U.S. patent application number 13/802225 was filed with the patent office on 2014-09-18 for braided flow diverter using flat-round technology.
This patent application is currently assigned to DePuy Synthes Products, LLC. The applicant listed for this patent is DEPUY SYNTHES PRODUCTS, LLC. Invention is credited to Juan A. Lorenzo, Robert Slazas.
Application Number | 20140277386 13/802225 |
Document ID | / |
Family ID | 50280156 |
Filed Date | 2014-09-18 |
United States Patent
Application |
20140277386 |
Kind Code |
A1 |
Slazas; Robert ; et
al. |
September 18, 2014 |
BRAIDED FLOW DIVERTER USING FLAT-ROUND TECHNOLOGY
Abstract
A generally tubular braided flow diverting stent is formed of
alternating round and rectangular elongated members, for treatment
of aneurysms. The generally tubular braided flow diverting stent
maintains a significant wall thickness while increasing area
coverage of a vessel wall. Sliding of the round elongated members
over the rectangular elongated members allows the stent to be
crimped to very low diameters for delivery in narrow portions of
the vasculature.
Inventors: |
Slazas; Robert; (Pinecrest,
FL) ; Lorenzo; Juan A.; (Davie, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
DEPUY SYNTHES PRODUCTS, LLC |
Raynham |
MA |
US |
|
|
Assignee: |
DePuy Synthes Products, LLC
Raynham
MA
|
Family ID: |
50280156 |
Appl. No.: |
13/802225 |
Filed: |
March 13, 2013 |
Current U.S.
Class: |
623/1.22 |
Current CPC
Class: |
A61F 2/88 20130101; A61F
2002/823 20130101; A61B 2090/3966 20160201; D10B 2509/06 20130101;
A61B 90/39 20160201; A61F 2230/0008 20130101; A61F 2/885 20130101;
A61F 2250/0036 20130101; A61F 2/90 20130101; D04C 1/06 20130101;
A61F 2230/0019 20130101; A61F 2230/0006 20130101; A61F 2250/0028
20130101 |
Class at
Publication: |
623/1.22 |
International
Class: |
A61F 2/88 20060101
A61F002/88 |
Claims
1. A generally tubular braided flow diverting stent for treatment
of aneurysms, comprising: at least one first elongate member
helically wound in a first helical direction in a generally tubular
shape, said at least one first elongate member having a
substantially round cross-sectional shape; and at least one second
elongate member helically wound in a second helical direction
counter to said first helical direction and braided with said at
least one first elongate member in said generally tubular shape,
said at least one second elongate member having a substantially
flat radially outer surface.
2. The generally tubular braided flow diverting stent of claim 1,
wherein said at least one first elongate member has a substantially
circular cross-sectional shape.
3. The generally tubular braided flow diverting stent of claim 1,
wherein said at least one first elongate member comprises a
plurality of first elongate members.
4. The generally tubular braided flow diverting stent of claim 1,
wherein said at least one first elongate member comprises a
plurality of first wires.
5. The generally tubular braided flow diverting stent of claim 1,
wherein said at least one second elongate member has a
cross-sectional thickness in a first direction and a
cross-sectional thickness in a second direction perpendicular to
said first direction substantially greater than said
cross-sectional thickness in said first direction.
6. The generally tubular braided flow diverting stent of claim 1,
wherein said at least one second elongate member has a rectangular
cross-sectional shape.
7. The generally tubular braided flow diverting stent of claim 1,
wherein said at least one second elongate member comprises a
plurality of second elongate members.
8. The generally tubular braided flow diverting stent of claim 1,
wherein said at least one second elongate member comprises a
plurality of second wires.
9. The generally tubular braided flow diverting stent of claim 1,
wherein said at least one first elongate member is formed of a
material selected from the group consisting of stainless steel,
nickel-titanium alloy, tantalum, cobalt-chromium alloy, platinum,
and combinations thereof.
10. The generally tubular braided flow diverting stent of claim 1,
wherein said at least one first elongate member is formed of a
bioabsorbable material selected from the group consisting of
poly(D,L-lactic acid-co-glycolic acid), polycaprolactone,
magnesium, and combinations thereof.
11. The generally tubular braided flow diverting stent of claim 1,
wherein said at least one second elongate member is formed of a
material selected from the group consisting of stainless steel,
nickel-titanium alloy, tantalum, cobalt-chromium alloy, platinum,
and combinations thereof.
12. The generally tubular braided flow diverting stent of claim 1,
wherein said at least one second elongate member is formed of a
bioabsorbable material selected from the group consisting of
poly(D,L-lactic acid-co-glycolic acid), polycaprolactone,
magnesium, and combinations thereof.
