U.S. patent application number 11/039908 was filed with the patent office on 2005-06-16 for endovascular aneurysm treatment device and method.
This patent application is currently assigned to University of Louisville Research Foundation. Invention is credited to Abdel-Gawwad, Hesham M..
Application Number | 20050131443 11/039908 |
Document ID | / |
Family ID | 26918648 |
Filed Date | 2005-06-16 |
United States Patent
Application |
20050131443 |
Kind Code |
A1 |
Abdel-Gawwad, Hesham M. |
June 16, 2005 |
Endovascular aneurysm treatment device and method
Abstract
An self-expanding frame is mounted on the distal end of a shaft.
The frame is sized and configured so that it can be inserted into
the cavity of an aneurysm. Suction is applied to the interior of
the aneurysm through the shaft or through another catheter, and the
wall of the aneurysm is collapsed onto the exterior surface of the
frame. The frame is then collapsed upon further suction being
applied to the interior of the aneurysm, which collapses the
aneurysm wall with it. The frame folds down on itself, carrying
with it the aneurysm wall. The frame is detachable from the shaft
and can be left in the collapsed aneurysm.
Inventors: |
Abdel-Gawwad, Hesham M.;
(Louisville, KY) |
Correspondence
Address: |
BURNS DOANE SWECKER & MATHIS L L P
POST OFFICE BOX 1404
ALEXANDRIA
VA
22313-1404
US
|
Assignee: |
University of Louisville Research
Foundation
Louisville
KY
|
Family ID: |
26918648 |
Appl. No.: |
11/039908 |
Filed: |
January 24, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11039908 |
Jan 24, 2005 |
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09925433 |
Aug 10, 2001 |
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6855154 |
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60224361 |
Aug 11, 2000 |
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Current U.S.
Class: |
606/191 |
Current CPC
Class: |
A61M 25/007 20130101;
A61M 2025/0037 20130101; A61M 25/0147 20130101; A61M 25/10
20130101; A61B 17/122 20130101; A61M 2025/0076 20130101; A61B
17/12136 20130101; A61M 2025/0681 20130101; A61B 17/12113 20130101;
A61B 2017/1205 20130101; A61B 17/12022 20130101; A61M 2025/1079
20130101; A61M 25/0082 20130101; A61M 25/0074 20130101; A61M
2025/0078 20130101; A61M 2025/0063 20130101; A61B 17/12172
20130101; A61M 25/003 20130101; A61B 2017/22051 20130101 |
Class at
Publication: |
606/191 |
International
Class: |
A61M 029/00 |
Claims
1. A system useful for treating an aneurysm in a blood vessel of a
mammalian patient, the aneurysm having a neck, a wall, and a
cavity, comprising: an elongated catheter having a proximal end, a
distal end, and including at least one lumen extending
therethrough; a telescoping stretching rod positioned in the
catheter; at least one steering pull wire extending distally
through the catheter and attached adjacent to the distal end of the
catheter; an inflatable member positioned adjacent the catheter
distal end; a one-way valve positioned adjacent the catheter distal
end and in fluid communication with the at least one lumen, the
one-way valve oriented to permit fluid flow into the catheter
lumen; an expandable clip releasably attached to the catheter
distal end, the expandable clip having an unbiased, expanded
condition and a biased, collapsed condition; wherein when the
expandable clip is positioned inside the cavity of an aneurysm and
expands, when the inflatable member is inflated to substantially
seal the neck of the aneurysm from the blood vessel, and when
suction is applied through the catheter lumen and through the
one-way valve, the aneurysm wall at least partially collapses on
the expanded clip.
2. A system in accordance with claim 1, further comprising: a
flexible spring positioned adjacent the catheter distal end, the
spring including a distal end, at least one steering pull wire
attached to the catheter adjacent to the spring distal end.
3-7. (canceled)
8. A catheter useful for accessing a vascular location adjacent to
an aneurysm, comprising: a hollow shaft including a proximal end, a
distal end, a longitudinal direction defined between the proximal
end and the distal end, a port in a distal portion of the shaft,
and including at least one lumen extending therethrough; an
inflatable member mounted on the shaft adjacent to the shaft distal
end, the inflatable member in fluid communication with the shaft at
least one lumen, the inflatable member including a proximal end, a
distal end, and a wall between the proximal end and the distal end
which extends to the shaft so that the shaft port is directly
exposed to the exterior of the balloon, the wall delimiting a
central working channel.
