U.S. patent application number 10/465975 was filed with the patent office on 2004-04-08 for detachable self -expanding aneurysm cover device.
Invention is credited to Jones, Donald K., Mitelberg, Vladimir.
Application Number | 20040068314 10/465975 |
Document ID | / |
Family ID | 32043514 |
Filed Date | 2004-04-08 |
United States Patent
Application |
20040068314 |
Kind Code |
A1 |
Jones, Donald K. ; et
al. |
April 8, 2004 |
Detachable self -expanding aneurysm cover device
Abstract
A self-expanding aneurysm cover device which takes the form of
an outwardly biased cylindrical skeletal frame in which the
proximal end of the cylindrical skeletal frame forms a loop which
extends at an oblique angle to the axis of the cylindrical skeletal
frame. A positioning tab extends from the proximal end of the
skeletal frame which when pulled causes the cylindrical skeletal
frame to collapse to a reduced diameter for removal of the device
from a vessel.
Inventors: |
Jones, Donald K.;
(Lauderhill, FL) ; Mitelberg, Vladimir; (Aventura,
FL) |
Correspondence
Address: |
PHILIP S. JOHNSON
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
32043514 |
Appl. No.: |
10/465975 |
Filed: |
June 27, 2003 |
PCT Filed: |
January 16, 2002 |
PCT NO: |
PCT/US02/04981 |
Current U.S.
Class: |
623/1.15 |
Current CPC
Class: |
A61B 17/12118 20130101;
A61F 2002/823 20130101; A61B 17/12022 20130101; A61B 2017/1205
20130101; A61F 2/91 20130101; A61F 2/95 20130101; A61F 2230/0008
20130101 |
Class at
Publication: |
623/001.15 |
International
Class: |
A61F 002/06 |
Claims
That which is claimed is:
1. A self-expandable aneurysm cover device comprising a generally
cylindrical skeletal frame having a longitudinal axis, said frame
including a proximal loop portion which extends in a plane which is
oblique to the longitudinal axis of the skeletal frame and which
has a proximal edge, an elongated positioning tab attached to the
proximal edge of the proximal loop portion and extending from said
proximal edge of the proximal loop portion in a direction generally
parallel to the longitudinal axis of the skeletal frame, and also
including a distal spring-biased portion connected to said loop
portion along at least two spaced-apart locations on said proximal
loop portion, said skeletal frame being adapted to assume a normal
first expanded condition in which said spring-biased portion is
expanded to thereby cause said loop portion to be expanded to form
a loop configuration which lies in the plane extending at an
oblique angle to the longitudinal axis of said skeletal frame and
to cause said distal spring-biased portion to take the form of a
generally cylindrical configuration, and upon moving the elongated
positioning tab in a proximal direction said proximal loop portion
is caused to move to a position such that the plane of the loop
portion is relatively parallel to the longitudinal axis of the
skeletal frame thereby causing the spring-biased portion to
collapse which in turn causes the skeletal frame to collapse for
easy withdrawal of the aneurysm cover device from a vessel.
2. A self-expandable aneurysm cover device as defined in claim 1,
wherein the proximal loop portion of the generally cylindrical
skeletal frame lies in the plane which extends about 10 to 70
degrees to the longitudinal axis of the cylindrical skeletal frame
when the skeletal frame is in the normal first expanded
condition.
3. A self-expandable aneurysm cover device as defined in claim 2,
wherein the proximal loop portion of the generally cylindrical
skeletal frame lies in the plane which extends to about 20 degrees
to the longitudinal axis of the cylindrical skeletal frame when the
skeletal frame is in the normal first expanded condition.
4. A self-expandable aneurysm cover device as defined in claim 1,
wherein the cylindrical skeletal frame includes outer struts which
define an outer edge of the skeletal frame and inner struts which
form a connecting mesh within the outer struts in which the outer
struts are larger in cross section than the inner struts.
5. A self-expandable aneurysm cover device as defined in claim 4,
wherein the spacing between the inner struts is much less at a
central region of the skeletal frame as compared to spacing at
outer regions of the skeletal frame.
