Implant with increased braid density and method of making

Abstract

An implant comprises a braided body configured for placement within a cerebral aneurysm and having a longitudinal axis, the braided body comprising a proximal face, at least an inner portion of the proximal face twisted around the longitudinal axis.

Description

IMPLANT WITH INCREASED BRAID DENSITY AND METHOD OF MAKINGBACKGROUND OF THE INVENTIONField of the Invention

[0001] The field of the invention generally relates to embolic devices for filling spaces in the vascular system, including cerebral aneurysms or left atrial appendages. In some cases, the embolic devices may be used to embolize native vessels. The field of the invention also relates to braided implants with increased braid density and to methods for providing an increased braid density in braided implants.SUMMARY OF THE INVENTION

[0002] In one embodiment of the present disclosure, an implant includes a braided body configured for placement within a cerebral aneurysm and having a longitudinal axis, the braided body including a proximal face, at least an inner portion of the proximal face twisted around the longitudinal axis.

[0003] In another embodiment of the present disclosure, an apparatus for treating an aneurysm in a blood vessel includes and occlusion device including a cover having a proximal end and a distal end and including a tube constructed of braided wires, wherein the tube is inverted on itself, the tube having a proximal end, a distal end, and a longitudinal axis, wherein the cover includes a circular-bounded layer portion at or adjacent the proximal end of the cover, the circular-bounded layer portion including a first twisted configuration in the braided wires in relation to the longitudinal axis, the circular -bounded layer portion including an increased braid density as compared to an untwisted configuration.

[0004] In yet another embodiment of the present disclosure, a method of constructing an apparatus for treating an aneurysm in a blood vessel includes creating a braided tube from a plurality of wires, each of the plurality of wires having a diameter of between 0.0005” and 0.0015”, the braided tube having a first end, a second end, and a longitudinal axis, inverting the braided tube to form an inner layer and an outer layer, forming a cover from the inner layer and the outer layer, the cover having a proximal end and a distal end, twisting one or both of the first end and / or the second end of the braided tube in relation to the longitudinalaxis while restricting a portion of the braided tube from being twisted such that a braid density of a proximal portion of the cover is increased at a twisted area, and locking the twisted area in place.BRIEF DESCRIPTION OF THE DRAWINGS

[0005] FIG. 1 is a side view of an apparatus comprising an occlusion device for treating an aneurysm in a blood vessel, according to an embodiment of the present disclosure.

[0006] FIG. 2 is a sectional view of the occlusion device of FIG. 1 within a delivery catheter.

[0007] FIG. 3 is a cross-sectional view of the occlusion device of FIG. 1 taken through line 3-3.

[0008] FIG. 4 is a cross-sectional view of an alternative embodiment of the present disclosure.

[0009] FIG. 5 is a cross-sectional view of the of the occlusion device of FIG. 1 taken through line 5-5.

[0010] FIG. 6 is a top view of a cover of an occlusion device, according to an embodiment of the present disclosure.

[0011] FIG. 7 is a top view of a cover of an occlusion device, according to an embodiment of the present disclosure.

[0012] FIG. 8A is a detailed central top view of the cover of the occlusion device of FIG.6.

[0013] FIG. 8B is a detailed central top view of the cover of the occlusion device of FIG.7.

[0014] FIG. 8C is an alternative embodiment of the occlusion device of FIG. 8A, according to an embodiment of the present disclosure.

[0015] FIG. 8D is an alternative embodiment of the occlusion device of FIG. 8B, according to an embodiment of the present disclosure.

[0016] FIGS. 9-12 illustrate the implantation of the occlusion device of FIG. 1 in an aneurysm of a blood vessel of a patient.

[0017] FIG. 13 is a perspective view of a twisting fixture, according to an embodiment of the present disclosure.

[0018] FIG. 14 is an exploded view of the twisting fixture of FIG. 13.

[0019] FIG. 15 is a sectional view of a braided tube that has been inverted and placed in an intermediate configuration, without showing the twisting fixture, according to an embodiment of the present disclosure.

[0020] FIG. 16 is a sectional view of the intermediate configuration of the braided tube of FIG. 15 when placed in a first position on the twisting fixture, according to an embodiment of the present disclosure.

[0021] FIG. 17 is a sectional view of the intermediate configuration of the braided tube of FIG. 15 when placed in a first position on a first alternative twisting fixture, according to an embodiment of the present disclosure.

[0022] FIG. 18 is a side view of the inverted, braided tube on a second alternative twisting fixture prior to twisting, according to an embodiment of the present disclosure.

[0023] FIG. 19 is a side view of the inverted, braided tube on the second alternative twisting fixture during twisting, according to an embodiment of the present disclosure.DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

[0024] Aneurysms are abnormal bulging or weakening of a blood vessel, often an artery, and can have many complications. A bulging of the blood vessel can disrupt or put pressure on surrounding tissues. Cerebral aneurysms can result in a variety of side effects, such as impaired vision, impaired speech, impaired balance, etc. Further, the aneurysm creates a volume that is not along the main flow path of the blood through the blood vessel. It therefore can serve as a location for blood to become stagnant and, due to swirling eddy currents, can contribute to the formation of a thromboembolism. If an aneurysm ruptures, it can cause severe internal bleeding, which in cerebral arteries can often become fatal.

[0025] Aneurysms can be treated externally with open surgery. Such procedures typically involve closing off the entrance or "neck" of the aneurysm with a device such as vascular clip, clamp or a ligature. However, such open surgical procedures can be highly invasive and may lead to trauma to the adjacent tissue and other side effects.

[0026] Aneurysms can also be treated through endovascular procedures. In one procedure, detachable lengths of wires (e.g., coils) are inserted into the interior volume of the aneurysm using a catheter. The coils are intended to fill the volume of the aneurysm to decrease the flow of blood into the aneurysm, inducing stagnation of flow and stimulate clotting within the aneurysm. In settings of large cerebral aneurysms, filling of the aneurysm with multiple coils can lead to mass effect that may induce brain swelling and be an independent cause for new symptoms. In another procedure, for aneurysms with a relatively large neck, the adjunctiveuse of stents assists with the retention of the coils within the aneurysm. This approach may have a contraindication to being used when treating ruptured aneurysm, due to the need for additional anti -thrombotic medications. In another procedure, the coils are held in the volume of the aneurysm with a temporary balloon that is inflated in the blood vessel. The balloon is deflated and removed once the mass of coils is secured. In still another procedure, a stent device is placed in the artery to promote flow of blood past the aneurysm. This leads to stagnation of the blood within the aneurysm and thrombosis inside the aneurysm volume. However, a side branch of a main artery in which the stent device is placed may become trapped or "jailed," which can impede access to the side branch. In other instances, the side branch can become clotted off, possibly causing a stroke. Additionally, such a procedure generally requires the use additional anti -thrombotic medications, which limits the use of such devices in the setting of treatment of ruptured aneurysms. The stent device is often formed with a relatively tight weave. While the tight weave increases the effectiveness of the stent device in diverting the blood flow, it also impedes or prevents access to the volume of the aneurysm or the jailed artery. In the event that the aneurysm fails to clot, the obstruction of the aneurysm by the stent device prevents the possibility of placing embolic devices inside the aneurysm. Additional procedures such as the placement of additional stents or open surgery may then be required to treat the residual.

