Occlusion device with self-expanding struts

Abstract

A self-expanding occlusion device includes a hypotube. When deployed at a target location, the occlusion device self-expands or increases in outer diameter and automatically assumes its final shape. The occlusion device can retain its increased outer diameter and final shape by remaining exposed to one or more conditions at the target location.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) Priority is hereby claimed to the filing date of U.S. Provisional Patent Application No. 63 / 072,926, entitled "OCCLUSIVE DEVICE WITH MULTIPLE SELF-EXPANDING STRUTS, SHAPES, and METHODS," dated August 31, 2020 (the "'926 Provisional Application"). The entire disclosure of the '926 Provisional Application is hereby incorporated by reference herein.

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

[0003] Occlusion devices, including coils and plugs, are used to slow or stop the flow of blood within a subject's body and to occlude other voids within the subject's body for therapeutic or diagnostic purposes. Figures 1A and 1B, which show images of the same vasculature before and after placement of an occlusion device, respectively, illustrate the effect of the occlusion device on the subject's vasculature. Occlusion devices can be used for a variety of purposes, including treating arteriovenous malformations, hemorrhage, perforation, aneurysms, tumors (e.g., devascularization), varicose veins, congestion, and other conditions.

[0004] Occlusion devices, such as coils and plugs, are typically self-expanding devices designed to be constrained within a loading device, then pushed through a tubular catheter, sheath, needle, cannula (any of which is a "delivery device"), or other similar device to the target location(s), and then self-deploy to facilitate therapeutic occlusion by exiting the tip of the delivery device. Metal-based coils and plugs are more common than polymeric coils and plugs. Certain coils and plugs include polymers, fibers, coatings, fabrics, marker bands, and other features on the exterior of the metal or polymer scaffold, between scaffold features, and / or proximal or distal to the scaffold features.

[0005] White, Ken, and Croft, Calmes, "Coils in Nutshells: A Review of the Physical Properties of Coils"; AJNR , August 2008 ("White") (White, Ken, Cloft, and Kallmes, "Coils in a Nutshell: A Review of Coil Physical Properties," AJNR 2A and 2B, taken from the publication "White, August 2008," depict a particular design for an occlusion device comprising a coil. The coil shown in FIG. 2 includes a thin, solid wire 1° (initial structure or "initial wire") having a wire diameter D1. The thin, solid wire 1° transforms into a coiled wire 2° (secondary structure or "secondary spring" and / or "initial turn") having a coiled wire diameter D2. The coiled wire 2° transforms into a coiled tube 3° (tertiary structure) with a deployable diameter D3.

[0006] 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. As an example, a coil designed for a 0.018 inch (0.46 mm) delivery catheter will have a coiled wire diameter D2 of ∼0.018 inch (∼0.46 mm) OD, and a coil designed for a 0.035 inch (0.89 mm) delivery system will typically have a coiled wire diameter D2 of ∼0.035 inch (∼0.89 mm) OD. Manufacturers typically list their product offerings under broad headings such as "0.018 Coil," "0.035 Coil," and other sizes that refer to the coil's coiled wire diameter D2.

[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 3° coil tubing represents the final deployed, unconstrained OD, or third-stage, configuration of the coil. As an example, a 035 5 mm x 2 cm coil has a wire diameter D2 of 0.035 inches (0.89 mm), an unconstrained deployable diameter D3 of 5 mm, and a length of 2 cm. In clinical use, manufacturers vary in how they size coils for placement in the target anatomy. For example, the Ruby (Penumbra) and Azur CX (Terumo) coils recommend not oversizing for the anatomy—a 5 mm inner diameter (ID) vessel should receive a 5 mm deployable diameter D3 coil. However, Boston Scientific and Medtronic recommend that clinicians oversize their Interlock and Concerto coils by 10-20%, so that a 5mm ID vessel should be fitted with a 5.5mm or 6mm deployable diameter D3 coil. Certain plugs are recommended to be oversized by 30-50%.

[0009] Occlusive devices, including coil-shaped occlusive devices, can be manufactured to form any of a wide variety of tertiary shapes when deployed, including, for example, the coiled tube 3° shape or symmetrical helical shape depicted by FIGS. 2A and 3A, as well as a variety of other shapes including the asymmetrical helical shape shown in FIG. 3B, the funnel shape shown in FIGS. 3C and 3D, the ball shape shown in FIG. 3E, and various other shapes.