6. A self-expandable aneurysm cover device comprising an outwardly
biased cylindrical skeletal frame having a longitudinal axis and
proximal and distal ends, said cylindrical skeletal frame including
a proximal generally oval-shaped ring portion which lies in a plane
extending at an oblique angle to the longitudinal axis of the
cylindrical skeletal frame and which also includes a proximal edge,
and an elongated positioning tab attached to the proximal edge of
the proximal ring portion and extending from said proximal edge of
said proximal ring portion in a direction parallel to the
longitudinal axis of the cylindrical skeletal frame such that when
said positioning tab is moved in a direction proximal to the
cylindrical skeletal frame the skeletal frame is caused to collapse
radially for easy removal of the aneurysm cover device from a
vessel.
7. A self-expandable aneurysm cover device as defined in claim 6,
wherein the oblique angle of an oval-shaped ring portion of the
generally cylindrical skeletal frame is about 10 to 70 degrees to
the longitudinal axis of the cylindrical skeletal frame.
8. A self-expandable aneurysm cover device as defined in claim 7,
wherein the oblique angle of the ring portion of the generally
cylindrical skeletal frame is about 20 degrees to the longitudinal
axis of the cylindrical skeletal frame.
9. A self-expandable aneurysm cover device as defined in claim 6,
wherein the cylindrical skeletal frame includes outer struts which
define an outer edge of the skeletal frame and inner struts which
form a connecting mesh within the outer struts in which the outer
struts are larger in cross section than the inner struts.
10. A self-expandable aneurysm cover device as defined in claim 9,
wherein the spacing between the inner struts is much less at a
central region of the skeletal frame as compared to spacing at
outer regions of the skeletal frame.
11. A self-expandable aneurysm cover device comprising a generally
cylindrical skeletal frame having a longitudinal axis and proximal
and distal ends, said cylindrical skeletal frame having a first
condition in which said cylindrical skeletal frame may be
compressed to have an overall small outside diameter and a normally
biased second condition in which said cylindrical skeletal frame
has an overall larger diameter, said cylindrical skeletal frame
defining a loop portion at its proximal end such that when said
cylindrical skeletal frame is in its normally biased second
condition the loop portion lies in a plane extending at an oblique
angle to the longitudinal axis of the cylindrical skeletal frame
and has a proximal edge, an elongated positioning tab attached to
the proximal edge of the loop portion and extends proximally from
the proximal edge of the loop portion in a direction generally
parallel to the longitudinal axis of the skeletal frame, said
cylindrical skeletal frame being adapted to move from its normally
biased second condition to a compressed condition when the
elongated positioning tab is moved proximal to the skeletal frame
thereby causing the loop portion to move to a position such that
the loop portion lies in the plane extending approximately parallel
to the longitudinal axis of the skeletal frame.
12. A self-expandable aneurysm cover device as defined in claim 11,
wherein the proximal loop portion of the cylindrical skeletal frame
lies in the plane which extends about 10 to 70 degrees to the
longitudinal axis of the cylindrical skeletal frame when the
skeletal frame is in the normally biased second condition.
13. A self-expandable aneurysm cover device as defined in claim 12,
wherein the proximal loop portion of the generally cylindrical
skeletal frame lies in the plane which extends to about 20 degrees
to the longitudinal axis of the cylindrical skeletal frame when the
skeletal frame is in the normally biased second condition.
14. A self-expandable aneurysm cover device as defined in claim 11,
wherein the cylindrical skeletal frame includes outer struts which
define an outer edge of the skeletal frame and inner struts which
form a connecting mesh within the outer struts in which the outer
struts are larger in cross section than the inner struts.
15. A self-expandable aneurysm cover device as defined in claim 14,
wherein spacing between the inner struts is much less at a central
region of the skeletal frame as compared to spacing at outer
regions of the skeletal frame.
