Inverting braided aneurysm treatment system and method

An example system can include a tubular braid, a catheter, and an embolic coil. The tubular braid can have an open end, a pinched end, and a predetermined shape. In the predetermined shape, the tubular braid can have two inversions and a middle segment extending between the two inversions that forms a sack. The tubular braid can be implanted in an implanted shape based on the predetermined shape. A distal end of the catheter can be inserted into the sack when the tubular braid is implanted. The embolic coil can be delivered through the catheter into the sack. The opening to the sack can correspond to a constricted columnar segment of the middle segment when the braid is in the predetermined shape.

FIELD OF INVENTION

The present invention generally relates to medical instruments, and more particularly, to embolic implants for aneurysm therapy.

BACKGROUND

Cranial aneurysms can be complicated and difficult to treat due to their proximity to critical brain tissues. Prior solutions have included endovascular treatment whereby an internal volume of the aneurysm sac is removed or excluded from arterial blood pressure and flow. Current alternatives to endovascular or other surgical approaches can include intravascularly delivered treatment devices that fill the sac of the aneurysm with embolic material or block the entrance or neck of the aneurysm. Both approaches attempt to prevent blood flow into the aneurysm. When filling an aneurysm sac, the embolic material clots the blood, creating a thrombotic mass within the aneurysm. When treating the aneurysm neck, blood flow into the entrance of the aneurysm is inhibited, inducing venous stasis in the aneurysm and facilitating a natural formation of a thrombotic mass within the aneurysm.

Current intravascularly delivered devices typically utilize multiple embolic coils to either fill the sac or treat the entrance of the aneurysm. Naturally formed thrombotic masses formed by treating the entrance with embolic coils can result in improved healing compared to aneurysm masses packed with embolic coils because naturally formed thrombotic masses can reduce the likelihood of distention from arterial walls and facilitate reintegration into the original parent vessel shape along the neck plane. However, embolic coils delivered to the neck of the aneurysm can potentially have the adverse effect of impeding the flow of blood in the adjoining blood vessel, particularly if the entrance is overpacked. Conversely, if the entrance is insufficiently packed, blood flow can persist into the aneurysm. Treating certain aneurysm morphology (e.g. wide neck, bifurcation, etc.) can require ancillary devices such a stents or balloons to support the coil mass and obtain the desired packing density. Once implanted, the coils cannot easily be retracted or repositioned. Furthermore, embolic coils do not always effectively treat aneurysms as aneurysms treated with multiple coils often recanalize or compact because of poor coiling, lack of coverage across the aneurysm neck, blood flow, or large aneurysm size.

Alternatives to embolic coils are being explored, for example a tubular braided implant is disclosed in U.S. Pat. No. 10,751,066, incorporated herein by reference. Tubular braided implants have the potential to easily, accurately, and safely treat an aneurysm or other arterio-venous malformation in a parent vessel without blocking flow into perforator vessels communicating with the parent vessel. Compared to embolic coils, however, tubular braided implants are a newer technology, and there is therefore capacity for improved geometries, configurations, delivery systems, etc. for the tubular braided implants.

There is therefore a need for improved methods, devices, and systems for implants for aneurysm treatment.

SUMMARY

An example system can include a tubular braid, a catheter, and an embolic coil. The tubular braid can have an open end, a pinched end, and a predetermined shape. In the predetermined shape the braid can have a first segment extending from the open end to a first inversion, a second segment extending from the first inversion to the second inversion, and a third segment surrounded by the second segment and extending from the second inversion to the pinched end. The second segment can form a sack having an opening approximate the first inversion. The catheter can have a lumen therethrough, a distal end, and an outer diameter at the distal end that is sized to be inserted into the sack through the opening of the sack. The embolic coil is detached from the tubular braid and is positioned within the lumen. The embolic coil is configured to exit the distal end of the catheter.

The tubular braid can be stable in an implanted shape, that is based on the predetermined shape, when the tubular braid is constricted by a substantially spherical cavity. In the implanted shape, at least a portion of the first segment can be positioned to contact a cavity wall of the substantially spherical cavity, a proximal inversion corresponding to the first inversion of the predetermined shape can be positioned at an entrance to the substantially spherical cavity, the sack can be positioned within the substantially spherical cavity, the opening of the sack can be accessible at the entrance to the substantially spherical cavity, and the opening can be configured to receive the distal end of the catheter into the sack. In the implanted shape, the braid can have pores near the proximal conversion that are sized such that the catheter can pass through one of the pore so that the distal end of the catheter is positioned between the first segment and the sack.

In the implanted shape, the opening can be resilient to expand to receive the distal end of the catheter and contract when the catheter is removed from the opening.

The embolic coil can be sized to fit within the sack when the tubular braid is in the implanted shape.

In the predetermined shape, the tubular braid can be cylindrically symmetrical about a central axis and the second segment can include a columnar section extending in a proximal direction from the sack, constricted about the central axis, and defining the opening of the sack.

In the predetermined shape, the second segment can include a bend of approximately 90° separating the sack from the columnar section.

A diameter of the columnar section when the braid is in the predetermined shaped can collapse when the braid is in the implanted shape.

The columnar section can be columnar in shape when the tubular braid is in the implanted shape.

The outer profile of the tubular braid in the predetermined shape can be approximately a right cylinder. Alternatively, the outer profile of the tubular braid in the predetermined shape can be approximately pear shaped.

An example tubular braid of an aneurysm implant can have an open end and a pinched end. The tubular braid can have a predetermined shape and an implanted shape in which the tubular braid is stable when constricted by a substantially spherical cavity.

In the predetermined shape the braid can have a first segment extending from the open end to a first inversion, a second segment extending from the first inversion to the second inversion and forming a sack comprising an opening approximate the first inversion, and a third segment surrounded by the second segment and extending from the second inversion to the pinched end. The implanted shape can be based on the predetermined shape. In the predetermined shape, the tubular braid can be cylindrically symmetrical about a central axis and the second segment can include a columnar section extending in a proximal direction from the sack, constricted about the central axis, and defining the opening of the sack.

In the implanted shape at least a portion of the first segment can be positioned to contact a cavity wall of the substantially spherical cavity, a proximal inversion corresponding to the first inversion of the predetermined shape can be positioned at an entrance to the substantially spherical cavity, the sack can be positioned within the substantially spherical cavity, and the opening of the sack is twisted to thereby inhibit access to the sack via the opening. In the implanted shape, the columnar section can be twisted about the central axis.

An example method of treating an aneurysm can include any combination of the steps presented as follows in no particular and can include additional steps not presented herein. A braid can be delivered, in a delivery configuration, via attachment to a delivery system, through a catheter. The braid can include an outer surface in the delivery configuration. A braid sack can be created within an aneurysm sac such that the braided sack includes an interior surface that corresponds to an exterior surface of the braid in the delivery configuration. The braid can be detached from the delivery system, thereby implanting the braid in an implanted shape within the aneurysm sac. After detaching the braid from the delivery system, an embolic coil can be inserted into the braided sack.

The method can further include apposing a first portion of the braid to an aneurysm wall. The method can further include creating a proximal inversion by inverting the braid approximate an aneurysm neck. The method can further include creating a distal inversion by inverting the braid within the aneurysm sac so that the braided sack extends between the proximal inversion and the distal inversion.

The method can further include encircling the braided sack with an open end of the first portion while the braid is within the aneurysm sac in the implanted shape.

The braid can be implanted such that implanted shape is based in part on a predetermined shape of the braid and based in part on the geometry of the aneurysm sac.

The braid can be implanted such that the proximal inversion and the distal inversion correspond to respective inversions of the braid when the braid is in the predetermined shape.

The method can further include allowing the braid to self-anchor within the aneurysm after detaching the braid from the delivery system.

The method can further include expanding the braided sack with the embolic coil.

Detaching the braid from the delivery system can further include releasing a pinched end of the braid from the delivery system so that the pinched end is suspended within the braided sack. Alternatively, detaching the braid from the delivery system can further include releasing a pinched end of the braid from the delivery system so that the pinched end is positioned approximate a plane defined by the aneurysm neck.

The braid can be delivered in the delivery configuration such that, a pinched end of the braid is in contact with the delivery system and the braid extends in a single layer tubular shape in a distal direction from the pinched end to a distal open end of the braid.

DETAILED DESCRIPTION

Examples presented herein generally include a braided implant that can secure within an aneurysm sac and occlude a majority of the aneurysm's neck. The implant can include a tubular braid that can be set into a predetermined shape, compressed for delivery through a microcatheter, and implanted in at least one implanted position that is based on the predetermined shape and the geometry of the aneurysm in which the braid is implanted.

FIGS. 1A through 1Care illustrations of an example braided implant100that can have a predetermined shape as illustrated inFIG. 1Aand two distinct implanted shapes as illustrated inFIGS. 1B and 1C. The implant100can treat a range of aneurysm sizes including a larger aneurysm10aas illustrated inFIG. 1Band a smaller aneurysm10bas illustrated inFIG. 1C. The implant100can have a first implanted shape (FIG. 1B) that can be conducive for treating larger aneurysms10aand a second implanted shape (FIG. 1C) that can be conducive for treating smaller aneurysms10b. The implant100can include a tubular braid110having an open end114and a pinched end112. The implant100can include a detachment feature150attached to the braid110at the pinched end112. The tubular braid110can be formed in the predetermined shape (FIG. 1A), collapsed for delivery through a microcatheter, attached to a delivery system at the detachment feature150, and implanted in a shape similar to one or the other of the two implanted shapes (FIG. 1BorFIG. 1C).

Referring toFIG. 1A, when in the predetermined shape, the tubular braid110can include two inversions122,124, dividing the braid110into three segments142,144,146. In the predetermined shape, the braid110can have an outer segment142extending from the open end114of the braid110to one of the inversions122, an inner segment146extending from the pinched end112of the braid110to the other of the inversions124, and a middle segment144extending between the two inversions122,124. When in the predetermined shape, the tubular braid110can be substantially radially symmetrical about a central vertical axis y (seeFIG. 6A).FIG. 1Aillustrates a profile of each segment142,144,146, and the detachment feature150is illustrated as a flat key that can be used with a mechanical implant delivery system (not illustrated).

The tubular braid110can be formed into the predetermined shape by first inverting the braid outwardly to separate the inner segment146from the middle segment144with an inversion124, then the middle segment144can be shaped over a form to produce the substantially “S” shaped profile illustrated, and finally, the braid110can be inverted outwardly again to separate the middle segment144from the outer segment142with another inversion122. If necessary, the braid can be trimmed at the open end114. The open end114can be positioned to encircle the middle segment144. The open end114can positioned within the middle third section of the braid's height as illustrated.

It can be advantageous to minimize a neck opening126defined by the lower extension of the “S” shape of the middle segment144to maximize occlusion of an aneurysm neck when the implant100is implanted. The middle segment144can have one or more bends132,134. The bends132,134can be positioned facilitate the movement of the braid110into the second implanted shape illustrated inFIG. 1Cand the bends132,134can be positioned to stabilize the braid110in the first and/or second implanted shape.

The tubular braid110can include memory shape material that can be heat set to a predetermined shape, can be deformed for delivery through a catheter, and can self-expand to an implanted shape that is based on the predetermined shape and confined by the anatomy of the aneurysm in which it is implanted.

As illustrated inFIG. 1B, when in the first implanted shape, the braid110can have an outer layer142acontacting the aneurysm's wall14a, a sack144anested within the outer layer142a, a proximal inversion122apositioned at the aneurysm's neck16a, and a distal inversion124apositioned near a distal portion15aof the aneurysm wall14a. In the first implanted shape, the detachment feature150and pinched end112of the braid110can be suspended within the sack144a.

As illustrated inFIGS. 1A and 1B, the tubular braid110in the first implanted shape can be radially compressed and vertically extended compared to the predetermined shape. The outer layer142ain the first implanted shape can correspond to the outer layer142in the predetermined shape, the proximal inversion122ain the first implanted shape can correspond to the inversion122adjacent to the outer layer142in the predetermined shape, the sack144ain the first implanted shape can correspond to the middle segment144in the predetermined shape, the distal inversion124ain the first implanted shape can correspond to the inversion124adjacent to the inner segment146in the predetermined shape, and an inner braid segment146asuspending the detachment feature150in the first implanted shape can correspond to the inner segment146in the predetermined shape. In the first implanted shape, the sack144acan have a neck opening126acorresponding to the neck opening126in the predetermined shape.

As illustrated inFIG. 1C, when in the second implanted shape, the braid110can have an outer layer142bcontacting the aneurysm's wall14b, a proximal inversion122bpositioned at the aneurysm's neck16b, a middle layer144bextending within the outer layer142band pressing against the outer layer142b, a distal inversion124bpositioned near the open end114of the braid110, and an inner layer146bextending within the middle layer144band pressing against the middle layer144b. In the second implanted shape, the detachment feature150and pinched end112of the braid110can be positioned at the aneurysm neck16b, near the proximal inversion122b.

As illustrated inFIGS. 1A and 1C, the tubular braid110in the second implanted shape can be radially compressed compared to the predetermined shape, and the middle segment144of the predetermined shape can be folded so that the height of the tubular braid110is compressed in the second implanted shape compared to the predetermined shape.

Alternatively, when implanted in the second implanted shape in aneurysms having a diameter that is significantly smaller than the aneurysm's height, the second implanted shape can be radially compressed compared to the predetermined shape and the height of the braid in the second implanted shape can be greater than the height of the braid in the predetermined shape.

The outer layer142bin the second implanted shape can correspond to the outer layer142in the predetermined shape, the proximal inversion122bin the second implanted shape can correspond to the inversion122adjacent to the outer layer142in the predetermined shape, the middle layer144band inner layer146bin the second implanted shape can correspond to the middle segment144in the predetermined shape, the distal inversion124bin the second implanted shape can correspond to a bend134in the middle segment144in the predetermined shape, and a portion of the braid110near the detachment feature150forming the inner layer146bin the second implanted shape can correspond to the inner segment146in the predetermined shape.

FIGS. 2A through 2Hare illustrations of an example implant100having a braid110expanding to a predetermined shape as the braid110exits a microcatheter600. The implant100has a predetermined shape similar to as illustrated inFIG. 1A. As illustrated inFIG. 2A, the braid110can be shaped to a delivery shape that is extended to a single layer of tubular braid having a compressed circumference/diameter sized to be delivered through the microcatheter600and a length L. The illustrated implant100has a length L of between about 22 mm and about 25 mm. As will be appreciated and understood by a person of ordinary skill in the art, the length L of a specific braid110can be tailored based on the size and shape of the aneurysm being treated.

During delivery through the microcatheter600, the detachment feature150can be attached to a delivery system at a proximal end of the implant100, the pinched end112can be positioned near the proximal end of the implant100, and the open end114can define the distal end of the implant100. Collapsing the braid110to a single layer tube can result in a braid110that has a sufficiently small diameter and a sufficiently short length L to mitigate effects of friction force on the braid110when it is delivered through the microcatheter, allowing the braid110to be delivered unsheathed in some applications.

As illustrated inFIG. 2B, the open end114can be positioned to exit the microcatheter600before any other portion of the braid110exits the microcatheter. The open end114can expand as it exits the microcatheter600. If the open end114is unconstrained by an aneurysm as illustrated, the open end can expand to its circumference in the predetermined shape.

As illustrated inFIG. 2C, the distal portion of the braid110can continue to expand radially as it exits the microcatheter600.

As illustrated inFIG. 2D, the braid110can form the inversion122defining the outer segment142as the braid110is further pushed out of the microcatheter600.

As illustrated inFIGS. 2E through 2G, the “S” shape of the middle segment144can begin to form as the braid110is further pushed from the microcatheter600.

As illustrated inFIG. 2H, when all, or nearly all of the braid110exits the microcatheter600, the braid110, not confined by an aneurysm, can expand to a predetermined shape similar to the shape illustrated inFIG. 1A. In the predetermined shape, the braid110of the illustrated implant has a diameter between about 6 mm and about 6.5 mm and a height between about 5 mm and about 5.5 mm.

