US 20170156733A1

(19) United States

(12) Patent Application Publication (10) Pub. No.: US 2017/0156733 A1
Becking et al. (43) Pub. Date: Jun. 8, 2017
(54) MULTIPLE LAYER FLAMENYARY filed on Apr. 21, 2008, provisional application No.
DEVICES FOR TREATMENT OF VASCULAR 61/083,957, filed on Jul. 28, 2008, provisional appli
DEFECTS cation No. 61/083,961, filed on Jul. 28, 2008, provi
sional application No. 61/145,097, filed on Jan. 15,
(71) Applicant: Covidien LP, Mansfield, MA (US) 2009.

(72) Inventors: Frank P. Becking, Palo Alto, CA (US); Publication Classification

Arturo S. Rosqueta, San Jose, CA (51) Int. Cl.
(US); Siddharth Loganathan, Santa A6B 7/2 (2006.01)
Clara, CA (US) (52) U.S. Cl.
(21) Appl. No.: 15/415,669 CPC. A61B 17/12159 (2013.01); A61B 17/12031
(2013.01); A61B 17/12113 (2013.01); A61B
(22) Filed: Jan. 25, 2017 17/12172 (2013.01); A61B 2017/00526
(2013.01)
Related U.S. Application Data (57) ABSTRACT
(63) Continuation of application No. 13/470.013, filed on Braid-balls suitable for aneurysm occlusion and/or parent
May 11, 2012, now Pat. No. 9,585,669, which is a vessel occlusion/sacrifice (e.g., in treating neurovascular
continuation of application No. 12/911,034, filed on defects) are disclosed. Especially for aneurysm treatment,
Oct. 25, 2010, now Pat. No. 9,039,726, which is a but also for either one of the aforementioned treatments, the
continuation of application No. 12/427,620, filed on form of the ball is very important. In particular, the density
Apr. 21, 2009, now Pat. No. 8,142,456. of the device is paramount in applications where braid itself
(60) Provisional application No. 61/046,594, filed on Apr. is intended to moderate or stop blood flow—allowing throm
21, 2008, provisional application No. 61/046,670, bosis within a volume formed by the ball.
Patent Application Publication Jun. 8, 2017. Sheet 1 of 2 US 2017/0156733 A1
Patent Application Publication Jun. 8, 2017. Sheet 2 of 2 US 2017/O156733 A1

