U.S. patent application number 16/840412 was filed with the patent office on 2020-11-26 for systems and methods for treating aneurysms.
The applicant listed for this patent is Galaxy Therapeutics, Inc.. Invention is credited to Aamir Badruddin, Brett Follmer, Edgard Luiz Ramos Pereira, Arturo Rosqueta, Thomas J. Wolfe, Osama O. Zaidat.
Application Number | 20200367895 16/840412 |
Document ID | / |
Family ID | 1000004867926 |
Filed Date | 2020-11-26 |
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United States Patent
Application |
20200367895 |
Kind Code |
A1 |
Badruddin; Aamir ; et
al. |
November 26, 2020 |
SYSTEMS AND METHODS FOR TREATING ANEURYSMS
Abstract
A vaso-occlusive system configured for embolizing an aneurysm,
includes an implantable vaso-occlusive device coupled to a distal
end of an elongate pusher and having a collapsed delivery
configuration and an expanded, deployed configuration, wherein the
vaso-occlusive device includes a proximal end configured to seat
against the aneurysm adjacent the neck of the aneurysm, a distal
end configured to extend in the sac and away from the neck of the
aneurysm, and a central longitudinal axis, and wherein the
vaso-occlusive device is configured to be releasably coupled to the
distal end of the pusher at a releasable joint including either one
or both of the configurations in the list consisting of: (1) the
distal end of the pusher extends from the releasable joint at an
angle formed with the central longitudinal axis of between about 30
degrees and about 120 degrees, and (2) the releasable joint is
coupled at a location on the proximal end of the vaso-occlusive
device that is radially offset from the central longitudinal
axis.
Inventors: |
Badruddin; Aamir;
(Bolingbrook, IL) ; Zaidat; Osama O.;
(Lambertville, MI) ; Follmer; Brett; (Santa Clara,
CA) ; Pereira; Edgard Luiz Ramos; (Boca Raton,
FL) ; Rosqueta; Arturo; (San Jose, CA) ;
Wolfe; Thomas J.; (Shorewood, WI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Galaxy Therapeutics, Inc. |
Brookfield |
WI |
US |
|
|
Family ID: |
1000004867926 |
Appl. No.: |
16/840412 |
Filed: |
April 5, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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62852988 |
May 25, 2019 |
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62914442 |
Oct 12, 2019 |
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62975741 |
Feb 12, 2020 |
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62975744 |
Feb 12, 2020 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00867
20130101; A61B 17/12113 20130101; A61B 2090/3966 20160201; A61B
2017/1205 20130101; A61B 2017/12054 20130101; A61B 17/12177
20130101 |
International
Class: |
A61B 17/12 20060101
A61B017/12 |
Claims
1-39. (canceled)
40. A vaso-occlusive system configured for embolizing an aneurysm,
the aneurysm having a neck and a sac, the system comprising: an
elongate pusher configured to be slidably disposed within a
delivery catheter, the delivery catheter having a proximal end, a
distal end, and a delivery lumen extending therebetween; an
implantable vaso-occlusive device coupled to a distal end of the
pusher, the vaso-occlusive device configured for implantation in
the aneurysm sac and having a collapsed delivery configuration when
restrained within the delivery lumen of the delivery catheter, and
an expanded, deployed configuration after being delivered out of
the delivery lumen of the delivery catheter and into the aneurysm
sac, wherein the vaso-occlusive device comprises a proximal end
configured to seat against the aneurysm adjacent the neck of the
aneurysm, a distal end configured to extend in the sac and away
from the neck of the aneurysm, and a central longitudinal axis; and
wherein the vaso-occlusive device is configured to be releasably
coupled to the distal end of the pusher at a releasable joint,
wherein the releasable joint comprises either one or both of the
configurations in the list consisting of: (1) the distal end of the
pusher extends from the releasable joint at an angle formed with
the central longitudinal axis of between about 30 degrees and about
120 degrees, and (2) the releasable joint is coupled at a location
on the proximal end of the vaso-occlusive device that is radially
offset from the central longitudinal axis.
41. The system of claim 40, wherein the distal end of the pusher
extends from the releasable joint at an angle formed with the
central longitudinal axis of between about 40 degrees and about 100
degrees.
42. The system of claim 40, wherein the distal end of the pusher
extends from the releasable joint at an angle formed with the
central longitudinal axis of between about 45 degrees and about 90
degrees.
43. The system of claim 40, wherein the distal end of the pusher
extends from the releasable joint at an angle formed with the
central longitudinal axis of between about 75 degrees and about 90
degrees.
44. The system of claim 40, wherein the releasable joint is
directly attached to the proximal end of the vaso-occlusive
device.
45. The system of claim 40, wherein the vaso-occlusive device in
its expanded, deployed configuration has a maximum radius, and
wherein the location on the proximal end of the vaso-occlusive
device is radially offset from the central longitudinal axis at
least 10% of the maximum radius.
46. The system of claim 40, wherein the vaso-occlusive device in
its expanded, deployed configuration has a maximum radius, and
wherein the location on the proximal end of the vaso-occlusive
device is radially offset from the central longitudinal axis at
least 50% of the maximum radius.
47. The system of claim 40, wherein the vaso-occlusive device in
its expanded, deployed configuration has a maximum radius, and
wherein the location on the proximal end of the vaso-occlusive
device is radially offset from the central longitudinal axis at
least 75% of the maximum radius.
48. The system of claim 40, wherein the vaso-occlusive device in
its expanded, wherein the location on the proximal end of the
vaso-occlusive device is at a radial edge of the vaso-occlusive
device.
49. The system of claim 40, wherein the vaso-occlusive device
comprises a cover, and wherein the proximal end of the
vaso-occlusive device comprises a proximal face of the cover, the
cover further comprising a concavity opposite and distal to the
proximal face.
50. The system of claim 49, wherein the concavity is generally
arranged around the central longitudinal axis.
51. The system of claim 49, wherein the cover has a generally
circular outer shape.
52. The system of claim 40, wherein the vaso-occlusive device is
formed from a mesh material
53. The system of claim 52, wherein the mesh material comprises a
plurality of filaments.
54. The system of claim 53, wherein the plurality of filaments
comprises filaments comprising a nickel-titanium alloy.
55. The system of claim 53, wherein the plurality of filaments
comprises filaments comprising a radiopaque material.
56. The system of claim 53, wherein the plurality of filaments
comprises filaments comprising drawn filled tubes.
57. The system of claim 52, wherein the mesh material comprises an
inverted mesh tube having an outer layer and an inner layer, the
outer layer transitioning to the inner layer at an inversion
fold.
58. The system of claim 40, further comprising a selective
orientation catheter having a proximal end, a distal end, and a
lumen extending from the proximal end to the distal end, wherein
the lumen of the selective orientation catheter comprises a
non-circular cross-section at least at a distal region adjacent the
distal end of the selective orientation catheter, wherein the
vaso-occlusive device in its collapsed delivery configuration has a
substantially non-circular cross-section configured to fit into at
least the distal region of the lumen of the selective orientation
catheter in a keyed manner, such that the vaso-occlusive device is
deliverable from the lumen of the selective orientation catheter in
a particular rotational position.
59. The system of claim 58, wherein the non-circular cross-section
of the lumen of the selective orientation catheter comprises an
oval.
60. The system of claim 58, wherein the non-circular cross-section
of the lumen of the selective orientation catheter comprises an
ellipse.
61. The system of claim 58, wherein the non-circular cross-section
of the lumen of the selective orientation catheter comprises a
shape selected from the list consisting of: a dogbone shape, a
guitar shape, and a polygonal shape.
62. The system of claim 58, wherein the lumen of the selective
orientation catheter has a circular cross-section located at least
at its proximal end.
63. The system of claim 62, wherein the circular cross-section of
the lumen of the selective orientation catheter comprises a
circular cross-section region extending from the proximal end of
the selective orientation catheter and distally toward a proximal
end of the distal region.