[0027] Procedures that involve packing the volume of the aneurysm can suffer from several common shortcomings. First, it can take many coils of wire to fill the volume of the aneurysm, which is time consuming and increases the time it takes to complete the procedure. Further, the coils may be compacted over time to occupy a smaller percentage of the total volume of the aneurysm. A great enough compaction of the coils can be considered a recurrence of the aneurysm and may require further treatment.

[0028] FIG. 1 illustrates an occlusion device 100 configured for placement within an aneurysm. The occlusion device 100 comprises a cover 102 having a maximum outer diameter DMAX and a minimum outer diameter DMIN. The cover 102 has a proximal end 131 and a distal end 133. In some embodiments, the cover 102 is circular, with substantially the same diameter D at any measurement around the perimeter at each transverse plane. In other embodiments, the cover 102 is non-circular, and can comprise a cross-section having an ellipse, an oval, a polygon or other shapes. In the non-circular embodiments, the cover 102 comprises a minimum transverse dimension and a maximum transverse dimension. In the particular case of an ellipse or an oval shape, the cover 102 comprises a major diameter and a minor diameter. The minor diameter or minimum transverse dimension is configured to belarger than a maximum transverse dimension of an opening into the aneurysm (the neck portion). Thus, the cover 102 is configured to completely cover the neck portion, and thus to cause stagnation of blood within the aneurysm, leading to occlusion.

[0029] The cover 102 is constructed from a mesh (braided) Nitinol (nickel -titanium alloy) tube 105 that is inverted on itself at a fold 112. The mesh tube 105 has a first end 104 and a second end 106 (FIGS. 1, 3, and 4). The second end 106 is folded back over the outer diameter of the first end 104 thus providing an outer facing surface 108 and an inner facing surface 110. The mesh tube 105 is heat-formed such that the cover 102 comprises an expanded portion and the first end 104 and second end 106 comprise unexpanded (or partially expanded) portions. The cover 102 is fabricated as an inverted mesh tube 105 having a simple straight elongate configuration, and is subsequently formed into the shape shown in FIG. 1, and heat set into this shape. For example, the inverted mesh tube 105 can be constructed as a single layer mesh tube formed of at least some nickel -titanium alloy filaments, and then inverted on itself. The inverted mesh tube 105 can then be placed into a die or mold comprising one or more pieces, to hold it in the shape of the cover 102. Then, the cover 102 can be subjected to an elevated temperature and then cooled, to lock in the shape, resulting in a cover 102 having at least some superelastic properties. The cover 102 includes a lower portion 107 opposite the fold 112. The lower portion 107 comprises a concavity 109, but in other embodiments can be substantially flat, generally defining a plane, and in other embodiments can have a more frustoconical internal shape. The cover 102 has a frustoconical outer shape 111 defined by the outer facing surface 108. The frustoconical shape 111 represents an increase in diameter between the minimum diameter DMIN and the maximum diameter DMAX. In some embodiments, the cover 102 can comprise a toroidal, or partially- toroidal shape. Opposite the concavity 109 in the outer facing surface 108 is a convexity 115 in the inner facing surface 110. The convexity 115 can in some embodiments have a different shape than the concavity 109, but in the embodiments presented herein, the convexity 115 and the concavity 109 are matched, are flush with each other, or are at least in close proximity to each other, such that the outer facing surface 108 and inner facing surface 110 at the convexity 115 and concavity 109 provide the two braided layers (inner layer 123, outer layer 125), each with a particular braid density or a particular range of braid densities. In some embodiments the braid density or range of braid densities of the two braided layers 123, 125 are similar to each other and in some embodiments they are significantly different from each other. In some of the embodiments disclosed herein, the braid density of one or more of the braided layers 123, 125 at the outer facing surface 108 and the inner facingsurface 110 is changed via a rotational twisting process along a longitudinal axis, as will be further disclosed.

[0030] The occlusion device 100 includes a distal end 118 and a proximal end 120. The cover 102 at the fold 112 has an inner diameter DIN and below the fold 112 has an undercut diameter DUN that is larger than the inner diameter DIN. The fold 112, thus, forms a circumferential lip 113 within a top opening 103 of the cover 102. The circumferential lip 113 defines the inner diameter DIN. AS formed (e.g., heat-formed), the cover 102 has an expanded configuration (shown in FIG. 1) and a collapsed configuration, shown in FIG. 2. The cover 102 comprises two mesh layers 123, 125 that provide the inner facing surface 110 and the outer facing surface 108, respectively. In some embodiments, the cover 102 can comprise some nickel -titanium alloy filaments and some radiopaque elements, comprising platinum, gold, tantalum, or alloys of any of these or other radiopaque materials. In some embodiments, the filaments can comprise drawn filled tubes (DFT), such as those comprising a nickel -titanium alloy outer wall and an internal platinum core. The radiopaque material allows the cover 102 to be visible on radiographs or fluoroscopy. The occlusion device 100 can be configured by controlling how much radiopaque material is used, by either the ratio of radiopaque filaments to non-radiopaque filaments, or by the amount of platinum core in the drawn filled tubes. In this manner, the cover 102 can be selectively fabricated to be sufficiently visible, but not over visible, e.g., overly bright, such that other objects are obscured. In some embodiments, whether any of the filaments comprise radiopaque materials or not, a marker band 121 is attached around the proximal end 120 of the occlusion device 100, by adhesive, hot melt, or epoxy bonding, or swaging, brazing, welding or other mechanical attachment.

[0031] In some embodiments, the filaments, or wires 229, 231 (FIGS. 6-8D), each have a diameter of between about 0.0005 inch and about 0.00125 inch. In some embodiments, the filaments, or wires 229, 231, each have a diameter of between about 0.0005 inch and about 0.0015 inch. In some embodiments, the filaments, or wires 229, 231, each have a diameter of between about 0.0005 inch and about 0.001 inch.

