Vascular occlusion device

Abstract

A vascular occlusion device includes an embolic device configured to be slidably received within and deployed from a catheter. The embolic device includes a wire having a primary shape when disposed within the catheter and a secondary shape when released from the catheter. The main shape is defined by a plurality of rings in a linearly expanded configuration, wherein all rings of the plurality of rings are longitudinally spaced apart and include an upper ring and a lower ring. In the secondary shape, the upper ring is in a longitudinally overlapping configuration and the lower ring is in a longitudinally overlapping configuration.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 366,914, filed on June 23, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to medical devices and more particularly to vaso-occlusive devices, and methods of using such medical devices. Background Art

[0004] A variety of medical devices have been developed for medical use, including, for example, medical devices for occluding blood vessels in the treatment or prevention of pathological conditions. These medical devices can be used in a variety of blood vessels and are manufactured and used according to any of a variety of different methods. Each of the known medical devices and methods has certain advantages and disadvantages. There is a need to provide alternative medical devices and alternative methods for making and using medical devices. Summary of the invention

[0005] The present invention provides designs, materials, manufacturing methods, and use alternatives for medical devices. An example embolic 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, wherein the primary shape is defined by a plurality of rings in a linearly expanded configuration, wherein all of the plurality of rings are longitudinally spaced apart and include an upper ring extending above a longitudinal axis of the plunger device and a lower ring extending below the longitudinal axis, and wherein in the secondary shape, the upper ring is in a longitudinally overlapping configuration and the lower ring is in a longitudinally overlapping configuration.

[0006] Alternatively or additionally to the above embodiments, in the secondary shape, the upper ring does not overlap the lower ring.

[0007] Alternatively or additionally to any of the above embodiments, the longitudinal overlapping configuration defines a series of longitudinally overlapping figure eights.

[0008] Alternatively or additionally to any of the above embodiments, the single wire is a helical coil of first loops, each of the first loops having a first outer diameter, and each of the first outer diameters are substantially the same.

[0009] Alternatively or additionally to any of the above embodiments, the upper ring and the lower ring each have a second outer diameter greater than the first outer diameter, wherein each of the second outer diameters are substantially the same.

[0010] Alternatively or additionally to any of the above embodiments, the secondary shape is formed by longitudinally alternating upper and lower rings.

[0011] 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 serpentine shape.

[0012] Alternatively or additionally to any of the above embodiments, at least some of the plurality of loops in the primary shape are closed.

[0013] Alternatively or additionally to any of the above embodiments, both the upper and lower loops in the secondary shape are closed.

[0014] 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.

[0015] Alternatively or additionally to any of the above embodiments, the wire is made of Nitinol.

[0016] 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.

[0017] Alternatively or additionally to any of the above embodiments, the distal end of the embolic device defines an atraumatic end and the proximal end of the embolic device is free of any coupling elements.

[0018] Alternatively or additionally to any of the above embodiments, the embolic device further comprises a plurality of fiber bundles coupled to the wire.

[0019] An example vascular occlusion system includes a catheter having a lumen with a delivery end; and an embolic device configured to be slidably received within the catheter and deployed from the catheter, the embolic device comprising a single wire having a primary shape when disposed within the catheter and a secondary shape when released from the delivery end, wherein the primary shape is defined by a plurality of rings in a linearly expanded configuration, wherein all of the plurality of rings are longitudinally spaced apart, and wherein in the secondary shape, the plurality of rings include an upper ring and a lower ring in a longitudinally overlapping configuration.

[0020] Alternatively or additionally to the above embodiments, the longitudinal overlapping configuration is a series of longitudinally overlapping figure-eight shapes.

[0021] Alternatively or additionally to any of the above embodiments, the secondary shape is formed by longitudinally alternating upper and lower rings.

[0022] 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 serpentine shape.

[0023] Alternatively or additionally to any of the above embodiments, at least some of the plurality of loops in the primary shape are closed.