64. The system of claim 63, further comprising a continuously
smooth transition region mating the circular cross-section region
and the distal region.
65. The system of claim 58, wherein the vaso-occlusive device in
its collapsed delivery configuration has a first transverse axis
and a second transverse axis, the first transverse axis orthogonal
to the second transverse axis, wherein a first transverse dimension
along the first transverse axis is different from a second
transverse dimension along the second transverse axis.
66. The system of claim 58, further comprising a introducer having
a proximal end, a distal end, and an introducer lumen extending
between the proximal end of the introducer and the distal end of
the introducer, the introducer lumen configured to hold the
expandable implant in its collapsed configuration while the
expandable implant is introduced into the lumen of the delivery
catheter at its proximal end, wherein the introducer comprises
collar adjacent its distal end having an inner transverse dimension
that increases from a proximal collar end to a distal collar end,
the collar configured to facilitate the transitioning of the
vaso-occlusive device from its expanded, deployed configuration to
its collapsed delivery configuration when traction is placed on the
elongate pusher by a user.
67. The system of claim 66, wherein the collar is removable from
the introducer by the user, after the vaso-occlusive device has
been placed into its collapsed delivery configuration within the
introducer lumen of the introducer.
68. The apparatus of claim 40, further comprising a connection tube
having a proximal end substantially flush with a proximal end of
the vaso-occlusive device, a distal end extending within the
vaso-occlusive device, and a lumen, wherein the distal end of the
pusher extends through the lumen of the connection tube and
comprises a plurality of radially extending protrusions located
distal to the distal end of the connection tube, the plurality of
radially extending protrusions forming a maximum transverse
dimension that is greater than a maximum diameter of the lumen of
the connection tube.
69. The apparatus of claim 68, further comprising an activator
configured to modify the plurality of radially extending
protrusions such that the distal end of the pusher can be fully
removed from the lumen of the connection tube.
Description
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS
[0001] This application claims the benefit of priority to U.S.
Provisional Patent Application No. 62/852,988, filed on May 25,
2019, U.S. Provisional Patent Application No. 62/914,442, filed on
Oct. 12, 2019, U.S. Provisional Patent Application No. 62/975,741,
filed on Feb. 12, 2020, and U.S. Provisional Patent Application No.
62/975,744, filed on Feb. 12, 2020, all of which are herein
incorporated by reference in their entirety for all purposes.
Priority is claimed pursuant to 35 U.S.C. .sctn. 119.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] The field of the invention generally relates to embolic
devices for filling spaces in the vascular system, including
cerebral aneurysms or left atrial appendages. In some case, the
embolic devices may be used to embolize native vessels.
Description of the Related Art
[0003] An embolic device may be used as a stand-alone device to
occlude and aneurysm, or may be used with an adjunctive device or
material.
SUMMARY OF THE INVENTION
[0004] In one embodiment of the present disclosure, a
vaso-occlusive system configured for embolizing an aneurysm, the
aneurysm having a neck and a sac, the system including an elongate
pusher configured to be slidably disposed within a delivery
catheter, the delivery catheter having a proximal end, a distal
end, and a delivery lumen extending therebetween, an implantable
vaso-occlusive device coupled to a distal end of the pusher, the
vaso-occlusive device configured for implantation in the aneurysm
sac and having a collapsed delivery configuration when restrained
within the delivery lumen of the delivery catheter, and an
expanded, deployed configuration after being delivered out of the
delivery lumen of the delivery catheter and into the aneurysm sac,
wherein the vaso-occlusive device includes a proximal face
configured to seat against a lower wall portion of the sac of the
aneurysm against the neck of the aneurysm and a concavity, opposite
the proximal face, and having a perimeter extending into the sac
and away from the neck of the aneurysm, the concavity arranged
around a longitudinal axis, and wherein the vaso-occlusive device
is configured to be releasably coupled to the distal end of the
pusher at a releasable joint, the distal end of the pusher
extending from the releasable joint at an angle formed with the
central longitudinal axis of between about 30 degrees and about 120
degrees.
[0005] In another embodiment of the present disclosure, a
vaso-occlusive system configured for embolizing an aneurysm, the
aneurysm having a neck and a sac, the system including an elongate
pusher configured to be slidably disposed within a delivery
catheter, the delivery catheter having a proximal end, a distal
end, and a delivery lumen extending therebetween, an implantable
vaso-occlusive device coupled to a distal end of the pusher, the
vaso-occlusive device configured for implantation in the aneurysm
sac and having a collapsed delivery configuration when restrained
within the delivery lumen of the delivery catheter, and an
expanded, deployed configuration after being delivered out of the
delivery lumen of the delivery catheter and into the aneurysm sac,
wherein the vaso-occlusive device includes a proximal face
configured to seat against a lower wall portion of the sac of the
aneurysm against the neck of the aneurysm and a concavity, opposite
the proximal face, and having a perimeter extending into the sac
and away from the neck of the aneurysm, the concavity arranged
around a longitudinal axis, and wherein the vaso-occlusive device
is configured to be releasably coupled to the distal end of the
pusher at a releasable joint, and wherein the releasable joint is
coupled at a location on the proximal face of the vaso-occlusive
device that is radially offset from the central longitudinal
axis.
[0006] In yet another embodiment of the present disclosure, a
vaso-occlusive system configured for embolizing an aneurysm, the
aneurysm having a neck and a sac, the system including an elongate
pusher configured to be slidably disposed within a delivery
catheter, the delivery catheter having a proximal end, a distal
end, and a delivery lumen extending therebetween, an implantable
vaso-occlusive device coupled to a distal end of the pusher, the
vaso-occlusive device configured for implantation in the aneurysm
sac and having a collapsed delivery configuration when restrained
within the delivery lumen of the delivery catheter, and an
expanded, deployed configuration after being delivered out of the
delivery lumen of the delivery catheter and into the aneurysm sac,
wherein the vaso-occlusive device includes a proximal face
configured to seat against a lower wall portion of the sac of the
aneurysm against the neck of the aneurysm and a concavity, opposite
the proximal face, and having a perimeter extending into the sac
and away from the neck of the aneurysm, the concavity arranged
around a longitudinal axis, and wherein the vaso-occlusive device
is configured to be releasably coupled to the distal end of the
pusher at a releasable joint, and wherein the releasable joint has
a characteristic chosen from the list consisting of: (1) the distal
end of the pusher extends from the releasable joint at an angle
formed with the central longitudinal axis of between about 30
degrees and about 120 degrees, and (2) the releasable joint is
coupled at a location on the proximal face of the vaso-occlusive
device that is radially offset from the central longitudinal
axis.
[0007] In still another embodiment of the present disclosure, a
system for embolizing an aneurysm includes an expandable implant
configured for placement within an aneurysm, the implant having a
collapsed configuration and an expanded configuration, the expanded
configuration having an asymmetric shape in relation to a
longitudinal axis, and a delivery catheter having a proximal end
and a distal end and a lumen extending from the proximal end to the
distal end, the lumen having a non-circular cross-section at least
at a distal region adjacent the distal end of the delivery
catheter, wherein expandable implant in its collapsed configuration
is configured to fit into the lumen in the distal region in a keyed
manner, such that the expandable implant is deliverable from the
lumen at the distal end of the delivery catheter in a particular
rotational position in relation to the longitudinal axis.
[0008] In yet another embodiment of the present disclosure, a
method for inserting an expandable implant includes providing an
introducer having a proximal end and a distal end and an introducer
lumen extending between the proximal end of the introducer and the
distal end of the introducer, the introducer lumen configured to
hold an expandable implant in its collapsed configuration while the
expandable implant is introduced into the lumen of the delivery
catheter at its proximal end, wherein the lumen of the delivery
catheter has a non-circular shape, and wherein the expandable
implant in its collapsed configuration has a substantially
non-circular shape, pushing the expandable implant out of the
introducer lumen and into the lumen of the delivery catheter such
that the substantially non-circular shape of the expandable implant
in its collapsed configuration is oriented in a keyed manner with
the non-circular shape of the lumen of the delivery catheter, and
advancing the expandable implant such that it is entirely within
the lumen of the delivery catheter.
