U.S. patent application number 16/916874 was filed with the patent office on 2021-01-14 for stroke prevention devices, systems, and methods.
This patent application is currently assigned to CVDevices, LLC. The applicant listed for this patent is CVDevices, LLC. Invention is credited to Hyo Won Choi, Ghassan S. Kassab, Jose A. Navia, SR..
Application Number | 20210007866 16/916874 |
Document ID | / |
Family ID | 1000005109504 |
Filed Date | 2021-01-14 |
![](/patent/app/20210007866/US20210007866A1-20210114-D00000.png)
![](/patent/app/20210007866/US20210007866A1-20210114-D00001.png)
![](/patent/app/20210007866/US20210007866A1-20210114-D00002.png)
![](/patent/app/20210007866/US20210007866A1-20210114-D00003.png)
![](/patent/app/20210007866/US20210007866A1-20210114-D00004.png)
![](/patent/app/20210007866/US20210007866A1-20210114-D00005.png)
![](/patent/app/20210007866/US20210007866A1-20210114-D00006.png)
![](/patent/app/20210007866/US20210007866A1-20210114-D00007.png)
![](/patent/app/20210007866/US20210007866A1-20210114-D00008.png)
![](/patent/app/20210007866/US20210007866A1-20210114-D00009.png)
![](/patent/app/20210007866/US20210007866A1-20210114-D00010.png)
View All Diagrams
United States Patent
Application |
20210007866 |
Kind Code |
A1 |
Kassab; Ghassan S. ; et
al. |
January 14, 2021 |
STROKE PREVENTION DEVICES, SYSTEMS, AND METHODS
Abstract
Deflection devices, systems, and methods for the prevention of
stroke. Devices hereof comprise an extension portion and an anchor
portion, both of which are configured to prevent the device from
advancing into the artery extending from the aortic arch in which
the device may be positioned. Additionally, a retrieval system is
provided, the system comprising a sleeve catheter and a retrieval
device slidably disposed therein. The distal end of the retrieval
device comprises one or more attachment portions configured to
engage at least a portion of the anchor portion of a device
positioned within an artery extending from the aortic arch.
Inventors: |
Kassab; Ghassan S.; (La
Jolla, CA) ; Choi; Hyo Won; (San Diego, CA) ;
Navia, SR.; Jose A.; (Buenos Aires, AR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CVDevices, LLC |
San Diego |
CA |
US |
|
|
Assignee: |
CVDevices, LLC
San Diego
CA
|
Family ID: |
1000005109504 |
Appl. No.: |
16/916874 |
Filed: |
June 30, 2020 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
15584469 |
May 2, 2017 |
10695199 |
|
|
16916874 |
|
|
|
|
14546601 |
Nov 18, 2014 |
9636204 |
|
|
15584469 |
|
|
|
|
15377103 |
Dec 13, 2016 |
10470903 |
|
|
15584469 |
|
|
|
|
13264508 |
Oct 14, 2011 |
9517148 |
|
|
PCT/US10/31475 |
Apr 16, 2010 |
|
|
|
15377103 |
|
|
|
|
61905509 |
Nov 18, 2013 |
|
|
|
61169767 |
Apr 16, 2009 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/966 20130101;
A61F 2002/821 20130101; A61F 2250/0039 20130101; A61F 2/82
20130101; A61F 2230/0069 20130101; A61F 2/01 20130101; A61F
2230/0067 20130101; A61F 2/90 20130101; A61F 2/011 20200501; A61F
2250/0098 20130101; A61F 2/86 20130101; A61F 2230/0078 20130101;
A61F 2002/016 20130101 |
International
Class: |
A61F 2/86 20060101
A61F002/86; A61F 2/966 20060101 A61F002/966; A61F 2/01 20060101
A61F002/01 |
Claims
1. A stroke prevention device, the stroke prevention device
comprising: an extension portion having a first end and a second
end, the extension portion sized and shaped to fit within an artery
extending from an aortic arch; an anchor portion comprising a
plurality of wings coupled with the second end of the extension
portion, the anchor portion sized and shaped to prevent the stroke
prevention device from advancing into the artery extending from the
aortic arch in which the first end of the extension portion may be
positioned and each comprising a first attachment portion; and two
or more parallel convex struts positioned across an opening defined
within the second end of the extension portion, the two or more
parallel convex struts configured to divert an embolus from
entering the artery when the first end of the extension portion is
positioned within the artery; wherein the first attachment portion
of the anchor portion of the stroke prevention device is configured
to be engaged by an attachment portion of a retrieval device to
remove the stroke prevention device from the artery.
Description
PRIORITY
[0001] This application is related to, claims the priority benefit
of, and is a U.S. continuation application of, U.S. patent
application Ser. No. 15/584,469 filed May 2, 2017 and issued as
U.S. Pat. No. 10,695,199 on Jun. 30, 2020, which (a) is related to,
and claims the priority benefit of, U.S. patent application Ser.
No. 14/546,601, filed Nov. 18, 2014 and issued as U.S. Pat. No.
9,636,204 on May 2, 2017, which is related to, and claims the
priority benefit of, U.S. Provisional Patent Application Ser. No.
61/905,509, filed Nov. 18, 2013, and (b) is related to, claims the
priority benefit of, and is a U.S. continuation-in-part application
of, U.S. patent application Ser. No. 15/377,103, filed Dec. 13,
2016, which is related to, claims the priority benefit of, and is a
U.S. continuation application of, U.S. patent application Ser. No.
13/264,508, filed Oct. 14, 2011 and issued as U.S. Pat. No.
9,517,148 on Dec. 13, 2016, which is related to, and claims the
priority benefit of, International Application Serial No.
PCT/US10/31475, filed Apr. 16, 2010, which is related to, and
claims the priority benefit of, U.S. Provisional Patent Application
Ser. No. 61/169,767, filed Apr. 16, 2009. The entire contents of
the aforementioned priority and related applications are hereby
incorporated by reference in their entirety into this
disclosure.
BACKGROUND
Stroke
[0002] A stroke is defined as a rapidly developing loss of brain
function due to a disturbance in the blood supply to the brain.
This can be due to ischemia (lack of blood supply) caused by
thrombosis or embolism or due to a hemorrhage. As a result, the
affected area of the brain is unable to function, leading to the
inability to move one or more limbs on one side of the body, the
inability to understand or formulate speech, or the inability to
see one side of the visual field amongst others.
[0003] Each year, about 800,000 people experience a new or
recurrent stroke. Approximately 600,000 of these are first attacks,
and 200,000 are recurrent attacks. In addition, and on average,
someone in the U.S. has a stroke every 40 seconds, and each year,
about 55,000 more women than men have a stroke. On average, every
3-4 minutes, someone dies of a stroke. Because women live longer
than men, more women than men die of stroke each year. Women
accounted for 60.6% of U.S. stroke deaths in 2005. Men stroke
incidence rates are greater than women at younger ages but not at
older ages. Despite advances in stroke prevention treatments, the
incidence of hospitalized stroke and case fatality did not
decrease. African-Americans have almost twice the risk of
first-ever stroke than whites. The age adjusted stroke incidence
rates in people 45-84 years of age are 6.6 per 1000 population in
black men, 3.6 in white men, 4.9 in black women, and 2.3 in white
women.
[0004] Of all strokes, 87% are ischemic, 10% are intracerebral
hemorrhage, and 3% are subarachnoid hemorrhage strokes. Stroke
accounted for about 1 out of every 17 deaths in the U.S. in 2005,
and approximately 53% of stroke deaths in 2005 occurred out of the
hospital.
[0005] Total stroke mortality in 2005 was about 150,000. The 2005
overall death rate for stroke was 46.6 per 100,000. Death rates
were 44.7 for white males, 70.5 for black males, 44.0 for white
females, and 60.7 for black females, all per 100,000. When
considered separately from other cardiovascular diseases, stroke
ranks no. 3 among all causes of death, behind heart disease and
cancer.
[0006] A report released by the Centers for Disease Control (CDC)
in collaboration with the Centers for Medicare and Medicaid
Services (CMS), the Atlas of Stroke Hospitalizations Among Medicare
Beneficiaries, found that in Medicare beneficiaries, 30-day
mortality rate varied by age: 9% in patients 65 to 74 years of age,
13.1% in those 74 to 84 years of age, and 23% in those 85 years of
age.