[0024] Another example vascular occlusion system includes a catheter having a lumen with a delivery end; an embolic device configured to be slidably received within the catheter and deployed from the catheter, the embolic device comprising a single wire having a primary shape when disposed within the catheter and a secondary shape when released from the delivery end, the primary shape being defined by a plurality of rings in a linearly expanded configuration, wherein all of the plurality of rings are longitudinally spaced apart, wherein in the secondary shape, the plurality of rings include an upper ring and a lower ring in a longitudinally overlapping configuration; and a pusher member disposed within the lumen, the pusher member having a distal end configured to push a proximal end of the embolic device out of the lumen, wherein the pusher member and the embolic device are not coupled.

[0025] The above summary of some embodiments, aspects and / or examples is not intended to describe every embodiment or every implementation of the present invention. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The present invention may be more fully understood by considering the following detailed description of various embodiments in conjunction with the accompanying drawings, in which:

[0027] Figure 1A is a side view of an example linear wire;

[0028] Figure 1B is a side view of an example coiled wire;

[0029] Figure 2 is a side view of an example embolic device as it exits a delivery catheter and begins to move into a secondary shape, wherein the delivery catheter is shown in a cross-sectional view;

[0030] Figure 3 is in secondary shape Figure 2 Side view of the embolic device;

[0031] Figure 4 is a side view of another example embolic device as it exits a delivery catheter and begins to move into a secondary shape, wherein the delivery catheter is shown in cross-section; and

[0032] Figure 5 is in secondary shape Figure 4 Side view of the embolic device.

[0033] Although the various aspects of the present invention are suitable for various modifications and alternative forms, the specific details thereof have been shown in the drawings by way of example and will be described in more detail. However, it should be understood that it is not intended to limit the various aspects of the present invention to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and substitutes that fall within the spirit and scope of the present invention. DETAILED DESCRIPTION

[0034] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0035] All numerical values ​​are assumed to be modified by the term "about" herein, whether or not explicitly indicated. In the context of numerical values, the term "about" generally refers to a numerical range that is considered by those skilled in the art to be equivalent to the quoted value (e.g., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure. Unless otherwise specified, the term "about" (e.g., in contexts other than numerical values) may be assumed to have its ordinary and customary definition, as understood and consistent with the context of this specification.

[0036] References to numerical ranges expressed by endpoints include all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable sizes, ranges, and / or values ​​are disclosed for various components, features, and / or specifications, those skilled in the art to which the present invention relates will appreciate that desired sizes, ranges, and / or values ​​can be derived from those explicitly disclosed.

[0037] As used in this specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the content clearly indicates otherwise. As used in this specification and the appended claims, the term "or" is generally used in a sense that includes "and / or" unless the content clearly indicates otherwise. It should be noted that, for ease of understanding, certain features of the present invention may be described in the singular, even if those features may be plural or repeated in the disclosed embodiments. Each instance of a feature may include and / or contain a singular disclosure unless expressly indicated to the contrary. For simplicity and clarity, not all elements of the present invention will necessarily be shown in each figure or discussed in detail below. However, it should be understood that unless expressly stated to the contrary, the following discussion may apply equally to any and / or all of the components where there is more than one. Additionally, for clarity, all instances of some elements or features may not be shown in each figure.

[0038] Relative terms, such as "proximal", "distal", "advance", "extraction", variations thereof, etc., may generally be considered with respect to the positioning, orientation, and / or operation of various elements relative to a user / operator / manipulator of the device, with "proximal" and "extraction" meaning or referring to closer to or toward the user and "distal" and "advance" meaning or referring to farther from or away from the user. In some cases, the terms "proximal" and "distal" may be arbitrarily assigned to facilitate understanding of the present invention, and such circumstances will be apparent to the skilled person. Other relative terms, such as "upstream", "downstream", "inflow", and "outflow" refer to the direction of fluid flow in a cavity, such as a body cavity, a blood vessel, or within a device.

