Vascular occlusion device

Abstract

The vascular occlusion device includes an occlusion device configured to be slidably received within a catheter and deployed from the catheter. The occlusion device includes a wire that has a primary shape when disposed within the catheter and a secondary shape when released from the catheter. The primary shape is defined by a plurality of loops in a linearly extended configuration. All of the plurality of loops are longitudinally spaced apart and include a plurality of upper loops and a plurality of lower loops. In the secondary shape, the plurality of upper loops have a configuration in which they overlap longitudinally, and the plurality of lower loops have a configuration in which they overlap longitudinally.

Description

Technical Field

[0001] The present disclosure relates to medical devices, and more particularly to vascular occlusion devices and methods for using such medical devices. This application claims the benefit of priority of U.S. Provisional Application No. 63 / 366,914, filed on Jun. 23, 2022, the entire disclosure of which is incorporated herein by reference.

Background Art

[0002] For example, a wide variety of medical devices, including those used to occlude blood vessels in the treatment or prevention of pathological conditions, have been developed for medical use. These medical devices can be used in various blood vessels and are manufactured and used according to any one of a variety of different methods. Known medical devices and methods each have specific advantages and disadvantages. There is still a need to provide alternative medical devices, as well as alternative methods for manufacturing and using medical devices.

Summary of the Invention

[0003] The present disclosure provides designs, materials, manufacturing methods, and use alternatives for medical devices. An exemplary occlusion device configured to be slidably received within a catheter and deployed from the catheter includes a single wire having a primary shape when disposed within the catheter and a secondary shape when released from the catheter. The primary shape is defined by a plurality of loops in a linearly extended configuration, all of the plurality of loops being longitudinally spaced apart and including a plurality of upper loops extending above the longitudinal axis of the occlusion device and a plurality of lower loops extending below the longitudinal axis. In the secondary shape, the plurality of upper loops have a longitudinally overlapping configuration and the plurality of lower loops have a longitudinally overlapping configuration.

[0004] Alternatively or additionally to the above embodiment, in the secondary shape, the plurality of upper loops do not overlap the plurality of lower loops. Alternatively or additionally to any of the above embodiments, the configuration overlapping in the longitudinal direction defines a series of figure-eight shapes overlapping in the longitudinal direction.

[0005] Alternatively or additionally to any of the above embodiments, the single wire is a helical coil formed by a plurality of first loops, each of the plurality of first loops having a first outer diameter, and each of the first outer diameters being substantially the same.

[0006] Alternatively or additionally to any of the above embodiments, each of the plurality of upper loops and the plurality of lower loops has a second outer diameter larger than the first outer diameter, and each of the second outer diameters is substantially the same.

[0007] Alternatively or additionally to any of the above embodiments, the secondary shape is formed by upper loops and lower loops alternately arranged in the longitudinal direction. Alternatively or additionally to any of the above embodiments, at least some of the plurality of loops in the primary shape are open and define a meandering shape.

[0008] Alternatively or additionally to any of the above embodiments, at least some of the plurality of loops in the primary shape are closed. Alternatively or additionally to any of the above embodiments, all of the upper loops and the lower loops in the secondary shape are closed.

[0009] Alternatively or additionally to any of the above embodiments, the single wire automatically changes from the primary shape to the secondary shape when the wire is released from the catheter.

[0010] Alternatively or additionally to any of the above embodiments, the wire is formed of nitinol. Alternatively or additionally to any of the above embodiments, the cross-section of the wire is circular, and the diameter of the cross-section is in the range of 0.05 mm to 0.3 mm.

[0011] Alternatively or additionally to any of the above embodiments, the distal end of the plugging device defines a non-traumatic end, and the proximal end of the plugging device does not have a coupling element. Alternatively or additionally to any of the above embodiments, the plugging device further includes a plurality of fiber bundles coupled to the wire.

[0012] An exemplary vascular occlusion system includes a catheter having a lumen with a delivery end, and a plugging device slidably received within the lumen of the catheter and configured to be deployed from the lumen. The plugging device includes a single wire having a primary shape when disposed within the lumen of the catheter and a secondary shape when released from the delivery end. The primary shape is defined by a plurality of loops in a linearly extended configuration, all of the plurality of loops being longitudinally spaced apart, and in the secondary shape, the plurality of loops includes a plurality of upper loops and a plurality of lower loops having a longitudinally overlapping configuration.