9. A catheter in accordance with claim 8, further comprising: a
longitudinally movable steering wire extending along the shaft; and
a deflectable tube mounted at the shaft port, the steering wire
attached to the deflectable tube so that when the steering wire is
pulled proximally, the deflectable tube deflects laterally.
10. A catheter in accordance with claim 8, further comprising: a
suction port on a distal portion of the shaft directly exposed to
the exterior of the balloon; and a suction lumen extending through
the shaft from the shaft proximal end to the suction port.
11. A catheter in accordance with claim 8, further comprising: at
least one radiopaque marker mounted immediately adjacent to the
central working channel.
12. A method of treating an aneurysm in a patient comprising the
steps of: advancing a compressed clip through the distal end of a
catheter and into the aneurysm; expanding portions of the clip
inside the aneurysm; folding a distal segment of the clip on itself
together with the adjacent wall of the aneurysm as it becomes
dislodged from the stretching bar.
13. A method in accordance with claim 12, further comprising
verifying complete occlusion of the neck by injection of contrast
agent through multiple side holes just proximal to the balloon and
simultaneously applied suction through the one-way valve at the
distal end of the catheter until no inflow of the contrast is
demonstrated together with deformation of the aneurysm with
suction, indicating that the aneurysm neck is completely
closed.
14. A method in accordance with claim 13, further comprising
continuing suction with the aneurysm neck completely closed to
almost completely collapse the aneurysm by creating a vacuum within
the aneurysm.
15. A method in accordance with claim 12, further comprising
measuring transverse and longitudinal dimensions of the
aneurysm.
16. A method in accordance with claim 13, further comprising
maintaining vacuum within the aneurysm with continuous suction and
adhering the aneurysm wall to sides of the clip.
17. A method in accordance with claim 16, further comprising
repeating the pulling step until successive segments fold and
complete collapse of the aneurysm is achieved.
18. A method in accordance with claim 12, further comprising
performing a road-mapping arteriogram with measurement of the three
dimensional size of the aneurysm and its neck.
19. A method in accordance with claim 12, further comprising
accessing the aneurysm neck using a steerable catheter.
20. A method in accordance with claim 19, further comprising
locking the distal end of the catheter in a position perpendicular
to the center of the neck transverse axis.
21. A method in accordance with claim 12, further comprising
inflating a balloon mounted on the distal end of a catheter with a
diluted contrast to the previously measured size of the neck.
22. A method in accordance with claim 12, further comprising:
pulling a stretching bar to telescope a very distal segment of the
stretching bar into the next proximal segment of the stretching
bar.
23. A system useful for treating an aneurysm in a blood vessel of a
mammalian patient, the aneurysm having a neck, a wall, and a
cavity, comprising: an elongated shaft having a proximal end, a
distal end, a longitudinal direction defined between the proximal
end and the distal end, and including at least one lumen extending
therethrough; a self-expanding frame positioned at the distal end
of the shaft, the frame including a plurality of self-expanding
sections disposed in the longitudinal direction, each of said
self-expanding sections being connected to an adjacent
self-expanding section via a separate joint, each of the plurality
of self-expanding sections having an unbiased, expanded condition
and a biased, collapsed condition, each of the plurality of
self-expanding sections being foldable in the longitudinal
direction and about the separate joint when in a biased, collapsed
condition, wherein the at least one joint being oriented
longitudinally when the plurality of self-expanding sections are in
the unbiased, expanded condition.
24. A system useful for treating an aneurysm in a blood vessel of a
mammalian patient, the aneurysm having a neck, a wall, and a
cavity, comprising: an elongated shaft having a proximal end, a
distal end, a longitudinal direction defined between the proximal
end and the distal end, and including at least one lumen extending
therethrough; a self-expanding frame positioned at the distal end
of the shaft, the frame including a plurality of self-expanding
sections disposed in the longitudinal direction, each of said
self-expanding sections being connected to an adjacent
self-expanding section via a separate joint, each of the plurality
of self-expanding sections having an unbiased, expanded condition
and a biased, collapsed condition, each of the plurality of
self-expanding sections being foldable in the longitudinal
direction and about the separate joint when in a biased, collapsed
condition, wherein the at least one joint being oriented in a
V-shape when the plurality of self-expanding sections are in the
biased condition.