Atrial Fibrillation
[0007] Atrial fibrillation (AF) is a significant, independent risk
factor for ischemic stroke, increasing risk about 5-fold. The
percentage of strokes attributable to AF increases steeply from
1.5% at 50 to 59 years of age to 23.5% at 80 to 89 years of age.
Most strokes in patients with AF are cardioembolic caused by
embolism of left atrial appendage thrombi, but some are caused by
coexisting intrinsic cerebrovascular diseases in typically elderly,
often hypertensive patients.
[0008] AF carries an annual risk of thromboembolic complications of
3-6%, which is 5-7 times greater than that of controls with sinus
rhythm. AF is present in 15-21% of patients affected by stroke.
AF/flutter, a strong risk factor for stroke, is arguably the most
important finding on cardiac workup in patients with ischemic
stroke. Once identified, introduction of oral anticoagulant therapy
(warfarin, for example) provides a 40% risk reduction in recurrent
stroke compared with antiplatelet therapy. Ischemic stroke with AF
is associated with greater disability and mortality than those
without AF. However, not all patients can receive anticoagulant or
antiplatelet therapies, and the same or other patients may be prone
to clots that form in the left atrial appendage and enter the
bloodstream, so other types of therapies would be required.
[0009] Patients with AF have an increased risk of major, disabling
stroke, often caused by large infarctions in the middle cerebral
artery territory. Some studies showed that AF was associated with
an increased risk of death in the first four weeks after stroke
likely due to the advanced age in stroke patients with AF, large
infarction, severe neurological deficits, and poor functional
outcomes.
[0010] First, strokes in patients with AF may largely be
cardioembolic, which causes a sudden occlusion of large cerebral
arteries without sufficient collateral blood flow, resulting in
more severe strokes. Several studies have reported that stroke
patients with AF often have large cortical infarcts on computed
tomography, and less frequently have lacunar infarction as compared
with patients without AF.
Heart Failure
[0011] Patients with heart failure (HF) are at increased risk for
thromboembolic events. Left ventricular (LV) thrombus provides a
substrate for events and a rationale for anticoagulation.
Echocardiography studies have yielded conflicting results, however,
regarding thrombus prevalence. Among populations with similar
degrees of systolic dysfunction, studies have reported over a
20-fold difference in prevalence, ranging from 2.1% to 50%.
Moreover, when thrombus is identified, conflicting findings have
been reported concerning the risk of future embolic events.
[0012] The impact of nonrheumatic atrial fibrillation,
hypertension, coronary heart disease, and cardiac failure on stroke
incidence was examined in the Framingham Study. Compared with
subjects free of these conditions, the age-adjusted incidence of
stroke was more than doubled in the presence of coronary heart
disease and more than tripled in the presence of hypertension.
There was a more than fourfold excess of stroke in subjects with HF
and nearly fivefold increase when atrial fibrillation was present.
In persons with coronary heart disease or HF, atrial fibrillation
doubled the stroke risk in men and tripled the risk in women.
Factors that predispose to thromboembolic events in patients with
HF include low cardiac output, with relative stasis of blood in
dilated cardiac chambers, poor contractility and regional wall
motion abnormalities and concomitant atrial fibrillation.
BRIEF SUMMARY
[0013] In at least one exemplary embodiment of a device for the
prevention of stroke of the present disclosure, the device
comprises an extension portion, an anchor portion, and two or more
parallel, convex struts. The extension portion has a first end and
a second end and is sized and shaped to fit within an artery
extending from an aortic arch. The anchor portion comprises a
plurality of wings and is coupled with the second end of the
extension portion and sized and shaped to prevent the device from
advancing into the artery extending from the aortic arch in which
the first end of the extension portion may be positioned. In at
least one embodiment, the anchor portion comprises a flange
configuration. Alternatively, the anchor portion may comprise two
or more wings.
[0014] The two or more parallel convex struts of the device are
positioned across an opening defined within the second end of the
extension portion, the two or more parallel convex struts
configured to divert an embolus from entering the artery when the
first end of the extension portion is positioned within the artery.
In another embodiment, the two or more parallel convex struts
comprise four or more parallel convex struts. In an exemplary
embodiment, when the device is positioned within the artery
extending from an aortic arch, the two or more parallel convex
struts are positioned either approximately perpendicular to, in a
direction of (i.e. approximately parallel with), or in an oblique
manner relative to, blood flow within the aortic arch. In an
additional embodiment, the device comprises a stent. In yet an
additional embodiment, the anchor portion is autoexpandable from a
collapsed configuration to an expanded configuration.
[0015] In at least one exemplary embodiment of a device for the
prevention of stroke of the present disclosure, the extension
portion comprises a substantially cylindrical shape. In another
embodiment, the extension portion comprises an extension mesh
comprising multiple wires. In yet another embodiment, the extension
portion has a length between about 1.5 cm to about 2.5 cm. In an
additional embodiment, the extension portion has a diameter between
about 6 mm to about 8 mm when the extension portion is in an
expanded configuration. In yet an additional embodiment, the
extension portion has a diameter between about 1.8 mm to about 2.0
mm when the extension portion is in a compressed configuration.
[0016] In at least one exemplary embodiment of a device for the
prevention of stroke of the present disclosure, the device is
comprised of a material selected from the group consisting of
stainless steel, cobalt-chromium-nickel-molybdenum-iron alloy,
tantalum, nitinol, nickel-titanium, polymer materials, and a
shape-memory polymer.
[0017] In at least one exemplary embodiment of a device for the
prevention of stroke of the present disclosure, the device further
comprises one or more radiopaque markers positioned upon at least
one of the anchor portion, such as at one or more of the plurality
of wings. In an additional embodiment, the one or more radiopaque
markers are positioned relative to the two or more parallel convex
struts. In yet additional embodiments, when the first end of the
extension portion is positioned within the artery extending from an
aortic arch, the one or more radiopaque markers facilitate
alignment of the device so that the two or more parallel convex
struts are positioned either approximately perpendicular to, or in
a direction of (i.e. approximately parallel with), or in an oblique
manner relative to, blood flow within the aortic arch. In at least
one exemplary embodiment of a device for the prevention of stroke
of the present disclosure, the diameter of each of the two or more
parallel convex struts is between about 0.25 mm and about 1.0 mm,
inclusive. In another embodiment, the two or more parallel convex
struts are positioned between about 0.75 mm to about 1.0 mm,
inclusive, from one another. In yet another embodiment, the two or
more parallel convex struts are flexible. In various embodiments,
each wing of the plurality of wings comprises a wire forming a loop
relative to the second end of the extension portion. In at least
one embodiment, the extension portion comprises a stent frame
without an extension mesh coupled thereto or formed therein. In
various embodiments, the stent frame comprises a plurality of
extension struts connected to one another by way of one or more
connection struts.
[0018] In at least one exemplary embodiment of a retrieval system
for the prevention of stroke of the present disclosure, the system
comprises at least one device for the prevention of stroke, a
sleeve catheter and a retrieval device. The at least one device
comprises an extension portion having a first end and a second end
(the extension portion sized and shaped to fit within an artery
extending from an aortic arch), an anchor portion comprising a
plurality of wings and coupled with the second end of the extension
portion (the anchor portion sized and shaped to prevent the device
from advancing into the artery extending from the aortic arch in
which the first end of the extension portion may be positioned),
and two or more parallel convex struts positioned across an opening
defined within the second end of the extension portion, the two or
more parallel convex struts configured to divert an embolus from
entering the artery when the first end of the extension portion is
positioned within the artery. The sleeve catheter is configured for
intravascular insertion and advancement, the sleeve catheter
comprising a proximal end, an open distal end, and a lumen
extending therebetween, and the retrieval device slidably disposed
within the lumen of the sleeve catheter, the retrieval device
comprising a proximal end for manipulation by a user and a distal
end comprising one or more second attachment portions, wherein each
of the one or more second attachment portions of the retrieval
device are configured to engage the first attachment portion of the
anchor portion of the device. In another embodiment, the system
further comprises a conical dilator sized and shaped to slidingly
engage the hypotube. In yet another embodiment, the conical dilator
comprises a tapered distal and a proximal end. In an additional
embodiment, the folder has an inner diameter, and wherein the
tapered distal end of the conical dilator is sized and shaped to
fit within the inner diameter of the folder. In yet an additional
embodiment, when the device is positioned within the artery
extending from an aortic arch, the two or more parallel convex
struts either approximately perpendicular to, in a direction of
(i.e. approximately parallel with), or in an oblique manner
relative to, blood flow within the aortic arch. In another
embodiment, the retrieval device of the system comprises one or
more wires. In yet other embodiments, the system comprises two
devices for prevention of a stroke. Furthermore, in at least one
embodiment, the first attachment portion of the anchor portion
comprises a screw tip and a first magnet and the second attachment
portion of the retrieval device comprises a screw hole and a second
magnet, and the screw tip and the first magnet of the first
attachment portion are configured to securely engage with the screw
hole and the second magnet of the second attachment portion,
respectively. Additionally, in other embodiments, the second
attachment portion of the retrieval device comprises a lace
component and the first attachment portion of the anchor portion
comprises a hook tip configured to engage the lace component of the
retrieval device.