[0013] Alternatively or additionally to any of the above embodiments, the longitudinally overlapping configuration is a series of figure eights that longitudinally overlap. Alternatively or additionally to any of the above embodiments, the secondary shape is formed by upper loops and lower loops alternately arranged longitudinally.

[0014] Alternatively or additionally to any of the above embodiments, at least some of the plurality of loops in the primary shape are open and define a meandering shape. Alternatively or additionally to any of the above embodiments, at least some of the plurality of loops in the primary shape are closed.

[0015] Another exemplary vascular occlusion system includes a catheter having a lumen with a delivery end, and an occlusion device slidably received within the lumen of the catheter and configured to deploy from the lumen. The occlusion device includes a single wire having a primary shape when disposed within the lumen of the catheter and a secondary shape when released from the delivery end. The primary shape is defined by a plurality of loops in a linearly extended configuration, all of the plurality of loops being longitudinally spaced apart, and in the secondary shape, the plurality of loops include a plurality of upper loops and a plurality of lower loops having a longitudinally overlapping configuration. The occlusion device includes a pusher member disposed within the lumen, the pusher member having a distal end configured to push the proximal end of the occlusion device out of the lumen, and the pusher member and the occlusion device are not coupled together.

[0016] The above summaries of some embodiments, aspects, and / or examples are not intended to describe every embodiment or every implementation of the present disclosure. The drawings and the detailed description illustrate these embodiments more specifically.

[0017] The present disclosure can be more fully understood by considering the following detailed description of various embodiments in connection with the accompanying drawings.

Brief Description of the Drawings

[0018]

Fig. 1A

Fig. 1B

Fig. 2

Fig. 3

Fig. 4

Fig. 5

[0019] Aspects of the present disclosure are capable of various modifications and alternative forms, and specific forms of the present disclosure are shown by way of example in the drawings and will be described in detail below. However, it is not intended to limit the aspects of the present disclosure to the specific embodiments described below. Furthermore, it is intended to embrace all modifications, equivalents, and alternative forms that fall within the spirit and scope of the present disclosure.

[0020] The following terms, unless otherwise defined in the claims or elsewhere in this specification, shall have the following definitions applied to them. All numerical values are assumed to be modified by the term "about" whether or not explicitly shown in this specification. The term "about" refers to a range of numerical values that a person of ordinary skill in the art would generally consider to be equivalent (e.g., having the same function or result) in the context of the numerical value. In many cases, the term "about" may include numbers rounded to the nearest significant digit. Other uses of the term "about" (e.g., in contexts other than numerical values) may be assumed to have their ordinary conventional definitions (one or more) understood from and consistent with the context of this specification, unless otherwise specified.

[0021] The recitation of numerical ranges by endpoints includes all numbers within that range including the endpoints (e.g., 1 - 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some preferred dimensions, ranges, and / or values are disclosed for various components, features, and / or specifications, those skilled in the art to which this disclosure pertains will understand that the desired dimensions, ranges, and / or values may deviate from those explicitly disclosed.

[0022] As used in this specification and the claims, the singular form "one" includes plural referents unless the content clearly dictates otherwise. The term "or" as used in this specification and the claims is generally used in the sense of "and / or" unless the content clearly dictates otherwise. For ease of understanding, some features of the present disclosure may be described in the singular even though those features may be plural or repeated in the disclosed embodiment(s). Each instance of a plurality of features may include and / or be encompassed by a singular disclosure unless explicitly stated to the contrary. For brevity and clarity, not all elements of the present disclosure are necessarily shown in each figure or described in detail below. The following description is understood to be equally applicable to any and / or all of two or more existing components unless explicitly stated to the contrary. Also, for clarity, not all instances of some elements or features are shown in each figure.

[0023] Relative terms such as "proximal", "distal", "advancing", "retreating", and their derivatives can generally be considered with respect to the positioning, direction, and / or movement of various elements relative to the user / operator / pilot of the device, where "proximal" and "retreating" indicate or refer to being closer to or towards the user, and "distal" and "advancing" indicate or refer to being farther from or away from the user. In some instances, the terms "proximal" and "distal" may be arbitrarily assigned for ease of understanding of the present disclosure, and such instances may be readily apparent to those skilled in the art. Other relative terms such as "upstream", "downstream", "inflow", "outflow", etc. refer to the direction of fluid flow within a body lumen, blood vessel, etc., or the direction of fluid flow within the device.