25. A system useful for treating an aneurysm in a blood vessel of a
mammalian patient, the aneurysm having a neck, a wall, and a
cavity, comprising: an elongated shaft having a proximal end, a
distal end, a longitudinal direction defined between the proximal
end and the distal end, and including at least one lumen extending
therethrough; a self-expanding frame positioned at the distal end
of the shaft, the frame including a plurality of self-expanding
sections disposed in the longitudinal direction, each of said
self-expanding sections being connected to an adjacent
self-expanding section via a separate joint, each of the plurality
of self-expanding sections having an unbiased, expanded condition
and a biased, collapsed condition, each of the plurality of
self-expanding sections being foldable in the longitudinal
direction and about the separate joint when in a biased, collapsed
condition, wherein the at least one joint collapses to a position
parallel to an artery of the patient.
Description
[0001] This application is related to and claims priority under 35
U.S.C. .sctn.119 to U.S. provisional patent application Ser. No.
60/224,361, filed Aug. 11, 2000, the entire contents of which are
incorporated by reference herein.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to systems and processes for
treating an aneurysm, and more particular to an endovascular system
and process for collapsing an aneurysm.
[0004] 2. Discussion of Related Art
[0005] Aneurysm treatments have been proposed using a wide variety
of processes and devices, which have enjoyed various levels of
success and acceptance. Such systems and processes include aneurysm
clips, intravascular coils, intravascular injections, detachable
intravascular balloons, and the like.
[0006] These prior devices, however, have proven to be difficult to
employ, oftentimes do not lend themselves to deployment in all
sizes of aneurysms, can be imprecise in their deployment, their
installation can be very time consuming, risk rupture of the
aneurysm because they increase its size, can risk recanalization
and/or migration of the device in the patient's vasculature, and
may not treat the mass effect that the aneurysm may have caused.
Furthermore, the present of adhesions in the aneurysm makes it
difficult to collapse the aneurysm. There therefore remains an
unmet need in the art for systems and processes which do not suffer
from one or more of these deficiencies.
SUMMARY OF THE INVENTION
[0007] According to a first aspect of the invention, a method of
treating an aneurysm in a patient comprises the steps of advancing
a compressed clip through the distal end of a catheter and into the
aneurysm, expanding portions of the clip inside the aneurysm, and
folding a distal segment of the clip on itself together with the
adjacent wall of the aneurysm as it becomes dislodged from the
stretching bar.
[0008] According to a second aspect of the invention, a system
useful for treating an aneurysm in a blood vessel of a mammalian
patient, the aneurysm having a neck, a wall, and a cavity,
comprises an elongated shaft having a proximal end, a distal end, a
longitudinal direction defined between the proximal end and the
distal end, and including at least one lumen extending
therethrough, and a self-expanding frame positioned at the distal
end of the shaft, the frame including a plurality of self-expanding
sections and at least one joint, each of the plurality of
self-expanding sections having an unbiased, expanded condition and
a biased, collapsed condition, each of the plurality of
self-expanding sections being foldable about one of the at least
one joint when in a biased, collapsed condition.
[0009] According to a third aspect of the invention, a catheter
useful for accessing a vascular location adjacent to an aneurysm,
comprises a hollow shaft including a proximal end, a distal end, a
longitudinal direction defined between the proximal end and the
distal end, a port in a distal portion of the shaft, and including
at least one lumen extending therethrough, and an inflatable member
mounted on the shaft adjacent to the shaft distal end, the
inflatable member in fluid communication with the shaft at least
one lumen, the inflatable member including a proximal end, a distal
end, and a wall between the proximal end and the distal end which
extends to the shaft so that the shaft port is directly exposed to
the exterior of the balloon, the wall delimiting a central working
channel.
[0010] According to a fourth aspect of the invention, a method of
treating an aneurysm in a patient comprises the steps of advancing
a compressed clip through the distal end of a catheter and into the
aneurysm, expanding portions of the clip inside the aneurysm, and
folding a distal segment of the clip on itself together with the
adjacent wall of the aneurysm as it becomes dislodged from the
stretching bar.
