Embolic device with improved necking coverage - Patents.com

Abstract

To provide an embolic device for treating aneurysms or other vascular disorders that exhibits improved filling and / or neck blockage over conventional devices.SOLUTION: As one example, the embolic device can include a structure that is wound into a spiral shape. In some cases, the spirally wound embolic device includes alternating narrow portions and link portions. As another example, the embolic device can be formed from a structure wound to form an infinity shape or, in some cases, multiple infinity shapes. In instances with multiple infinity shapes, the infinity shapes can be arranged either parallel or perpendicularly to each other. In certain aspects, the embolic device can include two different embolic devices that are attached by an interconnect element, such that the two devices are attached but have independent freedom of motion when placed within a vascular disorder.SELECTED DRAWING: Figure 11A

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to and benefit of U.S. Provisional Patent Application No. 62 / 652,441, filed April 4, 2018, which is incorporated by reference in its entirety.

[0002] In general, various embodiments of the present invention relate to embolic devices for use in the minimally invasive treatment of aneurysms and other vascular defects, and more particularly, to embolic devices that may be shaped and / or configured to achieve improved filling and / or coverage of narrowed portions of vascular defects. [Background technology]

[0003] Generally, an aneurysm is a swelling or bulge that forms a cavity in the wall of a blood vessel. One type of aneurysm is a cerebral aneurysm, which forms in an artery of the brain. A cerebral aneurysm may develop suddenly without early symptoms and may cause significant pain. Generally, in 15% of cerebral aneurysm cases, the patient dies suddenly upon the development of a cerebral aneurysm, in another 15% of cerebral aneurysm cases, the patient dies under medical treatment, and in 30% of cerebral aneurysm cases, the patient survives after treatment but suffers from acute sequelae. Thus, a cerebral aneurysm (or any aneurysm) is a very concerning development.

[0004] Treatment of aneurysms and other similar vascular defects often involves placement of a microcoil within the cavity formed by the aneurysm or defect. Doing so can clot the blood, preventing additional inflow of blood and reducing the risk of the aneurysm or defect rupturing (i.e., embolism). To be effective, embolic microcoils must apply an amount of pressure that is sufficient to prevent additional inflow of blood, but not excessive pressure that would cause rupture.

[0005] An important feature of an embolic device is its ability to block the aneurysm's constriction, i.e., the opening where the aneurysm abuts the blood vessel. Such blockage is important to ensure that excessive amounts of blood do not flow into the aneurysm and expose it to the risk of further bulging or rupture. Previous approaches to block the aneurysm constriction include covering the constriction with a stent-like or braided structure. While these approaches are sometimes effective, there is still opportunity for improvement.

[0006] Thus, a need exists for improved embolic devices that achieve improved filling and / or obliteration of the narrowed portion of an aneurysm. Summary of the Invention [Means for solving the problem]

[0007] In various embodiments, the present invention relates to an improved embolic device that achieves improved filling and necking blockage over conventional devices. In particular, the device can be formed into the shapes of the present invention, which have been observed to improve necking blockage. Exemplary shapes include a spiral shape and an infinity shape, as described in more detail below.

[0008] In addition, one factor that has been found to contribute significantly to unsatisfactory neck blockage in conventional devices is that the portion of the embolic device placed within the aneurysm often shifts or moves while finding equilibrium within the aneurysm. This can occur, for example, when the aneurysm has a complex shape (e.g., bifurcated, bilobed, etc.) and the portion of the embolic device within the aneurysm expands to contact a portion of the interior surface of the aneurysm. Movement of the portion of the device within the aneurysm can cause an associated shift / movement of the portion of the embolic device blocking the neck, which can compromise the blockage. Thus, in some aspects, the invention described herein includes an embolic device that includes two therapeutic elements, one for placement within the aneurysm and another for blocking the neck. The two therapeutic elements can be attached with an interconnecting element that allows the therapeutic elements to have independent degrees of freedom of movement when delivered to the aneurysm.

[0009] In general, in one aspect, embodiments of the invention feature an embolic device for use in treating a vascular disorder. The embolic device can include a flexible structure including a series of alternating narrowed and connecting portions, each connecting portion surrounding at least one in-plane opening. The structure can be adapted to form a spiral shape when unconstrained.

[0010] In various embodiments, the structure can include a coil, a flat sheet, a thin film, and / or combinations thereof. The structure can include materials including platinum, nitinol, alloys thereof, and / or combinations thereof. In some cases, the structure can include a thickness in the range of 0.0005 inches to 0.027 inches. In some cases, each narrow portion includes a helically wound coil and each link portion includes a flat sheet and / or a thin film. At least a portion of the embolic device can be radiopaque. Each narrow portion can be fixedly attached to an adjacent link portion. In some cases, the embolic device can include a strain relief element (e.g., molten suture material, molten polymer, etc.) between each narrow portion and an adjacent link portion. In some cases, each link portion includes a diamond-shaped configuration.

[0011] In various embodiments, each linking portion is adapted to compress when the embolic device is positioned within the microcatheter. Each linking portion can be further adapted to expand upon deployment of the embolic device from the microcatheter. In some cases, the narrowed portions and linking portions alternate at consistent intervals. In other cases, the narrowed portions and linking portions alternate at inconsistent intervals. The embolic device can include a covering element disposed over the structure. The embolic device can include an interconnecting element disposed at an end of the embolic device for attaching the embolic device to one or more different embolic devices (e.g., in series).

[0012] In general, in another aspect, embodiments of the invention feature an embolic device for use in treating another vascular disorder. The embolic device can include a flexible structure adapted to form at least one infinitely shaped portion when unconstrained. The infinitely shaped portion can include two adjacent loops that intersect at a single point.