The ratio of the outermost diameter of the braid110in the predetermined shape illustrated inFIG. 2Hto the length of the braid110in the delivery shape illustrated inFIG. 2Ais between about 0.3 and about 0.24.

FIGS. 3A through 3Hare illustrations of the implant100illustrated inFIGS. 2A through 2Hexpanding within an aneurysm10in two different implanted shapes. The aneurysm10has a height of about 6 mm, a diameter of about 6 mm, and a neck diameter of about 4 mm. Comparing the dimensions of the aneurysm10to the braid110in the predetermined shape illustrated inFIG. 2H, the braid110has a slightly larger diameter and a slightly smaller height, and the interior of the aneurysm10is substantially spherical while the outer dimensions of the braid110are more cylindrical (seeFIGS. 6A and 6Bfor measurement orientation). When the braid110of the implant100is confined by the aneurysm10, the braid110is therefore be radially constrained.

As illustrated inFIG. 3A, the implant100can be delivered to the aneurysm10through the microcatheter600, as described in relation toFIG. 2A. The open end114of the tubular braid110can expand within the aneurysm10as it exits the microcatheter600. The illustrated aneurysm10is positioned at a bifurcation including a stem blood vessel20and two branch vessels22a,22b, and the microcatheter600is illustrated being delivered through the stem blood vessel20. It is contemplated that the implant could be delivered to an aneurysm on a sidewall of a blood vessel through a curved microcatheter, and such a procedure is intended to be embraced by the scope of the present disclosure.

As illustrated inFIG. 3B, as the braid110is further pushed distally from the microcatheter600, the braid110can expand to appose the aneurysm wall14and conform to the aneurysm neck16. The aneurysm10being treated can have a diameter that is less than the outer diameter of the tubular braid110in the predetermined shape so that the braid110tends to expand outwardly, providing a force against the aneurysm wall14, and sealing around the perimeter of the aneurysm neck16. The implant100can be particularly suitable for treating a wide neck aneurysm such as commonly occur at bifurcations because the radial force provided by the braid110against the aneurysm wall14and perimeter of the neck16can be sufficient to both anchor the implant100in a wide neck aneurysm and seal the neck16of the aneurysm10.

As illustrated inFIG. 3C, as the braid110is further pushed distally from the microcatheter600, the proximal inversion122acan be formed.

As illustrated inFIG. 3D, the microcatheter600can be manipulated to place the proximal inversion122aat the aneurysm neck16. The proximal inversion122acan be placed on a proximal side of a plane defining a boundary18(SeeFIG. 6B) between the aneurysm10and the branch vessels22a,22b. In some applications it can be advantageous to place the proximal inversion122afar enough in the proximal direction from the plane18so that the outer layer142aof the braid110seals around the outer perimeter of the aneurysm neck16, but not so far proximally that the implant100becomes an obstruction to the blood vessels22a,22b,20.

As illustrated inFIG. 3E, the braid110can expand within the aneurysm sac12and extend to appose an inner surface of the outer layer142aof the braid110. The apposition to the outer layer142acan provide additional force to anchor the outer layer142ato the aneurysm wall14.

As illustrated inFIG. 3F, the aneurysm10has a height that can accommodate the tubular braid110in the first implanted shape similar to that illustrated inFIG. 1B. Because the braid110is radially constrained and has a more cylindrical shape compared to the substantially spherical shape of the aneurysm, the braid110can extend beyond the height of the predetermined shape to accommodate aneurysms taller than the predetermined shape. In the illustration, the tubular braid110of the implant100in the predetermined shape has a height between about 0.5 mm and 1 mm less than the height of the aneurysm, or in other words, the implant has extended between about 10% and about 20% in height in the first implanted shape compared to the predetermined shape.

The braid can be pulled proximally as illustrated inFIG. 3Gto form a second implanted shape as illustrated inFIG. 3Hthat is similar to the second implanted shape illustrated inFIG. 1C, but different in that the aneurysm10billustrated inFIG. 1Cis smaller (proportionally compared to the braid110) than the mock aneurysm10illustrated inFIG. 3H. Before the implant100is released from the delivery system, the implant100can be partially or fully retracted into the microcatheter600and repositioned in either of the first implanted shape or the second implanted shape. Additionally, or alternatively, the microcatheter600can be moved distally to move the braid110from the second implanted shape illustrated inFIG. 3Hto the first implanted shape illustrated inFIG. 3F. In some applications, while positioning the implant100, a physician can choose whether the first implanted shape or the second implanted shape is more suitable for the anatomy of the aneurysm and treatment site. For treatments involving aneurysms and implants shaped similar to the aneurysm10and implant100illustrated inFIGS. 3A through 3H, it can be more advantageous to shape the braid110in the first implanted shape as illustrated inFIG. 3F(rather than the second implanted shape illustrated inFIG. 3G) because the first implanted shape in this example implementation provides a larger surface area of the braid110in contact with the aneurysm wall14.

FIGS. 4A and 4Bare illustrations of the braid110of the example implant illustrated inFIGS. 2A through 2H and 3A through 3Hshowing the tubular braid110expanded within tubes to determine a range of aneurysm diameters and aneurysm heights that an implant100having the dimensions of the example implant100would be suitable for treating.FIG. 4Aillustrates the braid110in a tube having a 5 mm diameter. The braid110is in the first implanted shape and has a height of about 8 mm. The braid110is therefore radially constrained from its predetermined shape by between about 1 mm and 1.5 mm in diameter, or between about 17% and 23%, and expanded vertically in height by between about 2.5 mm and 3 mm, or between about 45% and 60%.

FIG. 4Billustrates the braid110in a tube having a 4 mm diameter. The braid110is in the second implanted shape and has a height of about 6 mm. The braid is therefore radially constrained from its predetermined shape by between about 2 mm and 2.5 mm in diameter, or between about 33% and 38%, and expanded vertically between about 0.5 mm and 1 mm, or between about 10% and 20%.

Implants having a predetermined shape and dimensions as illustrated and described in relation toFIG. 2Hcan therefore be suitable for treating aneurysms having a diameter between and including about 4 mm and about 5 mm and a height between and including about 6 mm and about 8 mm. As illustrated inFIG. 3F, the implant can also be suitable for treating an aneurysm having a diameter of 6 mm and a height of 6 mm. As will be appreciated and understood by a person of ordinary skill in the art, the dimensions of the tubular braid in the predetermined shape can be tailored to treat aneurysms within a range of sizes not specifically outlined herein according to the principles described herein. It is contemplated that a collection of implants so shaped can be made available to physicians, and a physician can choose a suitable implant from the collection based on aneurysm height, diameter, neck diameter, and/or other anatomical features.

A collection of implants, each having a uniquely shaped tubular braid can be created to provide a catalogue of implants for treating aneurysms ranging in diameter and height. The catalogue can include implants suitable for treating aneurysms ranging from 3 mm to 15 mm in diameter and ranging from 3 mm to 15 mm in height, or in another example, ranging from 3 to 11 mm in diameter and 3 to 7 mm in height. As will be appreciated and understood by a person of ordinary skill in the art, some aneurysm dimensions are extremely rare, and the catalog need not include implants for treating aneurysms having a large height:diameter ratio or a large diameter:height ratio.

Each implant in the collection can be suitable for treating aneurysms with a sub range of diameters and a sub-range of heights. An example catalogue can include a listing of implants for treating aneurysms of one or more of, but not limited to, the following size sub ranges (diameter range in mm, height range in mm): (3-5, 3-5), (6-8, 4-5), and (9-11, 5-7).

In some examples, each size sub range can be treated by a single implant having a tubular braid uniquely sized and shaped to be suitable for treating aneurysms within that sub range. In some examples, the sub ranges in the catalogue can be represented by implants each having a tubular braid with a delivery length (length when the braid is collapsed for delivery through a microcatheter) that is about 10 mm, about 40 mm, and/or including a length in between.

As will be appreciated and understood by a person of ordinary skill in the art, aneurysm height and diameter are measured with some margin of error. To that end, the size sub range included in the catalogue for a given implant can represent a portion of aneurysm sizes that can be treated with the implant and the implant can treat aneurysms outside of the listed sub range. For instance, an implant listed for treating aneurysms having heights between height a and height b and diameter range between diameter x and diameter y can be suitable for treating aneurysms slightly taller than the maximum listed height b if the diameter of the aneurysm is near the lower limit of the range (about diameter x), the implant can be suitable for treating diameters slightly larger than diameter y if the height of the aneurysm is near the lower limit of the height range (about height a).

FIGS. 5A through 5Dare illustrations of the example implant100as illustrated inFIGS. 1A through 1Cimplanted in either the first implanted shape or the second implanted shape in aneurysms ranging in size.FIG. 5Aillustrates a large aneurysm10a,FIGS. 5B and 5Cillustrate a medium aneurysm10c, andFIG. 5Dillustrates a small aneurysm10b. The implant100is advantageously implanted in an aneurysm10a,10b,10chaving a diameter about equal to or smaller than the diameter of the braid110in the predetermined shape so that the braid110provides an outward force F against the aneurysm wall14when implanted. The braid110can have inner layers that press against one or more outer layers, contributing to the force F.

As illustrated inFIG. 5A, the maximum size of an aneurysm10athat the implant100can be suitable for treating can be determined by the dimensions that the braid110can take in the first implanted shape. The pinched end112and detachment feature150can be positioned near a distal portion15aof the aneurysm wall14aas similarly illustrated inFIG. 1B.

As illustrated inFIG. 5B, the implant100can also be suitable for treating a medium sized aneurysm10cthat is smaller than the aneurysm10aillustrated inFIG. 5Ain the first implanted shape. To fit within the medium aneurysm10cin the first implanted shape, the pinched end112and detachment feature150can be positioned away from the distal portion15cof the aneurysm wall compared to the position of the pinched end112and detachment feature150in the large aneurysm10a. In the predetermined shape (seeFIG. 1A), the middle segment144can include a bend134to stabilize the tubular braid110in the first implanted shape in the medium aneurysm10cas illustrated inFIG. 5B.

As illustrated inFIG. 5C, the implant100can also be suitable for treating the medium sized aneurysm10cin the second implanted shape. The middle segment144of the braid in the predetermined shape (seeFIG. 1A) can be folded to form a middle layer144band an inner layer146bsimilar to as described in relation toFIG. 1C. In some applications, either implanted shape could be effective for treating the aneurysm10c, and a physician can select a preferred shape during treatment. For instance, a physician can decide to use the first implanted shape (FIG. 5B) to elongate the implant so that the proximal fold122acan be placed proximally outside of the aneurysm neck, or the physician can decide to use the second implanted shape (FIG. 5C) to provide more layers of braid at the aneurysm neck to occlude the neck opening16c.

As illustrated inFIG. 5D, the minimum size of aneurysm10bthat the implant100can be suitable for treating can be determined by the dimensions that the braid110can take in the second implanted shape. The open end114and/or the distal fold124bcan be collapsed near a distal portion15bof the aneurysm wall in the second implanted shape.

FIG. 6Ais an illustration of height HI and diameter D1, D2measurements of an example implant100in a predetermined shape. In the predetermined shape, the braid110of the example implant100can be substantially radially symmetrical about vertical axis y, and therefore can have substantially circular concentric cross-sections each describable by its diameter.FIG. 6Ahighlights the height HI of the implant100in a predetermined shape measured between the inversions122,124, the outer diameter D1of the outer segment142, which corresponds to the diameter of the open end114, and the outer diameter D2of the middle segment D2. AlthoughFIG. 6Aillustrates only one example predetermined shape, it should be understood that the height and diameter of example implants described herein100,200,300,400and portions thereof can be measured similarly to as illustrated inFIG. 6A.

FIG. 6Bis an illustration of height HA, sac diameter DA, and neck diameter DN measurements of an aneurysm10. The location of the plane18defining a boundary between the aneurysm10and blood vessels is also illustrated.

FIG. 7Ais an illustration of an example implant200having a tubular braid210in an alternative predetermined shape.FIG. 7Bis an illustration of the example implant200in an aneurysm10with the tubular braid210in an implanted shape. The tubular braid210can have an open end214and a pinched end212. The implant200can include a detachment feature150attached to the braid210at the pinched end212. The braid210can be formed in the predetermined shape, collapsed for delivery through a microcatheter, attached to a delivery system at the detachment feature150, and implanted in the implanted shape.

As illustrated inFIG. 7A, when in the predetermined shape, the tubular braid210can include two inversions222,224, dividing the braid210into three segments242,244,248. In the predetermined shape, the braid210can have an outer segment242extending from the open end214of the braid210to one of the inversions222, an inner segment248extending from the pinched end212of the braid210to the other of the inversions224, and a middle segment244extending between the two inversions222,224. When in the predetermined shape, the tubular braid210can be substantially radially symmetrical about a central vertical axis y (seeFIG. 6A).FIG. 7Aillustrates a profile of each segment242,244,248.

Comparing the predetermined shape of the braid210illustrated inFIG. 7Ato that of the braid110illustrated inFIG. 1A, the outer segments142,242and middle segments144,244are respectively similar to each other, and the inner segment248of the braid210illustrated inFIG. 7Ais longer than the inner segment146of the braid110illustrated inFIG. 1A. The pinched end212of the braid210inFIG. 7Ais positioned near the inversion222adjacent the outer segment242rather than near the inversion124near the inner segment146as illustrated inFIG. 1A. The elongated inner segment248illustrated inFIG. 7Acan be positioned to help the implant200resist compaction when implanted as illustrated inFIG. 7B.

The tubular braid210illustrated inFIG. 7Acan be formed into the predetermined shape similar to as described in relation toFIG. 1Awith some differences. The middle segment244need not have bends132,134positioned facilitate the movement of the braid210into a second implanted shape. The inner segment248as illustrated inFIG. 7Acan be made longer than that illustrated inFIG. 1A. The inner segment248can be shaped to have a length that is optimized to reduce the likelihood that the implant200can become compacted when implanted.

An implant200having a braid210having a predetermined shape as illustrated inFIG. 7Acan have outer dimensions in the predetermined shape including an outer diameter and height similar to as illustrated and described in relation toFIG. 2H. The inner segment248of the braid210illustrated inFIG. 7Acan have a height that is approximately equal to the height of the braid210in the predetermined shape.

The braid210can be elongated to a single layer tubular braid in a delivery shape that is sized to traverse a microcatheter. The length of the braid210in the delivery shape can be measured from the open end214to the pinched end212. A braid210having a predetermined shape as illustrated inFIG. 7Aand outer dimensions as illustrated and described in relation toFIG. 2Hcan have a length in the delivery shape that is longer compared to the length of the braid110illustrated inFIG. 2A. The length of the braid210illustrated inFIG. 7Awhen in the delivery shape can be longer than a braid110having a predetermined shape as illustrated inFIG. 1Aby about the height of the braid110,210in the predetermined shape. In other words, an implant200having a braid210with a predetermined shape as illustrated inFIG. 7Acan have an outer diameter between about 6 mm and about 6.5 mm and a height between about 5 mm and 5.5 mm when in the predetermined shape and can be elongated to a single layer tube having a circumference collapsed to fit within a microcatheter and a length measuring between about 27 mm and 30 mm. The ratio of outermost diameter in the predetermined shape to length in the delivery shape can be between about 0.24 and about 0.2.

As illustrated inFIG. 7B, when in the implanted shape, the braid210can have an outer layer242acontacting the aneurysm's wall14, a sack244anested within the outer layer242a, a proximal inversion222apositioned at the aneurysm's neck16, and a distal inversion224apositioned near a distal portion15of the aneurysm wall14. The detachment feature150and pinched end212of the braid210can be positioned near the aneurysm neck16, near the proximal inversion222a. The detachment feature150and pinched end212can be positioned to reduce the likelihood that the implant200becomes impacted.

FIG. 8Ais an illustration of an example implant300having a tubular braid310in another alternative predetermined shape.FIG. 8Bis an illustration of the example implant300when the tubular braid310in an implanted shape. The tubular braid310can have an open end314and a pinched end312, and a detachment feature150can be attached to the braid310at the pinched end312. The braid310can be formed in the predetermined shape, collapsed for delivery through a microcatheter, attached to a delivery system at the detachment feature150, and implanted in the implanted shape.