[0011] Still other objects, features, and attendant advantages of
the present invention will become apparent to those skilled in the
art from a reading of the following detailed description of
embodiments constructed in accordance therewith, taken in
conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The invention of the present application will now be
described in more detail with reference to preferred embodiments of
the apparatus and method, given only by way of example, and with
reference to the accompanying drawings, in which:
[0013] FIGS. 1a and 1B illustrates longitudinal and cross-sectional
views of an exemplary embodiment of an apparatus in accordance with
the present invention;
[0014] FIG. 2 illustrates the apparatus of FIG. 1 in use according
to an exemplary method;
[0015] FIG. 3 illustrates a step later than that illustrated in
FIG. 2 in the exemplary method;
[0016] FIGS. 4a and 4b illustrate a step later than that
illustrated in FIG. 2 in the exemplary method, utilizing two
embodiments of apparatus illustrated in FIG. 1;
[0017] FIGS. 5a and 5b illustrate two embodiments of apparatus in
accordance with the present invention;
[0018] FIGS. 6a-6c illustrate successive steps of use of an
apparatus in accordance with the present invention;
[0019] FIG. 7 illustrates a vascular aneurysm after collapse
thereof in accordance with the present invention;
[0020] FIG. 8 illustrates a distal end of yet another embodiment of
a device in accordance with the present invention;
[0021] FIG. 9 illustrates a side elevational view of a catheter in
accordance with the present invention;
[0022] FIG. 10 illustrates a top plan view of the catheter of FIG.
9;
[0023] FIGS. 11-17 diagrammically illustrate several steps of
treating an aneurysm in accordance with an aspect of the present
invention;
[0024] FIGS. 18-21 diagrammically illustrate several steps of
treating an aneurysm in accordance with another aspect of the
present invention;
[0025] FIG. 22 illustrates a distal end of yet another embodiment
of a device in accordance with the present invention; and
[0026] FIGS. 23-28 diagrammically illustrate several steps of
treating an aneurysm in accordance with yet another aspect of the
present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0027] Apparatus and methods in accordance with the present
invention have numerous advantages over prior aneurysm clips and
methods. Among these advantages, immediate closure of an aneurysm
can be achieved with a relatively easy-to-use method. The apparatus
and methods can be used to treat all aneurysms regardless of the
size or the neck width, and can achieve precise locational
deployment and decreased procedure time. The risk of rupture can be
decreased, since the aneurysm volume is never increased.
Additionally, occlusion of the aneurysm neck can be achieved by a
balloon in case rupture does occur. Decreased risk of distal
embolization, little or no risk of recanalization or migration,
strengthening of the arterial wall at the site of the aneurysm,
good visualization of the device during and after deployment, and
immediate elimination of any mass effect the aneurysm may have
caused can also be achieved.
[0028] Referring to the drawing figures, like reference numerals
designate identical or corresponding elements throughout the
several figures.
[0029] FIGS. 1a and 1b illustrate a first exemplary embodiment of a
system in accordance with the present invention. The system 100
includes a triple lumen catheter 102 having a sidewall 104 and
three lumenae 106, 108, 110 extending longitudinally therethrough.
An inflatable member 112, such as a balloon, is positioned adjacent
a distal end 114 of the catheter, and is in fluid communication
with one of the three lumenae, e.g., lumen 106. A collapsible
element or clip 116 is removably mounted to the distal end of the
catheter and is movable between a retracted and collapsed
condition, illustrated in FIG. 1a, and an extended and expanded
condition, illustrated in FIGS. 4a, 4b, 5a, and 5b. In order to
effect collapse and expansion of the clip 116, a longitudinally
movable stretching bar 118 extends proximally from the distal end
of the catheter, and preferably extends both within the clip 116
and the one of the catheter lumenae, e.g., lumen 108.
[0030] The system 100 also preferably includes a flexible portion
in the distal end of the catheter 102 so that the catheter can more
easily navigate the sometimes tortuous paths encountered during
endovascular procedures. By way of example and not of limitation, a
spring 120 can be incorporated into the distal portions of the
catheter 102, preferably proximal of the balloon 112, to permit the
catheter to more easily flex and bend. A pair of steering wires 122
are attached to the catheter distal to the flexible portion 120 and
to a steering mechanism or station 124 at the proximal end of the
catheter. Steering mechanisms for catheters have previously been
proposed in the patent literature, and therefore a detailed
description of station 124 will be omitted herein.