16. A method of placing and then repositioning a self-expandable
aneurysm cover device which includes a generally cylindrical
skeletal frame in which the cylindrical skeletal frame defines a
loop portion at its proximal end, the loop portion normally lies in
a plane extending at an oblique angle to a longitudinal axis of the
cylindrical skeletal frame, a positioning tab is attached to the
loop portion and extends from the proximal end of the loop portion
in a direction generally parallel to the longitudinal axis of the
skeletal frame comprising the steps of; inserting into a vessel the
aneurysm cover device which is compressed and carried within a
lumen of a delivery catheter; positioning the aneurysm cover device
at a preselected position within a vessel; moving the positioning
tab of the aneurysm cover device distally to cause the device to
move completely out of the lumen of the catheter thereby causing
the device to completely expand into contact with the walls of the
vessel; and, moving the positioning tab of the aneurysm cover
device proximally through the lumen of the delivery catheter to
thereby cause the loop portion which is normally in a plane oblique
to the longitudinal axis of the skeletal frame to move into the
plane relatively parallel to the longitudinal axis of the skeletal
frame to thereby cause the aneurysm cover device to collapse into
the lumen of the catheter to permit repositioning of the device to
another position within the vessel.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to a repositionable
self-expanding intravascular aneurysm cover device and a hydraulic
deployment system for placing the device at a preselected location
within a vessel of the human body, and more particularly, relates
to a device and hydraulic deployment system for the device which
may be used to initially place the aneurysm cover device at a first
location within a vessel and if it is desirable to reposition the
device, the device may be withdrawn into the deployment system and
subsequently repositioned at a different location.
[0003] 2. Description of the Prior Art
[0004] For many years flexible catheters have been used to place
various devices within the vessels of the human body. Such devices
include dilatation balloons, stents, embolic coils and aneurysm
covers. Examples of such catheter devices are disclosed in U.S.
Pat. No. 5,108,407, entitled, "A Method And Apparatus For Placement
Of An Embolic Coil"; U.S. Pat. No. 5,122,136, entitled,
"Endovascular Electrolytically Detachable Guidewire Tip For The
Electroformation Of Thrombus In Arteries, Veins, Aneurysms,
Vascular Malformations And Arteriovenous Fistulas." These patents
disclose devices for delivering an embolic coil to a preselected
position within a vessel of the human body in order to treat
aneurysms, or alternatively, to occlude the blood vessel at the
particular location.
[0005] Devices, such as stents, which are placed in vessels may
take the form of helically wound wire, or tubular like structures,
with numerous patterns defining the walls. Examples of various
stent configurations are disclosed in U.S. Pat. No. 4,512,338,
entitled, "Process For Restoring Patentcy To Body Vessels"; U.S.
Pat. No. 5,551,954, entitled, "Biodegradable Drug Delivery Vascular
Stent"; and U.S. Pat. No. 4,994,071, entitled, "Bifurcating Stent
Apparatus And Method." Stents are generally formed of materials
which retain their shape under the pulsatile flow conditions
encountered when placed within the body vessel. Some materials that
have been used to make such stents include metals and alloys, such
as, stainless steel, tantalum, tungsten and nitinol, as well as
polymers such as polyvinyl alcohol (PVA), polyglycolic acid (PGA)
and collagen. On occasion multiple stents are placed at a given
location to provide the desired vascular support.
[0006] In the past, the deployment of stents has been accomplished
by numerous techniques. One such technique used to deploy a typical
wire stent uses a pusher wire to push the wire stent through the
lumen of a properly positioned cannula. As the stent exits the
cannula it takes a predetermined shape until completely deposited
in the vessel. This procedure is usually conducted under
fluoroscopic visualization, such that the movement of the stent
through the vasculature can be monitored. With these placements
systems there is very little control over the exact placement of
the stent since the stent may be ejected to a position some
distance beyond the end of the cannula. As is apparent, with these
latter systems, when the stent has been released from the cannula
it is difficult, if not impossible, to retrieve the stent or to
reposition the stent.
[0007] Numerous procedures have been developed to enable more
accurate positioning of stents within a vessel. One such procedure
utilizes a helically wound wire loop stent with a relaxed diameter.
The stent is wound on a smaller diameter delivery while fixing the
ends of the stent. This keeps the stent in a small diameter,
tightly wound coil. This system is then delivered through the lumen
of a properly positioned catheter exiting at a desired location.