13. The generally tubular braided flow diverting stent of claim 3,
wherein at least a portion of said plurality of first elongate
members comprises a bioabsorbable material.
14. The generally tubular braided flow diverting stent of claim 7,
wherein at least a portion of said plurality of second elongate
members comprises a bioabsorbable material.
15. The generally tubular braided flow diverting stent of claim 1,
wherein said at least one first elongate member is formed of a
radio-opaque material.
16. The generally tubular braided flow diverting stent of claim 1,
wherein said at least one second elongate member is formed of a
radio-opaque material.
17. A generally tubular braided flow diverting stent for treatment
of aneurysms, comprising: a plurality of first elongate members
helically wound in a first helical direction in a generally tubular
shape, said plurality of first elongate members having a
substantially round cross-sectional shape; a plurality of second
elongate members helically wound in said first helical direction in
said generally tubular shape alternatingly between said plurality
of first elongate members, respectively, said plurality of second
elongate members having a substantially flat radially outer
surface; a plurality of third elongate members helically wound in a
second helical direction counter to said first helical direction
and braided with said plurality of first elongate members and said
plurality of second elongate members in said generally tubular
shape, said plurality of third elongate members having a
substantially round cross-sectional shape; and a plurality of
fourth elongate members helically wound in a second helical
direction counter to said first helical direction and braided with
said plurality of first elongate members and said plurality of
second elongate members in said generally tubular shape
alternatingly between said plurality of third elongate members,
said plurality of fourth elongate members having a substantially
flat radially outer surface.
18. The generally tubular braided flow diverting stent of claim 17,
wherein said plurality of first elongate members and said plurality
of third elongate members each have a substantially circular
cross-sectional shape.
19. The generally tubular braided flow diverting stent of claim 17,
wherein said plurality of second elongate members and said
plurality of fourth elongate members each have a cross-sectional
thickness in a first direction and a cross-sectional thickness in a
second direction perpendicular to said first direction
substantially greater than said cross-sectional thickness in said
first direction.
20. The generally tubular braided flow diverting stent of claim 17,
wherein said plurality of second elongate members and said
plurality of fourth elongate members each have a rectangular
cross-sectional shape.
21. The generally tubular braided flow diverting stent of claim 17,
wherein said pluralities of first, second, third and fourth
elongate members are formed of a material selected from the group
consisting of stainless steel, nickel-titanium alloy, tantalum,
cobalt-chromium alloy, platinum, and combinations thereof.
22. The generally tubular braided flow diverting stent of claim 17,
wherein at least a portion of said pluralities of first, second,
third and fourth elongate members are formed of a bioabsorbable
material selected from the group consisting of poly(D,L-lactic
acid-co-glycolic acid), polycaprolactone, magnesium, and
combinations thereof.
23. The generally tubular braided flow diverting stent of claim 17,
wherein at least a portion of said pluralities of first, second,
third and fourth elongate members are formed of a radio-opaque
material.
Description
BACKGROUND OF THE INVENTION
[0001] This invention relates generally to a vascular implant that
can be used for treatment of aneurysms, and more particularly
concerns a braided flow diverter using flat-round technology to
divert flow away from an entrance or neck of an intracranial
aneurysm or to define a new luminal flow path through a fusiform
aneurysm, as an alternative or supplement to delivery of an embolic
coil within such an aneurysm.
[0002] Braided stents are typically formed from a plurality of
elongate members, such as two or more metal wires, or polymeric
fibers or strands of material, for example, and can be very useful
in treatment of neurovascular defects. Braided flow diverting
stents are commonly constructed from round wires. While the use of
round wires in forming such braided flow diverting stents typically
provide a maximal wall-thickness for their construction, the amount
of vessel area coverage provided by such braided flow diverting
stents is not maximized. Braided stents constructed of all
rectangular cross-section wires can maximize vessel wall area
coverage, but minimize wall thickness. Braided stents made of all
rectangular cross-section wires also typically have a more limiting
minimum crimped diameter for delivery than a comparable braided
flow diverting stent constructed from round wires, since
rectangular cross-section wires typically slide less easily past
each other than comparable round wires.
[0003] It would be desirable to provide a braided flow diverting
stent with an improved overall combination of axial flow disruption
characteristics, wall coverage and wall thickness, compared to a
braided flow diverting stent formed of all rectangular
cross-section wires or formed of all round wires. It also would be
desirable to provide a braided flow diverting stent that can be
crimped to minimum crimped diameters for delivery, comparable to
that achievable with braided flow diverting stents constructed from
round wires. The present invention meets these and other needs.