As illustrated inFIG. 8A, when in the predetermined shape, the tubular braid310can include two inversions322,324, dividing the braid310into three segments342,344,346. In the predetermined shape, the braid310can have an outer segment342extending from the open end314of the braid310to one of the inversions322, an inner segment346extending from the pinched end312of the braid310to the other of the inversions324, and a middle segment344extending between the two inversions322,324. When in the predetermined shape, the tubular braid310can be substantially radially symmetrical about a central vertical axis.FIG. 8Aillustrates a profile of each segment342,344,346.

Comparing the predetermined shape of the braid310illustrated inFIG. 8Ato that of the braid110illustrated inFIG. 1A, the outer segments142,342and inner segments146,346are respectively similar to each other, and the middle segment344of the braid310illustrated inFIG. 8Ahas an undulating pattern rather than the “S” shape of the middle segment144of the braid110illustrated inFIG. 1A. The undulating middle segment344can be radially symmetrical to form a honeycomb shape. When implanted, the middle segment344in the undulating pattern can provide a force pattern pressing outwardly to anchor the implant300within an aneurysm that is different from a force pattern that could be provided by the middle segment144having the “S” shape illustrated inFIG. 1A. The pinched end312of the braid310inFIG. 8Acan be positioned near the inversion324adjacent the inner segment346as illustrated. Alternatively, the inner segment346can be shaped to extend to the inversion322adjacent the outer segment342to provide a compaction resistant column.

The tubular braid310illustrated inFIG. 8Acan be formed into the predetermined shape similar to as described in relation toFIG. 1Awith some differences. The middle segment344can be formed to have an undulating pattern rather than an “S” shaped pattern. The middle segment344need not have bends positioned facilitate the movement of the braid310into a second implanted shape.

As illustrated inFIG. 8B, when in the implanted shape, the braid310can have an outer layer342ashaped to contact an aneurysm wall, compressed extensions of an undulating middle layer344anested within the outer layer342a, a proximal inversion322apositioned to be placed an aneurysm neck, and a distal inversion324apositioned to be placed near a distal portion of the aneurysm wall. The detachment feature150and pinched end312of the braid310can be positioned within the aneurysm sac, either near the distal inversion324aas illustrated, near the proximal inversion322a, or at a position in between. The detachment feature150and pinched end312can be positioned to reduce the likelihood that the implant300becomes impacted.

FIG. 9Ais an illustration of an example implant400having a tubular braid410in another alternative predetermined shape.FIG. 9Bis an illustration of the example implant400illustrating the tubular braid410in an implanted shape. The tubular braid410can have an open end414and a pinched end412. A detachment feature150can be attached to the braid410at the pinched end412. The implant400can be formed in the predetermined shape, collapsed for delivery through a microcatheter, attached to a delivery system at the detachment feature150, and implanted in the implanted shape.

As illustrated inFIG. 9A, when in the predetermined shape, the tubular braid410can include two inversions422,424, dividing the braid410into three segments442,444,446. In the predetermined shape, the braid410can have an outer segment442extending from the open end414of the braid410to one of the inversions422, an inner segment446extending from the pinched end412of the braid410to the other of the inversions424, and a middle segment444extending between the two inversions422,424. When in the predetermined shape, the tubular braid410can be substantially radially symmetrical about a central vertical axis y (seeFIG. 6A).FIG. 9Aillustrates a profile of each segment442,444,446.

Comparing the predetermined shape of the braid410illustrated inFIG. 9Ato that of the braid110illustrated inFIG. 1A, the outer segments142,442can be similar to each other, the middle segment444of the braid410illustrated inFIG. 9Acan have a less pronounced “S” shape compared to the “S” shaped middle segment144illustrated inFIG. 1A, and the inner segment446can be conical or “V” shaped in profile with the pinch end412positioned near the inversion422adjacent the outer layer442rather than near the inversion424adjacent the inner layer146as illustrated inFIG. 1A. When implanted, the inner segment446can reshape to form a compaction resistant column.

The tubular braid410illustrated inFIG. 9Acan be formed into the predetermined shape similar to as described in relation toFIG. 1Awith some differences. The middle segment444illustrated inFIG. 9Acan be formed to have a less pronounced “S” shape pattern compared to the “S” shaped pattern144illustrated inFIG. 1A. The middle segment444need not have bends positioned facilitate the movement of the braid410into a second implanted shape. The inner segment446can have a longer length as illustrated inFIG. 9Acompared to the inner segment146illustrated inFIG. 1A. The inversion424adjacent the inner segment446can have a more acute curvature as illustrated inFIG. 9Acompared to the corresponding inversion124illustrated inFIG. 1A.

As illustrated inFIG. 9B, when in the implanted shape, the braid410can have an outer layer442ashaped to contact an aneurysm wall, a tulip or heart shaped sack444anested within the outer layer442a, a proximal inversion422apositioned to be placed at an aneurysm neck, a distal inversion424apositioned to be placed near a distal portion of the aneurysm wall, and a compaction resistant column446aextending within the sack444a. The detachment feature150and pinched end412of the braid410can be positioned within the sack444anear the proximal inversion422a. The detachment feature150and pinched end412can be positioned to reduce the likelihood that the implant400becomes impacted.

FIG. 10is an illustration of an example implant400having a tubular braid410in a predetermined shape similar to as illustrated inFIG. 9A.

FIGS. 11A through 11Eare illustrations of the example implant400illustrated inFIG. 10showing the tubular braid410expanding to the implanted shape within a mock aneurysm10similar to as illustrated inFIG. 9B. As illustrated inFIG. 11A, the open end414can exit the microcatheter first and expand within the aneurysm10. As illustrated inFIG. 11B, a distal portion of the braid410corresponding to the outer layer442in the predetermined shape can expand to appose the aneurysm wall14forming the outer layer442ain the implanted shape. As illustrated inFIG. 11C, the braid410can begin to invert as the braid410is further pushed distally from the microcatheter600. As illustrated inFIG. 11D, the proximal inversion422acan be placed at the aneurysm neck16as the tulip shaped sack444aexpands within the outer layer442a. As illustrated inFIG. 11E, the braid410can be shaped in the implanted shape within the aneurysm10similar to as illustrated inFIG. 9B.

Any of the implants100,200,300,400illustrated and described herein can include one or more additional braid layers that move substantially parallel to the tubular braid110,210,310,410. The multiple layers can be stacked coaxially with each other and heat treated as a single unit into a predetermined shape. In some applications, multiple layers may be able to provide additional coverage at the aneurysm neck and additional support and conformability within the aneurysm. Each one layer of the braid can be selected with different properties with different wire counts and thickness, braid angle and diameter and wire material to potentially increase metal coverage, reduce profile (microcatheter size), facilitate deployment and reduce neck inlet channel size while providing visibility under angiogram.

FIG. 12Ais a cross sectional illustration of an implant500including two braid layers510,560in a predetermined shape similar to that illustrated inFIG. 1A. The braid layers510,560are constricted at a pinched end512at which a detachment feature550can be affixed to the braid layers510,560. As illustrated, in the predetermined shape, each of the braid layers510,560can have a respective open end514,564, first segment542,582, first inversion522,572, second segment544,584, first bend532,592, second bend534,594, second inversion524,574, and third segment546,586similar to as described in relation to the implant100illustrated inFIG. 1A. For each of the two braid layers510,560, the third segment extends from the pinched end512to the second inversion524,574, the second segment544,584, extends from the second inversion524,574to the first inversion and at least partially surrounds the third segment546,586, and the first segment extends542,582from the first inversion522,572and at least partially surrounds the second segment544,584. As illustrated, for each of the two layers, the first segment only partially surrounds the second segment. About the first inversion of each of the two layers, layer B (560) is nested within layer A (510). About the second inversion of each of the two layers, layer A is nested within layer B.

FIG. 12Billustrates the braid layers510,560positioned within a microcatheter600. The braid layers510,560can be positioned as coaxial tubes, as illustrated, with an inner layer560(layer B) and outer layer510(layer A). Benchtop testing has demonstrated that two layers of braid can come down to a smaller braid outer circumference (C) compared to a single layer braid with the same total wire count. Implants100,200,300,400including a single layer tubular braid110,210,310,410preferably have a wire count of 72 wires or 96 wires. With the same total wire count, an implant500having two layers510,560can reduce the braid profile size when collapsing into the delivery system. It can reduce the track force and also the microcatheter size, which can facilitate navigability to more challenging and distal vasculature. With the same delivery tube size, the two layers510,560of braid can increase the total wire count that can fit in that size. The added wire count can decrease the porosity at the neck of the aneurysm to promote flow diversion and thrombosis at the neck to promote healing and treat ruptured aneurysms more quickly. The added wires can also facilitate the deployment of an implant in larger aneurysms in different anatomic locations.

FIG. 12Cillustrates the implant500implanted in a larger aneurysm10ain a first implanted shape similar to the implanted shape illustrated inFIG. 1B. The larger aneurysm10adefines a first substantially spherical cavity having an entrance that is the neck opening16a. As illustrated, in the first implanted shape, each of the two layers have an outer layer corresponding to the first segment of the predetermined shape and a proximal inversion corresponding to the first inversion of the predetermined shape. As illustrated, the outer layer542aof layer A510is positioned to contact a cavity wall14aof the larger aneurysm10, the outer layer582aof layer B560apposes the outer layer542aof layer A510, and the proximal inversion522a,572aof each of the two layers510,560is positioned approximate the entrance16ato the larger aneurysm10a. As illustrated, each of the two layers510,560of tubular braid comprises a sack544a,584acorresponding to the second segment544,584of the predetermined shape. The sack584aof layer B560is positioned to appose a portion of the cavity wall of the larger aneurysm10a. The sack544aof layer A510is contained within the sack584aof layer B560.

The two layers510,560can press together to potentially perform like a stronger single layer braid which, in some applications can facilitate implant deployment in an angled aneurysm. When deployed in aneurysm, the outer segments of each of the two layers expand outwardly against the aneurysm wall to stabilize the braid against the aneurysm wall. Comparing an implant having a singular braid layer to an implant having two or more braid layers, the two implants having a similarly sized and shaped predetermined shape, the singular braid layer may require repositioning of the distal end of the catheter to facilitate inversion near the aneurysm neck while the implant having two or more braid layers may be inverted near the aneurysm neck by distal movement of the pinched end without requiring repositioning of the distal end of the catheter. The added wire counts can also increase the conformability and support at the aneurysm dome.

The two layers can also potentially increase chronic outward force to support the inner braid against the outer braid and resist compaction. As illustrated inFIG. 5A, a single layer braid110can provide a radial force F against the aneurysm wall14a. Similarly, two layers510,560of braid as illustrated inFIG. 12Ccan provide a radial force F against the aneurysm wall14athat is greater than the single layer braid110, all else being equal. In other words, given an implant100having a single layer braid110formed in a predetermined shape, having a total wire count, each wire having a wire circumference, and used to treat an aneurysm10aand also given an implant500having two layers510,560of braid, a total wire count equal to that of the single layer braid110, an average wire circumference about equal to the wires of the single layer braid110, and used to treat the same aneurysm or aneurysm of substantially identical size10a, the two layers510,560can provide a greater radial force F against the aneurysm wall14acompared to the single layer110.

FIG. 12Dillustrates the implant500implanted in a smaller aneurysm10bin a second implanted shape similar to the implanted shape illustrated inFIG. 1C. The smaller aneurysm10bdefines a second substantially spherical cavity having an entrance that is the neck opening16b. As illustrated, in the second implanted shape, each of the two layers510,560has an outer layer542b,582bcorresponding to the first segment542,582of the predetermined shape and a proximal inversion522b,572bcorresponding to the first inversion522,572of the predetermined shape. The outer layer542bof layer A510contacts the cavity wall14bof the smaller aneurysm10b. The outer layer582bof layer B560apposes the outer layer542bof layer A510. The proximal inversion522b,572bof each of the two layers is placed approximate the entrance16bto the second substantially spherical cavity10b. Each of the two layers of tubular braid have a middle layer544b,584band inner layer546b,586bcorresponding to the second segment544,584of the predetermined shape and a fold524b,564bseparating the middle and inner layer. The inner layer586bof layer B560apposes the inner layer546bof layer A510which apposes the middle layer544bof layer A510which apposes the middle layer584bof layer B560which apposes the outer layer582bof layer B560.

In the predetermined shape illustrated inFIG. 12A, each of the two layers510,560of tubular braid comprises one or more bends532,534,592,594positioned in the respective second segment544,584. In the second implanted shape illustrated inFIG. 12D, for each of the two layers510,560, the fold524b,574bseparating the middle layer544b,584band the inner layer546b,586bcorresponds to one of the bends in the second segment of the predetermined shape.

In the first implanted shape illustrated inFIG. 12C, the pinched end512is suspended within the sacks544a,584aof layer A510and layer B560. In the second implanted shape illustrated inFIG. 12D, the pinched end512is encircled by the proximal inversions522a,572aof layer A510and layer B560.

In the first implanted shape illustrated inFIG. 12C, the two layers510,560form an open end514,564that encircles the sack544a,584a. In the second implanted shape illustrated inFIG. 12D, the open end514,564encircles the fold524b,574bfor each of the two layers510,560.

The implant500can be delivered and implanted following steps similar to those illustrated inFIGS. 3A through 3G. The implant500can be positioned within an aneurysm/spherical cavity solely via manipulation of the pinched end and positioning of the distal end of the catheter. A distal end of a catheter can be positioned near an aneurysm neck/cavity entrance. The pinched end512of the implant500can be pushed distally to push the implant500through at least a portion of the catheter600. The outer layer542a,542bof layer A510can be apposed to the aneurysm wall14. The outer layer582a,582bof layer B560can be apposed to the outer layer542a,542bof layer A510. For at least the first implanted shape, a sack584acan be formed from layer B560that is at least partially surrounded by the outer layers542a,582aof layer A and layer B and a sack544acan be formed from layer A510that is at least partially surrounded by the outer layers of layer A and layer B and contained within the sack of layer B. The pinched end can be disengaged while two layers510,560each retain their respective sacks544a,584ato leave the implant500implanted in the first implanted shape. For at least the second implanted shape, the second segment544,584of each of the two layers510,560in the second implanted shape can be folded to form the inner layer546b,586band middle layer544b,584bseparated by the fold524b,574bsuch that that the inner layer586bof layer B560apposes the inner layer546bof layer A510which apposes the middle layer544bof layer A510which apposes the middle584blayer of layer B560which apposes the outer layer582bof layer B560.

By virtue of having two implanted shapes, similar to the implant100illustrated inFIGS. 1A through 1C, the implant500illustrated inFIGS. 12A through 12Dcan be suitable (via appropriate jurisdictional requirements for medical devices) for treating a first aneurysm having a first diameter measuring about 4 mm and a first height measuring about 6 mm, a second aneurysm comprising a second diameter measuring about 5 mm and a second height measuring about 8 mm, and a third aneurysm comprising a third diameter measuring about 6 mm and a third height measuring about 6 mm. Also, by virtue of having two implanted shapes, similar to the implant100illustrated inFIGS. 1A through 1C, the implant500illustrated inFIGS. 12A through 12Dcan be suitable for treating aneurysms within a continuum of aneurysm sizes, the continuum bounded by and including diameters between about 4 mm and about 5 mm and heights between about 6 mm and about 8 mm.

FIG. 13illustrates a cross section of another implant700having two braid layers710,760in a predetermined shape. The implant700is formed to the predetermined shape similar to the implants100,500illustrated inFIGS. 1A and 12A. The implant700illustrated inFIG. 13differs primarily from the implant500illustrated inFIG. 12Ain the area of the neck channel526,716.