[0009] In still another embodiment of the present disclosure, a
vaso-occlusive system configured for embolizing an aneurysm, the
aneurysm having a neck and a sac, the system includes an elongate
pusher configured to be slidably disposed within a delivery
catheter, the delivery catheter having a proximal end, a distal
end, and a delivery lumen extending therebetween, an implantable
vaso-occlusive device coupled to a distal end of the pusher, the
vaso-occlusive device configured for implantation in the aneurysm
sac and having a collapsed delivery configuration when restrained
within the delivery lumen of the delivery catheter, and an
expanded, deployed configuration after being delivered out of the
delivery lumen of the delivery catheter and into the aneurysm sac,
wherein the vaso-occlusive device includes a proximal end
configured to seat against the aneurysm adjacent the neck of the
aneurysm, a distal end configured to extend in the sac and away
from the neck of the aneurysm, and a central longitudinal axis, and
wherein the vaso-occlusive device is configured to be releasably
coupled to the distal end of the pusher at a releasable joint,
wherein the releasable joint includes either one or both of the
configurations in the list consisting of: (1) the distal end of the
pusher extends from the releasable joint at an angle formed with
the central longitudinal axis of between about 30 degrees and about
120 degrees, and (2) the releasable joint is coupled at a location
on the proximal end of the vaso-occlusive device that is radially
offset from the central longitudinal axis.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a perspective view of an occlusion device
according to an embodiment of the present disclosure.
[0011] FIG. 2 is a sectional view of the occlusion device according
to an embodiment of the present disclosure.
[0012] FIG. 3 is a sectional view of the occlusion device of FIG. 2
being delivered within a microcatheter.
[0013] FIG. 4 is a sectional view of the occlusion device of FIG. 2
being deployed from a microcatheter.
[0014] FIG. 5 is a detail sectional view of a distal end of the
occlusion device of FIG. 2.
[0015] FIGS. 6A-6C are sectional views of the delivery of an
occlusion device of an occlusion system into an aneurysm according
to an embodiment of the present disclosure.
[0016] FIGS. 7A-7C are sectional views of the delivery of an
occlusion device of an occlusion system into an aneurysm according
to an embodiment of the present disclosure.
[0017] FIGS. 8A-8C are sectional views of the delivery of an
occlusion device of an occlusion system into an aneurysm according
to an embodiment of the present disclosure.
[0018] FIG. 9 is a plan view of an occlusion device according to an
embodiment of the present disclosure.
[0019] FIG. 10 is a plan view of an occlusion device according to
an embodiment of the present disclosure.
[0020] FIG. 11 is a perspective view of the delivery of an
occlusion device of an occlusion system into an aneurysm according
to an embodiment of the present disclosure.
[0021] FIG. 12 is a perspective view of the delivery of an
occlusion device of an occlusion system into an aneurysm according
to an embodiment of the present disclosure.
[0022] FIG. 13 is a perspective view of the delivery of an
occlusion device of an occlusion system into an aneurysm according
to an embodiment of the present disclosure.
[0023] FIG. 14 is a perspective view of the delivery of an
occlusion device of an occlusion system into an aneurysm according
to an embodiment of the present disclosure.
[0024] FIG. 15 is a perspective view of the delivery of an
occlusion device of an occlusion system into an aneurysm according
to an embodiment of the present disclosure.
[0025] FIG. 16 is a perspective view of the delivery of an
occlusion device of an occlusion system into an aneurysm according
to an embodiment of the present disclosure.
[0026] FIG. 17 is a top view of a delivery catheter according to an
embodiment of the present disclosure.
[0027] FIG. 18 is a side view of the delivery catheter of FIG.
17.
[0028] FIG. 19 is a magnified cross-section view taken along line
19 of FIG. 18.
[0029] FIG. 20 is a top view of a delivery catheter according to an
embodiment of the present disclosure.
[0030] FIG. 21 is a side view of the delivery catheter of FIG.
20.
[0031] FIG. 22 is a magnified cross-section view taken along line
22 of FIG. 21.
[0032] FIG. 23 is a perspective view of a loading sheath according
to an embodiment of the present disclosure.
[0033] FIG. 24 is a perspective view of the loading sheath of FIG.
23 with an occlusion device restrained in its collapsed
configuration.
[0034] FIG. 25 is a perspective view of the loading sheath of FIG.
23 being changed to another configuration.
[0035] FIG. 26 is a perspective of the loading sheath of FIG. 23
being used to load an occlusion device into a proximal end of a
delivery catheter.
[0036] FIGS. 27A-27E are alternate configurations of the lumen of a
delivery catheter, according to embodiments of the present
disclosure.
[0037] FIG. 28 is a perspective view of an occlusion device
according to an embodiment of the present disclosure.
[0038] FIG. 29A is a side view of the occlusion device of FIG.
28.
[0039] FIG. 29B is a detail view of the detachment portion of the
occlusion device of FIG. 28, prior to detachment.
[0040] FIG. 29C is a detail view of the detachment portion of the
occlusion device of FIG. 28, during detachment.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0041] Aneurysms are abnormal bulging or weakening of a blood
vessel, often an artery, and can have many complications. A bulging
of the blood vessel can disrupt or put pressure on surrounding
tissues. Cerebral aneurysms can result in a variety of side
effects, such as impaired vision, impaired speech, impaired
balance, etc. Further, the aneurysm creates a volume that is not
along the main flow path of the blood through the blood vessel. It
therefore can serve as a location for blood to become stagnant and,
due to swirling eddy currents, can contribute to the formation of a
thromboembolism. If an aneurysm ruptures, it can cause severe
internal bleeding, which in cerebral arteries can often become
fatal.
[0042] Aneurysms can be treated externally with open surgery. Such
procedures typically involve closing off the entrance or "neck" of
the aneurysm with a device such as vascular clip, clamp or a
ligature. However, such open surgical procedures can be highly
invasive and may lead to trauma to the adjacent tissue and other
side effects.
[0043] Aneurysms can also be treated through endovascular
procedures. In one procedure, detachable lengths of wires (e.g.,
coils) are inserted into the interior volume of the aneurysm using
a catheter. The coils are intended to fill the volume of the
aneurysm to decrease the flow of blood into the aneurysm, inducing
stagnation of flow and stimulate clotting within the aneurysm. In
settings of large cerebral aneurysms, filling of the aneurysm with
multiple coils can lead to mass effect that may induce brain
swelling and be an independent cause for new symptoms. In another
procedure, for aneurysms with a relatively large neck, the
adjunctive use of stents assists with the retention of the coils
within the aneurysm. This approach may have a contraindication to
being used when treating ruptured aneurysm, due to the need for
additional anti-thrombotic medications. In another procedure, the
coils are held in the volume of the aneurysm with a temporary
balloon that is inflated in the blood vessel. The balloon is
deflated and removed once the mass of coils is secured. In still
another procedure, a stent device is placed in the artery to
promote flow of blood past the aneurysm. This leads to stagnation
of the blood within the aneurysm and thrombosis inside the aneurysm
volume. However, a side branch of a main artery in which the stent
device is placed may become trapped or "jailed," which can impede
access to the side branch. In other instances, the side branch can
become clotted off, possibly causing a stroke. Additionally, such a
procedure generally requires the use additional anti-thrombotic
medications, which limits the use of such devices in the setting of
treatment of ruptured aneurysms. The stent device is often formed
with a relatively tight weave. While the tight weave increases the
effectiveness of the stent device in diverting the blood flow, it
also impedes or prevents access to the volume of the aneurysm or
the jailed artery. In the event that the aneurysm fails to clot,
the obstruction of the aneurysm by the stent device prevents the
possibility of placing embolic devices inside the aneurysm.