SUMMARY OF THE INVENTION
[0004] Briefly and in general terms, the present invention provides
for a generally tubular braided flow diverting stent formed of
alternating round and rectangular elongated members, for treatment
of aneurysms. The generally tubular braided flow diverting stent
can be utilized to redirect blood flow away from a neck of an
intracranial aneurysm, or to define a new luminal flow path through
a fusiform aneurysm. The generally tubular braided flow diverting
stent maintains a significant wall thickness while increasing area
coverage of a vessel wall. The sliding of round elongated members
over rectangular elongated members also provides very low crimped
diameters to allow delivery of the braided flow diverting stent in
narrow portions of the vasculature. Total wall thickness is reduced
compared to a braided stent having a similar vessel wall coverage
using only round wires. Axial flow disruption is improved compared
to a braid of similar vessel wall coverage using only flat
wires.
[0005] The present invention accordingly provides for a generally
tubular braided flow diverting stent for treatment of aneurysms,
including one or more first elongate members having a substantially
round cross-sectional shape and helically wound in a first helical
direction in a generally tubular shape, and one or more second
elongate members having a substantially flat radially outer surface
and helically wound in a second helical direction counter to the
first helical direction and braided with the one or more first
elongate members in the generally tubular shape. In a presently
preferred aspect, the one or more first elongate members have a
substantially circular cross-sectional shape. In another presently
preferred aspect, the one or more second elongate members have a
cross-sectional thickness in a first direction and a
cross-sectional thickness in a second direction perpendicular to
the first direction that is substantially greater than the
cross-sectional thickness in the first direction. In another
presently preferred aspect, the one or more second elongate members
have a rectangular cross-sectional shape. In another presently
preferred aspect, a plurality of first elongate members are
provided, such as a plurality of first wires, for example, and a
plurality of second elongate members are provided, such as a
plurality of second wires.
[0006] In another presently preferred aspect, the one or more first
elongate members and the one or more second elongate members may be
formed of a material such as stainless steel, nickel-titanium
alloy, tantalum, cobalt-chromium alloy, platinum, or combinations
thereof. In another presently preferred aspect, at least a portion
of the plurality of first elongate members is formed of a
bioabsorbable material. In another presently preferred aspect, at
least a portion of the plurality of second elongate members
comprises a bioabsorbable material. In another presently preferred
aspect, at least a portion of the one or more first elongate
members and the one or more second elongate members may be formed
of a bioabsorbable material such as poly(D,L-lactic
acid-co-glycolic acid), polycaprolactone, magnesium, or
combinations thereof. In another presently preferred aspect, some
of the first and second elongate members optionally may be made of
a radio-opaque material to facilitate guidance under imaging
methods like fluoroscopy.
[0007] In another embodiment, the present invention provides for a
generally tubular braided flow diverting stent for treatment of
aneurysms, including a plurality of first elongate members having a
substantially round cross-sectional shape and helically wound in a
first helical direction in a generally tubular shape, a plurality
of second elongate members having a substantially flat radially
outer surface and helically wound in the first helical direction in
the generally tubular shape alternatingly between the plurality of
first elongate members, respectively, a plurality of third elongate
members having a substantially round cross-sectional shape and
helically wound in a second helical direction counter to the first
helical direction and braided with the plurality of first elongate
members and the plurality of second elongate members in the
generally tubular shape, and a plurality of fourth elongate members
having a substantially flat radially outer surface and helically
wound in a second helical direction counter to the first helical
direction and braided with the plurality of first elongate members
and the plurality of second elongate members in the generally
tubular shape alternatingly between the plurality of third elongate
members.
[0008] In a presently preferred aspect, the plurality of first
elongate members and the plurality of third elongate members each
have a substantially circular cross-sectional shape. In another
presently preferred aspect, the plurality of second elongate
members and the plurality of fourth elongate members each have a
cross-sectional thickness in a first direction and a
cross-sectional thickness in a second direction perpendicular to
the first direction substantially greater than the cross-sectional
thickness in the first direction. In another presently preferred
aspect, the plurality of second elongate members and the plurality
of fourth elongate members each have a rectangular cross-sectional
shape.
[0009] In another presently preferred aspect, the pluralities of
first, second, third and fourth elongate members may be formed of
stainless steel, nickel-titanium alloy, tantalum, cobalt-chromium
alloy, platinum, or combinations thereof. In another presently
preferred aspect, at least a portion of the pluralities of first,
second, third and fourth elongate members may be formed of a
bioabsorbable material selected from the group consisting of
poly(D,L-lactic acid-co-glycolic acid), polycaprolactone,
magnesium, or combinations thereof. In another presently preferred
aspect, some of the first, second, third and fourth elongate
members optionally may be made of a radio-opaque material to
facilitate guidance under imaging methods like fluoroscopy.