[0019] In at least one exemplary embodiment of a method for
preventing stroke of the present disclosure, the method comprises
the steps of introducing a device for preventing stroke into a
body, navigating the device within the body until the device
reaches an aortic arch, and positioning the device within a first
vessel branching from the aortic arch so that the two or more
convex struts are positioned either approximately perpendicular to,
or in a direction of (i.e. approximately parallel with), or in an
oblique manner relative to, blood flow within the aortic arch. In
another embodiment, in the step of introducing a device for
preventing stroke into a body, the device comprises an extension
portion having a first end and a second end, an anchor portion
comprising a plurality of wings and coupled with the second end of
the extension portion and sized and shaped to prevent the device
from advancing into the artery extending from the aortic arch in
which the first end of the extension portion may be positioned, and
two or more convex struts positioned across an opening defined
within the second end of the extension portion. Here, the extension
portion may be sized and shaped to fit within an artery extending
from the aortic arch and/or the two or more convex struts of the
device may be configured to divert an embolus from entering the
artery when the first end of the extension portion is positioned
within the artery. In yet another embodiment, the step of
positioning the device is performed by aligning the device within
the vessel by detecting one or more radiopaque markers positioned
upon the device. Furthermore, placement of the device within the
first vessel does not significantly affect upstream blood flow
patterns. In an additional embodiment, the step of positioning the
device comprises positioning the device within an innominate
artery.
[0020] In at least one exemplary embodiment of a method for
preventing stroke of the present disclosure, the method further
comprises the steps of introducing a second device for preventing
stroke into the body; navigating the second device within the body
until the second device reaches the aortic arch; and positioning
the second device within a second vessel branching from the aortic
arch. In this manner, two or more convex struts of the second stent
are positioned either approximately perpendicular to, in a
direction of (i.e. approximately parallel with), or in an oblique
manner relative to, blood flow within the aortic arch. In another
embodiment, the step of positioning the second device comprises
positioning the second device within a common carotid artery. In
yet another embodiment, the step of positioning the first device
comprises positioning the first device within an innominate artery,
wherein the first device is capable of diverting an embolus from
entering the innominate artery and the second device is capable of
diverting the embolus from entering the common carotid artery.
[0021] In at least one exemplary embodiment of a method for
preventing stroke of the present disclosure, the method further
comprises the step of anchoring the device within the first vessel
by deploying the extension portion and the anchor portion of the
device. Additionally, the step of anchoring the device within the
first vessel may further comprise moving the extension portion from
a collapsed position to an expanded position and moving the anchor
portion from a collapsed position to an expanded position. In yet
another exemplary embodiment of the method for preventing stroke of
the present disclosure, the method further comprises the steps of
retrieving the stent from the first vessel and removing the stent
from the body. In an additional embodiment, the steps of retrieving
the stent from within the first vessel and removing the stent from
the body further comprise the steps of: introducing a retrieval
system into the body, navigating the sleeve catheter within the
body until the open distal end of the sleeve catheter reaches an
aortic arch, advancing the distal end of the retrieval catheter
through the open distal end of the sleeve catheter so that the one
or more attachment portions engage the anchor portion of the
device, disengaging the device from the first vessel, and
withdrawing the device and the retrieval system from the body. In
yet another embodiment of the method, the step of introducing a
retrieval system into the body further comprises the retrieval
system comprising a sleeve catheter configured for intravascular
insertion and advancement, the sleeve catheter comprising a
proximal end, an open distal end, and a lumen extending
therebetween, and a retrieval device slidably disposed within the
lumen of the sleeve catheter, the retrieval device comprising a
proximal end for manipulation by a user and a distal end comprising
one or more attachment portions, each of which are configured to
engage the anchor portion of the device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] FIG. 1 shows a diagram of at least a portion of an aorta,
according to the present disclosure;
[0023] FIGS. 2A and 2B show exemplary embodiments of a device for
the prevention of stroke, according to the present disclosure;
[0024] FIG. 2C shows an embodiment of a device comprising a planar
flange, according to the present disclosure;
[0025] FIGS. 3A and 3B show side views of an embodiment of a device
comprising two or more wings, according to the present
disclosure;
[0026] FIG. 3C shows an interior view of the device of FIGS. 3A and
3B;
[0027] FIG. 4 shows a side view of an embodiment of a device for
the prevention of stroke comprising a stent frame according to the
present disclosure;
[0028] FIG. 5A shows exemplary devices for the prevention of stroke
positioned within arteries extending from a portion of an aorta
with the convex struts in alignment with blood flow, according to
the present disclosure;
[0029] FIG. 5B shows exemplary devices for the prevention of stroke
positioned within arteries extending from a portion of an aorta
with the convex struts in alignment approximately perpendicular to
blood flow, according to the present disclosure;
[0030] FIG. 6A shows an exemplary embodiment of a system for
preventing stroke, according to the present disclosure;
[0031] FIG. 6B shows an exemplary embodiment of a system for
preventing stroke, the system comprising a device having two or
more wings, according to the present disclosure;
[0032] FIGS. 7A and 7B show an exemplary system of the present
disclosure with portions thereof being moved to allow for device
deployment, according to the present disclosure;
[0033] FIGS. 8A and 8B show at least a portion of an exemplary
system for preventing stroke, said system comprising a conical
dilator useful to facilitate removal of at least a portion of the
exemplary system from the body, according to the present
disclosure;
[0034] FIGS. 9A and 9B show additional embodiments of an exemplary
system for preventing stroke, according to the present
disclosure;
[0035] FIGS. 10A-10E show various steps of a method for positioning
a device within a body, according to the present disclosure;
[0036] FIGS. 11A-11C show various steps of a method for retrieving
a device previously positioned within a body, according to the
present disclosure;
[0037] FIG. 12 shows at least a portion of an exemplary system for
retrieving two devices previously positioned within arteries
extending from a portion of an aorta, according to the present
disclosure;
[0038] FIGS. 13A and 13B show embodiments of an attachment portion
of the exemplary system for retrieving a device previously
positioned within a body; and
[0039] FIG. 14 shows a flow chart of an exemplary method for
preventing stroke according to the present disclosure.
[0040] An overview of the features, functions and/or configurations
of the components depicted in the various figures will now be
presented. It should be appreciated that not all of the features of
the components of the figures are necessarily described. Some of
these non-discussed features, such as various couplers, etc., as
well as other discussed features, are inherent from the figures
themselves. Other non-discussed features may be inherent in
component geometry and/or configuration.
DETAILED DESCRIPTION
[0041] For the purposes of promoting an understanding of the
principles of the present disclosure, reference will now be made to
the embodiments illustrated in the drawings, and specific language
will be used to describe the same. It will nevertheless be
understood that no limitation of the scope of this disclosure is
thereby intended. Furthermore, numerous specific details are set
forth in order to provide a thorough understanding of the present
disclosure. Particular examples may be implemented without some or
all of these specific details. In other instances, well known
devices or processes have not been described in detail so as to not
unnecessarily obscure the present disclosure.