[0010] The configuration of a third stage of an occlusion device, such as a coil, can enable the device to perform a specific function, such as initial occlusion, framing, filling, packing, or another occlusion function. Occlusion coils and filling coils can be used within or adjacent to (e.g., behind) the coil providing the initial occlusion. Occlusion coils and filling coils can also be used within a void (e.g., an aneurysm sac) as shown in FIG. 4. The framing coil can frame a target, such as the neck of the void (e.g., the neck of an aneurysm), to enclose the occlusion coil and / or filling coil within the void and / or to enclose embolic material within the void. [Prior art documents] [Patent documents]

[0011] [Patent Document 1] U.S. Provisional Patent Application No. 63 / 072,926 [Non-patent literature]

[0012] [Non-Patent Document 1] White, Ken, Cloft, and Kallmes, “Coils in a Nutshell: A Review of Coil Physical Properties,” AJNR, August 2008 (“White”) Summary of the Invention [Problem to be solved by the invention]

[0013] While existing occlusion devices are useful, the occlusion they provide is limited by the extent to which the underlying structure of the device and any coatings or supporting materials on the underlying structure can be packed together when the occlusion device assumes its third stage shape. [Means for solving the problem]

[0014] An occlusion device according to the present disclosure comprises, consists essentially of, or consists of a self-expanding body that can be deployed in such a manner that it expands its outer diameter (OD) (i.e., a first degree of deployment) and allows the hypotube to assume a predetermined tertiary shape or its desired occlusion or final shape (i.e., a second degree of deployment).

[0015] In some embodiments, the body of the occlusion device may comprise a hypotube having a deployable section. The deployable section may include a plurality of slits that define struts. The slits may be arranged in a manner that allows the hypotube to expand from its native OD to a deployed OD. The hypotube may also be adapted to change shape in a manner that ultimately allows the hypotube to expand to its predetermined final shape or its desired occlusion shape.

[0016] The hypotube of the occlusion device may be formed from a substantially rigid material that can be constrained to a shape that facilitates insertion and / or removal of the hypotube from a subject's body, but can expand when the constraining force is removed. 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, embodiments in which the hypotube is made from a shape-memory material, the occlusion device can assume a desired or final shape when exposed to predetermined conditions (e.g., temperature, humidity, etc.) at the intended target location and when any constraining force is removed.

[0017] In some embodiments, rows of slits may be defined along the length of the deployable section of the hypotube of the occlusion device. Each row of slits may be positioned along a generatrix of the deployable section (i.e., a line extending parallel to the axis of the deployable section from one end of the hypotube to the other end of the deployable section). Alternatively, each row of slits may be oriented in a slight spiral around the hypotube. The slits in each row may be offset from the slits in an adjacent row. Each slit may overlap half of one slit in an adjacent row (if the slit is located at or near the end of the hypotube) or two slits in an adjacent row (if the slit is located intermediately); in other words, the slits in the deployable section may have a so-called "bricklay" arrangement, or they may be arranged like bricks in a so-called "longitudinal pattern." Such an arrangement of struts defined by the slits and adjacent rows of slits can enable the deployable section of the hypotube to assume a desired final shape (e.g., a symmetrical helical shape, an asymmetrical helical shape, a funnel shape, a modified funnel shape, a spherical shape, or any other desired shape).

[0018] In some embodiments, the slits in the deployable section of the hypotube of the occlusion device may be arranged in a manner that allows the struts to torque and / or twist or rotate as the deployable section, or a portion thereof, deploys. Such an arrangement may also allow the deployed portion of the deployable section to return to its undeployed state once a moderate restraining force is applied to the hypotube (e.g., when an external force restrains the hypotube into a tube, the tube diameter decreases, causing the rotating struts to rotate back to their flat, unrotated position, etc.). Such an arrangement may allow the deployable section to have a smooth outer surface when in a restrained or undeployed state.

[0019] Manufacturing an occlusion device according to the present disclosure may include cutting slits in the hypotube wall 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 for the occlusion device, may be solidified (e.g., by heating if the hypotube is formed from Nitinol). A restraining force may then be applied to the hypotube or occlusion device to contract or shrink the hypotube or occlusion device. The restraining force may contract the hypotube into a shape and size that facilitates its storage and subsequent insertion into a subject's body. In some embodiments, the occlusion device may be restrained within a loading device.

[0020] When it is desired to use the occlusion device, it can 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 the proximal end of the catheter and advanced through the catheter's lumen to the desired location. Once the occlusion device exits the distal tip of the catheter at the desired location, the occlusion device automatically assumes its increased outer diameter and intended final shape, thereby at least partially occluding the desired location in a desired manner. Conditions (e.g., temperature, etc.) at the target location may enable the occlusion device to self-deploy and automatically assume its final shape, and / or may enable the occlusion device to retain its increased outer diameter and final shape by remaining exposed to one or more conditions at the target location.