[0010] Other features and advantages of the present invention will
become more apparent from the following detailed description of the
preferred embodiments in conjunction with the accompanying
drawings, which illustrate, by way of example, the operation of the
invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a cross-sectional elevational schematic diagram of
a first embodiment of a braided flow diverting stent according to
the invention.
[0012] FIG. 2 is a cross-sectional elevational schematic diagram of
a second embodiment of a braided flow diverting stent according to
the invention.
[0013] FIG. 3 is a cross-sectional view taken along line 3-3 of
FIG. 1.
[0014] FIG. 4 is a cross-sectional view taken along line 4-4 of
FIG. 1.
[0015] FIG. 5 is a cross-sectional view taken along line 5-5 of
FIG. 1.
[0016] FIG. 6 is a cross-sectional view similar to FIG. 5 of an
exemplary braided flow diverting stent constructed substantially
only from round wires for purposes of comparison.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0017] Referring to the drawings, which are provided by way of
example, and not by way of limitation, in a first embodiment,
illustrated in FIG. 1, the present invention provides for a
generally tubular braided flow diverting stent 10 for treatment of
aneurysms, having a proximal end 12, a distal end 14, and an inner
lumen (not shown). The generally tubular braided flow diverting
stent is preferably formed from a plurality of elongate members, is
typically formed from two or more metal wires, or polymeric fibers
or strands of material, for example. In a presently preferred
aspect, the tubular braided stent optionally may be a
self-expanding stent, formed to have a compressed configuration and
an expanded configuration. In another presently preferred aspect,
the tubular braided stent optionally may be formed of a shape
memory material such as a nickel-titanium alloy, for example,
having a shape memory position in the expanded configuration. For
example, the tubular braided stent may be appropriately heat
treated so that the tubular braided stent forms in the desired
shape of the expanded shape memory position.
[0018] The generally tubular braided flow diverting stent includes
one or more first elongate members 18 helically wound in a first
helical direction in a generally tubular shape, and one or more
second elongate members 20, helically wound in a second helical
direction counter to the first helical direction and braided with
the one or more first elongate members in the generally tubular
shape.
[0019] Referring to FIG. 4, the one or more first elongate members
preferably have a substantially round cross-sectional shape, such
as a substantially circular cross-sectional shape, for example,
although the one or more first elongate members may optionally have
a substantially oval cross-sectional shape. The one or more first
elongate members preferably also are formed of a plurality of first
elongate members, such as a plurality of first wires, for example.
As is illustrated in FIG. 1, the generally tubular braided flow
diverting stent can be formed with round wires wound helically in a
right handed helical direction, and rectangular wires wound
helically in a left handed helical direction.
[0020] Referring to FIG. 3, the one or more second elongate members
preferably have a substantially flat radially outer surface. In
another presently preferred aspect, the one or more second elongate
members typically have a cross-sectional height or thickness H in a
first direction and a cross-sectional width or thickness W in a
second direction perpendicular to the first direction substantially
greater than the cross-sectional height or thickness in the first
direction, and typically have a generally rectangular or flattened
aspect, for example. The one or more second elongate members
preferably also are formed of a plurality of second elongate
members, such as a plurality of second wires, for example. The one
or more first elongate members and the one or more second elongate
members are preferably formed of a material such as stainless
steel, nickel-titanium alloy, tantalum, cobalt-chromium alloy,
platinum, or the like, or of a polymer, such as a shape memory
polymer, or a bioabsorbable material such as poly(D,L-lactic
acid-co-glycolic acid) (PGLA), polycaprolactone (PCL), or the like,
or combinations thereof. In a presently preferred aspect, some or
all of the elongated members used are composed of a bioabsorbable
material. In another presently preferred aspect, some or all of the
elongate members optionally may be made of a radio-opaque material
to facilitate guidance under imaging methods like fluoroscopy.
[0021] Referring to FIGS. 5 and 6, the total wall thickness of a
generally tubular braided flow diverting stent according to the
invention formed utilizing one or more first elongate members
having a substantially round cross-sectional shape, and one or more
second elongate members having a substantially flat radially outer
surface, illustrated in FIG. 5, is reduced compared to a buildup of
thickness of the wall of a generally tubular braided flow diverting
stent, having a similar vessel wall coverage and formed of all
round wires, illustrated in FIG. 6.