Once the delivery wire is activated to release the ends of the
stent, the stent radially expands to its relaxed larger diameter.
Such a stent positioning method is disclosed in U.S. Pat. No.
5,772,668, entitled, "Apparatus For Placing An Endoprosthesis."
[0008] Another stent positioning system utilizes a self-expanding
tubular stent. This stent has a relaxed diameter that approximates
the diameter of the vessel to be supported. For transport through
the catheter, the stent is positioned on a smaller diameter
delivery wire. A sheath is positioned over the stent/delivery wire
assembly constraining the stent to a smaller diameter. Once the
assembly is placed at the desired location in the vasculature, the
sheath is withdrawn exposing the stent allowing the stent to return
to its predetermined larger size. The expansion of the stent
uncouples the stent from the delivery wire while depositing the
stent in the vessel at the desired location.
[0009] Still another stent positioning system utilizes a hydraulic
stent deployment system for placing a self-expandable stent into
the vessels of the body, and in particular into the small vessels
of the brain. More particularly, this stent positioning system
utilizes a catheter having a distal tip for retaining the stent in
order to transport the stent to a predetermined position within a
vessel and a control mechanism for releasing the stent at the
preselected position. The control mechanism generally takes the
form of a pressure generating device, such as a syringe, which is
used to apply pressure to the catheter to thereby cause the distal
end of the catheter to expand radially which in turn causes the
stent to be released from the distal tip of the catheter. An
example of such a stent positioning system is illustrated in U.S.
Pat. No. 6,254,612, entitled, "Hydraulic Stent Deployment Systems,"
and assigned to the same assignee as the present invention.
[0010] An example of a self-expanding tubular stent is illustrated
in U.S. Pat. No. 6,267,783, entitled, "Stent Which Is Easily
Recaptured And Repositioned Within The Body." This self-expanding
stent is formed by cutting and removing diamond shaped sections
from the wall of a thin-walled nitinol tube to thereby form a
relatively flexible, skeletal, tubular stent. The stent may be
compressed to a smaller size for insertion into a vessel and then
may be permitted to expand to a size where the stent contacts the
walls of a vessel. The disclosed stent may also be recaptured and
repositioned within a vessel.
[0011] An example of a self-expanding aneurysm cover is shown in
U.S. Pat. No. 5,591,195 entitled, "Apparatus And Method For
Engrafting A Blood Vessel." The aneurysm cover illustrated in this
patent is comprised of an expandable wire frame, which upon
expansion, supports a fabric material which covers the mouth of an
aneurysm.
SUMMARY OF THE INVENTION
[0012] The present invention is directed toward a deployment system
and a aneurysm cover device which may be delivered at a site within
a vessel and may be withdrawn after placement and to reposition the
device at another site within the vessel.
[0013] In accordance with one aspect of the present invention, the
self-expanding aneurysm cover device deployment system also
includes a delivery catheter through with the device is delivered
to the predetermined location. Initially, the device is retained by
the deployment catheter within a delivery catheter and the device
is positioned within the lumen of the distal section of the
delivery catheter. The deployment catheter and the delivery
catheter are moved to a desired position within a vessel and the
deployment catheter is moved distally to permit the device to be
pushed out of the distal end of the delivery catheter. The aneurysm
cover device, being a self-expanding device, expands radially and
contacts the walls of the vessel. If, prior to the final release of
the aneurysm cover device from the deployment catheter it is
determined that the device should be repositioned to another
position within the vessel, the deployment catheter may be moved
proximally back into the delivery catheter. As the aneurysm cover
device is withdrawn into the delivery catheter, the device
collapses to fit within the lumen of the delivery catheter. Once
the device has been withdrawn into the delivery catheter, the
delivery catheter may be moved into another position within the
vessel for repositioning and subsequent release of the device.
Accordingly, with this aneurysm cover device design is possible to
permit the self-expanding device to completely expand at a first
location, to then withdraw the device back into the delivery
catheter, to move the delivery catheter to a second position and to
again expand the device at the second position for subsequent
release of the device.