[0042] Various systems, methods and techniques of the present
disclosure will sometimes describe a connection between two
components. Words such as attached, affixed, coupled, connected,
and similar terms with their inflectional morphemes are used
interchangeably, unless the difference is noted or made otherwise
clear from the context. These words and expressions do not
necessarily signify direct connections, but include connections
through mediate components and devices. It should be noted that a
connection between two components does not necessarily mean a
direct, unimpeded connection, as a variety of other components may
reside between the two components of note. Consequently, a
connection does not necessarily mean a direct, unimpeded connection
unless otherwise noted. Furthermore, wherever feasible and
convenient, like reference numerals are used in the figures and the
description to refer to the same or like parts or steps.
Additionally, the drawings are in a simplified form and not to
precise scale.
[0043] The disclosure of the present application provides various
devices, systems, and methods for the prevention of stroke. The
devices, systems, and methods disclosed herein facilitate stroke
prevention, in part, by addressing specific areas of the heart and
diverting the trajectories of blood clots away therefrom with
minimal to no influence on resistance of blood flow through such
areas and/or significantly affect upstream blood flow patterns.
[0044] A diagram of at least a portion of an exemplary aorta is
shown in FIG. 1. An aorta 100 is the main trunk of a vascular
system which conveys oxygenated blood to the tissues of a body. It
begins at the upper part of the left ventricle, where it may be
approximately 3 cm in diameter in an adult human. As shown in FIG.
1, and at the union of the ascending aorta 102 with the aortic arch
104 (or the "arch of aorta"), the caliber of the vessel is
increased, owing to a bulging of its right wall. This dilatation is
termed the aortic bulb 106 (or bulb of the aorta), and on
transverse section shows a somewhat oval figure. The ascending
aorta 102 is contained within the pericardium and is enclosed in a
tube of the serous pericardium. It ascends for a short distance
(the ascending aorta 102 is about 5 cm in length in an adult
human), arches backward, and then descends within the thorax and
abdomen (the descending aorta 108) and ends into the right and left
common iliac arteries (about 1.7 cm in diameter in an adult human).
The right coronary 110 and the left coronary 112, as shown in FIG.
1, branch from the ascending aorta 102.
[0045] There are three arteries that branch from the aortic arch
104, namely the innominate artery 114, the left common carotid
artery 116, and the left subclavian artery 118. Instead of arising
from the highest part of the aortic arch 104, these branches may
spring from the commencement of the aortic arch 104 or the upper
part of the ascending aorta 102. The distance between the aortic
arch 104 or the upper part of the ascending aorta 102 at their
origins may be increased or diminished, the most frequent variation
being the approximation of the left common carotid artery 116
toward the innominate artery 114. In addition, and as shown in FIG.
1, the innominate artery 114 branches into the right subclavian
artery 120 and the right common carotid artery 122.
[0046] Ischemic strokes, the most common type of stroke, occur when
blood clots or other debris are swept through the bloodstream and
lodge in one or more of the aortic branches 114, 116. As the
innominate and left common carotid arteries 114, 116 ultimately
supply blood to the brain, the partial or complete blockage thereof
reduces or inhibits blood flow to the brain, thus increasing the
risk of ischemic stroke. Ejection dynamics of blood clots from the
left ventricle is diverse and random, with clots having different
release velocities at different stages of the cardiac cycle.
Furthermore, blood clots can vary in size--typically in the range
of about 2 mm to about 6 mm--which can also have a significant
effect on clot velocity and their flow patterns as they leave the
heart. In addition, the hemodynamics in the aortic arch 104 are
typically characterized as complex flow patterns due to the arch
curvature and branches 114, 116. Accordingly, clot trajectory is a
complex function of aortic flow conditions, discrete phase behavior
of clots, and their dynamic interactions. To prevent ischemic
stroke, not only must clots be prevented from lodging within the
aortic branches 114, 116, but the solution must be mindful of the
complexity of the aortic flow field and not generate a substantial
resistance to flow therethrough.
[0047] The devices, systems, and methods of the present application
are configured to maintain a balance between efficacy in deflecting
blood clots from an artery extending from the aortic arch 104 and
affecting minimal influence on resistance to blood flow
therethrough. In this manner, such deflection devices, systems and
methods can ensure diversion of blood clots away from the aortic
branches 114, 116, rather than blocking clots on the device and
thereby obstructing the underlying arteries. FIGS. 2A-2C show
exemplary embodiments of a device of the present application for
the prevention of stroke. In application, such device (and any
embodiments thereof) may be used with one or more of the aortic
branches 114, 116, 118 to deflect the trajectory of blood clots
destined for the structures of the aorta 100 with negligible change
in blood flow resistance. As shown in FIG. 2A, an exemplary device
200 may comprise a stent comprising an extension portion 202 and a
flange portion 204. Extension portion 202, as shown in FIG. 2A, may
comprise a cylindrical stent sized and shaped to fit securely
within an aortic branch. An exemplary extension portion 202 may
comprise, for example, extension mesh 206 comprising multiple wires
as shown in FIG. 2A. Flange portion 204 may comprise an inner
diameter (shown as D1 in FIG. 2A) and an outer diameter (shown as
D2), whereby D2 is larger than D1. In at least one embodiment,
device 200 is collapsible, similar to a traditional stent.
Alternatively or additionally, the device 200 (or independent
components thereof) may be autoexpandable to facilitate secure
anchoring within an artery and/or the long term stability of the
device 200 after placement.
[0048] In at least one embodiment of device 200 of the disclosure
of the present application, device 200 comprises an autoexpandable
metallic stent comprising a proximal flange (flange portion 204)
and a distal cylindrical tube (extension portion 202). In an
exemplary embodiment, extension portion 202 is approximately 1.0 cm
to 2.5 cm in length. In at least one embodiment of device 200, the
diameter of the stent is approximately 6 to 8 mm. Suitable material
for a device 200 includes but is not limited to, stainless steel,
cobalt-chromium-nickel-molybdenum-iron alloy, tantalum, nitinol,
nickel-titanium, polymer materials, and various shape-memory
polymers known in the art, including polyurethane,
polytetrafluoroethylene or polytetrafluoroethene (PTFE), or another
synthetic material.
[0049] Flange portion 204, as shown in the exemplary embodiments
shown in FIGS. 2A and 2B, comprises flange mesh 208 comprising
multiple wires. In another embodiment, and as shown in FIG. 2C,
flange portion 204 comprises a planar flange 210 comprised of
metal, plastic, or any other material suitable for such a flange
portion 204. The flange portion 204 may comprise any length and/or
diameter that is effective to impede the progression of the device
200 within an artery when positioned within a body. In at least one
embodiment, the flange portion 204 is between about 3 mm and about
5 mm in length. Furthermore, the flange portion 204 may be
configured to move between a collapsed position having a smaller
diameter for delivery and/or retrieval of the device 200 (see FIG.
6A) and an expanded position having a larger diameter (see FIG.
2A). For example, in at least one embodiment, the flange portion
204 is comprised of an autoexpandable material such that when the
flange portion 204 is released from a delivery mechanism, it
automatically moves into the expanded position to assist in
anchoring the device 200 within an artery of interest. As shown in
FIGS. 2A-2C, the device 200 also comprises two or more convex
struts 212 operable to divert, for example, an embolus, from
entering the inner portion of device 200 (the inner portion defined
by extension portion 202) while still allowing blood to flow
therethrough without significantly affecting flow resistance.
Convex struts 212 are one example of such an embolus diversion
portion of device 200, noting that other embodiments of an embolus
diversion not comprising convex struts 212 may be useful with
device 200. For example, and instead of convex struts 212, an
exemplary embolus diversion portion may comprise a mesh (similar
to, for example, extension mesh 206 and/or flange mesh 208),
whereby such a mesh is operable to divert an embolus from entering
the inner portion of device 200.
[0050] Convex struts 212, in an exemplary embodiment, are
positioned along device 200 to cover the proximal orifice of the
cylindrical stent (device 200). In at least one embodiment of a
device 200 of the disclosure of the present application, the
diameter of each convex strut 212 is approximately 0.25 mm to 1.0
mm, and the distance between each convex strut 212 is approximately
0.75 mm to 1.0 mm. In at least one exemplary embodiment, the
diameter of each convex strut 212 is approximately 0.75 mm and the
distance between each convex strut 212 is approximately 0.75 mm,
which has been found to provide beneficial deflection efficacy with
respect to emboli while affecting only negligible change in flow
resistance through the underlying artery.