[0032] Extending from the top opening 103 in a distal portion 119 of the cover 102 is a first doubled-over or looped tubular braided mesh 122. The first looped tubular mesh 122 has a smooth apex 124 configured in some embodiments to safely contact an interior wall of an aneurysm, for example, to provide some anchoring within the aneurysm. The tubular mesh 122 has a first end 126 and a second end 128 (FIG. 3), and an intermediate portion 130 extending between the first end 126 and second end 128. In the embodiment shown in FIGS.1-3, the first end 126 and second end 128 are substantially unexpanded or compressed for the original braided tube configuration and are inserted within a lumen 132 within the inverted mesh tube 105 that forms the cover 102, particularly at the first end 104 and a second end 106 of the mesh tube 105 that forms the cover 102 (FIG. 3). The first end 126 and second end 128 of the tubular mesh 122 can be bonded into the lumen 132 with adhesive 134, or alternatively with epoxy, or welded or bonded with any other securement technique. The ends 104, 106 of the inverted mesh tube 105 that forms the cover 102 are also bonded. In the embodiment of FIG. 1, the bonded portion forms the proximal end 120 of the occlusion device 100. The first end 126 and second end 128 can each be compressed or deformed into an oval, elliptical (shown), or D-shape, so that they may more efficiently fit into a circular cross-section of the lumen 132. An alternative embodiment is shown in FIG. 4, wherein the first end 126 includes a cut 142 in its wall 144, which allows the second end 128 to be inserted into the internal space 146 at the first end 126, created by the cut 142. Thus, the second end 128 is held within the first end 126, and the first end 126 and second end 128 are secured within the lumen 132, e.g., with adhesive 134, epoxy, welding or other securing techniques. The tubular mesh 122 is constructed from a mesh (braided) Nitinol (nickel -titanium alloy) tube, and can also include filaments of platinum or other radiopaque materials, as well as the nickel -titanium filaments. Drawn filled tubes can also be utilized in some embodiments. In some embodiments, there can also be a second doubled-over or looped tubular mesh, or even a third or more.

[0033] Between the apex 124 of the intermediate portion 130 and the first and second ends 126, 128, the tubular mesh 122 intermediate portion 130 also comprises a first leg 136 and a second leg 138, extending therefrom. Each of the first leg 136 and second leg 138 comprises a different portion of the tubular mesh 122. Thus, the tubular mesh 122 is a single layer mesh (braided wires 141) tube extending from its first end 126 through the first leg 136 and around the apex 124, then through the second leg 138 to the second end 128. In the embodiment shown in FIG. 1, the first leg 136 and second leg 138 are shown in their substantially unrestrained, expanded states, and, in this embodiment, the first leg 136 and second leg 138 do not completely contact each other at a central axis 140, thus defining an opening 117. However, if implanted in an aneurysm that is narrower than width W of the tubular mesh 122, this opening 117 can be diametrically compressed such that the first leg 136 fully touches the second leg 138, as shown in FIG. 5. In FIG. 5, it can be appreciated that the first leg 136 and second leg 138 each form a more oval, elliptical, or D-shaped cross- sectional shape in this compressed condition (with the aneurysm 10 shown), rather than a circular shape. Also, the first leg 136 and second leg 138 together form a first transversedimension TDx and a second transverse dimension TDy. In some embodiments, the first transverse dimension TDx is greater than the second transverse dimension TDy. In other embodiments, the first transverse dimension TDx is less than the second transverse dimension TDy. In some embodiments, the first transverse dimension TDx is substantially equal to the second transverse dimension TDy. In some cases, the first transverse dimension TDx is configured to contact an interior wall of an aneurysm, to stabilize the occlusion device 100 within the aneurysm, while the second transverse dimension TDy is not. In some cases, the second transverse dimension TDy is configured to contact an interior wall of an aneurysm, to stabilize the occlusion device 100 within the aneurysm, while the first transverse dimension TDx is not. In some cases, the occlusion device 100 may be placed into a non-circular aneurysm, and in these cases, the first transverse dimension TDx and the second transverse dimension TDy may each be configured to contact an interior wall of an aneurysm at different circumferential locations, as the aneurysmal cross-section may be more oval or elliptical, or another non-circular shape.

[0034] Returning to FIG. 2, the occlusion device 100 is shown with both the cover 102 and the tubular mesh 122 in their collapsed or compacted configurations while it is placed into the lumen 148 of a delivery catheter 150 having a distal end 162 and a proximal end 164. The delivery catheter 150 can be a microcatheter having a luminal diameter of 0.017 inch or 0.021 inch, 0.025 inch, or 0.028 inch, or other sizes. An elongate pusher 152, having a distal end 154 and a proximal end 156, can comprise a wire, a hypo tube, or another elongate shaft or structure having column support, and is detachably coupled at its distal end 154 to the proximal end 120 of the occlusion device 100. A detachable joint 158 can comprise one of a number of detachment systems, including but not limited to pressurized detachment, electrolytic detachment mechanisms, hydraulic detachment mechanisms, mechanical or interlocking detachment mechanisms, chemical detachment mechanisms, heat -activated detachment systems, or frictional detachment systems. The detachable joint 158 can be activated to allow detachment after the occlusion device 100 is deployed within the aneurysm 10, to allowed removal of the pusher 152. During delivery, the pusher 152 is held on its proximal end 156 by a user and pushed in a forward longitudinal direction 160, in order to advance the occlusion device 100 to the distal end 162 of the delivery catheter 150.

[0035] FIG. 6 and FIG. 7 illustrate a first embodiment of an occlusion device 200' and a second embodiment of an occlusion device 200", respectively, each viewed from above. Unlike the occlusion device 100 of FIG 1, the occlusion devices 200', 200" do not comprise atubular mesh 122, but rather comprise only a cover 202. The occlusion devices 200', 200" can be appropriate for use in the embolization of aneurysms, wherein anchoring with a tubular mesh 122 is not required or is not desired, for example. These embodiments also allow a better view (from above) of the inner facing surface 210. The outer facing surface 208 is also visible when viewing through the top opening 203 of the cover 202. The generally diamond-shaped spaces 227 (227', 227", 227'", 227"") between the wires 229 of the inner layer 223 comprising the inner facing surface 210 act as open windows to a person viewing FIGS. 6 and 7, such that the wires 231 of the outer layer 225 comprising the outer facing surface 208 are also visible. FIGS. 6 and 7 each illustrate the circumferential lip 213 and the inner diameter DIN it defines.