[0039] The term "range" may be understood to mean the maximum measure of the dimensions described and identified, unless the range and dimensions in question are preceded by "minimum" or identified as "minimum", which may be understood to mean the minimum measure of the dimensions described and identified. For example, "external range" may be understood to mean the maximum external dimension, "radial range" may be understood to mean the maximum radial dimension, "longitudinal range" may be understood to mean the maximum longitudinal dimension, etc. Each instance of "range" may be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and will become apparent to the skilled person based on the context of individual use. Generally, "range" may be considered to be the maximum possible dimension measured according to the intended use, while "minimum range" may be considered to be the minimum possible dimension measured according to the intended use. In some cases, "range" may generally be measured orthogonally in a plane and / or cross section, but may also be measured differently, such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc., as will be apparent from the particular context. Additionally, when used to refer to two dimensions being "substantially the same", the term "substantially" generally refers to a difference of less than or equal to 5%.

[0040] The terms "integral" and "unitary" shall generally refer to an element or elements that are made or composed of a single structure or base unit / element. Integral and / or unitary elements shall exclude structures and / or features that result from assembling or otherwise combining together multiple discrete elements.

[0041] It should be noted that references to "one embodiment", "some embodiments", "other embodiments", etc. in the specification indicate that the described embodiments may include a particular feature, structure, or characteristic, but each embodiment may not necessarily include the particular feature, structure, or characteristic. In addition, such phrases do not necessarily refer to the same embodiment. In addition, when a particular feature, structure, or characteristic is described in conjunction with an embodiment, it is within the knowledge of a person skilled in the art to affect the particular feature, structure, or characteristic in conjunction with other embodiments, whether or not explicitly described, unless explicitly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a particular combination, can still be considered to be combinable or arranged with each other to form other additional embodiments, or to supplement and / or enrich the described embodiments, as will be understood by a person of ordinary skill in the art.

[0042] For the sake of clarity, certain identifying digital nomenclature (e.g., first, second, third, fourth, etc.) can be used throughout the specification and / or claims to name and / or distinguish various descriptions and / or claimed features. It is to be understood that the digital nomenclature is not intended to be limiting and is merely exemplary. In certain embodiments, for the sake of brevity and clarity, the digital nomenclature previously used can be changed and deviate from. That is, the feature identified as a "first" element can be referred to as a "second" element, a "third" element, etc., later, or can be omitted completely, and / or different features can be referred to as a "first" element. The meaning and / or name in each case will be apparent to the technician.

[0043] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, in which similar elements in different figures have the same numbering. The detailed description and the accompanying drawings are intended to illustrate rather than limit the present invention. Those skilled in the art will recognize that the various elements described and / or shown may be arranged in various combinations and configurations without departing from the scope of the present invention. The detailed description and the accompanying drawings illustrate example embodiments of the present invention. However, for the purpose of clarity and ease of understanding, although each feature and / or element may not be shown in each figure, the features and / or elements may also be understood to be present unless otherwise stated.

[0044] Many diseases or conditions may benefit from vascular occlusion, such as, but not limited to, bleeding, aneurysms, venous insufficiency, cutting off blood flow prior to organ resection, or preventing embolic beads from backflowing into branching vessels in the liver. Embolic devices can be used to close blood vessels and / or fill aneurysm sacs to achieve vascular occlusion.

[0045] In some embodiments, a vascular occlusive device may include an embolic device made of a wire having a primary shape when disposed within a delivery catheter and a secondary shape when released from the delivery catheter. Wire 12 may be a single linear wire piece having a rounded distal tip 14, such as Figure 1A In other embodiments, the wire 12 forming the embolic device may be a single wire that is wound multiple times to form a generally tubular structure, such as a helical coil 5 having a rounded distal tip 14, as shown in FIG. Figure 1B As shown. The helical coil 5 may be formed by a series of continuous loops or windings, the pitch of which is constant or alternatively varies over the length of the helical coil 5. The helical coil 5 may 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, such as Figure 1B In some embodiments, the 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 by the soft wire 12.