[0031] The catheter 102 also preferably includes at least one, and
more preferably several distal side perfusion holes 126 which are
in fluid communication with one of the three lumenae, e.g., lumen
110. The catheter also includes a one way valve 128 positioned
distally of the balloon 112 and also in fluid communication with
one of the lumenae. Valve 128 is oriented to permit a vacuum drawn
in the catheter to suction through the valve, for purposes which
will be explained in greater detail below. In accordance with one
preferred embodiment, both the side holes 126 and the valve 128 are
in fluid communication with the same lumen; because the one way
valve 128 only permits flow into the catheter through the valve,
perfusion of fluid, e.g. contrast agent, through the side holes 126
will not exit out the catheter through the valve.
[0032] Turning briefly to FIGS. 5a, 5b, and 6a-c, further details
of clips in accordance with the present invention are illustrated.
In general, clips in accordance with the present invention are
releasable from the catheter or other deployment device inside an
aneurysm. The clips also have a collapsed condition into which the
clips are biased by their own structures, and an expanded condition
into which the clips must be moved. FIGS. 5a and 5b illustrate two
different versions of a clip 116 in an expanded condition, with the
stretching bar 118 extending through the catheter 102 and through
the clip 116. As illustrated in FIGS. 5a and 5b, the stretching bar
118 also includes a thread, wire, or the like 130 which is
connected to the distalmost end of the stretching bar and extends
proximally through the catheter 102, preferably within the
stretching bar itself.
[0033] The stretching bar 118 includes at least one, and preferably
several telescoping sections 132a-f of decreasing outer diameter.
Thus, section f can slide into section e, section e into section d,
and so forth, when the wire 130 is pulled proximally. The clip 116
includes at least one, and preferably several rings 134a-f which
are releasably held on the outer surface of the stretching bar 118,
e.g., by a friction fit, a frangible coupling, or the like. To each
ring 134 a set of arms 136 are attached so that the arms can
articulate and fold in toward the stretching bar, in a manner
somewhat similar to an umbrella. An outer trellis or covering 138
extends between the opposite ends of the arms.
[0034] In order to deploy the clip 116, the distal end of the
catheter 102 is positioned in the neck of an aneurysm, as
illustrated in FIG. 2. The stretching bar, which is already in its
own expanded condition, is pushed distally, carrying with it the
collapsed clip 116. As the clip exits the distal end of the
catheter, as through a distal port 140, successive sections of the
clip expand outward until the clip is fully exposed and outside of
the catheter. The wire 130 is then pulled proximally, causing the
sections of the stretching bar to telescope into one another, with
the distalmost section 132f moving proximally first into the next
most distal section 132e. As the distalmost end of the section 132f
moves into the distalmost end of the section 132e, the ring 134
which was received on the section 132f is pulled off of the
stretching bar, leaving that distalmost section of the clip
collapsed proximally against the adjacent section. The wire 130 is
pulled proximally until each of the sections 132 has telescoped
into the adjacent section, causing a collapsing cascade of the clip
sections proximally. When the proximalmost section of the
stretching bar has been retracted, the clip is left fully collapsed
and separated from the stretching bar and the deployment device,
e.g., catheter 102. FIGS. 6a-6c illustrate successive views of this
serial collapse of the clip from a side view, while FIG. 7
schematically illustrates the completely collapsed clip in
situ.
[0035] According to additional embodiments, the releasable
connections between the arms 136 and the stretching bar 118 can be
formed as twist locks, meltable connections, for which a resistive
heater is positioned at each arm and voltage source is connected
thereto, or the like as will be readily appreciated by one of
ordinary skill in the art.
[0036] Turning now to FIG. 8, yet another embodiment of a clip in
accordance with the present invention is illustrated. Clip 200
includes a longitudinally extending hollow, preferably cylindrical
shaft 202 which extends to a closed, and optionally sealed, distal
end 204. A self-expanding frame 206 is mounted about the distal
portions of the shaft 202, and includes a number of segments which
can fold about a number of collapsing joints 208. Preferably, the
joints 208 are positioned in an alternating fashion on different
sides of the clip 200, so that the clip can be folded up in an
accordion-type manner. When each of the segments of the frame 206
fold about each joint 208, that segment folds onto an adjacent
segment, as described in greater detail below. Each joint 208
includes a laterally extending leaf spring which has an unbiased,
V-shaped orientation and a biased, flat orientation. Because of the
presence of the spring in each joint 208, each segment is biased to
fold upon itself, as illustrated in the drawing figures. A
stiffening wire, stretching bar, or mandrel 210 extends through
each of the segments of the frame, and prevents the springs of each
of the joints 208 from folding each segment upon itself, as
described in greater detail below.