[0013] In various embodiments, the structure includes a coil, a flat sheet, a thin film, and / or a combination thereof. The structure can include materials including platinum, nitinol, alloys thereof, and / or combinations thereof. In some cases, the structure includes a thickness in the range of 0.0005 inches to 0.027 inches. In some cases, the flexible structure forms at least two infinite shaped portions. At least two of the infinite shaped portions can be arranged to match and cover each other, and / or the at least two infinite shaped portions can be arranged circumferentially around the interior of the vascular defect. At least one infinite shaped portion can be rotated to be perpendicular to another infinite shaped portion. The embolic device can include a covering element disposed over the structure. The embolic device can include an interconnecting element disposed at an end of the embolic device for attaching the embolic device to one or more different embolic devices (e.g., in series).

[0014] In general, in yet another aspect, embodiments of the invention feature a multi-stage embolic device for use in treating a vascular disorder. The multi-stage embolic device can include a first embolic device, a second embolic device different from the first embolic device, and an interconnecting element that joins the first and second embolic devices and allows independent freedom of movement between the first and second embolic devices while the rest are joined together.

[0015] In various embodiments, the first embolic device includes a framework device and the second embolic device includes a filling device. In some cases, upon deployment of the multi-stage embolic device into the vascular defect, the first embolic device is adapted to block a narrowed portion of the vascular defect and the second embolic device is adapted to occupy an interior of the vascular defect. The first embolic device and / or the second embolic device can include a coil, a flat sheet, a thin film, and / or combinations thereof. The first embolic device and / or the second embolic device can include platinum, nitinol, alloys thereof, and / or combinations thereof. In some cases, the first embolic device and / or the second embolic device includes a thickness in the range of 0.0005 inches to 0.027 inches. In some cases, the first embolic device and / or the second embolic device is adapted to form a spiral shape when unconstrained. The interconnecting element can include linked loops and / or nitinol coils. The multi-stage embolic device may further include at least one additional embolic device different from each of the first and second embolic devices, and at least one additional interconnecting element that directly and / or indirectly joins the second and additional embolic devices. The additional interconnecting element allows independent freedom of movement between the second and additional embolic devices while the rest are joined together. The multi-stage embolic device may include a cover element disposed over the first and / or second embolic devices.

[0016] In general, in yet another aspect, embodiments of the invention feature a method for treating a vascular defect. The method can include delivering a multi-stage embolic device to the vascular defect. The multi-stage embolic device can include a first embolic device, a second embolic device different from the first embolic device, and an interconnecting element that joins the first and second embolic devices and allows independent freedom of movement between the first and second embolic devices while the remainder are joined together. The method can further include placing the second embolic device within an interior of the vascular defect and placing the first embolic device to block a narrowed portion of the vascular defect.

[0017] In various embodiments, one of the first and second embolic devices includes a framework device and the other embolic device includes a filling device. The first and / or second embolic devices can include coils, flat sheets, thin films, and / or combinations thereof. The first and / or second embolic devices can include platinum, nitinol, alloys thereof, and / or combinations thereof. In some cases, the first and / or second embolic devices include a thickness in the range of 0.0005 inches to 0.027 inches. In some cases, the first and / or second embolic devices form a spiral shape when unconstrained. The interconnecting elements can include linked loops and / or nitinol coils. The multi-stage embolic device may further include at least one additional embolic device different from each of the first and second embolic devices, and at least one additional interconnecting element that directly and / or indirectly joins the second and additional embolic devices. The additional interconnecting element allows independent freedom of movement between the second and additional embolic devices while the rest are joined together, and the method may further include disposing the additional embolic device within the interior of the vascular defect. The multi-stage embolic device may include a covering element disposed over the first and / or second embolic devices.