[0021] 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 skilled in the art through consideration of the ensuing description, the accompanying drawings, and the appended claims. [Brief explanation of the drawings]

[0022] [Figure 1A]1B shows an image of the vasculature before placement of the occlusion device, and together with FIG. 1B shows the effect of the occlusion device on the subject's vasculature. [Figure 1B] 1B is an image of the same vasculature as FIG. 1A after placement of an occlusion device, and together with FIG. 1A shows the effect of the occlusion device on the subject's vasculature. [Figure 2A] 1 depicts features of an existing occlusion device that includes a coil. [Figure 2B] Together with FIG. 2A, it depicts features of existing occlusion devices that include coils. [Figure 3A] 1 illustrates an embodiment of a coiled occlusion device with a symmetrical helical shape. [Figure 3B] 1 illustrates an embodiment of a coiled occlusion device with an asymmetric helical shape. [Figure 3C] 1 illustrates an embodiment of a coiled occlusion device with a funnel shape. [Figure 3D] 1 illustrates an embodiment of a coiled occlusion device with a modified funnel shape. [Figure 3E] 1 illustrates an embodiment of a coiled occlusion device with a somewhat spherical or ball-like shape. [Figure 4] 1 depicts an occlusion device within the space, i.e., within the aneurysm sac. [Figure 5A] 1 depicts an embodiment of an occlusion device having a body including a deployable section having an outside diameter (OD) that is deployable and contractible. [Figure 5B] 5A together depict an embodiment of an occlusion device having a body including a deployable section having an outside diameter (OD) that is both deployable and contractible. [Figure 5C] 5A-5B, taken together, depict an embodiment of an occlusion device having a body including a deployable section with an expandable and contractible outer diameter (OD). [Figure 5D] 5A-5C, taken together, depict an embodiment of an occlusion device having a body including a deployable section with an outside diameter (OD) that is both deployable and contractible. [Figure 6A-1] 1 provides an end view of a conventional occlusion device in its final configuration. [Figure 6A-2] 1 provides an isometric view of a conventional occlusion device in its final shape. [Figure 6B-1] 1 provides an end view of an embodiment of an occlusion device of the present disclosure with its body in its final shape but in an undeployed state. [Figure 6B-2] 1 provides an isometric view of an embodiment of an occlusion device of the present disclosure with its body in its final shape but in an undeployed state. [Figure 6C-1] 6B-1 and 6B-2 with its body in a deployed state and assuming its final shape. [Figure 6C-2] 6B-1 and 6B-2 with its body in a deployed state and assuming its final shape. [Figure 7B] 6B-1 and 6B-2 provides a detailed end view of the embodiment of the occlusion device shown in FIGS. 6B-1 and 6B-2, with its body in the undeployed state shown in FIGS. 6B-1 and 6B-2. [Figure 7C] 6C-1 and 6C-2 provides a detailed end view of the embodiment of the occlusion device shown in FIGS. 6C-1 and 6C-2, with its body in the deployed state shown in FIGS. 6C-1 and 6C-2. [Figure 8] 6C-1, 6C-2, and 7C is an isometric view of a variant of the embodiment of the occlusion device shown in FIG. 6C-1, 6C-2, and 7C, whose body is in the deployed state shown in FIG. 6C-1, 6C-2, and 7C, and at least one end of which is tapered. [Figure 9A] FIG. 10 is a side view of another embodiment of an occlusion device according to the present disclosure having a somewhat spherical shape. [Figure 9B] 9B is a cross-sectional view of an occlusion device according to the present disclosure having a somewhat spherical shape as shown in FIG. 9A. [Figure 9C] 9B is a perspective view of an occlusion device according to the present disclosure having a somewhat spherical shape as shown in FIG. 9A. [Figure 10]9A-9C show a variation of the embodiment of the occlusion device shown in FIGS. 9A-9C, in which the struts of the deployable section of the body of the occlusion device have serrated edges. [Figure 11] 1 depicts another final shape of an occlusion device according to the present disclosure. [Figure 12] 1 depicts an embodiment of an occlusion device with a deployable covering and / or filling material. [Figure 13] 1 depicts an embodiment of an occlusive device that includes a fabric or film covering. [Figure 14] 1 depicts an embodiment of a method for deploying an occlusion device at a target location within a subject's body. DETAILED DESCRIPTION OF THE INVENTION

[0023] 5A-5D, one embodiment of occlusion device 10 is depicted. Occlusion device 10 is shown in an undeployed or constrained state that facilitates introduction into and / or removal from a subject's body of occlusion device 10. As depicted in FIG. 5A, occlusion device 10 may be elongated while in the constrained state.

[0024] The occlusion device 10 includes a body 12. The body 12 can 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 include 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) alloys, nickel-chromium (NiCr or Nichrome) alloys (including, but not limited to, NiCr steel), stainless steels (e.g., 316L stainless steel, 316 stainless steel, etc.), and the like. Alternatively, the body 12 may be formed from a polymer. Suitable polymers may have a sufficient hardness (e.g., at least 35 Shore D, between 35 Shore D and 55 Shore D, between 35 Shore D and 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 as PEBAX®), and extruded plastics (provided they have a wall thickness that does not exceed the width of the struts 36, as discussed below).