Including two or more braid layers can potentially decrease the inner neck channel size for devices made of Nitinol-platinum wire woven braid. In other words, for a substantially identical process of achieving a predetermined shape, the neck channel opening526,726of an implant500,700having two layers510,710,560,760can be smaller than the neck channel opening126of an implant100having a single braid layer110. Similarly, when implanted, the neck channel opening526aillustrated inFIG. 12Ccan be smaller than the neck channel opening126aillustrated inFIG. 1Band further smaller for neck channel726inFIG. 13. A neck channel having a large opening can allow constant blood flow to reach the aneurysm neck and slow down healing. Platinum wires added to a braid generally make the braided portion of the respective implant visible under angiogram. However, because the platinum wire does not retain its shape as well as the nitinol wire after heat treatment, when deployed, a nitinol-platinum braid device is expected to have a bigger neck channel opening compared to an all nitinol braid (where the nitinol-platinum braid and the all nitinol braid have substantially identical predetermined shapes).

Depending on the specific needs and braid properties, in an implant including two or more braid layers, an all nitinol braid can be used in combination with a nitinol-platinum braid such that the nitinol-platinum braid facilitates visualization of the braided portion of the braid and the all nitinol braid facilitates movement of the braid layers to the predetermined shape. The all nitinol braid can either be used as the inside or outside braid to reduce the inner channel size when fabricated with nitinol-platinum braid.FIG. 12Aillustrates an implant500having an all nitinol braid is positioned outside during delivery, layer A510, and a nitinol-platinum braid positioned on the inside during delivery, layer B560. When deployed, the nitinol braid510can create a small neck inner channel526aand can cover a larger channel of a nitinol-platinum braid560.FIG. 13illustrates an implant700having an all nitinol braid positioned as layer B760and a nitinol-platinum braid positioned as layer A710. When deployed, the nitinol braid760can cinch down on the nitinol-platinum braid710and create a double layered neck channel726that is smaller than the opening of the neck channel126with a nitinol-platinum braid alone110as illustrated inFIG. 1A.

Referring toFIG. 13, the braid layers710,760are constricted at a pinched end712at which a detachment feature750can be affixed to the braid layers710,760. As illustrated, in the predetermined shape, each of the braid layers710,760can have a respective open end714,764, first segment742,782, first inversion722,772, second segment744,784, first bend732,792, second bend734,794, second inversion724,774, and third segment746,786similar to as described in relation to the implant100illustrated inFIGS. 1A and 1nrelation to the implant500illustrated inFIG. 12A. For each of the two braid layers710,760, the third segment746,786extends from the pinched end712to the second inversion724,774, the second segment744,784, extends from the second inversion724,774to the first inversion and at least partially surrounds the third segment746,786, and the first segment742,782extends from the first inversion722,772and at least partially surrounds the second segment744,784. As illustrated, for each of the two layers710,760, the first segment742,782only partially surrounds the respective second segment744,784. About the first inversion722,772of each of the two layers, layer B760is nested within layer A710. About the second inversion724,774of each of the two layers, layer A710is nested within layer B760.

The implant700can be delivered through a catheter600similar to as illustrated inFIG. 12B. The implant can be positioned through steps similar to as illustrated inFIGS. 3A through 3Gand described in relation toFIGS. 12A through 12D. The implant700can be implanted in two distinct implanted shapes similar to as illustrated inFIGS. 12C and 12D.

FIG. 14illustrates a cross section of another implant800having two braid layers810,860in a predetermined shape. The implant800has a predetermined shape similar to that illustrated inFIG. 7A, a difference being the implant800illustrated inFIG. 14has two tubular braid layers while the implant illustrated inFIG. 7Ahas one tubular braid. The implant800illustrated inFIG. 14also has a predetermined shape similar to that illustrated inFIG. 12A, a difference being the implant800illustrated inFIG. 14includes a dual layer compaction resistant post formed from inner segments846,886of the braid810.

The braid layers810,860are constricted at a pinched end812at which a detachment feature850can be affixed to the braid layers810,860. As illustrated, in the predetermined shape, each of the braid layers810,860can have a respective open end814,864, first segment842,882, first inversion822,872, second segment844,884, first bend832,892, second bend834,894, second inversion824,874, and third segment846,886similar to as described in relation to the implant100illustrated inFIGS. 1A and 1nrelation to the implant500illustrated inFIG. 12A. For each of the two braid layers810,860, the third segment846,886extends from the pinched end812to the second inversion824,874, the second segment844,884, extends from the second inversion824,874to the first inversion and at least partially surrounds the third segment846,886, and the first segment842,882extends from the first inversion822,872and at least partially surrounds the second segment844,884. As illustrated, for each of the two layers810,860, the first segment842,882only partially surrounds the respective second segment844,884. About the first inversion822,872of each of the two layers, layer B860is nested within layer A810. About the second inversion824,874of each of the two layers, layer A810is nested within layer B860.

The two layers810,860of tubular braid can be stabilized in an implanted shape based on the predetermined shape illustrated inFIG. 14when the braid layers810,860are constrained by a substantially spherical cavity such as the interior of an aneurysm. In the implanted shape, layer A810has an outer layer corresponding to the first segment842that apposes the cavity wall of the substantially spherical cavity/aneurysm, layer B760has and outer layer corresponding to the first segment882that apposes to the outer layer of layer A810, layer B860has an inner sack corresponding to the middle segment884that apposes to the outer layer of layer B860, layer A810has an inner sack corresponding to the middle segment844positioned within the inner sack of layer B860, for each of the two layers810,860, a proximal inversion corresponding to the first inversion822,872is positioned approximate an entrance to the substantially spherical cavity/aneurysm neck, for each of the two layers810,860, a distal inversion corresponding to the second inversion824,874is positioned approximate a distal portion of the cavity wall, and each of the two layers810,860has a post corresponding to the third segment846,886, the post extending centrally within the inner sack and along a majority of a length between the distal inversion and the proximal inversion such that the post of layer B is positioned within the post of layer A.

The implant800can be delivered and implanted similar to as described in relation to the first implanted shape of the implant500illustrated inFIGS. 12A through 12Cwith a difference being that the pinched end812of the implant800illustrated inFIG. 15can be positioned near the aneurysm neck, a tubular segment of layer A corresponding to the third segment846can be extended within the sack of layer A810and the sack of layer B860to terminate at the pinched end812, and a tubular segment of layer B860corresponding to the third segment886can be extended within the tubular segment of layer A810to terminate at the pinched end812.

Although not illustrated, the implants300,400illustrated inFIGS. 8A-B,9A-B,10, and11A-E can alternatively include two or more braid layers according to the principles illustrated and described in relation toFIGS. 12A-D,13, and14. Further, each implant100,200,300,400,500,700,800can include a total of two, three, four, or five braid layers.

FIGS. 15A to 15Care illustrations of an example tubular implant900that can have a predetermined shape. The implant900can treat a range of aneurysm sizes. The implant900can include a tubular braid910having an open end914and a pinched end912. The predetermined shape is the expanded shape of the tubular braid910when the braid910is not confined by a delivery catheter. When implanted, the braid910is in an implanted shape, which is based at least in part on the predetermined shape and the anatomy of the aneurysm10. The tubular braid910can be composed of one or more wires.

The implant900can include a connection and detachment feature150attached to the braid910at the pinched end912. The pinched end912can include a marker band and/or soldered point with visibility, and/or the connection feature150can include radiopaque material. The tubular braid910can be formed in a predetermined shape (FIGS. 15A to 15C), collapsed for delivery through a microcatheter, attached to a delivery system at the connection feature150, and implanted in an implanted shape such as the ones shown inFIGS. 16A and 16B.

Referring toFIGS. 15A through 15C, when in a predetermined shape, the tubular braid910can include an inversion922, a pinched end912, and an open end914. The tubular braid can include two segments,942and944. The first segment942can extend from the open end914of the tubular braid910to a proximal inversion922. The second segment944can be at least partially surrounded by the open end914and can extend from the proximal inversion922to the pinched end912. The second segment, as shown inFIGS. 15A to 15C, can also include at least one corrugated fold950. The first segment, as shown inFIGS. 15B and 15C, can also include at least one corrugated fold960. The corrugated folds950,960can be configured to assist in anchoring the device when in an implanted shape (e.g.FIGS. 16A and 16B) within an aneurysm10. The corrugated folds can act in a similar manner to stent struts to help the tubular braid910hold its predetermined or implanted shape.

When in a predetermined shape, the tubular braid910can be substantially radially symmetrical about a central vertical axis. The tubular braid can be formed into a predetermined shape by inverting the braid inwardly to separate the second segment944from the first segment942. The tubular braid910can include memory shape material that can be heat set to the predetermined shape. This heat-set material can be utilized to form one or more corrugations950,960in the first and/or second segments942,944.

As illustrated inFIG. 16C, the one or more wires of the tubular braid910making up the corrugated folds950,960can be compressed or flattened along a vertical axis, resulting in a smaller wire diameter along the vertical axis of the corrugated fold950,960relative to the non-compressed portions of the tubular braid910. The compressed portions of the wires making up the corrugated folds950,960can also have a different cross-sectional shape relative to non-compressed portions of wire in the tubular braid910. For instance, the non-compressed portions of wire can be circular, while the compressed portions can be ellipsoid in shape. Flattening the one or more wires making up the corrugated folds950,960can make these portions of the tubular braid910more rigid, thereby assisting in maintaining the shape of the tubular braid910and anchoring it within an aneurysm. By compressing the wires, the wires are no longer able to bend or flex equally in all directions. Preferably, flattening the one or more wires making up the corrugated folds950,960can make the wires bendable in two opposite directions. Therefore, portions of the braid910constructed with flattened wires, such as corrugated folds950,960can be more resistant to bending relative to non-flattened wires in the remainder of the braid.

The tubular braid910can be deformed for delivery through a catheter and can self-expand to an implanted shape (e.g.,FIGS. 16A and 16B) that is based on a predetermined shape and confined by the anatomy of the aneurysm in which it is implanted. When the tubular braid910is in the predetermined shape, at least one corrugated fold950in the second segment944can appose the first segment942or a corrugated fold960in the first segment942, thereby exerting an outwardly radial force on the first segment942.

The tubular braid910in the implanted shape can be radially or vertically compressed or extended compared to the predetermined shape. Compressing the tubular braid910can cause the folds in the inner layer950ato provide a force against the first segment942aand/or a corrugated fold in the first segment960a. This compression can also cause the corrugated folds960ain the first segment942ato apply a radial force against the aneurysm wall14.

FIG. 16Aillustrates the predetermined shape inFIG. 15Aas implanted into an aneurysm. In the implanted shape inFIG. 16A, the braid910can have an outer layer942acorresponding to the first segment942of the predetermined shape and positioned to contact an aneurysm wall14of the aneurysm10. A proximal inversion922acan correspond to the proximal inversion922of the predetermined shape and positioned to be placed approximate a neck16of an aneurysm10. An inner layer944acan correspond to the second segment944of the predetermined shape. The tubular braid910can have at least one corrugated fold950ain the inner layer corresponding to the at least one corrugated fold in the second segment of the predetermined shape.

When the tubular braid910is in the implanted shape within an aneurysm10, at least one corrugated fold in the inner layer950acan appose at least a portion of the outer layer942a, thereby exerting an outwardly radial force on the outer layer942ato anchor the implant900within the aneurysm10. The wire of the tubular braid910comprising the corrugated folds950ain the inner layer946acan be flattened as described inFIGS. 15A to 15Cand shown inFIG. 16Cto increase the rigidly of the corrugations and assist with anchoring the tubular braid910within the aneurysm10.

InFIG. 16B, the predetermined shape ofFIG. 15Bis in the implanted shape. In this implanted shape, the tubular braid910can also have at least one corrugated fold in the outer layer960acorresponding to the at least one corrugated fold in the first segment of the predetermined shape. The corrugated folds of the inner layer950acan be formed in a position such that they appose corrugated folds in the outer layer960awhen in the implanted shape. The corrugated folds of the outer layer960aprovide an outwardly radial force in a plane defining a boundary between the aneurysm10and a blood vessel22a,22b, the force sufficient to appose the outer layer942ato walls14of the aneurysm10and anchor the implant900within the aneurysm. Further, as illustrated inFIG. 16B, the wire of the tubular braid910comprising the corrugated folds960ain the outer layer942acan also be flattened as shown inFIG. 16Cto increase the rigidly of the corrugations and assist with anchoring the tubular braid910within the aneurysm10.

A method for forming an implant900to treat an aneurysm can include positioning a distal end of a catheter approximate a neck16of an aneurysm10, pushing a pinched end912of a tubular braid910having one or more wires and an open end914distally through at least a portion of the catheter, positioning the open end914within a sac12of the aneurysm10; and deploying the tubular braid910to an implanted shape within the aneurysm based upon a predetermined shape. The implant900can be deployed to an implanted shape within the aneurysm based upon a predetermined shape by inverting the tubular braid910to form a proximal inversion922aby moving the open end914over at least a portion of the braid910, shaping an outer layer942aof the tubular braid910extending between the open end914and the proximal inversion922a, and shaping an inner layer of the tubular braid944aextending between the proximal inversion922aand the pinched end912, wherein at least one corrugated fold950ais located within the inner layer944a.

The method can further include positioning the implant within the aneurysm sac solely via manipulation of the pinched end and via positioning of the distal end of the catheter. The outer layer can also include at least one corrugated fold960awithin the outer layer942a. When implanted, at least one corrugated fold950awithin the inner layer944acan provide an outwardly radial force against the outer layer942a, against a corrugated fold in the outer layer960ain a plane defining a boundary between the aneurysm10and a blood vessel22, or both. The force can be sufficient to appose the outer layer942ato walls14of the aneurysm10. In a similar manner, the corrugated folds960aof the outer layer942acan provide an outwardly radial force in a plane defining a boundary between the aneurysm10and a blood vessel22, the force sufficient to appose the outer layer942ato walls14of the aneurysm10.

The wire of the tubular braid910comprising the at least one corrugated folds can be compressed along a vertical axis such that the diameter of the corrugated fold along the axis is lesser than the diameter of the uncompressed portions of the tubular braid910. This compression can increase the rigidity of the at least one corrugated fold relative to the rest of the braid.

Some examples presented herein generally include a braided implant that can secure within an aneurysm sac and occlude a majority of the aneurysm's neck. The implant can include a tubular braid that can be set into a predetermined shape, compressed for delivery through a microcatheter, and implanted in at least one implanted position that is based on the predetermined shape and the geometry of the aneurysm in which the braid is implanted. The implant can include a single layer of braid (e.g. a braid that can be extended to form a single layer tube) heat treated into multiple layers with retractable dual layer at the proximal end of the tubular braid. When compressed, the implant can be sufficiently short to mitigate friction forces produced when the implant is delivered unsheathed through the microcatheter.

A first portion of the tubular braid can be positioned in an aneurysm, after which the retractable dual layer can be deployed from the microcatheter and pushed onto the first portion of the tubular braid. This configuration provides three layers of braid at the neck of the aneurysm. The dual layer can potentially cover any gap between the first portion of implanted tubular braid and the aneurysm neck, and can potentially increase metal coverage, decrease porosity of the implant, and increase stasis and blood flow diversion at the neck of the aneurysm to promote the sealing and healing of the aneurysm compared a similarly shaped braided implant lacking the dual layer. The entire implant can be retractable until a desired position is achieved.

FIGS. 17A and 17Bare illustrations of an example braided implant100that can have a predetermined shape as shown inFIG. 17Aand a distinct implanted shape as illustrated inFIG. 17B. The implant1000can treat a range of aneurysm sizes. The implant1000can include a tubular braid1010having an open end1014and a pinched end1012. The implant1000can include a connection and detachment feature150(referred to equivalently as “connection feature” and “detachment feature” herein) attached to the braid1010at the pinched end1012. The pinched end1012can include a marker band and/or soldered point with visibility, and/or the connection feature150can include radiopaque material. The tubular braid1010can be formed in the predetermined shape (FIG. 17A), collapsed for delivery through a microcatheter, attached to a delivery system at connection feature150, and implanted in an implanted shape such as the one shown inFIG. 17B.

Referring toFIG. 17A, when in the predetermined shape, the tubular braid1010can include two inversions1022,1024, a pinched end1012, and an open end1014. The tubular braid1010can include four segments,1042,1044,1046, and1052. The first segment1042can extend from the open end1014of the tubular braid1010to a proximal inversion1022. The second segment1044can be encircled by the open end1014and extend from the proximal inversion1022to a distal inversion1024. The third segment1046can be surrounded by the second segment1044and extend from the distal inversion1024to the proximal inversion1022. The first segment1042, second segment1044, and third segment1046can form the first portion of the tubular braid1010. The fourth segment1052can extend from the third segment1046radially outward from a central axis to cross the proximal inversion1022, fold, and converge at the pinched end1012. The fourth segment1052can be partially encircled by the proximal inversion1022.