[0018] These and other objects, together with advantages and features of the embodiments of the invention disclosed herein, will become more apparent through reference to the following description, the accompanying drawings, and the claims. Moreover, it should be understood that the features of the various embodiments described herein are not mutually exclusive and can exist in various combinations and permutations. The present invention provides, for example, the following: (Item 1) 1. An embolic device for use in treating a vascular disorder, the embolic device comprising: A flexible structure comprising a series of alternating narrowed portions and connecting portions, each connecting portion surrounding at least one in-plane opening. Equipped with An embolic device, wherein the structure is adapted to form a spiral shape when unconstrained. (Item 2) Item 1, wherein the structure comprises at least one of a coil, a flat sheet, a thin film, and combinations thereof. (Item 3) Item 10. The embolic device of item 1, wherein the structure comprises a material selected from the group consisting of platinum, nitinol, alloys thereof, and combinations thereof. (Item 4) Item 1. The embolic device of item 1, wherein the structure has a thickness within the range of 0.0005 inches to 0.027 inches. (Item 5) 2. The embolic device of item 1, wherein each narrowed portion comprises a helically wound coil and each connecting portion comprises at least one of a flat sheet and a thin film. (Item 6) Item 1, wherein at least a portion of the embolic device is radiopaque. (Item 7) Each narrow portion is fixedly attached to an adjacent connecting portion; 2. The embolic device of item 1, further comprising a strain relief element between each narrowed portion and the adjacent connecting portion. (Item 8) 8. The embolic device of claim 7, wherein the strain relief element is formed from at least one of a molten suture material and a molten polymer. (Item 9) 2. The embolic device of item 1, wherein each linking portion has a diamond-shaped configuration. (Item 10) 2. The embolic device of item 1, wherein each linkage portion is adapted to compress when the embolic device is positioned within a microcatheter. (Item 11) 11. The embolic device of claim 10, wherein each linkage portion is further adapted to expand upon deployment of the embolic device from the microcatheter. (Item 12) 2. The embolic device of item 1, wherein the narrowed portions and the connecting portions alternate at consistent intervals. (Item 13) 2. The embolic device of item 1, wherein the narrowed portions and the connecting portions alternate at inconsistent intervals. (Item 14) Item 1 , the embolic device further comprising a cover element disposed over the structure. (Item 15) Item 1, the embolic device further comprising an interconnection element disposed at an end of the embolic device for attaching the embolic device to one or more different embolic devices. (Item 16) Item 16. The embolic device of item 15, wherein the embolic device and the one or more different embolic devices are attached in series. (Item 17) 1. An embolic device for use in treating a vascular disorder, the embolic device comprising: A flexible structure, the flexible structure adapted to form at least one infinitely shaped portion when unconstrained. Equipped with An embolic device, wherein the infinitely shaped portion comprises two adjacent loops that intersect at a single point. (Item 18) Item 18. The embolic device of item 17, wherein the structure comprises at least one of a coil, a flat sheet, a thin film, and combinations thereof. (Item 19) Item 18. The embolic device of item 17, wherein the structure comprises a material selected from the group consisting of platinum, nitinol, alloys thereof, and combinations thereof. (Item 20) Item 18. The embolic device of item 17, wherein the structure has a thickness in the range of 0.0005 inches to 0.027 inches. (Item 21) Item 18. The embolic device of item 17, wherein the structure forms at least two infinity shaped portions. (Item 22) 22. The embolic device according to item 21, wherein at least two of the infinitely shaped portions are arranged to align and cover each other. (Item 23) 22. The embolic device of claim 21, wherein at least one of the infinity shaped portions is rotated so as to be perpendicular to another infinity shaped portion. (Item 24) 22. The embolic device according to item 21, wherein the at least two infinity shaped portions are adapted to be arranged circumferentially around an interior of the vascular defect. (Item 25) Item 18. The embolic device of item 17, further comprising a cover element disposed over the structure. (Item 26) Item 18. The embolic device of item 17, further comprising an interconnection element disposed on an end of the embolic device for attaching the embolic device to one or more different embolic devices. (Item 27) Item 27. The embolic device of item 26, wherein the embolic device and the one or more different embolic devices are attached in series. (Item 28) 1. A multi-stage embolic device for use in treating a vascular disorder, the multi-stage embolic device comprising: a first embolic device; a second embolic device different from the first embolic device; and an interconnection element that joins the first and second embolic devices and allows independent freedom of movement between the first and second embolic devices while remaining joined together; A multi-stage embolization device comprising: (Item 29) 30. The multi-stage embolic device of claim 28, wherein the first embolic device comprises a framework device and the second embolic device comprises a filling device. (Item 30) 29. The multi-stage embolic device of claim 28, wherein upon deployment of the multi-stage embolic device into the vascular defect, the first embolic device is adapted to block a narrowed portion of the vascular defect and the second embolic device is adapted to occupy an interior of the vascular defect. (Item 31) Item 10. The multi-stage embolic device of item 0, wherein at least one of the first and second embolic devices comprises at least one of a coil, a flat sheet, a thin film, and combinations thereof. (Item 32) 30. The multi-stage embolic device of item 28, wherein at least one of the first and second embolic devices comprises a material selected from the group consisting of platinum, nitinol, alloys thereof, and combinations thereof. (Item 33) 30. The multi-stage embolic device of claim 28, wherein at least one of the first and second embolic devices comprises a thickness within the range of 0.0005 inches to 0.027 inches. (Item 34) 30. The multi-stage embolic device according to item 28, wherein at least one of the first and second embolic devices is adapted to form a spiral shape when unconstrained. (Item 35) 30. The multi-stage embolic device of claim 28, wherein the interconnection elements comprise at least one of linked loops or nitinol coils. (Item 36) at least one additional embolic device different from each of the first embolic device and the second embolic device; at least one additional interconnection element that couples, at least one of directly and indirectly, the second embolic device and the additional embolic device and allows independent degrees of freedom of movement between the second embolic device and the additional embolic device while the rest are coupled together; 30. The multi-stage embolic device of item 28, further comprising: (Item 37) 30. The multi-stage embolic device of claim 28, further comprising a covering element disposed over at least one of the first and second embolic devices. (Item 38) 1. A method for treating a vascular disorder, the method comprising: Delivering a multi-stage embolic device to the vascular defect, the multi-stage embolic device comprising: a first embolic device; a second embolic device different from the first embolic device; and an interconnection element that joins the first and second embolic devices and allows independent freedom of movement between the first and second embolic devices while remaining joined together; and placing the second embolic device within the vascular defect; deploying the first embolic device to block a narrowed portion of the vascular defect; A method comprising: (Item 39) Item 39. The method of item 38, wherein one of the first and second embolic devices comprises a framework device and the other embolic device comprises a filling device. (Item 40) Item 39. The method of item 38, wherein at least one of the first and second embolic devices comprises at least one of a coil, a flat sheet, a thin film, and combinations thereof. (Item 41) 40. The method of claim 38, wherein at least one of the first and second embolic devices comprises a material selected from the group consisting of platinum, nitinol, alloys thereof, and / or combinations thereof. (Item 42) Item 39. The method of item 38, wherein at least one of the first and second embolic devices comprises a thickness within the range of 0.0005 inches to 0.027 inches. (Item 43) Item 39. The method of item 38, wherein at least one of the first and second embolic devices forms a spiral shape when unconstrained. (Item 44) Item 39. The method of item 38, wherein the interconnection elements comprise at least one of linked loops or Nitinol coils. (Item 45) The multi-stage embolization device further comprises: at least one additional embolic device different from each of the first embolic device and the second embolic device; at least one additional interconnection element that couples, at least one of directly and indirectly, the second embolic device and the additional embolic device and allows independent degrees of freedom of movement between the second embolic device and the additional embolic device while the rest are coupled together; Equipped with 40. The method of claim 38, further comprising placing the at least one additional embolic device within the vascular defect. (Item 46) 40. The method of claim 38, wherein the multi-stage embolic device further comprises a covering element disposed over at least one of the first embolic device and the second embolic device. [Brief description of the drawings]

[0019] In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the invention are described with reference to the following drawings, in which:

[0020] [Figure 1] FIG. 1 is a schematic perspective view of an embolic device having a spiral shape positioned within an aneurysm, according to one embodiment of the present invention.

[0021] [Diagram 2] FIG. 2 is a schematic perspective view of a coil formed from a spirally wound wire for use in various embodiments of the present invention.