[0024] The term "extent" can be understood to mean the maximum measured dimension of a dimension described or specified, unless the dimension or size in question is preceded by "minimum" or specified as "minimum", where "minimum" can be understood to mean the minimum measured dimension of a dimension described or specified. For example, "outer extent" can be understood to mean the maximum outer dimension, "radial extent" can be understood to mean the maximum radial dimension, and "longitudinal extent" can be understood to mean the maximum longitudinal dimension. Each instance of "extent" can be various (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and can be apparent to those skilled in the art from the context of individual use. Generally, "extent" can be considered the maximum possible dimension measured in accordance with the intended use, and "minimum extent" can be considered the minimum possible dimension measured in accordance with the intended use. In some instances, "extent" can generally be measured at right angles within a plane and / or in a cross-section, but can be measured variously, without being limited thereto, such as at an angle, radially, circumferentially (e.g., along an arc), etc., as may be apparent from a particular context. Also, the term "substantially", when used in relation to two dimensions being "substantially the same", generally refers to a difference of 5% or less.

[0025] The terms "monolithic" and "single-piece" generally refer to one or more elements made or consisting of a single structure or base unit / element. Monolithic and / or single-piece elements shall exclude structures and / or features made by assembling or joining together a plurality of separate elements.

[0026] References to "embodiments", "some embodiments", "other embodiments", etc. in this specification mean that while the described embodiments may include certain features, structures, or characteristics, not all embodiments necessarily include those specific features, structures, or characteristics. Also, such phrases do not necessarily refer to the same embodiment. Further, when a particular feature, structure, or characteristic is described in relation to an embodiment, unless explicitly stated to the contrary or clearly prohibited, one of ordinary skill in the art would recognize that such a particular feature, structure, or characteristic can also affect other embodiments. That is, various individual elements described below can be combined or arranged with each other to form additional embodiments or to complement and / or enhance the described embodiments, even if not explicitly shown in a particular combination.

[0027] For clarity purposes, throughout the specification and / or claims, certain numerical terms (e.g., first, second, third, fourth, etc.) may be used to name and / or distinguish various features described and / or features of the claims from each other. This numerical terminology is not intended to be limiting, but is merely illustrative. In some embodiments, for simplicity and clarity, changes and deviations from previously used numerical terms may occur. That is, a feature identified as a "first" element may later be referred to as a "second" element, a "third" element, etc., or may be completely omitted, and / or different features may be referred to as the "first" element. The meaning and / or designation in each case should be apparent to one of ordinary skill in the art.

[0028] The following description should be read with reference to the drawings, which are not necessarily to scale, but like elements are given the same number in different drawings. The detailed description and the drawings are intended to illustrate, not to limit, the present disclosure. One of ordinary skill in the art will recognize that the various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and the drawings show exemplary embodiments of the present disclosure. However, for clarity and ease of understanding, not all features and / or elements may be shown in each drawing, and it can be understood that the features and / or elements exist independently of each other unless otherwise specified.

[0029] Many diseases or conditions, not limited to these, such as hemorrhage, aneurysm, venous insufficiency, occlusion of blood flow prior to organ resection, or prevention of embolization bead backflow into branch vessels within the liver, can benefit from vascular occlusion. Embolization devices can be used to achieve vascular occlusion by closing blood vessels and / or filling an aneurysm sac.

[0030] In some embodiments, the vascular occlusion device can include an occlusion device made of a wire that has a primary shape when disposed within a delivery catheter and a secondary shape when released from the delivery catheter. As shown in FIG. 1A, the wire 12 can be a single linear wire piece with a rounded distal tip 14. In other embodiments, as shown in FIG. 1B, the wire 12 forming the occlusion device can be a single wire wound multiple times to form a generally tubular structure such as a helical coil 5 with a rounded distal tip 14. The helical coil 5 can be formed from a series of continuous loops or windings having a constant pitch or an alternating pitch over the length of the helical coil 5. The helical coil 5 can be formed by a plurality of first loops 16 each having a first outer diameter D1. The first outer diameters D1 of the plurality of first loops 16 may be substantially the same or different as shown in FIG. 1B. In some embodiments, a suture or inner wire 13 can be at least partially disposed within the helical coil 5. The suture or inner wire 13 can provide support particularly when the helical coil 5 is formed from a soft wire 12.