[0036] The occlusion device 200' of FIG. 6 is formed such that, when the first end 204 and the second end 206 of the mesh tube 205 of the cover 202 are bonded in place at the proximal end 220 of the occlusion device 200', the first end 204 and the second end 206 of the mesh tube 205 have substantially no rotation with respect to each other. The generally diamond-shaped spaces 227' between the wires 229 of the inner layer 223 have a similar shape in comparison with the generally diamond-shaped spaces 227" between the wires 231 of the outer layer 225. This is further shown in FIG. 8A. In contrast to this, the occlusion device 200" of FIG. 7 is formed such that, when the first end 204 and the second end 206 of the mesh tube 205 of the cover 202 are bonded in place (e.g., with adhesive 234) at the proximal end 220 of the occlusion device 200", the first end 204 and the second end 206 of the mesh tube 205 have first been twisted with respect to each other, such that the generally diamond-shaped spaces 227'" between the wires 229 of the inner layer 223 have a significantly different shape in comparison with the generally diamond-shaped spaces 227"" between the wires 231 of the outer layer 225. This is further shown in FIG. 8B. The different shape of the diamond-shaped spaces 227'" which are substantially longitudinally adjacent the diamond-shaped spaces 227"" creates an increased braid density at the proximal end 220 of the occlusion device 200" of FIG. 7 (at the cover 202) compared to the braid density at the proximal end 220 of the occlusion device 200' of FIG. 6 (at the cover 202). In some embodiments, the twist / relative rotation between the ends 204, 205 of the mesh tube 205 of the cover 202 comprises about 5° to about 270°. In some embodiments, the twist / relative rotation between the ends 204, 205 of the mesh tube 205 of the cover 202 comprises about 5° to about 180°. In some embodiments, the twist / relative rotation between the ends 204, 205 of the mesh tube 205 of the cover 202 comprises about 5° to about 90°. In some embodiments,the twist / relative rotation between the ends 204, 205 of the mesh tube 205 of the cover 202 comprises about 5° to about 60°. In some embodiments, the twist / relative rotation between the ends 204, 205 of the mesh tube 205 of the cover 202 comprises about 15° to about 50°. In some embodiments, the twist / relative rotation between the ends 204, 205 of the mesh tube 205 of the cover 202 comprises about 45°. In some embodiments, the adhesive 234 comprises UV-curable adhesive. In some embodiments, the adhesive 234 comprises flexible urethane adhesive. In some embodiments, the adhesive 234 comprises a narrow viscosity range adhesive so that it can be controllably wicked in the desired area of bonding. In other embodiments, an epoxy is utilized.

[0037] In FIG. 8A, a first inner portion 245 is shown untwisted in relation to a radially peripheral portion 244. This untwisted configuration is maintained in static relation by the adhesive 234. In FIG. 8B, a first inner portion 246 is shown twisted in relation to a radially peripheral portion 247. This twisted configuration is maintained in static relation by the adhesive 234. Diamond-shaped space 248 is substantially un-deformed by the twisting. Diamond-shaped space 249, however, is at least partially deformed by the twisting, with a curved deformation visible in FIG. 8B, and becoming more significant in the direction toward the first inner portion 246. The circumferential orientation of the diamond-shaped space 248 in relation to the first inner portion 246 is different than it would have been in an untwisted configuration (e.g., the configuration of FIG. 8A). Though the term “diamond-shaped space 249” is used, the particular diamond shaped space 249 is curved, and is elongated. Thus, the name is only generally descriptive, because of how braids are formed. Furthermore, there can be a three-dimensionality of the braided portions, and thus the diamond-shaped spaces 248, 249 can have a further concave / convex shape due to curvature of the wires. This is unlike a traditional sketched diamond-shape that has four straight lines creating its boundary.

[0038] FIG. 8C illustrates an alternative embodiment of the embodiment of FIG. 8 A. The adhesive 234 has been applied to a larger diametric area.

[0039] FIG. 8D illustrates an alternative embodiment of the embodiment of FIG. 8B. The adhesive 234 has been applied to a larger diametric area.

[0040] In the occlusion device 200' of FIG. 8A, the adhesive 234 is cured interstitially amongst the wires 229, 231, adhered to the wires 229, 231, and substantially filling some, most, or all of the diamond-shaped spaces 227', 227" within the area bounded by the extent of the adhesive 234. The bounded area is generally a circle, but can include some areas in which the adhesive 234 has wicked a bit more in the outward radial direction. For example, inFIG. 8A, at 00:30 and 03:00. In the occlusion device 200" of FIG. 8B, the adhesive 234 is cured interstitially amongst the wires 229, 231, adhered to the wires 229, 231, and substantially filling some, most, or all of the diamond-shaped spaces 227'", 227"" within the area bounded by the extent of the adhesive 234. The bounded area is generally a circle, but can include some areas in which the adhesive 234 has not comparably dispersed radially. For example, in FIG. 8B, at 09:00.

[0041] In the occlusion device 200' of FIG. 8C, the adhesive 234 is cured interstitially amongst the wires 229, 231, adhered to the wires 229, 231, and substantially filling some, most, or all of the diamond-shaped spaces 227', 227" within the area bounded by the extent of the adhesive 234. The bounded area is generally a circle, but can include wavy or uneven areas along its periphery. In the occlusion device 200" of FIG. 8D, the adhesive 234 is cured interstitially amongst the wires 229, 231, adhered to the wires 229, 231, and substantially filling some, most, or all of the diamond-shaped spaces 227'", 227"" within the area bounded by the extent of the adhesive 234. The bounded area is generally a circle, but can include wavy or uneven areas along its periphery.

[0042] Upon examination, the circular area closer to the inner portion 246 of the occlusion device 200" in FIG. 8B includes an increased wire density and lower porosity than the outer annular area radially spaced from it because of the deformed / twisted diamond-shaped spaces 249, and the effective manner in which they close the voids (e.g., “diamonds”). Furthermore, some of the space is substantially or completely closed by the adhesive 234 itself. The occlusion device 200" in FIG. 8D has substantially or completely closed voids (e.g., “diamonds”) mainly or completely due to the coverage of the adhesive 234. However, a lesser adhesive 234 coverage, such as that shown in FIG. 8B, or even less coverage, can still be effective in maintaining (“freezing”) the deformed curves of the inner area in FIGS. 7, 8B, and 8D, such that the wires 229, 231, themselves, are able to increase their density, thus minimizing the amount of voided space, and significantly decreasing porosity in areas where there is little or no adhesive 234.

[0043] The dual layers of mesh in the occlusion device at the lower portion 200", combined with the lower porosity (increased wire density) from the multiple deformed / twisted diamond-shaped spaces 249 (caused by increased curvature in the wires 229, 21), create an occlusion device 200" that, when implanted, provides greater disruption of blood flow into the aneurysm 10. This, thus, causes accelerated effective thrombosis toisolate the internal volume 14 of the aneurysm 10 from blood flow through the blood vessel.12.