[0022] [Diagram 3] FIG. 3 is a schematic perspective view of an embolic device having a generally spherical spiral shape, in accordance with one embodiment of the present invention.

[0023] [Figure 4A] FIG. 4A is a schematic perspective view showing exemplary dimensions of an embolic device having a generally spherical spiral shape, according to one embodiment of the present invention.

[0024] [Figure 4B] FIG. 4B is a schematic side view showing exemplary dimensions of an embolic device having a generally spherical spiral shape, in accordance with one embodiment of the present invention.

[0025] [Figure 4C]FIG. 4C is a schematic top view illustrating exemplary dimensions of an embolic device having a generally spherical spiral shape, in accordance with one embodiment of the present invention.

[0026] [Figure 5A] FIG. 5A is a schematic top view of an embolic device formed from a flat sheet of material having a constant width, according to one embodiment of the present invention.

[0027] [Figure 5B] FIG. 5B is a schematic top view of an embolic device formed from a flat sheet of material having a draft-like width, according to one embodiment of the present invention.

[0028] [Figure 6] FIG. 6 is a schematic top view of an embolic device formed from two spiral sections connected at a connection region, according to one embodiment of the present invention.

[0029] [Figure 7] FIG. 7 is a schematic top view of an embolic device having a narrowed portion and a connecting portion, in accordance with one embodiment of the present invention.

[0030] [Figure 8] FIG. 8 is a photograph of an embolic device having a narrowed portion and a connecting portion formed from coil sections, according to one embodiment of the present invention.

[0031] [Figure 9A] FIG. 9A is a schematic top view of an embolic device forming a vertical infinity shaped portion, according to one embodiment of the present invention.

[0032] [Figure 9B] FIG. 9B is a schematic perspective view of an embolic device forming a vertical infinity shaped portion dispersed within an aneurysm, according to one embodiment of the present invention.

[0033] [Figure 9C]FIG. 9C is a schematic perspective view of an embolic device forming multiple infinity shaped sections arranged around the inner circumference of the aneurysm, according to one embodiment of the present invention.

[0034] [Figure 10] FIG. 10 is a schematic perspective view of a multi-stage embolic device including two embolic devices joined by an interconnecting element, according to one embodiment of the present invention.

[0035] [Figure 11A] 11A-C are photographs showing an interconnection element joining two embolic devices according to one embodiment of the present invention. [Figure 11B] 11A-C are photographs showing an interconnection element joining two embolic devices according to one embodiment of the present invention. [Figure 11C] 11A-C are photographs showing an interconnection element joining two embolic devices according to one embodiment of the present invention.

[0036] [Figure 12] FIG. 12 is a photograph showing a multi-stage embolic device deployed within a model aneurysm, according to one embodiment of the present invention.

[0037] [Figure 13] FIG. 13 is a photograph showing three embolic devices joined by two interconnecting elements, according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0038] Embodiments of the present invention are directed to improved designs for embolic devices and methods of using the improved devices. Neck blockage is an important feature for embolic devices because it determines the amount of fluid that can pass through the embolic device and into an aneurysm, which directly affects how effective the embolic device is in treating a vascular disorder. Embodiments of the present invention include embolic devices having shapes and / or configurations that achieve improved neck blockage and other performance parameters over conventional devices.

[0039] Generally, all of the embolic devices described herein can take any known form, such as a microcoil (e.g., a bare platinum coil), a flat sheet, a thin film, a combination thereof, etc., although in some cases, a particular device may be described herein as having only one of these forms. In addition, all of the embolic devices described herein can be formed from any suitable material, such as a shape memory material (e.g., Nitinol), platinum, a combination thereof, etc., although in some cases, a particular device may be described herein as having only one of these materials. Furthermore, in various cases, all of the embolic devices described herein can include a structure (e.g., a microcoil, a flat sheet, a thin film, etc.) that is covered by a covering element, as described, for example, in U.S. Patent Publication No. US-2016-0022275-A1, which is incorporated herein by reference in its entirety.

[0040] In various embodiments of the present invention, the embolic device is formed from a structure. For example, as shown in FIG. 1, the embolic device 100 may be adapted to form a spiral shape upon deployment into an aneurysm 104 (reference number 104 may also be applied to any other vascular defect or similar anatomical structure). As used herein, the shape of the embolic device 100 refers to the macro shape formed by the embolic device 100 itself (or a portion thereof) as opposed to the micro shape used to form the structure 102. For example, in some cases, the embolic device 100 includes a structure 102 formed from a spirally wound wire 200, as shown in FIG. 2. In the example of FIG. 2, the structure 102 is spirally wound, but the macro shape formed to create the embolic device is not spirally wound, but instead forms a series of curved, leaf-shaped loops. Thus, the shape of the embolic device 100 should be understood to have the meaning of this macro shape when described herein.

[0041] As shown in FIG. 1, embolic device 100 can be used to treat a vascular defect 104 having a constriction 106, e.g., an opening between a blood vessel and a cavity of an aneurysm 104. In some cases, embolic device 100 can include a portion 108 that is disposed within and / or blocks the aneurysmal constriction 106, and another portion 110 that is disposed within the cavity of the aneurysm 104. In general, portion 108 that blocks constriction 106 can take any shape, e.g., a spiral shape, as shown in FIG. 1. The spiral shape of portion 108 can be formed in any suitable three-dimensional shape, e.g., a disk (as shown in FIG. 1), a sphere, a hemisphere (or partial sphere), a cone, etc. It has been observed that portion 108 having a spiral shape achieves improved blocking of constriction 106 over conventional devices. Portion 110, which is disposed within the cavity of aneurysm 104, can also take any shape, which can be the same or different than portion 108, which blocks aneurysm constriction 106. For example, as shown in FIG. 1, portion 110 can have a spiral shape, but in other embodiments can have other shapes, including random or non-geometric shapes. The spiral of portion 110 can also be formed in any suitable three-dimensional shape, such as a disk, sphere, hemisphere (or partial sphere), cone (as shown in FIG. 1), etc.