When in the predetermined shape, the tubular braid1010can be substantially radially symmetrical about a central vertical axis. The detachment feature150is illustrated inFIG. 17Aas a flat key that can be used with a mechanical delivery implant system (not pictured). The tubular braid1010can be formed into the predetermined shape by first inverting the braid outwardly to separate the third segment1046from the second segment1044with a distal inversion1024. Then, the second segment1044can be shaped over a form to produce the substantially “S” shaped profile illustrated inFIG. 17A. Next, the braid1010can be inverted outwardly again to separate the second segment1044from the first segment1042with a proximal inversion1022. Finally, the fourth segment1052can be shaped by expanding the fourth segment1052radially. The fourth segment1052can be pressed distally into the first portion of the tubular braid1010. It can also be advantageous to minimize a neck opening1026defined by the lower extension of the “S” shape of second segment1044to maximize occlusion of an aneurysm neck when the implant1000is implanted.

The tubular braid1010can include memory shape material that can be heat set to a predetermined shape, can be deformed for delivery through a catheter, and can self-expand to an implanted shape that is based on the predetermined shape and confined by the anatomy of the aneurysm in which it is implanted. When the tubular braid1010is in the predetermined shape as depicted inFIG. 17A, the fourth segment1052can comprise a diameter D1greater than or approximately equal to a maximum diameter D2of the first segment1042. Alternatively, when the tubular braid1010is in the predetermined shape as depicted inFIG. 17A, the fourth segment1052can comprise a diameter D1lesser than a maximum diameter D2of the first segment1042. When the tubular braid1010is in the predetermined shape (FIG. 17A), the second segment1044can form a sack, and at least a portion of the third segment1046can positioned within the sack and at least a portion of the fourth segment1052can be positioned external to the sack. As illustrated (FIG. 17B), when implanted, the fourth segment1052can be positioned external to the aneurysm sac, extending across the aneurysm neck16. Preferably, the fourth segment1052can appose vasculature walls surrounding the aneurysm neck16when implanted. Alternatively, the shaped fourth segment1052can also be placed within the aneurysm sac. The detachment feature150can be implanted centrally in the aneurysm neck16. The detachment feature150can be positioned external to the sac12.

The tubular braid1010in the implanted shape (FIG. 17B) can be radially or vertically compressed or extended compared to the predetermined shape. As illustrated inFIG. 17B, when in the implanted shape, the braid1010can have an outer layer1042acorresponding to the first segment1042of the predetermined shape and positioned to contact an aneurysm wall14of the aneurysm10, a proximal inversion1022acorresponding to the proximal inversion1022of the predetermined shape and positioned to be placed approximate a neck16of the aneurysm10, and a sack1044acorresponding to the second segment1044of the predetermined shape and positioned to appose a portion of the aneurysm wall14of the aneurysm10and apposing the outer layer1042a. A distal inversion1024acan correspond to the distal inversion1024of the predetermined shape, a third segment1046acan correspond to the third segment1046in the predetermined shape. The braid1010can also have a fourth segment1052acorresponding to the fourth segment1052of the predetermined shape and extending from the third segment1046aradially outward from a central axis to cross the proximal inversion1022a, fold, and converge at the pinched end1012. As described inFIG. 17A, the fourth segment1052acan be pressed distally into the first portion of the tubular braid1010.

By pressing the fourth segment1052adistally into the first portion of the tubular braid1010, the first portion1042a, of the tubular braid1010can be moved towards the distal portion of an aneurysm wall15to occlude a portion of the neck16of the aneurysm10. Pushing the fourth segment1052ainto the first portion of the braid1010can help conform the implant1000to the shape of the aneurysm10and resist compaction. The fourth segment1052awhen expanded radially and pressed into the first portion of the braid1010also can provide additional coverage at the neck16of the aneurysm10to increase thrombosis and seal the aneurysm10. When the fourth segment1052ais pressed into the first portion of the braid1010, three layers of braid are present at the neck of the aneurysm. The fourth segment1052acan cover spatial gaps between the first portion of implanted tubular braid1010and the aneurysm neck16, and can potentially increase metal coverage, decrease porosity of the implant1000, and increase stasis and blood flow diversion at the neck16of the aneurysm10to promote the sealing and thrombosis of the aneurysm10. The fourth segment1052acan be shaped to occlude the majority of an aneurysm neck16when the device1000is implanted. The fourth segment1052acan be shaped to completely occlude an aneurysm neck16when the device1000is implanted.

When the tubular braid1010is in the implanted shape (FIG. 17B), the fourth segment1052acan comprise a diameter D1greater than or approximately equal to a maximum diameter D2of the first segment1042a. Alternatively, when the tubular braid1010is in the implanted shape (FIG. 17B), the fourth segment1052acan comprise a diameter D1lesser than a maximum diameter D2of the first segment1042a. When the tubular braid1010is in the implanted shape (FIG. 17B), the second segment1044acan form a sack, and at least a portion of the third segment1046acan be positioned within the sack and at least a portion of the fourth segment1052acan be positioned external to the sack. The shaped fourth segment1052acan also be placed within the aneurysm sac12with only the detachment point150external to the sac12.

FIGS. 18A through 18Iare illustrations of an example implant1000having a braid1010expanding to an implanted shape that is based on a predetermined shape and the anatomy of the aneurysm and nearby blood vessel as the braid1010exits a microcatheter600. The implant1000has a predetermined shape similar to the shape illustrated inFIG. 17A. As illustrated inFIG. 18A, the braid1010can be shaped to a delivery shape that is extended to a single layer of tubular braid having a compressed circumference/diameter sized to be delivered through the microcatheter600and a length L. As will be appreciated and understood by a person of ordinary skill in the art, the length L of a specific braid1010can be tailored based on the size and shape of the aneurysm being treated. The length L can be approximately 1 inch in length.

During delivery through the microcatheter600, the detachment feature150can be attached to a delivery system at a proximal end of the implant1000, the pinched end1012can be positioned near the proximal end of the implant1000, and the open end1014can define the distal end of the implant1000. Collapsing the braid1010to a single layer tube can result in a braid1010that has a sufficiently small diameter and a sufficiently short length L to mitigate effects of friction force on the braid1010when it is delivered through the microcatheter, allowing the braid1010to be delivered unsheathed in some applications

As illustrated inFIG. 18B, the implant1000can be delivered to an aneurysm10through the microcatheter600. The open end1014can be positioned to exit the microcatheter600before any other portion of the braid1010exits the microcatheter. The open end1014can expand within the aneurysm sac12as it exits the microcatheter600. The illustrated aneurysm10is positioned at a bifurcation including a stem blood vessel20and two branch vessels22a,22band the microcatheter600is illustrated being delivered through the stem blood vessel20. It is contemplated that the implant could be delivered to an aneurysm on a sidewall of a blood vessel through a curved microcatheter, and such a procedure is intended to be embraced by the scope of the present disclosure. As illustrated inFIG. 18C, the distal portion of the braid1010can continue to expand radially within the aneurysm sac12as it exits the microcatheter600. As the braid1010is further pushed distally from the microcatheter600, the braid1010can appose the aneurysm wall14and conform approximate the aneurysm neck16. The aneurysm10being treated can have a diameter that is less than the outer diameter of the tubular braid1010in the predetermined shape so that the braid1010tends to expand outwardly, providing a force against the aneurysm wall14and sealing approximate the perimeter of the aneurysm neck16.

As illustrated inFIG. 18D, the braid1010can form the proximal inversion1022adefining the first segment1042aas the braid1010is further pushed out of the microcatheter600. The proximal inversion1022acan be positioned approximate the aneurysm neck16. The distal inversion1024adefining the second segment1044acan also begin to form as the braid1010is pushed out of the microcatheter600. As illustrated inFIGS. 18E through 18F, the “S” shape of the second segment1044acan begin to form as the braid1010is further pushed from the microcatheter600.

As illustrated inFIG. 18G, once the first portion of the braid1010, which can comprise the first segment1042a, second segment1044a, and third segment1046a, is in place within the aneurysm sac12, the fourth segment1052acan radially expand outside the aneurysm10as the distal portion of the braid1010continues to exit the microcatheter600.

As illustrated inFIG. 18H, the fourth segment1052acan then be compressed distally as it continues to radially expand, compressing the fourth segment1052aup into the first portion of the braid1010.

Finally, as illustrated inFIG. 18I, the fourth segment1052acan be compressed distally into the first portion of the braid1010, at least partially occluding the neck16of the aneurysm10and the neck opening1026. The pinched end1012and/or the detachment point150can remain external to the aneurysm sac once the fourth segment1052ahas reached its final expanded and compressed state. The fourth segment1052awhen compressed can be compressed to a minimal thickness as to not become an obstruction to the surrounding blood vessels.

Before the implant1000is released from the delivery system, the implant1000can be partially or fully retracted into the microcatheter600and repositioned.

FIG. 19Ais a flow diagram for a method1100for forming an occlusive device to treat an aneurysm10. Step1110includes selecting an implant comprising a tubular braid, an open end, and a pinched end. Step1120includes shaping the tubular braid to a predetermined shape, such as the one illustrated inFIG. 17A. As illustrated inFIG. 19B, step1120can further comprise additional steps. Step1122includes inverting the tubular braid to form a distal inversion. Step1124inverts the tubular braid to form a proximal inversion by moving the open end over at least a portion of the braid. Step1126includes shaping a first segment of the tubular braid extending between the open end and the proximal inversion. Step1128shapes a second segment of the tubular braid extending between the proximal inversion and the distal inversion. Step1130includes positioning the open end to encircle the second segment. Step1132shapes a third segment extending from the distal inversion to the proximal inversion. Step1134includes positioning the second segment to surround the third segment. Step1136shapes a fourth segment of the tubular braid extending from the third segment radially outward from a central axis to cross the proximal inversion, fold inwardly toward the central axis, and converge at the pinched end. Step1138includes positioning the fourth segment approximate a neck of an aneurysm.

In method1100, step1120of shaping the tubular braid to the predetermined shape can further include shaping the fourth segment to comprise a diameter greater than or approximately equal to a maximum diameter of the first segment. In method1100, the step1120of shaping the tubular braid to the predetermined shape can further include shaping the fourth segment to a diameter lesser than a maximum diameter of the first segment. The method1100can further include shaping the tubular braided implant to a delivery shape sized to traverse a lumen of a microcatheter.

FIG. 20Ais a flow diagram for a method1200for a method for treating an aneurysm10. Step1210positions a first portion of a tubular braided implant, the tubular braided implant comprising a tubular braid, an open end, and a pinched end, within a sac of the aneurysm such that the first portion circumferentially apposes walls within the sac. The first portion can include one or more inversions. Step1220includes expanding a second portion of the tubular braided implant radially to occlude a majority of a neck of the aneurysm. Step1230presses the second portion distally into the first portion. Pressing the second portion distally into the first portion can create three layers of braid at the neck of the aneurysm. The second portion can cover any spatial gaps between the first portion and the aneurysm neck, and can potentially increase metal coverage, decrease porosity of the implant, and increase stasis and blood flow diversion at the neck of the aneurysm to promote the sealing and healing of the aneurysm. Step1240includes moving the first portion of the tubular braided implant toward a distal portion of the aneurysm wall as a result of pressing the second portion distally into the first portion.

As illustrated inFIG. 20B, step1220can further include step1222, which includes positioning a fold in the second segment to define a substantially circular perimeter of the second portion. Step1220can additionally, or alternatively include step1224, which includes compressing the second portion along a central axis of the tubular braided implant such that the second portion comprises a substantially circular shape having an area and the second portion comprises two layers of braid over a majority of the area of the substantially circular shape.

Step1210can further include shaping the tubular braided implant to form a columnar post encircling a central axis of the tubular braided implant and extending a majority of a height of the first portion. Step1210can further include positioning a proximal inversion in the first portion of the tubular braided implant approximate the neck of an aneurysm and positioning a distal inversion in the first portion of the tubular braided implant approximate the distal portion of the aneurysm wall. Step1210can further include positioning the open end of the tubular braided implant to circumferentially appose the aneurysm wall, shaping a first segment of the tubular braid extending between the open end and the proximal inversion to appose an at least a portion of a wall of the aneurysm within the aneurysm's sac, and shaping a second segment of the tubular braid such that the first segment provides an outwardly radial force in a plane defining a boundary between the aneurysm and blood vessel branches, the force sufficient to appose the first segment to walls of the aneurysm.

Step1230can further include pressing the second portion of the tubular braided implant against the proximal inversion in the first portion of the tubular braided implant. Step1240can further include moving the distal inversion in the first portion of the tubular braided implant toward the distal portion of the aneurysm wall.

The method1200can further include shaping the tubular braided implant to form a columnar post encircling a central axis of the tubular braided implant and extending a majority of a height of the first portion. The method1200can further include retracting the tubular braid until a desired position is achieved relative to the aneurysm. The method1200can further comprise shaping the tubular braided implant to a delivery shape sized to traverse a lumen of a microcatheter.

FIGS. 21A through 21Bare illustrations of an example braided implant1300as it is formed into a predetermined shape (FIG. 21B). The implant1300can treat a range of aneurysm sizes. The implant1300can include a tubular braid1310having an open end1314and a pinched end1312, similar toFIGS. 17A and 17B. The tubular braid1310can include memory shape material that can be heat set to a predetermined shape, can be deformed for delivery through a catheter, and can self-expand to an implanted shape that is based on the predetermined shape and confined by the anatomy of the aneurysm in which it is implanted.

When in the predetermined shape, the tubular braid1310can be substantially radially symmetrical about a central vertical axis. The implant1300can include a connection and detachment feature150as illustrated in prior figures. The pinched end1312can include a marker band and/or soldered point with visibility, and/or the connection feature150can include radiopaque material. The tubular braid1310can be formed in the predetermined shape (FIG. 21B), collapsed to a delivery shape with a single layer of braid1310for delivery through a microcatheter similar toFIG. 18A, attached to a delivery system at connection feature150, and implanted in an implanted shape such as the ones shown inFIGS. 22A-6Cin a manner similar to the delivery described inFIGS. 18A through 18F.

Referring toFIG. 21A, the tubular braid1310can include two inversions,1322,1324, a pinched end,1312, and an open end1314. The tubular braid1310as depicted inFIG. 21Acan include four segments,1342,1344,1346, and1348. The first segment1342can extend from the open end1314of the tubular braid1310to a proximal inversion1322. The second segment1344can be encircled by the open end1314and can extend from the proximal inversion1322to a distal inversion1324. The third segment1346can be surrounded by the second segment1344.

The tubular braid can be formed into a predetermined shape by first inverting the braid1310outwardly to separate the third segment1346from the second segment1344with a distal inversion1324. Then, the second segment1344can be shaped over a form or mold. The form can be in the shape of a sack. Next, the braid1310can be inverted outwardly again to separate the second segment1344from the first segment1342with a proximal inversion1322.

As further illustrated inFIG. 21A, the third segment1346can span from the distal inversion1324to the ball segment1348. The first segment1342, second segment1344, and third segment1346can form a first portion of the tubular braid1310. The ball segment1348can extend from a proximal portion of the third segment1346radially outward from a central axis of the tubular braid1310to form a substantially ellipsoid shape and converge at the pinched end1312. A mold1320can be applied, and this form wherein the ball segment1348is shaped can be treated with heat in order to set the predetermined shape as depicted inFIG. 21B.

As seen inFIG. 21B, the ball segment1348can be pressed distally into the first portion of the tubular braid1310. When the ball segment1348is pressed distally into the first portion of the tubular braid1310, the ball segment1348can provide a radially outward force to appose the proximal inversion1322. Further, when the ball segment1348is pressed distally into the first portion of the tubular braid1310, the ball segment1348can be at least partially enclosed within the second segment1344distal to the proximal inversion1322. The ball segment1348can also be fully enclosed within the second segment1344distal to the proximal inversion1322. When the tubular braid1310is in the predetermined shape, the second segment1344can form a sack, and at least a portion of the third segment1346can positioned within the sack and at least a portion of the ball segment1348can be positioned external to the sack. The ball segment1348can occlude at least a portion of the proximal inversion1322to seal the opening created by the proximal inversion1322.