[0031] In both embodiments shown in FIGS. 1A and 1B, the wire 12 can be formed to include a non-traumatic distal tip 14 that prevents damage to the patient's vasculature while the occlusion device moves within the patient's vasculature. The distal tip 14 can be the rounded end of the wire 12. The distal end of the wire 12 can be polished to form a rounded smooth end or heated to form a rounded end or ball. In other embodiments, the distal tip 14 can be made of a non-radiopaque polypropylene. Alternatively, the distal tip 14 can function as a distal implant marker that enables the occlusion device to be positioned in place under fluoroscopic observation. In some embodiments, the distal tip 14 can be made of a radiopaque material such as a platinum / iridium alloy.

[0032] Wire 12 can be wound so as to form a primary shape when disposed within and constrained by the delivery catheter, and to form a secondary shape when released from the delivery catheter. The following description refers to occlusion devices 10, 100 made from wires 12, 112, but wires 12, 112 may be a single straight wire 12 as shown in FIG. 1A, or a single wire formed into a helical coil 5 as shown in FIG. 1B. In other embodiments, wire 12 or helical coil 5 may be formed from multiple wires such as a braid or a twisted bundle.

[0033] In some embodiments, as shown in FIG. 1B, a plurality of thrombogenic fiber bundles 17 may be attached to wires 12, 112 or helical coil 5 at predetermined intervals to enhance coil thrombosis. Generally, fiber bundle 17 includes a plurality of fibers extending from a single attachment point as shown. However, in some embodiments, a fiber bundle may be constituted by a single fiber. Fiber bundle 17 may be formed of polyethylene terephthalate or nylon. Fiber bundle 17 is described in more detail in U.S. Patent No. 10,524,799 to O'Connor et al., the disclosure of which is incorporated herein by reference.

[0034] FIG. 2 shows an occlusion device 10 comprising a proximal region 18 constrained in a primary shape within the lumen of a delivery catheter 15, a distal region 22 having a secondary shape outside the delivery catheter, and an intermediate region 20 where the occlusion device 10 transitions from the primary shape to the secondary shape as the occlusion device exits the delivery catheter. In some embodiments, the occlusion device 10 may be formed from a single wire 12 such that the entire occlusion device has a monolithic structure. In other embodiments, the occlusion device 10 may be formed from a plurality of wires 12 that form a plurality of secondary shapes. The wire 12 may automatically change from the primary shape to a predetermined secondary shape when the wire is released from the delivery end of the delivery catheter 15. For example, the wire 12 may be made of a nickel-titanium alloy (e.g., nitinol) having both mechanical shape memory properties and thermal shape memory properties. However, in other embodiments, the wire 12 may be made of any material exhibiting mechanical and / or thermal shape memory properties, or may be made of platinum, a platinum alloy, tungsten, a tungsten alloy, or other similar materials. The wire 12 may be permanently processed in the secondary shape by heat setting or other methods so as to automatically transition from the primary shape to the secondary shape when exiting the delivery catheter 15. In some embodiments, the wire 12 may have a circular cross-section with a diameter in the range of 0.05 mm to 0.3 mm.

[0035] In the embodiment shown in FIG. 2, the proximal region 18 has a primary shape defined by a plurality of loops 30 in a linearly extended configuration, and all of the plurality of loops are longitudinally spaced apart. The plurality of loops 30 includes a plurality of upper loops 32 extending above the longitudinal axis X-X of the plugging device 10 and a plurality of lower loops 34 extending below the longitudinal axis, as shown in FIG. 2. At least some of the plurality of upper loops 32 and the plurality of lower loops 34 in the primary shape are open and define a meandering shape. This meandering shape is defined by a series of wavy peaks (upper loops 32) and valleys (lower loops 34), as shown in the proximal region 18 and the intermediate region 20. In the intermediate region 20, when the plugging device 10 exits the delivery catheter 15 and begins to transition to the secondary shape, the plurality of upper loops 32 move closer to each other longitudinally, and the plurality of lower loops 34 move closer to each other longitudinally. As shown in FIG. 2, the secondary shape is formed by upper loops 32 and lower loops 34 alternately arranged longitudinally. As the plugging device 10 continues to move distally beyond the delivery catheter 15, as shown in the distal region 22, the plurality of upper loops 32 continue to move closer to each other until they overlap each other longitudinally, and the plurality of lower loops 34 continue to move closer to each other until they overlap each other longitudinally.