[0042] One problem suffered with conventional devices is that their effectiveness in blocking the aneurysmal constriction is significantly affected by the orientation of the device upon delivery to the treatment site, which can sometimes be difficult to achieve in a reproducible manner. Embodiments of the present invention solve this problem by featuring an embolic device that effectively blocks the aneurysmal constriction 106 regardless of its orientation upon placement within the aneurysm 104, or in some cases blocks the aneurysmal constriction 106 in more orientations (e.g., a majority of orientations) than conventional devices.

[0043] One example of a device that blocks the aneurysm constriction 106 in most (or in some cases, all) orientations is the embolic device 300 shown in FIG. 3, which has a generally spherical spiral shape. Certain geometric shapes are described herein, but various embodiments include shapes that have all of their dimensions within 35%, e.g., 25%, 10%, 5%, 2%, and / or 1% of the perfect geometric version of the shape. As illustrated in FIG. 3, the embolic device 300 can be deployed into the aneurysm 104 in any 360 degree orientation and still effectively block the constriction 106 and contact the inner wall (endothelium) of the aneurysm. In some cases, the generally spherical spiral shape of the embolic device 300 can allow for continuous growth of tissue throughout the device 300. For example, the embolic device 300 can provide a continuous path for tissue to grow within the aneurysm cavity, which can allow and / or accelerate healing of the aneurysm 104.

[0044] Exemplary dimensions of the embolic device 300 are shown in Figures 4A-4C. The main diameter (see element 204 in Figure 2) can be about 0.010 inches. The height of the device (distance between the top and bottom coils) can be about 3.1 mm. The diameter of the widest part of the spherical spiral can be about 3.2 mm. The outer diameter of the bottom coil can be about 1.0 mm and the inner diameter of the bottom coil can be about 0.5 mm. The top coil can have similar dimensions as the bottom coil.

[0045] In various embodiments, the embolic devices of the present invention can be formed from a flat sheet (e.g., formed from Nitinol). In general, the flat sheet can be formed into any suitable shape. For example, FIGS. 5A-5B show top views of exemplary embolic devices 500a, 500b formed from a flat sheet in a spiral shape. As noted above, the spiral can take on any suitable 3D shape, such as a disk, a sphere, a hemisphere (or partial sphere), a cone, etc. The flat sheet can also have any desired thickness, for example, within the range of 0.0001 inches to 0.030 inches, within the range of 0.0005 inches to 0.027 inches, within the range of 0.001 inches to 0.025 inches, within the range of 0.002 inches to 0.020 inches, within the range of 0.003 inches to 0.015 inches, within the range of 0.004 inches to 0.010 inches, within the range of 0.006 inches to 0.008 inches. In another embodiment, the flat sheet has a thickness in the range of 0.002 inches to 0.004 inches. In some cases, the width of the flat sheet has a constant width, as shown, for example, by embolic device 500a in FIG. 5A. In other cases, the width of the flat sheet has a draft or tapered (e.g., decreasing or increasing) width, as shown, for example, by embolic device 500b in FIG. 5B.

[0046] In various embodiments, as shown in FIG. 6, an embolic device 600 can be formed by connecting two spiral elements 602, 604 at a connection region 606. In general, the spiral elements 602, 604 can be formed from any suitable structure, such as a microcoil, a flat sheet (as shown in FIG. 6), a thin film, etc. In general, the connected spiral elements can form any 3D shape, such as a disk, a sphere, a hemisphere (or partial sphere), a cone, etc. Referring to FIG. 6, as one example, when an end point 608 of a first spiral element 602 is pulled away from the page, a cone-shaped spiral is formed. As another example, when an end point 610 of a second spiral element 604 is also pushed away from the page, a spherical-shaped spiral is formed. In general, the spiral elements 602, 604 can be joined at the connection region 606 using any suitable technique, such as, for example, welding (e.g., laser, arc, resistance, friction stir), solder, brazing, diffusion bonding, adhesive joints, and interconnect elements (e.g., as described below), etc. In other embodiments, the spiral elements 602, 604 can both be cut (e.g., laser cut) from a single piece of material (i.e., the spiral elements 602, 604 are unitary with each other).

[0047] In various embodiments, the embolic device 700 can include alternating narrow portions 702 and connecting portions 704, as shown, for example, in FIG. 7. The connecting portions 704 surround an opening in at least one plane, for example, the plane of the page, as shown in FIG. 7. In general, the connecting portions 704 can have any suitable shape, for example, diamond-shaped (for example, as shown in FIGS. 7 and 8), circular, rectangular, triangular, etc. In general, the embolic device 700 can be formed from any suitable structure, for example, a coil, a flat sheet, a thin film, combinations thereof, etc. For example, as shown in FIG. 7, the narrow portions 702 can be formed from a single strip of flat sheet material (or multiple strips of flat sheet material without an opening between them), and the connecting portions 704 can be formed by at least two strips of flat sheet material that define a circumference around or surround the opening. The embolic device 700 can also have any desired thickness, for example, within the range of 0.0001 inches to 0.030 inches, 0.0005 inches to 0.027 inches, 0.001 inches to 0.025 inches, 0.002 inches to 0.020 inches, 0.003 inches to 0.015 inches, 0.004 inches to 0.010 inches, or 0.006 inches to 0.008 inches. In another embodiment, the embolic device has a thickness within the range of 0.002 inches to 0.004 inches.

[0048] In some cases, the narrowed portion includes a coil section 802, as shown, for example, in FIG. 8. In some cases, the coil section 802 is disposed over another structure (e.g., a flat sheet, a thin film, etc.). In other cases, the coil section 802 is not disposed over another structure. In general, the coil sections 802 can be attached to the connecting portions 704 using any known technique, for example, by melting a suture onto the end of each coil section 802. Melting a suture onto the end of each coil section 802 can also keep the coil sections 802 positioned between the connecting portions 704. In some cases, the connecting portions 704 can be fixedly attached to adjacent narrowed portions, and a strain relief element 804 can be used to relieve strain between the portions. The strain relief element can be formed from any suitable material, for example, suture material, fused polymer (e.g., polypropylene, polyethylene, high density polyethylene, low density polyethylene, polyurethane, polyether block amide, polyamide, polymer adhesive, etc.), etc.