50
O

52
US 2017/O156733 A1 Jun. 8, 2017

MULTIPLE LAYER FLAMENYARY wraps or bands (preferably Pt) used to secure the braid wire
DEVICES FOR TREATMENT OF VASCULAR may serve as the sole radiopaque feature(s).
DEFECTS 0009. In any case, the construction approaches described
herein enable producing these useful devices. Whether com
CROSS REFERENCE TO RELATED prising braid alone, or incorporating some further blood
APPLICATIONS barrier covering (such as a thin urethane film as may be
0001. This filing is a continuation of U.S. patent appli applied by Hantel, Inc. or others) the use of braid presents
cation Ser. No. 12/911,034, filed Oct. 25, 2010, which is a numerous challenges in managing the termination of mul
continuation of U.S. patent application Ser. No. 12/427,620 tiple wires and in forming the desired structures.
filed Apr. 21, 2009 which claims the benefit of each of U.S. 0010. Also included in the invention are detachable
Patent Application Ser. Nos. 61/046,594 and 61/046,670, implant pushers that utilize a resistance wire heater to
both filed Apr. 21, 2008; U.S. Patent Application Ser. Nos. thermally sever a suture associated with the implant to effect
61/083,957 and 61/083,961, both filed Jul. 28, 2008; and release. As distinguished from known approaches where an
U.S. Patent Application Ser. No. 61/145,097, filed Jan. 15, implant is retained by a loop connected back to a delivery
2009. Each of the foregoing applications is incorporated system pusher that is withdrawn with the devilry system, the
herein by reference in its entirety. present invention contemplates a leave-behind tether.
0011. Further details, variations, modification and
FIELD OF THE INVENTION optional features of the invention may be appreciated by
review of any of the incorporated patent applications. How
0002 The present invention is directed to braid-balls ever, the priority date and subject matter included in the
Suitable for aneurysm occlusion and/or parent vessel occlu appended claims rely solely on the subject matter filed in
sion/sacrifice (e.g., in treating neurovascular defects). U.S. Provisional Patent Application Nos. 61/046670 and
61/046594, the earliest patent applications (each filed Apr.
BACKGROUND 21, 2008) one which U.S. patent application Ser. No. 12/427,
620 relies. Selected figures from the 670 and 594 appli
0003) Especially for aneurysm treatment, but also for cation and all of text from the 594 application—all—
either one of the aforementioned treatments, the form of the incorporated by reference in the parent application hereto is
ball is very important. In particular, the density of the device reproduced herein.
is paramount in applications where braid itself is intended to
moderate or stop blood flow—allowing thrombosis within a BRIEF DESCRIPTION OF THE DRAWINGS
volume formed by the ball.
0004. According to the present invention, braid-ball type 0012 FIG. 1 is a photograph taken from U.S. Provisional
implants are provided in braid of sufficient density is pro Patent Appl. No. 61/046,670 (incorporated herein by refer
vided to moderate blood flow within the volume of the ence) demonstrating actual reduction to practice of a single
implant. Upon thrombosis, flow thereto is stopped. Alterna layer braid ball device made according to the present inven
tively, a blood-barrier covering can be applied to the fila tion;
mentary structure to immediately stop blood flow into the 0013 FIGS. 2A and 2B are side-sectional views of the
vascular site, in which the implant Volume is set. braid ball in isolation and in use, respectively;
0005. In either case, to form thrombosis within the vol 0014 FIG. 3 illustrates a suture-melt resistance heater
ume of the ball, the filaments of the braid matrix permit pusher for implant delivery; and
filling of the implant with blood when emplaced at a 0015 FIGS. 4A-4F illustrate a production path of one
vascular treatment site. This blood then thromboses due to implant embodiment encompassed by the current invention.
the flow-disruption effect(s). DETAILED DESCRIPTION OF THE
0006 Unlike Nitinol tube-cut cages that may be suitable INVENTION
for (or assist) in coil retention, the ball devices are adapted
to work alone—or in combination with each other to effect (0016. Implants
a complete treatment. As such, high density braid/mesh is 0017 Referring to the figures, a filamentary implant 2 is
typically required. Namely, braid having at least about 48 formed out of braid to treat vascular sites. Interwoven
ends, typically set at about 90 degrees or greater, in diam filaments 4 form a braid matrix 6 that define a self-expand
eters from about 4 to about 8 mm may be employed. At able occlusion device.
larger diameters (e.g., about 6 to 12 or more), more wire 0018. As single layer of the braid is provided in which
ends (e.g., 64.72 and upwards) may be employed in forming ends of the braid are secured and managed to provide an
the balls. atraumatic interface. Specifically, ties 10 (as illustrated in
0007 Suitable braid for constructing the balls may be FIG. 1) or bands 12 (as illustrated in FIG. 2A and 2B) secure
obtained from Secant Medical, Inc. Wire diameters may be filament the ends 14 of the braid from which the implant is
in the range of about 0.001 to about 0.003 inches, depending constructed.
on desired delivery profile (which is typically less than about 0019. In the implant variation pictured, the expanded
0.050 inches). The braid forming the balls may incorporate configuration defines an ovoid or roughly spherical shell 18
only one size wire, or may be formed with multiple sizes. that is permeable to blood. The braid defining the proximal
0008. The wire is preferably superelastic NiTi alloy. The and distal ends of the implant turns or curves inward to a
metal may be a binary alloy or a ternary alloy to provide point where it is secured within the periphery of the shell.
additional radiopacity. Alternatively, radiopaque platinum 0020. The inversion of the braid provides recessed
fibers may be included in the braid, or the wire may securement of the braid resulting in atraumatic ends of the
comprise platinum or gold cord Nitinol DFT. Otherwise, implant. The braid filaments optionally extend beyond the
US 2017/O156733 A1 Jun. 8, 2017

securing/securement features in order to define wire filament 0027 Methods of Use