Additional procedures such as the placement of additional stents or
open surgery may then be required to treat the residual.
[0044] Procedures that involve packing the volume of the aneurysm
can suffer from several common shortcomings. First, it can take
many coils of wire to fill the volume of the aneurysm, which is
time consuming and increases the time it takes to complete the
procedure. Further, the coils may be compacted over time to occupy
a smaller percentage of the total volume of the aneurysm. A great
enough compaction of the coils can be considered a recurrence of
the aneurysm and may require further treatment. Aneurysms are often
non-spherical in shape and may also or alternatively have mild to
severe angulations in relation to the vessel or vessels from which
they bulge or protrude. This may make the delivery and employment
of one or more aneurysm embolization device to the aneurysm a
technical and physical challenge. Systems are presented herein to
remedy the difficulties that may occur.
[0045] FIG. 1 illustrates an occlusion device 100 configured for
placement within an aneurysm. The occlusion device 100 comprises a
cover 102 having an outer diameter D. In some embodiments, the
cover 102 is circular, with substantially the same diameter D at
any transverse measurement around the perimeter. In other
embodiments, the cover 102 is non-circular, and may comprise an
ellipse, an oval, a polygon or other shapes. In the non-circular
embodiments, the cover 102 comprises a minimum transverse dimension
and a maximum transverse dimension. In the particular case of an
ellipse or an oval shape, the cover 102 comprises a major diameter
and a minor diameter. The minor diameter or minimum transverse
dimension is configured to be larger than a maximum transverse
dimension of an opening into the aneurysm (the neck portion). Thus,
the cover 102 is configured to completely cover the neck portion,
and thus to cause stagnation of blood within the aneurysm, leading
to occlusion. The cover 102 is constructed from a mesh (braided)
Nitinol (nickel-titanium alloy) tube 105 that is inverted on
itself, thus providing an outer facing surface 108 and an inner
facing surface 110. The mesh tube 105 is heat-formed such that
cover 102 comprises an expanded portion and a first end 104 and a
second end 106 of the tube 105 (FIG. 2) each comprise unexpanded
(or partially expanded) portions. A smooth fold 112 extends around
the circumference 114 of the cover 102 and represents the
transition between the outer facing surface 108 and the inner
facing surface 110. The fold 112 avoids any sharp edge that might
risk rupture of an aneurysm wall, or other anatomical damage. The
cover 102 includes a concavity 116 arranged around a longitudinal
axis 118. The cover 102 is fabricated as an inverted mesh tube 105
having a simple straight elongate configuration, and is
subsequently formed into the shape shown in FIG. 1, and heat set
into this shape. For example, the inverted mesh tube 105 may be
constructed as a single layer mesh tube formed of at least some
nickel-titanium alloy filaments, and then inverted on itself. The
inverted mesh tube 105 may then be placed into a die or mold
comprising one or more pieces, to hold it in the shape of the cover
102. Then, the cover 102 may be subjected to an elevated
temperature and then cooled, to lock in the shape, resulting in a
cover 102 having at least some superelastic properties.
[0046] As formed (e.g., heat-formed), the cover 102 has an expanded
configuration (shown in FIG. 1) and a collapsed configuration,
shown in FIG. 3. The cover 102 comprises two mesh layers, provided
by the outer facing surface 108 and the inner facing surface
110.
[0047] In some embodiments, the cover 102 may comprise some
nickel-titanium alloy filaments and some radiopaque elements,
comprising platinum, gold, tantalum, or alloys of any of these or
other radiopaque materials. In some embodiments, the filaments may
comprise drawn filled tubes (DFT), such as those comprising a
nickel-titanium alloy outer wall and a platinum core. The
radiopaque material allows the cover 102 to be visible on
radiographs or fluoroscopy. The occlusion device 100 may be
configured by controlling how much radiopaque material is used, by
either the ratio of radiopaque filaments to non-radiopaque
filaments, or by the amount of platinum core in the drawn filled
tubes. In this manner, the cover 102 can be selectively fabricated
to be sufficiently visible, but not over visible, e.g., overly
bright, such that other objects are obscured. In some embodiments,
whether any of the filaments comprise radiopaque materials or not,
a marker band 119 may be attached to the proximal end 120 of the
occlusion device 100, by adhesive or epoxy bonding, or swaging,
welding or other mechanical attachment.
[0048] A pusher 152, having a distal end 154 and a proximal end
156, may comprise a wire, a hypo tube, or another elongate
structure having column support is detachably coupled at its distal
end 154 to the proximal end 120 of the occlusion device 100. A
detachable joint 158 may comprise one of a number of detachment
systems, including but not limited to pressurized detachment,
electrolytic detachment mechanisms, hydraulic detachment
mechanisms, mechanical or interlocking detachment mechanisms,
chemical detachment mechanisms, heat-activated detachment systems,
or frictional detachment systems. During delivery, the pusher 152
is held on its proximal end 156 by a user and pushed in a forward
longitudinal direction 160 (FIGS. 3-4), in order to advance the
occlusion device 100 to the distal end 162 of a delivery catheter
150 (e.g., a microcatheter) having a delivery lumen 148. The
delivery catheter 150 may also include a proximal hub 137, such as
a luer connector.
[0049] In the embodiment of FIG. 2, the pusher 152 comprises an
outer tube 153 and an inner wire 151 coupled to each other.
Conductors (e.g., electrical wires) 147, 149 are electrically
coupled distally to the inner wire 151 and outer tube 153 (e.g., if
a metallic tube), and proximally to first and second
circumferential contacts 143, 145 which are carried on a hub 141
that is attached to the proximal end 156 of the pusher 152. The hub
141 has a cavity 138 into which the proximal end 156 of the pusher
152 is inserted and bonded. The hub 141 and its circumferential
contacts 143, 145 is reversibly couplable to a connector (not
shown) of a detachment controller (not shown), such as those known
in the art. The detachment of the occlusion device 100 from the
pusher 152 may be achieved by use of the detachment controller by
any of the detachment systems, including but not limited to
pressurized detachment, electrolytic detachment mechanisms,
hydraulic detachment mechanisms, mechanical or interlocking
detachment mechanisms, chemical detachment mechanisms,
heat-activated detachment systems, or frictional detachment
systems.
[0050] Turning to FIG. 5, the cover 102 of the occlusion device 100
in its expanded configuration includes a concavity 116 arranged
generally around a longitudinal axis 118. This does not require
that the longitudinal axis 118 be a complete axis of symmetry, as
the cover may or may be an elliptical shape, or another
non-circular shape. The pusher 152 extends from the detachable
joint 158 along its own longitudinal axis 135 that is not collinear
with the longitudinal axis 118. A non-zero angle .theta. is thus
formed between the two longitudinal axes 118, 135. The angle
.theta. may be between about 15 degrees and about 120 degrees, or
between about 30 degrees and about 120 degrees, or between about 40
degrees and about 100 degrees, or between about 45 degrees and
about 90 degrees, or between about 75 degrees and about 90 degrees.
This angulation aids in the delivery of the occlusion device 100 to
an aneurysm that has an angulated takeoff and/or that is located
along a tortuous artery or an artery having a severe bend, as will
be shown in FIGS. 6A-8C.