[0049] In various embodiments, the embolic devices described herein can be introduced, delivered, positioned, and implanted within the vascular defect using a microcatheter. The microcatheter can be a flexible, small diameter catheter, for example, having an inner diameter of 0.015 inches to 0.035 inches (e.g., 0.016 inches to 0.021 inches). The microcatheter may be introduced by an introducer sheath / guiding catheter combination placed in the patient's femoral artery or groin area. In some cases, the microcatheter is guided into the vascular defect using a guidewire (e.g., a long torqueable proximal wire section with a more flexible distal wire section designed to be advanced within tortuous vessels). Such a guidewire may be visible using fluoroscopy and may be used to initially access the vascular defect, thereby allowing the microcatheter to be advanced over and into the defect.

[0050] In some cases, once the tip of the microcatheter accesses the vascular defect, the guidewire is removed from the catheter lumen. An embolic device may then be placed into the proximal open end of the microcatheter and advanced through the microcatheter using a delivery mechanism. The embolic device may be attached to the delivery mechanism via any suitable structure, for example, loop 706 ( FIG. 7 ) on the proximal end of the device. In some cases, the embolic device is in a straightened configuration while positioned within the lumen of the microcatheter. A user (e.g., a physician) may advance and / or retract the embolic device several times to obtain a desired location of the embolic device within the defect. Once the embolic device is satisfactorily positioned, it can be released into the defect. Upon release, the device may form its deployed shape, for example, the spiral shape described above or any other desired configuration. In some cases, the formation of the shape upon deployment into the vascular defect is caused by the shape memory properties of the material (e.g., Nitinol) used to form the embolic device.

[0051] Further discussion regarding the shapes of the embolic devices described herein at various stages of the delivery process is instructive. The embolic device is generally manufactured to have a particular shape in an unconstrained configuration, for example, as the device will be in the operating room prior to packaging or delivery to a patient. The particular shape can include any of the embolic device shapes described herein. During delivery, the embolic device is straightened (as described above) so that it can fit into and be delivered through a microcatheter. Once deployed from the microcatheter into the vasculature defect, the embolic device can reform the shape it was manufactured to have (e.g., aided by a shape memory material). However, in some cases, the embolic device may not reform exactly to the shape it was manufactured to have based on constraints imposed by the vasculature and other surrounding structures.

[0052] In various embodiments, the linking portion 704 of the embolic device 700 shown in FIG. 7 can be collapsed (e.g., the opening can become narrower) when the embolic device 700 is positioned within a microcatheter during delivery. The linking portion 704 can then be expanded (e.g., the opening can become wider) upon deployment of the embolic device into the vascular defect. This allows the embolic device 700 to be more easily delivered through the microcatheter with less friction, while also effectively blocking the narrowing of the aneurysm upon deployment. In some cases, the coil section 802 can further reduce friction of the embolic device during delivery through the microcatheter. As one example, the shape of the coil section 802 can better match the shape of the lumen of the microcatheter. As another example, the coil section 802 can increase the flexibility and malleability of the embolic device. As another example, the coil section 802 can be formed from a material that creates less friction with the inner surface of the microcatheter. The coil section 802 can also be formed from a radiopaque material (e.g., platinum) so that the embolic device can be visualized during delivery, for example if the connecting portion 704 is formed from a non-radiopaque material.

[0053] In various embodiments, the aneurysm 104 can be treated by an embolic device shaped to form at least one infinity-shaped portion, for example, as shown in Figures 9A-9C. As used herein, the term "infinity-shaped" refers to any shape formed by two loops (e.g., loops 902, 904) intersecting at a common point (e.g., point 906), such as a figure-of-eight shape, a beaded shape, etc. As defined herein, notwithstanding any particular geometric or mathematical use of the term "infinity-shaped" in other contexts, the two loops formed by the infinity-shaped portion can be of different or the same size. In some cases, the embolic device 900 can include multiple infinity-shaped portions 902a, 902b, 902c stacked on top of each other, e.g., arranged to match and cover each other (see Figure 9B), or in some cases arranged circumferentially around the inner circumference of the aneurysm (see Figure 9C). In some cases, the embolic device 900 can include a first group of infinite shaped portions 908 (which can include one or more infinite shaped portions) that are arranged along a first axis, and a second group of infinite shaped portions 910 (which can include one or more infinite shaped portions) that are rotated to be arranged at an angle (e.g., about 15°, about 30°, about 45°, about 60°, about 75°, and about 90°) relative to the first axis. For example, the second group of infinite shaped portions can be arranged approximately perpendicular to the first axis. Although both FIGS. 9A and 9B show infinite shaped portions arranged approximately perpendicular to each other, in some cases, the infinite shaped portions can all be arranged along the same axis, e.g., aligned with each other. In other cases, only a single infinite shaped portion is formed. Furthermore, in some cases, the infinite shaped portion blocks the narrowed portion 106 of the aneurysm, while in other cases, the infinite shaped portion can be located within other portions of the aneurysm. For example, as shown in Figure 9C, following deployment, the embolic device can form a series of infinitely shaped sections that can be arranged circumferentially around the interior circumference of an aneurysm or other vascular defect. Such an arrangement can contribute to framing the aneurysm. The infinitely shaped sections can also be arranged in other patterns.In general, any pattern can be used, including a random pattern, in which each infinitely shaped portion can be arranged in any rotational orientation and with any desired overlap relative to another infinitely shaped portion.

[0054] In various embodiments, multiple embolic devices can be joined together using interconnecting elements. The inventors have recognized that if the portion of the device filling the interior of the aneurysm cavity moves (e.g., to expand into intimate contact with the inner wall of the cavity), it may also cause the portion of the device blocking the aneurysm constriction to move or shift, which may affect the effectiveness of the device in blocking the constriction.