[0044] An implant, according to an embodiment of the present disclosure, comprises a braided body configured for placement within a cerebral aneurysm and having a longitudinal axis, the braided body comprising a proximal face, at least an inner portion of the proximal face twisted around the longitudinal axis. In some embodiments, the proximal face is substantially transverse to the longitudinal axis. In some embodiments, the braided body comprises a proximal cover having a distal concavity, and a curved tubular mesh having an apex that extends from the distal concavity of the proximal cover. In some embodiments, the tubular mesh comprises a braided tube. In some embodiments, the braided body comprises a braided tube that is inverted on itself. In some embodiments, the braided tube comprises a low profile first end and a peripheral portion radially spaced from the first end, the first end and peripheral portion located at or adjacent to a proximal end of the braided body. In some embodiments, the first end is maintained in a rotated position in relation to the peripheral portion. In some embodiments, the implant further comprises a securing agent statically coupling the first end in relation to the peripheral portion to maintain the at least an inner portion of the proximal face in a twisted configuration. In some embodiments, the securing agent comprises one or more material selected from the list consisting of: an adhesive, an epoxy, a hot melt, a braze, a solder, and a welded portion of the first and second ends. In some embodiments, the at least an inner portion of the proximal face carries at least some of the securing agent. In some embodiments, the proximal face comprises a circular -bounded layer portion comprising a first twisted configuration of braided wires in relation to the longitudinal axis as compared to an untwisted configuration. In some embodiments, the circular-bounded layer portion comprises a 25% or more increased braid density as compared to the untwisted configuration, wherein the at least an inner portion of the proximal face is not twisted around the longitudinal axis. In some embodiments, the circular-bounded layer portion comprises a 50% or more increased braid density as compared to the untwisted configuration, wherein the at least an inner portion of the proximal face is not twisted around the longitudinal axis. In some embodiments, the circular-bounded layer portion comprises a 25% to 85% increased braid density as compared to the untwisted configuration, wherein the at least an inner portion of the proximal face is not twisted around the longitudinal axis. In some embodiments, the circular-bounded layer portion comprises a 75% or more increased braid density as compared to the untwisted configuration, wherein the at least an inner portion of the proximal face is not twisted around the longitudinal axis.

[0045] An apparatus for treating an aneurysm, according to an embodiment of the present disclosure, comprises an occlusion device comprising a cover having a proximal end and a distal end and comprising a tube constructed of braided wires, wherein the tube is inverted on itself, the tube having a proximal end, a distal end, and a longitudinal axis, wherein the cover comprises a circular-bounded layer portion at or adjacent the proximal end of the cover, the circular-bounded layer portion comprising a first twisted configuration in the braided wires in relation to the longitudinal axis, the circular-bounded layer portion comprising an increased braid density as compared to an untwisted configuration. In some embodiments, the proximal end of the cover comprises an inner layer and an outer layer of the tube. In some embodiments, the circular-bounded layer portion is of the inner layer. In other embodiments, the circular-bounded layer portion is of the outer layer. In some embodiments, the circular- bounded layer portion comprises a section of an inner layer of the proximal end of the cover, and wherein the proximal end of the cover further comprises an outer layer, the outer layer comprising a second twisted configuration in the braided wires in relation to the longitudinal axis. In some embodiments, the first twisted configuration in the braided wires in relation to the longitudinal axis comprises a first rotational direction, and wherein the second twisted configuration in the braided wires in relation to the longitudinal axis comprises a second rotational direction, opposite the first rotational direction. In some embodiments, the increased braid density comprises a reduction of at least 50% in the average hole size in a 1.5 mm inner diameter to 2.5 mm outer diameter ring of the circular -bounded layer portion the inner layer, wherein hole size is defined as (maximum axis plus transverse axis) / 2. In some embodiments, the increased braid density comprises a reduction of at least 70% in the average hole size in a 1.5 mm inner diameter to 2.5 mm outer diameter ring of the circular- bounded layer portion the inner layer, wherein hole size is defined as (maximum axis plus transverse axis) / 2.

[0046] A method for constructing an apparatus for treating an aneurysm in a blood vessel, according to an embodiment of the present disclosure, comprises creating a braided tube from a plurality of wires, each of the plurality of wires having a diameter of between 0.0005” and 0.0015”, the braided tube having a first end, a second end, and a longitudinal axis, inverting the braided tube to form an inner layer and an outer layer, forming a cover from the inner layer and the outer layer, the cover having a proximal end and a distal end, twisting one or both of the first end and / or the second end of the tube in relation to the longitudinal axis while restricting a portion of the braided tube from being twisted such that a braid density of a proximal portion of the cover is increased, and locking the twist in place. In someembodiments, locking the twist in place comprises securing the one or both of the first end and / or the second end of the tube in relation to the portion of the braided tube. In some embodiments, the securing comprises bonding with one or more of an adhesive, an epoxy, or a hot melt. In some embodiments, the securing comprises welding, brazing, and / or soldering. In some embodiments, twisting comprises creating a twist of between about 5° and about 270°. In some embodiments, the securing comprises welding, brazing, and / or soldering. In some embodiments, twisting comprises creating a twist of between about 5° and about 180°. In some embodiments, the securing comprises welding, brazing, and / or soldering. In some embodiments, twisting comprises creating a twist of between about 5° and about 90°. In some embodiments, the securing comprises welding, brazing, and / or soldering. In some embodiments, twisting comprises creating a twist of between about 5° and about 60°. In some embodiments, the securing comprises welding, brazing, and / or soldering. In some embodiments, twisting comprises creating a twist of between about 15° and about 50°.

[0047] In FIGS. 9-12, an aneurysm 10 having a neck portion 16 is shown. The occlusion device 100 is shown in use being implanted by a user (e.g., physician) into the aneurysm 10 through the delivery catheter 150 to disrupt or halt the flow of blood flow between the blood vessel 12 and the internal volume 14 of the aneurysm 10, thereby reducing the likelihood that the aneurysm 10 will rupture. Or, in cases in which the aneurysm 10 has already ruptured, the occlusion device 100 is being implanted to help heal the rupture and / or to prevent rerupture. The occlusion device 100 is configured to be low profile device, minimizing disruptions to surrounding bodies, such as a side branch 18 of the blood vessel 12. The blood vessel 12 has a blood vessel wall 13 and the aneurysm 10 has an aneurysm wall 11. In FIG. 9, the delivery catheter 150 is advanced through a sheath and / or guiding catheter (not shown) through a puncture or cutdown in a peripheral blood vessel, such as a femoral artery, a brachial artery, or a radial artery. The distal end 162 of the delivery catheter 150 can be shaped with a curve, as shown, either by the manufacturer, or prior to the procedure by the user, in order to allow for improved backup support when delivering the occlusion device 100, as well as to aid deliverability into the aneurysm 10. The distal end 162 of the delivery catheter 150 is placed adjacent the neck portion 16 of the aneurysm 10. The delivery catheter 150 can first be advanced over a guidewire (not shown) that is passed through the lumen 148. The guidewire can then be removed, leaving the lumen 148 as a delivery conduit and the delivery catheter 150 as a support column.