"tufts' 20 that will further promote thrombosis of blood that 0028. Any one of the subject implants is delivered to a
enters the ball upon deployment within a patient’s vascula target site employing known percutaneous catheter access
ture. However configured in regard to braid filament end techniques. The implant may be secured to a pusher (e.g.,
securement and termination, inset ends of the braid (proxi pusher 30) used to advance it through the access catheter
mal and distal insets 22/24, respectively) are demonstrated (e.g., microcatheter 44). Upon emplacement at the treatment
when the implant is in an expanded State to fill an aneurysm site (e.g., cerebral aneurysm 26 as illustrated in FIG. 2A),
26 off of a vessel 28. the implant can be detached. With the exemplary system
0021 Delivery Systems shown in FIG. 3, the suture 40 passing through the proximal
0022 FIG. 3 illustrates a detachable catheter/pusher 30, end of the implant 2 is severed by melting it using a
optionally, for use in the present invention. Generally, it resistance heater. This retention/release fiber remains in and
includes a resistance wire bridge 32 across insulated con with the implant.
ductors 34 (a typical construction). What is unique is that the 1-79. (canceled)
conductor wires are twinned/twisted along a length of the 80. An embolic device comprising:
delivery pusher shaft 38 as shown. This configuration alle a braid forming inner and outer layers and configured to
viates bending bias/preference. Upon application of Voltage, compress for delivery through a catheter and expand
the tip thermally severs the polymer filament (e.g., Suture upon release from the constraint of the catheter to
40) in contact therewith. At least the suture portion is define an open Volume, wherein the inner and outer
received within the implant 2 (e.g., passing through a layers meet at a folded section that is closed to define
braid-securing band 12). The suture is retained in/with the a distal end of the device, and wherein the inner and
implant upon actuation to release the implant by cutting outer layers further meet at a hub that closes and holds
through the suture with heat. A ball stop 42 that is tied to the at least the outer braid layer at the proximal end of the
suture retains the filament in/with the implant is also illus device.
trated. Finally, pusher 30 is shown received within a typical 81. The device of claim 80 wherein portions of the device
microcatheter 44 for vascular access, after passage there adjacent to the hub and to the folded section are rounded
though. Note also, other advantageous delivery system are when fully expanded.
referenced and described in the incorporated patent appli 82. The device of claim 80 wherein the braid has a flared
cation. profile when expanded.
0023 Methods of Manufacture 83. The device of claim 80 wherein the braid is ball
0024. Included in the intention is a method of manufac shaped when expanded.
ture including tying-off or otherwise securing a second end 84. The device of claim 80 wherein the inner and outer
of a braid within an interior volume of a ball where other layers at the folded section together define a dome-shaped
approaches would be impracticable. The technique may be atraumatic Surface when expanded.
employed in creating the balls (be they spherical or ovaloid 85. The device of claim 80 wherein the inner braid layer
in cross-section, etc.) out of one continuous section of braid. is not held in the hub.
In so doing, joints and other delivery profile-increasing 86. The device of claim 80 wherein both the inner and
features are avoided—as well as potential areas for failure. outer braid layers are held in the hub.
Accordingly, the Subject implants are extremely robust and 87. The device of claim 80 wherein the hub comprises an
fully recoverable to their aneurysmal shape as is required outer band and an inner band, wherein the braid is between
when they are delivered through a catheter in low profile. the outer band and the inner band and the inner band defines
Robust shape recovery is required in treatments targeting a hub port configured to receive an elongated delivery
distal vasculature, especially the tortuous neurovasculature member.
encountered in human brains. 88. The device of claim 80 wherein the hub is radiopaque.
0025. A detailed example of one process path for implant 89. The device of claim 80 wherein the braid is one of a
formation is illustrated in FIGS. 4A-4F. As shown in FIG. 4F 64-wire braid, a 72-wire braid, a 96-wire braid, a 128-wire
an final implant 2 may begin as a section 50 of braided braid, or a 144-wire braid.
material. The tubular braid stock is secured. As shown, it is 90. The device of claim 80 wherein the braid comprises a
tied-off with a wire wrap 10. Such action develops an inset plurality of wires, and wherein at least some of the wires are
region 24 for the implant body. An opposite end of the braid platinum core Nitinol DFT or gold core Nitinol DFT.
is then captured in a transfer tube 52. The tube is passed 91. The device of claim 80 wherein the braid comprises a
through the Volume of the implant and secured with a second plurality of wires, and wherein at least some of the wires are
tie 10 at the other side. a Superelastic alloy.
0026. Additional refinement to the shape over that shown 92. An embolic device comprising:
in FIG. 4E may be imparted within a shape-setting form 54. a mesh formed of an inverted tubular braid that has been
Mandrels 56 including stops 58 received through the secure heat set to form a predetermined, three-dimensional
ment features may be employed to force apposition of the shape in an expanded configuration, the braid compris
ball to the shape of the form when pulled apart as indicated ing a plurality of wires having first and second ends,
by arrows. After shape-setting in the form (as appropriate to wherein a distal end of the mesh has a folded section
the selected material—e.g., as in heat setting Superelastic and defines a dome-shaped atraumatic Surface when the
Nitinol) the mandrels are removed and the implant shaping mesh is expanded, and wherein the first and second
is complete as shown in FIG. 4F. However, these additional ends of the braid are held together by a hub at a
forming steps are not necessary given that (in point of fact) proximal end of the device.
the implant in FIG. 1 was produced without employing the 93. The device of claim 92 wherein the three-dimensional
SaC. shape is generally spherical.
US 2017/O156733 A1 Jun. 8, 2017

94. The device of claim 92 wherein the hub comprises an

outer band and an inner band, wherein the braid is between
the outer band and the inner band and the inner band defines
a hub port configured to receive an elongated delivery
member.
95. The device of claim 92 wherein the hub is radiopaque.
96. The device of claim 92 wherein the braid is one of a
64-wire braid, a 72-wire braid, a 96-wire braid, a 128-wire
braid, or a 144-wire braid.
97. The device of claim 92 wherein at least Some of the
wires of the braid are platinum core Nitinol DFT or gold core
Nitino DFT.
98. The device of claim 92 wherein at least some of the
wires of the braid are a superelastic alloy.
99. The device of claim 92 wherein the mesh includes an
inner braid layer and an outer braid layer, and wherein the
inner braid layer and the outer braid layer are continuous at
the folded section.