[0051] Furthermore, the outer facing surface 108 has a general
center point 133 at the longitudinal axis 118. The center point 133
(and longitudinal axis 118) are separated from the detachable joint
158 by a non-zero distance r. Thus, the detachable joint 158 is
radially offset from the longitudinal axis 118. The maximum radius
r.sub.MAX of the cover 102 is the largest radius measured from the
longitudinal axis 118 to the circumference 131, for example, at any
point on the circumference 131 on a generally circular cover, or at
a point along the circumference 131 (or in general, perimeter) that
is along a major axis, as in an ellipse. The phrase "radially
offset," when used herein, should be interpreted as meaning at
least about 5% radially offset. In some embodiments, the distance r
is at least about 10% of the maximum radius r.sub.MAX, at least
about 25% of the maximum radius r.sub.MAX, or at least about 50% of
the maximum radius, or at least about 75% of the maximum radius
r.sub.MAX. The offset (distance r) aids in the delivery of the
occlusion device 100 to an aneurysm that has an angulated takeoff
and/or that is located along a tortuous artery or an artery having
a severe bend, as will be shown in FIGS. 6A-8C.
[0052] Although in FIG. 5 there is both a non-zero angle .theta.
and a non-zero distance r, in other embodiments, there may be a
non-zero angle .theta. but a substantially zero distance r, as in
the occlusion device 500 of FIG. 10. In other embodiments, there
may be a non-zero distance r and a substantially zero degree angle
.theta., as in the occlusion device 600 of FIG. 9.
[0053] FIGS. 6A-8C illustrate arteries 702, 802, 902 having
sidewall aneurysms 700, 800, 900. The approach by catheter (e.g.,
delivery catheter/microcatheter 150) in a sidewall aneurysm is
often challenging when placing a single occlusion device. A distal
end 162 of the delivery catheter 150 may be supplied preshaped with
a particular curve, or may be steam shaped or shaped by other
manners by a user, to create a preferred curve, prior to the
insertion of the delivery catheter 150 into the patient's
vasculature, such that the delivery angle of occlusion devices 200,
300, 400 into the aneurysm 700, 800, 900 allows a delivery along an
axis that is substantially or somewhat parallel to a longitudinal
axis of the neck 706, 806, 906 of the aneurysm 700, 800, 900, or
substantially or somewhat parallel to a longitudinal axis of the
sac of the aneurysm 700, 800, 900 itself. However, the curvature of
the artery 702, 802, 902 or a small diameter of the artery 702,
802, 902 may make it difficult for a curved tip of a delivery
catheter 150 to fit in the artery 702, 802, 902, adjacent the neck
706, 806, 906. In other cases, the curved tip may not be able to
provide sufficient backup support for delivering the implant
(occlusion device). Occlusion devices 200, 300, 400 according to
the embodiments disclosed herein ameliorate the efficacy of
embolizations performed in these anatomical conditions by allowing
the user to choose particular device parameters that match the
anatomy.
[0054] In FIG. 6A an occlusion device 200 comprising a cover 202
detachably coupled to a pusher 252 at a detachable joint 258 is
delivered through a delivery catheter 150 to an aneurysm 700
extending from an artery 702. The aneurysm 700 includes a dome 704
and a neck 706. The occlusion device 200 is similar to the
occlusion device 100, but has a different angle .theta. and offset
distance r, as seen in FIG. 6A. The particular occlusion device 200
(e.g., size, specification, model) may be chosen by the attending
physician to fit the aneurysm 700, with the angle .theta. and
offset distance r particularly chosen to aid the delivery through
the artery 702 and into the aneurysm 700, and to optimize the
geometry of the system (e.g. delivery catheter 150 and occlusion
device 200) during detachment. The cover 202 has a concavity 216
and an outer perimeter 214, or circumference (FIG. 6C). In FIG. 6B,
the cover 202 is detached from the pusher 252 via the detachable
joint 258 in any one of the manners described in relation to the
occlusion device 100. The pusher 252 and the delivery catheter 150
are then removed from the patient, leaving the occlusion device 200
deployed within the aneurysm 700, as shown in FIG. 6C. The outer
facing surface 208 of the cover 202 is seated against a lower wall
portion 708 of the aneurysm 700 sac, against the neck 706 of the
aneurysm 700. The outer perimeter 214 extends into the sac, at
least at some of its portions, and extends in a direction
substantially away from the neck 706 of the aneurysm 700.
[0055] In FIG. 7A an occlusion device 300 comprising a cover 302
detachably coupled to a pusher 352 at a detachable joint 358 is
delivered through a delivery catheter 150 to an aneurysm 800
extending from an artery 802. The aneurysm 800 includes a dome 804
and a neck 806. The occlusion device 300 is similar to the
occlusion device 100, but has a different angle .theta. and offset
distance r, as seen in FIG. 7A. The particular occlusion device 300
(e.g., size, specification, model) may be chosen by the attending
physician to fit the aneurysm 800, with the angle .theta. and
offset distance r particularly chosen to aid the delivery through
the artery 802 and into the aneurysm 800, and to optimize the
geometry of the system (e.g. delivery catheter 150 and occlusion
device 300) during detachment. The cover 302 has a concavity 316
and an outer perimeter 314, or circumference (FIG. 7C). In FIG. 7B,
the cover 302 is detached from the pusher 352 via the detachable
joint 358 in any one of the manners described in relation to the
occlusion device 100. The pusher 352 and the delivery catheter 150
are then removed from the patient, leaving the occlusion device 300
deployed within the aneurysm 800, as shown in FIG. 7C. The outer
facing surface 308 of the cover 302 is seated against a lower wall
portion 808 of the aneurysm 800 sac, against the neck 806 of the
aneurysm 800. The outer perimeter 314 extends into the sac, at
least at some of its portions, and extends in a direction
substantially away from the neck 806 of the aneurysm 800.
[0056] In FIG. 8A an occlusion device 400 comprising a cover 402
detachably coupled to a pusher 452 at a detachable joint 458 is
delivered through a delivery catheter 150 to an aneurysm 900
extending from an artery 902. The aneurysm 900 includes a dome 904
and a neck 906. The occlusion device 400 is similar to the
occlusion device 100, but has a different angle .theta. and offset
distance r, as seen in FIG. 8A. The particular occlusion device 400
(e.g., size, specification, model) may be chosen by the attending
physician to fit the aneurysm 900, with the angle .theta. and
offset distance r particularly chosen to aid the delivery through
the artery 902 and into the aneurysm 900, and to optimize the
geometry of the system (e.g. delivery catheter 150 and occlusion
device 400) during detachment. The cover 402 has a concavity 416
and an outer perimeter 414, or circumference (FIG. 8C). In FIG. 8B,
the cover 402 is detached from the pusher 452 via the detachable
joint 458 in any one of the manners described in relation to the
occlusion device 100. The pusher 452 and the delivery catheter 150
are then removed from the patient, leaving the occlusion device 400
deployed within the aneurysm 900, as shown in FIG. 8C. The outer
facing surface 408 of the cover 402 is seated against a lower wall
portion 908 of the aneurysm 900 sac, against the neck 906 of the
aneurysm 900. The outer perimeter 414 extends into the sac, at
least at some of its portions, and extends in a direction
substantially away from the neck 906 of the aneurysm 900.
[0057] As can be seen in FIGS. 6A-8C, the particular angle .theta.
and/or offset distance r make possible optimized delivery and
deployment of the occlusion devices 200, 300, 400 within the
aneurysms 700, 800, 900. In FIGS. 6A and 7A, the delivery catheter
150 is shown having little or no curve formed onto its distal end
162. However, in FIG. 8A, the distal end 162 has a curve 163
preformed or physician-formed, to aid the delivery of the occlusion
device 400 into the aneurysm 900. The curve 163 is more or less
oriented along the plane of the page, with radius or radii or
curvature that are substantially orthogonal to the page (i.e.,
extend vertically from the page). However, because the occlusion
device 400 has a concave shape arrange around a longitudinal axis
418, and because the occlusion device 400 and pusher 452 together
form a structure that is asymmetric to the longitudinal axis 418,
it may be desirable to selectively control the oriental rotation of
the occlusion device 400 in relation to its longitudinal axis 418,
which would thus further control the overall orientation of the
occlusion device 400 in relation to the aneurysm 900.