[0014] In accordance with another aspect of the present invention,
the self-expanding aneurysm cover device includes a generally
cylindrical skeletal frame in which the frame includes a proximal
loop portion, a positioning tab attached to the proximal loop
portion and extending from the loop portion in a direction
generally parallel to the longitudinal axis of the skeletal frame,
and also includes a distal spring biased portion connected to the
loop portion along at least two spaced apart locations on the loop
portion. The skeletal frame is adapted to assume a first expanded
position in which the spring portion is expanded to thereby cause
the loop portion to be expanded to form a generally cylindrical
loop configuration which lies in a plane extending in an oblique
angle to the longitudinal axis of the skeletal frame. When the
distal tab is moved proximally with respect to the skeletal frame,
the skeletal frame becomes compressed so that the loop portion lies
in a plane extending generally parallel to the longitudinal axis of
the skeletal frame thereby causing the spring-biased portion to
collapse which in turn causes the loop portion to collapse for easy
withdraw of the aneurysm cover device from a vessel.
[0015] In accordance with still another aspect of the present
invention, the self-expandable aneurysm cover device includes an
outwardly biased cylindrical skeletal frame in which the skeletal
frame defines a proximal loop portion which lies in a plane
extending at an oblique angle to the longitudinal axis of the
cylindrical skeletal frame. The cover device also includes a
positioning tab attached to the proximal end of the skeletal frame
such that when force is applied to the positioning tab to cause the
tab to move in a direction proximally of the cylindrical skeletal
frame, the frame is caused to collapse radially for easy removal of
the aneurysm cover device from a vessel.
[0016] In accordance with still another aspect of the present
invention, the aneurysm cover device includes a generally
cylindrical frame having a first condition in which said
cylindrical skeletal frame may be compressed to have an overall
small outside diameter and a normally biased second condition in
which the cylindrical skeletal frame has an overall larger
diameter. The cylindrical skeletal frame defines a loop portion at
its proximal end in which the loop portion lies in a plane
extending at an oblique angle to the longitudinal axis of the
cylindrical skeletal frame. Also the device includes a positioning
tab attached to the loop portion and extending from the proximal
end of the loop portion in a direction generally parallel to the
longitudinal axis of the skeletal frame. When a pulling force is
applied to the positioning tab in a direction proximal to the
cylindrical frame, the cylindrical frame is caused to collapse to
form a device which has a reduced outside diameter therefore which
may be easily removed from a vessel.
[0017] In accordance with another aspect of the present invention,
the deployment system includes an elongated flexible deployment
catheter having a distal section for retaining the aneurysm cover
device so the device may be moved to a preselected position within
the vessel. The catheter has a lumen which extends throughout the
length of the catheter and also includes a distal section which is
formed of a material having a durometer such that when sufficient
fluid pressure is applied to the interior of the deployment
catheter, the walls of the distal tip expand outwardly, or
radially, to thereby increase the size of the lumen at the distal
section of the catheter. A headpiece element, or protruding tab, of
the aneurysm cover device is placed into the lumen at the distal
section of the catheter and is retained by the distal section of
the catheter. A hydraulic injector, such as a syringe, is coupled
to the proximate section of the catheter for applying a fluid
pressure to the interior of the catheter. When the device is placed
at the desired position within the vessel, fluid pressure is
applied to the interior of the deployment catheter by the hydraulic
injector to thereby cause the walls of the distal section to expand
outwardly thereby releasing the device for placement in the
vessel.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 is an enlarged, partially sectioned view of an
embodiment of the hydraulic deployment system and aneurysm cover
device in accordance with the present invention;
[0019] FIG. 2 is an enlarged elevational view showing the aneurysm
cover device of the present invention in an expanded
configuration;
[0020] FIG. 3 is an enlarged elevational view of the aneurysm cover
device shown in FIG. 2 when viewed from the bottom;
[0021] FIG. 4 is an enlarged oblique view of the aneurysm cover
device as shown in FIG. 2;