[0055] As a solution to this and other problems, embodiments of the present invention include a multi-stage embolic device that includes at least two embolic devices joined by an interconnecting element that allows for independent freedom of movement and / or relative positioning of each embolic device while they remain joined together. For example, as shown in FIG. 10, a multi-stage embolic device 1000 can include a first embolic device 1002 and a second embolic device 1004. In some cases, the first embolic device 1002 is different from the second embolic device 1004. As used herein, the first embolic device 1002 being different from the second embolic device 1004 means that they are two separate devices and not separate parts of a unitary or monolithic single device. The first embolic device 1002 being different from the second embolic device 1004 means that the first embolic device 1002 is of non-unitary (or non-monolithic) structure with the second embolic device 1004. In other words, the first embolic device 1002 is not integrally formed with the second embolic device 1004. The first embolic device 1002 being different from the second embolic device 1004 does not require that the devices 1002, 1004 have any other differences, although in various instances the devices 1002, 1004 can have other differences. For example, the first embolic device and the second embolic device 1002, 1004 can have the same or different dimensions (length, inner diameter, outer diameter, etc.), the same or different stiffness, the same or different porosity, etc. In general, the first embolic device can take any form. For example, the first embolic device 1002 can be a framework device that blocks the narrowing of the aneurysm. In various cases, the first embolic device 1002 can form any of the specific shapes described above, such as a spiral shape, an infinity shape, etc. In general, the second embolic device 1004 can also take any form. For example, the second embolic device 1004 can be a filling device that fills the interior cavity of the aneurysm.In various instances, the second embolic device 1004 can form any of the specific shapes described above, e.g., a spiral shape, an infinity shape, etc., or can assume a random or non-geometric shape. In various embodiments, the first embolic device 1002 and the second embolic device 1004 can be located anywhere within or around the aneurysm 104, not just at the locations shown in FIG.

[0056] In general, the interconnection element 1006 may include any structure that joins the embolic devices 1002, 1004 and allows for independent freedom of movement and / or relative positioning of each embolic device while they remain joined together. As used herein, independent freedom of movement means that the only constraint on movement between the embolic devices is that they remain joined together. In various cases, any movement about the joining point is possible. As a result, movement of the second embolic device 1004 within the aneurysm cavity does not necessarily result in a corresponding movement of the first embolic device 1002 blocking the narrowed portion of the aneurysm. In some cases, allowing this freedom of movement represents an advantage of joining two embolic devices using an interconnection element as opposed to using separate parts of a unitary coil (or other device). Although separate parts of a unitary coil (or other device) may have some independence, they are generally more constrained due to the manufacturing realities of manufacturing a unitary coil (or other device). In contrast, in some cases, joining two different embolic devices with an interconnection element can provide much greater freedom of movement between the devices. In general, the interconnection element 1006 can be located anywhere in or around the aneurysm, depending on where it is advantageous to have independent freedom of movement between the devices, not just where shown in FIG.

[0057] As some non-limiting examples, the interconnection element can include two linked loops, a Nitinol coil (which in some cases covers another interconnection element, and in other cases covers itself), a hook and loop scheme, a hinge, a suture element, a hole and loop, a ball and socket scheme, a pivot joint, a ball and pivot joint, a universal joint, a saddle joint, any mechanical articulating joint with one or more degrees of freedom, or a combination thereof. In some cases, the interconnection element 1006 can be formed from a portion of the first embolic device 1002 and the second embolic device 1004. For example, one component of the interconnection element 1006 can be a loop formed at the distal or proximal end of the first embolic device 1002 (e.g., being of one structure or integral with the first embolic device 1002), and another component of the interconnection element 1006 can be a loop formed at the distal or proximal end of the second embolic device 1004 (e.g., being of one structure or integral with the second embolic device 1004). In other cases, the interconnection element 1006 is not unitary or integral with either the first embolic device 1002 or the second embolic device 1004 (i.e., the interconnection element is non-unitary or non-monolithic or non-integral with each of the first and second embolic devices 1002, 1004), but instead is fastened, adhered, and / or attached to the first and second embolic devices 1002, 1004. In other cases, the interconnection element 1006 is unitary or integral with one of the first and second embolic devices 1002, 1004 and non-unitary or non-monolithic or non-integral with the other embolic device. In various embodiments, regardless of the particular structure employed, two of first embolic device 1002, second embolic device 1004, and interconnecting element 1006 are of non-unitary structure with respect to one another.

[0058] 11A-C are photographs showing different views of an exemplary interconnection element 1006. FIGS. 11A-B depict an exemplary interconnection element 1006 formed from two linked loops. FIG. 11C depicts an exemplary interconnection element 1006 formed from two linked loops covered by a nitinol coil (e.g., a different coil than the first and second embolic devices 1002, 1004). In some embodiments, the interconnection element 1006 can include a nitinol coil that does not itself cover another interconnection element. As shown in FIG. 11C, in some cases in which the interconnection element 1006 includes a nitinol coil, the nitinol coil is adhered to the first and second embolic devices 1002, 1004. In general, the nitinol coil (or any other interconnect structure bonded to one or both of the embolic devices 1002, 1004) can be bonded to one or both of the embolic devices 1002, 1004 using any known technique. In some implementations, a desirable bonding technique features adequate material biocompatibility and strength while minimizing the length required to produce an end-to-end fixation between the interconnect element 1006 and the embolic device 1002, 1004 (which in some cases results in an undesirable length of stiffness). As an example, solder (e.g., gold, silver, or other desirable solder material) can be used to attach the nitinol coil interconnect element 1006 to the embolic device 1002, 1004. Other exemplary bonding techniques include (but are not limited to) the use of adhesives, welding (e.g., laser, arc, spot), brazing, diffusion bonding, and the like.

