to solidify the nitinol into its expanded state. The hypotube may then be cooled. The hypotube may remain on the mandrel or may be removed from the mandrel. The cooled hypotube may then be constrained back to its original OD by physically squeezing the OD and / or by forcing the expanded hypotube into a funnel-shaped hypotube fixture that narrows the hypotube from about 0.080 inch (about 2.0 mm) ID to about 0.035 inch (about 0.89 mm) or less. The constrained hypotube may then be loaded (e.g., pushed, etc.) into a shipping and storage tube to keep the hypotube constrained until deployment. This manufacturing method applies to hypotubes of all sizes, 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 other ODs, IDs, and lengths.

[0070] 14 , a method of using occlusion device 10 includes advancing a distal tip 202 of a delivery device 200, such as a catheter, sheath, hypotube, cannula, needle, or the like, as shown, to a target location T within a subject's body. Occlusion device 10 may be transferred from a loading device (not shown) into a proximal end 204 of delivery device 200. Occlusion device 10 may be advanced along the length of delivery device 200 until it reaches distal tip 202. As occlusion device 10 emerges from distal tip 202, or is deployed, occlusion device 10 may at least partially expand and be positioned against a surface of target location T (e.g., against the intima of a vessel, etc.). Deployment may be accomplished by pushing constrained occlusion device 10 distally from distal tip 202 (e.g., with deployment mechanism 210, etc.) and / or pulling delivery device 200 proximally while maintaining a position of occlusion device 10 within the subject's body (e.g., at target location T, etc.).

[0071] After being fully deployed from the distal tip 202, the occlusion device 10 may assume its final shape.

[0072] After the occlusion device 10 exits the delivery device 200, the deployment mechanism 210 may remain connected to the occlusion device 10. This may allow the clinician to confirm accuracy of placement. Optionally, the clinician may push, pull, drag, or otherwise move the at least partially expanded occlusion device 10 (e.g., with the deployment mechanism 210, etc.) to position the occlusion device 10 at the target location T. Such movement may also ablate, agitate, or mechanically stimulate the intima at the target location T to elicit an inflammatory response (with or without injection of a sclerosing agent), thereby facilitating temporary or permanent immobilization, and thus temporary or permanent embolization, of the occlusion device 10 at the target location T.

[0073] If the placement accuracy is acceptable, the deployment mechanism 210 may be decoupled from the occlusion device 10 (e.g., by retracting the extendable / retractable round male feature of the deployment mechanism 210 to disengage the deployment mechanism 210 from the occlusion device 10).

[0074] 15A-15H illustrate an embodiment of a delivery system 2 that may be used to deliver an occlusion device 10 to a target location T (FIG. 14) within a subject's body. As shown in FIG. 15A, the delivery system 2 includes a delivery device 200 (e.g., a catheter, sheath, hypotube, cannula, needle, etc.), a control wire 210, and optionally a slider 220 that controls distal and / or proximal movement of the control wire 210 through a lumen of the delivery device 200. In some embodiments, the delivery device 200 may comprise a hypotube formed from any suitable material (e.g., stainless steel, nitinol, 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 from any suitable material (e.g., stainless steel, nitinol, polyester, PEEK, etc.) and may have 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 comprise a hand-held slider that may be held in the clinician's hand, which may include a switch 222 that may be moved by the thumb or finger of the clinician's hand on the hand holding the slider 220 to control the movement of the control wire 210 through the delivery device 200.

[0075] The control wire 210 may include a distal end 212 that carries the occlusion device 10 until it is delivered to the target location T. As shown in FIG. 15A , while the occlusion device 10 resides within the lumen of the delivery device 200 and the distal end 212 of the control wire 210 resides inside the occlusion device, the delivery device 200 constrains the occlusion device 10 and the occlusion device 10 constrains the distal end 212 of the control wire 210. Thus, the distal end 212 of the control wire 210 abuts the inner surface of the occlusion device 10, thereby engaging the occlusion device 10. The distal end 212 of the control wire 210 may remain relatively linear or curved while the distal end 212 is constrained inside the occlusion device 10. Additionally, the occlusion device 10 is constrained within the lumen of the delivery device 200. As shown in FIG. 15B, the distal end 212 of the control wire 210 may expand (e.g., to an outer diameter up to twice its original outer diameter) when the distal end 212 of the control wire 210 and the occlusion device 10 carried by the distal end 212 are advanced beyond the distal tip 202 of the delivery device 200.

[0076] As shown in FIG. 15B, after the occlusion device 10 and the distal end 212 of the control wire 210 are advanced beyond the distal tip 202 of the delivery device 10, the distal end 212 of the control wire 210 may expand along with and within the occlusion device 10 that it carries such that the control wire 210 remains engaged with the occlusion device and thus may be used to reposition the occlusion device 10 after it exits the delivery device 200.

[0077] The configuration of the distal end 212 of the control wire 210 may allow the distal end to be reconstrained more easily than the occlusion device 10 may be reconstrained. Thus, after the occlusion device 10 is properly positioned at its target location T (FIG. 14) as shown in FIGS. 15C and 15D, the distal end 212 of the control wire 210 and the occlusion device 10 may be pulled proximally relative to the distal tip 202 of the delivery device 200, and the distal end 212 of the control wire 210 may be withdrawn from the occlusion device 10 and into the distal tip 202 of the delivery device 200. The delivery device 200 and the control wire 210 may then be withdrawn from within the subject's body.

[0078] 15A-15D show that the distal end 212 of the control wire 210 has a coil shape when the distal end 212 is unconstrained and therefore expanded, however, distal ends 212 having different expanded sizes and different shapes are also within the scope of this disclosure. Figures 15E-15G show several different configurations of the expanded distal end 212.