[0022] FIG. 5 illustrates the aneurysm cover device of the present
invention positioned within a delivery catheter prior to delivery
of the aneurysm cover device into a vessel;
[0023] FIG. 6 is an enlarged partially sectioned view illustrating
the aneurysm cover device of FIG. 5 after expansion of the device
in a vessel; and,
[0024] FIG. 7 is an enlarged partial sectioned view illustrating
the aneurysm cover device partially withdrawn into the delivery
catheter and partially collapsed for subsequent repositioning
within a vessel.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0025] FIG. 1 generally illustrates the intravascular aneurysm
cover device deployment system 100 which is comprised of a
hydraulic injector or syringe 102, coupled to the proximal end of a
deployment catheter 104. An intravascular aneurysm cover device is
disposed within the lumen of the distal section 108 of the catheter
104. The proximal end of the aneurysm cover device is tightly held
within the lumen of the distal section 108 of the catheter 104
until the deployment system is activated for release of the
aneurysm cover device. As may be seen, the syringe 102 includes a
threaded piston 110 which is controlled by a handle 112 for
infusing fluid into the interior of the catheter 104. Also as
illustrated, the catheter 104 includes a winged hub 114 which aids
in the insertion of the catheter into the access catheter 116 which
has a proximal hub 118 that is placed in the vascular system of the
body. The intravascular aneurysm cover device deployment system 100
is described in more detail in U.S. Pat. No. 6,254,612, entitled,
"Hydraulic Stent Deployment System" and assigned to the assignee of
the present invention. This patent and the disclosure thereof is
incorporated herein by reference.
[0026] FIGS. 2, 3 and 4 illustrate in more detail the intravascular
self-expanding aneurysm cover device. The aneurysm cover device is
comprised of a headpiece element 122 which extends from the
proximal end of a self-expanding skeletal tubular section 124.
[0027] The tubular section 124 is preferably formed from a
thin-walled cylindrical tube formed from a super elastic alloy of
nickel and titanium, such as nitinol. A description of medical
devices which utilize such alloys may be found in U.S. Pat. No.
4,665,906, entitled, "Medical Devices Incorporating Sim Alloy
Elements," which is hereby incorporated by reference. The tubular
section 124 is preferably laser cut from a nitinol tube and
thereafter treated so as to exhibit super elastic properties at
body temperature. As illustrated, tubular section 124 is formed by
removing diamond patterned sections from the sidewalls of the
nitinol tube, and when the aneurysm cover device is fully expanded,
the diamonds would have angles of between 20 and 70 degrees at
their distal and proximal ends. As is apparent, the tubular section
124 may be formed with various other patterns or
configurations.
[0028] Also, and as illustrated in FIGS. 1 through 3 subsequent to
cutting the diamond patterned sections from the tubular section
124, the proximal end of the tube is cut to form a loop
configuration 125 which extends in a plane which is oblique to the
longitudinal axis of the tubular section 124. This angle is
preferably between about 10 and 70 degrees to the longitudinal axis
of the aneurysm cover device. The preferred angle is 20 degrees to
the longitudinal axis. After the diamond patterned sections are
cut, there is formed a continuous proximal oval shaped loop 126.
The headpiece element 122 is connected to the most proximal edge of
the proximal oval shaped loop 126. The headpiece element 122 is
retained by the deployment catheter 104. FIGS. 1 through 3
illustrate the aneurysm cover device in its normal or expanded
state prior to insertion into a delivery catheter for insertion
into a vessel of the body.
[0029] As may be noted in FIGS. 2 and 4, the pattern is constructed
such that the diamonds which are in the lower portion of this
Figure, i.e., diamonds on opposite side of aneurysm cover device
from the portion of the aneurysm cover device which covers the
aneurysm, are larger in size than the diamonds in the upper portion
of this Figure which results in a denser mesh existing in the
portion of the aneurysm cover device which covers the aneurysm.
[0030] As also may be noted in FIG. 2 and FIG. 4, the aneurysm
cover device includes outer struts 129 which are cut of a wider
thickness than the inner struts 131 which causes the outer
structure of the aneurysm cover device to provide a more rigid
structure for holding the aneurysm cover device into the vessel and
across the aneurysm. The rigid outer struts 129 also provide
additional rigidity to improve "pushability" of the aneurysm cover
device through the delivery catheter 128.