[0037] The stiffening wire or stretching bar 210 extends
longitudinally through the shaft 202. The wire or bar 210 allows
the practitioner to straighten or laterally collapse the frame 206;
that is, when the bar/wire/mandrel 210 is pushed distally against
the distal end 204, the frame 206 can be stretched and collapsed,
and proximal retraction removes this force on the frame and permits
the frame to expand. Self-expanding frames are well known to those
of skill in the art, such as those known for use in constructing
vascular stents, and therefore the constructional details of frame
206 are omitted from this description for brevity's sake. As
described in greater detail below, the self-expanding frame is
constrained from expanding when advanced through the vasculature
because the frame is carried in a catheter shaft which is sized to
prevent the frame from expanded until the clip is moved out of the
catheter. Such a practice is also known in the art of vascular
stents, which are typically carried in a collapsed condition inside
a carrier catheter, and thereafter pushed out of the catheter which
permits them to expand.
[0038] Preferably, at least portions of the shaft 202 are
configured so that upon rotation of the shaft about the
longitudinal axis, the shaft is released from the frame 206. By way
of example and not of limitation, distal portions of the shaft 202
can include a detent which will pass through correspondingly sized
and shaped holes in the sections of the frame 206 only when the
shaft is rotated to align the detent and hole. Other suitable
mechanisms will be readily apparent to those of skill in the
art.
[0039] FIGS. 9 and 10 illustrate side elevational and top plan
views, respectively, of a catheter 220 which is useful for
accessing and positioning a clip, such as clip 200, in an aneurysm
10. The catheter 220 includes a longitudinally extending shaft 222
dimensioned and formed of materials so that it can traverse the
vasculature of the patient to be positioned immediately next to an
aneurysm that the practitioner intends to treat. An inflatable
balloon 224 is mounted on the distal end of the shaft 222, and
includes proximal 226 and distal 228 inflatable portions. A central
working channel 228 is formed in the balloon 224 by a portion 246
of the wall of the balloon extending inward to the shaft 222.
Preferably, at least one, and more preferably several radiopaque
markers 230 are located around the central working channel 228 so
that it's position in the patient can be monitored
fluoroscopically.
[0040] The catheter 220 also preferably includes a mechanism or the
like which directs a clip radially outward through the working
channel 228 when the clip is pushed distally through the shaft 222.
According to one exemplary embodiment, this mechanism can be a ramp
shaped surface formed in the lumen of the shaft 222, so that when
the clip is pushed distally through the shaft, the clip's distal
motion is converted into radial motion out of the shaft and into
the working channel. According to yet another exemplary embodiment,
a deflectable tube 234 can be mounted on the shaft at the base of
the working channel 228, and a steering thread 232 is attached to
the tube 234. The steering thread extends proximally through the
shaft 222 and exits the shaft or is otherwise made available to the
practitioner to manipulate. Upon proximal pulling on the steering
thread 232, the tube 236 can be deflected to point toward the
central working channel 228, thus directing any clip, such as clip
200, which is pushed through the tube 234 into the working
channel.
[0041] Several lumenae extend through the shaft 222. A suction
lumen 236 extends from a distal port 248, located where the working
channel 228 meets the shaft 222, to a proximal fitting or suction
end 238, and includes a lock 242. The lock 242 is operable to seal
the lumen 236 so that a relative vacuum can be maintained in the
lumen. For example, lock 242 can be a stopcock valve. A proximal
fitting 244 leads to another lumen of the shaft 222, and is the
lumen which leads to the deflectable tube 234 and is the lumen in
which the clip, e.g., clip 200, is longitudinally advanceable.
Thus, the clip 200 can be loaded through the fitting 244 or the
tube 234, into the shaft 222 with proximal portions of the clip
extending proximally out of the fitting 244. In this orientation,
the clip is in a collapsed condition because the internal
dimensions of the lumen are selected to constrain the clip from
self-expanding. Thereafter, the clip can be advanced distally
through the tube 234 and laterally into the working channel
228.
[0042] FIGS. 11-17 illustrate several steps in an exemplary method
in accordance with the present invention which utilizes clip 200
and catheter 220, and are described in more detail below.