[0058] Returning to FIG. 1, the cover 202 may be braided such that
the braiding, mesh, etc., is arranged somewhat symmetrically around
the longitudinal axis 118. However, it may also be desired in
alternative embodiments to asymmetrically form the braiding around
the longitudinal axis 118, such that when the cover 202 is
compressed into its collapsed configuration, it actually
preferentially favors (via structure and sliding mechanics) forming
a more linear structure, oriented more along the longitudinal axis
135 (FIG. 5). Thus, while compressed within the lumen 148 of the
delivery catheter 150, the longitudinal axis 118 and the "pseudo"
longitudinal axis 135 (because the cover 202 is now temporarily
deformed) are now forced into an angle .theta. of substantially 90
degrees (in relation to each other). That is, until the cover 202
is delivered from the lumen 148 of the delivery catheter 150,
allowing it to take its expanded configuration, and, via the memory
of the braid material, to conform to its true angle .theta.. The
asymmetric braiding may be achieved by using a braiding process or
automated braiding machine that varies the braid angle in an
oscillating or sinusoidal manner. For example, at a particular
clock location around the circumference 114 of the cover 202 (e.g.,
6 o'clock) the braid angle may equal a first value X and at another
clock location around the circumference 114 of the cover 202 (e.g.,
9 o'clock) the braid angle may equal a second value 0.8.times.. In
some embodiments, the second value may be between about 40% and
about 95% of the first value, or between about 50% and about 90% of
the first value, or between about 60% and about 85% of the first
value.
[0059] FIG. 9 illustrates an occlusion device 500 comprising a
cover 502 detachably coupled to a pusher 552 at a detachable joint
558. The cover 502 has an outer perimeter 514. The longitudinal
axis 518 of the cover 502 is radially offset from the longitudinal
axis 535 of the pusher 552 by a non-zero distance r. There is
substantially a zero angle between the longitudinal axis 518 of the
cover and the longitudinal axis 535 of the pusher 552.
[0060] FIG. 10 illustrates an occlusion device 600 comprising a
cover 602 detachably coupled to a pusher 652 at a detachable joint
658. The cover 602 has an outer perimeter 614. The longitudinal
axis 618 of the cover 602 is angled from the longitudinal axis 635
of the pusher 652 by a non-zero angle .theta.. There is
substantially a zero distance r between the longitudinal axis 618
of the cover and the longitudinal axis 635 of the pusher 652.
[0061] Though the occlusion devices 100, 200, 300, 400, 500, 600 as
described according to embodiments disclosed herein are shown
generally having a proximal convexity and a distal concavity, and
are configured to predominantly being placed in a lower (near the
neck) portion of an aneurysm, any other configuration for an
aneurysm occlusion device is also contemplated for use in
combination with the attachment/detachment geometries taught in the
embodiments disclosed. This includes devices configured to be the
only device implanted in the aneurysm, as well as devices
configured to be one or a plurality of devices implanted in the
aneurysm. FIGS. 11-16 illustrate six different occlusion systems
770, 772, 774, 776, 778, 780 being utilized to deliver a braided
shell 758 into an aneurysm 750 having a dome 752 and a neck 768.
The braided shell 758 has a longitudinal axis 756 and is configured
to fill a majority of the aneurysm 750 or in some cases
substantially all of the aneurysm 750 sac. The braided shell 758 is
braided or woven from filaments 760, and has a proximal end 751, a
distal end 753, and an intermediate portion 782. The aneurysm 750
has the geometry of a sidewall aneurysm in relation to left
extending artery 762 and right extending artery 764. The aneurysm
750 alternatively has the geometry of a terminal aneurysm in
relation to artery 754. An additional vessel 766 may also be
present. It may be desired to avoid the embolization of this vessel
766 in the process of embolizing the aneurysm 750.
[0062] In FIG. 11, the occlusion system 770 includes a pusher 784
that is detachably coupled to the proximal end 751 of the braided
shell 758 at a detachable joint 785. The pusher 784 extends from
the detachable joint 785 at a non-zero angle in relation to the
longitudinal axis 756 of the braided shell 758. The detachable
joint 785 is dimensionally offset a non-zero distance from the
longitudinal axis 756 of the braided shell 758. The offset side is
the same as the side that the pusher 784 extends. The occlusion
system 770 is shown in FIG. 11 being delivered from the artery 762,
though it may also be delivered from one or more other
arteries.
[0063] In FIG. 12, the occlusion system 772 includes a pusher 786
that is detachably coupled to the proximal end 751 of the braided
shell 758 at a detachable joint 787. The pusher 786 extends from
the detachable joint 787 at a non-zero angle in relation to the
longitudinal axis 756 of the braided shell 758. The detachable
joint 787 is dimensionally offset a non-zero distance from the
longitudinal axis 756 of the braided shell 758, which is located on
an opposite side of the longitudinal axis from the side that the
pusher 784 extends. The occlusion system 772 is shown in FIG. 12
being delivered from the artery 762, though it may also be
delivered from one or more other arteries.
[0064] In FIG. 13, the occlusion system 774 includes a pusher 788
that is detachably coupled to the proximal end 751 of the braided
shell 758 at a detachable joint 789. The pusher 788 extends from
the detachable joint 789 at a non-zero angle in relation to the
longitudinal axis 756 of the braided shell 758. The detachable
joint 789 is generally not offset from the longitudinal axis 756 of
the braided shell 758, but is instead coupled substantially at the
longitudinal axis 756. The occlusion system 774 is shown in FIG. 13
being delivered from the artery 762, though it may also be
delivered from one or more other arteries.
[0065] In FIG. 14, the occlusion system 776 includes a pusher 790
that is detachably coupled to the proximal end 751 of the braided
shell 758 at a detachable joint 791. The pusher 790 extends from
the detachable joint 791 at a substantially zero angle in relation
to the longitudinal axis 756 of the braided shell 758. The
detachable joint 791 is dimensionally offset a non-zero distance
from the longitudinal axis 756 of the braided shell 758. The
occlusion system 776 is shown in FIG. 14 being delivered from the
artery 754, though it may also be delivered from one or more other
arteries.
[0066] In FIG. 15, the occlusion system 778 includes a pusher 792
that is detachably coupled to the proximal end 751 of the braided
shell 758 at a detachable joint 793. The pusher 792 extends from
the detachable joint 793 at a non-zero angle in relation to the
longitudinal axis 756 of the braided shell 758. The detachable
joint 793 is dimensionally offset a non-zero distance from the
longitudinal axis 756 of the braided shell 758. The offset side is
opposite of the side that the pusher 792 extends. The occlusion
system 778 is shown in FIG. 15 being delivered from the artery 754,
though it may also be delivered from one or more other
arteries.
[0067] In FIG. 16, the occlusion system 780 includes a pusher 794
that is detachably coupled to the proximal end 751 of the braided
shell 758 at a detachable joint 795. The pusher 794 extends from
the detachable joint 795 at a non-zero angle in relation to the
longitudinal axis 756 of the braided shell 758. The detachable
joint 795 is not offset from the longitudinal axis 756 of the
braided shell 758, but is instead coupled substantially at the
longitudinal axis 756. The occlusion system 780 is shown in FIG. 16
being delivered from the artery 754, though it may also be
delivered from one or more other arteries.
[0068] As can be seen in FIGS. 11-16, the angle .theta. and/or
offset distance r make possible optimized delivery and deployment
of the occlusion devices (braided shell 758) within the aneurysm
750.