[0051] It will be appreciated that the number of convex struts 212
present on the device 200 may be customized according to a user's
preferences and/or patient specifications. Furthermore, each convex
strut 212 of the device 200 need not be configured identically;
indeed, device 200 may be configured to employ various combinations
of convex strut 212 diameter, intervals, and heights. Moreover, the
convex struts 212 may also comprise varying cross-sectional areas
and/or a non-spherical profile of the convex envelope. Convex
struts 212 may comprise material the same and/or similar to the
material used to prepare other portions of device 200, and may also
be a combination of a metal plus polyurethane,
polytetrafluoroethylene or polytetrafluoroethene (PTFE), or another
synthetic material.
[0052] In at least one embodiment, convex struts 212 may be
semi-rigid or flexible in order to allow the removal of a hypotube
402 (see FIGS. 6A-7B) and/or allow the passage of a catheter stent
device, including device 200, for stenting the carotid artery, for
example, if it develops an atherosclerotic plaque. In an exemplary
embodiment, the strut shape can be convex or semi-convex in order
to be easily and constantly "washed" by the aortic blood flow and
therefore avoid local thrombosis. If an embolus lands on a strut,
the strut shape will also allow it to wash off to the periphery not
only preventing the embolus from entering the brain vascular
system, but also deflecting the embolus away from the ostium of the
artery to ensure the blood flow therethrough does not become
restricted or blocked (i.e. the embolus does not stick to the
convex struts 212, but rather deflects off).
[0053] In addition, and in the exemplary embodiment shown in FIG.
2B, device 200 may further comprise one or more radiopaque markers
214 located proximally and/or distally on device 200 to aid the
placement of device 200 within a body. For example, in at least one
embodiment, one or more radiopaque markers 214 are positioned on
the flange portion 204 in a location(s) relative to the convex
struts 212 of the device 200. Accordingly, when the device 200 is
positioned within an artery, the one or more markers 214 on the
device 200 can be visualized to identify the orientation of the
convex struts 212 relative to the direction of the blood flow.
[0054] Now referring to FIGS. 3A-3C, an additional exemplary
embodiment of the device 200 is shown. As illustrated in FIG. 3A,
in this embodiment, instead of the mesh or planar flange portion
204, the device 200 comprises two or more wings 304 extending from
the extension portion 202. In at least one embodiment, each of the
wings 304 is defined by a wire 303. As shown in FIG. 3A, for
example, each wing 304 (or wire 303 of each wing 304) extends from
a second end 292 of extension portion 202, noting that extension
portions 202 referenced herein have a first end 290 (as shown in
FIG. 3A, for example) configured to extend within a vessel, and a
second end 292 at the location of the various struts 212 and/or
wings 304. Each wing 304 of the plurality of wings 304, for
example, may comprise a wire 303 forming a loop relative to the
second end 292 of the extension portion 202. The plane of each wing
304 may be left as an open space (as shown in FIGS. 3A-3C), or
covered by a mesh or any other suitable material. When the
embodiment of the device 200 having two or more wings 304 is
positioned within a body, the wings 304 contact the underlying
tissue at intervals, thereby utilizing a minimized structure to
hold the device 200 in place as compared to the device 200
comprising the flange portion 204.
[0055] Similar to the flange portion 204, wings 304 of the device
200 are sized and configured to impede the progression of the
device 200 within an artery when positioned within a body.
Additionally, when the device 200 is placed within a proximal
opening of the innominate artery 114 or the left common carotid
artery 116, the wings 304 may further provide a support structure
over the aortic wall of the aortic arch 104 at the entrance of the
supra-aortic branches 114, 116. The wings 304 may be between about
3 mm and about 5 mm in length. As shown in FIGS. 3A-3C, wings 304
may comprise a petal configuration; however, it will be noted that
any suitable shape or configuration any be employed and that each
wing 304 of the device 200 need not have the same length and/or
configuration. In addition, in the exemplary embodiment shown in
FIG. 3C, the wings 304 of the device 200 may further comprise one
or more radiopaque markers 214.
[0056] Similar to the flange portion 204, the wings 304 are
configured to move between a collapsed position having a smaller
overall diameter (see FIG. 6B) and an expanded position having a
larger overall diameter D (see FIG. 3B). In at least one
embodiment, each of the wings 304 are hingedly coupled with the
extension portion 202 and biased to the expanded position. As such,
when the wings 304 are not held in the collapsed position, the
wings 304 automatically move to the expanded position. As described
in further detail herein, movement of the wings 304 between the
collapsed and expanded positions facilitates delivery/retrieval and
the long term stability of the device 200 within an artery.
[0057] FIG. 4 shows yet another exemplary embodiment of the device
200. As illustrated in FIG. 4, the extension portion 202 of the
device 200 may alternatively comprise a stent frame 310 without the
inclusion of extension mesh or other materials thereon. In this
embodiment of the device 200, the extension portion 202 has
significantly less structure than the embodiment shown in FIG. 2A.
As with the previously described embodiments, the stent frame 310
may comprise an autoexpandable metallic stent capable of radial
expansion such that, when deployed within an artery, the stent
frame 310 anchors the device 200 therein by way of radial force.
While the embodiment of FIG. 4 comprises wings 304, it will be
appreciated that a device 200 comprising the stent frame 310 may
alternatively comprise the flange portion 204 or any other
component described herein. Exemplary stent frames 310, such as
shown in FIG. 4, may comprise a plurality of extension struts 311
positioned around a relative perimeter or circumference of device
200 (such as around the opening where convex struts 212 are
located), extending from second end 292 toward first end 290, and
may be connected to one another using one or more connection struts
313, which may be curved as desired as shown in FIG. 4.
[0058] Exemplary devices for the prevention of stroke positioned
within a portion of an aorta are shown in FIGS. 5A and 5B. While
the devices 200 illustrated in FIGS. 5A and 5B both comprise a
flange portion 204 and an extension portion 202 having extension
mesh 206, it will be understood that any embodiments of the device
200 of the present disclosure can be positioned pursuant to and are
capable of the same functionality described in connection with
FIGS. 5A and 5B.
[0059] As shown in FIGS. 5A and 5B, two devices 200 are positioned
within arteries branching from aorta 100, with one device 200
positioned partially within innominate artery 114 and another
device 200 positioned partially within left common carotid artery
116. Device 200 within innominate artery 114 is positioned such
that extension portion 202 is positioned within a portion of
innominate artery 114 extending from aortic arch 104 and flange
portion 204 prevents device 200 from advancing further into
innominate artery 114. Similarly, a device 200 is shown in FIGS. 5A
and 5B positioned within left common carotid artery 116 such that
extension portion 202 is located within a portion of left common
carotid artery 116 extending from aortic arch 104 and flange
portion 204 prevents device 200 from advancing further into left
common carotid artery 116. In at least one embodiment, flange
portion 204 completely covers and exceeds the size of the entrance
of the artery in which device 200 is positioned. In an exemplary
embodiment of device 200 positioned within an artery as referenced
herein, the distal cylindrical portion of the stent (extension
portion 202 of device 200) additionally or alternatively anchors
device 200 by applying radial force to the arterial walls of the
artery in which device 200 is placed. In this manner, both the
extension portion 202 and the flange portion 204 may act to anchor
the device 200 in place when positioned within an artery.
[0060] As shown in the exemplary embodiments of device 200 shown in
FIG. 5A, convex struts 212 are aligned in a direction similar to
the flow of blood within aorta 100. In such an alignment, and as
blood flows through aorta 100, an embolus 300 present within aorta
100 (specifically within the aortic arch 104) would be guided by
the blood flow along convex struts 212 and across the proximal
opening of the aortic branch. As shown in FIG. 5B, the convex
struts 212 of both devices 200 are aligned in a direction
approximately perpendicular to the flow of blood within aorta 100.