[0022] In the method of making the generally tubular braided flow
diverting stent of the first embodiment, a braider machine can be
loaded with bobbins of round wire in all right handed helical
locations, and rectangular wire in all left handed helical
locations. Conversely, a braider machine can be loaded with bobbins
of round wire in all left handed helical locations, and rectangular
wire in all right handed helical locations, for example.
[0023] In a second embodiment, illustrated in FIG. 2, in which like
elements are indicated by like reference numbers, the present
invention provides for a generally tubular braided flow diverting
stent 30 for treatment of aneurysms. The tubular braided flow
diverting stent has a proximal end 32, a distal end 34, and an
inner lumen (not shown), and is preferably formed from a plurality
of elongate members, typically formed from two or more metal wires,
or polymeric fibers or strands of material, for example. In one
presently preferred aspect, the tubular braided stent optionally
may be a self-expanding stent, formed to have a compressed
configuration and an expanded configuration. The tubular braided
flow diverting stent can be formed of a shape memory material such
as a nickel-titanium alloy, for example, having a shape memory
position in the expanded configuration. For example, the tubular
braided flow diverting stent may be appropriately heat treated so
that the tubular braided flow diverting stent forms in the desired
shape of the expanded shape memory position.
[0024] The generally tubular braided flow diverting stent of the
second embodiment preferably includes a plurality of first elongate
members 38 helically wound in a first helical direction in a
generally tubular shape, a plurality of second elongate members 40
helically wound in the first helical direction in the generally
tubular shape alternatingly between the plurality of first elongate
members, a plurality of third elongate members 42 helically wound
in a second helical direction counter to the first helical
direction and braided with the plurality of first elongate members
and the plurality of second elongate members in the generally
tubular shape, and a plurality of fourth elongate members 44
helically wound in a second helical direction counter to the first
helical direction and braided with the plurality of first elongate
members and the plurality of second elongate members in the
generally tubular shape alternatingly between the plurality of
third elongate members. For example, as is illustrated in FIG. 2,
the generally tubular braided flow diverting stent can be formed
with alternating round wires and rectangular wires wound helically
in both right handed and left handed helical directions.
[0025] Referring to FIG. 4, the plurality of first elongate members
preferably have a substantially round cross-sectional shape, such
as a substantially circular cross-sectional shape, for example,
although the one or more first elongate members may optionally have
a substantially oval cross-sectional shape, and can be formed by a
plurality of first wires, for example.
[0026] Referring to FIG. 3, the plurality of second elongate
members preferably have a substantially flat radially outer
surface. In another presently preferred aspect, the one or more
second elongate members typically have a cross-sectional height or
thickness H in a first direction and a cross-sectional width or
thickness W in a second direction perpendicular to the first
direction substantially greater than the cross-sectional height or
thickness in the first direction, and typically have a generally
rectangular or flattened aspect, and can be formed by a plurality
of wires, for example.
[0027] Referring to FIG. 4, the plurality of third elongate members
preferably have a substantially round cross-sectional shape, such
as a substantially circular cross-sectional shape, for example,
although the one or more first elongate members may optionally have
a substantially oval cross-sectional shape, and can be formed by a
plurality of wires, for example.
[0028] Referring to FIG. 3, the plurality of fourth elongate
members preferably have a substantially flat radially outer
surface. In another presently preferred aspect, the one or more
fourth elongate members typically have a cross-sectional height or
thickness H in a first direction and a cross-sectional width or
thickness W in a second direction perpendicular to the first
direction substantially greater than the cross-sectional height or
thickness in the first direction, and typically have a generally
rectangular or flattened aspect, and can be formed by a plurality
of wires, for example.
[0029] The pluralities of first, second, third and fourth elongate
members are preferably formed of a material selected from the group
consisting of stainless steel, nickel-titanium alloy, tantalum,
cobalt-chromium alloy, platinum, and the like, or of a polymer,
such as a shape memory polymer, or a bioabsorbable material such as
poly(D,L-lactic acid-co-glycolic acid) (PGLA), polycaprolactone
(PCL), or the like, and combinations thereof. In a presently
preferred aspect, some or all of the elongated members used are
composed of a bioabsorbable material. In another presently
preferred aspect, some or all of the elongate members optionally
may be made of a radio-opaque material to facilitate guidance under
imaging methods like fluoroscopy.
[0030] In the method of making the generally tubular braided flow
diverting stent of the second embodiment, a braider machine can be
loaded with alternating bobbins of round and rectangular wire in
both the right handed and left handed helical locations.
[0031] It will be apparent from the foregoing that while particular
forms of the invention have been illustrated and described, various
modifications can be made without departing from the spirit and
scope of the invention. Accordingly, it is not intended that the
invention be limited, except as by the appended claims.
* * * * *