[0069] FIGS. 17 and 18 illustrate a delivery catheter 10 comprising
a shaft 11 having a proximal end 12, a distal end 14 having a curve
16, and a non-circular lumen 18. A luer hub 13 is bonded to the
proximal end 12 of the shaft 11. In some embodiments, the
non-circular lumen 18 may extend through the entirety of the shaft
11, but in the embodiment of FIGS. 17 and 18, the non-circular
lumen 18 morphs into a circular lumen 20 (FIG. 19) at the proximal
end 12. In some embodiments, the shaft 11 may be extruded with a
circular lumen 20 its entire length, and then a non-circular
cross-section mandrel may be placed in the lumen 20 at the distal
end 14, and heat may be applied to reform the lumen 20 at the
distal end 14 to have the non-circular lumen 18 shape. In other
embodiments, a first tubular portion 22 having a circular lumen 20
may be thermally fused to a second tubular portion 24 having a
non-circular lumen 18. The mandrel may be placed from the proximal
end, and have smooth transitions between a circular outer
cross-section and a non-circular outer cross-section, in order to
form a transition zone 26 comprising a continuously smooth luminal
wall surface transition between the circular lumen 20 and the
non-circular lumen 18. The non-circular lumen 18 is illustrated in
FIG. 17 as an ellipse, buy may alternately by an oval, or any type
of non-circular cross-sectional shape. For example, a polygonal
shape, a dogbone shape, a guitar shape, or a U-shape. Optionally,
to further aid visualization on fluoroscopy (e.g., biplane
fluoroscopy), a radiopaque stripe 28 may be extruded or otherwise
placed on one side of the wall 30 of the shaft 11. Thus, a
physician delivering the delivery catheter 10 is able to better
judge the orientation (the clock position of rotation) of the curve
16 in relation to an aneurysm. The non-circular lumen 18 allows an
occlusion device whose compressed or constrained profile is
substantially oval or elliptical, or otherwise non-circular, to be
selectively oriented rotationally, for example, such that it can
only be placed at 0.degree., or placed at 180.degree., or at
another angle of rotation. A marking 15 on the luer hub 13 can be
used to aid the insertion of the occlusion device such that it is
oriented at a particular one of the 0.degree. or 180.degree.
orientation, by serving as a comparative visual aid. In some
embodiments, longitudinal stripes may be placed on the shaft 11
near the distal end 14, to allow steam shaping of the curve 16 (if
not preshaped), or reshaping of the curve 16, along a desired
plane. In some embodiments, steam shaping can be done by placing a
bendable mandrel within the non-circular lumen 18 to further or
alternatively aid the shaping or reshaping of the curve 16 along a
desired plane. In some embodiments, the bendable mandrel has a
similar cross-section shape as the non-circular lumen 18, such that
it substantially fills the non-circular lumen 15.
[0070] FIGS. 20 and 21 illustrate a delivery catheter 32 comprising
a shaft 34 having a proximal end 36, a distal end 38 having a curve
40, and a non-circular lumen 42. A luer hub 44 is bonded to the
proximal end 36 of the shaft 34. In this particular embodiment, the
non-circular lumen 42 extends through the entirety of the shaft 34.
The non-circular lumen 42 is illustrated in FIG. 20 as a guitar
shape having a first, smaller lobe 46 and a second, larger lobe 48
that are joined together by a waist 50. The guitar shape thus
creates a key for allowing only one particular rotational
positional of the occlusion device when it exits from the lumen 42
at the distal end 38 of the shaft 34, and thus, into the aneurysm.
In some embodiments, the non-circular lumen 42 may taper down in
size near the distal end 38 of the shaft 34. Thus, the occlusion
device is held substantially tightly near the distal end 38 of the
shaft 34, but there is more space through most of the length of the
lumen 42, to minimize axial friction. Any other type of "keyed"
shape may alternatively be used for the non-circular lumen 42.
Optionally, to further aid visualization on fluoroscopy (e.g.,
biplane fluoroscopy), a longitudinal radiopaque stripe 52 may be
extruded or otherwise placed on one side of the wall 54 of the
shaft 34.
[0071] Turning to FIGS. 23-26, a loading sheath (or introducer
sheath or insertion sheath) 56 is configured to aid in the
insertion of an asymmetric occlusion device 58 (or asymmetric
occlusion device 58/pusher 59/detachable joint 61 system) into the
non-circular lumen 60 (FIG. 26) of a delivery catheter 62. The
non-circular lumen 60 may only extend within the shaft 64 of the
catheter 62, or the luer hub 66 itself may also have the
non-circular lumen 60 (as illustrated in FIG. 26). A removable
funnel 68 has a proximal end 70 attached to a distal end 72 of the
loading sheath 56. The funnel 68 has a proximal inner diameter 74
(FIG. 25) that matches the diameter 76 at the distal end 72 of the
loading sheath 56. The funnel 68 smoothly tapers up to an increased
inner diameter 78 at a distal end 80. In use, the occlusion device
58 may be packaged inside the lumen 82 of the loading sheath 56 or
may be packaged extending from the loading sheath 56. Prior to
insertion into the non-circular lumen 60 of the delivery catheter
62, the occlusion device 58 may be prepared by priming or flushing
the lumen 82 (FIG. 23) of the loading sheath 56. The occlusion
device 58 may be examined or rinsed in saline or in saline and
heparin, external to the loading sheath 56, as shown in FIG. 23.
The user then carefully applies traction on (pulls) the pusher 59
to load the occlusion device 58 into the lumen 82 of the loading
sheath 56 in the preferred compressed configuration. For example,
with folded portions oriented in the most low-profile manner, or
with the preferred distally extending portions configured such that
they will exit the lumen 82 first. The inner contours of the funnel
68 optimize the ability to preferentially load the occlusion device
58 into the lumen 82. For example, the preferential loading may be
done in a manner to obtain the smallest possible compressed or
collapsed diameter. The loaded occlusion device 58 is shown in FIG.
24, fully within the lumen 82 of the loading sheath 56. As shown in
FIG. 25, the funnel 68 can then be snapped off, unscrewed from, or
otherwise removed from the loading sheath 56. The funnel 68 can
then be removed and discarded. In some embodiments, the funnel 68
may be reattachable to the loading sheath 56 Turning to FIG. 26,
the distal end 72 of the loading sheath 56 is placed close to the
entrance of the non-circular lumen 60 such that, for example, a
larger profile lobe 84 of the compressed occlusion device 58 can be
matched for entry into the larger lobe 86 of the non-circular lumen
60, and a smaller profile lobe 88 of the occlusion device 58 can be
matched for entry into the smaller lobe 90 of the non-circular
lumen 60. The pusher 59 is then pushed by the user to load the
occlusion device 58 in the non-circular lumen 60, and to advance
the occlusion device 58 toward the distal end (not shown) of the
delivery catheter 62. The loading sheath 56 may be peel-away, or
may simply be pulled back to a proximal portion of the pusher 59.
The occlusion device 58 can now be reliably delivered to an
aneurysm in the chosen orientation. For example, correct-side-up,
instead of upside-down. In some embodiments, the loading sheath may
have external longitudinal stripes on the tubing to aid the user in
applying the desired rotational orientation when inserting the
occlusion device 58.
[0072] Alternative luminal shapes and occlusion device compressed
shapes are shown in FIGS. 27A-27E. In the embodiment of FIG. 27A,
the distal end 852 of a delivery catheter 850 has a non-circular
lumen 854 having a pentagonal shape. An occlusion device 856 in its
compressed configuration favors a substantially pentagonal shape
that is keyable to the shape of the non-circular lumen 854. In the
embodiment of FIG. 27B, the distal end 858 of a delivery catheter
860 has a non-circular lumen 862 having a diamond shape. An
occlusion device 864 in its compressed configuration favors a
substantially diamond shape that is keyable to the shape of the
non-circular lumen 862. In the embodiment of FIG. 27C, the distal
end 866 of a delivery catheter 868 has a non-circular lumen 870
having a U-shape. An occlusion device 872 in its compressed
configuration favors a substantially U-shape that is keyable to the
shape of the non-circular lumen 870. In the embodiment of FIG. 27D,
the distal end 874 of a delivery catheter 876 has a non-circular
lumen 878 having an oval shape. An occlusion device 880 in its
compressed configuration favors a substantially oval shape that is
keyable to the shape of the non-circular lumen 878. In the
embodiment of FIG. 27E, the distal end 882 of a delivery catheter
884 has a non-circular lumen 886 having a guitar shape. An
occlusion device 888 in its compressed configuration favors a
substantially guitar shape that is keyable to the shape of the
non-circular lumen 886.