[0046] exist Figure 1A and Figure 1B In the two embodiments shown, the wire 12 can be formed with a trauma-free distal tip 14, which prevents the embolic device from causing damage to the patient's vascular system when passing through the patient's vascular system. The distal tip 14 can be the round end of the wire 12. The distal end of the wire 12 can be ground to form a round, smooth end, or it can be heated to form a round end or a ball. In other embodiments, the distal tip 14 can be made of non-radiopaque polypropylene. Alternatively, the distal tip 14 can be used as a distal implant marker, which enables the embolic device to be placed in a suitable position under radiographic observation. In certain embodiments, the distal tip 14 can be made of a radiopaque material, such as a platinum / iridium alloy.

[0047] The wire 12 can be wound to form a primary shape when positioned in and constrained by a delivery catheter, and to form a secondary shape when released from the delivery catheter. The following description will refer to the embolic device 10, 100 made of the wire 12, 112, however, it should be understood that the wire 12, 112 can be as Figure 1A A single linear wire 12 as shown, or Figure 1B A single wire is shown formed into a helical coil 5. In other embodiments, the wire 12 or helical coil 5 may be formed from multiple wires, such as a braid or twisted bundle.

[0048] In some embodiments, multiple thrombogenicity fiber bundles 17 may be attached to the wire 12, 112 or the helical coil 5 at specified intervals to enhance thrombogenicity of the coil, such as Figure 1BTypically, the fiber bundle 17 includes multiple fibers extending from a single attachment point, as shown. However, in some embodiments, a single fiber may constitute the fiber bundle. The fiber bundle 17 may be made of polyethylene terephthalate or nylon. The 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.

[0049] Figure 2 The embolic device 10 is shown, wherein the proximal region 18 is constrained in a primary shape within the lumen of the delivery catheter 15, the distal region 22 is in a secondary shape outside the delivery catheter, and when the embolic device 10 leaves the delivery catheter, the intermediate region 20 is converted from the primary shape to the secondary shape. In some embodiments, the embolic device 10 can be formed by a single wire 12, so that the entire embolic device is a unitary structure. In other embodiments, the embolic device 10 can be formed by a plurality of wires 12 forming a plurality of secondary shapes. When the wire is released from the delivery end of the delivery catheter 15, the wire 12 can automatically move from the primary shape to a predetermined secondary shape. For example, the wire 12 can be made of a nickel-titanium alloy (e.g., Nitinol) having both mechanical and thermal shape memory properties. However, in other embodiments, the wire 12 can be made of any material exhibiting mechanical and / or thermal shape memory properties, or, alternatively, made of platinum, platinum alloy, tungsten, tungsten alloy or other similar materials. The wire 12 may be heat set or otherwise permanently set into a secondary shape so that it freely transitions from the primary shape to the secondary shape when it exits 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.

[0050] exist Figure 2 In the illustrated embodiment, the proximal region 18 has a main shape defined by a plurality of rings 30 in a linearly expanded configuration, wherein all of the rings in the plurality of rings are longitudinally spaced apart. The plurality of rings 30 include an upper ring 32 extending above the longitudinal axis XX of the embolic device 10 and a lower ring 34 extending below the longitudinal axis, such as Figure 2 At least some of the plurality of upper rings 32 and lower rings 34 in the primary shape are open and define a serpentine shape. The serpentine shape is defined by a series of undulating peaks (upper rings 32) and valleys (lower rings 34), as shown in the proximal region 18 and the intermediate region 20. In the intermediate region 20, when the embolic device 10 leaves the delivery catheter 15 and begins to move into the secondary shape, the plurality of upper rings 32 move closer longitudinally and the plurality of lower rings 34 move closer longitudinally. As shown in FIG. Figure 2As shown, the secondary shape is formed by longitudinally alternating upper rings 32 and lower rings 34. As the embolic device 10 continues to move distally beyond the delivery catheter 15, as shown in the distal region 22, the plurality of upper rings 32 continue to move closer to each other until they longitudinally overlap each other, and the plurality of lower rings 34 continue to move closer to each other until they longitudinally overlap each other.