[0079] Without limitation, an occlusion device 10 according to the present disclosure may be used to facilitate luminal filling, reduce flow, improve thrombosis, improve hyperplasia, reduce radiodensity, or otherwise promote occlusion. Such an occlusion device 10 may be used in connection with a variety of conditions, including, without limitation, arteriovenous malformations, hemorrhage, perforation, aneurysms, uterine fibroids, varicose veins, hemostasis, distal embolism, and other conditions. The occlusion device 10 may be used to treat COVID-19 patients with elevated D-dimer levels (a fibrin protein antigen fraction found in blood tests indicating coagulation disorders) and life-threatening blood clots in the heart, lungs, brain, and peripheral vessels. Hemorrhage is a complication of blood clots, and hemorrhage may be treated by an embolic device. See, for example, https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC7203058 / https: / / www.medicalnewstoday.com / articles / covid-19-ive-never-seen-such-sticky-blood-says-thrombosis-expert https: / / www.sciencedaily.com / releases / 2020 / 06 / 200630125129.htm https: / / pubmed.ncbi.nlm.nih.gov / 32339221 / https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC7146714 / https: / / pubmed.ncbi.nlm.nih.gov / 32316063 / https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC7225095 / https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC7229939 / https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC7255402 / https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC7177070 / The disclosures of these documents are incorporated herein.

[0080] Although the foregoing disclosure provides many details, these should not be construed as limiting the scope of any of the appended claims, but merely as providing illustrations of some embodiments of the elements and features of the disclosed subject matter. Other embodiments of the disclosed subject matter, and its elements and features, may be devised without departing from the spirit or scope of any of the claims. Features from different embodiments may be used in combination. Thus, the scope of each claim is limited only by its plain language and its legal equivalents.

Claims

1. In the occlusion device, 1. An occlusion device comprising a hypotube having a plurality of struts that rotate and move away from one another when the hypotube is expanded to an enlarged outer diameter and a final shape when deployed to a target location within a subject's body, wherein the enlarged outer diameter and the final shape can at least partially occlude a passageway through a portion of the subject's body.

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

3. 2. The occlusion device of claim 1, wherein when the hypotube is in the final shape, the end of the hypotube tapers from an expanded outer diameter of the hypotube to a distal outer diameter that is smaller than the expanded outer diameter.

4. 2. The occlusion device of claim 1, wherein when the hypotube is in its final shape, a portion of the hypotube adjacent its end tapers from an expanded outer diameter of the hypotube to a reduced outer diameter that is smaller than the expanded outer diameter, and the end of the hypotube includes a flare having a terminal outer diameter that exceeds the reduced outer diameter.

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

6. The occlusion device of claim 1 , further comprising a filler material within the hypotube.

7. The occlusion device of claim 6 , wherein the filler material comprises an absorbent material.

8. The occlusion device of claim 7 , wherein the filler material further comprises another substance.

9. The occlusive device of claim 8 , wherein the additional substance elutes from the absorbent material over time when present in the subject's body.

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

11. 2. The occlusion device of claim 1, wherein a first portion of the hypotube includes a plurality of first struts that move apart from one another a first distance when the hypotube expands, and a second portion of the hypotube includes a plurality of second struts that move apart from one another a second distance when the hypotube expands, the first distance being greater than the second distance.

12. The occlusion device of claim 1 , wherein the final shape is a coil shape.

13. The occlusion device of claim 1 , wherein the final shape is somewhat spherical in shape.

14. The occlusion 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. 15. A delivery system for an occlusion device according to any one of claims 1 to 14, comprising: The delivery system comprises: a delivery device having a lumen; a control wire positionable within the lumen of the delivery device and including a distal end, the distal end comprising: a constrained state, in which the distal end engages the occlusion device to facilitate movement of the occlusion device along at least a portion of the length of the lumen while constrained within the lumen of the delivery device; and an expanded state in which the delivery system engages the occlusion device while expanded outside the lumen of the delivery device.

16. The delivery system of claim 15 , further comprising a slider associated with the delivery device and the control wire to facilitate distal and proximal movement of the control wire through the lumen of the delivery device.

17. 1. A method for occluding a passageway or cavity in a body of a subject, comprising:

15. The method of claim 1 , further comprising the step of: delivering an occlusion device according to any one of claims 1 to 14 to a target location within the subject in a constrained state, said delivering comprising: introducing into the subject a delivery device in which the occlusion device and a portion of a control wire reside; advancing a distal tip of the delivery device to the target location; and advancing the control wire distally through the delivery device, the distal end of the control wire distally advancing the occlusion device until the occlusion device exits the distal tip of the delivery device; The step of introducing further comprises: When the occlusion device is introduced to the target location, expanding an outer diameter of the hypotube of the occlusion device to place the occlusion device in an expanded state; allowing the occlusion device to assume a final shape; and After the occlusion device is expanded and parked at the target location, withdrawing the control wire proximally through the delivery device, including withdrawing the distal end of the control wire from within the occlusion device; and withdrawing the delivery device from the body of the subject.

18. introducing the occlusion device to the target location, providing the occlusion device within a lumen of the delivery device; and providing the control wire within the lumen of the delivery device with the distal end of the control wire residing within the occlusion device.

19. When the occlusion device is introduced to the target location, 20. The method of claim 17, further comprising expanding the distal end of the control wire when the portion of the occlusion device in which the distal end resides exits the distal tip of the delivery device.

20. 18. The method of claim 17, wherein withdrawing the control wire proximally through the delivery device comprises pulling the occlusion device against the distal tip of the delivery device in the expanded state, and withdrawing the distal end of the control wire from within the occlusion device comprises continuing to pull the control wire proximally from within the occlusion device into the lumen of the delivery device.

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