[0025] The deployable segments 30 of the body 12 of the occlusion device 10 may be capable of deploying outward (e.g., radially outward) from the undeployed state shown in FIG. 5A to a deployed state and to a 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 deployable segments 30 may deploy to their final shape when exposed 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 deployable segments 30 may deploy to their final shape when a restraining force is removed from the body 12.

[0026] 5B-5D, the deployable section 30 may be defined by a series of slits 32 34a, 34b, 34c, etc. 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 only extend partially through the wall of the body 12 (e.g., from the outer surface of the wall toward the inner surface of the wall). The extent to which each slit 32 extends through the wall of the body 12 will depend, at least in part, on the material from which the body 12 is formed.

[0027] The slits 32 may have the same length as one another (apart from some slits 32 located at the ends of the deployable section 30). Adjacent slits 32 in a series, such as series 32a, 32b, 32c, are separated by solid, uncut regions of the body 12. These solid regions are sometimes referred to as junctures 38 or intersections.

[0028] Each series 34a, 34b, 34c, etc. may be defined by linearly aligned slits 32. The slits 32 and each series 34a, 34b, 34c, etc. may extend longitudinally along the body 12, with each series 34a, 34b, 34c, etc. positioned along a generatrix of the deployable section 30 (i.e., a line extending parallel to the longitudinal axis of the deployable section 30 from one end of the deployable section 30 to the other end of the deployable section 30). Such an orientation is sometimes referred to as a "linear" orientation. Alternatively, each series 34a, 34b, 34c, etc. may be oriented helically around the body 12.

[0029] The slits 32 in each series 34b, 34c, 34d, etc. may be offset relative to the slits 32 in each adjacent series 34a, 34b, 34c, 34d, 34e, etc. Each slit 32 within a series 34a, 34b, 34c, etc. may overlap one half of the circumferentially adjacent slits 32 in each adjacent series 34a, 34b, 34c, etc. (if the slits 32 are located at or near an end of the deployable section 30) or two (if the slits 32 are located midway along the length of the deployable section 30). Staggering the slits 32 around the circumference of the deployable section 30 of the body 12, with solid portions of the body 12 between the slits 32 arranged in a so-called "longitudinal stack pattern," gives the deployable section 30 a so-called "brickwork" appearance.

[0030] Circumferentially adjacent series 34a, 34b, 34c, etc. of slits 32 may be spaced equidistantly around the circumference of body 12. Deployable 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 spaced equidistantly around the circumference of body 12, each slit 32 of deployable section 30 may be staggered relative 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, and 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.

[0031] The solid portion of body 12 located between each adjacent pair of series 34a and 34b, 34b and 34c, 34c and 34d, etc. of slits 32 defines a strut 36 of deployable section 30. More specifically, each strut 36 may comprise the solid portion of body 12 between adjacent series 34a and 34b, 34b and 34c, 34c and 34d, etc. of slits 32. Stated another way, each slit 32 defines a gap between a pair of circumferentially adjacent struts 36. In embodiments in which series 34a, 34b, 34c, etc. are oriented along the longitudinal axis of body 12, the struts are also oriented along the longitudinal axis of body 12; and in embodiments in which series 34a, 34b, 34c, etc. are oriented helically around body 12, the struts 36 are also oriented helically or spirally around body 12.

[0032] Staggering the slits 32 may allow the deployable section 30 to deploy. In some embodiments, the struts 36 may rotate as the deployable section 30 deploys. Such rotation may occur, for example, in embodiments in which each ring of circumferentially aligned struts 36 about the deployable section 30 includes an even number of struts 36. As the slits rotate, they may protrude outward (e.g., radially) from the periphery of the deployable section 30, securing the occlusion device 10 in place.

[0033] In other embodiments, the slits 32 are not offset, and the struts 36 do not rotate when the deployable section 30 is deployed. In such embodiments, the resulting occlusion device 10 can still deploy and create multiple points of contact with the wall of the vessel or void in which the occlusion device 10 is placed, securing the occlusion device 10 in place within the vessel or void.

[0034] The expandability provided by the slits 32 and struts 36 of the deployable section 30 of the body 12 of the occlusion device 10 allows the outer diameter (OD) of the body 12 to expand, providing a first degree of deployment. Additionally, as the OD of the body 12 expands, the body 12 can assume a predetermined tertiary shape or a desired occlusion or final shape, providing a second degree of deployment.

[0035] 6A-6C contrast the occlusion resulting from a single degree of deployment, which occurs when a conventional occlusion device 110 assumes its final shape (FIGS. 6A-1 and 6A-2), with the occlusion resulting from two or more degrees of deployment, which occurs when an occlusion device 10 according to the present disclosure is deployed 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., a 0.35 5 mm x 2 cm coil) including a coiled wire 112 coiled to its final shape; the coil of the conventional occlusion device 110 is also seen in FIG. 6A-2. Such a conventional coiled occlusion device 110 reduces the area across the lumen (e.g., a vessel) in which it is placed (e.g., by approximately 59%). Notably, the OD of the coiled wire 112 does not expand.