[0051] In some embodiments, the proximal end 11 and / or region of the wire 12 may be free of any coupling structure that is configured to removably engage with a delivery device. The proximal end of the wire 12 may be an atraumatic end that is ground into a round shape or melted into a ball similar to the distal tip 14 described above. The embolic device 10 is pushed out of the delivery catheter 15 in a unidirectional deployment, rather than using a coupling device to deliver the embolic device 10. A pusher member 19 may be advanced through the delivery catheter 15 to push the embolic device 10 out of the distal end of the delivery catheter 15. An example pusher member 19 may have an enlarged distal end that is configured to push the proximal end of the wire 12 to move the embolic device 10 out of the delivery catheter 15, such as Figure 2 The pusher member 19 is not coupled to the embolic device 10, so any proximal movement of the pusher member 19 does not move the embolic device 10 in the proximal direction.

[0052] The embolization device 10 is Figure 3 32 is shown as being completely in the secondary shape, wherein the upper ring 32 longitudinally overlaps the adjacent upper ring 32, and the lower ring 34 longitudinally overlaps the adjacent lower ring 34. However, when in the secondary shape, the upper ring 32 does not overlap the lower ring 34. Figure 3 As seen in FIG. 1 , when in the secondary shape, the longitudinally overlapping configuration of the embolic device 10 defines a series of longitudinally overlapping figure-eight shapes. When the embolic device 10 is formed from a helical coil 5, the upper ring 32 and the lower ring 34 may each have a width greater than Figure 1B In some embodiments, the second outer diameter D2 of the upper ring 32 may be the same as the second outer diameter D2 of the lower ring 34, and each of the second outer diameters D2 may be substantially the same, such as Figure 3 In other embodiments, the upper ring 32 may have a larger or smaller outer diameter than the lower ring 34. In further embodiments, each of the upper ring 32 and the lower ring 34 may have a different, unique outer diameter.

[0053] Figure 4Another embodiment of the embolic device 10 is shown, wherein the proximal region 118 is constrained in a primary shape within the delivery catheter 15, the distal region 122 is in a secondary shape outside the delivery catheter, and when it leaves the delivery catheter, the intermediate region 120 is converted from the primary shape to the secondary shape. In some embodiments, the embolic device 100 can be formed by a single wire 112, so that the entire embolic device 100 is a unitary structure. In other embodiments, the embolic device 100 can be formed by a plurality of wires 112 forming a plurality of secondary shapes. When the wire is released from the delivery catheter 15, the wire 112 can automatically move from the primary shape to a predetermined secondary shape. In some embodiments, the wire 112 can be made of a nickel-titanium alloy (e.g., Nitinol) having both mechanical and thermal shape memory properties. However, in other embodiments, the wire 112 can be made of any material exhibiting mechanical and / or thermal shape memory properties, or, alternatively, made of platinum, platinum alloy, tungsten, tungsten alloy or other similar materials. The wire 112 may be heat set or otherwise permanently set into the secondary shape. In some embodiments, the wire 112 may have a circular cross-section with a diameter in the range of 0.05 mm to 0.3 mm.