FIGS. 22A through 22Care illustrations of an example braided implant1300implanted within an aneurysm10. The tubular braid1310can be radially or vertically compressed or extended compared to the predetermined shape to conform to aneurysms of varying sizes, heights, and shapes. As illustrated inFIG. 22A, when in the implanted shape in an aneurysm10with a height H1, the braid1310can have an outer layer1342acorresponding to the first segment1342of the predetermined shape and positioned to contact an aneurysm wall14of the aneurysm10, a proximal inversion1322acorresponding to the proximal inversion1322of the predetermined shape and positioned to be placed approximate a neck16of the aneurysm10, and a sack1344acorresponding to the second segment1344of the predetermined shape and positioned to appose the outer layer1342a. A distal inversion1324acan correspond to the distal inversion1324of the predetermined shape, and a third segment1346acan correspond to the third segment1346in the predetermined shape. The braid1310can also have a ball segment1348acorresponding to the ball segment1348of the predetermined shape and extending from the third segment1346aradially outward from a central axis to form a substantially ellipsoid shape and converge at the pinched end1312. As described inFIG. 21B, the ball segment1348acan be pressed distally into the first portion of the tubular braid1310. Pressing the ball segment1348adistally into the first portion of the tubular braid1310can result in multiple layers of braid1310seated at the neck16of the aneurysm10. These multiple layers of braid1310can inhibit blood flow into the aneurysm10by better occluding the aneurysm neck16, by better occluding the channel formed by the proximal inversion1322a, or both.

As illustrated inFIG. 22A, when implanted, the ball segment1348acan be positioned external to the aneurysm10, extending across the aneurysm neck16. The ball segment1348acan occlude at least a portion of the aneurysm neck16. The ball segment1348acan also occlude at least a portion of the proximal inversion1322ato seal the opening created by the proximal inversion1322a.

FIG. 22Bdepicts an implant1300in an aneurysm10with a height H2. The height H2of the aneurysm inFIG. 22Bcan be greater than the height H1of the aneurysm inFIG. 6A. By pressing the ball segment1348ainto the first portion of the tubular braid1310within an aneurysm with a height H2, the first portion1342aof the tubular braid1310can be moved further into the aneurysm10towards the distal portion of an aneurysm wall15. The ball segment1348acan occlude at least a portion of the neck16of the aneurysm10. The ball segment1348acan also occlude at least a portion of the proximal inversion1322ato seal the opening created by the proximal inversion1322a. Pushing the ball segment1348ainto the first portion of the braid1310can also appose the proximal inversion1322to provide a radially outward force against the proximal inversion1322so that the tubular braid1310apposes a wall14of the aneurysm10approximate a neck16of the aneurysm10.

Alternatively, pushing the ball segment1348adistally into the first portion of the tubular braid1310can push the third segment1346adistally into the aneurysm towards a distal portion of the aneurysm wall15, independent of distal movement of the outer layer1342aand/or sack1344a. This can extend the height of the implant1300to better conform to the height of the aneurysm H2. At least a portion of the ball segment1348acan be enclosed by the sack1344a. At least a portion of the ball segment1348acan be positioned external to the sack1344a.

As illustrated inFIG. 22C, the implant1300can be deployed within an aneurysm with a height H3greater than H1and H2inFIGS. 22A and 22Brespectively. As seen here, the ball segment1348acan be pushed distally even further into the first portion of the tubular braid1310until it is completely enclosed within the sack1344a. By pressing the ball segment1348ainto the first portion of the tubular braid1310within an aneurysm with a height H3, the first portion1342aof the tubular braid1310can be moved towards the distal portion of an aneurysm wall15. Alternatively, as described inFIG. 22B, pushing the ball segment1348adistally into the first portion of the tubular braid1310can push the third segment1346adistally into the aneurysm towards a distal portion of the aneurysm wall15, independent of distal movement of the outer layer1342aand/or sack1344a. This can extend the height of the implant1300to better conform to the height of the aneurysm H3. The ball segment1348acan occlude at least a portion of the aneurysm neck16. The ball segment1348acan also occlude at least a portion of the proximal inversion1322ato seal the opening created by the proximal inversion1322a. In this way, the implant1300can be used to treat implants of varying heights and widths depending on the positioning of the ball segment1348relative to the first portion of the braid1310.

FIG. 23is a flow diagram for a method1400for treating an aneurysm10. The method1400can be utilized to treat aneurysms of varying sizes, heights, and shapes with a single device. Step1410positions a first portion of a tubular braided implant, the tubular braided implant having a tubular braid, an open end, and a pinched end, within a sac of the aneurysm such that the first portion circumferentially apposes walls within the sac. The first portion can include one or more inversions, including a distal inversion approximate a distal portion of the aneurysm wall. Step1420includes expanding a second portion of the tubular braided implant in connection with the first portion of the tubular braided implant radially to occlude a majority of the neck of the aneurysm. Step1430presses the second portion distally into the first portion to provide a radial force against the first portion towards the aneurysm wall approximate the neck of the aneurysm in a plane defining a boundary between the aneurysm and blood vessel branches. Lastly, Step1440moves the distal inversion toward a distal portion of the aneurysm wall as a result of pressing the second portion distally into the first portion.

The step1410of positioning the first portion of the tubular braided implant can further include positioning the open end of the tubular braided implant to circumferentially appose the aneurysm wall, positioning a proximal inversion in the first portion of the tubular braided implant approximate the neck of an aneurysm; and shaping a first segment of the tubular braid extending between the open end and the proximal inversion to appose an at least a portion of a wall of the aneurysm within the aneurysm's sac.

The step1420of expanding the second portion of the tubular braided implant can further include compressing the second portion along a central axis of the tubular braided implant such that the second portion forms a substantially ellipsoidal shape.

The step1430of pressing the second portion distally into the first portion can further include apposing at least a part of the first portion with the second portion to provide an outwardly radial force along a central axis of the tubular braided implant from the second portion to the first portion. The step1430of pressing the second portion distally can also involve pressing the second portion of the tubular braided implant against the proximal inversion in the first portion of the tubular braided implant until the second portion of the tubular braided implant is at least partially enclosed by the proximal inversion. The step1430of pressing the second portion distally can also disrupt the flow of blood into the aneurysm by placing multiple layers of braid approximate the neck of the aneurysm.

The method1400can further include shaping the tubular braided implant to a delivery shape with a single layer of braid sized to traverse a lumen of a microcatheter.

FIG. 24is a flow diagram for a method of forming an occlusive device to treat an aneurysm. The method can include inverting a tubular braid comprising an open end and a pinched end to form a distal inversion (1510); inverting the tubular braid to form a proximal inversion by moving the open end over at least a portion of the braid (1520); shaping a first segment of the tubular braid extending between the open end and the proximal inversion (1530); shaping a second segment of the tubular braid extending between the proximal inversion and the distal inversion (1540); positioning the open end to encircle the second segment (1550); shaping a third segment extending from the distal inversion to the pinched end (1560); positioning the second segment to surround the third segment (1570); shaping a ball segment of the tubular braid extending from the third segment radially outward from a central axis to form a substantially ellipsoid shape and converge at the pinched end (1580); and applying a mold to the ball segment of the tubular braid and treating the ball segment with heat to conform the ball segment to the formed shape, the ball segment movable along a central axis of the tubular braid (1590).

The method1500can further include positioning the first segment, second segment, and third segment within an aneurysm, and advancing the ball segment distally into the proximal inversion. This step of advancing the ball segment distally into the proximal inversion can move the distal inversion towards a distal portion of a wall of the aneurysm, which can conform the device to the height of the aneurysm. In this manner, the device can be used to treat aneurysms of varying heights, shapes, and sizes.

The method1500can also include apposing the proximal inversion with at least a portion of the ball segment. The method1500can further include moving the ball segment to a position at least partially enclosed by the second segment distal to the proximal inversion. The method1500can also involve retracting the tubular braid until a desired position is achieved relative to the aneurysm.

In known treatments of wide neck aneurysms, the aneurysm is typically treated by placing embolic coils within the aneurysm sac and placing a stent within the parent blood vessel across the aneurysm neck. The stent is necessary in many cases to inhibit the embolic coils from entering the parent blood vessel. If embolic coils enter the parent blood vessel, the coils can obstruct the vessel and/or clots can form on the coils within the blood vessel and create an obstruction in the parent blood vessel. Braided aneurysm intrasaccular implants can be used to treat wide neck aneurysms without requiring a stent to secure the braided implant at the aneurysm neck. However, to achieve the forces necessarily to anchor braided implants in a wide neck bifurcation, the braid can be stiff and resistant to reshaping to an implanted shape that is significantly different than a predetermined shape. It can therefore be challenging, in some cases, to pack the aneurysm with a sufficient braid density to quickly and effectively induce blood stasis within the aneurysm sac. A braid made too soft can compact in shape and cause the aneurysm to recanalize as the implant is no longer sealing the neck of the aneurysm.

Aspects of the present invention are directed to address the above challenges. In examples presented herein, a tubular braided implant can include a braid that can be delivered as a single layer braid, can invert into itself during deployment to form at least two nested sacks, and can include additional braid material that can fill the innermost sack. The additional braid material can loop or coil like a ribbon and/or invert to form smaller and smaller nested sacks. An aspect of the present invention is to provide a structure that allows a sufficient amount of additional braid material to be placed into the innermost sack such that the aneurysm clots quickly for an effective treatment.

When used herein, the terms “tubular” and “tube” are to be construed broadly and are not limited to a structure that is a right cylinder or strictly circumferential in cross-section or of a uniform cross-section throughout its length. For simplicity, tubular structures are generally illustrated herein as having a substantially right cylindrical structure. However, a tubular structure can have a tapered or curved outer surface without departing from the scope of the present invention.

To meet the competing needs for braid stiffness to achieve secure anchoring within the aneurysm and braid softness to deform the braid to a high packing density within the aneurysm, the braid can be made such that portions of the braid pushed into the aneurysm when the aneurysm has a higher packing density are weaker compared to stiffer portions of the braid that expand to anchor the braid within the aneurysm. Stiffness/flexibility of the braid portions can be controlled by braid angle (e.g. picks per inch), strand diameter, number of strands, material of strands, and/or treatment (e.g. heat treatment) to modify strand material properties, etc. A stiffer portion can have a higher braid angle, a larger strand diameter, more strands, strands comprising a stiffer material, and/or strands treated to have greater stiffness compared to a weaker portion.

Stiffer portions of the braid can be positioned near a distal end of the braid when the braid is being delivered through a catheter so that the stiffer portions of the braid exit the catheter and expand to anchor in the aneurysm before the aneurysm is packed. Stiffer portions of the braid can be shaped in a predetermined shape by heat setting or other means such that when the stiffer portions, they expand toward the predetermined shape. The tendency of the stiffer portions of the braid to expand toward the predetermined shape can create sufficient force against the aneurysm walls to anchor the braid in the aneurysm sac. Weaker portions of the braid can be positioned near the proximal end of the braid when the braid is delivered through the catheter. Portions of the braid which have the most flexibility can be dynamically deformed to loop or nest within the aneurysm, folding within the stiffer, anchoring portions of braid.

In addition, or as a replacement for the braid material that fills the innermost sack, the implant can include an embolic coil that can loop within the innermost sack.

Examples presented herein generally include a braided implant that can secure within an aneurysm sac and occlude a majority of the aneurysm's neck. The implant can include a tubular braid having a stiffer portion and a weaker portion, at least the stiffer portion being set into a predetermined shape, the braid being compressible for delivery through a microcatheter, and the braid being implantable in an implanted position that is based on the geometry of the aneurysm in which the braid is implanted and based at least in part on the predetermined shape.

An example implant1600, as illustrated inFIG. 25can include a braid1610that can be shaped into a substantially tubular, single layer shape having a length L measured between each end1612,1614and a variable stiffness along the length L. As illustrated, stiffness can be determined at least in part by braid angle θ1, θ2, θ3, θ4. For ease of discussion, weaker, more flexible portions of braid are illustrated as having a lower braid angle compared to stronger, stiffer portions of the braid; however, weaker and stiffer portions of the braids can differ in strand diameter, number of strands, material of strands, be treated to have differing stiffness/flexibility, and/or by other means as would be appreciated and understood by a person of ordinary skill in the art. Further, example implants comprising braid segments of differing stiffness can include two separate sections joined to form a braid, and the braid need not include the segments of differing stiffness as a contiguous braided tube.

In the single layer tubular shape illustrated inFIG. 25, the braid1610can have a circumference C that is substantially uniform along the length L. The tubular shape can have a central axis A extending along the length of the braid1610. A braid angle θ1, θ2, θ3, θ4can be measured by comparing the tangential trajectory of a braid strand to the central axis A as illustrated and as would otherwise be understood by a person of ordinary skill in the art according to the teachings herein.

The braid can include a number of strands, for example, from about 4 to about 96 strands, each extending from one braid end1612to the other1614. As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. The strands can wrap helically around the circumference C. The number of strands, angle of strands, diameter of the strands, material of strands, and material properties of strands, can all be factors in controlling material properties of the braid1610, including porosity and flexibility. Braid strands can be woven such that about half of the strands wrap in a clockwise helix, the other half wraps in a counterclockwise helix, and the oppositely wrapping strands cross over and under each other in an alternating fashion. Constructed as such, portions of the braid having a higher braid angle can therefore having a higher density of strands compared to portions of the braid having lower braid angle. Higher strand density can result in a denser, stiffer braid portion.

The strands can be made from multiple alloys such as a nickel-titanium alloy, cobalt chromium alloys, platinum, nitinol, stainless steel, tantalum, or other alloys, or any other suitable biocompatible materials, or combination of these materials. Also, these materials can be absorbable or non-absorbable by the patient over time. Some or all of braid1610can be a multi-filament cylindrical mesh made preferably of nitinol with interwoven platinum filaments for radiopacity or Drawn Filled Tube (DFT) Nitinol with about 10 to about 40% platinum. The apertures in the mesh of braid1610can also create a substantially unitary framework or mesh. Thus, the apertures can have variable size, shape, or porosity, and may be uniformly or randomly spaced throughout the wall of the mesh of braid1610. The apertures can provide the braid1610with flexibility and also assist in the transformation of the braid from the collapsed state to the expanded, deployed state, and vice versa.

The braid1610as illustrated inFIG. 25depicts four braid angles θ1, θ2, θ3, θ4that increase as measured from the proximal end1612of the braid1610to the distal end1614with the braid angle θ4in the proximal portion1616of the braid1610being the smallest, the braid angle θ3in the section immediate distal to the proximal portion1616being larger than the braid angle θ4in the proximal portion1616, the braid angle θ2in the next distal section being larger than the angle θ3in the section immediately proximal to it, and the braid angle θ1in the distal most section1618of the braid1610being the largest. As would be appreciated and understood, the braid1610can include two or more sections having differing braid angles and thereby differing stiffness/flexibility. The braid can additionally include a continuous gradient change in braid angle and thereby continuous gradient change in stiffness/flexibility from one braid section to another, for instance the braid angle can change continuously from the proximal portion1616to the distal portion1618.

The implant1600can be delivered to an aneurysm when the braid1610is sized to traverse a catheter. For instance, the braid1610can be delivered in the single-layer tubular shape as illustrated inFIG. 25such that one end of the braid1614is a distal end positioned to exit the catheter before the remainder of the braid1610and the other end1612is a proximal end positioned to exit the catheter after the remainder of the braid1610. Alternatively, the braid can be delivered in other shapes that include folds, inversions, and/or multiple layers. Regardless of the delivery shape, the braid1610can have a distal portion1618positioned to exit the catheter before the remainder of the braid1610and a proximal portion1616positioned to exit the catheter after the remainder of the braid1610. The distal portion1618can have a high braid angle θ1such that the distal portion1618has sufficient stiffness to anchor the braid1610within the aneurysm. The proximal portion1616can have a low braid angle θ4such that the proximal portion has sufficient flexibility to collapse into an aneurysm sac containing the remainder of braid1610. The implant1600can further include a detachment feature150configured to be detachably attached to an implant delivery system. The detachment feature150can be affixed to the braid1610at the proximal end1612of the braid1610.