[0048] In FIG. 10, the occlusion device 100 is advanced through the lumen 148 of the delivery catheter 150, as described, and the distal end 118 of the occlusion device 100, havinga smooth apex 124 (of a curve in the tubular mesh 122) is advanced out of the lumen 148 and into the internal volume 14 of the aneurysm 10. The smooth apex 124 is the first portion of the occlusion device 100 that exits the lumen 148 and thus is the first portion of the occlusion device to enter the aneurysm 10. The smooth apex 124, because of is curved and contoured surface as well as its flexible mesh wall, is a blunt, soft, and atraumatic element that is configured to first contact the interior surface 15 of the aneurysm 10. The smooth apex 124 can contact the interior surface 15 and slide around the interior surface 15 is a less traumatic manner than most devices that are configured to implant into an aneurysm, such as small diameter detachable coils. The atraumatic characteristics of the smooth apex 124 make it fully deployable not only in unruptured cerebral aneurysms, but also in ruptured cerebral aneurysms, where certain other devices may be contraindicated. In FIG. 11, the occlusion device 100 is shown in a substantially expanded configuration within the internal volume 14 of the aneurysm 10. The cover 102 is expanded against the interior surface 15 of the aneurysm 10, and covers the neck portion 16 of the aneurysm. The tubular mesh 122 is expanded against the interior surface 15 of the aneurysm 10, at least at one or more portions, and serves to anchor or stabilize the cover 102 in the aneurysm 10 and adjacent the neck portion 16.

[0049] Also, in FIG. 11, the detachable joint 158 has been detached, and thus, the free end 154 of the pusher 152 can be pulled into the lumen 148 of the delivery catheter 150. In some embodiments, the delivery catheter 150 is maintained over the detachable joint 158 during the detachment procedure, to further protect the aneurysm 10. In FIG. 12, the delivery catheter 150 is removed, and the deployed occlusion device 100 is in place to begin to occlude the internal volume 14 of the aneurysm 10. The expanded tubular mesh 122 also serves to force the cover 102 against the neck portion 16 and / or against the interior surface 15, see straight arrow in FIG. 12. The dual layers of mesh in the cover 102 at the lower portion 107 (FIGS. 1 and 12), as well as the improvements described herein with the twist, aid in the disruption of blood flow into the aneurysm 10, thus causing thrombosis to isolate the internal volume 14 of the aneurysm 10 from blood flow through the blood vessel. 12. The force (straight arrow) maintaining the cover 102 in place further assures this process, and also protects against undesired compaction over time of the occlusion device 100, whether it be compaction in the longitudinal direction or compaction in a transverse or radial direction.

[0050] In alternative embodiments, the occlusion device 100 can be an occlusion device comprising a cover 102 but not comprising any doubled-over or looped tubular braided mesh 122. The occlusion device can in some embodiments consist of the cover 102. In otherembodiments, the occlusion device can comprise the cover 102 and a different type of internal anchor.

[0051] FIGS 13-14 illustrate a twisting fixture 300 comprising an elongate rigid tube 302 having a first end 304, a second end 306, and a lumen 308 extending therethrough. An elongate rigid mandrel 310, having a first end 312 and a second end 314, has an outer diameter that is less than the inner diameter of the lumen 308, and thus, the mandrel 310 is configured to be at least partially inserted through the lumen 308. The rigid tube 302 can also be referred to as a hollow mandrel. In some embodiments, the rigid tube 302 and the mandrel 310 each comprise stainless steel, or another high-strength, high-temperature (withstanding) material.

[0052] A base 316 has a distal end 318, a proximal end 320, and a lumen 322. The base 316 is configured to be placed on the first end 304 of the rigid tube 302, via the lumen 322. A spherical ball 324 has a lumen 326 therethrough and is configured to be slid over the outer diameter of the rigid tube 302. The base 316 and the ball 324 in some embodiments comprise brass, or another material with relatively high thermal conductivity (aluminum, copper, silver).

[0053] FIGS. 15-16 illustrate a cover 102' (of an occlusion device) that is constructed from a mesh (braided) Nitinol (nickel -titanium alloy) tube 105' that is inverted on itself. FIG. 15 shows the cover 102' by itself, and FIG. 16 shows the cover on the twisting fixture 300, in a first position. FIG. 15 is intended to provide additional clarity. The configuration of the cover 102' in FIGS. 15-16 is an intermediate configuration. In the final assembly configuration, the mesh tube 105' has a first end 104' that will be internal to a second end 106', a relationship similar to the first end 104 and second end 106 in FIGS. 1 and 3 (and alternative FIG. 4). However, in the intermediate configurations of FIGS. 15-16, the second end 106' is reverted (or incompletely inverted, depending on the particular assembly procedure and its status). Thus, the second end 106' is shown at the left of the figure and the first end 104' is shown at the right. The intermediate configuration allows easy, separated access to both of the first end 104' and the second end 106' at the same time, to allow each of them, or both of them, to be twisted around a longitudinal axis AL (in relation to the remainder of the cover 102').

[0054] In some embodiments, the cover 102' can be heat-formed over the base 316 and also twisted over the base 316. In other embodiment, the cover 102' can be heat formed over a different fixture and then twisted over the base 316. During a twisting procedure, the targetarea of the mesh tube 105' can be a portion 321 that will form an inner layer at the proximal end of the cover 102', for example, a portion that will be configured to cover the neck 16 of the aneurysm 10. After the twisting procedure, the second end 106' of the mesh tube 105' will be reoriented to be adjacent the first end 104' (e.g., at the right of the figure) and a portion 323 of the mesh tube 105' will now become an outer layer at the proximal end of the cover 102'. The ball 324 acts as a centering element of the twisting fixture 300, to maintain the cover 102' in its intermediate configuration centered over the twisting fixture 300.

[0055] FIGS. 17-18 illustrate an alternative twisting fixture 300' that incorporates a similar rigid tube 302 and rigid mandrel 310, but utilizes a single centering base 319 instead of the base 316 / centering ball 324 combination. FIG. 19 illustrates an alternative twisting fixture 300" that incorporates a similar rigid tube 302 and rigid mandrel 310 (not shown), but utilizes a single centering base 325 that includes wavy indentations 329 to allow secondary wavy shapes to be either heat-formed into the cover 102" and / or allow the base 325 to snugly hold the cover 102". Either way, FIG. 18 represents a pre-twisting portion of the process and FIG. 19 represents a twisting and post-twisting portion of the process, regardless of which configuration of the twisting fixture 300, 300', 300" is used and / or regardless of which cover 102, 102', 102" shape is formed.

[0056] In FIG. 18, a radiopaque marker band 328 is shown bonded to the inner layer 123" of the mesh tube 105". In FIG. 19, the outer layer 125" will take its place after the twisting is done and the outer layer 125" is inverted (or re-inverted). Some adhesive 327 is used in small amounts, to temporarily secure portions of the inner layer 123" to the outer surface of the rigid tube 302. These securements done at one or more window, for example two windows, three window, four windows. A ’’window” can comprise one or more openings (e.g., diamond shapes, in the mesh tube 105", or a forced-open diamond). In other embodiments, a thinwalled polymeric tube with one or more openings cut into it can be slid over the first end 104" of the mesh tube 105" in order to create the windows. The windows are represented in FIG. 18 by a first window 331 and a second window 333. In other embodiments, there may be a third window that is at the same axial position as the first window 331, but 180° opposite (e.g., in relation to the mandrel 310 or tube 302), and a fourth window that is at the same axial position as the second window 333, but 180° opposite. Instant adhesive, such as cyanoacrylate can be utilized as the adhesive 327, but in the embodiment shown in FIG. 18, an ultraviolet curable adhesive (UV adhesive) is utilized. Thus, the adhesive is added at thewindow 331, 333, and then the areas near the windows 331, 333, either at the same time or separately, are exposed to the UV light, curing the adhesive such that the mesh tube 105" inner layer is temporarily bonded to the rigid tube 302. Thus, rotation of the mesh tube 105" at this portion forces cooperative rotation of the rigid tube 302. This will allow the portion 321 of the mesh tube 105" to be twisted, and allow its wire density to be increased, as previously described. The portion 335 of the mesh tube 105" directly over the base 325 can be gripped or pinched (e.g., by the fingers or an operator, or by a fixture) in order to provide equal and opposite torsional resistance.