[0036] In some embodiments, the proximal end portion 11 and / or region of the wire 12 may not have a coupling structure configured to removably engage with a delivery device. The proximal end of the wire 12 can be a non-traumatic end that is polished to a rounded shape or melted into a ball shape, similar to the distal tip 14 described above. Instead of using a coupling device to deliver the plugging device 10, the plugging device 10 is extruded from the delivery catheter 15 in a one-way deployment. The pusher member 19 can be advanced through the delivery catheter 15 to extrude the plugging device 10 from the distal end of the delivery catheter 15. An exemplary pusher member 19 can have an enlarged distal end configured to push the proximal end portion 11 of the wire 12 to move the plugging device 10 from the delivery catheter 15, as shown in FIG. 2. Since the pusher member 19 is not coupled to the plugging device 10, the proximal movement of the pusher member 19 does not cause the plugging device 10 to move in the proximal direction.

[0037] In FIG. 3, the plugging device 10 is shown as having a fully secondary shape, where the upper loop 32 longitudinally overlaps with the adjacent upper loop 32, and the lower loop 34 longitudinally overlaps with the adjacent lower loop 34. However, when in the secondary shape, the upper loop 32 does not overlap with the lower loop 34. As seen in FIG. 3, when in the secondary shape, the longitudinally overlapping configuration of the plugging device 10 defines a series of overlapping figure-eights in the longitudinal direction. When the plugging device 10 is formed from the helical coil 5, the upper loop 32 and the lower loop 34 can each have a second outer diameter D2 that is larger than the first outer diameter D1 shown in FIG. 1B. In some embodiments, as shown in FIG. 3, the second outer diameter D2 of the upper loop 32 may be the same as the second outer diameter D2 of the lower loop 34, and each second outer diameter D2 may be substantially the same. In other embodiments, the upper loop 32 can have an outer shape that is larger than that of the lower loop 34 or an outer diameter that is smaller than that of the lower loop 34. In yet another embodiment, the upper loop 32 and the lower loop 34 can each have different unique outer diameters.

[0038] FIG. 4 shows an alternative embodiment of the occlusion device 100, which includes a proximal region 118 constrained in a primary shape within the delivery catheter 15, a distal region 122 having a secondary shape outside the delivery catheter, and an intermediate region 120 where the occlusion device 100 transitions from the primary shape to the secondary shape as the occlusion device 100 exits the delivery catheter. In some embodiments, the occlusion device 100 can be formed from a single wire 112 such that the entire occlusion device 100 has a monolithic structure. In other embodiments, the occlusion device 100 can be formed from a plurality of wires 112 that form a plurality of secondary shapes. The wire 112 can automatically change from the primary shape to a predetermined secondary shape when the wire is released from the delivery catheter 15. In some embodiments, the wire 112 can be made of a nickel-titanium alloy (e.g., nitinol) that possesses both mechanical shape memory properties and thermal shape memory properties. However, in other embodiments, the wire 112 can be made of any material that exhibits mechanical and / or thermal shape memory properties, or can be made of platinum, a platinum alloy, tungsten, a tungsten alloy, or other similar materials. The wire 112 can be permanently processed into the secondary shape by heat setting or other methods. In some embodiments, the wire 112 can have a circular cross-section with a diameter in the range of 0.05 mm to 0.3 mm.