[0073] FIGS. 28-29C illustrate an occlusion device 1040 comprising
a mesh cover 1042 including a distal concavity 1044. A radially
offset internal tube 1046 having a lumen 1048 and an outer wall
1050 is secured within the mesh cover 1042, such that its proximal
end 1052 is flush or closely adjacent to a proximal end 1054 of the
mesh cover 1042. A pusher 1056 comprises a wire having a distal end
1058 including a plurality of radially-extending fingers 1060 which
extend from the distal end 1058. The fingers 1060 are configured to
be meltable, detachable, unbendable, breakable, ablatable,
deformable, or otherwise changeable. Prior to detachment, the
radially-extending fingers 1060 create a maximum diameter that is
larger than the diameter of the lumen 1048 of the internal tube
1046, such that traction on the wire of the pusher 1056 causes the
fingers 1060 to pull on the distal end of the outer wall 1050 of
the internal tube 1046, and thus the pull the entire occlusion
device 1040. For example, the occlusion device 1040 may be advanced
into an aneurysm, and if the user does not believe the fit or
configuration of the occlusion device 1040 within the aneurysm is
desirable, the user may pull on the pusher 1056 to pull the
occlusion device 1040 out of the aneurysm and into the lumen of the
delivery catheter. However, then the occlusion device 1040 has been
delivered into the aneurysm in an acceptable manner, the user may
detach by any detachment manner (to deform, damage, or destroy the
fingers 1060), via modes including but not limited to pressurized
detachment, electrolytic detachment mechanisms, hydraulic
detachment mechanisms, mechanical or interlocking detachment
mechanisms, chemical detachment mechanisms, heat-activated
detachment systems, or frictional detachment systems. In one
embodiment, mechanical detachment is achieved by pushing the distal
end of the microcatheter against the proximal end 1054 of the mesh
cover 1042 while pulling on the pusher 1056, thus bending the
fingers 1060, and removing the pusher 1056 from the occlusion
device 1040. The internal tube 1046 provides for a smooth proximal
end 1054 of the mesh cover 1042, and thus no remnant wire
protruding proximally. Remnant protruding wires could cause
thrombosis, which may cause embolic stroke. In some embodiments,
the distal end 1058 of the pusher 1056 may taper down to as small
as 0.001 inch or 0.002 inch, for example, if the distal end 1058
comprises a stainless steel wire. The internal tube 1046 may
comprise a polyimide tube, and may have an internal diameter as
small as 0.002 inch to 0.010 inch and an outer diameter of between
about 0.003 inch and about 0.014 inch. In some embodiments there
may be two fingers 1060, or three fingers 1060, or four fingers
1060, or five fingers 1060, of six fingers, 1060, or more.
[0074] The flush or adjacent relation of the proximal end 1052 of
the internal tube 1046 to a proximal end 1054 of the mesh cover
1042 assures that there is no detachment remnant extending
substantially proximal to the proximal end 1054 of the mesh cover
1042 (and into the parent artery). Thus, any potentially related
thromboembolic events may be avoided, in cases wherein such a
remnant would be a risk.
[0075] While the foregoing is directed to embodiments of the
present disclosure, other and further embodiments may be devised
without departing from the basic scope thereof. The filament
diameter of the filaments comprising any of the mesh material
(e.g., mesh tube including inverted mesh tubes) described herein
may be between about 0.0004 inch and about 0.003 inch, or between
about 0.0005 inch and about 0.002 inch, or between about 0.0006
inch and about 0.002 inch, or between about 0.0006 inch and about
0.0015 inch. The drawn filled tubes (DFT) may comprise between 0%
and 100% of the total strands/filaments in any of the braided/mesh
tubes. In some embodiments, the drawn filled tubes (DFT) comprise
about 50% to about 100% of the total filaments of the cover and
about 50% to about 100% of the total filaments of each of the
doubled-over or looped tubular mesh. The radiopaque core of each of
at least some of the drawn filled tubes has a cross-sectional area
that is between about 10% and about 70% of the total
cross-sectional area of the each of at least some of the drawn
filled tubes, or between about 51% and about 70% of the total
cross-sectional area of the each of at least some of the drawn
filled tubes. In some embodiments, NiTi #1-DFT.RTM. wire produced
by Fort Wayne Metals Research Products Corp. (Fort Wayne, Ind. USA)
may be utilized. The filaments may be braided with patterns having
filament crossings that are in any one or more of the following
ratios of filaments: 1.times.1, 1.times.2, 2.times.1, 2.times.2,
2.times.3, 3.times.2, 3.times.3, etc. (e.g., warp and weft). Any
low, moderate, or high pick counts may be used, for example,
between about 15 picks per inch and about 300 picks per inch, or
between about 20 picks per inch and about 160 picks per inch. Any
of the filaments or any of the portion of the occlusion devices may
be coated with compounds that enhance endothelialization, thus
improving the healing process when implanted within the aneurysm,
and optimizing occlusion. The pusher and occlusion device
configurations presented herein may also be used for in other types
of implantable devices, such as stents, flow diversion devices,
filters, and occlusion devices for structural heart defects.
[0076] Additional materials may be carried on a proximal portion of
the occlusion device, and configured to face opposite the aneurysm
neck. In some embodiments, the material on the occlusion device may
comprise a biological layer, configured to encourage growth. In
some embodiments, the biological layer may comprise antibodies, in
order to accelerate the formation of an endothelial layer, for
example, by attracting endothelial progenitor cells (EPCs). In some
embodiments, the biological layer may comprise a natural membrane
or structure, such as a membrane, such as a membrane from an ear,
or a cornea, or an ultra-thin piece of ligament, or even a piece of
blood vessel wall. In some embodiments, the material on the
occlusion device may comprise a polymer layer configured to act as
a simulated arterial wall. In some embodiments, the polymer layer
may comprise polytetrafluoroethylene, such as expanded
polytetrafluoroethylene (ePTFE), such as that used in grafts.
[0077] The ranges disclosed herein also encompass any and all
overlap, sub-ranges, and combinations thereof. Language such as "up
to," "at least," "greater than," "less than," "between," and the
like includes the number recited. Numbers preceded by a term such
as "approximately", "about", and "substantially" as used herein
include the recited numbers (e.g., about 10%=10%), and also
represent an amount close to the stated amount that still performs
a desired function or achieves a desired result. For example, the
terms "approximately", "about", and "substantially" may refer to an
amount that is within less than 10% of, within less than 5% of,
within less than 1% of, within less than 0.1% of, and within less
than 0.01% of the stated amount.
[0078] For purposes of the present disclosure and appended claims,
the conjunction "or" is to be construed inclusively (e.g., "an
apple or an orange" would be interpreted as "an apple, or an
orange, or both"; e.g., "an apple, an orange, or an avocado" would
be interpreted as "an apple, or an orange, or an avocado, or any
two, or all three"), unless: (i) it is explicitly stated otherwise,
e.g., by use of "either . . . or," "only one of," or similar
language; or (ii) two or more of the listed alternatives are
mutually exclusive within the particular context, in which case
"or" would encompass only those combinations involving
non-mutually-exclusive alternatives. For purposes of the present
disclosure and appended claims, the words "comprising,"
"including," "having," and variants thereof, wherever they appear,
shall be construed as open-ended terminology, with the same meaning
as if the phrase "at least" were appended after each instance
thereof.
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