[0043] Turning now to FIG. 22, yet another embodiment of a clip in
accordance with the present invention is illustrated. Clip 300
includes a longitudinally extending hollow, preferably cylindrical
shaft (not illustrated) which contains a wire/bar/mandrel 308 to
move the clip into an aneurysm. A pair of self-expanding frames
302, 304 are mounted on the end of the clip 300, and include a
collapsing joint 306. As in other embodiments herein, radiopaque
markers 310 are preferably provided on the frames to assist in
positioning the clip 300 in the aneurysm neck 12. The joint 306
includes at least one, and preferably a plurality (two are
illustrated) leaf springs, as described above. The springs are
oriented with both ends on one lateral side of the each of the
frames, i.e., a first V-spring is mounted on the right side of the
frames as illustrated in FIG. 22, and a second V-spring is mounted
on the left side of the frames. Thus, when unconstrained by a
carrying catheter, such as catheter 220, the frames tend to open up
to the orientation illustrated in FIG. 22.
[0044] Another aspect of the present invention includes methods of
treating an aneurysm. Several embodiments of methods in accordance
with the present invention will now be described with reference to
several of the drawing figures, and with reference to several of
the exemplary devices described herein. The methods of the present
invention are not restricted to the particular devices described
herein, but may be performed using other devices which are
employable into an aneurysm cavity and onto the outer surface of
which the aneurysm wall can be collapsed. By way of example and not
of limitation, vascular coils, such as those described in the
numerous U.S. patents to Guglielmi et al (see, e.g., U.S. Pat. No.
6,083,220), can be used as a device in the methods of the present
invention.
[0045] A first exemplary embodiment of a method in accordance with
the present invention, given by way of example and not of
limitation, includes, but is not limited to, the steps of:
[0046] 1. Perform a road-mapping arteriogram with measurement of
the three dimensional size of an aneurysm 10 and its neck 12.
[0047] 2. Access the aneurysm neck using a steerable catheter, e.g.
catheter 102.
[0048] 3. Lock the distal end of the catheter in a position
perpendicular to the center of the neck transverse axis.
[0049] 4. Slowly inflate a balloon mounted on the distal end of the
catheter with a diluted contrast medium up to the previously
measured size of the neck. (see FIG. 2)
[0050] 5. Verify complete occlusion of the neck 12 by injection of
contrast agent through side holes in the catheter positioned just
proximal to the balloon, and simultaneously applying suction
through a one-way valve at the distal end of the catheter. When no
inflow of the contrast into the catheter is demonstrated together
with deformation of the aneurysm with the suction, the aneurysm
neck is completely closed.
[0051] 6. With the neck completely closed, continue suction to
almost complete collapse of the aneurysm by creating a vacuum
within the aneurysm. (see FIG. 3)
[0052] 7. Obtain transverse and longitudinal measurement of the
aneurysm, e.g. using MRI, CT scan, or the like.
[0053] 8. Advance a compressed clip, the size of which has been
chosen according to the previous measurements, through the distal
end of the catheter. The clip, which is constructed using a
principal similar to a self-expanding vascular stent, will start to
expand as it is advanced into the aneurysm. The transverse axis of
the clip is preferably maintained parallel to the longitudinal axis
of the artery 14 from which the aneurysm 10 is arising. (see FIGS.
4 and 5)
[0054] 9. Maintain the vacuum within the aneurysm with continuous
suction to ensure adherence of the aneurysm wall to the sides of
the clip. (FIG. 6a)
[0055] 10. Begin proximal pulling of the wire or thread mounted
within the stretching bar to telescope the very distal segment into
the next proximal segment. (see FIG. 6b)
[0056] 11. The distal segment of the clip, which folds on itself if
not stretched from both ends as described above, will start folding
on itself together with the adjacent wall of the aneurysm as it
becomes dislodged from the stretching bar. (see FIG. 6c) The
aneurysm wall is held to the outside of the clip by the
suction.
[0057] 12. By repeating the process described in steps 10 and 11,
successive segments of the stretching bar and clip will continue to
fold and complete collapse of the aneurysm will be achieved. (see
FIG. 7) The catheter can then be withdrawn.
[0058] A second exemplary embodiment of a method in accordance with
the present invention, given by way of example and not of
limitation, includes, but is not limited to, the steps of:
[0059] 1. Perform a road-mapping arteriogram.
[0060] 2. Obtain measurements of the aneurysm, the neck of the
aneurysm, and the parent artery.