In such an alignment, an embolus 300 present within aorta 100 would
contact convex struts 212 and be deflected therefrom with little or
no risk of embolus 300 being trapped therein. As referenced herein,
convex struts 212 may also be positioned in the direction of (i.e.,
approximately parallel with), or in an oblique manner relative to,
blood flow within the aortic arch 104 as shown in FIG. 5A. In
application, the device 200 may be positioned within an artery to
achieve any orientation of the convex struts 212 relative to the
flow field that may be desired in accordance with patient
specifications and/or user preference.
[0061] Positioning the devices 200 as shown in FIGS. 5A and 5B
prevents an embolus 300 from entering the innominate artery 114 and
the left common carotid artery 116, but allows the embolus 300 to
enter the left subclavian artery 118. Because the innominate and
left common carotid arteries 114, 116 supply blood flow to the
brain, in this example, the devices 200 thus prohibit the embolus
300 from advancing to the brain vascular system, thereby
significantly reducing a patient's risk of ischemic stroke.
Instead, the embolus 300 is allowed to flow into other
arteries--such as the femoral or iliac arteries, for example--where
such embolus 300 can be filtered from or sucked out of the blood
stream using an appropriate medical procedure. In other words, such
an arrangement of devices 200 may effectively prevent a patient
from having a stroke by deflecting any embolus 300 present in the
blood stream away from the vessels that feed the brain and instead
routing such emboli 300 to a location where they may be easily and
safely removed.
[0062] In summary, and as described above with respect to FIGS. 5A
and 5B, for example, the present disclosure provides a device 200,
which may be referred to as a percutaneous carotid emboli rerouting
device, configured for individual delivery to an artery given off
by the aortic arch 104 (namely the innominate artery 114, the left
common carotid artery 116, and the left subclavian artery 118) to
avoid the passage of embolic or thromboembolic material (an embolus
300, which may be, for example, a clot, calcium, etc.) to the brain
vascular system. Furthermore, the present disclosure provides for
the provision of more than one of these devices 200 to the arteries
off the aortic arch 104 such that an arrangement of devices 200
prevents thromboembolic stroke in patients with different
cardiovascular diseases from cardiac origin.
[0063] At least one goal of the devices, systems, and methods of
the present disclosure is to reroute an embolus distally to the
arterial system (iliac or femoral arteries) to avoid disabling
stroke, decrease mortality and avoid physical impairment with a
poor quality of life. As previously mentioned, unlike stroke,
medical or surgical treatment of the peripheral arterial embolus
(fibrinolitic drugs, surgical embolectomy, or endovascular embolus
suction) can be provided with little residual effect. This may be
particularly useful to patients who have undergone medical
procedures associated with a high risk of stroke and/or blood clots
being released following the procedures (e.g, transcatheter aortic
valve implantation ("TAVI"), mitral valve replacement, calcific
mitral valve insufficiency, balloon dilation, etc.). For example,
the general risk of stroke after TAVI is about three percent (3%),
which increases to about six to ten percent (6-10%) thirty days
following the procedure, and again to about seventeen to
twenty-four percent (17-24%) one year following the procedure. As
such, while TAVI (or similar procedures) is often used to repair a
patient's heart and/or circulatory system, the procedure often
results in brain damage due to its side-effect of increasing the
occurrence of blood clots.
[0064] The devices, systems and methods of the present disclosure
can be used in connection with such patients to divert the
resulting clots. Moreover, the devices, systems and methods
described herein are also particularly applicable to patients who
cannot receive anticoagulants, are prone to clots forming in the
left atrial appendage and entering the bloodstream, or simply
present an elevated risk for brain damage due to stroke. The risk
of brain damage can also generally be reduced with the elderly by
employing the devices, systems and methods disclosed herein.
[0065] Exemplary embodiments of a system for preventing stroke of
the present disclosure is shown in FIGS. 6A and 6B. As shown in
FIGS. 6A and 6B, system 400 comprises a hypotube 402 having a
distal end and a proximal end, and in at least one exemplary
embodiment, hypotube 402 comprises a folder 404 coupled to the
distal end of hypotube 402. In the embodiment shown in FIG. 6A,
system 400 further comprises a device 200, whereby an extension
portion 202 of device 200 is shown positioned within at least part
of folder 404 and a flange portion 204 of device 200 is positioned
within at least part of a sleeve 406 and around hypotube 402
proximally of folder 404. Sleeve 406, as shown in this exemplary
embodiment, slidingly engages hypotube 402 and may be moved in a
forward or backward direction as indicated by the arrow in the
figure. FIG. 6B illustrates an embodiment of system 400 where,
instead of having the flange portion 204, the device 200 comprises
two or more wings 304. Accordingly, in FIG. 6B, the wings 304 of
the device 200 are shown in the collapsed position positioned
within at least part of a sleeve 406 and around hypotube 402
proximal to folder 404.
[0066] In at least one embodiment, device 200 is an autoexpandable
metallic stent mounted over a hypotube 402 as shown in FIGS. 6A and
6B. Device 200 may be compressed by sleeve 406 and folder 404 such
that both the extension portion 202 and the flange portion 204 or
the wings 304 (as applicable) are in their collapsed positions. In
at least one embodiment, at least part of system 400 has a diameter
of 7 Fr to 8 Fr (2.3 to 2.7 mm), with an exemplary device 200
having a compressed diameter of about 1.8 to 2.0 mm.
[0067] FIGS. 7A and 7B show exemplary embodiments of at least
portions of systems for preventing stroke of the present
disclosure. While FIGS. 7A and 7B illustrate an embodiment of the
device 200 comprising flange portion 204, it will be understood
that this disclosure is equally applicable to any embodiment of the
device 200 disclosed herein (including, but not limited to, device
200 comprising wings 304).
[0068] As shown in FIG. 7A, an exemplary system 400 comprises
hypotube 402 to which folder 404 is coupled thereto. System 400, as
shown in FIGS. 7A and 7B, further comprises sleeve 406 slidingly
engaged around hypotube 402. Device 200 may be positioned at least
partially within folder 404 and sleeve 406 prior to deployment,
whereby the extension portion 202 of device 200 may be positioned
within at least part of folder 404 in a collapsed position, and
whereby the proximal portion (i.e. the flange portion 204 or wings
304, as applicable) of device 200 may be positioned within at least
part of a sleeve 406 in a collapsed position (as shown in FIGS. 6A
and 6B).
[0069] As shown in FIG. 7A, device 200 may be partially deployed as
follows. First, and in an exemplary method of positioning a stent
within a body, a wire 500 (a guide wire, for example) may be
advanced within a body at or near a desired location of device 200
deployment. When wire 500 has been advanced, hypotube 402, along
with any portions of system 400 coupled to hypotube 402, may be
advanced along wire 500 within the body. As shown in FIGS. 7A and
7B, initial advancement of at least a portion of system 400 may
comprise advancement of hypotube 402, folder 404, sleeve 406, and
device 200 positioned within folder 404 and sleeve 406.
[0070] When device 200 has been positioned within a body at or near
a desired position, sleeve 406 may be withdrawn toward the proximal
end of hypotube 402 (in the direction of the arrow shown in the
figure). This step may be performed prior to, during, or after the
step of positioning the distal end of hypotube 402 within a vessel
(for example, a vessel branching off the aortic arch 104). As
sleeve 406 is slid toward the proximal end of hypotube 402, the
flange portion 204 of device 200 is allowed to expand as shown in
FIG. 7A Likewise, in the at least one embodiment where the device
200 comprises two or more wings 304, sliding the sleeve 406 toward
the proximal end of the hypotube 402 results in the wings 304
moving to the expanded position shown in FIGS. 3A-3C. While at this
step the flange portion 204/wings 304 are deployed, the extension
portion 202 remains within the folder 404. Accordingly, the
extension portion 202 remains undeployed and does not yet engage or
anchor to an arterial wall.
[0071] Further deployment of device 200 within a body is shown in
FIG. 7B. As shown in FIG. 7B, and upon movement of folder 404 away
from device 200 (in a direction shown by the arrow in the figure,
for example), extension portion 202 of device 200 may deploy as
shown in FIG. 7B. As folder 404 is moved away from device 200 (by,
for example, advancement of hypotube 402 within a body), extension
portion 202 of device 200 is no longer positioned within folder
404, thereby permitting expansion/deployment of extension portion
202.