[0039] The proximal region 118 has a primary shape defined by a plurality of loops 130 in a linearly extended configuration, all of the plurality of loops being longitudinally spaced apart and including a plurality of upper loops 132 extending above the longitudinal axis X'-X' of the plugging device and a plurality of lower loops 134 extending below the longitudinal axis. At least some of the plurality of upper loops 132 and lower loops 134 in the primary shape are closed, and they are defined by the intersections 111 of the wire 112. In the embodiment shown in FIG. 4, all of the plurality of loops 130 forming the plugging device 100 are closed loops in which a first portion of the wire 112 intersects a second portion of the wire 112 at the intersection 111 to form a closed loop 130. In the intermediate region 120, as the plugging device 100 exits the delivery catheter 15, the plurality of upper closed loops 132 move closer to each other longitudinally, and the plurality of lower closed loops 134 move closer to each other longitudinally. As shown in FIG. 4, the secondary shape is formed by upper closed loops 132 and lower closed loops 134 alternately arranged longitudinally. As the plugging device 100 continues to move distally beyond the delivery catheter 15, as shown in the distal region 122, the plurality of upper loops 132 continue to move closer to each other until they overlap each other longitudinally, and the plurality of lower loops 134 continue to move closer to each other until they overlap each other longitudinally.

[0040] In some embodiments, the proximal end and / or region of wire 112 may not have a coupling structure configured to removably engage with a delivery device as described above for the plugging device 10. In some embodiments, the proximal end of wire 112 may be a non-traumatic end that is polished to a rounded shape or melted into a ball shape, similar to the distal tip 14 described above. The plugging device 100 is extruded from the delivery catheter 15 in a one-way deployment. The pusher member 19 can be advanced through the delivery catheter 15 to extrude the plugging device 100 from the distal end of the delivery catheter 15. An exemplary pusher member 19 can have an enlarged distal end configured to push the proximal end of wire 112 to move the plugging device 100 from the delivery catheter 15, as shown in FIG. 4. The pusher member 19 is not coupled to the plugging device 100.

[0041] In FIG. 5, the plugging device 100 is shown as having a fully secondary shape, with the upper closed loop 132 longitudinally overlapping an adjacent upper closed loop 132 and the lower closed loop 134 longitudinally overlapping an adjacent lower closed loop 134. However, when in the secondary shape, the upper closed loop 132 does not overlap the lower closed loop 134. As seen in FIG. 5, when in the secondary shape, the longitudinally overlapping configuration of the plugging device 100 defines a series of longitudinally overlapping figure eights with closed loops. When the plugging device 100 is formed from the helical coil 5, the upper loop 132 and the lower loop 134 can each have a second outer diameter D2' that is larger than the first outer diameter D1 shown in FIG. 1B. In some embodiments, as shown in FIG. 5, the second outer diameter D2' of the upper loop 132 may be the same as the second outer diameter D2' of the lower loop 134, and each second outer diameter D2' may be substantially the same. In other embodiments, the upper loop 132 may have an outer shape that is larger than the lower loop 134 or may have an outer diameter that is smaller than the lower loop 134. In yet another embodiment, the upper loop 132 and the lower loop 134 can each have a different unique outer diameter.

[0042] In some embodiments of the plugging device 10, the proximal end and / or region of the wire 12 may not have any coupling structure configured to removably engage with the delivery device. In some embodiments, the proximal end of the wire 12 can be a non-traumatic end that is polished to a rounded shape or melted into a ball shape, similar to the distal tip 14 described above. The plugging device 10 is extruded from the delivery catheter 15 in a one-way deployment. The pusher member 19 can be advanced through the delivery catheter 15 to extrude the plugging device 10 from the distal end of the delivery catheter 15. An exemplary pusher member 19 can have an enlarged distal end configured to push the proximal end of the wire 12 to move the plugging device 10 from the delivery catheter 15.

[0043] The various components of the plugging devices 10, 100 (and / or other systems or components disclosed herein) for capturing diseased particles, as well as the various materials that can be used for those various elements disclosed herein, can include those commonly associated with medical devices. For the sake of brevity, the plugging device 10 (and variations, systems, or components disclosed herein) has been described, but this is not intended to limit the devices and methods described herein, and this description can be applied to other elements, members, components, or devices disclosed herein.