[0031] As further noted in FIG. 3, the aneurysm cover device
includes four radiopaque markers 133a, 133b, 133c and 133d which
aide in the positioning of the aneurysm cover device across an
aneurysm. The radiopaque markers 133a through 133d are preferably
formed by electroplating the distal portions of the struts with a
radiopaque material, such as gold. As may be observed in FIGS. 2
and 3, the radiopaque markers 133d and 133c do not extend distally
as far as marker 133a and 133d. The longer markers 133a and 133b
provide an indication of the more dense (upper portion of FIG. 2)
portion of the aneurysm cover device to thereby aide in placement
of the aneurysm cover device across the aneurysm in two respects.
The longer markers 133a and 133b assist in placing the more dense
portion of the aneurysm cover device at a position across the
aneurysm and also provide an indication of the width of the more
dense portion of the aneurysm cover device relative to the
aneurysm.
[0032] As may be appreciated the aneurysm cover device may be
delivered using various types of delivery systems other than the
hydraulic delivery system disclosed in the present patent
application. Such other devices may use heat, electric or
mechanical systems to release the aneurysm cover device into a
vessel with or without other embolic devices, such as embolic
coils.
[0033] The aneurysm cover device may be treated by applying a
coating to reduce the occurrence of a stenosis or to improve
compatibility with other embolic devices. An example of a coating
to reduce the occurrence of a stenosis is rapamycine. U.S. Pat.
Nos. 5,288,711; 5,516,781; 5,563,146; 5,646,160 and 5,665,728 all
disclose techniques for applying this coating to medical devices.
The disclosures of these patents are incorporated by reference
herein. In addition, the aneurysm cover device may be covered by a
fabric covering, such as a polymer mesh, to more completely seal
the opening of an aneurysm.
[0034] As illustrated in FIG. 5, the self-expanding aneurysm cover
device is placed within a delivery catheter 128 which serves to
compress the aneurysm cover device to size sufficiently small so
that it may be inserted into a vessel and across an aneurysm. As
may be noted in FIG. 5, upon compression of the proximal loop
portion 125 of the tubular section 124 is caused to move into a
plane which extends generally parallel to the longitudinal axis of
the tubular section 124. Once the delivery catheter 128 is properly
positioned within a vessel adjacent the aneurysm, the deployment
catheter 104 may be moved distally relative to the delivery
catheter, or alternatively the delivery catheter 128 may be moved
proximally relative to the deployment catheter 104, thereby causing
the aneurysm cover device to move out of the distal end of the
delivery catheter and thereafter expand into contact with the walls
of the vessel and across the neck of the aneurysm. At this point
the hydraulic deployment system may be actuated to release the
aneurysm cover device. Alternatively, if the aneurysm cover device
is not positioned at a correct location, the deployment catheter
104 may be withdrawn proximally relative to the delivery catheter
to thereby withdraw the aneurysm cover device back into the
delivery catheter. As the aneurysm cover device is withdrawn into
the catheter it collapses to fit within the distal portion of the
delivery catheter 104. After the aneurysm cover device is withdrawn
back into the delivery catheter 104, the delivery catheter may be
moved into a new position and the aneurysm cover device may once
again be deployed.
[0035] As may be noted, because of the construction of the aneurysm
cover device which results in the proximal edge of the device lying
in a plane which is oblique to the longitudinal axis of the device,
the device collapses easily as the device is withdrawn back to the
delivery catheter 104. If this edge, or loop 126, were to be
positioned at right angles to the longitudinal axis of the aneurysm
cover device, as is the case with prior art devices, it would be
very difficult, if not impossible, to withdraw the device back into
the delivery catheter 128 once the device had been moved entirely
out of the distal end of the catheter. The "ramp" configuration at
the proximal edge of the aneurysm cover device 106 of the present
invention causes the aneurysm cover device to collapse easily
within the delivery catheter 120 thereby providing a device which
may be very easily repositioned after initially being placed at a
selected location.
[0036] Although a particular embodiment of the present invention
has been shown and described, modifications may be made to the
device and/or method of use without departing from the spirit and
scope of the present invention. The terms used in describing the
invention are used in their descriptive sense and not as terms of
limitations.
* * * * *