[0057] Prior to the twisting, some adhesive 327 is placed at point 335. This UV adhesive is intended to be cured and thus to be set (e.g., set up) after the twisting. Turning to FIG. 19, the portion 335 / base 325 is axially compressed toward the rigid tube 302 / bonded windows 331, 333 of the mesh tube 105" arrows 337, 339, and then the portion 335 / base 325 is rotated in relation to the rigid tube 302 / bonded windows 331, 333 of the mesh tube 105" and held (by an assembler / operator and / or or by a fixture / machine) at this particular rotational displacement angle. The adhesive 327 at point 335 is then cured and set, permanently maintaining the displacement angle. In some embodiments, the rotational displacement angle is between about 5° and about 270°, or between about 5° and about 180°, or between about 5° and about 90°, or between about 5° and about 60°, or between about 15° and about 50°. With the displacement angle maintained, the wire density at the portion 321 is increased, and the porosity at the portion 321 is decreased. The diamond spaces between the wires / filaments are thus deformed, compressed, twisted, and / or made smaller in area or smaller in space / wire separation. After the twisting procedure, the second end 106" of the mesh tube 105" will be reoriented to be adjacent the first end 104" (e.g., at the right of the figure) and a portion 323 (not shown) of the mesh tube 105" will now become an outer layer at the proximal end of the cover 102".

[0058] After the adhesive 327 is set in the portion 321, the mandrel 310 can be removed. In some embodiments, the portion 335 / base 325 and / or the rigid tube 302 is / are held and the mandrel 310 is torqued, to release it from the adhesive 327, and then the mandrel 310 is axially pulled and removed. In some embodiments, the mandrel 310 comprises a Teflon- coated mandrel, or a silicone coated mandrel, to increase release properties. Likewise, the window 331, 333 portions of the mesh tube 105" can be torqued to release from the rigid tube 302. In some embodiments, the rigid tube 302 comprises a Teflon-coated outer surface, or a silicone coated outer surface, to increase release properties.

[0059] The occlusion devices described herein can have a diameter of between about 3 mm and about 18 mm, or between about 4 mm and about 14 mm, and can have a length over between 3 mm and about 22 mm or between about 4 mm and about 18 mm. The occlusion devices described herein are intended for embolizing cerebral aneurysms, but may also be utilized for embolizing other types of aneurysms, or treating left atrial appendages or other openings.

[0060] The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “approximately”, “about”, and “substantially” as used herein include the recited numbers (e.g., about 10%=10%), and also represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount.

[0061] For purposes of the present disclosure and appended claims, the conjunction “or” is to be construed inclusively (e.g., “an apple or an orange” would be interpreted as “an apple, or an orange, or both”; e.g., “an apple, an orange, or an avocado” would be interpreted as “an apple, or an orange, or an avocado, or any two, or all three”), unless: (i) it is explicitly stated otherwise, e.g., by use of “either. . .or,” “only one of,” or similar language; or (ii) two or more of the listed alternatives are mutually exclusive within the particular context, in which case “or” would encompass only those combinations involving non-mutually-exclusive alternatives. For purposes of the present disclosure and appended claims, the words “comprising,” “including,” “having,” and variants thereof, wherever they appear, shall be construed as open-ended terminology, with the same meaning as if the phrase “at least” were appended after each instance thereof.

Claims

WHAT IS CLAIMED IS:

1. An implant comprising: a braided body configured for placement within a cerebral aneurysm and having a longitudinal axis, the braided body comprising a proximal face, at least an inner portion of the proximal face twisted around the longitudinal axis.

2. The implant of claim 1, wherein the proximal face is substantially transverse to the longitudinal axis.

3. The implant of claim 1, wherein the braided body comprises: a proximal cover having a distal concavity; and a curved tubular mesh having an apex that extends from the distal concavity of the proximal cover.

4. The implant of claim 3, wherein the tubular mesh comprises a braided tube.

5. The implant of claim 1, wherein the braided body comprises a braided tube that is inverted on itself.

6. The implant of claim 5, wherein the braided tube comprises a low profile first end and a peripheral portion radially spaced from the first end, the first end and peripheral portion located at or adjacent to a proximal end of the braided body.

7. The implant of claim 6, wherein the first end is maintained in a rotated position in relation to the peripheral portion.

8. The implant of claim 7, further comprising a securing agent statically coupling the first end in relation to the peripheral portion to maintain the at least an inner portion of the proximal face in a twisted configuration.

9. The implant of claim 8, wherein the securing agent comprises one or more material selected from the list consisting of: an adhesive, an epoxy, a hot melt, a braze, a solder, and a welded portion of the first and second ends.

10. The implant of claim 1, wherein the at least an inner portion of the proximal face carries at least some of the securing agent.

11. The implant of claim 1, wherein the proximal face comprises a circular- bounded layer portion comprising a first twisted configuration of braided wires in relation to the longitudinal axis as compared to an untwisted configuration.

12. The implant of claim 11, wherein the circular-bounded layer portion comprises a 25% or more increased braid density as compared to the untwisted configuration, wherein the at least an inner portion of the proximal face is not twisted around the longitudinal axis.

13. The implant of claim 11, wherein the circular-bounded layer portion comprises a 50% or more increased braid density as compared to the untwisted configuration, wherein the at least an inner portion of the proximal face is not twisted around the longitudinal axis.

14. The implant of claim 11, wherein the circular-bounded layer portion comprises a 25% to 85% increased braid density as compared to the untwisted configuration, wherein the at least an inner portion of the proximal face is not twisted around the longitudinal axis.

15. The implant of claim 11, wherein the circular-bounded layer portion comprises a 75% or more increased braid density as compared to the untwisted configuration, wherein the at least an inner portion of the proximal face it not twisted around the longitudinal axis.

16. An apparatus for treating an aneurysm in a blood vessel, comprising: an occlusion device comprising: a cover having a proximal end and a distal end and comprising a tube constructed of braided wires, wherein the tube is inverted on itself, the tube having a proximal end, a distal end, and a longitudinal axis, wherein the cover comprises a circular- bounded layer portion at or adjacent the proximal end of the cover, the circular-bounded layer portion comprising a first twisted configuration in the braided wires in relation to the longitudinal axis, the circular-bounded layer portion comprising an increased braid density as compared to an untwisted configuration.