[0054] The proximal region 118 has a main shape defined by a plurality of rings 130 in a linearly expanded configuration, wherein all of the plurality of rings are longitudinally spaced apart and include an upper ring 132 extending above the longitudinal axis X'-X' of the plunger device and a lower ring 134 extending below the longitudinal axis. At least some of the plurality of upper rings 132 and lower rings 134 in the main shape are closed and defined by the intersection 111 of the wire 112. Figure 4 In the illustrated embodiment, all of the loops 130 forming the embolic device 100 are closed loops, wherein the first portion of the wire 112 crosses over the second portion of the wire 112 at the intersection 111 to form the closed loops 130. In the intermediate region 120, when the embolic device 100 leaves the delivery catheter 15, the plurality of upper closed loops 132 move closer longitudinally, and the lower closed loops 134 move closer longitudinally. Figure 4 As shown, the secondary shape is formed by longitudinally alternating upper closed rings 132 and lower closed rings 134. As the embolic device 100 continues to move distally beyond the delivery catheter 15, as shown in the distal region 122, the plurality of upper rings 132 continue to move closer to each other until they longitudinally overlap each other, and the plurality of lower rings 134 continue to move closer to each other until they longitudinally overlap each other.

[0055] In some embodiments, the proximal end and / or region of the wire 112 may be free of any coupling structure that is configured to removably engage with a delivery device, as described above with respect to the coupling device 10. In some embodiments, the proximal end of the wire 112 may be an atraumatic end that is rounded or melted into a ball similar to the distal tip 14 described above. Instead, the embolic device 100 is pushed out of the delivery catheter 15 in a unidirectional deployment. The pusher member 19 may be advanced through the delivery catheter 15 to push the embolic device 100 out of the distal end of the delivery catheter 15. Example pusher member 19 may have an enlarged distal end that is configured to push the proximal end of the wire 112 to move the embolic device 100 out of the delivery catheter 15, as Figure 4 The pusher member 19 is not coupled to the occluding device 100 .

[0056] The embolization device 100 is Figure 5 134 is shown as being completely in the secondary shape, wherein the upper closed loop 132 longitudinally overlaps the adjacent upper closed loop 132, and the lower closed loop 134 longitudinally overlaps the adjacent lower closed loop 134. However, when in the secondary shape, the upper closed loop 132 does not overlap the lower closed loop 134. Figure 5 As seen in FIG. 1 , when in the secondary shape, the longitudinally overlapping configuration of the embolic device 100 defines a series of longitudinally overlapping figure-eight shapes. When the embolic device 100 is formed from a helical coil 5, the upper ring 132 and the lower ring 134 may each have a width greater than 100 mm. Figure 1B In some embodiments, the second outer diameter D2 of the upper ring 132 may be the same as the second outer diameter D2 of the lower ring 134, and each of the second outer diameters D2 may be substantially the same, such as Figure 5 In other embodiments, the upper ring 132 may have a larger or smaller outer diameter than the lower ring 134. In further embodiments, each of the upper ring 132 and the lower ring 134 may have a different, unique outer diameter.

[0057] In some embodiments of the embolic device 10, the proximal end and / or region of the wire 12 may not have any coupling structure, which is configured to be removably engaged with the delivery device. In some embodiments, the proximal end of the wire 12 may be an atraumatic end that is ground into a round shape or melted into a ball similar to the distal tip 14 described above. Conversely, the embolic device 10 is pushed out of the delivery catheter 15 with a unidirectional deployment. The pusher member 19 can be pushed through the delivery catheter 15 to push the embolic device 10 out of the distal end of the delivery catheter 15. The example pusher member 19 can have an enlarged distal end that is configured to push the proximal end of the wire 12 to move the embolic device 10 out of the delivery catheter 15.

[0058] The materials of various components and various elements thereof that can be used for the embolic devices 10, 100 (and / or other systems or components disclosed herein) for capturing lesion particles disclosed herein may include those commonly associated with medical devices. For simplicity, the following discussion refers to the embolic device 10 (and variations, systems or components disclosed herein). However, this is not intended to limit the devices and methods described herein, as the discussion can be applied to other elements, components, parts or devices disclosed herein.