[0072] FIGS. 8A and 8B show exemplary embodiments of at least a
portion of a system for preventing stroke. In at least one
embodiment, system 400 comprises a conical dilator 600 slidingly
engaged around a hypotube 402 coupled to a folder 404. As shown in
FIG. 8A, an exemplary conical dilator 600 may comprise a tapered
distal end 602, wherein the tapered distal end 602 is sized and
shaped to engage the inside of folder 404. To engage folder 404,
conical dilator 600 may slide along hypotube 402 in a direction
indicated by the arrow in FIG. 8A. An exemplary embodiment of the
engagement of conical dilator 600 and folder 404 is shown in FIG.
8B.
[0073] Engagement of conical dilator 600 with folder 404, as shown
in FIGS. 8A and 8B, may facilitate the removal of at least a
portion of system 400 from a body after positioning device 200. For
example, and as shown in FIGS. 7A and 7B, after deployment of
device 200 within a body, the portion of system 400 comprising
folder 404 is positioned, for example, further within a vessel than
device 200. Removal of the portion of the system 400 comprising
hypotube 402 and folder 404 would require, for example, pulling
that portion of system 400 back through device 200. As shown in the
exemplary embodiments of FIGS. 7A-8B, folder 404 may, for example,
become caught on device 200 and/or a portion of a body, preventing
effective removal of that portion of system 400.
[0074] In at least one embodiment, and by engaging folder 404 with
conical dilator 600, folder 404, along with the portion of system
400 coupled to folder 404, may be removed from a body after
placement of a device 200 as shown in FIGS. 9A and 9B. As shown in
FIG. 9A, and after a device 200 has been deployed, a user of system
400 may slide a conical dilator 600 along hypotube 402 in a
direction indicated by the arrow. Conical dilator 600, in the
example shown in FIGS. 9A and 9B, is sized and shaped to fit within
the spaces between convex struts 212 of device 200. After conical
dilator 600 has engaged folder 404, as shown in FIG. 9B, when
hypotube 402 is withdrawn from the body in a direction indicated by
the arrow, folder 404 is also removed from the body without
becoming caught on device 200.
[0075] In at least one embodiment of a system for preventing stroke
of the present disclosure, system 400 comprises a device 200, a
hypotube 402, and a folder 404 coupled to hypotube 402 at or near
the distal end of hypotube 402. Device 200, in at least one
embodiment, may be autoexpandable, i.e. device 200 has a "memory"
allowing it to expand to a native configuration after being
retracted/compressed to fit within, for example, folder 404 and
sleeve 406. System 400, in at least one embodiment, may further
comprise, or be used in connection with, a femoral catheterization
kit known and used in the marketplace.
[0076] Now referring to FIG. 14, at least one method of preventing
stroke will now be described using the components of the previously
described systems for reference and explanatory purposes.
Primarily, at step 1402, the device 200 is positioned within a
body. In at least one exemplary embodiment of the present
disclosure, the percutaneous placement of the percutaneous carotid
emboli rerouting device (device 200) may be performed in an
angiography procedure room. Prior to positioning device 200 at step
1402, a user may optionally perform a contrast aortogram, for
example, to map out the aortic arch 104 and where the cerebral
vessels merge with aortic arch 104 (optional step 1401). For
safety, patient preparation and sterile precautions are recommended
as for any angioplasty procedure.
[0077] In at least one embodiment of the method 1400 for preventing
stroke, the optional step 1401 of the method 1400 additionally or
alternatively comprises performing a percutaneous angiogram using
technique(s) known in the art under local anesthesia. As referenced
above, the percutaneous angiogram maps the aortic arch 104 so that
a user of a device 200 and/or system 400 of the present disclosure
can, for example, select an appropriately-sized device 200 and/or
system 400 (or portion(s) thereof) when performing the
procedure.
[0078] At step 1402, to facilitate positioning the device 200
within a body, a user may introduce a wire 500 (such as guide wire
as shown in FIG. 7A) to reach the innominate artery 114 and/or the
left common carotid artery 116. After wire 500 has been positioned,
portions of system 400 may be mounted over the guide wire 500 and
progressed to the level of the entrance of the innominate artery
114 and/or the left common carotid artery 116. Said portions of
system 400 may include hypotube 402 and a folder 404 distally
mounted thereto, and may further comprise a sleeve 406, wherein an
exemplary device 200 may be positioned at least partially within
folder 404 and sleeve 406, as shown in FIG. 10A. After the
device(s) 200 are properly positioned at step 1402, the method 1400
advances to step 1404 where the device(s) 200 are deployed.
[0079] Deployment of device 200 at step 1404, in an exemplary
embodiment of a method of the present application for performing
the same, is as a follows. Under fluoroscopy, sleeve 406 may be
pulled back to allow the delivery of the proximal portion of the
stent (the flange portion 204 or wings 304 of device 200) as shown
in FIG. 10B. The diameter of flange portion 204 or wings 304 that
exceeds the diameter of the innominate artery 114 and/or the left
common carotid artery 116 impedes the progression of device 200
within said arteries, thus giving the user/operator time to deliver
and anchor the second portion of the stent (the extension portion
202 of device 200) by, for example, forward progression of hypotube
402 as shown in FIGS. 7B and 10C. In addition to preventing the
device 200 from progressing within the artery, when the flange
portion 204 and/or wings 304 are expanded upon delivery to the
artery of interest, such structures also provide support over the
aortic wall of the aortic arch 104 at the level of proximal aortic
ostium in which the device 200 is deployed.
[0080] In at least one embodiment, deployment of the device 200 at
step 1404 may be facilitated through the use of radiopaque markers
214. Where the device 200 comprises radiopaque markers 214, prior
to anchoring the extension portion 202 of the device 200, such
markers 214 can be used to assist with ensuring proper alignment.
Specifically, the user/operator can visualize the radiopaque
markers 214 through fluoroscopy or other technology and rotate the
device 200 accordingly so that the convex struts 212 are positioned
as desired relative to the direction of blood flow within the
aortic arch 104. In this manner, the radiopaque markers 214 can
facilitate placement and orientation of the device 200. In various
embodiments, device 200 can be positioned approximately
perpendicular to, or in a direction of (i.e. approximately parallel
with), or in an oblique manner relative to, blood flow in the
aortic arch 104, and can even be positioned/deployed in an oblique
manner (not parallel or perpendicular), should such a deployment be
desired.
[0081] When device 200 has been positioned at step 1402 and
deployed at step 1404, the method 1400 may advance to step 1406
where the hypotube 402 and folder 404 are removed from the body,
for example, by introducing conical dilator 600 as described
herein. In at least one example, the tapered distal end 602 of
conical dilator 600 is advanced until it engages folder 404 of
hypotube 402, as shown in FIGS. 8A-9B, 10D and 10E, effectively
forming a single unit (conical dilator 600+hypotube 402+optionally
wire 500 (not shown)). This "unit" may then removed through the
convex struts 212 as shown in FIG. 10E, and distally to the femoral
artery for which at least part of system 400 was initially
introduced.
[0082] Now referring to FIGS. 11-13B, an exemplary system 700 for
preventing stroke of the present disclosure is shown. At times,
temporary placement of the devices 200 disclosed herein may be
desired (as opposed to chronic or permanent placement). In such
cases, it is necessary to retrieve the device 200 from the patient
after a prescribed period of time has elapsed or other indications
are observed. System 700 comprises a retrieval system for use in
retrieving one or more devices 200 previously positioned within an
artery extending from the aortic arch 104.
[0083] System 700 comprises a sleeve catheter 702, a retrieval
device 704, and at least one device 200. The sleeve catheter 702 is
configured for intravascular insertion and advancement, and
comprises an open distal end 708, a proximal end 710 (see FIG.
11C), and a lumen 712 extending therebetween. The retrieval device
704 is slidably disposed within the lumen 712 of the sleeve
catheter 702 and comprises a proximal end (not shown) for
manipulation by a user/operator and a distal end 706 configured for
advancement through the open distal end 708 of the sleeve catheter
702. The distal end 706 of the retrieval device 704 further
comprises one or more attachment portions 714 positioned thereon,
each of which are configured to engage the at least one device
200.