[0036] 6B-1 and 7B provide end views of an embodiment of an occlusion device 10 of the present disclosure, with its body 12 in an undeployed state but in a coiled final shape (e.g., a 0.035 5 mm x 2 cm coil) as seen in FIG. 6B-2. The characteristic dimensions (e.g., its OD) of the body 12 of the occlusion device 10 may be the same 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).

[0037] While the OD of the coiled wire 112 of a conventional occlusion device 110 does not expand, as depicted in FIGS. 6C-1, 6C-2, and 7C, the OD of the body 12 of the occlusion device 10 of the present disclosure can expand (e.g., expand to twice its OD, such as 0.070 inches or 1.8 mm). As shown in FIG. 7C, the body 12 expands by opening its slits 32 around the circumference of the body 12. As shown in FIG. 6C-2, as the body 12 expands, it occupies an increased volume, allowing the occlusion device 10 to assume its final shape and provide improved occlusion (e.g., the occlusion device 10 reduces 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%, or about 92%).

[0038] 8, when body 12 of occlusion device 10 is in its deployed state, the OD of one or both ends 16, 17 of body 12 may be the same as the OD along the remainder (central portion) of 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 depicted embodiment, end 16 has the same OD as the majority of body 12 (e.g., an OD of 0.070 inches or 1.8 mm), while end 17 tapers to a smaller OD (e.g., an OD of 0.035 inches or 0.89 mm).

[0039] When deployed to its final shape, occlusion device 10 can assume any of a wide variety of predetermined shapes, including, but not limited to, those shown in Figures 3A-3E. Figure 11 depicts an embodiment of an occlusion device having a diamond or double funnel shape.

[0040] 9A-9C provide views of an embodiment of an occlusion device 10′ with a plug that has a somewhat spherical final shape when in its fully deployed state (i.e., when the body 12′ of the occlusion device 10′ has been deployed and allowed to assume its final shape). As depicted, when the body 12′ enters the deployed state, the struts 36′ rotate outward (e.g., up to about 90°, etc.), allowing the occlusion device 10′ to engage the tissue (e.g., the intima) against which it is positioned and deployed. Without limitation, 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″ with serrated edges.

[0041] Certain embodiments of an occlusion device 10 according to the present disclosure can be deployed, for example, from an OD of about 0.035 inches (about 0.89 mm) to an OD of about 0.070 inches (about 1.8 mm). Such an occlusion device 10 having a symmetrical helical final shape with dimensions of about 5 mm by 2 cm can have 50% less metal mass than a conventional occlusion device 10 having an OD of about 0.035 inches (about 0.89 mm) and the same final shape and final dimensions. For example, a standard 035 5 mm by 2 cm coil with 0.005 inch (0.13 mm) wire will have a mass of 2.387 mm. 3 / cm of metal volume, whereas a 035 5 mm x 2 cm coil occlusion device 10 according to the present disclosure formed from hypotubing having a wall thickness of 0.0018 inches (0.046 mm) has a metal volume of 1.015 mm / cm. 3 / cm of metal volume. Thus, the occlusion device 10 of the present disclosure can reduce the metal volume and mass by about 50% to about 80% compared to the mass of conventional occlusion devices of similar size.

[0042] Reducing the metal mass should reduce computed tomography (CT) artifacts of the occlusion device 10 after it is implanted in a subject's body. Certain subject patients with existing conventional occlusion devices may not be effectively imaged using CT for future follow-up due to the size or location of the CT artifacts generated by such conventional occlusion devices. Necessarily, follow-up may require invasive angiography. Subjects receiving a metallic occlusion device 10 according to the present disclosure will be able to undergo future follow-up CT scans due to the reduced CT artifacts.

[0043] In some embodiments, an occlusion device 10, 10', 10'', 10''', 10'''' (hereinafter referred to as occlusion device 10 for brevity) according to the present disclosure 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 provide even more occlusion. The coating may extend over the outer surface of the body 12, 12', 12'', 12''', 12'''', etc. (hereinafter referred to as body 12 for brevity) of the occlusion device 10. The filler material may be confined by the lumen of the hypotube defining the body 12 of the occlusion device 10. In some embodiments, the coating and / or filler material may be affixed to the body 12.

[0044] In one example, the coating and / or filler material may comprise a foamable hydrogel that may swell to increase fill volume and packing density once the occlusive device 10 is in place. As another example, depicted in FIG. 12, the occlusive device 10''' may be provided with a foamable 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 (2,2,4- and 2,4,4-mixture) (TMHDI), or the like. In another example, the occlusive device 10 may be provided with a flexible filament. A flexible filament may be provided, wherein the flexible filament may be disposed within the lumen of the body 12, extend through the slit 36 ​​(FIGS. 5B-5D), and / or be disposed on the outer surface of the body 12. As yet another example depicted in FIG. 13, a fabric (e.g., PTFE, etc.) or a film 50 (e.g., a polymeric film, etc.) may cover at least a portion of the body 12'''' (e.g., its outer surface and / or its inner surface) in a manner that prevents fluid from flowing through the open slit 36'''' (FIGS. 5B-5D) of the body 12'''' of the occlusion device 10''''.