[0059] In some embodiments, the embolic device 10 (and variations, systems, or components thereof disclosed herein) can be made of metals, metal alloys, ceramics, zirconium oxide, polymers (some examples of which are disclosed below), metal-polymer composites, combinations thereof, or the like, or other suitable materials. Some examples of suitable metals and metal alloys include stainless steels, such as 444V, 444L, and 314LV stainless steels; low carbon steels; nickel-titanium alloys, such as linear elastic and / or superelastic nitinol; cobalt-chromium alloys, titanium and its alloys, aluminum oxide, metals with diamond-like coatings (DLC) or titanium nitride coatings, other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as 625, UNS:N06022, such as UNS:N10276, such as other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, such as etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as ALLOY ), 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, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such as etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; etc.; or any other suitable material.

[0060] As mentioned herein, within the family of commercially available nickel-titanium or Nitinol alloys, there is a class designated as "linear elastic" or "non-superelastic," which, while chemically similar to traditional shape memory and superelastic classes, may also exhibit different and useful mechanical properties. Linear elastic and / or non-superelastic Nitinol may be distinguished from superelastic Nitinol in that linear elastic and / or non-superelastic Nitinol does not display a significant "superelastic plateau" or "flag region" in its stress / strain curve as superelastic Nitinol does. In contrast, in linear elastic and / or non-superelastic Nitinol, as recoverable strain increases, stress continues to increase in a substantially linear or somewhat, but not necessarily completely, linear relationship until plastic deformation begins or at least proceeds in a more linear relationship than the superelastic plateau and / or flag region that may be seen with superelastic Nitinol. Therefore, for purposes of the present invention, linear elastic and / or non-superelastic Nitinol may also be referred to as "substantially" linear elastic and / or non-superelastic Nitinol.

[0061] In some cases, linear elastic and / or non-superelastic Nitinol can also be distinguished from superelastic Nitinol because linear elastic and / or non-superelastic Nitinol can accept strains up to about 2-5% while remaining substantially elastic (e.g., before plastic deformation), while superelastic Nitinol can accept strains up to about 8% before plastic deformation. These two materials can be distinguished from other linear elastic materials, such as stainless steel, which can only accept strains of about 0.2 to 0.44% before plastic deformation (which can also be distinguished based on their composition).

[0062] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy is an alloy that does not show any martensite / austenite phase transformation detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) over a wide temperature range. For example, in some embodiments, in a linear elastic and / or non-superelastic nickel-titanium alloy, there may be no martensite / austenite phase transformation detectable by DSC and DMTA analysis in the range of about -60 degrees Celsius (°C) to about 120°C. Therefore, the mechanical bending properties of this material are generally inert to temperature effects over this wide temperature range. In some embodiments, the mechanical bending properties of the linear elastic and / or non-superelastic nickel-titanium alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature, for example, it does not show a superelastic plateau and / or signature zone. For example, over a wide temperature range, the linear elastic and / or non-superelastic nickel-titanium alloy maintains its linear elastic and / or non-superelastic properties and / or properties.

[0063] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may contain nickel in the range of about 50 to about 60 weight percent, with the remainder being substantially titanium. In some embodiments, the composition contains nickel in the range of about 54 to about 57 weight percent. An example of a suitable nickel-titanium alloy is FHP-NT alloy commercially available from Furukawa TechnoMaterial Co. of Kanagawa, Japan. Other suitable materials may include ULTANIUM TM (available from Neo-Metrics) and GUM METAL TM (Available from Toyota.) In some other embodiments, superelastic alloys, such as superelastic Nitinol, may be used to achieve the desired properties.

[0064] In at least some embodiments, part or all of the embolic device 10 (and variations, systems, or components thereof disclosed herein) may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be capable of producing a relatively bright image on a fluoroscopic screen or with another imaging technique during a medical procedure. This relatively bright image helps the user determine the position of the embolic device 10 (and variations, systems, or components thereof disclosed herein). Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils may also be incorporated into the design of the embolic filtering device 200 (and variations, systems, or components thereof disclosed herein) to achieve the same results.