[0084] The retrieval device 704 may comprise any configuration
suitable for slidably advancing through the lumen 712 and through
the open distal end 708 of the sleeve catheter 702. It will be
appreciated that the specific configuration of the retrieval device
704 and its one or more attachment portions 714 can be selected
and/or adapted to correspond with the configuration of the
device(s) 200 to be retrieved. For example, in the embodiments
shown in FIGS. 11A-12, the retrieval device 704 is configured to
retrieve a device 200 comprising two or more wings 304 and, thus,
comprises one or more wires. Alternatively, in the embodiment of
FIGS. 13A and 13B, the retrieval device 704 comprises an elongated
catheter having one or more attachment portions 714 configured to
engage either the wings 304 or the flange portion 204 (as
applicable) of the device 200. Furthermore, the proximal portion
(the wings 304 or the flange portion 204, as applicable) of the
device 200 may be additionally configured to engage or receive the
attachment portion(s) 714 of the retrieval device 704.
[0085] Now referring back to FIGS. 11A-11C, an embodiment of a
system 700 for retrieving at least one device 200 having two or
more wings 304 is shown. This embodiment of the system 700 has a
retrieval device 704 comprising one or more wires slidably disposed
within the lumen 712 of the sleeve catheter 702. Each of the wires
of the retrieval device 704 of this embodiment comprises an
attachment portion 714 configured to securely grab at least one of
the wings 304 of the device 200. For example, an attachment portion
714 may be curved or comprise a hook capable of grabbing one of the
wings 304 of the device 200. Alternatively, the attachment portion
714 may comprise a screw shape or any other configuration capable
of securely grabbing at least one of the wings 304 of the device
200.
[0086] While the number of wires of the retrieval device 704 may
correspond with the number of wings 304 present on the device(s)
200 to be retrieved, it will be recognized that the retrieval
device 704 may comprise any number of wires. For example, in the
event the retrieval device 704 comprises more wires than the number
of wings 304 present on the device(s) 200 to be retrieved, more
than one wire may be attached to a single wing 304 and/or any extra
wires may remain unattached. Conversely, in the event the retrieval
device 704 comprises fewer wires than the number of wings 304
present on the device(s) 200 to be retrieved, the available wires
may be strategically attached to the wings 304 such that a
sufficient amount of force can be exerted on each device 200 to
move it to the collapsed position and thus disengage the device 200
from the aortic and arterial walls.
[0087] FIG. 12 shows the system 700 as applied to two devices 200
positioned within the innominate artery 114 and the left common
carotid artery 116, respectively. In this embodiment, each of the
devices 200 comprises three wings 304 and the retrieval device 704
comprises six attachment portions 714 (here, shown as wires). As
such, each wire of the retrieval device 704 corresponds with and is
attached to one wing 304 of a device 200. It will be appreciated
that a user/operator can manipulate the wires as a whole (thus
manipulating both devices 200 concurrently) or, alternatively,
manipulate the two devices 200 independently by identifying and
maneuvering only those select wires that correspond with each
independent device 200.
[0088] While FIGS. 11A-12 illustrate embodiments of the system 700
comprising a retrieval device 704 having wires, the retrieval
device 704 of the system 700 may comprise any configuration
suitable for slidably advancing through the lumen 712 and the open,
distal end 708 of the sleeve catheter 702. Furthermore, the
configuration of the one or more attachment portions 714 of the
retrieval device 704 can be selected and/or adapted to correspond
with the configuration of the device 200 to be retrieved. FIGS. 13A
and 13B show two non-limiting examples of such alternative
embodiments of a retrieval device 704. In these embodiments, the
retrieval device 704 comprises an elongated catheter having an
attachment portion 714 on or near its distal-most end. Likewise,
the proximal portion (flange portion 204 or wings 304, as
applicable) of the device 200 may be configured to correspond with
the attachment portion 714 of the retrieval device 704. For
example, in the embodiment shown in FIG. 13A, the attachment
portion 714 of the retrieval device 704 defines a cavity having
female threads disposed therein and a magnet 716, while the flange
portion 204 of the device 200 comprises a corresponding portion 718
having male screw threads and a magnet. Similarly, FIG. 13B shows
an embodiment where the attachment portion 714 of the retrieval
device 704 comprises a lace and the corresponding portion 718 of
the flange portion 204 comprises a corresponding hook tip.
Accordingly, in each of the aforementioned embodiments, the device
200 may be easily engaged by the attachment portion 714 of the
retrieval device 704.
[0089] After the attachment portion 714 of the retrieval device 704
is securely coupled with the device 200 (via the corresponding
portion 718 or otherwise), a user/operator can manipulate the
proximal end (not shown) of the retrieval device 704 and thus
manipulate the device 200. In this manner, a user/operation may
move a device 200 positioned within an artery extending from the
aortic arch 104 to its collapsed position and, thus, disengage the
device 200 from the aortic and arterial walls.
[0090] In the embodiments shown in FIGS. 11A-11C, moving the device
200 from the expanded/anchored position to the collapsed/disengaged
position is accomplished by pulling the distal end/attachment
portion 714 of the retrieval device 704 toward the proximal end 710
of the sleeve catheter 702, thereby applying pressure to the device
200 in the direction of the arrow shown in FIG. 11B. Due to the
configuration of the wires of the retrieval device 704, moving the
retrieval device 704 in a proximal direction applies pressure to
the wings 304 and pulls them from the expanded position to the
collapsed position. As the wings 304 are coupled with the extension
portion 202 of the device 200, this motion translates to the
extension portion 202 as well, thereby causing the entire device
200 to move to a collapsed position and disengage the aortic and
arterial walls. After the device 200 is disengaged, the retrieval
device 704 (and thus the collapsed device 200) is then slidably
removed from the sleeve catheter 702 and the patient's body.
[0091] The various devices, systems, and methods for preventing
stroke of the present disclosure have various benefits to patients
with various diseases and/or disorders of the heart and/or
circulatory system. For example, patients with chronic atrial
fibrillation (non-valvular atrial fibrillation), recurrence
transient ischemic attack, atrial fibrillation and anticoagulation
contraindications, and/or left atrial appendage thrombosis may have
their risk of stroke either reduced or eliminated by way of an
exemplary devices, systems, and/or method of the present
disclosure. In addition, patients with acute myocardial infarct
with left ventricular thrombus, atrial flutter (ablation and
pulmonary vein isolation), cardiomyopathy with left ventricular
enlargement, non-obstructive thrombus of a mechanical heart valve,
patent foramen ovale (cryptogenic ischemic stroke) and/or an acute
infection endocardiatis with valve vegetation without valve
insufficiency under medical treatment (vegetation >1 cm which
currently oblige to surgical remotion) may also benefit from the
present disclosure.
[0092] Furthermore, it is noted that the various devices, systems,
and methods for preventing stroke of the present disclosure have
advantages as compared to anticoagulant and antiplatelet therapies,
as not all patients are suitable for such therapies (given the high
risk of bleeding, for example), and the relative cost of such
therapies, which would be substantially higher as compared to the
devices and systems as referenced herein. The various devices and
systems would be useful for various aortic arch configurations,
noting that there is diversity among arches.
[0093] While various embodiments of devices, systems, and methods
for the prevention of stroke have been described in considerable
detail herein, the embodiments are merely offered by way of
non-limiting examples of the disclosure described herein. It will
therefore be understood that various changes and modifications may
be made, and equivalents may be substituted for elements thereof,
without departing from the scope of the disclosure. Indeed, this
disclosure is not intended to be exhaustive or to limit the scope
of the disclosure.
[0094] Further, in describing representative embodiments, the
disclosure may have presented a method and/or process as a
particular sequence of steps. However, to the extent that the
method or process does not rely on the particular order of steps
set forth herein, the method or process should not be limited to
the particular sequence of steps described. Other sequences of
steps may be possible. Therefore, the particular order of the steps
disclosed herein should not be construed as limitations of the
present disclosure. In addition, disclosure directed to a method
and/or process should not be limited to the performance of their
steps in the order written. Such sequences may be varied and still
remain within the scope of the present disclosure.
* * * * *