[0045] In addition to or as an alternative to enhancing the occluding ability of occlusion device 10, the coating and / or filler material may provide additional properties to occlusion device 10. For example, the coating and / or filler material may be adapted to absorb fluids from the subject's body and facilitate embolization.

[0046] In another example, a filler material may provide radiopacity to the occlusion device 10. Such a filler material may be affixed to the body 12 in a manner that allows the filler material to deploy with and / or within the body 12 and prevents the filler material from migrating out of the body 12 when in the deployed state. Such a filler material may comprise cotton, nylon, fiber, filament, and / or other suitable materials. The filler material may also be absorbable. In some embodiments, the filler material can be fabricated using 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.

[0047] 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, and the like, which may be applied to the filler material during manufacturing or may be applied by a clinician at the tableside during the procedure, prior to, during, or after deployment.

[0048] A clinician may inject a substance into the shipping or storage tube containing the occlusion device 10 before loading the occlusion device 10 into a catheter for delivery into the subject's body. Any filler material in the occlusion device 10 may be adapted to absorb or otherwise carry the substance. In embodiments in which the substance comprises a contrast agent, the contrast agent is radiopaque under fluoroscopic x-rays to guide the occlusion device 10 as it is pushed through the catheter to the target location during deployment and during deployment of the occlusion device 10 at the target location. After deployment, the contrast agent can diffuse, elute, and / or wash out of the occlusion device 10. This allows the occlusion device 10 to be visible during deployment, but reduces x-ray visualization after deployment, which may be advantageous for viewing adjacent anatomical structures and lesions. In embodiments in which the substance comprises a drug, a therapeutic agent (e.g., an oncolytic radioisotope, such as yttrium-90 (Y90) during a radioembolization procedure), a nutrient, a diagnostic reagent, a marker, a targeting compound, or the like, the substance may be adapted to be eluted once the occlusion device 10 is placed at the target location.

[0049] Optionally, the clinician may inject a substance into the catheter delivering the occlusion device 10 while the occlusion device 10 is being deployed (with or without a filler material) and before or while the occlusion device is being 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 allows the substance to dissipate after the occlusion device 10 is in place at its target location.

[0050] As another option, a substance may be introduced into the occlusion device 10 or into its filler material through a catheter after the occlusion device 10 has been deployed.

[0051] The substance may also be applied directly to the body 12 of the occlusion device 10 (e.g., to one or more struts 36 thereof). The substance may be stuck, painted, glued, or otherwise applied to the body 12 of the occlusion device 10. As another option, a substance-carrying band (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.

[0052] In some embodiments, occlusive device 10 may include a sensor. The sensor may comprise a passive sensor or an active sensor. The sensor may be disposed within or affixed to body 12 of occlusive device 10. In some embodiments, the sensor may comprise a radio frequency identification sensor or chip.

[0053] A method for manufacturing the occlusion device 10 may employ a hypotube (e.g., a 0.035 inch (0.89 mm) OD and ∼0.030 inch (∼0.76 mm) ID nitinol hypotube, etc.). Slits 32 (FIGS. 5B-5D) may be cut into the hypotube by any suitable process (e.g., laser cutting, mechanically (e.g., by computer numerical control (CNC) machining, etc.), by electrical discharge machining (EDM), chemically etching, etc.). The slits 32 may be cut end-to-end through the hypotube such that the outer diameter of the hypotube expands consistently along its entire length. 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, one or more intermediate locations). The constrained locations may be useful for a variety of purposes, such as to hold material within the occlusion device 10, to provide connection points for deployment mechanisms that facilitate deployment and / or positioning of the occlusion device 10, or to connect the occlusion device 10 to another occlusion device.

[0054] Cutting slits 32 in the hypotube can result in struts 36 with edges that are dull or sharp. Additionally, cutting slits may include defining features along the edges of the struts 36, such as teeth, serrations, roughened edges, or the like. Such features may allow the resulting occlusion device 10 to be anchored in place at 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 at a target location.

[0055] 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 burnished. In other embodiments, the edges may be sharpened.

[0056] Additionally, other features may 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 be adapted to engage with a deployment mechanism (e.g., a detachable pusher). In certain embodiments, one or more round (e.g., 0.003 inch or 0.076 mm diameter) female recesses or channels may be formed in the hypotube end 16; that is, these female recesses or channels may be adapted to receive extendable / retractable round (e.g., 0.003 inch (0.076 mm) or smaller diameter) male features of a deployment mechanism. The connection is sufficiently rigid for a user to push or pull the occlusion device 10 through a delivery device 200 ( FIG. 14 ), such as a catheter, sheath, cannula, needle, or the like.