[0065] In some embodiments, the embolic device 10 (and variations, systems, or components thereof disclosed herein) and / or portions thereof may be made of or include a polymer or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxyethylene (POM, e.g., commercially available from DuPont), polyoxyethylene (POM ... ), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., commercially available from DSM Engineering Plastics ), ether- or ester-based copolymers (e.g., butylene phthalate / poly(alkylene ether) and / or other polyester elastomers such as those commercially available from DuPont ), polyamide (for example, commercially available from Bayer or commercially available from Elf Atochem ), elastomeric polyamides, block polyamide / ether, polyether block amide (PEBA, for example, available under the trade name Commercially available), ethylene-vinyl acetate copolymer (EVA), silicone, polyethylene (PE), High density polyethylene, Low-density polyethylene, linear low-density polyethylene (e.g. ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfone, nylon, nylon-12 (such as commercially available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, polyurethane silicone copolymers (e.g., Aortech Biomaterials' or AdvanSource Biomaterials ), biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the sheath can be mixed with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0066] It should be understood that the present invention is in many respects merely illustrative. Changes may be made in details, particularly in matters of arrangement of shape, size and steps, without exceeding the scope of the present invention. To the extent appropriate, this may include using any of the features of an example embodiment used in other embodiments. Of course, the scope of the present invention is defined by the language of the appended claims.

Claims

1. An embolic device configured to be slidably received within and deployed from a catheter, the embolic device comprising a single wire having a primary shape when disposed within the catheter and a secondary shape when released from the catheter; in, the primary shape being defined by a plurality of rings in a linearly expanded configuration, wherein all of the rings in the plurality of rings are longitudinally spaced apart and include an upper ring extending above a longitudinal axis of the plunger device and a lower ring extending below the longitudinal axis; as well as Wherein, in the secondary shape, the upper ring is in a longitudinal overlapping configuration and the lower ring is in a longitudinal overlapping configuration.

2. The occluding device of claim 1, wherein in the secondary shape, the upper ring does not overlap the lower ring.

3. The occlusive device according to one of claims 1 or 2, wherein the longitudinal overlapping formation defines a series of longitudinally overlapping figure-eight shapes.

4. The embolic device of any one of claims 1 to 3, wherein the single wire is a helical coil of first loops, each of the first loops having a first outer diameter, and each of the first outer diameters are substantially the same.

5. The occluding device of claim 4, wherein the upper ring and the lower ring each have a second outer diameter greater than the first outer diameter, wherein each of the second outer diameters is substantially the same.

6. The occlusive device according to any one of claims 1 to 5, wherein the secondary shape is formed by longitudinally alternating upper and lower rings.

7. The occlusive device of claim 6, wherein at least some of the plurality of loops in the primary shape are open and define a serpentine shape.

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

9. The occluding device of claim 6, wherein the upper and lower rings in the secondary shape are both closed.

10. The occluding 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 embolic device according to claim 1 , 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 occluding device according to any one of claims 1 to 11, wherein the distal end of the occluding device defines an atraumatic end and the proximal end of the occluding device is free of any coupling elements.

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

14. A vascular occlusion system comprising: a catheter having a lumen with a delivery end; as well as an embolic device configured to be slidably received within and deployed from the lumen of the catheter, the embolic device comprising: 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; wherein the primary shape is defined by a plurality of rings in a linearly expanded configuration, wherein all rings in the plurality of rings are longitudinally spaced apart; Wherein in the secondary shape, the plurality of rings include an upper ring and a lower ring in a longitudinally overlapping configuration, the longitudinally overlapping configuration defining a series of longitudinally overlapping figure-eight shapes.

15. The vascular occlusive system of claim 14, further comprising a pusher member disposed within the lumen of the catheter, the pusher member having a distal end configured to push a proximal end of the embolic device out of the lumen, wherein the pusher member and the embolic device are not coupled.

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