17. The apparatus of claim 16, wherein the proximal end of the cover comprises an inner layer and an outer layer of the tube.

18. The apparatus of claim 17, wherein the circular-bounded layer portion is of the inner layer.

19. The apparatus of claim 17, wherein the circular bounded layer portion is of the outer layer.

20. The apparatus of claim 16, wherein the circular-bounded layer portion comprises a section of an inner layer of the proximal end of the cover, and wherein the proximal end of the cover further comprises an outer layer, the outer layer comprising a second twisted configuration in the braided wires in relation to the longitudinal axis.

21. The apparatus of claim 20, wherein the first twisted configuration in the braided wires in relation to the longitudinal axis comprises a first rotational direction, andwherein the second twisted configuration in the braided wires in relation to the longitudinal axis comprises a second rotational direction, opposite the first rotational direction.

22. The apparatus of any one of claims 17-19, wherein the increased braid density comprises a reduction of at least 50% in an average hole size in a 1.5 mm inner diameter to 2.5 mm outer diameter ring of the circular-bounded layer portion, wherein hole size is defined as (maximum axis plus transverse axis) / 2.

23. The apparatus of claim 22, wherein the increased braid density comprises a reduction of at least 70% in the average hole size.

24. The apparatus of any one of claims 16-23, wherein the first twisted configuration in the braided wires in relation to the longitudinal axis comprises a twist of between about 5° and about 270°.

25. The apparatus of any one of claims 16-23, wherein the first twisted configuration in the braided wires in relation to the longitudinal axis comprises a twist of between about 5° and about 180°.

26. The apparatus of any one of claims 16-23, wherein the first twisted configuration in the braided wires in relation to the longitudinal axis comprises a twist of between about 5° and about 90°.

27. The apparatus of any one of claims 16-23, wherein the first twisted configuration in the braided wires in relation to the longitudinal axis comprises a twist of between about 5° and about 60°.

28. The apparatus of any one of claims 16-23, wherein the first twisted configuration in the braided wires in relation to the longitudinal axis comprises a twist of between about 15° and about 50°.

29. The apparatus of any one of claims 16-28, wherein the wires each have a diameter of between about 0.0005” and about 0.00125”.

30. The apparatus of any one of claims 16-28, wherein the wires each have a diameter of between about 0.0005” and about 0.001”.

31. The apparatus of any one of claims 16-30, wherein the wires comprise a nickel -titanium alloy.

32. The apparatus of any one of claims 16-31, wherein at least some of the wires comprise drawn filled tubes (DFT).

33. The apparatus of any one of claims 16-32, wherein the proximal end and the distal end of the tube are at or adjacent the proximal end of the cover.

34. The apparatus of any one of claims 16-33, wherein the inversion of the tube begins at the distal end of the cover.

35. The apparatus of any one of claims 16-34, further comprising a delivery shaft configured to be coupled to the occlusion device.

36. The apparatus of claim 35, wherein the delivery shaft is detachably coupled to the occlusion device.

37. The apparatus of any one of claims 16-36, wherein the occlusion device further comprises an inner anchor coupled to the cover and configured to extend distally of the cover.

38. The apparatus of claim 37, wherein at least a distal portion of the inner anchor is configured to contact an interior surface of an aneurysm when the cover internally covers a neck portion of the aneurysm.

39. A method for delivering the occlusion device of any one of claims 16-38, comprising: inserting the occlusion device through the lumen of a delivery catheter such that the occlusion device exits the lumen of the delivery catheter at a distal end of the delivery catheter; and implanting the occlusion device within a cerebral aneurysm.

40. The method of claim 39, wherein implanting the occlusion device comprises allowing the occlusion device to expand from a collapsed configuration toward an expanded configuration.

41. A method of constructing an apparatus for treating an aneurysm in a blood vessel, comprising: creating a braided tube from a plurality of wires, each of the plurality of wires having a diameter of between 0.0005” and 0.0015”, the braided tube having a first end, a second end, and a longitudinal axis; inverting the braided tube to form an inner layer and an outer layer; forming a cover from the inner layer and the outer layer, the cover having a proximal end and a distal end; twisting one or both of the first end and / or the second end of the braided tube in relation to the longitudinal axis while restricting a portion of the braided tube from being twisted such that a braid density of a proximal portion of the cover is increased at a twisted area; and locking the twisted area in place.

42. The method of claim 41, wherein locking the twisted area in place comprises securing the one or both of the first end and / or the second end of the braided tube in relation to the portion of the braided tube.

43. The method of claim 42, wherein the securing comprises bonding with an adhesive.

44. The method of claim 42, wherein the securing comprises bonding with an epoxy.

45. The method of claim 42, wherein the securing comprises bonding with a hot melt.

46. The method of claim 42, wherein the securing comprises welding.

47. The method of claim 42, wherein the securing comprises brazing.

48. The method of claim 42, wherein the securing comprises soldering.

49. The method of any one of claims 41-48, wherein the increased braid density comprises a reduction of at least 50% in an average hole size in a 1.5 mm inner diameter to 2.5 mm outer diameter ring of a circular-bounded layer portion at or adjacent the proximal end of the cover, wherein hole size is defined as (maximum axis plus transverse axis) / 2.

50. The apparatus of claim 49, wherein the increased braid density comprises a reduction of at least 70% in the average hole size.

51. The method of any one of claims 41-50, wherein locking the twisted area in place comprises locking in a rotation of between about 5° and about 270°.

52. The method of any one of claims 41-50, wherein locking the twisted area in place comprises locking in a rotation of between about 5° and about 180°.

53. The method of any one of claims 41-50, wherein locking the twisted area in place comprises locking in a rotation of between about 5° and about 90°.

54. The method of any one of claims 41-50, wherein locking the twisted area in place comprises locking in a rotation of between about 5° and about 60°.

55. The method of any one of claims 41-50, wherein locking the twisted area in place comprises locking in a rotation of between about 15° and about 50°.

56. The method of any one of claims 41-55, wherein twisting one or both of the first end and / or the second end of the tube comprises utilizing a twisting fixture.

57. The method of claim 56, wherein the twisting fixture comprises an elongate rigid tube having a lumen, an elongate rigid mandrel configured to be at least partially placed within the lumen, and a base, the base configured to hold the formed cover.

58. The method of claim 57, wherein the twisting fixture further comprises a centering element.

59. The method of claim 58, wherein the centering element comprises a spherical shape.

60. The method of either one of claims 58 or 59, wherein the centering element has a centering element lumen and is configured to be slid over the rigid tube.

61. The method of claim 60, wherein the base has a base lumen and is configured to be slid over the mandrel.

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