[0044] In some embodiments, the plugging device 10 (and variations, systems, or components thereof disclosed herein) can be made from metals, metal alloys, ceramics, zirconia, polymers (some examples of which are disclosed below), metal-polymer composites, combinations thereof, or other suitable materials, etc. Some examples of suitable metals and metal alloys include stainless steels such as 444V, 444L, and 314LV stainless steel, mild steel, nickel-titanium alloys such as linear elastic and / or superelastic nitinol, cobalt-chromium alloys, titanium and its alloys, alumina, metals with diamond-like carbon (DLC) or titanium nitride coatings, other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as INCONEL® 625, UNS:N06022 such as HASTELLOY® C-22®, UNS:N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035 such as MP35-N®), nickel-molybdenum alloys (e.g., UNS:N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R44003 such as ELGILOY®, PHYNOX®), platinum-enriched stainless steel, titanium, platinum, palladium, gold, combinations thereof, or any other suitable material.

[0045] As mentioned herein, the family of commercially available nickel-titanium or nitinol alloys includes those that exhibit useful mechanical properties that are chemically similar but different in kind from the conventional shape memory and superelastic types of the class called "linear elastic" or "non-superelastic". Linear elastic and / or non-superelastic nitinol can be distinguished from superelastic nitinol in that it does not exhibit a substantial "superelastic plateau" or "flag region" as shown by superelastic nitinol in its stress / strain curve. Instead, linear elastic and / or non-superelastic nitinol increases stress substantially linearly, or not necessarily completely linearly but somewhat linearly, as recoverable strain increases, until plastic deformation begins, or at least in a more linear relationship than the superelastic plateau and / or flag region seen in superelastic nitinol. Thus, for the purposes of the present disclosure, linear elastic and / or non-superelastic nitinol may also be referred to as "substantially" linear elastic and / or non-superelastic nitinol.

[0046] In some cases, superelastic nitinol can tolerate up to about 8% strain before plastic deformation, whereas linear elastic and / or non-superelastic nitinol can be distinguished from superelastic nitinol in that it can tolerate up to about 2-5% strain while remaining substantially elastic (e.g., before plastic deformation). Both of these materials can be distinguished from other linearly elastic materials, such as stainless steel, which can tolerate only about 0.2-0.44 percent strain before plastic deformation (which can also be distinguished based on its composition).

[0047] In some embodiments, a linear elastic and / or non-superelastic nickel-titanium alloy is an alloy that does not exhibit any martensite / austenite phase change detectable by differential scanning calorimetry (DSC) and dynamic mechanical thermal analysis (DMTA) over a wide temperature range. For example, in some embodiments, a linear elastic and / or non-superelastic nickel-titanium alloy has no martensite / austenite phase change detectable by DSC and DMTA in the range of about -60 degrees Celsius (°C) to about 120 °C. Thus, the mechanical bending properties of such materials may generally be little affected by temperature over this very wide temperature range. In some embodiments, the mechanical bending properties of a linear elastic and / or non-superelastic nickel-titanium alloy at ambient temperature or room temperature are substantially the same as the mechanical properties at body temperature, e.g., in that they do not exhibit a superelastic plateau and / or flag region. For example, a linear elastic and / or non-superelastic nickel-titanium alloy maintains its linear elastic and / or non-superelastic properties and / or characteristics over a wide temperature range.

[0048] In some embodiments, a linear elastic and / or non-superelastic nickel-titanium alloy may be nickel in the range of about 50 to about 60 weight percent, with the balance being essentially titanium. In some embodiments, the composition is nickel in the range of about 54 to about 57 weight percent. An example of a suitable nickel-titanium alloy is the FHP-NT alloy commercially available from Furukawa Techno-Materials Co., Ltd., located in Kanagawa Prefecture, Japan. Other suitable materials include ULTANIUM (trademark), available from Neo-Metrics, and GUM METAL (trademark), available from Toyota. In some other embodiments, superelastic alloys, such as superelastic Nitinol, may be used to achieve the desired properties.

[0049] In at least some embodiments, some or all of the embolization device 10 (and its variations, systems, or components disclosed herein) may be made of, include, or have added thereto a radiopaque material. A radiopaque material is known as a material that can generate a relatively bright image on an X-ray fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image helps the user in determining the location of the embolization device 10 (and its variations, systems, or components disclosed herein). Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials with added radiopaque fillers, and the like. Also, to achieve similar results, other radiopaque marker bands and / or coils may be incorporated into the design of the embolization filter device 200 (and its variations, systems, or components disclosed herein).