[0057] 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.). Once the slit hypotube is loaded onto the mandrel, it may expand, increasing its ID and OD (e.g., to about 0.075 inches or about 1.9 mm). Expanding the slit hypotube will open the slits 32 in the hypotube and expose the hypotube struts 36 (FIGS. 5B-5D). The expanded slit hypotube may then be heated to a sufficient temperature (e.g., about 400°C to about 600°C) for a sufficient duration (e.g., up to 1 hour) to solidify the nitinol into its expanded state. The hypotube is then cooled, while the hypotube may remain on the mandrel, or the hypotube may be removed from the mandrel. The cooled hypotube is re-constrained to its original OD by physically squeezing the OD and / or by forcing the deployed hypotube into a funnel-shaped hypotube fixture that funnels from an ID of ∼0.080 inches (approximately 2.0 mm) to approximately 0.035 inches (approximately 0.89 mm) or less. The constrained hypotube can then be loaded (e.g., pushed) into a shipping or storage tube that will 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.

[0058] 14 , one method of using occlusion device 10 includes advancing a distal tip 202 of a delivery device 200, such as the depicted catheter, sheath, cannula, needle, or the like, to a target location T within a subject's body. Occlusion device 10 may be transferred from a loading apparatus (not shown) into the 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 or is deployed from distal tip 202, occlusion device 10 can at least partially unfold and be positioned against a surface of target location T (e.g., against the intima, etc.). Deployment may be achieved by pushing the constrained occlusion device 10 distally out of the distal tip 202 (e.g., using the deployment mechanism 210, etc.) and / or by pulling the delivery device 200 proximally while maintaining the position of the occlusion device 10 within the subject's body (e.g., at the target location T, etc.).

[0059] Once the occlusion device 10 is fully deployed from the distal tip 202, the occlusion device 10 can assume its final shape.

[0060] After occlusion device 10 exits delivery device 200, deployment mechanism 210 may remain connected to occlusion device 10, which may allow the clinician to verify placement accuracy. Optionally, the clinician may push, pull, drag, or otherwise move at least partially deployed occlusion device 10 (e.g., using deployment mechanism 210) in a manner to position occlusion device 10 at target location T. Such movement may further ablate, agitate, or mechanically irritate the intima at target location T to elicit an inflammatory response (with or without optional sclerosing agent injection), thereby facilitating temporary or permanent immobilization of occlusion device 10 at target location T, and thus temporary or permanent embolization.

[0061] 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 detach the deployment mechanism 210 from the occlusion device 10).

[0062] Without limitation, an occlusion device 10 according to the present disclosure can be used to promote luminal filling, reduce flow, improve thrombosis, improve proliferation, reduce radiographic density, or otherwise promote occlusion. Such an occlusion device 10 can be used in connection with a variety of conditions, including, but not limited to, arteriovenous malformations, hemorrhage, perforation, aneurysms, fibroids, varicose veins, congestion, distal embolism, and other conditions. The occlusion device 10 can also be used to treat COVID-19 patients who have elevated D-dimer levels (fibrin protein antigen fragments found in blood tests suggesting coagulation disorders) and who have developed life-threatening blood clots in the heart, lungs, brain, and peripheral vessels. Hemorrhage is a complication of blood clots, and hemorrhage can be treated using an embolic device. For example, see the following documents: 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 / See, for example, US Pat. No. 6,299,499, the disclosures of which are hereby incorporated by reference.