[0059] 12 is a photograph showing an exemplary multi-stage embolic device 1000 delivered into a model aneurysm 104. In some instances, an interconnecting element 1006 joins two elements that are intended to be delivered to the vascular defect and remain at the vascular defect for the duration of the treatment cycle other than delivery. In such instances, the interconnecting element 1006 does not join the embolic device to the device (e.g., a microcatheter or delivery pusher) used to deliver the embolic device to the vascular defect.

[0060] In various embodiments, more than two embolic devices can be joined together, for example, in parallel, using more than one interconnection element. Alternatively, more than two embolic devices can be joined together in series, using more than one interconnection element (e.g., up to one less than the number of embolic devices). Combinations of series and parallel arrangements are also contemplated. In general, any number of embolic devices (e.g., 2, 3, 4, 5, 10, etc.) can be joined. As shown in FIG. 13, embolic device 1000 can include a first embolic device 1002 joined in series with a second embolic device 1004 using a first interconnection element 1006a, and a second embolic device 1004 joined in series with a third embolic device 1008 using a second interconnection element 1006b. In general, the third embolic device 1008 can take any form (as can any additional embolic devices). For example, the third embolic device 1008 can be the final device that further fills the interior cavity of the aneurysm. In various cases, the third embolic device 1008 (and any additional embolic devices) can form any of the specific shapes described above, e.g., a spiral shape, an infinity shape, etc., or can take on a random or non-geometric shape. The third embolic device 1008 (and any additional embolic devices) can be located anywhere within or around the aneurysm.

[0061] In various embodiments, each of the embolic devices (e.g., 1002, 1004, 1008) of the multi-stage embolic device 1000 can have different properties and behave differently from one another. In general, any embolic device property can be variable between embolic devices. For example, some or all of the embolic devices can have different sizes, shapes, lengths, stiffness, porosity, etc. In other cases, some or all of the embolic devices can have some or all of the same properties. This customizable and independent nature of the embolic device properties can allow the operator (e.g., physician) more freedom to shape and control the deployment and positioning of the coil than with conventional devices. As an example, the operator can deliver the coil so that it is first positioned in a first orientation and then pivoted to be positioned in a different orientation at an angle (e.g., 15°, 30°, 45°, 60°, 75°, 90°, etc.) relative to the first orientation.

[0062] As noted above, in various embodiments, the embolic devices described herein can include structures (e.g., microcoils, flat sheets, thin films, etc.) that are covered by a covering element or that are not covered by a covering element. With reference to multi-stage embolic device 1000, in various embodiments, any of the individual embolic devices (e.g., 1002, 1004, 1008, etc.) can be either all or not covered by a covering element.

[0063] Unless expressly explained elsewhere in this application (e.g., the use of the word "substantially" in relation to geometric shapes), as used herein, when the term "substantially" or "about" precedes a quantitative value, the present disclosure also includes not only the specific quantitative value itself, but also a ±10% variation from the nominal value, unless otherwise indicated or inferred.

[0064] While certain embodiments of the present invention have been described, it will be apparent to those skilled in the art that other embodiments incorporating the concepts disclosed herein may be used without departing from the spirit and scope of the invention. The described embodiments are therefore to be considered in all respects as illustrative and not restrictive.

Claims

1. 1. A multi-stage embolic device for use in treating a vascular disorder, the multi-stage embolic device comprising: a first embolic device; a second embolic device different from the first embolic device; and a hook and loop interconnection element joining the first and second embolic devices, the hook and loop interconnection element allowing movement of the second embolic device without corresponding movement of the first embolic device while the first and second embolic devices remain joined together; a coil disposed across the hook and loop interconnection element, the coil being attached to the first embolic device and the second embolic device; Equipped with each of the first and second embolic devices includes a plurality of narrow portions and a plurality of connecting portions, each of the plurality of connecting portions connecting one of the plurality of narrow portions to another of the plurality of narrow portions; each of the first embolic device and the second embolic device is formed from at least one of a coil, a flat sheet, and combinations thereof; A multi-stage embolic device, wherein the first embolic device has an end and the second embolic device has an end, the end of the first embolic device being attached to the end of the second embolic device by the hook and loop interconnection element.

2. 10. The multi-stage embolic device of claim 1, wherein at least one of the first embolic device and the second embolic device comprises a material selected from the group consisting of platinum, nitinol, platinum alloys, and combinations thereof.

3. The multi-stage embolic device of claim 1 , wherein at least a portion of the multi-stage embolic device is radiopaque.

4. 2. The multi-stage embolic device of claim 1, wherein at least one of the first embolic device and the second embolic device comprises a flexible structure including a plurality of narrow portions and a plurality of connecting portions, each of the plurality of connecting portions connecting one of the plurality of narrow portions to another of the plurality of narrow portions, each connecting portion having a diamond-shaped shape.

5. 2. The multi-stage embolic device of claim 1, wherein at least one of the first and second embolic devices comprises a flexible structure comprising a plurality of narrowed portions and a plurality of connecting portions, each of the plurality of connecting portions connecting one of the plurality of narrowed portions to another one of the plurality of narrowed portions, each of the plurality of connecting portions compressing when the multi-stage embolic device is positioned within a microcatheter.

6. The multi-stage embolic device of claim 5 , wherein each of the multiple linking portions expands upon deployment of the multi-stage embolic device from the microcatheter.

7. 2. The multi-stage embolic device of claim 1, wherein at least one of the first and second embolic devices comprises a flexible structure comprising a plurality of narrow portions and a plurality of connecting portions, each of the plurality of connecting portions connecting one of the plurality of narrow portions to another of the plurality of narrow portions, and the plurality of narrow portions and the plurality of connecting portions alternating at consistent intervals.

8. 2. The multi-stage embolic device of claim 1, wherein at least one of the first embolic device and the second embolic device comprises a flexible structure comprising a plurality of narrow portions and a plurality of connecting portions, each of the plurality of connecting portions connecting one of the plurality of narrow portions to another of the plurality of narrow portions, and the plurality of narrow portions and the plurality of connecting portions alternating at inconsistent intervals.

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