[0050] In some embodiments, the plug device 10 (and its variations, systems, or components disclosed herein) and / or a portion thereof may be made of or include a polymer or other suitable material. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether-ester (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester copolymers (e.g., butylene / poly(alkylene ether) phthalate, and / or other polyester elastomers such as HYTREL® available from DuPont), polyamide (e.g., DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamide, block polyamide / ether, polyether block amide (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex® high density polyethylene, Marlex® low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (EMS AmericanGRILAMID® (available from EMS-GRILTECH), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, ionomer, polyurethane silicone copolymer (e.g., Elast-Eon® from AorTech Biomaterials or ChronoSil® from AdvanSource Biomaterials), biocompatible polymers, other suitable materials, mixtures, combinations, and copolymers thereof, polymer / metal composites, etc. may be included. In some embodiments, the sheath is mixable with liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0051] The present disclosure should be understood to be merely exemplary in many respects. Without departing from the scope of the present disclosure, details may be changed, particularly with regard to the shape, size, and arrangement of steps. This may include, within a suitable range, the use of any feature of one exemplary embodiment in other embodiments. The scope of the present disclosure is, of course, defined by the language of the appended claims.

Claims

1. A plugging device configured to be slidably received within a catheter and deployed from the catheter, comprising a single wire having a primary shape when disposed within the catheter and a secondary shape when released from the catheter, wherein the primary shape is defined by a plurality of loops in a linearly extended configuration, all of the plurality of loops being longitudinally spaced apart and including a plurality of upper loops extending above the longitudinal axis of the plugging device and a plurality of lower loops extending below the longitudinal axis, and in the secondary shape, the plurality of upper loops have a configuration in which they overlap longitudinally and the plurality of lower loops have a configuration in which they overlap longitudinally. A plugging device.

2. The plugging device according to claim 1, wherein in the secondary shape, the plurality of upper loops do not overlap with the plurality of lower loops.

3. The plugging device according to claim 1 or 2, wherein the longitudinally overlapping configuration defines a series of figure-eight shapes overlapping longitudinally.

4. The plugging device according to any one of claims 1 to 3, wherein the single wire is a helical coil formed by a plurality of first loops, each of the plurality of first loops having a first outer diameter, and each of the first outer diameters being substantially the same.

5. The plugging device according to claim 4, wherein the plurality of upper loops and the plurality of lower loops each have a second outer diameter larger than the first outer diameter, and each of the second outer diameters is substantially the same.

6. The plugging device according to any one of claims 1 to 5, wherein the secondary shape is formed by upper loops and lower loops alternately arranged longitudinally.

7. The plugging device according to claim 6, wherein at least some of the plurality of loops in the primary shape are open and define a meandering shape.

8. The plugging device according to claim 6, wherein at least some of the plurality of loops in the primary shape are closed.

9. The plugging device according to claim 6, wherein all of the upper loops and the lower loops in the secondary shape are closed.

10. The plugging device according to any one of claims 1 to 9, wherein the single wire automatically changes from the primary shape to the secondary shape when the wire is released from the catheter.

11. The plugging device according to any one of claims 1 to 10, wherein the cross-section of the wire is circular and the diameter of the cross-section is in the range of 0.05 mm to 0.3 mm.

12. The plugging device according to any one of claims 1 to 11, wherein the distal end of the plugging device defines a non-traumatic end and the proximal end of the plugging device does not have a coupling element.

13. The plugging device according to any one of claims 1 to 12, further comprising a plurality of fiber bundles coupled to the wire.

14. A vascular occlusion system, comprising: a catheter having a lumen with a delivery end; a plugging device slidably received within the lumen of the catheter and configured to be deployed from the lumen, wherein the plugging device includes a single wire having a primary shape when disposed within the lumen of the catheter and a secondary shape when released from the delivery end, the primary shape being defined by a plurality of loops in a linearly extended configuration, all of the plurality of loops being longitudinally spaced apart, in the secondary shape, the plurality of loops including a plurality of upper loops and a plurality of lower loops having a configuration that overlaps longitudinally, the longitudinally overlapping configuration defining a series of figure eights that overlap longitudinally.

15. The vascular occlusion system according to claim 14, further comprising a pusher member disposed within the lumen of the catheter, the pusher member having a distal end configured to push the proximal end of the plugging device out of the lumen, and the pusher member and the plugging device not being coupled.

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