[0063] The following describes examples of the present invention. [Embodiment 1] An occlusion device comprising a hypotube that self-expands to an increased outer diameter and final shape when deployed to a target location within a subject's body, wherein the increased outer diameter and final shape can at least partially occlude a passageway through a portion of the subject's body. [Embodiment 2] 10. The occlusive device of embodiment 1, An occlusion device wherein the hypotube self-expands to the increased outer diameter and to the final shape when exposed to predetermined conditions within a subject's body. [Embodiment 3] 3. The occlusive device of embodiment 2, An occlusion device wherein the hypotube self-expands to the increased outer diameter and to the final shape when exposed to body temperature. [Embodiment 4] 4. The occlusion device of any one of embodiments 1 to 3, The occlusion device, wherein the hypotube comprises a shape memory material. [Embodiment 5] 5. The occlusive device of embodiment 4, The occlusion device, wherein the shape memory material comprises nitinol. [Embodiment 6] 6. The occlusion device of any one of embodiments 1 to 5, An occlusion device wherein the increased outer diameter of the hypotube is at least 100% of the constrained outer diameter of the hypotube. [Embodiment 7] 7. The occlusion device of any one of embodiments 1 to 6, The occlusion device, wherein the final shape comprises a coil. [Embodiment 8] 8. The occlusion device of any one of embodiments 1 to 7, An occlusion device wherein the hypotube in its final shape attempts to occlude at least about 75% of the cross-sectional area of ​​the passageway through the portion of the subject's body, at least about 80% of the cross-sectional area of ​​the passageway through the portion of the subject's body, at least about 85% of the cross-sectional area of ​​the passageway through the portion of the subject's body, or at least about 90% of the cross-sectional area of ​​the passageway through the portion of the subject's body. [Embodiment 9] 9. The occlusion device of any one of embodiments 1 to 8, The occlusion device further comprising a filler material within the lumen of the hypotube. [Embodiment 10] 10. The occlusive device of embodiment 9, An occlusive device, wherein the filler comprises an absorbent material. [Embodiment 11] 10. The occlusive device of embodiment 9, The occlusion device, wherein the filler comprises a radiopaque material. [Embodiment 12] 12. A method of occluding a passageway or void in a subject's body using the occlusion device of any one of claims 1 to 11, comprising: introducing the occlusion device in a constrained state to a target location within the body of the subject; when the occlusion device is introduced into the target location. expanding the outer diameter of the hypotube of the occlusion device; and allowing the occlusion device to assume its final shape; A method of providing [Embodiment 13] 13. The method of embodiment 12, wherein: The method, wherein the step of introducing the occlusion device to the target location comprises the step of exposing the occlusion device to at least one condition that causes the outer diameter of the occlusion device to self-expand and the occlusion device to automatically assume the final shape. [Embodiment 14] 14. The method of embodiment 12 or 13, The introduction process is advancing the occlusion device through an insertion device to the target location; and expelling the occlusion device from the distal tip of the insertion device at the target location. While the above disclosure provides many details, these should not be construed as limiting the scope of any appended claims, but merely as providing illustrations of some embodiments of elements and features of the disclosed subject matter. Other embodiments of the disclosed subject matter and other embodiments of those elements and features may be devised that do not depart from the spirit or scope of any appended claim. Features from different embodiments may also be employed in combination. Accordingly, the scope of each claim is limited only by its plain language and its legal equivalents. [Explanation of symbols]

[0064] 10, 10', 10'', 10'''', 10'''' Occlusion Device 12, 12', 12'', 12'''' body 16, 17 End of the body 30 Expandable categories 32, 32'' slit 34a, 34b, 34c Slit series 36, 36', 36'' strut 38 Joint 40 Expandable polymer foam or mesh 50 films 110 Conventional Occlusion Devices 112 Coiled Wire 200 Delivery Device 202 Distal tip 204 proximal end 210 Deployment mechanism D1 wire diameter D2 Coiled Wire Diameter D3 Deployable Diameter T Target location

Claims

1. An occlusion device comprising a hypotube that, when deployed at a target location within a subject's body, self-expands to an increased outer diameter and changes from an initial shape having a tubular shape to a final shape having a spherical, spheroidal, diamond-shaped, or asymmetrical helical shape, wherein the increased outer diameter and the final shape of the hypotube can at least partially occlude a passageway through a portion of the subject's body.

2. An occlusion device comprising a hypotube having incisions defining struts that self-expand to an increased outer diameter and rotate as the hypotube changes shape to a final shape when deployed to a target location within a subject's body, wherein the increased outer diameter and final shape of the hypotube can at least partially occlude a passage through a portion of the subject's body.

3. 3. The occlusion device of claim 1 or 2, An occlusion device wherein the hypotube self-expands to the increased outer diameter and changes shape to the final configuration when exposed to predetermined conditions within a subject's body.

4. 4. The occlusion device of claim 3, An occlusion device wherein the hypotube self-expands to the increased outer diameter and changes shape to the final configuration when exposed to body temperature.

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

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

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

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

9. 9. The occlusion device of claim 8, An occlusion device, wherein the coil comprises an asymmetric helical shape.

10. 8. The occlusion device of claim 1, The occlusion device, wherein the final shape comprises a diamond shape.

11. 8. The occlusion device of claim 1, The occlusion device, wherein the final shape comprises a sphere.

12. 12. The occlusion device of any one of claims 1 to 11, An occlusion device wherein the hypotube in its final shape attempts to occlude at least about 75% of the cross-sectional area of ​​the passageway through the portion of the subject's body, at least about 80% of the cross-sectional area of ​​the passageway through the portion of the subject's body, at least about 85% of the cross-sectional area of ​​the passageway through the portion of the subject's body, or at least about 90% of the cross-sectional area of ​​the passageway through the portion of the subject's body.

13. 13. The occlusion device of any one of claims 1 to 12, The occlusion device further comprising a filler material within the lumen of the hypotube.

14. 14. The occlusion device of claim 13, An occlusive device, wherein the filler comprises an absorbent material.

15. 14. The occlusion device of claim 13, The occlusion device, wherein the filler comprises a radiopaque material.

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