FIG. 26illustrates a braid1610such as the braid1610illustrated inFIG. 25shaped into a predetermined shape. The braid1610can include a memory shape material such as Nitinol, a Nitinol alloy, a polymer memory shape material, or other memory shape material having properties for reshaping as described herein. The braid1610can be set to the predetermined shape by heat setting or other means as appreciated and understood by a person of ordinary skill in the art. The braided segment1610can be collapsed from the predetermined shape to a deformed shape sized to traverse a microcatheter to an aneurysm. Upon contact with blood when exiting the microcatheter, the braid1610can move from the deformed shape toward the predetermined shape. The anatomy of the aneurysm and treatment site can inhibit the braid1610from moving to the predetermined shape such that when the braid1610is deployed, it can take on a deployed shape that is based in part on the predetermined shape and the shape of the anatomy in which the braid is implanted.

In the predetermined shape, the braid1610can include two inversions1622,1624and a pinch point1626dividing the braid1610into four segments1642,1644,1646,1630. In the predetermined shape, the braid1610can have an outer segment1642extending from the open end1614of the braid1610to a first inversion1622of the two inversions1622,1624, a middle segment1644extending between the two inversions1622,1624, an inner segment1646extending from a second inversion1624of the two inversions1622,1624to the pinched point1626of the braid1610, and an elongated section1630extending from the pinch point1626to an opposite end1612of the braid1610. When in the predetermined shape, the tubular braid1610can be substantially radially symmetrical around a central vertical axis y.

FIG. 26illustrates a profile of each segment1642,1644,1646,1630. The detachment feature150is illustrated as a flat key that can be used with a mechanical implant delivery system (not illustrated). Example implant delivery systems are described, for instance, in U.S. Patent Application Publication Number 2019/0192162 and U.S. Patent Application Publication Number 2019/0328398 each incorporated herein by reference as if set for in their entireties herein. During delivery and/or positioning of the implant, the key150can be visualized radiographically. The key150can be released from the delivery system, thereby releasing the implant1600from the delivery system. When the implant is released, the key can remain attached to the implant.

The tubular braid1610can be formed into the predetermined shape by first pinching the braid1610at the pinch point1626, then inverting the braid outwardly to separate the inner segment1646from the middle segment1644with an inversion1624, then shaping the middle segment1644over a form to produce the substantially “S” shaped profile illustrated, and finally, inverting the braid1610outwardly again to separate the middle segment1644from the outer segment1642with another inversion1622. Optionally, the braid can be trimmed at the open end1614and/or the proximal end1612. The open end1614can be positioned to encircle the middle segment1644. The open end1614can positioned within the middle third section of the braid's height as illustrated. Alternatively, the open end1614can be positioned elsewhere, such as near the distal inversion1624.

The outer sack1642can correspond to the distal portion1618of the braid1610as illustrated inFIG. 25. The distal portion1618can have a substantially uniform braid angle θ1along its length when the single layer tubular shape illustrated inFIG. 25The braid1610can have an abrupt braid angle change at the proximal inflection1622. The braid1610can have a graduated braid angle change through the middle section1644and inner section1646. The tail1630can have a braid angle θ4that is substantially consistent along the length of the tail1630. The tail1630can correspond to the proximal portion1616of the braid1610in the single layer tubular shape as illustrated inFIG. 25.

Alternatively, sections1642,1644,1646distal to the pinch point1626can have a high braid angle θ1that is consistent along the length of those sections1642,1644,1646when the braid1610is in a single layer tubular shape, the tail section1630can have a low braid angle θ4consistent along its length, and the braid1610can have an abrupt change in braid angle at the pinch point1626. The tail1630can be sufficiently flexible such that, when manipulated at an intravascular treatment site, it flattens to a ribbon shape and folds onto itself. Alternatively, braid1610can include an abrupt braid angle change at the proximal inflection1622, at the distal inflection1624, at the pinch point1626, or any combination thereof.

Strands of the braid1610at the open end1614can be free, cut ends; or, alternatively, the strands at the open end1614be closed, meaning strands within the braid at the open end1614are attached to each other by glue, weld, etc. or the strands bend back at the open end1614. Free cut ends can have an advantage of being easier to manufacture while the closed strand ends can have an advantage of being more atraumatic compared to the cut ends.

FIGS. 27A through 27Iillustrate an implant1600such as the implant1600illustrated inFIGS. 25 and/or 26being implant in an aneurysm10via a catheter600. The size of the catheter600can be selected in consideration of the size, shape, and directionality of the aneurysm or the body lumens the catheter must pass through to get to the treatment site. The catheter600can have a total usable length from about 80 centimeters to about 170 centimeters. The catheter600can have an inner diameter ID of from about 0.015 to about 0.032 inches. The outer diameter OD can also range in size and may narrow at either its proximal end or distal end. At its proximal end26, the catheter600can be manually operated by the end-user, and at its distal end can be operable, as illustrated, to be positioned at the neck16of the aneurysm10. While the distal end of the catheter600can contain the implant1600, the distal end can be varied in shape and can curve at an angle.

FIG. 27Aillustrates the open end1614of the braid1610expanding within a sac12of the aneurysm10to contact walls14of the aneurysm10. The section1642′ contacting the aneurysm wall14can correspond to the outer1642section in the predetermined shape illustrated inFIG. 26and/or the distal, stiffer portion1618of the braid1610illustrated in FIG.25. The implant1600can be selected for treatment such that the selected implant1600has an outer segment1642in the predetermined shape having a circumference greater than the circumference of the aneurysm sac12, meaning the section1642′ of the braid1610contacting the aneurysm wall provides a force against the aneurysm wall14as it tends to expand to the predetermined shape. The implanted shape of the outer section1642′ can thereby be smaller in circumference than the predetermined shape of the outer section1642.

FIG. 27Billustrates the braid1610inverting to form a proximal inversion1622′ in the implanted shape. The proximal inversion1622′ can correspond to the proximal inversion1622in the predetermined shape.

FIG. 27Cillustrates the braid1610expanding within the outer section1642′.

FIG. 27Dillustrates the braid forming an inner sack1644′ inside of the outer section1642′. A distal inversion1624′ is illustrated positioned near a distal portion15of the aneurysm wall14. The distal inversion1624′ can correspond to a distal inversion1624of the braid1610in the predetermined shape. The inner sack1644′ can correspond to the middle segment1644in the predetermined shape illustrated inFIG. 26. The inner sack1644′ can correspond to the stiff, distal portion1618of the braid1610illustrated inFIG. 25and/or a portion of the braid1610having less stiffness than the distal portion1618. The inner sack1644′ can correspond to a portion of the braid1610having greater stiffness than the flexible proximal portion1616illustrated inFIG. 25.

FIG. 27Eillustrates a collapsible portion1646′ of the braid1610further exiting the catheter20and expanding within the inner sack1614′. The collapsible portion1646′ can correspond to the inner segment1646of the braid1610in the predetermined shape. The collapsible portion1646′ can correspond to the stiff, distal portion1618of the braid1610illustrated inFIG. 25and/or a portion of the braid1610having less stiffness than the distal portion. The collapsible portion1646′ can correspond to a portion of the braid1610having greater stiffness than the flexible proximal portion1616illustrated inFIG. 25.

FIG. 27Fillustrates the collapsible portion1646′ forming a dome near the distal inversion1624′. A pinch point1626′ is illustrated on the proximal side of the dome formed by the collapsible portion1646′. The pinch point1626′ in the implanted shape can correspond to the pinch point1626in the predetermined shape.

FIG. 27Gillustrates a proximal tail1630′ of the braid1610flattening to a ribbon shape and folding within a space defined by the inner sack1644′ and the dome of the collapsible portion1646′. The proximal tail1630′ can correspond to the proximal tail1630of the braid in the predetermined shape as illustrated inFIG. 26. The proximal tail1630′ can correspond to the flexible, proximal portion1616illustrated inFIG. 25.

FIG. 27Hillustrates additional length of the proximal tail1630′ folding within the space defined by the inner sack1644′ and the dome of the collapsible portion1646′.

FIG. 27Iillustrates the implant1600in a final implanted shape. The outer section1642′, inner sack1644′, and collapsible portion1646′ are illustrated in cross-section to better illustrate the folded ribbon shape of the proximal tail1630′.

FIG. 28illustrates an alternative implanted shape of a braid1610. As illustrated inFIG. 28, the braid1610can include a twist1625near the distal inversion1624′. Either with the twist1625as illustrated inFIG. 28, or without the twist, as illustrated inFIG. 27I, the inner sack1644′ can provide a force F1pressing into the aneurysm wall14and/or the outer section1642′, depending on the coverage of the outer section1642′. The outer section1642′ is also illustrated in an alternative configuration such that the open end1614is positioned approximate the distal portion15of the aneurysm wall14.

FIGS. 29A and 29Billustrate subsequent implantation steps of the implant1600illustrated inFIG. 28.FIG. 29Aillustrates a second inner sack1632expanding within the aforementioned, first sack1642′.FIG. 29Billustrates the second inner sack1632providing a second force F2pressing into the first sack1642′. The braid1610is illustrated in cross section inFIG. 29B. In subsequent implantation steps, the braid1610can form additional nested sacks. Additionally, or alternatively, the braid can collapse to form a ribbon shape and fold into a space defined by one or more nested sacks similar to as illustrated inFIGS. 27G through 27I.

FIG. 30illustrates an alternative implant1600aincluding a braid1610having two sections1616,1618of differing braid angle θ1, θ4, an embolic coil1660, and a detachment key150. The embolic coil1660can be attached to a proximal end1612of the braid1610. A proximal portion1616of the braid1610near the proximal end1612can have a small braid angle θ4. A distal portion1618of the braid1610near the distal end1614of the braid can have a larger braid angle θ4. The braid1610can be shaped into a single layer tubular shape as illustrated inFIG. 30. The braid can be shaped for delivery as described elsewhere herein.

FIG. 31illustrates an alternative implant1600asuch as the implant1600aillustrated inFIG. 30having a braid1610in a predetermined shape. The predetermined shape can have four sections1642,1644,1646,1630, two inversions1622,1624, and a pinch point1626similar to as described in relation toFIG. 26. The embolic coil1660can extend from the tail section1630of the braid1610. When implanted, the embolic coil1660can take the place of some or all of the tail portion1630′ of the implant1600illustrated inFIG. 27I.

FIG. 32illustrates an implant1600asuch as the implant1600aillustrated inFIG. 30and/orFIG. 31in an implanted shape. The braid1610can have an outer section1642′ and an inner sack1644′ when implanted similar as disclosed in relation toFIG. 27Iand/orFIG. 28. The embolic coil1660can wind within the inner sack1644′.

FIG. 33is a flow diagram outlining example method steps for treating an aneurysm with an implant and/or system such as an example implant1600,1600aand/or system described herein, variations thereof, or alternative implant and/or system as would be appreciated and understood by a person ordinary skill in the art.

Referring to method1700outlined inFIG. 33, in step1702a tubular braid having a stronger section and a weaker section can be selected. The selected tubular braid can include an example tubular braid1610as described herein, a variation thereof, or an alternative thereto as would be appreciated and understood by a person of ordinary skill in the art. The stronger section can have a larger braid angle relative to the weaker section such that the strength of the braid sections is respectively determined at least in part by the respective braid angles. Additionally, or alternatively, one or both of the stronger and weaker sections can be treated (e.g. heat treated) to modify material properties of one or both of the sections such that difference in strength between the two sections is determined at least in part by the treatment. Additionally, or alternatively, the stronger section can have a greater number of strands compared to the weaker section such that the strength of the braid sections is respectively determined at least in part by the number of strands. Additionally, or alternatively, the strands in the stronger section can have a larger diameter compared to the diameter of the strands in the weaker section such that the strength of the braid sections is respectively determined at least in part of the diameter of the strands. Additionally, or alternatively, the strands in the stronger section and the weaker section can include differing materials such that the strength of the sections is respectively determined at least in part by the material properties of the strands.

In step1704, the braid can be delivered through a microcatheter to an aneurysm. The braid can be detachably attached to an elongated delivery system. The implant (and thereby the braid) can be attached to the delivery system at a distal end of the delivery system. The delivery system and the implant can be positioned within the microcatheter such that the delivery system extends from a proximal end of the microcatheter. A user (e.g. physician) can deliver the implant through the microcatheter by manipulating the portion of the delivery system that extends out of the proximal end of the microcatheter. A user can place the implant similar to as illustrated inFIGS. 27A through 27I,FIG. 28,FIGS. 29A through 29B, and/orFIG. 32, otherwise described herein, or as otherwise understood by a person of ordinary skill in the art according to the teachings herein by manipulating the portion of the delivery system extending from the proximal end of the microcatheter.

In step1706, the distal end of the braid can be positioned at a distal portion15of the aneurysm wall14. The distal end of the braid can be positioned as illustrated inFIG. 28,FIGS. 29A through 29B, and/orFIG. 32. Alternatively, the distal end of the braid can be positioned elsewhere, for instance within a middle third of the aneurysm wall14, about halfway between the distal portion15of the wall14and the aneurysm neck16as illustrated inFIGS. 27A through 27I.

In step1708, the stronger section of the braid can be expanded to form an outer sack apposing the aneurysm wall14. The outer sack can be shaped similar to the outer sack1642′ illustrated inFIG. 28,FIGS. 29A through 29B, and/orFIG. 32. Alternatively, the stronger section of the braid can be expanded to form a bowl shape similar to the outer section1642′ shape illustrated inFIGS. 27A through 27I.

In step1710, a proximal inversion can be formed in the braid at the aneurysm's neck. The proximal inversion can be positioned similar to the proximal inversion1622′ illustrated inFIGS. 27A through 27I,FIG. 28,FIGS. 29A through 29B, and/orFIG. 32. The proximal inversion can be shaped similar to the proximal inversion1622′ illustrated inFIGS. 27A through 27I,FIG. 28,FIGS. 29A through 29B, and/orFIG. 32. The proximal inversion1622′ can define a boundary between the outer sack or outer section expanded in step1708and an inverted portion positioned within the outer sack or outer section.

In step1712, the inverted portion can be expanded to form a sack inside the outer sack or outer section. The inverted portion can press against the outer sack (or section), thereby pressing the outer sack (or section) into the aneurysm wall14. The inverted portion can form an inner sack1644′ such as illustrated inFIGS. 27A through 27I,FIG. 28,FIGS. 29A through 29B, and/orFIG. 32.

In step1714, a distal inversion can be formed in the braid. The distal inversion can define a distal side of the inverted, inner sack expanded in step1712. The distal inversion can define a boundary between the inner sack and an inner, non-inverted portion of the braid. The inner, non-inverted portion of the braid can include the weaker section of the braid.

In step1716, the weaker section of the braid can be positioned in the inverted sack. The weaker section can be flattened to a ribbon shape and folded into the inverted sack. The weaker section can be flattened and folded such as illustrated inFIGS. 27G through 27I, as otherwise described herein, and/or as understood by a person of ordinary skill in the art according to the teachings herein. The weaker section can correspond to the tail section1630,1630′ of the braid1610.

FIGS. 34A through 34Dare illustrations of steps of an aneurysm treatment process.FIG. 34Aillustrates an implant100being implanted in an aneurysm10. To achieve the implanted shape illustrated inFIG. 34A, the implant100can be implanted similar to as illustrated inFIGS. 3A through 3For through similar methods for other example implants described herein. As implanted, the braid110includes a sack144a. The braid can be delivered in a delivery configuration having an exterior surface and inverted to form the sack144aso that the exterior surface of the braid in the delivery configuration corresponds to an interior surface of the sack144a. The detachment feature150is detached so that the implant is positioned within the aneurysm10absent interaction with a delivery system or other implant manipulation apparatus. The braid can be allowed to remain self-anchored in the aneurysm10in preparation for steps illustrated inFIGS. 34B through 34D.