[0061] 3. Using a transvascular approach, e.g., a right femoral
approach, position the balloon catheter 200 in the parent artery
(using the guidance of the radiopaque markers on the periphery of
the central working channel) with the distal segment of the balloon
distal, e.g., immediately distal, of the aneurysm neck, and the
proximal segment proximal, e.g., immediately proximal, to the
aneurysm neck (see FIGS. 9-11)
[0062] 4. Slowly inflate the balloon to achieve occlusion of the
parent artery both proximal and distal to the neck.
[0063] 5. Pull the steering thread within the catheter shaft to
direct the steerable section of the catheter to a position as close
and as perpendicular as possible to the neck (see FIG. 12).
[0064] 6. Apply a moderate amount of suction using a suitable
device, e.g., a syringe attached to a lock mounted on the proximal
end of the catheter to decompress the aneurysm; activate the lock
to maintain the relative vacuum in the aneurysm (see FIG. 10).
[0065] 7. Stiffen the distal segment of the aneurysm clip with the
stiffening wire by pulling on the proximal segment of the wire and
then push it until it reaches the sealed top of the clip.
[0066] 8. Push both the stiffening wire and the clip into the
aneurysm cavity, firmly holding both of these elements together;
the self-expanding frame of the clip will start to expand as the
clip is deployed (see FIG. 13).
[0067] 9. Apply strong suction through the catheter to collapse the
aneurysm wall completely around the expanded clip (see FIG.
14).
[0068] 10. Turn off the vacuum lock at the proximal end of the
catheter while applying strong vacuum to the catheter lumen to
ensure that a vacuum is maintained within the aneurysm to assist,
and preferably ensure, that the aneurysm wall adheres to the
outside of the clip.
[0069] 11. Start pulling the stiffening wire through the sealed
proximal end of the catheter to release the most distal segment of
the clip, which will fold onto itself about the joint because of
the action of the springs in the joints, together with the adjacent
aneurysm wall which is held by the vacuum (see FIGS. 15, 16), which
may be at least in part assisted by the force of the vacuum pushing
inward on the frames of the clip.
[0070] 12. Repeat steps 10 and 11 so that successive segments or
sections of the clip continue to fold and at least partial, and
preferably complete, collapse of the aneurysm will be achieved (see
FIG. 17).
[0071] 13. Rotate the shaft, e.g., counterclockwise, to dislodge
the shaft from the collapsed segment(s) of the clip.
[0072] A third exemplary embodiment of a method in accordance with
the present invention, given by way of example and not of
limitation, includes, but is not limited to, the steps of the above
described second embodiment, with the following modification. The
clip is positioned at the neck of the aneurysm and the very
proximal end of the aneurysm segment. Only the portion of the clip
that is in the aneurysm is folded, leaving the rest of the aneurysm
decompressed but not fully collapsed onto the outer surface of the
clip (see FIGS. 18-21). This and other aspects of the invention can
be particular useful in the treatment of aneurysms which include
adhesions, which make complete collapse of the aneurysm wall
difficult because they make the wall less pliable.
[0073] A fourth exemplary embodiment of a method in accordance with
the present invention, given by way of example and not of
limitation, includes, but is not limited to, utilizing the clip 300
(see FIG. 22) in the following manner and including the steps
of:
[0074] 1. Perform steps 1-6 as described in the second embodiment
above.
[0075] 2. Introduce the distal segment of the clip to a point just
distal of the neck of the aneurysm, i.e., just inside the aneurysm
cavity (see FIG. 25).
[0076] 3. Apply strong suction and lock it in to maintain vacuum in
the aneurysm cavity.
[0077] 4. Pull the distal segment of the clip to push (fold) down
the aneurysm neck (see FIG. 26).
[0078] 5. Introduce the proximal segment of the clip into the
parent artery, e.g., through a catheter 220, just proximal of the
neck and permit or cause the joint of the proximal segment to
collapse (see FIG. 27).
[0079] 6. Dislodge the pushing wire by turning it, e.g., in a
counterclockwise direction (see FIG. 28).
[0080] As will be readily appreciated by one of skill in the, the
present invention also extends to the combination of a deployment
catheter, such as catheter 220, with any of the embodiments of the
aneurysm clips described herein to access and treat an
aneurysm.
[0081] While the invention has been described in detail with
reference to preferred embodiments thereof, it will be apparent to
one skilled in the art that various changes can be made, and
equivalents employed, without departing from the scope of the
invention. Each of the aforementioned published documents is
incorporated by reference herein in its entirety.
* * * * *