FIG. 34Billustrates a catheter600being inserted into a neck opening126aof the implant100. The catheter600can be the same catheter through which the implant100was delivered or a different catheter. The catheter600can have an outer diameter (OD) sized to be inserted through the neck opening126ainto the sack144aof the braid110. The neck opening126acan be resilient so that it is capable of expanding to receive the catheter600and collapsing to a smaller diameter when the catheter600is removed. The braid110can include embolic material onto which thrombotic material may accumulate. The catheter600is preferably inserted into the neck opening126aprior to thrombotic material accumulating to inhibit the neck opening126afrom expanding to receive the catheter600.

FIG. 34Cillustrates embolic coils602being inserted into a sack144aof the braid110via the catheter600. The embolic coils602can at least partially fill the sack144aof the implant100. The embolic coils602can press outwardly to anchor the implant100into aneurysm walls14. The sack144aand outer layer142aof the braid110can act as a container to inhibit the coils602from exiting the aneurysm sac12. The coils602can aid in occluding the aneurysm10as there is more embolic material in the aneurysm. The coils602can also be used to inhibit compaction of the braid110. This method can also be used if the aneurysm recanalizes, allowing the physician to place embolic material in areas that did not occlude. Other embolic material can be used in place of the embolic coil602such as foam, glue, or biodegradable material to aid in occlusion of the aneurysm10and/or resist compaction of the braid110. In some examples, the braid110at the proximal inversion122acan have a pore size that is sufficiently small to inhibit blood flow near the aneurysm neck16where the aneurysm10lacks coils602. In this case, the method of treatment can cease without proceeding to the step illustrated inFIG. 34D.

FIG. 34Dillustrates the catheter600repositioned to extend through openings of the mesh of the braid110approximate the aneurysm neck16, at the proximal inversion122aof the braid110. Embolic coils602are being inserted between the outer layer142aand sack144a. As illustrated, the braid110, at the proximal inversion122a, has a pore size approximately equal to the outer diameter OD of the catheter600or larger so that the catheter600can be inserted through the mesh at the proximal inversion122a. Generally, a larger pore size can allow the braid110to have a smaller diameter during delivery and/or be more flexible compared to some braids having a smaller pore size. The larger pore size can therefore allow the braid110to traverse vasculature more easily than a braid having a smaller pore size. When coils602are relied upon to arrest blood flow into the aneurysm as illustrated, the braid110can be relied on primarily to cage the coils602and the ability of the braid110itself to arrest blood flow is less consequential.

The porosity of the braid110can be uniform or can vary along its length. Variation in pore sized can be accomplished by change in braid angle and/or variation in number of braid strands. For example, in a treatment that ceases at the step illustrated inFIG. 34C, the braid110can have small pores in a portion that includes the proximal inversion122aand nearby braid that is likely to cross the aneurysm neck16, and larger pores elsewhere. In this example, the braid110can be more easily delivered compared to a braid having uniform porosity with smaller sized pores at the proximal inversion122a, and the small pores at the aneurysm neck16can be effective to arrest blood flow into the aneurysm10. In another example, in a treatment that includes the step illustrated inFIG. 34D, the braid110can have large pores in the portion that includes the proximal inversion122aand nearby braid that is likely to cross the aneurysm neck16and smaller pores at least in a portion of the braid including the distal inversion124aand braid likely to contact the aneurysm wall14. In this example, when the aneurysm is ruptured, the braid portion having smaller pores at the distal inversion124acan be effective to clot the rupture and stop bleeding prior to delivery of the coils602, while the braid portion at the proximal inversion122aallows packing of coils602at the aneurysm neck16. As another example, in a treatment that ceases at the step illustrated inFIG. 34C, the braid can have small pores at the proximal inversion122aand the distal inversion124aand larger pores elsewhere.

Although the implant100has a similar implanted shape to that illustrated inFIG. 1B, other implants having an opening into a sack can similarly receive embolic coils602. The catheter600can be navigated around the compaction resistant post248a,446a,846of the implants200,400illustrated inFIGS. 7B, and 9Bto place embolic coils602into the respective sacks244a,444aand similarly for the implant800illustrated inFIG. 14. Embolic coils602can be implanted in lobes of the sack344a,944aof the implants300,900illustrated inFIGS. 8B, 16A, and 16B. Embolic coils602can be implanted in the inner sack544aof the implant500illustrated inFIG. 12Cand similarly for the implant700illustrated inFIG. 13. The catheter600can be navigated around the ball segment1348ato place embolic coils602within the sack1344aof the implant1300illustrated inFIG. 22C. Embolic coils602can be added further fill the sack1644′ of implants1600,1600aillustrated inFIGS. 27I, 29B, and 32. Embolic coils602can be positioned within sacks1844a,1944a,2044aof implants1800,1900,2000illustrated inFIGS. 35B, 36B, and 37B.

FIGS. 35A, 36A, and 37Aare each illustrations of a respective implant1800,1900,2000having another respective alternative predetermined shape. Variations in predetermined shape respectively result in differing implanted shapes as illustrated inFIGS. 35B, 35C, 36B, 36C, 37B and 37C. The implanted shapes illustrated inFIGS. 35C, 36C, and 37Cinclude a twist at each of their respective neck openings1826b,1926b,2026bwhile the implanted shapes illustrated inFIGS. 35B, 36B, and 37Black such a twist at their respective neck openings1826a,1926a,2026a. The twist can be incorporated into the shape of the predetermined shape (not illustrated) and/or can be accomplished by manipulating features of the braid such as braid angle or braid wire shape at the neck opening1826,1926,2026.

Similar to the implant100illustrated inFIG. 6A, each implant1800,1900,2000as illustrated inFIGS. 35A, 35B, 36A, 36B, 37A, and 37Bcan each include a respective tubular braid1810,1910,2010having an open end1814,1914,2014and a pinched end1812,1912,2012. Each implant1800,1900,200can include a detachment feature150attached to the braid1810,1910,2010at the pinched end1812,1912,2012. The tubular braid1810,1910,2010can be formed in the respective predetermined shape, collapsed for delivery through a microcatheter, attached to a delivery system at the detachment feature150, and implanted in a shape similar to as illustrated inFIGS. 35B, 35C, 36B, 36C, 37B, and 37Crespectively.

When in the predetermined shape, the tubular braid1810,1910,2010of each respective implant1800,1900,2000can include two inversions1822,1824,1922,1924,2022,2024dividing the braid1810,1910,2010into three segments1842,1844,1846,1942,1944,1946,2042,2044,2046. In the predetermined shape, each respective braid1810,1910,2010can have an outer segment1842,1942,2042extending from the open end1814,1914,2014of the braid1810,1910,2010to one of the inversions1822,1922,2022, an inner segment1846,1946,2046extending from the pinched end1812,1912,2012of the respective braid1810,1910,2010to the other of the inversions1824,1924,2024, and a middle segment1844,1944,2044extending between the two inversions1822,1824,1922,1924,2022,2024. When in the predetermined shape, each tubular braid1810,1910,2010can be substantially radially symmetrical about a central vertical axis y.FIGS. 35A, 36A, and 37Aeach illustrate a profile of each segment1842,1844,1846,1942,1944,1946,2042,2044,2046for each respective braid1810,1910,2010, and the detachment feature150is illustrated as a flat key that can be used with a mechanical implant delivery system (not illustrated).

The tubular braids1810,1910,2010can be formed into the predetermined shape similar to methods described elsewhere herein. Each tubular braid1810,1910,2010can include memory shape material that can be heat set to a predetermined shape, can be deformed for delivery through a catheter, and can self-expand to an implanted shape that is based on the predetermined shape and confined by the anatomy of the aneurysm10in which it is implanted.

The general dimensions of each implant1800,1900,2000in the predetermined shape can be described in relation to heights H1, H2, H3and diameters D1, D2as illustrated inFIG. 6A. In the implanted shapes illustrated inFIGS. 35B, 36B, and 37B, the aneurysm10has a diameter DA that is approximately equal to or smaller than the diameter D1of the outer segment1842,1942,2042and the diameter D2of the middle segment1844,1944,2044of the braids1810,1910,2010in their respective predetermined shapes.

It can be advantageous to minimize a neck opening1826,1926,2026in the respective braid1810,1910,2010to maximize occlusion of an aneurysm neck16when the respective implant1800,1900,2000is implanted. Each braid1810,1910,2010is illustrated as having a tubular neck opening1826,1926,2026in the predetermined shape having a height H4and a diameter D3. The neck openings1826,1926,2026can respectively be configured to constrict when the respective braid1810,1910,2010is implanted. As illustrated inFIGS. 35B, 36B, and 37B, the neck openings1826a,1926a,2026aare constricted compared to their predetermined shape, and can be pushed open by the catheter600so that embolic coils602can be implanted in each respective braid sack1844a,1944a,2044asimilar to as illustrated inFIG. 34C. The neck openings1826a,1926a,2026acan resiliently collapse once the catheter600is removed. As illustrated inFIGS. 35C, 36C, and 37C, the neck openings1826b,1926b,2026bare twisted to further constrict the entrance to each respective braid sack1844a,1944a,2044a. Preferably, the twisted constriction is resistant to opening. In some examples, the twisted neck opening1826b,1926b,2026bcan be so resistant to opening that a catheter600is not able to pass through the twisted neck opening1826b,1926b,2026binto the braid sack1844a,1944a,2044a. In such examples, where the braid1810,1910,2010is configured to cage embolic coils602, the braid1810,1910,2010can include large pores through which the catheter600can be inserted to implant coils in the braid sack1844a,1944a,2044aand/or between the sack1844a,1944a,2044aand outer layer1842a,1942a,2042a.

FIG. 35Aillustrates an implant1800having a neck opening1826with height H4than is elongated compared to the neck openings1926,2026of the implants1900,2000illustrated inFIGS. 36A and 37A. As a result, a braid segment1852surrounding the neck opening1826forms an elongated column when implanted as illustrated inFIG. 35B. Because the braid1810is embolic, as blood travels through the extended length of the columnar braid segment1852, the braid segment can become clogged with thrombotic material to thereby promote venous stasis within the aneurysm10. The middle segment1844can include bends1832,1834of approximately 90° to cause a distal section1856of the middle segment1844to press into the aneurysm walls14and to cause the diameter D3of the neck opening1826to collapse to a smaller neck opening1826awhen implanted. The braid1810can include an approximately 90° bend approximate the proximal inversion1822(in the predetermined shape) to cause the braid1810near the proximal inversion1822a(when implanted) to be substantially parallel to the neck plane18(FIG. 6B) and to also cause the diameter D3of the neck opening1826to collapse to a smaller neck opening1826awhen implanted. The implanted shape includes inversions1822a,1824aand layers1842a,1844a,1846arespectively corresponding to inversions1822,1824and segments1842,1844,1846of the predetermined shape.

FIG. 36Aillustrates an implant1900having a predetermined shape similar to that illustrated inFIG. 35Awith an exception that the height H4of the neck opening1926is comparatively foreshortened. The foreshortened height H4of the neck opening1926can cause the diameter D3of the neck opening1926awhen implanted to be decreased smaller than the diameter of the neck opening1826aof the implant1800illustrated inFIG. 35B, all other factors being equal.

The middle segment1944can include bends1932,1934of approximately 90° to cause a distal section1956of the middle segment1944to press into the aneurysm walls14and to cause the diameter D3of the neck opening1926to collapse to a smaller neck opening1926awhen implanted. The braid1910can include an approximately 90° bend approximate the proximal inversion1922(in the predetermined shape) to cause the braid1910near the proximal inversion1922a(when implanted) to be substantially parallel to the neck plane18(FIG. 6B) and to also cause the diameter D3of the neck opening1826to collapse to a smaller neck opening1826awhen implanted. The implanted shape includes inversions1922a,1924aand layers1942a,1944a,1946arespectively corresponding to inversions1922,1924and segments1942,1944,1946of the predetermined shape.

The predetermined shapes illustrated inFIGS. 35A and 36Ahave an outer profile that approximates a right cylinder. The respective braids1810,1910can respectively have a proximal bend1836,1936of approximately 90° near the proximal inversion1822,1922. The respective braids1810,1910are illustrated as having an acute angle near the respective distal inversions1824,1924. Alternatively, the respective braids1810,1910can include a distal bend approximately 90° near distal inversions1824,1924, shaped similarly to the respective proximal bends1836,1936.

FIG. 37Aillustrates an implant2000having a foreshortened height H4of the neck opening2026similar to that illustrated inFIG. 36A.FIG. 37Aillustrates a braid2010having a pear or teardrop shaped profile. Alternatively, the braid2010can have a profile that approximates a sphere or some shape between the pear as illustrated and a sphere. Compared to the shapes illustrated inFIGS. 35A and 36A, the pear or teardrop shaped profile can provide an increased outward force against aneurysm walls14in the proximal portion of the aneurysm sac12(i.e. near the neck16) and decreased outward force in the dome of the aneurysm sac12(i.e. near the distal wall15). Increased outward force in the proximal portion can increase impaction resistance of the implant2000. Reduced force at the dome can reduce risk of rupturing a fragile dome by the implant2000.

The middle segment2044includes a bend2034separating a columnar segment2052from a sack-shaped segment2054. Configured as such, the diameter D3of the neck opening2026can collapse to a smaller neck opening2026awhen implanted. The implanted shape includes inversions2022a,2024aand layers2042a,2044a,2046arespectively corresponding to inversions2022,2024and segments2042,2044,2046of the predetermined shape. The middle layer2044acan be positioned in closer proximity to the aneurysm neck16compared to some of the other example braids illustrated herein, including the implants100,1800,1900illustrated inFIGS. 1B, 35B, and 36B. Increased density of braid material at the aneurysm neck16can further inhibit blood flow into the aneurysm sac12and thereby promote venous stasis. The closer proximity of the middle layer2044ato the aneurysm neck can further allow for the braid2010to more easily invert because there is less material that needs to be deployed out of the catheter600in order to perform the inversion step to invert the braid2010into itself.

Various features of the example implants, systems, and methods illustrated and described herein are combinable as understood by a person skilled in the pertinent art according to teachings herein. Not every combinable feature is expressly illustrated or stated for the sake of brevity.

Implants100,200,300,400,500,700,800,900,1000,1300,1600,1600a,1800,1900,2000can include a combination of round and flattened wires according to the principles illustrated and described in relation toFIGS. 15A-Cand16A-C.

The tubular braid110,210,310,410,510,560,710,760,810,860,910,1010,1310,1610,1810,1910,2010of the example implants100,200,300,400,500,700,800,900,1000,1300,1600,1600a,1800,1900,2000can include memory shape material that can be heat set to a predetermined shape, can be deformed for delivery through a catheter, and can self-expand to an implanted shape that is based on the predetermined shape and confined by the anatomy of the aneurysm in which it is implanted. Tubular braid can further include platinum wire strands, markers, or other radiopaque features.

The example implants100,200,300,400,500,700,800,900,1000,1300,1600,1600a,1800,1900,2000can rely on a radial outward force to anchor the implant within the sac of an aneurysm. To this end, the braid(s)110,210,310,410,510,560,710,760,810,860,910,1010,1310,1610,1810,1910,2010can be shaped to a predetermined shape having a diameter (diameter of outermost braid, radially, for implants having multiple braid layers) that is greater than its height (between distal most layer and proximal most layer for implants having multiple braid layers) so that the braid is radially constricted when implanted in an aneurysm. The ratio of diameter to height of the braid(s) in a respective predetermined shape can be within the range of 2:1 to 1:3 to treat aneurysms of many known sizes and shapes.

The descriptions contained herein are examples of embodiments of the invention and are not intended in any way to limit the scope of the invention. As described herein, the invention contemplates many variations and modifications of the implant, including alternative materials, alternative geometries, alternative detachment features, alternative delivery systems, alternative means for forming a braid into a predetermined shape, alternative treatment methods, alternative number of braid layers, etc. These modifications apparent to those having ordinary skill in the art to which this invention relates are intended to be within the scope of the claims which follow.